Custom-length self-expanding stent delivery systems with stent bumpers

• US 7,300,456 B2
• Filed: 09/17/2004
• Issued: 11/27/2007
• Est. Priority Date: 06/28/2004
• Status: Active Grant

• Current Assignee: JW Medical Systems Ltd
• Original Assignee: XTENT, Inc.
• Inventors: Andreas, Bernard, Grainger, Jeffry J.
• Primary Examiner(s): Dawson; Glenn K.
• Assistant Examiner(s): SONNETT, KATHLEEN C
• Application Number:
  US10/944,282
• Publication Number:
  US 20050288763A1
• Time in Patent Office: 1,166 Days
• Field of Search: 623/1.11, 623/1, 623/1.12, 623/1.2, 623/1.21, 623/1.23, 623/1.16, 623/1.13, 623/1.15, 606/108, 606/191, 606/192, 606/134, 606/195, 606/198, 604/93.01, 604/96.01, 604/101.01, 604/101.05
• 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 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• 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

Custom-length self-expanding stent delivery systems and methods enable precise control of prosthesis position during deployment. The stent delivery systems carry multiple stent segments and include a stent bumper for helping control the axial position of the stent segments during deployment. This enables the deployment of multiple prostheses at a target site with precision and predictability, preventing stent segment recoil and ejection from the delivery device and thus eliminating excessive spacing or overlap between prostheses. In particular embodiments, the prostheses of the invention are deployed in stenotic lesions in coronary or peripheral arteries or in other vascular locations.

Claims

1. A catheter system for delivery of a stent to a body lumen comprising:

a stent delivery catheter comprising;

a sheath having a first lumen;

a shaft extending through the first lumen and slidable relative to the sheath;

a stent bumper mounted to the shaft distally of the sheath and movable from a contracted shape to an expanded shape,

wherein the stent comprises an inflatable balloon, and

wherein the balloon comprises an elongate balloon having an axial length at least as long as two stent segments;

a plurality of self-expanding stent segments carried within the first lumen in a collapsed configuration, the stent segments being adapted to resiliently expand from the collapsed configuration to an expanded configuration,

wherein the stent segments are deployable from the first lumen so as to resiliently expand into the expanded, configuration, the stent bumper being expandable independently of the stent segments and configured in the expanded shape to engage a first stent segment during deployment thereof to maintain its position relative to an adjacent stent segment disposed proximal to the first stent segment; and

an inner sheath disposed over the balloon, wherein the inner sheath is retractable to expose a portion of the balloon to allow it to be inflated from the contracted shape to the expanded shape.

2. A system as in claim 1, wherein the balloon is adapted to be expanded within one or more deployed stent segments to further expand the segments.

3. A method of delivering a stent to a body lumen comprising:

positioning a stent delivery catheter in the body lumen, the delivery catheter carrying at least first and second stent segments;

expanding a stent bumper on the deliver catheter,

wherein expanding the stent bumper comprises inflating a balloon;

releasing the first stent segment from the delivery catheter into the body lumen after the stent bumper has been fully expanded, the first stent segment resiliently self-expanding into an expanded configuration in the body lumen, wherein the stent bumper expands independently of the first stent segment and engages the first stent segment during expansion thereof to maintain its position relative to the delivery catheter;

before releasing the second stent segment,

deflating the balloon;

positioning the deflated balloon within the expanded first stent segment;

inflating the balloon, wherein the balloon engages the second stent segment during expansion thereof to maintain its position relative to the delivery catheter and the first segment; and

releasing the second stent segment from the delivery catheter into the body lumen adjacent to the first stent segment.

4. A method as in claim 3, wherein inflating the balloon within the first segment further expands the first segment.

5. A method as in claim 3, further comprising:

deflating the balloon;

positioning the deflated balloon within the expanded second stent segment; and

inflating the balloon, wherein the balloon engages a third stent segment during expansion thereof to maintain its position relative to the delivery catheter and the first and second segments.

