EP2806821B1 - Device and system for tracing medicaments administered to an animal - Google Patents

Device and system for tracing medicaments administered to an animal Download PDF

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Publication number
EP2806821B1
EP2806821B1 EP13703340.3A EP13703340A EP2806821B1 EP 2806821 B1 EP2806821 B1 EP 2806821B1 EP 13703340 A EP13703340 A EP 13703340A EP 2806821 B1 EP2806821 B1 EP 2806821B1
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European Patent Office
Prior art keywords
administration
medicament
animal
cartridge
information
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German (de)
French (fr)
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EP2806821A2 (en
Inventor
Antoon Willem Johan CLAESSENS
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Piglets Treatment System BV
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Piglets Treatment System BV
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61DVETERINARY INSTRUMENTS, IMPLEMENTS, TOOLS, OR METHODS
    • A61D7/00Devices or methods for introducing solid, liquid, or gaseous remedies or other materials into or onto the bodies of animals

Definitions

  • the present invention pertains to a device and system for tracing medicaments administered to an animal.
  • the invention pertains to a device and system that may provide high integrity information with regard to the medicaments that an animal has received throughout its lifespan.
  • VTVS VAC-TRAC TM Verification System
  • JP2005160391 discloses an animal management system which enables traceability of medicinal agents administrated to an animal.
  • the system includes tags to be put on animals, a syringe to administrate the medicinal agents and remote processing means which are able to communicate with the syringe.
  • tags to be put on animals
  • remote processing means which are able to communicate with the syringe.
  • the right amount of medicinal agents to be delivered is enquired at the remote processing means.
  • the information is registered into a database.
  • an administration device comprising administration means for administering a medicament to an animal, the device having two modes, a default non-administration mode and an administration mode, the latter allowing administration of the medicament to the animal, a switching means to switch the device between the said modes, an establishing means to establish that the device is within a working distance of the animal to administer the medicament, the switching means and establishing means being operatively connected such that the switching means switches the device from the default mode to the administration mode after the establishing means has established that the device is within a working distance of the animal to administer the medicament, processing means that upon administration of the medicament automatically provide a data sending means to send information about the administration of the medicament to a data storage unit being connected to an animal, and the switching means to switch the device to the default non-administration mode.
  • a preferred embodiment is defined in the dependent claim.
  • This device makes use of existing technology of connecting data storage units to animals, for example as described in French patent application FR 2 898 011, published 7th of September 2007 ), the units (for example an EID/RFID present in an ear tag to provide a tamper-resistant electronic identification as well as a data storage possibility) storing data about actual administration of medicaments to the animal.
  • the storage of the data in the storage unit depends on an operator sending the data to the storage unit and thus is prone to the same disadvantages as known from other prior art techniques. It was applicant's recognition that the existing technology can be markedly improved when automatically storing information about the administration of the medicament in the data storage unit right after the actual administration. In order to accomplish this accurately, the actual administration with the device triggers the storing of the information.
  • the device may communicate directly with the storage unit at the moment of administration.
  • a default non-administration mode i.e. a mode wherein a medicament cannot be applied by using the normal administration tools of the device, typically a trigger or button.
  • the present invention is also embodied in a system for applying the above method wherein the system comprises a data storage unit connected to an animal, a device for administering a medicament to the animal, the device having two modes, a default non-administration mode and an administration mode, the latter allowing administration of the medicament to the animal, a switching means to switch the device between the said modes, an establishing means to establish that the device is within a working distance of the animal to administer the medicament, the switching means and establishing means being operatively connected such that the switching means switches the device from the default mode to the administration mode after the establishing means has established that the device is within a working distance of the animal to administer the medicament, and processing means that upon administration of the medicament automatically provide a data sending means to send information about the administration of the medicament to the animal to the data storage unit, and the switching means to switch the device to the default non-administration mode.
  • the invention thus pertains to an administration device for use in the method and system as described here-above, the device comprising administration means for administering a medicament to an animal, the device having two modes, a default non-administration mode and an administration mode, the latter allowing administration of the medicament to the animal, a switching means to switch the device between the said modes, an establishing means to establish that the device is within a working distance of the animal to administer the medicament, the switching means and establishing means being operatively connected such that the switching means switches the device from the default mode to the administration mode after the establishing means has established that the device is within a working distance of the animal to administer the medicament, and processing means that upon administration of the medicament automatically provide a data sending means to send information about the administration of the medicament to a data storage unit being connected to an animal, and the switching means to switch the device to the default non-administration mode.
  • Medicament any substance or composition of matter able to prevent, treat, ameliorate or cure a disease or disorder.
  • Typical medicaments used for live-stock are antibiotics, vaccines, anti-inflammatory agents, muscle-relaxants and other small molecule pharmaceuticals.
  • Data storage unit any unit that comprises means for storing data, such as an RFID chip, a magnetic chip or any other electronic memory, in particular for example an EEPROM, RAM, NVM or FLASH memory.
  • the unit may be comprises in an identification means typically used for identification of an animal such as an ear tag, implant, or bolus, or a combination of any of these.
  • Medicament identification information information enabling to assess the identity of the medicament including e.g. origin, content, date of manufacture, expiry date, volume to be administered.
  • a cartridge an, often disposable, container which holds a active ingredient to be applied by a device to which the cartridge can be operatively connected.
  • the device is brought in a position to administer the medicament, where-after an administration trigger is given by an operator of the device, the trigger automatically resulting in establishing whether the device has approached the animal sufficiently, and if so, in an automatic administration of the medicament.
  • the device is operated in a fashion that is common for any (semi-)automatic administration device such as for example the device as known from US 7,601,137 .
  • the device is simply brought in an administration position and then the trigger is pulled to actually accomplish administration of the medicament.
  • the present invention upon pulling the trigger, it is established immediately whether the device has approached the animal sufficiently, for example by using an optical or contact sensor on the device.
  • the devices than switches to the administration mode and administration of the medicament is automatically performed.
  • the time that lapses between the pulling of the trigger and the actual administration need not be more than a few milliseconds. This way, the operator does not experience any delay in the actual administration. If it is established upon pulling the trigger that the device has not approached the animal sufficiently, the device will not switch to an administration mode and the pulling of the trigger will not lead to an actual administration. This way, it can be prevented that a medicament leaves the administration device without being actually administered to an animal.
