WO2016155729A1

WO2016155729A1 - Prosthetic heart valve system

Info

Publication number: WO2016155729A1
Application number: PCT/DE2016/200150
Authority: WO
Inventors: Hans-Hinrich Sievers; Michael Scharfschwerdt; Andreas Hof
Original assignee: Hans-Hinrich Sievers
Priority date: 2015-04-02
Filing date: 2016-03-23
Publication date: 2016-10-06
Also published as: DE102015206098A1; DE102015206098B4

Abstract

The invention relates to an implantation aid (16) for a biological prosthetic heart valve (1), having a handle portion (20) which is used to handle the implantation aid and a retaining portion (22) which is used to retain the prosthetic heart valve. The implantation aid is designed such that the retaining portion of the implantation aid is placed on an axial end of the prosthetic heart valve, and the retaining portion has first retaining elements (24), which are designed to fix the commissures (12) of the prosthetic heart valve, and second retaining elements (32), which are designed to come into engagement with prosthetic heart valve regions lying between the commissures and which can be moved in the radial direction relative to a flow direction of the prosthetic heart valve in order to thus reduce the cross-section of the prosthetic heart valve. The invention also relates to a prosthetic heart valve system comprising a heart valve and such an implantation aid.

Description

Title: Heart valve prosthesis system

description

[01] The invention relates to an implantation aid for a biological heart valve prosthesis and to a heart valve prosthesis system comprising such an implantation aid and an associated heart valve prosthesis. [02] From DE 10 2010 051 632 B4 a stented biological heart valve prosthesis is known, which has a flap frame formed from an elastically deformable metallic wire with three flap sails made of biological material arranged thereon. The flap sails are designed as pocket flaps. The flap frame is designed so that it can expand after implantation in the radial direction (relative to the flow direction or flow axis through the heart valve prosthesis). This allows the arches of the valve frame to expand into the sinus aortae. For the sewing of such a heart valve, however, it is necessary to compress the flap frame radially on insertion so as to reduce the cross-section and to ensure accessibility to the sewing ring.

[03] It is an object of the invention to provide a suitable device which simplifies the implantation of a heart valve prosthesis. This object is achieved by an implantation aid having the features specified in claim 1 and by a heart valve prosthesis system with the features specified in claim 13. Preferred embodiments will become apparent from the subclaims, the following description and the accompanying figures.

[05] The implantation aid according to the invention serves to hold a biological heart valve prosthesis during implantation and is separated from the prosthesis after insertion and suturing. The implantation aid according to the invention offers, on the one hand, a grip portion which serves to grip, hold and handle the implantation aid. On the other hand, the implantation aid has a holding section, which serves to hold the heart flap prosthesis to the implantation aid. The grip portion and the holding portion are preferably arranged at opposite ends, in particular at opposite longitudinal ends of the implantation aid. The longitudinal ends are preferably remote from each other in the direction of a longitudinal axis which corresponds to the longitudinal or flow axis of a heart valve prosthesis attached to the holding section. That is, when the heart valve prosthesis is disposed in the intended manner on the holding portion, the longitudinal axis of the implantation aid extends from the holding portion to the handle portion along the flow axis of the heart valve prosthesis. As described, the implantation aid is designed to be attached with its holding section to an axial end of the heart valve prosthesis or to grasp an axial end of the heart valve prosthesis with the holding section. This is preferably the downstream axial end of the heart valve prosthesis. This axial end is that axial end of the heart valve prosthesis which faces away from the attachment region and in particular from a sewing ring of the heart valve prosthesis. Thus, when the heart valve prosthesis is held on the implantation aid, the attachment area and in particular a sewing ring are freely accessible in order to be able to sew the heart valve prosthesis into a blood vessel. The implantation aid is particularly preferred for an aortic valve prosthesis and more preferably a biological aortic valve prosthesis is provided, which has a valve frame to which flap flaps are attached from biological material, as it is known for example from DE 10 2010 051 632 B4. [07] The holding section has two types of holding elements. First holding elements are designed to fix the commissures of the heart valve prosthesis. D. h., The first holding elements are arranged so that the commissures between the pocket flaps can be fixed to the first holding elements. In addition, there are second holding elements which are designed to engage with areas of the heart valve prosthesis located between the commissures. These are preferably the areas on the valve frame which are to be deformed upon insertion in order to reduce the cross-section of the heart valve prosthesis. Particularly preferably, these are located between the commissures arches of the flap frame, where the flap sails are attached with its edge. The second holding elements are designed such that they can engage with these sections of the heart valve prosthesis and hold or fix them. At the same time, the second holding elements are designed such that they can be moved in the radial direction relative to a longitudinal axis of the implantation aid. The second holding elements are preferably movable relative to the first holding elements. The longitudinal axis of the implantation aid corresponds to a flow direction or flow axis of the heart valve prosthesis, when this heart valve prosthesis is attached to the holding section. Thus, by movement in the radial direction, the second holding elements can move the sections of the valve frame of the heart valve prosthesis they grip in the radial direction with respect to the longitudinal or flow axis of the heart valve prosthesis in order to reduce the size of the heart flap prosthesis in such a way that a fastening region and in particular sewing ring of the heart valve prosthesis the implantation is easily accessible. By radial movement in the reverse direction, these areas of the heart valve prosthesis can then be expanded again after suturing and expand in the radial direction, as is known from DE 10 2010 051 632 B4. [08] The second holding elements are preferably movable between a radially outer and a radially inner position, wherein fixing means are provided to releasably fix the second holding elements in their radially inner position. The fixing means may be mechanical fixing elements by means of which the second holding elements can be fixed in their radially inner position, whereby the second holding elements can be released by releasing the fixing elements so that they move radially outwards in the manner described ,

