Diagnostic systems and methods for use during procedures associated with cochlear implants

Abstract

A diagnostic system for use during a procedure associated with a cochlear implant includes a computing module and a base module, the base module being configured to be attached to a rear side of the computing module and serving as a stand for the computing module. The computing module includes a display screen and a processor, the processor being configured to execute a diagnostic application and direct the display screen to display a graphical user interface associated with the diagnostic application. The base module includes an interface unit configured to be communicatively coupled to the processor and to the cochlear implant when the base module is attached to the rear side of the computing module.

Description

[0001] Background Information

[0002] During and after a surgical procedure in which a cochlear implant and electrode leads are implanted in a recipient, it may be desirable to perform various diagnostic procedures associated with the cochlear implant, electrode leads, and / or recipient. For example, during the insertion procedure of placing electrode leads within the cochlea, it may be desirable to monitor evoked responses (e.g., electrocochleographic ("ECoG" or "ECochG") potentials) that occur within the recipient in response to acoustic stimuli applied to the recipient. These evoked responses may indicate the positioning of the electrode within the cochlea, trauma that may have occurred to the cochlea during the insertion procedure, residual hearing in different regions of the cochlea when the electrode leads were inserted, and / or various other factors associated with the insertion procedure. BRIEF DESCRIPTION OF THE DRAWINGS

[0003] The accompanying drawings illustrate different embodiments and are part of the specification. The illustrated embodiments are merely examples and do not limit the scope of the present disclosure. Throughout the accompanying drawings, the same or similar reference numerals designate the same or similar elements.

[0004] Figure 1 An exemplary cochlear implant system according to the principles described herein is shown.

[0005] Figure 2 Illustration of a schematic structure of a human cochlea, according to the principles described herein.

[0006] Figure 3 An exemplary diagnostic system according to the principles described herein is shown.

[0007] Figure 4 A base module is shown separate from a computational module according to the principles described herein.

[0008] Figure 5-8 An exemplary configuration is shown in which a diagnostic system is used to perform one or more diagnostic operations during a surgical procedure involving a cochlear implant and electrode leads, according to principles described herein.

[0009] Figures 9A-9D Various disposable coil configurations are illustrated according to the principles described herein.

[0010] Figure 10A-13 FIG. 1 illustrates an embodiment of a device according to the principles described herein. Figure 3 An exemplary hardware implementation of a diagnostic system.

[0011] Fig.14An exploded view of a sterile kit according to the principles described herein is shown.

[0012] Fig.15 An exemplary acoustic delivery device according to the principles described herein is shown. DETAILED DESCRIPTION

[0013] Diagnostic systems and methods for use during a procedure associated with a cochlear implant are described herein. As will be described in more detail below, an exemplary diagnostic system includes a computing module and a base module. The base module is configured to be attached to the computing module and serve as a stand for the computing module. The computing module includes a display screen and a processor, the processor being configured to execute a diagnostic application and direct the display screen to display a graphical user interface associated with the diagnostic application. The base module houses an interface unit, the interface unit being configured to couple with the processor and to communicate with the cochlear implant when the base module is attached to the computing module.

[0014] In some examples, the base module includes an audio output port and a communication port, wherein the audio output port is configured to be selectively coupled to an acoustic transmission device (e.g., a tube with an ear insert, the ear insert is configured to be positioned within or near the entrance of the ear canal of a recipient of a cochlear implant), and the communication port is configured to be selectively coupled to a coil, the coil being configured to wirelessly communicate with the cochlear implant. In this configuration, the interface unit can generate acoustic stimulation and transmit the acoustic stimulation to the recipient via the audio output port and the acoustic transmission device. The interface unit can receive recorded data associated with the acoustic stimulation from the cochlear implant via the coil and the communication port.

[0015] In some examples, the recorded data represents an evoked response that occurs in the recipient in response to an acoustic stimulus. The evoked response can be an ECoG potential (e.g., cochlear microphonic potential, action potential, sum potential, etc.), an auditory nerve response, a brainstem response, a compound action potential, a stapedius muscle reflex, and / or any other type of neural response or physiological response that may occur in the recipient in response to applying an acoustic stimulus to the recipient. The evoked response may originate from neural tissue, hair cells to neural synapses, inner hair cells or outer hair cells, or other sources. The evoked response may also occur in response to electrical stimulation in addition or alternatively.

[0016] The recorded data received by the interface unit can be sent to the processor of the computing module through the interface unit. The processor can process the recorded data according to the diagnostic application. This example will be provided in more detail below.

[0017] The diagnostic systems and methods described herein provide a hardware platform that can be used in an operating room to implement various diagnostic operations during procedures associated with a cochlear implant. Exemplary diagnostic operations and processes that can be implemented in accordance with the systems and methods described herein are described in more detail in co-pending PCT Application No. _, Attorney Docket No. 3021-0494-WO, co-pending PCT Application No. _, Attorney Docket No. 3021-0495-WO, co-pending U.S. Application No. _, Attorney Docket No. 3021-0496, and co-pending U.S. Application No. _, Attorney Docket No. 3021-0497, each of which is filed on the same date as the present application and is incorporated herein by reference in its entirety.

