Low Profile Electrode Assembly

• US 20120071870A1
• Filed: 05/12/2011
• Published: 03/22/2012
• Est. Priority Date: 11/11/2008
• Status: Active Grant

• Current Assignee: Shifamed Holdings, LLC
• Original Assignee: Shifamed Holdings, LLC
• Inventors: SALAHIEH, Amr, LEPAK, Jonah, LEUNG, Emma, BRANDT, Brian D., CLAUDE, John P., SAUL, Tom
• Granted Patent: US 8,805,466 B2
• Time in Patent Office: Days
• US Class Current: 606/33
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/00165 with light-conductive means, e.g. fibre optics A61B1/07 takes precedence
• CPC Class Codes: A61B 1/00179 for off-axis viewing
• CPC Class Codes: A61B 1/00181 for multiple fixed viewing angles A61B1/00193 takes precedence
• CPC Class Codes: A61B 1/05 characterised by the image sensor, e.g. camera, being in the distal end portion
• CPC Class Codes: A61B 1/06 with illuminating arrangements
• CPC Class Codes: A61B 1/0676 at distal tip of an endoscope
• CPC Class Codes: A61B 1/0684 using light emitting diodes [LED]
• CPC Class Codes: A61B 1/07 using light-conductive means, e.g. optical fibres
• 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 18/1815 using microwaves
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• 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 2018/00238 : porous
• 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 reversible electroporation A61N1/327
• 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 2018/0212 : using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/0262 : using a circulating cryogenic fluid
• 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 2090/065 : for measuring contact or contact pressure
• CPC Class Codes: A61B 2090/3966 : Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 2217/007 : with irrigation system
• CPC Class Codes: A61B 2562/125 : characterised by the manufacture of electrodes
• 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
• CPC Class Codes: A61B 5/287 : Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/6853 : with a balloon
• CPC Class Codes: A61B 5/6855 : with a distal curved tip
• CPC Class Codes: A61B 5/6858 : with a distal basket, e.g. expandable basket
• CPC Class Codes: A61M 2025/0681 : Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0108 : using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0133 : Tip steering devices
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/04 : in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61N 1/05 : for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 5/02 : using microwaves
• 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 catheter and electrode assembly comprising:

an elongate catheter body comprising a distal portion;

an expandable electrode structure coupled to the distal portion,

wherein the expandable electrode structure comprises

an expandable membrane with an expanded configuration, and

a branched flexible circuit having a substrate layer and planar conducting layer electrically coupled to a plurality of radio frequency ablation electrodes and at least one sensing electrode,

wherein in the expanded configuration at least four of the electrodes are disposed in an array on a distal surface of the membrane.

2. The assembly of claim 1, wherein the at least four electrodes are adapted to be substantially coplanar with a distal tip of the catheter body when the membrane is in the expanded configuration.

3. The assembly of claim 1, wherein the at least four electrodes are distal to the distal tip of the catheter when the membrane is in the expanded configuration.

4. The assembly of claim 1, wherein a first membrane portion comprising at least 15% of the surface area of the membrane is distal to a distal tip of the catheter body, and wherein the at least four electrodes are disposed on the first membrane portion.

5. The assembly of claim 1, wherein at least 10% of the volume of the membrane is distal to a distal tip of the catheter when the membrane is in the expanded configuration.

6. The assembly of claim 1, wherein first and second opposite sides of a surface of the membrane are coupled to the catheter body.

7. The assembly of claim 1, wherein a plurality of perforation holes traverse the membrane.

8. The assembly of claim 1, further comprising an annular introducer wherein the introducer surrounds the expandable membrane and confines the diameter thereof to less than about 0.2 inches.

9. The assembly of claim 8, wherein the introducer is adapted to engage a collapsed exterior of the expandable membrane and confine a portion of the membrane substantially distal to the distal end of the catheter body.

10. The assembly of claim 1 wherein the expanded configuration is an inflated configuration.

11. A unitary flexible circuit comprising:

a proximal end, a distal end, and an intermediate portion, wherein

the proximal end is coupled to an electrical source,

the intermediate portion is comprised of a plurality of flexible branches separated from one another along their lengths, wherein at least one branch has an insulating layer along a portion thereof and at least one branch is electrically connected to an electrode adapted to deliver radio frequency energy, wherein the flexible branches conform to a portion of a medical device adapted to be minimally-invasively delivered to a location within a subject,

and wherein the plurality of branches are coupled to one another distal to the intermediate portion.

12. The unitary flexible circuit of claim 11, wherein the length of at least one branch in the intermediate portion is between about 1 cm and about 5 cm.

13. The flexible circuit of claim 11 wherein the flexible branches conform to a radially outer surface of the portion of the medical device.

14. The unitary flexible circuit of claim 11, wherein the branches of the intermediate portion conform to the portion of the medical device such that they are oriented in a configuration surrounding a longitudinal axis of the medical device.

15. The unitary flexible circuit of claim 14, wherein the branches extend substantially 360 degrees around the longitudinal axis and at least two of the plurality of branches are separated by more than 30 degrees from an adjacent branch.

16. The unitary flexible circuit of claim 11, wherein any two branches are separated by more than 10 degrees.

17. The unitary flexible circuit of claim 11, wherein any two branches are separated by more than 90 degrees.

18. The unitary flexible circuit of claim 11, wherein the plurality of branches of the intermediate portion are fixed on the medical device such that the medical device maintains the separation between the branches.

19. The unitary flexible circuit of claim 18, wherein the portion of the medical device is an expandable membrane.

20. The unitary flexible circuit of claim 19, wherein the orientation of the branches of the intermediate portion depends on the inflation of the expandable membrane.

21. The unitary flexible circuit of claim 20, wherein a portion of the expandable membrane and a portion of a plurality of the branches are located distally to the distal end when the expandable membrane is in an expanded configuration.

22. The unitary flexible circuit of claim 11, wherein at least two of the branches are comprised of a plurality of electrodes adapted to deliver radio frequency (RF) energy.

23. The unitary flexible circuit of claim 22, wherein the distal end is comprised of a sensing electrode spaced apart from the plurality of electrodes.

24. The unitary flexible circuit of claim 11, wherein the proximal end is coupled to a catheter.

25. The unitary flexible circuit of claim 24, wherein the catheter is sealed along a length thereof extending from the proximal end to the intermediate portion.

26. The unitary flexible circuit of claim 11, wherein at least three branches terminate in a connector at the proximal end.

27. The unitary flexible circuit of claim 11, wherein portions of the medical device are adapted to be folded by selective orientation of the plurality of branches.