Cardiac treatment devices and methods

• US 7,226,448 B2
• Filed: 04/08/2003
• Issued: 06/05/2007
• Est. Priority Date: 12/04/2001
• Status: Expired due to Term

• Current Assignee: Atricure, Inc.
• Original Assignee: Estech Incorporated
• Inventors: Bertolero, Arthur A., Ibrahim, Tamer, Conley, Daniel J.
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US10/410,618
• Publication Number:
  US 20040102771A1
• Time in Patent Office: 1,519 Days
• Field of Search: 606 41- 50, 607/101, 607/102, 607/116, 607/122, 128/898, 600/374, 604104-108, 604115-116
• US Class Current: 606/41
• CPC Class Codes: A61B 1/12 with cooling or rinsing arrangements
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• CPC Class Codes: A61B 18/1442 Probes having pivoting end effectors, e.g. forceps
• CPC Class Codes: A61B 18/1445 at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 2017/00243 cardiac
• 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 2017/2945 Curved jaws
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00345 Vascular system
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00363 Epicardium
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/126 : bipolar
• CPC Class Codes: A61B 2018/1432 : curved

Abstract

Devices and methods provide for ablation of cardiac tissue for treating cardiac arrhythmias such as atrial fibrillation. Although the devices and methods are often be used to ablate epicardial tissue in the vicinity of at least one pulmonary vein, various embodiments may be used to ablate other cardiac tissues in other locations on a heart. Devices generally include at least one tissue contacting member for contacting epicardial tissue and securing the ablation device to the epicardial tissue, and at least one ablation member for ablating the tissue. Various embodiments include features, such as suction apertures, which enable the device to attach to the epicardial surface with sufficient strength to allow the tissue to be stabilized via the device. For example, some embodiments may be used to stabilize a beating heart to enable a beating heart ablation procedure. Many of the devices may be introduced into a patient via minimally invasive introducer devices and the like. Although devices and methods of the invention may be used to ablate epicardial tissue to treat atrial fibrillation, they may also be used in veterinary or research contexts, to treat various heart conditions other than atrial fibrillation and/or to ablate cardiac tissue other than the epicardium.

Claims

1. A system for treating heart tissue to treat a cardiac arrhythmia, the system comprising:

at least one energy transmission member for applying energy to the heart tissue in a pattern to treat the cardiac arrhythmia;

at least one tissue securing member coupled with the at least one energy transmission member for enhancing contact of the energy transmission member with the heart tissue;

at least one guiding member coupled with at least one of the energy transmission member or the tissue securing member for guiding the energy transmission member and the tissue securing member to a location for treating the heart tissue;

a connector for removably coupling the at least one tissue securing member with the at least one energy transmission member; and

at least one positioning device for contacting the heart tissue and positioning the heart tissue for treatment, the at least one positioning device comprising a suction positioning device;

wherein the at least one tissue securing member is conformable to a surface topography of the heart tissue.

2. A system as in claim 1, further comprising at least one visualization member for enhancing visualization of the heart tissue and the treatment location.

3. A system as in claim 2, wherein the at least one visualization member comprises at least one of an optic imaging device, a thermal imaging device, an ultrasound device, an electrical imaging device or a Doppler imaging device.

4. A system as in claim 3, wherein the optic imaging device comprises a fiber optic device positionable to view a posterior portion of the heart tissue.

5. A system as in claim 3, wherein the thermal imaging device measures at least one heat transfer coefficient of the heart tissue to determine at least one of a type or a thickness of the heart tissue.

6. A system as in claim 3, wherein the electrical imaging device measures at least one of electrical resistance or impedance of the heart tissue to determine at least one of a type and a thickness of the heart tissue.

7. A system as in claim 2, wherein the at least one visualization member is removably coupled with at least one of the at least one energy transmission member, the at least one tissue securing member or the at least one guiding member.

8. A system as in claim 2, wherein the at least one visualization member comprises at least one optic member for acquiring optic signals of an area to be visualized, and wherein the visualization member includes at least one inflatable member coupled with the visualization member at or near the optic member.

9. A system as in claim 8, wherein the at least one inflatable member provides a space in a body cavity to enhance operation of the optic member.

