Focused ultrasound ablation devices having selectively actuatable emitting elements and methods of using the same

• US 7,615,015 B2
• Filed: 06/20/2003
• Issued: 11/10/2009
• Est. Priority Date: 01/19/2000
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Coleman, R. Glen
• Primary Examiner(s): Le; Long V
• Assistant Examiner(s): Cheng; Jacqueline
• Application Number:
  US10/600,871
• Publication Number:
  US 20040015106A1
• Time in Patent Office: 2,335 Days
• Field of Search: 600/439, 600/471, 600/472, 601 1- 4, 606 27- 31
• US Class Current: 601/3
• CPC Class Codes: A61H 23/0236 using sonic waves, e.g. using loudspeakers
• CPC Class Codes: A61N 2007/0065 Concave transducers
• CPC Class Codes: A61N 2007/0078 with multiple treatment transducers
• CPC Class Codes: A61N 2007/027 with multiple foci created simultaneously
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

A focused ultrasound ablation device and method includes an ultrasound emitting member having a plurality of individual ultrasound emitting elements arranged in an array. The ultrasound emitting elements are actuatable to emit ultrasound energy and focus the emitted ultrasound energy a predetermined distance from the ultrasound emitting member such that the ultrasound energy is focused within anatomical tissue adjacent which the ultrasound emitting member is positioned. The anatomical tissue is heated by the ultrasound energy focused therein to form an internal lesion within the tissue. The ultrasound emitting elements are selectively, independently actuatable, allowing selected ones of the ultrasound emitting elements to be actuated to emit ultrasound energy to obtain a lesion of desired or selected size and/or surface configuration in the tissue of a particular patient.

Claims

1. A focused ultrasound ablation device for creating a lesion in tissue of a patient comprising:

an ultrasound emitting member having a plurality of individual ultrasound emitting elements spaced from one another, the ultrasound emitting elements being actuatable to emit ultrasound energy a predetermined distance outwardly from an active surface whereby the ultrasound energy is focused within tissue of the patient at separate and distinct locations for each individual ultrasound emitting element to form a lesion, the ultrasound emitting elements being selectively, independently actuatable to emit ultrasound energy and being selectively, independently non-actuatable to not emit ultrasound energy whereby a lesion of selected size and configuration is formed in accordance with the positions of the ultrasound emitting elements selected to be actuated; and

a handle coupled to said ultrasound emitting member.

2. The device of claim 1 wherein the ultrasound emitting elements each include a piezoelectric element that emits ultrasound energy in response to electric current selectively supplied thereto.

3. The device of claim 2 wherein the piezoelectric elements are curved to effect focusing of the ultrasound energy a predetermined distance outwardly from the active surface.

4. The device of claim 1 wherein the handle has a sufficient length to position the ultrasound emitting member adjacent tissue in the patient while the handle is maintained external of the patient.

5. The device of claim 1 wherein the handle includes a malleable shaft.

6. The device of claim 1 wherein the handle has a configuration to facilitate grasping by a surgeon or other operator.

7. The device of claim 1 wherein the handle includes one or more controls or switches.

8. The device of claim 7 wherein the one or more controls or switches actuate the emission of ultrasound energy from the ultrasound emitting elements.

9. The focused ultrasound ablation device of claim 1 wherein the ultrasound emitting member further comprises a flexible active surface.

10. The focused ultrasound ablation device of claim 1 wherein the handle is malleable.

11. The focused ultrasound ablation device of claim 1 wherein the plurality of ultrasound emitting elements are arranged in an annular array.

12. The focused ultrasound ablation device of claim 1 wherein the plurality of ultrasound emitting elements are arranged in a linear array.

13. The focused ultrasound ablation device of claim 1 wherein the plurality of ultrasound emitting elements are arranged in a curved linear array.

14. The focused ultrasound ablation device of claim 1 wherein the ultrasound emitting elements emit ultrasound energy at a frequency, wherein the frequency is selectively variable.

15. The focused ultrasound ablation device of claim 1 further comprising a power supply removably coupled to the plurality of individual ultrasound emitting elements and the handle.

16. A focused ultrasound ablation device for creating a lesion within tissue of a patient comprising:

a handle; and

an ultrasound emitting member coupled to the handle, the ultrasound emitting member comprising an active face adapted for positioning adjacent an area of tissue, the active face carrying one or more rows of spaced apart ultrasound transducer elements, the ultrasound transducer elements selectively, independently actuatable to emit focused ultrasound energy focused a predetermined distance from the active face and focused at separate and distinct locations for each individual ultrasound transducer element such that the area of tissue adjacent the active face is heated by the focused ultrasound energy to create the lesion within tissue of the patient.

