Ultrasound imaging catheter with a cutting element

• US 5,967,984 A
• Filed: 11/27/1996
• Issued: 10/19/1999
• Est. Priority Date: 06/30/1995
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Corporation
• Original Assignee: Boston Scientific Corporation
• Inventors: Brusard, George G., Fishbein, Christopher G., Young, David K., Stahley, William H., Chin, Yem, Chu, Michael S. H., Bagley, Demetrius H.
• Primary Examiner(s): Jaworski, Francis J.
• Application Number:
  US08/757,848
• Time in Patent Office: 1,056 Days
• Field of Search: 600/437, 600/439, 600/463-464, 600/470-471, 606/41-45, 607/101, 607/122
• US Class Current: 600/439
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00924 for ultrasonic waves
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00422 Angioplasty
• CPC Class Codes: A61B 2018/144 Wire
• CPC Class Codes: A61B 2018/1475 Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2090/3782 transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/445 Details of catheter construction
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

The invention features a catheter having a catheter body of extended length for insertion within a body of a living being. The catheter also includes an ultrasound imaging device disposed within a distal portion of the catheter body. The ultrasound imaging device generates electrical signals used by an ultrasound imaging system to display a real-time image of tissue surrounding the distal portion of the catheter. The catheter further includes a cutting element, e.g., an electrode wire or a laser fiber, having a proximal portion disposed within the catheter body. The catheter also includes a mechanism connected to the catheter body that causes the distal portion of the cutting element to extend from the catheter body. The distal portion of the cutting element generates energy in tissue with which it is brought in proximity to form a cut in the tissue. The ultrasound imaging device is positioned relative to the cutting element such that the real-time image produced by the ultrasound imaging system can include the cutting element in relation to the tissue.

Claims

1. A catheter adapted to treat a vessel stricture, comprising:

a catheter body of extended length constructed to be inserted within a body of a living being;

an ultrasound imaging device disposed within a distal portion of said catheter body, said ultrasound imaging device being constructed to generate acoustic energy, to receive reflections of said acoustic energy, and to generate electrical signals in response thereto for use by an ultrasound imaging system constructed to display a real-time image, produced by said ultrasound imaging device, of tissue surrounding said distal portion of said catheter; and

a cutting element comprising an electrode wire carried by said catheter body and being constructed to form a cut in said tissue,

said ultrasound imaging device and said electrode wire adapted so that said real-time image includes said electrode wire in relation to said tissue.

2. The catheter of claim 1, further comprising a mechanism, connected to said catheter body and constructed to cause said cutting element to extend from said catheter body.

3. The catheter of claim 2, wherein said mechanism is a dilatation balloon.

4. The catheter of claim 3, wherein said mechanism further includes a syringe for inflating said dilatation balloon.

5. The catheter of claim 3, wherein said dilatation balloon is a mesh dilatation balloon.

6. The catheter of claim 5, wherein catheter body includes an inner catheter body and an outer catheter body and wherein said mechanism further includes a handle for moving said outer catheter body relative to said inner catheter body.

7. The catheter of claim 2, wherein said mechanism is constructed to advance said catheter body relative to a proximal portion of said cutting element and to cause a distal portion of said catheter body to bend.

8. The catheter of claim 2, wherein said mechanism is an axial translation device coupled to a proximal portion of said cutting element.

9. The catheter of claim 8, wherein said mechanism further includes:

a hypo tube disposed in a lumen in said catheter body, wherein said hypo tube directs said cutting element outside said catheter body.

10. The catheter of claim 9, wherein said hypo tube further directs said cutting element outwardly away from said catheter body.

11. The catheter of claim 8, wherein said mechanism further includes:

a ramp disposed in a lumen in said catheter body, wherein said ramp directs said cutting element outside said catheter body.

12. The catheter of claim 11, wherein said ramp further directs said cutting element outwardly away from said catheter body.

13. The catheter of claim 1, wherein said cutting element includes a distal portion and said distal portion of said cutting element is pre-curved.

14. The catheter of claim 1, wherein said cutting element includes a distal portion and said catheter body includes:

a slot along which said distal portion of said cutting element is translated, wherein said cut is a linear cut.

15. The catheter of claim 1, wherein the catheter is adapted to remove a vessel stricture having a calcified region.

16. The catheter of claim 1, wherein said ultrasound imaging device is an ultrasound imaging transducer.

17. The catheter of claim 1, further comprising a motor coupler for coupling a drive shaft of said ultrasound imaging device to a motor, said motor being capable of rotating said drive shaft 360°

, wherein rotation of said drive shaft rotates a transducer of said ultrasound imaging device such that said image is a 360°

cross-section of a portion of said body of said living being surrounding said transducer.

