EP1215937B1 - Fixation element for implantable microphone - Google Patents

Description

The present invention relates to a fixation element for an implantable microphone which can be inserted into a bore that extends through the auditory canal wall.

Such a fixation element is for example from the DE 197 52 447 A1 known. In this case, the fixation element comprises a cylindrical portion which surrounds a part of the microphone provided with a sound receiving element on its outer circumference and thereby leaves free the sound input membrane of the microphone. The cylindrical portion is provided on the side facing the ear canal in the implanted state with projecting elastic flange parts which rest in the implanted state on the relevant side of the auditory canal wall. On the side remote from the auditory canal, the cylindrical section is provided with a further flange part, which in the implanted state bears against the other side of the auditory canal wall. The flange portions and the cylindrical portion form a collar by which the microphone is secured in the ear canal wall. The cylindrical portion is smooth on its outside to abut the bore wall.

From the WO 97/36457 For example, there is known a fixation member for securing a microactuator of an implantable hearing system in a bore in the promontory, wherein a sleeve-like member is inserted into the bore provided at one end with a circumferential projecting flange which abuts one side of the promontory. Within the bore, the sleeve-like part is formed as a hollow cylinder with a smooth outer surface. At the opposite end of the flanged end of the hollow cylindrical portion is provided with a region in which the inner and outer diameter of the hollow cylinder increases in a funnel-like manner. The cylindrically shaped microactuator is inserted from the flange side of the sleeve-like part in this and locked by means of a locking device formed on the flange.

It is an object of the present invention to provide a functionally improved fixation element for an implantable microphone.

This object is achieved by fixation elements, as defined in claims 1 and 26.

In the solution according to claim 1 is advantageous that a fixation of the fixation element in at least one axial direction of the bore is achieved by a simple design measure and, if necessary. A good seal of the bore in the ear canal wall is achieved without a flange projecting into the ear canal would be required, whereby the fixation element can be particularly easily inserted into the bore.

In the solution according to claim 26 is advantageous that it is not necessary to move the voltage applied in the implanted state on the side of the ear canal wall flange through the bore therethrough. Rather, the part carrying this flange can be placed in the manner of a cap on the microphone-carrying part to fix the microphone in the ear canal wall.

Preferred embodiments of the invention will become apparent from the dependent claims.

• Fig. 1a und 1b eine Schnittansicht eines erfindungsgemäßen Fixationselements vor bzw. nach dem Eindringen in eine Bohrung in der Gehörgangswand gemäß einer ersten Ausführungsform;
• Fig. 2 eine Ansicht wie Fig. 1a, wobei jedoch das Fixationselement in einer Seitenansicht dargestellt ist;
• Fig. 3a eine perspektivische Ansicht eines nicht unter die Erfindung fallenden Fixationselements, das in Fig. 3b und 3c im Querschnitt vor bzw. nach dem Einführen in eine Gehörgangswandbohrung dargestellt ist;
• Fig. 4a und 4b eine Seitenansicht, teilweise im Schnitt dargestellt, eines erfindungsgemäßen Fixationselements beim bzw. nach dem Einführen in eine Gehörgangswandbohrung gemäß einer zweiten Ausführungsform;
• Fig. 5a und 5b eine Ansicht gemäß Fig. 4a bzw. 4b, wobei jedoch eine dritte Ausführungsform dargestellt ist;
• Fig. 6a und 6b eine Ansicht wie Fig. 5a bzw. 5b, wobei jedoch eine vierte Ausführungsform der Erfindung dargestellt ist;
• Fig. 7a und 7b eine Ansicht wie Fig. 5a bzw. 5b, wobei jedoch eine fünfte Ausführungsform der Erfindung dargestellt ist;
• Fig. 8 eine Ansicht wie Fig. 3a, wobei jedoch alternatives, ebenfalls nicht unter die Erfindung fallendes Fixationselement dargestellt ist;
• Fig. 9a, 9b und 9c eine Seitenansicht, teilweise im Schnitt dargestellt, eines erfindungsgemäßen Fixationselements gemäß einer sechsten Ausführungsform, wobei das Einführen des Fixationselements in die Gehörgangswandbohrung in drei unterschiedlichen Stadien dargestellt ist;
• Fig. 10a und 10b eine Ansicht wie Fig. 5a bzw. 5b, wobei jedoch eine siebte Ausführungsform der Erfindung dargestellt ist;
• Fig. 11a, 11b und 11e eine Ansicht wie die Fign. 9a bis 9c, wobei jedoch eine achte Ausfübrungsform der Erfindung dargestellt ist;
• Fig. 12a und 12b eine Schnittansicht eines nicht unter die Erfindung fallenden Fixationselements vor bzw. nach dem Einführen in eine Gehörgangswandbohrung;
• Fig. 13a und 13b eine perspektivische Ansicht entsprechend zu Fig. 12a bzw. 12b;
• Fig. 14 eine perspektivische Ansicht eines nicht unter die Erfindung fallenden Fixationselements; und
• Fig. 15 eine Ansicht wie Fig. 14, wobei jedoch ein alternatives, ebenfalls nicht unter die Erfindung fallendes Fixationselement dargestellt ist.

