Skin flap management for medical devices having a transcutaneous link

Abstract

Methods and systems for evaluating tissue health of a recipient comprising receiving a measuring command at a sensor comprising at least one light emitting diode (LED) and a light detector are disclosed. The method further comprises emitting one or more light beams from the at least one LED in a direction of a medical device wherein the medical device is implanted subcutaneously or percutaneously in the recipient. The light detector receives one or more reflected light beams. The intensity of the reflected light beams from the light detector is measured and is used to determine an oxygen saturation value.

Description

SKIN FLAP MANAGEMENT FOR MEDICAL DEVICES HAVING A TRANSCUTANEOUS LINKInventor: Peter AnderssonTECHNICAL FIELD

[0001] The technical field is management of skin or soft tissue health surrounding medical devices implantable in a recipient and having a transcutaneous link.BACKGROUND

[0002] Medical devices are devices that are intended to be used for medical purposes. They can vary in both their intended use and indications for use. Examples range from simple, low-risk medical supplies, such as tongue depressors, medical thermometers, disposable gloves, and bedpans, to complex, potentially high-risk devices that are implanted and / or sustain life, such as deep brain stimulators and cardiac stents. Other categories of medical device include diagnostic equipment, such as x-ray machines and ultrasound scanners, life support equipment, such as mechanical ventilators and dialysis machines.

[0003] Hearing devices act on an actual or potential auditory perception of an individual, including to improve perception of sound signals, to reduce perception of sound signals, etc. In particular, a hearing device can deliver sound signals to a user in any form, including in the form of acoustical stimulation, mechanical stimulation, electrical stimulation, etc., and / or can operate to suppress all or some sound signals. As such, a hearing device can be a device for use by a hearing-impaired person (e.g., hearing aids, middle ear auditory prostheses, bone conduction devices, direct acoustic stimulators, electro-acoustic hearing prostheses, auditory brainstem stimulators, bimodal hearing prostheses, bilateral hearing prostheses, dedicated tinnitus therapy devices, tinnitus therapy devices, etc.) or a device for use by a person with normal hearing (e.g., consumer devices that provide audio streaming, consumer headphones, earphones and other listening devices), a hearing protection device, etc.SUMMARY

[0004] In some embodiments, various devices, systems, structures, and methods are disclosed for a medical device implantable in a recipient. The medical device comprises an implantable portion and an external portion. The external portion comprises a light source and a light detector, wherein the light source is configured to transmit a plurality of light beams in a vicinity of the implantable portion. The light detector is configured for receiving a plurality of reflected light beams from the vicinity of the implantable portion. The medical device further comprises at least one processor associated with the external portion and the implantable portion, wherein the at least one processor is configured to determine an oxygen saturation value at least in part based on the one or more intensity measurements received from the light detector.

[0005] Embodiments of the disclosed invention comprise a method for evaluating tissue health of a recipient comprising receiving a measuring command at a sensor comprising at least one light emitting diode (LED) and a light detector. The method further comprises emitting one or more light beams from the at least one LED in a direction of a medical device wherein the medical device is implanted subcutaneously in the recipient. The light detector receives one or more reflected light beams. The intensity of the reflected light beams from the light detector is measured and is used to determine an oxygen saturation value.

[0006] Embodiments of the disclosed invention also include a system for evaluating tissue health of a recipient comprising a medical device that is implanted subcutaneously in the patient. The system further includes a sensor comprising at least one light emitting diode (LED) and a light detector. At least one processor is coupled to the sensor. The processor is configured to receive a measuring command from a remote device and instruct the at least one LED to emit one or more light beams from the at least one LED in the direction of the subcutaneously implanted medical device. The processor then records at least one intensity measurement for one or more reflected light beams received at the light detector; and determines an oxygen saturation value based at least in part on the intensity measurement of the one or more reflected light beams from the light detector.

[0007] Some embodiments of the disclosed invention comprise a non-transitory computer readable medium including computer rpad ble code, which, upon execution by one ormore processors operably connected to a sensor comprising at least one light emitting diode (LED) and a light detector, causes the one or more processors to receive a blood flow measuring command from a remote device. The one or more processors further cause the at least one LED to emit one or more light beams toward a skin surface of the recipient that is adjacent to a medical device implanted percutaneously in the recipient, the medical device comprising at least one abutment and at least one implant configured to be operably connected to the at least one abutment. The one or more processors further receives at least one intensity measurement of one or more reflected light beams striking a light detector and determines at least one oxygen saturation value based at least in part on the at least one intensity measurement of the one or more reflected light beams from the light detector.

[0008] This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. Various objects, features, aspects, and advantages of the inventive subject matter will become more apparent from the following Detailed Description, along with the accompanying drawing figures in which like numerals represent like components.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] For the purposes of illustration only, several aspects of embodiments of the invention are described by reference to the following figures. In the following figures, the same number represents the same type of element in all drawings.

[0010] FIG. 1A illustrates a schematic diagram of an exemplary cochlear implant system configured to implement aspects of the technologies presented herein;

[0011] FIG. IB illustrates a block diagram of the exemplary cochlear implant system of FIG. 1A;

[0012] FIG. 2 illustrates a block diagram of an example implantable auditory prosthesis system that includes an auditory prosthesis that can benefit from use of the technologies described herein;

[0013] FIG. 3 illustrates a flowchart depicting a method for evaluating tissue health of a recipient as described herein;

[0014] FIG. 4 illustrates a flowchart depicting another method for evaluating tissue health of a recipient as described herein;

[0015] FIG. 5 illustrates a schematic diagram of a technique to measure blood flow utilized in aspects of the technologies described herein;

[0016] FIG. 6 illustrates a schematic diagram of aspects of an implantable medical device system as described herein;

[0017] FIG. 7 illustrates a schematic diagram of aspects of a second embodiment of an implantable medical device as described herein;

[0018] FIG. 8 shows an example of a computer system, one or more of which may be used to implement one or more of the apparatuses, systems, and methods illustrated herein.

[0019] While the invention is described with reference to the above drawings, the drawings are intended to be illustrative, and other embodiments are consistent with and within the scope, of the invention.DETAILED DESCRIPTION

[0020] There are a number of different types of devices in / with which the techniques presented herein can be implemented. Merely for ease of description, the techniques presented herein are primarily described with reference to a specific medical device in the form of a hearing prosthesis. However, it is to be appreciated that the techniques presented herein can also be partially or fully implemented by any of a number of different types of devices or systems, including consumer electronic devices (e.g., consumer hearing devices, consumer computing devices such as mobile phones and tablets, audio equipment such as home theatre and car audiosystems, etc.), computing systems (e.g., servers in data centers, Internet-of-Things (loT) devices), various types of software systems, such as databases, machine learning and artificial intelligence systems, other medical devices, such as diagnostic equipment or life sustaining equipment, etc. For example, the techniques presented herein could be used in or with hearing devices, various implantable medical devices, such as vestibular implants, visual implants (e.g., bionic eyes), pacemakers, drug delivery systems, implantable defibrillators, functional electrical stimulation devices, catheters, implantable seizure devices (e.g., devices for monitoring and / or treating epileptic events), implantable sleep apnea devices, etc.

