Ultrasonic probe device with rapid attachment and detachment means

• US 6,695,782 B2
• Filed: 10/11/2001
• Issued: 02/24/2004
• Est. Priority Date: 10/05/1999
• Status: Expired due to Term

• Current Assignee: Cybersonics, Inc
• Original Assignee: OmniSonics Medical Technologies, Inc.
• Inventors: Ranucci, Kevin, Marciante, Rebecca I., Varady, Mark J., Robertson, Roy, Rabiner, Robert A., Hare, Bradley A.
• Primary Examiner(s): MANTIS MERCADER, ELENI M
• Application Number:
  US09/975,725
• Publication Number:
  US 20020055754A1
• Time in Patent Office: 866 Days
• Field of Search: 600/104, 600/121, 600/122, 600/123, 600/135, 600/139, 600/140, 600/141, 600/153, 600/154, 600/155, 600/156, 600/160-165, 600/437, 600/439, 601/2-4, 606/169, 606/46, 606/171, 606/180, 604/22
• 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 17/320068 using mechanical vibrations, e.g. ultrasonic A61B17/22012 takes precedence; dental tooth drilling devices operated by vibration A61C3/03; removing intra-ocular material using mechanical vibrations A61F9/00745
• 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 2017/00477 Coupling A61B2017/0046 takes precedence
• 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 2017/22018 segmented along its length
• CPC Class Codes: A61B 2017/320069 for ablating tissue
• CPC Class Codes: A61B 2017/32007 with suction or vacuum means
• 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 2007/0008 Destruction of fat cells
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

An ultrasonic tissue ablation device comprising a transversely vibrating elongated probe, and a coupling assembly for probe attachment detachment that enables the probe assembly and separation from the device body that includes the ultrasound energy source and a sound conductor, and a method of use for removal of vascular occlusions in blood vessels. The coupling assembly enables incorporation of elongated probes with small cross sectional lumens such as a catheter guidewires. The probe detachability allows insertion manipulation and withdrawal independently of the device body. The probe can be used with acoustic and/or aspirations sheaths to enhance destruction and removal of an occlusion. The horn assembly of the device that contains a sound conducting horn functions as an energy regulator and reservoir for the probe, and precludes loss of probe cavitation energy by its bending or damping within the blood vessel.

Claims

1. A device for removing occlusions in blood vessels comprising:

a) an ultrasonic probe having a proximal end and a distal end;

b) a probe attachment means including a coupling assembly; and

c) a sound conductor with a proximal end and a distal end, said distal end being connected to the coupling assembly and said proximal end being connected to a transducer capable of providing ultrasound energy,

wherein said ultrasonic probe is releasably mounted at said proximal end to said probe attachment means, enabling said sound conductor to transmit ultrasound energy from said transducer to said ultrasonic probe, causing said ultrasonic probe to vibrate in a direction substantially transverse to a longitudinal axis of said ultrasonic probe producing a plurality of transverse vibration anti-nodes along at least a portion of the longitudinal axis of the ultrasonic probe.

2. The device of claim 1 wherein the ultrasonic probe is a flexible elongated wire.

3. The device of claim 1 wherein the ultrasonic probe is a catheter guide wire.

4. The device of claim 1 wherein the ultrasonic probe supports a standing transverse sound wave to generate an ultrasonic cavitation energy in an at least one location along the longitudinal axis of the ultrasonic probe.

5. The device of claim 4 wherein said ultrasonic cavitation energy is preferentially enhanced at the distal end of said ultrasonic probe.

6. The device of claim 1 wherein a flexural stiffness of the ultrasonic probe varies along the longitudinal axis of the ultrasonic probe.

7. The device of claim 1 wherein the ultrasonic probe is a vascular guidewire.

8. The device of claim 1 wherein a dimension of the ultrasonic probe remains unchanged along the longitudinal axis of the ultrasonic probe.

9. The device of claim 1 wherein a length of the ultrasonic probe is between about 30 centimeters and about 300 centimeters.

10. The device of claim 1 wherein a length of the ultrasonic probe is between about 50 centimeters and about 90 centimeters.

11. The device of claim 1 further comprising a sheath assembly that includes at least one sheath extending over a portion of the ultrasonic probe.

12. The device of claim 11 wherein the sheath assembly substantially prevents transmission of a cavitational energy generated by said ultrasonic probe to a surrounding environment.

13. The device of claim 11 wherein the sheath assembly further comprises at least one fenestration.

14. The device of claim 13 wherein the fenestration is capable of transmitting a cavitation energy therethrough to a surrounding environment.

