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US20110083445A1 - Portable medical container with active temperature control - Google Patents

Portable medical container with active temperature control Download PDF

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Publication number
US20110083445A1
US20110083445A1 US12/899,547 US89954710A US2011083445A1 US 20110083445 A1 US20110083445 A1 US 20110083445A1 US 89954710 A US89954710 A US 89954710A US 2011083445 A1 US2011083445 A1 US 2011083445A1
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US
United States
Prior art keywords
temperature
container
inner container
power source
portable
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.)
Abandoned
Application number
US12/899,547
Inventor
Andrew Rudolph Heyd
Zbigniew Stanislaw Sobelewski
Paul Andrew Ashmore
Charles Powell Morris
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POWER*OTG Inc
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POWER*OTG 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
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Priority to US12/899,547 priority Critical patent/US20110083445A1/en
Assigned to POWER*OTG INCORPORATED reassignment POWER*OTG INCORPORATED ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ASHMORE, PAUL ANDREW, HEYD, ANDREW RUDOLPH, MORRIS, CHARLES POWELL, SOBELEWSKI, ZBIGNIEW STANISLAW
Publication of US20110083445A1 publication Critical patent/US20110083445A1/en
Abandoned legal-status Critical Current

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Classifications

    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25BREFRIGERATION MACHINES, PLANTS OR SYSTEMS; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS
    • F25B21/00Machines, plants or systems, using electric or magnetic effects
    • F25B21/02Machines, plants or systems, using electric or magnetic effects using Peltier effect; using Nernst-Ettinghausen effect
    • F25B21/04Machines, plants or systems, using electric or magnetic effects using Peltier effect; using Nernst-Ettinghausen effect reversible
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/44Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for cooling or heating the devices or media
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25BREFRIGERATION MACHINES, PLANTS OR SYSTEMS; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS
    • F25B27/00Machines, plants or systems, using particular sources of energy
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25DREFRIGERATORS; COLD ROOMS; ICE-BOXES; COOLING OR FREEZING APPARATUS NOT OTHERWISE PROVIDED FOR
    • F25D2400/00General features of, or devices for refrigerators, cold rooms, ice-boxes, or for cooling or freezing apparatus not covered by any other subclass
    • F25D2400/12Portable refrigerators
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25DREFRIGERATORS; COLD ROOMS; ICE-BOXES; COOLING OR FREEZING APPARATUS NOT OTHERWISE PROVIDED FOR
    • F25D2700/00Means for sensing or measuring; Sensors therefor
    • F25D2700/12Sensors measuring the inside temperature

Definitions

  • the present invention is directed to portable medical containers with active temperature controls for transporting drugs or medications.
  • the drugs are related to the medical condition of an individual, for example, in the case of Insulin.
  • medications may provide an antidote for a hazardous situation the individual may be exposed to, for example, a rattlesnake bite or bee sting.
  • the dosage of the drug or medication may need to be in close proximity to the individual, since only a few minutes or seconds may be available due to the susceptibility of the individual due to allergies, for example, or distance from medical facilities when the individual requires the drug or medication.
  • the drug or medication has storage temperature limits. When stored outside the limits, the drugs or medications may have reduced effectiveness, or even ineffectiveness.
  • antigens such as Epinephrine require storage in the temperature range of 15 degrees Celsius to 30 degrees Celsius, and ideally at 25 degrees Celsius.
  • a temperature-controlled portable container for carrying an injector.
  • the temperature-controlled portable container includes an outer container and an inner container disposed within the outer container.
  • the injector is stored within the inner container, and the inner container is constructed of a thermally conductive material.
  • the temperature-controlled portable container also includes a temperature control device, which maintains an inner container temperature above a first predetermined temperature and below a second predetermined temperature, where the second predetermined temperature is higher than the first predetermined temperature.
  • the temperature-controlled portable container also includes a processor subsystem and a portable power source. The portable power source is coupled to the temperature control device and the processor subsystem, and provides power to the temperature control device and the processor subsystem.
  • a method for maintaining an injector temperature in a temperature-controlled portable container includes measuring a temperature of an inner container.
  • the inner container is disposed within an outer container of the temperature-controlled portable container.
  • the method includes conveying thermal energy from an outer container of the temperature-controlled portable container to the inner container. If the temperature of the inner container is above the first predetermined temperature and below a second predetermined temperature, the method includes not conveying thermal energy between the outer container and the inner container. If the temperature of the inner container is above the second predetermined temperature, then the method includes conveying thermal energy from the inner container to the outer container.
  • a temperature-controlled portable container for carrying an injector.
  • the temperature-controlled portable container includes an outer container and an inner container, disposed within the outer container.
  • the injector is stored within the inner container, and the inner container is constructed of a thermally conductive material.
  • the temperature-controlled portable container also includes a temperature control device, and the temperature control device maintains an inner container temperature below a predetermined temperature.
  • the temperature-controlled portable container further includes a processor subsystem and a portable power source, coupled to the temperature control device and the processor subsystem.
  • the portable power source provides power to the temperature control device and the processor subsystem.
  • the processor subsystem measures the inner container temperature, and in response to measuring the inner container temperature, the processor subsystem enables the temperature control device to conduct thermal energy from the inner container to the outer container if the inner container temperature is above the predetermined temperature, and the processor subsystem prevents the temperature control device from conducting thermal energy between the inner container to the outer container if the inner container temperature is below the predetermined temperature.
  • Advantages of the present invention include a portable container that is easily carried by a single person to transport a dosage of a drug or medication. This provides a convenient way to transport the drug or medicine, and can be configured to be carried around the neck on a lanyard, or on a belt or pocket with a clip.
  • Another advantage of the present invention is a temperature control system for the drug or medication, which maintains the drug temperature within a safe storage range. The temperature storage range may be optimized for the specific medication carried.
  • a further advantage of the present invention is a means to recharge or replace a portable power source in the portable container in order to extend the time period during which temperature regulation is provides for the drug or medication.
  • FIG. 1 is an illustration of a first view of the temperature-controlled portable container in accordance with embodiments of the present invention.
  • FIG. 2 is an illustration of a second view of the temperature-controlled portable container in accordance with embodiments of the present invention.
  • FIG. 3 is a top view of internal and external components of the temperature-controlled portable container in accordance with embodiments of the present invention.
  • FIG. 4 is a first side view of internal and external components of the temperature-controlled portable container in accordance with embodiments of the present invention.
  • FIG. 5 is a second side view of internal and external components of the temperature-controlled portable container in accordance with embodiments of the present invention.
  • FIG. 6 is a side cutaway view of internal and external components of the temperature-controlled portable container in accordance with embodiments of the present invention.
  • FIG. 7 is a block diagram illustrating electrical components of an embodiment of the temperature-controlled portable container of the present invention.
  • FIG. 8 is a flowchart illustrating steps of active temperature control in accordance with the present invention.
  • the present invention is directed to the problem of having available a drug or medicine that can travel with an individual and be ready to use within seconds.
  • individuals have a unique susceptibility to certain toxins present in various plants or animals, and a specific antidote is required to counteract the toxic effects.
  • An autoinjector is commonly used for such applications.
  • certain man-made toxins such as biological or chemical toxins may be present on future battlefields or in conjunction with asymmetrical warfare.
  • the portable container contains one or more autoinjectors with one or more dosages of a drug or medication. If multiple autoinjectors are carried, they may each contain a different medication or antitoxin.
  • the portable container includes an active temperature control that automatically adjusts drug or medication temperature based on one or more pre-programmed temperature thresholds.
  • the temperature-controlled portable container is generally disposed oriented lengthwise along an axis.
