Method and apparatus for treating vascular obstructions

• US 20080097251A1
• Filed: 06/15/2006
• Published: 04/24/2008
• Est. Priority Date: 06/15/2006
• Status: Abandoned Application

• Current Assignee: Eilaz Babaev
• Original Assignee: Eilaz Babaev
• Inventors: Babaev, Eilaz
• Application Number:
  US11/454,018
• Publication Number:
  US 20080097251A1
• Time in Patent Office: Days
• 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 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• 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 2018/0022 Balloons
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter

Abstract

Method and device for treating vascular obstruction using ultrasonic energy in combination with cryogenic energy and/or an expandable member is disclosed. Ultrasound energy is delivered from a specially designed ultrasound transducer that is inserted in a blood vessel. Ultrasound energy can be delivered in conjunction with cryogenic energy. Ultrasound energy can also be delivered in conjunction with an expandable member such as expandable tubing, a hinged transducer, or a balloon. Ultrasound energy can also be delivered in conjunction with both cryogenic energy and an expandable member. The use of ultrasound energy in combination with cryogenic energy and/or an expandable member can treat a vascular obstruction.

Claims

1. ) A method for ultrasonic angioplasty with an expandable member, comprising the steps of:

a) inserting an ultrasound transducer with an expandable member into a blood vessel;

b) positioning the ultrasound transducer on and/or near a vascular obstruction;

c) enlarging the expandable member; and

d) delivering ultrasound to the vicinity of a vascular obstruction;

e) wherein the ultrasound is capable of treating a vascular obstruction.

2. ) The method according to claim 1, further comprising the step of generating said ultrasound.

3. ) The method according to claim 1, wherein said ultrasound comprises low-frequency ultrasound with a frequency within the approximate range of 16 kHz-200 kHz.

4. ) The method according to claim 1, wherein said ultrasound comprises low-frequency ultrasound with a preferred frequency within the approximate range of 30 kHz-100 kHz.

5. ) The method according to claim 1, wherein said ultrasound comprises low-frequency ultrasound with a recommended frequency of approximately 80 kHz.

6. ) The method according to claim 1, wherein said ultrasound comprises medium-frequency ultrasound with a frequency within the approximate range of 200 kHz-700 kHz.

7. ) The method according to claim 1, wherein said ultrasound comprises medium-frequency ultrasound with a recommended frequency of approximately 200 kHz.

8. ) The method according to claim 1, wherein said ultrasound comprises high-frequency ultrasound with a frequency within the approximate range of 700 kHz-40 MHz.

9. ) The method according to claim 1, wherein said ultrasound comprises high-frequency ultrasound with a preferred frequency within the approximate range of 3 MHz-5 MHz.

10. ) The method according to claim 1, wherein said ultrasound comprises high-frequency ultrasound with a recommended frequency of approximately 5 MHz.

11. ) The method according to claim 1, wherein the ultrasound amplitude is at least 1 micron.

12. ) The method according to claim 1, wherein said ultrasound comprises low-frequency ultrasound with an amplitude within the approximate range of 2 microns-250 microns.

13. ) The method according to claim 1, wherein said ultrasound comprises low-frequency ultrasound with a preferred amplitude within the approximate range of 20 microns-60 microns.

14. ) The method according to claim 1, wherein said ultrasound comprises low-frequency ultrasound with a recommended amplitude of approximately 20 microns-30 microns.

15. ) The method according to claim 1, wherein said ultrasound comprises medium-frequency ultrasound with a preferred amplitude within the approximate range of 2 microns-60 microns.

16. ) The method according to claim 1, wherein said ultrasound comprises medium-frequency ultrasound with a most preferred amplitude within the approximate range of 5 microns-30 microns.

17. ) The method according to claim 1, wherein said ultrasound comprises medium-frequency 15 ultrasound with a recommended amplitude of approximately 5 microns-10 microns.

18. ) The method according to claim 1, wherein said ultrasound comprises high-frequency ultrasound with a preferred amplitude within the approximate range of 1 micron-10 microns.

19. ) The method according to claim 1, wherein said ultrasound comprises high-frequency ultrasound with a most preferred amplitude within the approximate range of 2 microns-5 microns.

20. ) The method according to claim 1, wherein enlarging the expandable member is in the manner of radially expanding an elongated tube.

