Acoustic ablation

• US 5,630,837 A
• Filed: 03/31/1995
• Issued: 05/20/1997
• Est. Priority Date: 07/01/1993
• Status: Expired due to Term

• Current Assignee: Specialized Health Products, Inc. (Becton, Dickinson & Co), Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Corporation
• Inventors: Crowley, Robert J.
• Primary Examiner(s): JAWORSKI, FRANCIS J
• Application Number:
  US08/415,514
• Time in Patent Office: 781 Days
• Field of Search: 128/660.03, 128/662.06, 604/22, 601/2, 606/49, 607/97, 607/115, 607/122
• US Class Current: 601/2
• CPC Class Codes: A61B 17/2202 the ultrasound transducer being inside patient's body at the distal end of the catheter
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• 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 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00924 for ultrasonic waves
• CPC Class Codes: A61B 2017/22021 electric leads passing through the catheter
• CPC Class Codes: A61B 2017/22024 with a part reflecting mechanical vibrations, e.g. for focusing
• CPC Class Codes: A61B 2017/22028 arrays, e.g. phased arrays
• 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 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00077 high, i.e. electrically conducting
• CPC Class Codes: A61B 2018/00107 Coatings on the energy applicator
• CPC Class Codes: A61B 2018/00148 with metal
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00273 : Anchoring means for temporary attachment of a device to tissue
• CPC Class Codes: A61B 2018/00351 : Heart
• CPC Class Codes: A61B 2018/00577 : Ablation
• CPC Class Codes: A61B 2018/00797 : measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00869 : Phase
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2018/1435 : Spiral
• CPC Class Codes: A61B 2034/2063 : Acoustic tracking systems, e.g. using ultrasound
• CPC Class Codes: A61B 2090/065 : for measuring contact or contact pressure
• 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 2090/3925 : ultrasonic
• 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: A61B 8/4488 : the transducer being a phased array
• CPC Class Codes: A61B 90/39 : Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61N 7/02 : Localised ultrasound hyperthermia hyperthermia in general A61F7/00
• CPC Class Codes: B06B 1/0633 : Cylindrical array

Abstract

The invention features a catheter system and a method for tissue ablation. A catheter body of extended length is constructed for delivery to locations within a body of a living being and for connection to a power source. An array of acoustic transducers are constructed for receiving power from the power source and for generating acoustic energy, in response to power received from the power source. The acoustic energy generated by the acoustic transducers is sufficient for ablation of tissue. A mechanism independently controls one or more of the ablation transducers to produce a desired acoustic energy pattern for ablating tissue at a select location spaced from the catheter system. The acoustic transducers have an annular configuration designed for generating acoustic energy that radiates in a radial pattern surrounding the circumference of the catheter body.

Claims

1. A catheter system for tissue ablation, comprising:

a catheter body of extended length constructed for delivery to locations within a body of a living being, said catheter body being adapted for connection to a power source,

an array of acoustic transducers disposed along the length of said catheter body and constructed for receiving power from said power source and for generating acoustic energy, in response to said received power, sufficient for ablation of tissue, and

a mechanism for controlling one or more of said ablation transducers independently of other ones of said transducers to produce a desired acoustic energy pattern for ablating tissue at a select location spaced from said catheter,

at least one of said acoustic transducers having an annular configuration designed for generating acoustic energy that radiates in a radial pattern surrounding the circumference of said catheter body.

2. The catheter system of claim 1, wherein each of said acoustic transducers is a full cylinder having said annular configuration.

3. The catheter system of claim 1, wherein each of said acoustic transducers is a half cylinder and wherein said transducers are arranged in pairs having said annular configuration.

4. The catheter system of claim 1, wherein said annular configuration comprises a full cylinder.

5. The catheter system of claim 1, wherein said controlling mechanism controls said transducers individually.

6. The catheter system of claim 1, wherein the array is a plurality of annular acoustic transducers.

7. The catheter system of claim 1, wherein the mechanism includes a controller.

8. The catheter system of claim 1, wherein the mechanism includes a series of switches, including a switch coupling one or more of said ablation transducers to the power source.

9. The catheter system of claim 1, wherein the mechanism includes a phase controller for selectively varying the phase of said power driving said transducers.

10. The catheter system of claim 9, wherein the mechanism further includes

delay lines connecting the ablation transducers to said power source.

11. The catheter system of claim 1 wherein said mechanism includes a frequency control for varying the frequency of the power driving said transducers.