[09] Preferably, there are three first holding elements and three second holding elements. Ie. The implantation aid fits a heart valve prosthesis with three valve leaflets and three commissures in between. The three first holding elements can thus fix the three commissures, while the three second holding elements can engage the parts of the flap frame located between the commissures in order to fix them and compress them in the radial direction as described above.

Preferably, the first holding elements have fastening means for attachment to the commissures of a heart valve prosthesis, wherein the fastening means are preferably formed as holes through which threads are guided for sewing with the commissures or can be performed. The fastening means are designed so that the heart valve prosthesis is held securely to the implantation aid before implantation. Particularly preferably, the implantation aid is designed so that they together with the heart valve as a prefabricated unit is provided to the surgeon. This has the advantage that the surgeon does not have to attach the heart valve himself to the implantation aid and that a very simple handling during the operation is possible, in which the entire heart valve can be held and handled on the implantation aid and in particular its grip section. This protects the heart valve prosthesis from damage during the operation. In order to allow a secure attachment, offers a stitching. In this respect, the fastening means are preferably formed as Lö- rather, are guided by which threads for sewing with the commissures. A heart valve prosthesis so sutured to the first holding elements can be separated from the implantation aid after suturing in the blood vessel by severing the sutures. However, other suitable fasteners may be used to hold the commissures.

[1 1] The second retaining elements preferably comprise engagement means which are adapted to releasably engage a valve frame of a prosthetic heart valve, the engagement means preferably being formed as grooves in a manner to receive the valve frame from its radial outside can embrace her. If the heart valve prosthesis is fixed to the first holding elements, the axial position of the heart valve prosthesis is preferably fixed to the implantation aid, so that in the axial direction preferably also a defined position of the valve frame is predetermined relative to the second holding elements. In this respect, a releasable fixation of the second holding elements on the flap frame is very easily possible, since slipping in the circumferential direction or axial direction is not possible by fixing the heart valve prosthesis to the first holding elements. In this respect, the engagement means on the second holding elements are preferably designed such that they grasp the heart valve prosthesis and in particular its valve frame can that the flap frame or the gripped portions of the flap frame can be moved together with the second holding elements in the radial direction. Ie. The engagement means on the second retaining elements preferably act as a driver, in order to bring about a secure movement of the flap frame by movement of the second retaining elements. For this purpose, an embodiment of the engagement means offers as grooves, wherein the grooves are preferably formed so that their openings are directed radially inwardly, ie, the openings of the grooves of the preferably three second holding elements face each other. At the same time, the grooves preferably extend in a circumferential direction relative to the longitudinal axis of the implantation aid. Thus, they can securely grasp circumferentially extending portions of the valve frame. More preferably, the grooves extend substantially parallel to pivot axes about which the second holding elements are pivotable relative to the remaining parts of the implantation aid, as will be described below.

