WO2013087573A2

WO2013087573A2 - Device for analysing patient samples

Info

Publication number: WO2013087573A2
Application number: PCT/EP2012/074962
Authority: WO
Inventors: Michael Borchardt; Andreas Scheipers; Rainer Feldbruegge; Martin Brinkmann
Original assignee: sense2care GmbH
Priority date: 2011-12-12
Filing date: 2012-12-10
Publication date: 2013-06-20
Also published as: WO2013087573A3; DE102011056271A1

Abstract

A device (10) for analysing patient samples is provided, having a patient module (21) which can be used only for one patient (12), said module being equipped to receive at least one patient sample and incorporating sensors (37) to take measurements of the patient sample as well as at least one storage chamber (27) containing a sensor solution (27a). In addition, a reusable measurement module (23) is provided which can be mechanically connected to the patient module (21) in a detachable manner and which picks up and processes measurements from the sensors (37), and supplies a determination of physiological patient parameters. The patient module (21) and the measurement module (23) are designed such that they remain mechanically connected to each other during the receiving and analysis of at least two patient samples taken in temporal succession.

Description

Device for analyzing patient samples

The present invention relates to a device for analyzing patient samples, with a usable only for a patient patient module, which is equipped to hold at least one patient sample and sensors for detecting measured values of the patient sample and at least one pantry containing a sensor solution, and with a reusable measurement module, which is mechanically detachably connectable to the patient module and the measured values of the sensors decreases, processes and supplies a determination of physiological patient parameters.

Such a device is known from WO 97/21381 AI. The known and other devices of the prior art serve to bring in the field of clinical chemistry and laboratory medicine, the diagnosis closer to the patient (the so-called. "Point of care"), ie to the bedside. In this context, the so-called "bedside monitoring", ie the determination of important parameters directly next to the patient becomes more and more important. These important parameters include in particular physiological blood parameters, which are determined by measurements on blood samples.

The previously known blood analysis, taken in the blood samples venous or arterial and then stored in special containers and spent or sent to a corresponding analyzer, has indeed proven in many applications, however, often require a general practitioner and rapid information about the physiological blood parameters of a patient in order to be able to intervene promptly in the event of serious danger.

However, especially in the treatment of acutely and severely ill patients, it is important for the treating physicians to quickly and easily obtain precise information about the physiological blood parameters of the patient. These blood parameters include u.a. the blood gases (pÜ2, pCÜ2, pH), the electrolytes (Na, K, Ca, Cl), the conductivity of the blood and the hematocrit and the metabolites (glucose, lactate, urea, creatinine) as well as derived or calculated further blood parameters.

The present invention is concerned with the improvement of generic devices that are used in particular in the operating room and the intensive care unit. They are intended in particular for patients who already have an arterial or venous access or in whom there is an extracorporeal blood circulation or tube systems which serve for wound drainage, that is to say the removal of wound water. For this purpose, stand-alone devices are known in the art, which have an open fluid interface for introducing the sample to be analyzed. The transfer of the sample to this stand-alone device takes place by means of a sample volume container, eg a syringe, glass capillary or a pipette. The sample volume is taken from the patient or tubing sampling point and transported in this container.

Although the transport can be short, is associated with this method and this arrangement, the inherent disadvantage that can occur in particular in larger hospitals confusion of samples, with the sample on the transport, for example. By temperature changes, outgassing, intrusion of Can change oxygen or even in their chemistry.

Another disadvantage of the known systems is that they either do not allow a close-meshed extraction of measured values, and / or that the accuracy of the devices, in particular the sensors used, is not sufficient to guarantee a sufficient significance of the obtained physiological blood parameters ,

Another problem many sensor systems is also the lack of ability to calibrate the sensors before or between the measurements can.

The known from the aforementioned WO 97/21381 AI device comprises a patient module in the form of a measuring cartridge and a measuring module in the form of a hand-held measuring device, wherein the measuring cartridge before and / or after taking a blood sample for the purpose of calibration of sensors and the Measured data acquisition and processing is brought into physical contact with the hand-held device. The measuring cartridge is provided with a connection for a sampling device and a further connection for a pumping device. Storage chambers are provided between these two connections, in which calibration and / or conditioning solutions for sensors are arranged. In the area of another chamber, the sensor chamber, sensors are provided, which take readings from the recorded blood sample. The measuring cartridge also contains a collecting chamber in which the recorded blood sample and the calibration solutions used are collected after use.

