Platforms and systems for therapeutic procedures

Abstract

A portable therapeutic platform (10) for use in a therapeutic procedure comprises: (a) at least one compartment (14) for containing at least one therapeutically effective item required to perform the therapeutic procedure; and (b) at least one electronic communication device (17, 47, 47A) for receiving and transmitting information about the environment surrounding the platform (10) and including the platform (10) itself. Use of the platform (10) is conveniently managed by a system (100) that transmits information about the environment surrounding the platform (10) and including the platform (10) itself between the electronic communication device (17, 47, 47A) and a computer system (200) including a processor (210) for processing the information; and initiates a control response to the processed information. The platform (10) and system (100) are suitable for use in addressing a range of public health issues and as a countermeasure to biosecurity threats.

Description

Technical Field

[0001] The present invention relates to a platform and system for a treatment process, such as for administering at least one injection by injection. In other applications, such a platform and system are suitable for use by 1) patients who need intravenous, intramuscular or other forms of drug or vaccine administration (including injection by bifurcated needle), such as for the treatment of single or multiple episodes of chronic diseases (such as insulin-dependent diabetes) or vaccinations (such as cholera or smallpox vaccines); and / or 2) patients who need vaccination for diseases, especially patients in outpatient settings; and / or 3) entities that typically control patient treatment in outpatient settings, which can collect and process data collected from platforms and systems to optimize the health status of patients, including in public health crises or emergencies, where emergency management measures are required, such as providing vaccines and / or reagents to patients. In this regard, the treatment platform and system can also be used in a biosafety countermeasure setting to be applied to protect the population from harmful organisms or biochemical threats involving viruses or other biological attack methods. Background Art

[0002] It is well known that certain infectious and chronic diseases require the anticipatory, timely, targeted, and / or scheduled administration of vaccines and medications. Examples of therapeutic procedures range from the treatment of insulin-dependent diabetes to the inoculation of infectious diseases, typically through vaccination, to procedures designed to address public health crises or emergencies. In reality, such procedural administration methods of medications or vaccines, while effective in achieving therapeutic procedures, do not usually always occur in a therapeutic setting and, given this limitation, should still occur in a manner that maximizes therapeutic benefit and safety for patients, health care workers, and the community. Issues of particular concern here are typically dispensing errors (which become even more problematic in biosecurity threats or public health emergencies because of the control of the correct identification of the correct medication or vaccine and its dosage in an environment that may require the involvement of non-medically trained personnel), and more specifically include the authenticity of the medication or vaccine, the dosage of the medication or vaccine; the quantity and nature of any reagents and / or diluents required for the medication and the appropriate delivery components; and the handling of needles and sharp objects.

[0003] The first major category of problems arises from a lack of control over therapeutic procedures performed in a non-therapeutic setting. There are multiple inherent risks associated with the provision of incorrect and / or incomplete prescribed items for the performance of a therapeutic procedure and the associated costs to the patient and the community. This is particularly true in the case of any procedure involving intravenous administration. In this setting, the equipment used to deliver the injection / diluent and needles and syringes and / or cannulas are typically separated from the shipping, often separate, loose items used to perform multiple aspects of the intended procedure, as well as disposal containers for sharps. Thus, the injection, needles, syringes, and cannulas may be packaged for individual use, but lack control and information on variables such as the nature of the injection, the dose of the injection to be administered, the amount of diluent used, and the use of other items required for the procedure.

[0004] Another class of issues can arise from the way items used in therapeutic procedures are packaged. Safety and efficacy depend on packaging containing the correct items for the procedure. However, errors can occur and the wrong items, whether physical or pharmaceutical, can be packaged together. While more likely to be a problem in informal settings where packaging is done without adequate quality assurance, such errors can also occur in more complex therapeutic packaging environments and are particularly a problem for secondary packaging.

[0005] Both of these categories raise safety concerns, but the lack of information about what actually happens when such procedures are performed also means that, although well planned, they are not actually tailored to the patient's needs. Alternatively, the lack of information leads to a failure to compensate the patient for poor surgical performance or to opportunities to make the procedure safer and more effective.

[0006] Such issues become more acute in biosecurity situations, where such packages may need to be produced urgently to protect populations from biochemical or biological threats, particularly unconfirmed threats, which could include viral threats or other biological means of attack. In such cases, therapeutic packages might carry an antidote (perhaps in the form of a vaccine) to immunize a population.

[0007] Drugs for use against biosecurity threats may also be provided, often under the supervision of an entity such as a government agency. Such packages should be coordinated for use, and antidotes should be tailored to threats that may change in real time, such as in the form of mutated viruses. In this case, the package manufacturing center needs to modify the antidote, or more typically receive a modified antidote from another source, in order to deliver it to the threatened population, which presents a significant logistical challenge. However, to the applicant's knowledge, current technology does not make it possible to respond quickly to this problem.

