EXTERNAL STENT

• US 20110230955A1
• Filed: 11/24/2009
• Published: 09/22/2011
• Est. Priority Date: 11/24/2008
• Status: Active Grant

• Current Assignee: The Medical Research, Infrastructure And Health Services Fund Of The Tel Aviv Medical Center, Vascular Graft Solutions Ltd.
• Original Assignee: The Medical Research, Infrastructure And Health Services Fund Of The Tel Aviv Medical Center, Vascular Graft Solutions Ltd.
• Inventors: Rapaport, Avraham, Winshtein, Ronny, Cibulski, Gilad, Ben-Gal, Yanai, Orion, Eyal, Bachar, Yehuda
• Granted Patent: US 8,734,503 B2
• Time in Patent Office: Days
• US Class Current: 623/1.15
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure

Abstract

An external vein support comprising an elongate axial body including an axis, said body is plastically deformable by at least one of stretching, bending, twisting, and any combination thereof, relative to said axis.

Claims

1. An external vein support comprising an elongate axial body including an axis, said body is plastically deformable by at least one of:

stretching, bending, twisting, and any combination thereof, relative to said axis.

2. An external vein support according to claim 1 wherein said body is fixedly deformable in diameter at a plurality of points along a length of the body.

3. An external vein support according to claim 2 wherein said body is radially elastic in at least one point of the plurality of points fixedly deformed.

4. An external vein support according to claim 1 wherein said body comprises a substantially non-uniform diameter.

5. An external vein support according to claim 1 wherein said body comprises a plurality of fibers arranged so that at a first average diameter, the resilience of said body relative to said axis is substantially greater than at a second average diameter.

6. An external vein support according to claim 5 wherein said axis is a longitudinal axis of said axial body.

7. An external vein support according to claim 5 wherein said axis is a transverse axis of said axial body.

8. An external vein support according to claim 6, wherein a reduction of the diameter decreases said resilience.

9. An external vein support according to claim 7, wherein a reduction of the diameter increases said resilience.

10. An external vein support according to claim 1 wherein said body comprises a plurality of fibers arranged so that the support is radially elastic having previously been fixedly deformed.

11. An external vein support according to claim 1 wherein said body comprises at least one plastically deformable element.

12. An external vein support according to claim 10 wherein the plastically deformable element is a plastically deformable fiber.

13. An external vein support according to claim 12 wherein the at least one plastically deformable fiber is spirally interlaced along the body.

14. An external vein support according to claim 1 wherein said body comprises a plurality of non-plastically deformable elements.

15. An external vein support according to claim 14 wherein at least one of said non-plastically deformable elements is an elastic fiber.

16. An external vein support according to claim 1 further comprising an extension attachable to an end portion of said body.

17. The extension of claim 16 comprising a first opening and a second opening, the second opening skewed relative to the first opening and forming an angle ø

between 20 and 80 degrees relative to said axis.

18. An external vein support according to claim 1 wherein an end portion of said body is elastically deformable longitudinally along said axis.

19. An external vein support according to claim 1 wherein said axial body is manipulatable from a pre-deformation relaxed length to a post-deformation relaxed length different than the pre-deformation relaxed length.

20. An external vein support according to claim 19 wherein said post-deformation relaxed length is greater than said pre-deformation relaxed length.

21. An external vein support according to claim 19 wherein said post-deformation relaxed length is smaller than said pre-deformation relaxed length.

22. An external vein support according to claim 19 wherein said post-deformation relaxed length is equal to the length of said graft.

23. An external vein support according to claim 19 wherein said axial body is tubular when in said pre-deformation relaxed length.

24. An external vein support according to claim 19 wherein said axial body is in the form of a truncated cone when in said post-deformation relaxed length.

25. An external vein support according to claim 19 wherein said axial body is tubular when in said post-deformation relaxed length.

26. An external vein support according to claim 19 configured to form a composite graft using natural cell growth through a periphery of said axial body when in said post-deformation relaxed length.

27. An external vein support according to claim 26 wherein said vein support is capable of resilient radial expansion in a manner providing compliance in the range of 3-30%/100 mm Hg.

