EP3148216A1

EP3148216A1 - A stent member for being inserted in an ear canal

Info

Publication number: EP3148216A1
Application number: EP15186236.4A
Authority: EP
Inventors: Karsten Bo Rasmussen; Jacob Holdt Hansen; Troels Holm Pedersen; Thor Højlund Olsen; Martin Lindebjerg; Bent Severin
Original assignee: Oticon AS
Current assignee: Oticon AS
Priority date: 2015-09-22
Filing date: 2015-09-22
Publication date: 2017-03-29

Abstract

A stent member (2) for insertion in the ear canal (22) of a hearing device user, wherein the stent member is expandable and defines an inner space configured to receive a hearing device (12). The stent member is adapted to be inserted into the ear canal in a compressed state and adapted to be radially expanded when arranged in the ear canal.

Description

FIELD

The present disclosure relates to a stent member configured to be permanently and tightly inserted in the ear canal. More particularly, the disclosure relates to a stent member that is both configured to be permanently and tightly inserted in the ear canal and to receive a hearing device so that the hearing device can be positioned in the most appropriate position in the ear canal.

BACKGROUND

Invisible instant hearing instruments need to be inserted deep in the ear canal. The correct positioning of the device in the canal is very important in order to ensure low occlusion, good sound quality and the correct acoustic output level. Furthermore, the risk of inserting the device too deep in the canal must be eliminated in order to avoid the danger of damage of the eardrum.
A prior art solution is to let a hearing care professional handle the insertion, which is semi-permanent (up to several months). This solution necessitates changing the entire hearing instrument every few months, when the battery needs changing.
It has previously been proposed to permanently insert a foam dome in the ear canal. This approach may, however, cause problems due to the very long exposure of the skin to the plastic material in the foam dome.
Therefore, there is a need to provide an alternative to this prior art solution.

