# US 10,441,396 B2 · Urethral plug and system for addressing urinary incontinence

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- Number: US 10,441,396 B2
- Document ID: US10441396B2
- Status: Granted
- Kind: B2
- Application number: 15/683,124
- Filed: 2017-08-22
- Published: 2019-02-28
- Granted: 2019-10-15
- Earliest claimed: 2017-08-22
- Assignees: Life360 Innovations Inc.
- Applicants: Life360 Innovations Inc.
- Inventors: Kenneth Kunz; Robert Mitchell Orr; Thom Bellaire; Nigel Halsted; Ernie Janzen
- Web page: https://patentgrep.com/patent/US10441396B2

## CPC

- A61F 2/0009: {placed in or outside the body opening close to the surface of the body (plugging an opening in the wall of a hollow or tubular organ A61B17/0057)}
- A61F 2210/0071: thermoplastic
- A61F 2230/0067: conical
- A61F 2230/0091: helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
- A61F 2230/0093: Umbrella-shaped, e.g. mushroom-shaped
- A61F 2250/0039: differing in diameter
- A61F 2250/0059: temporary
- A61F 2250/0069: Sealing means
- A61F 2250/0078: Gender-specific, e.g. different for male and female patients
- 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 urethral plug having a plug body, a lanyard and a stopper. The plug body having a leading end shaped to spread tissue at the urethral, a central portion; a trailing end tapering down from the central portion, and a sealing ring encircling the central portion. The plug body is shaped so that when positioned within the urethra the plug body is retained within the urethra, to restrict urine flow within the urethra past the plug body.

## Claims

### Claim 1

A urethral plug for insertion in a urethra of a male subject, the device comprising:
a plug body, wherein the plug body comprises:
a leading end shaped to spread tissue of the urethra upon insertion into the urethra of the male subject;
a central bulbous portion;
a trailing end tapering down from the central portion, the central portion disposed between the leading end and the trailing end;
a sealing ring encircling the central bulbous portion at an intersection location between the trailing end and the central portion;
a lanyard having a first end and a second end, the first end coupled to the trailing end of the plug body, and
wherein the plug body is shaped such that when positioned within the urethra the plug body is retained within the urethra, to restrict urine flow within the urethra past the plug body.

### Claim 2 (depends on 1)

The urethral plug of claim 1, further comprising a stopper coupled to the second end of the lanyard wherein, when the device is in situ, a portion of the lanyard and the stopper are located outside a user.

### Claim 3 (depends on 2)

The urethral plug of claim 2, wherein the plug body, the lanyard, and the stopper are a unitary body of continuous material.

### Claim 4 (depends on 2)

The urethral plug of claim 2, wherein the plug body, the lanyard, and the stopper comprise a thermoplastic polymer.

### Claim 5 (depends on 4)

The urethral plug of claim 4, wherein the thermoplastic polymer has durometer hardness of between 50 and 90.

### Claim 6 (depends on 1)

The urethral plug of claim 1, wherein the plug body has an outer surface enabling development of friction between the outer surface and a wall of a user's urethra, when the device is in situ, to maintain position of the urethral plug.

### Claim 7 (depends on 1)

The urethral plug of claim 1, wherein the plug body comprises a hydrophilic material.

### Claim 8 (depends on 1)

The urethral plug of claim 1, wherein the plug body has a surface finish ranging from B-1 to C-3.

### Claim 9 (depends on 1)

The urethral plug of claim 1, further comprising a tab extending from the trailing end of the plug body to constrain and align the urethral plug within an associated inserter.

### Claim 10 (depends on 1)

The urethral plug of claim 1, wherein the plug body is dimensioned so as to be completely contained within the user's urethra when the device is in situ.

### Claim 11 (depends on 1)

The urethral plug of claim 1, wherein the plug body has limited bend or flex.

### Claim 12 (depends on 1)

The urethral plug of claim 1, wherein the plug body is non-hollow.

### Claim 13 (depends on 1)

The urethral plug of claim 1, wherein the lanyard and plug body have an internal channel configured to hold an internal inserter.

### Claim 14 (depends on 1)

The urethral plug of claim 1, wherein the central portion of the plug body is bulbous with a fixed maximum diameter of 3 to 15 mm.

### Claim 15 (depends on 1)

The urethral plug of claim 1, wherein a maximum diameter of the trailing end is greater than a maximum diameter of the lanyard.

### Claim 16

A reusable urethral plug for insertion and removal from a urethra of a male subject, the device comprising:
a plug body, wherein the plug body comprises:
a leading end shaped to spread tissue of the urethra upon insertion into the urethra of the male subject;
a central bulbous portion;
a trailing end tapering down from the central portion, the central portion disposed between the leading end and the trailing end;
a sealing ring encircling the central bulbous portion at an intersection location between the trailing end and the central portion;
a lanyard having a first end and a second end, the first end coupled to the trailing end of the plug body, and
wherein the plug body is shaped such that when positioned within the urethra the plug body is retained within the urethra, to restrict urine flow within the urethra past the plug body, wherein the urethral plug is configured for repeated insertion and removal from the urethra for reuse.

### Claim 17 (depends on 1)

A method of controlling urinary incontinence comprising:
introducing the urethral plug of claim 1 into a urethra of a male subject; and positioning the urethral plug in the male subject's urethra.