  • establishing that the device has approached the animal is performed by checking whether the device is within predetermined distance from the data storage unit.
  • use can be made of the fact that present day technology has advanced such that a typical data storage unit can be easily sensed wireless.
  • the actual administration can only take place when the data storage unit is within a predetermined distance of the device. This distance can be chosen such that the device is able to send data reliably to the data storage unit at the moment of (or right after) administration. This way, it can be virtually ensured, not only that actual administration can take place at the moment an operator triggers administration, but also, that data concerning this administration can be automatically stored in the data storage unit by sending these data from the device to the unit.
  • the device is provided with a means to establish a digital contact with the data storage unit when the device is within the predetermined distance, the contact allowing data to be exchanged between the storage unit and the device.
  • data cannot only be send from the device to the unit, but data can actually be exchanged by the device and the unit.
  • the device checks at the moment an operator triggers an administration operation with the device, what animal is bound to receive the medicament. This check can for example be used as an extra measure to assess whether the intended administration complies with the administration scheme for the animal. If not, this could lead to a block for the switch to the administration mode, even if the device has approached the animal sufficiently for enabling an actual administration operation.
  • the device stores this animal identification information together with the information about the administration of the medicament in a memory, the memory being present in the device or remote from the device.
  • the information package that is relevant for assessing i.a. food safety is not only stored in the data storage unit connected to the animal, but additionally in a memory non connected to the animal, either in the device itself or a remote memory such as a memory of a central server at the farmer's. This advantageously enables the use of this data for additional purposes that may even further address the concerns of the consumer about food safety, animal wellness and proper medicament use.
  • the data stored in the memory being present in the device or remote from the device is accessible by a second administration device with the purpose of checking compliance of a medicament administered by the first device to the animal, with a second medicament to be applied with the second device to the same animal.
  • the device after administration of the medicament to the animal, the device cannot be switched to the administration mode by approaching the same animal for a predetermined amount of time. This way it can be prevented for example that the same animal receives an unwanted second dose of the medicament or that it receives a dose of another medicament whereas this is not allowed after administration of the first medicament.
  • many labels of medicaments state on the label that the application of another medicament within a time frame of 1 to 2 weeks is not allowed.
  • the device comprises a means for locating the device at the time of administration of the medicament.
  • the device comprises for example a GPS unit that enables locating the whereabouts of the device at the time of administration.
  • the additional information can be used for example for assessing the spatial use of medicaments throughout a farm. This way, health problems associated with location of animals can be recognised more easily.
  • the provision of the device comprises operatively connecting a cartridge containing the medicament to the device.
  • the device is not suitable for actual administration until a cartridge containing the medicament is actually connected to the device (for example directly clamped/clicked to the device, or remotely but having a liquid connection for guiding the medicament from the cartridge to the device).
  • provision of the device simply denote that the device is primed and made suitable for actual administration, but it may still be in a non-administration mode.
  • the operative connection is brought about automatically after the device has verified the medicament identification information.
  • the device checks if a proper cartridge has been connected to the device and only if yes, the operative connection is brought about. If not, it could for example be that no fluid connection between the content of the cartridge and the device is actually established. This way, it can be ensured that a proper medicament is actually used for administration to the animal, for example being suitable for use in the health program, being not passed the expiry date, having the right concentration of active ingredient etc.
  • the cartridge comprises a programmable chip having programmed thereon the medicament identification information
  • the information about the number of doses taken out of the cartridge is programmed on the chip. This way it can be ensured that the proper number of doses is taken out of the cartridge and that a cartridge is replaced timely to prevent any faults when administering medicament to a huge series of animals.
  • the chip is programmed such that after a predetermined amount of doses is taken out of the cartridge, no additional doses can be taken out of the cartridge without reprogramming the chip.
  • the operative connection between the device and the cartridge is broken up as soon as the predetermined amount of doses is taken out of the cartridges. This way, it is made sure that the cartridge with its content can only be used in line with the label to meet the regulatory demands, and thus food safety. Re-filling of the cartridge at the farmer's, for example with an alternative medicament, is also effectively prevented since only with proper reprogramming of the chip, the cartridge can be re-used.
  • Present day technology allows the use of unwanted re-programming by non-authorised third parties, using commonly available soft- and/or hardware tools.
  • information about the administration of the medicament to the animal is linked with data concerning management of the animal, the data being preferably chosen from group comprising food the animal has been offered, the location the animal has on a farm, the local climate at the location, the age of the animal.
  • animal management can be improved by linking the medicament administration data with other animal management data. If for example after assessment of the linked data it appears that a certain quality of food, inherently is followed by a necessary administration of antibiotics three weeks afterwards, there may be a causative connection between the food and the infection that needs to be cured.
  • FIG 1 an exemplary embodiment of the current system is depicted in an exemplary environment.
  • the system features elements and logistics by which a farmer 3 can operate out of a farm office 40 in a particular remote injection site where the animal 1, in this case a pig, is located to administer the required medicament and automatically storing information about the administration of the medicament in the data storage unit present in the ear tag 2.
  • the farmer begins taking a device 10 (which in this case is a needle-less device), corresponding to the medicament to be delivered, out of cupboard 15 that holds multiple devices 10, 11 and 12.
  • This device has a non-administration mode as a default mode, which means that an administration trigger provided by an operator (for example by pulling an actual trigger of the device) will not lead to any medicament being expelled from the device.
  • a cartridge 200 holding multiple doses of the medicament is operatively connected to provide the device for administering the medicament.
  • the farmer 3 enters identification information (operator ID) into the device 10.
  • identification information may be required by the farmer before he is authorized for actually using the device.
  • Determination as to authorization may be made by comparison of information maintained in a central database, such as memory 32.
  • a central database such as memory 32.
  • the device is able to establish a wire-less connection 21, via receiver/transmitter 30, to central processing unit 31, which may access memory 32 for verification purposes.
  • the information is present in laptop computer 33.
  • the required authorization information may originate from any of a variety of sources, such as a system administrator (which may be the farmer himself), a pharmaceutical company (via computer 42), a veterinary's (via computer 43), or the like.
  • the device checks whether the cartridge holding the medicament can de identified.
