Abstract
The invention relates to an endoprosthesis (60) which comprises a graft (2), a stent structure (5), a fiber (1) and a suture (3). The suture (3) fixedly attaches the stent structure (5) to the graft (2). The fiber is attached to the endoprosthesis (60) via the suture (3).
Claims
1-14. (canceled)
15. An endoprosthesis comprising a graft, a stent structure, a fiber and a suture, wherein the suture fixedly attaches the stent structure to the graft, wherein the fiber is attached to the endoprosthesis via the suture.
16. The endoprosthesis according to claim 15, wherein the suture has a knot.
17. The endoprosthesis according to claim 16, wherein the knot forms the suture into a substantially closed loop holding together the stent structure and the graft.
18. The endoprosthesis according to claim 16, wherein the knot connects the suture to the fiber.
19. The endoprosthesis according to claim 15, wherein the fiber forms a loop around the suture.
20. The endoprosthesis according to claim 15, wherein the suture forms a continuous stitch.
21. The endoprosthesis according to claim 20, wherein the suture forms a buttonhole stitch.
22. The endoprosthesis according to claim 20, wherein the continuous stitch holds the stent structure and the graft together.
23. The endoprosthesis according to claim 15, comprising at least two fibers, wherein the at least two fibers are connected via a support string.
24. The endoprosthesis according to claim 15, wherein the fiber comprises a knot connecting the fiber to the suture.
25. The endoprosthesis according to claim 15, wherein the fiber is attached to the stent structure and to the graft via the suture.
26. The endoprosthesis according to claim 15, wherein the fiber is a thrombogenic fiber having a free portion configured to extend at least partly away from at least one of the stent and a surface of the graft.
27. The endoprosthesis according to claim 15, wherein the fiber is distinct from at least one of the suture and the graft.
28. The endoprosthesis according to claim 15, wherein the suture is configured to retain attachment of the fiber after implantation of the endoprosthesis.
29. A method of manufacturing an endoprosthesis, comprising the steps of: providing a stent structure, a graft, and a suture; attaching the stent structure to the graft via the suture; and attaching at least one fiber to the endoprosthesis via the suture.
30. The method according to claim 29, wherein the step of attaching at least one fiber to the endoprosthesis via the suture comprises attaching the at least one fiber to the suture.
31. The method according to claim 29, wherein the step of attaching at least one fiber to the endoprosthesis via the suture comprises attaching the at least one fiber via at least one of a loop, a knot, and a support string comprised by at least one of the fiber and the suture.
32. The method according to claim 29, wherein the step of attaching comprises attaching the fiber to the stent structure and to the graft via the suture.
33. The method according to claim 29, wherein the fiber is a thrombogenic fiber.
Description
[0027] In the following, the invention is described in detail with reference to the following figures, showing:
[0028] FIG. 1: a detail of a first embodiment of an endoprosthesis in a cross-sectional view perpendicular to an axis,
[0029] FIG. 2: a detail of a second embodiment of an endoprosthesis in a cross-sectional view perpendicular to an axis,
[0030] FIG. 3: a detail of a third embodiment of an endoprosthesis in a cross-sectional view perpendicular to an axis,
[0031] FIG. 4: a detail of a fourth embodiment of an endoprosthesis in a cross-sectional view perpendicular to an axis,
[0032] FIG. 5: a detail of a fifth embodiment of an endoprosthesis in a view along an axis,
[0033] FIG. 6: a detail of a sixth embodiment of an endoprosthesis in a cross-sectional view along an axis,
[0034] FIG. 7a-7b: a detail of a seventh embodiment of an endoprosthesis in a cross-sectional view perpendicular to and along an axis
[0035] FIG. 8: an exemplary endoprosthesis according to the invention.
[0036] FIG. 1 shows a cross-sectional view of a portion of an endoprosthesis 60 in a plane perpendicular to a longitudinal axis of a strut of the stent structure 5. The endoprosthesis comprises a graft 2 made of a biocompatible polymer material, for example polyethylene terephthalate, and a stent structure 5 formed of struts made of a Nitinol alloy. A suture 3, which in the present case is a Dacron (i.e. polyethylene terephthalate) fiber, is arranged around the stent structure 5 to form a substantially closed loop that penetrates the graft 2. It therefore holds the stent structure 5 and the graft 2 together in a fixed manner. The suture 3 further comprises a knot 4 that forms the substantially closed loop. The knot 4 further connects the suture 3 to two thrombogenic fibers 1 having a free end 9,9′ each. In the present embodiment, the fibers 1 are formed integrally with the suture 3, meaning that the fibers 1 consist of the free ends 9,9′ of the suture. Furthermore, in the present embodiment, the suture 3 forms exactly one loop around the stent structure 5. There may be a plurality of sutures and loops along the axis of the strut. Each loop is formed by one knot 4 which connects the suture 3 to the fiber.
[0037] FIG. 2 shows an alternative embodiment of the endoprosthesis 60. The present embodiment is similar to the embodiment of FIG. 1. Here, the suture 3 and the fiber (e.g. thrombogenic fiber) 1 are configured as separate elements. The suture 3 in this embodiment is a conventional surgical thread known in the art and extends around the stent structure 5. The suture 3 comprises a knot that forms the substantially closed loop. The free ends 10,10′ of the suture do not substantially extend away from the knot. They do not have a substantial thrombogenic effect. The fiber 1 extends through the knot 4 and is attached to the suture 3 via the knot 4. Two free ends 9,9′ of the fiber 1 extend away from the knot. The fiber 1 is made of polyethylene, but may alternatively comprise or consist of polyethylene terephthalate, polyamide, or polyglycolic-lactic acid. The fiber 1 may additionally be functionalized on its surface to increase its thrombogenicity and to increase friction within the knot 4 to achieve a secure attachment.
