Medicament delivery device having an electronic circuit system

• US 8,231,573 B2
• Filed: 05/12/2008
• Issued: 07/31/2012
• Est. Priority Date: 02/01/2005
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Intelliject Incorporated
• Inventors: Edwards, Eric S., Edwards, Evan T., Licata, Mark J., Meyers, Paul F., Weinzierl, David A.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): SCHMIDT, EMILY LOUISE
• Application Number:
  US12/119,016
• Publication Number:
  US 20080269689A1
• Time in Patent Office: 1,541 Days
• Field of Search: 604/92, 604/131, 604/189, 604/890.1
• US Class Current: 604/131
• 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 medical injector including a housing, a release member, an actuator, a medicament container, and a delivery member, the housing defining a first region and a second region, the first region of the housing including at least the medicament container, the second region of the housing being physically isolated from the first region of the housing by a side wall disposed between the first region and the second region; and

an electronic circuit system including a switch configured to be disposed within the second region of the housing, the electronic circuit system configured to output an electronic output when the switch is actuated,

the actuator including a first portion and a second portion configured to move substantially simultaneously when the actuator is moved from a first position to a second position, the first portion of the actuator configured to actuate the release member when the actuator is moved from the first position to the second position, the second portion of the actuator configured to actuate the switch when the actuator is moved from the first position to the second position.

2. The apparatus of claim 1, wherein the medical injector is configured to deliver only a single dose of a medicament.

3. The apparatus of claim 1, wherein the electronic output of the electronic circuit system is an audible output associated with at least one of an instruction for using the medical injector, a post-use procedure, or a compliance tracking procedure.

4. The apparatus of claim 1, wherein the electronic output includes a signal configured to be received by a remote device.

5. The apparatus of claim 1, wherein the electronic output is a first electronic output, the apparatus further comprising:

a cover configured to be disposed about a portion of the medical injector, the electronic circuit system configured to output a second electronic output when the cover is removed from the portion of the medical injector.

6. The apparatus of claim 1, wherein:

the electronic output is a first electronic output; and

the medical injector includes a safety lock movably coupled to the actuator, the safety lock configured to limit movement of the actuator when in a first safety lock position, the electronic circuit system configured to output a second electronic output when the safety lock is moved to a second safety lock position.

7. The apparatus of claim 1, wherein the electronic output includes a recorded speech output.

8. The apparatus of claim 1, wherein:

the electronic circuit system includes a printed circuit board having a substrate and an electrical conductor disposed on the substrate, the substrate configured to receive the second portion of the actuator, the second portion of the actuator being configured to disrupt the electrical conductor to actuate the switch when the actuator is moved from the first position to the second position.

9. The apparatus of claim 1, wherein:

the electronic output is a first electronic output; and

the medicament container and the delivery member collectively define a medicament delivery path, the electronic circuit system being physically isolated from the medicament delivery path, the electronic circuit system configured to output a second electronic output in response to a delivery of a medicament via the medicament delivery path.

10. The apparatus of claim 1, wherein:

the medical injector includes a carrier coupled to the medicament container and the delivery member, the carrier configured to move within the first region during an injection event, a portion of the carrier in contact with a surface of the side wall, the side wall disposed between the carrier and the electronic circuit system.

11. The apparatus of claim 1, wherein the delivery member is a needle.

12. The apparatus of claim 1, wherein:

the electronic output is a first electronic output; and

the medical injector includes a safety lock movably coupled to the actuator, a first portion of the safety lock configured to limit movement of the actuator when the safety lock is in a first safety lock position, a second portion of the safety lock configured to actuate the electronic circuit system to produce a second electronic output when the safety lock is moved from the first safety lock position to a second safety lock position.

13. The apparatus of claim 1, wherein:

the delivery member is a needle configured to move relative to the housing between a first needle position in which the needle is disposed within the housing and a second needle position in which a portion of the needle is disposed outside of a distal end portion of the housing;

the medical injector includes a delivery mechanism disposed within the housing, the delivery mechanism configured to produce a force to move the needle from the first needle position to the second needle position; and

a third portion of the actuator defines an opening through which the portion of the needle is disposed when the needle is in the second needle position.

14. The apparatus of claim 1, wherein the medicament container contains epinephrine.

17. The apparatus of claim 13, wherein:

the second portion of the actuator is configured to deform a portion of a printed circuit board to actuate the switch when the actuator is moved from the first position to the second position.

15. An apparatus, comprising:

a medicament delivery device including a housing, an actuator and a medicament container, the medicament container being disposed within a first region of the housing, the first region of the housing separated from a second region of the housing by a side wall; and

an electronic circuit system coupled to the housing, the electronic circuit system including a switch disposed within the second region of the housing, the electronic circuit system configured to output an electronic output when the switch is actuated,

the actuator including a first portion and a second portion each configured to move in a first direction when the actuator is moved from a first position to a second position, the first portion of the actuator configured to initiate delivery of a medicament from the medicament container when the actuator is moved from the first position to the second position, the second portion of the actuator configured to actuate the switch when the actuator is moved from the first position to the second position.

