# US 2008/0188770 A1 · Device and Method for the Collection of a Urine Sample

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- Number: US 2008/0188770 A1
- Document ID: US20080188770A1
- Status: Published application
- Kind: A1
- Application number: 12/015,912
- Filed: 2008-01-17
- Published: 2008-08-07
- Earliest claimed: 2007-01-29
- Assignees: Hollister Incorporated
- Inventors: David Hannon
- Web page: https://patentgrep.com/patent/US20080188770A1

## CPC

- A61B 10/007: {for taking urine samples (measuring urological functions A61B5/20; genital receptacles A61F5/451; urinals for bed-ridden persons A61G9/006)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A device and method for collection of a urine sample is disclosed which comprises a channel, an opening in the channel, and a collector associated with the opening. The channel is formed so that urine can flow through it from a first end to a second end thereof. The opening is provided in the channel at a point between the first and the second ends thereof. The collector is associated with the opening in the channel to be able to receive urine therein. In one embodiment, a member can cover the opening to permit urine to pass through it after contact with urine. Specifically, the member may dissolve or otherwise permit urine to pass through the opening after a period of time to test a urine sample which is not from the initial flow of urine to avoid bacteria contamination.

## Claims

### Claim 1

A device for the collection of a urine sample, comprising:
a channel through which urine can flow from a first to a second end thereof;
an opening in the channel at a point between the first and the second ends thereof;
a collector associated with the opening in the channel for receiving urine; and a member covering the opening in the channel which permits urine to pass through the opening only after contact with urine that has flowed through the channel for a period of time; whereby, the collector is able to receive a urine sample which is not from the initial flow of urine.

### Claim 2 (depends on 1)

The device of claim 1 wherein the channel through which urine can flow is defined by a lumen associated with a urinary catheter.

### Claim 3 (depends on 2)

The device of claim 2 wherein the urinary catheter includes a funnel and the lumen defining the channel is located within the funnel.

### Claim 4 (depends on 2)

The device of claim 2 wherein the urinary catheter includes a catheter tube and the lumen defining the channel is located within the tube.

### Claim 5 (depends on 1)

The device of claim 1 wherein the channel through which urine can flow is the lumen of a test device for connection to a urinary catheter.

### Claim 6 (depends on 1)

The device of claim 1 including a urine collection bag associated with the second end of the channel through which urine can flow.

### Claim 7 (depends on 1)

The device of claim 1 wherein the collector associated with the opening in the channel is a urine collection cup surrounding the opening.

### Claim 8 (depends on 1)

The device of claim 1 wherein the collector associated with the opening in the channel leads to a urine test chamber.

### Claim 9 (depends on 1)

The device of claim 1 wherein the member covering the opening in the channel is a soluble membrane formed of PVOH.

### Claim 10 (depends on 1)

The device of claim 1 wherein the member covering the opening in the channel is a non-soluble membrane fixed in place by an adhesive element which reduces in adhesive effectiveness when in contact with liquid.

### Claim 11 (depends on 1)

The device of claim 1 wherein the member covering the opening in the channel is a non-soluble membrane fixed in place by an adhesive element which reduces in adhesive effectiveness when its temperature is raised.

### Claim 12 (depends on 1)

The device of claim 1 wherein the member covering the opening in the channel is a non-soluble membrane which is initially impermeable but increases in permeablity when in contact with liquid.

### Claim 13 (depends on 1)

The device of claim 1 wherein the collector includes at least one test means for receiving and testing urine after the soluble member has dissolved.

### Claim 14

A urinary catheter having a urine sample collector, comprising:
an axially extending body having a lumen defining a channel through which urine can flow from a first to a second end thereof;
a generally radial opening extending through the axially extending body from the lumen to a point externally of the lumen; and
a urine collector for receiving urine surrounding the generally radial opening externally of the axially extending body;
whereby, the urine collector is able to receive a urine sample from urine flowing through the channel defined by the lumen in the axially extending body.