  • a main body 104 serves as a rigid outer container, and protects the inner components from environmental and physical damage.
  • the main body 104 in one embodiment is constructed from an impact-resistant non-thermally conductive material such as ABS plastic, fiberglass, or carbon fiber. In other embodiments, the main body 104 is constructed from a thermally conductive material such as aluminum or steel. Although not shown in FIG. 1 , the main body 104 in some embodiments has an eyelet or other attachment point for a lanyard or rope/string.
  • a lanyard or rope/string allows the temperature-controlled portable container to be worn around the neck of a user or attached by rope/string to another portable assembly such as a golf bag or backpack.
  • the main body 104 is fixedly attached to a clip or other retaining mechanism that allows the temperature-controlled portable container to be attached to a shirt pocket or similar available location.
  • the temperature-controlled portable container has a lid 108 , which retains the drug or medication within the main body 104 .
  • the lid 108 provides tool-free access to the drug or medication, and is screwed or clipped on and off by the user.
  • a finger grip as shown in FIGS. 1 and 2 , may be provided to aid in easy attachment.
  • a rough or knurled surface treatment on the side of the lid 108 may be provided for the same purpose.
  • Tool-free access has the advantage of providing easy and fast access to the drug or medication, which a user may potentially need to access within seconds.
  • the lid 108 requires a tool to attach or remove the lid 108 to the main body 104 , such as a screwdriver.
  • the lid 108 is locked to the main body 104 , and requires a key or combination to remove the lid 108 .
  • the third embodiment may be of value if the drug or medication does not require instant access and a level of security is required to limit access to the drug or medicine.
  • the lid 108 in one embodiment is constructed of the same material as the main body 104 . In an alternate embodiment, the lid 108 is constructed of a different material as the main body 104 .
  • the temperature-controlled portable container also includes a heat sink 112 .
  • the heat sink 112 is a heat exchanger between ambient air outside the main body 104 and the vessel that holds the drug or medication within the temperature-controlled portable container.
  • the heat sink 112 is constructed of the same thermally-conductive material as the main body 104 , and in a second embodiment the heat sink 112 is part of the main body 104 .
  • the temperature-controlled portable container includes a display 116 .
  • the display 116 is a liquid crystal display (LCD).
  • the display 116 is one or more light-emitting diodes (LEDs).
  • the display 116 is sunlight readable.
  • the display is used to communicate one or more status items to a user.
  • the status items include an upper temperature threshold, which is the upper safe storage limit for the drug or medication contained within the temperature-controlled portable container.
  • the status items include a lower temperature threshold, which is the lower safe storage limit for the drug or medication contained within the temperature-controlled portable container.
  • the status items include the charge status for a portable power source within the temperature-controlled portable container.
  • the charge status includes the percent fully charged, or the time remaining for the portable power source to continue to maintain the drug or medication between specified temperature limits.
  • the status items include the current temperature of the vessel containing the drug or medication, or the ambient temperature.
  • the display 116 may also display selection menus or other status items.
  • FIG. 2 an illustration of a second view 200 of the temperature-controlled portable container in accordance with embodiments of the present invention is shown.
  • the second view 200 of the temperature-controlled portable container illustrates the same elements shown and described in FIG. 1 .
  • the second view 200 includes a communication port 204 .
  • a communication port 204 is not provided, and the temperature-controlled portable container has fixed and unmodifiable functionality.
  • the communication port 204 provides communication between an external computer, PDA, or cell phone and a processor within the temperature-controlled portable container.
  • the external computer, PDA, or cell phone allows the user or operator to change, reprogram, or verify operating parameters of the temperature-controlled portable container or run diagnostics.
  • the communication port 204 provides a means to recharge the portable power source within the temperature-controlled portable container. In other embodiments, the communication port 204 provides a mean to power the temperature-controlled portable container from an external power source. In such a case, the connected external power source prevents the portable power source within the temperature-controlled portable container from discharging, such as when being transported on an aircraft, train, or automobile. In some embodiments, a connector separate from the communication port 204 is used to power the temperature-controlled portable container or recharge the portable power source.
  • the communication port 204 in a preferred embodiment is a USB port, although other interfaces such as fire wire or RS-232 may alternatively be used.
  • FIG. 3 a top view 300 of internal and external components of the temperature-controlled portable container in accordance with embodiments of the present invention is shown.
  • the top view 300 omits the main body 104 in order to show internal components of the temperature-controlled portable container.
  • Section lines B-B are provided in FIG. 3 , and refer to the section B-B illustration of FIG. 6 . From FIGS. 1 and 2 , Lid 108 , heat sink 112 , display 116 , and communication port 204 are illustrated.
  • the temperature-controlled portable container has an inner housing 304 , which provides the inner container or storage vessel for the drug or medication.
  • the inner housing 304 is constructed from a thermally conductive material, and in a preferred embodiment is Aluminum.
  • the inner housing 304 is arranged lengthwise within the main body 104 .
  • the inner housing 304 is open at the end where the lid 108 is attached, and is sealed at the opposite end.
  • inner housing 304 is open at both ends, and a lower thermal conductor 404 is coupled to the end opposite the lid 108 .
  • the drug or medication is contained within an epinephrine autoinjector (or Epi pen), Anapen, or Twinject.
  • An Epi pen is a medical device used to deliver a measured dose (or doses) of epinephrine, also known as adrenaline, using autoinjector technology. Epi pens are most frequently for the treatment of acute allergic reactions to avoid or treat the onset of anaphylactic shock.
  • the devices contain a spring-loaded needle that exits the tip of the device (in some cases through a sterile membrane) and into the recipient's body to deliver the medication.
  • Epinephrine autoinjectors contain a pre-determined dose of epinephrine, usually between 0.3 mg and 0.5 mg of active ingredient at a concentration of 1:1000. Manufacturers have also made pediatric dosed versions available at 0.15 mg of active ingredient, and there is also a version which contains two individual doses (in case a repeated application is required) sold under the trade name Twinject.
  • An injector includes any such device that an individual may administer to himself or another, including autoinjectors, Epi pens, Anapens, or Twinjects.
  • the temperature-controlled portable container has a centering ring 308 .
  • the centering ring 308 locates the inner housing 304 within the rear part of the main body 104 .
  • the centering ring 308 is preferably constructed of a thermally insulating material, and assists in thermal isolation of the inner housing 304 from main body 104 .
  • the temperature-controlled portable container has a front bushing 312 .
  • the front bushing 312 locates the inner housing 304 within the front part of the main body 104 , and in one embodiment provides the attachment point for the lid 108 .
  • the front bushing 312 is preferably constructed of a thermally insulating material, and assists in thermal isolation of the inner housing 304 from the main body 104 and lid 108 .
  • An electronics assembly 344 is contained within the temperature-controlled portable container.
  • the electronic assembly 344 includes a processor, memory, and other components supporting the portable power source, and is described in more detail with respect to FIG. 7 .
  • the components of the electronics assembly 344 are mounted on a printed circuit board, or PCB.
  • thermoelectric element wires 332 Also shown in FIG. 3 are wedge 328 , thermoelectric element wires 332 , solenoid 336 , and solenoid actuator 340 .
  • the function of these elements is described in more detail with respect to FIGS. 4 , 5 , 7 , and 8 .
  • FIG. 4 a first side view 400 of internal and external components of the temperature-controlled portable container in accordance with embodiments of the present invention is shown.
  • the first side view 400 omits the main body 104 in order to show internal components of the temperature-controlled portable container.
  • FIG. 4 illustrates additional components.
  • the temperature-controlled portable container includes a lower thermal conductor 404 .
  • the lower thermal conductor 404 is coupled directly to the inner housing 304 , and is constructed of a thermally conductive material such as Aluminum. In one embodiment, the lower thermal conductor 404 is part of the inner housing 304 .
