Embedded thermocouple in denervation flex circuit

• US 10,271,898 B2
• Filed: 10/22/2014
• Issued: 04/30/2019
• Est. Priority Date: 10/25/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Cao, Hong, Larson, Kenneth R.
• Primary Examiner(s): Kim, Eun Hwa
• Application Number:
  US14/520,937
• Publication Number:
  US 20150119882A1
• Time in Patent Office: 1,651 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 18/16 Indifferent or passive electrodes for grounding
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00797 measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2018/1465 Deformable electrodes
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 2018/162 located on the probe body
• CPC Class Codes: A61B 2018/165 Multiple indifferent electrodes
• CPC Class Codes: A61B 2562/0271 Thermal or temperature sensors
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20

Abstract

A medical device for sympathetic nerve ablation may include a catheter shaft, an expandable member disposed on or coupled to the catheter shaft, and a plurality of elongate electrode assemblies each constructed as a flexible circuit having a plurality of layers. The expandable member may be configured to shift between an unexpanded configuration and an expanded configuration. The plurality of electrode assemblies may be disposed on an outer surface of the expandable member. Each of the plurality of electrode assemblies may include a temperature sensor within the plurality of layers.

Claims

1. A medical device for sympathetic nerve ablation, comprising:

a catheter shaft;

an expandable balloon disposed on the catheter shaft, the expandable balloon being capable of shifting between an unexpanded configuration and an expanded configuration; and

a plurality of elongate electrode assemblies each constructed as a flexible circuit having a plurality of layers comprising a base layer facing the expandable balloon and an insulating layer, the plurality of elongate electrode assemblies attached to an outer surface of the expandable balloon;

wherein each of the plurality of elongate electrode assemblies includes a temperature sensor and a sensor ground pad, wherein the temperature sensor and the sensor ground pad are embedded within the plurality of layers, between the base layer and the insulating layer and wherein the sensor ground pad is between the temperature sensor and the insulating layer.

2. The medical device of claim 1, wherein the plurality of elongate electrode assemblies each include a plurality of electrodes.

3. The medical device of claim 2, wherein the plurality of elongate electrode assemblies each include a plurality of active electrodes and a plurality of ground electrodes.

4. The medical device of claim 3, wherein the temperature sensor is positioned between the plurality of active electrodes and the plurality of ground electrodes.

5. The medical device of claim 1, wherein the expandable balloon is a non-compliant balloon and the plurality of elongate electrode assemblies unfold and fold with the expandable balloon.

6. The medical device of claim 1, wherein the plurality of layers and the temperature sensor combine to define an overall thickness of each of the plurality of elongate electrode assemblies at the temperature sensor.

7. The medical device of claim 6, wherein the temperature sensor is a sputtered thermocouple.

8. The medical device of claim 6, wherein the temperature sensor comprises less than 5 percent of the overall thickness.

9. The medical device of claim 6, wherein the temperature sensor comprises less than 1 percent of the overall thickness.

10. A medical device for sympathetic nerve ablation, comprising:

a catheter shaft;

an expandable member coupled to the catheter shaft, the expandable member being capable of shifting between an unexpanded configuration and an expanded configuration; and

a plurality of elongate electrode assemblies each constructed as a flexible circuit having a length and a plurality of layers comprising a base layer facing the expandable member and an insulating layer, the plurality of elongate electrode assemblies attached to an outer surface of the expandable member;

wherein each of the plurality of elongate electrode assemblies includes a sputtered thermocouple and a sensor ground pad, wherein the sputtered thermocouple and the sensor ground pad are embedded within the plurality of layers between the base layer and the insulating layer, wherein the sensor ground pad is between the sputtered thermocouple and the insulating layer, and wherein the sputtered thermocouple is positioned between at least one active electrode and at least one ground electrode.

11. The medical device of claim 10, wherein a side of the plurality of elongate electrode assemblies that faces the expandable member forms an uninterrupted surface.

12. The medical device of claim 11, when the plurality of elongate electrode assemblies is disposed in a flattened configuration, the uninterrupted surface is substantially planar.

13. The medical device of claim 10, wherein the plurality of layers forms a substantially constant thickness over the length of each of the plurality of elongate electrode assemblies.

14. The medical device of claim 10, wherein the at least one active electrode and the at least one ground electrode protrude outwardly from the plurality of layers on a side opposite the outer surface of the expandable member.

15. A medical device for sympathetic nerve ablation within a body passageway, comprising:

a catheter shaft;

an elongate balloon coupled to the catheter shaft, the elongate balloon being capable of shifting between an unexpanded configuration and an expanded configuration; and

a plurality of elongate electrode assemblies each constructed as a flexible circuit having a plurality of layers comprising a base layer facing the elongate balloon and an insulating layer, the plurality of elongate electrode assemblies being bonded to an outer surface of the elongate balloon;

wherein each of the plurality of elongate electrode assemblies includes a temperature sensor and a sensor ground pad, wherein the temperature sensor and the sensor ground pad are embedded within the plurality of layers between the base layer and the insulating layer, wherein the sensor ground pad is between the temperature sensor and the insulating layer, and wherein the temperature sensor comprises less than five percent of a maximum thickness of each of the plurality of elongate electrode assemblies.

16. The medical device of claim 15, wherein the temperature sensor is a sputtered thermocouple.

17. The medical device of claim 15, wherein at least a region of the flexible circuit along the temperature sensor has a substantially constant thickness.

18. The medical device of claim 15, wherein the flexible circuit is free of a radial protrusion adjacent to the temperature sensor.

19. The medical device of claim 15, wherein the temperature sensor comprises less than 1 percent of the overall thickness.

20. The medical device of claim 16, wherein the temperature sensor comprises less than 1 percent of the overall thickness.