Autoinjector apparatus

• US 10,092,706 B2
• Filed: 04/20/2012
• Issued: 10/09/2018
• Est. Priority Date: 04/20/2011
• Status: Active Grant

• Current Assignee: Amgen Inc.
• Original Assignee: Amgen Inc.
• Inventors: Denzer, Michael, Swift, Robert W., Johnston, Neal D., Ganzitti, Gabriele, Ewing, Kenneth R., Krishna, Suhas
• Primary Examiner(s): OSINSKI, BRADLEY JAMES
• Application Number:
  US14/112,479
• Publication Number:
  US 20150045729A1
• Time in Patent Office: 2,363 Days
• CPC Class Codes: A61J 1/065 Rigid ampoules, e.g. glass ampoules
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 2005/208 Release is possible only when device is pushed against the skin, e.g. using a trigger which is blocked or inactive when the device is not pushed against the skin
• CPC Class Codes: A61M 2005/2407 from the rear
• CPC Class Codes: A61M 2005/2496 via pivot
• CPC Class Codes: A61M 2005/3247 Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
• CPC Class Codes: A61M 2205/0216 Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
• CPC Class Codes: A61M 2205/121 interface between cassette and base
• CPC Class Codes: A61M 2205/123 with incorporated reservoirs
• CPC Class Codes: A61M 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/586 Ergonomic details therefor, e.g. specific ergonomics for left or right-handed users
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6036 characterised by physical shape, e.g. array of activating switches
• CPC Class Codes: A61M 2205/6045 having complementary physical shapes for indexing or registration purposes
• CPC Class Codes: A61M 2205/8206 battery-operated
• 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 5/3204 Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices
• CPC Class Codes: A61M 5/326 : 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
• CPC Class Codes: A61M 5/50 : having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile retractable needles or needle protectors with means for preventing re-use A61M5/321

Abstract

An autoinjector apparatus is disclosed which comprises a single-use cassette and an autoinjector. The cassette comprises a housing and a sleeve movably disposed in the housing. A syringe may be disposed in the sleeve and secured therein with a lock cap. The lock cap is affixed to a distal end of the sleeve and contacts the distal end of the syringe. A shield remover extends through an opening in a proximal end of the housing for removing a needle shield which covers a needle of the syringe. A cassette identification arrangement is provided on a surface of the housing to enable the autoinjector to identify the cassette. The autoinjector is provided with a detector for reading the cassette identification arrangement.

Claims

1. A single-use cassette for use with an autoinjector, the cassette comprising:

a housing;

an inner sleeve disposed in the housing and movable between first and second positions,

a syringe disposed in the inner sleeve;

a lock cap for securing the syringe in the inner sleeve, the lock cap including an elastomeric bumper, the lock cap affixed to a distal end of the inner sleeve with the elastomeric bumper contacting a distal end of the syringe, wherein the distal end of the inner sleeve comprises at least one receptacle and the lock cap comprises at least one arm member for inserting into the receptacle; and

a shield remover extending through an opening in a proximal end of the housing for removing a needle shield from the syringe, wherein the shield remover comprises an elongated body having a proximal end and a distal end, the distal end comprising at least one flexible tongue that expands outwardly when the shield remover is removed from the cassette to prevent the shield remover from being reinserted into the cassette.

2. The cassette of claim 1, wherein the at least one arm member of the lock cap comprises a barb arrangement for gripping an inner surface of the at least one receptacle of the inner sleeve.

3. The cassette of claim 1, wherein the shield remover comprises a spring-biased tab, the tab disposed within an aperture defined in a wall of the housing.

4. The cassette of claim 1, wherein the syringe includes a barrel and an injection needle.

5. The cassette of claim 1, further comprising a therapeutic product in the syringe.

6. The cassette of claim 5, wherein the therapeutic product is selected from the group consisting of Epogen®

, Aranesp®

, Enbrel®

, Neulasta®

, Neupogen®

, Nplate®

, Vectibix®

, Sensipar®

, Xgeva® and

Prolia®

.