[0018] As an example, the diagnostic systems and methods described herein may be used to monitor evoked responses that occur in response to acoustic stimuli applied during an insertion process in which an electrode lead connected to a cochlear implant is inserted into the cochlea of ​​a recipient. A processor of a computing module may direct a display screen to display one or more graphical user interfaces associated with the evoked responses. In this manner, a surgeon (or other user) may receive real-time monitoring feedback that assists the surgeon in properly positioning the electrode lead.

[0019] The systems and methods described herein may also be used in environments outside of an operating room. For example, a base module may be separate from a computing module and communicatively coupled to a computing device located, for example, in a clinician's office. The computing device may utilize the base module to implement various diagnostic procedures for a recipient that has been implanted with a cochlear implant. For example, the computing device may direct an interface unit included in the base module to apply an acoustic stimulus to a receptor of the cochlear implant and receive recorded data representing an induced response occurring in the receptor in response to the acoustic stimulus. The data may be used by the computing device to adjust one or more parameters associated with the cochlear implant. In this manner, an entity (e.g., a surgical center that performs surgery and various postoperative procedures) may only need to purchase a single diagnostic system in order to have diagnostic capabilities both inside and outside the operating room.

[0020] Figure 1An exemplary cochlear implant system 100 is shown. As shown, the cochlear implant system 100 may include a microphone 102, an acoustic processor 104, a headpiece 106, a cochlear implant 108, and an electrode lead 110, in which a coil is disposed. The electrode lead 110 may include an array of electrodes 112 disposed on a distal portion of the electrode lead 110, and the electrodes 112 are configured to be inserted into the cochlea to stimulate the cochlea when the distal portion of the electrode lead 110 is inserted into the cochlea of ​​the recipient. One or more other electrodes (e.g., including a ground electrode, not explicitly shown) may also be disposed on other portions of the electrode lead 110 (e.g., on a proximal portion of the electrode lead 110) to, for example, provide a current return path for the stimulation current generated by the electrode 112 and remain outside the cochlea after the electrode lead 110 is inserted into the cochlea. As shown, the electrode lead 110 may be pre-bent so as to fit comfortably within the spiral shape of the cochlea. Additional or alternative components may also be included within cochlear implant system 100 , as may serve a particular implementation.

[0021] As shown, cochlear implant system 100 may include various components configured to be located outside the recipient's body, including but not limited to microphone 102, acoustic processor 104, and headpiece 106. Cochlear implant system 100 may also include various components configured to be implanted in the recipient's body, including but not limited to cochlear implant 108 and electrode leads 110.

[0022] Microphone 102 may be configured to detect audio signals presented to a user. Microphone 102 may be implemented in any suitable manner. For example, microphone 102 may include a microphone configured to be disposed within the concha of the ear near the entrance to the ear canal, such as the T-MIC from Advanced Bionics. TM Microphone. Such a microphone may be held within the concha of the ear near the entrance to the ear canal during normal operation by a boom or stem attached to an ear hook configured to selectively attach to the acoustic processor 104. Additionally or alternatively, the microphone 102 may also be implemented by one or more microphones disposed within the headpiece 106, one or more microphones disposed within the acoustic processor 104, one or more beam-forming microphones, and / or any other suitable microphone that may serve a particular embodiment.

[0023] The acoustic processor 104 may be configured to direct the cochlear implant 108 to generate electrical stimulation (also referred to herein as "stimulation current") representing one or more audio signals (e.g., one or more audio signals detected by the microphone 102, input via an auxiliary audio input port, input via a clinician programming interface (CPI) device, etc.) and apply the electrical stimulation to one or more stimulation sites associated with the auditory pathway of the recipient (e.g., the auditory nerve). Exemplary stimulation sites include, but are not limited to, one or more locations within the cochlea, cochlear nucleus, inferior colliculus, and / or any other nucleus in the auditory pathway. To this end, the acoustic processor 104 may process the one or more audio signals according to a selected acoustic processing strategy or program to generate appropriate stimulation parameters for controlling the cochlear implant 108. The acoustic processor 104 may be housed in any suitable housing (e.g., a behind-the-ear ("BTE") unit, a body-worn device, a headpiece 106, and / or any other acoustic processing unit that may serve a particular embodiment).

[0024] In some examples, acoustic processor 104 may wirelessly transmit stimulation parameters (e.g., in the form of data words included in a forward telemetry sequence) and / or power signals to cochlear implant 108 via a wireless communication link 114 between headpiece 106 and cochlear implant 108 (e.g., a wireless link between a coil disposed within headpiece 106 and a coil physically coupled to cochlear implant 108). It will be appreciated that communication link 114 may include a bidirectional communication link and / or one or more dedicated unidirectional communication links.

[0025] Head piece 106 may be communicatively coupled to acoustic processor 104 and may include an external antenna (e.g., a coil and / or one or more wireless communication components) configured to facilitate selective wireless coupling of acoustic processor 104 to cochlear implant 108. Additionally or alternatively, head piece 106 may also be used to selectively and wirelessly couple any other external device to cochlear implant 108. To this end, head piece 106 may be configured to be affixed to a recipient's head and positioned such that an external antenna housed within head piece 106 is communicatively coupled to a corresponding implantable antenna (which may also be implemented by a coil and / or one or more wireless communication components) included within cochlear implant 108 or otherwise associated with the cochlear implant. In this manner, stimulation parameters and / or power signals may be wirelessly transmitted between acoustic processor 104 and cochlear implant 108 via communication link 114 (which may include a bidirectional communication link and / or one or more dedicated unidirectional communication links, as may serve a particular implementation).

