# US 9,872,970 B2 · Method of preparing a ready-to-use urinary catheter and a catheter assembly for use in said method

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- Number: US 9,872,970 B2
- Document ID: US9872970B2
- Status: Granted
- Kind: B2
- Application number: 14/438,589
- Filed: 2013-10-25
- Published: 2015-10-01
- Granted: 2018-01-23
- Earliest claimed: 2012-10-26
- Assignees: Mbh-International A/S
- Applicants: Mbh-International A/S
- Inventors: Lars Schønfeldt
- Web page: https://patentgrep.com/patent/US9872970B2

## 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)}
- A61M 25/0017: {specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections}
- A61M 27/00: Drainage appliance for wounds or the like {, i.e. wound drains, implanted drains} ({negative pressure wound therapy devices A61M1/90;} implements for holding wound open A61B17/02 {; middle ear drainage A61F11/202})
- B65B 5/045: {in bags}
- B65B 51/00: Devices for, or methods of, sealing or securing package folds or closures; Devices for gathering or twisting wrappers, or necks of bags
- B65B 55/18: by liquids or gases (B65B55/14 takes precedence)
- B65B 55/22: Immersing contents in protective liquids
- 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

A method of preparing a ready-to-use catheter by providing a catheter assembly that has a first compartment that includes a catheter therein. The catheter includes on at least a part of its surface an exterior coating designed to reduce the coefficient of friction after treatment with a liquid swelling medium, and a second compartment containing a liquid swelling medium. The method includes sterilising the catheter assembly, adding the liquid swelling medium to the first compartment for wetting/activating the exterior coating of the catheter, and storing the ready-to-use catheter. By using the method according to the invention, the sterilisation of the catheter is effectuated in a dry-state, ensuring that the known problems with wet-sterilisation are completely eliminated and the need for preparing complicated and expensive liquid swelling mediums are no longer required.

## Claims

### Claim 1

A method of preparing a ready-to-use catheter, said method comprising:
initially providing a catheter assembly (1,1′,1″,1′″), comprising
i. a first compartment (2) comprising a catheter (3), said catheter (3) comprises on at least a part of its surface (6) an exterior coating (7) arranged to reduce the coefficient of friction after treatment with a liquid swelling medium (5), and
ii. a second compartment (4) comprising the liquid swelling medium (5), wherein the method comprises:
sterilising the thus provided catheter assembly (1,1′,1″,1′″),
after sterilizing the catheter assembly, adding the sterilized liquid swelling medium (5) in liquid form from the second compartment (4) to the first compartment (2) for wetting/activating the catheter's exterior coating (7) and rendering it as a ready-to-use catheter,
removing and/or sealing off any gas-permeable parts of the catheter assembly (1,1′,1″,1′″) by making at least the first compartment (2) of a gas-impermeable material, or by placing at least the first compartment (2) in a packaging (13) of a gas-impermeable material;
removing the second compartment (4) from the catheter assembly (1,1′,1″,1′″) after the liquid swelling medium (5) has been added to the first compartment (2), wherein the second compartment (4) is removed without compromising the sterility of the content of the first compartment (2); and
storing the ready-to-use catheter later use.

### Claim 2 (depends on 1)

A method according to claim 1, wherein the second compartment (4) is removed from the catheter assembly (1,1′,1″,1′″) by forming a seal in an intermediate section (17) placed between the first (2) and second compartment (4).

### Claim 3 (depends on 1)

A method according to claim 1, wherein the method further includes providing a hanger/strap (21) and/or an easy-to-grip handle (24) in the catheter assembly (1,1′,1″,1′″).

### Claim 4 (depends on 2)

A method according to claim 2, wherein the hanger/strap and/or an easy-to-grip handle is made in the intermediate section (17) between the first (2) and second compartment (4), or in a separate section placed in proximity to the first compartment (2).

### Claim 5 (depends on 2)

A method according to claim 2, wherein the providing of a hanger/strap (21) and/or an easy-to-grip handle (24) in the catheter assembly (1,1′,1″,1′″) is performed simultaneously with removing the second compartment or subsequent to removal of said second compartment.

### Claim 6 (depends on 1)

A method according to claim 1, wherein the method further includes removing any excess liquid swelling medium (5) and/or air present in the first compartment (2) after the catheters exterior coating (7) has been wetted/activated.

### Claim 7 (depends on 6)

A method according to claim 6, wherein said removing of any excess liquid swelling medium (5) and/or air present in the first compartment (2) after the catheters exterior coating (7) has been wetted/activated is obtained by vacuum suction.