[0008] An object of the present invention is to provide platforms and systems for therapeutic procedures that flexibly address, at least to some extent, information deficits, control, logistics, and packaging issues that may hinder the safe and effective implementation of a range of therapeutic procedures, including in emergency responses to biosecurity threats or other public health crises or emergencies. Summary of the invention

[0009] In view of this purpose, one embodiment of the present invention provides a portable therapeutic platform for a therapeutic procedure, comprising: (a) at least one compartment for containing at least one therapeutically effective item required to perform the therapeutic procedure; and (b) an electronic communication device for receiving and transmitting information about the environment surrounding the platform and including the platform itself. One form of the platform is a package as described below; although these terms are used interchangeably herein, this is not meant to be limiting.

[0010] Another embodiment of the present invention provides a system for managing a portable therapeutic platform for a therapeutic procedure, comprising the following steps: (a) providing at least one platform comprising at least one compartment for containing at least one therapeutically effective item required for conducting the therapeutic procedure and an electronic communication device for receiving and transmitting information about the environment surrounding the platform and the platform itself; (b) transmitting information about the environment surrounding the platform and including at least one platform itself between the electronic communication device and a computer system including a processor for processing the information; and (c) initiating a control response to the processed information.

[0011] "Therapeutically effective" means that an item, such as a drug, diluent, or physical item, such as a syringe or cannula, has an effect on a patient. Desirably, the effect improves or protects the patient's health, but is not limited to these situations. Although collecting information about process packaging usage may help improve the health of the patient or future patients, in this case, the effect may also be harmful.

[0012] Desirably, the electronic communication device communicates with the computer system via a wireless communication network, desirably a secure wireless communication network, so that information and / or instructions (a form of control response to information received from the treatment package) can be communicated between the portable platform or package and the computer system. The computer system will typically form part of the control center of the treatment process, and will also typically be managed by a government agency in the event of a public health crisis or emergency (including a biosafety threat). The information may include, but is not limited to, information about the use of the package, which may include sensors that detect when, how and / or where the items in the package are used, or sensors that indicate that the package should be used. Instructions may include, but are not limited to, opening the package or indicating when it is needed. For example, a treatment package may be issued to protect people from possible biosafety threats. However, the relevant authorities may not yet have evidence that the treatment package must be used for protection. When such evidence is received, instructions may be issued for the population or one or more segments of the population, which are determined by geographic location or processing of usage data, as described below. Preferably, such instructions sent from the computer system to each platform or package via the wireless communication network may include, for example, activating the treatment package by providing access to the package. This makes the treatment response to the threat more precise. These packages may include, or may be used in conjunction with, a messaging system, for example, provided by a mobile phone or smart device having an identifier associated with the package and a unique identification code provided for the electronic communication device contained in the package.

[0013] Where many such therapeutic packages are deployed, perhaps to respond to an epidemic or public health crisis, including responding to a biosafety threat, the computer system can receive multiple information inputs from multiple therapeutic packages, which show how, when and where to use them, i.e., tracking information. The processor can process such information to determine the strategy for using the package in real-time and future scenarios, and determine which one needs to be activated to respond to. Such information will be expected to achieve statistical process control and higher precision for the response to biosafety threats or other public health crises by deploying therapeutic packages as described herein. Statistical process control can be supplemented by using machine learning techniques, by the processing of information by the processor, to improve the efficacy of the deployment of therapeutic packages as described herein, while minimizing the cost of such deployment or actually not deploying, no matter how it is measured. The computer system can also control the logistics mode of deploying the package to the target population, for example, by an autonomous driving vehicle, a robot, an unmanned aerial vehicle or a similar computer-controllable means of transport, which is particularly advantageous in the case where the threat is highly contagious (e.g., a viral infection).

[0014] Various methods of communication are suitable, communication via a wireless network is preferred, if not required. However, provision may be made for downloading usage information from the treatment process package. The electronic communication device included in the package may form part of a passive or active RFID system, in which case at least one RFID chip and antenna may be included in the package. RTLS or other electronic tracking and locating systems may be used as an alternative to RFID systems. Information may be passed between the treatment package and the database and processed by the processor in real time, which may allow you to conveniently provide assistance to the patient during the procedure via a smartphone or similar device, note that in some cases such devices forming part of a wireless communication network (such as Wifi or Internet) may also be configured to form a platform, which may also be used to communicate information and instructions to or from the package.

