APPARATUS AND METHODS FOR ICP LEVEL CONTROL

BACKGROUND

[0001] This application claims the benefit of priority to U.S. Provisional Application Serial No. 63/011,540, filed April 17, 2020, which is incorporated by reference herein in its entirety.

BACKGROUND

[0002] Intracranial pressure (ICP) is the pressure exerted by a fluid, such as cerebrospinal fluid (CSF), in a skull of a patient. In an example, a patient normal ICP level can include an ICP level in a range of about 7 mmHg to about 15 mmHg. Intracranial hypertension, such as a state of increased ICP from a patient normal ICP level, can cause a patient symptom, such as headache, back pain, and papilledema in an eye of the patient. Intercranial hypotension, such as a state of decreased ICP from a patient normal ICP level, can cause a patient symptom, such as orthostatic headache, nausea, and blurred vision. Adjustment of ICP, such as toward a normal ICP level, can offer relief to the patient.

[0003] Jennings U.S. Patent No. 9,757,501 mentions methods and apparatus for lowering intracranial an intraspinal cord pressure.

[0004] Smith U.S. Publication No. 20140343599 mentions a device and systems to mitigate traumatic brain injuries.

[0005] Elvira PCT Publication No. WO 2017087556 mentions a traumatic brain injury protection device.

SUMMARY [0006] Glaucoma is an eye condition that can steal vision from millions of people around the world. The physiological conditions that give rise to glaucoma can include the difference between pressure in a patient eye, such as intraocular pressure (IOP), and pressure in the head of the patient, such as intracranial pressure (ICP), otherwise known as translaminar pressure difference (TPD). Non-pharmaceutical methods of adjusting IOP to treat an eye condition have been disclosed, however, non-pharmaceutical methods of adjusting ICP can offer an additional path to adjustment of TPD.

[0007] The present inventors have recognized, among other things, that there is a need in the art for apparatus and methods to adjust an indication of a physiological parameter, such as an indication of ICP in the patient, such as to diagnose, inhibit, or treat an eye condition. Adjustment of the indication of a physiological parameter can include a change in an indication of ICP level, such as an increase or decrease in ICP level such as to adjust TPD in the patient. This application describes means to adjust an indication of ICP of the patient to adjust TPD across a lamina cribrosa of the patient eye. In an example, the means to adjust can include a means for selectively applying an external force to a selected region of patient tissue, such as at least one of a selected region of the patient neck, such as the cervical region of the human spine including tissue in proximity to vertebra Cl through C7, or lower external portion of the patient, such as including at least one of tissue in the thoracic region of the patient (e.g., the patient chest) or tissue in the lumbar region of the patient (e.g., the patient abdomen or “belly”). In an example, the means to adjust can include at least one of an apparatus or a method, such as described in the following application. [0008] An apparatus to adjust translaminar pressure difference across a lamina cribrosa in a patient to diagnose, inhibit, or treat an eye condition of a patient eye of the patient can include a means for selectively applying at least one of a positive or negative external force to a selected region of a neck or lower external portion of the patient to adjust an intracranial pressure (ICP) of the patient to adjust a translaminar pressure difference across the lamina cribrosa to diagnose, inhibit, or treat the eye condition of the patient eye of the patient. [0009] This summary is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. The detailed description is included to provide further information about the present patent application. BRIEF DESCRIPTION OF THE DRAWINGS [0010] In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document. [0011] FIG. 1 shows an example of an apparatus to control an environment over a patient eye.

[0012] FIGS. 2A and 2B show a sectional side view of an example of a positive pressure cavity check valve 181 located in a cover, such as a flapper valve configured to control pressure in the cavity to a positive target cavity pressure level.

[0013] FIGS. 3A and 3B show a sectional side view of an example of a negative pressure cavity check valve located in a cover, such as a flapper valve configured to control pressure in the cavity to a negative target cavity pressure level.

[0014] FIG. 4 shows a sectional side view of an example of a check valve assembly, such as a flapper check valve assembly in an open position.

[0015] FIG.5A and 5B shows an example of a sectional side view of a positive pressure cavity check valve 181 and a negative pressure cavity check valve located in a cover.

[0016] FIG. 6A and 6B show an example of a protuberance and a recess located on the patient interface surface.

[0017] FIG. 7 shows an example of an apparatus that can control an eye environment over a patient eye, such as at least one of a left eye environment over the left patient eye or a right eye environment over the right patient eye. [0018] FIG. 8 shows an example of an apparatus that can independently control a left eye environment over a left eye of a patient and a right eye environment over a right eye of the patient, such as with a single pressure source.

[0019] FIG. 9 shows an example method for using the apparatus to adjust an indication of a physiological parameter in a patient, such as the patient associated with positive airway pressure (PAP). [0020] FIG. 10 shows an example block diagram of an example computing machine that can be used as control circuitry.

[0021] FIG. 11 shows an example of a mask assembly 199 including an eye cover and a nasal face mask.

[0022] FIG. 12 shows an example of a mask assembly 199 including an eye cover and a nose pillow mask.

[0023] FIG. 13 shows an example of a pressure invertor.

[0024] FIG. 14 shows an example of a mask assembly 199 including an eye cover and a nasal face mask with a transition portion.

[0025] FIG. 15 shows an example of a strapless nasal face mask.

[0026] FIG. 16 show an example of an adjustable airway tether as applied to a patient.

[0027] FIG. 17 shows an example of the slotted bridge.

[0028] FIG. 18 shows an example of the ratchet interface.

[0029] FIGS. 19A and 19B show front and side views of an example occlusive collar to adjust ICP level in a patient.

[0030] FIGS. 20A and 20B show front and side views of an example pressure collar to adjust ICP level in a patient.

[0031] FIGS. 21 A and 21B show front and side views of an example torso pressure vest to adjust ICP level in a patient.

[0032] FIG. 22 shows an example of an eye cover to adjust IOP level in a patient and an occlusive collar to adjust ICP level in the patient.

[0033] FIG. 23 shows an example of an eye cover to adjust IOP level in a patient and a pressure collar to adjust ICP level in the patient.

[0034] FIG. 24 shows an example of an eye cover and a nasal face mask with a transition portion to adjust IOP level in a patient and an occlusive collar to adjust ICP level in the patient.

[0035] FIG. 25 shows an example of an eye cover and a nasal face mask with a transition portion to adjust IOP level in a patient and an occlusive collar to adjust ICP level in the patient.

[0036] FIG. 26 shows an example of an eye cover to adjust IOP level in a patient and a torso pressure vest to adjust ICP level in a patient.

[0037] FIG. 27 shows an example of an eye cover and a nasal face mask with a transition portion to adjust IOP level in a patient and a torsion pressure vest to adjust ICP level in a patient.

[0038] FIG. 28 shows an example method to adjust an indication of a physiological parameter in a patient, such as an ICP level in the patient.

DETAILED DESCRIPTION

[0039] FIG. 1 shows an example of an apparatus 100, such as to adjust an indication of a physiological parameter in a patient eye related to PAP treatment, such as through control of an eye environment over a patient eye where the patient can be related to PAP therapy. Control of the eye environment can include at least one of the absorption of one or more therapeutic components into patient tissue, such as through adjustment of fluid composition in the eye environment, or the application of force to patient tissue, such as through adjustment of non-ambient pressure associated with the eye environment. In an example, the patient tissue can include any tissues of the patient affected by the eye environment, such as an anterior surface of the patient eye or patient skin exposed to the eye environment. The apparatus 100 can include a cover 110, a fluid regulator 120, a sensor 130, control circuitry 140, a pressure source 150, and an adjunct device 160.

[0040] The cover 110 can be sized and shaped to surround the patient eye and be spaced from the eye, such as without contacting the eye including the anterior surface of the eye. The cover 110 can be sized and shaped to surround and cover both patient eyes, such as the left eye and the right eye of a patient. In an example, the cover 110 can include a mask, such as a cover 110 similar in shape and function to a diving or snorkeling mask that can cover both the left eye and the right eye of the patient.

[0041] The cover 110 can include a lens portion 182 to allow a patient to see outward through the cover 110 or to allow observation of the eye, such as exterior structures of the eye including the cornea or intraocular structures of the eye including the retina, inward through the cover 110. The lens portion 182 can serve as a corrective lens for the patient, such as to correct an astigmatism of the eye. The lens portion 182 can include a lens blank, such as an A8 lens blank, that can be shaped as a prescription lens for the patient, such as to correct for refractive error in the eye. [0042] The lens portion 182 can include a replaceable lens portion 182, such as a first lens portion in the apparatus 100 can be interchanged with a second lens portion, such as to change the lens magnification presented to the patient.

In an example, lens magnification can be selected to allow for examination of the intraocular space of the eye including assessment of the retina and the choroid, such as for at least one of diagnostic or treatment purposes. The lens magnification can be selected to enhance the examination of the eye, such as to focus the lens portion 182 to enhance visualization of a portion of the eye. The inner surface of the lens portion 182 can be treated, such as with an anti-fog coating to prevent condensation from obscuring the view of the patient.

[0043] The lens portion 182 can be configured to control ambient light entering the cavity 112, such as to adjust or relieve a headache symptom. The lens portion 182 can include tinting, such as an auto-tinting lens to reduce the intensity of light to adjust or relieve the headache symptom.

[0044] The cover 110 can define an enclosed cavity 112, such as when the cover 110 is placed over the eye and against the patient. In an example, a peripheral edge of the cover 110 placed over the eye can contact at least a portion of patient tissue proximal to the eye socket, such as to form the cavity 112. The cavity 112 can be configured to maintain a gauge pressure between the cavity 112 and the surrounding atmosphere, such as to form a pressurizable cavity over the eye. The cavity 112 can define an enclosed cavity 112 over both eyes, such as when the cover 110 includes a mask located over the left and right patient eyes.

[0Q45] The cavity 112 can include a spatial volume, such as the spatial volume defined between an inner surface 188 of the cover 110, and patient tissue, such as including an anterior surface of the patient eye. The cavity 112 can contain a working fluid, such as a liquid or gaseous fluid, that can form at least part of an eye environment in contact with the patient tissue, such as including the anterior surface of the patient eye.

[0046] The cover 110 can include a first port 114. The first post 114 can be located in a surface of the cover 110, such as the first port 114 can extend from an outer surface 187 of the cover 110 to an inner surface 188 of the cover 110, to allow access to the eye environment in the cavity 112. The first port 114 can include a septum, such as a flexible septum located over the first port 114 to isolate the cavity 112 from the surrounding environment. The flexible septum can maintain a gauge pressure in the cavity 112, such as at least one of a positive or negative gauge pressure.

[0047] The flexible septum can include a resealable septum, such as a septum formed from a self-healing material including a self-sealing polymer material that can allow the insertion and withdrawal of instruments through the septum into the cavity 112 while maintaining a gauge pressure in the cavity 112. In an example, the resealable septum can allow a hypodermic needle to be inserted and withdrawn through the resealable septum while maintaining a gauge pressure (e.g. a positive or negative gauge pressure) in the cavity 112. For example, the resealable septum can allow for a hypodermic needle to be placed in proximity of the eye, such as to place a therapeutic fluid in contact with the eye, while maintaining a gauge pressure in the cavity 112.

[0048] The flexible septum can include a measurement septum, such as a septum to allow a sensor, such as the sensor 130, to sense an indication of the eye environment in the cavity 112 without contacting the eye environment. In an example, a pressure sensor can be in contact with the measurement septum covering the first port 114 of the cover 110, such as to sense an indication of working fluid pressure in the cavity 112 through the measurement septum.

[0049] The cover 110 can include a second port 116, such as extending from an outer surface 187 of the cover 110 to an inner surface 188 of the cover 110.

In an example, the second port 116 can place the cavity 112 in communication with the pressure source 150, such as with a conduit 117.

[0050] The apparatus 100 can include a cavity check valve 189. The cavity check valve 189 can be located on the apparatus 100 in communication with the cavity 112, such as on at least one of the cover 110 including any surface of the cover 110, the conduit 117, the control circuitry 140, or the pressure source 150. In an example, the cavity check valve 189 can be located in proximity to, such as in, on, or over, the first port 114.

[0051] The cavity check valve 189 can limit fluid pressure, such as in the cavity 112. In an example, the cavity check valve 189 can be used as a safety valve, such as to ensure that pressure in the cavity 112 will not exceed a cavity pressure level that could damage the patient eye. In an example, the cavity check valve 189 can limit pressure in the cavity 112, such as to a target cavity pressure level.

[0052] The cavity check valve 189 can include a cracking pressure, such as a characteristic of the cavity check valve 189 that can control initiation of fluid flow through the valve. In an example, the cracking pressure can describe an inlet pressure level of the cavity check valve 189, such as an inlet pressure level at which a fluid can initiate flow through the cavity check valve 189. Fluid pressure in the cavity 112 can be limited to the target cavity pressure level, such as by selecting or setting the cracking pressure of the cavity check valve 189 to equal the target cavity pressure level. In an example, when the fluid pressure in the cavity 112 is less than the cracking pressure of the cavity check valve 189, the cavity check valve 189 can assume a closed state, such as to prevent the flow of fluid from the cavity 112 to the surrounding atmosphere. When the fluid pressure in the cavity 112 is equal to or greater than the cracking pressure of the cavity check valve 189, the cavity check valve 189 can assume an open state, such as to allow a flow of fluid from the cavity 112 to the surrounding atmosphere.

[0053] The cavity check valve 189 can include a passive cavity check valve, such as a flapper valve or a poppet valve. The cracking pressure of the passive cavity check valve can be adjusted, such as by changing the dimensions of the passive cavity check valve or components of the passive cavity check valve. In an example, the cracking pressure of a flapper cavity check valve can be adjusted, such as by changing at least one of the flapper check valve dimensions (e.g., length, width, thickness), the flapper check valve constituent material (e.g. type of material, durometer of material, single or multi-ply material, stiffness of valve), or the flapper check valve hinge. In an example, the cracking pressure of a poppet cavity check valve can be adjusted, such as by changing at least one of the poppet valve dimensions (e.g., spring stiffness, poppet diameter).

[0054] FIGS. 2A and 2B show a sectional side view of an example of a positive pressure cavity check valve 181 located in a cover 110, such as a flapper valve configured to control pressure in the cavity 112 to a positive target cavity pressure level. FIG.2A shows the positive pressure cavity check valve 181 in the closed position. FIG.2B shows the positive pressure cavity check valve 181 in the open position. The positive target cavity pressure level can be specified, such as by a medical professional to treat, inhibit, or prevent an eye condition. The positive pressure cavity check valve 181 can be located on the cover 110, such as the outer surface 187 of the cover 110 to allow positive pressure working fluid in the cavity 112 at a pressure greater than the cracking pressure of the check valve to flow from the cavity 112 to the surrounding environment.

[0055] As shown in FIG. 2A, the cavity check valve 189 can assume a closed position, such as fluid cannot pass from the cavity 112 through the cavity check valve 189 to the surrounding environment. In the closed position, the apparatus 100 can support a positive gauge pressure in the cavity 112, such as a positive gauge pressure level less than the positive target cavity pressure level. The positive target cavity pressure level can include a positive safety pressure threshold, such as threshold pressure above which damage to the patient eye can occur. The positive target cavity pressure level can be controlled, such as by setting the cracking pressure of the positive pressure cavity check valve 181 to equal the positive target cavity pressure level.

[0056] As shown in FIG. 2B, the cavity check valve 189 can assume an open position, such as fluid can pass from the cavity 112 through the cavity check valve 189 to the surrounding environment, such as when the positive gauge pressure in the cavity 112 is equal to or greater than the positive target cavity pressure level. In the open position, the apparatus 100 can limit the positive gauge pressure environment in the cavity 112 to a pressure level approximately equal to the positive target cavity pressure level, such as to protect the eye from excessive fluid pressure.

[0057] FIGS. 3 A and 3B show a sectional side view of an example of a negative pressure cavity check valve located in a cover 110, such as a flapper valve configured to control pressure in the cavity 112 to a negative target cavity pressure level. FIG.3A shows the negative pressure cavity check valve in the closed position. FIG.3B shows the negative pressure cavity check valve in the open position. The negative target cavity pressure level can be specified, such as by a medical professional to treat, inhibit, or prevent an eye condition. The negative pressure cavity check valve can be located on the cover 110, such as the inner surface 188 of the cover 110 to allow fluid from the surrounding environment to flow into the cavity 112 from the surrounding environment. [0058] As shown in FIG. 3 A, the cavity check valve 189 can assume a closed position, such as ambient fluid cannot pass into the cavity 112 through the cavity check valve 189 from the surrounding environment. In the closed position, the apparatus 110 can support a negative gauge pressure environment in the cavity 112, such as a negative gauge pressure level greater than the negative target cavity pressure level. The negative target cavity pressure level can include a negative safety pressure threshold, such as threshold pressure below which damage to the patient eye can occur. The negative target cavity pressure level can be controlled, such as by setting the cracking pressure of the negative pressure cavity check valve to equal the negative target cavity pressure level. [0059] As shown in FIG. 3B, the cavity check valve 189 can assume an open position, such as ambient fluid can pass into the cavity 112 through the cavity check valve 189 from the surrounding environment, such as when the negative gauge pressure in the cavity 112 is equal to or less than the negative target cavity pressure level. In the open position, the apparatus 100 can limit the negative gauge pressure environment in the cavity 112 to a pressure level approximately equal to the negative target cavity pressure level, such as to prevent possible damage to the eye by excessive working fluid pressure.

[0060] As the patient eye condition changes, such as improves or degrades, a medical professional can adjust the prescribed treatment regimen, such as to change at least one of the positive target cavity pressure level or the negative target cavity pressure level. To adjust a target pressure level, the assembly 100 can include an adjustable valve. In an example, an adjustable valve can include a replaceable valve, such as a replaceable check valve assembly.

[0061] FIG. 4 shows a sectional side view of an example of a check valve assembly 177, such as a flapper check valve assembly in an open position. The apparatus 100 can include a check valve assembly 177, such as a replaceable check valve assembly 177 to adjust the target cavity pressure level in the cavity 112. In an example, the apparatus 100 with a first check valve assembly including a first cavity check valve with a first cracking pressure set to a first target pressure level, can be replaced with a second check valve assembly including a second cavity check valve with a second cracking pressure set to a second target pressure level. Changing from the first check valve assembly to the second check valve assembly can realize a change in pressure applied to the patient eye, such as a change in pressure specified in a prescribed patient treatment regimen, such as including a change in target cavity pressure level. [0062] The cavity check valve assembly 177 can include a base 171 with a first side 172, a second side 173 parallel to the first side 172, a base periphery 175 extending from the first side 172 to the second side 173, a base port 176 extending through the base 171 from the first side 172 to the second side 173, and a cavity check valve 189 located on the first side 172 over the base port 176, such as at least a portion of the base port 176. The cavity check valve assembly 177 can be located in the apparatus 100, such as in the cover 110 so that the base periphery 175 can be in contact with the cover 110, such as at least a portion of the surface of the port 114.

[0063] The check valve assembly 177 can be located on the apparatus 100 in communication with the cavity 112, such as on at least one of the cover 110 including any surface of the cover 110, the conduit 117, the control circuitry 140, or the pressure source 150. The cavity check valve assembly 177 can be located in contact with the cover 110, such as the base periphery 175 can be in contact with at least a portion of the cover 110, such as at least one of the surface of the port 114, the outer surface 187, or the inner surface 188.

[0064] The cavity check valve assembly 177, such as a positive pressure check valve assembly, can be configured to control pressure in the cavity 112 to a positive target cavity pressure level, such as the check valve assembly 177 can be located in the port 114 so that the cavity check valve 189 can be located outside of the cavity 112. The cavity check valve assembly 177, such as a negative pressure check valve assembly, can be configured to control pressure in the cavity 112 to a negative target cavity pressure level, such as the check valve assembly 177 can be located in the port 114 so that the cavity check valve 189 can be located inside the cavity 112.

[0065] FIGS.5 A and B show an example of a sectional side view of a positive pressure cavity check valve 181 and a negative pressure cavity check valve 183 located in a cover 110. The cover 110 can be located over the patient eye with the seal 119 in contact with the patient, such as to form the cavity 112 over the patient eye. The cavity 112 can be pressurized, such as to create a non-ambient pressure, such as at least one of a positive gauge pressure or a negative gauge pressure in contact with the patient, such as patient tissue.

[0066] In an example, the cavity 112 can be pressurized, such as by an external force applied to the cover 110. The external force can include a force separate from the apparatus 100, such as an external force applied by a hand of a user, such as a patient or a medical professional.

[0067] The external force can press the cover 110 against the patient tissue, such as to compress at least one of the seal 119 or patient tissue. Compression of at least one of the seal 119 or patient tissue can cause a reduction in cavity volume, such as to compress fluid in the cavity 112 resulting in increased cavity pressure, such as to create a positive gauge pressure in the cavity. The increased cavity pressure can be relieved, such as by releasing a quantity of fluid from the cavity 112 through at least one of the positive pressure cavity check valve 181 or leakage around or through the seal 119, such as to leave a reduced quantity of fluid remaining in the cavity 112.

[0068] The positive gauge pressure generated by the external force can be regulated, such as by selecting the cracking pressure of the positive pressure check valve 181 to equal a positive target cavity pressure level. A positive target cavity pressure level can be selected, such as to ensure that a negative gauge pressure exists in the cavity 112 after the external force is released. In an example, a positive target cavity pressure level can include a pressure level, such as equal to or less than the ambient pressure surrounding the cover 110. FIG. 5 A shows the positive pressure check cavity check valve 18 lin an open state, such as to regulate the pressure in the cavity 112 to the positive target cavity pressure level.

[0069] As the external force is released, at least one of the seal 119 or patient tissue can rebound from the compressed position, such as to cause an increase in cavity volume to decrease the pressure of the fluid remaining in the cavity 112, such as to create a negative gauge pressure in the cavity 112. The resulting negative gauge pressure can create a “suction” force in the cavity 112, such as to draw the cover 110 toward the patient, such as to generate an applied force against patient tissue. The applied force generated can act to stimulate the patient tissue, such as including patient tissue proximal to the applied force, such as to treat, inhibit, or prevent a headache symptom.

[0070] The magnitude of the force applied to the patient tissue can be regulated, such as by controlling the negative gauge pressure level in the cavity 112. In an example, the negative gauge pressure level can be regulated, such as by selecting the cracking pressure of the negative pressure cavity check valve 183 to equal a negative target cavity pressure level. The negative target cavity pressure level can be selected, such as to retain negative gauge pressure in the cavity 112 in a range of negative gauge pressure sufficient to treat, inhibit, or prevent the headache symptom. In an example, the range of negative gauge pressure can include a range, such as a range including at least one of a range of about -5 mmHg to about -15 mmHg, a range of about -15 mmHg to about -25 mmHg, a range of about -25 mmHg to about -35 mmHg, or a range of about -35 mmHg to about -45 mmHg.

[0071] The cover 110 can retain the working fluid against the patient, such as in contact with patient tissue including the anterior portion of the patient eye, to form the eye environment in the cavity 112. Exposure of the patient to the eye environment can stimulate patient tissue to adjust an indication of a physiological parameter in a patient eye, such as to adjust the indication of the physiological parameter in the eye of a patient related to PAP treatment. An indication of a physiological parameter can include at least one of an indication of the presence of a biomarker, such as the presence of a biomarker associated with increased IOP in the patient eye and sensed by a sensor 130, or an indication of blood vessel caliber, such as ocular blood vessel caliber.

[0072] Adjustment of the indication of the physiological parameter in the patient eye can include exposure of the patient eye to the composition of the working fluid in the eye environment to stimulate the patient eye, such as to facilitate absorption of the working fluid including a therapeutic component of the working fluid into the eye. In an example, a therapeutic component can include at least one of a vasodilator or a vasoconstrictor, such as to treat, inhibit, prevent, or adjust an indication of a physiological parameter in the patient eye. [0Q73] A constituent fluid can include a substance capable of vasoconstriction, such as ocular blood vessel vasoconstriction. In an example, a vasoconstrictor can include at least one of an alpha-adrenoceptor agonist, a vasopressin analog, epinephrine, norepinephrine, phenylephrine, dopamine, dobutamine, or other migraine and headache medications, such as at least one of a serotonin 5-hydroxytryptamine agonist or a triptan.

