WO2018050202A1

WO2018050202A1 - Heart implant

Info

Publication number: WO2018050202A1
Application number: PCT/EP2016/001564
Authority: WO
Inventors: Thomas Gerhardt; Raz Bar-On; Stefan Menzl; Leah KIDNEY; Niklas Maximilian NATHE; Youssef Biadillah; Merle ALLERDIßEN
Original assignee: Coramaze Technologies Gmbh
Priority date: 2016-09-16
Filing date: 2016-09-16
Publication date: 2018-03-22

Abstract

The invention relates to a heart implant, particularly being configured to reduce or eliminate a heart valve insufficiency after implantation into the heart, comprising a closure element being positionable within the heart valve annulus, particularly being configured to close or at least to reduce a remaining gap between closing valve leaflets, the closure element comprising a tubular attachment element (1) and a sheath (2) at least partially surrounding the tubular attachment element, the sheath being formed of a hose having two opposite end areas, particularly two opposite tapered neck forming end areas, the sheath being attached to the tubular attachment element in the respective end areas to provide an inflatable lumen between the sheath and the attachment element and an anchoring element (C) being attached to the closure element, particularly to the tubular attachment element of it, for fixing the implant in the heart, preferably for non-invasive fixing by surface contact between the exterior surface of the anchoring element and an interior surface of a heart lumen, preferably the atrium, wherein at least one of the end areas of the hose comprises a surface area being turned outside in and being surrounded by the sheath itself.

Description

Heart Implant

Technical Field

The invention relates to a heart implant, particularly a heart implant being configured to reduce or eliminate a heart valve insufficiency after implantation into the heart.

Background of the invention

Typically, such implants are positioned in such a way that a closure element of the implant is situated in the valve annulus and closes a remaining gap of the closed valve leaflets. For that purpose, the closure element is connected to an anchoring element being configured to fix the closure element within the heart in the desired position i.e. in the valve annulus preferably to be contacted by the closing valve leaflets.

It is known in the art to use an anchoring element punctured into the myocardium of the ventricle for fixation of the closure element. Besides this invasive way modern implants provide a less invasive fixation just by contacting the interior wall of the atrium and/or the ventricle with the outer surface areas of an anchoring element formed of an expanded cage that is connected to the closure element. Anchoring elements, particularly the ones formed as a cage may be attached to the closure element on the atrial and/or ventricular side, most preferred only on the atrial side of the closure element. Such cage and closure element typically is in a collapsed state for feeding the entire implant through a catheter into the heart where it is expanded after release from the catheter for fixation purposes.

The invention generally relates to implants having an expandable closure element, no matter how the anchoring element is realized and preferably the invention relates to implants having an expandable closure element attached to an anchoring element formed as a cage of several strips, preferably interconnected strips forming a mesh. A cage may also be formed without meshes, particularly just by several side-by-side-lying strips having no interconnection. The invention in general also relates to non-meshed cages.

Applicants own patent applications having the serial numbers DE 10 2015 005 934.3 and EP 16000475.0 already disclose a heart implant comprising a tubular attachment element for attaching a sheath to it. In these documents the sheath is formed of an inflatable membrane. After attaching, particular fluid tight attaching an inflatable membrane that may be inflated by a liquid the expanded membrane and the tubular attachment element surrounded, preferably coaxially surrounded by the membrane form the aforementioned closure element that is to be positioned in the respective heart valve annulus. The membrane may be made of a flexible or elastic material, preferably a foil. An expanded membrane encircles a space surrounding the tubular attachment element that reduces or eliminates a gap between the leaflets.

The invention furthermore described in this specification also relates to such heart implant having such a sheath attached to a tubular attachment element.

In the mentioned state of the art and in this invention such an inflatable membrane or sheath forms an inflatable balloon to which the leaflets of a valve directly coapt.

