Claims for Patent: 9,443,445

Summary for Patent: 9,443,445

Title:	Automatic injection training device
Abstract:	Exemplary embodiments of the present disclosure provide reusable training automatic injection training devices, and components thereof, to simulate and/or mimic an operation of an actual automatic injection device. Exemplary embodiments of the training device can provide audible instructions, which can be in different languages, output from circuitry associated with the training device. Exemplary embodiment of the training device can be a self-contained and portable device that mimics a shape, size, and function of an actual automatic injection device without including a needle or any drug on board. Exemplary embodiments can be implemented to train a user on an operation and/or usage of an actual automatic injection device using embodiments of the automatic injection training devices so that a user can practice an autoinjection without injecting a therapeutic agent, such as a liquid drug, into a recipient.
Inventor(s):	Laurusonis; Linas P. (Gurnee, IL), Anderson; Philip D. (Libertyville, IL), Widman; Matthew M. (Gurnee, IL), McLeroy; Timothy D. (Bristol, WI)
Assignee:	AbbVie Inc. (North Chicago, IL)
Application Number:	13/782,797
Patent Claims:	1. An automatic injection training device to simulate an automatic injection, the training device comprising: an elongate housing extending along a longitudinal axis, the housing having a proximal end and a distal end, the proximal end including an actuation member; a movable member disposed within the housing, the movable member being movable with respect to the housing; a firing assembly disposed within the housing to actuate the movable member to simulate an automatic injection in response to an activation of the actuation member; circuitry disposed within the housing to control an output of audio to train a user on an operational sequence of an actual automatic injection device using the training device; the circuitry comprising: audio circuitry to output the audio; a nonvolatile storage device to store the audio output by the audio circuitry; a programmable processing device configured to control the output of the audio; and one or more sensors to sense a condition of the training device to provide an input to the programmable processing device to control an operation of the circuitry; and an end cap configured to reset the training device after an actuation of the movable member. 2. The training device of claim 1, wherein the movable member comprises a sleeve. 3. The training device of claim 2, wherein the sleeve is movable with respect to the housing between a retracted position and a protracted position and comprises a generally tubular body extending along the longitudinal axis, the sleeve being biased in the retracted position by a second biasing member. 4. The training device of claim 3, wherein the sleeve is urged from the retracted position to the protracted position in response to an actuation of the actuation member. 5. The training device of claim 1, wherein the movable member comprises a plunger. 6. The training device of claim 5, wherein the plunger is movable with respect to the housing between a retracted position and a protracted position and comprises a main body portion and a retaining member extending along the longitudinal axis. 7. The training device of claim 6, wherein the firing assembly further comprises: a plunger actuation holder to selectively retain the plunger in the retracted position; and a biasing member configured to bias the plunger to the protracted position. 8. The training device of claim 7, wherein an actuation of the actuation member releases the plunger from the plunger actuation holder and the biasing member urges the plunger along the longitudinal axis towards the distal end of the housing from the retracted position to the protracted position. 9. The training device of claim 1, wherein the movable member comprises a plunger and a sleeve, the sleeve surrounding at least a portion of the plunger, the plunger being movable with respect to at least one of the sleeve and the housing. 10. The training device of claim 9, wherein the sleeve and the plunger are movable with respect to each other, and each are movable with respect to the housing. 11. The training device of claim 1, wherein the circuitry includes a power source. 12. The training device of claim 1, further comprising a control interface disposed with respect to the housing to provide an interface between the user and the circuitry, the control interface including one or more controls to control an operation of the circuitry. 13. The training device of claim 1, wherein the circuitry further comprises control interface circuitry in electrical communication with the programmable processing device to control an operation of the programmable processing device. 14. The training device of claim 13, wherein the control interface circuitry comprises a control operable by the user to provide an input to the programmable processing device to control an operation of the circuitry. 15. The training device of claim 14, wherein the control includes at least one of an output language selector to select an output language of the audio and an audio playback control to start the output of the audio. 16. The training device of claim 1, further comprising a visual indicator corresponding to an operation of the training device. 17. The training device of claim 16, wherein the visual indicator is a light source. 18. The training device of claim 17, wherein the light source is a light emitting diode. 19. The training device of claim 17, wherein the light source indicates a status of an operation of the training device. 20. The training device of claim 17, wherein the light source illuminates a portion of the housing to correspond to the output of the audio. 21. The training device of claim 16, wherein the indicator is disposed with respect to the movable member. 22. The training device of claim 21, wherein the indicator is a solid color graphic. 