# US 2019/0167526 A1 · Secured medication transfer system

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- Number: US 2019/0167526 A1
- Document ID: US20190167526A1
- Status: Published application
- Kind: A1
- Application number: 16/323,650
- Filed: 2017-08-18
- Published: 2019-06-06
- Earliest claimed: 2016-08-22
- Assignees: Eli Lilly and Company
- Applicants: Eli Lilly and Company
- Inventors: Keith Daniel Alsberg; Christopher John DeMaria; Kenneth James Micklash, II; Gary Harlan Paulsen
- Web page: https://patentgrep.com/patent/US20190167526A1

## CPC

- A61J 1/2096: {Combination of a vial and a syringe for transferring or mixing their contents}
- A61J 1/16: Holders for containers
- A61M 5/1782: {Devices aiding filling of syringes in situ (combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003)}
- A61J 1/1443: {Containers with means for dispensing liquid medicaments in a filtered or sterile way, e.g. with bacterial filters}
- A61J 1/20: Arrangements for transferring {or mixing} fluids, e.g. from vial to syringe
- A61J 1/201: {having one piercing end}
- A61J 1/2048: {Connecting means}
- A61J 1/2058: {having multiple connecting ports}
- A61J 1/2065: {having aligning and guiding means}
- 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 2039/1077: {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 vial adaptor and needle assembly are disclosed for use with a vial containing a medication, such as insulin. The vial adaptor may include a needle opening configured to receive a needle of a geometrically corresponding needle assembly to withdraw the medication from the vial in a secured manner. The vial adaptor may also include a cleaning passageway configured to receive a cleaning device to clean the vial.

## Claims

### Claim 1

A vial adaptor configured for use with a vial containing a medication and a needle assembly having a needle, the vial adaptor comprising:
a substantially hollow body configured to couple with the vial;
a needle opening in the body, the needle opening being arranged along an axis and being sized and shaped to receive the needle along the axis to withdraw the medication from the vial;
a cleaning passageway in the body, the cleaning passageway being sized and shaped to receive a cleaning device to clean the vial; and
a shroud extending outward from the body to block needle insertion into the vial through the cleaning passageway.

### Claim 2 (depends on 1)

The vial adaptor of claim 1, wherein a lower end of the body includes a generally cylindrical side wall and an upper end of the body includes an upper wall, the shroud extending radially outward beyond the cylindrical side wall of the lower end of the body.

### Claim 3 (depends on 2)

The vial adaptor of claim 2, wherein the shroud extends continuously from the upper wall of the body.

### Claim 4 (depends on 1)

The vial adaptor of claim 1, wherein the shroud extends from the axis of the needle opening by a distance of about 20 millimeters to about 30 millimeters.

### Claim 5 (depends on 1)

The vial adaptor of claim 1, wherein the cleaning passageway is offset from the axis of the needle opening between a first angle greater than 50 degrees and a second angle less than 150 degrees.

### Claim 6 (depends on 5)

The vial adaptor of claim 5, wherein the first angle is about 60 degrees to about 70 degrees and the second angle is about 310 degrees to about 120 degrees.

### Claim 7 (depends on 1)

The vial adaptor of claim 1, wherein an inlet to the cleaning passageway is located in a side wall of the body, the side wall extending radially outward from a lower end of the body to an upper end of the body such that the inlet to the cleaning passageway also extends radially outward from a lower end of the inlet to an upper end of the inlet.

### Claim 8 (depends on 1)

The vial adaptor of claim 1, wherein an inlet to the cleaning passageway includes a notch.

### Claim 9 (depends on 8)

The vial adaptor of claim 8, wherein the notch is positioned closer to a lower end of the inlet than an upper end of the inlet.

### Claim 10 (depends on 1)

The vial adaptor of claim 1, wherein an inlet to the cleaning passageway is larger than an inlet to the needle opening.

### Claim 11 (depends on 1)

The vial adaptor of claim 1, wherein the needle opening follows a linear pathway and the cleaning passageway follows a non-linear pathway.

### Claim 12 (depends on 1)

The vial adaptor of claim 1, wherein the needle opening is formed in a rim, the rim having a tapered outer surface and at least one protrusion for coupling the rim to the body.

### Claim 13 (depends on 1)

The vial adaptor of claim 1, further comprising a needle assembly including a hub having a keyed outer profile that matches the shape of the needle opening.

### Claim 14

A vial adaptor configured for use with a vial containing a medication and having a relatively wide flange, a relatively narrow neck beneath the flange, and a shoulder beneath the neck, the vial adaptor comprising:
a substantially hollow body;
a needle opening in the body, the needle opening being sized and shaped to receive a needle to withdraw the medication from the vial; and
a coupling assembly configured to couple the body to the vial, the coupling assembly including:
a plurality of first fingers, each first finger configured to flex over the flange of the vial and release towards the neck beneath the flange of the vial; and
a plurality of second lingers configured to contact the shoulder of the vial to bias the plurality of first fingers toward the flange of the vial.

### Claim 15 (depends on 14)

The vial adapter of claim 14, wherein each second finger is shorter than each first finger.

### Claim 16 (depends on 14)

The vial adapter of claim 14, wherein the body is sized to cover substantially the entire vial and is at least partially transparent such that the vial is visible through the body.

### Claim 17 (depends on 14)

The vial adapter of claim 14, further comprising:
a passageway in the body, the passageway being sized and shaped to at least one of
receive a cleaning device to clean the vial, and
provide access to a cap of the vial for removal of the cap from the vial; and
a shroud extending outward from the body to block needle access to a stopper of the vial through the passageway.

### Claim 18

A method of using a vial adaptor coupled to a vial, the method comprising:
cleaning a stopper of the vial by inserting a disinfectant-containing cleaning device through a cleaning passageway of the vial adaptor; and
withdrawing a medication from the vial by inserting a needle through a needle opening of the vial adaptor and into the stopper of the vial.

### Claim 19 (depends on 18)

The method of claim 18, further comprising, prior to the cleaning, removing a cap from the vial through the cleaning passageway.

### Claim 20 (depends on 18)

The method of claim 18, further comprising blocking needle insertion into a stopper of the vial through the cleaning passageway with a shroud around the cleaning passageway.
