SYSTEMS AND METHODS FOR PHOTOBIOMODULATION OF TARGET TISSUE THROUGH A WINDOW

Cross-Reference to Related Applications

[0001] This application claims the benefit of U.S. Provisional Application No. 63/444,356, filed 9 February 2023, entitled SYSTEMS AND METHODS FOR PHOTOBIOMODULATION OF TARGET TISSUE THROUGH A WINDOW and U.S. Provisional Application No. 63/391 ,837, filed 25 July 2022, entitled CRANIAL WINDOW AND ASSOCIATED SYSTEMS AND METHODS. These provisional applications are hereby incorporated by reference in their entirety for all purposes.

Technical Field

[0002] This disclosure relates generally to photobiomodulation (PBM) and more specifically to systems and methods that deliver light of PBM to a target tissue of a patient through a window created in obstructing material between skin and the target tissue in a closed loop to control dosing of the light for PBM.

Background

[0003] Photobiomodulation (PBM) refers to the delivery of light at prescribed wavelengths and dosing schemes to achieve a desired physiological response (e.g., stimulating healing, enhancing neuroprotection, countering apoptosis, increasing mitochondrial function, improving blood flow, modulating microglial state, decreasing inflammation, etc.). However, delivering light to various parts of the body, such as the brain, for PBM has several challenges. PBM delivery using external systems has limited range and efficacy because the light cannot effectively penetrate light obstructive material (e.g., bone or the like) to reach target tissue. However, significant amounts of light can generally pass through skin.

[0004] Implantable PBM systems can deliver light to a target area from underneath the obstructive material (e.g., the PBM system is implanted between the obstructive material and the target area). However, implanted PBM systems contain an implanted energy source and are costly due to the sophisticated hermetic active electronics technologies employed, not amenable to simple surgeries (e.g., may require stereotactic surgery), require complete replacement if the energy source fails during the patient’s life, and offer limited use models because energy is limited to the capability of the implantable device. Accordingly, PBM delivery to the target area using external systems is preferable, but the light delivered becomes attenuated by any obstructive material, limiting utility of these external systems in many cases. Additionally, it is difficult to estimate the amount of PBM reaching the target area through the obstructive material, so parameters of the light signal indicative of dosing become difficult to set.

Summary

[0005] Described herein are systems and methods that deliver photobiomodulation (PBM) to a subcutaneous target tissue (in a target area) through skin and a window in a closed loop manner to better control PBM dosing. The window can be created through obstructive material (e.g., bone or the like) lying between the skin and the target tissue. The light is generally attenuated by the obstructive material, the window allows the light to be delivered (with less attenuation) to the target area. For example, an external system can be used to deliver light through the skin, which passes through the window (that removes the problems caused by the obstructive material), until reaching the target area, and a component associated with the window can report the dosing to a controller that can set the timing and other parameters of the next dose.

[0006] In an aspect, the present disclosure can include a system that can deliver PBM to a subcutaneous target tissue through a window created in a subcutaneous obstructive material. The window can be configured to be implanted in a location under a patient’s skin to span through obstructive material between the patient’s skin and a target tissue of the patient. The window can include a unique ID to identify the window and at least one data return element to engage in closed-loop control. The system can also include a controller that can be configured to receive the unique ID from the window and set parameters for a light signal to be delivered to the target tissue of the patient based on the unique ID. The controller can be configured to receive feedback data from the at least one data return element and update the parameters based on the feedback data. The system can also include a PBM applicator configured to be positioned externally to the patient’s body above the window and to align with the window to deliver the light signal comprising the parameters transcutaneously through the patient’s skin and through the window to the target tissue of the patient.

[0007] In a further aspect, the present disclosure can include a method for delivering PBM to a subcutaneous target tissue through a window created in a subcutaneous obstructive material. The method can be performed by a controller comprising a processor. The method can include receiving a unique ID from a window located under a patient’s skin and spanning through obstructive material between the patient’s skin and a target tissue of the patient; identifying the window based on the unique ID; and determining parameters for a light signal to be to be sent to a PBM delivery device and applied to the target tissue of the patient based on the unique ID.

[0008] In another aspect, the present disclosure can include a system that can deliver PBM in a closed-loop manner to treat a brain disorder (or injury). The system can include a window configured to be implanted in a location under a patient’s skin to span through obstructive material between the patient’s skin and a target tissue of the patient. The system can also include a controller configured to set parameters for a light signal to be delivered to the target tissue of the patient based on the target tissue of the patient. The system can also include a PBM applicator configured to be positioned externally to the patient’s body above the window and to align with the window to deliver the light signal transcutaneously through the patient’s skin and through the window to the target tissue of the patient. The controller can use a feedback signal from the window to configure the light signal.

[0009] In a further aspect, the present disclosure can include a method for delivering PBM in a closed-loop manner to treat a brain disorder (or injury). The method includes implanting a window in a location under a patient’s skin to span through obstructive material between the patient’s skin and a target tissue of the patient; and delivering a light signal to a target area of the brain, through the patient’s skin and the window. The light signal can be configured to treat the brain disorder (or injury). A controller can use a feedback signal from the window to configure the light signal.

Brief Description of the Drawings

[0010] The foregoing and other features of the present disclosure will become apparent to those skilled in the art to which the present disclosure relates upon reading the following description with reference to the accompanying drawings, in which:

[0011] FIG. 1 is a block diagram showing the way a light signal of photobiomodulation (PBM) is traditionally delivered transcutaneously and how the light signal is hindered by obstructive tissue according to the prior art;

[0012] FIG. 2 is a block diagram showing how the light signal of PBM can be delivered transcutaneously through a window in obstructive tissue to the target area, according to an aspect;

[0013] FIG. 3 is a block diagram showing how the delivery of PBM (e.g., via the system of FIG. 2) can be monitored with a hardware component and according to a feedback signal;

[0014] FIG. 4 is a block diagram showing an example of the hardware component of FIG. 3 being split into different parts;

[0015] FIG. 5 is a block diagram showing an example of how the light signal of PBM (e.g., with an iteration of the system of FIG. 2) can be delivered to a remote target area;

