Prosthesis management of physical physiology

Abstract

An apparatus, such as an implantable medical device, includes an implantable device configured to cause trauma in an inner ear and / or middle ear recipient. In an exemplary embodiment, the implantable device is a cochlear implant. In an exemplary embodiment, an implantable device is configured to deliver a therapeutic substance to a body tissue of a recipient.

Description

[0001] This application is a divisional application with application number 201980020568.0 and invention name “Physiological Prosthesis Management”, which was filed on March 19, 2019, entered the Chinese national phase on September 18, 2020, and has the international application date of March 19, 2019.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to U.S. Provisional Application No. 62 / 645,455, filed on March 20, 2018, entitled “PROSTHESIS MANAGEMENT OF BODY PHYSIOLOGY,” naming Daniel SMYTH of Mechelen, Belgium as inventor, the entire contents of which are incorporated herein by reference in their entirety. Background Art

[0004] Hearing loss, which can arise from a variety of different causes, is generally classified into two types: conductive and sensorineural. Sensorineural hearing loss is caused by the absence or destruction of the hair cells in the cochlea that convert sound signals into nerve impulses. Various hearing prostheses are commercially available to provide individuals with sensorineural hearing loss with the ability to perceive sound. One example of a hearing prosthesis is a cochlear implant.

[0005] Conductive hearing loss occurs when the normal mechanical pathway that provides sound to the hair cells in the cochlea is blocked, for example due to damage to the chain of ossicles or the ear canal. Individuals with conductive hearing loss may retain some form of residual hearing because the hair cells in the cochlea may not be damaged.

[0006] Individuals with hearing loss typically receive acoustic hearing aids. Conventional hearing aids rely on the principle of air conduction to transmit acoustic signals to the cochlea. Specifically, hearing aids typically use an arrangement placed in the recipient's ear canal or on the outer ear to amplify the sound received by the recipient's outer ear. This amplified sound reaches the cochlea, causing movement of the perilymph and stimulation of the auditory nerve. Cases of conductive hearing loss are typically treated with bone conduction hearing aids. In contrast to conventional hearing aids, these devices use a mechanical actuator that couples to the skull to deliver the amplified sound.

[0007] In contrast to hearing aids, which rely primarily on the principle of air conduction, certain types of hearing prostheses, often referred to as cochlear implants, convert received sound into electrical stimulation. The electrical stimulation is applied to the cochlea, which results in the perception of the received sound.

[0008] Many devices, such as medical devices that interface with a recipient, have structural and / or functional features where there is utility in tailoring such features to an individual recipient. The process of customizing or tailoring or otherwise adjusting a device that interfaces with or is otherwise used by a recipient to the specific needs, requirements, or characteristics of the recipient is generally referred to as fitting. One type of medical device that has utility in such an individual recipient is the cochlear implant described above. That is, there are other types of medical devices that have utility in tailoring to a recipient, such as other types of hearing prostheses. Summary of the Invention

[0009] According to an exemplary embodiment, there is an implantable device configured to cause trauma in the inner ear and / or middle ear of a recipient. In some embodiments, the trauma is reversible, while in other embodiments, it is irreversible.

[0010] According to another exemplary embodiment, there is a method comprising: monitoring a physical phenomenon inside a cochlea of ​​a recipient; and managing a blood-labyrinth barrier of the recipient based on the monitored physical phenomenon.

[0011] According to another exemplary embodiment, there is a method that includes administering a therapeutic substance to a human being and causing trauma to the human being and / or inducing a foreign body reaction in or near an anatomical structure of the human being, thereby adjusting the concentration / amount of the therapeutic substance in the anatomical structure relative to a situation in the absence of the trauma and / or foreign body reaction.

[0012] According to another exemplary embodiment, a system is provided that includes an implantable blood labyrinth barrier management component configured to influence the blood labyrinth barrier to control an amount of a substance in an anatomical structure beyond an amount that would have occurred in the absence of the influence. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The following describes embodiments with reference to the accompanying drawings, in which:

[0014] Figure 1A is a perspective view of an exemplary hearing prosthesis in which at least some of the teachings detailed herein may be applied;

[0015] Figure 1B depicts a side view of a cochlear implant 100 external to a recipient;

[0016] Figure 2 Depicts a side view of a cochlear implant electrode array in a curled configuration;

[0017] Figure 3A depicts an exemplary cochlear implant electrode array according to an exemplary embodiment;

[0018] Figure 3B depicts an exemplary cochlear implant electrode array inserted into the cochlea;

[0019] Figures 4A-4C Depicts Figure 3A Some exemplary features of a portion of a cochlear implant electrode array;

[0020] Figure 5 Describes the use of Figure 3A An exemplary embodiment of a cochlear implant electrode array;

[0021] Figure 6 and Figure 7 Alternative exemplary embodiments of implantable components are presented that are configured to perform at least some of the method actions detailed herein;

[0022] Figure 8 and Figure 9 Alternative exemplary embodiments of implantable components are presented that are configured to perform at least some of the method actions detailed herein;

[0023] Figure 10-13 An exemplary algorithm for an exemplary method according to some exemplary embodiments is presented;

[0024] Figure 14 An exemplary system according to an exemplary embodiment is presented; and

[0025] Figure 15 Presented Figure 3A An alternative exemplary embodiment of the exemplary embodiment of FIG. DETAILED DESCRIPTION

[0026] Figure 1Ais a perspective view of a cochlear implant, referred to as cochlear implant 100, implanted in a recipient, to which some embodiments and / or variations thereof described herein may be applied. Cochlear implant 100 is part of a system 10, which, in some embodiments, may include external components, as described in detail below. Furthermore, it should be noted that the teachings described herein may also be applied to other types of hearing prostheses, such as, by way of example and not limitation, bone conduction devices (transcutaneous, active transcutaneous, and / or passive transcutaneous), direct acoustic cochlear stimulators, middle ear implants, and conventional hearing aids. Indeed, it should be noted that the teachings described herein may also be applied to so-called multimodal devices. In exemplary embodiments, these multimodal devices apply both electrical and acoustic stimulation to the recipient. In exemplary embodiments, these multimodal devices induce auditory perception via both electrical and bone conduction hearing. Therefore, unless otherwise indicated, or unless its disclosure is incompatible with a given device based on the current state of the art, any disclosure herein regarding one of these types of hearing prostheses corresponds to the disclosure of another of these types of hearing prostheses, or any medical device for that matter. Thus, in at least some embodiments, the teachings detailed herein may be applied to partially implantable and / or fully implantable medical devices that provide a wide range of therapeutic benefits to a recipient, patient, or other user, including hearing implants with implantable microphones, auditory brain stimulators, pacemakers, visual prostheses (e.g., bionic eyes), sensors, drug delivery systems, defibrillators, functional electrical stimulation devices, and the like.

[0027] In view of the foregoing, it will be appreciated that at least some of the embodiments and / or variations thereof described herein are directed to body-worn sensory supplemental medical devices (e.g., Figure 1A The present invention relates to a hearing prosthesis that supplements the sense of hearing even in the absence of natural hearing ability, for example due to a prior deterioration of natural hearing ability or due to any lack of natural hearing ability (e.g., since birth). It should be noted that at least some exemplary embodiments of some sensory supplementation medical devices are directed to devices such as conventional hearing aids that supplement the sense of hearing while maintaining some natural hearing ability, as well as visual prostheses (which are applicable to recipients with some natural visual ability as well as those without natural visual ability). Therefore, the teachings detailed herein are applicable to any type of sensory supplementation medical device that the teachings detailed herein enable use therein in a practical manner. In this regard, the phrase "sensory supplementation medical device" refers to any device that is used to provide a sensation to a recipient, regardless of whether the applicable natural sensation is only partially impaired or completely impaired or even not present at all.

[0028] The recipient has an outer ear 101, a middle ear 105, and an inner ear 107. Components of the outer ear 101, middle ear 105, and inner ear 107 are described below, followed by a description of the cochlear implant 100.

[0029] In a fully functioning ear, the outer ear 101 includes the pinna 110 and the ear canal 102. The pinna 110 collects sound pressure, or sound waves 103, and conducts them into and through the ear canal 102. Disposed across the distal end of the ear canal 102 is the eardrum 104, which vibrates in response to the sound waves 103. This vibration is coupled to the oval window or window 112 via three bones of the middle ear 105 (collectively referred to as the ossicles 106 and including the malleus 108, the incus 109, and the stapes 111). The bones 108, 109, and 111 of the middle ear 105 act to filter and amplify the sound waves 103, causing the oval window 112 to produce sound or vibrate in response to the vibrations of the eardrum 104. This vibration creates waves of fluid motion in the perilymph within the cochlea 140. This fluid motion, in turn, activates tiny hair cells (not shown) within the cochlea 140. Activation of the hair cells causes appropriate nerve impulses to be generated and transmitted through spiral ganglion cells (not shown) and the auditory nerve 114 to the brain (also not shown), where they are perceived as sound.

[0030] As shown, cochlear implant 100 includes one or more components that are temporarily or permanently implanted in a recipient. Figure 1A 1 is shown with an external device 142 that is part of a system 10 (along with a cochlear implant 100) configured to provide power to a cochlear implant, as described below, wherein the implanted cochlear implant includes a battery that is rechargeable via a transcutaneous link.

[0031] exist Figure 1A In the illustrative arrangement of FIG, external device 142 may include a power source (not shown) housed in behind-the-ear (BTE) unit 126. External device 142 also includes components of a transcutaneous energy transfer link, referred to as an external energy transfer component. The transcutaneous energy transfer link is used to transfer power and / or data to cochlear implant 100. Various types of energy transfer, such as infrared (IR), electromagnetic, capacitive, and inductive transfer, may be used to transfer power and / or data from external device 142 to cochlear implant 100. Figure 1A In the illustrative embodiment of the invention, the external energy transfer assembly includes an external coil 130 that forms part of an inductive radio frequency (RF) communication link. The external coil 130 is typically a wire antenna coil consisting of multiple turns of electrically insulated single or multiple strands of platinum or gold wire. The external device 142 also includes a magnet (not shown) that is positioned within the turns of the external coil 130. It should be understood that Figure 1A The external devices shown in FIG are illustrative only, and other external devices may be used with embodiments of the present invention.

[0032] The cochlear implant 100 includes an internal energy delivery assembly 132 that can be placed in a depression of the temporal bone adjacent to the recipient's auricle 110. As described in detail below, the internal energy delivery assembly 132 is a component of a transcutaneous energy delivery link and receives power and / or data from an external device 142. In the illustrated embodiment, the energy delivery link comprises an inductive RF link, and the internal energy delivery assembly 132 includes a primary internal coil 136. The internal coil 136 is typically a wire antenna coil comprising multiple turns of electrically insulated single or multi-strand platinum or gold wire.

[0033] Cochlear implant 100 also includes a main implantable component 120 and an elongated electrode assembly 118. In some embodiments, internal energy delivery assembly 132 and main implantable component 120 are hermetically sealed within a biocompatible housing. In some embodiments, main implantable component 120 includes an implantable microphone assembly (not shown) and a sound processing unit (not shown) to convert sound signals received by the implantable microphone in internal energy delivery assembly 132 into data signals. That is, in some alternative embodiments, the implantable microphone assembly can be located in a separate implantable component (e.g., having its own housing assembly, etc.) that is in signal communication with main implantable component 120 (e.g., via leads between the separate implantable component and main implantable component 120, etc.). In at least some embodiments, the teachings detailed herein and / or variations thereof can be used with any type of implantable microphone arrangement.

[0034] The main implantable component 120 also includes a stimulator unit (also not shown) that generates electrical stimulation signals based on the data signals. The electrical stimulation signals are delivered to the recipient via the elongated electrode assembly 118.

[0035] The elongated electrode assembly 118 has a proximal end connected to the main implantable component 120 and a distal end that is implanted in the cochlea 140. The electrode assembly 118 extends from the main implantable component 120 through the mastoid bone 119 to the cochlea 140. In some embodiments, the electrode assembly 118 can be implanted at least in the basal region 116 and sometimes further. For example, the electrode assembly 118 can extend toward the top of the cochlea 140, known as the cochlear apex 134. In some cases, the electrode assembly 118 can be inserted into the cochlea 140 via a cochleostomy 122. In other cases, the cochleostomy can be formed through the round window 121, the oval window 112, the promontory 123, or through the apical turn 147 of the cochlea 140.

[0036] The electrode assembly 118 includes a longitudinally aligned and distally extending array 146 of electrodes 148 disposed along its length. As noted, the stimulator unit generates stimulation signals that are applied by the electrodes 148 to the cochlea 140, thereby stimulating the auditory nerve 114.

[0037] Figure 1B 1 is a side view of the cochlear implant 100 without other components of the system 10 (e.g., external components). The cochlear implant 100 includes a receiver / stimulator 180 and an electrode assembly or lead 118. The electrode assembly 118 includes a helical region 182, a transition region 184, a proximal region 186, and an intracochlear region 188. The proximal region 186 and the intracochlear region 188 form an electrode array assembly 190. In an exemplary embodiment, after the intracochlear region 188 is implanted in the cochlea, the proximal region 186 is located in the middle ear cavity of the recipient. Thus, the proximal region 186 corresponds to a middle ear cavity sub-portion of the electrode array assembly 190. The electrode array assembly 190, and in particular the intracochlear region 188 of the electrode array assembly 190, supports a plurality of electrode contacts 148. Each of these electrode contacts 148 is connected to a corresponding conductive path, such as a wire, PCB trace, etc. (not shown), which is connected to the receiver / stimulator 180 through the leads 118, through which the corresponding stimulation electrical signal for each electrode contact 148 is propagated.

[0038] Figure 2 is a side view of the electrode array assembly 190 in a curled orientation, as in situ in a patient's cochlea, with the electrode contacts 148 located on the inside of the bend. Figure 3A Depicted is a side view of a device 390 corresponding to a cochlear implant electrode array assembly, which may include Figure 1B 190 ). More specifically, in an exemplary embodiment, electrode assembly 118 includes electrode array assembly 390 rather than electrode array assembly 190 (i.e., 190 is replaced by 390). Thus, according to an exemplary embodiment, there is a cochlear implant 100 as described above, which includes electrode array assembly 390, wherein the electrodes of electrode array assembly 390 communicate with the rest of the implantable components in the cochlear implant in a conventional manner (although leads, etc. may be rewired about electrode array assembly 390 to accommodate the teachings and / or variations thereof detailed herein). Additional details of assembly 390 will now be provided.