The measurement cartridge is further provided with channels and fluidic controls which provide the ability to move the blood sample and / or the calibration fluids within the fluid channels and chambers by depressurizing or overpressuring the measurement cartridge via the pumping device external to the measurement cartridge be generated.

The measuring cartridge is provided, for example, with a hypodermic needle at one end and a syringe at its other connection, so that when the syringe is pulled up, a blood sample is taken directly from the patient or from the patient with the aid of the needle connected tubing system is partially pulled through the measuring cartridge into the syringe. In this way, a part of the blood sample remains in a sample chamber in the measuring cartridge.

The measuring cartridge is then removed from the patient and inserted into the hand-held device.

About the hand-held gauge mechanical pressure is applied to the cartridge to actuate the fluidic controls. Furthermore, electrical signals can be transmitted between the hand-held measuring device and the measuring cartridge. In this way, by appropriately moving the syringe plunger and simultaneously switching the fluidic control elements, it is possible to first calibrate the sensors contained in the measuring module by means of the calibration solutions and then to guide the sample to the sensors in order to take the measured values. which are then transferred from the measuring cartridge to the hand-held measuring device. There then takes place the evaluation and possibly display or storage of the specific blood parameters.

The calibration can take place before or after the sampling.

The measuring cartridge consists in one embodiment of two cartridge halves, between which in a cavity, the sensor chamber is formed. These chambers have a fixed volume.

In a cartridge half, which serves as a fluid reservoir, there are chambers for receiving the calibration solution, for temporary storage of the blood sample and for the collection of spent fluids.

The sensors are arranged on a foil which can be arranged on one or both cartridge halves.

The measuring cartridges are designed as disposable cartridges, so that they are discarded after the single removal of the sample on a patient and the evaluation of the sample.

A number of disadvantages are associated with the known device.

On the one hand, it is not suitable for a quasi-continuous, close monitoring of one of the blood parameters of a patient, because the handling of and the amount of consumables in the clinic everyday life, especially in the intensive care unit and in the operating room are not accepted.

On the other hand, the known device allows only a conditional near-patient use, because for example in the operating room, the hand-held device will be outside the surgical area, so that must be intervened with the measuring cartridge in the operating area to take blood there, or the measuring cartridge is with connected to a leading out of the surgical area hose system.

While the introduction of the measuring cartridge into the operating area meets the greatest hygienic concerns, there are inherently other disadvantages associated with connecting the measuring cartridge to a tube system outside the operating area. On the one hand, the blood must be led far out of the surgical area via the tube system, so that changes in the blood parameters can already be made in this way.

On the other hand, not only does the blood cool down in this way through the tube system, the measuring cartridge itself is not at body temperature, but is exposed to the changing ambient temperatures outside the operating range. This also leads to the fact that the measured values can only have limited significance, because as is known, the values of the blood parameters also change with changing ambient temperature.

It has also been found that the displacement of liquid volumes within the measuring cartridge by means of the syringe not only brings problems in handling with it. Through the piston volume of the syringe, in these manipulations, the calibration solutions come into contact with ambient air, so that they can outgas or react with constituents of the ambient air. For all these reasons, the known device has proved to be unsuitable.

From EP 1 495 808 AI a disposable cassette is known as a replaceable part of a stand-alone analyzer for liquid patient samples.

This disposable cassette is provided with a sample input and contains within a rigid housing designed as a bag container with Kalibrierflüssigkeit and designed as a waste container bag.

In addition to the bags, a channel structure is formed in which liquids are transported via actuators in the form of valves and pumps.

With the analyzer gases or electrolytes in whole blood, serum or urine can be measured, with all liquids, so the sample to be analyzed and the required calibration remain in this disposable cassette.

Although not mentioned in detail in this document, sensors also appear to be present in the disposable cassette, which are recalibrated before and after the measurements with the aid of the calibration fluids.

The cassette can be reused until the supply of calibration liquid is used up. Since the cassette has only one fluid access, namely the port for receiving the blood sample, but no outlet for liquids, the disposable cassette fills in the course of use with the blood samples, which can then be disposed of hygienically together with the disposable cassette.

The known from EP 1 495 808 AI device thus has exactly the disadvantages that have been described above in connection with the device known from WO 97/21381 AI. The measuring cartridge must either be repeatedly intervened in the surgical field, or the blood sample is removed via a tube system far outside the surgical area.

