Reconstitution device for IV fluids and method of use

Patent metadata

Field	Value
Publication number	US-11096867-B2
Application number	US-202016807091-A
Country	US
Kind code	B2
Filing date	Mar 2, 2020
Priority date	Jul 19, 2016
Publication date	Aug 24, 2021
Grant date	Aug 24, 2021

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.

First claim

What is claimed is:

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

2. The storage and reconstitution device of claim 1 , wherein each container of the stack of 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 container of the stack of machine-manipulable containers includes at least one crystalline therapeutic drug in the storage cavity thereof.

3. The storage and reconstitution device of claim 2 , wherein the rigid portion of the housing of each container of the stack of machine-manipulable containers includes at least one feature engaged with a corresponding feature of an additional one container of the stack of machine-manipulable containers.

4. The storage and reconstitution device of claim 1 , wherein the robotic components comprise a robotic arm configured to move the at least one container of the stack of machine-manipulable containers from the storage region to a connector fluidly coupled to the sterile fluid reservoir.

5. The storage and reconstitution device of claim 4 , further comprising at least one pump configured to pump the sterile fluid from the sterile fluid reservoir to the at least one container of the stack of machine-manipulable containers.

6. The storage and reconstitution device of claim 5 , wherein the robotic components further comprise an additional robotic arm configured to agitate the at least one container of the stack of machine-manipulable containers.

7. The storage and reconstitution device of claim 6 , further comprising a labeler configured to generate the label on a rigid portion of the at least one container of the stack of machine-manipulable containers.

8. The storage and reconstitution device of claim 1 , further comprising an optical component configured to verify reconstitution of the at least one crystalline hydration chemical within the at least one container of the stack of machine-manipulable containers.

9. The storage and reconstitution device of claim 8 , wherein the optical component comprises a camera.

10. The storage and reconstitution device of claim 8 , wherein the optical component comprises a laser verification device.

11. 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 stack of machine-manipulable containers, each container including at least one crystalline hydration chemical and at least one crystalline therapeutic drug;
a sterile fluid reservoir; and
robotic components configured to:
move at least one container of the stack of machine-manipulable containers from the storage region to a connector fluidly coupled to the sterile fluid reservoir,
add sterile fluid from the sterile fluid reservoir to the at least one container of the stack of machine-manipulable containers,
agitate the at least one container of the stack of 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 container of the stack of 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 stack of machine-manipulable containers stored therein.

12. The system of claim 11 , wherein the first location is a nursing station at a healthcare facility.

13. The system of claim 12 , wherein the second location is pharmacy.

14. The system of claim 13 , further comprising a third storage and reconstitution device at a hazardous materials processing location.

15. The system of claim 12 , wherein the second location is a hazardous materials processing location.

16. The system of claim 11 , wherein the robotic components are further configured to:
label the at least one container of the stack of machine-manipulable containers, and
store tracking information for the at least one container of the stack of machine-manipulable containers.

17. The system of claim 11 , wherein each container of the stack of 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 container of the stack of machine-manipulable containers includes at least one crystalline therapeutic drug in the storage cavity thereof.

18. The system of claim 17 , wherein the rigid portion of the housing of each container of the stack of machine-manipulable containers includes at least one feature engaged with a corresponding feature of an additional one container of the stack of machine-manipulable containers.

19. The system of claim 11 , wherein the robotic components comprise a robotic arm configured to move the at least one container of the stack of machine-manipulable containers from the storage region to a connector fluidly coupled to the sterile fluid reservoir.

20. The system of claim 19 , further comprising at least one pump configured to pump the sterile fluid from the sterile fluid reservoir to the at least one container of the stack of machine-manipulable containers.

Assignees

• Carefusion 303 Inc

Inventors

• TRIBBLE Dennis Anthony
• Utech Thomas

Classifications

• A61J1/1493 Primary

  Containers with shape retaining means, e.g. to support the structure of the container during emptying or filling · CPC title

• B65D21/0209

  stackable or joined together one-upon-the-other in the upright or upside-down position (B65D21/0234, B65D21/0235 take precedence) · CPC title

• A61J2205/10

  Bar codes · CPC title

• A61J1/20 Primary

  Arrangements for transferring {or mixing} fluids, e.g. from vial to syringe · CPC title

• A61J2205/30

  Printed labels · CPC title