[12] According to a further preferred embodiment of the invention, the second holding elements are coupled to an actuating element, via which the second holding elements are movable in the radial direction, wherein the actuating element is preferably designed to be rotatable. Particularly preferably, the actuating element is designed such that it moves the plurality of second holding elements, in particular the three second holding elements simultaneously and synchronously. The movement of the plurality of second holding elements via a common actuating element simplifies handling. Particularly preferably, the actuating element is rotatable, for example designed as a rotary wheel. This allows good handling with the certainty that a misoperation is avoided, since a rotational movement of the actuating element can not be easily carried out unintentionally. Particularly preferred is the actuating element rotatable about an axis of rotation which extends in the direction of the longitudinal axis of the implantation aid.

[13] Further preferably, the second holding elements are each pivotably and preferably detachably connected to a carrier element. Thus, the second holding elements can preferably be pivotable about pivot axes, which extend tangentially to the longitudinal axis of the implantation aid. For this purpose, the second holding elements are preferably each pivotably connected at one longitudinal end to a carrier element of the implantation aid, so that they can pivot relative to the carrier element.

[14] The engagement means of the second holding elements, which are adapted to engage the valve frame of a heart valve prosthesis, are preferably arranged in a spaced from the pivotable articulation area, more preferably at a spaced from the articulation axial free end of the second holding element , As a result of the pivoting of the retaining element, the engagement section or the engagement means is thus pivoted onto an arc so that a radial displacement relative to the longitudinal axis of the support element, which corresponds to the longitudinal axis of the implantation aid, occurs. As described above, this longitudinal axis is simultaneously the longitudinal axis or flow axis of a heart valve prosthesis held on the holding section.

[15] More preferably, the retaining elements are releasably hinged to the support member so that they can be completely removed after implantation. In this case, an actuating element is further preferably provided, which moves the holding elements in the manner described and, moreover, is movable into a release position, in which the second holding elements are completely released, so that they can be released from the carrier element. In the remaining positions of the actuating element, the holding elements are preferably held by the actuating element on the carrier element. Particularly preferably, the holding elements in the region of their articulation on the carrier element on peg-shaped projections which act as hinge axes and are pivotally mounted in recesses of the support member. Such a configuration makes it possible to remove the second holding elements in the radial direction from the recesses of the carrier element. The fixation on the carrier element can take place, for example, by a ring surrounding the outer holding elements on the outside, which prevents the radial movement of the second holding elements out of the recesses and can be removed for releasing.

[1 6] According to a further preferred embodiment, the first holding elements are firmly connected to the carrier element and preferably formed integrally therewith. In particular, the carrier element may be made of plastic. The other parts of the implantation aid can preferably be made of plastic or even suitable metals or other suitable materials. [1 7] Also, the handle portion is preferably formed on the support member, more preferably integrally formed therewith. The grip portion may be formed so as to be formed directly for gripping the implantation aid.

[18] According to another preferred embodiment, the grip portion may be formed to have attachment means which enable a handle to be attached to the grip portion. Thus, the handle portion may in particular have a thread on which a handle can be releasably attached or is releasably attached. This has the advantage that a larger, again utilizable handle can be connected to the implantation aid, so that the handling is simplified. The handle is preferably designed to be reusable, while the implantation aid is preferably designed as a disposable article which is not reused and used only once with an associated heart valve prosthesis.

