# US 12,005,159 B2 · Conformal, non-occluding sensor array for cardiac mapping and ablation

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- Number: US 12,005,159 B2
- Document ID: US12005159B2
- Status: Granted
- Kind: B2
- Application number: 17/774,440
- Filed: 2020-11-06
- Published: 2022-12-08
- Granted: 2024-06-11
- Earliest claimed: 2019-11-07
- Assignees: Cornell University
- Applicants: Cornell University
- Inventors: Nazanin Farokhnia; Alexandre Caprio; Varun Umesh Kashyap; Subhi Al' Aref; Bobak Mosadegh; James K. Min; Simon Dunham
- Web page: https://patentgrep.com/patent/US12005159B2

## CPC

- A61B 5/6858: {with a distal basket, e.g. expandable basket}
- A61L 29/16: Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)}
- A61B 5/287: Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61L 29/08: Materials for coatings
- A61B 2017/00022: {Sensing or detecting at the treatment site}
- A61B 2017/00035: {pH}
- A61B 2017/00053: {Mapping}
- A61B 2017/00084: {Temperature}
- A61B 2017/00106: {ultrasonic}
- A61B 2017/00526: {Methods of manufacturing}
- A61B 2017/00557: {inflatable (A61B2017/22051 takes precedence)}
- A61B 2018/00029: {open}
- A61B 2018/0016: {Energy applicators arranged in a two- or three dimensional array}
- A61B 2018/0022: {Balloons}
- A61B 2018/00267: {having a basket shaped structure}
- A61B 2018/00357: {Endocardium}
- A61B 2018/00577: {Ablation}
- A61B 2018/00797: {measured by multiple temperature sensors}
- A61B 2018/00839: {Bioelectrical parameters, e.g. ECG, EEG}
- A61B 2018/00863: {Fluid flow}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61B 2090/065: {for measuring contact or contact pressure}
- A61B 2218/002: Irrigation
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

Systems, methods, and devices having improved conformal properties for biomedical signal measurement are disclosed. A device can have a first polymer substrate coupled to a conductive layer forming a conductive trace electrically coupled to a conductive pad exposed via an opening. The device can have a second polymer substrate forming a first cavity between the first polymer substrate and the second polymer substrate. The device can have a first inlet portion that receives a fluid that expands the first cavity causing the device to conform to an anatomical structure. The structure can be an atrium, such as the left atrium, of the heart of a patient. The device can conform to the walls of the tissue structure, and the conductive pad exposed via the opening can detect a signal from the wall of the tissue structure. The signal can be provided to an external measurement device for processing.

## Claims

### Claim 1

A device with improved structural conformity, comprising:
a first polymer substrate having a first surface coupled to a conductive layer forming a conductive trace electrically coupled to a conductive pad exposed through a second surface of the first polymer substrate via an opening in the first polymer substrate;
a second polymer substrate forming a first cavity between the first polymer substrate and the second polymer substrate; and
a first inlet portion that receives a fluid that expands the first cavity causing the device to at least partially conform to an anatomical structure,
wherein the conductive pad detects a signal from the anatomical structure.

### Claim 2 (depends on 1)

The device of claim 1, wherein the first polymer substrate, the second polymer substrate, and the first inlet portion form a first soft-electronic beam of a plurality of soft-electronic beams, and wherein the plurality of soft-electronic beams form a three-dimensional structure that conforms to the anatomical structure responsive to receiving the fluid.

### Claim 3 (depends on 2)

The device of claim 2, wherein the three-dimensional structure formed by the plurality of soft-electronic beams is at least one of a star configuration, a sphere configuration, a linear configuration, a conical configuration, or a cylindrical configuration.

### Claim 4 (depends on 1)

The device of claim 1, wherein at least one of the first polymer or the second polymer comprise at least one of a urethane polymer, a polyurethane polymer, a copolymer, a silicone polymer, or an elastomer.

### Claim 5 (depends on 1)

The device of claim 1, wherein the conductive trace provides the signal detected by the conductive pad to a catheter that transmits the signal to an external measurement device.

### Claim 6 (depends on 1)

The device of claim 1, wherein the conductive trace is coupled to a portion of a flexible printed-circuit board substrate that is coupled to at least one of the first polymer substrate or the second polymer substrate.

### Claim 7 (depends on 1)

The device of claim 1, wherein one or more of the conductive pad or the conductive trace is electrically coupled to a sensor comprising at least one of a force sensor, a shear sensor, an ultrasound senor, a thermal sensor, a position sensor, an electrocardiogram sensor, or an electrochemical sensor.

### Claim 8 (depends on 7)

The device of claim 7, wherein the sensor is coupled to at least one of the first polymer substrate, the second polymer substrate, or a flexible printed-circuit board layer coupled to the conductive layer and to at least one of the first polymer substrate or the second polymer substrate.

### Claim 9 (depends on 7)

The device of claim 7, wherein the second polymer substrate is coupled to a second conductive trace electrically coupled to a second conductive pad; and wherein the second conductive pad is coupled to a second sensor comprising at least one of a force sensor, a shear sensor, an ultrasound senor, a thermal sensor, a position sensor, an electrocardiogram sensor, or an electrochemical sensor.

### Claim 10 (depends on 1)

The device of claim 1, wherein the conductive trace is patterned in at least one of a serpentine pattern, a linear pattern, a curved pattern, or a zig-zag pattern, wherein the conductive trace stretches in response to the first inlet portion receiving the fluid that expands the first cavity.

### Claim 11

A method of detecting signals using an expandable measurement device, comprising:
positioning a measurement device within an internal anatomical structure of a patient, the measurement device comprising:
a first polymer substrate having a first surface coupled to a conductive layer forming a conductive trace electrically coupled to a conductive pad exposed through a second surface of the first polymer substrate via an opening in the first polymer substrate;
a second polymer substrate secured to the first polymer substrate and forming a first cavity between the first polymer substrate and the second polymer substrate; and
a first inlet portion coupled to a lumen that receives a fluid that expands the first cavity;
providing, via the lumen, a first amount of the fluid that causes the measurement device to expand by a volume corresponding to the first amount of fluid, wherein the conductive pad detects a signal from the internal anatomical structure via the opening responsive to expanding the first cavity; and
monitoring, responsive to providing the first amount of the fluid via the lumen, using a measurement device, the signal detected by the conductive pad.

### Claim 12 (depends on 11)

The method of claim 11, further comprising:
determining that the signal from the internal anatomical structure is not detected by the conductive pad responsive providing the first amount of the fluid; and
providing, responsive to the determination that the signal is not detected, a second amount of the fluid that causes the cavity to a size larger than the size of the cavity after providing the first amount of the fluid.

### Claim 13 (depends on 11)

The method of claim 11, wherein monitoring the signal using the measurement device further comprises measuring at least one of a force value, a shear force value, an ultrasound value, a temperature value, a position value, an electrocardiogram value, or an electrochemical value.

### Claim 14 (depends on 11)

The method of claim 11, wherein providing the first amount of fluid comprises determining the first amount of the fluid based on at least one of a type of the internal anatomical structure, a volume of the measurement device, or information from an image of the internal anatomical structure.

### Claim 15 (depends on 11)

The method of claim 11, wherein the internal anatomical structure is an atrium of a heart of the patient, and wherein positioning the measurement device within the internal tissue structure is performed using at least a transseptal puncture.
