Hypodermic injection system

• US 20080015512A1
• Filed: 06/25/2007
• Published: 01/17/2008
• Est. Priority Date: 08/21/2001
• Status: Active Grant

• Current Assignee: D'Antonio Consultants International, Inc.
• Original Assignee: D'Antonio Consultants International, Inc.
• Inventors: D' Antonio, Linda, D' Antonio, Nicholas, Colvin, Richard
• Granted Patent: US 8,348,907 B2
• Time in Patent Office: Days
• US Class Current: 604/187
• CPC Class Codes: A61D 1/025 Vaccination appliances hypodermic syringes A61M
• CPC Class Codes: A61M 2005/005 Magazines with multiple ampoules directly inserted into an injection or infusion device, e.g. revolver-like magazines containing ampoules with or without needles
• CPC Class Codes: A61M 2209/086 Docking stations
• CPC Class Codes: A61M 5/001 Apparatus specially adapted for cleaning or sterilising syringes or needles
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• CPC Class Codes: A61M 5/2448 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules

Abstract

A hypodermic injection system particularly for use in mass immunizations having a handpiece with a grasping mechanism for holding ampules filled with injectate, a plunger for driving into the ampule to discharge the injectate in an injection process, an injection spring mechanism for driving the plunger, a motor and/or manual mechanism for cocking the injection spring mechanism, and an ampule ejection mechanism for ejecting ampules after use under control of a release mechanism. Ampules can be loaded, used and ejected without contact by the user of the system or the patient being injected. Also disclosed are a filling station for filling ampules through their injection orifices, and an arming device for setting the injection spring. Ampules are disclosed having a piston which is drivable towards an orifice to discharge injectate through the orifice. Ampules are also disclosed having enlarged proximal portions for easy grasping by the grasping mechanism of the injector. Ampules are further disclosed with separators for mixing lyophilized medication and a diluent. Further disclosed are magazines for holding ampules for sequential use by the hypodermic injector. The disclosed system finds particular use as a mass immunization kit for making numerous injections in the field.

Claims

1. A hypodermic injector for injecting fluid from an ampule loaded in said injector from a plurality of ampules in sequence, each ampule having a sealed condition for containing injectate in a sealed container and an empty condition where the injectate was discharged from the ampule without the necessity of human contact with the ampule before or after an injections, said injector comprising:

a grasping mechanism having a grasping condition for grasping an ampule and holding the ampule to receive an injectate discharge force, and an open condition, said grasping mechanism comprising;

gripper jaws having a closed position for gripping an ampule inserted in said grasping mechanism and an open position;

gripper jaw moving means actuable for moving said gripper jaws between the closed position; and

actuating means for actuating said gripper jaw moving means to move said gripper jaws from the open position to the closed position;

a plunger device movable from a set condition to a discharge condition for applying discharge force to an ampule in the sealed condition gripped in said gripper jaws to eject injectate from the ampule to render the ampule in the empty condition;

a first biasing device having a cocked condition for storing a biasing force in said device and a released condition, said first biasing device discharging force to said plunger device to move said plunger device from the set condition to the discharge condition in response to the movement of said biasing device from the cocked condition to the release condition;

a first cocking mechanism for moving said first biasing device from the release condition to the cocked condition;

a release mechanism actuatable for releasing said first biasing device from the cocked condition to the released condition to effect the movement of said plunger device from the set condition;

an ejector mechanism for ejecting an empty ampule from said grasping mechanism when said ejector mechanism is in the open condition, wherein said ejector mechanism comprises;

ejecting means movable from a set condition to an ejecting condition for ejecting an ampule from said gripper jaws when said gripper jaws are in their open position without requiring the user of said injector to touch the ampules;

a second biasing device releasable from a cocked condition to a release condition to drive said ejecting means to the ejecting condition to eject the ampule; and

a second cocking mechanism for moving said second biasing device from the released condition to the cocked condition.

2. A hypodermic injector according to claim 1 wherein said second cocking mechanism moves said second biasing device to the cocked condition in response to the loading of an ampule into said injector.

3. A hypodermic injector according to claim 1 wherein said ejector mechanism comprises:

a release member for discharging said second biasing device from the cocked condition, said release member being operable from the group consisting of manually operable or automatically operable.

4. A hypodermic injector according to claim 1 and further including a motor having a drive shaft operatively connected to said first cocking mechanism, said drive shaft being rotatable in one direction to cause said first cocking mechanism to assume the cocked position from the release position to move said first biasing device from the release condition to the cocked condition, and automatically rotatable in a reverse direction to reset said drive shaft for the next operation to cause said first cocking mechanism to assume the cocked condition.

