CA2361157A1 - Circumferential ablation device assembly and methods of use and manufacture providing an ablative circumferential band along an expandable member - Google Patents

Circumferential ablation device assembly and methods of use and manufacture providing an ablative circumferential band along an expandable member Download PDF

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Publication number
CA2361157A1
CA2361157A1 CA002361157A CA2361157A CA2361157A1 CA 2361157 A1 CA2361157 A1 CA 2361157A1 CA 002361157 A CA002361157 A CA 002361157A CA 2361157 A CA2361157 A CA 2361157A CA 2361157 A1 CA2361157 A1 CA 2361157A1
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assembly
permeable
along
ablation
fluid
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CA002361157A
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French (fr)
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CA2361157C (en
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Mark A. Maguire
James C. Peacock, Iii
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Atrionix Inc
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Individual
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N7/02—Localised ultrasound hyperthermia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A61B2017/00256—Creating an electrical block
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A61B2017/00318—Steering mechanisms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A61B2018/00023—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids closed, i.e. without wound contact by the fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00059—Material properties
    • A61B2018/00065—Material properties porous
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00107—Coatings on the energy applicator
    • A61B2018/00136—Coatings on the energy applicator with polymer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/0022—Balloons
    • A61B2018/00238—Balloons porous
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A61B2018/00369—Heart valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A61B2018/00815—Temperature measured by a thermistor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A61B2018/00821—Temperature measured by a thermocouple
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B2018/044—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating the surgical action being effected by a circulating hot fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/49002—Electrical device making
    • Y10T29/49117—Conductor or circuit manufacturing
    • Y10T29/49169—Assembling electrical component directly to terminal or elongated conductor
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/49826—Assembling or joining
    • Y10T29/49888—Subsequently coating
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/4998—Combined manufacture including applying or shaping of fluent material
    • Y10T29/49982—Coating

Abstract

A medical balloon catheter assembly includes a balloon having a permeable region and a non-permeable region. The balloon is constructed at least in pa rt from a fluid permeable tube such that the permeable region is formed from a porous material which allows a volume of pressurized fluid to pass from with in a chamber formed by the balloon and into the permeable region sufficiently such that the fluid may be ablatively coupled to tissue engaged by the permeable region. The non-permeable region is adapted to substantially block the pressurized fluid from passing from within the chamber and outwardly fro m the balloon. Such voids may be created by expanding the fluoropolymer. The porous material extends along both the permeable and non-permeable regions. In one mode of this construction, the material is porous along the permeable region and non-porous along the non-permeable region, such as by expanding only the permeable region. The pores in may also be provided along both permeable and non-permeable sections but are a dip coated, deposited, or extruded material along the non-permeable section in order to prevent fluid from passing therethrough. The insulator material may in one mode be provide d in many shapes on the surface of the balloon.

Claims (95)