In the known documents the sheath is formed of a hose having tapered end areas / necks, accordingly the end areas of the hose have in the expanded state a smaller cross section / diameter compared to the part of the hose in between. The end areas are attached to the tubular attachment element by sealingly contacting they inner surface of the hose to the exterior surface of the tubular attachment element. In this construction the tapered end areas of the sheath or balloon formed by it do not contribute to the surface area of the expanded closure element to which the leaflets of a heart valve, preferably the mitral valve may coapt.

In the case that forces are exerted to the hose in an axial direction the tapered necks of the hose are deformed on either side, one side being compressed and the other being stretched. Such repeated deformation may lead to deterioration of the neck area and rupture in the hose at these positions.

Furthermore, in the known construction the lower ventricular end of the tubular attachment element is protruding out of the sheath and may come into traumatic contact with the myocard of the ventricle.

Accordingly, it is an object of the invention to provide an implant having a closure element and at least one anchoring element attached to it preferably at least at the atrial side of the closure element that provides a shorter overall length of the closure element preferably without effecting the axial length of these surface parts of the inflated sheath or balloon that come into contact with the leaflets.

In addition, it is a furthermore preferred object of the invention to provide an atraumatic ventricular end of the implant or closure element.

Any direction mentioned in this application text is to be understood in relation to the implant correctly implanted in the heart, preferably if the closure element is positioned in the valve annulus, preferably of the mitral valve. Accordingly, an upper part of the implant is positioned in the atrium and a lower part is positioned in the ventricle.

Even though the application of the implant is preferred in regard to humans the implant may be also applied to animals, particularly mammalian animals. Summary of the invention

The object is solved by a heart implant, particularly being configured to reduce or eliminate a heart valve insufficiency after implantation into the heart, comprising a closure element being positionable within the heart valve annulus, particularly being configured to close or at least to reduce a remaining gap between closing valve leaflets, the closure element comprising a tubular attachment element and a sheath at least partially surrounding the tubular attachment element, the sheath being formed of a hose having two opposite end areas, particularly two opposite tapered neck forming end areas, the sheath being attached to the tubular attachment element in the respective end areas to provide an inflatable lumen between the sheath and the attachment element, an anchoring element being attached to the closure element, particularly to the tubular attachment element of it, for fixing the implant in the heart, preferably for non-invasive fixing by surface contact between the exterior surface of the anchoring element and an interior surface of a heart lumen, preferably the atrium, wherein at least one of the end areas of the hose comprises a surface area being turned outside in and being surrounded by the sheath itself.

By forming a surface area being turned outside in the turned part of the hose extends at least partially backwards in comparison to the external surface of the hose located prior to the turn. The surface area that is turned outside in thus forms a former exterior surface of the hose that - after producing the turn - is facing towards the exterior surface of the tubular attachment element. In addition, the turned surface area is surrounded by at least a part of the remaining not turned surface area of the hose.

Accordingly, the axial length of the hose having such a turn on at least one of the ends is shorter compared to a hose having no such turn at an end, particularly without reducing the axial length of the inflated balloon that comes into contact with the leaflets. Consequently, in the construction of the invention the distance between the two areas on the exterior surface of the attachment element to which the two

respective end areas of the hose are attached may be reduced in comparison to the know state of the art and as a result the overall length is shortened.

Furthermore, such a surface area being turned outside in provides a better axial length compensation and less deformation in that area if axial forces are exerted to the hose of the sheath. Accordingly, such construction will provide better durability.

In a first preferred embodiment at least the end area of the hose at the ventricular side of the closure element comprises the mentioned surface area being turned outside in, but most preferred in a second embodiment both end areas of the hose comprise a surface area being turned outside in.

In a possible embodiment the surface area being turned outside in is a part of a Z- fold surrounding the tubular attachment area and being formed by the end of the hose being axially displaced towards the opposite end, particularly in the Z-folded state the inner surface of the tapered neck being sealingly attached to the exterior surface of the attachment element.

In another possible embodiment the surface area being turned outside in forms an inverted neck of the hose, in this inverted state the former exterior surface of the hose being sealingly attached to the exterior surface of the tubular attachment element. This embodiment provides the possibility to even more reduce the overall length of the implant.