  • the lower thermal conductor 404 conducts thermal energy between the inner housing 304 and a wedge 328 , when the wedge 328 is engaged with the lower thermal conductor 404 and an upper thermal conductor 408 .
  • the temperature-controlled portable container includes an upper thermal conductor 408 .
  • the upper thermal conductor 408 is coupled directly to a thermoelectric element 412 , and is constructed of a thermally conductive material such as Aluminum.
  • the upper thermal conductor 408 conducts thermal energy between the thermoelectric element 412 and the wedge 328 , when the wedge 328 is engaged with the lower thermal conductor 404 and the upper thermal conductor 408 .
  • the temperature-controlled portable container includes a thermoelectric element 412 .
  • the thermoelectric element 412 is a Peltier device.
  • a Peltier device is a solid-state active heat pump which transfers heat from one side of the device to the other side against the temperature gradient (from cold to hot), with consumption of electrical power from the portable power source.
  • a Peltier device may be desirable when a single device is to be used for both heating and cooling. When biased in a first manner, a first side cools while a second side warms. When biased in a second manner, the second side warms while the first side cools. The effectiveness of the pump at moving the heat away from the cold side is dependent upon the amount of current provided and how well the heat can be removed from the hot side.
  • Thermoelectric element wires 332 provide means for the electronics assembly 344 to control the operation of the thermoelectric element 412 .
  • a solenoid 336 is coupled to a solenoid actuator 340 , which in turn is coupled to the wedge 328 .
  • the solenoid 336 controls the position of the wedge 328 , by extending the wedge 328 when the solenoid 336 is activated, and retracting the wedge 328 when the solenoid 336 is deactivated.
  • the solenoid 336 is activated, the wedge 328 makes direct contact with the lower thermal conductor 404 and the upper thermal conductor 408 . This, in turn, allows thermal conduction between the heat sink 112 , the thermoelectric element 412 , the upper thermal conductor 408 , the lower thermal conductor 404 , and the inner housing 304 .
  • FIG. 4 illustrates the wedge 328 position when the solenoid 336 is activated.
  • FIG. 5 a second side view 500 of internal and external components of the temperature-controlled portable container in accordance with embodiments of the present invention is shown.
  • the second side view 500 omits the main body 104 in order to show internal components of the temperature-controlled portable container.
  • FIG. 5 is similar to FIG. 4 , but illustrates the wedge 328 position when the solenoid 336 is deactivated.
  • the wedge 328 is removed from direct contact with the lower thermal conductor 404 and the upper thermal conductor 408 . This, in turn, prevents thermal conduction between the heat sink 112 and the thermoelectric element 412 , and the upper thermal conductor 408 , lower thermal conductor 404 , and the inner housing 304 .
  • FIG. 5 illustrates the wedge 328 position when the solenoid 336 is deactivated.
  • FIG. 6 a side cutaway view 600 of internal and external components of the temperature-controlled portable container in accordance with embodiments of the present invention is shown.
  • FIG. 6 follows section B-B of FIG. 3 , in order to provide additional detail 600 of the temperature-controlled portable container. All of the components shown in FIGS. 1-5 are present in FIG. 6 .
  • An Epi Pen 604 is placed within the inner housing 304 for temperature controlled transportation.
  • An air gap 608 is between the Epi Pen 604 and the inner housing 304 .
  • the temperature-controlled portable container also includes an air gap 608 between the inner housing 304 and the main body 104 .
  • FIG. 7 a block diagram 700 illustrating electrical components of an embodiment of the temperature-controlled portable container of the present invention is shown.
  • the electrical components include a processor 704 , which controls the operation of the thermoelectric element 412 , solenoid 336 , audible transducer 732 , display 116 , and communication port 204 .
  • the processor 704 receives input from one or more temperature sensors 720 , pushbuttons 724 , and the communication port 204 .
  • the processor 704 is a low-power, highly integrated microprocessor or microcontroller such as a microprocessor from the ARM Ltd. family of embedded microprocessors. Such microprocessors have integrated I/O ports, analog-to-digital converters, and other features that allow integration into small and miniature devices similar to the temperature-controlled portable container.
  • Processor 704 communicates with memory 708 , which includes volatile memory and non-volatile memory.
  • Memory 708 includes at least a first predetermined temperature 712 , but may additionally include a second predetermined temperature 716 . In one embodiment, at least part of memory 708 is integrated into processor 704 .
  • the first predetermined temperature 712 and second predetermined temperature 716 are programmed into memory 708 during a manufacturing process for the temperature-controlled portable container.
  • pushbuttons 724 allow a user or operator to navigate menus on the display 116 to change operating parameters of the temperature-controlled portable container, including the first 712 and second 716 predetermined temperatures.
  • a computer, PDA, or cell phone attached to communication port 204 allow a user or operator to navigate menus on the display 116 to change operating parameters of the temperature-controlled portable container, including the first 712 and second 716 predetermined temperatures.
  • Portable power source 728 may in some embodiments include a rechargeable power device such as one or more batteries or capacitors. When a rechargeable power device or devices are used in the portable power source 728 , a charging circuit is also present in portable power source 728 . Portable power source 728 receives external power 736 in order to recharge the rechargeable power device or devices and in some embodiments external power 736 powers the entire temperature-controlled portable container when external power 736 is present.
  • communication port 204 is both a communication port 204 and a connector for external power 736 .
  • a USB port provides the functionality of a combined communication port 204 and external power source 736 .
  • portable power source 728 is one or more replaceable batteries, such as batteries using alkaline technologies.
  • the portable power source 728 is a rechargeable battery or capacitor and one or more solar cells recharge the battery or capacitor.
  • the portable power source 728 is a rechargeable battery or capacitor and a motion/vibration-to-energy device recharges the battery or capacitor.
  • no battery or capacitor for energy storage is present, and a renewable power source provides power to the temperature-controlled portable container. Power sources such as solar cells or motion/vibration-to-energy devices are renewable power sources.
  • an audible transducer 732 is present in the temperature-controlled portable container.
  • the audible transducer 732 produces predetermined tones, based on specific conditions detected by the processor 704 . For example, one type of tone is produced when the portable power source 728 is just about to run out of power. A second type of tone is produced when a predetermined amount of time is left for the portable power source 728 to maintain the Epi Pen 604 between the first 712 and second 716 predetermined temperatures. A third type of tone is produced when external power 736 is supplied to the portable power source 728 and the portable power source is being recharged. A fourth type of tone is produced when a diagnostics failure occurs. A fifth type of tone is produced when a failure is detected with the solenoid 336 , thermoelectric element 412 , temperature sensor 720 , communication port 204 , display 116 , pushbuttons 724 , or memory 708 .
  • the processor 704 periodically reads a temperature sensor 720 coupled to the inner housing 304 .
  • the inner housing 304 temperature approximates the Epi Pen 604 temperature, which in turn approximates the drug or medication temperature inside the Epi Pen 604 .
  • different temperature derating factors are applied to the inner housing 304 temperature in order to determine with accuracy the temperature of the drug or medication.
  • the temperature-controlled portable container includes more than one temperature sensor 720 . Additional temperature sensors may provide inputs from the heat sink 112 (ambient air), thermoelectric element 412 , or the main body 104 .
  • the processor 704 controls the thermoelectric element 412 and solenoid 336 to manage thermal conduction as shown and described with reference to FIG. 8 .
  • FIG. 8 a flowchart illustrating steps of active temperature control in accordance with the present invention is shown. Flow begins at block 804 .
  • the portable device powers-up, or is manually reset.
