Devices and methods for creating continuous lesions

Abstract

The present invention discloses devices and methods for creating multiple lesions using ablation devices in anatomical regions such as the heart, for example to treat cardiac arrhythmias. The present invention discloses methods and devices to create continuous lesions using area ablation devices. The present invention discloses various embodiments of reference assemblies for accurately positioning ablation devices having ablating portions, especially deployable ablation portions adapted for area ablation. The ablation devices are positioned using the reference assemblies in the anatomy to create one or more lesions. The present invention also discloses several method embodiments for creating continuous lesions using deployable ablating portions to produce two or more overlapping lesions.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an ablation device in accordance with various aspects of the present invention.

FIG. 2A is a side elevational view of the ablation device of FIG. 1.

FIG. 2B is an exemplary lesion pattern formed by the ablation device of FIG. 1.

FIGS. 3A and 3B are crossectional views of the ablation device of FIG. 1.

FIG. 4A is an elevational view of an exemplary delivery sheath, as part of a steering system, used in accordance with the present invention.

FIG. 4B is an elevational perspective view of an exemplary guide sheath, as part of a steering system, used in accordance with the present invention.

FIG. 4C is a perspective view depicting the delivery sheath of FIG. 4A and the guide sheath of FIG. 4B cooperating in accordance with various aspects of the present invention.

FIG. 4D is another perspective view depicting the delivery sheath of FIG. 4A and the guide sheath of FIG. 4B cooperating in accordance with various aspects of the present invention.

FIG. 4E is a perspective view depicting an exemplary embodiment of an ablation device cooperating with the steering system including the delivery sheath of FIG. 4A and the guide sheath of FIG. 4B.

FIG. 5A is a perspective view depicting another steering system, in accordance with various aspects of the present invention.

FIG. 5B is an elevational view depicting another steering system, in accordance with the various aspects of the present invention, the steering system in a first operative condition.

FIG. 5C is an elevational view depicting the steering system of FIG. 5B in a second operative condition.

FIGS. 5D-5E are elevational views depicting the steering systems of FIG. 5A and FIGS. 5B-5C in cooperative operation within the left atrium of a heart, in accordance with various aspects of the present invention.

FIGS. 6A-6B depict a method in accordance with certain aspects of the present invention.

FIGS. 6C-6D depict another method in accordance with various aspects of the present invention.

FIG. 6E depicts exemplary general points of interest within the left atrium of the heart and general approach geometries with respect to the points of interest.

FIGS. 7A-7P depict exemplary planar embodiments in accordance with various aspects of the present invention.

FIGS. 8A-8N depict additional exemplary planar embodiments in accordance with various aspects of the present invention.

FIGS. 9A-9B depict elevational views of an exemplary embodiment incorporating an ablating element in accordance with various aspects of the present invention.

FIGS. 9C-9D depict elevational views of another exemplary embodiment incorporating an ablating element in accordance with various aspects of the present invention.

FIG. 9E depicts an elevational view of another exemplary embodiment incorporating an ablating element in accordance with various aspects of the present invention.

FIGS. 9F-9G depict elevational views of another exemplary embodiment incorporating an ablating element in accordance with various aspects of the present invention.

FIGS. 10A-10B depict elevational views of another exemplary embodiment incorporating an ablating element in accordance with various aspects of the present invention.

FIG. 11A depicts an elevational view of another exemplary embodiment incorporating an ablating element in accordance with various aspects of the present invention.

FIGS. 11B-11C are crossectional views of the embodiment of FIG. 1A.

FIG. 11D depicts a defined point of flexing as part of the embodiment of FIG. 11A.

FIG. 11E depicts the embodiment of FIG. 11A in a collapse configuration for translation through a delivery system.

FIGS. 11F-11G depict the embodiment of FIG. 11A including multiple spline members engaging target tissue surfaces of differing contours.

FIG. 11H depicts an elevation view of another exemplary embodiment incorporating an ablating element in accordance with various aspects of the present invention.

FIG. 12A is a partial crossectional view of another embodiment in accordance with various aspects of the present invention.

