Stent deployment apparatus and method

• US 6,174,327 B1
• Filed: 02/27/1998
• Issued: 01/16/2001
• Est. Priority Date: 02/27/1998
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Eidenschink, Tracee E. J., Mickley, Timothy J., Mertens, Steven P.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US09/032,620
• Time in Patent Office: 1,054 Days
• Field of Search: 606/108, 606/194, 623/1.11
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve

Abstract

An improved deployment system deploys a stent to maintain the patency of a dilated vessel. The improved stent deployment system is adapted for deployment with a balloon catheter. The stent deployment system includes an expandable stent sheath for supporting the stent for deployment. The stent sheath is movably coupled to a catheter shaft and is relatively short in comparison to the catheter shaft. The stent sheath is movably coupled to the catheter shaft for movement between a retracted position and an advanced deployment position aligned with the balloon for expansion via the balloon for deployment of the stent supported thereby.

Claims

1. In combination:

a catheter including an elongated catheter shaft having a proximal end and a distal end, a balloon supported at the distal end and an inflation lumen extending therethrough and in fluid communication with the balloon; and

a stent deployment device including a tubular member having a proximal and distal end slidably coupleable along the catheter shaft and the tubular member including an expandable stent sheath expandable between a first diameter dimension and a second diameter dimension for deployment of a stent supported thereby, the length of the tubular member being sized so that the length of the balloon is at least approximately as long as the stent sheath and a length of the tubular member between the proximal end and distal end does not extend along a substantial length of the catheter shaft, the proximal end of the tubular member being without circumferential connection to a support tube for operation and use.

2. The combination of claim 1 and further comprising a stent supported and carried by an outer surface of the stent sheath.

3. The combination of claim 1 wherein the stent sheath is formed of an elastic material adapted to expand to a deployment diameter upon application of deployment pressure and sufficiently elastic to collapse to approximately an insertion diameter after deployment pressure is released.

4. The combination of claim 1 wherein the catheter shaft includes a stop ring extending about an outer perimeter thereof, said stop ring being located to define a retracted position for the stent sheath, said stop ring being sized to restrict independent movement of the tubular member thereacross and allowing passage of the tubular member thereacross upon application of sufficient force to the tubular member.

5. The combination of claim 1 wherein the catheter shaft includes a stop ring extending about an outer perimeter thereof, said stop ring being located to position the stent sheath in alignment with the balloon coupled to the catheter shaft for deployment of a stent.

6. The combination of claim 1 wherein the catheter shaft includes a back stop formed of a ring extending about an outer perimeter of the catheter shaft and positioned to limit proximal movement of the tubular member.

7. The combination of claim 1 wherein the stent sheath is formed of a biocompatible material.

8. The combination of claim 1 wherein the tubular member includes a reduced diameter portion to the support the stent sheath along the catheter shaft.

9. A dual function catheter adapted for dilation of an occluded vessel and deployment of an expandable stent comprising:

an elongated catheter shaft having a proximal end and a distal end, and an inflation lumen extending therethrough and a dilation balloon supported at the distal end of the catheter shaft;

an expandable stent sheath, said stent sheath being movably supported relative to the catheter shaft for alignment of the stent sheath relative to the balloon and expandable thereby for deployment of a stent supported thereby; and

a stent sheath shaft fixed to the catheter shaft and the stent sheath is coupled to the stent sheath shaft and movable relative to the catheter shaft.

10. The dual function catheter of claim 9 wherein the stent sheath shaft includes a rigid portion and a collapsible portion to movably support the stent sheath relative to the catheter shaft.

11. A catheter comprising:

a catheter shaft having a balloon supported at a distal end;

a stent sheath expandable for deployment of a stent; and

the catheter shaft including a stent sheath shaft including a rigid portion and an axially collapsible portion to movably support the stent sheath coupled to the stent sheath shaft between a retracted position and an advanced position.

12. The catheter of claim 11 wherein:

the rigid portion includes a proximal and distal end and the proximal end is fixed to a proximal end portion of the catheter shaft; and

the collapsible portion includes a proximal end and a distal end and the proximal end of the collapsible portion is connected to the distal end of the rigid portion.

13. A method for dilating a lesion and deploying a stent comprising the steps of:

providing an elongated catheter shaft having a proximal end and a distal end and a dilation balloon supported at the distal end;

providing a tubular member having a proximal and distal end and including an expandable stent sheath, the tubular member being premounted on the catheter shaft;

inserting the catheter shaft into a patient for treatment and positioning the balloon across a lesion at a treatment site with the expandable stent sheath withdrawn from the balloon and the tubular member supported entirely on a proximal end portion of the catheter shaft;

inflating the balloon;

deflating the balloon;

withdrawing the catheter shaft from the patient;

advancing the stent sheath over the balloon;

advancing the catheter shaft with the stent sheath positioned over the balloon to the treatment site; and

reinflating the balloon to deploy a stent.

14. The method of claim 13 wherein the catheter shaft is withdrawn over a guide wire and the catheter shaft and stent sheath are advanced over the guide wire.

15. The method of claim 13 wherein the stent is crimped down over the balloon.

16. The method of claim 13 including the step of:

hand manipulating the stent sheath to position the stent sheath over the balloon.

17. The method of claim 13 wherein the stent sheath is advanced over the balloon by hand.

18. A catheter comprising:

a catheter shaft having a balloon supported at a distal end and an inflation lumen extending through the catheter shaft and opened to the balloon;

a stent deployment device including a tubular member having a proximal and distal end and an expandable stent sheath;

a push rod connected to the proximal end of the tubular member; and

the catheter shaft including a push rod lumen and the push rod extending through the push rod lumen of the catheter shaft.

19. The catheter of claim 18 wherein the tubular member comprises:

a proximal neck portion.

20. A method for treating a patient comprising steps of:

providing an elongated catheter shaft having a proximal end and a distal end and a dilatation balloon supported at the distal end;

providing a tubular member having a proximal and distal end and an expandable stent sheath;

slidably positioning the tubular member to align with a first stop member spaced from a proximal end portion of the catheter shaft to support the expandable stent sheath spaced from the balloon in a retracted position;

inserting the catheter shaft and expandable stent sheath with the expandable stent sheath in the retracted position into a patient for treatment and advancing the catheter shaft to position the balloon across a lesion at a treatment site;

inflating the balloon while the stent sheath is in the retracted position;

deflating the balloon;

withdrawing the catheter shaft and [expandable stent] tubular member from the patient;

grasping the tubular member proximate to the first stop member and slidably advancing the tubular member to align with a second stop member distally spaced from the first stop member to support the expandable stent sheath in an advanced position with the expandable stent sheath aligned with the balloon;

advancing the catheter shaft and the tubular member aligned with the second stop member to the treatment site; and

reinflating the balloon to deploy a stent.

21. A method for treating a patient comprising steps of:

providing an elongated catheter shaft having a proximal end and a distal end and a dilation balloon supported at the distal end;

providing an expandable stent sheath premounted on the catheter shaft;

inserting the catheter shaft into a patient for treatment and positioning the balloon across a lesion at a treatment site;

inflating the balloon;

deflating the balloon;

withdrawing the catheter shaft from the patient;

grasping the stent sheath and moving the stent sheath over the balloon;

advancing the catheter shaft and the stent sheath to the treatment site; and

reinflating the balloon to deploy a stent.