The present application relates generally to medical implants (e.g., implantable medical prostheses) having active components (e.g., transducers; actuators; microphones; reservoirs of liquid medicament).
Medical devices have provided a wide range of therapeutic benefits to recipients over recent decades. Medical devices can include internal or implantable components/devices, external or wearable components/devices, or combinations thereof (e.g., a device having an external component communicating with an implantable component). Medical devices, such as traditional hearing aids, partially or fully-implantable hearing prostheses (e.g., bone conduction devices, mechanical stimulators, cochlear implants, etc.), pacemakers, defibrillators, functional electrical stimulation devices, and other medical devices, have been successful in performing lifesaving and/or lifestyle enhancement functions and/or recipient monitoring for a number of years.
The types of medical devices and the ranges of functions performed thereby have increased over the years. For example, many medical devices, sometimes referred to as “implantable medical devices,” now often include one or more instruments, apparatus, sensors, processors, controllers or other functional mechanical or electrical components that are permanently or temporarily implanted in a recipient. These functional devices are typically used to diagnose, prevent, monitor, treat, or manage a disease/injury or symptom thereof, or to investigate, replace or modify the anatomy or a physiological process. Many of these functional devices utilize power and/or data received from external devices that are part of, or operate in conjunction with, implantable components.
In one aspect disclosed herein, an apparatus comprises a first portion configured to be implanted at a first location on or within a recipient's body and a second portion configured to be implanted on or within the recipient's body and configured to be mechanically coupled to a transducer. The second portion comprises an orifice and an elongate element extending through the orifice. The elongate element is configured to be in mechanical communication with a second location on or within the recipient's body, the second location spaced from the first portion. The first portion and the second portion are configured to be implanted with the elongate element in mechanical communication with the second location prior to the second portion being mechanically coupled to the transducer.
In another aspect disclosed herein, an apparatus comprises a fixation portion configured to be implanted on or within a recipient's body and an elongate portion configured to be in mechanical communication with a transducer and a target portion of the recipient's body. The elongate portion extends at least partially through the fixation portion and is configured to transmit vibrational energy from the transducer to the target portion and/or from the target portion to the transducer. The apparatus further comprises at least one mechanically compliant portion between the fixation portion and the elongate portion. The at least one mechanically compliant portion is configured to substantially inhibit escape of the vibrational energy from the elongate portion to portions of the recipient's body spaced from the target portion and/or to substantially inhibit vibrational energy not from the target portion from reaching the transducer.
In another aspect disclosed herein, a method comprises at least partially implanting an assembly on or within a recipient's body. The assembly comprises a fixation portion and an elongate portion extending at least partially through the fixation portion. Said at least partially implanting comprises affixing the fixation portion to a first location of the recipient's body. The method further comprises, while the fixation portion is affixed to the first location, adjusting a position and/or orientation of the elongate portion to be in operative communication with a second location of the recipient's body. The method further comprises, while the elongate portion is in operative communication with the second location of the recipient's body, operatively coupling the elongate portion with a transducer and/or a reservoir configured to contain at least one medicament.
In another aspect disclosed herein, an apparatus comprises a fixation bracket configured to be affixed at a first location on or within a recipient's body and an elongate fluid conduit configured to be at least partially within the fixation bracket. The elongate fluid conduit comprises a first end portion configured to be in fluidic communication with a reservoir configured to contain fluid and a second end portion configured to be in fluidic communication with a second location on or within the recipient's body and spaced from the first location. The fixation bracket and the elongate fluid conduit are configured to be implanted on or within the recipient's body prior to the reservoir being in fluidic communication with the first end portion.
Implementations are described herein in conjunction with the accompanying drawings, in which:
Sensorineural hearing loss (SNHL) is a permanent hearing loss due to damage that prevents or weakens nerve signals transmitted to the brain. Severe to profound SNHL can be addressed by a cochlear implant auditory prosthesis, while less severe SNHL can be addressed by an auditory prosthesis comprising a middle ear implant in contact with one of the ossicles of the ear, since patients with less severe SNHL can have a middle ear ossicular chain that is intact (e.g., capable of moving freely; not being blocked or having excessive conductive loss). Such middle ear implants follow the general practice of not removing functioning parts of the body unless necessary, and can be more effective for addressing less severe SNHL than are hearing aids or auditory prostheses using bone-anchored implants.
