INTRODUCER FOR ENDOVASCULAR IMPLANTS

• US 20110137403A1
• Filed: 01/18/2011
• Published: 06/09/2011
• Est. Priority Date: 07/18/2008
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Ohlenschlaeger, Bent, Orr, David E., Rasmussen, Erick E., Dierking, William K., Roeder, Blayne A.
• Granted Patent: US 9,161,850 B2
• Time in Patent Office: Days
• US Class Current: 623/1.12
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils

Abstract

An introducer assembly for introducing a stent-graft or other device into a vessel of a patient is provided with a dilator tip which is naturally curved, preferably to be substantially a U-shape. The dilator tip is flexible so as to be able to become substantially straight with a guide wire therein and yet to be able to curve back towards its natural curvature during deployment of an implant. The curvature of the dilator tip can ensure that the dilator tip does not cause damage to the vessel wall during deployment of an implant carried thereon, as can occur with straight dilator tips.

Claims

1. An endovascular introducer assembly, the introducer assembly comprising:

a dilator tip formed of a flexible material having a distal end, a proximal end, and a natural unbiased condition;

a lumen formed within and extending the length of the dilator tip between the distal and proximal ends; and

a guide wire disposed in the lumen, the guide wire comprising,

a distal region adjacent to the distal end,

a proximal region adjacent to the proximal end, and

an intermediate region disposed between the distal and proximal regions,

wherein the dilator tip comprises,

a first biased condition having a first biased radius of curvature when the dilator dip is disposed about the distal region of the guide wire;

a second biased condition having a second biased radius of curvature when the dilator tip is disposed about the proximal region of the guide wire, and

a third biased condition having a third biased radius of curvature when the dilator tip is disposed about the intermediate region of the guide wire, wherein the first biased radius of curvature is less than the third biased radius of curvature, the second biased radius of curvature is between the first and second biased radii of curvatures.

2. The endovascular introducer assembly of claim 1 wherein the distal region of the guide wire is more flexible than the proximal portion of the guide wire.

3. The endovascular introducer assembly of claim 2 wherein the intermediate region has a flexibility between the distal and proximal portions of the guide wire.

4. The endovascular introducer assembly of claim 1 wherein the dilator tip is curved by at least 90°

when in the natural unbiased condition.

6. The endovascular introducer assembly of claim 1 wherein the dilator tip is curved by at least 180°

when in the natural unbiased condition.

7. The endovascular introducer assembly of claim 6 wherein the dilator tip is curved by at least 180°

when in the first biased condition.

8. The endovascular introducer assembly of claim 1, wherein the dilator tip has a length of between 2 and 14 cm.

9. The endovascular introducer assembly of claim 1 wherein the distal region of the guide wire is at least 4 cm.

5. The endovascular introducer assembly of claim 5 wherein the dilator tip is curved by at least 90°

when in the first biased condition.

10. An endovascular introducer assembly, the introducer assembly comprising:

a dilator tip formed of a flexible material having a distal end and a proximal end and having a natural unbiased condition with a curvature of at least 180°

;

a lumen formed within and extending the length of the dilator tip between the distal and proximal ends; and

a guide wire disposed through the lumen, the guide wire comprising,

a distal region having a length of at least 4 cm and adjacent to a distal end,

a proximal region adjacent to the proximal end and having a flexibility less than the distal region, and

an intermediate region disposed between the distal and proximal regions and having a flexibility between the distal region and the proximal region,

wherein the dilator tip comprises,

a first biased condition having a first biased radius of curvature when the dilator tip is disposed about the distal region of the guide wire where the dilator tip is curved by at least 90°

,

a second biased condition having a second biased radius of curvature when the dilator tip is disposed about the proximal region of the guide wire where the dilator dip is not curved by no more than 90°

, and

a third biased condition having a third biased radius of curvature when the dilator tip is disposed about the intermediate region of the guide wire, wherein the first biased radius of curvature is less than the third biased radius of curvature, the second biased radius of curvature is between the first and second biased radii of curvatures.

11. The endovascular introducer assembly of claim 10 wherein the dilator tip is curved by at least 180°

when in the first biased condition.

12. The endovascular introducer assembly of claim 10 wherein the dilator tip has a generally U-shape when in the first biased condition.

13. The endovascular introducer assembly of claim 10 wherein the distal region of the guide wire is more flexible than the dilator tip.

14. The endovascular introducer assembly of claim 10 where the proximal region of the guide wire is less flexible than the dilator tip.

15. The endovascular introducer assembly of claim 10 wherein the distal region of the guide wire is at least as long as the dilator tip.

16. The endovascular introducer assembly of claim 15 wherein when in the second biased condition the dilator tip is substantially linear.

17. A method of deploying an endoluminal device in a patient, including the steps of:

providing an introducer assembly for introducing the endoluminal device into the patient, the assembly including a catheter having a dilator tip with a flexible distal end formed in a curve when in an unbiased condition, and a guide wire having a distal region, a proximal region having a flexibility less than the distal region, and an intermediate region disposed between the distal and proximal regions and having a flexibility between the distal region and the proximal region, where the distal region is more flexible than the dilator tip;

inserting the guide wire into the vasculature of a patient;

placing the guide wire at the treatment site;

feeding the catheter over the guide wire;

placing the catheter at the treatment site;

withdrawing the guide wire;

aligning the distal region of the guide wire with the dilator tip to curve the dilator tip into a substantially U-shape; and

releasing the endoluminal device from the introducer assembly.

18. The method of claim 17 further comprising the step of aligning the dilator tip over the intermediate region to curve the dilator tip into a substantially J-shape.

19. The method of claim 18 further comprising the step of aligning the dilator tip over the proximal region to substantially straighten the dilator top.

20. The method of claim 19 further comprising the step of retracting the introducer assembly from the vasculature of the patient.