In the following the invention will be explained in more detail with reference to the accompanying drawings. Showing:

• Fig. 1a and 1b a sectional view of a fixation element according to the invention before or after penetration into a bore in the ear canal wall according to a first embodiment;
• Fig. 2 a view like Fig. 1a However, wherein the fixation element is shown in a side view;
• Fig. 3a a perspective view of a not falling under the invention fixation element, which in Fig. 3b and 3c is shown in cross-section before or after insertion into an ear canal wall bore;
• Fig. 4a and 4b a side view, partially in section, of a fixation element according to the invention during or after insertion into an ear canal wall bore according to a second embodiment;
• Fig. 5a and 5b a view according to Fig. 4a and 4b, respectively, but showing a third embodiment;
• Fig. 6a and 6b a view like Fig. 5a and Fig. 5b, however, showing a fourth embodiment of the invention;
• Fig. 7a and 7b a view like Fig. 5a and Fig. 5b, however, showing a fifth embodiment of the invention;
• Fig. 8 a view like Fig. 3a However, wherein alternative, also not falling under the invention fixation element is shown;
• Fig. 9a, 9b and 9c a side view, partially in section, of a fixation element according to the invention according to a sixth embodiment, wherein the insertion of the fixation element is shown in the ear canal wall bore in three different stages;
• 10a and 10b a view like Fig. 5a and Fig. 5b, however, showing a seventh embodiment of the invention;
• Fig. 11a, 11b and 11e a view like that FIGS. 9a to 9c however, an eighth embodiment of the invention is shown;
• Fig. 12a and 12b a sectional view of a not falling under the invention fixation element before or after insertion into an ear canal wall bore;
• Fig. 13a and 13b a perspective view corresponding to Fig. 12a or 12b;
• Fig. 14 a perspective view of a not falling under the invention fixation element; and
• Fig. 15 a view like Fig. 14 However, wherein an alternative, also not falling under the invention fixation element is shown.

In the FIGS. 1a, 1b and 2 a first embodiment of a fixation element 10 is shown, which has a substantially circular cylindrical portion 12 and an adjoining flange-like portion 14 with a contact surface 16. The flange-like portion 14 projects in the radial direction with respect to the cylindrical portion 12 and surrounds a sound sensor. The cylindrical portion 12 and the flange portion 14 are preferably formed as a silicone sheath, wherein the cylindrical portion 12 encloses a provided with a sound receiving element 32, such as a membrane, housing part 34 of the sensor. The sound receiving element is provided at the free end 18 of the cylindrical portion 12 and is not provided with a sheath.

The cylindrical portion 12 is provided with two circumferential, axially spaced-apart sealing lips 20 and 22, which consist of elastic material and taper towards the free end 18. The sealing lip 20 is close to the free End 18 provided while the sealing lip 22 is provided in the central region of the cylindrical portion 12. The sealing lips 20, 22 are, like the rest of the fixation element 10, preferably made of silicone.

The sensor is connected via not shown electrical connections to the electronics of an implantable hearing system.

The fixation element 10 is designed for implantation into a bore 26 that traverses the rear auditory canal wall 24. On the side facing the auditory canal 30, the osseous canal wall 24 is covered by the auditory canal skin 28.

During the implantation of the fixation element 10, the cylindrical portion 12 is inserted from the side of the ear canal wall 24 facing away from the auditory meatus 28 into the bore 26. The outer circumference of the sealing lips 20 and 22 is greater than the inner circumference of the bore 26. Due to the taper of the sealing lips 20 and their elastic training, the sealing lips 20 and 22 are compressed in the radial direction inwardly, causing elastic restoring forces acting radially outward , When the cylindrical portion 12 according to Fig. 1b is completely inserted into the bore 26, the free end 18 with the membrane 32 is approximately flush with the provided with the auditory meatus 28 side of the ear canal wall 24. Due to the elastic restoring forces the sealing lips 20 and 22 are sealingly against the wall of the bore 26 , wherein the sealing lips 20, 22 are formed by appropriate choice of material and Abmessungs so that the restoring forces are large enough to prevent the fixation member 10 can move in the direction of the auditory meatus 28 side remote from the ear canal wall 24. The sealing lips 20, 22 are further designed so that they can fold away radially inwardly during insertion of the cylindrical portion 12 into the bore 26 by the forces occurring in the direction of the side facing away from the auditory meatus 28 side of the ear canal wall 24. By this with respect to the insertion asymmetric design of the sealing lips 20, 22 is achieved that the expended for inserting the cylindrical portion 12 into the bore 26 force is substantially less than the expended for pulling force, whereby a leaving the bore 26 can be prevented.

The sealing lip 22 is arranged in the axial direction so that it rests in the inserted state near the end remote from the auditory meatus end 28 of the bore 26 on the bore wall in order to ensure the most uniform distribution of force through the bore 26.

At the in Fig. 1b shown position, the abutment surface 16 of the flange-like portion 14 abuts against the side remote from the auditory meatus 28 side of the ear canal wall 24, thereby preventing the fixation element 10 can move further in the direction of the auditory canal 30. In this way, a fixation of the sound pick-up sensor in the ear canal wall 24 in both directions is achieved by the interaction of the sealing lips 20, 22 and the contact surface 16. By means of their elasticity, the sealing lips 20, 22 are able to provide for a balance of diameter variations or diameter deviations, ie the diameter of the bore 26 may be within a certain tolerance range, within which the sealing lips 20, 22 for a good seal of the bore 26 and provide sufficient fixation of the fixation element 10 in the bore 26.

