DE202005008379U1 - Assembly for the preparation of diagnostic or therapeutic substances, with a short life, has a therapy module with at least two vessels and a system to transfer at least part of the substance from one vessel to the other - Google Patents

Abstract

Therapy module (1), for the preparation of a diagnostic or therapeutic substance compound, having at least two vessels which are interconnected, is new. The vessels hold at least one substance, and a system transfers at least a part of the substance from one vessel to the other. Therapy module (1), for the preparation of a diagnostic or therapeutic substance compound, having at least two vessels which are interconnected, is new. The vessels hold at least one substance, and a system transfers at least a part of the substance from one vessel to the other. The assembly is fitted with pumps, dosing and/or sensor units. The system has a base module (2) with a holder (3) to take the therapy module, a module (4) for the active substance and a transfer module (5), linked together by interfaces to move the active substance into the therapy module and/or from the therapy module to the transfer module. The modules are shrouded against radioactivity and/or the escape of substances.

Description

The The present invention relates to a system and components for providing a diagnostic or therapeutic substance compound and in particular for providing a substance containing a short-lived substance diagnostic or therapeutic substance compound.

at certain treatments, i. therapeutic and diagnostic Applications become diagnostic or therapeutic substance compounds used, the short-lived substances punch, such as short-lived chemical substances, living cells, proteins or radioactive substances.

For many, ephemeral substance treatments can essentially be a short-lived substance generally valid Scheme of process steps from patient diagnosis to the administration of a drug and the final one Diagnosis of the performed Therapy be set.

typically, include the process steps after a diagnosis and decision for a particular treatment and the corresponding planning the production of a drug by merging several for the treatment needed and developed substances, the quality control of the manufactured Drug, the transfer of the Drug into a dosage form and the administration of the drug.

in the Framework of the treatment established by patient diagnosis are data, such as the constitution of the Patients, the clinical picture, the expression of genetic expression certain targets and thus the applicability of certain targeted ones Forms of treatment, the type and strategy of treatment, frequency and frequency the treatment and the individual doses to be administered Medicines or diagnostic substances as well as the necessary Control and aftercare generated.

These So far, data is usually recorded "manually" and, if necessary, on a computer saved patient records stored.

When Next Step, the preparation of the starting materials or substances for the Medicament, for example, chemically and / or biologically short-lived or radioactive sources, but also others, in time comprise essential stable biological or chemical substances can. Especially Radioactive isotopes are usually used by different manufacturers and often manufactured in research institutes, for medical applications high demands on the chemical and radiochemical purity be put and production due to legal regulations under environments according to cGMP standards or take place using comparable methods and manufacture quality monitored and must be documented.

isotope with half lives in the range of several days or weeks delivered directly in containers while Isotopes with shorter ones Half-lives only on site with the help of an accelerator, reactor or can be obtained from generators that are radioactive Containing parent isotope and the disintegrated, desired daughter isotopes on physicochemical To provide a route.

by virtue of radioactive decay, the resulting radiation dose as well as the resulting balance between mother and mother Daughter isotopes are those available from the generator systems Quantities of radioactive isotopes are usually limited. by virtue of temporal variability these substances as well as others for the production of medicines used, time-varying Substance is an exact planning of the treatments in the sense of an optimal Exploitation of available necessary radiation dose necessary.

The Preparation of temporally substantially stable, biological and chemical precursors necessary for the manufacture of a drug may also be necessary is usually done according to the conventional Pharmaceutical Technology. Since the expiration times regarding the quality and sterility of this Substances significantly over the half-lives of the isotopes used or other chemically or are biologically unstable substances, is a sufficient Inventory and timely reordering unproblematic.

The necessary for the preparation of the drug combination of starting materials as well as the binding or incorporation of isotopes or other temporal unstable substances in the drug usually takes place by means of biochemical and physical procedures in the laboratory of a clinic instead of. The biochemical processes for the preparation of the drug are usually performed manually by the clinic staff. This requires a high level of concentration, practice and Speed and thus total training, with the necessary quality and safety a highest possible yield a radioactive isotope or another time-instable To achieve substance.

The currently common approach, however, means high losses of temporally unstable substances due to lack of time coordination and the short life of this Substan Zen. Often it is due to the only manual data collection to a poor integration in a quality monitoring. Furthermore, the currently common practice in which radioactive or toxic substances are handled manually means a high radiation and also toxic load and thus safety risks for the staff.

To The production of a drug is necessarily a quality control required, with the e.g. it can be ensured that a harmless Limit for radioactive isotopes was exceeded and no toxic and proinflammatory Substances are present. Furthermore, the exact one must be the patient be administered dose to be administered.