  • the cartridge (further illustrated in Figure 3 ) comprises a chip having programmed thereon medicament identification information such as the type of medicament, the manufacturer, the manufacturing date, the expiry date, lot number etc. Only after the device has verified the medicament identification information, the contents of the cartridge are made accessible for the delivering features of the device (pump, guides, nozzle etc.), thereby bringing about the operative connection between the cartridge and the device. Then an animal 1 is approached for administration of the medicament.
  • the device 1 constantly searches the presence of a digital storage unit (DSU) being part of ear tag 2.
  • DSU digital storage unit
  • the device typically after the farmer has applied an administration trigger, transmits via antenna 102 (see figure 2 ) a stimulus signal 20 that excites the DSU when being sufficiently near to be able and actually administer the medicament (for example when being pushed against the back of the neck of the animal 1).
  • the excited DSU on its turn then generates a responsive signal where-after the device is switched to an administration mode.
  • the medicament is then administered to the animal by automatic actuation of the required internal operating units (not shown) of the device.
  • information about this administration is send to the DSU and automatically stored therein.
  • the same information in combination with identification information of the animal 1, is send by the device, via receiver/transmitter 30 to the CPU 31 to be stored in memory 32 as well.
  • This memory may be connected to various parties outside the farm office such as a slaughterhouse, via computer 41, the pharmaceutical company and the vet's.
  • Devices 11 and 12 are for example for administering another type of medicament and have corresponding types of injection features, different from device 10.
  • the devices are fully interchangeable and can be used for example simultaneously by multiple operators when administering a medicament to numerous animals in a large herd.
  • the other devices have wire-less connections 22 and 23 with CPU 31 as well (which connection can be continuously or interrupted, for example by shutting the device off, depending on the specifications of the system). This way, each device may at the time of administration of a certain medicament check via CPU 31 whether the administration of the medicament complies with previous administrations given to the same animal. This data may be present in a database in memory 32.
  • the device comprises a GPS unit such that the location of the device can be established at the time of administering a medicament. For this, contact is made to satellite 50 via connection 51.
  • the GPS data can for example be stored in the DSU, but preferably centrally at the farm office.
  • the device is connected to a remote cartridge via a conduit.
  • a conduit may for example be a flexible, tubular member securely interconnected between the cartridge and the device.
  • the farmer may also carry a personal data device, such as an i-Phone TM , Blackberry TM , any other smartphone or handheld device such as a Palm Pilot TM type device on his person in lieu of, or in addition to a data storage unit in the device itself.
  • the robustness of the information ultimately derived from the system relies in a significant part on the reliable linkage between the DSU of a particular animal and the medicament identification information programmed in the chip provided on the cartridge.
  • the current device is the intermediate for actually establishing this reliable linkage.
  • the information gathered in the administration device or, when applicable, the personal data device is gathered via CPU 31 and stored in memory 32.
  • the farmer can use these data for example by introducing them into an animal management system, typically to explore any dependency between medicament use, food that the animal received, the location where the animal is located, the age of the animal or any other data.
  • FIG. 2 schematically shows an administration device according to the invention.
  • This device 10 comprises a hand-held frame 100 (in this case shaped like a gun), that is provided with a sensor 101 for sensing the presence of an animal's body part at the required distance of the device.
  • the device further comprises antenna 102, for transmitting and receiving signals from outside, such as for establishing digital contact with the DSU in ear tag 2.
  • the device comprises restraining elements 103 and 104 to snuggly enclose a cartridge 200 for mechanical connection to the device.
  • the cartridge is provided with a chip 201. Adjacent the chip, the device comprises a chip reader 121 which is able to read and program the chip.
  • the cartridge has a connection element 202, which is pierced by conduit 110.
  • This conduit is in fluid connection with a pressurizing unit 111 that is able to force the medicament through conduit 112 out of nozzle 115 with a pressure larger enough to penetrate the dermis of the animal.
  • the device is also foreseen with a trigger 122, for actually applying a trigger signal to have the device administer the required volume of the medicament, and to initiate sending of the information about the administration of the medicament to the DSU in ear tag 2.
  • This is all coordinated by local processing unit 120, that is connected to the cartridge reader 121, pressurizing unit 111, antenna 102, sensor 101 and trigger 122. This way, the local processing unit 120 in effect controls the switching between an administration mode and a non-administration mode of the device. Switching can be accomplished for example by instructing the pressurizing unit 111 accordingly.
  • the local processing unit takes care of the sending of data about the administration of the medicament to the DSU in ear tag 2, by using antenna 102 as a transmitting means.
  • the trigger for sending the data may be initiated by pushing button/trigger 122 and providing the proper processing in the processing unit.
  • the local processing unit 120 is also the means that establishes, using the proper computer program code, whether or not the device has approached the animal sufficiently, i.e. whether or not the device is within working distance of the animal to administer the medicament.
  • the processing as described with respect to local processing unit 120 may also take (at least partly) place in central processing unit 31, such that the control of the device takes (at least partly) place in a remote controlling processor.
  • the antenna 102 is used for establishing that the device has approached the animal to administer the medicament. In this embodiment it is deemed that the approach is sufficient when the DSU of the corresponding animal is within reach of the antenna as a receiver/transmitter.
  • the chip is (partly) replaced by a bar code (such as a quick response code), a magnetic strip, or other readable means to verify the contents of the cartridge.
  • a bar code such as a quick response code
  • a magnetic strip or other readable means to verify the contents of the cartridge.
  • FIG 3 schematically shows a cartridge.
  • This cartridge 200 comprises a chip 201 having programmed thereon medicament identification information, including information about the number of doses taken out of the cartridge (which may for example be the number of doses still present in the cartridge).
  • the chip is programmed such that when a predetermined number of doses are taken out of the cartridge, when the cartridge is connected to the device, the cartridge reader 121 of the device (see Figure 2 ) transmits a corresponding signal to PU 120, where-after no more medicament will be taken out of the cartridge anymore. The cartridge thereby is no longer operatively connected to the device.
  • the cartridge further comprises positioning means 203 which fit a corresponding means on the device to make sure the cartridge is properly mechanically connected to the device.
  • connection element 202 in this case a rubber stopper.
  • internal guides and pressurizing means to guide any liquid content of the cartridge towards connection element 202.
  • Such guiding and pressurizing elements may for example be elements as commonly known in the art of ink jet cartridges.
  • Figure 4 shows a flow chart of events in a method detailing exemplary steps in performing the method.