[0074] A constituent fluid can include a substance capable of vasodilation, such as ocular blood vessel vasodilation. In an example, a vasodialator can include at least one of a combination of nitrogen and nitric oxide, such as the nitric oxide constituent can be absorbed through a surface of the eye to promote vasodilation of blood vessels to adjust, such as treat, inhibit, or prevent, an indication of a headache symptom.

[0075] The working fluid can be composed of one or more constituent fluids, such as a combination of one or more liquids or gases. A working fluid can include a combination of two constituent fluids, such as a combination of gaseous nitric oxide and gaseous carbon dioxide. A constituent fluid can include a therapeutic fluid, such as a component of the constituent fluid can be absorbed through the eye to inhibit, treat, or prevent a headache symptom.

[0076] A therapeutic fluid can include a gaseous therapeutic fluid, such as at least one of carbon dioxide (CO2), oxygen (O2), nitric oxide (NO), ozone (O3), nitrogen (N2), helium (He), hydrocarbons including fluorocarbons and perfluorocarbons, sulfur hexafluoride, cannabinoids including tetrahydrocannabinol (THC) and cannabidiol (CBD), a combination of two or more gaseous therapeutic fluids, or the like. In an example, a therapeutic gas can include a mixture of at least one of carbon dioxide, oxygen, or nitric oxide, such as to treat, inhibit, or prevent an indication of a headache symptom. In an example, a therapeutic gas can include a mixture of nitric oxide and oxygen including a mixture of 50% nitric oxide and 50% oxygen, a mixture of helium and oxygen (also known as heliox), and Medical Air including Medical Grade Air USP, such as to treat, inhibit, or prevent an indication of a headache symptom. In an example, a mixture of therapeutic gases can include a mixture of nitric oxide and oxygen, such as a mixture of 50% nitric oxide and 50% oxygen including gases from The BOC Group pic under the tradename ENTONOX, such as to treat an indication of a headache symptom. In an example, a combination of therapeutic gases can include a mixture of helium and oxygen, such as a mixture of 21% oxygen and 79% helium, also known as heliox, such as to treat an indication of a headache symptom. In an example, a combination of therapeutic gases can include a mixture of at least one of fluorine or chlorine, such as to treat an indication of a headache symptom. In an example, a combination of therapeutic gases can include at least one of a mixture with a volume fraction of oxygen less than ambient air, such as the mixture with less than about twenty-one percent volume fraction O2, or a mixture with a volume fraction of oxygen greater than ambient air, such as the mixture with more than about twenty-one percent volume fraction O2, such as to treat an indication of a headache symptom.

[0077] The eye environment can be used to characterize a physiological state of the patient eye, such as the eye environment can include physiological constituents including biomarkers emitted from the eye or patient tissue within the cavity 112. In an example, the presence of an indication of a physiological parameter can cause the emissions of biomarkers, such as from the patient eye or patient tissue. Information sensed by the apparatus 100, such as biomarkers sensed from the working fluid in the cavity 112, can provide a medical professional with patient information, such as to diagnosis an eye condition associated with the patient eye or with the patient associated with PAP.

[0078] A mechanism of action to trigger a change in an indication of a physiological parameter, such as IOP level in the patient eye, can include decreased perfusion of the patient eye, such as decreased macular perfusion. In an example, the apparatus 100 can be used to sense an indication of blood flow in the patient eye, such as with a sensor 130, such as including a blood flow sensor. The control circuitry 140 can receive and process the sensed blood flow data, such as to determine a state of blood flow in the patient eye. A target cavity pressure, such as a blood flow target cavity pressure, can be calculated, such as based on the state of blood flow in the patient eye, and used to adjust pressure level in the cavity 112, such as to adjust the pressure level toward the blood flow target cavity pressure, such as to treat, inhibit, or prevent a headache symptom in the patient.

[0Q79] The eye environment can be defined by an environmental parameter, such as a characteristic of the working fluid in at least one of the cavity 112, a collar pressure cavity 324, a torso pressure cavity 354, or an abdominal pressure cavity 364. An environmental parameter can include at least one of working fluid flow in the cavity 112, such as working fluid volumetric flow rate into or out of the cavity 112, working fluid humidity in at least one of the cavity 112, the collar pressure cavity 324, the torso pressure cavity 354, or the abdominal pressure cavity 364, such as the relative humidity of the working fluid in the cavity 112, working fluid temperature in at least one of the cavity 112, the collar pressure cavity 324, the torso pressure cavity 354, or the abdominal pressure cavity 364, working fluid pressure in the cavity 112 (e.g., cavity pressure), such as the working fluid gauge pressure in at least one of the cavity 112, the collar pressure cavity 324, the torso pressure cavity 354, or the abdominal pressure cavity 364 and the ambient pressure of the environment surrounding the cavity, or working fluid composition in the cavity 112, such as working fluid composition measured by at least one of constituent fluid concentration or partial fluid pressure. An environmental parameter can include a parameter associated with the cover 110, such as at least one of tension in the anterior plate harness 194, tension in the posterior plate tether, or force applied to patient tissue, such as at the patient interface surface 119 A.

[0080] Adjustment of the indication of the physiological parameter can include exposure of the patient to non-ambient pressure associated with the eye environment in the cavity 112, such as to generate force against the patient tissue. As the cover 110 can be configured to contact patient tissue, the patient tissue can react the force applied by the cover 110 due to the eye environment and stimulate the patient tissue proximal to and in contact with the cover 110, such as to adjust the indication of the physiological parameter. In an example, the cover 110 can apply force to patient tissue due to non-ambient pressure in the cavity 112 and the force applied to patient tissue can be adjusted, such as by adjusting non-ambient pressure in the cavity 112. In an example, the working fluid in the cavity 112 can include a readily compressible fluid, such as a gaseous fluid with the same composition as ambient air.

[0081] The cover 110 can maintain a differential fluid pressure, such as a gauge pressure of the working fluid in the cavity 112, in contact with patient tissue. In an example, gauge pressure can be defined as the difference in pressure between the working fluid pressure in the cavity 112 and atmospheric pressure surrounding the cover 110.

[0082] A positive gauge pressure, such as where working fluid pressure in the cavity 112 is greater than atmospheric pressure, can create a force to stimulate patient tissue. In an example, the positive gauge pressure can create a compressive force on patient tissue exposed to the eye environment in the cavity 112, such as a compressive force proportional to the positive gauge pressure, while reducing compressive force on patient tissue in contact with the patient interface surface 119A, such as to cause the cover 110 to displace from its position against the patient tissue due to the force generated within the cavity 112.

[0083] The applied force can be related to the positive gauge pressure in the cavity 112. In an example, the applied force can include the force resulting from a positive gauge pressure, such as a range of positive gauge pressure including at least one of a range of about 5 mmHg to about 15 mmHg, a range of about 15 mmHg to about 25 mmHg, a range of about 25 mmHg to about 35 mmHg, or a range of about 35 mmHg to about 45 mmHg.

[0084] A negative (or “vacuum”) gauge pressure, such as where working fluid pressure in the cavity 112 is less than atmospheric pressure, can create an applied force on patient tissue. In an example, the negative gauge pressure can draw patient tissue into the cavity 112 to create a “pulling” force on patient tissue in the cavity 112, such as a “pulling” force proportional to the negative gauge pressure. In an example, the negative gauge pressure in the cavity 112 can cause the cover 110 to be drawn towards the patient, such as to compress patient tissue proximal to and in contact with the patient interface surface 119A. [0085] The applied force can be related to the negative gauge pressure in the cavity 112. In an example, the applied force can include the force resulting from a negative gauge pressure, such as a range of negative gauge pressure including at least one of a range of about -5 mmHg to about -15 mmHg, a range of about - 15 mmHg to about -25 mmHg, a range of about -25 mmHg to about -35 mmHg, or a range of about -35 mmHg to about -45 mmHg.

[0Q86] The applied force can be applied to the patient for a period of time, such as for a period of time sufficient to adjust an indication of a physiological parameter in the patient eye. In an example, applied force can be applied for a period, such as measured in days, weeks, months, or years.

[0087] The indication of the physiological parameter can be adjusted by the apparatus 100, such as by concurrently exposing the patient eye to the composition of the working fluid in the eye environment and non-ambient pressure of the eye environment. In an example, exposing the patient eye to the working fluid composition of the eye environment can facilitate absorption of at least a part of a therapeutic fluid into the patient eye. In an example, exposing patient tissue to non-ambient pressure applied with the eye environment can apply a therapeutic force to stimulate the patient tissue.

[0088] The indication of the physiological parameter associated with an eye condition can be affected by, such as concurrently affected by, the apparatus 100. In an example, a patient headache, such as a headache including an aura and post-aural migraine, can be accompanied by at least one of pain experienced by the patient or a decrease in ocular blood flow, such as a decrease in macular blood flow. Adjustment of the eye environment, such as by adjusting non ambient pressure in the cavity 112, can adjust force applied to patient tissue, such as at the patient interface surface 119A, to stimulate patient tissue including a nerve proximal to the patient tissue to adjust the indication of the physiological parameter. Adjustment of the eye environment, such as by adjusting non ambient pressure in the cavity 112, can adjust intraocular pressure (IOP), such as to adjust blood flow in the patient eye.

[0Q89] The apparatus 100 can be configured to adjust the eye environment, such as non-ambient pressure in the eye environment, to concurrently address at least one of the indication of the physiological parameter or the eye condition.

In an example, the apparatus can be configured to adjust non-ambient pressure toward at least one of a physiological parameter target cavity pressure, such as to adjust an indication of a physiological parameter, such as to adjust blood flow in an ocular blood vessel. In an example, the apparatus can be configured to adjust the eye environment including at least one of non-ambient pressure, such as toward at least one of a physiological parameter target cavity pressure or a target blood flow cavity pressure, or the electromagnetic environment, such as with the use of an electromagnetic (EM) energy transfer device (ETD) to generate EM energy for delivery to the patient eye, to adjust blood flow in the eye. For example, the EM ETD can generate energy in the visible light frequency range, such as pulses of energy in the visible light frequency range, to increase ocular blood flow including macular blood flow in the patient eye.

[0090] The cover 110 can include a seal 119, such as to provide a patient interface surface 119A between the cover 110 and the patient, such as to improve patient comfort when wearing the apparatus 100. The seal 119 can also serve as a barrier, such as to separate the eye environment in the cavity 112 from the surrounding environment. The seal 119 can attach to the periphery of the cover 110, such as at least a portion of the periphery of the cover 110. In an example, the seal 119 can extend continuously around the periphery of the cover, such as to form a sealing surface between the cover 110 and the patient 119 to separate the volume of the cavity 112 from the surrounding environment.

[0091] The cover 110, such as an eye cover 110, can interface with a positive airway pressure (PAP) mask. The eye cover 110 can be configured to be attached to or integrated with the PAP mask, such as to form a mask assembly 199. The mask assembly 199 can include the eye cover 110, such as to deliver pressure therapy to the patient eye to treat an eye disorder and the PAP mask, such as to deliver PAP therapy to the patient. Treatment of an eye disorder can include retaining non-ambient pressure in the cavity 112 over the patient eye, such as to control a physiological parameter in the patient eye.

[0092] The mask assembly 199 can be used by a patient, such as a patient receiving PAP therapy to treat a sleep disorder from a PAP device. The PAP device can include a device configured to deliver positive airway pressure to a patient, such as the airway of the patient for treatment of obstructive sleep apnea (OSA). The PAP device can include at least one of a continuous positive airway pressure (CPAP) device or a bi-level positive airway pressure (Bi-PAP) device. The PAP device can include a PAP mask.

[0093] FIG. 11 shows an example of a mask assembly 199 including an eye cover 110 and a nasal face mask 113. The nasal face mask 113 can be located in proximity to the patient nose and mouth, such as to cover at least one of the patient nose or the patient mouth to deliver PAP to the patient airway. The nasal face mask 113 can be attached to the cover 110, such as attached to the cover 110 with an airway tether 217. The airway tether 217 can include a means to couple the PAP mask to the cover 110, such as to locate the PAP mask with respect to the cover 110 to conform the mask assembly 199 to the patient. The airway tether 217 can include as at least one of a link or a strap. The nasal face mask 113 can be integrated with the cover 110, such as the nasal face mask 113 and the cover 110 can be joined together as a single continuous surface.

[0094] FIG. 12 shows an example of a mask assembly 199 including an eye cover 110 and a nose pillow mask 115. The nose pillow mask 115 can be located in proximity to the patient nose, such as to cover the patient nose to deliver PAP to the patient airway. The nose pillow mask 115 can be attached to the cover 110, such as with the airway tether 217. The nose pillow mask 115 can be integrated with the cover 110, such as the nose pillow mask 115 and the cover 110 can be joined together as a single continuous surface. In an example, the airway tether 217 can include a tether that can be adjustable.

[0095] FIG. 16 show an example of an adjustable airway tether 220 as applied to a patient. The adjustable tether 220 can be adjustable, such as to locate a mask including at least one of a nasal face mask 113 or a nasal pillow mask 115 (shown in FIG. 16) against a patient to improve patient comfort and PAP device effectiveness. The ratchet tether 220 can include a slotted bridge 190 and a ratchet interface 220.

[0096] FIG. 17 shows an example of the slotted bridge 190, such as a bridge to locate a left enclosure 110A relative to a right enclosure 110B and adjustably retain a PAP mask, including a nasal pillow mask 115, against a patient associated with PAP therapy. The slotted bridge 190 can include a bridge body 201 configured to locate the left enclosure 110A relative to the right enclosure 110B. The bridge body 201 can include a slot 202, such as a feature in the bridge body 201 configured to positively locate an airway tether 217, including the ratchet interface 220, against the patient.

[0097] FIG. 18 shows an example of the ratchet interface 220. The ratchet interface 220 can include a ratchet hinge assembly 221 including a first arm and a second arm, a horizontal ratchet receiver 222 configured to receive the first arm, and a vertical ratchet receiver 223 configured to receive the second arm. [0098] The ratchet hinge assembly 221 can include a first arm 225, a second arm 226, and a hinge 227, such as a hinge 227 configured to attach the first arm 225 to the second arm 226 and allow motion of the first arm 225 relative to the second arm 226.

[0099] The horizontal ratchet receiver 222 can include a tab 224, such as a tab 224 configured to interface with the slot 202 to positively locate the horizontal ratchet receiver 222 with respect to the bridge body 201. The horizontal ratchet receiver 222 can include a channel, such as a closed channel, configured to allow the first arm 225 to move relative to the receiver 222, such as to guide the first arm 225 in a direction parallel to the receiver 222.

[00100] The receiver 222 can include a ratchet mechanism, such as a mechanical interface between the first arm 225 and the receiver 222 that can allow the first arm 225 to be located with respect to the receiver 222, yet movably relocated with respect to the receiver 222 under a load applied to the first arm 225. In an example, the ratchet mechanism can include a linear ratchet mechanism, such as a first set of teeth located on the first arm 225 and a second set of teeth located on a surface of the closed channel, the second set of teeth configured to interact with the first set of teeth to prevent motion of the first arm 225 with respect to the receiver 222, yet allow relative motion between the first arm 225 and the receiver 222 under an applied load.

[00101] The vertical ratchet receiver 223 can include a channel, such as a closed channel, configured to allow the second arm 227 to move relative to the receiver 223, such as to guide the second arm 227 in a direction parallel to the receiver 223. The receiver 223 can include a ratchet mechanism, such as a mechanical interface between the second arm 227 and the receiver 223 that can allow the second arm 227 to be located with respect to the receiver 223, yet movably relocated with respect to the receiver 223 under a load applied to the second arm 227. In an example, the ratchet mechanism can include a linear ratchet mechanism, such as a first set of teeth located on the second arm 227 and a second set of teeth located on a surface of the closed channel, the second set of teeth configured to interact with the first set of teeth to prevent motion of the second arm 227 with respect to the receiver 223, yet allow relative motion between the second arm 227 and the receiver 223 under an applied load. [00102] The receiver 223 can include a mask interface 228, such as an connection point between the receiver 223 and a PAP mask. The mask interface 228 can be configured to allow a PAP mask to rotate with respect to the receiver 223, such as to provide a degree of freedom to align the PAP mask against the patient relative to the receiver 223. In an example, the mask interface 228 can include a revolute joint, such as a pin joint, or a spherical joint, such as a ball joint.

[00103] The eye cover 110 can include a left eye cover 110A configured to form a left cavity 112A over the left patient eye, such as to deliver or retain a left non-ambient pressure the left eye. The eye cover 110 can include a right eye cover 110B, configured to form a right cavity 112B of the right patient eye, such as to deliver or retain a right non-ambient pressure to the right eye.

[00104] The left non-ambient pressure and the right non-ambient pressure can be different, such as the left non-ambient pressure can be greater than or less than the right non-ambient pressure at a given moment in time to affect treat an eye disorder. In an example, the left and right non-ambient pressure can be greater than the ambient pressure, such as the ambient pressure surrounding the eye cover 110. In an example, the left and right non-ambient pressure can be less than the ambient pressure, such as the ambient pressure surrounding the eye cover 110.

[00105] The mask assembly 199 can include at least one of an eye cover 110 configured to form a cavity over the patient eye or a PAP mask configured to direct positive airway pressure (PAP) to the patient airway. In an example, the mask assembly 199 can be configured such that a pressure source 150, such as a pressure generator assembly including a positive airway pressure (PAP) generator, can be operatively coupled to the PAP mask, such as to direct PAP to the patient airway, and the same Pressure/flow generator can be operatively coupled to the eye cover 110 to direct non-ambient pressure, such as at least one or positive gauge pressure or negative gauge pressure, to the cavity 112.

[00106] The cover 110 can include an energy transfer device (or ETD), such as a device that can transfer energy from a first object to a second object. The ETD can operate to transfer energy to the patient, such as through at least one of the cover 110 or the seal 119, such as the patient interface surface 119 A. The transfer of energy can stimulate the patient tissue, such as to adjust the indication of a physiological parameter to a target level. An ETD can transfer energy, such as in the form of at least one of a transfer of thermal energy, a transfer of energy through application of a force including at least one of a static force, a quasi static force, or a dynamic force, a transfer of sonic energy, or a transfer of electromagnetic energy.

[00107] The ETD can include a temperature ETD, such as a device to affect a transfer of thermal energy through adjustment of temperature at the patient interface surface 119 A. The temperature ETD can include a heating ETD, such as a device that can increase the patient interface surface 119A from a first temperature to a second temperature where the second temperature is greater than the first temperature. In an example, a heating ETD can include a resistance coil, such as a coil in communication with the control circuitry 140. The coil can be attached to the apparatus 100 in proximity to the seal 119 and can be capable of converting electrical power, such as from the control circuitry 140, into thermal energy, such as to increase the temperature of patient tissue in proximity to the cover 110 via conduction of thermal energy from the coil to the patient through the patient interface surface 119 A.

[00108] The temperature ETD can include a cooling ETD, such as a device that can decrease the temperature of the patient interface surface 119A from a first temperature to a second temperature where the second temperature is less than the first temperature. In an example a cooling ETD can include at least one of a thermoelectric cooler (TEC) or a device using the Peltier effect, such as a TEC in communication with the control circuitry 140. The TEC can be attached to the apparatus 100 in proximity to the seal 119 and can be capable of converting electrical power, such as from the control circuitry 140, into a thermal sink, such as to reduce the temperature of patient tissue in proximity to the cover 110 via transfer of thermal energy from the patient to the TEC through the patient interface surface 119 A.

[00109] The ETD can include a vibration ETD, such as a device to generate vibration energy for transfer to the patient. The vibration ETD can include a rotating unbalance device, such as a rotating mass where the center of mass of the vibration ETD does not align with the center of rotation of the vibration ETD. In an example, the vibration ETD can include an electric motor with an eccentric rotating mass to generate vibrational energy. The vibration ETD can be in communication with the cover 110, such as to transmit vibrational energy from the vibration ETD to the patient through the patient interface surface 119 A. Transmission of vibration at different frequencies can be affected by adjusting the speed of the electric motor. In an example, the vibration ETD can include a piezoelectric element, such as a piezo uni-morph or piezo bi-morph in communication with the cover 110, to transmit vibration energy from the piezoelectric element to the patient through the patient interface surface 119 A. [00110] The ETD can include an acupuncture ETD, such as a device to locate and insert a needle into patient tissue. The acupuncture ETD can include the cover 110, such as the needle can be located on the patient interface surface 119A and oriented perpendicularly to the same, such as to penetrate the patient tissue when the patient interface surface 119A is brought into contract with the patient. Penetration of the needle into patient tissue can be controlled, such as by adjusting non-ambient pressure in the cavity 112 to vary force between the cover 110 and patient tissue at the patient interface surface 119A. In an example, negative cavity pressure can draw the cover 110 and patient interface surface 119A closer to the patient tissue, such as to cause the needle to penetrate the patient tissue. The depth of patient tissue penetration can be based on the level of negative cavity pressure applied to the cavity 112.

[00111] The needle can be in communication with another ETD, such as at least one of the temperature ETD, the vibration ETD, or an electrostimulation ETD to enhance an effect of the acupuncture ETD. The needle can include a dissolvable needle, such as a needle constructed from a therapeutic substance and configured to be inserted into patient tissue and subdermally absorbed into patient tissue, such as to treat, inhibit, or prevent an indication of a headache symptom.

[00112] Acupressure (or shiatsu) includes a form of therapy involving the application of pressure to patient tissue. In an example, acupressure can be applied to a patient to adjust patient perception of pain, such as to relieve patient pain. An acupressure pressure point can be defined as an area on the human body to which pressure can be applied, such as to adjust patient perception of pain.

[00113] The ETD can include an acupressure ETD to apply a localized pressure to an area of patient tissue, such as to generate a localized force on patient tissue. The acupressure ETD can be configured to apply localized force to an acupressure point such as concurrently to one or more acupressure points. An acupressure ETD can include at least one of a protuberance 191, such as a projection or “bump” protruding from the patient interface surface 119 A, or a recess 192, such as a depression or “hole” extending into the patient interface surface 119 A. In an example, the acupressure ETD can be applied to patient tissue while adjusting the eye environment, such as non-ambient pressure in the eye environment, to vary acupressure force applied to patient tissue.

[00T14] FIG. 6A and 6B show an example of a protuberance 191 and a recess 192, such as located on the patient interface surface 119 A. The protuberance 191 can include a feature, such as one or more features, that can be adjusted, such as to improve effectiveness of the acupressure ETD. The protuberance 191 can assume a generally circular shape, such as shown in FIG. 6a, or any non circular shape. The protuberance 191 can assume a generally biaxially symmetric cross section, such as shown in FIG. 7B, or any non-symmetric cross section. The height of the protuberance 191 can vary the level of force applied to the patient tissue. The height of the protuberance 191 can be defined as the distance from a reference surface, such as the patient interface surface 119A, to the maximum excursion of the protuberance 191 from the reference surface. In an example, the protuberance height can include a range of height, such as at least one of a range from about 0 mm to about 2 mm, a range from about 2 mm to about 5 mm, a range from about 5 mm to about 7.5 mm, or a range of greater than about 7.5 mm. The protuberance 191 can include a needle, such as an acupuncture needle.

[00115] The recess 192 can include a feature, such as one or more features, that can be adjusted, such as to improve effectiveness of the acupressure ETD. The recess 192 can assume a generally circular shape, such as shown in FIG. 6a, or any non-circular shape. The recess 192 can assume a generally biaxially symmetric cross section, such as shown in FIG. 6B, or any non-symmetric cross section. The depth of the recess 192 can vary the level of force applied to the patient tissue. The depth of the recess 192 can be defined as the distance from a reference surface, such as the patient interface surface 119 A, to the maximum excursion of the recess 192 from the reference surface. In an example, the recess 192 depth can include a range of depth, such as at least one of a range from about 0 mm to about 2 mm, a range from about 2 mm to about 5 mm, a range from about 5 mm to about 7.5 mm, or a range of greater than about 7.5 mm. [00116] The acupressure ETD can include a portion formed as an integral part of the patient interface surface 119 A. In an example, the protuberance 191 or the recess 192 can be incorporated as a feature into the mold or die used to form the patient interface surface 119 A.

[00117] The acupressure ETD can include a component separate from the patient interface surface 119 A. In an example, the protuberance 191 can include a molded protuberance component that can adhere to the patient interface surface 119 A, such as a molded protuberance component that can be bonded to a location on the patient interface surface 119A to precisely position the protuberance component with respect to an acupressure pressure point on the patient tissue. In an example, the protuberance 191 can in include a molded protuberance component that can be located over the acupressure pressure point on the patient tissue and then bonded to the patient interface surface 119A upon locating the cover 110 over the eye of the patient.

