Apparatus and method for an ultrasonic probe used with a pharmacological agent

• US 6,733,451 B2
• Filed: 03/25/2003
• Issued: 05/11/2004
• Est. Priority Date: 10/05/1999
• Status: Expired due to Term

• Current Assignee: Cybersonics, Inc
• Original Assignee: OmniSonics Medical Technologies, Inc.
• Inventors: Buffen, Elaine S., Senseney-Mellor, Heather L., Gosnell, Mark R., Rabiner, Robert A., Hare, Bradley A., Marciante, Rebecca I.
• Primary Examiner(s): FUQUA, SHAWNTINA T
• Application Number:
  US10/396,914
• Publication Number:
  US 20030181812A1
• Time in Patent Office: 413 Days
• Field of Search: 600/459, 600/439, 600/462-464, 600/466-467, 600/471-472, 604/20-22, 606/169-171, 606/159, 606/167
• US Class Current: 600/439
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 2017/00137 Details of operation mode
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/22002 preventing restenosis
• CPC Class Codes: A61B 2017/22007 Cavitation or pseudocavitation, i.e. creation of gas bubbles generating a secondary shock wave when collapsing
• CPC Class Codes: A61B 2017/22008 used or promoted
• CPC Class Codes: A61B 2017/22015 with details of the transmission member
• CPC Class Codes: A61B 2017/22018 segmented along its length
• CPC Class Codes: A61B 2017/320069 for ablating tissue
• CPC Class Codes: A61B 2017/320084 Irrigation sleeves
• CPC Class Codes: A61B 2017/320089 node location
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

The present invention provides an apparatus and a method of using an ultrasonic probe with a pharmacological agent to enhance an occlusion treating effect of the ultrasonic probe to effectively remove an occlusion. The pharmacological agent is released through a catheter to treat the occlusion and enhance an effect of a transverse ultrasonic vibration of the ultrasonic probe to effectively remove the occlusion. The pharmacological agent continues to travel downstream of the site of the occlusion and work in conjunction with the ultrasonic probe to reduce the occlusion to a size that can easily be removed from the body naturally in order to prevent reformation of the occlusion and other health risks.

Claims

1. An ultrasonic medical device comprising:

an ultrasonic probe having a proximal end, a distal end and a longitudinal axis therebetween; and

a catheter surrounding a length of the longitudinal axis of the ultrasonic probe,

wherein the catheter delivers a pharmacological agent to treat an occlusion and enhance an occlusion treating effect of the ultrasonic probe to ablate the occlusion.

2. The device of claim 1 wherein the occlusion comprises a biological material.

3. The device of claim 1 wherein the pharmacological agent is localized at the occlusion.

4. The device of claim 1 wherein the pharmacological agent softens the occlusion.

5. The device of claim 1 wherein a section of the longitudinal axis of the ultrasonic probe is located outside of a distal end of the catheter.

6. The device of claim 1 wherein the pharmacological agent is a tissue plasminogen activator.

7. The device of claim 1 wherein the pharmacological agent is selected from a group consisting of thrombolytic agents, antiplatelet drugs, lysing agents, anticoagulants, and similar agents that treat the occlusion.

8. The device of claim 1 wherein the pharmacological agent is selected from a group consisting of aspirin, dipyridamole, glycoprotein inhibitors, thienopyrindines, clopidogrel, hirudin, urokinase, streptokinase, heparin, warfarin and similar agents that treat the occlusion.

9. The device of claim 1 wherein the catheter has an at least one fenestration along a length of the catheter.

10. The device of claim 1 wherein the catheter has a plurality of fenestrations along a length of the catheter.

11. The device of claim 1 wherein the pharmacological agent moves through a plurality of fenestrations located along a length of the catheter.

12. The device of claim 1 wherein the pharmacological agent moves through an opening at a distal end of the catheter.

13. The device of claim 1 wherein a diameter of the ultrasonic probe is approximately uniform along the longitudinal axis of the ultrasonic probe.

14. The device of claim 1 wherein a diameter of the ultrasonic probe varies from the proximal end of the ultrasonic probe to the distal end of the ultrasonic probe.

