Apparatus and methods for self-administration of vaccines and other medicaments

• US 10,258,735 B2
• Filed: 11/04/2016
• Issued: 04/16/2019
• Est. Priority Date: 02/05/2007
• Status: Expired due to Fees

• 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): Waggoner, Timothy R
• Application Number:
  US15/343,452
• Publication Number:
  US 20170049954A1
• Time in Patent Office: 893 Days
• CPC Class Codes: A61M 15/0025 with caps
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 15/0081 Locking means
• CPC Class Codes: A61M 15/0083 Timers
• 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 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 2005/2026 Semi-automatic, e.g. user activated piston is assisted by additional source of energy
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 2202/0007 introduced into the body
• CPC Class Codes: A61M 2202/30 Vaccines
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• 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 2205/18 with alarm
• CPC Class Codes: A61M 2205/276 preventing unwanted use
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/332 Force measuring means
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3576 : with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/3584 : using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 : using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/3606 : cooled
• 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 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• 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 2205/6018 : providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6036 : characterised by physical shape, e.g. array of activating switches
• CPC Class Codes: A61M 2205/8206 : battery-operated
• CPC Class Codes: A61M 2209/01 : Remote controllers for specific apparatus
• CPC Class Codes: A61M 2209/06 : Packaging for specific medical equipment
• CPC Class Codes: A61M 2209/086 : Docking stations
• CPC Class Codes: A61M 5/002 : Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• 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 5/2053 : 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 5/2448 : comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/3129 : Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/31525 : Dosing burettes, pipettes B01L3/02
• 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 5/326 : 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 5/5086 : for indicating if defective, used, tampered with or unsterile
• 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 25/08 : Antiepileptics; Anticonvulsants
• CPC Class Codes: A61P 3/10 : for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 37/08 : Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14
• CPC Class Codes: A61P 5/28 : Antiandrogens
• CPC Class Codes: A61P 7/06 : Antianaemics
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

A medicament delivery device includes a housing, a medicament container disposed within the housing, an activation mechanism, a cover and an electronic circuit system. The activation mechanism includes an energy storage member configured to produce a force to deliver the dose of a medicament and/or vaccine. The cover is configured to receive at least a portion of the housing. The electronic circuit system is coupled to the housing such that a protrusion of the cover electrically isolates a battery from a portion of the electronic circuit system when the portion of the housing is received by the cover. The electronic circuit system is configured to be electrically coupled to the battery and to produce a recorded speech output when the portion of the housing is at least partially removed from the cover. The electronic circuit system configured to produce a signal when the activation mechanism is actuated.

Claims

1. A method, comprising:

moving a lid of a container from a first position to a second position such that a first switch of an electronic circuit system is actuated when the lid moves from the first position to the second position, the container including a side wall defining a volume within which a medical injector is disposed, the medical injector in contact with a portion of the side wall when the medical injector is within the volume, the lid covering the volume of the container when the lid is in the first position, the volume being exposed to allow access to the medical injector within the container when the lid is in the second position, the electronic circuit system producing a first signal when the first switch is actuated; and

removing the medical injector from the container such that a second switch of the electronic circuit system is actuated, the second switch disposed within the volume and extending from the side wall of the container, the electronic circuit system producing a second signal when the second switch is actuated, the second signal being a short-range radio frequency signal indicating that the medical injector has been removed from the container.

2. The method of claim 1, wherein:

the electronic circuit system is coupled to the container and includes a light output device;

an audible output device, and a wireless communication module;

the first signal being at least one of a visual output from the light output device or an audible output from the audible output device; and

the second signal being produced by the wireless communication module.

3. The method of claim 2, wherein the wireless communication module includes at least one of a microprocessor, a transmitter, a receiver, a transceiver, or a radio chipset.

4. The method of claim 2, wherein the electronic circuit system produces the second signal to include information that, when received by a remote computing device, causes the remote computing device to send a location signal associated with a location associated with the container.

5. The method of claim 4, herein the remote computing device is a mobile phone.

6. The method of claim 1, wherein the electronic circuit system produces the second signal to include information that, when received by a remote computing device, causes the remote computing device to output an instruction associated with the medical injector.

