# US 9,757,535 B2 · Systems, devices and methods for performing medical procedures in the intestine

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- Number: US 9,757,535 B2
- Document ID: US9757535B2
- Status: Granted
- Kind: B2
- Application number: 15/274,764
- Filed: 2016-09-23
- Published: 2017-01-12
- Granted: 2017-09-12
- Earliest claimed: 2014-07-16
- 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/US9757535B2

## CPC

- A61M 25/00: Catheters; Hollow probes (dilators A61M29/00; {peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00} ; for measuring or testing A61B; {materials for catheters A61L29/00})
- A61B 5/0036: {including treatment, e.g., using an implantable medical device, ablating, ventilating}
- A61B 5/0084: {for introduction into the body, e.g. by catheters (A61B5/1459 takes precedence)}
- A61B 5/4255: {Intestines, colon or appendix}
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/6852: {Catheters}
- A61B 5/6885: {Monitoring or controlling sensor contact pressure}
- A61B 17/00234: {for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)}
- A61B 18/02: by cooling, e.g. cryogenic techniques
- A61B 18/082: {Probes or electrodes therefor}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 18/1815: {using microwaves}
- A61F 5/0069: {in the wall of the stomach}
- A61F 5/0079: {Pyloric or esophageal obstructions}
- A61M 25/04: in the body, e.g. expansible {(A61M25/10, A61M16/0488 take precedence)}
- A61N 7/00: Ultrasound therapy (lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 {; using ultrasound for introducing media into the body A61M37/0092})
- A61B 5/0066: {Optical coherence imaging}
- A61B 17/00491: {Surgical glue applicators}
- A61B 17/0218: {for minimally invasive surgery (A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)}
- A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)}
- A61B 18/06: caused by chemical reaction {, e.g. moxaburners}
- A61B 18/24: with a catheter (A61B18/26, A61B18/28 take precedence)
- A61B 2017/00004: {(bio)absorbable, (bio)resorbable or resorptive}
- A61B 2017/00022: {Sensing or detecting at the treatment site}
- A61B 2017/00199: {with a console, e.g. a control panel with a display}
- A61B 2017/00269: {endoscopic mucosal resection EMR}
- A61B 2017/00818: {Treatment of the gastro-intestinal system}
- A61B 2017/306: {holding by means of suction}
- A61B 2018/00005: {Cooling or heating of the probe or tissue immediately surrounding the probe}
- A61B 2018/00011: {with fluids}
- A61B 2018/00017: {with gas}
- A61B 2018/00029: {open}
- A61B 2018/00041: {Heating, e.g. defrosting}
- A61B 2018/0022: {Balloons}
- A61B 2018/00255: {arranged one inside another}
- A61B 2018/00285: {Balloons}
- A61B 2018/00291: {using suction}
- A61B 2018/00494: {Stomach, intestines or bowel}
- A61B 2018/00559: {Female reproductive organs}
- A61B 2018/00577: {Ablation}
- A61B 2018/00642: {with feedback, i.e. closed loop control}
- A61B 2018/00672: {lower}
- A61B 2018/00678: {upper}
- A61B 2018/00744: {Fluid flow}
- A61B 2018/00791: {Temperature}
- A61B 2018/00809: {measured thermochromatically}
- A61B 2018/00815: {measured by a thermistor}
- A61B 2018/00821: {measured by a thermocouple}
- A61B 2018/00839: {Bioelectrical parameters, e.g. ECG, EEG}
- A61B 2018/00863: {Fluid flow}
- 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 2018/0212: {using an instrument inserted into a body lumen, e.g. catheter}
- A61B 2018/046: {in liquid form}
- A61B 2018/1861: {with an instrument inserted into a body lumen or cavity, e.g. a catheter}
- A61B 2090/3908: {Soft tissue, e.g. breast tissue}
- A61B 2090/3933: {Liquid markers}
- A61B 2090/395: {with marking agent for marking skin or other tissue}
- A61B 2218/002: Irrigation
- A61B 2505/05: Surgical care
- A61B 2560/0431: Portable apparatus, e.g. comprising a handle or case
- A61B 2562/227: Sensors with electrical connectors
- A61M 25/0082: {Catheter tip comprising a tool}
- A61M 2210/1053: Stomach
- A61M 2210/1057: Duodenum
- A61M 2210/1071: Liver; Hepar
- A61M 2210/1408: Ovaries
- A61N 7/022: {intracavitary}
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

A method for performing a medical procedure in an intestine of a patient is provided. The method comprises providing a system comprising: a catheter for insertion into the intestine, the catheter comprising: an elongate shaft comprising a distal portion; and a functional assembly positioned on the shaft distal portion and comprising at least one treatment element. The catheter is introduced into the patient, and target tissue is treated with the at least one treatment element. The target tissue comprises mucosal tissue of the small intestine, and the medical procedure can be configured to treat at least one of non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH).