[0039] Electrode array assembly 390 includes a cochlear implant electrode array 310 and a device 320 configured to induce trauma in the cochlea. In exemplary embodiments, the device induces a foreign body response in the cochlea. In exemplary embodiments, the trauma induces a foreign body response in the cochlea, while in other exemplary embodiments, the trauma does not induce a foreign body response. In exemplary embodiments, it induces a foreign body response in one cochlea but not the other, while in other embodiments, it induces a foreign body response in both. In exemplary embodiments, the trauma is reversible. In exemplary embodiments, the trauma is irreversible or at least not fully reversible. In exemplary embodiments, the trauma is at least 30%, 40%, 50%, 60%, 70%, 80%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or more reversible. In exemplary embodiments, the trauma is 100% reversible. In exemplary embodiments, the foreign body response exceeds that induced solely by the insertion / implantation process of inserting the cochlear electrode array. In an exemplary embodiment, a foreign body reaction is a deliberately exaggerated foreign body reaction that exceeds the foreign body reaction caused by the insertion / implantation of the electrode array. That is, the foreign body reaction is purposefully induced to be more severe than it would otherwise be. In an exemplary embodiment, a foreign body reaction is a process caused by something that is at least partially reversible, such as at least 30%, 40%, 50%, 60%, 70%, 80%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99% or more reversible. In an exemplary embodiment, a foreign body reaction is caused by something that is atraumatic. In an exemplary embodiment, a foreign body reaction is caused by something that is non-traumatic. In an exemplary embodiment, electrode array assembly 390 has some and / or all of the functionality of electrode array assembly 190, where electrode array assembly 190 corresponds to a state-of-the-art electrode array assembly and / or a variant thereof and / or an earlier model electrode array assembly. By way of example only and not limitation, the electrode array assembly 390 includes any electrode array 310 having a plurality of electrodes 148. The electrode array assembly 390 is configured such that the electrodes 148 of the electrode array 310 are in signal communication with and / or positioned within the receiver stimulator 180. Hereinafter, in alternative embodiments, any disclosure of trauma corresponds to eliciting a foreign body response, and vice versa, unless otherwise stated in the art enabling this. To be clear, this is not to say that the two are the same. Quite the contrary. The purpose of this statement is merely to provide a convenient way to convey the various concepts. It should also be noted that the two are not mutually exclusive. Trauma can induce a foreign body response.

[0040] In some embodiments, the device 320 is configured to expand to contact the wall of the cochlea. Figure 3AIn an exemplary embodiment, the device 320 is a pressure-based component. Along these lines, in an exemplary embodiment, the device 320 is configured to expand when its components are pressurized.

[0041] More specifically, device 320 includes an expandable subassembly 330 in fluid communication with a conduit 340, which in turn is in fluid communication with a pressure generator subassembly 350 (e.g., a pump coupled to a reservoir of fluid). As can be seen, pressure generator subassembly 350 includes an electrical lead port 303 that electrically connects the pressure generator subassembly to a receiver stimulator of a cochlear implant. That is, in an exemplary embodiment, component 350 may be Figure 3B Depicted is a conceptual representation of an electrode array assembly 390 inserted into the cochlea 140, the electrode array assembly 390 being configured to be prosthetically retained in the cochlea (i.e., it is configured to remain in the cochlea for a period of time concomitant with use of the prosthetic device, as opposed to temporary insertion, such as might be the case with a needle, etc.). Figure 3B A conceptual diagram is depicted depicting the intra-cochlear region 188 of the electrode array assembly 390 in the cochlea 140 and the proximal region 186 of the electrode array assembly 390 located outside the cochlea 140, wherein the conduit 340 of the device 320 extends from the inside of the cochlea 140 to the outside of the cochlea into the middle ear cavity, which is functionally represented by the dotted housing 105. It should be noted that Figure 3B and Figure 3A This diagram in is conceptual only and is provided at least for the purpose of presenting the concept of a cochlear implant electrode array having a device 320 that is only partially inserted into the cochlea. In an exemplary embodiment, the electrode array assembly is inserted into the scala tympani along with an inflatable subassembly (hereinafter referred to as an inflator) . That is, in an alternative embodiment, at least the inflator is inserted into the scala vestibuli. Thus, in an exemplary embodiment, there is an electrode array assembly that is configured such that the electrode array is insertable into the scala tympani and the inflator is insertable into the scala vestibuli. In an exemplary embodiment, the entire electrode array assembly is configured to be insertable into the scala vestibuli.

[0042] Additional details of the components of assembly 390 will now be described.

[0043] Before describing some details of the array 390, it is briefly noted that this is presented in terms of a conceptual device. For example, it can be seen that the boost pump 330 is located at the base portion of the electrode array. More precisely, it can be seen that the boost pump 330 is only located at the base portion of the electrode array. In some embodiments, the boost pump 330 is located midway along the electrode array, such as after the first 11 electrodes (thus, in an exemplary embodiment, between two groups of 11 electrodes of a 22-electrode array). In some embodiments, the boost pump can be located at the top of the electrode array. The boost pump can be located anywhere that can have practical value. It should also be noted that although this embodiment depicts the boost pump as a discrete component located only at one location, in an exemplary embodiment, multiple boost pumps can be utilized and positioned along the electrode array. It should also be noted that although the embodiments described herein detail a pressure generator 350 located near the electrode array / a portion of the electrode array, in an exemplary embodiment, the pressure generator is located away from the electrode array, such as, by way of example only and not limitation, in a receiver stimulator. Indeed, in this exemplary embodiment, a tube or catheter may extend along the electrode leads from the electrode array to the receiver stimulator (where the pump is located).

[0044] In an exemplary embodiment, the pump is an electric pump that is operated by an induction field that is transmitted transcutaneously to the receiver stimulator unit. In an exemplary embodiment, the pump can be a manually operated pump. Indeed, in exemplary embodiments where the pump is located remotely from the electrode array assembly, the receiver stimulator can be configured with a flexible member that can be repeatedly depressed through the recipient's skin. For example, the recipient can press their finger against their skin above the flexible member to pump fluid to the booster pump.

[0045] In an exemplary embodiment, the boost pump 330 is made of a titanium cylinder 332 having a closed end and an end 336 opened via a port 338. The port 338 provides fluid communication between the inside of the cylinder and the outside of the cylinder. The boost pump 330 includes four membranes 334 arranged around the longitudinal surface of the cylinder. (The membrane is depicted as a curved membrane, but in alternative embodiments, the membrane is flat or can be other shapes.) In the embodiment of the accompanying drawings, the membrane 334 covers the through-holes 333 extending through the longitudinal surface of the cylinder 332. The membrane 334 seals these holes airtightly. The membrane 334 is configured to deflect or otherwise move according to the pressure changes inside the titanium cylinder caused by the pump in the pressure generator subassembly 350. This causes pressure fluctuations in the boost pump 330. In an exemplary embodiment, this is because the pressure increase in the cylinder 332 causes one or more membranes 334 to deflect outward.

[0046] In the embodiment of the accompanying drawings, there are four separate membranes provided with the boost pump 330. As can be seen, these membranes are evenly spaced laterally around the longitudinal axis of the cylinder 332. Some embodiments may use fewer or more membranes. In exemplary embodiments, one, two, three, four, five, six, or more membranes may be utilized. In at least some embodiments, any number of membranes that can achieve the teachings detailed herein and / or variations thereof may be utilized.

[0047] exist Figures 4A to 4C In the embodiment of the present invention, membrane 334 is depicted as an individual membrane. In some exemplary embodiments, these membranes can be welded or glued or curled to cylinder 332. In an exemplary embodiment, a membrane assembly is utilized, wherein the membrane is held in a frame, and the frame is attached to cylinder 332. In at least some embodiments, any device, system or method that enables the membrane to be attached to cylinder 332 so that the detailed teachings of this article can be put into practice can be utilized. In fact, along these lines, in an exemplary embodiment, cylinder 332 includes four through holes. A single membrane sheet is wrapped around cylinder 332. An adhesion process can be utilized to adhere the membrane to cylinder 332. This process adheres a sheet to a portion of the cylinder where no hole exists. Therefore, the sheet is free to flex on the hole of cylinder 332 due to pressure changes. Therefore, four membranes are obtained from the manufacturing process using only one sheet.

[0048] Figure 5An exemplary scenario utilizing array 390 is depicted, in which two of the membranes 334 are extended / inflated outward. In reality, in at least some embodiments, all four membranes will be inflated. In some respects, this diagram is presented to convey a general concept of expansion. That said, it should be noted that in some embodiments, fewer than all membranes will actually be inflated—this can be achieved by utilizing certain types of materials that differ for some membranes compared to others (thus, more precisely, the amount of expansion can vary). A more rigid material may be used for one membrane relative to another, resulting in a different amount of deformation for a given pressure. In an exemplary embodiment, pressure generator 350 pumps an inert gas through conduit 324 to increase the pressure inside cylinder 332, thereby inflating membranes 334 outward. In an exemplary embodiment, membranes 334 inflate to contact the walls of the cochlea. In some embodiments, the fact that the membranes are in contact with the cochlear walls is sufficient to cause trauma and / or induce / trigger a foreign body reaction. In an exemplary embodiment, the membranes are repeatedly inflated and deflated to "tap" the cochlear walls, which ultimately leads to the induction of trauma and / or the induction of a foreign body reaction. In an exemplary embodiment, the membrane can be undulating so as to rub the cochlear wall back and forth. In this regard, in an exemplary embodiment, the membrane can be configured such that upon reaching a certain pressure, one side of the membrane will expand more than the other side, and thus this expansion will rub the membrane wall in at least one direction because the other portion that is no longer expanding will be fixed relative to the wall.

[0049] In exemplary embodiments, the membrane may have barbs or spikes or protuberances or abrasive surfaces thereon that, when expanded against the wall of the cochlea, would cause similar irritation, thereby resulting in a traumatic or foreign body reaction.

[0050] It should be pointed out that Figure 3A-Figure 5The embodiments are merely exemplary. In some alternative embodiments, the electrode array may be configured with other types of devices that will cause trauma and / or induce / trigger a foreign body reaction. By way of example only, and not limitation, optical / light-generating devices may be utilized to cause trauma and / or to induce / trigger a foreign body reaction. In this regard, optical fibers, etc., may be utilized to route light into the interior of the cochlea, which will cause / trigger the trauma / reaction. In alternative embodiments, the electrode array may be a conventional cochlear implant electrode array, wherein the electrodes are utilized to cause / trigger the trauma / reaction. In exemplary embodiments, the cochlear implant may be configured such that the electrode array may be utilized to generate current at higher amperage levels than the current utilized to induce auditory perception in a properly functioning cochlear implant, and / or may be utilized to apply alternating current frequencies that are higher and / or lower than the alternating current frequencies used to induce auditory perception in a properly functioning cochlear implant. In exemplary embodiments, the cochlear implant may be configured such that the electrode array may be utilized to generate direct current, at least for a limited period of time. Direct current is not a good type of current to apply to tissue within the human body. In this regard, direct current can be exploited to cause / induce trauma / reactions.

[0051] In at least some exemplary embodiments, any device, system, and / or method that can cause trauma and / or induce a foreign body response or any other type of physical phenomenon in a human being practicing one or more of the teachings detailed herein can be utilized. Moreover, in some embodiments, any device that can manage the blood labyrinth barrier can be utilized, even if it does not cause trauma and / or a foreign body response. In some embodiments, any device that can cause inflammation or otherwise alter the blood labyrinth barrier (e.g., by inflaming the blood labyrinth barrier) can be used.

[0052] Figure 6is a perspective view of an exemplary internal component 344 of an implant having a trauma-inducing / foreign body response-inducing / inducing component in the middle ear when implanted. The internal component 344 includes an internal receiver unit 632, a modified stimulator unit 620, and a stimulation arrangement 650. In an exemplary embodiment, the modified stimulator unit can be a stimulator unit of a middle ear implant that has been modified, for example by reprogramming, to actuate the stimulation arrangement 650 rather than actuating a middle ear actuator, etc. In some alternative embodiments, the stimulator unit can be a processor having an output to a cable 328, wherein the processor receives input via the receiver unit 632, processes the input according to an algorithm therein (e.g., if a frequency is received at a certain amplitude, the processor places the signal in a certain manner to control the stimulation arrangement 650). As shown, the receiver unit 632 includes an internal coil (not shown) and a magnet 320 fixed relative to the internal coil. In some embodiments, the internal receiver unit 632 and the modified stimulator unit 620 are hermetically sealed within a biocompatible housing. For ease of illustration, the diagram has been removed from the figure. Figure 6 The housing is omitted.

[0053] The stimulator unit 620 is connected to a stimulation arrangement 650 via a cable 328. The stimulation arrangement 650 includes an actuator assembly 661, an actuator assembly mounting member 651, and an actuator assembly positioning arm 652. In an exemplary embodiment, the actuator assembly mounting member 651 is configured to be positioned in an artificial channel in the mastoid bone and to be secured to the mastoid bone of a recipient. Figure 6 As indicated by the curved arrows in FIG. , the actuator assembly mounting member 651 and the actuator assembly 661 are configured so that the actuator assembly positioning arm 652 can be articulated relative to those components. Figure 6 As indicated by the straight arrow in , the actuator assembly positioning arm 652 is configured to telescope to provide longitudinal adjustment between the actuator assembly 661 and the actuator assembly mounting member 651.

[0054] In operation, actuator 661 applies stimulation to the round window and / or oval window of the cochlea and / or another component of the cochlear outer wall in a manner that causes trauma and / or induces / triggers a foreign body reaction. In some embodiments, the body of actuator assembly 661 remains fixed relative to the outer wall of the cochlea, and one or two of the output arms (two are shown, one for the round window and one for the oval window, but in some embodiments, only one output is used for the round window or oval window) apply stimulation to the respective round and oval windows. That is, in alternative embodiments, the actuator assembly mounting member, along with other components, can swing or otherwise cause actuator 661 to strike the outer wall of the cochlea and / or the round window and / or oval window, much like someone hitting a board with a hammer or the like (or a manhole cover, with a hammer, etc.). In exemplary embodiments, actuator 661 is replaced by some other form of stimulation-inducing component, such as, for example, a blunt object or a pointed object. In at least some exemplary embodiments, any component or configuration capable of inducing trauma and / or eliciting a foreign body reaction can be utilized.

[0055] In exemplary embodiments, the devices, systems, and / or methods described herein are configured to provide energy that generates waves of fluid motion in the perilymph, thereby inducing trauma / eliciting a foreign body reaction in, at, or in association with the hair cells of the organ of Corti, and / or at the organ of Corti. In exemplary embodiments, this is achieved by vibrations of sufficient magnitude, or lack thereof, at certain frequencies to induce the aforementioned trauma and / or foreign body reaction. In exemplary embodiments, this may correspond to subsonic or supersonic frequencies provided for a sufficient period of time to cause trauma and / or induce a foreign body reaction. In some instances, sounds may be audible, but only briefly.

[0056] Figure 7 Describes the use of Figure 6 A high-level conceptual diagram of a device is shown in which an actuator 361 is positioned outside the cochlea 140. In this exemplary embodiment, the actuator 361 is configured to apply a compressive and / or tensile force to the round window 121 and / or to the oval window 122. This can be done in a synchronized manner or separately. In some embodiments, the force corresponds to a tapping force rather than a more steady force (e.g., similar to using a hammer, etc.).

[0057] In view of the above, it can be seen that, in an exemplary embodiment, there is an apparatus comprising an implantable device configured to cause trauma to the inner ear and / or middle ear of a recipient and / or induce an inner ear foreign body reaction therein. Figure 3A In some exemplary embodiments, the implantable device is a cochlear implant. Figure 6 As can be seen from the embodiments, in some embodiments, the implantable device is a component that is implanted in the middle ear.