[0021] All publications identified herein are incorporated by reference to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.

[0022] Embodiments of the disclosed technology are directed to improvements in the management of necrosis risk in a skin flap of a recipient associated with a transcutaneous closely coupled induction link used in many implantable medical devices. In some embodiments, an external coil assembly includes a coil and a permanent magnet which is attracted to a permanent magnet associated with a corresponding implanted coil assembly. Thus, the external coil assembly can be held in position to enable the transcutaneous link to continue functioning, even while the recipient of the implantable medical device engages in everyday activities. However, the recipient’s skin flap can be subject to pressure created by the external and implanted magnets, which in turn requires managing the risk of necrosis believed to be due to lack of blood circulation.

[0023] One approach to managing necrosis is to measure the skin flap thickness as part of a clinical review of the recipient’s implantable medical device, and to calculate and select a suitable external magnet strength based on heuristics. Thus, the clinician or health care provider has an opportunity to choose the magnet strength in the external sound processor of an implantable medical device, for example. If the magnet chosen is too strong, and the recipienthas been wearing it a long time, the blood flow may be restricted. When the blood flow is too little, there is a risk that the skin tissue may die, and necrosis will develop.

[0024] Alternative systems propose to monitor and automatically adjust the attractive magnetic force between the external and internal magnets to within predetermined target ranges known to minimize necrosis risk, while still providing acceptable retention of the external coil. Examples of such technologies are discussed in commonly owned U.S. Patent No. 10,893,369 and U.S. Patent No. 11,012,796, both of which are assigned to Cochlear Ltd., and each of which are herein incorporated by reference in their entirety.

[0025] Very little is known about necrosis other than research studies that are conducted on an ad hoc basis. Today, otolaryngologists and surgeons specializing in otolaryngology often use a manual checklist to check for problems with necrosis in recipients of implantable medical devices. Thus, there is a gap in field data regarding when skin tissue is at risk of developing necrosis and a gap in monitoring skin tissue for necrosis between clinic visits when the recipient is at home and / or going about daily activities of living.

[0026] Embodiments of the disclosed invention can more effectively manage skin flap necrosis risk in implementations that directly monitor blood oxygen saturation and hence blood flow directly at the skin flap. In one example, an optical sensor outputs a light source directed through the skin flap. A photoelectric receiver measures the amount of light that is absorbed and / or reflected back. In some embodiments, the optical sensor can be directly incorporated into the externally worn assembly of an implantable medical device. An externally worn assembly can take the form of a coil assembly, or a speech processor including a coil assembly, or a power source including a coil assembly, among other implementations. Such novel approaches for managing necrosis risk are suitable for long-term monitoring and can be less affected by changes in skin flap thickness over time, and / or inaccuracies of inferred and / or predetermined estimations of acceptable magnetic force to reduce necrosis risk for particular recipients of the implantable medical devices. Such approaches can also provide improved feedback for the user (e.g., a clinician) and / or recipient of the implantable medical device as to necrosis risks when the recipient wishes to temporarily increase the magnetic retention of their medical device, e.g., during vigorous physical activities like running, jumping and / or other active outdoor sports orpursuits. In this example, it is important to monitor that there is enough blood flow over the internal implant (attachment area) when wearing the externally worn assembly, such as an external sound processor.

[0027] FIG. 1A is a schematic diagram of an exemplary cochlear implant 100 that can be configured to implement aspects of the technologies presented herein, while FIG. IB is a block diagram of the cochlear implant 100 shown in FIG. 1A. For ease of illustration, FIGs. 1A and IB will be described together. Although aspects of the technologies presented herein are discussed in the context of the exemplary cochlear implant 100 shown in FIGs. 1A and IB, it is understood that the technologies described herein can be implemented in any of a wide range of implantable medical devices, including devices that include a transcutaneous closely coupled induction link used in many implantable medical devices. Other examples of implantable medical devices that can utilize the technologies described herein include implantable medical devices for vestibular stimulation, implantable medical devices for deep brain stimulation, medical devices having a closely coupled magnetic induction link, or any other implantable medical devices with a rechargeable battery.

[0028] In some examples of implantable medical devices, an external coil assembly includes a coil and a permanent magnet which is attracted to an implantable or internal component including a permanent magnet associated with a corresponding implanted coil assembly. As discussed above, the external coil assembly can be held in position using the magnet, for example, to enable the transcutaneous link to continue functioning, even while the recipient of the implantable medical device engages in everyday activities. However, the technologies described herein for managing the necrosis risk and measuring tissue health of recipients in regions surrounding the recipient’s implantable medical devices can be used with fully implantable medical devices that do not include an external component portion, for example. In other examples, the technologies described herein for measuring tissue health and managing necrosis risk in regions surrounding the recipient’s implantable medical devices may similarly be used with attachment mechanisms other than magnets for attaching the implantable medical device to an external component portion. For example, an anchor or fixation system can include a percutaneous abutment (not shown) implanted in a recipient and fixed to the recipient’s skull bone. Such an abutment can, for example, extend through muscle, fat, and skin so that acoupling apparatus can be attached thereto, such that the percutaneous abutment provides an attachment location for the coupling apparatus that facilitates efficient transmission of mechanical force.

[0029] The exemplary cochlear implant 100 depicted in FIG. 1A comprises an external component 102 and an internal / implantable component 104. The external component 102 is directly or indirectly attached to the body of the recipient and typically comprises an external coil 106 and, generally, a magnet (not shown in FIGs. 1A or IB) fixed relative to the external coil 106. The external component 102 also comprises one or more input elements / devices 113 for receiving input signals at a sound processing unit 112. In this example, the one or more one or more input devices 113 include sound input devices 108 (e.g., microphones positioned by auricle 110 of the recipient, telecoils, etc.) configured to capture / receive input signals, one or more auxiliary input devices 109 (e.g., audio ports, such as a Direct Audio Input (DAI), data ports, such as a Universal Serial Bus (USB) port, cable port, etc.), and a wireless transmi tter / recei ver (transceiver) 111, each located in, on, or near the sound processing unit 112.

[0030] With reference to FIG. IB, the sound processing unit 112 also includes, for example, at least one battery 107, a radio-frequency (RF) transceiver 121, and a processing module 125. The processing module 125 comprises a number of elements, including one or more light sources 137, at least one light detector 138, an environmental classifier 131, a sound processor 133, and an individualized own voice detector 134. Each of the environmental classifier 131, the sound processor 133, and the individualized own voice detector 134 may be formed by one or more processors (e.g., one or more Digital Signal Processors (DSPs), one or more uC cores, etc.), firmware, software, etc. arranged to perform operations described herein. That is, the environmental classifier 131, the sound processor 135, and the individualized own voice detector 134 may each be implemented as firmware elements, partially or fully implemented with digital logic gates in one or more application-specific integrated circuits (ASICs), partially or fully in software, etc.