1. An ablation device assembly for ablating a circumferential region of tissue at a location where a pulmonary vein extends from an atrium in a patient, comprising:
an elongate body with a proximal end portion, a distal end portion, and a longitudinal axis; and an expandable member located along the distal end portion and having a working length that is expandable from a radially collapsed condition to a radially expanded condition, wherein in the radially expanded condition, the working length comprises first and second end portions and an intermediate region extending between the first and second end portions relative to the longitudinal axis, the working length enclosing at least in-part a chamber which is adapted to couple to a source of an ablation medium, the intermediate region having an expanded outer diameter which is adapted to engage a substantial portion of the circumferential region of tissue, the intermediate region comprising a porous fluoropolymer which is sufficiently permeable to allow a volume of ablation medium within the chamber to he ablatively coupled to the substantial portion of the circumferential region of tissue engaged by the intermediate region, and the first and second end portions being substantially non-permeable to substantially prevent the volume of ablation medium within the chamber from ablatively coupling to tissue adjacent to the first and second end portions.
2. The assembly of claim 1, wherein the porous fluoropolymer material has a plurality of apertures formed therethrough such that the volume of ablation medium is adapted to be ablatively coupled to the substantial portion of the circumferential region of tissue primarily through the apertures.
3. The assembly of claim 1, wherein the porous fluoropolymer material has an inherent void volume such that the volume of ablation medium is adapted to be ablatively coupled to the substantial portion of the circumferential region of tissue primarily through the void volume.
4. The assembly of claim 1, further comprising a guidewire tracking member along the distal end portion of the elongate body and which is adapted to slideably engage and track over a guidewire positioned within the body space.
5. The assembly of claim 4, wherein the guidewire tracking member further comprises a guidewire passageway which extends along the elongate body between a proximal guidewire port located along the proximal end portion and a distal guidewire port located along the distal end portion.
6. The assembly of claim 1, wherein the expandable member further comprises a balloon which includes a balloon skin that forms the chamber and also the working length and which is inflatable with the ablation medium in order to expand from the radially collapsed condition to the radially expanded condition.
7. The assembly of claim 6, wherein the porous fluoropolymer material forms at least in part the balloon skin along the intermediate region and the balloon skin along the first and second end portions comprises an elastomer.
8. The assembly of claim 7, wherein the elastomer is selected from the group of materials consisting of polyurethane, silicone, mylar, latex, and combinations and blends thereof.
9. The assembly of claim 7, wherein the elastomer exhibits at least about a 400% elastic expansion before yield.
10. The assembly of claim 6, wherein the balloon has a profile in the radially collapsed condition which is between about 0.485 and 3.962 millimeters, inclusive, and the expanded outer diameter is between about 10 and 25 millimeters, also inclusive.
11. The assembly of claim 1, wherein the intermediate region forms a circumferential band which circumscribes the working length.
12. The assembly of claim 11, wherein the circumferential band has a band length relative to the longitudinal axis and which is substantially shorter than the working length.
13. The assembly of claim 12, wherein the band length is less than about two-thirds the working length.
14. The assembly of claim 1, wherein the elongate body further comprises:
a fluid passageway extending between a proximal port, which is located along the proximal end portion and is adapted to couple to the pressurizeable fluid source, and a distal part, which is located along the distal end portion and through which the fluid passageway is fluidly coupled to the chamber.
15. The assembly of claim 1, wherein the expandable member further comprises:
first and second expandable elements along the first and second end portions, respectively, and also includes a permeable membrane with two opposite end portions engaged to the first and second expandable elements and also with an intermediate portion extending between the first and second expandable elements, the chamber being formed at least in-part by the first and second expandable elements and the permeable membrane such that the intermediate portion of the permeable membrane forms the intermediate region of the expandable member.