15. The device of claim 11 wherein the sheath assembly further comprises at least one reflective element.

16. The device of claim 11 wherein said sheath assembly further comprises at least one irrigation channel.

17. The device of claim 11 wherein said sheath assembly further comprises at least one aspiration channel.

18. The device of claim 11 wherein said sheath assembly further comprises at least one channel for delivering a therapeutic agent therethrough.

19. The device of claim 11 wherein said sheath assembly further comprises an imaging device.

20. The device of claim 11 wherein the sheath assembly is adapted for use with an imaging system.

21. The device of claim 11 wherein the sheath assembly is a vascular catheter comprising at least one lumen.

22. The device of claim 1 wherein the probe attachment means comprises a coupling assembly capable of connecting the longitudinal axis of the ultrasonic probe to the sound conductor and the transducer capable of vibrating at an ultrasonic frequency.

23. The device of claim 1 further comprising a handle comprising the sound conductor and the transducer.

24. The device of claim 1 wherein the sound conductor comprises a horn assembly capable of providing an impedance mismatch between said sound conductor and the ultrasonic probe.

25. The device of claim 1 wherein the coupling assembly comprises a releasable compressive clamp mounted externally to a collet residing in a housing assembly at a distal end of said coupling assembly, said collet capable of releasably engaging the ultrasonic probe.

26. The coupling assembly of claim 25 wherein the releasable compressive clamp is capable of exerting a compressive force on the collet causing said collet to engage the ultrasonic probe.

27. The device of claim 25 further comprising a plurality of attachment and detachment means of the ultrasonic probe.

28. The device of claim 1 further comprising a handle containing the probe attachment means comprising an external compressive clamp, a collet and a collet housing.

29. The device of claim 1 wherein the sound conductor connected to the coupling assembly is capable of controlling an ultrasound energy transferred to the ultrasonic probe.

30. A method of removing a vascular occlusion in a blood vessel comprising the following steps:

a) detaching an ultrasonic probe from a probe attachment means;

b) inserting the ultrasonic probe into a site of the occlusion;

c) positioning the ultrasonic probe at said site of said occlusion by a manipulation within the blood vessel having the occlusion;

d) mounting the ultrasonic probe to a coupling assembly;

e) activating a transducer to vibrate the ultrasonic probe in a direction substantially transverse to a longitudinal axis of the ultrasonic probe producing a plurality of transverse vibration anti-nodes along at least a portion of the longitudinal axis of the ultrasonic probe; and

f) detaching the ultrasonic probe from the coupling assembly upon completion of a surgical procedure and withdrawing the ultrasonic probe from the blood vessel.

31. The method of claim 30 providing the ultrasonic probe that is a flexible elongated wire.

32. The method of claim 30 providing the ultrasonic probe that is a catheter guidewire.

33. The method of claim 30 providing the ultrasonic probe that comprises a sheath assembly comprising at least one sheath.

34. The method of claim 33 providing the sheath that is capable of partially shielding a tissue at a site of a surgical procedure from said ultrasonic probe.

35. The method of claim 33 providing the sheath assembly that comprises an aspiration conduit, whereby fragments of an occlusion material are removed through said aspiration conduit.

36. The method of claim 33 wherein the sheath assembly further comprises an irrigation conduit to supply an irrigating fluid to the site of the occlusion.

37. The method of claim 33 wherein the sheath assembly comprises a conduit for delivering a therapeutic agent therethrough.

38. The method of claim 33 providing the sheath assembly that comprises an imaging system to enable positioning of said ultrasonic probe proximal to said occlusion.

39. The method of claim 33 wherein the sheath assembly is a vascular catheter comprising at least one lumen.

40. An ultrasonic medical device for removing an occlusion comprising:

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

a horn assembly engaged to the proximal end of the elongated, flexible probe; and

a coupling assembly that engages the horn assembly to the elongated, flexible probe,

wherein a transfer of energy from the horn assembly to the elongated, flexible probe produces a transverse ultrasonic vibration along at least a portion of the longitudinal length of the elongated, flexible probe, producing a plurality of transverse vibration anti-nodes along at least a portion of the longitudinal length of the elongated, flexible probe.

41. The device of claim 40 providing the elongated, flexible probe that has a small cross sectional profile that allows insertion of the elongated, flexible probe into a blood vessel.

