STENT DELIVERY CATHETER SYSTEM AND METHOD OF IMPLANTING A SELF-EXPANDING STENT WITH EMBOLIC PROTECTION

• US 20080269868A1
• Filed: 04/25/2007
• Published: 10/30/2008
• Est. Priority Date: 04/25/2007
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Fitzgerald, Keif, Tyler, Steven A., Bei, Nianjiong Joan, Lubas, Joanna, Lin, Zhicheng, Saxton, Patrick C.
• Granted Patent: US 7,776,080 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• 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 2230/0006 circular
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

A catheter system and method for implanting an i such as a stent at a treatment site in a patient'"'"'s body lumen. The catheter provides a complete system for stent delivery, dilatation, and delivery and/or recovery of an expandable device, such as an embolic protection device, adjacent to the treatment site in the body lumen.

Claims

1. A method of implanting a self-expanding stent, with embolic protection, in a patient'"'"'s body lumen, comprising:

a) introducing within a patient'"'"'s body lumen a self-expanding stent delivery catheter system having a proximal end, a distal end, an elongated shaft outer member with a lumen extending therein and a stent sheath distal portion, a self-expanding stent radially restrained in a collapsed configuration within the stent sheath distal portion of the shaft outer member, and a balloon catheter dimensioned for relative axial movement within the shaft outer member, the balloon catheter having an elongated shaft with an inflation lumen and a device receiving lumen and a balloon on a distal shaft section with an interior in fluid communication with the inflation lumen such that the balloon is inflatable from a noninflated to an inflated configuration, and advancing the catheter system within the body lumen on a core wire of embolic protection device, with the balloon catheter releasably locked with respect to the shaft outer member in a locked configuration such that the collapsed stent in the stent sheath is coaxially disposed around the noninflated balloon with an inner surface of the stent radially spaced from the outer surface of the noninflated balloon;

b) unlocking and proximally retracting the stent sheath from the collapsed stent and noninflated balloon therein, so that the collapsed stent radially self-expands at a location in the body lumen proximal to an operative distal end of the embolic protection device;

c) inflating the balloon in the radially self-expanded stent, to implant the stent in a fully radially expanded configuration;

d) deflating the balloon, and recovering the embolic protection device by distally advancing the catheter system distally from implanted stent to position the operative distal end of the embolic protection device therein and thereby radially collapse the operative distal end of the embolic protection device; and

e) slidably displacing the catheter system with the outer member releasably locked to the balloon catheter and with the collapsed embolic protection device therein, for repositioning or removal from the patient'"'"'s body lumen.

2. The method of claim 1 wherein the balloon catheter has a radially enlarged delivery distal tip configured to contain at least a portion of the operative distal end of the expandable embolic protection device in a collapsed configuration therein for delivery of the device to the patient'"'"'s body lumen, and including after a) and before b) slidably advancing the balloon catheter, together with the embolic protection device collapsed therein, out the distal end of the stent and stent sheath, and proximally retracting the balloon from the embolic protection device to thereby deliver the embolic protection device by expanding the operative distal end of the embolic protection device in the patient'"'"'s body lumen.

3. The method of claim 2 including inflating the balloon to predilate the body lumen after the embolic protection device is delivered and before the stent is self-expanded.

4. The method of claim 1 wherein the collapsed stent is free within the stent sheath in a non-mounted configuration such that the inner surface of the collapsed stent is exposed to and radially spaced from the outer surface of the balloon, and wherein a stent stop radially protrudes in the outer member lumen at the proximal end of the collapsed stent such that longitudinal displacement of the stent within the outer member proximally of the stent stop is prevented by the stent stop.

5. The method of claim 4 wherein the stent stop is fixedly secured to the balloon catheter and is reversibly radially expandable, and including deploying the stent stop from a collapsed to a radially expanded configuration after a) and before b).

6. The method of claim 1 wherein recovering the embolic protection device comprises advancing the shaft outer member distally to collapse the operative distal end of the device within the stent sheath distal portion of the shaft outer member.

