Apparatus for deploying body implantable stent

• US 5,690,644 A
• Filed: 02/20/1996
• Issued: 11/25/1997
• Est. Priority Date: 12/30/1992
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Schneider Electric SE
• Inventors: Healy, Steven J., Yurek, Matthew T.
• Primary Examiner(s): DAWSON, GLENN K
• Application Number:
  US08/603,683
• Time in Patent Office: 644 Days
• Field of Search: 606/108, 606/191-198, 604/96-104, 128/657, 128/772, 623/1, 623/11, 623/12
• 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. A retainer for the stent 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 stent retainer 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. An apparatus for deploying a prosthesis at a treatment site within a body lumen, in combination with the prosthesis, including:

an elongate prosthesis carrier having a proximal end region, a distal end region having a distal end region axial length, a carrier wall defining a guidewire lumen running axially of the carrier at least along the distal end region, a first opening disposed at a distal end of the distal end region for admitting a guidewire into the guidewire lumen, a second opening through the carrier wall at a proximal end of the distal end region, for providing egress of the guidewire out of the guidewire lumen, and a means for channeling the guidewire out of the guidewire lumen through the second opening whereby the carrier contains the guidewire within the guidewire lumen only along the distal end region;

a prosthesis disposed along the distal end region;

a prosthesis retaining means for releasably supporting the prosthesis in a delivery state along the distal end region, said prosthesis retaining means including a rolling membrane folded over on itself in a delivery configuration whereby said membrane includes an outer fold and an inner fold attached to the prosthesis carrier and surrounded by the outer fold, wherein the membrane when in the delivery configuration is adapted to surround the prosthesis, and wherein the outer fold is movable proximally relative to the carrier away from the delivery configuration and, when so moved, tends to remove the rolling membrane proximally from its surrounding relation to the prosthesis to release the prosthesis, said prosthesis when so supported in the delivery state having a prosthesis length slightly less than the distal end region axial length whereby the prosthesis is between said first and second openings, said prosthesis further having a reduced radius along its axial length to facilitate delivery of the prosthesis to a treatment site in a body lumen; and

a control means coupled with respect to the retaining means, for releasing the prosthesis when the distal end region is positioned near the treatment site, thus to facilitate deployment of the prosthesis in a radially expanded state at the treatment site.

2. The apparatus of claim 1 wherein:

the retaining means further comprises a flexible, elongate outer catheter having a catheter wall defining a catheter lumen running axially for substantially the entire length of the outer catheter, the outer catheter having a distal end coupled to the outer fold of said membrane.

3. The apparatus of claim 2 wherein:

the carrier is disposed within the catheter lumen and extends substantially the entire length of the outer catheter, and the outer catheter is movable with respect to the carrier to move the outer fold proximally away from said delivery configuration to release the prosthesis.

4. The apparatus of claim 3 further including:

an outer catheter opening through the catheter wall and disposed near the proximal end of the distal end region when the outer catheter and the carrier are in the delivery configuration.

5. The apparatus of claim 4 wherein:

the outer catheter opening comprises an axial slit extended proximally to a proximal region of the outer catheter.

6. The apparatus of claim 4 wherein:

the carrier comprises an inner catheter having a distal tip, and the first opening is formed through the distal tip.

7. The apparatus of claim 6 wherein:

the outer catheter is moved proximally relative to the inner catheter when moving the membrane away from the delivery configuration to release the prosthesis.

8. The apparatus of claim 7 further including:

a groove in the inner catheter, extended axially from the proximal end of the distal end region to the proximal end region.

9. The apparatus of claim 8 wherein:

the outer catheter opening comprises an axial slit extended proximally to a proximal region of the outer catheter.

10. The apparatus of claim 2 wherein:

the control means further comprises first and second handle means fixed respectively to the proximal end region of the prosthesis carrier and to a proximal end region of the outer catheter, for moving the outer catheter proximally relative to the prosthesis carrier.

11. The apparatus of claim 2 further including:

an axial slit through the catheter wall of the outer catheter, extending from a point near the proximal end of the distal end region when the outer catheter and carrier are in the delivery configuration, to a proximal region of the outer catheter.