Conductive hearing loss (CHL) is due to obstruction or damage to the outer ear or middle ear that prevents sound from being conducted to the inner ear. CHL can be addressed by an auditory prosthesis comprising a bone-anchored hearing aid that transmits sound vibrations to travel through the skull bone to the inner ear, thereby bypassing the middle ear ossicles and tympanic membrane. Such bone-anchored hearing aids can be more effective for many CHL patients than are hearing aids that are positioned within the ear canal (e.g., which can utilize large amplification levels which can result in feedback issues).
Mixed hearing loss (MHL) is any combination of SNHL and CHL and can be addressed by an auditory prosthesis comprising a bone-anchored hearing aid or comprising a middle ear implant (e.g., to address the SNHL component). However, in contrast to addressing solely SNHL, addressing MHL can comprise removal and replacement or bypass (e.g., by extension or prosthesis) of part of the ossicular chain to address the CHL component.
Certain implementations described herein provide an adjustable (e.g., sliding; threaded; screw-like) extension configured to be implanted and mechanically coupled to a target location before an active component (e.g., transducer and/or reservoir) of a medical implant assembly is implanted. The extension can be mechanically coupled to the target location before being mechanically coupled to the active component. Certain such implementations reduce the number of components to be manipulated (e.g., positioned) by the practitioner performing the implantation and/or provides the practitioner with improved (e.g., maximum) visibility to the target location, thereby facilitating increased speed, increased ease, reduced risk of failure and/or damage to the implant and/or target location, and more consistent and reliable outcomes (e.g., successful coupling between the implant and the target location).
Certain implementations described herein include vibration isolation configured to prevent actuator vibrations from reaching the target location via other pathways separate from the extension. Certain such implementations provide more effective vibration and prevention of parallel vibration paths to the target location (e.g., canalizing the vibrations to the target location), thus preventing harmonic distortions (e.g., for high-power transducers for stimulating a high impedance stimulation target, such as the otic capsule, in a two-point fixation configuration), for more efficient stimulation and improved sound quality.
The teachings detailed herein are applicable, in at least some implementations, to any type of auditory prosthesis utilizing an implantable transducer assembly including but not limited to: electro-acoustic electrical/acoustic systems, cochlear implant devices, implantable hearing aid devices, middle ear implant devices, bone conduction devices (e.g., active bone conduction devices; passive bone conduction devices, percutaneous bone conduction devices; transcutaneous bone conduction devices), Direct Acoustic Cochlear Implant (DACI), middle ear transducer (MET), electro-acoustic implant devices, other types of auditory prosthesis devices, and/or combinations or variations thereof, or any other suitable hearing prosthesis system with or without one or more external components. Implementations can include any type of auditory prosthesis that can utilize the teachings detailed herein and/or variations thereof. Certain such implementations can be referred to as “partially implantable,” “semi-implantable,” “mostly implantable,” “fully implantable,” or “totally implantable” auditory prostheses. In some implementations, the teachings detailed herein and/or variations thereof can be utilized in other types of prostheses beyond auditory prostheses.
As shown in
As shown in
The power source of the external component 142 is configured to provide power to the auditory prosthesis 100, where the auditory prosthesis 100 includes a battery (e.g., located in the internal component 144, or disposed in a separate implanted location) that is recharged by the power provided from the external component 142 (e.g., via a transcutaneous energy transfer link). The transcutaneous energy transfer link is used to transfer power and/or data to the internal component 144 of the auditory prosthesis 100. Various types of energy transfer, such as infrared (IR), electromagnetic, capacitive, and inductive transfer, may be used to transfer the power and/or data from the external component 142 to the internal component 144. During operation of the auditory prosthesis 100, the power stored by the rechargeable battery is distributed to the various other implanted components as needed.
