Coronary vein navigator

• US 20040039371A1
• Filed: 08/23/2002
• Published: 02/26/2004
• Est. Priority Date: 08/23/2002
• Status: Abandoned Application

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation), Guidant Corporation (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Tockman, Bruce, Westlund, Randy, Hall, Jeffrey A.
• Application Number:
  US10/226,647
• Publication Number:
  US 20040039371A1
• Time in Patent Office: Days
• US Class Current: 604/528
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0152 with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

A system and method for navigating coronary vasculature involves use of a guide catheter system which includes a guide catheter, a navigator catheter longitudinally displaceable within the guide catheter, and a deflection arrangement provided at a distal end of the navigator catheter. The guide catheter is advanced to at least a patient'"'"'s coronary sinus ostium, and the navigator catheter is extended from the guide catheter to a location proximate or within an angled vein distal to the coronary sinus ostium. Using the deflection arrangement, a guide wire passing through the navigation catheter is directed into the angled vein. A lead having an open lumen is advanced over the guide wire to direct the lead to an implant site within the angled vein.

Claims

1. A guide catheter system, comprising:

a guide catheter comprising a flexible shaft defining a longitudinal axis and having a proximal end, a distal end, and a main lumen;

a navigator catheter having a proximal end, a distal end, and a central lumen, the navigator catheter longitudinally displaceable within the main lumen of the guide catheter, the distal end of the navigator catheter dimensioned for passage into an angled vein distal to a patient'"'"'s coronary sinus ostium, the central lumen dimensioned to receive a longitudinally displaceable guide wire; and

a deflection arrangement provided at the distal end of the navigator catheter for directing the guide wire into the angled vein, the deflection arrangement imparting a bend at the distal end of the navigator catheter having an angle sufficient to facilitate passage of the distal end of the navigator catheter into the angled vein.

2. The system of claim 1, wherein the bend angle is an acute angle relative to a longitudinal axis of the navigator catheter proximal of the deflection arrangement.

3. The system of claim 1, wherein the bend angle is an obtuse angle relative to a longitudinal axis of the navigator catheter proximal of the deflection arrangement.

4. The system of claim 1, wherein the bend angle ranges between about 0 degrees and about 180 degrees relative to a longitudinal axis of the navigator catheter proximal of the deflection arrangement.

5. The system of claim 1, wherein the deflection arrangement comprises a pre-formed region of the distal end of the navigator catheter, the pre-formed region assuming the bend angle when the pre-formed region extends beyond the distal end of the guide catheter.

6. The system of claim 5, wherein the pre-formed distal end of the navigator catheter is more flexible than the distal end of the guide catheter.

7. The system of claim 1, wherein the distal end of the guide catheter comprises a pre-formed region.

8. The system of claim 1, wherein the deflection arrangement comprises a deflection mechanism that imparts the bend angle, the deflection mechanism controllable from the proximal end of the navigator catheter.

9. The system of claim 8, wherein the deflection mechanism comprises a deflection tendon attached at or proximate a distal tip of the navigator catheter and extending to the proximal end of the navigator catheter.

10. The system of claim 9, wherein a plurality of bend angles are developed upon application of forces to the deflection tendon.

11. The system of claim 1, wherein the deflection arrangement comprises a flexible region at the distal end of the navigator catheter and a shaping member longitudinally displaceable within the central lumen of the navigator catheter, the flexible region assuming the bend angle as the shaping member passes into the flexible region.

12. The system of claim 11, wherein the shaping member comprises a shaping wire.

13. The system of claim 11, wherein the shaping member comprises a stylet.

14. The system of claim 1, wherein the deflection arrangement comprises an inflation member encompassing at least part of the distal end of the navigator catheter, an inflation lumen of the navigator catheter fluidly coupling the inflation member with an inflation mechanism provided at the proximal end of the navigator catheter, the inflation mechanism selectably pressurizing and depressurizing a fluid within the inflation lumen to respectively inflate and deflate the inflatable member to develop a desired bend angle.

15. The system of claim 1, wherein the guide catheter has an outer diameter of about 10 French or less, and the navigator catheter has an outer diameter of about 8 French or less.

16. The system of claim 1, wherein the guide catheter comprises a longitudinal pre-stress line extending between the distal and proximal ends of the guide catheter, the guide catheter splitting along the longitudinal pre-stress line upon guide catheter retraction in a proximal direction.

17. The system of claim 1, wherein the central lumen of the navigation catheter is configured to receive a contrast media for mapping vasculature.

18. A guide catheter system, comprising:

a guide catheter comprising a flexible shaft defining a longitudinal axis and having a proximal end, a distal end, and a main lumen;

a navigator member having a proximal end and a distal end, the navigator member longitudinally displaceable within the main lumen of the guide catheter, the distal end of the navigator member dimensioned for passage into an angled vein distal to a patient'"'"'s coronary sinus ostium; and

a deflection arrangement provided at the distal end of the navigator member, the deflection arrangement imparting a bend at the distal end of the navigator member having an angle sufficient to facilitate passage of the distal end of the navigator member into the angled vein.