To the transfer of the Medicament in a dosage form immediately before the administration of the Drugs are currently being used in several ways, such as the waste in a container, out which in turn filled syringes be, the direct bottling in syringes used by the doctor, direct application by means of Catheter or needle and the direct production of ingestible Containers, such as tablets or capsules. In many cases will the drug is filled in a glass jar, placed over a Septum is emptied. According to common practice, these too Steps done manually.

at the above-described process steps for the production and applying a medicament containing one or more ephemeral substances according to the state There are several disadvantages summarized below in the art.

The in the patient diagnosis resulting data, all required including diagnostic and therapeutic measures Type and extent of treatment with all the drugs needed, the radiation dose and mode of administration are so far only detected manually and in Filed patient records. A connection or feedback between the diagnosis and the manufacture of the drug is either not at all or only in the Framework of individually created and tailored to individual clinics Systems.

by virtue of the manually detected and therefore often Lack of data base is currently a high cost in the Therapy planning and capacity planning. However, all data collected in patient diagnosis have the untapped potential, for production planning, logistics planning, control of the manufacturing process with regard to the required quantity, Concentration and quality as well considering the treatment planning the restrictive Conditions in the clinical setting. A simple change of the treatment plan during preparation time, such as taking into account the change the constitution of a patient, is in the current course of action difficult to carry out.

Regarding the Manufacture and supply of short-lived components of a drug exist Deficits due to the between the manufacturers and the clinics currently or only insufficiently existing agreements on the Purpose and the required quality standards of delivered Products. The manufacturer usually has no comprehensive knowledge of the needs the individual therapies.

Recorded quality data insufficiently involved in the production of the drug. In the The rule is the employee working in the clinic laboratory responsible for it responsible, to consider this data appropriately.

The Logistics chain in terms of required quantity and quality as well automatic reordering is not closed, in general not nationwide standardized and too slow overall. Therefore, ordering times are for the Substances of several weeks the rule.

by virtue of The manual documentation is usually the quality control of the drugs produced only to an insufficient extent instead of and designed due to the short half-life of the drugs very difficult.

at the administration of the medication occurs despite the use shielding a relatively high radiation exposure. By the for the staff allowed Total radiation exposure will again be the number of single doses, which can be prepared and administered at a time interval. The administration of the correct dose is currently the responsibility of the staff and a comprehensive, error-free quality assurance is not guaranteed.

It Therefore, the object of the present invention is a system as well Components thereof for providing a diagnostic or to provide therapeutic substance compound with which the Disadvantages of the prior art reduced or overcome can be and with the one concerning the cost, quality assurance and documentation improved production of compound compounds or drugs and especially those that are unstable in time Contain substances can be achieved.

These Task is solved with a therapy module according to claim 1, a base module according to claim 7 and a system according to claim 14th

According to the invention is a Therapy module for providing a diagnostic or therapeutic Substance compound provided comprising at least two together connectable containers for receiving at least one substance and agent or part a means for supplying a Quantity of at least one substance from one of the containers in another container of the therapy module.

The inventive therapy module is suitable for storage, delivery and provision of a or more preferably temporally substantially immutable Substances and further includes a container in which substances directly before administration to a patient, and more particularly to a patient Clinic with one or more, especially temporally unstable and possibly from the outside supplied Substances can be brought together or united. It is conceivable, the therapy module at least partially reusable or as a disposable product. The means of delivery of Substances from one of the containers in another container of the therapy module has the function of mixing the substances between the containers to transport, However, it can also be used to dose the substances and to control the amount of an optionally supplied from the outside further substance used become.

Of the chemical / physical structure of the therapy module including reservoirs, Pumps, other components or parts thereof can by means of suitable manufacturing methods as a block or made Standard components are built. Furthermore, suitable Coatings on the insides of the components used Be used to the dosage, quality assurance and if necessary to influence ongoing reactions.

The inventive therapy module thus forms a cost manufacturable, for a variety of substance compounds usable, empty, partially or completely befalls available device for the production of a diagnostic or therapeutic Substance compound immediately at the site of administration to a Patients, whereby temporally variable, physically, chemically or biologically unstable or radioactive Substances can be added immediately before administration, so that one in terms of the state of time-varying Substance or the radiation dose controlled production can be done in a substantially automated way and a contamination of persons, e.g. by clinical staff or in the laboratory is largely avoided.

at the prepared or administered substance compounds can thereby all medical and health requirements regarding the security for the patient, stability and biological or chemical half-life, in particular if they contain temporally unstable starting substances, are complied with.

According to one embodiment the therapy module has several containers, of which at least a container directly with at least two other containers of the therapy module connected is. Furthermore, at least one of the containers at least one access, in particular for a sensor means, in particular to carry out quality assurance Activities, or a mechanical interface to the outside of the therapy module exhibit. Preference is given by all manufacturers of basic substances and therapy modules uses a substantially unified form, in the certain specifications, such as the dimensions and the place of access adhered to the therapy module and other features of the structure, such as. the number of containers contained in the therapy module and their arrangement as well as the number and type of therapy module provided technical components are variable.

