Steerable catheter

• US 5,876,373 A
• Filed: 04/04/1997
• Issued: 03/02/1999
• Est. Priority Date: 04/04/1997
• Status: Expired due to Term

• Current Assignee: Cryolife Incorporated
• Original Assignee: Eclipse Surgical Technologies, Inc. (Cryolife Incorporated)
• Inventors: Wilson, James Edward, Horzewski, Michael, Giba, Jeffrey
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/833,352
• Time in Patent Office: 697 Days
• Field of Search: 604/95, 604/264, 604/280, 604/281, 600/139, 600/146, 600/147-151
• US Class Current: 604/95.04
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00336 with a protective sleeve, e.g. retractable or slidable
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00738 Depth, e.g. depth of ablation
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0141 having flexible regions as a result of using materials with different mechanical properties
• CPC Class Codes: A61M 25/0144 having flexible regions as a result of inner reinforcement means, e.g. struts or rods
• 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: A61M 25/0158 with magnetic or electrical means, e.g. by using piezo materials, electroactive polymers, magnetic materials or by heating of shape memory materials

Abstract

An elongated steerable catheter for placement within a heart chamber, organ aperture or other body opening and having at least one center tube with hollow passageway for guiding a laser delivery means or other functional device to selected surfaces of a heart chamber, organ aperture or other body cavity for laser or other treatment thereon, particularly adapted for laser-assisted percutaneous transmyocardial revascularization (TMR), is disclosed herein. The steerable catheter has a handle portion at its proximal end and a controllably deflectable end portion at its distal end. The elongated center tube has a distal end, in the region where a curvature is to be formed, and a shim anchor sleeve is slidably disposed over the center tube. The shim anchor sleeve is attached to the inside wall of the outer jacket and coupled to the distal end of the center tube with a bendable shim member which extends between the distal tip of the steerable catheter and the sleeve over the center tube. Opposite the shim is a guide for a pull cable, the pull cable attached to the distal end of the steerable catheter and extending through the guide to the handle. Thus, the shim is maintained radially opposite the pull cable with the center tube in between. An outer jacket has, in a preferred embodiment, distinct sections of different stiffness or durometer. A distal, more flexible portion is coupled to a proximal, stiffer portion. The shim anchor sleeve is positioned at or near the junction of two portions of the outer jacket. Thus, the center tube moves freely through the shim anchor sleeve. Adjacent the handle, the outer jacket terminates at the catheter base. The pull cable extends past the catheter base, through a deflection housing tube, and terminates in a cable stop. Rotation of a deflection knob threadably mounted onto the deflection housing tube will cause the pull cable to be pulled backward, or the outer jacket to be pushed forward, relative to each other, thereby inducing deflection of the distal end of the steerable catheter.

Claims

1. A steerable catheter insertable through the vasculature comprising:

a hollow outer jacket having proximal and distal ends and a distal tip at the distal end;

at least one inner tube within the hollow outer jacket, the inner tube having a distal end attached to the distal tip, the inner tube further having a proximal region free to move within the hollow outer jacket, the inner tube adapted for insertion therethrough of at least one tool disposed therein; and

a deflection mechanism comprising an actuating assembly at the proximal end of the hollow outer jacket, the actuating assembly operatively attached to a deflector device at the distal end of the hollow outer jacket, the free to move inner tube sliding within the outer jacket during activation of the deflector device by the actuating assembly to deflect the distal end of the hollow outer jacket.

2. The steerable catheter of claim 1 in which the actuating assembly is disposed within a handle attached to the proximal end of the hollow outer jacket, the handle defining a coupling means.

3. The steerable catheter of claim 2 in which the handle further comprises an advance mechanism attached to the coupling means for advancing a functional device through the inner tube.

4. The steerable catheter of claim 3 in which the advance mechanism further comprises a depth stop adjustment means for controlling an advance distance of the functional device.

5. The steerable catheter of claim 3 further comprising the functional device which is a laser delivery means, the advance mechanism for advancing the laser delivery means.

6. The steerable catheter of claim 3 further comprising the functional device which is a drug delivery apparatus, the advance mechanism for delivering a drug through the steerable catheter.

7. The steerable catheter of claim 3 further comprising the functional device which is a mechanical piercing tool, the advance mechanism for advancing the piercing tool through the steerable catheter.

