Tissue ablation device assembly and method for electrically isolating a pulmonary vein ostium from an atrial wall

• US 7,340,307 B2
• Filed: 11/24/2004
• Issued: 03/04/2008
• Est. Priority Date: 07/08/1997
• Status: Expired due to Fees

• Current Assignee: Atrionix, Inc. (Johnson & Johnson)
• Original Assignee: Atrionix, Inc. (Johnson & Johnson)
• Inventors: Maguire, Mark A., Carcamo, Edward L., Lesh, Michael D., Peacock, James C. III
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US10/996,523
• Publication Number:
  US 20060084966A1
• Time in Patent Office: 1,196 Days
• Field of Search: 607/96, 607/99, 607/104, 607/105, 607/113, 607/122, 606/41, 128/898
• US Class Current: 607/41
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00065 porous
• CPC Class Codes: A61B 2018/00101 low, i.e. thermally insulating
• CPC Class Codes: A61B 2018/00148 with metal
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00232 having an irregular shape
• CPC Class Codes: A61B 2018/00238 porous
• CPC Class Codes: A61B 2018/143 multiple needles
• CPC Class Codes: A61B 2018/1432 curved
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

This invention is related to a tissue ablation system and method that treats atrial arrhythmia by ablating a circumferential region of tissue at a location where a pulmonary vein extends from an atrium. The system includes a circumferential ablation member with an ablation element and also includes a delivery assembly for delivering the ablation member to the location. The circumferential ablation member is generally adjustable between different configurations to allow both the delivery through a delivery sheath into the atrium and the ablative coupling between the ablation element and the circumferential region of tissue.

Claims

1. A tissue ablation system for treating atrial arrhythmia by ablating a circumferential region of tissue at a location where a pulmonary vein extends from an atrium, comprising:

a delivery member having a proximal end portion and a distal end portion with a longitudinal axis and a radial axis;

a cantilevered housing having a first end, a second end, and a distal wall, that is located at least in part along the distal end portion, and that is mechanically adjustable between a first condition and a second condition, wherein in the first condition the distal wall is substantially radially collapsed such that the housing is adapted to be delivered through a delivery sheath into the atrium, and wherein in the second condition the second end and the distal wall are radially extended at least in part from the longitudinal axis, the distal wall having a distal orientation and a distal facing surface substantially perpendicular to the longitudinal axis located along a circumferential region that surrounds the longitudinal axis;

a mechanical positioning assembly coupled to the first end of the housing to mechanically adjust the housing between the first and second conditions; and

an ablation element cooperating with the housing and which is adapted to ablatively couple to a circumferential area normal to the distal facing surface along the circumferential region when the housing is in the second position,

wherein the ablation element and distal facing surface are configured such that the circumferential area coincides with the circumferential region of tissue when the housing is adjusted to the second condition at the location.

2. The system of claim 1, wherein

in the second condition the distal wall along the circumferential region comprises a first membrane and an opposing substantially porous second membrane that together enclose at least in part a void space within the housing;

the distal facing surface is located along the porous membrane; and

the porous membrane is adapted to ablatively couple a volume of ablative fluid within the void space to the circumferential area.

3. The system of claim 2, wherein the porous membrane is adapted to allow the volume of ablative fluid to flow from within the void space into the circumferential area.

4. The system of claim 2, wherein the ablation element comprises a volume of ablative fluid medium within the void space and that ablatively couples with the circumferential area across the porous membrane.

5. The system of claim 2, wherein the porous membrane comprises a porous tetrafluoropolymer.

6. The system of claim 2, wherein the ablation element comprises an ablative energy source located within the void space.

7. The system of claim 1, wherein the mechanical positioning assembly is coupled to the delivery member.

8. The system of claim 1, wherein the mechanical positioning assembly comprises an array of splines that are circumferentially spaced around the longitudinal axis, each spline having a distal end portion coupled to the distally oriented wall and a proximal end portion coupled to the distal end portion, and wherein each of the array of splines is adjustable between a first position which is substantially radially collapsed and extending along the longitudinal axis and a second position wherein the distal end portion of the spline extends radially outwardly from the longitudinal axis, such that the first and second positions for the splines characterize at least in part the first and second conditions for the housing.

9. The system of claim 8, wherein the ablation element comprises an energy source that is located along a spline at a position corresponding to the circumferential region.