21. ) The method according to claim 1, wherein enlarging the expandable member is in the manner of expanding a hinged transducer.

22. ) The method according to claim 1, wherein enlarging the expandable member is in the manner of inflating a balloon.

23. ) The method according to claim 1, wherein the ultrasound is delivered before, during, or after enlarging the expandable member, or any combination thereof.

24. ) A method for ultrasonic cryoplasty, comprising the steps of:

a) Inserting an ultrasonic transducer into a blood vessel

b) Positioning the ultrasonic transducer on or near a vascular obstruction;

c) Delivering ultrasound to the vicinity of a vascular obstruction; and

d) Delivering cryogenic energy to the vicinity of a vascular obstructioon;

e) Wherein the ultrasound is capable of treating a vascular obstruction.

25. ) The method according to claim 24, further comprising the step of generating said ultrasound.

26. ) The method according to claim 24, further comprising the step of generating said cryogenic energy wherein said generated cryogenic energy is capable of enhancing the removal of a vascular obstruction.

27. ) The method according to claim 24, wherein said ultrasound comprises low-frequency ultrasound with a frequency within the approximate range of 16 kHz-200 kHz.

28. ) The method according to claim 24, wherein said ultrasound comprises low-frequency ultrasound with a preferred frequency within the approximate range of 30 kHz-100 kHz.

29. ) The method according to claim 24, wherein said ultrasound comprises low-frequency ultrasound with a recommended frequency of approximately 80 kHz.

30. ) The method according to claim 24, wherein said ultrasound comprises medium-frequency ultrasound with a frequency within the approximate range of 200 kHz-700 kHz.

31. ) The method according to claim 24, wherein said ultrasound comprises medium-frequency ultrasound with a recommended frequency of approximately 200 kHz.

32. ) The method according to claim 24, wherein said ultrasound comprises high-frequency ultrasound with a frequency within the approximate range of 700 kHz-40 MHz.

33. ) The method according to claim 24, wherein said ultrasound comprises high-frequency ultrasound with a preferred frequency within the approximate range of 3 MHz-5 MHz.

34. ) The method according to claim 24, wherein said ultrasound comprises high-frequency ultrasound with a recommended frequency of approximately 5 MHz.

35. ) The method according to claim 24, wherein the ultrasound amplitude is at least 1 micron.

36. ) The method according to claim 24, wherein said ultrasound comprises low-frequency ultrasound with an amplitude within the approximate range of 2 microns-250 microns.

37. ) The method according to claim 24, wherein said ultrasound comprises low-frequency ultrasound with a preferred amplitude within the approximate range of 20 microns-60 microns.

38. ) The method according to claim 24, wherein said ultrasound comprises low-frequency ultrasound with a recommended amplitude of approximately 20 microns-30 microns.

39. ) The method according to claim 24, wherein said ultrasound comprises medium-frequency ultrasound with a preferred amplitude within the approximate range of 2 microns-60 microns.

40. ) The method according to claim 24, wherein said ultrasound comprises medium-frequency ultrasound with a most preferred amplitude within the approximate range of 5 microns-30 microns.

41. ) The method according to claim 24, wherein said ultrasound comprises medium-frequency ultrasound with a recommended amplitude of approximately 5 microns-10 microns.

42. ) The method according to claim 24, wherein said ultrasound comprises high-frequency ultrasound with a preferred amplitude within the approximate range of 1 micron -10 microns.

43. ) The method according to claim 24, wherein said ultrasound comprises high-frequency ultrasound with a most preferred amplitude within the approximate range of 2 microns-5 microns.

44. ) The method according to claim 24, wherein the ultrasound is delivered before, during, or after the delivery of the cryogenic energy, or any combination thereof.

45. ) A method for ultrasonic cryoplasty with an expandable member, comprising the steps of:

a) Inserting an ultrasound transducer into a blood vessel;

b) Positioning the ultrasound transducer on or near a vascular obstruction;

c) Enlarging an expandable member;

d) Delivering ultrasound to the vicinity of a vascular obstruction; and

e) Delivering cryogenic energy to the vicinity of a vascular obstruction.

f) Wherein the ultrasound is capable of treating a vascular obstruction.

46. ) The method according to claim 45, further comprising the step of generating said ultrasound.