In the FIGS. 3a to c is a not falling under the invention fixing member 110 is shown, which has a cylindrical portion 112 which is provided at a free end 118, on which the sound inlet membrane 32, with a circumferential, radially projecting elastic flange portion or a brim 136, while at the other end a flange-like portion 114 is provided with a contact surface 116. From the flange 114, an elongate section 138 leads away in the radial direction in which the electrical connections for the sensor run. The cylindrical portion 112 is provided at its outer periphery with axially extending web-like protruding members 140 of elastic material, which are formed so as to give a wavy contour in the circumferential direction (see Fig. 3b ). The outer diameter of the cylindrical portion 112 is greater in the region of the web-like protruding elements 140 than the inner circumference of the bore 26 in the ear canal wall 24, as long as the fixation element 110 is not used. The elements 140 are evenly distributed in the circumferential direction.

The circumference of the flange 136 and its elasticity are chosen so that the flange 136 can be passed through the bore 26 therethrough. In this case, the flange 136 initially sets on insertion into the bore 26 to the rear. The folded over flange 136 forms a tapered portion which facilitates the insertion of the portion 112 with the web-like protruding members 140, which are compressed in the radial direction upon entering the bore 26. After exiting at the auditory side end of the bore 26 of the flange 136 takes again in Fig. 3a shown form, wherein the flange 136 rests with its underside under the auditory canal skin 28 to the auditory side of the ear canal wall 24. In the inserted state, the in Fig. 3c is shown, the web-like protruding elements 140 are compressed in the radial direction with respect to the non-inserted state, whereby elastic restoring forces arise, on the one hand cause a certain fixation of the cylindrical portion 112 in the axial direction of the bore 26 and on the other hand, a centering of the fixation member 110 in the Bore 26 effect. In particular, diameter fluctuations or diameter deviations of the bore 26 can thereby be compensated for within a certain tolerance range by the elasticity of the web-like elements 140.

Provide additional fixation, as already mentioned, the flange 136 and the flange-like portion 114, which bear against the opposite sides of the ear canal wall 24.

In Fig. 8 is also a not falling under the invention modification of the fixation element according to Fig. 3a shown, wherein the web-like protruding elements 140 are provided with slots 150 which are seen in the axial direction approximately V-shaped, each element 140 having two axially offset from each other arranged such slots 150 is provided. The open side of the slots 150 is directed to the flange 136 having the end of the cylindrical portion 112 toward. The effect of the slots 150 is essentially that due to the elasticity of the elements 140, the respective boundary of the slot 150 closer to the flange 136 (ie, in FIG Fig. 8 the upper boundary of each slot 150) by the abutment against the wall of the bore 26 acts as an abutment, the withdrawal of the cylindrical portion 112th prevented from the bore 26, wherein the force required to insert the portion 112 is substantially less than the force required to pull out.

That in the FIGS. 4a and 4b illustrated fixation element 210 differs from the previously described embodiments essentially in that the cylindrical portion or nozzle 212 is provided with a circumferential bulge 220 made of elastic material which is formed so that when inserted fixation element 210 into a corresponding counterpart in the Bore wall engages. For this purpose, the bore 226 is provided in the middle wall of the ear canal wall 24 with a circumferential recess or undercut 222, which corresponds in contour to the bead-like bulge 220 on the nozzle 212, but the recess 222 is dimensioned slightly smaller than the bulge 220, which act in the inserted state elastic restoring forces, which ensure a tight fit of the fixation member 210.

The bulge 220 lies approximately in the middle of the neck 212, so that when the fixation element 210 is inserted, the free end 218 of the fixation element 210 is approximately flush with the side of the ear canal wall 24 facing the auditory meatus 28. The abutment surface 216 of the flange-like portion 214 abuts the other side of the ear canal wall 24 and provides additional fixation of the fixation member 210 by preventing movement thereof toward the ear canal 30. The bulge 220 ensures by its symmetrical design for a fixation of the fixation element 210 in both directions. However, when there is a flange-like portion 214 with abutment surface 216, it is not necessary for the protrusion 220 and undercut 222 to be symmetrical. Rather, it is sufficient if the bulge 220 so engages the undercut 222, that only the withdrawal from the bore 226 is prevented, for example by the bulge 220 in the free end 218 facing end tapers much slower than at the other end.

The insertion of the fixation element 210 into the bore 226 is made possible by the elasticity of the bulge 220.

The FIGS. 5a and 5b show a fixation element 310, which, in contrast to the embodiments described so far, consists of two separate parts 320 and 322, which are brought into firm engagement only in the ear canal bore 26. The main part 320 surrounds the sound sensor as in the previously described embodiments and comprises a circular cylindrical portion 312, to which a flange-like thickened portion 314 with a contact surface 316 connects. At the free end of the cylindrical portion 312, the sound receiving membrane 32 is provided. The fastening part 322 comprises a sleeve-like section 330, to which a circumferential, radially projecting flange section 336 adjoins. The sleeve-like portion 330 is provided with extending from its free end in the axial direction, circumferentially distributed slots 332 and has in its central region on its inner side a circumferential nose 334, which is formed as a dent of the wall of the sleeve-like portion 330. The inner diameter of the sleeve-like portion 330 is selected so that the sleeve-like portion 330 can be slid over the free end of the cylindrical portion 312 of the main body 320, however, spreading the sleeve-like portion 330 from its free end, causing elastic return forces. which provide for a firm engagement of the sleeve-like portion 330, in particular its nose 334, with the peripheral surface of the cylindrical portion 312, which is formed substantially as a smooth surface.

