Ossicular prosthesis having a longitudinally perforated bight

Abstract

A passive ossicular prosthesis has a sound-conducting prosthesis body with a first coupling element for mechanical connection to the incus, malleus, or an actuator end piece of an active hearing aid at one end. The bight is made of a strip-shaped metallic material, partially open toward the outside via a gap-type opening and is intraoperatively crimped in the middle ear for permanent attachment. There is a second coupling element at the other end of the prosthesis body for connection to a further component of the ossicular chain or directly to the inner ear. The bight includes elongated perforations with longitudinal axes extending, in the implanted state, along a curved trajectory at a right angle or slant relative to an axis parallel to the longitudinal axis (a) of the enclosed object to reduce spring action and stiffness and markedly reduce the force to be applied for the crimping.

Claims

1. A passive ossicular prosthesis designed to replace or bridge at least one component of a human ossicular chain, comprising: a sound-conducting prosthesis body with a first coupling element designed in a form of a bight at one end and a second coupling element at another end; wherein the bight is made of a strip-shaped metallic material, is partially open toward an outside via a gap-type opening, is configured to enclose at least one of: the at least one component of the human ossicular chain, an actuator end piece for mechanical connection to the long process of incus, the manubrium of malleus, and an elongated actuator end piece of an active hearing aid, post-operatively encloses at least one of: the long process of incus, the manubrium of malleus and the actuator end piece in a non-positive manner and, intraoperatively is deformable using crimping tongs in the middle ear for fixation and permanent attachment of the first coupling element to at least one of: the long process of incus, the manubrium of malleus, or the actuator end piece; wherein the second coupling element is configured for mechanical connection to a further component or parts of a component of the ossicular chain or directly to the inner ear; and wherein the bight made of strip-shaped metallic material comprises a plurality of elongated perforations, longitudinal axes of which are configured to extend, in an implanted state of the ossicular prosthesis, along a curved trajectory at a right angle or at a slant relative to an axis that is parallel to at least one of: a longitudinal axis of the long process of incus, the manubrium of malleus or the actuator end piece.

2. The ossicular prosthesis according to claim 1, wherein the elongated perforations in the strip-shaped metallic material have through-slits that are straight in the flat state of said strip-shaped metallic material.

3. The ossicular prosthesis according to claim 2, wherein the through-slits have two parallel lateral borders in the longitudinal direction thereof and have consistent slit widths along the longitudinal extension.

4. The ossicular prosthesis according to claim 1, wherein the bight comprises at least two parallel rows of elongated perforations that are spaced apart, one behind the other, in the direction of the respective longitudinal axes thereof.

5. The ossicular prosthesis according to claim 4, wherein the elongated perforations all have the same size.

6. The ossicular prosthesis according to claim 4, wherein the elongated perforations are disposed in a row to be staggered in the longitudinal direction relative to the elongated perforations of an adjacent row.

7. The ossicular prosthesis according to claim 1, wherein the bight has an insertion projection at at least one of: a free end of the strip-shaped metallic material, and at the gap-type opening that facilitates the bending or compression of the bight by use of crimping tongs.

8. The ossicular prosthesis according to claim 7, wherein the insertion projection of the bight is offset relative to the curved parts thereof, which curved parts are configured to enclose at least one of: the long process of incus, the manubrium of malleus and the actuator end piece in the implanted state of the ossicular prosthesis, such that the insertion projection extends away from the longitudinal axis of the long process of incus, the manubrium of malleus, or the actuator end piece, respectively.

9. The ossicular prosthesis according to claim 1, wherein the elongated perforations in the bight are produced by laser cutting.

10. The ossicular prosthesis according to claim 1, wherein the second coupling element is designed as a piston for engagement in the inner ear.

11. The ossicular prosthesis according to claim 1, wherein the ossicular prosthesis is composed entirely or partially of a material having memory effect, superelastic properties or both.

12. The ossicular prosthesis according to claim 11, wherein the material is made of Nitinol.

13. The ossicular prosthesis according to claim 1, wherein the prosthesis body comprises at least one joint, more particularly a ball joint.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) Further features and advantages of the invention will become apparent from the description of embodiments that follows, with reference to the attached figures, wherein:

(2) FIG. 1: presents a schematic spatial depiction an embodiment of the ossicular prosthesis according to the invention standing upright and tilted to the side;

(3) FIG. 2 shows the embodiment according to FIG. 1, lying down, as viewed from the back side; and

(4) FIG. 3 shows the embodiment according to FIG. 1 in a side view as seen in the direction parallel to a position of a longitudinal axis of the long process of incus, the manubrium of malleus, or the actuator end piece, in the implanted state of the prosthesis.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

(5) The following is a detailed description of example embodiments of the invention depicted in the accompanying drawings. The example embodiments are presented in such detail as to clearly communicate the invention and are designed to make such embodiments obvious to a person of ordinary skill in the art. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present invention, as defined by the appended claims.