[00118] The acupressure ETD can include a flange cover, such as a flange cover configured overlay the patient interface surface 119 A. A flange cover can include any structure that can be located between the patient interface surface 119A and the patient. The flange cover can include a base structure, such as a sheet-like material with an adhesive on one or both sides of the sheet-like material, to overlay at least a portion of the patient interface surface 119A, and a protuberance structure including a protuberance 191, connected to the base structure. In an example, the flange cover can be configured to overlay the patient interface surface 119 A, such as to position the protuberance for contact with the patient tissue when the cover 110 is located against the patient. In an example, the flange cover can be adjusted with respect to the patient interface surface 119 A, such as to relocate the protuberance structure from a first position to a second position different from the first position to better align the protuberance structure with a location on the patient tissue, such as an acupressure pressure point on the patient.

[00119] The ETD can include a sonic ETD, such as a device attached to or in proximity of the cover 110, to generate energy in the sonic frequency range for transmission to the patient to stimulate patient tissue. The sonic frequency range can include a frequency range from about 2 Hertz (Hz) to about 20 kilohertz (kHz).

[00120] The ETD can include an electromagnetic (or EM) ETD, such as a device attached to or in proximity of the cover 110, to generate energy in the EM frequency range for transmission to the patient to stimulate patient tissue. The EM frequency range can include a radio frequency range including a frequency range from about 20 kHz to about 300 megahertz (MHz). The EM frequency range can include a microwave frequency range including a frequency range from about 300 MHz to about 300 gigahertz (GHz). The EM frequency range can include an infrared frequency range including a frequency range from about 300 GHz to about 430 tetrahertz (THz). The EM frequency range can include a visible light frequency range including a frequency range from about 430 THz to about 750 THz. The EM frequency range can include an ultraviolet frequency range including a frequency range from about 750 THz to about 3 petahertz (PHz).

[00121] In an example, an EM ETD can include a visible light ETD, such as a device capable of transmitting radiation in the visible light frequency range from the visible light ETD into the patient eye, such as to stimulate ocular patient tissue including retinal tissue to increase ocular blood flow including macular blood flow. The visible light ETD can generate pulses of visible light (or pulsed light), such as to stimulate the ocular tissue. In an example, the frequency of the pulsed light can vary in a range, such as in a frequency range of at least one of about 0.25 Hz to about 500 Hz, about 2 Hz to about 100 Hz, about 10 Hz to about 70 Hz, or from about 20 Hz to about 50 Hz.

[00122] Referring again to FIG. 1, the fluid regulator 120 can regulate the flow of fluid between two reservoirs, such as the fluid flow between the cavity 112 and a fluid source 170, such as a pressurized gas cylinder. The fluid regulator 120 can include a regulator valve, such as to regulate flow rates between the first and second reservoirs. The regulator valve can include a passive valve, such as a check valve that closes as pressure exceeds a critical value. In an example, a fluid regulator 120 with a check valve can be located between the cover 110 and a fluid source 170, such as if the pressure of the fluid source 170 exceeds a critical value, such as a pressure that can cause damage to a patient eye, the check valve can close to isolate pressure of the fluid source 170 from the patient eye, such as to protect the patient eye from excessive force. The regulator valve can include an active valve, such as an electrically-modulated valve including a servo valve, or a proportional valve, such as a piezo-actuated proportional valve. In an example, the regulator valve can receive a control signal, such as from the control circuitry 140, to modulate the position of the electrically-modulated spool with respect to the valve body, such as to regulate fluid flow through the electrically-modulated valve.

[00123] The fluid regulator 120 can attach to a fluid source 170, such as to regulate the flow of fluid from the fluid source 170 to the cavity 112. The fluid source 170 can include a fluid vessel, such as a storage container of pressurized gaseous fluid. The fluid source 170 can include a generator device, such as a device that concentrates or distills a constituent fluid from another fluid. In an example, a generator device can include a concentrator, such as an oxygen concentrator or a carbon dioxide concentrator. In an example, a generator device can include an atomizer, such as an ultrasonic humidifier or an aerosolizer, to transform a liquid therapeutic fluid, such as a miscible solution or colloidal suspension, into a gaseous working fluid, such as a therapeutic mist or fog. [00124] The fluid regulator 120 can communicate with apparatus 100, such as the fluid regulator 120 can communicate with the cavity 112. In an example, the fluid regulator 120 can be connected to the cover 110, such as with the conduit 117 in direct communication with the cover 110 through the second port 116. In an example, the fluid regulator 120 can be connected to the conduit 117 in communication with the cover 110 by a tube connector 118, such as a Y- connector. In an example, the fluid regulator 120 can be connected to the control circuitry 140, such as to receive a control signal from the control circuitry 140 to adjust the position of a servo valve.

[00125] The sensor 130 can sense an indication of the eye environment in the cavity 112, such as at least one of an indication of a characteristic of the working fluid in the cavity 112 or an indication of a physiological parameter of the patient. The sensor 130 can include sensor circuitry, such as sensor circuitry to receive an indication of a physical parameter sensed by the sensor 130 and process the received indication, such as into an indication including an electrical signal suitable to be received by at least one of the control circuitry 140 or the pressure source 150.

[00126] The sensor 130 can be located in proximity to the apparatus 100, such as in communication with the cavity 112 or at least partially attached to the patient. In an example, the sensor 130 can be separate from the apparatus 100. For example, the sensor 130 can include a handheld pressure gauge, such as to be pressed against a measurement septum located over the port 114 to sense an indication of working fluid pressure in the cavity 112. In an example, the sensor 130 can be in fluidic communication with the cavity 112, such as the sensor 130 can be located in the cavity 112 or on the control circuitry 140 in fluidic communication with the cavity 112. In an example, the sensor 130 can be at least partially attached to the patient, such as to a surface of the eye including an anterior surface of the eye or patient tissue covering the skull including tissue over the frontal, parietal, sphenoid, temporal, zygomatic, maxillary, occipital, and mandibular bones. For example, the sensor 130 can include an electroretinography device, such as part of which can include an electrode attached to patient tissue to sense an indication of electrical activity in the patient including electrical activity associated with a pattern electroretinography (or PERG) test.

[00127] The sensor 130 can be in electrical communication with the apparatus, such as at least one of the control circuitry 140 or the pressure source 150. The sensor 130 can provide at least one of continuous or periodic (e.g. intermittent) sensing of the working fluid, such as for monitoring an indication of the eye environment with the sensor 130, or an indication of the physiological parameter associated with the patient, such as IOP or CSFP.

[00128] The sensor 130 can include an IOP sensor, such as a device to sense an indication of an intraocular pressure (IOP) level in the eye. The IOP sensor can include at least one of an invasive IOP sensor, such as an IOP sensor implantable in an intraocular space of the eye to sense IOP including a sensor from Implandata Ophthalmic Products GmbH (Hannover, Germany) offered for sale under the trademark EYEMATE® or a non-invasive IOP sensor, such as an IOP sensor to sense IOP without implantation into the body including a contact lens-based sensor from Sensimed AG (Lausanne, Switzerland) offered for sale under the trademark SENSIMED TRIGGERFISH®.

[00129] The IOP sensor can include at least one of a continuous IOP sensor, such as an IOP sensor capable of continuous sensing of IOP level in the patient eye, or a periodic IOP sensor, such as an IOP sensor that capable of sensing IOP level in the patient eye at periodic or aperiodic intervals. In an example, the periodic IOP sensor can include a tonometer, such as a handheld tonometer designed for patient self-monitoring of IOP. The data sensed by the IOP sensor can be received by the control circuitry 140, such as to facilitate use of the apparatus 100.

[00130] The sensor 130 can include a cardiac sensor, such as to detect an indication of cardiac activity in a patient. An indication of cardiac activity can include at least one of an indication of systemic blood pressure, such as an indication of systolic and an indication of diastolic blood pressure, or an indication of heart rate.

[00131] The cardiac sensor can include a blood pressure (BP) sensor, such as a device to sense an indication of blood pressure level including systemic blood pressure level, in the patient. The BP sensor can include at least one of an invasive BP sensor, such as a BP sensor implantable within the patient, and a non-invasive BP sensor, such as a BP sensor that can sense BP without implantation within the patient body.

[00132] The sensor 130 can include a working fluid flow sensor, such as a device to sense an indication of working fluid flow including at least one of volumetric flow rate or mass flow rate into or out of the cavity 112. The sensor 130 can include a humidity sensor, such as a device to sense an indication of the relative humidity of the working fluid in the cavity 112. The sensor 130 can include a thermometer, such as a device to sense an indication of the temperature of the working fluid in the cavity 112. The sensor 130 can include a displacement sensor, such as a device to sense an indication of displacement including an optical coherence tomography device configured to sense displacement of structures associated with the patient eye.

[00133] The sensor 130 can include a pressure sensor, such as a device to sense an indication of working fluid pressure in the cavity 112. The pressure sensor can be located in proximity to the cavity 112, such as in communication with the cavity 112. In an example, the pressure sensor can include a cavity pressure sensor, such as a pressure sensor located in the cavity 112.

[00134] Static cavity pressure level in the cavity 112, such as the pressure level sensed by the pressure sensor when the pressure source 150 is not adjusting working fluid pressure in the cavity 112, can be the same at any location in the cavity 112. Dynamic cavity pressure level, such as the pressure level sensed by the pressure sensor when the pressure source 150 is adjusting working fluid pressure in the cavity 112, can vary depending on the location of the pressure sensor in communication with the cavity 112.

[00135] The sensor 130 can include a pressure sensor in combination with another indication, such as an indication of the operating state of the pressure source 150, to estimate a static cavity pressure level in the cavity 112. In an example, the pressure sensor, such as a pressure-flow sensor including a sensor that can measure both working fluid pressure (static and dynamic) and working fluid flow at a measurement location, can be located in proximity to the pressure source 150, such as an inlet port or an outlet port of the pressure source 150, to sense an indication of dynamic pressure at the pressure sensor location and include circuitry, such as sensor circuitry to receive an indication of the operation state of the pressure source 150 including an indication of flow rate (e.g., pump speed can be proportional to flow rate). The pressure-flow sensor can process at least one of the indication of dynamic pressure or the indication of flow rate, such as to form a control signal that can be received by the pressure source 150 to achieve a static cavity pressure level, such as a target pressure level, in the cavity 112. The control signal can be based on a relationship between the indication of dynamic pressure and the indication flow rate, such as a relationship between pressure and flow including the relationship described by a p-Q (e.g., pressure-flow) chart that can account for the operating characteristics of the pressure source 150. [00136] In an example, the pressure sensor can be located in proximity to the pressure source 150 The control circuitry 140 can be configured to receive an indication of dynamic pressure from the pressure sensor and an indication of the operation state of the pressure source 150 including an indication of pump speed. The control circuitry 140 can process at least one of the indication of dynamic pressure or the indication of pressure source 150 operation state, such as to form a control signal that can be received by the pressure source 150 to achieve a static cavity pressure level, such as a target pressure level, in the cavity 112. [00137] The sensor 130 can include a concentration sensor or a working fluid composition sensor, such as a device to sense an indication of a chemical constituent in the working fluid. In an example, the concentration sensor can be configured to sense an indication of the working fluid, such as a constituent in the working fluid. The constituent in the working fluid, such as the constituent in the working fluid delivered to the cavity 112, can include a therapeutic fluid. In at least one example, the working fluid composition sensor can sense a therapeutic fluid, such as at least one of (CO2), oxygen (O2), nitric oxide (NO), ozone (O3), nitrogen, helium (He), hydrocarbons including fluorocarbons and perfluorocarbons, sulfur hexafluoride, cannabinoids including tetrahydrocannabinol (THC) and cannabidiol (CBD), or a combination of therapeutic gases.

[00138] The sensor 130 can include a biomarker sensor, such as a device to sense an indication of a biomarker including a chemical constituent. A chemical constituent in the working fluid can include a biomarker, such as a biomarker emitted by the patient eye or sensed within the patient eye. A biomarker can suggest a physiological state of the eye, such as a state of distress where medical intervention can be required. The biomarker sensor can include a ketone, such as can be detected with a volatile gas sensor including a quartz crystal nanobalance (QCN) sensor, glucose, such as can be detected with an optical glucose sensor including an OCT imaging system, oxygen levels, such as can be detected with a non-invasive optical oxygen sensor, dissolved salts, such as can be detected with a salinity sensor, and vascular endothelial growth factor (or VEGF), such as can be detected with an aptamer-based sensor including the sensor and methods described in the publication “Flexible FET-Type VEGF Aptasensor Based on Nitrogen-Doped Graphene Converted from Conducting Polymer”, by Kwon, et at., ACS Nano, Vol.6, #2, pages 1486-1493, published February 2012, and incorporated herein by reference in its entirety. A biomarker can include at least one of an enzyme, such as matrix metallopeptidase 9 (MPP- 9), that can be detected with an enzyme sensor or a protein, such as brain- derived neurotrophic factor (BDNF), that can be detected with a protein sensor. [00139] The sensor 130 can include a biosensor, such as a sensor configured to sense an indication of a physiological parameter associated with a patient. A physiological parameter can include an indication of a physiological process associated with the patient, such as a process associated with a patient eye or process associated with physiological activity of the patient eye. In an example, a physiological parameter can include at least one of an indication of intraocular pressure (IOP) in the patient eye, such as an IOP level, an indication of cerebrospinal fluid pressure (CSFP) associated with the patient, such as a CSFP level, an indication of cardiac activity, such as at least one of systemic blood pressure or heart rate. A physiological parameter can include an indication of retinal activity, such as measured by an electroretinography device including a pattern electroretinography (or PERG) device.

[00140] The sensor 130 can include an imaging sensor to sense an indication of the eye, such as an intraocular portion of the eye. The imaging sensor can be located in proximity to the eye, such as attached to apparatus 100 including the cover 110 or exist separately from the apparatus including as a stand-alone device. In an example, the imaging sensor can include a camera, such as a single image capture camera or a multi-image capture camera including a video camera, such as the one or more captured images can be transferred to the apparatus 100 for image processing. In an example, the imaging sensor can include an optical coherence tomography (OCT) device.

[00141] The sensor 130 can include a blood flow sensor, such as an ocular blood flow sensor. The blood flow sensor can include an invasive blood flow sensor ocular imaging system, such as a blood flow sensor and imaging system that requires at least a part component of the system to be inserted into the patient. In an example, an invasive blood flow sensor an invasive ocular imaging system can include a fluorescein angiography system. [00142] The blood flow sensor can include a non-invasive ocular blood flow sensor, such as a blood flow sensor that does not require insertion into the patient. The non-invasive ocular blood flow sensor ocular imaging system can include a system to sense an indication of ocular blood flow from a patient or circuitry to process information from the patient to yield an indication of ocular blood flow. An indication of ocular blood flow can include at least one of peak systolic blood velocity (PSV), end diastolic blood velocity (EDV), mean blood velocity (MV), resistivity index (RI), such as RI = (PSV - EDV) / PSV, or pulsatility index (PI), such as PI = (PSV - EDV) / MV.

[00143] The non-invasive ocular blood flow sensor ocular imaging system can include an ocular energy source, such as to radiate illuminate a tissue including ocular tissue with energy to elicit a response from the tissue that can be sensed with a sensor. The ocular tissue can be illuminated with electromagnetic (EM) energy generated by the ocular energy source, such as EM energy in a frequency range from about 3 hertz (Hz) to about 300 exahertz (EHz). In an example, an ocular energy source can include a diffuse light source, such as generated by a light bulb, and a collimated light source, such as generated by a laser diode. [00144] The non-invasive ocular blood flow sensor ocular imaging system can include an ocular blood flow sensor, such as to sense energy radiated from ocular tissue including energy elicited from the ocular tissue by illuminating the ocular tissue with an energy source. An ocular blood flow sensor can be configured to sense EM energy, such as EM energy in a frequency range from about 3 hertz (Hz) to about 300 exahertz (EHz).

[00145] In an example, the ocular blood flow sensor can include an ultrasonic sensor, such as an ultrasonic sensor configured to sense EM energy in a frequency range from about 3 Hz to about 300 gigahertz (GHz) including a frequency range from about 20 kilohertz (kHz) to about 400 kHz and a frequency range of about 1 megahertz (MHz) to about 18 MHz.

[00146] The ocular blood flow sensor can include a charge coupled device (CCD) sensor such as including a complementary metal-oxide-semiconductor (CMOS) sensor. The CCD sensor can be configured to sense EM energy in a frequency range, such as at least one of a range from about 300 GHz to about 300 exahertz or EHz including a frequency range from about 300 GHz to about 400 tetrahertz or THz (infrared radiation, corresponding to wavelengths of about 1,000 micrometers to about 750 nanometers or nm), a frequency range from about 400 THz to about 800 THz (visible light, corresponding to wavelengths of about 750 nm to about 375 nm), and a frequency range from about 800 THz to about 30 petahertz or PH Z (ultraviolet radiation, corresponding to wavelengths of about 375 nm to about 10 nm).

[00147] The non-invasive ocular blood flow sensor ocular imaging system can include a color doppler imaging (CDI) system, such as a medical ultrasonic imaging system with at least one of an ocular energy source, such as an ultrasonic transducer, an ocular blood flow sensor, such as an ultrasonic receiver, or a combination of ocular energy source and ocular blood flow sensor, such as an ultrasonic transceiver. In an example, the CDI system can be configured with an energy source capable of generating EM energy at a frequency of about 6.5 MHz.

[00148] The non-invasive ocular blood flow sensor system ocular imaging can include a laser speckle flowgraphy (LSF) or laser speckle contrast imaging (LSCI) system. In an example, the LSF system can be configured with an energy source capable of generating EM energy at a frequency of about 361 THz (corresponding to a wavelength of about 830 nm). In an example, the LSF system can include a system from Nidek Co., Ltd. (Aichi, Japan) offered for sale under the tradename LSFG-Retflow.

[00149] The non-invasive ocular blood flow sensor system can include a laser Doppler flowmeter (LDF), such as a confocal scanning laser Doppler flowmetry (CSLDF) system. In an example, the LDF system can be configured with an energy source capable of generating EM energy at a frequency of about 384 THz (corresponding to a wavelength of about 780 nm). In an example, the CSLDF system can include a system from Heidelberg Engineering GmbH (Heidelberg, Germany) offered for sale under the tradename Heidelberg Retina Flowmeter. [00150] The non-invasive ocular blood flow sensor system can include an ocular coherence tomography angiography (OCTA) system. In an example, the function of an ocular coherence tomography (OCT) system can be enhanced, such as by placing an OCTA module in communication with the OCT system.

An OCTA module can include control circuitry that can execute coded instructions to cause the OCT system to repeatedly scan a section of eye tissue, store each scan of eye tissue into memory, and process the stored scans to identify differences between scans, such as to generate an indication of ocular blood flow. In an example, the OCTA system can include at least one of an OCT system from Heidelberg Engineering GmbH (Heidelberg, Germany) offered for sale under the tradename Spectralis or an OCTA module from Heidelberg Engineering GmbH (Heidelberg, Germany) offered for sale under the tradename Spectralis OCT Angiography Module.

[00151] The non-invasive ocular blood flow sensor system can include a laser doppler velocimetry (LDV) system. In an example, the LDV system can be configured with an energy source capable of generating EM energy at a frequency of about 444 THz (corresponding to a wavelength of about 675 nm). [00152] The non-invasive ocular blood flow sensor system can include a retinal vessel analyzer (RVA) system. The RVA system can include a system that illuminates the eye vessel and senses at least one of a coefficient of light reflection or a coefficient of light absorption.

[00153] The non-invasive ocular blood flow sensor system can include a doppler optical coherence tomography (DOCT) system with a collimated light source, such as a collimated light source configured to illuminate ocular tissue and a CCD sensor configured to receive the collimated light reflected from the ocular tissue. In an example, the DOCT system can be configured with an energy source capable of generating EM energy at a frequency of about 356 THz (corresponding to a wavelength of about 841 nm). In an example, the DOCT system can include the DOCT system from Optovue, Inc (Fremont, CA) offered for sale under the tradename RTVue.

[00154] The non-invasive ocular blood flow sensor system can include at least one of a retinal functional imager (RFI) system, a pulsatile ocular blood flow (POBF) system, a fundus pulsation amplitude (FPA) system, a fluorescein and Indocyanine Angiography (FA, ICG) system, a color doppler imaging (CD I) system, a retinal oximetry system, a magnetic resonance imaging (MRI) system, a magnetic resonance imaging (MRI) system, a blue light entoptoscopy) system, a frequency domain optical coherence tomography (FD-OCT) system, an angiography system, or a Split Spectrum Amplitude Decorrelation Angiography with Optical Coherence Tomography (SSADA-OCT) system.

[00155] The non-invasive ocular imaging system can include an electroretinography (ERG) system, such as at least one of a full field, multifocal, pattern, or visual evoked potential (VEP) electroretinography system. In an example, the ERG system can be configured with an energy source capable of generating EM energy at a frequency of about 440 THz (corresponding to a wavelength of about 680 nm or greater). In an example, the ERG system can include a system from Diopsys, Inc. (Pine Brook, NJ) offered for sale under the tradename Diopsys Nova-ERG.

[00156] The ERG system can include a recording electrode, such as to sense an indication of electrical activity in the eye, including at least one of a neural and a non-neuronal cell in the retina, from stimulus applied to the eye including EM energy such as visible light. In an example, the recording electrode can be used with an ERG system to measure an indication of electrical activity in the eye, such as a pattern electroretinography (PERG) test as an indication of ocular blood flow. The recording electrode can include at least one of an electrode that can be in contact with the eye, such as an electrode attached to a contact lens and configured for contact with a surface of the eye, or an electrode in proximity to the eye, such as an electrode that can be located on the lower eye lid of an eye. [00157] The non-invasive ocular imaging system can include a retinal functional imaging (RFI) system. The RFI system can be configured with an energy source capable of generating EM energy at a frequency of about 547 THz (corresponding to a wavelength of about 548 nm). In an example, the RFI system can include a system from Optical Imaging, Ltd. (Rehovot, Israel) offered for sale under the tradename RFI 3000. The RFI system can be configured with an energy source capable of generating EM energy at a frequency of about 666 THz (corresponding to a wavelength of at least 450 nm). In an example, the RFI system can include a system from OcuScience Inc. (Ann Arbor, MI) offered for sale under the tradename OcuMet Beacon.

[00158] The sensor 130 can include a force sensor, such as to sense force applied to patient tissue. The force sensor can located on the cover 110, such as to sense applied force between the cover 110 and patient tissue, such as when the cover 110 is located over the patient eye. The force sensor can be positioned at a specified location on the cover 110, such as to sense force applied to patient tissue at the location, or distributed around the peripheral edge of the cover 110, such as to sense force applied to patient tissue at any location around the periphery of the cover 110. In an example, the force sensor can be positioned between at least one of the cover 110 and the seal 119 or the patient interface surface 119A and patient tissue.

[00159] The sensor 130 can include a patient response sensor, such as to receive input from a patient using the apparatus 100. The patient response sensor can be in communication with the control circuitry 140, such as wired or wireless communication, to transfer data received from the patient to the control circuit 140 for at least one of data processing or data recording. Patient input can include an indication of patient perception, such as effectiveness of an applied therapeutic regimen to adjust an indication of an indication of a headache symptom. Patient input can include patient commands, such as with regards to operation of the apparatus 100. In an example, the patient response sensor can adjust a parameter of the apparatus 100, such as an environmental parameter to increase or decrease the parameter, in response to patient input. [00160] The patient response sensor can include a device to collect patient input, such as at least one of a smart device running an app configured to receive patient input and in communication with the control circuitry 140 or a fob device, such as an electro/mechanical device in communication with the control circuitry 140. The patient response sensor can include one or more selection buttons, such as to collect patient input. In an example, the one or more selection buttons can allow a patient to communicate an indication of patient perception, such as in response to an applied therapeutic regimen, to the control circuitry 140.

[00161] The sensor 130 can include a positive airway pressure (PAP) sensor, such as to sense an indication of PAP. The indication of PAP can include an indication associated with a PAP therapy, such as at least one of an indication of the type of PAP therapy (e.g., continuous PAP, bi -level PAP, or other type of PAP), an indication of whether the PAP therapy is in use, an indication of at least one of the frequency or duration of use of the PAP therapy, or at least one of a historical or a current PAP therapy indication. The indication of PAP can include a physiological indication in the patient associated with PAP therapy, such as elevated patient intrathoracic pressure relative to patient intrathoracic pressure without exposure to PAP therapy.

