# US 12,178,499 B2 · Catheter

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 12,178,499 B2
- Document ID: US12178499B2
- Status: Granted
- Kind: B2
- Application number: 16/154,651
- Filed: 2018-10-08
- Published: 2019-03-14
- Granted: 2024-12-31
- Earliest claimed: 2016-05-02
- Assignees: Affera, Inc.
- Applicants: Affera, Inc.
- Inventors: Doron Harlev; Ian Matthew Collier; Andrew Miles Wallace; Jonathan Matthew Bond
- Web page: https://patentgrep.com/patent/US12178499B2

## CPC

- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 1/00087: {Tools (A61B17/00234 takes precedence)}
- A61B 5/6843: {Monitoring or controlling sensor contact pressure}
- A61B 5/6852: {Catheters}
- A61B 18/1206: {Generators therefor}
- A61B 18/1233: {with circuits for assuring patient safety}
- A61B 18/14: Probes or electrodes therefor
- A61B 18/148: {having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy}
- A61B 18/1482: {having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy}
- A61M 3/0295: {with inflatable balloon}
- A61M 25/001: {Forming the tip of a catheter, e.g. bevelling process, join or taper}
- A61M 25/007: {Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked}
- A61M 25/0071: {Multiple separate lumens (multiple separate lumens throughout the catheter A61M25/0026)}
- A61M 25/0082: {Catheter tip comprising a tool}
- A61B 2017/00039: {Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect}
- A61B 2017/00053: {Mapping}
- A61B 2017/00154: {pulsed}
- A61B 2017/00477: {Coupling (A61B2017/0046 takes precedence)}
- A61B 2017/00526: {Methods of manufacturing}
- A61B 2017/00867: {shape memory effect}
- A61B 2018/00011: {with fluids}
- A61B 2018/00029: {open}
- A61B 2018/00065: {porous}
- A61B 2018/00077: {high, i.e. electrically conducting}
- A61B 2018/00083: {low, i.e. electrically insulating}
- A61B 2018/00089: {Thermal conductivity}
- A61B 2018/00101: {low, i.e. thermally insulating}
- A61B 2018/0016: {Energy applicators arranged in a two- or three dimensional array}
- A61B 2018/00166: {Multiple lumina}
- A61B 2018/00214: {Expandable means emitting energy, e.g. by elements carried thereon}
- A61B 2018/00238: {porous}
- A61B 2018/00267: {having a basket shaped structure}
- A61B 2018/00351: {Heart}
- A61B 2018/00357: {Endocardium}
- A61B 2018/00577: {Ablation}
- A61B 2018/00642: {with feedback, i.e. closed loop control}
- A61B 2018/00714: {Temperature}
- A61B 2018/00726: {Duty cycle}
- A61B 2018/00744: {Fluid flow}
- A61B 2018/00767: {Voltage}
- A61B 2018/00791: {Temperature}
- A61B 2018/00797: {measured by multiple temperature sensors}
- A61B 2018/00815: {measured by a thermistor}
- A61B 2018/00821: {measured by a thermocouple}
- A61B 2018/00839: {Bioelectrical parameters, e.g. ECG, EEG}
- A61B 2018/00875: {Resistance or impedance}
- A61B 2018/00904: {Automatic detection of target tissue}
- A61B 2018/0091: {Handpieces of the surgical instrument or device}
- A61B 2018/00982: {combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes}
- A61B 2018/00988: {Means for storing information, e.g. calibration constants, or for preventing excessive use, e.g. usage, service life counter}
- A61B 2018/1417: {Ball}
- A61B 2018/1465: {Deformable electrodes}
- A61B 2018/1467: {using more than two electrodes on a single probe}
- A61B 2090/061: {for measuring dimensions, e.g. length}
- A61B 2090/065: {for measuring contact or contact pressure}
- A61B 2090/376: {using X-rays, e.g. fluoroscopy}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61B 2217/007: with irrigation system
- A61B 2218/002: Irrigation
- A61B 2218/003: using a spray or a foam
- A61M 2205/0266: Shape memory materials
- A61M 2207/00: Methods of manufacture, assembly or production
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