The internal component 144 comprises an internal receiver unit 132, a stimulator unit 120, and an elongate electrode assembly 118. In some implementations, the internal receiver unit 132 and the stimulator unit 120 are hermetically sealed within a biocompatible housing. The internal receiver unit 132 comprises an internal coil 136 (e.g., a wire antenna coil comprising multiple turns of electrically insulated single-strand or multi-strand platinum or gold wire), and preferably, a magnet (also not shown) fixed relative to the internal coil 136. The internal receiver unit 132 and the stimulator unit 120 are hermetically sealed within a biocompatible housing, sometimes collectively referred to as a stimulator/receiver unit. The internal coil 136 receives power and/or data signals from the external coil 130 via a transcutaneous energy transfer link (e.g., an inductive RF link). The stimulator unit 120 generates electrical stimulation signals based on the data signals, and the stimulation signals are delivered to the recipient via the elongate electrode assembly 118.
The elongate electrode assembly 118 has a proximal end connected to the stimulator unit 120, and a distal end implanted in the cochlea 140. The electrode assembly 118 extends from the stimulator unit 120 to the cochlea 140 through the mastoid bone 119. In some implementations, the electrode assembly 118 may be implanted at least in the basal region 116, and sometimes further. For example, the electrode assembly 118 may extend towards apical end of cochlea 140, referred to as cochlea apex 134. In certain circumstances, the electrode assembly 118 may be inserted into the cochlea 140 via a cochleostomy 122. In other circumstances, a cochleostomy may be formed through the round window 121, the oval window 112, the promontory 123, or through an apical turn 147 of the cochlea 140.
The elongate electrode assembly 118 comprises a longitudinally aligned and distally extending array 146 of electrodes or contacts 148, sometimes referred to as electrode or contact array 146 herein, disposed along a length thereof. Although the electrode array 146 can be disposed on the electrode assembly 118, in most practical applications, the electrode array 146 is integrated into the electrode assembly 118 (e.g., the electrode array 146 is disposed in the electrode assembly 118). As noted, the stimulator unit 120 generates stimulation signals which are applied by the electrodes 148 to the cochlea 140, thereby stimulating the auditory nerve 114.
While
For the example auditory prosthesis 200 shown in
The actuator 210 of the example auditory prosthesis 200 shown in
During normal operation, ambient acoustic signals (e.g., ambient sound) impinge on the recipient's tissue and are received transcutaneously at the microphone assembly 206. Upon receipt of the transcutaneous signals, a signal processor within the implantable assembly 202 processes the signals to provide a processed audio drive signal via wire 208 to the actuator 210. As will be appreciated, the signal processor may utilize digital processing techniques to provide frequency shaping, amplification, compression, and other signal conditioning, including conditioning based on recipient-specific fitting parameters. The audio drive signal causes the actuator 210 to transmit vibrations at acoustic frequencies to the connection apparatus 216 to affect the desired sound sensation via mechanical stimulation of the incus 109 of the recipient.
The subcutaneously implantable microphone assembly 202 is configured to respond to auditory signals (e.g., sound; pressure variations in an audible frequency range) by generating output signals (e.g., electrical signals; optical signals; electromagnetic signals) indicative of the auditory signals received by the microphone assembly 202, and these output signals are used by the auditory prosthesis 100, 200 to generate stimulation signals which are provided to the recipient's auditory system. To compensate for the decreased acoustic signal strength reaching the microphone assembly 202 by virtue of being implanted, the diaphragm of an implantable microphone assembly 202 can be configured to provide higher sensitivity than are external non-implantable microphone assemblies. For example, the diaphragm of an implantable microphone assembly 202 can be configured to be more robust and/or larger than diaphragms for external non-implantable microphone assemblies.
