Map and ablate open irrigated hybrid catheter

• US 9,393,072 B2
• Filed: 06/03/2014
• Issued: 07/19/2016
• Est. Priority Date: 06/30/2009
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Kim, Isaac J., Koblish, Josef V., Velilla, Simplicio A., Mirigian, Mark D.
• Primary Examiner(s): Stoklosa, Joseph
• Assistant Examiner(s): ANTISKAY, BRIAN MICHAEL
• Application Number:
  US14/295,089
• Publication Number:
  US 20140288548A1
• Time in Patent Office: 777 Days
• Field of Search: 600372-374, 600/393, 600/466, 600/474, 606 20- 23, 606 32- 33, 606/41
• US Class Current: 1/1
• 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 2017/00044 Sensing electrocardiography, i.e. ECG
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00589 Coagulation
• CPC Class Codes: A61B 2018/00773 Sensed parameters
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/7217 of noise originating from a therapeutic or surgical apparatus, e.g. from a pacemaker
• CPC Class Codes: Y10T 29/49002 Electrical device making
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

An embodiment of an open-irrigated catheter system comprises a tip section, a distal insert, and mapping electrodes. The tip section has an exterior wall that defines an open interior region within the tip section. The exterior wall includes mapping electrode openings and irrigation ports. The exterior wall is conductive for delivering radio frequency (RF) energy for an RF ablation procedure. The irrigation ports are in fluid communication with the open interior region to allow fluid to flow from the open interior region through the irrigation ports. The distal insert is positioned within the tip section to separate the open region into a distal fluid reservoir and a proximal fluid reservoir. The mapping electrodes are positioned in the mapping electrode openings in the tip section.

Claims

1. An open-irrigated catheter system for performing mapping and ablation functions, comprising:

a tip section having an exterior wall that defines an open interior region within the tip section, wherein the exterior wall includes a plurality of mapping electrode openings, wherein at least one of the mapping electrode openings is spaced apart from a distal end of the exterior wall of the tip section, wherein the exterior wall includes at least one irrigation port in fluid communication with the open interior, and wherein the exterior wall is conductive for delivering radio frequency (RF) energy for an RF ablation procedure;

a distal insert positioned within the tip section separating the open interior region into a distal fluid reservoir and a proximal fluid reservoir;

a fluid path extending through the open interior region and in fluid communication with the distal fluid reservoir, the proximal fluid reservoir, and at least one irrigation port;

a plurality of mapping electrodes seated in the distal insert and aligned with the mapping electrode openings in the tip section;

wherein the distal insert has a peripheral surface with openings therein sized to receive at least one insulating element, wherein the distal insert includes at least one insulating element electrically insulating the mapping electrodes from the fluid path, the at least one insulating element including at least one insulated channel configured to electrically insulated wires extending from the plurality of mapping electrodes from the fluid path.

2. The system of claim 1, wherein each mapping electrode has a peripheral surface extending transverse to a longitudinal axis of the tip section, an inner surface facing the open interior region, and an outer surface facing laterally away from the tip section, wherein each insulating element covers the peripheral surface and the inner surface of its corresponding mapping electrode.

3. The system of claim 1, wherein the distal insert defines a fluid conduit extending from the distal fluid reservoir to the proximal fluid reservoir.

4. The system of claim 1, wherein the at least one irrigation port in fluid communication with the open interior region includes at least one distal irrigation port in fluid communication with the distal fluid reservoir.

5. The system of claim 1, wherein the at least one irrigation port in fluid communication with the open interior region includes at least one proximal irrigation port in fluid communication with the proximal fluid reservoir.

6. The system of claim 1, wherein the at least one irrigation port in fluid communication with the open interior region includes at least one distal irrigation port in fluid communication with the distal fluid reservoir and at least one proximal irrigation port in fluid communication with the proximal fluid reservoir.

7. The system of claim 1, further comprising a fluid cooling lumen extending through the distal insert to deliver fluid to the distal fluid reservoir, the fluid cooling lumen having a wall with openings therein to deliver fluid to the proximal fluid reservoir.

8. The system of claim 1, wherein:

the tip section includes a proximal section and a distal section, the proximal section including a distal side, and the distal section including a proximal side;

the distal insert includes a proximal lip on a proximal end of the distal insert and a distal lip on a distal end of the distal insert;

the proximal side of the distal section fits over the distal lip; and

the distal side of the proximal section fits over the proximal lip.