According to one another embodiment the therapy module one or more at least one container associated Pumping means, dosing agent as a means for supplying a quantity of at least a substance from one of the containers in another container of the therapy module and / or sensor means or parts thereof. Be only parts of the dosing agent, sensor means and / or a pumping means provided in the therapy module, and other essential Parts of these funds outside and in one, reusable with a variety of therapy modules Shape, can the manufacturing costs of the therapy module are lowered, is for the therapy module only a smaller space needed and show the individual Therapy modules only a smaller probability of failure on.

According to a further embodiment, the therapy module comprises a housing in which the containers are received, and lines, by means of which the containers are connectable to each other. As a result, contamination of persons involved in the handling of the modules by substances contained therein can be avoided. However, it is also conceivable that some or all containers directly, ie without additional lines with each other are connected.

According to one more another embodiment the therapy module is externally controllable and has means for receiving of control and / or power signals for the funds to the feeder an amount of the at least one substance from one of the containers in another container the therapy module and / or for a sensor means. Thereby can expensive control equipment and the external power supply provided and used several times.

According to the present The invention further provides a base module for providing a provided with a diagnostic or therapeutic substance compound, the one recording for a therapy module and means for controlling one or more am Therapy module provided means for supplying a quantity of a substance from one of the containers in another container the therapy module and / or one or more sensor means, in particular to carry out quality assurance measures includes.

The Basic module serves primarily the preferably automatic Controlling the production of a substance compound in a therapy module, wherein In principle, it can be reused as often as desired and with one Variety, possibly of different drug manufacturers and Suppliers may be provided with one or more basic substances Therapy modules can be coupled. By using the base module according to the invention in Connection with one or more therapy modules is as far as possible automatic, non-contact and controlled parameter production of compound compounds possible, in particular temporally unstable substances at the location of the base module, which is preferably chosen close to the site of administration, directly in the production the substance compound and before the administration of the drug added in a controlled way can be.

According to one another embodiment the base module comprises means for detecting at least one parameter the group comprising the type, quantity, temperature, radiation dose, the radiation spectrum, the remaining life, in particular one short-lived substance, residence time, concentration and pH at least one substance contained in the therapy module. This allows a controlled production and quality assurance the substance compound or medicament produced in the therapy module respectively. Such means can additionally or alternatively be provided on other modules.

The Basic module has according to a another embodiment a data processing unit for process control and a data storage means on. This allows management and storage of the base module detected Data, in particular concerning the parameter of the preparation of the drug or the substance compound used substances at the time of manufacture, as well as externally supplied Data, such as of patient data as well as the entire therapy and capacity planning done in the base module. The base module can meet quality requirements for the produced Substance compounds also supplied with external "quality data" from central databases become.

According to one another embodiment be provided that the Basic module Means for controlling the supply of a substance in the Therapy module from outside, such as. having one or more pumping or dosing. Further the basic module may be means for controlling one or more accesses or Have interfaces of the therapy module. This can still be done not contained in the therapy module for the preparation of a substance compound required substances and in particular temporally unstable substances at the site of the basic module in controlled quantity and controlled State added become.

According to a further advantageous embodiment, the base module comprises at least part of at least one pumping means, dosing means, sensor means and / or evaluation electronics of the sensor means provided in the therapy module. By dividing drive, control and power supply units between the therapy module and the base module, such as by providing a pump head in the therapy module and a pump motor in the base module, a piezo pump in the therapy module and the corresponding electronics in the base module, a sensor head in the therapy module and corresponding evaluation In the base module, the cost of the preferably prepared as a disposable product or in parts reusable therapy module can be reduced, the therapy module can be made with a smaller space and a lower probability of failure of the therapy module can be effected. It is particularly desirable to arrange the largest possible part of the technical components in the reusable base module. However, a prerequisite for such a division of the components is the use of standardized therapy modules that are standardized to a certain degree, so that all therapy modules, if any, supplied by different manufacturers can be used on a base module. For example, it is conceivable that the access to technical or connections for technical components in all therapy modules to the same Provide locations so that parts of these components contained in the base module are compatible with the therapy modules. On the other hand, it is not necessary that the same components or the same number of containers are provided in the therapy modules.

According to one another embodiment the basic module can be coupled to a computer or computer network. About one corresponding network connection can provide quality data, Patient and therapy data as well as data for process planning communicated and a remote maintenance can be realized. From base and / or therapy module detected or provided quality, Manufacturing, identification and monitoring data can also be accessed via this Network connection communicates be or over suitable data storage such as a memory card or a writable RFID chip for provided an external use.

The Base module may further be for power and / or control of provided in the therapy module and / or other modules electrical Serve and include components Furthermore, if necessary, an operator interface, such as a keyboard and / or a touch-sensitive Screen, over an input and display of data can be done. Furthermore, the Basic module next to a docking option, such as a mechanical interface for the therapy module additional interfaces for have other modules.

