Catheter systems and methods for crossing vascular occlusions

• US 20050021002A1
• Filed: 06/10/2004
• Published: 01/27/2005
• Est. Priority Date: 06/10/2003
• Status: Active Grant

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Deckman, Robert K., Francis, Daniel E., Aguilar, Amiel R., Thai, Erik, Clark, Benjamin J., Sparks, Kurt D., Salinas, Sergio
• Granted Patent: US 8,702,679 B2
• Time in Patent Office: Days
• US Class Current: 604/527
• CPC Class Codes: A61B 2017/22042 Details of the tip of the guide wire
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/0687 having means for atraumatic insertion in the body or protection of the tip of the sheath during insertion, e.g. special designs of dilators, needles or sheaths
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

Interventional catheter-based systems and methods are described herein for use in generating an initial pathway through vascular occlusions. The catheter systems generally include two elements. A first element is a Blunt Dissection Catheter including a manually actuated assembly located at the distal tip of the Blunt Dissection Catheter that performs blunt dissection in the vascular occlusion to produce a dissection track, or small pathway through the occlusion. The second element is a Sheath Catheter that serves as a conduit within which the Blunt Dissection Catheter is freely advanced, retracted and rotated. The first and second elements are used in some combination to cross vascular occlusions in both the coronary and peripheral vasculature.

Claims

1. A catheter system comprising:

a catheter shaft including a braided tubular member, wherein at least one inner polymer liner couples to an inside surface of the braided tubular member, wherein at least one outer polymer laminate couples to an outside surface of the braided tubular member, wherein polymer materials of the outer polymer laminate are interspersed through the braided tubular member and connect into interstices of an outside surface of the inner polymer liner; and

at least one lumen in the catheter shaft.

2. The system of claim 1, wherein the outer polymer laminate includes a plurality of polymers that each form one or more sections along a length of the catheter shaft.

3. The system of claim 2, wherein durometer values of the sections decrease longitudinally towards a distal end of the catheter shaft.

4. The system of claim 1, wherein the outer polymer laminate further comprises a plurality of polymers.

5. The system of claim 4, wherein one or more of the polymers have different durometer values, wherein each of the plurality of polymers forms one or more discrete regions of the outer polymer laminate.

6. The system of claim 5, wherein polymers with relatively lower durometer values form discrete regions of a distal end of the outer polymer laminate and polymers with relatively higher durometer values form discrete regions of a proximal end of the outer polymer laminate, wherein distal regions of the catheter shaft have a relatively higher degree of flexibility than proximal regions of the catheter shaft.

7. The system of claim 4, wherein the plurality of polymers includes six polymers.

8. The system of claim 1, wherein a distal termination of the catheter shaft lumen forms an annular opening at a distal end of the catheter shaft.

9. The system of claim 8, wherein the annular opening comprises a polymer forming an atraumatic tip.

10. The system of claim 9, wherein the atraumatic tip is a single polymer having a tapered distal region.

11. The system of claim 9, wherein the atraumatic tip is a single polymer having a rounded distal region.

12. The system of claim 9, wherein the atraumatic tip is comprised of an inner polymer and an outer polymer.

13. The system of claim 1, wherein the catheter shaft includes a fluoroscopic marker system.

14. The system of claim 13, wherein the fluoroscopic marker system includes a first marker region external to the braided tubular member.

15. The system of claim 14, wherein the fluoroscopic marker system includes a second marker region internal to the braided tubular member.

16. The system of claim 1, further comprising a sheath introducer including a member having a proximal and a distal end and forming a single lumen configured to track over a guide wire, wherein the member is configured to be inserted into the catheter shaft, wherein a distal region of the member extends beyond a distal end of the catheter shaft when the member is fully inserted.

17. The system of claim 16, wherein the sheath introducer further comprises at least one hub on the proximal end, the hub configured to lock into a hub on a proximal end of the catheter shaft when the sheath introducer is fully inserted into the catheter shaft.

18. The system of claim 16, wherein the sheath introducer further comprises a fluoroscopic marker system in a distal region of the member.

