# US 11,439,457 B2 · Electrical energy ablation systems, devices and methods for the treatment of tissue

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- Number: US 11,439,457 B2
- Document ID: US11439457B2
- Status: Granted
- Kind: B2
- Application number: 16/711,236
- Filed: 2019-12-11
- Published: 2020-08-20
- Granted: 2022-09-13
- Earliest claimed: 2012-07-30
- Assignees: Fractyl Health, Inc.
- Applicants: Fractyl Health, Inc.
- Inventors: Jay Caplan; Harith Rajagopalan; J. Christopher Flaherty
- Web page: https://patentgrep.com/patent/US11439457B2

## CPC

- A61B 18/14: Probes or electrodes therefor
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 17/22012: {in direct contact with, or very close to, the obstruction or concrement (for removing obstructions in blood vessels by laser A61B18/245)}
- A61B 18/042: {using additional gas becoming plasma}
- A61B 18/1815: {using microwaves}
- A61B 18/20: using laser
- A61B 90/37: {Surgical systems with images on a monitor during operation}
- A61B 2018/00011: {with fluids}
- A61B 2018/0016: {Energy applicators arranged in a two- or three dimensional array}
- A61B 2018/00214: {Expandable means emitting energy, e.g. by elements carried thereon}
- A61B 2018/0022: {Balloons}
- A61B 2018/00267: {having a basket shaped structure}
- A61B 2018/00285: {Balloons}
- A61B 2018/00494: {Stomach, intestines or bowel}
- A61B 2018/00577: {Ablation}
- A61B 2018/00815: {measured by a thermistor}
- A61B 2018/00821: {measured by a thermocouple}
- A61B 2018/00875: {Resistance or impedance}
- A61B 2018/00982: {combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes}
- A61B 2018/1807: {using light other than laser radiation}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61B 2090/065: {for measuring contact or contact pressure}
- A61M 13/003: {Blowing gases other than for carrying powders, e.g. for inflating, dilating or rinsing}
- A61M 2202/0225: Carbon oxides, e.g. Carbon dioxide
- 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

A device for ablating target tissue of a patient with electrical energy is provided. An elongate shaft includes a proximal portion and a distal portion, and a radially expandable element is attached to the distal portion. An ablation element for delivering electrical energy to target tissue is mounted to the radially expandable element. The device can be constructed and arranged to ablate the duodenal mucosa of a patient while avoiding damage to the duodenal adventitial tissue. Systems and methods of treating target tissue are also provided.

## Claims

### Claim 1

A system for ablating tissue with electrical energy comprising:
an ablation device comprising:
an elongate shaft with a proximal portion and a distal portion; a radially expandable element attached to the elongate shaft distal portion; and
an ablation element mounted to the radially expandable element, the ablation element comprising a circumferential array of conductors, wherein the ablation element is constructed and arranged to deliver electrical energy to target tissue; and
an energy delivery unit constructed and arranged to deliver electrical energy to the ablation element of the ablation device, wherein the target tissue comprises duodenal mucosal tissue; and
wherein the energy delivery unit is configured to deliver the electrical energy to the ablation element to cause the target tissue to increase in temperature to a setpoint temperature between 60° C. and 90° C., wherein the system is configured to maintain the set point temperature for at least 5 seconds and to deliver energy to the ablation element with an average power density that is less than 20 watts per cm2; and
wherein the system is configured to deliver the electrical energy to cause non-desiccating ablation of the target tissue by avoiding creation of steam.

### Claim 2 (depends on 1)

The system according to claim 1, wherein the setpoint temperature comprises a temperature between 65° C. and 90° C.

### Claim 3 (depends on 1)

The system according to claim 1, wherein the setpoint temperature comprises a temperature between 75° C. and 85° C.

### Claim 4 (depends on 1)

The system according to claim 1, wherein the ablation device further comprises a fluid delivery element configured to deliver material into submucosal tissue to expand the submucosal tissue circumferentially.

### Claim 5 (depends on 4)

The system according to claim 4, wherein the fluid delivery element comprises multiple fluid delivery elements.

### Claim 6 (depends on 5)

The system according to claim 5, wherein the ablation device further comprises one or more vacuum ports positioned proximate the multiple fluid delivery elements, wherein the one or more vacuum ports are configured to apply a force to the submucosal tissue receiving the material.