One Another important aspect of the base unit according to the invention is that she is preferably designed so that they at no time with Substances is contaminated and the chemical / physical processes exclusively take place in the therapy module and / or other modules. An avoidance a contamination of the base module by substances on the one hand be achieved by a or several modules containing at least one substance directly with be connected to the therapy module. However, it is also conceivable one or more modules containing at least one substance, to couple to the base module, but these modules designed so are that one direct connection with each other or with the therapy module is possible, so that substances without contamination of the base module between these modules promoted can be. The interface of the modules with the base module can, for example to power the modules or to make control connections for one Control of connected modules used by the base module become.

According to the invention is the another system comprising a therapy module and a base unit provided. The system may further comprise an active agent module or Isotope module for storage and / or manufacture physically, biologically or chemically short-lived substances, such as radioactive isotopes.

Of the modular construction of the system according to the invention has various Advantages. The preparation of the substance compound takes place locally the installation of the base module, i. preferably in the clinic, and preferably under quality control by the base module. Thereby can the medication to be given to a patient immediately before the administration are made individually and patient-friendly, even short-lived substances are effective and without the need a consideration can be added by already completed decomposition processes. The Production takes place without substances come into contact with persons, essentially automatically under Control by the base module, but depending on the individual Therapy planning as well as those contained in the therapy module or by Outside added Substances completely different substance compounds under qualitative and quantitative control. Through the system can a comprehensive monitoring and optionally controlling the manufacturing and / or therapy process including a quality control and feedback to the suppliers of the modules and substances.

The inventive system allows the effective and flexible handling a variety of in time variable Substances and in particular radioactive isotopes in a variety of pharmaceutical applications and prevents bottlenecks Supplying with or providing the time variable substances and in particular of isotopes, while maintaining quality control in the manufacture and safety aspects in the production and Administration of compound compounds can be improved.

Due to the modular design, the reusable valuable or expensive technical means, such as quality assurance facilities, means for dosing substances, means for determining parameters of the substances, drive means, power supply devices and / or computer, processor and data storage means at least partially in the reusable base module be arranged, while the storage of particular temporally substantially invariable, ie storable substances and for the production of individual substance compounds serving therapy module, preferably as a disposable article or at least partially recyclable can be performed. The base module may also be used to manage therapy data, such as patient data and treatment history, as well as quality data production, identification, and monitoring data.

A Interface of the base unit can in the longer term by the active agent module be occupied, the production or storage of short-lived, i.e. biologically or chemically unstable as well as radioactive substances serves and can be temporarily filled by a manufacturer, so that the active agent module only has to be coupled to the device in the clinic. Also the active agent module can be made exchangeable or recyclable preferably a part of the technical components, such as. for the removal of substances from the active agent module or for measuring parameters of the substances contained in the base module can be provided.

According to one another preferred embodiment comprises the system has a transfer module for storage and transportation one or more substances or substance compounds, wherein the Transfer module Means for dosing a quantity of substance or Substance compound in dependence from the already decaying substance portions of the one substance or substance compound.

The Transfer module is used i.a. the transport of the substance compound produced from the therapy module to the patient for administration and may be attached to a certain application form, such as the shape of a Syringe, a catheter or a needle adapted.

Preferably the transfer module has means for performing a patient authentication, to ensure a clear assignment to a patient and to avoid confusion.

According to one another embodiment are the therapy module, the active agent module, the base module and / or the transfer module by means of mechanical, in particular sterile interfaces connectable with each other. Furthermore, the system can provide means for Transport of substances from the active agent module in the therapy module and / or from the therapy module into the transfer module without the base module contaminated. Some or all interfaces may be further connectable without leaks and dead volumes or executed separated from each other become. An easy way for its realization consists in the use of a septum (rubber disc), which is pierced with a needle. An alternative, technical but more complex solution provides a self-closing coupling dar. To avoid confusion when connecting modules, can suitable identification solutions be provided, by means of which a module clearly identified can be. This can optically by means of a bar code, radio technology by means of an RFID chip or tactile contact by means of integrated Memory elements or by a form identification or the like. respectively.

The above for receiving one or more substances Modules, i. the therapy module, the transfer module and / or the active agent module, can either directly connectable to each other or to the base module can be coupled be. In the latter case, some or all are for taking one or more substances configured modules preferably designed so that she for transportation of substances are directly connectable to another such module, without that Base module to which they can be connected is contaminated. These can be the Modules e.g. a finger or have tubular portion. On the other hand, the basic module at the interfaces provided for connection to these modules preferably with a passage provided and may be for power and / or control serve the connected modules.

According to one Another embodiment, the Therapy module, the active agent module, the base module and / or the Transfer module a shield against radioactive radiation and / or a have the outlet of substances preventing structure. Thereby contamination of the clinic staff can be avoided and the number of single doses administered and the number of treated Patients increased become.