12. The catheter system of claim 1, further comprising:

insulation, positioned between adjacent transducers of the array of acoustic ablation transducers, to electrically and acoustically insulate adjacent transducers from each other.

13. The catheter system of claim 1 wherein said ablation transducers are embedded in the wall of said catheter body.

14. The catheter system of claim 1 including a lumenal space in heat transfer communication with said transducer array for providing a passage for a flow of cooling fluid to cool said transducers.

15. The catheter system of claim 1, wherein adjacent ablation transducers are spaced by a distance of about 0.001 to 0.12 inches.

16. The catheter system of claim 1, wherein said transducers have a beam angle from about 22°

to about 122°

.

17. The catheter system of claim 1, wherein said transducers are constructed for generating acoustic energy at power levels in the range of about 1 to 102 db.

18. The catheter system of claim 1, further comprising:

an array of matching layers corresponding to and coupled to the array of annular acoustic transducers.

19. The catheter system of claim 1 further comprising:

an acoustic energy redirection device positioned in the vicinity of said acoustic ablation transducer array and configured for directing acoustic energy produced by said acoustic ablation transducer array toward tissue to be ablated.

20. The catheter system of claim 19, wherein said redirection device is a reflecting shield positioned about a portion of said array.

21. The catheter system of claim 20, further comprising:

a rotation mechanism coupled to the catheter body for rotating the catheter body about its axis.

22. The catheter system of claim 1, further comprising:

a sheath for surrounding the catheter body, a portion of the sheath being sonolucent.

23. The catheter system of claim 22, wherein the catheter body includes a catheter lumenal space in heat communication with said transducers and a fluid port in communication with said catheter lumenal space, said catheter body is disposed within said sheath and said sheath further includes a sheath lumenal space for circulating cooling fluid through the sheath lumenal space, the fluid port, and the catheter lumenal space to cool said transducers.

24. The catheter system of claim 22, wherein said catheter body is disposed within said sheath and said sheath further includes a lumenal space in heat communication with said transducers and an outlet port in communication with said lumenal space for circulating cooling fluid through the sheath and the outlet port to cool the ablation transducers.

25. The catheter system of claims 22, wherein said catheter body is disposed within said sheath and said sheath includes an end opening through which said catheter body can be extended.

26. The catheter system of claim 22, wherein the sheath further includes a sonolucent standoff balloon.

27. The catheter system of claim 1, further including an acoustic imaging transducer.

28. The catheter system of claim 1 further including a radio frequency ablation electrode.

29. The catheter system of claim 1 further including mapping electrodes.

62. A method for tissue ablation comprising:

providing a catheter system for acoustic ablation as described in claim 1,

positioning said catheter system with an imaging device within a heart of said body of said living being such that the transducer array is located in proximity to cardiac tissue to be ablated,

controlling one or more of said ablation transducers to provide a therapeutic energy pattern for ablation of tissue at a select location, and

withdrawing the catheter system from the body of the living being.

30. A catheter system for tissue ablation, comprising:

a catheter body of extended length constructed for delivery to locations within a body of a living being, said catheter body being adapted for connection to a power source,

an acoustic ablation device constructed for receiving power from said power source and for generating acoustic energy, in response to said received power, sufficient for ablation of tissue,

a flexible sheath of extended length constructed for delivery to locations within a body of a living being and constructed to receive said catheter body, said sheath being at least partially sonolucent,

a lumen within said catheter body, and

a fluid port in communication with said lumen and said sheath,

said fluid port being constructed to cause fluid to pass between said lumen and a space external to said catheter body and within said sheath,

said lumen and said sheath being constructed to cause fluid to pass in a longitudinal direction relative to said catheter body and in the vicinity of said acoustic ablation device to cool said acoustic ablation device.

31. The catheter system of claim 30, wherein said acoustic ablation device includes

a radiating outer surface, and

an inner surface.

32. The catheter system of claim 31, wherein said lumen causes fluid to pass in the vicinity of said inner surface.

33. The catheter system of claim 31, where said acoustic ablation device includes

an array of annular acoustic transducers.

34. A catheter system for tissue ablation, comprising:

a catheter body of extended length constructed for delivery to locations within a body of a living being, said catheter body being adapted for connection to a power source,

an acoustic ablation device constructed for receiving power from said power source and for generating acoustic energy, in response to said received power, sufficient for ablation of tissue, and

a sonolucent standoff balloon for positioning said acoustic ablation device in proximity to tissue to be ablated, said acoustic ablation device being positioned to ablate said tissue by passage of acoustic energy through said balloon.

