Bone-anchored hearing aid components and kits

Abstract

A bone-anchored hearing aid assembly is provided, comprising: an implantable anchor shaft including an axial lumen extending through the implantable anchor shaft and configured to be fixed within a drilled hole in the skull of a subject; and a removable stimulation unit shaped to be received within the axial lumen of the anchor shaft; wherein the anchor shaft and the stimulation unit are configured to detachably attach the stimulation unit within the axial lumen of the anchor shaft; and wherein the removable stimulation unit includes a reciprocating end effector through a bottom hole at a distal end of the removable stimulation unit, the end effector being configured and controllably actuated to perform reciprocating movement along a main longitudinal axis of the removable stimulation unit for mechanically transmitting vibrations to the cochlear wall of a subject for perception as sound by the subject.

Description

Technical Field

[0001] This disclosure relates generally to hearing aids, and more specifically to bone-anchored hearing aids.

[0002] background Various implantable hearing devices have been developed to address different types and degrees of hearing loss. These devices are generally divided into three main categories: cochlear implants, middle ear implants, and bone-anchored hearing aids. Each of these technologies utilizes a unique approach to sound processing and transmission, tailored to specific anatomy and hearing loss conditions.

[0003] Cochlear implants are designed for individuals with severe to profound sensorineural hearing loss, where the hair cells in the cochlea are damaged or absent. Unlike traditional hearing aids that amplify sound, cochlear implants bypass the damaged cochlea and directly stimulate the auditory nerve with electrical signals. A sound processor captures the sound and converts it into digital signals. These signals are transmitted to the implant, an array of electrodes inserted into the cochlea, which then delivers the electrical stimulation to the auditory nerve fibers.

[0004] On the other hand, middle ear implants are designed for individuals with mild to moderate sensorineural hearing loss or mixed hearing loss, such as those who have undergone radical mastoidectomy (in which the ossicles are removed). These devices work by converting sound into mechanical vibrations that are transmitted directly to the ossicles in the middle ear. This method amplifies the sound and improves sound transmission to the inner ear. Some middle ear implants operate by vibrating the oval or round window membrane, thus bypassing the ossicles. However, the implantation of most middle ear implants requires complex and delicate surgery, which limits their use. Furthermore, active middle ear disease can hinder the implantation of such a device in a patient, and subsequent middle ear infections in patients with existing implants may impair device function and require removal. In addition, these implants are limited in achieving sufficient gain.

[0005] WO 2014 / 030159, assigned to the assignee of this application, describes a hearing aid device comprising: a deformable member configured to contract and expand along a deformation axis between a first side and a second side in response to an applied external field; and a fastening assembly configured to carry the deformable member to provide rigid coupling between the first and second sides of the deformable member and bone tissue near the cochlea, such that the contraction and expansion of the deformable member directly stimulates vibration of the cochlear wall.

[0006] In implantable middle ear hearing aids that may require removal or replacement, the opening in the skull is typically sealed by repositioning the removed bone fragments and then covering it with scalp. Over time, the bone usually heals and reintegrates seamlessly, so additional surgical intervention may be needed to fit the new hearing aid. This may require reopening the healed bone, similar to performing a subsequent craniotomy. The necessity of this surgery depends on the type of implant and the patient's unique circumstances.

[0007] Overview There is a need in the art for a novel method for implantable hearing aid devices that allows for easy and safe implantation and removal of the hearing aid device from the skull, and, when needed, reinstallation or replacement of one or more parts of the device without additional skull drilling, while making the procedure less complicated.

[0008] This disclosure provides a bone-anchored hearing aid device / assembly that utilizes a permanent, reusable cranial entry port (hereinafter referred to as an "anchoring shaft" or "external screw"), wherein a hearing aid (or at least a portion thereof) coupled within a removable stimulator unit (hereinafter sometimes referred to as an "internal screw") can be reinstalled or replaced with a new hearing aid. This could be for reasons such as the end effector becoming too short, the stimulator unit malfunctioning / breaking down, or the need to replace it with a device featuring a new design or actuator model. This configuration allows for precise control of the axial positioning of the implanted hearing aid device, for example, adjusting the axial positioning due to possible variations in the distance from the cochlear wall to the skull, and for increasing or decreasing the force exerted on the bone by the removable stimulator unit when mounted in the anchoring shaft.

[0009] It should be noted that the implant of the device disclosed herein advantageously avoids any functional damage to the middle ear structures and can be easily removed when the original middle ear function is restored, if necessary.

[0010] When the hearing aid device is removed from the access port (e.g., temporarily), the stimulation unit is replaced with an inner screw plug, and the access port can be covered by a scalp portion. The access port can then be easily accessed for reinstallation by simply removing or tapping the scalp portion covering the access port and removing the screw plug, thus avoiding the need for additional drilling after the initial procedure.

[0011] Therefore, the bone-anchored hearing aid device of this disclosure combines durability, flexibility and precision, providing a reliable solution for repeated skull entry while maintaining the structural integrity of the bone and surrounding tissues.

[0012] Bone-anchored hearing aid assembly (for simplicity, it is sometimes referred to as "bone anchor" in this article) Components The device includes a hollow anchor shaft (forming a reusable access port) and a removable / replaceable stimulation unit. The hollow anchor shaft is adapted to be implanted in a borehole drilled into the skull of a subject. The removable / replaceable stimulation unit is sized and shaped to be housed within the hollow anchor shaft and detachably attached to the hollow anchor shaft.

[0013] The stimulation unit is configured to directly stimulate the cochlear wall (i.e., the lateral semicircular canal portion of the cochlea). To this end, the stimulation unit utilizes a controllably actuated reciprocating end effector to mechanically transmit vibrations to the cochlear wall, thereby causing movement of perilymph and resulting in hearing.

[0014] In the following description, the hollow anchoring shaft is sometimes referred to as the “outer screw.” Furthermore, in the following description, the stimulation unit detachably attached to the interior of the hollow anchoring shaft is sometimes referred to as the “inner screw.” However, it should be noted that the principles of this disclosure are not limited to this particular embodiment of the hearing aid assembly, and the detachable attachment between the hollow anchoring shaft and the stimulation unit located within it can utilize any suitable mechanism.

