Sterilizable surgical processing device

Abstract

Presented herein are sterilizable surgical processing devices, sometimes referred to herein as "sterilizable surgical processors." A sterilizable surgical processor is a device that is configured to be used during a surgical procedure to, for example, communicate with an implantable component (implant) being implanted in a recipient. The sterilizable surgical processor is further configured to undergo a sterilization process (e.g., using an autoclave process or other disinfection process) such that it can be re-used during multiple surgical procedures.

Description

STERILIZABLE SURGICAL PROCESSING DEVICEBACKGROUNDField of the Invention[oooi] The present invention relates generally to a sterilizable surgical processing device.Related Art

[0002] The continued expansion of digital technologies has led to enormous growth in the types / variety of electronic devices / systems available to users. Electronic devices include, for example, consumer electronic devices (e.g., mobile devices, wearables, computing devices, televisions, appliance s / white goods, etc.), medical devices, diagnostic equipment, among others. A number of electronic devices have been developed such that the devices can be carried by, worn by, or implanted in, the user.

[0003] For example, medical devices have provided a wide range of therapeutic benefits to users over recent decades. Certain medical devices can include internal or implantable components / devices, external or wearable components / devices, or combinations thereof (e.g., a device having an external component communicating with an implantable component). Medical devices, such as hearing devices (e.g., hearing aids, bone conduction devices, middle ear auditory prostheses, bone conduction devices, direct acoustic stimulators, cochlear implants, etc.), vestibular devices (e.g., vestibular implants), visual devices (i.e., bionic eyes), pacemakers, defibrillators, functional electrical stimulation devices, and other medical devices, have been successful in performing lifesaving, lifestyle enhancement, and / or monitoring functions.

[0004] The types of medical devices and the ranges of functions performed thereby have increased over the years. For example, some medical devices, sometimes referred to as “implantable medical devices,” now often include one or more instruments, apparatus, sensors, processors, controllers or other functional mechanical or electrical components that are permanently or temporarily implanted in a user. These functional devices are typically used to diagnose, prevent, monitor, treat, or manage a disease / injury or symptom thereof, or to investigate, replace or modify the anatomy or a physiological process. Many of these functional devices utilize power and / or data received from external devices that are part of, or operate in conjunction with, implantable components.SUMMARY

[0005] In one aspect, an apparatus is provided. The apparatus comprises: at least one hermetically-sealed housing; at least one processing unit disposed in the at least one hermetically-sealed housing; at least one inductive coil disposed in the at least one hermetically-sealed housing; a radio frequency (RF) transceiver disposed in the at least one hermetically-sealed housing and connected with the at least one processing unit and the at least one inductive coil, wherein the RF transceiver is configured to communicate with an implantable medical device configured to be implanted in a recipient; and at least one rechargeable power source disposed in the at least one hermetically-sealed housing and configured to power the at least one processing unit, wherein the at least one hermetically- sealed housing is configured to prevent liquid, vapor, or foreign materials from entering the at least one hermetically-sealed housing.

[0006] In another aspect, a method is provided. The method comprises: inductively coupling a processor coil of a sterilizable surgical processor to an implantable coil of an implantable component that is configured to be implanted in a recipient; using the sterilizable surgical processor to communicate with the implantable component during a surgical procedure to implant the implantable component in the recipient; and sterilizing the sterilizable surgical processor after the surgical procedure.

[0007] In another aspect, a method is provided. The method comprises: placing a processing device within a sterile field during a surgical procedure; removing the processing device from the sterile field; and sterilizing the processing device after the surgical procedure.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Embodiments of the present invention are described herein in conjunction with the accompanying drawings, in which:

[0009] FIG. 1A is a schematic diagram illustrating a cochlear implant system with which aspects of the techniques presented herein can be implemented;[ooio] FIG. IB is a side view of a recipient wearing a sound processing unit of the cochlear implant system of FIG. 1A;[ooii] FIG. 1C is a schematic view of components of the cochlear implant system of FIG. 1 A;

[0012] FIG. 2 is a simplified block diagram of a system including an implantable device, a sterilizable surgical processor, and a computing device or mobile device in communication with the sterilizable surgical processor, according to an example embodiment;

[0013] FIG. 3 is a schematic diagram illustrating a sterilizable surgical processor and a sterilization device with which aspects of the techniques presented herein can be implemented;

[0014] FIG. 4A is a flowchart of a method related to use of a sterilizable surgical processor, in accordance with certain embodiments presented herein;

[0015] FIG. 4B is a flowchart of another method related to use of a sterilizable surgical processor, in accordance with certain embodiments presented herein; and

[0016] FIG. 5 is a simplified block diagram of a system including an implantable device, a sterilizable surgical processor, and a computing device or mobile device in communication with the sterilizable surgical processor, according to an example embodiment.DETAILED DESCRIPTION

[0017] Presented herein are sterilizable surgical processing devices, sometimes referred to herein as “sterilizable surgical processors.” A sterilizable surgical processor is a device that is configured to be used during a surgical procedure to, for example, communicate with an implantable component (implant) being implanted in a recipient. The sterilizable surgical processor is further configured to undergo a sterilization process (e.g., using an autoclave process or other disinfection process) such that it can be re-used during multiple surgical procedures.