[0026] Cochlear implant 108 may include any suitable type of implantable stimulator. For example, cochlear implant 108 may be implemented by an implantable cochlear stimulator. Additionally or alternatively, cochlear implant 108 may include a brainstem implant and / or any other type of cochlear implant that is implantable in a recipient and configured to apply stimulation to one or more stimulation sites located along the recipient's auditory pathway.

[0027] In some examples, cochlear implant 108 may be configured to generate electrical stimulation representative of an audio signal processed by acoustic processor 104 (e.g., an audio signal detected by microphone 102) in accordance with one or more stimulation parameters sent thereto by acoustic processor 104. Cochlear implant 108 may also be configured to apply electrical stimulation to one or more stimulation sites (e.g., one or more intra-cochlear regions) within a recipient via electrodes 112 disposed along electrode leads 110. In some examples, cochlear implant 108 may include a plurality of independent current sources, each of which is associated with a channel defined by one or more of electrodes 112. In this manner, different stimulation current levels may be applied to a plurality of stimulation sites simultaneously via a plurality of electrodes 112.

[0028] Figure 2 The figure shows a schematic structure of a human cochlea 200 into which the electrode lead 110 can be inserted. Figure 2 As shown in FIG. 1 , the cochlea 200 is spiral shaped, starting with a base 202 and ending with a top 204. The cochlea 200 is provided with an auditory nerve tissue 206. Figure 2 The auditory nerve tissue is indicated by Xs in FIG. The auditory nerve tissue 206 is organized in a tonotopic manner within the cochlea 200. Relatively low frequencies are encoded at or near the top 204 of the cochlea 200 (also referred to as the "apical region"), while relatively high frequencies are encoded at or near the base 202 (also referred to as the "basal region"). Therefore, electrical stimulation applied by an electrode disposed in the apical region (i.e., the "apical electrode") can cause the receptor to perceive relatively low frequencies, while electrical stimulation applied by an electrode disposed in the basal region (i.e., the "basal electrode") can cause the receptor to perceive relatively high frequencies. On a particular electrode lead, the demarcation between the apical electrode and the basal electrode can vary depending on the insertion depth of the electrode lead, the anatomical structure of the recipient's cochlea, and / or any other factors that may serve a particular embodiment.

[0029] The diagnostic systems and methods described herein may be used during procedures associated with a cochlear implant, such as cochlear implant 108. For example, the diagnostic systems and methods described herein may be used intraoperatively in an operating room during a surgical procedure associated with cochlear implant 108. For illustration, the diagnostic systems and methods described herein may be used during a surgical procedure in which cochlear implant 108 and electrode lead 110 are implanted in a recipient and / or during a surgical procedure in which cochlear implant 108 and / or electrode lead 110 are explanted from a recipient (in vivo). The diagnostic systems and methods described herein may also be used additionally or alternatively postoperatively. For example, the diagnostic systems and methods described herein may be used to monitor the health of the cochlea and / or the performance achieved by cochlear implant 108 immediately after cochlear implant 108 and / or electrode lead 110 have been implanted in a recipient. As another example, the diagnostic systems and methods described herein may also be used in a clinician's office to adjust one or more operating parameters associated with a cochlear implant system that has been fitted to a recipient (in vivo).

[0030] Figure 3 An exemplary diagnostic system 300 is shown. As shown, the diagnostic system 300 includes a computing module 302 and a base module 304. The computing module 302 includes a display screen 306 and a processor 308. The base module 304 includes an interface unit 310, an audio amplifier 312, an audio output port 314, a communication port 316, and a port 318. The computing module 302 and the base module 304 may also include additional or alternative components, as will be described herein. Exemplary embodiments of the computing module 302 and the base module 304 are described herein.

[0031] exist Figure 3 In the configuration configuration shown in , the base module 304 is physically attached to the computing module 302. In this configuration configuration, the processor 302 is communicatively coupled to the interface unit 310 via a connection 320. The connection 320 can be implemented by any suitable connection that can serve a specific implementation (e.g., an internal USB connection). As will be described in more detail below, the base module 304 can be selectively separated from the computing module 302 and connected to a different computing device via a port 318.

[0032] Display screen 306 may be configured to display any suitable content associated with an application program executed by processor 308. Display screen 306 may be implemented by a touch screen and / or by any other type of display screen that may serve a particular implementation.

[0033] Processor 308 may be configured to execute a diagnostic application associated with a cochlear implant (e.g., cochlear implant 108). For example, processor 308 may execute a diagnostic application that may be used during a surgical procedure associated with a cochlear implant. The diagnostic application may be configured to perform various diagnostic operations associated with a cochlear implant during the surgical procedure. Exemplary diagnostic operations are described herein.

[0034] In some examples, processor 308 may direct display screen 306 to display a graphical user interface associated with a diagnostic application being executed by processor 308. A user may interact with the graphical user interface to adjust one or more parameters associated with the cochlear implant and / or otherwise obtain information that may be useful during a procedure associated with the cochlear implant.

