Apparatus for deploying body implantable stents

• US 6,755,855 B2
• Filed: 03/19/2002
• Issued: 06/29/2004
• Est. Priority Date: 12/30/1992
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Healy, Steven J., Yurek, Matthew T.
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US10/100,944
• Publication Number:
  US 20020099405A1
• Time in Patent Office: 833 Days
• Field of Search: 604/96-1-1, 604/264, 604/523, 604/528, 606/108, 606/159, 606/191-200, 606/213, 600/201, 600/204, 600/207, 600/585, 623/1.11, 623/1.12
• 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 2/966 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. Alternatively, the retaining means can include a pair of spaced apart sleeves integral with the interior catheter and frictionally retaining opposite ends of the stent, to maintain the stent in the delivery state. In this case the catheter further supports a dilatation balloon surrounded by the stent. The balloon is expanded to free the stent from the sleeves.

Claims

1. 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 adapted to be 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 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;

wherein said stent retainer comprises a tubular catheter having a catheter lumen and, when so disposed, contains the distal end region of the stent carrier, and the flexible stent, within the catheter lumen.

2. The combination of claim 1 wherein:

said tubular catheter is movable proximally relative to the stent carrier and the flexible stent to release the flexible stent for radial self-expansion.

3. The stent of claim 1 wherein:

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

4. The combination of claim 1 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.

5. The combination of claim 1 wherein:

the stent retainer comprises a rolling membrane adapted to be disposed about the distal end region of the stent carrier and the flexible stent to exert said stent-retaining force.

6. 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 adapted to be disposed about the stent carrier along the distal end region, distally of the first opening;

a stent retainer having a distal section selectively positionable axially at a selected location relative to the stent carrier in surrounding relation to 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 along the distal end region against an internal restoring force, said distal section being continuous in a circumferential direction and surrounding the stent substantially over the entire axial length thereof;

said stent retainer further being movable proximally relative to the stent carrier and the stent, to release the stent from the distal section 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.

7. The assembly of claim 6 wherein:

the stent retainer comprises a catheter, said distal section comprises a distal section of the catheter, and the catheter further comprises a proximal section incorporating a longitudinally extended slit to allow passage of a guidewire through the catheter, said slit being disposed near the first opening and spaced proximally of the stent when the distal section is at the selected location.

8. The assembly of claim 7 wherein:

said slit runs substantially the entire length of the proximal section of the catheter.

9. The assembly of claim 6 wherein:

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

10. The assembly of claim 6 wherein:

the side wall, between the first opening and the second opening, is continuous in the circumferential direction.

11. 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;

wherein the first opening is proximally spaced apart from the second opening; and

a stent retaining device having a distal confining section and being selectively axially positionable relative to the stent carrier to locate the distal confining section at a selected location along the distal end region to surround a radially self-expanding stent along substantially the entire axial length thereof when the stent is so carried by the stent carrier, said distal confining section being continuous in a circumferential direction, thereby to maintain the stent in the radially contracted state along the distal end region, against an internal restoring force;

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

12. The device of claim 11 wherein:

the stent retaining device comprises a catheter having a catheter wall and a catheter lumen running substantially the entire length thereof, and the distal confining section comprises a distal section of the catheter.

13. The device of claim 12 further including:

a third opening through the catheter wall adapted to allow passage of the guidewire into and out of the catheter lumen, the third opening being disposed proximate the first opening and proximally of a radially self-expanding stent when the stent is so carried by the stent carrier and the distal section is at the selected location.

14. The device of claim 13 wherein:

said third opening comprises a slit extending proximally toward a proximal end of the catheter.

15. The device of claim 11 wherein:

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

16. The device of claim 11 wherein:

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

17. The device of claim 11 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 distal confining section and thereby maintained in the radially contracted state.

18. The device of claim 11 wherein:

said stent retaining device comprises a catheter and a rolling membrane attached to a distal end portion of the catheter, and the distal confining section comprises the rolling membrane.