Systems and methods for making and using medical ablation systems having mapping catheters with improved anchoring ability

• US 9,480,521 B2
• Filed: 05/20/2014
• Issued: 11/01/2016
• Est. Priority Date: 08/14/2009
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: McGee, David, Kim, Isaac, Koblish, Josef V.
• Primary Examiner(s): Cohen, Lee S
• Application Number:
  US14/282,726
• Publication Number:
  US 20140257261A1
• Time in Patent Office: 896 Days
• Field of Search: 600/374, 600/381, 606/21, 606/41
• US Class Current: 1/1
• 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 2017/00053 Mapping
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2018/00166 Multiple lumina
• CPC Class Codes: A61B 2018/0022 Balloons
• 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 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00916 with means for switching or controlling the main function of the instrument or device
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/1407 Loop
• CPC Class Codes: A61B 5/0036 including treatment, e.g., using an implantable medical device, ablating, ventilating
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 5/6856 with a distal loop
• CPC Class Codes: A61B 5/6857 with a distal pigtail shape

Abstract

A mapping catheter includes an elongated body for inserting into patient vasculature. A distal end of the elongated body includes a distal portion that includes a plurality of electrodes, a proximal portion disposed proximal to the distal portion, and a reduced-dimension portion disposed between the proximal and distal portions. The distal end is formed, at least in part, from a memory shape material that bends into a preformed shape upon release from a confined space. The preformed shape includes a first loop formed, at least in part, by the distal portion. The first loop is transverse to a longitudinal axis of the proximal portion. The reduced-dimension portion is configured and arranged to bend such that the reduced-dimension section advances distally through the first loop when the first loop is held in a fixed position and a force is applied distally along the longitudinal axis of the proximal portion.

Claims

1. An ablation system comprising:

an ablation catheter having a distal portion and a proximal portion, the ablation catheter configured and arranged for insertion into patient vasculature;

an expansion element coupled to the distal portion of the ablation catheter, the expansion element configured and arranged for ablating patient tissue;

a coolant transfer tube disposed within the ablation catheter and in fluid communication with the expansion element;

a mapping catheter comprising an elongated body insertable through the ablation catheter and the expansion element, the elongated body comprising a distal end that is extendable from a distal end of the expansion element, the distal end of the elongated body comprising a distal portion including a plurality of electrodes and a proximal reduced-dimension portion adjacent the distal portion, the proximal reduced-dimension portion having a cross-sectional dimension that is less than corresponding cross-sectional dimensions of the distal portion, wherein the distal end of the elongated body is formed, at least in part, from a shape memory material that bends into a preformed shape upon release from a confined space, the preformed shape comprising a loop transverse to a longitudinal axis of the elongated body; and

a control module coupled to the ablation catheter and the mapping catheter, the control module configured and arranged for controlling mapping of electrical activity by the mapping catheter and ablation of patient tissue by the expansion element.

2. The ablation system of claim 1, wherein when the mapping catheter is extended distal of the expansion element, the distal end of the mapping catheter assumes its preformed loop shape, wherein the plurality of electrodes are disposed on the loop.

3. The ablation system of claim 2, wherein the mapping catheter has eight electrodes disposed on the loop.

4. The ablation system of claim 1, wherein the ablation catheter defines at least one coolant outtake region extending along at least a portion of the ablation catheter.

5. The ablation system of claim 1, wherein the preformed shape is a closed loop.

6. The ablation system of claim 1, wherein the control module includes one or more sensors for monitoring one or more conditions within the ablation catheter.

7. The ablation system of claim 1, wherein the expansion element includes an inner layer and an outer layer.

8. The ablation system of claim 1, wherein the distal portion of the elongated body is tapered.

9. The ablation system of claim 1, wherein the reduced-dimension portion is configured to be more flexible than the distal portion of the elongated body.

10. A method of ablating a pulmonary vein, the method comprising:

guiding an ablation catheter into proximity of an ostium of a pulmonary vein, the ablation catheter including an expansion element and a mapping catheter, the mapping catheter comprising an elongated body insertable through the ablation catheter and the expansion element, the elongated body comprising a distal end that is extendable from a distal end of the expansion element, the distal end of the elongated body comprising a distal portion including plurality of electrodes and a proximal reduced-dimension portion adjacent the distal portion, wherein the distal end of the elongated body is formed, at least in part, from a shape memory material that bends into a preformed shape upon release from a confined space, the preformed shape comprising a loop transverse to a longitudinal axis of the elongated body;

extending the mapping catheter through the distal end of the expansion element and allowing the distal end of the elongated body to form its preformed loop shape;

placing the loop shaped distal end of the mapping catheter into contact with the pulmonary vein and mapping electrical activity within walls of the pulmonary vein with the electrodes, wherein at least a portion of the proximal reduced-dimension portion extends through the loop shaped distal end;

inputting coolant into contact with the expansion element to expand the coolant;

in response to coolant expansion, expanding the expansion element;

advancing the expanded expansion element into contact with the ostium of the pulmonary vein; and

cryoablating the pulmonary vein ostium with the expansion element.

11. The method of claim 10, wherein the mapping catheter distal end forms a closed loop upon being extended from the expansion element.

12. The method of claim 10, wherein the ablation catheter defines at least one coolant outtake region extending along at least a portion of the ablation catheter, and the steps of expanding the expansion element and ablating include flowing coolant into the expansion element and withdrawing coolant from the coolant outtake region such that the expansion element expands and freezes tissue in contact with an outer surface of the expansion element.

13. The method of claim 12, wherein the ablation catheter includes one or more sensors for monitoring one or more conditions within the ablation catheter, wherein ablating includes monitoring the one or more conditions and adjusting the flow of coolant in response to the one or more conditions.

14. The method of claim 10, further comprising mapping electrical activity within the walls of the pulmonary vein after the ablation step.

15. The method of claim 10, wherein the ablation catheter includes a control module, the control module controlling the mapping of electrical activity by the mapping catheter and flow of coolant into and out of the expansion element to control ablation of patient issue by the expansion element.

16. The method of claim 10, wherein the reduced-dimension portion has a cross-sectional dimension that is less than corresponding cross-sectional dimensions of the distal portion.

17. The method of claim 10, wherein the reduced-dimension portion bends while extending through the loop shaped distal end.