[0016] FIG. 6 is an example front view of the window of FIG. 2 with an outer flange;

[0017] FIG. 7 includes example top view illustrations of differently shaped outer flanges of FIG. 6;

[0018] FIG. 8 shows example top view illustrations of alignment mechanisms that can be part of the differently shaped outer flanges of FIG. 7;

[0019] FIG. 9 shows an example of the PBM applicator using one or more magnets to align with the window for the transcutaneous delivery of the light signal through the window of FIG. 2;

[0020] FIG. 10 is a process flow diagram of a method for placing a window through one or more obstructive materials in a patient’s body;

[0021] FIG. 11 is a process flow diagram of a method for delivering the light signal of PBM according to a unique ID;

[0022] FIG. 12 is a process flow diagram of a method for delivering the light signal of PBM to target tissue according to feedback; and

[0023] FIG. 13 is a process flow diagram of a method for delivering a reconfigured light signal of PBM according to feedback. Detailed Description

I. Definitions

[0024] Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present disclosure pertains.

[0025] As used herein, the singular forms “a,” “an,” and “the” can also include the plural forms, unless the context clearly indicates otherwise.

[0026] As used herein, the terms “comprises” and/or “comprising,” can specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups.

[0027] As used herein, the term “and/or” can include any and all combinations of one or more of the associated listed items.

[0028] As used herein, the terms “first,” “second,” etc. should not limit the elements being described by these terms. These terms are only used to distinguish one element from another. Thus, a “first” element discussed below could also be termed a “second” element without departing from the teachings of the present disclosure. The sequence of operations (or acts/steps) is not limited to the order presented in the claims or figures unless specifically indicated otherwise.

[0029] As used herein, the terms “photobiomodulation” and “PBM” can refer to the delivery of light at one or more prescribed wavelengths and dosing schemes to a predefined target area to achieve a desired physiological response (e.g., to treat at least one physiological condition). The light can be delivered by an external light source (located outside the body) to an internal target area (located within the body); obstructive material can exist between the external light source and the internal target area.

[0030] As used herein, the term “obstructive material” can refer to any material, organic or inorganic, that blocks or otherwise hinders light delivery (e.g., by attenuating, refracting, resisting, etc.). Bone is an example of an obstructive material. It should be understood that the terms “obstructive material” and “obstructive tissue” can be used interchangeably herein. “Obstructive tissue” is meant to have the broad definition of “obstructive material” unless specifically mentioned otherwise. [0031] As used herein, the term “window” can refer to an implant into and/or through obstructive material (e.g., through an opening in the obstructive material that may be pre-existing due to an accident and/or surgically created) that can allow the light to pass through the obstructive material. The implant can include at least a substantially transparent portion (e.g., light transmission element) to transmit light through the obstructive material and may include one or more components to enhance the transmission of light (e.g., one or more materials and/or components that facilitate conveyance of the light therapy through the window to the target tissue to enable/enhance an effect of the PBM on the target tissue). The window can also include one or more hardware and/or communication mechanisms (e.g., hardware component, feedback component, and/or data return element to facilitate closed-loop delivery of PBM), and the like. Each window can be associated with one or more unique IDs identifying the window, the target area, the patient, one or more elements of the prescription for the PBM, or the like.

[0032] As used herein, the term “dosing scheme” can refer to a schedule of one or more quantities of light of one or more wavelengths (doses of PBM) to be delivered to a target area of a patient per unit of time to treat the patient. A dosing scheme can include a time between doses, a time when the dose is to be given, a target light intensity to reach the target area, a luminance of the light, a power associated with the light source, an amount of PBM in the dose to reach the target area, or the like.

[0033] As used herein, the term “subcutaneous” can refer to something being beneath (under) a patient’s skin (e.g., something located subcutaneously is located within the patient's body under the skin).

[0034] As used herein, the term “transcutaneous” can refer to something being through the patient’s skin without disrupting the skin (e.g., light can be delivered transcutaneously from an external light source to an internal target area or a device passing through the patient’s skin). In some instances, transcutaneous may refer to a light source located above the skin delivering light through the skin to a window located (“minimally invasively”) through at least a portion of obstructive material to an internal target area (wherein the obstructive material can be between the internal target area and the light source). [0035] As used herein, the term “light pipe” can refer to a mechanism that can transmit light lengthwise. Non-limiting examples of a light pipe can include optical fibers, transparent plastic rods, and the like. In some instances, light pipes can be coupled to one or more waveguides. In other instances, one or more waveguides may be used to facilitate light transmission without the light pipe. The light pipe and/or waveguide can increase the amount of light conveyed to a target, especially a distant target.

[0036] As used herein, the term “patient” can refer to any warm-blooded organism, including, but not limited to, a human being, a pig, a rat, a mouse, a dog, a cat, a goat, a sheep, a horse, a monkey, an ape, a rabbit, a cow, etc. The terms patient and subject can be used interchangeably herein.

[0037] As used herein, the terms “target tissue”, “target area”, and the like, can be used interchangeably herein to refer to a portion of a patient’s body chosen to receive one or more doses of PBM according to the dosing scheme to treat a pathology. Different target areas may be of differing sizes, depths, locations, and/or cell compositions, which can be treated with different wavelengths and dosing schemes depending on the pathology to be treated.

II. Overview

[0038] Photobiomodulation (PBM) is an attractive solution for treating pathologies of target area (e.g., tissue within a patient’s body) but PBM has not achieved widespread usage because of challenges associated with delivering light to certain target areas. The light of PBM can be delivered using one or more external (and/or minimally invasive) light sources (e.g., percutaneous or transcutaneous delivery of the light) or implanted (invasive) light sources (for subcutaneous and subobstructive material application of the light). Implanted light sources underneath obstructive material(s) have inherent complexities (e.g., costly, requires surgery, limited lifespan, poor power use, etc.) that make these implanted light sources less preferable to external light sources that have fewer complexities. However, external light sources have a limited range and efficacy. As shown in FIG. 1 , the majority of light delivered by an external PBM applicator 104 of system 100, having parameters of the light determined by the controller 102 (including a processor and/or non- transitory memory), in a traditional setting is unable to effectively penetrate obstructive material (e.g., bone of a skull, bone of a sternum, bone of a spine, or the like). The inability of the light to penetrate the obstructive tissue due to attenuation, for example, is shown by the pattern of the light changing from dashed to dotted within the obstructive material and the arrow stopping within the obstructive material. Thus, the target area does not receive a portion and/or any of the amount of light prescribed and the efficacy of treatment is severely diminished. Moreover, it is nearly impossible to estimate the amount of light lost to the obstructive material and/or the amount of light actually delivered to the target area by an external PBM system.