SUMMARY

According to an aspect of the disclosure, the stent member is a stent member for insertion in the ear canal of a hearing device user, wherein the stent member is expandable and defines an inner space configured to receive a hearing device, wherein the stent member is adapted to be inserted into the ear canal in a compressed state and adapted to be radially expanded when arranged in the ear canal.
Hereby, it is possible to provide a stent member configured to be permanently and tightly inserted in the ear canal so that the hearing device can be sealingly arranged in the bony region of the ear canal.
The method makes it possible to insert a stent member that function as a "docking station" configured to receive a hearing device. Hereafter it is possible to remove the hearing device from or insert it again into the stent member when the hearing device is needed. Accordingly, the hearing device can be removed when the user is swimming or at night or when or if the battery needs to be replaced.
The stent member may have a tube-like structure with wall portions that are configured to be radially expanded.
The stent member is expandable and defines an inner space configured to receive a hearing device. Since the stent member is adapted to be inserted into the ear canal in a compressed state and adapted to be radially expanded when arranged in the ear canal, the stent member can be used to sealingly arrange the hearing device in the bony region of the ear canal.
In an embodiment, the stent member is configured to be radially compressed before insertion into the ear canal and hereafter be expanded when the correct position in the inner bony part of the ear canal is achieved.
In an embodiment, the stent member comprises a plurality of wire members constituting a mesh structure.
Hereby, it is possible to achieve a strong and robust stent member capable of being radially compressed and expanded and further capable of providing a basis for insertion of the hearing device. The wire members may be made in any suitable material including metal. The wire members may be made of fibers comprising polymers, plastics (e.g. polyethelene), metals and composites.
In an embodiment, the stent member comprises a plurality of connected expandable ring structures capable of being expanded and preferably capable of being radially compressed.
In an embodiment, the stent member comprises a plurality of connected expandable pin structures of board-like structures capable of being radially expanded and compressed.
In an embodiment of the disclosure, the stent member comprises two, three or four protrusions.
Hereby, the protrusions can prevent the hearing device from being moved further along the axial direction of the stent member, when the hearing device abuts the protrusions. Therefore, the protrusions restrict axial displacement of the hearing device.
In an embodiment, the protrusions extend basically perpendicular to the longitudinal axis of the stent member.
Hereby, the protrusions are particularly capable of preventing the hearing device from being moved further along the axial direction of the stent member, when the hearing device abuts the protrusions.
In an embodiment, the protrusions are evenly distributed along the inner periphery of the stent member.
Hereby, the stress of the stent member can be minimised, since a symmetric load is exerted by the hearing device towards the protrusions when the hearing device abuts the protrusions.
In an embodiment, the protrusions are arranged at the distal portion of the stent member.
Hereby, the size of the stent can be minimised and the hearing device can extend along the full or majority of the length of the stent member.
In an embodiment, the protrusions are arranged at the distal portion of the stent member, at the rim of the stent member.
Hereby, the size of the stent can be minimised and the hearing device can extend along the full length of the stent member.
In an embodiment, the protrusions are made of a relatively soft and/or flexible material (e.g. silicone or a foam, e.g. a polymeric foam (e.g. microcellular plastic foam; i.e. comprising micropores)) to allow the hearing device to be inserted in the stent with a relatively tight fitting.
According to yet another aspect of the disclosure, the system is a system comprising a stent member according to the disclosure and a positioning member for inserting the stent member into the ear canal, wherein the positioning member is configured to be inserted into the inner space of the stent member in a manner in which the positioning member extends at least partially through the inner space of the stent member, wherein the positioning member and/or the stent member comprises an expansion device for expanding the stent member radially.
Hereby, the system can be used to insert the stent member into the correct position in the bony region of the ear canal.
According to a further aspect of the disclosure, the expansion device comprises an inflatable member extending at least partially through the inner space of the stent member.
Hereby, the inflatable member is capable of expanding the stent member in order to provide a tight arrangement of the stent member in the ear canal, preferably in the bony region of the ear canal.
According to another aspect of the disclosure, the inflatable member comprises an inflatable balloon.
By using an inflatable balloon, it is possible to expand the stent member with an evenly distributed force along the inner structure of the stent member in a simple manner. Moreover, a balloon can easily be detached from the stent member, by deflating the balloon.
According to a further aspect of the disclosure, the expansion device comprises a hollow rod member or tube member.
By means of hollow rod member or tube member, it is possible to inflate the balloon and to deflate the balloon through the hollow portion of the rod member or tube member.
According to a further aspect of the disclosure, the expansion device comprises an insertion member and a plurality of attachment members extending between the stent member and the insertion member.
Hereby, it is possible to insert the stent member into the ear canal in a compressed configuration. The plurality of attachment members extending between the stent member and the insertion member may be configured to maintain the stent member in a compressed configuration.
It may be an advantage that the insertion member may be elongated.
According to an even further aspect of the disclosure, the expansion device comprises a detachment member configured to detach the attachment members from the insertion member.
Hereby, the detachment member can be used to detach the attachment members from the insertion member in order to allow the insertion member to be removed and the stent member to be radially expanded when arranged in the correct position in the ear canal.
According to yet another aspect of the disclosure, the detachment member comprises a plurality of openings or apertures.
Hereby, the plurality of attachment members can extend between the stent member and the insertion member.
According to a further aspect of the disclosure, a wire extends through the opening or aperture in at least a part of the openings or apertures.
Hereby, the wires can be used as attachment members detachably attached to the insertion member and the stent member.
According to yet another aspect of the disclosure, the detachment member is slidably attached to the insertion member.
Hereby it is possible to detach the attachment members from the stent member by displacing the detachment member relative to the insertion member.
According to a further aspect of the disclosure, the inflatable member or the insertion member comprises a rod member attached to the proximal end of the inflatable member or the insertion member.
Hereby, insertion of the stent member is eased. It may be an advantage that the rod member is sufficiently rigid to resist bending during insertion of the stent member into the ear canal.
The method according to the disclosure is a method for arranging a stent member into the ear canal of a hearing device user, which method comprises the steps of:

inserting a stent member having an inner space into the ear canal of a hearing device user, wherein the stent member is in a compressed state;
expanding the stent member radially by means of an expansion device at last partly extending through the inner space of the stent member;
removing the expansion device from the inner space of the stent member.

The method makes it possible to insert a stent member that function as a "docking station" configured to receive a hearing device. The hearing device may hereafter be removed and reinserted into the stent member when the hearing is needed. It may be advantageous to be able to remove the hearing device when the user is swimming or at night or when the battery needs to be replaced.
According to a further aspect of the disclosure, the method applies an expansion device shaped as an inflatable member that is configured to be inflated through a hollow rod member or a tube.
Hereby, it is possible to inflate the balloon and to deflate the balloon through the hollow portion of the rod member or tube member.
According to yet another aspect of the disclosure, the method applies an expansion device formed as an insertion member comprising a plurality of attachment members extending between the wire member(s) and the insertion member, wherein the method comprises the step of detaching the stent member from the insertion member by cutting the attachment members.
Hereby, it is possible to keep the stent member in a compressed configuration by means of the attachment members and to detach the stent member from the insertion member by cutting the attachment members.

