Parallel flow endovascular stent and deployment apparatus therefore

• US 5,403,341 A
• Filed: 01/24/1994
• Issued: 04/04/1995
• Est. Priority Date: 01/24/1994
• Status: Expired due to Term

• Current Assignee: X Technologies, Inc. (Abbott Laboratories)
• Original Assignee: Solar, Rita & Gaterud, Ltd.
• Inventors: Solar, Ronald J.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): Lewis, William W.
• Application Number:
  US08/185,549
• Time in Patent Office: 435 Days
• Field of Search: 606/108, 606/153, 606/191, 606/195, 606/198, 606/200, 623/1, 623/11, 623/12
• US Class Current: 606/198
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• 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

A pressure expandable stent device having a first internal diameter and subsequently expandable to a second internal diameter. The stent device comprises an elongate wire member having first and second ends and a multiplicity of radius bends formed at spaced locations formed along the length thereof. Each of the bends forms an angle of approximately 180° so as to define therebetween multiple straight segments of the wire members which are disposed in generally parallel, convoluted relation to one another. The first and second ends of the wire members are positioned in co-axial alignment and fused to one another. The fusing of the first and second ends of the wire member to each other causes the straight segments to assume a cylindrical array about a longitudinal axis which defines an internal flow channel of the first internal diameter therewithin. The stent device is radially expandable to a configuration where the internal flow channel is of the second internal diameter.

Claims

1. A pressure expandable stent device having a first internal diameter (D1) and subsequently expandable to a second internal diameter (D2), said stent device comprising:

an elongate wire member having first and second ends;

a multiplicity of radius bends formed at spaced locations along said wire member, each of said bends forming an angle of approximately 180°

so as to define therebetween multiple straight segments of said wire member disposed in generally parallel, convoluted relation to one another;

said first and second ends of said wire member being positioned in co-axial alignment and fused to one another;

said straight segments of said wire member thereby assuming a cylindrical array about a longitudinal axis and defining therewithin an internal flow channel of said first internal diameter (D1);

said stent device being radially expandable to a configuration wherein said internal flow channel is of said second internal diameter (D2); and

each of said radius bends having an enlarged, bulbous configuration and said wire member being formed to include weakened portions which are defined between each of said radius bends and the pair of straight segments separated thereby, said bulbous radius bends and said weakened portions being adapted to maintain said straight segments in substantially parallel relation when the stent device is expanded from the first internal diameter (D1) to the second internal diameter (D2).

2. The stent device of claim 1 wherein the angle defined between any pair of said straight segments which are disposed in side-by-side relation and separated by one of said bends does not exceed 45°

when the flow channel is expanded to the second internal diameter.

3. The stent device of claim 1 wherein the angle defined between any pair of said straight segments which are disposed in side-by-side relation and separated by one of said bends does not exceed 30°

when the flow channel is expanded to the second internal diameter.

4. The stent device of claim 1 wherein the first and second ends of said wire member are attached to each other via a weld.

5. The stent device of claim 1 wherein said wire member is fabricated from a titanium alloy.

6. The stent device of claim 1 further in combination with a balloon catheter comprising a catheter body, an inflatable balloon positioned upon said catheter body and an inflation lumen defined within said catheter body for selectively inflating and deflating said balloon, said stent device being extended over said catheter body to a position whereat said balloon is disposed within said flow channel, and radially expandable from the first internal diameter to the second internal diameter by the inflation of said balloon via said inflation lumen.

7. The stent device of claim 6 further in combination with at least one retaining sheath which is extended about one end of said stent device and said catheter body for maintaining said stent device in position upon said balloon, said sheath being adapted to tear under pressure, thus releasing the stent device from engagement to the balloon catheter when the balloon is inflated and the stent device expanded from the first internal diameter to the second internal diameter.

8. The stent device of claim 7 wherein a pair of retaining sheaths are extended about the opposed ends of the stent device and portions of the balloon.

9. The stent device of claim 8 wherein said retaining sheaths are each formed of perforated plastic which is shrunk about the ends of the stent device and portions of the balloon.

