Ossicular prosthesis selectable from a single package

Abstract

An auditory ossicular prosthesis (20) with a first fastening element (21) designed as a head plate for contact with the eardrum, a second fastening element (22) for mechanical connection to a link of the auditory ossicular chain or to the inner ear, and a shaft-shaped connecting element (24) connecting the two fastening elements to one another in a sound-conducting manner along a longitudinal axis, wherein the first fastening element has in its center a through-bore (25) that can be narrowed for fixation and for receiving the connecting element, is characterized in that the connecting element projects through the through-bore onto the side of the first fastening element opposite the second fastening element and carries, at its free end opposite the second fastening element, a third fastening element (23) that is designed for connection to a link of the auditory ossicular chain or to the inner ear,and that the connecting element is designed in its two areas adjacent to the through-hole so that it can be easily separated above or below the first fastening element. This package offers the middle ear surgeon a simple and quick option to select from a range of different prosthesis types immediately before inserting a selected prosthesis into the patient's middle ear.

Description

[0001] The invention relates to an ossicular prosthesis which replaces or bridges at least one link or parts of a link of the ossicular chain, wherein the ossicular prosthesis comprises a first fastening element designed as a flat head plate for mechanical engagement with the eardrum, a second fastening element for mechanical connection to a link or parts of a link of the ossicular chain or to the inner ear, and a shaft-shaped connecting element which connects the two fastening elements to one another in a sound-conducting manner along a longitudinal axis, and wherein the plate-shaped first fastening element has a through-bore in its center for receiving the shaft-shaped connecting element, which is designed to be narrowable for fixing the connecting element.

[0002] Such a device is known from DE 298 19 892 U1 ≈ EP 0 998 884 B1 ≈ US 6,387,128 B1 (=reference [1]). Background of the invention

[0003] Ossicular prostheses are used to transmit sound from the eardrum to the inner ear when the ossicles of the human middle ear are completely or partially missing or damaged. The ossicular prosthesis has two ends. Depending on the specific circumstances, one end of the ossicular prosthesis rests on the eardrum or the handle of the malleus, for example, using a head plate, and the other end of the ossicular prosthesis is attached, for example, to the stapes of the human ossicular chain or immersed directly into the inner ear. In many cases, the known ossicular prostheses only enable sound conduction between the eardrum and the inner ear to a limited extent because they can only replace the natural anatomical formations of the ossicular chain to a very limited extent. (See, for example, DE 42 10 235 C1 or EP 0 809 982 B1 (=reference [2])).

[0004] After the prosthesis has been surgically placed in the middle ear and the eardrum has been closed again, the so-called healing phase begins. During this time, scars form and these cause unpredictable forces that can lead to the prosthesis being displaced from its local position. If the connection between the head plate and the shaft is rigid, increased pressure peaks can occur between the edge of the head plate and the eardrum or the graft between the eardrum and head plate. These peaks can be so high that they could result in penetration or extrusion through the eardrum. For this reason, it is very helpful if the prosthesis has a certain degree of post-operative mobility so that the head plate can adjust itself to the position of the eardrum postoperatively.

[0005] Since the anatomical features of the ear, such as the position, shape, and size of the stapes, incus, malleus, and eardrum, vary, it is highly advantageous if ossicular prostheses are not rigid but exhibit a certain degree of flexibility or variability. To achieve such flexibility / variability, various fastening and coupling devices for ossicles, which comprise elastic parts and / or joints, are known. Such an articulated connection between a fastening element mountable on the stapes footplate and the elongated shaft is described, for example, in EP 1 181 907 B1 (=reference [3]) and is offered by the applicant under the brand name "Ball-Joint."

[0006] Another complication that can occur in various ways is due to insufficient ventilation of the middle ear space and the associated inflammation, tumor formation, adhesions in the eardrum area and stiffening of the same. For example, in the case of dysfunction of the Eustachian tube, negative pressure can develop in the middle ear, which can cause the eardrum to bulge out or protrude (so-called retraction) and subsequently adhere to the stapes, for example. To counteract this and to be able to follow post-operative movements of the eardrum, the head plates in known ossicular prostheses are designed to be tiltable relative to the connecting element that connects the head plate to the second fastening element and is usually designed as an elongated shaft. Such a head plate, which is rigid in itself but can be tilted relative to the connecting element, is described, among other things, in US 2004 / 0162614 A1 (=reference [4]).

[0007] While reference [3] describes an ossicular prosthesis in which the head plate has a built-in ball joint connected to the connecting shaft of the two fastening elements, EP 1 833 424 B1 (=reference [5]) even discloses a connecting shaft designed as a ball chain. This allows the final axial length of the prosthesis to be determined at least in stages by selecting a specific number of balls in the chain and cutting off the excess balls.

[0008] A disadvantage of these known ossicular prostheses, however, is that the rigid tilting of the head plate causes the opposite side of the head plate to move laterally outwards during local medial movements of the eardrum, thereby generating pressure peaks on the eardrum.

[0009] EP 1 972 307 B1 (=reference [6]) discloses an ossicular prosthesis with a highly flexible head plate, which on the one hand retains the advantages of the prosthesis according to the above-mentioned reference [5], but on the other hand also the advantages of the prostheses described in reference [4], while avoiding the common disadvantages of a rigid tilting of the head plate. A problem with the ossicular prosthesis according to reference [6], however, is its insertion into the patient's middle ear, because the head plate protrudes considerably laterally, particularly in the radial direction with respect to its longitudinal axis, and can only be surgically inserted into the middle ear through a large artificial opening through the eardrum area. This large opening is then, of course, more difficult to close again post-operatively and also leaves correspondingly large scars.

[0010] The head plate in reference [6] includes flexible web elements that extend within the head plate plane and connect a radially outer ring region of the head plate with a central coupling region located radially in the center of the head plate. These web elements, together with the radially outer ring region and the central coupling region, are an integral part of the head plate disclosed in reference [6]. They are geometrically designed such that, in the event of local medial movements of the eardrum, they follow such medial movements - also locally - but do not transmit the movement to distant regions of the head plate.

