Process method for attaching radio opaque markers to shape memory stent

• US 20050172471A1
• Filed: 02/09/2004
• Published: 08/11/2005
• Est. Priority Date: 02/09/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Vietmeier, Kristopher Henry
• Granted Patent: US 7,243,408 B2
• Time in Patent Office: Days
• US Class Current: 29/447
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91508 the meander having a difference in amplitude along the band
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: Y10T 29/496 Multiperforated metal article making
• CPC Class Codes: Y10T 29/49865 by temperature differential [e.g., shrink fit]

Abstract

A process comprising the steps of providing a precursor for an implantable medical device, at least a portion of the precursor made of a shape memory material, the shape memory material having a receptacle for receiving a marker therein, the shape memory material having an austenitic and a martensitic phase; enlarging the receptacle while the shape memory material is in the martensitic phase; inserting a marker in the receptacle while the shape memory material is in the martensitic phase; and thereafter transforming the precursor to the austenitic phase.

Claims

1. A process comprising the steps of:

a) providing a precursor for an implantable medical device, at least a portion of the precursor made of a shape memory material, the shape memory material having a receptacle for receiving a marker therein, the shape memory material having an austenitic and a martensitic phase;

b) enlarging the receptacle while the shape memory material is in the martensitic phase;

c) inserting a marker in the receptacle while the shape memory material is in the martensitic phase; and

thereafter

d) transforming the precursor to the austenitic phase.

2. The process of claim 1, wherein the precursor is a stent precursor.

3. The process of claim 1, wherein the precursor is chosen from the group consisting of a stent-graft precursor, a distal protection filter precursor, an embolic coil precursor, a graft precursor, and a vena cava filter precursor.

4. The process of claim 2, the precursor having a plurality of receptacles for receiving a plurality of markers.

5. The process of claim 4, wherein heat is applied to the plurality of receptacles prior to transforming the precursor to the austenitic phase.

6. The process of claim 1, further comprising the step of post-processing the precursor to form an implantable device suitable for implantation in the body.

7. The process of claim 6, wherein the post-processing includes the step of polishing the precursor.

8. The process of claim 6, where the implantable device is a stent.

9. The process of claim 6, wherein the implantable device is chosen from the group consisting of a stent-graft, a distal protection filter, an embolic coil, a graft, and a vena cava filter.

10. The process of claim 1, wherein the shape memory material is nitinol.

11. The process of claim 2, wherein the shape memory material is nitinol.

12. The process of claim 1, wherein the implantable medical device is a stent, the stent having a first end and a second end, the receptacle being positioned at the first end of the stent.

13. The process of claim 1, wherein the implantable medical device is a stent, the stent having a first end and a second end, the receptacle being positioned between the first end of the stent and the second end of the stent.

14. The process of claim 1, wherein the implantable medical device is formed prior to the receptacle being enlarged.

15. The process of claim 1, wherein the implantable medical device and the receptacle are made from different materials.

16. The process of claim 1, wherein the marker is radiopaque.

17. A process comprising the steps of:

a) providing a precursor for an implantable medical device, at least a portion of the device made of a shape memory material, the shape memory material having a receptacle for receiving a marker therein, the shape memory material having at least a first phase and a second phase;

b) causing the shape memory material to transition from the first phase to the second phase;

b) enlarging the receptacle while the shape memory material is in the second phase;

c) inserting a marker in the receptacle while the shape memory material is in the second phase; and

thereafter

d) transforming the precursor to the first phase.

18. The process of claim 17, wherein the shape memory material is a metal.

19. The process of claim 18, wherein the metal is nitinol and the first phase is an austenitic phase and the second phase is a martensitic phase.

20. The process of claim 17, wherein the shape memory material is polymeric.

21. The process of claim 17, wherein the precursor is a stent precursor.

22. The process of claim 17, wherein the precursor is chosen from the group consisting of a stent-graft precursor, a distal protection filter precursor, an embolic coil precursor, a graft precursor, and a vena cava filter precursor.

23. The process of claim 21, the precursor having a plurality of receptacles for receiving a plurality of markers.

24. The process of claim 23, wherein heat is applied to the plurality of receptacles prior to transforming the precursor to the austenitic phase.

25. The process of claim 17, further comprising the step of post-processing the precursor to form an implantable device suitable for implantation in the body.

26. The process of claim 25, wherein the post-processing includes the step of polishing the precursor.

27. The process of claim 25, where the implantable device is a stent.

28. The process of claim 25, wherein the implantable device is chosen from the group consisting of a stent-graft, a distal protection filter, an embolic coil, a graft, and a vena cava filter.

29. The process of claim 17, wherein the shape memory material is nitinol.

30. The process of claim 21, wherein the shape memory material is nitinol.

31. The process of claim 17, wherein the implantable medical device is a stent, the stent having a first end and a second end, the receptacle being positioned at the first end of the stent.

32. The process of claim 17, wherein the implantable medical device is a stent, the stent having a first end and a second end, the receptacle being positioned between the first end of the stent and the second end of the stent.

33. The process of claim 17, wherein the implantable medical device is formed prior to the receptacle being enlarged.

34. The process of claim 17, wherein the implantable medical device and the receptacle are made from different materials.

35. The process of claim 17, wherein the marker is radiopaque.