15. The device of claim 1 wherein a cross section of the ultrasonic probe has a small profile.

16. The device of claim 1 wherein a length and a cross section of the ultrasonic probe are sized to support a transverse ultrasonic vibration with a plurality of transverse nodes and transverse anti-nodes along a portion of the longitudinal axis of the ultrasonic probe wherein more than one of the plurality of transverse anti-nodes are in communication with the occlusion.

17. The device of claim 1 wherein the ultrasonic probe is for a single use on a single patient.

18. The device of claim 1 wherein the ultrasonic probe is disposable.

19. The device of claim 1 wherein the ultrasonic probe has a stiffness that gives the ultrasonic probe a flexibility to be articulated in a vasculature.

20. An ultrasonic medical device for ablating an occlusion comprising:

an elongated, flexible probe having a proximal end, a distal end and a longitudinal axis therebetween; and

a catheter surrounding a length of the longitudinal axis of the elongated, flexible probe,

wherein a pharmacological agent moves through the catheter to enhance an effect of a transverse ultrasonic vibration of the elongated, flexible probe to ablate the occlusion.

21. The device of claim 20 wherein the occlusion comprises a biological material.

22. The device of claim 20 wherein the pharmacological agent softens the occlusion.

23. The device of claim 20 wherein the elongated, flexible probe supports the transverse ultrasonic vibration along a portion of the longitudinal axis of the elongated, flexible probe to remove the occlusion.

24. The device of claim 20 wherein the transverse ultrasonic vibration of the elongated, flexible probe produces a plurality of transverse nodes and transverse anti-nodes along a portion of the longitudinal axis of the elongated, flexible probe.

25. The device of claim 24 wherein the transverse anti-nodes are points of a maximum transverse energy along a portion of the longitudinal axis of the elongated, flexible probe.

26. The device of claim 24 wherein the transverse anti-nodes cause a cavitation in a medium in communication with the elongated, flexible probe.

27. The device of claim 24 wherein more than one of the plurality of transverse anti-nodes are in communication with the occlusion.

28. The device of claim 20 wherein the pharmacological agent is a tissue plasminogen activator.

29. The device of claim 20 wherein the pharmacological agent is selected from a group consisting of thrombolytic agents, antiplatelet drugs, lysing agents, anticoagulants, and similar agents that treat the occlusion.

30. The device of claim 20 wherein the pharmacological agent is selected from a group consisting of aspirin, dipyridamole, glycoprotein inhibitors, thienopyrindines, clopidogrel, hirudin, urokinase, streptokinase, heparin, warfarin and similar agents that treat the occlusion.

31. The device of claim 20 wherein the catheter has an at least one fenestration along a length of the catheter.

32. The device of claim 20 wherein the catheter has a plurality of fenestrations along a length of the catheter.

33. The device of claim 20 wherein the pharmacological agent moves through a plurality of fenestrations located along a length of the catheter.

34. The device of claim 20 wherein the pharmacological agent moves through an opening at a distal end of the catheter.

35. The device of claim 20 wherein a diameter of the elongated, flexible probe is approximately uniform along the longitudinal axis of the elongated, flexible probe.

36. The device of claim 20 wherein a diameter of the elongated, flexible probe varies from the proximal end of the elongated, flexible probe to the distal end of the elongated, flexible probe.

37. The device of claim 20 wherein the elongated, flexible probe has a stiffness that gives the elongated, flexible probe a flexibility to be articulated in a vasculature.

38. A method of treating an occlusion comprising:

inserting an ultrasonic probe in a vasculature of a body;

delivering a catheter over a length of a longitudinal axis of the ultrasonic probe;

releasing a pharmacological agent through the catheter;

exposing a section of the longitudinal axis of the ultrasonic probe to the occlusion; and

activating an ultrasonic source to provide an ultrasonic energy to the ultrasonic probe wherein the pharmacological agent enhances an occlusion treating effect of the ultrasonic probe by working in combination with the ultrasonic probe at a site of the occlusion and downstream of the site of the occlusion.

39. The method of claim 38 wherein the occlusion comprises a biological material.

40. The method of claim 38 wherein the pharmacological agent is localized at the occlusion.

41. The method of claim 38 wherein the pharmacological agent engages the occlusion and moves downstream of the site of the occlusion.

