Ultrasound device for axial ranging

• US 6,863,653 B1
• Filed: 10/09/1998
• Issued: 03/08/2005
• Est. Priority Date: 05/07/1997
• Status: Expired due to Fees

• Current Assignee: Eclipse Surgical Technologies, Inc. (Cryolife Incorporated)
• Original Assignee: Eclipse Surgical Technologies, Inc. (Cryolife Incorporated)
• Inventors: Rosinko, Michael J., Zanelli, Claudio I., Stone, Gregg W., Daniel, Steven A.
• Primary Examiner(s): Lateef, Marvin M.
• Assistant Examiner(s): PATEL, MAULIN M
• Application Number:
  US09/169,747
• Time in Patent Office: 2,342 Days
• Field of Search: 600/439, 600/463, 600/466, 600/467, 600/471, 600/437, 606/1, 606/7, 606/11
• US Class Current: 600/437
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/22072 with an instrument channel, e.g. for replacing one instrument by the other in cannulas A61B17/3417
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00636 Sensing and controlling the application of energy

Abstract

An apparatus for treatment of body tissue includes a treatment apparatus configured to be inserted into a patient. The treatment apparatus has a distal portion, a distal end, a proximal portion and an axis. An ultrasound transducer is positioned at the distal portion of the treatment apparatus. The ultrasound transducer includes a distal ultrasound energy delivery surface and a proximal ultrasound energy delivery surface. An ultrasound energy attenuator member is positioned adjacent to the proximal ultrasound energy delivery surface and is made of a material to at least partially attenuate ultrasound energy from the proximal ultrasound energy delivery surface.

Claims

1. An apparatus for treatment of body tissue, comprising:

a treatment apparatus configured to be inserted into a patient, the treatment apparatus including a distal portion, a distal end, a proximal portion and an axis;

a non-rotating ultrasound transducer positioned at the distal portion of the treatment apparatus, the ultrasound transducer including a distal ultrasound energy delivery surface and a proximal ultrasound energy delivery surface; and

an ultrasound energy attenuator member positioned adjacent to the proximal ultrasound energy delivery surface and made of a material to at least partially attenuate ultrasound energy from the proximal ultrasound energy delivery surface.

2. The apparatus of claim 1, wherein the ultrasound transducer is positioned to transmit ultrasound signals substantially axially aligned with the axis of the treatment apparatus to the body tissue, the ultrasound transducer further receiving return signals from the body tissue to be treated.

3. The apparatus of claim 2, further comprising:

a signal interface coupled to the ultrasound transducer, the signal interface receiving at least a portion of the return signals from the cardio vascular tissue; and

a signal processor coupled to the signal interface, the signal processor providing a real time determination of at least one surface of body tissue relative to one or more positions of the distal end of the treatment apparatus.

4. The apparatus of claim 1, wherein the ultrasound energy attenuator member attenuates ultrasound energy from the proximal ultrasound energy delivery surface in an amount of 10-30 dB.

5. The apparatus of claim 1, wherein the ultrasound energy attenuator member attenuates ultrasound energy from the proximal ultrasound energy delivery surface in an amount of 15-25 dB.

6. The apparatus of claim 1, wherein the ultrasound energy attenuator member attenuates ultrasound energy from the proximal ultrasound energy delivery surface in an amount of 20 dB.

7. The apparatus of claim 1, wherein the transducer operates in a frequency range of 1-40 MHz.

8. The apparatus of claim 1, wherein the transducer operates in a frequency range of 5-30 MHz.

9. The apparatus of claim 1, wherein the transducer operates in a frequency range of 10-20 MHz.

10. The apparatus of claim 1, wherein the ultrasound energy attenuator member attenuates ultrasound energy in an amount of at least 40 dB in a distance of 3 mm or less.

11. The apparatus of claim 1, wherein the ultrasound energy attenuator member attenuates ultrasound energy in an amount of at least 30 dB in a distance of 3 mm or less.

