Auto-injector device

• US 10,881,795 B2
• Filed: 01/20/2018
• Issued: 01/05/2021
• Est. Priority Date: 01/20/2017
• Status: Active Grant

• Current Assignee: L.G.P. Technology Holdings LLC
• Original Assignee: L.G.P. Technology Holdings LLC
• Inventors: Giambattista, Lucio
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Igel, Mark A
• Application Number:
  US16/479,510
• Publication Number:
  US 20190328968A1
• Time in Patent Office: 1,081 Days
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 2005/2073 preventing premature release, e.g. by making use of a safety lock
• CPC Class Codes: A61M 2005/2474 with movable piercing means, e.g. ampoule remains fixed or steady
• CPC Class Codes: A61M 2005/2492 via snap connection
• CPC Class Codes: A61M 2005/3142 Modular constructions, e.g. supplied in separate pieces to be assembled by end-user
• CPC Class Codes: A61M 2005/3206 Needle or needle hub disconnecting devices forming part of or being attached to the hub or syringe body
• CPC Class Codes: A61M 2005/3267 Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• 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 5/2455 with sealing means to be broken or opened
• CPC Class Codes: A61M 5/2466 by piercing without internal pressure increase A61M5/2429 takes precedence
• CPC Class Codes: A61M 5/315 Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
• CPC Class Codes: A61M 5/32 Needles; Details of needles pertaining to their connection with syringe or hub infusion needles A61M5/158; Accessories for bringing the needle into, or holding the needle on, the body A61M5/42, A61M5/46 take precedence; guide needles for catheters A61M25/065; Devices for protection of needles apparatus specially adapted for cleaning or sterilising needles A61M5/001
• 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 5/3221 Constructional features thereof, e.g. to improve manipulation or functioning
• CPC Class Codes: A61M 5/3243 being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel devices for protecting guide needles in combination with catheters A61M25/0612

Abstract

An auto-injector for hypodermic delivery of medication includes a first subassembly releasably coupled to a second subassembly. The first subassembly includes a cartridge holder configured to receive a medication cartridge, an injection needle through which medication can pass from the medication cartridge, and a needle shield movable between an extended position enclosing the needle and a retracted position in which a proximal end of the needle is not enclosed by the needle shield. The second subassembly includes a movable plunger rod positioned within a housing. Movement of the needle shield in a proximal direction from the retracted position to the extended position following administration of the medication automatically releases the first subassembly from the second subassembly. The released first subassembly is locked with the needle shield in the extended position. A new first subassembly containing an unused dosage of medication may be inserted and releasably connected to the second subassembly.

Claims

1. An auto-injector for hypodermic delivery of medication, comprising:

a first subassembly releasably coupled to a second subassembly;

wherein the first subassembly includes

a cartridge holder configured to receive a medication cartridge,

a hollow injection needle having a longitudinal cavity through which medication can pass from the medication cartridge, and

a needle shield moveable relative to the cartridge holder between an extended position enclosing the needle and a retracted position in which at least a proximal end of the needle is not enclosed by the needle shield; and

wherein the second subassembly includes

a housing, and

a moveable plunger rod positioned within the housing,

wherein movement of the needle shield in a proximal direction from the retracted position to the extended position will automatically disconnect the first subassembly from the second subassembly.

2. The auto-injector of claim 1, wherein the first subassembly further comprises:

a needle holder for retaining the needle, wherein the needle holder is moveable between a first position and a second position, wherein, in the first position, the needle cavity is not in fluid communication with an interior of the medication cartridge, and in the second position, the needle cavity is in fluid communication with the interior of the medication cartridge, and

a cap, releasably attached to the first subassembly, such that during removal of the cap from the first subassembly, the needle moves from the first position to the second position so as to cause a distal end of the needle to pierce a septum of the cartridge.

3. The auto-injector of claim 2, wherein the cap includes a cam follower for engaging a cam on the needle holder such that rotation of the cap in at least one direction causes distal movement of the needle holder and needle toward the second position.

4. The auto-injector of claim 2, wherein the cap includes a spring, such that rotation of the cap in at least one direction releases of the spring, which engages and causes distal movement of the needle holder and needle toward the second position.