17. The device of claim 16 wherein each of the ultrasound transducer elements includes a piezoelectric element.

18. The device of claim 16 further comprising a power supply coupled to said ultrasound emitting member for generating an electric signal capable of actuating the ultrasound transducer elements to emit focused ultrasound energy.

19. The device of claim 18 further comprising a control unit coupled with the ultrasound emitting member for connecting selected ones of said ultrasound transducer elements with the electrical signal.

20. The focused ultrasound ablation device of claim 18 wherein the power supply is removably coupled to the ultrasound emitting member and the handle.

21. The device of claim 16 wherein the handle includes an elongate shaft.

22. The device of claim 16 wherein the ultrasound emitting elements each include a piezoelectric element that emits ultrasound energy in response to electric current selectively supplied thereto.

23. The device of claim 22 wherein the piezoelectric elements are curved to effect focusing of the ultrasound energy a predetermined distance outwardly from the active surface.

24. The device of claim 16 wherein the handle has a sufficient length to position the ultrasound emitting member adjacent tissue in the patient while the handle is maintained external of the patient.

25. The device of claim 16 wherein the handle includes a malleable shaft.

26. The device of claim 16 wherein the handle has a configuration to facilitate grasping by a surgeon or other operator.

27. The device of claim 16 wherein the handle includes one or more controls or switches.

28. The device of claim 27 wherein the one or more controls or switches are for actuation to emit ultrasound energy from the ultrasound emitting elements.

29. The focused ultrasound ablation device of claim 16 wherein the active surface is flexible.

30. The focused ultrasound ablation device of claim 16 wherein the plurality of ultrasound emitting elements are arranged in an annular array.

31. The focused ultrasound ablation device of claim 16 wherein the plurality of ultrasound emitting elements are arranged in a linear array.

32. The focused ultrasound ablation device of claim 16 wherein the plurality of ultrasound emitting elements are arranged in a curved linear array.

33. The focused ultrasound ablation device of claim 16 wherein the ultrasound emitting elements emit ultrasound energy at a frequency, wherein the frequency is selectively variable.

34. A method of creating an ablation lesion within tissue of a patient comprising:

grasping a handle coupled to an ultrasound emitting member;

selecting one or more of a plurality of ultrasound emitting elements, arranged in an array on an active face of the ultrasound emitting member, for actuation to emit ultrasound energy;

positioning the active face adjacent tissue of the patient;

actuating the selected one or more ultrasound emitting elements to emit ultrasound energy;

focusing the ultrasound energy with the selected one or more of the ultrasound emitting elements so that the ultrasound energy is focused a predetermined distance from the active face and focused at separate and distinct locations for each individual ultrasound emitting element; and

heating the tissue with the focused ultrasound energy to create the ablation lesion.

35. The method of claim 34 wherein the ultrasound emitting elements emit ultrasound energy in response to an electrical signal supplied thereto and the step of actuating includes electrically coupling the selected one or more of the ultrasound emitting elements with an electrical signal source.

36. The method of claim 35 wherein the step of electrically coupling includes electrically coupling the selected one or more of the ultrasound emitting elements with a power supply producing the electrical signal.

37. The focused ultrasound ablation device of claim 36 wherein the power supply is removably coupled to the plurality of individual ultrasound emitting elements and the handle.

38. The method of claim 34 wherein the step of selecting includes selecting a plurality of ultrasound emitting elements to form a continuous lesion.

39. The method of claim 34 wherein the step of selecting includes selecting a plurality of ultrasound emitting elements to form a discontinuous lesion.

40. The method of claim 34 wherein the step of selecting includes selecting a plurality of ultrasound emitting elements to form a lesion comprising a plurality of disconnected lesion segments.

41. The method of claim 34 wherein the handle has a sufficient length for positioning the active face adjacent tissue within the patient while the handle is maintained external of the patient.

42. The method of claim 34 wherein the active face is flexible, and further comprising the step of flexing the active surface.

43. The method of claim 34 wherein the handle is malleable, and further comprising the step of flexing the handle.

44. The focused ultrasound ablation device of claim 34 wherein the plurality of ultrasound emitting elements are arranged in an annular array.

45. The focused ultrasound ablation device of claim 34 wherein the plurality of ultrasound emitting elements are arranged in a linear array.