[0018] There are a number of different types of electronic 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 electronic device in the form of a cochlear implant system. 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, including consumer electronic devices (e.g., mobile / wireless devices, wearables, computing devices, televisions, appliance s / white goods, Intemet-of-Things (loT) devices, audio equipment, etc.), computing systems (e.g., servers in data centers), various types of software systems, such as databases, machine learning and artificial intelligence systems, other medical devices, diagnostic equipment, etc. For example, the techniques presented herein could beused in or with hearing devices, various implantable medical devices, such as vestibular devices (e.g., vestibular implants), visual devices (i.e., bionic eyes), sensors, pacemakers, drug delivery systems, defibrillators, functional electrical stimulation devices, catheters, seizure devices (e.g., devices for monitoring and / or treating epileptic events), sleep apnea devices, electroporation devices, etc. In further embodiments, the techniques presented herein can be implemented with air purifiers or air sensors (e.g., automatically adjust depending on environment), hospital beds, identification (ID) badges / bands, or other hospital equipment or instruments, or the like.

[0019] As used herein, the term “hearing device” is to be broadly construed as any device that acts 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 device systems. Combinations or variations thereof, 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.

[0020] FIGs. 1A-1C illustrates an example cochlear implant system 102 with which aspects of the techniques presented herein can be implemented. The cochlear implant system 102 comprises an external component 104 that is configured to be directly or indirectly attached to the body of the user, and an intemal / implantable component 112 that is configured to be implanted in or worn on the head of the user. In the examples of FIGs. 1A-1C, the implantable component 112 is sometimes referred to as a “cochlear implant.” FIG. 1A illustrates the implantable component 112 (cochlear implant) implanted in the head 154 of a user, while FIG. IB is a schematic drawing of the external component 104 worn on the head 154 of the user. FIG. 1C is another schematic view of the cochlear implant system 102. For ease of description, FIGs. 1A-1C will generally be described together.

[0021] In the examples of FIGs. 1A-1C, the external component 104 comprises a sound processing unit 106, an external coil 108, and generally, a magnet fixed relative to the external coil 108. The implantable component 112 (cochlear implant) includes an implantable coil 114,an implant body 134, and an elongate stimulating assembly 116 configured to be implanted in the user’s cochlea. In one example, the sound processing unit 106 is an off-the-ear (OTE) sound processing unit, sometimes referred to herein as an OTE component, that is configured to send data and power to the implantable component 112. In general, an OTE sound processing unit is a component having a generally cylindrically shaped housing 111 and which is configured to be magnetically coupled to the user’s head 154 (e.g., includes an integrated external magnet 150 configured to be magnetically coupled to an intemal / implantable magnet 152 in the implantable component 112). The OTE sound processing unit 106 also includes an integrated external (headpiece) coil 108 (the external coil 108) that is configured to be inductively coupled to the implantable coil 114.

[0022] It is to be appreciated that the OTE sound processing unit 106 is merely illustrative of the external devices that could operate with implantable component 112. For example, in alternative examples, the external component 104 can comprise a behind-the-ear (BTE) sound processing unit configured to be attached to, and worn adjacent to, the recipient’s ear. In general, a BTE sound processing unit comprises a housing that is shaped to be worn on the outer ear of the user and is connected to the separate external coil assembly via a cable, where the external coil assembly is configured to be magnetically and inductively coupled to the implantable coil 114. It is also to be appreciated that alternative external components could be located in the user’s ear canal, worn on the body, etc.

[0023] In FIGs. 1A and 1C, the cochlear implant system 102 is shown with an external device 110, configured to implement aspects of the techniques presented. The external device 110 is a computing device, such as a personal computer (e.g., laptop, desktop, tablet), a mobile phone (e.g,, smartphone), remote control unit, etc. The external device 110 and the cochlear implant system 102 (e.g., sound processing unit 106 or the implantable component 112) wirelessly communicate via a bi-directional communication link 126. The bi-directional communication link 126 can comprise, for example, a short-range communication, such as Bluetooth link, Bluetooth Low Energy (BLE) link, a proprietary link, etc.

[0024] As noted, presented herein are techniques for providing a sterilizable surgical processing device (sterilizable surgical processor), including but not limited to a sterilizable cochlear implant surgical processor, that is designed to be used during implant surgery to communicate with an implantable component (implant). A feature of the sterilizable surgical processor is that it is configured to be re-usable after sterilization (e.g., the sterilizable surgical processor is configured to undergo a sterilization process using, for example, an autoclaveprocess or other disinfection process). For ease of description, the sterilizable surgical processors will be described with reference to cochlear implants, but it is to be appreciated that the sterilizable surgical processors could be used to implant other types of implantable components / devices.

[0025] In the current surgical environment for implantation, a sound processor is placed inside a sterile bag and coupled to the implantable component to, for example, perform intra-operative measurements. The sound processor itself is not a sterile device and is placed outside of the sterile field (on top of surgical draping). For example, in certain examples, the surgical draping may be approximately 5-6 mm thick, and thus when combined with skin swelling, the overall implantable coil to sound processor coil separation can be up to approximately 16mm (although it is noted that some devices may be able to communicate over distances larger than 16mm).

[0026] The relatively large separation between the implantable coil and the sound processor coil poses a number of challenges during surgery. For example, it is difficult to co-locate the sound processor coil and the implantable coil to ensure stable communication, as the attraction force between the magnets is very weak. Even once the correct position has been determined, the magnets may not retain the sound processor coil in the correct position. Surgical support staff typically will use tape to try and fix the sound processor (and thus sound processor coil) in the correct position. The relatively large separation between the implantable coil and the sound processor also makes it difficult to provide sufficient power to the implant required for interoperative measurements, such as impedance measurements, Neural Response Telemetry (NRT) measurements, electro-audiometry (EAM) measurements, electrically-evoked stapedial reflex threshold (eSRT) measurements, electrocochleography (EcochG) measurements, etc., (or some combination thereof). The difficulty with alignment and reliable communication between the sound processor and the implantable coil, in conventional arrangements, is even more challenging for recipients with high skin-flap thickness.