5. A hypodermic injector according to claim 1 wherein said grasping mechanism assumes the open position when no ampule is grasped by said grasping mechanism, and wherein said grasping mechanism includes a disabling device for disabling said plunger device from moving from the set condition when no ampule is in said grasping mechanism and said grasping mechanism is in the open condition.

6. A hypodermic injector according to claim 1 wherein said hypodermic injector further includes both a remote motor, and a coupling mechanism for operatively coupling said motor to said first cocking device, and a handpiece with a housing for containing said grasping mechanism, plunger device, first biasing device, first cocking mechanism, release mechanism, ejector mechanism and second cocking mechanism.

7. A hypodermic injector according to claim 1 wherein the ampules have an outer wall with an interior chamber for containing the injectate, a proximal end and a distal end with an orifice in the distal end through which injectate can flow, the chamber extending between the distal end and the proximal end, and a piston movable from the proximal end towards the distal end to force injectate from the chamber through the orifice, wherein said injector further includes a motor having a drive shaft operatively connected to said first cocking mechanism, said drive shaft being rotatable in one direction to cause said first cocking mechanism to assume the cocked position from the release position, and said motor shaft being operatively connectable to the ampules and being rotatable in the reverse direction to draw the piston from the distal end of the ampule to the proximal end of the ampule to enable filling of the ampule with the injectate through the orifice.

8. A hypodermic injector according to claim 1 and further including a magazine for sequentially presenting an ampule to be grasped by the grasping mechanism from ampules held in sequence in a strip of ampules, said magazine comprising:

a housing having a holding region for holding a strip of ampules, a presenting region for making an ampule accessible to said grasping mechanism and walls for guiding a strip of ampules from said holding region in sequence to said presenting region;

a take-up spool for taking up portions of the ampule strip after ampules have been withdrawn from the strip by said grasping mechanism; and

a driving device for moving said take-up spool to receive the portions of the ampule strip after ampules have been withdrawn from the strip.

9. A hypodermic injector according to claim 8 wherein said housing comprises:

an access wall having access surfaces defining an opening to said presenting region wherein said grasping mechanism can grasp an ampule in said presenting region and withdraw the ampule from said magazine.

10. A hypodermic injector according to claim 8 wherein said walls define a curved, generally helical path for the ampule strip, wherein the ampule strip following the outermost part of said path locates the lead ampule in said presenting region to be grasped by said grasping mechanism, prior to the disposition of the ampule strip having had the ampule withdrawn therefrom on said take-up spool.

11. A hypodermic injector according to claim 10 wherein said magazine comprises:

a base portion having said walls extending therefrom, said walls further defining a compartment for holding said take-up spool; and

a cover portion having a funnel-shaped opening to said presenting area from which an ampule on the ampule strip extends from said presenting region to be grasped by said grasping mechanism.

12. A hypodermic injector according to claim 8 wherein said walls define at least one linear path in said housing for guiding the ampule strip towards said take-up spool, and wherein said presenting region is on said linear path adjacent to said take-up spool.

13. A hypodermic injector according to claim 12 wherein said walls define at least two parallel linear paths connected by a path interconnecting an adjacent end of said paths, wherein the ampule strip is movable along one linear path in one direction and along the adjacent path in the opposite direction, said linear paths terminating at said presenting region adjacent said take-up spool.

14. A hypodermic injector according to claim 13 wherein said housing comprises:

a base portion from which said walls extend, said base portion further having a take-up spool compartment for holding said take-up spool; and

a cover for said base portion, said cover having a funnel-shaped opening for receiving a portion of an ampule in said presenting region to provide access to said grasping mechanism to grasp the ampule.

15. A hypodermic injector according to claim 8 wherein said housing comprises an exterior wall having an opening to said presenting region for said grasping mechanism to grasp an ampule in said presenting region, and further comprising guiding walls for guiding said grasping mechanism to said opening to grasp an ampule.

16. A hypodermic injector according to claim 1 wherein said first biasing device is at least one spring having a biasing force sufficient to drive said plunger device with enough energy to eject injectate at jet velocity.

17. A hypodermic injector according to claim 1 and further including a perforator operatively connected to the ampule for injecting fluid injectate in response to the movement of said plunger device from the set condition to the discharge condition, said first biasing device driving said plunger device in an increasing manner during an injection process, to increase the discharge force applied by said plunger device to increase the pressure in the injectate fluid to increase the depth of injection in a body being injected as compared to the depth of injection by an injector having a diminishing discharge force.