Ablation systems of the present disclosure facilitate the safe formation of wide and deep lesions. For example, ablation systems of the present disclosure can allow for the flow of irrigation fluid and blood through an expandable ablation electrode, resulting in efficient and effective cooling of the ablation electrode as the ablation electrode delivers energy at a treatment site of the patient. Additionally, or alternatively, ablation systems of the present disclosure can include a deformable ablation electrode and a plurality of sensors that, in cooperation, sense the deformation of the ablation electrode, to provide a robust indication of the extent and direction of contact between the ablation electrode and tissue at a treatment site.

## Claims

### Claim 1

A catheter, comprising: an elongated shaft having a proximal end region and a distal end region; and a self-expanding, electrical energy delivery electrode at the distal end region of the elongated shaft, the electrical energy delivery electrode having a distalmost portion that defines a leading surface of the catheter that is resiliently deformable inward toward a proximal end portion of the electrical energy delivery electrode in response to application of an external force against the leading surface toward the proximal end portion and generally along a center axis defined by the elongated shaft, wherein—the electrical energy delivery electrode comprises multiple struts that define a plurality of bounded cells, the struts are configured to conduct and deliver electrical energy along a majority of their lengths, the struts are movable relative to one another, each strut comprises a first end portion, a second end portion, and a body portion disposed between the first and second end portions, wherein the first end portion, the second end portion, and the body portion define an edge of a respective cell of the plurality of bounded cells, in which the body portion of each of the respective struts of the respective cell has a different cross-sectional shape than the first and second end portions thereof, and wherein multiple cells of the plurality of bounded cells are located successively between the distalmost portion and the proximal end portion, and at least a portion of the struts are in electrical communication with one another to form a single electrical conductor.

### Claim 2 (depends on 1)

The catheter of claim 1 wherein the electrical energy delivery electrode comprises a braid.

### Claim 3 (depends on 1)

The catheter of claim 1 wherein the electrical energy delivery electrode comprises a mesh.

### Claim 4 (depends on 1)

The catheter of claim 1 wherein the struts are coupled to one another at joints.

### Claim 5 (depends on 1)

The catheter of claim 1 wherein the struts are moveable relative to one another such that a radial dimension of the electrical energy delivery electrode increases as the struts move relative to one another to transition the electrical energy delivery electrode from a compressed state, in the presence of a respective external force, to an uncompressed state, in the absence of the respective external force.

### Claim 6 (depends on 5)

The catheter of claim 5 wherein at least some of the cells of the plurality of cells have a larger area in the uncompressed state of the electrical energy delivery electrode than in the compressed state of the electrical energy delivery electrode.

### Claim 7 (depends on 5)

The catheter of claim 5 wherein, in the uncompressed state, at least some of the plurality of cells are substantially diamond-shaped.

### Claim 8 (depends on 5)

The catheter of claim 5 wherein, in the uncompressed state, at least some of the struts extend circumferentially with respect to the center axis defined by the proximal end region and the distal end region of the elongated shaft.

### Claim 9 (depends on 1)

The catheter of claim 1 wherein at least some of the struts collectively form a conductive surface through which the electrical energy is deliverable to target tissue.

### Claim 10 (depends on 9)

The catheter of claim 9 wherein the conductive surface spans a circumference of the respective cell of the plurality of cells.

### Claim 11 (depends on 9)

The catheter of claim 9 wherein the conductive surface spans an axial dimension and/or a radial dimension of the electrical energy delivery electrode.

### Claim 12 (depends on 1)

The catheter of claim 1 wherein the struts are composed of nitinol.

### Claim 13 (depends on 1)

The catheter of claim 1 wherein the electrical energy delivery electrode includes an inner portion and an outer portion opposite the inner portion, and wherein the inner portion is in fluid communication with the outer portion through the plurality of cells.

