APPARATUS AND METHODS FOR SELF-ADMINISTRATION OF VACCINES AND OTHER MEDICAMENTS

• US 20100211005A1
• Filed: 11/10/2009
• Published: 08/19/2010
• Est. Priority Date: 02/01/2005
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Intelliject Incorporated
• Inventors: Meyers, Paul F., Edwards, Evan T., Licata, Mark J., Weinzierl, David A., EDWARDS, Eric S.
• Granted Patent: US 8,361,026 B2
• Time in Patent Office: Days
• US Class Current: 604/82
• 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 housing;

a medicament container disposed within the housing, the medicament container configured to contain a dose of a vaccine;

an activation mechanism including an energy storage member configured to produce a force to deliver the dose of the vaccine into a body; and

an electronic circuit system coupled to the housing, the electronic circuit system configured to calculate a stability parameter associated with the vaccine, the electronic circuit system configured to produce an output associated with the stability parameter when the electronic circuit system is actuated.

2. The apparatus of claim 1, further comprising:

a cover configured to receive at least a portion of the housing, the cover including a protrusion configured to electrically isolate a battery from the electronic circuit system when the portion of the housing is received by the cover,

the electronic circuit system configured to be actuated when the portion of the housing is at least partially removed from the cover.

3. The apparatus of claim 1, wherein the stability parameter is associated with a temperature history of the vaccine.

4. The apparatus of claim 1, wherein the vaccine includes a dry component and a diluent, the apparatus further comprising:

a mixing mechanism configured to mix the dry component and the diluent, the stability parameter is associated with the actuation of the mixing mechanism.

5. The apparatus of claim 1, wherein:

the output is a recorded speech output; and

the electronic circuit system is configured to produce a signal associated with the stability parameter when the activation mechanism is actuated.

6. The apparatus of claim 1, further comprising:

a disarming mechanism configured to prevent the activation mechanism from producing the force in response to a change in the stability parameter.

7. An apparatus, comprising:

a housing;

a medicament container disposed within the housing, the medicament container configured to contain a dose of a medicament;

an activation mechanism including an energy storage member configured to produce a force to deliver the dose of the medicament into a body;

a cover configured to receive at least a portion of the housing; and

an electronic circuit system 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 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.

8. The apparatus of claim 7, wherein the medicament is at least one of an influenza A vaccine, an influenza B vaccine, an influenza A (H1N1) vaccine, a hepatitis A vaccine, a hepatitis B vaccine, a haemophilus influenzae Type B (HiB) vaccine, a measles vaccine, a mumps vaccine, a rubella vaccine, a polio vaccine, a human papilloma virus (HPV) vaccine, a tetanus vaccine, a diptheria vaccine, a pertussis vaccine, a bubonic plague vaccine, a yellow fever vaccine, a cholera vaccine, a malaria vaccine, a smallpox vaccine, a pneumococcal vaccine, a rotavirus vaccine, a varicella vaccine or a meningococcus vaccine.

9. The apparatus of claim 7, wherein the recorded speech output includes an indication of a stability of the medicament.

10. The apparatus of claim 7, wherein the recorded speech output includes an indication of an amount of time elapsed after a temperature of the medicament has deviated outside of a predetermined temperature range.

11. The apparatus of claim 7, wherein:

the electronic circuit system is configured to calculate a stability parameter associated with a history of a temperature of the medicament; and

the recorded speech output is associated with the stability parameter.

12. The apparatus of claim 7, wherein the recorded speech output is a first recorded speech output, the medicament includes a dry component and a diluent, the apparatus further comprising:

a mixing mechanism configured to mix the dry component and the diluent, the electronic circuit system configured to produce a second recorded speech output associated with the actuation of the mixing mechanism.

13. The apparatus of claim 7, wherein the recorded speech output includes a first instruction associated with a regimen for administering multiple doses of the medicament and a second instruction associated with actuating the activation mechanism.

14. The apparatus of claim 7, wherein:

the electronic circuit system includes a sensor configured to produce a sensor output when an actuation portion of the housing is disposed in contact with the body, the electronic circuit system configured to produce the signal in response to the sensor output.

15. The apparatus of claim 7, further comprising:

a needle configured to be in fluid communication with the medicament container, the needle configured to be moved by the activation mechanism between a first position and a second position,

a distal end of the needle configured to be disposed within a portion of the body to deliver the dose of the medicament when the needle is in the second position, the signal including information associated with a characteristic of the portion of the body.

16. The apparatus of claim 7, wherein the energy storage member is a non-electronic energy storage member.

17. The apparatus of claim 7, further comprising:

a disarming mechanism configured to prevent the activation mechanism from producing the force when a stability parameter associated with the medicament is outside of a predetermined range of values.

18. A method, comprising:

actuating an electronic circuit system coupled to a first auto-injector containing a first dose of a vaccine; and

in response to a recorded speech output produced by the first auto-injector, actuating a delivery mechanism such that the first dose of the vaccine is delivered into a portion of a body of a patient, the actuating performed by the patient, the recorded speech output providing instructions associated with at least one of a stability of the first dose of the vaccine, an instruction for using the first auto-injector, an instruction for following a regimen associated with the vaccine, an instruction for using a second auto-injector containing a second dose of the vaccine or a post-injection instruction.

19. The method of claim 18, wherein:

the actuating the electronic circuit system includes removing the first auto-injector from a container, the container having a protrusion configured to electrically isolates a battery from the electronic circuit system when the first auto-injector is within the container, the electronic circuit system configured to be electrically coupled to the battery when the auto-injector is removed from the container.

20. The method of claim 18, wherein the electronic circuit system is configured to transmit a signal in response to the actuating, the signal associated with the delivery of the first dose of the vaccine.