Single layer hydraulic sheath stent delivery apparatus and method

• US 5,445,646 A
• Filed: 05/19/1994
• Issued: 08/29/1995
• Est. Priority Date: 10/22/1993
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Euteneuer, Charles L., Burmeister, Paul H., Peterson, Dean A., Fraser, Phlayne M.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US08/245,919
• Time in Patent Office: 467 Days
• Field of Search: 606/191, 606/194, 606/108, 606/192, 606/194, 606/195, 606/198, 606/200, 604/96, 604/104, 623/1, 623/12
• US Class Current: 606/198
• 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 2002/9583 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 delivery system for implantation of a stent in a vessel, comprising:

elongate flexible catheter means having proximal and distal ends for delivering a self-expanding stent to a predetermined location in a vessel;

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

stent retaining and release means for retaining the stent in the delivery configuration and for deploying the stent, the stent retaining and release means comprising single layer sheath retaining means surrounding the stent for retaining the stent in its delivery configuration, and slipping sleeve means for releasing the stent to self-expand, the slipping sleeve means attached to the single layer sheath retaining means, the slipping sleeve means being formed of a double walled section of material folded over onto itself, and further including inflation means for inflating the slipping sleeve means with fluid, wherein increased fluid pressure in the slipping sleeve means causes the slipping sleeve means to move axially away from the stent, retracting the single layer sheath retaining means, thereby releasing the stent to self-expand.

2. The delivery system of claim 1 wherein one end of the slipping sleeve means is fixedly connected to the catheter means and the other end of the slipping sleeve means is connected to the catheter means with slip seal means and wherein the single layer sheath retaining means is a single elongate section of sheath material retaining the stent in its delivery configuration, and where the stent is released from an end as the single layer sheath retaining is retracted.

3. The delivery system of claim 1 wherein the single layer sheath retaining means is comprised of proximal and distal sections of sheath material, each respectively retaining the proximal and distal portions of the stent in the delivery configuration, and wherein the slipping sleeve means is comprised of proximal and distal slipping sleeves, each being formed of a doubled over section of material folded over onto itself, and where the end of each slipping sleeve closest to the stent is fixedly attached to the catheter means and the other end of each slipping sleeve is connected to the catheter means with slip seal means, each slipping sleeve being attached to its respective section of single layer sheath retaining material, whereby the fluid pressure in each slipping sleeve causes the slip seals to slid axially away from the stent, retracting the sections of single layer sheath retaining material, providing medial release and self-expansion of the stent.

4. The delivery system of claim 3 further including means for individually controlling the movement of each sleeve, wherein the means for individually controlling the movement of each sleeve is comprised of a separate fluid lumen for controlling the inflation of each sleeve whereby the user may selectively release the distal end of the stent first, release the proximal end of the stent first or release both ends simultaneously.

5. The delivery system of claim 1 further including dissolving band means comprised of at least one water soluble band surrounding the stent and retaining the stent in the delivery configuration and wherein fluid is allowed access to the dissolving band means by retracting the single layer sheath retaining means, whereby the dissolving band means is dissolved, thereby releasing the stent to self-expand.

6. The delivery system of claim 1 further including swelling band means comprised of at least one band attached to and surrounding the catheter means, which is made of water swelling material and to which the stent is pressed into and held in its delivery configuration, and wherein fluid is allowed access to the swelling band means by retracting the single layer sheath retaining means, whereby the swelling band means swells, thereby releasing the stent to self-expand.

7. A method of deploying a stent utilizing the delivery system of claim 1, comprising the steps of:

securing the stent in the delivery configuration using the stent retaining and release means;

moving the distal end of the catheter means to a predetermined deployment site;

releasing the stent using the stent retaining and release means.

8. The method of claim 7 including the further step of controlling the release of the stent such that the stent self-expands in a predetermined manner.

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

elongate flexible catheter means having proximal and distal ends for delivering a stent to a predetermined location in a vessel;

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

stent retaining and release means for retaining the stent in the delivery configuration and for deploying the stent, the stent retaining and release means comprising single layer sheath retaining means surrounding the stent for retaining the stent in its delivery configuration, and slipping sleeve means for releasing the stent for expansion, the slipping sleeve means attached to the single layer sheath retaining means, the slipping sleeve means being formed of a double walled section of material folded over onto itself, and including inflation means for inflating the slipping sleeve means with fluid, wherein increased fluid pressure in the slipping sleeve means causes the slipping sleeve means to move axially away from the stent, retracting the single layer sheath retaining means, and

balloon expansion means arranged inside the stent to expand the stent.

10. A method of deploying a stent utilizing the delivery system of claim 9, comprising the steps of:

enclosing the stent in the delivery configuration using the stent retaining and release means;

moving the distal end of the catheter means to a predetermined deployment site;

releasing the stent using the stent retaining and release means, and

expanding the stent with the balloon expansion means.