BRIEF DESCRIPTION OF DRAWINGS

The aspects of the disclosure may be best understood from the following detailed description taken in conjunction with the accompanying figures. The figures are schematic and simplified for clarity, and they just show details to improve the understanding of the claims, while other details are left out. Throughout, the same reference numerals are used for identical or corresponding parts. The individual features of each aspect may each be combined with any or all features of the other aspects. These and other aspects, features and/or technical effects will be apparent from and elucidated with reference to the illustrations described hereinafter in which:

Fig. 1A: shows a schematic view of a stent member according to an embodiment of the disclosure being inserted into an ear canal of a user;
Fig. 1B: shows a schematic view of the stent member shown in Fig. 1A attached in the bony region of the ear canal;
Fig. 2A: shows a schematic view of a stent member according to an embodiment of the disclosure being inserted into an ear canal of a user by means of an insertion member;
Fig. 2B: shows a schematic view of the stent member shown in Fig. 2A attached in the bony region of the ear canal;
Fig. 3A: shows a cross-sectional view of a stent member according to an embodiment of the disclosure in a compressed configuration;
Fig. 3B: shows a cross-sectional view of the stent member shown in Fig. 3A in an expanded configuration;
Fig. 3C: shows a close-up view of how the detachment member detaches the stent member from the insertion member;
Fig. 4A: shows a cross-sectional view of a stent member arranged on an insertion member according to the disclosure in a compressed configuration;
Fig. 4B: shows a perspective exploded view of the stent member shown in Fig. 4A in an expanded configuration;
Fig. 5A: shows a schematic side view of a stent member according to an embodiment of the disclosure;
Fig. 5B: shows a schematic end view of the stent member shown in Fig. 5A;
Fig. 6A: shows a schematic view of a stent member according to an embodiment of the disclosure positioned in the ear canal with a hearing device attached to the stent member;
Fig. 6B: shows a close-up view of the stent member shown in Fig. 6A;
Fig. 7A: shows a schematic side view of a stent member according to a first embodiment of the disclosure;
Fig. 7B: shows a schematic end view of the stent member shown in Fig. 7A;
Fig. 7C: shows a schematic side view of a stent member according to a second embodiment of the disclosure;
Fig. 7D: shows a schematic end view of the stent member shown in Fig. 7C;
Fig. 7E: shows a schematic side view of a stent member according to a third embodiment of the disclosure and
Fig. 7F: shows a schematic end view of the stent member shown in Fig. 7E.