[0027] Currently, the existing sound processors used during implant surgery are not suitable for medical-grade sterilization in, for example, an autoclave, because they are damaged at high temperatures and / or when exposed to moisture or vapor. Inclusion of integrated microphones, lack of integrated batteries, lack of heat-rated components, and presence of physical ports / connectors for charging and / or data communications can also preclude autoclave sterilization of the existing sound processors or conventional surgical processors.

[0028] In order to address these difficulties, a surgical processor which can be sterilized is provided according to an aspect of the present disclosure. In certain embodiments, the sterilizable surgical processor is configured to be sterilized in an autoclave (e.g., a high- temperature and high-pressure cleansing apparatus). Providing a surgical processor which can be sterilized in an autoclave, meaning that the sterilizable surgical processor can be exposed to high temperatures, vapor, and moisture without incurring damage thereto, can provide any of a number of advantages over conventional arrangements. For example, a sterilizable surgical processor allows for the removal of the sterile bag from the surgical setup, and allows for the surgical processor to be placed inside the sterile field (i.e., beneath the surgical drapes), thereby reducing the coil-to-coil distance (i.e., the separation between the implantable coil and the surgical processor coil) during interoperative measurements. Although some example embodiments describe an autoclave process, other sterilization processes can also be used, such as a liquid disinfection process and / or a gas disinfection process.

[0029] In one example embodiment, the surgical processor can comprise an “off-the-ear” or “over-the-ear” (OTE) device (e.g., refer to FIG. 2). However, example embodiments are not limited thereto, and the various hardware features and functional aspects described herein can also be adapted and applied for a “behind-the-ear” (BTE) device (e.g., refer to FIG. 5), an “in- the-ear” (ITE) device, or other form factors. Some modifications to an existing BTE device can be needed to ensure that the entire device (main body with surgical processing circuitry and battery, plus the external coil / surgical processor coil and connection thereto) remains hermetically sealed, such as by providing a hermetic feedthrough and / or sealing the connection point where the external coil / surgical processor coil cable typically plugs into a sound processor. Another consideration for both OTE devices and BTE devices may relate to a magnet attachment being fixed and flush (e.g., to avoid bacteria biofilm). To provide a surgical processor that is sterilizable, the magnet should be integrated into the housing of the device.

[0030] To be suitable for autoclave sterilization, such processing devices need to be able to withstand the high temperature (e.g., approximately 130 degrees C) and moisture of the autoclave process. According to an aspect of the present disclosure, this tolerance to high heat can be achieved using a dedicated surgical processor which is hermetically sealed. Providing a hermetically-sealed surgical processor would also enable other suitable sterilization techniques to be utilized, such as a liquid disinfection process and / or a gas disinfection process, among others.

[0031] In general, various materials are suitable for use as the housing for a sterilizable surgical processor and providing a hermetic seal, including but not limited to plastics, polymers, metals or metal oxides, semiconductors, ceramics, epoxy resins, glass, or rubber materials, for example. However, some of the materials can be unsuitable or less suitable for purposes of hermetically sealing a surgical processor. Preferably, if the sterilization method is with elevated temperature, certain medical-grade plastic materials can be used in some example embodiments (e.g., polyether ether ketone (PEEK), polyphenylsulfone (PPSU), polyetherimide (PEI), etc., which are all high-performance and heat-resistant thermoplastic polymer materials). These materials can be suitable for a number of sterilizations, with the number of sterilizations depending on the details of the sterilization process. Alternatively, ceramic injection molding can be used for housing components of the surgical processor, or two halves of ceramic material can be sealed together (although joining methods and sealing can be more complicated for ceramics compared to medical -grade plastic materials). It is also possible that some combination of different materials could also be used (e.g., partially thermoplastic / polymer material near the coils / antennae, and partially metal on other parts of the device where interference is less of a concern).

[0032] In addition, in certain embodiments, an integrated battery is provided in the sterilizable surgical processor that can withstand the high temperature of the autoclave process. For example, a high temperature rated lithium-ion (Li-Ion) battery can be used for this purpose, although batteries with other suitable chemistries may also be used (as long as they are similarly rated for high temperature operation). Preferably, the integrated battery should be rated for temperatures up to about 145-150 degrees C (e.g., for purposes of an autoclave sterilization process). The integrated battery can be inductively charged, for example, which eliminates the need for a physical connector.

[0033] The sterilizable surgical processor includes a wireless transceiver (and a corresponding antenna) that is configured to provide a wireless link (e.g., 2.4Ghz) for communicating data to surgical software. This wireless link also enables the sterilizable surgical processor to be programmed wirelessly using an external computing device.

[0034] Typically, the microphone of an existing sound processor is not used during intraoperative measurements. Thus, the sterilizable surgical processor described herein does not need to include a microphone (and further, does not need to include any microphone holes to expose the microphone to permit sound penetration / capture).

[0035] Status indications of the surgical processor can be provided through the surgical software. Thus, the sterilizable surgical processor described herein does not need to include any external ports or openings for indicator lights / LEDs (which could otherwise potentially introduce a fluid ingress point). In some examples, there could still be LEDs or other visual indicators present internally within the hermetically sealed housing of the device (e.g., in a variation where at least a portion of the housing is made transparent, so as to allow light to penetrate outward).

[0036] In some examples, a tap interface (optional) can be provided for powering the sterilizable surgical processor on and off and / or various other functional controls. Alternatively, a software interface (e.g., through the surgical software executing on an external computing device or mobile device) can be provided to control one or more functional operations (e.g., the power on / off function) of the sterilizable surgical processor. Other possible alternatives for controlling power and / or other functions of the sterilizable surgical processor may include movement detection (e.g., via an inertial measurement unit (IMU), accelerometer, gyroscope, or other motion sensor), a capacitive touch button, or operating in a low power state (e.g., by default) and switching to a high power state upon detection of the implant or detection of a wireless connection with another external device, for example.