18. An ampule for use with a hypodermic injector, said ampule comprising:

a body portion with a proximal end, a distal end and a longitudinal axis extending between said proximal end and said distal end, said body portion having a chamber having a relatively large opening in said proximal end and terminating before said distal end, and further having a relatively small orifice extending between the termination of said chamber and said distal end;

a frangible piston located in said chamber for moving in an injection stroke from said proximal end towards said orifice to drive injectate between said piston and said orifice through said orifice; and

structure for disabling said ampule upon completion of an injection with said ampule, said structure comprising apparatus for driving said piston beyond the injection stroke to destroy said piston at said orifice at the completion of an injection thus rendering said ampule incapable of reuse.

19. An ampule according to claim 18 wherein the hypodermic injector has a ram for pushing said piston from said proximal end towards said orifice to drive injectate through said orifice, and said ampule disabling structure comprises said piston being disabled, said piston being movable in response to the initial movement of the ram to drive injectate through said orifice, and said piston being disabled in response to the further movement of the ram to render said ampule inoperative for rendering said ampule incapable of reuse.

20. An ampule according to claim 18 and further including a perforator at the end of said orifice for penetrating the skin of a body being injected to control the injection depth and to reduce the force required to make the injection.

21. An ampule according to claim 20 wherein said ampule disabling structure comprises a disabling device substantially covering said perforator for disabling said ampule after an injection has been made using the ampule.

22. An ampule according to claim 21 wherein said disabling device is a collapsible cover for said perforator having a weakened wall which collapses upon the rendering of an injection to render said perforator inaccessible.

23. An ampule according to claim 20 wherein said perforator is the thickness of skin of the person or animals to be injected at the place of injection, the animals include dogs, cats, pigs, cows, horses, elephants, chickens, turkeys, roosters, geese, lobsters, crabs, goats, camels and sheep.

24. An ampule according to claim 23 wherein said perforator has a length of from 1.0 mm to 12.7 mm.

25. An ampule for a hypodermic injector, said ampule comprising:

a body portion having inside surfaces defining a chamber, said body portion having an orifice extending to said chamber at one end of the body portion defining a path for injectate during an injection;

a piston in said chamber extending between the inside surfaces of said body portion;

a portion of said chamber on one side of said piston for initially holding lyophilized medication;

a portion of said chamber on the other side of said piston for holding a diluent for the lyophilized medication;

structure for enabling flow and mixture of the diluent with the lyophilized medication in response to movement of said piston to prepare injectate to be discharged from said ampule; and

structure for disabling said ampule upon completion of an injection with said ampule.

26. An ampule according to claim 25 wherein said structure comprises a one-way valve on said piston for opening when the piston moves in a direction away from said orifice, and closing in response to movement of said piston towards said orifice to effect an injection.

27. An ampule for a hypodermic injector, said ampule comprising:

a body portion having inside surfaces defining a chamber, said body portion having an orifice extending to said chamber at one end of said body portion for discharging injectate during an injection; and

a piston located in said chamber extending between said inside surfaces and defining a cavity between said piston and said orifice for receiving lyophilized medication;

said orifice being able to receive diluent under pressure for mixing with the lyophilized medication in said cavity to form an injectate; and

said piston being movable away from said orifice in response to the entry of diluent into said cavity to enlarge the size of said cavity.

28. An ampule assembly for a hypodermic injector, said ampule assembly comprising:

a body portion having inside surfaces defining a first chamber, said body portion having an orifice extending to said first chamber at one end of said body portion defining a path for injectate during an injection;

an ampule piston in said first chamber extending between the inside surfaces of said body portion defining an ampule cavity between said ampule piston and said orifice; and

an appendage attachable to said body portion over said orifice, said appendage including;

interior surfaces defining a second chamber;

a discharge opening for connection to said orifice in said body portion;

an appendage piston extending across an end of said second chamber; and

a frangible separator extending across said second chamber and located between said appendage piston and said discharge opening to define a first appendage cavity between said separation and said appendage piston, and a second appendage cavity between said separator and said discharge opening;

at least one of said second appendage cavity and said ampule cavity being a receptacle for lyophilized medication and said first appendage cavity being a receptacle for diluent, said frangible cavity rupturing to effect the mixing of the lyophilized medication and the diluent to form an injectate in response to the application of sufficient force to said appendage piston, said ampule piston being movable in response to the flow of at least one of diluent or injectate through said orifice to increase the size of said ampule cavity; and

said appendage being detachable from said ampule to clear said orifice, and said ampule piston being movable towards said orifice to inject injectate through said orifice.

