SYSTEMS AND METHODS FOR MAKING AND USING MEDICAL ABLATION SYSTEMS AND HAVING MAPPING CATHETERS WITH IMPROVED ANCHORING ABILITY

• US 20110040167A1
• Filed: 08/11/2010
• Published: 02/17/2011
• 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: KIM, ISAAC, MCGEE, DAVID, KOBLISH, JOSEF
• Granted Patent: US 8,380,275 B2
• Time in Patent Office: Days
• US Class Current: 600/373
• 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. A mapping catheter comprising:

an elongated body configured and arranged for insertion into patient vasculature, wherein a

distal end of the elongated body comprises;

a distal portion comprising a plurality of electrodes,

a proximal portion disposed proximal to the distal portion, and

a reduced-dimension portion disposed between the proximal portion and the distal portion, the reduced-dimension portion having a cross-sectional dimension that is less than corresponding cross-sectional dimensions of both a proximally-positioned adjacent section of the distal portion and a distally-positioned adjacent section of the proximal portion;

wherein 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 comprising a first loop formed, at least in part, by the distal portion, wherein the first loop is transverse to a longitudinal axis of the proximal portion,

wherein 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 along the longitudinal axis of the proximal portion in a distal direction.

2. The mapping catheter of claim 1, wherein the distal portion of the mapping catheter tapers in a distal direction.

3. The mapping catheter of claim 1, wherein the reduced-dimension portion of the mapping catheter tapers in a proximal direction.

4. The mapping catheter of claim 1, wherein the reduced-dimension portion is configured and arranged to bend preferentially in a dimension such that the proximally-positioned adjacent section to the reduced-dimension portion advances distally through the first loop when the first loop is held in a fixed position and a force is applied along the axis of the proximal portion in a distal direction.

5. The mapping catheter of claim 1, wherein the preformed shape comprises a second loop formed, at least in part, by the reduced-dimension portion.

6. The mapping catheter of claim 5, wherein the first loop and the second loop are parallel.

7. The mapping catheter of claim 5, wherein the first loop has a transverse diameter that is larger than a transverse diameter of the second loop.

8. The mapping catheter of claim 1, wherein the reduced-dimension portion is disposed proximal to the plurality of electrodes.

9. The mapping catheter of claim 1, wherein the reduced-dimension portion has a transverse cross-sectional shape that is round.

10. The mapping catheter of claim 1, wherein the reduced-dimension portion has a transverse cross-sectional shape that is rectangular and comprises a first dimension and a second dimension that is perpendicular to the first dimension and that is no larger than the first dimension.

11. The mapping catheter of claim 10, wherein the first dimension of the reduced-dimension portion is no more than ten times larger than the second dimension.

12. The mapping catheter of claim 10, wherein the second dimension of the reduced-dimension portion is smaller than a largest transverse cross-sectional dimension of the distal portion.

13. The mapping catheter of claim 1, wherein the first loop comprises at least one full circle.

14. The mapping catheter of claim 1, further comprising at least one electrode disposed on the reduced-dimension portion.

15. An ablation system comprising:

an ablation catheter having a distal portion, a proximal portion, and a longitudinal length, the ablation catheter configured and arranged for insertion into patient vasculature, the ablation catheter comprising a body and defining at least one coolant outtake region extending along at least a portion of the ablation catheter;

a guide tube at least partially disposed in the ablation catheter;

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

a mapping catheter comprising an elongated body insertable into the guide tube, the elongated body comprising a distal end that is extendable from a distal end of the guide tube, the distal end of the elongated body comprising;

a distal portion comprising a plurality of electrodes,

a proximal portion disposed proximal to the distal portion, and

a reduced-dimension portion disposed between the proximal portion and the distal portion, the reduced-dimension portion having a cross-sectional dimension that is less than corresponding cross-sectional dimensions of both a proximally-positioned adjacent section of the distal portion and a distally-positioned adjacent section of the proximal portion;

wherein 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 comprising a first loop formed, at least in part, by the distal portion, wherein the first loop is transverse to a longitudinal axis of the proximal portion,

wherein 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 along the longitudinal axis of the proximal portion in a distal direction; and

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

16. The ablation catheter of claim 15, wherein the ablation system is one of a cryoablation system or a radio frequency ablation system.

17. A method of mapping a pulmonary vein, the method comprising:

guiding a mapping catheter in proximity to an ostium of a pulmonary vein, the mapping catheter comprising an elongated body with a distal end formed, at least in part, from a memory shape material that bends into a preformed shape upon release from a confined space, the distal end of the elongated body comprising;

a distal portion comprising a plurality of electrodes,

a proximal portion disposed proximal to the distal portion, and

a reduced-dimension portion disposed between the proximal portion and the distal portion, the reduced-dimension portion having a cross-sectional dimension that is less than corresponding cross-sectional dimensions of both a proximally-positioned adjacent section of the distal portion and a distally-positioned adjacent section of the proximal portion,

wherein the preformed shape comprises a first loop formed, at least in part, by the distal portion, wherein the first loop is transverse to a longitudinal axis of the proximal portion, inserting the mapping catheter into the pulmonary vein such that the first loop abuts inner walls of the pulmonary vein;

providing a force distally along the axis of the proximal portion sufficient to cause the reduced-dimension portion to preferentially bend such that the reduced-dimension portion advances distally through the first loop; and

mapping electrical activity within walls of the pulmonary vein using a plurality of mapping electrodes disposed along the first loop.

18. The method of claim 17, wherein guiding the mapping catheter in proximity to the ostium of the pulmonary vein, the mapping catheter comprising an elongated body with a distal end formed, at least in part, from a memory shape material that bends into a preformed shape upon release from a confined space comprises releasing the mapping catheter from a lumen of an ablation catheter.

19. The method of claim 17, wherein providing force distally along the axis of the proximal portion sufficient to cause the reduced-dimension portion to preferentially bend such that the reduced-dimension portion advances distally through the first loop comprises providing force distally along the axis of the proximal portion sufficient to cause at least a portion of the reduced-dimension portion to abut the walls of the pulmonary vein.

20. The method of claim 19, wherein providing force distally along the axis of the proximal portion sufficient to cause at least a portion of the reduced-dimension portion to abut the walls of the pulmonary vein comprises the reduced-dimension portion being bent to form a second loop.