Intraluminal vascular prosthesis for implantation into the heart or cardiovascular vessels of a patient

Abstract

The present invention concerns an intraluminal vascular prosthesis for implantation into the heart and/or cardiac vessels of a patient, in particular for anchoring in the region of the cardiac valve leaflets. The vascular prosthesis comprises a stent support and a prosthesis material at least partially covering the stent support, such, that a covered proximal portion and a non-covered distal portion are formed. Furthermore, the vascular prosthesis has at least one elongate wire-shaped anchoring structure at the proximal end, which is substantially loop-shaped and which is fixed at two ends to the stent support and which is positioned with its proximal end in the form of a loop pointing in the proximal direction and projecting beyond the proximal end of the stent support.

Claims

1. An intraluminal vascular prosthesis adapted for implantation into a heart and/or into cardiovascular vessels of a patient, for anchoring in a region of cardiac valve leaflets, the vascular prosthesis having a distal and a proximal end, the vascular prosthesis having a stent support, and a prosthesis material with which the stent support is at least partially covered, such that a covered proximal portion and a non-covered distal portion are formed, wherein the vascular prosthesis comprises, at the proximal end, at least one elongate wire-shaped anchoring structure which is loop-shaped and which via two ends is fixed to the stent support and which is positioned with its proximal end in the form of a loop pointing towards the proximal direction and projecting beyond the proximal end of the stent support, wherein the distal ends of the wire-shaped anchoring structure are positioned at immediately adjacent corners to two diamond-shaped cells.

2. The intraluminal vascular prosthesis according to claim 1, wherein the wire-shaped anchoring structure comprises a trapezoidal extension in a region of the loop.

3. The intraluminal vascular prosthesis according to claim 1, wherein an outermost proximal end of the wire-shaped anchoring structure is drop-shaped.

4. The intraluminal vascular prosthesis according to claim 1, wherein the stent support is a laser-cut stent support or a braided or woven stent support.

5. The intraluminal vascular prosthesis according to claim 1, wherein the stent support and the anchoring structure are integrally formed.

6. The intraluminal vascular prosthesis according to claim 1, wherein one to three anchoring structures are provided at the proximal end of the stent support.

7. The intraluminal vascular prosthesis according to claim 1, wherein the stent support and/or the wire-shaped anchoring structure have hooks or spikes on their respective side facing away from the vascular wall.

8. The intraluminal vascular prosthesis according to claim 1, wherein the stent support has hooks or spikes on its side facing the vascular wall.

9. The intraluminal vascular prosthesis according to claim 1, wherein the stent support and/or the wire-shaped anchoring structure comprises X-ray markers.

10. The intraluminal vascular prosthesis according to claim 1, wherein the vascular prothesis has a diameter of between approx. 20 mm to approx. 48 mm, preferably of between 24 mm to approx. 44 mm.

11. The intraluminal vascular prosthesis according to claim 1, further comprising a heart valve prosthesis, wherein the heart valve prosthesis is configured to be released with its distal end at the proximal end of the intraluminal vascular prosthesis and can be fixed via the latter in the region of the heart valves.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) Embodiments of the invention are shown in the drawing and are explained in more detail in the following description, which show:

(2) FIG. 1 is a schematic representation of an embodiment of a vascular prosthesis according to the invention, in the non-introduced, expanded state in a view of the longitudinal side;

(3) FIGS. 2A, 2B, and 2C are schematic representations of the stepwise release of the vascular prosthesis of FIG. 1, with a schematically depicted release catheter; in the fully charged state (A); with partially retracted compression structure but with the proximal and distal end of the vascular prosthesis still fixed to the release catheter (B); and with released proximal end (C);

(4) FIG. 3 is the schematic representation of an embodiment of the vascular prosthesis according to the invention completely released in the cardiovascular system;

(5) FIG. 4 shows a schematic representation of a system according to the invention, with a heart valve prosthesis anchored in a vascular prosthesis according to the invention, the representation being shown outside the heart vessel.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

(6) In the figures, the same features are marked with the same reference signs, whereby for reasons of clarity not all reference signs are always indicated in all figures.

(7) In FIGS. 1 to 4, reference sign 10 denotes an inventive vascular prosthesis as such, having a distal end 11 and a proximal end 12. The vascular prosthesis has a tubular stent support 14 to which a prosthesis material 16 is attached in a proximal portion 15, thereby covering the proximal portion 15. The vascular prosthesis 10 further comprises a distal section 17 which is free of prosthesis material.

(8) According to the invention, the stent support 14 can be a laser-cut stent-support, or a woven or braided stent support consisting of several wires, or of single, meandering stent rings arranged one behind the other, which are (indirectly) connected to each other only via the prosthesis material.

