Reconstitution system to administer a drug via a high vacuum vial

Patent metadata

Field	Value
Publication number	US-2019381237-A1
Application number	US-201816011076-A
Country	US
Kind code	A1
Filing date	Jun 18, 2018
Priority date	Jun 18, 2018
Publication date	Dec 19, 2019
Grant date	—

Abstract

A reconstitution device includes a first piercing member, a second piercing member, and a receptacle. The first piercing member has a first end and a second end. The first end of the first piercing member is configured to engage an administration port. The first piercing member includes a first fluid pathway extending from the first end of the first piercing member to the second end of the first piercing member. The receptacle includes a collar and a cap. The collar is configured to engage a vial. The cap extends from the collar and holds the second piercing member. A first end of the second piercing member is disposed within the collar.

First claim

The invention is claimed as follows:

1 . A reconstitution device comprising:
a first piercing member having a first end and a second end, the first end of the first piercing member configured to engage an administration port, wherein the first piercing member includes a first fluid pathway extending from the first end of the first piercing member to the second end of the first piercing member; and a receptacle including
a collar configured to engage a vial, and
a cap extending from the collar and holding a second piercing member, wherein a first end of the second piercing member is disposed within the collar.

2 . The reconstitution device of claim 1 , wherein the cap is formed integrally with the collar.

3 . The reconstitution device of claim 1 , wherein the collar is cylindrical and is configured to concentrically engage the vial.

4 . The reconstitution device of claim 1 , wherein the collar engages the vial, such that the first end of the second piercing member extends into the vial, and such that the first piercing member is in fluid communication with the vial via a second fluid pathway extending from the first end of the first piercing member to the first end of the second piercing member.

5 . The reconstitution device of claim 1 , wherein the administration port is an intravenous (“IV”) bag port, and wherein the first end of the first piercing member is configured to pierce the IV bag port to place first piercing member in fluid communication with the IV bag port.

6 . The reconstitution device of claim 1 , further comprising an IV line, wherein the second end of the first piercing member is configured to be connected to the IV line.

7 . The reconstitution device of claim 6 , wherein the first piercing member is fluid communication with the IV line via the first fluid pathway, and wherein the second piercing member is in fluid communication with the IV line via a third fluid pathway extending from the first end of the second piercing member to the second end of the first piercing member.

8 . The reconstitution device of claim 1 , further comprising a membrane, such as a removable membrane or a pierceable membrane.

9 . The reconstitution device of claim 1 , wherein, when placed in an operating position, each of the first piercing member and the second piercing member are oriented vertically.

10 . The reconstitution device of claim 1 , wherein the first end of the first piercing member is formed integrally with the administration port.

11 . The reconstitution device of claim 10 , wherein the administration port is connected to an IV solution container.

12 . The reconstitution device of claim 1 , wherein at least one of the first end of the first piercing member, the second end of the first piercing member, and the first end of the second piercing member includes or defines a syringe needle or a plastic spike.

13 . The reconstitution device of claim 1 , wherein the vial is initially sealed and under a vacuum.

14 . A reconstitution system comprising:
a drug vial; a fluid container; and a reconstitution device, the reconstitution device including
a first piercing member having a first end and a second end, the first end of the first piercing member configured to engage the fluid container and the second end of the first piercing member configured to engage an IV line, wherein the first piercing member includes a first fluid pathway extending from the first end of the first piercing member to the second end of the first piercing member, such that fluid in the fluid container may communicate with the IV line; and
a receptacle including
a collar configured to engage the drug vial, and
a cap extending from the collar and holding a second piercing member, wherein a first end of the second piercing member is disposed within the collar.

15 . The reconstitution system of claim 14 , wherein the collar engages the drug vial, such that the first end of the second piercing member extends into the drug vial, and such that the first piercing member is in fluid communication with the drug vial via a second fluid pathway extending from the first end of the first piercing member to the first end of the second piercing member.

16 . The reconstitution system of claim 15 , wherein the second piercing member is in fluid communication with the IV line via a third fluid pathway extending from the first end of the second piercing member to the second end of the first piercing member.

17 . The reconstitution system of claim 14 , wherein the drug vial contains one of a pharmaceutical agent or a nutritional supplement.

18 . The reconstitution system of claim 14 , wherein the drug vial is initially sealed and under a vacuum.

19 . The reconstitution system of claim 14 , further comprising an infusion pump in operable communication with the IV line.

20 . The reconstitution system of claim 14 , wherein the drug vial is formed of an ultraviolet (“UV”) light blocking material.

21 . A drug reconstitution method comprising:
enabling engagement of a first end of a first piercing member with a fluid container; enabling engagement of a first end of a second piercing member with a drug vial, such that IV fluid may flow along a second fluid pathway extending from the fluid container to the drug vial; enabling mixing of the IV fluid with an agent located within the drug vial to form a mixed drug, such that the mixed drug may flow along a third fluid pathway extending from the drug vial to the IV line; and enabling engagement of a second end of the first piercing member with an IV line, such that IV fluid may flow along a first fluid pathway extending from the fluid container to the IV line.

22 . The drug reconstitution method of claim 20 , which includes enabling the IV fluid and the mixed drug to flow simultaneously from the second end of the first piercing member to the IV line.

23 . A reconstitution device comprising:
a first piercing member having a first end and a second end, wherein the first end of the first piercing member is configured to engage with a fluid container, and wherein the second end of the first piercing member is configured to engage with an IV line, such that IV fluid may flow along a first fluid pathway extending from the fluid container to the IV line; and a second piercing member having a first end, wherein the first end of the second piercing member is configured to engage with a drug vial, such that IV fluid may flow along a second fluid pathway extending from the fluid container to the drug vial, wherein the IV fluid mixes with an agent located within the drug vial to form a mixed drug, such that the mixed drug may flow along a third fluid pathway extending from the drug vial to the IV line, such that the IV fluid and the mixed drug may simultaneously flow from the second end of the first piercing member to the IV line.

Assignees

• Baxter Int
• Baxter Healthcare Sa

Inventors

• Desbrosses Freddy
• Padula Pierpaolo
• Abdessalem Yannis
• Desriaux Marjorie
• Porqueras Diego Santo-Domingo

Classifications

• A61J1/2089

  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) · CPC title

• A61M5/1409 Primary

  in series, e.g. first substance passing through container holding second substance, e.g. reconstitution systems (needle sets A61M5/162) · CPC title

• A61M5/16827

  controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths (infusion of multiple fluids without using a controller A61M5/1407) · CPC title

• A61J1/1406

  Septums, pierceable membranes · CPC title

• A61M39/18

  Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking · CPC title