Drug cassette, autoinjector, and autoinjector system

• US 10,092,703 B2
• Filed: 03/14/2014
• Issued: 10/09/2018
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Amgen Inc.
• Original Assignee: Amgen Inc.
• Inventors: Mounce, R. Paul, Judd, Clinton
• Primary Examiner(s): FLICK, JASON E
• Application Number:
  US14/777,259
• Publication Number:
  US 20160022914A1
• Time in Patent Office: 1,670 Days
• Field of Search: 604189
• 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 2005/208 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 2005/3142 Modular constructions, e.g. supplied in separate pieces to be assembled by end-user
• CPC Class Codes: A61M 2005/3247 Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
• CPC Class Codes: A61M 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/192 Avoiding coring, e.g. preventing formation of particles during puncture
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/586 Ergonomic details therefor, e.g. specific ergonomics for left or right-handed users
• CPC Class Codes: A61M 2205/60 with identification means
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6027 Electric-conductive bridges closing detection circuits, with or without identifying elements, e.g. resistances, zener-diodes
• CPC Class Codes: A61M 2205/6036 characterised by physical shape, e.g. array of activating switches
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 2205/6072 Bar codes
• CPC Class Codes: A61M 2205/6081 Colour codes
• 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 5/24 : 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 5/3134 : characterised by constructional features of the distal end, i.e. end closest to the tip of the needle cannula
• 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 5/3271 : with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position
• CPC Class Codes: A61M 5/5086 : for indicating if defective, used, tampered with or unsterile
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

A cassette for use with an injector has a housing, and a cassette identification arrangement (cassette ID) defining a code containing information about the cassette that is detectable and decipherable by an injector. The cassette may further have an integrated cassette syringe movably disposed within the housing, for holding a drug, and a locking arrangement for interlocking the integrated cassette syringe with the housing. The cassette may further have an aperture in the housing, and a cassette cap for removing a needle shield of the integrated cassette syringe. The cassette may have an anti-bending structure to prevent bending or flexing of the cassette cap. The injector may have a processor for controlling operational parameters of the injector and a detector communicatively coupled with the processor for detecting and communicating the cassette ID to the microprocessor to decipher the code defined therein.

Claims

1. A cassette for an injector, the cassette comprising:

a housing; and

a body member having a fluid chamber for containing a drug and an injection needle in fluid communication with the fluid chamber, the body member moveable in the housing between a proximal position and a distal position;

a locking arrangement for interlocking the body member with the housing, the locking arrangement comprising a spring-biased member associated with one of the housing and the body member, and a fixed member associated with the other one of the housing and the body member for interlocking with the spring-biased member;

wherein the locking arrangement further comprises a cam for unlocking the spring-biased and fixed members;

wherein the cam is actuated by the injector during a needle-insertion cycle of the injector.

2. The cassette according to claim 1 wherein the body member has an open distal end for allowing the injector to interface with a plunger-stopper disposed in the fluid chamber.

3. The cassette according to claim 1, wherein the body member has a drive post for allowing the injector to interface with the body member.

4. The cassette according to claim 1, wherein the cam is associated with the spring-biased member.

5. The cassette according to claim 1, wherein the spring-biased member comprises at least one locking foot and the fixed member comprises at least one slot, the at least one locking foot engaging the at least one slot in a locked position, to interlock the body member with the housing.

6. The cassette according to claim 5, wherein the at least one locking foot is disposed on a hand member.

7. The cassette according to claim 6, wherein the hand member is connected to the one of the housing and the body member by at least one flexible arm member, the at least one flexible arm member biasing the hand member.

8. The cassette according to claim 7, wherein the at least one flexible arm member biases the hand member in an unlocked position where the at least one locking foot is disengaged from the at least one slot.

9. The cassette according to claim 7, wherein the at least one arm member biases the hand member in the locked position where the at least one locking foot is engaged with the at least one slot.

10. The cassette according to claim 6, wherein the cam is disposed on the hand member.

11. The cassette according to claim 5, wherein the at least one locking foot and the at least one slot have angled surfaces which engage one another if the at least one locking foot is engaged with the at least one slot, to facilitate self-locking or self-unlocking thereof, depending upon the angle of the angled surfaces.

12. The cassette according to claim 1, wherein the locking arrangement further comprises a second cam for preventing the spring biased member from interfering with the assembly of the body member to the housing.

13. The cassette according to claim 12, wherein the second cam is disposed on a hand member connected to the one of the housing and the body member.

14. The cassette according to claim 13, wherein the second cam extends forward of a leading edge of the hand member.

15. The cassette according to claim 1, further comprising a latch mechanism comprising a first member associated with the housing and a second member associated with the body member.

16. The cassette according to claim 1, further comprising:

a needle shield disposed over the injection needle;

a cassette cap for removing the needle shield, the cassette cap comprising first and second body portions, the first body portion engaging the needle shield, the first body portion extending through an aperture in the housing and defining an end that can be gripped to withdraw the cassette cap from the housing to remove the needle shield, the second body portion defining a key; and

an anti-bending structure for preventing bending or flexing of the cassette cap, the cassette cap having at least a first member associated with the key and the housing having at least a second member for interacting with the first member.

17. The cassette according to claim 16, wherein the first member comprises a first pair of tabs.

18. The cassette according to claim 17, wherein the first pair of tabs are disposed on side walls of the key.

19. The cassette according to claim 17, wherein the first member further comprises a second pair of tabs spaced from the first pair of tabs.

20. The cassette according to claim 19, wherein the second pair of tabs are disposed on side walls of the key.

21. The cassette according to claim 20, wherein the second pair of tabs extend from outer surfaces of the side walls.

22. The cassette according to claim 19, wherein the first pair of tabs are disposed adjacent a first end of the key and the second pair of tabs are disposed adjacent to a second end of the key.

