INNER EAR ACCESS SHAPED DEVICES AND METHODS

CROSS-REFERENCE TO RELATED APPLICATIONS

[oooi] This application claims priority to U.S. Provisional Application No. 63/298,442, entitled INNER EAR ACCESS SHAPED DEVICES AND METHODS, filed on January 11, 2022, naming Wolfram Frederik DUECK as an inventor, the entire contents of that application being incorporated herein by reference in its entirety.

BACKGROUND

[oooi] Medical devices have provided a wide range of therapeutic benefits to recipients over recent decades. Medical devices can include internal or implantable components/devices, external or wearable components/devices, or combinations thereof (e.g., a device having an external component communicating with an implantable component). Medical devices, such as traditional hearing aids, partially or fully-implantable hearing prostheses (e.g., bone conduction devices, mechanical stimulators, cochlear implants, etc.), pacemakers, defibrillators, functional electrical stimulation devices, and other medical devices, have been successful in performing lifesaving and/or lifestyle enhancement functions and/or recipient monitoring for a number of years.

[0002] The types of medical devices and the ranges of functions performed thereby have increased over the years. For example, many medical devices, sometimes referred to as “implantable medical devices,” now often include one or more instruments, apparatus, sensors, processors, controllers or other functional mechanical or electrical components that are permanently or temporarily implanted in a recipient. These functional devices are typically used to diagnose, prevent, monitor, treat, or manage a disease/injury or symptom thereof, or to investigate, replace or modify the anatomy or a physiological process. Many of these functional devices utilize power and/or data received from external devices that are part of, or operate in conjunction with, implantable components.

SUMMARY

[0003] In an exemplary embodiment, there is a device, comprising a tissue interface portion configured for securement to tissue of and/or proximate a barrier between a hollow body portion of a human and configured to provide a passage from outside the hollow body portion to inside the hollow body portion, wherein the tissue interface portion has a longitudinal axis, a surface of the tissue interfacing portion that directly interfaces with tissue and/or indirectly interfaces with tissue when the tissue interface portion is secured to the tissue is more normal than parallel to the longitudinal axis, and the surface is located at a distal section of the tissue interface portion.

[0004] In an exemplary embodiment, there is an apparatus, comprising a device including a bone cutting and/or grinding surface, wherein the device includes a hollow passage extending completely from a proximal end of the device to a distal end of the device to the surface, creating an opening in the surface, and the device is a cochleostomy establishment device.

[0005] In an exemplary embodiment, there is a method, comprising obtaining access to a middle ear cavity of a human, removing a quantity of tissue of a barrier between the middle ear and an inner ear cavity of the human and removably permanently fixing a cochlear access port at an area of the removed quantity of tissue, wherein the removed quantity leaves a portion of the barrier intact, with respect to a longitudinal axis of the port treated as being in a vertical direction, directly beneath the area of the removed quantity of tissue, and the port is placed directly above the portion of the barrier that is intact.

[0006] In an exemplary embodiment, there is an inner ear access port, comprising a tissue interface portion, the tissue interface portion including a cylindrical body or cylindrical body portion of a first outer diameter and a cylindrical body or cylindrical body portion of a second outer diameter substantially smaller than the first outer diameter, the first and second outer diameters being concentric with one another, the tissue interface portion being configured for adhesive and/or cement securement to bone of and/or proximate an inner ear of a human, wherein the tissue interface portion has a passage from an interior thereof to an outside thereof, and that passage provides a passage from outside the inner ear to inside the inner ear, the tissue interface portion has a longitudinal axis, a surface of the tissue interfacing portion that directly interfaces with tissue and/or indirectly interfaces with tissue when the tissue interface portion is secured to the tissue is more normal than parallel to the longitudinal axis, and the surface is located at a distal section of the tissue interface portion.

BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Embodiments are described below with reference to the attached drawings, in which:

[0008] FIG. 1 is perspective view of a human ear;

[0009] FIG. 2 is a perspective view of an exemplary cochlear stimulator implanted in accordance with an exemplary embodiment; [ooio] FIGs. 3 and 4 and 4A are schematics depicting exemplary implantable components for background purposes;

[0011] FIG. 5 is a schematic depicting an exemplary therapeutic substance delivery system for background purposes;

[0012] FIG. 6 is a schematic depicting exemplary background working ends of an embodiment that combines the embodiments of FIGs. 3 to 5.

[0013] FIGs. 8, 9 and 10 depict exemplary ports separate from the invention but which have some features of which embodiments of the present invention can use;

[0014] FIGs. 7, 11-17B and 24-26 are schematics depicting exemplary ports according to the invention;

[0015] FIGs. 18 and 19 depict exemplary excavations according to the invention;

[0016] FIG. 20 presents an exemplary flowchart for an exemplary method;

[0017] FIGs. 21-23 and 27-28 A depict exemplary boring tools according to the invention;

[0018] FIGs. 29-3 IB depict exemplary hand tools and/or use thereof according to the invention; and

[0019] FIGs. 31C to 36 are schematics depicting exemplary embodiments according to the invention.

DETAILED DESCRIPTION

[0020] Merely for ease of description, the techniques presented herein are sometimes described herein with reference to an illustrative medical device, namely a cochlear stimulator, and in other instances, a cochlear implant. However, it is to be appreciated that the techniques presented herein may also be used with a variety of other medical devices that, while providing a wide range of therapeutic benefits to recipients, patients, or other users, may benefit from setting changes based on the location of the medical device. For example, the techniques presented herein may be used with other hearing prostheses, including acoustic hearing aids, bone conduction devices, middle ear auditory prostheses, direct acoustic stimulators, other electrically simulating auditory prostheses (e.g., auditory brain stimulators), etc. Some embodiments include the utilization of the teachings herein to treat an inner ear of a recipient that has and/or utilizes one or more of these devices. The techniques presented herein may also be used with vestibular devices (e.g., vestibular implants), visual devices (i.e., bionic eyes), sensors, pacemakers, drug delivery systems, defibrillators, functional electrical stimulation devices, catheters, seizure devices (e.g., devices for monitoring and/or treating epileptic events), sleep apnea devices, electroporation, etc. In further embodiments, the techniques presented herein may be used with air purifiers or air sensors (e.g., automatically adjust depending on environment), hospital beds, identification (ID) badges/bands, or other hospital equipment or instruments.

[0021] The teachings detailed herein can be implemented in sensory prostheses, such as hearing implants specifically, and neural stimulation devices in general. Other types of sensory prostheses can include retinal implants. Accordingly, any teaching herein with respect to a sensory prosthesis corresponds to a disclosure of utilizing those teachings in / with a hearing implant and in / with a retinal implant, unless otherwise specified, providing the art enables such. Moreover, with respect to any teachings herein, such corresponds to a disclosure of utilizing those teachings with all of or parts of a cochlear implant, cochlear stimulator, a bone conduction device (active and passive transcutaneous bone conduction devices, and percutaneous bone conduction devices) and a middle ear implant, providing that the art enables such, unless otherwise noted. To be clear, any teaching herein with respect to a specific sensory prosthesis corresponds to a disclosure of utilizing those teachings in / with any of the aforementioned hearing prostheses, and vice versa. Corollary to this is at least some teachings detailed herein can be implemented in somatosensory implants and/or chemosensory implants. Accordingly, any teaching herein with respect to a sensory prosthesis corresponds to a disclosure of utilizing those teachings with/in a somatosensory implant and/or a chemosensory implant.

[0022] Thus, merely for ease of description, the first illustrative medical device is a hearing prosthesis. Any techniques presented herein described for one type of hearing prosthesis or any other device disclosed herein corresponds to a disclosure of another embodiment of using such teaching with another device (and/or another type of hearing device including other types of bone conduction devices (active transcutaneous and/or passive transcutaneous), middle ear auditory prostheses (particularly, the EM vibrator / actuator thereof), direct acoustic stimulators), etc. The techniques presented herein can be used with implantable / implanted microphones (where such is a transducer that receives vibrations and outputs an electrical signal (effectively, the reverse of an EM actuator), whether or not used as part of a hearing prosthesis (e.g., a body noise or other monitor, whether or not it is part of a hearing prosthesis) and/or external microphones. The techniques presented herein can also be used with vestibular devices (e.g., vestibular implants), sensors, seizure devices (e.g., devices for monitoring and/or treating epileptic events, where applicable), and thus any disclosure herein is a disclosure of utilizing such devices with the teachings herein (and vice versa), providing that the art enables such. The teachings herein can also be used with conventional hearing devices, such as telephones and ear bud devices connected MP3 players or smart phones or other types of devices that can provide audio signal output, that use an EM transducer. Indeed, the teachings herein can be used with specialized communication devices, such as military communication devices, factory floor communication devices, professional sports communication devices, etc.

[0023] By way of example, any of the technologies detailed herein which are associated with components that are implanted in a recipient can be combined with information delivery technologies disclosed herein, such as for example, devices that evoke a hearing percept, to convey information to the recipient. By way of example only and not by way of limitation, a sleep apnea implanted device can be combined with a device that can evoke a hearing percept so as to provide information to a recipient, such as status information, etc. In this regard, the various sensors detailed herein and the various output devices detailed herein can be combined with such a non-sensory prosthesis or any other nonsensory prosthesis that includes implantable components so as to enable a user interface, as will be described herein, that enables information to be conveyed to the recipient, which information is associated with the implant.

[0024] FIG. l is a perspective view of a human skull showing the anatomy of the human ear. As shown in FIG. 1, the human ear comprises an outer ear 101, a middle ear 105, and an inner ear 107. In a fully functional ear, outer ear 101 comprises an auricle 110 and an ear canal 102. An acoustic pressure or sound wave 103 is collected by auricle 110 and channeled into and through ear canal 102. Disposed across the distal end of ear canal 102 is a tympanic membrane 104 which vibrates in response to sound wave 103. This vibration is coupled to oval window or fenestra ovalis 112, which is adjacent round window 121. This vibration is coupled through three bones of middle ear 105, collectively referred to as the ossicles 106 and comprising the malleus 108, the incus 109, and the stapes 111. Bones 108, 109, and 111 of middle ear 105 serve to filter and amplify sound wave 103, causing oval window 112 to articulate, or vibrate in response to the vibration of tympanic membrane 104. This vibration sets up waves of fluid motion of the perilymph within cochlea 140. Such fluid motion, in turn, activates hair cells (not shown) inside cochlea 140. Activation of the hair cells causes nerve impulses to be generated and transferred through the spiral ganglion cells (not shown) and auditory nerve 114 to the brain (also not shown) where they cause a hearing percept.

[0025] As shown in FIG. 1, semicircular canals 125 are three half-circular, interconnected tubes located adjacent cochlea 140. Vestibule 129 provides fluid communication between semicircular canals 125 and cochlea 140. The three canals are the horizontal semicircular canal 126, the posterior semicircular canal 127, and the superior semicircular canal 128. The canals 126, 127, and 128 are aligned approximately orthogonally to one another. Specifically, horizontal canal 126 is aligned roughly horizontally in the head, while the superior 128 and posterior canals 127 are aligned roughly at a 45 degree angle to a vertical through the center of the individual’s head.

[0026] Each canal is filled with a fluid called endolymph and contains a motion sensor with tiny hairs (not shown) whose ends are embedded in a gelatinous structure called the cupula (also not shown). As the orientation of the skull changes, the endolymph is forced into different sections of the canals. The hairs detect when the endolymph passes thereby, and a signal is then sent to the brain. Using these hair cells, horizontal canal 126 detects horizontal head movements, while the superior 128 and posterior 127 canals detect vertical head movements.

[0027] FIG. 2 is a perspective view of an exemplary cochlear stimulator 200A in accordance with some exemplary embodiments. Cochlear stimulator 200A comprises an external component 242 that is directly or indirectly attached to the body of the recipient, and an internal component 244A that is temporarily or permanently implanted in the recipient. External component 242 typically comprises two or more sound input elements, such as microphones 224 for detecting sound, a sound processing unit 226, a power source (not shown), and an external transmitter unit 225. External transmitter unit 225 comprises an external coil (not shown). Sound processing unit 226 processes the output of microphones 224 and generates encoded data signals which are provided to external transmitter unit 225. For ease of illustration, sound processing unit 226 is shown detached from the recipient.

[0028] Internal component 244A comprises an internal receiver unit 232, a stimulator unit 220, and a stimulation arrangement 250A in electrical communication with stimulator unit 220 via cable 218 extending thorough artificial passageway 219 in mastoid bone 221. Internal receiver unit 232 and stimulator unit 220 are hermetically sealed within a biocompatible housing, and are sometimes collectively referred to as a stimulator/receiver unit.

[0029] Internal receiver unit 232 comprises an internal coil (not shown), and optionally, a magnet (also not shown) fixed relative to the internal coil. The external coil transmits electrical signals (i.e., power and stimulation data) to the internal coil via a radio frequency (RF) link. The internal coil is typically a wire antenna coil comprised of multiple turns of electrically insulated platinum or gold wire. The electrical insulation of the internal coil is provided by a flexible silicone molding (not shown). In use, implantable receiver unit 232 is positioned in a recess of the temporal bone adjacent auricle 110.

[0030] In the illustrative embodiment of FIG. 2, ossicles 106 have been explanted, thus revealing oval window 122.

[0031] Stimulation arrangement 250A comprises both the distal and proximal portions of cable 218 (221 and 240), an actuator assembly 261 A, an actuator mount member 251 A, an actuator position arm 252 A that extends from actuator mount member 251 A and supports or at least holds actuator assembly 261A in place relative to the outside of the cochlea 140. In an exemplary embodiment, actuator mount member 251 A is osseointegrated to mastoid bone 221, or more particularly, to the exit of artificial passageway 219 formed in mastoid bone 221.

[0032] In this embodiment, stimulation arrangement 250A is implanted and/or configured such that a portion of the actuator assembly interfaces with the round window 121, as can be seen, while it is noted that in an alternate embodiment, a portion of the actuator assembly interfaces with the oval window 122 (and both windows in some alternate embodiments).

[0033] As noted above, a sound signal is received by microphone(s) 224, processed by sound processing unit 226, and transmitted as encoded data signals to internal receiver 232. Based on these received signals, stimulator unit 220 generates drive signals which cause actuation of actuator assembly 261 A.

[0034] FIG. 3 is a perspective view of an exemplary internal component 344 of an implant which generally represents internal component 244A described above. Internal component 344 comprises an internal receiver unit 332, a stimulator unit 320, and a stimulation arrangement 350. As shown, receiver unit 332 comprises an internal coil (not shown), and a magnet 321 fixed relative to the internal coil. In some embodiments, internal receiver unit 332 and stimulator unit 320 are hermetically sealed within a biocompatible housing. This housing has been omitted from FIG. 3 for ease of illustration.

[0035] Stimulator unit 320 is connected to stimulation arrangement 350 via a cable 328, corresponding to cable 218 of FIG. 2. Stimulation arrangement 350 comprises an actuator assembly 361, corresponding to actuator 261 A of FIG. 2, an actuator assembly mount member 351, corresponding to actuator assembly mount member 251 A of FIG. 2, and an actuator assembly positioning arm 352, corresponding to the actuator assembly positioning arm 352 of FIG. 2. In an exemplary embodiment, actuator assembly mount member 351 is configured to be located in the artificial passageway 219 or adjacent thereto and fixed to the mastoid bone of the recipient. As indicated by the curved arrows of FIG. 3, the actuator assembly mount member 351 and the actuator assembly 361 are configured to enable articulation of the actuator assembly positioning arm 352 relative to those components. Further, as indicated by the straight arrow of FIG. 3, the actuation assembly positioning arm 352 is configured to telescope to provide longitudinal adjustment between the actuator assembly 361 and the actuator assembly mount member 251.

[0036] FIG. 4 is a perspective view of an exemplary internal component 444 of an implant which generally represents internal component 244A described above. Internal component 444 comprises like components corresponding to those of internal component 344.

[0037] As with internal component 344, internal component 444 is such that stimulator unit 320 is connected to stimulation arrangement 450 via a cable 328, corresponding to cable 218 of FIG. 2. However, element 451 is a coupling that instead of coupling to the articulation device detailed above in the embodiment of FIG. 3, couplies to cable 452 which is coupled to actuator assembly 361. This embodiment provides a less complicated arrangement which can have utilitarian value where the surgeon or the like is going to hand connect actuator assembly 361 directly to the exterior of the cochlea and where actuator assembly 361 will remain in place relative to the cochlea for a given period of time. The cable 452 is flexible so as to permit relative ease of movement of the actuator assembly 361 during the implantation process. The coupling 451 enables the stimulation arrangement 350 to be replaced without removing the stimulator unit 320 and/or enables the stimulator unit 320 to be removed and replaced without removing the stimulation arrangement 450.

[0038] FIG. 4A presents an exemplary embodiment of a neural prosthesis in general, and a retinal prosthesis and an environment of use thereof, in particular. In some embodiments of a retinal prosthesis, a retinal prosthesis sensor-stimulator 1108 is positioned proximate the retina 1110. In an exemplary embodiment, photons entering the eye are absorbed by a microelectronic array of the sensor-stimulator 1108 that is hybridized to a glass piece 1112 containing, for example, an embedded array of microwires. The glass can have a curved surface that conforms to the inner radius of the retina. The sensor-stimulator 108 can include a microelectronic imaging device that can be made of thin silicone containing integrated circuitry that converts the incident photons to an electronic charge.

[0039] An image processor 1102 is in signal communication with the sensor-stimulator 1108 via cable 1104 which extends through surgical incision 1106 through the eye wall (although in other embodiments, the image processor 1102 is in wireless communication with the sensor-stimulator 1108). In an exemplary embodiment, the image processor 1102 is analogous to the sound processor / signal processors of the auditory prostheses detailed herein, and in this regard, any disclosure of the latter herein corresponds to a disclosure of the former in an alternate embodiment. The image processor 1102 processes the input into the sensor-stimulator 108, and provides control signals back to the sensor-stimulator 1108 so the device can provide processed and output to the optic nerve. That said, in an alternate embodiment, the processing is executed by a component proximate to or integrated with the sensor-stimulator 1108. The electric charge resulting from the conversion of the incident photons is converted to a proportional amount of electronic current which is input to a nearby retinal cell layer. The cells fire and a signal is sent to the optic nerve, thus inducing a sight perception.

[0040] The retinal prosthesis can include an external device disposed in a Behind-The-Ear (BTE) unit or in a pair of eyeglasses, or any other type of component that can have utilitarian value. The retinal prosthesis can include an external light / image capture device (e.g., located in / on a BTE device or a pair of glasses, etc.), while, as noted above, in some embodiments, the sensor-stimulator 1108 captures light / images, which sensor-stimulator is implanted in the recipient. In an exemplary embodiment, there is a transcutaneous communication coil that is held against a skin of a recipient via magnetic attraction to communication with an implanted component, which implanted component provides the stimulation to evoke a sight precept. In an embodiment, the teachings herein regarding magnetic attraction are utilized in such.

[0041] In the interests of compact disclosure, any disclosure herein of a microphone or sound capture device corresponds to an analogous disclosure of a light / image capture device, such as a charge-coupled device. Corollary to this is that any disclosure herein of a stimulator unit which generates electrical stimulation signals or otherwise imparts energy to tissue to evoke a hearing percept corresponds to an analogous disclosure of a stimulator device for a retinal prosthesis. Any disclosure herein of a sound processor or processing of captured sounds or the like corresponds to an analogous disclosure of a light processor / image processor that has analogous functionality for a retinal prosthesis, and the processing of captured images in an analogous manner. Indeed, any disclosure herein of a device for a hearing prosthesis corresponds to a disclosure of a device for a retinal prosthesis having analogous functionality for a retinal prosthesis. Any disclosure herein of fitting a hearing prosthesis corresponds to a disclosure of fitting a retinal prosthesis using analogous actions. Any disclosure herein of a method of using or operating or otherwise working with a hearing prosthesis herein corresponds to a disclosure of using or operating or otherwise working with a retinal prosthesis in an analogous manner.