In an improvement of this embodiment the (lower) end of the tubular attachment element at the ventricular side of the closure element is being spaced apart from the ventricular end of the sheath towards the atrial side. By means of this construction this end of the tubular attachment element may be totally encircled by the surface area being turned outside in. Accordingly, the lower ventricular end of the tubular attachment element is not protruding any longer out of the sheath as known in the cited documents. Consequently, such a lower ventricular end of the closure element is totally atraumatic, because only lower ventricular end of the flexible inflated sheath may come into contact with the myocard.

In this embodiment furthermore at least the end of the sheath at the ventricular side of the closure element may form a convex annular surface that surrounds the longitudinal axis when regarded in axial direction of the attachment element.

In order to furthermore improve the mentioned embodiments an annular space being open in the axial direction of the tubular attachment element and being encircled by the surface area of the sheath that is turned outside in, particularly a space that is positioned between the surface area being turned outside in and the tubular attachment element, may be covered by a coverage, particularly for preventing blood stagnation in such a space. The coverage may be made of a foil, particularly a non-porous smooth foil. In another embodiment the coverage may also be formed of a porous coverage, particularly made of a textile, preferably a knitted or braided textile, for example made of polymer fibers.

The coverage may be formed as a tapered hose, the end of the hose having the bigger cross section being attached to a not turned exterior surface area of the sheath and the end of the hose having the smaller cross section being attached to the exterior surface of the tubular attachment element or to a tapered not turned surface part of the sheath, preferably that itself is attached to the exterior surface of the tubular attachment element.

In all the embodiments mentioned before it does not matter how the anchoring element is established but in a preferred embodiment the anchoring element is formed of an expandable cage comprising several strips, particularly

interconnected strips, the cage being attached, preferably unitarily connected to the tubular attachment element on one or both sides of the tubular attachment element and preferably connected to the attachment element only on its atrial side. According to a first preferred embodiment of an anchor construction the tubular attachment element at the atrial end may be split into several strips, the strips extending away from the tubular attachment element towards the atrium and expanding in their separation thus forming an expandable / expandable cage being disposed totally on the atrial side of the tubular attachment element.

In this construction each one of the strips may be split into two branches, each respective branch being merged into a new strip together with another respective branch of a neighboring strip. Such splitting and merging may take place at least two times, preferably three times.

According to a second preferred embodiment of the invention the tubular attachment element comprises a first axially extending lower tubular part being covered or at least coverable by the sheath and a second axially extending upper tubular part, preferably being external to the sheath, the upper tubular part extending between the first lower tubular part and the upper (atrial) end of the tubular attachment element.

Preferably at the upper atrial end the tubular attachment element is split into several strips, the strips forming an expandable cage and extending in the expanded state from the upper atrial end towards the lower ventricular end of the tubular attachment element and form an expanded cage being positioned around at least the upper part of the tubular attachment element.

At least one of the strips along its extension from the upper end of the tubular attachment element towards the lower end of the tubular attachment element comprises split strip regions in which the strip branches into two strips and merged strip regions, in which two strips, in particular respectively formed of at least one of the strips split beforehand, are merged into one strip.

The lower tubular part and the upper tubular part may be each flexible by means of cuts being positioned in the lateral area of the respective tubular parts. This facilitates to move the entire implant through a catheter in its crimped state. Due to the flexibility the tubular attachment element and the cage forming strips may follow the curves of the catheter.

In an improved construction the lower and the upper tubular flexible parts may be axially spaced by means of a rigid tubular part of the tubular attachment element, preferably the rigid part being formed of the original non-cut tube. Accordingly, in this and other embodiment at least the tubular attachment and preferably the tubular attachment element and the strips of the anchoring cage may be formed of a unitary single tube. Preferably made of a shape memory allay, like nitinol having superelasticity.