### Claim 15 (depends on 14)

The urinary catheter of claim 14 wherein the axially extending body comprises a funnel and the lumen defining the channel is located within the funnel.

### Claim 16 (depends on 15)

The urinary catheter of claim 15 wherein the funnel includes a first portion of generally uniform diameter secured to a catheter tube and a second portion of outwardly tapering diameter remote from the catheter tube.

### Claim 17 (depends on 16)

The urinary catheter of claim 16 wherein the first portion of generally uniform diameter includes an area of reduced diameter generally intermediate the catheter tube and the second portion of outwardly tapering diameter.

### Claim 18 (depends on 17)

The urinary catheter of claim 17 wherein the generally radial opening extends into the area of reduced diameter, and including a member covering the generally radial opening which permits urine to pass through the opening after the member is in contact with urine for a period of time, the member being located within the area of reduced diameter to cover the generally radial opening.

### Claim 19 (depends on 18)

The urinary catheter of claim 18 wherein the member is selected from one of a soluble membrane which dissolves after being in contact with urine for a period of time, a non-soluble membrane fixed in place by an adhesive element which reduces in adhesive effectiveness when in contact with liquid, a non-soluble membrane fixed in place by an adhesive element which reduces in adhesive effectiveness when its temperature is raised, and a non-soluble membrane which is initially impermeable but increases in permeablity when in contact with liquid.

### Claim 20 (depends on 19)

The urinary catheter of claim 19 including a test chamber surrounding the opening externally of the funnel and containing at least one test means for receiving and testing urine after the member permits urine to pass through the opening.

### Claim 21 (depends on 19)

The urinary catheter of claim 19 including a collection cup removably mounted to a fitting surrounding the opening externally of the funnel for receiving urine after the member permits urine to pass through the opening.

### Claim 22 (depends on 19)

The urinary catheter of claim 19 including a test means located within the area of reduced diameter outwardly of the member for receiving and testing urine after the member permits urine to pass through the opening.

### Claim 23 (depends on 22)

The urinary catheter of claim 22 including a clear waterproof film layer extending about the first portion of generally uniform diameter so as to cover and seal the area of reduced diameter against urine leakage.

### Claim 24 (depends on 14)

The urinary catheter of claim 14 wherein the axially extending body comprises a catheter tube and the lumen defining the channel is located within the tube.

### Claim 25 (depends on 24)

The urinary catheter of claim 24 wherein the generally radial opening extends through the catheter tube and a member is located externally of the catheter tube to initially cover the generally radial opening.

### Claim 26 (depends on 25)

The urinary catheter of claim 25 wherein the member is selected from one of a soluble membrane which dissolves after being in contact with urine for a period of time, a non-soluble membrane fixed in place by an adhesive element which reduces in adhesive effectiveness when in contact with liquid, a non-soluble membrane fixed in place by an adhesive element which reduces in adhesive effectiveness when its temperature is raised, and a non-soluble membrane which is initially impermeable but increases in permeablity when in contact with liquid.

### Claim 27 (depends on 26)

The urinary catheter of claim 26 including a test chamber surrounding the opening externally of the catheter tube and containing at least one test means for receiving and testing urine after the member permits urine to pass through the opening.

### Claim 28 (depends on 26)

The urinary catheter of claim 26 including a collection cup removably mounted to a fitting surrounding the opening externally of the catheter tube for receiving urine after the member permits urine to pass through the opening.

### Claim 29

A device for testing a urine sample, comprising:
an axially extending body having a lumen defining a main channel through which urine can flow from a first end to a second end thereof;
at least one opening extending through the axially extending body from the lumen to a point externally of the lumen; and
a collector for receiving urine surrounding the at least one opening extending through the axially extending body;
whereby, the collector is able to receive a urine sample from urine flowing through the channel defined by the lumen in the axially extending body.

### Claim 30 (depends on 29)

The testing device of claim 29 wherein the axially extending body has a first end for connection to a urinary catheter and a second end remote therefrom.

