Device and Methods for Treatment of Vascular Bifurcations

• US 20080243233A1
• Filed: 02/07/2006
• Published: 10/02/2008
• Est. Priority Date: 02/08/2005
• Status: Abandoned Application

• Current Assignee: B-Balloon Ltd. (Neovasc Incorporated)
• Original Assignee: B-Balloon Ltd. (Neovasc Incorporated)
• Inventors: Miller, Amir, Ben-Muvhar, Shmuel
• Application Number:
  US11/815,652
• Publication Number:
  US 20080243233A1
• Time in Patent Office: Days
• US Class Current: 623/1.35
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/821 Ostial stents
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular

Abstract

A method for treatment of a vascular bifurcation, where a second blood vessel (22) branches from a first blood vessel (24), the first and second blood vessels having characteristic first and second diameters such that the first diameter is greater than the second diameter. The method includes introducing a balloon (30) in the first blood vessel into proximity to the vascular bifurcation. The balloon includes an inner part (32) and a collar (34) proximal to the inner part. The collar is inflated so that the collar expands to an expanded diameter greater than the second diameter but less than an outer diameter of an ostial funnel (26) of the second blood vessel. The balloon is advanced into the second blood vessel so that the inflated collar lodges within the ostial funnel. While the inflated collar is lodged within the ostial funnel, the inner part of the balloon is inflated so as to treat the second blood vessel.

Claims

1. A method for treatment of a vascular bifurcation, where a second blood vessel branches from a first blood vessel, the first and second blood vessels having characteristic first and second diameters such that the first diameter is greater than the second diameter, the method comprising:

introducing a balloon in the first blood vessel into proximity to the vascular bifurcation, the balloon comprising an inner part and a collar proximal to the inner part;

inflating the collar so that the collar expands to an expanded diameter greater than the second diameter but less than an outer diameter of an ostial funnel of the second blood vessel;

advancing the balloon into the second blood vessel so that the inflated collar lodges within the ostial funnel; and

while the inflated collar is lodged within the ostial funnel, inflating the inner part of the balloon so as to treat the second blood vessel.

2. The method according to claim 1, and comprising fitting a stent over the inner part of the balloon, wherein introducing the balloon comprises deploying the stent within the second blood vessel, and wherein inflating the inner part of the balloon causes the stent to expand so that the stent is implanted within the second blood vessel.

3. The method according to claim 2, wherein the stent comprises proximal struts, and wherein inflating the collar causes the proximal struts to expand to a size greater than the second diameter so as to engage the ostial funnel.

4. The method according to claim 3, wherein the expanded struts do not extend into the first blood vessel.

5. The method according to claim 1, wherein introducing the balloon comprises advancing the balloon through the blood vessel using a catheter having a shaft, and inflating the balloon via the shaft, wherein the balloon is formed by fastening the inner part of the balloon around the shaft so as to seal the inner part to the catheter, and fastening the collar around the inner part so as to seal the collar to the inner part.

6. The method according to claim 1, wherein inflating the collar comprises filling the collar with a fluid via a dual-channel manifold, which is also coupled to fill the inner part of the balloon, wherein the manifold is operative to limit a quantity of the fluid with which the collar is filled to a predetermined volume.

7. A method for treatment of a vascular bifurcation, where a second blood vessel branches from a first blood vessel the first and second blood vessels having characteristic first and second diameters such that the first diameter is greater than the second diameter, the method comprising:

fitting a stent over a balloon, which comprises an inner part and a collar proximal to the inner part, the stent comprising proximal struts that extend over the collar;

introducing the balloon, with the stent fitted over the balloon, in the first blood vessel into proximity to the vascular bifurcation;

inflating the collar so as to cause the struts to bend outward to an expanded diameter greater than the second diameter;

advancing the inner part of the balloon, with the stent fitted over the balloon, into the second blood vessel so that the bent struts engage an ostium of the second blood vessel; and

while the bent struts engage the ostium, inflating the inner part of the balloon so as to expand and implant the stent within the second blood vessel.

