DOUBLE STENT

Abstract

The invention relates to a double stent comprising two coaxially arranged stents (2, 3), wherein a first membrane (4) being arranged between a first inner stent (2) and the second outer stents (3), and a second membrane (5) being arranged on the second stent (3), with the membrane ends of the first and second membrane (4, 5) being brought together at the ends of the stents (2, 3) and folded over onto the inside of the first stent (2) and secured/fixed there.

Claims

1. Double stent comprising two coaxially arranged stents (2, 3), wherein a first membrane (4) is arranged between a first inner stent (2) and the second outer stent (3) and a second membrane (5) is arranged on the second stent (3), wherein the membrane ends of the first and the second membrane (4, 5) are brought together at the ends of the stents (2, 3) and folded over onto the inner side of the first stent (2) and secured/fixed there, characterized in that the first inner stent (2) is made of a first material and the second outer stent (3) is made of a second material.

2. Double stent according to claim 1, characterized in that one of the stents (2 or 3) consists of a cobalt-chromium alloy.

3. Double stent according to claim 1, characterized in that one of the stents (2 or 3) consists of a shape-memory alloy, in particular of Nitinol.

4. Double stent according to claim 1, characterized in that one of the stents (2 or 3) consists of a biologically degradable plastic material.

5. Double stent according to claim 1, characterized in that the second outer stent (3) consists of a cobalt-chromium alloy and the first inner stent (2) consists of a shape-memory alloy, in particular of a nickel-titanium alloy.

6. Double stent according to claim 5, characterized in that the first inner stent (2) is 5 to 10 mm, preferably 8 mm, longer than the second outer stent (3) and, in its final form as determined by its shape memory characteristics, has a diameter 1 to 6 mm, preferably 3 mm, larger than the diameter of the second outer stent (3).

7. Double stent according to claim 6, characterized in that the first inner stent (2) is provided at its proximal end with additional fixation elements, in particular in the form of barbs and/or a trumpet-shaped widening.

8. Double stent according to claim 1, characterized in that the second outer stent (3) consists of a nickel-titanium alloy with shape-memory characteristics and the first inner stent (2) consists of a cobalt-chromium alloy.

9. Double stent according to claim 1, characterized in that the second outer stent (3) consists of a biologically degradable plastic material and the first inner stent (2) consists of a cobalt-chromium alloy.

10. Double stent according to claim 1, characterized in that both stents (2, 3) are of different length.

11. Double stent according to claim 1, characterized in that at least the first inner stent (2) is provided with a plurality of ring segments (7, 7a, 7b) arranged side by side and having a meandering structure, said ring segments being connected to one another by means of connecting webs (8, 9).

12. Double stent according to claim 1, characterized in that the membranes (4, 5) are secured/fixed by gluing/bonding, sewing, welding or clamping.

13. Double stent according to claim 1, characterized in that the membranes (4, 5) are clamped in place in or between the flexible tongues (6) formed by applying incisions in the meandering arches of the first stent (2).

14. Double stent according to claim 13, characterized in that the flexible tongues (6) point to the outside of the stent.

15. Double stent according to claim 13, characterized in that the flexible tongues (6) are arranged in the peripheral regions of the first stent (2).

16. Double stent according to claim 15, characterized in that the flexible tongues (6) are formed on ring segments (7b) which are arranged adjacent to the peripheral ring segments (7a).

17. Double stent according to claim 11, characterized in that the connecting webs (8) of the first inner stent (2) and second outer stent (3) are arranged with gaps between them.

18. Double stent according to claim 1, characterized in that the first membrane (4) and/or second membrane (5) consists of plastic material.

19. Double stent according to claim 18, characterized in that the first membrane (4) and/or the second membrane (5) consists of PTFE.

Description

[0029] Further elucidation of the invention is provided through the enclosed figures showing preferred embodiments of the invention. It goes without saying that the characteristics shown in the figures shall in each case be regarded individually as being part of the invention and should not be understood exclusively in the context of the other characteristics illustrated in the figures, where

[0030] FIG. 1: illustrates schematically a longitudinal section through the end area of the wall of a double stent according to the invention;

[0031] FIG. 2: shows a top view of the developed wall of the inner stent in the area of its end section;

[0032] FIG. 3: shows a variant with respect to FIG. 2.