6. A method of delivering a stent to a body lumen comprising:

positioning a stent delivery catheter in the body lumen, the delivery catheter carrying at least first and second stent segments;

expanding a stent bumper on the delivery catheter;

wherein expanding the stent bumper comprises inflating a balloon;

releasing the first stent segment from the delivery catheter into the body lumen after the stent bumper has been fully expanded, the first stent segment resiliently self-expanding into an expanded configuration in the body lumen, wherein the stent bumper expands independently of the first stent segment and engages the first stent segment during expansion thereof to maintain its position relative to the delivery catheter;

before releasing a second stent segment,

exposing an additional portion of the balloon from the distal end of an inner sheath, the additional portion disposed within the expanded first stent segment;

inflating the balloon, wherein the balloon engages the second stent segment during expansion thereof to maintain its position relative to the delivery catheter and the first segment; and

releasing the second stent segment from the delivery catheter into the body lumen adjacent to the stent segment.

7. A method as in claim 6, wherein inflating the additional portion of the balloon further expands the expanded first stent segment.

8. A catheter system for delivery of a stent to a body lumen comprising:

a stent delivery catheter comprising;

a sheath having a first lumen;

a shaft extending through the first lumen and slidable relative to the sheath;

a stent bumper mounted to the shaft distally of the sheath and movable from a contracted shape to an expanded shape,

wherein the stent bumper comprises a shape memory element adapted to resiliently expand to the expanded shape when unconstrained;

a plurality a self-expanding stent segments carried within the first lumen in a collapsed configuration, the stent segments being adapted to resiliently expand from the collapsed configuration to an expanded configuration,

wherein the stent segments are deployable from the first lumen so as to resiliently expand into the expanded configuration, the stent bumper being expandable independently of the stent segments and configured in the expanded shape to engage a first stent segment during deployment thereof to maintain its position relative to an adjacent stent segment disposed proximal to the first segment; and

a constraining member on the delivery catheter axially movable relative to the stent bumper and adapted to constrain the shape memory element in the contracted shape.

9. A catheter system for delivery of a stent to a body lumen comprising:

a stent delivery catheter comprising;

a sheath having a first lumen;

a shaft extending through the first lumen and slidable relative to the sheath;

a stent bumper mounted to the shaft distally of the sheath and movable from a contracted shape to an expanded shape,

wherein the stent bumper comprises an inflatable balloon,

wherein the balloon comprises an elongate balloon having an axial length at least as long as two stent segments;

a plurality of self-expanding stent segments carried within the first lumen in a collapsed configuration, the stent segments having a plurality of struts defining a plurality of apertures and being adapted to resiliently expand from the collapsed configuration to an expanded configuration,

wherein the stent segments are deployable from the first lumen so as to resiliently expand into the expanded configuration, the stent bumper being expandable independently of the stent segments and configured in the expanded shape to engage a first stent segment without passing through the apertures to maintain the position of the first stent segment relative to the stent delivery catheter; and

an inner sheath disposed over the balloon, wherein the inner sheath is retractable to expose a portion of the balloon to allow it to be inflated from the contracted shape to the expanded shape.

10. A system as in claim 9, wherein the balloon is adapted to be expanded within one or more deployed stent segments to further expand the segments.

11. A system as in claim 10, wherein the balloon in the expanded shape is adapted to further expand the deployed first stent segment.

12. A catheter system for delivery of a stent to a body lumen comprising:

a stent delivery catheter comprising;

a sheath having a first lumen;

a shaft extending through the first lumen and slidable relative to the sheath;

a stent bumper mounted to the shaft distally of the sheath and movable from a contracted shape to an expanded shape,

wherein the stent bumper comprises a shape memory element adapted to resiliently expand to the expanded shape when unconstrained;

a plurality of self-expanding stent segments carried within the first lumen in a collapsed configuration, the stent segments having a plurality of struts defining a plurality of apertures and being adapted to resiliently expand from the collapsed configuration to an expanded configuration,

wherein the stent segments are deployable from the first lumen so as to resiliently expand into the expanded configuration, the stent bumper being expandable independently of the stent segments and configured in the expanded shape to engage a first stent segment without passing through the apertures to maintain the position of the first stent segment relative to the stent delivery catheter; and

a constraining member on the delivery catheter axially movable relative to the stent bumper and adapted to constrain the shape memory element in the contracted shape.