[0011] However, the web elements are not designed to accommodate any radial compression of the head plate within the head plate plane, thus radially reducing the head plate diameter, possibly to facilitate passage through the eardrum. This would be unsuitable for such an application. This is particularly true because the radially outer ring area is rigid and would therefore not accommodate any attempt at such radial compression or, at most, would bend uncontrollably.

[0012] The ossicular prosthesis described in reference [6] is also completely unsuitable for length changes along the z-axis, since the connecting element, which runs along the z-axis and rigidly connects the head plate to the second fastening element, is sound-transmitting but rigid as such. Flexibility of the length of the connecting element in the z-direction is impossible with the ossicular prosthesis according to reference [6] and is not even desired.

[0013] EP 3 311 773 B1 (=reference [7]), on the other hand, describes an ossicular prosthesis with an umbrella-like foldable head plate, by means of which the prosthesis can be surgically inserted into the middle ear in an almost minimally invasive manner through a small opening in the eardrum.

[0014] Another important issue in the implantation of ossicular prostheses is the adjustment of the correct axial length of the prosthesis, which is optimally adapted to the individual conditions and geometric conditions in the patient's middle ear.

[0015] The reference [5] discussed above already proposes a ball chain with detachable end balls. Unfortunately, this does not allow for continuous, but only stepwise, length adjustment.

[0016] A length-variable auditory ossicular prosthesis with a sliding mechanism built into the connecting element between the first and the second fastening element for stepless length adjustment is described in DE 10 2007 041 539 B4 (=reference [8]).

[0017] Instead of such a displacement mechanism, which is relatively complex to manufacture, EP 2 238 946 B1 (=reference [9]) proposes a length-variable ossicular prosthesis in which an accordion-like structure is incorporated into the connecting element. The axial length of the ossicular prosthesis can then be shortened by axial compression of this structure and increased by pulling it apart.

[0018] In EP 2 601 909 B1 (=reference

[10] ), in turn, a sliding mechanism is provided in the connecting element for the axial length adjustment of the auditory ossicular prosthesis, which comprises a receiving part and an insertion part which surrounds the receiving part with two legs in a clamp-like manner, wherein the receiving part and the insertion part are movable relative to one another in the axial direction of the connecting element.

[0019] A laser-activated, length-variable auditory ossicular prosthesis is disclosed in EP 3 130 315 B1 (=reference

[11] ). It proposes constructing the connecting element with stretchable and / or compressible, loop-like folded strands made of a material with shape memory. Activation surfaces are thermally connected to the loops of these strands, which can cause thermal activation and thus deformation of the loops through the application of heat. In this way, the axial length of the auditory ossicular prosthesis can be changed and adjusted as desired.

[0020] EP 1 961 400 B1 (=reference

[12] ) describes a partial ossicular prosthesis, at one end of which a loop is provided, by means of which a region of a link of the ossicular chain can be gripped in a force-fitting manner. The loop is designed such that, when the prosthesis is implanted, it rests firmly against this link, but only in partial areas, in order to avoid complete strangulation of the coupling point on the ossicle. Furthermore, reference

[12] proposes producing at least one of the fastening elements from a material with shape memory (=memory effect) or superelastic properties, preferably from nitinol.

[0021] DE 10 2022 119 451 B3 (=reference

[13] ) presents an ossicular prosthesis with in-situ elongation. The prosthesis consists of two parts: a head plate on the one hand and a connecting element with a second fastening element on the other. The head plate has clamp-like arms by means of which it can be coupled to grooves that run azimuthally around the connecting element. This allows for the length of the ossicular prosthesis to be adjusted even after implantation.

[0022] From DE 10 2009 006 047 B3 (=reference

[14] ) a passive ossicular prosthesis with an applicator is known, which is characterized in that an elongated applicator is provided for transporting the ossicular prosthesis from a sterile packaging to the surgical field and inserting it into the middle ear or the auditory canal, which applicator has, on the one hand, a free end projecting away from the ossicular prosthesis for handling and, on the other hand, an engagement part which is initially fastened to the ossicular prosthesis in a force-fitting manner, a form-fitting manner or via a breakable or shearable material bridge, and which, after the ossicular prosthesis has been inserted into the middle ear or the auditory canal, can be separated from the ossicular prosthesis and removed from the middle ear or the auditory canal together with the applicator.This allows for the simple and cost-effective preparation of a unit consisting of an ossicular prosthesis and a customized transport device optimally adapted to its geometry, which can be removed from the sterile packaging ready for surgery. The applicator can be easily removed from the middle ear and disposed of after implantation of the prosthesis, which greatly simplifies the practical handling of the ossicular prosthesis according to the invention for the surgeon. The entire procedure is standardized, and apart from the surgical microscope, no further aids are required, especially no sterile pretreatment.

[0023] DE 10 2020 108 887 A1 (=reference

[15] ) describes a length-adjustable auditory ossicular prosthesis with a tympanic membrane head plate designed as an elliptical ring with a locking element, which can firmly lock the head plate to the connecting element at different axial positions of the shaft-shaped connecting element.

[0024] Finally, US 2020 / 0113675 A1 (=reference

[16] ) shows a middle ear prosthesis with a tympanic membrane head plate coated with biocompatible silicone, in which the coating is integrated into the head plate in such a way that it at least partially touches the tympanic membrane when the prosthesis is implanted.

[0025] The publications of the sister patents to the above-cited reference [1], on the other hand, disclose a generic ossicular prosthesis with all the features defined above. In particular, they propose providing strip-like bridge elements in the connecting element of the generic ossicular prosthesis, which can be spread radially outward from the longitudinal axis, thereby shortening the axial length of the connecting element and thus the axial length of the ossicular prosthesis. The bridge elements are spread from the side, i.e., in the radial direction relative to the connecting element. Object of the invention

[0026] The object of the present invention, in contrast, is to improve a generic ossicular prosthesis of the type defined above using the simplest possible technical means to the effect that it provides the middle ear surgeon with a simple and quick option to select from a range of different types of ossicular prostheses immediately before inserting the prosthesis specifically selected by the surgeon into the patient's middle ear. Such a selection option is not provided for or even hinted at in any of the references [1] to

[13] discussed above. Brief description of the invention

[0027] According to the invention, this object is achieved in a manner that is as surprisingly simple as it is effective in that the shaft-shaped connecting element projects through the through-bore onto the side of the first fastening element opposite the second fastening element, in that the connecting element carries a third fastening element at its free end opposite the second fastening element, which is designed for mechanical connection to a link or parts of a link of the ossicular chain or to the inner ear, and in that the shaft-shaped connecting element is designed, at least in its two regions adjacent to the through-bore of the first fastening element on both sides, in such a way that it can be broken off above or below the plate-shaped first fastening element or can be separated by means of a separation tool.

