Self-expanding stent delivery system with two sheaths

• US 6,254,609 B1
• Filed: 01/11/1999
• Issued: 07/03/2001
• Est. Priority Date: 01/11/1999
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Sogard, David J., Vrba, Anthony C.
• Primary Examiner(s): Smith, Jeffrey A.
• Application Number:
  US09/228,097
• Time in Patent Office: 904 Days
• Field of Search: 606/108, 606/198, 606/194, 623/1.11, 623/1.12
• US Class Current: 606/108
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped

Abstract

A medical device delivery system is disclosed which has a distal inner sheath and a distal outer sheath covering a medical device mounting region and any medical device mounted thereon. The outer sheath is designed to retain the medical device for lengthy periods of time while the inner sheath is designed to retain the sheath for shorter periods of time.

Claims

1. A medical device delivery system having a proximal end and a distal end comprising:

an inner tube having a distal region and a proximal region and a medical device region at the distal region for disposing a medical device thereabout;

a distal inner sheath disposed about at least a portion of the medical device region,

an inner sheath retraction device extending from the distal inner sheath to the proximal end of the medical device delivery system;

a distal outer sheath disposed about at least a portion of the medical device region; and

an outer sheath retraction device extending from the distal outer sheath to the proximal end of the medical device delivery system wherein the distal inner sheath is constructed to be less creep resistant than the distal outer sheath.

2. The medical device delivery system of claim 1 wherein the retraction device comprises a pull-collar with a pull wire attached thereto.

3. The medical device delivery system of claim 1 wherein at least one of the inner sheath and the outer sheath is made of a porous material.

4. The medical device delivery system of claim 1 further comprising a medical device selected from the group consisting of stents, grafts and vena cava filters, the medical device disposed about the medical device region.

5. The medical device delivery system of claim 4 wherein the medical device is a stent.

6. The medical device delivery system of claim 5 wherein the stent is self-expandable.

16. The stent delivery system of claim 5 wherein the stent is balloon expandable.

7. A medical device delivery system having a proximal end and a distal end comprising:

an inner tube having a distal region and a proximal region and a medical device region at the distal region for disposing a medical device thereabout;

a distal inner sheath disposed about at least a portion of the medical device region,

an inner sheath retraction device extending from the distal inner sheath to the proximal end of the medical device delivery system;

a distal outer sheath disposed about at least a portion of the medical device region; and

an outer sheath retraction device extending from the distal outer sheath to the proximal end of the medical device delivery system wherein the distal outer sheath is made of a thicker material than the distal inner sheath.

8. A medical device delivery system having a proximal end and a distal end comprising:

an inner tube having a distal region and a proximal region and a medical device region at the distal region for disposing a medical device thereabout;

a distal inner sheath disposed about at least a portion of the medical device region,

an inner sheath retraction device extending from the distal inner sheath to the proximal end of the medical device delivery system;

a distal outer sheath disposed about at least a portion of the medical device region; and

an outer sheath retraction device extending from the distal outer sheath to the proximal end of the medical device delivery system wherein the distal inner sheath is a perforated tear away sheath.

9. A medical device delivery system having a proximal end and a distal end comprising:

an inner tube having a distal region and a proximal region and a medical device region at the distal region for disposing a medical device thereabout;

a distal inner sheath disposed about at least a portion of the medical device region,

an inner sheath retraction device extending from the distal inner sheath to the proximal end of the medical device delivery system;

a distal outer sheath disposed about at least a portion of the medical device region; and

an outer sheath retraction device extending from the distal outer sheath to the proximal end of the medical device delivery system wherein the outer sheath retraction device comprises;

a proximal outer tube having a distal end;

a collapsible sheath having a proximal end and a distal end, the proximal end of the collapsible sheath extending from the distal end of proximal outer tube;

a distal outer tube having a proximal end and a distal end, the proximal end of the distal outer tube extending from the distal end of the collapsible sheath; and

a slidable pull wire extending proximally from the distal outer sheath,

whereby the distal end of the retraction device moves in a proximal direction on sliding the pull wire proximally.

10. A medical device delivery system having a proximal end and a distal end comprising:

an inner tube having a distal region and a proximal region and a medical device region at the distal region for disposing a medical device thereabout;

a distal inner sheath disposed about at least a portion of the medical device region,

an inner sheath retraction device extending from the distal inner sheath to the proximal end of the medical device delivery system;

a distal outer sheath disposed about at least a portion of the medical device region; and

an outer sheath retraction device extending from the distal outer sheath to the proximal end of the medical device delivery system wherein the distal inner sheath has an inner surface facing the inner tube and an outer surface facing the distal outer sheath and the distal outer sheath has an inner surface facing the distal inner sheath and an outer surface facing outward and a lubricant is applied to at least a portion of at least one of the outer surface of the distal inner sheath or the inner surface of the distal outer sheath so as to reduce frictional forces between the distal inner sheath and the distal outer sheath.

11. A stent delivery system having a proximal end and a distal end comprising:

an inner tube with a distal region and a proximal region and a stent disposal region at the distal region for disposing a stent thereabout;

a distal inner sheath disposed about the inner tube and covering the stent disposal region;

an inner sheath retraction device having a distal end and a proximal end, the inner sheath retraction device extending proximally from the distal inner sheath;

a distal outer sheath at least a portion of the outer sheath disposed about the stent disposal region; and

an outer sheath retraction device having a distal end and a proximal end, the outer sheath retraction device extending proximally from the distal outer sheath wherein the distal inner sheath is constructed to be less creep resistant than the distal outer sheath.

