Folding of catheter-mounted balloons to facilitate non-rotational radial expansion of intraluminal devices

• US 6,013,092 A
• Filed: 08/18/1998
• Issued: 01/11/2000
• Est. Priority Date: 08/18/1998
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Baxter International Inc.
• Inventors: Saravia, Maria Lilian, Sakata, Misuzu, Dehdashtian, Mark
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Lewis, William W.
• Application Number:
  US09/135,736
• Time in Patent Office: 511 Days
• Field of Search: 606/191, 606/194, 606/198, 606/200, 604/96-101, 623/1, 623/12
• US Class Current: 606/194
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• 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
• CPC Class Codes: A61M 25/1038 Wrapping or folding devices for use with balloon catheters

Abstract

Methods for folding a catheter mounted balloon, and delivery catheter systems which incorporate radially expandable intraluminal devices (e.g., stents, grafts and stented grafts) which are mounted on a balloon folded in accordance with this method. The method comprises generally folding the balloon at least twice, in opposite directions, so that any rotational forces created by the unfolding of the balloon as it is inflated will counteract each other, and will thus avoid substantial rotational movement of the intraluminal device during its radial expansion.

Claims

1. A system for implanting a radially expandable endoluminal device within a luminal anatomical structure, said system comprising:

a catheter having a deflated balloon mounted thereon;

an endoluminal device mounted on said deflated balloon in a radially compact state, said device being radially expandable to an expanded state upon inflation of said balloon;

said balloon being folded by a method which comprises the steps of;

a. forming a plurality of longitudinal furrows in the balloon, said longitudinal furrows defining balloon portions therebetween;

b. folding each balloon portion a first time, in a first direction, to thereby form singly-over-folded balloon portions; and

,

c. folding each balloon portion a second time, in a second direction, to thereby form doubly-over-folded balloon portions.

2. The system of claim 1 wherein the method by which the balloon is folded further comprises the step of:

d. causing the doubly-folded balloon portions to overlap one another.

3. The system of claim 2 wherein the method by which the balloon is folded further comprises the step of:

e. placing a compressive jacket about the doubly-folded, overlapping balloon portions to compress the balloon prior to mounting the radially expandable intraluminal device thereon.

4. The system of claim 3 wherein step e of the method by which the balloon is folded comprises:

helically wrapping a tape about the balloon to form a compressive outer jacket thereon.

5. The system of claim 3 wherein step e of the method by which the balloon is folded comprises:

advancing a tubular sleeve onto said balloon to form a compressive outer jacket thereon.

6. The system of claim 1 wherein the method by which the balloon is folded further comprises the step of:

d. placing a compressive jacket about the doubly-folded balloon portions to compress the balloon prior to mounting of the radially expandable intraluminal device thereon.

7. The system of claim 1 wherein step d of the method by which the balloon is folded comprises:

helically wrapping a tape about the balloon to form a compressive outer jacket thereon.

8. The system of claim 1 wherein step d of the method by which the balloon is folded comprises:

advancing a tubular sleeve onto said balloon to form a compressive outer jacket thereon.

9. The system of claim 1 wherein two longitudinal furrows are formed in the balloon in step a of the balloon folding method, thereby defining first and second balloon portions.

10. The system of claim 1 wherein four longitudinal furrows are formed in the balloon in step a of the balloon folding method, thereby defining first, second, third and fourth balloon portions.

11. The system of claim 1 wherein six longitudinal furrows are formed in the balloon in step a of the balloon folding method, thereby defining first, second, third, fourth, fifth and sixth balloon portions.

12. The system of claim 1 wherein step c of the method by which the balloon is folded further comprises:

flattening of said balloon portions prior to folding said balloon portions for the first time.

13. The system of claim 1 wherein the endoluminal device is a pressure-expandable endoluminal device.

14. The system of claim 13 wherein the radially expandable endoluminal device is selected from the group of radially expandable endoluminal devices consisting of:

stents;

grafts;

stented grafts; and

,

radially expandable intraluminal apparatus.

30. The method of claim 1 further comprising the step of:

d. causing the doubly-folded balloon portions to overlap one another.

31. The method of claim 30 wherein the method further comprises the step of:

e. placing a compressive jacket about the doubly-folded, overlapping balloon portions to compress the balloon prior to mounting the radially expandable intraluminal device thereon.

32. The method of claim 31 wherein step e comprises:

helically wrapping a tape about the balloon to form a compressive outer jacket thereon.

33. The method of claim 31 wherein step e comprises:

advancing a tubular sleeve onto said balloon to form a compressive outer jacket thereon.

34. The method of claim 1 wherein the method further comprises the step of:

d. placing a compressive jacket about the doubly-folded balloon portions to compress the balloon prior to mounting of the radially expandable intraluminal device thereon.