42. The method of claim 38 wherein the combination of the ultrasonic energy from the ultrasonic probe and the pharmacological agent breaks up the occlusion into a particulate downstream of the site of the occlusion.

43. The method of claim 42 wherein the combination of the ultrasonic energy from the ultrasonic probe and the pharmacological agent breaks up the particulate into an aggregate downstream of the site of the occlusion.

44. The method of claim 38 wherein the ultrasonic probe is a wire.

45. The method of claim 38 wherein the ultrasonic probe is moved to a site of the occlusion and remains proximal to the site of the occlusion.

46. The method of claim 38 wherein the pharmacological agent is a tissue plasminogen activator.

47. The method of claim 38 wherein the pharmacological agent is selected from a group consisting of thrombolytic agents, antiplatelet drugs, lysing agents, anticoagulants, and similar agents that treat the occlusion.

48. The device of claim 38 wherein the pharmacological agent is selected from a group consisting of aspirin, dipyridamole, glycoprotein inhibitors, thienopyrindines, clopidogrel, hirudin, urokinase, streptokinase, heparin, warfarin and similar agents that treat the occlusion.

49. The method of claim 38 wherein the catheter has an at least one fenestration along a length of the catheter.

50. The method of claim 38 wherein the catheter has a plurality of fenestrations along a length of the catheter.

51. The method of claim 50 wherein the pharmacological agent moves through the plurality of fenestrations located along the length of the catheter.

52. The method of claim 38 wherein the pharmacological agent moves through an opening at a distal end of the catheter.

53. The method of claim 38 wherein a diameter of the ultrasonic probe is approximately uniform along the longitudinal axis of the ultrasonic probe.

54. The method of claim 38 wherein a diameter of the ultrasonic probe varies from a proximal end of the ultrasonic probe to a distal end of the ultrasonic probe.

55. The method of claim 38 wherein a cross section of the ultrasonic probe has a small profile.

56. The method of claim 38 wherein a length and a cross section of the ultrasonic probe are sized to support a transverse ultrasonic vibration with a plurality of transverse nodes and transverse anti-nodes along a portion of the longitudinal axis of the ultrasonic probe wherein more than one of the plurality of transverse anti-nodes are in communication with the occlusion.

57. The method of claim 38 wherein the ultrasonic probe is for a single use on a single patient.

58. The method of claim 38 wherein a section of the longitudinal axis of the ultrasonic probe is exposed by moving the section of the longitudinal axis of the ultrasonic probe past a distal end of the catheter.

59. The method of claim 38 wherein the section of the longitudinal axis of the ultrasonic probe is exposed by pulling back on the catheter.

60. The method of claim 38 wherein the ultrasonic probe is disposable.

61. A method of removing an occlusion comprising:

moving an elongated, flexible probe through a vasculature to a site of the occlusion;

releasing a pharmacological agent in the vasculature having the occlusion to enhance an occlusion removing effect of the elongated, flexible probe; and

activating an ultrasonic energy source to vibrate a longitudinal axis of the elongated, flexible probe in a transverse direction to remove the occlusion.

62. The method of claim 61 wherein a catheter surrounds a length of the longitudinal axis of the elongated, flexible probe.

63. The method of claim 61 wherein a section of the longitudinal axis of the elongated, flexible probe is exposed to the occlusion.

64. The method of claim 61 wherein the pharmacological agent engages an occlusion and moves downstream from the site of the occlusion.

65. The method of claim 61 wherein a combination of an ultrasonic energy from the elongated, flexible probe and the pharmacological agent breaks up the occlusion into a particulate downstream from the site of the occlusion.

66. The method of claim 61 wherein a combination of an ultrasonic energy from the elongated, flexible probe and the pharmacological agent breaks up a particulate into an aggregate downstream from the site of the occlusion.

67. The method of claim 61 wherein a length and a cross section of the elongated, flexible probe are sized to support a transverse ultrasonic vibration with a plurality of transverse nodes and transverse anti-nodes along a portion of the longitudinal axis of the elongated, flexible probe wherein more than one of the plurality of transverse anti-nodes are in communication with the occlusion.

68. The method of claim 61 wherein the elongated, flexible probe has a stiffness that gives the elongated, flexible probe a flexibility to be articulated in the vasculature.