[0058] In view of the above, together with the following teachings, it will be seen that in exemplary embodiments, there is a device, system and / or method that can inflame and / or anti-inflammate the BLB to control or otherwise manage the distribution of compounds or other substances in human structures (such as the cochlea, eyes, kidneys, etc.). In exemplary embodiments, there are some devices, systems and / or methods that are configured to achieve a point of control over the BLB so that the BLB can be opened and / or closed, thereby affecting the permeability of the barrier to the substance in question. Such devices, systems and / or methods can achieve systemic delivery of drugs or substances, achieving flushing of toxins from the structure in question, such as for example for ear protection. This can also control or otherwise manage drug distribution and drug levels in the cochlea.

[0059] As noted above, in some embodiments, a mechanical stimulation / mechanical force output device can be utilized to induce a trauma / foreign body reaction. Also as noted above, in some embodiments, an electrical stimulation / electrical output device can be utilized to induce a trauma / foreign body reaction. Thus, in exemplary embodiments, the implantable device is configured to extend into the recipient's cochlea and electrically stimulate tissue within the recipient to induce trauma and / or elicit a foreign body reaction. Further, consistent with the above embodiments, in some exemplary embodiments, the implantable device is a cochlear electrode array that is configured to extend into the recipient's cochlea and electrically stimulate tissue within the cochlea in various ways to induce auditory perception (consistent with the typical operation of a cochlear implant) and electrically stimulate tissue within the recipient to induce trauma and / or elicit a foreign body reaction (which is inconsistent with the typical operation of a cochlear implant). It should be noted that while some embodiments utilize electrodes located within the cochlea to produce trauma and / or elicit a foreign body reaction, in some embodiments, only electrodes located outside the cochlea are utilized. By way of example only and not limitation, in exemplary embodiments, one or more electrodes may be placed against the outer wall of the cochlea in the middle ear, which may be utilized to induce trauma and / or elicit a foreign body response. In exemplary embodiments, the electrode(s) may be ECE / hard ball / return. In exemplary embodiments, the electrode(s) may be placed against or otherwise adjacent to the round window, oval window, etc. The electrodes may be placed against or otherwise adjacent to the round window niche. Additionally, in some embodiments, the electrodes may be in communication with electrodes also within the cochlea to close the circuit. Moreover, in some embodiments, the hard ball or return electrode / ECE may be utilized to close the circuit via electrodes located in the middle ear and / or electrodes located in the cochlea. In at least some exemplary embodiments, any arrangement that may be utilized to establish electrical stimulation to induce trauma and / or elicit a foreign body response in the inner and / or middle ear of a recipient may be utilized. Figure 3A In an exemplary embodiment, an implantable device is shown as part of a cochlear implant that is configured to extend into a recipient's cochlea and electrically stimulate tissue in the cochlea in various ways to induce auditory perception, as well as electrically stimulate tissue within the recipient to induce trauma and / or trigger a foreign body reaction without inducing auditory perception. It should be noted that in some embodiments, even a normal electrode array without a booster pump 330 or other mechanical stimulation component can be utilized in at least some exemplary embodiments to induce trauma and / or trigger a foreign body reaction without inducing auditory perception. The key point here is that inducing trauma / triggering a foreign body reaction without causing the recipient to "hear" anything can have practical value. That is, in some embodiments, the trauma / foreign body reaction can result in some auditory perception associated therewith.

[0060] In some embodiments, the implantable device is configured to passively cause trauma and / or elicit a foreign body response. In some embodiments, the implantable device is configured to actively cause trauma and / or elicit a foreign body response.

[0061] Figure 8 Exemplary alternative embodiments are depicted in which the implantable device is a drug delivery device / substance delivery device in combination with a cochlear implant electrode array, but in other embodiments, the implantable device is solely a drug delivery device. (Similarly, the mechanical stimulation device / subsystem detailed above can be utilized in an implantable device that is itself such (e.g., without the electrode array to induce auditory perception). The same is true with respect to the optical system / light system, etc. Any disclosure of any configuration herein can be used independently of or in combination with any other component disclosed herein.)

[0062] Figure 8 An assembly 230 is shown comprising an elongated member 231 corresponding to the electrode array (intra-cochlear portion) having a distal end 233 which is first inserted into the cochlea when the assembly 230 is inserted. Figure 8 As depicted in FIG, the collar 240 surrounds the lead 21 (which may be Figure 1A The loop 240 is positioned (e.g., slidably or fixedly) by a guide wire (e.g., a guide wire). The loop 240 is used to deliver one or more substances (drugs or bioactive substances or other substances) to a location just outside the cochlea (e.g., to the round or oval window, or to another location such as a cochleostomy or any other practical location). In some embodiments, the delivered substance is a substance that triggers a foreign body reaction and / or causes trauma. In some embodiments, the delivered substance is a therapeutic substance. More on this below.

[0063] The collar 240 has a stepped outer surface 241 defined by two cylindrical portions 242 and 243. In the depicted embodiment, the collar 240 is symmetrical about its longitudinal axis and has parallel proximal and distal ends 244 and 245. The outlet of the collar 240 is located in the distal end 245 of the collar 240. In the depicted embodiment, the collar 240 also has an inlet 250 in the proximal end 244 of the collar 240. The inlet and outlet are in communication with each other, such as fluid communication. Figure 8 As depicted in FIG, the outlet 246 of the collar 240 comprises an annular opening in the distal end 245 of the collar. A chamber 247 within the collar extends from the outlet 246 back into the collar 240. Since the outlet 246 is depicted as an annular opening, the chamber 247 is also annular and thus comprises a cylindrical chamber having an outer surface and an inner surface and extending from the outlet 246 back into the collar. However, it should be understood that the outlet and chamber need not be annular to fall within the scope of the present application.

[0064] The annular chamber 247 has a frustoconical region 248 where the outer and inner walls of the chamber 247 are displaced away from the longitudinal axis of the collar 240, and another cylindrical region 249 distal to the outlet. In this embodiment, the inlet 250 comprises a line extending from the proximal end 244 of the collar into the chamber 247. The inlet 250 is adjacent to the outer wall 241 of the collar 240.

[0065] The distal end 233 of the elongated member can be first inserted into the cochlear incision of the implantee during implant placement. The chamber in the collar serves as a reservoir for the bioactive substance. The bioactive substance in the chamber diffuses from the chamber into the implantee through the semipermeable membrane 270 in the outlet 246. The membrane 270 allows the bioactive substance to leach from the chamber to the desired site of action of the bioactive substance during and / or after implantation.

[0066] When the bioactive substance is carried in or includes a fluid, the semipermeable membrane 270 allows the fluid to leach or diffuse therethrough.

[0067] The membrane 270 may act as a valve or metering device that allows fluid to leave the chamber but prevents, or at least substantially prevents, fluid from flowing from outside the chamber back into the chamber within the body.

[0068] Figure 8 The embodiments of present exemplary embodiments wherein the trauma-inducing / foreign body response-inducing component is located external to the cochlea. Figure 8 The embodiment of the present invention presents a substance delivery device that causes trauma / induces a foreign body reaction, but in alternative embodiments, the collar 240 can instead be a mechanical device, etc. and / or an electrical stimulation device, etc. In an exemplary embodiment, the expansion system detailed above can be located at the left surface of the collar to induce mechanical stimulation on the outer wall of the cochlea and / or on the round window and / or oval window of the cochlea, etc.

[0069] Figure 9 Another exemplary embodiment of an electrode array 930 is presented, which includes electrodes 44 and also includes a conduit 933 through which a substance is ejected, indicated by the indicator / arrow "A". This exemplary embodiment presents a device that can enable a substance to be directed / supplied directly into the cochlea, which is similar to Figure 8 In contrast to the embodiment of Figure 8 In an embodiment, the substance is provided at a location outside the cochlea and can diffuse through the wall and / or through the window into the interior of the cochlea. A corollary to this is that in an exemplary embodiment, the collar is configured with a needle or the like extending from outside the cochlea into the cochlea. In practice, Figure 9It may conceptually represent a needle that may be mounted at the outlet of the collar 240 (minus electrodes, etc.) to inject or otherwise deliver substances directly into the cochlea.

[0070] It should also be noted that in exemplary embodiments, the electrode array may include components that enable movement of the electrode array within the cochlea. In exemplary embodiments, magnetostrictive materials may be utilized to enable the length of the electrode array to move like a whip or vibrate the electrode array to cause trauma and / or induce a foreign body reaction due to contact with the cochlear wall and / or movement of fluid within the cochlea caused by peripheral lymph that causes trauma to the cochlear wall.

[0071] It should be noted that because the boundary between the inner ear and the middle ear may not necessarily be clearly defined (when the wall of the cochlea ceases to be the middle ear and becomes the inner ear), unless otherwise indicated, any disclosure herein regarding inner ear trauma and / or foreign body reaction in the inner ear (cochlea) also corresponds to such disclosure at the boundary between the inner ear and the middle ear (e.g., the cochlear wall). The same applies to any reference to middle ear trauma and / or middle ear foreign body reaction.

[0072] As will be described in more detail below, there may be practical value in determining whether a condition exists within a recipient that warrants an action to cause trauma and / or elicit a foreign body reaction, as opposed to another condition where, if the condition were absent, the action would not be warranted. Thus, in an exemplary embodiment, there is an implantable device configured to detect a physical phenomenon inside the cochlea. In this exemplary embodiment, the implantable device is configured to cause trauma and / or elicit a foreign body reaction when the physical phenomenon is detected. A corollary of this is that, in an exemplary embodiment, the implantable device is configured not to cause trauma and / or elicit a foreign body reaction when the physical phenomenon is not detected. In this regard, in an exemplary embodiment, instead of element 330 being a booster pump, element 330 may be a detector or receiver. In an exemplary embodiment, element 330 may include a diaphragm or the like that can respond to pressure changes inside the cochlea. Because diaphragm 330 is in fluid communication with element 350, in exemplary embodiments, element 350 can be a pressure detector or the like that can assess pressure inside the cochlea, as the pressure inside the detector or receiver will change as the pressure inside the cochlea changes due to the elastic properties / flexibility of diaphragm 334. Indeed, in exemplary embodiments, embodiments can be utilized where element 334 is a membrane, and pump 350 can be a combination pump / pressure detector. In exemplary embodiments, upon determining that the pressure inside the inner ear has changed or otherwise been at a certain value for a particular period of time, this would indicate a phenomenon (e.g., disease, infection, etc.), because pressure detector 350 communicates signals with the processor of the receiver simulator via lead output 303, and thus a processor programmed to evaluate the output signal can determine that the pressure has changed for a sufficiently long period of time that trauma should be caused and / or a foreign body reaction should be triggered.

[0073] In an exemplary embodiment, element 330 may be a temperature sensor, or, in an exemplary embodiment, the temperature sensor may be a Figure 3A In an exemplary embodiment, a temperature sensor can detect the temperature inside the cochlea. Monitoring this can determine whether there is an increase in temperature inside the cochlea, which can indicate an infection inside the cochlea, etc.

[0074] Figure 3A In an exemplary embodiment, wherein element 330 is a pressure detector rather than a trauma-inducing / foreign body reaction-inducing device, in some embodiments, electrode 148 can be utilized to induce trauma, etc. That is, in exemplary embodiments, the trauma is not caused by an implantable device, but rather by another type of device. In this regard, in exemplary embodiments, the implantable device is a device that only detects physical phenomena.

[0075] In at least some exemplary embodiments, the teachings detailed herein in connection with causing trauma and / or inducing a foreign body response are directed to altering the recipient's blood labyrinth barrier. In exemplary embodiments, there is a Figure 10 , the method includes a method act 1010 that includes monitoring a physical phenomenon inside the cochlea of ​​a recipient. In an exemplary embodiment, the monitoring act can be performed using the devices detailed above (such as pressure receivers, temperature receivers, etc.). More clearly, this can be performed by measuring the phenomenon with a probe outside the cochlea - the cochlea is the location of the phenomenon being addressed. In some embodiments, this is performed by measuring cochlear health from the round window niche or other additional cochlear locations as well as locations within the cochlea. Therefore, in an exemplary embodiment, there is an implantable device that is configured to detect a physical phenomenon inside the cochlea by monitoring at the round window niche of a recipient, and then opening the tight junctions of cells at the round window when the physical phenomenon is detected. In an exemplary embodiment, a method of using such a device can include implementing the device to achieve the functionality just described and then delivering a therapeutic substance at the opened junctions.

[0076] Any location from which internal cochlear phenomena can be monitored, as well as other extra-cochlear locations, can be used. In addition, it should be noted that claim 1010 also includes the use of latent variables. For example, it is outside the cochlea associated with the body, rather than inside the cochlea. In an exemplary embodiment, there can be a device that captures, or comes into contact with, or is otherwise directly exposed to, the fluid inside the cochlea, and can analyze the fluid to determine whether a physical phenomenon is present or has changed within the recipient's cochlea. The physical phenomenon can be any phenomenon that indicates an adverse occurrence inside the cochlea, such as an infection caused by the insertion of a cochlear implant, or such as a reaction to chemotherapy that causes damage to the inner ear tissue. In fact, the physical phenomenon can be the presence of a chemotherapeutic substance. In such an exemplary embodiment, which can be a platinum-based chemotherapy, it tends to cause hearing loss in some cases.

[0077] Method 1000 also includes method act 1020, which includes inducing a change in the recipient's blood-labyrinth barrier based on the monitored physical phenomenon. In this regard, in exemplary embodiments, the blood-labyrinth barrier can control or otherwise influence the amount of chemicals that enter the inner ear or otherwise reach the recipient's auditory system when introduced outside the auditory system. Referring to the chemotherapy example, in exemplary embodiments, there is practical value in preventing or otherwise reducing the amount of chemotherapy chemicals that reach the auditory system in general, and the inner ear and / or middle ear in particular. Thus, by altering the blood-labyrinth barrier, the amount of chemicals that reach the auditory system can potentially be reduced relative to a scenario in which no alteration occurs. Thus, in exemplary embodiments, the physical phenomenon is one related to ototoxicity. In exemplary embodiments, trauma and / or induction of a foreign body reaction can cause the blood-labyrinth barrier to change. By way of example only, and not limitation, inducing trauma within the inner ear can cause the blood-labyrinth barrier to become more "porous," thereby reducing the amount of chemotherapy chemicals that accumulate in the inner ear or auditory system relative to a scenario in which no alteration occurs. That is, in some embodiments, by making the barrier more porous, the outflow of chemicals will be increased relative to what would otherwise be the case. That is, in some alternative embodiments, it may be practical to maintain the blood labyrinth barrier so that the amount of chemicals reaching the inner ear is limited in a manner that goes beyond initially controlling accumulation. That is, rather than opening the barrier to flush the inner ear, the barrier is utilized to prevent accumulation. This may correspond to modifying the blood labyrinth barrier such that the porosity of the barrier is actually reduced relative to what would otherwise occur without the modification.

