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

• US 8,361,026 B2
• Filed: 11/10/2009
• Issued: 01/29/2013
• 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:
  US12/615,636
• Publication Number:
  US 20100211005A1
• Time in Patent Office: 1,176 Days
• Field of Search: 604 65- 67, 604/890.1
• US Class Current: 604/137
• 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 coupled to a needle and configured to contain a dose of a medicament;

an activation mechanism including an energy storage member configured to produce a force to initiate movement of the needle between a first needle position and a second needle position, the needle being within the housing when the needle is in the first needle position, an end of the needle being outside of the housing through an opening defined by a distal end portion of the housing when the needle is in the second needle position to deliver the dose of the medicament;

an actuator having a first portion and a second portion, the first portion and the second portion configured to move when the actuator is actuated, the first portion of the actuator configured to actuate the activation mechanism when the actuator is actuated;

a container configured to receive at least a portion of the housing, the first container configured to be connected to a computing device;

and

an electronic circuit system coupled to at least one of the housing or the container, the electronic circuit system including a switch, the electronic circuit system configured to produce a wireless signal when the switch is moved from a first state to a second state, the second portion of the actuator configured to move the switch from the first state to the second state when the actuator is actuated, the electronic circuit system configured to transmit the wireless signal such that the computing device produces an output.

2. The apparatus of claim 1, wherein:

the computing device is a cell phone; and

the output is a recorded speech output.

3. The apparatus of claim 1, wherein the wireless signal is a first wireless signal, the apparatus further comprising:

a cover configured to be removably coupled about the distal end portion of the housing, the cover including a first portion and a second portion, the first portion of the cover covering the opening when the cover is coupled about the distal end portion of the housing, the second portion of the cover configured to actuate the electronic circuit system to produce a second wireless signal when the cover is removed from about the distal end portion of the housing.

4. The apparatus of claim 1, wherein the wireless signal is a first wireless signal, the electronic circuit system is configured to produce a second wireless signal when a second switch is actuated, the apparatus further comprising:

a cover including a first portion and a second portion, the first portion covering the opening when the cover is coupled about the distal end portion of the housing, the second portion configured to actuate the second switch when the cover is removed from about the distal end portion of the housing.

5. The apparatus of claim 1, wherein:

the computing device is a cell phone; and

the output includes a phone call.

6. An apparatus, comprising:

a medicament injector including a housing, a medicament container disposed within the housing and configured to contain a dose of a medicament, an energy storage member configured to produce a force to deliver the dose of the medicament, and an actuator, the actuator including a first portion and a second portion, the first portion and the second portion configured to move in response to movement of the actuator, the first portion of the actuator configured to actuate the energy storage member when the actuator is moved;

a cover configured to receive at least a portion of the housing, the cover configured to be connected to a computing device; and

an electronic circuit system coupled to at least one of the cover or the housing of the medicament injector, the electronic circuit system including a switch, the electronic circuit system configured to produce a wireless signal when the switch is moved from a first state to a second state, the second portion of the actuator configured to move the switch from the first state to the second state when the actuator is moved, the electronic circuit system configured to transmit the wireless signal such that the computing device produces an output.

7. The apparatus of claim 6, 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.

8. The apparatus of claim 6, wherein:

the computing device is a cell phone; and

the output is a recorded speech output.

9. The apparatus of claim 6, wherein the energy storage member is a non-electronic energy storage member.

10. The apparatus of claim 6, wherein the computing device is a cell phone.

11. The apparatus of claim 6, wherein the cover defines a recessed volume configured to matingly receive the portion of the housing of the medicament injector such that movement of the housing within the cover is limited when the actuator is moved.

12. The apparatus of claim 6, wherein the wireless signal is a short-range radio frequency signal having a frequency between approximately 2400 MHz and 2480 MHz.

13. The apparatus of claim 6, wherein:

the computing device is a cell phone; and

the output includes a phone call.

14. The apparatus of claim 6, wherein:

the wireless signal is a first wireless signal; and

the medicament injector includes a lock member removably coupled to the housing, a first portion of the lock member configured to limit movement of the actuator when the lock member is coupled to the actuator, a second portion of the lock member configured to actuate the electronic circuit system to produce a second wireless signal when the lock member is removed from the housing.

15. An apparatus, comprising:

a medicament injector including a medicament container configured to contain a dose of a medicament, an energy storage member configured to produce a force to deliver the dose of the medicament, and an actuator, the actuator including a first portion and a second portion, the first portion and the second portion configured to move in response to movement of the actuator, the first portion of the actuator configured to actuate the energy storage member when the actuator is moved; and

a cover configured to contain at least a portion of the medicament injector, the cover configured to be connected to a computing device;

at least one of the medicament injector or the cover including an electronic circuit system including a switch, the electronic circuit system configured to produce a wireless signal when the switch is moved from a first state to a second state, the second portion of the actuator configured to move the switch from the first state to the second state when the actuator is moved, the electronic circuit system configured to transmit the wireless signal such that the computing device produces an output.

16. The apparatus of claim 15, wherein:

the computing device is a cell phone; and

the output includes a phone call.

17. The apparatus of claim 15, wherein:

the computing device is a cell phone; and

the output is at least one of a visual output or a recorded speech output.

18. The apparatus of claim 15, wherein the cover defines a recessed volume configured to matingly receive the portion of the medicament injector such that movement of the medicament injector within the cover is limited when the actuator is moved.

19. The apparatus of claim 15, wherein the wireless signal is a short-range radio frequency signal having a frequency between approximately 2400 MHz and 2480 MHz.

20. The apparatus of claim 15, wherein:

the wireless signal is a first wireless signal; and

the medicament injector includes a lock member, a first portion of the lock member configured to limit movement of the actuator when the lock member is coupled to the medicament injector, a second portion of the lock member configured to actuate the electronic circuit system to produce a second wireless signal when the lock member is removed from the medicament injector.

21. The apparatus of claim 15, wherein the wireless signal is a first wireless signal, the output is a first output, the apparatus further comprising:

a lock member configured to be removably coupled about a distal end portion of the medicament injector, the electronic circuit system configured to produce a second wireless signal when the lock member is removed from about the distal end portion of the medicament injector, the electronic circuit system configured to transmit the second wireless signal to the computing device such that the computing device produces a second output.