Ablation instruments and methods for performing abalation

• US 20060271032A1
• Filed: 05/26/2005
• Published: 11/30/2006
• Est. Priority Date: 05/26/2005
• Status: Abandoned Application

• Current Assignee: Maquet Cardiovascular LLC (Getinge AB)
• Original Assignee: Maquet Cardiovascular LLC (Getinge AB)
• Inventors: Chin, Albert K., Willis, Geoffrey H., Uemura, Shuji, Callas, Peter
• Application Number:
  US11/137,987
• Publication Number:
  US 20060271032A1
• Time in Patent Office: Days
• US Class Current: 606/41
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00375 Ostium, e.g. ostium of pulmonary vein or artery

Abstract

Methods, devices and instruments provided for performing ablation transmurally across the wall of an organ. Devices may directly access tissue to be ablated through direct access openings formed in the patient and, optionally, an organ where the ablation is to be performed. Instruments facilitating making openings, dissecting, and delivery of ablation instruments are also described.

Claims

1. A method of performing ablation transmurally across the wall of an organ, said method comprising the steps of:

preparing an opening in a patient to provide direct access to the wall of the organ;

preparing an opening through the organ;

inserting an ablation device through the opening in the patient and the opening through the organ;

approximating a target area of an inner wall of the organ with an ablation element of the ablation device; and

ablating the target area to create a lesion.

2. The method of claim 1, wherein the lesion is a transmural lesion.

3. The method of claim 1, wherein the organ is a heart.

4. The method of claim 3 wherein the organ is an atrium of the heart.

5. The method of claim 4, wherein the organ is a left atrium of the heart.

6. The method of claim 4, wherein said preparing an opening through the organ comprises creating an incision in the atrial appendage of the atrium.

7. The method of claim 3, wherein the opening is formed through the apex to gain access to the left ventricle.

8. The method of claim 7, wherein the target area is an inner wall of the left ventricle.

9. The method of claim 6, further comprising attaching a delivery guide to the atrial appendage to surround the incision and to provide a guide for insertion of the ablation device therethrough.

10. A method of performing atrial ablation, said method comprising the steps of:

making an opening in a patient to provide direct access to the heart of the patient;

making an opening in the pericardium;

inserting an ablation device through the opening in the patient and the opening in the pericardium;

approximating a target area of a wall of the organ with an ablation element of the ablation device; and

ablating the target area to create a lesion.

11. The method of claim 10, wherein said opening in a patient is a small thoracotomy.

12. The method of claim 10, wherein the heart continues to beat during the performance of all of said steps.

13. The method of claim 10, wherein the lesion is a transmural lesion.

14. The method of claim 10, wherein the target area approximated is on the epicardial wall of the atrium.

15. The method of claim 10, further comprising making an opening in the atrial appendage of the atrium, wherein said inserting an ablation device further comprises inserting the ablation device through the opening of the atrial appendage, and wherein the target area approximated is on the endocardial wall of the atrium.

16. The method of claim 15, wherein the target area includes endocardium around at least one pulmonary ostium.

17. The method of claim 15, further comprising attaching a delivery guide to the atrial appendage to surround the opening therein and to provide a guide for insertion of the ablation device therethrough.

18. The method of claim 17, further comprising applying a purse string suture around the atrial appendage, and tightening the purse string suture during removal of the delivery guide to reduce blood loss from the opening in the atrial appendage.

19. A method of performing atrial ablation, said method comprising the steps of:

inserting an ablation device comprising a rigid or malleable tube and at least one ablation element at a distal end portion thereof through an opening in the chest of a patient and through the atrium;

viewing the location and placement of the distal end of the ablation device through an endoscope passing axially therethrough; and

ablating tissue at a target location on the endocardium in the atrium.

20. The method of claim 19, further comprising monitoring said ablating, and ceasing said ablating when it is determined by said monitoring that a sufficient amount of ablation has been performed.

21. The method of claim 19, wherein the heart continues to beat during the performance of all of said steps.

22. The method of claim 20, wherein said monitoring comprises visual monitoring through the endoscope.

23. The method of claim 20, wherein said monitoring comprises contacting the tissue with at least one thermocouple in at least one location radially inward or outward of said at least one ablation element with respect to the ablation device, by a distance substantially equal to a thickness of a wall of the atrium in the target location.