[0078] In certain example embodiments, adjustment of the BLB can increase or decrease the rate of material transfer from the interior of the structure to the exterior of the structure relative to the absence of the adjustment in certain example embodiments. The rate increases by 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 225, 250, 275, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, 400, 410, 420, 430, 440, 450, 460, 470, 480, 490, 500, 510, 510, 520, 530, 540, 550, 560, 570, 580, 590, 600 0, 350, 400, 450, 500, 550, 600, 650, 700, 750, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2500, 3000, 3500, 4000, 4500, 5000, 5500, 6000, 7000, 8000, 9000 or 10000 or more. In an exemplary embodiment, the rate is reduced by 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, 55, 60, 65, 70, 75, 80, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99%, or 100%.

[0079] In view of the foregoing, it will be appreciated that, in exemplary embodiments, the alteration in the blood labyrinth barrier is an increase in its permeability, and that, due to the increase in permeability, the amount and / or concentration of the substance in the cochlea is reduced relative to a situation in which the increase is not present. More specifically, consistent with the case of chemotherapy, in exemplary embodiments, the substance is a drug that is introduced into the recipient's body at a location distal to the cochlea and is a drug that is unrelated to the hearing disease. By way of example only and not limitation, the substance may be a drug that is introduced into the recipient's arm or groin. In exemplary embodiments, the substance may be a drug that is introduced into the recipient's mouth, such as by taking a pill or the like. In exemplary embodiments, the substance may be a drug that is introduced through the recipient's nose, such as something that is inhaled (like what was used in Dawn of the Planet of the Apes).

[0080] It should also be noted that features of method 1000 can be applied in alternative embodiments not associated with the cochlea, but rather, for example, in embodiments associated with, for example, the kidney. In this regard, the method of claim 1000 can be modified to monitor physical phenomena within the kidney in a scenario of managing or otherwise reducing the occurrence of aminoglycoside toxicity. Indeed, in an exemplary embodiment, the teachings detailed herein can be utilized in connection with a bionic eye / retinal implant. In this regard, instead of an electrode array associated with a cochlear implant, an electrode array is associated with a retinal implant, and the associated apparatus detailed herein is associated therewith and modified for use in or around the recipient's eye.

[0081] It should be noted that although the above embodiments focus on substances that are drugs, in alternative embodiments, the substance may be another type of substance other than a drug.

[0082] In contrast, in exemplary embodiments, the alteration of the blood-labyrinth barrier can be an increase in its permeability, and due to the increased permeability, the amount and / or concentration of the substance in the cochlea is increased relative to a situation in which the increased permeability does not occur. By way of example only and not limitation, in exemplary embodiments, such as in the case of providing an oral medication to a recipient, the oral medication being configured to control or otherwise treat an infection in the cochlea associated with the implantation of a cochlear implant, in exemplary embodiments, by increasing the permeability of the barrier, more of the medication can reach the recipient's cochlea / inner ear / auditory system and, therefore, may be more effective relative to a situation in which the barrier adjustment does not occur, all other things being equal (e.g., the amount of medication initially taken, the recipient's height, weight, body shape, metabolism, etc.).

[0083] In an exemplary embodiment, the substance is a drug that is introduced into the recipient's body at a location distal to the cochlea and is a drug related to a hearing disease / is a drug related to the treatment of the recipient's hearing system. That is, for chemotherapy examples, etc., in exemplary embodiments, the drug is a drug that is not related to hearing diseases. Further, in exemplary embodiments, such as with respect to the kidneys, the drug can be a drug that is not related to kidney diseases. In exemplary embodiments where the teachings herein are directed to the eyes, the drug can be a drug that is not related to eye diseases. Of course, where the teachings detailed herein are applied to the above-mentioned physical structures of the recipient, the drug or substance, etc. can be related to those structures.

[0084] The above embodiments have been directed to increasing the permeability of the blood labyrinth barrier. In some embodiments, the method is directed to reducing the permeability of the blood labyrinth barrier. Thus, in an exemplary embodiment, method action 1020 causes the permeability of the barrier to be reduced. In such an exemplary embodiment, the amount and / or concentration of the substance in the cochlea is increased due to the reduced permeability, relative to a situation in which there is no reduction in permeability. In an exemplary embodiment, in a scenario in which the substance is a drug introduced into the system at a location inside the cochlea, reducing the permeability of the BLB (or at least in some embodiments, preventing an increase in permeability or at least limiting an increase in permeability relative to a situation in which the actions detailed herein are not taken - unless otherwise stated, any disclosure herein regarding reducing BLB permeability corresponds to the disclosure in the other two situations) has practical value in a scenario in which the substance is a drug introduced into the system at a location inside the cochlea and / or adjacent to the cochlea. In an exemplary embodiment, there is a method action that is to stop active stimulation for hearing and / or increase active stimulation for hearing (including activating it) to affect leakage associated with the BLB (e.g., in some cases, the stimulation may cause the BLB to leak, in other cases, the absence of stimulation may cause the BLB to leak). Similarly, in some cases, closing the BLB / tightening the BLB may reduce the elimination of the drug and / or increase its half-life, thereby causing it to diffuse further toward the apex. Conversely, in some embodiments, for example, if we only want to treat the base, controlling the BLB may be utilized to target a specific location, and the opposite of the aforementioned embodiment may be applied, where the barrier is opened to limit the diffusion distance of the drug or other therapeutic substance at the apex of the cochlea.

[0085] By way of example only and not limitation, Figure 9 Examples or such as Figure 8 In an embodiment, a therapeutic drug, such as an anti-rejection drug, can be delivered via an electrode array that delivers the therapeutic substance to the outside of the cochlea, but the therapeutic substance diffuses through the cochlear wall to the inside of the cochlea and is therefore delivered to a location close to the cochlea. The therapeutic drug can be a drug that has practical value in preventing at least some of the drug from leaching or otherwise diffusing or otherwise leaving the cochlea. That is, this can be a drug that has therapeutic value in maintaining the concentration and / or amount in the cochlea at a higher level than would be the case if the drug were allowed to escape from the cochlea. Therefore, all other things being equal, a change in the blood-labyrinth barrier that lowers the BLB can limit the amount of therapeutic substance that escapes from the cochlea relative to a situation where such a change is not present. That is, in exemplary embodiments, simply preventing the BLB from becoming more permeable or even limiting the amount of increase in permeability can also have practical value, such as, for example, preserving residual hearing.

[0086] Figure 11Another exemplary method is provided, method 1100, which includes method action 1110, which corresponds to method action 1010 described in detail above. Method 1100 also includes method action 1120, which includes the action of managing the recipient's BLB based on the monitored physical phenomenon. In this regard, management can include increasing permeability, limiting the reduction of permeability relative to the situation where there is no management, or preventing the reduction of permeability. It should be noted that in at least some exemplary embodiments described in detail herein, unless otherwise specified, any disclosure of increasing permeability herein corresponds to the disclosure of the other two. Similarly, management can include reducing permeability, limiting the increase of permeability relative to the situation where there is no management, or preventing the increase of permeability. It should be noted that in at least some exemplary embodiments described in detail herein, unless otherwise specified, any disclosure of reducing permeability herein corresponds to the disclosure of the other two.

[0087] It should be noted that, in at least some exemplary embodiments, the act of increasing the permeability of the BLB can be achieved by introducing trauma and / or otherwise inducing a foreign body reaction or otherwise providing an irritant to the tissue. In some exemplary embodiments, the act of decreasing the permeability of the BLB can be achieved by removing the trauma or otherwise alleviating the trauma or otherwise removing the resulting foreign body reaction or otherwise alleviating the resulting body reaction or otherwise removing the irritant from the tissue. In exemplary embodiments, this can be performed at least in part by reducing the trauma through the application of an active chemical, wherein the trauma is reduced by applying any other therapeutic or other useful substance.

[0088] Any disclosure that an increase in the amount and / or concentration of a substance due to administration also corresponds to disclosure that a decrease in the amount and / or concentration is prevented or that the decrease in the amount and / or concentration is limited relative to a situation in the absence of administration. In addition, any disclosure that a decrease in the amount and / or concentration of a substance due to administration also corresponds to disclosure that an increase in the amount and / or concentration is prevented, wherein the increase in the amount and / or concentration is limited relative to a situation in the absence of administration.

[0089] It should be noted that the act of inducing changes or otherwise managing the recipient's BLB can be performed via injection of inflammatory and / or anti-inflammatory compounds into the scala tympani of the cochlea. In an exemplary embodiment, this can be performed using an exemplary embodiment of the apparatus detailed above, such as Figure 9 In an exemplary embodiment, this can be done manually using a needle or the like / syringe assembly or the like. For example, this can be done during surgery to implant a cochlear implant or other hearing prosthesis.

[0090] Figure 12An exemplary algorithm for an exemplary method, method 1200, is presented, which includes method act 1210, which includes an act of administering a therapeutic substance to a person. This can be done according to any of the teachings detailed herein, such as intravenously, orally, etc. This can be done using a combined drug delivery system and prosthesis. This can be done using a separate, implantable drug delivery system separate from the prosthesis. This can be done at or near the body structure in question, or remotely.

[0091] Method 1200 also includes method action 1220, which includes causing trauma and / or inducing a foreign body response in or near a human anatomical structure, thereby adjusting the concentration and / or amount of a therapeutic substance in the anatomical structure relative to a situation in which the trauma and / or foreign body response is not present.

[0092] In embodiments, the adjustment is a decrease or increase in the amount and / or concentration of the therapeutic substance in the anatomical structure relative to a situation without trauma and / or foreign body reaction. In exemplary embodiments, the increase results in an increase of 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, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 225, 250, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, 400, 410, 420, 430, 440, 450, 460, 470, 480, 490, 500, 510, 520, 530, 540, 550, 560, 570, 580, 590, 600, 610, 620, 630, 640, 650, 660, 670, 680, 690, 701 5. 300, 350, 400, 450, 500, 550, 600, 650, 700, 750, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2500, 3000, 3500, 4000, 4500, 5000, 5500, 6000, 7000, 8000, 9000 or 10000 or more. In exemplary embodiments, the reducing results in a 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, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100% reduction.

[0093] In an exemplary embodiment, the anatomical structure may be a cochlea, a kidney, an eye, a heart valve, or the like.

[0094] In an exemplary embodiment, the anatomical structure may be the cochlea, and the person is a recipient of a cochlear implant comprising an electrode array inserted into the cochlea. Figure 8 Consistent with the embodiments of the present invention, cochlear implants are devices that cause trauma and / or induce a foreign body reaction.

[0095] The teachings detailed herein can be combined with intelligent systems, etc., to work with the recipient to enhance drug delivery protocols. By way of example only, and not limitation, exemplary embodiments may require intentionally driving inflammation in the cochlea through electrical stimulation via existing electrodes, other electrodes, or other systems such as optodes. Drugs can then be delivered orally and / or systemically via intravenous injection, and the drugs will be able to reach the cochlea better than in the absence of the aforementioned driven inflammation. Inflammation can be achieved by causing trauma and / or triggering a foreign body reaction. In exemplary embodiments, the medical regimen can be implemented with the assistance of the recipient or with the recipient's interaction. By way of example only, and not limitation, reminders such as daily, weekly, monthly, hourly, or several-hour reminders can be provided to the recipient, such as automatic reminders to take pills at a certain time. At a later time, a few minutes, a few hours, or even a few days later, the intelligent device can ask the recipient whether he or she has taken the pills. If the answer is yes, the trauma and / or foreign body reaction is initiated. In an exemplary embodiment, the recipient may instead input the time at which he or she will take the pill, and the smart device will then initiate a timed countdown, the end of which will result in an inflection that causes a foreign body reaction and / or trauma using the implanted device. In an exemplary embodiment, the smart device is a prosthesis. In an exemplary embodiment, the prosthesis may provide an artificially induced auditory perception asking a question such as "Have you taken your pill?" After a "yes" indication (which may simply be the recipient saying "yes"), the prosthesis is configured to analyze the captured sound and may analyze it as an affirmative answer, or in alternative embodiments, input to the prosthesis would be via a smartphone or smart device, or even a dumb device or remote assistant, or via a button on the prosthesis (such as a button on an earpiece, etc.).

[0096] In view of the above, Figure 13 An exemplary method, method 1300, comprising an algorithm according to an exemplary embodiment is presented. Method 1300 comprises method action 1310 comprising: providing a cochlear implant and / or a method such as Figure 14 A supporting device thereof, such as a smart phone as can be seen in FIG, automatically provides at least one of a reminder or an inquiry to the person, guiding the person to perform an action of administering a therapeutic substance to the person (or it can be taking a pill).

[0097] Method 1300 also includes method act 1320, which includes: in response to the automatic provision, receiving feedback from the person indicating that the person has administered the therapeutic substance to him / herself, and thereby performing the act (of method 1200) of administering the therapeutic substance to the person.

[0098] Method 1300 also includes causing trauma and / or a foreign body reaction using the cochlear implant based on the received feedback, corresponding to method act 1220 .

[0099] Figure 14 An exemplary system, system 2100, is presented, which can be utilized in exemplary embodiments of performing method 1300 or any other method detailed herein, where an input or controller associated therewith is present. System 2100 includes a prosthesis 100 attached to a recipient 99 and in signal communication with a smartphone 2400 via a wireless link 2300. It should be noted that in some exemplary embodiments, a wired link may be utilized instead of a wireless link. This may be useful in such exemplary embodiments due to the fact that extraneous signals in the RF spectrum are unlikely to initiate one or more of the actions detailed herein. In other words, only something hardwired to smartphone 2400 can be utilized to control the prosthesis. In an exemplary embodiment, prosthesis 10 is a cochlear implant. That is, in an exemplary embodiment, the prosthesis may be another of the devices detailed herein, such as the dedicated drug delivery and / or dedicated trauma induction / foreign body response induction devices and / or variations thereof. In an exemplary embodiment, the smartphone 2400 may provide an indicator of the method 1300, such as by presenting it in a text message on its screen or presenting it through an audio system. In an exemplary embodiment, the smartphone 2400 utilizes the input from the recipient according to the input associated with the method 1300. Although Figure 14 The embodiment of the present invention presents the use of a smartphone 2400, but in alternative embodiments, element 2400 need not be a smart device. Element 2400 can be a dumb device or a remote assistant for a prosthesis. Any device, system, and / or method capable of implementing one or more of the teachings detailed herein can be used in at least some exemplary embodiments.

[0100] It should be noted that in at least some exemplary embodiments, the act of causing trauma and / or a foreign body reaction is performed by applying a stimulus to a structure of the person. In exemplary embodiments, this may be a mechanical stimulus, such as Figure 3A In an exemplary embodiment, this may be a chemical irritant. In an exemplary embodiment, the drug delivery device detailed above and / or variations thereof may be utilized to deliver the irritant. That is, in an exemplary embodiment, the drug delivery device may be modified to deliver the irritant. Figure 3A and Figure 7 By way of example only and not limitation, a chemical irritant may be provided on the surface of the balloon, and when the balloon is inflated and thereby contacts the cochlear wall, the chemical interacts with the cochlear wall to cause trauma. Figure 7Devices can be utilized to exude chemical stimulants onto the circular and / or oval walls of the cochlea, or otherwise onto the wall / barrier between the middle ear and the inner ear.