[0015] Therefore, according to a broad aspect of this disclosure, a bone-anchored hearing aid assembly is provided, comprising: an implantable anchor shaft including an axial lumen extending therethrough and configured to be fixed within a drilled hole in the skull of a subject; a removable stimulating unit shaped to be received within the axial lumen of the anchor shaft; wherein the anchor shaft and the stimulating unit are configured to detachably attach the stimulating unit within the axial lumen of the anchor shaft to the anchor shaft; and wherein the removable stimulating unit includes a reciprocating end effector through a bottom hole at the distal end of the removable stimulating unit, the end effector being configured and controllably actuated to perform reciprocating movement along a main longitudinal axis of the removable stimulating unit for mechanically transmitting vibrations to the cochlear wall of the subject for perception as sound by the subject.

[0016] In some embodiments, the removable stimulation unit and the implantable anchor shaft are configured such that when the removable stimulation unit is housed in the implantable anchor shaft, the distal portion of the removable stimulation unit extends from the bottom surface of the implantable anchor shaft.

[0017] In some embodiments, a lid cover may be provided, configured to seal against an opening on the top surface of the removable stimulation unit. Optionally, the lid cover may be configured with a pass-through bore, which serves as a working channel for allowing additional elements to pass through or be attached to additional elements.

[0018] The cover may also have one or more recesses configured to receive input from an external tool to insert the removable stimulation unit into the implantable anchoring shaft (e.g., to a selected depth). The one or more recesses may define various geometries, such as cross-shaped or concave hexagonal.

[0019] In some embodiments, the removable stimulation unit includes at least one internal tubular cavity configured as a working channel for allowing an attachment element to pass through or engage with the attachment element. For example, the working channel can be used to insert an optical imaging device to visualize the insertion and adjustment procedure. The working channel can be closed by a corresponding screw or other plug after the procedure is completed and can be reopened when needed.

[0020] Optionally, the cover may include a through-hole connecting to the internal tubular cavity of the removable stimulation unit. For example, a working channel may be configured to allow wires connected to one or more microphones located in the middle ear cavity to pass through. One or more microphones may be inserted into the middle ear cavity, with wires feeding external electronics through the stimulation unit (via the working channel). The one or more microphones may be used to sense sounds in the middle ear, or to sense the user's vocal cord sounds and blood pulse sounds so that they can be filtered out. The electronics may be located outside the skull, subcutaneously under the scalp, or in a socket formed in the bone and covered by the skull.

[0021] The removable stimulation unit includes at least one actuator operatively coupled to an end effector for driving the end effector to perform reciprocating movement along the stimulation unit.

[0022] In some embodiments, the actuator may include or be configured as a piezoelectric element (e.g., a piezoelectric stacked actuator, a piezoelectric bending actuator), or may include or be configured as an electromagnetic transducer. In some embodiments, at least one actuator may be housed within a stimulation unit. For example, a removable stimulation unit includes a first cavity for housing at least one actuator and a channel extending between the first cavity and a bottom aperture, such that an end effector performs reciprocating movement along the channel to interact with a target intracranial surface, i.e., interacting with the cochlear wall via the bottom aperture in the stimulation unit. The actuator is housed in the first cavity between the end effector and the top surface of the stimulation unit (e.g., between the end effector and the cap).

[0023] In some other embodiments, the actuator (e.g., a bending actuator) may be located externally to the assembly, mounted in a suitably formed fossa in the skull near the borehole. In this case, the channel extends between the top and bottom boreholes. The bending actuator is coupled to the end effector via the top borehole fabricated in the stimulation unit; that is, one end of the actuator is rigidly attached to the skull within the fossa, and the other end pushes against the end effector. In some embodiments, the external actuator may be housed within a housing located in the fossa, extending toward the stimulation unit to connect to the end effector. In operation, the bending actuator operates the end effector such that it applies a force (e.g., vibration) to the target cochlear wall via the end effector. A constant DC bias may be applied to the bending actuator to provide optimal preload.

[0024] For example, the end effector can be in the form of a rigid rod that is coupled to the actuator through its proximal end and interacts with the cochlear wall through its free, opposite distal end.

[0025] In some embodiments, the anchoring shaft is made of one or more biocompatible and / or MRI-compatible material components, such as, but not limited to, titanium alloys, platinum, platinum alloys, or polymers such as PEEK. The diameter of the anchoring shaft may be slightly smaller than the diameter of the borehole to allow the anchoring shaft to be advanced into and adhere to the borehole. Optionally, the hollow anchoring shaft may have threads on its outer / peripheral surface for screwing the hollow anchoring shaft into the borehole. The external threads may be external threads that can be processed to have a surface finish that will allow bone to attach to the anchoring shaft and promote osseointegration with the skull, thereby ensuring a stable and secure fit. In this case, the diameter of the borehole may be slightly smaller than the diameter of the anchoring shaft to screw the anchoring shaft into the borehole.

[0026] The removable stimulation unit includes at least one mounting feature on its outer surface, the at least one mounting feature being configured to engage with at least one corresponding mating feature on the inner surface of the implantable anchoring shaft, such that the mounting feature forms a detachable attachment.

[0027] In some embodiments, the detachable attachment of the stimulation unit to the anchor shaft can be via a threaded engagement between the stimulation unit and the anchor shaft. For this purpose, the anchor shaft has a threaded portion on its inner circumferential surface, and the stimulation unit has a corresponding threaded portion on its outer circumferential surface. In possible embodiments, the internal thread of the anchor shaft and the external thread of the stimulation unit may be treated to reduce friction and stress on the external thread of the anchor shaft when the stimulation unit is screwed into it.

[0028] The outer surfaces of the screw stimulation unit and the end effector can be treated with a coating (such as a SiN or diamond-like carbon (DLC) coating) that inhibits tissue adhesion. Remember that bone tissue may regrow to close the borehole after implantation; this coating allows the end effector to move axially (reciprocating / displacement) and enables the entire stimulation unit to be removed or replaced.

[0029] the term" Top, upper and proximal "as well as" Bottom, lower part and far end "Throughout this disclosure, the terms '...' are used to denote the relative position and / or orientation of different features and / or surfaces of components relative to the inner ear of a subject. In particular, the term '...'" Top, Upper Part and proximal end "" indicates the location of the scalp closer to the subject's head; the term " Bottom, lower part and far end "In this article, it is used to indicate the location of the inner ear that is closer to the subject."