The example auditory prostheses 100 shown in
The transducer assembly 300 further includes a linear motion mechanism (not shown) (e.g., z-adjustment microdrive and compression unit) that is configured to mechanically couple the transducer 320 to the fixation element 310 and to controllably adjust a linear position (e.g., depth) of the transducer 320 (denoted in
The first end 332 of the connection apparatus 330 (e.g., connection apparatus 216) can comprise a solid first rod extending from a front portion of the transducer 320 and a hollow tube welded onto the first rod, forming a blind hole (e.g., 2 millimeters deep) configured to receive a first end of a solid second rod, the second rod comprising a second end that is the second end 334 of the connection apparatus 330. During an implantation process for the transducer assembly 300, the transducer 320 is positioned (e.g., at a depth selected to avoid the transducer 320 from contacting or being interfered by other bone portions 308 of the skull 304). A length measurement is made (e.g., using a template device) to determine a distance between the transducer 320 and the middle ear target (e.g., a distance between an inner surface of the blind hole of the transducer 320 into which the first end of the second rod is to be inserted), and the second rod is cut to an appropriate length using a cutting tool (e.g., on the operating room table), after which the first end of the second rod is positioned and affixed to the transducer 320 (e.g., the blind hole crimped onto the first end of the second rod), the transducer 320 is inserted and fixed to the fixation element 310, and the second end of the second rod is attached to the middle ear target. This process risks errors with the handling, cutting, and positioning of the second rod. Using connection apparatus 330 with pre-fixed lengths (e.g., a “one size fits all”) may not be recommended as adequate statistical data of the middle ear variability would be required and would result in design compromises. In addition, a pre-fixed connection apparatus 330 would be logistically complex to accommodate for the middle ear coupling variant options.
As described above, in the two-point fixation concept as schematically illustrated in
The example apparatus 500 shown in
In certain implementations, the first portion 510 comprises a fixture 512 (e.g., fixation bracket) configured to be affixed at the first location 502 (e.g., to a surface 513 of a skull bone 514 of the recipient's body). For example, as schematically illustrated by
In certain implementations, the second portion 520 comprises an orifice 522 and an elongate element 524 extending through the orifice 522 and configured to be in mechanical communication with the second location 504. The elongate element 524 of certain implementations comprises titanium or titanium alloy and can have a length in a range of 10 millimeters to 40 millimeters (e.g., in a range of 20 millimeters to 30 millimeters). As schematically illustrated by
In certain implementations, the elongate element 524 is configured to be moved (e.g., slid; screwed) within the orifice 522 to adjust the position of the elongate element 524 relative to the orifice 522 and/or the plate 523 (e.g., to adjust a distance that the elongate element 524 extends out of the orifice 522 towards the second location 504). For example, the elongate element 524 can be moved (e.g., slid; screwed) within the orifice 522 along a distance within a range of 0.1 millimeter to 25 millimeters (e.g., 0.1 millimeter to 1 millimeter). In certain implementations, the elongate element 524 is also configured to be tilted within the orifice 522 and/or bent to adjust the orientation (e.g., angle) of the elongate element 524 relative to the orifice 522 and/or the plate 523 (e.g., to adjust an angle at which the elongate element 524 extends out of the orifice 522 towards the second location 504).
The second portion 520 of certain implementations is configured to be mechanically coupled to a transducer 532. In
In
In certain implementations, the first portion 510 has a longitudinal axis 540 along which the first portion 510 extends at least partially through tissue at the first location 502 (e.g., the skull bone 514). As schematically illustrated by
In certain implementations, as schematically illustrated by
In certain other implementations in which the transducer 532 (e.g., microphone) receives mechanical vibrations (e.g., vibrational energy) that propagate along (e.g., through) the elongate element 524 from the second location 504, the mechanically compliant portion 610 is configured to substantially inhibit (e.g., prevent) other vibrations from other sources (e.g., body noise) from reaching the transducer 532. For example, the mechanically compliant portion 610 can be used with a fully implantable system comprising an implantable microphone and can be configured to inhibit (e.g., prevent) alternative vibration paths to the cochlea 140 and/or a feedback path to the implanted microphone. Certain implementations comprise both an actuator and a microphone seated in the same apparatus 600 with both the actuator and the microphone sufficiently vibrationally isolated from one another.
As schematically illustrated by
In
In certain implementations, the method 700 comprises drilling a channel 516 through a portion of the bone tissue (e.g., skull bone 514), the channel 516 extending from a top surface (e.g., surface 513) of the bone tissue.