[0042] Some exemplary embodiments of the teachings detailed herein enable drug delivery to the cochlea or otherwise the delivery of a utilitarian substance to the cochlea.

[0043] FIG. 5 depicts an exemplary drug delivery device, the details of which will be provided below. It can be utilitarian to have a prompt and/or extended delivery solution for use in the delivery of treatment substances to a target location of a recipient. In general, extended treatment substance delivery refers to the delivery of treatment substances over a period of time (e.g., continuously, periodically, etc.). The extended delivery may be activated during or after surgery and can be extended as long as is needed. The period of time may not immediately follow the initial implantation of the auditory prosthesis. Embodiments of the teachings herein can facilitate extended delivery of treatment substances, as well as facilitating prompt delivery of such substances.

[0044] FIG. 5 illustrates an implantable delivery system 200 having an actuation mechanism, which can be modified as will be detailed below in some embodiments. However, it is noted that the delivery system 200 can also or instead have an active actuation system, again which can be modified as will be detailed below. The delivery system 200 is sometimes referred to herein as an inner ear delivery system because it is configured to deliver treatment substances to the recipient’s inner ear (e.g., the target location is the interior of the recipient’s cochlea 140). It is also noted that in some implementations of a modified arrangement of FIG. 5, as will be described below, the actuation mechanism enables movement of therapeutic substance to another device that in turn has an active actuation mechanism (e.g., element 361 of FIG. 6A, additional details of which are described below), where the latter is used to actually transport the therapeutic substance into a cochlea (the former is used to get the substances to the latter).

[0045] Delivery system 200 of FIG. 5 comprises a reservoir 202, a valve 204, and a delivery tube 206, in addition to some additional components, as will be described below. For ease of illustration, the delivery system 200 is shown separate from any implantable auditory prostheses. Additionally, the delivery system 200 can include, or operate with, an external magnet 210, which is separate from or part of the implantable auditory prostheses, for purposes of, e.g., controlling operation of valve 204.

[0046] The delivery tube 206 includes a proximal end 212 and a distal end 214. The proximal end 212 of the delivery tube 206 is fluidically coupled to the reservoir 202 via the valve 204.

[0047] FIG. 5, as shown, utilizes an actuation mechanism to produce a pumping action to transfer a treatment substance from the reservoir 202 to the delivery device 208 at the distal end 214 of the delivery tube 206, but again, some embodiments are modified versions of FIG. 5 that utilize active actuation.

[0048] In some implementations of FIG. 5, external force is applied on the tissue 219 adjacent to the reservoir 202 to create the external force. As will be described below, in some embodiments, an external vibratory device of a passive transcutaneous bone conduction device that vibrates to evoke a hearing percept is pressed onto the soft tissue 219 under which the reservoir 202 is located. The movement (e.g., oscillation/vibration) of the actuator causes deformations the reservoir 202 to create the pumping action that propels the treatment substance out of the reservoir.

[0049] As noted, the treatment substance (sometimes herein referred to as therapeutic substance) is released from the reservoir 202 through the valve 204. The valve 204 may be a check valve (one-way valve) that allows the treatment substance to pass therethrough in one direction only.

[0050] Once the treatment substance is released through valve 204, the treatment substance flows through the delivery tube 206 to the cochlea, either directly, or indirectly via the actuator assembly 361 / 461. In embodiments utilizing the actuator assembly, the actuator assembly corresponds to a transfer mechanism to transfer the treatment substance from the delivery tube 206 into the cochlea 140 via the round window 121 (or oval window, or another orifice such as that established by a cochleostomy into the cochlea). [0051] The reservoir 202 may include a notification mechanism that transmits a signal or notification indicating that the reservoir 202 is substantially empty and/or needs refilled. For example, one or more electrode contacts (not shown) may be present and become electrically connected when the reservoir is substantially empty. Electronic components associated with or connected to the reservoir 202 may accordingly transmit a signal indicating that reservoir needs filled or replaced.

[0052] As noted herein, the therapeutic delivery system of figure 5 can be combined with a partially or fully implanted device configured to evoke a hearing percept. By way of example only and not by way of limitation, the therapeutic delivery system of figure 5 can be combined with the hearing prosthesis of figure 3 and figure 4. Briefly, in an exemplary embodiment, the actuator assembly 361 can be configured so as to receive or otherwise connect to the distal end of tube 206 of the therapeutic delivery system. In an exemplary embodiment of such as depicted in figure 6A, where the embodiment of figure 4 is presented by way of example, it is to be understood that the embodiment of figure 6 is also applicable to the embodiment of figure 3.

[0053] FIG. 8 depicts a side view partial cross-sectional view of an exemplary inner ear port device 800, which extends from the middle ear cavity 106, through the bone structure 123, that divides the middle ear cavity 106 from the interior of the cochlea 199, and thus extends therethrough.

[0054] In at least some examples, the port device 800 is attached to the wall of the cochlea 123 at a location away from the round window and/or from the oval window. In this regard, the passage through the wall the cochlea 123 can be established via a cochleostomy through the bony structure of the cochlea 123. FIG. 8 depicts a body 810. A passage 819 extends through that body. While in at least some exemplary examples, the passage 819 can include only a seal apparatus, or the passage 819 has a second component, here, module 820, located therein, which module in turn has a passage 822. Body 830 is screwably attached to module 820, which body forms a head of an assembly that includes module 820 (the assembly can be considered itself a module - thus, there is a first module, body 810, and a second module that is the assembly of head 888 and element 820 (or, just element 820 can be considered the second module)). In an example, pulling on the head 888 pulls out the element 820 from the passage through the body 810. That said, in some examples, element 830 / head 888 is separate from module 820. In the examples depicted in FIG. 8, both passages extend from inside the cavity 199 to outside the cavity 106. This as compared to, for example, other examples where one or both of the passages extend only to the cavity 199 and/or to the cavity 106 (the passage would stop at the interface / extrapolated interface, of the cavitie(s)). This also as compared to, for example, other examples, where one or both of the passages do not even extend to the respective cavities, where, for example, the “end” / “beginning” of the respective passages stop short / begin after the interface/extrapolated interface, of the cavitie(s). It is also noted that the aforementioned features associated with the passages can also be applicable to the overall body configuration.

[0055] Briefly, as seen in figure 8, the body 810 includes one or more protrusions 812 that can extend circumferentially about the body and/or can be located at discrete portions on the outer surface of the body 810 (e.g., they could be barbs, or spikes), and thus a combination can be utilized in some examples. In this example, the protrusions 812 can be ribs that can have sharp edges, which will grip the bone 123 or other tissue with which the body 810 interfaces. In an exemplary example, the protrusions 812 can instead be a single screw thread (and thus there would be one protrusion) and/or a plurality of screw threads, thus enabling the body 810 to be screwed into the passage.

[0056] In an example, the screw thread(s) of the inner ear port device can be self-tapping screw threads, more accurately, a tissue interface portion, such as body 810, of the inner ear port device can be configured as a self-tapping screw arrangement. Thus, examples include establishing a passageway through the bone between the middle ear cavity and the inner ear cavity without drilling. That is, by way of example only and not by way of limitation, at the location where an inner ear device as detailed herein and/or variations thereof are positioned, the first time that the barrier between the inner ear and the middle ear at that location is breached is by the inner ear port device.

[0057] While the example depicted in figure 8 shows a tapered body, other examples could have an outer surface that maintains the same distance from the longitudinal axis for at least a portion of its length, such as the portion that extends through the passage. This is seen in figure 9, which shows a cross-section of a body 1010 of a port 1000, which cross-section lies and is parallel to the longitudinal axis of the body. This example does not show the protrusions 812, but in other examples, the protrusions can be located on the outer surface. This example has an o-ring 924 between body 1010 and funnel portion 1023 (which can be made out of titanium, for example). Funnel portion 1023 includes an elongate passage in which an elastomeric component 1030 is located, which includes wires 849 or otherwise an electrically conductive material configured to conduct electrical current for the purposes of conducting an electrical signal. In an exemplary embodiment, the electrically conductive material can be lead wires. In an exemplary embodiment, the inner ear port includes electrodes that are connected to the lead wires 849.

[0058] In some examples, brackets can be utilized to fix the port to bone. For example, this can be seen in FIG. 10, where bracket 11110 is seen press fitted / interference fitted about the core of the body 1011 (collectively, the 1111 and the core 1011 make up the body - the core 1011 can be identical to the aforementioned body 1010 of figure 10 in some examples, and in others, can be different. For example, because of the bracket, a roughened surface /outer surface of the body 1010 that might be utilized to aid in the fixation might not be utilized with the core 1011 of figure 11, which presents an exemplary example of an inner ear port device 1100 while in other examples, the roughened surface is utilized).

[0059] Here, the bracket has holes therethrough (not labeled) that receive one or more bone screws 1121 as seen. In an exemplary example, the bone screws are what hold the body / fix the body to the passage. In an exemplary example, a combination of the bone screws and an interference fit and/or a press fit with the passage through the bone 123 can be utilized. Note also that instead of bone screws and/or in addition to bone screws, bone cement or the like can be utilized, such as by way of example, by packing the bone cement between the flange 1111 and the surface of the bone 123 that faces the flange. It is noted that in at least some exemplary examples, the flange 11110 and the body 1011 are part of a monolithic component, which component can be turned on a lathe, from, for example, a thick-walled tube. Alternatively, the flange 11110 can be a washer type device or a ring type device which can be press fit or interference fitted on to a tube 1011.

[0060] Also seen is a large plug 1130 and a ring bracket 1122 that stops the plug from being inserted through the body and into the cavity 1199.

[0061] Embodiments of the present invention key off of the embodiment of FIG. 7, and are different from the examples of FIG.s 8-10 (although embodiments can use some of the features thereof, as will be detailed for example below - in an embodiment, unless otherwise specified, any of the structural features of the embodiments of FIGs. 8-10 can be used in the embodiments of FIG. 11 and thereafter, providing that the angular features as detailed below are met). FIG. 7 presents an exemplary embodiment that is different than that disclosed in FIGs. 5-6. In this regard, the invention of this patent application corresponds to the embodiments of figure 7 and the figures after figure 10. Any means-plus-function claims relating to the implant as a whole corresponds to the structure of figure 7 and/or the figures after FIG. 10. But again, some exemplary embodiments of the invention can utilize some of the structure and/or function of the teachings detailed above, and the features of FIGs. 8, 9 and 10 detailed above are not repeated below for the purposes of textual economy. And embodiments of the implants according to the invention can include one or more of the above noted structures and/or functions and/or can include methods that include one or more of the above noted method actions. However, with respect to the implant, the invention does not include the implants detailed above. This is thus related art that some aspects of the invention can utilize.

[0062] It is also briefly noted that in figure 7, the ossicles have been removed (from the figure) in the interest of clarity. Some embodiments can be utilized with an intact ossicles, while other embodiments are utilized in a human where the ossicles of the respective middle ear cavity has been removed. To be clear, embodiments according to the teachings detailed herein are directed towards preserving hearing or otherwise treating hearing loss, and thus in some embodiments, the ossicles are present and functioning. But it is noted that the absence of the ossicles does not rule out embodiments associated with preserving hearing and/or treating hearing loss - hearing could be established via a middle ear implant and/or a bone conduction implant and/or a cochlear implant electrode array, etc. For example, embodiments of the teachings detailed herein can be utilized to preserve or otherwise prevent cilia degradation, where the ossicles have completely deteriorated to the point of not being useful from a medical standpoint - they might be there, but they do not function in a medically meaningful way for example. It is briefly noted by way of background that, in general, absent the teachings associated with FIG. 7 and FIG. 8 (more on this below) and variations thereof, access to the inner ear has the potential to cause damage to hearing and/or balance. Moreover, again absent the teachings associated with FIGs. 7 and 8, repeated access to try different therapies, or for repeated application of drugs, can often create added risk. For example, drug delivered to the middle ear is poorly transferred to the inner ear (thus meaning that the efficacy can be relatively low, for example). In general, providing a drug treatment to the inner ear by placing drug in the middle ear is challenging. Some access the cochlea using cochlear implant techniques and sheath introducers. Hearing drug companies often attempt to deliver to the middle ear using gels delivered to the inner ear with single shot approaches. Indeed, the standard of care for drug delivery to the ear today is middle ear injection in solution. Often, hearing drug companies try to improve delivery to the inner ear by using gels in the middle ear or by using single shot direct cochlear injection (direct in that the termination contacts directly the tissue establishing a barrier between the middle ear and the inner ear).

[0063] Figure 11 presents an exemplary port 1100 that differs from those of figures 8 to 10 with respect to heliport interfaces with the bone 123 that establishes the boundary between the inner ear 199 cavity and the middle ear cavity 106, where port 1100 can correspond to the inner ear port device 700 noted above, which extends from the middle ear cavity 106, through the bone structure 123, that divides the middle ear cavity 106 from the interior of the cochlea 199, and thus extends therethrough.

[0064] In some embodiments, the port device 1100 does not extend through the wall of the cochlea at the location of the round window or oval window or more accurately, or potentially, the former location of the round window or oval window. Thus, in some examples, the device is located in a cochleostomy away from a natural round window location of a human and away from a natural oval window location of a human.

[0065] The port device can extend through the promontory. The port device can extend through the barrier between the middle ear and the inner. The port device can extend through the wall of the first turn of the cochlea. The port device can extend through the bone between the round and oval window. In this example, the port device 1100 includes a portion that is located in or otherwise is accessible from the middle ear cavity 106. Also as seen, the port device 1100 includes a portion that is located in or otherwise is in fluid communication with the cavity 199 of the cochlea, which can be one or more of the three ducts of the cochlea. In an exemplary example, therapeutic substances can be transferred from a location within the cavity 106 into the cavity 199 through the port 1100.

[0066] Port 1100 includes body 1110 that is rotationally symmetric about axis 889. The body 1110 includes a portion of larger diameter and a portion of smaller diameter (both inner and outer), the details of which will be provided below. These two portions are part of a single monolithic body and can be manufactured by extrusion or casting or stamping. Embodiments can include machining the body 1110 from a cylindrical piece of stock material, such as titanium. The body 1110 is hollow on the inside as shown, and includes a passage 822 that extends completely into the cavity 199 of the inner ear. In an exemplary embodiment, plug 1130, which can be an elastomeric plug such as a plug made out of silicone or some other biocompatible material that can have utilitarian value with respect to ceiling the passageway from middle ear to the interior. In this embodiment, the body 1110 is adhesively bonded by bone cement 1111 to a relatively planar surface of the cavity 12399 excavated or otherwise cut / grinded from the bone 123. Alternatively, and/or in addition to this, sides of the body 1110 can be threaded so as to screw into the bone 123 at the side walls of the portion 12399 removed from bone 123. Alternatively, and/or in addition to this and/or in addition to the bone cement 1111, and interference fit can be established between the inner diameter of the cavity 12399 and the outer diameter of the body 1110. Also, while the bone cement 1110 or otherwise the adhesive is shown as being located only at the axial face of the body 1110, in an alternate embodiment, the bone cement 1111 can be located elsewhere, such as instead only at the radial sides of the body 1110, or both places.

[0067] FIG. 11 A presents an alternate exemplary port 1100 A a ring flange 1115 interference fitted to the outside of the body 1110, although in other embodiments, flange 1115 can be monolithic with the remainder of the body 1110. In this embodiment, flange 1115 is provided at a location along the longitudinal axis 889 where it is unlikely that the flange 1115 will contact the surface of the bone establishing the boundary 123. In this embodiment, bone cement 1119 is located between the flange 1115 and the surface of the bone so as to adhere the port 1100 A to the bone.

[0068] By sizing and dimensioning the flange 1115 so that it will not contact the bone, the controlling features that control placement of the port 1100 A are the axial surface of the body 1100. In this embodiment, the sizing and dimensioning enables the bone cement 1119 to squeeze out the sides (or be injected from the sides) so that the bone cement does not interfere with the ultimate positioning of the port (at least cement 1119). In an exemplary embodiment, the surgeon or other healthcare professional can, after placing the body 1110 into the cavity 12399, inject bone cement around the sides and thus in between the surface of the bone 123 and the facing surface of the flange 1115. The healthcare professional can hold the body 1110 in place by providing force or pressure from left to right with respect to the orientation shown in figure 11A on to the body 1110 until the cement is cured or otherwise hardens and sufficiently retains the body to the bone. Alternatively, the bone cement can be placed onto the surface of the bone before the body is placed into the cavity 2399, and then as the body is pushed into the cavity, the bone cement oozes out the sides, which should only happen because the bone cement is in contact with the surface of the bone in the surface of the bone and the surface of the flange. This should ensure that there is contact between the pertinent surfaces and the bone cement so as to obtain the proper or needed adhesion. Of course, as shown in the embodiment of figure 11 A, there is also bone cement located on the axial surfaces as in the embodiment of FIG. 11. This is optional. In an exemplary embodiment, the bone cement can also extend from the axial surface of the cavity to the radial surface and then outward and to the sides along the outer surface of the bone (along the sides - this can also be the case in the absence of the flanges 1115.

[0069] FIG. 1 IB is a variation of the embodiment of figure 11A except here, there are the projections 1117 that extends from the flange 1115. These feet projections become encased in the bone cement 1119 and thus provide a modicum of positive retention relative to the bone cement. This is opposed to the surface to surface retention that exists with the flange only. It is noted that in some variations, this feature can be utilized with respect to the cavity 12399.

[0070] In an embodiment, at least 50, 55, 60, 65, 70, 75, 80, 85, 90, 95 or 100% of all bone cement / adhesive used as part of the port prosthesis is located directly against the flat surface.

[0071] The embodiments shown in the figures do not present bone cement located between the portion of the body that has the smaller outer diameter and the bone. In an exemplary embodiment, there can also be bone cement between these radial surfaces.

[0072] An O-ring seal can be used to seal between cavity 106 and cavity 199 (and can aid in retention of the body in cavity 12399. FIG. 11B shows an O-ring seal 1177. The O-ring seal can be physically supported by body 1110 (meaning that the O-ring moves with the body - shown, the O-ring is in a groove about the body 1110) or can be rolled down body 1110 and pushed into the cavity. A plurality of seals can be utilized. The O-ring is compressed in use and the seal is formed in the traditional manner.

[0073] FIG. 11C shows a different port prosthesis / inner ear prosthesis, prosthesis 1100C, which as a body 1110C that is not rotationally symmetric (at least not about the longitudinal axis of the passageway 822). Here, the body 1110C is shaped so that the center of volume is located above the longitudinal axis of the passageway 822. This can have utilitarian value with respect to providing an interior of the body 1110C that has larger volume than a purely rotational symmetric body in the event that there is structure of the human below (with respect to the frame of reference of figure 11C) the planned location of the port and/or whether there is need to keep that area open, such as, for example, in the event that a cochleostomy is to be utilized to insert a cochlear implant electrode array and/or in the event that there is an existing cochlear implant electrode array located below the port body where the planned port body when attached to the human. Put another way, the port bodies can be sized and dimensioned so as to avoid certain structure and/or componentry in the middle ear, but can provide increased volume relative to the ports of FIG. 11 and 11 A, etc. In at least some of these embodiments, the controlling geometric feature or otherwise the important geometric feature is the flat surface that interfaces with the bone. The features of the port away from that teacher can be different or otherwise need not be controlled by that feature, as shown. And in the interest of at least partial completeness, the increased interior volume of the port body 1110C can be utilitarian with respect to providing a therapeutic substance in the port that has a larger volume than that which would be the case with respect to some of the other ports disclosed herein.

