Self-expanding stent delivery system

• US 6,077,295 A
• Filed: 07/15/1996
• Issued: 06/20/2000
• Est. Priority Date: 07/15/1996
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Limon, Timothy A., Saunders, Richard J.
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US08/680,429
• Time in Patent Office: 1,436 Days
• Field of Search: 606/1, 606/108, 606/191-200, 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 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• 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 2210/0033 electrically, e.g. heated by resistor
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters

Abstract

A stent-delivery catheter system delivers and implants a self-expanding stent intraluminally into a human patient'"'"'s body lumen. A self-expanding stent is removabaly attached to the distal end of an inner member so that attachment projections prevent axial movement of the stent on the inner member while the stent is being delivered and implanted in a patient'"'"'s body lumen.

Claims

1. A catheter assembly comprising:

an elongated catheter having a proximal end and a distal end;

the catheter having an inner member and an outer member extending along a longitudinal axis, the inner member and the outer member having a coaxial configuration and dimensioned for relative axial movement;

means for providing relative axial movement between the inner member and the outer member;

a self-expanding stent having an open lattice structure configured to be biased from a delivery configuration having a reduced cross section and a predetermined length to an open configuration with an enlarged cross section and being positioned within a distal end of the outer member in the delivery configuration; and

a plurality of attachment projections at a distal end of the inner member spaced along the stent a distance at least as great as the predetermined length for facilitating the removable attachment of the stent to the inner member distal end.

2. The catheter assembly of claim 1, wherein the attachment projections are formed from a heat-deformable polymeric material at the distal end of the inner member.

3. The catheter assembly of claim 2, wherein the polymeric material on the distal end of the inner member is taken from the group of polymeric materials including polyurethanes, polyethylenes, polyethylterpthalate, and nylons.

4. The catheter assembly of claim 1, wherein the means for providing relative axial movement between the inner member and the outer member includes a control handle positioned at the proximal end of the elongated catheter.

5. The catheter assembly of claim 1, wherein the self-expanding stent is formed from a metal alloy taken from the group of metal alloys including stainless steel, nickel-titanium, and tantalum.

6. The catheter assembly of claim 1, wherein the inner member of the elongated catheter has a through lumen for receiving a guide wire so that the elongated catheter can be positioned within a body lumen by advancing it over the guide wire.

7. The catheter assembly of claim 1, wherein the inner member of the elongated catheter has a side port for receiving a guide wire, the side port being positioned so that the catheter can be rapidly exchanged.

8. The catheter assembly of claim 1, wherein the distal end of the elongated catheter includes an elastomeric sleeve attached to the distal end, the elastomeric sleeve adapted to conform and fill the lattice structure of the self-expanding stent with the plurality of attachment projections.

9. A method of mounting an intravascular stent on a delivery catheter, the method comprising:

providing a delivery catheter having an elongated catheter body and a proximal end and a distal end, the catheter having an inner member and an outer member extending along a longitudinal axis, the inner member and the outer member having a coaxial configuration and dimensioned for relative axial movement, and control handles for providing relative axial movement between the inner member and the outer member;

positioning a self-expanding stent in a delivery configuration having an open lattice structure a reduced cross section and a predetermined length within an inner lumen of the outer member;

manipulating the control handles to slide the inner member distal end within an inner lumen of the self-expanding stent; and

heating the inner member distal end so that it conforms and fills the open lattice structure of the self-expanding stent with a plurality of attachment projections spaced along the stent a distance at least as great as the predetermined length thereby removably attaching the self-expanding stent to the inner member distal end.

10. A method of implanting a self-expanding stent in a body lumen, the method comprising:

providing an elongated catheter having a proximal end and a distal end, the catheter having an inner member and an outer member extending along a longitudinal axis, the inner member and the outer member having a coaxial configuration and dimensioned for relative axial movement, the inner member distal end encircled by a self-expanding stent in a delivery configuration having a reduced cross section and a predetermined length, the inner member capable of being heated whereby it conforms and fills an open lattice structure of the self-expanding stent with a plurality of attachment projections, the projections spaced along the stent a distance at least as great as the predetermined length, control handles for providing relative axial movement between the inner member and the outer member, and the distal end of the outer member forming a sheath around the self-expanding stent;

manipulating the control handles to simultaneously move the inner member axially in a distal direction and the outer member axially in a proximal direction;

deploying the stent by permitting it to self-expand radially outwardly into contact with the body lumen while preventing axial movement of the stent on the catheter by a plurality of the attachment projections; and

withdrawing the catheter from the body lumen.

11. The method of implanting a stent of claim 10, the method further comprising the deploying and withdrawing steps further including:

positioning the distal end of the catheter at the site for implanting the stent;

manipulating the control handles to simultaneously move the inner member axially in a distal direction and the outer member axially in a proximal direction to begin implanting the stent;

manipulating the control handles to simultaneously move the inner member axially in a proximal direction and the outer member axially in a distal direction to recapture the stent and to position the stent on the inner member distal end;

repositioning the catheter distal end to implant the stent;

manipulating the control handles to simultaneously move the inner member axially in a distal direction and the outer member axially in the proximal direction to release the stent to self-expand in the body lumen; and

withdrawing the catheter from the body lumen.

12. A method of implanting a self-expanding stent in a body lumen, the method comprising:

providing an elongated catheter having a proximal end and a distal end, the catheter having an inner member and an outer member extending along a longitudinal axis, the inner member and the outer member having a coaxial configuration and dimensioned for relative axial movement, the inner member distal end encircled by a self-expanding stent in a delivery configuration having an open lattice structure, a reduced cross section and a predetermined length, the inner member capable of being heated whereby it conforms and fills the open lattice structure of the self-expanding stent with a plurality of attachment projections, the projections spaced along the stent a distance at least as great as the predetermined length, control handles for providing relative axial movement between the inner member and the outer member, the distal end of the outer member forming a sheath around the self-expanding stent;

manipulating the control handles to move the outer member axially in a proximal direction while maintaining the inner member stationary;

deploying the stent by permitting it to self-expand radially outwardly into contact with the body lumen; and

withdrawing the catheter from the body lumen.

13. The method of implanting a stent of claim 12, the method further comprising, prior to said withdrawing step:

positioning the distal end of the catheter at the site for implanting the stent;

manipulating the control handles to simultaneously move the inner member axially in a proximal direction and the outer member axially in a distal direction to recapture the stent;

repositioning the catheter distal end to implant the stent;

manipulating the control handles to move the outer member axially in the proximal direction to release the stent to self-expand in the body lumen while simultaneously holding the inner member stationary; and

withdrawing the catheter from the body lumen.