Ultrasonic subcutaneous dissection tool incorporating fluid delivery

• US 20040204728A1
• Filed: 09/02/2003
• Published: 10/14/2004
• Est. Priority Date: 04/11/2003
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Haefner, Paul
• Granted Patent: US 7,566,318 B2
• Time in Patent Office: Days
• US Class Current: 606/169
• CPC Class Codes: A61B 17/3203 Fluid jet cutting instruments
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/320044 Blunt dissectors blunt suture needles A61B2017/06085
• CPC Class Codes: A61B 2017/32007 with suction or vacuum means
• CPC Class Codes: A61B 2017/320084 Irrigation sleeves
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2090/3945 Active visible markers, e.g. light emitting diodes
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61B 90/30 Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/0568 with drug delivery
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion

Abstract

Ultrasonic dissection instruments and methods provide for fluid delivery during subcutaneous dissection. An ultrasonic dissection tool includes a handle, a transducer and a dissecting member. The dissecting member extends from the distal end of the transducer, and a fluid channel system extends from at least the proximal end to the distal end of the dissecting member. The fluid channel system terminates in a port system. The port system may include one or more apertures, one or more channels, and be adapted to transport fluids such as, for example, irrigation fluids, fluids having analgesics, antibiotics, and combinations of fluids and agents.

Claims

1. A method of dissecting subcutaneous tissue, comprising:

ultrasonically dissecting subcutaneous tissue to create a path in the subcutaneous tissue;

delivering a fluid to the subcutaneous tissue during dissection; and

impelling the fluid into tissue using sonophoresis.

2. The method of claim 1, wherein the dissection is performed only in a subcutaneous tissue plane.

3. The method of claim 1, wherein a plane of dissection follows a curvature of the rib cage.

4. The method of claim 1, further comprising delivering one or more electrodes into the subcutaneous tissue path.

5. The method of claim 4, further comprising delivering a housing into the subcutaneous tissue path, wherein the housing matingly connects with the one or more electrodes.

6. The method of claim 1, further comprising advancing a sheath into the subcutaneous tissue path.

7. The method of claim 6, wherein the sheath is advanced into the subcutaneous tissue path during subcutaneous tissue dissection.

8. The method of claim 6, further comprising delivering one or more electrodes into the subcutaneous tissue path via the sheath.

9. The method of claim 6, further comprising delivering a lead to which one or more electrodes are respectively coupled into the subcutaneous tissue path via the sheath.

10. The method of claim 1, wherein delivering the fluid comprises impelling the fluid from a single ultrasonic dissection tool location or from multiple dissection tool locations.

11. The method of claim 1, wherein the fluid comprises an irrigation fluid.

12. The method of claim 1, wherein the fluid comprises a pharmacological agent.

13. The dissection system of claim 1, wherein the fluid comprises an analgesic or an anesthetic.

14. The dissection system of claim 1, wherein the fluid comprises an antibiotic or an antiseptic.

15. The method of claim 1, wherein the fluid comprises an anti-inflammatory agent or an agent that promotes hemostasis.

16. A dissection tool, comprising:

a handle;

an ultrasonic transducer connected to the handle, the ultrasonic transducer having a proximal end and a distal end, the proximal end of the ultrasound transducer coupled to the handle;

an elongated dissecting member having a proximal end and a distal end, the elongated dissecting member extending from the distal end of the ultrasonic transducer; and

a fluid channel system extending from at least the proximal end of the elongated dissecting member to the distal end of the elongated dissecting member, the fluid channel system terminating in a port system.

17. The dissection tool of claim 16, wherein the ultrasonic transducer is driven by a signal at one or more frequencies ranging between about 20 kilohertz and about 200 kilohertz.

18. The dissection tool of claim 16, wherein the ultrasonic transducer is driven by a signal at one or more frequencies ranging between about 20 kilohertz and about 50 kilohertz.

19. The dissection tool of claim 16, wherein the ultrasonic transducer is driven by a pulsed electrical signal having a duty cycle ranging between about 10% and 100%.

20. The dissection tool of claim 16, wherein the ultrasonic transducer is driven at a power level ranging between about 1 watt and about 200 watts.