Preferably If the active agent module is produced with a standardized shape, that of a variety of drug or isotope manufacturers and Suppliers can be used. This can be a nationwide and geographically unlimited standardized supply of active substances be achieved.

It can thus be a diagnostic or therapeutic substance compound by providing a therapy module with at least one first and a connectable second container and at least one in the first container absorbed substance, arranging the therapy module to a base unit, Respectively a quantity of the at least one substance from the first container in the second container of the therapy module under the control of the base module and supplying a Amount of another substance to be provided in the second container.

In order to are the advantages of a largely automated and under controlling the parameters of the substances used Preparation of a substance compound under the control of a given central unit.

Further the other substance may be covered by a third of the therapy module and with the second container connectable container be supplied. In the therapy module can For example, be contained several substances whose storage is not a problem and that are not subject to any short-term changes.

A however, further substance can also be supplied from outside to the therapy module. This is especially in short-lived chemically and / or biologically unstable Substances or radioactive substances of advantage, since these are immediate before the administration of the drug can be supplied, wherein before that there were changes of the substances as well as decays not considered Need to become, because the state of the short-lived substance immediately upon delivery to the Substance compound can be determined. Furthermore, the required quality control immediately at the time of manufacture of the drug on the spot performed in the clinic become.

Further can several different in several containers of the therapy module contained substances in one with the multiple containers directly connected container of the therapy module become.

Of another one can be related at least one of its properties temporally changing substance in the therapy module supplied and at least one parameter from the group comprising the Type, quantity, temperature, radiation dose, the radiation spectrum, the remaining lifespan, residence time, concentration and PH value, the fed into the transfer module Substance detected become. As part of a quality assurance measure, parameters the substances contained in the substance compound before or after their merging be determined. These data are preferably in a preferably stored in the base module data storage unit and can in considered an automated process control become.

Furthermore can be a short-lived, especially chemically or biologically unstable or radioactive substance are fed into the therapy module.

Also can at least one substance from the therapy module into a transfer module supplied become. The transfer module is used to transport a manufactured Substance compound to the patient and may be a means of dosage the right amount depending of decomposing substances contained in the substance compound include. Furthermore, it may be due to the form of application, such as a syringe, a catheter, a needle, be adapted. Furthermore, can the transfer module with a means for identifying a patient be provided to ensure proper allocation and confusion to avoid.

Further can Substances from and into the individual modules under the control of the Base module supplied become. The modular design of the system, with important control tasks executed by the base module serves to control the process flows and collect the data, so that one largely complete Automation can be achieved and changes to process flows easily can be made.

Of Further, a computer can be provided, which is set up is, the system of the invention respectively.

The inventive therapy module, the base module and the system can for a variety of therapeutic and diagnostic purposes be used. Particular preference is given to applications in this case which is a preparation of a therapeutic or a diagnostic substance compound near the site of administration, such as in a clinic, from Advantage is.

exemplary Applications include the administration of radioactive nuclides (radioisotopes) comprehensive substance compounds, for example, for treatment and Diagnosis of cancer, in pain therapy, as well as in wound treatment. In this case, preferably isotopes with suitable half-lives and dose rates and as possible used short ranges.

at enable diagnostic applications Isotopes the visualization of metabolic processes and localization of cell types. For this, the isotopes are incorporated into molecules, participate in the metabolism, or coupled to antibodies and similar proteins, which in turn are bound to specific receptors. For one preferably low burden on the patient are hereby small dose rates and a very short half-life of a few hours or minutes sought.

For diagnostic Purposes can Furthermore, radioactive substances for PET tomography, X-ray or CT examination or even fluorescent substances used become.

All by means of the system according to the invention Substance compounds produced must be the drug and meet health-technical requirements. This means that in particular chemically or biologically unstable starting substances after their connection with other substances after the manufacturing process a stable, must result in safe and logistically manageable substance compound.

The modular according to the invention System as well as individual components of the same are hereafter based on an exemplary embodiment explained.

The FIG. 1 shows schematically the integrated radiopharmaceutical according to the invention Product Quality Assurance Security System (IQS) according to a Embodiment.

The system shown in the figure comprises a therapy module 1 with at least two containers (not shown) connectable to each other for receiving at least one substance and one or more agents, in particular pumps or dosing agents, for supplying at least one substance from one of the containers to another container of the therapy module 1 or at least parts of these funds. The therapy module includes interfaces 7 . 9 to individual containers or modules and may also include one or more external accesses (not shown) for delivery of substances or introduction of sensor means.

