Disposable automatic injection device

• US 6,086,562 A
• Filed: 10/01/1998
• Issued: 07/11/2000
• Est. Priority Date: 10/27/1997
• Status: Expired due to Term

• Current Assignee: SARCOS LC (Sarcos Technology & Robotics Corp.)
• Original Assignee: Sarcos Incorporated (Rtx Corporation)
• Inventors: Best, Aaron M., Jacobsen, Stephen C., Petelenz, Tomasz J.
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US09/165,164
• Time in Patent Office: 649 Days
• Field of Search: 604/19, 604/22, 604/46, 604/47, 604/48, 604/51, 604/52, 604/69, 604/73, 604/130, 604/131, 604/132, 604/140, 604/141, 604/143-147, 604/156, 604/246, 604/257, 604/264, 604/272, 606/1, 606/167, 606/185, 600/573, 600/576
• US Class Current: 604/156
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 2005/3022 Worn on the body, e.g. as patches pressure infusion of the skin patch type A61M5/14248
• CPC Class Codes: A61M 2005/3123 having air entrapping or venting means, e.g. purging channels in pistons
• CPC Class Codes: A61M 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 2005/341 angularly adjustable or angled away from the axis of the injector
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/2046 Media being expelled from injector by gas generation, e.g. explosive charge
• CPC Class Codes: A61M 5/2066 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/282 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/286 upon internal pressure increase, e.g. pierced or burst A61M5/283 takes precedence
• CPC Class Codes: A61M 5/3234 Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis

Abstract

An automatic injection device includes a drug-filled vessel having a flexible membrane over a first opening thereof and a puncturable seal in a wall thereof, a hollow needle attached at a first end to the flexible membrane and having a sharp end positioned proximate the puncturable seal housing. A pressure source such as a combustible propellant provides a compressed gas above the flexible membrane to force the membrane into the drug-filled vessel, forcing the hollow needle through the puncturable seal and the drug contained in the vessel through the hollow needle. After the drug has been substantially evacuated from the vessel, the membrane is allowed to return to its pre-expanded state thus retracting the hollow needle into the vessel. Preferably, the flexible membrane is an elastomeric material having a plurality of concentrically configured corrugations to allow expansion of the membrane into the vessel. The inner surface of the vessel may have a dome-like shape such that expansion of the membrane into the vessel substantially matches the dome-like shape and thus forces substantially the entire amount of the drug from the vessel.

Claims

1. An apparatus for delivering a drug, comprising:

a housing defining a first opening at a proximal end thereof, having a distal end, and having an inner surface defining a chamber;

a puncturable seal secured to the distal end of said housing;

a resilient membrane having a first side and a second side and disposed within said chamber, said resilient membrane and said housing defining a drug reservoir between said first side of said resilient membrane and said inner surface and defining a pressure chamber between said second side of said resilient membrane and said inner surface;

a hollow needle having a distal end and a proximal end secured to said resilient membrane proximate said proximal end of said hollow needle and positioned with said distal end proximate said puncturable seal, having a first opening at said distal end, and a second opening in a side thereof proximate said proximal end; and

a pressure source in communication with said pressure chamber.

2. The apparatus of claim 1, wherein said housing is comprised of a drug containment portion secured relative to said first side of said resilient member and a cap portion secured relative to said second side of said resilient member.

3. The apparatus of claim 2, wherein said drug containment portion has a dome-like shape.

4. The apparatus of claim 3, wherein said hollow needle is secured to a mid-portion of said resilient member and said distal end of said hollow needle is positioned proximate a center of said dome-like shaped drug containment portion.

5. The apparatus of claim 1, wherein said housing is comprised of polyurethane.

6. The apparatus of claim 1, wherein said resilient member comprises an expandable structure.

7. The apparatus of claim 6, wherein said expandable structure is configured with a plurality of corrugations.

8. The apparatus of claim 7, wherein said plurality of corrugations are concentrically configured.

9. The apparatus of claim 1, wherein said resilient member is comprised of at least one of silicone, latex, rubber, and polyurethane.

10. The apparatus of claim 1, wherein said puncturable seal forms a seal at said distal end of said housing.

11. The apparatus of claim 10, wherein said puncturable seal is comprised of polyurethane.

12. The apparatus of claim 1, wherein said pressure source comprises a combustible propellant and an igniter in communication with said propellant.

13. The apparatus of claim 12, wherein said igniter comprises an electrical circuit including a first fusible link disposed adjacent said propellant for igniting said propellant.

14. The apparatus of claim 13, further comprising a second fusible link in communication with a vent defined in said housing and further including a meltable material disposed within said vent and in communication with said second fusible link.

15. The apparatus of claim 13, wherein said first fusible link comprises a resistor.

16. The apparatus of claim 1, wherein said hollow needle is comprised of stainless steel.

17. A drug delivery apparatus, comprising:

(a) vessel means for containing a drug therein;

(b) flexible expulsion means for expelling the drug from the vessel means, said flexible expulsion means is a diaphragm that is concentrically corrugated;

(c) forcing means for forcing the flexible expulsion means at least partially into said vessel means; and

(d) ejection means in fluid communication with said vessel means for delivering the drug from the vessel means.

18. The apparatus of claim 17, wherein said vessel means comprises a substantially rigid container.

19. The apparatus of claim 17, wherein said forcing means comprises a pressure source.

20. The apparatus of claim 19, wherein said pressure source comprises a propellant and an ignition source in communication with said propellant.

21. The apparatus of claim 19, wherein said pressure source comprises a compressed gas.

22. The apparatus of claim 17, wherein said ejection means comprises a hollow needle.

23. The apparatus of claim 22, further comprising a puncturable seal and said hollow needle includes a sharp end, said puncturable seal positioned on a wall of said vessel means proximate said sharp end of said hollow needle.

24. The apparatus of claim 17, wherein said flexible expulsion means forms a seal at an open end of said vessel means.

25. A drug delivery apparatus, comprising:

(a) a vessel, containing a drug therein;

(b) a diaphragm, having a concentrically corrugated shape, positioned to expel the drug from the vessel;

(c) a forcing device that biases the diaphragm at least partially into said vessel; and

(d) a hollow needle, coupled to the vessel to allow the drug to be expelled therefrom, having;

i) a first opening at a proximal end thereof that is secured to said diaphragm; and

ii) a second opening proximate the distal end and positioned within said vessel.

26. The apparatus of claim 25, wherein the forcing device comprises a pressure source.

27. The apparatus of claim 26, wherein the pressure source comprises a propellant and an ignition source in communication with the propellant.

28. The apparatus of claim 26, wherein the pressure source comprises a compressed gas.