  • the method begins at step 300 and, at step 301 the system is powered on by an operator, typically the farmer 3, or a remote device, or by simply manually switching a "power on” button on the administration device of choice. After being powered on, the system requests input of a user ID in step 302. As previously described, the user ID may be input on the device 10 itself.
  • a comparison is done between the user ID entered at step 302 and a list of authorized users maintained in a database stored in memory 32 (see Figure 1 ). If the user ID does not correspond to a user ID maintained in the database, the method of the present invention ends at step 304.
  • step 305 the device is initiated in step 305.
  • device initiation as that referenced in step 305 may include bringing a chip reader 121 (see Figure 2 ) and local processing unit 120 in an operative state.
  • device initiation also includes setting the value for "last DSU found" to "1 minute ago", which is needed in the embodied method. If in decision block 306 no cartridge is identified by a combined operation of the chip reader and the local processing unit, the method ends in step 307.
  • a decision block 308 follows in which it is verified whether or not the cartridge should be regarded as empty (i.e., when as predetermined number of doses have already been taken out of the cartridge). If so, a message to replace the cartridge is displayed (for example as a text message on the device, or an indication light on the device, or a sound from the device or any other device nearby etc.) in step 309. After a predetermined waiting time, typically 60 seconds, the method re-enters decision block 306. If on the other hand in block 308 it is established that the cartridge is not empty, the device, in step 310, starts searching for a nearby DSU as previously described.
  • step 321 it is established when the last DSU was found. If this value is at less than 10 minutes, the method carries on with step 310 to try and find a DSU. If this value is more than 10 minutes, the method ends at step 322. If in decision block 320 it is established that a DSU is nearby (i.e. within, at or near administration range) the device automatically switches to an administration mode in step 323. If in step 324, the administration trigger is actuated by the operator, it is checked whether the same DSU as found in step 320 is still the DSU within reach of the device. If not, the device automatically switches to a non-administration mode in step 327 and begins searching for a new DSU in step 310.
  • the syringe (which may be without a needle) is actuated automatically and data about the administration of the medicament to the animal is send to the DSU in step 326. Thereafter, the device is switched to a non-administration mode in step 327 and continues as described before. This way, multiple animals can have the medicament administered sequentially while at the same time information about the medicament administered is automatically stored in the corresponding DSU's.
  • the device after step 327 the device cannot be switched to the administration mode by approaching the same animal for a predetermined amount of time, typically between 60 seconds and 2 weeks.
  • a short time can for example be chosen for preventing that an animal is erroneously given two shots of the same medicament at virtually the same time.
  • the long time can for example be chosen if the medicament applied has a label stating that "no other medicaments should be applied within 2 weeks after the administration".
  • steps 308 and 310 there is another decision block (not shown) in which it is checked whether the trigger for actually applying the medicament is actuated by the operator of the device, for example by pushing trigger 122 of the device (see Figure 2 ). If so, the DSU is searched in step 310 and if found in step 320, the process continues with step 323, directly followed by steps 326 and 327 (skipping steps 324 and 325).

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  • Veterinary Medicine (AREA)
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  • Wood Science & Technology (AREA)
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  • Animal Behavior & Ethology (AREA)
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Description

    TECHNICAL FIELD
  • The present invention pertains to a device and system for tracing medicaments administered to an animal. In particular the invention pertains to a device and system that may provide high integrity information with regard to the medicaments that an animal has received throughout its lifespan.
  • BACKGROUND INFORMATION
  • Regular and accurate administration of medicaments such as vaccines and antibiotics to animals, in particular live-stock animals such as swine and ruminants, is critical to the physical health of the animals, the resulting safety and quality of the food products derived from these animals, and the sense of confidence the consumer has in the wholesomeness of these food products.
  • With regard to live-stock animals a vast number of different often complex medicaments and administration regimes have been developed and implemented in order to generate healthy animals that produce a safe, high quality and high quantity of food products. The pricing of the end product is traditionally based on the quality of the slaughtered meat. The premium for high quality meat is high and thus, the art has been in search fro optimum treatment regimes for many decades. However, the last few years food safety is becoming an increasing quality factor of slaughtered meat. The consumer is willing to pay a premium for meat that can be traced for the medicaments administered. High integrity information with regard to the medicaments that an animal has received throughout its lifespan has thus become increasingly important fro the livestock industry.
  • A common problem however is the fact that current methods and systems for tracing medicaments administered to an animal still fail to provide the kind of high integrity information that takes away the concerns by consumers over the correctness of the tracing, and, in relation to this, the residual effects of the medicaments on the physiology of the consumer itself. There are several reasons why current methods and system fail in this respect. Firstly, even in the relatively short live of a live-stock animal (typically six months for a pig, two years for a head of cattle) the number of medicaments administered to an individual animal may be very high. Additionally, the number of animals a farmer must raise to be profitable are very high and still increasing. Even if a farmer intends to be diligent in keeping records of medicaments administered to each and every animal, the logistics in keeping such records may make the task very difficult, time consuming and prone to mistakes. In particular the cost of labour is becoming an asset that is an increasingly consuming a part of the tight profit margins, and thus, putting extra effort in keeping track of the medicaments administered is hard to accomplish economically. All-in-all, this will not decrease the consumers concerns about food safety, and hence, the theoretical premium for safe food can hardly be collected.
  • Numerous advances have been proposed or even put to practice in the market. In the USA, Global Animal Management (Summit, New Jersey) provides a system called Tri-Merit to enable tracing of individual animals and the medicaments they have received, from birth to slaughterhouse. Verilogik (San Antonia, Texas) markets a system called the VAC-TRAC Verification System (VTVS), which is used to verify source and processing histories in livestock and meat production.
  • JP2005160391 discloses an animal management system which enables traceability of medicinal agents administrated to an animal. The system includes tags to be put on animals, a syringe to administrate the medicinal agents and remote processing means which are able to communicate with the syringe. Upon identification of a specific animal by means of the tag read by the syringe, the right amount of medicinal agents to be delivered is enquired at the remote processing means. After the medicinal agent is administrated, the information is registered into a database.
  • Still, there is a need for a device and system in which high integrity information about medicaments administered to an animal can be obtained, thus providing adequate tracing thereof to meet consumers demands relating to food safety. In particular, there is a need for a device and system in which information relating to the administration of medicaments is automatically generated and recorded in the process of administration of the medicaments while at the same time decreasing the risk of a wrongful administration (e.g. the wrong medicament, too much of the medicament etc.).