[0015] The platform, conveniently in the form of the above-mentioned packaging, may also include one or more analytical devices, such as microfluidic devices and related integrated circuits, which allow the analysis of the items contained in the packaging or the analysis of the environment around and including the packaging. Such analytical equipment can generally test diluents, injections or pharmaceutical compositions to check that they are safe in terms of chemical composition and dosage. When coupled with an electronic communication device, this can allow remote sensing and danger warnings to patients in real time, potentially. Such analysis can also provide information about the stability of the pharmaceutical composition, which can be matched with the packaging usage information to enable stability to be improved or to match the stability curve with the usage pattern of the packaging, which can reduce the cost of producing therapeutic packaging. In the case of a biosafety threat, the analytical device can determine whether the threat exists and whether the therapeutic packaging can be appropriately deployed to deal with the threat. This feature solves the following situation: the authorities may have enough knowledge to determine that the therapeutic package should be provided to the population, but there is not enough information about the scale and spread of the threat to recommend which population needs to use the package (noting that the drugs or other items therein have costs, and the packaging is wasted, and it is expected to prevent costs).

[0016] As described below, the computer system can also initiate a control response in terms of modifying the steps in the packaging manufacturing process so that the packaging includes the necessary therapeutically effective items to respond to the threat. In one embodiment, the computer system can control a machine or a manufacturing plant to produce customized packaging for the identified threat. For example, the computer system can control a 3D printing device or an injection molding plant to produce a package with a compartment and provide an article including an antidote corresponding to the treatment process to be performed. If it is a threat in the form of a mutant virus, the computer system may receive an information update from the computer system that stores data on antidote research and development, which may occur in real time in the case of a biosafety threat or other public health crisis. This allows real-time response to manufacturing capabilities and reduces delays in effective responses determined in the background discussion. This can include vaccines, such as vaccines developed using acceleration technologies as described in WO 2018176103, the contents of which are incorporated herein by reference.

[0017] A preferred portable therapeutic package of the above form is suitable for use in a therapeutic process, including the administration of a drug or vaccine by injection, optionally in a single or multiple episodes, and includes a container for containing a plurality of items required for the therapeutic process; and a plurality of compartments within the container, each compartment corresponding to a single item required for the therapeutic process, and ideally strictly corresponding, and including a compartment for containing at least one drug or vaccine. In this embodiment, the size of the container and the number of compartments within the container depend on the therapeutic process with a determined dose of the drug or vaccine. This configuration of the container is intended to ensure a safe dose during the therapeutic process.

[0018] Multiple items may be selected from any combination of the following, each of which is highly desirable to be housed in a dedicated compartment within the container: one or more ampoules containing diluents and / or injectables, one or more vials containing vaccines, including freeze-dried or "lyophilized" drugs and / or vaccines and / or reagents and / or diluents as known in the art; one or more needles or other suitable sharps, cannulas and syringes, and swabs that should be sterilely packaged, as well as specific sharps disposal equipment to ensure safe disposal of syringes and needles after use, and the treatment process packs can be conveniently disposable or configured for multiple doses.

[0019] Conveniently, the treatment package may include one or more vials, ampoules and cartridges for holding injections and / or diluents. In this case, one or more of the containers, vials, ampoules and cartridges for holding advantageously include sensors and / or electronic communication devices as described above, and also provide an "electronic safety net" for tracking containers and process packaging containing injections / diluents. To this end, the treatment process packaging, especially its container, may include at least one electronic communication device, which has an associated power source, whether it is a battery (disposable or rechargeable) or renewable, such as a photovoltaic cell. RFID chips and antennas may also be located in each vial, ampoule or cartridge for fixing the ampoule, conveniently contained in a compartment equipped with an RFID chip, which has a unique identification code, each of which can be used for tracking and at an earlier stage for the verification of items and / or to ensure that the correct items are placed in the compartment during the manufacturing process. The number and nature of the communication devices depend on the following factors: the information requirements of the computer system, the necessary level of accuracy required for the treatment process, such as the level measured by the SIL system and / or the degree of control required for the treatment process. Tracking data as described above, within the scope of a prescribed treatment or procedure, can be associated with patient and dosage information, usage and compliance, and used for injectable lifecycle management, safety, supply and inventory management purposes. Such data can be advantageously used to control and / or improve the efficacy of treatment packages and can be used as the basis for statistical process control of the manufacture, deployment and use of treatment packages. For example, where RFID tracking is used, in a public health emergency, it may be necessary to process data from multiple RFID chips or tags, which may pose identification problems. An anti-collision algorithm, such as binary encoding or other algorithm, for example, as described in "An Anti-Collision Algorithm for RFID based on An Array and Encoding Scheme", (2018) by Liu and Su, may be incorporated herein by reference.

[0020] The platforms and systems described above provide enhanced security in a variety of ways. By linking a communication device to a critical item contained or to be contained in a process package, such as an RFID chip or tag, the risk of counterfeiting critical items, particularly drug or vaccine ingredients, can be minimized and the authenticity of vaccines, drugs and / or reagents used in the treatment process can be guaranteed to a greater extent. The ability to increase control over the use of packaging also simplifies some logistical challenges and enhances security. In this regard, various codes, including blockchain codes, can also be used to process data and enhance the security of such information and the item authentication process. For example, the production and supply history of goods can be checked through blockchain ledger methods. In addition, verification and authentication of items contained in the packaging should also be increased. As described above, electronic tracking and data stored in computer systems have value and can be used as a form of currency.