35. A catheter system for tissue ablation, comprising:

a catheter body of extended length constructed for delivery to locations within a body of a living being, said catheter body being adapted for connection to a power source,

an acoustic ablation device constructed for receiving power from said power source and for generating acoustic energy, in response to said received power, sufficient for ablation of tissue, and

an acoustic energy redirection device positioned in the vicinity of said acoustic ablation device and constructed for redirecting a portion of acoustic energy produced by said acoustic ablation device in a direction of another portion of said acoustic energy produced by said acoustic ablation device toward tissue to be ablated.

36. The catheter system of claim 35, further comprising:

a rotation mechanism coupled to the catheter body for rotating the catheter body about its axis.

37. A catheter system for tissue ablation, comprising:

a catheter body of extended length constructed for delivery to locations within a body of a living being, said catheter body being adapted for connection to a power source,

a linear array of annular acoustic transducers disposed along the length of said catheter body and constructed for receiving power from said power source and for generating acoustic energy, in response to said received power, sufficient for ablation of tissue, and

a mechanism for selectively controlling one or more of said ablation transducers to produce a desired acoustic energy pattern for ablating tissue at a select location spaced from said catheter body, said mechanism including;

a power applicator configured for providing power to one or more of said transducers, and

a phase shifter configured for shifting the phase of said power provided to one or more of said transducers independently of other ones of said transducers.

38. The catheter system of claim 37, wherein said mechanism further includes a controller constructed to control said power applicator and said phase shifter.

39. The catheter system of claim 37, wherein said power applicator includes

a series of switches, including a switch coupling one or more of said ablation transducers to the power source.

40. The catheter system of claim 37, wherein said phase shifter includes

a phase controller for selectively varying the phase of said power provided to one or more of said transducers by said power applicator.

41. The catheter system of claim 40, wherein said phase shifter further includes

delay lines connecting one or more of said transducers to said power source.

42. The catheter system of claim 37, wherein said mechanism further includes

a frequency control device for varying the frequency of said power provided to one or more of said transducers by said power applicator.

43. A method for selective acoustic ablation of tissue within the body of a living being, comprising

providing a catheter system for acoustic ablation of tissue, said catheter system comprising:

a catheter body of extended length constructed for delivery to locations within a body of a living being, said catheter body being adapted for connection to a power source,

an array of acoustic transducers disposed along the length of said catheter body and constructed for receiving power from said power source and for generating acoustic energy, in response to said received power, sufficient for ablation of tissue, and

a mechanism for controlling one or more of said ablation transducers independently of other ones of said transducers to produce a desired acoustic energy pattern for ablating tissue at a select location spaced from said catheter body,

at least one of said acoustic transducers having an annular configuration designed for generating acoustic energy that radiates in a radial pattern surrounding the circumference of said catheter body, threading said catheter body into said body of said living being such that the transducer array is located in proximity to tissue to be ablated, and

controlling at least one of said ablation transducers to provide a desired energy pattern for ablation of tissue at a select location separated from said catheter body.

44. The method of claim 43, wherein controlling said transducers provides different shaped lesions.

45. The method of claim 44, wherein the different shaped lesions include a linear lesion.

46. The method of claim 43, wherein controlling said transducers ablates different discrete portions of tissue without moving said catheter body.

47. The method of claim 43, wherein controlling includes providing power selectively to the ablation transducers.

48. The method of claim 43, wherein controlling further includes controlling the phase of power applied to the ablation transducers.

49. The method of claim 43, wherein controlling includes controlling the frequency of power applied to the ablation transducers.

50. The method of claim 43 wherein controlling includes controlling said transducers in said array to ablate select discrete tissue locations radially adjacent select transducers in said array by providing power only to said select transducers and choosing a frequency to locate the maxima at the select discrete tissue locations.

51. The method of claim 43, wherein controlling includes controlling said transducers in said array to ablate a select discrete tissue area by controlling the phase of said transducers in a manner that acoustic energy from multiple transducers causes ablation in said area.

52. The method of claim 51, wherein said area has a width along the device axis that is shorter than said array.

53. The method of claim 51, wherein said area is axially beyond said transducer array.

54. The method of claim 43, wherein controlling includes controlling said transducers to ablate tissue in a ring-like pattern around said catheter body.

55. The method of claim 54, further comprising

delivering said catheter body into an atrium of a heart of said body of said living being for treating fibrillation.

56. The method of claim 43, wherein said catheter system includes mapping electrodes and said method further includes mapping a heart within said body of said living being to determine a location for said ablation.