FIG. 12B is a side perspective view of the embodiment of FIG. 12A.

FIG. 12C is a side elevation view of the embodiment of FIG. 12A.

FIGS. 12D and 12E are crossectional views of the embodiment of FIG. 12A.

FIG. 12F is a side elevation view of another embodiment in accordance with various aspects of the present invention.

FIG. 13A is a side elevation view of the embodiment of FIG. 12A depicting the distal portion in a collapse state allowing for transport via a delivery system.

FIG. 13B is another side elevation view of the embodiment of FIG. 12A depicting the distal portion in a collapsed state allowing for transport via a delivery system.

FIG. 13C is a crossectional view of the embodiment of FIG. 12A with the distal portion in a collapse state.

FIG. 14 is another exemplary embodiment, in accordance with various aspects of the present invention, incorporating a flexible joint structure.

FIGS. 15A-15B depict additional exemplary embodiments incorporating flexible joint structures.

FIG. 16 depicts the left lateral anatomic structures of the left atrium.

Claims

1. An ablation system for ablating a biological tissue comprising: a closed-loop reference assembly defining a first profile,an elongated ablation device having an ablating portion, the ablating portion adapted to be deployed from a relatively linear un-deployed first configuration to a relatively non-linear deployed second configuration, wherein the second configuration defines a second profile spatially separated from the first profile, anda deployment member from which the ablating portion can be deployed, wherein the deployment member is located along the closed loop reference assembly.

2. The ablation system of claim 1 wherein the biological tissue is cardiac tissue.

3. The ablation system of claim 1, wherein the ablating portion is adapted to transmit an ablative energy selected from the group consisting of RF energy, microwave energy, ultrasound energy, thermal energy, cryogenic energy and infrared energy.

4. The ablation system of claim 1, wherein the ablating portion is adapted to transmit high energy particles.

5. The ablation system of claim 4, wherein the high energy particles are selected from the group consisting of ionized particles, electrons, X-ray photons, ultraviolet photons, and gamma photons.

6. The ablative device of claim 1, wherein the ablating portion is adapted to release an ablative chemical.

7. The ablation system of claim 1 wherein the second configuration is substantially annular.

8. The ablation system of claim 1 wherein the closed loop reference assembly comprises a springy member.

9. The ablation system of claim 8, wherein the springy member is formed from material selected from the group consisting of nitinol and stainless steel.

10. The ablation system of claim 8, wherein the closed loop reference assembly further comprises a hinge for rotatably interfacing the springy member to the remainder of the reference assembly.

11. The ablation system of claim 1, wherein the closed loop reference assembly comprises at least one tubular member.

12. The ablation system of claim 11, wherein the deployment member is the distal end of the at least one tubular member.

13. The ablation system of claim 1, further including a mean to define a series of spatial relationships between a deployed ablation device and the reference assembly.

14. The ablation system of claim 1, wherein the closed loop created by the reference assembly is deployable from a contracted configuration to an expanded configuration.

15. The ablation system of claim 1, wherein the ablating portion is substantially planar.

16. The ablation system of claim 1, wherein the volume of ablating portion is unchangeable.

17. The ablation system of claim 1 wherein the reference assembly is adapted to engage at least a portion of the closed loop to an anatomical structure.

18. The ablation system of claim 17, wherein the anatomical structure is a tissue surface of the heart.

19. The ablation system of claim 17, wherein the anatomical structure is a pulmonary vein.

20. A method of creating a continuous lesion in biological tissue, comprising the steps of: providing a medical device comprising an ablating portion, the ablating portion adapted to be deployed from a relatively linear un-deployed first configuration to a relatively non linear deployed second configuration, wherein the ablating portion is adapted to ablate a tissue area,positioning the ablating portion adjacent to a first tissue location,creating a first lesion in a portion of the first tissue location adjacent to the ablating portion,moving the ablating portion adjacent to a second tissue location,creating a second lesion in a portion of the second tissue location adjacent to the ablating portion,wherein the first and the second lesions are continuous.

