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WO2010096061A1 - Contenant intelligent de manchon pour utilisation dans un système de seringue commandé - Google Patents

Contenant intelligent de manchon pour utilisation dans un système de seringue commandé Download PDF

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Publication number
WO2010096061A1
WO2010096061A1 PCT/US2009/034825 US2009034825W WO2010096061A1 WO 2010096061 A1 WO2010096061 A1 WO 2010096061A1 US 2009034825 W US2009034825 W US 2009034825W WO 2010096061 A1 WO2010096061 A1 WO 2010096061A1
Authority
WO
WIPO (PCT)
Prior art keywords
vial
sleeve
memory
medication
memory sleeve
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.)
Ceased
Application number
PCT/US2009/034825
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English (en)
Other versions
WO2010096061A8 (fr
Inventor
Lance T. Parker
Reed J. Killion
Theresa W. Fossum
Douglas Smith
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.)
Texas A&M University System
Animal Innovations Inc
Texas A&M University
Original Assignee
Texas A&M University System
Animal Innovations Inc
Texas A&M University
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Filing date
Publication date
Application filed by Texas A&M University System, Animal Innovations Inc, Texas A&M University filed Critical Texas A&M University System
Priority to PCT/US2009/034825 priority Critical patent/WO2010096061A1/fr
Publication of WO2010096061A1 publication Critical patent/WO2010096061A1/fr
Publication of WO2010096061A8 publication Critical patent/WO2010096061A8/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61D—VETERINARY INSTRUMENTS, IMPLEMENTS, TOOLS, OR METHODS
    • A61D7/00—Devices or methods for introducing solid, liquid, or gaseous remedies or other materials into or onto the bodies of animals
    • 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
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • 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
    • A61M5/50—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 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5086—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 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile for indicating if defective, used, tampered with or unsterile
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/16—Holders for containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/70—Device provided with specific sensor or indicating means
    • A61J2200/76—Device provided with specific sensor or indicating means for fluid level
    • 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
    • A61M2205/27—General characteristics of the apparatus preventing use
    • 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
    • A61M2205/27—General characteristics of the apparatus preventing use
    • A61M2205/273—General characteristics of the apparatus preventing use preventing reuse, e.g. of disposables
    • 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
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3368—Temperature
    • 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
    • A61M2205/35—Communication
    • A61M2205/3546—Range
    • A61M2205/3569—Range sublocal, e.g. between console and disposable
    • 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
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3592—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission
    • 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
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • 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
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6018—General characteristics of the apparatus with identification means providing set-up signals for the apparatus configuration
    • 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
    • A61M2205/70—General characteristics of the apparatus with testing or calibration facilities
    • 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
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31525—Dosing

Definitions

  • the present invention relates generally to storage systems for medications for delivery and use in a field application.
  • U.S. patent number 7,056,307 (the '"307 patent”), which is incorporated herein by reference in its entirety.
  • This system discloses a highly accurate pump, reservoir bottle and syringe, where the pump delivers precise dosages of fluid medication from the reservoir bottle to the syringe for delivery.
  • a system computer determines the dosage to be injected to a given animal (generally determined by animal weight, medical history, medication records, and other pertinent information), and instructs the pump controller (which can be a computer) to dispense the calculated amount of fluid.
  • the pump then dispenses the proper amount of fluid (possibly in several doses, under the control of the system computer) to the syringe for injection into the animal by an operator or technician.
  • the '307 system or a comparable dosage controlled injection system provides for ready administration of medications in accurate amounts and time-stamping the administration of the dose.
  • Much of the equipment in the '307 system can be housed in an easily transportable portable carrier, such as a backpack or belt mounted holster system for use in the field, such as a feedlot in the pastures.
  • the system computer interfaces the field deployed equipment by wireless communication from a wireless device associated with the field components. In this fashion, animal data
  • the system computer could be located in the transportable carrier if the needed animal data was stored in memory accessible by the system computer, for instance, needed animal data could be retrieved from data storage in the system computer or from data storage located on the animal itself, such as stored in an RFID tag located on the animal.
  • Other aspects of the controlled injection system include a sensor for monitoring the status of the syringe (U.S. provisional application number 61039158, hereby incorporated by reference) and improved spool valve for filling the syringe, as disclosed in U.S. provisional application number 61038351, also incorporated by reference).
  • a portable battery operated or mechanical scale can be incorporated in the '307 system, with the system receiving the weight either electronically or from manual operator input.