The fastening part 322 may be made of a biocompatible metal, e.g. Titanium, or be made of a suitable plastic to achieve the required elastic restoring forces.

The implantation of the fixation element 310 takes place in such a way that the attachment part 322 is introduced into the auditory canal 30 and placed on the side of the bore 26 facing the auditory meatus 28, while the main part 320 is placed on the other side of the bore 26. Subsequently, the two parts 320, 322 are moved towards each other in the axial direction and enter the bore 26, wherein the sleeve-like portion 330 pushes over the cylindrical portion 312 as described above and provides a firm engagement between the two parts 320 and 322 , Of course, the main part 320 or the fastening part 322 can first completely into the Bore 26 are introduced. In the implanted state, which in Fig. 5b Finally, the flange 336 of the fastening part 322 is located on the side of the auditory canal wall 24 facing the auditory meatus 28, while the contact surface 316 of the main part 320 abuts against the other side of the auditory canal wall 24, thereby securing the fixation element 310 in the bore 26 becomes.

The in the Figures 6a and 6b The embodiment of the fixation element 410 shown differs substantially from the embodiment just described by the way in which the fixed engagement in the axial direction between the two separate parts 420 and 422 of the fixation element 410 is produced. While in the embodiment according to the FIGS. 5a and 5b the engagement was made by a clamping mechanism, this is done in the embodiment according to the Figures 6a and 6b through a mutual latching. For this purpose, the cylindrical portion or neck 412 is provided on its outer side with a circumferential recess or groove 440, while the sleeve-like portion 430 is provided with an inner circumferential web-like projection 434, wherein the shapes of the projection 434 and the recess 440 are substantially complementary to each other. In the example shown, a rectangular contour is selected. However, it is also possible to choose a different geometry, for example a bevel in the Figures 6a and 6b downwardly facing side of the projection 434 to facilitate the insertion of the nozzle 412 in the sleeve-like portion 430. The end of the sleeve-like portion 430 facing away from the flange 436 is provided on its inside with a rounded portion 438 to facilitate the insertion of the neck 412.

The implantation takes place in the same way as in the embodiment according to FIGS FIGS. 5a and 5b , In the implanted state, as in Fig. 6b is shown, the projection 434 is latched to the recess 440, so that by conditioning the flange 436 and the contact surface 416 on the two sides of the ear canal wall 24, a fixation of the fixation element 410 in the bore 26 takes place.

The in the FIGS. 7a and 7b The modified embodiment shown differs from the embodiment according to Figures 6a and 6b essentially by the fact that the sleeve-like portion 530 of the fastening part 522 on the inside a circumferential recess 540 is provided, while the nozzle 512 is provided at its outer periphery with the circumferential ridge-like projection 534. In order to facilitate the insertion of the neck 512 into the sleeve-like portion 530, the circumferential projection 534 is provided on its side facing the fastening part 522 with a rounding 542. Further, the transition area between the nozzle 512 and the flange-like part 514 is formed as a gradual increase in diameter, while in the embodiment according to FIG Figures 6a and 6b and 5a and 5b of the nozzle is also formed in this area with a constant diameter. The transition area is in the FIGS. 7a and 7b designated by the reference numeral 544.

The implantation of the fixation element 510 takes place analogously to that described with reference to FIG Figures 6a and 6b described embodiment.

The in the FIGS. 9a to 9c embodiment shown differs from the two-part fixation element embodiments described so far essentially in that the attachment part 622 is provided at both ends of the sleeve-like portion 630 with a radially outwardly projecting flange 636 and 646, respectively, which in the implanted state on both sides of the ear canal wall Abut 24, so that the fastening part 622 is a total of sleeve-like or formed as a spout. On its inner circumference of the sleeve-like portion 630 is provided with a circumferential recess or groove 640, which is rounded trough-like profile. In the region between the flange 636, which abuts the ear canal wall 24 in the implanted state on the side of the ear canal wall 24, and the recess 640, the inner circumference of the sleeve-like portion 630 is cylindrical, ie, of constant diameter, while the area between the recess 640 and the second flange 646, which abuts on the other side of the ear canal wall 24 in the implanted state, is formed conically with increasing diameter. This conical region bears the reference numeral 648. The fastening part 622 is made of elastic material, preferably silicone.

The nozzle 612 of the main part 620 is provided with a rounded in profile, on the outer circumference of the nozzle 612 circumferential web-like projection 634, which is complementary to the recess 640 is formed. Accordingly, the nozzle 612 has at its free end a cylindrical portion and between the projection 634 and the flange-like portion 614 has a conical portion 650 with increasing outer diameter.

During implantation is in accordance with Fig. 9b First, the fastener 622 introduced from the ear canal side in the bore 26, wherein the fixing member 622 is radially compressed prior to insertion, whereby the flange-like portion 646 can be easily pushed through into the bore 26 and therethrough. After passing the flange 646 lies in the in Fig. 9b shown manner to the remote from the auditory meatus 28 side of the ear canal wall 24 at. Alternatively, the fastening part 622 may be inserted into the bore 26 instead of from the side of the auditory canal from the side of the auditory canal wall 24 facing away from the auditory canal 30.