7. The cassette of claim 5, wherein the therapeutic product is an antibody to IL-17 Receptor A, an antagonist of angiopoietin-2, a TNF blocker or inhibitor.

8. The cassette of claim 7, wherein the therapeutic product is a TNF blocker or inhibitor and is etanercept, adalimumab, certolizumab, golimumab or infliximab.

9. The cassette of claim 1, further comprising a cassette identification arrangement on a surface of the housing to enable the autoinjector to identify the cassette.

10. The cassette of claim 9, wherein the cassette identification arrangement comprises at least one projection.

11. An apparatus for injection of a therapeutic product, the apparatus comprising:

an autoinjector; and

a single-use cassette for use with the injector, the cassette comprising;

a housing;

an inner sleeve disposed in the housing and movable between first and second positions;

a syringe disposed in the inner sleeve;

a lock cap for securing the syringe in the inner sleeve, the lock cap including an elastomeric bumper, the lock cap affixed to a distal end of the inner sleeve with the elastomeric bumper contacting a distal end of the syringe, wherein the distal end of the inner sleeve comprises at least two receptacles and the lock cap comprises at least arm members, each inserted into one of the receptacles; and

a shield remover extending through an opening in a proximal end of the housing for removing a needle shield from the syringe, wherein the shield remover comprises a spring-biased tab, the tab disposed within an aperture defined in a wall of the housing to prevent removal of the shield remover from the cassette, and wherein the shield remover comprises an elongated body having a proximal end and a distal end, the distal end comprising at least one flexible tongue that expands outwardly when the shield remover is removed from the cassette to prevent the shield remover from being reinserted into the cassette.

12. The apparatus of claim 11, wherein each arm member of the lock cap comprises a barb arrangement for gripping an inner surface of the corresponding receptacle of the inner sleeve.

13. The apparatus of claim 11, wherein the shield remover comprises a spring-biased tab, the tab disposed within an aperture defined in a wall of the housing to prevent removal of the shield remover from the cassette.

14. The apparatus of claim 13, wherein the autoinjector comprises a pin for pushing the tab out of the aperture defined in the wall of the housing when the cassette is placed in the injector to thereby allow the shield remover to be removed from the cassette.

15. The apparatus of claim 11, further comprising a therapeutic product in the syringe.

16. The apparatus of claim 15, wherein the therapeutic product is selected from the group consisting of Epogen®

, Aranesp®

, Enbrel®

, Neulasta®

, Neupogen®

, Nplate®

, Vectibix®

, Sensipar®

, Xgeva®

, and Prolia®

.

17. The apparatus of claim 15, wherein the therapeutic product is an antibody to IL-17 Receptor A, an antagonist to angiopoietin-2, or a TNF blocker or inhibitor.

18. The apparatus of claim 15, wherein the therapeutic product is a TNF blocker or inhibitor and is etanercept, adalimumab, certolizumab, golimumab or infliximab.

19. The apparatus of claim 11, further comprising a cassette identification arrangement on a surface of the housing to enable the autoinjector to identify the cassette.

20. The apparatus of claim 19, wherein the cassette identification arrangement comprises at least one projection or a detector for reading the cassette identification arrangement to identify the cassette.

21. An apparatus for injection of a therapeutic product, the apparatus comprising:

an autoinjector; and

a single-use cassette for use with the injector, the cassette comprising;

a housing;

a sleeve disposed in the housing and movable between first and second positions;

a syringe disposed in the sleeve; and

a shield remover extending through an opening in a proximal end of the housing for removing a needle shield from the syringe, the shield remover comprising a spring-biased tab, the tab disposed within an aperture defined in a wall of the housing to prevent removal of the shield remover from the cassette;

wherein the autoinjector comprises a pin for pushing the tab out of the aperture defined in the wall of the housing when the cassette is placed in the injector to thereby allow the shield remover to be removed from the cassette.