[0037] FIG. 2 depicts a simplified block diagram of a system 200 according to an example embodiment. As shown in FIG. 2, the system 200 includes an implantable component / device 212 and a sterilizable surgical processor 206. The implantable device 212 includes a Radio Frequency (RF) transceiver 240 and a stimulator unit 242 connected with a subcutaneous stimulating assembly 246. The sterilizable surgical processor 206 includes an RF transceiver 222, a processor 231, and a memory 233. The system 200 can also include an external computing device 210 (e.g., a tablet, a mobile device, etc.) configured to wirelessly communicate with the surgical processor 206.

[0038] The implantable device 212 can be a cochlear implant, for example, and can include a sensor 255 that is configured to perform intraoperative measurements, including but not limited to impedance measurements, Neural Response Telemetry (NRT) measurements, electroaudiometry (EAM) measurements, electrically-evoked stapedial reflex threshold (eSRT) measurements, electrocochleography (EcochG) measurements, etc., (or some combination thereof) from a recipient of the implantable device 212 via the stimulator unit 242 and the subcutaneous stimulating assembly 246, and to transmit the intraoperative measurements viathe RF transceiver 240. The implantable device 212 also includes a processor 258, an intemal / implantable coil 214, and an intemal / implantable magnet 252 integrated therein.

[0039] According to example embodiments described herein, the sterilizable surgical processor 206 is configured to receive the intraoperative measurements from the implantable device 212 via the RF transceiver 222 and to analyze the intraoperative measurements obtained from the recipient using the processor 231. In addition, the sterilizable surgical processor 206 can be configured to store the intraoperative measurements in the memory 233. The sterilizable surgical processor 206 includes an external coil 208 (sometimes referred to as a surgical processor coil) and an external magnet 250 integrated therein, where the external coil 208 of can be inductively coupled with the implantable coil 214 of the implantable device 212, for example.

[0040] Since the sterilizable surgical processor 206 can be sterilized before use, the sterilizable surgical processor 206 can be located inside the sterile field (e.g., under surgical draping), thereby reducing the coil-to-coil distance (i.e., the separation between the implantable coil 214 and the surgical processor coil 208) during interoperative measurements. As a result, the sterilizable surgical processor 206 can be more readily inductively coupled with the implantable device 212 over the RF link 248. During a surgical process, the external magnet 250 of the sterilizable surgical processor 206 can be magnetically coupled with the internal magnet 252 of the implantable device 212.

[0041] In some example embodiments, the sterilizable surgical processor 206 can optionally include a tap interface 228 to control one or more functional operations of the device, including but not limited to powering the device on and off, among other controls. Alternatively, the tap interface 228 can be omitted, and a software interface can be used to control functional operations and / or power cycling of the sterilizable surgical processor 206 via the external computing device 210 (e.g., a tablet, a mobile device, etc.).

[0042] Conventional processing devices, such as sound processors, are not hermetically-sealed and have components that are not able to withstand heat and exposure to moisture, and are therefore unsuitable for autoclave -sterilization and re-use. To address these disadvantages and provide an improved device, the sterilizable surgical processor 206 includes a rechargeable power source 232, which is a high-temperature rated lithium-ion (Li-Ion) battery according to one non-limiting example embodiment, with inductive charging capability via a charging coil 230. In addition, the various components of the sterilizable surgical processor 206 arecontained within a housing 211, which is hermetically-sealed and formed of a suitable high- performance material (e.g., medical-grade plastics, thermoplastics, polymers, etc.) capable of withstanding high temperature, moisture and vapor, and preferably impact resistance.

[0043] In some example embodiments, the processor 231 of the sterilizable surgical processor 206 is configured to analyze the intraoperative measurements obtained from the recipient to diagnose a medical condition and / or to predict or characterize a medical event. In some example embodiments, the processor 231 of the sterilizable surgical processor 206 (and / or the processor 258 of the implantable device 212) is further configured to control the stimulator unit 242 of the implantable device 212 to adjust stimulation provided to the recipient via the subcutaneous stimulating assembly 246 based on an analysis of the intraoperative measurements.

[0044] In some example embodiments, the sterilizable surgical processor 206 can include a wireless transceiver 220, and can be in communication with the external computing device 210 (e.g., a laptop / PC, a tablet, a mobile device, a smartphone, etc.). The external computing device 210 includes a wireless transceiver 286 configured to, in certain examples, receive the intraoperative measurements obtained from the recipient from the sterilizable surgical processor 206. The external computing device 210 can also include aprocessor 283 configured to analyze the intraoperative measurements obtained from the recipient, and a memory 284 configured to store the intraoperative measurements. For example, the processor 283 can be configured to analyze the intraoperative measurements obtained from the recipient to diagnose a medical condition and / or to predict or characterize a medical event.

[0045] The processor 283 of the external computing device 210 can execute surgical software 295 stored in the memory 284 to implement various aspects of the techniques described herein, including but not limited to programming the sterilizable surgical processor 206 and / or the implantable device 212, device status checks, commands, controls, configurations, analysis, presenting graphical user interfaces (GUIs), and the like. The external computing device 210 (e.g., a tablet, a mobile device, etc.) can be wirelessly paired with the sterilizable surgical processor 206 via a wireless link 226, and can be configured to perform various operations, including but not limited to, data logging, data analysis, user notification, and / or complementary data collection using an inertial measurement unit (IMU), gyroscope, accelerometer, or other sensing means (not shown in FIG. 2) of the external computing device 210. The external computing device 210 can also include input devices 287 (e.g., keyboard, touchscreen, etc.) for receiving user input and output devices 288 (e.g., display screen,speakers, etc.) for providing user output, during execution of the surgical software 295 to implement the techniques described herein, for example.