  • Power up includes initial portable power source 728 installation and activation or replacing the portable power source 728 .
  • Manual reset is any user-initiated operation to reset the temperature-controlled portable container, including through pushbuttons 724 or through a command transmitted through communication port 204 from a computer, PDA, or cell phone. Flow proceeds to block 808 .
  • a timer in the processor 704 expires.
  • the timer determines the sampling frequency of the temperature sensors 720 by the processor 704 .
  • the timer expires every minute.
  • the timer expires every five minutes.
  • the timer expires at a different time period than one minute or five minutes.
  • the timer is automatically restarted when it expires. Flow proceeds to block 812 .
  • the processor 704 reads the temperature sensors 720 . Flow proceeds to decision block 816 .
  • the processor 704 determines if the temperature read from the temperature sensors 720 is above the first predetermined value 712 .
  • the first predetermined value, or temperature 712 is the low-limit, below which the drug or medication will deteriorate or become ineffective. If the temperature read from the temperature sensors 720 is above the first predetermined value 712 , then relative to the first predetermined temperature 712 the temperature is acceptable and flow proceeds to decision block 820 . If the temperature read from the temperature sensors 720 is not above the first predetermined value 712 , then relative to the first predetermined temperature 712 the temperature is not acceptable and flow proceeds to block 828 .
  • the processor 704 determines if the temperature read from the temperature sensors 720 is below the second predetermined value 716 .
  • the second predetermined value, or temperature 716 is the high-limit, above which the drug or medication will deteriorate or become ineffective. If the temperature read from the temperature sensors 720 is below the second predetermined value 716 , then relative to the second predetermined temperature 716 the temperature is acceptable and flow proceeds to block 824 . If the temperature read from the temperature sensors 720 is not below the second predetermined value 716 , then relative to the second predetermined temperature 716 the temperature is not acceptable and flow proceeds to block 832 .
  • the processor 704 de-energizes the solenoid 336 . This causes the solenoid 336 to retract from the upper thermal conductor 408 and the lower thermal conductor 404 , which prevents thermal conduction between the Epi pen 604 and the heat sink 412 , as shown in FIG. 5 b . Without thermal conduction, the Epi pen 604 will tend to have the same temperature as ambient temperature. Flow proceeds to block 808 to wait for the timer to expire.
  • the processor 704 configures the thermoelectric element 412 to conduct thermal energy from the outer container (main body 104 ) to the inner container (inner housing 304 ).
  • Block 828 applies when the Epi pen 604 is too cold, or below the first predetermined temperature 712 . Therefore, the thermoelectric element 412 is configured in such a way to cause the “hot” side to face the heat sink 112 , and the “cold” side to face the upper thermal conductor 408 .
  • Flow proceeds to block 836 .
  • the processor 704 configures the thermoelectric element 412 to conduct thermal energy from the inner container (inner housing 304 ) to the outer container (main body 104 ).
  • Block 832 applies when the Epi pen 604 is too warm, or above the second predetermined temperature 716 . Therefore, the thermoelectric element 412 is configured in such a way to cause the “cold” side to face the heat sink 112 , and the “hot” side to face the upper thermal conductor 408 .
  • Flow proceeds to block 836 .
  • the processor 704 energizes the solenoid 336 .
  • This causes the solenoid 336 to make contact with the upper thermal conductor 408 and the lower thermal conductor 404 , which allows thermal conduction between the Epi pen 604 and the heat sink 412 , as shown in FIG. 5 a .
  • the Epi pen 604 will either increase in temperature (if flow was from block 828 ) or decrease in temperature (if flow was from block 832 ).
  • Flow proceeds to block 808 to wait for the timer to expire.

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Abstract

A temperature-controlled portable container for carrying an injector is provided. The temperature-controlled portable container includes an outer container and an inner container disposed within the outer container. The injector is stored within the inner container, and the inner container is constructed of a thermally conductive material. The temperature-controlled portable container also includes a temperature control device, which maintains an inner container temperature above a first predetermined temperature and below a second predetermined temperature, where the second predetermined temperature is higher than the first predetermined temperature. The temperature-controlled portable container also includes a processor subsystem and a portable power source. The portable power source is coupled to the temperature control device and the processor subsystem, and provides power to the temperature control device and the processor subsystem.

Description

    CROSS REFERENCE TO RELATED APPLICATION(S)
  • This application claims the benefit of pending U.S. Provisional Application Ser. No. 61/249,984 filed Oct. 8, 2009, entitled THE MEDICAL SUPPLY CONTAINER WITH AN ACTIVE TEMPERATURE CONTROL, which is hereby incorporated by reference for all purposes.
  • FIELD
  • The present invention is directed to portable medical containers with active temperature controls for transporting drugs or medications.
  • BACKGROUND
  • Individuals sometimes require ready access to specific drugs or medications. Paramedics and Emergency Response Teams operate in the field where portability and extended functionality are keys to success. In some cases, the drugs are related to the medical condition of an individual, for example, in the case of Insulin. In other cases, medications may provide an antidote for a hazardous situation the individual may be exposed to, for example, a rattlesnake bite or bee sting. In many cases, the dosage of the drug or medication may need to be in close proximity to the individual, since only a few minutes or seconds may be available due to the susceptibility of the individual due to allergies, for example, or distance from medical facilities when the individual requires the drug or medication.
  • Sometimes, the drug or medication has storage temperature limits. When stored outside the limits, the drugs or medications may have reduced effectiveness, or even ineffectiveness. For example, antigens such as Epinephrine require storage in the temperature range of 15 degrees Celsius to 30 degrees Celsius, and ideally at 25 degrees Celsius.
  • If the ambient conditions of the environment where the drugs or medications are stored is within the specified temperature limits, then only secondary precautions must be taken, if needed. For example, preventing exposure to direct sunlight. However, environmental conditions often change and the importance of having a ready supply of a necessary drug or medication regardless of environmental conditions is important in many cases.
  • SUMMARY
  • The present invention is directed to solving disadvantages of the prior art. In accordance with embodiments of the present invention, a temperature-controlled portable container for carrying an injector is provided. The temperature-controlled portable container includes an outer container and an inner container disposed within the outer container. The injector is stored within the inner container, and the inner container is constructed of a thermally conductive material. The temperature-controlled portable container also includes a temperature control device, which maintains an inner container temperature above a first predetermined temperature and below a second predetermined temperature, where the second predetermined temperature is higher than the first predetermined temperature. The temperature-controlled portable container also includes a processor subsystem and a portable power source. The portable power source is coupled to the temperature control device and the processor subsystem, and provides power to the temperature control device and the processor subsystem.
  • In accordance with other embodiments of the present invention, a method for maintaining an injector temperature in a temperature-controlled portable container is provided. The method includes measuring a temperature of an inner container. The inner container is disposed within an outer container of the temperature-controlled portable container. In response to measuring the temperature of the inner container, if the temperature of the inner container is below a first predetermined temperature, then the method includes conveying thermal energy from an outer container of the temperature-controlled portable container to the inner container. If the temperature of the inner container is above the first predetermined temperature and below a second predetermined temperature, the method includes not conveying thermal energy between the outer container and the inner container. If the temperature of the inner container is above the second predetermined temperature, then the method includes conveying thermal energy from the inner container to the outer container.