[0039] As shown in FIG. 2, a system 200 can include a window 206 that can be created and/or implanted in at least a portion of the obstructive material above (and in line with) at least a portion of the target area. Generally, the obstructive material lies between the skin and the target area and is an obstacle that light cannot effectively penetrate, travel through, etc. The window allows light to be delivered to the target area and to pass only through the skin and the window before it reaches the target area. As shown in FIG. 2, the light delivered through the window 206 does not suffer from the inability to penetrate the obstructive tissue of prior external solutions (e.g., shown in FIG. 1). The window 206 removes the obstructive tissue, allowing substantially more transcutaneously-applied light to reach the target area. This remains true even if the skin remains intact between the window and the PBM applicator 104 because skin is not considered an obstructive material. In some instances, the window 206 can even include one or more components that can be used in a closed loop manner (e.g., by controller 102) to track and/or adjust the light signal applied to the target area with respect to the dosing scheme to better control dosing of the PBM.

III. Systems

[0040] Photobiomodulation (PBM) generally refers to the delivery of light, at prescribed wavelengths and dosing schemes (e.g., amounts per time), to a target area to achieve a desired physiological response. The target area can include, for example, central nervous system tissue, peripheral nervous system tissue, respiratory tissue, pulmonary tissue, cardiac tissue, cardiorespiratory tissue, or the like. PBM is an attractive treatment solution for many pathologies. For example, PBM may be a possible treatment for brain pathologies and/or injuries that are noted for having limited available and/or effective treatments, including, but not limited to, traumatic brain injury, stroke, global ischemia, Alzheimer’s disease, Parkinson’s disease, Huntington’s disease, depression, anxiety, post-traumatic stress disorder, autism spectrum disorders, and the like. PBM may be used as a treatment for other injuries or disorders, including, but not limited to, healing from spinal cord injury and/or peripheral nerve damage, pain syndromes, osteoarthritis, rheumatoid arthritis, psoriatic arthritis, or the like. PBM also may be used as a treatment for cardiac pathologies and/or injuries, including, but not limited to cardiac ischemia and related disorders, post cardiac infarct healing, cardiac inflammatory disease, myocarditis, inflammation secondary to infection, to vaccine-induced immune response, or to auto-immune disease, or the like. Additionally, PBM may be used as a possible treatment for pulmonary pathologies, including, but not limited to, pulmonary fibrosis (including idiopathic pulmonary fibrosis), chronic obstructive pulmonary disease such as emphysema, bronchitis, or the like. It should be understood that PBM can be delivered to different target areas at the same or different wavelengths and dosing schemes as treatment for the same or different pathologies using the same or different PBM applicator and/or window.

[0041] To treat each such pathology using PBM, a light signal can be applied internally (invasively, not shown) or externally (non-invasively or minimally- invasively, see, e.g., FIG. 1 ). Due to many underlying drawbacks of internal (invasive) delivery, a clear preference exists for external delivery that is non-invasive or only minimally invasive. Generally, the skin is not considered a significant obstruction for light to pass through, so the light source(s) (e.g., the PBM applicator 104 including one or more light sources) can be external to the body (as shown, e.g., in FIGS. 1 -5). When PBM is delivered externally, the light signal (e.g., configured by controller 102 of FIGS. 1-5) is applied from a light source (e.g., a component of PBM applicator 104 of FIGS. 1 -5) to a target area (which is subcutaneous). In the instances described herein the target area can also be under at least one obstructive material and/or tissue (e.g., bone, muscle, a man-made component such as a plate, etc.) .

[0042] As noted, PBM can be externally delivered by at least a controller 102 and a PBM applicator 104. The controller 102 (including a non-transitory memory and/or processor) can be configured to set at least one parameter (e.g., intensity, wavelength, time of application, duration of application, etc.) for a light signal to be delivered to at least a portion of the target area of the patient. A light source (e.g., one or more LEDs, etc.) of the PBM applicator 104 can be configured to deliver the light signal to the target area (often transcutaneously through the patient’s skin based on the position of the light source portion of the PBM applicator 104). In some instances, the PBM applicator 104 and/or the controller 102 can include one or more indicators (either physical indicators (e.g., visual, auditory, and/or tactile) and/or indicators/flags that are shown on a display), such as an ON/OFF indicator, a charge status indicator, a fault status indicator (e.g., indicating the one or more components of the system is not working), a dosage scheme indicator (e.g., indicating a dose is needed, where the patient is in the dosage scheme, etc.), or the like.

[0043] Although illustrated in FIGS. 1 -5 as single, independent devices, it should be noted that each of the controller 102 and/or the PBM applicator 104 can, in some instances include a plurality of devices. In other instances, although illustrated as separate devices in FIGS. 1 -5, at least a portion of the PBM applicator 104 can be a part of at least a portion of the controller 102 (in other words, at least a portion of the PBM applicator 104 and at least a portion of the controller 102 can be a common device in a common housing or sharing common components). While the controller 102 generally can be completely external to the body, the PBM applicator 104 can be fully external to the patient’s body, as illustrated, or at least partially internal to the patient’s body (e.g., under the patient’s skin). It should be noted that the PBM applicator 104 can include a light source portion and circuitry to control the light source portion. The light source portion of the PBM applicator 104 can be minimally invasively hermetically implanted positioned beneath the skin but above obstructive material (which still lies between the light source and the target area), while the rest of the PBM applicator 104 (e.g., circuitry) can be external to the patient’s body. However, the light source portion of the PBM applicator 104 can be placed above the skin to deliver the light signal. While the PBM applicator 104 is illustrated as contacting the external side of the skin, it should be understood that the PBM applicator 104 may be held a distance above the skin or minimally invasively implanted under the skin. The light source can include one or more light sources, such as one or more LEDs capable of generating one or more light signals of one or more wavelengths. Additionally, as shown in FIGS. 1 -5, the PBM applicator 104 may provide feedback to the controller 102 about the light being provided externally (e.g., wavelength, duration, etc.). This feedback cannot provide information about the amount of light being delivered to/received by the target area.