In the therapy module 1 It is also possible to provide a plurality of containers provided for receiving basic substances and at least one further container, which is connected directly to at least two other containers and for producing a substance compound in the therapy module 1 is used. The internal structure of the therapy module, the number of containers contained therein and their connections, the number of pumping means and / or sensor means may vary with different therapy modules. The dimensions of the therapy module are in principle variable, although a size corresponding approximately to a video cassette is preferred. The therapy module preferably has the shape of a cuboid with a side length of preferably less than 20 cm, more preferably less than 5 cm, a width of preferably less than 10 cm, particularly preferably less than 2.5 cm and a height of preferably less than 5 cm and more preferably less than 1 cm.

The therapy module 1 or the chemical / physical structure contained therein, optionally including reservoirs and pumps, is produced by means of suitable production methods as a single mono-block or constructed with standard components. Suitable materials for the production of the base module and in particular of the containers and of lines to their connection include plastics, metals, in particular oxidation-free metals and glass or combinations thereof. Furthermore, suitable coatings can be used on the insides of the components used to influence the dosage, quality assurance and ongoing reactions.

Furthermore, the system comprises a base module 2 with a recording 3 into which the therapy module 1 can be introduced. The basic module 3 includes a control panel 6 , via which parameters for the control of processes can be entered and optionally recorded data or process sequences can be displayed. According to the embodiments shown, the base module 2 furthermore preferably at least one part of drive, energy supply and sensor means (not shown), in particular for quality assurance, for the therapy module 1 on, such as one or more pump motors for possibly provided in the therapy module pump heads and a control and evaluation for possibly arranged in the therapy module piezo pumps or sensor heads. Optionally, the sensor means also completely on the base module 2 be provided.

The sensor means may comprise means for acquiring parameters of the therapy module 1 and substance compounds produced, such as, for example, the amount, the temperature, the radiation dose, the radiation spectrum, the remaining lifetime, the residence time, the concentration and the PH value. This allows the base module 2 Quality or state characteristics of the substances or the substance compounds detected and can be carried out a quality assurance of the substance compound.

Prefers Be non-contact Sensor means used, such. Detectors for radiation measurement, Means for measuring the refraction of light u.a. for determining the presence and the kind of a liquid, Photocells for determining the presence of solids, Means for measuring color changes, in particular for the detection and detection of the course of chemical Reactions.

Other Sensors include gamma, beta sensors, borehole scintillation counters, HPLC columns, CCD and video cameras Etc.

By providing these reusable components in the base module 2 and not in the therapy module 1 can reduce the manufacturing costs of the therapy module 1 can be reduced therapy module 1 with smaller dimensions and features the therapy module 1 a lower probability of default. The basic module 2 can be used in a variety of therapy modules 1 be used, which may differ in their construction.

Due to the modular structure comes the base module 2 at no time with the substances or substance compounds in contact and the expiring processes take place exclusively in the therapy module 1 possibly with the involvement of other modules. Also persons involved in the preparation and administration of the compound of substance do not come in contact with the substances.

The basic module 2 further preferably includes an information system preferably comprising a processor for storing data, for linking data, for example, for therapy and capacity planning and / or for displaying the technical status of individual modules. Furthermore, the basic module offers 2 further preferably an access 8th to a local or global network, such as the Internet, so that data from other involved components, such as drug manufacturers, can be included in the process control and from the base module 2 collected data can be sent to drug manufacturers or other users.

The basic module shown in the figure 2 is merely exemplary and could also have a modified structure or another form. In particular, the recording 3 for the therapy module 1 could be designed so that therapy modules 1 different size or multiple therapy modules 1 can be connected at the same time.

As can be seen in the figure, the system further comprises an active agent module 4 , preferably by means of a further interface to the base module 2 or directly to the therapy module 1 can be coupled. In the embodiment shown, the active agent module 4 to the base module 2 coupled. So that the base module 2 is protected from contamination by substances, has the active agent module 4 on the for the connection to the base module 2 provided side a finger-like portion (not shown), which in one of the base module 2 provided and to the therapy module 2 leading (not shown) opening or implementation can be introduced and directly with the therapy module 2 is connectable, so that substances without using the base module 2 to be able to be transferred.

The active agent module 4 serves the storage or production of chemical or physically unstable or radioactive substances. The active agent module 4 is preferably secured against leakage of toxic substances or provided with a radiation shield. The from the active agent module 4 taken short-lived substances are immediately and under the control of the base module 2 in a container provided for the preparation of the substance compound of the therapy module 1 fed. Because the use of the base module 2 or the site of which is preferably located in the clinic, the ephemeral substances can be used for preparation substantially without a time delay shortly before administration of the substance compound to a patient. Exemplary time-unstable substances include radioactive isotopes, such as the beta emitters yttrium, iodine, holmium, fluorine, rhenium, lutetium and alpha emitters and also other chemically or biologically unstable substances that can be used for example for chemotherapy. Half-lives of therapeutically or diagnostically used chemically or biologically unstable or radioactive substances are, according to one embodiment, less than 2 weeks, preferably less than 100 hours, and more preferably less than 50 minutes.