  • In accordance with yet other embodiments of the present invention, a temperature-controlled portable container for carrying an injector is provided. The temperature-controlled portable container includes an outer container and an inner container, disposed within the outer container. The injector is stored within the inner container, and the inner container is constructed of a thermally conductive material. The temperature-controlled portable container also includes a temperature control device, and the temperature control device maintains an inner container temperature below a predetermined temperature. The temperature-controlled portable container further includes a processor subsystem and a portable power source, coupled to the temperature control device and the processor subsystem. The portable power source provides power to the temperature control device and the processor subsystem. The processor subsystem measures the inner container temperature, and in response to measuring the inner container temperature, the processor subsystem enables the temperature control device to conduct thermal energy from the inner container to the outer container if the inner container temperature is above the predetermined temperature, and the processor subsystem prevents the temperature control device from conducting thermal energy between the inner container to the outer container if the inner container temperature is below the predetermined temperature.
  • Advantages of the present invention include a portable container that is easily carried by a single person to transport a dosage of a drug or medication. This provides a convenient way to transport the drug or medicine, and can be configured to be carried around the neck on a lanyard, or on a belt or pocket with a clip. Another advantage of the present invention is a temperature control system for the drug or medication, which maintains the drug temperature within a safe storage range. The temperature storage range may be optimized for the specific medication carried. A further advantage of the present invention is a means to recharge or replace a portable power source in the portable container in order to extend the time period during which temperature regulation is provides for the drug or medication. Another advantage of the present invention is the ability to visually monitor the storage temperature of the drug or medicine and other parameters, including ambient air temperature and time remaining for the portable power source to maintain the drug or medication at the specified temperature, given the ambient temperature. Yet another advantage of the present invention is the ability to change the storage temperature range of the drug or medication.
  • Additional features and advantages of embodiments of the present invention will become more readily apparent from the following description, particularly when taken together with the accompanying drawings.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • FIG. 1 is an illustration of a first view of the temperature-controlled portable container in accordance with embodiments of the present invention.
  • FIG. 2 is an illustration of a second view of the temperature-controlled portable container in accordance with embodiments of the present invention.
  • FIG. 3 is a top view of internal and external components of the temperature-controlled portable container in accordance with embodiments of the present invention.
  • FIG. 4 is a first side view of internal and external components of the temperature-controlled portable container in accordance with embodiments of the present invention.
  • FIG. 5 is a second side view of internal and external components of the temperature-controlled portable container in accordance with embodiments of the present invention.
  • FIG. 6 is a side cutaway view of internal and external components of the temperature-controlled portable container in accordance with embodiments of the present invention.
  • FIG. 7 is a block diagram illustrating electrical components of an embodiment of the temperature-controlled portable container of the present invention.
  • FIG. 8 is a flowchart illustrating steps of active temperature control in accordance with the present invention.
  • DETAILED DESCRIPTION
  • The present invention is directed to the problem of having available a drug or medicine that can travel with an individual and be ready to use within seconds. Sometimes, individuals have a unique susceptibility to certain toxins present in various plants or animals, and a specific antidote is required to counteract the toxic effects. An autoinjector is commonly used for such applications. In addition to natural toxins found in nature or wilderness areas, certain man-made toxins such as biological or chemical toxins may be present on future battlefields or in conjunction with asymmetrical warfare.
  • What is needed is a portable container that can be carried by an individual and either attached to the individual, clothing, or a backpack/waistpack. The portable container contains one or more autoinjectors with one or more dosages of a drug or medication. If multiple autoinjectors are carried, they may each contain a different medication or antitoxin. The portable container includes an active temperature control that automatically adjusts drug or medication temperature based on one or more pre-programmed temperature thresholds.
  • Referring now to FIG. 1, an illustration of a first view 100 of the temperature-controlled portable container in accordance with embodiments of the present invention is shown. The temperature-controlled portable container is generally disposed oriented lengthwise along an axis. A main body 104 serves as a rigid outer container, and protects the inner components from environmental and physical damage. The main body 104 in one embodiment is constructed from an impact-resistant non-thermally conductive material such as ABS plastic, fiberglass, or carbon fiber. In other embodiments, the main body 104 is constructed from a thermally conductive material such as aluminum or steel. Although not shown in FIG. 1, the main body 104 in some embodiments has an eyelet or other attachment point for a lanyard or rope/string. A lanyard or rope/string allows the temperature-controlled portable container to be worn around the neck of a user or attached by rope/string to another portable assembly such as a golf bag or backpack. In other embodiments, the main body 104 is fixedly attached to a clip or other retaining mechanism that allows the temperature-controlled portable container to be attached to a shirt pocket or similar available location.
  • The temperature-controlled portable container has a lid 108, which retains the drug or medication within the main body 104. In a preferred embodiment, the lid 108 provides tool-free access to the drug or medication, and is screwed or clipped on and off by the user. A finger grip, as shown in FIGS. 1 and 2, may be provided to aid in easy attachment. Alternatively, a rough or knurled surface treatment on the side of the lid 108 may be provided for the same purpose. Tool-free access has the advantage of providing easy and fast access to the drug or medication, which a user may potentially need to access within seconds. In a second embodiment, the lid 108 requires a tool to attach or remove the lid 108 to the main body 104, such as a screwdriver. In a third embodiment, the lid 108 is locked to the main body 104, and requires a key or combination to remove the lid 108. The third embodiment may be of value if the drug or medication does not require instant access and a level of security is required to limit access to the drug or medicine. The lid 108 in one embodiment is constructed of the same material as the main body 104. In an alternate embodiment, the lid 108 is constructed of a different material as the main body 104.
  • The temperature-controlled portable container also includes a heat sink 112. The heat sink 112 is a heat exchanger between ambient air outside the main body 104 and the vessel that holds the drug or medication within the temperature-controlled portable container. In one embodiment, the heat sink 112 is constructed of the same thermally-conductive material as the main body 104, and in a second embodiment the heat sink 112 is part of the main body 104.
  • Although not required for all embodiments, in some embodiments the temperature-controlled portable container includes a display 116. In some embodiments, the display 116 is a liquid crystal display (LCD). In other embodiments, the display 116 is one or more light-emitting diodes (LEDs). In some embodiments, the display 116 is sunlight readable.
  • The display is used to communicate one or more status items to a user. The status items include an upper temperature threshold, which is the upper safe storage limit for the drug or medication contained within the temperature-controlled portable container. The status items include a lower temperature threshold, which is the lower safe storage limit for the drug or medication contained within the temperature-controlled portable container. The status items include the charge status for a portable power source within the temperature-controlled portable container. The charge status includes the percent fully charged, or the time remaining for the portable power source to continue to maintain the drug or medication between specified temperature limits. The status items include the current temperature of the vessel containing the drug or medication, or the ambient temperature. In addition to the status items described herein, the display 116 may also display selection menus or other status items.
  • Referring now to FIG. 2, an illustration of a second view 200 of the temperature-controlled portable container in accordance with embodiments of the present invention is shown. The second view 200 of the temperature-controlled portable container illustrates the same elements shown and described in FIG. 1. In addition the second view 200 includes a communication port 204. In some embodiments, a communication port 204 is not provided, and the temperature-controlled portable container has fixed and unmodifiable functionality. In other embodiments. the communication port 204 provides communication between an external computer, PDA, or cell phone and a processor within the temperature-controlled portable container. The external computer, PDA, or cell phone allows the user or operator to change, reprogram, or verify operating parameters of the temperature-controlled portable container or run diagnostics. In some embodiments, the communication port 204 provides a means to recharge the portable power source within the temperature-controlled portable container. In other embodiments, the communication port 204 provides a mean to power the temperature-controlled portable container from an external power source. In such a case, the connected external power source prevents the portable power source within the temperature-controlled portable container from discharging, such as when being transported on an aircraft, train, or automobile. In some embodiments, a connector separate from the communication port 204 is used to power the temperature-controlled portable container or recharge the portable power source. The communication port 204 in a preferred embodiment is a USB port, although other interfaces such as fire wire or RS-232 may alternatively be used.
