Stents with temporary retaining bands

• US 6,350,277 B1
• Filed: 01/15/1999
• Issued: 02/26/2002
• Est. Priority Date: 01/15/1999
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Kocur, Gordon J.
• Primary Examiner(s): O'Connor, Cary E.
• Application Number:
  US09/232,404
• Time in Patent Office: 1,138 Days
• Field of Search: 623/1.32, 623/1.38, 623/1.23, 623/1.12, 623/1.15, 623/1, 623/1.11, 606/194-195, 156/196
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/90 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• 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 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0071 breakable or frangible

Abstract

A self-expanding stent is formed of a stent framework and retaining segments disposed about the framework. The retaining segments hold the stent in a partially or fully contracted state in a bodily vessel. The retaining segments are constructed to fail after a predetermined time or upon the application of a predetermined force. Upon failure of the segments, the stent expands in the bodily vessel.

Claims

1. An expandable stent for use in a body lumen comprising:

an expandable stent framework, the stent framework expandable from a reduced diameter configuration to a fully expanded configuration;

and at least one stent retaining segment disposed about the stent framework, the stent retaining segment formed of at least one segment of material which is non-degradable in the body and at least one segment of degradable material joined together and constructed and arranged to fail upon degradation of at least a portion of the stent retaining segment,

the stent retaining segment maintaining the stent framework in a less than fully expanded configuration prior to failure of the stent retaining segment.

2. The stent of claim 1 comprising a plurality of stent retaining segments.

3. The stent of claim 1 wherein the retaining segment comprises a plurality of alternating segments which are non-degradable in the body and biodegradable segments joined together.

4. The stent of claim 1 wherein the stent framework comprises a plurality of interconnected struts and the retaining segment connects no more than two adjacent struts.

5. The stent of claim 1 wherein the retaining segment is in the form of a web.

6. The stent of claim 1 wherein the at least one stent retaining segment maintains at least a portion of the stent framework in a less than fully expanded configuration of reduced diameter.

7. The stent of claim 1 wherein the at least one stent retaining segment maintains at least a portion of the stent framework in a less than fully expanded configuration of reduced cross-section.

8. An expandable stent comprising:

an expandable stent framework, the stent framework expandable from a reduced diameter configuration to an initially deployed diameter configuration and being further expandable to a fully expanded configuration;

and at least one stent retaining segment disposed about the stent framework, the stent retaining segment constructed to fail in the body by erosion, the stent retaining segment maintaining the stent framework in the initially deployed diameter configuration, the stent retaining segment provided with one or more weakened regions to facilitate failure of the stent retaining segment.

9. The stent of claim 8 wherein the stent retaining segment is constructed to fail after a predetermined amount of time in a bodily lumen as a result of degradation over the predetermined period of time.

10. The stent of claim 8 wherein the retaining segment is constructed to fail after at least one month in a human bodily lumen as a result of degradation.

11. The stent of claim 8 where the stent retaining segment is constructed to fail upon the application thereto of a predetermined force.

12. The stent of claim 8 wherein the at least one stent retaining segment maintains at least a portion of the stent framework in a less than fully expanded configuration of reduced diameter.

13. The stent of claim 8 wherein the at least one stent retaining segment maintains at least a portion of the stent framework in a less than fully expanded configuration of reduced cross-section.

14. An expandable stent comprising:

an expandable stent framework, the stent framework expandable from a reduced diameter configuration to an initially deployed diameter configuration and being further expandable to a fully expanded configuration;

and at least one stent retaining segment made from a material disposed about the stent framework, the stent retaining segment maintaining the stent framework in the initially deployed diameter configuration, the stent retaining segment constructed and arranged to have at least one fatigue point thereon, the stent retaining segment narrowing at the fatigue point, the stent retaining segment constructed and arranged to fail by erosion of the at least one fatigue point.

15. The stent of claim 14, wherein the stent retaining segment is made of a biodegradable material.

16. The stent of claim 15 wherein the biodegradable material is provided with a treatment agent.

17. The stent of claim 14 wherein the stent retaining segment is provided with a treatment agent.

18. The stent of claim 14 wherein the stent retaining segment is disposed on the outside of the stent framework.

19. The stent of claim 14 wherein stent the retaining segment is interwoven through the stent framework.

20. The stent of claim 14 wherein the stent retaining segment is constructed to fail after a predetermined period of time in the body.

21. The stent of claim 20 wherein the period of time is at least one month.

22. The stent of claim 20 wherein the retaining segment is in the form of a band disposed about the stent framework.

23. The stent of claim 14 the retaining segment having a plurality of fatigue points thereon.

24. The stent of claim 14 wherein the retaining segment is made of an inert material.

25. The stent of claim 24 wherein the material is PTFE.

26. A treatment method comprising the steps of:

i) implanting an expandable prosthesis in a bodily lumen, the expandable prosthesis comprising

1) an expandable prosthesis framework, the prosthesis framework expandable from a reduced diameter configuration to a fully expanded configuration; and

2) a prosthesis retaining segment which is constructed to fail upon dissolution of at least a portion thereof, the prosthesis retaining segment formed at least in part of a biodegradable material joined to a material which is non-degradable in the body,

the prosthesis retaining segment disposed about the prosthesis and maintaining the prosthesis framework in a reduced diameter configuration.

27. The method of claim 26 wherein the prosthesis retaining segment is constructed to fail after a predetermined time in a bodily lumen.

28. The method of claim 26 wherein the predetermined time is at least one month.

29. A treatment method comprising the steps of:

implanting an expandable prosthesis in a bodily lumen, the expandable prosthesis comprising

1) an expandable prosthesis framework, the prosthesis framework expandable from a reduced diameter configuration to an initially deployed diameter configuration and being further expandable to a fully expanded configuration; and

2) a prosthesis retaining segment which is constructed to have at least one weakened point thereon to facilitate failure of the segment under a predetermined set of conditions,

the prosthesis retaining segment disposed about the prosthesis and maintaining the prosthesis framework in the initially deployed diameter.

30. An expandable medical endoprosthesis for implantation in a bodily vessel comprising:

an expandable endoprosthesis framework expandable from a reduced diameter configuration to a fully expanded configuration;

and at least one degradable endoprosthesis retaining structure disposed about the endoprosthesis framework, the endoprosthesis retaining structure formed of at least one segment of material which is non-degradable in the body and at least one segment of degradable material joined together and constructed and arranged to fail upon degradation of at least a portion of the endoprosthesis retaining structure,

the endoprosthesis retaining structure maintaining the endoprosthesis framework in a reduced diameter configuration prior to failure of the endoprosthesis retaining structure.

31. The endoprosthesis of claim 30 wherein the retaining structure is in the form of a segment disposed about a circumference of the stent.

32. The endoprosthesis of claim 30 wherein the retaining structure is in the form of a web.