10. The system of claim 1 wherein the ablation element comprises an ablation means.

11. The system of claim 1, wherein the ablation element comprises a microwave ablation element.

12. The system of claim 1, wherein the ablation element comprises a cryogenic ablation element.

13. The system of claim 1, wherein the ablation element comprises a thermal ablation element.

14. The system of claim 1, wherein the ablation element comprises a light emitting ablation element.

15. The system of claim 1, wherein the ablation element comprises an ultrasonic ablation element.

16. a tissue ablation system for treating atrial arrhythmia by ablating a circumferential region of tissue at a location where a pulmonary vein extends from an atrium, comprising:

a delivery member having a proximal end portion and a distal end portion with a longitudinal axis and a radial axis;

a cantilevered housing having a first end, a second end, and a distal wall, that is located at least in part along the distal end portion, and that is mechanically adjustable between a first condition and a second condition, wherein in the first condition the distal wall is substantially radially collapsed such that the housing is adapted to be delivered through a delivery sheath into the atrium, and wherein in the second condition the second end is radially extended at least in part from the longitudinal axis, the distal wall having a distal orientation and a distal facing surface located along a circumferential region that surrounds the longitudinal axis;

a mechanical positioning assembly coupled to the first end of the housing to mechanically adjust the housing between the first and second conditions; and

an ablation element cooperating with the housing and which is adapted to ablatively couple to a circumferential area normal to the distal facing surface along the circumferential region when the housing is in the second position,

wherein the ablation element and distal facing surface are configured such that the circumferential area coincides with the circumferential region of tissue when the housing is adjusted to the second condition at the location, and wherein the housing farther comprises a proximal wall that in the second condition has a proximally facing surface, and the proximal wall is connected to the distal wall.

17. The system of claim 16, wherein the distal and proximal walls are formed from an integral member.

18. The system of claim 16, wherein

the distal wall in the second position further comprises an outer circumferential region that circumscribes the circumferential region that includes the distal facing surface, and also an inner circumferential region that is circumscribed by the circumferential region that includes the distal facing surface;

and

the distal and proximal walls are connected along at least one of the outer and inner circumferential regions.

19. The system of claim 16, wherein

the distal wall in the second position farther comprises an inner circumferential region that is circumscribed by the circumferential region that includes the distal facing surface;

and

the mechanical positioning assembly comprises at least one support member extending between the distal and proximal walls at least across the inner circumferential region and the circumferential region that includes the distal facing surface.

20. A tissue ablation system for treating atrial arrhythmia by ablating a circumferential region of tissue at a location where a pulmonary vein extends from an atrium, comprising:

a delivery member having a proximal end portion and a distal end portion with a longitudinal axis and a radial axis;

a cantilevered housing with a first end, a second end and a distal wall, that is located at least in part along the distal end portion, and that is adjustable between a first condition and a second condition, wherein the first condition the distal wall is substantially radially collapsed such that the housing is adapted to be delivered through a delivery sheath into the atrium, and wherein the second condition the second end and the distal wall are radially extended at least in part from the longitudinal axis, the distal wall having a distal orientation and a distal facing surface substantially perpendicular to the longitudinal axis and located along a circumferential region that surrounds the longitudinal axis;

a positioning assembly coupled to the housing to adjust the housing between the first and second conditions; and

an ablation element cooperating with the housing and which is adapted to ablatively couple to a circumferential area normal to the distal facing surface along the circumferential region when the housing is in the second position,

wherein the ablation element and distal facing surface are configured such that the circumferential area coincides with the circumferential region of tissue when the housing is adjusted to the second condition at the location.

21. A circumferential ablation member for ablating a circumferential region of tissue in a body lumen, comprising:

a cantilevered housing with a first end, a second end, and a distal wall, and that is adjustable between a first condition and a second condition about a longitudinal axis, wherein the first condition the distal wall is substantially radially collapsed such that the housing is adapted to be delivered through a delivery sheath into a body lumen, and wherein the second condition the second end and the distal wall are radially extended at least in part from the longitudinal axis, the distal wall having a distal orientation and a distal facing surface substantially perpendicular to the longitudinal axis and located along a circumferential path that surrounds the longitudinal axis; and

an ablation element cooperating with the housing and which is adapted to ablatively couple to a circumferential area normal to the distal facing surface along the circumferential path when the housing is in the second position, wherein the circumferential area is ablatively coupled with the circumferential region of tissue when the housing is adjusted to the second condition.