[0035] Base module 304 may be configured to attach to computing module 302 and serve as a stand for computing module 302. Examples of these features are described herein.

[0036] The interface unit 310 is configured to be communicatively coupled to the processor 308 via the connection 320 when the base module 304 is attached to the computing module 302. The interface unit 310 is also configured to be communicatively coupled to the cochlear implant when the base module 304 is attached to the computing module 302. In this manner, the interface unit 310 provides an interface between the processor 308 and the cochlear implant.

[0037] The interface unit 310 can be communicatively coupled to the cochlear implant via the communication port 316. For example, the communication port 316 can be selectively coupled to a coil configured to wirelessly communicate with the cochlear implant (e.g., a coil included in a headpiece (e.g., headpiece 106), or a disposable stand-alone coil such as will be described herein). The interface unit 310 can communicate with the cochlear implant by sending data to the cochlear implant and / or receiving data from the cochlear implant via the coil connected to the communication port 316.

[0038] The interface unit 310 may also be configured to generate acoustic stimuli (e.g., sound waves) and provide the acoustic stimuli to a receptor of the cochlear implant. To this end, the audio output port 314 is configured to selectively couple to an acoustic transmission device. As will be described below, the acoustic transmission device may be implemented by a tube having a distal portion configured to be disposed in or near the entrance of the ear canal of a receptor of the cochlear implant. When the acoustic transmission device is connected to the audio output port 314, the interface unit 310 may send the acoustic stimuli to the receptor via the acoustic transmission device. An exemplary acoustic transmission device is described herein.

[0039] As shown, the audio amplifier 312 can be positioned in the path between the interface unit 310 and the audio output port 314. In this configuration, the audio amplifier 312 can be configured to amplify the acoustic stimulus before transmitting the acoustic stimulus to the recipient via the audio output port 314 and the acoustic transmission device. In some alternative examples, the acoustic stimulus generated by the interface unit 310 does not need to be amplified, thereby eliminating the need to include the audio amplifier 312 in the base module 304. Therefore, in some embodiments, the base module 304 does not include the audio amplifier 312.

[0040] In some examples, the diagnostic system 300 can be configured to self-calibrate and / or perform in-situ testing. For example, the processor 308 can calibrate the amplitude level of the acoustic stimulus generated by the interface unit 310 before and / or during the surgical procedure. Such self-calibration and in-situ testing can be implemented in any suitable manner.

[0041] As mentioned, the base module 304 may be selectively separable from the computational module 302. For illustration, Figure 4 A configuration configuration 400 is shown in which the base module 304 is separated from the computing module 302. The separation is illustrated by arrow 402. When separated, the interface unit 310 of the base module 304 can be communicatively coupled to the computing device 404. For example, the interface unit 310 can be communicatively coupled to the computing device 404 by plugging a cable (e.g., a USB cable) into the port 318 and into the computing device 404. In this configuration configuration, the computing device 404 can utilize the interface unit 310 to interface with a cochlear implant (e.g., by providing acoustic stimulation to a receptor of the cochlear implant and / or receiving recorded data from the cochlear implant).

[0042] Figure 5 An exemplary configuration 500 is depicted in which the diagnostic system 300 is used to perform one or more diagnostic operations during a surgical procedure involving a cochlear implant and an electrode lead. The surgical procedure may include, for example, an insertion procedure in which the cochlear implant is inserted into an incision pocket formed in a recipient and / or in which a distal portion of an electrode lead is positioned within the cochlea.

[0043] Different anatomical features of the recipient ear are Figure 5 Specifically, anatomical features include the auricle 502 (ie, the outer ear), the ear canal 504, the middle ear 506, and the cochlea 508. Although no specific incisions or other obvious surgical features are shown in Figure 5508. However, it will be understood that such elements may be present while a surgical procedure is ongoing. For example, an incision may be present to allow the surgeon to access the recipient from the inside to insert a lead into the cochlea 508. In some procedures, the pinna 502 may be taped and covered with a surgical drape to cover the ear canal 504 (e.g., to help prevent fluid associated with the procedure from reaching the ear canal 504).

[0044] exist Figure 5 In the example of FIG. 5 , a cochlear implant 510 and an electrode lead 512 are shown as being implanted in a recipient. Cochlear implant 510 can be similar to, for example, cochlear implant 108, and electrode lead 512 can be similar to, for example, electrode lead 110. Electrode lead 512 includes a plurality of electrodes (e.g., electrode 514 being the most distal electrode disposed on electrode lead 512).

[0045] As shown, cable 516 of head piece 518 is connected to communication port 316. In this configuration, interface unit 310 can communicate wirelessly with cochlear implant 510 via coils and / or other electronics included in head piece 518 (which can be similar to head piece 106).

[0046] As also shown, an acoustic transmission device 520 is connected to the audio output port 314. The acoustic transmission device 520 includes a tube 522 and an earplug 524. The earplug 524 is configured to fit at or within the entrance of the ear canal 504. The tube 522 and the earplug 524 together form an acoustic propagation channel 526 that transmits the acoustic stimulus provided by the interface unit 310 to the ear canal 504. The tube 522 and the earplug 524 can be made of any suitable material that can serve a specific embodiment.

