X-ray visibility and corrosion resistance of niti stents using markers made of sandwich material

• US 8,475,519 B2
• Filed: 08/16/2006
• Issued: 07/02/2013
• Est. Priority Date: 08/18/2005
• Status: Active Grant

• Current Assignee: ADMEDES Schuessler GmbH
• Original Assignee: ADMEDES Schuessler GmbH
• Inventors: Hegel, Alexander, Steegmuller, Rainer, Schrader, Bernd
• Primary Examiner(s): CHAO, ELMER M
• Application Number:
  US11/505,625
• Publication Number:
  US 20070043429A1
• Time in Patent Office: 2,512 Days
• Field of Search: 623/11, 623/1, 623/12, 623/1.34, 623/1.1, 623/1.15
• US Class Current: 623/1.34
• 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 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: Y10T 83/0405 With preparatory or simultaneous ancillary treatment of work

Abstract

A bodily implant, in particular a stent, for insertion or implantation into a living body, having a marker element for increasing X-ray visibility, which is at least partially insertable into a cut-out in an implant structure and which has a coated material comprising at least two layers. A corresponding method for manufacturing a marker element from a coated material, and a corresponding method for manufacturing a bodily implant, in particular a stent, having a marker element which is visible to X-rays, is disclosed.

Claims

1. A bodily implant for insertion into a living body, the bodily implant comprising:

an implant structure having a cut-out formed therein; and

a marker element to increase the X-ray visibility which is at least partially insertable into the cut-out in the implant structure,

wherein the marker element has a coated material comprising at least two layers that are each made of a material that is different than that of the implant structure and that are each tapered such that the marker element is cone-shaped, and

wherein the first layer and the second layer each have side surfaces that contact the implant structure, the first layer and the second layer each have top and bottom surfaces, and the entire side surfaces of the first layer and the second layer are each tapered along a plane extending from the top surface of the second layer to the bottom surface of the first layer.

2. The bodily implant according to claim 1, further comprising an externally exposed area, wherein the at least two layers are part of the externally exposed area and are resistant to corrosion.

3. The bodily implant according to claim 1, wherein the coated material of the marker element has two outer layers and at least one inner layer between them, the outer layers comprising a corrosion-resistant material and the inner layer comprising a material with good X-ray visibility.

4. The bodily implant according to claim 1, wherein the marker element is designed as a rivet which is at least partially insertable into a corresponding cut-out in the bodily implant.

5. The bodily implant according to claim 4, wherein the marker element designed as a rivet is pressed or is welded using a laser, or both, into the cut-out in the bodily implant.

6. The bodily implant according to claim 1, wherein an inner layer of the coated material is encapsulated in such a way that the inner layer has no contact with the material of the bodily implant or no contact with the bloodstream in the bodily vessel, or both.

7. The bodily implant according to claim 3, wherein the inner layer includes gold or a gold alloy.

8. The bodily implant according to claim 3, wherein the outer layers include tantalum or nitinol, or both.

9. The bodily implant according to claim 1, wherein the bodily implant is a stent.

10. The bodily implant according to claim 3, wherein the two outer layers are formed independent of the at least one inner layer.

11. The bodily implant according to claim 3, wherein each of the two outer layers and the at least one inner layer has tapered edges such that the marker element is cone-shaped.

12. The bodily implant according to claim 3, further comprising a protective layer provided between the at least one inner layer and an interface with the bodily implant.

13. The bodily implant according to claim 12, wherein the protective layer functions to reduce a gap between the marker element and the bodily implant.

14. The bodily implant according to claim 1, further including at least one weld seam located at each of an inner circumference and an outer circumference of the marker element.

15. A bodily implant, comprising:

an implant structure having a cut-out formed therein; and

a marker element which is at least partially insertable into the cut-out in the implant structure, the marker element including a first layer and a second layer,

wherein the first layer has an X-ray visibility greater than an X-ray visibility of the second layer,

wherein the first layer and the second layer are each made of a material that is different than that of the implant structure and are each tapered such that the marker element is cone-shaped, and

wherein the first layer and the second layer each have side surfaces that contact the implant structure, the first layer and the second layer each have top and bottom surfaces, and the entire side surfaces of the first layer and the second layer are each tapered along a plane extending from the top surface of the second layer to the bottom surface of the first layer.

16. The bodily implant according to claim 15, wherein the first layer and the second layer are formed independent of the implant structure.

17. The bodily implant according to claim 15, wherein the second layer at least partially encapsulates the first layer.

18. The bodily implant according to claim 15, wherein each of the first layer and the second layer has a uniform thickness.

19. The bodily implant according to claim 18, wherein the thickness of the first layer is greater than the thickness of the second layer.

20. The bodily implant according to 19, wherein the marker element further includes a third layer, the first layer is disposed between the second layer and the third layer, and the third layer has the same thickness as the second layer.