[0101] In an exemplary embodiment, the stimulus may be a sound stimulus, such as an ultrasound device. In an exemplary embodiment, the stimulus may be a surface configured to induce irritation. While the embodiments detailed above utilize moving parts focused on active trauma inducing devices, in exemplary embodiments, the prostheses detailed herein may be more of a passive arrangement. In this regard, in exemplary embodiments, a surface, etc. may be extended to contact the recipient's tissue, but after that, nothing occurs relative to movement of the surface via active action. Instead, normal movement of the recipient may be utilized to induce irritation, such as, for example, that caused by sand in an oyster. For example, in an exemplary embodiment, Figure 3A The balloon can simply expand to contact the wall and remain expanded. When the recipient moves, or indeed, when the recipient is exposed to sound, the fluid's motional waves may move the balloon in an irritating manner. Instead of a balloon, a mechanical device can extend to contact the cell wall, such as a telescopic member that extends in an orthogonal direction or at an acute angle to the longitudinal direction of the (local) array, so as to be positioned to cause irritation of the cochlear wall. In exemplary embodiments, this can be a spring-loaded device. In exemplary embodiments, magnetostrictive materials can be utilized, which controllably deform under the influence of an electric current, for example, to contact the tissue in various ways and then retract from contact. In some embodiments, a motor or the like can be utilized to physically move the structure relative to the electrode array. By way of example only, and not limitation, a series of wire-like structures can actually extend away from the longitudinal axis of the array, which can be supported in a ring or the like. The motor can rotate the ring, but at a speed that is slow or fast enough to move the wires. When the wires scrape or otherwise move along the cochlear wall, they may cause some trauma or otherwise trigger a foreign body reaction. Indeed, such exemplary embodiments may also have practical value in positioning cochlear implant electrode arrays in appropriate locations. It should be noted that in at least some exemplary embodiments, spikes or the like are utilized to pierce at least a portion of the wall of a given structure. This can cause trauma and / or initiate a foreign body reaction. Indeed, in exemplary embodiments, a device similar to a splinter can be used that induces a foreign body reaction when piercing the outer wall of tissue.

[0102] Likewise, optical electrodes may be utilized. In some embodiments, heat may be utilized. In this regard, a heating device that applies thermal energy to the tissue structure may be utilized. In some embodiments, cold may be utilized. In this regard, a device that extracts thermal energy from the tissue structure may be utilized. In at least some other embodiments, any device, system, and / or method that can induce trauma and / or a foreign body reaction or otherwise induce irritation to manage BLB may be utilized.

[0103] In an exemplary embodiment, the stimulus utilized may be one that inflames the blood labyrinth barrier.

[0104] Consistent with the teachings detailed above, stimuli can be applied to structures of the middle ear meatus and cochlea. In an exemplary embodiment, administering a therapeutic substance to a person is performed by administering the substance at a location remote from the structure. That is, in an exemplary embodiment, administering the therapeutic substance to a person is performed by administering the substance at or near the structure.

[0105] It should be noted that in many cases, the embodiments described in detail above focus on the use of prostheses that provide trauma / trigger a foreign body reaction or otherwise cause irritation. In exemplary embodiments, manual devices / non-prosthetic devices can be used. For example, a handheld needle that is used to cause trauma. In exemplary embodiments, a range of similar substances can be used to apply chemical irritants, also manually. In exemplary embodiments, the irritant can be delivered to the round window and / or oval window by the surgeon during surgery. Of course, this can also be done or alternatively by the prosthesis after implantation. This can cause a slightly irritated BLB, thereby causing a slightly or even more than slightly opened BLB. After this, therapeutic substances can be delivered in a systemic manner. These can be provided orally, intravenously, or locally during surgery, or can be delivered via a device implanted in the recipient. This can result in achieving higher concentrations and / or higher amounts of therapeutic substances at local locations. This can be performed as a one-time delivery, which can be done in a one-time dose fashion to stimulate the BLB over time, or it can be done in a more systematic fashion to maintain increasing concentrations and higher amounts of the substance relative to what would be the case in the absence of the teachings detailed herein.

[0106] It should also be noted that at least some of the exemplary embodiments detailed above have focused on implantable devices. Thus, in exemplary embodiments, there is a system that includes an implantable blood-labyrinth barrier management component configured to influence the blood-labyrinth barrier to control the amount of a substance in the anatomical structure beyond what would be the case in the absence of the influence. In the exemplary embodiments detailed above, such a system may be Figure 7In at least some exemplary embodiments, any arrangement that can affect the BLB can be utilized. The system need not be associated therewith with an implantable sensory prosthesis. That is, in alternative embodiments, consistent with the teachings detailed above, the system can include an implanted sensory prosthesis. Such embodiments can correspond to, for example, Figure 3A or Figure 8 or Figure 9 Consistent with these embodiments, in exemplary embodiments, there is an implantable sensory prosthesis component as part of a system, wherein the blood labyrinth barrier management component is integrated with the sensory prosthesis component. Conversely, in some embodiments, the blood labyrinth barrier management component can be utilized separately and can be a separate component from the sensory prosthesis. For example, Figure 7 The embodiment can be used with Figure 1A The RF inductor coils implanted in the receiver can be implanted adjacent to each other so that these components can be utilized separately. That is, using two separate external components, these components can be utilized simultaneously.

[0107] It should also be noted that although some of the embodiments detailed above have been directed to devices that combine BLB management components with sensory prostheses, in some embodiments, the BLB management component can instead or can also be part of an implantable drug delivery component, wherein the drug delivery component is configured to deliver substances to anatomical structures. In fact, in exemplary embodiments, the implantable component is configured to measure or otherwise assess the concentration and / or amount of a drug or some other substance or other phenomena related thereto at a local location, and effectively open and / or close the BLB to achieve the desired concentration and / or amount of the substance, or otherwise change or otherwise affect the amount and / or concentration of the therapeutic substance. In exemplary embodiments, there may be method actions including loop delivery, such as a scheme including deliver / open / deliver / open / deliver / open / deliver / open, etc., to achieve the therapeutic purpose. In some cases, the loop can be performed in a manner that precisely modulates the inner ear drug concentration by increasing and / or decreasing the concentration according to practicality. In fact, in exemplary embodiments, the loop can include deliver / open / deliver / open / close / deliver / open / open more / close / deliver / open, etc. In this regard, the opening and / or closing actions can be performed repeatedly as practical to achieve a level of precision that is greater than that achieved by performing one or more methods only once. In an exemplary embodiment, a cochlear implant can be used to potentially regulate therapeutic substances in or near the cochlea in a closed-loop feedback loop. In an exemplary embodiment, a cochlear implant can be used to potentially regulate harmful substances in or near the cochlea in a closed-loop feedback loop.

[0108] In this regard, in an exemplary embodiment, as in Figure 15 As seen in FIG, there can be a sensor 335 that is part of the sensory prosthesis (or part of a drug delivery system, or part of a trauma-inducing and / or foreign body response-inducing device, etc.) positioned so that when the prosthesis is implanted in a recipient, the sensor 335 can be located at a location where the concentration and / or amount of the substance in question can be or otherwise desired to be monitored or otherwise regulated or managed. In this regard, in an exemplary embodiment, the sensor 335 is a chemical sensor and / or a mass sensor and / or a particulate sensor that is in wired or wireless communication with another component of the prosthesis and can be integrated with or otherwise in signal communication with a controller or the like, such as a processor programmed to perform one or more of the teachings detailed herein, which can be programmed to analyze the signal from the sensor 335 and assess the amount and / or concentration of the substance in question. Based on this assessment, the prosthesis can be controlled to manage the BLB in accordance with the teachings detailed herein to adjust or maintain the BLB in a manner such that the desired amount and / or concentration of the substance in question is achieved or otherwise maintained or otherwise pushed toward the desired amount.

[0109] As with some of the embodiments described in detail above, in exemplary embodiments, the blood labyrinth barrier management component may be configured to deliver an inflammatory substance to or near an anatomical structure.

[0110] In exemplary embodiments, the blood-labyrinth barrier management component is configured to at least passively manage the blood-labyrinth barrier, while in other embodiments, the blood-labyrinth barrier management component is configured to at least actively manage the barrier. It should be noted that the two are not exclusive, and in some embodiments, the management component can manage the BLB both actively and passively.

[0111] In exemplary embodiments, any disclosure herein regarding a foreign body reaction also corresponds to disclosure of encapsulation after the foreign body reaction. In some embodiments, this can allow inflammation to be encouraged for a period of time and then allow normal healing.

[0112] In view of the above, it can be seen that in at least some exemplary embodiments, there is a device and system and method that implements and the method causes or otherwise includes the management of BLB using an inflammatory compound or inflammatory structure or inflammatory action. In exemplary embodiments, the inflammatory compound is delivered to the middle ear and / or is positioned at the round window and / or oval window. In exemplary embodiments, the methods detailed herein may include the use of an inflammatory compound delivered from a cochlear implant and / or from a drug pump and / or from a middle ear implant / direct acoustic cochlear stimulator. In some exemplary embodiments, an implant can be placed into a recipient that has its primary purpose, and in at least some exemplary embodiments, its purpose is solely to act as an implant that induces a foreign body reaction and / or causes trauma and / or causes the irritation described above, which can manage the BLB - such as by opening the BLB and / or closing the BLB. The induction of the foreign body reaction, etc. can be accomplished by active arrangement and / or by passive arrangement.

[0113] To be clear, the inflammatory compound and / or irritant action and / or trauma-inducing action and / or foreign body-inducing action can be performed using a prosthesis and / or can be performed manually. Indeed, in exemplary embodiments, a surgeon can implant a fragment, etc., into the cochlea or the annulus wall, etc., which can induce a foreign body reaction. In some embodiments, electrical stimulation can be applied through the skin. In this regard, electrodes can be placed in the recipient's ear canal during the examination procedure.

[0114] Likewise, in at least some embodiments, any device, system, and / or method that enables BLB to be managed can be utilized. For example, this may require utilizing noise (audible noise), utilizing ultrasound, utilizing infrasound, and / or utilizing pressure, and / or utilizing heat and / or cold. In some embodiments, any type of stimulation that enables BLB to be managed can be utilized. In fact, in some embodiments, this can be accomplished if stimulation at a location remote from, for example, the cochlea can be utilized to manage BLB.

[0115] It should be noted that, in at least some exemplary embodiments, any one or more actions described herein that are not associated with inducing auditory perception are performed in a manner that is not audible to the recipient. In this regard, in exemplary embodiments, at least some of the actions described herein are performed without inducing auditory perception.

[0116] To be clear, in at least some exemplary embodiments, it is possible to manage the barrier between blood vessels and neural tissue and / or the functional structure and / or tissue of the organ in question, such as by controlling inflammatory response. In at least some exemplary embodiments, the teachings described in detail herein can be utilized to protect or otherwise reduce the possibility that nerves that are very sensitive to chemotherapy or any other phenomenon may be damaged, or otherwise reduce the damage caused there due to the occurrence of a given phenomenon via the management of BLB. In certain embodiments, the teachings described in detail herein are utilized to limit the entry of toxins and / or limit the entry of immune cells. In an exemplary embodiment, the teachings described in detail herein are utilized to increase the entry of therapeutic substances such as steroids delivered intravenously. In an exemplary embodiment, relative to the situation where the teachings described in detail herein are not present, the management of BLB can be utilized to better carry out comprehensive treatment with therapeutic substances.

[0117] The teachings detailed herein can also be utilized in some exemplary embodiments where a drug is delivered during implantation of a sensory prosthesis. In at least some scenarios, at least without the teachings detailed herein, drug concentrations decrease after implantation. The teachings detailed herein can be utilized to prevent or at least limit this decrease.

[0118] The various teachings above relate to systemic delivery of substances. The various teachings above relate to local delivery of substances (e.g., into the cochlea or to the cochlear wall or to the round or oval window, etc.). In at least some exemplary embodiments, the substance is a therapeutic substance, such as a drug. In at least some exemplary embodiments, the delivered substance can be a steroid.

[0119] The teachings detailed herein can be utilized to manage the concentration and / or amount of substances delivered systemically and / or locally. The teachings herein can also be utilized to manage the concentration and / or amount of substances delivered systemically and locally. In this regard, in exemplary embodiments, substances can be delivered locally simultaneously in a manner closer to the relative time of substances delivered systemically. In exemplary embodiments, there is a method that includes balancing or otherwise manipulating or controlling or influencing the substance gradient within the structure of the recipient and the substance gradient outside the structure of the recipient. In this regard, in exemplary embodiments, the low substance concentration in the structure is combined with the management of the BLB (such as by opening the BLB or otherwise increasing the permeability of the BLB) to cause the substance applied systemically to be absorbed into the structure. This may be because, in some exemplary embodiments, the concentration in the structure is low while the whole body and / or blood concentration is high. On the contrary, in exemplary embodiments, the high substance concentration in the structure and the open BLB can cause the substance applied locally to be dissipated. For example, this may be because of the concentration gradient between the structure and the rest of the body. Thus, given the above examples, it can be seen that in at least some exemplary cases, systemic treatment is superior to local treatment, which may seem counterintuitive. It is possible that in at least some exemplary scenarios, this counterintuitive result is due to the BLB being open. At least some exemplary embodiments include managing or otherwise controlling or otherwise balancing the amount of substance delivered systemically versus the amount of substance delivered locally to achieve or otherwise manage a desired concentration and / or amount within the structure.

[0120] Given the above, in exemplary embodiments related to the cochlea, there may be a scenario where, all else being equal, systemic delivery of steroids is superior to the results achieved with local steroid administration. In exemplary embodiments, this may be because the perilymph fluid in the cochlea has no or minimal drug concentration, but the blood-labyrinth barrier is open. This can result in a concentration gradient that can draw the steroid into the cochlea, and therefore into the perilymph fluid, thereby increasing the concentration and / or amount thereof relative to alternative local administration. It should be noted that, in at least some exemplary embodiments, these amounts are based on a time period of days, weeks, or months. In exemplary embodiments, the above differences or values ​​or amounts are 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, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 225, 250, 275, 380, 390, 400, 410, 420, 430, 440, 450, 460, 470, 480, 490, 500, 510, 520, 530, 540, 550, 560, 570, 580, 590, 600 , 500, 550, 600, 650, 700, 750, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, 2500, 3000, 3500, 4000, 4500, 5000, 5500, 6000, 7000, 8000, 9000, or 10,000 hours or days. It should also be noted that the differences, values, or quantities can be measured and / or averaged after a set time period has elapsed. By way of example only and not limitation, in exemplary embodiments, it is always the case that the concentration / amount of a locally administered drug is higher in the local area than with systemic administration. However, this phenomenon only occurs for a period of time. Thus, in an exemplary embodiment, the balance will be reduced, and evaluation can begin after that period of dominant performance. In this regard, it can be assumed that for the first two, three, or four days, or hours, or weeks, the topically applied drug will be dominant. After that period of dominant performance, management can begin. That is, in alternative embodiments, the dominant period can be taken into account and used as part of a treatment regimen. It should be noted that in some embodiments, the teachings detailed herein are not steroid-dependent. In some cases, some, most, or all drugs can produce side effects. This method / approach can allow for reduced systemic concentrations of the drug.

[0121] The above corollary is that a locally administered drug may result in a high concentration of the drug in the perilymph, and if there is a high gradient relative to the amount of material outside the cochlea when the BLB is open, the drug may be rapidly lost from the cochlea. In this regard, it should be noted that the period until the drug is lost from the cochlea can be an advantage.

