DRUG CASSETTE, AUTOINJECTOR, AND AUTOINJECTOR SYSTEM

• US 20160120751A1
• Filed: 03/14/2014
• Published: 05/05/2016
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Amgen Inc.
• Original Assignee: Amgen Inc.
• Inventors: Mounce, R. Paul, Judd, Clinton, Krishna, Suhas, Ganzitti, Gabriele, Johnston, Neal D., Johnston, Gordon, Sardo, Giorgio, Yeh, Hong Jun
• Granted Patent: US 10,492,990 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61J 1/18 Arrangements for indicating condition of container contents, e.g. sterile condition
• CPC Class Codes: A61J 2205/60 using magnetic or electronic identifications, e.g. chips, RFID, electronic tags
• 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 2005/2414 from the side
• CPC Class Codes: A61M 2005/2481 comprising means for biasing the ampoule out of the ampoule holder
• 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 2205/14 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 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/581 by audible feedback
• 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 2205/6063 Optical 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 5/3202 : 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 5/427 : Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates
• CPC Class Codes: A61M 5/46 : having means for controlling depth of insertion
• CPC Class Codes: A61M 5/482 : Varying injection pressure, e.g. by varying speed of injection
• CPC Class Codes: A61P 19/00 : Drugs for skeletal disorders
• CPC Class Codes: A61P 19/02 : for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 19/10 : for osteoporosis
• 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 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 35/04 : specific for metastasis
• CPC Class Codes: A61P 37/04 : Immunostimulants
• CPC Class Codes: A61P 5/18 : of the parathyroid hormones
• CPC Class Codes: A61P 7/06 : Antianaemics
• CPC Class Codes: G09B 23/285 : for injections, endoscopy, bronchoscopy, sigmoidscopy, insertion of contraceptive devices or enemas

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 a sleeve movably disposed within the housing, for holding a drug container, and a locking arrangement for interlocking the sleeve with the housing. The cassette may further have an aperture in the housing, and a cassette cap for removing a needle shield of the drug container. 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. Also, a method of injecting a drug into a patient with an injector, wherein the sequence of actions performed by the user are controlled. Still further, a method of treating a patient in need thereof wherein a cassette containing a drug is provided and administered to the patient using an injector.

Claims

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

a housing; 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.

2. The cassette according to claim 1, 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.

3. The cassette according to claim 2, 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.

4. The cassette according to claim 3, 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.

5. The cassette according to claim 3, 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.

6. The cassette according to claim 3, wherein the number of the one or more tabs, indentations, electrically conductive strips, or combination thereof, at least partially determines the code.

7. The cassette according to claim 3, wherein each of the one or more electrically conductive strips forms a straight or tortuous path, the code at least partially determined by the path of each of the one or more electrically conductive strips.

8. The cassette according to claim 3, 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.

9. The cassette according to claim 3, 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.

10. The cassette according to claim 2, wherein the non-contact system comprises a device for emitting a radio-frequency (RF), a device for emitting an 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.

13. The cassette according to claim 1, further comprising a container filled for treatment or prefilled with a drug.

15. The cassette according to claim 1, 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 the quantity of drug in the container and/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.

21. The cassette according to claim 13, wherein the drug comprises a therapeutic product and wherein the therapeutic product comprises one of Epogen®

, Aranesp®

, Enbrel®

Neulasta®

, Neupogen®

, Nplate®

, Vectibix®

, Sensipar®

, Xgeva®

, Prolia®

, an antibody to IL-17 Receptor A, an antagonist of angiopoietin-2, a TNF blocker, and a TNF inhibitor.

27. The cassette according to claim 13, wherein the drug comprises a therapeutic product and wherein the therapeutic product has a viscosity of about 19 centipoise at room temperature.

28. The cassette according to claim 13, 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.

42. An injector comprising:

a processor for controlling operational parameters of the injector;

a surface for supporting a cassette having a cassette identification arrangement (cassette ID), the cassette ID defining a code that contains information about the cassette; and

a detector communicatively coupled with the processor, the detector for detecting and communicating the cassette ID to the microprocessor to decipher the code defined therein in combination with the cassette according to claim 1.

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

a housing;

a sleeve movably disposed within the housing, the sleeve for directly or indirectly holding a drug container;

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

44. The cassette according to claim 43, wherein the locking arrangement further comprises a cam for unlocking the spring-bias and fixed members.

45. The cassette according to claim 44, wherein the cam is associated with the spring-biased member.

46. The cassette according to claim 43, 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 sleeve with the housing.

47. The cassette according to claim 46, wherein the at least one locking foot is disposed on a hand member.

48. The cassette according to claim 47, wherein the hand member is connected to the one of the housing and the sleeve by at least one flexible arm member, the at least one arm member biasing the hand member.