  • Referring now to FIG. 3, a top view 300 of internal and external components of the temperature-controlled portable container in accordance with embodiments of the present invention is shown. The top view 300 omits the main body 104 in order to show internal components of the temperature-controlled portable container. Section lines B-B are provided in FIG. 3, and refer to the section B-B illustration of FIG. 6. From FIGS. 1 and 2, Lid 108, heat sink 112, display 116, and communication port 204 are illustrated.
  • The temperature-controlled portable container has an inner housing 304, which provides the inner container or storage vessel for the drug or medication. The inner housing 304 is constructed from a thermally conductive material, and in a preferred embodiment is Aluminum. The inner housing 304 is arranged lengthwise within the main body 104. In one embodiment, the inner housing 304 is open at the end where the lid 108 is attached, and is sealed at the opposite end. In a second embodiment, inner housing 304 is open at both ends, and a lower thermal conductor 404 is coupled to the end opposite the lid 108.
  • In a preferred embodiment, the drug or medication is contained within an epinephrine autoinjector (or Epi pen), Anapen, or Twinject. An Epi pen is a medical device used to deliver a measured dose (or doses) of epinephrine, also known as adrenaline, using autoinjector technology. Epi pens are most frequently for the treatment of acute allergic reactions to avoid or treat the onset of anaphylactic shock. The devices contain a spring-loaded needle that exits the tip of the device (in some cases through a sterile membrane) and into the recipient's body to deliver the medication. Epinephrine autoinjectors contain a pre-determined dose of epinephrine, usually between 0.3 mg and 0.5 mg of active ingredient at a concentration of 1:1000. Manufacturers have also made pediatric dosed versions available at 0.15 mg of active ingredient, and there is also a version which contains two individual doses (in case a repeated application is required) sold under the trade name Twinject. An injector includes any such device that an individual may administer to himself or another, including autoinjectors, Epi pens, Anapens, or Twinjects.
  • The temperature-controlled portable container has a centering ring 308. The centering ring 308 locates the inner housing 304 within the rear part of the main body 104. The centering ring 308 is preferably constructed of a thermally insulating material, and assists in thermal isolation of the inner housing 304 from main body 104.
  • The temperature-controlled portable container has a front bushing 312. The front bushing 312 locates the inner housing 304 within the front part of the main body 104, and in one embodiment provides the attachment point for the lid 108. The front bushing 312 is preferably constructed of a thermally insulating material, and assists in thermal isolation of the inner housing 304 from the main body 104 and lid 108.
  • An electronics assembly 344 is contained within the temperature-controlled portable container. The electronic assembly 344 includes a processor, memory, and other components supporting the portable power source, and is described in more detail with respect to FIG. 7. In one embodiment, the components of the electronics assembly 344 are mounted on a printed circuit board, or PCB.
  • Also shown in FIG. 3 are wedge 328, thermoelectric element wires 332, solenoid 336, and solenoid actuator 340. The function of these elements is described in more detail with respect to FIGS. 4, 5, 7, and 8.
  • Referring now to FIG. 4, a first side view 400 of internal and external components of the temperature-controlled portable container in accordance with embodiments of the present invention is shown. The first side view 400 omits the main body 104 in order to show internal components of the temperature-controlled portable container. In addition to the components previously shown and described with reference to FIGS. 1-3, FIG. 4 illustrates additional components.
  • The temperature-controlled portable container includes a lower thermal conductor 404. The lower thermal conductor 404 is coupled directly to the inner housing 304, and is constructed of a thermally conductive material such as Aluminum. In one embodiment, the lower thermal conductor 404 is part of the inner housing 304. The lower thermal conductor 404 conducts thermal energy between the inner housing 304 and a wedge 328, when the wedge 328 is engaged with the lower thermal conductor 404 and an upper thermal conductor 408.
  • The temperature-controlled portable container includes an upper thermal conductor 408. The upper thermal conductor 408 is coupled directly to a thermoelectric element 412, and is constructed of a thermally conductive material such as Aluminum. The upper thermal conductor 408 conducts thermal energy between the thermoelectric element 412 and the wedge 328, when the wedge 328 is engaged with the lower thermal conductor 404 and the upper thermal conductor 408.
  • The temperature-controlled portable container includes a thermoelectric element 412. In a preferred embodiment, the thermoelectric element 412 is a Peltier device. A Peltier device is a solid-state active heat pump which transfers heat from one side of the device to the other side against the temperature gradient (from cold to hot), with consumption of electrical power from the portable power source. A Peltier device may be desirable when a single device is to be used for both heating and cooling. When biased in a first manner, a first side cools while a second side warms. When biased in a second manner, the second side warms while the first side cools. The effectiveness of the pump at moving the heat away from the cold side is dependent upon the amount of current provided and how well the heat can be removed from the hot side. Thermoelectric element wires 332 provide means for the electronics assembly 344 to control the operation of the thermoelectric element 412.
  • A solenoid 336 is coupled to a solenoid actuator 340, which in turn is coupled to the wedge 328. The solenoid 336 controls the position of the wedge 328, by extending the wedge 328 when the solenoid 336 is activated, and retracting the wedge 328 when the solenoid 336 is deactivated. When the solenoid 336 is activated, the wedge 328 makes direct contact with the lower thermal conductor 404 and the upper thermal conductor 408. This, in turn, allows thermal conduction between the heat sink 112, the thermoelectric element 412, the upper thermal conductor 408, the lower thermal conductor 404, and the inner housing 304. FIG. 4 illustrates the wedge 328 position when the solenoid 336 is activated.
  • Referring now to FIG. 5, a second side view 500 of internal and external components of the temperature-controlled portable container in accordance with embodiments of the present invention is shown. The second side view 500 omits the main body 104 in order to show internal components of the temperature-controlled portable container.
  • FIG. 5 is similar to FIG. 4, but illustrates the wedge 328 position when the solenoid 336 is deactivated. When the solenoid 336 is deactivated, the wedge 328 is removed from direct contact with the lower thermal conductor 404 and the upper thermal conductor 408. This, in turn, prevents thermal conduction between the heat sink 112 and the thermoelectric element 412, and the upper thermal conductor 408, lower thermal conductor 404, and the inner housing 304. FIG. 5 illustrates the wedge 328 position when the solenoid 336 is deactivated.
  • Referring now to FIG. 6, a side cutaway view 600 of internal and external components of the temperature-controlled portable container in accordance with embodiments of the present invention is shown.
  • FIG. 6 follows section B-B of FIG. 3, in order to provide additional detail 600 of the temperature-controlled portable container. All of the components shown in FIGS. 1-5 are present in FIG. 6.
  • An Epi Pen 604 is placed within the inner housing 304 for temperature controlled transportation. An air gap 608 is between the Epi Pen 604 and the inner housing 304. The temperature-controlled portable container also includes an air gap 608 between the inner housing 304 and the main body 104.
  • Referring now to FIG. 7, a block diagram 700 illustrating electrical components of an embodiment of the temperature-controlled portable container of the present invention is shown.
  • The electrical components include a processor 704, which controls the operation of the thermoelectric element 412, solenoid 336, audible transducer 732, display 116, and communication port 204. The processor 704 receives input from one or more temperature sensors 720, pushbuttons 724, and the communication port 204. The processor 704 is a low-power, highly integrated microprocessor or microcontroller such as a microprocessor from the ARM Ltd. family of embedded microprocessors. Such microprocessors have integrated I/O ports, analog-to-digital converters, and other features that allow integration into small and miniature devices similar to the temperature-controlled portable container.
  • Processor 704 communicates with memory 708, which includes volatile memory and non-volatile memory. Memory 708 includes at least a first predetermined temperature 712, but may additionally include a second predetermined temperature 716. In one embodiment, at least part of memory 708 is integrated into processor 704.
