Self-expanding stent delivery catheter

• US 6,120,522 A
• Filed: 08/27/1998
• Issued: 09/19/2000
• Est. Priority Date: 08/27/1998
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Munsinger, Joel R., Germain, Jon St., Vrba, Anthony C.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US09/141,209
• Time in Patent Office: 754 Days
• Field of Search: 606/1, 606/108, 606/192, 606/194, 606/198, 606/200, 623/1, 623/12, 623/1.11
• US Class Current: 606/190
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30448 using adhesives
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

The present invention provides a self-expanding stent delivery system comprising a catheter, a self-expanding stent having a plurality of interconnected expansion cells therein and concentrically arranged around the catheter near the distal end of the catheter, a retractable sheath for covering the stent constructed and arranged for retraction to release the stent to self-expand, and a stent holder abutting the stent for holding the stent in place until the retractable sheath is fully retracted. During retraction of the retractable cover, the stent holder prevents the stent from substantially moving longitudinally until the retractable sheath has been completely removed from the stent.

Claims

1. A self-expanding stent delivery system comprising:

a catheter having proximal and distal ends;

a self-expanding stent concentrically arranged around the catheter near the distal end, the stent having proximal and distal ends, the stent having an unexpanded state and an expanded state following self expansion, the stent having an inner surface which faces the catheter and an outer surface which faces away from the catheter;

a retractable sheath for covering the stent constructed and arranged for retraction to release the stent to self-expand, the retractable sheath located at the distal end of the catheter and disposed coaxially about the catheter;

a stent holder adjacent to at least a portion of the stent for holding the stent in place until the retractable sheath is retracted, the stent holder formed of a profiled extrusion around a portion of the catheter, the stent holder frictionally engaging only the inner surface of the proximal end of the stent in the unexpanded state, the stent holder during retraction of the retractable sheath preventing the stent from substantially moving longitudinally until the retractable sheath has been removed from the stent.

2. The stent delivery system of claim 1 further comprising a pull back means for retracting the retractable cover, the pull back means operatively connected to the retractable cover.

3. The stent delivery system of claim 2 wherein the pull back means comprises a pull collar assembly having a pull wire attached thereto, the pull wire extending to the proximal end of the catheter.

4. The stent delivery system of claim 1 further comprising a bumper carried by the catheter and affixed to the catheter at a position adjacent the proximal end of the stent.

5. The stent delivery system of claim 1 further comprising a tip at the distal end of the catheter, the distal end of the sheath abutting the tip to form a stent chamber.

6. The stent delivery system of claim 1 further comprising one or more marker bands carried by the catheter and positioned underneath the stent.

7. The stent delivery system of claim 1 comprising a first marker band underneath the proximal end of the stent and a second marker band underneath the distal end of the stent.

8. The stent delivery system of claim 1 wherein the stent is a nitinol self expanding stent.

9. The stent delivery system of claim 1 further comprising one or more marker bands.

10. The stent delivery system of claim 9 having a first marker band and a second marker band, the first marker band situated at the proximal end of the stent between the stent holder and the catheter.

15. A method of controllably delivering a self expanding stent having distal and proximal ends, the stent having an unexpanded state and an expanded state, comprising the steps of:

providing a stent delivery system as in claim 1 and a stent;

mounting the stent in the unexpanded state on the catheter;

surrounding at least a portion of the stent with a retractable sheath for preventing the stent from self expanding;

engaging the stent with the stent holder;

inserting at least a portion of the stent delivery system into a bodily vessel;

delivering the stent to a desired location in the body;

fully retracting the retractable sheath thereby allowing the stent to self expand;

deploying the stent; and

withdrawing the stent delivery system.

16. The method of claim 15 the retractable sheath having a proximal end and a distal end, the stent holder comprising an elastic membrane situated at the distal end of the sheath and arranged so as to frictionally engage at least a portion of the stent during retraction of the retractable sheath and prevent the stent from self deploying.

11. A self-expanding stent delivery system comprising:

a catheter having proximal and distal ends;

a self-expanding stent having an unexpanded state and an expanded state, the stent concentrically arranged around the catheter near the distal end, the stent having proximal and distal ends, the stent having an inner surface facing the catheter, the inner surface of the stent in the unexpanded state at a first radial distance from the catheter and an outer surface facing outward, the outer surface of the stent in the unexpanded state at a second radial distance from the catheter, the stent having at least one retention opening therein;

a retractable sheath for covering the stent constructed and arranged for retraction to release the stent to self-expand, the retractable sheath located at the distal end of the catheter, the retractable sheath having a proximal end and a distal end,

a stent holder comprising an elastic membrane situated at the distal end of the sheath and arranged so as to frictionally engage at least a portion of the stent during retraction of the retractable sheath and prevent the stent from self deploying.