According to a further preferred embodiment, the second holding elements are pivotally articulated in the radial direction on the outer circumference of the support element and the outer circumference surrounded by a relative to the support member axially movable ring or ring body, which rests against the second holding elements such that the second holding elements of the ring body are pressed radially inward. The annular body preferably secures the second holding elements on the carrier element. The annular body preferably has an inner diameter which is smaller than the maximum diameter, which is spanned by the engagement regions or engagement means of the second retaining elements. Thus, it is possible that during the axial displacement of the annular body on the holding elements they are pivoted radially inward, depending on how far a contact point of the annular body is spaced on the holding element of the pivotable articulation of the holding element. Preferably, the annular body has a diameter which substantially corresponds to the diameter of the carrier element in the region of the articulation of the second holding elements, ie the minimum diameter, which is to be clamped by the holding elements in the radially inwardly pivoted position. The ring and the second holding elements are further preferably designed so that when the ring body is completely removed in the axial direction of the second holding elements, they can be as shown gerelement from its articulation on the carrier and be removed so completely from the carrier element can. The linkage is preferred the holding elements on the support member and the annular body designed so that the holding elements can be deflected in a first position so far radially outward that they can reach the parts of the heart valve prosthesis to be taken in their relaxed state. By axial displacement of the annular body then the second holding elements can be pivoted radially inwardly, whereby the gripped portions of the valve frame of the heart valve prosthesis are also moved radially inward and so the cross-section of the heart valve prosthesis is reduced. [20] The annular body is preferably axially movably guided on the carrier element and can be moved axially in at least one direction by an actuating element arranged on the carrier element. This actuating element is preferably rotatable, as described above, so that it can be actuated by turning. For this purpose, the actuating element can further preferably have a thread which is in engagement with a corresponding thread on the carrier element in such a way that the actuating element is moved axially on its rotation in or on the thread on the carrier element, wherein the actuating element preferably completely depends on the thread the support element is removable. Thus, the actuator may be screwed, for example in the manner of a nut on a threaded pin. As a result, it is fixed on the one hand to the support member and can be moved axially to another by rotating movement, thereby preferably, as described above, to move an annular body on the second support members in the axial direction. For this purpose, the annular body preferably rests against the actuating element with an axial end. Alternatively, the annular body could also be formed integrally with the actuating element. However, a two-part embodiment has the advantage that the ring body itself does not have to rotate, but rather can be designed so that it moves only axially. He can do this on the support element in be suitably axially guided to prevent rotation of the ring body. This prevents the ring body from exerting a force on the second holding elements in the circumferential direction, which could lead to an undesired deformation of a grasped heart valve prosthesis. If the actuating element can be completely removed from the thread, it can thereby be made possible that the second holding elements can be detached from the carrier element by removing the actuating element, for example by releasing an annular body on the carrier element and thus also be able to be removed completely from the carrier element. Preferably, the actuating element and the annular body can be removed in an axial direction from the carrier element, which faces away from the holding section on which the heart valve prosthesis is held. [21] In addition to the above-described implantation aid, the subject matter of the invention is a heart valve prosthesis system consisting of a biological heart valve, in particular a biological heart valve, as known from DE 10 2010 051 632 B4, and an implantation aid, as described above. The heart valve prosthesis system is preferably designed so that the heart valve prosthesis attached to the implantation aid is made available to a surgeon, ie delivered as a preassembled unit. This allows safe handling of the heart valve prosthesis before and during the operation, since the heart valve prosthesis can be gripped so preferably exclusively on the implantation aid. The heart valve prosthesis has a flap frame, with which the second holding elements of the implantation aid can engage in such a way that the flap frame is elastically deformed by the radial movement of the second holding elements and reduced in its cross-section. The flap frame is preferably formed of metal, in particular of a shape memory material. By the spring action can expand the valve frame in the described manner in the radial direction and in particular sections of the valve frame can expand into the sinus aortae. As described above, the implantation aid serves to reduce the size of the valve frame for implantation in its cross section in such a way that a sewing ring is easily accessible and sewing is possible. With regard to the mode of operation of the implantation aid, reference is made to the above description, wherein the features described there likewise represent preferred features of the heart valve prosthesis system. The heart valve prosthesis system is preferably designed such that the second holding elements are movable by an actuating element radially inwardly against a restoring force generated by the elastic deformation of the flap frame. In this case, the actuating element is preferably designed such that it moves the second holding elements jointly or simultaneously, in particular in the manner described above. When the actuating element is released in the reverse direction, the retaining elements preferably move radially outwards again due to the elastic restoring forces of the flap frame. [23] More preferably, the heart valve prosthesis at the axial ends of their commissures releasably connected to the first holding elements of the implantation aid and in particular sutured. The sewn connection can be released by cutting through the threads. It is thus given a secure connection between the prosthetic heart valve and the implantation aid, which on the one hand can not be solved unintentionally, on the other hand, however, is still solvable.