12. The apparatus of claim 1, wherein the ultrasound energy attenuator member attenuates ultrasound energy in an amount of at least 20 dB in a distance of 3 mm or less.

13. The apparatus of claim 1, wherein the ultrasound energy attenuator member attenuates ultrasound energy in an amount of at least 40 dB in a distance of 2 mm or less.

14. The apparatus of claim 1, wherein the ultrasound energy attenuator member attenuates ultrasound energy in an amount of at least 30 dB in a distance of 2 mm or less.

15. The apparatus of claim 1, wherein the ultrasound energy attenuator member attenuates ultrasound energy in an amount of at least 20 dB in a distance of 2 mm or less.

16. The apparatus of claim 1, wherein the ultrasound energy attenuator member has a distal end positioned adjacent to the proximal ultrasound energy delivery surface and an opposing proximal end, wherein a diameter of the attenuator member distal end is greater than a diameter of the attenuator member proximal end.

17. The apparatus of claim 1, wherein the ultrasound energy attenuator member has a tapered geometric configuration.

18. The apparatus of claim 1, wherein the ultrasound energy attenuator member includes a plurality of microspheres.

19. The apparatus of claim 1, wherein the plurality of microspheres expand upon a receipt of ultrasound energy.

20. The apparatus of claim 1, further comprising:

an electrode positioned at the distal end of the treatment apparatus.

21. The apparatus of claim 20, wherein the electrode has a tissue interface surface of sufficient size to provide a detection of an ECG signal.

22. The apparatus of claim 20, further comprising:

a multiplexer coupled to the electrode and the ultrasound transducer.

23. The apparatus of claim 22, wherein the multiplexer provides a multiplexing of a signals of the electrode and the ultrasound transducer.

24. The apparatus of claim 1, further comprising:

an energy delivery device retractably positioned in a treatment apparatus lumen.

25. The apparatus of claim 24, wherein the energy delivery device is an optical fiber.

26. The apparatus of claim 24, further comprising:

an energy delivery device retraction member coupled to the energy delivery device.

27. The apparatus of claim 26, wherein the energy delivery device retraction member is coupled to the treatment apparatus.

28. The apparatus of claim 24, wherein the energy delivery device is sufficiently retractable within the treatment apparatus lumen to permit transmission of ultrasound signals in a lateral angle of 30°

or less relative to the axis of the treatment apparatus to the body tissue, the ultrasound transducer further receiving return signals from the body tissue to be treated.

29. The apparatus of claim 24, wherein the energy delivery device is sufficiently retractable within the treatment apparatus lumen to permit transmission of ultrasound signals in a lateral angle of 20°

or less relative to the axis of the treatment apparatus to the body tissue, the ultrasound transducer further receiving return signals from the body tissue to be treated.

30. The apparatus of claim 24, wherein the energy delivery device is sufficiently retractable within the treatment apparatus lumen to permit transmission of ultrasound signals in a lateral angle of 10°

or less relative to the axis of the treatment apparatus to the body tissue, the ultrasound transducer further receiving return signals from the body tissue to be treated.

31. The apparatus of claim 24, wherein the energy delivery device is sufficiently retractable within the treatment apparatus lumen to permit transmission of ultrasound signals substantially axially aligned with the axis of the treatment apparatus to the body tissue, the ultrasound transducer further receiving return signals from the body tissue to be treated.

32. The apparatus of claim 1, wherein the treatment apparatus includes an agent delivery lumen.

33. The apparatus of claim 32, wherein the agent is an angiogenesis stimulation agent.

34. The apparatus of claim 1, further comprising:

a catheter having at least one lumen for guiding the treatment apparatus.

35. The apparatus of claim 34, wherein the catheter is sized and configured for insertion through the vasculature of the patient.

36. The apparatus of claim 1, further comprising:

an MIS apparatus having at least one lumen for guiding the treatment apparatus.

37. The apparatus of claim 1, further comprising:

a surgical handpiece having at least one lumen for insertion of the treatment apparatus therethrough.