[00162] The indication of PAP can include a relationship with PAP applied to a patient, such as a PAP level applied to the patient to treat a sleep disorder. The relationship can include a relationship between the indication of PAP and the non-ambient pressure applied to the cavity 112, such as the non-ambient cavity pressure level applied to the cavity 112.

[00163] The relationship can include a phase relationship between PAP applied to the patient and non-ambient pressure applied to the cavity 112. PAP applied to the patient can vary periodically over time, such as the patient can experience a maximum applied PAP and a minimum applied PAP, such as a maximum and minimum that can correlation with patient respiration patterns. In an example, the phase relationship can include a phase relationship between applied PAP, such as at least one of maximum applied PAP or minimum applied PAP, and the non-ambient pressure applied to the cavity, such as at least one of maximum applied non-ambient pressure level or minimum applied non-ambient pressure level. The phase relationship can be characterized by a time shift, such as the time shift between the application of a maximum applied PAP to the patient and the application of a maximum applied non-ambient pressure to the cavity 112. In an example, time shift can include the length of time between the occurrence of a first event, such as application of a maximum applied PAP, and a second event, such as application of maximum non-ambient pressure to the cavity 112.

[00164] The time shift can include the delay in time between at least one of an application of a maximum applied PAP to a patient and an application of a maximum applied non-ambient pressure to the cavity 112 or an application of a maximum applied non-ambient pressure to the cavity 112 and an application of a maximum applied PAP to the patient. The time shift can include a phase relationship such as a phase shift. The phase shift can specify the time shift between two periodic events. In an example, the phase shift can include the delay between the periodic application of maximum applied PAP to the patient and the periodic application of a maximum applied non-ambient pressure to the cavity 112. The phase shift can include a specified relationship between the periodic application of maximum applied PAP and maximum applied non ambient pressure, such as an in-phase relationship or an out-of-phase relationship.

[00165] The PAP sensor can include a pressure sensor, such as a pressure sensor configured to sense at least one of an indication of inspiratory positive airway pressure (IPAP) applied to the patient or an indication of expiratory positive airway pressure (EPAP) exuded from the patient. The PAP sensor can include a volume sensor, such as a device that can sense an indication of fluid volume applied to the patient, such as at least one of an indication of inspiratory volume applied to the patient or and indication of expiratory volume exuded from the patient.

[00166] The sensor 130 can include a circadian rhythm (CR) sensor, such as to sense an indication of CR associated with a patient. The CR sensor can include at least one of a clock, such as to sense an indication of time; a light sensor, such as to sense an indication of level or intensity of visible light proximal to the patient, or a thermometer, such as to sense an indication of patient core temperature.

[00167] The sensor 130 can include a patient body position (PBP) sensor 131, such as to sense an indication of patient position associated with a patient. The PBP sensor 131 can include an inclinometer attached to the patient, such as an instrument configured to sense an indication of PBP with respect to a reference frame. In an example, the indication of PBP can include an angle measured with respect to a horizontal axis parallel to the ground, such as sensed with an inclinometer aligned with a medial axis of the patient and located on the torso of the patient. For example, the inclinometer can sense an angle of about 90 degrees with respect to the horizontal axis when the patient stands in a vertical, upright position and an angle of about 0 degrees with respect to the horizontal axis with the patient lies in a supine position. In an example, the indication of PBP can include an angle measured about the medial axis of the patient, such as sensed with an inclinometer located perpendicular to the medial axis of the patient and located proximally to the head of the patient. For example, the inclinometer can sense an angle of about 0 degrees with respect to the patient medial axis when the patient assumes a supine position and about 180 degrees with respect to the patient medial axis when the patient lies in the prone position. [00168] The PBP sensor 131 can include at least one of a force sensor or a pressure sensor, located between the patient and a surface, such as to sense at least one of an indication of force or an indication of pressure between the patient and the surface. In an example, the PBP sensor 131 can include a force sensor located on the patient head, such as to determine the rotational position of the patient head about the medial axis of the patient head. A force sensor located on the left side of the head can indicate the patient has assumed a left lateral decubitus position, such as during patient repose. A force sensor located on the right side of the head can indicate the patient has assumed a right lateral decubitus position, such as during patient repose.

[00169] The PBP sensor 131 can include at least one of a torso sensor, such as to sense an indication torso position with respect to a horizontal reference surface, or a force sensor located on the patient head. In an example, the torso sensor can indicate patient torso position, such as to indicate whether the patient is standing (e.g., perpendicular to the horizontal surface) or laying down (e.g., parallel to the horizontal surface).

[00170] The PBP sensor 131 can include a sensor system, such as one or more PBP sensors 131 configured for coordinated sensing. An indication of body position can include a distance, such as the relative elevation of one portion of a patient body to another portion of the patient body. In an example, the PBP sensor 131 can include a location sensor including a GPS sensor, such as at least two location sensors, to determine the vertical distance between two locations on the body of the patient. For example, a first GPS sensor can be located at a first location on a patient, such as the patient waist, and a second GPS sensor can be located at a second location on the patient, such as the patient head. Data, such as an indication of location including an indication of vertical distance from a datum, can be sensed from the GPS sensors to locate each of the first and second GPS sensors in three-dimensional space.

[00171] Patient body position can be determined from a relationship between the first and second GPS sensors. In an example, patient body position can be determined by identifying the vertical difference between the second GPS sensor, such as located on the patient head, and the first GPS sensor, such as located on the patient waist. For example, the vertical difference between the second GPS sensor, such as located on the patient head, and the first GPS sensor, located on the patient waist, can provide an indication of the location of the head with respect to the waist, such as to determine how much higher the head is relative to the spine. In an example, patient body position can be determined by identifying the angle the patient body makes relative to a horizontal datum. For example, the angle the patient body makes with respect to a bedding surface, such as a horizontal bedding surface, can be approximated by a ratio, such as the vertical difference between the first and second GPS sensors and the horizontal distance between the first and second GPS sensors.

[00172] The control circuitry 140 can facilitate and coordinate operation of the apparatus 100. The control circuitry 140 can be coupled to, such as in communication with, at least one of the cover 110, such as an ETD associated with the cover 110, the fluid regulator 120, the sensor 130, the pressure source 150, the fluid source 170, or an adjunct device 160.

[00173] The control circuitry 140 can facilitate and coordinate operation of at least one of an occlusive collar 310, a pressure collar 320, or a pressure vest 350. The control circuitry 140 can be coupled to, such as in communication with, at least one of the cover 110, an occlusive collar 310, a pressure collar 320, a pressure vest 350, the sensor 130, or the pressure source 150.

[00174] The control circuitry 140 can include a data interface. The data interface can be configured to receive a signal, such as at least one of an indication of the eye environment sensed by the sensor 130. The control circuitry 140 can process the received signal, such as into a processed signal, and transmit the processed signal to one or more components of the apparatus 100, the occlusive collar 310, the pressure collar 320, or the pressure vest 350.

[00175] The data interface can be configured to transmit a signal, such as at least one of a remote data storage device or other computing machine 1400 remote from any one of the apparatus 100, the occlusive collar 310, the pressure collar 320, or the pressure vest 350 for subsequent data processing and data analysis.

[00176] The control circuitry 140 can be in communication with the fluid regulator 120, such as to adjust the position of the regulator valve to control the working fluid composition. The control circuitry 140 can be in communication with the sensor 130, such as to receive and process an indication of the eye environment including sensed data from the sensor 130. The control circuitry 140 can be in communication with the pressure source 150, such as to generate a pressure source control signal to adjust at least one of working fluid pressure or working fluid flow in the apparatus 100.

[00177] The control circuitry 140 can provide a communication interface, such as to allow for a user to operate and interact with at least one of the apparatus 100, the occlusive collar 310, the pressure collar 320, or the pressure vest 350. The communication interface can include a graphical user interface (or GUI), such as communicate information to the user including information on at least one of the apparatus 100, the occlusive collar 310, the pressure collar 320, or the pressure vest 350 (e.g., readout of sensed indications, fault status, etc) or receive information from the user. Information received from the user can include at least one of information to manage basic functionality of at least one of the apparatus 100, the occlusive collar 310, the pressure collar 320, or the pressure vest 350, such as cycling the power to the apparatus 100, or an indication of user preference, such as operational parameters including target levels to define therapeutic protocols and safety parameter such as maximum and minimum limits. In an example, the communication interface can receive a safety pressure level, such as at least one of a maximum or minimum pressure level in the cavity 112 selected by the user to prevent damage to the patient eye, adjusting the working fluid pressure delivered to the cavity 112, or setting a target pressure level in the cavity 112. In an example, the communication interface can receive a safety pressure level, such as at least one of a maximum or minimum pressure level in at least one of the collar pressure cavity 324, a torso pressure cavity 354, or an abdominal pressure cavity 364 selected by the user to prevent damage to the patient tissue, adjusting the working fluid pressure delivered to the pressure cavity, or setting a target pressure level in at least one of the collar pressure cavity 324, a torso pressure cavity 354, or an abdominal pressure cavity 364. [00178] The control circuitry 140 can include a digital signal processing (DSP) circuit, such as to receive and record an indication including an indication of the eye environment sensed by the sensor 130, such as at least one of an environmental parameter or a physiological parameter. The indication of the eye environment or an environment parameter can be monitored and recorded by the control circuitry 140 for a duration, such as for a period of seconds, minutes, hours, days, years, or for the lifetime of the patient.

[00179] The control circuitry 140 can include a processing unit, such as a programmable central processing unit (CPU) including a microcontroller. The microcontroller can be configured to execute instructions to implement methods of using the apparatus 100, such as to treat, inhibit, prevent, or adjust an indication of an indication of a headache symptom experienced by a patient.

The microcontroller can be configured to execute instructions to implement methods of using at least one of the occlusive collar 310, the pressure collar 320, or the pressure vest 350, such as to treat, inhibit, prevent, or adjust at least one of an indication of ICP, an indication of CSFP, or an indication of a relationship between IOP and at least one of ICP or CSFP, such as an indication of translaminar pressure difference (TPD). In an example, the microcontroller can be a component of a computing machine, such as a computing machine 1400. [00180] The microcontroller can be configured as a control circuit, such as a feedback control circuit. The feedback control circuit can receive information, such as at least one of an indication sensed by the sensor 130, an indication of user preference from the communication interface, or an indication of a processed signal including a signal processed by the microcontroller. The microcontroller can process the received information, such as to form a control signal, such as a pressure source control signal.

[00181] In an example, the pressure source control signal can be based on an indication of cavity pressure, such as pressure in the cavity 112, to achieve a target pressure level in the cavity 112. The pressure feedback control circuit can receive an indication of working fluid pressure in the cavity 112, such as an indication of cavity pressure level sensed by the sensor 130 including a pressure sensor in communication with the cavity 112. The pressure feedback control circuit can process the received indication of pressure level to form a control signal, such as a control signal to adjust the pressure source 150 to achieve the target pressure level in the cavity 112. [00182] In an example, the pressure source control signal can be based on an indication of non-optical cavity pressure to achieve a target pressure level in the non-optical cavity, such as at least one of an indication of collar cavity pressure level toward a target collar pressure level in the collar pressure cavity 324, an indication of torso cavity pressure level toward a target torso pressure level in the torso pressure cavity 354, or an indication of abdominal cavity pressure level toward a target abdominal pressure level in the abdominal pressure cavity 364. The pressure feedback control circuit can receive an indication of working fluid pressure in the non-optical cavity, such as an indication of non-optical cavity pressure level sensed by the sensor 130 including a pressure sensor in communication with at least one of the collar pressure cavity 324, the torso pressure cavity 354, or the abdominal pressure cavity 364. The pressure feedback control circuit can process the received indication of pressure level to form a control signal, such as a control signal to adjust the pressure source 150 to achieve the non-optical target pressure level, such as at least one of the target collar pressure level in the collar pressure cavity 324, the target torso pressure level in the torso pressure cavity 354, or the target abdominal pressure level in the abdominal pressure cavity 364.

[00183] The microcontroller can be configured as a pressure feedback control circuit, such as to generate a control signal for the pressure source 150 (e.g., a pressure source control signal) to adjust pressure level in the cavity 112. The pressure source control signal can be based on an indication sensed by a sensor 130, such as the difference between an indication sensed by a sensor 130 and the target cavity pressure level.

[00184] The microcontroller can be configured as a pressure cavity feedback control circuit, such as to generate a pressure cavity feedback control signal to adjust pressure level in a pressure cavity, such as at least one of a collar pressure cavity 324, a torso pressure cavity 354, or an abdominal pressure cavity 364.

The pressure cavity feedback control signal can be based at least in part on an indication sensed by a sensor 130, such as at least one of an indication of the pressure cavity pressure level, such as sensed by a pressure sensor in communication with the pressure cavity, an indication of intraocular pressure (IOP), or an indication of at least one of intracranial pressure (ICP) or cerebrospinal fluid pressure (CSFP).

[00185] The microcontroller can be configured as a positive airway pressure (PAP) feedback control circuit, such as to generate a PAP feedback control signal to adjust pressure level in the cavity 110 based at least in part on an indication of PAP. The indication of PAP can include an indication associated with a PAP therapy, such as a PAP parameter associated with a PAP device. In an example, a PAP parameter can include at least one of a PAP pressure level, such as at least one of an inspiratory pressure or an expiratory pressure, sensed by a pressure sensor including a pressure sensor associated with the PAP device. [00186] The indication of PAP can include a PAP state, such as to indicate an operational state of the PAP device. In an example, an operational state can include at least one of the type of PAP device used, such as CPAP, Bi-PAP, or other PAP device, PAP energization (e.g., PAP on or off), or an indication of PAP use, such as at least one of use frequency, use duration, or other historic or current PAP therapy parameter.

[00187] The indication of PAP can include an indication of at least one of inspiratory positive airway pressure (IPAP) associated with the PAP therapy or expiratory positive airway pressure (EPAP) associated with the PAP therapy. [00188] The indication of PAP can include an indication of at least one of fluid inhalation volume associated with the patient or fluid expiratory volume associated with the patient.

[00189] The PAP feedback control circuit can adjust pressure level in the cavity 110 toward a target cavity pressure, such as a target cavity pressure level based at least in part on the indication of PAP.

[00190] The microcontroller can be configured as an intraocular pressure (IOP) feedback control circuity, such as to generate an IOP feedback control circuit signal to adjust pressure level in the cavity 110 based at least in part on an indication of PAP. In an example, the IOP feedback control circuit can be configured to adjust the cavity pressure level in the cavity 112 toward a target IOP cavity pressure level.

[00191] The microcontroller can be configured as a blood flow (BF) feedback control circuit, such as to generate a BF feedback control circuit signal to adjust pressure level in the cavity 110 based at least in part on an indication of PAP. In an example, the BF feedback control circuit can be configured to adjust the cavity pressure level in the cavity 112 toward a target BF cavity pressure level. [00192] Ocular perfusion pressure (OPP) can be a based on or a function of blood flow, such as on at least one of blood flow in the eye or systemic blood flow in the patient. In an example, the BF feedback control circuit can include an OPP feedback control circuit, such as the OPP feedback circuit configured to adjust the cavity pressure level in the cavity 112 toward a target OPP cavity pressure level.

[00193] The microcontroller can be configured as a circadian rhythm (CR) feedback control circuit, such as to generate a CR feedback control circuit signal to adjust pressure level in the cavity 110 based at least in part on an indication of circadian rhythm. The indication of CR can include a CR parameter, such as sensed by a CR device. In an example, a CR parameter can include at least one of an indication of time, such as the local time referenced from a standard including Greenwich Mean Time (GMT), an indication of ambient lighting, such as level or intensity of visible light proximal to a patient, an indication of patient temperature, such as patient core temperature.

[00194] The PAP feedback control circuit can adjust pressure level in the cavity 110 toward a target cavity pressure, such as a target cavity pressure level based at least in part on the indication of PAP and an indication of patient body position.

[00195] The microcontroller can be configured as a patient body position (PBP) feedback control circuit, such as to generate a PBP feedback control circuit signal to adjust cavity pressure level in the cavity 110 based at least in part on an indication of patient body position. The indication of PBP can include a PBP parameter, such as sensed by a sensor 130 including a PBP sensor 131.

[00196] A PBP parameter can include at least one of an indication of patient body position, such as at least one of an indication of patient body position relative to a reference frame. In an example, the PBP parameter can include an indication of patient torso position, such as an indication of the patient torso with respect to a horizontal reference frame including the ground. In an example, the PBP parameter can include an indication of patient head position, such as an indication of the patient head with respect to a horizontal reference frame including the ground, or a local reference frame, such as the patient torso.

[00197] The control circuitry 140 can include or interface with a separate device, such as control circuitry 140 associated with an adjunct medical device. In an example, the control circuitry 140 can be configured to include or interface with a PAP device, such as PAP control circuitry associated with the PAP device.

[00198] Inclusion with a separate device can include control circuitry 140 that can be integrated with control circuitry of the adjunct medical device. In an example, adjunct medical device control circuitry can occupy at least one of the same circuit board or the same circuit board assembly as the control circuitry 140. In an example, the control circuitry 140 can be integrated with control circuitry of an adjunct medical device, such as PAP control circuitry associated with a PAP device. The control circuitry 140 can execute a feedback control loop to control a physiological parameter in a patient eye, such as based at least in part upon an indication of PAP received from the PAP control circuitry. [00199] Interface with a separate device can include control circuitry 140 that communicate with the separate device, such as to exchange data or cause one control circuitry to execute a given instruction set based upon data exchanged with the other control circuitry. In an example, the control circuitry 140 can be interface with control circuitry of an adjunct medical device, such as PAP control circuitry associated with a PAP device, where the control circuitry 140 can be located in communication with the apparatus 100 and the PAP control circuitry can be located in communication with the PAP device separate from the apparatus 100. The control circuitry 140 can execute a feedback control loop to control a physiological parameter in a patient eye, such as based at least in part upon an indication of PAP received from the PAP control circuitry located separate from the apparatus 100.

[00200] The microcontroller can be configured as a blood flow pressure feedback control circuit, such as to generate a blood flow pressure feedback control signal to adjust pressure level in the cavity 110 to vary ocular blood flow based on an indication of ocular blood flow. The indication of ocular blood flow can be sensed with the sensor 130, such as a blood flow sensor. The pressure level in the cavity can be adjusted toward a blood flow target cavity pressure level, such as the blood flow target cavity pressure level to adjust an indication of a physiological parameter.

[00201] The microcontroller can be configured as an applied force pressure feedback control circuit, such as to generate an applied force pressure feedback control signal to adjust pressure level in the cavity 110 to vary force applied to patient tissue, such as based on an indication of applied force between the cover 110 and patient tissue. The indication of applied force can be sensed with the sensor 130, such as a force sensor. The pressure level in the cavity can be adjusted toward an applied force target cavity pressure level, such as the applied force target cavity pressure level to adjust an indication of a physiological parameter.

[00202] The control circuitry 140 can include sweep circuitry, such as function-specific circuitry integrated into the control circuitry 140 or instructions implemented on the microcontroller. The sweep circuity can be configured to adjust non-ambient pressure applied to the cavity 112, such as by generating a control signal to adjust the pressure source 150 to apply a pressure level to the cavity 112, such as in a specified pattern. A pressure range can be defined by a first pressure level and a second pressure level, such as where the second pressure level is greater than the first pressure level.

[00203] The sweep circuitry can be configured to perform a sweep test, such as to sequentially vary non-ambient pressure level applied to the cavity 112 over a pressure range. Sequential variation of non-ambient pressure can include sequentially increasing non-ambient pressure level over the pressure range, such as from the first pressure level to the second pressure level. Sequential variation of non-ambient pressure can include sequentially decreasing non-ambient pressure level over the pressure range, such as from the second pressure level to the first pressure level. A patient, such as a patient associated with PAP therapy, can perform the sweep test and respond to each sweep pressure, such as by logging a response through the patient input sensor. Patient response to the sweep test can identify one or more target cavity pressures, such as a target cavity pressure that can adjust an indication of a physiological parameter in the patient. [00204] The sweep circuitry can be configured to define a target cavity pressure level, such as to adjust patient perception of an indication of a headache symptom to treat, inhibit, or prevent the headache symptom. The target cavity pressure level, such as the headache target cavity pressure value, can include a pressure level in the cavity 112, such as selected to adjust the patient perception associated with the headache symptom, such as to minimize patient perception of pain associated with the headache symptom.

[00205] The control circuitry 140 can be configured to receive an indication of PAP, such as an indication of PAP associated with the patient and adjust the cavity pressure level in the cavity 112, such as at least in part on the indication of PAP associated with the patient. The control circuitry 140 can adjust the cavity pressure level, such as by adjustment of the pressure source 150, such as a where pressure source operatively coupled to the cavity 112. In an example, the control circuitry 140 can be electrically coupled to the pressure source 150, such as to adjust operation of the pressure source 150 with the control circuitry 140 to adjust the level of cavity pressure in the cavity 112 based at least in part on the indication of PAP received by the control circuitry 140. The pressure source 150 can be operatively coupled to the cavity 112, such as with the conduit 117. [00206] The control circuitry 140 can be configured to interface with other control circuity, such as control circuitry associated with another device. In an example, the control circuitry 140 can be configured to include or interface with PAP control circuitry, such as PAP control circuitry associated with a device configured to deliver PAP to a patient including a PAP device. An indication of PAP can be received from the PAP control circuitry, such as at least in part from the PAP control circuitry. In an example, an indication of PAP from the PAP control circuitry can include at least one of an indication of IPAP, EPAP, inhalation volume, or exhalation volume.

[00207] The control circuit 140 can be configured to receive an indication of body position, such as an indication of body position associated with the patient and adjust the cavity pressure level in the cavity 112, such as at least in part on the indication of body position associated with the patient. The control circuitry 140 can adjust the cavity pressure level, such as by adjustment of the pressure source 150, such as a where pressure source can be operatively coupled to the cavity 112. In an example, the control circuitry 140 can be electrically coupled to the pressure source 150, such as to adjust operation of the pressure source 150 with the control circuitry 140 to adjust the level of cavity pressure in the cavity 112 based at least in part on the indication of body position received by the control circuitry 140. The pressure source 150 can be operatively coupled to the cavity 112, such as with the conduit 117.

[00208] The control circuitry 140 can be configured as a patient body position (PBP) feedback control circuit, such as to generate a PBP feedback control circuit signal to adjust cavity pressure level in the cavity 110 based at least in part on an indication of patient body position. In an example, the control circuitry 140 can be configured to adjust the cavity pressure level in the cavity 112 toward a target cavity pressure level.

[00209] The control circuitry 140 can be configured as an intraocular pressure (IOP) feedback control circuity, such as to generate an IOP feedback control circuit signal to adjust pressure level in the cavity 110 based at least in part on an indication of body position. In an example, the IOP feedback control circuit can be configured to adjust the cavity pressure level in the cavity 112 toward a target IOP cavity pressure level.

[00210] The control circuitry 140 can be configured as a blood flow (BF) feedback control circuit, such as to generate a BF feedback control circuit signal to adjust pressure level in the cavity 110 based at least in part on an indication of body position. In an example, the BF feedback control circuit can be configured to adjust the cavity pressure level in the cavity 112 toward a target BF cavity pressure level.

[00211] The control circuitry 140 can be configured as an intracranial pressure (ICP) control circuit. The ICP control circuit can control the application, such as selective application, of an external force, such as an external force applied to the patient and can be configured to adjust an indication of ICP in the patient. In an example, the ICP control circuit can be in communication with at least one of an apparatus 100, a sensor 130, a pressure source 150, a mask assembly 199, or an ICP force generator, such as at least one of an occlusive collar 310, a pressure collar 320, or a pressure vest 350.

[00212] The external force can be applied to the patient to adjust the indication of ICP, such as to increase or decrease ICP level relative to a baseline level of ICP. In an example, the baseline level of ICP can include the value of ICP present in the patient the absence of the application of the external force, such as the absence of the selective application of the external force.

[00213] A positive external force, such as an occlusive force applied to patient tissue in proximity to a venous vessel, can increase ICP level in the patient, such as by restricting the flow of venous fluid from the head to the torso to increase fluid pressure in the skull. In an example, the selective application of external force can increase the level of ICP in a range, such as a range of gauge pressure from about 0 mmHg gauge to about 25 mmHg gauge.