21. The method of claim 20, wherein the tissue area does not include an anatomical opening.

22. The method of claim 21, wherein the anatomical opening is an ostium of a pulmonary vein.

23. The method of claim 20, wherein the biological tissue is cardiac tissue.

24. The method of claim 20, wherein the ablating portion is adapted to ablate at least the tissue along the periphery of the ablating portion.

25. The method of claim 20, wherein the ablating portion is adapted to ablate all the tissue within the periphery of the ablating portion.

26. The method of claim 20, wherein the tissue includes an anatomical opening.

27. The method of claim 20, wherein the volume of the ablating portion in the first configuration and the second configuration is the same.

28. The method of claim 20, wherein the ablating portion is substantially planar.

29. An ablation device for ablating a biological tissue comprising: a) an ablating portion adapted to be deployed from a relatively linear un-deployed first configuration to a relatively non linear deployed second configuration;b) an elongate reference element; andc) a positioning element adapted to cooperate with the elongate reference element to define multiple relative positions of the positioning element relative to the reference element,wherein the ablating portion is deployable from the positioning element from multiple locations along the length of the positioning element.

30. The ablation device of claim 29, wherein the ablating portion further comprises an ablative energy transmitting element.

31. The ablation device of claim 30, wherein the ablating portion is adapted to transmit an ablative energy selected from the group consisting of RF energy, microwave energy, ultrasound energy, thermal energy, cryogenic energy and infrared energy.

32. The ablation device of claim 29, wherein the ablating portion is adapted to transmit high energy particles.

33. The ablative device of claim 32, wherein the high energy particles are selected from the group consisting of ionized particles, electrons, X-ray photons, ultraviolet photons, and gamma photons.

34. The ablative device of claim 29, wherein the ablating portion is adapted to release an ablative chemical.

35. The ablation device of claim 29, wherein the ablating portion is adapted to ablate at least the tissue along the periphery of the ablating portion.

36. The ablation device of claim 29, wherein at least one physical dimension of the ablating portion is adjustable.

37. The ablation device of claim 29, wherein the ablating portion includes a microwave antenna selected from the group consisting of circular antenna, annular antenna, elliptical antenna, loop antenna, linear antenna, curvilinear antenna and planar antenna.

38. The ablation device of claim 29, wherein the ablating portion is adapted to ablate an area of biological tissue.

39. The ablation device of claim 29, wherein the positioning element is deflectable.

40. The ablation device of claim 29, wherein the positioning element comprises at least one electrode.

41. The ablation device of claim 29, wherein the positioning element is rotatable about the reference element.

42. The ablation device of claim 29, wherein the reference element is adapted to be stabilized in an anatomical structure.

43. The ablation device of claim 42, wherein the reference comprises an anchoring element.

44. The ablation device of 43, wherein the anchoring element is an inflatable anchoring device.

45. The ablation device of claim 29, wherein the ablating portion consists of only one energy transmitting element.

46. The ablation device of claim 29, wherein the ablation device is adapted to be introduced through a lumen of a trans-septal sheath.

47. The ablation device of claim 29, wherein one of the multiple locations along the length of the positioning device is located proximal to the distal end of the positioning device.

48. An ablation device for ablating a biological tissue comprising: a) a closed-loop reference assembly deployable from a low-profile, non-deployed configuration to a high-profile, deployed configuration, the loop comprising a first section and a second section wherein the first section is stiffer than the second section, such that the second section is deployable in the anatomy in multiple positions relative to the first section; andb) an ablating portion positioned along a portion of the second section of the reference assembly, wherein the ablating portion is adapted to be deployed from a relatively linear, non-deployed first configuration to a relatively non-linear, deployed second configuration.

49. The ablation device of claim 48, wherein the ablation device is insertable through a trans-septal sheath.

50. The ablation device of claim 48, wherein the ablating portion is adapted to transmit an ablative energy selected from the group consisting of RF energy, microwave energy, ultrasound energy, thermal energy, cryogenic energy and infrared energy.

51. The ablation device of claim 48, wherein the ablating portion is adapted to transmit high energy particles.

52. The ablative device of claim 48, wherein the high energy particles are selected from the group consisting of ionized particles, electrons, X-ray photons, ultraviolet photons, and gamma photons.

