Safety syringe for mixing two-component medicaments

• US 5,360,410 A
• Filed: 08/06/1991
• Issued: 11/01/1994
• Est. Priority Date: 01/16/1991
• Status: Expired due to Fees

• Current Assignee: Senetek Plc
• Original Assignee: Senetek Plc
• Inventors: Wacks, Jonathan L.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): STRIGHT, RONALD K
• Application Number:
  US07/740,843
• Time in Patent Office: 1,183 Days
• Field of Search: 604/82, 604/87-91, 604/187, 604/110, 604/191, 604/195, 604/196, 604/198, 604/200, 604/201, 604/205, 604/206, 604/218, 604/232, 604/234, 604/236, 604/237, 604/403 , 604/411-416, 222/386, 222/390, 222/391
• US Class Current: 604/232
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 2005/2407 from the rear
• CPC Class Codes: A61M 2005/2418 comprising means for damping shocks on ampoule
• CPC Class Codes: A61M 2005/247 with fixed or steady piercing means, e.g. piercing under movement of ampoule
• CPC Class Codes: A61M 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 2005/3131 specially adapted for improving sealing or sliding
• CPC Class Codes: A61M 2005/3231 Proximal end of needle captured or embedded inside piston head, e.g. by friction or hooks
• CPC Class Codes: A61M 2205/195 by the needle tip shape
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/60 with identification means
• CPC Class Codes: A61M 25/0693 Flashback chambers
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/2448 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/2459 upon internal pressure increase, e.g. pierced or burst A61M5/2429 takes precedence
• CPC Class Codes: A61M 5/2466 by piercing without internal pressure increase A61M5/2429 takes precedence
• CPC Class Codes: A61M 5/32 Needles; Details of needles pertaining to their connection with syringe or hub infusion needles A61M5/158; Accessories for bringing the needle into, or holding the needle on, the body A61M5/42, A61M5/46 take precedence; guide needles for catheters A61M25/065; Devices for protection of needles apparatus specially adapted for cleaning or sterilising needles A61M5/001
• CPC Class Codes: A61M 5/322 Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston devices for protecting guide needles in combination with catheters A61M25/0612
• CPC Class Codes: A61M 5/3291 Shafts with additional lateral openings
• CPC Class Codes: A61M 5/348 snap lock, i.e. upon axial displacement of needle assembly A61M5/344 takes precedence

Abstract

A disposable two-component safety syringe with retractable injection needle adapted for the separate storage of medicament and medicament solvent and the pre-injection mixing thereof. The cartridge-type syringe is adapted to be used manually or in conjunction with an automatic injection/aspiration device for breaching a temporary seal between chambers for the medicament and medicament solvent immediately prior to injection are also provided. Pre-measured medicament is provided in a form which requires no pre-injection agitation. The cartridge is also provided with an injection needle disposed completely within the cartridge housing for safely and sanitarily withdrawing the injection needle to reside completely within the disposable cartridge after use. In one embodiment of the invention, a pushrod for automatically agitating the mixing components is provided.

Claims

1. A mixing syringe for two-component medicaments comprising:

(A) a cartridge housing having a first end and a second end, said cartridge housing having a substantially cylindrical cartridge housing bore;

(B) a slidable cartridge disposed in said cartridge housing bore and having a first end, a second end, and a temporary sealing barrier disposed between said first and second ends and separating a cartridge bore of said cartridge into a cylindrical medicament solvent charge chamber and a cylindrical medicament charge chamber,

said cartridge housing having means connected thereto, for breaching said temporary sealing barrier,

said cartridge being suitable for separately storing a medicament solvent charge and a medicament charge in said medicament solvent charge chamber and said medicament charge chamber, respectively, said charges to be mixed to form a medicament to be expelled from said cartridge;

(C) a piston disposed within said first end of said cartridge and being slidably seated in said cartridge bore;

(D) a retractable needle housing assembly slidable in said cartridge housing;

(E) a retractable injection needle fixedly attached to said needle housing assembly and extending therethrough for injecting mixed medicament; and

(F) a puncturable cartridge end stopper rigidly attached to and sealing said second end of said cartridge;

said means for breaching the temporary sealing barrier between chambers of said slidable cartridge comprising a pushrod having an anchoring end and a puncturing end wherein said anchoring end is connected to said cartridge housing, said pushrod extending from said cartridge housing toward said cartridge puncturable end stopper;

said needle assembly housing having a pushrod aperture for freely guiding said pushrod therethrough so that said puncturing end of said pushrod resides in close proximity to and in alignment with said puncturable cartridge end stopper.