42. The device of claim 40 wherein a diameter of the elongated, flexible probe is approximately the same along the longitudinal length of the elongated, flexible probe.

43. The device of claim 40 wherein the elongated, flexible probe has a plurality of segment intervals along the longitudinal length of the elongated, flexible probe, wherein each segment interval has a different diameter.

44. The device of claim 40 wherein the elongated flexible probe vibrates in a direction transverse to at least a portion of the longitudinal length of the elongated, flexible probe.

45. The device of claim 40 wherein at least a portion of the longitudinal length of the elongated, flexible probe has a plurality of anti-nodes.

46. The device of claim 45 wherein at least a portion of the longitudinal length of the elongated, flexible probe has an at least one anti-node that is a point of a maximum transverse ultrasonic vibration.

47. The device of claim 40 wherein a flexibility of the elongated, flexible probe allows the elongated, flexible probe to be inserted into a narrow interstice without damage to the elongated, flexible probe or the narrow interstice.

48. The device of claim 40 wherein the elongated, flexible probe is adapted to be inserted into a vascular introducer.

49. The device of claim 40 wherein the elongated, flexible probe is a single diameter wire with an approximately uniform cross section.

50. The device of claim 40 wherein the elongated, flexible probe is tapered along at least a portion of the longitudinal length of the elongated, flexible probe to control an amplitude of a transverse wave along at least a portion of the longitudinal length of the elongated, flexible probe.

51. The device of claim 40 wherein the elongated, flexible probe can support the transverse ultrasonic vibration along the longitudinal length of the elongated, flexible probe.

52. The device of claim 40 wherein the elongated, flexible probe comprises titanium.

53. The device of claim 40 wherein the coupling assembly comprises a releasable compressive clamp mounted externally to a collet residing in a housing assembly at a distal end of the coupling assembly wherein the collet is capable of releasably engaging the elongated, flexible probe.

54. The device of claim 53 wherein the releasable compressive clamp is capable of exerting a compressive force on the collet causing the collet to engage the elongated, flexible probe.

55. A method of removing an occlusion in an interstice of a body comprising:

engaging a coupling assembly to a proximal end of an elongated, flexible probe and a distal end of a horn assembly; and

transferring energy from the horn assembly to the elongated, flexible probe; and

producing a transverse ultrasonic vibration along at least a portion of a longitudinal length of the elongated, flexible probe, causing a plurality of transverse vibration anti-nodes along at least a portion of the longitudinal length of the elongated, flexible probe.

56. The method of claim 55 providing a length of the elongated, flexible probe that is inserted into the interstice of the body.

57. The method of claim 55 providing an external energy source that engages to the horn assembly at a proximal end of the horn assembly.

58. The method of claim 55 providing an energy from an external energy source that is transmitted to the horn assembly and modified by the horn assembly.

59. The method of claim 55 providing the horn assembly that transmits an energy from an external energy source to the elongated, flexible probe through the coupling assembly wherein the energy is generated from an external energy source.

60. The method of claim 55 providing the transverse ultrasonic vibration of the elongated, flexible probe that provides a plurality of anti-nodes along at least a portion of the longitudinal length of the elongated, flexible probe.

61. The method of claim 60 wherein the anti-nodes are points of maximum transverse ultrasonic vibration along at least a portion of the longitudinal length of the elongated, flexible probe.

62. The method of claim 55 providing the coupling assembly that comprises a locking nut that engages the horn assembly at the proximal end of the elongated, flexible probe.

63. The method of claim 55 providing the elongated, flexible probe that has a flexibility that allows the elongated, flexible probe to be inserted into a narrow interstice without damage to the elongated, flexible probe or the narrow interstice.

64. The method of claim 55 providing the elongated, flexible probe that is adapted to be inserted into a vascular introducer.

65. The method of claim 55 providing the elongated, flexible probe that is tapered along at least a portion of the longitudinal length of the elongated, flexible probe to control an amplitude of a transverse wave along at least a portion of the longitudinal length of the elongated, flexible probe.

66. The method of claim 55 providing the elongated, flexible probe that can support the transverse ultrasonic vibration along the longitudinal length of the elongated, flexible probe.

67. The method of claim 55 providing the coupling assembly that comprises a releasable compressive clamp mounted externally to a collet residing in a housing assembly at a distal end of the coupling assembly wherein the collet is capable of releasably engaging the elongated, flexible probe.

68. The method of claim 67 wherein the releasable compressive clamp is capable of exerting a compressive force on the collet causing the collet to engage the elongated, flexible probe.