19. A catheter system comprising:

a catheter shaft including a braided tubular member, wherein at least one inner polymer liner couples to an inside surface of the braided tubular member, wherein at least one outer polymer laminate couples to an outside surface of the braided tubular member, wherein polymer materials of the outer polymer laminate are interspersed through the braided tubular member and connect into interstices of an outside surface of the inner polymer liner, wherein the inner polymer liner forms a lumen in the catheter shaft; and

an introducer including a member having a proximal end and a distal end and forming a single lumen configured to track over a guide wire, wherein the member is configured to be inserted into the catheter shaft, wherein a distal region of the member extends beyond a distal end of the catheter shaft when the member is fully inserted.

20. The system of claim 19, wherein the introducer further comprises at least one hub on the proximal end, the hub configured to lock into a hub on a proximal end of the catheter shaft when the introducer is fully inserted into the catheter shaft.

21. The system of claim 19, wherein at least one of the catheter shaft and the introducer include a fluoroscopic marker system in a distal region of the member.

22. The system of claim 19, wherein the outer polymer laminate further comprises a plurality of polymers.

23. The system of claim 22, wherein one or more of the polymers have different durometer values, wherein each of the plurality of polymers forms one or more discrete regions of the outer polymer laminate.

24. The system of claim 23, wherein polymers with relatively lower durometer values form discrete regions of a distal end of the outer polymer laminate and polymers with relatively higher durometer values form discrete regions of a proximal end of the outer polymer laminate, wherein distal regions of the catheter shaft have a relatively higher degree of flexibility than proximal regions of the catheter shaft.

25. A catheter system comprising:

a sheath catheter comprising a catheter shaft with at least one lumen and terminating to form an annular opening at a distal end of the catheter shaft; and

an intravascular tissue expanding catheter comprising,

a catheter including a distal end and a longitudinal axis having at least one conduit extending along the longitudinal axis;

a housing formed at the distal end of the catheter shaft wherein the housing includes at least one deflecting member defined by a proximal end pivotally coupled to the catheter shaft and a free distal tip that moves through an arc away from the longitudinal axis of the shaft to expand vascular tissue, wherein the at least one deflecting member includes an integrally formed hinge; and

an actuation assembly positioned along the catheter shaft to move the distal tip of at least one deflecting member away from the longitudinal axis of the catheter shaft.

26. The system of claim 25, wherein the at least one deflecting member includes one or more hinges.

27. The system of claim 25, wherein the actuation assembly includes a pulling element coupled to the at least one deflecting member.

28. The system of claim 27, wherein the at least one deflecting member is connected to the housing with at least one hinge pin to form at least one hinge that supports rotation of the at least one deflecting member when the pulling element is pulled in a relatively proximal direction.

29. The system of claim 25, wherein durometer values of materials forming the catheter shaft of the sheath catheter decrease longitudinally towards the distal end.

30. The system of claim 25, wherein the catheter shaft of the sheath catheter further comprises a braided tubular member, wherein at least one inner polymer liner couples to an inside surface of the braided tubular member, wherein at least one outer polymer laminate couples to an outside surface of the braided tubular member, wherein polymer materials of the outer polymer laminate are interspersed through the braided tubular member and connect into interstices of an outside surface of the inner polymer liner.

31. The system of claim 30, wherein the outer polymer laminate includes a plurality of polymers that each form one or more sections along a length of the catheter shaft.

32. The system of claim 31, wherein one or more of the polymers have different durometer values, wherein each of the plurality of polymers forms one or more discrete regions of the outer polymer laminate.

33. The system of claim 32, wherein polymers with relatively lower durometer values form discrete regions of a distal end of the outer polymer laminate and polymers with relatively higher durometer values form discrete regions of a proximal end of the outer polymer laminate, wherein distal regions of the catheter shaft have a relatively higher degree of flexibility than proximal regions of the catheter shaft.

34. The system of claim 25, wherein the annular opening comprises a polymer forming an atraumatic tip.

35. The system of claim 34, wherein the atraumatic tip is a single polymer having a tapered distal region.

36. The system of claim 34, wherein the atraumatic tip is a single polymer having a rounded distal region.

37. The system of claim 34, wherein the atraumatic tip is comprised of an inner polymer and an outer polymer.

38. The system of claim 25, wherein the catheter shaft of the sheath catheter includes a fluoroscopic marker system.

39. The system of claim 38, wherein the fluoroscopic marker system includes at least one of a first marker region external to the braided tubular member and a second marker region internal to the braided tubular member.