Another problem associated with it is that the analyzer is a stand-alone device to which the measuring cassette must then be spent each. On the one hand, the danger of confusion with the other is associated with the danger of temperature change. Also, a chemical / physical change of the blood sample may occur during the time elapsed between the sampling and the data acquisition.

Furthermore, a close monitoring of blood parameters of a patient is possible only with great effort and only for small periods because of the complex handling and the significantly higher blood requirements.

Also, from EP 1 456 635 Bl a disposable cassette is known as a replaceable part of a stand-alone analyzer for liquid patient samples.

The known disposable cassette contains sensors and rigid containers with calibration solutions and a rigid collection container for spent solutions. Also provided is a peristaltic pump which pumps fluids within the disposable cassette and assists in receiving blood samples that are automatically or manually input via a syringe into an access line.

The same disadvantages are associated with this disposable cassette as with the device known from EP 1 495 808 A1.

EP 0 958 498 B1 describes a sensor device for measuring blood parameters, which is located between an infusion pump and a venous catheter is arranged in series with the infusion tube and lies on the arm of the patient.

The infusion pump pumps infusion solution through the sensor device into the patient and at certain times reverses the direction of flow, so that first infusion solution, then diluted blood and finally whole blood flows backwards through the sensor device, which is then measured.

After the measurement, the pumping direction is reversed again, and whole blood, diluted blood and finally infusion solution is returned to the patient.

The sensor device is connected via a cable to an analyzer, which further processes the measured values. There is also a system control connected by cable to and controlling the infusion pump and the analyzer.

In this device is mainly of disadvantage that the infusion solution flows permanently through the sensor device and the sensors can not be calibrated between measurements. Therefore, this device can only be used for limited applications, wherein the accuracy of the measured values determined for many applications is also insufficient.

EP 1 533 614 A1 describes a sensor card which is equipped with various sensors with which analytes in liquid or gas samples can be determined.

The known sensor card has a sensor film and a cover film, wherein the sensor film comes into contact with the liquid sample to be analyzed in a measurement. Between the cover sheet and the sensor film, an intermediate film is arranged. The sensor film is provided on its side facing the intermediate film with electrical conductor tracks.

The cover foil serves to provide measured values, which are tapped off by the sensors, on the side facing away from the blood sample for a measuring device.

Sensor cards, as described in this document, can also be used in the context of the present invention, so that the disclosure of this document is made by reference to the subject of the present application.

US Pat. No. 7,198,606 B2 describes a device with which, with the aid of a lancet, blood samples can be taken automatically from a finger and fed to an automatic analysis. The device comprises a plurality of lancets which can be automatically advanced in succession, the blood samples thus taken being placed in a central cassette where they are analyzed separately.

Each lancet is assigned a separate analysis sensor, each of which is designed to determine the blood glucose level.

Although with this device, the blood glucose level of a patient at certain intervals, so can be monitored virtually continuously, it is yet for use in a sterile or almost sterile area, as found in the operating room or in the intensive care unit, already due The blood collection over an open wounded with the lancet in the finger open wound is not suitable. Ahn et al .: Disposable Smart Lab on a Chip for Point-of-Care Clinical Diagnostics, Proceedings of the IEEE, Jan. 2004, Vol. 1, pp. 154-173, like WO 97/21381 A1 mentioned at the beginning, describes a patient module which can be inserted into a reusable measuring module and which is designed as a disposable part and is intended and designed only for the analysis of a single patient sample. The known device thus has the same disadvantages as discussed above in connection with the device known from WO 97/21381 AI.

The news TEC newsletter of the top cluster MicroTEC Südwest, issue 2/2011, Freiburg, November 2011, page 3 above, describes a planned system for the analysis of blood gases and electrolytes, with the course of treatments should be closely monitored. For this purpose, electrochemical sensors are to be integrated into a BGA module, which is designed as a disposable component. The proposed system is not intended to require its own vascular access, but rather is connected via a T-piece to an invasive monitoring system that is standard in the clinic.

US 2005/0130292 A1 describes a system for point-of-care analyzes, which comprises an analyzer into which a biochip is inserted, after it has taken up blood via its micro needle pierced into the patient. The Biochip is a self-sufficient, energy-efficient disposable item equipped with sensors, valves, calibration fluids, microfluidic channels and its own power source, as well as connections to the analyzer.

These systems also have the disadvantages described above in connection with WO 97/21381 AI.