[0122] In view of the foregoing, exemplary embodiments may include customizing systemic and local doses of a substance to achieve a desired amount and / or concentration, or otherwise driving concentration and amount toward a desired amount and / or concentration. By way of example only and not limitation, for exemplary drugs, in some instances, it is practical not to apply any drug locally but instead to apply the drug entirely systemically. Further, for exemplary drugs, in some instances, it is practical to apply the drug only locally rather than systemically. Further, for example, it is practical to apply the drug locally and systemically using various different doses for these two situations so that, in combination with opening and / or closing or partially closing the BLB, the concentration within and outside the structure (such as within and outside the cochlea) is managed so that the concentration and / or amount can be controlled. (Although the embodiments herein have been directed to the cochlea, it should be noted that the teachings detailed herein can also be applied to the organs of hearing and balance, to the extent they share common features applicable to the teachings detailed herein. It should also be noted that the teachings detailed herein can also be applied to the eye. Thus, any disclosure herein relating to methods of treating or otherwise relating to and / or devices for treating an organ corresponds to the disclosure herein of treating any of the aforementioned organs, including the eye, to the extent that one is skilled in the art and that the particular teachings can be modified to accomplish this.)

[0123] In an exemplary embodiment, the amount applied at the local location can range from zero to the highest possible amount or at least the highest amount no matter what happens, with any additional amount being wasted or otherwise useless, while the amount applied systemically can range from the highest possible amount or at least the highest amount no matter what happens to zero, with any additional amount being wasted or potentially dangerous. By balancing these two amounts, a practical treatment can be developed. The following table provides exemplary conceptual unit amounts. In exemplary embodiments, in some embodiments, such as for a given BLB condition, applying a local amount in combination with a systemic amount can produce practical results.

[0124]

[0125]

[0126] Unit Part Unit whole body 0 100 5 90 10 80 15 50 20 30 25 10 30 0

[0127] Unit Part Unit whole body 0 100 2.5 95 5 90 7.5 85 9 80 11 75 13 70

[0128] It should be noted that the above table is exemplary only and is provided for conceptual purposes. Depending on the desired concentration and / or amount (related to the condition of the BLB), a given amount of drug will be applied locally and systemically.

[0129] It should be noted that different doses can be applied for different BLB conditions. By way of example only and not limitation, in embodiments where the BLB is open and therefore porous, it may be practical to provide a higher systemic dose than a local dose relative to what the specific dose would be, whereas in embodiments where the BLB is closed, it may be practical to provide a lower systemic dose than a local dose relative to what the specific dose would be. The point is that in exemplary embodiments, by managing or otherwise utilizing specific doses at local and systemic sites, either alone or in combination with managing or otherwise assessing the state of the BLB, concentrations and / or amounts can be managed in a more practical manner than would be the case without practicing these teachings.

[0130] Exemplary embodiments may include a method wherein the BLB is held or otherwise driven closed while a drug is administered locally and then opened after a period of time that is empirically or otherwise estimated or calculated that the level of the therapeutic substance in the structure will decrease, and then a large amount of systemically administered drug is provided, and the gradient between the structure and the rest of the body causes the drug to be drawn into the structure. In exemplary embodiments, there is a method that forces the BLB to remain closed and / or open 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, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, or 48 hours, days, or weeks. In exemplary embodiments, the closing and / or opening is achieved, for example, via the use of drugs and / or biotherapeutic substances and / or other stimulation protocols as described in detail herein. It should be noted that the aforementioned closing and / or opening can correspond to 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, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100 , 48, 49, 50, 60, 70, 80, 90, 100, 125, 150, 175, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1250, 1500, 1750, 2000, 2500, 3000, 3500, 4000, 4500 or 5000 more (in the case of opening) or less (of course limited to 100%) (in the case of closing) closing and / or opening. Any device, system and / or method developed now or later that can fully or partially open and / or close the BLB so that this can be practical can be utilized in exemplary embodiments.

[0131] In view of the above, it can be seen that, in an exemplary embodiment, there is a method comprising the acts of administering a therapeutic substance to a human and managing the concentration and / or amount of the substance in the human's cochlea by taking into account the human's blood-labyrinth barrier. In an exemplary embodiment, managing the concentration and / or amount is performed by altering the blood-labyrinth barrier. This can be accomplished by opening and / or closing the barrier in any of the manners detailed herein and / or in any other manner that may be of practical value.

[0132] In some embodiments, a therapeutic substance is administered both locally and systemically, and management of the concentration and / or amount of the substance is performed by balancing the local amount and the systemic amount. In some embodiments, the amount of the substance administered locally and / or the amount of the substance administered systemically is determined based on the state of the blood-labyrinth barrier (e.g., open, closed, etc.). Similarly, this can be done to adjust / obtain a concentration gradient of the substance between the interior and exterior of the cochlea, thereby managing the amount and / or concentration. In some embodiments, the amount of the substance administered locally and the amount of the substance administered systemically are determined to maintain or obtain a concentration and / or amount of the substance in the cochlea (or at a specific region or region(s) of the cochlea, such as, for example, at a location corresponding to a specific frequency location in the cochlea), wherein the amount provided locally is less than the maximum amount that can be effectively applied (i.e., the excess amount would be wasted). In some embodiments, the amount of substance provided systemically is less than the maximum amount that can be effectively applied (i.e., the excess amount would be wasted). In some embodiments, the amount of substance provided systemically is less than the maximum amount that can be effectively applied (i.e., the excess amount would be wasted). In some embodiments, the amount of substance provided systemically is less than the maximum amount that can be effectively applied (i.e., the excess amount would be wasted). In some embodiments, the amount of substance provided systemically is less than the maximum amount that can be effectively applied (i.e., the excess amount would be wasted). In some embodiments, the amount of substance provided systemically is less than the maximum amount that can be effectively applied (i.e., the excess amount would be wasted).

[0133] About systemic administration, due to injection of lipopolysaccharide (LPS), there may be damaged BLB. Exemplary embodiments include systemic administration, which includes inflammatory components (such as LPS) and treatments that all target the inner ear. Such exemplary embodiments also include controlling or otherwise alleviating the systemic damage caused by performing such an operation. In an exemplary embodiment, the method can include systemic delivery of safe molecules until they reach the ear or other targeted organs, and then releasing the inflammatory payload (LPS or other). Therefore, the embodiment also includes those molecules.

[0134] In an exemplary embodiment, there is an action that modifies the permeability of the round and / or oval windows, such as some type of shock, and then delivers a drug to the area. In an exemplary embodiment, an electric current is applied to the round and / or oval windows. In an exemplary embodiment, a mechanical stimulation is applied to the window(s), such as with a needle or scraping device. In an exemplary embodiment, a chemical compound is applied to the permeability of the window.

[0135] Consistent with the embodiments detailed above, in exemplary embodiments, current is utilized to achieve at least some of the teachings detailed herein, such as to achieve the trauma described above or otherwise induce a foreign body reaction, using a cochlear implant electrode array such that the Shannon limit is temporarily exceeded. This is a safe charge density for platinum electrodes (and in exemplary embodiments, the electrodes utilized to provide current are platinum electrodes). In exemplary embodiments, this temporary exceeding of the Shannon limit can cause trauma and / or open the BLB.

[0136] It should be noted that the aforementioned Shannon Limit can be linked to electrode size and / or charge injection level. Therefore, in an exemplary embodiment, there is a method for estimating the current required to exceed the Shannon Limit and / or the voltage required to exceed the Shannon Limit by a certain percentage, by considering the electrode size and / or electrode composition and / or the exposed area of ​​the electrode (e.g., the portion not covered by silicone or other types of materials) and controlling a conventional cochlear implant to exceed the Shannon Limit by the aforementioned percentage. In an exemplary embodiment, the standard stimulation time and / or average value (mean, median or mode) of a given electrode used to induce auditory perception using a cochlear implant for a given recipient is greater than or equal to 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 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, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65 9, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 60, 70, 80, 90, 100, 125, 150, 175, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1250, 1500, 1750, 2000, 2500, 3000, 3500, 4000, 4500 or 5000 or more percent than (or any value or range of values ​​therebetween in increments of 0.01), the Shannon limit is exceeded by 1, 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, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 60, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105 0, 90, 100, 125, 150, 175, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1250, 1500, 1750, 2000, 2500, 3000, 3500, 4000, 4500 or 5000 or more (whatever is used to calculate the Shannon limit results in an increase) (for example, the applied charge is 10 times the Shannon limit and the time for which the charge is applied is twice the standard pulse length, where the standard pulse is 400 microseconds).

[0137] It should be noted that in at least some embodiments, it is the increased charge rather than the dissolved platinum that triggers the reaction, or at least the primary driving factor is the former rather than the latter. In this regard, it should be noted that in some embodiments, the two are linked. The direct impact of high current offset may damage cells (as well as some heat, protein denaturation and / or possible generation of bubbles). If achieved within a reasonable time period, platinum will also accumulate in the tissue, and according to the teachings detailed herein, platinum may also cause trauma and / or open BLB.

[0138] In view of the above, there is an exemplary method that includes the following actions: modifying the blood labyrinth barrier by systemically delivering an inflammatory substance, such as LPS, to thereby manage the concentration and / or amount of a therapeutic substance in an organ. In the exemplary embodiment, the actions of managing the concentration and / or amount (e.g., without the specific molecule detailed above) are performed by systemically delivering an inflammatory substance (e.g., LPS) (in a first state, which, if delivered systemically in an amount that opens the blood labyrinth barrier, would have a deleterious effect on the recipient's tissues). In this embodiment, the inflammatory substance is systemically delivered in a second state different from the first state (in an amount that would be harmful if in the first state), wherein the second state is a state that has less harmful effects on the recipient's tissues relative to the first state (e.g., more than 1, 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 , 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 60, 70, 75, 80, 85, 90, 91, 92, 93, 94, 95, 96, 97, 97, 98 or 99% or equal to 100% harmless) and the method further includes: when the substance is close to the cochlea (or other target organ), converting the inflammatory substance from the second state to the first state, thereby managing the concentration and / or amount of the substance in the cochlea (or other target organ). In exemplary embodiments, this can be accomplished via a timed release system and / or via application of a stimulus, such as, for example, application of electrical energy and / or application of another substance that temporarily alters the recipient's body chemistry (e.g., increases salinity), which triggers the conversion from the second state to the first state, and / or via application of a stimulus to the recipient's state, such as increasing and / or decreasing the recipient's blood pressure and / or causing the recipient's temperature to increase or decrease.

[0139] In an exemplary embodiment, the act of managing concentration and / or amount is performed by applying electrical stimulation from a cochlear implant electrode array positioned in the cochlea of ​​the recipient such that platinum from electrodes comprising the electrode array diffuses from / is released from the cochlea in an amount that exceeds that which occurs during normal operation of the electrode array.

[0140] In an exemplary embodiment, the increase in platinum diffusion is 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 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, 36 percent higher than normal , 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 60, 70, 80, 90, 100, 125, 150, 175, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1250, 1500, 1750, 2000, 2500, 3000, 3500, 4000, 4500 or 5000 or more.

[0141] It should also be noted that any disclosure herein of a device and / or system detailed herein also corresponds to disclosures providing such device and / or system in other ways. Any disclosure herein of a method action corresponds to a device and / or system configured to perform such method action. Any disclosure herein of a device and / or system having functionality corresponds to a method for performing the action corresponding to that functionality. Any disclosure of a method for manufacturing a device and / or system corresponds to the resulting device and / or system, and vice versa. It should also be noted that, unless otherwise indicated, any element of any embodiment detailed herein may be combined with any other element of any embodiment detailed herein, as far as is within the skill of the art. It should also be noted that, in at least some exemplary embodiments, any one or more elements of an embodiment detailed herein may be explicitly excluded from the exemplary embodiment. That is, in at least some exemplary embodiments, there are embodiments that explicitly do not have one or more elements detailed herein. 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 those skilled in the relevant art that various changes in form and detail may be made without departing from the spirit and scope of the present invention.

Claims

1. A system comprising: A medical device component is configured to manage a blood labyrinth barrier of a human body to influence the blood labyrinth barrier to control an amount of a substance in an anatomical structure that exceeds the amount of the substance in the absence of the influence.

2. The system according to claim 1, further comprising: An implantable sensory prosthesis component, the medical device component being integrated with the sensory prosthesis component.

3. The system of claim 1 , wherein: The medical device component is configured to deliver an inflammatory substance to or proximate to the anatomical structure.

4. The system of claim 1 , wherein: The medical device component is part of an implantable drug delivery component, wherein the drug delivery component is configured to deliver the substance to the anatomical structure.

5. The system of claim 1 , wherein: The medical device component passively manages the blood-labyrinth barrier.

6. The system of claim 1 , wherein: The medical device component actively manages the blood labyrinth barrier.

7. The system of claim 1 , wherein: The medical device component is configured to induce a foreign body response and is subsequently packaged to manage the blood-labyrinth barrier.

8. The system of claim 1 , wherein: The medical device component is configured to be located entirely outside of the cochlea of ​​the human body.

9. The system of claim 8, wherein: The blood-labyrinth barrier is located between the human cochlear tissue and blood vessels.

10. The system of claim 1, wherein: The medical device component is a device for managing the blood labyrinth barrier of the human body.

11. A system comprising: An implantable blood labyrinth barrier management component is configured to influence the blood labyrinth barrier to control an amount of a substance in an anatomical structure that exceeds the amount of the substance in the absence of the influence.

12. The system of claim 11, further comprising: An implantable sensory prosthesis component wherein the blood labyrinth barrier management component is integrated with the sensory prosthesis component.

13. The system of claim 11, wherein: The blood labyrinth barrier management component is configured to deliver an inflammatory substance to or proximate to the anatomical structure.

14. The system of claim 11, wherein: The blood labyrinth barrier management component is part of an implantable drug delivery component, wherein the drug delivery component is configured to deliver the substance to the anatomical structure.

15. The system of claim 11, wherein: The blood labyrinth barrier management component passively manages the blood labyrinth barrier.

16. The system of claim 11, wherein: The blood labyrinth barrier management component actively manages the blood labyrinth barrier.

17. The system of claim 11, wherein: The blood labyrinth barrier management component is configured to induce a foreign body response and then be packaged to manage the blood labyrinth barrier.

18. A system comprising: An implantable blood labyrinth barrier management component is configured to influence the permeability of the blood labyrinth barrier to control the amount of therapeutic substance in the anatomical structure to exceed the amount of therapeutic substance in the absence of said influence, wherein the implantable blood labyrinth barrier management component actively manages the permeability of the blood labyrinth barrier by inducing a trauma / foreign body response using a mechanical stimulation / mechanical force output device or an electrical stimulation / electrical output device.

19. The system of claim 18, further comprising: An implantable sensory prosthesis component wherein the implantable blood labyrinth barrier management component is integrated with the sensory prosthesis component.

20. The system of claim 18, wherein: The implantable blood-labyrinth barrier management component is configured to deliver an inflammatory substance to or proximate to the anatomical structure.

