Edge Protection via Tapered Balloon Wrap

• US 20090312828A1
• Filed: 06/11/2008
• Published: 12/17/2009
• Est. Priority Date: 06/11/2008
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Vrba, Anthony C.
• Granted Patent: US 8,758,422 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61M 2025/1004 Balloons with folds, e.g. folded or multifolded
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1038 Wrapping or folding devices for use with balloon catheters

Abstract

A stent deployment device is provided with a tapered balloon wrap to protect the edge of a crimped stent during stent deployment. The balloon is wrapped unevenly so that the distal end is looser and has a wider circumference than the proximal end of the balloon. With a stent crimped upon such a balloon, the distal balloon end billows out and covers the distal edge of the stent. This shielding billow prevents the stent edge from becoming damaged or causing harm if the stent is distally impacted while traversing body vessels on the way to the deployment site.

Claims

1. A balloon catheter comprising:

a catheter shaft and an expandable balloon, the expandable balloon having an expanded state and an unexpanded state, a proximal end and a distal end, the expandable balloon being positioned around a distal region of the catheter shaft, the expandable balloon having a length, and being defined by a proximal end, a distal end, and a working portion extending therebetween, in the unexpanded state the expandable balloon comprising a collapsed portion disposed about the catheter shaft and at least one wing extending from the collapsed portion, the wing having a wrapped state and an unwrapped state, in the wrapped state the wing is wrapped about the collapsed portion,

wherein the wing in the wrapped state provides a surface of the balloon which extends further outward in a radial direction from the catheter shaft at the distal end of the balloon than at the proximal end of the balloon.

2. The balloon catheter of claim 1, the wing in the unwrapped state extending from the collapsed portion along a wing base which extends parallel to the longitudinal axis of the catheter shaft and has an edge which extends from one end of the wing base to the other end of the wing base wherein in the wrapped state the edge spirals at least part of the way about the longitudinal axis of the catheter along a majority of the length of the edge.

3. The balloon catheter of claim 1, the wing in an unwrapped state extending from the collapsed portion along a wing base which extends parallel to the longitudinal axis of the catheter shaft and having a wing tip which extends parallel to the longitudinal axis of the catheter shaft, wherein, in the wrapped state, the wing base extends parallel to the longitudinal axis of the catheter shaft and the wing tip extends non-parallel to the longitudinal axis of the catheter shaft.

4. The balloon catheter of claim 1, the wing having proximal and distal ends, the proximal end of the wing spiraling more tightly about the collapsed portion than the distal end of the wing.

5. The balloon catheter of claim 1, the catheter further comprising an outer tubular member through which at least a portion of an inner tubular member passes, the proximal end of the balloon being sealingly engaged to the inner tubular member, the distal end of the balloon being sealingly engaged to the outer tubular member.

6. The balloon catheter of claim 5, the inner tubular member further comprising a proximal aperture defining an opening in the inner tubular member through which inflating fluid passes into the balloon, the proximal aperture located closer to the proximal end of the balloon than the distal end of the balloon.

7. The balloon catheter of claim 6, the inner tubular member further comprising a distal aperture distal to the proximal aperture, the distal aperture defining an opening in the inner tubular member smaller than the proximal aperture and through which inflating fluid passes into the balloon.

8. The balloon catheter of claim 6, the inner tubular member further comprising a distal aperture defining an opening in the inner tubular member distal to the proximal aperture through which inflating fluid passes into the balloon, the catheter constructed and arranged to pass fluid into the balloon with greater flux at the proximal aperture than at the distal aperture.

9. The balloon catheter of claim 1, the proximal and distal ends of the balloon having circumferences, the circumference of the distal end of the balloon being greater than the circumference of the proximal end of the balloon.

10. The balloon catheter of claim 1 wherein a distal end of the wing spirals along a clockwise path relative to a distal perspective of the catheter shaft.

11. The balloon catheter of claim 1, wherein a distal end of the wing spirals along a counterclockwise path relative to a distal perspective of the catheter shaft.

12. The balloon catheter of claim 1 further comprising a medical device, wherein in the unexpanded state the medical device is crimped over and around the balloon, in the expanded state the medical device is enlarged and deployed, the medical device selected from the group consisting of stents, grafts, stent-grafts, vena cava filters, expandable frameworks, and any combination thereof.

13. The balloon catheter of claim 12 in which in the unexpanded configuration at least some of the distal end of the balloon billows out from under the distal edge of the medical device to form a shielding bulge which shields the distal edge of the medical device.

14. The balloon catheter of claim 13 in which at least the most distal portion of the medical device is formed in an undulating pattern.

15. A method of deploying a medical device comprising the steps of:

i) providing a medical device crimped about a balloon catheter, the balloon catheter having;

a catheter shaft and an expandable balloon,

the expandable balloon having an expanded state and an unexpanded state, a proximal end and a distal end, the expandable balloon being positioned around a distal region of the catheter shaft, the expandable balloon having a length, the balloon being defined by a proximal end, a distal end, and a working portion extending therebetween, in the unexpanded state the expandable balloon comprising a collapsed portion disposed about the catheter shaft and at least one wing extending from the collapsed portion, the wing wrapped about the collapsed portion

wherein the wing is more tightly wrapped about the collapsed portion at the distal end of the balloon than at the proximal end of the balloon;

ii) positioning the medical device at a position in a patient'"'"'s body; and

iii) inflating the expandable balloon.

16. A balloon catheter comprising:

a catheter shaft and an expandable balloon, the expandable balloon having an expanded state and an unexpanded state, a proximal end and a distal end, the expandable balloon being positioned around a distal region of the catheter shaft, the expandable balloon having a length, the balloon being defined by a proximal end, a distal end, and a working portion extending therebetween, in the unexpanded state the expandable balloon comprising a collapsed portion disposed about the catheter shaft and at least one wing extending from the collapsed portion, the wing wrapped about the collapsed portion

the wing bulging radially outward from catheter shaft at the distal end of the balloon as compared to the proximal end of the balloon.