Automatic injection device

• US 8,679,061 B2
• Filed: 03/05/2008
• Issued: 03/25/2014
• Est. Priority Date: 06/30/2006
• Status: Active Grant

• Current Assignee: AbbVie Biotechnology Ltd. (Puerto Rico) (Abbvie Incorporated)
• Original Assignee: AbbVie Biotechnology Ltd. (Puerto Rico) (Abbvie Incorporated)
• Inventors: Julian, Joseph F., Bicknell, Stephen, Marshall, Jeremy, Rolfe, Steven
• Primary Examiner(s): Bosworth, Kami A
• Application Number:
  US12/074,704
• Publication Number:
  US 20100160894A1
• Time in Patent Office: 2,211 Days
• Field of Search: 604/131, 604134-137, 604/157, 604/187, 604/192, 604/197, 604/198, 604/218, 604/221, 604/224, 604/225, 604/229
• US Class Current: 604/136
• 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 2005/3125 specific display means, e.g. to indicate dose setting
• CPC Class Codes: A61M 2005/31508 provided on the piston-rod
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2209/02 Equipment for testing the apparatus
• 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 5/3129 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 5/3204 Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 37/06 Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: G09B 23/285 for injections, endoscopy, bronchoscopy, sigmoidscopy, insertion of contraceptive devices or enemas
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

An automatic injection device for providing a subcutaneous injection is disclosed. The device includes a syringe movably disposed in a housing and including a barrel portion, a needle and a bung for sealing the barrel portion. The device includes a plunger for moving the syringe towards a first open end of the housing such that the needle projects from the first end and subsequently applying pressure to the bung. The plunger includes a rod connected at a first end to the bung, a compressible expanded central portion, and a flange between a second end of the rod and the central portion. The device includes a biasing mechanism for biasing the plunger towards the first open end of the housing, the biasing mechanism disposed about the second end of the rod between the flange and the second end of the housing.

Claims

1. An automatic injection device for providing a subcutaneous injection of a substance into a user, comprising:

a housing having an open first end and a second end;

a syringe movably disposed in the housing, the syringe including a barrel portion for holding the substance, a hollow needle in fluid communication with the barrel portion for ejecting the substance from the syringe, and a bung for sealing the barrel portion and selectively applying pressure to the substance to force the substance through the hollow needle;

a syringe actuation component for first moving the syringe towards the first end of the housing such that the needle projects from the first end and for subsequently applying pressure to the bung, the syringe actuation component including a pressurizer, at a first end of the syringe actuation component, for selectively applying pressure to the bung, a rod comprising a compressible portion projecting from the rod along at least a portion of a length of the rod, the compressible portion having a first expanded position prior to entering the barrel portion of the syringe and a second compressed position for initiating movement of the bung and a flange between a second end of the syringe actuation component and the compressible portion; and

a first biasing mechanism for biasing the syringe actuation component towards the open first end of the housing, the first biasing mechanism disposed between the flange of the syringe actuation component and the second end of the housing.

2. The automatic injection device of claim 1, further comprising an activation button coupled to the housing for actuating the syringe actuation component.

3. The automatic injection device of claim 2, further comprising a latch for latching the syringe actuation component in a retracted position prior to actuation by the activation button.

4. The automatic injection device of claim 1, further comprising a window on the housing for viewing the interior of the housing.

5. The automatic injection device of claim 4, wherein the window has a substantially key-hole shape.

6. The automatic injection device of claim 4, wherein the window includes a fill line at a position in the window for indicating a full dose of a TNF inhibitor.

7. The automatic injection device of claim 1, further comprising an indicator for indicating when the syringe is empty.

8. The automatic injection device of claim 1, wherein the syringe contains a dose of a TNF inhibitor to be injected into a user.

9. The automatic injection device of claim 1, further comprising a removable cap for covering one of the first end of the housing or the second end of the housing.

10. The automatic injection device of claim 1, further comprising a needle sheath that advances over the needle projecting through the first end after ejection of the substance from the syringe.

11. The automatic injection device of claim 1, further comprising a dose of a TNF inhibitor loaded in the barrel portion of the syringe.