Against this background, the present invention seeks to provide a device of the type mentioned, with a quasi-continuous monitoring of physiological patient parameters is possible, it should be possible to arrange the new device close to the patient, so that the above-mentioned disadvantages of the prior art are avoided.

According to the invention this object is achieved in the known device, characterized in that the patient module and the measuring module are adapted to remain mechanically connected to each other during the recording and analysis of at least two consecutively taken patient samples.

The problem underlying the invention is completely solved in this way.

Since the patient module and the measuring module remain mechanically connected one after the other during the duration of the recordings and the analyzes of a plurality of patient samples, the device can be arranged in the patient area and is suitable for the quasi-continuous long-term analysis of patient samples, in particular blood samples, taken at a time interval.

The processing according to the invention of the measured values in the measuring module fastened mechanically to the patient module means that the measured values taken by the sensors are processed directly on site, ie in the immediate vicinity of the sensors. Since the sensors are often very high-impedance, this processing "on site" contributes to the desired high measuring accuracy.

Namely, the analog measuring signals need not be transmitted to the analyzer via a cable, as is the case for example in the case of the device known from EP 0 958 498 B1, but are at least preprocessed in the measuring module. In the simplest case, this means that the analog measurement signals are digitized so that they can be passed on largely without interference. Because the new device is located close to the patient, on the one hand the risk of confusion is eliminated. Furthermore, there is neither a risk of contamination during the transport of the patient sample nor the risk that the temperature of the patient sample changes, because the new device is namely arranged in the patient area, possibly even on the patient himself.

The invention thus provides for the first time a patient-near device for the detection of physiological patient parameters, so as to eliminate the transport routes and the risk of confusion of patient samples, the possible contamination of the patient samples taken and the entry of impurities in the patient area.

For the purposes of the present invention, a "patient sample" is understood as meaning a physiological sample, primarily a blood sample, which is used to determine physiological blood parameters Other endogenous samples, such as urine, lymph, wound water, collectively also referred to as physiological samples however, can also be detected with the device of the invention A patient sample is thus a liquid which is passed into or out of the patient's body or in a rinsing, dialyzing or filtering system in contact with body fluid.

In the context of the present invention, a "patient area" is understood to mean the spatial area in which the patient is stored and in which hygiene plays an important role. This may be the operating area in an operating room or the care and monitoring area in an intensive care unit. The patient area may thus be the area immediately around the patient's bed, couch or stretcher or around an operating table. In particular, this patient area can be a sterile or at least almost germ-free or disinfected area. In the context of the present invention, the arrangement of the device in the patient area, ie either on the patient himself or directly next to the patient, for example on the patient's lying surface, is understood by "patient-near arrangement". Such devices are therefore often in the sterile field, for example. Under the cover of the patient.

In the context of the present invention, "quasi-continuous long-term analysis of patient samples taken at a time interval" is understood as meaning a measuring method in which samples of the patient are picked up by the new device at fixed or selectable time intervals, for which measurements are taken in each case. from which then physiological parameters are calculated, which are also referred to here as patient parameters. This long-term analysis, for example, takes place during the duration of an operation at intervals of a few minutes and during the care and monitoring in an intensive care unit, depending on the condition of the patient at intervals of many minutes to hours.

In the context of the present invention, an ability of a measuring module to be able to process measured values and determine physiological patient parameters means that the measuring module processes the measuring signals, in particular as analog signals, for example digitized, and then either forwards an external computer unit, which determines the physiological parameters therefrom, or even carries out this further calculation on-site, so to speak.

In the context of the present invention, a sensor solution contained in a storage chamber is understood to mean an auxiliary medium which is used before and / or after the measurements for carrying out reference measurements, calibrating, conditioning, rinsing, or otherwise the sensors prepare for the next measurement to ensure consistently high measurement accuracy during long-term analysis. The at least one pre- The chamber is filled with the relevant sensor solutions before delivery of the patient module.

In the context of the present invention, a "patient module which can be used only for a patient" is understood to be the part of the device which remains on the patient during the long-term analysis, but is subsequently disposed of and can not be reused. When the sensor solutions are exhausted, it may be necessary to change the patient module during the long-term analysis.

With the new device for the first time a close monitoring of patient parameters, in particular of physiological blood parameters in a long-term analysis with the required precision is possible without the patient or the staff are excessively burdened. In addition, with the new system even the mobility of the patient with continuous close-meshed monitoring is possible, as it may be required, for example, in a transfer of the patient. Close monitoring is possible in this case in particular because the new device only requires small patient sample quantities, which can be achieved inter alia. based on the patient-near arrangement.