  • a scale is generally available and can be incorporated into the controlled injection system (i.e. communicate with the host computer, either manual input or electronic input).
  • One embodiment of the invention includes a memory containing sleeve that is associated with a medication vial or bottle.
  • the memory sleeve stores relevant information concerning the medication and can communicate with a computer system to transmit the stored information, and, in certain embodiments, the stored information may be updated.
  • Stored information can comprise medicine identification, security status, temperature status, volume available, date first used, or any other desired characteristic.
  • the memory sleeve may be a ring-shaped, electronically active system that fits over the lip of the medication source vial and grips the narrower neck of the vial when properly seated and locked in position.
  • This sleeve may incorporate a wireless communications device and a non-volatile memory storage device, as well as means (either direct or indirect) for determining the amount of medication being used or remaining.
  • An appropriate socket for direct, wired communication e.g.,
  • USB, serial, and/or the like may optionally be included in the sleeve for communication with onboard components.
  • the memory sleeve may include a screen for input/output purposes, such as a screen on a calculator driven by battery or solar powered, or a touch screen for direct input.
  • the invention includes an insulating jacket or sleeve for the medicine reservoir, providing thermal stability for the contained fluids as well as protection from light energy degradation.
  • the two sleeves in combination are included in the scope of the invention.
  • Figure 1 includes two notional combinations of Memory Sleeve, medication source vial, and a Temperature Sleeve, where
  • Figure Ia illustrates an exploded view of an embodiment of three components taught in the present invention.
  • Figure Ib illustrates an embodiment of the three components ready for deployment.
  • Figure 2 illustrates variants of the Memory Sleeve component in relation to the medication source vial.
  • Figure 2a illustrates a Memory Sleeve that totally encompasses the lip of the source vial.
  • Figure 2b illustrates a Memory Sleeve that seals the Temperature Sleeve to improve the latter's temperature stabilization capabilities.
  • Figure 3 illustrates alternate embodiments of the present invention.
  • Figure 3a illustrates an alternate embodiment of the present invention.
  • Figure 3 b illustrates an embodiment of a locking architecture for the Memory Sleeve.
  • Figure 4 illustrates a system architecture relative to the Memory Sleeve's construction.
  • Figure 4a illustrates an embodiment of the present invention.
  • Figure 4b illustrates an alternate embodiment of the present invention.
  • Figure 4c illustrates an alternate embodiment of the present invention.
  • the present invention teaches the deployment of dual-sleeve structure that addresses thermal stability and monitoring of vial fluids. Either sleeve can be used alone or in combination with the other.
  • Figure 1 illustrates the basics of the present invention.
  • Figure Ia shows an exploded view of the two sleeves, 1001 and 1002, in relation to the medicine source vial 1003, which is also commonly referred to as a bottle, container, vial, reservoir, ampoule, or other recognized medicine storage and delivery system.
  • the source vial 1003 is shown with a conventional bottle neck and lip structure, and it can have an industry-standard protective cap and a hermetic membrane seal (such as a foil membrane seal) that can be pierced or punctured by a hollow needle, such as may be part of a hypodermic needle filling system.
  • a hermetic membrane seal such as a foil membrane seal
  • the insulating sleeve 1002 is shown as a cylinder that surrounds the vial.
  • the insulating sleeve provides temperature stabilization by providing thermal insulation within a relatively thin package.
  • the present invention incorporates thermal insulation technology developed by NanoPore
  • VIPs are made by sealing the thermal insulation in a barrier film under vacuum.
  • the barrier film (a polymer or metal film) is formed into a pouch which the panel insert is put inside before the unit is evacuated and heat sealed.
  • the sealed edges of the barrier film create a flap of film which extends out from the edges of the panel which can be folded and taped against the panel in use.
  • the VIP structure creates a three layer structure: an inside layer 1005 formed by a semi-pliable or pliable thin material, such as a polymer or metal film, a similar pliable material forming the outer layer 1006 that is opaque to radiation, including infrared radiation, to reduce radiant energy transfer from the medicine source, and an interstitial matrix 1004 of nanoporous material with ultra low thermal conductivity due to exploitation of the Knudsen Effect.
  • the inner and outer layers which encapsulate the inner nanoporous matrix can form a contiguous, continuous surface and may thus be identical. While the Nanopore VIP is preferred due to the long term temperature stability it provides, other common insulating materials could be used for sleeve construction, particularly where long term exposure is not anticipated.