10. A system as in claim 8, wherein the at least one inflatable member provides a space between at least two body tissues to enhance operation of the optic member.

11. A system as in claim 8, wherein the at least one inflatable member comprises an inflation port in fluid communication with an inflation lumen coupled with the visualization member for allowing introduction of a liquid or a gas to inflate the inflatable member.

12. A system as in claim 8, wherein the at least one inflatable member reduces motion of the heart tissue when applied to the heart tissue.

13. A system as in claim 1, wherein the at least one positioning device reduces motion of a beating heart to further position the heart tissue for treatment.

14. A system as in claim 1, wherein the at least one energy transmission member contacts an epicardial surface of the heart tissue to transmit the energy, and wherein the energy is transmitted from the epicardial surface through the heart tissue to an endocardial surface.

15. A system as in claim 14, wherein the energy is further transmitted through at least one of fat and connective tissue covering at least part of the epicardial surface.

16. A system as in claim 1, wherein at least one energy transmission member is coupled with at least one guiding member such that a change in shape of the guiding member causes a corresponding change in shape of the energy transmission member.

17. A system as in claim 16, wherein the guiding member comprises a deformable linear member its shape being adjustable by a user, and wherein the energy transmission member comprises a deformable linear member coaxially coupled with the guiding member so as to move with the guiding member.

18. A system as in claim 17, wherein the guiding member is adjustable to at least partially encircle at least one pulmonary vein.

19. A system as in claim 1, wherein a first longitudinal axis of the tissue securing member and a second longitudinal axis of the removably coupled energy transmission member are parallel to one another.

20. A system as in claim 1, wherein a first longitudinal axis of the tissue securing member and a second longitudinal axis of the removably coupled energy transmission member are offset from one another.

21. A system as in claim 1, wherein the at least one energy transmission member comprises a linear member, and wherein the at least one connector comprises a plurality of connectors disposed along a length of the tissue securing member for removably coupling the linear member with the tissue securing member.

22. A system as in claim 1, wherein the at least one tissue securing member allows compressive force to be applied between the at least one energy transmission member and the heart tissue.

23. A system as in claim 1, wherein the at least one tissue securing member comprises at least one expansible balloon member.

24. A system as in claim 23, wherein the at least one expansible balloon member comprises at least one fluid introduction port for allowing introduction of a liquid or a gas to expand the balloon member.

25. A system as in claim 24, wherein the at least one expansible balloon member comprises multiple, separate balloon members, and wherein each separate balloon member is in fluid communication with a separate fluid introduction port.

26. A system as in claim 25, further comprising means for selectively introducing fluid into one or more of the separate balloons without introducing fluid into one or more other separate balloons.

27. A system as in claim 1, wherein the tissue securing member prevents a portion of the heart tissue from being treated by the at least one energy transmission member.

28. A system as in claim 27, wherein the tissue securing member comprises at least one insulation material for preventing the portion of the heart tissue from being treated.

29. A system as in claim 28, wherein the at least one insulation material further prevents the at least one energy transmission member from contacting or harming other, non-cardiac tissue of the patient and from contacting or harming a user of the energy transmission member.

30. A system as in claim 1, wherein the at least one guiding member comprises at least one of an elongate shaft, a steerable guidewire and an introducer sheath.

31. A system as in claim 30, wherein the steerable guidewire comprises a pushable guidewire having at least one relatively stiff portion and one relatively flexible portion for positioning the energy transmission member in a location for treatment.

32. A system as in claim 30, wherein the steerable guidewire comprises a pullable guidewire to which tension is applied to steer the guidewire to position the energy transmission member in a location for treatment.

33. A system for treating heart tissue to treat a cardiac arrhythmia, the system comprising:

at least one energy transmission member for applying energy to the heart tissue in a pattern to treat the cardiac arrhythmia;

at least one tissue securing member coupled with the at least one energy transmission member for enhancing contact of the energy transmission member with the heart tissue;

at least one needle coupled with the energy transmission member for insertion into the heart tissue to enhance the application of energy to the heart tissue;

at least one guiding member coupled with at least one of the energy transmission member or the tissue securing member for guiding the energy transmission member and the tissue securing member to a location for treating the heart tissue; and

a connector for removably coupling the at least one tissue securing member with the at least one energy transmission member;

wherein the applied energy is selected from the group consisting of radio frequency energy, ultrasound energy, microwave energy, cryogenic energy, thermoelectric energy and laser energy.

