Expandable stent delivery sheath and method of use

• US 6,443,979 B1
• Filed: 12/20/1999
• Issued: 09/03/2002
• Est. Priority Date: 12/20/1999
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Voss, Larry, Stalker, Kent C. B.
• Primary Examiner(s): Recla, Henry J.
• Assistant Examiner(s): HO, TAN-UYEN THI
• Application Number:
  US09/469,150
• Time in Patent Office: 988 Days
• Field of Search: 623/1.11, 623/1.12, 623/1-3-, 606/194, 606/108, 606/195, 606/192, 606/123
• 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 expandable delivery sheath is provided for intravascular introduction into a patient'"'"'s vasculature by means of a guiding catheter. An interventional device, such as a stent delivery catheter, is subsequently advanced within the expandable sheath to a point where the stent traverses an arterial lesion. The sheath forms a protective barrier between the lesion and the stent and it delivery catheter, thereby preventing the creation of emboli which might otherwise be produced by abrasion of the stent against the plaque of the arterial lesion. Prior to expansion of the stent, the expandable sheath is retracted from the area of treatment.

Claims

1. A delivery sheath device for use with an interventional device which protects a lesion from abrasion caused by the delivery of the interventional device through the lesion, comprising:

an expandable sheath portion having a proximal end and a distal end, with an inner lumen extending therethrough, the sheath portion having a substantial constant low profile diameter to cross the lesion and being expandable against the lesion by the subsequent introduction of an interventional device into the inner lumen to prevent abrasion between the interventional device and the lesion; and

a catheter portion having a proximal end and a distal end, with an inner lumen extending therethrough, wherein the distal end of the catheter portion is attached to proximal end of the expandable sheath portion and the inner lumen of the catheter portion is used to deliver the interventional device into the inner lumen of the expandable sheath portion, the inner lumen of the catheter portion being larger than the inner lumen of the expandable sheath portion prior to the introduction of the interventional device into the inner lumen of the expandable sheath.

2. The device of claim 1, wherein the expandable sheath portion is elastically expandable.

3. The device of claim 1, wherein the expandable sheath portion is geometrically expandable.

4. The device of claim 1, wherein the expandable sheath portion is elastically and geometrically expandable.

5. The device of claim 1, wherein the expandable sheath portion is of annular cross-section.

6. The device of claim 1, wherein a radiopaque marker is attached to the distal end of the sheath portion.

7. The device of claim 1, wherein the expandable sheath portion is made from an elastomeric material.

8. The device of claim 1, wherein the expandable sheath portion has a foldable cross-section.

9. The device of claim 8, wherein said foldable cross-section includes a plurality of equally spaced radially convex sectors.

10. The device of claim 8, wherein said foldable cross-section includes a plurality of equally spaced spiral arms.

11. The device of claim 1, wherein:

the expandable sheath portion and catheter portion are made from different materials.

12. The device of claim 11, wherein:

the expandable sheath portion is made from a material having greater expandability than the material used for the catheter portion.

13. The device of claim 1, wherein:

the expandable sheath portion has a length at least as long as the length of the lesion to be treated.

14. The device of claim 1, wherein:

the expandable sheath portion is as long as the interventional device used with the delivery sheath device.

15. The device of claim 1, wherein:

the inner lumen of the catheter portion is used to maintain the interventional device in an initial delivery position, the interventional device being positioned near the distal end of the catheter portion while in the initial delivery position, the interventional device being moveable into the expandable sheath portion after the expandable sheath portion crosses the lesion.

16. The device of claim 15, wherein:

the inner lumen of the catheter portion has a diameter which permits the interventional device to extend therethrough without causing expansion of the catheter portion.

17. The device of claim 1, wherein:

the expandable sheath portion is resiliently expandable.

18. A method for providing a protective barrier between a lesion and an intravascular device advanced to the lesion site for treatment of the lesion, comprising the steps of:

percutaneously introducing a guiding catheter and advancing the guiding catheter to a point proximal to the lesion;

providing a radially outwardly expandable sheath having a proximal end and a distal end;

advancing the expandable sheath through the guiding catheter to a point distal of the lesion, whereby the expandable sheath fully traverses the lesion and thereby protects the lesion from abrasion;

providing an intravascular device for treatment of the lesion;

advancing the intravascular device through the expandable sheath until the treatment device is properly positioned for treatment of the lesion, the advancement of the intravascular device within the expandable sheath causing the sheath to expand;

retracting the expandable sheath thereby exposing the intravascular device; and

operating the intravascular device to treat the lesion.

19. The method of claim 18, wherein the expandable sheath is an elastically expandable sheath.

20. The method of claim 18, wherein the expandable sheath is a geometrically expandable sheath.

21. The method of claim 18, wherein the expandable sheath is an elastically and geometrically expandable sheath.

22. The method of claim 18, wherein the intravascular treatment device is a balloon dilatation catheter.

23. The method of claim 18, wherein the intravascular treatment device is a stent and stent-delivery catheter.

24. A method for providing a protective barrier between a lesion and an intervascular device advanced to the lesion site for treatment of the lesion, comprising:

providing an expandable sheath portion having an inner lumen extending therethrough and a catheter portion attached to the expandable sheath portion which includes an inner lumen extending therethrough, the inner lumen of the catheter portion being used to deliver the interventional device into the inner lumen of the expandable sheath portion;

providing an intravascular device for treatment of the lesion;

advancing the intravascular device through the catheter portion into a first delivery position;

advancing the expandable sheath portion across the lesion to provide a protective barrier which protects the lesion from abrasion of the intravascular device;

advancing the intravascular device through the expandable sheath portion causing the expandable sheath portion to expand radially towards the lesion, allowing the intravascular device to be positioned for treatment of the lesion;

retracting the sheath portion to expose the intravascular device; and

operating the intravascular device to treat the lesion.

25. The method of claim 24, wherein the expandable sheath is an elastically expandable sheath.

26. The method of claim 24, wherein the expandable sheath is a geometrically expandable sheath.

27. The method of claim 24, wherein the expandable sheath is an elastically and geometrically expandable sheath.

28. The method of claim 24, wherein:

the intravascular device is a balloon dilatation catheter.

29. The method of claim 24, wherein:

the intravascular device is a stent mounted on a stent delivery catheter.