WO2017221256A1 - Ossicular replacement prosthesis - Google Patents

Abstract

Embodiments of an ossicular prosthesis are described, based on original morphological measurement results collected by the inventors from hundreds of ossicles. Prosthetic devices are often used in middle ear surgery to replace the entire or part of the ossicular chain (e.g., due to trauma, cholesteatoma, otosclerosis, tympanosclerosis, etc.). Typically, structure depends on one or only a few anthropometric data, retrieved intraoperatively. A potential advantage of an ossicular prosthesis designed according to morphological measurement results as described herein is improved auditory function by more closely restoring the original anatomy.

Description

OSSICULAR REPLACEMENT PROSTHESIS

RELATED APPLICATIONS

This application claims the benefit of priority under 35 USC § 119(e) of U.S. Provisional Patent Application No. 62/353,734 filed June 23, 2016; the contents of which are incorporated herein by reference in their entirety.

FIELD AND BACKGROUND OF THE INVENTION

The present invention, in some embodiments thereof, relates to the field of ossicular chain reconstruction prostheses, and more particularly, but not exclusively, to ossicular prostheses which at least partially replace structure of a stapes.

Prosthetic devices are often used in middle ear surgery to replace the entire or part of the ossicular chain (e.g., due to trauma, cholesteatoma, otosclerosis, tympanosclerosis, etc.). While stapedotomy as well as stapedectomy procedures have been quite successful, other ossicular chain reconstruction surgical techniques have been less successful at fulfilling the goal of restoring desirable hearing, and are associated with a long list of potential side effects.

The human stapes bone is the third among the three ossicles of the middle ear. It is an asymmetric U-shaped bone connecting the malleus and incus, comprising the first two ossicles, to the inner ear. The direct connection from the stapes to these two bones is to the incus.

Anatomical features of the incus include the articular surface with malleolar head, the long limb of the incus (also called the long process of the incus), and the lenticular process at the articulation with the stapedial head (e.g., at the lenticular fossa) to form the incudo-stapedial joint (ISJ).

Current prosthetic devices are used in surgical procedures replacing part or all of the ossicles connected to the stapes footplate by a substantially linear, single limb structure. Drilling a hole in the stapedial footplate may be involved in placement of such a prosthesis. SUMMARY OF THE INVENTION

There is provided, in accordance with some embodiments of the present disclosure, an ossicular prosthesis for anchoring to a stapedial footplate of a human ear, the ossicular prosthesis comprising: a proximal head region configured to anchor to a proximal portion of the middle ear; and at least one distal end joined to the proximal head region through a connecting member; wherein the at least one distal end is positioned by the connecting member to anchor at a center-offset position near an edge of the stapedial footplate when the proximal head region is anchored to the proximal portion of the middle ear.

In some embodiments, the connecting member comprises a curved portion between the proximal head region and the at least one distal end.

In some embodiments, the curved portion has a curvature of about 102°.

In some embodiments, the distal end anchors to a region positioned at a base of the posterior crus.

In some embodiments, the ossicular prosthesis comprises two separately anchoring distal ends, each configured to anchor at a different center-offset position near an edge of the stapedial footplate.

In some embodiments, at least one of the two separately anchoring distal ends anchors to the footplate by pressing into a fossa of a crus of the footplate.

In some embodiments, each of the two separately anchoring distal ends anchors to the footplate by pressing into a respective fossa of a respective crus of the footplate.

In some embodiments, the two distal ends are offset from being directly opposite one another by between about 20° and 45°, relative to a central axis extending perpendicularly from the footplate and through the position of the proximal head region, when the ossicular prosthesis is anchored within a middle ear.

In some embodiments, the offset is about 25°.

In some embodiments, the proximal head region is positioned and configured to attach to a lenticular process of an incus bone of the human ear.

In some embodiments, the proximal head region extends to a tympanic membrane of the human ear when the two distal ends are anchored to the stapedial footplate. There is provided, in accordance with some embodiments of the present disclosure, an ossicular prosthesis for anchoring to a stapedial footplate of a human ear, the ossicular prosthesis comprising a body having: a proximal head region configured to anchor to a proximal portion of the middle ear; and two distal ends; wherein the two distal ends are configured and positioned to anchor at separate stapedial footplate regions respectively positioned at a base of a native anterior crus and a base of a native posterior crus.

In some embodiments, upon anchoring of the prosthesis within a middle ear: a central portion of each distal end lies along one of two respective coplanar axes, each coplanar axis extending: substantially parallel to a surface of the footplate attached to an oval window of the ear, and perpendicular to an outer periphery of the footplate, from an outer periphery location located along an extent of a base of a stapedial crus; wherein the two respective axes intersect at an angle between about 20° and 45°.

In some embodiments, the angle of intersection is about 25°.

In some embodiments, a limb of the ossicular prosthesis extending between the proximal head region and one of the distal ends comprises a curvature of about 102°.

In some embodiments, at least one of the distal ends anchors to the footplate by pressing into a fossa of the footplate.

In some embodiments, at least one of the distal ends anchors to the footplate by insertion into a hole drilled in the respective region positioned at the base of the native crus.

In some embodiments, both of the distal ends anchor to the footplate by pressing into a fossa of the footplate.

There is provided, in accordance with some embodiments of the present disclosure, an ossicular prosthesis for anchoring to a stapedial footplate of a human ear, the ossicular prosthesis comprising a body having: a proximal head region configured to anchor to a proximal portion of the middle ear, wherein the proximal head region is centered around a proximal-distal axis extending perpendicularly from the stapedial footplate; and two distal ends configured and positioned to anchor at separate stapedial footplate regions; wherein a different respective axis extends from a center of each distal end to intersect perpendicularly with the proximal-distal axis, and the different respective axes intersect at an angle of at least 20°. There is provided, in accordance with some embodiments of the present disclosure, an ossicular prosthesis for a human ear, the ossicular prosthesis comprising two contact elements spaced from one another through a connecting member to form an anchor sized and shaped for anchoring insertion of the two contact elements each to a respective fossa or hollow at the junction of a portion of a stapes crus with a stapes footplate of a human ear.

In some embodiments, the connecting member comprises two limb members, each terminating at a respective distal end comprising one of the contact elements, and each joined at a respective proximal end to a head in a proximal region of the ossicular prosthesis.

In some embodiments, the proximal region of the ossicular prosthesis comprises a hollow shaped to receive contact with an incus bone of a human ear.

In some embodiments, the head of the ossicular prosthesis is sized to extend to a tympanic membrane of the human ear when the contact elements are anchored to the stapes footplate.

In some embodiments, the distal ends of the limb members are shaped and positioned to be simultaneously received at a respective fossa of the stapes footplate.

In some embodiments, the contact elements are positioned to define two respective axes; each of the two respective axes extends in a common plane substantially perpendicular to the stapes footplate, and between a respective one of the distal ends and a position on the plane defined by a projection from the hollow along a third axis perpendicular to the plane; and the two respective axes meet at an angle displaced about 40 degrees from intersection in opposing directions.

In some embodiments, an angle of between 135° and 145° is defined within a geometrical plane substantially perpendicular to the stapes footplate; the angle being defined within the plane by geometric projection of a connecting angle onto the plane; and wherein the connecting angle is defined by geometrical rays extending from a geometrical vertex at a radial center of the hollow to a radial center of each distal end.

In some embodiments, the two limb members are positioned to define two respective axes; each of the two respective axes extends in a common plane substantially perpendicular to the stapes footplate, and from a respective one of the distal ends in a direction substantially perpendicular to the periphery of the stapes footplate from the distal end; and the two respective axes meet at an angle displaced about 40 degrees from intersection in opposing directions.

In some embodiments, each axis is defined to pass through the geometrical center of its respective distal end within the common plane.