16. The apparatus of claim 15, wherein the first portion of the actuator moves substantially simultaneously with the second portion of the actuator when the actuator is moved from the first position to the second position.

18. The apparatus of claim 15, wherein the electronic output includes a recorded speech output.

19. The apparatus of claim 15, wherein the electronic output includes a signal configured to be received by a remote device.

20. The apparatus of claim 15, wherein:

the medicament delivery device includes a carrier coupled to the medicament container and a needle, the carrier configured to move within the housing in response to the actuator being moved from the first position to the second position, a portion of the carrier in contact with a surface of the side wall, the side wall disposed between the carrier and the electronic circuit system.

21. The apparatus of claim 15, wherein:

the medicament delivery device includes a needle configured to move in a second direction relative to the housing between a first needle position in which the needle is disposed within the housing and a second needle position in which a portion of the needle is disposed outside of a distal end portion of the housing;

the medical injector includes a delivery mechanism disposed within the housing, the delivery mechanism configured to produce a force to move the needle from the first position to the second position; and

the first portion of the actuator is configured to contact a portion of the delivery mechanism to initiate delivery of the medicament, a third portion of the actuator defines an opening through which the portion of the needle is disposed when the needle is in the second needle position.

22. The apparatus of claim 15, wherein the medicament container contains epinephrine.

23. An apparatus, comprising:

a medical injector including a housing, a medicament container, an actuator and a lock member, the housing defining a first region and a second region, the first region of the housing including at least the medicament container, the second region of the housing being physically isolated from the first region of the housing, the actuator configured to initiate delivery of a medicament from the medicament container, the lock member removably coupled to the housing such that a first portion of the lock member limits movement of the actuator when the lock member is coupled to the actuator; and

an electronic circuit system including a switch configured to be disposed within the second region of the housing, the electronic circuit system configured to output an electronic output when the switch is actuated,

a second portion of the lock member configured to actuate the switch when the lock member is removed from the housing.

24. The apparatus of claim 23, wherein the medical injector is configured to deliver only a single dose of a medicament.

25. The apparatus of claim 23, wherein the medicament container and a medicament delivery member collectively define a medicament delivery path, the second region of the housing being physically isolated from the medicament delivery path.

26. The apparatus of claim 23, wherein the housing includes a side wall disposed between the first region and the second region.

27. The apparatus of claim 23, wherein:

the medical injector includes a cover and a needle, the needle configured to move relative to the housing between a first needle position in which the needle is disposed within the housing and a second needle position in which a portion of the needle is disposed outside of a distal end portion of the housing;

a distal end portion of the housing defines a first opening in fluid communication with the first region and a second opening in fluid communication with the second region, the portion of the needle being disposed through the first opening when the needle is in the second needle position; and

the cover is configured to be disposed about a portion of the housing, the cover including an isolation member extending through the second opening and between a power source and the electronic circuit system when the cover is disposed about the portion of the housing.

28. An apparatus, comprising:

a medical injector including a housing, a medicament container, an actuator and a cover, the housing defining a first region and a second region, the second region of the housing being separated from the first region of the housing by a side wall, the first region of the housing including at least the medicament container, the actuator configured to initiate delivery of a medicament from the medicament container, the cover coupled to the housing such that a first portion of the cover is disposed about the actuator when the cover is coupled to the housing; and

an electronic circuit system configured to be coupled to the medical injector such that the electronic circuit system is disposed within the second region of the housing, the electronic circuit system configured to output an electronic output when the electronic circuit system is actuated,

a second portion of the cover disposed within the second region of the housing when the cover is coupled to the housing, the electronic circuit system configured to be actuated when the cover is removed from the housing.

29. The apparatus of claim 28, wherein:

the electronic output is a first electronic output;

the actuator includes a first portion and a second portion, the first portion of the actuator configured to initiate delivery of the medicament when the actuator is moved from a first position to a second position; and

the electronic circuit system includes a printed circuit board having a substrate and an electrical conductor disposed on the substrate, the substrate including an actuation portion configured to receive a the second portion of the actuator, the second portion of the actuator being configured to deform the actuation portion of the substrate when the actuator is moved from the first position to the second position, the electronic circuit system configured to output a second electronic output when the actuation portion of the substrate is deformed.

30. The apparatus of claim 28, wherein the electronic circuit system includes a housing and a printed circuit board coupled to the housing of the electronic circuit system, the printed circuit board including a switch, the electronic circuit system configured to be actuated when the switch is moved from a first state to a second state,

the housing of the electronic circuit system including an alignment portion configured to be coupled to a corresponding alignment portion the housing of the medical injector to align the switch with the second portion of the cover when the electronic circuit system is coupled to the medical injector.

31. The apparatus of claim 28, wherein the electronic circuit system includes a housing and a printed circuit board coupled to the housing of the electronic circuit system, the printed circuit board including a light output device, the electronic circuit system configured to produce a light output via the light output device when actuated,

the housing of the electronic circuit system defining an opening aligned with the light output device such that the light output is visible to a user when the electronic circuit system is coupled to the medical injector.