DETAILED DESCRIPTION

The detailed description set forth below in connection with the appended drawings is intended as a description of various configurations. The detailed description includes specific details for the purpose of providing a thorough understanding of various concepts. However, it will be apparent to those skilled in the art that these concepts may be practiced without these specific details. Several aspects of the apparatus and methods are described by various blocks, functional units, modules, components, circuits, steps, processes, algorithms, etc. (collectively referred to as "elements"). Depending upon particular application, design constraints or other reasons, these elements may be implemented using electronic hardware, computer programs, or any combination thereof.
The printed circuit board may comprise any suitable electronic hardware, including microprocessors, microcontrollers, digital signal processors (DSPs), field programmable gate arrays (FPGAs), programmable logic devices (PLDs), gated logic, discrete hardware circuits, and other suitable hardware configured to perform the various functionality described throughout this disclosure. Computer program shall be construed broadly to mean instructions, instruction sets, code, code segments, program code, programs, subprograms, software modules, applications, software applications, software packages, routines, subroutines, objects, executables, threads of execution, procedures, functions, etc., whether referred to as software, firmware, middleware, microcode, hardware description language, or otherwise.
A hearing device may include a hearing aid that is adapted to improve or augment the hearing capability of a user by receiving an acoustic signal from a user's surroundings, generating a corresponding audio signal, possibly modifying the audio signal and providing the possibly modified audio signal as an audible signal to at least one of the user's ears. The "hearing device" may further refer to a device such as an earphone or a headset adapted to receive an audio signal electronically, possibly modifying the audio signal and providing the possibly modified audio signal as an audible signal to at least one of the user's ears. Such audible signals may be provided in the form of an acoustic signal radiated into the user's outer ear, or an acoustic signal transferred as mechanical vibrations to the user's inner ear through bone structure of the user's head and/or through parts of the middle ear of the user or electric signals transferred directly or indirectly to the cochlear nerve and/or to the auditory cortex of the user.
The hearing device is adapted to be worn in any known way. This may include i) arranging a unit of the hearing device behind the ear with a tube leading air-borne acoustic signals into the ear canal or with a receiver/ loudspeaker arranged close to or in the ear canal such as in a Behind-the-Ear type hearing aid, and/ or ii) arranging the hearing device entirely or partly in the pinna and/ or in the ear canal of the user such as in a In-the-Ear type hearing aid or In-the-Canal/ Completely-in-Canal type hearing aid, or iii) arranging a unit of the hearing device attached to a fixture implanted into the skull bone such as in a Bone Anchored Hearing Aid or Cochlear Implant, or iv) arranging a unit of the hearing device as an entirely or partly implanted unit such as in a Bone Anchored Hearing Aid or a Cochlear Implant.
A "hearing system" refers to a system comprising one or two hearing devices, and a "binaural hearing system" refers to a system comprising two hearing devices where the devices are adapted to cooperatively provide audible signals to both of the user's ears. The hearing system or binaural hearing system may further include an auxiliary device(s) that communicates with at least one hearing device, the auxiliary device affecting the operation of the hearing devices and/or benefitting from the functioning of the hearing devices. A wired or wireless communication link between the at least one hearing device and the auxiliary device is established that allows for exchanging information (e.g. control and status signals, possibly audio signals) between the at least one hearing device and the auxiliary device. Such auxiliary devices may include at least one of the following: remote controls, remote microphones, audio gateway devices, mobile phones, public-address systems, car audio systems or music players or a combination thereof. The audio gateway is adapted to receive a multitude of audio signals such as from an entertainment device like a TV or a music player, a telephone apparatus like a mobile telephone or a computer, or a PC. The audio gateway is further adapted to select and/or combine an appropriate one of the received audio signals (or combination of signals) for transmission to the at least one hearing device. The remote control is adapted to control functionality and operation of the at least one hearing devices. The function of the remote control may be implemented in a SmartPhone or in another electronic device, the SmartPhone/ electronic device possibly running an application that controls functionality of the at least one hearing device.
In general, a hearing device includes i) an input unit such as a microphone for receiving an acoustic signal from a user's surroundings and providing a corresponding input audio signal, and/or ii) a receiving unit for electronically receiving an input audio signal. The hearing device further includes a signal processing unit for processing the input audio signal and an output unit for providing an audible signal to the user in dependence on the processed audio signal.
The input unit may include multiple input microphones, e.g. for providing direction-dependent audio signal processing. Such a directional microphone system is adapted to enhance a target acoustic source among a multitude of acoustic sources in the user's environment. In one aspect, the directional system is adapted to detect (such as adaptively detect) from which direction a particular part of the microphone signal originates. This may be achieved by using conventionally known methods. The signal processing unit may include an amplifier that is adapted to apply a frequency dependent gain to the input audio signal. The signal processing unit may further be adapted to provide other relevant functionality such as compression, noise reduction, etc. The output unit may include an output transducer such as a loudspeaker/ receiver for providing an air-borne acoustic signal transcutaneously or percutaneously to the skull bone or a vibrator for providing a structure-borne or liquid-borne acoustic signal. In some hearing devices, the output unit may include one or more output electrodes for providing the electric signals such as in a Cochlear Implant.
