Syringe needle isolation device

• US 5,893,842 A
• Filed: 03/20/1997
• Issued: 04/13/1999
• Est. Priority Date: 02/05/1993
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Imbert, Claude
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): NGUYEN, ANH TUAN TUONG
• Application Number:
  US08/822,204
• Time in Patent Office: 754 Days
• Field of Search: 604/110, 604/187, 604/218, 604/232, 604/236, 604/237, 604/238, 604/240, 604/246, 604/249, 604/905, 128/917
• US Class Current: 604/110
• CPC Class Codes: A61M 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 2005/3132 having flow passages for injection agents at the distal end of the barrel to bypass a sealing stopper after its displacement to this end due to internal pressure increase
• CPC Class Codes: A61M 2005/5046 automatically, e.g. plug actuated by the piston head, one-way valve
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/5013 Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe

Abstract

A syringe assembly having needle isolation features includes an elongate barrel having an open proximal end, a chamber for retaining fluid and a tip portion extending from a distal end of the barrel having a passageway therethrough include communication with the chamber. A valve housing extends outwardly from the tip portion of the barrel having a conduit therethrough in communication with the passageway. A needle cannula having a proximal end, a distal end and a lumen therethrough is provided. The proximal end of the needle is connected to the housing so that the lumen is in fluid communication with the conduit. The housing includes internal valve for allowing liquid under pressure in the chamber to flow distally through the conduit and the lumen while preventing unpressurized liquid in the chamber from flowing through the aperture. The internal valve includes a one-way valve structure for preventing liquid flow through the conduit in a proximal direction toward the chamber.

Claims

1. A prefilled syringe assembly comprising:

an elongate barrel having an open proximal end, a distal end, a chamber for retaining a quantity of fluid therebetween and a tip portion extending from said distal end having a passageway therethrough communicating with said chamber;

a stopper slidably positioned in fluid-tight engagement inside said barrel;

an elongate plunger rod for applying a distally-directed pressure on the quantity of fluid retained within said chamber, said plunger rod projecting proximally from said stopper and extending outwardly from said proximal end of said barrel;

a housing extending outwardly from said tip portion of said barrel having a conduit therethrough in fluid communication with said passageway;

a needle cannula having a proximal end, a distal end and a lumen therethrough, said proximal end of said needle connected to said housing so that said lumen is in fluid communication with said conduit;

said housing including an internal valve assembly for allowing liquid under pressure in said chamber to flow distally through said conduit and said lumen while preventing unpressurized liquid in said chamber from flowing through said conduit and through said lumen;

said internal valve assembly including a one-way valve having a proximal end surface disposed in fluid-tight contact with the tip portion of the barrel when the quantity of fluid in said chamber is not subjected to said distally-directed pressure and which is spaced away from the tip portion of the barrel when the fluid retained in the chamber is subjected to said distally directed pressure, said one-way valve thus configured to permit liquid flow through said passageway only in a distal direction away from said chamber and to preclude liquid flow through said passageway in a proximal direction;

wherein a quantity of liquid held in said chamber will be isolated against inadvertent entry of liquid in a proximal direction through said lumen.

2. The syringe assembly of claim 1 wherein said valve assembly includes means for preventing unpressurized liquid from contacting said conduit of said housing.

3. The prefilled syringe assembly of claim 1 wherein said housing includes:

a cap portion having an open proximal end and a distal end connected to said needle cannula, said cap portion being secured to said tip portion; and

said one-way valve comprising a flexible valve within said cap portion, between said tip portion and said distal end of said cap portion, said flexible valve interacting with said cap portion to allow fluid under said distally-directed pressure in said chamber to flow distally through said lumen of said needle cannula, while preventing fluid not subject to said distally-directed pressure in said chamber from flowing through said passageway.

4. The prefilled syringe assembly of claim 3 wherein said flexible valve is made of material selected from the group consisting of:

thermoplastic, thermoplastic elastomers, natural rubber, synthetic rubber and thermosetting plastic.

5. The prefilled syringe assembly of claim 1 wherein said one-way valve comprises a skirt valve oriented so that said skirt valve will partially collapse under said distally-directed pressure applied to the fluid in said chamber to allow fluid to flow only in a distal direction from said chamber through said passageway.

6. The prefilled syringe assembly of claim 5 wherein said tip portion of said barrel includes a distal end surface surrounding said passageway and said skirt valve includes said proximal end surface in fluid-tight contact with said distal end surface of said tip when the fluid retained in the chamber is not subject to said distally-directed pressure.

7. The prefilled syringe assembly of claim 1 wherein said housing includes:

a cap portion having a distal end connected to said needle cannula, said cap portion being integrally formed with said tip portion of said barrel;

said one-way valve comprising a flexible valve disposed within said cap; and

means for holding said one-way valve in said cap.

8. The prefilled syringe assembly of claim 1 wherein said needle cannula is removably connected to said housing.

9. The prefilled syringe assembly of claim 1 further including a needle hub between said needle cannula and said housing, said needle cannula being fixedly attached to said hub to form a unitary assembly and said hub being removably connected to said housing.

10. The prefilled syringe assembly of claim 9 further including a needle shield having a closed distal end, an open proximal end and a side wall therebetween describing a needle receiving cavity, said needle shield being removably attached to said housing for protecting the needle before use.

11. The prefilled syringe assembly of claim 1 wherein said liquid is a therapeutic liquid.

12. The prefilled syringe assembly of claim 1 further including a needle shield having a closed distal end, an open proximal end and a side wall therebetween describing a needle receiving cavity, said needle shield being removably attached to said housing for protecting the needle before use.