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

• US 20070043429A1
• Filed: 08/16/2006
• Published: 02/22/2007
• 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
• Granted Patent: US 8,475,519 B2
• Time in Patent Office: Days
• US Class Current: 623/1.150
• 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:

a marker element to increase the X-ray visibility which is at least partially insertable into a cut-out in an implant structure and has a coated material comprising at least two layers.

2. The bodily implant according to claim 1, further comprising an externally exposed area, wherein the at least two layers being part of the externally exposed area and being 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 has a cylindrical-like shape and 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, or both, using a laser, 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. A method for manufacturing a marker element from a coated material, the method comprising:

manufacturing a coated panel from a plurality of flat materials by performing a rolling, welding, or gluing process, or a combination thereof; and

manufacturing a marker element from the coated panel by performing a punching, laser cutting, or water cutting process, or a combination thereof.

11. The method of claim 10, wherein forming the coated panel further includes an electroplating process.

12. The method according to claim 10, wherein the marker element is shaped into a rivet in a subsequent shaping process.

13. A method for manufacturing a marker element from a coated material, the method comprising:

manufacturing a coated tube by drawing of a multilayer tube blank;

placing one of the tubes within another; and

joining the tubes by a gluing, welding, or drawing process.

14. The method according to claim 13, wherein the marker element is shaped into a rivet in a subsequent shaping process.

15. A method for manufacturing a bodily implant having a marker element that is visible to X-rays, the method comprising:

forming a cut-out in an implant structure;

manufacturing a coated panel from a plurality of flat materials by using a rolling, welding, gluing, or electroplating process, or a combination thereof;

manufacturing a marker element from the coated panel by using a punching, laser cutting, or water cutting process, or a combination thereof; and

pressing or riveting the marker element into the cut-out in the implant structure.

16. The method according to claim 15, wherein the marker element is additionally welded into the cut-out by use of a laser.

17. The method according to claim 16, wherein an outer layer of the coated material is produced from the same material as that of the implant structure, and the marker element is polished after insertion.

18. The method according to claim 15, wherein an outer layer of the coated material is produced from the same material as that of the implant structure, and the marker element is polished after insertion.