Needleless hypodermic injection device

• US 5,064,413 A
• Filed: 11/09/1989
• Issued: 11/12/1991
• Est. Priority Date: 11/09/1989
• Status: Expired due to Term

• Current Assignee: Bioject Incorporated
• Original Assignee: Bioject Incorporated
• Inventors: Nakagawa, Takaaki, McKinnon, Charles M., Wilcox, Carl E.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): CERMAK, ADAM
• Application Number:
  US07/434,250
• Time in Patent Office: 733 Days
• Field of Search: 604/68-72, 604/140, 604/141, 604/143, 604/228, 604/232, 222/389
• US Class Current: 604/70
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 5/2053 Media being expelled from injector by pressurised fluid or vacuum for infusion A61M5/145, A61M5/155
• CPC Class Codes: A61M 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
• CPC Class Codes: A61M 5/486 Indicating injection pressure

Abstract

A needleless injection device has a housing containing a pilot valve connectable to a compressed gas source. A main valve is operatively connected to the pilot valve. The pilot valve and main valve form a two-stage valve with the pilot valve activatable to open the main valve utilizing gas pressure. Compressed gas in a reservoir flows through the open main valve to driven a plunger into an ampule to inject an injectant through a patient'"'"'s skin.

Claims

1. An injection device comprising:

a housing;

a plunger driver slidably disposed within said housing;

a pilot valve within said housing connectable to a compressed gas source; and

a main valve having a substantially unbiased main valve piston, said main valve operatively connected to said pilot valve, said pilot valve activatable to open said main valve such that compressed gas may flow by said main valve to drive said plunger driver.

2. The injection device of claim 1 further comprising:

a cartridge holder attachable to said housing and having a cartridge chamber;

a valve body disposed within said housing; and

a gas delivery tube connecting said cartridge chamber and said valve body.

3. The injection device of claim 2 further comprising a piercing body spaced apart from said valve body and forming a reservoir therebetween.

4. The injection device of claim 2 further comprising a gas filter associated with said gas delivery tube.

5. The injection device of claim 2 further comprising at least one bleed hole in said gas delivery tube.

6. The injection device of claim 1 further comprising a liner having a liner seat, and a main valve piston with said main valve piston and said liner seat comprising said main valve.

7. The injection device of claim 3 wherein at least said liner and said main valve piston form an annular chamber between said liner and said main valve piston with said annular chamber connected by at least one gas passageway to said reservoir.

8. The injection device of claim 7 wherein said gas passageway comprises a slot on said valve body.

9. The injection device of claim 6 wherein said main valve piston has a sealing face including an elastomeric seal.

10. The injection device of claim 1 wherein said pilot valve comprises a Schrader-type poppet valve.

11. An injection device comprising:

a housing;

a plunger driver within said housing;

a valve body within said housing;

a pilot valve within a pilot valve chamber in said valve body;

a main valve having a main valve seat within said housing and a substantially unbiased main valve piston sealingly engageable to said main valve seat;

a gas delivery tube connectable to a compressed gas source and joined to said pilot valve chamber and said main piston chamber, said gas delivery tube having a bleed hole leading to a reservoir;

said pilot valve activatable to create a gas pressure difference on opposite sides of said main valve causing it to separate from said valve seat such that compressed gas in said reservoir is released to drive said plunger driver.

12. An injection device comprising:

a housing;

a plunger driver slidably positioned within said housing;

a piercing body within said housing;

a valve body in said housing spaced apart from said piercing body;

a gas delivery tube extending from said piercing body to said valve body;

a reservoir formed at least by said valve body and said housing, said gas delivery tube having a bleed hole opening to said reservoir;

a pilot valve substantially disposed in a pilot valve chamber in said valve body;

a main valve seat;

a main valve piston slidably disposed within said housing and sealingly engageable against said main valve seat;

said main valve piston having a first chamber on a first side thereof, said first chamber connected to said reservoir via a gas passageway, said main valve piston having a second chamber on a second side thereof, said second chamber connecting to said pilot valve chamber;

said pilot valve activatable to vent said pilot valve chamber thereby causing said main valve piston separate from said main valve seat such that compressed gas from said reservoir flows past said main valve piston into a plunger chamber to drive said plunger driver.

13. The injection device of claim 12 further comprising a sleeve section on said valve body with said main valve piston slidably displaceable within said sleeve section.

14. An injection method comprising the steps of:

positioning a nozzle of an injection device onto an injection site;

activating a biased pilot valve of the device; and

allowing an unbiased main valve of the device to open in response to activation of the pilot valve, thereby allowing compressed gas to pass by the main valve to drive injectant from the nozzle.

15. The method of claim 14 further comprising the step of supplying compressed gas to the pilot valve.

16. The method of claim 15 further comprising the step of supplying compressed gas from the reservoir around the pilot valve to the main valve via a gas passageway.