29. An ampule assembly according to claim 28 wherein said ampule cavity is the receptacle for the lyophilized medication, and the first appendage cavity is the initial receptacle for the diluent.

30. An ampule assembly according to claim 28 wherein said first appendage cavity is the initial receptacle for the diluent and said second appendage cavity is the initial receptacle for lyophilized medication.

32. One ampule according to claim 30 wherein said one cavity is between said orifice and said separator, and said second cavity is between said separator and said piston.

40. A hypodermic injector according to claim 32 wherein said biasing device moves said plunger device in an increasing manner during an injection process, to increase the discharge force applied by said plunger device to increase the pressure in the injectate fluid to increase the depth of the injection in a body being injected as compared to the depth of injection by an injector having a diminishing discharge force.

31. An ampule for a hypodermic injector, said ampule comprising:

a body portion having inside surfaces defining a chamber, said body portion having an orifice extending to said chamber at one end of said body portion for discharging injectate during an injection;

a piston located in said chamber extending between said inside surfaces;

a frangible separator extending between said inside surfaces and located between said orifice and said piston to separate said chamber into one cavity for holding lyophilized medication and a second cavity for holding a diluent, said separator being ruptured in response to the movement of said piston into one of said cavity when filled with one of the lyophilized medication and the diluent to effect mixing of the lyophilized medication and the diluent for ejecting through said orifice; and

structure for disabling said ampule upon completion of an injection with said ampule.

33. A magazine for mixing lyophilized medication and diluent in at least one ampule assembly, each assembly having an ampule with a body portion defining a first chamber having an inlet and outlet orifice at one end with a piston movable in said first chamber, said magazine comprising:

at least one collapsible storage container being connectable to the orifice, the container having collapsible walls defining a collapsible second chamber and a separator extending across the second chamber to separate the second chamber into one cavity for holding lyophilized medication and a second cavity for holding diluent and

a force transfer member for operative connection to said at least one collapsible storage container for collapsing the collapsible walls of said at least one container in response to the application of a sufficient force to said force transfer member to effect the mixing of the respective lyophilized medication and diluent in the respective ampule assemblies, and to fill the respective ampules with the mixed lyophilized medication and diluent through the respective orifices.

34. An arming station for setting an injection spring in a hypodermic injector to make the injector ready for an injection from a fired condition to a ready condition, the hypodermic injector having an ampule holding device for holding an ampule containing an injectate, apparatus for discharging the injectate upon the impact of a plunger at a predetermined end of the ampule, a plunger device for being driven into the predetermined end of the ampule to provide the impact to discharge the injectate, at least one spring having enough spring force upon the tensioning of the spring to a set condition to drive the plunger into the ampule to provide the impact to discharge the injectate and a spring holding device for holding the at least one spring in the ready condition, and a cocking member movable a predetermined amount to set the injection spring, said arming station comprising:

a rearming dock for holding a fired hypodermic injector in position to have the injector rearm to the ready condition;

a manual device for moving the cocking member by the predetermined amount to set the injection spring, said manual device including a manually movable gripping member for gripping the cocking member and moving it in response to the manual movement of the gripping member.

35. An arming station according to claim 34 wherein the cocking member is a draw rod which must be pulled for a predetermined distance to set the injection spring, and said manual device includes a device for gripping the draw rod and a lever for moving said gripping device by the predetermined distance to set the injection spring.

36. An arming station according to claim 34 and further including a pick-up cradle for holding a hypodermic injector having been rearmed to the ready condition pick-up for use as an injector.

37. A hypodermic injector for injecting fluid from an injection chamber having an exit nozzle in a sequential manner, each injection, occurring from the chamber without the necessity of human contact with the exit nozzle, the injection chamber or the injecting fluid, said injector comprising:

a plunger device movable from a set condition to a discharge condition for applying discharge force to the injection chamber to eject injectate fluid from the chamber; and

a biasing device having a drive shaft operatively connected to said plunger device to move said plunger device from the set condition to the discharge condition, and for moving said plunger device from the discharge condition to the set condition.

