Auto-Injector Apparatus

• US 20100137832A1
• Filed: 11/24/2009
• Published: 06/03/2010
• Est. Priority Date: 11/25/2008
• Status: Active Grant

• Current Assignee: Mylan Specialty L.P. (Pfizer Inc.)
• Original Assignee: Meridian Medical Technologies Incorporated
• Inventors: Harvey, Oliver T., Reber, Dominic C., Hill, Robert L., Mathews, Colin J., Hurlstone, Chris J., Wilmot, John G., Stewart, James R. JR., Mesa, Clarence M., Turner, Ben G.
• Granted Patent: US 8,690,836 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/202 cocking means, e.g. to bias the main drive spring of an injector
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 2205/8287 operated by an external magnetic or electromagnetic field
• 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 5/145 using pressurised reservoirs, e.g. pressurised by means of pistons
• CPC Class Codes: A61M 5/148 flexible, e.g. independent bagsA61M5/155 takes precedence
• CPC Class Codes: A61M 5/1483 using flexible bags externally pressurised by fluid pressure
• CPC Class Codes: A61M 5/152 pressurised by contraction of elastic reservoirs containers for dispensing contents by contraction of an elastic bag provided therein, in general B65D83/0061
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• 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 5/2425 by compression of deformable ampoule or carpule wall
• CPC Class Codes: A61M 5/2459 upon internal pressure increase, e.g. pierced or burst A61M5/2429 takes precedence
• CPC Class Codes: A61M 5/31 Details
• 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 5/34 Constructions for connecting the needle , e.g. to syringe nozzle or needle hub connecting catheter tubes to hubs A61M25/0014

Abstract

An auto-injector apparatus includes a flexible container containing a liquid medicant, a needle communicated with a container, a housing with a container being received in the housing, a pump disposed in the housing and positioned to engage the flexible container and expel the medicant from the container through the needle upon relative movement between the pump and the container, and a main drive spring operably associated with the needle to extend the needle from a first needle position wherein the needle is completely received in the housing to a second needle position wherein the needle protrudes from the housing. The pump may be a roller.

Claims

1. An auto-injector apparatus, comprising:

a flexible container containing a liquid medicant;

a needle communicated with the container;

a housing, the container being received in the housing;

a pump disposed in the housing and positioned to engage the flexible container and expel the medicant from the container through the needle upon relative movement between the pump and the container; and

a main drive spring operably associated with the needle to extend the needle from a first needle position wherein the needle is completely received in the housing to a second needle position wherein the needle protrudes from the housing.

2. The apparatus of claim 1, wherein:

the main drive spring is operably associated with the pump to create the relative movement between the pump and the flexible container.

3. The apparatus of claim 2, further comprising:

a retraction spring operably associated with the needle to retract the needle back into the housing after the medicant is expelled from the container.

4. The apparatus of claim 3, wherein:

the housing further comprises a housing body having a housing interior and an opening, and a housing lid movably attached to the housing body, the lid being movable between a closed position closing the opening and an open position wherein the housing interior is accessible through the opening.

5. The apparatus of claim 4, further comprising:

a cocking linkage connecting the lid to the main drive spring and the retraction spring so that opening of the lid extends the main drive spring and the retraction spring.

6. The apparatus of claim 1, further comprising:

a container carriage reciprocably disposed in the housing, the container being received in the carriage so that the carriage, the container and the needle are movable together within the housing between first and second carriage positions corresponding to the first and second needle positions.

7. The apparatus of claim 6, further comprising:

a needle return chassis;

a retraction spring connected between the housing and the needle return chassis;

an interlock operably associated with the needle return chassis and the container carriage, the interlock releasing the needle return chassis after the pump expels the medicant from the container so that the retraction spring can withdraw the needle return chassis, the container carriage, the container and the needle to a safety position wherein the needle is fully received back in the housing.

8. The apparatus of claim 6, wherein:

the pump includes a roller;

the container carriage includes a roller track; and

the roller is received in the roller track so that the roller is guided by the roller track as the roller rolls over the flexible container.

9. The apparatus of claim 8, further comprising:

a roller interlock between the roller and the container carriage to prevent the roller from rolling over the flexible container until after the main drive spring moves the needle to its second needle position.