  • the insulating sleeve covers a substantial portion of the vial exterior. As shown, a portion of the top exterior is left exposed for coupling of the memory sleeve. Heat loss through this area is reduced as liquid level, even in a full vial, should be below the top of the insulating layer. However, if needed, the insulating layer can cover the entire exterior surface of the vial.
  • the insulating sleeve in combination with a annular memory sleeve may cover substantially all of the exterior surface of the vial as shown in Figure 1.
  • the vial itself may be manufactured from a highly insulating material, thereby combining the vial and sleeve into a single device.
  • the Memory Sleeve is a highly insulating material.
  • the present invention embraces a memory sleeve 1001 that is to be affixed to the source vial, here shown as affixed to the upper portion of the source vial.
  • Figure Ib illustrates one possible form that the assembled system might take, wherein the memory sleeve 1001 is, in this example, affixed below the widened rim of the bottle neck at the distal end of the medicine source vial 1003.
  • the memory sleeve may be a semi-planar surface attached to the vial, such as glued to the bottom of the vial (either interior to the memory sleeve, exterior to the memory sleeve, or with a memory sleeve that lacks a bottom.
  • Figure 2 illustrates additional geometric variations on the design and deployment of the memory sleeve structure near the top portion of the vial, and illustrates that the sleeve need not be structured to fit around the narrowest portion of the bottle neck, but can be fabricated to lock onto the rim.
  • the inner diameter of the memory sleeve 2001 might be a pliable material, such as a semi-rigid polymer foam, shaped internally to provide maximum stability when forcibly placed over the source vial's rim as shown, the cavity inside the inner diameter of the annulus approximating the shape of the vial rim.
  • the actual location of the memory sleeve is not critical.
  • Figure 2b shows an alternate approach to configuration of the memory sleeve.
  • FIG. 2b also illustrates part of the larger system into which the present invention is to be integrated, namely, the hollow needle 2003 that will be inserted and attached via flexible cable to the high-precision viscosity-independent pump (not shown) that pumps medication out of the source vial 1003.
  • the hollow needle 2003 is intended to pass through the sealed membrane of the source vial to preserve sterility of the medicine, as has become standard practice in regard to medications delivered via injection for both animals and humans.
  • a vent needle would also be inserted into the sealed membrane to prevent vacuum lock when in use.
  • the two needles may be combined into a single needle structure.
  • the annular body of the memory sleeve 1001 (which may be fabricated from plastics, polymers, composites, or any environmentally suitable material in which the active components being herein described may be mounted and, if necessary, sealed from the outside world) is depicted as an undifferentiated solid, it is understood that it can be formed with cavities and mounting hardware and/or fastener anchor points as well as wiring or cabling between different possible components, as needed.
  • the memory device 3002 is shown inhabiting a suitably formed cavity inside the annulus into which the device is positioned so as to be able to withstand shock and vibration to the limits specified for the medication dispensing system.
  • Figure 3 provides details concerning the memory sleeve and potential component(s) within it that provides its intended functionality as an intelligent device.
  • Figure 3a shows a representative plan view of one possible configuration of components comprising an intelligent memory sleeve subsystem. Internal components that are embedded inside the intelligent sleeve are shown in dotted outline, while components visible and/or accessible from the outside world are shown in solid outlines. Components may be powered by battery power, or by induction (such as provided by magnetic coupling or inductive coupling power transfer, such as disclosed in U.S.
  • Memory element 3002 is the no n- volatile memory device.
  • Memory element may be contained in an RFID transponder or tag, such as available from
  • RFID chip model ME-Y2000 Series Maxell also supports a read/write platform for use with this chip which is contained on a printed-circuit board measuring only 50 * 60 mm and supports a variety of host interfaces, including USB, UART, and RS-232C standards.
  • Other low powered memory devices such as flash memory type devices, DRAM, low-
  • Power DDR SDRAM low-Power SDR SDRAM, on-chip SRAM, asynchronous and synchronous SRAM and PSRAM can be utilized.
  • Information may be placed in the memory sleeve at the pharmaceutical manufacturer's plant (where the vials are filled), or by communication with the host computer in an injection system (as later described).