### Claim 7 (depends on 1)

The system according to claim 1, wherein at least one conductor of the circumferential array of conductors has a width less than or equal to 1.0 mm.

### Claim 8 (depends on 7)

The system according to claim 7, wherein the at least one conductor comprises a width between 400 microns and 700 microns.

### Claim 9 (depends on 1)

The system according to claim 1, wherein a first conductor and a second conductor of the circumferential array of conductors are positioned with an edge-to-edge spacing between 200 microns and 2 mm.

### Claim 10 (depends on 1)

The system according to claim 1, wherein the ablation device further comprises at least one sensor configured to provide a signal.

### Claim 11 (depends on 10)

The system according to claim 10, wherein the radially expandable element comprises a balloon, and wherein the signal provided by the at least one sensor is configured to assess apposition of the balloon against a gastrointestinal wall.

### Claim 12 (depends on 1)

The system according to claim 1, wherein the system is constructed and arranged to maintain the target tissue at the set point temperature for at least 10 seconds.

### Claim 13 (depends on 12)

The system according to claim 12, wherein the system is constructed and arranged to maintain the target tissue at the set point temperature for 15 seconds to 25 seconds.

### Claim 14 (depends on 1)

The system according to claim 1, wherein the system is constructed and arranged to deliver energy in at least two-second energy delivery durations.

### Claim 15 (depends on 14)

The system according to claim 14, wherein the two-second energy delivery durations comprise non-continuous delivery of energy for two seconds.

### Claim 16 (depends on 1)

The system according to claim 1, wherein the system is configured to limit force applied to a duodenal wall to a level at or below 2.5 psi.

### Claim 17 (depends on 16)

The system according to claim 16, wherein the system is configured to limit force applied to the duodenal wall to a level at or below 1 psi.

### Claim 18 (depends on 1)

The system according to claim 1, wherein the system is configured to cause the radially expandable element to apply a force of at least 0.2 psi to a duodenal wall during the delivery of electrical energy to the target tissue.

### Claim 19 (depends on 18)

The system according to claim 18, wherein the system is configured to cause the radially expandable element to apply a force of at least 0.5 psi to the duodenal wall during the delivery of electrical energy to the target tissue.

### Claim 20 (depends on 1)

The system according to claim 1, wherein the system is constructed and arranged to treat a first length of duodenum in a first delivery of electrical energy and to treat a second length of duodenum in a second delivery of electrical energy.

### Claim 21 (depends on 20)

The system according to claim 20, wherein the system is constructed and arranged to treat at least a third length of duodenum with at least a third delivery of electrical energy.

### Claim 22 (depends on 1)

The system according to claim 1, wherein the temperature at the interface of the ablation element and the target tissue does not exceed 100° C.

### Claim 23 (depends on 1)

The system according to claim 1, wherein the system is configured to cause non-desiccating ablation by avoiding deleterious desiccation of tissue.

### Claim 24 (depends on 1)

The system according to claim 1, wherein the system is constructed and arranged to avoid detachment of tissue particles of the target tissue.

### Claim 25 (depends on 1)

The system according to claim 1, wherein the ablation element is configured to minimize electrical current driven temperature increase in at least an outermost 50% of the mucosal tissue layer.

### Claim 26 (depends on 25)

The system according to claim 25, wherein the at least outermost 50% of the mucosal tissue layer is ablated due to thermal conduction from at least an innermost 50%.

### Claim 27 (depends on 25)

The system according to claim 25, wherein the ablation element is further configured to maximize a flow of current through at least an innermost 50% of the mucosal tissue layer.

### Claim 28 (depends on 1)

The system according to claim 1, wherein the ablation element is configured to minimize electrical current driven temperature increase in at least an outermost 80% of the mucosal tissue layer.

### Claim 29 (depends on 28)

The system according to claim 28, wherein the at least outermost 80% of the mucosal tissue layer is ablated due to thermal conduction from at least an innermost 20% of the mucosal tissue layer.

### Claim 30 (depends on 28)

The system according to claim 28, wherein the ablation element is further configured to maximize a flow of current through at least an innermost 20% of the mucosal tissue layer.