12. A stent delivery system having a proximal end and a distal end comprising:

an inner tube with a distal region and a proximal region and a stent disposal region at the distal region for disposing a stent thereabout;

a distal inner sheath disposed about the inner tube and covering the stent disposal region;

an inner sheath retraction device having a distal end and a proximal end, the inner sheath retraction device extending proximally from the distal inner sheath;

a distal outer sheath at least a portion of the outer sheath disposed about the stent disposal region; and

an outer sheath retraction device having a distal end and a proximal end, the outer sheath retraction device extending proximally from the distal outer sheath wherein the distal outer sheath is made of a thicker material than the distal inner sheath.

13. The stent delivery system of claim 12 wherein the inner sheath retraction device comprises a pull-collar with a pull wire attached thereto.

14. The stent delivery system of claim 12 wherein at least one of the inner sheath and the outer sheath is made of a porous material.

15. The stent delivery system of claim 12 further comprising a stent disposed about the medical device region.

17. The stent delivery system of claimed wherein the stent is self-expandable.

18. A stent delivery system having a proximal end and a distal end comprising:

an inner tube with a distal region and a proximal region and a stent disposal region at the distal region for disposing a stent thereabout;

a distal inner sheath disposed about the inner tube and covering the stent disposal region;

an inner sheath retraction device having a distal end and a proximal end, the inner sheath retraction device extending proximally from the distal inner sheath;

a distal outer sheath at least a portion of the outer sheath disposed about the stent disposal region; and

an outer sheath retraction device having a distal end and a proximal end, the outer sheath retraction device extending proximally from the distal outer sheath wherein the outer sheath retraction device comprises;

a proximal outer tube having a distal end;

a collapsible sheath having a proximal and a distal end, the proximal end of the collapsible sheath extending from the distal end of proximal outer tube;

a distal outer tube having proximal and distal ends, the proximal end of the distal outer tube extending from the distal end of the collapsible sheath; and

a slidable pull wire extending proximally from the distal outer sheath,

whereby the distal end of the retraction device moves in a proximal direction on sliding the pull wire proximally.

19. A stent delivery system having a proximal end and a distal end comprising:

an inner tube with a distal region and a proximal region and a stent disposal region at the distal region for disposing a stent thereabout;

a distal inner sheath disposed about the inner tube and covering the stent disposal region;

an inner sheath retraction device having a distal end and a proximal end, the inner sheath retraction device extending proximally from the distal inner sheath;

a distal outer sheath at least a portion of the outer sheath disposed about the stent disposal region; and

an outer sheath retraction device having a distal end and a proximal end, the outer sheath retraction device extending proximally from the distal outer sheath wherein the inner sheath has an inner surface facing the inner tube and an outer surface facing the distal outer sheath and the distal outer sheath has an inner surface facing the distal inner sheath and an outer surface facing outward and a lubricant is applied to at least a portion of at least one of the outer surface of the distal inner sheath or the inner surface of the distal outer sheath so as to reduce frictional forces between the distal inner sheath and the distal outer sheath.

20. A medical device delivery system having a proximal and a distal end comprising:

an inner tube with a distal region and a proximal region, the inner tube having a medical device region at the distal region for disposing a medical device thereabout;

a distal inner scored tear away sheath disposed about the inner tube and covering at least a portion of the medical device region; and

a distal outer sheath, disposed about the distal inner scored tear away sheath and

an outer sheath retraction device having a distal end and a proximal end, the outer sheath retraction device extending proximally from the distal outer sheath wherein the distal inner scored tear away sheath is constructed to be less creep resistant than the distal outer sheath.

21. The medical device delivery system of claim 20 wherein the distal outer sheath is constructed to be creep resistant.

22. The medical device delivery system of claim 20 wherein the retraction device comprises a pull-collar with a pull wire attached thereto.

23. The medical device delivery system of claim 20 wherein at least one of the distal inner scored tear away sheath and the distal outer sheath is made of porous material.

24. The medical device delivery system of claim 20 further comprising a medical device selected from the group consisting of stents, grafts and vena cava filters, the medical device disposed about the medical device region.

25. The medical device delivery system of claim 24 wherein the medical device is a stent.

26. The medical device delivery system of claim 25 wherein the stent is self-expandable.

27. A medical device delivery system having a proximal and a distal end comprising:

an inner tube with a distal region and a proximal region, the inner tube having a medical device region at the distal region for disposing a medical device thereabout;

a distal inner scored tear away sheath disposed about the inner tube and covering at least a portion of the medical device region; and

a distal outer sheath, disposed about the distal inner scored tear away sheath and

an outer sheath retraction device having a distal end and a proximal end, the outer sheath retraction device extending proximally from the distal outer sheath wherein the distal outer sheath is made of a thicker material than the distal inner scored tear away sheath.

28. A medical device delivery system having a proximal and a distal end comprising:

an inner tube with a distal region and a proximal region, the inner tube having a medical device region at the distal region for disposing a medical device thereabout;

a distal inner scored tear away sheath disposed about the inner tube and covering at least a portion of the medical device region; and

a distal outer sheath, disposed about the distal inner scored tear away sheath and

an outer sheath retraction device having a distal end and a proximal end, the outer sheath retraction device extending proximally from the distal outer sheath wherein the distal inner scored tear away sheath has an inner surface facing the inner tube and an outer surface facing the distal outer sheath and the distal outer sheath has an inner surface facing the distal inner scored tear away sheath and an outer surface facing outward and a lubricant is applied to at least a portion of at least one of the outer surface of the distal inner scored tear away sheath or the inner surface of the distal outer sheath so as to reduce frictional forces between the distal outer sheath and the distal inner scored tear away sheath.

29. In a stent delivery system comprising a first retractable sheath carried over a stent, the first retractable sheath having an associated retraction device, the improvement being a second retractable sheath carried over the first retractable sheath, the second retractable sheath having an associated retraction device, the first retractable sheath constructed to be less creep resistant than the second retractable sheath.