  • the memory should be readable by the host computer controlling the injection system. Additional information that may be stored in the memory sleeve includes, but is not limited to: (1) the date and time, provided automatically by the host computer; (2) the date code of the medication; (3) the lot number of the medication; (4) the amount of medication contained in the source vial; (5) the name or ID of the medication; (6) the manufacturer of the medication (automatically provided by the software from its internal database if it is a brand name medication rather than a generic product); (7) identification of the technician assembling the sleeves and vials; (8) a security status; and (9) a temperature status.
  • Various other components may be included in the memory sleeve, such as a processor, wireless communication devices (including blue tooth communication or cell phone components).
  • Other components that may be included in the sleeve include a temperature sensor such as produced by Measurement Computing of Norton, MA whereby temperature logging can be used to monitor the temperature profile during transportation and storage of the vial.
  • the temperature sensor should be positioned on the exterior of the bottle, preferably between the insulating jacket and exterior bottle surface.
  • a temperature sensitive label such as Thermax label from Thermographic Measurements Ltd in Australia
  • the temperature label may be queried using a LED and light receptor to determine (based on the reflected light from the label) whether the temperature range has been violated.
  • the integrity circuit can simply be a circuit detecting resistance, voltage or current across a foil hermetic seal or a conductor embedded in the seal of the vial.
  • Other sensors can be combined with active RFID tags, including humidity, shock/vibration, light, radiation, and pressure sensors as needed.
  • a flow meter may be included in the sleeve to calculate fluid flows, but this is not preferred, as an ultrasonic flowmeter would be preferred (to avoid placing a meter within the vial itself) and current versions are power consumers.
  • the memory sleeve may also include an information display screen 3003 that is capable of displaying key information about the contents/status of the vial. Connections between any of the various components are not shown for the sake of simplifying the figure. Figure 4c shows many possible optional components that can be integrated within the memory sleeve.
  • Figure 4 provides block diagram level descriptions of the memory sleeve system as it relates to its active functionality, considered in isolation from the insulating sleeve.
  • Figure 4a shows one base architecture, at a block diagram level, of the wireless version of the memory sleeve system.
  • communication between the external hosting computer (the application-specific software that controls the automated medication injection system) and the memory sleeve's non-volatile memory device is mediated by the wireless communication means, such as blue tooth, magnetic coupling, radio frequency communications including RFID or cell phone components (represented in the earlier Figure 3a as element 3004).
  • the wireless communication means such as blue tooth, magnetic coupling, radio frequency communications including RFID or cell phone components
  • FIG. 4b Another architecture for the memory sleeve is illustrated in Figure 4b, where a direct connection between the external computer, or host computer, is made using one of several available industry-standard protocols, such as USB, serial connection, or other means of transmitting information in both directions via a physical cable inserted into the appropriate socket on the memory sleeve (represented in the earlier Figure 3a as element 3001). Wireless communication is preferred as a wired interface port may become contaminated in the field.
  • industry-standard protocols such as USB, serial connection, or other means of transmitting information in both directions via a physical cable inserted into the appropriate socket on the memory sleeve (represented in the earlier Figure 3a as element 3001).
  • Wireless communication is preferred as a wired interface port may become contaminated in the field.
  • the sleeve can incorporate both wired and wireless options (3001 and 3004 may be simultaneously present). It is understood that the physical location of such all components distributed within the sleeve shown in Figure 3a is notional only and merely representative of a workable architecture.
  • the chosen method to communicate with the host computer is considered a means to communicate, or a communication means.
  • the memory sleeve may be affixed to the vial in a number of fashions.
  • Figure 3b illustrates a clam shell hinged annular structure for the sleeve where two half annul i are joined by an integrated hinge 3007 (the sleeve material may be sufficiently flexible to avoid a mechanical hinge) and which can be locked onto the bottle neck of the source vial using an integrated lock system or mechanical joint 3006, or by gluing, heat sealing, RF sealing or other means of fixedly joining the two ends. If the ends are connected via a locking removably attaching element, the integrity of the lock can itself be monitored by the memory sleeve. For instance, the manufacturer, after filling and attaching the sleeve, and the authorization to re-set security status, can set the status of the sleeve as
  • the device for detecting the status of the sleeve can be a wire that is broken and must be replaced by the manufacturer to reset. This embodiment does not require polling, and can be checked upon use of the vial. If the sleeve is later removed or the lock "unlocked” this change in status can be detected and stored in memory. Re-locking or re-attaching the sleeve should not re-set the status to attached or locked unless the technician has the authority to re-set. Hence, the memory sleeve can inform a user if the sleeve/vial combination is suspect.