Subsequently, the main part 620 is inserted from the side of the ear canal wall 24 facing away from the auditory meatus 28 with the free end of the neck 612 into the fastening part until the projection 634 engages in the recess 640 and thereby the main part 620 is fixed with respect to the fastening part 622. At the in Fig. 9c illustrated end position abuts the abutment surface 616 of the flange-like portion 614 on the flange 646 of the fastening part 622. The free end of the nozzle 612 is approximately flush with the flange 636. The conical design of the portion 650 a certain compression of the fastening part 622 is achieved in the bore 26, resulting in an improved sealing effect and stronger fixation of the fastening part 622 in the bore 26 cares.

In the in the Figures 10a and 10b As shown, the fixing member 710 is also composed of a main part 720 and a fixing part 722, but the fixing part 722 is provided with a flange 746 only at one end of the sleeve-like portion 730, while at the other end, a circumferential elastic lip-like member 750 is provided. The bore 726 in the ear canal wall 24th is provided on the ear canal skin 28 side facing with a chamfer 727, while the rest of the bore is circular cylindrical. The lip-like element 750 is intended in the implanted state to rest in the chamfer 727, while the flange 746 is intended to bear against the side of the auditory canal wall 24 remote from the auditory meatus 28. The lip-like element 750 is in the uninteged state with respect to the insertion or the free end of the sleeve-like portion 730 from the rear, wherein the protruding part is curved like a handle in the radial direction inwardly. The outer diameter of the sleeve-like portion 730 is reduced in the region 752 which adjoins the lip-like member 750 to facilitate the folding back of the lip-like member 750 upon insertion into the bore 726. In this case, the fastening part 722 is inserted from the side of the ear canal wall 24 facing away from the auditory meatus 28 with the lip-like element 750 in advance in the bore 726, until finally the lip-like element comes to bear in the chamfer 727, wherein elastic restoring forces occur, which are large enough in order to prevent the fastening part 722 from moving back in the direction of the side of the auditory canal wall 24 facing away from the auditory canal skin 28.

In this position, the flange 746 comes into contact with the side of the auditory canal wall 24 facing away from the auditory meatus 28 and thus prevents the fastening part 722 from sliding further in the direction of the auditory canal 30.

The inner side of the sleeve-like portion 730 is formed so that the inner diameter increases toward the both ends of the sleeve-like portion 730, according to FIGS Fig. 10a these two areas are conical and meet in the central region of the sleeve-like portion 730, so that the inner diameter in the central region is minimal. In the region of the flange 746, a circumferential elastic angle member 754 is further provided as a reinforcement, which extends both in the sleeve-like portion 730 and in the flange 746 and forms an angle of slightly more than 90 ° and may for example consist of metal or a sufficiently strong plastic.

The main part 720 is provided with a circular-cylindrical neck 712, to which a flange-like portion 714 with a contact surface 716 connects. The nozzle 712 is inserted with its free end from the side facing away from the ear canal 30 of the ear canal wall 24 in the hole 726 positioned in the fastening part 722 until the free end of the neck 712 is flush with the ear canal 28 facing side of the ear canal wall 24 and the Bearing surface 716 rests against the flange 746. By the waist of the inner side of the sleeve-like portion 730, which ensures that the minimum inner diameter in the central region is smaller than the outer diameter of the nozzle 712, and in particular by the action of the angular element 754, which is compressed by the insertion of the nozzle 712 so that elastic restoring forces act, is provided for a jamming between the nozzle 712 and the sleeve-like portion 730, which prevents a slipping back of the main part 720 and thus causes the fixation of the main part 720 in the fastening part 722 and thus in the bore 726.

The FIGS. 11a to 11c show a modification of this principle, wherein the fixation element 810 is integrally formed instead of two parts. In this embodiment, the neck 812 of the fixation member 810 is provided at its free end with the circumferential lip-like member 850. The neck 812 is introduced into the side of the ear canal wall 24 facing away from the auditory meatus 28 in the bore 726 provided with a bevel 727 on the side facing the auditory meatus 28.

In Fig. 11b For example, the state of the lip-like member 850 when passing the circular cylindrical portion of the bore 726 is shown. It can be seen that the lip-like element 850 is folded backwards as seen in the insertion direction and lies substantially flat in the region 852 with a reduced outer diameter, whereby the insertion of the nozzle 812 is facilitated.

Upon reaching the in Fig. 11c illustrated end position is the lip-like element 850 in the chamfer 727, wherein it assumes a handle-like state due to the increase in diameter of the bore 726 in the chamfer 727 again. The abutment surface 816 of the flange portion 814 is located in the Fig. 11c shown state at the of the Auditory canal skin 28 on the opposite side of the ear canal wall 24 to prevent further slipping of the neck 812 in the ear canal 30, so that the in Fig. 11c shown position is maintained, in which the free end of the neck 812 is substantially flush with the ear canal skin 28 facing side of the ear canal wall 24. On the other hand, the abutment of the lip-like element 850 in the chamfer 727 prevents the neck 812 from slipping back in the direction of the side of the auditory canal wall 24 facing away from the auditory meatus 28, so that a sufficient fixation of the fixation element 810 in the bore 726 is achieved.