40. The system of claim 25, further comprising a sheath introducer including a member having a proximal and a distal end and forming a single lumen configured to track over a guide wire, wherein the member is configured to be inserted into the catheter shaft of the sheath catheter, wherein a distal region of the member extends beyond a distal end of the catheter shaft when the member is fully inserted.

41. The system of claim 40, wherein the sheath introducer further comprises at least one hub on the proximal end, the hub configured to lock into a hub on a proximal end of the catheter shaft of the sheath catheter when the sheath introducer is fully inserted into the catheter shaft.

42. The system of claim 40, wherein the sheath introducer further comprises a fluoroscopic marker system in a distal region of the member.

43. A method of crossing an occlusion, comprising:

assembling a catheter system by loading a blunt dissection catheter into a sheath catheter;

advancing the catheter system to a vascular site and positioning at least one spreading member of the blunt dissection catheter adjacent to the occlusion;

applying a fracturing force to tissue of the blood vessel and the occlusion by moving a distal end of the at least one spreading member laterally away from a longitudinal center line of the blunt dissection catheter by deflecting a distal end of the spreading member around a proximal end of the spreading member in response to a spreading force;

disrupting material of the occlusion and generating a path through the disrupted material in response to the applied fracturing force; and

advancing at least one of the blunt dissection catheter and the sheath catheter through material of the occlusion using the generated path so that at least one of the blunt dissection catheter and the sheath catheter crosses through the material of the occlusion and the material of the occlusion remains external to the catheter system.

44. The method of claim 43, further comprising advancing the sheath catheter past the occlusion before removing the blunt dissection catheter from the blood vessel.

45. The method of claim 43, further comprising advancing a guide wire through the displaced occlusion using the sheath catheter after removing the blunt dissection catheter and before removing the sheath catheter.

46. The method of claim 43, further comprising selecting and advancing a guide wire across the vascular occlusion within the blood vessel.

47. The method of claim 43, further comprising advancing the sheath catheter past the occlusion before removing the blunt dissection catheter and before advancing a guide wire through the sheath catheter.

48. The method of claim 43, further comprising advancing a guide wire across the occlusion using the sheath catheter after advancing the sheath catheter past the occlusion.

49. A method of crossing an occlusion, comprising:

advancing a first guide wire within a blood vessel of vasculature to the occlusion;

assembling a catheter system by loading a sheath introducer into a sheath catheter;

advancing the catheter system over the first guide wire so that a distal end of the system is in proximity to the occlusion;

removing the first guide wire and sheath introducer from the vasculature;

advancing a blunt dissection catheter through the sheath catheter to position at least one spreading member of the blunt dissection catheter adjacent to the occlusion;

applying a fracturing force to tissue of the blood vessel and the occlusion by moving a distal end of the spreading member laterally away from a longitudinal center line of the blunt dissection catheter by deflecting a distal end of the spreading member around a proximal end of the spreading member in response to a spreading force;

disrupting material of the occlusion and generating a path through the disrupted material in response to the applied fracturing force; and

advancing at least one of the blunt dissection catheter and the sheath catheter through material of the occlusion using the generated path so that at least one of the blunt dissection catheter and the sheath catheter crosses through the material of the occlusion and the material of the occlusion remains external to the catheter system.

50. The method of claim 49, further comprising advancing the sheath catheter past the occlusion before removing the blunt dissection catheter from the blood vessel.

51. The method of claim 49, further comprising advancing a second guide wire through the displaced occlusion using the sheath catheter after removing the blunt dissection catheter and before removing the sheath catheter.

52. The method of claim 49, further comprising selecting and advancing a second guide wire across the vascular occlusion within the blood vessel.

53. The method of claim 49, further comprising advancing the sheath catheter past the occlusion before removing the blunt dissection catheter and before advancing a second guide wire through the sheath catheter.

54. The method of claim 49, further comprising advancing a second guide wire across the occlusion using the sheath catheter after advancing the sheath catheter past the occlusion.