Ablation Catheters and Associated Systems and Methods

• US 20120310239A1
• Filed: 07/27/2012
• Published: 12/06/2012
• Est. Priority Date: 04/05/1999
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Stewart, Mark T., Skarda, James
• Granted Patent: US 8,834,464 B2
• Time in Patent Office: Days
• US Class Current: 606/41
• 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 2017/00044 Sensing electrocardiography, i.e. ECG
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• 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 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00375 Ostium, e.g. ostium of pulmonary vein or artery
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00898 Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/1407 Loop
• CPC Class Codes: A61B 2018/1435 Spiral
• CPC Class Codes: A61B 2018/1472 for use with liquid electrolyte, e.g. virtual electrodes

Abstract

An ablation catheter assembly includes an elongate catheter body having a proximal portion, a distal portion and a lumen therethrough. A helical structure associated with the catheter distal portion carries a plurality of independently operable electrodes and is transformable between a low-profile configuration wherein a straightening element is positioned in the lumen and an expanded configuration wherein the straightening element is at least partially retracted from the spiral structure. When the helical structure is in the expanded configuration, a laterally offset tip portion extends distally therefrom.

Claims

1. A catheter assembly, comprising:

an elongated body having a proximal portion and a distal portion, wherein the distal portion of the body is configured for intravascular delivery to a body lumen of a human patient;

a pre-shaped spiral structure associated with the distal portion of the elongated body, wherein the spiral structure comprises a flexible, curved distal tip portion, and wherein the elongated body and the pre-shaped spiral structure comprise a central lumen; and

a plurality of electrodes associated with the spiral structure,

wherein the pre-shaped spiral structure is transformable between—

a low-profile configuration wherein a straightening element is positioned in the central lumen; and

an expanded configuration wherein the straightening element is at least partially retracted from the spiral structure toward the proximal portion of the elongated body,

wherein, in the expanded configuration, the distal tip portion of the spiral structure extends coaxially from a distalmost portion of the spiral structure and is laterally offset from a longitudinal axis of the elongated body.

2. The catheter assembly of claim 1 wherein the straightening element comprises a stylet, and wherein:

the central lumen is configured to slidably receive the stylet to locate the spiral structure at a target treatment site within the body lumen of the patient with the spiral structure in the low-profile configuration, and

proximal retraction of the stylet through the central lumen relative to the spiral structure such that a distal end portion of the stylet is within the central lumen and aligned with or proximal of the spiral structure places the spiral structure in the expanded configuration.

3. The catheter assembly of claim 1 wherein the straightening element comprises a procedural guide wire, and wherein:

the central lumen is configured to slidably receive the procedural guide wire to locate the spiral structure at a target treatment site within the body lumen of the patient with the spiral structure in the low-profile configuration, and

proximal retraction of the procedural guide wire through the central lumen relative to the spiral structure such that a distal end portion of the guide wire is within the central lumen and aligned with or proximal of the spiral structure places the spiral structure in the expanded configuration.

4. The catheter assembly of claim 1 wherein the spiral structure is composed, at least in part, of a shape memory material.

5. The catheter assembly of claim 1, further comprising an energy source operably coupled to the electrodes, and wherein, upon activation by the energy source, one or more of the electrodes are configured to ablate a desired lesion pattern in the body lumen.

6. The catheter assembly of claim 1 wherein the electrodes comprise a series of band electrodes disposed along a portion of the spiral structure.

7. The catheter assembly of claim 1 wherein the electrodes are electrically isolated from one another.

8. The catheter assembly of claim 1 wherein at least some of the electrodes are electrically connected to one another.

9. The catheter assembly of claim 1 wherein each of the electrodes further comprises a thermocouple.

10. The catheter assembly of claim 1, further comprising a fluid source configured to deliver a fluid to cool the electrodes carried by the spiral structure during operation.

11. The catheter assembly of claim 1, further comprising a fluid source configured to deliver fluid to the central lumen at the spiral structure and cool the electrodes carried by the spiral structure when the spiral structure is in the expanded configuration.

12. The catheter assembly of claim 1 wherein:

the spiral structure is composed, at least in part, of a shape memory material;

the straightening element comprises a procedural guide wire, and wherein—

the central lumen is configured to slidably receive the procedural guide wire to locate the spiral structure at a target treatment site within the body lumen of the patient with the spiral structure in the low-profile configuration, and

proximal retraction of the procedural guide wire through the central lumen relative to the spiral structure such that a distal end portion of the guide wire is within the central lumen and aligned with or proximal of the spiral structure places the spiral structure in the expanded configuration;

the distal tip portion and the spiral structure are composed of different materials; and

the electrodes comprise a series of band electrodes disposed along a portion of the spiral structure, and wherein each of the electrodes comprises a thermocouple.

13. A catheter assembly, comprising:

a catheter body including a proximal portion, a distal portion, and a lumen therethrough;

a helical structure associated with the distal portion of the catheter body, wherein the helical structure comprises a flexible, curved distal tip; and

a plurality of energy delivery elements carried by the helical structure,

wherein the helical structure is selectively transformable between—

a delivery state wherein a stylet is positioned in the lumen at the distal portion of the catheter body and the helical structure is generally straightened for delivery to a target treatment site in a body lumen; and

an expanded state wherein the stylet is at least partially retracted from the distal portion of the catheter body and the helical structure is configured to position the energy delivery elements in stable contact with a wall of the body lumen at the target treatment site, and wherein, in the expanded state, the distal tip is offset from a longitudinal axis of the catheter body and at least partially engaged with a wall of the body lumen.

14. The catheter assembly of claim 13 wherein the helical structure is composed of a shape memory material that biases the helical structure to the expanded state.

15. The catheter assembly of claim 13 wherein the tip and the helical structure are composed of different materials.

16. The catheter assembly of claim 13 wherein the tip does not include any energy delivery elements.

17. The catheter assembly of claim 13 wherein the energy delivery elements comprise a plurality of independently operable band electrodes disposed along the helical structure.

18. The catheter assembly of claim 17 wherein the band electrodes are arranged on the helical structure to form a pattern of discrete, non-continuous lesions at the target treatment site when the helical structure is in the expanded state.

19. The catheter assembly of claim 13, further comprising a retractable sheath at least partially surrounding the distal portion of the catheter body when the helical structure is in the delivery state.

20. The catheter assembly of claim 13 wherein the elongated body is configured for over-the-wire or rapid exchange delivery techniques.

21. The catheter assembly of claim 13 wherein the helical structure comprises a generally uniform diameter in the expanded state.

22. A catheter assembly, comprising:

a catheter body having a proximal region, a distal region, and a central lumen extending at least partially therethrough;

a treatment section at the distal region of the catheter body, wherein the treatment section comprises a coil composed of a shape memory material and having a plurality of loop segments arranged about a central loop axis, wherein the central loop axis is generally parallel with a longitudinal axis of the catheter body; and

a plurality of independently operable electrodes disposed along a portion of the treatment section,

wherein axial movement of a stylet disposed in the central lumen relative to the treatment section places the treatment section in one of (a) a low-profile delivery configuration wherein the treatment section comprises a generally straight shape, and (b) a deployed configuration wherein the treatment section comprises a coiled shape and the plurality of loop segments are longitudinally spaced apart along the central loop axis,

wherein a distal tip of the treatment section extends coaxially from a distalmost loop segment and is laterally offset from the central loop axis and the longitudinal axis when the treatment section is in the deployed configuration.