Devices, systems and methods for medicament delivery

• US 9,259,539 B2
• Filed: 08/27/2014
• Issued: 02/16/2016
• Est. Priority Date: 02/01/2005
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Kaleo, Inc.
• Inventors: Edwards, Eric S., Edwards, Evan T., Meyers, Paul F., Weinzierl, David A., Licata, Mark J.
• Primary Examiner(s): SCHMIDT, EMILY LOUISE
• Application Number:
  US14/470,165
• Publication Number:
  US 20140371714A1
• Time in Patent Office: 538 Days
• Field of Search: 604/131, 604134-137, 604/189, 604/890, 604/1, 128/200.14, 128/200.23
• US Class Current: 1/1
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• 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 2205/50 with microprocessors or computers
• 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 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/587 Lighting arrangements
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 35/00 Devices for applying media, e.g. remedies, on the human body devices for handling toiletry or cosmetic substances A45D; absorbent pads, e.g. swabs, A61F13/15
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/19 having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491
• 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 5/2046 Media being expelled from injector by gas generation, e.g. explosive charge
• CPC Class Codes: A61M 5/2053 Media being expelled from injector by pressurised fluid or vacuum for infusion A61M5/145, A61M5/155
• 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 5/3234 Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
• 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 5/3287 : Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence
• CPC Class Codes: A61M 5/5086 : for indicating if defective, used, tampered with or unsterile
• CPC Class Codes: G16H 20/13 : delivered from dispensers
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass

Abstract

An apparatus includes a label configured to be coupled to a medicament delivery device. The label includes a first surface and a second surface. The first surface is configured to be coupled to an outer surface of the medicament delivery device. The second surface includes a textual indicia. The label further includes an electronic circuit system configured to output an electronic signal.

Claims

1. A method, comprising:

receiving, in response to an actuator of a medicament delivery device moving relative to a housing of the medicament delivery device, a first electronic signal, the medicament delivery device configured to move a needle from a retracted position within the housing to a delivery position outside of the housing and to deliver a medicament via the needle in response to the actuator activating an energy storage member, the actuator activating the energy storage member when the actuator is moved in a first direction from a first actuator position to a second actuator position;

sending, in response to receiving the first electronic signal, a second electronic signal to a speaker to cause the speaker to emit an audible instruction associated with a use of the medicament delivery device;

engaging a lock portion of the actuator with a corresponding portion of the housing to limit movement of the actuator from the second actuator position towards the first actuator position after activation of the energy storage member; and

moving, independent from movement of the housing and after the delivery of the medicament via the needle, the needle in a proximal direction from the delivery position outside of the housing towards the retracted position within the housing.

2. The method of claim 1, wherein the audible instruction is a recorded speech output confirming the delivery of the medicament and prompting a user to seek medical attention.

3. The method of claim 1, wherein the audible instruction is a first recorded speech output including a post-use instruction, the method further comprising:

receiving, in response to a needle sheath being removed from a location inside of the housing and about the needle, a third electronic signal before receiving the first electronic signal; and

sending, in response to receiving the third electronic signal, a fourth electronic signal to the speaker to cause the speaker to emit a second recorded speech output including a pre-use instruction.

4. The method of claim 1, wherein the audible instruction is a first recorded speech output including a post-use instruction and the housing of the medicament delivery device defines an opening through which at least a portion of the needle is disposed when the needle is in the delivery position outside of the housing, the method further comprising:

receiving a third electronic signal before the receiving the first electronic signal, the third electronic signal received in response to a moveable member moving relative to the housing from a first position to a second position, the moveable member configured to cover the opening and limit movement of actuator relative to the housing when the moveable member is in the first position; and

sending, in response to receiving the third electronic signal, a fourth electronic signal to the speaker to cause the speaker to emit a second recorded speech output providing an instruction identifying the actuator of the medicament delivery device.

5. The method of claim 4, wherein the second recorded speech output includes an instruction for moving the actuator, the method further comprising:

sending, in response to receiving the third electronic signal, a fifth electronic signal to a light output device to cause the light output device to produce a visual indication associated with the actuator.

6. The method of claim 1, wherein the first electronic signal is received in response to a protrusion of the actuator moving a switch.

7. The method of claim 1, wherein:

the first electronic signal is received in response to a first portion of the actuator moving a switch; and

the energy storage member is a non-electronic energy storage member, a second portion of the actuator is configured to actuate the non-electronic energy storage member.

8. The method of claim 1, wherein the audible instruction is a first recorded speech output including a post-use instruction, the method further comprising:

receiving from a temperature sensor disposed within the housing a third electronic signal before the receiving the first electronic signal; and

sending, in response to receiving the third electronic signal, a fourth electronic signal to the speaker to cause the speaker to emit a second recorded speech output providing an instruction that the medicament is below a temperature threshold for delivery.