8. The method according to claim 7, and comprising deflating the collar before the bent struts engage the ostium.

9. The method according to claim 7, wherein introducing the balloon comprises advancing the balloon through the blood vessel using a catheter having a shaft, and inflating the balloon via the shaft, wherein the balloon is formed by fastening the inner part of the balloon around the catheter so as to seal the inner part to the catheter, and fastening the collar around the inner part so as to seal the collar to the inner part.

10. The method according to claim 7, wherein inflating the collar comprises filling the collar with a fluid via a dual-channel manifold, which is also coupled to fill the inner part of the balloon, wherein the manifold is operative to limit a quantity of the fluid with which the collar is filled to a predetermined volume.

11. A method for treatment of a vascular bifurcation, where a second blood vessel branches from a first blood vessel, the first and second blood vessels having characteristic first and second diameters such that the first diameter is greater than the second diameter, the method comprising:

fixing a stent to a distal end of a delivery catheter having an axis, the delivery catheter comprising resilient struts protruding radially outward from the axis at a location proximal to the stent to an expanded diameter greater than the second diameter;

advancing the delivery catheter, with the stent fixed to the distal end thereof, into the first blood vessel through a guiding catheter, thus causing the struts to fold within the guiding catheter in a direction parallel to the axis while the delivery catheter is advanced through the guiding catheter;

introducing the distal end of the delivery catheter, with the stent fixed thereto, distally out of the guiding catheter into proximity to the vascular bifurcation, thus permitting the struts to protrude radially outward from the axis;

advancing the distal end of the delivery catheter, with the stent fitted thereto, into the second blood vessel so that the protruding struts engage an ostium of the second blood vessel; and

while the protruding struts engage the ostium, expanding and implanting the stent within the second blood vessel.

12. The method according to claim 11, wherein fixing the stent comprises fitting the stent over a balloon at the distal end of the delivery catheter, and wherein expanding the stent comprises inflating the balloon.

13. The method according to claim 11, and comprising, after implanting the stent, withdrawing the delivery catheter from the first blood vessel through the guiding catheter, thus causing the struts to fold within the guiding catheter while the delivery catheter is withdrawn.

14. A method for treatment of a vascular bifurcation, where a second blood vessel branches from a first blood vessel, the first and second blood vessels having characteristic first and second diameters such that the first diameter is greater than the second diameter, the method comprising:

fixing a self-expanding stent to a distal end of a catheter having an inflatable collar;

deploying the distal end of the catheter, while holding the stent in a compact state, in the first blood vessel in proximity to the vascular bifurcation;

inflating the collar while the distal end of the catheter is in proximity to the vascular bifurcation so that the collar expands to an expanded diameter greater than the second diameter;

advancing the catheter into the second blood vessel so that the inflated collar engages an ostium of the second blood vessel; and

while the inflated collar engages the ostium, releasing the stent so that the stent expands, thus implanting the stent within the second blood vessel.

15. The method according to claim 14, wherein fixing the self-expanding stent comprises fitting a sleeve over the self-expanding stent so as to hold the stent in the compact state, and wherein releasing the stent comprises withdrawing the sleeve from the second blood vessel while the stent remains within the second blood vessel.

16. The method according to claim 15, wherein withdrawing the sleeve comprises pulling the sleeve through a hub of the collar while the inflated collar engages the ostium.

17. The method according to claim 14, wherein inflating the collar comprises inflating the collar to an expanded diameter greater than the second diameter but less than an outer diameter of an ostial funnel of the second blood vessel, and wherein advancing the catheter comprises advancing the collar into the second blood vessel so that the inflated collar lodges within the ostial funnel.

18. A method for treatment of a vascular bifurcation between first and second blood vessels, the method comprising:

using a catheter, introducing first and second balloon chambers into the first and second blood vessels, respectively, in an area of the bifurcation;

treating the bifurcation by selectively inflating the first and second balloon chambers with a fluid via the catheter using a dual-channel manifold coupled to the catheter; and

configuring the manifold so as to automatically limit a quantity of the fluid with which at least one of the first and second balloon chambers is filled to a predetermined volume.