[0030] The stimulation unit may be provided with a flexible member configured and arranged to hold the end effector along the axis of movement (i.e., along the stimulation unit) during reciprocating motion. Typically, the flexible member is fixedly attached to the stimulation unit and appropriately coupled in a fluid-tight manner to a portion of the circumference of the end effector, such that the end effector protrudes beyond the flexible member. Thus, the flexibility of the flexible member allows for reciprocating motion of the end effector. This fluid-tight coupling / attachment of the flexible member to the stimulation unit and the end effector allows for the desired reciprocating motion of the end effector while preventing fluid from entering the stimulation unit from inside the skull.

[0031] In some embodiments, the removable stimulation unit includes a cavity (sometimes referred to as a "second cavity"), and a flexible member is fixedly coupled (e.g., via its periphery) to at least one surface defined by the cavity. For example, such a flexible member may include a diaphragm or be in the form of a diaphragm. As will be described in further detail below, such a flexible member has a dome-shaped or corrugated and / or stretchable configuration.

[0032] When the stimulation unit uses an internal actuator, the end effector extends / moves along a channel extending between the first and second cavities. When the stimulation unit uses an external actuator, the end effector moves along a channel extending between the top aperture and the second cavity.

[0033] In some embodiments, the flexible member is configured as an O-ring, which is positioned within the bottom portion of the removable stimulation unit.

[0034] In some embodiments, the flexible member is configured as a flexible polymer film that is attached to the outer surface of the stimulation unit around the bottom hole of the stimulation unit.

[0035] As described above, in some embodiments, the surface of the end effector and one or more surfaces of the cover may be coated with, for example, SiN or diamond-like carbon (DLC) to minimize tissue adhesion to the surface of the end effector and one or more surfaces of the cover, or to inhibit tissue adhesion to these surfaces, and to allow the end effector to move freely if tissue grows around it.

[0036] In some embodiments, a spring may be used, mounted in the stimulation unit such that its contraction / expansion axis extends along the actuation / movement axis of the end effector, to compensate for the skull-to-cochlear distance due to skull growth or torsion. Skull torsion may occur with age or due to forces applied during component operation. The spring may be connected at one end to a cover that is hermetically fitted (e.g., via threading) in a top hole of the stimulation unit, or it may be stopped solely by the cover proximal to the spring, and the spring may be connected to or interact only with the actuator via its opposite ends. In other words, the spring is closed at its opposite ends between the cover and the actuator. For example, consider using a piezoelectric element in the actuator, where the end effector applies force to the target cochlear wall as the actuator expands or contracts along the actuation axis. Compensation for the skull-to-cochlear distance due to skull growth or torsion can also be achieved by attaching the end of the spring to the cover, by screwing the cover in while maintaining the required force against the target cochlear wall.

[0037] In some embodiments, the upper surface of the implantable anchor shaft includes a plurality of spaced-apart openings configured to receive input from an external tool to insert the implantable anchor shaft into a borehole drilled into the subject's skull.

[0038] In some embodiments, the top surface of the removable stimulation unit includes one or more recesses configured to receive input from an external tool to insert the removable stimulation unit into a selected depth within an implantable anchoring shaft.

[0039] One or more electronic circuits / modules may be located externally to the component and configured to establish signal communication with the stimulation unit wirelessly and / or via subcutaneous wires (not shown) passing through one or more openings of the stimulation unit. If the electronic circuitry is too bulky, it may be housed within a fossa / recess formed in the mastoid portion of the skull or temporal bone. The electronic circuitry can be used to record data and relay signals to the stimulation unit (and relay signals from a microphone, if used), and can also be used to transmit or receive data / signals to or from external devices via RF and / or optical and / or acoustic devices. Connection of the subcutaneous electronic circuitry to the stimulation unit can be made using a pre-wiring option. The electronic circuitry and the stimulation unit may be pre-wired together or connected via a suitable connector of the subcutaneous electronic circuitry. For example, such electronic circuitry may include a power source or be connected to a power source, such as a rechargeable battery with an RF device for charging the battery from outside the subject's body.

[0040] In some embodiments, the anchor shaft includes a central cavity and is configured to house an angular displacement unit within the cavity, the angular displacement unit being configured to perform angular displacement relative to the implantable anchor shaft.

[0041] In some embodiments, an axial cavity is formed in an angular displacement unit, the central cavity having an inner circumferential concave surface that faces a substantially matching outer circumferential convex surface of the angular displacement unit when the angular displacement unit is housed in an implantable anchor shaft, thereby enabling adjustable orientation of the angular displacement unit relative to the anchor shaft.

[0042] The implantable anchor and / or the implantable anchor shaft has a fixing mechanism configured to fix the angular displacement unit in a coaxial position relative to the implantable anchor shaft, in which the main longitudinal axis of the implantable anchor shaft coincides with the main longitudinal axis of the angular displacement unit.

[0043] For example, the angular displacement element may have a hole extending between its upper surface and its convex surface, and the implantable anchor shaft may have a corresponding hole extending from its concave surface. These holes are aligned in a coaxial position and configured to accommodate locking members within these holes, thereby locking the angular displacement element and the implantable anchor shaft in a coaxial position. However, it should be noted that this disclosure is not limited to this type of locking mechanism, and other mechanisms may be used to lock the angular displacement element and the implantable anchor shaft in a coaxial position.

[0044] The anchoring shaft may have a peripheral lip / flange extending laterally from the hollow shaft (e.g., from its top circumferential edge). This peripheral lip may adhere to the skull and / or may have multiple holes configured to receive screws to be screwed into the skull to secure the anchoring shaft to the skull. The stimulation unit and / or the anchoring shaft may have a surface covering / layer made of a material that prevents tissue adhesion, facilitating easy removal of tissue to allow access to the stimulation unit. The location and orientation of the borehole to be drilled can be determined using CT or other imaging techniques. As known in the art, after analyzing the location and orientation data, drilling can be performed using a prefabricated jig. This data can be further used to insert the stimulation unit into the anchoring shaft to a predetermined depth, allowing the end effector to reach the target site (i.e., the cochlear wall) and apply the desired force.

[0045] According to another broad aspect of this disclosure, a removable stimulation unit is provided for use in a bone-anchored hearing aid assembly, the removable stimulation unit being configured to be removably attached within an axial lumen of an implantable anchor shaft when the implantable anchor shaft is installed within a borehole drilled into the skull of a subject, wherein the removable stimulation unit has a bottom hole at its distal end and includes at least one actuator and a reciprocating end effector passing through the bottom hole, the end effector being configured to perform reciprocating movement along a main longitudinal axis of the removable stimulation unit to mechanically transmit vibrations to the cochlear wall of the subject for perception as sound by the subject, and the at least one actuator being operatively coupled to the end effector to drive the end effector to perform the reciprocating movement.