16. The assembly of claim 15, wherein the first and second expandable elements are adapted to expand primarily by stretching and wherein the intermediate portion is adapted to expand primarily by unfolding.
17. The assembly of claim 15, wherein at least one of the expandable elements is an inflatable balloon.
18. The assembly of claim 1, wherein the working length has a proximal end and a distal end and also has a tapered shape with a distally reducing outer diameter from the proximal end to the distal end.
19. The assembly of claim 18, wherein the tapered shape is "pear"-shaped and has a contoured surface between the proximal end and the distal end, the intermediate region being positioned along the contoured surface adjacent the proximal end.
20. The assembly of claim 1, further comprising an electrical current source which is adapted to electrically couple to an ablation electrode in an RF ablation circuit such that current flows from the electrical current source, through the ablation electrode, into the volume of ablation medium within the chamber, through the intermediate region, into the substantial portion of the circumferential region of tissue, and into a return electrode coupled to the patient and also to the electrical current source.
21. The assembly of claim 1, further comprising an expansion actuator which is adapted to expand the expandable member from the radially collapsed condition to the radially expanded condition.
22. The assembly of claim 1, further comprising a pressurizeable source of electrically conductive fluid which is adapted to fluidly couple to the chamber.
23. The assembly of claim 1, further comprising an ultrasound ablation element.
24. The assembly of claim 1, further comprising a thermal ablation element.
25. The assembly of claim 1, further comprising a cryogenic ablation element.
26. The assembly of claim 1, further comprising a light emitting ablation element.
27. The assembly of claim 1, further comprising a microwave ablation element.
28. The assembly of claim 1, further comprising a fluid ablation element.
29. The assembly of claim 1, further comprising an electrical ablation element.
30. The assembly of claim 1, wherein the porous fluoropolymer material further comprises a plurality of pores which in the radially expanded condition are adapted to substantially allow the pressurized fluid to pass from within the enclosed chamber and outwardly through and from the balloon.
31. The assembly of claim 30, wherein the plurality of pores comprise an inherent void volume in the porous fluoropolymer material.
32. The assembly of claim 30, wherein the porous fluoropolymer material comprises a porous polytetrafluoroethylene material.
33. The assembly of claim 32, wherein the porous polytetrafluoroethylene material further comprises a plurality of nodes which are interconnected by a plurality of fibrils, the plurality of pores being formed by voids which are located between the nodes and fibrils.
34. The assembly of claim 32, wherein the porous polytetrafluoroethylene material has a length and the plurality of pores are located along the length, and the porous polytetrafluoroethylene material extends along both the non-permeable and permeable sections, and further wherein the pores along the non-permeable section are substantially blocked and non-permeable to the pressurized fluid within the chamber and the pores along the permeable section are substantially open and permeable to pressurized fluid within the chamber.
35. The assembly of claim 34, wherein the pores along the non-permeable section are substantially blocked with an insulator material.
36. The assembly of claim 35, wherein the insulator material comprises a polymer.
37. The assembly of claim 36, wherein the polymer comprises an elastomer.
38. The assembly of claim 35, wherein the insulator material comprises a deposited material along the non-permeable section.
39. The assembly of claim 38, wherein the deposited material is chosen from the group consisting of plasma deposited materials, vapor deposited materials, ion beam deposited materials, sputter coated materials, and combinations thereof.
40. The assembly of claim 35, wherein the insulator material comprises a thermoplastic material which is melted to the porous polytetrafluoroethylene material along the non-permeable section.
41. The assembly of claim 35, wherein the porous polytetrafluoroethylene material further comprises an outer surface, and the insulator material further comprises a coating over the outer surface.
42. The assembly of claim 41, wherein the insulator material comprises a dip-coated material.
43. The assembly of claim 35, wherein the insulator material substantially fills the pores along the non-permeable section.
44. The assembly of claim 35, wherein the insulator material substantially covers the pores along the non-permeable section.
45. The assembly of claim 44, wherein the insulator material comprises a tubular material which is positioned in a coaxial relationship relative to the porous polytetrafluoroethylene material along the non-permeable section.