8. The steerable catheter of claim 2 wherein the outer jacket defines an inside wall and the steerable catheter further comprises a shim anchor sleeve attached to the inside wall of the outer jacket, the shim anchor sleeve defining at least one lumen therethrough, the inner tube slidable within the at least one lumen.

9. The steerable catheter of claim 8 wherein the deflector device further comprises a shim mounted to the distal tip and to the shim anchor sleeve, the deflector device further having a cable mounted to the distal tip and extending through the shim anchor sleeve and into the actuating assembly.

10. The steerable catheter of claim 9 wherein the shim anchor sleeve is disposed a selected distance from the distal tip thereby defining and distinguishing a deflectable end portion from an elongated central torquing portion of the steerable catheter, the shim extending through the deflectable end portion.

11. The steerable catheter of claim 2 wherein the actuating assembly comprises:

a catheter base having proximal and distal ends, the distal end of the catheter base coupled to the proximal end of the outer jacket;

a deflection housing tube having proximal and distal ends, the distal end operatively coupled to the proximal end of the catheter base;

an adjustable cable stop within the deflection housing tube; and

at least one cable fixedly attached to the adjustable cable stop, whereby selective, axial translation of the deflection housing tube occurs relative to the catheter base during deflection.

12. The steerable catheter of claim 11 further comprising:

a deflection knob rotatably mounted to the catheter base and defining at least one helical groove;

the deflection housing tube defining at least one mating helical groove whereby rotation of the deflector knob causes axial translation of the deflection housing tube.

13. The steerable catheter of claim 1 further comprising a retractable piercing tip attached to the distal tip.

14. The steerable catheter of claim 13, in which the piercing tip defines an activation mechanism for causing the piercing tip to be extended distally from the distal tip when desired.

15. The steerable catheter of claim 1, further comprising a helical coil spring disposed between at least a portion of the outer jacket and the inner tube.

16. The steerable catheter of claim 15, in which the helical coil spring is made at least in part of a radiopaque material to enhance visualization.

17. The steerable catheter of claim 1 further comprising a coil spring wrapped around at least a portion of the inner tube for providing structural support and for enhancing controllable deflection of the distal end of the hollow outer jacket.

18. The steerable catheter of claim 1 in which at least portions of at least the inner tube comprise shape memory materials of construction.

19. The steerable catheter of claim 1 in which at least portions of at least the outer jacket comprise shape memory materials of construction.

20. The steerable catheter of claim 1, in which the distal tip is made at least in part of a radiopaque material to enhance visualization.

21. The steerable catheter of claim 1 in which the outer jacket has at least two portions, a distal, more flexible, deflectable end portion and a proximal, less flexible, steerable and torquable portion.

22. A deflectable, steerable catheter comprising:

a handle assembly having a deflection actuator;

an outer jacket having a deflectable distal end and a proximal end, the proximal end attached to the handle assembly, the deflectable distal end defining a distal tip;

an inner tube positioned within the outer jacket and having a proximal end and a distal end, the distal end of the inner tube attached to the distal tip, the proximal end of the inner tube extending into and slidable within the handle assembly and the outer jacket; and

a deflection mechanism extending between the distal tip and the handle assembly and operatively connected to the deflection actuator.

23. The steerable catheter of claim 22 in which the handle assembly further comprises an advance mechanism for advancing a functional device through the inner tube.

24. The steerable catheter of claim 23 in which the advance mechanism further comprises a depth stop adjustment means for controlling an advance distance of the functional device.

25. The steerable catheter of claim 23 further comprising the functional device which is a laser delivery means, the advance mechanism for advancing the laser delivery means.

26. The steerable catheter of claim 23 further comprising the functional device which is a drug delivery apparatus, the advance mechanism for delivering a drug through the steerable catheter.

27. The steerable catheter of claim 23 further comprising the functional device which is a mechanical piercing tool, the advance mechanism for advancing the piercing tool through the steerable catheter.

28. The steerable catheter of claim 22 wherein the outer jacket defines an inside wall and the steerable catheter further comprises a shim anchor sleeve attached to the inside wall of the outer jacket, the shim anchor sleeve defining at least one lumen therethrough, the inner tube slidable within the at least one lumen.

29. The steerable catheter of claim 28 wherein the deflection mechanism further comprises a shim mounted to the distal tip and to the shim anchor sleeve, the deflection mechanism further having a cable mounted to the distal tip and extending through the shim anchor sleeve and into the deflection actuator.