In some embodiments, one of the limb members comprises a bend of about 102° through a region extending between the proximal and distal ends of the limb member.

In some embodiments, at least one of the distal ends comprises a radially expanded region of its respective limb member, the radially expanded region being sized to fittingly insert to the respective fossae at which it is received.

In some embodiments, at least one of the distal ends comprises a cylindrical region shaped to fittingly insert to a drilled hole in the stapes footplate.

In some embodiments, the hollow is defined by two portions of the proximal region configured to open to receive and then close to enclose a portion of an incudal process.

In some embodiments, the two portions defining the hollow are joined through a hinge.

In some embodiments, the two portions defining the hollow are fitted to each other by a plurality of pins.

In some embodiments, the ossicular prosthesis comprises a hinged securing member attached to the proximal region, and moveable to swing into a position extending over the hollow to secure an incudal process to the hollow.

In some embodiments, the hinged securing member comprises a bracket secured at bracket ends on two sides of the proximal region, and the bracket is curved between the bracket ends to allow the bracket to swing over and clamp a portion of the incudal process to secure a lenticular process to the hollow.

In some embodiments, provided as part of a kit of a plurality of such ossicular prostheses, the kit comprises ossicular prostheses having at least two different corresponding distances extending between the two limb members.

In some embodiments, the kit comprises ossicular prostheses having at least two different corresponding heights. In some embodiments, the kit comprises ossicular prostheses having at least five different corresponding distances extending between the two limb members, and at least five different corresponding heights.

There is provided, in accordance with some embodiments of the present disclosure, a method of fitting an ossicular prosthesis to a stapes footplate, the ossicular prosthesis comprising two limb members joined to a proximal region of the ossicular prosthesis at a respective proximal end of each limb member, and the method comprising: pressing toward each other a respective distal end of each of two limb members; moving the distal ends into a receiving region of the stapes footplate; and releasing the limb members so that each presses against an inner surface of the receiving region.

In some embodiments, the receiving region is defined between two crurae remnants of the footplate, and each distal end presses against an inner surface of a respective one of the two crurae remnants.

In some embodiments, the receiving region comprises at least one receiving niche cut into the footplate to receive at least one of the distal ends.

In some embodiments, the method comprises removing a portion of stapes superstructure including at least part of a crurae of the stapes to form a hollow comprising a portion of the receiving region; and wherein the distal end of one of the released limb members occupies a portion of the receiving hollow.

In some embodiments, the removing comprises drilling the stapes footplate.

In some embodiments, the limb members press elastically against the inner surface of the receiving region.

There is provided, in accordance with some embodiments of the present disclosure, an ossicular prosthesis for a human ear, the ossicular prosthesis comprising a contact element sized to fit into a hole drilled into a stapes footplate, a curved limb extending proximally from the contact element, and a securing member at a proximal end of the curved limb; wherein the curved limb is sized and shaped to extend proximally from the contact element, positioned at a peripheral portion of the footplate, and centrally toward a position over a more central portion of the footplate, where the securing member is positioned to be secured to an incudal process. There is provided, in accordance with some embodiments of the present disclosure, an ossicular prosthesis for a human ear, the ossicular prosthesis being sized and shaped to extend between an incudal process and at least one peripheral portion of a stapes footplate, for transmitting vibratory movements therebetween.

In some embodiments, the peripheral portion comprises a root of a crus remnant.

There is provided, in accordance with some embodiments of the present disclosure, a stapedial prosthesis, configured to interconnect between a direct connection to a lenticular process of an incus and a stapedial footplate.

In some embodiments, the direct connection comprises a socket sized for receiving the lenticular process.

In some embodiments, the socket is reversibly expandable to receive and retain the lenticular process.

In some embodiments, the stapedial prosthesis comprises an retaining loop near the socket, sized and positioned to loop over an incudal long process to retain the lenticular process within the socket.

Unless otherwise defined, all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and/or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example, and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced. In the drawings:

FIG. 1 is a schematic representation of a human stapes bone, according to some aspects of the present disclosure;

FIG. 2 is a schematic representation of a human incus bone, according to some aspects of the present disclosure.

FIGs. 3 and 4A-4B schematically represent the footplate of a stapes, including footplate regions of a heel and toe (also referred to herein as a "hallux"), according to some embodiments of the present disclosure;

FIG. 5 schematically represents a prepared portion of a native stapes, prepared for receiving an ossicular prosthesis, according to some embodiments of the present disclosure;

FIG. 6 schematically illustrates an ossicular prosthesis comprising a U shaped structure, according to some embodiments of the present disclosure;

FIG. 7 schematically illustrates insertion of ossicular prosthesis to prepared portion, according to some embodiments of the present disclosure;

FIG. 8 schematically illustrates a variant ossicular prosthesis held to footplate by a drilled hole, according to some embodiments of the present disclosure;

FIGs. 9-10 schematically illustrate attachment of ossicular prosthesis to the incudal lenticular process, according to some embodiments of the present disclosure;

FIG. 11 schematically illustrates details of the proximal region of an ossicular prosthesis, according to some embodiments of the present disclosure;

FIG. 12 schematically illustrates details of the proximal region of an ossicular prosthesis, according to some embodiments of the present disclosure;

FIGs. 13A-13B schematically illustrate details of a proximal region of an ossicular prosthesis attached to the long process of the incus via lenticular process by a "bucket-handle" structure to reconstruct the original ISJ, according to some embodiments of the present disclosure;

FIG. 14 schematically illustrates an ossicular prosthesis attached to the long process of the incus via a "tongue-and-groove" type connection at proximal region, according to some embodiments of the present disclosure; FIG. 15 schematically illustrates a single-limbed ossicular prosthesis which attaches to a hole drilled near an edge of a stapes footplate, according to some embodiments of the present disclosure;

FIG. 16 schematically illustrates a total ossicular chain reconstruction prosthesis, according to some exemplary embodiments of the present disclosure;

FIGs. 17A-17B schematically represent cross-sectional views of the ossicular prosthesis of Figure 7 inserted to a prepared stapedial footplate, according to some embodiments of the present disclosure;

FIG. 18 schematically illustrates vibrational modes of a stapes in attachment to an oval window of an inner ear, according to some embodiments of the present disclosure;

FIG. 19 schematically represents a middle ear, to which a stapedial ossicular prosthesis has been implanted, according to some embodiments of the present disclosure;

FIGs. 20A-20D schematically represent other configurations for the limbs of an ossicular prosthesis, according to some embodiments of the present disclosure;

FIG. 20E schematically represents an overhead view of an ossicular prosthesis which connects to a prepared footplate at regions away from heel and/or toe (away from the crus bases), according to some embodiments of the present disclosure; and

FIGs. 21A-21E schematically represent different ways of securing a ossicular prosthesis to a prepared stapedial footplate, according to some embodiments of the present disclosure.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

The present invention, in some embodiments thereof, relates to the field of ossicular chain reconstruction prostheses, and more particularly, but not exclusively, to ossicular prostheses which at least partially replace structure of a stapes. Overview

An aspect of some embodiments of the present disclosure relates to ossicular prostheses which connect at one or more acentric footplate locations to the footplate of a native stapes.

In some embodiments, an ossicular prosthesis comprises a total ossicular chain reconstruction prosthesis (TORP). In some embodiments, an ossicular prosthesis comprises a partial ossicular chain reconstruction prosthesis (PORP).

