Safty dispensing system for hazardous substances

• US 20060224105A1
• Filed: 06/05/2006
• Published: 10/05/2006
• Est. Priority Date: 05/03/2004
• Status: Active Grant

• Current Assignee: Infusive Technologies, LLC (Element Global, Inc.)
• Original Assignee: Infusive Technologies, LLC (Element Global, Inc.)
• Inventors: Thorne, Gale H., Thorne, Gale H. Jr.
• Granted Patent: US 7,998,106 B2
• Time in Patent Office: Days
• 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. Safety apparatus for transferring hazardous fluids from vial containment to a dispensing syringe, said apparatus comprising:

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

said valve assembly further comprising a structure which is displaceable to at least two stable states whereat in each state the structure provides at least one specific internal pathway, each at least one pathway in each state selectively providing a communicating link for a pair of said ports;

a vial access device securely affixed to a first port, said vial access device comprising a venting filter for selectively permitting only uncontaminated gas to flow between ambient environment and internal parts of said vial access device, but preventing hazardous components of said fluids from external release;

said vial access device further comprising a cannula whereby fluids are accessed from a vial;

a vial connecting structure affixed to said vial access device whereby the vial is securely affixed to said vial access device;

a first syringe connector affixed at a second port of said valve assembly whereat a first pathway of said valve assembly disposed in a first state provides communicating passage for fluid from said vial access device through said first syringe connector;

a first syringe affixed to said first syringe connector;

a second syringe connector affixed at a third port of said valve assembly whereat the first pathway of said valve assembly disposed in a second state provides communicating passage for fluid from said first syringe connector through said second syringe connector;

a second syringe affixed to said syringe connector;

at least one of, said first and second syringes comprising a multi-chamber-pre-flush syringe configuration comprising a syringe with a pre-flush tube affixed thereto, said syringe having a distal chamber and a proximal chamber wherein liquids are kept disparate until delivered from the syringe; and

a clamp for pinching the tube and thereby isolating fluid proximally disposed relative to the clamp from flush fluid distally disposed from the clamp such that hazardous fluid proximally disposed relative to the clamp is kept disparate from a more distally disposed flush liquid.

2. Safety apparatus according to claim 1 wherein said second syringe comprises a multi-chamber configuration.

3. Safety apparatus according to claim 1 wherein said valve assembly further comprises a third syringe connector at a fourth port and a third syringe affixed thereto.

4. Safety apparatus according to claim 3 wherein said third syringe comprises a flush solution.

5. Safety apparatus according to claim 3 wherein said second syringe comprises a multi-chamber configuration wherein a proximal chamber and a distal chamber each initially containing flush liquid.

6. Safety apparatus according to claim 1 wherein said vial connecting structure comprises a seal which provides a seal about said cannula before and an entry site of said vial before said vial site is pierced by said cannula.

7. Safety apparatus according to claim 1 wherein each of said connectors is a luer connector.

8. Safety apparatus according to claim 1 wherein each said luer connector is a luer lock connector.

9. Safety apparatus according to claim 1 wherein said valve assembly comprises visible exterior indicia which communicates to a user the current state of the valve assembly.

10. Safety apparatus according to claim 1 wherein said valve assembly comprises an exterior housing through which said ports are provided.

11. Safety apparatus according to claim 10 wherein said housing comprises a hollow cylindrical through bore hole along the medial axis of the syringe.

12. Safety apparatus according to claim 11 wherein said valve assembly further comprises a cylindrical rod disposed in close fitting relationship within said bore hole.

13. Safety apparatus according to claim 12 wherein said cylindrical rod comprises a plurality of cylindrical seals disposed about said rod whereby the hermetic seal is provided.

14. Safety apparatus according to claim 13 wherein said cylindrical rod comprises the structure comprising grooves and holes which are disposed to provide said pathways.

15. Safety apparatus according to claim 12 wherein said valve assembly comprises at least one handle affixed to said rod whereby said valve assembly is displaced from one state to another.

16. Safety apparatus according to claim 1 wherein said multi-chamber-pre-flush configuration comprises a predetermined length of tubing affixed to said syringe.

17. Safety apparatus according to claim 1 wherein said multi-chamber-pre-flush configuration comprises a pre-filled, multi-chamber syringe comprising proximal and distal chambers, each chamber being filled with flush solution prior to use.

18. A method for transferring a hazardous substance from a vial to a multi-chamber-pre-flush syringe configuration such that no portion of the substance is exposed external to the vial or syringe until delivered from the syringe through a sealed connection to a vessel for use, said method comprising the following steps:

(1) providing the following apparatus;

(a) a hermetically sealed valve assembly comprising a plurality of sealable exterior access ports;

(b) said valve assembly further comprising a structure which is displaceable to at least two stable states whereat in each state the structure provides at least one specific internal pathway, each at least one pathway in each state selectively linking a pair of said ports;

(c) a vial access device securely affixed to a first port, said vial access device comprising a venting filter for selectively permitting only uncontaminated gas to flow between ambient environment and internal parts of said vial access device, but preventing hazardous components of said fluids from external release;

(d) said vial access device further comprising a cannula whereby fluids are accessed from a vial;

(e) a vial connecting structure affixed to said vial access device whereby the vial is securely affixed to said vial access device;

(f) a first syringe connector affixed at a second port whereat a first pathway of said valve assembly disposed in a first state provides communicating passage for fluid from said vial access device through said first syringe connector;

(g) a first syringe affixed to said syringe connector;

(h) a second syringe connector affixed at a third port whereat the first pathway of said valve assembly disposed in a second state provides communicating passage for fluid from said first syringe connector through said second syringe connector;

(i) a second syringe affixed to said syringe connector;

(j) at least one of, said first and second syringes comprising a multi-chamber-pre-flush configuration comprising a multi-chamber syringe with a pre-flusch tube affixed thereto, said syringe having a distal chamber and a proximal chamber wherein fluids are kept disparate until delivered from the syringe; and

(k) the pre-flush tube comprising a distal end and a proximal end which is affixed to said multi-chamber syringe; and

(l) a clamp for occluding said tube;

(2) affixing a vial to said to said valve assembly via said cannula;

(3) displacing said valve assembly to a first stable state whereat a fluid communicating pathway is disposed between said vial and said first syringe;

(4) successively drawing fluids into said multi-chamber-pre-flush syringe assembly until a predetermined measure of contents of the vial are disposed in the distal chamber of the multi-chamber syringe and a predetermined volume of flush liquid is displaced thereafter into the pre-flush tube; and

(5) disposing the tube occluding clamp to maintain hazardous substance liquid proximal to the clamp and disparate from flush solution disposed at the distal end of the tube.

19. A method according to claim 18 wherein step (4) comprises drawing fluid from said vial into a first intermediate syringe from said vial while the valve assembly is in a first state.

20. A method according to claim 19 wherein step (4) further comprises displacing the valve assembly to a second state and drawing fluid from the first intermediate syringe into the multi-chamber-pre-flush configuration.

21. A method according to claim 20 wherein step (4) further comprises displacing the valve assembly to the first state and drawing flush solution into the pre-flush tube whereby the hazardous liquid is captured within the distal chamber of the multi-chamber syringe and flush solution in the distal end of said flush tube.

22. A method according to claim 20 wherein another step comprises removing the distal end flush tube from connection to the associated port and capping that distal end with a cap prior to delivery of the so filled multi-chamber-pre-filled configuration to a site of use.