47. ) The method according to claim 45, further comprising the step of generating cryogenic energy, wherein said cryogenic energy is capable of enhancing the treatment of a vascular obstruction.

48. ) The method according to claim 45, wherein said ultrasound comprises low-frequency ultrasound with a frequency within the approximate range of 16 kHz-200 kHz.

49. ) The method according to claim 45, wherein said ultrasound comprises low-frequency ultrasound with a preferred frequency within the approximate range of 30 kHz-10 kHz.

50. ) The method according to claim 45, wherein said ultrasound comprises low-frequency ultrasound with a recommended frequency of approximately 80 kHz.

51. ) The method according to claim 45, wherein said ultrasound comprises medium-frequency ultrasound with a frequency within the approximate range of 200 kHz-700 kHz.

52. ) The method according to claim 45, wherein said ultrasound comprises medium-frequency ultrasound with a recommended frequency of approximately 200 kHz.

53. ) The method according to claim 45, wherein said ultrasound comprises high-frequency ultrasound with a frequency within the approximate range of 700 kHz-40 MHz.

54. ) The method according to claim 45, wherein said ultrasound comprises high-frequency ultrasound with a preferred frequency within the approximate range of 3 MHz-5 MHz.

55. ) The method according to claim 45, wherein said ultrasound comprises high-frequency ultrasound with a recommended frequency of approximately 5 MHz.

56. ) The method according to claim 45, wherein the ultrasound amplitude is at least 1 micron.

57. ) The method according to claim 45, wherein said ultrasound comprises low-frequency ultrasound with an amplitude within the approximate range of 2 microns-250 microns.

58. ) The method according to claim 45, wherein said ultrasound comprises low-frequency ultrasound with a preferred amplitude within the approximate range of 20 microns-60 microns.

59. ) The method according to claim 45, wherein said ultrasound comprises low-frequency ultrasound with a recommended amplitude of approximately 20 microns-30 microns.

60. ) The method according to claim 45, wherein said ultrasound comprises medium-frequency ultrasound with a preferred amplitude within the approximate range of 2 microns-60 microns.

61. ) The method according to claim 45, wherein said ultrasound comprises medium-frequency ultrasound with a most preferred amplitude within the approximate range of 5 microns-30 microns.

62. ) The method according to claim 45, wherein said ultrasound comprises medium-frequency ultrasound with a recommended amplitude of approximately 5 microns-10 microns.

63. ) The method according to claim 45, wherein said ultrasound comprises high-frequency ultrasound with a preferred amplitude within the approximate range of 1 micron -10 microns.

64. ) The method according to claim 45, wherein said ultrasound comprises high-frequency ultrasound with a most preferred amplitude within the approximate range of 2 microns-5 microns.

65. ) The method according to claim 45, wherein the ultrasound is delivered before, during, or after the delivery of the cryogenic energy, or any combination thereof.

66. ) The method according to claim 45, wherein the cryogenic energy is delivered before, during, or after enlarging of the expandable member, or any combination thereof.

67. ) The method according to claim 45, wherein the ultrasound is delivered before, during, or after enlarging of the expandable member, or any combination thereof.

68. ) The method according to claim 45, wherein enlarging the expandable member is in the manner of radially expanding an elongated tube.

69. ) The method according to claim 45, wherein enlarging the expandable member is in the manner of expanding a hinged transducer.

70. ) The method according to claim 45, wherein enlarging the expandable member is in the manner of inflating a balloon.

71. ) An ultrasound device for treating a vascular obstruction, comprised of

a) an ultrasound power source and a transducer for producing ultrasound energy;

b) wherein the ultrasound transducer is specially designed for insertion into a blood vessel;

c) wherein the ultrasound transducer delivers ultrasound energy to the vicinity of a vascular obstruction; and

d) wherein the ultrasound is capable of treating a vascular obstruction.

72. ) The apparatus according to claim 71, wherein the power source and transducer generate the ultrasound energy with particular ultrasound parameters indicative of an intensity capable of treating a vascular obstruction.

73. ) The method according to claim 71, wherein said ultrasound comprises low-frequency ultrasound with a frequency within the approximate range of 16 kHz-200 kHz.

74. ) The method according to claim 71, wherein said ultrasound comprises low-frequency ultrasound with a preferred frequency within the approximate range of 30 kHz-10 kHz.

