Controlled medicament security enclosure system

• US 6,551,298 B1
• Filed: 11/21/2000
• Issued: 04/22/2003
• Est. Priority Date: 11/21/2000
• Status: Expired due to Fees

• Current Assignee: International Medication Systems Limited (Amphastar Pharmaceuticals Incorporated)
• Original Assignee: International Medication Systems Limited (Amphastar Pharmaceuticals Incorporated)
• Inventors: Luo, Mary Ziping, Xia, Frank Zhishi, Zhang, Jack Y.
• Primary Examiner(s): Lazarus, Ira S.
• Assistant Examiner(s): NGUYEN, CAMTU TRAN
• Application Number:
  US09/718,112
• Time in Patent Office: 882 Days
• Field of Search: 604/162, 604/5.01, 604/403, 604/430, 604/259, 604/91, 206/362, 206/363, 206/364, 206/366, 206/15.3, 417/474
• US Class Current: 604/403
• CPC Class Codes: A61J 1/062 Carpules
• CPC Class Codes: A61J 1/16 Holders for containers
• CPC Class Codes: A61M 5/14212 Pumping with an aspiration and an expulsion action

Abstract

A controlled medicament security enclosure system that houses liquid filled reservoirs which consists of a portable enclosure (20) formed with a top half (22) and a bottom half (24) that permanently snap together to form a secure inseparable repository for the reservoirs. Inside the enclosure is at least one glass vial (36) for storing the liquid medicament with each vial having a sliding piston stopper (42) within that seals the inside of the vial and slides to maintain the liquid air free regardless of the volume. An adapter socket (48) is removably attached to the stopper and includes a hollow needle that pierces the stopper and permits a flowpath for the liquid. A flexible outlet tube (62) along with connectors on each end transmit the medicament to a mechanical drug delivery system that has a peristaltic pump and a control module.

Claims

1. A controlled medicament security enclosure system for housing reservoirs comprising:

a) a portable enclosure of a configuration to accept medicament reservoirs, said enclosure having a top half and a bottom half defined such that they permanently snap together to form a secure, inseparable repository for the reservoirs,

b) at least one glass medicament vial, defined as a reservoir, disposed within the enclosure having liquid medicament therein,

c) a sliding piston stopper compressed within the vial contiguously engaging the medicament such that the stopper is free to slide within the vial confines in a hermetically sealed manner when medicament is transferred therefrom, said stopper also having stopper attachment means integrally formed therewith,

d) an adapter socket having a hollow needle therein, socket attachment means integrally formed therewith and a fluid outlet, said socket attached to the stopper socket attachment means and the needle penetrating the stopper such that the needle is in communication with the medicament and the fluid outlet,

e) a first tubing connector attached to said adapter socket fluid outlet for interface therewith,

f) a flexible outlet tube attached to said first tubing connector for transferring medicament from the vial, and

g) a second outlet tubing connector attached to said flexible outlet tube for interfacing with and delivering medicament to a drug delivery device that includes a pumping and control mechanism.

2. A controlled medicament security enclosure system for housing reservoirs comprising:

a) a portable enclosure of a configuration to accept medicament reservoirs, said enclosure having a top half and a bottom half defined such that they permanently snap together to form a secure, inseparable repository for the reservoirs, wherein the enclosure'"'"'s top half and bottom half each having a mating arched opening which jointly creates a round opening for outlet tube egress,

b) at least one glass medicament vial, defined as a reservoir, disposed within the enclosure having liquid medicament therein, wherein said portable enclosure is configured and is of a size on its interior to accommodate said vial,

c) a sliding piston stopper compressed within the vial contiguously engaging the medicament such that the stopper is free to slide within the vial confines in a hermetically sealed manner when medicament is transferred therefrom, said stopper also having stopper attachment means integrally formed therewith,

d) an adapter socket having a hollow needle therein, socket attachment means integrally formed therewith and a fluid outlet, said socket attached to the stopper socket attachment means and the needle penetrating the stopper such that the needle is in communication with the medicament and also the fluid outlet,

e) a first tubing connector attached to said adapter socket fluid outlet for interface therewith,

f) a flexible outlet tube attached to said first tubing connector for transferring medicament from the vial, wherein said flexible outlet tube comprises a resilient hollow intravenous tube, wherein the tube free length is longer than the vial length, and

g) a second outlet tubing connector attached to said flexible outlet tube for interfacing with and delivering medicament to a drug delivery device that includes a pumping and control mechanism.