2. The device of claim 1 wherein said breachable temporary sealing barrier comprises a membrane.

3. The device of claim 2 wherein said membrane comprises a synthetic polymer.

4. The device of claim 3 wherein said polymer is polystyrene.

5. The device of claim 2 wherein said membrane comprises rubber.

6. The device of claim 3 wherein said polymer is polyethylene.

7. The device of claim 1 wherein said needle housing assembly is slidably disposed in said cylindrical bore of said cartridge housing and wherein said injection needle comprises a hollow shaft, an internal end, an internal shaft portion, an external end, an external shaft portion, first and second apertures, and a passageway extending through said hollow shaft and connecting said first and second apertures, said needle being rigidly attached to and extending through said needle housing,

said internal end of said needle extending through said needle assembly housing toward said puncturable cartridge end stopper,

said external end of said needle extending toward said puncturable end cap of said cartridge housing without protruding therefrom,

said needle being adapted to expel a medicament from said cartridge,

said housing having locking means for irreversibly locking said needle assembly housing to said cartridge when said needle cap assembly and said cartridge are a predetermined distance apart.

8. The device of claim 7 wherein said first injection needle aperture is disposed in said internal needle shaft portion an appropriate distance from said housing to receive fluid from a punctured medicament cartridge, and

said second injection needle aperture is disposed in said external needle end.

9. The device of claim 7 wherein said first injection needle aperture is disposed in said internal needle shaft end, and

said second injection needle aperture is disposed in said external needle end.

10. The device of claim 1 wherein said cartridge housing further comprises

(G) a puncturable end cap, said end cap sealing said second end of said cartridge housing and having a needle guide disposed therein.

11. The device of claim 1 wherein said piston further comprises

(H) an operating shaft for operating said piston and said cartridge and for adapting said cartridge to other devices.

12. The device of claim 1 wherein said means fixedly attached to said cartridge housing for breaching a temporary sealing barrier between chambers of said slidable cartridge comprises a pushrod.

13. A mixing syringe for two-component medicaments comprising:

(A) a cartridge housing having a first end and a second end, said cartridge housing having a substantially cylindrical cartridge housing bore;

(B) a slidable cartridge disposed in said cartridge housing bore and having a first end, a second end, and a temporary sealing barrier disposed between said first and second ends and separating a cartridge bore of said cartridge into a cylindrical medicament solvent charge chamber and a cylindrical medicament charge chamber,

said cartridge housing having means connected thereto, for breaching said temporary sealing barrier,

said cartridge being suitable for separately storing a medicament solvent charge and a medicament charge in said medicament solvent charge chamber and said medicament charge chamber, respectively, said charges to be mixed to form a medicament to be expelled from said cartridge;

(C) a piston disposed within said first end of said cartridge and being slidably seated in said cartridge bore;

(D) a needle housing assembly rigidly attached to said cartridge and contained wholly within said cartridge housing;

(E) an injection needle which is containable wholly within said cartridge housing, which can be extended to a position in which at least a portion of said needle extends outside of said cartridge housing,

said needle being fixedly attached to said needle housing assembly and extending therethrough for injecting mixed medicament;

(F) a puncturable end cap, said end cap sealing said second end of said cartridge housing; and

(G) means for retracting said needle to reside completely within said cartridge housing after the expulsion of said medicament from said syringe;

said means for breaching the temporary sealing barrier between chambers of said slidable cartridge comprising a pushrod having an anchoring end and a puncturing end wherein said anchoring end is connected to said cartridge housing, said pushrod extending from said cartridge housing toward said cartridge puncturable end stopper;

said needle assembly housing having a pushrod aperture for freely guiding said pushrod therethrough so that said puncturing end of said pushrod resides in close proximity to and in alignment with said puncturable cartridge end stopper.