### Claim 14 (depends on 1)

The catheter of claim 1 wherein the elongated shaft defines the center axis extending from the proximal end region to the distal end region, and wherein at least some of the cells have a respective symmetry plane passing therethrough and containing the center axis of the elongated shaft.

### Claim 15 (depends on 1)

The catheter of claim 1 wherein the elongated shaft defines the center axis extending from the proximal end region to the distal end region, and wherein at least some of the cells have a respective symmetry plane passing through a distal end of the respective cell, a proximal end of the respective cell, and the center axis.

### Claim 16 (depends on 1)

The catheter of claim 1 wherein a combined area of the plurality of cells along an outer surface of the electrical energy delivery electrode is greater than a combined surface area of the struts along the outer surface of the electrical energy delivery electrode.

### Claim 17 (depends on 1)

The catheter of claim 1 wherein the respective cell of the plurality of cells is bounded by at least four of the struts.

### Claim 18 (depends on 1)

The catheter of claim 1, further comprising a fastener coupling the struts to one another to define a closed shape, wherein: a portion of the struts define eyelets through which the fastener extends to couple the portions of the struts to one another; the eyelets are aligned with one another; and the fastener extends through the eyelets at the distalmost portion of the electrical energy delivery electrode.

### Claim 19 (depends on 1)

The catheter of claim 1 wherein the electrical energy delivery electrode is configured to self-expand to a substantially spherical shape.

### Claim 20 (depends on 1)

The catheter of claim 1 wherein the electrical energy delivery electrode is configured to deliver electrical energy to tissue via the distalmost portion of the electrical energy delivery electrode.

### Claim 21

A catheter, comprising: an elongated shaft; and a self-expanding, ablation electrode at a distal end of the elongated shaft, the ablation electrode having a distalmost region that defines a leading surface of the catheter that is resiliently flexible inward in response to application of a threshold amount of an external force applied against the leading surface toward a proximal end region of the ablation electrode and generally along a longitudinal axis of the elongated shaft, wherein—the ablation electrode comprises struts that define a plurality of bounded cells, the struts are configured to conduct and deliver ablative energy along a majority of their lengths, each strut comprises a first end portion, a second end portion, and a body portion disposed between the first and second end portions, wherein the first end portion, the second end portion, and the body portion define an edge of a respective cell of the plurality of bounded cells, in which the body portion of at least some of the respective struts of the respective cell has a different cross-sectional shape than the first and second end portions thereof, and wherein multiple cells of the plurality of bounded cells are located successively between the distalmost region and the proximal end region, and two or more of the struts collectively form a conductive surface through which the ablative energy is deliverable to target tissue.

### Claim 22 (depends on 21)

The catheter of claim 21 wherein the ablation electrode is a unitary structure.

### Claim 23 (depends on 21)

The catheter of claim 21 wherein the two or more of the struts are mechanically connected to one another via welds or fasteners.

### Claim 24 (depends on 21)

The catheter of claim 21 wherein the ablation electrode is configured to deliver electrical energy to tissue via the distalmost region of the ablation electrode.

### Claim 25

A cardiac therapy catheter, comprising: an elongated shaft having a distal end region; and a self-expanding electrode at the distal end region of the elongated shaft, wherein—the self-expanding electrode includes a distalmost portion that defines a leading surface of the catheter that is resiliently flexible inward in response to application of an external force against the leading surface in a direction toward a proximal end region of the self-expanding electrode and generally parallel to a longitudinal axis of the elongated shaft, the self-expanding electrode comprises struts that define a plurality of bounded cells, the struts are configured to conduct and deliver electrical energy along a majority of their length, the struts are movable relative to one another, each strut comprises a first end portion, a second end portion, and a body portion disposed between the first and second end portions, wherein the first end portion, the second end portion, and the body portion define an edge of a respective cell of the plurality of bounded cells, in which the body portion of at least some of the respective struts of the respective cell is wider than the first and second end portions thereof, and wherein multiple cells of the plurality of bounded cells are located successively between the distalmost portion and the proximal end region, and at least a portion of the struts are in electrical communication with one another to form a single electrical conductor.