57. The method of claim 43, further comprising:

flowing cooling fluid through a catheter lumenal space in heat communication with the transducer array to cool the transducer array.

58. The method of claim 43, further comprising, before the step of threading:

inserting the catheter body into a sheath have a sonolucent portion.

59. The method of claim 58, further comprising:

flowing cooling fluid through a sheath lumenal space in said sheath in heat communication with the transducers to cool the transducers.

60. The method of claim 59, wherein the step of flowing includes flowing cooling fluid through an outlet port in communication with said sheath lumenal space.

61. The method of claim 59, wherein the step of flowing includes flowing cooling fluid through a fluid port in communication with a catheter lumenal space and said sheath lumenal space.

63. A method for tissue ablation, comprising:

positioning a flexible sheath of extended length within a body of a living being, said sheath being at least partially sonolucent,

inserting a catheter system having a catheter body of extended length within said sheath, said catheter body being adapted for connection to a power source,

providing power from said power source to an acoustic ablation device constructed for receiving power,

generating acoustic energy with said acoustic ablation device, in response to said received power, said acoustic energy being sufficient for ablation of tissue, and

passing fluid through a lumen within said catheter body and through a fluid port in communication with said lumen and said sheath, said fluid port being constructed to cause the fluid to pass between said lumen and a space external to said catheter body and within said sheath, and said lumen and said sheath being constructed to cause the fluid to pass in a longitudinal direction relative to said catheter body and in the vicinity of said acoustic ablation device to cool said acoustic ablation device.

64. The method of claim 63, wherein generating acoustic energy includes

radiating acoustic energy from an outer surface of said acoustic ablation device.

65. The method of claim 64, wherein radiating acoustic energy includes radiation of acoustic energy in a radial pattern surrounding the circumference of said catheter body.

66. The method of claim 63, wherein passing fluid through said lumen causes fluid to pass in the vicinity of an inner surface of said acoustic ablation device.

67. A method for tissue ablation, comprising:

positioning a catheter body of extended length within a body of a living being, said catheter body being adapted for connection to a power source,

providing power to an acoustic ablation device constructed for receiving power from said power source,

generating acoustic energy with said acoustic ablation device, in response to said received power, said acoustic energy being sufficient for ablation of tissue,

placing a sonolucent standoff balloon within the body of the living being,

inserting said catheter body within said balloon such that said acoustic ablation device is positioned in proximity to tissue to be ablated, and

ablating said tissue by passage of acoustic energy through said balloon.

68. A method for tissue ablation, comprising:

positioning a catheter body of extended length within a body of a living being, said catheter body being adapted for connection to a power source,

providing power to an acoustic ablation device constructed for receiving power from said power source,

generating acoustic energy with said acoustic ablation device, in response to said received power, said acoustic energy being sufficient for ablation of tissue, and

redirecting a portion of said acoustic energy in a direction of another portion of said acoustic energy toward tissue to be ablated, with an acoustic energy redirection device positioned in the vicinity of said acoustic ablation device.

69. The method of claim 68, wherein redirecting said acoustic energy includes

reflecting said acoustic energy.

70. The method of claim 68, wherein redirecting includes

rotating said catheter body about its axis.

71. A method for tissue ablation, comprising:

positioning a catheter body of extended length within a body of a living being, said catheter body being adapted for connection to a power source,

providing power to a linear array of annular acoustic transducers disposed along the length of said catheter body and constructed for receiving power from said power source,

generating acoustic energy with said array of acoustic transducers, in response to said received power, said acoustic energy being sufficient for ablation of tissue, and

ablating tissue at a select location spaced from said catheter body by selectively controlling one or more of said ablation transducers independently of others of said ablation transducers to produce a desired acoustic energy pattern, including

providing said power to one or more of said transducers independently of other ones of said transducers, and

shifting the phase of said power provided to one or more of said transducers independently of other ones of said transducers.

72. The method of claim 71, wherein generating acoustic energy includes

radiating acoustic energy in a radial pattern surrounding the circumference of said catheter body.

73. The method of claim 71, wherein providing said power includes

switching said power on and off to one or more of said ablation transducers.

74. The method of claim 73, wherein varying the phase further includes

delaying the application of said power to one or more of said transducers.

75. The method of claim 71, wherein shifting the phase includes

varying the phase of said power provided to one or more of said transducers.

76. The method of claim 71, wherein ablating tissue further includes

varying the frequency of said power provided to one or more of said transducers.