[0031] The individualized own voice detector 134 includes a decision tree, sometimes referred to herein as an own voice detection decision tree, that can be trained / updated. Similarly, the environmental classifier 131 includes a decision tree, sometimes referred to as anenvironmental classifier decision tree that, in certain embodiments, can also be trained / updated. To provide the ability to train / update the own voice detection decision tree and / or the environmental classifier decision tree, the decision trees are stored in volatile memory and exposed to, for example, other process for updating thereof. As such, the environmental classifier 131 and the individualized own voice detector 134 are at least partially implemented in volatile memory.

[0032] In the examples of FIGs. 1A and IB, the sound processing unit 112 is a behind- the-ear (BTE) sound processing unit configured to be attached to, and worn adjacent to, the recipient’s ear. However, it is to be appreciated that embodiments of the present invention may be implemented by sound processing units having other arrangements, such as by an OTE processing unit (e.g., a component having a generally cylindrical shape and which is configured to be magnetically coupled to the recipient’s head), etc., a mini or micro-BTE unit, an in-the- canal unit that is configured to be located in the recipient’s ear canal, a body-worn sound processing unit, etc.

[0033] Returning to the example embodiment of FIGs. 1A and IB, the implantable component 104 comprises an implant body (main module) 114, a lead region 116, and an intra- cochlear stimulating assembly 118, all configured to be implanted under the skin / tissue (tissue) 105 of the recipient. The implant body 114 generally comprises a hermetically sealed housing 115 in which RF interface circuitry 124 and a stimulator unit 120 are disposed. The implant body 114 also includes an internal / implantable coil 122 that is generally external to the housing 115, but which is connected to the RF interface circuitry 124 via a hermetic feedthrough (not shown in FIG. IB).

[0034] As noted, stimulating assembly 118 is configured to be at least partially implanted in the recipient’s cochlea 137. Stimulating assembly 118 includes a plurality of longitudinally spaced intra-cochlear electrical stimulating contacts (electrodes) 126 that collectively form a contact or electrode array 128 for delivery of electrical stimulation (current) to the recipient’s cochlea. Stimulating assembly 118 extends through an opening in the recipient’s cochlea (e.g., cochleostomy, the round window, etc.) and has a proximal end connected to stimulator unit 120 via lead region 116 and a hermetic feedthrough (not shown in FIG. IB). Lead region 116includes a plurality of conductors (wires) that electrically couple the electrodes 126 to the stimulator unit 120.

[0035] As noted, the cochlear implant 100 includes the external coil 106 and the implantable coil 122. The coils 106 and 122 are typically wire antenna coils each comprised of multiple turns of electrically insulated single-strand or multi-strand platinum or gold wire. Generally, a magnet is fixed relative to each of the external coil 106 and the implantable coil 122. The magnets fixed relative to the external coil 106 and the implantable coil 122 facilitate the operational alignment of the external coil with the implantable coil. This operational alignment of the coils 106 and 122 enables the external component 102 to transmit data, as well as possibly power, to the implantable component 104 via a closely-coupled wireless link formed between the external coil 106 with the implantable coil 122. In certain examples, the closely- coupled wireless link is a radio frequency (RF) link. However, various other types of energy transfer, such as infrared (IR), electromagnetic, capacitive and inductive transfer, may be used to transfer the power and / or data from an external component to an implantable component and, as such, FIG. IB illustrates only one example arrangement.

[0036] As noted above, sound processing unit 112 includes the processing module 125. The processing module 125 is configured to convert input audio signals into stimulation control signals 136 for use in stimulating a first ear of a recipient (i.e., the processing module 125 is configured to perform sound processing on input audio signals received at the sound processing unit 112). Stated differently, the sound processor 133 (e.g., one or more processing elements implementing firmware, software, etc.) is configured to convert the captured input audio signals into stimulation control signals 136 that represent electrical stimulation for delivery to the recipient. The input audio signals that are processed and converted into stimulation control signals may be audio signals received via the sound input devices 108, signals received via the auxiliary input devices 109, and / or signals received via the wireless transceiver 111.

[0037] In the embodiment of FIG. IB, the stimulation control signals 136 are provided to the RF transceiver 121, which transcutaneously transfers the stimulation control signals 136 (e.g., in an encoded manner) to the implantable component 104via external coil 106 and implantable coil 122. That is, the stimulation control signals 136 are received at the RFinterface circuitry 124 via implantable coil 122 and provided to the stimulator unit 120. The stimulator unit 120 is configured to utilize the stimulation control signals 136 to generate electrical stimulation signals (e.g., current signals) for delivery to the recipient’s cochlea via one or more stimulating contacts 126. In this way, cochlear implant 100 electrically stimulates the recipient’s auditory nerve cells, bypassing absent or defective hair cells that normally transduce acoustic vibrations into neural activity, in a manner that causes the recipient to perceive one or more components of the input audio signals.

[0038] As noted, in addition to the sound processor 133, the processing module 125 also includes the environmental classifier 131. As described further below, the environmental classifier 131 (e.g., one or more processing elements implementing firmware, software, etc.) is configured to determine an environmental classification of the sound environment (i.e., determines the “class” or “category” of the sound environment) associated with the input audio signals received at the cochlear implant 100. In addition, also as described further below, the processing module 125 comprises the individualized own voice detector 135 (e.g., one or more processing elements implementing firmware, software, etc.) that is configured to perform individualized own voice detection (OVD). As used herein, own voice detection (OVD) generally refers to a process in which speech signals received at a hearing prosthesis are classified as either including the speech of the recipient of the hearing prosthesis (referred to herein as the recipient’s own voice or simply own voice) or speech generated by one or more persons other than the recipient (referred to herein as external voice). Also as used herein, individualized own voice detection (or individualized OVD) refers to own voice detection that is recipient-specific, meaning the own voice detection is at least partly trained to perform the own voice detection using (based on) the specific voice (speech) of the recipient of the hearing prosthesis, as captured by the hearing prosthesis itself. As a result, the individualized own voice detection is specific / customized to the recipient of the hearing prosthesis and to the hearing prosthesis itself.Example auditory prosthesis system

[0039] FIG. 2 illustrates an example auditory prosthesis system 200 that includes an auditory prosthesis 210 that includes an implantable medical device can benefit from the use oftechnologies described herein. The system 200 further includes a recipient computing device 220, a clinician computing device 230, and a server 240, which are connected over a network 202. As mentioned above with respect to FIGs. 1 A and IB, although aspects of the technologies presented herein are discussed in the context of the exemplary auditory prosthesis system 200, it is understood that the technologies described herein can be implemented in any of a wide range of implantable medical devices, including devices that include a transcutaneous closely coupled induction link used in many implantable medical devices. Other examples of implantable medical devices that can utilize the technologies described herein include implantable medical devices for vestibular stimulation, implantable medical devices for deep brain stimulation, medical devices having a closely coupled magnetic induction link, or any other implantable medical devices with a rechargeable battery.