[0028] This allows the advantages of the generic ossicular prosthesis described above, as described in reference [1], to be used in a relatively simple manner, whereby the middle ear surgeon now has the option, without any further preparation, to select one of the two different configurations of the ossicular prosthesis offered with the container according to the invention directly during the operation - in particular after inspecting the specific individual situation in the patient's middle ear shortly before inserting the prosthesis - in order to provide the patient with optimal care.

[0029] The surgeon can easily separate the non-selected, i.e. discarded, part of the bundle at the shaft section extended through the head plate (first fastening element) with the unwanted third fastening element attached to it above the head plate, for example by simply breaking it off or using a separation tool.

[0030] This leaves the ossicular prosthesis with the configuration of head plate, connecting element and the desired second fastening element attached to it as a complete and immediately usable ossicular prosthesis and is immediately available for implantation without further adjustments.

[0031] If the container according to the invention contains a third fastening element that is functionally different from the second fastening element, the surgeon can select the optimal second fastening element for the actual situation found in the patient's middle ear without any time delay and can implant it immediately after removing the third fastening element.

[0032] However, if the package according to the invention contains (in addition to the always present head plate) two functionally similar fastening elements, but the shaft length between the head plate and the second fastening element is different from the shaft length between the head plate and the third fastening element, the surgeon can easily adjust the desired prosthesis length by making the appropriate selection.

[0033] In any case, the present invention provides the attending physician with significantly greater flexibility in middle ear surgery.

[0034] In addition, the need to simultaneously store many different middle ear prostheses is significantly reduced. Preferred embodiments of the invention

[0035] The container according to the invention with a shaft-shaped connecting element and a flat head plate for mechanical attachment to the eardrum as central components as well as a second fastening element at one end of the shaft and a third fastening element at the opposite end of the shaft basically does not require any further “ingredients”.

[0036] However, in order to facilitate the separation of the non-selected part of the container by breaking it off, a particularly preferred class of embodiments of the auditory ossicle prosthesis according to the invention is characterized in that the shaft-shaped connecting element has a predetermined breaking point in each of its two regions adjacent to the through-bore of the first fastening element on both sides.

[0037] In a preferred development of this class of embodiments, the predetermined breaking point comprises a ring-shaped, azimuthally circumferential material recess around the shaft-shaped connecting element. Such a predetermined breaking point can be created, for example, by turning or milling the ring-shaped material recess and does not require any specific selection of the bending direction when bending the unwanted part of the prosthesis. Rather, the bending can occur in any radial direction relative to the shaft axis.

[0038] Alternatively, another refinement provides for a notch- or wedge-shaped, one-sided radial material recess in the shaft-shaped connecting element to serve as a predetermined breaking point above and below the shaft-shaped connecting element. Such a notch or wedge can be manufactured on the side of the shaft with extremely simple and inexpensive engineering, but then it defines a preferred radial direction when bending.

[0039] A first group of embodiments of the container according to the invention is characterized in that the first fastening element, together with the second fastening element and a first part of the shaft-shaped connecting element located therebetween, forms a total prosthesis, while the first fastening element, together with the third fastening element and a second part of the shaft-shaped connecting element located therebetween, forms a partial prosthesis. An advantage of this configuration is that the middle ear surgeon only has to make a final decision immediately before inserting the final middle ear prosthesis as to whether, given the actual situation in the patient's middle ear, a total prosthesis is required that bridges all parts of the auditory ossicles, or whether sufficient substance is still present in one or more auditory ossicles to insert a partial prosthesis.

[0040] In a second group of embodiments of the invention, the first fastening element together with the second fastening element and with a first part of the shaft-shaped connecting element located therebetween forms a partial prosthesis, while the first fastening element together with the third fastening element and with a second part of the shaft-shaped connecting element located therebetween also forms a partial prosthesis.

[0041] Thus, when using this bundle, it is already decided that the ossicular prosthesis to be implanted will be a partial prosthesis. However, the treating surgeon can still select the type of second fixation element at short notice.

[0042] If it has already been established - for example through preliminary examinations of the patient - that the auditory ossicles are already so damaged that a partial prosthesis is no longer an option, but a total prosthesis must be used, the treating surgeon can still select the type of the selected second fastening element in a third group of embodiments of the container according to the invention: Here, the first fastening element together with the second fastening element and with a first part of the shaft-shaped connecting element located therebetween forms a total prosthesis, and the first fastening element together with the third fastening element and with a second part of the shaft-shaped connecting element located therebetween also forms a total prosthesis.

[0043] Further developments of the second and third group of embodiments described above are advantageous, which are characterized in that the first part of the shaft-shaped connecting element between the first fastening element and the second fastening element has a different axial length than the second part of the shaft-shaped connecting element between the first and the third fastening element.

[0044] In this way, once it has been determined whether a partial or total prosthesis is to be used, the treating surgeon can easily pre-select the approximate length.

[0045] The practical suitability of these developments can be further improved by the first part of the shaft-shaped connecting element having an axial length between 1.75 mm and 3.5 mm, preferably 2 mm, and the second part of the shaft-shaped connecting element having an axial length between 3 mm and 7 mm, preferably 4 mm.

[0046] In practice, embodiments of the auditory ossicle prosthesis according to the invention have also proven successful, in which the shaft-shaped connecting element has a radial thickness transverse to the longitudinal axis between 0.1 mm and 0.2 mm, preferably 0.18 mm.

[0047] By selecting the exact type of second (or third) fixation element desired, the treating surgeon determines the optimal design of the ossicular prosthesis used for the respective patient.

[0048] For example, embodiments of the container according to the invention are characterized in that the second fastening element and / or the third fastening element is designed as a slotted bell.

[0049] Further advantageous embodiments of the invention are characterized in that the second fastening element and / or the third fastening element is designed as a clip.