12. A medical device delivery system comprising:

a catheter having proximal and distal ends;

a medical device disposed about the catheter near the distal end, the medical device having an inner surface facing the catheter and an outer surface facing away from the catheter;

a retractable sheath for covering the medical device, the retractable sheath constructed and arranged for retraction to release the medical device, the retractable sheath located at the distal end of the catheter and disposed coaxially about the catheter, the retractable sheath having a proximal end and a distal end;

a medical device holder adjacent to at least a portion of the medical device for holding the medical device in place until the retractable sheath is retracted, the medical device holder consisting of a profiled extrusion around a portion of the catheter, the medical device holder frictionally engaging only the proximal end of the inner surface of the medical device

whereby during retraction of the retractable sheath the medical device holder prevents medical device from substantially moving longitudinally until the retractable sheath has been removed from the medical device.

13. A medical device delivery system comprising:

a catheter having proximal and distal ends;

a medical device concentrically arranged around the catheter near the distal end, the medical device having proximal and distal ends;

a retractable sheath for covering the medical device, the retractable sheath constructed and arranged for retraction to release the medical device, the retractable sheath located at the distal end of the catheter, the retractable sheath having a proximal end and a distal end,

a medical device holder located at the distal end of the retractable sheath and comprising a portion of the retractable sheath tapered inward toward the catheter so as to frictionally engage at least a portion of the medical device during retraction of the retractable sheath and prevent the medical device from moving substantially longitudinally

whereby during retraction of the retractable sheath the stent holder prevents the stent from substantially moving longitudinally until the retractable sheath has been removed from the stent.

14. A medical device delivery system comprising:

a catheter having proximal and distal ends;

a medical device disposed around the catheter near the distal end, the medical device having proximal and distal ends;

a retractable sheath for covering the medical device constructed and arranged for retraction to release the medical device, the retractable sheath located at the distal end of the catheter, the retractable sheath having a proximal end and a distal end,

a medical device holder located at the distal end of the retractable sheath and comprising an elastic membrane situated at the distal end of the sheath and arranged so as to frictionally engage at least a portion of the medical device during retraction of the retractable sheath and prevent the medical device from deploying before the sheath is completely retracted.

17. A method of controllably delivering a self expanding stent having distal and proximal ends, the stent having an unexpanded state and an expanded state, comprising the steps of:

a) providing a self-expanding stent delivery system comprising

1) a catheter having proximal and distal ends;

2) a self-expanding stent concentrically arranged around the catheter near the distal end, the stent having proximal and distal ends, the stent having an unexpanded state and an expanded state following self expansion;

3) a retractable sheath for covering the stent constructed and arranged for retraction to release the stent to self-expand, the retractable sheath located at the distal end of the catheter and disposed coaxially about the catheter;

4) a stent holder adjacent to at least a portion of the stent for holding the stent in place until the retractable sheath is retracted;

whereby during retraction of the retractable sheath the stent holder prevents the stent from substantially moving longitudinally until the retractable sheath has been removed from the stent

b) providing a stent;

c) mounting the stent in the unexpanded state on the catheter;

d) surrounding at least a portion of the stent with a retractable sheath for preventing the stent from self expanding;

e) engaging the stent with the stent holder;

f) purging the stent delivery system of air and subsequently inserting at least a portion of the stent delivery system into a bodily vessel;

g) delivering the stent to a desired location in the body;

h) fully retracting the retractable sheath thereby allowing the stent to self expand;

deploying the stent; and

i) withdrawing the stent delivery system from the body.

18. A stent delivery system comprising:

a catheter having proximal and distal ends, the catheter having a stent mounting region on the distal end;

a retractable sheath for covering the stent mounting region, the retractable sheath having a proximal end and a distal end, the retractable sheath constructed and arranged for retraction from over the stent mounting region, the retractable sheath located at the distal end of the catheter and disposed coaxially about the catheter;

a stent holder for holding a stent in place until the retractable sheath is retracted, the stent holder located at the distal end of the retractable sheath and comprising a portion of the retractable sheath tapered inward toward the catheter so as to frictionally engage at least a portion of the stent during retraction of the retractable sheath and prevent the stent from moving substantially longitudinally until the retractable sheath has been removed from over a said stent.

19. A method of securing a stent to a stent delivery system comprising the steps of:

providing a stent delivery system comprising a catheter with a stent mounting region thereon, the stent mounting region exposed and a retractable sheath having a stent holder extending from the distal end thereof, the retractable sheath retractable between a closed position in which the sheath overlies the stent mounting region of the catheter and an open position in which the sheath does not overly the mounting region;

mounting a stent on the stent mounting region of the catheter; and

moving the retractable sheath so that it is in its closed position overlying the stent and stent mounting region of the catheter, the stent holder engaging the stent.