[0021] Ideally, the container includes features that prevent improper use, packaging errors, and dispensing errors, particularly avoiding and preventing process packaging that contains an incorrect set of items for a prescribed treatment process. To this end, the multiple compartments of the container can be configured to contain only a prescribed set of items. For example, for a given container and treatment process, each compartment can be configured with a unique form that matches the items required for the treatment process. For example, a compartment may be configured only to accommodate and / or engage a specific size, color, form, or other form of an ampoule, vial; or a cartridge for accommodating an ampoule or vial. In the case where an item is attached to its compartment at the time of distribution, the attachment needs to match the shape, size, color, or other manner to the corresponding packaging compartment. For example, if a threaded attachment is used, the compartment with complementary threads will match the threads and size of the required item.

[0022] The container and disposal components of the therapeutic procedure package can be made of a suitable polymer or combination of polymers or other materials that can be conveniently manufactured in a cost-effective method (such as injection molding). The therapeutic procedure package can include packaging materials for maintaining the sterility of the contents until they are needed for administration to the patient. The therapeutic procedure package should also provide instructions for its proper use and written and / or other instructions, as well as a method for distributing other information and messages when necessary. This may also include any other materials that may be required or desired to be provided with the packaging and medication in accordance with government, program and regulatory requirements.

[0023] Methods of manufacturing such a portable therapeutic platform or package as described above form another aspect of the present invention. For example, the present invention provides a method of manufacturing a portable therapeutic procedure package for a therapeutic procedure, the therapeutic procedure including the application of at least one drug, and comprising: (a) a container for containing a plurality of items required to perform the therapeutic procedure; and (b) a plurality of compartments located within the container, each compartment corresponding to a single item required for the therapeutic procedure, wherein the container and compartments are made of plastic by injection molding and a tool for manufacturing the process package, the configuration and operation of which depends on the therapeutic procedure and a determined dose of the at least one drug. If at least one electronic communication device is included in the package, as described above, the computer system advantageously controls the manufacturing process to effectively respond to biosecurity threats or other public health crises based on information input received in real time from multiple platforms or packages.

[0024] The therapeutic process platform and system as described above addresses a range of health, packaging and logistical issues faced when administering a drug or vaccine in a non-therapeutic setting, as might be required in the context of a biosecurity threat or other urgent public health crisis, and does so in a safe and cost-effective manner. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] A more complete understanding of the platform and system of the present invention may be obtained through the following description of preferred and non-limiting embodiments of the present invention with reference to the accompanying drawings.

[0026] Figure 1 An isometric view of a platform in a treatment procedure packaging format according to one embodiment of the present invention is shown, the platform in a closed position.

[0027] Figure 2 Shown in closed position Figure 1 Isometric view of packaging for treatment procedures.

[0028] Figure 3 Shows Figure 1 and Figure 2 An exploded isometric view of the treatment process packaging.

[0029] Figure 4 It shows that Figure 2 and Figure 3 Side orthogonal view of the ampoule and cartridge shown.

[0030] Figure 5 yes Figures 1 to 3 Top view of the treatment process packaging.

[0031] Figure 6 yes Figures 1 to 3 and Figure 5 Isometric view of packaging for treatment procedures.

[0032] Figure 7yes Figures 1 to 3 , Figure 5 and Figure 6 A side cutaway view of a treatment procedure packaging.

[0033] Figure 8 yes Figures 1 to 3 and Figures 5 to 7 End section view of the treatment process packaging.

[0034] Fig. 9 A block diagram of a system according to an embodiment of the present invention is schematically shown. The system includes a reference Figures 1 to 8 One or more therapeutic procedure packages are shown. DETAILED DESCRIPTION

[0035] Reference now Figures 1 to 3 and 5 to 8, show a therapeutic procedure package 10 for a therapeutic procedure suitable for the administration of an injectable medication or vaccine. The medication may be, for example, insulin, for administration to insulin-dependent diabetics. The procedure package 10 includes the medical items necessary to conduct the therapeutic procedure. The skilled artisan will appreciate that the procedure package 10 is not limited to use in the treatment of diabetes, and that the procedure package 10 may be used to address many public health issues and as a countermeasure to threats such as biosecurity threats, as further described below. The therapeutic procedure package 10 is provided with written or other instructions for its use. The instructions may also include any other materials required to be provided with the medical device and medication in accordance with government regulations. The procedure package 10 may be equipped with a messaging system, such as a wireless text messaging system, such as Fig. 9 As shown, and described further below, it is enabled to receive communications via a communication channel 104 (which may be secure) from a control center managing the treatment process.