12. An apparatus for deploying a prosthesis at a treatment site within a body lumen, in combination with the prosthesis, including:

a flexible, elongate inner catheter having a proximal end region and a distal end region, and further having a catheter wall defining a guidewire lumen open to a distal end of the inner catheter and running axially of the inner catheter at least along said distal end region of the inner catheter, said distal end region having a distal end region axial length;

a prosthesis disposed along the distal end region;

a prosthesis retaining means mounted with respect to the inner catheter and cooperating with the inner catheter to support the prosthesis along the distal end region of the inner catheter and in a delivery state in which the prosthesis has a prosthesis length slightly less than the distal end region axial length, said prosthesis further having a reduced radius along its axial length to facilitate delivery of the prosthesis to a treatment site in a body lumen, said retaining means being operable to release the prosthesis from the delivery state to deploy the prosthesis in a radially expanded state at the treatment site; and

a first opening at said distal end of the inner catheter for receiving a flexible guidewire into the guidewire lumen, a second opening through the catheter wall at a proximal end of the distal end region, said second opening allowing passage of the guidewire from within the guidewire lumen to the exterior of the inner catheter, a means for channeling the guidewire out of the guidewire lumen through the second opening whereby the guidewire is contained within the inner catheter substantially only along said distal end region, and a groove in the inner catheter, extending axially from the proximal end of the distal end region to the proximal end region of the inner catheter.

13. The apparatus of claim 12 wherein:

said retaining means comprises first and second sleeves mounted to the inner catheter and adapted for frictionally retaining respective proximal and distal ends of the prosthesis, a dilatation balloon mounted to the inner catheter between the sleeves and surrounded by the prosthesis, and a balloon inflation lumen running substantially the length of the inner catheter for supplying a fluid under pressure to the dilatation balloon.

14. The apparatus of claim 12 wherein:

said retaining means further comprises an outer catheter having an outer catheter lumen running substantially the entire axial length thereof, for containing the inner catheter, the outer catheter being movable relative to the inner catheter toward and away from a delivery configuration in which a distal end region of the outer catheter is adapted to surround the prosthesis and radially compress the prosthesis to maintain the prosthesis in the delivery state.

15. The apparatus of claim 14 further including:

a slit running axially along the outer catheter, from a point near the proximal end of the distal end region when the catheters are in the delivery configuration to a proximal end region of the outer catheter.

16. The apparatus of claim 12 wherein:

the retaining means includes a dilatation balloon at the distal end region and adapted to be surrounded by the prosthesis, and a balloon inflation lumen open to the dilatation balloon and running substantially the length of the inner catheter, for supplying a fluid under pressure to the dilatation balloon to expand the balloon and thereby radially expand the prosthesis when the balloon is so surrounded.

17. The apparatus of claim 12 wherein:

the retaining means includes a flexible and elongate outer catheter having a catheter wall defining a catheter lumen running substantially the length of the outer catheter, wherein the outer catheter, when disposed in a delivery configuration relative to the inner catheter, is adapted to surround the prosthesis.

18. The apparatus of claim 17 wherein:

the inner catheter includes a distal tip, and the outer catheter is adapted to contain the prosthesis within a distal end portion of the catheter lumen and in surrounding relation to the inner catheter adjacent and proximally of the distal tip when the outer catheter and the inner catheter are in the delivery configuration.

19. The apparatus of claim 18 wherein:

the outer catheter surrounds the prosthesis along the entire length of the prosthesis.

20. The apparatus of claim 18 wherein:

the inner catheter further includes a sleeve integral with the distal tip and extending proximally of the distal tip, the sleeve surrounding a distal portion of the prosthesis and the outer catheter surrounding a proximal portion of the prosthesis when the outer catheter and the inner catheter are in the delivery configuration.

21. The apparatus of claim 20 wherein:

the outer catheter abuts the sleeve when the outer catheter and the inner catheter are in the delivery configuration.

22. An apparatus for deploying a prosthesis at a treatment site within a body lumen, in combination with the prosthesis, including:

an elongate prosthesis carrier having a proximal end region, a distal end region having a distal end region axial length, a carrier wall defining a guidewire lumen running axially of the carrier at least along the distal end region, a first opening disposed at a distal end of the distal end region for admitting a guidewire into the guidewire lumen, a second opening through the carrier wall at a proximal end of the distal end region, for providing egress of the guidewire out of the guidewire lumen, and a means for channeling the guidewire out of the guidewire lumen through the second opening whereby the carrier contains the guidewire within the guidewire lumen only along the distal end region;

a prosthesis disposed along the distal end region;