[00214] A negative external force, such as a dilatative force applied to patient tissue in proximity to a venous vessel, can decrease ICP level in the patient, such as by increasing the flow of venous fluid from the head to the torso to decrease fluid pressure in the skull. In an example, the selective application of external force can decrease the level of ICP in a range, such as a range of gauge pressure from about 0 mmHg gauge to about -25 mmHg gauge.

[00215] The ICP control circuit can receive an indication of a physiological parameter from a patient. The indication of a physiological parameter can include a measured indication of a physiological parameter from the patient, such as from a sensor 130. In an example, a measured indication of a physiological parameter can include in indication of ICP in the patient, such as from an ICP sensor, an indication of IOP in the patient eye, such as from an IOP sensor, or an indication of patient comfort, such as with a patient comfort user input interface in communication with the ICP control circuit. A patient comfort sensor can include an interface, such as an interface for a patient to record at least one of a perception or observation of treatment, comfort, or environment, such as while using an ICP force generator. In an example, data recorded with the patient comfort sensor can inform future use of the ICP force generator, such as to improve diagnosis or treatment of an eye condition.

[00216] In an example, the indication of a physiological parameter can include a specified indication of the physiological parameter, such as a value of the physiological parameter selected by a user. In an example, the ICP control circuit can include signal processor circuitry coupled to the sensor 130, such as to receive at least one of the measured indication or the specified indication during the application, including selective application, of an external force to the patient.

[00217] The ICP control circuit can be configured to adjust an indication of ICP in the patient, such as with respect to an indication of a physiological parameter from the patient. In an example, the ICP controller can receive a measured indication of an intraocular pressure (IOP) from the patient, such as with an IOP sensor, and control an external force applied to the patient, such as with an ICP force generator, to adjust ICP relative to the measured indication of IOP, such as toward a target TPD. In an example, the ICP controller can receive a specified value of IOP from a user, such as a value of average IOP over a period of time selected by the user, and control an external force applied to the patient, such as with an ICP force generator, to adjust ICP relative to the measured indication of IOP, such as toward a target TPD. In an example, the ICP controller can receive at least one of a measured indication of ocular blood flow from the patient or a specified ocular blood flow, and control an external force applied to the patient, such as with an ICP force generator, to adjust ICP relative to the indication of ocular blood flow. In an example, the ICP controller can receive at least one of a measured indication of retinal activity from the patient eye or a specified indication of retinal activity, and control an external force applied to the patient, such as with an ICP force generator, to adjust ICP relative to the indication of retina activity.

[00218] The ICP control circuit can be configured to control application of an external force to the patient, such as at least one of a positive or negative external force, to a target level. In an example, the target level can be based on the indication of a physiological parameter from the patient. The indication can include at least one of an indication of ICP in the patient, an indication of IOP in the patient eye, or an indication of patient comfort, such as related to application of the external force. In an example, the external force can be applied for a specified period of time, such as to equalize at least one of a TPD in the eye to a TPD target including a TPD target level or a translaminar pressure gradient (TPG) in the eye to a TPG target including a TPG target level. In an example, the TPG target level can include a TPD target level normalized by a dimension of the lamina cribrosa, such as a thickness of the lamina cribrosa. The period of time required to equalize at least one of a TPD to a TPD target or a TPG to a TPG target can differ depending, such as with variation in patient anatomy. In an example, the period of time can be measured in at least one of seconds, such as a range between about 0 and about 60 seconds, minutes, such as a range between about 1 minute and about 60 minutes, hours, such as a range between about 1 hour and about 24 hours, or days, such as a range between about 1 day and about 7 days.

[00219] The target level can include a set point level, such as at least one of a user-adjustable or a user-selectable set point level. The set point level can include a value, such as a desired value of an indication of a physiological parameter associated with the patient. In an example, the set point level can be selected, such as to bring an indication of IOP in the patient eye into an IOP level range or an indication of ICP in the patient into an ICP level range. The IOP level range can include a physiologically normal range of IOP, such as a range of about 10 mmHg to about 21 mmHg. The ICP level range can include a physiologically normal range of ICP, such as a range of about 8 mmHg to about 20 mmHg.

[00220] An IOP-ICP system can be configured to control IOP in a patient eye and ICP in patient, such as to independently control at least one of IOP or ICP or to concurrently control IOP and ICP. The system can include an apparatus to adjust IOP in the patient eye, such as at least one of the apparatus 100 or the mask assembly 199, an apparatus to adjust ICP in the patient, such as at least one of an occlusion collar 310, a pressure collar 320, or a pressure vest 350, and an ICP control circuit.

[00221] The ICP control circuit can be configured to control or adjust one or more physiological parameters, such as one or more physiological parameters associated with the patient. In an example, the ICP control circuit can control or adjust at least one of an IOP level in a patient eye or an ICP in the patient, such as where control or adjustment of ICP can occur independently of or dependently on IOP adjustment and control or adjustment of IOP can occur independently of or dependently on ICP adjustment.

[00222] The IOP-ICP system can include one or more example embodiments. FIG. 22 shows an apparatus 100 configured to adjust IOP level in a patient and an occlusion collar 310 configured to adjust ICP level in the patient, such as where the ICP control circuit can adjust at least one of the IOP level or the ICP level. In an example, FIG. 23 shows an apparatus 100 configured to adjust IOP level in a patient and a pressure collar 320 configured to adjust ICP level in the patient, such as where the ICP control circuit can adjust at least one of the IOP level or the ICP level. In an example, FIG. 24 shows a mask assembly 199 configured to adjust IOP level in a patient while delivering positive airway pressure (PAP) to the patient and an occlusion collar 310 configured to adjust ICP level in the patient, such as where the ICP control circuit can adjust at least one of the IOP level or the ICP level. FIG. 25 shows an example of a mask assembly 199 configured to adjust IOP level in a patient while delivering positive airway pressure (PAP) to the patient and an apparatus 320 configured to adjust ICP level in the patient, such as where the ICP control circuit can adjust at least one of the IOP level or the ICP level. FIG. 26 shows an example of an apparatus 100 configured to adjust IOP level in a patient and an apparatus 350 configured to adjust ICP level in the patient, such as where the ICP control circuit can adjust at least one of the IOP level or the ICP level. FIG. 27 shows an example of a mask assembly 199 configured to adjust IOP level in a patient while delivering positive airway pressure (PAP) to the patient and an apparatus 350 configured to adjust ICP level in the patient, such as where the ICP control circuit can adjust at least one of the IOP level or the ICP level.

[00223] The ICP control circuit, such as in communication with the IOP-ICP system, can be configured to control or adjust fluid pressure in an apparatus 100, such as in a cavity 112 located over an eye of the patient to adjust IOP in the patient eye, and control the application of an external force, such as the selective application of an external force applied to the patient and configured to adjust an indication of ICP in the patient. In an example, the ICP control circuit can receive a target IOP value for the patient eye and apply pressure to the cavity 112, such as pressure configured to adjust IOP in the patient eye toward the target IOP value. The ICP control circuit can also control an external force applied to the patient, such as with an ICP force generator, to adjust ICP with respect to the target IOP value, such as toward a target TPD. [00224] The ICP control circuit can control to a target value, such as based at on a set point level including a set point level based at least in part on an indication of a physiological parameter associated with the patient eye. In an example, a received IOP value, such as an IOP value measured from a patient eye or a user-selected IOP value, can be received by the ICP control circuit. A target IOP value, such as a set point IOP value including a user-selected set point IOP value based on inspection of the received IOP value, can be received by the ICP control circuit. The ICP control circuit can adjust IOP level in the patient eye toward the set point IOP target value, such as to adjust patient IOP level into a IOP range including a physiologically normal IOP range from about 10 mmHg to about 21 mmHg. A target TPD value, such as a TPD value to normalize TPD level across the lamina cribrosa in the patient eye, can be received by the ICP control circuit. The ICP control circuit can adjust ICP level in the patient, such as to adjust ICP level toward the target TPD value, to at least one of diagnose, inhibit, or treat an eye condition in the patient eye.

[00225] In an example, a received ICP value, such as an ICP value measured from a patient or a user-selected ICP value, can be received by the ICP control circuit. A target ICP value, such as a set point ICP value including a user- selected set point ICP value based on inspection of the received ICP value, can be received by the ICP control circuit. The ICP control circuit can adjust ICP level in the patient eye toward the set point ICP target value, such as to adjust patient ICP level into an ICP range including a physiologically normal ICP range from about 8 mmHg to about 20 mmHg. A target TPD value, such as a TPD value to normalize TPD level across the lamina cribrosa in the patient eye, can be received by the ICP control circuit. The ICP control circuit can adjust IOP level in the patient, such as to adjust IOP level toward the target TPD value, to at least one of diagnose, inhibit, or treat an eye condition in the patient eye.

[00226] Ocular perfusion pressure (OPP) can be a based on an indication of blood flow, such as on at least one of blood flow in the eye or systemic blood flow in the patient. In an example, the BF feedback control circuit can include an OPP feedback control circuit, such as the OPP feedback circuit configured to adjust the cavity pressure level in the cavity 112 toward a target OPP cavity pressure level. In an example, the OPP feedback circuit can be configured to adjust pressure level in the cavity 110 based at least in part on an indication of body position.

[00227] The microcontroller can be configured as a patient body position (PBP) feedback control circuit, such as to generate a PBP feedback control circuit signal to adjust cavity pressure level in the cavity 110 based at least in part on an indication of patient body position. The indication of PBP can include a PBP parameter, such as sensed by a sensor 130 including a PBP sensor 131.

[00228] A PBP parameter can include at least one of an indication of patient body position, such as at least one of an indication of patient body position relative to a reference frame. In an example, the PBP parameter can include an indication of patient torso position, such as an indication of the patient torso with respect to a horizontal reference frame including the ground. In an example, the PBP parameter can include an indication of patient head position, such as an indication of the patient head with respect to a horizontal reference frame including the ground, or a local reference frame, such as the patient torso.

[00229] The PBP parameter can be used to control the cavity pressure level, such as cavity pressure level applied to the cavity 112. The cavity pressure level can be adjusted, such as toward a target cavity pressure level. The target cavity pressure level can be based, at least in part, on an indication of body position. In an example, the cavity 112 can include the left cavity 112A and the target cavity pressure level can include a target left IOP cavity pressure level, such as based on an indication of body position. In an example, the cavity 112 can include the right cavity 112B and the target cavity pressure level can include a target right IOP cavity pressure level, such as based on an indication of body position. [00230] In an example, the cavity 112 can include the left cavity 112A and the target cavity pressure level can include a target left blood flow cavity pressure level, such as based on an indication of body position. In an example, the cavity 112 can include the right cavity 112B and the target cavity pressure level can include a target right blood flow cavity pressure level, such as based on an indication of body position.

[00231] In an example, the cavity 112 can include the left cavity 112A and the target cavity pressure level can include a target left OPP cavity pressure level, such as based on an indication of body position. In an example, the cavity 112 can include the right cavity 112B and the target cavity pressure level can include a target right OPP cavity pressure level, such as based on an indication of body position.

[00232] The apparatus 100 can include an assembly to adjust a physiological parameter in a patient eye. In an example, the apparatus 100 can include an eye cover 110, such as an eye cover 110 configured to retain a non-ambient pressure level over the patient eye to adjust an indication of the physiological parameter in the patient eye, and a sensor 130, such as a body position sensor, located in fixed proximity to the patient eye and configured to sense an indication of patient position, such as to adjust the non-ambient pressure level over the patient eye based at least in part on the an indication of the body position.

[00233] The sensor 130 can include a patient position sensor, such as to sense an indication of patient position. The indication of patient position can include the indication of patient position with respect to a horizontal plane, such as a plane tangent to the surface of the Earth. The indication of patient position with respect to a horizontal plane can include at least one of a supine position, such as a patient parallel to the horizontal plane and facing away from the Earth, a prone position, such as a patient parallel to the horizontal plane and facing toward the Earth, a left lateral decubitus position, or a right lateral decubitus position. [00234] The apparatus 100 can operate to identify or define a target cavity pressure level, such as a target cavity pressure level to adjust an indication of a physiological parameter. The apparatus 100 can include a sensor 130, such as the patient response sensor, configured to receive patient input, such as an indication of a physiological parameter as the non-ambient pressure in the cavity 112 is varied in the pressure range. In an example, the target cavity pressure value can be defined as the non-ambient pressure level applied to the cavity 112 that can minimize the indication of the physiological parameter.

[00235] Processing the received indication of pressure can include calculating an indication, such as calculating an indication of the difference between the indication of cavity pressure level and an indication of user preference, including a cavity pressure setpoint level received from the communication interface to form an indication of a cavity pressure difference value. Processing the received indication can include generating a control signal based on the indication of cavity pressure difference value with a proportional-integral-derivative (PID) control algorithm running on the microcontroller to adjust the pressure source 150. Generating a control signal can include generating a control signal to minimize the difference between the received indication of pressure level and the cavity pressure setpoint level.

[00236] The microcontroller can be configured as a concentration feedback control circuit, such as to generate a regulator control signal to adjust a chemical constituent level in the cavity 112.

[00237] In an example, the regulator control signal can be based on an indication of a chemical constituent associated with the working fluid, such as an indication of nitric oxide (NO) concentration, to achieve a target NO concentration level in the working fluid. The concentration feedback control circuit can receive an indication of NO concentration level in the working fluid, such as an indication of NO level sensed by the senor 130 including a concentration sensor configured to sense NO. The concentration feedback control circuit can process the received indication of NO level to form a control signal, such as a control signal to adjust the regulator 120 to achieve the target NO concentration level in the cavity 112.

[00238] Processing the received indication of NO concentration can include calculating the difference between the indication of NO concentration and an indication of user preference, including a NO setpoint level received from the communication interface, to form a NO difference value. Processing the received indication can include generating a control signal based on the NO difference value. Processing the received indication can include generating a control signal based on the NO difference value with a proportional-integral- derivative (PID) control algorithm running on the microcontroller to adjust the regulator 120. Generating a control signal can include generating a control signal to minimize the difference between the received indication of NO concentration and the NO setpoint level.

[00239] The control circuitry 140 can include a power source 152, such as to supply electrical energy to the apparatus 100. In an example, the power source 152 can include a battery, such as a lithium ion battery, and a transformer, such as to receive power from a wall outlet for use in the apparatus 100 at a specified voltage and current. The control circuitry 140 can include a heating element, such as a heating element in communication with the therapeutic fluid including a heating element located on a surface of or in proximity to the cover 110 including an inner surface 188 of the cover 110, or the fluid regulator 120, to increase the temperature of the therapeutic fluid.

[00240] The pressure source 150 can generate a volumetric flow of working fluid in the apparatus 100, such as to move working fluid from the pressure source 150 to the cavity 112 or to move working fluid from the cavity 112 to at least one of the pressure source 150 or to the surrounding environment. The pressure source 150 can be configured to apply non-ambient pressure to the cavity 112, such as to adjust an indication of fluid pressure including an indication of pressure level in the cavity 112, from a first pressure level to a second pressure level different from the first pressure level. A non-ambient pressure can include a pressure in the cavity 112 different from an ambient pressure, such as an ambient pressure surrounding the apparatus 100. In an example, a non-ambient pressure can include at least one of a positive non ambient pressure, such as where the cavity pressure can be greater than the surrounding atmosphere, or a negative non-ambient pressure, such as where the cavity pressure can be less than the surrounding atmosphere.

[00241] The pressure source 150 can include a pump, such as a pump that can generate at least one of a positive gauge pressure or a negative gauge pressure. The pressure source 150 can include an electrically-powered pressure source, such as a pump including a displacement pump or a centrifugal pump. For example, the pressure source 150 can include a diaphragm pump, such as a diaphragm vacuum pump. The pressure source 150 can include a manually- powered pressure source, such as a hand pump including a bellows-style pump. In an example, the pressure source 150 can be integrated into a component of the apparatus 100, such as the cover 110.

[00242] The pressure source 150 can be configured to generate a gauge pressure, such as one or more gauge pressures including at least one of a first gauge pressure and a second gauge pressure different than the first gauge pressure. The pressure source 150 can include a first pressure source configured to deliver the first gauge pressure and a second pressure source configured to deliver the second gauge pressure. The first pressure source can include an eye cavity pressure source, such as to deliver non-ambient pressure to the cavity 110, and the second pressure source can include a Pressure/flow generator, such as to deliver non-ambient pressure to the patient airway.

[00243] The non-ambient pressure level delivered by the eye cavity pressure source can be related, at least in part, to an indication of PAP associated with the patient, such as a non-ambient pressure level delivered to the patient by the Pressure/flow generator. In an example, an indication of PAP can include at least one of the type of PAP device used, such as CPAP, Bi-PAP, or other PAP device, PAP energization (e.g., PAP on or off), or an indication of PAP use, such as at least one of use frequency, use duration, or other historic or current PAP therapy parameter.

[00244] The pressure/flow generator can be configured to generate a positive gauge pressure level for application to the airway of a patient, such as to maintain a patent airway to treat obstructive sleep apnea, and the eye cavity pressure source can be configured to generate a negative gauge pressure level, such as a negative gauge pressure to adjust an indication of a physiological parameter associated with the patient eye. In an example, the eye cavity pressure source can include a pressure source separate from the pressure/flow generator, such as the pressure/flow generator can be located in a first generator housing shroud and the eye cavity pressure source can be located in a second generator housing shroud separate from the first generator housing shroud. [00245] Components of the apparatus 100 and the PAP device can be integrated, such as the apparatus 100 and the PAP device can share one or more components. Integration of the apparatus 100 and the PAP device can improve a therapeutic effect for the patient, such as through coordinated operation of the apparatus 100 and the PAP device or to create a more ergonomically-efficient system.

[00246] In an example, the pressure/flow generator and the eye cavity pressure source can be integrated, such as the pressure/flow generator and the eye cavity pressure source can share one or more common components. For example, the eye cavity pressure source can be in proximity to the pressure/flow generator, such as the eye cavity pressure source and the pressure/flow generator can both be located in a single generator housing shroud.

[00247] In an example, control circuity 140 and the PAP device controller can be integrated, such as the control circuitry 140 and the PAP device controller can share one or more common components. For example, the control circuitry 140 can be configured as a system controller, such as to directly control both the pressure/flow generator of the PAP device, such as with a portion of the control circuitry 140 including a pressure/flow generator control circuitry portion, and the eye cavity pressure source, such as with a portion of the control circuitry 140 including an eye cavity pressure source control circuitry portion.

[00248] In an example, the control circuitry 140 can be configured as a system regulator, such as to coordinate operation of the apparatus 100 and the PAP device. For example, the control circuitry 140 can receive an indication from at least one of the apparatus 100 or the PAP device, process the received indication, and generate a signal for transmission to at least one of the apparatus 100 or the PAP device.

[00249] As a system regulator, the control circuitry 140 can be in electrical communication with the pressure/flow generator controller, such as to coordinate operation of the apparatus 100 with the PAP device. In an example, control circuitry 140 can be in electrical communication with both the pressure/flow generator controller and the eye cavity pressure source 150, such as to form an integrated control system to coordinate operation of the apparatus 100 and the PAP device. The control circuitry 140 can be configured to operate in a master- slave mode, such as operational parameters associated with at least one of the pressure/flow generator or the eye cavity pressure source can be used to control operation of the other component.

[00250] In an example, the “master” pressure/flow generator controller can influence operation of the “slave” eye cavity pressure source controller, such as by passing an indication of PAP from the pressure/flow generator controller to the to the eye pressure cavity source controller. For example, in the case where the PAP device can be designated the “master” device and the apparatus 100 can be designated the “slave” device, the control circuitry 140 can receive an indication of PAP from the pressure/flow generator controller, such as an indication of inspiratory positive airway pressure (IPAP) applied to a patient airway, process the indication of IPAP, such as with a microcontroller included with the control circuitry 140, and generate an eye cavity pressure source control signal, such as to cause the eye cavity pressure source 150 to generate an eye cavity pressure level based at least in part on the indication of IPAP.

[00251] In an example, the “master” eye cavity pressure source controller can influence operation of the “slave” pressure/flow generator controller, such as by passing a pressure/flow generator control signal to the pressure/flow generator controller. For example, in the case where the apparatus 100 can be designated the “master” device and the PAP device can be designated the “slave” device, the control circuitry 140 can receive an indication of a physiological parameter, such as an indication of IOP in the patient eye sensed by an IOP sensor, process the indication of IOP, such as with a microcontroller included with the control circuitry 140, and generate an pressure/flow generator control signal, such as to cause the pressure/flow generator to generate a PAP level for delivery to the patient based at least in part on the indication of IOP.

[00252] In an example, the pressure source 150 and the pressure/flow generator can be integrated, such as the function of the pressure source 150 and the pressure/flow generator can be achieved by the pressure/flow generator. The pressure/flow generator can generate a pressure differential, such as at least one of a positive gauge pressure or a negative gauge pressure, for delivery to a patient, such as a patient airway to treat a sleep disorder. A positive gauge pressure can cause a positive fluid flow, such as from an outlet of the pressure/flow generator to the patient airway through a PAP tube. In an example, a pressure inverter 180 can generate a negative gauge pressure, such as a negative gauge pressure configured to reduce pressure level in an adjacent enclosure, when placed in contact with a flow of fluid, such as the positive fluid flow in the PAP tube.

[00253] FIG. 13 shows an example of a pressure inverter 180, such as a tubular device configured to create a negative gauge pressure based on fluid flow through the pressure inverter 180. The pressure inverter 180 can include a tube with a wall inner surface 181, a wall outer surface 182, and a transition portion 193 located between a flow inlet port 184 and a flow outlet port 185. A pressure inverter centerline 187 can be defined as a line passing through a centroid of a cross-sectional area of the transition portion 193, such as each cross-sectional area perpendicular to the wall inner surface 181. The shape of the cross- sectional area can include any planar geometrical shape, such as at least one of a circular, triangular, rectangular, or polygonal-sided shape.

[00254] The pressure inverter 180 can include an inverter pressure port 186, such as one or more pressure ports 186, located on a surface of the transition portion 193, such as the exterior surface of the transition surface. The inverter pressure port 186 can include a hole, such as an opening in the tube wall extending from the wall inner surface 181 to the wall outer surface 182. The inverter pressure port 186 can include an interface connector, such as the interface connector configured to connect a hose to the pressure inverter 180.

The inverter pressure port 186 can include a valve, such as a flapper valve, to prevent a loss of seal pressure at the vacuum gasket 189, such as during reversals in airflow direction at the transition portion 193.

[00255] The transition portion 193 can include a restriction, such as a change in the cross-sectional area of the transition portion 193. The restriction can be defined by a reduction in the cross-sectional area of the transition portion 193, such as a contiguous reduction of cross-sectional area from the inlet 184 to approximately the midway point between the inlet 184 and the outlet 185, followed by an increase in the cross-sectional area of the transition portion 193, such as a contiguous increase of cross-sectional area from approximately the midway point to the outlet 185. An example of a restriction with a generally circular cross-section can be seen in FIG. 13.

[00256] The restriction can be configured to apply Bernoulli’s principle to fluid flow through the transition portion 193, so that fluid passing through the restriction can cause fluid velocity to increase while reducing static pressure along the wall inner surface 181 of the transition portion 193. In an example, the inverter pressure port 186 can be located in proximity to the restriction, such as fluid flow in the transition portion 193 can increase fluid flow velocity and reduce static pressure at the wall inner surface 181 to create region of reduced pressure (or a vacuum) at the inverter pressure port 186.

[00257] FIG. 14 shows an example of a mask assembly 199 including an eye cover and a nasal face mask 113 with a transition portion 193. The transition portion 193 can be located in line with a PAP tube, such as to receive fluid flow from the pressure/flow generator at the flow inlet port 184 and direct flow through the transition portion 193 to the flow outlet port 185. The inverter pressure port 186 can be located on the transition portion 193, such as at the restriction in the transition portion 193. A vacuum, such as a region of static pressure at the wall inner surface 181 lower than the pressure of fluid flowing past the inverter pressure port 186, can be generated at the inverter pressure port 186, such as due to fluid flow through the restriction in the transition portion 193.