[0038] FIG. 3 shows an alternative embodiment of the endoprosthesis 60 which is similar to the embodiment of FIG. 2. The fiber 1, however, is not attached to the knot 4 of the suture. Instead, the fiber 1 extends through the substantially closed loop formed by the suture 3 and forms a loop 6 around the suture 3. The loop 6 in the present embodiment is not closed and is only held in position by friction between the suture 3 and the fiber 1. This method of attachment is particularly advantageous because it is easily adaptable and typically faster than conventional methods. The fiber 1 can easily be removed, moved to a different position, or changed in its length. While not shown here, it would of course be possible to additionally use an adhesive, a heat treatment such as welding, or another additional attachment mechanism to create a more secure attachment.
[0039] FIG. 4 shows yet an alternative embodiment of the endoprosthesis 60. The shown endoprosthesis 60 is similar to the embodiment of FIG. 3. However, the fiber 1 forms a substantially closed loop 6 around the suture for a more secure attachment.
[0040] FIG. 5 shows a cross-sectional view of an endoprosthesis 60 in a plane that is arranged parallel to the stent structure 5. The suture 3 extends as a continuous loop-structure around and along the stent structure 5 and the graft 2 such as to fix both together. The suture 3 is configured as buttonhole stitch 7,7′,7″ and thus comprises a loop portion 7′, a knot portion 7, and a loop-connecting portion 7″. The loops 7′ of the buttonhole stitch extend around the graft 2 and the stent structure 5 and hold them together. The knot portions 7 form the loops 7′ which are connected to one another by the loop-connecting portions 7″. The suture 3 is made of conventional surgical thread without a substantial thrombogenic effect. The thrombogenic fiber 1 is made of polyamide, but may alternatively comprise or consist of polyethylene terephthalate, polypropylene, or polyglycoliclactic acid, and is attached to the loop-connecting portion 7″ of the buttonhole stitch. The fiber 1 forms a substantially closed loop 6 around the loop-connecting portions 7″ and is held there by friction between the suture 3 and the fiber 1. While not shown here, it would of course be possible to additionally use an adhesive, a heat treatment such as welding, or another additional attachment mechanism to create a more secure attachment. By contrast, if a high degree of flexibility is desired, the fiber 1 could also be attached by a loop 6 that is not closed in a similar fashion as shown in FIG. 3.
[0041] FIG. 6 shows an alternative embodiment of the endoprosthesis 60 similar to the embodiment shown in FIG. 5. In this embodiment, the fiber 1 forms a loop 6 that is not substantially closed as also shown in FIG. 3. Here the fiber 1 is attached to the suture in the loop 7′ of the buttonhole stitch 7,7′,7″.
[0042] FIG. 7a shows a cross-sectional view of a portion of an endoprosthesis 60 in a plane perpendicular to a longitudinal axis of the stent structure 5. The suture 3 is formed as a buttonhole stick and holds the stent structure 5 and the graft 2 together substantially as shown in FIGS. 5 and 6. Because the endoprosthesis 60 is shown in a cross-sectional view, only the first loop 7′ of the buttonhole stitch is visible. The fibers 1, only two of which are visible in the shown perspective, are attached to an additional support string 8 that extends in a substantially parallel manner along the stent structure 5 and through the loops 7′ of the buttonhole stitch. The support string 8 is therefore fixedly attached to the endoprosthesis 60 via the suture and the support string.
[0043] FIG. 7b shows the embodiment of FIG. 7a in a cross-sectional view in a plane that is arranged parallel to the stent structure 5. The support string 8 extends parallel to the stent structure 5 and is arranged within the loops 7′ of the buttonhole stitch 7,7′,7″. The fibers 1 extend away from the graft 2 and the stent structure 5 and are attached to the endoprosthesis 60 via the support string 8 and the suture 3.
[0044] FIG. 8 shows an exemplary endoprosthesis 60 according to the invention. The endoprosthesis 60 comprises a stent formed of a plurality of bars or stents 5 in a manner known in the art and a graft 2 which are attached to one another through a suture (not shown) to which fibers 1 are attached. At least one, and preferably several, fibers 1 are arranged on the endoprosthesis 60. The fibers 1 can be thrombogenic fibers for promoting thrombosis around or adjacent the endoprosthesis 60. The fibers 1 may have a portion (e.g. at least one end and/or or at least one intermediate portion) that is free to extend away from the graft and/or stent, for example, by at least a certain distance. The fibers 1 optionally may be distinct from the suture and/or from the graft.
[0045] Any of the above-mentioned attachment mechanisms is suitable to attach the fibers 1 to the endoprosthesis 60 (e.g. to the stent and/or graft). The fibers 1 may remain attached by the suture, to the stent and/or to the graft after implantation using these attachment mechanisms. In the present embodiment, all the fibers are attached by the same mechanism. However, it would also be conceivable to attach different fibers 1 with different mechanisms and thus include several of the above-described mechanisms in one endoprosthesis. In particular, fibers with varying lengths between 2 and 50 mm may be attached to the stent and/or graft by the above-described mechanisms. Additionally or alternatively, fibers 1 may be attached to the stent and/or graft by the above-described mechanisms such that a free portion of the fiber may have a length of, and/or be able to extend away from the stent and/or graft by a distance of, between 2 and 50 mm. Similarly, the present embodiment shows a plurality of fibers 1 attached on the endoprosthesis 60 with a substantially uniform distribution. The person skilled in the art will understand that this is merely an exemplary embodiment and that any number of fibers 1 could be attached to the endoprosthesis 60, or with any distribution desired for a particular application. The fibers are preferably attached to the endoprosthesis 60 by the method according to the invention.