Now referring to Fig. 1A which illustrates a schematic view of a stent member 2 according to an embodiment of the disclosure being inserted into an ear canal 22 of a user. The stent member 2 comprises a first portion of wire members 8 extending parallel to each other and a second portion of wire members 10 extending parallel to each other. The first portion of wire members 8 basically extend perpendicular to the second portion of wire members 10. The stent member 2 comprises a plurality of meshes 20.
The stent member 2 is being inserted into the ear canal 22 in a manner in which the stent member 2 tightly fits the ear canal 22 and thus abuts the ear canal tissue 24. The stent member 2 is arranged on an inflatable member 26 that is mechanically connected to a hollow rod member 28. Hereby, the inflatable member 26 can be inflated and deflated through the canal in the hollow rod member 28.
The inflatable member 26 can be removed from the stent member 2 when the inflatable member 26 has been deflated in order to reduce the volume of the inflatable member 26.
Fig. 1B illustrates a schematic view of the stent member 2 shown in Fig. 1A attached in the bony region of the ear canal 22 of a hearing device user. It can be seen that the inflatable member (shown in Fig. 1A) has been removed. The removal of the inflatable member can be accomplished by deflating the inflatable member and displacing the inflatable member along the longitudinal axis X of the stent member 2.
Fig. 1B shows that the stent member 2 comprises an inner space 30 configured to receive a hearing device. The stent member 2 may preferably be permanently attached to the bony region of the ear canal 22.
Compared with Fig. 1A, Fig. 1B shows that the stent member 2 has been slightly compressed when the inflatable member has been removed. This can be seen when comparing the size of the meshes 20 in Fig. 1A and Fig. 1B, respectively.
Fig. 2A shows a schematic view of a stent member 2 according to an embodiment of the disclosure being inserted into an ear canal 22 of a user by means of an insertion member 32.
The stent member 2 comprises a first portion of wire members 8 extending parallel to each other and a second portion of wire members 10 extending parallel to each other. The first portion of wire members 8 and the second portion of wire members 10 extend basically perpendicular to each other and constitute a plurality of meshes 20.
The stent member 2 has been inserted into the ear canal 22 in such a way that the stent member 2 tightly fits the ear canal 22 and abuts the ear canal tissue 24. The stent member 2 comprises an inner space 30. An insertion member 32 is being removed from the inner space 30 by pulling a rod member 34 attached to the proximal end of the insertion member 32.
Fig. 2B illustrates a schematic view of the stent member 22 shown in Fig. 2A attached in the bony region of the ear canal 22. The stent member 2 has been permanently attached to the bony region of the ear canal 22. The insertion member (shown in Fig. 2A) has been removed (displaced along the longitudinal axis X of the stent member 2).
Fig. 3A illustrates a cross-sectional view of a stent member 2 according to an embodiment of the disclosure in a compressed configuration, in which the diameter d₁ of the stent member 2 is indicated. The stent member 2 comprises a first wire member 8 and a second wire member 10. An insertion member 32 is arranged in the inner space 30 defined by the stent member 2.
The insertion member 32 is formed as an elongated body having a cylindrical geometry. A detachment member 36 is arranged at the outer periphery of the insertion member 32. A plurality of apertures 40 are provided in the detachment member 36. A plurality of cutting members 38 are provided adjacent to each aperture 40. A plurality of attachment members 42 extend between the insertion member 32 and the wire member 8 of the stent member 2. The attachment members 42 extend through the apertures 40 and since the detachment member 36 is slidably attached to the insertion member 32 thus the attachment members 42 can be cut by displacing the detachment member 36 relative to the insertion member 32 (like illustrated in Fig. 3B).
Fig. 3B illustrates a cross-sectional view of the stent member 2 shown in Fig. 3A in an expanded configuration, in which the diameter d₂ is larger than the diameter d₁ of the stent member 2 in the compressed configuration shown in Fig. 3A.
It can be seen that the stent member 2 is "released" by cutting the attachment members 42 shaped as small wire members that extended between the insertion member 32 and the stent member 2 before they were cut by the cutting members 38 of the detachment member 36 that is slidably attached to the insertion member 32.
Fig. 3C illustrates a close-up view showing how the detachment member 36 detaches the stent member 2 from the insertion member 32. It is indicated that the detachment member 36 has been displaced the distance L compared with the configuration shown in Fig. 3A. Accordingly, the detachment member 36 has cut the attachment members 42 extending through the apertures 40 between the insertion member 32 and the stent member 2 (like illustrated in Fig. 3A).
Fig. 4A illustrates a cross-sectional view of a stent member 2 arranged on an insertion member 32 according to the disclosure in a compressed configuration. The stent member corresponds to the one illustrated in Fig. 3A. The stent member 2 is basically shaped as a flower and thus has a smaller diameter d₁ than the diameter d₂ in the expanded configuration shown in Fig. 4B.
Fig. 4B illustrates a perspective exploded view of the stent member 2 shown in Fig. 4A (and in Fig. 3B) in an expanded configuration in which the diameter d₂ is larger than the diameter d₁ of the stent member 2 shown in Fig. 4A.