## Claims

### Claim 1

A method for performing a medical procedure in an intestine of a patient, comprising:
selecting a patient diagnosed with at least one of non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH);
providing a system comprising:
a catheter for insertion into the intestine, the catheter comprising:
an elongate shaft comprising a distal portion; and
a functional assembly positioned on the shaft distal portion and comprising at least one treatment element;
introducing the catheter into the patient diagnosed with at least one of NAFLD or NASH; and
treating target tissue with the at least one treatment element, wherein the target tissue comprises mucosal tissue of the patient's small intestine;
wherein the medical procedure is configured to treat the at least one of NAFLD or NASH: and
wherein the patient had elevated baseline levels of aspartate transaminase (AST) and alanine transaminase (ALT) indicative of inflammation of the liver prior to treating the target tissue with the at least one treatment element, the patient achieves a reduction in the elevated baseline levels of AST and ALT after treatment, and the patient achieves the reduction in the levels of AST and ALT by 24 weeks after treatment and sustains the reduction through week 48 after treatment.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the medical procedure is further configured to treat insulin resistance.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the medical procedure is further configured to treat a disease or disorder selected from the group consisting of: Type 2 diabetes; Type 1 diabetes; “Double diabetes”; gestational diabetes; hyperglycemia; pre-diabetes; impaired glucose tolerance; insulin resistance; and combinations thereof.

### Claim 4 (depends on 1)

The method according to claim 1, wherein treating target tissue modifies at least one of nutrient absorption by the target tissue, hormonal signaling from the target tissue, or secretions of the target tissue.

### Claim 5 (depends on 1)

The method according to claim 1, wherein treating target tissue comprises treating mucosal tissue within 15 cm of the patient's ampulla of Vater.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the method comprises avoiding treating tissue between a first location proximate the patient's ampulla of Vater and a second location 0.5 cm distal to the patient's ampulla of Vater.

### Claim 7 (depends on 1)

The method according to claim 1, wherein at least 6 cm of length of the patient's duodenum are treated.

### Claim 8 (depends on 1)

The method according to claim 1, wherein at least 9 cm of length of the patient's duodenum are treated.

### Claim 9 (depends on 1)

The method according to claim 1, wherein treating target tissue comprises treating at least a first axial segment and a second axial segment of the intestine.

### Claim 10 (depends on 1)

The method according to claim 1, wherein treating target tissue comprises treating between two and six axial segments of the intestine to treat at least 6 cm of axial length of intestine.

### Claim 11 (depends on 1)

The method according to claim 1, wherein treating target tissue comprises treating an amount of tissue that is based on the severity of the patient's NAFLD and/or NASH.

### Claim 12 (depends on 1)

The method according to claim 1, further comprising identifying non-target tissue, wherein the non-target tissue is identified by marking tissue selected from the group consisting of: ampulla of Vater; tissue proximate the ampulla of Vater; pylorus; tissue proximate the pylorus; and combinations thereof.

### Claim 13 (depends on 1)

The method according to claim 1, wherein treating target tissue comprises a series of tissue ablation steps, each comprising ablation of an axial length of intestinal tissue, wherein each ablation step is preceded by a tissue expansion step.

### Claim 14 (depends on 13)

The method according to claim 13, further comprising preventing axial motion of the functional assembly between the tissue expansion and the tissue treatment steps.

### Claim 15 (depends on 13)

The method according to claim 13, further comprising applying vacuum to tissue during the tissue expansion step.

### Claim 16 (depends on 1)

The method according to claim 1, wherein treating target tissue comprises a series of tissue ablation steps, each ablation step comprising ablation of an axial length of intestinal tissue, wherein each ablation step is followed by a tissue neutralizing step.

### Claim 17 (depends on 16)

The method according to claim 16, wherein each ablation step comprises a heat ablation of tissue and each neutralizing step comprises a cooling of tissue.

### Claim 18 (depends on 16)

The method according to claim 16, further comprising performing a separate tissue neutralizing step prior to each ablation step.

### Claim 19 (depends on 18)

The method according to claim 18, wherein each ablation step comprises a heat ablation of tissue and each separate neutralizing step comprises a cooling of tissue.

### Claim 20 (depends on 1)

The method according to claim 1, further comprising maintaining the functional assembly at or below a target diameter, a target pressure, or a target volume.

### Claim 21 (depends on 1)

The method according to claim 1, further comprising delivering an anti-peristaltic agent.

### Claim 22 (depends on 1)

The method according to claim 1, further comprising modifying a pressure of a segment of intestine that is proximate the target tissue being treated.

### Claim 23 (depends on 1)

The method according to claim 1, wherein the functional assembly includes a tissue contacting portion comprising a surface area between 500 mm2 and 3500 mm2.

### Claim 24 (depends on 1)

The method according to claim 1, where the functional assembly comprises an expanded diameter between 19 mm and 28 mm.

### Claim 25 (depends on 1)

The method according to claim 1, wherein the patient had at least 3 cm of mucosal tissue treated.

### Claim 26 (depends on 25)

The method according to claim 25, wherein the mucosal tissue comprises duodenal mucosal tissue.

### Claim 27 (depends on 1)

The method according to claim 1, wherein the patient baseline AST level is above 50 mg/dL and is below 40 mg/dl at weeks 24 and 48 after treatment.

### Claim 28 (depends on 1)

The method according to claim 1, wherein the patient baseline ALT level is above 40 mg/dL and is below 30 mg/dl at weeks 24 and 48 after treatment.