# US 11,026,825 B2 · Methods, devices, and systems for obesity treatment

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- Number: US 11,026,825 B2
- Document ID: US11026825B2
- Status: Granted
- Kind: B2
- Application number: 16/199,063
- Filed: 2018-11-23
- Published: 2019-06-27
- Granted: 2021-06-08
- Earliest claimed: 2004-11-19
- Assignees: Fulfillium, Inc.
- Applicants: Fulfillium, Inc.
- Inventors: Richard D. Y. Chen; Craig A. Johanson; Christopher S. Jones; Reinhold H. Dauskardt; Marc B. Taub
- Web page: https://patentgrep.com/patent/US11026825B2

## CPC

- A61F 5/0033: {with more than one chamber}
- A61B 5/0028: {Body tissue as transmission medium, i.e. transmission systems where the medium is the human body}
- A61B 5/076: {Permanent implantation}
- A61B 5/686: {Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence)}
- A61B 5/7282: {Event detection, e.g. detecting unique waveforms indicative of a medical condition (cough events A61B5/0823; seizures A61B5/4094; sleep apnoea A61B5/4818)}
- A61B 5/746: {Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms}
- A61F 2/12: Mammary prostheses
- A61F 5/003: {inflatable}
- A61F 5/0036: {Intragastrical devices}
- A61F 5/0046: {with wireless means}
- A61N 1/08: Arrangements or circuits for monitoring, protecting, controlling or indicating {(for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925)}
- A61N 1/372: Arrangements in connection with the implantation of stimulators
- G08B 21/18: Status alarms (G08B21/02 takes precedence)
- A61B 2560/0276: Determining malfunction
- A61F 2210/0061: swellable
- A61F 2250/0002: for data transfer
- A61F 2250/0003: having an inflatable pocket filled with fluid, e.g. liquid or gas
- A61F 2250/008: Alarm means
- 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)
- 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)
- G08B: SIGNALLING SYSTEMS, e.g. PERSONAL CALLING SYSTEMS; ORDER TELEGRAPHS; ALARM SYSTEMS

## Abstract

In one aspect, an obesity treatment device includes multiple inflatable space-filling compartments and a valve system for introducing fluid into each compartment, where the device forms, upon filing the compartments, to a curved shape conforming to a natural three-dimensional kidney shape of the stomach. In one aspect, a method for deploying a gastric balloon structure in a gastric cavity includes determining dimensions of the gastric cavity in a feeding state, selecting a fill volume for each of a number of isolated chambers of the balloon structure, and filling each chamber while the balloon structure is in the gastric cavity. In one aspect, a system for treating obesity includes a means for conforming a flexible, space-filling structure to a natural kidney shape of the gastric cavity, a means for maintaining at least two isolated inflatable regions of the flexible, space-filling structure, and a means for introducing fluid into each inflatable region.

## Claims

### Claim 1

A system for obesity treatment, comprising:
an obesity treatment apparatus comprising at least two expandable balloons, wherein
each balloon of the at least two expandable balloons comprises an inflation valve,
the obesity treatment apparatus is configured for delivery via an esophagus of a patient in an uninflated state, and
upon inflation, each balloon of the at least two expandable balloons is configured to occupy a respective volume in a stomach of the patient; and
an inflation apparatus comprising
an inflation catheter releasably securable to the inflation valve of each balloon of the at least two expandable balloons for inflating the respective balloon in the stomach of the patient, and
an external pressurized fluid source for coupling to the inflation catheter, wherein
one or more gasses of the external pressurized fluid source are selected to provide buoyancy to the obesity treatment apparatus within the stomach, and
each balloon of the at least two expandable balloons is filled with a same one or more gasses;
wherein, after inflating each expandable balloon with the one or more gasses through the inflation catheter using the pressurized fluid source and releasing the inflation catheter from the respective balloon,
the obesity treatment apparatus is configured to float freely within the stomach of the patient without exerting pressure at any point in the stomach sufficient to cause ulceration, and
the at least two expandable balloons arrange along a curved shape conforming to a natural three-dimensional kidney shape of the stomach such that the at least two expandable balloons are configured to align against greater or lesser curvatures of the stomach.

### Claim 2 (depends on 1)

The system of claim 1, wherein a respective fluid volume for filling each compartment of a plurality of inflatable space-filling compartments is configured to leave in the stomach a residual volume proximal to the obesity treatment apparatus unoccupied by the obesity treatment apparatus during a resting state of the stomach, wherein the residual volume is 10 ml to 100 ml.

### Claim 3 (depends on 2)

The system of claim 2, wherein a first gas of the one or more gasses is nitrogen.

### Claim 4 (depends on 1)

The system of claim 1, wherein the at least two expandable balloons comprise three expandable balloons.

### Claim 5 (depends on 1)

The system of claim 1, wherein the obesity treatment apparatus is removable through the esophagus of the patient after deflation.