  • There is a need for a dedicated administration device to meet the concerns of the consumer, in particular to provide more security about the accurateness of the actual administration of a medicament.
  • SUMMARY OF THE INVENTION
  • In order to meet the objects of the invention, an administration device, as defined in claim 1, has been devised comprising administration means for administering a medicament to an animal, the device having two modes, a default non-administration mode and an administration mode, the latter allowing administration of the medicament to the animal, a switching means to switch the device between the said modes, an establishing means to establish that the device is within a working distance of the animal to administer the medicament, the switching means and establishing means being operatively connected such that the switching means switches the device from the default mode to the administration mode after the establishing means has established that the device is within a working distance of the animal to administer the medicament, processing means that upon administration of the medicament automatically provide a data sending means to send information about the administration of the medicament to a data storage unit being connected to an animal, and the switching means to switch the device to the default non-administration mode. A preferred embodiment is defined in the dependent claim.
  • This device makes use of existing technology of connecting data storage units to animals, for example as described in French patent application FR 2 898 011, published 7th of September 2007 ), the units (for example an EID/RFID present in an ear tag to provide a tamper-resistant electronic identification as well as a data storage possibility) storing data about actual administration of medicaments to the animal. However, the storage of the data in the storage unit depends on an operator sending the data to the storage unit and thus is prone to the same disadvantages as known from other prior art techniques. It was applicant's recognition that the existing technology can be markedly improved when automatically storing information about the administration of the medicament in the data storage unit right after the actual administration. In order to accomplish this accurately, the actual administration with the device triggers the storing of the information. For this, the device may communicate directly with the storage unit at the moment of administration. In order to contribute significantly to the reliability of the present invention, applicant further recognised that in the disclosed method, not forming part of the invention, it is advantageous to use an administration device that has a default non-administration mode (i.e. a mode wherein a medicament cannot be applied by using the normal administration tools of the device, typically a trigger or button). This does not only increase safety when handling the device (auto-injection for example by an operator can virtually be excluded) but it gives the opportunity to allow administration only when having reached an actual administration site of an animal and at the same time being near the storage unit: in the present method, only when the device has approached the animal to administer the medicament, the device is switched to an administration mode, allowing the administration of the medicament to the animal with the device, which on its turn triggers the automatic storing of information about the administration of the medicament in the data storage unit and at the same time triggers the automatic switching of the device to the default non-administration mode. The latter thus preventing double administration to the same animal. With this method, it can be virtually excluded that medicaments can be wrongfully applied and also, it is ensured that for each and every administration, information about it is directly and immediately stored in the unit that is in actual connection with the animal. This way, whatever happens with the animal, if the present method is used for the administration of medicaments, the animal itself harbours the data storage unit that has all the information about each and every medicament applied to the animal, while at the same time virtually securing that the data is correct since erroneous administration of medicaments and administration without corresponding data being stored are prevented.
  • The present invention is also embodied in a system for applying the above method wherein the system comprises a data storage unit connected to an animal, a device for administering a medicament to the animal, the device having two modes, a default non-administration mode and an administration mode, the latter allowing administration of the medicament to the animal, a switching means to switch the device between the said modes, an establishing means to establish that the device is within a working distance of the animal to administer the medicament, the switching means and establishing means being operatively connected such that the switching means switches the device from the default mode to the administration mode after the establishing means has established that the device is within a working distance of the animal to administer the medicament, and processing means that upon administration of the medicament automatically provide a data sending means to send information about the administration of the medicament to the animal to the data storage unit, and the switching means to switch the device to the default non-administration mode.
  • The invention thus pertains to an administration device for use in the method and system as described here-above, the device comprising administration means for administering a medicament to an animal, the device having two modes, a default non-administration mode and an administration mode, the latter allowing administration of the medicament to the animal, a switching means to switch the device between the said modes, an establishing means to establish that the device is within a working distance of the animal to administer the medicament, the switching means and establishing means being operatively connected such that the switching means switches the device from the default mode to the administration mode after the establishing means has established that the device is within a working distance of the animal to administer the medicament, and processing means that upon administration of the medicament automatically provide a data sending means to send information about the administration of the medicament to a data storage unit being connected to an animal, and the switching means to switch the device to the default non-administration mode.
  • DEFINITIONS
  • Medicament: any substance or composition of matter able to prevent, treat, ameliorate or cure a disease or disorder. Typical medicaments used for live-stock are antibiotics, vaccines, anti-inflammatory agents, muscle-relaxants and other small molecule pharmaceuticals.
  • To connect operatively: to establish a working relationship between two parts.
  • Data storage unit: any unit that comprises means for storing data, such as an RFID chip, a magnetic chip or any other electronic memory, in particular for example an EEPROM, RAM, NVM or FLASH memory. The unit may be comprises in an identification means typically used for identification of an animal such as an ear tag, implant, or bolus, or a combination of any of these.
  • Automatically: without operator intervention. An automatic action may however be operator initiated or ended.
  • To verify: to read and check for origin and/or correctness.
  • Medicament identification information: information enabling to assess the identity of the medicament including e.g. origin, content, date of manufacture, expiry date, volume to be administered.
  • A cartridge: an, often disposable, container which holds a active ingredient to be applied by a device to which the cartridge can be operatively connected.
  • DISCLOSURES OF THE INVENTION
  • In a method, not forming part of the invention, described by the present disclosure the device is brought in a position to administer the medicament, where-after an administration trigger is given by an operator of the device, the trigger automatically resulting in establishing whether the device has approached the animal sufficiently, and if so, in an automatic administration of the medicament. In this embodiment the device is operated in a fashion that is common for any (semi-)automatic administration device such as for example the device as known from US 7,601,137 . The device is simply brought in an administration position and then the trigger is pulled to actually accomplish administration of the medicament. Using the present invention however, upon pulling the trigger, it is established immediately whether the device has approached the animal sufficiently, for example by using an optical or contact sensor on the device. If so, the devices than switches to the administration mode and administration of the medicament is automatically performed. The time that lapses between the pulling of the trigger and the actual administration need not be more than a few milliseconds. This way, the operator does not experience any delay in the actual administration. If it is established upon pulling the trigger that the device has not approached the animal sufficiently, the device will not switch to an administration mode and the pulling of the trigger will not lead to an actual administration. This way, it can be prevented that a medicament leaves the administration device without being actually administered to an animal.