  • In one embodiment, the first predetermined temperature 712 and second predetermined temperature 716 are programmed into memory 708 during a manufacturing process for the temperature-controlled portable container. In a second embodiment, pushbuttons 724 allow a user or operator to navigate menus on the display 116 to change operating parameters of the temperature-controlled portable container, including the first 712 and second 716 predetermined temperatures. In a third embodiment, a computer, PDA, or cell phone attached to communication port 204 allow a user or operator to navigate menus on the display 116 to change operating parameters of the temperature-controlled portable container, including the first 712 and second 716 predetermined temperatures.
  • Power for the processor 704, memory 708, display 116, solenoid 336, and thermoelectric element 412 is provided by portable power source 728. Portable power source 728 may in some embodiments include a rechargeable power device such as one or more batteries or capacitors. When a rechargeable power device or devices are used in the portable power source 728, a charging circuit is also present in portable power source 728. Portable power source 728 receives external power 736 in order to recharge the rechargeable power device or devices and in some embodiments external power 736 powers the entire temperature-controlled portable container when external power 736 is present. In some embodiments, communication port 204 is both a communication port 204 and a connector for external power 736. A USB port provides the functionality of a combined communication port 204 and external power source 736.
  • In a second embodiment, portable power source 728 is one or more replaceable batteries, such as batteries using alkaline technologies. In a third embodiment, the portable power source 728 is a rechargeable battery or capacitor and one or more solar cells recharge the battery or capacitor. In a fourth embodiment, the portable power source 728 is a rechargeable battery or capacitor and a motion/vibration-to-energy device recharges the battery or capacitor. In a fifth embodiment, no battery or capacitor for energy storage is present, and a renewable power source provides power to the temperature-controlled portable container. Power sources such as solar cells or motion/vibration-to-energy devices are renewable power sources.
  • In some embodiments, an audible transducer 732 is present in the temperature-controlled portable container. The audible transducer 732 produces predetermined tones, based on specific conditions detected by the processor 704. For example, one type of tone is produced when the portable power source 728 is just about to run out of power. A second type of tone is produced when a predetermined amount of time is left for the portable power source 728 to maintain the Epi Pen 604 between the first 712 and second 716 predetermined temperatures. A third type of tone is produced when external power 736 is supplied to the portable power source 728 and the portable power source is being recharged. A fourth type of tone is produced when a diagnostics failure occurs. A fifth type of tone is produced when a failure is detected with the solenoid 336, thermoelectric element 412, temperature sensor 720, communication port 204, display 116, pushbuttons 724, or memory 708.
  • The processor 704 periodically reads a temperature sensor 720 coupled to the inner housing 304. The inner housing 304 temperature approximates the Epi Pen 604 temperature, which in turn approximates the drug or medication temperature inside the Epi Pen 604. Depending on the thermal efficiency of the design employed, different temperature derating factors are applied to the inner housing 304 temperature in order to determine with accuracy the temperature of the drug or medication. In some embodiments, the temperature-controlled portable container includes more than one temperature sensor 720. Additional temperature sensors may provide inputs from the heat sink 112 (ambient air), thermoelectric element 412, or the main body 104.
  • In response to reading temperature sensors 720, the processor 704 controls the thermoelectric element 412 and solenoid 336 to manage thermal conduction as shown and described with reference to FIG. 8.
  • Referring now to FIG. 8, a flowchart illustrating steps of active temperature control in accordance with the present invention is shown. Flow begins at block 804.
  • At block 804, the portable device powers-up, or is manually reset. Power up includes initial portable power source 728 installation and activation or replacing the portable power source 728. Manual reset is any user-initiated operation to reset the temperature-controlled portable container, including through pushbuttons 724 or through a command transmitted through communication port 204 from a computer, PDA, or cell phone. Flow proceeds to block 808.
  • At block 808, a timer in the processor 704 expires. The timer determines the sampling frequency of the temperature sensors 720 by the processor 704. In one embodiment, the timer expires every minute. In a second embodiment, the timer expires every five minutes. In other embodiments the timer expires at a different time period than one minute or five minutes. In all embodiments, the timer is automatically restarted when it expires. Flow proceeds to block 812.
  • At block 812, the processor 704 reads the temperature sensors 720. Flow proceeds to decision block 816.
  • At decision block 816, the processor 704 determines if the temperature read from the temperature sensors 720 is above the first predetermined value 712. The first predetermined value, or temperature 712, is the low-limit, below which the drug or medication will deteriorate or become ineffective. If the temperature read from the temperature sensors 720 is above the first predetermined value 712, then relative to the first predetermined temperature 712 the temperature is acceptable and flow proceeds to decision block 820. If the temperature read from the temperature sensors 720 is not above the first predetermined value 712, then relative to the first predetermined temperature 712 the temperature is not acceptable and flow proceeds to block 828.
  • At decision block 820, the processor 704 determines if the temperature read from the temperature sensors 720 is below the second predetermined value 716. The second predetermined value, or temperature 716, is the high-limit, above which the drug or medication will deteriorate or become ineffective. If the temperature read from the temperature sensors 720 is below the second predetermined value 716, then relative to the second predetermined temperature 716 the temperature is acceptable and flow proceeds to block 824. If the temperature read from the temperature sensors 720 is not below the second predetermined value 716, then relative to the second predetermined temperature 716 the temperature is not acceptable and flow proceeds to block 832.
  • At block 824, the processor 704 de-energizes the solenoid 336. This causes the solenoid 336 to retract from the upper thermal conductor 408 and the lower thermal conductor 404, which prevents thermal conduction between the Epi pen 604 and the heat sink 412, as shown in FIG. 5 b. Without thermal conduction, the Epi pen 604 will tend to have the same temperature as ambient temperature. Flow proceeds to block 808 to wait for the timer to expire.
  • At block 828, the processor 704 configures the thermoelectric element 412 to conduct thermal energy from the outer container (main body 104) to the inner container (inner housing 304). Block 828 applies when the Epi pen 604 is too cold, or below the first predetermined temperature 712. Therefore, the thermoelectric element 412 is configured in such a way to cause the “hot” side to face the heat sink 112, and the “cold” side to face the upper thermal conductor 408. Flow proceeds to block 836.
  • At block 832, the processor 704 configures the thermoelectric element 412 to conduct thermal energy from the inner container (inner housing 304) to the outer container (main body 104). Block 832 applies when the Epi pen 604 is too warm, or above the second predetermined temperature 716. Therefore, the thermoelectric element 412 is configured in such a way to cause the “cold” side to face the heat sink 112, and the “hot” side to face the upper thermal conductor 408. Flow proceeds to block 836.
  • At block 836, the processor 704 energizes the solenoid 336. This causes the solenoid 336 to make contact with the upper thermal conductor 408 and the lower thermal conductor 404, which allows thermal conduction between the Epi pen 604 and the heat sink 412, as shown in FIG. 5 a. With thermal conduction, the Epi pen 604 will either increase in temperature (if flow was from block 828) or decrease in temperature (if flow was from block 832). Flow proceeds to block 808 to wait for the timer to expire.
  • It should be noted that some drugs or medications may only require a single temperature threshold, and as long as the current temperature is below that threshold, the drug or medication is usable.
  • Finally, those skilled in the art should appreciate that they can readily use the disclosed conception and specific embodiments as a basis for designing or modifying other structures for carrying out the same purposes of the present invention without departing from the spirit and scope of the invention as defined by the appended claims.