The Figures 12a, 12b . 13a and 13b show a one-piece embodiment of a non-falling under the invention fixing element 910. Here, at the free end of the nozzle 912, which is formed substantially as a circular cylinder, a lamella provided, which consists of circumferentially arranged lamellae 920, with one end 922 so on attached to the periphery of the nozzle 912 are that they are hinged around this end 922. In this case, the lamellae are fastened to a wire loop 924 running around the neck. The attachment can optionally be designed such that by means of suitable elements, eg coil springs (not shown), the lamellae 920 a biasing force is impressed, which the lamellae 920 of the in Fig. 12a shown position to the in Fig. 12b shown biased position, ie the biasing force acts so that the slats, seen from the free end of the nozzle 912 forth, are folded backwards. The fins are preferably made of metal and are evenly distributed in the circumferential direction.

Before insertion into the bore 26, the slats 920, seen from the free end of the nozzle 912, forward in the in the FIGS. 12a and 13a shown position folded and held in this position. In this case, the free end of the fins 920 radially inward. In this position, the fixation element 910 with the lamellae is inserted from the side of the ear canal wall 24 facing away from the auditory meatus 28 into the bore 26 until the free end 918 of the neck 912 lies approximately flush with the side of the auditory canal wall 24 facing the auditory meatus 28 like this in Fig. 12b is shown. In this case, the contact surface 916 of the flange-like portion 914, located at the nozzle 912 adjoins, on the side remote from the auditory meatus 28 side of the ear canal wall 24, thereby preventing that the nozzle 912 slips further in the direction of the auditory canal 30. In this position, the fins 920, if necessary, supported by a bias at its attachment point to the wire loop 924, backwards and come to rest on the ear canal 28 side facing the ear canal wall 24. This position is in the Figures 12b and 13b shown, wherein the fins 920 form a laminar composite. Supported by a biasing force acting on the slats 920, the auditory canal skin 28, which may be located above the slats 920, prevents the slats 920 from flipping up again so that the fixation element 910 is prevented from moving in the direction away from the side of the auditory meatus 28 Ear canal wall 24 to slide out of the bore 26. In this way, the fixation element 910 is fixed in the bore 26. Preferably, according to Fig. 13b the fins 920 are formed so that they overlap in the position when they rest against the ear canal wall 24 at their edges like a tile to effect a seal of the bore 26.

In the Figures 14 and 15 two further fixation elements not covered by the invention are shown, in which one or both flanges are replaced by a plurality of retaining tabs distributed in the circumferential direction.

In the fixation element according to Fig. 14 a circular cylindrical portion 60 of an element 70 is provided with a circumferential flange-like portion 62, which is formed as a resilient brim, preferably of silicone, and is provided in a central portion of the cylindrical portion 60. At the free end 64 of the cylindrical portion 60, a flange-like portion is provided which consists of four circumferentially distributed retaining tabs 66 which protrude radially outwards at about 90 ° and are distributed uniformly over the circumference. Below the retaining tabs 66 a recess 68 is provided in each case, which is dimensioned according to the respective retaining tab 66 and this allows it to fold into the recess 68 to the rear (seen from the free end 64) to insert the cylindrical portion 60 in a corresponding Ear canal wall hole to facilitate. For this purpose, the retaining tabs 66 are formed elastically. After passing through the hole, the retaining tabs 66 fold back into the in due to the elastic restoring forces FIG. 14 shown position and cause in this way by conditioning on the ear canal wall fixation of the cylindrical portion 60. To enable this folding back, the free end 64 of the portion 60 has pushed a piece beyond the end of the bore 26 out into the ear canal 30 become. The brim 62 managed a bit far into the bore 26 and works away because of their elasticity backwards away. After the Zückklappen the retaining tabs 66, the portion 60 is pulled back a piece until the bottom of the tabs 66 abuts the ear canal wall. The brim 62 now abuts the other side of the ear canal wall to completely fix the cylindrical portion 60 in the bore.

At the in Fig. 14 The element 70 shown is preferably a hollow cylinder into which the main part enclosing the sound sensor is inserted and locked or latched therein as described, as in the above-described two-part embodiments with fastening part and main part. Alternatively, the housing of the sound sensor may be glued inside the element 70 prior to insertion, so that it is then a one-piece embodiment.

In the Fig. 15 The embodiment shown differs from the embodiment according to FIG Fig. 14 essentially in that the brim 62 is replaced by a second set of retaining tabs 80, which are formed analogously to the first set of retaining tabs 66, but offset from them by approximately 45 °. In this case, for the retaining tabs 80 also recesses 82 are provided, in which the lower retaining tabs 80 can dip when the free end 64 is pushed a bit far into the ear canal to effect the unfolding of the upper retaining tabs 66.

"Flange" or "flange" or "flange" etc. is intended in this application to designate an element which protrudes at about 90 degrees from a cylindrical portion radially outwardly and is provided at least on one side with a preferably substantially planar contact surface. In this case, the element around the cylindrical portion circumferentially, ie be formed with approximately constant outer radius, or the outer radius can depend on the (rotational) angle, for example in the manner of a wavy outer contour. In extreme cases, the flange-like element can even be interrupted be, ie, for example, consist only of individual circumferentially distributed tabs.

The term "circulating" in connection with "circulating element" or the like should not exclude that certain interruptions, e.g. Slots or the like, may be provided in the element.

By "neck" is meant a section which may be both substantially cylindrical, in particular circular-cylindrical, and may also have tapers or widenings, in particular in the form of conical sections and the like.