46. The focused ultrasound ablation device of claim 34 wherein the plurality of ultrasound emitting elements are arranged in a curved linear array.

47. The focused ultrasound ablation device of claim 34 wherein the ultrasound emitting elements emit ultrasound energy at a frequency, wherein the frequency is selectively variable.

48. A focused ultrasound ablation device for creating a lesion in tissue of a patient comprising:

an ultrasound emitting member having a plurality of ultrasound emitting elements, the ultrasound emitting elements being independently actuatable to emit ultrasound energy outwardly from an active surface and being independently non-actuatable to not emit ultrasound energy, whereby the ultrasound energy is focused at separate and distinct locations for each individual ultrasound emitting element;

a controller that selectively, independently actuates the ultrasound emitting elements to emit ultrasound energy, whereby a lesion of selected size and configuration is formed in accordance with the ultrasound emitting elements selected to be actuated.

49. The device of claim 48 wherein the ultrasound emitting elements each include a piezoelectric element that emits ultrasound energy in response to electric current selectively supplied thereto.

50. The device of claim 49 wherein the piezoelectric elements are curved to effect focusing of the ultrasound energy a predetermined distance outwardly from the active surface.

51. The device of claim 48, further comprising a malleable shaft operatively coupled to said ultrasound emitting member.

52. The focused ultrasound ablation device of claim 48 wherein the active surface is flexible in order to conform to a surface of the tissue of the patient.

53. The focused ultrasound ablation device of claim 48 wherein the plurality of ultrasound emitting elements are arranged in an annular array.

54. The focused ultrasound ablation device of claim 48 wherein the plurality of ultrasound emitting elements are arranged in a linear array.

55. The focused ultrasound ablation device of claim 48 wherein the plurality of ultrasound emitting elements are arranged in a curved linear array.

56. The focused ultrasound ablation device of claim 48 wherein the ultrasound emitting elements emit ultrasound energy at a frequency, wherein the frequency is selectively variable.

57. The focused ultrasound ablation device of claim 48 further comprising a power supply removably coupled to the plurality of individual ultrasound emitting elements and the handle.

58. A focused ultrasound ablation device for creating a lesion within tissue of a patient comprising:

an ultrasound emitting member, the ultrasound emitting member comprising an active face adapted for positioning adjacent an area of tissue, the active face carrying one or more rows of spaced apart ultrasound transducer elements, the ultrasound transducer elements selectively, independently actuatable to emit ultrasound energy focused at separate and distinct locations for each individual ultrasound transducer element such that the area of tissue adjacent the active face is heated by the ultrasound energy to create the lesion within tissue of the patient; and

a controller operatively coupled to the ultrasound transducer elements, the controller selectively actuating the ultrasound transducer elements.

59. The device of claim 58 wherein each of the ultrasound transducer elements includes a piezoelectric element.

60. The device of claim 58 further comprising a power supply coupled to said ultrasound emitting member for generating an electric signal capable of actuating the ultrasound transducer elements to emit ultrasound energy.

61. The device of claim 60 further comprising a control unit coupled with the ultrasound emitting member for connecting selected ones of said ultrasound transducer elements with the electrical signal.

62. The focused ultrasound ablation device of claim 60 wherein the power supply is removably coupled to the ultrasound emitting member and the handle.

63. The device of claim 58, further comprising an elongate malleable shaft coupled to the ultrasound emitting member.

64. The device of claim 63 wherein the handle has a sufficient length to position the ultrasound emitting member adjacent tissue in the patient.

65. The device of claim 58 wherein the ultrasound emitting elements each include a piezoelectric element that emits ultrasound energy in response to electric current selectively supplied thereto.

66. The device of claim 65 wherein the piezoelectric elements are curved to effect focusing of the ultrasound energy a predetermined distance outwardly from the active surface.

67. The focused ultrasound ablation device of claim 58 wherein the active surface is flexible in order to conform to a surface of the tissue of the patient.

68. The focused ultrasound ablation device of claim 58 wherein the plurality of ultrasound emitting elements are arranged in an annular array.

69. The focused ultrasound ablation device of claim 58 wherein the plurality of ultrasound emitting elements are arranged in a linear array.

70. The focused ultrasound ablation device of claim 58 wherein the plurality of ultrasound emitting elements are arranged in a curved liner array.

71. The focused ultrasound ablation device of claim 58 wherein the ultrasound emitting elements emit ultrasound energy at a frequency, wherein the frequency is selectively variable.

