ENDOPROSTHESIS AND METHOD FOR MANUFACTURING SAME

• US 20090030506A1
• Filed: 07/23/2008
• Published: 01/29/2009
• Est. Priority Date: 07/24/2007
• Status: Abandoned Application

• Current Assignee: Biotronik VI Patent AG (Biotronik SE & Company KG)
• Original Assignee: Biotronik VI Patent AG (Biotronik SE & Company KG)
• Inventors: Bayer, Ullrich, Klocke, Bjoern, Adden, Nina
• Application Number:
  US12/178,343
• Publication Number:
  US 20090030506A1
• Time in Patent Office: Days
• US Class Current: 623/1.460
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0031 made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
• CPC Class Codes: A61L 31/08 Materials for coatings
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body

Abstract

A stent with a basic mesh comprising an at least largely biodegradable material and a coating (30) arranged on the biodegradable material. The basic mesh is covered completely by a coating, except for at least one degradation area (23, 25, 32), whereby the at least one degradation area (23, 25, 32) is designed as a recess in the coating (30).

Claims

1. An endoprosthesis, in particular, an intraluminal endoprosthesis, comprising:

a basic mesh comprising an at least largely biodegradable material and a coating arranged on the biodegradable material, the coating being inert, and the basic mesh is covered completely by the coating except for at least one degradation area for targeted control of degradation in the degradation area, whereby the at least one degradation area comprises a recess in the inert coating.

2. The endoprosthesis of claim 1, wherein the inert coating is flexible.

3. The endoprosthesis of claim 1, wherein the inert coating comprises one or more compounds from the group consisting of polysulfone, silicone rubber, polyurethane, synthetic glycocalix, amorphous silicon carbide, diamond-like carbon (DLC), magnesium phosphate, magnesium oxide and mixtures of the foregoing.

4. The endoprothesis of claim 1, further comprising an adhesive layer arranged between either the inert coating or the coating that contains parylene and the material of the basic mesh, and wherein the adhesive layer contains one or more compounds from the group consisting of magnesium oxide, magnesium phosphate and inorganic magnesium compounds.

5. The endoprosthesis of claim 1, wherein the at least one degradation area comprises a plurality of degradation areas which are arranged only proximate to the connecting webs.

6. The endoprothesis of claim 1, the basic mesh further comprising at least one degradation element which protrudes away from the basic mesh, each degradation element having at least one degradation area, the degradation element having a finger shape and extending essentially in the area of the jacket volume formed by the basic mesh.

7. The endoprothesis of claim 6, wherein each degradation element has exactly one degradation area which is arranged on the end of the degradation element that protrudes away from the basic mesh.

8. The endoprothesis of claim 6, wherein each degradation element has a diameter of approximately 50 to approximately 200 μ

m and a length of up to approximately 0.3 mm.

9. The endoprothesis of claim 1, wherein the at least one degradation area comprises a ring-shaped recess which extends around either a supporting element or a connecting web and the at least one degradation area comprises either a circular or a polygonal recess in the coating.

10. The endoprothesis of claim 1, the basic mesh further comprising a plurality of supporting elements which run essentially in the circumferential direction and are arranged one after the other in the axial direction, with connecting webs that connect the individual supporting elements, whereby at least one degradation area is provided on a plurality of connecting webs arranged in a predetermined area of the endoprosthesis and on the degradation elements arranged on one of the connecting webs.

11. The endoprothesis of claim 1, wherein the biodegradable material comprises a material selected from the group consisting of Mg, Mg alloy, WE43, a biodegradable polymer, and PLLA.

12. The endoprothesis of claim 1, wherein the coating further comprises one or more polymers of the group consisting of polyesterspolylactides and polypeptides.

28. The endoprothesis of claim 6, wherein each degradation element has a diameter of approximately 50 to approximately 200 μ

m and a length of up to approximately 0.1 mm.

29. The endoprosthesis of claim 9, wherein the either circular or polygonal recess has a diameter of from approximately 1 to 10 μ

m.

13. An endoprothesis, in particular, an intraluminal endoprothesis having a basic mesh, comprising:

an at least mostly biodegradable material and a coating arranged on the biodegradable material, wherein the coating contains at least parylene and the basic mesh is completely covered by the coating except for at least one degradation area for targeted control of degradation in the degradation area, whereby the at least one degradation area comprises a recess in the coating containing parylene.

14. The endoprothesis of claim 13, wherein the layer thickness of the coating containing parylene in the areas which are different from the degradation areas is between approximately 0.1 μ

m and approximately 10 μ

m.

15. The endoprothesis of claim 13, further comprising an adhesive layer arranged between the inert coating or the coating that contains parylene and the material of the basic mesh, the adhesive layer containing one or more compounds from the group consisting of magnesium oxide, magnesium phosphate and inorganic magnesium compounds.

16. The endoprosthesis of claim 13, wherein a plurality of degradation areas is arranged only in the area of the connecting webs.

17. The endoprothesis of claim 13, the basic mesh further comprising at least one degradation element which protrudes away from the basic mesh each degradation area having at least one degradation area, the degradation element having a finger shape and extending essentially in the area of the jacket volume formed by the basic mesh.

18. The endoprothesis of claim 13, wherein each degradation element has exactly one degradation area which is arranged on the end of the degradation element that protrudes away from the basic mesh.

19. The endoprothesis of claim 13, wherein the degradation element has a diameter of approximately 50 to approximately 200 μ

m and the degradation element has a length of up to approximately 0.3 mm.

20. The endoprothesis of claim 13, wherein the at least one degradation area has a ring-shaped recess which extends around either a supporting element or a connecting web and the at least one degradation area has either a circular or a polygonal recess in the coating.

21. The endoprothesis of claim 13, the basic mesh further comprising supporting elements which run essentially in the circumferential direction and are arranged one after the other in the axial direction, with connecting webs that connect the individual supporting elements, whereby at least one degradation area is provided on a plurality of connecting webs arranged in a predetermined area of the endoprosthesis and on the degradation elements arranged on one of these connecting webs.

22. The endoprothesis of claim 13, wherein the biodegradable material contains a material selected from the group consisting of Mg, Mg alloy, WE43, a biodegradable polymer, and PLLA.

23. The endoprothesis of claim 13, wherein the coating contains at least one polymer from the group consisting of polyesters, polylactides and polypeptides.

30. The endoprothesis of claim 13, wherein the layer thickness of the coating containing parylene in the areas which are different from the degradation areas is between approximately 0.4 μ

m and approximately 7 μ

m.

31. The endoprothesis of claim 13, wherein the layer thickness of the coating containing parylene in the areas which are different from the degradation areas is between approximately 1 μ

m and approximately 5 μ

m.

32. The endoprothesis of claim 19, wherein each degradation element has a diameter of approximately 50 to approximately 200 μ

m and a length of up to approximately 0.1 mm.

33. The endoprosthesis of claim 20, wherein the either circular or polygonal recess has a diameter of from approximately 1 to 10 μ

m.

24. A method for manufacturing an endoprosthesis, comprising:

a) providing the basic mesh of the endoprothesis with degradation elements;

b) applying a coating containing at least parylene to the surface of the endoprosthesis so that it is completely covered; and

c) treating the coating with oxygen plasma.

25. The method of claim 24, wherein the coating containing parylene is approximately 0.1 μ

m to approximately 10 μ

m thick is applied.

26. The method of claim 24, wherein the coating containing parylene is approximately 0.4 μ

m to approximately 7 μ

m thick.

27. The method of claim 24, wherein the coating containing parylene is approximately 1 μ

m to approximately 5 μ

m thick.