[0044] An obstructive material often lies between the skin and the target area. As shown in FIG. 1 , the obstructive material stops at least a portion of the light from passing through to the target area. Examples of the obstructive material can include tissues such as bone (e.g., bone of a skull, bone of a sternum, bone of a spine, etc.), muscle, fat, or the like and/or foreign objects such as metal plates or other surgically implanted materials. Although the skin generally is not considered a significant obstruction for light to pass through, the skin can provide a small level of obstruction of light, which can be detrimental to dosage schemes of PBM that deliver smaller amounts of light (e.g., the level of the light obstruction of the skin may be on the scale of or significantly impact the delivery of the smaller dosage) (in these situations, the light source of the PBM applicator 104 can be minimally invasively implanted under the skin). Light cannot effectively pass through the obstructive material (e.g., due to attenuation, refraction, resistance, etc.), as shown in FIG. 1 (light dashes turning to dots in the obstructive material and the arrows stopping in the obstructive material). It should be noted that, in the drawings, components of the systems are associated with element numbers, while parts of the body (e.g., skin, obstructive material, target area) are not numbered.

[0045] It should be noted that the absorption coefficient for skin may not always be dramatically different than other tissues, but the skin is usually thinner than traditional obstructive material (e.g., bone). Bone, on the other hand, in contrast. Can be quite thick - often from 5 to 11 mm, and the inside of some bone is full of blood rich marrow. While skin does contribute to light attenuation, and the contribution is not always insignificant, removal of the bone will significantly reduce the attenuation and enable a greater amount of light to get into the target tissue than otherwise.

[0046] As noted, the general case illustrated in FIGS. 1 -5 shows the obstructive material positioned between the skin and the target area, however the obstructive material may be in any position relative to the skin, target area, and PBM applicator. The obstructive material generally is a barrier to at least a portion of the light signal delivered by the PBM applicator 104. Removing a portion of the obstructive material removes an obstacle for the light signal to reach the target tissue (e.g., an obstacle that can hinder, attenuate, refract, resist, or the like, an amount of the light before it reaches the intended target tissue/area). As shown in FIG. 2 (and FIGS. 3-5), a window 206 can be placed within and through at least a portion of the obstructive material in a space that spans through the obstructive material at a predetermined location (e.g., in line with at least a portion of the target area, in line with one or more physiological landmarks, on a line between at least a portion of the light source of the PBM applicator 104 and the at least a portion of the target area, or the like). The window 206 can at least partially include at least one of gas, liquid, glass, crystal, a non-material empty space like a vacuum, or any sufficiently light transmissive material for light to pass through. The window 206 may include an outer housing and/or flanges (examples shown in FIGS. 6-8) for positioning in the obstructive material and/or positioning/aligning with respect to the PBM applicator 104 (example shown in FIG. 9). In some instances, the window 206 can Include no active electronic components (e.g., shown in FIG. 2) or passive electronic components (e.g., electrodes under the skin or on top of the window receive current from electrodes on the outside of the skin). In other instances, the window 206 can include active electronic components (e.g., one or more electronic components configured to receive external power) described in further detail with respect to FIGS. 3-5.

[0047] At the predetermined location, a hole through at least a part of the obstructive material can be pre-existing (e.g., based on a prior accident or a prior surgical intervention) or can be created in the obstructive material (e.g., surgically) and the window 206 can be placed within the hole. The window 206 is a device that can span through the hole. The window 206 can include a substantially clear material (e.g., glass, crystal, liquid, gas, a non-material empty space like a vacuum, etc.) for transmitting light and may include additional components and/or materials for treatment and/or positioning purposes. By spanning through the hole, the window 206 can allow a greater amount of light to pass from the light source of the PBM applicator 104 to at least a portion of the target area (as compared to if the light had to pass through the obstructive material). By replacing a portion of the obstructive material, the substantially clear material of the window 206 can remove an obstacle for the light signal and allow a greater amount of the light signal to pass from the light source of the PBM applicator 104 to the target area. [0048] The window 206 can extend through the obstructive material without contacting and/or penetrating the target area. Although the window 206, the obstructive material, the skin, and the target area are illustrated as being separated from each other by at least one distance (e.g., as shown in FIGS. 2-5); however, this is simply for ease of illustration. It should be understood that the distances can each be any number from zero (e.g., touching/contiguous with at least one of each other) to a gap of about 200 mm, or more, depending on one or more materials of the window 206, dimensions of the window, tissue regrowth, positioning of the window, location of the target area, etc. In some instances, the target area may be a further distance from the obstructive tissue and the window 206 and a light pipe and/or waveguide may be part of the system for transmitting the light signal to the target area, as described in further detail with regard to FIG. 5. The window 206 can improve the amount of light delivered with PBM to target areas that are traditionally blocked by obstructive material. Non-limiting examples of such therapeutic targets include light being applied to the surface of the brain, light being delivered inside the brain, light being delivered to the spinal cord, light being delivered to a lung, light being delivered to cardiac tissue, light being delivered to cardiorespiratory tissue, or the like. As an example, the window 206 can penetrate obstructive bone without contacting or penetrating the brain, the spinal cord, the lung, the heart, or the like. [0049] The window 206 can be a permanent implantation. The window 206 can also be temporary and removeable (e.g., the obstructive material may be allowed to heal - partially or completely - after removal of the window 206 to fill the hole or the hole may exist forever). For example, at least a portion of the window 206 can include a bioresorbable material that starts to bioresorb after a time duration. For example, the window 206 can be bioresorbable to enable conveyance of an amount of light for a finite, predefined period of time (e.g., based on one or more properties of the bioresorbable material, where the bioresorbable material can be chosen based on the therapeutic application). In some instances, the window 206 can hold one or more drugs (e.g., in one or more reservoirs, in a substrate matrix, or the like) and can deliver the one or more drugs to the target area or tissue near the target area before, concurrent with, and/or after delivery of the light signal to the target area for additional therapeutic effect. In other instances, the controller 102 can signal another device (not shown) to deliver a drug to the patient (e.g., to a location not in or near the target area) before, concurrent with, and/or after delivery of the light signal to the target area.

