Resistive heating system and apparatus for improving blood flow in the heart

• US 6,176,856 B1
• Filed: 12/18/1998
• Issued: 01/23/2001
• Est. Priority Date: 12/18/1998
• Status: Expired due to Fees

• Current Assignee: Eclipse Surgical Technologies, Inc. (Cryolife Incorporated)
• Original Assignee: Eclipse Surgical Technologies, Inc. (Cryolife Incorporated)
• Inventors: Khairkhahan, Alexander, Jandak, Jennifer, Rosinko, Michael J., Horzewski, Michael J.
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/215,110
• Time in Patent Office: 767 Days
• Field of Search: 606/41, 606/42, 606/45, 606/46, 606/47-50, 607/101, 607/102, 607/98
• US Class Current: 606/29
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation

Abstract

A catheter system with an outer catheter body defining at least one lumen and an inner catheter body defining at least one lumen with proximal and distal portions. An introducer is coupled to the distal portion of the inner catheter body. The introducer has a tissue piercing distal end. A resistive heater element is positioned in the introducer. The outer catheter is introduced into a patient'"'"'s vasculature. The inner catheter is then introduced through the lumen of the outer catheter to a selected heart site. The tissue piercing distal end of the introducer is then advanced into an interior of the heart at the selected heart site. Energy is delivered to the selected heart site from the resistive heater element to create a blood conducting pathway and/or stimulate angiogenesis. In an alternative embodiment, a heart treatment apparatus includes a handpiece with a proximal and a distal end and an elongated member defining at least one lumen coupled to the handpiece distal end. The elongated member has a distal end and an introducer coupled to the distal end. The introducer has a tissue piercing distal end. A resistive heater element is positioned in the introducer. The tissue piercing distal end is introduced through a port in the chest wall into a chest cavity and through an epicardial surface of the heart wall to a selected site within the heart. Energy is delivered to the selected heart site from the resistive heater element to create a blood conducting pathway and/or stimulate angiogenesis.

Claims

1. A catheter system comprising:

an outer catheter with an outer catheter distal portion, including an elongated outer catheter body defining at least one outer catheter lumen;

an inner catheter configured to be advanceable within an outer catheter lumen, the inner catheter, including an elongated inner catheter body having a proximal portion and a distal portion, the elongated inner catheter body defining at least one inner catheter lumen;

an introducer coupled to the distal portion of the elongated inner catheter body, the introducer including a tissue piercing distal end and defining a lumen; and

a resistive heater element positioned within the lumen of the introducer.

2. The catheter system of claim 1, further comprising a protective sheath layer positioned in the outer catheter distal portion, the sheath layer being configured to prevent a puncture of the outer catheter by the introducer.

3. The catheter system of claim 1, wherein the elongated inner catheter body is deflectable.

4. The catheter system of claim 3, wherein the introducer is less deflectable than the elongated inner catheter body.

5. The catheter system of claim 3, wherein the introducer is substantially non-deflectable.

6. The catheter system of claim 1, wherein a resistive heater element distal end is positioned in the distal portion of the elongated inner catheter body.

7. The catheter system of claim 1, further comprising:

an advancement member coupled to the elongated inner catheter body to advance at least a portion of the introducer into a selected tissue site.

8. The catheter system of claim 7, further comprising:

a stop coupled to the advancement member, the stop preventing a further advancement of the introducer through the selected tissue site.

9. The catheter system of claim 1, further comprising:

an introducer tip alignment mechanism coupled to the elongated inner catheter body, wherein the introducer tip is maintained equidistant from the distal end of the outer catheter during deflection.

10. The catheter system of claim 1, further comprising:

a thermal sensor coupled to the introducer.

11. The catheter system of claim 10, further comprising:

a controller coupled to the thermal sensor.

12. The catheter system of claim 1, further comprising:

a contact sensor coupled to the introducer.

13. The catheter system of claim 12, further comprising:

a controller coupled to the contact sensor.

14. The catheter system of claim 1, further comprising:

a column strength member positioned in at least a portion of the introducer.

15. The catheter system of claim 1, further comprising:

a tissue adherence reduction layer positioned at an exterior of the introducer.

16. The catheter system of claim 1, further comprising:

a coupling member coupling the introducer to the elongated inner catheter body.

17. The catheter system of claim 16, wherein the coupling member is configured to reduce kinking of the introducer as the introducer is advanced through a vasculature into a heart tissue.

18. The catheter system of claim 1, wherein the tissue piercing distal end of the introducer has a beveled point.

19. The catheter system of claim 1, wherein the tissue piercing distal end of the introducer has a trocar point.

20. The catheter system of claim 1, wherein the introducer has a length no greater than 10 mm.

21. The catheter system of claim 1, further comprising:

a radio-opaque marker coupled to the introducer.