[0040] The network 202 is a computer network, such as the Internet, that facilitates the communication of data among computing devices connected to the computer network.

[0041] As illustrated, the auditory prosthesis 210 and the recipient computing device 220 are operated by the recipient in an environment 201. The environment 201 defines the conditions in which the auditory prosthesis 210 and the recipient computing device 220 operate. In many examples herein, the environment 201 includes the sonic conditions in which the auditory prosthesis 210 functions. Such sonic conditions can include, for example, a loudness of noise (e.g., whether the environment 201 is loud or quiet), a number of sources of noise (e.g., a crowded restaurant with many sources of noise or a one-on-one conversation with fewer sources of noise) and a kind of noise (e.g., music or speech). The environment 201 can also define an activity in which the recipient is engaged, such as a conversation or exercise. The environment 101 can affect the operation of the auditory prosthesis 210, and the auditory prosthesis 210 can be customized to operate differently in different environments 201.

[0042] The auditory prosthesis 210 is a medical apparatus relating to a recipient’s auditory system, such as a cochlear implant or bone conduction devices (e.g., percutaneous bone conduction devices, transcutaneous bone conduction devices, active bone conduction devices, and passive bone conduction devices), and middle ear stimulators, among others. The auditory prosthesis 210 can take any of a variety of forms. In the illustrated example, the auditoryprosthesis includes an auditory prosthesis sensor set 212 and operates according to auditory prosthesis settings 214.

[0043] The auditory prosthesis sensor set 212 is a collection of one or more hardware or software components of the auditory prosthesis 210 that obtain data, such as data regarding the environment 201, the auditory prosthesis 210, or the recipient. In many examples, the auditory prosthesis sensor set 212 include a microphone (e.g., an implanted or external microphone). The auditory prosthesis sensor set 212 can include one or more other sensors, such as one or more accelerometers, gyroscopic sensors, location sensors, telecoils, biosensors (e.g., heart rate or blood pressure sensors), and light sensors, among others. The auditory prosthesis sensor set 212 can include components disposed within a housing of the auditory prosthesis 210 as well as devices electrically coupled to the auditory prosthesis 210 (e.g., via wired or wireless connections). In examples, the auditory prosthesis sensor set 212 includes a remote device connected to the auditory prosthesis 210 via an FM (Frequency Modulation) connection, such as a remote microphone (e.g., a COCHLEAR TRUE WIRELESS MINI MICR0PH0NE2+), a television audio streaming device, or a phone clip device, among other devices having FM transmission capabilities. The auditory prosthesis sensor set 212 can further include sensors that obtain data regarding usage of the auditory prosthesis 210, such as software sensors operating on the auditory prosthesis 210 that track: when the auditory prosthesis 210 is worn by the recipient, when the auditory prosthesis 210 (e.g., an external portion thereof) is removed from the recipient, when one or more of the auditory prosthesis settings 214 are modified, and how long the auditory prosthesis 210 is operated using particular settings of the auditory prosthesis settings 214, among other data.

[0044] In some examples, the auditory prosthesis 210 can be used as shown in implantable medical device system 600 of FIG.6, where the auditory prosthesis 210 comprises an external component 102 and an implantable component 104. Auditory prosthesis sensor set 212 comprises a portion of external component 102, and in examples includes one or more LEDs 510 and at least one photodetector or light sensor 520. In some examples, auditory prosthesis sensor set 212 is positioned adjacent to the recipient’s skin surface in a vicinity of implantable component 104. Auditory prosthesis 210 is communicatively coupled to recipient computing device 220 in the examples discussed herein using a wireless communications protocol such asBluetooth Low Energy (BLE). Recipient computing device is also communicatively coupled to clinician computing device 230 through network 202 as disclosed herein with respect to some examples.

[0045] In examples, the auditory prosthesis sensor set 212 can further include a scene classifier. A scene classifier is a hardware- or software-implemented classifier that obtains data regarding the environment 201 (e.g., from one or more other sensors of the auditory prosthesis sensor set 212) and determines a classification of the environment 201. Classifications can include, for example, speech, noise, and music, among other classifications. The auditory prosthesis 210 can then use the classification to automatically switch the auditory prosthesis settings 214 to suit the environment 201. An example scene classifier is described in US 2017 / 0359659, filed June 9, 2016, and entitled “Advanced Scene Classification for Prosthesis”, which is incorporated by reference herein in its entirety for any and all purposes. The classification can serve as useful data on which changes to auditory prosthesis settings 214 are based.

[0046] The auditory prosthesis settings 214 are one or more parameters having values that affect how the auditory prosthesis 210 operates. For instance, the auditory prosthesis settings 214 can include a map having minimum and maximum stimulation levels for frequency bands of stimulation channels. The map is then used by the auditory prosthesis 210 to control an amount of stimulation to be provided. For instance, where the auditory prosthesis 210 is a cochlear implant, the map affects which electrodes of the cochlear implant to stimulate and in what amount based on a received sound input. In some examples, the auditory prosthesis settings 214 include two or more predefined groupings of settings selectable by the recipient. One of the two or more predefined groupings of settings may be a default setting.

[0047] The auditory prosthesis settings 214 can also include sound processing settings that modify sound input before it is converted into a stimulation signal. Such settings can include, for example, particular audio equalizer settings can boost or cut the intensity of sound at various frequencies. In examples, the auditory prosthesis settings 214 can include a minimum threshold for which received sound input causes stimulation, a maximum threshold for preventing stimulation above a level which would cause discomfort, gain parameters, loudnessparameters, and compression parameters. The auditory prosthesis settings 214 can include settings that affect a dynamic range of stimulation produced by the auditory prosthesis 210. As described above, many of the auditory prosthesis settings 214 affect the physical operation of the auditory prosthesis 210, such as how the auditory prosthesis 210 provides stimulation to the recipient in response to sound input received from the environment 201.

[0048] The recipient computing device 220 is a computing device associated with the recipient of the auditory prosthesis 210. In many examples, the recipient computing device 220 is a cell phone (e.g., smart phone), smart watch, or heart rate monitor, but can take other forms. Although described primarily in the context of the recipient, the recipient computing device 220 can be a computing device owned or primarily used by a parent or caregiver for the recipient. As illustrated, the recipient computing device 220 includes a recipient computing device sensor set 222. In examples of the technologies disclosed herein, recipient computing device 220 further includes one or more light sources (not shown in FIG. 2), such as one or more light emitting diodes (LEDs). An exemplary light source is depicted as LED 510 shown with respect to optoelectronic sensor 501 shown in FIG. 5 which depicts a technique 500 for using optoelectronic sensor 501 to measure tissue health of a recipient in examples described herein. In FIG. 5, light beams 515 emitted from LED 510 is transmitted through the surface of the skin and through the upper layers of the skin, e.g., epidermis 540 through dermis 550. The light beams 515 are reflected off of erythrocytes (red blood cells 535) in capillary vessel 530 and are absorbed and measured at photodetector 520. The measurements of the intensities of the light beams by photodetector 520 can be used to assess the tissue health of the recipient in the area of the recipient’s skin where the light beams are directed. In one example, as shown with respect to FIG. 7, LED 510 is a flash light on a smart phone (e.g., recipient computing device) 220, and photodetector (e.g., light sensor) 520 comprises a camera on smart phone 220, which is used to measure the tissue health (e.g., blood flow) of a skin flap (e.g., skin tissue) of a recipient 701 of an implantable medical device component 104 when camera 520 and light source 510 of smart phone 220 are pointed at a skin flap of recipient 701 covering implantable medical device component 104. Exemplary techniques for utilizing photoplethysmography (PPG) sensors to measure the flow of blood and oxygen to capillary vessels are discussed, for example, in the following reference, which is incorporated by reference herein in its entirety: Moraes, J. et al.,Advances in Photoplethysmography Signal Analysis for Biomedical Applications, Sensors 2018, 18, 1894 (doi: 10.3390 / s 18061894)