### Claim 31 (depends on 30)

The testing device of claim 30 wherein the axially extending body includes an external recess intermediate the first and second ends in communication with the at least one opening extending through the axially extending body.

### Claim 32 (depends on 31)

The testing device of claim 31 including a pair of axially spaced openings extending through the axially extending body so as to be in communication with the external recess generally adjacent opposite ends thereof.

### Claim 33 (depends on 32)

The testing device of claim 32 including a channel extending from one of the axially spaced openings to the other of the axially spaced openings to define a secondary urine flow channel therebetween.

### Claim 34 (depends on 33)

The testing device of claim 33 wherein a member which permits urine to pass through after the member is in contact with urine for a period of time is disposed within the external recess of the axially extending body to cover both of the axially spaced openings.

### Claim 35 (depends on 34)

The testing device of claim 34 including at least one test means located within the external recess outwardly of the member for receiving and testing urine has passed through the opening.

### Claim 36 (depends on 35)

The testing device of claim 35 wherein the test means is disposed within the external recess over the secondary urine flow channel for receiving and testing urine after the urine has passed through the opening.

### Claim 37 (depends on 36)

The testing device of claim 36 including a waterproof transparent body extending over the external recess of the axially extending body in a manner covering and sealing the external recess against urine leakage.

### Claim 38 (depends on 29)

The urinary catheter of claim 29 including a member covering the at least one opening which permits urine to pass through after the member is in contact with urine for a period of time and wherein the member is selected from one of a soluble membrane which dissolves after being in contact with urine for a period of time, a non-soluble membrane fixed in place by an adhesive element which reduces in adhesive effectiveness when in contact with liquid, a non-soluble membrane fixed in place by an adhesive element which reduces in adhesive effectiveness when its temperature is raised, and a non-soluble membrane which is initially impermeable but increases in permeablity when in contact with liquid.

### Claim 39 (depends on 29)

The testing device of claim 29 wherein the axially extending body has a first end for connection to a urinary catheter and a second end for connection to a urine collection bag.

### Claim 40

A method for the collection of a urine sample, comprising the steps of:
providing a channel through which urine can flow from a first end to a second end thereof;
forming an opening in the channel at a point between the first and the second end thereof;
covering the opening with a member which permits urine to pass through the opening after contact with urine for a period of time;
locating a collector externally of the channel so as to be in operative association with the opening; and
causing urine to flow through the channel for the period of time until the member permits urine to pass through the opening;
whereby, the collector is capable of receiving a urine sample which is not from the initial flow of urine.

### Claim 41 (depends on 40)

The method of claim 40 wherein the channel through which urine can flow is defined by a lumen associated with a urinary catheter.

### Claim 42 (depends on 41)

The method of claim 41 wherein the urinary catheter includes a funnel and the lumen defining the channel is located within the funnel.

### Claim 43 (depends on 41)

The method of claim 41 wherein the urinary catheter includes a catheter tube and the lumen defining the channel is located within the tube.

### Claim 44 (depends on 40)

The method of claim 40 wherein the channel through which urine can flow is the lumen of a test device for connection to a urinary catheter.

### Claim 45 (depends on 40)

The method of claim 40 wherein the collector associated with the opening in the channel is a urine collection cup surrounding the opening.

### Claim 46 (depends on 40)

The method of claim 40 wherein the collector associated with the opening in the channel leads to a urine test chamber.

### Claim 47 (depends on 40)

The method of claim 40 wherein the member is selected from one of a soluble membrane which dissolves after being in contact with urine for a period of time, a non-soluble membrane fixed in place by an adhesive element which reduces in adhesive effectiveness when in contact with liquid, a non-soluble membrane fixed in place by an adhesive element which reduces in adhesive effectiveness when its temperature is raised, and a non-soluble membrane which is initially impermeable but increases in permeablity when in contact with liquid.

### Claim 48 (depends on 40)

The method of claim 40 wherein the collector includes at least one test means for receiving and testing urine after the soluble member has dissolved.