5. The auto-injector of claim 1, wherein the first subassembly further comprises:

a shell, at least partially encompassing the cartridge holder and the needle shield, and

a cap, releasably attached to the first subassembly, wherein the cap releasably locks the shell and needle shield such that, when in place on the first subassembly, the cap prevents the needle shield and shell from moving relative to each other and, when the cap is removed from the first subassembly, the needle shield can move relative to the shell.

6. The auto-injector of claim 1, wherein distal movement of the needle shield from the extended position to the retracted position causes propulsion of medication through the needle.

7. The auto-injector of claim 6, wherein the second subassembly further comprises:

a plunger release latch positioned within the housing to releasably retain the plunger rod in a locked position,

wherein the cartridge holder is moveable between a first position and a second position proximal from the first position, such that, in the first position, the cartridge holder is prevented from moving in a proximal direction, and

wherein distal movement of the needle shield to the retracted position releases the cartridge holder from the first position and releases the latch to allow the plunger rod to move in the proximal direction and urge the cartridge holder from the first position to the second position.

8. The auto-injector of claim 7, wherein the first subassembly further comprises:

a shell, at least partially encompassing the cartridge holder and the needle shield,

wherein releasable engagement of the shell with the cartridge holder prevents the cartridge holder from moving in the proximal direction when the cartridge holder is in the first position.

9. The auto-injector of claim 8, wherein the cartridge holder includes at least one flexible tab that releasably engages the shell to prevent the cartridge holder from moving in the proximal direction when the cartridge holder is in the first position.

10. The auto-injector of claim 8, wherein the shell includes at least one flexible tab that releasably engages the cartridge holder to prevent the cartridge holder from moving in the proximal direction when the cartridge holder is in the first position.

11. The auto-injector of claim 6, wherein, after the plunger rod is released and causes the cartridge holder to move proximally from the first position to the second position, the plunger rod continues to move in the proximal direction to engage and move a stopper within the medicine cartridge.

12. The auto-injector of claim 1, wherein the first subassembly further comprises:

a shell, at least partially encompassing the cartridge holder and the needle shield,

wherein the shell includes at least one outwardly projecting flexible tab for engaging a corresponding at least one inwardly projecting retaining tab on the housing to releasably couple the first subassembly to the second subassembly.

13. The auto-injector of claim 12, wherein the second subassembly further comprises:

a movable ring that is biased in the proximal direction such that, when the needle shield moves proximally from the retracted position to the extended position, the ring engages the at least one flexible tab on the shell to disengage the at least one flexible tab from the corresponding at least one retaining tab on the housing.

14. The auto-injector of claim 13, wherein the needle shield includes an opening aligned with the flexible tab when the needle shield has moved from the retracted position to the extended position to allow the ring to cause the flexible tab on the shell to flex into the opening and disengage the flexible tab from the corresponding retaining tab on the housing.

15. The auto-injector of claim 1, wherein the needle shield includes at least one spline that travels within and is constrained by a corresponding groove formed in the shell, such that, when the needle shield moves from the retracted position to the extended position, the spline engages a tab on the shell extending into the groove to lock the needle shield in the extended position.

16. The auto-injector of claim 1, wherein the first subassembly is a single-use subassembly.

17. The auto-injector of claim 1, wherein the second subassembly is a multiple-use subassembly.

18. An auto-injector for hypodermic delivery of medication comprising:

a housing;

a medication cartridge positioned within the housing, the cartridge including a pierceable septum;

a cartridge holder positioned within the housing and configured to receive the medication cartridge, the cartridge holder being moveable between a first position and a second position proximal from the first position, wherein, in the first position, the cartridge holder is prevented from moving in a proximal direction;

a hollow injection needle having a longitudinal cavity therethrough and positioned within the housing, the needle being moveable between a first position and a second position, wherein, in the first position, the needle cavity is not in fluid communication with an interior of the cartridge, and in the second position, the needle cavity is in fluid communication with the interior of the cartridge;

a cap, releasably attached to the housing, such that during removal of the cap from the housing, the needle moves from the first position to the second position so as to cause a distal end of the needle to pierce the septum of the cartridge;

a moveable plunger rod positioned within the housing and biased to move in the proximal direction;

a plunger release latch positioned within the housing to releasably retain the plunger rod in a locked position; and

a moveable needle shield that moves from an extended position in which the needle shield is extended proximally beyond the needle to a retracted position where at least an end of the needle is exposed during injection; and

wherein retraction of the needle shield to the retracted position causes propulsion of medication through the needle and

wherein distal movement of the needle shield to the retracted position releases the cartridge holder from the first position and releases the latch to allow the plunger rod to move in the proximal direction and urge the cartridge holder from the first position to the second position.