[24] The implantation aid according to the invention or the heart valve prosthesis system according to the invention make possible a surgical procedure which is likewise the subject of the invention. In this In surgical procedures, the implantation aid is connected to the heart valve profhesis to a preassembled unit as described above. In this connection, after having grasped portions of the valve frame of the heart valve prosthesis, the second retaining elements are moved radially inwardly such that these sections of the valve frame are also deformed radially inwardly. In this state, the heart valve prosthesis with its sewing ring is sutured to a blood vessel. The heart valve prosthesis is designed in particular as known from DE 10 2010 051 632 B4. After suturing the heart valve prosthesis, the second holding elements are moved radially outwardly, for example by turning an actuating element on a thread, as described above. In this case, the gripped portions of the heart valve prosthesis move back into their radially expanded position due to their elastic restoring forces. Finally, the second holding elements are preferably completely removed and removed, and finally the first holding elements are separated from the heart valve prosthesis, in particular by cutting the threads holding the heart valve prosthesis on the implantation aid. With regard to further details of the method, reference is made to the above description of the implantation aid and the heart valve prosthesis system, from which also the essential method steps result.

1 is a perspective schematic representation of a biological heart valve prosthesis for use with the implantation aid according to the invention, FIG.

2 is an exploded view of an implantation aid according to the invention, 3 shows a side view of the implantation aid according to FIG. 2 in the assembled state, FIG.

4 shows a plan view of the assembled implantation aid in the direction of the arrow in FIG. 3 IV, and FIG. 5 shows a side view of the implantation aid according to FIG. 3 in FIG

Direction of the arrow V in Fig. 3rd

[26] Fig. 1 shows a heart valve prosthesis, as it is known from DE 10 2010 051 632 B4. The heart valve prosthesis consists essentially of a flap position 2 which carries three flap flaps or flap sails 4. In the direction of the flow direction or flow axis S, the heart valve prosthesis has a first downstream axial end 6 and a second upstream axial end 8. At the first axial end 6, the leaflets 4 abut one another in a line and thus form the closed state shown in FIG. To open the flap sails 4 move apart in a known manner.

The flap frame 2 is formed by three arcuate portions 10, which are open in each case to the first axial end 6 and on which the flap sails 4 are fastened with their edges. The arcuate portions 10 are connected to each other in the commissures 12. The connection is made by smaller arcuate portions which are open to the second axial end 8, so that the flap frame 4 is formed as a continuous closed structure. Preferably, the flap frame 2 is made as a bent wire structure of a sufficiently elastic material, in particular a shape memory material. The flap frame 2 may preferably be enveloped, for example by a fabric material. The fabric material or the material of the envelope also covers the commissures 12, ie the areas between the arcuate portions 10 to the second axial end 8 connects to the arcuate portions 10, a sewing ring 14, which is made of a fabric or a fabric material and sewing the heart valve prosthesis in the blood vessel is used , The sewing ring 14 is firmly connected to the flap frame 2 and its enclosure.

[28] The heart valve prosthesis is designed so that the arcuate portions 10 can move radially outward relative to the suture ring 14 and project radially beyond the suture ring 10 so that they extend into the sinus aortae in the implanted state can. This necessitates compressing the flap frame radially inward for implantation, whereby the arcuate sections 10 are elastically deformed and in the area of the arcuate sections 10 the cross section transverse to the flow axis S is reduced in order to ensure accessibility to the sewing ring 14 and to be able to sew in the heart valve prosthesis. For this purpose, the implantation aid described below with reference to FIGS. 2-5 is provided. Together with this implantation aid 16, the heart valve prosthesis 1 shown in FIG. 1 forms a heart valve prosthesis system. For simplified and better visibility of the implantation aid 1 6, not the entire heart valve prosthesis 1, but only the valve frame 2 is shown in FIGS. 2, 3 and 5.

