Medicament delivery device having an electronic circuit system

• US 10,076,611 B2
• Filed: 01/12/2016
• Issued: 09/18/2018
• Est. Priority Date: 02/01/2005
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Kaleo, Inc.
• Inventors: Edwards, Eric S., Edwards, Evan T., Licata, Mark J., Meyers, Paul F., Weinzierl, David A.
• Primary Examiner(s): Schmidt, Emily
• Application Number:
  US14/993,234
• Publication Number:
  US 20160121056A1
• Time in Patent Office: 980 Days
• CPC Class Codes: A61M 15/0001 Details of inhalators; Constructional features thereof
• 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 2005/3125 specific display means, e.g. to indicate dose setting
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• 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 2205/584 having a color code
• CPC Class Codes: A61M 2205/587 Lighting arrangements
• 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 2205/6063 Optical identification systems
• CPC Class Codes: A61M 2205/8206 battery-operated
• 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 5/24 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 5/31 Details
• 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 5/3287 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: G09B 23/28 : for medicine
• CPC Class Codes: G09B 23/285 : for injections, endoscopy, bronchoscopy, sigmoidscopy, insertion of contraceptive devices or enemas
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection

Abstract

Medicament delivery devices are described herein. In some embodiments, an apparatus includes a medical injector and an electronic circuit system. The medical injector includes a housing, a medicament container, and a medicament delivery member. The housing defines a first region and a second region. The first region includes the medicament container and is physically isolated from the second region. The electronic circuit system is configured to be disposed within the second region defined by the housing. The electronic circuit system is configured to output an electronic output associated with a use of the medical injector.

Claims

1. An apparatus comprising:

a medicament delivery device configured to deliver a medicament, the medicament delivery device including a first housing and a medicament container, a distal end portion of the medicament container including a delivery member through which the medicament is conveyed, a side wall of the first housing defining an interior volume within which the distal end portion of the medicament container is contained;

a second housing including a connection portion configured to be coupled to a corresponding connection portion of the medicament delivery device when the second housing is coupled to the medicament delivery device; and

an electronic circuit system coupled to the second housing, the electronic circuit system including a switch, a light output device and a wireless network interface device, a non-electronic actuation surface of the medicament delivery device configured to engage the switch when the second housing is coupled to the medicament delivery device to transition the switch from a first state to a second state, the switch being maintained in the second state before, during, and after actuation of the medicament delivery device, the electronic circuit system configured to produce a light output via the light output device when the switch is changed from the first state to the second state, the electronic circuit system configured to receive an actuation signal when the medicament delivery device is actuated while the second housing is coupled to the medicament delivery device, the electronic circuit system configured to output, via the wireless network interface device, a wireless signal associated with the actuation signal.

2. The apparatus of claim 1, wherein the medicament delivery device is any one of a pen injector, an auto-injector, or an inhaler.

3. The apparatus of claim 1, wherein the electronic circuit system includes an audible output device, the electronic circuit system configured to produce an audible output via the audible output device.

4. The apparatus of claim 1, wherein the electronic circuit system includes a processor configured to transition from a first functional configuration to a second functional configuration when the switch is changed from the first state to the second state.

5. The apparatus of claim 4, wherein the processor is configured to produce a first signal having a first characteristic when the processor is in the first functional configuration and a second signal having a second characteristic when the processor is in the second functional configuration, the first characteristic different from the second characteristic.

6. The apparatus of claim 5, wherein the first characteristic is associated with at least one of a type of medicament, a medicament dosage, or a language.

7. The apparatus of claim 1, wherein the switch is configured to be reversibly moved between the first state and the second state.

8. The apparatus of claim 1, wherein:

the distal end portion of the medicament container is configured to move in a first direction within the interior volume in response to actuation of the medicament delivery device; and

the medicament delivery device includes a retraction member configured to move the distal end portion of the medicament container in a second direction within the interior volume after delivery of the medicament.

9. The apparatus of claim 1, wherein the electronic circuit system is coupled to the second housing such that the electronic circuit system is physically isolated from the first housing.

10. A method, comprising:

aligning an electronic circuit system with a medicament delivery device, the medicament delivery device including a first housing and a medicament container, a distal end portion of the medicament container including a delivery member through which a medicament is conveyed, a side wall of the first housing defining an interior volume within which the distal end portion of the medicament container is movably disposed, the electronic circuit system coupled to a second housing, the electronic circuit system including a processor, a first actuation substrate, a second actuation substrate, a light output device, and a wireless network interface device, the first actuation substrate including a first conductive member operably coupled to the processor, the second actuation substrate including a second conductive member operably coupled to the processor, the electronic circuit system configured to produce a first electronic output in response to actuation of the first actuation substrate, the electronic circuit system configured to produce a second electronic output in response to actuation of the second actuation substrate;

coupling the second housing to the medicament delivery device, a non-electronic connection portion of the medicament delivery device actuating the first actuation substrate as a result of the coupling; and

actuating the medicament delivery device to move the distal end portion of the medicament container within the interior volume from a first position to a second position to convey the medicament while the second housing is coupled to the medicament delivery device and the first actuation substrate remains actuated, the medicament container fluidically isolated from the delivery member when in the first position, the medicament container in fluid communication with the delivery member when in the second position, an actuator actuates the second actuation substrate of the electronic circuit system as a result of the actuating the medicament delivery device, the electronic circuit system producing the second electronic output in response to the actuator actuating the second actuation substrate, the second electronic output being at least one of a light output produced by the light output device or a wireless signal produced by the wireless network interface device.

