# US 10,869,719 B2 · Pulsed radiofrequency ablation

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- Number: US 10,869,719 B2
- Document ID: US10869719B2
- Status: Granted
- Kind: B2
- Application number: 15/584,533
- Filed: 2017-05-02
- Published: 2017-11-02
- Granted: 2020-12-22
- Earliest claimed: 2016-02-05
- Assignees: Affera, Inc.
- Applicants: Affera, Inc.
- Inventors: Doron Harlev; Andrew Miles Wallace; Luke Tsai
- Web page: https://patentgrep.com/patent/US10869719B2

## 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 and methods of the present disclosure are directed toward delivering pulsed radiofrequency (RF) energy to target tissue. The pulsations of the RF energy, combined with cooling at a surface of the target tissue, can advantageously promote local heat transfer in the target tissue to form lesions having dimensions larger than those that can be safely formed in tissue using non-pulsed RF energy under similar conditions.

## Claims

### Claim 1

A method comprising:
placing an expandable ablation electrode at an interface between tissue and blood in an anatomic structure of a patient, wherein the expandable ablation electrode is at a distal end portion of a catheter shaft and surrounds an irrigation port configured to direct irrigation fluid toward the interface, and wherein the irrigation port is coupled to the distal end portion of the catheter shaft at only a proximal end portion of the irrigation port;
delivering electrical energy to the ablation electrode at the interface during a period of lesion formation;
receiving, from a temperature sensor disposed at the interface, a signal indicative of temperature of the interface; and
delivering the irrigation fluid to the interface via the irrigation port during at least a portion of the period of lesion formation,
wherein—
the electrical energy delivered to the ablation electrode at the interface is changed between a first energy phase and a second energy phase during the period of lesion formation,
the electrical energy delivered in the first energy phase is greater than the electrical energy delivered in the second energy phase,
a combination of irrigation fluid and blood moves through the ablation electrode to cool the temperature of the interface during the period of lesion formation.

### Claim 2 (depends on 1)

The method of claim 1, wherein a rate of cooling of the interface by the combination of blood and irrigation fluid moving through the ablation electrode at the interface is greater than a rate of heating of the interface by the electrical energy during the second energy phase.

### Claim 3 (depends on 1)

The method of claim 1, wherein, during the period of lesion formation, the electrical energy is changed at least twice from the first energy phase to the second energy phase.

### Claim 4 (depends on 3)

The method of claim 3, wherein each of the second energy phases has a duration greater than 0 seconds and less than about 6 seconds.

### Claim 5 (depends on 3)

The method of claim 3, wherein each of the second energy phases has a predetermined duration.

### Claim 6 (depends on 3)

The method of claim 3, wherein each of the first energy phases has a predetermined duration.

### Claim 7 (depends on 1)

The method of claim 1, wherein a duration of one or more of the first energy phase and the second energy phase is based on the signal indicative of temperature of the interface.

### Claim 8 (depends on 1)

The method of claim 1, further comprising detecting a change in an electrical signal associated with the electrical energy delivered to the ablation electrode at the interface, wherein a duration of one or more of the first energy phase and the second energy phase is based on the detected change in the electrical signal.

### Claim 9 (depends on 1)

The method of claim 1, wherein a volumetric flow rate of the irrigation fluid is changed between a first volumetric flow rate and a second volumetric flow rate less than the first volumetric flow rate.

### Claim 10 (depends on 1)

The method of claim 1, wherein delivering the irrigation fluid to the interface includes mixing the irrigation fluid with blood moving through the ablation electrode at the interface.

### Claim 11

A method comprising:
positioning an expandable ablation electrode at an interface between tissue and blood in an anatomic structure of a patient, wherein the expandable ablation electrode is carried b a catheter shaft and surrounds an irrigation port configured to direct irrigation fluid toward the interface, and wherein the irrigation port is coupled to a distal end region of the catheter shaft at only a proximal end region of the irrigation port;
delivering electrical energy to the ablation electrode at the interface;
receiving, from a temperature sensor disposed at the interface, a signal indicative of temperature of the interface; and
delivering the irrigation fluid to the interface via the irrigation port during at least a portion of the period of lesion formation,
wherein—
the electrical energy delivered to the ablation electrode at the interface is changed between a first energy phase and a second energy phase during the period of lesion formation,
the electrical energy in the first energy phase is greater than the electrical energy delivered in the second energy phase,
a combination of irrigation fluid and blood moves across the interface to cool the temperature of the interface during the period of lesion formation.

### Claim 12 (depends on 11)

The method of claim 11, wherein a rate of cooling of the interface by the combination of blood and irrigation fluid moving through the ablation electrode at the interface is greater than a rate of heating of the interface by the electrical energy during the second energy phase.

### Claim 13 (depends on 11)

The method of claim 11, wherein, during the period of lesion formation, the electrical energy is changed at least twice from the first energy phase to the second energy phase.

### Claim 14 (depends on 13)

The method of claim 13, wherein each of the second energy phases has a duration greater than 0 seconds and less than about 6 seconds.

### Claim 15 (depends on 13)

The method of claim 13, wherein each of the first energy phases and/or each of the second energy phases has a predetermined duration.

### Claim 16 (depends on 11)

The method of claim 11, wherein a duration of one or more of the first energy phase and the second energy phase is based on the signal indicative of temperature of the interface.

### Claim 17 (depends on 11)

The method of claim 11, further comprising detecting a change in an electrical signal associated with the electrical energy delivered to the ablation electrode at the interface, wherein a duration of one or more of the first energy phase and the second energy phase is based on the detected change in the electrical signal.

### Claim 18 (depends on 11)

The method of claim 11, wherein a volumetric flow rate of the irrigation fluid is changed between a first volumetric flow rate and a second volumetric flow rate less than the first volumetric flow rate.

### Claim 19

A method comprising:
placing an expandable ablation electrode at an interface between tissue and blood in an anatomic structure of a patient, wherein the expandable ablation electrode is at a distal portion of a catheter shaft and surrounds an irrigation port configured to direct irrigation fluid toward the interface, and further wherein the irrigation port is connected to the distal portion of the catheter shaft at only a proximal end portion of the irritation port;
delivering electrical energy to the ablation electrode at the interface during a period of lesion formation;
receiving, from a temperature sensor disposed at the interface, a signal indicative of temperature of the interface; and
delivering the irrigation fluid to the interface via the irrigation port during at least a portion of the period of lesion formation,
wherein—
the electrical energy delivered to the ablation electrode at the interface is changed between a first energy phase and a second energy phase during the period of lesion formation,
the electrical energy delivered in the first energy phase is greater than the electrical energy delivered in the second energy phase,
a duration of the first energy phase is less than a duration of the second energy phase, and
a combination of irrigation fluid and blood moves through the ablation electrode to cool the temperature of the interface during the period of lesion formation.