19. The system of claim 18, wherein the bend angle is an acute angle relative to a longitudinal axis of the navigator catheter proximal of the deflection arrangement.

20. The system of claim 18, wherein the bend angle is an obtuse angle relative to a longitudinal axis of the navigator catheter proximal of the deflection arrangement.

21. The system of claim 18, wherein the bend angle ranges between about 0 degrees to about 180 degrees relative to a longitudinal axis of the navigator catheter proximal of the deflection arrangement.

22. The system of claim 18, wherein the deflection arrangement comprises a pre-formed region of the distal end of the navigator member, the pre-formed region assuming the bend angle when the pre-formed region extends beyond the distal end of the guide member.

23. The system of claim 18, wherein the distal end of the guide catheter comprises a pre-formed region.

24. The system of claim 18, wherein the navigator member comprises a navigator catheter and the deflection arrangement comprises a deflection mechanism that imparts the bend angle, the deflection mechanism controllable from the proximal end of the navigator member.

25. The system of claim 24, wherein the deflection mechanism comprises a deflection tendon attached at or proximate a distal tip of the navigator catheter and extending to the proximal end of the navigator catheter.

26. The system of claim 25, wherein a plurality of bend angles are developed upon application of forces to the deflection tendon.

27. The system of claim 18, wherein the navigator member comprises a navigator catheter, and the deflection arrangement comprises a flexible region at the distal end of the navigator catheter and a shaping member longitudinally displaceable within a central lumen of the navigator catheter, the flexible region assuming the bend angle as the shaping member passes into the flexible region.

28. The system of claim 27, wherein the shaping member comprises a shaping wire.

29. The system of claim 27, wherein the shaping member comprises a stylet.

30. The system of claim 18, wherein the navigator member comprises a navigator catheter and the deflection arrangement comprises an inflation member encompassing at least part of the distal end of the navigator catheter, an inflation lumen of the navigator catheter fluidly coupling the inflation member with an inflation mechanism provided at the proximal end of the navigator catheter, the inflation mechanism selectably pressurizing and depressurizing a fluid within the inflation lumen to respectively inflate and deflate the inflatable member to develop a desired bend angle.

31. The system of claim 18, wherein the guide catheter has an outer diameter of about 10 French or less, and the navigator member has an outer diameter of about 8 French or less.

32. The system of claim 18, wherein the guide catheter comprises a longitudinal pre-stress line extending between the distal and proximal ends of the guide catheter, the guide catheter splitting along the longitudinal pre-stress line upon guide catheter retraction in a proximal direction.

33. The system of claim 18, wherein the navigator member comprises a navigator catheter, the navigation catheter further comprising a lumen through which a contrast media can be communicated for mapping vasculature.

34. A guide catheter system, comprising:

a guide catheter comprising a flexible shaft and having a proximal end, a distal end, and a main lumen;

a navigator catheter having an outer wall including an aperture, a central lumen, a proximal end, and a distal end, the navigator catheter longitudinally displaceable within the main lumen of the guide catheter, the distal end of the navigator catheter dimensioned for passage into a cardiac vein distal to a patient'"'"'s coronary sinus ostium; and

a deflection member disposed within the central lumen of the navigator catheter proximate the aperture of the outer wall, the deflection member oriented at an angle relative to a longitudinal axis of the navigator catheter sufficient to deflect a guide wire passed within the central lumen through the aperture of the outer wall of the navigator catheter and into an angled vein branching from the cardiac vein.

35. The system of claim 34, wherein the angle of the deflection member is an acute angle relative to the longitudinal axis of the navigation catheter.

36. The system of claim 34, wherein the angle of the deflection member is an obtuse angle relative to the longitudinal axis of the navigation catheter.

37. The system of claim 34, wherein the deflection member is fixedly mounted within the central lumen.

38. The system of claim 34, wherein the deflection member is movably mounted to assume a plurality of angels relative to the longitudinal axis of the navigator catheter sufficient to deflect the guide wire through the aperture of the outer wall of the navigator catheter at a plurality of exit angles.

39. The system of claim 34, wherein the deflection member is pivotably mounted within the central lumen to assume a plurality of angels relative to the longitudinal axis of the navigator catheter sufficient to deflect the guide wire through the aperture of the outer wall of the navigator catheter at a plurality of exit angles.

40. The system of claim 39, wherein a central axis of the deflection member defines a pivot axis of the deflection member.

41. The system of claim 39, wherein the deflection member comprises a pivot axis, the pivot axis defined by a location at which one end of the deflection member is pivotally connected to an inner wall of the central lumen.

42. The system of claim 39, wherein the deflection member is connected to a deflection tendon, and application of forces to the deflection tendon causes the deflection member to pivot about a pivot axis.

43. The system of claim 42, wherein the deflection member comprises a bias mechanism, the bias mechanism generating a force opposing those applied to the deflection tendon.

