CA2594627A1 - Devices, systems, and methods for medicament delivery - Google Patents

Devices, systems, and methods for medicament delivery Download PDF

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Publication number
CA2594627A1
CA2594627A1 CA 2594627 CA2594627A CA2594627A1 CA 2594627 A1 CA2594627 A1 CA 2594627A1 CA 2594627 CA2594627 CA 2594627 CA 2594627 A CA2594627 A CA 2594627A CA 2594627 A1 CA2594627 A1 CA 2594627A1
Authority
CA
Canada
Prior art keywords
auto
injector
vial
vials
longitudinal axis
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA 2594627
Other languages
French (fr)
Other versions
CA2594627C (en
Inventor
Evan T. Edwards
Eric S. Edwards
Mark J. Licata
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Intelliject Inc
Original Assignee
Intelliject, Llc
Evan T. Edwards
Eric S. Edwards
Mark J. Licata
Intelliject, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Intelliject, Llc, Evan T. Edwards, Eric S. Edwards, Mark J. Licata, Intelliject, Inc. filed Critical Intelliject, Llc
Priority to CA2762072A priority Critical patent/CA2762072C/en
Publication of CA2594627A1 publication Critical patent/CA2594627A1/en
Application granted granted Critical
Publication of CA2594627C publication Critical patent/CA2594627C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2046—Media being expelled from injector by gas generation, e.g. explosive charge
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2053—Media being expelled from injector by pressurised fluid or vacuum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2066—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically comprising means for injection of two or more media, e.g. by mixing
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/20—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
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    • A61M2005/2006—Having specific accessories
    • A61M2005/2013—Having specific accessories triggering of discharging means by contact of injector with patient body
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    • A61M2005/2026—Semi-automatic, e.g. user activated piston is assisted by additional source of energy
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    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/206—With automatic needle insertion
    • A—HUMAN NECESSITIES
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
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    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2073—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
    • A—HUMAN NECESSITIES
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3128—Incorporating one-way valves, e.g. pressure-relief or non-return valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1083—Tube connectors; Tube couplings having a plurality of female connectors, e.g. Luer connectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1088—Tube connectors; Tube couplings having a plurality of male connectors, e.g. Luer connectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/13—General characteristics of the apparatus with means for the detection of operative contact with patient, e.g. lip sensor
    • A—HUMAN NECESSITIES
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/14—Detection of the presence or absence of a tube, a connector or a container in an apparatus
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/18—General characteristics of the apparatus with alarm
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    • A61M2205/00—General characteristics of the apparatus
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    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A—HUMAN NECESSITIES
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    • A61M2205/00—General characteristics of the apparatus
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    • A—HUMAN NECESSITIES
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    • A61M2205/00—General characteristics of the apparatus
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    • A61M2205/6018—General characteristics of the apparatus with identification means providing set-up signals for the apparatus configuration
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    • A—HUMAN NECESSITIES
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    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A—HUMAN NECESSITIES
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    • A61M5/2448—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic comprising means for injection of two or more media, e.g. by mixing
    • A—HUMAN NECESSITIES
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    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
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    • A61M5/3287—Accessories for bringing the needle into the body; Automatic needle insertion

Abstract

Certain exemplary embodimets can comprise an auto-injector (1000), which can comprise: a vial (4300) configured to store and/or contain an injectable medicament, the vial defining a vial longitudinal axis, and a housing (1800) comprising the vial. In various embodiments, the injectable medicament can be a medicine, medication, drug, pharmaceutical, prescriptive, agent, antidote, anti-veno hormone, stimulant, vasodilator, anesthetic, and/or nutritional supplement that is substantially ready for injection.

Claims (50)

1. An auto-injector, comprising:
a vial configured to store a dry substance separately from a liquid with which the powder is mixable to form an injectable medicament, said vial defining a vial longitudinal axis;
a mixing actuator configured to cause the dry substance to contact the liquid;
a piston configured to move within said vial, said piston configured to transfer the injectable medicament from said vial and through a single needle, said piston distinct from said mixing actuator; and a force initiator configured to supply a driving force to the injectable medicament, said force initiator defining a force initiator longitudinal axis located non-co-axially with the vial longitudinal axis.
2. The auto-injector of claim 1, further comprising a frangible configured to resist mixing of the dry substance and the liquid.
3. The auto-injector of claim 1, further comprising a housing comprising said vial, said housing defining a length and width approximating a credit card and a thickness of less than one inch.
4. The auto-injector of claim 1, wherein said mixing actuator is coupled to said piston.
5. The auto-injector of claim 1, wherein said mixing actuator is coupled to said vial.
6. The auto-injector of claim 1, further comprising a compressed gas container configured to provide an actuation pressure to said piston.
7. The auto-injector of claim 1, further comprising an actuator configured to discharge an actuating portion of a contents of a compressed gas container fluidly coupled to said piston.
8. The auto-injector of claim 1, where said vial is fluidly coupleable to an actuating portion of a contents of a compressed gas container.
9. The auto-injector of claim 1, further comprising a channel configured to convey at least a portion of the injectable medicament from said vial to said single needle.
10. The auto-injector of claim 1, further coinprising said single needle.
11. The auto-injector of claim 1, further comprising a sheath configured to protect said single needle.
12. The auto-injector of claim 1, further comprising a sheath configured to conceal said single needle following injection of the injectable medicament.
13. The auto-injector of claim 1, further comprising a shield configured to guard said single needle following injection of the injectable medicament.
14. The auto-injector of claim 1, further comprising a safety tab configured to prevent accidental activation of said auto-injector.
15. The auto-injector of claim 1, further comprising a housing configured to contain said vial and said piston.
16. The auto-injector of claim 1, further comprising a housing configured to contain said vial and said piston said housing defining a length and width approximating a credit card and a thickness of less than one inch.
17. The auto-injector of claim 1, wherein said vial is one of a plurality of vials.
18. The auto-injector of claim 1, wherein said vial is one of a plurality of vials, each of said plurality of vials defining a vial longitudinal axis, the vial longitudinal axes of said plurality of vials parallel and non-co-axial.
19. The auto-injector of claim 1, wherein said vial is one of a plurality of vials, each of said plurality of vials defining a vial longitudinal axis, the vial longitudinal axes of said plurality of vials located non-co-axially with said force initiator longitudinal axis.
20. The auto-injector of claim 1, wherein said piston is one of a plurality of pistons.
21. An auto-injector, comprising:
a vial configured to store an injectable medicament, said vial defining a vial longitudinal axis;
a force initiator configured to supply a driving force to the injectable medicament, said force initiator defining a force initiator longitudinal axis located non-co-axially with the vial longitudinal axis;
a housing comprising said vial; and an output device coupled to said housing and configured to render a use indication to a user of said auto-injector, said use indication one of a group of use indications automatically triggerable by a microprocessor, said group not regarding a quantity of the injectable medicament, said group regarding at least two of:
auto-injector replacement;
medicament mixing;
injection delay;
safety guard removal;
auto-injector positioning;
auto-injector orientation;
actuator location;
injection hazard avoidance;
injection duration;
injection status;
injection error;
auto-injector removal;
auto-injector reuse;