34. A system as in claim 33, further comprising at least one grounding device for dispersing the energy from a patient undergoing an energy transmission heart procedure.

35. A system as in claim 33, wherein the energy is transmitted from a tip of each of the at least one needle.

36. A system as in claim 33, wherein the at least one needle is retractable.

37. A system as in claim 36, wherein the at least one retractable needle is exposed and retracted via a pneumatic member coupled with the energy transmission member.

38. A system as in claim 36, wherein the at least one retractable needle is exposed and retracted automatically when the energy transmission member contacts the heart tissue.

39. A system as in claim 36, wherein a depth of penetration of the at least one retractable needle into the heart tissue is adjustable.

40. A system as in claim 33, further comprising at least one closed circuit feedback loop for measuring and regulating operation of the energy transmission member.

41. A system as in claim 33, wherein at least one of the energy transmission member or the tissue securing member further comprises at least one fluid aperture for applying fluid to the heart tissue to enhance the application of energy to the heart tissue.

42. A system for treating heart tissue to treat a cardiac arrhythmia, the system comprising:

at least one energy transmission member for applying energy to the heart tissue in a pattern to treat the cardiac arrhythmia;

at least one tissue securing member coupled with the at least one energy transmission member for enhancing contact of the energy transmission member with the heart tissue;

at least one guiding member coupled with at least one of the energy transmission member or the tissue securing member for guiding the energy transmission member and the tissue securing member to a location for treating the heart tissue; and

a connector for removably coupling the at least one tissue securing member with the at least one energy transmission member;

wherein a first longitudinal axis of the tissue securing member and a second longitudinal axis of the removably coupled energy transmission member are colinear.

43. A system for treating heart tissue to treat a cardiac arrhythmia, the system comprising:

at least one energy transmission member for applying energy to the heart tissue in a pattern to treat the cardiac arrhythmia;

at least one tissue securing member coupled with the at least one energy transmission member for enhancing contact of the energy transmission member with the heart tissue;

at least one guiding member coupled with at least one of the energy transmission member or the tissue securing member for guiding the energy transmission member and the tissue securing member to a location for treating the heart tissue; and

a connector for removably coupling the at least one tissue securing member with the at least one energy transmission member;

wherein the at least one tissue securing member comprises at least one vacuum applying member.

44. A system as in claim 43, wherein the at least one vacuum applying member comprises:

at least one vacuum lumen;

at least one vacuum port in fluid communication with the lumen for coupling the lumen with a vacuum source; and

at least one aperture in fluid communication with the lumen for applying vacuum force to the heart tissue.

45. A system as in claim 44, wherein the at least one vacuum lumen comprises multiple, separate lumens, and wherein each separate lumen is in fluid communication with a separate vacuum port.

46. A system as in claim 45, further comprising means for selectively applying vacuum to one or more of the separate lumens without applying vacuum to one or more other separate lumens.

47. A system for treating heart tissue to treat a cardiac arrhythmia, the system comprising:

at least one therapeutic agent transmission member for applying at least one therapeutic agent to the heart tissue in a pattern to treat the cardiac arrhythmia;

at least one tissue securing member coupled with the at least one therapeutic agent transmission member for enhancing contact of the at least one therapeutic agent transmission member with the heart tissue;

at least one guiding member coupled with at least one of the therapeutic agent transmission member or the tissue securing member for guiding the therapeutic agent transmission member and the tissue securing member to a location for treating the heart tissue;

a first sheath for receiving the at least one guiding member through a first incision; and

a second sheath for receiving at least one of the therapeutic agent transmission member or the tissue securing member through a second incision.

48. A system as in claim 47, wherein the therapeutic agent transmission member comprises:

at least one lumen; and

at least one aperture in the lumen for allowing passage of the at least one therapeutic agent out of the lumen to contact the heart tissue.