Claims (20)

1. A temperature-controlled portable container for carrying an injector, comprising:
an outer container;
an inner container, disposed within the outer container, wherein the injector is stored within the inner container, wherein the inner container is constructed of a thermally conductive material;
a temperature control device, wherein the temperature control device maintains an inner container temperature above a first predetermined temperature and below a second predetermined temperature, wherein the second predetermined temperature is higher than the first predetermined temperature;
a processor subsystem; and
a portable power source, coupled to the temperature control device and the processor subsystem, wherein the portable power source provides power to the temperature control device and the processor subsystem.
2. The temperature-controlled portable container of claim 1, wherein the outer container comprises:
a main body, disposed lengthwise, wherein the main body has a first end and a second end, wherein the main body is thermally insulated from the inner container;
a cap, wherein the cap attaches to the first end of the main body, wherein the cap retains the injector in the inner container when the cap is attached to the main body; and
a heat exchanger, fixedly attached to the second end of the main body, wherein the heat exchanger provides thermal conduction between ambient air and the temperature control device.
3. The temperature-controlled portable container of claim 2, the temperature control device comprising:
a thermoelectric element,
wherein the thermoelectric element conveys thermal energy from the inner container to the outer container when the inner container is above the second predetermined temperature, wherein the thermoelectric element conveys thermal energy from the outer container to the inner container when the inner container is below the first predetermined temperature.
4. The temperature-controlled portable container of claim 3, the temperature control device further comprising:
a solenoid, wherein the processor subsystem is coupled to the solenoid;
a thermally conductive plug, wherein the thermally conductive plug is mechanically coupled to the solenoid; and
wherein the thermally conductive plug provides thermal conduction between the inner container and the thermoelectric element when the solenoid is activated, wherein the thermally conductive plug does not provide thermal conduction between the inner container and the thermoelectric element when the solenoid is inactivated, wherein the processor subsystem activates the solenoid when the inner container temperature is below the first predetermined temperature or above the second predetermined temperature, wherein the processor subsystem inactivates the solenoid when the inner container temperature is above the first predetermined temperature and below the second predetermined temperature.
5. The temperature-controlled portable container of claim 4, wherein the processor subsystem comprises:
a processor;
a memory, coupled to the processor, wherein the first and second predetermined temperatures are stored in the memory; and
a temperature sensor, coupled to the processor and the inner container, wherein the temperature sensor measures the temperature of the inner container.
6. The temperature-controlled portable container of claim 5, the outer container further comprising:
a display, coupled to the processor, wherein the display provides visual indication to an operator of at least one of ambient air temperature, inner container temperature, portable power source level, and time remaining to maintain the inner container above the first predetermined temperature and below the second predetermined temperature based on the portable power source level, wherein the portable power source provides power to the display.
7. The temperature-controlled portable container of claim 6, the outer container further comprising:
a plurality of pushbuttons, coupled to the processor, wherein a user changes at least one of the first predetermined temperature and the second predetermined temperature with the plurality of pushbuttons.
8. The temperature-controlled portable container of claim 1, wherein the portable power source comprises:
a power generator, wherein the power generator generates power when the temperature-controlled portable container is in contact with an operator; and
a power distribution circuit, coupled to the power generator, wherein the power distribution circuit provides power to the processor subsystem and the temperature control device from the power generator.
9. The temperature-controlled portable container of claim 1, wherein the portable power source comprises:
a renewable energy source; and
a power distribution circuit, coupled to the renewable energy source, wherein the power distribution circuit provides power to the temperature-controlled portable container from the renewable energy source.
10. The temperature-controlled portable container of claim 1, wherein the portable power source comprises:
a battery; and
a power distribution circuit, coupled to the battery, wherein the power distribution circuit provides power to the temperature-controlled portable container from the battery.
11. The temperature-controlled portable container of claim 10, wherein the battery is rechargeable and the portable power source further comprises:
a battery charging circuit, coupled to the battery and the power distribution circuit; and
a connector, coupled to the battery charging circuit,
wherein a power source external to the outer container plugs into the connector, wherein the battery charging circuit recharges the battery and provides power to the power distribution circuit from the external power source when the external power source is plugged into the connector, wherein the battery charging circuit provides power from the battery to the power distribution circuit when the external power source is not plugged into the connector.
12. A method for maintaining an injector temperature in a temperature-controlled portable container, comprising:
measuring a temperature of an inner container, wherein the inner container is disposed within an outer container of the temperature-controlled portable container;
in response to measuring the temperature of the inner container:
if the temperature of the inner container is below a first predetermined temperature, then conveying thermal energy from an outer container of the temperature-controlled portable container to the inner container;
if the temperature of the inner container is above the first predetermined temperature and below a second predetermined temperature, then not conveying thermal energy between the outer container and the inner container, wherein the first predetermined temperature is below the second predetermined temperature; and
if the temperature of the inner container is above the second predetermined temperature, then conveying thermal energy from the inner container to the outer container.
13. The method of claim 12, wherein measuring the temperature of the inner container comprises a processor subsystem reading a temperature sensor affixed to the inner container, wherein the processor subsystem is coupled to the temperature sensor.
14. The method of claim 13, wherein conveying thermal energy comprises:
biasing a thermoelectric element by the processor subsystem, wherein the thermoelectric element is electrically coupled to the processor subsystem and mechanically coupled to the outer container;
activating a solenoid by the processor subsystem, to move a thermally conductive plug into a position to conduct thermal energy between the inner container and the thermoelectric element.
15. The method of claim 13, wherein the processor subsystem comprises:
a processor;
a memory, coupled to the processor, wherein the first and second predetermined temperatures are stored in the memory; and
a display, coupled to the processor, wherein the display provides visual indication to an operator of at least one of ambient air temperature, inner container temperature, portable power source level, and time remaining to maintain the inner container above the first predetermined temperature and below the second predetermined temperature.
16. The method of claim 15, the processor subsystem further comprising:
a plurality of pushbuttons, wherein a user changes at least one of the first predetermined temperature and the second predetermined temperature with the plurality of pushbuttons.
17. The method of claim 16, wherein a portable power source within the temperature-controlled portable container provides power to the processor subsystem, the solenoid, and the thermoelectric element.
18. The method of claim 17, wherein the portable power source is a rechargeable battery, and the portable power source further comprises:
a battery charging circuit, coupled to the battery; and
a connector, coupled to the battery charging circuit,
wherein a power source external to the outer container plugs into the connector, wherein the battery charging circuit recharges the battery and provides power to the temperature-controlled portable container from the external power source when the external power source is plugged into the connector, wherein the battery charging circuit provides power from the battery to the temperature-controlled portable container when the external power source is not plugged into the connector.
19. The method of claim 17, wherein the portable power source is a power generator, wherein the power generator generates power when the temperature-controlled portable container is in contact with an operator.
20. A temperature-controlled portable container for carrying an injector, comprising:
an outer container;
an inner container, disposed within the outer container, wherein the injector is stored within the inner container, wherein the inner container is constructed of a thermally conductive material;
a temperature control device, wherein the temperature control device maintains an inner container temperature below a predetermined temperature;
a processor subsystem; and
a portable power source, coupled to the temperature control device and the processor subsystem, wherein the portable power source provides power to the temperature control device and the processor subsystem,
wherein the processor subsystem measures the inner container temperature, and in response to measuring the inner container temperature:
the processor subsystem enables the temperature control device to conduct thermal energy from the inner container to the outer container if the inner container temperature is above the predetermined temperature, and
the processor subsystem prevents the temperature control device from conducting thermal energy between the inner container to the outer container if the inner container temperature is below the predetermined temperature.
US12/899,547 2009-10-08 2010-10-07 Portable medical container with active temperature control Abandoned US20110083445A1 (en)

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Effective date: 20101005

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