Safety dispensing system for hazardous substances

• US 7,998,106 B2
• Filed: 06/05/2006
• Issued: 08/16/2011
• Est. Priority Date: 05/03/2004
• Status: Expired due to Fees

• Current Assignee: Infusive Technologies, LLC (Element Global, Inc.)
• Original Assignee: Infusive Technologies, LLC (Element Global, Inc.)
• Inventors: Thorne, Gale H., Thorne, Gale H. Jr.
• Primary Examiner(s): Stigell; Theodore J
• Assistant Examiner(s): Anderson; Michael J
• Application Number:
  US11/446,779
• Publication Number:
  US 20060224105A1
• Time in Patent Office: 1,898 Days
• Field of Search: 604/32, 604 82- 92, 604/174, 604/177, 604/180, 604/191, 604212-217
• US Class Current: 604/32
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2058 having multiple connecting ports
• CPC Class Codes: A61J 1/2062 with directional valves
• CPC Class Codes: A61J 1/2075 for external venting
• CPC Class Codes: A61J 1/2082 for gas filtration
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 2039/224 of the slide-valve type

Abstract

A combination of a valve assembly and multi-chamber, sequential delivery syringe is disclosed. The combination effectively provides a safety system for transferring hazardous materials from a vial to a site of use. All potentially hazardous materials are flushed from exposed connecting sites prior to disconnections.

Claims

1. A safety valve apparatus and a multi-chamber dispensing syringe assembly combination for transferring a volume of hazardous fluid from a first source containing the hazardous fluid to the multi-chamber dispensing syringe assembly the combination comprising:

the safety valve apparatus comprising a hermetically sealed valve assembly comprising a plurality of sealable exterior access ports;

the multi-chamber dispensing syringe assembly comprising a multi-chamber syringe and a pre-flush tube subassembly affixed to a distal end of the multi-chamber syringe, the multi-chamber syringe including a barrel which is divided into a proximal chamber and a distal chamber such that fluid in the proximal chamber is kept separate from fluid in the distal chamber until fluid in the distal chamber is dispensed from the syringe, the multi-chamber dispensing syringe assembly being sealably, but releasably affixed via the pre-flush tube subassembly to a first port from the plurality of sealable exterior access ports;

the pre-flush tube subassembly comprising an elongated tube having a releasable, sealing connector, disposed at a distal end thereof, by which the multi-chamber dispensing syringe assembly is affixed to the first port;

the proximal chamber of the multi-chamber syringe being filled with liquid to cleanse the sealing connector as fluid is dispensed from the proximal chamber;

the first source comprising the hazardous fluid being securely and sealably affixed to a second port from the plurality of sealable exterior access ports;

a second source, comprising a flush liquid, affixed to a third port from the plurality of sealable exterior access ports;

the hermetically sealed valve assembly further comprising a structure which is displaceable to at least two states where each state provides at least one isolated internal pathway;

in a first state, the hermetically sealed valve assembly comprises a first isolated internal pathway which allows fluid to flow between the first and second ports, whereby the hazardous fluid is drawn from the first source through the elongated tube and into the distal chamber of the multi-chamber syringe;

in a second state, the hermetically sealed valve assembly comprises a second isolated internal pathway which allows fluid to flow between the first and third ports, whereby the flush liquid is drawn from the second source through the first port to substantially fill the elongated tube after the hazardous fluid is drawn from the first source into the distal chamber of the multi-chamber syringe, thereby cleansing the first port of the hazardous fluid; and

the pre-flush tube subassembly further comprising a clamp disposed about the elongated tube for selectively clamping the elongated tube closed after the flush liquid is drawn into the elongated tube to trap the hazardous fluid between the clamp and the proximal chamber and provide a flushed connection at the first port.

2. A safety valve apparatus and a multi-chamber dispensing syringe assembly combination according to claim 1 wherein the hermetically sealed valve assembly comprises visible exterior indicia which communicates the current state of the hermetically sealed valve assembly to a user.

3. An assembly comprising:

a valve;

a hazardous fluid source in fluid communication with the valve, the hazardous fluid source including hazardous medicine;

a flush liquid source in fluid communication with the valve; and

a syringe in fluid communication with the valve, the syringe including a distal chamber and a proximal chamber separated by a valved stopper, the syringe being configured to sequentially dispense the contents of the distal chamber and the proximal chamber;

wherein the valve moves between a first state where the syringe is in fluid communication with the hazardous fluid source and a second state where the syringe is in fluid communication with the flush liquid source.

4. The assembly of claim 3 comprising a venting filter positioned between the hazardous fluid source and the valve, the venting filter being configured to allow air from an ambient environment to pass through the venting filter to the hazardous fluid source and prevent the hazardous fluid from escaping into the ambient environment.