49. A system as in claim 48, further comprising at least one needle coupled with the therapeutic agent transmission member for insertion into the heart tissue to enhance application of the at least one therapeutic agent to the heart tissue.

50. A system as in claim 47, wherein the therapeutic agent transmission member comprises:

at least one needle; and

at least one aperture adjacent a tip of each needle for allowing passage of the at least one therapeutic agent out of the needle to contact the heart tissue.

51. A system as in claim 50, wherein the at least one needle is retractable.

52. A system as in claim 51, wherein the at least one retractable needle is exposed and retracted via a pneumatic member coupled with the therapeutic agent transmission member.

53. A system as in claim 51, wherein the at least one retractable needle is exposed and retracted automatically when the therapeutic agent transmission member contacts the heart tissue.

54. A system as in claim 51, wherein a depth of penetration of the at least one retractable needle into the heart tissue is adjustable.

55. A method for treating heart tissue of a patient to treat a cardiac arrhythmia, the method comprising:

advancing at least one treatment member coupled with at least one tissue securing member through a first incision on the patient;

inserting at least one guiding member through a second incision on the patient and securing the at least one guiding member with at least one of the treatment member and the tissue securing member;

visualizing a treatment area in the patient with at least one visualization member;

contacting the heart tissue of the patient with the at least one treatment member and the at least one tissue securing member by manipulating the at least one guiding member;

applying a force, through at least one of the tissue securing member or the guiding member, to enhance contact of the at least one treatment member with the heart tissue; and

treating the heart tissue, using the at least one treatment member.

56. A method as in claim 55, wherein at least one of the treatment member or the tissue securing member are advanced through a port applied to the patient, the port having a diameter no greater than 5 cm.

57. A method as in claim 55, wherein the advancing step includes guiding at least one of the treatment member or the tissue securing member using at least one guiding member.

58. A method as in claim 57, wherein guiding comprises using a pushable guidewire having at least one relatively stiff portion and one relatively flexible portion for positioning the treatment member in a location for treatment.

59. A method as in claim 57, wherein guiding comprises using a pullable guidewire to which tension is applied to steer the guidewire to position the treatment member in a location for treatment.

60. A method as in claim 55, further comprising using at least one positioning device to position the heart tissue for treatment.

61. A method as in claim 60, wherein using the at least one positioning device comprises applying suction to the heart tissue.

62. A method as in claim 60, wherein using the at least one positioning device reduces motion of the heart tissue.

63. A method as in claim 55, wherein contacting the heart tissue comprises applying a suction force with the tissue securing member to increase a contact surface area of the tissue securing member with the heart tissue.

64. A method as in claim 63, wherein applying the suction force further comprises providing consistent contact force between the heart tissue and the tissue securing member.

65. A method as in claim 63, wherein applying the suction force comprises securing the tissue securing member and the treatment member to the heart tissue, the tissue securing member and the treatment member having the same cross-sectional shape.

66. A method as in claim 55, wherein treating the heart tissue comprises applying energy to the heart tissue in a pattern to reduce or eliminate the cardiac arrhythmia.

67. A method as in claim 66, wherein applying the energy comprises applying at least one of radio frequency energy, ultrasound energy, microwave energy, cryogenic energy, thermoelectric energy or laser energy.

68. A method as in claim 66, wherein applying the energy comprises applying energy to an epicardial surface of the heart, and wherein the energy is transmitted from the epicardial surface through the heart tissue to an endocardial surface.

69. A method as in claim 68, wherein the energy is further transmitted through at least one of fat and connective tissue covering at least part of the epicardial surface.

70. A method as in claim 66, further comprising dispersing the energy from the patient through at least one grounding device coupled with the patient.

71. A method as in claim 66, further comprising inserting at least one needle into the heart tissue to enhance the application of energy to the heart tissue.

72. A method as in claim 71, wherein the energy is transmitted from a tip of each of the at least one needle.

73. A method as in claim 71, further comprising extending the at least one needle from a retracted position before applying the energy and retracting the at least one needle to the retracted position when the energy has been applied.

74. A method as in claim 73, further comprising selecting a depth of penetration of the at least one retractable needle into the heart tissue.