[0033] The double stent proposed by the invention and designated in FIG. 1 as a whole with the reference numeral 1 comprises a first inner stent 2 and a second outer stent 3 which are arranged coaxially to each other. The outer stent 3 is slightly shorter than the inner stent 2. The entire double stent 1 is shown in the non-expanded state. Between the inner stent 2 and the outer stent 3 a first inner membrane 4 is provided. The outer stent 3 is surrounded by a second outer membrane 5. Both membranes 4 and 5 are made of ePTFE.

[0034] The inner membrane 4 and the outer membrane 5 are brought together at their ends and folded inwardly into the hollow space of the inner stent 2 around the upper edge of the double stent 1. Shown as an example is one of several flexible tongues 6 forming part of the inner stent 2, said tongues being bent inwards and serving to clamp in place the inwardly folded edges of the membranes 4 and 5.

[0035] The inner stent 2, as illustrated in FIG. 1, is expediently manufactured of a suitable shape memory alloy, for example of nickel-titanium (Nitinol), and has proximally an excess length of 5 mm to 10 mm, preferably 8 mm. Moreover, in its final state which is determined by its shape memory characteristics, it has a diameter that is 1 to 6 mm, preferably 3 mm larger than the diameter of the outer stent 3. This ensures that the inner membrane 4 always remains sufficiently tightly clamped between the inner stent 2 and the outer stent 3. For better anchoring in a vessel or prosthesis, the stent 2 may additionally be fitted with radially protruding barbs or have a trumpet-shaped formation, which can be coated with ePTFE if required.

[0036] In FIG. 2 the design of the wall of the inner stent 2 has been illustrated in its end area, which is also shown in FIG. 1, but in this case depicting a specific design of the flexible tongues 6, which are only shown schematically in FIG. 1.

[0037] As can be seen from FIG. 2, the wall of the inner stent 2 in the longitudinal region of the stent 2 consists of a plurality of ring segments 7, each of which has a circumferential, meandering band. These meandering bands are axially connected to each other by connecting webs that are resilient in the axial direction. In this respect, the wall structure of the inner stent 2 corresponds to the widely adopted common way of constructing stents.

[0038] In contrast to the customary stents, the stent 2 depicted in FIG. 2 has two differently designed ring segments 7a and 7b in the end area, which have been provided with a view to forming out the flexible tongues of the first inner stent 2, which are designated with the reference numeral 6 in FIG. 1 above. In this case, the ring segment 7a forms the final outer edge of the stent 2, while the ring segment 7b is located between the outer edge and the longitudinal area of the stent 2, refer to DE 10 2015 106 052 A1.

[0039] Each of the two ring segments 7a and 7b exhibit as well a circumferential, meandering band. The meandering arches of both ring segments 7a and 7b pointing towards the longitudinal area of the stent 2 are connected to each other by axially extending connecting webs 9. In contrast, the meandering arches of the two ring segments 7a and 7b pointing towards the end of stent 2 are not connected to each other. Instead, the meandering arches of ring element 7b pointing towards the end of stent 2 are provided with blind webs 10, which protrude into the meandering arches of ring segment 7a oriented in the same direction, without being connected to them. These blind webs 10, in conjunction with the meandering arches of the ring segment 7b carrying them, form the flexible tongues which are only shown schematically in FIG. 1 and are designated there with the reference numeral 6.

[0040] FIG. 3 shows another possible way of forming the flexible tongues referred to hereinbefore, which are marked with the reference numeral 6 in FIG. 1. For this purpose, a ring segment 7c is provided at the end of the inner stent 2, which also has a circumferential, meandering band, the meandering arches of which pointing towards the end of the stent 2 are provided with incisions 11 over their length and thus form elastically deformable flexible tongues capable of clamping between themlike paper clipsthe ends of membranes 4 and 5 shown in FIG. 1, refer to WO 2012/084202 A2.