[0047] In some examples, the processor 308 may execute a diagnostic application during the surgical procedure. According to the diagnostic application, the processor 308 may send a command (also referred to as a stimulation command) to the interface unit 310 via the connection 320 so that the interface unit 310 applies an acoustic stimulus to the subject and receives recorded data representing an evoked response that occurs in the subject in response to the acoustic stimulus. In response to receiving the command, the interface unit 310 may generate an acoustic stimulus and apply the acoustic stimulus to the subject via the audio output port 314 and the acoustic transmission device 520. The interface unit 310 may also send a command (also referred to as a recording command) to the cochlear implant 510 via the communication port 316 and the headpiece 518 so that the cochlear implant 510 uses the electrodes 514 to record the evoked response that occurs in response to the acoustic stimulus. The cochlear implant 510 may send the recorded data back to the interface unit 310 via the headpiece 518 and the communication port 316. The interface unit 310 may send the recorded data to the processor 308 via the connection 320. The processor 308 may process the recorded data and direct the display screen 306 to display one or more graphical user interfaces associated with the recorded data.

[0048] As another example, according to the diagnostic application, the processor 308 may send a command to the interface unit 310 via the connection 320 so that the interface unit 310 directs the cochlear implant 510 to apply electrical stimulation to the recipient via one or more electrodes included on the electrode lead 512. The command may further direct the interface unit 310 to receive recorded data representing an evoked response that occurs in the recipient in response to the electrical stimulation. In response to receiving the command, the interface unit 310 may send a command to the cochlear implant 510 so that the cochlear implant 510 generates electrical stimulation and applies the electrical stimulation to the recipient via the one or more electrodes, and so that the cochlear implant 510 uses one or more of the electrodes included on the electrode lead 512 to record the evoked response that occurs in response to the electrical stimulation. The cochlear implant 510 may send the recorded data back to the interface unit 310 via the headpiece 518 and the communication port 316. The interface unit 310 may send the recorded data to the processor 308 via the connection 320. The processor 308 may process the recorded data and direct the display screen 306 to display one or more graphical user interfaces associated with the recorded data.

[0049] In configuration configuration 500, head piece 518 is directly connected to communication port 316 via cable 516. Thus, in configuration configuration 500, interface unit 310 is configured to directly control cochlear implant 510. Figure 6An alternative configuration 600 is shown in which an acoustic processor 602 is included in the communication path between the interface unit 310 and the cochlear implant 510. The acoustic processor 602 can be similar to any of the acoustic processors described herein (e.g., the acoustic processor 104). In some examples, the acoustic processor 602 is recipient-agnostic. In other words, the acoustic processor 602 is not specifically configured for the receptor of the cochlear implant 510. Instead, the acoustic processor 602 can be used in a variety of different surgical procedures associated with a plurality of different receptors.

[0050] As shown, the acoustic processor 602 is connected to the communication port 316 via a cable 604. The acoustic processor 602 is also connected to the head piece 518 via a cable 516. In this configuration, the acoustic processor 602 can relay data and / or commands between the interface unit 310 and the cochlear implant 510.

[0051] As mentioned, during some surgical procedures, a surgical drape is placed over the recipient's ears and / or head. The surgical drape increases the spacing between the head piece 518 and the cochlear implant 510. In some scenarios, this can make it difficult to maintain proper alignment between the head piece 518 and the coil included in the cochlear implant 510. This is because the alignment between the head piece 518 and the coil of the cochlear implant 510 is essentially achieved using magnets included in the head piece 518. In the event of increased spacing, the magnetic force of the magnets may not be sufficient to keep the head piece 518 properly aligned with the coil of the cochlear implant 510.

[0052] Thus, in some examples, instead of using head piece 518 to communicate with cochlear implant 510, a disposable coil may be connected to communication port 316 instead. The disposable coil is not included in a housing (e.g., head piece 518) that contains other components (e.g., microphone and other electronic devices). Therefore, the disposable coil can have a relatively thin profile. This can allow the disposable coil to be inserted into the same incision pocket in the recipient's body as the cochlear implant 510. In this way, the disposable coil can be held in place by the incision pocket, thereby ensuring that the disposable coil is properly aligned with the coil of the cochlear implant 510.

[0053] For illustration, Figure 7An exemplary configuration 700 is shown in which a disposable coil 702 and a cochlear implant 510 are inserted into the same incisional pocket of a recipient. As shown, a head piece 518 is not included in the configuration 700. Instead, the disposable coil 702 is connected to a cable 704, which is connected to an acoustic processor 602. The acoustic processor 602 is connected to the communication port 316 via a cable 706. In alternative embodiments, the acoustic processor 602 may not be included in the configuration 700. In these alternative embodiments, the cable 704 may be directly connected to the communication port 316.

[0054] Figure 8 An alternative configuration configuration 800 is shown that employs a disposable coil 702. In the configuration configuration 800, the disposable coil 702 is directly coupled to the head piece 518 via a cable 704 (e.g., the cable 704 may be directly plugged into a port of the head piece 518). As shown, the head piece 518 is connected to the acoustic processor 602 via a cable 516, and the acoustic processor 602 is connected to the communication port 316 via the cable 604. In the configuration configuration 800, due to the placement of the disposable coil 702 within the incision pocket, the head piece 518 does not need to be magnetically aligned with the cochlear implant 510.