18. The catheter of claim 1, wherein said cutting element includes a distal portion and said catheter body includes

a stiff proximal portion having good torque transfer characteristics,

a distal portion, and

a sonolucent mid portion connected between said proximal portion and said distal portion and located adjacent to said distal portion of said cutting element.

19. The catheter of claim 18, wherein said stiff proximal portion includes a layer of braided polymer between two layers of polyethylene.

20. The catheter of claim 18, wherein said mid portion includes a layer of polyethylene.

21. The catheter of claim 1, wherein said catheter comprises a shaft having an axis and said cutting element is oriented longitudinal to the axis of the catheter shaft.

22. The catheter of claim 1, wherein said cutting element is adapted to provide a cut which is radially outward from said catheter body.

55. The catheter of claim 1, further including a dilatation balloon that is adapted to be expanded to cause vessel fluids in the area of the balloon to be displaced so as to create an essentially dry zone in the vessel, the electrode wire including an exposed conductive portion adapted to be located in the dry zone.

56. The catheter of claim 55, wherein the dilatation balloon includes a diameter sized to be at least as large as the diameter of the vessel when expanded.

57. The catheter of claim 55, wherein said electrode is adapted to cut tissue at a low power in the dry zone.

58. The catheter of claim 57, wherein said electrode is adapted to cut tissue in the dry zone at a power of about 50 watts.

59. The catheter of claim 55, wherein the electrode wire terminates in a distal tip including the exposed conductive portion.

60. The catheter of claim 59, wherein the catheter carries a guide wire, the electrode adapted to be carried by the guide wire.

61. The catheter of claim 59, wherein the electrode wire includes stabilizer wings near the distal tip.

62. The catheter of claim 55, wherein the balloon includes a sleeve made of a sonolucent insulative material that the electrode wire extends through.

63. The catheter of claim 62, wherein the sleeve is made of silicone.

64. The catheter of claim 1, further including a half balloon located on one side of the distal portion of the catheter body and the electrode wire located on an opposite side of the distal portion of the catheter body.

23. A catheter adapted to treat a vessel stricture, comprising:

a catheter body of extended length constructed to be inserted within a body of a living being;

an ultrasound imaging device disposed within a distal portion of said catheter body, said ultrasound imaging device being constructed to generate acoustic energy, to receive reflections of said acoustic energy, and to generate electrical signals in response thereto for use by an ultrasound imaging system constructed to display a real-time image, produced by said ultrasound imaging device, of tissue surrounding said distal portion of said catheter;

a cutting element comprising an electrode wire carried by said catheter body and being constructed to form a cut in said tissue;

a mechanism connected to said catheter body and constructed to cause said cutting element to extend outwardly away from said catheter body; and

said ultrasound imaging device and said electrode wire adapted so that said real-time image includes said electrode wire in relation to said tissue.

24. The catheter of claim 23, wherein said electrode wire is constructed to generate electric current in tissue in proximity to said electrode wire, said electric current being sufficient to form said cut.

25. The catheter of claim 23, wherein said mechanism is a dilatation balloon.

26. The catheter of claim 25, wherein said mechanism further includes a syringe for inflating said dilatation balloon.

27. The catheter of claim 26, wherein said dilatation balloon is a mesh dilatation balloon.

28. The catheter of claim 27, wherein said catheter body includes an inner catheter body and an outer catheter body and wherein said mechanism further includes a handle for moving said,outer catheter body relative to said inner catheter body.

29. The catheter of claim 23, wherein said mechanism is constructed to advance said catheter body relative to a proximal portion of said cutting element and to cause a distal portion of said catheter body to bend.

30. The catheter of claim 23, wherein said mechanism is an axial translation device coupled to a proximal portion of said cutting element.

31. The catheter of claim 30, wherein said mechanism further includes:

a hypo tube disposed in a lumen in said catheter body, wherein said hypo tube directs said cutting element outside said catheter body.

32. The catheter of claim 30, wherein said mechanism further includes:

a ramp disposed in a lumen in said catheter body, wherein said ramp directs said cutting element outside said catheter body.

33. The catheter of claim 23, wherein said mechanism is adapted to allow a linear cut to be formed in the tissue with said cutting element.