[0050] Embodiments of the container according to the invention in which the second fastening element and / or the third fastening element is stamp-shaped can also be advantageous.

[0051] Embodiments in which the second fastening element and / or the third fastening element is designed as a piston are also possible and may be preferred.

[0052] The special effects and advantages of these four variants mentioned above are explained in more detail in the detailed description below.

[0053] In summary, in embodiments of the invention, the second fastening element can be designed as a plate, in particular as a curved plate, as a sleeve, as a loop, as a closed bell, in particular in the form of a hollow cylinder, as a single- or multiply-slit bell, or as a clip for mechanical connection to another link of the ossicular chain. Alternative embodiments can provide for the ossicular prosthesis to be directly coupled to the inner ear at its end bearing the second fastening element by perforating the stapes footplate (=stapedectomy or stapedotomy) and / or by opening the human cochlea (=cochleotomy), in particular via a piston.

[0054] In addition to postoperative displacement, another problem arises after the implantation of ossicular prostheses: the middle ear of the human body represents a "semi-open bed." Any implantable material introduced into the body as part of a reconstruction of the middle ear and its structures is subjected to particular stress due to the contaminated and infected environment that prevails, which typically attacks the material. Since the goal of implanting an ossicular prosthesis must always be to ensure the implant remains in the patient's middle ear as long and as free from complications as possible, prolonged material attack can lead to damage to the prosthesis and / or local infection. Both consequences are unacceptable.To permanently prevent damage to both the implantation material and the surrounding tissue, in a further particularly preferred embodiment of the invention, the surface of the ossicular prosthesis is coated entirely or at least partially with a biologically active coating, in particular a growth-inhibiting and / or growth-promoting and / or antibacterial coating. The head plate of the ossicular prosthesis according to the invention should generally have a growth-promoting coating, whereas a second fastening element leading directly into the inner ear, for example in the form of a piston, should have a growth-inhibiting coating.

[0055] The use of biocompatible materials such as gold or titanium, which are often used in ossicular prostheses, reduces the risk of postoperative infections and rejection reactions.

[0056] Alternatively or additionally, in further embodiments, parts of the ossicular prosthesis according to the invention can be made of a ceramic material. However, embodiments of the invention are also possible in which the prosthesis or parts thereof are made of biocompatible plastics, in particular silicone, polytetrafluoroethylene (PTFE), or fiber composite materials. These materials can also prevent postoperative rejection reactions in most cases.

[0057] The scope of the present invention also includes a system comprising an auditory ossicular prosthesis constructed according to the invention of the type described above and a separation tool for severing the shaft-shaped connecting element.

[0058] The separation tool can be designed as a cutting forceps to create a defined point at the separation point. Using this tool, the surgeon removes the protruding prosthetic shaft with the unselected third attachment element on the lateral side of the tympanic membrane head plate. This creates a spike or pin that, once the ossicular prosthesis is in place, secures the graft material, such as cartilage or fascia, placed between the implant and the tympanic membrane during surgery.

[0059] The separation tool can serve as an implantation aid, particularly for adjusting the length of the selected ossicular prosthesis. It can be designed as a minimally invasive, particularly endoscopic, instrument, preferably in the form of forceps or pliers. Detailed description of the invention based on the drawing

[0060] The schematic drawing shows embodiments of the invention, which are explained in more detail in the following description.

[0061] They show: Fig. 1a a schematic side view of a first embodiment of the container according to the invention comprising a shaft-shaped connecting element projecting through the first fastening element designed as a drumhead head plate, with a second fastening element designed as a slotted bell at one end and a third fastening element designed as a stamp at its other end, wherein the first part of the shaft between the bell and the head plate is axially the same length as the second part of the shaft between the stamp and the head plate; Fig. 1b a spatial representation of the embodiment according to Fig. 1a, wherein the first part of the shaft between the bell and the head plate is axially significantly shorter than the second part of the shaft between the punch and the head plate; Fig. 1c a spatial representation of the embodiment according to Fig. 1a, where the first part of the shaft between the bell and the head plate is axially significantly longer than the second part of the shaft between the punch and the head plate; Fig. 2a a schematic side view of a further embodiment of the container designed according to the invention with a second fastening element designed as a slotted bell at one end of the shaft-shaped connecting element and a third fastening element designed as a clip at its other end, wherein the two shaft parts between the bell and the head plate and between the head plate and the clip are axially of equal length; Fig. 2b a spatial representation of the embodiment according to Fig. 2a, wherein the first part of the shaft between the bell and the head plate is axially significantly shorter than the second part of the shaft between the clip and the head plate; Fig. 2c a spatial representation of the embodiment according to Fig. 2a, wherein the first part of the shaft between the bell and the head plate is axially significantly longer than the second part of the shaft between the clip and the head plate; Fig. 3 shows an embodiment of a container designed according to the invention, in which both the second and the third fastening element are each designed as a slotted bell, the two parts of the shaft between the head plate and the two bells being of different lengths; Fig. 4 shows an embodiment of a container designed according to the invention, in which both the second and the third fastening element are designed as clips, the two parts of the shaft between the head plate and the two clips being of different lengths; Fig. 5 shows an embodiment of a container designed according to the invention, in which both the second and the third fastening element are each designed as a stamp, the two parts of the shaft between the head plate and the two stamps being of different lengths; Fig. 6 shows an embodiment of a container designed according to the invention, in which both the second and the third fastening element are each designed as a piston, wherein the two parts of the shaft between the head plate and the two pistons are of different lengths and the two pistons have different radial diameters; Fig. 7a an embodiment of the container designed according to the invention similar to that in Fig. 2a, but with a ring-shaped material recess encircling the shaft above and below the head plate in an azimuthal manner as predetermined breaking points; Fig. 7b an embodiment similar to Fig. 7a, but with a notch- or wedge-shaped, one-sided radial material recess in the shaft above and below the head plate as predetermined breaking points; Fig. 8 a spatial detailed view of the first fastening element designed as a head plate with a continuous shaft-shaped connecting element above and below the head plate; Fig. 9 a schematic side view of an embodiment of the container according to the invention after separation of the non-selected container part and formation of a spike-shaped tip on the shaft in the region of the side of the head plate opposite the selected part (here with a stamp-shaped fastening element); and Fig. 10 a schematic side view of a separation tool shaped as cutting pliers for severing the shaft-shaped connecting element and for forming a geometrically defined tip at the separation point between the selected part of the container and the non-selected container part.

