Circumferential ablation device assembly with dual expandable members

• US 20050165388A1
• Filed: 12/23/2004
• Published: 07/28/2005
• Est. Priority Date: 12/31/2003
• Status: Active Grant

• Current Assignee: Biosense Webster Incorporated (Johnson & Johnson)
• Original Assignee: Biosense Webster Incorporated (Johnson & Johnson)
• Inventors: Bhola, Sumita
• Granted Patent: US 7,655,005 B2
• Time in Patent Office: Days
• US Class Current: 606/14
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2018/00065 porous
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00261 arranged in a line
• CPC Class Codes: A61B 2018/00375 Ostium, e.g. ostium of pulmonary vein or artery
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/1861 with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

The present invention involves a surgical device and method of use, particularly an assembly and method incorporating dual expandable members along the distal region of an ablation device to facilitate ablation of a circumferential region of tissue engaged by the expandable member. The ablation device assembly includes an elongate body with a proximal end portion, a distal end portion, and a longitudinal axis. A first expansion element is located along the distal end portion of the elongate body, and is fluidly coupled to a first source of inflation fluid. A second expansion element having a circumferential wall is located along the distal end portion proximal the first expansion element, and is fluidly coupled to a second source of inflation fluid. An ablation element having an ablative energy source is located along the distal end portion within the second expansion element, wherein the ablation element cooperates with the second expansion element such that the ablative energy source emits a substantially circumferential pattern of energy through the circumferential wall.

Claims

1. An ablation device assembly for ablating a circumferential region of tissue at a location within a body space where a pulmonary vein extends from an atrium, comprising:

an elongate body with a proximal end portion, a distal end portion, and a longitudinal axis;

a first expansion element located along the distal end portion, the first expansion element being fluidly coupled to a first source of inflation fluid, and expandable from a radially collapsed condition to a radially expanded condition;

a second expansion element located along the distal end portion proximal the first expansion element, the second expansion element being fluidly coupled to a second source of inflation fluid, and having a circumferential wall and being expandable from a radially collapsed condition to a radially expanded condition; and

an ablation element having an ablative energy source that is located along the distal end portion within the second expansion element, wherein the ablation element cooperates with the second expansion element such that the ablative energy source emits a substantially circumferential pattern of energy through the circumferential wall.

2. The assembly of claim 1, wherein the second expansion elements comprise an inflatable balloon, the circumferential wall comprises an outer skin of the balloon, and the ablative energy source is adapted to emit the circumferential pattern of energy through the outer skin of the balloon and into the circumferential region of tissue.

3. The assembly of claim 1, wherein the ablation element comprises a thermal ablation element.

4. The assembly of claim 1, wherein the ablation element comprises an ultrasound ablation element.

5. The assembly of claim 1, wherein the ablation element comprises a microwave ablation element.

6. The assembly of claim 1, wherein the ablation element comprises a cryoablation element.

7. The assembly of claim 1, wherein the ablation element comprises a fluid delivery element.

8. The assembly of claim 1, wherein the ablation element comprises a light emitting ablation element.

9. The assembly of claim 1 wherein in the radially expanded condition, the second expansion element comprises first and second end portions and an intermediate region extending between the first and second end portions relative to the longitudinal axis, 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 being 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.

10. The assembly of claim 9, wherein the intermediate region comprises a material having 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.

11. The assembly of claim 9, wherein the intermediate region comprises a porous material having 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 apertures.

12. The assembly of claim 9, wherein the intermediate region comprises a porous fluoropolymer material.

13. 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.

14. The assembly of claim 13, 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.

15. The assembly of claim 1, wherein the second expansion element further comprises a shaped balloon that includes a balloon skin that forms the chamber and which is inflatable with an inflation medium in order to expand from the radially collapsed condition to the radially expanded condition.

16. The assembly of claim 15, wherein the balloon is constructed from the group of materials consisting of polyurethane, silicone, mylar, latex, and combinations and blends thereof.

17. The assembly of claim 15, wherein the balloon exhibits at least about a 400% elastic expansion before yield.

18. The assembly of claim 15, wherein the balloon has a profile in the radially collapsed condition which is between about 0.091 and 0.156 inches, inclusive, and the expanded outer diameter is between about 1.0 and 2.5 centimeters, also inclusive.

19. The assembly of claim 1, wherein the elongate body further comprises:

a first fluid passageway extending between a first proximal port, which is located along the proximal end portion and is adapted to couple to the first source of inflation fluid, and a first distal port, which is located along the distal end portion and through which the fluid passageway is fluidly coupled to the first expansion element; and

a second fluid passageway extending between a second proximal port, which is located along the proximal end portion and is adapted to couple to the second source of inflation fluid, and a second distal port, which is located along the distal end portion and through which the fluid passageway is fluidly coupled to the second expansion element.

20. The assembly of claim 1, further comprising:

a first expansion actuator that is adapted to expand the first expandable element from the radially collapsed condition to the radially expanded condition; and

a second expansion actuator that is adapted to expand the second expandable element from the radially collapsed condition to the radially expanded condition.

21. An ablation device assembly for ablating a circumferential region of tissue at a location within a body space where a pulmonary vein extends from an atrium, comprising:

an elongate body with a proximal end portion, a distal end portion, and a longitudinal axis;

a first expansion element having a first wall thickness, located along the distal end portion, the first expansion element being fluidly coupled to a source of inflation fluid, and expandable from a radially collapsed condition to a radially expanded condition;

a second expansion element having a second wall thickness located along the distal end portion proximal the first expansion element, the second expansion element being fluidly coupled to the source of inflation fluid, and being expandable from a radially collapsed condition to a radially expanded condition, wherein the first wall thickness of the first expansion element is smaller than the second wall thickness of the second expansion element; and

an ablation element having an ablative energy source that is located along the distal end portion within the second expansion element, wherein the ablation element cooperates with the second expansion element such that the ablative energy source emits a substantially circumferential pattern of energy through the second expansion element.

22. An ablation device assembly for ablating a circumferential region of tissue at a location within a body space where a pulmonary vein extends from an atrium, comprising:

an elongate body with a proximal end portion, a distal end portion, and a longitudinal axis;

a first expansion element located along the distal end portion, the first expansion element being fluidly coupled to a source of inflation fluid, and expandable from a radially collapsed condition to a radially expanded condition;

a second expansion element located along the distal end portion proximal the first expansion element, the second expansion element being fluidly coupled to the source of inflation fluid, and being expandable from a radially collapsed condition to a radially expanded condition, wherein first expansion element is more compliant that the second expansion element; and

an ablation element having an ablative energy source that is located along the distal end portion within the second expansion element, wherein the ablation element cooperates with the second expansion element such that the ablative energy source emits a substantially circumferential pattern of energy through the second expansion element.

23. 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, the circumferential ablation member being adjustable from a first condition to a second condition, and including first and second expansion elements, wherein the first expansion element is fluidly coupled to a first source of inflation fluid and the second expansion element is fluidly coupled to a second source of inflation fluid; and

a steerable delivery member with a proximal end portion and a distal end portion that 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 when the circumferential ablation member is in the first condition.