[00258] The mask assembly 199 of FIG. 14 can include a flow enclosure tube 197, such as a tube with a lumen that can place the cavity 112 of the enclosure 110 in fluidic communication with the inverter pressure port 186. The mask assembly 199 can include a left flow enclosure tube 197A connected to a left inverter pressure port 186A and a right flow enclosure tube 197B connected to a right inverter port 186B. In an example, fluid flow through the transition portion 193 can create a vacuum at the inverter pressure port 186, such as to draw fluid from the cavity 112, such as to adjust the cavity pressure level in the cavity 112 to create a negative gauge pressure in the cavity 112. In an example, the negative gauge pressure can be adjusted toward a target cavity pressure level in the cavity 112, such as by adjusting the cavity pressure level toward the target cavity pressure level by utilizing fluid flow in the transition portion 193 to create a vacuum at the inverter pressure port 186 to draw fluid from the cavity 112 resulting in the adjustment of cavity pressure level in the cavity 112. The target cavity pressure level can include a pressure level in the cavity 112, such as to reduce IOP in the patient eye toward a target translaminar pressure difference (TPD) across a lamina cribrosa of the patient eye. A target TPD can include a value, such as a target TPD value specified by a range of values. In an example, a target TPD can include a value in a range of about -10 mmHg to about 10 mmHg. A target TPD can include a range, such as at least one of a positive TPD target range or a negative TPD target range. In an example, a positive TPD target range can include the situation where IOP is greater than ICP, such as where TPD falls in a range of about 0 mmHg to about 5 mmHg or about 5 mmHg to about 10 mmHg. In an example, a negative TPD target range can include the situation where ICP is greater than IOP, such as where TPD falls in a range of about 0 mmHg to about -5 mmHg or about -5 mmHg to about -10 mmHg.

[00259] The flow enclosure tube 197 can include a flow valve 198, such as a valve to regulate the volumetric rate of fluid drawn from the cavity 112 by the vacuum at the inverter pressure port 186, to control the rate of pressure adjustment in the cavity 112. The flow valve 198 can include a left flow valve 198 A and a right flow valve 198B. In an example, a cavity pressure level in the cavity 112, such as the left cavity 112A and the right cavity 112B, can be adjusted toward a target cavity pressure level, such as a left target cavity pressure level and a right target cavity pressure level, by utilizing fluid flow in the transition portion 193 to create a vacuum at the inverter pressure port 186. The volumetric rate of fluid drawn from the cavity 112 can be adjusted by the flow valve 198, such as the left flow valve 198 A associated with the left cavity 112A and the right flow valve 198B associated with the right cavity 112B, toward the target cavity pressure level. In an example, the flow valve 198 can include an adjustable valve, such as a solenoid valve in electrical communication with the control circuitry 140, to adjust the rate of pressure adjustment in the cavity 112.

[00260] The cavity 112 can include a negative pressure cavity check valve 183, such as a valve 183 with a cracking pressure. The cracking pressure can be selected, such as to control the negative gauge pressure level in the cavity 112.

In an example, the cracking pressure can be selected, such as to limit the maximum negative gauge pressure level in the cavity 112. For example, the cracking pressure can be selected to limit maximum negative gauge pressure level to a target level, such as at least one of a target TPD level or toward a target TPD level.

[00261] FIG. 15 shows an example of a strapless nasal face mask 205. The mask 205 can include a nasal face mask 113 with a vacuum gasket 189. The vacuum gasket 189 can be located between the nasal face mask 113 and the patient, such as in communication with the fluid flow in the transition portion 193 through the flow enclosure tube 197. The vacuum gasket 189 can be configured to adhere to the patient during the use of the PAP device. In an example, vacuum at the inverter pressure port 186 created by fluid flow in the transition portion 193 can be used to evacuate the vacuum gasket 189, such as to create a region of negative gauge pressure in the vacuum gasket 189 to draw the nasal face mask 113 to the patient. In an example, the vacuum gasket 189 can be used to couple the nasal face mask 113 to or retain the nasal face mask 113 against the patient, such as to eliminate the need for retaining devices including head straps, such as to improve the user experience associated with the PAP device.

[00262 j Fluid flow through the transition portion 193, such as fluid flow from the pressure source 150 to the nasal face mask 113, can generate a negative gauge pressure in the flow enclosure tube 197, such as a negative gauge pressure level proportional to the fluid flow velocity through the transition portion 193 to retain the nasal face mask 113 against the patient. As fluid flow velocity through the transition portion 193 changes, negative gauge pressure level in the vacuum seal 189 can change, such as proportionally with respect to fluid flow velocity through the transition portion 193. A change in negative gauge pressure in the vacuum seal 189, such as a decrease in negative gauge pressure, can cause the nasal face mask 113 to decouple from the patient. A gauge pressure level in the vacuum seal 189 can be regulated or maintained, such as with a valve.

[00263] The mask 205 can include a valve 207, such as to maintain a negative gauge pressure level in the vacuum seal 189 independent of fluid flow in the transition portion 193. The valve 207 can be located on the face mask 205, such as between the inverter pressure port 186 and the vacuum gasket 189. The valve 207 can include an active valve, such as a solenoid valve to regulate the difference in pressure between the port 186 and the vacuum gasket 189. The valve 207 can include a passive valve, such as a negative pressure cavity check valve. The negative pressure cavity check valve can include a flapper valve configured maintain a negative gauge pressure in the vacuum gasket 189.

[00264] The pressure inverter 180 can be incorporated into fluid flow, such as created by the pressure/flow generator and can be related to positive gauge pressure level applied to the patient airway. In an example, the eye cavity pressure source can include an aspirator pump, such as a device that uses the venturi effect to generate a negative gauge pressure including a venturi pump or an ejector jet pump. For example, the Pressure/flow generator can generate fluid flow to create a positive gauge pressure for delivery to the patient airway and for delivery to the aspirator pump. As the fluid with positive gauge pressure flow through the aspirator pump, negative gauge pressure can be generated by the pump, such as a negative gauge pressure level in the cavity 112 that can be related to the positive gauge pressure level applied to the aspirator pump.

[00265] In an example, the eye cavity pressure source can be configured to apply a cavity pressure level to the cavity 112 and the Pressure/flow generator can be configured to coordinate operation with the eye cavity pressure source, such as to apply a PAP level to the patient based at least in part on the eye cavity pressure level applied to the cavity 112.

[00266] The control circuitry 140 can be operatively coupled to the first pressure source and the second pressure source, such as to coordinate operation of at least one of the first pressure source and the second pressure source based on a parameter generated by the first pressure source or coordinate operation of at least one of the first pressure source and the second pressure source based on a parameter generated by the second pressure source.

[00267] The pressure source 150 can include a source of pressure, such as a pressurized gas cylinder or a source of pressurized fluid separate from the apparatus 100 that can be used to adjust working fluid pressure in the cavity 112. The pressure source 150 can include a source of pressure used in combination with a supplementary device to adjust pressure in the cavity. In an example, the pressure source 150 can include a venturi -type pump, such as a venturi jet pump, in communication with the source of pressure to adjust fluid pressure in the cavity 112.

[00268] The pressure source 150 can be characterized by physical characteristics, such as a relationship between physical characteristics. A useful measure for comparing the performance of several sources of flow includes a volume-pressure characteristic, such as the relationship between the volume of working fluid flow from a source of flow and the pressure, such as static pressure, created due to the fluid flow. In an example, the pressure source 150 can be characterized by a volume-pressure characteristic, such as a p-Q chart. [00269] The pressure source 150 can generate a pressure in the cavity 112, such as to adjust pressure in the cavity 112 to move towards or achieve a target cavity pressure in the cavity 112. The target cavity pressure can include the cavity pressure to adjust an indication of a physiological parameter.

[00270] The pressure source 150 can be operatively coupled to a second pressure source, such as a Pressure/flow generator or a pressure source associated with an adjunct device.

[00271] The adjunct device 160 can apply energy to stimulate patient tissue, such as in combination with the apparatus 100, such as to affect an indication of a physiological parameter. The adjunct device 160 can include a neuromodulation device, such as an electrical stimulation neuromodulation device.

[00272] An electrical neuromodulation stimulation device can include a transcutaneous electrical nerve stimulation (TENS) device. A TENS device can include a power supply, such as to generate electrical stimulation energy, and an electrode, such as to transmit energy from the power supply to a patient.

[00273] The TENS device can include a facial nerve stimulator, such as a device to stimulate a supraorbital (or trigeminal) nerve. The facial nerve stimulator can include a device from CEFALY-Technology (Liege, Belgium) offered for sale under at least one of the tradenames Cefaly ACUTE, Cefaly DUAL, or Cefaly PREVENT.

[00274] The TENS device can include a cranial nerve stimulator, such as a device to stimulate at least one of a vagus nerve or a nerve originating at the trigeminal nerve nuclei. The vagus nerve stimulator can include a device from electroCore (Basking Ridge, New Jersey) offered for sale under at least one of the trademarks GAMMACORE®, GAMMACORE SAPPHIRE®, or GAMMACORE VET®.

[00275] The TENS device can include a peripheral nerve stimulator, such as a device to stimulate at least one of a peripheral or a non-cranial nerve in the patient. The peripheral nerve stimulator can include a device from Theranica Bio-Electronics Ltd. (Netanya, Israel) offered for sale under the trademark NERIVIO MIGRA®.

[00276] An electrical neuromodulation stimulation device can include an implantable electrode device. An implantable electrode device can include a power supply, such as to generate electrical stimulation energy, and an implantable electrode, such as to transmit energy from the power supply to a patient.

[00277] The implantable electrode device can include an occipital nerve stimulator, such as a device to stimulate an occipital nerve in the patient. The implantable electrode device can include a spinal cord stimulator, such as a device to stimulate a spinal nerve including a dorsal column in the patient. The implantable electrode device can include a sphenopalatine ganglion stimulator, such as a device to stimulate the sphenopalatine ganglion. The implantable electrode device can include a deep brain stimulator, such as a device to stimulate the ventral tegmental area.

[00278] An electrical neuromodulation stimulation device can include a magnetic stimulation device. A magnetic stimulation device can include a power supply, such as to generate electrical stimulation energy, and a coil, such as to transmit energy from the power supply to a patient in the form of a magnetic field.

[00279] The magnetic stimulation device can include a transcranial magnetic stimulator (TMS) including a repetitive transcranial magnetic stimulator (rTMS), such as a device to stimulate at least a portion of the patient brain to affect a patient headache symptom. The magnetic stimulation device can include a single-pulse TMS (sTMS), such as a device to stimulate at least a portion of the patient brain to affect a patient headache symptom with a single pulse of magnetic energy. The sTMS can include a device from eNeura (Baltimore, MD) offered for sale under the trademark sTMS mini™

[00280] The adjunct device 160 can include a pharmacological (or pharma) drug delivery device, such as for localized or systemic delivery of a drug to a patient to enhance the effect of therapies described elsewhere in this application including stimulation of patient tissue with the apparatus 100.

[00281] The pharma drug delivery device can include a timer or other notification device, such as to alert or remind a patient to administer a medication orally. In an example, an acute change in a physiological parameter can be treated with the apparatus 100 adjusting applied non-ambient cavity pressure toward a target cavity pressure value and administration of a fast-acting drug administered to adjust the physiological parameter.

[00282] The target cavity pressure can include the cavity pressure to affect a treatment of the patient eye, such as a cavity pressure prescribed by a medical professional to treat, inhibit, or prevent an eye condition. Pressure in the cavity 112 can be adjusted, such as toward a target cavity pressure level, by adjustment of the pressure source 150, such as with a feedback control loop running on control circuitry 140. Treatment of the patient eye can be affected by the pressure source 150, such as by adjusting the pressure source to achieve a target cavity pressure in the cavity 112 to affect a desired indication of IOP level in the patient eye.

[00283] The target cavity pressure level can include a target cavity pressure to affect an indication of a physiological parameter of the patient eye. An indication of a physiological parameter can include an indication of IOP level in the patient eye, such as sensed by a sensor 130 configured to sense the indication of IOP in the eye. The target cavity pressure can include a target IOP cavity pressure level, such as a cavity pressure level that can be applied to the eye to achieve a selected IOP level in the patient eye, such as an IOP level selected to treat an eye condition.

[00284] An indication of a physiological parameter can include an indication of ocular blood flow in the patient eye, such as sensed by a sensor 130 configured to sense the indication of blood flow in the eye. The target cavity pressure can include a target blood flow cavity pressure level, such as a cavity pressure level that can be applied to the eye to achieve a selected blood flow level in the patient eye, such as a blood flow level selected to treat an eye condition.

[00285] An indication of ocular blood flow can include an indication of ocular perfusion pressure (OPP). OPP can be characterized as a relationship between blood pressure (BP), such as sensed by a sensor 130 configured to sense systemic blood pressure in the patient, and the IOP in the patient eye. An indication of OPP, such as OPP level, can include the difference between an indication of BP, such as BP level in the patient, and the indication of IOP, such as IOP level in the patient eye. In an example, OPP level can include a mean OPP level (MOPP) defined as MOPP = 2/3 * (MAP - IOP), such as where MAP = mean arterial pressure = DBP + 1/3 * (SBP - DBP), where SBP is systolic blood pressure and DBP is diastolic blood pressure. The target cavity pressure can include a target OPP cavity pressure level, such as a cavity pressure level that can be applied to the eye to achieve a selected OPP level in the patient eye, such as an OPP level selected to treat an eye condition.

[00286] The adjunct device 160 can include a positive airway pressure (PAP) device. In an example, a PAP device can include at least one of a continuous positive airway pressure (CPAP) device, a bi-level positive airway pressure (Bi- PAP) device, or any other device that can delivery PAP to a patient, such as an airway of the patient.

[00287] FIG. 7 shows an example of an apparatus 1100 that can control an eye environment over a patient eye, such as at least one of a left eye environment over the left patient eye or a right eye environment over the right patient eye. Controlling an eye environment can include at least one of establishing, adjusting, or maintaining an indication of the eye environment over the patient eye, such as an indication of working fluid cavity pressure in the cavity 112. In an example, control of the left eye environment can be independent of the right eye environment and control of the right eye environment can be independent of the left eye environment.

[00288] The apparatus 1100 can include a left system 1102 with a left cover 110A sized and shaped to fit over a left eye of a patient to define a left cavity 112A between the left cover 110A and an anterior surface of the left eye. The apparatus 1100 can include a right system 1104 with a right cover 110B sized and shaped to fit over the right eye of the patient to define a right cavity 112B between the right cover 110B and an anterior surface of the right eye. The apparatus 1100 can include a bridge 1106, such as to locate the left system 1102 with respect to the right system 1104. In an example, the left system 1102 can include at least one of the apparatus 100 and the right system 1104 can include at least one of the apparatus 100.

[00289] The apparatus 1100 can include system control circuitry 1140 to facilitate, coordinate, and control operation of the apparatus 1100. The system control circuitry 1140 can be configured to receive and process an indication of the eye environment, such as at least one of an indication of the left eye environment, an indication of the right eye environment, or an indication of a relationship between the indication of the left eye environment and the indication of the right eye environment.

[00290] The system control circuitry 1140 can include at least one of left control circuitry 140 A, such as left control circuitry 140A to facilitate, coordinate, and control operation of the left system 1102, or right control circuitry 140B, such as right control circuitry 140B to facilitate, coordinate, and control operation of the right system 1102. In an example, the left control circuitry 140 A can be configured to control operation of the left system 1102 independently of the right system 1104 and the right system 1104 can be configured to control operation of the right system 1104 independently of the left system 1102. In an example, the left control circuitry 140A can be capable of receiving and processing at least one of the indication of the left eye environment or the indication of the relationship between the left eye environment and the right eye environment. In an example, the right control circuitry 140B can be capable of receiving and processing at least one of the indication of the right eye environment or the indication of the relationship between the left eye environment and the right eye environment.

[00291] The system control circuitry 1140 can include pressure source circuitry, such as pressure source circuitry configured to adjust operation of the pressure source based on at least one of the indication of the left eye environment, the indication of the right eye environment, or the indication of a relationship between the indication of the left eye environment and the right eye environment. In an example, the pressure source circuitry can include at least one of left pressure source circuitry, such as coupled to the left control circuitry 140 A, or right pressure source circuitry, such as coupled to the right control circuitry 140B.

[00292] The system control circuitry 1140 can be configured to facilitate, coordinate, and control operation of the apparatus 1100, such as in a master- slave control configuration. In an example, a first control circuitry can receive and process an indication of the eye environment and a second control circuitry, in communication with the first control circuitry, can receive the processed indication from the first control circuitry and adjust operation of the apparatus 1100, such as at least one of the left system 1102 or the right system 1104. In an example, the first control circuitry can include the left control circuitry 140 A and the second control circuitry can include the right control circuitry 140B. In an example, the first control circuitry can include the right control circuitry 140B and the second control circuitry can include the left control circuitry 140 A. [00293] FIG. 8 shows an example of an apparatus 1200 that can control a left eye environment over a left eye of a patient and a right eye environment over a right eye of the patient, such as with a single pressure source. In an example, the apparatus 1200 can be operated with a single control system, such as the eye environment in the left cavity 112A and the eye environment in the right cavity 112B can be controlled to have the same eye environment in each cavity. For example, the apparatus 1200 can be operated, such as cavity pressure in the left cavity 112A can be equal to, such as approximately equal to, cavity pressure in the right cavity 112B.

[00294] The apparatus 1200 can include a cavity valve 1290, such as at least one of a left cavity valve 1290 A or a right cavity valve 1290B. The apparatus 1200 can include a cavity reservoir 1292, such as at least one of a left cavity reservoir 1292 A or a right cavity reservoir 1292B. In an example, the apparatus 1200 can be operated with independent control of the eye environment, such as control of the left eye environment can be independent of control of the right eye environment and control of the right eye environment can be independent of the left eye environment. For example, the apparatus 1200 can be operated, such as cavity pressure in the left cavity 112A can be different from cavity pressure in the right cavity 112B, such as by appropriate control of the cavity valve 1290 and the cavity reservoir 1292.

[00295] The apparatus 1200 can include a cavity valve 1290, such as the cavity valve 1290 in communication with the cavity 112. The cavity valve 1290 can be in communication with, such as coupled to, at least one of the sensor 130, the control circuitry 140, or the pressure source 150. In an example, the cavity valve 1290 can include at least one of a left control valve 1290 A in communication with the left cavity 112A or a right control valve 1290B in communication with the right cavity 112B. [00296] The cavity valve 1290 can control working fluid pressure in the cavity 112, such as to achieve a target cavity pressure in the cavity 112. Referencing FIG. 8, the left control valve 1290A can control working fluid pressure in the cavity 112A and the right control valve 1290B can control working fluid pressure in the cavity 112B.

[00297] The apparatus 1200 can include a cavity reservoir 1292, such as the cavity reservoir 1292 in communication with the cavity 112. The cavity reservoir 1292 can include at least one of a left cavity reservoir 1292 A and a right cavity reservoir 1292B.

[00298] The cavity reservoir 1292 can serve to adjust an indication of system elastance in the apparatus 1200, such as to improve the ability of the apparatus 1200 to achieve a target cavity pressure. System elastance can be characterized by at least one of the ratio of change in pressure for a given change in volume, such as E=DR/Dn, or the inverse of system compliance, such as C= 1/E=Dn/DR. In an example, an indication of system elastance can be equivalent to an indication of component elastance and an indication of system compliance can be equivalent to an indication of component compliance. A fluidic system with “high” elastance implies a fluidic system that can experience rapid pressure change as a function of volume change. In an example, an active cavity valve can fail to achieve the target cavity pressure in an apparatus 1200 with high elastance, such as due to slow feedback response resulting in overshooting the target cavity pressure. By adjusting elastance, such as by reducing system elastance or increasing system compliance, control of the apparatus 1200 can be improved, such as by reducing the rate of pressure change due to volume change to minimize feedback tracking error.

[00299] The cavity reservoir 1292 can include a supplementary volume, such as a volumetric space in communication with the cavity 112, including at least one of a fluidic accumulator or an expansion chamber. In an example, a supplementary volume can be defined as any additional volume of the cavity 112, such as any component in fluidic communication with the cavity 112, beyond the minimum volume required to convey pressure to the patient eye. [00300] The amount of supplementary volume in the cavity reservoir 1292 can be selected, such as to adjust the system elastance to change system lag and error when pressurizing the apparatus 1200. Supplementary volume can be adjusted from a first supplementary volume level to a second supplementary volume. In an example, the second supplementary volume level can be less than the first supplementary volume level, such as to increase system elastance. In increasing system elastance, system lag for the apparatus 1200, including pressure system lag, can be reduced. In an example, the second supplementary volume level can be greater than the first supplementary volume level, such as to reduce system elastance. In reducing system elastance, system lag for the apparatus 800, including pressure system lag, can be increased.

[00301 j The cavity reservoir 1292 can include a compliant portion of the apparatus 1200, such as a compliant portion of the apparatus 1200 in communication with the cavity 112. A compliant portion can include a portion of the apparatus 1200 in fluidic communication with the cavity 112, such as a portion of the apparatus 1200 that demonstrates a percentage variation in component compliance greater than the least compliant component of the cavity 112 or any component in fluidic communication with the cavity 112. The percentage variation in component compliance can be in a range of at least one of about 1% to about 25%, about 25% to about 50%, about 50% to about 75%, or about 75% to about 100% as compared to the least compliant component of the system.

[00302] The compliant portion can include an elastic portion, such as a portion of the apparatus 1200 in communication with the cavity 112 that demonstrates a percentage variation in component compliance greater than the least compliant component of the system. In an example, an elastic portion can include a membrane, such as the flexible septum as noted previously in this application. [00303] FIG. 9 shows an example method 1300 for using the apparatus 100 to adjust an indication of a physiological parameter in a patient, such as the patient associated with positive airway pressure (PAP) patient perception of an indication of a headache symptom. The control circuitryl40 can be configured to receive an indication from a user, such as an indication of a target cavity pressure level selected to adjust the indication of the physiological parameter in the patient, and process the received indication, such as to adjust the pressure level in the cavity 112 toward the indication of the target cavity pressure level received from the user. In an example, the control circuitry 140 can adjust the cavity pressure from a first indication of cavity pressure to a second indication of cavity pressure, such as approximately equivalent to the target cavity pressure level, such as to adjust the indication of the physiological parameter.

[00304] At step 1310, a patient, such as a patient associated with PAP therapy, can be selected or presented, such as for treatment with the apparatus 100. Selection of the patient can include identification of a patient who might benefit from the apparatus 100, such as by beneficial adjustment of a physiological parameter of the patient by the apparatus 100. In an example, selection of a patient can include identification of a patient with at least one of an indication of an eye condition, such as a symptom of an eye condition, or an indication of a sleep-related disorder, such as a symptom of a sleep-related disorder. In an example, presentation of a patient can include identification of a patient previously selected as displaying with at least one of an indication of an eye condition or an indication of a sleep-related disorder.

[00305] At step 1320, non-ambient pressure can be applied to a cavity 112, such as the cavity 112 defined by a cover 110 over the eye of a patient, the level of non-ambient pressure applied to the cavity 112 based at least in part on an indication of PAP applied to the patient. Applying non-ambient pressure to the cavity 112 can include changing pressure in the cavity 112, such as from a first pressure, such as including an ambient pressure, to a second pressure, such as a non-ambient pressure different from the first pressure.

[00306] Applying non-ambient pressure can include applying an external force to the cover 110, such as to compress at least one of the seal 119 or patient tissue, such as to decrease the volume of the cavity 112, such as to increase gauge pressure in the cavity 112. A positive pressure check valve, such as in communication with the cavity 112, can release positive gauge pressure from the cavity 112, such as limited by the cracking pressure of the positive pressure check valve. Applying non-ambient pressure can include releasing the external force from the cover 110, such as to allow the seal 119 or patient tissue to rebound, such as to decrease gauge pressure in the cavity 112. Applying non ambient pressure can include regulating gauge pressure in the cavity 112, such as with a negative pressure check valve, such as with a cracking pressure selected to adjust non-ambient pressure in the cavity toward a target cavity pressure level.

[00307] Applying non-ambient pressure can include applying non-ambient pressure to the cavity 112 with a pressure source 150, such as toward a target cavity pressure level.

[00308] At step 1330, the non-ambient pressure applied to the cavity can be adjusted toward a target cavity pressure level. A target cavity pressure level can include at least one of a target IOP cavity pressure level, a target blood flow cavity pressure level, or a target OPP cavity pressure level. In an example, the target cavity pressure level can be based at least in part on the indication of PAP applied to the patient.