12. The automatic injection device of claim 1, wherein the compressible portion extends along a longitudinal length of the rod between a lower solid portion of the rod forming the pressurizer and an upper solid portion of the rod.

13. The automatic injection device of claim 1, wherein the compressible portion comprises:

a central void extending at least along a portion of the syringe actuation component; and

one or more flexible elbows provided on either side of the central void, wherein the one or more elbows project radially outwardly from the central void when the compressible portion is in the first expanded position, and wherein the one or more elbows are collapsed radially inwardly toward the central void when the compressible portion is in the second compressed position.

14. The automatic injection device of claim 1, wherein the flange is configured to hold the first biasing mechanism in a compressed position until actuation of the automatic injection device.

15. The automatic injection device of claim 1, wherein the syringe actuation component further comprises:

a base extending distally from the flange toward the second end of the housing, the base configured to support the first biasing mechanism.

16. The automatic injection device of claim 15, wherein the base comprises:

one or more flexible legs around which the first biasing mechanism coils.

21. An automatic injection device of any one of claims 1 or 17 comprising a dose of a TNFα

inhibitor.

22. The automatic injection device of claim 21, wherein the TNFα

inhibitor is selected from the group consisting of an anti-TNFα

antibody, or an antigen-binding portion thereof, a TNF fusion protein, or a recombinant TNF binding protein.

23. The automatic injection device of claim 22, wherein the TNF fusion protein is etanercept.

24. The automatic injection device of claim 22, wherein the TNFα

inhibitor is selected from the group consisting of infliximab, CDP 571, CDP 870, anti-TNF dAb, golimumab, adalimumab, etanercept, p55TNFRIgG and r-TBP-1.

25. The automatic injection device of claim 22, wherein the anti-TNFα

antibody, or antigen-binding portion thereof, is selected from the group consisting of a chimeric antibody, a humanized antibody, a human antibody and a multivalent antibody.

26. The automatic injection device of claim 25, wherein the human anti-TNFα

antibody, or antigen-binding portion thereof, is selected from the group consisting of;

i) a human TNFα

antibody, or antigen binding portion thereof, that dissociates from human TNFα

with a K_d of 1×

10<sup>−

8</sup> M or less and a K_off rate constant of 1×

10<sup>−

3</sup> s<sup>−

1</sup> or less, both determined by surface plasmon resonance, and neutralizes human TNFα

cytotoxicity in a standard in vitro L929 assay with an IC₅₀ of 1×

10<sup>−

7</sup> M or less;

ii) a human TNFα

antibody, or antigen binding portion thereof, that;

a) dissociates from human TNFα

with a K_off rate constant of 1×

10<sup>−

3</sup> s<sup>−

1</sup> or less, as determined by surface plasmon resonance;

b) has a light chain CDR3 domain comprising the amino acid sequence of SEQ ID NO;

3, or modified from SEQ ID NO;

3 by a single alanine substitution at position 1, 4, 5, 7 or 8 or by one to five conservative amino acid substitutions at positions 1, 3, 4, 6, 7, 8 and/or 9;

c) has a heavy chain CDR3 domain comprising the amino acid sequence of SEQ ID NO;

4, or modified from SEQ ID NO;

4 by a single alanine substitution at position 2, 3, 4, 5, 6, 8, 9, 10 or 11 or by one to five conservative amino acid substitutions at positions 2, 3, 4, 5, 6, 8, 9, 10, 11 and/or 12;

iii) a human TNFα

antibody, or antigen binding portion thereof, that comprises a light chain variable region (LCVR) comprising the amino acid sequence of SEQ ID NO;

1 and a heavy chain variable region (HCVR) comprising the amino acid sequence of SEQ ID NO;

2; and

iv) adalimumab.

27. The automatic injection device of claim 26, further comprising 40 mg of adalimumab.

28. The automatic injection device of claim 22, wherein the anti-TNFα

antibody, or antigen-binding portion thereof, is selected from the group consisting of infliximab, golimumab, and adalimumab.

29. An automatic injection device of any one of claim 1 or 17, wherein the substance is a formulation comprising adalimumab, sodium chloride, monobasic sodium phosphate dihydrate, dibasic sodium phosphate dihydrate, sodium citrate, citric acid monohydrate, mannitol, polysorbate 80, and water.

