# US 2016/0250102 A1 · Closed fluid transfer system

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- Number: US 2016/0250102 A1
- Document ID: US20160250102A1
- Status: Published application
- Kind: A1
- Application number: 15/150,855
- Filed: 2016-05-10
- Published: 2016-09-01
- Earliest claimed: 2010-05-27
- Assignees: J & J Solutions, Inc.
- Inventors: Jared Michael Garfield; Randall Scott Koplin; Kent Jeffrey Kallsen; Daniel Juhyung Lee; Stephen R. Mitchell; John R. Slump
- Web page: https://patentgrep.com/patent/US20160250102A1

## CPC

- A61J 1/201: {having one piercing end}
- A61J 1/10: Bag-type containers
- A61J 1/20: Arrangements for transferring {or mixing} fluids, e.g. from vial to syringe
- A61J 1/2051: {having tap means, e.g. tap means activated by sliding}
- A61J 1/2055: {having gripping means}
- A61J 1/2065: {having aligning and guiding means}
- A61J 1/2072: {for internal venting}
- A61J 1/2075: {for external venting}
- A61J 1/2096: {Combination of a vial and a syringe for transferring or mixing their contents}
- A61M 5/162: Needle sets, i.e. connections by puncture between reservoir and tube
- A61M 39/1011: {Locking means for securing connection; Additional tamper safeties (A61M39/16 takes precedence)}
- A61J 1/2089: {Containers or vials which are to be joined to each other in order to mix their contents (combinations of vial and syringe for mixing their contents A61J1/2096)}
- A61M 2039/1027: {Quick-acting type connectors}
- A61M 2039/1072: {with a septum present in the connector}
- A61M 2039/1077: {Adapters, e.g. couplings adapting a connector to one or several other connectors}
- 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

A closed fluid transfer system for fluidly interconnecting a syringe to any one of a patient I.V. set, a vial and an I.V. bag, is provided and includes a first adapter defining a lumen and supporting a seal across a first end of its lumen, the first adapter supporting a rear end of a needle within the lumen, wherein the seal is movable relative to the needle such that a tip of the needle penetrates through the seal; and a second adapter defining a lumen and supporting a seal across a first end of its lumen; wherein when the second adapter is coupled to the first adapter, the second adapter seal abuts the first adapter seal and moves the first adapter seal relative to the tip of the needle such that the tip of the needle penetrates through the abutting first adapter seal and second adapter seal.

## Claims

### Claim 1

A syringe adapter for a closed fluid transfer system, the syringe adapter including:
a housing defining an open distal end and an open proximal end;
a base supported in the open proximal end of the housing and including a syringe adapter luer connector;
a collar slidably and rotatably supported in the housing, the collar defining a longitudinal opening therethrough;
a shuttle slidably extending through longitudinal opening of the collar, the shuttle defining a shuttle lumen extending longitudinally therethrough;
a barrel supported on and extending over a distal end of the shuttle, the barrel defining a central opening aligned with the shuttle lumen;
a biasing member interposed between the collar and the shuttle for urging the collar away from the shuttle; and
a seal interposed between the shuttle and the barrel, wherein the seal extends across the shuttle lumen and the central opening of the barrel.

### Claim 2 (depends on 1)

The syringe adapter according to claim 1, further comprising a needle defining a lumen therethrough, the needle having a proximal end supported in the base such that the lumen of the needle is in fluid communication with the luer connector.

### Claim 3 (depends on 2)

The syringe adapter according to claim 2, wherein the needle has a sharpened distal tip disposed within the shuttle lumen when the shuttle is in a distal-most position.

### Claim 4 (depends on 3)

The syringe adapter according to claim 3, wherein the housing defines a pair of opposed longitudinally extending slots opening from the open distal end of the housing, and wherein the housing includes a pair of opposed longitudinally extending ribs projecting from an inner surface thereof.

### Claim 5 (depends on 4)

The syringe adapter according to claim 4, wherein the collar defines a pair of opposed L-shaped tracks formed in an outer surface thereof and configured to receive a respective longitudinally extending rib of the housing therein, and wherein the collar defines a pair of opposed helical tracks opening from a distal surface of the collar, the opposed helical tracks are aligned with a respective slot of the housing when the collar is in a distal-most position.

### Claim 6 (depends on 5)

The syringe adapter according to claim 5, wherein the syringe adapter is movable from a closed state to an open state;
wherein in the closed state the tip of the needle is disposed within the shuttle lumen, the shuttle is disposed at the distal-most position, and the collar is disposed at a distal-most position; and
wherein the syringe adapter is movable from the closed state to the open state by:
inserting a pair of opposed radially extending guide pins of a male stem of a second adapter into the respective slots of the housing of the syringe adapter, whereby a second adapter seal of the second adapter abuts a first adapter seal of a first adapter;
advancing the second adapter male stem into the open distal end of the housing such that the guide pins of the second adapter enter into the respective helical track of the collar to (1) rotate the collar relative to the housing of the syringe adapter and (2) align the ribs of the housing with a through portion of the collar; and
further advancing the second adapter male stem into the open distal end of the housing causing the collar to move proximally which causes the shuttle to move proximally until the tip of the needle penetrates through the abutting seals, whereby the syringe adapter is in the open state and fluidly interconnects a syringe with the second adapter.

### Claim 7 (depends on 1)

The syringe adapter according to claim 1, wherein the syringe adapter includes a lock out system having:
a lock collar including at least one lock arm extending in a radial direction about the lock collar, wherein each lock arm includes a first end integral with the lock collar and a second free end defining a tooth extending radially outward and being dimensioned to contact a longitudinally extending rib of the housing; and
a shuttle including a relatively larger diameter proximal portion and a relatively smaller diameter distal portion;
wherein, when the shuttle is in the distal-most position, each lock arm is in registration with the relatively larger diameter portion of the shuttle thereby inhibiting each lock arm from deflecting radially inward; and
wherein, when the shuttle is moved proximally, the relatively smaller diameter portion of the shuttle is moved into registration with each lock arm thereby permitting each lock arm to deflect radially inward and to permit the lock collar to rotate.