23. The training device of claim 1, wherein the circuit is configurable to output the audio in different languages. 24. The training device of claim 1, wherein the circuitry is configured to operate in at least one of a first mode, in which the audio is output by the circuitry without determining whether an operation of the training device corresponds to the audio, and a second mode, in which the audio is output by the circuitry at least in part in response to a determination that the operation of the training device corresponds to the audio being output. 25. The training device of claim 1, wherein the end cap is disposable with respect to the distal end of the training device. 26. The training device of claim 25, wherein the end cap comprises a resetting member configured to extend through an opening in the distal end of the housing to urge the movable member from a protracted position to a retracted position. 27. The training device of claim 1, wherein the circuitry is configured to be in electrical communication with another device that is remote to the training device. 28. The training device of claim 27, wherein the other device comprises a computing device. 29. The training device of claim 1, wherein the circuitry automatically pauses the output of the audio and restarts the output of the audio in response to an actuation of a playback button. 30. The training device of claim 1, wherein the circuitry is configured to select between continuous output of the audio and automatically pausing the output of the audio. 31. The training device of claim 1, wherein the circuitry includes at least one sensor to monitor an operation of the training device, the circuitry being configured to output at least one of a corrective instruction when the sensor detects that the user incorrectly followed an instruction included in the output of the audio, an acknowledgment when the sensor detects that the user correctly followed an instruction included in the output of the audio, repeat an instruction included in the output of the audio when the sensor detects that the user incorrectly followed an instruction included in the output of the audio, automatically pause the output of the audio in response to an input from the sensor. 32. The training device of claim 1, wherein the circuitry is programmed to output instructions to a user and to confirm that that instruction was completed correctly before advancing the output to a subsequent instruction. 33. The training device of claim 1, wherein the circuitry alerts the user when the user attempts to deviate from the recommended sequence. 34. A method for training a user on an operational sequence of an actual automatic injection device using an automatic injection training device comprising: receiving an input selection from a user via a control interface of an automatic injection training device, the control interface controlling an operation of circuitry included in the automatic injection training device; sensing a condition of the training device via one or more sensors; outputting audio via the circuitry based on the condition of the training device to train the user on an operational sequence of an actual automatic injection device using the automatic injection training device in response to the input selection; actuating a firing assembly disposed within a housing of the training device to simulate an automatic injection in response to a depression of a firing button disposed at a proximal end of the housing by the user; urging the plunger disposed within the housing from a retracted set position to a protracted triggered position in response to actuation of the firing assembly; displaying an indicator to the user to indicate a completion of the automatic injection; and resetting the plunger to the retracted position to facilitate reuse of the automatic injection training device. 35. The method of claim 34, wherein resetting the plunger comprises receiving an end cap on the distal end of the training device, the end cap having a resetting member configured to extend into the training device and to engage the plunger to urge the plunger from the protracted position to the retracted position. 36. The method of claim 34, further comprising: receiving a second input selection from the user; and performing at least one of stopping an output of the audio in response to the second input selection and restarting the output of the audio to repeat a previously output portion of the audio. 37. The method of claim 34, further comprising: receiving a language selection from the user to change an output language of the audio; and outputting the audio in the output language selected by the user. 38. The method of claim 34, further comprising: receiving an operation mode selection from the user, the operation mode selected being at least one of a first mode, in which the audio is output by the circuitry without determining whether an operation of the training device corresponds to the audio, and a second mode, in which the audio is output by the circuitry in response to a determination that the operation of the training device corresponds to the audio; and operating the circuitry according to the operation mode selected. 39. The method of claim 34, further comprising: releasably retaining a plunger in a retracted set position; biasing the plunger to urge the actuation to the protracted triggered position upon actuation of the firing assembly; releasing the plunger in response to the depression of the firing button; and urging the plunger from the retracted set position to the protracted triggered position by the biasing member to simulate an injection. 