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

• US 9,555,191 B2
• Filed: 02/16/2016
• Issued: 01/31/2017
• Est. Priority Date: 01/22/2007
• 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): WAGGONER, TIMOTHY R
• Application Number:
  US15/044,337
• Publication Number:
  US 20160166768A1
• Time in Patent Office: 350 Days
• US Class Current: 1/1
• 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. An apparatus, comprising:

a container including a side wall defining a volume within which a medical injector can be disposed, a shape of the volume corresponding to a shape of the medical injector, the container including a lid movably coupled to the container, the lid configured to cover the volume when the lid is in a first position, the volume being exposed to allow access to the medical injector when the lid is in a second position; and

an electronic circuit system coupled to the container, the electronic circuit system including a first switch, a second switch, a light output device, an audible output device, and a wireless communication module, the first switch configured to be actuated when the lid is moved from the first position to the second position, the second switch disposed within the volume such that the second switch extends from the side wall of the container, the medical injector in contact with a portion of the side wall of the container when the medical injector is within the volume, the second switch configured to move from a first state to a second state when the medical injector is removed from within the volume, the electronic circuit system configured to transmit, via the wireless communication module, a first wireless signal, the first wireless signal being a short-range radio frequency signal indicating that the container is within a transmission range of a remote computing device, the electronic circuit system configured to transmit, via the wireless communication module, a second wireless signal in response to the second switch moving from the first state to the second state, the second wireless signal being a short-range radio frequency signal indicating that the medical injector has been removed, the electronic circuit system configured to receive, via the wireless communication module, a third wireless signal and produce, in response to the third wireless signal, at least one of a visual output from the light output device or an audible output from the audible output device.

2. The apparatus of claim 1, wherein the medical injector is a single-use autoinjector, the shape of the single-use autoinjector being non-circular.

3. The apparatus of claim 1, wherein the lid is hingedly coupled to the container.

4. The apparatus of claim 1, wherein the wireless communication module includes at least one of a microprocessor, a transmitter, a receiver, a transceiver, or a radio chipset.

5. The apparatus of claim 1, wherein the second wireless signal includes information that, when received by the remote computing device, causes the remote computing device to send a location signal associated with a location associated with the container.

6. The apparatus of claim 1, wherein the second wireless signal includes information that, when received by the remote computing device, causes the remote computing device to output an instruction associated with the medical injector.

7. The apparatus of claim 1, wherein the electronic circuit system includes a temperature sensor, the electronic circuit system configured to transmit, via the wireless communication module, a fourth wireless signal, the fourth wireless signal being a short-range radio frequency signal indicating a temperature of the container.

8. The apparatus of claim 1, wherein at least one of the first wireless signal or the second wireless signal is encrypted.

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

10. The apparatus of claim 1, wherein the second switch includes a biasing member configured to bias the second switch towards one of the first state or the second state.

11. The apparatus of claim 1, wherein the container defines the volume within which one and only one medical injector can be disposed, the apparatus further comprising:

the medical injector, the medical injector being an autoinjector including an injector housing and a medicament container containing epinephrine disposed within the injector housing, the injector housing in contact with the portion of the side wall of the container when the medical injector is within the volume, a length of the portion of the side wall being greater than a length of the injector housing,

the first wireless signal and the second wireless signal each being transmitted independently from an actuation of the autoinjector, at least one of the first wireless signal or the second wireless signal includes a unique identification associated with the autoinjector.

12. The apparatus of claim 11, wherein the second switch is configured to be reversibly moved between the first state and the second state.