To the base module 2 is with the help of another interface 7 a transfer module 5 connected. So that the base module 2 Protected from contamination by substances, also has the transfer module 5 on the for the connection to the base module 2 provided side a finger-like portion (not shown), which in one of the base module 2 provided and with the interface for the therapy module 2 connected (not shown) opening can be inserted. This will be the transfer module 5 directly with the therapy module 1 connected and it can be exchanged substances between the modules, without any contamination of the base module 2 he follows. Im through the base module 2 Guided section of the transfer module, for example, the quality control of in the transfer module 5 transferred substances or substance compounds take place.

The transfer module 5 serves to accommodate one in the therapy module 1 prepared substance compound and the transport for administration to a patient. Preferably, the transfer module 5 adapted to a particular form of application, such as a syringe, a catheter, a needle and has a corresponding connection interface 10 on. It may further comprise means for metering the correct amount, optionally in dependence on the contained since the filling disintegrated substances. Depending on the application, it may include a shield for toxic and / or radioactive substances to the persons in contact, such as the clinic staff or doctors. The Transfermo dul 5 may further include means (not shown) for identification and assignment to a particular patient, so that the substances contained are released only after unambiguous identification and assurance of compliance with temporal quality parameters. Furthermore it can be an information interface 9 and a corresponding (not shown) data storage for the acquisition of data, such as patient data, identification data, therapy and diagnostic data, product and quality data include.

Also the illustrated transfer module 5 is merely exemplary and may be designed differently. In particular, it is conceivable functions or features of the transfer module 5 in the therapy module 1 provided so that, if necessary, on the transfer module 5 can be waived.

Also more (not shown) to the base module 2 connectable modules can be provided and in the manner described above with the therapy module 1 or the transfer module 5 be configured connectable. Alternatively, it is also conceivable, some or all modules directly to the therapy module 1 connectable to perform.

in the Following is the flow of an exemplary therapeutic procedure described with the involvement of the system according to the invention.

First, will by the doctor when examining a patient the necessary diagnosis or Therapy set. The resulting data will be in the IQS information system and possibly via the detour of the information system entered a clinic.

Preferably in the base module 2 In the case of the IQS system, a therapy or diagnostic plan is subsequently created on the basis of an available quantity of a radioactive isotope or a chemically unstable substance with the help of specially trained personnel. In the treatment plan, in addition to the aspects affecting the drug and the patient, such as the amount, time of administration, etc. of the drug, the equipment, laboratory capacity, personal availability and treatment capacities of the clinic are also taken into account. The therapy plan may be adapted and approved by a responsible person, such as the head of a nuclear medicine laboratory or the head of the oncology department.

by virtue of of the treatment plan are preferably automatically orders for a or several necessary therapy modules triggered.

During this Preparation time can change in the patient's state of health during therapy / diagnostic planning considered become.

On the day of treatment, the required amount of a substance of unstable state or, for example, the isotope for that day is automatically made available in the active agent module and booked for the individual treatments. For this purpose, the active agent module to the IQS base module 2 connected.

At the scheduled time of treatment will be the therapy module 1 in the base module 2 The corresponding patient data is retrieved and becomes the corresponding transfer module 5 , such as a syringe applicator, connected. With the help of the base module 2 In the IQS system, the connected modules are identified, their identity and the stored quality data are checked, the desired amount for the therapy / diagnosis is retrieved, alarm messages are issued in case of errors or the manufacturing process is started. All generated data is stored and the patient data and production data in the base module 2 added.

During the manufacturing process, the required amount of an isotope solution from the active agent module 4 into the therapy module 1 pumped. There, for example, it is labeled with monoclonal antibodies (MABs) that are already in the therapy module 1 are present, mixed. By adding radical binders, such as vitamin C, buffer solutions and similar substances, the process is optimized and correct chemical values are set. In the therapy module 1 it is further ensured that suitable environmental conditions, such as a predetermined pressure and a predetermined temperature, are ensured for an optimal process. With the help of a size exclusion column, also in the therapy module 1 integrated or on the base module 2 may be provided, the substance compound is separated, for example, from unbound isotopes and the quality of the product can be measured by determining the ratio of bound and unbound isotopes via a chromatography step. All collected data is transferred via the IQS base module 2 saved.

Finally, the product or the substance compound in the transfer module 5 transferred. After administration of the substance compounds) becomes the used therapy module 5 possibly through the IQS base module 2 automatically recycled.

The transfer module 5 is from the IQS base module 2 separated and transported to the patient. Administration of the substance compound contained therein can be accomplished by introducing the antibody-bound substance compound into the body, ie, into the bloodstream or into body cavities created by surgery, by injecting into natural joints, or artificially, eg, by surgery, body openings to irritate or destroy tissue of a catheter into a blood vessel for locally influencing tissue, by binding a substance compound to peptides (proteins), sugars or other metabolically implicated substances for imaging or cancer therapy.