7. The method of claim 6 wherein the shaft outer member is advanced distally over the deflated balloon and then locked with respect to the balloon catheter before being distally advanced over the operative distal end of the device to collapse the device at a location within the shaft outer member distal to the balloon.

8. The method of claim 1 wherein recovering the embolic protection device comprises advancing the balloon catheter distally to collapse the operative distal end of the device within a radially enlarged recovery distal tip of the balloon catheter elongated shaft.

9. A stent delivery catheter system, comprising:

a) an elongated shaft outer member having a lumen extending therein and a stent sheath distal portion, and a self expanding stent which is radially restrained in a collapsed configuration within the stent sheath distal portion and which radially expands from the collapsed configuration to an expanded configuration upon release of the radially restraining force of the stent sheath distal portion of the shaft outer member; and

b) a balloon catheter dimensioned for relative axial movement within the shaft outer member, which has an elongated shaft having an inflation lumen and a device receiving lumen, and a balloon on a distal shaft section having an interior in fluid communication with the inflation lumen such that the balloon is inflatable from a noninflated to an inflated configuration, and which is releasably locked with respect to the shaft outer member and slidably disposed therein in an unlocked configuration, wherein the collapsed stent in the stent sheath is coaxially disposed around the noninflated balloon and has an inner surface radially spaced from the outer surface of the noninflated balloon.

10. The catheter system of claim 9 wherein the collapsed stent is free within the stent sheath in a non-mounted configuration such that the inner surface of the collapsed stent is exposed to and radially spaced from the outer surface of the balloon.

11. The catheter system of claim 10 including a stent stop radially protruding in the outer member lumen, configured to prevent longitudinal displacement of the stent within the outer member proximally of the stent stop.

12. The catheter system of claim 11 wherein the stent stop is fixedly secured to the balloon catheter and is reversibly radially expandable to deploy from a collapsed to a radially expanded configuration.

13. The catheter system of claim 9 wherein the balloon catheter has a radially enlarged delivery distal tip configured to releasably contain at least a portion of an expandable embolic protection device in a collapsed configuration therein.

14. The catheter system of claim 9 wherein the stent sheath has an inner diameter dimensioned to be slidably advanceable distally past the deflated balloon.

15. The catheter system of claim 9 wherein the balloon catheter has a radially enlarged recovery distal tip configured to slidably receive at least a portion of an expanded embolic protection device to collapse and thereby recover the device therein.

16. The catheter system of claim 9 wherein the shaft outer member has a distal port at the distal end thereof, and a rapid-exchange proximal port distally spaced from a proximal end of the outer member, which are configured to slidably receive a device therein.

17. The catheter system of claim 16 wherein the balloon catheter is a rapid-exchange catheter, so that the device receiving lumen of the balloon catheter extends from a distal port at the distal end of the balloon catheter to a proximal port distally spaced from a proximal end of the balloon catheter shaft and is configured to slidably receive a wire therein, and the balloon catheter extends within a proximal and a distal section of the shaft outer member to the proximal end of the shaft outer member.

18. The catheter system of claim 17 wherein a proximal adapter handle on the proximal end of the catheter system releasably locks the balloon catheter to the outer member.

19. The catheter system of claim 16 wherein the balloon catheter is an over-the-wire catheter, so that the device receiving lumen of the balloon catheter extends from a distal port at the distal end of the balloon catheter to a proximal port at a proximal end of the balloon catheter shaft, and the balloon catheter extends within a distal section of the outer member, and extends exterior to a proximal section of the outer member located proximal to the rapid-exchange proximal port of the outer member.

20. The catheter system of claim 9 wherein the shaft outer member and the balloon catheter are both over-the-wire catheters, so that the device receiving lumen of the balloon catheter extends from a distal port at the distal end of the balloon catheter to a proximal port at a proximal end of the balloon catheter shaft, and the balloon catheter extends within a proximal and a distal section of the shaft outer member to the proximal end of the shaft outer member.