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

• US 6,966,908 B2
• Filed: 10/21/2002
• Issued: 11/22/2005
• Est. Priority Date: 07/08/1997
• Status: Expired due to Term

• Current Assignee: Atrionix, Inc. (Johnson & Johnson)
• Original Assignee: Atrionix, Inc. (Johnson & Johnson)
• Inventors: Lesh, Michael D., Peacock, James C. III, Maguire, Mark A., Carcamo, Edward L.
• Primary Examiner(s): Gibson, Roy D.
• Application Number:
  US10/274,767
• Publication Number:
  US 20030050637A1
• Time in Patent Office: 1,128 Days
• Field of Search: 606/41, 607/99, 607/101, 607/102, 607/113, 607/122, 600/374, 600/393
• US Class Current: 606/41
• 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 18/1815 using microwaves
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• 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 2018/0016 Energy applicators arranged in a two- or three dimensional array
• 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 2018/00273 Anchoring means for temporary attachment of a device to tissue
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00369 Heart valves
• CPC Class Codes: A61B 2018/00375 : Ostium, e.g. ostium of pulmonary vein or artery
• CPC Class Codes: A61B 2018/00797 : measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00815 : measured by a thermistor
• CPC Class Codes: A61B 2018/00821 : measured by a thermocouple
• CPC Class Codes: A61B 2018/00839 : Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/00898 : Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/00994 : combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound
• 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 with a proximal end portion and a distal end portion with a longitudinal axis and a radial axis;

a circumferential ablation member cooperating with the delivery member, the delivery member being adapted to at least in-part deliver the circumferential ablation member to the location, the circumferential ablation member having,

a circumferential support member that is adjustable between a first position which is adapted to be delivered through a delivery sheath into the atrium and a second position having a substantially circumferentially looped shape, the circumferential support member comprising an elongate body which in the first position has a substantially straight shape relative to the longitudinal axis with a proximal end secured to the distal end portion, a distal end extending away from the distal end portion substantially along the longitudinal axis, and an intermediate region extending between the proximal and distal ends, wherein in the second position the elongate body is adjusted to the substantially circumferentially looped shape,

an ablation element located substantially along the circumferential support member and that is adapted to ablatively couple to a circumferential area adjacent to the support member in the second position, and

a positioning means coupled to the circumferential support member to adjust the circumferential support member between the first and second positions when the circumferential support member is substantially unconfined within the atrium, wherein the ablation element and the circumferential support member are configured such that the circumferential area coincides with the circumferential region of tissue when the circumferential support member is adjusted to the second position at the location.

2. The system of claim 1, wherein

the delivery member has a passageway extending between a distal port adjacent the proximal end of the elongate body and a proximal port located along the proximal end portion of the delivery member;

the positioning means comprises a pull-wire with a proximal end portion and a distal end portion;

the pull-wire is moveably engaged within the passageway such that the proximal end portion of the pull-wire extending proximally through the proximal port, the distal end portion of the pull-wire extends distally through the distal port;

the distal end portion of the pull-wire is secured to the distal end of the elongate body;

in the first position the first and second ends of the elongate body are spaced along the pull-wire with the intermediate region of the elongate body extending along the longitudinal axis adjacent to the pull-wire; and

the circumferential support member is adjustable to the second position at least in part by adjusting the relative position of the pull-wire with respect to its moveable engagement within the passageway of the delivery member such that the proximal and distal ends of the elongate body are longitudinally collapsed toward each other and the intermediate region is radially deflected to form at least in part the substantially looped shape between the longitudinally collapsed ends.

3. The system of claim 2, wherein the intermediate region is constructed with a predisposed bias toward the substantially looped geometry.

4. The system of claim 2, further comprising at least one indicator that indicates when the circumferential ablation member is in the second position.

5. The system of claim 4, wherein said at least one indicator comprises a first radiopaque marker at a first location corresponding to the proximal end of the elongate body and a second radiopaque marker at a second location corresponding to the distal end of the elongate body, wherein the relative locations of the first and second radiopaque markers indicate the relative location of the proximal and distal end portions of the elongate body.

6. The system of claim 4, wherein said at least one indicator comprises a first visible indicator located along the proximal end portion of the delivery member and a second visible indicator coupled to the proximal end portion of the pull-wire.