10. The stent device of claim 8 wherein said retaining sheaths are each formed of elastomeric material.

11. A pressure expandable stent device having a first internal diameter (D1) and subsequently expandable to a second internal diameter (D2), said stent device comprising:

an elongate wire member having first and second ends;

a multiplicity of radius bends formed at spaced locations along said wire member, each of said bends forming an angle of approximately 180°

so as to define therebetween multiple straight segments of said wire member disposed in generally parallel, convoluted relation to one another;

said first and second ends of said wire member being positioned in co-axial alignment and fused to one another;

said straight segments of said wire member thereby assuming a cylindrical array about a longitudinal axis and defining therewithin an internal flow channel of said first internal diameter (D1);

said stent device being radially expandable to a configuration wherein said internal flow channel is of said second internal diameter (D2); and

each of said radius bends having an enlarged, generally key-shaped configuration and said wire member being formed to include weakened portions which are defined between each of said radius bends and the pair of straight segments separated thereby, said key-shaped radius bends and said weakened portions being adapted to maintain said straight segments in substantially parallel relation when the stent device is expanded from the first internal diameter (D1) to the second internal diameter (D2).

12. The stent device of claim 11 wherein the angle defined between any pair of said straight segments which are disposed in side-by-side relation and separated by one of said bends does not exceed 45°

when the flow channel is expanded to the second internal diameter.

13. The stent device of claim 11 wherein the angle defined between any pair of said straight segments which are disposed in side-by-side relation and separated by one of said bends does not exceed 30°

when the flow channel is expanded to the second internal diameter.

14. The stent device of claim 11 wherein the first and second ends of said wire member are attached to each other via a weld.

15. The stent device of claim 11 wherein said wire member is fabricated from a titanium alloy.

16. The stent device of claim 11 further in combination with a balloon catheter comprising a catheter body, an inflatable balloon positioned upon said catheter body and an inflation lumen defined within said catheter body for selectively inflating and deflating said balloon, said stent device being extended over said catheter body to a position whereat said balloon is disposed within said flow channel, and radially expandable from the first internal diameter to the second internal diameter by the inflation of said balloon via said inflation lumen.

17. The stent device of claim 16 further in combination with at least one retaining sheath which is extended about one end of said stent device and said catheter body for maintaining said stent device in position upon said balloon, said sheath being adapted to tear under pressure, thus releasing the stent device from engagement to the balloon catheter when the balloon is inflated and the stent device expanded from the first internal diameter to the second internal diameter.

18. The stent device of claim 17 wherein a pair of retaining sheaths are extended about the opposed ends of the stent device and portions of the balloon.

19. The stent device of claim 18 wherein said retaining sheaths are each formed of perforated plastic which is shrunk about the ends of the stent device and portions of the balloon.

20. The stent device of claim 18 wherein said retaining sheaths are each formed of elastomeric material.

21. A pressure expandable stent device having a first internal diameter (D1) and subsequently expandable to a second internal diameter (D2), said stent device comprising:

an elongate wire member having first and second ends;

a multiplicity of radius bends formed at spaced locations along said wire member, each of said bends forming an angle of approximately 180°

so as to define therebetween multiple straight segments of said wire member disposed in generally parallel, convoluted relation to one another;

said first and second ends of said wire member being positioned in co-axial alignment and fused to one another;

said straight segments of said wire member thereby assuming a cylindrical array about a longitudinal axis and defining therewith an internal flow channel of said first internal diameter (D1); and

said stent device being radially expandable to a configuration wherein said internal flow channel is of said second internal diameter (D2);

said stent device being used in combination with a balloon catheter comprising an catheter body, an inflatable balloon positioned upon said catheter body and an inflation lumen defined within said catheter body for selectively inflating and deflating said balloon, said stent device being extended over said catheter body to a position whereat said balloon is disposed within said flow channel, and radially expandable from the first internal diameter (D1) to the second internal diameter (D2) by the inflation of said balloon via said inflation lumen;

said stent device being maintained in position upon said balloon by a pair of retaining sheaths which are extended about the opposed ends of the stent device and portions of the balloon, said retaining sheaths being adapted to tear under pressure, thus releasing the stent device from engagement to the balloon catheter when the balloon is inflated and the stent device expanded from the first internal diameter (D1) to the second internal diameter (D2);

said retaining sheaths each being formed of perforated plastic which is shrunk about the ends of the stent device and portions of the balloon.

22. The stent device of claim 21 wherein the angle defined between any pair of said straight segments which are disposed in side-by-side relation and separated by one of said bends does not exceed 45°

when the flow channel is expanded to the second internal diameter.

