# US 10,307,236 B2 · Biased artificial sphincter cuff

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- Number: US 10,307,236 B2
- Document ID: US10307236B2
- Status: Granted
- Kind: B2
- Application number: 14/045,224
- Filed: 2013-10-03
- Published: 2014-01-30
- Granted: 2019-06-04
- Earliest claimed: 2008-12-23
- Assignees: Boston Scientific Scimed, Inc.
- Applicants: AMS Research, LLC
- Inventors: Buddy L. Snow
- Web page: https://patentgrep.com/patent/US10307236B2

## CPC

- A61F 2/004: {inflatable}
- 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

A cuff for use an as artificial sphincter includes an inflatable chamber and a backing. The inflatable chamber includes opposing inside and outside surfaces and inflated and deflated states. The backing is adjacent the outside surface of the chamber. The inside surface of the chamber includes two or more grooves that define the location of fold lines of the inflatable chamber when the inflatable chamber is in the inflated state. The inflatable chamber and backing are configured to surround a duct of a patient with the inside surface of the chamber facing the duct and the grooves extending substantially parallel to the duct.

## Claims

### Claim 1

A cuff for use as an artificial sphincter around a duct of a patient, the cuff comprising:
an inflatable chamber having an inside surface, an outside surface opposite the inside surface, an inflated state, and a deflated state, the inflatable chamber having a first end portion and a second end portion, the first end portion being coupled to the second end portion when the cuff is installed around the duct of the patient;
a backing adjacent the outside surface of the inflatable chamber; and
a biasing mechanism including two or more grooves, wherein the grooves predefine the location of fold lines of the inflatable chamber, at which the inflatable chamber will fold upon itself when the inflatable chamber is in the inflated state, wherein the inflatable chamber and the backing are configured to surround the duct of the patient with the inside surface of the inflatable chamber facing the duct and the grooves extending substantially parallel to the duct,
wherein the backing includes a flexible member, a first elongated reinforcing member attached to the flexible member, and a second elongated reinforcing member attached to the flexible member, at least one groove being disposed between the first elongated reinforcing member and the second elongated reinforcing member, wherein the first elongated reinforcing member and the second elongated reinforcing member are disposed on an outer surface of the flexible member, wherein the first elongated reinforcing member and the second elongated reinforcing member are disposed apart from each other along a longitudinal axis of the backing at locations between the first end portion of the inflatable chamber and the second end portion of the inflatable chamber, the first elongated reinforcing member having a length that extends substantially parallel to the at least one groove, the second elongated reinforcing member having a length that extends substantially parallel to the at least one groove.

### Claim 2 (depends on 1)

The cuff of claim 1, wherein the grooves include two grooves configured to bias the cuff into a triangular shape when installed around the duct.

### Claim 3 (depends on 1)

The cuff of claim 1, wherein the grooves include three grooves, each configured to define a fold line in the inflatable chamber when the inflatable chamber is in the inflated state.

### Claim 4 (depends on 1)

The cuff of claim 1, wherein the grooves include five grooves.

### Claim 5 (depends on 1)

The cuff of claim 1, wherein the grooves include ten grooves on the inside surface.

### Claim 6 (depends on 1)

The cuff of claim 1, wherein the grooves include 0.2-20 grooves per centimeter.

### Claim 7 (depends on 1)

The cuff of claim 1, wherein the grooves include at least 0.5 grooves per centimeter.

### Claim 8 (depends on 1)

The cuff of claim 1, wherein the grooves include at least 10 grooves per centimeter.

### Claim 9 (depends on 1)

The cuff of claim 1, wherein the inflatable chamber is attached to the backing.

### Claim 10 (depends on 1)

The cuff of claim 1, wherein the first elongated reinforcing member is formed of a silicone elastomer reinforced with polyester yarn.

### Claim 11 (depends on 1)

The cuff of claim 1, wherein the flexible member includes a first surface and a second surface opposite to the first surface, the first surface of the flexible member being coupled to the inflatable chamber, the second surface of the flexible member being coupled to the first reinforcing member and the second reinforcing member.

### Claim 12 (depends on 1)

The cuff of claim 1, wherein the first reinforcing member and the second reinforcing member are disposed between the flexible member and the inflatable member.

### Claim 13

An artificial sphincter system for controlling a flow through a duct of a patient, the system comprising:
a balloon;
a cuff comprising:
an inflatable chamber having an inside surface, an outside surface opposite the inside surface, an inflated state, and a deflated state, the inflatable chamber having a first end portion and a second end portion, the first end portion being coupled to the second end portion when the cuff is installed around the duct of the patient;
a backing adjacent the outside surface of the inflatable chamber; and
a biasing mechanism including two or more grooves, wherein the grooves predefine the location of fold lines of the inflatable chamber, at which the inflatable chamber will fold upon itself when the inflatable chamber is in the inflated state, wherein the inflatable chamber and the backing are configured to surround the duct of the patient with the inside surface of the inflatable chamber facing the duct and the grooves extending substantially parallel to the duct,
wherein the backing includes a flexible member, a first elongated reinforcing member attached to the flexible member, and a second elongated reinforcing member attached to the flexible member, at least one groove being disposed between the first elongated reinforcing member and the second elongated reinforcing member, wherein the first elongated reinforcing member and the second elongated reinforcing member are disposed on an outer surface of the flexible member, wherein the first elongated reinforcing member and the second elongated reinforcing member are disposed apart from each other along a longitudinal axis of the backing at locations between the first end portion of the inflatable chamber and the second end portion of the inflatable chamber, the first elongated reinforcing member having a length that extends substantially parallel to the at least one groove, the second elongated reinforcing member having a length that extends substantially parallel to the at least one groove; and
a control pump fluidically coupled to the balloon and the cuff.

### Claim 14 (depends on 13)

The system of claim 13, wherein:
the balloon pressurizes fluid in the cuff and biases the cuff in the inflated state; and
the control pump is configured to drive a flow of fluid out of the cuff and into the balloon to deflate the cuff.

### Claim 15 (depends on 13)

The system of claim 13, wherein the grooves include two grooves configured to bias the cuff into a triangular shape when installed around the duct.

### Claim 16 (depends on 13)

The system of claim 13, wherein the grooves include three grooves, each configured to define a fold line in the inflatable chamber when the inflatable chamber is in the inflated state.

### Claim 17 (depends on 13)

The system of claim 13, wherein the grooves include five grooves.

### Claim 18 (depends on 13)

The system of claim 13, wherein the grooves include 0.2-20 grooves per centimeter.

### Claim 19 (depends on 13)

The system of claim 13, wherein the inflatable chamber is attached to the backing.

### Claim 20 (depends on 13)

The cuff of claim 13, wherein the flexible member includes a first surface and a second surface opposite to the first surface, the first surface of the flexible member being coupled to the inflatable chamber, the second surface of the flexible member being coupled to the first elongated reinforcing member and the second elongated reinforcing member.