9. The system of claim 8, wherein the distal insert includes a middle portion between the proximal and distal lips, the middle portion having an outer surface substantially flush with an outer surface of the proximal section and with an outer surface of the distal section.

10. The system of claim 1, wherein:

the at least one irrigation port is separated from the distal end of the exterior wall of the tip section by a predetermined distance; and

the distal insert includes a distally-extending member terminating in a distal channel end, wherein the distally-extending member is configured with a first predetermined length to position the distal insert in the tip section on a proximal side of the at least one irrigation port when the distal channel end of the distally-extending member abuts the distal end of the exterior wall.

11. The system of claim 1, wherein:

the at least one irrigation port is separated from the distal end of the exterior wall of the tip section by a predetermined distance;

the distal insert includes a main body portion and at least one of the insulated channel extending from a proximal channel end through the main body portion to a distal channel end, the main body portion having a circumference generally complementary to an inner diameter of the exterior wall;

the distal channel end abuts a distal wall of the tip section, the main body is positioned on a proximal side of the at least one irrigation port, and the proximal channel end is connected to a proximally adjacent structure;

the insulated channel has an interior passage that is isolated insulated from the proximal fluid reservoir; and

the system includes wires extending through the interior passage of the insulated channel into the main body portion of the distal insert to the mapping electrodes.

12. The system of claim 1, further comprising a thermocouple.

13. The system of claim 1, wherein the at least one insulating element has a generally annular shape.

14. The system of claim 1, wherein the mapping electrodes include three mapping electrodes approximately equally spaced from each other about a circumference of the tip section.

15. The system of claim 1, wherein the mapping electrodes include four mapping electrodes approximately equally spaced from each other spaced about a circumference of the tip section.

16. An open-irrigated catheter system for performing mapping and ablation functions, comprising:

a tip section having an exterior wall that defines an open interior region within the tip section, wherein the exterior wall includes a plurality of mapping electrode openings in fluid communication with the open interior, wherein at least one of the mapping electrode openings is spaced apart from a distal end of the exterior wall of the tip section, wherein the exterior wall includes at least one irrigation port in fluid communication with the open interior region and wherein the exterior wall is conductive for delivering radio frequency (RF) energy for an RF ablation procedure;

a distal insert within the tip section separating the open interior region into a distal fluid reservoir and a proximal fluid reservoir;

a fluid path extending through the tip section and in fluid communication with the at least one irrigation port;

a plurality of mapping electrodes seated in the distal insert and in alignment with the mapping electrode openings in the tip section, wherein each mapping electrode has a peripheral surface extending transverse to a longitudinal axis of the tip section, an inner surface facing the interior of the tip section, and an outer surface facing laterally away from the tip section;

wherein the distal insert includes at least one insulating element electrically insulating the mapping electrodes from the fluid path, wherein each insulating element cover the peripheral surface and the inner surface of its corresponding mapping electrode, wherein the at least one insulating element includes at least on insulated channel configured to electrically insulate wires extending from the plurality of mapping electrodes from the fluid path.

17. The system of claim 16, further comprising a distal insert positioned within the tip section separating the open interior region into a distal fluid reservoir and a proximal fluid reservoir, wherein the distal insert has a peripheral surface with openings therein sized to receive the at least one insulating element.

18. The system of claim 16, wherein the insulating elements extend outward from the exterior wall past an outside surface of the mapping electrodes.

19. An open-irrigated catheter system for performing mapping and ablation functions, comprising:

a tip section having an exterior wall that defines an open interior region within the tip section, wherein the exterior wall includes at least three mapping electrode openings and at least one irrigation port in fluid communication with the open interior region, wherein the exterior wall is conductive for delivering radio frequency (RF) energy for an RF ablation procedure;

a distal insert positioned within the tip section and separating the open interior region into a distal fluid reservoir and a proximal fluid reservoir, the distal insert defining a fluid conduit extending from the distal fluid reservoir to the proximal fluid reservoir, the distal insert having a peripheral surface with openings therein sized to receive the insulating elements, wherein the insulating elements electrically insulate the mapping electrodes from the distal insert, wherein at least one of the irrigation ports is in fluid communication with the distal fluid reservoir;

at least three mapping electrodes seated in the distal insert and aligned with the at least three mapping electrode openings;

at least three insulating elements surrounding the at least three mapping electrodes;

at least one insulated channel configured to electrically insulated wires extending from the at least three mapping electrodes from fluid within the open interior region.

20. The system of claim 19, wherein at least one of the irrigation ports is in fluid communication with the proximal fluid reservoir.