23. The cassette according to claim 16, wherein the second member comprises a pair of ribs.

24. The cassette according to claim 23, wherein the pair of ribs are disposed on side walls of the housing.

25. The cassette according to claim 24, wherein the first member comprises a first pair of tabs and upper surfaces of the first pair of tabs engage lower surfaces of the pair of ribs.

26. The cassette according to claim 24, wherein the pair of ribs extend from interior surfaces of the side walls.

27. The cassette according to claim 16, wherein the end of the first body portion includes a gripping flange.

28. The cassette according to claim 1, further comprising a cassette identification arrangement (cassette ID) defining a code containing information about the cassette, the code being detectable and decipherable by the injector, the cassette ID disposed on the housing, embedded within the housing, provided on or in a separate structure contained within the housing, or any combination thereof.

29. The cassette according to claim 28, wherein the cassette ID comprises a contact system that requires contact between the cassette ID and the injector, a non-contact system that requires no contact between the cassette ID and the injector, or any combination thereof.

30. The cassette according to claim 29, wherein the contact system comprises one or more tabs, one or more indentations, one or more electrically conductive strips, or any combination thereof, for contacting one or more sensing elements of a detector of the injector when the cassette is placed in or on the injector.

31. The cassette according to claim 30, wherein the code is at least partially determined by the absence of one or more of the one or more tabs, indentations, electrically conductive strips, or any combination thereof.

32. The cassette according to claim 30, wherein the one or more tabs, indentations, electrically conductive strips, or any combination thereof are provided at various housing positions, the code at least partially determined by the various housing positions of the one or more tabs, indentations, electrically conductive strips, or any combination thereof.

33. The cassette according to claim 30, wherein the number of the one or more tabs, indentations, electrically conductive strips, or combination thereof, at least partially determining the code.

34. The cassette according to claim 30, wherein each of the one or more electrically conductive strips defines a straight or tortuous path, the code at least partially determined by the path of each of the one or more electrically conductive strips.

35. The cassette according to claim 30, wherein each of the one or more tabs has a length selected from two or more different lengths, the code at least partially determined by the length of the one or more tabs.

36. The cassette according to claim 30, wherein each of the one or more indentations has a depth selected from two or more different depths, the code at least partially determined by the depth of the one or more indentations.

37. The cassette according to claim 29, wherein the non-contact system comprises a device for emitting a radio-frequency (RF) electromagnetic field (EMF), a device for emitting a magnetic field (MF), a device for emitting a machine-readable optical representation of data (ORD), or any combination thereof, the RF EMF, MF, ORD, or any combination thereof being sensed by a detector of the injector when the cassette is placed in or on the injector, the code at least partially determined by the RF EMF, MF, ORD, or any combination thereof.

38. The cassette according to claim 1, wherein the fluid chamber of the body member is filled with a drug.

39. The cassette according to claim 28, wherein the information comprises information that identifies the type of cassette, identifies the content of the cassette, identifies whether the cassette is an OEM cassette, identifies manufacturing data about the cassette, or any combination thereof, wherein the information that identifies the content of the cassette comprises at least one of the quantity of drug in the body member or drug characteristics, and wherein the information allows the injector to adjust or select its operational parameters or select one or a plurality of operational programs.

40. The cassette according to claim 38, wherein the drug comprises a therapeutic product and wherein the therapeutic product comprises one of epoetin alfa, darbepoetin alfa, etanercept, TNF-receptor/Fc fusion protein, peqylated filgastrim, peqylated G-CSF, peqylated hu-met-G-CSF, filgrastim, G-CSF, hu-met-G-CSF, romiplostim, panitumumab, cinacalcet, denosamab, AMG 162, an antibody to IL-17 Receptor A, an antagonist of angiopoietin-2, a TNF blocker, and a TNF inhibitor.

41. The cassette according to claim 38, wherein the drug comprises a therapeutic product and wherein the therapeutic product has a viscosity of about 19 centipoise, at room temperature.

42. The cassette according to claim 38, wherein the drug comprises a therapeutic product and wherein the therapeutic product has a viscosity ranging between about 1 centipoise and about 320 centipoise, at room temperature.

43. A cassette for an injector, the cassette comprising:

a housing;

a body member having a fluid chamber for containing a drug and an injection needle in fluid communication with the chamber, the body member moveable in the housing between a proximal position and a distal position; and

a locking arrangement for interlocking the body member with the housing, the locking arrangement comprising a spring-biased member associated with one of the housing and the body member, and a fixed member associated with the other one of the housing and the body member for interlocking with the spring-biased member, wherein the locking arrangement further comprises;

a cam for unlocking the spring-biased and fixed members; and

a second cam for preventing the spring biased member from interfering with the assembly of the body member to the housing, wherein the second cam is disposed on a hand member connected to the one of the housing and the body member.

44. A cassette for an injector, the cassette comprising:

a housing;

a body member having a fluid chamber for containing a drug and an injection needle in fluid communication with the fluid chamber, the body member moveable in the housing between a proximal position and a distal position; and

a cassette identification arrangement (cassette ID) defining a code containing information about the cassette, the code being detectable and decipherable by the injector, the cassette ID disposed on the housing, embedded within the housing, provided on or in a separate structure contained within the housing, or any combination thereof;

wherein the cassette ID comprises a contact system that requires contact between the cassette ID and the injector, the contact system comprises one or more electrically conductive strips for contacting one or more sensing elements of a detector of the injector when the cassette is placed in or on the injector, and each of the one or more electrically conductive strips defines a straight or tortuous path, the code at least partially determined by the path of each of the one or more electrically conductive strips.