19. The auto-injector of claim 18, further comprising:

a shell at least partially encompassing the cartridge holder and the needle shield; and

wherein releasable engagement of the shell with the cartridge holder prevents the cartridge holder from moving in the proximal direction when the cartridge holder is in the first position.

20. The auto-injector of claim 18, wherein, after the plunger rod is released and causes the cartridge holder to move to the second position, the plunger rod continues to move in the proximal direction to engage and move a stopper within the medicine cartridge.

21. The auto-injector of claim 18, further comprising:

a first subassembly releasably coupled to a second subassembly; and

wherein the first subassembly comprises the needle, the cartridge holder, the needle shield, and a shell, and the second subassembly comprises the housing, the moveable plunger rod, and the release latch.

22. The auto-injector of claim 21, wherein movement of the needle shield from the retracted position to the extended position will automatically release the first subassembly from the second subassembly.

23. The auto-injector of claim 21, wherein the first subassembly is a single-use subassembly.

24. The auto-injector of claim 21, wherein the second subassembly is a multiple-use subassembly.

25. An auto-injector for hypodermic delivery of medication, comprising:

a housing;

a cartridge holder positioned within the housing and configured to receive a medication cartridge, the cartridge holder being moveable between a first position and a second position proximal from the first position, wherein, in the first position, the cartridge holder is prevented from moving in a proximal direction;

a moveable plunger rod positioned within the housing and biased to move in the proximal direction;

a plunger release latch positioned within the housing to releasably retain the plunger rod in a locked position;

a hollow injection needle having a longitudinal cavity through which medication can pass from the medication cartridge; and

a needle shield movable relative to the cartridge holder between an extended position enclosing the needle and a retracted position in which at least an end of the needle is not enclosed by the needle shield;

a. wherein distal movement of the needle shield both releases the cartridge holder from the first position and releases the latch to cause the plunger rod to move in the proximal direction and urge the cartridge holder from the first position to the second position.

26. The auto-injector of claim 25, further comprising:

a shell, at least partially encompassing the cartridge holder and the needle shield; and

wherein releasable engagement of the shell with the cartridge holder prevents the cartridge holder from moving in the proximal direction when the cartridge holder is in the first position.

27. The auto-injector of claim 26, further comprising:

at least one flexible tab on the cartridge holder that releasably engages the shell to prevent the cartridge holder from moving in the proximal direction when the cartridge holder is in the first position.

28. The auto-injector of claim 26, further comprising:

at least one flexible tab on the shell that releasably engages the cartridge holder to prevent the cartridge holder from moving in the proximal direction when the cartridge holder is in the first position.

29. The auto-injector of claim 25, wherein, after the plunger rod is released and causes the cartridge holder to move to the second position, the plunger rod continues to move in the proximal direction to engage and move a stopper within the medicine cartridge.

30. The auto-injector of claim 25, further comprising:

a removable cap, releasably attached to the housing, such that during removal of the cap from the housing, the needle moves from a first position where the needle cavity is not in fluid communication with an interior of the cartridge to a second position where the needle cavity is in fluid communication with the interior of the cartridge.

31. The auto-injector of claim 30, further comprising:

a movable needle holder for retaining the needle; and

wherein the cap includes a cam follower for engaging a cam on the needle holder such that rotation of the cap in at least one direction causes distal movement of the needle holder and needle toward the second position.

32. The auto-injector of claim 30, further comprising:

a movable needle holder for retaining the needle; and

wherein the cap includes a spring such that rotation of the cap in at least one direction releases of the spring, which engages and causes distal movement of the needle holder from the first position toward the second position.

