Apparatus for deploying body implantable stents

• US 6,380,457 B1
• Filed: 10/27/1997
• Issued: 04/30/2002
• Est. Priority Date: 12/30/1992
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Healy, Steven J., Yurek, Matthew T.
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US08/958,066
• Time in Patent Office: 1,646 Days
• Field of Search: 606/108, 606/157, 606/191-200, 623/1, 623/11, 623/12, 623/1.11, 623/1.2, 623/1.23
• US Class Current: 623/1.11
• 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 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• 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

Abstract

A stent deployment device includes a flexible, elongate interior catheter and a retaining structure cooperating with the catheter to support a stent along a distal end support region of the catheter. The stent is supported in a reduced radius delivery state to facilitate delivery to a treatment site in a body lumen, by advancing the device over a previously positioned guidewire. An opening at the distal end of the device receives the guidewire into a guidewire lumen of the interior catheter. A second opening through the catheter wall just proximally of the support region allows passage of the guidewire to the exterior of the catheter, whereby the guidewire is contained within the device only along the distal end region. The retaining structure can include an exterior catheter surrounding the interior catheter and stent, and moveable axially relative to the interior catheter. A portion of the guidewire proximally of the second opening is contained between the catheters, and can be removed from the exterior catheter through a slit running axially along the exterior catheter.

Claims

1. In combination, a self-expanding stent and a device for deploying the stent in a body vessel, the combination comprising:

(a) an inner member having a side wall and a distal-most portion, and a first opening through the side wall along the distal-most portion;

(b) a self-expanding stent disposed in a radially contracted state about at least part of the inner member distal-most portion, distally of the first opening;

(c) an outer tubular member adapted to be disposed at a selected location about the inner member distal-most portion and the stent and longitudinally movable relative to the inner member distal-most portion and the stent, toward and away from the selected location, said outer tubular member incorporating a slit to allow passage of a guidewire through the outer tubular member, said slit being disposed near the first opening and spaced proximally of the stent when the outer tubular member is at the selected location; and

(d) a guidewire lumen disposed between the first opening through said side wall and a second opening in the inner member distal of the first opening, the guidewire lumen thereby accommodating a guidewire within at least part of the inner member distal-most portion.

2. The combination of claim 1, wherein:

the side wall, distally of the first opening, forms a continuous enclosure around the guidewire lumen.

3. The combination of claim 2, wherein:

said outer tubular member includes a distal end region and an outer-member lumen extending therethrough, said outer tubular member, when at said selected location, containing the distal-most portion and stent within the outer-member lumen.

4. The combination of claim 2, wherein:

said second opening is disposed at a distal tip of the inner member.

5. The combination of claim 2, wherein:

said outer tubular member when moved longitudinally relative to the inner member in a proximal direction away from the selected location, releases the stent for radial self-expansion.

6. In combination, a stent and a device for deploying the stent in a body vessel, the combination including:

a stent carrier having a side wall, a distal end region, and a first opening through the side wall along the distal end region;

a flexible stent disposed about at least part of the distal end region and located distally of the first opening;

a stent retainer comprising a rolling membrane disposed at least partially about the distal end region of the stent carrier and the stent, and, when so disposed exerting a stent-retaining force upon the flexible stent to maintain the stent in a radially contracted state;

said stent retainer further being movable longitudinally relative to the stent carrier and the stent to release the stent and thereby allow an expansion of the stent to a radially enlarged state; and

a guidewire lumen disposed between the first opening through the side wall and a second opening in the stent carrier distal of the first opening, the guidewire lumen passing within at least part of the distal end region of the stent carrier and adapted to accommodate a guidewire, wherein the first opening at least at a distal end portion thereof is larger in diameter than the guidewire, and the side wall distally of the first opening forms a continuous enclosure around the guidewire lumen.

7. The combination of claim 6, wherein:

said retainer further comprises a tubular catheter supporting the rolling membrane at a catheter distal end region.

8. The combination of claim 7, wherein:

said tubular catheter is movable proximally relative to the stent carrier to move the rolling membrane and thus release the stent for radial self-expansion.

9. The combination of claim 6, wherein:

said stent carrier comprises an inner catheter having a distal tip, and the second opening is disposed at the distal tip.

10. The combination of claim 6, wherein:

the stent retainer comprises a retainer wall, and the retainer wall incorporates a slit disposed proximally of the stent when the stent retainer is so disposed about the distal end region of the stent carrier and the stent, to allow passage of a guidewire through the retainer wall.