53. The ablative device of claim 48, wherein the ablating portion is adapted to release an ablative chemical.

54. The ablation device of claim 48, wherein the ablating portion is adapted to ablate at least the tissue along the periphery of the ablating portion.

55. The ablation device of claim 48, wherein one physical dimension of the ablating portion is adjustable.

56. The ablation device of claim 48, wherein the ablating portion includes a microwave antenna selected from the group consisting of circular antenna, annular antenna, elliptical antenna, loop antenna, linear antenna, curvilinear antenna and planar antenna.

57. The ablation device of claim 48, wherein the ablating portion is adapted to ablate an area of biological tissue.

58. The ablation device of claim 48, wherein the shape of the closed-loop reference assembly can be modified by deploying the second section while maintaining the first section stable.

59. The ablation device of claim 48, wherein the ablating portion includes only one ablative element.

60. An ablation system for ablating biological tissue at a location with respect to a reference, comprising: an elongate guide sheath having a distal portion and a lumen therethrough defining a distal opening, the distal portion of the guide sheath forming at least one spline portion having a distal end;an elongate reference member having a distal portion, the elongate reference member slidably disposed within the lumen of the elongate guide sheath; andan alignment member having first and second sections, the first section attached to the distal portion of the elongate reference member and the second section attached to the elongate guide sheath at the distal end of the at least one spline, the alignment member including an ablating portion adjacent the second section adapted to transmit ablative energy therefrom, the ablating portion including at least one ablating element.wherein the at least one spline portion cooperates with the alignment member to define an ablation zone at the location with respect to the reference.

61. The ablation system of claim 60, wherein the distal portion of the guide sheath forms at least two spline portions.

62. The ablation system of claim 61, wherein the at least two spline portions are equally spaced radially about the elongate guide sheath.

63. The ablation system of claim 60, wherein the distal portion of the elongate reference member includes one or more electrodes thereon for transceiving electrophysiological signals to and from biological tissue.

64. The ablation system of claim 63, wherein the electrodes are used to determine tissue contact between the elongate reference member and the biological tissue.

65. The ablation system of claim 60, wherein the distal portion of the elongate reference member includes at least one radio-opaque element, wherein the radio-opaque element is visible under fluoroscopy to provide an indication of the orientation of the elongate reference member with respect to the biological tissue.

66. The ablation system of claim 60, wherein the alignment member includes at least one deflection point defined along its length.

67. The ablation system of claim 66, wherein the alignment member includes at least one recessed area to define the at least one deflection point thereon.

68. The ablation system of claim 67 wherein the recessed area is located within the width of the alignment member.

69. The ablation system of claim 67, wherein the recessed area includes a side portion of the alignment member.

70. The ablation system of claim 60, wherein the at least one ablative element is an antenna adapted to emit electromagnetic energy.

71. The ablation system of claim 60, wherein the at least one ablative element is an electrode adapted to emit RF energy.

72. The ablation system of claim 60, wherein the at least one ablative element is positioned at least between the alignment member and the biological tissue, the alignment member encouraging contact between the at least one ablative element and the biological tissue.

73. The ablation system of claim 60, wherein the alignment member includes at least one electrode thereon for acquiring electrophysiological information from the biological tissue.

74. The ablation system of claim 73, wherein the information received is used to assess the ablation of the biological tissue.

75. The ablation system of claim 70, wherein the ablating portion is linear.

76. The ablation system of claim 75, wherein the antenna is positioned along an alignment member surface.

77. The ablation system of claim 60, wherein the reference is the elongate reference member.

78. The ablation system of claim 60, wherein the reference is an anatomical structure.

79. The ablation system of claim 78, wherein the anatomical structure is a pulmonary vein structure.

80. The ablation system of claim 79, wherein the pulmonary vein structure is the ostium.

81. The ablation system of claim 80, wherein the location is at a distance of about 5mm to about I Omm from the reference.

82. The ablation system of claim 78, wherein the anatomical structure is a left atrial appendage.