24. The method of claim 19, wherein the at least one ablation element is placed radially beyond a periphery of a pulmonary ostium, and said ablating is performed to provide a ring-shaped lesion in the endocardium of the atrium surrounding the pulmonary ostium.

25. An ablation device for directly accessing a surgical site to perform ablation on a targeted tissue, said device comprising:

an elongated rigid or malleable tube having a distal end portion and a proximal end portion, said elongated tube having sufficient length so that at least a proximal end of the proximal end portion extends out of a patient when a distal end of the distal end portion contacts the targeted tissue;

an endoscope axially received within said elongated rigid or malleable tube;

a transparent tip closing the distal end of said distal end portion, wherein said transparent tip enables direct viewing through the distal end of the device using said endoscope; and

at least one ablation element mounted on said device at said distal end portion.

26. The ablation device of claim 25, wherein said at least one ablation element is mounted radially outside of a perimeter of said transparent tip.

27. The ablation device of claim 25, wherein said transparent tip is hemispherical.

28. The ablation device of claim 25, wherein said distal end portion has an outside diameter that is larger than an outside diameter of a portion of said tube adjacent said distal end portion, to permit said at least one ablation element to be mounted radially outside of the perimeter of said transparent tip on a distal end of said distal end portion.

29. The ablation device of claim 25, wherein said elongated tube is rigid.

30. The ablation device of claim 25, wherein said at least one ablation element comprises a circumferentially electrically conducting element mounted around a circumference of said distal end of said distal end portion.

31. The ablation device of claim 25, wherein said at least one ablation element comprises an arc-shaped electrically conducting element mounted on a portion of a circumference of said distal end of said distal end portion.

32. The ablation device of claim 25, wherein said at least one ablation element comprises a single point-shaped electrically conducting element mounted on a point location of a circumference of said distal end of said distal end portion.

33. The ablation device of claim 25, wherein said at least one ablation element is mounted inside of said distal end portion and is configured to conduct ablation energy to saline in contact therewith.

34. The ablation device of claim 25, wherein said transparent tip is sized to approximate an inside diameter of an ostium of a pulmonary vein located in a left atrium of a patient.

35. The ablation device of claim 25, wherein at least said distal end portion of said tube is articulatable with respect to said proximal end portion.

36. The ablation device of claim 25, further comprising a light emitter provided in said distal end portion configured to direct light out of the distal end of said device.

37. The ablation device of claim 25, further comprising a sliding ring configured to slide with respect to said tube, over said transparent tip such that at least a distal end of said sliding ring is positioned distally of said transparent tip, wherein said at least one ablation element is mounted on said distal end of said sliding ring.

38. The ablation device of claim 25, further comprising a sliding ring configured to slide with respect to said tube, said device configured to deliver saline into contact with said at least one ablation element, wherein said at least one ablation element is mounted inside of said sliding ring and is configured to conduct ablation energy to saline contacting said at least one ablation element.

39. The ablation device of claim 37, wherein said sliding ring is slidable to a retracted position where said transparent tip extends distally of said distal end of said sliding ring.

40. The ablation device of claim 25, wherein said endoscope is axially translatable with respect to said elongated tube to change a distance of a distal end of said endoscope from the distal end of said distal end portion of said device.

41. The ablation device of claim 25, wherein said transparent tip is formed of an elastomer.

42. The ablation device of claim 41, wherein said transparent tip is inflatable to about 300% to about 500% elongation of the elastomeric balloon material.

43. The ablation device of claim 37, wherein said sliding ring comprises a radially expandable ring, and said transparent tip is formed of an elastomer, said transparent tip being inflatable to expand a circumference thereof, wherein upon inflating said transparent tip to expand the circumference thereof, said expandable ring is also radially expanded.

44. The ablation device of claim 25, further comprising an additional tube coaxially positioned over said elongated rigid or malleable tube, wherein said at least one ablation element is mounted on a distal end portion of said additional tube.

45. The ablation device of claim 44, wherein said distal end portion of said additional tube comprises an expanding member.

46. The ablation device of claim 45, wherein, when in a contracted configuration, said expanding member is substantially tubular, and closely conforms to said additional tube, and when in an expanded configuration, said expanding member is substantially funnel-shaped, with the larger diameter portion of the funnel-shape at the distal end of said expanding member.