11. An assembly including a self-expanding stent and a stent delivery device, including:

a stent carrier having a side wall, a distal end region, and a first opening through the side wall along the distal end region;

a radially self-expanding stent disposed about the stent carrier along the distal end region, distally of the first opening;

a tubular catheter having a catheter lumen adapted to contain the stent carrier for axial movement relative to the catheter, the catheter being selectively positionable axially at a selected location relative to the stent carrier whereby a distal portion of the catheter surrounds the stent when the stent is disposed about the stent carrier along the distal end region, thereby to maintain the stent in a radially contracted state against an internal restoring force, said catheter along said distal portion being continuous in a circumferential direction and surrounding the stent substantially over the entire axial length thereof;

said catheter further being movable longitudinally relative to the stent carrier and the stent, to release the stent from the distal portion of the catheter and thereby allow the stent to self-expand under the internal restoring force to a radially enlarged state; and

a guidewire lumen disposed between the first opening through the side wall and a second opening in the stent carrier disposed distally of the first opening, the guidewire lumen passing within at least part of the distal end region of the stent carrier and adapted to accommodate a guidewire.

12. The assembly of claim 11 wherein:

said first opening is larger in diameter than the guidewire, and the side wall distally of the first opening forms a continuous enclosure around the guidewire lumen.

13. The assembly of claim 11, further including:

a slit running axially along the tubular catheter, beginning proximally of said distal portion and extending proximally toward a proximal end of the catheter.

14. A stent deployment device, including:

an elongate and flexible stent carrier adapted to carry a radially self-expanding stent in a radially contracted state, extended along and surrounding at least part of a distal end region of the stent carrier;

a guidewire lumen formed through the distal end region of the stent carrier to accommodate a guidewire, said guidewire lumen being open to an exterior of the stent carrier at first and second openings along the distal end region, the second opening being spaced apart distally from the first opening; and

a stent confining device comprising a catheter and a rolling membrane attached to a distal end portion of the catheter, said rolling membrane comprising a tubular wall, the stent confining device being selectively axially positionable relative to the stent carrier to locate the tubular wall at a selected location along and in surrounding relation to the distal end region of the stent carrier, said tubular wall being continuous circumferentially and, when a radially self-expanding stent is so carried by the carrier, surrounding the stent along substantially the entire axial length thereof and thereby adapted to maintain the stent in a radially contracted state against an internal restoring force;

wherein the stent confining device is movable relative to the stent carrier, and when a self-expanding stent is so carried by the stent carrier, further is movable relative to the stent away from the selected location to release the stent and thereby allow the stent to self-expand under the internal restoring force to a radially enlarged state; and

a third opening adapted to allow passage of the guidewire through the tubular wall, the third opening being disposed proximate said first opening and disposed proximally of a radially self-expanding stent when the stent is so carried by the stent carrier with the tubular wall at the selected location.

15. The device of claim 14 wherein:

said third opening comprises a slit extending proximally toward a proximal end of the stent confining device.

16. The device of claim 14 wherein:

said stent confining device comprises a tubular catheter, with said tubular wall comprising a distal end portion of the catheter.

17. The device of claim 14 wherein:

the first opening, at least at a distal end thereof, is wider than a diameter of the guidewire.

18. The device of claim 14 wherein:

the carrier has a distal tip, and the second opening is disposed at the distal tip.

19. The device of claim 14 further including:

a radially self-expanding stent carried by the stent carrier, extended along and surrounding at least part of the distal end region, and surrounded by said tubular wall and thereby maintained in the radially contracted state.

20. A stent deployment device, including:

an elongate and flexible stent carrier adapted to carry a radially self-expanding stent in a radially contracted state surrounding at least part of a distal end region of the stent carrier;

a guidewire lumen formed through the distal end region of the stent carrier to accommodate a guidewire, the guidewire lumen being open to an exterior of the stent carrier at first and second axially spaced apart openings along the distal end region; and

a stent confining device having a distal portion comprising a tubular wall, the stent confining device being selectively axially positionable relative to the stent carrier to locate the tubular wall at a selected location along and in surrounding relation to the distal end region of the stent carrier, said tubular wall being continuous circumferentially and, when at the selected location, adapted to closely surround a radially self-expanding stent over substantially the entire axial length of the stent when the stent is so carried by the flexible stent carrier, thereby maintaining the stent in a radially contracted state against an internal restoring force;

wherein the stent confining device is movable axially relative to the stent carrier, and further it is movable relative to a self-expanding stent when so carried by the stent carrier, away from the selected location to release the stent and thereby allow the stent to self-expand under the internal restoring force to a radially enlarged state; and

a third opening in the tubular wall adapted to allow passage of the guidewire through the tubular wall, the third opening being disposed proximate the first opening of the stent carrier and spaced proximally of a radially self-expanding stent when the stent is so carried by the stent carrier and the tubular wall is in the selected position.

21. The device of claim 20 wherein:

said third opening comprises a slit extending proximally toward a proximal end of the stent confining device.

22. The device of claim 20 wherein:

said stent confining device comprises a tubular catheter, with said tubular wall comprising a distal end portion of the catheter.

23. The device of claim 20 wherein:

said stent confining device comprises a catheter and a rolling membrane attached to a distal end portion of the catheter, and wherein the rolling membrane comprises said tubular wall.

24. The device of claim 20 wherein:

the first opening, at least at a distal end thereof, is wider than a diameter of the guidewire.

25. The device of claim 20 wherein:

the carrier has a distal tip, and the second opening is disposed at the distal tip.