[0062] The embodiments of the ossicular prosthesis 10; 20; 30; 40; 50; 60 (or parts thereof) according to the invention schematically illustrated in the figures of the drawing each have a first fastening element 11; 21; 31; 41; 51; 61, which is designed in the form of a flat head plate for mechanical engagement with the eardrum. At one end of the ossicular prosthesis 10; 20; 30; 40; 50; 60 there is a second fastening element 12; 22; 32; 42; 52; 62 for mechanically connecting the prosthesis to a member or parts of a member of the ossicular chain or to the inner ear.In between, a shaft-shaped connecting element 14; 24; 34; 44; 54; 64 is arranged which connects the two fastening elements 11, 12; 21, 22; 31, 32; 41, 42 to one another in a sound-conducting manner along a longitudinal axis z, wherein the plate-shaped first fastening element 11; 21; 31; 41; 51; 61 has in its center a through-bore 15; 25 for receiving the shaft-shaped connecting element 14; 24; 34; 44; 54; 64, which is designed to be narrowable for fixing the connecting element 14; 24; 34; 44; 54; 64.

[0063] The invention is distinguished from known ossicular prostheses of the same type in that the shaft-shaped connecting element 14; 24; 34; 44; 54; 64 projects through the through-bore 15; 25; 35; 45 onto the side of the first fastening element 11; 21; 31; 41; 51; 61 opposite the second fastening element 12; 22; 32; 42; 52; 62, that the connecting element 14; 24; 34; 44; 54; 64 has a third fastening element 13; 23; 33; 43; 53; 63, which is designed for mechanical connection to a link or parts of a link of the ossicular chain or to the inner ear, and that the shaft-shaped connecting element 14; 24; 34; 44; 54; 64 is connected at least in its two parts to the through-bore 15; 25; 35; 45 of the first fastening element 11; 21; 31; 41; 51;61 is designed in such a way that it can be broken off above or below the plate-shaped first fastening element 11; 21; 31; 41; 51; 61 or separated by a separation tool 16.;

[0064] This inventive bundle allows the treating surgeon to decide on the design of the ossicular prosthesis immediately before the actual implantation. The non-selected portion of the bundle is then simply removed. The axial length of the ossicular prosthesis selected by the surgeon can be adjusted, for example, by sliding the first fastening element 11; 21; 31; 41; 51; 61, designed as a tympanic membrane head plate, along the shaft-shaped connecting element 14; 24; 34; 44; 54; 64 and subsequently attaching or stiffening it to the shaft, for example by means of a crimping process.

[0065] The container according to the invention significantly reduces the necessary inventory of different ossicular prostheses. The present invention offers the otologist a wide variety of options in the field of tympanoplasty.

[0066] In tympanoplasty, there are various options for coupling to the stapes, depending on the type and extent of the surgical procedure and the condition of the middle ear.

[0067] The most common methods are listed and explained below: 1. Ossiculoplasty: ◯ Partial Ossicle Reconstruction Prosthesis (“PORP”): ◯ This procedure creates a prosthetic connection between the eardrum and the head of the stapes. The stapes remains largely intact.

[0068] The use of a PORP in tympanoplasty offers several advantages: (a)Preservation of natural sound transmission: o A PORP enables more effective sound transmission because it uses the remaining intact parts of the auditory ossicles (especially the stapes), thus largely preserving physiological sound conduction. (b)Better adaptation and stability: ◯ PORP can be easily adapted to the anatomical features of the middle ear, resulting in a more stable and secure connection. This reduces the risk of prosthesis dislocation or displacement compared to other reconstruction methods. (c)Protection of the stapes footplate: o Using a PORP often places less stress or manipulation on the stapes footplate, minimizing the risk of complications such as footplate dislocation or fractures. (d)Improved hearing results: ◯ Studies have shown that patients with PORP tend to have better postoperative hearing improvements, especially in the mid and high frequency range, compared to other methods such as TORP. (e)Versatility in application: o A PORP can be used in a variety of clinical situations, e.g. chronic middle ear infections where the stapes is intact. (f) Lower risk of infection: ◯ The use of biocompatible materials such as titanium, which are often used in PORP prostheses, reduces the risk of postoperative infections and rejection reactions.

[0069] Overall, PORP offers an effective and reliable method for restoring sound conduction in the middle ear while preserving the natural structures and functions of the ear as much as possible. 2. Total Ossicle Reconstruction Prosthesis (“TORP”): When the incus and malleus are completely missing, a prosthesis is used that creates a direct connection between the tympanic membrane and the footplate of the stapes.

[0070] The use of total ossicular reconstruction (TORP) in tympanoplasty offers several specific advantages: (a)Restoration of sound transmission in severely damaged ossicular chains: ◯ TORP is particularly useful in cases where the anvil and malleus have been extensively destroyed or removed. This method allows for the restoration of sound transmission even in severely compromised middle ear structures. (b)Direct connection between the eardrum and the stapes footplate: o A TORP creates a direct connection between the eardrum and the stapes footplate, allowing for efficient sound transmission. This can be particularly beneficial when the remaining portions of the ossicles are no longer usable. (c)Adaptation to individual anatomical conditions: ◯ TORP prostheses can be adjusted in length and shape to accommodate the patient's specific anatomical features. This improves the fit and stability of the prosthesis. (d)Reduced risk of ossicular prosthesis displacement: ◯ The direct and stable connection between the eardrum and the stapes footplate reduces the risk of the prosthesis shifting or loosening, leading to better hearing function in the long term. (e)Bypassing damaged or non-functioning ossicles: ◯ In cases of significant damage or dysfunction of the natural ossicular chain, a TORP can bypass the damaged structures and still ensure effective sound transmission.

[0071] A particularly advantageous variant of the TORP features an oval plunger for a larger contact surface. The applicant's "Regensburg" type total prosthesis, made of titanium, features a large contact area with the stapes footplate thanks to its oval and enlarged plunger end. Combined with a lower center of gravity, this ensures maximum balance and thus facilitates intraoperative handling.