22. The apparatus of claim 21, wherein the shield remover comprises a spring-biased tab, the tab disposed within an aperture defined in a wall of the housing to prevent removal of the shield remover from the cassette.

23. The apparatus of claim 21, wherein the shield remover comprises an elongated body having a proximal end and a distal end, the distal end comprising at least one flexible tongue that expands outwardly when the shield remover is removed from the cassette to prevent the shield remover from being reinserted into the cassette.

24. The apparatus of claim 21, further comprising a therapeutic product in the syringe, wherein the therapeutic product is Epogen®

, Aranesp®

, Enbrel®

, Neulasta®

, Neupogen®

, Nplate®

, Vectibix®

, Sensipar®

, Xgeva®

, Prolia®

, an antibody to IL-17 Receptor A, an antagonist to angiopoietin-2, a TNF blocker or inhibitor, etanercept, adalimumab, certolizumab, golimumab, or infliximab.

25. A single-use cassette for use with an autoinjector, the cassette comprising:

a housing;

a sleeve disposed in the housing and movable between first and second positions, wherein the sleeve is capable of having a syringe disposed therein; and

a shield remover extending through an opening in a proximal end of the housing for removing a needle shield from the syringe, the shield remover comprising an elongated body having a proximal end and a distal end, the distal end comprising at least one flexible tongue that expands outwardly when the shield remover is removed from the cassette to prevent the shield remover from being reinserted into the cassette.

26. The cassette of claim 25, wherein the shield remover comprises a spring-biased tab, the tab disposed within an aperture defined in a wall of the housing to prevent removal of the shield remover from the cassette.

27. The cassette of claim 25, further comprising a syringe disposed in the sleeve, wherein the syringe includes a barrel and an injection needle.

28. The cassette of claim 27, further comprising a therapeutic product in the syringe, wherein the therapeutic product is Epogen®

, Aranesp®

, Enbrel®

, Neulasta®

, Neupogen®

, Nplate®

, Vectibix®

, Sensipar®

, Xgeva® and

Prolia®

, an antibody to IL-17 Receptor A, an antagonist of angiopoietin-2, a TNF blocker or inhibitor, etanercept, adalimumab, certolizumab, golimumab, or infliximab.

29. The cassette of claim 28, wherein the therapeutic product is etanercept.

30. An apparatus for injection of a therapeutic product, the apparatus comprising:

an autoinjector; and

a single-use cassette for use with the injector, the cassette comprising;

a housing;

a sleeve disposed in the housing and movable between first and second positions;

a syringe disposed in the sleeve; and

a shield remover extending through an opening in a proximal end of the housing for removing a needle shield from the syringe, the shield remover comprising an elongated body having a proximal end and a distal end, the distal end comprising at least one flexible tongue that expands outwardly when the shield remover is removed from the cassette to prevent the shield remover from being reinserted into the cassette.

31. The apparatus of claim 30, wherein the shield remover comprises a spring-biased tab, the tab disposed within an aperture defined in a wall of the housing to prevent removal of the shield remover from the cassette.

32. The apparatus of claim 30, wherein the autoinjector comprises a pin for pushing the tab out of the aperture defined in the wall of the housing when the cassette is placed in the injector to thereby allow the shield remover to be removed from the cassette.

33. The apparatus of claim 30, further comprising a therapeutic product in the syringe, wherein the therapeutic product is Epogen®

, Aranesp®

, Enbrel®

, Neulasta®

, Neupogen®

, Nplate®

, Vectibix®

, Sensipar®

, Xgeva®

, Prolia®

, an antibody to IL-17 Receptor A, an antagonist to angiopoietin-2, a TNF blocker or inhibitor, etanercept, adalimumab, certolizumab, golimumab, or infliximab.

34. The apparatus of claim 33, wherein the therapeutic product is etanercept.