[0046] Thus, an apparatus is provided according to an example embodiment (e.g., referring to the sterilizable surgical processor 206 of FIG. 2). The apparatus comprises: a hermetically- sealed housing; at least one processing unit disposed in the housing; at least one inductive coil disposed in the housing; a radio frequency (RF) transceiver disposed in the housing and connected with the at least one processing unit and the at least one inductive coil, wherein the RF transceiver is configured to communicate with an implantable medical device configured to be implanted in a recipient; and at least one rechargeable power source disposed in the hermetically-sealed housing and configured to power the at least one processing unit, wherein hermetically-sealed housing is configured to prevent liquid, vapor, or foreign materials from entering the housing.

[0047] In some examples, the at least one inductive coil is configured to be inductively coupled to a coil of the implantable medical device for use in capturing intraoperative measurements from the implantable medical device during a surgical procedure. In some examples, the housing has a smooth solid outer surface without any openings, grooves, or indentations. In some examples, the housing does not include any physical ports, connectors, or microphone holes. In some examples, the at least one rechargeable power source is configured to be inductively charged. In some examples, the apparatus further includes a wireless interface configured to provide a wireless link for communicating with an external computing device. In some examples, the wireless interface is further configured to receive instructions from the external computing device via the wireless link.

[0048] In some examples, the housing is sterilizable using a sterilization process (e.g., an autoclave process or other disinfection process) without damaging the at least one processing unit or the at least one rechargeable power source to enable the apparatus to be reused in a subsequent surgical procedure after the housing has been sterilized. In some examples, the at least one power source is a high temperature rated battery that is configured to withstand exposure to heat during the sterilization process. In some examples, the at least one rechargeable power source is a high temperature rated battery (e.g., lithium-ion (Li-Ion) or other suitable battery chemistry). In some examples, the apparatus further includes a tap interface for control of the apparatus. In some examples, the apparatus does not include any external ports or openings for buttons, switches, or light emitting diodes (LEDs). In some examples, there is no microphone disposed in or on the housing. In some examples, the housingis hermetically sealed using a heat-resistant material comprising at least one of a medical -grade plastic material, a thermoplastic material, a polymer material, or a ceramic material that can withstand high temperatures.

[0049] FIG. 3 is a schematic diagram illustrating a sterilizable surgical processor 206 and a sterilization device (e.g., autoclave) 370 with which aspects of the techniques presented herein can be implemented. Following use of the sterilizable surgical processor 206 described above with reference to FIG. 2 in a surgical procedure, the sterilizable surgical processor 206 is deemed to be in a “non-sterile” state (e.g., a “non-sterile” sterilizable surgical processor 206). As such, to facilitate re-use of the sterilizable surgical processor 206 in a subsequent surgical procedure, the non-sterile sterilizable surgical processor 206 can be placed in a sterilization device 370, such as an autoclave, as shown in FIG. 3. The sterilization device 370 can then be operated to perform a sterilization process that places the sterilizable surgical processor 206 into a “sterilized” state (e.g., a “sterile” sterilizable surgical processor 206).

[0050] The sterilization device 370 can take a number of different forms and, as a result, the sterilization process used to convert the sterilizable surgical processor 206 from the “non- sterile” state to the “sterile” state can also take a number of different forms. In certain examples, the sterilization device 370 is an autoclave and the sterilization process is a high- temperature and high-pressure cleansing process, sometimes referred to herein as an “the autoclave sterilization process,” that is performed while the sterilizable surgical processor 206 is inside the sterilization device 370. Upon completion of the autoclave sterilization process, the sterilized sterilizable surgical processor 206 will be removed from the sterilization device 370 and can then be reused in another surgical procedure.

[0051] At a basic level, the sterilization device 370 (e.g., an autoclave) can have one or more interfaces (e.g., buttons, dials, touchscreens, gauges, timers, indicators, lights, etc.), a door (e.g., with a window and sealing means), and components for securely closing and latching the unit (not shown in FIG. 3, for simplicity, although many different closing / latching mechanisms are suitable). Various autoclaves and / or other sterilization devices, as well as any future- developed medical-grade sterilization devices, can be used in connection with the sterilizable surgical processor 206 and corresponding techniques as described above and further below with reference to FIGs. 4A and 4B. That is, although FIG. 3 depicts an autoclave as the sterilization device 370, example embodiments are not limited to an autoclave process, and it should be appreciated that other sterilization devices and / or other sterilization processes (e.g.,a liquid disinfection process and / or a gas disinfection process) are also within the scope of the present disclosure.

[0052] In addition to being hermetically-sealed, having the high-temperature rated battery with inductive charging capability integrated therein, and having wireless communications capability with external computing devices and mobile devices, the sterilizable surgical processor 206 described herein is also suitable for autoclave sterilization (and / or other suitable disinfection processes) because, unlike existing processors, there are no microphones (and no sound holes), no external physical ports / connectors / interfaces, no external ports or openings for buttons / switches / LEDs, and preferably no indentations on the outer surface (e.g., nooks / crannies) to trap moisture or debris.

[0053] In some example embodiments, the integrated battery can be recharged after implant surgery is performed, but before sterilization of the surgical processor 206 is performed using the sterilization device 370. In some other example embodiments, the surgical processor 206 can be placed in a sterile bag after sterilization is performed using the sterilization device 370, to allow the (sterilized) surgical processor 206 to be handled (e.g., for charging purposes).