46. The assembly of claim 45, wherein the porous polytetrafluoroethylene material further comprises an outer surface, and the tubular material is coaxially positioned over the outer surface.
47. The assembly of claim 45, wherein the tubular material comprises an elastomer.
48. The assembly of claim 45, wherein the tubular material is adhered to the porous polytetrafluoroethylene material.
49. The assembly of claim 45, wherein the tubular material is un-adhered to the porous polytetrafluoroethylene material.
50. The assembly of claim 49, wherein the porous polytetrafluoroethylene material further comprises a porous tube which is relatively non-compliant; and the tubular material further comprises an elastomer which is relatively compliant;
such that the balloon in the radially collapsed condition is characterized by the porous polytetrafluoroethylene material in a folded condition and also by the tubular material in a relatively non-stretched condition, and the balloon in the radially expanded condition is characterized by the porous polytetrafluoroethylene material in an unfolded condition and also by the tubular material in a radially stretched condition.
51. The assembly of claim 1, wherein the porous fluoropolymer material is formed from a tape which is oriented with adjacent windings which are secured to each other to form a continuous porous tube that defines at least in part the chamber.
52. The assembly of claim 1, the working length further comprising a polytetrafluoroethylene material having a length which extends along the first and second end portions and the intermediate region, the polytetrafluoroethylene material further being substantially non-porous along the first and second end portions and porous along the intermediate region.
53. The assembly of claim 52, wherein the polytetrafluoroethylene material along the first and second end portions further comprises a plurality of non-permeable pores which are sufficiently small to prevent passage of the pressurized fluid from within the chamber and outwardly from the balloon through the first and second end portions.
54. The assembly of claim 53, wherein:
the polytetrafluoroethylene material further comprises a plurality of nodes which are interconnected by a plurality of fibrils such that the plurality of pores are formed by voids between the nodes and the fibrils; and the polytetrafluoroethylene material along the first and second end portions further comprises a second plurality of nodes which are interconnected by a second plurality of fibrils such that non-permeable pores are formed from a plurality of non-permeable voids between the second plurality of nodes and the second plurality of fibrils.
55. The assembly of claim 52, wherein the polytetrafluoroethylene material is expanded along the porous intermediate region and is relatively un-expanded along the first and second end portions.
56. The assembly of claim 30, wherein the working length further comprises first and second end portions with an intermediate region extending therebetween relative to the longitudinal axis, the first end portion comprising the non-permeable section, the intermediate region comprising the permeable section, and the second end portion comprising a second non-permeable section which is constructed to substantially prevent a volume of pressurized fluid from passing from within the chamber and radially outwardly through and from the balloon.
57. The assembly of claim 56, wherein the permeable section further comprises a circumferential band which circumscribes the working length along the intermediate region.
58. The assembly of claim 56, wherein the working length has a proximal section and a distal section and a tapered region with a distally reducing outer diameter from the proximal section to the distal section, and the permeable section is located along the tapered section.
59. The assembly of claim 56, wherein the permeable section is located proximally adjacent to non-permeable section.
60. The assembly of claim 1, wherein the intermediate region is further constructed to allow a volume of electrically conductive fluid to pass from within the chamber and outwardly through and from the balloon through the pores, and further comprising:
an ablation electrode which is constructed to electrically couple to an electrical current source and also to the volume of electrically conductive fluid within the chamber.
61. A method for forming a medical balloon catheter device assembly which is adapted to deliver a volume of fluid to a region of tissue in a body, comprising:
providing a fluid permeable tube having a first end portion, a second end portion, a permeable section formed at least in part from a porous material with a plurality of pores which are adapted to allow a volume of pressurized fluid to pass from within and outwardly through the tube, and also having a non-permeable section which is adapted to substantially prevent the volume of pressurized fluid from passing from within and outwardly through the tube;