In principle, combinations of the embodiments are possible. Thus, for example, the Verrastungs- or Verklemmungsmechanismen described in each case for individual embodiments with two-part fixation element for all other embodiments with two-part fixation element can be used. Furthermore, features of the one-piece fixation element embodiments may also be used in two-part fixation element embodiments, e.g. on the outer circumference circumferential bulges, sealing lips and the like for fixing and / or sealing engagement with the bore wall instead of or in addition to flange-like sections which rest against the auditory canal wall. In addition, all described as one-piece as two-part embodiments can be modified by the described in the described one-piece embodiments as a nozzle or cylindrical portion portion is formed as a separate sleeve-like part, in which a nozzle of a main part, which encloses the sensor, before or during implantation inserted and locked or jammed.

In the one-part embodiments of the fixation element, ie in the embodiments in which the fixation element has a neck which rests at least partially directly on the bore wall, wherein a certain elasticity is required, is suitable as a material, for example, a biocompatible plastic with a Shore A Hardness of 20 to 70, which may be mainly silicones or polyurethanes.

In the case of the two-part embodiments, this choice of material also applies to the part of the fixation element which comprises the sleeve-like section and bears against the bore wall. In these two-part embodiments, the portion having the neck (and the sensor) to be inserted into the sleeve-like portion may be made less elastic than in the one-piece embodiments, using as materials, at least for the neck, then, for example, biocompatible metals, e.g. Titanium, or harder plastics come into question.

Claims (38)