[0074] Embodiments can include the utilization of a self-healing septum. FIG. 1 IB shows such a septum 1190. The septum 1190 is configured to permit repeated puncturing and subsequent healing by a termination of a syringe. The termination can be inserted through the septum so that a therapeutic substance can be injected into the area of the body to the right of the septum, and thus be in fluid communication with the cavity 199 of the middle ear.

[0075] Embodiments can enable repeated sealingly access from the middle ear to the inner ear through a sealable passage in the prostheses / inner ear port 1100. This can be achieved, by way of example, by removal of the cap / plug 1130 from body. Alternatively, and/or in addition to this, in an exemplary embodiment, this can be enabled by, for example, a self- healing septum. In this regard, in an exemplary embodiment, the cap and/or septum can be at least is indirectly releasably attached to the tissue interface portion (body 1110) and/or a portion of the device supported by the tissue interface portion can include a self-healing septum.

[0076] FIG. 11B presents implant 1100B, which includes septum 1190 which is configured to self-heal. Septum 1190 seals the passageway through the body 1110 and otherwise establishes a barrier between the cavity of the inner ear 199 and the cavity of the middle ear 106. In an exemplary embodiment, septum 1190 is configured to receive and otherwise permit a termination of a syringe, such as that of a hypodermic syringe, to pass therethrough in a manner analogous to or otherwise the same as liquid medical containers that include septums (self-healing septums) that enables the termination of the syringe to pass therethrough to access the liquid therapeutic substance in the container. In at least some exemplary embodiments, any device, system, and/or method that will enable repeated sealingly access from the middle ear to the inner ear can be utilized in some embodiments.

[0077] In some embodiments, a cap can be placed over the end to isolate the septum from the middle ear cavity, which cap is removable.

[0078] In an embodiment, there is thus a device, comprising a tissue interface portion configured for securement to tissue of and/or proximate a barrier between a hollow body portion of a human (the hollow could be a duct of the cochlea, a duct of the semi-circular canals, or a hollow of the eye socket or the hollow of the skull that encompasses the brain) and configured to provide a passage from outside the hollow body portion to inside the hollow body portion, wherein the tissue interface portion has a longitudinal axis, a surface of the tissue interfacing portion that directly interfaces with tissue and/or indirectly interfaces with tissue when the tissue interface portion is secured to the tissue is more normal than parallel to the longitudinal axis, and the surface is located at a distal section of the tissue interface portion.

[0079] FIG. 12 presents an exemplary implant 1251 that includes a different type of septum arrangement. Here, the septum includes an outer septum portion 2554 that is relatively thickwalled and an inner septum portion 2564 that is relatively thin-walled as shown. In an exemplary embodiment, both portions of the septum can be pierced, but with some semicareful alignment of the termination, the thin-walled septum can be repeatedly or more frequently pierced relative to the thick-walled.

[0080] As shown in figure 12, the thin-walled septum portion 2564 is located proud of the thick-walled septum portion 2554. In an alternate embodiment, the thin-walled septum portion can be recessed relative to the forward facing surface of the thick-walled septum portion. Indeed, the thin-walled septum portion 2664 can be also located in a manner where the thick-walled septum portion extends over the top and bottom of a portion of the thinwalled septum portion 2664.

[0081] And it is also noted that while the aforementioned septums have been described in terms of a device that enables a termination to be passed therethrough, it is also noted that in other embodiments, other devices can be passed therethrough, such as, for example, a solid therapeutic substance, or a sensor / a boom that supports a sensor at the distal end thereof, etc., or a termination of an endoscope. (This may or may not be a self-healing septum, depending on the size of the portion extending therethrough.) [0082] Embodiments of the septums detailed herein, such as the self-healing septums, or any of the other port devices for that matter, are configured to avoid leakage of fluid from within the cochlea or otherwise within the inner ear to the middle ear or otherwise outside the inner ear, or at least avoid substantial leakage that would have a noticeable deleterious effect and/or an annoyance effect. By way of example only and not by way of limitation, a leakage rate can be limited to 0.1 to (no more than) 10 microliters or any value or range of values therebetween in 0.01 microliter increments. These can be absolute values, or values that occur after a period of time lasting 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 days, or weeks, or any value or range of values therebetween in 1 hour increments.

[0083] Indeed, in this regard, embodiments of the plugs and/or other devices that “fill” the body that interfaces with the tissue of the inner ear detailed herein, or the body itself for that matter, are configured to avoid leakage of fluid from within the cochlea or otherwise within the inner ear to the middle ear or otherwise outside the inner ear, or at least avoid substantial leakage that would have a noticeable deleterious effect and/or an annoyance effect. Leakage can be limited to the aforementioned values.

[0084] In an exemplary embodiment, plugs / bodies located in the tissue interfacing body can be made of a silicone or a polymer and/or a low durometer polymer. The septum can be configured for utilization with a non-coring needle / termination, and thus the teachings detailed herein can be utilized with such and include methods of utilizing such.

[0085] FIG. 13 presents an exemplary implant 1313, that includes self-healing septum 2444 (which is a passive component). A funnel 2588 is attached to the body 1110. FIG. 13A shows a variation, where it can be seen that the funnel thus guides a termination during insertion into the body, and centers the termination with respect to the passage 822.

[0086] FIG. 14 presents an alternate embodiment where a thin-walled septum portion can be recessed relative to the forward facing surface of the thick-walled septum portion. Indeed, as shown in figure 14, the thin-walled septum portion 2664 is also located in a manner where the thick-walled septum portion extends over the top and bottom of a portion of the thinwalled septum portion 2664. Also shown in figure 14, with respect to the implant 1400, there can be seen a third component 2621, that is in the form of a rotationally symmetric body (for purposes of illustration, as is sometimes the case elsewhere, the back lines are not shown in many instances - in real life, there would be a vertical line at the leftmost side, while there is a vertical line at the right most side of the body 2621) that has a cone shaped interior as can be seen. This can have utilitarian value with respect to guiding the tip of the termination to the septum in general, and the thin-walled septum portion 2664 in particular. And in this embodiment, it can be seen that the guide body 2621 is a separate component entirely from the septum portion, where removal of the guide body 2621 would not move the septum. Figure 15 presents an exemplary embodiment of an implant 1500 where the guide body and the septum are part of a single component 2721 (the septum can be locked into the guide body with a spring lock or glue or a second body that is screwed to the distal bore). In an exemplary embodiment, the body 2721 can be screwed into body 810 or interference fitted, etc. Also, while the conical shape for the termination guide is shown as being limited to the diameter of the bore, in an alternate embodiment, the termination guide can extend further outward.

[0087] In an exemplary embodiment, the septum can be located within a rigid ring, such as a ring made out of titanium or a titanium alloy or some other biocompatible metal. In this regard, referring back to FIG. 14, element 2664 can be the septum, and the supporting element can be the ring.

[0088] In this exemplary embodiment, referring back to FIG. 11 for example, element 1130 is a plug that is unscrewable from the body 1110, for example, and removed from the body 1110, but when attached to body 1110, element 1130 will move in a one-to-one relationship with the body 1110. In an exemplary embodiment, the plug 1130 can be made out of biocompatible silicone. A cap can be used instead of a plug.

[0089] The element 1130 can be a silicone body or some other body that is made of biocompatible material. In an exemplary embodiment, element 1130 can also establish a seal with respect to the interface between element 1130 and the body 1110.

[0090] In any event, in at least some exemplary embodiments, when element 1130 is located in body 1110, the only way that fluid can transfer from the cavity 106 to the cavity 199 and/or vice versa is through passage 822. In this regard, the fit of the body in the cavity / opening in the bone and/or the adhesive / bone cement is sufficient to prevent fluid from easily transferring from the middle ear to the inner ear and/or vice versa.

[0091] Embodiments of FIGs. 11-15 (and others) differ from the designs of FIGs. 8-10 in that the angle of interface of major surface(s) of the implant 1100 relative to the longitudinal axis thereof is substantially different. More particularly, with reference to figure 16, the tangent plane 899 of the surface 1510 that extends in the axial direction from the small cylinder portion 1520 extends at an angle A2. As shown, angle A2 is 90 degrees. Put another way, plane 899 bifurcates sections 1630 and 1620 of the body 1110, and as shown, the transition from the large outer diameter DI of section 1630 to the diameter D2 of section 1620 is abrupt as possible with an angle A2 equaling 90 degrees.

[0092] In these embodiments, surface 1510 is the major interface surface between the bone and the implant. Conversely, in the designs of FIGs. 8, 9, and 10, the surface that is the major interface between the bone and the implant has an angle Al that is substantially different from A2. (Note that the ribs / threads 812 could have a surface tangent that has a value closer to A2 than Al, but those are not the major surface interfaces.) Put another way, the major surface interface is the angle established by the overall direction of extension of the interfacing portion. It is the global extension as opposed to pieces of a local extension. For example, if there was a rib projecting in the direction of the longitudinal axis from surface 1510, that could have an angle approaching Al, but that is not the overall direction of extension (which is shown as 90 degrees in FIG. 16.)

[0093] In some embodiments, the port is a device that is a radial surface supported device. This as opposed to an axially supported device such as the embodiment of FIGs. 8 and 9. In some embodiments, the port is a device that is a radial surface bone interface device. This as opposed to an axially supported device such as the embodiment of FIGs. 8 and 9 and 10. Moreover, embodiments can be a screwless supported device, differentiating from FIGs. 8, 9 and 10.

[0094] FIG. 17 shows that the axially extending surface 1710 can extend at an angle that is different than 90 degrees (angle A3). In an exemplary embodiment, angle A3 can be 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120, 125, 130, or 135 degrees, or any value or range of values therebetween in 0.1 degree increments (e.g., 95.3, 99.9, 85.5 to 95.1, etc.).

[0095] In an exemplary embodiment, the angle A3 is measured from an average trajectory that is established by the mean, median, and/or mode, of the total individual tangent plane angles taken at 0.1 mm increments along the longitudinal axis of the surface that is in contact with bone at the securement locations (e.g., if section 1620 has no securement value, it is not included). That is distinct from a surface that is a major interface. This is a collection of all surfaces that are in contact.

[0096] In an exemplary embodiment, the surface from which angle A3 (which includes angle A2) is measured is the surface that constitutes the largest single surface area in contact with the bone (directly or indirectly (indirectly is the case where there is bone cement between the surface and the bone for example)).

[0097] In an exemplary embodiment, angle A3 is a feature that qualifies a surface. For example, surfaces having a tangent plane that is on that angle. In an exemplary embodiment, the surface falls within two parallel planes that are within 1, 0.75, 0.5, 0.25, 0.1, 0.09, 0.08, 0.07, 0.06, 0.05, 0.04, 0.03, 0.02, 0.01 mm or less, or any value or range of values therebetween in 0.005 mm increments, the planes lying on the angle A3 and/or falling within the angle A3 relative to the length of the surface.

[0098] In an exemplary embodiment, the surface from which A3 is measured has an area that is less than, greater than and/or equal to 25, 24, 23, 22, 21, 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, or 5 mm ² , or any value or range of values therebetween on 0.1 mm ² increments.

[0099] In an embodiment, when looking down the longitudinal axis from the inner ear end of the port, of all surfaces that are visible (which does not include eclipsed surfaces, such as may be the case with the far side of a thread), a mean, median and/or mode of these surfaces have tangent planes that meet the above noted angle values.

[ooioo] FIG. 17A shows two surfaces 1710A and 1710B in an embodiment. Surface 1710A can have the features of surface 1710, but is limited in length by surface 1710B, which can have the features of surface 1710 but with a different angle A3 A from surface 1710B. Any angle of A3 above can correspond to angle A3 A. FIG. 17A depicts A3 A as 90 degrees. And note that the surfaces singularly and/or collectively can meet any of the features disclosed herein for surface 1710, etc. Note also that in other embodiments, there can be three, four, five or more surfaces at issue. Note that the above noted areas can correspond to the collective surface area of the surfaces that are more normal than parallel to the longitudinal axis.

[ooioi] In an exemplary embodiment, DI is less than and/or equal to 6, 5.5, 5, 4.5, 4, 3.5, 3, 2.5, 2, or 1.5 mm, or any value or range of values therebetween in 0.1 mm increments. The outer diameter of section 1620 can be less than and/or equal to 75, 70, 65, 60, 55, 50, 45, 40, 35, 30, 25, 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, or 5%, or any value or range of values therebetween in 0.1% increments of the value of DI. D2 and/or D3 can be less than, and/or equal to 50, 60, 70, 80, 90, 100, 125, 150, 175, 200, 225, 250, 275, 300, 350, 400, 450, 500, 550, 600, 650, 700, 750, 800, 900, 1000, 1250, 1500 microns, or any value or range of values therebetween in 1 micron increments. (D3 need not equal D2.) Lower values can be used for drug delivery / therapeutic substance delivery, for example. An embodiment includes delivering drugs / therapeutic substances using the port where the diameter D2 is less than 0.2 mm.

[00102] D3 can also be longer than 1500 microns, such as 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4 mm or more, or any value or range of values therebetween in 0.01 mm increments. The overall length of the body 1110 can be less than and/or equal to 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, or 10 mm, or any value or range of values therebetween in 0.01 mm increments. D3 can be less than and/or equal to 75, 70, 65, 60, 55, 50, 45, 40, 35, 30, 25, 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6 or 5% or any value or range of values therebetween in 0.1% increments of the overall length.

[00103] In an exemplary embodiment, D3 is of a length so that the distal end of the portion 1520 of the body extends into the cavity 199 so that the distal end is proud of the interior surface establishing the cavity. This is shown in figure 11. In an exemplary embodiment, immediately after full implantation, and/or within 0.5, 1, 1.5 or 2 hours after full implantation, the distal end of the portion 1520 is located no closer than 200, 225, 250, 275, 300, 350, 400, 450, 500, 550, 600, 650, 700, 750, 800, 900, 1000, 1250, 1500, 1750, 2000, 2500, or 3000 microns, or any value or range of values therebetween in 1 micron increments from the tissue forming the surface of cavity 199 immediately at the breakthrough and/or from any tissue forming the surface of cavity 199 (the values need not be the same). In an exemplary embodiment, at least some of these lengths can prevent or at least frustrate overgrowth of bony tissue or other types of tissue over the distal opening of the port. In this regard, in an exemplary embodiment, after the port is implanted, the body will attempt to “heal” itself, and thus grow tissue around the portion 1520. This tissue can extend into the excavation 1820 at least partially, and can help seal the passageway between the bone and the outer surface of the port. There can be utilitarian value in this. In an exemplary embodiment, the portion 1520 of the body is made of a material that enhances osseointegration or otherwise fibrous tissue attachment to the port. This surface feature may or may not be present at other locations of the port, such as the flat surface and/or the flat surfaces of the larger outer diameter of the port. That said, the bone cement and/or adhesive may frustrate the ability of tissue growth to attach to the implant at that those locations. Corollary to this is that the interior diameter of the portion 1520 can be made of the material or otherwise have a substance that resists attachment of fibrous tissue growth. This can also be the case with respect to the distal surface of the portion 1520. The idea being is that the fibrous tissue growth is undesirable in at least some embodiments with respect to the interior of the port. That said, there can be utilitarian value with respect to having tissue growth extending over and across the distal end of the port. This can act as a seal between the entire or at least substantially all and/or effectively all of the interior of the port and the interior of the cochlea. This seal can be broken when it is desired to access the interior of the cochlea, such as by, for example, extending a termination or a needle through the tissue that has grown over the end of the portion 1520. Thus, fibrous tissue growth can be encouraged at certain locations so as to add a redundant seal over and beyond what the cap / plug and/or the self-healing septum may provide. Thus, in an embodiment, it can be utilitarian to have the distal end of the portion 1520 closer to the interior surface of the cochlea, such as the surface at the breakthrough point, then that detailed above. The closer the distal end of portion 1520 is to the surface, the more likely that the tissue will overgrow the distal end of the port. Thus, in an exemplary embodiment, immediately after full implantation, and/or within 0.5, 1, 1.5, or 2 hours after full implantation (thus without the new tissue growth), the distal end of the portion 1520 is located closer than 200, 225, 250, 275, 300, 350, 400, 450, 500, 550, 600, 650, 700, 750, 800, 900, 1000, 1250, or 1500 microns, or any value or range of values therebetween in 1 micron increments to the tissue forming the surface of cavity 199 immediately at the breakthrough and/or to any tissue forming the surface of cavity 199 (the values need not be the same). Indeed, in an exemplary embodiment, with respect to the just- detailed time frames, the distal end of portion 1520 could be below grade of the surface at the breakthrough (that is, the distal end does not extend into the cavity proper at all). Thus, embodiments include utilizing ossification to at least partially seal the passage from the middle ear to the inner ear after it is established.

[00104] It is noted that embodiment can be configured to encourage the growth of the tissue seal. In an embodiment, the tissue grows back after each puncture (providing that time is given to grow back) through the tissue.

[00105] In view of the above, it can be seen that in some embodiments, there is a device, such as an inner ear port of FIG. 11 (implant 1100), comprising a tissue interface portion (e.g., body 1110) configured for securement to tissue of and/or proximate an inner ear of a human and provide a passage from outside the inner ear to inside the inner ear. In this embodiment, the tissue interface portion has a longitudinal axis (e.g., axis 889). A surface (the surface at the end of section 1630 that is normal to the longitudinal axis and/or has an angle A3 noted above, and in the embodiment of FIG. 17, surface 1710) of the tissue interfacing portion that directly interfaces with tissue and/or indirectly interfaces with tissue (in the case of bone cement / adhesive being located on the surface) when the tissue interface portion is secured to the tissue is more normal than parallel to the longitudinal axis (thus less than 135 degrees). In an exemplary embodiment, the surface is located at a face is located at a distal section of the tissue interface portion. In an exemplary embodiment, the surface is located, with respect to a distalmost portion of the device, at location(s) that are less than and/or at 40, 35, 30, 25, 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, or 5%, or any value or range of values in 0.1% increments of the total length of the device from the distal end. The surface can be located between the aforementioned planes spaced as detailed above where the most distal plane is located less than and/or at any one or more of the aforementioned percentage based positions. And note that “surface” is used herein as a proxy for a disclosure of one or more surfaces. That does not mean that surface means 1, 2, or more. That means that in the interests of textual economy, when we disclose one we disclose the plurality of surfaces of 17A as well unless otherwise noted providing that the art enables such.

[00106] In an exemplary embodiment, all of these surfaces are more normal than parallel to the longitudinal axis. In an embodiment, there is one surface, and the surface is substantially normal to the longitudinal axis.

[00107] With respect to the distal end of the device, as seen above, the distal end can be established by an extension portion of the device (portion 1520 as shown in FIG. 16) that extends away from the surface in the direction of the longitudinal axis, which distal end extends into the inner ear cavity when the device is fully secured to the tissue. In an embodiment, the extension portion is coaxial with an outer periphery of the tissue interface (again, in some embodiments, the body of the implant is rotationally symmetrical about the longitudinal axis over 360 degrees thereabout). In an exemplary embodiment, when the device is fully and permanently implanted, the distal end extends at least 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, or 3 mm, or any value or range of values therebetween in 0.01 mm increments from the inner wall of the cochlea from where the portion entered the cochlea. Some additional features of this will be described below with some different ranges / values for an alternate embodiment.

