# US 12,005,198 B2 · Packaged hydrophilic medical devices

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- Number: US 12,005,198 B2
- Document ID: US12005198B2
- Status: Granted
- Kind: B2
- Application number: 17/612,948
- Filed: 2020-05-21
- Published: 2022-07-21
- Granted: 2024-06-11
- Earliest claimed: 2019-05-22
- Assignees: Hollister Incorporated
- Applicants: Hollister Incorporated
- Inventors: David J Farrell
- Web page: https://patentgrep.com/patent/US12005198B2

## CPC

- A61M 25/002: {Packages specially adapted therefor (combined with means for introducing catheters, e.g. dispensers, A61M25/0113); catheter kit packages (for surgical articles A61B50/30)}
- B65B 5/08: Packaging groups of articles, the articles being individually gripped or guided for transfer to the containers or receptacles
- B65B 31/00: Packaging articles or materials under special atmospheric or gaseous conditions; Adding propellants to aerosol containers
- A61M 25/0017: {specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections}
- A61M 2205/0222: Materials for reducing friction
- A61M 2207/00: Methods of manufacture, assembly or production
- 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)}
- B65B: MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING (bundling and pressing devices for cigars A24C1/44; devices for tensioning and securing binders adapted to be supported by the article or articles to be bound B25B25/00; applying closure members to bottles, jars or similar containers B67B1/00-B67B6/00; concurrent cleaning, filling and closing of bottles B67C7/00; emptying bottles, jars, cans, casks, barrels or similar containers B67C9/00)

## Abstract

Ready to use packaged medical products that include hydrated hydrophilic medical devices and methods of making the same. The packed medical product includes a package defining a cavity with a first compartment and a second compartment separated by a vapor permeable, liquid impermeable barrier. A hydrophilic medical device is contained within the first compartment, and a liquid is contained in the second compartment. The liquid produces a vapor that migrates through the vapor permeable, liquid impermeable barrier into a first compartment. The second compartment has a pressure that is greater than the pressure in the first compartment.

## Claims

### Claim 1

A packaged medical product, comprising:
a package defining a cavity, the cavity including a first compartment and a second compartment wherein the first and second compartments are separated by a vapor permeable, liquid impermeable barrier;
a hydrophilic medical device contained within the first compartment, the hydrophilic medical device including a hydrophilic material that becomes lubricious when hydrated;
a liquid contained in the second compartment, the liquid producing a vapor that migrates through the vapor permeable, liquid impermeable barrier into a first compartment, whereby the vapor hydrates the hydrophilic material; and
wherein the second compartment has a pressure that is greater than a pressure in the first compartment.

### Claim 2 (depends on 1)

The packaged medical product of claim 1, wherein the second compartment includes a pressure increasing mechanism.

### Claim 3 (depends on 2)

The packaged medical product of claim 2, wherein the pressure increasing mechanism comprises components that react with each other to produce a gas.

### Claim 4 (depends on 3)

The packaged medical product of claim 3, wherein the components comprise a first component and a second component, and wherein one of the first and second components comprises an acid and the other of the first component and the second component comprises a carbonate.

### Claim 5 (depends on 4)

The packaged medical product of claim 4, wherein the acid comprises citric acid and the carbonate comprises sodium bicarbonate.

### Claim 6 (depends on 4)

The packaged medical product of claim 4, wherein the first component is in a first solution and the second component is in a second solution, and the first solution and the second solution are mixed to form the liquid.

### Claim 7 (depends on 4)

The packaged medical product of claim 4, wherein the first component is in solid form and the second component is in the liquid.

### Claim 8 (depends on 4)

The packaged medical product of claim 4, wherein the first component and the second component are in solid form.

### Claim 9 (depends on 4)

The packaged medical product of claim 4, wherein the gas comprises one or more of carbon dioxide, nitrogen and oxygen.

### Claim 10 (depends on 1)

The packaged medical product of claim 1, wherein the hydrophilic medical device comprises a urinary catheter.

### Claim 11

A method of making a packaged medical product, comprising:
placing a hydrophilic medical device in a first compartment of a package;
placing a vapor producing liquid in a second compartment of the package, wherein the first compartment and the second compartment are separated by a vapor permeable, liquid impermeable barrier;
closing the package; and
increasing pressure in the second compartment.

### Claim 12 (depends on 11)

The method of claim 11, further including the step of placing a pressure increasing mechanism in the second compartment.

### Claim 13 (depends on 12)

The method of claim 12, wherein the pressure increasing mechanism comprises components that react with each other to produce a gas.

### Claim 14 (depends on 13)

The method of claim 13, wherein the components comprise a first component and a second component, and wherein one of the first and second components comprises an acid and the other of the first component and the second component comprises a carbonate.

### Claim 15 (depends on 14)

The method of claim 14 wherein the acid comprises citric acid and the carbonate comprises sodium bicarbonate.

### Claim 16 (depends on 14)

The method of claim 14, wherein the first component is in a first solution and the second component is in a second solution, and the first solution and the second solution are mixed to form the liquid.

### Claim 17 (depends on 14)

The method of claim 14, wherein the first component is in solid form and the second component is in the liquid.

### Claim 18 (depends on 14)

The method of any claim 14, wherein the first component and second component are in solid form.

### Claim 19 (depends on 13)

The method of claim 13, wherein the gas comprises one or more of carbon dioxide, nitrogen and oxygen.

### Claim 20 (depends on 11)

The method of claim 11, wherein the hydrophilic medical device comprises a urinary catheter.