47. The ablation device of claim 46, wherein said transparent tip is inflatable, and wherein said expanding member positions said at least one ablation member radially outside of said transparent tip when said transparent tip is inflated and said expanding member is in said expanded configuration.

48. The ablation device of claim 45, wherein said expanding member comprises an expanding frame having eyelets through which said at least one ablation member is threaded.

49. The ablation device of claim 48, wherein said expanding frame has a sinusoidal configuration.

50. The ablation device of claim 45, further comprising a thin sheet of material covering said expanding frame to exclude fluids from passing through said expanding member and into a cavity defined therein.

51. The ablation device of claim 25, further comprising at least one thermocouple mounted at said distal end of said distal end portion in at least one location radially inward or outward of said at least one ablation element by a distance substantially equal to a thickness of a wall of an organ to be transmurally ablated by contact with the targeted tissue.

52. The ablation device of claim 25, wherein said transparent tip comprises a flexible, generally inelastic balloon that, when deflated may is gatherable about said tube to closely conform to a cross-section profile of said tube.

53. The ablation device of claim 52, wherein, when inflated, said transparent tip expands to an inflated configuration, said inflated configuration having an outside diameter substantially larger than an outside diameter of said tube.

54. The ablation device of claim 53, wherein said outside diameter of said transparent tip in said inflated configuration is larger than an inside diameter of a pulmonary vein ostium about which an ablation is to be performed.

55. The ablation device of claim 52, wherein said generally inelastic balloon comprises a generally inelastic polymer selected from the group consisting of:

polyethylene, polyurethane, polyvinyl chloride and polyethylene terepthalate.

56. The ablation device of claim 52, wherein said at least one ablation element is mounted on a distal face of said generally inelastic balloon.

57. The ablation device of claim 56, wherein said at least one ablation element comprises a flexible ablation element.

58. The ablation device of claim 56, wherein said at least one ablation element is adhered to said distal face.

59. The ablation device of claim 53, wherein a distal end portion of said endoscope is positionable inside of said generally inelastic balloon in said inflated configuration such that an outline of said at least one ablation element is visible through said endoscope.

60. The ablation device of claim 25, wherein said at least one ablation element has an encircling configuration dimensioned to surround a pulmonary vein ostium without contacting or intersecting the pulmonary vein ostium.

61. The ablation device of claim 59, wherein said distal end portion of said endoscope is axially slidable with respect to said inelastic balloon.

62. The ablation device of claim 52, further comprising a protrusion extending from a distal face of said generally inelastic balloon.

63. The ablation device of claim 25, wherein said transparent tip is expandable to vary an outside diameter thereof.

64. The ablation device of claim 25, further comprising a mechanism for mechanically increasing or decreasing the outside diameter of said transparent tip.

65. The ablation device of claim 63, wherein said transparent tip comprises a conical lens, said conical lens being mounted to a coil, said coil being manipulatable to vary the outside diameter of said conical lens.

66. The ablation device of claim 65, wherein said coil comprises a first end mounted to said tube, and a second end mounted to a second tube provided coaxially within said tube and coaxially over said endoscope, wherein relative rotation between said tube and said second tube actuates said coil to vary the outside diameter of said conical lens.

67. The ablation device of claim 63, wherein said transparent tip comprises a lens having overlapping edges, wherein rotation of one of said edges with respect to another of said edges varies the outside diameter of said lens.

68. The ablation device of claim 63, further comprising a sealing sleeve extending between said transparent tip and said tube.

69. The ablation device of claim 66, further comprising a control mechanism for selectively maintaining said tube and said second tube in fixed positions relative to one another to maintain a desired outside diameter of said tip.

70. The ablation device of claim 25, wherein said transparent tip comprises an elastic tip member and said at least one ablation element comprises a single point element adapted to contact tissue and be circumscribed about an ablation site by rotation of said tube and said tip.

71. The ablation device of claim 70, wherein said elastic tip member is configured to be inflated to facilitate viewing therethrough and through said endoscope.

72. The ablation device of claim 25, wherein said transparent tip is rigid.

73. The ablation device of claim 72, wherein said at least one ablation element comprises an element adapted to be dragged over tissue to form a lesion pathway that follows the dragging of said element.

