# US 12,491,353 B2 · Syringe with disinfecting feature

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- Number: US 12,491,353 B2
- Document ID: US12491353B2
- Status: Granted
- Kind: B2
- Application number: 17/619,095
- Filed: 2020-02-19
- Published: 2022-07-28
- Granted: 2025-12-09
- Earliest claimed: 2019-02-21
- Assignees: Becton, Dickinson and Company
- Applicants: Becton, Dickinson and Company
- Inventors: Evan Leibowitz
- Web page: https://patentgrep.com/patent/US12491353B2

## CPC

- A61M 39/0247: {Transcutaneous or percutaneous access sites to the inside of the body}
- A61M 39/162: {with antiseptic agent incorporated within the connector}
- A61M 3/0262: {manually, e.g. by squeezing a bulb}
- A61M 2005/3118: {via the distal end of a syringe, i.e. syringe end for mounting a needle cannula}
- A61M 2039/0018: {designed for flushing a line, e.g. by a by-pass}
- A61M 2039/0258: {for vascular access, e.g. blood stream access}
- A61M 2039/0285: {with sterilisation means, e.g. antibacterial coatings, disinfecting pads, UV radiation LEDs or heating means in the port}
- 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

Syringe assemblies comprising an absorbent pad containing disinfectant and a rotatable cap to ensure adherence to aseptic techniques for use in flush procedures for vascular access devices (VAD's) are described. Also described are methods of disinfecting vascular access devices.

## Claims

### Claim 1

A flush syringe assembly comprising:
a barrel including a side wall having an outside surface, an inside surface defining a chamber for retaining fluid, an open proximal end, and a distal end including a distal wall with a distal tip extending distally therefrom having a first passageway therethrough in fluid communication with said chamber;
an outer sleeve slidably engaged with the outside surface of the barrel, the outer sleeve comprising an inner surface, an outer surface, and an open distal end comprising a peripheral distal surface;
a removable seal disposed on the peripheral distal surface; and
a cap rotatably disposed between the distal tip and the open distal end of the outer sleeve and an absorbent pad containing disinfectant disposed between the removable seal and the distal tip, the cap rotatable from a first position in which the distal tip is covered by the cap and a second position in which the distal tip of the barrel is exposed through the open distal end of the outer sleeve; and
a fixed seal located between the cap and the removable seal, wherein rotation of the cap causes the cap to pierce the fixed seal and move through the absorbent pad into the second position.

### Claim 2 (depends on 1)

The flush syringe assembly of claim 1, wherein relative sliding movement of the outer sleeve and the barrel to move the distal tip of the barrel and the open distal end of the outer sleeve closer together causes the distal tip to rotate the cap from the first position to the second position.

### Claim 3 (depends on 2)

The flush syringe assembly of claim 2, the barrel further comprising a connection collar surrounding the distal tip and an alignment collar coaxial with the connection collar, the alignment collar comprising a peripheral tab that engages the outer sleeve.

### Claim 4 (depends on 3)

The flush syringe assembly of claim 3, wherein the connection collar comprises a Luer connector.

### Claim 5 (depends on 3)

The flush syringe assembly of claim 3, wherein the outer sleeve comprises a slot that cooperates with the peripheral tab to align the cap with the open distal end of the outer sleeve and to guide relative sliding movement between the barrel and the outer sleeve.

### Claim 6 (depends on 5)

The flush syringe assembly of claim 5, wherein the slot in the outer sleeve comprises a detent to prevent unintended relative movement of the syringe barrel and the outer sleeve.

### Claim 7 (depends on 5)

The flush syringe assembly of claim 5, wherein the absorbent pad is contained within the cap.

### Claim 8 (depends on 2)

The flush syringe assembly of claim 2, wherein the absorbent pad has a thickness and a cut pattern through the thickness.

### Claim 9 (depends on 8)

The flush syringe assembly of claim 8, wherein rotation of the cap causes the cap to pierce the fixed seal and move through the absorbent pad into the second position.

### Claim 10 (depends on 1)

The flush syringe assembly of claim 1, wherein the absorbent pad is contained within the cap.

### Claim 11 (depends on 10)

The flush syringe assembly of claim 10, wherein peeling away the removable seal exposes the absorbent pad.

### Claim 12 (depends on 11)

The flush syringe assembly of claim 11, wherein when the cap is in the first position, the absorbent pad is exposed through the open distal end of the outer sleeve, and when the cap is in the second position, the cap is rotated through the open distal end of the outer sleeve to expose the distal tip of the barrel.

### Claim 13 (depends on 1)

The flush syringe assembly of claim 1, wherein the removable seal comprises an aluminum or multi-layer polymer film peel back top.

### Claim 14 (depends on 1)

The flush syringe assembly of claim 1, wherein the outer sleeve comprises a flange at a proximal end and the barrel comprises a barrel flange at the proximal end.

### Claim 15

A flush syringe assembly comprising: a barrel including a side wall having an outside surface, an inside surface defining a chamber for retaining fluid, an open proximal end, and a distal end including a distal wall with a distal tip extending distally therefrom having a first passageway therethrough in fluid communication with said chamber; an outer sleeve slidably engaged with the barrel, the outer sleeve comprising an inner surface, an outer surface, and an open distal end comprising a peripheral distal surface; a cap covering the distal tip, the cap comprising a proximal side that covers the distal dip and a distal side including an absorbent pad mounted thereon, the cap pivotally movable from a first position in which the cap covers the distal tip to a second position in which the cap is moved away from the distal tip, allowing the distal tip to be connected to a vascular access device and the cap remains connected to the outer sleeve after moving to the second position; a removable seal disposed on the peripheral distal surface; and a fixed seal located between the cap and the removable seal, wherein rotation of the cap causes the cap to pierce the fixed seal and move through the absorbent pad into the second position.

### Claim 16 (depends on 15)

The flush syringe assembly of claim 15, wherein peeling away the removable seal exposes the absorbent pad.

### Claim 17 (depends on 15)

The flush syringe assembly of claim 15, wherein relative sliding movement of the outer sleeve and the barrel moves the distal tip of the barrel and the open distal end of the outer sleeve closer together, which pushes the distal tip, causing the distal tip to rotate the cap from the first position to the second position.

### Claim 18

A method of disinfecting a vascular access device, the method comprising:
exposing an absorbent pad containing disinfectant at a distal end of a flush syringe assembly comprising a barrel having a distal tip covered by a cap;
contacting the vascular access device with absorbent pad; and
rotating the cap to expose the distal tip of the barrel, wherein the flush syringe assembly further comprises an outer sleeve having and open distal end and a distal surface slidably engaged with the syringe barrel and the method further comprises sliding the syringe barrel and the outer sleeve with respect to each other, causing the cap to rotate away from the distal tip, characterized in that the flush syringe further comprises a fixed seal located between the cap and the removable seal, wherein rotation of the cap causes the cap to pierce the fixed seal and move through the absorbent pad into the second position.

### Claim 19 (depends on 18)

The method of claim 18, further comprising removing a removable seal from the distal surface of the outer sleeve to expose the absorbent pad.