The new device may either be connected directly to the patient via a venous or arterial catheter, or connected to a tubing system to which the patient is attached. This tube system may for example be part of an extracorporeal blood circulation or a wound drainage system, but it may also serve invasive pressure measurement, as described, for example, in M. Brinkmann (2006), Invasive Blood Pressure Monitoring, White Paper, Smiths Medical, and M. Brinkmann (2005), Invasive Blood Pressure Monitoring - Theory and Practice, White Paper, Smiths Medical.

The new device can either be connected directly to the sampling point, or via a three-way valve. In this case, a syringe that is still to be manually operated, for example, is withdrawn from the tubing system via a pumping system until whole blood reaches the removal point at which the new device is connected to the tubing system.

Because the new device is placed close to the patient, the distance between the donor site and the patient can be very small and even within the patient area.

This then means that only a small amount of liquid and subsequently diluted blood must be taken from the tube system until whole blood emerges at the sampling point.

The entire control, in particular taking place at the donor site in the patient area removal of the blood, can be done outside the patient area manually or automatically.

It may be provided that the new device first checks whether usable blood, that is, whole blood, is present at the removal site before the blood sample is taken up and processed in the new device.

Especially in systems for invasive pressure measurement, which are designed as closed systems, the withdrawn diluted blood can be subsequently infused back into the patient via the tube system, so that the volume of the blood sample taken in the new device is conceivably low.

In this case, it is preferred if the measuring module can be connected via at least one connection that can be brought out of the patient area to a computer unit for displaying and / or storing the specific patient parameters. Here it is advantageous that the computer unit can do all the tasks that should not be realized directly in the measurement module due to space limitations or because of heat. The computer unit, however, always serves to store the physiological parameters and permanently display them to the clinical staff. The connection can be so long that the computer unit can be arranged outside the critical patient area.

The new device is therefore very compact, so that it can be easily accommodated in the patient area.

The connection is preferably a multiple line having pressure lines for controlling an actuator in the patient module and electrical lines for transmitting control signals to the measurement module and measurements from the measurement module.

The connection between the measuring module and the computer unit transmits only interference-prone signals, because the measured values taken by the patient samples are processed before transmission, preferably at least digitized.

The actuator system in the patient module in this case comprises channels for guiding fluids, valves and at least one pump, so that fluids can be moved within the patient module.

Further, it is preferred if within the patient module at least one pump is provided, which is switchable via at least one valve with a sample access in fluid communication.

Here it is advantageous that the patient samples are actively sucked into the patient module, so that no external pumps are required. This will cause contamination with ambient air and transport of eg blood in two directions through the patient module avoided. An external access line leading to a sampling site for blood samples may be connected to the sample access.

Furthermore, it is preferred if the patient module can be connected to only one access line, via which patient samples enter the patient module.

From a hygienic point of view, it is advantageous here that measured patient samples and sensor solutions used can not escape from the patient module.

In general, it is preferred if the patient module comprises a carrier and a diagnostic unit carried thereby, wherein the carrier contains the at least one storage chamber, and the diagnostic unit contains the sensors.

This has the advantage that the individual modules of the patient module, which can be used only for one patient, can be manufactured and tested separately before they are joined together. This facilitates quality control and assembly.

Further, it is preferred if the carrier contains a collection chamber for spent sensor solutions and patient samples analyzed, wherein preferably the diagnostic unit includes a fluidic card in which a measuring channel, at least one connected to the measuring channel pump, valves, a connection to the at least one storage chamber and a sample access are provided via which the patient samples enter the patient module, and wherein preferably the diagnostic unit includes a sensor card, on one side of the sensors and on the other side an interface for connection to the measuring module are provided. These measures are structurally advantageous because the patient module is modular, so that the individual modules can be manufactured separately and tested before they are joined together. This facilitates quality control and assembly.

In this case, it is also preferred if the connection to the storage chamber comprises a piercing tip which, when the fluidic card or the measuring module is placed, punctures a cover foil which closes off the storage chamber.

This measure is not only constructive advantage, it also serves the quality assurance, because the sensor solutions are gas-tight in the pantry completed until either the final assembly of the new device, the fluidic card is placed on the support and suitably secured , or even when later use the measuring module is snapped.

The patient module is a disposable article while the measurement module is reusable. The computer unit can also be designed to control various measurement modules.