5. The assembly of claim 3 wherein the syringe is a delivery syringe, the assembly comprising a first syringe which is in fluid communication with the valve, and wherein the valve moves between one state where the first syringe is in fluid communication with the hazardous fluid source, the first state where the first syringe includes the hazardous fluid and is in fluid communication with the delivery syringe, and the second state where the delivery syringe is in fluid communication with the flush liquid source.

6. The assembly of claim 3 comprising an occluding device positioned between the syringe and the valve, the occluding device being configured to occlude fluid flow between the syringe and the valve.

7. The assembly of claim 6 wherein the occluding device includes a clamp that occludes a tube between the syringe and the valve.

8. The assembly of claim 3 wherein the proximal chamber of the syringe is pre-filled with a flush liquid before the syringe is in fluid communication with the valve.

9. The assembly of claim 3 wherein the hazardous fluid source includes a vial containing a hazardous drug.

10. An assembly comprising:

a valve;

a hazardous fluid source in fluid communication with the valve, the hazardous fluid source including hazardous medicine;

a flush liquid source in fluid communication with the valve; and

a syringe in fluid communication with the valve, the syringe including a distal chamber and a proximal chamber separated by a stopper, the syringe being configured to sequentially dispense the contents of the distal chamber and the proximal chamber;

wherein the valve moves between a first state where the syringe is in fluid communication with the hazardous fluid source and a second state where the syringe is in fluid communication with the flush liquid source; and

wherein the proximal chamber of the syringe is pre-filled with a flush liquid before the syringe is in fluid communication with the valve.

11. The assembly of claim 10 comprising a venting filter positioned between the hazardous fluid source and the valve, the venting filter being configured to allow air from an ambient environment to pass through the venting filter to the hazardous fluid source and prevent the hazardous fluid from escaping into the ambient environment.

12. The assembly of claim 10 wherein the syringe is a delivery syringe, the assembly comprising a first syringe which is in fluid communication with the valve, and wherein the valve moves between one state where the first syringe is in fluid communication with the hazardous fluid source, the first state where the first syringe includes the hazardous fluid and is in fluid communication with the delivery syringe, and the second state where the delivery syringe is in fluid communication with the flush liquid source.

13. The assembly of claim 10 comprising an occluding device positioned between the syringe and the valve, the occluding device being configured to occlude fluid flow between the syringe and the valve.

14. The assembly of claim 13 wherein the occluding device includes a clamp that occludes a tube between the syringe and the valve.

15. The assembly of claim 10 wherein the proximal chamber of the syringe is pre-filled with saline solution.

16. An assembly comprising:

a valve;

a hazardous fluid source in fluid communication with the valve, the hazardous fluid source including hazardous medicine;

a flush liquid source in fluid communication with the valve;

a first syringe in fluid communication with the valve; and

a multi-chamber syringe in fluid communication with the valve, the multi-chamber syringe including a distal chamber and a proximal chamber, the syringe being configured to sequentially dispense the contents of the distal chamber and the proximal chamber;

wherein the valve controls fluid communication between each one of the hazardous fluid source, the flush liquid source, the first syringe, and the multi-chamber syringe and each one of the remaining ones of the hazardous fluid source, the flush liquid source, the first syringe, and the multi-chamber syringe; and

wherein the valve moves between a first state where the first syringe is in fluid communication with the hazardous fluid source, a second state where the first syringe is in fluid communication with the multi-chamber syringe, and a third state where the multi-chamber syringe is in fluid communication with the flush liquid source.

17. The assembly of claim 16 comprising a venting filter positioned between the hazardous fluid source and the valve, the venting filter being configured to allow air from an ambient environment to pass through the venting filter to the hazardous fluid source and prevent the hazardous fluid from escaping into the ambient environment.

18. The assembly of claim 16 comprising an occluding device positioned between the multi-chamber syringe and the valve, the occluding device being configured to occlude fluid flow between the multi-chamber syringe and the valve.

19. The assembly of claim 18 wherein the occluding device includes a clamp that occludes a tube between the multi-chamber syringe and the valve.

20. The assembly of claim 16 wherein the proximal chamber of the multi-chamber syringe is pre-filled with a flush liquid before the multi-chamber syringe is in fluid communication with the valve.

21. The assembly of claim 16 wherein the hazardous fluid source includes a vial containing a hazardous drug.

22. The assembly of claim 16 wherein the first syringe is a measuring syringe sized to accurately measure small volumes of the hazardous fluid.

23. The assembly of claim 16 wherein the multi-chamber syringe is in fluid communication with the flush liquid source when the valve is in the first state.