Swabbable needle-free injection port valve system with neutral fluid displacement

• US 6,994,315 B2
• Filed: 01/13/2004
• Issued: 02/07/2006
• Est. Priority Date: 01/13/2004
• Status: Active Grant

• Current Assignee: RyMed Technologies Incorporated
• Original Assignee: RyMed Technologies Incorporated
• Inventors: Kaiser, James M., Gordon, David P., Scarfone, Frank A., Ryan, Dana Wm.
• Primary Examiner(s): Look, Edward K.
• Assistant Examiner(s): Fristoe, Jr., John K.
• Application Number:
  US10/756,601
• Publication Number:
  US 20050151105A1
• Time in Patent Office: 756 Days
• Field of Search: 251/149.1, 251/149.3, 251/149.4, 251/149.6, 251/149.8, 604/246, 604/249, 604/256, 604/95.04, 604/95.05, 604/523, 604/528, 604/533, 604/534, 604/535, 604/537, 604/538, 604/539, 604/905, 600/433, 600/434, 600/435, 600/585
• US Class Current: 251/149.6
• CPC Class Codes: A61M 2039/0205 for injecting media
• CPC Class Codes: A61M 2039/262 having a fluid space within the valve remaining the same upon connection and disconnection, i.e. neutral-drawback valve
• CPC Class Codes: A61M 2039/267 having a sealing sleeve around a tubular or solid stem portion of the connector
• CPC Class Codes: A61M 39/10 Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: A61M 39/26 Valves closing automatically on disconnecting the line and opening on reconnection thereof check valves A61M39/24

Abstract

An improved needle-free intravenous injection port assembly is disclosed. Embodiments include a boot valve with a helical surface, a boot valve and septum which mate with mechanical interference, a spike with a rough outer surface coated with a lubricant, a septum having a shoulder and a single continuous swabbable surface, a septum and a boot valve which are pre-punctured with a solid core steel needle, a septum with a frustroconical extension and a combination single piece septum and boot valve. The injection port assembly provides neutral fluid displacement during coupling and uncoupling.

Claims

1. An injection port assembly for coupling to and uncoupling from a first fluid pathway of a first connector and for coupling to a device provided with a second connector so as to provide a fluid connection between the first and second connectors, said injection port assembly comprising:

a first mating structure adapted to mate with the first connector and a second mating structure coupled to said first mating structure and adapted to mate with the second connector,

a resilient barrier located between said first and second mating structures and movable from a first position in which fluid flow between said first mating structure and said second mating structure is blocked to a second position in which fluid flow between said first mating structure and said second mating structure is permitted,

said resilient barrier includes a boot valve and a septum, and

said septum has a lower frustrum and an upper frustrum of different diameter defining a shoulder, said upper frustrum having a continuous convex surface.

2. An injection port assembly according to claim 1, wherein:

said resilient barrier has a generally helical surface pattern.

3. An injection port assembly according to claim 2, wherein:

said boot valve and said septum are pierced with a solid core needle prior to assembly of said injection port.

4. An injection port assembly according to claim 3, wherein:

said needle has a diameter of approximately 0.072 inches.

5. An injection port assembly according to claim 1, further comprising:

a body incorporating said first and second mating structures.

6. An injection port assembly according to claim 2, wherein;

said boot valve and said septum are mated with mechanical interference.

7. An injection port assembly for coupling to and uncoupling from a first fluid pathway of a first connector and for coupling to a device provided with a second connector so as to provide a fluid connection between the first and second connectors, said injection port assembly comprising:

a first mating structure adapted to mate with the first connector and a second mating structure coupled to said first mating structure and adapted to mate with the second connector,

a resilient barrier located between said first and second mating structures and movable from a first position in which fluid flow between said first mating structure and said second mating structure is blocked to a second position in which fluid flow between said first mating structure and said second mating structure is permitted, and

a spike mounted within said resilient barrier, said spike having a roughened surface which is covered with a lubricant.

8. An injection port assembly for coupling to and uncoupling from a first fluid pathway of a first connector and for coupling to a device provided with a second connector so as to provide a fluid connection between the first and second connectors, said injection port assembly comprising:

a first mating structure adapted to mate with the first connector and a second mating structure coupled to said first mating structure and adapted to mate with the second connector,

a resilient barrier located between said first and second mating structures and movable from a first position in which fluid flow between said first mating structure and said second mating structure is blocked to a second position in which fluid flow between said first mating structure and said second mating structure is permitted, wherein said resilient barrier includes a boot valve and a septum having a lower frustrum, and

a centering means for axially centering said boot valve and said septum, said centering means having a first tapered opening dimensioned to accommodate said lower frustrum and a smooth outer periphery.