[0050] The window 206 is shown with a rectangular front side in FIGS. 1 -5 but can be of any three dimensional shape configured to span through the obstructive material and transmit light to at least a portion of the target area (does not necessarily need to fill the entire width, depth, and/or height of the hole in the obstructive material). In some instances (e.g., to simplify the implant procedure), the window 206 can have a generally round cross section and a cylindrical length (e.g., as shown in FIG. 6). When the window 206 has a generally round cross section, the implant procedure can include drilling a hole in the obstructive material to create a space and placing the window 206 in the space. When the cross section of the window 206 is a round cylinder, the window 206 can fill at least a portion of the hole drilled through the obstructive material. For example, a cross section of the window 206 can have a diameter less than or equal to a diameter of the hole. The drill can have a diameter the same as, or about the same as, a typical burr hole drill (and thus require no new equipment for a surgeon to place). Typical sized diameters for the hole and window 206 can be, for example, 9 mm, 11 mm, 14 mm, 16 mm, 22 mm, 25 mm, and the like. As an example, the inside boundary of the window 206 can be reflective so that light that is inside the window can continue through the window instead of being absorbed by the window when light hits the inside boundary.

[0051] As shown in FIG. 6, in some aspects, the window 206 can include an outer flange 602. The outer flange 602 can at least one of secure the window in place at the implanted location and improve a fit of the window in the implanted location (hole). The outer flange 602 can, additionally or alternatively, include feature for securing the assembly to bone (e.g., holes so that screws, like titanium screws, can secure the window to a portion of the skull or other bone). The outer flange 602 can be a flat rim, collar, or rib extending from a portion of the window 206. While shown in FIG. 6 as having a cylindrical shape with the cross section including a concentric cut out for the window 206 to span through and protrude from one side, the outer flange 602 can have a cross section and/or profile in any shape. Different example layouts of the outer flange 602 are shown in FIG. 7 as 602A (outer flange having a circular cross section), 602B (outer flange having a triangular cross section), 602C (outer flange comprising a plurality (3) protruding arms). It should be understood that the example layouts in FIGS. 6 and 7 are non-exhaustive and not intended to be limiting.

[0052] The PBM applicator 104 can be positioned above the window 206 (e.g., shown in FIG. 9) and configured to align with the window 206 such that at least one light source of the PBM applicator 104 is aligned with at least a portion of the window 206. The PBM applicator 104 can be aligned with the window 206 mechanically, magnetically, or the like. The mechanical alignment can be based on a mechanical mechanism within the window 206 and/or the PBM applicator 104. The magnetic alignment can be based on at least one ferromagnetic material on one side of the skin and a magnet on the other (opposite) side of the skin. For example, at least a portion of the window 206 can include a ferromagnetic material and at least a portion of the PBM applicator 104 can include a magnet. As another example, at least a portion of the PBM applicator 104 can include a ferromagnetic material and at least a portion of the window 206 can include a magnet. As a further example magnets can be on both sides of the skin with the N and S poles arranged to facilitate alignment. As shown in FIG. 8, if the window 206 also includes an outer flange 602A, 602B, 602C, then the ferromagnetic material or the magnet 802 (depending on if the PBM applicator includes a magnet or ferromagnetic material, respectively) can be positioned in at least a portion of the flange. Different exemplary layouts of the ferromagnet material or magnet 802 on examples the outer flange 602A, 602B, 602C are shown in FIG. 8 (e.g., ferromagnetic material or magnetic ring 802A in outer flange 602A, multiple discrete instances of ferromagnetic material or magnets 802B in outer flange 602B, and one instance of ferromagnetic material or magnet 802C per arm of outer flange 602C. It should be understood that the example layouts in FIG. 8 are non-exhaustive and not intended to be limiting. As shown in FIG. 9, a ferromagnetic material and or magnet 904 in the PBM applicator 104 can magnetically align with a ferromagnetic material or magnet 802 in the window 206 via properties of magnetism (e.g., ferromagnetic material aligns with magnet).

[0053] Referring again to FIGS. 2-5, the window 206 can include the substantially transparent material and one or more additional materials/components that facilitate transmission of the light through the window 206. As shown in system 200 of FIG. 2 there can be no feedback from the window 206 to the controller 102 in some instances. In all instances the controller 102 can send at least configuration details (e.g., configurations of the parameters of the light signal) to the PBM applicator 104. In some instances, the PBM applicator 104 may send feedback data (e.g., information about the state of the PBM applicator, information about the patient, information about the window, the unique ID of the window, etc.) to the controller 102. The controller 102 and the PBM applicator 104 can communicate via a wired and/or a wireless connection (e.g., Wi-Fi, Bluetooth, etc.). FIG. 3-5 show examples of feedback sent from the window 206 to the controller 102, such that the controller can improve delivery of the light signal of the PBM to the target area. The window 206, the controller 102, and/or the PBM applicator 104 can be in at least one of wired communication, wireless communication, or optical communication. For example, the feedback sent from the window 206 and received by the controller 102 can include information (data signal or other type of signal) about light received by the window, transmitted through the window, exiting the window, or the like. The feedback can allow the controller 102 to configure and/or reconfigure the parameters (e.g., intensity, wavelength, time of application, duration of application, etc.) of the light signal of the PBM more precisely so that the light signal delivered to the target area matches the prescription. As an example, the feedback can be embodied as light reflected back to the controller 102 and/or the PBM applicator (wherein the controller and/or the PBM applicator can further include a photodetector to detect at least one property of the reflected light).