9. The method of claim 1, further comprising:

moving, in response to delivery of the medicament via the needle, a status indicator within the housing such that the status indicator is visible through an opening defined by the housing.

10. The method of claim 1, wherein the medicament is epinephrine.

11. The method of claim 1, wherein the energy storage member is a container configured to produce a pressurized gas when the container is activated.

15. The non-transitory processor readable medium of claim 10, wherein the instruction is a first instruction and the recorded speech output is a first recorded speech output, the code further comprising code to cause the processor to:

receive from a temperature sensor disposed within the housing a third electronic signal before the receiving the first electronic signal; and

send, in response to receiving the third electronic signal, a fourth electronic signal to the speaker to cause the speaker to emit a second recorded speech output providing an instruction that the medicament is below a temperature threshold for delivery.

12. A non-transitory processor readable medium storing code representing instructions to be executed by a processor, the code comprising code to cause the processor to:

receive a first signal associated with movement of an actuator of a medicament delivery device relative to a housing of the medicament delivery device in a first direction from a first actuator position to a second actuator position to activate an energy storage member, the medicament delivery device configured to move a needle from a retracted position within the housing to a delivery position outside of the housing and to deliver a medicament via the needle in response to the actuator activating the energy storage member, a lock portion of the actuator configured to engage a corresponding portion of the housing to maintain the actuator in the second actuator position after delivery of the medicament, the needle configured to be moved independent from movement of the housing and in a proximal direction from the delivery position outside of the housing towards the retracted position within the housing;

identify an instruction stored in a memory associated with a use of the medicament delivery device, the instruction directing a user to seek medical attention; and

send, after delivery of a medicament from the medicament delivery device, a second signal to a speaker to cause the speaker to produce a recorded speech output associated with the instruction.

13. The non-transitory processor readable medium of claim 12, wherein the instruction is a first instruction and the recorded speech output is a first recorded speech output, the housing of the medicament delivery device defines an opening through which at least a portion of the needle is disposed when the needle is in the delivery position outside of the housing, the code further comprising code to cause the processor to:

receive a third electronic signal before receiving the first electronic signal, the third electronic signal associated with a cover being moved relative to the medicament delivery device from a first position to a second position, the cover configured to cover the opening and limit movement of actuator relative to the housing when the cover is in the first position;

identify a second instruction stored in the memory, the second instruction providing directions for how to use the medicament delivery device; and

send, in response to receiving the third electronic signal, a fourth electronic signal to cause the speaker to produce a second recorded speech output associated with second instruction.

14. The non-transitory processor readable medium of claim 12, further comprising code to cause the processor to:

send, in response to receiving the first signal, a third signal to cause a network interface to transmit data associated with movement of the actuator to a remote device.

16. A method, comprising:

receiving, in response to a proximal end protrusion of an actuator of a medicament delivery device actuating a switch when the actuator is moved relative to a housing of the medical delivery device in a first direction from a first actuator position to a second actuator position to activate an energy storage member, a first electronic signal, the medicament delivery device configured to deliver a medicament via a needle in response to the actuator activating the energy storage member, a lock portion of the actuator being engaged with a corresponding portion of the housing when the actuator is in the second actuator position to limit movement of the actuator in a second direction opposite the first direction after activation of the energy storage member;

sending, in response to receiving the first electronic signal, a second electronic signal to an output device to cause the output device to emit an electronic output associated with a use of the medicament delivery device; and

producing, in response to delivery of the medicament via the needle, a visual indication that is visible through an opening defined by the housing.

17. The method of claim 16, wherein the producing the visual indication includes moving a status indicator within the housing such that the status indicator is visible through the opening defined by the housing, the status indicator being spaced apart from the energy storage member.

18. The method of claim 16, wherein the producing the visual indication includes exposing a colored portion visible through the opening defined by the housing, the colored portion indicating that the medicament delivery device has been activated.

19. The method of claim 16, wherein the energy storage member is a non-electronic energy storage member.

20. The method of claim 16, wherein:

the output device is a speaker coupled to the housing; and

the electronic output is a recorded speech output.

21. The method of claim 16, wherein the electronic output is a first recorded speech output produced by a speaker, the first recorded speech output including a post-use instruction, the method further comprising:

receiving, in response to a needle sheath being removed from a location inside of the housing and about the needle, a third electronic signal before receiving the first electronic signal; and

sending, in response to receiving the third electronic signal, a fourth electronic signal to the speaker to cause the speaker to emit a second recorded speech output including a pre-use instruction.

22. The method of claim 16, wherein:

the visual indication is a first visual indication; and

the output device is a light output device, the electronic output is a second visual indication produced by the light output device.