[0049] The recipient computing device sensor set 222 is group of one or more components of the recipient computing device 220 that obtains data. The recipient computing device sensor set 222 can include one or more sensors, such as microphones, accelerometers, gyroscopic sensors, location sensors, biosensors (e.g., heart rate or blood pressure sensors), magnetic sensors (e.g., Hall sensors), and light sensors, among others. The recipient computing device sensor set 222 can include components disposed within a housing of the recipient computing device 220 as well as devices electrically coupled to the recipient computing device 220 (e.g., via wired or wireless connections). In some examples, the recipient computing device sensor set 222 includes software sensors, such as software that obtains data from one or more data streams (e.g., audio streamed from the recipient computing device 220 to the auditory prosthesis 210). The recipient computing device sensor set 222 can further include sensors that obtain data regarding, e.g., tissue health, or how the recipient computing device 220 itself is being used.

[0050] In examples, the recipient computing device 220 includes an auditory prosthesis application 224 that operates on the recipient computing device 220 and cooperates with the auditory prosthesis 210. The auditory prosthesis application 224 is a computer program stored as computer-executable instructions in memory on the recipient computing device 220 that, when executed, performs one or more tasks relating to the auditory prosthesis 210. For instance, the auditory prosthesis application 224 can control the auditory prosthesis 210 (e.g., based on input received from the recipient), monitor usage of the auditory prosthesis 210, and obtain data from the auditory prosthesis 210. The recipient computing device 220 can connect to the auditory prosthesis 210 using, for example, a wireless radio frequency communication protocol (e.g., BLUETOOTH, or BLUETOOTH Low Energy (BLE)). The auditory prosthesis application 224 transmits or receives data from the auditory prosthesis 210 over such a connection. The auditory prosthesis application 224 can also stream audio to the auditory prosthesis 210, such as from a microphone of the recipient computing device sensor set 222 or an application running on the recipient computing device 220 (e.g., a video or audio application). In examples, the auditory prosthesis application 224 functions as part of the recipient computing device sensor set 222 byobtaining data regarding the auditory prosthesis 210. The recipient computing device 220 can be in communication with one or both of the clinician computing device 230 and the server 240, such as via the auditory prosthesis application 224 communicating over the network 202.

[0051] The clinician computing device 230 is a computing device used by a clinician. A clinician is a medical professional, such as an audiologist, an otolaryngologist, an internist or other primary care physician, or a nurse practitioner. In an example, the clinician is a medical professional that provides care or supervision for the recipient. The clinician computing device 230 includes one or more software programs usable to monitor or control the auditory prosthesis 210, such as customization of the auditory prosthesis settings 214.

[0052] The server 240 is a server remote from the auditory prosthesis 210, recipient computing device 220, and the clinician computing device 230. The server 240 is communicatively coupled to the recipient computing device 220 and the clinician computing device 230 via the network 202. In many examples, the server 240 is indirectly communicatively coupled to the auditory prosthesis 210 through the recipient computing device 220 (e.g., via the auditory prosthesis application 224). In some examples, the server 240 is directly communicatively coupled to the auditory prosthesis 210. The server 240 includes one or more server applications 242.

[0053] The one or more server applications 242 are computer programs stored as computer-executable instructions in memory on the server 240 that, when executed, perform one or more tasks relating to the system 200. The one or more server applications 242 are operable to perform one or more operations described herein, such as operations that customize the auditory prosthesis 210. As illustrated, the one or more server applications 242 operate on the server 240.

[0054] The components of the system 200 can cooperate to perform a method that improves the performance of the auditory prosthesis 210 or monitors the health of the recipient or the tissue surrounding the recipient’s auditory prosthesis 210.

[0055] FIG. 3 illustrates a flowchart depicting a method 300 for evaluating tissue health of a recipient as described herein. Process 300 starts at 302, then at operation 304, an auditoryprosthesis 210 of a recipient receives a tissue health (e.g., blood flow) measuring command from a user. A user can be the recipient who wishes to run a test to assess the recipient’s own tissue health or a clinician or health care professional such as an audiologist or primary care physician or otolaryngologist. At operation 306, auditory prosthesis 210 emits light beams at the recipient’s skin surface. At operation 308, auditory prosthesis 210 receives the reflected light beams at the light detector and transmits them to an auditory prosthesis application 224 as needed on recipient computing device 220. At operation 310, the light absorption patterns of the emitted and reflected light beams are analyzed to determine one or more oxygen saturation values. At operation 312, the one or more oxygen saturation values are compared with previous oxygen saturation measurements of the recipient and / or other. In one example, the oxygen saturation values can be compared using a machine learning model to determine if a decrease or absence of blood flow is detected in the scanned skin region and / or tissue of the recipient at operation 314. If the blood flow and / or tissue health looks healthy, and / or good and no adverse changes are detected at operation 315, the positive results can be reported to the recipient and the method will wait until the next testing time at operation 320. In some examples, the recipient’s clinician may set the auditory prosthesis application 224 to automatically test the recipient’s tissue health at regular intervals, e.g., biweekly, weekly, daily, every 12 hours, etc. in order to detect changes in the blood flow and / or tissue health in the vicinity of the implantable medical device. However, if a change is detected in the blood flow of the recipient at operation 314 (e.g., a decrease or absence of blood flow is detected), the recipient’s clinician or other health care provider is notified at operation 316 before the method ends at 320.