7. The method of claim 1, wherein:

the moving the lid of the container includes rotating the lid about a hinge connection, the electronic circuit system coupled to the container such that a portion of the lid engages the first switch when the lid is moved from the first position to the second position.

8. The method of claim 1, wherein the medical injector is an autoinjector including an injector housing and a medicament container within the injector housing, the medicament container containing epinephrine.

9. A method, comprising:

producing, from an electronic circuit system coupled to a compliance monitoring container, a first short-range radio frequency signal indicating that the compliance monitoring container is within a transmission range of a remote computing device, the compliance monitoring container including a lid and defining a volume, the lid covering the volume when the lid is in a first lid position, the volume being exposed when the lid is in a second lid position, the compliance monitoring container configured to contain a medical injector within the volume;

producing, from the electronic circuit system, a second short-range radio frequency signal indicating a temperature of the compliance monitoring container; and

producing, from the electronic circuit system and in response to an actuation of a removal switch, a third short-range radio frequency signal indicating that the medical injector has been removed from the volume of the compliance monitoring container, the third short-range radio frequency signal including information that, when received by the remote computing device, causes the remote computing device to output at least one of an instruction associated with the medical injector or a location signal associated with a location associated with the compliance monitoring container.

10. The method of claim 9, wherein the electronic circuit system includes a light output device and an audible output device, the method further comprising:

producing at least one of a visual output from the light output device or an audible output from the audible output device in response to the actuation of a lid switch, the lid switch actuated when the lid is moved from the first lid position to the second lid position.

11. The method of claim 9, wherein the electronic circuit system includes a wireless communication module, the first short-range radio frequency signal, the second short-range radio frequency signal, and the third short-range radio frequency signal each being produced by the wireless communication module.

12. The method of claim 9, wherein:

the compliance monitoring container includes a side wall that defines the volume;

the removal switch is disposed within the volume and is coupled to the side wall of the compliance monitoring container; and

the medical injector is in contact with a portion of the side wall when the medical injector is within the volume, the medical injector spaced apart from the portion of the side wall when the medical injector is removed from the volume.

13. The method of claim 12, wherein the removal switch is configured to be biased and reversibly actuated.

14. The method of claim 9, wherein the medical injector is an autoinjector including an injector housing and a medicament container within the injector housing, the medicament container containing epinephrine.

15. A method, comprising:

producing, from an electronic circuit system coupled to a compliance monitoring container, a first short-range radio frequency signal indicating that the compliance monitoring container is within a transmission range of a remote computing device, the compliance monitoring container including a lid and defining a volume, the lid covering the volume when the lid is in a first lid position, the volume being exposed when the lid is in a second lid position, the compliance monitoring container configured to contain a medical injector within the volume;

producing, from the electronic circuit system, at least one of a visual output or an audible output in response to an actuation of a lid switch, the lid switch actuated when the lid is moved from the first lid position to the second lid position; and

producing, from the electronic circuit system and in response to the actuation of a removal switch, a second short-range radio frequency signal indicating that the medical injector has been removed from the volume of the compliance monitoring container, the second short-range radio frequency signal including information that, when received by the remote computing device, causes the remote computing device to output at least one of an instruction associated with the medical injector or a location signal associated with a location associated with the compliance monitoring container.

16. The method of claim 15, wherein the electronic circuit system includes a light output device and an audible output device, the visual output produced from the light output device, the audible output produced from the audible output device.

17. The method of claim 15, wherein:

the compliance monitoring container includes a side wall that defines the volume;

the removal switch is disposed within the volume and is coupled to the side wall of the compliance monitoring container; and

the medical injector is in contact with a portion of the side wall when the medical injector is within the volume, the medical injector spaced apart from the portion of the side wall when the medical injector is removed from the volume.

18. The method of claim 17, wherein the removal switch is configured to be biased and reversibly actuated.

19. The method of claim 15, wherein the medical injector is an autoinjector including an injector housing and a medicament container within the injector housing, the medicament container containing epinephrine.