72. A method of creating an ablation lesion within tissue of a patient comprising:

selecting one or more of a plurality of ultrasound emitting elements, arranged in an array on an active face of an ultrasound emitting member, for actuation to emit ultrasound energy;

positioning the active face adjacent tissue of the patient;

actuating the selected one or more ultrasound emitting elements to emit ultrasound energy;

focusing the ultrasound energy with the selected one or more of the ultrasound emitting elements so that the ultrasound energy is focused a predetermined distance from the active face and focused at separate and distinct locations for each individual ultrasound emitting element; and

heating the tissue with the focused ultrasound energy to create the ablation lesion.

73. The method of claim 72 wherein the ultrasound emitting elements emit ultrasound energy in response to an electrical signal supplied thereto and the step of actuating includes electrically coupling the selected one or more of the ultrasound emitting elements with an electrical signal source.

74. The method of claim 73 wherein the step of electrically coupling includes electrically coupling the selected one or more of the ultrasound emitting elements with a power supply producing the electrical signal.

75. The focused ultrasound ablation device of claim 74 wherein the power supply is removably coupled to the plurality of individual ultrasound emitting elements.

76. The method of claim 72 wherein the step of selecting includes selecting a plurality of ultrasound emitting elements to form a continuous lesion.

77. The method of claim 72 wherein the step of selecting includes selecting a plurality of ultrasound emitting elements to form a discontinuous lesion.

78. The method of claim 72 wherein the step of selecting includes selecting a plurality of ultrasound emitting elements to form a lesion comprising a plurality of disconnected lesion segments.

79. The method of claim 72, further comprising the step of grasping an elongate malleable shaft coupled to the ultrasound emitting member, wherein the handle has a sufficient length for positioning the active face adjacent tissue within the patient.

80. The method of claim 72 wherein the active face is flexible, and further comprising the step of flexing the active surface.

81. The focused ultrasound ablation device of claim 72 wherein the plurality of ultrasound emitting elements are arranged in an annular array.

82. The focused ultrasound ablation device of claim 72 wherein the plurality of ultrasound emitting elements are arranged in a linear array.

83. The focused ultrasound ablation device of claim 72 wherein the plurality of ultrasound emitting elements are arranged in a curved liner array.

84. The focused ultrasound ablation device of claim 72 wherein the ultrasound emitting elements emit ultrasound energy at a selectively variable frequency, further comprising the step of varying the frequency.

85. A focused ultrasound ablation device for creating a lesion in tissue of a patient comprising:

a transducer having a plurality of ultrasound emitting elements, the ultrasound emitting elements being independently actuatable to emit ultrasound energy outwardly from an active surface and being independently non-actuatable to not emit ultrasound energy, whereby the ultrasound energy is focused at separate and distinct locations for each individual ultrasound emitting element; and

a controller that selectively, independently actuates the ultrasound emitting elements to emit ultrasound energy, whereby a lesion of selected size and configuration is formed in accordance with the ultrasound emitting elements selected to be actuated.

86. The device of claim 85 wherein the ultrasound emitting elements each include a piezoelectric element that emits ultrasound energy in response to electric current selectively supplied thereto.

87. The device of claim 86 wherein the piezoelectric elements are curved to effect focusing of the ultrasound energy a predetermined distance outwardly from the active surface.

88. The device of claim 85, further comprising a an elongate malleable shaft coupled to said transducer, wherein the elongate malleable shaft has a sufficient length to position the transducer adjacent tissue in the patient.

89. The focused ultrasound ablation device of claim 85 wherein the transducer is flexible in order to conform with a surface of the tissue of the patient.

90. The focused ultrasound ablation device of claim 85 wherein the plurality of ultrasound emitting elements are arranged in an annular array.

91. The focused ultrasound ablation device of claim 85 wherein the plurality of ultrasound emitting elements are arranged in a linear array.

92. The focused ultrasound ablation device of claim 85 wherein the plurality of ultrasound emitting elements are arranged in a curved liner array.

93. The focused ultrasound ablation device of claim 85 wherein the ultrasound emitting elements emit ultrasound energy at a frequency, wherein the frequency is selectively variable.

94. The focused ultrasound ablation device of claim 85 further comprising a power supply removably coupled to the plurality of individual ultrasound emitting elements.

95. The focused ultrasound ablation device of claim 85 wherein the transducer is flexible and the plurality of ultrasound emitting elements are arranged in a curved linear array in order to conform with a surface of the tissue of the patient.