38. The apparatus of claim 1, wherein the treatment apparatus includes a laser delivery device.

39. The apparatus of claim 38, wherein the laser delivery device includes an optical fiber.

40. The apparatus of claim 38, further comprising:

a laser energy source coupled to the laser delivery device.

41. The apparatus of claim 40, wherein the laser energy source is a holmium laser.

42. The apparatus of claim 40, wherein the laser energy source is an eximer laser.

43. The apparatus of claim 40, wherein the laser energy source is a CO₂ laser.

44. The apparatus of claim 1, wherein the treatment apparatus is a mechanical cutting apparatus suitable for performing myocardial revascularization.

45. The apparatus of claim 1, wherein the body tissue is a cardiovascular tissue.

46. The apparatus of claim 1, wherein the body tissue is a myocardium tissue.

47. The apparatus of claim 1, wherein the patient is a human patient.

48. An apparatus for treatment of body tissue, comprising:

a treatment apparatus configured to be inserted into a patient, the treatment apparatus including a distal portion, a distal end, a proximal portion and an axis;

an ultrasound transducer positioned at the distal portion of the treatment apparatus, the ultrasound transducer including a distal ultrasound energy delivery surface and a proximal ultrasound energy delivery surface; and

an electrode positioned adjacent to the ultrasound transducer at the treatment apparatus distal end.

49. The apparatus of claim 48, wherein the electrode has a tissue interface surface of sufficient size to provide a detection of an ECG signal.

50. The apparatus of claim 48, further comprising:

a multiplexer coupled to the electrode and the ultrasound transducer.

51. The apparatus of claim 50, wherein the multiplexer provides a multiplexing of a signals of the electrode and the ultrasound transducer.

52. The apparatus of claim 51, further comprising:

an energy delivery device retractably positioned in a treatment apparatus lumen.

53. The apparatus of claim 52, wherein the energy delivery device is an optical fiber.

54. The apparatus of claim 52, further comprising:

an energy delivery device retraction member coupled to the energy delivery device.

55. The apparatus of claim 54, wherein the energy delivery device retraction member is coupled to the treatment apparatus.

56. The apparatus of claim 54, wherein the energy delivery device is sufficiently retractable within the treatment apparatus lumen to permit transmission of ultrasound signals in a lateral angle of 30°

or less relative to the axis of the treatment apparatus to the body tissue, the ultrasound transducer further receiving return signals from the body tissue to be treated.

57. The apparatus of claim 54, wherein the energy delivery device is sufficiently retractable within the treatment apparatus lumen to permit transmission of ultrasound signals in a lateral angle of 20°

or less relative to the axis of the treatment apparatus to the body tissue, the ultrasound transducer further receiving return signals from the body tissue to be treated.

58. The apparatus of claim 54, wherein the energy delivery device is sufficiently retractable within the treatment apparatus lumen to permit transmission of ultrasound signals in a lateral angle of 10°

or less relative to the axis of the treatment apparatus to the body tissue, the ultrasound transducer further receiving return signals from the body tissue to be treated.

59. The apparatus of claim 54, wherein the energy delivery device is sufficiently retractable within the treatment apparatus lumen to permit transmission of ultrasound signals substantially axially aligned with the axis of the treatment apparatus to the body tissue, the ultrasound transducer further receiving return signals from the body tissue to be treated.

60. The apparatus of claim 48, wherein the treatment apparatus includes an agent delivery lumen.

61. The apparatus of claim 48, wherein the agent is an angiogenesis stimulation agent.

62. The apparatus of claim 48, further comprising:

an ultrasound energy attenuator member positioned adjacent to the proximal ultrasound energy delivery surface and made of a material to at least partially attenuate ultrasound energy from the proximal ultrasound energy delivery surface.

63. The apparatus of claim 62, wherein the ultrasound energy attenuator member attenuates ultrasound energy from the proximal ultrasound energy delivery surface in an amount of 10-30 dB.

64. The apparatus of claim 62, wherein the ultrasound energy attenuator member attenuates ultrasound energy from the proximal ultrasound energy delivery surface in an amount of 15-25 dB.