### Claim 8 (depends on 1)

The syringe adapter according to claim 1, wherein the seal is made from polyisoprene.

### Claim 9

A vial adapter for a closed fluid transfer system, the vial adapter including:
a base defining an opening having a plurality of retainers extending around the opening of the base and being configured to snap-fit connect to a neck of a vial, the base defining a lower inner annular rim and an outer annular rim and a cavity therebetween;
a cover supported on the outer annular rim of the base, wherein an expansion chamber is defined within the cover and the base;
an adapter support situated within the cavity of the base, the adapter support including:
a male stem extending in a first direction from the base, the male stem selectively connectable to and insertable into an open distal end of a syringe adapter, the male stem defining a lumen extending therethrough;
a pair of opposed guide pins extending radially outward from the male stem;
a pair of opposed guide surfaces extending radially outward from the male stem at a location proximal of the guide pins and being in registration with the guide pins; and
a seal extending across the lumen of the male stem; and
a spike extending in a second direction from the annular flange, wherein the spike extends into the opening of the base, wherein the spike includes a first lumen being in fluid communication with the lumen of the male stem, and wherein the spike includes a second lumen being in fluid communication with the expansion chamber; and
a bladder extending between the base and the cover.

### Claim 10 (depends on 9)

The vial adapter according to claim 9, wherein the vial adapter is configured to move a syringe adapter from a closed state to an open state, the syringe adapter including:
a housing defining an open distal end and an open proximal end;
a base supported in the open proximal end of the housing and including the syringe adapter luer connector;
a collar slidably and rotatably supported in the housing, the collar defining a longitudinal opening therethrough;
a shuttle slidably extending through longitudinal opening of the collar, the shuttle defining a shuttle lumen extending longitudinally therethrough;
a barrel supported on and extending over a distal end of the shuttle, the barrel defining a central opening aligned with the shuttle lumen; and
a biasing member interposed between the collar and the shuttle for urging the collar away from the shuttle;
the syringe adapter seal being interposed between the shuttle and the barrel, wherein the syringe first adapter seal extends across the shuttle lumen and the central opening of the barrel; and
the tip of the needle being disposed within the shuttle lumen when the shuttle is in a distal-most position.

### Claim 11 (depends on 10)

The vial adapter according to claim 10, wherein the housing of the syringe adapter defines a pair of opposed longitudinally extending slots opening from the open distal end of the housing, the housing of the syringe adapter including a pair of opposed longitudinally extending ribs projecting from an inner surface thereof; and
the collar of the syringe adapter defines a pair of opposed L-shaped tracks formed in an outer surface thereof and configured to receive a respective longitudinally extending rib therein, the collar defines a pair of opposed helical tracks opening from a distal surface of the collar, the opposed helical tracks being aligned with a respective slot of the housing when the collar is in a distal-most position.

### Claim 12 (depends on 11)

The vial adapter according to claim 11, wherein the vial adapter moves the syringe adapter from the closed state to the open state upon:
inserting the guide pins of the male stem of the vial adapter into the respective slots of the housing of the syringe adapter, whereby the seal of the vial adapter abuts the seal of the syringe adapter;
advancing the male stem of the vial adapter into the open distal end of the housing such that the guide pins enter into the respective helical track of the collar to (1) rotate the collar relative to the housing of the syringe adapter and (2) align the ribs of the housing with a through portion of the collar; and
further advancing the male stem of the vial adapter into the open distal end of the housing causing the collar to move proximally which causes the shuttle to move proximally until the tip of the needle penetrates through the abutting seals, whereby the syringe adapter is in the open state and fluidly interconnects the syringe with the vial adapter.

### Claim 13 (depends on 9)

The vial adapter according to claim 9, wherein the spike of the vial adapter penetrates a septum of the vial upon a connection of the base of the vial adapter to a neck of the vial.

### Claim 14 (depends on 13)

The vial adapter according to claim 13, wherein when a syringe is connected to the syringe adapter, and when the syringe adapter is connected to the vial adapter, and when the vial adapter is connected to the vial, the syringe is in closed fluid communication with the vial.

### Claim 15 (depends on 14)

The vial adapter according to claim 14, wherein when the syringe is connected to the syringe adapter, and when the syringe adapter is connected to the vial adapter, the tip of the needle of the syringe adapter penetrates the abutting seals of the syringe adapter and the vial adapter and when the vial adapter is connected to the vial, the syringe is in closed fluid communication with the vial.

### Claim 16 (depends on 15)

The vial adapter according to claim 15, wherein the vial adapter further includes an adapter support situated within the cavity of the base, the adapter support including:
an annular flange for seating on a lower inner annular rim of the base and forming a fluid tight seal therebetween; and
an annular wall extending from the annular flange and defining an upper inner annular rim, wherein the cover is also supported on the upper inner annular rim.

### Claim 17 (depends on 16)

The vial adapter according to claim 16, wherein air from the syringe is injectable into a cavity of the vial adapter defined between the bladder, and the base and the adapter support, through a fluid passage defined by the needle of the syringe adapter, the lumen of the male stem, the first lumen of the spike, the vial and the second lumen of the spike.

### Claim 18 (depends on 9)

The vial adapter according to claim 9, wherein the seal is made from polyisoprene.

### Claim 19 (depends on 18)

The vial adapter according to claim 18, wherein each seal is made from polyisoprene.