11. The method of claim 10, wherein the medicament delivery device is any one of a pen injector, an auto-injector, or an inhaler.

12. The method of claim 10, wherein the processor is configured to transition from a first functional configuration to a second functional configuration when the first actuation substrate is actuated, and the second functional configuration is maintained before, during, and after actuation of the medicament delivery device.

13. The method of claim 12, wherein the processor is configured to produce a first signal having a first characteristic when the processor is in the first functional configuration and a second signal having a second characteristic when the processor is in the second functional configuration, the first characteristic different from the second characteristic.

14. The method of claim 10, wherein the electronic circuit system is physically isolated from the first housing after the second housing is coupled to the medicament delivery device.

15. An apparatus comprising:

a medicament delivery device configured to deliver a medicament when actuated, the medicament delivery device including a first housing and a medicament container, a distal end portion of the medicament container including a delivery member through which the medicament is conveyed, a side wall of the first housing defining an interior volume within which the distal end portion of the medicament container is disposed;

a second housing including a connection portion configured to align the second housing with the medicament delivery device when the second housing is coupled to the medicament delivery device; and

an electronic circuit system coupled to the second housing, the electronic circuit system including a processor, an actuation substrate, and an output device, the actuation substrate including a conductive member operably coupled to the processor, a non-electronic actuation surface of the medicament delivery device configured to deform the conductive member when the second housing is coupled to the medicament delivery device to transition the processor from a first functional configuration to a second functional configuration, the electronic circuit system configured to produce an electronic output via the output device in response to the processor being transitioned from the first functional configuration to the second functional configuration, the processor being maintained in the second functional configuration before, during, and after actuation of the medicament delivery device.

16. The apparatus of claim 15, wherein:

the output device includes at least one of a light output device or a wireless network interface device; and

the electronic output being at least one of a light output produced by the light output device or a wireless signal produced by the wireless network interface device.

17. The apparatus of claim 15, wherein:

the output device includes at least one of a light output device or an audible output device; and

the electronic output being at least one of a light output produced by the light output device or an audible output produced by the audible output device.

18. The apparatus of claim 15, wherein:

the electronic output is a first electronic output; and

the processor is configured to receive an actuation signal associated with the actuation of the medicament delivery device during a medicament delivery operation, the electronic circuit system configured to produce a second electronic output associated with the actuation signal.

19. The apparatus of claim 18, wherein:

the output device includes at least one of a light output device or a wireless network interface device;

the first electronic output being at least one of a first light output produced by the light output device or a first wireless signal produced by the wireless network interface device; and

the second electronic output being at least one of a second light output produced by the light output device or a second wireless signal produced by the wireless network interface device.

20. The apparatus of claim 15, wherein:

the electronic output is a first electronic output;

the actuation substrate is a first actuation substrate; and

the electronic circuit system includes a second actuation substrate including a second conductive member operably coupled to the processor, the second actuation substrate configured to engage an actuator when the medicament delivery device is actuated, the electronic circuit system configured to produce a second electronic output via the output device in response to the actuator engaging the second actuation substrate.

21. The apparatus of claim 15, wherein the actuation substrate is configured to reversibly engage the non-electronic actuation surface of the medicament delivery device to reversibly transition the processor from the first functional configuration to the second functional configuration.

22. The apparatus of claim 15, wherein the non-electronic actuation surface of the medicament delivery device is a protrusion of the first housing, the protrusion configured to separate the conductive member to irreversibly transition the processor from the first functional configuration to the second functional configuration.

23. The apparatus of claim 15, wherein the medicament delivery device is any one of a pen injector, an auto-injector, or an inhaler.

24. The apparatus of claim 15, wherein the medicament delivery device is an auto-injector containing a dose of epinephrine.

25. The apparatus of claim 15, wherein the distal end portion of the medicament container moves within the interior volume to place the medicament container in fluid communication with the delivery member in response to actuation of the medicament delivery device.

26. The apparatus of claim 15, wherein:

the distal end portion of the medicament container is configured to move in a first direction within the interior volume in response to actuation of the medicament delivery device; and

the medicament delivery device includes a retraction member configured to move the distal end portion of the medicament container in a second direction within the interior volume after delivery of the medicament.