LOW PROFILE ELECTRODE ASSEMBLY

• US 20100204560A1
• Filed: 11/11/2009
• Published: 08/12/2010
• Est. Priority Date: 11/11/2008
• Status: Active Grant

• Current Assignee: Shifamed Holdings, LLC
• Original Assignee: Shifamed Holdings, LLC
• Inventors: Lepak, Jonah, Leung, Emma, Brand, Brian, Claude, John P., Salahieh, Amr
• Granted Patent: US 8,295,902 B2
• Time in Patent Office: Days
• US Class Current: 600/373
• CPC Class Codes: A61B 18/1206 Generators therefor
• 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 2017/003 Steerable
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• 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 2018/00232 having an irregular shape
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00357 Endocardium
• CPC Class Codes: A61B 2018/00375 Ostium, e.g. ostium of pulmonary vein or artery
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00702 : Power or energy
• CPC Class Codes: A61B 2018/00744 : Fluid flow
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00797 : measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00839 : Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/00898 : Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/124 : switching the output to different electrodes, e.g. sequentially
• CPC Class Codes: A61B 2018/1465 : Deformable electrodes
• CPC Class Codes: A61B 2090/3966 : Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 2562/125 : characterised by the manufacture of electrodes
• 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
• CPC Class Codes: A61B 5/287 : Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/6846 : specially adapted to be brought in contact with an internal body part, i.e. invasive
• CPC Class Codes: A61N 1/05 : for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: C08L 2201/12 : Shape memory

Abstract

A tissue electrode assembly includes a membrane configured to form an expandable, conformable body that is deployable in a patient. The assembly further includes a flexible circuit positioned on a surface of the membrane and comprising at least one base substrate layer, at least one insulating layer and at least one planar conducting layer. An electrically-conductive electrode covers at least a portion of the flexible circuit and a portion of the surface of the membrane not covered by the flexible circuit, wherein the electrically-conductive electrode is foldable upon itself with the membrane to a delivery conformation having a diameter suitable for minimally-invasive delivery of the assembly to the patient.

Claims

1. A tissue electrode assembly, comprising:

a membrane configured to form an expandable, conformable body that is deployable in a patient;

a flexible circuit positioned on a surface of the membrane and comprising at least one base substrate layer, at least one insulating layer and at least one planar conducting layer; and

an electrically-conductive electrode that covers at least a portion of the flexible circuit and a portion of the surface of the membrane not covered by the flexible circuit, wherein the electrically-conductive electrode is foldable upon itself with the membrane to a delivery conformation having a diameter suitable for minimally-invasive delivery of the assembly to the patient.

2. The assembly of claim 1, wherein the base or insulating layer comprises a substrate layer of insulating material and the planar conducting layer comprises a conducting material covering at least a portion of the substrate layer of insulating material.

3. The assembly of claim 2, wherein the insulating material is selected from the group comprising at least one of polyimide, polyester, polyethylene Terephthalate, polyaryletheretherketone, polytetrafluoroethylene, polyethylene naphthalate, liquid crystal polymer, photoimageable coverlay, thin epoxy glass, polyimide glass, and acrylic adhesive.

4. The assembly of claim 2, wherein the conducting material is selected from the group comprising at least one of copper, gold, silver, tin, nickel, steel, cupronickel, and nickel-cobalt ferrous alloy.

5. The assembly of claim 2, wherein the conducting layer is further covered at least in part by a dielectric layer of insulating material.

6. The assembly of claim 5, wherein the flexible circuit comprises a main lead that splits into at least two branches having one or more conductive traces.

7. The assembly of claim 6, wherein each conductive trace comprises a conductive pad comprising a region of exposed conductive layer not covered by the dielectric layer of insulating material.

8. The assembly of claim 7, wherein a region of the substrate layer of insulating material underlying the conductive pad has an enlarged width compared to a region of the substrate layer of insulating material underlying the conductive trace.

9. The assembly of claim 8, wherein the region of the substrate layer of insulating material underlying the conductive pad further comprises one or more holes to provide for better adhesion between the flexible circuit and the membrane.

10. The assembly of claim 6, wherein at least one conductive trace comprises at least two conductive pads.

11. The assembly of claim 1, wherein the portion of the flexible circuit covered by the electrically-conductive electrode comprises the conductive pad.

12. The assembly of claim 11, wherein the electrically-conductive electrode has a surface area that is larger than a surface area of the conductive pad.

13. The assembly of claim 1, wherein the electrically-conductive electrode directly contacts tissue to be energized.

14. The assembly of claim 1, wherein the electrically-conductive electrode comprises a material selected from the group comprising at least one of electro-conductive ink, optical ink, polymer-based ink, silver flake adhesive, gold and platinum.

15. The assembly of claim 1, wherein the electrically-conductive electrode is deposited by a technique selected from the group comprising at least one of printing, painting, spraying, soldering, bonding, vacuum deposition, and positive material deposition.

16. The assembly of claim 1, wherein the electrically-conductive electrode does not alter membrane conformability.

17. The assembly of claim 1, wherein the electrically-conductive electrode emits energy selected from the group comprising at least one of monopolar radiofrequency, bipolar radiofrequency, microwave, high voltage and electroporation.

18. The assembly of claim 1, further comprising more than one flexible circuit.

19. The assembly of claim 1, wherein the electrode assembly comprises at least five flexible circuits, each flexible circuit splitting into at least two branches having one or more conductive traces and each conductive trace powering at least one electrically-conductive electrodes.

20. The assembly of claim 19, wherein the electrically-conductive electrodes are individually controlled.

21. The assembly of claim 1, further comprising at least one temperature sensor mounted on the flexible circuit and positioned adjacent an electrically-conductive film electrode.

22. The assembly of claim 21, wherein the temperature sensor shares a conductive trace with the electrically-conductive electrode.

23. The assembly of claim 21, wherein the temperature sensor positioned adjacent an electrically-conductive electrode is less than about 1 mm away from the electrically-conductive electrode.

24. The assembly of claim 21, wherein the temperature sensor comprises a surface mount thermistor, a thermocouple, a platinum resistance thermometer or a resistance temperature detector.

25. The assembly of claim 1, wherein the expandable, conformable body is self-expanding.

26. The assembly of claim 1, wherein the expandable, conformable body of the membrane is fluid-tight.

27. The assembly of claim 1, wherein the expandable, conformable body of the membrane is woven.

28. The assembly of claim 1, wherein the expandable, conformable body has a shape that is selected from the group comprising tubular, spherical, toroid, conical, branched, pronged, tapered, and asymmetrical.

29. The assembly of claim 1, wherein the membrane comprises a material selected from the group comprising at least one of polyvinyl chloride, polyethylene, cross-linked polyethylene, polyolefins, polyolefin copolymer, polyethylene terephthalate, nylon, polymer blends, polyester, polyimide, polyamides, polyurethane, silicone, latex, mylar elastomer, and polydimethylsiloxane.

30. The assembly of claim 1, wherein the membrane is coupled to a distal end of a catheter configured for minimally-invasive delivery.

31. The assembly of claim 30, wherein the delivery conformation comprises the membrane folded distal to the distal end of the catheter and the electrically-conductive electrode folded upon itself.

32. The assembly of claim 30, wherein the flexible circuit comprises a main lead that splits into at least two branches having one or more conductive traces, wherein the main lead is routed through an inner diameter of the catheter and exits the catheter inner diameter at a proximal region of the membrane.

33. The assembly of claim 32, wherein the main lead of the flexible circuit is routed through an inner diameter of the membrane and exits the membrane inner diameter at a distal region of the membrane.