[00108] As seen above, the device can include a component releasably attached to the tissue interface portion (e.g., the plug or cap) and/or a portion of the device supported by the tissue interface portion. The device is configured to enable the component to be removed from the tissue interface portion when the tissue interface portion is removably permanently fixed to a barrier establishing the inner ear of a human. The component at least partially seals the passage (which includes totally seals in some embodiments).

[00109] With respect to the implanted device, the tissue to which the interface is attached is, with respect to an inner ear port, bone establishing a barrier of the inner ear of the human. Also, the device is releasably permanently attached to the barrier establishing the inner ear of a human.

[oono] In this regard, some exemplary embodiments are directed towards a body that is configured to permanently fix to an opening in the barrier between the middle ear in the inner ear of a human. By “permanently fix,” it is meant that the body can remain in the human for at least a year, if not longer, such as, for example, any one or more of the aforementioned longer temporal periods that will be discussed below at the location that it is implanted at the time of implantation. This as distinguished from, for example, a temporary component / a temporary port, that might be utilized for only a few hours or a few days or a few weeks after implantation, and/or a device that could dissolve or degrade owing to the fluids of the body, or otherwise has a reliability engineering design such that functionality is likely to degrade to an un-functional state in a statistically significant number of designs.

[oom] And there is a middle ground, for example, where the device is configured to be “healed out” of the cochlea wall, for example. For example, the port could be designed to be pushed out by reforming bone after a few months or more (say after 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 or more months). And note that this could be a scenario where the port is configured or otherwise of the design to be permanently implanted vis-a-vis the temporal periods detailed herein with respect to the mere ability to stay implanted without causing a deleterious effect on the human, but where the application thereof results in healing out of the port. But the design of the port can be configured for such result as well. That is, the port can be configured to have a shape for example that will result in the healing out of the port based on normal bone regrowth. To be clear, the two designs are not mutually exclusive to each other. The material and/or the design of the port can be configured to satisfy the longevity requirements, even though the device is not utilized for such long temporal periods.

[00112] Any reference to the features associated with longevity / permanence of the body are also applicable to one or more or all of the other components / portions of the port device unless otherwise noted, providing that the art enables such. [00113] The fixation can be established by any of the regimes detailed above or below in an exemplary embodiment, the body is made of a material that osseointegrates to the bone, and thus in some embodiments the body is osseointegrated to the bone to achieve the aforementioned permanent fixation.

[00114] The port device of the embodiments of the teachings herein are configured to enable resealable physical access from the middle ear cavity 106 into the inner ear 199 (see FIG. 11 for example) through the passage through the port device 1100 (whether after the plug / cap is removed, or through the septum, etc.). In an exemplary embodiment, the port device 1100, etc., is configured to enable the resealable physical access at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 100, 125, 150, 175, or 200 times or more, or any value or range of therebetween in 1 increment (e.g., 47, 66, 33 to 176, etc.). In an exemplary embodiment, the port device is configured to meet one or more of the aforementioned quantities within 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 100, 125, 150, 175, or 200 weeks, and/or months (or 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, 50, or 60 or more years) from the date of implantation of the inner ear port device into the human. Corollary to this is that there are methods of accessing the port device any one or more of the aforementioned quantities within any one or more of the aforementioned temporal periods.

[00115] In some embodiments, the tissue interface portion has been implanted into bone establishing a barrier between the middle ear and the inner ear for at least any of the times detailed above (e.g., 2 years) and the component (the removable component from the body / tissue interface portion) was implanted for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 or 24 or more months less than the tissue interfacing portion.

[00116] At least some embodiments of the teachings herein enable inner ear access while maintaining cochlear function. At least some embodiments enable smart therapeutic substance delivery to the inner ear. At least some embodiments enable smart therapeutic substance delivery to the eye system, such as the eye shown in FIG. 4A (in an exemplary embodiment, the port devices can be implanted in an eye bone / skull bone proximate the eye and/or the nerves extending from the eye(s), and thus some embodiments can be an eye prosthesis). Some embodiments can enable implantation of such devices in the eyeball by pushing through to the vitreous humor. Accordingly, any disclosure of interfacing with an inner ear and/or providing therapeutic substance thereto and/or sensing phenomena thereof, etc., corresponds to an alternate disclosure of interfacing with body tissue associated with and/or proximate the eye(s) and/or optical nervous system, for purposes of textual economy.

[00117] In some embodiments, the surface of the tissue is located in an artificial excavation extending below an outer profile of the barrier on a middle ear side of the barrier (again, see for example FIG. 11 - additional details of this will be described below). Also, the artificial excavation extends a distance below the outer profile so that the surface of the tissue interfacing portion is directly and/or indirectly interfacing with the bone establishing the barrier of the inner ear of the human.

[00118] As seen in the embodiment of FIG. 11, etc., with respect to an interior of the inner ear, the device is minimally invasive while having a component extending fully into the interior of the inner ear. This as contrasted to a cochlear implant, for example.

[00119] Embodiments include a roughened axial surface to enhance osteointegration and/or bone cement / adhesive adhesion. Embodiments can include a microroughened surface and/or a laser scored surface. Moreover, as seen in FIG. 17B, an exemplary port 17B includes a body 1710A that includes dovetail hollows 1777 in the axial surface, which hollows can be at least partially filled with bone cement that when cured / hardens, creates an interlocking feature.

[00120] The above said, the surface can be a grinder surface and/or a cutting surface. In an embodiment as will be described below, the body 1110 of the port can be used to grind and/or cut the excavation in the bone. The surface can be a roughened surface that enables the grinding of the bone. Alternatively, and/or in addition to this, the surface can be a cutting surface, where the angled cutting surface thereof can be used in a manner analogous to the dovetail hollows 1777 to lock the bone cement to the body 1110. (The grinder surface can function in an analogous manner to the above described roughened surface.)

[00121] In an embodiment, by rotating the entire device, we obtain a “perfect” (or essentially perfect) match for the bored hole, and this can be achieved by grinding. In an embodiment, the grinding surface is a rough surface. The grinding can leave a roughened surface that enhances bone cement grip / adhesive grip relative to that which would be the case with a cut surface. Indeed, in an embodiment, the side(s) of the tool can be grinding surfaces or at least rough surfaces and/or have discontinuities so as to roughen the sides of the excavation as the tool bores into the bone, which can have utilitarian value if adhesive / bone cement is to be used on the lateral side, thus also enhancing the bond / grip with the bone. [00122] Note a lubricant an/or a cooling medium can be provided to the surface(s) and/or a body in thermal conductivity with the surface, and cooling with this medium can be executed.

[00123] In an embodiment, surface roughness of the grinder can be less than and/or equal to 30, 25, 20, 15, 10, 5, 4, 3, 2, 1, 0.75, 0.5 or 0.25 10' ⁶ m or any value or range of values therebetween in 0.01 0.25 1 O' ⁶ m increments.

[00124] In an embodiment, all flatness of the bone is a result of and/or due to the flatness of the working surface of the boring tool.

[00125] FIGs. 18 and 19 present exemplary schematics of exemplary artificial excavations according to some exemplary embodiments. Figure 18 presents a first artificial excavation 1810 that shows an excavation without a breakthrough into the inner ear cavity 199. This occurs in a second step in some embodiments separate from establishing the excavation 1810. Figure 19 depicts the breakthrough passage 1820, where the name does not require “breaking” of the bone, although some embodiments include actually doing such to create passage 1820. The “breakthrough” is the final portion of the passage that establishes a passage from excavation 1810 to 199.

[00126] That is, embodiments include two separate actions of establishing respectively different excavations / hollow portions in the barrier between the middle ear cavity and the inner ear cavity. The idea is that by establishing a tiered passageway, such as that shown in figure 19, where the passageway portion closest to the inner ear cavity 199 has an outer diameter that is smaller than the outer diameter of the port (and thus the outer diameter of the excavation 1810), the port cannot pass all the way through into the inner ear cavity 199 and also the bone that remains that establishes the passage 1820 provides a bone surface for the axial face of the port.

[00127] The features of the passage(s) will now be described in terms of methods. FIG. 20 presents an exemplary flowchart for an exemplary method, method 2000, which includes method action 2091, which includes the action of obtaining access to a middle ear cavity of a human. In an embodiment, this can be executed through a tympanic membrane (in some embodiments, this is done without using an endoscope - additional details of this will be described below, but briefly, in some embodiments, an endoscope is used, while in other embodiments and endoscope is specifically not used owing to the nature of the tools and/or the ports that are utilized herein- more on this below). This could be executed using a tool detailed below that has a termination that can minimally invasively extend through the tympanic membrane, or another variation thereof.

[00128] Method 2000 includes method action 2092, which includes the action of removing a quantity of tissue of a barrier between the middle ear and an inner ear cavity of the human. This can be executed by grinding and/or drilling, and by using a grinder or drill as shown below. The quantity of tissue removed establishes, for example, the excavation 1810 of FIG.

18. (As will be described below, an additional quantity can be removed to establish the passageway into the inner ear. More on this below.)

[00129] In an embodiment, method action 2092 is executed by rotating a boring tool, such as a grinding boring tool, about its longitudinal axis, wherein the boring tool is held constant in the lateral direction and/or at least substantially constant in the lateral. This as opposed to moving the surface laterally to “widen” the bore beyond that which would result from a “straight shot” into the bone. In an embodiment, the method is executed so that the longitudinal axis of the tool as measured at the location of the surface of the bone upon the entire outer diameter grinding to below grade (so that there is sidewall all about the tool, even if only a few microns - something that is measurable), does not move out of a circle normal to the longitudinal axis at that point that is no more than 0.7, 0.6, 0.5, 0.4, 0.3, 0.2, 0.1 or 0.05 mm in diameter or any value or range of values therebetween in 0.01 mm increments (this is the limits of lateral motion).

[00130] Method 2000 further includes method action 2092, which includes the action of removably permanently fixing a cochlear access port at an area of the removed quantity of tissue. In method 2000, the removed quantity leaves a portion of the barrier intact directly beneath the area of the removed quantity of tissue, and the port is placed directly above the portion of the barrier that is intact. The portion that is left can be portion 1830 shown in FIG.

19. That is, the removed quantity leaves a portion of the barrier intact, with respect to a longitudinal axis of the port treated as being in a vertical direction (that does not mean that the axis is vertical, this is simply a local frame of reference - the method could be executed with the axis being horizontal, or vertical, or oblique to the direction of gravity, essentially, rotate the view of FIG. 11 clockwise 90 degrees to establish the frame of reference), directly beneath the area of the removed quantity of tissue, and the port is placed directly above the portion of the barrier that is intact. [00131] In an exemplary embodiment, method action 2092 is executed by a surgeon holding a drill or grinder with one hand and only one hand, for at least and/or equal to 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100 percent of the depth of drilling or any value or range of values therebetween in 1% increments.

[00132] Any device, system, and/or method of establishing the passage through the tissue can be utilized in at least some exemplary embodiments.

[00133] In an embodiment, any one or more of the method actions herein is repeated over a number of different humans, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 times or more or any value or range of values in 1 increments within 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 months and/or years or any value or range of values in 1 increments at the same health care facility and/or by the same health care professional and/or under the supervision of the same healthcare professional and/or by and/or under the supervision of the same healthcare providing entity. Embodiments include remote surgery, hence under the supervision (this can also include a non-surgeon at a healthcare facility executing one or more of the method actions under the supervision of another entity

[00134] In an exemplary embodiment, D19 (where for example excavation 1810 has a circular cross-section) is less than and/or equal to 6.5, 6, 5.5, 5, 4.5, 4, 3.5, 3, 2.5, 2, or 1.5 mm or any value or range of values therebetween in 0.01 mm increments. In an embodiment, D19 is no more than or greater than or equal to 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3, 0.2, or 0.1 %, or any value or range of values therebetween in 0.01% increments greater than the value of DI. In an embodiment, D19 is greater than, less than and/or equal to 2, 1.9, .18, 1.7, 1.6. 1.5, 1.4, 1.3, 1.2, 1.1, 1.0, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3, 0.2, 0.1, 0.09, 0.08, 0.07, 0.06, 0.05, 0.04, 0.03, 0.02, or 0.01%, or any value or range of values therebetween in 0.005% increments larger or smaller than DI. In this regard, D19 could be sized to have an interference fit with the outside diameter of the body 1110. D19 could be sized to permit space for adhesive / bone cement. In an embodiment, the diameter (maximum inner diameter) of excavation 1820 is less than and/or equal to 75, 70, 65, 60, 55, 50, 45, 40, 35, 30, 25, 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, or 5%, or any value or range of values therebetween in 0.1% increments of the value of DI 9. In some embodiments, the maximum inner diameter is less than and/or equal to 1.5, 1.4, 1.3, 1.2, 1.1, 1.0, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3, or 0.2 mm, or any value or range of values therebetween in 0.025 mm increments. Lower values can be used for drug delivery, for example. An embodiment includes delivering drugs / therapeutic substances using the port where the diameter is

[00135] In an embodiment, the minimum height of the sidewall of excavation 1810 (owing to the fact that the barrier between 106 and 199 is not perfectly planar, one side can be higher than the other) D9 is greater than, less than, and/or equal to 100, 125, 150, 175, 200, 225, 250, 275, 300, 350, 400, 450, 500, 550, 600, 650, 700, 750, 800, 900, 1000, 1250, 1500, 1500, 1750 or 2000 microns or any value or range of values therebetween in 1 micron increments (these numbers will vary depending on inter human variability, and it might be that 2000 microns is a very extreme / unlikely scenario). And note that the depth of the excavation 1810 can be measured from the tangent plane of the outer surface of the barrier between the middle ear and the inner ear prior to excavation where that tangent plane bisects the longitudinal axis 1889 of the ultimately drilled or ground excavation 1810. This is shown as dimension D7 in FIG. 19. D7 can be any of the values of D9 noted above (D7 need not be the same as D9, this is presented in terms of textual economy).

[00136] As can be seen, in an exemplary embodiment, the longitudinal axis of the excavations 1889 need not be perfectly normal to the tangent plane of the surface of the bone at the point where the axis extends through the barrier. In an exemplary embodiment, the longitudinal axis extends at an angle of equal to or less than 90, 95, 80, 75, 70, 65, 60, 55, or 50 degrees or less or any value or range of values therebetween in 1° increments relative to the tangent plane on the surface of the bone at the point where the longitudinal axis extends in the bone. Note also that the affirmation values can be measured from an average tangent plane that is the average over the area that will be excavated. The average can be the mean median or mode.

[00137] A minimum thickness of the portion of the barrier 1830 can be greater than, less than, and/or equal to 250, 275, 300, 350, 400, 450, 500, 550, 600, 650, 700, 750, 800, 900, 1000, 1250, 1500, 1500, 1750, or 2000 microns, or any value or range of values therebetween in 1 micron increments.

[00138] It is noted that the values for DI 9, D9, and D7, and the inner diameter of 1820, and the thickness of the barrier, can be average values (mean, median and/or mode) for the excavations.

[00139] The “bottom” surface of excavation 1810 (surface 1840) can be a surface that in its entirety (all within the sidewall) falls within two parallel planes that are normal to the axis 1880 that are within 25, 50, 75, 200, 225, 250, 275, 300, 325, 350, 375, 400, 450, or 500 microns, or any value or range of values therebetween in 1 micron increments.

[00140] In an embodiment of the method 2000, the portion of the barrier that is intact (element 1830) extends a majority of the distance from one side of the area of the removed quantity to an opposite side of the area of the removed quantity from the one side (here, the removed quantity is the excavation 1810). In an embodiment, the total area of a circle on a plane that is completely within excavation 1820 and is perpendicular to the axis 1889 is less than and/or equal to 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, or 5%, or any value or range of values in 0.1% increments of the total area of a surface on a plane normal to axis 1889 that is completely within excavation 1810 (which would be a circular area where excavation 1810 is bored using a circular grinder with only negligible movement in the lateral direction, if any).

[00141] In an exemplary embodiment, 1810 is concentric with 1820 within 25, 50, 75, 200, 225, 250, 275, 300, 325, 350, 375, 400, 450, or 500 microns, or any value or range of values therebetween in 1 micron increments. In an embodiment, the circular cross-section of a surface on a plane normal to axis 1889 that is completely within excavation 1810 has a circularity of better than 25, 50, 75, 200, 225, 250, 275, 300, 325, 350, 375, 400, 450, or 500 microns. In an embodiment, the total surface area of the sidewall of 1810 has a circularity better than 25, 50, 75, 200, 225, 250, 275, 300, 325, 350, 375, 400, 450 or 500 microns (the sidewall all falls within two concentric cylinders spaced apart by those values).

[00142] In an exemplary embodiment, the portion of the barrier that is intact (1830) extends at least 50, 55, 60, 65, 70, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94 or 95 percent or any value or range of values therebetween in 0.1% increments of the distance from one side of the area of the removed quantity (1810) to an opposite side of the area of the removed quantity from the one side.

[00143] In an embodiment, the action of removing the quantity of tissue is a first action of removing a first quantity of tissue that results in a complete layer of tissue preserving the barrier between the middle ear and the inner ear (this can be the result seen in FIG. 18). Further, the method further comprises, after the action of removing the first quantity, separately removing a second quantity of tissue (e.g., the passageway 1820) substantially smaller than the first quantity. In an embodiment, this is executed using a different removal surface than that which was used to remove the first quantity. In an exemplary embodiment, a first drill or grinder is used to establish excavation 1810, and a second drill or grinder separate from the first is used to establish excavation 1820. In an embodiment, the drill or grinder is a compound drill or grinder, and the surfaces are separate (as distinct from a surface that continues from one zone to the other). In an exemplary embodiment, a chipping tool is utilized to break through from the removed quantity 1810 to the cavity 199, whereas a grinding tool or a drill bit is utilized to establish the excavation 1810. In an exemplary embodiment, the distal protrusion of the port is what is utilized to break through to the cavity 199 after the drill bit with a grinding tool is utilized to establish the excavation 1810. Indeed, in an embodiment, a “sharp” distal protrusion can be present, such as shown in FIG. 12A. This can create a high pressure point to focus the initiation of a crack or a fissure in the bone. In an embodiment, the body 1110 can be rotated so that the sharp portion scores the bone in a circle or a semi-circle to preform the break area. The body can be rotated over and over to score all the way through or substantially all the way through to the interior of the cochlea (or until the bone breaks away from the circular scoring). The end can be as sharp as a syringe termination for piercing the skin, or can be 50 percent of the sharpness, or 25 percent of the sharpness thereof, or anything in between in 1% increments. Indeed, as shown in FIG. 12 A, the angle established by portion 15222 at the distal end is not as oblique as a syringe termination. In an embodiment, the angle that the forward surface extends away from a plane normal to the longitudinal axis is greater than or less than or equal to 30, 35, 40, 45, 50, 55, 60, 65, 70, or 75 degrees or more (or less in some other embodiments), or any value or range of values therebetween in 1 degree increments.

[00144] In an exemplary embodiment, on a per unit volume and/or per unit mass basis, the second quantity of tissue is less than and/or equal to 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 34, or 40%, or any value or range of values therebetween in 0.1 % increments of the first quantity of tissue (the second quantity is excavation 1820 and the first is excavation 1810 in this exemplary embodiment).