In Fig. 4A and in Fig. 4B, it can be seen that a massive insertion member 32 is surrounded by a detachment member 36. In Fig. 4A, the stent member is attached to the insertion member 32 by means of attachment members shaped as wires (see Fig. 3A for a better view). In Fig. 4B, however, the attachment members have been cut and the stent member 2 has expanded radially.
Fig. 5A illustrates a schematic side view of a stent member 2 according to an embodiment of the disclosure. The stent member 2 is basically cylindrical and comprises a first portion of wire members 8 extending parallel to each other and a second portion of wire members 10 extending parallel to each other. The cylindrical body of the stent member 2 has a longitudinal axis X.
The first portion of wire members 8 and the second portion of wire members 10 extend basically perpendicular to each other and constituting a plurality of meshes 20. The stent member 2 comprises a plurality of protruding structures 4, 4', 6 arranged along the inner rim of the stent member 2. The protruding structures 4, 4', 6 are configured to prevent a hearing device from being displaced further along the longitudinal axis X of the stent member 2 when being "docked" into the stent member 2.
Fig. 5B illustrates a schematic end view of the stent member 2 shown in Fig. 5A. It can be seen that the stent members 4, 4', 6, 6' are evenly distributed along the inner rim of the stent member 2 and that the stent members 4, 4', 6, 6' extend perpendicular to the longitudinal axis X of the stent member 2.
Fig. 6A illustrates a schematic view of a stent member 2 according to an embodiment of the disclosure positioned in the ear canal with a hearing device 12 attached to the stent member 2. The stent member 2 has been permanently arranged in the bony region in the ear canal in the optimum distance from the ear drum 18.
Fig. 6B illustrates a close-up view of the stent member 2 shown in Fig. 6A. It can be seen that the stent member 2 is arranged in the bony region 16 of the ear canal 22. Hereby the hearing device 12 can easily be arranged in the ear canal 22 in the most optimum distance from the ear drum 18. It can be seen that the hearing device 12 comprises a front portion 14 adapted to be received and maintained fixed in the stent member 2.
Fig. 7A illustrates a schematic side view of a stent member 2 according to a first embodiment of the disclosure, whereas Fig. 7B illustrates a schematic end view of the stent member 2 shown in Fig. 7A. The stent member 2 comprises a plurality of wires 8, 10 constituting a cylindrical body having an inner space configured to receive and maintain a hearing device in a fixed position. The stent member 2 comprises three protruding structures 4, 4', 6 evenly distributed along the inner rim of the stent member 2. The protruding structures 4, 4', 6 have a basically rectangular shape and extend basically perpendicular to the longitudinal axis of the stent member 2.
Fig. 7C illustrates a schematic side view of a stent member 2 according to a second embodiment of the disclosure, and Fig. 7D illustrates a schematic end view of the stent member 2 shown in Fig. 7C. The stent member 2 basically corresponds to the one shown in Fig. 7A and in Fig. 7B. The stent member 2 comprises a plurality of wires 8, 10 forming a cylindrical body having an inner space configured to receive and maintain a hearing device in a fixed position. The stent member 2 is provided with four protruding structures 4, 4', 6, 6' evenly distributed along the inner rim of the stent member 2. The protruding structures 4, 4', 6 have a basically semi-circular shape and extend basically perpendicular to the longitudinal axis of the stent member 2.
Fig. 7E illustrates a schematic side view of a stent member 2 according to a third embodiment of the disclosure, and Fig. 7F illustrates a schematic end view of the stent member shown in Fig. 7E. The stent member 2 basically corresponds to the one shown in Fig. 7C and in Fig. 7D. The stent member 2 is equipped with a plurality of wires 8, 10 that constitute a cylindrical body provided with an inner space adapted to receive and maintain a hearing device in a fixed position. The stent member 2 is provided with four protruding structures 4, 4', 6 evenly distributed along the inner rim of the stent member 2. The protruding structures 4, 4', 6 extend basically perpendicular to the longitudinal axis of the stent member 2.
As used, the singular forms "a," "an," and "the" are intended to include the plural forms as well (i.e. to have the meaning "at least one"), unless expressly stated otherwise. It will be further understood that the terms "includes," "comprises," "including," and/or "comprising," when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. It will also be understood that when an element is referred to as being "connected" or "coupled" to another element, it can be directly connected or coupled to the other element, but an intervening element may also be present, unless expressly stated otherwise. Furthermore, "connected" or "coupled" as used herein may include wirelessly connected or coupled. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items. The steps of any disclosed method is not limited to the exact order stated herein, unless expressly stated otherwise.
It should be appreciated that reference throughout this specification to "one embodiment" or "an embodiment" or "an aspect" or features included as "may" means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. Furthermore, the particular features, structures or characteristics may be combined as suitable in one or more embodiments of the disclosure. The previous description is provided to enable any person skilled in the art to practice the various aspects described herein. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects.
The claims are not intended to be limited to the aspects shown herein, but are to be accorded the full scope consistent with the language of the claims, wherein reference to an element in the singular is not intended to mean "one and only one" unless specifically so stated, but rather "one or more." Unless specifically stated otherwise, the term "some" refers to one or more.
Accordingly, the scope should be judged in terms of the claims that follow.

