# US 11,318,008 B2 · Gastrointestinal implant delivery systems and methods

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- Number: US 11,318,008 B2
- Document ID: US11318008B2
- Status: Granted
- Kind: B2
- Application number: 16/073,652
- Filed: 2017-01-30
- Published: 2021-07-08
- Granted: 2022-05-03
- Earliest claimed: 2016-01-29
- Assignees: GI Dynamics, Inc.
- Applicants: GI Dynamics, Inc.
- Inventors: Nicholas Cote; Ryan Hanlon; Ronald B. Lamport; Barry Maxwell; John Panek; Ian K. Parker; Scott Schorer; Nicholas Williams
- Web page: https://patentgrep.com/patent/US11318008B2

## CPC

- A61F 2/04: Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts (A61F2/18, A61F2/20 take precedence; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95)
- A61F 2/07: Stent-grafts
- A61F 2/95: Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F 5/0076: {preventing normal digestion, e.g. Bariatric or gastric sleeves}
- A61F 5/0089: {Instruments for placement or removal}
- A61B 17/0469: {Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery}
- A61B 2017/00292: {mounted on or guided by flexible, e.g. catheter-like, means}
- A61B 2017/22038: {with a guide wire}
- A61B 2017/22041: {outside the catheter}
- A61F 2002/045: {Stomach, intestines}
- A61F 2002/9511: {the retaining means being filaments or wires}
- A61F 2220/0008: Fixation appliances for connecting prostheses to the body
- A61F 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes
- A61F 2220/0025: Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

The present invention provides delivery systems for positioning a gastrointestinal implant in a patient, for example, for treatment of a metabolic disease. Also provided are methods for assembling the delivery systems, methods of positioning a gastrointestinal implant, and methods of treatment of metabolic diseases, such as type 2 diabetes, non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease (NAFLD), obesity, and related comorbidities thereof.

## Claims

### Claim 1

A delivery system for placing a gastrointestinal implant in a gastrointestinal tract of a patient, the delivery system comprising:
(a) a delivery catheter comprising a lumen;
(b) a container assembly at the distal portion of the delivery catheter, the container assembly comprising a proximal capsule and a distal cap removably attachable thereto; and
(c) a gastrointestinal implant comprising: (i) a sleeve configured to carry fluid from its proximal end to its distal end; and (ii) an anchor connected to the sleeve at or near its proximal end, the anchor configured to secure the proximal end of the sleeve within the gastrointestinal tract;
wherein the gastrointestinal implant is configured to fit within the container assembly such that the anchor fits within the proximal capsule and a portion of the sleeve fits within the distal cap and
wherein the container assembly further comprises an anchor locking mechanism within the proximal capsule.

### Claim 2 (depends on 1)

The delivery system of claim 1, wherein the container assembly further comprises an ejection mechanism.

### Claim 3 (depends on 1)

The delivery system of claim 1, wherein the anchor is configured to be positioned distal to the patient's pylorus.

### Claim 4

A method of positioning a gastrointestinal implant in a patient, the method comprising the steps of:
(a) providing a container assembly containing a gastrointestinal implant, the gastrointestinal implant comprising a proximal anchor and an elongate distal portion, wherein the container assembly comprises:
(i) a proximal capsule containing the proximal portion of the gastrointestinal implant,
(ii) a distal cap containing all or part of the elongate distal portion; and
(iii) an anchor locking mechanism within the proximal capsule;
(b) directing the container assembly into the patient's gastrointestinal tract;
(c) securing the proximal anchor to a luminal wall of the gastrointestinal tract; and
(d) allowing peristalsis to extend the elongate distal portion;
thereby positioning the gastrointestinal implant.

### Claim 5 (depends on 4)

The method of claim 4, wherein step (c) is initiated by ejecting the gastrointestinal implant and the distal cap from the proximal capsule.

### Claim 6

A method of positioning a gastrointestinal implant in a patient, the method comprising the steps of:
(a) providing a container assembly containing a gastrointestinal implant, the gastrointestinal implant comprising a proximal anchor and an elongate distal portion, wherein the container assembly comprises:
(i) a proximal capsule containing the proximal portion of the gastrointestinal implant,
(ii) a distal cap containing all or part of the elongate distal portion; and
(iii) an anchor locking mechanism within the proximal capsule;
(b) directing the container assembly into the patient's gastrointestinal tract;
(c) ejecting the proximal anchor from the proximal capsule while the elongate distal portion is retained within the distal cap; and
(d) allowing:
(i) the proximal anchor to secure to a luminal wall of the gastrointestinal tract; and
(ii) peristalsis to extend the elongate distal portion;
thereby positioning the gastrointestinal implant in the patient.

### Claim 7 (depends on 6)

The method of claim 6, wherein step (b) is performed using a delivery catheter.

### Claim 8 (depends on 6)

The method of claim 6, wherein the container assembly further comprises an ejection mechanism.