[00145] FIG. 21 depicts a boring device 2100 configured to bore the first excavation 2100. Here, there is shank 2130 that is connected to or integral with the material removal portion 2120. Element 2120 can be a circular plate or cylinder. The distal end of element 2120 has a roughened surface 2140 that is configured to grind the bone or otherwise the tissue establishing a barrier between the middle ear and the inner ear. In this exemplary embodiment, the boring device 2100 is rotationally symmetric about the longitudinal axis 2189. The cross-sections of the boring device are circular and centered about the longitudinal axis 2189. The face at the most distal end is normal to the longitudinal axis in the embodiment shown here, and thus could correspond to angle A2 detailed above with respect to the port body. However, in other embodiments, the face at the most distal end can be angled at an angle different than 90° from the longitudinal axis. In the interests of textual economy, the end faces / the faces that establish the working surface(s) that bores through the bone can have any of the angles A3 detailed above with respect to the port. Indeed, in an exemplary embodiment, the end faces / the faces that establish the working surface(s) that bores through the bone can have any of the angular arrangements detailed above with respect to the surface(s) of the port that will interface with the resulting surface(s) of the excavation 1810. In some embodiments, they will be the same (a surface of the port will correspond to the surface of the device 2100 that ground the ultimate interfacing surface). In some embodiments, the surfaces may be different (e.g., A3 of a surface of the port could be 95 degrees and A3 of the surface of the grinder could be 94 degrees, for example). Still, in some embodiments, the idea is that the resulting surface(s) in the bottom of the excavation 1810 will correspond to the ultimate mating surface(s) of the tissue interface portion of the port. Indeed, as will be described below, in some embodiments, the port body has a grinding surface that is used to grind the excavations.

[00146] It can thus be seen that embodiments include establishing one or more of the excavations without using a burr drill. Indeed, embodiments can include establishing the excavation(s) without using a cutting drill. Embodiments include using only grinding.

[00147] To be clear, embodiments include executing an entire medical procedure including obtaining access to the middle ear, establishing the excavations to reach the inner ear, and placing the port prosthesis therein, all without utilizing a burring drill and/or a cutting drill to excavate bone. In an exemplary embodiment, all excavations utilized to establish the passageway from the middle ear to the inner ear are executed without burring and/or without utilizing a cutting drill. In an embodiment, all excavations utilized to establish the passageway from the middle ear to the inner ear are executed utilizing grinding. The working end of the tool 2100 / element 2120 has an outer diameter D201 which can correspond to any of the diameters DI noted above (they need not be the same - this is presented in a manner for textual economy). D201 can be any of the values of D19, and again, they need not be the same. In an embodiment, there could be some undersize of D201 relative to D19 (or visa- versa) owing to phenomena associated with the interaction of a boring component with tissue (the tissue could “collapse” slightly after the action of boring is completed, or a slightly larger diameter of the excavation could result). [00148] As seen in FIG. 21, the device 2100 has a passageway 2150 extending from the proximal end to the distal end and is open at both ends.

[00149] The diameter of the passageway 2150 (which can have a circular cross-section) can be D202, which can be less than, and/or equal to 50, 60, 70, 80, 90, 100, 125, 150, 175, 200, 225, 250, 275, 300, 350, 400, 450, 500, 550, 600, 650, 700, 750, 800, 900, 1000, 1250, or 1500 microns or any value or range of values therebetween in 1 micron increments (it can be bigger as well). The utility of this will be further explained below, but briefly, the passageway 2150 enables a test sensor to be inserted through the passageway (or enables a second boring tool to be inserted, which second tool can be used to bore the second excavation 1820 (or chip away at the remaining bone to establish the second excavation 1820)).

[00150] Device 2100 can be made of titanium or of stainless steel. The shank 2130 is sized and dimensioned to interface with a standard drill motor, in some embodiments.

[00151] FIG. 21 A depicts another exemplary boring device 2100 A configured to bore the first excavation 2100. Here, the shank is indistinguishable from the removal portion 2120A. In this exemplary embodiment, the boring device 2100A is rotationally symmetric about the longitudinal axis 2189. The utility of this will be described below.

[00152] FIG. 23 shows another exemplary boring tool 2300. Here, element 2140 can correspond to that of the tool shown in figure 21 for example. But as shown, there is an extension portion 2320 that includes cutting edges 2322 at the distal end thereof. This extension portion 2320 is utilized to establish the second excavation 1820. In this regard, in an exemplary embodiment, the first excavation and the second excavation can be established utilizing the same tool and can be established at the same time (in that the final form of the first excavation is established at the same time as the final form of the second excavation). The outer diameter D221 of the extension portion 2320 can have any of the values of the portion 1520 of the body 1110 described above (again, this is presented in this manner in the interests of textual economy - the values need not be the same).

[00153] As noted above, the extension portion has cutting edges 2322. This is distinguished from the grinding surface 2140. In this regard, cutting edges 2322 are akin or otherwise the same as the cutting edges of a drill bit. It is noted that in an alternate embodiment, a grinding surface can instead be utilized at the location of the cutting edges 2322. Corollary to this is that instead of the grinding surface 2140, cutting edges can be utilized at those locations. In this regard, tool 2300 and/or 2100 can be a grinder or a drill bit or combination thereof.

[00154] FIG. 22 depicts an example of the utilization of the utility of the passageway through the tool 2100. Here, a sensor probe 2250 in signal communication with meter 2230, which can be a voltage meter for example or a multimeter for example, can be passed through the passageway in the tool 2100. The sensor probe 2250 can include an electrode, such as an electrode located at the end of the probe. As shown in figure 22, sensor probe 2240 is also in signal communication with meter 2230. The sensor probe 2240 shown positioned against the round window 121, while in other embodiments, it can be positioned to abut the oval window, or any other location that can have utilitarian value. The sensor probe 2250 is inserted through the passageway in the tool 2100, and if the end of the sensor/the electrode of the sensor is in contact with the perilymph located in the cavity 199, with the sensor probe 2240 located against the window 121, a potential difference in voltage can be measured or otherwise will be registered by / at the meter 2230 indicating that the distal end of the sensor probe 2250 has penetrated into the cavity 199, and thus a passageway from the middle ear into the inner ear has been established.

[00155] The sensor probe 2250 is shown as having a wedge shaped electrode 2222. This can have utilitarian value with respect to providing dual use of the sensor probe 2250 so that the sensor probe 2250 can be utilized to chip through the remaining portion of the barrier between the middle ear and the inner ear to establish passageway 1820A. Unlike the more defined excavation portion 1820 shown in the above figures, passageway 1820A (which can also be considered an excavation even if chipping is used to establish the passageway), is more arbitrary in configuration (because it is established by chipping for example). In this exemplary embodiment, the tool 2100 can be utilized to establish the excavation 1810, to a level where the chipping tool can be utilized to breakthrough to the cavity 199. By establishing the electrode 2222 as a chipping component as well, dual use can be achieved. Note also that in an alternate embodiment, a separate chipping tool can be utilized. That is, a tool that is designed solely as a chipping device can be utilized to establish the passageway 1820A and then a separate sensor probe with a dedicated electrode can be utilized to verify that indeed a passageway has been established to reach the perilymph.

[00156] Thus, it can be seen that in some embodiments, the device includes a relevant environment exposed sensor component (e.g., the electrode) of an electrical phenomenon sensor. By relevant environment exposed sensor, it is meant the electrode(s) as opposed to the leads or other parts, which are not exposed to the environment, at least do to the shielding / insulation) of the electrical phenomenon sensor (where the sensor can include the electrodes, the leads, and the electronics package of the meter, where the leads 842 are in electrical communication with the cable and thus the electronics package). In some embodiments, the electrical phenomenon sensor is configured to sense impedance and/or a change in impedance and/or a phenomenon that results from a change of impedance. The impedance being between the at least a relevant environment exposed sensor component and another component of the sensor (e.g., the electrode on the round window). Here, this could be the impedance between the two electrodes. This can also be the impedance between electrode, and a common ground, which common ground could be the boring tool, where there is some form of high impedance between the two.

[00157] And while electrodes are envisioned in the embodiment shown in figure 22, in other embodiments, other types of sensor probes are utilized, such as chemical sensors and/or optical sensors and/or density or gradient sensors, etc.

[00158] Thus, embodiments include a device that has a sensor component that includes an electrical phenomenon sensor that includes at least one electrode (some can include 2, 3, 4, 5, 6, or more electrodes). Also, the device can include a probe movably extending through the hollow, the probe supporting the sensor component.

[00159] In view of the above, embodiments can include a device comprising an apparatus including a bone cutting and/or grinding surface and/or chipping surface, such as those variously detailed above. The bone cutting surface can be a drill bit or a drill bit like surface, and the grinding surface can be a rough surface for grinding, concomitant with grinding surfaces, at least grinding surfaces configured to grind human bone. The chipping tool can be a sharp edge / point (but could be a semi-blunt surface - a dull edge that does not cut but can be used to apply pressure in a limited area). The principle of operation of a chip is the application of pressure as opposed to cutting or grinding (even though there is pressure applied in those methods). Also as seen above, the apparatus includes a hollow passage extending completely from a proximal end of the apparatus to a distal end of the apparatus to the surface, creating an opening in the surface (in some embodiments, there is no passage). The device is a cochleostomy establishment device. This means that it is a tool that is designed and instructed specifically for establishing a cochleostomy. In an exemplary embodiment, the product is packaged with or is internet-linked to instructions, etc., instructing that use is for a cochleostomy (or other such language - a device for establishing an artificial passageway through the bone that establishes the barrier between the middle ear cavity and the inner ear). The device can be a U.S. Food and Drug approved device (which is the case for all of the devices herein) for the specific use. In some embodiments, the cutting and/or griding surface has a maximum diameter of less than 6, 5, 4, 3, 2 or 1 mm or any value or range of values therebetween in 0.1 mm increments. In some embodiments, the opening in the surface has a maximum dimeter of less than 1, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3, 0.2, 0.1, 0.05, 0.025 mm, or any value or range of values in 0.005 mm increments.

[00160] In an embodiment, the device is different from a so called ball drill. In an embodiment, the working surface is devoid of diamond crystals or the like. In an embodiment, the working surface is devoid of cutting surfaces / edges.

[00161] In an embodiment, the apparatus includes a subcomponent located in the hollow, at least partially blocking the opening at the distal end, the subcomponent having a respective bone cutting and/or grinding surface, the subcomponent being removable from the rest of the apparatus. In this regard, FIG. 24 depicts another exemplary device, device 2400, which is a combination of a port body 1110 with a grinding surface 2140 as shown and a drill bit 2410 with cutting edges 2322 at the distal end thereof. This is an exemplary embodiment where the port body 1110 can be utilized to bore the excavations in the barrier between the middle ear and the inner ear by rotating the port body 1110 in a manner akin to how the grinding tool would be rotated. In an exemplary embodiment, the port body can be locked about the longitudinal axis with the drill bit 2410 so that rotation of the drill bit will also cause equal rotation of the port. This can be established by a key slot or the like in the protrusion of the distal portion of the port body 1110 that interfaces with a key on the drill bit 2410. The key slot can be configured to enable the drill bit 2410 to the moved in the longitudinal direction so that the port body can be slid off the drill bit. However, while the embodiment of figure 24 depicts the utilization of a port body modified with a grinding surface 2140 (or a cutting surface in an alternate embodiment) in combination with the drill bit 2410, other embodiments can utilize the drill bit 2410 or a variation thereof with the tools 2100 and 2300 presented above providing that the drill bit 2410 is sized and dimensioned to fit in the passageway of the tools.

[00162] Embodiments include using drill bit 2410 as a pilot. In an embodiment, drill bit 2410 is first used to drill through the promontory, and then the boring tool 2100 for example is fit over the drill bit and the drill bit is used as a guide for the boring tool (this embodiment can dispense with the keying to permit the boring tool to rotate about a fixed drill bit (this can also be the case with the combined port / grinder)). Drill bit 2410 can have a sensor device and can be configured to enable sensing of perilymph, such as with meter 2230 and the accompanying components. Indeed, in some embodiments, drill bit 2410 is used as an electrode (a lead is attached to the end of the drill bit, which lead is connected to the meter 2230).

[00163] In an embodiment of the method 2000, the action of removing the quantity of tissue is a first action of removing a first quantity of tissue (the first quantity is the excavation 1810) and the method further comprises, before the action of removing the first quantity, separately removing a second quantity of tissue substantially smaller than the first quantity using a different removal surface than that which was used to remove the first quantity, wherein the second quantity of tissue removed opens a path from the middle ear to the inner ear (the second quantity can be the pilot hole). The method can thus also include using the hole established by removing the second quantity as a pilot hole when executing the first quantity. And while embodiments have focused on utilizing the drill bit utilized to establish the pilot hole as a pilot (thus using the hole as a pilot hole, albeit indirectly), in an alternate embodiment, the boring tool can have a non-cutting pilot body there on that interfaces with the pilot hole so as to center the boring surface about the pilot hole.

[00164] Note further that the protrusion of the distal portion can also include a cutting and/or grinding surface, as shown in FIG. 24.

[00165] Also, in some embodiments, it could be that it is only the port that has the portion that grinds and/or cuts through for the second excavation. In this regard, FIG. 25 shows a port device 2500 that has a body 2510 that has a grinding surface 2522 on the distal end thereof. Note that the grinding surfaces and/or cutting surfaces can be monolithic with the component that supports such in some embodiments, and in other embodiments, there can be a separate component that is attached to the support structure - this is the case with respect to the embodiment of figure 25 and the other embodiments detailed herein - here, the grinding surface 2522 is monolithic with the structure that establishes the section 1620, but this could be a grinding pad that is welded or otherwise secured to the body 2510 of the port. The body (cylinder) that establishes the section 1620 is thick- walled as shown so as to provide a larger surface area at the distal end thereof relative to the body 1110 detailed above (at least as presented pictorially) to provide a comparable large grinding surface. The interior passage can have a relatively narrow diameter as detailed above so that the passageway results in a de minimis reduction in grinding surface area. [00166] In an exemplary embodiment, the wall thickness of section 1620 of the embodiment of figure 25 can be less than, and/or equal to 30, 40, 50, 60, 70, 80, 90, 100, 125, 150, 175, 200, 225, 250, 275, 300, 350, 400, 450, 500, 550, 600, 650, 700, 750, 800, 900, 1000, 1250, or 1500 microns, or any value or range of values therebetween in 1 micron increments (it can be bigger as well).

[00167] Thus, embodiments can include a boring device that is a cochlea access port configured for permanent implantation to provide permanent resealable access from a middle ear to a cochlea. In an embodiment, the port is utilized to bore the excavation, which dimensions of the excavation would have the dimensions that would be utilitarian with respect to the dimensions of the port owing to the fact that the port was utilized to bore the excavation, and in the port can be removed from the excavation, and bone cement or adhesive or the like can be applied to the pertinent surfaces, and then the port can be reinserted into the excavation so as to releasably permanently implant the port at the barrier between the middle ear and the inner ear.

[00168] In an exemplary embodiment, there can be a slight outward taper with respect to the outer wall of the port body with respect to location along the longitudinal axis from the distal end towards the proximal end for at least a portion of the body so that the port body wedges into the excavation 1810 so as to interference fit the body therein. In an exemplary embodiment, the grinding surface 2140 does not extend all the way to the outer periphery and thus the outer diameter of the excavation will be slightly smaller than the outer diameter of the body (this could be an undersize of a ten thousandth of an inch for example). Thus, the body may not have the outward taper to establish the interference fit. The interference fit can be utilized with or without the adhesive in at least some exemplary embodiments. In some embodiments, there is no adhesive, and instead the interference fit is what is utilized to secure the port. In some embodiments, there is only adhesive and no interference fit is utilized. As noted above, in an exemplary embodiment, the securement of the port to the bone is screwless.

[00169] FIG. 26 shows another exemplary embodiment of a port device 2600 that includes a body 2610 that includes a grinding surface 2140 and a grinding surface 2522 is shown. In an embodiment, the body 2610 is a metal disk, such as a titanium or carbon steel disk. In this embodiment, the port device 2600 can be mounted to a drill motor otherwise connected to a drill motor (or some other powered rotating device (in some embodiments, it can be a hand turned device)) to rotate the body 2610 so as to rotate the grinding surfaces and thus grind the excavations to establish the passageway through the barrier between the middle ear and the inner ear. In an embodiment, an interior and/or an exterior surface of the wide portion of the body 2610 can have a key and/or a slot extending in the longitudinal axis direction which can interface with a comparable interfacing device of the drill motor other rotating device so as to enable the transfer of torque from the drill motor to the port body.

[00170] Note further that in an embodiment, such as where the body 2610 is made out of an electrically conductive material, the port body 2610 can be utilized as the probe 2250 in the arrangement of figure 22 to determine whether or not the port body twenty-six ten is in contact with the perilymph.

[00171] The outer diameter D221 of the extension portion 2320 can have any of the values of the portion 1520 of the body 1110 described above (again, this is presented in this manner in the interests of textual economy - the values need not be the same).

[00172] In an exemplary embodiment, the grinding / cutting surface establishes a tangent plane that lies on an angle A3 (the tangent plane can be measured from the theoretical / extrapolated extension of the roughened surface / cutting surface to address the fact that the surface will be locally non flat). For example, surfaces having a tangent plane that is on that angle. In an exemplary embodiment, the surface falls within two parallel planes that are within 1, 0.75, 0.5, 0.25, 0.1, 0.09, 0.08, 0.07, 0.06, 0.05, 0.04, 0.03, 0.02, 0.01 mm or less, or any value or range of values therebetween in 0.005 mm increments, the planes lying on the angle A3 and/or falling within the angle A3 relative to the length of the surface.

[00173] To be clear, in the interest of textual economy, any of the features of the surfaces associated with the port body and/or the cavities / excavations made in the bone can correspond to the surfaces of the tools 2100 and 2300, etc., and vice versa. The tools described herein are utilized to make the excavations, and the port is designed to fit within the excavation, and be secured therein in a removably permanent manner. Thus, any of the features associated with one can be applicable to the other, although the cavity would be the mirror image for the negative of the port and/or the tools (at least the working surfaces thereof). That said, there can be variations between the surfaces of the port and the tool and the excavations owing to tolerancing and/or fitting regimes or otherwise features that result from the implementation of the technology as it relates to establishing an excavation in the bone and/or implementing a grinding or cutting tool that makes that excavation and/or placing a male component into an excavation as would be understood by the person of ordinary skill in the art. For example, a drill bit has a nominal diameter but the resulting hole drilled by that drill bit can be different. Thus, some embodiments include features of the surfaces that are effectively the same and/or substantially the same which can include the same but need not necessarily be exactly the same owing to these variations.

[00174] FIG. 27 depicts an end view of the boring tool of the embodiment of figure 21 showing that element 2120 is circular in cross-section /with respect to the end view. Figure 28 depicts an alternate embodiment where the working end of the boring device is bifurcated into two separate surfaces 2841 and 2842 as shown, which surfaces are on separate bodies 2821 and 2822 respectively. This embodiment can be considered a propeller like device attached to a shaft 2130 which can correspond to the shaft of the embodiment of figure 21. The bodies 2821 and 2822 (which can be half-racetrack cross-section shaped metal bodies as shown) can be welded to the shaft 2130. An alternate embodiment, there is a single body that is in the shape of a racetrack cross-section which has only one grinding surface. Other arrangements can exist where there are three or four or five surfaces separated from one another (a five bladed propeller like device for example). Thus, there is an embodiment that can include a device where the bone cutting and/or grinding surface is a first bone cutting and/or grinding surface (e.g., with respect to FIG. 28, surface 2841) and there is a second bone cutting and/or grinding surface (e.g., surface 2842), wherein the first surface is spaced away from the second surface relative to axial location about a longitudinal axis of the device. Conversely, with respect to the compound boring tool, there can be a first surface that is angled relative to the second surface (where angled means a non-zero angle value).

