Apparatus and method for rapid auto-injection of medication

• US 6,979,316 B1
• Filed: 05/23/2002
• Issued: 12/27/2005
• Est. Priority Date: 05/23/2002
• Status: Expired due to Term

• Current Assignee: Seedlings Life Science Ventures LLC
• Original Assignee: Seedlings Life Science Ventures LLC
• Inventors: Rubin, Keith H., Sellers, James M., Taylor, Haydn B.
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): Maiorino, Roz
• Application Number:
  US10/154,202
• Time in Patent Office: 1,314 Days
• Field of Search: 604131-138, 604/198, 604185-189, 604/232, 604/139, 604141-156, 604246-249, 60416701-16705, 604/19, 604/48, 604/65, 604/93.01, 604/140, 604173-174, 604/157, 604/197, 604/201, 604/811, 604/110, 604/181
• US Class Current: 604/156
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 2005/314 Flat shaped barrel forms, e.g. credit card shaped
• CPC Class Codes: A61M 2005/3247 Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
• CPC Class Codes: A61M 2205/587 Lighting arrangements
• CPC Class Codes: A61M 2205/6063 Optical identification systems
• 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 5/24 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 5/282 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/283 by telescoping of ampoules or carpules with the syringe body
• CPC Class Codes: A61M 5/286 upon internal pressure increase, e.g. pierced or burst A61M5/283 takes precedence
• CPC Class Codes: A61M 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/326 Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
• CPC Class Codes: A61M 5/3271 with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position

Abstract

An auto-injector for rapid delivery of a bolus of injectable medication has a generally flat, sealed housing with small peripheral dimensions, approximating those of a credit card. A syringe, configured to be contained within the flat housing is pre-filled with the medication. The housing contains a mechanism that, when triggered, automatically drives the syringe and needle forwardly to an injection position and then continues to compress the volume of the syringe to effect rapid injection. The forward injection end of the device includes an actuator that also conceals and protects the needle at all times and, prevents post-injection hazards. The flat faces of the device have graphic symbols and other visual indicia relating to the operation and condition of the device. The device enables a simple three-step operation that reduces the risk of improper use.

Claims

1. A device for automatic rapid injection of a bolus of medication comprising:

a flat, rigid housing having front and back walls spaced to define the thickness of the housing, the housing having logitudinally disposed forward and rearward ends;

a syringe adapted to contain an injectable medication, the syringe including a syringe body having a longitudinally compressible volume to enable a predetermined volume of injectable medication to be forced out of the syringe and an injection needle arranged to communicate with the interior of the syringe body, the flow path from the syringe body and through the needle being dimensioned to permit rapid delivery of the medication, both of the syringe body and the needle being disposed within the housing in a retracted position, the syringe being movable longitudinally as a unit from the retracted position to an injection position in which the needle extends longitudinally beyond the forward end of the housing to penetrate tissue; and

at least a portion of the syringe body being movable rapidly and longitudinally, after the needle has been extended to the injection position, to compress the syringe volume by a predetermined volume and eject a bolus corresponding to that predetermined volume.

2. A device as defined in claim 1 wherein the volume defined within the syringe is greater than the predetermined volume of the bolus to be injected.

3. A device as defined in claim 1 wherein the extended length of the needle is intramuscular injection.

4. A device as defined in claim 1 wherein the extended length of the needle is selected to effect a subcutaneous injection.

5. A device as defined in claim 1 further comprising a self-contained power source in the housing for effecting movement of the syringe forwardly to the extended position.

6. A device as defined in claim 5 wherein the power source comprises a spring.

7. A device as defined in claim 6 wherein the spring is substantially compressed when the syringe is in its retracted position.

8. A device as defined in claim 1 wherein the geometry of the syringe body is containable in a flat rectangular envelope that, in turn, is containable within the flat housing.

9. A device as defined in claim 1 further comprising:

the interior of the syringe body being sealed from the needle when the device is in its retracted configuration, the seal being adapted to maintain the seal until the syringe has moved to the injection position.