10. The apparatus of claim 1, wherein:

the flexible container and the needle are connected together as part of a replaceable cartridge assembly replaceably received in the housing; and

the pump and the main drive spring are connected to the housing for multiple use with sequential replaceable cartridge assemblies.

11. The apparatus of claim 1, further comprising:

a needle hub connected to the flexible container, the needle being attached to the needle hub and including a needle proximal end extending proximally from the needle hub; and

a needle protection frame slidably connected to the needle hub, the needle hub being slidable relative to the frame from a first hub position wherein the frame extends proximally beyond the needle proximal end, to a second hub position wherein the needle proximal end extends proximally beyond the frame.

12. The apparatus of claim 11, further comprising:

a collapsible needle sheath supported by the frame and covering the needle to aid in maintaining sterility of the needle when the needle hub is in its first hub position relative to the frame.

13. The apparatus of claim 1, wherein:

the main drive spring comprises a coiled spring strip.

14. The apparatus of claim 1, wherein:

the housing comprises a closed single use housing having an interior inaccessible by a user without damage to the housing.

15. The apparatus of claim 14, further comprising:

the housing having a transparent window therein through which the flexible container is visible; and

an opaque secondary container in which the housing is sealed.

16. The apparatus of claim 14, further comprising:

the housing having a transparent window therein through which the flexible container can be viewed; and

a pull strip movable between a first position blocking the transparent window and a second position wherein the transparent window is unblocked so that the flexible container can be viewed prior to use.

17. The apparatus of claim 1, wherein the pump comprises a roller.

18. The apparatus of claim 17, wherein:

the roller has a rotational axis, and the relative movement between the roller and the container is a relative longitudinal movement in a longitudinal direction transverse to the rotational axis, and the container is longitudinally fixed relative to the housing during at least part of the relative longitudinal movement between the roller and the container.

19. The apparatus of claim 17, wherein:

the roller has a rotational axis, and the relative movement between the roller and the container is a relative longitudinal movement in a longitudinal direction transverse to the rotational axis, and the roller is longitudinally fixed relative to the housing during at least part of the relative longitudinal movement between the roller and the container.

20. The apparatus of claim 19, wherein:

the roller includes two spaced co-axial roller portions; and

the needle extends between the roller portions.

21. The apparatus of claim 1, wherein the pump comprises an inflatable balloon.

22. The apparatus of claim 1, wherein the pump comprises a pair of magnets on opposite sides of the flexible container.

23. The apparatus of claim 1, wherein the pump comprises an electro-magnet and a magnetically attracted mass on opposite sides of the flexible container.

24. The apparatus of claim 1, wherein the pump comprises a source of fluid pressure communicated with the interior of the flexible container.

25. An auto-injector apparatus, comprising:

a housing having a proximal end and a distal end;

a container carriage reciprocably disposed in the housing, the container carriage including a cavity adapted to receive a medicant container, the container carriage being movable within the housing between first and second carriage positions;

a roller disposed in the housing and positioned to roll proximally through the cavity of the container carriage to expel medicant from the container; and

a main drive spring operably associated with the carriage to move the carriage proximally from its first position to its second position.

26. The apparatus of claim 25, wherein:

the main drive spring is operably associated with the roller to roll the roller through the cavity of the container carriage after the container carriage is moved to its second carriage position.

27. The apparatus of claim 26, further comprising:

a retraction spring operably associated with the container carriage to move the carriage back from its second carriage position toward its first carriage position after the roller rolls through the cavity of the container carriage.

28. The apparatus of claim 25, further comprising:

a retraction spring operably associated with the container carriage to move the carriage back from its second carriage position toward its first carriage position after the roller rolls through the cavity of the container carriage.

29. The apparatus of claim 28, wherein:

the housing further comprises a housing body having a housing interior and an opening, and a housing lid movably attached to the housing body, the lid being movable between a closed position closing the opening and an open position wherein the housing interior and the cavity of the container carriage are accessible through the opening so that a medicant container can be placed in the cavity of the container carriage.

30. The apparatus of claim 29, further comprising:

a cocking linkage connecting the lid to the main drive spring and the retraction spring so that opening of the lid extends the main drive spring and the retraction spring.