The mentioned the rigid tubular part between the two flexible part may forms an area of the tubular attachment element to which the upper atrial end area of the sheath is attached, particularly in an inverted state or state being turned outside in.

The cuts in the lower tubular part and the cuts in the upper tubular part may be arranged in different cut patterns. For example, the cut pattern in the lower tubular part comprises straight cuts, particularly extending axially and / or in

circumferential direction.

The cut pattern in the upper tubular part may comprise at least one straight or helically extending cut.

Description of the figures

Figure 1 A illustrates a first embodiment of the invention in comparison to the known construction (dashed lines), having a first anchoring cage

Figure 1 B illustrates an improvement of Figure 1 A by covering the

ventricular end of the sheath with an additional coverage Figure 2 illustrates a second embodiment of the implant having the same first anchoring cage

Figure 3 illustrates a third embodiment of the implant having the same first anchoring cage

Figure 4 illustrates a forth embodiment of the implant having a second anchoring cage

Figure 5 illustrates a fifth embodiment of the implant having the second anchoring cage

Figure 6 illustrates an improvement of the closure element that is

applicable with any kind of anchoring element

Detailed description of the invention

Each figure is showing the closure element in a cross sectional view, wherein the anchoring element is depicted in a perspective view / 3D projection in a plane. Accordingly, in the figures 1-5 different views are mixed for better emphasis of the inventive features in the closure element.

Figure 1A shows an embodiment of the implant having a tubular attachment element 1 that is surrounded by a sheath 2, preferably formed of a flexible membrane. The sheath being attached to the attachment element forms an inflatable lumen that may be filled with a fluid, preferably a liquid through the lower ventricular end 1a of the tubular attachment element 1 , that may comprise a valve in this position. The fluid may pass through the lateral area of the tubular attachment element that has openings to achieve this. The openings may be formed of cuts 1 b (shown here in the top part only), that may also provide the flexibility of the tubular attachment element. The upper hatched part 1c is preferably closed. The lower ventricular end area 2a of the sheath 2 comprises a surface area 2b of the sheath 2 that is turned outside in. This surface area 2b is the middle part of a Z-fold, that surrounds the tubular attachment area.

This is achieved by axially displacing the tapered end/neck of the hose of the sheath 2 towards the opposite end. The tapered neck is sealingly attached to the exterior surface of the attachment element as generally known from the cited. But in contrast to the known construction that is shown in dashed lines the inventive construction provides a smaller length of the tubular attachment element 1 without negative effect to the axial length 2c of the sheath to which the not shown leaflets coapt.

In the shown embodiment only the lower ventricular end comprises an outside in turn of the sheath. The upper end/neck of the hose is attached to the tubular attachment element 1 in the known fashion, but the upper end may be constructed the same way.

At the top end TE the attachment element 1 is split into several strips 4, preferably by cutting the same mentioned tube in axial direction. According to the invention each strip 4 is furthermore split into two respective branches 4a and 4b, each branch preferably having a cross section smaller than the cross section of the strip 4. Each one of the branches, for example branch 4a, merges together with another branch, for example branch 4b, of a neighboring strip 4 thus forming a new strip 5 at a distance to strip 4 in the direction of extension from bottom to top. The length of a strip 5 formed by merged branches may be smaller than the length of a preceding branch.

Such splitting and merging is performed for all strips 4 and is consecutively repeated for the strips 5 and so on. According to the invention splitting and merging is performed at least two times, here exactly three times. This may apply to all the embodiments described in regard to the figures 1 ,2 and 3. The branched areas preferably form the majority in the total extension of the formed cage C thus providing a significant flexibility to the cage, particularly if it is in the collapsed state for feeding the implant through a catheter. Preferably nonetheless the strips formed of connected branches do not only form a singularity of connection but have a lengthwise extension, particularly each strip has an extension of more than 2 mm, preferably between 2 and 15 mm.

In this embodiment the last strips 7 form strip ends that are connected to an annular element 8, formed of the same tube. Here the annular element 8 is positioned between the proximal part of the cage PP and the distal Part DP of the cage C (regarded in the direction of implantation).