75. A method as in claim 66, further comprising:

measuring the application of energy to the heart tissue using at least one closed circuit feedback loop; and

regulating the application of energy to the heart tissue based on the measurement.

76. A method as in claim 66, further comprising applying fluid to the heart tissue to enhance the application of energy to the heart tissue.

77. A method as in claim 55, wherein treating the heart tissue comprises applying at least one therapeutic agent to the heart tissue in a pattern to reduce or eliminate the cardiac arrhythmia.

78. A method as in claim 77, wherein applying the at least one therapeutic agent comprises infusing the agent through at least one aperture in the at least one treatment member.

79. A method as in claim 78, applying the at least one therapeutic agent comprises infusing the agent through at least one aperture in at least one needle coupled with the treatment member.

80. A method as in claim 77, wherein applying the at least one therapeutic agent comprises:

inserting at least one needle into the heart tissue to a desired depth;

injecting the at least one agent into the heart tissue; and

removing the at least one needle from the heart tissue.

81. A method as in claim 80, further comprising:

extending the at least one needle from a retracted position for insertion into the heart tissue; and

retracting the at least one needle to the retracted position after injection.

82. A method as in claim 55, further including adjusting a shape of a guiding member coupled with the at least one treatment member to alter the shape of the treatment member.

83. A method as in claim 82, wherein adjusting the shape of the guiding member allows the treatment member to conform to a surface of the heart tissue.

84. A method as in claim 82, wherein adjusting the shape of the guiding member allows the treatment member to at least partially encircle at least one pulmonary vein.

85. A method as in claim 55, further comprising removably coupling the tissue securing member with the at least one treatment member.

86. A method as in claim 85, further comprising conforming the tissue securing member to a surface topography of the heart tissue.

87. A method as in claim 55, wherein applying force comprises applying compressive force between the at least one treatment member and the heart tissue.

88. A method as in claim 87, wherein applying the compressive force comprises applying vacuum force via at least one vacuum member of the tissue securing member.

89. A method as in claim 88, further comprising applying the vacuum force through at least a portion of the vacuum member while not applying the vacuum force through at least another portion of the vacuum member.

90. A method as in claim 87, wherein applying the compressive force comprises applying force via at least one expansible balloon member.

91. A method as in claim 87, further comprising preventing, using the tissue securing member, a portion of the heart tissue from being treated by the at least one treatment member.

92. A method as in claim 91, wherein the tissue securing member comprises at least one insulation material for preventing the portion of the heart tissue from being treated.

93. A method as in claim 55, visualizing comprises using at least one visualization member selected from the group consisting of an optic imaging device, a thermal imaging device, an ultrasound device, an electrical imaging device and a Doppler imaging device.

94. A method as in claim 93, further comprising expanding an expansible balloon coupled with the visualization member near an optic element to enhance visualization.

95. A method as in claim 94, wherein expanding the balloon provides a space in a body cavity to enhance operation of the optic member.

96. A method as in claim 94, wherein expanding the balloon provides a space between at least two body tissues to enhance operation of the optic member.

97. A method as in claim 94, wherein expanding the balloon reduces motion of the heart tissue when applied to the heart tissue.

101. A method as in claim 55, wherein the at least one treatment member and the at least one tissue securing member are advanced through the first incision via a first sheath applied to the patient, and wherein the at least one guiding member is advanced through the second incision via a second sheath applied to the patient.

98. A method for treating heart tissue of a patient to treat a cardiac arrhythmia, the method comprising:

advancing at least one treatment member and at least one tissue securing member through an incision on the patient;

removably coupling the at least one treatment member with the at least one tissue securing member;

visualizing a treatment area in the patient with at least one visualization member;

contacting the heart tissue of the patient with the treatment member and the tissue securing member;

applying a force, through the tissue securing member, to enhance contact of the treatment member with the heart tissue; and

treating the heart tissue, using the at least one treatment member.

99. A method as in claim 98, wherein the treatment member is advanced through the tissue securing member.

100. A method as in claim 98, wherein the treatment member and the tissue securing member are advanced through a minimally invasive port applied to the patient.