[0054] In FIGS. 2-5, the window 206 can include one or more materials that facilitate conveyance of the light therapy through the window to the target area of the patient to enable an effect of the PBM on the target area of the patient. As shown in system 500 FIG. 5, the window 206 can also include at least a portion of at least one optical feature (also referred to as a lens component) L 412 to reflect, focus, and/or spread the light signal before delivery to the target area of the patient. The optical feature L 412 can include a mirror, a lens, a diffusor, or the like, arranged based on the ultimate function desired. As an example, the optical feature L 412 can be a flat lens, such as a GRIN lens, or a non-flat lens, such as a Fresnel lens, which can focus the light. The flat lens can focus the light on a specific tissue region (e.g., within the target area, similar to what is shown in FIGS. 2-4) or to a light pipe 406 (and/or waveguide) (shown in FIG. 5) connected to or in communication with the window 206 to deliver the light signal of the PBM applicator 104 to the target area for transmission to the target area. The non-flat lens, such as the Fresnel lens, has a possible advantage of using simpler materials even though the non-flat lens has a non-flat surface. The window 206 may, additionally or alternatively, include a metamaterial (one or more of a class of artificial materials that can achieve electromagnetic properties that do not occur naturally, such as negative index of refraction or electromagnetic cloaking) to focus or spread the light and can be selected based on tissue properties within the target area and whether focusing or spreading is preferred. The metamaterial, in some instances, can be chosen based on tissue properties discovered based on preoperative imaging of the target area. [0055] As shown in system 300-500 of FIGS. 3-5, the window 206 can receive light from the light source (e.g., one or more light sources as are known in the art) of the PBM applicator 104 that has been configured by the controller 102 and send feedback (e.g., by hardware, H 310) to the controller 102 including an indication of the light transmitted to the target area. The indication of the light transmitted to the target area may be determined by direct measurement (e.g., if the hardware component (H 310 or H1 -A310-A and H-B 310-B) is positioned near and/or in at least a portion of the target area) or indirect measurement (e.g., if the hardware component is positioned in/on at least a portion of the window 206) by taking the total light delivered from the PBM applicator 104 and subtracting at least the amount of the light reflected or absorbed by the hardware component. The controller 102 and/or any circuitry related to/within the one or more hardware components (e.g., H 310) of the window 206 can relate the reflection or absorption of light in the hardware component to an amount of light delivered to the target area (e.g., the amount of light by the top of the window, transmitted through the window , or delivered to the target area after traveling through the window can be related to the amount of light delivered to the target area) and provide data. The light throughput through the window 206 to the target area can be estimated by the controller 102 based on the feedback (e.g., data, a reflected light signal, etc.).

[0056] The feedback data, or other data, from the window 206 and/or the hardware component (e.g., H 310, H-A 310-A, and/or H-B 310-b) can, additionally or alternatively, include, but is not limited to, information about the window (e.g., dimensions, materials, etc.), information about the patient (e.g., age, gender, condition, medical notes, prescription information, etc.), information indicating an alignment of the light source of the PBM applicator 104 and the window (e.g., direct alignment, partial alignment, etc.), or the like. For example, at least a portion of data can be submitted to the controller 102 before the first transmission of the light signal from the PBM applicator 104. The controller 102 can monitor the amount, intensity, direction, duration, time of application, etc., of the light signal based on a feedback signal and can adjust the configuration of at least one parameter (e.g., wavelength, intensity, time of application, duration of application, pulsed/solid, etc.) of the light signal being generated by the PBM applicator 104 according to the feedback signal received. As such, the window 206 and the controller 102 can be a closed loop system that can ensure that a certain PBM dosage profile has been delivered to the target area. However, it should be understood that the controller 102, in other instances, can be an open loop system (e.g., user in the loop) where at least a portion of the data is presented to a user who makes adjustments to the controller 102 based on the data. The controller 102, in some instances, can be programmed with a prescription for the PBM dosage profile (e.g., light intensities wavelengths, times of application, lengths of light application, types of light application, etc.). In some instances, the prescription can include a finite number of doses and a prescription to deliver the finite number of doses at specified times, after which the patient must see a clinician, talk to a clinician, etc., to receive a refill, a new prescription, or the like. The feedback can be used to affect the dosing signal, for example, if it is determined not enough light is reaching the target area at a time then the light can be made more intense, applied for a longer time, etc. or if the wrong wavelengths are detected then the wavelength of the light being applied can change, or if the light signal being applied is too intense then the controller can decrease the intensity.

[0057] Upon receiving the light one or more hardware components (an example represented as H 310, H-A 310-A, and H-B 310-B) can record information related to an amount of the light received by the window 206 and/or transmitted to the target area. In some instances, one or more of the hardware components can be within and/or on the window 206 (like H 310 or H-A 310-A). For example, a hardware component that can be part of the window 206 (or implanted within the window) (like H 310 or H-A 310-A) can be a reflective entity (e.g., a mirror). In other instances, one or more hardware components (like H 310-B) can be implanted into a different location (illustrated in FIG. 5), such as a subcutaneous location, between the obstructive material and the skin or between the window 206 and the skin. The hardware component (like H-B 310-B) can include elements to electrically communicate with the window 206 (e.g., via the hardware component H-A 310-A, or via circuitry), the PBM applicator 104 and/or the controller 102. For example, the hardware component (e.g., H-B 310-B) can include one or more circuit elements (such as a transmitter, receiver, or transceiver) that may be hermetically sealed within the hardware component. In still other instances, the window 206 can include one or more hardware components that are within/on the window (like H-A 310-A) and one or more hardware components that are implanted into a different location (like H-B 310-B); in this example, at least a portion of each of the hardware components can be in communication with one another. The one or more hardware components (H-A 310-A and H-B 310-B) can be configured to record/transmit data related to the light received by the window 206. Depending on the position within the window 206 or outside of the window, one or more of the components (H-A 310-A and H-B 310-B) can be configured to record data related to the light received by the top of the window, the light transmitted through at least a portion of the window, or the light delivered to the target area after traveling through the window. As one example, one or more of the components (H-A 310-A and H-B 310-B) can include a photodiode, which can be used generally to measure the amount of light reaching it, or other electronic component within hardware.