40. A non-transitory computer-readable medium embedded in an automatic injection training device, the computer readable medium storing instructions executable by a programmable processing device to cause the programmable processing device to: receive an input selection from a user via a control interface of an automatic injection training device, the control interface controlling an operation of circuitry included in the automatic injection training device; sense a condition of the training device via one or more sensors; output audio via a speaker in the automatic injection training device based on the condition of the training device to train a user on an operational sequence of an actual automatic injection device using the automatic injection training device in response to the input selection; instruct the user to depress a firing button disposed at a proximal end of the housing by the user to actuate a firing assembly disposed within a housing of the training device to simulate an automatic injection; and instruct the user to replace the end cap on the training device to reset the training device. 41. A kit comprising: an automatic injection training device to simulate an automatic injection; circuitry disposed within the automatic injection training device programmed to output an audio script to train a user on an operational sequence of an actual automatic injection device; the circuitry comprising: audio circuitry to output the audio script; a nonvolatile storage device to store the audio output by the audio circuitry a programmable processing device configured to control the output of the audio; and one or more sensors to sense a condition of the training device to provide an input to the programmable processing device to control an operation of the circuitry; an end cap configured to reset the training device; and informational material, the informational material including information corresponding to at least one of a description of the automatic injection training device, a description of an actual automatic injection device corresponding to the training device, information to train the user on a use of the automatic injection training device, and information to train the user on a use of the actual automatic injection device. 42. The kit of claim 41, wherein the automatic injection training device comprises: circuitry configured to train the user on an operational sequence of the actual automatic injection device using the automatic injection training device; and a control interface including controls selectable by the user to control an operation of the circuitry, wherein the circuitry is disposed within the automatic injection training device and the control interface is incorporated into a housing of the automatic injection training device. 43. The kit of claim 41, further comprising a container for holding the automatic injection training device and the at least one printed document. 44. The kit of claim 41, wherein the automatic injection training device comprises: an elongate housing extending along a longitudinal axis, the housing having a proximal end and a distal end, the proximal end including an actuation member; a movable member disposed within the housing, the movable member being movable with respect to the housing; and a firing assembly disposed within the housing to actuate the movable member to simulate an automatic injection in response to an actuation of the actuation member. 45. The kit of claim 41, wherein the informational material includes at least one of a digital versatile disc, a CD-ROM, and a flash drive storing at least one of audio information and video information. 46. The kit of claim 41, wherein the informational material includes at least one printed document. 47. A training device comprising: circuitry to control an output of audio to train a user on an operational sequence of an actual automatic injection device using the training device; the circuitry comprising: audio circuitry to output the audio script; a nonvolatile storage device to store the audio output by the audio circuitry a programmable processing device configured to control the output of the audio; and one or more sensors to sense a condition of the training device to provide an input to the programmable processing device to control an operation of the circuitry; and a first activation button to activate a firing assembly and a syringe carrier devoid of a therapeutic agent; and a second activation button to output audio from the training device. 48. The training device of claim 47, further comprising an end cap configured to reset the training device. 49. A method of training a user on an automatic injection of a TNF.alpha. inhibitor using an automatic injection training device devoid of the TNF.alpha. inhibitor, the automatic injection training device corresponding to an actual automatic injection device including the TNF.alpha. inhibitor, the method comprising: receiving an input selection from a user via a control interface of the automatic injection training device, the control interface controlling an operation of circuitry included in the automatic injection training device; sensing a condition of the training device via one or more sensors; outputting audio via the circuitry based on the condition of the training device to train the user on an operational sequence of an automatic injection of the TNF.alpha. inhibitor in response to the input selection; actuating a firing assembly disposed within a housing of the training device to simulate an automatic injection of the TNF.alpha. inhibitor in response to a depression of a firing button disposed at a proximal end of the housing by the user; displaying an indicator to the user to indicate a completion of a simulation of the automatic injection of the TNF.alpha. inhibitor; and resetting the training device using an end cap after actuation of the firing assembly. 50. The method of claim 49, wherein the TNF.alpha. inhibitor is adalimumab.

Details for Patent 9,443,445

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002		2032-03-02
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008		2032-03-02
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013		2032-03-02
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	09/23/2014		2032-03-02
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	11/23/2015		2032-03-02
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	03/09/2016		2032-03-02