In an embodiment of the device of FIG. 28, the bodies 2821 and 2822 can be gimbaled about the shank 2130. This is shown in FIG. 28A. Here, there is a boring device 2800A that includes the grinder bodies 2821 and 2822 that are connected to rod 2888. Rod 2888 can pivot relative to shank 2130 so that the grinder bodies can pivot as represented by the arrows. In an exemplary embodiment, when the torque is applied to the shank 2130, and thus the shank and the grinder bodies rotate, the centripetal force causes the grinder bodies to adopt an orientation that is effectively normal to the shank 2130 (this is analogous to the rotor blades of a UH1 Bell helicopter). In an alternate embodiment, each body is a fully articulated body and thus both bodies can “fold” backwards or forwards, and again the centripetal forces cause the grinder bodies to adopt the normal orientation relative to the shank (this is analogous to the rotor blades of a CH-47D Boeing helicopter). This arrangement can have utilitarian value in that the grinder bodies can pivot to an angle such as that depicted by way of example in figure 28A so that the boring device can fit through a relatively narrow opening, such as an opening in the tympanic membrane and/or such as the passageway in a termination of a tool that is utilized to access the promontory (more on this below). Because the grinder bodies are not perfectly circular but instead are propeller like components, when the grinder bodies are tilted, the effective maximum diameter of the tool is reduced relative to that which would otherwise be the case. For example, if the grinder bodies collectively establish a maximum outer diameter of 5 mm when the grinder bodies are normal to the longitudinal axis 2189 (as shown in FIG. 28 for example), when the grinder bodies are tilted as shown in figure 28A, that maximum outer diameter when measured normal to the longitudinal axis 2189 becomes 3 mm for example (measured in the vertical direction of the format of FIG. 28 A for example). If the grinder bodies are 3 mm wide or less (the direction in and out of the page of FIG. 28 A), this means that the opening through which the boring device 2800A extends need only be maybe 3 mm or 3 and a half mm as opposed to at least 6 mm for example. This opening could be a termination of a tool as will be described below, and/or the opening in the tympanic membrane in a minimally invasive surgical procedure, the apparatus is a bone boring device, wherein the boring surfaces are singularly and/or in combination articulatable relative to the longitudinal axis of the tool so as to reduce a head-on profile in at least one dimension by at least 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65 or 70% or any value or range of values therebetween in 1% increments.

[00175] Embodiments of the bore devices detailed herein can be used as part of an incisor and/or port delivery device, and can be used in combination with a hand-held or a robot held device. In this regard, figure 29 presents an exemplary embodiment of an ear system endoscope 8101. The ear system endoscope is configured to incise through tissue to reach duct(s) of an inner ear of a human and/or deliver a port to the excavation (which may or may not have been made using the endoscope 8101).

[00176] The ear system endoscope 8101 includes various components, such as, an optical channel 8201 which enables data indicative of an image inside the ear system to be conveyed to a location outside the ear system. This can be based on fiber optics or wired communication. Corollary to this is that there is a camera 8221 or some other light capture arrangement (a purely optical device can be used, which may magnify light captured at the working end) that is part of the ear system endoscope, that is in electrical communication or light communication with the optical channel 8201. The optical channel 8201 can be in communication with a display 8261 or some other image conveying device, such as a lens (again, a purely optical system can be used, akin to the output of a traditional microscope, for example). Alternatively, in or in addition to this, the optical channel 8201 can be configured to provide the data indicative of an image via a cable 8011 (or a wireless link, such as a Blue Tooth link) to a “remote” monitor or the like positioned away from the ear system endoscope 8101, such as a monitor of a laptop 8991 (see FIG. 31) or a desktop computer, which could be located in the same room in which the ear system endoscope is being utilized to reach the cochlea. Accordingly, it can be seen that in some scenarios of use the surgeon or other healthcare professional or whoever is utilizing the ear system endoscope guides the endoscope through the ear system by looking at the endoscope / looking in the direction of the side of the human’s head / looking at the outer ear, while in some other embodiments, the guiding is executed while the user is looking at a computer screen and thus looking in a direction away from the human’s head / outer ear, etc.

[00177] Again referring back to figure 29, the ear system endoscope 8101 further includes a surgical tool port 8301. This port can be configured to receive a needle and/or a drill and/or a laser generator and/or output and/or or a micro tweezers or can just be a general port to which a therapeutic substance reservoir or a therapeutic substance supply line can be attached to deliver therapeutic substance to the inner ear. Furthermore, in an example, the port can receive a biopsy tool and/or blades and/or forceps and/or microneedles (microneedle array/assembly), catheters, etc. Moreover, by way of example only and not by way of limitation, in an exemplary embodiment, tools that are configured to take a sample of a fluid or a liquid within the body, such as perilymph within the cochlea and/or the fluid within the semicircular canals, example, can be extended through the aforementioned port(s).

[00178] An exemplary embodiment includes a steerable tip endoscope with a channel for vision and a channel for tools (e.g., a drill tip / grinder tip (note that any reference to a drill feature corresponds to a disclosure of an alternate embodiment of a grind feature and visa- versa), the tool bending in compliance with the tip angle. Thus, there could be 2, 3, 4 or more surgical tool ports 8301.

[00179] Also, as can be seen, there is an irrigation port 8401, which can be utilized to provide irrigation fluid, such as a saline liquid, to the working end of the ear system endoscope, which can be used to provide irrigation of the middle and/or inner ear during use of the tool. The tympanic membrane can also be irrigated utilizing the irrigation features of the ear system endoscope in some embodiments. [00180] As can be seen, the channel 8201 and the ports 8301 and 8401 are supported by a body 8501, which can be ergonomically designed so that a surgeon or other healthcare professional and easily grip and support the ear system endoscope with a thumb and one or more fingers of a hand, or the entire hand.

[00181] The working end of the ear system endoscope 8101 includes a termination 8601, which can be a tube made of metal, such as stainless steel (e.g., 316), or some other material. In an exemplary embodiment, the termination 8601 can correspond to those of at least the body portion (which may or may not include the sharp end) of a syringe termination approved for use in the United States as of December 31, 2021. This can be a low volume, medium volume, or high volume termination. In an exemplary embodiment, the termination is sized and dimensioned the termination can extend from the tympanic membrane 104 to the promontory (and into the promontory) and/or to the round window niche of the cochlea, when the base 8501 is inserted into the ear canal and/or is located at the beginning of the ear canal (as seen in FIG. 30).

[00182] It is noted that while embodiments will be described in terms of the “extensive” endoscope 8101 of FIG. 29 and FIG. 30, other embodiments can use other types of hand tools that have only some of the features of the endoscope 8101 described herein (and may not be an endoscope per se - any component detailed herein can be excluded from any embodiment or other embodiment). For example, FIG. 29A depicts a hand-tool 8101A that has only the surgical access port 8301. Here, a drill motor 2949 and a flexible drill shank 2959 is shown in use with the hand tool 8101A (this can be used with the endoscope 8101 as well). The flexibility of the elongate drill shank permits the drill motor to be positioned out of the line of sight of the ear canal so as to provide more visibility to the user than that which would otherwise be the case. A boring surface as detailed herein connected to the flexible drill shank and/or a bore tool as detailed herein is connected to the flexible drill shank, and the boring surface / tool is located in the termination 8601, and can be extend through / out of the termination at least in part as will be detailed below. The drill motor turns the shank which turns the boring surface. The forward / reverse movement of the boring surface(s) can be controlled by a mechanical device or electromechanical in the tool (a gear mechanism can push the shank forward or pull it backwards), or by simply moving the shank forward or backward.

[00183] FIG. 29B depicts an exemplary compact hand tool 8101B that is a dedicated drill / grinder (but note some of the features of tool 8101B can be used with the embodiment of FIGs. 29 and 29A - that is, tool 8101A can have the compact features of tool 8101A). Here, the hand tool includes a body 8519 (grip) that is of reduced size compared to body 8501 of the endoscope. The bore tool can be located in the termination 8601, and a compact drill motor can be located inside the body 8519 (the drill motor of tool 8101A and flexible shank can be used in a variation - an opening can be present in the back end through which the shank extends extending to the termination 8601). A thumb or finger activated plunger 8555 advances / retracts the bore tool. Button 8585 is used to initiate and/or control rotational speed of the bore tool, where button 8585 can be electrically connected to the drill motor. In an embodiment, the button 8585 is a multi-use button, that both advances the bore tool and controls the speed / activates the rotation (and deactivates the rotation).

[00184] In an embodiment, a wired or wireless hand operated or foot operated device can be used to control the tool (e.g., a foot pedal can be used to control / activate rotation). This can free the surgeon / healthcare professional to simply use one hand to steady / position the drill bit. Indeed, a voice activated / voice controlled system can be used to control the speed / activate the rotation.

[00185] Some embodiments of the hand tool 8101B have utilitarian value in that it is tiny enough and compact enough to be operated with one hand by a surgeon or other healthcare professional, and is tiny enough to permit visibility into the ear canal during the operation of boring and/or inserting the port into the excavation (the hand tools can in some embodiments be used to insert the port after the boring action. With respect to the dedicated drill / grinder of 180 IB, the boring surfaces can be withdrawn into the termination, and the port could be placed on the distal end of the termination and carried by the termination to the excavations. Alternatively, an adapter for the termination can be utilized. The boring surfaces can be withdrawn into the handle, and a new termination can be placed onto the handle, which new termination is sized and dimensioned support the port body. A termination can be placed over the existing termination, which new termination supports the port body. The user can utilize this new termination to transport the port to the excavation place the port into the excavation and otherwise secure the excavation to the bone.

[00186] As noted above, embodiments include methods that are executed without utilizing an endoscope, where at least method actions are executed that include boring through the barrier between the middle ear and the inner ear without an endoscope. In at least some exemplary scenarios, the actions of accessing the surface of the barrier between the middle ear in the inner ear and/or boring through the barrier in whole or part are executed with the aid of an endoscope. That is, a device that enables vision of the promontory beyond that which would otherwise be the case with normal eyesight. Conversely, at least some of the features detailed herein enable the access to the surface of the barrier and/or the boring through at least a portion of the barrier if not all of the barrier without utilizing an endoscope or an artificial vision device (a magnifying glass or a surgical microscope is not artificial vision, just as the utilization of eyeglasses is not artificial vision - a retinal prosthesis conversely, is something that provides artificial vision, as is the case with a CT scan or an X-ray). In some embodiments, the nature of the tools can permit this to be done blindly. That said, in some embodiments, and endoscope is first used to “stake out” the area within the middle ear of interest, and then the endoscope is removed and not used to position the boring tool, etc.

[00187] In view of the above, there is a method of executing the action of placing the boring tool on the promontory prior to the commencement of drilling and/or drilling / grinding through the promontory at least partially without utilizing artificial vision or otherwise without utilizing an endoscope. In an exemplary embodiment, at least 50, 55, 60, 65, 70, 76, 80, 85, 90, 95 or 100% or any value or range of values therebetween in 1% increments of the depth of the first and/or second excavations and/or the total passageway is bored without visually seeing the promontory and/or the working end of the boring tool utilizing artificial vision and/or an endoscope. It is also noted that any one or more of the above noted qualifications can also be applicable to utilization of the pilot tool detailed. Still, it is noted that in some exemplary embodiments, and endoscope or otherwise artificial vision can be utilized to inspect the bored area after the action of boring is completed.

[00188] Note also that in at least some exemplary embodiments, the action of positioning the port in the excavation for permanent placement and/or the action of positioning the port proximate the excavation prior to the action of positioning the port in the excavation is executed without utilizing artificial vision and/or an endoscope. In an exemplary embodiment, there is no intervening use of artificial vision between the end of the action of boring and the action of placing the port for permanent placement and/or positioning the port in the excavation. That said, in some embodiments, there is the utilization of artificial vision between the action of boring and the action of placement of the port and/or positioning the port. In an exemplary embodiment, the action of boring can be halted temporarily, and then an endoscope can be utilized to inspect the area, the endoscope is then removed, and then the action of boring can continue. The idea is that by enabling boring without having an artificial device needing to be present during the action of boring, there is more room for the boring tools and/or the procedure is less invasive than that which would otherwise be the case. The fact that the area of the middle ear can be repeatedly access with an endoscope when the boring tool is removed or otherwise not being utilized to bore through the tissue does not frustrate or otherwise impede the minimal invasive nature of the procedure.

[00189] No, embodiments include executing the entire procedure without an endoscope or otherwise without artificial vision. In an exemplary embodiment, the maximum diameter of the hand tool normal to the longitudinal axis and/or the maximum diameter of the grip body is less than and/or equal to 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8 or 7 mm or any vale or range of values therebetween in 0.1 mm increments. At least some of these provide for the aforementioned visibility into the ear canal.

[00190] FIG. 30A shows the use of the tool 8101B to bore the excavations. In an exemplary embodiment, as measured from the centerline of the excavation at the highest point on that line on the bone surface before boring, all of the tool more than 5 mm from the distal end and/or the body (grip) (this could be for the endoscope and/or the tool 8101A, etc.) falls within a cone having an angle A5 (the cone could be rotated about the longitudinal axis of the termination, and the angle from the axis to the cone surface would be half A5). A5 can be less than and/or equal to 25, 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5 or 4 degrees or any value or range of values therebetween in 0.1 degree increments.

[00191] Any disclosure of an endoscope corresponds to an alternate disclosure of an altemat embodiment of a more limited hand-tool and visa-versa. More specifically, as seen in figure 30 the ear system endoscope 8101 can be seen extending into the outer ear 102 / ear canal 102, with a component penetrating the tympanic membrane 104, which component extends all the way to the promontory. As seen, the embodiments of FIGs. 29A and 29B are artificial-vision-less devices.

[00192] In an embodiment, the hand tools of the embodiments of FIGs. 29A and 29B have not optical components associated therewith (lenses for example). In an embodiment, the tools have light sources / are configured to illuminate the target area.

[00193] FIG. 30 shows a laptop in signal communication with the endoscope 8101. As noted above, owing to the disclosure that features can be used with other embodiments providing that the art enables such unless otherwise stated, the laptop can be used with the hand tool of FIG. 29A or FIG. 29 B for example in an expanded version of those tools. [00194] FIG. 31A depicts an exemplary embodiment for accessing the inner ducts of the cochlea. (We focus on the endoscope, but note that the teachings can apply to the other hand tools. We focus on the endoscope for purposes of textual economy. Any disclosure of a feature of one and/or use of one corresponds to a disclosure of that feature and/or use with the other hand tools, etc.) This is a conceptual example of how the inner ducts of the cochlea can be accessed utilizing an exemplary ear system endoscope. Briefly, shown is a cross-section of the outer middle and inner ear, where the scala tympani 183 is shown below the scala vestibule 181. For frame of reference, also shown is the scala media 185 and the organ of Corti 187. In this exemplary embodiment, the termination 16601 of the endoscope (which can correspond to termination 8601 above) is utilized to puncture through the tympanic membrane 104 as shown. The termination 16601 is then extended downward towards the promontory (a steerable termination can be used in some embodiments). The termination 1660 of the ear system endoscope includes the boring tool 2120A, which is sized and dimensioned to extend thought the termination 16601. In an exemplary embodiment, the entire termination 1660 or at least the portions extending through the tympanic membrane to the distal end thereof is configured to be rotated at a speed that can enable the boring tool 2021 A to be used to perform a cochleostomy as shown in FIG. 31 A. In some embodiments, it is only the boring tool 2021A that is rotated. In an exemplary embodiment, the boring tool can be part of an assembly or structure that extends through the lumen of the termination 16601. That is, in an exemplary embodiment, as shown in FIG. 3 IB, the termination above can be utilized to pierce the tympanic membrane 104, and then the tip of the termination can be moved to the promontory, and in an exemplary embodiment, the sharp tip can be utilized to stabilize the termination, and then the boring tool (here, tool 2100 of FIG. 21 is shown, and 2100A can be used or 2800A can be used, etc.) can be extended through the lumen of the termination, and then upon reaching the tissue of the promontory of the cochlea, the tool can be turned so as to drill or grind into the promontory and thus reach the duct of the cochlea as shown in figure 33. That said, in an alternate embodiment, the termination 1660 is utilized to puncture the tympanic membrane and to drill / grind through the promontory to reach the duct of the cochlea.

[00195] Accordingly, in an exemplary embodiment, the ear system endoscope can have a drill motor associated therewith to turn the termination 1660 an/or the boring tool within the termination 1660. Accordingly, in an exemplary embodiment, the surgical port 8301 can receive a boring tool apparatus that extends from a drill motor of a surgical tool located outside the ear system endoscope, which boring tool apparatus extends through the conduit of the termination 1660 and wherein the systems are configured so that the boring tool can extend outside of and pass the end of the termination 1660 so that drilling can commence.

[00196] In view of the above, it can be seen that in an exemplary embodiment, there is the action of turning a boring tool having a component of the tool extending through the tympanic membrane. In an exemplary embodiment, the boring tool is rotated at more than or equal to 300, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2250, 2500, or 3000 RMP or more, or any value or range of values therebetween in 10 RPM increments and this can be done while the boring tool extends through the tympanic membrane.

[00197] Thus, in an exemplary embodiment, there is a device, comprising a surgical hand tool that includes an incisor, wherein the device is a minimally invasive inner ear access device configured to reach the inner ear through a passage through the tympanic membrane no greater than 10 mm in diameter to incise through tissue and deliver a therapeutic substance, and the incisor is at least one of a drill bit configured to drill through a promontory of a cochlea of a human, or a conduit configured to pierce a round window of the human with a fully intact round window niche.

[00198] The device can correspond to the ear system endoscope noted above. In an exemplary embodiment, the device is configured to reach the inner ear through a passage through the tympanic membrane, which passage is no greater in diameter than 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 mm, or any value or range of values therebetween in 0.05 mm increments to incise through tissue and deliver a therapeutic substance. In an exemplary embodiment, the incisor is at least one of a drill bit or a grinder configured to drill or grind through a promontory of a cochlea of a human. In an exemplary embodiment, the termination can be a 2, 3, 4, 5 or 6 mm in diameter termination, and can include one or two or three or more working channels, and thus there can be utilitarian value to be able to extend through an opening of a pertinent size, and this can be for both piercing the tympanic membrane (myringotomy) but also for introducing the tool to the middle ear using a so called tympanomeatal flap, where the entire tympanic membrane is lifted towards the ceiling of the ear canal for maximum access to the middle ear.

[00199] It is noted that at least some exemplary embodiments include utilization of the tools herein and/or variations thereof with a robotic system. In this regard, FIGs. 31C and 32 are views of an exemplary embodiment of a bone excavation system and/or port implantation system 400 (as noted above, the endoscope 8101 can be used to implant the inner ear port). It is noted that the embodiment depicted in FIG. 32 and 31C are presented for conceptual purposes only. Features are provided typically in the singular so as to demonstrate the concept associated therewith. However, it is noted that in some exemplary embodiments, some of these features are duplicated, triplicated, quadplicated, etc. so as to enable the teachings detailed herein and/or variations thereof. Briefly, it is noted that any teaching detailed herein can be combined with a robotic apparatus and/or a robotic system according to the teachings detailed herein and/or variations thereof. In this regard, any method action detailed herein corresponds to a disclosure of a method action executed by a robotic apparatus and/or utilizing a robot to execute that action and/or executing that method action is part of a method where other actions are executed by robot and/or a robotic system etc. Still further, it is noted that any apparatus detailed herein can be utilized in conjunction with a robotic apparatus and/or a robot and/or a system utilizing such. Accordingly, any disclosure herein of an apparatus corresponds to a disclosure of an apparatus that is part of a robotic apparatus and/or a robotic system etc. and/or a system that includes a robotic apparatus etc.