74. The ablation device of claim 72, wherein said at least one ablation element comprises a pair of electrodes mounted peripherally of said transparent tip.

75. The ablation device of claim 72, wherein said rigid transparent tip has a blunt shape.

77. The ablation device of claim 25, wherein said at least one ablation element comprises a variable diameter ablation element.

78. The ablation device of claim 77, wherein said variable diameter ablation element comprises a spiral member interconnected between said distal end of portion of said tube and said transparent tip, said tube being axially movable with respect to said tip to telescope said spiral member in and out to vary the outside diameter thereof.

79. The ablation device of claim 78, wherein said transparent tip comprises an elastic inflatable member.

80. The ablation device of claim 25, wherein said transparent tip comprised a blunt distal surface, said device further comprising a lens having a sharp configuration mounted between said transparent tip and a distal end of said endoscope.

81. The ablation device of claim 80, wherein said lens having a sharp configuration comprises a conical tip.

82. An ablation device for directly accessing a surgical site to perform ablation on a targeted tissue, said device comprising:

an elongated rigid or malleable tube having a distal end portion and a proximal end portion, said elongated tube having sufficient length so that at least a proximal end of the proximal end portion extends out of a patient when a distal end of the distal end portion contacts the targeted tissue;

an endoscope axially received within said elongated rigid or malleable tube;

a transparent tip axially aligned with said elongated tube, distally of said elongated tube, wherein said transparent tip enables direct viewing through the distal end of the device using said endoscope, and wherein said transparent tip is expandable to vary an outside diameter thereof; and

at least one ablation element mounted on said device for application of ablation energy to tissue when approximated by said device.

83. An ablation device for directly accessing a surgical site to perform ablation on a targeted tissue, said device comprising:

an elongated rigid or malleable tube having a distal end portion and a proximal end portion, said elongated tube having sufficient length so that at least a proximal end of the proximal end portion extends out of a patient when a distal end of the distal end portion contacts the targeted tissue; and

a variable diameter tip mounted to said distal end portion of said tube, said variable diameter tip adapted to contact tissue and apply at least one of an energy or chemical to the tissue to perform ablation of the tissue.

84. The ablation device of claim 83, further comprising an endoscope axially received within said elongated rigid or malleable tube;

85. The ablation device of claim 83, wherein said variable diameter tip comprises an expandable ring.

86. The ablation device of claim 85, wherein said expandable ring comprises an elastic spring coil.

87. The ablation device of claim 85, wherein said expandable ring functions as an ablation element.

88. The ablation device of claim 83, further comprising a plurality of pre-curved, elongated control members mounted to said variable diameter tip and extending into said tube, said elongated control members being slidable with respect to said tube to vary the diameter of said variable diameter tip.

89. The ablation device of claim 83, further comprising a plurality of secondary tubes passing within said elongated tube and configured to control movements of respective ones of said elongated control members therethrough.

90. The ablation device of claim 85, further comprising an expandable transparent diaphragm spanning said expandable ring.

91. The ablation device of claim 90, further comprising a sealing sleeve extending between said expandable ring and a distal end of said tube.

92. The ablation device of claim 88, further comprising a plurality of pre-curved, elongated control members mounted to said variable diameter tip and extending into said tube, and a sealing sleeve extending between said expandable ring and a distal end of said tube;

said elongated control members being slidable with respect to said tube and said sealing sleeve to vary the diameter of said variable diameter tip.

93. The ablation device of claim 84, wherein said endoscope is axially slidable, relative to said tube to vary a location of a distal end of said endoscope among a range of locations between a distal end of said tube and said variable diameter tip.

94. The ablation device of claim 84, wherein a distal end portion of said endoscope is articulatable to provide panning of a view while viewing through said endoscope

95. The ablation device of claim 83, wherein said variable tip diameter comprises a lens having overlapping edges, wherein rotation of one of said edges with respect to another of said edges varies the outside diameter of said lens.

96. The ablation device of claim 83, wherein said elongated tube includes a distal end portion wherein said tubing is split.

97. The ablation device of claim 96, further comprising a second tube coaxially passing within said elongated tube;

and elastic balloon member closing a distal end of said second tube; and

an endoscope coaxially passing within said second tube.

