Stent delivery apparatus and method

• US 6,562,063 B1
• Filed: 11/30/1999
• Issued: 05/13/2003
• Est. Priority Date: 10/22/1993
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Shoemaker, Susan M., Euteneuer, Charles L., Peterson, Dean A., Burmeister, Paul H, Fraser, Phlayne M., Buirge, Andrew W.
• Primary Examiner(s): Lewis; Kim M.
• Application Number:
  US09/451,405
• Time in Patent Office: 1,260 Days
• Field of Search: 606/1,108,194,195,198 623/1,1.11,1.12,1.13,1.2
• US Class Current: 623/1.12
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/9662 the middle portion of the stent or stent-graft is released first
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A constrained stet has a plurality of stent retaining bands disposed about the stent which maintains the stent in a reduced diameter configuration. The stent is capable of being expanded from a reduced diameter configuration to a fully expanded configuration.

Claims

1. A constrained stent comprising:

a stent expandable from a reduced diameter configuration to a fully expanded configuration, the stent having an outer surface and an inner surface;

a plurality of stent retaining bands disposed about the stent, each retaining band having an inner surface and an outer surface, the inner surface of the band disposed against the outer surface of the stent, the stent retaining bands maintaining the stent in the reduced diameter configuration.

2. The constrained stent of claim 1 wherein the retaining bands are constructed and arranged so as to release the stent in a predetermined sequence.

3. The constrained stent of claim 2 wherein the stent has a proximal portion, a distal portion and a middle portion disposed between the proximal and distal portions, and the retaining bands are constructed and arranged to release the middle portion of the stent before the proximal and distal portions of the stent.

4. The constrained stent of claim 2 wherein the plurality of retaining bands includes bands of different thicknesses.

5. The constrained stent of claim 2 wherein the plurality of retaining bands includes bands of different compositions.

6. The constrained stent of claim 1 wherein the stent is self expanding.

7. The constrained stent of claim 1 wherein the stent is a balloon assisted expanding stent.

8. The constrained stent of claim 1 further comprising a sleeve disposed about the exterior of the stent.

9. The constrained stent of claim 1 further comprising a liner disposed about the interior of the stent.

10. The constrained stent of claim 1 wherein the retaining bands are a disposed about the exterior of the stent.

11. A constrained stent comprising:

a stent expandable from a reduced diameter configuration to a fully expanded configuration, the stent having an outer surface and an inner surface;

and at least one stent retaining band disposed about the stent, the retaining band having an inner surface and an outer surface, the inner surface of the band disposed against the outer surface of the stent, the stent retaining band maintaining the stent in the reduced diameter configuration wherein the stent retaining band is made of a water soluble material selected from the group consisting of PEO, PVP, PVA, mannitol and complex carbohydrates.

12. A constrained stent comprising:

a stent expandable from a reduced diameter configuration to a fully expanded configuration;

and at least one stent retaining band disposed about the stent, the stent retaining band maintaining the stent in the reduced diameter configuration wherein the at least one retaining band has perforations therein.

13. The constrained stent of claim 12 wherein the density of perforations on the retaining band is varied along the retaining band in a predetermined way.

14. A constrained stent comprising:

a stent expandable from a reduced diameter configuration to a fully expanded configuration, the stent having an outer surface and an inner surface;

and at least one stent retaining band disposed about the stent, the retaining band having an inner surface and an outer surface, the inner surface of the band disposed against the outer surface of the stent, the stent retaining band maintaining the stent in the reduced diameter configuration wherein the composition of the band is varied in predetermined sections.

15. A constrained stent comprising:

a stent expandable from a reduced diameter configuration to a fully expanded configuration;

a plurality of stent retaining bands disposed about the stent, the stent retaining bands maintaining the stent in the reduced diameter configuration wherein the thickness of the retaining bands is varied in predetermined sections of the bands.

16. A constrained stent comprising:

a stent expandable from a reduced diameter configuration to a fully expanded configuration, the stent having an outer surface and an inner surface;

and at least one stent retaining band disposed about the stent, the retaining band having an inner surface and an outer surface, the inner surface of the band disposed against the outer surface of the stent, the stent retaining band maintaining the stent in the reduced diameter configuration, the band constructed and arranged so as to allow for a controlled expansion of the stent wherein desired portions of the stent are released to expand in a desired sequence.