38. A hypodermic injector having a supply holding device for holding a supply wherein said supply includes a plunger in the supply, said injector having a fluid transfer device for transferring injectate fluid from a reservoir, said injector comprising a device for at least partially withdrawing the plunger from the supply to effect the transfer of injectate fluid from the reservoir to the supply, said injector having structure for slowly jogging the plunger towards the discharge condition to expel air from the supply.

39. A hypodermic injection system comprising:

a handpiece for receiving a cartridge containing an injectate, said handpiece having a cartridge holding device for holding a cartridge and an injectate discharge device actuable for effecting the discharge of injectate from a cartridge held by said cartridge holding device, a personally-operated arming apparatus remote from said handpiece, and an electrical connector for operably connecting said arming apparatus and said injectate discharge device for actuating said injectate discharge device in response to operation of said personally-operated arming device.

41. A crate assembly for holding ampules for withdrawal of ampules held in the crate assembly by a hypodermic injector ampule-grasping mechanism in an injection procedure, the ampules comprising a generally cylindrical body portion with a relatively narrow diameter extending from a forward portion towards a rearward portion and a wider portion having a peak near the rearward portion and a tapered rearwardly-extending surface extending from the peak to the rearward end of the ampule, said crate assembly comprising:

a support surface having a series of orifices defined by orifice surfaces having diameters slightly larger than the diameters of the forward portion of the ampule to provide sufficient contact between the respective orifice surfaces and the held ampules for holding the ampules with the forward end in a respective orifice to prevent the ampules from falling out of the orifices during ordinary use of said crate assembly during an injection procedure, and the wider portion of the ampule extending from said orifices in positions to be grasped by a hypodermic injector having an ampule-grasping mechanism.

42. The combination of a hypodermic injector for use with ampules and a crate assembly, said combination comprising:

a hypodermic injector for injecting fluid from an ampule loaded in said injector from a plurality of ampules in sequence, each ampule having a sealed condition for containing injectate in a sealed container and an empty condition where the injectate was discharged from the ampule without the necessity of human contact with the ampule before or after injection, each ampule further having a forward portion with a relatively narrow diameter, a rearward portion, and a wide peak near the rearward portion and a tapered rearwardly-extending surface extending from the peak to the rearward portion; and

said injector comprising;

a grasping mechanism having a grasping condition for grasping an ampule without the necessity of human contact and holding the ampule to receive an injectate discharge force, and an open condition;

a plunger device movable from a set condition to a discharge condition for applying discharge force to an ampule in the sealed condition to release injectate from the ampule to render the ampule in the empty condition;

a first biasing device having a cocked condition for storing a biasing force in said device and a released condition, said first biasing device discharging force to said plunger device to move said plunger device from the set condition to the discharge condition in response to the movement of said biasing device from the cocked condition to the release condition;

a first cocking mechanism having a cocked position and a release position, said first cocking mechanism to assume the cocked position from the release position for moving said first biasing device from the released condition to the cocked condition;

a first biasing device release mechanism actuatable for releasing said first biasing device from the cocked condition to the released condition to effect the movement of said plunger device from the set condition;

an ampule release mechanism for releasing an ampule in the empty condition from said grasping mechanism in the open condition, said ampule release mechanism including a release member movable from a set condition to a release condition for engaging and releasing an ampule from said injector, and a second biasing device releasable from a cocked condition to a released condition to drive said ampule release mechanism to release the ampule; and

a second cocking mechanism for moving said second biasing device from the released condition to the cocked condition; and

a crate assembly for holding ampules for withdrawal of ampules held in the crate assembly by a hypodermic injector ampule-grasping mechanism, said crate assembly comprising;

a support surface having a series of orifices having diameters slightly larger than the diameters of the forward portion of the ampule for holding the ampules with the forward end in a respective orifice and the wider portion of the ampule extending from said orifices in positions to be grasped by said ampule-grasping mechanism of said hypodermic injector.

43. An ampule for use with a hypodermic injector, said ampule comprising:

a body portion with a proximal end, a distal end and a longitudinal axis extending between said proximal end and said distal end, said body portion having a chamber having a relatively large opening in said proximal end and terminating before said distal end, and further having a relatively small orifice extending between the termination of said chamber and said distal end; and

a slidable spool located in said chamber between said piston and said proximal end, and a spring device associated with said spool locking said spool in said chamber against movement towards said proximal end;

said piston being slidable in said chamber from a position adjacent said orifice to said spool in response to the flow of injectate under pressure through said orifice; and

said spool forcing said piston towards said orifice by the high-speed impact of a plunger against said spool to force injectate through said orifice to effect an injection.