Stent delivery system

• US 5,782,855 A
• Filed: 04/10/1996
• Issued: 07/21/1998
• Est. Priority Date: 01/28/1991
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Khosravi, Farhad, Lau, Lilip, Hartigan, William M., Sigwart, Ulrich, Klemm, Kurt R.
• Primary Examiner(s): STRIGHT, RONALD K
• Application Number:
  US08/630,528
• Time in Patent Office: 832 Days
• Field of Search: 606/192, 606/194, 606/198, 606/195, 606/108, 606/191, 623/1, 623/11, 623/12, 604/96, 604/102, 604/104, 604/160, 604/161, 604/171, 604/264, 604/280, 604/49, 604/52, 128/772, 128/656, 128/657-658, 600/433-435, 600/585
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths

Abstract

The invention is directed to a stent delivery method and system which generally includes an elongated delivery sheath and a catheter disposed within an outer lumen of the sheath having an expandable member on its distal extremity. An expandable stent is mounted on the expandable member of the catheter. The distal portion of the sheath tapers down and is tucked within an elastic cone during transport of the stent to a stenotic region. A manipulating device is provided on the proximal end of the delivery system to effect relative axial movement between the sheath and the catheter so as to expose the stent mounted on the expandable member on the catheter within a body lumen such as a coronary artery and allow the expansion of the stent by the expansion of the expandable member. The elastic cone thereby disengages from the sheath and collapses about the distal end of the catheter. The delivery sheath has a first port in its distal end and a second port in the sheath wall proximally disposed from the distal end of the sheath. The catheter likewise has a first port in its distal end and a second port proximally disposed from the distal end of the catheter. An inner lumen extends within the distal portion of the catheter between the first and second ports and slidably receives a guiding member such as a guidewire. This system allows the stent to be delivered over a guidewire previously advanced to the desired location within a body lumen.

Claims

1. A stent delivery system for delivering a stent within a body lumen, comprising:

an elongated sheath having proximal and distal ends and a wall therebetween, an outer lumen extending therein between said proximal and distal ends, a first port in the distal end, a second port in the proximal end and a side port spaced proximally from the distal end, said ports being in fluid communication with the outer lumen, the sheath having a slit formed in said wall extending between the first port and side port thereof;

an elongated catheter disposed within the outer lumen of the sheath having proximal and distal ends, an expandable member proximally adjacent to the distal end of the catheter which is to receive on the exterior thereof an expandable stent, an inner lumen which is to receive a guide wire therein and which extends between a first port and a side port of the catheter; and

means to adjust the relative axial positions of the catheter and the sheath to expose the expandable member so that upon the expansion thereof an expandable stent disposed about the expandable member will thereby be expanded.

2. The stent delivery system of claim 1, wherein the catheter has a wall with a slit therein extending from the side port to a location proximal to the expandable member.

3. A stent delivery system for the delivery of an expandable stent within a body lumen, comprising:

an elongated sheath having proximal and distal ends and a wall therebetween, an outer lumen extending therein between said proximal and distal ends, a first port in the distal end, a second port in the proximal end and a side port spaced proximally from the distal end, said ports being in fluid communication with the outer lumen;

the sheath having a slit in said wall extending between the first port and the side port;

an elongated catheter disposed within the outer lumen of the sheath having proximal and distal ends, an expandable member adjacent to the distal end of the catheter for receiving on the exterior thereof an expandable stent, and an inner lumen for slidably receiving a guide wire therein, said inner lumen extending between a first port in the distal end of the catheter and a side port spaced proximally from the distal end of the catheter, both of the ports being in fluid communication with said inner lumen of the catheter, said elongated catheter being coaxially aligned within the outer lumen; and

means to adjust the relative axial positions of the catheter and sheath to expose the expandable member on the catheter.

4. The stent delivery system of claim 3, wherein the means to adjust the relative axial positions of the catheter and the sheath includes a manipulator located at the proximal ends of said sheath and said catheter, comprising:

an elongated manipulator housing have proximal and distal ends and an interior chamber;

a cap having a threaded passageway therethrough and which is rotatably mounted on an end of the elongated manipulator housing; and

a longitudinally movable drive member which has a threaded exterior, which is disposed at least partially within the interior chamber of the elongated manipulator housing and which has a distal end extending through a central passageway of the cap, rotation of the cap causing axial movement of the drive member and exposing said expandable member.

5. The stent delivery system of claim 4, wherein the longitudinally movable drive member has a central passageway which receives the proximal end of the catheter.

6. The stent delivery system of claim 5, wherein the proximal end of the catheter is fixed to the manipulator housing.

7. The stent delivery system of claim 5, wherein the sheath is fixed to the distal end of the longitudinally movable drive member which extends out the distal end of the manipulator housing.

8. The stent delivery system of claim 3, wherein the catheter has a wall with a slit therein extending from the side port to a location proximal to the expandable member.

9. A method of delivering an expandable stent to a desired location within a patient'"'"'s body lumen which has a guide wire disposed therein with a proximal end extending out of the patient, the method comprising:

providing an elongated sheath having proximal and distal ends and a wall therebetween, a first port in the distal end of said sheath, a second port in the proximal end of said sheath and a side port spaced proximally from said distal end;

an elongated catheter disposed within said elongated sheath having proximal and distal ends, a first port in the distal end of said elongated catheter and a side port spaced proximally from said distal end of the elongated catheter, the catheter having an expandable member proximally adjacent to the distal end of the catheter and having mounted on the exterior thereof an expandable stent, the catheter having an inner lumen to slidably receive a guide wire therein;

adjusting the relative axial positions of the elongated sheath and the catheter so as to at least partially align the side port of the elongated sheath and side port of the elongated catheter;

providing a guide wire at the desired location within a patient'"'"'s body;

positioning the guide wire so that a portion of the guide wire extends through the side port of the elongated sheath and side port of the elongated catheter;

advancing the sheath and the catheter over the guide wire through the body lumen to the desired location therein;

adjusting the relative axial positions of the sheath with respect to the catheter to expose the expandable stent on the expandable member;

inflating the expandable member to thereby expand the stent mounted thereon at the desired location within the body lumen;

after the expandable stent has been implanted, deflating the expandable member on the catheter; and

withdrawing the catheter and the sheath from the body lumen.

10. The method of claim 9, wherein the expandable member is a balloon and wherein inflation fluid is directed to the interior of the balloon to expand the balloon and thereby expand the stent mounted thereon.

11. The method of claim 9, wherein the expandable stent engages the wall defining the body lumen when the stent is expanded so as to maintain the patency thereof.