9. An injection port assembly according to claim 8, wherein:

said boot valve has a frustroconical extension and said centering means has a second tapered opening dimensioned to accommodate said frustroconical extension.

10. An injection port assembly for coupling to and uncoupling from a first fluid pathway of a first connector and for receiving and passing a fluid into the first fluid pathway from a device provided with a second connector, said injection port assembly comprising:

a) a body having a first end provided with a first mating structure adapted to mate with the first connector, and a second end;

b) a hollow spike defining a shaft having a first end coupled to said body and a second end provided with a penetrating tip, said first mating structure and said hollow spike being in fluid communication with each other;

c) a resilient barrier extending over said spike and having a tip portion about said tip of said spike, said resilient barrier being pre-punctured with a solid core steel needle prior to assembly; and

d) a hollow component having a first end and a second end, said first end being coupled to said body, said hollow component extending around at least portions of said spike and said resilient barrier, and said second end being provided with a second mating structure adapted to removably couple to the second connector, wherein

when the second connector is coupled to said second mating structure, said second connector forces said tip portion of said pre-punctured resilient barrier over said spike such that said second connector and said first connector are in fluid communication with each other through said hollow spike and said first mating structure.

11. An injection port assembly according to claim 10, wherein:

said needle has a diameter of approximately 0.072 inches, and said spike has a roughened surface which is covered with a lubricant.

12. An injection port assembly according to claim 10, wherein:

said resilient barrier includes a boot valve and a septum mated with mechanical interference.

13. An injection port assembly according to claim 12, wherein:

said septum has a lower frustrum and an upper frustrum of different diameter defining a shoulder, said upper frustrum having a continuous convex surface.

14. An injection port assembly according to claim 13, further comprising:

e) a centering means for axially centering said boot valve and said septum relative to said spike, said centering means having a first tapered opening dimensioned to accommodate said lower frustrum.

15. An injection port assembly according to claim 14, wherein:

said boot valve has a frustroconical extension and said centering means has a second tapered opening dimensioned to accommodate said frustroconical extension.

16. An injection port assembly for coupling to and uncoupling from a first fluid pathway of a first connector and for receiving and passing a fluid into the first fluid pathway from a device provided with a second connector, said injection port assembly comprising:

a) a body having a first end provided with a first mating structure adapted to mate with the first connector, and a second end provided with a second mating structure adapted to removably couple to the second connector;

b) a hollow spike coupled to and at least partially surrounded by said body, said hollow spike having a penetrating tip, said first mating structure and said hollow spike being in fluid communication with each other;

c) a resilient first barrier extending over said spike and having a tip portion about said tip of said spike; and

d) a resilient second barrier provided over and contacting said tip portion of said first barrier, said first and second barriers being mated with mechanical interference, wherein

when the second connector is coupled to said second mating structure, said second connector forces said second resilient barrier and said tip portion of said first resilient barrier over said spike with neutral fluid displacement and such that said second connector and said first connector are in fluid communication with each other through said hollow spike and said first mating structure.

17. An injection port assembly according to claim 16, wherein:

said resilient second barrier has a lower frustrum and an upper frustrum of different diameter defining a shoulder, said upper frustrum having a continuous convex surface.

18. An injection port assembly according to claim 16, further comprising:

e) a centering means for axially centering said first barrier and said second barrier relative to said spike, wherein said resilient second barrier has a lower frustrum and said centering means has a first tapered opening dimensioned to accommodate said lower frustrum.

19. An injection port assembly according to claim 18, wherein:

said resilient first barrier has a frustroconical extension and said centering means has a second tapered opening dimensioned to accommodate said frustroconical extension.

20. An injection port assembly for coupling to and uncoupling from a first fluid pathway of a first connector and for receiving and passing a fluid into the first fluid pathway from a device provided with a second connector, said injection port assembly comprising:

a) a body having a first end provided with a first mating structure adapted to mate with the first connector, and a second end provided with a second mating structure adapted to removably couple to the second connector;

b) a hollow spike coupled to and at least partially surrounded by said body, said hollow spike having a shaft having a roughened outer surface and coated with a lubricant and a penetrating tip, said first mating structure and said hollow spike being in fluid communication with each other; and

c) a resilient barrier extending over said spike and having a tip portion about said tip of said spike;

when the second connector is coupled to said second mating structure, said second connector forces said tip portion of said resilient barrier over said spike such that said second connector and said first connector are in fluid communication with each other through said hollow spike and said first mating structure.

21. An injection port assembly according to claim 20, wherein:

said lubricant is a fluorosilicone.