19. The method according to claim 18, wherein selectively inflating the first and second balloon chambers comprises inflating the first balloon chamber to the predetermined volume, and thereafter inflating the second balloon chamber.

20. The method according to claim 19, and comprising deflating the first and second balloon chambers simultaneously.

21. The method according to claim 18, wherein the first balloon chamber is configured as a collar surrounding a part of the second balloon chamber, and wherein introducing the first and second balloon chambers comprises inserting the second balloon chamber into the second blood vessel, while the part of the balloon surrounded by the collar remains in the first blood vessel, and wherein treating the bifurcation comprises inflating the collar and bringing the inflated collar into engagement with an ostium of the second blood vessel before inflating the second balloon chamber.

22. A method for producing a balloon, comprising:

fastening an inner part of the balloon around the catheter so as to seal the inner part to the catheter; and

forming an inflatable collar around the inner part by fastening a first end of the collar around the inner part so as to seal the collar to the inner part, and fastening a second end of the collar around the catheter so as to seal the collar to the catheter.

23. The method according to claim 22, and comprising providing inflation ports in the catheter through which the inner part and the collar can be independently inflated.

24. The method according to claim 22, wherein fastening the first end of the collar comprises folding the first end inward toward the catheter, and sealing the folded first end to a neck of the inner part of the balloon.

25. A method for treatment of a vascular bifurcation between first and second blood vessels, the method comprising:

fixing first and second balloon chambers to a distal end of a catheter;

fitting a retainer over the first and second balloon chambers;

advancing the distal end of the catheter, while the first and second balloon chambers are contained within the retainer, into a vicinity of the bifurcation;

releasing the first and second balloon chambers from the retainer in the vicinity of the bifurcation; and

after releasing the first and second balloon chambers, deploying and inflating the first and second balloon chambers in the first and second blood vessels, respectively, in order to treat the vascular bifurcation.

26. The method according to claim 25, wherein the retainer comprises a sleeve.

27. The method according to claim 25, wherein the retainer comprises a wire, which is wound around the first and second balloon chambers.

28. The method according to claim 25, wherein releasing the first and second balloon chambers comprises shifting the retainer in a proximal direction relative to the first and second balloon chambers.

29. A method for treatment of a vascular bifurcation where a second blood vessel branches from a first blood vessel, the method comprising:

implanting in the first blood vessel a first stent having a lateral opening, such that the lateral opening is aligned with the second blood vessel;

fitting a second stent over a balloon, which comprises an inner part and a collar proximal to the inner part, the stent comprising proximal struts that extend over the collar;

positioning the balloon, with the second stent fitted over the balloon, in the lateral opening such that the inner part of the balloon protrudes through the lateral opening into the second blood vessel;

inflating the collar within the first blood vessel so as to cause the struts to bend outward and engage the first stent in proximity to the lateral opening, whereby the second stent is positioned at a desired location in the second blood vessel; and

while the bent struts engage the first stent, inflating the inner part of the balloon so as to expand and implant the second stent within the second blood vessel.

30. The method according to claim 29, wherein positioning the balloon comprises inserting a guide wire through the first blood vessel into the second blood vessel via the lateral opening in the first stent, and advancing the balloon over the guide wire.

31. The method according to claim 29, wherein the proximal struts have differing respective lengths, which are chosen responsively to a branching angle of the bifurcation.

32. Apparatus for treatment of a vascular bifurcation, where a second blood vessel branches from a first blood vessel, the first and second blood vessels having characteristic first and second diameters such that the first diameter is greater than the second diameter, the apparatus comprising:

a balloon, comprising an inner part and a collar proximal to the inner part, wherein the collar is coupled to be inflated to an expanded diameter greater than the second diameter but less than an outer diameter of an ostial funnel of the second blood vessel; and

a catheter, which has a distal end to which the balloon is fixed, and which is configured for insertion through the first blood vessel into proximity with the vascular bifurcation and is operable to inflate the collar and to advance the balloon into the second blood vessel so that the inflated collar lodges within the ostial funnel, and to inflate the inner part of the balloon while the inflated collar is lodged within the ostial funnel so as to treat the second blood vessel.