Certain existing ossicular prostheses comprise single limb and/or piston designs which tend to transmit acoustic energy to the inner ear in a piston like motion (e.g. , substantially along a single axis of energy transmission to the inner ear). However, in recent years, more complex motion of the native stapes was observed in experiments using laser Doppler vibrometry. The observed motion comprises a rotating motion composed of piston motion together with rocking on the long and short axis of the stapes footplate. Herein, "rocking" motions are understood to include motions where one side of a stapedial footplate and/or the oval window to which it attaches is relatively elevated (in a proximal direction), while the other side is relatively depressed (in a distal direction). There may be different (optionally, simultaneous) rocking motion components associated with each axis of the footplate. Herein "piston" or "pistoning" motions are understood to include motions which are substantially along a proximal/distal axis extending substantially perpendicularly from a stapedial footplate and/or oval window (e.g., defined in a resting state). Conventions used herein for defining the proximal/distal axis are discussed in relation to Figure 1, herein.

In some embodiments of the invention, an ossicular prosthesis connects at one or more acentric locations of a stapedial footplate. This provides a potential advantage for driving vibrations comprising a rocking component, by exciting movement of the stapes (and/or the oval window to which the stapes normally connects) from an eccentric position. Optionally, the excited motion comprises both rocking and pistoning motions.

An aspect of some embodiments of the present disclosure relates to ossicular prostheses comprising a two-limbed (e.g. , U-shaped) structure which replaces at least a portion of the superstructure of a native stapes.

Certain existing ossicular prostheses are constructed to restore relatively simple anthropometric data (e.g. , an overall stapedial length only), retrieved intraoperatively. The existing ossicular prostheses may, for example, comprise only one limb connecting between a footplate of a native stapes and a tympanic membrane or incudal long process. Potentially, however, these devices fail to adequately restore function due to differences (e.g., oversimplification) from the original anatomy, which may be due, for example, to variation across age, body size, sex, and/or population differences.

In some embodiments, a partial ossicular chain reconstruction prosthesis (PORP) or total ossicular chain reconstruction prosthesis (TORP) is shaped to restore one or more anatomically typical relationships to the stapes footplate itself and/or its relationship with other middle ear structures such as the incus, malleus or tympanic membrane. In some embodiments, a two-limbed ossicular prosthesis structure is provided.

In some embodiments, the restored anatomically typical relationship comprises restoration of an angle of curvature of the superstructure in passing from a first limb member of the ossicular chain reconstruction prosthesis to a second limb member of the ossicular chain reconstruction prosthesis; e.g. , an angle differing from a 180° (straight) angle by about 40°. In some embodiments, the angle is within the range of 40° +1°, +2°, +4°, +5°, or another greater, lesser or intermediate tolerance value.

In some embodiments, connection between an ossicular chain reconstruction prosthesis and a native incus bone is placed at a position laterally (that is, when projected perpendicularly from its actual position to a plane substantially parallel to the footplate of the stapes) in a position which is anatomically stereotypical. For example, the position is stereotypical and defined based on a normal relationship of two or more anatomical landmarks. For example, a heel and a toe are optionally defined on a footplate by the circumferential positions of the crurae; axes are optionally defined extending through the centers of the heel and toe perpendicularly from the perimeter of the footplate, and the point of intersection of these axes is used to define the plane- projected position of the ossicular prosthesis contact with a native incus bone when the ossicular prosthesis is implanted.

In some embodiments, an ossicular chain reconstruction prosthesis comprises a channel and/or hollow which can be opened to receive and then closed to capture a lenticular process of an incus to which it connects. In some embodiments, an ossicular prosthesis comprises an expanded proximal end (e.g., expanded to form a wheel-shaped structure, optionally a spoked wheel-shaped structure) which is positionable to contact a tympanic membrane and/or malleus long process. Optionally, the contact is with or without cartilage in between the prosthesis and the tympanic membrane.

An aspect of some embodiments of the present invention relates to ossicular prostheses in which one or more of the distal ends of the ossicular prosthesis anchor to a stapedial footplate by an elastically maintained pressure and/or interference fit to a crus fossa and/or crus remnant.

An aspect of some embodiments of the present invention relates to a method for fitting an ossicular chain reconstruction prosthesis comprising two limb members. In some embodiments, the fitting comprises compressing the limb members together (e.g. bending them elastically toward one another), placing their distal ends within an interior region of a native footplate of a stapes, and then releasing them. Optionally, they exert outward elastic force after the releasing, clamping themselves against interior surfaces of the stapes. Optionally, they are held in place by interlocking with parts they contact. Distally, for example, they optionally interlock with fossae of or holes drilled into the stapes. Proximally, for example, they are held in place by contact with a long process of an incus or malleus, or by pressing against a tympanic membrane.

An aspect of some embodiments of the present disclosure relates to ossicular prostheses comprising a curved single-limbed structure which replaces at least a portion of the superstructure of a native stapes. In some embodiments, the single limb is substantially perpendicular where it terminates (distally) in a contact element at and/or against one crus of a footplate (for example, at a fossa of a crus). Optionally, the contact element is secured at the region of footplate contact, for example, by insertion to a hole drilled in the footplate (e.g., a hole of between about 0.4 mm and 0.6 mm diameter, or a hole within another range of diameters). Potentially, the substantially perpendicular part helps in the approach and/or attachment to the footplate.

In some embodiments, the single limb extends from the distal end both proximally and centrally (relative to the plane and position of the footplate) so that it reaches to a structure of the incus with which it connects (for example, a lenticular process or long process). Optionally, the single limb comprises a curve along its proximally-directed extent which defines the degree to which it extends centrally. In some embodiments, the curve defines an oblique angle along the limb of about 102°. Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and/or methods set forth in the following description and/or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways.

General Anatomical Relationships between a Stapedial Prosthesis and the Stapes, Incus, Malleus, and/or Tympanic Membrane

Reference is now made to Figure 1 which is a schematic representation of a human stapes bone 100, according to some aspects of the present disclosure.

Anatomical features of the stapes 100 include the lenticular fossa 102, head

(capitulum) 103, neck 104, genu of the posterior crus 106, internal groove 110, posterior crus 108, anterior crus 112 (herein the plural of crus is "crurae"), obturator foramen 114, and/or footplate 116. Herein, the head region 103 is referred to as occupying the more proximal end of the stapes {e.g., nearer to the tympanum in vivo), and the footplate is referred to as occupying the more distal end of the stapes {e.g., nearer to the oval window of the cochlea in vivo). The same proximal/distal convention applies, changed as necessary, to other ossicular bones and/or to ossicular prostheses described herein.

Herein, unless otherwise specified, a position "at an edge" of stapedial footplate 116 refers to a position within 100 μιη, 150 μιη, 200 μιη, 250 μιη, 500 μιη, or another smaller or intermediate distance from a periphery of the footplate (and more particularly, of a periphery lying substantially within a plane parallel to the oval window).

Herein, unless otherwise specified, a position "offset from the center" of a stapedial footplate 116, refers to a position offset from the geometrical center of the footplate by at least 500 μιη, 750 μιη, 1000 μιη, or another larger smaller or intermediate distance. Optionally, the geometrical center of the footplate is determined relative to a plane extending substantially parallel to the surface joining the footplate and the oval window. Optionally, the offset is determined relative to a geometrical center of a region defining the offset position, such as a cross-section of a peg or other connecting element. Reference is also made to Figure 2 which is a schematic representation of a human incus bone 200, according to some aspects of the present disclosure.

Anatomical features of the incus 200 include the articular surface with malleolar head 202, the long process 204 of the incus, and/or the lenticular process 206 for articulation with the stapedial head 103 (e.g. , at the lenticular fossa 102) to form the incudo- stapedial joint (IS).

The human stapes bone 100 is the third among the three ossicles of the middle ear. It is an asymmetric U-shaped bone connecting the mallets (not shown) and incus 200, comprising the first two ossicles, to the vestibule of the inner ear.