[0046] According to another broad aspect of this disclosure, a kit for assembling an implantable hearing aid for mechanically transmitting vibrations to the cochlea of ​​a subject is provided, the kit comprising: N (N≥1) removable stimulators, each removable stimulator configured as described above for detachably attaching to a predetermined anchor shaft implanted in a borehole in the skull of the subject; and one or more tools for inserting the removable stimulators into the implantable anchor shaft at a selected depth.

[0047] In some embodiments, the kit further includes one or more elements to be positioned within at least one working channel manufactured in the removable stimulation unit.

[0048] In some embodiments, the kit also includes at least one microphone to be mounted in the middle ear cavity. If a microphone is to be used, it is installed through the lumen / hole of the stimulation unit before insertion, with the wire passing through the working channel in the stimulation unit. In this case, the hole is large enough to accommodate the wire and the end effector.

[0049] According to another broad aspect of this disclosure, a kit for assembling an implantable hearing aid for mechanically transmitting vibrations to the cochlea of ​​a subject is provided. The kit includes: N (N≥1) anchor shafts, each configured for implantation into a borehole in the skull of a subject; M (M≥1) removable stimulation units, each configured as described above for detachably attaching to a selected anchor shaft when the anchor shaft is implanted into a borehole in the skull; one or more tools for inserting the implantable anchor shaft into a borehole drilled in the skull of the subject; and one or more tools for inserting a removable stimulation unit into a selected depth within the implantable anchor shaft. Brief description of the attached diagram To better understand the subject matter disclosed herein and to illustrate how it can be implemented in practice, embodiments will now be described by way of non-limiting example with reference to the accompanying drawings, in which: Figures 1A to 1C This is a schematic diagram of the bone-anchored hearing aid assembly disclosed herein, wherein, Figure 1A This is a cross-sectional view of the component. Figure 1B This is a side perspective view of the component, and Figure 1C This is a top-side 3D view of the component; Figure 2 It is a non-limiting cross-sectional view of a bone-anchored hearing aid assembly with an anchoring shaft having external threads; Figure 3 A top view schematically illustrates a specific, non-limiting example of the configuration of a bone-anchored hearing aid component; Figure 4 A bottom view schematically illustrates a specific, non-limiting example of a bone-anchored hearing aid assembly of this disclosure; Figures 5A to 5C A specific, non-limiting example of the configuration of a bone-anchored hearing aid assembly with an actuator is schematically shown, wherein, Figure 5A An example of a component with an internal actuator is shown, and Figure 5B and Figure 5C An example is shown of an assembly with an externally located bender-type actuator; Figures 6A to 6C Cross-sectional views, top perspective views, and perspective views with some exploded parts are shown schematically, respectively, of specific non-limiting examples of the configuration of the assembly combining the cover lid and the spring. Figures 7A to 7C A cross-sectional view schematically illustrates a specific, non-limiting example of the configuration of a bone-anchored hearing aid assembly incorporating flexible components, wherein... Figure 7A A component with a diaphragm is shown, and Figure 7B and Figure 7CTwo examples of components with O-rings are shown; Figures 8A to 8D Different views schematically illustrate specific, non-limiting examples of the configuration of a bone-anchored hearing aid assembly with an angle adjustment unit; and Figure 9 This is a flowchart of an exemplary method for implanting / installing components.

[0051] Detailed description refer to Figures 1A to 1C The figures schematically illustrate cross-sectional, side, and top-side perspective views of a bone-anchored hearing aid assembly (generally designated 10) in an assembled state according to some embodiments of the present disclosure. As shown, assembly 10 includes an implantable anchor shaft 12 and a stimulation unit 14. The implantable anchor shaft 12 is configured to be fixed within a drilled hole in the skull of a subject, and the stimulation unit 14 is shaped and sized to be received and mounted within the anchor shaft 12. Assembly 10 is configured and operable to apply vibrations to the cochlear wall CW of the subject's cochlea C, to be perceived as sound by the subject.

[0052] The anchoring shaft 12 has a top opening 12t at the proximal end of the shaft 12, a bottom opening 12b at the distal end of the shaft 12, and an axial lumen 12x extending along the length of the anchoring shaft 12 between the top opening and the bottom opening. The stimulation unit 14 is received and mounted within the lumen 12x such that the stimulation unit 14 is detachably attached to the anchoring shaft 12 along the axial lumen of the anchoring shaft 12.

[0053] exist Figure 1A In a non-limiting example, the attachment of the stimulation unit 14 to the anchoring shaft 12 is via a screwing / threading mechanism. As shown, the anchoring shaft 12 has a thread 12h arranged along its inner circumferential surface (i.e., along the lumen), and the stimulation unit 14 has a thread 14h arranged along the length of its outer circumferential surface, and is configured to threadedly engage with the thread 12h to form a tight attachment between the stimulation unit 14 and the anchoring shaft 12 along the axial lumen of the anchoring shaft 12, allowing for disassembly when needed. Therefore, in this example, the anchoring shaft 12 and the stimulation unit 14 are configured as an external screw and an internal screw, respectively.

[0054] The stimulation unit 14 has a longitudinal internal channel (cavity) 14a and a bottom aperture 14b located at the distal end of the channel 14a. The stimulation unit 14 includes a reciprocating end effector 14e (typically in the form of an elongated rod) mounted in the channel 14a. The end effector 14e is controllably actuated to perform a reciprocating movement (e.g., in the range of 40 nm–100 nm) along the axis O of the channel (and thus the removable stimulation unit 14), as indicated by arrow D, thereby allowing the end effector to pass through its distal end through the bottom aperture 14b for mechanically transmitting vibrations to the cochlear wall CW for perception as sound by the subject. As will be further described below, the end effector 14e is attached to an actuator via its opposite proximal end, which actuates and controls the movement of the end effector.

[0055] Anchor shaft 12 can be secured within a borehole, for example, by adhering its outer surface 12e (i.e., its periphery / circumference) to the borehole. In some embodiments, anchor shaft 12 includes a circumferential top lip 12i configured to tightly attach anchor shaft 12 to the skull when anchor shaft 12 is in the borehole, thereby securing anchor shaft 12 within the borehole. Circumferential top lip 12i can be attached to the skull (not shown), for example, by adhesion. Alternatively or additionally, circumferential top lip 12i can be formed with a plurality of spaced-apart openings 12g configured to receive screws or bolts or similar tools to attach anchor shaft 12 to the skull.