[00309] Adjusting the applied non-ambient pressure can include adjusting the cavity pressure toward an applied force target cavity pressure level. The applied force target cavity pressure level can be received, such as from a user specifying an applied force target cavity pressure level through an interface in communication with the control circuitry 140.

[0031 ] Adjusting the applied non-ambient pressure can include specifying a target cavity headache pressure value, such as by communicating the target cavity headache pressure value to the control circuitry 140 including inputting the value through a GUI attached to the control circuitry 140. Adjusting the applied non-ambient pressure can include operating a feedback control loop, such as running on the control circuitry 140, to minimize an error between the target cavity pressure value and an indication of cavity pressure in the cavity 112. In an example, cavity pressure can be sensed by a sensor 130, such as a pressure sensor located in communication with the cavity 112.

[00311] The applied force target cavity pressure level can be identified, such as by initiating a pressure sweep test with the sweep circuitry associated with the control circuitry 140 and collecting feedback, such as from a sensor 130. The control circuitry 140 can process the data received, such as to identify one or more sweep pressure levels that can adjust the indication of the physiological parameter and store the identified sweep pressure levels as one or more applied force target cavity pressure levels. The pressure sweep test can be conducted periodically, such as to update the applied force target cavity pressure levels. [00312] A translaminar pressure difference (TPD) can be defined as an indication of the difference between intraocular pressure (IOP) level in the patient eye and the intracranial pressure (ICP) level in the patient skull, such as across a lamina cribrosa of the patient eye (e.g„ TPD = IOP - ICP). A TPD level can provide an important early indication of the presence of an eye condition in a patient, such as glaucoma or papilledema, prior to the patient presenting with a symptom of the eye condition. Identification of the eye condition can prompt medical intervention, such as to mitigate potential consequences of the eye condition.

[00313] The TPD level range can indicate the state condition of a patient eye. In an example, a patient eye, such as a physiologically normal patient eye, can be characterized by a TPD level range, such as a physiologically normal eye can include the patient eye with a TPD level in a range of about -5 mmHg to about 5 mmHg. In an example, a patient eye, such as a physiologically abnormal patient eye or a patient eye with an eye condition, can be characterized by a TPD level range, such as a TPD level falling outside of a range of about -5 mmHg to about 5 mmHg. The TPD level of a patient falling outside the range of about -5 mmHg to about 5 mmHg can indicate the presence of an eye condition, such as an eye condition that can be at least one of diagnosed, inhibited, or treated with the subject matter of this application. In an example an adjustment to the indication of TPD can occur, such as through adjustment of at least one of the IOP level in the patient eye or the ICP level in the patient.

[00314] Adjustment of ICP level can be achieved, such as by adjustment of venous flow from the patient head. Adjustment can include modulation of venous flow through a venous vessel traversing the patient neck, such as traversing flow from the patient head to the patient torso through the venous vessel. In an example, the venous vessel can include at least a portion of the cerebrospinal venous system in the patient including at least a portion of at least one of an intrinsic venous system, extrinsic venous system, or extradural venous system in the patient. The spinal venous system can include a vertebral venous system in the patient. The spinal venous system can include a vein of a neck of the patient. The vein of the neck of the patient can include at least one of an external jugular vein and tributaries of the external jugular vein, a posterior jugular vein and tributaries of the posterior external jugular vein, an anterior jugular vein, an internal jugular vein, an inferior petrosal sinus, a lingual vein, a pharyngeal vein, a superior thyroid vein, a middle thyroid vein, a common facial vein, an occipital vein, a vertebral vein, an anterior vertebral vein, or a deep cervical vein.

[00315] Adjustment of venous flow can include reduction of venous flow, such as by occlusion of the spinal venous system. Since a patient skull defines a fixed volume within the cranial cavity, occlusion of the spinal venous system can cause fluid to accumulate in the patient skull, such as to increase the volume of fluid in the fixed volume cranial cavity, thereby increasing ICP in the patient skull, such as from a baseline ICP level.

[00316] Adjustment of venous flow can include augmentation of venous flow, such as by dilatation of the spinal venous system. Dilation of the venous system can reduce resistance to fluid flow, such as from the patient skull to the patient intrathoracic cavity, thereby decreasing ICP in the patient skull, such as from a baseline ICP level.

[00317] A valve, such as an implantable shunt, can be implanted in a patient, such as to control venous flow. The valve can include at least one of a passive valve, such as a check valve including a flapper valve or a poppet valve, or an active valve, such as a transcutaneously activated valve including a magnetically actuated transcutaneous shunt valve. In an example, the valve can reduce venous flow, such as by adjusting the valve from an “open” position to a “closed” position. In an example, the valve can augment venous flow, such as by adjusting the valve from a “closed” position to an “open” position.

[00318] An ICP force generator can apply an external force, such as at least one of a positive or negative external force, to a patient, such as to adjust or control an indication of ICP in the patient. The ICP force generator can include an ICP force carrier, such as sized and shaped to be worn by or otherwise located against a neck or lower external portion of the patient. The ICP force generator can include an ICP force applicator, such as sized and shaped for applying or concentrating at least one of a positive or negative external force to a selected region of the neck or lower external portion of the patient, such as to affect an indication of ICP in the patient. [00319] FIGS. 19A and 19B show front and side views of an example ICP force generator, such as an occlusive collar 310. In an example, the occlusive collar 310 can be configured to adjust a physiological parameter in a patient, such as an indication of an intracranial pressure (ICP) level in the patient. The occlusive collar 310 can include at least one of an ICP force carrier, such as a collar frame 312, an ICP force applicator, such as a protrusion 314, and a collar link, 316.

[00320] The collar frame 312 can be configured to encircle the patient neck, such as at least a portion of the patient neck. The collar frame 312 can include a gap, such as a distance between a first end 315 of the collar frame 312 and a second end 317 of the collar frame 312. The gap can allow the collar frame 312 to be located around at least a portion of the neck, such as to allow the patient to adjust the location of the collar frame 312 about the patient neck for comfort of the patient. In an example, the collar frame 312 can completely encircle the patient neck, such as the first end 315 and the second end 317 can be joined to form a continuous collar frame 312 without a gap. The continuous collar frame 312 can be constructed from an elastic material, such as the continuous collar frame 312 can be stretched over the head for location around the patient neck. In an example, the continuous collar frame 312 can include a gathering device, such as an auto buckle friction device, to shorten the circumference of the continuous collar frame 312.

[00321] The protrusion 314 can attach to a surface of the collar frame 312, such as the surface of the collar frame 312 generally facing toward the patient.

In an example, the protrusion 314 can be located between the collar frame 312 and the patient. In an example, the protrusion 314 can be configured to apply pressure, such as compressive pressure, to at least a portion of the patient neck, such as at least a portion of the spinal venous system in the patient neck, to adjust a physiological parameter in the patient. In an example, the protrusion 314 can be located between the collar frame 312 and the patient, such as in mechanical contact with both the collar frame 312 and the patient.

[00322] The protrusion 314 can include at least one of a passive protrusion structure, such as a protrusion 314 formed from an open-cell foam or a closed cell foam, or an active protrusion structure, such as at least one of a pneumatic bladder or a hydraulic bladder, such as in communication with a pressure source 150 to adjust fluid pressure in the bladder. The bladder can generate an external force against the patient, such as at least one of positive or negative force. In an example, the bladder can be located between the collar frame 312 and the patient, such as to generate an external force against the patient neck by adjustment of fluid pressure in the bladder.

[00323] The protrusion 314 can be located at any position along the collar frame 312, such as at a position in proximity to a venous vessel, to generally occlude venous outflow from the patient head. The collar frame 312 can include one or more protrusion 314, such as one or more protrusion 314 distributed along the collar frame 312 and located to occlude venous outflow. In an example, the one or more protrusion 314 can include at least one of an active protrusion structure. Fluid pressure adjustment in the active protrusion structure can selectively apply an external force to the patient, such as to selectively concentrate the external force against the patient to affect an indication of ICP in the patient. In an example, the passive protrusion 314 can be located against the patient and the collar frame 312 tightened, such as to selectively generate an external force against the patient. In an example, the active protrusion 314, such as the bladder including one or more bladders, can be pressurized independently, such as to selectively generate an external force against the patient. The protrusion 314 can assume any shape, such as a generally rectangular shape as shown in FIG. 23.

[00324] The collar link 316 can attach to the collar frame 312, such as a first portion of the collar link 316 can attach to the first end 315 and a second portion of the collar link 316 can attach to the second end 317, such as to form a continuous collar frame 312. The collar link 316 can be adjustable, such as to change the distance between the first end 315 and the second end 317. In an example, the collar frame 312 can be located to encircle the patient neck and the collar link 316 can be adjusted, such as to draw the first end 315 and the second end 317 to reduce the distance between the first and second ends 315, 317. Adjustment of the collar link 316 can allow adjustment of pressure to the patient neck provided by the protrusion 314, such as increasing pressure applied to the patient neck by decreasing the gap between the first and second ends 315, 317 or decreasing pressure applied to the patient neck by increasing the distance between the first and second ends 315, 317. In an example, the collar link 316 can include a passive link, such as a friction buckle or a tumbuckle, or an active link, such as an actuator attached to a passive link where the actuator can be configured to tighten or loosen the passive link. The active link can be in communication with the control circuitry 140, such as to implement at least one of a position-based or force-based feedback control algorithm to control the external force, such as applied to the patient.

[00325] The occlusive collar 310 can constitute a means to adjust an indication of ICP of the patient, such as by selectively applying an external force to a selected region of the patient neck. In an example, the collar link 316 can be adjusted, such as to create an adjustable tension force in the collar frame 312 and the collar link 316. The adjustable tension force can be configured, such as selected by a user or the patient, to create an adjustable external force, such as an adjustable positive external force, against at least a portion of the patient neck. The external force can be configured to generate contact pressure against the patient, such as to controllably compress a venous vessel in the patient neck to adjust or modulate venous fluid outflow from the patient head.

[00326] Due to naturally-occurring differences in patient anatomy, the location of the venous vessel for occlusion can vary from patient to patient. The adjustable external force can be selectively applied to the patient, such as between the collar frame 312 and the patient, and by locating the protrusion 314 in proximity to the venous vessel, such as for at least one of occlusion or augmentation of venous flow. In an example, the adjustable external force generated by the protrusion 314, such as at least one of the open-cell foam or the closed-cell foam protrusion 314, can be varied by the adjustable tension force in the collar frame 312, such as by adjusting the collar link 316. In an example, the adjustable external force generated by the protrusion 314, such as at least one of the hydraulic bladder or the pneumatic bladder protrusion 314, can be varied by changing the pressure of fluid inside the bladder.

[00327] In an example, an indication of TPD level can be sensed in a patient. The TPD level can be adjusted, such as by adjusting ICP level in the patient. For example, the occlusive collar 310 can be located on the patient, such as encircling at least a portion of the patient neck, and compressive force applied to the patient neck. The compressive force can be applied with the occlusive collar 310, such as to occlude venous outflow from the patient head to the patient torso to increase ICP level in the patient.

[00328] FIGS. 20A and 20B show front and side views of an example ICP force generator, such as a pressure collar 320 configured to adjust a physiological parameter in a patient including an ICP level in the patient. The pressure collar 320 can include a collar pressure cover 322, such as a left collar pressure cover 322A and a right collar pressure cover 322B, and a collar pressure cavity 324, such as a left collar pressure cavity 324A and a right collar pressure cavity 324B.

[00329] The collar pressure cover 322 can be configured to encircle the patient neck, such as at least a portion of the patient neck. The cover 322 can include a shell, such as a structure with a concave shell surface generally facing toward the patient neck, a convex shell surface generally facing away from the patient neck, and a shell edge denoting the intersection of the concave shell surface with the convex shell surface. The cover 322 can include a collar link 326 configured to secure the left collar pressure cover 322A to the right collar pressure cover 322B, such as to locate the cover 322 around the patient neck. The collar link 326 can be adjustable, such as to allow the collar link 326 to be shortened or lengthened, such as to control the circumference of the pressure collar 320 formed by the left pressure cover 322A and the right pressure cover 322B. [00330] The cover 322 can include a bladder, such as at least one of a hydraulic bladder or a pneumatic bladder. The bladder can be connected to a pressure source, such as the external force applied to the patient can be varied by changing the pressure of fluid inside the bladder. A collar link 326 can secure a left collar bladder 322A to a right collar bladder 322B, such as to locate the bladder around the patient neck.

[00331] The cover 322 can define the collar pressure cavity 324, such as the volume between the concave shell surface and the patient neck tissue when the cover 322 is placed against the patient neck. In an example, the shell edge of the cover 322 placed against the patient can contact at least a portion of patient tissue proximal to the patient neck, such as to form the cavity 324 over the patient neck. The cover 322 can be configured to form one or more cavities 324 over patient neck tissue. In an example, the one or more cavities 324 can act as a protrusion 314, such as at least one of a passive protrusion 314 or an active protrusion 314. In an example, the passive protrusion 314 can be located against the patient and the collar frame 312 tightened, such as to selectively generate an external force against the patient. In an example, the active protrusion 314, such as the bladder including one or more bladders, can be pressurized independently, such as to selectively generate an external force against the patient. In an example, the one or more protrusion 314 can include at least one of an active protrusion structure. Fluid pressure adjustment in the active protrusion structure can selectively apply an external force to the patient, such as to selectively concentrate the external force against the patient to affect an indication of ICP in the patient.

[00332] The cavity 324 can include a spatial volume, such as the spatial volume defined between the concave shell surface of the cover 322 and patient neck tissue. The cavity 324 can contain a working fluid, such as a liquid or a gaseous fluid, that can form at least part of an environment in contact with the patient tissue, such as the patient neck tissue. The cover 322 can include a gasket, such as located along the shell periphery, that can be positioned in contact with the patient neck, such as to form a seal with the patient tissue to isolate the cavity 324 from the surrounding environment.

[00333] The cover 322 can include a cover membrane. The cover membrane can attach to at least a part of the shell edge of the cover 322, such as to isolate the cavity 324 from the surrounding environment. The cover membrane can act as at least one of a semi-permeable or impermeable membrane. In an example, the cover membrane can support a pressure differential, such as at least one of a positive gauge pressure or a negative gauge pressure, between the cavity 324 and the surrounding environment. Pressurizing the cover membrane can allow the cover membrane to transfer an external force, such as at least one of a positive external force or a negative (e.g., suction) external force to the patient tissue. In an example, the cover 322 with the cover membrane can be located against patient tissue, such as at least one of the patient neck or lower external portion of the patient, such as the shell edge can isolate the cover membrane in contact with the patient tissue from the surrounding environment. Applying a positive pressure to the cavity 324 can press the membrane against the patient tissue, such as to apply a positive external force (or occlusive force) to the tissue. Applying a negative pressure to the cavity 324 can draw the membrane into the cavity, such as to create a void between the membrane and the tissue to create a region of negative pressure, such as to apply a negative (e.g., suction) external force to dilate the tissue. The cavity 324 can be in communication with a pressure source 150, such as to vary the magnitude or level of the external force applied to the tissue.

[00334] The cover 322 can be configured to form one or more cavities 324 and the cover membrane can be connected to the cover edge, such as the cover edge associated with the one or more cavities 324, such as to form one or more protrusions 314, including an active protrusion 314, against the patient tissue. In an example, the active protrusion 314, such as the bladder including one or more bladders, can be pressurized independently, such as to selectively generate an external force against the patient. In an example, the one or more protrusions 314 formed by the one or more cavities 324 can include at least one of an active protrusion structure. Adjustment of fluid pressure in the active protrusion 314 can selectively apply an external force to the patient, such as to selectively concentrate the external force against the patient to affect an indication of ICP in the patient

[00335] The cover 322 can include a collar pressure port 328, such as extending from the convex surface of the cover 322 to the concave surface of the cover 322. The left cover 322A can include a left collar pressure port 328A and the right cover 322B can include a right collar pressure port 328B. In an example, the collar pressure port 328 can place the cavity 324 in communication with the pressure source 150, such as with a collar pressure conduit 327, to adjust fluid pressure in the cavity 324.

[00336] The cover 322 can include a cavity check valve 189, such as to control the pressure level applied to the cavity 324. The cavity check valve 189 can be located in communication with the cavity 324, such as at least one of on the cover 322 including a left check valve 189 on the left cover 322A and a right check valve 189 on the right cover 322B, the conduit 327, the control circuitry 140, or the pressure source 150.

[00337] The cover 322 can support a differential fluid pressure, such as a gauge pressure of the working fluid in the cavity 324, in contact with patient tissue. In an example, gauge pressure can be defined as the difference in pressure between the working fluid pressure in the cavity 324 and atmospheric pressure surrounding the cover 322. The cover 322 can be configured to maintain the shape of the cavity 324 in the presence of gauge pressure in the cavity, such as gauge pressure in the range of about -200 mmHg to about 200 mmHg.

[00338] A positive gauge pressure, such as where working fluid pressure in the cavity 324 is greater than atmospheric pressure, can create a compressive force on patient tissue, such as to compress the neck tissue influenced by the pressure in the cavity 324. Compression of the neck tissue, such as including the spinal venous system, can generally occlude venous outflow from the patient head, such as to increase ICP.

[00339] The magnitude of the compressive force can be related to the positive gauge pressure applied to the cavity 324. In an example, the compressive force can include the force resulting from a positive gauge pressure applied to the cavity 324, such as a range of positive gauge pressure including at least one of a range of about 0 mmHg to about 10 mmHg, a range of about 10 mmHg to about 20 mmHg, a range of about 20 mmHg to about 30 mmHg, a range of about 30 mmHg to about 40 mmHg, a range of about 40 mmHg to about 50 mmHg, a range of about 50 mmHg to about 60 mmHg, a range of about 60 mmHg to about 70 mmHg, a range of about 70 mmHg to about 80 mmHg, a range of about 80 mmHg to about 90 mmHg, a range of about 90 mmHg to about 100 mmHg, or a range of about 100 mmHg to about 200 mmHg.

[00340] A negative (or “vacuum”) gauge pressure, such as where working fluid pressure in the cavity 324 is less than atmospheric pressure, can create a suction force on patient tissue, such as to decompress the neck tissue influenced by the pressure environment in the cavity 324, and generally increase venous outflow from the patient head, such as to reduce ICP.

[00341] The suction force can be related to the negative gauge pressure applied to the cavity 324. In an example, the suction force can include the force resulting from a negative gauge pressure, such as a range of negative gauge pressure including at least one of a range of about 0 mmHg to about -10 mmHg, a range of about 0 mmHg to about -10 mmHg, a range of about -10 mmHg to about -20 mmHg, a range of about -20 mmHg to about -30 mmHg, a range of about -30 mmHg to about -40 mmHg, a range of about -40 mmHg to about -50 mmHg, a range of about -50 mmHg to about -60 mmHg, a range of about -60 mmHg to about -70 mmHg, a range of about -70 mmHg to about -80 mmHg, a range of about -80 mmHg to about -90 mmHg, a range of about -90 mmHg to about -100 mmHg, or a range of about -100 mmHg to about -200 mmHg.

[00342] In an example, an indication of TPD level can be sensed in a patient. The TPD level can be adjusted, such as by adjusting ICP level in the patient.

The pressure collar 320 can be located on the patient, such as encircling at least a portion of the patient neck. A compressive force can be applied to the patient neck, such as by applying positive pressure to the pressure collar cavity 324 to occlude venous outflow from the patient head to the patient torso to increase ICP level in the patient. A decompressive force can be applied to the patient neck, such as by applying negative pressure to the pressure collar cavity 324 to enhance venous outflow from the patient head to the patient torso to decrease ICP level in the patient

[00343] Adjustment of ICP level can be achieved, such as by adjustment of at least one of intrathoracic pressure or intra-abdominal pressure in the patient. Adjustment in at least one of intrathoracic pressure or intra-abdominal pressure can affect cerebral venous outflow, such as through at least a portion of the spinal venous system in the patient.

[00344] Fluid can flow naturally from a region of high pressure to a region of low pressure, such as from a region of fluid at a first pressure to a region of fluid at a second pressure where the second pressure is less than the first pressure. In an example, a patient in a standing position can experience venous fluid flow from a first region at a first pressure, such as from the patient head at an initial ICP level, to a second region at a second pressure, such as to the patient thorax at an initial intrathoracic pressure level less than the initial ICP level.

[00345] The rate of fluid flow from the patient head to the patient thorax can depend on a relationship between ICP and intrathoracic pressure, such as the difference between ICP and intrathoracic pressure. Further, the rate of venous fluid flow from the patient head to the patient thorax can be adjusted, such as through adjustment of at least one of the ICP or the intrathoracic pressure. [00346] Reducing the difference between ICP and intrathoracic pressure can increase ICP in the patient head, such as by reducing venous outflow from the patient head. Since a patient skull defines a fixed volume within the cranial cavity, reducing venous outflow can cause fluid to accumulate in the patient skull, such as to increase the volume of fluid in the fixed volume cranial cavity, thereby increasing ICP in the patient skull. In an example, adjusting the intrathoracic pressure level to decrease the difference between ICP and the intrathoracic pressure level can increase ICP level in the patient.

[00347] FIGS. 21 A and 21B show front and side views of an example ICP force generator, such as a pressure vest 350. The pressure vest 350 can be configured to adjust a physiological parameter in a patient, such as the ICP level in the patient. The pressure vest 350 can adjust at least one of intrathoracic pressure level in the patient, such as to increase or decrease intrathoracic pressure level, or abdominal pressure level in the patient, such as to increase or decrease abdominal pressure level. In an example, the pressure vest 350 can include a fluid pressure garment 351, including a torso pressure cover 352, a torso pressure cavity 354, an abdominal pressure cover 362, and an abdominal pressure cavity 364.

[00348] The torso pressure cover 352 can be configured to encircle a patient torso, such as at least a portion of the patient torso. In an example, the patient thorax can be generally located between the neck and a patient abdomen. The cover 352 can include a torso shell, such as a structure with a concave torso shell surface generally facing toward the patient torso, a convex torso shell surface generally facing away from the patient torso, and a shell edge denoting the intersection of the concave torso shell surface with the convex torso shell surface.

[00349] The abdominal pressure cover 362 can be configured to encircle the patient abdomen, such as at least a portion of the abdomen. In an example, the patient abdomen can be generally located between the patient thorax and a patient pelvis. The cover 362 can include an abdominal shell, such as a structure with a concave abdominal shell surface generally facing toward the patient abdomen, a convex abdominal shell surface generally facing away from the patient abdomen, and a shell edge denoting the intersection of the concave abdominal shell surface with the convex abdominal shell surface.

[00350] The garment 351 can include a garment link 356 configured to secure a front pressure garment 351 A to a rear pressure garment 35 IB, such as locate the pressure garment 351 around a least one of the patient torso or the patient abdomen. The garment link 356 can be adjustable, such as to allow the garment link 356 to be shortened or lengthened, such as to control the circumference of the pressure garment 351 formed around at least one of the patient torso or the patient abdomen by the front torso pressure garment 351 A and the rear torso pressure garment 35 IB.

[00351] The cover 352 can define the torso pressure cavity 354, such as the volume between the concave torso shell surface and the patient tissue when the cover 352 is placed against the patient torso. In an example, the shell edge of the cover 352 placed against the patient can contact at least a portion of patient tissue proximal to the patient torso, such as to form the cavity 354 over the patient torso. The cover 352 can be configured to form one or more cavities 354 over patient torso tissue, such as to isolate portions of the patient torso for application of different gauge pressure.

[00352] The cover 362 can define the abdominal pressure cavity 364, such as the volume between the concave abdominal shell surface and the patient tissue when the cover 362 is placed against the patient abdomen. The cover 362 can be configured to form one or more cavities 364 over patient abdominal tissue, such as to isolate portions of the patient abdomen for application of different gauge pressure.

[00353] The cavity 354 can include a spatial volume, such as the spatial volume defined between the concave shell surface of the cover 352 and patient torso tissue. The cavity 354 can contain a working fluid, such as a liquid or a gaseous fluid, that can form at least part of an environment in contact with the patient torso tissue. The cover 352 can include a gasket, such as located along the torso shell periphery, that can be positioned in contact with the patient torso, such as to form a seal with the patient tissue to isolate the cavity 354 from the surrounding environment.