98. The ablation device of claim 97, wherein said elastic balloon member comprises a substantially flat distal end.

99. The ablation device of claim 97, further comprising an expandable ring mounted over distal end portions of said split tubing.

100. An ablation device for directly accessing a surgical site to perform ablation on a targeted tissue, said device comprising:

an elongated rigid or malleable tube;

a transparent distal tip mounted at a distal end of said tube;

a balloon member axially mounted over a distal end portion of said tube, proximal of said distal tip and fluidly connected to an opening through said tube for inflation of said balloon member by delivering pressurized fluid through said tube; and

an ablation element located within said balloon member

101. The ablation device of claim 100, further comprising an endoscope passing coaxially through at least a portion of said tube, said ablation element being located concentrically outside of a distal end portion of said endoscope.

102. The ablation device of claim 100, wherein said ablation element is adapted to deliver ultrasonic energy through said pressurized fluid and said balloon member to perform the ablation.

100-1. A dissection instrument comprising:

an elongated rigid or malleable tube having a distal end portion and a proximal end portion, said elongated tube having sufficient length so that at least a proximal end of the proximal end portion extends out of a patient when a distal end of the distal end portion contacts tissue as it is dissected;

an endoscope axially received within said elongated rigid or malleable tube;

a transparent blunt tip closing the distal end of said distal end portion, wherein said transparent blunt tip enables direct viewing through the distal end of the device using said endoscope; and

a transparent member having a sharp configuration mounted between said blunt tip and a distal end of said endoscope.

103. A device for facilitating the formation of an opening through an organ and for facilitating the delivery of at least one instrument through the opening, said device comprising:

an elongated main tube having proximal and distal ends;

a sewing ring located about said distal end; and

a one-way valve located within a proximal end portion of said main tube.

104. The device of claim 103, wherein said elongated main tube has a length sufficient to extend from a surface of the organ and proximally out of a percutaneous opening formed in a patient.

105. The device of claim 103, wherein said one-way valve substantially prevents blood flow proximally therethrough.

107. The dissection instrument of claim 106, further comprising a protrusion extending distally from a distal end surface of said transparent blunt tip, said protrusion configured to facilitate dissection.

108. The dissection instrument of claim 106, wherein said transparent member having a sharp configuration comprises a conical lens.

109. The dissection instrument of claim 106, further comprising a channel extending through at least a portion of a length of said elongated tube and extending through said transparent blunt tip.

110. The dissection instrument of claim 109, wherein said channel extends through a distal surface of said transparent blunt tip.

111. The dissection instrument of claim 109, further comprising a stylet adapted to be passed through said channel to extend out of said blunt tip to facilitate dissection.

112. An ablation device for directly accessing a surgical site to perform ablation on a targeted tissue, said device comprising:

an elongated rigid or malleable tube having a distal end portion and a proximal end portion, said elongated tube having sufficient length so that at least a proximal end of the proximal end portion extends out of a patient when a distal end of the distal end portion contacts the targeted tissue;

an endoscope axially received within said elongated rigid or malleable tube;

a transparent tip closing the distal end of said distal end portion, wherein said transparent tip enables direct viewing through the distal end of the device using said endoscope; and

at least one ablation element mounted on a distal end portion of said device.

113. The ablation device of claim 112, wherein said transparent tip comprises a flexible, substantially inelastic balloon.

114. The ablation device of claim 113, wherein said balloon, when deflated, is gathered about said distal end portion to reduce a profile of said device.

115. The ablation device of claim 113, wherein, when inflated, said balloon has a diameter substantially greater than a pulmonary vein ostium of a patient, thereby preventing said balloon and any portion of said device proximal of said balloon from entering the ostium.

116. The ablation device of claim 113, wherein said at least one ablation element is a flexible ablation element mounted on a distal surface of said balloon.

117. The ablation device of claim 113, wherein when said balloon is inflated, a distal end of said endoscope is positioned within said balloon.

118. The ablation device of claim 117, wherein when said distal end of said endoscope is axially positionable with said balloon to change a visual field viewed through said endoscope.

119. The ablation device of claim 113, wherein when said balloon comprises a protruding nipple on a distal face thereof.