# US 9,039,989 B2 · Disinfection cap for disinfecting a male luer end of an infusion therapy device

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- Number: US 9,039,989 B2
- Document ID: US9039989B2
- Status: Granted
- Kind: B2
- Application number: 13/766,556
- Filed: 2013-02-13
- Published: 2014-08-14
- Granted: 2015-05-26
- Earliest claimed: 2013-02-13
- Assignees: Becton, Dickinson and Company
- Applicants: Becton, Dickinson and Company
- Inventors: Huibin Liu; Minh Quang Hoang
- Web page: https://patentgrep.com/patent/US9039989B2

## CPC

- A61L 2/16: using chemical substances
- A61M 39/16: having provision for disinfection or sterilisation {(A61M39/143 takes precedence)}
- A61M 39/162: {with antiseptic agent incorporated within the connector}
- A61M 39/20: Closure caps or plugs for connectors or open ends of tubes
- A61M 2039/0036: {characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer}
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- 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)}

## Abstract

The present invention extends to a disinfection cap for disinfecting a male luer end of an infusion therapy device. The disinfection cap can include an internal reservoir containing an antimicrobial or saline solution which is sealed with a flexible septum to prevent the solution from evaporating. The septum can include one or more slits or pierceable seams that allow a male luer end of an infusion therapy device to be inserted through the septum and into the solution. While the male luer is inserted through the septum, the solution contacts both the inner and outer surfaces of the male luer. Because the septum reduces evaporation of the solution and prevents the solution from leaking out of the cap, the solution remains in contact with the male luer for a longer duration then when typical disinfection caps are used thereby increasing the effectiveness of the disinfectant.

## Claims

### Claim 1

A disinfection cap comprising:
an outer support structure forming a first cavity;
an inner support structure integrally formed with the outer support structure and positioned within the first cavity, the inner support structure having an inside diameter that is greater than the outside diameter of a male luer, the inner support structure forming a second cavity that contains a solution for disinfecting the inner and outer surfaces of the male luer when the male luer is inserted into the second cavity; and
a septum attached to an outer top surface of the inner support structure thereby forming a seal for maintaining the solution within the second cavity, the septum being pierceable to allow a male luer to be inserted through the septum into the second cavity.

### Claim 2 (depends on 1)

The cap of claim 1, wherein the outer support structure comprises a cylinder.

### Claim 3 (depends on 1)

The cap of claim 1, wherein the inner support structure comprises a cylinder.

### Claim 4 (depends on 1)

The cap of claim 1, wherein the solution comprises an antimicrobial solution.

### Claim 5 (depends on 1)

The cap of claim 1, wherein the solution comprises a saline solution that mixes with an antimicrobial coating on the male luer.

### Claim 6 (depends on 1)

The cap of claim 1, wherein the septum comprises silicone.

### Claim 7 (depends on 1)

The cap of claim 1, wherein the septum includes one or more slits or seams that split when the male luer is inserted through the septum.

### Claim 8 (depends on 7)

The cap of claim 7, wherein the one or more slits or seams have a radius from a center of the septum that is less than a radius of an outside diameter of the male luer such that the septum remains in contact with the outer surface of the male luer when the male luer is inserted through the septum.

### Claim 9 (depends on 8)

The cap of claim 8, wherein the septum wipes solution from the outer surface of the male luer when the male luer is removed from the septum.

### Claim 10 (depends on 1)

The cap of claim 1, further comprising:
a seal that is attached to the outer support structure to form a seal over the first cavity.

### Claim 11 (depends on 1)

The cap of claim 1, wherein the inner support structure has an outer diameter that increases from the top surface of the inner support structure towards a base of the inner support structure.

### Claim 12 (depends on 1)

The cap of claim 1, wherein the septum includes an extension along an outer edge of the septum, wherein the extensions wraps around a portion of the inner support structure to attach the septum to the inner support structure.

### Claim 13 (depends on 12)

The cap of claim 12, wherein the extension extends substantially to a base of the inner support structure.

### Claim 14

A disinfection cap comprising:
an outer support structure forming a first cavity;
an inner support structure integrally formed with the outer support structure and positioned within the first cavity, the inner support structure having an inside diameter that is greater than the outside diameter of a male luer, the inner support structure forming a second cavity that contains a solution for disinfecting the inner and outer surfaces of the male luer when the male luer is inserted into the second cavity;
a frame that is configured to be secured within the cap; and
a septum attached to the frame such that when the frame is secured within the cap, the septum is secured to or against an outer top surface of the inner support structure thereby forming a seal over the second cavity for maintaining the solution within the second cavity, the septum being pierceable to allow a male luer to be inserted through the septum into the second cavity.

### Claim 15 (depends on 14)

The cap of claim 14, wherein the frame is inserted between the outer and inner support structures.

### Claim 16 (depends on 14)

The cap of claim 14, wherein the frame is inserted inside the second cavity.

### Claim 17 (depends on 14)

The cap of claim 14, wherein the septum comprises silicone.

### Claim 18 (depends on 14)

The cap of claim 14, wherein the septum includes one or more slits or seams that split when the male luer is inserted through the septum.

### Claim 19

A disinfection cap comprising:
an outer support structure forming a first cavity;
an inner support structure integrally formed with the outer support structure and positioned within the first cavity, the inner support structure having an inside diameter that is greater than the outside diameter of a male luer, the inner support structure forming a second cavity that contains a solution for disinfecting the inner and outer surfaces of the male luer when inserted into the second cavity; and
a silicone septum secured to or against an outer top surface of the inner support structure thereby forming a seal for maintaining the solution within the second cavity, the silicone septum including one or more slits that allow a male luer to be inserted through the septum into the second cavity, the slits being configured such that when the male luer is inserted through the septum, the septum is secured around the outer surface of the male luer to inhibit the flow of solution out of the second cavity.

### Claim 20 (depends on 19)

The disinfection cap of claim 19, further comprising:
a frame to which the septum is attached, the frame being configured to be inserted into the cap such that the septum is positioned to be secured to or against the inner support structure.