[0056] For ease of explanation and understanding, the same reference numerals are used to indicate common functional components in all examples of this disclosure.

[0057] Figure 2 A cross-sectional view schematically illustrates a specific, non-limiting example of the bone-anchored hearing aid component 10 of this disclosure. In this example, the component is configured with... Figures 1A to 1C The configurations of the components are roughly similar, and Figure 2 An anchoring shaft 12 is illustrated with a thread 12h arranged along the length of its outer circumferential surface, such that the thread 12h can be threadedly engaged with a corresponding / corresponding thread (not shown) that may be formed in a drill hole in the bone.

[0058] refer to Figure 3The figures illustrate a top view of a specific, non-limiting example of the configuration of the bone-anchored hearing aid assembly 10 of this disclosure. In these figures, the assembly 10 is shown when it is implanted / installed in a drilled hole in the skull S of a subject. As shown, the anchoring shaft 12 may have at least one opening 12p formed on its top surface 12s, but in practice, multiple openings 12p, with four such openings 12p illustrated, for example, in a radially symmetrical manner, in these figures. The openings 12p are configured to receive input from an external tool (e.g., a four-pin wrench) to insert the anchoring shaft 12 into the drilled hole.

[0059] As described above, the anchoring shaft 12 may have threads arranged along the length of its outer circumferential surface. Figure 2 12h). Thus, when the anchoring shaft 12 is connected to the four-pin wrench via the opening 12p, the anchoring shaft 12 can be used to drill a hole in the skull, such that the thread 12h (in the middle) is threaded during drilling. Figure 2 The corresponding threads are formed in the drilled hole. Alternatively, the threads in the drilled hole can be formed with a suitable tool before the anchoring shaft 12 is inserted, so that the anchoring shaft 12 can be screwed into the drilled hole using a four-pin wrench.

[0060] In this example, the stimulation unit 14 has one or more recesses 14r formed on the top surface 14s of the stimulation unit 14 and configured to receive input from an external tool to insert the stimulation unit 14 into a selected depth within the implantable anchor shaft 12. In this example, the stimulation unit 14 has a cross-shaped recess.

[0061] refer to Figure 4 The diagram schematically shows a bottom view of a specific, non-limiting example of the bone-anchored hearing aid assembly 10 of this disclosure.

[0062] In this example, component 10 is shown implanted / installed in a drilled hole in the skull S of the subject, and the bottom / distal portion 14p of the stimulation unit 14 is shown protruding from the bottom opening (not visible here) of the anchoring shaft 12.

[0063] refer to Figures 5A to 5C The figures schematically illustrate specific, non-limiting examples of the configuration of component 10 of this disclosure. These figures more specifically illustrate possible housing arrangements for actuators used to controllably operate the reciprocating motion of an end effector.

[0064] exist Figure 5AIn the example, the stimulation unit 14 has an inner cavity 14c (referred to herein as the "first cavity" for further illustrative purposes), and an internal channel 14a accommodating the end effector extends between the first cavity 14c and a bottom aperture 14b. An actuator 14u (e.g., a piezoelectric or electromagnetic actuator) is accommodated within the first cavity 14c and operatively coupled to the end effector 14e. The end effector 14e is coupled to the actuator 14u via its proximal end, and the actuator 14u is controllably axially deformed, thereby causing the end effector to reciprocate axially within the channel 14a according to a predetermined movement pattern. This results in the end effector protruding through the bottom aperture 14b toward the cochlear wall and a corresponding pattern protruding onto the cochlear wall, thereby providing a desired pattern of interaction force between the end effector and the cochlear wall. This arrangement provides mechanically transmitted vibrations to the cochlear wall CW, which causes deformation of the cochlear wall and pushes the perilymph.

[0065] Figure 5B and Figure 5C An example is illustrated of a configuration of assembly 10 utilizing a piezoelectric bender actuator assembly 14u', which includes a bender actuator 16p operatively coupled to electronic circuitry 16v located outside assembly 10 (located within a socket 16' which may be formed outside (e.g., nearby) in the skull S), and also connected to the proximal / proximal portion of an end effector 14e. Figure 5B As shown, the stimulation unit 14 has an internal channel 14a extending between a top opening 14t (although not shown in the figure, as the actuator is shown as being mounted therein) and a bottom hole 14b, the top opening 14t being located on the top surface 14s of the stimulation unit 14. An end effector 14e extends along the channel 14a, and its proximal end is connected to the actuator via the top hole 14t on the top surface of the stimulation unit 14. Figure 5B In the example, the bender actuator 16p is anchored to electronic circuitry 16v at one end and is free to move on the other side / end to press against end effector 14e. Alternatively, the bender actuator 16p may be anchored to the skull at one end while electrically coupled to electronic circuitry 16v (e.g., via a wire) and free to move on the other side / end to press against end effector 14e.

[0066] Therefore, in these configurations, the end effector extends slightly from the stimulation unit through its proximal end via a top hole. In operation, the bender actuator 16p reciprocates in response to a voltage applied to the bender actuator 16p by the electronic circuit 16v.

[0067] As also illustrated in the figure, one or more recesses 14k may be formed on the top surface 14s of the stimulation unit 14, the one or more recesses 14k being configured to receive input from an external tool to insert the removable stimulation unit 14 into a selected depth within the anchoring shaft 12.

[0068] It should also be noted that... Figure 5A As illustrated, in some embodiments, an internal tubular cavity 14w may be formed along the stimulation unit 14 to serve as a working channel for the passage of additional elements / devices. For example, such a working channel may be used to advance the wires of one or more microphones into the middle ear.

[0069] refer to Figures 6A to 6C A cross-sectional view of exemplary component 10 is schematically shown. Figure 6A ), top-down 3D view ( Figure 6B ) and a three-dimensional drawing with some disassembled parts ( Figure 6C In this example, the configuration of the stimulation unit 14 is generally similar to that of the example described above with an internal actuator. The stimulation unit 14 has a removable cover 14l configured to open at the top of the stimulation unit 14 (see [link to example]). Figure 6C The 14t sealing fit. For example, this sealing fit can be achieved by threading / screwing the cover 14l into the top opening 14t.