[0055] In some examples, the disposable coil 702 is included in a kit provided to the surgeon for a specific surgical procedure associated with his or her specific recipient. In these examples, the disposable coil 702 is sterile or sterilizable. After the surgical procedure is completed, the disposable coil 702 can be discarded.

[0056] Figures 9A-9D Various disposable coil configurations 900 that may be used in accordance with the systems and methods described herein are illustrated. It will be understood that the disposable coil configuration(s) 900 are merely examples of the many different types of disposable coil configurations that may be used in accordance with the systems and methods described herein.

[0057] like Fig. 9A As shown in FIG. 7 , the disposable coil configuration 900 - 1 includes a coil 902 - 1 contained within a housing 904 - 1 . The housing 904 - 1 may be implemented by any suitable overmolding or other thin housing. The combination of the coil 902 - 1 and the housing 904 - 1 may implement the disposable coil 702 .

[0058] The disposable coil configuration 900 - 1 also includes a cable 906 - 1 connected to the housing 904 - 1 . The cable 906 - 1 can house one or more conductive vias (eg, wires) conductively coupled to the coil 902 - 1 and can implement the cable 704 .

[0059] In disposable coil configuration 900-1, magnet 908 is included within housing 904-1. Magnet 908 can be configured to magnetically couple with a corresponding magnet included in the coil of cochlear implant 510. In this manner, coil 902 can remain aligned with the coil of cochlear implant 510 when coil 902-1 and housing 904-1 are located in the incision pocket.

[0060] Fig. 9B The disposable coil configuration configuration 900-2 shown in FIG. 1 is similar to the disposable coil configuration configuration 900-1 in that the disposable coil configuration configuration 900-2 includes a coil 902-2, a housing 904-2, and a cable 906-2. However, unlike the disposable coil configuration configuration 900-2, the disposable coil configuration configuration 900-2 does not include a magnet 908. The disposable coil configuration configuration 900-2 may be used in situations where it may not be necessary to maintain alignment between the coil 902-2 and the coil of the cochlear implant 510 because the coil 902-2, the housing 904-2, and the cochlear implant 510 fit tightly within the same incision pocket.

[0061] Fig. 9C The disposable coil configuration structure 900-3 shown in the figure includes a plurality of coils (i.e., coils 902-3 to 902-6) contained within a housing 904-3. The disposable coil configuration structure 900-3 also includes a cable 906-3 connected to the housing 904-3. As shown, the surface area covered by the combination of coils 902-3 to 902-6 is relatively larger than the surface area covered by a single coil (e.g., coil 902-1). This increased surface area coverage can further ensure that at least one of the coils 902-3 to 902-6 is aligned with the coil of the cochlear implant 510.

[0062] Fig.9D The disposable coil configuration 900-4 shown in FIG. 1 is similar to the disposable coil configuration 900-2 in that the disposable coil configuration 900-4 includes a coil 902-7, a housing 904-4, and a cable 906-4 without a magnet. However, as illustrated by the hatch line of the housing 904-4, one or more ferrite layers may be included within the housing 904-4. The ferrite layers may be configured to assist in aligning the coil 902-7 with the coil of the cochlear implant 708.

[0063] Now combine Figure 10A-13 To describe an exemplary hardware implementation of the diagnostic system 300. Specifically, Fig. 10A shows a left perspective view of the diagnostic system 300, Fig. 10B shows a right perspective view of the diagnostic system 300, Fig.11A shows a front view of the diagnostic system 300, Fig. 11B shows a rear view of the diagnostic system 300, Fig. 12A shows a left side view of the diagnostic system 300, Fig. 12B A right side view of the diagnostic system 300 is shown, and Fig.13 A rear perspective view of diagnostic system 300 is shown.

[0064] Figure 10A-13 The hardware implementation of the diagnostic system 300 illustrated in FIG. 1 includes a computing module 302 and a base module 304. As illustrated, the computing module 302 includes a front side 1002, a back side 1004, a left side 1006, a right side 1008, a top side 1010, and a bottom side 1012.

[0065] Display screen 306 is located on front side 1002 of computing module 302. Various other components are also located on front side 1002 of computing module 302. For example, fingerprint scanner 1014, physical input buttons 1016, and webcam 1018 are all shown as being included on front side 1002 of computing module 302. It will be understood that any of these components may also be located on any other side of computing module 302, as may serve a particular implementation.

[0066] Fingerprint scanner 1014 is configured to facilitate authentication of a user of diagnostic system 300. For example, fingerprint scanner 1014 may detect a fingerprint of a user and provide data representing the fingerprint to processor 308. Processor 308 may process the fingerprint data in any suitable manner (e.g., by comparing the fingerprint to known fingerprints contained in a database) to authenticate the user.

[0067] Webcam 1018 may be configured to facilitate video communications between a user of diagnostic system 300 and a remotely located user (eg, during a surgical procedure). Such video communications may be implemented in any suitable manner.

[0068] The physical input buttons 1016 may be implemented, for example, by a steering wheel and / or any other suitable type of physical input buttons. A user of the diagnostic system 300 may interact with the physical input buttons 1016 to implement various operations for the diagnostic application being executed by the processor 308. For example, the user may use the physical input buttons 1016 to interact with a graphical user interface displayed on the display screen 306.