(9) In the example shown in the figures, the vascular prosthesis 10 has 18 diamond-shaped cells, which form the tubular or cylindrical stent support 14 in a row-like fashion. At the distal end 11, fixing structures 19 are provided at three free corners of the diamond-shaped cells 18 at the distal end 11, via which the distal end 11 of the vascular prosthesis 10 can be received in a release catheter (not shown) in corresponding receptacles or recesses and fixed to the release catheter via a withdrawal sheath (not shown) provided thereover. The fixation structures 19 are T-shaped as shown in FIG. 1.

(10) A wire-shaped anchoring structure 20 is provided at the proximal end 12 of the vascular prosthesis 10, forming a loop 21 in/towards the proximal direction 12′. The anchoring structure 20 is approx. ⅓ of the total length of the vascular prosthesis 10 and extends beyond its proximal end 12.

(11) The anchoring structure 20 has a proximal end 22 with loop 21 formed in the area of the end 22. The anchoring structure 20 further comprises two distal ends 23 and 24 fixed or integral with two free corners 18′, 18″ of the diamond-shaped cells 18 at the proximal end 12 of the vascular prosthesis.

(12) As shown in FIG. 1, the distal ends 23, 24 of the anchoring structure 20 are attached to/integrally with the immediately adjacent corners of the diamond-shaped cells 18 at the proximal end 12 of the vascular prosthesis 10.

(13) Here, “free ends” of the diamond-shaped cells mean, as for any other embodiment of the vascular prosthesis according to the invention, that these corners are not connected to another diamond-shaped cell, but protrude freely in the distal direction 11′ or proximal direction 12′.

(14) FIG. 1 also shows that the anchoring structure 20 in the area of loop 21 has a trapezoidal extension 25 pointing towards the outside. This means that the distance between the distal ends 23, 24 of the anchoring structure 20 in the area of its fixation/attachment to the proximal end 12 of the vascular prosthesis 10 is smaller than the distance between the opposite wires of loop 21 in the proximal area 22.

(15) As shown in FIG. 1, the anchoring structure 20 has an outermost drop-shaped proximal end 26 in its loop 21.

(16) The anchoring structure 20 and the stent support 14 can be formed in one piece, e.g. by laser cutting a corresponding tube or cylinder.

(17) The anchoring structure 20 and/or stent support 14 may have hooks or spikes (not shown) on their respective side facing away from the vessel wall and may include one or more x-ray markers.

(18) The diameter d of the vascular prosthesis according to the invention is preferably between 20 mm and 48 mm, preferably between approx. 24 mm and approx. 44 mm.

(19) FIG. 2 schematically shows the release of a vascular prosthesis 10 loaded on a release catheter 30. The vascular prosthesis 10 is fixed to the release catheter at its distal end 11 via the fixation structures 19 provided there in corresponding recesses and by covering it with a withdrawal sleeve 31. The vascular prosthesis 10 is also detachably fixed via its proximal end 12 to the release catheter 30 via a corresponding system (not shown). The fully fixed and compressed state of the vascular prosthesis 10 is shown in FIG. 2A.

(20) After retraction of the retraction sheath 31 which keeps the vascular prosthesis compressed, a central area of the vascular prosthesis 10 expands balloon-like, while the proximal and distal ends 12, 11 of the vascular prosthesis 10 are still fixed to the release catheter 30 (see FIG. 2B).

(21) After the release of the proximal end 12 of the vascular prosthesis 10, it can expand, whereas the distal end 11 of the vascular prosthesis 10 is still fixed and compressed at the release catheter 30 and through the withdrawal sheath 31 (see FIG. 2C). In this state, the vascular prosthesis 10 according to the invention can be released and positioned at the desired location, preferably behind a leaflet of the aortic valve (see also FIG. 3), preferably behind the non-coronary leaflet or “non-coronary cusp “NCC”. This allows the anchoring structure 20 to be precisely aligned and prevents subsequent proximal migration of the vascular prosthesis.

(22) If the positioning of the anchoring structure 20 is secured, the remaining vascular prosthesis can be released by completely retracting the retraction sheath 31. The completely released state of the vascular prosthesis 10 in a heart 70 is shown in FIG. 3, in which figure the vascular prosthesis is shown in dashed lines for a better overview. It can be seen here that the anchoring structure 20 is positioned behind a leaflet of the aortic valve 71, while the rest of the vascular prosthesis 10 extends distally into/towards the ascending aorta 72.

(23) Finally, FIG. 4 shows a system 50 according to the invention consisting of a vascular prosthesis 10 and a heart valve prosthesis 40 in assembled form, outside the heart for better overview.

(24) As soon as the vascular prosthesis 10 is positioned as an anchor in the heart, the heart valve prosthesis 40 can be inserted over it and released in such a way that the heart valve prosthesis 40 with its distal end 41 in the vascular prosthesis 10 at least partially engages at its proximal end 12 or is already fixed there by expansion.