# US 2014/0155807 A1 · Intestinal brake inducing intraluminal therapeutic substance eluting devices and methods

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- Number: US 2014/0155807 A1
- Document ID: US20140155807A1
- Status: Published application
- Kind: A1
- Application number: 14/100,218
- Filed: 2013-12-09
- Published: 2014-06-05
- Earliest claimed: 2010-05-26
- Assignees: Ethicon Endo-Surgery, Inc.
- Applicants: Ethicon Endo-Surgery, Inc.
- Inventors: Thomas E. Albrecht; Jeffrey L. Aldridge; Sean P. Conlon; Michael S. Cropper; Denzel Z. Herrera-Davis; Daniel F. Dlugos; Jason L. Harris; Christopher J. Hess; Thomas W. Huitema; John W. Hunt; Prasanna Malaviya; Mark S. Ortiz; Mark D. Overmyer; Alessandro Pastorelli; Galen C. Robertson; Frederick E. Shelton, IV; Michael J. Stokes; Foster B. Stulen; James W. Voegele; William B. Weisenburgh, II; Christopher W. Widenhouse; Tamara S. Vetro Widenhouse; James A. Woodard, JR.; David C. Yates; Mark S. Zeiner; Andrew M. Zwolinksi
- Web page: https://patentgrep.com/patent/US20140155807A1

## CPC

- A61F 5/0076: {preventing normal digestion, e.g. Bariatric or gastric sleeves}
- 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 5/0013: {Implantable devices or invasive measures}
- A61F 5/0026: {Anti-eating devices using electrical stimulation}
- A61F 5/0079: {Pyloric or esophageal obstructions}
- A61F 2002/045: {Stomach, intestines}
- 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)

## Abstract

Methods and devices create an intestinal braking effect, are non-invasive or minimally invasive, and may be reversible. These methods and devices are accomplished via stabilized implantable systems, and ingestible pills. In one embodiment, the implantable system comprises a device delivering a therapeutic substance to a target location within the gastrointestinal tract of a patient in order to initiate an intestinal braking effect which would promote sensations of satiety and stimulate excess weight loss for the patient.

## Claims

### Claim 1

A device for implantation within a gastrointestinal tract of a patient, said device comprising an expandable tubular member, said tubular member comprising a pH sensitive substance which changes a size of said tubular member in reaction to changes in pH levels within said gastrointestinal tract of said patient.

### Claim 2 (depends on 1)

The device of claim 1, wherein said tubular member is capable of eluting a therapeutic substance to cause an intestinal brake effect, wherein said therapeutic substance is eluted by a mechanism selected from pulsation, constant release, and a combination thereof.

### Claim 3 (depends on 1)

The device of claim 1, wherein said wherein said tubular member is capable of eluting a therapeutic substance selected from at least one of fat, glucose, nutrients, hormones, hormone eluting cell stimulants, hormone eluting cell deterrents, pancreatic polypeptide, free fatty acid, cholecystokinin, amino acids, glutamine, lipids, glucagon-like peptide-1, or combinations thereof.

### Claim 4 (depends on 1)

The device of claim 1, wherein said device comprises a swallowable pill device, wherein said pill is selected from a pill with nanochannels, a pressure wave pill, a stomach coating pill, a pill to increase peristalsis, and combinations thereof.

### Claim 5 (depends on 1)

The device of claim 1, wherein said device comprises a swallowable pill comprising nanochannels that allow fluid communication and passage of glucagon-like peptide-1 therethrough and which serve as an enzyme barrier to prevent digestion of therapeutic substances contained within said swallowable pill.

### Claim 6 (depends on 5)

The device of claim 5, wherein said pill comprises layers, wherein said layers are selected from therapeutic-containing layers, non-therapeutic containing layers, and combinations thereof.

### Claim 7 (depends on 1)

The device of claim 1, wherein said device comprises a rechargeable drug eluting reservoir, said reservoir in a form selected from a degradable therapeutic substance infused foam, a semi-permeable membrane capable of releasing a therapeutic substance over time, a hollow cylinder which allows chyme to pass through, and combinations thereof.

### Claim 8 (depends on 1)

The device of claim 1, wherein said device comprises a chyme holding device.

### Claim 9 (depends on 1)

The device of claim 1, wherein said device comprises a fill port and a pressure sensing system.

### Claim 10 (depends on 1)

The device of claim 1, wherein said device is capable of producing pulse waves to stimulate the interaction of chyme with the L cells of the ileum to create an intestinal brake effect.

### Claim 11 (depends on 1)

The device of claim 1, wherein said tubular member is configured to deliver an electrical stimulation to the ileum in the presence of linoleic acid.

### Claim 12 (depends on 1)

The device of claim 1, wherein said tubular member is degradable.

### Claim 13 (depends on 1)

The device of claim 1, wherein said tubular member is positioned in the intestine just past the ileocecal valve.

### Claim 14 (depends on 1)

The device of claim 1, wherein said tubular member is affixed to the wall of the intestine.

### Claim 15 (depends on 1)

The device of claim 1, wherein said tubular member comprises a lubricant.

### Claim 16

A method of inducing satiety comprising
a. implanting a stent within a lumen of a gastrointestinal tract;
b. retaining a portion of chyme that flows by the stent within a body of said stent; and
c. re-releasing the retained chyme from said stent into the gastrointestinal tract at a predetermined rate slower than a rate caused by natural peristalsis.

### Claim 17 (depends on 16)

The method of claim 16 wherein said step of retaining a portion of chyme that flows by the stent within a body of said stent comprises absorbing said chyme within said stent.

### Claim 18 (depends on 16)

The method of claim 16 wherein said step of retaining a portion of chyme that flows by the stent within a body of said stent comprises physically obstructing said chyme within said stent.

### Claim 19 (depends on 16)

The method of claim 16 comprising at least one additional step of the step of:
a. stabilizing said stent without disturbing vascularization of the intestines by performing a procedure selected from creating an artificially formed dead end branch;
b. forming a loop with anastamosis in the intestines; or
c. a combination thereof.

### Claim 20

A method of producing satiety comprising:
a. surgically accessing a gastrointestinal tract of a patient;
b. splitting said tract into a first lumen for passage of nutrients and a second lumen;
c. implanting a device within said second lumen; and
d. eluting a satiety inducing substance from the device into the gastrointestinal tract.