a flexible, elongate outer catheter having a catheter wall defining a catheter lumen running axially for substantially the entire length of the outer catheter, said carrier being disposed within the catheter lumen and extending substantially the entire length of the outer catheter, the carrier and the outer catheter being movable with respect to one another toward and away from a delivery configuration;

a rolling membrane folded over on itself and including an outer fold attached to the outer catheter and an inner fold attached to the carrier, wherein the rolling membrane is adapted to surround the prosthesis when the carrier and the outer catheter are in the delivery configuration, thus to releasably support the prosthesis in a delivery state along the distal end region;

an outer catheter opening through the catheter wall and disposed near the proximal end of the distal end region when the outer catheter and the carrier are in the delivery configuration, to allow passage of the guidewire from within the catheter lumen to the exterior of the outer catheter, said outer catheter opening comprising an axial slit extended proximally to a proximal region of the outer catheter;

said prosthesis when so supported in the delivery state having a reduced radius along its axial length to facilitate delivery of the prosthesis to a treatment site in a body lumen; and

a control means coupled with respect to the outer catheter, for moving the outer catheter proximally relative to the carrier away from the delivery configuration to remove the rolling membrane proximally from its surrounding relation to the prosthesis, thereby releasing the prosthesis when the distal end region is positioned near the treatment site, thus to facilitate deployment of the prosthesis in a radially expanded state at the treatment site.

23. The apparatus of claim 22 wherein:

the carrier comprises an inner catheter having a distal tip, and the first opening is formed through the distal tip.

24. The apparatus of claim 23 further including:

a groove in the inner catheter, extending axially from the proximal end of the distal end region, to the proximal end region.

25. The apparatus of claim 23 wherein:

the outer catheter is moved proximally relative to the inner catheter when moving away from the delivery configuration to release the prosthesis.

26. The apparatus of claim 23 wherein:

the control means comprises a dilatation balloon disposed along the distal end region of the carrier and adapted to be surrounded by the prosthesis, and a means for supplying a fluid under pressure to the balloon to expand the balloon and thereby radially expand the prosthesis when the balloon is so surrounded.

27. The apparatus of claim 22 wherein:

the carrier includes a distal tip, and the outer catheter is adapted to contain the prosthesis within a distal end portion of the catheter lumen and in surrounding relation to the carrier adjacent and proximally of the distal tip when the outer catheter and carrier are in the delivery configuration.

28. The apparatus of claim 27 wherein:

the outer catheter surrounds the prosthesis along the entire length of the prosthesis.

29. An apparatus for deploying a prosthesis at a treatment site within a body lumen, in combination with a prosthesis, including:

an elongate prosthesis carrier having a proximal end region, a distal end region having a distal end region axial length, a carrier wall defining a guidewire lumen running axially of the carrier at least along the distal end region, a first opening disposed at a distal end of the distal end region for admitting a guidewire into the guidewire lumen, a second opening through the carrier wall at a proximal end of the distal end region, for providing egress of the guidewire out of the guidewire lumen, a means for channeling the guidewire out of the guidewire lumen through the second opening whereby the carrier contains the guidewire within the guidewire lumen only along the distal end region, and a groove in the prosthesis carrier extending axially from the proximal end of the distal end region to the proximal end region of the prosthesis carrier, said prosthesis carrier having a total length in the range of from 15.3 to about 20 times said distal end region axial length;

a prosthesis disposed along the distal end region;

a prosthesis retaining means for releasably supporting the prosthesis in a delivery state along the distal end region, said prosthesis when so supported in the delivery state having a reduced radius along its axial length to facilitate delivery of the prosthesis to a treatment site in a body lumen; and

a control means coupled with respect to the retaining means, for releasing the prosthesis when the distal end region is positioned near the treatment site, thus to facilitate deployment of the prosthesis in a radially expanded state at the treatment site.

30. The apparatus of claim 29 wherein:

the retaining means includes first and second sleeves fixed to the carrier respectively at proximal and distal ends of the distal end region, said sleeves adapted for surrounding and frictionally retaining the prosthesis at respective and opposite ends thereof, to frictionally retain the prosthesis in said delivery state.

31. The apparatus of claim 29 wherein:

said control means includes a dilatation balloon supported at the distal end region and adapted to be surrounded by the prosthesis, and a balloon inflation lumen open to the dilation balloon and running substantially the length of the prosthesis carrier, for supplying a fluid under pressure to the dilatation balloon to expand the balloon and thereby radially expand the prosthesis when the balloon is so surrounded.