  • the active elements be contained in one half of the ann ⁇ lus to avoid internal flexible connections through the hinge.
  • the memory sleeve is permanently attached to the vial by pharmaceutical manufacturing facility where the vial is filled and the sleeve's memory can be populated with relevant data by the manufacturer.
  • the memory sleeve is intended to be a single use device, and discarded with the vial.
  • the memory sleeve and vial can be incorporated as the reservoir bottle in an computer controlled injection system such as that disclosed in the '307 patent.
  • an computer controlled system vial with memory sleeve, pump, syringe, computer to control pump, all operatively connected
  • the operator would identify the vial to be used in the system to the host computer (such as by wanding the vial for RFID communications) or by establishing communications between the host computer and memory sleeve.
  • Communications can be established by cable connections between the vial and computer (including Plug and Play type automatic recognition) or by inputting a vial ID into the host computer and having the host recognize the vial through wireless communications, or other methods (such as activating the vial (for instance, by allowing battery power to components) and having the host search for an active vial).
  • the host system can query the memory sleeve for relevant information stored in the sleeve memory (medication, integrity of vial, temperature constraints, age, etc) to insure that the proper medication is being selected and the efficacy of the medication.
  • the vial can be loaded into a suitable dispensing mechanism for incorporation into the injection system (e.g. the fluid lines must be attached to the vial).
  • the sleeve memory in conjunction with the host computer, can tract medication used from the vial, or medication remaining to be dispensed. This tracking can take several forms. For instance, the sleeve memory may only have the initial volume of medication stored in sleeve memory. In this event, the host computer would have to track usage against the initial volume (usage can be determined from the highly accurate system pump) to determine the amount remaining in the vial.
  • the amount remaining can be used to determine if a new vial needs to be loaded, or, if the vial will not be exhausted in a single setting, to store volume information with a vial ID in the host computer's memory for later use of the vial.
  • the host computer can send and store information on the vials fluids to the sleeve memory. For instance, after each dispensing of fluid, the host could store in sleeve memory the amount of fluid remaining in the vial (or the amount used). Note that the amount of fluid remaining in the vial must account for fluid in the lines - to account for line fluid, the system may have an initiation sequence where the lines are primed (by the pump) and the host computer tracks the volumes in the lines form the operation of the pump. Alternatively, the line volume may be a predetermined quantity, and the host computer can account for this known volume.
  • the injection system has a host computer and a highly accurate pump, that fluidly connects a syringe with a vial and the memory sleeve that communicates with the host computer - communication may be one way or two way.
  • a commonly employed memory in the sleeve is an RFID tag.
  • Each RPID device is considered to have non-volatile memory, although the memory may not be alterable by the host computer.
  • the RFID tag may only contain a vial identifier.
  • information on the fluid remaining in the vial can be tracked by the host system if the system database contained information on the vial's initial fluid volume.
  • the host computer can determine the state of the source vial at any time. While the data is no longer physically associated with the source vial, but rather is associated with the source vial "virtually" in respect to a database relation, the net result produces the remaining volume.
  • the Insulating sleeve In a field application, such as in a feedlot or pasture setting, the insulating sleeve is a valuable addition to the system.
  • An insulating sleeve may not be needed if the medication is not sensitive to temperature extremes, or in the event that the vials are stored in an insulated storage container or refrigerated (or heated) container and the injection system is connectable to the relevant storage device.
  • the vial or reservoir system allows for recognition of the "vial” (contents and status of contents for use in a controlled injection system. Recognition of the vial will reduce the possibility of operator error in administering the incorrect medication, as the host computer (or the screen on the vial or both ) can alert the operator of the error in vial ID, or that the vial is compromised (temperature, security status, or other monitored condition).
  • the intelligent vial vial with memory sleeve in conjunction with the controlled injection system, allows for accurate administration of effective medications to animals, such as cattle.
  • the memory sleeve is shown as a collar, but this is simply one embodiment. Other shapes are possible.
  • the device is intended to be used in a multi-dosage environment, and typically a vial will be in the preferred range of 250 cc and larger.
  • the memory sleeve is disposable, but it may be designed to be removable for a vial and re-used. In this event, the contents of the memory device would have to be reinitialized for a new use, so that the non-volatile memory device now contains information specific to the new vial of medicine with which the memory sleeve is now associated and to which it is physically attached.