44. The system of claim 34, wherein the guide catheter has an outer diameter of about 8 French or less.

45. The system of claim 34, wherein the guide catheter comprises a longitudinal pre-stress line extending between the distal and proximal ends of the guide catheter, the guide catheter splitting along the longitudinal pre-stress line upon guide catheter retraction in a proximal direction.

46. The system of claim 34, wherein the guide catheter further comprises a lumen through which a contrast media can be communicated for mapping vasculature.

47. A method of navigating coronary vasculature, comprising:

providing a guide catheter system comprising a guide catheter, a navigator catheter longitudinally displaceable within the guide catheter, and a deflection arrangement provided at a distal end of the navigator catheter;

advancing the guide catheter to at least a patient'"'"'s coronary sinus ostium;

extending the navigator catheter from the guide catheter to a location proximate or within an angled vein distal to the coronary sinus ostium;

using the deflection arrangement to direct a guide wire passing through the navigation catheter into the angled vein; and

advancing a lead having an open lumen over the guide wire to direct the lead to an implant site within the angled vein.

48. The method of claim 47, wherein using the deflection arrangement comprises using a pre-shaped distal bend at a distal end of the navigator catheter to direct the guide wire into the angled vein.

49. The method of claim 48, wherein the pre-shaped distal bend directs the guide wire into the angled vein at an acute angle relative to a longitudinal axis of the navigator catheter proximal of the pre-shaped distal bend.

50. The method of claim 48, wherein the pre-shaped distal bend directs the guide wire into the angled vein at a obtuse angle relative to a longitudinal axis of the navigator catheter proximal of the pre-shaped distal bend.

51. The method of claim 47, wherein using the deflection arrangement comprises using a shaping member to impart a pre-determined shape on a flexible distal end of the navigation catheter.

52. The method of claim 47, wherein using the deflection arrangement comprises changing a bend angle at a distal end region of the navigator catheter.

53. The method of claim 47, wherein using the deflection arrangement comprises changing a shape of a distal end region of the navigator catheter.

54. The method of claim 47, wherein using the deflection arrangement comprises controlling the deflection arrangement to direct the guide wire into the angled vein using a physician controlled deflection angle.

55. The method of claim 54, wherein controlling the deflection arrangement comprises controllably pressurizing and depressurizing the deflection arrangement to control the deflection angle.

56. The method of claim 54, wherein controlling the deflection arrangement comprises controllably changing an orientation of the deflection arrangement to control the deflection angle.

57. The method of claim 54, wherein controlling the deflection arrangement comprises controllably pivoting the deflection arrangement to control the deflection angle.

58. The method of claim 47, further comprising communicating a contrast dye through the navigator catheter to facilitate blood vessel mapping.

59. The method of claim 47, further comprising splitting the guide catheter at a proximal end while retracting the guide catheter from the patient.

60. A method of navigating coronary vasculature, comprising:

providing a guide catheter system comprising a guide catheter, a navigator catheter longitudinally displaceable within the guide catheter, and a deflection arrangement provided at a distal end of the navigator catheter;

advancing the guide catheter to at least a patient'"'"'s coronary sinus ostium;

extending the navigator catheter from the guide catheter to a location proximate an angled vein distal to the coronary sinus ostium;

seating the navigator catheter within the angled vein;

passing the guide catheter over the navigator catheter to advance the guide catheter into the angled vein;

retracting the navigator catheter from the guide catheter; and

advancing a lead through the guide catheter to an implant site within the angled vein.

61. The method of claim 60, further comprising using a guide wire passing through and beyond the navigator catheter to assist in locating one or both of the coronary sinus ostium and the angled vein.

62. The method of claim 60, wherein seating the navigator catheter comprises using a pre-shaped distal bend at a distal end of the navigator catheter to access the angled vein.

63. The method of claim 62, wherein the pre-shaped distal bend defines an acute angle relative to a longitudinal axis of the navigator catheter proximal of the pre-shaped distal bend.

64. The method of claim 62, wherein the pre-shaped distal bend defines an obtuse angle relative to a longitudinal axis of the navigator catheter proximal of the pre-shaped distal bend.

65. The method of claim 60, wherein seating the navigator catheter comprises using a shaping member to impart a pre-determined shape on a flexible distal end of the navigation catheter, and using the shaped flexible distal end of the navigator catheter to access the angled vein.

66. The method of claim 60, wherein seating the navigator catheter comprises changing a bend angle at a distal end region of the navigator catheter.

67. The method of claim 60, wherein seating the navigator catheter comprises changing a shape of a distal end region of the navigator catheter.

68. The method of claim 60, wherein seating the navigator catheter comprises controlling a deflection arrangement proximate a distal end of the navigator catheter to access the angled vein.

69. The method of claim 68, wherein controlling the deflection arrangement comprises controllably pressurizing and depressurizing the deflection arrangement to control a deflection angle of a distal portion of the navigator catheter.

70. The method of claim 60, further comprising communicating a contrast dye through the navigator catheter to facilitate blood vessel mapping.

71. The method of claim 60, further comprising splitting the guide catheter at a proximal end while retracting the guide catheter from the patient.