# US 10,307,279 B2 · Ingestible delivery systems and methods

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- Number: US 10,307,279 B2
- Document ID: US10307279B2
- Status: Granted
- Kind: B2
- Application number: 15/818,482
- Filed: 2017-11-20
- Published: 2018-03-15
- Granted: 2019-06-04
- Earliest claimed: 2012-02-21
- Assignees: Allurion Technologies, Inc.
- Applicants: Allurion Technologies, Inc.
- Inventors: Jonathan Wecker; Shantanu K. Gaur; Bruce A. Horwitz; Samuel G. Levy
- Web page: https://patentgrep.com/patent/US10307279B2

## CPC

- A61F 5/0036: {Intragastrical devices}
- A61B 17/12131: {characterised by the type of occluding device}
- A61F 5/003: {inflatable}
- A61M 31/002: {Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time (artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50)}
- A61M 2025/1054: {having detachable or disposable balloons}
- 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)
- 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

Methods, devices and systems for delivering a device assembly using a shaped body allowing for ease of ingestion of a gastric device into a gastric space, allowing the gastric device to expand to occupy volume within the gastric space and, after an effective period of time release from the body.

## Claims

### Claim 1

An ingestible delivery system for ingestion of an object by a patient, the delivery system comprising:
a dosage shape having the object embedded therein to facilitate delivery of the object into the gastric space of the patient, where the dosage shape extends away from the object with bi-lateral symmetry to prevent the patient from sensing the object during ingestion, the dosage shape having a length along a first axis between a proximal end and a distal end, where the length is greater than a width of the dosage shape, a first surface and a second surface disposed on opposing sides of a plane of bi-lateral symmetry, a thickness between the first surface and the second surface, the first and second surfaces being smoothly continuous between the proximal end and distal end;
a bulge region on the first surface of the dosage shape, where the bulge region comprises a maximum thickness of the dosage shape;
a proximal tapering surface on the first surface that tapers from the bulge region to the proximal end such that a proximal thickness of the dosage shape decreases along the first axis towards the proximal end;
a distal tapering surface on the first surface that tapers from the bulge region to the distal end, such that a distal thickness of the dosage shape decreases along the first axis where a length of the proximal tapering surface is less than a length of the distal tapering surface; and
where the dosage shape comprises a degradable material that is degradable in the gastric space allowing for release of the object subsequent to ingestion.

### Claim 2 (depends on 1)

The ingestible delivery system of claim 1, where the second surface is shallowly elliptically convex.

### Claim 3 (depends on 2)

The ingestible delivery system of claim 2, where the shallowly elliptically convex second surface comprises a trough that is parallel to the first axis and that extends from the proximal end to the distal end.

### Claim 4 (depends on 1)

The ingestible delivery system of claim 1, where the distal end is bulbous.

### Claim 5 (depends on 1)

The ingestible delivery system of claim 1, where the proximal end comprises a flat surface to permit a tongue of the patient to push the dosage shape.

### Claim 6 (depends on 1)

The ingestible delivery system of claim 1, further comprising a smooth surface texture.

### Claim 7 (depends on 1)

The ingestible delivery system of claim 1 wherein the first surface comprises two laterally symmetric surfaces adapted to match a roof of a mouth of the patient in the vicinity of the junction between the hard and soft palate of the patient.

### Claim 8 (depends on 1)

The ingestible delivery system of claim 1, wherein the dosage shape comprises a lubricious surface.

### Claim 9 (depends on 1)

The ingestible delivery system of claim 1, where the dosage shape comprises a coefficient of friction that decreases when lubricated.

### Claim 10 (depends on 1)

The ingestible delivery system of claim 1, where dosage shape further includes a liquid impermeable material.

### Claim 11 (depends on 1)

The ingestible delivery system of claim 1, where the dosage shape is at least partially elastically deformable in response to pressure.

### Claim 12 (depends on 1)

The ingestible delivery system of claim 1 where the object comprises a reduced profile with a volume greater than 1.4 ml.

### Claim 13 (depends on 1)

The ingestible delivery system of claim 1, where a thickness of the degradable material around the object is at least 1 millimeter.

### Claim 14 (depends on 1)

The ingestible delivery system of claim 1, where the width is between 8 and 35 millimeters.

### Claim 15

An ingestible delivery system for ingestion by a patient, the delivery system comprising:
a dosage shape encasing an object for delivery into the gastric space of the patient, where the dosage shape comprises a top surface that tapers from a bulge region along both a first axis and a second axis to form an arch shape configured to substantially conform to a palatal arch of the patient, where a first region along the top surface distal from the bulge region comprises a length greater than a length of a second region that is proximal relative to the bulge region;
the dosage shape comprising a bottom surface opposite to the top surface and having a shallow convex surface being smoothly continuous and extending along a length of the dosage shape, where the top surface and bottom surface combine to reduce a swallowing resistance by mimicking a large bolus of food as formed by a mouth of the patient just prior to initiating swallowing; and
where the dosage shape comprises a degradable material that is degradable in the gastric space allowing for release of the object subsequent to ingestion, where the degradable material surrounds the object to prevent the patient from sensing the object during ingestion.

### Claim 16 (depends on 15)

The ingestible delivery system of claim 15, where the bottom surface is shallowly elliptically convex.

### Claim 17 (depends on 16)

The ingestible delivery system of claim 16, where the shallowly elliptically convex second surface comprises a trough that is parallel to a center axis of the dosage shape that extends from a proximal end to a distal end.

### Claim 18 (depends on 17)

The ingestible delivery system of claim 17, where the distal end is bulbous.

### Claim 19 (depends on 17)

The ingestible delivery system of claim 17, where the proximal end comprises a flat surface to permit a tongue of the patient to push the dosage shape.

### Claim 20 (depends on 15)

The ingestible delivery system of claim 15, further comprising a smooth surface texture.