22. The catheter system of claim 1, further comprising an adaptor fluidically coupled to the outer catheter.

23. The catheter system of claim 22 wherein said adaptor is configured to be coupled to a tubular connector.

24. The catheter system of claim 22 wherein said adaptor is configured to be coupled to a Luer connector.

25. The catheter system of claim 1, further comprising:

a drug delivery device coupled to the outer catheter.

26. The catheter system of claim 25, further comprising one or more medicaments coupled to the drug delivery device.

27. The catheter system of claim 26, wherein the one or more medicaments are disposed in a drug delivery reservoir coupled to the drug delivery device.

28. A heart treatment apparatus comprising:

a handpiece with a proximal end and a distal end;

an elongated member with a proximal portion and a distal portion, the elongated member defining at least one lumen, the elongated member proximal portion coupled to the handpiece distal end;

an introducer with a tissue piercing distal end, the introducer coupled to the distal portion of the elongated member and defining a lumen; and

a resistive heater element positioned within the lumen of the introducer.

29. The apparatus of claim 28, wherein the introducer includes a column strength member positioned in at least a portion of the introducer.

30. The apparatus of claim 28, wherein the elongated member is deflectable.

31. The apparatus of claim 30, wherein the introducer is less deflectable than the elongated member.

32. The apparatus of claim 30, wherein the introducer is substantially non-deflectable.

33. The apparatus of claim 28, wherein a resistive heater element distal end is positioned in the distal portion of the elongated member.

34. The apparatus of claim 28, further comprising:

a thermal sensor coupled to the introducer.

35. The apparatus of claim 34, further comprising:

a controller coupled to the thermal sensor.

36. The apparatus of claim 28, further comprising:

a contact sensor coupled to the introducer.

37. The apparatus of claim 36, further comprising:

a controller coupled to the contact sensor.

38. The apparatus of claim 28, further comprising:

a tissue adherence reduction coating applied to an exterior of the introducer.

39. The apparatus of claim 28, wherein the tissue piercing distal end of the introducer has a beveled point.

40. The apparatus of claim 28, wherein the tissue piercing distal end of the introducer has a trocar point.

41. The apparatus of claim 28, wherein the introducer has a length no greater than 10 mm.

42. The apparatus of claim 28, further comprising:

a radio-opaque marker coupled to the introducer.

43. The apparatus of claim 28, further comprising an advancement mechanism including a solenoid, a depth stop, a spring, an introducer flange and the introducer, the advancement mechanism configured to controllably advance the introducer a fixed penetration depth into a heart from an epicardial surface.

44. The apparatus of claim 28, further comprising an adaptor fluidically coupled to the elongated member.

45. The apparatus of claim 44, wherein said adaptor is configured to be coupled to a tubular connector.

46. The apparatus of claim 44, wherein said adaptor is configured to be coupled to a Luer connector.

47. The heart treatment apparatus of claim 28, further comprising:

an introducer tip alignment mechanism coupled to the elongated member, wherein the introducer tip is maintained equidistant from the distal end of the outer catheter during deflection.

48. The heart treatment apparatus of claim 28, further comprising:

a drug delivery device coupled to the elongated member.

49. The heart treatment apparatus of claim 48, further comprising:

one or more medicaments coupled to the drug delivery device.

50. The heart treatment apparatus of claim 49, wherein the one or more medicaments are disposed in a drug delivery reservoir coupled to the drug delivery device.

51. A heart treatment system comprising:

a handpiece with a proximal end and a distal end;

an outer elongated member with an outer elongated member proximal portion and an outer elongated member distal portion, the outer elongated member defining at least one outer elongated member lumen, the outer elongated member proximal portion coupled to the handpiece distal end;

an inner catheter configured to be advanceable within the outer elongated member lumen, the inner catheter including an elongated inner catheter body having a proximal portion and a distal portion, the elongated inner catheter body defining at least one inner catheter lumen;

an introducer coupled to the distal portion of the elongated inner catheter body, the introducer including a tissue piercing distal end and defining a lumen; and

a resistive heater element positioned within the lumen of the introducer.

52. The heart treatment system of claim 51, further comprising:

a protective sheath layer positioned in at least a portion of the outer elongated member, the sheath layer being configured to prevent a puncture of the outer elongated member by the introducer.

53. The heart treatment system of claim 51, wherein the elongated inner catheter body is deflectable.

54. The heart treatment system of claim 53, wherein the introducer is less deflectable than the elongated inner catheter body.

