RAPID EXCHANGE INTERVENTIONAL DEVICES AND METHODS

• US 20080097299A1
• Filed: 12/07/2007
• Published: 04/24/2008
• Est. Priority Date: 03/30/2004
• Status: Active Grant

• Current Assignee: JW Medical Systems Ltd
• Original Assignee: XTENT, Inc.
• Inventors: Andreas, Bernard, Grainger, Jeffry
• Granted Patent: US 8,460,358 B2
• Time in Patent Office: Days
• US Class Current: 604/103.04
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 25/0169 Exchanging a catheter while keeping the guidewire in place
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

Wire-guided interventional devices and methods are provided which enable faster and easier catheter exchanges. The interventional devices include a catheter shaft and a guidewire tube wherein the catheter shaft and the guidewire tube each have a length sufficient to extend to the vascular penetration when the interventional device is positioned at the treatment site. In some embodiments, a collar is disposed around the catheter shaft and guidewire tube that automatically inserts or removes the guidewire from the guidewire tube or automatically collapses or extends the guidewire tube as the catheter is introduced or withdrawn.

Claims

1. A method of performing an intervention at a treatment site through a vascular penetration in a vessel, the method comprising:

providing an interventional device having a catheter shaft, an interventional element coupled to a distal extremity of the catheter shaft, and a guidewire tube having a distal portion coupled to the distal extremity of the catheter shaft and a proximal portion separate from the catheter shaft;

placing a distal end of a guidewire through the vascular penetration into the vessel;

inserting a proximal end of the guidewire through at least a portion of the guidewire tube;

positioning the interventional device through the vascular penetration; and

advancing the interventional device through the vessel to position the interventional element at the treatment site, wherein the guidewire is disposed within the guidewire tube between the vascular penetration and the interventional element when the interventional element is at the treatment site.

2. The method of claim 1 wherein the proximal end of the guidewire extends out of a slit in a wall of the guidewire tube.

3. The method of claim 2 wherein the slit extends from a point no more than 50 cm proximal to the interventional element to a point proximal to the vascular penetration when the interventional element is at the treatment site.

4. The method of claim 1 further comprising positioning a collar in the vascular penetration, the collar being slidably disposed over catheter shaft and the guidewire tube, wherein advancing the interventional device comprises moving the catheter shaft and guidewire tube relative to the collar.

5. The method of claim 4 wherein the collar has a wire guide that extends through the slit in the guidewire tube, and wherein moving the guidewire tube relative to the collar guides the guidewire into or out of the guidewire tube.

6. The method of claim 4 further comprising positioning a hemostasis device in the vascular penetration, the collar being positioned in the hemostasis device.

7. The method of claim 6 further comprising providing a hemostatic seal between the hemostasis device and the collar.

8. The method of claim 4 further comprising providing a seal in the collar to inhibit blood leakage from the vessel around the catheter shaft and guidewire tube.

9. The method of claim 1 wherein the guidewire tube is collapsible from an extended length to a collapsed length, the guidewire tube having the collapsed length when the guidewire is inserted therein and having the extended length when the interventional element is at the treatment site.

10. The method of claim 9 further comprising positioning a collar in the vascular penetration, the collar being slidably disposed over catheter shaft, wherein advancing the interventional device comprises moving the catheter shaft relative to the collar.

11. The method of claim 10 wherein the guidewire tube is coupled to the collar such that advancing the interventional device relative to the collar extends the length of the guidewire tube.

12. The method of claim 10 further comprising positioning a hemostasis device in the vascular penetration, the collar being positioned in the hemostasis device.

13. The method of claim 12 further comprising providing a hemostatic seal between the hemostasis device and the collar.

14. The method of claim 1 wherein the interventional element comprises a stent, the method further comprising deploying the stent at the treatment site.

15. The method of claim 1 wherein the interventional element comprises a plurality of stent segments, the method further comprising deploying a first selected number of the stent segments at the treatment site while retaining a second selected number of stent segments on the catheter shaft.

16. The method of claim 1 wherein the interventional element comprises a balloon, the method further comprising expanding the balloon at the treatment site.

17. The method of claim 16 further comprising expanding a first selected portion of the balloon while constraining a second selected portion of the balloon.

18. The method of claim 1 further comprising withdrawing the interventional device from the vessel, wherein the guidewire exits the guidewire tube at locations progressively closer to the interventional element as the interventional device is withdrawn.

19. A method of performing an intervention at a treatment site through a vascular penetration in a vessel, the method comprising:

providing an interventional device having a catheter shaft, an interventional element coupled to a distal extremity of the catheter shaft, and a guidewire tube having a distal portion coupled to the distal extremity of the catheter shaft;

placing a distal end of a guidewire through the vascular penetration into the vessel;

positioning a proximal end of the guidewire through at least a portion of the guidewire tube such that the proximal end of the guidewire exits the guidewire tube at a point closer to a distal end of the interventional device than to a proximal end of the interventional device;

positioning the interventional device through the vascular penetration; and

advancing the interventional device through the vessel to position the interventional element at the treatment site, wherein the guidewire exits the guidewire tube closer to the proximal end of the interventional device than to the distal end of the interventional device when the interventional element is at the treatment site.