33. The auto-injector of claim 25, further comprising:

a shell, at least partially encompassing the cartridge holder and the needle shield; and

a removable cap, releasably attached to the housing, the cap releasably locking the shell and needle shield such that, when attached to the housing, the cap prevents the needle shield and shell from moving relative to each other and, when removed, the cap allows relative movement between the shell and needle shield.

34. The auto-injector of claim 25, further comprising:

a first subassembly releasably coupled to a second subassembly; and

wherein the first subassembly includes the needle, the cartridge holder, the needle shield, and a shell, and the second subassembly includes the housing, the moveable plunger rod, and the release latch.

35. The auto-injector of claim 34, wherein movement of the needle shield from the retracted position to the extended position will automatically release the first subassembly from the second subassembly.

36. The auto-injector of claim 35, wherein the first subassembly is a single-use subassembly.

37. The auto-injector of claim 35, wherein the second subassembly is a multiple-use subassembly.

38. The auto-injector of claim 35, wherein the shell includes at least one outwardly projecting flexible tab for engaging a corresponding at least one inwardly projecting retaining tab on the housing to releasably couple the first subassembly to the second subassembly.

39. The auto-injector of claim 38, wherein the second subassembly further comprises:

a ring that is biased in the proximal direction such that, when the needle shield moves from the retracted position to the extended position, the ring engages the at least one flexible tab on the shell to disengage the at least one flexible tab from the at least one retaining tab on the housing.

40. The auto-injector of claim 39, wherein the needle shield includes an opening aligned with the flexible tab when the needle shield has moved from the retracted position to the extended position to allow the ring to cause the flexible tab on the shell to flex into the opening and disengage the flexible tab from the corresponding retaining tab on the housing.

41. The auto-injector of claim 30, wherein the needle shield includes a spline that travels within and is constrained by a groove formed in the shell, such that, when the needle shield moves from the retracted position to the extended position, the spline engages a tab on the shell extending into the groove to lock the needle shield in the extended position.

42. A subassembly for an auto-injector, comprising:

a cartridge holder, configured to receive a medication cartridge;

a hollow injection needle having a longitudinal cavity therethrough through which medication can pass from the medication cartridge;

a needle shield movable relative to the cartridge holder between an extended position enclosing the needle and a retracted position in which at least an end of the needle is not enclosed by the needle shield;

a shell, at least partially encompassing the cartridge holder and the needle shield; and

a removable cap which releasably locks the shell and needle shield such that, when in place, the cap prevents the needle shield and shell from moving relative to each other and, when removed, allows relative movement between the shell and needle shield;

wherein the shell is configured to releasably connect to a second subassembly so as to form the auto-injector.

43. The auto-injector subassembly of claim 42, further comprising:

a needle holder for retaining the needle, wherein the needle holder is moveable between a first position and a second position, wherein, in the first position, the needle cavity is not in fluid communication with an interior of the medication cartridge, and in the second position, the needle cavity is in fluid communication with the interior of the medication cartridge.

44. The auto-injector subassembly of claim 43, wherein removal of the cap moves the needle holder from the first position to the second position such that needle cavity is in fluid communication with the interior of the medication cartridge.

45. The auto-injector subassembly of claim 44, wherein the cap includes a cam follower for engaging a cam on the needle holder such that rotation of the cap in at least one direction causes distal movement of the needle holder and needle toward the second position.

46. The auto-injector subassembly of claim 44, wherein the cap includes a spring, such that rotation of the cap in at least one direction releases of the spring, which engages and causes distal movement of the needle holder and needle toward the second position.

47. The auto-injector subassembly of claim 42, wherein the cartridge holder is moveable between a first position and a second position proximal from the first position, wherein, in the first position, the cartridge holder is prevented from moving in a proximal direction.

48. The auto-injector subassembly of claim 47, wherein a releasable locking member affixed to one of the cartridge holder or shell engages the other of the cartridge holder or shell to prevent relative motion between the cartridge holder and shell in at least one direction when the locking member is engaged.

49. The auto-injector subassembly of claim 48, wherein movement of the needle shield from the extended position to the retracted position disengages the releasable locking member to permit the cartridge holder to move in the proximal direction from the first position to the second position.

50. The auto-injection subassembly of claim 42, wherein the subassembly is a single-use subassembly.