  • In another example of the method, not forming part of the invention, described by the present disclosure, establishing that the device has approached the animal is performed by checking whether the device is within predetermined distance from the data storage unit. In this embodiment, use can be made of the fact that present day technology has advanced such that a typical data storage unit can be easily sensed wireless. In this embodiment, the actual administration can only take place when the data storage unit is within a predetermined distance of the device. This distance can be chosen such that the device is able to send data reliably to the data storage unit at the moment of (or right after) administration. This way, it can be virtually ensured, not only that actual administration can take place at the moment an operator triggers administration, but also, that data concerning this administration can be automatically stored in the data storage unit by sending these data from the device to the unit.
  • In a further example, the device is provided with a means to establish a digital contact with the data storage unit when the device is within the predetermined distance, the contact allowing data to be exchanged between the storage unit and the device. In this embodiment, data cannot only be send from the device to the unit, but data can actually be exchanged by the device and the unit. Typically, the device checks at the moment an operator triggers an administration operation with the device, what animal is bound to receive the medicament. This check can for example be used as an extra measure to assess whether the intended administration complies with the administration scheme for the animal. If not, this could lead to a block for the switch to the administration mode, even if the device has approached the animal sufficiently for enabling an actual administration operation.
  • In yet a further example, wherein the administering of the medicament automatically leads to the device receiving animal identification information stored in the data storage unit, the device stores this animal identification information together with the information about the administration of the medicament in a memory, the memory being present in the device or remote from the device. In this embodiment the information package that is relevant for assessing i.a. food safety is not only stored in the data storage unit connected to the animal, but additionally in a memory non connected to the animal, either in the device itself or a remote memory such as a memory of a central server at the farmer's. This advantageously enables the use of this data for additional purposes that may even further address the concerns of the consumer about food safety, animal wellness and proper medicament use. With regard to the latter, in still a further embodiment the data stored in the memory being present in the device or remote from the device is accessible by a second administration device with the purpose of checking compliance of a medicament administered by the first device to the animal, with a second medicament to be applied with the second device to the same animal.
  • In another example, after administration of the medicament to the animal, the device cannot be switched to the administration mode by approaching the same animal for a predetermined amount of time. This way it can be prevented for example that the same animal receives an unwanted second dose of the medicament or that it receives a dose of another medicament whereas this is not allowed after administration of the first medicament. With regard to the latter, many labels of medicaments state on the label that the application of another medicament within a time frame of 1 to 2 weeks is not allowed.
  • In yet another example the device comprises a means for locating the device at the time of administration of the medicament. In this embodiment, the device comprises for example a GPS unit that enables locating the whereabouts of the device at the time of administration. The additional information can be used for example for assessing the spatial use of medicaments throughout a farm. This way, health problems associated with location of animals can be recognised more easily.
  • In another example the provision of the device comprises operatively connecting a cartridge containing the medicament to the device. In this embodiment, the device is not suitable for actual administration until a cartridge containing the medicament is actually connected to the device (for example directly clamped/clicked to the device, or remotely but having a liquid connection for guiding the medicament from the cartridge to the device). Hence, the terms "provision of the device" simply denote that the device is primed and made suitable for actual administration, but it may still be in a non-administration mode.
  • In a further example wherein the cartridge carries medicament identification information, the operative connection is brought about automatically after the device has verified the medicament identification information. In this embodiment the device checks if a proper cartridge has been connected to the device and only if yes, the operative connection is brought about. If not, it could for example be that no fluid connection between the content of the cartridge and the device is actually established. This way, it can be ensured that a proper medicament is actually used for administration to the animal, for example being suitable for use in the health program, being not passed the expiry date, having the right concentration of active ingredient etc.
  • In yet a further example, wherein the cartridge comprises a programmable chip having programmed thereon the medicament identification information, the information about the number of doses taken out of the cartridge, is programmed on the chip. This way it can be ensured that the proper number of doses is taken out of the cartridge and that a cartridge is replaced timely to prevent any faults when administering medicament to a huge series of animals.
  • In still a further example, the chip is programmed such that after a predetermined amount of doses is taken out of the cartridge, no additional doses can be taken out of the cartridge without reprogramming the chip. In this embodiment, the operative connection between the device and the cartridge is broken up as soon as the predetermined amount of doses is taken out of the cartridges. This way, it is made sure that the cartridge with its content can only be used in line with the label to meet the regulatory demands, and thus food safety. Re-filling of the cartridge at the farmer's, for example with an alternative medicament, is also effectively prevented since only with proper reprogramming of the chip, the cartridge can be re-used. Present day technology allows the use of unwanted re-programming by non-authorised third parties, using commonly available soft- and/or hardware tools.
  • In an example of the method, not forming part of the invention, described by the present disclosure, information about the administration of the medicament to the animal is linked with data concerning management of the animal, the data being preferably chosen from group comprising food the animal has been offered, the location the animal has on a farm, the local climate at the location, the age of the animal. In this embodiment, animal management can be improved by linking the medicament administration data with other animal management data. If for example after assessment of the linked data it appears that a certain quality of food, inherently is followed by a necessary administration of antibiotics three weeks afterwards, there may be a causative connection between the food and the infection that needs to be cured.
  • BRIEF DESCRIPTION OF THE DRAWINGS
    • Figure 1 schematically shows a system according to the invention.
    • Figure 2 schematically shows an administration device according to the invention.
    • Figure 3 schematically shows a cartridge described in the present disclosure.
    • Figure 4 shows a flow chart of events in a method described in the present disclosure.
    DETAILED DESCRIPTION
  • In figure 1 an exemplary embodiment of the current system is depicted in an exemplary environment. The system features elements and logistics by which a farmer 3 can operate out of a farm office 40 in a particular remote injection site where the animal 1, in this case a pig, is located to administer the required medicament and automatically storing information about the administration of the medicament in the data storage unit present in the ear tag 2.