[0072] Other advantageous features of this TORP include small recesses in the head plate that indicate the position of the punch. Below the head plate, the shaft has a diameter of only 0.2 mm. This allows it to be easily bent and shaped to the desired final shape.

[0073] In summary, TORP offers an effective solution for restoring sound conduction in the middle ear, especially in cases where the natural ossicular chain is severely compromised. The ability to create a stable and direct connection between the eardrum and the stapes footplate often leads to good audiological outcomes and improved quality of life for patients. 3. Stapes footplate coupling: ◯ Stapes prosthesis: This method is used in stapedotomy or stapedectomy, often in the treatment of otosclerosis. A prosthesis is anchored to the stapes footplate, either by insertion into a small opening (stapedotomy) or after removal of the stapes footplate (stapedectomy).

[0074] The use of a stapes prosthesis offers several advantages, particularly in the treatment of otosclerosis and other conditions that impede stapes movement. Here are some of the key benefits: (a)Improved hearing performance: ◯ A stapes prosthesis can significantly improve sound transmission by bypassing the stiffness or fixation of the stapes and thus restoring the mechanical movement of sound waves from the middle ear to the cochlea. (b)Minimal invasiveness: ◯ Modern techniques, such as stapedotomy, in which only a small hole is drilled into the footplate of the stapes, are minimally invasive and result in shorter recovery times and less postoperative discomfort compared to more extensive procedures. (c) High success rate: ◯ Success rates for stapes prostheses are high, with a significant number of patients reporting significant improvement in their hearing. Long-term results often show stable hearing improvement. (d)Adaptability: ◯ Stapes prostheses are available in different sizes and materials, such as titanium or Teflon, which allows adaptation to the specific anatomical needs of the patient and ensures an optimal fit. (e)Lower risk of complications: ◯ The use of modern materials and techniques minimizes the risk of complications such as infection or rejection. Furthermore, the materials used are biocompatible and durable. (f) Restoration of natural sound transmission: ◯ The stapes prosthesis enables near-natural sound transmission, resulting in improved sound quality and speech intelligibility. This is particularly important for patients' quality of life. (g)Treatment of otosclerosis: ◯ In otosclerosis, a disease that leads to ossification of the stapes and thus restricts its movement, the stapes prosthesis is a proven and effective treatment method to restore sound transmission. (h)Long-term solution: ◯ A well-implanted stapes prosthesis can provide a permanent solution and reduce the need for further surgery. Many patients report sustained improvements in their hearing for many years. (i) Improved quality of life: ◯ Restoring hearing often significantly improves patients' quality of life. They can better participate in conversations and avoid social isolation, leading to an overall improved sense of well-being.

[0075] In summary, the stapes prosthesis offers an effective and permanent solution for restoring hearing in patients with stapes fixation or otosclerosis, with a high success rate and low risks.

[0076] In order to offer the treating surgeon the most effective selection of decision options possible, the container according to the invention can be designed in variants with different combinations of features:

[0077] So, as can be seen from the Fig. 1a to 1c - the first fastening element 11 together with the second fastening element 12 and with a first section 14' of the shaft-shaped connecting element 14 located therebetween form a partial prosthesis, while the first fastening element 11 together with the third fastening element 13 and with a second section 14" of the shaft-shaped connecting element 14 located therebetween form a total prosthesis.

[0078] Alternatively, as described in the Fig. 2a to 4 - the first fastening element 21; 31; 41 together with the second fastening element 22; 32; 42 and with a first part 24'; 34'; 44' of the shaft-shaped connecting element 24; 34; 44 located therebetween form a partial prosthesis, while the first fastening element 21; 31; 41 together with the third fastening element 23; 33; 43 and with a second part 24"; 34"; 44' of the shaft-shaped connecting element 24; 34; 44 located therebetween also forms a partial prosthesis.

[0079] Another variant shows Fig. 5: It consists in that the first fastening element 51 together with the second fastening element 52 and with a first part 54' of the shaft-shaped connecting element 54 located therebetween forms a total prosthesis, and that the first fastening element 51 together with the third fastening element 53 and with a second part 54" of the shaft-shaped connecting element 54 located therebetween also forms a total prosthesis.

[0080] In the last two variants of the invention, as in the Fig. 1b, 1c, 2b, 2c and 3 to 6 - it can be advantageous if the first part 14'; 24'; 34'; 44'; 54'; 64' of the shaft-shaped connecting element 14; 24; 34; 44; 54; 64 between the first fastening element 11; 21; 31; 41; 51; 61 and the second fastening element 12; 22; 32; 42; 52; 62 has a different axial length than the second part 14"; 24"; 34"; 44"; 54"; 64" of the shaft-shaped connecting element 14; 24; 34; 44; 54; 64 between the first fastening element 11; 21; 31; 41; 51; 61 and the third fastening element 13; 23; 33; 43; 53; 63.

[0081] The specific design of the respective second fastening element 12; 22; 32; 42; 52; 62 and the third fastening element 13; 23; 33; 43; 53; 63 in the container according to the invention also opens up a wide variety of possible variations: The second fastening element 12; 22; 32 and / or the third fastening element 33 may be designed as a slotted bell, as shown in the Fig. 1a to 3 as well as 7a and 7b. The Fig. 2a-c and Fig. 4 each show variants in which the second fastening element 42 and / or the third fastening element 23; 43 can be designed as a clip. The second fastening element 52 and / or the third fastening element 13; 53 can also be stamp-shaped, as the Fig. 1a-c, Fig. 5 and Fig. Show 9. In the embodiment of Fig. 6, the second fastening element 62 and also the third fastening element 63 are even designed as a piston for connection to the inner ear.

[0082] As already explained above, the shaft-shaped connecting element 14; 24; 34; 44; 54; 64 must be designed, at least in its two areas adjacent to the through-bore 15; 25; 35; 45 of the first fastening element 11; 21; 31; 41; 51; 61 on both sides, in such a way that it can be easily broken off above or below the plate-shaped first fastening element 11; 21; 31; 41; 51; 61 or separated by means of a separation tool 16.