[0069] In some examples, the physical input buttons 1016 can be configured to be selectively programmed (e.g., as hot keys) to implement one or more functions associated with the diagnostic application. For example, a particular physical input button 1016 can be programmed by a user to start and / or stop applying acoustic stimulation to a receptor of a cochlear implant via the diagnostic system 300.

[0070] In some examples, the processor 308 may be configured to wirelessly connect to an input device that is configured to be used by a user in connection with a diagnostic application. For example, the processor 308 may be configured to wirelessly connect to a keyboard, a mouse, a remote control, and / or any other wireless input device that may serve a particular implementation (e.g., via Bluetooth and / or any other suitable wireless communication protocol). In this manner, a user may selectively use the physical input buttons 1016, the touch screen capabilities of the display screen 306, and / or a wireless input device to interact with the diagnostic system 300.

[0071] Additionally or alternatively, the processor 308 may also be configured to connect (e.g., via a wired connection or a wireless connection) to a different computing device to facilitate communication with the different computing devices. For example, the processor 308 may be wirelessly connected to a remote computing device via a network. In such a configuration, the processor 308 may receive data (e.g., recipient-specific data) from the remote computing device and / or send data to the remote computing device.

[0072] As shown, a hole 1020 may be formed in computing module 302 and may be configured to serve as a handle for diagnostic system 300. A user may grasp computing module 302 by placing his or her fingers in hole 1020.

[0073] As shown, barcode scanner 1022 can be located on left side 1006 of computing module 302. Alternatively, barcode scanner 1022 can also be located on any other side of computing module 302. In some examples, barcode scanner 1022 can be configured to scan activation codes included on one or more components associated with a procedure being performed for cochlear implant 510. The activation code can be used to associate (e.g., register) the component with cochlear implant 510.

[0074] like Fig. 11B As shown in FIG. 1 , computing module 302 may include batteries 1024-1 and 1024-2. Battery 1024 may be configured to provide operating power to various components included within computing module 302 and base module 304. In some examples, battery 1024 may be hot-swappable. In other words, one of batteries 1024 (e.g., battery 1024-1) may be removed and replaced while another battery (e.g., battery 1024-2) is used to provide power to computing module 302 and base module 304.

[0075] like Fig. 10B and Fig. 12BAs shown in FIG. 1 , the ports 314 , 316 , and 318 are located on the side surface 1026 of the base module 304 . Alternatively, the ports 314 , 316 , and 318 may also be located on any other surface of the base module 304 .

[0076] As described above, base module 304 can be configured to serve as a stand for computing module 302 when base module 304 is attached to computing module 302. Figures 12A-12B The middle figure shows the pedestal function of the base module 304.

[0077] As shown, base module 304 includes a top surface 1028 configured to selectively attach to the rear side 1004 of computing module 302. Alternatively, base module 404 may also be attached to any other side of computing module 302. Base module 304 also includes a bottom surface 1030 configured to be placed on a resting surface 1032. Bottom surface 1030 is angled relative to the rear side 1004 of computing module 302. This provides a viewing angle 1034 greater than zero degrees relative to resting surface 1032 for display screen 306. In some examples, base module 304 may be adjustable to selectively provide different viewing angles for display screen 306 relative to resting surface 1032. This adjustability may be implemented in any suitable manner. For example, a user may manually adjust bottom surface 1030 to different angles relative to the rear side 1004 of computing module 302.

[0078] Fig.13 The figure shows an exemplary configuration configuration in which the base module 304 is separated from the computing module 302. The base module 304 can be separated from the computing module 302 in any suitable manner. For example, the base module 304 can include one or more locking mechanisms that a user can actuate to separate the base module 304 from the computing module 302.

[0079] Fig.14 The figure shows a disassembled sterile kit 1400, which can be provided for use in conjunction with the diagnostic system 300 in a process associated with a cochlear implant. The sterile kit 1400 includes a package 1402 and a plurality of acoustic transmission devices 1404 (e.g., acoustic transmission devices 1404-1 to acoustic transmission devices 1404-3). The sterile kit 1400 may also include one or more other components, as may serve a particular embodiment. For example, the sterile kit 1400 may also include one or more disposable coils, such as any of the disposable coils described herein.

[0080] As shown, packaging 1402 may include activation code label 1406. Activation code label 1406 may be scanned by bar code reader 1022 to associate the contents of sterile kit 1400 with a specific cochlear implant and / or receptor.

[0081] The acoustic transmission devices 1404 may each have different sizes. For example, the acoustic transmission device 1404-1 may be a "large" model, the acoustic transmission device 1404-2 may be a "medium" model, and the acoustic transmission device 1404-3 may be a "small" model. Each acoustic transmission device 1404 may include a label (e.g., label 1406), which may be color-coded, include a printed activation code, or be otherwise marked, as may serve a particular implementation.

[0082] In this way, a surgeon or other user can select an acoustic delivery device 1404 of the appropriate size for use with a particular recipient. Each acoustic delivery device 1404 can be sterile so that they can be used in an operating room.