33. The apparatus according to claim 32, and comprising a stent, which is fitted over the inner part of the balloon, wherein inflating the inner part of the balloon causes the stent to expand so that the stent is implanted within the second blood vessel.

34. The apparatus according to claim 33, wherein the stent comprises proximal struts, and wherein inflating the collar causes the proximal struts to expand to a size greater than the second diameter so as to engage the ostial funnel.

35. The apparatus according to claim 34, wherein the expanded struts do not extend into the first blood vessel.

36. The apparatus according to claim 32, wherein the balloon is formed by fastening the inner part of the balloon around the catheter so as to seal the inner part to the catheter, and fastening the collar around the inner part so as to seal the collar to the inner part.

37. The apparatus according to claim 32, wherein the catheter has first and second inflation lumens, which are respectively coupled to the inner part of the balloon and the collar, and comprising a dual-channel manifold, which is coupled via the inflation lumens to fill the collar and the inner part of the balloon with a fluid, wherein the manifold is operative to limit a quantity of the fluid with which the collar is filled to a predetermined volume.

38. Apparatus for treatment of a vascular bifurcation, where a second blood vessel branches from a first blood vessel, the first and second blood vessels having characteristic first and second diameters such that the first diameter is greater than the second diameter, the apparatus comprising:

a balloon, which is fixed to the distal end of the catheter and comprises an inner part and a collar proximal to the inner part;

a stent, which is fitted over the inner part of the balloon and comprises proximal struts that extend over the collar; and

a catheter, which has a distal end to which the balloon is fixed, and which is configured for insertion through the first blood vessel into proximity with the vascular bifurcation and is operable to deploy the balloon, with the stent fitted over the balloon, in the first blood vessel in proximity to the vascular bifurcation, to inflate the collar so as to cause the struts to bend outward to an expanded diameter greater than the second diameter, then to advance the inner part of the balloon, with the stent fitted over the balloon, into the second blood vessel so that the bent struts engage an ostium of the second blood vessel, and to inflate the inner part of the balloon while the bent struts engage the ostium so as to expand and implant the stent within the second blood vessel.

39. The apparatus according to claim 38, wherein the catheter is operative to deflate the collar before the bent struts engage the ostium.

40. The apparatus according to claim 38, wherein the balloon is formed by fastening the inner part of the balloon around the catheter so as to seal the inner part to the catheter, and fastening the collar around the inner part so as to seal the collar to the inner part.

41. The apparatus according to claim 38, wherein the catheter has first and second inflation lumens, which are respectively coupled to the inner part of the balloon and the collar, and comprising a dual-channel manifold, which is coupled via the inflation lumens to fill the collar and the inner part of the balloon with a fluid, wherein the manifold is operative to limit a quantity of the fluid with which the collar is filled to a predetermined volume.

42. Apparatus for treatment of a vascular bifurcation, where a second blood vessel branches from a first blood vessel, the first and second blood vessels having characteristic first and second diameters such that the first diameter is greater than the second diameter, the apparatus comprising:

a stent;

a guiding catheter, which is configured to be introduced into the first blood vessel in proximity to the vascular bifurcation; and

a delivery catheter, which has an axis and a distal end to which the stent is fixed, and which is configured to pass through the guiding catheter into the first blood vessel, and which comprises resilient struts at a location proximal to the stent,

wherein passing the delivery catheter through the guide catheter causes the struts to fold in a direction parallel to the axis, and wherein upon emergence of the distal end of the delivery catheter distally out of the guiding catheter in proximity to the vascular bifurcation, the resilient struts protrude radially outward from the axis and engage an ostium of the second blood vessel while the stent is inserted into the second blood vessel.

43. The apparatus according to claim 42, and comprising a balloon fixed to the distal end of the delivery catheter, where the stent is fitted over the balloon, and wherein the balloon is inflatable so as to expand and implant the stent in the second blood vessel.