21. The dissection tool of claim 16, wherein the ultrasonic transducer is mounted in the handle of the dissection tool.

22. The dissection tool of claim 16, wherein the port system comprises a plurality of apertures.

23. The dissection tool of claim 16, wherein the fluid channel system is adapted to transport an irrigation fluid.

24. The dissection tool of claim 16, wherein the fluid channel system is adapted to transport a pharmacological agent.

25. The dissection tool of claim 16, wherein the fluid channel system is adapted to transport an analgesic or an anesthetic.

26. The dissection tool of claim 16, wherein the fluid channel system is adapted to transport an antibiotic or an antiseptic.

27. A dissection tool, comprising:

a handle having a proximal end and a distal end;

an elongated dissecting member having a proximal end and a distal end, the elongated dissecting member extending from the distal end of the handle;

an ultrasonic transducer provided at the distal end of the elongated dissecting member; and

a fluid channel system extending from at least the proximal end of the elongated dissecting member to the distal end of the elongated dissecting member, the fluid channel system terminating in a port system.

28. The dissection tool of claim 27, wherein the ultrasonic transducer is driven by a signal at one or more frequencies ranging between about 0.2 megahertz and about 3 megahertz.

29. The dissection tool of claim 27, wherein the ultrasonic transducer is driven by a pulsed electrical signal having a duty cycle ranging between about 10% and 100%.

30. The dissection tool of claim 27, wherein the ultrasonic transducer is driven at a power level ranging between about 1 watt and about 200 watts.

31. The dissection tool of claim 27, wherein the port system comprises a plurality of apertures.

32. The dissection tool of claim 27, wherein the fluid channel system is adapted to transport a pharmacological agent.

33. The dissection tool of claim 27, wherein the fluid channel system is adapted to transport an analgesic or an anesthetic.

34. The dissection tool of claim 27, wherein the fluid channel system is adapted to transport an antibiotic or an antiseptic.

35. The dissection tool of claim 27, further comprising an aspiration channel extending from at least the proximal end of the elongated dissecting member to the distal end of the elongated dissecting member, the aspiration channel adapted to aspirate debris.

36. A method of dissecting subcutaneous tissue, comprising:

providing an ultrasonic dissection tool having a fluid delivery system;

dissecting subcutaneous tissue with the ultrasonic dissection tool to create a path in the subcutaneous tissue; and

delivering a fluid from the dissection tool during subcutaneous tissue dissection via a fluid delivery system.

37. The method of claim 36, further comprising aspirating debris from the path.

38. The method of claim 36, wherein the ultrasonic dissection tool comprises an ultrasonic transducer that is driven at one or more frequencies ranging between about 20 kilohertz and about 200 kilohertz.

39. The method of claim 36, wherein the ultrasonic dissection tool comprises an ultrasonic transducer that is driven at one or more frequencies of less than about 50 kilohertz.

40. The method of claim 36, wherein the ultrasonic dissection tool comprises an ultrasonic transducer that is driven at one or more frequencies ranging between about 0.2 megahertz and about 3 megahertz.

41. The method of claim 36, further comprising ultrasonically disrupting tissue or other debris in the path of the dissection tool as the dissection tool is advanced through the subcutaneous tissue using ultrasonic vibration.

42. The method of claim 36, further comprising ultrasonically liquifying tissue in the path of the dissection tool as the dissection tool is advanced through the subcutaneous tissue using ultrasonic vibration thereby creating the path.

43. The method of claim 36, further comprising ultrasonically disrupting dissected tissue or other debris in the fluid delivery system as the dissection tool is advanced through the subcutaneous tissue using ultrasonic vibration.

44. The method of claim 36, wherein the ultrasonic transducer is driven by a pulsed electrical signal having a duty cycle ranging between about 10% and 100%.

45. The method of claim 36, further comprising delivering one or more electrodes into the subcutaneous tissue path.

46. The method of claim 45, further comprising delivering a housing into the subcutaneous tissue path, wherein the housing matingly connects with the one or more electrodes.

47. The method of claim 45, further comprising advancing a sheath into the subcutaneous tissue path.

48. The method of claim 47, wherein the sheath is advanced into the subcutaneous tissue path during subcutaneous tissue dissection.

49. The method of claim 47, further comprising delivering the one or more electrodes into the subcutaneous tissue path via the sheath.

50. The method of claim 36, wherein delivering the fluid comprises dispensing the fluid from a single ultrasonic dissection tool location or from multiple dissection tool locations.

51. The method of claim 36, wherein the ultrasonic transducer is driven at a power level ranging between about 1 watt and about 200 watts.