The entire cage C may be formed by providing axial cuts in the tubular wall of the original tube that are axially spaced and interdigitated in circumferential direction. By raising the distance of the so formed strips and branches to the axis A the anchoring cage C may be formed. The specific shape of the cage is "teached in" the shape memory metal of the tube, like nitinol.

It can be seen in Figure 1 A that in this preferred embodiment the cage C formed of all strips 4,5,6,7 and branches 4a,4b, 5a, 5b and 6, 6b comprises several strips, preferably the respective last but one strips 6 being formed of merged branches 5a, 5b that have a curved section CS being convex to a non-shown heart wall and concave towards the proximal part PP. Such a respective curved section CS preferably has a tangent T perpendicular to the central axis A of the tubular element 1. Accordingly, each such curved section CS comprises a part being bent back from the distal part towards the proximal part PP of the cage. Each such curved section CS of a strip 6 may form a first part of an S-shaped configuration wherein the second part of this S-shaped configuration is formed at least in part of the last branches 6a, 6b into which the strip 6 is split along the extension. Each one of the last branches 6a, 6b is accordingly bent towards the distal part again and also has a non-shown tangent perpendicular to the axis A. The part of the cage C opposite to the tubular element 1 has a concave part CP surrounding the central axis A and being depressed towards the inner volume of the cage C and preferably concave towards the heart wall. Consequently, the connected ends 7 or the free ends 7 of consecutively discussed embodiments will be free of contact to the heart wall. This shown construction may also apply to all embodiments of Figures 1 ,2,3.

Figure 1 B illustrates an improvement of the embodiment shown in figure 1A.

According to these two figures the Z-fold comprises an annular space 2d, that is open in axial direction, in this case towards the ventricle if the implant is in its intended place. The annular space is surrounded in circumferential direction by the surface area 2b of the sheath 2 that is turned outside in.

In this space 2d blood stagnation may occur and may lead to thrombus formation. According to the improvement this annular space 2d is covered by a coverage 2e to prevent stagnation in that space 2d. The coverage 2e is formed of a tapered hose 2e, the end of this hose 2e having the bigger cross section is attached to the sheath 2, preferably near the axial end of this sheath 2, in a surface area where this sheath 2 is not turned outside in. The end of the hose 2e having the smaller cross section is attached to the tapered not turned surface part of the of the sheath, that itself is attached to the exterior surface of the tubular attachment element 1.

In figure 1 B the coverage 2e is shown with a small distance to the sheath 2. This is just for better visibility. In the real construction the coverage 2e is connected to the sheath 2 and / or attachment element 1.

In contrast to figures 1 A and 1 B the figure 2 shows an embodiment of the closure element wherein the lower end area 2a of the sheath 2 is not just turned outside in but totally inverted, i.e. turned by 180 degrees. Accordingly, here the former exterior surface of the not inverted area is in the inverted state facing the exterior surface of the attachment element 1 and sealingly attached to it. It can also be seen by comparison with the dashed lines showing the state of the art that the overall length may be even more reduced.

The lower ventricular end 1a of the tubular attachment element 1 is offset towards the atrium in relation to the lower ventricular end 2d of the sheath 2 as illustrated by the dashed line DL. Accordingly, the lower end 1a does not protrude beyond the annular convex shaped sheath end 2d and may not harm he myocard.

Figure 3 shows the same construction as described in figure 2, but the upper atrial end of the sheath also inverted.

Figure 4 shows an embodiment having the same construction of the closure element comprising the tubular attachment element 1 and the sheath 2 as described in Figure 2, but having a different anchoring cage construction.

The cage C is formed of several strips 4 emerging from the upper end 1 b of the tubular attachment element 1 that are each split into two split strip regions 4ss. Neighboring spilt strip regions 4ss are recombined to merged strip region 4ms, the merged strip regions 4ms being split again into split strip regions 4ss and these ones being recombined to merged strips regions that - in this case - form respective free strip ends 4e. The free strip ends may have orifices or pinholes 9 in all embodiments, particularly for feeding a pull wire through the orifices and thus for temporarily connecting the free strip ends 4e.