[00200] System 400 includes a robotic insertion apparatus having the ear endoscope 8101 including a releasable connection to mount 7512, which is supported by a support and movement system, comprising support arm 422 which is connected to joint 426 which in turn is connected to support arm 424. Support arm 424 is rigidly mounted to a wall, a floor, or some other relatively stationary surface. That said, in an alternative embodiment, support arm 424 is mounted to a frame that is attached to the head of the recipient or otherwise connected to the head of the recipient such that global movement of the head will result in no relative movement of the system 400 in general, and the endoscope in particular, relative to the tissue of the human, such as the cochlea, or tympanic membrane, or round window, or promontory, etc. Joint 426 permits arm 2510, and thus the endoscope, to be moved in one, two, three, four, five, or six degrees of freedom. It is noted again that FIG. 31C and FIG. 32 are but a conceptual FIGs. - there can be joints located along the length of various components, such as for example arm 4222 enable that to articulate in the one or more of the aforementioned degrees of freedom at those locations. In an exemplary embodiment, joint 426 includes actuators that move mount 7512, and thus the endoscope, in an automated manner, as will be described below. In an exemplary embodiment, the system is configured to be remotely controlled via communication with a remote control unit via communication lines of cable 430. In an exemplary embodiment, the system is configured to be automatically controlled via a control unit that is part of the system 400. Additional details of this will be described below.

[00201] The system 400 further includes by way of example only and not by way of limitation, sensor / sensing unit 432. That said, in some embodiments, sensor 432 is not part of system 400. In some embodiments, it is a separate system. Still further, in some embodiments, it is not utilized at all with system 400. While sensor 432 is depicted as being co-located simultaneously with the endoscope, etc., as detailed below, sensor 432 may be used relatively much prior to use of the endoscope. Sensing unit 432 is configured to scan the head of a recipient and obtain data indicative of spatial locations of internal organs (e.g., mastoid bone 221, middle ear cavity 423 and/or ossicles 106, etc.) In an exemplary embodiment, sensing unit 432 is a unit that is also configured to obtain data indicative of spatial locations of at least some components of the endoscope and/or other components of the robotic apparatus attached thereto. The obtained data may be communicated to remote control unit 440 via communication lines of cable 434. As may be seen, sensor 432 is mounted to a support and movement system 420 that may be similar to or the same as that used by the robotic apparatus supporting the endoscope.

[00202] In an exemplary embodiment, sensing unit 432 is an MRI system, an X-Ray system, an ultrasound system, a CAT scan system, or any other system which will permit the data indicative of the spatial locations to be determined as detailed herein and/or variations thereof. As will be described below, this data may be obtained prior to surgery and/or during surgery. It is noted that in some embodiments, at least some portions of the endoscope are configured to be better imaged or otherwise detected by sensing unit 432. In an exemplary embodiment, the tip of the endoscope includes radio-opaque contrast material. The stop of the endoscope can also include such radio-opaque contrast material. In an exemplary embodiment, at least some portions of endoscope in general, and the robotic system in particular, or at least the arm 7510, mount 7512, arm 422, etc., are made of nonferromagnetic material or other materials that are more compatible with an MRI system or another sensing unit utilized with the embodiment of FIG. 66 than ferromagnetic material or the like. As will be described in greater detail below, the data obtained by sensing unit 432 is used to construct a 3D or 4D model of the recipient's head and/or specific organs of the recipient's head (e.g., temporal bone) and/or portions of the robotic apparatus of which the endoscope is a part. That said, to be clear, in some embodiments, sensing unit 432 is not present, as seen in FIG. 32.

[00203] It is also noted that in some exemplary embodiments of system 400, there are actuators or the like that drive the endoscope into the ear structure. These actuators can be in signal communication with the control unit. In an exemplary embodiment, the control unit can control the actuators to push the into and/or out of the ear system as will be described in greater detail below. Concomitant with the robotic assembly supporting the endoscope, in an exemplary embodiment, the control unit is configured to automatically control these actuators.

[00204] FIG. 33 is a simplified block diagram of an exemplary embodiment of a remote control unit 440 for controlling the robotic apparatus supporting the endoscope and sensing unit 432 via communication lines 430 and 434, respectively. Again, it is noted that in some alternate embodiments, the remote control unit 440 is an entirely automated unit. That said, in some alternate embodiments, the remote control unit can be operated automatically as well as manually, which details will be described below.

[00205] Remote control unit 440 includes a display 442 that displays a virtual image of the tissue obtained from sensor 432 and/or component(s) of the endoscope and may superimpose a virtual image of the insertion apparatus onto the virtual image indicative of a current position of the tool relative to the ear anatomy. An operator (e.g., surgeon, certified healthcare provider, etc.) utilizes remote control unit 440 to control some or all aspects of the robotic apparatus and/or sensing unit 432. Exemplary control may include depth of insertion, angle of insertion, speed of advancement and/or retraction of the tool (endoscope for example), etc. (It is noted that any reference to advancement and/or retraction also corresponds to an alternate disclosure of lateral movement and/or rotation of the tool and/or a change in the angle on any one or more of the three planes relative to the tissue that is the target, etc.) Such control may be exercised via joystick 450 mounted on extension 452 which fixedly mounts joystick 450 to a control unit housing. Such control may be further exercised via joystick 460 which is not rigidly connected to housing of remote control unit 440. Instead, it is freely movable relative thereto and is in communication with the remote control unit via communication lines of cable 462. Joystick 462 may be part of a virtual system in which the remote control unit 440 extrapolates control commands based on how the joystick 462 is moved in space, or joystick may be a device that permits the operator more limited control over the cavity borer 410. Such control may include, for example an emergency stop upon release of trigger 464 and/or directing the robot to drive the endoscope further into the ear system, etc. by squeezing the trigger 464 (which, in some embodiments, may control a speed at which the endoscope is advanced by squeezing harder and/or more on the trigger). In the same vein, trigger 454 of joystick 450 may have similar and/or the same functionality.

[00206] Control of the robot assembly supporting the endoscope may also be exercised via knobs 440 which may be used to adjust an angle of the endoscope in the X, Y and Z axis, respectively. Other controls components may be included in remote control 440.

[00207] Figure 34 depicts an exemplary functional schematic of an exemplary system that includes a data collection unit 3960 that receives data from, for example, the sensors of the endoscope, in signal communication with a control unit 8310 which is in turn in signal communication with an actuator assembly, 7720, where the actuator assembly 7720 is a proxy for a component that positions the endoscope, or at least advances and/or retracts the endoscope. The data collection unit and the control unit can be one and the same in some embodiments.

[00208] It is also noted that in some embodiments, the there is no control unit. That is, the system can be a purely data collection system, which conveys information to the surgeon or other healthcare professional to instruct (e.g., the output of the control unit and/or the test unit can be instead an instruction as opposed to a control signal) or otherwise provide an indication of the phenomenon to the surgeon or other healthcare professional.

[00209] Also functionally depicted in FIG. 34 is the optional embodiment where an input device 8320 is included in the system (e.g., which could be on an embodiment where the actuator assembly 7720 is connected to the endoscope, but the input device 8320 is located remote from the endoscope, which could be part of a remote unit 440). In an exemplary embodiment, the input device 8320 could be the trigger 454 and/or 464 of the remote control unit 440. Again, in an exemplary embodiment, the input device 8320 can be utilized to enable advancement and/or withdrawal of the endoscope and the system 400 could control the advancement and/or withdrawal based on an automated protocol or some other flyby wire type system. In the embodiment of FIG. 34, the input device 8320 can be in signal communication directly to the endoscope, and/or in signal communication with the control unit 8310.

[00210] In an exemplary embodiment, control unit 8310 can correspond to the remote unit

440. That said, in an alternate embodiment, remote unit 440 can be a device that is in signal communication with control unit 8310. Indeed, in an exemplary embodiment, input device 8320 can correspond to remote control unit 440.

[00211] More particularly, control unit 8310 can be a signal processor or the like or a personal computer or the like or a mainframe computer or the like etc., that is configured to receive signals from the data collection unit 3960 and analyze those signals to evaluate an insertion status of the endoscope. More particularly, the control unit 8310 can be configured with software the like to analyze the signals from unit 3960 in real time and/or in near real time as the endoscope is being advanced by an actuator assembly of the robotic system. The control unit 8310 analyzes the input from test unit 3960 as the endoscope is advanced by the actuator assembly for example, and evaluates the input to determine if there exists an undesirable insertion status and/or evaluates the input to determine if the input indicates that a scenario could occur or otherwise there exists data in the input that indicates that a scenario is more likely to occur relative to other instances where the insertion status of the endoscope will become undesirable if the endoscope is continued to be advanced into the ear system, all other things remaining the same (e.g., insertion angle / trajectory, etc., which can be automatically changed as well via - more on this below). In an exemplary embodiment, upon such a determination, control unit 8310 could halt the advancement of the endoscope by stopping the actuator(s) of actuator assembly and/or could slow the actuator(s) so as to slow rate of advancement of the endoscope and/or could reverse the actuator(s) so as to reverse or otherwise retract the endoscope (either partially or fully). In at least some exemplary embodiments, control unit 8310 can be configured to override the input from input unit 8320 input by the surgeon or the user or the like of the systems herein.

[00212] In an exemplary embodiment, the outputs of unit 3960 corresponds to the outputs indicated herein. Alternatively, and/or in addition to this, input into control unit 8310 can flow from other sources. Any input relating to the measurement of voltage associated executing the teachings herein into control unit 8310 can be utilized in at least some exemplary embodiments.

[00213] In an exemplary embodiment, control unit 8310 can be configured to determine, based on the input from test unit 3960, whether the endoscope has come into contact with the tympanic membrane and/or the round window and/or the promontory, etc., and/or that one or more anomalous endoscope positions has occurred and/or whether there exists an increased likelihood that such will occur, and automatically control the actuator assembly of the insertion system accordingly. In an exemplary embodiment, control unit 8310 does not necessarily determine that such an insertion status exists or is more likely to exist, but instead is programmed or otherwise configured so as to control the actuator assembly 7720 according to a predetermined regime based on the input from the test unit 3960. That is, the control unit 8310 need not necessarily “understand” otherwise “know” the actual insertion status or the forecasted insertion status of the endoscope, but instead need only be able to control the actuator assembly 7720 based on the input.

[00214] In an exemplary embodiment, control unit 8310 can be configured to determine, based on the input from test unit 3960, the insertion depth of the endoscope and/or a forecasted insertion depth of the endoscope, and automatically control the actuator assembly 7720 accordingly. In an exemplary embodiment, control unit 8310 does not necessarily determine the insertion depth or forecasted insertion depth, but instead is programmed or otherwise configured so as to control the actuator assembly 7720 according to a predetermined regime based on the input from the test unit 3960. That is, the control unit 8310 need not necessarily “understand” otherwise “know” the actual insertion depth or the forecasted insertion depth of the endoscope, but instead need only be able to control the actuator assembly 7720 based on the input.

[00215] In an exemplary embodiment, control unit 8310 can be configured to determine, based on the input from test unit 3960, executing, for example, the methods / techniques disclosed herein, whether the endoscope has buckled or has become hung up or has adopted an unutilitarian trajectory and/or position and/or any other anomalous endoscope location as disclosed herein or otherwise may be the case and/or whether there exists an increased likelihood that such will occur, and automatically control the actuator assembly 7720 accordingly. In an exemplary embodiment, control unit 8310 does not necessarily determine that such, exists or is more likely to exist, but instead is programmed or otherwise configured so as to control the actuator assembly 7720 according to a predetermined regime based on the input from the test unit 3960. That is, the control unit 8310 need not necessarily “understand” otherwise “know” that the condition has occurred or will occur in the future, but instead need only be able to control the actuator assembly 7720 based on the input.

[00216] To be clear, while the embodiment detailed above is focused on controlling the actuator assembly 7720 based on data from the system so as to control the advancement and/or retraction of the endoscope based on the data disclosed herein and, in an alternate embodiment, the system 400 controls one or more other actuators of the robot apparatus of system 400. These one or more other actuators can be exclusive from the actuator assembly 7720, or can include the actuator assembly 7720. In this regard, FIG. 35 depicts an exemplary robot apparatus 8400, that includes the endoscope detailed above and/or variations thereof with respect to the integration of a system disclosed herein therewith mounted on arm 8424 utilizing bolts in a manner concomitant with that detailed above. In an exemplary embodiment, robot apparatus 8400 has the functionality or otherwise corresponds to that of the embodiment of FIG. 33. In this regard, any functionality associated or otherwise described with respect to the embodiment of FIG. 33 corresponds to that of the embodiment of FIG. 35, and vice versa. In this exemplary embodiment, the actuator apparatus 7720 is in signal communication with unit 3810 via electrical lead 84123. In this regard, signals to and/or from the actuator assembly 7720 can be transmitted to/from the antenna of unit 8310 (the “Y” shaped elements are antennas) and thus communicated via lead 84123. It is briefly noted that while the embodiment depicted in FIG. 35 utilizes radiofrequency communication, in alternate embodiments, the communications can be wired. In an exemplary embodiment both can be utilized.

[00217] The robot apparatus 8400 includes a recipient interface 8410 which entails an arch or halo like structure made out of metal or the like that extends about the recipient’s cranium or other parts of the body. The interface 8410 is bolted to the recipient’s head via bolts 8412. That said, in alternate embodiments, other regimes of attachment can be utilized, such as by way of example only and not by way of limitation, strapping the robot to the recipient’s head. In this regard, the body and interface 8410 can be a flexible strapping can be tightened about the recipient’s head.

[00218] Housing 8414 is located on top of the interface 8410, as can be seen. In an exemplary embodiment, housing 8414 includes a battery or the like or otherwise provides an interface to a commercial/utility power supply so as to power the robot apparatus. Still further, in an exemplary embodiment, housing 8414 can include hydraulic components/connectors to the extent that the actuators herein utilize hydraulics as opposed to and/or in addition to electrical motors. Mounted on housing 8414 is the first actuator 8420, to which arm 8422 is connected in an exemplary embodiment, actuator 8420 enables the components “downstream” (i.e., the arm connected to the actuator, and the other components to the endoscope) to articulate in one, two, three, four, five or six degrees of freedom. A second actuator 8420 is attached to the opposite end of the arm 8422, to which is attached a second arm 8422, to which is attached a third actuator 8420, to which is attached to the endoscope attachment structure 8424. Elements 8422 and 8424 can be metal beams, such as I beams or C beams or box beams, etc. actuators 8420 can be electrical actuators and/or hydraulic actuators.

[00219] As can be seen, each actuator 8420 is provided with an antenna, which antenna is in signal communication with the control unit 8310. In an exemplary embodiment, control unit 8310 can control the actuation of those actuators 8420 so as to position the endoscope 3900 (generically identified - reference numeral 8101 is also used) at the desired position relative to the recipient. That said, in an alternate embodiment, a single antenna can be utilized, such as one mounted on housing 8414, which in turn is connected to a decoding device that outputs a control signal, such as a driver signal based on the decoded RF signal, to the actuators 8420 (as opposed to each actuator having such a device), which control signals can be provided via a wired system / electrical leads extending from housing 8414 to the actuators. Note also that in some alternate embodiments, control unit 8310 is in wired communication with the actuators, either directly or indirectly, and/or is in wired communication with the decoding device located in the housing 8414. Any arrangement that can enable control of the robot apparatus in general, and the actuators thereof in particular, via control unit 8310 can be utilized in at least some exemplary embodiments.

[00220] Note also that while the embodiment depicted in FIG. 35 is such that the actuators 8420 must actuate so as to extend the endoscope into the body, in an alternate embodiment, as noted above, the endoscope can be mounted on a rail system or the like, wherein a cylindrical actuator or the like pushes the endoscope in a linear manner into the head and withdrawals the endoscope in the linear manner from the head. In an exemplary embodiment, this actuator apparatus can enable one degree of freedom movements of the endoscope, while in other embodiments, this actuator apparatus can enable two or three or four or five or six degrees of freedom. Indeed, in an exemplary embodiment, this actuator apparatus can enable movement only in a linear direction, but can enable rotation of the endoscope about the longitudinal axis thereof. Any arrangement of actuator assemblies that will enable the endoscope to be positioned relative to the ear system via robotic positioning thereof can be utilized in at least some exemplary embodiments.

[00221] Any control unit and/or test unit or the like disclosed herein can be a personal computer programs was to execute one or more or all of the functionalities associated there with are the other functionalities disclosed herein. In an exemplary embodiment, any control unit and/or test unit or the like can be a dedicated circuit assembly configured so as to execute one or more or all of the functionalities associated there with or the other functionalities disclosed therein. In an exemplary embodiment, and the control unit and/or test unit or the like disclosed herein can be a processor or the like or otherwise can be a programmed processor.

[00222] FIG. 36 depicts another exemplary embodiment, as seen. FIG. 36 presents such an exemplary embodiment, with the links between the antennas removed for clarity. Testing system 4044 detailed shown in signal communication with control unit 8310. In this exemplary embodiment, system 4044 corresponds to that detailed above vis-a-vis determining anomalous endoscope location with the exception that it is entirely divorced from the endoscope, save for the communication between system 4044 and the control unit 8310, to the extent such is relevant for the purposes of discussion, where control unit 8310 is in signal communication with one or more of the assemblies of the robot apparatus, such as the actuator assembly 7720. Here, during insertion, and/or prior to insertion and/or after insertion, the system 4044 monitors or otherwise measures phenomenon detailed herein and communicates those measurements and/or the analysis thereof to control unit 8310, which analyzes those signals and develops a control regime for endoscope insertion and/or endoscope positioning based on those signals. Note also that in some exemplary embodiments, the system 4044 can have multiple measurement sensors, some of which are part of the robot apparatus, and some of which are separate from the robot apparatus, all of which are part of system 4044. Alternatively, these various components of the system 4044 can communicate with test unit 3960. Such can have utilitarian value with respect to a scenario where measurements are first taken prior to placing the endoscope near the pertinent tissues and after inserting the endoscope into the ear system, where it is undesirable to have the endoscope proximate certain tissue. Any device, system, and/or method that will enable controlled movement of the endoscope relative to the ear system and/or cochlea based on phenomenon associated with the recipient can be utilized in at least some exemplary embodiments.

[00223] Again, the test unit and the system 4044 can be one and the same in some embodiments, and in some embodiments, functionality can be bifurcated between the two as separate units. Indeed, element 4044 in FIG. 36 can be a proxy for the control unit and/or the test units detailed above.

[00224] It is briefly noted that any reference to an endoscope and/or a drill bit and/or a hand tool herein corresponds to a disclosure of an alternate embodiment that includes that feature in a more generic tool and/or in another of the tools disclosed herein, and visa-versa. [00225] As noted above, embodiments can include the utilization of a self-healing septum. The septum is configured to permit repeated puncturing and subsequent healing by a termination of a syringe. A termination can be inserted through the septum so that a therapeutic substance can be injected into the area of the body to the right of the septum, and thus be in fluid communication with the cavity 199 of the middle ear.

[00226] In an embodiment, the port establishes a hermetic seal between the port and the middle ear cavity. It is noted that embodiments can make ample use of hermetic enclosures, such as those that can be metal and/or ceramic (e.g., ceramic/metal braze feedthroughs). Thus, any disclosure herein of any component corresponds to a disclosure of an alternate embodiment or an additional embodiment where such components are hermetically isolated or otherwise hermetically sealed from the other components and/or the ambient environment. That said, in some embodiments, hermetic sealing is not necessarily needed or otherwise always utilized.