55. The heart treatment system of claim 53, wherein the introducer is substantially non-deflectable.

56. The heart treatment system of claim 51, wherein a resistive heater element distal end is positioned in the distal portion of the elongated inner catheter body.

57. The heart treatment system of claim 51, further comprising:

an advancement member coupled to the elongated inner catheter body to advance at least a portion of the introducer into a selected tissue site.

58. The heart treatment system of claim 57, further comprising:

a stop coupled to the advancement member, the stop preventing a further advancement of the introducer through the selected tissue site.

59. The heart treatment system of claim 51, further comprising:

an introducer tip alignment mechanism coupled to the elongated inner catheter body, wherein the introducer tip is maintained equidistant from the distal end of the outer catheter during deflection.

60. The heart treatment system of claim 51, further comprising:

a thermal sensor coupled to the introducer.

61. The heart treatment system of claim 60, further comprising:

a controller coupled to the thermal sensor.

62. The heart treatment system of claim 51, further comprising:

a contact sensor coupled to the introducer.

63. The heart treatment system of claim 62, further comprising:

a controller coupled to the contact sensor.

64. The heart treatment system of claim 51, further comprising:

a column strength member positioned in at least a portion of the introducer.

65. The heart treatment system of claim 51, further comprising:

a tissue adherence reduction layer positioned at an exterior of the introducer.

66. The heart treatment system of claim 51, further comprising:

a coupling member coupling the introducer to the elongated inner catheter body.

67. The heart treatment system of claim 51, wherein the tissue piercing distal end of the introducer has a beveled point.

68. The heart treatment system of claim 51, wherein the tissue piercing distal end of the introducer has a trocar point.

69. The heart treatment system of claim 51, wherein the introducer has a length no greater than 10 mm.

70. The heart treatment system of claim 51, further comprising:

a radio-opaque marker coupled to the introducer.

71. The heart treatment system of claim 51, further comprising an adaptor fluidically coupled to the outer elongated member.

72. The heart treatment system of claim 71 wherein said adaptor is configured to be coupled to a tubular connector.

73. The heart treatment system of claim 71 wherein said adaptor is configured to be coupled to a Luer connector.

74. The heart treatment system of claim 51, further comprising:

a drug delivery device coupled to the outer elongated member.

75. The heart treatment system of claim 74, further comprising one or more medicaments coupled to the drug delivery device.

76. The heart treatment system of claim 75, wherein the one or more medicaments are disposed in a drug delivery reservoir coupled to the drug delivery device.

77. A catheter system comprising:

an outer catheter with an outer catheter distal portion, including an elongated outer catheter body defining at least one outer catheter lumen;

an inner catheter configured to be advanceable within an outer catheter lumen, the inner catheter, including an elongated inner catheter body having a proximal portion and a distal portion, the elongated inner catheter body defining at least one inner catheter lumen;

an introducer coupled to the distal portion of the elongated inner catheter body, the introducer including a tissue piercing distal end and defining a lumen; and

an energy delivery device coupled to an energy source, the energy delivery device positioned within the lumen of the introducer, wherein the energy delivery device indirectly heats the introducer.

78. The catheter system of claim 77 wherein the energy delivery device is a radio-frequency electrode and the power source is an RF source.

79. The catheter system of claim 77 wherein the energy delivery device is an optical fiber and the power source is a coherent light source.

80. The catheter system of claim 77 wherein the energy delivery device is an optical fiber and the power source is a incoherent light source.

81. The catheter system of claim 77 wherein the energy delivery device is a thermally conductive element in fluid connection with the inner catheter lumen and the power source is a heated fluid source.

82. The catheter system of claim 77 wherein the energy delivery device is a microwave antenna and the power source is a microwave source.

83. The catheter system of claim 82 wherein the microwave source provides energy from 915 MHz to 2.45 GHz.

84. The catheter system of claim 77 wherein the energy delivery device is an ultrasound emitter and the power source is an ultrasound power source.

85. The catheter system of claim 84 wherein the ultrasound power source provides energy in the range of 300 KHz to 3 GHZ.

86. The catheter system of claim 77 wherein the energy delivery device is a thermally conductive frictional stationary element frictionally coupled to a moving element and the power source is a driving means for rotationally turning the moving element.

87. A heart treatment apparatus comprising:

a handpiece with a proximal end and a distal end;

an elongated member with a proximal portion and a distal portion, the elongated member defining at least one lumen, the elongated member proximal portion coupled to the handpiece distal end;

an introducer with a tissue piercing distal end, the introducer coupled to the distal portion of the elongated member;

a resistive heater element positioned in the introducer; and

a column strength member positioned in at least a portion of the introducer.