22. An injection port assembly for coupling to and uncoupling from a first fluid pathway of a first connector and for receiving and passing a fluid into the first fluid pathway from a device provided with a second connector, said injection port assembly comprising:

a) a body having a first end provided with a first mating structure adapted to mate with the first connector, and a second end provided with a second mating structure adapted to removably couple to the second connector;

b) a hollow spike coupled to and at least partially surrounded by said body, said hollow spike having a penetrating tip, said first mating structure and said hollow spike being in fluid communication with each other;

c) a resilient first barrier extending over said spike and having a tip portion about said tip of said spike; and

d) a resilient second barrier provided over and contacting said tip portion of said first barrier, said second barrier having a lower frustrum and an upper frustrum of different diameter defining a shoulder, said upper frustrum having a single continuous swabbable surface, wherein

when the second connector is coupled to said second mating structure, said second connector forces said second resilient barrier and said tip portion of said first resilient barrier over said spike such that said second connector and said first connector are in fluid communication with each other through said hollow spike and said first mating structure.

23. An injection port assembly for coupling to and uncoupling from a first fluid pathway of a first connector and for receiving and passing a fluid into the first fluid pathway from a device provided with a second connector, said injection port assembly comprising:

a) a body having a first end provided with a first mating structure adapted to mate with the first connector, and a second end;

b) a hollow spike defining a shaft having a first end coupled to said body and a second end provided with a penetrating tip, said first mating structure and said hollow spike being in fluid communication with each other;

c) a resilient barrier extending over said spike, wherein

when the second connector is coupled to said second mating structure, the second connector forces said resilient barrier over said spike with neutral fluid displacement and such that the second connector and the first connector are in fluid communication with each other through said hollow spike and said first mating structure.

24. An injection port assembly for coupling to and uncoupling from a first fluid pathway of a first connector and for receiving and passing a fluid into the first fluid pathway from a device provided with a second connector, said injection port assembly comprising:

a) a body having a first end provided with a first mating structure adapted to mate with the first connector, and a second end;

b) a hollow spike defining a shaft having a first end coupled to said body and a second end provided with a penetrating tip, said first mating structure and said hollow spike being in fluid communication with each other;

c) a resilient first barrier extending over said spike and having a tip portion about said tip of said spike;

d) a resilient second barrier provided over and contacting said tip portion of said first barrier, wherein

there is no dead space between said first barrier and said second barrier and no dead space between the tip portion of the first barrier and the tip of the spike.

25. An injection port assembly according to claim 24, further comprising:

e) a multiple dose drug vial adapter coupled to said first end of said hollow spike.

26. An injection port assembly according to claim 24, further comprising:

e) a y-site adapter coupled to said first end of said hollow spike.

27. An injection port assembly for coupling to and uncoupling from a first fluid pathway of a first connector and for receiving and passing a fluid into the first fluid pathway from a device provided with a second connector, said injection port assembly comprising:

a) a body having a first end provided with a first mating structure adapted to mate with the first connector, and a second end;

b) a hollow spike defining a shaft having a first end coupled to said body and a second end provided with a penetrating tip, said first mating structure and said hollow spike being in fluid communication with each other;

c) a resilient barrier extending over said spike, wherein said penetrating tip is truncated with an open tip; and

a guide wire adapter including

a male luer adapted to be coupled to said first end of said body;

an elongated member having a tapered throughbore, said elongated member being coupled to said male luer; and

a pierceable fluid barrier mounted between said male luer and said elongated member.

28. A method for coupling and uncoupling a device to a fluid pathway, said method comprising:

coupling an injection port assembly having a valve to the fluid pathway,

coupling the device to the injection port assembly such that the valve is opened putting the device is in fluid communication with the fluid pathway with neutral fluid displacement during coupling.

29. The method according to claim 28, further comprising:

uncoupling the device from the injection port assembly such that the device is no longer in fluid communication with the fluid pathway with neutral fluid displacement during uncoupling.

30. An injection port assembly for coupling to and uncoupling from a first fluid pathway of a first connector and for coupling to a device provided with a second connector so as to provide a fluid connection between the first and second connectors, said injection port assembly comprising:

a first mating structure adapted to mate with the first connector and a second mating structure coupled to said first mating structure and adapted to mate with the second connector,

a resilient barrier located between said first and second mating structures and movable from a first position in which fluid flow between said first mating structure and said second mating structure is blocked to a second position in which fluid flow between said first mating structure and said second mating structure is permitted, said resilient barrier being an integrally formed boot valve and septum, said septum having a pierceable portion which is substantially thicker than said boot valve and when said barrier is moved from said first position to said second position all of said septum is moved.