In an operational block 710, the method 700 comprises at least partially implanting an assembly on or within a recipient's body. As schematically illustrated by
In certain implementations, at least partially implanting the assembly further comprises affixing the second portion 520 to the first portion 510. For example, as schematically illustrated in
In certain implementations, the elongate element 524 is initially separate from the orifice 522 and is configured to be inserted within the orifice 522 after the plate 533 or other component comprising the orifice 522 has been affixed to the first portion 510 or while the plate 533 is in the process of being affixed to the first portion 510. In certain other implementations, the elongate element 524 is inserted within the orifice 522 prior to the process of affixing the plate 533 or other component comprising the orifice 522 to the first portion 510.
In an operational block 720, the method 700 further comprises, while the first portion 510 is affixed to the first location 502, adjusting the second portion 520 (e.g., adjusting a position and/or orientation of the second portion 520) to be in operative communication with the second location 504 of the recipient's body. For example, adjusting the second portion 520 can be performed after the first portion 510 has been affixed to the first location 502, while the first portion 510 is in the process of being affixed to the first location 502, after the second portion 520 has been affixed to the first portion 510, or while the second portion 520 is in the process of being affixed to the first portion 510. In certain implementations in which the second portion 520 is initially separate from the first portion 510, adjusting the second portion 520 can be performed prior to affixing the second portion 520 to the first portion 510.
In certain implementations, as schematically illustrated by
In certain implementations, adjusting the second portion 520 further comprises affixing the elongate element 524 to the component comprising the orifice 522 such that the second portion 520 is no longer adjustable relative to the orifice 522. For example, one or both of the elongate element 524 and the component comprising the orifice 522 can be crimped or otherwise mechanically deformed and/or affixed to one another by adhesive.
In certain implementations, as schematically illustrated by
In an operational block 730, the method 700 further comprises, while the second portion 520 is in operative communication with the second location 504 of the recipient's body, operatively coupling (e.g., directly or indirectly) the second portion 520 with a third portion 530 of the assembly (e.g., a transducer 532 and/or a reservoir 534 configured to contain fluid). For example, operatively coupling the second portion 520 with the third portion 530 can be performed after the second portion 520 has been placed in operative communication with the second location 504 or while the second portion 520 is in the process of being placed in operative communication with the second location 504. In certain implementations, operatively coupling the second portion 520 with the third portion 530 comprises affixing the third portion 530 to the first portion 510 and/or the second portion 520 (e.g., by crimping or otherwise mechanically deforming one or more of the first portion 510, second portion 520, and third portion 530; using mating portions of the third portion 530 with mating portions of the first portion 510 and/or the second portion 520 and/or other fixation elements, such as screws and/or adhesive applied to one or more of the first portion 510, second portion 520, and third portion 530) such that the third portion 530 is in mechanical communication with the second portion 520. For example, a transducer 532 of the third portion 530 can be affixed to the proximal end of the elongate element 524 (e.g., rod 525a; wire 525c) or to a component comprising the orifice 522 that is affixed to the elongate element 524. For another example, a reservoir 534 of the third portion 530 can be affixed to the proximal end of the elongate element 524 (e.g., fluid conduit 525b) such that the reservoir 534 is in fluidic communication with the second portion 520 (e.g., and with the second location 504).
Certain implementations described herein provide simplified implantation procedures and/or tools, thereby reducing the probability of errors or mishaps during the assembly implantation process resulting from the handling, cutting, and positioning of the elongate element 524 between the transducer and sensitive structures of the recipient's body. For example, the manipulation of the elongate element 524 is reduced, thereby reducing the risk of losing or damaging the elongate element 524, as well as the risk of measuring or cutting errors.
Certain implementations described herein enable various extension coupling variant options without logical complexity. For example, an elongate element 524 can be pre-slid into the assembly, but the elongate element 524 can be easily replaced in the operating room by another elongate element if desired. Certain implementations described herein enable similar surgical procedures and configurations to be used for assemblies configured to address SNHL and assemblies configured to address MHL, thereby resulting in more consistent surgeries for a wider range of surgeons and more consistent outcomes.