[29] The implantation aid 16 shown has a carrier element 18 as the central component. In the direction of the longitudinal axis X of the implantation aid 16, which in use is aligned with the longitudinal axis or flow axis S of the heart valve prosthesis 1, the implantation aid 16 has a grip portion 20 and a holding portion 22. The handle portion 20 is provided with a thread which serves to screw a handle on the support member 18. About the grip section 20 or a handle connected to the handle portion 20, the implantation aid 1 6 is moved and held. The holding section 22 serves to fix the heart valve prosthesis 1 to the implantation aid 16. For this purpose, the holding section 22 has three first holding elements 24, which are formed integrally with the carrier element 18 and extend, starting from the carrier element 18, to that axial end on which the heart valve prosthesis 1 is held. In this case, the first holding elements 24 are formed such that, starting from the carrier element 18, they not only extend away in the axial direction X, but at the same time extend obliquely outward, so that they essentially form a frusto-conical shape. At their ends facing away from the carrier element 18, the first holding elements 24 are connected to one another via webs 26, which give the structure greater stability. Furthermore, in the first holding elements 24 at their free ends remote from the carrier element 18, respective holes 28 are formed, which are provided for passing a thread 30 (see FIG. 5) by means of which the flap frame 2 is fastened to the first holding element 24 , In this case, the first holding elements 24 are arranged and dimensioned such that the commissures 12 of the flap frame 2 bear against their free ends and can be sewn there with the threads 30. Thus, the heart valve prosthesis 1 can be firmly fixed to the implantation aid 16 and both parts can be made available to the surgeon as a preassembled unit. After implantation of the heart flap prosthesis 1, the implantation aid 16 can be separated from the first holding elements 24 by cutting the threads 30. It is to be understood that instead of the threads 30 and the holes 28, other suitable attachment means may be formed on the first support members 24 to releasably fix the commissures 12 of the flap frame 2. [30] In addition to the described first holding elements 24, the implantation aid 16 has three second holding elements 32 on its holding section 22. The second holding elements 32 serve to grip the arcuate sections 10 of the flap frame 2 between the commissures 12.

The second Halteelemenfe 32 are elongated or sfabförmig formed and pivotable with its first axial end to the support member 18 articulated. For this purpose, the carrier element 18 has recesses 34 on its outer circumference, which each form part of the joint for the articulation of a second holding element 32. The second Halfeelemente 32 have at their first axial end, which is adjacent to the carrier 18, peg-shaped projections 36, which form pivot pins as part of the joint. The projections 36 engage in the recesses 34, so that the second Halteelemenfe 32 are pivotally mounted on the Trägerelemenf 18. In this case, the pivot axes extend tagenfial the circumference of the Trägerelemenfes 18 about the longitudinal axis X. At its opposite second axial end, the second Halteelemenfe 32 engagement means in the form of radially inwardly open Nufen 38 on. The grooves 38 of the three second holding elements 32 are thus facing each other and extending in the circumferential direction or tangential to the longitudinal axis X. The grooves are formed so that they can embrace the arcuate portions 10 of the flap frame 2 from the radial outer soap ago. By pivoting the second half members 32 about their articulation on the Trägerelemenf 18, the free ends of the second Halfeelemente 32, on which the Nufen 38 are located, radially relative to the longitudinal axis X are moved apart or towards each other. When the holding elements 32 are pivoted radially inwards, the arcuate sections 10 of the flap frame 2, which are located in the grooves 38, are thus also moved radially inward so that the heart valve profile 1 is compressed in the radial direction. is reduced in size and reduced in cross-section transverse to the longitudinal axis S.

For carrying out this pivoting movement of the second holding elements 32, an actuating element in the form of a nut 42 and a sleeve-shaped or cage-shaped annular body 40 are provided. The nut 42 has a longitudinally extending X extending through hole 44 with an internal thread which is in engagement with an external thread 46 on the support member 18. The external thread 46 has a larger diameter than the thread of the handle portion 20, so that the nut 42 can be moved over the handle portion 20 away and screwed onto the thread 46. By turning the nut 42 on the thread 46, the nut 42 is simultaneously moved in the axial direction X on the support member 18.