[0054] FIG. 4A is a flowchart of a method related to use of sterilizable surgical processor in accordance with certain embodiments presented herein. At operation 410, method 400 includes inductively coupling a processor coil of a sterilizable surgical processor to an implantable coil of an implantable component that is configured to be implanted in a recipient. At operation 420, method 400 includes using the sterilizable surgical processor to communicate with the implantable component during a surgical procedure to implant the implantable component in the recipient. At 430, method 400 includes sterilizing the surgical processor after the surgical procedure.

[0055] In some examples, the hermetically-sealed housing is configured to prevent the surgical processor and the power source from being exposed to liquid or vapor or foreign materials. In some examples, operation 420 includes receiving results of one or more objective measurements including one or more of impedance measurements, neural response telemetry (NRT) measurements, electro-audiometry (EAM) measurements, electrically-evoked stapedial reflex threshold (eSRT) measurements, electrocochleography (EcochG) measurements, or a combination thereof, and / or receiving results of one or more voltage measurements, one or more current measurements, one or more RF counter measurements, or a combination thereof.

[0056] In some examples, method 400 can further include communicating, via a wireless link provided by a wireless interface that is disposed in the hermetically-sealed housing, results of the one or more intraoperative measurements to an external computing device. In some examples, method 400 can further include communicating, via the wireless link, one or more status indications of the surgical processor to the external computing device. In some examples, method 400 can include inductively charging the power source within the hermetically-sealed housing.

[0057] In some examples, operation 430 can include placing the surgical processor in an autoclave after completion of the surgical procedure, and operating the autoclave to sterilize the hermetically-sealed housing using a high pressure and high temperature cleansing process. In some examples, the power source is a high temperature rated battery, and wherein the surgical processor is configured to withstand exposure to heat and moisture during sterilization using the autoclave. In some examples, method 400 can further include placing the surgical processor in a sterile bag after sterilization using the autoclave so that the hermetically-sealed housing can be handled, and the integrated power source can be inductively charged while remaining sterile. In some examples, operation 430 can include sterilizing the surgical processor using a liquid disinfection process, or using a gas disinfection process. In some examples, method 400 can further include reusing the surgical processor during a subsequent surgical procedure after sterilization.

[0058] FIG. 4B is a flowchart of a method 490 related to use of processing device in accordance with certain embodiments presented herein. At operation 492, method 490 includes placing a processing device within a sterile field during a surgical procedure. At operation 494, method 490 includes removing the processing device from the sterile field. At 496, method 490 includes sterilizing the processing device after the surgical procedure.

[0059] FIG. 5 depicts a simplified block diagram of a system 500 according to an example embodiment. As shown in FIG. 5, the system 500 includes an implantable device 512 and a sterilizable surgical processor 506. The system 500 can also include a computing device 510 (e.g., a tablet, a mobile device, etc.) configured to wirelessly communicate with the sterilizable surgical processor 506.

[0060] In system 500 of FIG. 5, like reference numerals refer to like components as described above with reference to system 200 of FIG. 2. As such, similar details are not repeated forFIG. 5 to focus on the differences in this example embodiment, which can relate to a behind- the-ear (BTE) device, specifically (instead of an OTE device).

[0061] As shown in FIG. 5, the external coil 508 (and external magnet 550) is not integrated within the hermetically-sealed housing 511 of the sterilizable surgical processor 506. Instead, the sterilizable surgical processor 506 comprises a main module 505 and a coil module 575 electrically connected by a cable 567. The main module 505 comprises a hermetically-sealed housing 511 in which various components, as described above with reference to FIG. 2, are disposed therein. The coil module 575 also includes a hermetically-sealed housing 577 having the external coil 508 and the external magnet 550 disposed therein. The external coil 508 is electrically connected to the RF transceiver 522 inside the housing 511 via a hermetically- sealed feedthrough 571(1) in the hermetically-sealed housing 577, the cable 567, and a hermetically-sealed feedthrough 571 (2) in the housing 511. In the arrangement of FIG. 5 , the ends 579(1) and 579(2) of the cable 567 are integrated with the housing 577 / hermetically- sealed feedthrough 571(1) in the coil module 575 and the housing 511 / hermetically-sealed feedthrough 571(2) in the main module 505, respectively, to maintain the hermetic integrity of the device.

[0062] In this example embodiment, the coil module 575 is not detachable or removable from the main module 505, so that the hermetic seal can be maintained (e.g., the coil module 575 and the main module 505 are separate and connected via hermetically-sealed feedthroughs such that the entire sterilizable surgical processor 506 can be sterilized for reuse according to the techniques described herein). Thus, an apparatus is provided according to another example embodiment (e.g., referring to the sterilizable surgical processor 506 including the main module 505 and the coil module 575 of FIG. 5).

[0063] As stated, there are several specific challenges that prevent existing sound processors from being sterilized in an autoclave (e.g., components of existing sound processors are not designed to withstand high temperatures and exposure to moisture). According certain embodiments described herein, a sterilizable surgical processor is provided to address these challenges by having at least the following features: (1) a hermetically-sealed housing, (2) an integrated high temperature rated battery with inductive charging capability, (3) a wireless interface (transceiver / antenna) to provide wireless communication capabilities (e.g., with surgical software executing on an external computing device), and (4) no external openings (e.g., no physical ports, plugs, connectors, gaps / cracks in or on the housing, etc.). This can avoid damage to components of the surgical processor due to high heat and prevent exposureof components to moisture or vapor during the autoclave sterilization process, as well as other disinfection processes (e.g., liquid, gas).