[0083] Fig.15 The acoustic transmission device 1404-1 is shown in more detail. As shown, the acoustic transmission device 1404-1 includes a tube 1502 and an earplug 1504 connected to the distal end of the tube 1502. The acoustic transmission device 1404-1 may further include a luer and / or any other components that may serve a specific embodiment. The earplug 1504 is configured to be placed at or within the entrance of the ear canal of the recipient of the cochlear implant. The proximal end of the tube 1502 can be connected to the audio output port 314. In this configuration, acoustic stimulation can be transmitted to the receptor of the cochlear implant via the tube 1502.

[0084] In the foregoing description, various exemplary embodiments have been described with reference to the accompanying drawings. However, it will be apparent that various modifications and changes may be made to the described embodiments, and additional embodiments may be implemented, without departing from the scope of the invention as set forth in the appended claims. For example, certain features of one embodiment described herein may be combined with or replace features of another embodiment described herein. Accordingly, the description and drawings are to be regarded as illustrative rather than restrictive.

Claims

1. A diagnostic system for use during a procedure associated with a cochlear implant, the diagnostic system comprising: A computing module comprising: a display screen, and a processor configured to execute a diagnostic application and direct the display screen to display a graphical user interface associated with the diagnostic application; and a base module configured to be attached to the computing module and serve as a stand for the computing module, the base module housing an interface unit configured to be communicatively coupled to the processor and to a cochlear implant when the base module is attached to the computing module, wherein the base module comprises a communication port configured to selectively couple to a coil configured to wirelessly communicate with the cochlear implant, and the interface unit is further configured to communicate with the cochlear implant by sending data to and / or receiving data from the cochlear implant via the coil connected to the communication port such that the interface unit provides an interface between the processor of the computing module and the cochlear implant, and wherein the base module comprises an audio output port configured to selectively couple to an acoustic transmission device, and the interface unit is further configured to generate acoustic stimuli and transmit the acoustic stimuli to a receptor of the cochlear implant via the audio output port and the acoustic transmission device.

2. The diagnostic system of claim 1, wherein: The interface unit is also configured to receive recorded data associated with the acoustic stimulation from a cochlear implant via the coil and the communication port.

3. The diagnostic system of claim 2, wherein: The base module also houses an audio amplifier configured to amplify the acoustic stimulus before it is transmitted to the recipient.

4. The diagnostic system of claim 2, wherein: The recorded data represents an evoked response occurring in the subject in response to the acoustic stimulus.

5. The diagnostic system of claim 2, wherein: The interface unit is configured to receive a command from the processor to generate an acoustic stimulus and to generate the acoustic stimulus in response to the command.

6. The diagnostic system of claim 2, wherein: The interface unit is configured to send the recorded data to a processor.

7. The diagnostic system of claim 6, wherein: The processor is configured to process the recorded data in accordance with a diagnostic application.

8. The diagnostic system of claim 2, wherein: The interface unit is configured to send commands to the cochlear implant via the communication port and the coil, wherein the commands are configured to direct the cochlear implant to acquire the recorded data using one or more electrodes disposed on an electrode array coupled to the cochlear implant.

9. The diagnostic system of claim 1, wherein: The base module is configured to be separate from the computing module and communicatively coupled to a computing device different from the computing module.

10. The diagnostic system of claim 9, wherein: The base module includes a port configured to attach to a cable that communicatively couples the interface unit to a computing device when the base module is detached from the computing module.

11. The diagnostic system of claim 1, wherein: The bottom surface of the base module is angled relative to the computing module such that when the base module is placed on a resting surface and serves as a stand for the computing module, the base module provides a viewing angle for the display screen greater than zero degrees relative to the resting surface.

12. The diagnostic system of claim 11, wherein: The base module is adjustable to selectively provide different viewing angles from the display screen relative to the resting surface.

13. The diagnostic system of claim 1, wherein: The computing module also includes a fingerprint scanner configured to facilitate authentication of a user of the diagnostic system.

14. The diagnostic system of claim 1, wherein: The computing module also includes a barcode scanner configured to scan an activation code included with one or more components associated with the process.

15. The diagnostic system of claim 1, wherein: The computing module also includes one or more physical input buttons configured to be selectively programmed to implement one or more functions associated with the diagnostic application.

16. The diagnostic system of claim 1, wherein: The processor is configured to wirelessly interface with an input device configured for use by a user in connection with a diagnostic application.

17. The diagnostic system of claim 1, further comprising a disposable coil configured to connect to the interface unit.

18. A basic module, comprising: configured to be selectively attached to a surface of a computing module, the computing module including a processor configured to execute a diagnostic application related to a procedure associated with a cochlear implant; an interface unit housed within the base module and configured to generate acoustic stimuli and configured to communicatively couple with a processor of the computing module and with the cochlear implant when the base module is attached to the computing module; an audio amplifier housed within the base module and configured to amplify the acoustic stimuli; an audio output port configured to transmit the amplified acoustic stimuli to a receptor of the cochlear implant via an acoustic transmission device connected to the audio output port; and a communication port configured to selectively couple to a coil configured to wirelessly communicate with the cochlear implant, wherein the interface unit is further configured to communicate with the cochlear implant by sending data to and / or receiving data from the cochlear implant via the coil connected to the communication port such that the interface unit provides an interface between the processor of the computing module and the cochlear implant.

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