# US 2018/0021220 A1 · Reconstitution device for iv fluids and method of use

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- Number: US 2018/0021220 A1
- Document ID: US20180021220A1
- Status: Published application
- Kind: A1
- Application number: 15/214,325
- Filed: 2016-07-19
- Published: 2018-01-25
- Earliest claimed: 2016-07-19
- Assignees: CareFusion 303, Inc.
- Applicants: CareFusion 303, Inc.
- Inventors: Dennis Anthony TRIBBLE; Thomas Utech
- Web page: https://patentgrep.com/patent/US20180021220A1

## CPC

- A61J 1/2048: {Connecting means}
- A61J 1/10: Bag-type containers
- A61J 1/1475: {Inlet or outlet ports}
- A61J 1/1493: {Containers with shape retaining means, e.g. to support the structure of the container during emptying or filling}
- A61J 1/20: Arrangements for transferring {or mixing} fluids, e.g. from vial to syringe
- B65C 3/26: Affixing labels to non-rigid containers, e.g. bottles made of polyethylene or boxes to be inflated by internal air pressure prior to labelling
- B65D 21/0209: {stackable or joined together one-upon-the-other in the upright or upside-down position (B65D21/0234, B65D21/0235 take precedence)}
- G16H 20/17: delivered via infusion or injection
- G16H 40/63: for local operation
- A61J 2205/10: Bar codes
- A61J 2205/30: Printed labels
- A61J 2205/60: using magnetic or electronic identifications, e.g. chips, RFID, electronic tags
- 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
- B65C: LABELLING OR TAGGING MACHINES, APPARATUS, OR PROCESSES (nailing or stapling in general B25C, B27F; applying labels for packaging purposes B65B; labels, name-plates G09F ){(series-printing machines B41L; containers for the storage or transport of packages B65D)}
- B65D: CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

A system is provided for storage and reconstitution of IV solutions. The system may include one or more storage and reconstitution devices each configured to store and manipulate IV solution containers containing IV solutions in crystalline form that include hydration chemicals and therapeutic drugs. Crystalline hydration chemicals may include crystalline salts and sugars. The containers may be dimensionally precise enough for mechanical manipulation and configured such that sharp objects such as needles are not needed for fluid delivery to or from the container. Each storage and reconstitution device may store stacked containers and may include components for retrieval of a container from the storage and for reconstitution of the contents therein using a sterile water source within the device. IV doses may be manufactured, under appropriate standards, that can be mechanically reconstituted to produce high-quality doses in real time on the patient care unit or in the pharmacy.

## Claims

### Claim 1

A container comprising:
a housing, comprising:
a stackable, machine-manipulable rigid portion; and
an expandable membrane sealingly attached to the stackable, machine-manipulable rigid portion to form an internal volume within the housing, the internal volume configured to store at least one crystalline hydration chemical and at least one crystalline therapeutic drug;
a first port in the housing, the first port configured to receive sterile water for reconstitution of the at least one crystalline hydration chemical and the at least one crystalline therapeutic drug; and
a second port in the housing, the second port configured to receive an intravenous set connector for delivery of a medical fluid formed from the at least one crystalline hydration chemical, the at least one crystalline therapeutic drug, and the sterile water.

### Claim 2 (depends on 1)

The container of claim 1, further comprising the at least one crystalline hydration chemical and the at least one crystalline therapeutic drug stored within the internal volume.

### Claim 3 (depends on 1)

The container of claim 1, wherein the container comprises a first stackable, machine-manipulable container having the stackable, machine-manipulable rigid portion, and wherein the stackable, machine-manipulable rigid portion includes at least one feature configured to engage with a corresponding feature of a second stackable, machine-manipulable container for stacking of the first stackable, machine-manipulable container and the second stackable, machine-manipulable container.

### Claim 4 (depends on 3)

The container of claim 3, wherein the at least one feature of the stackable, machine-manipulable rigid portion is formed at or near a top surface of the stackable, machine-manipulable rigid portion and wherein the stackable, machine-manipulable rigid portion includes at least one additional feature disposed at or near an opposing bottom surface of the stackable, machine-manipulable rigid portion, the additional feature configured to engage with a corresponding feature of a third stackable, machine-manipulable container for stacking of the first stackable, machine-manipulable container, the second stackable, machine-manipulable container, and the third stackable, machine-manipulable container.

### Claim 5 (depends on 1)

The container of claim 1, wherein the expandable membrane comprises an oversized plastic membrane.

