# US 5,788,215 A · Medical intravenous administration line connectors having a luer or pressure activated valve

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- Number: US 5,788,215 A
- Document ID: US5788215A
- Status: Granted
- Kind: A
- Application number: 08/581,057
- Filed: 1995-12-29
- Granted: 1998-08-04
- Earliest claimed: 1995-12-29
- Assignees: Rymed Technologies, Inc.
- Inventors: Dana Wm. Ryan
- Web page: https://patentgrep.com/patent/US5788215A

## CPC

- A61J 1/2096: {Combination of a vial and a syringe for transferring or mixing their contents}
- A61M 39/24: Check- or non-return valves
- A61M 39/26: Valves closing automatically on disconnecting the line and opening on reconnection thereof {(check valves A61M39/24)}
- A61J 1/201: {having one piercing end}
- A61J 1/2037: {having valve means}
- A61M 2039/242: {designed to open when a predetermined pressure or flow rate has been reached, e.g. check valve actuated by fluid}
- A61M 2039/2473: {Valve comprising a non-deformable, movable element, e.g. ball-valve, valve with movable stopper or reciprocating element}
- A61M 2039/2486: {Guided stem, e.g. reciprocating stopper}
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- 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

Medical intravenous administration connectors include a first coupling member having a female luer, a valve member having a substantially rigid stem and a substantially resilient body with a sealing surface, and a second coupling member having a fluid coupling extending from one end and an internal valve member support. The coupling members are structured to couple to each other with the valve member being biased to a closed position. When assembled, the valve stem extends into the female luer, and the valve body biases the sealing surface against an annular ring in the first coupling member thereby blocking fluid communication. Preferably, vanes are provided in the second coupling member on which the resilient body of the valve sits, with the vanes acting as a centering mechanism for the valve. The valve may be opened for fluid flow through the assembly by coupling a male luer to the female luer of the assembly, or by pressure actuation. Several valve members are disclosed and several structures for mating the first and second coupling members are disclosed. Y-injection sites and intravenous manifolds utilizing the valve arrangement and coupling members of the invention are also disclosed. All embodiments are easy to prime, limit priming volume, and are arranged without dead-spaces in which blood can be trapped.

## Claims

### Claim 1

A fluid line connection assembly for coupling to and uncoupling from a first fluid pathway which terminates in a first male luer, the fluid line connection assembly comprising:
a) a first coupling member having a first female luer at a first end of said first coupling member, and a first mating structure;
b) a valve member having a stem and a resilient body with a sealing surface, said valve member disposed relative to said first coupling member with said stem extending into said first female luer, said stem having at least one axial bore and at least one radial bore, said at least one axial bore being in fluid communication with said at least one radial bore, said axial bore having an axis and said radial bore having a surface which forms and angle with said axis, said angle being greater than ninety degrees; and
c) a second coupling member having an open generally cylindrical chamber with a valve member support, a first fluid coupling member in fluid communication with said cylindrical chamber, and a second mating structure for mating and coupling with said first mating structure, said second coupling member being coupled to said first coupling member with said valve member support supporting said resilient body of said valve member such that said sealing surface is biased against said first female luer thereby blocking fluid communication between said female luer and said first cylindrical chamber.

### Claim 2 (depends on 1)

A fluid line connection assembly according to claim 1, wherein:
said first female luer and said stem extending into said first female luer are sized such that,
upon coupling the first male luer to said first female luer, the first male luer engages said stem and moves said stem toward said second coupling member, thereby compressing said resilient body, moving said sealing surface away from said female luer, and opening fluid communication between said female luer and said cylindrical chamber, and
upon uncoupling the first male luer from said first female luer, the first male luer disengages said stem and said resilient body expands towards said female luer such that said sealing surface contacts said female luer and blocks fluid communication between said female luer and said cylindrical chamber.

### Claim 3 (depends on 1)

A fluid line connection assembly according to claim 1, wherein:
said first female luer and said stem extending into said first female luer are sized such that upon coupling the first male luer to said first female luer, the first male luer does not move said stem, but
upon introducing fluid under pressure into said first male luer, fluid engages said stem and moves said stem toward said second coupling member, thereby compressing said resilient body, moving said sealing surface away from said female luer, and opening fluid communication between said female luer and said cylindrical chamber, and
upon ceasing application of pressure to the fluid, the fluid disengages said stem and said resilient body expands towards said female luer such that said sealing surface contacts said female luer and blocks fluid communication between said female luer and said cylindrical chamber.

### Claim 4 (depends on 1)

A fluid line connection assembly according to claim 1, wherein:
said valve member stem has a plurality of radial bores in fluid communication with said axial bore, and
when said sealing surface is moved away from said first female luer, fluid communication between said first female luer and said cylindrical chamber is through said axial bore and said plurality of radial bores.

### Claim 5 (depends on 1)

A fluid line connection assembly according to claim 1, wherein:
said stem and said resilient body are separate mating pieces, and
said stem is relatively rigid compared to said resilient body.

### Claim 6 (depends on 5)

A fluid line connection assembly according to claim 5, wherein:
said stem is formed from a rigid or semi-rigid material.

### Claim 7 (depends on 1)

A fluid line connection assembly according to claim 1, wherein:
said resilient body is formed from a silicone.

### Claim 8 (depends on 1)

A fluid line connection assembly according to claim 1, wherein:
said resilient body has a bellows profile.

### Claim 9 (depends on 1)

A fluid line connection assembly according to claim 1, wherein:
said valve member support includes a fluid passage in fluid communication with said first fluid coupling member.