35. The method of claim 34 wherein step d comprises:

helically wrapping a tape about the balloon to form a compressive outer jacket thereon.

36. The method of claim 34 wherein step d comprises:

advancing a tubular sleeve onto said balloon to form a compressive outer jacket thereon.

37. The method of claim 1 wherein two longitudinal furrows are formed in the balloon in step a, thereby defining first and second balloon portions.

38. The method of claim 1 wherein four longitudinal furrows are formed in step a, thereby defining first, second, third and fourth balloon portions.

39. The method of claim 1 wherein six longitudinal furrows are formed in step a, thereby defining first, second, third, fourth, fifth and sixth balloon portions.

40. The method of claim 1 wherein step c further comprises:

flattening of said balloon portions prior to folding said balloon portions for the first time.

15. A system for implanting a radially expandable endoluminal device within a luminal anatomical structure, said system comprising:

a catheter having a deflated balloon mounted thereon;

an endoluminal device mounted on said deflated balloon in a radially compact state, said device being radially expandable to an expanded state upon inflation of said balloon;

said balloon including a sidewall and a plurality of longitudinal furrows formed in the sidewall defining balloon portions therebetween, each balloon portion including two layers of said sidewall and being doubly-over-folded on itself to form a doubly folded portion including eight layers of said sidewall.

16. The system of claim 15 wherein the doubly folded portions overlap one another.

17. The system of claim 15 further including:

a compressive jacket positioned about the doubly folded portions to compress the balloon, enabling mounting of the radially expandable intraluminal device thereon.

18. The system of claim 17 wherein the compressive outerjacket comprises a helically wrapped tape.

19. The system of claim 17 wherein the compressive outerjacket comprises a tubular sleeve.

20. The system of claim 15 wherein there are just two of the longitudinal furrows formed in the balloon, thereby defining first and second balloon portions.

21. The system of claim 15 wherein there are four of the longitudinal furrows formed in the balloon, thereby defining first, second, third and fourth balloon portions.

22. The system of claim 15 wherein there are six of the longitudinal furrows formed in the balloon, thereby defining first, second, third, fourth, fifth and sixth balloon portions.

23. The system of claim 15 wherein the balloon portions are flattened prior to folding them for the first time.

24. The system of claim 15 wherein the balloon portions are folded first in one clock sense to form singly folded portions and then in the other clock sense to form to form the doubly folded portions.

25. The system of claim 24 wherein the singly folded portions are formed by folding the balloon portions in approximately half, and the doubly folded portions are formed by folding the singly folded portions in approximately half.

26. A balloon catheter having a distal region, a deflated balloon attached to the balloon catheter in the distal region of the catheter, the balloon having a thin wall, said balloon further having a plurality of longitudinal furrows along a substantial portion of its length, each of said furrows having adjacent balloon portions on either side of the furrow, said balloon portions being formed of two layers of the thin wall of the balloon, wherein each of said balloon portions is doubled over on itself in a first direction to form an intermediate node configuration, each intermediate node comprising four layers of he wall thickness of the balloon, each intermediate node being further doubled over on itself in a second direction opposite to the first direction to form a final node configuration, with the final node configuration comprising eight layers of the thin wall of the balloon.

27. A balloon angioplasty catheter having a distal section and having an inflatable multifold balloon situated at the catheters distal section, the multifold balloon having a thin wall, the balloon having at its longitudinal center at least three folded nodes when in a compressed state prior to balloon inflation with each folded node comprised of folding of the balloon first in one direction and then the opposite direction so that each one of the at least three folded nodes comprises multiple layers of the thin wall of the balloon.

28. A multifold balloon endoluminal prosthesis delivery catheter comprising;

a balloon catheter having a distal section and having an inflatable multifold balloon situated at the catheters distal section, the multifold balloon having a thin wall, the balloon having at its longitudinal center at least tree folded nodes when in a compressed state prior to balloon inflation with each folded node consisting of folding of the balloon'"'"'s thin wall first in one direction and then the opposite direction so that each one of the at least three folded nodes comprises multiple layers of the thin wall of the balloon; and

,

an endoluminal device placed onto the multifold balloon of the balloon catheter, the endoluminal device configured to have a first radially compact cross section upon placement on the multifold balloon, and a second radially expanded cross section upon inflation of the multifold balloon.

29. A method for folding a catheter mounted balloon which has a generally cylindrical sidewall, and is used to radially expand an intraluminal device which has been mounted on the balloon, said method comprising the steps of:

a. forming a plurality of longitudinal furrows in the balloon, said longitudinal furrows defining balloon portions therebetween; and

,

b. folding each balloon portion a first time, in a first direction, to thereby form singly-over-folded balloon portions;

c. folding each balloon portion a second time, in a second direction, to thereby form doubly-over-folded balloon portions.