44. The apparatus according to claim 42, wherein the delivery catheter is adapted to be withdrawn from the first blood vessel through the guiding catheter, thus causing the struts to fold within the guiding catheter while the delivery catheter is withdrawn.

45. The apparatus according to claim 42, and comprising a sleeve fitted around the delivery catheter so as to hold the resilient struts parallel to the axis while passing the delivery catheter through the guide catheter.

46. Apparatus for treatment of a vascular bifurcation, where a second blood vessel branches from a first blood vessel, the first and second blood vessels having characteristic first and second diameters such that the first diameter is greater than the second diameter, the apparatus comprising:

a self-expanding stent; and

a catheter, having a distal end to which the stent is fixed in a compact state and which is configured for insertion through the first blood vessel into proximity with the vascular bifurcation so that the stent is inserted into the second blood vessel, the catheter comprising an inflatable collar proximal to the distal end,

wherein the catheter is operable to inflate the collar while the distal end of the catheter is in proximity to the vascular bifurcation so that the collar expands to an expanded diameter greater than the second diameter and engages an ostium of the second blood vessel while the stent is released within the second blood vessel so that the stent expands, thus implanting the stent within the second blood vessel.

47. The apparatus according to claim 46, and comprising a sleeve, which is fitted over the self-expanding stent so as to hold the stent in the compact state, wherein the sleeve is withdrawn from the second blood vessel in order to release the stent while the stent remains within the second blood vessel.

48. The apparatus according to claim 47, wherein the catheter is operable to withdraw the sleeve by pulling the sleeve through a hub of the collar while the inflated collar engages the ostium.

49. The apparatus according to claim 46, wherein the collar is inflatable to an expanded diameter greater than the second diameter but less than an outer diameter of an ostial funnel of the second blood vessel, so that the inflated collar lodges within the ostial funnel.

50. Apparatus for vascular treatment, the apparatus comprising:

first and second balloon chambers;

a catheter, having distal and proximal ends and containing first and second lumens coupled respectively to the first and second balloon chambers at the distal end of the catheter; and

a manifold comprising first and second fluid channels coupled respectively to the first and second lumens at the proximal end of the catheter and operative to selectively inflate the first and second balloon chambers with a fluid via the catheter while automatically limiting a quantity of the fluid with which at least one of the first and second balloon chambers is filled to a predetermined volume.

51. The apparatus according to claim 50, wherein the manifold comprises a switch for selecting one of the first and second fluid channels for inflation.

52. The apparatus according to claim 51, wherein the manifold is operative to deflate the first and second balloon chambers simultaneously irrespective of the switch.

53. The apparatus according to claim 50, wherein the manifold comprises a valve, for shutting off a flow of the fluid to the at least one of the first and second balloon chambers, and a flow meter, which is operative to measure the flow through the at least one of the first and second balloon chambers and to actuate the valve when the predetermined volume has passed.

54. The apparatus according to claim 50, wherein the first balloon chamber is configured as a collar surrounding a part of the second balloon chamber.

55. A medical device, comprising:

a catheter having a distal end; and

a dual-chamber balloon fixed to the distal end of the catheter, the balloon comprising;

an inner part, which is fastened around the distal end of the catheter so as to seal the inner part to the catheter; and

an inflatable collar, which is formed around the inner part by fastening a first end of the collar around the inner part so as to seal the collar to the inner part, and fastening a second end of the collar around the catheter so as to seal the collar to the catheter.

56. The device according to claim 55, wherein the catheter contains a lumen and inflation ports through which the inner part and the collar can be independently inflated.

57. The device according to claim 55, wherein the first end of the collar is folded inward toward the catheter and is sealed to a neck of the inner part of the balloon.