[0070] A spring member 14n is also provided in the stimulation unit 14. This spring member 14n is located within the first cavity 14c and is arranged / accommodated such that its opposite ends are closed between the cover 14l and the actuator 14u. The spring member 14n can be coupled to or only contacts the cover 14l at one end, and connected to or only contacts the actuator 14u at its opposite ends. The spring member 14n can be used to adjust the preload of the actuator, or to further compensate for the natural variation in the distance from the skull to the cochlea by maintaining an effective force transmitted to the target surface (i.e., the cochlear wall) via the end effector 14e.

[0071] However, it should be noted (although not specifically shown) that the stimulation unit 14 may be provided with a cover 14l, regardless of whether a spring mechanism is used. The cover 14l may be inserted into a selected depth within the first cavity 14c, and / or may have a selected width to adjust the preload on the actuator 14u, for maintaining effective force on the target surface and compensating for the natural variation in the distance from the skull to the cochlea by changing the insertion depth.

[0072] like Figure 6B and Figure 6CAs shown, the cover 14l has an internal hollow working channel, the proximal end of which is shown as an opening 14g on the top surface 14z of the cover 14l. Typically, the cover 14l may have more than one such working channel. The working channel may be used, for example, to allow a subcutaneous wire or tube to pass through to the underside of the scalp or through the scalp.

[0073] Alternatively, as Figure 6B As shown, the socket 16 may be formed in the skull S outside of component 10 (e.g., near component 10). The socket 16 may be adapted to house electronic circuitry / modules (e.g., a power supply) capable of signal communication with component 10 (i.e., with its stimulation unit 14). This signal communication may be wireless and / or via a subcutaneous wire passing through an opening 14g in the stimulation unit 14. The electronic circuitry may be used to record data and relay data / signals to the stimulation unit 14. They may also be used to transmit data or receive data from external devices via RF and / or optical and / or acoustic devices; and may include a power supply and circuitry for charging it.

[0074] refer to Figure 7A and Figure 7B The diagram schematically illustrates a cross-sectional view of a specific non-limiting configuration of a bone-anchored hearing aid 10 according to another non-limiting example. In these examples, the stimulation unit 14 also includes a flexible member for maintaining the end effector on its axis of movement during reciprocating movement of the end effector. This flexible member is fluid-tightly attached to the stimulation unit while coupled to the circumference of the end effector 14e, such that the end effector protrudes beyond the flexible member. The reciprocating movement of the end effector 14e is permitted due to the axial flexibility of the flexible member. The flexible member can be made of any suitable biocompatible and MRI-compatible material, such as metal alloys or polymers.

[0075] In these examples, the stimulation unit 14 has a second inner cavity 14m extending from the bottom surface 14f of the stimulation unit 14. More specifically, the internal channel (which houses the end effector) has symmetrical protrusions formed in the portion forming the second inner cavity.

[0076] exist Figure 7A In the example, the flexible member is in the form of a generally dome-shaped diaphragm 14d, located within the second inner cavity 14m, such that the diaphragm is connected to the bottom surface 14f of the second inner cavity 14m through its periphery, while the diaphragm surrounds and is connected to the end effector in a fluid-tight manner through its inner surface. Therefore, the end effector 14e extends into the second inner cavity 14m such that the diaphragm 14d protrudes, allowing the end effector 14e to perform reciprocating movements. However, it should be noted that the diaphragm 14d can be a diaphragm of any shape, such as curved or corrugated.

[0077] With the actuator 14u located within the first cavity 14c, the end effector 14e passes through the channel 14a extending between the first cavity 14c and the second cavity 14m. If the stimulation unit uses an externally located actuator ( Figure 5B If 14u' is in the middle, then channel 14a extends between the top hole and the second inner cavity.

[0078] exist Figure 7B In the example, the flexible member is in the form of an annular flexible member 14d (O-ring). This O-ring is located within a groove / cavity 14m' formed in the distal side of the channel 14a, such that the annular flexible member 14d" abuts / presses against the peripheral sidewall of the groove 14m' and the end effector 14e in a fluid-tight manner.

[0079] exist Figure 7C In the example, the flexible member is in the form of an annular flexible member 14d (O-ring). This O-ring is located within a groove / cavity 14m' formed on the bottom surface 14f of the stimulation unit, such that the annular flexible member 14d” is fluid-tightly abutted / pressed between the sidewall of the groove 14m' and the end effector 14e.

[0080] refer to Figures 8A to 8C The images schematically illustrate different views of specific, non-limiting examples of the configuration of a bone-anchored hearing aid assembly 10. In these examples, the anchoring shaft 12 has a central cavity 12c having an inner circumferential concave surface 12v extending between a top opening 12t and a bottom opening 12b of the anchoring shaft. The assembly 10 has a generally hemispherical angular adjustment unit 20 comprising an axial lumen 12x. The angular adjustment unit 20 is configured to be received and mounted within the central cavity 12c of the anchoring shaft 12 and has an outer circumferential convex surface 20s that matches the inner circumferential concave surface 12v of the anchoring shaft 12. This allows for adjustment of the orientation of the angular adjustment unit 20 relative to the anchoring shaft 12.

[0081] Specifically, the angular displacement unit 20 can be moved within the central cavity 12c between a coaxial position of the unit 20 and an angled / tilted position of the unit 20 (e.g., slidably), in the coaxial position, the main longitudinal axis O1 of the unit 20 coincides with the main longitudinal axis O of the anchoring shaft 12, and in the angled / tilted position, the main longitudinal axis O1 of the unit 20 defines an angle relative to the main longitudinal axis O of the anchoring shaft 12 (the unit 20 is tilted).

[0082] like Figure 8AAs shown, the angular displacement unit 20 has a pass-through bore 20p extending between its upper surface 20u and its convex surface 20s, and the anchoring shaft 12 has an inner bore 12n extending from its concave surface 12v. In the coaxial position of the angular displacement unit 20, the pass-through bore 20p and the inner bore 12n are aligned, and thus can accommodate a locking member 22, such as a pin, bolt, or screw, which locks the angular adjustment unit 20 in its coaxial position when inserted into the two aligned bores.