21. The system of claim 18, wherein: The implantable blood-labyrinth barrier management component is part of an implantable drug delivery component, wherein the drug delivery component is configured to deliver the therapeutic substance to the anatomical structure.

22. The system of claim 18, wherein: The therapeutic blood labyrinth barrier management component is configured to increase and / or decrease the permeability of the blood labyrinth barrier.

23. The system of claim 18, wherein: The implantable blood-labyrinth barrier management component is configured to induce a trauma and / or foreign body response in the inner ear and / or middle ear of a recipient.

24. The system of claim 23, wherein: The implantable blood-labyrinth barrier management component is configured to extend into the cochlea of ​​a recipient and electrically stimulate tissue within the recipient to induce the trauma.

25. The system of claim 23, wherein: The implantable blood-labyrinth barrier management component is a cochlear electrode array, which is configured to extend into the recipient's cochlea and electrically stimulate tissue of the cochlea in various ways to induce auditory perception, and is configured to electrically stimulate tissue in the recipient's body to cause the trauma.

26. The system of claim 23, wherein: The implantable blood-labyrinth barrier management component is a cochlear implant configured to extend into the cochlea of ​​a recipient and electrically stimulate tissue of the cochlea in various ways to induce auditory perception, and configured to electrically stimulate tissue within the recipient to cause the trauma without inducing auditory perception.

27. The system of claim 23, wherein: The implantable blood-labyrinth barrier management component includes a drug delivery device.

28. The system of claim 23, wherein: The implantable blood-labyrinth barrier management component is configured to detect a physical phenomenon within the cochlea and to cause the trauma upon detecting the physical phenomenon.

29. The system of claim 23, wherein: The implantable blood-labyrinth barrier management component is configured to detect a physical phenomenon within the cochlea by monitoring at a location external to the cochlea, and then open tight junctions of cells at the round window upon detecting the physical phenomenon.

30. The system of claim 23, wherein: The implantable blood-labyrinth barrier management component is configured to detect a physical phenomenon within the cochlea by monitoring at the round window niche of the recipient, and then to open tight junctions of cells at the round window upon detecting the physical phenomenon.

31. The system of claim 23, wherein: The implantable blood-labyrinth barrier management component is configured to modify the permeability of the round window and / or the oval window by applying an electrical current and then deliver a drug to the area.

32. The system of claim 23, wherein: The implantable blood-labyrinth barrier management component includes a pressure-based assembly configured to expand upon pressurization of a component thereof.

33. A system comprising: An implantable blood labyrinth barrier management component is configured to influence a blood labyrinth barrier to control an amount of a substance in an anatomical structure beyond that which would be present in the absence of the influence.

34. The system of claim 33, further comprising: An implantable sensory prosthesis component wherein the blood labyrinth barrier management component is integrated with the sensory prosthesis component.

35. The system of claim 33, wherein: The blood labyrinth barrier management component is configured to deliver an inflammatory substance to or proximate to the anatomical structure.

36. The system of claim 33, wherein: The blood labyrinth barrier management component is part of an implantable drug delivery component, wherein the drug delivery component is configured to deliver the substance to the anatomical structure.

37. The system of claim 33, wherein: The blood labyrinth barrier management component passively manages the blood labyrinth barrier.

38. The system of claim 33, wherein: The blood labyrinth barrier management component actively manages the blood labyrinth barrier.

39. The system of claim 33, wherein: The blood labyrinth barrier management component is configured to induce a foreign body response and is subsequently packaged to manage the blood labyrinth barrier.

40. A method comprising: monitoring physical phenomena within the recipient's cochlea; as well as managing the recipient's blood labyrinth barrier based on the monitored physical phenomenon, wherein: Managing the blood-labyrinth barrier is performed by applying electrical stimulation from a cochlear implant electrode array located in the cochlea of ​​the recipient.

41. The method of claim 40, wherein: The act of managing the blood labyrinth barrier includes inducing a change in the recipient's blood labyrinth barrier based on the monitored physical phenomenon.

42. The method of claim 41 , wherein: The alteration of the blood labyrinth barrier is an increase in the permeability of the blood labyrinth barrier; and Due to the increase in permeability, the amount and / or concentration of a substance in the cochlea is reduced relative to a situation in the absence of the increase in permeability.

43. The method of claim 42, wherein: The substance is a drug that is introduced into the recipient's body at a location remote from the cochlea and is a drug not related to hearing disease.

44. The method of claim 42, wherein: The substance is a drug that is introduced into the body of the recipient at a location within and / or near the cochlea.

45. The method of claim 41 , wherein: The alteration of the blood labyrinth barrier is an increase in its permeability; and Due to the increase in permeability, the amount and / or concentration of a substance in the cochlea increases relative to a situation in the absence of the increase in permeability.

46. ​​The method of claim 45, wherein: The substance is a drug that is introduced into the recipient's body at a location remote from the cochlea and is a drug related to treatment of the recipient's auditory system.

47. The method of claim 41 , wherein: The act of inducing changes in the recipient's blood-labyrinth barrier has also been performed via the infusion of inflammatory compounds into the scala tympani of the cochlea.

48. The method of claim 40, wherein: The physical phenomena are those associated with ototoxicity.

49. The method of claim 40, wherein: The act of managing the blood-labyrinth barrier comprises intentionally changing the blood-labyrinth barrier, wherein the act of changing the blood-labyrinth barrier controllably increases and / or decreases the rate of transfer of a therapeutic substance from the inside of the cochlea to the outside of the cochlea, and thereby changes the concentration and / or amount of the therapeutic substance within the cochlea.

50. A method comprising: administering therapeutic substances to humans; as well as causing a wound in or near an anatomical structure of the person, thereby adjusting the concentration and / or amount of the therapeutic substance in the anatomical structure relative to a situation in the absence of the wound, wherein The trauma is performed by applying electrical stimulation from electrodes located within the person.

51. The method of claim 50, wherein: The modification is a reduction in the amount and / or concentration of the therapeutic substance in the anatomical structure relative to a situation in the absence of the trauma.

52. The method of claim 50, wherein: The modification is an increase in the amount and / or concentration of the therapeutic substance in the anatomical structure relative to a situation in the absence of the trauma.

53. The method of claim 50, wherein: The anatomical structure is the cochlea.

54. The method of claim 50, wherein: The anatomical structure is one of a kidney or an eye.

55. The method of claim 50, wherein: The anatomical structure is the cochlea; The human is a recipient of a cochlear implant comprising an electrode array inserted into the cochlea, the electrode array comprising the electrodes.

56. The method of claim 55, further comprising: automatically providing, via the cochlear implant and / or a support device for the cochlear implant, at least one of a reminder or a query to the person, the reminder or the query, respectively, directing the person to perform an action to administer the therapeutic substance to the person; receiving feedback from the person in response to the automatic providing, the feedback indicating that the person has administered the therapeutic substance to himself / herself and has thereby performed an action of administering a therapeutic substance to the person; as well as Based on the received feedback, the trauma is inflicted using the cochlear implant.

57. The method of claim 50, wherein: The act of causing trauma is also performed by applying a stimulus to said structure of said person.

58. The method of claim 57, wherein: The stimulant is at least one of a chemical-based stimulant or a mechanical-based stimulant.

59. The method of claim 57, wherein: The stimulus is applied to structures of the cochlea and / or middle ear; and The act of administering the therapeutic substance to the person is performed by administering the substance at a location remote from the structure.

60. The method of claim 50, wherein: The anatomical structure is the cochlea; The human is a recipient of a cochlear implant comprising an electrode array inserted into the cochlea; and The cochlear implant causes trauma by exceeding the Shannon limit of the electrodes of the electrode array.

61. A method comprising: administering therapeutic substances to humans; as well as The concentration and / or amount of the substance in the cochlea of ​​the human is managed by taking into account the blood-labyrinth barrier of the human, wherein The act of managing the concentration and / or amount is performed by applying electrical stimulation from a cochlear implant electrode array located in the cochlea of ​​the recipient.

62. The method of claim 61 , wherein: The act of managing the concentration and / or amount is performed by altering the blood labyrinth barrier.

63. The method of claim 61 , wherein: The therapeutic substance is administered locally and systemically; and Management of the concentration and / or amount of the substance is performed by balancing the local amount and the systemic amount.

64. The method of claim 61, wherein: The therapeutic substance is administered locally and systemically; and The amount of substance administered locally and the amount of substance administered systemically are determined based on the state of the blood labyrinth barrier.

65. The method of claim 61 , wherein: The therapeutic substance is administered locally and systemically; and The amount of substance administered locally and the amount of substance administered systemically are determined to obtain a concentration gradient of the substance between the inside of the cochlea and the outside of the cochlea, thereby managing the amount and / or concentration.

66. The method of claim 61 , wherein: The therapeutic substance is administered locally and systemically; and The amount of substance administered locally and the amount of substance administered systemically are determined to maintain the concentration and / or amount of substance in the cochlea, wherein the amount provided locally is less than the maximum amount that can be effectively applied.

67. The method of claim 61 , wherein: The act of managing the concentration and / or amount is further performed by applying the electrical stimulation from the cochlear implant electrode array positioned in the cochlea of ​​the recipient such that an amount of platinum comprising electrodes of the electrode array diffuses therefrom in excess of an amount that occurs during normal operation of the electrode array to induce auditory perception.

68. The method of claim 61 , wherein: The act of managing the concentration and / or amount is further performed by applying the electrical stimulation from the cochlear implant electrode array positioned in the cochlea of ​​the recipient such that the Shannon limit is intentionally exceeded.

69. The method of claim 61, wherein: The act of managing the concentration and / or amount is also performed by systemically delivering inflammatory substances to alter the blood labyrinth barrier.

70. The method of claim 61 , wherein: Managing the concentration and / or amount is further performed by systemically delivering an inflammatory substance to alter the blood labyrinth barrier, the inflammatory substance in a first state having a deleterious effect on tissues of the recipient if delivered systemically in an amount that opens the blood labyrinth barrier; The inflammatory substance is systemically delivered in a second state different from the first state, wherein the second state is a state that has less deleterious effects on tissues of the recipient relative to the deleterious effects of the first state; and The method further includes transitioning the inflammatory substance from the second state to the first state when the substance is proximate to the cochlea, thereby managing the concentration and / or amount of the substance in the cochlea.

71. A method comprising: monitoring physical phenomena associated with the recipient's organs; and managing the recipient's blood labyrinth barrier based on the monitored physical phenomena.

72. The method of claim 71 , wherein: The act of managing the blood labyrinth barrier includes inducing a change in the recipient's blood labyrinth barrier based on the monitored physical phenomenon.

73. The method of claim 71 , wherein: The physical phenomena are those associated with ototoxicity.

74. The method of claim 72, wherein: The alteration of the blood labyrinth barrier is an increase in its permeability; and Due to said increase in permeability the amount and / or concentration of a substance in said organ is reduced relative to a situation in the absence of said increase in permeability.

75. The method of claim 72, wherein: The alteration of the blood labyrinth barrier is an increase in its permeability; and Due to said increase in permeability, the amount and / or concentration of a substance in said organ is increased relative to a situation in the absence of said increase in permeability, wherein said organ is the cochlea.

76. The method of claim 71 , wherein: The management of the blood labyrinth barrier is at least one of: inducing a decrease in the permeability of the blood labyrinth barrier, preventing an increase in the permeability of the blood labyrinth barrier, or limiting an increase in the permeability of the blood labyrinth barrier relative to the absence of the management; and Due to the administration the amount and / or concentration of the substance in the organ is increased relative to a situation in which no reduction in permeability is present.

77. The method of claim 76, wherein: The substance is a drug that is introduced into the body systemically at a location within the cochlea and / or near the cochlea.

78. The method of claim 72, wherein: The act of inducing an alteration in the recipient's blood-labyrinth barrier is performed via the infusion of an inflammatory compound into the scala tympani of the cochlea.

79. A method comprising: administering therapeutic substances to humans; as well as The concentration and / or amount of the substance in the person's anatomy is managed by taking into account the person's blood labyrinth barrier.

80. The method of claim 79, wherein: The act of managing the concentration and / or amount is performed by altering the blood labyrinth barrier.

81. The method of claim 79, wherein: The therapeutic substance is administered locally and systemically; and The amount of substance administered locally and the amount of substance administered systemically are determined to obtain a concentration gradient of the substance between the interior of the anatomical structure and the exterior of the anatomical structure, thereby managing the amount and / or concentration.

82. The method of claim 79, wherein: The therapeutic substance is administered locally and systemically; and The amount of substance administered locally and the amount of substance administered systemically are determined to maintain the concentration and / or amount of the substance in the anatomical structure, wherein the amount provided locally is less than the maximum amount that can be effectively applied.

83. The method of claim 79, wherein: In the act of managing the blood labyrinth barrier, the blood labyrinth barrier of the recipient is intentionally altered.

84. The method of claim 79, wherein: Managing the concentration and / or amount is performed by applying electrical stimulation from a cochlear implant electrode array located in the recipient's cochlea, the cochlea corresponding to the anatomical structure.

85. The method of claim 79, wherein: Managing the concentration and / or amount is performed by systemically delivering an inflammatory substance to modify the blood labyrinth barrier, the inflammatory substance in a first state having a deleterious effect on tissues of the recipient if delivered systemically in an amount that opens the blood labyrinth barrier; The inflammatory substance is systemically delivered in a second state different from the first state, wherein the second state is a state that has less deleterious effects on tissues of the recipient relative to the deleterious effects of the first state; and The method further includes transitioning the inflammatory substance from the second state to the first state when the substance is proximate to the anatomical structure, thereby managing the concentration and / or amount of the substance in the anatomical structure.

86. The method of claim 79, wherein: The act of managing the concentration and / or amount is performed by applying electrical stimulation from a cochlear implant electrode array positioned in a cochlea of ​​the recipient corresponding to the anatomical structure such that an amount of platinum comprising electrodes of the electrode array diffuses therefrom in excess of an amount that occurs during normal operation of the electrode array to induce auditory perception.

87. The method of claim 79, wherein: The anatomical structure is a kidney.

88. A method comprising: monitoring physical phenomena inside the recipient's cochlea; as well as Based on the monitored physical phenomena, the recipient's blood labyrinth barrier is managed.

89. The method of claim 88, wherein: The act of managing the blood labyrinth barrier includes initiating a change in the recipient's blood labyrinth barrier based on the monitored physical phenomenon.

90. The method of claim 88, wherein: The physical phenomena are those associated with ototoxicity.

91. The method of claim 89, wherein: The alteration of the blood labyrinth barrier is an increase in the permeability of the blood labyrinth barrier; and Due to the increase in permeability, the amount and / or concentration of the substance in the cochlea is reduced relative to a situation in the absence of the increase in permeability.

92. The method of claim 91, wherein: The substance is a drug that is introduced into the recipient's body at a location remote from the cochlea and is not associated with hearing disorders.

93. The method of claim 89, wherein: The alteration of the blood labyrinth barrier is an increase in the permeability of the blood labyrinth barrier; and Due to the increase in permeability, the amount and / or concentration of the substance in the cochlea is increased relative to a situation in which the increase in permeability is not present.

94. The method of claim 93, wherein: The substance is a drug that is introduced into the recipient's body at a location remote from the cochlea and is a drug related to the treatment of the recipient's hearing system.