31. The apparatus of claim 25, further comprising:

a return chassis;

a retraction spring connected between the housing and the return chassis; and

an interlock operably associated with the return chassis and the container carriage, the interlock releasing the return chassis after the roller rolls through the cavity of the container carriage, so that the retraction spring can move the return chassis and the container carriage distally within the housing.

32. The apparatus of claim 25, wherein:

the container carriage includes a roller track; and

the roller is received in the roller track so that the roller is guided by the roller track as the roller rolls through the cavity of the container carriage.

33. The apparatus of claim 32, further comprising:

a roller interlock between the roller and the container carriage to prevent the roller from rolling through the cavity of the container carriage until after the main drive spring moves the container carriage to its second carriage position.

34. The apparatus of claim 25, further comprising:

a medicant container filled with medicant received in the cavity of the container carriage;

a needle attached to the medicant container and extending in a proximal direction, the needle being dimensioned such that the needle is contained in the housing when the container carriage is in its first position and such that the needle extends out of the proximal end of the housing when the container carriage is in its second position; and

wherein the housing comprises a closed single use housing having an interior inaccessible by a user without damage to the housing.

35. The apparatus of claim 25, wherein:

the main drive spring comprises a coiled spring strip.

36. The apparatus of claim 35, wherein:

the roller comprises a cylindrical roller rotatably connected to the coiled spring strip.

37. The apparatus of claim 35, wherein:

the roller comprises an integral coil of the coiled spring strip.

38. A method of auto-injecting a liquid medicant into a patient, comprising:

(a) placing a proximal end of an auto-injector apparatus against the patient'"'"'s body;

(b) releasing a main drive spring;

(c) driving a needle proximally within the apparatus with the main drive spring so that the needle extends out of the proximal end of the apparatus, thereby inserting the needle in the patient'"'"'s body; and

(d) creating relative motion between a pump and a flexible medicant container within the apparatus and thereby forcing the medicant out of the flexible medicant container through the needle into the patient'"'"'s body.

39. The method of claim 38, wherein:

step (d) occurs after step (c).

40. The method of claim 38, wherein:

step (d) occurs at least partly simultaneously with step (c).

41. The method of claim 38, wherein:

the relative motion of step (d) is driven by the main drive spring.

42. The method of claim 38, further comprising:

(e) after step (d), releasing a retraction spring and retracting the needle back into the apparatus with the retraction spring.

43. The method of claim 42, further comprising:

opening a lid of the apparatus to provide access to an interior of the apparatus;

extending the main drive spring and the retraction spring via the action of opening the lid, so that the springs are in position to repeat steps (c), (d) and (e); and

removing the medicant container and needle from the apparatus and placing a replacement medicant container and needle assembly into the apparatus.

44. The method of claim 38, further comprising:

during step (d), breaking a frangible seal within the flexible medicant container, so that the medicant can flow from the container to the needle.

45. The method of claim 38, wherein:

in step (d) the pump includes a roller and the relative motion includes rolling the roller across the flexible container.

46. An auto-injector apparatus, comprising:

a flexible container containing a liquid medicant;

a needle communicated with the container;

a roller positioned to engage the flexible container and expel the medicant from the container upon relative movement in a displacement direction between the roller and the container, the roller having a rotational axis transverse to the displacement direction; and

wherein the flexible container has a width transverse to the displacement direction, the width varying along the displacement direction.

47. The apparatus of claim 46, further comprising:

a main drive operably associated with the roller to move the roller relative to the container from a first engagement position relative to the container to a second engagement position relative to the container.

48. The apparatus of claim 47, wherein:

the width of the container at the second engagement position is greater than the width of the container at the first engagement position, so that a speed of injection of medicant increases during relative movement between the first and second engagement position.

49. The apparatus of claim 48, wherein:

the width of the container continuously increases from the first engagement position to the second engagement position.

50. The apparatus of claim 47, wherein:

the width of the container at the second engagement position is less than the width of the container at the first engagement position, so that a speed of injection of medicant decreases during relative movement between the first and second engagement positions.

51. The apparatus of claim 50, wherein:

the width of the container continuously decreases from the first engagement position to the second engagement position.