auto-injector recycling; and auto-injector disposal.
22. The auto-injector of claim 21, wherein said housing defines a length and width approximating a credit card and a thickness of less than one inch.
23. The auto-injector of claim 21, wherein said use indication is triggered responsive to a value of a sensed variable.
24. The auto-injector of claim 21, wherein said use indication is triggered responsive to a user input.
25. The auto-injector of claim 21, wherein said use indication is triggered responsive to a determination of a hazardous condition.
26. The auto-injector of claim 21, wherein said use indication is rendered visually.
27. The auto-injector of claim 21, wherein said use indication is rendered audibly.
28. The auto-injector of claim 21, wherein said use indication is rendered hapticly.
29. The auto-injector of claim 21, wherein said housing comprises said output device.
30. The auto-injector of claim 21, wherein said output device comprises a speaker.
31. The auto-injector of claim 21, wherein said output device comprises a display.
32. The auto-injector of claim 21, wherein said output device comprises a light emitting diode.
33. The auto-injector of claim 21, wherein said output device comprises a vibrator.
34. The auto-injector of claim 21, wherein said output device comprises a heater.
35. The auto-injector of claim 21, further comprising said microprocessor, said microprocessor coupled to said housing.
36. The auto-injector of claim 21, further comprising a sensor coupled to said microprocessor.
37. The auto-injector of claim 21, further comprising a switch coupled to said microprocessor.
38. The auto-injector of claim 21, further comprising a battery coupled to said microprocessor.
39. The auto-injector of claim 21, further comprising a piston adapted to move within said vial..
40. The auto-injector of claim 21, further comprising said gas container.
41. The auto-injector of claim 21, further comprising a channel adapted to convey the at least a portion of the medicament from said vial to a needle.
42. The auto-injector of claim 21, wherein said injectable medicament is a liquid.
43. The auto-injector of claim 21, wherein said injectable medicament is a mixture of a liquid and a solid.
44. The auto-injector of claim 21, further comprising a spring adapted to retract a needle fluidly coupled to said vial.
45. The auto-injector of claim 21, further comprising a releasable actuation lock adapted to prevent accidental activation of said auto-injector.
46. The auto-injector of claim 21, wherein said vial is one of a plurality of vials.
47. The auto-injector of claim 21, wherein said vial is one of a plurality of vials, each of said plurality of vials defining a vial longitudinal axis, the vial longitudinal axes of said plurality of vials parallel and non-co-axial.
48. The auto-injector of claim 21, wherein said vial is one of a plurality of vials, each of said plurality of vials defining a vial longitudinal axis, the vial longitudinal axes of said plurality of vials located non-co-axially with said force initiator longitudinal axis.
49. The auto-injector of claim 21, wherein said vial is one of a plurality of vials, and further comprising a plurality of pistons, each of said plurality of pistons adapted to move within a corresponding one of said plurality of vials.
50. A computer readable medium comprising instructions for activities comprising:
via an output device of an auto-injector, rendering a use indication to a user of said auto-injector, said use indication one of a group of use indications automatically triggerable by a microprocessor, said group not regarding a quantity of the injectable medicament, said group regarding at least two of:
auto-injector replacement;
medicament mixing;
injection delay;
safety guard removal;
auto-injector positioning;
auto-injector orientation;
actuator location;
injection hazard avoidance;
injection duration;
injection status;
injection error;
auto-injector removal;
auto-injector reuse;
auto-injector recycling; and auto-injector disposal;
said auto-injector comprising:
a vial configured to store an injectable medicament, said vial defining a vial longitudinal axis;
a force initiator configured to supply a driving force to the injectable medicament, said force initiator defining a force initiator longitudinal axis located non-co-axially with the vial longitudinal axis;
and a housing comprising said vial, said output device coupled to said housing.
CA 2594627 2005-02-01 2006-02-01 Devices, systems, and methods for medicament delivery Active CA2594627C (en)

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