Against this background, the present invention also relates to a patient module for the new device comprising a support comprising at least a storage chamber for sensor solution, and a diagnostic unit attached to the carrier, which contains sensors, and to which a measuring module is plugged ,

Furthermore, the present invention also relates to a measuring module for the new patient module, with a multiple line for connection to a computer unit, and with an interface for connection to the diagnostic unit, and a computer unit for the new measuring module, with a control module for controlling the measuring module and the diagnostic unit. Furthermore, the present invention also relates to a fluidic card for the new patient module, in which at least one pump is provided, which is switchable via at least one valve with a sample access in fluid communication.

Finally, the present invention also relates to a system with the new patient module, the new measurement module and the new computer unit.

Fluidic card, carrier, measuring module, patient module and computer unit are independent assets that can be manufactured and sold separately from the other modules, but still develop their full functionality only in cooperation with the other modules.

Further advantages will become apparent from the description of the accompanying drawings.

It is understood that the features mentioned above and those yet to be explained not only in the combination given, but also in other combinations or alone, without departing from the scope of the present invention.

Embodiments of the invention are illustrated in the drawings and are explained in more detail in the following description. Show it:

1 shows a schematic structure of the new device in conjunction with external control module and display module and a schematically indicated sampling point.

Fig. 2 is a block diagram of the individual modules of the apparatus of Fig. 1;

Fig. 3 is a plan view of the fluidic card of the apparatus of Fig. 1; FIG. 4 is a plan view like FIG. 3, but showing the sensors and sensor contacts; FIG.

Fig. 5 is a bottom view of the sensor card of the apparatus of Fig. 1;

6 is a plan view of the patient module of the device of FIG.

1; and

7 is an enlarged sectional view of the patient module of FIG. 6, seen along the line VII - VII of FIG .. 6

In Fig. 1 is denoted by 10 a device for quasi-continuous long-term analysis of spaced-apart patient samples, which is connected via an access line 11 with a sample-carrying system 12.

The sample-carrying system 12 may either be the patient himself or a tube system connected to the patient. In the present exemplary embodiment, blood samples are conducted via the access line 11 into the device 10, which generates measured values for these blood samples, from which physiological blood parameters are determined.

The new device 10 is connected via a connection in the form of a multiple line 13 to a computer unit 14, which serves the display and storage of determined by means of the device 10 physiological blood parameters.

The computer unit 14 comprises a control module 15 and a display module 16 connected thereto and is provided outside a patient area 17, which is separated in FIG. 1 by a dashed line 18 from the environment 19 remote from the patient. The computer unit 14 can be arranged outside the patient area 17 with a corresponding length of the multiple line 13. This is particularly possible because only those signals are routed through the multiple line 13, which are not subject to interference even with longer transmission paths, as they can be caused by electromagnetic fields that leave other equipment in the operating room or in the intensive care unit.

The computer unit 14 also serves, in a manner to be described, to control the device 10 in such a way that it carries out calibration steps which feeds blood samples to a detection of measured values and to determine the physiological blood parameters from the measured values supplied by the device 10 , At least some of these additional tasks can also be shifted into the device 10 with a corresponding degree of integration of the individual modules of the device 10.

In still to be described way, the multiple line 13 includes pressure lines and electrical leads and electrical leads.

The connection may also contain radio links in addition to the multiple line 13.

In the patient area 17 are thus the patient and partially the possibly provided hose system and the new device 10th

The device 10 is thus arranged close to the patient, the length of the access line 11 can be as short as desired, so that the device 10 can be placed on the patient or directly next to the patient under a blanket. The device 10 has a modular structure and comprises a patient module 21, which is connected via the access line 11 to the sample-carrying system 12.

Furthermore, the patient module 21 is connected via an interface 22 to a measuring module 23 which is detachably latched to the patient module 21 and to which the multiple line 13 is connected. The interface 22 serves to transmit electrical and pneumatic signals.

The patient module 21 is configured such that it can remain with the ridden measurement module 23 for quasi-continuous long-term measurements on the patient. After the end of the use, however, the patient module 21 is discarded, since the measured blood samples accumulate in the patient module 21 in a manner to be described later.

On the other hand, the measuring module 23 is designed so that it does not come into contact with the blood sample, so that it can be reused.

The measuring module 23 provides for the interface 22 electrical contacts 24 and pneumatic / mechanical contacts 25 to the patient module 21, so that control signals can be introduced into the patient module 21 and measurement signals can be queried from the patient module 21.