[00354] The cavity 364 can include a spatial volume, such as the spatial volume defined between the concave shell surface of the cover 352 and patient abdominal tissue. The cavity 364 can contain a working fluid, such as a liquid or a gaseous fluid, that can form at least part of an environment in contact with the patient abdominal tissue. The cover 362 can include a gasket, such as located along the abdominal shell periphery, that can be positioned in contact with the patient abdomen, such as to form a seal with the patient tissue to isolate the cavity 364 from the surrounding environment.

[00355] The cover 352 can include a torso cover port 358, such as extending from the convex surface of the cover 352 to the concave surface of the cover 352. The torso cover port 358 can include a front torso cover port 358A and a rear torso cover port 358B. In an example, the torso cover port 358 can place the cavity 354 in communication with the pressure source 150, such as with a conduit or pressure hose.

[00356] The cover 362 can include an abdominal cover port 368, such as extending from the convex surface of the cover 362 to the concave surface of the cover 362. The abdominal cover port 368 can include a front torso cover port 368 A and a rear torso cover port 368B. In an example, the abdominal cover port 368 can place the cavity 364 in communication with the pressure source 150, such as with a conduit or pressure hose.

[00357] The cover 352 can include a cavity check valve 189, such as to control the pressure level applied to the cavity 354. The cavity check valve 189 can be located in communication with the cavity 354, such as on at least one of the cover 352 including a left check valve 189 on the front cover 352 A and a right check valve 189 on the rear cover 352B, the conduit or pressure hose, the control circuitry 140, or the pressure source 150.

[00358] The cover 362 can include a cavity check valve 189, such as to control the pressure level applied to the cavity 364. The cavity check valve 189 can be located in communication with the cavity 364, such as on at least one of the cover 362 including a left check valve 189 on the front cover 362A and a right check valve 189 on the rear cover 362B, the conduit or pressure hose, the control circuitry 140, or the pressure source 150. [00359] The cover 352 can support a differential fluid pressure, such as a gauge pressure of the working fluid in the cavity 354, in contact with patient tissue. In an example, gauge pressure can be defined as the difference in pressure between the working fluid pressure in the cavity 354 and atmospheric pressure surrounding the cover 352. The cover 352 can be configured to maintain the original shape of the cavity 354 in the presence of a gauge pressure in the cavity, such as a gauge pressure in the range of about -200 mmHg to about 200 mmHg.

[00360] The cover 362 can support a differential fluid pressure, such as a gauge pressure of the working fluid in the cavity 364, in contact with patient tissue. In an example, gauge pressure can be defined as the difference in pressure between the working fluid pressure in the cavity 364 and atmospheric pressure surrounding the cover 362. The cover 362 can be configured to maintain the original shape of the cavity 364 in the presence of a gauge pressure in the cavity, such as a gauge pressure in the range of about -200 mmHg to about 200 mmHg.

[00361] A positive gauge pressure, such as where working fluid pressure in the cavity 354 is greater than atmospheric pressure, can create a compressive force on patient tissue, such as to compress the torso tissue influenced by the pressure in the cavity 354, and generally increase intrathoracic pressure, such as to decrease differential pressure between the patient head and the patient torso and thereby occlude venous outflow from the patient head to increase ICP.

Similarly, a positive gauge pressure, such as where working fluid pressure in the cavity 364 is greater than atmospheric pressure, can create a compressive force on patient tissue, such as to compress the abdominal tissue influenced by the pressure in the cavity 364, and generally increase abdominal pressure, such as to decrease differential pressure between the patient head and the patient abdomen and thereby occlude venous outflow from the patient head to increase ICP. [00362] The magnitude of the compressive force can be related to the positive gauge pressure applied to at least one of the cavity 354 or the cavity 364. In an example, the compressive force can include the force resulting from a positive gauge pressure applied to at least one of the cavity 354 or the cavity 364, such as a range of positive gauge pressure including at least one of a range of about 0 mmHg to about 10 mmHg, a range of about 10 mmHg to about 20 mmHg, a range of about 20 mmHg to about 30 mmHg, a range of about 30 mmHg to about 40 mmHg, a range of about 40 mmHg to about 50 mmHg, a range of about 50 mmHg to about 60 mmHg, a range of about 60 mmHg to about 70 mmHg, a range of about 70 mmHg to about 80 mmHg, a range of about 80 mmHg to about 90 mmHg, a range of about 90 mmHg to about 100 mmHg, or a range of about 100 mmHg to about 200 mmHg.

[00363] A negative (or “vacuum”) gauge pressure, such as where working fluid pressure in the cavity 354 is less than atmospheric pressure, can create a suction force on patient tissue, such as to decompress the torso tissue influenced by the pressure environment in the cavity 354, and generally decrease intrathoracic pressure, such as to increase differential pressure between the patient head and the patient torso and thereby enhance venous outflow from the patient head to decrease ICP. Similarly, a negative (or “vacuum”) gauge pressure, such as where working fluid pressure in the cavity 364 is less than atmospheric pressure, can create a suction force on patient tissue, such as to decompress the abdominal tissue influenced by the pressure environment in the cavity 364, and generally decrease abdominal pressure, such as to increase differential pressure between the patient head and the patient abdomen and thereby enhance venous outflow from the patient head to decrease ICP.

[00364] The suction force can be related to the negative gauge pressure applied to at least one of the cavity 354 or the cavity 364. In an example, the suction force can include the force resulting from a negative gauge pressure applied to at least one of the cavity 354 or the cavity 364, such as a range of negative gauge pressure including at least one of a range of about 0 mmHg to about -10 mmHg, a range of about 0 mmHg to about -10 mmHg, a range of about -10 mmHg to about -20 mmHg, a range of about -20 mmHg to about -30 mmHg, a range of about -30 mmHg to about -40 mmHg, a range of about -40 mmHg to about -50 mmHg, a range of about -50 mmHg to about -60 mmHg, a range of about -60 mmHg to about -70 mmHg, a range of about -70 mmHg to about -80 mmHg, a range of about -80 mmHg to about -90 mmHg, a range of about -90 mmHg to about -100 mmHg, or a range of about -100 mmHg to about -200 mmHg. [00365] In an example, the pressure vest 350 can include a pressure corset, such as a garment to encircle at least a portion of at least one of the patient thorax or the patient abdomen. The pressure corset can include an adjustable strap, such as adjustable strap to encircle at least a portion of at least one of the patient thorax or the patient abdomen. Adjusting the strap, such as to decrease the circumference of the strap encircling the patient, can compress patient tissue, such as to increase intrathoracic pressure and decrease venous drainage from the patient head to the patient torso, to increase patient ICP.

[00366] Translaminar pressure difference, such as across a lamina cribrosa of a patient eye, can be adjusted, such as with one or more devices disclosed in this application. In an example, TPD can be adjusted, such as by adjusting intraocular pressure (IOP) of the patient eye, such as with at least one of the apparatus 100, the apparatus 1100, or the apparatus 1200. In an example, TPD can be adjusted, such as by adjusting intracranial pressure (ICP) in the patient, such as with at least one of the apparatus 310, the apparatus 320, or the apparatus 350. In an example, TPD can be adjusted, such as by adjusting at least one of IOP or ICP through at least one of simultaneous or concurrent application of at least one of the apparatus 100, the apparatus 1100, the apparatus 1200, the apparatus 310, the apparatus 320, or the apparatus 350.

[00367] FIG. 22 shows an example of an apparatus 100 configured to adjust IOP level in a patient and an apparatus 310 configured to adjust ICP level in the patient. In an example, a user, such as at least one of the patient or a healthcare professional, can adjust at least one of IOP level, such as with the apparatus 100, or ICP level, such as with the apparatus 310, toward a TPD level, such as a target TPD level. The apparatus 100 and the apparatus 310 can be in communication with the control circuitry 140, such as the control circuitry 140 configured to adjust IOP level with the apparatus 100 and ICP level with the apparatus 310 toward a target TPD level.

[00368] In an example, an indication of TPD level can be sensed in a patient. The TPD level can be adjusted, such as by adjusting at least one of IOP level in the patient, such as with the apparatus 100, or ICP level in the patient, such as with the apparatus 310.

[00369] FIG. 23 shows an example of an apparatus 100 configured to adjust IOP level in a patient and an apparatus 320 configured to adjust ICP level in the patient. The apparatus 100 and the apparatus 320 can be in communication with the control circuitry 140, such as the control circuitry 140 configured to adjust IOP level with the apparatus 100 and ICP level with the apparatus 320 toward a target TPD level.

[00370] In an example, an indication of TPD level can be sensed in a patient. The TPD level can be adjusted, such as by adjusting at least one of IOP level in the patient, such as with the apparatus 100, or ICP level in the patient, such as with the apparatus 320.

[00371] FIG. 24 shows an example of a mask assembly 199 configured to adjust IOP level in a patient while delivering positive airway pressure (PAP) to the patient and an apparatus 310 configured to adjust ICP level in the patient. The apparatus 100 and the apparatus 310 can be in communication with the control circuitry 140, such as the control circuitry 140 configured to deliver PAP to the patient and adjust IOP level with the apparatus 100 and ICP level with the apparatus 310 toward a target TPD level.

[00372] In an example, an indication of TPD level can be sensed in a patient. The TPD level can be adjusted, such as by adjusting at least one of IOP level in the patient, such as with the apparatus 100, or ICP level in the patient, such as with the apparatus 310. In an example, at least one of the IOP level or the ICP level can be adjusted to compensate for the effect of an adjunct apparatus, such as a change in intrathoracic pressure due to delivery of PAP therapy to the patient.

[00373] FIG. 25 shows an example of a mask assembly 199 configured to adjust IOP level in a patient while delivering positive airway pressure (PAP) to the patient and an apparatus 320 configured to adjust ICP level in the patient. The apparatus 100 and the apparatus 320 can be in communication with the control circuitry 140, such as the control circuitry 140 configured to deliver PAP to the patient and adjust IOP level with the apparatus 100 and ICP level with the apparatus 320 toward a target TPD level.

[00374] In an example, an indication of TPD level can be sensed in a patient. The TPD level can be adjusted, such as by adjusting at least one of IOP level in the patient, such as with the apparatus 100, or ICP level in the patient, such as with the apparatus 320. In an example, at least one of the IOP level or the ICP level can be adjusted to compensate for the effect of an adjunct apparatus, such as a change in intrathoracic pressure due to delivery of PAP therapy to the patient.

[00375] FIG. 26 shows an example of an apparatus 100 configured to adjust IOP level in a patient and an apparatus 350 configured to adjust ICP level in the patient. The apparatus 100 and the apparatus 350 can be in communication with the control circuitry 140, such as the control circuitry 140 configured to adjust IOP level with the apparatus 100 and ICP level with the apparatus 350 toward a target TPD level.

[00376] FIG. 27 shows an example of a mask assembly 199 configured to adjust IOP level in a patient while delivering positive airway pressure (PAP) to the patient and an apparatus 350 configured to adjust ICP level in the patient.

The apparatus 100 and the apparatus 350 can be in communication with the control circuitry 140, such as the control circuitry 140 configured to deliver PAP to the patient and adjust IOP level with the apparatus 100 and ICP level with the apparatus 350 toward a target TPD level.

[00377] In an example, an indication of TPD level can be sensed in a patient. The TPD level can be adjusted, such as by adjusting at least one of IOP level in the patient, such as with the apparatus 100, or ICP level in the patient, such as with the apparatus 350. In an example, at least one of the IOP level or the ICP level can be adjusted to compensate for the effect of an adjunct apparatus, such as a change in intrathoracic pressure due to delivery of PAP therapy to the patient.

[00378] FIG. 28 shows an example of a method 2800 to adjust an indication of a physiological parameter, such as an indication of intracranial pressure (ICP) level in a patient, toward a target pressure, such as a target differential pressure range across a lamina cribrosa of the patient. The method 3200 can provide a therapeutic benefit to the patient, such as to adjust TPD level in the patient toward a target TPD level to treat an eye condition associated with a patient eye. [00379] At 2810, the method can include adjusting ICP level in the patient, such as with an ICP force generator in contact with the patient. Adjusting ICP level can include applying non-ambient pressure to the patient, such as in proximity to a venous vessel traversing the patient neck from the patient head to the patient torso through the venous vessel.

[00380] Applying a positive non-ambient pressure to the venous vessel can decrease venous flow from the patient head, such as to cause venous fluid to accumulate in the cranial cavity and increase the ICP level in the patient. In an example, applying positive non-ambient pressure can include compressing the venous vessel mechanically, such as through mechanical contact pressure. Mechanical contact pressure can be applied manually, such as through gentle massage, or with an ICPforce generator, such as the occlusive collar 310. In an example, applying positive non-ambient pressure can include compressing the venous vessel pneumatically, such as through pneumatic contact pressure. Pneumatic contact pressure can be generated with a ICP force generator, such as the pressure collar 320.

[00381] Applying a negative non-ambient pressure to the venous vessel can increase venous flow from the patient head, such as to evacuate venous fluid from the cranial cavity and decrease the ICP level in the patient. In an example, applying negative non-ambient pressure, such as a suction force, can decompress the venous vessel, such as to increase venous flow in the vessel. In an example, applying negative non-ambient pressure can include decompressing the venous vessel pneumatically, such as through pneumatic suction pressure. Pneumatic suction pressure can be generated with a ICP force generator, such as the pressure collar 320.

[00382] Adjusting ICP level can include applying non-ambient pressure to the patient, such as to at least one of a patient thorax or a patient abdomen.

[00383] Applying a positive non-ambient pressure to the patient thorax or patient abdomen can increase intrathoracic pressure and thereby decrease venous flow from the patient head, such as to cause venous fluid to accumulate in the cranial cavity and increase the ICP level in the patient. In an example, applying positive non-ambient pressure can include mechanically compressing at least one of the patient thorax or the patient abdomen, such as through mechanical contact pressure. Mechanical contact pressure can be applied with an ICP force generator, such as a pressure corset. In an example, applying positive non ambient pressure can include pneumatically, such as through pneumatic contact pressure. Pneumatic contact pressure can be generated with an ICP force generator, such as the pressure vest 350.

[00384] Applying a negative non-ambient pressure to at least one of the patient thorax or patient abdomen can decrease intrathoracic pressure and thereby increase venous flow from the patient head, such as to evacuate venous fluid from the cranial cavity and decrease the ICP level in the patient. In an example, applying negative non-ambient pressure can include decompressing at least a portion of at least one of the patient thorax or the patient abdomen pneumatically, such as through pneumatic suction pressure. Pneumatic suction pressure can be generated with an ICP force generator, such as the pressure vest 350.

[00385] At 2820, the method can include controlling adjustment of the ICP level in the patient, such as toward a target differential pressure range across the lamina cribrosa. Controlling ICP level can include sensing an indication of a physiological parameter of the patient. Sensing an indication of a physiological parameter can include sensing at least one of an indication of IOP, such as with a sensor configured to sense IOP, an indication of at least one of ICP, such as with a sensor configured to sense ICP, or CSFP, such as with a sensor configured to sense CSFP.

[00386] In an example, sensing an indication of a physiological parameter can include sensing a relationship between the indication of IOP and at least one of the indication of ICP or the indication of CSFP, such as the difference between IOP and ICP including an indication of TPD or an indication of a retinal cup-to- disc ratio on the patient eye.

[00387] In an example, sensing an indication of a physiological parameter can include sensing an indication of blood flow associated with the patient eye. An indication of blood flow can include an indication of at least one of blood flow volume through a retinal vessel in the patient eye, blood flow velocity in the retinal vessel, retinal vessel diameter, or a change in any one of the flow volume, flow velocity, or vessel diameter. An indication of blood flow can include an indication of spontaneous vessel pulsation, such as at least one of a spontaneous venous pulsation (SVP) or a spontaneous arterial pulsation (SAP). An indication of blood flow can include an indication of at least one of optic nerve head volume, optic nerve head position, choroidal volume, axonal transport, axial length, globe position, or a change in any one of the optic nerve head volume, optic nerve head position, choroidal volume, axonal transport, axial length, or globe position.

[00388] At 2830, the method can include selecting a patient, such as a individual examined by a medical professional. Selecting a patient can include diagnosing the patient, such as adjustment of ICP in the individual examined by the medical professional can lead to discovery of at least one of a symptom of an eye condition or a risk factor associated with an eye condition. Selecting a patient can include receiving a patient, such as to allow a medical professional to prescribe a treatment regimen for the patient presenting with at least one of a symptom of an eye condition or a risk factor associated with the eye condition.

VARIOUS NOTES

[00389] The above description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

[00390] In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls. [00391] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[00392] Geometric terms, such as “parallel”, “perpendicular”, “round”, or “square”, are not intended to require absolute mathematical precision, unless the context indicates otherwise. Instead, such geometric terms allow for variations due to manufacturing or equivalent functions. For example, if an element is described as “round” or “generally round,” a component that is not precisely circular (e.g., one that is slightly oblong or is a many-sided polygon) is still encompassed by this description.

[00393] Method examples described herein can be machine or computer- implemented at least in part. Some examples can include a computer-readable medium or machine-readable medium encoded with instructions operable to configure an electronic device to perform methods as described in the above examples. An implementation of such methods can include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code can include computer readable instructions for performing various methods. The code may form portions of computer program products. Further, in an example, the code can be tangibly stored on one or more volatile, non- transitory, or non-volatile tangible computer-readable media, such as during execution or at other times. Examples of these tangible computer-readable media can include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memories (RAMs), read only memories (ROMs), and the like.

[00394] FIG. 10 shows an example block diagram of an example computing machine 1400 that can be used as control circuitry 140. Methods can be implemented on the control circuitry 140. The control circuitry 140 can include a computing machine 1400 upon which any one or more of the techniques or methods discussed herein can be performed. The machine 1400 may be a local or remote computer, or processing node in an on-the-go (OTG) device such as a smartphone, tablet, or wearable device. The machine 1400 may operate as a standalone device or may be connected (e.g., networked) to other machines. In an example, the machine may be directly coupled or be integrated with the apparatus 100, such as any components of the apparatus 100. It will be understood that when the processor 1402 is coupled directly to the apparatus 100, that some components of machine 1400 can be omitted to provide a lightweight and flexible device (e.g., display device, UI navigation device, etc.). In a networked deployment, the machine 1400 may operate in the capacity of a server machine, a client machine, or both in server-client network environments. In an example, the machine 1400 may act as a peer machine in peer-to-peer (P2P) (or other distributed) network environment. The machine 1400 may be a personal computer (PC), a tablet PC, a set-top box (STB), a personal digital assistant (PDA), a mobile telephone, a web appliance, a network router, switch or bridge, or any machine capable of executing instructions (sequential or otherwise) that specify actions to be taken by that machine. In an example, the machine 1400 can include a purpose-designed circuit, such as a printed circuit board that can execute the functions and methods disclosed throughout this application. Further, while only a single machine is illustrated, the term “machine” can also be taken to include any collection of machines that individually or jointly execute a set (or multiple sets) of instructions to perform any one or more of the methodologies discussed herein, such as cloud computing, software as a service (SaaS), other computer cluster configurations. [00395] Examples, as described herein, may include, or may operate by, logic or a number of components, or mechanisms. Circuitry can include a collection of circuits implemented in tangible entities that include hardware (e.g., simple circuits, gates, logic, etc.). Circuitry membership may be flexible over time and underlying hardware variability. Circuitries include members that may, alone or in combination, perform specified operations when operating. In an example, hardware of the circuitry may be immutably designed to carry out a specific operation (e.g., hardwired). In an example, the hardware of the circuitry may include variably connected physical components (e.g., execution units, transistors, simple circuits, etc.) including a computer readable medium physically modified (e.g., magnetically, electrically, moveable placement of invariant massed particles, etc.) to encode instructions of the specific operation. In connecting the physical components, the underlying electrical properties of a hardware constituent are changed, for example, from an insulator to a conductor or vice versa. The instructions enable embedded hardware (e.g., the execution units or a loading mechanism) to create members of the circuitry in hardware via the variable connections to carry out portions of the specific operation when in operation. Accordingly, the computer readable medium is communicatively coupled to the other components of the circuitry when the device is operating.

In an example, any of the physical components may be used in more than one member of more than one circuitry. For example, under operation, execution units may be used in a first circuit of a first circuitry at one point in time and reused by a second circuit in the first circuitry, or by a third circuit in a second circuitry at a different time.

[00396] Machine (e.g., computer system) 1400 can include a hardware processor 1402 (e.g., a central processing unit (MICROCONTROLLER), a graphics processing unit (GPU), a hardware processor core, or any combination thereof), a main memory 1404 and a static memory 1406, some or all of which may communicate with each other via an interlink (e.g., bus) 1408. The machine 1400 may further include a display unit 1410, an alphanumeric input device 1412 (e.g., a keyboard), and a user interface (UI) navigation device 1414 (e.g., a mouse). In an example, the display unit 1410, input device 1412 and UI navigation device 1414 may be a touch screen display. The machine 1400 may additionally include a storage device (e.g., drive unit) 1416, a signal generation device 1418 (e.g., a speaker), a network interface device 1420, and one or more sensors 1421, such as a global positioning system (GPS) sensor, compass, accelerometer, or other sensor. In an example, sensors 1421, such as including sensors 130, can include wearable, assistive device-based and environmental sensors, as described above. The machine 1400 may include an output controller 1428, such as a serial (e.g., universal serial bus (USB), parallel, or other wired or wireless (e.g., infrared (IR), near field communication (NFC), etc.) connection to communicate or control one or more peripheral devices (e.g., a printer, card reader, etc.).

[00397] The storage device 1416 may include a machine readable medium 1422 on which is stored one or more sets of data structures or instructions 1424 (e.g., software) embodying or utilized by any one or more of the techniques or functions described herein. The instructions 1424 may also reside, completely or at least partially, within the main memory 1404, within static memory 1406, or within the hardware processor 1402 during execution thereof by the machine 1400. In an example, one or any combination of the hardware processor 1402, the main memory 1404, the static memory 1406, or the storage device 1416 may constitute machine readable media.

[00398] While the machine readable medium 1422 is illustrated as a single medium, the term "machine readable medium" may include a single medium or multiple media (e.g., a centralized or distributed database, or associated caches and servers) configured to store the one or more instructions 1424.

[00399] The term “machine readable medium” may include any medium that is capable of storing, encoding, or carrying instructions for execution by the machine 1400 and that cause the machine 1400 to perform any one or more of the techniques of the present disclosure, or that is capable of storing, encoding or carrying data structures used by or associated with such instructions. Non limiting machine readable medium examples may include solid-state memories, and optical and magnetic media. In an example, a massed machine readable medium comprises a machine readable medium with a plurality of particles having invariant (e.g., rest) mass. Accordingly, massed machine-readable media are not transitory propagating signals. Specific examples of massed machine readable media may include: non-volatile memory, such as semiconductor memory devices (e.g., Electrically Programmable Read-Only Memory (EPROM), Electrically Erasable Programmable Read-Only Memory (EEPROM)) and flash memory devices; magnetic disks, such as internal hard disks and removable disks; magneto-optical disks; and CD-ROM and DVD- ROM disks.

[00400] The instructions 1424 may further be transmitted or received over a communications network 1426 using a transmission medium via the network interface device 1420 utilizing any one of a number of transfer protocols (e.g., frame relay, internet protocol (IP), transmission control protocol (TCP), user datagram protocol (UDP), hypertext transfer protocol (HTTP), etc.). Example communication networks may include a local area network (LAN), a wide area network (WAN), a packet data network (e.g., the Internet), mobile telephone networks (e.g., cellular networks), Plain Old Telephone (POTS) networks, and wireless data networks (e.g., Institute of Electrical and Electronics Engineers (IEEE) 802.11 family of standards known as Wi-Fi®, IEEE 802.16 family of standards known as WiMax®), IEEE 802.15.4 family of standards, peer-to-peer (P2P) networks, among others. In an example, the network interface device 1420 may include one or more physical jacks (e.g., Ethernet, coaxial, or phone jacks) or one or more antennas to connect to the communications network 1426. In an example, the network interface device 1420 may include a plurality of antennas to wirelessly communicate using at least one of single-input multiple- output (SIMO), multiple-input multiple-output (MIMO), or multiple-input single-output (MISO) techniques. The term “transmission medium” shall be taken to include any intangible medium that is capable of storing, encoding or carrying instructions for execution by the machine 1400, and includes digital or analog communications signals or other intangible medium to facilitate communication of such software

[00401] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to comply with 37 C.F.R. § 1.72(b), to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.