[0036] The process package 10 comprises a generally rectangular container 12 having a plurality of upward facing compartments 13, 14, 15 and 16 for containing the articles required for carrying out the treatment process, and comprises a syringe 20, a disposal device 30; a stopper 35; and ampoules 140A and 142A fixed in cartridges 40, 42. The number, spacing and size of the compartments are strictly determined by the articles, drugs and dosages required for the treatment process. Each compartment is separated from its adjacent partition by a wall or partition, i.e., walls or partitions 13A, 15A and 16A.

[0037] The container 12 has two compartments 13 and 14 that occupy most of the container 12. The compartments 13 and 14 are separated by a partition 13A. The compartments 13 and 14 accommodate a disposal device 30 for disposing of the syringe 20 and the associated needle after use, such as the disposal device described in Australian Patent No. 2001250170, the contents of which are incorporated herein by reference. The disposal device 30 has a syringe holder 32, a syringe barrel seal 30A and a needle seal 30B. The bottom of the compartment 14 includes an RFID chip / transmitter 17 that is assigned a unique identification code, the purpose of which is described below. The RFID chip / transmitter 17 can be included during the molding of the container 12.

[0038] For convenience, when manufacturing the treatment process package 10 and before use, the syringe 20 can be loosely packaged in the device 30, which is therefore used as a conveying device. The design of the syringe 20 is not important, and the treatment process package 10 is intended to accommodate various syringe designs. Remove the syringe cap 20A to allow access to the needle (not shown) for injection. The syringe 20 is intended to draw the medicine or vaccine and diluent (such as sterile water) contained in the corresponding ampoule 140A and 142A here. However, it is also possible to pre-fill the liquid required for the treatment process for the syringe. The syringe barrel seal 30A is cylindrical and can be neatly assembled through the partition 13A to prevent movement during transportation. The position of the syringe seal 30A deviates from the central longitudinal axis of the container 12.

[0039] The compartment 14 also houses two cartridges 40, 42, which hold the ampoules 140, 142 between the disposal device 30 and the wall of the container 12 with their sealing caps 140A and 142A, respectively. The ampoules 140, 142 are filled to a controlled volume to prevent overdosage or overdilution. The cartridges 40, 42 include cylindrical non-return sleeves that engage the ampoules 140, 142 by a bayonet fit, the diameters of the ampoules 140, 142 and the cartridges 40, 42 being selected accordingly. Three slots 40A are included in the cartridges 40, 42 to provide a non-return feature and to enable visual inspection of the ampoules 140, 142. Figure 4 This feature of cartridge 40 is shown. Due to the non-return configuration of cartridges 40 and 42, tampering and damage to cartridges 40, 42 will be apparent if replacement is attempted. Ampoules 140, 142 are preferably plastic, although in some cases they may be glass. The contents of ampoules 140, 142 are packaged under sterile conditions and remain sterile until sealing caps 140A and 142A are opened. Cartridges 40 and 42 have threaded portions 41 and 43, respectively.

[0040] Refer again Figure 4, each cartridge 40, 42 also includes an RFID chip 47 that uniquely identifies the cartridge and its contents via a unique identification code or tag known in RFID communication technology, and includes an antenna 47A that is minimized in a safe manner during the molding step at a location between the bottom of the ampoule 140, 142 and the bottom of the threaded portion of the cartridge. Figure 4 The location of the RFID chip 47 and antenna 47A is shown between the base 140B of the ampoule 140 and the base of the threaded portion 41. The RFID chip and tag arrangement will be the same for the ampoule 142 and the cartridge 42. The process package 10 includes a power source such as a battery to provide the necessary power for the RFID and other communications (if provided).

[0041] Even if tampering does occur, the RFID chip and transmitter 17, 47, 47A can track the container 12 and its ampoules 140 and 142. Tampering behavior has an abnormal pattern and can be detected by RFID tracking of the RFID system 47, 47A. Tracking provides data about use and transportation, which helps with medical compliance and inventory management. As mentioned above, it is critical to correctly match the items and containers used to perform the treatment process. RFID tags also allow the drugs stored in the ampoules 140, 142 to be authenticated before being included in the process packaging 10 during manufacturing, thereby enhancing medical safety.

[0042] RFID signal processing can also be used to control the manufacturing process. For example, the manufacturing process can include a computer control system that matches the RFID signal from the RFID chip / transmitter 17 for the container 12 and ampoules 140 and 142 and flags a fault if the signal does not correctly match the signal stored, for example, in a drug or vaccine supplier, regulatory or insurance database with the signal required for the specific purpose of the process package 10 (e.g., when the required procedure is vaccination, including insulin). Thus, incorrect packaging of drugs or vaccines can be prevented.

[0043] Compartment 15 is a container that allows the preparation or rehydration of the drug or vaccine with a diluent and can be omitted if it is not required for the treatment process. Since compartment 15 should be sterile, a dedicated insert or cover can be provided to achieve sterility. The size of compartment 15 cannot cause the drug to be overly diluted by the diluent. Compartment 15 can also be used to store other items, such as swabs, diluents, or other items required during the treatment process.

