Hypodermic drug delivery reservoir and apparatus

• US 8,684,968 B2
• Filed: 12/27/2007
• Issued: 04/01/2014
• Est. Priority Date: 12/29/2006
• Status: Active Grant

• Current Assignee: Aktivax, Inc.
• Original Assignee: Aktivpak, Inc.
• Inventors: Genosar, Amir
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): CHANDER, DIVA KAKAR
• Application Number:
  US12/521,743
• Publication Number:
  US 20100179473A1
• Time in Patent Office: 2,287 Days
• Field of Search: 604/70, 604/132, 604/133
• US Class Current: 604/132
• 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 2005/314 Flat shaped barrel forms, e.g. credit card shaped
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• 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 5/2425 by compression of deformable ampoule or carpule wall
• 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 5/282 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/284 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/286 upon internal pressure increase, e.g. pierced or burst A61M5/283 takes precedence
• 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 5/31531 Microsyringes, e.g. having piston bore diameter close or equal to needle shaft diameter
• 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 5/3234 : Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
• CPC Class Codes: A61M 5/3287 : Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence
• CPC Class Codes: A61M 5/427 : Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates

Abstract

A hypodermic drug delivery apparatus for delivering a pressurized medication fluid generally incorporates a reservoir containing at least one deliverable fluid, a reservoir pressurizing device, a rupturing member, a fluid administration device for communicating with the reservoir via a fluid passageway, and a rupture control mechanism for preventing rupture of a wall portion of the reservoir below a threshold pressure.

Claims

1. A drug delivery apparatus for delivering pressurized fluid, comprising:

a. at least one reservoir forming a sealed package for the fluid and comprising at least one rupturable wall portion;

b. a reservoir pressurizing device for pressurizing said reservoir;

c. at least one rupturing member for rupturing said rupturable wall portion;

d. at least one fluid administration device communicating with said reservoir via a fluid passageway;

e. a rupture control mechanism preventing rupture of the wall portion below a threshold pressure, whereby;

when the threshold pressure is reached, said wall portion may become ruptured by said rupturing member allowing the fluid to enter the fluid passageway and be delivered to a destination through said fluid administration device; and

f. a pressure chamber for use in pressurizing said reservoir, said rupture control mechanism including a resistance mechanism for preventing pressurization of the reservoir before a requisite pressure has been established in said pressure chamber, wherein said resistance mechanism comprises a collapsible spring disposed in said pressure chamber in confronting relationship to said reservoir, said collapsible spring operative to permit gradual pressure build up in said pressure chamber and to thereafter collapse and cause an instantaneous pressure in said reservoir.

2. A drug delivery apparatus according to claim 1 wherein said fluid administration device is selected from a group consisting of one or more needles, one or more micro-needles, one or more needleless-injector orifices, a spray nozzle, a dispersion nozzle, and an aerosolizing nozzle.

3. A drug delivery apparatus according to claim 1 including a stopper disposed in said pouch for preventing said rupturing member from further damaging said reservoir as fluid is expelled therefrom.

4. A drug delivery apparatus according to claim 1 wherein said rupture control mechanism includes a resilient member for resisting displacement of said rupturable wall portion toward said rupturing member.

5. A drug delivery apparatus according to claim 1 further comprising a cover and a base, said rupturing member formed integrally with said base.

6. A drug delivery apparatus according to claim 1 wherein said rupture control mechanism comprises a movable plate biased toward the reservoir and movable away from and towards its biased position in response to pressure in the reservoir.

7. A drug delivery apparatus according to claim 1 wherein said administration device has a pointed end that is movably disposed relative to an exterior surface of said delivery device between a retracted position wherein said pointed end is located within said delivery device and an extended position wherein said pointed end projects exteriorly of said delivery device, said pointed end operative to move from the retracted position to the extended position when the threshold pressure is reached, thereby activating said delivery apparatus.

8. A drug delivery apparatus according to claim 1 further comprising a pressure release device allowing controlled release of excess pressure from said pressure chamber.

9. A drug delivery device according to claim 1 further comprising a reservoir pressurizing device utilizing a pressure source selected from a group consisting of an internal or external chemical reaction, a combustion reaction, a pump, a liquid pump, a gas pump, a foot pump, a manual pump, and a syringe pump.

10. A drug delivery apparatus according to claim 1 wherein said reservoir comprises a plurality of compartments.

11. A drug delivery device according to claim 10 wherein said compartments are mixed prior to rupturing of the reservoir.

12. A drug delivery device according to claim 10 wherein the contents of said compartments are delivered sequentially.

13. A drug delivery apparatus according to claim 1 comprising an activation key formed as a coupling member configured for common movement with said rupturing member, said coupling member biased away from said reservoir.

14. A drug delivery device according to claim 1 wherein said fluid administration device includes a fluid conduit that defines said fluid passageway, said delivery device further comprising a non-return valve for preventing back flow into said reservoir.

15. A drug delivery apparatus according to claim 1 wherein said administration device is biased toward the reservoir and is movable away from and towards its biased position, to and from an administration position, by the presence of sufficient pressure in the reservoir.

16. A drug delivery apparatus according to claim 1 wherein said rupturable wall comprises a sealing member which seals around the rupturing member upon rupture.

17. A drug delivery apparatus according to claim 1 including a deliverable ingredient that mixes with the fluid from the reservoir and is delivered with the fluid through the administration device.

18. A drug delivery apparatus for delivering pressurized fluid, comprising:

a. at least one reservoir forming a sealed package for the fluid and comprising at least one rupturable wall portion;

b. a reservoir pressurizing device for pressurizing said reservoir;

c. at least one rupturing member for rupturing said rupturable wall portion;

d. at least one fluid administration device communicating with said reservoir via a fluid passageway;

e. a rupture control mechanism preventing rupture of the wall portion below a threshold pressure, whereby;

when the threshold pressure is reached, said wall portion may become ruptured by said rupturing member allowing the fluid to enter the fluid passageway and be delivered to a destination through said fluid administration device; and

f. an anti-abuse device to prevent extraction of fluid from the reservoir after administration has been completed.

19. A drug delivery apparatus for delivering pressurized fluid, comprising:

a. at least one reservoir forming a sealed package for the fluid and comprising at least one rupturable wall portion;

b. a reservoir pressurizing device for pressurizing said reservoir and operative to produce a pressure profile over time which controls timing of the reservoir'"'"'s rupture;

c. at least one rupturing member for rupturing said rupturable wall portion;

d. at least one fluid administration device communicating with said reservoir via a fluid passageway; and

e. a rupture control mechanism preventing rupture of the wall portion below a threshold pressure, whereby;

when the threshold pressure is reached, said wall portion may become ruptured by said rupturing member allowing the fluid to enter the fluid passageway and be delivered to a destination through said fluid administration device.