Current prosthesis devices used with surgical procedures replacing the stapes

100 are mostly linear, single limb structures. Placement of such structures typically departs from the natural anatomy. This departure comprises, for example, connecting to the long process of the incus 204, thus bypassing the original articulation between the incus 200 and the stapes 100. Drilling (e.g., center-drilling) of the stapedial footplate 116 may also be involved in placement of such structures.

In some embodiments of the present invention, an ossicular prosthesis (e.g. , one of the ossicular prostheses of Figures 6-13B described herein) is provided as an asymmetric U-shaped structure comprising two limbs attached to a superstructural curvature. In some embodiments, the ossicular prosthesis connects directly to the lenticular process of the incus 206. This provides a potential advantage by more nearly following the connectivity of the natural anatomy. Optionally, placing the ossicular prosthesis is done without drilling of the footplate 116. Optionally placing is without through-drilling of the footplate 116 (for example, in an absence of stapedial superstructure, the prosthesis can be placed without making a hole that extends completely through the stapes footplate 116). Optionally, the footplate is drilled through. In some embodiments, a drilling diameter is in the range of about 0.4 mm - 0.6 mm. Optionally, the ossicular prosthesis is bound (e.g., bonded to and/or pressed against) to the footplate so that sound transmitted through it reaches the inner ear via force transmission through the footplate.

A native stapes 100 is an asymmetrical U-shaped structure, with its asymmetry well expressed in the morphology of the capitulum 103 and footplate 116. As an outcome of their own anatomical studies, the inventors have determined principles of the structure of the stapes 100 which apparently have not been described previously, and which may be used, in some embodiments of the present invention, as a basis on which to determine measurements and/or features of a stapedial prosthesis.

Stapedial Prostheses and the Stapedial Footplate

Reference is now made to Figures 3 and 4A-4B, which schematically represent the footplate 116 of a stapes 100, including footplate regions of a heel 302 and toe 304 (also referred to herein as a "hallux"), according to some embodiments of the present disclosure.

Reference is also made to Figure 6, which schematically illustrates an ossicular prosthesis 600 comprising a U shaped structure, according to some embodiments of the present disclosure. In some embodiments, prosthesis 600 implements one or more typical anatomical traits determined from examination of native stapes 100 anatomy by the inventors, as is next described.

In some embodiments of the invention, an ossicular prosthesis 600 is constructed such that prosthetic structures (e.g., posterior and anterior limbs 608, 606) corresponding to the posterior and anterior crurae 108, 112 are configured to meet the footplate 116 at specific regions which the inventors name the heel 302 and the toe 304 of the footplate 116. The inventors have found that certain relationships between these anatomical points (previously undescribed to the knowledge of the inventors) are reproduced on hundreds of anatomical specimens they have examined.

In some embodiments of the invention, the toe 304 is defined to comprise the extent of the perimeter of the footplate at which the posterior crus is joined to it (e.g., at region 304A). Optionally, this includes a region just inside this extent, e.g., a region within about 150 μιη, 200 μιη, 250 μιη or another larger, smaller or intermediate distance from the perimeter. In some embodiments of the invention, the heel 302 is defined to comprise the extent of the perimeter of the footplate at which the anterior crus is joined to it (e.g., at region 302A), optionally including a region just inside this perimeter, e.g., a region within about 150 μιη, 200 μιη, 250 μιη or another larger, smaller or intermediate distance from the perimeter. In some embodiments, the region "just inside" the perimeter is interiorly limited by the interiorly connected region of a crus. Herein, the toe 304 and heel 302 are also referred to as the "base" of the posterior crus and anterior crus, respectively. A region "positioned at the base" (for either of toe 304 and heel 302) includes both the base itself, and a region of the footplate nearby, including an associated fossa. A region positioned at either base is optionally defined as comprising footplate positions within 100 μιη, 200 μιη, 250 μιη, 350 μιη, or another larger, smaller, or intermediate distance from the connecting crus-to-footplate cross- section.

In some embodiments of the current invention, an ossicular prosthesis 600 is constructed according to the measure of one or more anatomical relationships between the heel 302, toe 304, and footplate 116; believed to have been discovered by the inventors, and not previously reported. One expression of these anatomical relationships comprises an observation that the axes of the two (each axis 302B, 304B being substantially perpendicular to the perimeter of the footplate at the 302C, 304C centers of the respective heel region 302 and toe region 304) meet at an angle 305 displaced from meeting in directly opposing directions by an angle of at least 20°, and for example between about 20°-45°. In some embodiments of the invention, portion of an ossicular prosthesis replacing a stapedial superstructure includes connections which are positioned to restore angle 305. For example, the angle of displacement from full opposition 305 is about 25.0° + 2° (corresponding to an average and standard deviation of a sample of 63 measurements of this angle in anatomical samples, Figure 4B). Alternatively {Figure 4A), the angle of displacement is about 40.0°+2.2°, or another angle. The displacement angle may be alternatively described as an angle of "twist" or "torque" relative to a diametrically opposite arrangement. In the figure herein, connections of the distal ends of the ossicular prosthesis to footplates are shown making contact in regions at the bases of crurae of the footplate. However, it is to be understood that optionally connections are made to other footplate regions which lie along different (e.g., separated by 20° or more, optionally in the range of 20°-45°, and optionally about 25°) periphery-perpendicular axes. Using the regions of the crus bases as connection sites, however, has potential advantages for replicating auditory transmission properties and/or for ease and/or consistency of prosthesis placement.

In some embodiments, this angle is used to define for an ossicular prosthesis 600 a curvature of the superstructure of the stapes 100, the superstructure comprising the anterior and posterior crurae 108, 112, and other structures of the stapes 100 which they attach to the footplate 116. Optionally, the crossing point 306 of the axes 302B, 404B is positioned directly below the position of the incudo- stapedial joint, e.g. , directly below the geometrical radial center of the hollow of canal 605. In some embodiments, an ossicular prosthesis is constructed so that articulation with the prosthetic lenticular fossa 206 occurs over this crossing point 306.

In some embodiments of the invention, an ossicular prosthesis 600 is defined to have a structure (e.g. anterior limb 606) corresponding to the anterior crus 112, which is relatively straight (as in the native stapes 100), while a structure (e.g. , posterior limb 608) corresponding to the posterior crus 108 is curved as in the native stapes 100.

In some embodiments, the angulation 620 of the posterior limb 608 is shaped to conform with a typical anatomical angulation of an posterior crus 108, determined by the inventors to be about 102.2°+6.9° (n=30) at about equal distances from its root and from the capitulum 103. In some embodiments, angle 620 corresponds to a curvature between a more distal (and relatively straight) part 608B of a limb 608 and a more proximal part 608C (also relatively straight) of a limb 608. Optionally, the angle is about 102°, in imitation of the corresponding angle in native human stapes as measured by the inventors. It should be understood that due to foreshortening, the angle as drawn appears somewhat larger than 102° in two dimensions.

A potential advantage of the about 102° angle is to achieve more native stapes- like characteristics of vibration transmission to the oval window 204 from the head region 602, e.g., via rocking and/or rotational motions of the footplate in contact with the oval window; and/or due to resonance and/or sound impedance properties of the limb itself. This potentially includes more natural frequency response behavior, e.g. , transmitting of resonances which a strict longitudinal vibration might not transmit at the same amplitude.

In some embodiments of the invention, the superstructure of an ossicular prosthesis 600 includes a head region 602 which is hollowed out by a canal 605 that is opened towards the centrum of the prosthetic superstructure 607, corresponding to a feature observed by the inventors in the native stapes 100.

Reference is now made to Figure 5, which schematically represents a prepared portion 500 of a native stapes 100, prepared for receiving an ossicular prosthesis 600, according to some embodiments of the present disclosure. Reference is also made to Figure 7, which schematically illustrates insertion of ossicular prosthesis 600 to prepared portion 500, according to some embodiments of the present disclosure.