75. ) The method according to claim 71, wherein said ultrasound comprises low-frequency ultrasound with a recommended frequency of approximately 80 kHz.

76. ) The method according to claim 71, wherein said ultrasound comprises medium-frequency ultrasound with a frequency within the approximate range of 200 kHz-700 kHz.

77. ) The method according to claim 71, wherein said ultrasound comprises medium-frequency ultrasound with a recommended frequency of approximately 200 kHz.

78. ) The method according to claim 71, wherein said ultrasound comprises high-frequency ultrasound with a frequency within the approximate range of 700 kHz-40 MHz.

79. ) The method according to claim 71, wherein said ultrasound comprises high-frequency ultrasound with a preferred frequency within the approximate range of 3 MHz-5 MHz.

80. ) The method according to claim 71, wherein said ultrasound comprises high-frequency ultrasound with a recommended frequency of approximately 5 MHz.

81. ) The method according to claim 71, wherein the ultrasound amplitude is at least 1 micron.

82. ) The method according to claim 71, wherein said ultrasound comprises low-frequency ultrasound with an amplitude within the approximate range of 2 microns-250 microns.

83. ) The method according to claim 71, wherein said ultrasound comprises low-frequency ultrasound with a preferred amplitude within the approximate range of 20 microns-60 microns.

84. ) The method according to claim 71, wherein said ultrasound comprises low-frequency ultrasound with a recommended amplitude of approximately 20 microns-30 microns.

85. ) The method according to claim 71, wherein said ultrasound comprises medium-frequency ultrasound with a preferred amplitude within the approximate range of 2 microns-60 microns.

86. ) The method according to claim 71, wherein said ultrasound comprises medium-frequency ultrasound with a most preferred amplitude within the approximate range of 5 microns-30 microns.

87. ) The method according to claim 71, wherein said ultrasound comprises medium-frequency ultrasound with a recommended amplitude of approximately 5 microns-10 microns.

88. ) The method according to claim 71, wherein said ultrasound comprises high-frequency ultrasound with a preferred amplitude within the approximate range of 1 micron -10 microns.

89. ) The method according to claim 71, wherein said ultrasound comprises high-frequency ultrasound with a most preferred amplitude within the approximate range of 2 microns-5 microns.

90. ) The ultrasound device according to claim 71, wherein the power source is internal in the transducer.

91. ) The ultrasound device according to claim 71, wherein the power source is external to the transducer.

92. ) The ultrasound device according to claim 71, further comprised of a fluid source.

93. ) The ultrasound device according to claim 92, wherein the fluid source is a cryogenic source.

94. ) The ultrasound device according to claim 71, further comprised of an elongated tube connecting the ultrasound transducer to the proximal end of the ultrasound device.

95. ) The ultrasound device according to claim 71, further comprised of an expandable member.

96. ) The ultrasound device according to claim 95, wherein the expandable member is a hinged transducer.

97. ) The ultrasound device according to claim 95, wherein the expandable member is an inflatable balloon.

98. ) The ultrasound device according to claim 95, wherein the balloon is positioned on the distal end of the transducer.

99. ) The ultrasound device according to claim 95, wherein the expandable member is a radially expandable elongated tube connecting the transducer to the proximal end of the ultrasound device.

100. ) An elongated tube comprised of:

a) Outer tubing;

b) An internal lumen or lumens;

c) An internal guide wire or guide wires;

d) wherein the internal lumen or lumens are capable of delivering a fluid; and

e) wherein the guide wire or guide wires are capable of facilitating the transmission of the elongated tube through a blood vessel.

101. ) The elongated tube according to claim 100, wherein the guide wire or guide wires are solid, braided, or another similarly effective form.

102. ) The elongated tube according to claim 100, further comprised of electrical wires.

103. ) The elongated tube according to claim 100, wherein the guide wire or guide wires are electrical wires.

104. ) The elongated tube according to claim 100, wherein the outer tubing is made of an expandable material, a non-expandable material, or a combination of expandable and non-expandable material.

105. ) The elongated tube according to claim 100, further comprised of inner tubing.

106. ) The elongated tube according to claim 100, further comprised of a sheath over the outer tubing.

107. ) The elongated tube according to claim 100, wherein the sheath covers a portion of the outer tube.