3. The controlled medicament security enclosure system as recited in claim 2 further comprising a Y fitting that is attached to the outlet tube when two vials of medicament are employed for connecting the outlet tube from each vial to join the tube into a single outlet.

4. The controlled medicament security enclosure system as recited in claim 2 wherein said portable enclosure is disposable after usage, as the enclosure half'"'"'s are permanently secured.

5. The controlled medicament security enclosure system as recited in claim 2 wherein said portable enclosure further having a plurality of notched recesses in the top half, and the bottom half having a plurality of mating tapered jaws, or visa versa, such that the jaws are urged outwardly when the half'"'"'s are pressed together, permitting the jaws to snap into the recesses and forming a non-removable junction.

6. The controlled medicament security enclosure system as recited in claim 2 wherein said hollow needle in said adapter socket is less that 2 inches (5.08 cm) in length.

7. The controlled medicament security enclosure system as recited in claim 2 wherein said portable enclosure is constructed of a thermoplastic material selected from a group consisting of polyethylene, polystyrene, polypropylene, polycarbonate, polyester, polyvinylchloride, polysulfone, polyurethane and cellulose.

8. The controlled medicament security enclosure system as recited in claim 2 wherein said medicament vial is tubular having straight walls, and is closed on a first end and open on a opposed second end.

9. A controlled medicament security enclosure system for housing reservoirs comprising:

a) a portable enclosure of a configuration to accept medicament reservoirs, said enclosure having a top half and a bottom half defined such that they permanently snap together to form a secure, inseparable repository for the reservoirs,

b) at least one glass medicament vial, defined as a reservoir, disposed within the enclosure having liquid medicament therein, wherein said portable enclosure further comprising a partition barrier within the enclosure to separate vials when more than one vial is housed within said enclosure,

c) a sliding piston stopper compressed within the vial contiguously engaging the medicament such that the stopper is free to slide within the vial confines in a hermetically sealed manner when medicament is transferred therefrom, said stopper also having stopper attachment means integrally formed therewith,

d) an adapter socket having a hollow needle therein, socket attachment means integrally formed therewith and a fluid outlet, said socket attached to the stopper socket attachment means and the needle penetrating the stopper such that the needle is in communication with the medicament and also the fluid outlet,

e) a first tubing connector attached to said adapter socket fluid outlet for interface therewith,

f) a flexible outlet tube attached to said first tubing connector for transferring medicament from the vial, wherein said flexible outlet tube comprises a resilient hollow intravenous tube, wherein the tube free length is longer than the vial length, and

g) a second outlet tubing connector attached to said flexible outlet tube for interfacing with and delivering medicament to a drug delivery device that includes a pumping and control mechanism.

10. A controlled medicament security enclosure system for housing reservoirs comprising:

a) a portable enclosure of a configuration to accept medicament reservoirs, said enclosure having a top half and a bottom half defined such that they permanently snap together to form a secure, inseparable repository for the reservoirs,

b) at least one glass medicament vial, defined as a reservoir, disposed within the enclosure having liquid medicament therein,

c) a sliding piston stopper compressed within the vial contiguously engaging the medicament such that the stopper is free to slide within the vial confines in a hermetically sealed manner when medicament is transferred therefrom, said stopper also having stopper attachment means integrally formed therewith, wherein said sliding piston stopper is formed of a resilient material, and the stopper further comprises a plurality of compressible peripheral chevrons for sealing to the vial, said integrally formed stopper attachment means comprise stopper external threads on an end opposite the chevrons,

d) an adapter socket having a hollow needle therein, socket attachment means integrally formed therewith and a fluid outlet, said socket attached to the stopper socket attachment means and the needle penetrating the stopper such that the needle is in communication with the medicament and also the fluid outlet,

e) a first tubing connector attached to said adapter socket fluid outlet for interface therewith,

f) a flexible outlet tube attached to said first tubing connector for transferring medicament from the vial, wherein said flexible outlet tube comprises a resilient hollow intravenous tube, wherein the tube free length is longer than the vial length, and

g) a second outlet tubing connector attached to said flexible outlet tube for interfacing with and delivering medicament to a drug delivery device that includes a pumping and control mechanism.