95. The method of claim 88, wherein: The management of the blood labyrinth barrier is at least one of: limiting an increase in the permeability of the blood labyrinth barrier, inducing a decrease in the permeability of the blood labyrinth barrier, or preventing an increase in the permeability of the blood labyrinth barrier relative to the absence of the management; and As a result of the administration, the amount and / or concentration of the substance in the cochlea is increased relative to a situation in which no reduction in permeability is present.

96. The method of claim 95, wherein: The substance is a drug that is introduced into the body of the system at a location within and / or near the cochlea.

97. The method of claim 89, wherein: The act of initiating alteration of the recipient's blood-labyrinth barrier is performed via the infusion of an inflammatory compound into the scala tympani of the cochlea.

98. A method comprising: administering therapeutic substances to the human body; as well as A wound is created in or near the person's anatomy, thereby adjusting the concentration and / or amount of the therapeutic substance in the anatomy relative to a situation in the absence of the wound.

99. The method of claim 98, wherein: The modulation is a reduction in the amount and / or concentration of the therapeutic substance in the anatomical structure relative to a situation in the absence of the wound.

100. The method of claim 98, wherein: The modulation is an increase in the amount and / or concentration of the therapeutic substance in the anatomical structure relative to a situation in the absence of the wound.

101. The method of claim 98, wherein: The anatomical structure is the cochlea.

102. The method of claim 98, wherein: The anatomical structure is one of a kidney or an eye.

103. The method of claim 98, wherein: The anatomical structure is the cochlea; The human is a recipient of a cochlear implant comprising an electrode array inserted into the cochlea; and The cochlear implant causes the trauma.

104. The method of claim 103, further comprising: automatically providing, via the cochlear implant and / or a support device for the cochlear implant, at least one of a reminder or a query, respectively, to the person, thereby directing the person to perform an action to administer the therapeutic substance to the person; receiving feedback from the person in response to the automatic providing, the feedback indicating that the person has administered the therapeutic substance to himself / herself and has thereby performed an action of administering the therapeutic substance to the person; and Based on the feedback received, the trauma is inflicted using the cochlear implant.

105. The method of claim 98, wherein: The act of causing trauma is performed by applying a stimulus to a structure of the person.

106. The method of claim 105, wherein: The stimulation is at least one of a chemical-based stimulation or a mechanical-based stimulation.

107. The method of claim 105, wherein: The stimulation is applied to structures of the middle ear and / or cochlea; and The act of administering the therapeutic substance to the person is performed by administering the substance at a location remote from the structure.

108. The method of claim 98, wherein: The anatomical structure is the cochlea; The human is a recipient of a cochlear implant comprising an electrode array inserted into the cochlea; and The cochlear implant causes the trauma by exceeding the Shannon limit of the electrodes of the electrode array.

109. A method comprising: administering therapeutic substances to the human body; as well as The concentration and / or amount of the substance in the human's cochlea is managed by taking into account the human's blood-labyrinth barrier.

110. The method of claim 109, wherein: By modifying the blood labyrinth barrier, the act of managing the concentration and / or amount is performed.

111. The method of claim 109, wherein: The therapeutic substance is administered locally and systemically; and The management of the concentration and / or amount of the substance is performed by balancing the local amount and the systemic amount.

112. The method of claim 109, wherein: The therapeutic substance is administered locally and systemically; and The amount of the substance to be administered locally and the amount of the substance to be administered systemically are determined based on the state of the blood labyrinth barrier.

113. The method of claim 109, wherein: The therapeutic substance is administered locally and systemically; and The amount of the substance administered locally and the amount of the substance administered systemically are determined to obtain a concentration gradient of the substance between the interior of the cochlea and the exterior of the cochlea, thereby managing the amount and / or concentration.

114. The method of claim 109, wherein: The therapeutic substance is administered locally and systemically; and The amount of the substance administered locally and the amount of the substance administered systemically are determined to maintain the concentration and / or amount of the substance in the cochlea, wherein the amount provided locally is less than the maximum amount that can be effectively applied.

115. The method of claim 109, wherein: In the act of managing the blood labyrinth barrier, the blood labyrinth barrier of the recipient is intentionally altered.

116. The method of claim 109, wherein: The act of managing the concentration and / or amount is performed by applying electrical stimulation from a cochlear implant electrode array located in the cochlea of ​​the recipient.

117. The method of claim 109, wherein: The act of managing the concentration and / or amount is performed by applying electrical stimulation from a cochlear implant electrode array located in the cochlea of ​​the recipient such that the Shannon limit is intentionally exceeded.

118. The method of claim 109, wherein: Managing the concentration and / or amount is performed by systemically delivering inflammatory substances to modify the blood labyrinth barrier.

119. The method of claim 109, wherein: The act of managing the concentration and / or amount is performed by systemically delivering an inflammatory substance to modify the blood labyrinth barrier, wherein the inflammatory substance, when in a first state, has a deleterious effect on tissues of the recipient if delivered systemically in an amount that opens the blood labyrinth barrier; The inflammatory agent is delivered systemically in a second state different from the first state, wherein the second state is a state that is less deleterious to tissues of the recipient relative to the first state; and The method further comprises the step of converting the inflammatory substance from the second state to the first state when the substance is proximate to the cochlea, thereby managing the concentration and / or amount of the substance in the cochlea.

120. The method of claim 109, wherein: The act of managing the concentration and / or amount is performed by applying electrical stimulation from a cochlear implant electrode array positioned in the cochlea of ​​the recipient such that an amount of platinum from electrodes comprising the electrode array diffuses from the electrodes in excess of an amount that occurs during normal operation of the electrode array to induce auditory perception.

121. A device comprising: An implantable device is configured to cause trauma in an anatomy of a recipient.

122. The apparatus of claim 121, wherein: The implantable device is a cochlear implant.

123. The apparatus of claim 121, wherein: The implantable device is configured to extend into the cochlea of ​​a recipient and electrically stimulate tissue within the recipient to induce the trauma.

124. The apparatus of claim 121, wherein: The implantable device is a cochlear electrode array configured to extend into the cochlea of ​​a recipient and to electrically stimulate tissue of the cochlea in various ways to induce auditory perception and to electrically stimulate tissue within the recipient to cause the trauma.

125. The apparatus of claim 121, wherein: The implantable device is a cochlear implant configured to extend into the cochlea of ​​a recipient and to electrically stimulate tissue of the cochlea in various ways to induce auditory perception and to electrically stimulate tissue inside the recipient to cause the trauma without inducing auditory perception.

126. The apparatus of claim 121, wherein: The implantable device is configured to passively induce the wound.

127. The apparatus of claim 121, wherein: The implantable device is a drug delivery device.

128. The apparatus of claim 121, wherein: The implantable device is configured to detect a physical phenomenon inside the cochlea and to cause the trauma upon detecting the physical phenomenon.

129. The apparatus of claim 121, wherein: The implantable device is configured to detect a physical phenomenon inside the cochlea by monitoring at a location outside the cochlea, and then, upon detecting the physical phenomenon, open the tight junctions of cells at the round window.

130. The apparatus of claim 121, wherein: The implantable device is configured to detect a physical phenomenon inside the cochlea by monitoring at the round window niche of the recipient, and then to open tight junctions of cells at the round window upon detecting the physical phenomenon.

131. The apparatus of claim 121, wherein: The anatomical structure is the inner ear and / or the middle ear.

132. A device comprising: a device for monitoring physical phenomena within the recipient's anatomy; as well as Means for managing a barrier between a blood vessel and tissue of an organ of the recipient based on the monitored physical phenomenon.

133. The apparatus of claim 132, wherein: The act of managing the barrier includes inducing a change in the barrier of the recipient based on the monitored physical phenomenon.

134. The apparatus of claim 132, wherein: The physical phenomena are those associated with ototoxicity.

135. The apparatus of claim 133, wherein: said alteration of said barrier is an increase in the permeability of said barrier; and Due to the increase in permeability, the amount and / or concentration of the substance in the anatomical structure is reduced relative to a situation in the absence of the increase in permeability.

136. The apparatus of claim 135, wherein: The substance is a drug that is introduced into the body of the recipient at a location remote from the anatomical structure and is not related to hearing disease.

137. The apparatus of claim 133, wherein: said alteration of said barrier is an increase in the permeability of said barrier; and Due to the increase in permeability, the amount and / or concentration of a substance in the anatomical structure is increased relative to a situation in the absence of the increase in permeability.

138. The apparatus of claim 137, wherein: The substance is a drug that is introduced into the body of the recipient at a location remote from the anatomical structure and is a drug related to the treatment of the recipient's hearing system.

139. The apparatus of claim 132, wherein: The management of the barrier is at least one of: limiting an increase in the permeability of the barrier, inducing a decrease in the permeability of the blood labyrinth barrier, or preventing an increase in the permeability of the barrier relative to the absence of the management; and As a result of the administration, the amount and / or concentration of the substance in the anatomical structure is increased relative to a situation in the absence of the reduction in permeability.

140. The apparatus of claim 139, wherein: The substance is a drug that is introduced into the body of the system at a location within and / or near the anatomical structure.

141. The apparatus of claim 132, wherein: The act of inducing a change in the barrier of the recipient is performed via the infusion of an inflammatory compound into the scala tympani of the anatomical structure.

142. The apparatus of claim 132, wherein The anatomical structure is the cochlea.

143. A device comprising: devices for administering therapeutic substances to humans; as well as Means for causing a wound in or near an anatomical structure of the person, thereby adjusting the concentration and / or amount of the therapeutic substance in the anatomical structure relative to a situation in the absence of the wound.

144. The apparatus of claim 143, wherein: The modulation is a decrease in the amount and / or concentration of the therapeutic substance in the anatomical structure relative to a situation in the absence of the trauma.

145. The apparatus of claim 143, wherein: The modulation is an increase in the amount and / or concentration of the therapeutic substance in the anatomical structure relative to a situation in the absence of the trauma.

146. The apparatus of claim 143, wherein: The anatomical structure is the cochlea.

147. The apparatus of claim 143, wherein: The anatomical structure is one of a kidney or an eye.

148. The apparatus of claim 143, wherein: The anatomical structure is the cochlea; The human is a recipient of a cochlear implant comprising an electrode array inserted into the cochlea; and The cochlear implant causes the trauma.

149. The apparatus of claim 148, further comprising: automatically providing, via the cochlear implant and / or a support device for the cochlear implant, at least one of a reminder or a query, respectively, to the person, thereby directing the person to perform an action to administer the therapeutic substance to the person; receiving feedback from the person in response to the automatic providing, the feedback indicating that the person has administered the therapeutic substance to himself / herself and has thereby performed an action of administering a therapeutic substance to the person; and Based on the feedback received, the trauma is inflicted using the cochlear implant.

150. The apparatus of claim 143, wherein: The act of causing trauma is performed by applying a stimulus to the structure of the person.

151. The apparatus of claim 150, wherein: The stimulant is at least one of a chemical-based stimulant or a mechanical-based stimulant.

152. The apparatus of claim 150, wherein: The stimulus is applied to structures of the middle ear and / or cochlea; and The act of administering the therapeutic substance to the person is performed by administering the substance at a location remote from the structure.

153. The apparatus of claim 143, wherein: The anatomical structure is the cochlea; The human is a recipient of a cochlear implant comprising an electrode array inserted into the cochlea; and The cochlear implant causes the trauma by exceeding the Shannon limit of the electrodes of the electrode array.

154. A system comprising: An implantable device configured to influence a barrier between a person's blood vessels and tissue of an organ to control an amount of a substance in the anatomical structure beyond that which would have occurred in the absence of the influence.

155. The system of claim 154, further comprising: An implantable sensory prosthesis component, wherein the implantable device is integrated with the sensory prosthesis component.

156. The system of claim 154, wherein: The implantable device is configured to deliver an inflammatory substance to or proximate to the anatomical structure.

157. The system of claim 154, wherein: The implantable device is part of an implantable drug delivery device, wherein the drug delivery device is configured to deliver the substance to the anatomical structure.

158. The system of claim 154, wherein: The implantable device passively manages the barrier.

159. The system of claim 154, wherein: The implantable device actively manages the barrier.

160. The system of claim 154, wherein: The implantable device is configured to induce a foreign body response and is subsequently encapsulated to manage the barrier.

161. A device comprising: devices for administering therapeutic substances to humans; as well as Means for managing the concentration and / or amount of said substance in said person's anatomy by taking into account barriers between blood vessels and tissues of organs of said person.

162. The apparatus of claim 161, wherein: By modifying the barrier, an action of managing the concentration and / or amount is performed.

163. The apparatus of claim 161, wherein: The therapeutic substance is administered locally and systemically; and The management of the concentration and / or amount of the substance is performed by balancing the local amount and the systemic amount.

164. The apparatus of claim 161, wherein: The therapeutic substance is administered locally and systemically; and The amount of the substance to be administered locally and the amount of the substance to be administered systemically are determined based on the state of the barrier.

165. The apparatus of claim 161, wherein: The therapeutic substance is administered locally and systemically; and The amount of the substance administered locally and the amount of the substance administered systemically are determined to obtain a concentration gradient of the substance between the interior of the anatomical structure and the exterior of the anatomical structure, thereby managing the amount and / or concentration.

166. The apparatus of claim 161 , wherein: The therapeutic substance is administered locally and systemically; and The amount of the substance administered locally and the amount of the substance administered systemically are determined to maintain the concentration and / or amount of the substance in the anatomical structure, wherein the amount provided locally is less than the maximum amount that can be effectively applied.

167. The apparatus of claim 161, wherein: In the act of managing the barrier, the barrier of the recipient is intentionally altered.

168. The apparatus of claim 161 , wherein: Managing the concentration and / or amount is performed by applying electrical stimulation from an anatomically implanted electrode array located in the anatomy of the recipient.

169. The apparatus of claim 161, wherein: The act of managing the concentration and / or amount is performed such that the Shannon limit is intentionally exceeded by applying electrical stimulation from an anatomically implanted electrode array located in the anatomy of the recipient.

170. The apparatus of claim 161, wherein: Managing the concentration and / or amount is performed by systemically delivering inflammatory substances to modify the barrier.

171. The apparatus of claim 161, wherein: Managing the concentration and / or amount is performed by systemically delivering an inflammatory substance to modify the barrier, wherein the inflammatory substance, when in a first state, has a deleterious effect on tissues of the recipient if delivered systemically in an amount that opens the barrier; The inflammatory substance is systemically delivered in a second state different from the first state, wherein the second state is a state that has less deleterious effects on tissues of the recipient relative to the first state; and The device further includes transitioning the inflammatory substance from the second state to the first state when the substance is proximate to the anatomical structure, thereby managing the concentration and / or amount of the substance in the anatomical structure.

172. The apparatus of claim 161, wherein: The act of managing the concentration and / or amount is performed by applying electrical stimulation from an anatomically implanted electrode array located in the anatomy of the recipient so that an amount of platinum diffusing from the electrodes comprising the electrode array exceeds an amount that occurs during normal operation of the electrode array to induce auditory perception.

173. The apparatus of claim 161, wherein: The anatomical structure is the cochlea.

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