23. The stent device of claim 21 wherein the angle defined between any pair of said straight segments which are disposed in side-by-side relation and separated by one of said bends does not exceed 30°

when the flow channel is expanded to the second internal diameter.

24. The stent device of claim 21 wherein the first and second ends of said wire member are attached to each other via a weld.

25. The stent device of claim 21 wherein said wire member is fabricated from a titanium alloy.

26. The stent device of claim 21 wherein each of said radius bends has an enlarged, bulbous configuration and said wire member is formed to include weakened portions which are defined between each of said radius bends and the pair of straight segments separated thereby, said bulbous radius bends and said weakened portions being adapted to maintain said straight segments in substantially parallel relation when the stent device is expanded from the first internal diameter to the second internal diameter.

27. The stent device of claim 21 wherein each of said radius bends has an enlarged, generally key-shaped configuration and said wire member is formed to include weakened portions which are defined between each of said radius bends and the pair of straight segments separated thereby, said key-shaped radius bends and said weakened portions being adapted to maintain said straight segments in substantially parallel relation when the stent device is expanded from the first internal diameter to the second internal diameter.

28. The stent device of claim 21 wherein said retaining sheaths are each formed of elastomeric material.

29. A method of inserting a pressure expandable stent into an anatomical passageway, comprising the steps of:

a) providing a stent which comprises;

and elongate wire member having first and second ends; and

a multiplicity of radius bends formed at spaced locations along said wire member so as to define therebetween multiple straight segments of said wire disposed in generally parallel, convoluted relation to one another;

said first and second ends being attached to each other in a manner causing said straight segments to assume a cylindrical array defining therewithin an internal flow channel of a first internal diameter, with said stent device being expandable to a configuration wherein said flow channel is of a second internal diameter;

the size of the stent and the number of convolutions defined thereby being selected such that the expansion of the flow channel to the second internal diameter causes the stent to radially engage the anatomical passageway in a manner wherein the angel defined between any pair of said straight segments which are disposed in side-by-side relation and separated by one of said bends does not exceed 30°

;

b) positioning said stent upon an inflatable balloon while the internal flow channel is of the first internal diameter;

c) inserting the balloon upon which the stent is positioned into said anatomical passageway to a desired treatment cite located therewithin;

d) inflating said balloon to expand said flow channel from said first internal diameter to said second internal diameter whereby said stent radially engages said anatomical passageway to maintain the patency thereof;

e) deflating said balloon to retract the balloon out of contact with said stent; and

f) removing the balloon from the anatomical passageway such that the stent remains operatively positioned therewithin.

30. The method of claim 29 wherein step b) further comprises the step of wrapping the ends of the stent with the sheath material which will tear under pressure-when the balloon is inflated, and step d) further comprises the step of causing the sheath material to tear as the balloon is inflated.

31. The method of claim 29 wherein said method is carried out during an open surgical procedure and step b) further comprises the step of passing the balloon having the stent positioned thereupon through an incision which provides access into the anatomical passageway.

32. The method of claim 29 wherein said method is carried out by percutaneous insertion and step b) further comprises the step of passing the balloon having the stent positioned thereupon percutaneously through a tubular introducer and subsequently transluminally advancing said balloon into said anatomical passageway.

33. The method of claim 29 wherein said anatomical passageway comprises a blood vessel.

34. The method of claim 33 wherein said treatment site is an area of atherosclerotic plaque occlusion.

35. The method of claim 33 wherein said treatment site is a compressed area of said blood vessel.

36. The method of claim 29 wherein said method is carried out subsequent to an angioplasty at the treatment site.

37. The method of claim 36 wherein said method is carried out subsequent to a balloon dilation angioplasty at the treatment site.

38. The method of claim 36 wherein said method is carried out subsequent to an atherectomy procedure at the treatment site.

39. The method of claim 36 wherein said method is carried out subsequent to an ultrasonic ablation procedure at the treatment site.

40. The method of claim 36 wherein said method is carried out subsequent to a laser ablative procedure at the treatment site.