65. The apparatus of claim 62, wherein the ultrasound energy attenuator member attenuates ultrasound energy from the proximal ultrasound energy delivery surface in an amount of 20 dB.

66. The apparatus of claim 62, wherein the transducer operates in a frequency range of 1-40 MHz.

67. The apparatus of claim 62, wherein the transducer operates in a frequency range of 5-30 MHz.

68. The apparatus of claim 62, wherein the transducer operates in a frequency range of 10-20 MHz.

69. The apparatus of claim 62, wherein the ultrasound energy attenuator member attenuates ultrasound energy in an amount of at least 40 dB in a distance of 3 mm or less.

70. The apparatus of claim 62, wherein the ultrasound energy attenuator member attenuates ultrasound energy in an amount of at least 30 dB in a distance of 3 mm or less.

71. The apparatus of claim 62, wherein the ultrasound energy attenuator member attenuates ultrasound energy in an amount of at least 20 dB in a distance of 3 mm or less.

72. The apparatus of claim 62, wherein the ultrasound energy attenuator member attenuates ultrasound energy in an amount of at least 40 dB in a distance of 2 mm or less.

73. The apparatus of claim 62, wherein the ultrasound energy attenuator member attenuates ultrasound energy in an amount of at least 30 dB in a distance of 2 mm or less.

74. The apparatus of claim 62, wherein the ultrasound energy attenuator member attenuates ultrasound energy in an amount of at least 20 dB in a distance of 2 mm or less.

75. The apparatus of claim 62, wherein the ultrasound energy attenuator member has a distal end positioned adjacent to the proximal ultrasound energy delivery surface and an opposing proximal end, wherein a diameter of the attenuator member distal end is greater than a diameter of the attenuator member proximal end.

76. The apparatus of claim 62, wherein the ultrasound energy attenuator member has a tapered geometric configuration.

77. The apparatus of claim 62, wherein the ultrasound energy attenuator member includes a plurality of microspheres.

78. The apparatus of claim 60, wherein the plurality of microspheres expand upon a receipt of ultrasound energy.

79. The apparatus of claim 48, wherein the body tissue is a cardiovascular tissue.

80. The apparatus of claim 48, wherein the body tissue is a myocardium tissue.

81. The apparatus of claim 48, wherein the patient is a human patient.

82. An apparatus for treatment of body tissue, comprising:

a treatment apparatus configured to be inserted into a patient, the treatment apparatus including a distal portion, a distal end, a proximal portion, a treatment apparatus lumen and an axis;

an ultrasound transducer to transmit ultrasonic signals to body tissue positioned at the distal portion of the treatment apparatus, the ultrasound transducer including a distal ultrasound energy delivery surface and a proximal ultrasound energy delivery surface; and

a retractable energy delivery device retractably positionable in the treatment apparatus lumen.

83. The apparatus of claim 82, wherein the energy delivery device is an optical fiber.

84. The apparatus of claim 82, further comprising:

an energy delivery device retraction member coupled to the energy delivery device.

85. The apparatus of claim 84, wherein the energy delivery device retraction member is coupled to the treatment apparatus.

86. The apparatus of claim 84, wherein the energy delivery device is sufficiently retractable within the treatment apparatus lumen to permit transmission of ultrasound signals in a lateral angle of 30°

or less relative to the axis of the treatment apparatus to the body tissue, the ultrasound transducer further receiving return signals from the body tissue to be treated.

87. The apparatus of claim 84, wherein the energy delivery device is sufficiently retractable within the treatment apparatus lumen to permit transmission of ultrasound signals in a lateral angle of 20°

or less relative to the axis of the treatment apparatus to the body tissue, the ultrasound transducer further receiving return signals from the body tissue to be treated.

88. The apparatus of claim 84, wherein the energy delivery device is sufficiently retractable within the treatment apparatus lumen to permit transmission of ultrasound signals in a lateral angle of 10°

or less relative to the axis of the treatment apparatus to the body tissue, the ultrasound transducer further receiving return signals from the body tissue to be treated.