The inventors have observed two fossae 502, 504 brought about by the union of the crurae 108, 112 with the footplate 116. Optionally, ossicular prosthesis 600 is shaped to fittingly insert into fossae 502, 504, after removal (or due to absence) of portions of crurae 108, 112 leaving crurae remnants. Optionally, the crurae remnants comprise cut and/or broken surfaces 501, 503, for example as shown in Figure 7.

The native stapes 100 may be prepared for receiving an ossicular prosthesis, for example by accessing the middle ear using appropriate known otologic surgery tools and techniques (e.g. , through the ear canal from alongside the tympanic membrane), and performing a stapedectomy comprising removal (e.g., snapping, ablating, and/or cutting away) of existing stapedial superstructure, including detachment from the stapedial tendon.

In some embodiments, the two limbs 606, 608 of the ossicular prosthesis 600 are placed in the prepared portion 500 of the stapes 100 (after removal of the superstructure, or due to absence of the superstructure), between the remaining portions of fossae 502, 504. Optionally, placement comprises compressing the limbs 606, 608; placing their distal ends 606A, 608A into the fossae 502, 504; and releasing them to spring out again (e.g. , in the directions indicated by the arrowheads of double arrow 501 in Figure 7). Optionally, distal ends 606A, 608A are shaped to fittingly insert into fossae 502, 504, for example, bent, rounded, and/or expanded to fill and/or follow inner curves of the native fossae and/or the surface of the footplate 116 adjacent to the native fossae. In some embodiments, one or both of the distal ends 606A, 608A comprises a radially expanded region of its respective limb 606, 608; for example, but not only, a substantially spherical, ovoid (e.g. , ellipsoid), cylindrical, or other shape. In some embodiments, the expanded region protrudes to extend in an outward-facing direction laterally beyond an inward-protruding portion of the remaining crus 112, 108 above it, such that the prosthesis geometrically interlocks with the remaining native stapes anatomy and is held in place at least partially thereby. For example, the geometrical interlocking prevents pulling the ossicular prosthesis away from the baseplate without deforming the shape of one or the other. Optionally, the implant is simply placed, and remains held, for example, in compression between a stapedial footplate 116 and a tympanic membrane 252, malleus 250, and/or incus 200 (for example as described herein in relation to Figure 19).

In some embodiments, after release, the two limbs 606, 608 elastically expand (in directions 610). The prosthesis, in some embodiments, will hold itself in place, optionally without requiring drilling of the footplate 116. This is a potential advantage for avoidance of possible damage to the inner ear.

In some embodiments, the superstructure 607 of ossicular prosthesis 600 is extended (e.g., elongated in the shape of a rod, optionally terminating in an expansion such as a spoked wheel-like structure) to have a length and contacting surface suitable to contact and transmit vibrations from a tympanic membrane 252, potentially allowing sound transmission bypassing other bones of the ossicular chain (e.g., total ossicular replacement prosthesis, replacing missing/damaged bones).

Implantation Positions of an Ossicular Prosthesis and Interactions with Associated Anatomy

Reference is now made to Figures 17 A-17B, which schematically represent cross-sectional views of the ossicular prosthesis 600 of Figure 7 inserted to a prepared stapedial footplate, according to some embodiments of the present disclosure. The cross-sectional view of Figure 17 A shows a view cut parallel to the plane of the stapedial footplate (e.g., plane 1701 of Figure 7). The cross-sectional view of Figure 17B shows a view wherein the prepared stapedial footplate is cut perpendicular to that plane (e.g., plane 1702 of Figure 7). The two distal expansions at distal ends 606A, 608A are left uncut by the sectioning. It should be noted that parts of the remaining footplate crurae (e.g., regions 520A, 520B) extend over the expansions of distal ends 606A, 608A, potentially helping to retain them in place.

It can be understood from this that distal ends 606A, 608A may take any suitable shape, such as flaring bend, to allow interlocking with the remaining crurae portions, and not necessarily an expansion. It is noted that in some embodiments (e.g., ossicular prosthesis 800 of Figure 8), one or both of the distal ends 606A, 608A is replaced by a peg, and interlocking is assisted by preparation of the footplate 116, for example, by drilling a hole in it (e.g., mechanically and/or by laser). Also indicated in Figure 17 A are the axes 304B and 302B of the footplate 116, and crossing at crossing point 306; each defined, for example, as described in relation to Figures 4A-4B {e.g., angle 305 is at least 20°, and for example is in a range of 20°-45°, for example about 25°). In some embodiments, ossicular prosthesis 600 (or any other ossicular prosthesis described herein) is constructed so that articulation with the prosthetic lenticular fossa 206 occurs within the region 306A over crossing point 306. For example, head region 602 {Figure 6), and in particular canal 605 are positioned above the plane of the cross section over region 306A.

Apart from potentially providing mechanical advantage for exciting rocking vibrations for two different axes of the footplate 116, these connection placements also potentially help to provide increased stiffness to the overall structure, compared to footplate contact at one point, or compared to footplate contact at two regions diametrically opposite each other relative to the head region 602. Increased stiffness potentially has an acoustic transmission advantage by reducing acoustic impedance: e.g., the filtering of sound frequencies by dissipation and/or reflection.

Reference is now made to Figure 19, which schematically represents a middle ear 1900, to which a stapedial ossicular prosthesis 1905 has been implanted, according to some embodiments of the present disclosure. Ossicular prosthesis 1905 may be any of the stapedial ossicular prostheses described herein, for example, ossicular prosthesis 600, 800, 1300, 1400, 1450, 1500, or another ossicular prosthesis.

In the figure, native parts of middle ear 1900 include tympanic membrane 252, malleus 250, incus 200, oval window 254, round window 256, and stabilizing ligaments 257. Also shown is footplate 116 (for example, prepared from native stapes to a condition as shown in Figure 5). As shown stapedial ossicular prosthesis 1905 interconnects footplate 116 with the lenticular process 206.

Reference is now made to Figure 18, which schematically illustrates vibrational modes of a stapes 100 in attachment to an oval window 254 of an inner ear, according to some embodiments of the present disclosure.

It has been observed that the oval window in connection with a normal ossicular chain may assume vibratory modes other than a piston-like in-and-out motion, which are described herein as comprising "rocking" motions. The rocking motions, particularly combinations of rocking motions around two different axes, may additionally or alternatively manifest as rotating waves that precess completely or partially around a circumference of the oval window. Such non-pistoning modes potentially arise at the oval window itself, and/or are transmitted and/or transformed via the ossicular chain from similar vibratory modes of the tympanic membrane 252. Different frequencies may be associated with different vibrational modes, and/or have their energy distributed among different vibrational modes.

Indicated in Figure 18 are the perpendicular ("pistoning") vibration mode 1811, and two rocking mode vibration components: mode 1813 (representing tilting motions of the long axis of the stapedial footplate) and mode 1811 (representing tilting motions of the short axis of the stapedial footplate). The two rocking modes 1811, 1813 potentially combine to produce the appearance of rotational modes 1817, which may comprise vibrational waves rotating fully or partially around a circumference of oval window 254.

Ossicular implants which fail to replicate the connection geometry of a native stapes 100 may potentially also fail to excite these modes as faithfully as the native stapes 100. In turn, this may lead to attenuation of sound energy transmitted to the cochlea for exciting neural sensing activity. For example, a connection made only to the center of the oval window may lack sufficient mechanical advantage to faithfully excite certain rocking vibrations. It is also noted that entirely "in line" connection {e.g., connections made at directly opposite positions on either side of the long axis of footplate 116) potentially fail to transmit vibrational energy which falls perpendicular to the axis of connection.

Reference is now made to Figure 8, which schematically illustrates a variant ossicular prosthesis 800 held to footplate 116 by a drilled hole, according to some embodiments of the present disclosure.