Certain implementations described herein reduce the risk of mechanical interference (e.g., contact between the assembly and surrounding bone) by having only the elongate element 524 linearly translated into position, prior to the transducer 532 being implanted. In addition, assemblies of certain implementations described herein do not include a linear motion mechanism (e.g., z-direction microdrive and compression unit) for moving the transducer 532, thereby reducing complexity and expense (e.g., only including an axial rotational degree of freedom).
Certain implementations described herein provide simplification of the surgical process of implantation, reduce logistic complexity, and are applicable to all extension coupling variant options. By having the elongate element 524 extend downwards (e.g., into the cochleovestibular region) instead of the transducer 532, certain implementations reduce the risk of mechanical interference (e.g., inadvertent contact) of the actuator with the inner surfaces of the channel 516.
Although commonly used terms are used to describe the systems and methods of certain implementations for ease of understanding, these terms are used herein to have their broadest reasonable interpretations. Although various aspects of the disclosure are described with regard to illustrative examples and implementations, the disclosed examples and implementations should not be construed as limiting. Conditional language, such as, among others, “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain implementations include, while other implementations do not include, certain features, elements and/or steps. Thus, such conditional language is not generally intended to imply that features, elements and/or steps are in any way required for one or more implementations or that one or more implementations necessarily include logic for deciding, with or without user input or prompting, whether these features, elements and/or steps are included or are to be performed in any particular implementation. In particular, the terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced.
It is to be appreciated that the implementations disclosed herein are not mutually exclusive and may be combined with one another in various arrangements. In addition, although the disclosed methods and apparatuses have largely been described in the context of conventional cochlear implants, various implementations described herein can be incorporated in a variety of other suitable devices, methods, and contexts. More generally, as can be appreciated, certain implementations described herein can be used in a variety of implantable medical device contexts that can benefit from having at least a portion of the received power available for use by the implanted device during time periods in which the at least one power storage device of the implanted device unable to provide electrical power for operation of the implantable medical device.
Language of degree, as used herein, such as the terms “approximately,” “about,” “generally,” and “substantially,” represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms “approximately,” “about,” “generally,” and “substantially” may refer to an amount that is within ±10% of, within ±5% of, within ±2% of, within ±1% of, or within ±0.1% of the stated amount. As another example, the terms “generally parallel” and “substantially parallel” refer to a value, amount, or characteristic that departs from exactly parallel by ±10 degrees, by ±5 degrees, by ±2 degrees, by ±1 degree, or by ±0.1 degree, and the terms “generally perpendicular” and “substantially perpendicular” refer to a value, amount, or characteristic that departs from exactly perpendicular by ±10 degrees, by ±5 degrees, by ±2 degrees, by ±1 degree, or by ±0.1 degree. The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” less than,” “between,” and the like includes the number recited. As used herein, the meaning of “a,” “an,” and “said” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “into” and “on,” unless the context clearly dictates otherwise.
While the methods and systems are discussed herein in terms of elements labeled by ordinal adjectives (e.g., first, second, etc.), the ordinal adjective are used merely as labels to distinguish one element from another (e.g., one signal from another or one circuit from one another), and the ordinal adjective is not used to denote an order of these elements or of their use.
The invention described and claimed herein is not to be limited in scope by the specific example implementations herein disclosed, since these implementations are intended as illustrations, and not limitations, of several aspects of the invention. Any equivalent implementations are intended to be within the scope of this invention. Indeed, various modifications of the invention in form and detail, in addition to those shown and described herein, will become apparent to those skilled in the art from the foregoing description. Such modifications are also intended to fall within the scope of the claims. The breadth and scope of the invention should not be limited by any of the example implementations disclosed herein, but should be defined only in accordance with the claims and their equivalents.
Filing Document | Filing Date | Country | Kind |
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PCT/IB2021/062349 | 12/27/2021 | WO |
Number | Date | Country | |
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63133598 | Jan 2021 | US |