[00227] In an exemplary embodiment, the cap / plug can be made out of biocompatible silicone.

[00228] In any event, in at least some exemplary embodiments, when the cap / plug is located in the body of the port, the only way that fluid can transfer from the cavity 106 to the cavity 199 and/or vice versa is through the passage in the port.

[00229] In an exemplary embodiment, as differentiated from, for example, the arrangement of figure 5 and/or 4, which, as noted above, are not part of the invention, but provide teachings that can be utilized to implement some aspects of the invention, all of the componentry associated with the inner ear device is located within a volume of 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 90, 100, 125, 150, 175, 200 or 300 or 400 or 600 or 800 or 1000 mm ³ or any value or range of values therebetween in 1 mm ³ increments. In an exemplary embodiment, the aforementioned volumes are established by a cube volume, or a volume established by rectangular sides (again, it is within - the device need not be a cube - this can be analogous to shipping volume specifications for a box or container) where the largest straight dimension of the side is 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 15 or 20 mm or any value or range values therebetween in 0.1 mm increments. In an exemplary embodiment, the entire device of the inner ear port is located within 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 15, or 20 mm, or any value or range of values therebetween in 0.1 mm increments of a natural inner ear cavity.

[00230] In view of the above, it can be seen that in an exemplary embodiment there is a device, such as an implantable device, including a tissue interface portion, such as body 1110 configured for securement to tissue of and/or proximate an inner ear of a human and provide a structurally stable passage, which can be a long term passage, from outside the inner ear to inside the inner ear. The device also includes a component (e.g., the cap or plug, or a passive or active device (e.g., a sensor, or a drug / therapeutic delivery device, etc.) releasably attached to the tissue interface portion and/or a portion of the device supported by the tissue interface portion (e.g., there could be an intermediate device between the two). This component is a passive component or an active component (or both). By way of example only and not by way of limitation, a drug-eluting capsule can be located in the port body. In an embodiment, the device is configured to enable the component to be removed from the tissue interface portion when the tissue interface portion is removably permanently fixed to the barrier establishing the inner ear of a human, and the component at least partially seals the passage and provides one or more passive features. The, the component can completely seal the passage. In other embodiments, the device is configured to enable the component to be removed from the tissue interface portion when the tissue interface portion is removably permanently fixed to the barrier establishing the inner ear of a human, and the device also includes a removable seal apparatus configured to unsealably seal the passage.

[00231] The port prosthesis can establish and artificial round window. The inner ear prosthesis can be one that replicates the performance of the round window or oval window can be located at other locations, such as at locations in a cochleostomy through the bone that establishes the boundary between the middle ear in the inner ear further up the scala.

[00232] The port can receive a reservoir that contains a therapeutic substance, where the therapeutic substance is configured to defuse through an outer wall thereof and through the passage into the cochlea.

[00233] In an exemplary embodiment, the port device is completely unrelated to any function in the auditory system.

[00234] Embodiments can enable repeated sealingly access from the middle ear to the inner ear through a sealable passage in the prostheses / port device. This can be achieved, by way of example, by the cap / plug that can be screwed onto the body 1110 as detailed above. Alternatively, and/or in addition to this, in an exemplary embodiment, this can be enabled by, for example, a self-healing septum. In this regard, in an exemplary embodiment, the passive component at least is indirectly releasably attached to the tissue interface portion and/or a portion of the device supported by the tissue interface portion can include a self-healing septum.

[00235] Note that a cap or plug can be used over the septum, where the cap / plug is removed to access the septum.

[00236] Embodiments can include a system that includes an inner ear barrier tissue interface apparatus (e.g., element 1110) through which a passage extends, wherein the inner ear barrier tissue interface apparatus is configured to permanently fix to an opening in a barrier between a middle ear and an inner ear of a human such that the passage extends from the middle ear to the inner ear. In this exemplary embodiment, the system further includes a first functional component at least partially located in the passage. In this exemplary embodiment, at least one of (i) the first functional component is a passive or active first functional component detachably attached directly or indirectly to the tissue interface apparatus and removal of the first component provides physical access from the middle ear into the inner ear through the passage, wherein the first functional component at least partially seals the passage in addition to providing a passive or active feature; (ii) the tissue interface apparatus includes a second passage that is unsealably sealed, the second passage providing physical access from the middle ear into the inner ear through the second passage bypassing the first functional component or the first functional component is a first functional component detachably attached directly or indirectly to the tissue interface apparatus and removal of the first component provides physical access from the middle ear into the inner ear through the passage, wherein the system further includes a removable seal apparatus (a plug and/or a cap, for example), configured to unsealably seal the passage, the removable seal apparatus being separate from the first functional component; or (iii) the first functional component has a passage that is unsealably sealed, the passage of the first component providing physical access from a middle ear facing side to an inner ear facing side when unsealed with the first functional component in the passage of the tissue interface apparatus.

[00237] A sensor could be located in the passage of the port.

[00238] Active components could also be located in the port, which active component interacts with the perilymph of the inner ear for example. In some embodiments, the inner ear port apparatus includes insulated electrically conductive material configured to conduct an electrical signal. In some embodiments, the device is configured to actively control itself and/or to be actively controlled remotely to deliver therapeutic substance contained the port to an inner ear, and a therapeutic substance container of the port is configured to be located entirely within a middle ear cavity and/or the inner ear of a human. In an embodiment, there is a system, comprising an inner ear barrier tissue interface apparatus through which a passage extends, wherein the inner ear barrier tissue interface apparatus is configured to permanently fix to an opening in a barrier between a middle ear and an inner ear of a human, and an active first component, wherein the system is configured to enable resealable physical access from the middle ear into the inner ear through the passage, the active first component is detachably attached directly or indirectly to the inner ear barrier tissue interface apparatus, and the system is configured to enable the active first component to be readily removed from the inner ear barrier tissue interface when the inner ear barrier tissue interface apparatus is permanently fixed to the barrier between the middle ear and the inner ear of the human.

[00239] There can be an active component that is part of a port assembly that includes a module that has an active component, such as a cochlear implant electrode array assembly, or a drug delivery device, or an active sensor. The active first component or a device implanted in the human and in signal communication with the active first component (for example, where the port body 1110 includes a receiver and/or transmitter and/or transceiver in total or at least one or more portions of those components) includes a receiver, transmitter and/or a transceiver apparatus and the associated antenna componentry. In an exemplary embodiment, such as this exemplary embodiment, the active component includes a wireless receiver. An active component can be located in an In-The-Ear (ITE) device that can be in signal communication via an inductance link established by coils of the ITE device that are configured to communicate with the implanted coils of an implanted assembly that is implanted beneath the surface of the ear canal. The assembly includes an electrical lead that extends from the assembly located proximate the ear canal along the ear canal underneath the skin, and then extending across the middle ear cavity 106 to the active component of the port device. The ITE device is configured to control operation of the active component via the transcutaneous induction communication link between the transmitter and the receiver. In this regard, the active first component need not be a component that is configured to autonomously operate, although in other embodiments, this can also be the case. And note that this arrangement can also be utilized to instead enable the autonomous operation of the active component.

[00240] In an embodiment, the implanted device includes a more conventional antenna (not an inductance coil antenna in this embodiment, and in other embodiments, it can be an inductance coil antenna). This communicates with an antenna that is part of an ITE device. This communication can be Bluetooth or can be a higher frequency RF communication regime (higher than that of the inductance coil embodiments, which embodiments can be about 5MHz for example). Still, it is noted that the ITE device can include the inductance coil antenna as shown. This can enable the ability to communicate with both of the communication regimes noted herein.

[00241] In some embodiments, there is a device, comprising a tissue interface portion configured for securement to tissue of and/or proximate an inner ear of a human and provide a long term passage from outside the inner ear to inside the inner ear, and a therapeutic substance delivery device at least indirectly releasably attached to the tissue interface portion and/or a portion of the device supported by the tissue interface portion, wherein the device is configured to actively control itself and/or to be actively controlled remotely to deliver the therapeutic substance to an inner ear, and the therapeutic substance is configured to be located entirely within a middle ear cavity and/or the inner ear of a human.

[00242] In some methods of using the port, there is an action of enabling a component located in / supported by the port body (directly or indirectly) to execute a function in an autonomous active manner. This can be the delivery of therapeutic substance in an active manner, this could be the active sensing (e.g., perilymph chemistry), this could be the active establishment of a hearing percept via electrical stimulation resulting from a cochlear implant. The autonomous feature is that, once enabled, the device operates on its own in a manner concomitant with the autonomous teachings detailed above.

[00243] In an embodiment, the port openably closes a passageway between the inner ear and the middle ear, wherein the port has been implanted in the human for at least one month, removing a first component that has been implanted in the human, and coupled to the port, for at least 10 days, removably attaching a second component to the port after removing the first component, and enabling the second component to execute a function in an autonomous active manner. [00244] In some embodiments, the device is configured, when the plug or cap, etc., is removed from the device, so that the passageway is open when the component is releasably attached to the tissue interface portion and/or a portion of the device supported by the tissue interface portion. In some embodiments, the component is configured, when the plug / cap etc., is removed from the device to unsealably seal a local portion of the passageway when the component is releasably attached to the tissue interface portion and/or a portion of the device supported by the tissue interface portion. There can also be a passageway thought he component, which passageway can also be sealed by another plug or cap (there can be two plugs or caps, or can be only that sealing the passage of the component).

[00245] In an exemplary embodiment, plugs / bodies located in the tissue interfacing body can be made of a silicone or a polymer and/or a low durometer polymer. The septum can be configured for utilization with a non-coring needle / termination, and thus the teachings detailed herein can be utilized with such and include methods of utilizing such.

[00246] The inner ear port device can be configured to be secured into the labyrinth (cochlea, semi-circular canals, and/or otolith, depending on the embodiment), and can be utilized to provide direct access to inner ear fluid and/or tissue (perilymph, endolymph, etc.). In some exemplary embodiments, the enablement of the direct access to inner ear fluid can enable measurements of biomarkers in inner ear fluid, can enable delivery of drugs and/or other substances, including implants into inner ear fluid, and/or can enable sampling of inner ear fluid to allow for analysis inside the port and/or outside the body. One implementation of the inner ear port, as seen above, includes two units, where one is configured to be secured into and/or to bone or tissue and the other is configured to be attached to and/or inserted into the unit secured into bone or tissue.

[00247] It is further noted that the phrase “releasably attached” refers to a structure that enables the container to be readily detached in a normal and expected manner so as to permit resupplied. This is as distinguished from, for example, the mere ability to disassemble various components. That is, even if, for example, the container could be saved for example, cut from the tissue interface, such would not correspond to releasably attached.

[00248] Consistent with the teachings detailed above, in some exemplary embodiments, the tissue interface is located in bone establishing a barrier between the middle ear and the inner ear. In some exemplary embodiments, the tissue interface has been implanted in the bone for at least and/or equal to 3, 4, 5, 6, 7, 8, 9, 10, 11 months, or 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 or more years, or any value or range of values therebetween in one week increments.

[00249] In an exemplary embodiment, the passive component was implanted for or for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 or more, or any value or range of values in 0.1 increments days or weeks or months or years less than the tissue interfacing portion.

[00250] Some embodiments include the action of utilizing the inner ear port device as a cochleostomy without a sheath for insertion of a cochlear implant electrode array.

[00251] Some embodiments include an inner ear device that is a device that is dedicated to the functionality of establishing long-term biocompatible ready access to the inner ear from the middle ear. This as distinguished from, for example, a cochlear implant, where a portion of the implant extends from the middle ear into the inner ear. In an exemplary embodiment, the inner ear device has no componentry configured to evoke a sensory response of the human. In an exemplary embodiment, the inner ear device has no componentry configured to electrically and/or mechanically stimulate tissue to evoke a sensory response of the human. This is distinguished from, for example, the potential that one or more of the electrical devices detailed herein may apply current somehow to tissue of the recipient. Further, in some embodiments, even if there is stimulation to tissue, providing that does not evoke a sensory response of the human, such would still be within the scope of some embodiments. To be clear, in some embodiments, there is no arrangements of the inner ear device that is stimulative. In some embodiments, the purpose of the implant is to provide the long-term ability to access the inner ear from the middle ear.

[00252] Thus, in view of the above, it can be seen that in some embodiments, there is a device, comprising a tissue interface portion configured for securement to tissue of and/or proximate an inner ear of a human and provide a long term passage from outside the inner ear to inside the inner ear, and a therapeutic substance at least indirectly releasably attached to the tissue interface portion and/or a portion of the device supported by the tissue interface portion, wherein the device is configured to passively provide a therapeutic substance to an inner ear, and the therapeutic substance is configured to be located entirely within a middle ear cavity and/or the inner ear of a human.

[00253] In an exemplary embodiment, there are method actions that include, and there are devices and/or systems that enable, repeated access to the inner ear, such as to the cochlea, or the vestibule ducts, more than 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 40, 45, 50, 55, 60, 70, 80, 90, or 100 times or more, or any value or range of values therebetween in one increment in a time period spanning 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, or 36 months, or years, or any value or range of values therebetween in one month increments. Embodiments include devices and systems that enable, and methods of, accessing perilymph and/or other fluids, directly (as opposed to indirectly) of the inner ear repeatedly in a safe manner, along a path or route that corresponds to that which was previously the case to do so, in some embodiments, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 40, 45, 50, 55, 60, 70, 80, 90, or 100 times or more, or any value or range of values therebetween in one increments. Embodiments can enable the concept of treatment of the inner ear where only one portion of the inner ear and/or the barrier that establishes a barrier between the inner ear and the middle ear, is put “at risk” at one time. Accordingly, if a problem arises, and the implant and/or a device cannot be utilized, a workaround can be implemented at another, “virgin” location.

[00254] In an exemplary embodiment, the teachings detailed herein are utilized as part of a method to, and/or the teachings detailed herein are utilized with a device and/or system configured to, treat Meniere’s Disease and/or another chronic disease and/or to treat age- related hearing loss. In an exemplary embodiment, the teachings detailed herein are utilized as part of a method to, and/or the teachings herein are utilized with a device and/or system configured to, treat tinnitus, such as by way of example, suppress the perception of tinnitus. In an exemplary embodiment, the teachings detailed herein are utilized as part of a method to, and/or the teachings herein are utilized with a device and/or system configured to, treat an autoimmune scenario with respect to the inner ear, or some other inner ear disease, or a disease that affects otherwise has a deleterious effect on the function of the inner ear. By way of example only and not by way of limitation, embodiments can include enabling the provision of a steroid being supplied to the inner ear all the time.

[00255] By way of example only and not by way of limitation, exemplary method actions include providing a therapeutic substance at an efficacious level and/or at a level that can be measured to be an amount that is statistically efficacious, for at least 60, 65, 70, 75, 80, 85, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, or 100%, or any value or range of values therebetween in 1% increments of a collective number of hour or day increments over any one or more of the aforementioned temporal periods herein (e.g. the efficacious level exists in at least 21 hours out of each day in a 3 month period). And exemplary devices and/or systems include devices and/or systems that can enable such. In this regard, the aforementioned method can be executed utilizing one or more of the devices detailed herein and/or variations thereof.

[00256] By way of example only and not by way of limitation, in an exemplary embodiment, the teachings detailed herein are utilized as part of a method to treat balance and/or vertigo. In an exemplary embodiment, the teachings detailed herein are executed to enable a human who previously was not able to drive a vehicle or otherwise operate machinery in a safe manner, including in a scenario where a licensed organization or a supervisory organization (e.g., a Department of Motor Vehicles) previously deemed the person unable to do so. Accordingly, exemplary methods include receiving permission from such organizations to again continue executing one or more of these actions.

[00257] In an exemplary embodiment, the methods herein include attaching and unattaching various apparatuses to/from the port at least Z times over a period of Z years (the Zs need not be equal), where Z can be 1 to 250 or any value or range of values in 1 increment (Z can be more).

[00258] In some embodiments, there is a drug elution portion of the port that keeps the port open at the inner ear side. For example, a passive component 3501 can include a ring 3551 of long lasting slow release steroid, NSAID or antifibrotic that prevents fibrosis blocking the port.

[00259] An exemplary method includes utilizing a body that comprises a biosuitable material to establish a permanent tissue interfacing implant that provides a passageway from the middle ear into the inner ear. In an exemplary embodiment, the aforementioned biosuitable material causes a mammalian inflammatory response, and this can be utilitarian with respect to providing a seal between the tissue (wall of the cochlea through which the body passes) and the body. In any event, at least some exemplary embodiments of the tissue interfacing body integrate in a utilitarian manner with the cochlear bony wall. A second component or second module is placed or otherwise is located in the passageway so as to fluidically seal the cochlea with respect to the passage that has been created, in which the implant is located.

[00260] It is noted that at least some exemplary embodiments include providing a “universal” tissue interface body that establishes a passage between the middle ear and inner ear. By way of example only and not by way of limitation, this can correspond to the body 1110 detailed above by itself. The body can include a threaded passage therethrough, into which the threaded passage can initially be a threaded plug or cap that will seal the passage and prevent fluid leakage from the inner ear to the middle ear. This plug or cap can be considered a second module, and can be replaced with, in the future, another module that has one or more of the features and/or structural components detailed herein, or any other functional or structural component that can have utilitarian value. This can enable the functionalities to be changed in accordance with temporally changing needs of a recipient. Alternatively, and/or in addition to this, embodiments include a kit arrangement where, for example, the kit includes a tissue interface component, such as body 1110, and then a number of different second modules that have various functionalities. In an exemplary embodiment, this can enable a surgeon or otherwise a healthcare professional to basically “build” an implant according to the needs at the time of assessment.

[00261] In an exemplary embodiment, therapeutic substance include but are not limited to, any of those detailed above, and can include peptides, biologies, cells, drugs, neurotrophics, etc. Any substance that can have therapeutic features if introduced to the cochlea can be utilized in some embodiments.

[00262] It is noted that any disclosure of a device and/or system herein corresponds to a disclosure of a method of utilizing such device and/or system. It is further noted that any disclosure of a device and/or system herein corresponds to a disclosure of a method of manufacturing such device and/or system. It is further noted that any disclosure of a method action detailed herein corresponds to a disclosure of a device and/or system for executing that method action / a device and/or system having such functionality corresponding to the method action. It is also noted that any disclosure of a functionality of a device herein corresponds to a method including a method action corresponding to such functionality. Also, any disclosure of any manufacturing methods detailed herein corresponds to a disclosure of a device and/or system resulting from such manufacturing methods and/or a disclosure of a method of utilizing the resulting device and/or system.

[00263] Embodiments include embodiments where any or more of the teachings detailed herein can be combined with any one or more of the other teachings detailed herein unless otherwise noted providing that the art enables such. Embodiments also include embodiments where any one or more of the teachings detailed herein is specifically excluded from combination with any one or more of the other teachings detailed herein almost otherwise noted providing that the art enables such [00264] Unless otherwise specified or otherwise not enabled by the art, any one or more teachings detailed herein with respect to one embodiment can be combined with one or more teachings of any other teaching detailed herein with respect to other embodiments, and this includes the duplication or repetition of any given teaching of one component with any like component. It is also noted that embodiments can include devices systems and/or methods that specifically exclude one or more of the disclosures presented herein (i.e., it is not present).

[00265] While various embodiments of the present invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. It will be apparent to persons skilled in the relevant art that various changes in form and detail can be made therein without departing from the scope of the invention.