89. The apparatus of claim 84, wherein the energy delivery device is sufficiently retractable within the treatment apparatus lumen to permit transmission of ultrasound signals substantially axially aligned with the axis of the treatment apparatus to the body tissue, the ultrasound transducer further receiving return signals from the body tissue to be treated.

90. The apparatus of claim 82, wherein the treatment apparatus includes an agent delivery lumen.

91. The apparatus of claim 90, wherein the agent is an angiogenesis stimulation agent.

92. The apparatus of claim 82, further comprising:

an electrode positioned adjacent to the ultrasound transducer at the treatment apparatus distal end.

93. The apparatus of claim 92, wherein the electrode has a tissue interface surface of sufficient size to provide a detection of an ECG signal.

94. The apparatus of claim 92, further comprising:

a multiplexer coupled to the electrode and the ultrasound transducer.

95. The apparatus of claim 94, wherein the multiplexer provides a multiplexing of a signals of the electrode and the ultrasound transducer.

96. The apparatus of claim 82, further comprising:

an ultrasound energy attenuator member positioned adjacent to the proximal ultrasound energy delivery surface and made of a material to at least partially attenuate ultrasound energy from the proximal ultrasound energy delivery surface.

97. The apparatus of claim 96, wherein the ultrasound energy attenuator member attenuates ultrasound energy from the proximal ultrasound energy delivery surface in an amount of 10-30 dB.

98. The apparatus of claim 96, wherein the ultrasound energy attenuator member attenuates ultrasound energy from the proximal ultrasound energy delivery surface in an amount of 15-25 dB.

99. The apparatus of claim 96, wherein the ultrasound energy attenuator member attenuates ultrasound energy from the proximal ultrasound energy delivery surface in an amount of 20 dB.

100. The apparatus of claim 96, wherein the transducer operates in a frequency range of 1-40 MHz.

101. The apparatus of claim 96, wherein the transducer operates in a frequency range of 5-30 MHz.

102. The apparatus of claim 96, wherein the transducer operates in a frequency range of 10-20 MHz.

103. The apparatus of claim 96, wherein the ultrasound energy attenuator member attenuates ultrasound energy in an amount of at least 40 dB in a distance of 3 mm or less.

104. The apparatus of claim 96, wherein the ultrasound energy attenuator member attenuates ultrasound energy in an amount of at least 30 dB in a distance of 3 mm or less.

105. The apparatus of claim 96, wherein the ultrasound energy attenuator member attenuates ultrasound energy in an amount of at least 20 dB in a distance of 3 mm or less.

106. The apparatus of claim 96, wherein the ultrasound energy attenuator member attenuates ultrasound energy in an amount of at least 40 dB in a distance of 2 mm or less.

107. The apparatus of claim 96, wherein the ultrasound energy attenuator member attenuates ultrasound energy in an amount of at least 30 dB in a distance of 2 mm or less.

108. The apparatus of claim 96, wherein the ultrasound energy attenuator member attenuates ultrasound energy in an amount of at least 20 dB in a distance of 2 mm or less.

109. The apparatus of claim 96, wherein the ultrasound energy attenuator member has a distal end positioned adjacent to the proximal ultrasound energy delivery surface and an opposing proximal end, wherein a diameter of the attenuator member distal end is greater than a diameter of the attenuator member proximal end.

110. The apparatus of claim 96, wherein the ultrasound energy attenuator member has a tapered geometric configuration.

111. The apparatus of claim 96, wherein the ultrasound energy attenuator member includes a plurality of microspheres.

112. The apparatus of claim 96, wherein the plurality of microspheres expand upon a receipt of ultrasound energy.

113. The apparatus of claim 82, wherein the body tissue is a cardiovascular tissue.

114. The apparatus of claim 82, wherein the body tissue is a myocardium tissue.

115. The apparatus of claim 82, wherein the patient is a human patient.