[0083] A very simple design option to ensure this function can be to keep the radial thickness of the shaft-shaped connecting element 14; 24; 34; 44; 54; 64 sufficiently small. In this variant, the final length adjustment of the auditory ossicular prosthesis selected by the surgeon can then be achieved by simply sliding the first fastening element 11; 21; 31; 41; 51; 61 axially along the shaft-shaped connecting element 14; 24; 34; 44; 54; 64 and subsequently crimping the head plate firmly into the desired shaft position.

[0084] A further break-off aid can consist in the shaft-shaped connecting element 14; 24; 34; 44; 54; 64 having a predetermined breaking point 17'; 17" in each of its two areas adjacent to the through-bore 15; 25; 35; 45 of the first fastening element 11; 21; 31; 41; 51; 61 on both sides.

[0085] Such a predetermined breaking point 17' can comprise a ring-shaped azimuthally circumferential material recess around the shaft-shaped connecting element 14; 24; 34; 44; 54; 64, as in Fig. 7a is shown schematically. The predetermined breaking point 17" can also be designed as a notch- or wedge-shaped, one-sided radial material recess in the shaft-shaped connecting element 14; 24; 34; 44; 54; 64, in Fig. 7b illustrated.

[0086] After the surgeon removes the non-selected portion of the inventive bundle immediately prior to the actual implantation of the desired ossicular prosthesis, the selected portion initially has a broken or cut end at the shaft end of the connecting element above the tympanic membrane head plate, which can be either reworked (e.g., removed or smoothed) before the prosthesis is inserted into the patient's middle ear. Alternatively, this end can also be deliberately left in its current shape, especially if a special tool was used to remove the non-selected portion: Spike and cartilage disc

[0087] After adjusting the length of the prosthesis prior to implantation, it typically has a maximum length of 0.1 mm. When removing the non-selected portion of the inventive bundle (if necessary using a special tool; see below), the broken or cut end can be deliberately shaped into a pointed "spike." This spike, projecting beyond the tympanic membrane head plate toward the tympanic membrane, can then be used to fix a cartilage disc to the head plate (prosthesis head).

[0088] When using prostheses such as the PORP or TORP described above, a cartilage disc, which is surgically removed from the patient's body, can be inserted between the head plate of the prosthesis and the eardrum. This cartilage disc has several important functions and advantages: (a)Stability and positioning: ◯ The cartilage disc helps keep the prosthesis stable and secure its position. This reduces the risk of displacement or loosening of the prosthesis, resulting in better and more consistent sound transmission. (b)Avoidance of eardrum perforation: ◯ By inserting the cartilage disc, direct contact between the hard head plate of the prosthesis and the delicate eardrum is avoided. This reduces the risk of eardrum perforation or damage that could occur due to mechanical pressure or movement of the prosthesis. (c) Damping and vibration optimization: ◯ The cartilage disc acts as a damping element, optimizing vibrations between the prosthesis and the eardrum. This contributes to improved sound quality and helps prevent unpleasant noises or distortion. (d)Biocompatibility and tissue compatibility: Cartilage is a biocompatible material that integrates well with the tissue of the middle ear. This promotes healing and reduces the risk of inflammation or rejection compared to artificial materials. (e)Avoidance of scarring and adhesions: ◯ The cartilage disc can help prevent the formation of scar tissue and adhesions that could impair the mobility of the prosthesis and sound transmission. (f) Flexibility and adaptation to individual anatomy: ◯ Cartilage can be customized in size and shape to ensure optimal fit and function in the middle ear. This is especially important in complex anatomical situations or in cases of previous surgery. (g)Long-term shelf life: Cartilage is a robust material that remains stable over time and is not as easily degenerated or broken down as other tissue types. This contributes to the long-term functionality of the reconstructed ossicular chain.

[0089] In summary, the cartilage disc serves as a multifunctional element in both PORP and TORP, ensuring prosthetic stability, protecting the eardrum, optimizing vibration transmission, and promoting biocompatibility. The spike then ensures optimal mechanical coupling of the ossicular prosthesis to the cartilage disc. All of these factors contribute to better surgical and audiological outcomes. Special tools

[0090] The use of specially developed cutting forceps can also be extremely useful for the professional further processing of the ossicular prosthesis that will ultimately be implanted in the middle ear. With this tool, the surgeon removes the protruding prosthetic shaft on the lateral side of the head plate. This creates a pin or spike that, once the prosthesis is in place, secures the graft material, such as cartilage or fascia, that is inserted between the implant and the eardrum.

[0091] The present invention therefore also describes a system comprising an auditory ossicle prosthesis 10; 20; 30; 40; 50; 60 of the type described above and a - as in Fig.10 shows a separation tool 16 for severing the shaft-shaped connecting element 14; 24; 34; 44; 54; 64. This separation tool 16 can be designed as a cutting pliers for forming a geometrically defined tip at the separation point of the connecting element 14; 24; 34; 44; 54; 64, but also in the manner of tweezers. List of reference symbols: 10; 20; 30; 40; 50; 60 auditory ossicular prosthesis 11; 21; 31; 41; 51; 61 first fastening element 12; 22; 32; 42; 52; 62 second fastening element 13; 23; 33; 43; 53; 63 third fastening element 14; 24; 34; 44; 54; 64 connecting element 14'; 24'; 34'; 44'; 54'; 64' first section of the connecting element 14"; 24"; 34"; 44"; 54"; 64" second part of the connecting element 15; 25 through hole 16 Separation tool 17'; 17" breaking point z Longitudinal axis Reference list

[0092] Publications considered for the assessment of patentability: 1 DE 298 19 892 U1 ≈ EP 0 998 884 B1 ≈ US 6,387,128 B1 2 DE 42 10 235 C1; EP 0 809 982 B1 3 EP 1 181 907 B1 4 US 2004 / 0162614 A1 5 EP 1 833 424 B1 6 EP 1 972 307 B1 7 EP 3 311 773 B1 8 DE 10 2007 041 539 B4 9 EP 2 238 946 B1 10 EP 2 601 909 B1 11 EP 3 130 315 B1 12 EP 1 961 400 B1 13 DE 10 2022 119 451 B3 14 DE 10 2009 006 047 B3 15 DE 10 2020 108 887 A1 16 US 2020 / 0113675 A1