[0064] Thus, this unique combination of structural and functional features can render the surgical processor to be sterilizable using an autoclave (or other disinfection process), and does not require the surgical processor to be placed in sterile packaging or a disposal container (unlike the existing sound processors for surgical use). The sterilizable surgical processor described herein can also provide improved retention and reliability of the RF link during surgical use. Another advantage of the sterilizable surgical processor is to provide a superior user experience in positioning the coil during surgery. The sterilizable surgical processor enables use of an autoclave sterilization method that, in turn, allows the surgical processor to be re-used multiple times even if it was exposed to biological contamination.

[0065] As should be appreciated, while particular uses of the technology have been illustrated and discussed above, the disclosed technology can be used with a variety of devices in accordance with many examples of the technology. The above discussion is not meant to suggest that the disclosed technology is only suitable for implementation within systems akin to that illustrated in the figures. In general, additional configurations can be used to practice the processes and systems herein and / or some aspects described can be excluded without departing from the processes and systems disclosed herein.

[0066] This disclosure described some aspects of the present technology with reference to the accompanying drawings, in which only some of the possible aspects were shown. Other aspects can, however, be embodied in many different forms and should not be construed as limited to the aspects set forth herein. Rather, these aspects were provided so that this disclosure was thorough and complete and fully conveyed the scope of the possible aspects to those skilled in the art.

[0067] As should be appreciated, the various aspects (e.g., portions, components, etc.) described with respect to the figures herein are not intended to limit the systems and processes to the particular aspects described. Accordingly, additional configurations can be used to practice the methods and systems herein and / or some aspects described can be excluded without departing from the methods and systems disclosed herein.

[0068] According to certain aspects, systems and non-transitory computer readable storage media are provided. The systems are configured with hardware configured to execute operations analogous to the methods of the present disclosure. The one or more non-transitorycomputer readable storage media comprise instructions that, when executed by one or more processors, cause the one or more processors to execute operations analogous to the methods of the present disclosure.

[0069] Similarly, where steps of a process are disclosed, those steps are described for purposes of illustrating the present methods and systems and are not intended to limit the disclosure to a particular sequence of steps. For example, the steps can be performed in differing order, two or more steps can be performed concurrently, additional steps can be performed, and disclosed steps can be excluded without departing from the present disclosure. Further, the disclosed processes can be repeated.

[0070] Although specific aspects were described herein, the scope of the technology is not limited to those specific aspects. One skilled in the art will recognize other aspects or improvements that are within the scope of the present technology. Therefore, the specific structure, acts, or media are disclosed only as illustrative aspects. The scope of the technology is defined by the following claims and any equivalents therein.

[0071] It is also to be appreciated that the embodiments presented herein are not mutually exclusive and that the various embodiments can be combined with another in any of a number of different manners.

Claims

CLAIMSWhat is claimed is:

1. An apparatus comprising: at least one hermetically-sealed housing; at least one processing unit disposed in the at least one hermetically-sealed housing; at least one inductive coil disposed in the at least one hermetically-sealed housing; a radio frequency (RF) transceiver disposed in the at least one hermetically-sealed housing and connected with the at least one processing unit and the at least one inductive coil, wherein the RF transceiver is configured to communicate with an implantable medical device configured to be implanted in a recipient; and at least one rechargeable power source disposed in the at least one hermetically-sealed housing and configured to power the at least one processing unit, wherein the at least one hermetically-sealed housing is configured to prevent liquid, vapor, or foreign materials from entering the at least one hermetically-sealed housing.

2. The apparatus of claim 1, wherein the at least one inductive coil is configured to be inductively coupled to a coil of the implantable medical device for use in capturing intraoperative measurements from the implantable medical device during a surgical procedure.

3. The apparatus of claim 1 or 2, wherein the at least one hermetically-sealed housing has a substantially smooth solid outer surface without any openings, grooves, or indentations.

4. The apparatus of claim 1 or 2, wherein the at least one hermetically-sealed housing does not include any physical ports, connectors, or microphone holes.

5. The apparatus of claim 1 or 2, wherein the at least one rechargeable power source is configured to be inductively charged.

6. The apparatus of claim 1 or 2, further comprising:a wireless interface configured to provide a wireless link for communicating with an external computing device.

7. The apparatus of claim 6, wherein the wireless interface is further configured to: receive instructions from the external computing device via the wireless link.

8. The apparatus of claim 1 or 2, wherein the at least one hermetically-sealed housing is sterilizable using a sterilization process without damaging the at least one processing unit or the at least one rechargeable power source to enable the apparatus to be reused in a subsequent surgical procedure after the at least one hermetically-sealed housing has been sterilized.

9. The apparatus of claim 8, wherein the at least one rechargeable power source is a high temperature rated battery that is configured to withstand exposure to heat during the sterilization process.

10. The apparatus of claim 9, wherein the at least one rechargeable power source is a high temperature rated battery.

11. The apparatus of claim 1 or 2, further comprising: a tap interface for control of the apparatus.

12. The apparatus of claim 1 or 2, wherein the apparatus does not include any external ports or openings for buttons or switches, or light emitting diodes (LEDs).

13. The apparatus of claim 1 or 2, wherein there is no microphone disposed in or on the at least one hermetically-sealed housing.

14. The apparatus of claim 1 or 2, wherein the at least one hermetically-sealed housing is formed from a heat-resistant material comprising at least one of a medical-grade plastic material, a thermoplastic material, a polymer material, or a ceramic material that can withstand high temperatures.

15. The apparatus of claim 1 or 2, wherein the at least one hermetically-sealed housing comprises a first hermetically-sealed housing and a second hermetically-sealed housing.

16. The apparatus of claim 15, wherein the at least one processing unit, RF transceiver, and the at least one rechargeable power source are disposed in the first hermetically-sealed housing, and wherein the at least one inductive coil is disposed in the second hermetically- sealed housing.