In some embodiments, a portion of posterior limb 808 comprises a peg 802, which inserts into a hole 804 drilled in the footplate 116 by the surgeon (e.g., mechanically and/or by laser). This option provides a potential advantage for treating otosclerosis which involves footplate fixation. Compared to placement of a piston- driving single-limb prosthetic, drilling of the footplate 116 is performed in a location closer to the posterior crural fossa 502. Optionally, one limb (e.g., limb 808) is shaped to include a peg 802, while the other limb (e.g., limb 808) is shaped similarly to corresponding limb of ossicular prostheses 600. Alternatively, each of limbs 806, 808 comprise a peg 802. Optionally, the stapedial footplate is separately prepared (e.g. drilled) to receive each of the two pegs 802. The peg 802 may be held in place by friction fit, adhesive, and/or by the use of a small soft tissue graft.

Stapedial Prostheses and the Incus

Reference is now made to Figures 9-10, which schematically illustrate attachment of ossicular prosthesis 600, 800 to the incudal lenticular process 206, according to some embodiments of the present disclosure. In some embodiments, a socket in head region 602 is sized and shaped to admit a head (wider region) of the lenticular process, and to close around the neck (thinner region) of the lenticular process. Optionally, this configuration allows ball-and-socket rotation at the artificial joint this prepared, potentially helping to preserve some modes of acoustic transmission which a fixed or limited motion joint (e.g. , one axis only) might not transmit.

Fitting at the incudal/prosthesis joint can optionally be by snap fit (e.g. , made by pressing the two together from either side of the join region) and/or by another mechanism, for example as described in relation to Figures 11-15 herein.

It is noted that at least some currently available prosthetic devices fasten an ossicular prosthesis to the incus 200 by direct connection to the long process of the incus 204. This bypasses the original incudo-stapedial joint, rather than reconstructing it.

Optionally, peg 802 of ossicular prosthesis 800 is on either of limbs 806, 808, or on both, for example as described in relation to Figure 8. Peg 802 is sized and positioned to connect to (e.g., fittingly insert to) a hole 804 which may be drilled partially or fully through prepared portion 500 of the native stapes in either the heel or the toe region.

Reference is now made to Figure 11, which schematically illustrates details of the proximal region of an ossicular prosthesis 600, according to some embodiments of the present disclosure. In some embodiments, ossicular prostheses 600, 800 comprise a proximal region (head region 602) having two parts 603, 609 comprising respective grooves 604B, 604A, to which are attached a joining peg 604, acting as a hinge member allowing pivoting of parts 603 and 609. In some embodiments, grooves 604B, 604A comprise looped portions (not shown), and joining peg 604 passes through looped portions of either proximal region part so that the two proximal region parts 603, 609 are pivotably secured to one another. The looped portions are optionally alternately displaced along grooves 604A, 604B so that they interlock. Optionally, portions of a proximal region part opposite a loop on the other proximal region part are cut away to allow interlocking.

Reference is now made to Figure 12, which schematically illustrates details of the proximal region (head region 1302) of an ossicular prosthesis 1300, according to some embodiments of the present disclosure. In some embodiments, proximal region portions 1305, 1303 are connected by insertion of pins 1304 of one of the proximal region portions into receiving sockets 1304A of the other. Head portion 1303 is shown a second time in face-on view to illustrate sockets 1304A.

Reference is now made to Figures 13A-13B, which schematically illustrates details of a proximal region 1403 of an ossicular prosthesis 1400 attached to the long process of the incudal long process 204 via lenticular process 206 by a "bucket-handle" structure 1405 to reconstruct the original IS, according to some embodiments of the present disclosure.

In some embodiments, a proximal socket 1410 of ossicular prosthesis 1400 is sized to receive lenticular process 206. The "bucket handle" structure 1405 comprises a retaining loop attached to the proximal region 1403, and is sized to loop over a portion of incudal long process 204, so that the lenticular process 206 is retained within proximal socket 1410.

Reference is now made to Figure 14, which schematically illustrates an ossicular prosthesis 1400 attached to the long process of the incus 204 via a "tongue-and-groove" type connection at proximal region 1457, according to some embodiments of the present disclosure. In some embodiments, groove 1459 is shaped to fittingly accommodate a portion of an incus long process 204. Single-Limbed Ossicular Prosthesis

Reference is now made to Figure 15, which schematically illustrates a single- limbed ossicular prosthesis 1500 which anchors by attaching to a hole 804 drilled near an edge (for example, into the heel or toe) of a prepared stapes footplate 500, according to some embodiments of the present disclosure. In some embodiments, anchoring is to another position near an edge of the prepared stapes footplate 500, e.g., to a position within 100 μηι, 150 μηι, 200 μηι, 250 μηι, 500 μιτι, or another smaller or intermediate distance from a periphery of the footplate lying substantially within a plane parallel to the oval window. In some embodiments, anchoring is to an position offset from a center of the prepared stapes footplate 500, e.g., offset from the geometrical center of the footplate by at least 500 μηι, 750 μηι, 1000 μηι, or another larger smaller or intermediate distance. Optionally, the geometrical center of the footplate is determined relative to a plane extending substantially parallel to the surface joining the footplate and the oval window. Optionally, the anchor position is at a fossa of a crus, a region positioned at a base of a crus, or at another position at an edge of the footplate and offset from the center of the footplate.

In some embodiments, limb 1502 crosses between a stapes attachment element 1501, sized to fit into a hole drilled into footplate 500, and an incus attachment element 1504, for example a hook sized to hook over an incudal long process. Optionally, limb 1502 is bent so that hook 1504 is offset laterally toward the center of plate 500; e.g., so that it reaches to the relative position at which the head of a native stapes would connect to the incus.

Other Ossicular Prosthesis Configurations

Reference is now made to Figure 16, which schematically illustrates a total ossicular chain reconstruction prosthesis 1600, according to some exemplary embodiments of the present disclosure. In some embodiments, ossicular prosthesis 1600 extends from footplate 500 to contact the malleus 250 and/or tympanic membrane 252 over a surface defined by contact with wheel- shaped structure 1605. In some embodiments, wheel-shaped structure 1605 comprises a spoked rim attached to the main body of the prosthesis via a central hub. It is noted that the ossicular prosthesis 1600 may be extended (for example with a longer neck 1604 and/or limb(s) 1608) in order to reach targets more distant from the footplate 116 than the incus 200. Reference is now made to Figures 20A-20D, which schematically represent other configurations for the limbs 2002A, 2002B 2004A, 2004B, 2006, 2007 of an ossicular prosthesis, according to some embodiments of the present disclosure. The examples shown in these figures are of stapedial prostheses which connect, e.g. , proximally to a lenticular process 203 of an incus, and distally to the heel 302 and toe 304 of a prepared stapedial footplate 500. It is to be understood that the same limb configurations are optionally used with other designs of head region 2010 (proximal region), for example as described herein; optionally including designs which are extended, for example as described in relation to Figure 16, so as to act as a replacement for a larger part or all of the ossicular chain.

In some embodiments (Figure 20A), limbs 2002A, 2002B of ossicular prosthesis 2001 are joined more distally than is shown, for example, in ossicular prosthesis 600 of Figure 6 (e.g., they are shorter). In Figure 20A, limbs 2002A, 2002B are joined to more proximal connecting portions of head region 2010 by a relatively elongated neck 2021. In some embodiments, the join is even further distal, for example as shown in Figure 20B for limbs 2004A, 2004B and long neck 2022 of ossicular prosthesis 2003. In Figure 20C, an example of a short-limbed ossicular implant is shown where at least one of the limbs (as illustrated, limb 2007) is configured to insert into a hole pre-drilled into prepared stapedial footplate 500.