[0056] FIG. 4 illustrates a flowchart depicting another method 400 for evaluating tissue health of a recipient as described herein, using a recipient’s computing device (e.g., a mobile device such as a smart phone) to perform the measurement process. Process 400 starts at 402, then at operation 404, a recipient computing device 220 of a recipient receives a tissue health (e.g., blood flow) measuring command from a user. In one example, the measuring command is received through a mobile application (e.g., computer program product 860 in FIG. 8 as discussed below herein) that can be configured to communicate with the implantable medical device. A user can be the recipient, or a caregiver who wishes to run a test to assess the recipient’s own tissue health. In some examples, a clinician or health care professional such as anaudiologist or primary care physician or otolaryngologist can configure application 860 to perform the test to measure tissue health at pre-specified times or intervals, e.g., or every 12 hours, daily, weekly, monthly, or for a set of specified time intervals for a period of time following implantation of an implantable medical device. At operation 406, application 860 executing on recipient computing device 220 instructs the user to position the device 220 in the vicinity of recipient’s skin flap or skin area covering the implanted medical device. Application 860 can, in some examples discussed herein, read a sensor such as a Hall sensor to measure the proximity of device 220 to a magnet in the implantable part 104 of the implantable medical device, and when it senses the magnetic field of a specified strength, provide a vibration and / or noise or other visual or audio notification to the user that the external device 220 is aligned over the implantable medical device and that measurement is beginning. At operation 408, recipient computing device 220 emits light beams using the one or more of the device’s light sources (e.g., LED flash light) at the recipient’s skin surface. At operation 408, auditory prosthesis 210 also receives the reflected light beams at the light detector and transmits them to an application (e.g., application 860) as needed on recipient computing device 220 until sufficient data is gathered to complete the measurement. At operation 410, the light absorption patterns of the emitted and reflected light beams are analyzed to determine one or more oxygen saturation values. At operation 412, the one or more oxygen saturation values are compared with previous oxygen saturation measurements of the recipient and / or other. In one example, the oxygen saturation values can be compared using a machine learning model to determine if a decrease or absence of blood flow is detected in the scanned skin region and / or tissue of the recipient at operation 414.

[0057] An artificial intelligence, deep learning, and / or machine learning model can be constructed in some examples by extracting features from blood flow measurement and other relevant data of a plurality of recipients having known necrosis risk of various levels and / or known healthy tissue of various levels. In some examples, principal component analysis can be conducted using software programs known in the art (e.g., Python, SPSS version 24 or other versions, or other similar statistical software programs known to those skilled in the art) on extracted features to reduce feature dimensions as needed. In some examples, eigenvectors produced after the principal component analysis is performed can be input into a machine learning algorithm to generate a machine learning model. In one example, a machine learningalgorithm comprises a multilayer perceptron machine learning algorithm using software programs known in the art (e.g., Python Tensorflow library, Scikit-learn library, SPSS version 24 or other versions, or other statistical software programs known to those skilled in the art), although other machine learning algorithms known in the art can also be used. This machine learning algorithm can then be trained using the above sample set, which can then be randomly divided to create a training set, a testing set, and a validation set. In other examples, an artificial intelligence and / or deep learning model can be constructed and trained using large sets of structured or unstructured data, such as text, numerical data, images, video, and audio to determine whether a decrease or absence of blood flow is detected in the scanned skin region and / or tissue of the recipient, and / or whether the skin region and / or tissue of the recipient appears healthy or necrotic, and / or the level of necrosis, if any.

[0058] If the blood flow and / or tissue health looks healthy, and / or good and no adverse changes are detected at operation 415, the positive results (e.g., no necrosis risk) can be reported to the recipient and the method will wait until the next testing time at operation 420. In some examples, the recipient’s clinician will set the application 860 to automatically notify the user to test the recipient’s tissue health at regular intervals, e.g., biweekly, weekly, daily, every 12 hours, etc. in order to detect changes in the blood flow and / or tissue health in the vicinity of the implantable medical device. However, if a change is detected in the blood flow of the recipient at operation 414 (e.g., a decrease or absence of blood flow is detected), the recipient’s clinician or other health care provider is notified at operation 416 before the method ends at 420.Example Computing System

[0059] FIG. 8 illustrates an example of a suitable computing system 800 with which one or more of the disclosed examples can be implemented. Computing systems, environments, or configurations that can be suitable for use with examples described herein include, but are not limited to, personal computers, server computers, hand-held devices, laptop devices, multiprocessor systems, microprocessor-based systems, programmable consumer electronics (e.g., smart phones), network PCs, minicomputers, mainframe computers, tablets, distributed computing environments that include any of the above systems or devices, and the like. The computing system 800 can be a single virtual or physical device operating in a networkedenvironment over communication links through network 202 to one or more remote devices. The remote device can be an auditory prosthesis (e.g., the auditory prosthesis 110), a mobile device, a smart watch, a smart phone, a tablet, a personal computer, a server, a router, a network personal computer, a peer device or other common network node. In examples, the recipient computing device 120, the clinician computing device 130, and the server 140 includes one or more components or variations of components of the computing system 800. Further, in some examples, the auditory prosthesis 110 includes one or more components of the computing system 800.

[0060] In its most basic configuration, computing system 800 includes at least one processing unit 802 and memory 804.

[0061] The processing unit 802 includes one or more hardware or software processors (e.g., Central Processing Units) that can obtain and execute instructions. The processing unit 802 can communicate with and control the performance of other components of the computing system 800.

[0062] The memory 804 is one or more software- or hardware -based computer-readable storage media operable to store information accessible by the processing unit 802. The memory 804 can store, among other things, instructions executable by the processing unit 802 to implement applications or cause performance of operations described herein, as well as other data. The memory 804 can be volatile memory (e.g., RAM), non-volatile memory (e.g., ROM), or combinations thereof. The memory 804 can include transitory memory or non-transitory memory. The memory 804 can also include one or more removable or non-removable storage devices or persistent storage devices. In examples, the memory 204 can include RAM, ROM, EEPROM (Electronically-Erasable Programmable Read-Only Memory), flash memory, optical disc storage, magnetic storage, solid state storage, or any other memory media usable to store information for later access. In examples, the memory 804 encompasses a modulated data signal (e.g., a signal that has one or more of its characteristics set or changed in such a manner as to encode information in the signal), such as a carrier wave or other transport mechanism and includes any information delivery media. By way of example, and not limitation, the memory804 can include wired media such as a wired network or direct-wired connection, and wireless media such as acoustic, RF, infrared and other wireless media or combinations thereof.

[0063] In the illustrated example, the system 800 further includes a network adapter 806, one or more input devices 808, and one or more output devices 810. The system 800 can include other components, such as a system bus, component interfaces, a graphics system, a power source (e.g., a battery), among other components.

[0064] The network adapter 806 is a component of the computing system 800 that provides network access. The network adapter 806 can provide wired or wireless network access and can support one or more of a variety of communication technologies and protocols, such as ETHERNET, cellular, BLUETOOTH, near-field communication, and RF (Radiofrequency), among others. The network adapter 806 can include one or more antennas and associated components configured for wireless communication according to one or more wireless communication technologies and protocols.

[0065] The one or more input devices 808 are devices over which the computing system 800 receives input from a user. The one or more input devices 808 can include physically actuatable user-interface elements (e.g., buttons, switches, or dials), touch screens, keyboards, mice, pens, and voice input devices, among other input devices.

[0066] The one or more output devices 810 are devices by which the computing system 800 is able to provide output to a user. The output devices 810 can include, displays, speakers, and printers, among other output devices.