In these embodiments of the invention and also in Figure 5 the upper end 1 b of the attachment element 1 supports a cage C having a shape comparable to an umbrella that spans the attachment element 1. More than 50% of the axial length of the tubular attachment element 1 is surrounded by the cage C.

In contrast to the cage for Figure 1 , 2, 3 here the cage forming strips 4 extend from the top end 1 b of the tubular attachment element after a bent backwards to the lower ventricular end. Here the inflatable sheath 2 is attached to a lower tubular part 1d and surround it. The upper tubular part 1 e is separated from the lower one by a rigid tubular part 1f. The rigid tubular part 1f and the lowermost rigid tubular part 1g serve to attach the lower and upper ends of the inflatable sheath 2. The upper tubular part 1e is totally external to the sheath.

The lower tubular part will have also cuts 1 b to provide the required flexibility.

In this embodiment the lower and upper tubular parts have different cut pattern to provide flexibility but different axial stiffness in the two parts. The upper part 1e comprises at least two straight cuts 3b. The cuts may also be helically wound.

Figure 5 shows a closure element as described in Figure 3 but having the anchoring cage of figure 4.

Figure 6 illustrates an improvement that is applicable to closure elements having inverted necks at the atrial and / or ventricular side of the sheath 2. If at least one inverted neck of the sheath 2 is provided the annular space 2d, that is already explained in regard to figure 1 B may be covered by a coverage 2e, particularly to prevent blood stagnation.

If on both sides inverted necks are provided having surface areas being turned outside in by 180 degrees, the coverage 2e is preferably attached to cover the space 2d on both sides.

On both sides the coverage has at one of its ends a bigger cross section and on the other end a smaller cross section. The end of the coverage 2e having the bigger cross section is attached to a not turned exterior surface area of the sheath 1 and the end of the coverage 2e having the smaller cross section is attached directly to the exterior surface of the tubular attachment element 1.

As can be seen by the dashed line in figure 6 the two coverages 2e on either sides may be separate but may also be formed unitarily, i.e. in one part. For reasons of visibility also here the coverage 2e is shown with a small distance to the sheath 2 and the attachment element 1. In the real construction the coverage 2e is connected to the sheath 2 and / or attachment element 1 without distance.

In all embodiments that have an additional coverage 2e the coverage may also be formed of a porous membrane to promote endothelialisation.

Claims

1. Heart implant, particularly being configured to reduce or eliminate a heart valve insufficiency after implantation into the heart, comprising

a. a closure element being positionable within the heart valve annulus, particularly being configured to close or at least to reduce a remaining gap between closing valve leaflets,

b. the closure element comprising a tubular attachment element and a sheath at least partially surrounding the tubular attachment element, c. the sheath being formed of a hose having two opposite end areas, particularly two opposite tapered neck forming end areas, the sheath being attached to the tubular attachment element in the respective end areas to provide an inflatable lumen between the sheath and the attachment element

d. an anchoring element being attached to the closure element,

particularly to the tubular attachment element of it, for fixing the implant in the heart, preferably for non-invasive fixing by surface contact between the exterior surface of the anchoring element and an interior surface of a heart lumen, preferably the atrium, wherein at least one of the end areas of the hose comprises a surface area being turned outside in and being surrounded by the sheath itself.

2. Heart implant according to claim 1 , wherein at least the end area of the hose at the ventricular side of the closure element comprises the surface area being turned outside in.

3. Heart implant according to claim 1 , wherein both end areas of the hose comprise a surface area being turned outside in.

4. Heart implant according to anyone of the preceding claims, wherein the surface area being turned outside in is a part of a Z-fold surrounding the tubular attachment area and being formed by the end of the hose being axially displaced towards the opposite end, particularly in the Z-folded state the inner surface of the tapered neck being sealingly attached to the exterior surface of the attachment element.