52. The method of claim 36, wherein the dissection is performed only in a subcutaneous tissue plane.

53. The method of claim 36, wherein a plane of dissection follows a curvature of the rib cage.

54. The method of claim 36, further comprising ultrasonically disrupting tissue or other debris in the path of the dissection tool as the dissection tool is advanced through the subcutaneous tissue.

55. The method of claim 36, further comprising ultrasonically disrupting dissected tissue or other debris in the fluid delivery system as the dissection tool is advanced through the subcutaneous tissue.

56. The method of claim 36, wherein delivering the fluid comprises delivering an irrigation fluid.

57. The method of claim 36, wherein delivering the fluid comprises delivering a pharmacological agent.

58. The method of claim 36, wherein delivering the fluid comprises delivering an analgesic or an anesthetic.

59. The method of claim 36, wherein delivering the fluid comprises delivering an antibiotic or an antiseptic.

60. A dissection tool, comprising:

an ultrasonic transducer;

means, coupled to the ultrasonic transducer, for dissecting subcutaneous tissue; and

means for delivering a fluid through or along the dissecting means and to tissue subject to dissection.

61. The dissection tool of claim 60, further comprising means for controllably supplying the fluid to the fluid delivering means.

62. The dissection tool of claim 60, further comprising means for aspirating debris from the dissected tissue.

63. The dissection tool of claim 60, further comprising means for controllably activating the ultrasonic transducer.

64. The dissection tool of claim 60, further comprising means for impelling the fluid from the dissecting means and into the tissue subject to dissection.

65. The dissection tool of claim 60, further comprising means for dispensing the fluid from the dissecting means and into the tissue subject to dissection.

66. A dissection system, comprising:

a pump;

a fluid reservoir adapted to provide a fluid to the pump;

a tube; and

a dissection tool comprising an elongated dissecting member, an ultrasonic transducer coupled to the elongated dissecting member, and a fluid channel system extending between proximal and distal ends of the elongated dissecting member, wherein the tube fluidly connects the dissection tool with the pump.

67. The dissection system of claim 66, wherein the ultrasonic transducer is driven by a signal at one or more frequencies ranging between about 20 kilohertz and about 200 kilohertz.

68. The dissection system of claim 66, wherein the ultrasonic transducer is driven by a signal at one or more frequencies of less than about 50 kilohertz.

69. The dissection system of claim 66, wherein the ultrasonic transducer is driven by a signal at one or more frequencies ranging between about 0.2 megahertz and about 3 megahertz.

70. The dissection system of claim 66, wherein the ultrasonic transducer is driven by a pulsed electrical signal having a duty cycle ranging between about 10% and 100%.

71. The dissection system of claim 66, wherein the ultrasonic transducer is driven at a power level ranging between about 1 watt and about 200 watts.

72. The dissection system of claim 66, wherein the fluid channel system comprises a port system, the port system comprising a plurality of apertures.

73. The dissection system of claim 66, wherein the pump comprises a pump controller actuatable by a clinician that controls dispensing of the fluid from the fluid reservoir to the dissection tool.

74. The dissection system of claim 66, further comprising a sheath removably displaceable over the elongated dissecting member.

75. The dissection system of claim 66, wherein the fluid comprises an irrigation fluid.

76. The dissection system of claim 66, wherein the fluid comprises a pharmacological agent.

77. The dissection system of claim 66, wherein the fluid comprises an analgesic or an anesthetic.

78. The dissection system of claim 66, wherein the fluid comprises an antibiotic or an antiseptic.

79. A method of dissecting subcutaneous tissue, comprising:

ultrasonically dissecting subcutaneous tissue to create a path in the subcutaneous tissue;

delivering a fluid to the subcutaneous tissue during subcutaneous tissue dissection; and

impelling the fluid into the subcutaneous tissue via sonophoresis.

80. The method of claim 79, wherein the fluid comprises an irrigation fluid.

81. The method of claim 79, wherein the fluid comprises a pharmacological agent.

82. A method of dissecting subcutaneous tissue, comprising:

ultrasonically dissecting subcutaneous tissue to create a path in the subcutaneous tissue; and

delivering a pharmacological fluid to the subcutaneous tissue during subcutaneous tissue dissection.

83. The method of claim 82, wherein the pharmacological fluid comprises an analgesic or an anesthetic.

84. The method of claim 82, wherein the pharmacological fluid comprises an antibiotic or an antiseptic.