[0083] For example Figure 8A As illustrated, the angular displacement unit 20 is configured to house a hollow transfer unit 24 within an axial lumen 12x, such that the hollow transfer unit 24 can be detachably attached to the angular displacement unit 20 along the axial lumen 12x. In this non-limiting example, the attachment is threaded, i.e., the transfer unit 24 has threads 24h on its outer surface, which are configured to engage with the internal threads 20h of the angle adjustment unit 20. The transfer unit 24 is configured to allow the insertion of additional elements / devices (such as cochlear implants or endoscopes) into the middle ear.

[0084] Subsequently, the transfer unit 24 can be removed from the axial cavity 12x of the angular displacement unit 20, and the locking member 22 can be inserted into the through hole 20p and the inner hole 12n to lock the angular displacement unit 20 in its coaxial position, as shown. Figure 8B As shown. Then, the stimulation unit 14 can be inserted into the axial lumen 12x.

[0085] like Figure 8B As illustrated, the stimulation unit 14 may include a removable cover 14l' having a through hole 26 configured as a working channel for allowing additional elements to pass through or be coupled with additional elements (e.g., allowing a hypodermal lead to pass through).

[0086] Figure 9 This is a flowchart illustrating an exemplary method 100 for implanting / installing component 10 in an intuitive and easy-to-understand manner. For this purpose, location data regarding a target surface within the skull for implanting the component, and data regarding the exact location, orientation, and size of the borehole for implanting the anchoring axis, are provided. This data is used to generate a 3D model of the skull, the target location and orientation of the borehole, and the distance between the target surface and the skull surface.

[0087] Next, a guiding clamp that can be attached to the skull is used. This guiding clamp can be configured based on a 3D model via 3D printing to guide the drilling tool. In this way, the clamp enables the accurate location, orientation, and depth of the hole, and subsequently the accurate location, orientation, and depth of the anchoring axis and stimulation unit, to accurately position the end effector on the target surface (i.e., the cochlear wall).

[0088] Next, a drilling tool is selected to drill holes for the anchoring shaft and the stimulation unit (end effector). The scalp is then cut and flipped in the drilled area, and if necessary, at the locations for placing the subcutaneous electronic circuitry / modules. A socket is then formed in the skull for placing the subcutaneous electronic circuitry / modules.

[0089] The generated 3D model is used to align and attach the guide jig to the skull. A hole is drilled in the temporal bone using the guide jig and a drilling tool, deep enough to accommodate the anchoring shaft and stimulation unit. Using the same guide tool and another smaller diameter drilling tool, a path through the bone is cut for the end effector and optional microphone wire, deep enough to reach the middle ear cavity. The anchoring shaft tool is used to insert the anchoring shaft into the hole in the temporal bone to the predetermined depth. The anchoring shaft is then locked / anchored to the skull. The stimulation unit and its components are inserted into the anchoring shaft, with the end effector entering first; and an assembly tool is used to screw the stimulation unit into its predetermined depth so that the end effector applies the required force to the cochlear wall. If an acoustic transducer is used, it can be inserted into the middle ear cavity before the stimulation unit is inserted.

[0090] Then, when operating with an external signal source, the device's performance can be tested using auditory brainstem response (ABR), and the force adjusted if necessary. Temporary plugs can be used to seal the wire holes in the stimulation unit. Subcutaneous electronics can be placed / attached to their position. Finally, the flipped-over scalp can be reapplied to the implant.

Claims

1. A bone-anchored hearing aid assembly, comprising: An implantable anchor shaft, the implantable anchor shaft including an axial lumen extending through the implantable anchor shaft and configured to be fixed within a drilled hole drilled into the skull of the subject; A removable stimulation unit is formed to be housed within the axial cavity of the anchoring shaft; The anchoring shaft and the stimulation unit are configured to detachably attach the stimulation unit to the anchoring shaft within the axial lumen of the anchoring shaft; and The removable stimulation unit includes a reciprocating end effector that passes through a bottom hole at the distal end of the removable stimulation unit. The end effector is configured and controllably actuated to perform reciprocating movement along the main longitudinal axis of the removable stimulation unit to mechanically transmit vibrations to the cochlear wall of the subject for perception as sound by the subject.

2. The component according to claim 1, wherein, The removable stimulation unit further includes at least one actuator operatively coupled to the end effector for driving the end effector to perform the reciprocating motion.

3. The component according to claim 2, wherein, The removable stimulation unit includes a first cavity for accommodating the at least one actuator within the first cavity.

4. The component according to claim 3, wherein, The removable stimulation unit includes a channel formed therein, the channel extending between the bottom hole and the inner cavity, such that the end effector performs the reciprocating movement along the channel.

5. The component according to any one of claims 2 to 4, further comprising a cover configured to seal against an opening on the top surface of the removable stimulation unit.

6. The component according to claim 5, wherein, The cover includes a through hole, which serves as a working channel for allowing additional elements to pass through or be attached to additional elements.

7. The component of claim 5, further comprising a cover configured to seal against an opening on the top surface of the removable stimulation unit, wherein, The cover includes a through-hole connected to the internal tubular cavity, the through-hole serving as a common working channel for allowing additional elements to pass through or join additional elements.

8. The component according to any one of claims 6 or 7, wherein, The working channel is configured to allow wires to pass through for connection to one or more microphones located in the inner ear cavity.

9. The component according to any one of claims 5 to 8, wherein, The cover includes one or more recesses configured to receive input from an external tool to insert the removable stimulation unit into the implantable anchoring shaft.

10. The component according to any one of claims 5 to 9, wherein, The removable stimulation unit also includes a spring member arranged such that the spring member extends and is closed between the cover and the at least one actuator.

11. The component of claim 1, further comprising at least one actuator located external to the removable stimulation unit and operatively coupled to the end effector to drive the end effector to perform the reciprocating motion.

12. The component of claim 11, wherein, The removable stimulation unit includes a top hole, through which the end effector passes.

13. The component of claim 12, wherein, The removable stimulus includes a channel extending between the top hole and the bottom hole, such that the end effector performs the reciprocating movement along the channel.

14. The component according to any one of claims 1 to 13, wherein, The stimulation unit includes a flexible member that is fixedly mounted within the stimulation unit and fluid-tightly engaged with a portion of the end effector, thereby holding the end effector on its reciprocating axis while allowing the reciprocating movement of the end effector due to the flexibility of the flexible member.

15. The component of claim 14, wherein, The removable stimulation unit includes a second cavity, and the flexible member is fixedly mounted within the second cavity.