### Claim 10 (depends on 9)

A fluid line connection assembly according to claim 9, wherein:
said valve member support comprises a plurality of radial vanes and said fluid passage comprises a space between said radial vanes.

### Claim 11 (depends on 10)

A fluid line connection assembly according to claim 10, wherein:
said radial vanes have steps and said resilient body is supported by said steps.

### Claim 12 (depends on 5)

A fluid line connection assembly according to claim 5, wherein:
said body has an axial bore into which said stem fits.

### Claim 13 (depends on 4)

A fluid line connection assembly according to claim 4, wherein:
said plurality of radial bores are ramped away from said axial bore.

### Claim 14 (depends on 1)

A fluid line connection assembly according to claim 1, wherein:
said first mating structure includes a cylinder dimensioned to fit inside said cylindrical chamber; and
said second mating structure includes annular engagement means for sealingly engaging a distal end of said cylinder.

### Claim 15 (depends on 14)

A fluid line connection assembly according to claim 14, further comprising:
d) an O-ring between said first and second mating structures.

### Claim 16 (depends on 14)

A fluid line connection assembly according to claim 14, wherein:
said annular engagement means includes a plurality of circular ridges which sealingly engage said distal end of said cylinder.

### Claim 17 (depends on 14)

A fluid line connection assembly according to claim 14, wherein:
said annular engagement means includes a tapered circular groove.

### Claim 18 (depends on 17)

A fluid line connection assembly according to claim 17, wherein:
said distal end of said cylinder has a V-shaped groove.

### Claim 19 (depends on 14)

A fluid line connection assembly according to claim 14, wherein:
said distal end of said cylinder has an annular ridge.

### Claim 20 (depends on 14)

A fluid line connection assembly according to claim 14, wherein:
said annular engagement means includes a circular ridge.

### Claim 21 (depends on 20)

A fluid line connection assembly according to claim 20, wherein:
said distal end of said cylinder has a V-shaped groove which is engaged by said circular ridge.

### Claim 22 (depends on 14)

A fluid line connection assembly according to claim 14, wherein:
one of said cylinder and said cylindrical chamber is provided with a ramped projection and the other of said cylinder and said cylindrical chamber is provided with a recess or hole for receiving said ramped projection.

### Claim 23 (depends on 1)

A fluid line connection assembly according to claim 1, wherein:
one of said first mating structure and said second mating structure includes an annular channel; and
the other of said first mating structure and said second mating structure includes a cylinder dimensioned to fit inside said annular channel.

### Claim 24 (depends on 23)

A fluid line connection assembly according to claim 23, wherein:
said first mating structure and said second mating structure are sonically welded.

### Claim 25 (depends on 1)

A fluid line connection assembly according to claim 1, wherein:
said valve stem is insert molded into said valve body.

### Claim 26 (depends on 1)

A fluid line connection assembly according to claim 1, wherein:
said valve stem and said valve body are molded as an integral piece.

### Claim 27 (depends on 5)

A fluid line connection assembly according to claim 5, wherein:
said sealing surface of said valve member is a frustroconical portion of said resilient body.

### Claim 28 (depends on 1)

A fluid line connection assembly according to claim 1, wherein:
said valve member support includes a plurality of vanes extending substantially the entire length of said cylindrical chamber.

### Claim 29 (depends on 1)

A fluid line connection assembly according to claim 1, wherein:
said first fluid coupling member includes one of a Y-site adapter, an IV manifold and a male luer.

### Claim 30

A fluid line connection assembly for coupling to and uncoupling from a first fluid pathway which terminates in a first male luer, the fluid line connection assembly comprising:
a) a first coupling member having a first female luer at a first end of said first coupling member, and a first mating structure;
b) a valve member having a substantially rigid stem with a bore and a substantially resilient body with a sealing surface, said valve member disposed relative to said first coupling member with said stem extending into said first female luer; and
c) a second coupling member having an open generally cylindrical chamber with a valve member support, a first fluid coupling member in fluid communication with said cylindrical chamber, and a second mating structure for mating and coupling with said first mating structure, said second coupling member being coupled to said first coupling member with said valve member support supporting said resilient body of said valve member such that said sealing surface is biased against said first female luer thereby blocking fluid communication between said female luer and said first cylindrical chamber, wherein
when said rigid stem is pushed toward said second coupling member, said substantially resilient body is axially compressed, and
said substantially resilient body having a substantially solid portion presenting to said valve member support such that a fluid flow path through said fluid line connection assembly is established substantially without dead space.

### Claim 31 (depends on 30)

A fluid line connection assembly according to claim 30, wherein:
said valve member is constructed with substantially no concavities in which where blood could gather, and where it would be difficult to flush the blood out.

### Claim 32 (depends on 30)

A fluid line connection assembly according to claim 30, wherein:
said stem and said resilient body are separate mating pieces, and said substantially resilient body has an axial bore into which said stem extends.

### Claim 33 (depends on 30)

A fluid line connection assembly according to claim 30, wherein:
said valve stem is insert molded into said resilient body.

### Claim 34 (depends on 30)

A fluid line connection assembly according to claim 30, wherein:
said valve stem and said resilient body are integral with said valve stem molded from a substantially rigid or semi-rigid plastic, and said resilient body molded from a substantially flexible, resilient plastic.

### Claim 35 (depends on 30)

A fluid line connection assembly according to claim 30, wherein:
said valve member support includes a plurality of vane means extending substantially the entire length of said cylindrical chamber for centering said seating surface of said valve member against said first female luer.