  • Further enhancements of the various embodiments of the present invention include e (1) generalizing two-way communication between the memory sleeve and the generic system to be enhanced, (2) acquiring and communicating precise information about the usage of medicine being extracted from the source; and (3) the extraction and/or display of the remaining medicine and status of the medicine (e.g. temperature exceeded) within the source vial. It should be noted that the display of information could involve the actual integration of a small display screen as part of the Memory Sleeve architecture.
  • a memory sleeve is fitted first onto the mouth and neck of the vial, and then the vial is slipped, bottom-first, into a temperature sleeve.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Vascular Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Medical Informatics (AREA)
  • Primary Health Care (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Details Of Rigid Or Semi-Rigid Containers (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Divers modes de réalisation de la présente invention portent sur l'amélioration de la précision de dosage et de l'efficacité de systèmes calculant des doses de médicament pour une injection à des animaux et préparant la dose correcte dans un sous-système automatisé de seringue. Dans un mode de réalisation, on obtient l'amélioration par protection simultanée du médicament vis-à-vis de températures extérieures ambiantes dégradant normalement son efficacité, tout en surveillant avec précision la quantité de médicament restant à l'intérieur du tube-source afin d'empêcher un sous-dosage par inadvertance en raison d'un appauvrissement non détecté de la source. Ce système à double manchon (un pour la température, un pour la mémorisation de données relatives aux teneurs du tube-source) constitue un produit intelligent d'addition à une technologie d'injection automatisée présente et future utilisée pour maintenir le bétail sain.
PCT/US2009/034825 2009-02-23 2009-02-23 Contenant intelligent de manchon pour utilisation dans un système de seringue commandé Ceased WO2010096061A1 (fr)

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PCT/US2009/034825 WO2010096061A1 (fr) 2009-02-23 2009-02-23 Contenant intelligent de manchon pour utilisation dans un système de seringue commandé

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PCT/US2009/034825 WO2010096061A1 (fr) 2009-02-23 2009-02-23 Contenant intelligent de manchon pour utilisation dans un système de seringue commandé

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WO2012135315A1 (fr) * 2011-03-31 2012-10-04 Amgen Inc. Adaptateur de flacon et système
WO2012087906A3 (fr) * 2010-12-23 2012-10-26 Klindown, Llc Systèmes et procédés pour programmer sans fil une capsule de bouteille de prescription
EP2490957A4 (fr) * 2009-10-23 2015-04-01 Amgen Inc Adaptateur de fiole et système
EP3031486A1 (fr) 2014-12-09 2016-06-15 CONARIS research institute AG Cartouches de médicament pour dosage optimisé
CN109963543A (zh) * 2016-10-25 2019-07-02 沃特奥有限公司 带有条件指示和锁定机构的容器盖
US10704944B2 (en) 2014-09-14 2020-07-07 Becton, Dickinson And Company System and method for capturing dose information
US10971260B2 (en) 2014-09-14 2021-04-06 Becton, Dickinson And Company System and method for capturing dose information
CN115551410A (zh) * 2020-03-31 2022-12-30 普雷斯健康公司 体液采样装置及其使用方法

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Cited By (13)

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Publication number Priority date Publication date Assignee Title
US9662271B2 (en) 2009-10-23 2017-05-30 Amgen Inc. Vial adapter and system
EP2490957A4 (fr) * 2009-10-23 2015-04-01 Amgen Inc Adaptateur de fiole et système
WO2012087906A3 (fr) * 2010-12-23 2012-10-26 Klindown, Llc Systèmes et procédés pour programmer sans fil une capsule de bouteille de prescription
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US10704944B2 (en) 2014-09-14 2020-07-07 Becton, Dickinson And Company System and method for capturing dose information
US10971260B2 (en) 2014-09-14 2021-04-06 Becton, Dickinson And Company System and method for capturing dose information
US11988536B2 (en) 2014-09-14 2024-05-21 Becton, Dickinson And Company System and method for capturing dose information
EP3031486A1 (fr) 2014-12-09 2016-06-15 CONARIS research institute AG Cartouches de médicament pour dosage optimisé
CN109963543A (zh) * 2016-10-25 2019-07-02 沃特奥有限公司 带有条件指示和锁定机构的容器盖
EP3532007A4 (fr) * 2016-10-25 2020-07-15 Waterio Ltd Bouchon de récipient à indication conditionnelle et mécanisme de verrouillage
CN115551410A (zh) * 2020-03-31 2022-12-30 普雷斯健康公司 体液采样装置及其使用方法

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