17. The method of claim 14 further comprising the step of supplying compressed gas to a reservoir.

18. The method of claim 14 wherein compressed gas is supplied to the pilot valve by connecting a compressed gas cartridge to a gas delivery tube leading to the pilot valve.

19. The method of claim 18 further comprising the step of bleeding gas from the gas delivery tube to the reservoir.

20. The method of claim 14 further comprising the step of metering the compressed gas supplied to the pilot valve by passing it through an orifice.

21. The method of claim 14 wherein said nozzle is on an ampule releasably attached to the injection device, further comprising the step of using the compressed gas flowing by the main valve to drive a plunger into the ampule.

22. A method of intramuscular and subcutaneous injection comprising the steps of:

installing an ampule containing an injectant and having a nozzle into a holder on an injector;

placing the nozzle of the ampule onto an injection site;

activating a biased pilot valve to vent a pilot valve chamber;

opening an unbiased main valve with a gas pressure difference across opposite sides of the main valve resulting from activation of the pilot valve; and

driving a plunger into the ampule with gas pressure developed by compressed gas flowing past the main valve to drive the injectant out of the ampule through the nozzle.

23. The method of claim 22 further comprising the step of connecting a compressed gas source to the pilot valve chamber, a reservoir and a seat chamber.

24. An injection device assembly comprising:

a device housing;

a pilot valve within said device housing connectable to a compressed gas source;

an ampule for holding an injectant, said ampule having a nozzle, and said ampule attachable to said device housing;

an unbiased main valve operatively connected to said pilot valve, said pilot valve activatable to open said main valve such that compressed gas may flow by said main valve to drive an injectant from said nozzle.

25. An injection device comprising:

a housing;

a plunger driver slidably disposed within said housing;

a pilot valve within said housing connectable to a compressed gas source;

a main valve operatively connected to said pilot valve, said pilot valve activatable to open said main valve such that compressed gas may flow by said main valve to drive said plunger driver;

a cartridge holder attachable to said housing and having a cartridge chamber;

a valve body disposed within said housing;

a gas delivery tube connecting said cartridge chamber and said valve body;

a piercing body spaced apart from said valve body and forming a reservoir therebetween; and

a spacer disposed within said reservoir to limit the volume of said reservoir.

26. An injection device comprising:

a housing;

a plunger driver slidably disposed within said housing;

a pilot valve within said housing connectable to a compressed gas source;

a liner having a liner sheet;

a main valve piston having a central counterbore, said main valve piston and said liner seat comprising a main valve;

said main valve operatively connected to said pilot valve, and said pilot valve activatable to open said main valve such that compressed gas may flow by said main valve to drive said plunger driver.

27. An injection method comprising the steps of:

positioning a nozzle of an injection device onto an injection site;

activating a pilot valve of the device;

allowing a main valve of the device to open in response to activation of the pilot valve, thereby allowing compressed gas to pass by the main valve to drive injectant from the nozzle;

supplying compressed gas to a reservoir; and

adjusting the volume of the reservoir.

28. An injection method comprising the steps of:

connecting a compressed gas cartridge to a gas delivery tube leading to the pilot valve, to supply compressed gas to a pilot valve within an injection device;

filtering the compressed gas supplied to the delivery tube;

positioning a nozzle of the injection device onto an injection site;

activating a pilot valve of the device;

allowing a main valve of the device to open in response to activation of the pilot valve, thereby allowing compressed gas to pass by the main valve to drive injectant from the nozzle;

29. A method of intramuscular and subcutaneous injection comprising the steps of:

installing an ampule containing an injectant and having a nozzle into a holder on an injector;

placing the nozzle of the ampule onto an injection site;

activating a pilot valve to vent a pilot valve chamber;

opening a main valve with a gas pressure difference across opposite sides of the main valve resulting from activation of the pilot valve;

driving a plunger into the ampule with gas pressure developed by compressed gas flowing past the main valve to drive the injectant out of the ampule through the nozzle;

releasing the pilot valve and resealing the pilot valve chamber;

refilling the pilot valve chamber with compressed gas; and

closing the main valve.

30. A method of intramuscular and subcutaneous injection comprising the steps of:

installing an ampule containing an injectant and having a nozzle into a holder on an injector;

connecting a compressed gas source to a pilot valve chamber, a reservoir and a seat chamber within the injector;

placing the nozzle of the ampule onto an injection site;

activating a pilot valve to vent a pilot valve chamber;

opening a main valve with a gas pressure difference across opposite sides of the main valve, resulting from activation of the pilot valve;

driving a plunger into the ampule with gas pressure developed by compressed gas flowing past the main valve, to drive the injectant out of the ampule through the nozzle;

selecting an ampule opening and a spacer for the reservoir for one of intramuscular and subcutaneous injection.