[0044] Compartment 16 is located in part 12A of the container, each compartment being screwed in with threads that match threaded portions 41 and 43 of cartridges 40 and 42. This allows cartridges 40 and 42 to be fixed in position in threaded compartment 16 for the preparation of a drug or vaccine solution. In some applications, this fixing can be done after manufacturing the treatment process packaging 10 and at a convenient point in the distribution chain. For example, in some applications, ampoules / cartridges can be supplied to patients in pharmacies or other collection centers. Can quickly check whether the correct ampoule / vial has been provided by checking whether the threaded portions of the ampoule / vial and compartment 16 are engaged. "Not suitable" means that a wrong ampoule or wrong process packaging 10 is provided.

[0045] All of the above items are packaged into container 12 under sterile conditions. Container 12 is made of a suitable polymer or a combination of polymers (although other materials, such as metals or alloys, can be used) and is manufactured by injection molding. Ampoules 140 and 142 and cartridges 40 and 42 are formed in separate injection molding steps to mold container 20. Ampoules 140 and 142 can be filled with large-capacity aseptic packaging machines, such as those available from Rommelag, Germany. Container 12 can have parts that are common to various applications, which is a useful feature for optimizing manufacturing costs and inventory management.

[0046] The treatment procedure package 10 is also provided with a lid 18 for the container 12, although a polymer or metal foil lid may be used instead. The lid 18 has a portion 18A that can be broken or torn to open the lid 18 and access the contents of the treatment procedure package 10. However, the lid 18 can be constructed in a variety of ways, including a sliding lid. The lid 18 can be reclosed at least during the treatment process. If desired, the container 12 can be further packaged. The container 12 is conveniently manufactured in large quantities and, once filled with items, has a shape that is convenient for packaging in a standard box or carton container, such as described above.

[0047] The patient may obtain the treatment procedure package 10 and perform the insulin administration procedure in the usual manner or as directed by another treatment procedure, for example, as described below with reference to Fig. 9 As the procedure package 10 is taken home, the container 12 allows for efficient and sterile transportation of items needed for the treatment procedure.

[0048] When the treatment process is to be performed, the patient folds down portion 18A of cover 18, removes the cover and accesses the contents of container 10. The process is performed according to the instructions accompanying the process package 10. Syringe 20 is removed and needle cover 20A is removed. Cartridges 40 and 42 are removed and inserted into compartment 16. Caps 140A and 142A are removed, and the contents of drug ampoule 140 are drawn into syringe 20. The contents of diluent ampoule 142 are then drawn into syringe 20 to form an injection. The patient or a patient assistant injects the injection. A diluent / disinfectant solution may be provided in compartment 15 for wiping. The use of syringe 20 is described for illustrative purposes. Any injection device and injection method, such as injection by intravenous injection, intramuscular injection or injection by bifurcated needle, will be within the scope of the present disclosure.

[0049] According to the procedure, the syringe 20 should be installed in the disposal device 30, and instructions can be provided for this. The ampoules 140 and 142 can also be stored in the container 12, which can then be reclosed with the cap 18 and disposed of in a safe manner.

[0050] The treatment process package 10 can also be applied to other treatment processes. Some processes involve diluting the drug with a diluent. By controlling the volume of the ampoules 140 and 142 by the size of the container 20, the treatment process package 10 is designed to ensure that the correct dose of the drug and the correct amount of diluent are provided. The RFID tags and management system described herein and the compartments for the drug and diluent ampoules and the RFID tags and management system provide additional assurance. This avoids dosage and diluent errors. For example, the correct amount of diluent can be 2mL. Then, the container 20 is designed to accommodate ampoules of 2mL capacity in only one of its compartments, such as one or two compartments 16.

[0051] The treatment process package 10 is designed through the entire process, and the vials, ampoules and cartridges suitable for the treatment process are designed in the container 12 to ensure that only the correct dose of injection and / or diluent and the corresponding items for performing the procedure are provided for each procedure. Another advantage is that a disposal device 50 is provided, which allows sharp objects to be safely disposed of in a technologically mature manner. The treatment process package 10 also serves to enhance the efficiency and method of injectable life cycle management and safe distribution. Once distributed, the treatment process package 10 also easily allows injections and sharp objects to be safely transported and stored.

[0052] Reference Fig. 9, a system 100 for managing the manufacture, deployment and use of multiple treatment process packages 10 is shown, each of which can be as described above. Each process package 10 has three RFID chips 17, 47 and 47A. As described above, RFID chips 47 and 47A have an important role during manufacturing. However, each chip 17, 47, 47A has a continuous use to track the location of the treatment package 10, each of which is assigned a unique identification code. In one option, the location of the RFID tracking information providing the treatment package 10 can be transmitted to a computer system 200 in a manner known in the field of RFID systems, and the computer system 200 controls the operation of the system 100 through a wireless communication channel 104. The computer system 200 can include a large computer or a large computer system and a personal computing device when necessary. Other forms of computers can also be used, and parallel processing is adopted where the amount of data and the processing required for the treatment package application are required. Multiple applications can be controlled by the computer system 200.