88. The apparatus of claim 87, wherein the column strength member is positioned centrally in the introducer.

89. The apparatus of claim 87, wherein the resistive heater element is in a surrounding relationship to the column strength member.

90. The apparatus of claim 87, wherein the column strength member extends into at least a portion of the elongated member.

91. The apparatus of claim 87, wherein the column strength member has a stiffness that varies in a longitudinal direction.

92. The apparatus of claim 87, wherein the column strength member has a stiffness that can be altered by a change in a temperature of the column strength member.

93. The apparatus of claim 87, wherein the column strength member has a stiffness that can be controlled in vivo.

94. The apparatus of claim 87, further comprising:

a coupling member coupling the introducer to the elongated member.

95. A heart treatment apparatus comprising:

a handpiece with a proximal end and a distal end;

an elongated member with a proximal portion and a distal portion, the elongated member defining at least one lumen, the elongated member proximal portion coupled to the handpiece distal end;

an introducer with a tissue piercing distal end, the introducer coupled to the distal portion of the elongated member;

a resistive heater element positioned in the introducer; and

an advancement mechanism including a solenoid, a depth stop, a spring, an introducer flange and the introducer, the advancement mechanism configured to controllably advance the introducer a fixed penetration depth into a heart from an epicardial surface.

96. The apparatus of claim 95, further comprising a controller coupled to the solenoid.

97. The apparatus of claim 96, further comprising a contact sensor couple to the controller.

98. The apparatus of claim 95, wherein a lateral position of the introducer flange is adjustable.

99. A heart treatment system comprising:

a handpiece with a proximal end and a distal end;

an outer elongated member with an outer elongated member proximal portion and an outer elongated member distal portion, the outer elongated member defining at least one outer elongated member lumen, the outer elongated member proximal portion coupled to the handpiece distal end;

an inner catheter configured to be advanceable within the outer elongated member lumen, the inner catheter including an elongated inner catheter body having a proximal portion and a distal portion, the elongated inner catheter body defining at least one inner catheter lumen;

an introducer coupled to the distal portion of the elongated inner catheter body, the introducer including a tissue piercing distal end;

a resistive heater element positioned in the introducer; and

a column strength member positioned in at least a portion of the introducer.

100. The heart treatment system of claim 99, wherein the column strength member is positioned centrally in the introducer.

101. The heart treatment system of claim 99, wherein the resistive heater element is in a surrounding relationship to the column strength member.

102. The heart treatment system of claim 99, wherein the column strength member has a stiffness that varies in a longitudinal direction.

103. The heart treatment system of claim 99, wherein the column strength member has a stiffness that can be altered by a change in a temperature of the column strength member.

104. The heart treatment system of claim 99, wherein the column strength member has a stiffness that can be controlled in vivo.

105. A catheter system comprising:

an outer catheter with an outer catheter distal portion, including an elongated outer catheter body defining at least one outer catheter lumen;

an inner catheter configured to be advanceable within an outer catheter lumen, the inner catheter, including an elongated inner catheter body having a proximal portion and a distal portion, the elongated inner catheter body defining at least one inner catheter lumen;

an introducer coupled to the distal portion of the elongated inner catheter body, the introducer including a tissue piercing distal end;

a resistive heater element positioned in the introducer; and

a column strength member positioned in at least a portion of the introducer.

106. The catheter system of claim 105, wherein the column strength member is positioned centrally in the introducer.

107. The catheter system of claim 105, wherein the resistive heater element is in a surrounding relationship to the column strength member.

108. The catheter system of claim 105, wherein the column strength member has a stiffness that varies in a longitudinal direction.

109. The catheter system of claim 105, wherein the column strength member has a stiffness that can be altered by a change in a temperature of the column strength member.

110. The catheter system of claim 105, wherein the column strength member has a stiffness that can be controlled in vivo.

111. A heart treatment system comprising:

a handpiece with a proximal end and a distal end;

an outer elongated member with an outer elongated member proximal portion and an outer elongated member distal portion, the outer elongated member defining at least one outer elongated member lumen, the outer elongated member proximal portion coupled to the handpiece distal end;

an inner catheter configured to be advanceable within the outer elongated member lumen, the inner catheter including an elongated inner catheter body having a proximal portion and a distal portion, the elongated inner catheter body defining at least one inner catheter lumen;

an introducer coupled to the distal portion of the elongated inner catheter body, the introducer including a tissue piercing distal end;

a resistive heater element positioned in the introducer; and

a coupling member coupling the introducer to the elongated inner catheter body.

112. The heart treatment system of claim 111, wherein the coupling member is configured to reduce kinking of the introducer as the introducer is advanced through a vasculature into a heart tissue.