[0067] Computer system 800 executes instruction code contained in a computer program product 860. Computer program product 860 comprises executable code in an electronically readable medium that may instruct one or more computers such as computer system 800 to perform processing that accomplishes the exemplary method steps performed by the embodiments referenced herein.

[0068] The electronically readable medium may be any non-transitory computer readable medium that stores information electronically and may be accessed locally or remotely, forexample via a network connection. In alternative embodiments, the medium may be transitory. The medium may include a plurality of geographically dispersed media each configured to store different parts of the executable code at different locations and / or at different times. The executable instruction code in an electronically readable medium directs the illustrated computer system 800 to carry out various exemplary tasks described herein. The executable code for directing the carrying out of tasks described herein would be typically realized in software. However, it will be appreciated by those skilled in the art, that computers or other electronic devices might utilize code realized in hardware to perform many or all the identified tasks without departing from the present invention. Those skilled in the art will understand that many variations on executable code may be found that implement exemplary methods within the the scope of the present invention.

[0069] In some examples, the code or a copy of the code contained in computer program product 860 resides in one or more persistent storage media or devices (not separately shown) communicatively coupled to system 800 for loading and storage in a persistent storage device and / or memory 804 for execution by processor 802. Network adapter 806, input devices 808, output devices 810, processor 802, memory 804, and persistent storage devices are directly or indirectly coupled via a bus (not shown). Like any other persistent storage that might contain computer program product 860, memory 804 is a non-transitory media (even if implemented as a typical volatile computer memory device). Moreover, those skilled in the art will appreciate that in addition to storing computer program product 860 for carrying out processing described herein, memory 804 and / or any similar persistent storage device can be configured to store the various data elements referenced and illustrated herein.

[0070] Those skilled in the art will appreciate computer system 800 illustrates just one example of a system in which a computer program product in accordance with an embodiment of the present invention may be implemented. To cite but one example of an alternative embodiment, execution of instructions contained in a computer program product in accordance with an embodiment of the present invention may be distributed over multiple computers, such as, for example, over the computers of a distributed computing network.

[0071] Instructions for implementing a machine assisted method for evaluating tissue health and implementing any of the above in accordance with disclosed examples may reside in computer program product 860. When processor 802 is executing the instructions of computer program product 860, the instructions, or a portion thereof, are typically loaded into working memory 804 from which the instructions are readily accessed by processor 802.

[0072] In one embodiment, processor 802 in fact comprises multiple processors which may comprise additional working memories (additional processors and memories not individually illustrated) including one or more graphics processing units (GPUs) comprising at least thousands of arithmetic logic units supporting parallel computations on a large scale. Other embodiments comprise one or more specialized processing units comprising systolic arrays and / or other hardware arrangements that support efficient parallel processing. In some embodiments, such specialized hardware works in conjunction with a CPU and / or GPU to carry out the various processing described herein. In some embodiments, such specialized hardware comprises application specific integrated circuits and the like (which may refer to a portion of an integrated circuit that is application-specific), field programmable gate arrays and the like, or combinations thereof. In some embodiments, however, a processor such as processor 402 may be implemented as one or more general purpose processors (preferably having multiple cores) without necessarily departing from the scope of the present invention.

[0073] It should be apparent to those skilled in the art that many more modifications besides those already described are possible without departing from the inventive concepts herein. The inventive subject matter, therefore, is not to be restricted except as set forth in the appended claims. Moreover, in interpreting both the specification and the claim, all terms should be interpreted in the broadest possible manner consistent with the context. In particular, the terms “comprise” and “comprising” should be interpreted as referring to elements, compounds, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced. Where the specification or claims refer to at least one of something selected from the group consisting of A, B, C, ... and N, the text should be interpreted as requiring only one element from the group, not A plus N, or B plus N, etc.

[0074] In some embodiments, the numbers expressing quantities of ingredients, properties such as concentration, reaction conditions, and so forth, used to describe and claim certain embodiments of the invention are to be understood as being modified in some instances by the term “about.” Accordingly, in some embodiments, the numerical parameters set forth in the written description and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable. The numerical values presented in some embodiments of the invention may contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements.

[0075] Unless the context dictates the contrary, all ranges set forth herein should be interpreted as being inclusive of their endpoints and open-ended ranges should be interpreted to include only commercially practical values. Similarly, all lists of values should be considered as inclusive of intermediate values unless the context indicates the contrary.

[0076] As used in the description herein and throughout the claims that follow, the meaning of “a,” “an,” and “the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise.

[0077] The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specificationshould be construed as indicating any non-claimed element essential to the practice of the invention.

[0078] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and / or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims.

[0079] It should be noted that any language directed to a computer should be read to include any suitable combination of computing devices, including servers, interfaces, systems, databases, agents, peers, engines, controllers, or other types of computing devices operating individually or collectively. One should appreciate the computing devices comprise a processor configured to execute software instructions stored on a tangible, non-transitory computer readable storage medium (e.g., hard drive, solid state drive, RAM, flash, ROM, PLA, PLD, FPGA, etc.). The software instructions preferably configure or program the computing device to provide the roles, responsibilities, or other functionality as discussed below with respect to the disclosed apparatus. Further, the disclosed technologies can be embodied as a computer program product that includes a non-transitory computer readable medium storing the software instructions that causes a processor to execute the disclosed steps. In especially preferred embodiments, the various servers, systems, databases, or interfaces exchange data using standardized protocols or algorithms, possibly based on HTTP, HTTPS, AES, public-private key exchanges, web service APIs, or other electronic information exchanging methods. Data exchanges preferably are conducted over a packet-switched network, the Internet, FAN, WAN, VPN, or other type of packet switched network; a circuit switched network; cell switched network, or other type of network.

[0080] The following discussion provides many example embodiments of the inventive subject matter. Although each embodiment represents a single combination of inventive elements, the inventive subject matter is considered to include all possible combinations of thedisclosed elements. Thus, if one embodiment comprises elements A, B, and C, and a second embodiment comprises elements B and D, then the inventive subject matter is also considered to include other remaining combinations of A, B, C, or D, even if not explicitly disclosed.

[0081] As used in the description herein and throughout the claims that follow, when a system, engine, module, device, server, or other computing element is described as configured to perform or execute functions on data in a memory, the meaning of “configured to” or “programmed to” is defined as one or more processors or cores of the computing element being programmed by a set of software instructions stored in the memory of the computing element to execute the set of functions on target data or data objects stored in the memory thereby forming a structure having a specific purpose.

[0082] As used herein, and unless the context dictates otherwise, the term "coupled to" is intended to include both direct coupling (in which two elements that are coupled to each other contact each other) and indirect coupling (in which at least one additional element is located between the two elements). Therefore, the terms "coupled to" and "coupled with" are used synonymously.