[0058] The controller 102 can store one or more such PBM dosage profiles. For example, the controller 102 can store different PBM dosage profiles for different target areas. As an example, a patient may have two different target areas requiring treatment with two different windows (e.g., windows 206) implanted through obstructive material above each target area, and each correspond to a different PBM dosage profile. The initial feedback an include a unique ID of the specific window 206. The controller 102 can identify the specific window 206 based on the unique ID and match the specific window to the correct PBM dosage profile, ensuring that the target area receives the correct PBM dosage.

[0059] As an example, the window 206 and any additional components (e.g., H 310, H-A 310-A, and/or H-B 310-B) can receive a light signal from a light source of PBM applicator 104 (the light signal initially configured by the controller 102 according to a PBM dosage profile) based on the data, send additional data to the controller (regarding the light received by the window ), and receive another light signal from a light source of the PBM applicator with parameters updated based on the additional data received by the controller. The controller 102 can participate in a closed loop with the window 206 and/or any other components shown in FIGS. 2-5) to ensure that the target area receives the prescribed dosage according to the dosage profile. Window 206 can include a light transmission element to receive a light signal and deliver the light signal to the target area (may include components such a L 412 and/or materials described above), a hardware element (e.g., H 310, etc.) that can act as, include, or be coupled to a data return element configured to deliver feedback to the controller 102 and may be embedded in a component associated with the window , including a set up element that sends initial information to the controller (e.g., about the window, the patient, the target area, etc.) and a feedback type hardware element (e.g., H 310) that sends information about the amount of light received by the window 206. Optionally, the window 206 can be associated with a computing element (which may be in a component associated with the window) and may include a unique ID that identifies the specific window 206 (e.g., as unique among all windows, as unique within the windows used by the patient, or the like).

[0060] In a situation where the window 206 has a unique ID, the controller 104 can receive the unique ID from the window 206 and set parameters for a light signal to be delivered to the target tissue of the patient based on the unique ID. After the initial light signal is delivered (by a light source of a PBM applicator 104 aligned with the window), the controller 102 can receive feedback data from the window 206 (e.g., H 310) and update the parameters based on the feedback data.

[0061] As shown in system 500 of FIG. 5, the target area is a further distance from the skin and the obstructive material - generally referred to as “deeper” within the tissue than the obstructive material. A light pipe 406 can extend from one end in contact with or contiguous with at least a portion of the window 206 (e.g., a portion, L 412, with optical elements that focus light toward the light pipe) towards a target area, the other end of the light pipe 406 can extend to contact at least a portion of the target area (as shown) or near but not contacting the target area. The light pipe 406 can transmit light along its length from the window 206 (delivered by the PBM applicator 104) along its length to the deeper target area, which can be, for example, a target area that would not receive a full dose of the light through just the window due to its distance from the window, and/or intervening structures that cannot be moved or removed, etc. As described above, the window 206 can include a lens (as an example of L 412) for directing the light received from the PBM applicator 104 towards the light pipe 406. It should be understood that one or more waveguides can be used with and/or instead of the light pipe 406.

IV. Methods

[0062] Another aspect of the present disclosure can include methods (FIGS. 9- 12) for delivering light of photobiomodulation (PBM) transcutaneously from an external light source (e.g., PBM applicator 104) to a subcutaneous target tissue of a patient. Traditionally, a subcutaneous obstructive material can hinder (e.g., by attenuating, refracting, resisting, etc.) the light signal delivered transcutaneously from reaching the target area. For example, the obstructive tissue can be bone (e.g., within at least one of a skull, a sternum, or a spine), for example, which can attenuate the light signal of the PBM so much that the prescribed amount of light does not reach the target area. Advantageously, the transcutaneous light delivery of the methods 1000-1300 is aided by a subcutaneous window (e.g., window 206 aspects of which are shown in FIGS. 2-9) created in obstructing material between skin and the target tissue. A closed loop with at least a portion of the subcutaneous window can be used by a controller (e.g., controller 102), which defines parameters for the light delivered by the light source (e.g., PBM applicator 104), to regulate the amount of light delivered by the PBM applicator (which, as previously noted, may be within the controller housing) of the light signal of PBM (e.g., change the parameters). For example, the window (e.g., window 206) can include one or more components that can facilitate a feedback signal being transferred to the controller (e.g., controller 102). The feedback can allow the controller (e.g., controller 102) to track the amount of light being received by the target area and to adjust the parameters for the light signal to better match the prescribed amount of light. It should be understood that the controller 102 is described as working in a closed loop, the controller 102 may also work in an open loop (user-in-the-loop) system.

[0063] For purposes of simplicity, the method is shown and described as being executed serially; however, it is to be understood and appreciated that the present disclosure is not limited by the illustrated order as some steps could occur in different orders and/or concurrently with other steps shown and described herein. Moreover, not all illustrated aspects may be required to implement the method, nor is the method necessarily limited to the illustrated aspects.