### Claim 6 (depends on 5)

The system of claim 5, further comprising a grasping tool for removing the obesity treatment apparatus through the esophagus of the patient.

### Claim 7 (depends on 1)

The system of claim 1, wherein each balloon of the at least two expandable balloons comprises a wall including a layer of polyethylene material.

### Claim 8 (depends on 1)

The system of claim 1, wherein the inflation apparatus further comprises a syringe for fluid delivery.

### Claim 9 (depends on 1)

The system of claim 1, wherein the obesity treatment apparatus is configured to maintain an inflated state volume of each of the at least two expandable balloons while deployed in the stomach of the patient without controlled adjustment.

### Claim 10 (depends on 1)

The system of claim 1, wherein each balloon of the at least two expandable balloons has a major dimension no larger than two centimeters prior to inflation.

### Claim 11 (depends on 1)

The system of claim 1, wherein the inflation valve comprises a self-sealing one-way valve.

### Claim 12

A system for obesity treatment, comprising:
a space-occupying balloon subsystem configured for delivery via an esophagus of a patient and inflation after placement within a gastric cavity of the patient, wherein
the space-occupying balloon system comprises two or more inflatable gastric balloons, each balloon of the two or more inflatable gastric balloons comprising a respective inflation lumen, wherein,
prior to the inflation via the inflation lumen, each balloon of the two or more inflatable gastric balloons has a major dimension no larger than two centimeters; and
an inflation subsystem comprising
an inflation tube releasably attachable to the inflation lumen of each balloon of the two or more inflatable gastric balloons for inflating the respective balloon in the gastric cavity of the patient, and
a fluid delivery apparatus for coupling to the inflation tube, wherein at least one gas is delivered to each balloon of the two or more inflatable gastric balloons via the fluid delivery apparatus, wherein the at least one gas is selected to provide buoyancy for floatation of the two or more inflatable gastric balloons within the gastric cavity;
wherein, after the inflation,
the two or more inflatable gastric balloons arrange along a generally kidney shaped curve such that the two or more inflatable gastric balloons are configured to align against the greater or lesser curvatures of the gastric cavity, and
each balloon of the two or more inflatable gastric balloons is released from the inflation tube such that each balloon of the two or more inflatable gastric balloons is configured to float untethered within the gastric cavity of the patient.

### Claim 13 (depends on 12)

The system of claim 12, wherein each balloon of the at least two expandable balloons comprises a wall including two or more layers, wherein a first layer of the two or more layers is an elastic material.

### Claim 14 (depends on 13)

The system of claim 13, wherein the two or more layers are bonded to one another.

### Claim 15 (depends on 12)

The system of claim 12, wherein the at least one gas comprises nitrogen.

### Claim 16 (depends on 12)

The system of claim 12, wherein the two or more inflatable gastric balloons comprise three expandable balloons.

### Claim 17 (depends on 12)

The system of claim 12, wherein the space-occupying balloon subsystem is removable through the esophagus of the patient after deflation.

### Claim 18 (depends on 17)

The system of claim 17, further comprising a grasping tool for removing the space-occupying balloon subsystem through the esophagus of the patient.

### Claim 19 (depends on 12)

The system of claim 12, wherein the inflation subsystem further comprises a syringe for fluid delivery.

### Claim 20 (depends on 12)

The system of claim 12, wherein each inflation lumen comprises a self-sealing one-way valve.

### Claim 21

A system for obesity treatment, comprising:
an obesity treatment apparatus comprising
at least two expandable balloons, wherein each balloon of the at least two expandable balloons comprises a means for receiving and retaining one or more gasses, and
a means for conforming the obesity treatment apparatus, in an inflated state, to a natural three-dimensional kidney shape of the stomach, wherein
the obesity treatment apparatus is configured for delivery via an esophagus of a patient in an uninflated state, and
upon inflation, each balloon of the at least two expandable balloons is configured to occupy a respective volume in a stomach of the patient; and
an inflation apparatus comprising
an inflation catheter releasably securable to the means for receiving and retaining the one or more gasses of each balloon of the at least two expandable balloons for inflating the respective balloon in the stomach of the patient, and
an external pressurized fluid source for coupling to the inflation catheter, wherein
one or more gasses of the external pressurized fluid source are selected to provide buoyancy to the obesity treatment apparatus within the stomach, and
each balloon of the at least two expandable balloons is filled with a same one or more gasses;
wherein, after inflating each expandable balloon with the one or more gasses through the inflation catheter using the pressurized fluid source and releasing the inflation catheter from the respective balloon,
the obesity treatment apparatus is configured to float freely within the stomach of the patient without exerting pressure at any point in the stomach sufficient to cause ulceration.

### Claim 22 (depends on 21)

The system of claim 21, wherein the means for receiving and retaining the one or more gasses comprises a self-sealing one-way valve.