58. Apparatus for treatment of a vascular bifurcation between first and second blood vessels, the apparatus comprising:

a catheter having a distal end;

first and second balloon chambers, which are fixed to the distal end of a catheter; and

a retainer, which fits over and contains the first and second balloon chambers while the distal end of the catheter is advanced into a vicinity of the bifurcation, and which is operable to release the first and second balloon chambers in the vicinity of the bifurcation, so that the first and second balloon chambers can be deployed and inflated in the first and second blood vessels, respectively, in order to treat the vascular bifurcation.

59. The apparatus according to claim 58, wherein the retainer comprises a sleeve.

60. The apparatus according to claim 58, wherein the retainer comprises a wire, which is wound around the first and second balloon chambers.

61. The apparatus according to claim 58, wherein the retainer is shifted in a proximal direction relative to the first and second balloon chambers in order to release the first and second balloon chambers.

62. Apparatus for treatment of a vascular bifurcation where a second blood vessel branches from a first blood vessel, the apparatus comprising:

a first stent, which has a lateral opening and is configured to be implanted in the first blood vessel such that the lateral opening is aligned with the second blood vessel;

a balloon, which comprises an inner part and a collar proximal to the inner part;

a second stent, which comprises proximal struts and is fitted over the balloon so that the struts extend over the collar; and

a catheter, having a distal end to which the balloon is fixed, and which is operative to position the balloon, with the second stent fitted over the balloon, in the lateral opening such that the inner part of the balloon protrudes through the lateral opening into the second blood vessel, and to inflate the collar within the first blood vessel so as to cause the struts to bend outward and engage the first stent in proximity to the lateral opening, and to inflate the inner part of the balloon while the bent struts engage the first stent so as to expand and implant the second stent within the second blood vessel.

63. The apparatus according to claim 62, and comprising a guide wire, which is adapted to be inserted through the first blood vessel into the second blood vessel via the lateral opening in the first stent, wherein the catheter is configured to be advanced over the guide wire.

64. The apparatus according to claim 62, wherein the proximal struts have differing respective lengths, which are chosen responsively to a branching angle of the bifurcation.

65. A method using first and second stents for treatment of a vascular bifurcation where a first blood vessel branches from a second blood vessel, the first stent having a lateral opening, the method comprising:

fitting the second stent over a balloon, which comprises an inner part and a collar proximal to the inner part, the stent comprising proximal struts that extend over the collar;

positioning the balloon, with the second stent fitted over the balloon, in the vascular bifurcation so that the inner part of the balloon protrudes into the second blood vessel while the collar is in the first blood vessel;

after positioning the balloon, inflating the collar within the first blood vessel so as to cause the struts to bend outward and engage a wall of the first blood vessel in proximity to the bifurcation, whereby the second stent is positioned at a desired location in the second blood vessel; and

while the bent struts engage the wall of the first blood vessel, inflating the inner part of the balloon so as to expand and implant the second stent within the second blood vessel; and

after implanting the second stent within the second blood vessel, implanting the first stent in the first blood vessel, such that the lateral opening is aligned with the second blood vessel and engages the bent struts.

66. Apparatus for treatment of a vascular bifurcation where a second blood vessel branches from a first blood vessel, the apparatus comprising:

a first stent, which has a lateral opening and is configured to be implanted in the first blood vessel such that the lateral opening is aligned with the second blood vessel;

a balloon, which comprises an inner part and a collar proximal to the inner part;

a second stent, which comprises proximal struts and is fitted over the balloon so that the struts extend over the collar; and

a catheter, having a distal end to which the balloon is fixed, and which is operative to position the balloon, with the second stent fitted over the balloon, in the vascular bifurcation so that the inner part of the balloon protrudes into the second blood vessel while the collar is in the first blood vessel, and to inflate the collar within the first blood vessel so as to cause the struts to bend outward and engage a wall of the first blood vessel in proximity to the bifurcation, whereby the second stent is positioned at a desired location in the second blood vessel, and to inflate the inner part of the balloon while the bent struts engage the wall of the first blood vessel so as to expand and implant the second stent within the second blood vessel,

wherein the first stent is implanted in the first blood vessel after implanting the second stent within the second blood vessel, such that the lateral opening is aligned with the second blood vessel and engages the bent struts.