13. An apparatus, comprising:

a container defining a volume within which a medical injector can be disposed, a shape of the volume corresponding to a shape of the medical injector, the container including a lid movably coupled to the container, the lid configured to cover the volume when the lid is in a first position, the volume being exposed to allow access to the medical injector when the lid is in a second position; and

an electronic circuit system coupled to the container, the electronic circuit system including a switch, a light output device, an audible output device, a temperature sensor, and a wireless communication module, the switch configured to move from a first state to a second state when the medical injector is removed from the volume, the electronic circuit system configured to transmit, via the wireless communication module, a first wireless signal, the first wireless signal being a short-range radio frequency signal indicating that the container is within a transmission range of a remote computing device, the electronic circuit system configured to transmit, via the wireless communication module, a second wireless signal in response to the switch moving from the first state to the second state, the second wireless signal being a short-range radio frequency signal indicating that the medical injector has been removed, the second wireless signal including information that, when received by the remote computing device, causes the remote computing device to output an instruction associated with the medical injector, the electronic circuit system configured to transmit, via the wireless communication module, a third wireless signal, the third wireless signal being a short-range radio frequency signal indicating a temperature of the container.

14. The apparatus of claim 13, wherein the medical injector is a single-use autoinjector having a distal end portion, a proximal end portion, and defining a longitudinal axis therebetween, the shape of the single-use autoinjector in a plane normal to the longitudinal axis being non-circular.

15. The apparatus of claim 14, wherein the volume defined by the container is elongated such that when the lid is in the second position, the single-use autoinjector can be removed from the volume by moving the single-use autoinjector along the longitudinal axis such that the proximal end portion is removed from the volume before the distal end portion is removed from the volume.

16. The apparatus of claim 13, wherein:

the medical injector is a single-use autoinjector; and

the container defines a recess configured to receive a protrusion of the single-use autoinjector to limit movement of the single-use autoinjector when the single-use autoinjector is disposed within the volume of the container.

17. The apparatus of claim 13, wherein the second wireless signal includes information that, when received by the remote computing device, causes the remote computing device to send a location signal associated with a location associated with the container.

18. The apparatus of claim 13, wherein:

the switch is a first switch; and

the electronic circuit system includes a circuit board and a second switch coupled to the circuit board, a portion of the lid configured to engage the second switch when the lid is moved between the first position and the second position to actuate the second switch, the electronic circuit system configured to produce an electronic output when the second switch is actuated.

19. An apparatus, comprising:

an autoinjector including a housing and a medicament container disposed within the housing;

a compliance monitor housing including a side wall defining a volume within which the autoinjector can be disposed, the compliance monitor housing including a lid configured to retain the autoinjector within the volume; and

an electronic circuit system coupled to the compliance monitor housing, the electronic circuit system including a first switch, a second switch, a light output device, an audible output device, and a wireless communication module, the first switch configured to be actuated when the lid is opened to expose the volume, the second switch coupled to the side wall of the compliance monitor housing, the autoinjector in contact with a portion of the side wall of the compliance monitor housing when the autoinjector is within the volume, the second switch configured to move from a first state to a second state when the autoinjector is removed from the compliance monitor housing, the electronic circuit system configured to transmit, via the wireless communication module, a first wireless signal, the first wireless signal being a short-range radio frequency signal indicating that the compliance monitor housing is within a transmission range of a remote computing device, the electronic circuit system configured to transmit, via the wireless communication module, a second wireless signal in response to the second switch moving from the first state to the second state, the second wireless signal being a short-range radio frequency signal, the electronic circuit system configured to receive, via the wireless communication module, a third wireless signal and produce, in response to the third wireless signal, at least one of a visual output from the light output device or an audible output from the audible output device.

20. The apparatus of claim 19, wherein the wireless communication module includes at least one of a microprocessor, a transmitter, a receiver, a transceiver, or a radio chipset.

21. The apparatus of claim 19, wherein the second wireless signal includes information that, when received by the remote computing device, causes the remote computing device to send a location signal associated with a location associated with the compliance monitor housing.

22. The apparatus of claim 19, wherein the second wireless signal includes information that, when received by the remote computing device, causes the remote computing device to output an instruction associated with the autoinjector.

23. The apparatus of claim 19, wherein the electronic circuit system includes a temperature sensor, the electronic circuit system configured to transmit, via the wireless communication module, a fourth wireless signal, the fourth wireless signal being a short-range radio frequency signal indicating a temperature of the compliance monitor housing.

24. The apparatus of claim 19, wherein the second switch extends from the sidewall of the compliance monitor housing, the second switch including a biasing member configured to bias the second switch towards one of the first state or the second state.