7. The system of claim 1, wherein

the delivery assembly comprises first and second delivery members each having a proximal end portion and a distal end portion;

the circumferential support member comprises an elongate body with a distal end secured to the distal end portion of the first delivery member and a proximal end secured to the distal end portion of the second delivery member;

the positioning means comprises an outer member with a proximal end portion and a distal end portion that surrounds the distal end portions of the first and second delivery members and that has a longitudinal axis,

wherein the distal end portion of at least one of the delivery members is longitudinally moveable within the outer member such that in the first position the distal end portions of the first and second delivery members are positioned relative to each other such that the elongate body extends distally from the first delivery member substantially along the longitudinal axis, and wherein in the second position the distal end portions of the first and second delivery members are longitudinally adjusted relative to each other and also relative to the outer member such that the elongate body is positioned externally of the distal end portion of the outer member with the proximal end of the elongate body adjacent to the distal end of the elongate body, such that the elongate body between the proximal and distal ends is adjusted into the substantially circumferentially looped shape.

8. The system of claim 7, wherein the first delivery member is adapted to be positioned within the pulmonary vein, and further comprising an anchor along the distal end portion of the first delivery member and which is adapted to secure the first delivery member within the pulmonary vein.

9. The system of claim 8, wherein the anchor comprises an expandable member which is adapted to expand to radially engage the pulmonary vein in order to secure the first delivery member.

10. The system of claim 1, wherein

the delivery assembly comprises a delivery member with a proximal end portion and a distal end portion with a longitudinal axis and a radial axis;

and

the positioning means comprises an array of circumferentially spaced splines that are positioned around the longitudinal axis, each spline having proximal end portion coupled to the distal end portion of the delivery member and a distal end portion coupled to the circumferential support member, and each spline being adjustable between a first configuration wherein the distal end portion of the spline extends substantially along the longitudinal axis and a second configuration wherein the distal end portion of the spline extends radially away from the longitudinal axis,

such that the first position for the circumferential support member is characterized at least in part by each of the splines being adjusted to the first configuration, and the second position for the circumferential support member is characterized at least in part by each spline being adjusted to the second configuration.

11. The system of claim 10, wherein each spline comprises a single elongate member that terminates along the distal end portion of the spline at the coupling to the circumferential support member.

12. The system of claim 10, wherein each spline comprises a looped member having an apex along the distal end portion of the spline and two legs extending proximally from the apex along the proximal end portion of the spline.

13. The system of claim 12, wherein the circumferential support member is threaded through the apices of the circumferentially spaced splines.

14. The system of claim 10, wherein the system is adapted to cooperate with an ablation actuator, and:

at least one spline is adapted to couple at least in part the ablation element to the ablation actuator.

15. The system of claim 14, further comprising:

a proximal coupler located along the proximal end portion of the delivery member and which is adapted to couple to the ablation actuator; and

an ablation actuating member which extends between the proximal coupler and the ablation element along the at least one spline.

16. The system of claim 15, wherein

the ablation element comprises a fluid ablation element;

the proximal coupler comprises a fluid coupler that is adapted to couple to a fluid source; and

the ablation actuating member comprises a tubular member with a passageway that fluidly couples the ablation element with a fluid source coupled to the proximal coupler.

17. The system of claim 15, wherein

the ablation element comprises an electrical current ablation element;

the proximal coupler is adapted to couple to an electrical current source; and

the ablation actuating member comprises an electrical conductor lead that electrically couples the electrical current ablation element with a electrical current source coupled to the proximal coupler.

18. The system of claim 10, wherein the ablation element comprises a plurality of individual ablation elements, wherein each individual ablation element extends along the circumferential support member between two adjacent splines.

19. The system of claim 10, wherein each of the splines comprises a material having a memory to the second configuration.

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 circumferential ablation member having a circumferential support member that is adjustable between a first position which is adapted to be delivered through a delivery sheath into the atrium and a second position having a substantially circumferentially looped shape, an electrical current ablation element located substantially along the circumferential support member and that is adapted to ablatively couple to a circumferential area adjacent to the support member in the second position, and a positioning assembly coupled to the circumferential support member to adjust the circumferential support member between the first and second positions when the circumferential support member is substantially unconfined within the atrium; and

a delivery assembly cooperating with the circumferential ablation member and which is adapted to at least in-part deliver the circumferential ablation member to the location, wherein the electric current ablation element and the circumferential support member are configured such that the circumferential area coincides with the circumferential region of tissue when the circumferential support member is adjusted to the second position at the location;

wherein the electrical current ablation element comprises at least one electrode along the circumferential support member which is adapted to be coupled to an electrical current source, and a porous wall that substantially surrounds the electrode within an enclosed fluid chamber which and is adapted to be fluidly coupled to a source of electrically conductive fluid, wherein the porous wall is adapted to electrically couple an ablative electrical current between the circumferential region of tissue positioned coincident to the circumferential area and the electrode via the electrically conductive fluid.