28. An external vein support according to claim 26 wherein said vein support is capable of resilient radial expansion in a manner providing compliance less than 5%/100 mm Hg.

29. An external vein support according to claim 19 wherein said axial body is further manipulatable to a chosen substantially non-linear contoured path.

36. An external vein support according to claim 1 wherein said body includes at least two plastically deformable elements intersecting to form a braiding angle, wherein a plasticity of said support increases along a longitudinal axis as said angle decreases from a larger angle in a support first less extended position, to a smaller angle in a support second more extended position.

37. The support of claim 36 wherein the braiding angle is between 30 degrees and 150 degrees, inclusively.

44. An external vein support according to claim 1, wherein said elongate body has a first end and a second end with a channel therebetween, the elongate body having a relaxed pre-deformation configuration, the channel sized to freely receive the vein when the body is in the pre-deformation configuration so that an axis of the channel extends along an axis of the vein;

the body being manually manipulatable from the pre-deformation configuration to a relaxed post-deformation configuration selected in response to the vascular system, the channel in the post-deformation configuration supporting receiving the vein therein so as to inhibit tissue-response induced occlusion of the desired flow.

45. An external vein support according to claim 1, wherein said vein support is adapted for mounting on and conforming to a vein in-situ and in-vivo without requiring the fixing of said external support to said vein along said vein.

30. A method of mounting a vein, comprising:

attaching a vein to at least two separate points in a vascular system;

allowing blood to flow in and expand said vein; and

shaping a vein support element mounted on the vein during said flowing.

31. A method according to claim 30 wherein shaping said vein support comprises plastically deforming the body by stretching the support along an axis.

32. A method according to claim 30 wherein shaping said vein support comprises plastically deforming the body by compressing the support along the axis.

33. A method according to claim 30 wherein shaping said vein support comprises plastically deforming the body by axially bending the support.

34. A method according to claim 30 comprising including a radially elastic portion along a length of the body.

35. A method according to claim 30 comprising decreasing springback by reducing the diameter.

38. A method for providing a desired blood flow between a first point in a vascular system of a patient and a second point in the vascular system, the method comprising:

providing a vein having a first end;

attaching the first end of the vein to the first point in the vascular system with a first anastomosis so as to incorporate the vein into the vascular system;

positioning the vein within a lumen of a vein support;

deforming the vein support in response to the vascular system so that a lumen of the vein is selectively reshaped to provide the desired bloodflow.

39. The method of claim 38 wherein the vein support is deformed by manipulating the vein support sufficiently to impose a plastic deformation of the vein support that alters a length of the vein support from a pre-deformation relaxed length to a post-deformation relaxed length different than the pre-deformation relaxed length, and wherein the manipulation of the vein support is performed while the vein is disposed in the vein support.

40. The method of claim 39, wherein the length of the vein support is coupled to a cross-sectional diameter of the vein support so that the plastic deformation alters the diameter from a pre-deformation relaxed diameter to a post-deformation relaxed diameter different than the pre-deformation relaxed diameter, and wherein the post-deformation diameter is selected in response to a diameter of the vein.

41. The method of claim 40, wherein the vein has the vein diameter at a first axial location of the vein and another vein diameter at a second axial location of the vein, wherein the manipulation of the vein support is performed so that the vein support has the vein support diameter adjacent the first axial location and a second vein support diameter corresponding to the second vein diameter adjacent the second axial location.

42. The method of claim 38, wherein the vein support is deformed by manipulating the vein support sufficiently to impose a plastic deformation of the vein support that alters a path of the lumen between the first point and the second point from a first relaxed axial path to a second relaxed axial path, the second path defining a different angle relative to the adjacent vascular system at the first point than the first path so that laminar flow through the vein is promoted by the manipulation of the vein support, and wherein the manipulation of the vein support is performed while the vein is disposed in the vein support.

43. The method of claim 38, wherein the vein support responds elastically to physiological stress associated with the bloodflow, and wherein the vein support responds plastically to manually imposed stress associat ed with the deforming of the vein support, the response of the vein support differing significantly from a compliance of natural arteries of the vascular system.