[0083] While the invention has been particularly described with respect to the illustrated embodiments and examples discussed herein, it will be appreciated that various alterations, modification, and adaptations may be made based on the present disclosure and are intended to be within the scope of the invention. While the invention has been described in connection with what are presently considered to be some practical and / or preferred embodiments, it is to be understood that the invention is not limited to any of the disclosed embodiments or examples but only by the following claims.

Claims

CLAIMSWhat is claimed is:

1. A medical device implantable in a recipient, the medical device comprising: an implantable portion; an external portion comprising a light source and a light detector, wherein the light source is configured to transmit a plurality of light beams in a vicinity of the implantable portion, and wherein the light detector is configured for receiving a plurality of reflected light beams from the vicinity of the implantable portion; and at least one processor associated with the external portion and the implantable portion, wherein the at least one processor is configured to determine an oxygen saturation value at least in part based on the one or more intensity measurements received from the light sensor.

2. The implantable medical device of claim 1 , wherein the light source comprises a light emitting diode (LED).

3. The implantable medical device of any of claims 1 or 2, wherein the light detector comprises an optoelectronic sensor.

4. The implantable medical device of any of claims 1 through 3, wherein the implantable portion comprises a subcutaneously implanted magnet.

5. The implantable medical device of any of claims 1 through 4, wherein the implantable portion comprises a percutaneously implanted abutment.

6. The implantable medical device of any of claims 1 through 5, wherein the at least one processor is configured to determine whether the recipient is experiencing a decreased blood flow state based on the at least one oxygen saturation value.

7. A method for evaluating tissue health of a recipient comprising: receiving a measuring command at a sensor comprising at least one light emitting diode (LED) and a light detector; emitting one or more light beams from the at least one LED in a direction of a medical device wherein the medical device is implanted in the recipient; receiving one or more reflected light beams at the light detector; and determining an oxygen saturation value based at least in part on an intensity measurement of the reflected light beams from the light detector.

8. The method of claim 7, wherein the sensor comprises an optoelectronic sensor.

9. The method of claim 7, wherein the medical device is implanted subcutaneously in the recipient.

10. The method of claim 7, further comprising: determining whether the recipient is experiencing a decreased blood flow state based on the at least one oxygen saturation value.

11. The method of claim 10, further comprising: if the recipient is experiencing the decreased blood flow state, transmitting a warning notification to at least one clinician.

12. The method of claim 10, wherein determining whether the recipient is experiencing the decreased blood flow state based on the at least one oxygen saturation value is based on a machine learning model.

13. The method of claim 7, wherein the sensor is included in a device further comprising a sound processor and at least one magnet that is operable to couple with at least one magnet of the subcutaneously implanted medical device.

14. A system for evaluating tissue health of a recipient comprising: a medical device comprising at least one magnet wherein the medical device is implanted subcutaneously in the recipient; an optoelectronic sensor comprising at least one light emitting diode (LED) and a light detector; and at least one processor coupled to the optoelectronic sensor and configured to: receive a measuring command from a remote device; instruct the at least one LED to emit one or more light beams from the at least one LED in the direction of the subcutaneously implanted medical device; record at least one intensity measurement for one or more reflected light beams received at the light detector; and determine an oxygen saturation value based at least in part on the intensity measurement of the one or more reflected light beams from the light detector.

15. The system of claim 14, wherein the at least one processor is further configured to: determine whether the recipient is experiencing a decreased blood flow state based on the at least one oxygen saturation value.

16. The system of claim 15, wherein the at least one processor is further configured to: transmit a warning notification to at least one clinician if the recipient is experiencing the decreased blood flow state.

17. The system of claim 15, wherein the at least one processor is further configured to: determine whether the recipient is experiencing a decreased blood flow state based on the at least one oxygen saturation value using a machine learning model.

18. The system of any of claims 14 through 17, further comprising: a sound processor; at least one sound processor magnet configured to couple with the at least one magnet of the subcutaneously implanted medical device; and a sound processor housing enclosing the optoelectronic sensor, the sound processor, the at least one processor coupled to the optoelectronic sensor, and the at least one sound processor magnet.

19. The system of any of claims 14 through 17, wherein the at least one LED of the optoelectronic sensor comprises a LED flash light of a mobile device, the at least one processor comprises a processor of the mobile device, and the light detector comprises a camera of the mobile device.

20. The system of claim 19, wherein the at least one processor is further configured to: sense the at least one magnet of the subcutaneously implanted medical device using a magnetic field sensor of the mobile device when the recipient or a user places the smart phone adjacent to an area of the recipient body where the medical device is subcutaneously implanted; upon sensing the at least one magnet, automatically instruct the at least one LED to emit the one or more light beams from the at least one LED in the direction of the subcutaneously implanted medical device; upon sensing the at least one magnet, automatically store one or more intensity measurements for one or more reflected light beams received at the light detector; and emit one or more audio or visual alerts using the mobile device to alert the recipient or user to hold the mobile device over the area of the recipient body where the medical device is subcutaneously implanted, while the at least one LED is emitting one or more light beams and the light detector is receiving one or more reflected light beams, until a valid measurement signal is received.

21. The system of claim 20, wherein the at least one processor is further configured to:display a warning notification to a user if the recipient is determined to be experiencing the decreased blood flow state based on the at least one oxygen saturation value.

22. The system of claim 21, wherein the user is a health care provider of the recipient.

23. The system of claim 21, wherein the user is the recipient and the warning notification is displayed on the mobile device.

24. A non-transitory computer-readable medium including computer-readable code which, when executed by one or more processors operably connected to a sensor comprising at least one light emitting diode (LED) and a light detector, causes the one or more processors to: receive a blood flow measuring command from a remote device; emit one or more light beams from the at least one LED of the sensor toward a skin surface of a recipient that is adjacent to a medical device implanted percutaneously in the recipient, the medical device comprising at least one abutment and at least one implant configured to be operably connected to the at least one abutment; receive at least one intensity measurement of one or more reflected light beams striking a light detector of the optoelectronic sensor; and determine at least one oxygen saturation value based at least in part on the at least one intensity measurement of the one or more reflected light beams from the light detector.

25. The computer-readable medium of claim 24, wherein the one or more processors are configured to determine whether the recipient is experiencing a decreased blood flow state based on the at least one oxygen saturation value.

26. The computer-readable medium of claim 25, wherein the one or more processors are further configured to transmit a warning notification to at least one clinician if the recipient is experiencing the decreased blood flow state.

27. The computer-readable medium of claim 25, wherein the one or more processors are further configured to determine whether the recipient is experiencing the decreased blood flow state based on the at least one oxygen saturation value based on a machine learning model.

28. The computer-readable medium of claim 24, wherein the sensor comprises an optoelectronic sensor included in a device further comprising a sound processor and a member that is configured to connect with the at least one abutment of the percutaneously implanted medical device.

29. The computer-readable medium of any of claims 24 through 28, wherein the one or more processors are further configured to measure the blood flow of the recipient at a regular time interval.

30. The computer-readable medium of claim 29, wherein the regular time interval is adjustable by a clinician accessing a user interface running on a remote device.

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