(6) FIG. 1 depicts an ossicular prosthesis 10 according to the invention, which comprises a shank-shaped, elongated, sound-conducting prosthesis body 13, which comprises a first coupling element 11 at one end. The first coupling element 11 is designed in the form of a bight made of a strip-shaped metallic material. The bite encloses the desired component of the ossicular chain or the actuator end piece and is partially open toward the outside via a gap-type opening 14 for mechanical connection to the long process of incus (=“incus”), the manubrium of malleus (“malleus”), or an elongated actuator end piece of an active hearing aid. The bight post-operatively encloses the long process of incus, the manubrium of malleus, or the actuator end piece in a non-positive manner.

(7) The component of the ossicular chain or the actuator end piece to be enclosed by the bight is not shown in the drawings. Merely shown, in a graphic depiction, is the longitudinal axis a of the long process of incus, the manubrium of malleus, or the actuator end piece to be enclosed, in the position thereof relative to the ossicular prosthesis 10 in the state thereof implanted in the middle ear, as a dash-dotted line in FIG. 2 and as a point in FIG. 3, as an axis extending perpendicularly through the plane of the drawing.

(8) Located at the other end of the prosthesis body 13 is a second coupling element 12, as shown. Second coupling element 12 can be embodied in diverse geometric shapes for mechanical connection to a further component or parts of a component of the ossicular chain or as shown, as a piston for insertion directly into the inner ear.

(9) The ossicular prosthesis 10 is characterized in that the bight, which is made of a strip-shaped metallic material, comprises a plurality of elongated perforations 15a, 15b, the longitudinal axes of which each extend (in the implanted state of the ossicular prosthesis 10) along a curved trajectory at a right angle or at a slant relative to an axis that is parallel to the longitudinal axis a of the long process of incus, the manubrium of malleus or the actuator end piece enclosed by the bight. The elongated perforations 15a, 15b in the bight of the first coupling element 11 are produced by laser cutting.

(10) In the ossicular prosthesis 10, the first coupling element 11 is configured such that the bight has an insertion projection 16 at a free end of the strip-shaped metallic material, at the gap-type opening 14. The insertion projection 16 facilitates the bending or compression of the bight by use of crimping tongs. The insertion projection 16 of the bight is offset relative to the curved parts thereof, which enclose the long process of incus, the manubrium of malleus, or the actuator end piece in the implanted state of the ossicular prosthesis 10, such that said insertion projection extends away from the longitudinal axis a of the long process of incus, the manubrium of malleus, or the actuator end piece.

(11) In the embodiment shown, the elongated perforations 15a, 15b in the strip-shaped, metallic material have through-slits, which are straight in the flat state of the strip-shaped, metallic material and which have two parallel lateral borders in the longitudinal direction thereof and have consistent slit widths along the longitudinal extension.

(12) As an alternative thereto, the through-slits may taper in the longitudinal direction thereof and have slit widths that continuously diminish.

(13) In other embodiments, the elongated perforations in the strip-shaped metallic material may have through-slits that extend in a serpentine or zigzag or meandering manner in the flat state of said strip-shaped metallic material.

(14) The bight as shown comprises two parallel rows of elongated perforations 15a, 15b, which are spaced apart, one behind the other, in the direction of the respective longitudinal axes thereof and all have the same size. Also as shown, the elongated perforations 15a, 15b are disposed in a row in the longitudinal direction so as to be staggered relative to the elongated perforations 15a, 15b of an adjacent row. In other embodiments of the invention, it is possible to provide more than two rows of parallel, elongated perforations.

(15) For that matter, in other embodiments of the invention, prosthesis body comprises at least one joint, in particular, a ball joint.

(16) The mass distribution of the individual parts of an ossicular prosthesis according to the invention is calculated depending on a desired, specifiable frequency response of sound conduction in the middle ear such that it is possible to tune the sound propagation properties in an individualized manner. This can be achieved by way of trimming masses that can be clipped to the ossicular prosthesis.

(17) The ossicular prosthesis 10 as shown is made entirely or partially of a material having memory effect and/or having superelastic properties, such as Nitinol. The invention, however, is not limited to being made with Nitinol but may be made by other metals or metal composites.

(18) As will be evident to persons skilled in the art, the foregoing detailed description and figures are presented as examples of the invention, and that variations are contemplated that do not depart from the fair scope of the teachings and descriptions set forth in this disclosure. The foregoing is not intended to limit what has been invented, except to the extent that the following claims so limit that.