21. The bodily implant according to claim 15, wherein the implant structure includes a top surface and a bottom surface, the cut-out extends from the top surface of the implant structure to the bottom surface of the implant structure, the cut-out is formed with angled surfaces relative to a plane bisecting the cut-out such that inner surfaces of the implant structure that extend from the top surface of the implant structure to the bottom surface of the implant structure and form the cut-out angle towards the plane when extending from the top surface of the implant structure to the bottom surface of the implant structure.

22. The bodily implant according to claim 21, wherein the side surfaces of the first layer and the second layer are each tapered at the same angle as the inner surfaces of the implant structure.

23. The bodily implant according to claim 21, wherein the marker element includes a third layer having a top surface and a bottom surface, the first layer is arranged between the second layer and the third layer, the bottom surface of the second layer contacts the top surface of the first layer, and the bottom surface of the first layer contacts the top surface of the third layer.

24. The bodily implant according to claim 23, wherein the marker element is shaped such that when the marker element is fully inserted into the cut-out in the implant structure, the top surface of the second layer is flush with the top surface of the implant structure and the bottom surface of the third layer is flush with the bottom surface of the implant structure.

25. The bodily implant according to claim 23, wherein the third layer further includes side surfaces, and the side surfaces of the first layer, the second layer, and the third layer are each tapered at the same angle as the inner surfaces of the implant structure.

26. The bodily implant according to claim 15, wherein the implant structure includes a top surface and a bottom surface, the cut-out extends only partially from the top surface of the implant structure to the bottom surface of the implant structure, the cut-out is formed with angled surfaces relative to a plane bisecting the cut-out such that inner surfaces of the implant structure that extend from the top surface of the implant structure to the bottom surface of the implant structure and form the cut-out angle towards the plane when extending from the top surface of the implant structure to the bottom surface of the implant structure.

27. The bodily implant according to claim 26, wherein the side surfaces of the first layer and the second layer are each tapered at the same angle as the inner surfaces of the implant structure.

28. The bodily implant according to claim 26, wherein the marker element is shaped such that when the marker element is fully inserted into the cut-out in the implant structure, the top surface of the first layer is flush with the top surface of the implant structure and the second layer is fully encapsulated by the first layer and the marker element.

29. A bodily implant, comprising:

an implant structure having a cut-out formed therein; and

a marker element to increase X-ray visibility which is at least partially insertable into the cut-out in the implant structure, the marker element including a first layer and a second layer,

wherein the first layer and the second layer are each tapered such that the marker element is cone-shaped, and

wherein the first layer and the second layer each have side surfaces that contact the implant structure, the first layer and the second layer each have top and bottom surfaces, and the entire side surfaces of the first layer and the second layer are each tapered along a plane extending from the top surface of the second layer to the bottom surface of the first layer.

30. The bodily implant according to claim 29, wherein the marker element further includes a third layer having a top surface and a bottom surface, the first layer being arranged between the second layer and the third layer such that the top surface of the first layer is in contact with the bottom surface of the second layer and the bottom surface of the first layer is in contact with the top surface of the third layer.

31. The bodily implant according to claim 30, wherein the third layer further has side surfaces, the plane extends from the top surface of the second layer through the bottom surface of the first layer to the bottom surface of the third layer, and the entire side surfaces of the first layer, the second layer, and the third layer are each tapered along the plane extending from the top surface of the second layer through the bottom surface of the first layer to the bottom surface of the third layer.

32. The bodily implant according to claim 31, further comprising at least one protective layer arranged between the implant structure and the side surfaces of each of the first layer, the second layer, and the third layer.

33. The bodily implant according to claim 30, wherein the first layer, the second layer, and the third layer are all curved relative to the plane extending from the top surface of the second layer to the bottom surface of the first layer.

34. The bodily implant according to claim 33, wherein the curvature of the first layer is the same as the curvature of the second layer which is the same as the curvature of the third layer.

35. The bodily implant according to claim 33, wherein a portion of the implant structure for receiving the marker element is curved and has a curvature equal to the curvature of the first layer, the second layer, and the third layer.

36. The bodily implant according to claim 29, wherein the first layer and the second layer are both curved relative to the plane extending from the top surface of the second layer to the bottom surface of the first layer.

37. The bodily implant according to claim 36, wherein the curvature of the first layer is the same as the curvature of the second layer.

38. The bodily implant according to claim 36, wherein the first layer has a uniform thickness, the second layer has a uniform thickness, and the uniform thickness of the first layer is greater than the uniform thickness of the second layer.

39. The bodily implant according to claim 36, wherein a portion of the implant structure for receiving the marker element is curved and has a curvature equal to the curvature of the first layer and the second layer.

40. The bodily implant according to claim 39, wherein the marker element and the cut-out are sized and shaped such that when the marker element is fully inserted into the implant structure, the top surface of the second layer is flush with a top surface of the implant structure.

41. The bodily implant according to claim 40, wherein the marker element and the cut-out are further sized and shaped such that when the marker element is fully inserted into the implant structure, the first layer is fully encapsulated by the second layer and the implant structure.