11. The controlled medicament security enclosure system as recited in claim 10 wherein said integrally-formed, adapter socket attachment means comprise adapter internal threads that interface with said stopper external threads, and said adapter socket further comprises a set of adapter socket outlet internal threads surrounding the fluid outlet, wherein the diameter of the adapter socket is less than the vial internal diameter.

12. The controlled medicament security enclosure system as recited in claim 11 wherein said first tubing connector further having external threads thereon that interface with said adapter socket internal threads for fluid connection therebetween.

13. A controlled medicament security enclosure system for housing reservoirs comprising:

a) a portable enclosure of a configuration to accept medicament reservoirs, said enclosure having a top half and a bottom half defined such that they permanently snap together to form a secure, inseparable repository for the reservoirs,

b) at least one glass medicament vial, defined as a reservoir, disposed within the enclosure having liquid medicament therein,

c) a sliding piston stopper compressed within the vial contiguously engaging the medicament such that the stopper is free to slide within the vial confines in a hermetically sealed manner when medicament is transferred therefrom, said stopper also having stopper attachment means integrally formed therewith,

d) an adapter socket having a hollow needle therein, socket attachment means integrally formed therewith and a fluid outlet, said socket attached to the stopper socket attachment means and the needle penetrating the stopper such that the needle is in communication with the medicament and also the fluid outlet,

e) a first tubing connector attached to said adapter socket fluid outlet for interface therewith,

f) a flexible outlet tube attached to said first tubing connector for transferring medicament from the vial, wherein said flexible outlet tube comprises a resilient hollow intravenous tube, wherein the tube free length is longer than the vial length, and

g) a second outlet tubing connector attached to said flexible outlet tube for interfacing with and delivering medicament to a drug delivery device that includes a pumping and control mechanism.

14. The controlled medicament security enclosure system as recited in claim 13 wherein said second outlet tubing connector is known by its registered trademark as a LUER LOCK.

15. A controlled medicament security enclosure system for housing at least one glass medicament vial, with each vial having a sliding piston stopper, an adapter socket with a hollow needle therein, further, said security enclosure system having a tubing connector attached to the adapter socket, a flexible outlet tube attached to the tubing connector and a outlet tubing connector attached to the tubing, wherein the security enclosure system comprising:

a portable enclosure of a configuration to accept medicament having a top half and a bottom half permanently snapped together to produce a secure inseparable repository for medicament reservoirs wherein said portable enclosure is configured and is of a size on its interior to accommodate said vial, and the enclosure'"'"'s top half and bottom half each having a mating arched opening which jointly creates a round opening for outlet tube egress.

16. The controlled medicament security enclosure system as recited in claim 15 wherein said portable enclosure is disposable after usage as the enclosure half'"'"'s are permanently secured.

17. The controlled medicament security enclosure system as recited in claim 15 wherein said portable enclosure further having a plurality of notched recesses in the top half and the bottom half having a plurality of mating tapered jaws, or visa versa, such that the jaws are urged outward when the half'"'"'s are pressed together, thus permitting the jaws to snap into the recesses and forming a non-removable junction.

18. The controlled medicament security enclosure system as recited in claim 15 wherein said portable enclosure further comprising a partition barrier within the enclosure to separate vials when more than one vial is housed within said enclosure.

19. The controlled medicament security enclosure system as recited in claim 15 wherein said portable enclosure is constructed of a thermoplastic material selected from a group consisting of polyethylene, polystyrene, polypropylene, polycarbonate, polyester, polyvinylchloride, polysulfone, polyurethane and cellulose.

20. A controlled security enclosure for housing medicament reservoirs which includes at least one glass medicament vial, each having a sliding piston stopper, an adapter socket with a hollow needle therein, a tubing connector attached to the adapter socket, a flexible outlet tube attached to the tubing connector and a outlet tubing connector attached to the tubing, the security enclosure comprising:

a portable enclosure of a configuration to accept medicament, having a top half and a bottom half permanently snapped together to form a secure retainer, said enclosure is rectangular in shape and of a size to accommodate said vial, said enclosure further having half holes for the egress of the outlet tube, said enclosure is disposable and constructed with male and female interface connections, said enclosure further includes a partition barrier for use with more than one vial, and wherein said enclosure is thermoplastic.