The ring body 40 is formed so that it is guided in the axial direction X with three radially inwardly directed ribs 48 in three longitudinal grooves 50 on the outer circumference of the carrier element 18. With a first axial end of the annular body 40 abuts against the nut 42. The annular section at the second axial end of the annular body 40 rests with its inner circumference on the outer side of the second holding elements 32. The inner circumference of the ring body 40 substantially corresponds to the outer circumference of the carrier element 16 in the region of the recesses 34, ie the articulation of the second holding elements 32. When the ring body 40 is displaced in the axial direction to the second axial end of the implantation aid 16, ie to the holding portion 22 , the ring body 40 is displaced on the second holding elements 32 so that they are directed radially inwards. This axial movement of the annular body 40 is achieved by screwing the nut 42 onto the external thread 46. When the elastically deformable flap frame 2 lies in the grooves 38, this flap frame 2 is elastically deformed radially inward. At the same time, the valve by its elastic deformation on an elastic restoring force on the second holding elements 32, which acts radially outward. Due to the oblique orientation of the second holding elements 32 to the longitudinal axis X, an axial force can be effected at the same time on the annular body 40, which presses against the nut 42. When the nut 42 is rotated in one direction so that it is unscrewed from the external thread 46 and moves in the axial direction of the holding portion 22 away and to the handle portion 20, displaced by this restoring force of the ring body 40 accordingly with in the axial direction and the second holding elements 32 can deflect radially outward, as a result of which the flap frame 2 widens again in the radial direction in the region of its arcuate sections 10.

[34] The described implantation aid is now used in the following way. The heart valve prosthesis 1 shown in FIG. 1 is first sewn with its commissures 12 by means of threads 30 to the holes 28 of the first holding elements 24. This can be done before the second holding elements 32, the annular body 40 and the nut 42 are mounted on the carrier element 18. In the second step, the second holding elements 32 are inserted with their projections 36 in the recesses 34 and the ring body 40 is pushed onto the support member 18. Subsequently, the nut 42 is screwed onto the thread 46, wherein the ring body 40, as described above, is displaced in the axial direction X and thereby compresses the second holding elements 32 radially inwardly, wherein the second holding elements in the recesses 34 pivot about their projections 36 , The arcuate portions 10 of the valve frame 2 of the heart valve prosthesis 1 are gripped by the grooves 38 of the second holding elements 32 and also moved radially inwardly. Thus, the heart valve prosthesis 2 is then kept fixed in its radially reduced state. The unit assembled from implantation aid 16 and heart valve denture 1 can be delivered in this form to the surgeon. This then fixes on the handle portion 20, if necessary, a longer handle for better handling and sews the heart valve prosthesis 1 to the suture ring 14 in the blood vessel. In this case, the handling and holding of the prosthetic heart valve via the implantation aid 1 to the handle portion 20 and possibly a handle attached to the handle portion 20 takes place. After sewing the heart valve prosthesis 1, the nut 42 is unscrewed from the thread 46, if necessary after prior removal of a handle from the handle portion 20, the ring body 40 due to the described elastic restoring forces of the valve frame 2 in the axial direction X on the Support member 18 is moved so that the second holding elements 2 pivot apart in the radial direction. In this case, the flap frame 2 with its curved sections 10 moves back to its original shape. When the nut 42 is completely unscrewed from the external thread 46, the ring body 40 can also be withdrawn from the carrier element 18 in the axial direction. Subsequently, the three second holding elements 32 can be removed from the recesses 34, so that only the first holding elements 24 are connected to the heart flap prosthesis 1. In the last step, the threads 30 can then be severed, so that the carrier element 18 can also be removed from the heart valve prosthesis 1.