  • In operation, the farmer begins taking a device 10 (which in this case is a needle-less device), corresponding to the medicament to be delivered, out of cupboard 15 that holds multiple devices 10, 11 and 12. This device has a non-administration mode as a default mode, which means that an administration trigger provided by an operator (for example by pulling an actual trigger of the device) will not lead to any medicament being expelled from the device. To this device a cartridge 200 holding multiple doses of the medicament is operatively connected to provide the device for administering the medicament. Then, the farmer 3 enters identification information (operator ID) into the device 10. Depending on the desires of the system administrators, different levels and types of information may be required by the farmer before he is authorized for actually using the device. Determination as to authorization may be made by comparison of information maintained in a central database, such as memory 32. For this, the device is able to establish a wire-less connection 21, via receiver/transmitter 30, to central processing unit 31, which may access memory 32 for verification purposes. Alternatively, the information is present in laptop computer 33. The required authorization information may originate from any of a variety of sources, such as a system administrator (which may be the farmer himself), a pharmaceutical company (via computer 42), a veterinary's (via computer 43), or the like.
  • As far as the specifics of authorization are concerned, it may be sufficient for the farmer 3 to simply enter a PIN number or the like. It is understood that a substantial aspect of the value of information in the system is the guarantee that the information is devoid of errors which may originate from non-authorized, untrained or other faulty use.
  • In preparation for an administration session, the device checks whether the cartridge holding the medicament can de identified. For this, the cartridge (further illustrated in Figure 3) comprises a chip having programmed thereon medicament identification information such as the type of medicament, the manufacturer, the manufacturing date, the expiry date, lot number etc. Only after the device has verified the medicament identification information, the contents of the cartridge are made accessible for the delivering features of the device (pump, guides, nozzle etc.), thereby bringing about the operative connection between the cartridge and the device. Then an animal 1 is approached for administration of the medicament. The device 1 constantly searches the presence of a digital storage unit (DSU) being part of ear tag 2. For this, the device, typically after the farmer has applied an administration trigger, transmits via antenna 102 (see figure 2) a stimulus signal 20 that excites the DSU when being sufficiently near to be able and actually administer the medicament (for example when being pushed against the back of the neck of the animal 1). The excited DSU on its turn then generates a responsive signal where-after the device is switched to an administration mode. The medicament is then administered to the animal by automatic actuation of the required internal operating units (not shown) of the device. At the same time, information about this administration is send to the DSU and automatically stored therein. In this embodiment, the same information, in combination with identification information of the animal 1, is send by the device, via receiver/transmitter 30 to the CPU 31 to be stored in memory 32 as well. This memory may be connected to various parties outside the farm office such as a slaughterhouse, via computer 41, the pharmaceutical company and the vet's.
  • Devices 11 and 12 are for example for administering another type of medicament and have corresponding types of injection features, different from device 10. In another embodiment, the devices are fully interchangeable and can be used for example simultaneously by multiple operators when administering a medicament to numerous animals in a large herd. The other devices have wire-less connections 22 and 23 with CPU 31 as well (which connection can be continuously or interrupted, for example by shutting the device off, depending on the specifications of the system). This way, each device may at the time of administration of a certain medicament check via CPU 31 whether the administration of the medicament complies with previous administrations given to the same animal. This data may be present in a database in memory 32.
  • In a preferred embodiment, the device comprises a GPS unit such that the location of the device can be established at the time of administering a medicament. For this, contact is made to satellite 50 via connection 51. The GPS data can for example be stored in the DSU, but preferably centrally at the farm office.
  • In an alternative embodiment, the device is connected to a remote cartridge via a conduit. It is foreseen that it some case, in particular when the cartridge holds large amounts of medicament (for example a few hundred to thousand doses), that the farmer retains the cartridge on an arm, a leg, his jacket etc. for ease of handling the administration device. The medicament conduit may for example be a flexible, tubular member securely interconnected between the cartridge and the device. The farmer may also carry a personal data device, such as an i-Phone, Blackberry, any other smartphone or handheld device such as a Palm Pilot type device on his person in lieu of, or in addition to a data storage unit in the device itself.
  • The robustness of the information ultimately derived from the system relies in a significant part on the reliable linkage between the DSU of a particular animal and the medicament identification information programmed in the chip provided on the cartridge. The current device is the intermediate for actually establishing this reliable linkage. Periodically, or after each administration, the information gathered in the administration device or, when applicable, the personal data device is gathered via CPU 31 and stored in memory 32. At the farm office, the farmer can use these data for example by introducing them into an animal management system, typically to explore any dependency between medicament use, food that the animal received, the location where the animal is located, the age of the animal or any other data.
  • Figure 2 schematically shows an administration device according to the invention. This device 10 comprises a hand-held frame 100 (in this case shaped like a gun), that is provided with a sensor 101 for sensing the presence of an animal's body part at the required distance of the device. The device further comprises antenna 102, for transmitting and receiving signals from outside, such as for establishing digital contact with the DSU in ear tag 2. The device comprises restraining elements 103 and 104 to snuggly enclose a cartridge 200 for mechanical connection to the device. The cartridge is provided with a chip 201. Adjacent the chip, the device comprises a chip reader 121 which is able to read and program the chip. The cartridge has a connection element 202, which is pierced by conduit 110. This conduit is in fluid connection with a pressurizing unit 111 that is able to force the medicament through conduit 112 out of nozzle 115 with a pressure larger enough to penetrate the dermis of the animal. The device is also foreseen with a trigger 122, for actually applying a trigger signal to have the device administer the required volume of the medicament, and to initiate sending of the information about the administration of the medicament to the DSU in ear tag 2. This is all coordinated by local processing unit 120, that is connected to the cartridge reader 121, pressurizing unit 111, antenna 102, sensor 101 and trigger 122. This way, the local processing unit 120 in effect controls the switching between an administration mode and a non-administration mode of the device. Switching can be accomplished for example by instructing the pressurizing unit 111 accordingly. Also, the local processing unit takes care of the sending of data about the administration of the medicament to the DSU in ear tag 2, by using antenna 102 as a transmitting means. The trigger for sending the data may be initiated by pushing button/trigger 122 and providing the proper processing in the processing unit. The local processing unit 120 is also the means that establishes, using the proper computer program code, whether or not the device has approached the animal sufficiently, i.e. whether or not the device is within working distance of the animal to administer the medicament. The processing as described with respect to local processing unit 120, may also take (at least partly) place in central processing unit 31, such that the control of the device takes (at least partly) place in a remote controlling processor.