16. The component of claim 15, wherein, The flexible member is fixedly attached to at least one surface defined by the second cavity and fluid-tightly coupled to the circumference of the portion of the end effector, such that the end effector protrudes from the flexible member.

17. The component of claim 16, wherein, The flexible member is configured to be fixedly coupled to a diaphragm on at least one surface defined by the second cavity.

18. The component of claim 17, wherein, The diaphragm has at least one of a dome-shaped structure, a corrugated structure, and a stretchable structure.

19. The component of claim 15, wherein, The flexible member is configured as an O-ring, which is pressed between the end effector and the inner circumferential sidewall of the second cavity.

20. The component according to any one of claims 1 to 19, wherein, The removable stimulation unit and the implantable anchor shaft are configured such that when the removable stimulation unit is housed in the implantable anchor shaft, the distal portion of the removable stimulation unit extends from the bottom surface of the implantable anchor shaft.

21. The component according to any one of claims 1 to 20, wherein, The reciprocating end effector is in the form of a rod, which is coupled to the at least one actuator through its proximal end and is configured to interact with the cochlear wall through its free, relatively distal end, thereby providing the mechanically transmitted vibration to the cochlear wall.

22. The component according to any one of claims 1 to 21, wherein, The outer surface of the removable stimulation unit and the inner surface of the implantable anchor shaft include threads configured for threaded engagement between the outer surface of the removable stimulation unit and the inner surface of the implantable anchor shaft.

23. The component according to any one of claims 1 to 22, wherein, The upper surface of the implantable anchor shaft includes a plurality of spaced recesses configured to receive input from an external tool to insert the implantable anchor shaft into a borehole drilled into the skull of the subject.

24. The component according to any one of claims 1 to 23, wherein, The top surface of the removable stimulation unit includes one or more recesses configured to receive input from an external tool to insert the removable stimulation unit into a selected depth within the implantable anchoring shaft.

25. The component according to any one of claims 1 to 24, wherein, The removable stimulation unit also includes at least one internal hollow channel configured as a working channel for the attachment element to pass through or combine with the attachment element.

26. The component according to any one of claims 1 to 25, wherein, The anchoring shaft includes a central cavity and is configured to house an angular displacement unit within the cavity, the angular displacement unit being configured to perform angular displacement relative to the implantable anchoring shaft.

27. The component of claim 26, wherein, The axial cavity is formed in the angular displacement unit, and the central cavity has an inner circumferential concave surface. When the angular displacement unit is housed in the implantable anchoring shaft, the inner circumferential concave surface faces the substantially matching outer circumferential convex surface of the angular displacement unit, thereby enabling the adjustable orientation of the angular displacement unit relative to the anchoring shaft.

28. The component according to claim 26 or 27, wherein, The implantable anchor and / or the implantable anchor shaft includes a fixing mechanism configured to fix the angular displacement unit at a coaxial position relative to the implantable anchor shaft, wherein the main longitudinal axis of the implantable anchor shaft coincides with the main longitudinal axis of the angular displacement unit.

29. The component of claim 28, wherein, The angular displacement unit includes a through hole extending between its upper surface and its convex surface, and the implantable anchor shaft includes a corresponding hole extending from its concave surface, the holes being aligned in the coaxial position and configured to accommodate a locking member within the holes, thereby locking the angular displacement unit and the implantable anchor shaft in the coaxial position.

30. The component according to any one of claims 27 to 29, wherein, The angular displacement unit is configured to accommodate a hollow delivery unit within the axial lumen of the angular displacement unit; wherein the anchoring shaft and the angular displacement unit are configured to detachably attach the stimulation unit to the anchoring shaft within the axial lumen of the anchoring shaft; and wherein the delivery unit is configured to allow the insertion of additional elements / devices into the middle ear cavity.

31. The component according to any one of claims 1 to 30, wherein, The implantable anchoring shaft is made of one or more biocompatible material components.

32. The component of claim 31, wherein, The implantable anchoring shaft is made of one or more MRI-compatible material components.

33. The component according to any one of claims 2 to 32, wherein, The at least one actuator includes a piezoelectric actuator.

34. The component according to any one of claims 2 to 32, wherein, The at least one actuator includes an electromagnetic transducer.

35. A removable stimulating unit for use in a component according to any one of the preceding claims.

36. A removable stimulation unit for use in a bone-anchored hearing aid assembly, the removable stimulation unit being configured to be detachably attached within an axial lumen of an implantable anchor shaft when the implantable anchor shaft is installed within a borehole drilled into the skull of a subject, wherein, The removable stimulation unit has a bottom hole at its distal end and includes at least one actuator and a reciprocating end effector passing through the bottom hole. The end effector is configured to perform reciprocating movement along the main longitudinal axis of the removable stimulation unit to mechanically transmit vibrations to the cochlear wall of the subject for perception as sound by the subject, and the at least one actuator is operatively coupled to the end effector to drive the end effector to perform the reciprocating movement.

37. A kit for assembling an implantable hearing aid for mechanically transmitting vibrations to the cochlea of ​​a subject, the kit comprising: A number of N (N≥1) removable stimulation units, each removable stimulation unit being configured according to claim 34 for detachably attaching to a predetermined anchoring shaft implanted in a borehole in the skull of the subject; and One or more tools for inserting the removable stimulation unit into a selected depth within the implantable anchoring shaft.

38. The kit of claim 37 further comprises one or more elements located within at least one working channel formed in the removable stimulation unit.

39. The kit of claim 37 or 38 further includes at least one microphone, said at least one microphone being mounted near the cochlea via said removable stimulation unit.

40. A kit for assembling an implantable hearing aid for mechanically transmitting vibrations to the cochlea of ​​a subject, the kit comprising: There are N (N≥1) anchoring shafts, each configured to be implanted into a hole in the subject's skull. A number of M (M≥1) removable stimulation units, each removable stimulation unit being configured according to claim 35 to be removably attached to the anchoring shaft when the selected anchoring shaft is implanted into the borehole in the skull; Tools for inserting the implantable anchoring shaft into one or more holes drilled into the skull of the subject; and One or more tools for inserting the removable stimulation unit into a selected depth within the implantable anchoring shaft.

41. The kit of claim 40 further comprises one or more elements located within at least one working channel formed in the removable stimulation unit.

42. The kit according to claim 40 or 41 further includes at least one microphone, said at least one microphone being mounted near the cochlea via said removable stimulation unit.

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