### Claim 8 (depends on 1)

A method according to claim 1, wherein the sterilization of the catheter assembly (1,1′,1″,1′″) is obtained by fumigation with ethylene oxide gas or hydrogen peroxide gas.

### Claim 9 (depends on 1)

A method according to claim 1, wherein the liquid swelling medium (5) is added to the first compartment (2) immediately after sterilization of the catheter assembly (1,1′,1″, 1 ′″).

### Claim 10 (depends on 1)

A method according to claim 1, wherein the liquid swelling medium (5) is added to the first compartment (2) when the catheter assembly (1,1′,1″,1″′) is in the production facilities.

### Claim 11 (depends on 1)

A method according to claim 1, wherein the ready-to-use catheter can be stored for a period of at least 36 months.

### Claim 12 (depends on 1)

A catheter assembly (1,1′,1″, 1 ′″) for use in the method according to claim 1, comprising a first compartment (2) comprising a catheter (3), said catheter (3) comprises on at least a part of its surface (6) an exterior coating (7) arranged to reduce the coefficient of friction after treatment with a liquid swelling medium (5), and a second compartment (4) comprising the liquid swelling medium (5), wherein the second compartment (4) is made of a gas-permeable material, and that the catheter assembly is arranged for adding the swelling medium (5) to the first compartment (2) in liquid form, and wherein said first compartment (2) is made of a gas-impermeable material, or is placed in a packaging (13) of a gas-impermeable material such that any gas-permeable parts of the catheter assembly are either removed and/or sealed off.

### Claim 13 (depends on 12)

A catheter assembly (1,1′,1″,1′″) according to claim 12, wherein the catheter assembly (1,1′,1″,1′″) is partly or completely wrapped by the gas-impermeable material.

### Claim 14 (depends on 13)

A catheter assembly (1,1′,1″,1′″) according to claim 13, wherein said packaging (13) comprises a gas diffusible bacteria barrier (16) that allows for gas-sterilization.

### Claim 15 (depends on 12)

A catheter assembly (1,1′,1″,1′″) according to claim 12, wherein said second compartment (4) comprises an outlet (8) for discharging the liquid swelling medium (5), said outlet (8) is closed by a releasable closure (9) and the outlet is arranged for being in fluid communicating with an opening (10) of the first compartment (2), when the releasable closure (9) is released.

### Claim 16 (depends on 15)

A catheter assembly (1,1′,1″,1′″) according to claim 15, wherein the closure (9) is a rupturable closure.

### Claim 17 (depends on 16)

A catheter assembly (1,1′,1″,1′″) according to claim 16, wherein the rupturable closure is in the form of a membrane (18) or welding, providing a relatively faint joint, which will be ruptured by applying pressure on the second compartment.

### Claim 18 (depends on 16)

A catheter assembly (1,1′,1″,1′″) according to claim 16, wherein the closure (9) is a rupturable membrane, connected with an operating device arranged for rupturing the membrane without opening the catheter package.

### Claim 19 (depends on 12)

A catheter assembly (1,1′,1″,1′″) according to claim 12, wherein the second compartment (4) is a compressible compartment.

### Claim 20 (depends on 12)

A catheter assembly (1,1′,1″,1′″) according to claim 12, wherein the catheter assembly (1,1′,1″,1′″) further comprises a collection bag (22) arranged for collecting fluid during catherisation.

### Claim 21 (depends on 12)

A catheter assembly (1,1′,1″,1′″) according to claim 12, wherein the first compartment (2) comprises a cavity (11) which very narrowly encloses the part of the catheter (3) being provided with the coating (7).

### Claim 22 (depends on 12)

A catheter assembly (1,1′,1″,1′″) according to claim 12, wherein the exterior coating (7) of the catheter (3) is a hydrophilic coating.

### Claim 23 (depends on 12)

A catheter assembly (1,1′,1″,1′″) according to claim 12, wherein the liquid swelling medium (5) does not contain any hydrophilic polymers and/or any buffer components.

### Claim 24 (depends on 12)

A catheter assembly (1,1′,1″,1′″) according to claim 12, wherein the first compartment (2) is placed inside the packaging (13), is combined with said packaging (13) or is formed directly in the packaging (13).

### Claim 25 (depends on 12)

A catheter assembly (1,1′,1″,1′″) according to claim 12, wherein a single second compartment (4) is connected to at least two first compartments.