In particular, the actuators are controlled via the pneumatic / mechanical contacts 25, which causes the transport of fluid volumes within the patient module 21.

The patient module 21 comprises a carrier 26 designed as a fluid reservoir, in which storage chambers 27 for schematically indicated sensor solutions 27a and at least one collection chamber 28 for spent sensor solutions 27a and measured blood samples are provided. The sensor solutions serve to prepare the sensors by calibration and / or conditioning and / or rinsing for the next measurement, or to perform reference measurements. These measures ensure a consistently high measuring accuracy during the long-term analysis.

The storage chambers 27 are separated via walls 29 from the collection chamber 28. These walls 29 are stretchable, elastic or at least so flexible, yielding or movable that the volume of the storage chambers 27 gradually decreases in consumption of the sensor solutions 27a contained therein, while the volume of the collection chamber 28 introduced by spent sensor solution 27a and measured whole blood gradually enlarged. The volumes of storage chambers 27 and collection chamber 28 are therefore variable.

In this way, the total volume of the fluid reservoir in the carrier 26 changes only slightly during the course of the measurements, namely by the gradual addition of measured blood samples and possibly additionally occupied volumes of rinsing solution, flushed with the sampling point between the samples becomes.

Since each measured blood sample corresponds to a volume of, for example, 0.1 ml, even with a 24-hour quasi-continuous monitoring with 10-minute sampling no more than 14.4 ml of additional blood volume accumulates, which is additionally stored in the fluid reservoir in the carrier 26 must be stored.

This small volume can easily be taken up by the collection chamber 28 together with the volume of spent sensor solution 27a.

The carrier 26 may have any shape, in the embodiment shown, however, it is in the form of a sleeve, which according to Art a blood pressure cuff can be placed around the upper arm of a patient.

In this carrier 26, in which the storage chambers 27 and the collection chamber 28 are provided, a diagnostic unit 30 is suitably attached, in which the other components of the patient module 21 are arranged, then the measuring module 23 is clicked.

Above the carrier 26, the diagnostic unit 30 has a fluidic card 31 which is connected via plungers 32 with the storage chambers 27 and via a permanently open access port 33 with the collection chamber 28.

Valves and pumps are provided in the fluidic card 31 in a manner to be described in order to displace the liquids to be used in the device 10 within the patient module 21.

Above the fluidic card 31, a sensor card 35 is disposed in the diagnostic unit 30, 36 sensors 37 are provided on the underside, which cooperate in a manner to be described with a measuring channel in the fluidic card 31, where it with the Contact the blood sample and the calibration solutions.

On its upper side 38 remote from the underside 36, the sensor card 35 is equipped with sensor contacts 39, which are electrically connected to the sensors and provide the measuring signals of the sensors 37 at the interface 22 for the electrical contacts 24.

The patient module 21 described so far thus has as a single liquid input to the access line 11, are recorded on the patient samples. Furthermore, the patient module 21 has at the top 38 of the sensor card 35, the sensor contacts 39, are provided via the measured values of the sensors 37 for the measuring module 23.

Not shown in Fig. 1 is the connection 22 also taking place via the interface of the pneumatic / mechanical contacts 25 to the lying under the sensor card 35 fluidic card 31, and the supply of the sensor card 35 with electrical energy.

The measuring signals recorded by the measuring module 23 are then directed to the control module 15, which is already located outside the patient area 17.

In the control module 15, the physiological blood parameters are then determined from the measured values of the sensors 37, which can then be displayed on the display module 16 and otherwise stored as usual.

[00140] How the physiological blood parameters can be calculated from the measured values of the sensors 37 is well known to the person skilled in the art. For this purpose, reference may be made, for example, to the state of the art extensively cited in the introduction to the description, the disclosure of which is hereby made the subject of the present application.

The interaction of the individual components of the patient module 21 with those of the control module 15 and the display module 16 is shown in detail in the block diagram of Fig. 2.

In Fig. 2 it can be seen that the display module 16 as a central unit includes a computer 41 which cooperates with a touch screen 42 and a printer 43. Furthermore, a bar code scanner 44 can be provided, into which the ID code of the respective patient module 21 is read. Fertilize over LAN Verbin 45, the display module 16 on the one hand to the control module 15 and on the other hand connected to external networks 46.

The control module 15 includes in a conventional manner a power supply 47 and a control interface 48 which cooperates with an electronic control unit 49. Via electrical lines 50, the interface 48 is connected to the multiple line 13.