[0064] Referring now to FIG. 10, illustrated is a method 1000 for delivering PBM to a target tissue of a patient. The target tissue is generally obstructed by other tissues (many of which are “obstructive materials” - particularly bone). A light signal of PBM generally cannot travel through the obstructive material to a target tissue without being hindered or attenuated such that the treatment properties are reduced (e.g., the light signal cannot reach the target area at full strength, if at all) . However, the light signal can travel unhindered or less hindered through a window (e.g., window 206) created in the obstructive material to facilitate reaching the target tissue. The window (e.g., window 206) can also send feedback related to the delivery of the light signal to the target tissue to a controller (e.g., controller 102), so that the controller can reconfigure parameters of the light signal (e.g., time of application, pattern of application, heat of application, etc.) in a closed loop manner. [0065] At 1002, a light signal that is configured to deliver a dose of PBM (e.g., the light signal at a wavelength and an intensity for a time) can be delivered to a target tissue. The light signal can be delivered transcutaneously through a patient’s skin (which is generally not considered an obstructive material or is considered a less-obstructive material) and through the window (e.g., window 206) in an obstructive material to reach the target tissue. The parameters of the light signal for the PBM and/or at least a portion of the dosing scheme of the PBM can be configured by the controller (e.g., controller 102) and then sent to a PBM applicator (e.g., PBM applicator 104) to be delivered to the patient. At 1004, feedback can be received (e.g., by controller 102 from one or more components - e.g., H 310, H-A 310-A, and/or H-B 310B - of window 206) based on delivery of the light signal. For example, the feedback can include the amount of light transmitting through the window. In some instances, the feedback can include a reflection of the light that can be measured by a component (not shown) of the PBM applicator and/or the controller so the controller can determine the amount of light transmitting through the window. In other instances, feedback can be an electrical signal if the component is a photodetector in communication with the controller (which may include a component to actually measure the light/the reflection of the light off the reflective part). At 1006, at least a portion of the feedback can be used (e.g., by controller 102) to reconfigure the light signal (e.g., a parameter of the light signal) to deliver the dose of PBM to the target tissue. For example, at least a portion of the feedback can be used to reconfigure a wavelength, an intensity, a time of application, a type of application, etc. of the light signal. The feedback can also be used to estimate an amount of light being delivered to the target tissue in a dose based on the feedback data, estimate a total amount of light being delivered to the target tissue based on the feedback data, estimate an alignment of the window, or the like. Using the window (e.g., window 206) and the feedback, the controller (e.g., controller 102) can ensure that the correct dose of PBM (e.g., a dose according to a prescription, a therapeutically effective dose, or the like) is being delivered to the target tissue. [0066] FIG. 11 illustrates a method 1100 for placing a window through obstructive tissue in a patient’s body. It should be understood that a plurality of windows can be placed at different locations in the patient’s body through different or the same obstructive tissues in the patient’s body (each window may be identifiable by different unique IDs, for example). At 1102, the window (e.g., window 206) can be implanted in a location under a patient’s skin through at least a portion of obstructive material between the patient’s skin and a target tissue. The window can be implanted without penetrating the target area. The implantation can include, for example making a hole in at least a portion of the obstructive material, using a hole already existing in a portion of the obstructive material (e.g., because of an accident or previous medical intervention), or widening/deepening an already existing hole. The implantation can include incising at least a portion of the skin of the patient. For instance, the window can be implanted so as to span through bone and/or muscle but to not penetrate the dura when located under the patient’s skin near the brain or spinal cord. At 1104, the patient’s skin can be allowed to heal over the window (e.g., window 206). As used herein, the term “over the window” can include an incision near, around, etc., the window. For example, a neurosurgeon can cut a patient’s skin so to create a flap whose edges do not cross over the window, allowing the applicator/window to be used sooner without having to wait for the incision to heal and to avoid having to pass light through scar tissue generated during the healing process. [0067] The skin can heal over the window to lessen the chance of negative implications of the window’s implantation (e.g., surgery related illnesses). As an example, features of the window, like the unique ID, can be stored with the information about the window to identify the window before any treatment is undertaken.

[0068] FIG. 12 illustrates a method 1200 for delivering the light signal of PBM according to a unique ID associated with the window (e.g., window 206). The unique ID can be a number or alphanumeric combination that can be unique for all windows in the world, all windows made by the manufacturer, and/or all windows associated with the user. At 1202, the unique ID can be received (e.g., by controller 102) from a window (e.g., window 206) located under a patient’s skin and spanning through at least a portion of obstructive material between the patient’s skin and a target tissue. The unique ID can be, for example, a radio frequency signal that can be communicated to the controller (e.g., controller 102) via a wireless communication and/or through the PBM applicator (e.g., PBM applicator 104). At 1204, the window can be identified (e.g., by controller 102) based at least in part on the unique ID. For example, the unique ID can be compared with a plurality of unique IDs stored in a database stored in memory on and/or accessible by the controller (e.g., controller 102). At 1206, parameters for a light signal to be delivered to the target tissue for PBM can be determined (by controller 102) based on the unique ID. For example, the parameters for the light signal can be associated with the unique ID in the database as part of a dosing scheme. In another example, the parameters can be determined at least in part based on feedback received for previous applications of the light signal. The parameters for the light signal to be sent to a PBM delivery device and the light signal having those parameters can be applied to the target tissue of the patient based on the unique ID.

[0069] FIG. 13 illustrates a method 1300 for delivering a reconfigured light signal of PBM according to feedback received from an initial application of a light signal. At 1302, feedback (e.g., a feedback signal) can be received (e.g., by controller 102 from window 206) after application of a light signal configured according to original parameters set by the controller. For example, the feedback can include the amount of light transmitting through the window. In some instances, the feedback can include a reflection of the light that can be measured by a component (not shown) of the PBM applicator and/or the controller so the controller can determine the amount of light transmitting through the window. In other instances, feedback can be an electrical signal if the component is a photodetector in communication with the controller (which may include a component to actually measure the light/the reflection of the light off the reflective part). At 1006, at least a portion of the feedback can be used (e.g., by controller 102) to reconfigure the light signal (e.g., a parameter of the light signal) to deliver the dose of PBM to the target tissue. For example, at least a portion of the feedback can be used to reconfigure a wavelength, an intensity, a time of application, a type of application, etc. of the light signal. The feedback can also be used to estimate an amount of light being delivered to the target tissue in a dose based on the feedback data, estimate a total amount of light being delivered to the target tissue based on the feedback data, estimate an alignment of the window, or the like. At 1304, the light signal can be reconfigured (e.g., with different amounts of light delivered according to new parameters set by the controller 102) to ensure that the target tissue receives a predetermined PBM dosage based on at least a portion of the feedback signal. The controller can also take into account estimates of the amount of light that will be transmitted to and/or absorbed by intervening tissues and/or use models of limits or thresholds to determine safe and effective parameters.

[0070] It should be noted that the PBM can be applied at different target tissue areas through either the same or different windows created through obstructive tissues. The window(s) can be driven by a controller that can configure each PBM. Additionally, communication can be established between the controller and the window(s). For example, the communication can include feedback that the controller can use to estimate an amount of light being delivered to the target tissue in a dose, a total amount of light being delivered to the target tissue, and/or alignment of the window, determine the identity of the window based on a unique ID, or the like. [0071] From the above description, those skilled in the art will perceive improvements, changes, and modifications. Such improvements, changes and modifications are within the skill of one in the art and are intended to be covered by the appended claims.