[0053] Tracking information showing at least the location of the process package 100 may be processed by the processor 210 in a variety of ways, and the information is also stored in a database 220, which also forms part of the computer system 200. With respect to the processing of information from the process package 10, this may involve identifying movement trends of the treatment process package 10. The processor 210 may map the probability and possible use of the location of the process package 10 in a particular area and correlate it with the health data of the area, wherein the deployment of the process package 10 is concentrated in the areas where the treatment process is most needed. In the case where the treatment process involves biosecurity threat countermeasures, the areas with the greatest threat may be determined and resources may be concentrated on the management of biosecurity threats in these areas. In the case where the nature of the biosecurity threat is uncertain, for example, bacteria, viruses or toxins generated from any of them, it may include assigning biological researchers to these areas. In the case where the process package 10 includes sensors of a "lab-on-a-chip" nature or microfluidic sensors, such sensors may identify possible threats, and such information may also be transmitted to the computer system 200 via the communication channel 104 and processed by the processor 210 to generate a control response. One control response may include modifying the production rate (indicated by arrow 310) of the process packages 10 produced by the manufacturing plant 300 through an injection molding process in response to the processor 210's analysis of the received sensor signals. Alternatively, where there are multiple manufacturing plants 300 in different geographic locations, the production rate may be modified based on the demand assigned to each manufacturing plant 300. Such control may be fully automated. Such statistical process control may be supplemented by processing of information by a processor using machine learning techniques to improve the manufacture and / or efficacy of the therapeutic packages as described herein while minimizing the cost of such deployment or indeed non-deployment, however measured.

[0054] The computer system 200 may also initiate a control response in the form of a request to a drug or vaccine manufacturing plant 400 to provide different amounts of the drug or vaccine to the manufacturing plant 300 based on demand. These manufacturing plants may utilize RFID comparisons between the RFID chips 17, 47, 47A of each package to ensure authentication and correct allocation to the process package, and multiple manufacturing plants 400 may be involved in the production of components such as vials, ampoules, and other items to be included in the process package 10. The production rate of such a manufacturing plant 400 may also be controlled in response to a demand signal from the computer system 200, which may be predicted by the processor 210 based on real-time or based on models developed based on previous similar epidemics or health crises. The potential scope of such health events is wide, but such careful coordination (most likely a multi-agency government response) is essential. To this end, in the case of RFID tracking, the need to carefully collect information, process and coordinate responses, and process data from multiple RFID chips or tags (17, 47, 47A, some of which may be separate) potentially poses identification and processing problems. Thus, the computer system 200 may implement an anti-collision algorithm such as binary encoding or other algorithms as described by Liu and Su in “An Anti-Collision Algorithm for RFID based on An Array and Encoding Scheme”, (2018), the contents of which are incorporated herein by reference.

[0055] System 100 also allows biological research center 500 to participate, which can analyze sensor signals from computer system 200 as described above. In the case where biological or other agents have not yet been identified and antidotes may need to be developed, this input may be important. In the case where the reagent is, for example, a mutant virus, this input may also be important. Processor 200 can send data including real-time data to research center 500, and can be used to develop antidotes, in particular, vaccines developed by the accelerated technology described in, for example, WO 2018176103, the contents of which are incorporated herein by reference. Such information is particularly important when designing and manufacturing appropriately configured process packaging 10, especially the construction of the required therapeutically effective articles included in process packaging 10 and the compartments in container 12 to accommodate the articles in process packaging 10. Therefore, research center 500 also sends data and even control signals to packaging manufacturing plant 300 and therapeutically effective article manufacturing plant 400 to optimize production and minimize cost and waste. The system allows real-time response to manufacturing capabilities and reduces delays to effective responses determined in background discussions.

[0056] The system 200 may involve the use of a wireless communication network, wherein the treatment process package 10 includes a suitable electronic communication device, such as included in a laptop, smart device or cellular phone. A USB or similar download from the treatment package 10 may also be provided. Although a wired network is also feasible for communication between the manufacturing plant 300, 400 and the research center 500, the computer system 200 may be connected to the manufacturing plant 300, 400 and the research center 500 via such a wireless communication network. Due to the sensitivity of the data, a secure wireless (or wired) communication network may be required, especially in situations where anonymity is not possible, and due to potential national security risks, wherein the system 200 is used to respond to public health emergencies or as a countermeasure to biosecurity threats.