Claims

[1] An ossicular prosthesis (10; 20; 30; 40; 50; 60) which replaces or bridges at least one link or parts of a link of the ossicular chain, the ossicular prosthesis (10; 20; 30; 40; 50; 60) comprising a first fastening element (11; 21; 31; 41; 51; 61) designed as a flat head plate for mechanical engagement with the eardrum, a second fastening element (12; 22; 32; 42; 52; 62) for mechanical connection to a link or parts of a link of the ossicular chain or to the inner ear, and a longitudinal axis (z) which connects the two fastening elements (11, 12; 21, 22; 31, 32; 41, 42; 51, 52; 61,62) sound-conductively interconnecting, shaft-shaped connecting element (14; 24; 34; 44; 54; 64), wherein the plate-shaped first fastening element (11; 21; 31; 41; 51; 61) has in its center a through-bore (15; 25) for receiving the shaft-shaped connecting element (14; 24; 34; 44; 54;64) which is designed to be narrowable for fixing the connecting element (14; 24; 34; 44; 54; 64); characterized by , that the shaft-shaped connecting element (14; 24; 34; 44; 54; 64) projects through the through-bore (15; 25) onto the side of the first fastening element (11; 21; 31; 41; 51; 61) opposite the second fastening element (12; 22; 32; 42; 52; 62), that the connecting element (14; 24; 34; 44; 54; 64) carries a third fastening element (13; 23; 33; 43; 53; 63) at its free end opposite the second fastening element (12; 22; 32; 42; 52; 62), which is designed for mechanical connection to a link or parts of a link of the ossicular chain or to the inner ear, and that the shaft-shaped connecting element (14; 24; 34; 44; 54; 64), at least in its two areas adjacent to the through-bore (15; 25) of the first fastening element (11; 21; 31; 41; 51; 61) on both sides, is designed such that it is above or below the plate-shaped first fastening element (11; 21; 31; 41; 51; 61) or can be separated by means of a separation tool (16). [2] An auditory ossicle prosthesis according to claim 1, characterized bythat the shaft-shaped connecting element (24) has a predetermined breaking point (17'; 17") in each of its two areas adjacent to the through-bore (25) of the first fastening element (21) on both sides. [3] Ossicular prosthesis according to claim 2, characterized by that the predetermined breaking point (17') comprises a material recess which runs azimuthally around the shaft-shaped connecting element (24) in a ring-shaped manner. [4] Ossicular prosthesis according to claim 2, characterized by that the predetermined breaking point (17") comprises a notch- or wedge-shaped, one-sided radial material recess in the shaft-shaped connecting element (24). [5] Ossicular prosthesis according to one of claims 1 to 4, characterized bythat the first fastening element (11) together with the second fastening element (12) and with a first part (14') of the shaft-shaped connecting element (14) located therebetween forms a partial prosthesis, and that the first fastening element (11) together with the third fastening element (13) and with a second part (14") of the shaft-shaped connecting element (14) located therebetween forms a total prosthesis. [6] An auditory ossicle prosthesis according to any one of claims 1 to 4, characterized bythat the first fastening element (21; 31; 41) together with the second fastening element (22; 32; 42) and with a first part (24'; 34'; 44') of the shaft-shaped connecting element (24; 34; 44) located therebetween forms a partial prosthesis, and that the first fastening element (21; 31; 41) together with the third fastening element (23; 33; 43) and with a second part (24"; 34"; 44") of the shaft-shaped connecting element (24; 34; 44) located therebetween also forms a partial prosthesis. [7] An auditory ossicle prosthesis according to any one of claims 1 to 4, characterized bythat the first fastening element (51) together with the second fastening element (52) and with a first part (54') of the shaft-shaped connecting element (54) located therebetween forms a total prosthesis, and that the first fastening element (51) together with the third fastening element (53) and with a second part (54") of the shaft-shaped connecting element (54) located therebetween also forms a total prosthesis. [8] An auditory ossicle prosthesis according to one of claims 6 or 7, characterized bythat the first part (14'; 24'; 34'; 44'; 54'; 64') of the shaft-shaped connecting element (14; 24; 34; 44; 54; 64) between the first fastening element (11; 21; 31; 41; 51; 61) and the second fastening element (12; 22; 32; 42; 52; 62) has a different axial length than the second part (14", 24"; 34", 44"; 54"; 64") of the shaft-shaped connecting element (14; 24; 34; 44; 54; 64) between the first fastening element (11; 21; 31; 41; 51; 61) and the third fastening element (13; 23; 33; 43; 53; 63). [9] Ossicular prosthesis according to claim 8, characterized by that the first part (14'; 24'; 34'; 44'; 54'; 64') of the shaft-shaped connecting element (14; 24; 34; 44; 54; 64) has an axial length between 1.75 mm and 3.5 mm, preferably 2 mm, and that the second part (14"; 24"; 34"; 44"; 54"; 64") of the shaft-shaped connecting element (14; 24; 34; 44; 54; 64) has an axial length between 3 mm and 7 mm, preferably 4 mm. [10] An auditory ossicle prosthesis according to any one of the preceding claims, characterized by that the shaft-shaped connecting element (14; 24; 34; 44; 54; 64) has a radial thickness transverse to the longitudinal axis (z) between 0.1 mm and 0.2 mm, preferably 0.18 mm. [11] An auditory ossicle prosthesis according to any one of the preceding claims, characterized by that the second fastening element (12; 22; 32) and / or the third fastening element (33) is designed as a slotted bell. [12] An auditory ossicle prosthesis according to any one of the preceding claims, characterized by that the second fastening element (42) and / or the third fastening element (23; 43) is designed as a clip. [13] An auditory ossicle prosthesis according to any one of the preceding claims, characterized by that the second fastening element (52) and / or the third fastening element (13; 53) is stamp-shaped. [14] An auditory ossicle prosthesis according to any one of the preceding claims, characterized by that the second fastening element (62) and / or the third fastening element (63) is designed as a piston. [15] System comprising an auditory ossicle prosthesis (10; 20; 30; 40; 50; 60) according to one of the preceding claims, and a separation tool (16) for severing the shaft-shaped connecting element (14; 24; 34; 44; 54; 64), characterized by that the separation tool (16) is designed as a cutting pliers for forming a geometrically defined tip at the separation point of the connecting element (14; 24; 34; 44; 54; 64), preferably also in the form of tweezers.

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