17. The constrained stent of claim 16 wherein the stent has a proximal portion, a distal portion and a middle portion disposed between the proximal and distal portions, the retaining band constructed and arranged to release the middle portion of the stent before the proximal and distal portions of the stent.

18. A constrained stent-graft comprising:

a stent-graft expandable from a reduced diameter configuration to a fully expanded configuration, the stent-graft having an outer surface and an inner surface;

and at least one stent-graft retaining band disposed about the stent-graft, the retaining band having an inner surface and an outer surface, the inner surface of the band disposed against the outer surface of the stent,-graft, the stent-graft retaining band maintaining the stent-graft in the reduced diameter configuration.

19. The constrained stent-graft of claim 18 comprising a sleeve comprised of collagen.

20. The constrained stent-graft of claim 19 wherein the collagen is carried on a support.

21. The constrained stent-graft of claim 20 wherein the support is a woven or braided fabric.

22. The constrained stent-graft of claim 20 wherein the support is made from a material selected from the group consisting of polyester, polyethylene, polyurethane and PTFE.

23. A prosthesis comprising:

an expandable prosthesis expandable from a reduced diameter configuration to a fully expanded configuration, the expandable prosthesis having an outer surface and an inner surface, the expandable prosthesis characterized by a length;

and at least one prosthesis retaining band disposed about the expandable prosthesis, the retaining band having an inner surface and an outer surface, the inner surface of the band disposed against the outer surface of the prosthesis, the prosthesis retaining band characterized by a length, wherein the length of the prosthesis retaining band is less than the length of the expandable prosthesis.

24. The prosthesis of claim 23 wherein the expandable prosthesis is selected from the group consisting of self-expanding stents, balloon expandable stents, non-self expanding stents, grafts and stent grafts.

25. The prosthesis of claim 23 where the expandable prosthesis is a stent made from a material selected from the group consisting of resilient metals, deformable metals, shape memory metals and plastic.

26. The prosthesis of claim 23 wherein the retaining band maintains the expandable prosthesis in a partially expanded configuration.

27. The prosthesis of claim 23 wherein the retaining band is attached to the expandable prosthesis.

28. A constrained prosthesis comprising:

a prosthesis expandable from a reduced diameter configuration to a fully expanded configuration, the prosthesis having an outer surface and an inner surface,;

a plurality of prosthesis retaining bands disposed about the prosthesis, each retaining band having an inner surface and an outer surface, the inner surface of the band disposed against the outer surface of the prosthesis, the prosthesis retaining bands maintaining the prosthesis in the reduced diameter configuration.

29. The constrained prosthesis of claim 28 wherein the prosthesis retaining bands are made of a water soluble material.

30. The constrained prosthesis of claim 28, the prosthesis having a proximal portion, a distal portion and a medial portion disposed between the proximal portion and the distal portion and the plurality of prosthesis retaining bands including a proximal retaining band disposed about the proximal portion of the prosthesis, a distal retaining band disposed about the distal portion of the prosthesis and a medial retaining band disposed about the medial portion of the prosthesis, wherein the medial retaining band is constructed and arranged to release sooner than the proximal and distal retaining bands in a bodily vessel.

31. The constrained prosthesis of claim 30 wherein the medial retaining band is made of a composition of lower molecular weight the proximal and distal retaining bands.

32. The constrained prosthesis of claim 30 wherein the medial retaining band is thinner than the proximal retaining band and the distal retaining band.

33. The constrained prosthesis of claim 30 wherein the density of perforations in the medial retaining band exceeds the density of perforations in the proximal retaining band and in the distal retaining band.

34. The constrained prosthesis of claim 28, the prosthesis having a proximal portion, a distal portion and a medial portion disposed between the proximal portion and the distal portion and the plurality of prosthesis retaining bands including a proximal retaining band disposed about the proximal portion of the prosthesis, a distal retaining band disposed about the distal portion of the prosthesis and a medial retaining band disposed about the medial portion of the prosthesis, wherein at least one of the proximal and distal retaining bands is constructed and arranged to release sooner than the medial retaining and in a bodily vessel.

35. The constrained prosthesis of claim 28, wherein at least some of the retaining band are constructed and arranged to release sooner than other of the retaining bands.