securing the first and second end portions to a distal end portion of an elongate catheter body such that the fluid permeable tube forms at least in part a balloon which defines a pressurizeable chamber aver the catheter body and which includes a working length that is adapted to radially expand from a radially collapsed condition to a radially expanded condition when the chamber is filled with the pressurized fluid, wherein the permeable section is positioned only along the working length; and coupling the pressurizeable chamber with a distal port of a fluid passageway that extends along the catheter body between the distal port and a proximal port along the proximal end portion of the elongate catheter body which is adapted to couple to a pressurizeable fluid source.
62. The method of claim 61, further comprising after securing the end portions of the balloon along the elongate catheter body, sterilizing the balloon and elongate catheter body.
63. The method of claim 61, further comprising forming a taper along the working length of the balloon having a distally reducing outer diameter, and positioning the permeable section along the taper.
64. The method of claim 63, further comprising positioning the non-permeable section along the taper.
65. The method of claim 61, wherein the fluid permeable tube is formed at least in part from a porous fluoropolymer having a plurality of voids which form the pores.
66. The method of claim 65, wherein the porous fluoropolymer includes a plurality of nodes which are interconnected with fibrils to form a node-fibril network such that the plurality of voids are formed between the nodes and interconnecting fibrils.
67. The method of claim 61, further comprising providing an ablation electrode to electrically couple to an electrical current source and also to the permeable section when the pressurizeable chamber is filled with an electrically conductive fluid.
68. The method of claim 67, further comprising securing the ablation electrode to the distal end portion of the elongate catheter body, and securing the fluid permeable tube to the elongate catheter body on opposite sides of the ablation electrode such that the ablation electrode is positioned within the chamber.
69. The method of claim 61, wherein both the permeable and non-permeable sections of the fluid permeable tube are formed at least in part from the porous material.
70. The method of claim 69, wherein both the permeable and the non-permeable sections of the fluid permeable tube, and further comprising substantially blocking the pores along the non-permeable section such that the blocked pores are substantially non-permeable to the volume of fluid when the fluid is pressurized.
71. The method of claim 70, further comprising substantially blocking the pores along the non-permeable section with an insulator material.
72. The method of claim 71, wherein substantially blocking the pores comprises dip coating the non-permeable section with the insulator material.
73. The method of claim 71, wherein substantially blocking the pores comprises melting the insulator material to the non-permeable section.
74. The method of claim 71, wherein substantially blocking the pores comprises depositing the insulator material along the non-permeable section.
75. The method of claim 74, wherein depositing the insulator along the non-permeable section is accomplished according to a deposition process selected from the group consisting of plasma depositing, vapor depositing, and ion beam depositing.
76. The method of claim 71, further comprising:
substantially blocking the pores along both the permeable section and the non-permeable section with the insulator material; and selectively removing the insulator material such that the pores along the permeable section are left open and m-blocked and the pores along the non-permeable section are left blocked.
77. The method of claim 76, wherein selectively removing the insulator material from the permeable section comprises dissolving the insulator material along the permeable section with a solvent.
78. The method of claim 77, further comprising selectively masking the insulator material along the non-permeable section from being exposed to and dissolved by the solvent.
79. A tissue ablation device assembly for ablating a circumferential region of tissue at a location where a pulmonary vein extends from an atrium, comprising:
a circumferential ablation member with an ablation element which is adapted to ablatively couple to the circumferential region of tissue; and a steerable delivery member with a proximal end portion and a distal end portion which is deflectable and steerable by rotating the proximal end portion such that the distal end portion may be positioned along the location, wherein the circumferential ablation member is adapted to couple to the distal end portion of the steerable delivery member and to be delivered to the location by the steerable delivery member.
80. The assembly of claim 79, wherein the ablation element is an ultrasound ablation element.
81. The assembly of claim 79, wherein the ablation element is a thermal ablation element.
82. The assembly of claim 79, wherein the ablation element is a cryogenic ablation element.
83. The assembly of claim 79, wherein the ablation element is a light emitting ablation element.
84. The assembly of claim 79, wherein the ablation element is a microwave ablation element.
85. The assembly of claim 79, wherein the ablation element is a fluid ablation element.
86. The assembly of claim 79, wherein the ablation element comprises an electrical ablation element.
87. The assembly of claim 79, further comprising an expandable member located along the distal end portion and having a working length that is expandable from a radially collapsed condition to a radially expanded condition, wherein in the radially expanded condition, the working length comprises first and second end portions and an intermediate region extending between the first and second end portions relative to the longitudinal axis, the working length enclosing at least in-part a chamber which is adapted to couple to a source of an ablation medium, the intermediate region having an expanded outer diameter which is adapted to engage a substantial portion of the circumferential region of tissue, the intermediate region comprising a porous fluoropolymer which is sufficiently permeable to allow a volume of ablation medium within the chamber to be ablatively coupled to the substantial portion of the circumferential region of tissue engaged by the intermediate region, and the first and second end portions being substantially non-permeable to substantially prevent the volume of ablation medium within the chamber from ablatively coupling to tissue directly across the first and second end portions.
88. A tissue ablation device assembly for ablating a circumferential region of tissue at a location where a pulmonary vein extends from an atrium, comprising:
an elongate body with a proximal end portion and a distal end portion;
a circumferential ablation member with an expandable member having first and second end portions with first and second expandable elements, respectively, and also an intermediate region between the first and second end portions with an outer skin extending between the first and second expandable elements such that a fluid chamber is formed at least in part by the first and second expandable elements and the outer skin, wherein the fluid chamber is adapted to be fluidly coupled to a pressurizeable source of fluid, and the outer skin has a permeable section that is substantially permeable to a volume of fluid within the chamber.
89. The assembly of claim 88, wherein the circumferential ablation member further comprises an ultrasound ablation element.
90. The assembly of claim 88, wherein the circumferential ablation member further comprises a thermal ablation element.
91. The assembly of claim 88, wherein the circumferential ablation member further comprises a cryogenic ablation element.
92. The assembly of claim 88, wherein the circumferential ablation member further comprises a light emitting ablation element.
93. The assembly of claim 88, wherein the circumferential ablation member further comprises a microwave ablation element.
94. The assembly of claim 88, wherein the circumferential ablation member further comprises a fluid ablation element.
95. The assembly of claim 88, wherein the circumferential ablation member further comprises an electrical ablation element.
CA2361157A 1999-03-19 2000-03-17 Circumferential ablation device assembly and methods of use and manufacture providing an ablative circumferential band along an expandable member Expired - Lifetime CA2361157C (en)

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US09/435,283 US6500174B1 (en) 1997-07-08 1999-11-05 Circumferential ablation device assembly and methods of use and manufacture providing an ablative circumferential band along an expandable member
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US20040260277A1 (en) 2004-12-23
US6500174B1 (en) 2002-12-31
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US6954977B2 (en) 2005-10-18
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US7241295B2 (en) 2007-07-10
US6758847B2 (en) 2004-07-06
US20030083653A1 (en) 2003-05-01
WO2000056237A9 (en) 2002-04-18
JP4491149B2 (en) 2010-06-30
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CA2361157C (en) 2010-06-29
WO2000056237A2 (en) 2000-09-28

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