30. The automatic injection device of claim 29, wherein the automatic injection device comprises a 40 mg dose of adalimumab.

31. The automatic injection device of claim 29, further comprising sodium hydroxide.

32. An article of manufacture comprising:

a) a packaging material; and

b) an automatic injection device of any one of claim 1 or 17 comprising a dose of a TNFα

inhibitor.

33. An article of manufacture comprising an alcohol prep and a dose tray, wherein the dose tray comprises any one of the automatic injection devices of claim 1 or 17 comprising a dose of a TNFα

inhibitor.

34. A method of using the automatic injection device of any one of claim 1 or 17 for administering a TNF inhibitor to a user.

17. An automatic injection device for providing a subcutaneous injection of a substance into a user, comprising:

a housing having an open first end and a second end;

a plunger including a rod configured to be connected or adjacent at a first end to a bung of a syringe, a compressible portion projecting from the rod along at least a portion of a length of the rod, the compressible portion having a first expanded inactivated position and a second compressed activated position for initiating movement of the bung, and a flange between a second end of the rod and the compressible portion; and

a biasing mechanism for biasing the plunger towards the open first end of the housing, the biasing mechanism disposed about the second end of the rod between the flange and the second end of the housing.

18. The automatic injection device of claim 17, further comprising an activation button coupled to the housing for actuating the plunger.

19. The automatic injection device of claim 18, further comprising a latch for latching the plunger in a retracted position prior to actuation by the activation button.

20. The automatic injection device of claim 17, further comprising a window on the housing for viewing the interior of the housing.

35. An automatic injection device for providing a subcutaneous injection of a substance into a user, comprising:

a housing comprising;

an open first end,

a second end,

a window disposed in a side wall for viewing the interior of the housing, and

an indicator that aligns with the window when the substance has been injected into the user;

a syringe movably disposed in the housing, the syringe comprising;

a barrel portion for holding the substance,

a hollow needle in fluid communication with the barrel portion for ejecting the substance from the syringe, and

a bung for sealing the barrel portion and selectively applying pressure to the substance to force the substance through the hollow needle;

a syringe actuation component for first moving the syringe towards the open first end of the housing such that the needle projects from the open first end and for subsequently applying pressure to the bung, the syringe actuation component comprising;

a rod comprising;

an upper solid portion having a first end,

a lower solid portion having a second end operable to move the bung and to transmit an expulsion force thereto,

a projecting portion projecting from the rod along at least a portion of a length of the rod, the projecting portion comprising two or more flexible elbows on either side of a central void provided between the upper and lower solid portions and aligned along a central axis of the rod, the projecting portion having a first expanded position prior to entering the barrel portion of the syringe in which the flexible elbows project radially outwardly to form the central void, and the projecting portion having a second compressed position for applying the second end of the lower solid portion to the bung in which the flexible elbows are compressed radially inwardly toward the central void, and

a flange disposed between the first end of the upper solid portion of the rod and the projecting portion of the rod;

a first biasing mechanism for biasing the syringe actuation component towards the open first end of the housing, the first biasing mechanism disposed between the flange of the syringe actuation component and the second end of the housing;

a second biasing mechanism for holding the syringe retracted in the housing until the first biasing mechanism is released; and

a first removable cap for covering the open first end of the housing or the second end of the housing.

36. The automatic injection device of claim 35, wherein the central void is a longitudinally extending slit.

37. The automatic injection device of claim 35, wherein the housing is fixed relative to the syringe.

38. The automatic injection device of claim 35, further comprising:

an activation button coupled to the housing for actuating the syringe actuation component.

39. The automatic injection device of claim 38, further comprising:

a latch for latching the syringe actuation component in a retracted position prior to actuation by the activation button.

40. The automatic injection device of claim 35, wherein the syringe contains a dose of a TNF inhibitor to be injected into a user.

41. The automatic injection device of claim 35, further comprising:

a dose of a TNF inhibitor pre-loaded in the barrel portion of the syringe.

42. The automatic injection device of claim 41, wherein the TNF inhibitor comprises adalimumab.

43. The automatic injection device of claim 35, further comprising:

a needle sheath configured to advance over the needle projecting through the open first end of the housing after ejection of the substance from the syringe.