# US 10,869,718 B2 · Methods and systems for treating diabetes and related diseases and disorders

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- Number: US 10,869,718 B2
- Document ID: US10869718B2
- Status: Granted
- Kind: B2
- Application number: 15/406,572
- Filed: 2017-01-13
- Published: 2017-11-23
- Granted: 2020-12-22
- Earliest claimed: 2014-07-15
- Assignees: Fractyl Laboratories, Inc.
- Applicants: Fractyl Laboratories, Inc.
- Inventors: Harith Rajagopalan; Jay Caplan; Craig M. Gardner; J. Christopher Flaherty
- Web page: https://patentgrep.com/patent/US10869718B2

## CPC

- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 18/04: by heating (by applying electromagnetic radiation A61B18/18)
- A61B 18/06: caused by chemical reaction {, e.g. moxaburners}
- A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)}
- A61B 2018/00029: {open}
- A61B 2018/00196: {reciprocating lengthwise}
- A61B 2018/0022: {Balloons}
- A61B 2018/00238: {porous}
- A61B 2018/00404: {Blood vessels other than those in or around the heart}
- A61B 2018/0041: {Removal of thrombosis}
- A61B 2018/00494: {Stomach, intestines or bowel}
- A61B 2018/00577: {Ablation}
- A61B 2018/00779: {Power or energy}
- A61B 2018/00797: {measured by multiple temperature sensors}
- A61B 2018/00839: {Bioelectrical parameters, e.g. ECG, EEG}
- A61B 2018/00875: {Resistance or impedance}
- A61B 2018/00994: {combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound}
- A61B 2018/044: {the surgical action being effected by a circulating hot fluid}
- A61B 2018/1467: {using more than two electrodes on a single probe}
- A61M 2025/0087: {Multiple injection needles protruding laterally from the distal tip}
- A61M 2025/1052: {for temporarily occluding a vessel for isolating a sector}
- 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

Systems, device and methods treat target tissue to provide a therapeutic benefit to the patient. A tissue treatment device comprises a tissue treatment element constructed and arranged to treat target tissue, such as duodenal mucosa tissue.

## Claims

### Claim 1

A method of treating target tissue to provide a therapeutic benefit to a patient with type 2 diabetes, the method comprising:
providing a tissue treatment device comprising a tissue treatment element constructed and arranged to treat target tissue by ablation, wherein the target tissue comprises at least duodenal mucosal tissue;
advancing the tissue treatment device into the intestine of the patient; and
treating a cumulative length of at least 4 cm but less than all of duodenal mucosal tissue to provide the therapeutic benefit to the patient, wherein treating comprises ablating the duodenal mucosal tissue;
wherein the treated cumulative length of duodenal mucosal tissue has a proximal most edge which is located in a region between 1 cm distal to the ampulla of Vater and 3 cm distal to the ampulla of Vater.

### Claim 2 (depends on 1)

The method according to claim 1, wherein greater than 6 cm of duodenal mucosal tissue is treated.

### Claim 3 (depends on 1)

The method according to claim 1, wherein greater than 7 cm of duodenal mucosal tissue is treated.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the treating of the cumulative length of at least 4 cm of duodenal mucosal tissue comprises performing a first treatment at a first location in the intestine, and performing a second treatment at a second location in the intestine.

### Claim 5 (depends on 4)

The method according to claim 4, wherein the second treatment is performed after the first treatment.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the therapeutic benefit comprises a reduction of HbA1c of at least 0.5%.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the therapeutic benefit comprises a reduction of HbA1c of at least 0.7%.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the therapeutic benefit comprises achieving a fasting plasma glucose less than or equal to 150 mg/dl.

### Claim 9 (depends on 1)

The method according to claim 1, wherein the therapeutic benefit comprises reducing fasting plasma glucose by at least 63.5 mg/dl.

### Claim 10 (depends on 1)

The method according to claim 1, wherein the therapeutic benefit comprises an improvement in quality of life of at least 3 points as measured by an SF-36 Health Survey.

### Claim 11 (depends on 1)

The method according to claim 1, wherein the therapeutic benefit comprises a weight loss of at least 3 kg.

### Claim 12 (depends on 1)

The method according to claim 1, further comprising managing the patient's diet after treating the duodenal mucosal tissue.

### Claim 13 (depends on 1)

The method according to claim 1, further comprising marking of tissue proximate non-target tissue, the marking performed prior to the treating of the duodenal mucosal tissue.

### Claim 14 (depends on 13)

The method according to claim 13, wherein the non-target tissue comprises the ampulla of Vater.

### Claim 15 (depends on 13)

The method according to claim 13, wherein the treating of the duodenal mucosal tissue is performed at a location based on the marking.

### Claim 16 (depends on 1)

The method according to claim 1, further comprising a performing full circumferential tissue expansion procedure prior to the treating of the duodenal mucosal tissue.

### Claim 17 (depends on 1)

The method according to claim 1, further comprising performing a tissue expansion procedure prior to the treating of the duodenal mucosal tissue, wherein the treating of the duodenal mucosal tissue is performed within 60 minutes of the tissue expansion procedure.

### Claim 18

The method according to 1, wherein the cumulative length is treated by performing three or more ablations of the duodenum.