  • In an alternate embodiment, instead of sensor 101, the antenna 102 is used for establishing that the device has approached the animal to administer the medicament. In this embodiment it is deemed that the approach is sufficient when the DSU of the corresponding animal is within reach of the antenna as a receiver/transmitter.
  • In alternate embodiments, the chip is (partly) replaced by a bar code (such as a quick response code), a magnetic strip, or other readable means to verify the contents of the cartridge.
  • Figure 3 schematically shows a cartridge. This cartridge 200 comprises a chip 201 having programmed thereon medicament identification information, including information about the number of doses taken out of the cartridge (which may for example be the number of doses still present in the cartridge). The chip is programmed such that when a predetermined number of doses are taken out of the cartridge, when the cartridge is connected to the device, the cartridge reader 121 of the device (see Figure 2) transmits a corresponding signal to PU 120, where-after no more medicament will be taken out of the cartridge anymore. The cartridge thereby is no longer operatively connected to the device.
  • The cartridge further comprises positioning means 203 which fit a corresponding means on the device to make sure the cartridge is properly mechanically connected to the device. Also depicted in Figure 3 is the connection element 202, in this case a rubber stopper. Not depicted in Figure 3 are internal guides and pressurizing means to guide any liquid content of the cartridge towards connection element 202. Such guiding and pressurizing elements may for example be elements as commonly known in the art of ink jet cartridges.
  • Figure 4 shows a flow chart of events in a method detailing exemplary steps in performing the method. The method begins at step 300 and, at step 301 the system is powered on by an operator, typically the farmer 3, or a remote device, or by simply manually switching a "power on" button on the administration device of choice. After being powered on, the system requests input of a user ID in step 302. As previously described, the user ID may be input on the device 10 itself. At decision block 303, a comparison is done between the user ID entered at step 302 and a list of authorized users maintained in a database stored in memory 32 (see Figure 1). If the user ID does not correspond to a user ID maintained in the database, the method of the present invention ends at step 304. If on the other hand, the user is deemed to be an authorized user, the device is initiated in step 305. Depending on the specific system configuration and requirements, device initiation as that referenced in step 305 may include bringing a chip reader 121 (see Figure 2) and local processing unit 120 in an operative state. In this embodiment, device initiation also includes setting the value for "last DSU found" to "1 minute ago", which is needed in the embodied method. If in decision block 306 no cartridge is identified by a combined operation of the chip reader and the local processing unit, the method ends in step 307. If a cartridge is identified, an operative connection between the cartridge and the device is brought about and a decision block 308 follows in which it is verified whether or not the cartridge should be regarded as empty (i.e., when as predetermined number of doses have already been taken out of the cartridge). If so, a message to replace the cartridge is displayed (for example as a text message on the device, or an indication light on the device, or a sound from the device or any other device nearby etc.) in step 309. After a predetermined waiting time, typically 60 seconds, the method re-enters decision block 306. If on the other hand in block 308 it is established that the cartridge is not empty, the device, in step 310, starts searching for a nearby DSU as previously described. If in decision block 320 it is established that no DSU is nearby, in block 321 it is established when the last DSU was found. If this value is at less than 10 minutes, the method carries on with step 310 to try and find a DSU. If this value is more than 10 minutes, the method ends at step 322. If in decision block 320 it is established that a DSU is nearby (i.e. within, at or near administration range) the device automatically switches to an administration mode in step 323. If in step 324, the administration trigger is actuated by the operator, it is checked whether the same DSU as found in step 320 is still the DSU within reach of the device. If not, the device automatically switches to a non-administration mode in step 327 and begins searching for a new DSU in step 310. If on the other hand it is established that the same DSU is still near the device, the syringe (which may be without a needle) is actuated automatically and data about the administration of the medicament to the animal is send to the DSU in step 326. Thereafter, the device is switched to a non-administration mode in step 327 and continues as described before. This way, multiple animals can have the medicament administered sequentially while at the same time information about the medicament administered is automatically stored in the corresponding DSU's.
  • In an embodiment, after step 327 the device cannot be switched to the administration mode by approaching the same animal for a predetermined amount of time, typically between 60 seconds and 2 weeks. A short time can for example be chosen for preventing that an animal is erroneously given two shots of the same medicament at virtually the same time. The long time can for example be chosen if the medicament applied has a label stating that "no other medicaments should be applied within 2 weeks after the administration".
  • In an alternate embodiment, between steps 308 and 310 there is another decision block (not shown) in which it is checked whether the trigger for actually applying the medicament is actuated by the operator of the device, for example by pushing trigger 122 of the device (see Figure 2). If so, the DSU is searched in step 310 and if found in step 320, the process continues with step 323, directly followed by steps 326 and 327 (skipping steps 324 and 325).

Claims (2)

  1. An administration device comprising:
    - administration means for administering a medicament to an animal, the device having two modes, a default non-administration mode and an administration mode, the latter allowing administration of the medicament to the animal,
    - a switching means to switch the device between the said modes,
    - an establishing means to establish that the device is within a working distance of the animal to administer the medicament,
    - the switching means and establishing means being operatively connected such that the switching means switches the device from the default mode to the administration mode after the establishing means has established that the device is within a working distance of the animal to administer the medicament,
    - processing means configured such that upon administration of the medicament automatically they provide a data sending means to send information about the administration of the medicament to a data storage unit being connected to an animal, and they provide the switching means to switch the device to the default non-administration mode.
  2. A system comprising:
    - a device according to claim 1 and
    - a data storage unit connectable to an animal for sending said information about the administration of the medicament.
EP13703340.3A 2012-01-25 2013-01-23 Device and system for tracing medicaments administered to an animal Active EP2806821B1 (en)

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US6558352B1 (en) * 2000-05-30 2003-05-06 Verilogik, Inc. System and method for variable dosage medicine delivery
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JP4512761B2 (en) * 2003-12-03 2010-07-28 雪生 ▲高▼橋 Animal management system
US20070074722A1 (en) * 2005-09-21 2007-04-05 Kurve Technology, Inc. Medicament delivery control, monitoring, and reporting system and method
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FR2898011A1 (en) 2006-03-02 2007-09-07 Jacques Gascuel Wild, farm or domestic animal e.g. bovine, tracing/managing device for use during e.g. calving, has chip containing transponder with RAM or electrically EPROM to store information e.g. list of diseases undergone by animal, and treatments

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