Figure 20D emphasizes that the head region 2010, and the distal bases of the limbs (e.g., limbs 2004A, 2004B, or any of the other limb pairs) are arranged (e.g., with angle 305 of at least 20°, and for example in a range between 20°-45°, for example about 25°) so that there are potentially "rocking" vibrations transmitted from the head region 210 which have components along both the long and short axes of the footplate (e.g., considering the footplate perimeter as defining long and short axes of an approximate ellipse). Viewing the plane of the stapedial foot face-on, the bases of the two limb pairs make contact with the plate at positions which are not co-linear along a line including the planar-projected position of the head region 2010 (stated another way, they are not diametrically opposite each other relative to head region 2010). Potentially, because of this arrangement, components of rocking around the short axis can occur at different frequencies than components of rocking around the long axis (while either and/or both are potentially different than frequency components along the proximal- distal axis).

It is noted that optionally the "U" between two limbs may be fully or partially filled in with material. Potentially, this produces increased stiffness, potentially decreasing acoustic impedance to a degree offsetting disadvantages of increased stapedial weight. It is also noted that contact between the distal ends of the prosthesis and the footplate is optionally made along the lateral inside of the remaining crus fragment, and/or upon the bottom surface of the fossa.

Reference is now made to Figure 20E, which schematically represents an overhead view of an ossicular prosthesis 2050 which connects to a prepared footplate 500 at regions away from heel 302 and/or toe 304 (away from the crus bases), according to some embodiments of the present disclosure. Use of this option may provide a potential advantage, for example, in case of a malformed footplate, while potentially preserving vibration transmission for two different "rocking" modes. In the option shown, both distal ends are formed with pegs for insertion in the peg-and-hole configuration described, for example, in relation to Figure 8.

Reference is now made to Figures 21A-21E, which schematically represent different ways of securing a ossicular prosthesis to a prepared stapedial footplate 500, according to some embodiments of the present disclosure. Proximally connecting superstructure has been suppressed in these drawings; it is to be understood that any of the connection types described herein (for example) are optionally used with the distal end anchoring mechanisms described in Figures 21A-21E.

Distal end 2105 of Figures 21 A, 21 B and 21 E is configured to clamp to {e.g., elastically snap-fit upon) a remaining fragment of a crus by pressing upon either side of the crus fragment, exerting forces in directions indicated by arrows 2106. The connector is optionally used, for example, as a single-connection anchor {Figure 21A), in a paired- connection anchor {Figure 21B), and/or in a mixed-connector anchor, for example, a peg connector 802 {Figure 21E; the peg connector 802 may be, for example, as described in relation to Figure 8, herein).

Distal end 2110 of Figures 21 , 21 D is configured to work in combination with another anchoring point of the same type {Figure 21C) and/or a different type such as a peg connector 802, (Figure 21D). Arrows 2111 show the direction of elastic compression which may be used to help secure the ends onto the prepared footplate 500.

A potential advantage of the externally-pressing distal end connection methods shown is to allow exerting rocking force from more lateral positions. This potentially assists in reconstructing the natural transmission of acoustic energy to the oval window.

Preconfigured Size Ranges of Stapedial Prostheses

In some embodiments of the invention, the prosthesis is provided in a range of sizes; for example, 5 sizes for the height, and 5 sizes for the distance between the U limbs, (defining in this example a total of 25 morphs). In some embodiments, a larger or smaller number of morphs are provided. Optionally, morphs specifically suited to female and male anatomy are provided. A potential advantage of providing a variety of sizes is to allow ready sizing to substantially any patient undergoing an ossicular chain reconstruction procedure. Insofar as the range of sizes is optionally discreetly defined, it may be a potential advantage to allow ready selection from a pre-manufactured range of options.

General

As used herein with reference to quantity or value, the term "about" means "within +10% of.

The terms "comprises", "comprising", "includes", "including", "having" and their conjugates mean: "including but not limited to".

The term "consisting of means: "including and limited to".

The term "consisting essentially of means that the composition, method or structure may include additional ingredients, steps and/or parts, but only if the additional ingredients, steps and/or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

As used herein, the singular form "a", "an" and "the" include plural references unless the context clearly dictates otherwise. For example, the term "a compound" or "at least one compound" may include a plurality of compounds, including mixtures thereof.

The words "example" and "exemplary" are used herein to mean "serving as an example, instance or illustration". Any embodiment described as an "example" or "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments and/or to exclude the incorporation of features from other embodiments.

The word "optionally" is used herein to mean "is provided in some embodiments and not provided in other embodiments". Any particular embodiment of the invention may include a plurality of "optional" features except insofar as such features conflict.

As used herein the term "method" refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.

As used herein, the term "treating" includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition.

Throughout this application, embodiments of this invention may be presented with reference to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as "from 1 to 6" should be considered to have specifically disclosed subranges such as "from 1 to 3", "from 1 to 4", "from 1 to 5", "from 2 to 4", "from 2 to 6", "from 3 to 6", etc. ; as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

Whenever a numerical range is indicated herein (for example "10-15", "10 to 15", or any pair of numbers linked by these another such range indication), it is meant to include any number (fractional or integral) within the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases "range/ranging/ranges between" a first indicate number and a second indicate number and "range/ranging/ranges from" a first indicate number "to", "up to", "until" or "through" (or another such range-indicating term) a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numbers therebetween.

Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting.

It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

Claims

WHAT IS CLAIMED IS:

1. An ossicular prosthesis for anchoring to a stapedial footplate of a human ear, the ossicular prosthesis comprising:

a proximal head region configured to anchor to a proximal portion of the middle ear; and

at least one distal end joined to the proximal head region through a connecting member;

wherein the connecting member is sized and shaped so that the distal end anchors at a center-offset position near an edge of the stapedial footplate when the proximal head region is anchored to the proximal portion of the middle ear.

2. The ossicular prosthesis of claim 1, comprising two separately anchoring distal ends, each configured to anchor at a different center-offset position near an edge of the stapedial footplate.

3. The ossicular prosthesis of claim 2, wherein at least one of the two separately anchoring distal ends anchors to the footplate by an elastic interference fit within a fossa of a crus of the footplate.

4. The ossicular prosthesis of claim 3, wherein each of the two separately anchoring distal ends anchors to the footplate by pressing into a respective fossa of a respective crus of the footplate.

5. The ossicular prosthesis of claim 2, wherein the two distal ends are offset from being directly opposite one another by between about 20° and 45°, relative to a central axis extending perpendicularly from the footplate and through the position of the proximal head region, when the ossicular prosthesis is anchored within a middle ear.

6. The ossicular prosthesis of claim 5, wherein the offset is about 25°.

7. The ossicular prosthesis of claim 1, wherein the connecting member comprises a curved portion between the proximal head region and the at least one distal end.

8. The ossicular prosthesis of claim 7, wherein the curved portion has a curvature of about 102°.

9. The ossicular prosthesis of claim 1, wherein the distal end anchors to a region positioned at a base of the posterior crus.

10. The ossicular prosthesis of any one of claims 1-6, wherein the proximal head region is positioned and configured to attach to a lenticular process of an incus bone of the human ear.

11. The ossicular prosthesis of any one of claims 1-6, wherein the proximal head region extends to a tympanic membrane of the human ear when the two distal ends are anchored to the stapedial footplate.

12. An ossicular prosthesis for anchoring to a stapedial footplate of a human ear, the ossicular prosthesis comprising a body having:

a proximal head region configured to anchor to a proximal portion of the middle ear; and

two distal ends;

wherein the two distal ends are configured and positioned to anchor at separate stapedial footplate regions respectively positioned at a base of a native anterior crus and a base of a native posterior crus.