30. The steerable catheter of claim 29 wherein the shim anchor sleeve is disposed a selected distance from the distal tip thereby defining and distinguishing a deflectable end portion from an elongated central torquing portion of the steerable catheter, the shim extending through the deflectable end portion.

31. The steerable catheter of claim 22 wherein the deflection actuator comprises:

a catheter base having proximal and distal ends, the distal end of the catheter base coupled to the proximal end of the outer jacket;

a deflection housing tube having proximal and distal ends, the distal end operatively coupled to the proximal end of the catheter base;

an adjustable cable stop within the deflection housing tube; and

at least one cable fixedly attached to the adjustable cable stop, whereby selective, axial translation of the deflection housing tube occurs relative to the catheter base during deflection.

32. The steerable catheter of claim 31 further comprising:

a deflection knob rotatably mounted to the catheter base and defining at least one helical groove;

the deflection housing tube defining at least one mating helical groove whereby rotation of the deflector knob causes axial translation of the deflection housing tube.

33. The steerable catheter of claim 22 further comprising a helical coil spring disposed between at least a portion of the outer jacket and the inner tube.

34. The steerable catheter of claim 33, in which the helical coil spring is made at least in part of a radiopaque material to enhance visualization.

35. The steerable catheter of claim 22 further comprising a retractable piercing tip attached to the distal tip.

36. The steerable catheter of claim 35 in which the piercing tip defines an activation mechanism for causing the piercing tip to be extended distally from the distal tip when desired.

37. The steerable catheter of claim 22 further comprising a spring surrounding a portion of the inner tube.

38. The steerable catheter of claim 22 in which at least portions of at least the inner tube comprise shape memory materials of construction.

39. The steerable catheter of claim 22 in which at least portions of at least the outer jacket comprise shape memory materials of construction.

40. The steerable catheter of claim 22, in which the distal tip is made at least in part of a radiopaque material to enhance visualization.

41. The steerable catheter of claim 22 in which the outer jacket has at least two portions, a distal, more flexible, deflectable end portion and a proximal, less flexible, steerable and torquable portion.

42. A steerable catheter for insertion through the vasculature for performing percutaneous transmyocardial revascularization comprising a proximal end with a handle and a distal end with a deflection device therein coupled to a distal tip, the handle comprising an actuating assembly for activating the deflection device for causing deflection of the distal end, the steerable catheter further comprising an outer jacket extending between the handle and the distal tip and an inner tube within the outer jacket, the inner tube having a proximal end and a distal end, the proximal end of the inner tube extending into the handle and movable within the handle and the outer jacket, the distal end attached to the distal tip, the steerable catheter further comprising an optical fiber laser delivery means disposed within the inner tube for creating channels into myocardium from within a heart chamber.

43. The steerable catheter of claim 42 wherein the outer jacket defines an inside wall and the steerable catheter further comprises a shim anchor sleeve attached to the inside wall of the outer jacket, the shim anchor sleeve defining at least one lumen therethrough, the inner tube slidable within the at least one lumen.

44. The steerable catheter of claim 43 wherein the deflection device further comprises a shim mounted to the distal tip and to the shim anchor sleeve, the deflection device further having a cable mounted to the distal tip and extending through the shim anchor sleeve and into the actuating assembly.

45. The steerable catheter of claim 44 wherein the shim anchor sleeve is disposed a selected distance from the distal tip thereby defining and distinguishing a deflectable end portion from an elongated central torquing portion of the steerable catheter, the shim extending through the deflectable end portion.

46. The steerable catheter of claim 42 further comprising a retractable piercing tip attached to the distal tip.

47. The steerable catheter of claim 46 in which the piercing tip defines an activation mechanism for causing the piercing tip to be extended distally from the distal tip when desired.

48. The steerable catheter of claim 42 further comprising a spring surrounding a portion of the inner tube.

49. The steerable catheter of claim 48, in which the spring is made at least in part of a radiopaque material to enhance visualization.

50. The steerable catheter of claim 42 further comprising an advance mechanism coupled to the handle for advancing the optical fiber laser delivery means through the inner tube.

51. The steerable catheter of claim 50 in which the advance mechanism further comprises a depth stop adjustment means for controlling an advance distance of the optical fiber laser delivery means.

52. The steerable catheter of claim 42 wherein the actuating assembly comprises:

a catheter base having proximal and distal ends, the distal end of the catheter base coupled to the proximal end of the outer jacket;

a deflection housing tube having proximal and distal ends, the distal end operatively coupled to the proximal end of the catheter base;

an adjustable cable stop within the deflection housing tube; and

at least one cable fixedly attached to the adjustable cable stop, whereby selective, axial translation of the deflection housing tube occurs relative to the catheter base during deflection.