[0057] For ease of explanation, the wireless communication network channel is Fig. 9 104. In the case where the process package 10 allows for the sending and receiving of messages, the computer system 200 can send instructions to the process package 10 (or a mobile phone or other communication device associated therewith), including but not limited to instructions to open the process package 10 or indicate when the package needs to be used. For example, and as described above, the process package 10 can be issued to protect the population from possible biosecurity threats. However, the relevant authorities may not yet have evidence that the public must use the process package 10 for protection. When such evidence is received, instructions can be issued for the population or one or more segments of the population, which are determined by geographic location or as described above by the processing of the use data by the processor 210 of the computer system 200. Such instructions are most conveniently sent from the computer system 200 to each process package 10 via a wireless communication network, especially in the case where a mobile phone cannot be associated with the process package 10, for example, the treatment package 10 can be activated by providing access to the process package 10. This allows for a higher precision in the treatment response to the threat and avoids the expensive and potentially risky use of the process package 10, and it is highly desirable to minimize such costs.

[0058] In another embodiment, the computer system 100 may also initiate a control response in terms of modifying steps in the packaging manufacturing process in the manufacturing plant 300 so that the packaging includes the necessary therapeutically effective items to address the threat. For example, the computer system 100 may control a 3D printing facility or an injection molding plant to produce a process package 10 with the required compartments and items corresponding to the therapeutic procedure to be performed. These items may include an antidote for a biosecurity threat.

[0059] The computer system 200 can also control the logistics of deploying the package 10 to the target population, for example, by controlling the operation of an autonomous vehicle, robot, drone, or similar computer-controllable means of transportation, which is particularly advantageous in situations where the threat is highly contagious, such as in the case of a viral infection.

[0060] A skilled reader of this disclosure will appreciate modifications and variations of the platforms and systems described herein. Such modifications and variations are considered to be within the scope of the present invention.

Claims

1. A method for managing a portable therapeutic package for a therapeutic procedure, comprising the steps of: (a) providing a plurality of therapeutic procedure packages, each of said therapeutic procedure packages comprising at least one therapeutically effective article required for conducting a therapeutic procedure; and at least one electronic communication device having a unique identification code for receiving and transmitting information regarding the environment surrounding and including each said therapeutic procedure package; (b) communicating information regarding the environment surrounding and including each said therapeutic procedure package between an electronic communication device of each said therapeutic procedure package and a computer system including a processor, said processor processing said information regarding said environment; as well as (c) initiating an automatic control response while processing said information transmitted from said plurality of therapeutic procedure packages to said processor; wherein said at least one electronic communication device of each said therapeutic procedure package is in communication with said computer system such that information is communicated between each said therapeutic procedure package and said processor of said computer system; Wherein, processed information from a plurality of said therapeutic procedure packages enables statistical process control of at least one of manufacturing said therapeutic procedure packages and deploying said therapeutic procedure packages to a population in response to a biosafety threat or other public health crisis.

2. The method of claim 1, wherein: The statistical process control is a response to biosafety threats or other public health crises.

3. The method according to claim 1 or 2, wherein: The electronic communication device communicates with the computer system via a wireless communication network such that information and / or instructions are communicated between the treatment procedure package and the computer system.

4. The method of claim 3, wherein: The information includes information regarding the use of each of the treatment procedure packages, including information from sensors that detect when, how and / or where the contents of the package are used.

5. The method of claim 1, wherein: The processing of information by the processor through the use of machine learning techniques supplements statistical process control to increase the efficiency of deployment of the therapeutic packages while minimizing the cost of such deployment or non-deployment.

6. The method of claim 1, wherein: The therapeutic procedure package includes at least one compartment for containing the therapeutically effective article.

7. The method of claim 1, wherein: The therapeutically effective substance is a drug.

8. The method of claim 7, wherein: The therapeutically effective article is an injection.

9. The method of claim 7, wherein: The therapeutically effective article is a vaccine.

10. The method of claim 7, wherein: The at least one electronic communication device is a tracking device that provides tracking data as a basis for performing said statistical process control over the manufacture and deployment of a plurality of said therapeutic procedure packages.

11. The method of claim 1, wherein: At least one of the plurality of said therapeutic procedure packages includes at least one analytical device that allows for analysis of the environment surrounding said therapeutic procedure package.

12. The method of claim 11, wherein: The processor determines whether to use a further treatment package having a modified configuration to combat the viral threat in a control response based on the analysis of at least one of the analysis devices.

13. The method of claim 1, wherein: At least one of the electronic communication devices comprises a device forming part of a passive or active RFID system, at least one RFID chip and an antenna included within the treatment procedure packaging.

14. The method of claim 13, wherein: The RFID system is capable of detecting tampering with the treatment procedure packaging.

15. The method of claim 1, wherein: The therapeutically effective articles include drugs for treating diabetes.

16. The method of claim 15, wherein: The drug is insulin.

17. A therapeutic procedure package administered by the method of claim 1.

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