10. A device as defined in claim 1 wherein the syringe comprises a collapsible wall.

11. A device as defined in claim 10 wherein the syringe body is flat.

12. A device as defined in claim 10 wherein the collapsible wall comprises a portion of the syringe body being a collapsible bellows.

13. A device as defined in claim 1 wherein the syringe comprises a container having a closed end and an open end, and a plunger closing the open end and being slidable in the container whereby the interior volume of the syringe may be compressed.

14. A device as defined in claim 13 wherein the syringe body is flat.

15. A device as defined in claim 14 wherein the syringe further comprises a relatively rigid container having front and back walls and a peripheral wall extending along the sides and rear end of the container.

16. A device as defined in claim 15 further comprising:

a flow passage in the plunger, the flow passage terminating in a sealed, pierceable septum at the forward end of the plunger; and

a double ended injection needle having a sharp rear end adapted to pierce the septum.

17. A device as defined in claim 16 further comprising:

a collapsible needle support mounted to and extending from the forward region of the plunger, the needle being secured to the needle support with the rear end of the needle in spaced, aligned relation to the septum, the needle support being collapsible in response to engagement of the needle support with an abutment within the housing when the syringe has been advanced to its injection position whereby the septum is impaled on the proximal end of the needle to establish fluid communication between the needle and the interior of the syringe body.

18. A device as defined in claim 5 further comprising a restraint for preventing movement of the syringe beyond its injection position and wherein the self-contained power source first moves the syringe to the injection position and thereafter compresses the syringe volume.

19. A device as defined in claim 5 wherein the needle, in its injection position, projects beyond the forward end of the housing, the device further comprising an actuator movably mounted in the housing and having a portion extending from the forward end of the housing, the actuator being adapted to enable operation of the power source to move the syringe forwardly in response to pressing of the forwardly extending portion of the actuator against an injection site.

20. A device as defined in claim 19 wherein the actuator comprises a portion of an actuator assembly, the actuator assembly comprising:

a forward portion that includes the actuator;

a pair of arms extending rearwardly from the actuator and being contained within the housing, the rear ends of the arms having a latch component operatively associated with the syringe for maintaining the syringe in its retracted position;

the actuator assembly being movable rearwardly in relation to the housing, the latch component being responsive to such relative rearward movement to unlatch the syringe, thereby enabling the power source to effect movement of the syringe to the injection position and to compress the syringe volume.

21. A device as defined in claim 20 wherein the latch component comprises:

a finger pivotably attached to the rear ends of each arm, each finger being pivotable in a laterally outward direction;

the housing having internal guide surfaces engageable with the fingers and oriented to guide the fingers in said pivotal movement in response to rearward movement of the actuator assembly, the latching components comprising detent surfaces on the fingers that release the syringe for movement to an injection position.

22. A device as defined in claim 20 wherein the syringe is attached to a syringe carrier, for movement within the syringe, the carrier being in engagement with the power source;

the carrier having a latch component releasably engageable by the latch component of the actuating assembly when the device in its storage configuration; and

guide surfaces disposed within the housing and engageable with the syringe carrier to guide the carrier from its retracted position to its injection position.

23. A device as defined in claim 22 further comprising a detent mounted in the housing and engageable with the actuator assembly to releasably maintain the actuator assembly in its storage position;

the detent being engageable with the syringe carrier, as the syringe carrier advances to the injection position, to release the detent and permit movement of the actuator assembly; and

means for biasing the actuator assembly in a forward direction whereby upon release of the detent, the actuator assembly may move forwardly in the housing to cause additional forward extension of the actuator with respect to the housing.

24. A device as defined in claim 23 wherein the forwardly extending portion of the actuator has sufficient length to extend beyond and completely enclose the forward tip of the needle.

25. A device as defined in claim 24 further comprising the detent being constructed to reengage the actuator assembly when the actuator has advanced to its fully extended position, thereby locking the actuator in its needle enclosing position.

26. A device as defined in claim 1 wherein the housing has front and back faces and further comprising at least one of the front and back face having graphic indicia in the form of a pictogram illustrating instruction for use of the device.