1. A fixation element for an implantable microphone, wherein the fixation element (12, 210, 722, 810) comprises an essentially cylindrical portion (12, 212, 730, 812) adapted to be inserted into a bore (26, 226, 726) which crosses the wall (24) of the auditory canal, said cylindrical portion, at least in an implanted state of the fixation element, surrounding an outer circumferential portion of a housing part of the microphone, which housing part is provided with a sound receiving member (32, 24), characterized in that said cylindrical portion (12, 212, 730, 812) includes at least one elastic region (20, 22, 220, 750, 850) of increased outer diameter, said elastic region adapted to provide, by contacting the wall of said bore by elastic restoring forces, for a friction which is sufficiently high to fix said cylindrical portion in at least one of the two axial directions of said bore (26, 226, 726).
2. The fixation element of claim 1, wherein said region of increased diameter is defined by a circumferentially extending sealing member (20, 22) which is adapted to sealingly contact the wall of the bore upon said cylindrical portion (12) having been inserted into the bore (26).
3. The fixation element of claim 2, comprising at least two of such sealing members (20, 22) which are axially spaced from each other.
4. The fixation element of claim 3, wherein sealing members (20, 22) are designed such that the restoring forces are sufficient to prevent movement of the fixation element (10) towards the side of the wall (24) of the auditory canal remote from the skin (28) of the auditory canal.
5. The fixation element of claim 4, wherein the outer circumference of the sealing members (20, 22), when not inserted, is larger than the inner circumference of said bore 26).
6. The fixation element of claim 5, wherein the sealing members are sealing lips (20, 22).
7. The fixation element of claim 6, wherein the sealing lips (20, 22) are adapted to fold inwardly in the direction of the side remote from the skin (28) of the auditory canal by action of the forces caused by inserting the cylindrical portion (12) into the bore (26).
8. The fixation element of claim 7, wherein the sealing members (20, 22) are tapered at the side thereof facing the skin (28) of the auditory canal.
9. The fixation element of one claims 3 to 8, wherein a first one (20) of said sealing members is disposed at the end of the cylindrical portion (12) which faces the skin (28) of the auditory canal.
10. The fixation element of claim 9, comprising a pair of sealing members (20, 22) wherein a second one (22) of said sealing members is axially spaced from said first sealing member so as to contact, in the implanted state, the wall of the bore near the end of the bore (26) remote from the skin (28) of the auditory canal.
11. The fixation element of one of claims 2 to 10, wherein the cylindrical portion (12) is connected to a flange portion (14) of increased diameter, said flange portion, in the implanted state, contacting the side of the wall of the auditory canal remote from the skin (28) of the auditory canal.
12. The fixation element of claim 1, wherein the cylindrical portion (212) is provided, in a central region thereof, with a circumferentially extending bulging (220) which, in the implanted state of the fixation element, is adapted to engage a correspondingly circumferentially extending recess (222) in the wall of the bore.
13. The fixation element of claim 12, wherein the engagement of the bulging (220) with the recess (222) provides for fixation of the microphone.
14. The fixation element of one of claims 12 and 13, wherein the bulging (220) is bead-shaped.
15. The fixation element of one of claims 12 to 14, wherein the cylindrical portion (222) is connected to a flange portion (214) which is adapted to contact, in the implanted state, the side of the wall (24) of the auditory canal remote from the skin (28) of the auditory canal.
16. The fixation element of claim 1, wherein the cylindrical portion (730, 812) is provided at one end thereof with a circumferentially extending, elastic, lip member (750, 850) which, in the implanted state of the fixation element (720, 722, 810), is adapted to rest in a chamfer (727) provided at the end of the bore (726) facing the skin (28) of the auditory canal, the lip member being structured so that elastic restoring forces acting thereon are sufficient to prevent the fixation element from moving in the direction of the side of the wall (24) of the auditory canal which is remote from the skin of the auditory canal.
17. The fixation element of claim 16, wherein the lip member (750, 850) projects rearwardly with respect to the direction of introduction.
18. The fixation element of claim 17, wherein the outer diameter of the cylindrical portion (730, 812) is reduced in the region (752, 852) adjacent to the lip member (750, 850) to facilitate folding back of the lip member during introduction into the
19. The fixation element of one of claims 16 to 18, wherein the cylindrical portion (730, 812) is provided at the other end thereof with a flange member (746, 814) which, in the implanted state, contacts the side of the wall (24) of the auditory canal which is remote from the skin (28) of the auditory canal.
20. The fixation element of claim 19, wherein the cylindrical portion is defined by a sleeve portion (730) of a fixing member (722), and wherein a stud (712) of a main member (720) is adapted to be inserted into said sleeve portion, said stud enclosing the housing part which is provided with the sound receiving member.
21. The fixation element of claim 20, wherein the fixing member (722) is designed for introduction into the bore (727) from the side remote from the wall (24) of the auditory canal.
22. The fixation element of one of claims 20 and 21, wherein the inner diameter of the sleeve portion (730) increases in the direction of both ends of the sleeve portion.
23. The fixation element as claimed in claim 22, wherein the inner side of the sleeve portion (730) is conical at both end regions thereof.
24. The fixation element of claim 23, wherein the conical regions meet each other in the central region of the sleeve portion (730).
25. The fixation element of one of claims 20 to 24, wherein the fixing member (722) is reinforced in the area of the flange member (746) by a circumferentially extending
    elastic angle member (754) which extends in both the sleeve portion (730) and the flange member (746).
26. A fixation element for an implantable microphone, said fixation element (310, 410, 510, 610) comprising a first member (320, 420, 520, 620) which has a stud (312, 412, 512, 612) which is adapted for insertion into a bore (26) which crosses the wall (24) of the auditory canal and which encloses a housing part of the microphone at the outer circumference thereof, which housing part is provided with a sound receiving member (32), characterized in that the fixation element (310, 410, 510, 610) comprises a second member (70, 322, 422, 522, 622) comprising a sleeve portion (60, 330, 430, 530, 630) and a first flange portion (66, 336, 436, 536, 636), said sleeve portion being adapted to be slipped, starting with one end thereof, over the free end of said stud (312, 412, 512, 612) and to be fixedly engaged with the stud for preventing at least relative axial movement between the stud and the sleeve portion, and said first flange portion being provided at the other end of the sleeve portion and being adapted to contact, in the implanted state of the fixation element, the side of the wall (24) of the auditory canal facing the skin (28) of the auditory canal.
27. The fixation element of claim 26, wherein the stud (312, 412, 512, 612) is provided at one end with a flange portion (314, 414, 514, 614), said flange portion being adapted to contact, in the implanted state of the fixation element, the side of the wall (24) of the auditory canal remote from the skin (28) of the auditory canal.
28. The fixation element of one of claims 26 and 27, wherein the sleeve portion (330) is elastic in radial direction and is adapted to be expanded by introduction of the stud (312) into the sleeve portion, and wherein elastic restoring forces of the expanded sleeve portion provide for said fixed engagement.
29. The fixation element as claimed in claim 28, wherein the sleeve portion (330) is provided with circumferentially spaced slots (332) which start from said free end and which extend in axial direction.
30. The fixation element of one of claims 28 and 29, wherein the sleeve portion (330) is provided in a central region thereof with a nose (334) which extends in circumferential direction on the inner side of the sleeve portion and which, in the implanted state of the fixation element (310), contacts the outer circumference of the stud (312) to provide for said fixed engagement.
31. The fixation element of one of claims 26 and 27, wherein the sleeve portion (430, 530, 630) and the stud (412, 512, 612) are adapted for mutual locking engagement for providing said fixed engagement.
32. The fixation element of claim 31, wherein the sleeve portion (530, 630) is provided at the inner side thereof with a circumferentially extending recess (540, 640), and
    wherein the stud (512, 612) is provided at the outer circumference thereof with a circumferentially extending land-like bulging (534, 634) which, in the implanted state of the fixation element (510, 610), extends into said recess.
33. The fixation element of claim 31, wherein the stud (412) is provided at the outer circumference thereof with a circumferentially extending recess (440), and wherein
    the sleeve portion (430) is provided at the inner side thereof with a circumferentially extending land-like bulging (434) which, in the implanted state of the fixation element (410), extends into said recess.
34. The fixation element of one of claims 31 to 33, wherein in the region of the free end of the sleeve portion (430, 530, 630) of the second member the inner diameter increases.
35. The fixation element of claim 26, wherein a second flange portion (62, 646) is provided at that end of said sleeve portion (60, 630) of the second member (70, 622) which is adapted to be slipped over the free end of said stud (612) onto the stud, said second flange portion contacting, in the implanted state of the fixation element (610), the side of the wall (24) of the auditory canal remote from the skin (28) of the auditory canal.
36. The fixation element of claim 35, wherein the first flange portion is comprised of a plurality of circumferentially spaced holding tongues (66).
37. The fixation element of one of claims 35 and 36, wherein the second flange portion is comprised of a plurality of circumferentially spaced holding tongues (80).
38. The fixation element of claim 35, wherein the stud (612) comprises a conical section (650), the diameter of which increases towards the end opposite of the free end of the stud.

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