Stent delivery apparatus and method

• US 5,989,280 A
• Filed: 06/18/1997
• Issued: 11/23/1999
• Est. Priority Date: 10/22/1993
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Fraser, Phlayne M., Shoemaker, Susan M., Euteneuer, Charles L., Burmeister, Paul H., Peterson, Dean A., Buirge, Andrew W.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US08/633,726
• Time in Patent Office: 888 Days
• Field of Search: 606/1, 606/108, 606/192, 606/194, 606/195, 606/198, 606/200, 623/1, 623/23, 604/96
• US Class Current: 623/1.1
• 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 2/9662 the middle portion of the stent or stent-graft is released first
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• 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
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A delivery system for implantation of a self-expanding stent in a vessel is consists of an elongate flexible catheter for delivering a self-expanding stent to a predetermined location in a vessel. The stent surrounds the flexible catheter near its distal end and is held in a delivery configuration where the stent has a reduced radius along its entire axial length by a stent retaining and release means. The stent retaining and release means is a single layer sheath retaining sleeve means for retaining the stent in its delivery configuration attached to a slipping sleeve means for releasing the stent to self-expand. A balloon may optionally be used to seat the stent in the vessel after self-expansion. The stent may also optionally be retained by water soluble or swelling bands.

Claims

1. A stent delivery system for implantation of a stent in a vessel comprising:

an elongate flexible catheter having proximal and distal ends;

a stent having proximal and distal ends, the stent surrounding the flexible catheter near its distal end, the stent being in a delivery configuration where the stent has a reduced radius along its entire axial length;

a retractable sheath for retaining the stent in the delivery configuration and for deploying the stent, the sheath holding the self-expanding stent in its delivery configuration against the outwardly urging force of the self-expanding stent;

a retraction device for retracting the retractable sheath, the retraction device comprising a piston housing and a piston contained therein, the piston actatable by pressurized fluid supplied to at least a portion of the piston housing by an inflation lumen, the retraction device further comprising a connecting member, one end of which connects to the retractable sheath, the other end of the connecting member connecting to the piston,

whereby the retractable sheath may be retracted by supplying a fluid under pressure to the inflation lumen so as to displace the piston, the piston in turn displacing the retractable sheath so as to expose at least a portion of the stent.

2. The stent delivery system of claim 1 wherein the connecting member comprises a wire.

3. The stent delivery system of claim 1 wherein the piston housing is sealed at one end.

4. The stent delivery system of claim 1 wherein the piston housing is coaxial with the catheter.

5. The stent delivery system of claim 1 wherein the stent is self-expandable.

6. The stent delivery system of claim 1 having only one piston actuatable by pressurized fluid.

7. The stent delivery system of claim 1 further comprising a second retractable sheath for retaining the stent in the delivery configuration and for deploying the stent, the second sheath holding the self-expanding stent in its delivery configuration against the outwardly urging force of the self-expanding stent;

a second retraction device for retracting the second retractable sheath, the second retraction device comprising a second piston housing and a second piston contained therein, the second piston actuatable by a pressurized fluid supplied to at least a portion of the second piston housing from the first piston housing, the second retraction device further comprising a second connecting member, one end of which connects to the second retractable sheath, the other end of the second connecting member connecting to the second piston.

8. The stent delivery system of claim 7 wherein the second connecting member comprises a wire.

9. The stent delivery system of claim 7 wherein the first and second pistons move in opposing directions on retraction of the first and second retractable sheaths.

10. The stent delivery system of claim 7 wherein the stent is self-expandable.

11. A method for delivering a stent to a desired location in a bodily lumen using the stent delivery system of claim 1 comprising the steps of:

providing a stent delivery system as in claim 1;

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

advancing the stent to a desired bodily location;

providing a source of fluid;

supplying the fluid under pressure to the housing so as to actuate the piston and retract the sheath;

deploying the stent;

withdrawing the stent delivery system from the bodily vessel.

12. A medical device delivery system for delivering a medical device to a desired location in a bodily lumen comprising

an elongate flexible catheter having proximal and distal ends, the catheter having a medical device mounting region near its distal end for mounting thereon a medical device;

a retractable sheath covering the medical device mounting region;

a retraction device for retracting the retractable sheath, the retraction device comprising a piston housing and a piston contained therein, the piston in fluid communication with an inflation lumen, a connecting member, one end of which connects to the retractable sheath, the other end of the connecting member connecting to the piston,

whereby the retractable sheath may be retracted by supplying a fluid under pressure to the inflation lumen so as to displace the piston, the piston in turn displacing the retractable sheath from its position over the medical device mounting region.

13. The medical device delivery system of claim 12 wherein the medical device is a stent and the stent is mounted on the medical device mounting region of the catheter.

14. The medical device delivery system of claim 13 wherein the stent is self-expandable.

15. A method for delivering a medical device to a desired location in a bodily lumen using the apparatus of claim 12 comprising the steps of:

providing a medical device delivery system as in claim 12;

providing a medical device for placement about the medical device mounting region;

placing the medical device about the medical device mounting region of the medical device delivery system and covering the medical device with the retractable sheath;

inserting at least a portion of the medical device delivery apparatus in a bodily vessel;

advancing the medical device to a desired bodily location;

providing a source of fluid;

supplying the fluid under pressure to the first housing so as to actuate the piston and retract the sheath;

deploying the medical device;

withdrawing the medical device delivery apparatus from the bodily vessel.

16. The method of claim 15 wherein the medical device is a stent.