27. A device as defined in claim 1 wherein the housing has the front and back faces and where at least one of the faces of the housing has a window, the syringe body having a portion sufficiently transmissive to light so that when the syringe is in the retracted position, the light transmissive portion of the syringe is in registry with the window to enable observation of at least some characteristics of the contents of the syringe.

28. A device as defined in claim 1 further comprising a cover detachably connected to the housing and covering the region from which the needle projects from the housing.

29. A device as defined in claim 28 further comprising a seal extending between the cover and the housing.

30. A device as defined in claim 29 wherein the cover has a rearwardly facing opening adapted to receive the forward end of the housing in a snap-fit.

31. A device as defined in claim 30 wherein the snap fit connection further comprises:

the housing having a circumferential groove formed in its forward region;

the portion of the cover that defines its open end comprising a peel-away strip connected to the cover by a thin, manually tearable connector, the peel-away strip having an inwardly directed latch member engageable in a snap-fit with the circumferential groove, the engagement between the latching member and the groove being constructed to require peeling away of the strip to permit removal of the cover.

32. A device as defined in claim 31 wherein the absence of the peel-away strip may serve as a tamper-evident indication.

33. A device as defined in claim 1 in which the housing has a length in the range of about 2.8 to about 3.8 inches, a width in the range of about 1.7 to about 3.5 inches and a thickness in the range of about 0.20 to about 0.75 inch.

34. A device as defined in claim 1 in which the body of the syringe is flat and is contained within the housing.

35. A device as defined in claim 1 further comprising:

a needle shield movably mounted with respect to the housing from a storage position to an extended position in which the shield completely covers the needle in an injection position, the needle shield being flat and having biohazard indicia imprinted thereon, the biohazard indicia being concealed within the housing when the device is in its storage configuration and being exposed exteriorly of the housing when the needle shield is in its extended needle-covering position.

36. A device as defined in claim 1 further comprising:

an actuator movably mounted within the housing and having a forward portion that projects forwardly beyond the forward end of the housing, the actuator being operatively coupled with the power source within the housing to trigger movement of the syringe to an injection position and cause injection of medication;

the forward portion of the actuator having an appearance that contrasts with the appearance of the housing as to provide prominent distinguishing identification of the forward tip of the actuator while the device is in its retracted position.

37. A device as defined in claim 36 further comprising a cover attached to and covering the forward region of the housing, at least a portion of the cover being transparent to enable the forward tip of the actuator to be viewed.

38. A device as defined in claim 36 further comprising:

the actuator being movable to a fully extended position to expose a rearward portion of the actuator, beyond the forward end of the housing, the rearward portion having a biohazard sharp warning thereon;

the actuator, when in its fully extended position, extending beyond the forward end of the needle to cover the needle.

39. A device as defined in claim 38 further comprising:

means biasing the actuating member to its fully extended position.

40. A device as defined in claim 19 wherein the actuating member has a generally flat face and has a longitudinally extending passage in alignment with the injection needle, the actuating member being supported for longitudinal movement in a forward direction, sufficient to completely shield the forward portion of the needle when the needle is in its injection position.

41. A device as defined in claim 40 further comprising indicia on the flat face of the actuating member, the indicia being concealed normally within the housing before the device has effected injection and being exposed externally of the housing after the injection has been completed and the actuating member has been extended to cover the needle.

42. A device as defined in claim 1 further comprising:

an injectable medication contained within the syringe.

43. A device as defined in claim 42 wherein the injectable medication is selected from the group consisting of anticholinergic medication, anti-arrhythmics, drugs for the treatment of multiple sclerosis, cholinomimetics, anti-nausea and gastrointestinal stimulants, diuretics, sedatives and hypnotics, anti-psychotic agents, analgesics, anti-migraine medication, hypocalcemic drugs, corticosteroids, anti-anxiety and anti-vertigo drugs, vaccines, antibiotics, antitoxins, contraceptives, anticoagulants, insulin, anti-seizure medications, growth hormone, anti-diuretic hormone, injectable vitamins, erythropoietin, interlukens, colony stimulating factor, monoclonal antibodies and fusion inhibitors.

44. A device as defined in claim 42 wherein the medication comprises epinephrine.

45. A device as defined in claim 1 wherein the housing has a substantially card-like shape.