17. The apparatus of claim 16, wherein the RF transceiver and the at least one inductive coil are electrically connected via a first hermetic feedthrough in the first hermetically-sealed housing, a cable, and a second hermetic feedthrough in the second hermetically-sealed housing.

18. The apparatus of claim 17, wherein a cable is not detachable or removable from either the first hermetically-sealed housing or the second hermetically-sealed housing.

19. The apparatus of claim 1 or 2, wherein the at least one hermetically-sealed housing comprises a single hermetically-sealed housing.

20. A method comprising: inductively coupling a processor coil of a sterilizable surgical processor to an implantable coil of an implantable component that is configured to be implanted in a recipient; using the sterilizable surgical processor to communicate with the implantable component during a surgical procedure to implant the implantable component in the recipient; and sterilizing the sterilizable surgical processor after the surgical procedure.

21. The method of claim 20, wherein after sterilizing the sterilizable surgical processor, the method further comprises: inductively coupling the processor coil of the sterilizable surgical processor to an implantable coil of a second implantable component to be implanted in a second recipient;and using the sterilizable surgical processor to communicate with the second implantable component during a surgical procedure to implant the second implantable component in the second recipient.

22. The method of claim 21, further comprising: sterilizing the sterilizable surgical processor after the surgical procedure to implant the second implantable component in the second recipient.

23. The method of claim 20, 21, or 22, wherein using the sterilizable surgical processor to communicate with the implantable component during the surgical procedure comprises: receiving, via the processor coil, results of one or more intraoperative measurements from the implantable component during the surgical procedure.

24. The method of claim 23, wherein receiving results of one or more intraoperative measurements from the implantable component during the surgical procedure comprises: receiving results of one or more objective measurements including one or more of impedance measurements, neural response telemetry (NRT) measurements, electroaudiometry (EAM) measurements, electrically-evoked stapedial reflex threshold (eSRT) measurements, electrocochleography (EcochG) measurements, or a combination thereof.

25. The method of claim 23, wherein receiving results of one or more intraoperative measurements from the implantable component during the surgical procedure comprises: receiving results of one or more voltage measurements, one or more current measurements, one or more RF counter measurements, or a combination thereof.

26. The method of claim 23, further comprising: communicating, via a wireless link provided by a wireless interface of the sterilizable surgical processor, results of the one or more intraoperative measurements to an external computing device.

27. The method of claim 20, 21, or 22, further comprising: communicating, via a wireless link provided by a wireless interface of the sterilizable surgical processor, one or more status indications of the sterilizable surgical processor to an external computing device.

28. The method of claim 20, 21, or 22, further comprising: after using the sterilizable surgical processor to communicate with the implantable component during the surgical procedure, inductively charging a rechargeable power source of the sterilizable surgical processor.

29. The method of claim 28, further comprising: inductively charging the rechargeable power source of the sterilizable surgical processor prior to sterilizing the sterilizable surgical processor.

30. The method of claim 28, further comprising: inductively charging the rechargeable power source of the sterilizable surgical processor after sterilizing the sterilizable surgical processor.

31. The method of claim 20, 21, or 22, wherein sterilizing the sterilizable surgical processor comprises: placing the sterilizable surgical processor in an autoclave after completion of the surgical procedure; and operating the autoclave to sterilize the sterilizable surgical processor using a high pressure and high temperature cleansing process.

32. The method of claim 20, 21, or 22, wherein sterilizing the sterilizable surgical processor comprises: sterilizing the sterilizable surgical processor via a liquid disinfection process.

33. The method of claim 20, 21, or 22, wherein sterilizing the sterilizable surgical processor comprises: sterilizing the sterilizable surgical processor via gas disinfection process.

34. The method of claim 20, 21, or 22, further comprising:placing the sterilizable surgical processor in a sterile bag after sterilization.

35. The method of claim 20, 21, or 22, wherein the sterilizable surgical processor includes at least one hermetically-sealed housing, at least one processing unit disposed in the at least one hermetically-sealed housing, and a rechargeable power source disposed in the at least one hermetically-sealed housing.

36. The method of claim 35, wherein the rechargeable power source is a high temperature rated rechargeable battery, and wherein the sterilizable surgical processor is configured to withstand exposure to heat and moisture during sterilization using an autoclave.

37. The method of claim 35, wherein the at least one hermetically-sealed housing is configured to prevent the sterilizable surgical processor and the rechargeable power source from being exposed to liquid or vapor or foreign materials.

38. A method comprising : placing a processing device within a sterile field during a surgical procedure; removing the processing device from the sterile field; and sterilizing the processing device after the surgical procedure.

39. The method of claim 38, wherein placing the processing device within the sterile field during the surgical procedure comprises: inductively coupling a processor coil of the processing device to an implantable coil of an implantable component that is configured to be implanted in a recipient during the surgical procedure.

40. The method of claim 39, further comprising: using the processor coil to communicate with the implantable component during a surgical procedure to implant the implantable component in the recipient.

41. The method of claim 40, wherein using the processor coil to communicate with the implantable component during the surgical procedure comprises: receiving, via the processor coil, results of one or more intraoperative measurements from the implantable component during the surgical procedure.

42. The method of claim 38, 39, 40, or 41, wherein the processing device includes at least one hermetically-sealed housing, at least one processing unit disposed in the at least one hermetically-sealed housing, and a rechargeable power source disposed in the at least one hermetically-sealed housing.

43. The method of claim 38, 39, 40, or 41, wherein after sterilizing the processing device, the method further comprises: reusing the processing device during a subsequent surgical procedure.

44. The method of claim 43, wherein after reusing the processing device during a subsequent surgical procedure, the method further comprises: sterilizing the processing device after the subsequent surgical procedure.

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