Medical devices with a flexible electrode assembly coupled to an ablation tip

• US 10,603,105 B2
• Filed: 10/23/2015
• Issued: 03/31/2020
• Est. Priority Date: 10/24/2014
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Cheung, Desmond, Potosky, John C., Marecki, Andrew T., Kim, Isaac J., Mirigian, Mark D.
• Primary Examiner(s): Peffley, Michael F
• Assistant Examiner(s): Ouyang, Bo
• Application Number:
  US14/922,023
• Publication Number:
  US 20160113712A1
• Time in Patent Office: 1,621 Days
• 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 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/1405 Electrodes having a specific shape
• CPC Class Codes: A61B 2018/1465 Deformable electrodes
• CPC Class Codes: A61B 2018/1495 Electrodes being detachable from a support structure
• CPC Class Codes: A61B 2562/166 the sensor is mounted on a specially adapted printed circuit board
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/6859 with multiple distal splines

Abstract

Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a catheter for use in cardiac mapping and/or ablation. The catheter may include an elongate catheter shaft having a distal ablation electrode region capable of ablating tissue. An electrode assembly may be coupled to the distal ablation electrode region. The electrode assembly may include a flexible circuit having one or more electrodes disposed thereon.

Claims

1. A catheter for use in cardiac mapping and/or ablation, the catheter comprising:

an elongate catheter shaft having a distal ablation electrode configured to contact and provide ablation energy to tissue, wherein the distal ablation electrode comprises a plurality of openings extending through an exterior surface of the distal ablation tip;

an electrode assembly releasably coupled to the distal ablation electrode, wherein the electrode assembly comprises a plurality of members, wherein each member of the plurality of members passes through a respective opening of the plurality of openings to fix the electrode assembly relative to the distal ablation electrode when the electrode assembly is coupled to the distal ablation electrode; and

wherein the electrode assembly includes a flexible circuit having one or more electrodes disposed thereon.

2. The catheter of claim 1, wherein the electrode assembly includes a region that is disposed along a distal end of the distal ablation electrode.

3. The catheter of claim 1, wherein the plurality of members comprises wherein each member of the plurality of members includes at least one electrode.

4. The catheter of claim 3, wherein the electrode assembly includes three or more members.

5. The catheter of claim 3, wherein the electrode assembly includes four or more members.

6. The catheter of claim 1, wherein each member has an arrow shape.

7. The catheter of claim 1, wherein each member has relief cutouts.

8. The catheter of claim 1, wherein the catheter shaft includes an inner channel, wherein the distal ablation electrode region includes a first opening, and wherein the electrode assembly extends along the inner channel, through the first opening.

9. The catheter of claim 1, wherein the electrode assembly is adhesively bonded to the distal ablation electrode.

10. The catheter of claim 1, wherein the electrode assembly includes one or more electrode regions and one or more electrically insulated regions.

11. The catheter of claim 1, wherein the electrode assembly extends circumferentially around the distal ablation electrode.

12. The catheter of claim 1, wherein the electrode assembly is designed to bow radially outward from the distal ablation electrode.

13. The catheter of claim 1, wherein the distal ablation electrode includes a platinum ablation tip electrode.

14. The catheter of claim 1, wherein each member has a rounded shape.

15. A method for manufacturing a medical device, the method comprising:

inserting an electrode assembly into a channel formed within a distal ablation tip of a catheter, the distal ablation tip configured to contact and provide ablation energy to tissue;

wherein the electrode assembly includes a flexible circuit having one or more electrodes disposed thereon, wherein the electrode assembly comprises a plurality of members;

wherein the distal ablation tip includes a first opening and a second opening extending through an exterior surface of the distal ablation tip; and

extending electrode assembly through the first opening, along an outer surface of the distal ablation tip, and a member of the plurality of members through the second opening to couple and fix the electrode assembly relative to the distal ablation tip.

16. A catheter for use in cardiac mapping and/or ablation, the catheter comprising:

an elongate catheter shaft having an inner channel and a distal end region;

a distal ablation tip configured to ablate tissue disposed near the distal end region;

an electrode assembly releasably coupled to the distal ablation tip;

wherein the electrode assembly includes a flexible circuit having a plurality of arm regions, wherein each arm region includes one or more electrodes disposed thereon;

wherein the distal ablation electrode region includes a first opening and a second opening extending through an exterior surface of the distal ablation tip;

wherein the electrode assembly extends along the inner channel, through the first opening, and wherein an arm region of the plurality of arm regions extends along an outer surface of the distal ablation tip and through the second opening to mechanically secure the electrode assembly to the distal ablation tip.

17. The catheter of claim 16, wherein the electrode assembly includes a region that is disposed along a distal end of the distal ablation tip.

18. The catheter of claim 16, wherein each arm region has an arrow shape.

19. The catheter of claim 16, wherein each arm region has relief cutouts.

20. The catheter of claim 16, wherein each member has a rounded shape.