5. Heart implant according to anyone of the preceding claims, wherein the surface area being turned outside in forms an inverted neck of the hose, in this inverted state the former exterior surface of the hose being sealingly attached to the exterior surface of the tubular attachment element.

6. Heart implant according to anyone of the preceding claims, wherein the end of the tubular attachment element at the ventricular side of the closure element is being spaced apart from the ventricular end of the sheath towards the atrial side, particularly this end of the tubular attachment element being totally encircled by the surface area being turned outside in.

7. Heart implant according to anyone of the preceding claims, wherein at least the end of the sheath at the ventricular side of the closure element forms a convex annular surface that surrounds the longitudinal axis when regarded in axial direction of the attachment element.

8. Heart implant according to anyone of the preceding claims, wherein an

annular space being open in the axial direction of the tubular attachment element and being encircled by the surface area of the sheath that is turned outside in, particularly a space that is positioned between the surface area being turned outside in and the tubular attachment element, is covered by a coverage, particularly a porous coverage.

9. Heart implant according to claim 8, wherein the coverage is formed of a tapered hose, the end of the hose having the bigger cross section being attached to a not turned exterior surface area of the sheath and the end of the hose having the smaller cross section being attached to the exterior surface of the tubular attachment element or to a tapered not turned surface part of the sheath, preferably that itself is attached to the exterior surface of the tubular attachment element.

10. Heart implant according to anyone of the preceding claims, wherein the tubular attachment element at the atrial end is split into several strips, the strips extending away from the tubular attachment element towards the atrium and expanding in their separation thus forming an expandable / expandable cage being disposed totally on the atrial side of the tubular attachment element.

11. Heart implant according to claim 10 wherein each one of the strips being split into two branches, each respective branch being merged into a new strip together with another respective branch of a neighboring strip.

12. Heart implant according to claim 11 , wherein such splitting and merging take place at least two times, preferably three times.

13. Heart implant according to anyone of the preceding claims 1 to 8, wherein the tubular attachment element comprises a first axially extending lower tubular part being covered or at least coverable by the sheath and a second axially extending upper tubular part, preferably being external to the sheath, the upper tubular part extending between the first lower tubular part and the upper end of the tubular attachment element.

14. Heart implant according to claim 13, wherein at the upper atrial end the tubular attachment element is split into several strips, the strips forming an expandable cage and extending in the expanded state from the upper atrial end towards the lower ventricular end of the tubular attachment element and form an expanded cage being positioned around at least the upper part of the tubular attachment element.

15. Heart implant according to claim 14, wherein at least one of the strips along its extension from the upper end of the tubular attachment element towards the lower end of the tubular attachment element comprises split strip regions in which the strip branches into two strips and merged strip regions, in which two strips, in particular respectively formed of at least one of the strips split beforehand, are merged into one strip.

16. Heart implant according to anyone of the claims 13 to 15, wherein the lower tubular part and the upper tubular part are each flexible by means of cuts being positioned in the lateral area of the respective tubular parts.

17. Heart implant according to claim 16, wherein the lower and the upper

tubular flexible parts are axially spaced by means of a rigid tubular part of the tubular attachment element, preferably the rigid part being formed of the original non-cut tube.

18. Heart implant according to claim 17, wherein the rigid tubular part forms an area of the tubular attachment element to which the upper atrial end area of the sheath is attached.

19. Heart implant according to anyone of the claims 16 to 18, wherein the cuts in the lower tubular part and the cuts in the upper tubular part are arranged in different cut patterns.

20. Heart implant according to claim 19, wherein the cut pattern in the lower tubular part comprises straight cuts, particularly extending axially and / or in circumferential direction.

21. Heart implant according to claim 19 or 20, wherein the cut pattern in the upper tubular part comprises at least one straight or helically extending cut, preferably in both alternatives predominantly extending in axial direction of the tubular attachment element.