### Claim 6 (depends on 1)

The container of claim 1, wherein the expandable membrane is formed from a stretchable sheet of material.

### Claim 7 (depends on 1)

The container of claim 1, wherein the expandable membrane is configured to expand to accommodate the sterile water.

### Claim 8

A storage and reconstitution device, comprising:
a storage region configured to store a plurality of stacked, machine-manipulable containers, each container including at least one crystalline hydration chemical;
a sterile water reservoir; and
robotic components configured to:
move at least one of the plurality of stacked, machine-manipulable containers from the storage region to a connector fluidly coupled to the sterile water reservoir,
add sterile water from the sterile water reservoir to the at least one of the plurality of stacked, machine-manipulable containers,
agitate the at least one of the plurality of stacked, machine-manipulable containers,
verify reconstitution of the at least one crystalline hydration chemical within the at least one of the plurality of stacked, machine-manipulable containers,
label the at least one of the plurality of stacked, machine-manipulable containers, and
store tracking information for the at least one of the plurality of stacked, machine-manipulable containers.

### Claim 9 (depends on 8)

The storage and reconstitution device of claim 8, wherein each of the plurality of stacked, machine-manipulable containers includes a housing comprising a rigid portion and an expandable sealing membrane attached to the rigid portion to form a storage cavity therebetween for the least one crystalline hydration chemical and, wherein one or more of the plurality of stacked, machine-manipulable containers includes at least one crystalline therapeutic drug in the storage cavity thereof.

### Claim 10 (depends on 9)

The storage and reconstitution device of claim 9, wherein the rigid portion of the housing of each of the plurality of stacked, machine-manipulable containers includes at least one feature engaged with a corresponding feature of an additional one of the plurality of stacked, machine-manipulable containers.

### Claim 11 (depends on 8)

The storage and reconstitution device of claim 8, wherein the robotic components comprise a robotic arm configured to move the at least one of the plurality of stacked, machine-manipulable containers from the storage region to a connector fluidly coupled to the sterile water reservoir.

### Claim 12 (depends on 11)

The storage and reconstitution device of claim 11, further comprising at least one pump configured to pump the sterile water from the sterile water reservoir to the at least one of the plurality of stacked, machine-manipulable containers.

### Claim 13 (depends on 12)

The storage and reconstitution device of claim 12, further comprising an additional robotic arm configured to agitate the at least one of the plurality of stacked, machine-manipulable containers.

### Claim 14 (depends on 13)

The storage and reconstitution device of claim 13, further comprising a labeler configured to generate the label on a rigid portion of the at least one of the plurality of stacked, machine-manipulable containers.

### Claim 15

A system, comprising:
a first storage and reconstitution device at a first location;
a second storage and reconstitution device at a second location, wherein each of the first and second storage and reconstitution devices comprises:
a storage region configured to store a plurality of stacked, machine-manipulable containers, each container including at least one crystalline hydration chemical and at least one crystalline therapeutic drug;
a sterile water reservoir; and
robotic components configured to:
move at least one of the plurality of stacked, machine-manipulable containers from the storage region to a connector fluidly coupled to the sterile water reservoir,
add sterile water from the sterile water reservoir to the at least one of the plurality of stacked, machine-manipulable containers,
agitate the at least one of the plurality of stacked, machine-manipulable containers, and
verify reconstitution of the at least one crystalline hydration chemical and at least one crystalline therapeutic drug within the at least one of the plurality of stacked, machine-manipulable containers; and
a control system communicatively coupled via a network to the first and second storage and reconstitution devices and configured to push dose orders from clinicians to the first or second storage and reconstitution devices based at least in part on known contents of the stacked, machine manipulable containers stored therein.

### Claim 16 (depends on 15)

The system of claim 15, wherein the first location is a nursing station at a healthcare facility.

### Claim 17 (depends on 16)

The system of claim 16, wherein the second location is pharmacy.

### Claim 18 (depends on 17)

The system of claim 17, further comprising a third storage and reconstitution device at a hazardous materials processing location.

### Claim 19 (depends on 16)

The system of claim 16, wherein the second location is a hazardous materials processing location.

### Claim 20 (depends on 15)

The system of claim 15, wherein the robotic components are further configured to:
label the at least one of the plurality of stacked, machine-manipulable containers, and
store tracking information for the at least one of the plurality of stacked, machine-manipulable containers.