41. A method of inserting a pressure expandable stent into an anatomical passageway, comprising the steps of:

a) providing a stent which comprises;

an elongate wire member having first and second ends; and

a multiplicity of bends formed at spaced locations along said wire member so as to define therebetween multiple straight segments of said wire disposed in generally parallel, convoluted relation to one another;

said first and second ends being attached to each other in a manner causing said straight segments to assume a cylindrical array defining therewithin an internal flow channel of a first internal diameter, with said stent device being expandable to a configuration wherein said flow channel is of a second internal diameter;

b) positioning said stent upon an inflatable balloon while the internal flow channel is of the first internal diameter;

c) inserting the balloon upon which the stent is positioned into said anatomical passageway to a desired treatment site located therewithin;

d) inflating said balloon to expand said flow channel from said first internal diameter to said second internal diameter whereby said stent radially engages said anatomical passageway to maintain the patency thereof;

e) deflating said balloon to retract the balloon out of contact with said stent; and

f) removing the balloon from the anatomical passageway such that the stent remains operatively positioned therewithin;

said method being carried out subsequent to an ultrasonic ablation procedure at the treatment site.

42. The method of claim 41 wherein step b) further comprises the step of wrapping the ends of the stent with the sheath material which will tear under pressure when the balloon is inflated, and step d) further comprises the step of causing the sheath material to tear as the balloon is inflated.

43. The method of claim 41 wherein step a) further comprises the step of selecting the size of the stent and the number of convolutions defined thereby such that the expansion of the flow channel to the second internal diameter causes the stent to radially engage the anatomical passageway in a manner wherein the angle defined between any pair of said straight segments which are disposed in side-by-side relation and separated by one of said bends does not exceed 30°

.

44. The method of claim 41 wherein said method is carried out during an open surgical procedure and step b) further comprises the step of passing the balloon having the stent positioned thereupon through an incision which provides access into the anatomical passageway.

45. The method of claim 41 wherein said method is carried out by percutaneous insertion and step b) further comprises the step of passing the balloon having the stent positioned thereupon percutaneously through a tubular introducer and subsequently transluminally advancing said balloon into said anatomical passageway.

46. The method of claim 41 wherein said anatomical passageway comprises a blood vessel.

47. The method of claim 46 wherein said treatment site is an area of atherosclerotic plaque occlusion.

48. A method of inserting a pressure expandable stent into an anatomical passageway, comprising the steps of:

a) providing a stent which comprises;

an elongate wire member having first and second ends; and

a multiplicity of radius bends formed at spaced locations along said wire member so as to define therebetween multiple straight segments of said wire disposed in generally parallel, convoluted relation to one another;

said first and second ends being attached to each other in a manner causing said straight segments to assume a cylindrical array defining therewithin an internal flow channel of a first internal diameter, with said stent device being expandable to a configuration wherein said flow channel is of a second internal diameter;

b) positioning said stent upon an inflatable balloon while the internal flow channel is of the first internal diameter;

c) inserting the balloon upon which the stent is positioned into said anatomical passageway to a desired treatment site located therewithin;

d) inflating said balloon to expand said flow channel from said first internal diameter to said second internal diameter whereby said stent radially engages said anatomical passageway to maintain the patency thereof;

e) deflating said balloon to retract the balloon out of contact with said stent; and

f) removing the balloon from the anatomical passageway such that the stent remains operatively positioned therewithin;

said method being carried out subsequent to a laser ablative procedure at the treatment site.

49. The method of claim 48 wherein step b) further comprises the step of wrapping the ends of the stent with the sheath material which will tear under pressure when the balloon is inflated, and step d) further comprises the step of causing the sheath material to tear as the balloon is inflated.

50. The method of claim 48 wherein step a) further comprises the step of selecting the size of the stent and the number of convolutions defined thereby such that the expansion of the flow channel to the second internal diameter causes the stent to radially engage the anatomical passageway in a manner wherein the angle defined between any pair of said straight segments which are disposed in side-by-side relation and separated by one of said bends does not exceed 30°

.

51. The method of claim 48 wherein said method is carried out during an open surgical procedure and step b) further comprises the step of passing the balloon having the stent positioned thereupon through an incision which provides access into the anatomical passageway.

52. The method of claim 48 wherein said method is carried out by percutaneous insertion and step b) further comprises the step of passing the balloon having the stent positioned thereupon percutaneously through a tubular introducer and subsequently transluminally advancing said balloon into said anatomical passageway.

53. The method of claim 48 wherein said anatomical passageway comprises a blood vessel.

54. The method of claim 53 wherein said treatment site is an area of atherosclerotic plaque occlusion.