# US 12,109,388 B2 · Needleless access connectors and valve elements therefor

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- Number: US 12,109,388 B2
- Document ID: US12109388B2
- Status: Granted
- Kind: B2
- Application number: 18/365,180
- Filed: 2023-08-03
- Published: 2024-01-04
- Granted: 2024-10-08
- Earliest claimed: 2009-11-16
- Assignees: CareFusion 303, Inc.
- Applicants: CareFusion 303, Inc.
- Inventors: Tim L. Truitt; Alex Truman Mazza
- Web page: https://patentgrep.com/patent/US12109388B2

## CPC

- A61M 39/24: Check- or non-return valves
- A61M 39/02: Access sites
- A61M 39/10: Tube connectors or tube couplings
- A61M 39/1011: {Locking means for securing connection; Additional tamper safeties (A61M39/16 takes precedence)}
- A61M 39/22: Valves or arrangement of valves {(A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405)}
- A61M 39/26: Valves closing automatically on disconnecting the line and opening on reconnection thereof {(check valves A61M39/24)}
- A61M 2039/242: {designed to open when a predetermined pressure or flow rate has been reached, e.g. check valve actuated by fluid}
- A61M 2039/263: {where the fluid space within the valve is decreasing upon disconnection}
- A61M 2207/00: Methods of manufacture, assembly or production
- Y10T 29/49: Method of mechanical manufacture
- 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)}
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

A collapsible valve for use in a needleless access connector to reduce the priming volume of the needleless access connector. A needleless access connector with a small priming volume. A method of connecting a first medical device to a second medical device with a needleless access connector with a small priming volume.

## Claims

### Claim 1

A needleless access connector comprising:
a housing and a collapsible valve disposed in the housing, the collapsible valve having a first end forming a continuous top surface having a closed circumference, a second end, and an outer side surface between the first and second ends, wherein the collapsible valve comprises a first portion extending from the first end toward the second end, a second portion extending from the first portion toward the second end, and a third portion extending from the second portion to the second end;
the first portion having a substantially cylindrical shape with at least one arcuate cut-out on the outer side surface thereof, the second portion coupled to the first portion and comprising an annular outer surface having a straight cylindrical shape extending from the first portion to the third portion, and the third portion coupled to the second portion and comprising an annular outer surface having a straight cylindrical shape extending from the second portion to the second end;
wherein the collapsible valve comprises a void containing air and extending entirely through the third portion and partially through the second portion when the collapsible valve is coupled to the housing such that the housing and the collapsible valve are configured to provide positive displacement when collapsed.

### Claim 2 (depends on 1)

The needleless access connector of claim 1, wherein the housing comprises channels extending along the second and third portions, the channels adapted to allow fluid to flow between the housing and the collapsible valve when the collapsible valve is collapsed.

### Claim 3 (depends on 1)

The needleless access connector of claim 1, wherein an inner surface of the second portion does not comprise an arcuate cut-out.

### Claim 4 (depends on 1)

The needleless access connector of claim 1, wherein the housing comprises a male fitting at a first end and a female fitting at a second end opposite the first end of the housing.

### Claim 5 (depends on 4)

The needleless access connector of claim 4, wherein the male and female fittings comprise luer fittings.

### Claim 6 (depends on 1)

The needleless access connector of claim 1, wherein:
the housing comprises an opening;
the first portion comprises an end that, when the collapsible valve is in an uncollapsed state, extends into the opening;
the end of the first portion has a first diameter; and
the annular outer surface of the second portion has a second diameter that is larger than the first diameter.

### Claim 7 (depends on 1)

The needleless access connector of claim 1, wherein the at least one arcuate cut-out extends only along the substantially cylindrical shape of the first portion.

### Claim 8

A needleless access connector comprising:
a housing and a collapsible valve disposed in the housing, the collapsible valve having:
a first end, a second end, and an outer side surface between the first and second ends;
a first portion, extending from the first end toward the second end, having a substantially cylindrical shape with at least one arcuate cut-out extending only along the outer side surface;
a second portion coupled to the first portion and extending toward the second end, the second portion comprising an annular outer surface; and
a third portion coupled to the second portion and extending to the second end, the third portion comprising an annular outer surface, wherein each of the annular outer surfaces of the second and third portions comprise straight cylindrical shapes that together extend from the first portion to the second end;
wherein the collapsible valve comprises a void containing air between the housing and the collapsible valve to provide positive displacement when collapsed.

### Claim 9 (depends on 8)

The needleless access connector of claim 8, wherein the housing and the collapsible valve have a priming volume from 0.17 to 0.19 milliliters.

### Claim 10 (depends on 8)

The needleless access connector of claim 8, wherein the housing comprises channels extending along the second and third portions, the channels adapted to allow fluid to flow between the housing and the collapsible valve when the collapsible valve is collapsed.

### Claim 11 (depends on 8)

The needleless access connector of claim 8, wherein the first end comprises a continuous top surface.

### Claim 12 (depends on 8)

The needleless access connector of claim 8, wherein the void extends entirely through the third portion and partially through the second portion.

### Claim 13

A needleless access connector comprising:
a housing comprising an inner surface forming a cavity, a first end forming a first opening into the cavity, and a second end forming a second opening into the cavity;
a collapsible valve positioned in the cavity and having an un-collapsed state and a collapsed state, the collapsible valve comprising a first end, forming a continuous top surface having a closed circumference, a second end, an inner void, and an outer surface defining a first portion extending from the first end of the collapsible valve toward the second end of the collapsible valve, a second portion extending from the first portion toward the second end of the collapsible valve, and a third portion extending from the second portion to the second end of the collapsible valve, wherein the outer surface along the first portion comprises a substantially cylindrical shape with at least one arcuate cut-out, the outer surface along the second and third portions comprise an annular outer surface having a straight cylindrical shape extending from the first portion to the second end, and the collapsible valve is coupled to the housing such that the inner void is formed therebetween to provide positive displacement when the collapsible valve moves between the un-collapsed state and the collapsed state.

### Claim 14 (depends on 13)

The needleless access connector of claim 13, wherein, when the collapsible valve is in the un-collapsed state, the first end of the collapsible valve is positioned within the first opening of the housing.

### Claim 15 (depends on 14)

The needleless access connector of claim 14 wherein, when the collapsible valve moves from the un-collapsed state to the collapsed state, the first portion of the collapsible valve is moved toward the cavity of the housing.

### Claim 16 (depends on 13)

The needleless access connector of claim 13, wherein the housing comprises channels extending along the second and third portions, the channels adapted to allow fluid to flow between the housing and the collapsible valve when the collapsible valve is collapsed.

### Claim 17 (depends on 13)

The needleless access connector of claim 13, wherein the inner void extends entirely through the third portion and partially through the second portion.

### Claim 18 (depends on 13)

The needleless access connector of claim 13, wherein the first end of the housing and the first opening of the housing form a female luer fitting, and the second end of the housing and the second opening of the housing form a male luer fitting.

### Claim 19 (depends on 13)

The needleless access connector of claim 13, wherein the collapsible valve comprises a uniform wall thickness.