On the basis of the elapsed time and of internal measurement data may optionally change, ie the disintegration of the product by means of the transfer module 5 be checked and ensure that a defined expiration is not exceeded by a too long transfer to the patient. Furthermore, with the help of the transfer module 5 a patient, for example, using biometric methods, a card or a bar code, etc. are identified and the amount to be applied in the transfer module 5 be established substance compound. Also, the application itself, which can be done for example by an intravenous injection, can be controlled by the transfer module by means of a blocking device provided on this or a suitable interface. The relevant parameters are the quantity, the applied pressure and the injection rate. Due to the special automatic transfer module 5 The doctor is relieved of a time-consuming slow injection.

Subsequently, the transfer module 5 recycled and possibly sent the isotope module for refilling to a supplier.

Finally, patient data on the success of the treatment as well as, if necessary, the administered radiation dose in the IQS basic module are provided 2 stored or transmitted to a patient file provided at another location, with which processes can be continuously improved or even study data can be collected.

The in the present description, the drawing and in the claims specified features can individually or in any combination for the invention of importance be.

1

therapy module

2

base module

3

admission

4

Active agent module

5

transfer module

6

Control panel

7

interface

8th

network access

9

Information interface

10

Connection interface

Claims (18)

Therapy module for providing a diagnostic or therapeutic substance compound, comprising at least two containers which can be connected to one another for holding at least one substance and means or a part of a means for supplying a quantity of the at least one substance from one of the containers to another container of the therapy module ( 1 ). Therapy module according to claim 1, characterized in that it comprises a plurality of containers, of which at least one container is directly connected to at least two other containers of the therapy module ( 1 ) connected is. Therapy module according to claim 1 or 2, characterized in that at least one of the containers at least one access, in particular for a sensor, and / or a mechanical interface to the outside of the therapy module ( 1 ) having. Therapy module according to one of the preceding claims, characterized characterized in that it one or more at least one container associated pumping means, Dosing and / or sensor means or parts thereof. Therapy module according to one of the preceding claims, characterized characterized in that it a housing in which the containers are included and that the containers By means of cables are connected to each other. Therapy module according to one of the preceding claims, characterized in that it is externally controllable and means for receiving control and / or power supply signals for a means for supplying a quantity of the at least one substance from one of the containers to another container of the therapy module ( 1 ) and / or for a sensor means. Basic module for providing a diagnostic or therapeutic substance compound comprising a receptacle ( 3 ) for a therapy module ( 1 ) according to one of the preceding claims and means for controlling one or more means for feeding a quantity of a substance from one of the containers to another container of the Therapy module ( 1 ) and / or for a sensor means. Basic module according to claim 7, characterized in that it comprises means for detecting at least one parameter from the group comprising the type, amount, temperature, radiation dose, radiation spectrum, residual life, residence time, concentration and the pH value of at least one in the therapy module ( 1 ). Basic module according to claim 7 or 8, characterized that it a data processing unit for process control and a data storage means having. Basic module according to one of claims 7 to 9, characterized in that it comprises means for controlling the supply of a substance into the therapy module ( 1 ) from outside. Basic module according to one of claims 7 to 10, characterized in that it comprises means for controlling one or more accesses or interfaces of the therapy module ( 1 ) having. Basic module according to one of claims 7 to 11, characterized that it at least part of at least one provided in the therapy module Pumping agent, dosing, sensor means and / or evaluation of the sensor means. Basic module according to one of claims 7 to 12, characterized that it can be coupled with a computer or computer network. System comprising a therapy module ( 1 ) according to one of claims 1 to 6 and a base module ( 3 ) according to one of claims 7 to 13. System according to claim 14, characterized in that it comprises an active agent module ( 4 ) for storing and / or producing short-lived, in particular chemically and / or biologically unstable substances and / or radioactive isotopes. System according to claim 14 or 15, characterized in that it comprises a transfer module ( 5 ) for storing and transporting one or more substances or substance compounds, wherein the transfer module ( 5 ) Means for metering an amount of the substance or substance compound in dependence on the already decomposed substance portions of a substance or substance compound. System according to one of claims 14 to 16, characterized in that the therapy module ( 1 ), Active agent module ( 4 ), the basic module ( 2 ) and / or the transfer module ( 5 ) are interconnected by means of interfaces and that there are means for transporting substances from the active agent module ( 4 ) into the therapy module ( 1 ) and / or the therapy module ( 1 ) into the transfer module ( 5 ). System according to one of claims 14 to 17, characterized in that the therapy module ( 1 ), Active agent module ( 4 ), the basic module ( 2 ) and / or the transfer module ( 5 ) have a shield against radioactive radiation and / or a structure preventing the escape of substances.