49. The cassette according to claim 48, wherein the at least one 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.

50. The cassette according to claim 48, 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.

51. The cassette according to claim 48, wherein the cam is disposed on the hand member.

52. The cassette according to claim 44, wherein the cam is actuated by the injector during a needle-insertion cycle of the injector.

53. The cassette according to claim 44, 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 surfaces.

54. The cassette according to claim 43, wherein the locking arrangement further comprises a second cam for preventing the spring biased member from interfering with the assembly of the sleeve to the housing.

55. The cassette according to claim 54, wherein the second cam is disposed on the hand member.

56. The cassette according to claim 55, wherein the second cam extends forward of a leading edge of the hand member.

57. The cassette according to claim 43, further comprising a latch mechanism comprising a first member associated with the housing and a second member associated with the sleeve.

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

a housing having an aperture;

a drug container disposed in the housing, the drug container having an injection needle and a needle shield disposed over the injection needle;

a cassette cap for removing the needle shield, the cassette cap comprising a generally cylindrical body portion and a key portion disposed adjacent to the cylindrical body portion, the cylindrical body portion engaging the needle shield, the cylindrical body portion having a portion extending through the aperture in the housing that can be gripped to withdraw the cassette cap from the housing to remove the needle shield; and

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

77. The cassette according to claim 76, wherein the first member comprises a first pair of tabs.

78. The cassette according to claim 77, wherein the first pair of tabs are disposed on side walls of the key portion.

79. The cassette according to claim 77, wherein the first member further comprises a second pair of tabs spaced from the first pair of tabs.

80. The cassette according to claim 79, wherein the second pair of tabs are disposed on side walls of the key portion.

81. The cassette according to claim 80, wherein the tabs extend from outer surfaces of the side walls.

82. The cassette according to claim 79, wherein the first pair of tabs are disposed adjacent a first end of the key portion and the second pair of tabs are disposed adjacent to a second end of the key portion.

83. The cassette according to claim 76, wherein the second member comprises a pair of ribs.

84. The cassette according to claim 83, wherein the ribs are disposed on side walls of the housing.

85. The cassette according to claim 84, wherein surfaces of the tabs engage surfaces of the ribs.

86. The cassette according to claim 84, wherein the ribs extend from interior surfaces of the side walls.

87. The cassette according to claim 76, wherein the portion of the cylindrical body extending through the aperture in the housing has a gripping flange.

11-12. -12. (canceled)

14. (canceled)

16-20. -20. (canceled)

22-26. -26. (canceled)

29-34. -34. (canceled)

35. An injector comprising:

a processor for controlling operational parameters of the injector;

a surface for supporting a cassette having a cassette identification arrangement (cassette ID), the cassette ID defining a code that contains information about the cassette; and

a detector communicatively coupled with the processor, the detector for detecting and communicating the cassette ID to the microprocessor to decipher the code defined therein.

36. The injector according to claim 35, wherein the detector comprises a contact system that requires contact between the cassette ID and the detector, a non-contact system that requires no contact between the cassette ID and the detector, or any combination thereof.

37. The injector according to claim 36, wherein the contact system comprises one or more switches, two or more pogo-pin connectors, or any combination thereof.

38. The injector according to claim 37, wherein the one or switches can be switched into an off state and an on state.

39. The injector according to claim 37, wherein the one or more switches can be switched into an off state, a first on state and at least a second on state.

40. The injector according to claim 37, wherein simultaneous actuation of at least two of the two more pogo-pin connectors closes a circuit.

41. The injector according to claim 36, wherein the non-contact system comprises a device for receiving a radio-frequency (RF) electromagnetic field (EMF), a device for receiving a magnetic field (MF), a device for reading an optical representation of data, or any combination thereof.

58. (canceled)

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

a housing;

a sleeve movably disposed within the housing, the sleeve for directly or indirectly holding a drug container;

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

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;

a drug container disposed in the sleeve, the drug container having an injection needle and a needle shield disposed over the injection needle;

a cassette cap for removing the needle shield, the cassette cap comprising a generally cylindrical body portion and a key portion disposed adjacent to the cylindrical body portion, the cylindrical body portion engaging the needle shield, the cylindrical body portion having a portion extending through the aperture in the housing that can be gripped to withdraw the cassette cap from the housing to remove the needle shield; 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 portion and the housing having at least a second member for interacting with the first member.

60-75. -75. (canceled)

88-117. -117. (canceled)