53. The steerable catheter of claim 52 further comprising:

a deflection knob rotatably mounted to the catheter base and defining at least one helical groove;

the deflection housing tube defining at least one mating helical groove whereby rotation of the deflector knob causes axial translation of the deflection housing tube.

54. The steerable catheter of claim 42 in which at least portions of at least the inner tube comprise shape memory materials of construction.

55. The steerable catheter of claim 42 in which at least portions of at least the outer jacket comprise shape memory materials of construction.

56. The steerable catheter of claim 42, further comprising a connector attached to the handle and having a first port for introducing the laser delivery means and a second port for introducing a drug.

57. The steerable catheter of claim 42, in which the distal tip is made at least in part of a radiopaque material to enhance visualization.

58. The steerable catheter of claim 42 in which the outer jacket has at least two portions, a distal, more flexible, deflectable end portion and a proximal, less flexible, steerable and torquable portion.

59. A steerable catheter for insertion through the vasculature for administering drugs to a heart of a patient comprising a proximal end with a handle and a distal end with a deflection device therein coupled to a distal tip, the handle comprising an actuating assembly for activating the deflection device for causing deflection of the distal end, the steerable catheter further comprising an outer jacket extending between the handle and the distal tip and an inner tube within the outer jacket, the inner tube having a proximal end and a distal end, the proximal end of the inner tube extending into the handle and movable within the handle and the outer jacket, the distal end attached to the distal tip, the steerable catheter further comprising a drug delivery module attached to the handle, the drug delivery module having at least one lumen communicating with the inner tube.

60. The steerable catheter of claim 59 wherein the outer jacket defines an inside wall and the steerable catheter further comprises a shim anchor sleeve attached to the inside wall of the outer jacket, the shim anchor sleeve defining at least one lumen therethrough, the inner tube slidable within the at least one lumen.

61. The steerable catheter of claim 60 wherein the deflection device further comprises a shim mounted to the distal tip and to the shim anchor sleeve, the deflection device further having a cable mounted to the distal tip and extending through the shim anchor sleeve and into the deflection module.

62. The steerable catheter of claim 60 wherein the shim anchor sleeve is disposed a selected distance from the distal tip thereby defining and distinguishing a deflectable end portion from an elongated central torquing portion of the steerable catheter, the shim extending through the actuating assembly.

63. The steerable catheter of claim 59 further comprising a retractable piercing tip attached to the distal tip.

64. The steerable catheter of claim 63 in which the piercing tip defines an activation mechanism for causing the piercing tip to be extended distally from the distal tip when desired.

65. The steerable catheter of claim 59 wherein the actuating assembly comprises:

a catheter base having proximal and distal ends, the distal end of the catheter base coupled to the proximal end of the outer jacket;

a deflection housing tube having proximal and distal ends, the distal end operatively coupled to the proximal end of the catheter base;

an adjustable cable stop within the deflection housing tube; and

at least one cable fixedly attached to the adjustable cable stop, whereby selective, axial translation of the deflection housing tube occurs relative to the catheter base during deflection.

66. The steerable catheter of claim 65 further comprising:

a deflection knob rotatably mounted to the catheter base and defining at least one helical groove;

the deflection housing tube defining at least one mating helical groove whereby rotation of the deflector knob causes axial translation of the deflection housing tube.

67. The steerable catheter of claim 59, further comprising a helical coil spring disposed between at least a portion of the outer jacket and the inner tube.

68. The steerable catheter of claim 67, in which the helical coil spring is made at least in part of a radiopaque material to enhance visualization.

69. The steerable catheter of claim 59 further comprising a spring surrounding a portion of the inner tube.

70. The steerable catheter of claim 59 in which at least portions of at least the inner tube comprise shape memory materials of construction.

71. The steerable catheter of claim 59 in which the handle further comprises an advance mechanism for advancing the drugs through the inner tube.

72. The steerable catheter of claim 59 in which at least portions of at least the outer jacket comprise shape memory materials of construction.

73. The steerable catheter of claim 59, in which the distal tip is made at least in part of a radiopaque material to enhance visualization.

74. The steerable catheter of claim 59 in which the outer jacket has at least two portions, a distal, more flexible, deflectable end portion and a proximal, less flexible, steerable and torquable portion.