34. The catheter of claim 23, wherein said mechanism is is adapted to allow a circular cut to be formed in the tissue with said cutting element.

35. The catheter of claim 23, wherein said mechanism is is adapted to allow a depth of a cut in the tissue to be increased with said cutting element.

36. A catheter adapted to treat a vessel stricture, comprising:

a catheter body of extended length constructed to be inserted within a body of a living being;

an ultrasound imaging device disposed within a distal portion of said catheter body, the distal portion including a sonolucent portion circumferentially surrounding the ultrasound imaging device, said ultrasound imaging device being constructed to generate acoustic energy for transfer through the sonolucent portion, to receive reflections of said acoustic energy through the sonolucent portion, and to generate electrical signals in response thereto for use by an ultrasound imaging system constructed to display a real-time image, produced by said ultrasound imaging device, of tissue surrounding said distal portion of said catheter;

a cutting element comprising an electrode wire carried by said catheter body and being constructed to form a cut in said tissue;

a mechanism connected to said catheter body and constructed to bring said cutting element into proximity with said tissue to form said cut in said tissue without adjustment of the position of said catheter body within said body of said living being or the position of said ultrasound imaging device within said catheter body; and

said ultrasound imaging device and said electrode wire adapted so that said real-time image includes said electrode wire in relation to said tissue.

37. The catheter of claim 36, wherein said mechanism is a dilatation balloon.

38. The catheter of claim 37, wherein said mechanism further includes a syringe for inflating said dilatation balloon.

39. The catheter of claim 38, wherein said dilatation balloon is a mesh dilatation balloon.

40. The catheter of claim 39, wherein catheter body includes an inner catheter body and an outer catheter body and wherein said mechanism further includes a handle for moving said outer catheter body relative to said inner catheter body.

41. The catheter of claim 36, wherein said mechanism is constructed to advance said catheter body relative to a proximal portion of said cutting element and to cause a distal portion of said catheter body to bend.

42. The catheter of claim 36, wherein said mechanism is an axial translation device coupled to a proximal portion of said cutting element.

43. The catheter of claim 42, wherein said mechanism further includes:

a hypo tube disposed in a lumen in said catheter body, wherein said hypo tube directs said cutting element outside said catheter body.

44. The catheter of claim 42, wherein said mechanism further includes:

a ramp disposed in a lumen in said catheter body, wherein said ramp directs said cutting element outside said catheter body.

45. The catheter of claim 36, wherein said mechanism is is adapted to allow a linear cut to be formed in the tissue with said cutting element.

46. The catheter of claim 36, wherein said mechanism is is adapted to allow a circular cut to be formed in the tissue with said cutting element.

47. The catheter of claim 36, wherein said mechanism is adapted to allow a depth of a cut in the tissue to be increased with said cutting element.

48. A catheter adapted to treat a vessel stricture, comprising:

catheter body of extended length constructed to be inserted within a body of a living being,

an ultrasound imaging device disposed within a distal portion of said catheter body, said ultrasound imaging device being constructed to generate acoustic energy, to receive reflections of said acoustic energy, and to generate electrical signals in response thereto for use by an ultrasound imaging system constructed to display a real-time image, produced by said ultrasound imaging device, of tissue surrounding said distal portion of said catheter,

a cutting element carried by said catheter body and being constructed to form a cut in said tissue, and

an axial translation device mechanically coupled with said ultrasound imaging device to permit longitudinal movement of said ultrasound imaging device with respect to said catheter body, and thereby to permit relative movement between said ultrasound imaging device and said distal portion of said cutting element so that said imaging device images said cutting element as well as said stricture.

49. The catheter of claim 48, wherein said cutting element is an electrode wire.

50. The catheter of claim 48, wherein said cutting element is a laser fiber.

51. The catheter of claim 48, further comprising a computer arranged to store images produced by said ultrasound imaging device as said ultrasound imaging device is moved along the length of the catheter body, said computer being capable of compiling the stored images into a three-dimensional image of said tissue surrounding the catheter body along the axial length of transducer travel.

52. The catheter of claim 48, further comprising a computer arranged to store images produced by said ultrasound imaging device as said ultrasound imaging device is moved along the length of the catheter body, said computer being capable of compiling the stored images into a series of two-dimensional images of said tissue surrounding the catheter body along the axial length of transducer travel.

53. The catheter of claim 48, wherein said image is a sonographic image.

54. The catheter of claim 48, wherein said image is a monographic image.