LIST OF REFERENCE NUMBERS

1 - heart valve prosthesis

2 - flap frame

4 - flap sails

6 - first axial end

8 - second axial end

10 - arcuate portions of the flap frame 2

12 - commissures

14 - sewing ring

1 6 - Implantation aid

18 - carrier element

20 - Handle section with thread

22 - holding section

24 - first holding elements

26 - Footbridges

28 holes

30 - threads

32 - second holding elements

34 - recesses

36 - protrusions

38 - grooves

40 - ring body

42 - Mother

44 - Through hole with internal thread

46 - external thread

48 - ribs

50 - longitudinal grooves

5 - Flow or longitudinal axis of the heart valve prosthesis 1 X - longitudinal axis of the implantation aid 16

Claims

claims

An implantation aid (16) for a biological heart valve prosthesis (1) which has a handle section (20) serving to handle the implantation aid (16) and a holding section (22) for holding the heart valve prosthesis (1)

the implantation aid (16) is designed to be attached with its holding section (22) to an axial end (6) of the heart valve prosthesis (1), and

the holding section (22) has first holding elements (24), which are designed to fix the commissures (12) of the heart valve prosthesis (1), and second holding elements (32), which are designed with regions located between the commissures ( 10) of the heart valve prosthesis (1) to engage, and which in the radial direction with respect to a flow direction (S) of the heart valve prosthesis (1) are movable.

Implantation aid according to claim 1, wherein three first holding elements (24) and three second holding elements (32) are present.

Implantation aid according to claim 1 or 2, wherein the first holding elements (24) fastening means (28, 30) for attachment to the commissures (12) of a heart valve prosthesis (1), wherein the fastening means are preferably formed as holes (28) through which Threads (30) can be guided for sewing with the commissures (12).

Implantation aid according to one of the preceding claims, in which the second holding elements (32) comprise engagement means (38) which are designed such that they can be detachably connected to a A flap frame (2) of a heart valve prosthesis (1) can engage, wherein the engagement means are preferably formed as grooves (38) in a manner that they can engage around the flap frame (2) from its radially outer side.

Implantation aid according to one of the preceding claims, wherein the second holding elements (32) with an actuating element (40, 42) are coupled, via which the second holding elements (32) are movable in the radial direction, wherein the actuating element (42) is preferably designed to be rotatable ,

Implantation aid according to one of the preceding claims, wherein the second holding elements (32) are pivotally and preferably releasably articulated to a support member (18).

Implantation aid according to claim 6, wherein the first holding elements (24) fixedly connected to the carrier element (18) and are preferably formed integrally therewith.

8. implantation aid according to claim 6 or 7, wherein the handle portion (20) on the carrier element (18) is formed.

Implantation aid according to one of claims 6 to 8, wherein the second holding elements (32) are pivotally connected in the radial direction on the outer circumference of the carrier element (18) and are surrounded on the outside by a relative to the carrier element (18) axially movable annular body (40), which at the second holding elements spaced from the articulation (34, 36) on the carrier element (18) rests in such a way that the second holding elements (32) of the annular body (40) are pressed radially inwardly.

10. implantation aid according to claim 9, wherein the annular body (40) on the carrier element (18) axially movably guided and by an on the support element (18) arranged actuating element (42) in at least one direction axially (X) is movable. 1 1. An implantation aid according to claim 10, wherein the actuating element (42) has a thread which is in engagement with a corresponding thread (46) on the carrier element (18) in such a way that the actuating element (42) rotates on the thread (46). is moved axially on the carrier element (18), wherein the actuating element (42) is preferably completely removable from the thread (46) on the carrier element (18).

12. Implantation aid according to one of the preceding claims, in which the grip section (20) has a thread on which a handle can be detachably fastened.

13. Heart valve prosthesis system comprising a biological heart valve prosthesis (1) and an implantation aid (16) according to one of the preceding claims, wherein the heart valve prosthesis (1) comprises a valve frame (2), with which the second holding elements (32) of the implantation aid (16 ) can engage in such a way that the flap frame (2) is elastically deformed by the radial movement of the second holding elements (32) and reduced in its cross-section.

14. A prosthetic heart valve system according to claim 13, wherein the second holding elements (32) by an actuating element (42) are movable radially inwardly against a restoring force generated by the elastic deformation of the flap frame.

15. Herzkloppenprothesensystem according to claim 13 or 14, wherein the heart valve prosthesis (1) at the axial ends of their commissures (12) with the first holding elements (24) of the implantation aid (16) releasably connected and in particular sewn.