13. The ossicular prosthesis of claim 12, wherein, upon anchoring of the prosthesis within a middle ear: a central portion of each distal end lies along one of two respective coplanar axes, each coplanar axis extending:

substantially parallel to a surface of the footplate attached to an oval window of the ear, and

perpendicular to an outer periphery of the footplate, from an outer periphery location located along an extent of a base of a stapedial crus; wherein the two respective axes intersect at an angle between about 20° and 45°.

14. The ossicular prosthesis of claim 13, wherein the angle of intersection is about 25°.

15. The ossicular prosthesis of claim 12, wherein a limb of the ossicular prosthesis extending between the proximal head region and one of the distal ends comprises a curvature of about 102°.

16. The ossicular prosthesis of any one of claims 12-15, wherein at least one of the distal ends anchors to the footplate by pressing into a fossa of the footplate.

17. An ossicular prosthesis for anchoring to a stapedial footplate of a human ear, the ossicular prosthesis comprising a body having:

a proximal head region configured to anchor to a proximal portion of the middle ear, wherein the proximal head region is centered around a proximal- distal axis extending perpendicularly from the stapedial footplate; and

two distal ends configured and positioned to anchor at separate stapedial footplate regions;

wherein a different respective axis extends from a center of each distal end to intersect perpendicularly with the proximal-distal axis, and the different respective axes intersect at an angle of at least 20°.

18. An ossicular prosthesis for a human ear, the ossicular prosthesis comprising two contact elements spaced from one another through a connecting member to form an anchor sized and shaped for anchoring insertion of the two contact elements each to a respective fossa or hollow at the junction of a portion of a stapes crus with a stapes footplate of a human ear.

19. The ossicular prosthesis of claim 18, wherein the connecting member comprises two limb members, each terminating at a respective distal end comprising one of the contact elements, and each joined at a respective proximal end to a head in a proximal region of the ossicular prosthesis.

20. The ossicular prosthesis of claim 19, wherein the proximal region of the ossicular prosthesis comprises a hollow shaped to receive contact with an incus bone of a human ear.

21. The ossicular prosthesis of claim 19, wherein the head of the ossicular prosthesis is sized to extend to a tympanic membrane of the human ear when the contact elements are anchored to the stapes footplate.

22. The ossicular prosthesis of any one of claims 20-21, wherein the distal ends of the limb members are shaped and positioned to be simultaneously received at a respective fossa of the stapes footplate.

23. The ossicular prosthesis of claim 19, wherein:

the contact elements are positioned to define two respective axes; each of said two respective axes extends in a common plane substantially perpendicular to the stapes footplate, and between a respective one of the distal ends and a position on the plane defined by a projection from the hollow along a third axis perpendicular to the plane; and the two respective axes meet at an angle displaced about 40 degrees from intersection in opposing directions.

24. The ossicular prosthesis of claim 22, wherein an angle of between 135° and 145° is defined within a geometrical plane substantially perpendicular to the stapes footplate; the angle being defined within the plane by geometric projection of a connecting angle onto the plane; and wherein the connecting angle is defined by geometrical rays extending from a geometrical vertex at a radial center of the hollow to a radial center of each distal end.

25. The ossicular prosthesis of claim 22, wherein:

the two limb members are positioned to define two respective axes; each of said two respective axes extends in a common plane substantially perpendicular to the stapes footplate, and from a respective one of the distal ends in a direction substantially perpendicular to the periphery of the stapes footplate from the distal end; and

the two respective axes meet at an angle displaced about 40 degrees from intersection in opposing directions.

26. The ossicular prosthesis of claim 25, wherein each axis is defined to pass through the geometrical center of its respective distal end within the common plane.

27. The ossicular prosthesis of any one of claims 23-26, wherein one of the limb members comprises a bend of about 102° through a region extending between the proximal and distal ends of the limb member.

28. The ossicular prosthesis of claim 22, wherein at least one of the distal ends comprises a radially expanded region of its respective limb member, the radially expanded region being sized to fittingly insert to the respective fossae at which it is received.

29. The ossicular prosthesis of claim 22, wherein at least one of the distal ends comprises a cylindrical region shaped to fittingly insert to a drilled hole in the stapes footplate.

30. The ossicular prosthesis of claim 20, wherein the hollow is defined by two portions of the proximal region configured to open to receive and then close to enclose a portion of an incudal process.

31. The ossicular prosthesis of claim 30, wherein the two portions defining the hollow are joined through a hinge.

32. The ossicular prosthesis of claim 30, wherein the two portions defining the hollow are fitted to each other by a plurality of pins.

33. The ossicular prosthesis of claim 20, comprising a hinged securing member attached to the proximal region, and moveable to swing into a position extending over the hollow to secure an incudal process to the hollow.

34. The ossicular prosthesis of claim 33, wherein the hinged securing member comprises a bracket secured at bracket ends on two sides of the proximal region, and the bracket is curved between the bracket ends to allow the bracket to swing over and clamp a portion of the incudal process to secure a lenticular process to the hollow.

35. The ossicular prosthesis of claim 19, provided as part of a kit of a plurality of such ossicular prostheses, the kit comprising ossicular prostheses having at least two different corresponding distances extending between the two limb members.

36. The ossicular prosthesis and kit of claim 35, wherein the kit comprises ossicular prostheses having at least two different corresponding heights.

37. The ossicular prosthesis and kit of claim 36, wherein the kit comprises ossicular prostheses having at least five different corresponding distances extending between the two limb members, and at least five different corresponding heights.

38. A method of fitting an ossicular prosthesis to a stapes footplate, the ossicular prosthesis comprising two limb members joined to a proximal region of the ossicular prosthesis at a respective proximal end of each limb member, and the method comprising:

pressing toward each other a respective distal end of each of two limb members;

moving the distal ends into a receiving region of the stapes footplate; and releasing the limb members so that each presses against an inner surface of the receiving region.

39. The method of claim 38, wherein the receiving region is defined between two crurae remnants of the footplate, and each distal end presses against an inner surface of a respective one of the two crurae remnants.

40. The method of claim 38, wherein the receiving region comprises at least one receiving niche cut into the footplate to receive at least one of the distal ends.

41. The method of claim 38, comprising removing a portion of stapes superstructure including at least part of a crurae of the stapes to form a hollow comprising a portion of the receiving region; and wherein the distal end of one of the released limb members occupies a portion of the receiving hollow.

42. The method of claim 41, wherein the removing comprises drilling the stapes footplate.

43. The method of claim 41, wherein the limb members press elastically against the inner surface of the receiving region.

44. An ossicular prosthesis for a human ear, the ossicular prosthesis comprising a contact element sized to fit into a hole drilled into a stapes footplate, a curved limb extending proximally from the contact element, and a securing member at a proximal end of the curved limb;

wherein the curved limb is sized and shaped to extend proximally from the contact element, positioned at a peripheral portion of the footplate, and centrally toward a position over a more central portion of the footplate, where the securing member is positioned to be secured to an incudal process.

45. An ossicular prosthesis for a human ear, the ossicular prosthesis being sized and shaped to extend between an incudal process and at least one peripheral portion of a stapes footplate, for transmitting vibratory movements therebetween.

46. The ossicular prosthesis of claim 45, wherein the peripheral portion comprises a root of a crus remnant.

47. A stapedial prosthesis, configured to interconnect between a direct connection to a lenticular process of an incus and a stapedial footplate.

48. The stapedial prosthesis of claim 47, wherein the direct connection comprises a socket sized for receiving the lenticular process.

49. The stapedial prosthesis of claim 48, wherein the socket is reversibly expandable to receive and retain the lenticular process.

50. The stapedial prosthesis of claim 48, comprising an retaining loop near the socket, sized and positioned to loop over an incudal long process to retain the lenticular process within the socket.