List of reference numerals

2: Stent member
4, 4': Protruding structure
6, 6': Protruding structure
8, 10: Wire member
12: Hearing device
14: Front portion
16: Bony region
20: Mesh
22: Ear canal
24: Ear canal tissue
26: Inflatable member
28: Rod member
30: Inner space
32: Insertion member
34: Rod member
36: Detachment member
38: Cutting member
40: Aperture
42: Attachment member
X: Longitudinal axis
d₁, d₂: Diameter
L: Distance

Claims

A stent member (2) for insertion in the ear canal (22) of a hearing device user, wherein the stent member (2) is expandable and defines an inner space (30) configured to receive a hearing device (12), wherein the stent member (2) is adapted to be inserted into the ear canal (22) in a compressed state and adapted to be radially expanded when arranged in the ear canal (22).
A stent member (2) according to claim 1 comprising a plurality of wire members (8, 10) constituting a mesh structure (8, 10).
A stent member (2) according to claim 1 or claim 2, wherein the stent member (2) comprises one or more protrusions (4, 4', 6, 6') configured to prevent the hearing device (12) from being displaced further along the longitudinal axis (X) of the stent member (2).
A stent member (2) according to claim 3, wherein the protrusions (4, 4', 6, 6') extend basically perpendicular to the longitudinal axis (X) of the stent member (2).
A system comprising a stent member (2) according to one of the preceding claims and a positioning member (26, 28, 32, 34) for inserting the stent member (2) into the ear canal (22), wherein the positioning member (26, 28, 32, 34) is configured to be inserted into the inner space (30) of the stent member (2) in a manner in which the positioning member (26, 28, 32, 34) extends at least partially through the inner space (30) of the stent member (2), wherein the positioning member (26, 28, 32, 34) and/or the stent member (2) comprises an expansion device (26, 28, 32, 34, 36, 38, 40, 42) for expanding the stent member (2) radially.
A system according to claim 5, wherein the expansion device (26, 28, 32, 34, 36, 38, 40, 42) comprises an inflatable member (26) extending at least partially through the inner space (30) of the stent member (2).
A system according to claim 6, wherein the inflatable member (26) comprises an inflatable balloon (26).
A system according to claim 7, wherein the expansion device (26, 28, 32, 34, 36, 38, 40, 42) comprises a hollow rod member or tube member (28).
A system according to claim 6, wherein the expansion device (26, 28, 32, 34, 36, 38, 40, 42) comprises an insertion member (32) and a plurality of attachment members (42) extending between the stent member (2) and the insertion member (32).
A system according to claim 7, wherein the expansion device (26, 28, 32, 34, 36, 38, 40, 42) comprises a detachment member (36) configured to detach the attachment members (42) from the insertion member (32).
A system according to claim 9 or claim 10, wherein the detachment member (36) comprises a plurality of openings or apertures (40)
A system according to claim 11, wherein a wire (42) extends through the opening or aperture (40) in at least a part of the openings or apertures (40).
A system according to one of the claims 10-12, wherein the detachment member (36) is slidably attached to the insertion member (32).
A system according to one of the claims 6-13, wherein the inflatable member (26) or the insertion member (32) comprises a rod member (28, 34) attached to the proximal end of the inflatable member (26) or the insertion member (32).
Method for arranging a stent member into the ear canal (22) of a hearing device user, which method comprises the steps of:
- inserting a stent member (2) having an inner space (30) into the ear canal (22) of a hearing device user, wherein the stent member (2) is in a compressed state;

- expanding the stent member (2) radially by means of an expansion device (26) at last partly extending through the inner space (30) of the stent member (2);

- removing the expansion device (26) from the inner space (30) of the stent member (2).
Method according to claim 15, wherein the expansion device (26) is an inflatable member (26) that is configured to be inflated through a hollow rod member (28) or a tube.