The control electronics 49 controls an actuator unit 51 which generates control signals which act on a pneumatic unit 52 and from there via the multiple line 13 in a manner to be described on valves and pumps in the patient module 21.

Further, in the control module 15, a temperature controller 53 is provided, which cooperates with a heater 54 in the measuring module 23 in order to temper the patient module 21.

Via the multiple line 13 pneumatic control signals are passed via pressure lines 55 from the pneumatic 52 to Aktorikelementen 56 in the patient module 21. These Aktorikelemente 56 act on a fluidics 57, which are provided together with the Aktorikelementen 56 in the fluidic card 31 of FIG.

Above the fluidics 57, the sensor card 35 is arranged, which communicates via the electric contacts 24 and the sensor contacts 39 formed electrical contact pairs 58 with the measuring module 23 via the electrical lines 50, the control signals to the measuring module 23 and conduct measurements of the Transmit measuring module 23 to the control module 15.

The transfer of the signals of the pressure line 55 follows via a schematically indicated at 59 pneumatic contact pair. The pneumatic contact pair 59 transmits either compressed air or mechanical control signals which act on the arranged under the respective contact pair 59 Aktorikelemente 56. For example, these actuators include valves and pumps.

In the measuring module 23, an RFID reader 61 is further provided which cooperates with an RFID chip 62 provided in the patient module. In this way it can be verified that the ID code of the patient module 21, which was read into the computer 41 via the bar code scanner 44, actually corresponds to the RFID of the currently used patient module 21.

In other words, the measuring module 23 detects the ID code of the patient module 21 via its RFID reader 61 and compares it with the ID code stored in the computer 41. In this way, confusion can be avoided in advance.

In the measuring module 23, a microcontroller 63 is still provided, which communicates via the electrical lines 50 with the control module 15 and a measuring electronics 64 controls and queries.

The measuring electronics 64 supplies electrochemical sensor signals, pressure signals, temperature signals, signals about the quality of the sample (whole blood or not) etc. to the microcontroller 63.

The sample to be measured passes via the access line 11 into the fluidic system 57, the access line 11 here being connected to a patient line 65 of an invasive pressure measuring system 66, which is in fluid communication with the patient 12.

Such invasive pressure measuring systems 66 are well known in the art; see M. Brinkmann (2006) and M. Brinkmann (2005) loc. cit. The access line 11 via a merely schematically indicated three-way valve 67 to be connected to the invasive pressure measuring system 66 such that at certain measuring times first liquid and diluted blood, then whole blood from the patient line 65 is sucked into the pressure measuring system 66. Then, when whole blood reaches a sampling point indicated at 68, the supply line 11 is opened, so that whole blood flows directly into the fluidics 57.

Once the appropriate amount of sample has been taken, the supply line 11 is again switched off from the patient line 65, so that in the invasive pressure measuring system 66 sucked patient blood can be returned to the patient.

Because the device 10 is permanently positioned close to the patient, the transport routes for the blood sample are eliminated and the paths the blood sample has to travel in the tube system until it can be measured are short. The volumes of the blood samples are therefore very low, it is already 0.1 ml to be able to determine different blood parameters.

FIG. 3 shows a plan view of the upper side 69 of the fluidic card 31 from FIG. 1.

In the upper side 69 of the fluidic card 31, initially an upwardly open measuring channel 71 can be seen, which has an inlet 72 and a drain 73. The inlet 72 is connected via a provided in the fluidic card 31 and therefore shown in phantom channel 74 with the access line 11. Via a likewise present in the fluidic card 31 and shown in broken lines channel 75 of the inlet 72 is connected to valves 76 which lead to the measures provided for on the underside of the fluidic 31 Einstechspitzen 32, which - as shown in Fig. 1 - with the storage chambers 27 are in communication. The drain 73 is connected via a likewise in the Flui dik- card 31 extending channel 77 with a pump 78 which is connected via a further channel 79 with the access port 33 to the collection chamber 28.

The access line 11 is connected to the channel 74 via a sample access 80, for example a Luer-Lock. Between sample access 80 and channel 74, a valve 81 is likewise provided which can be designed as a check valve and / or as a "normally closed" valve, so that neither sensor solution nor blood once more entered into the fluid card 31 can escape from the patient module 21.

The valves 76 and 81 are not electrical valves, but they are actuated by mechanical pressure valves, which are controlled via the pneumatic / mechanical contacts 25, so the contact pairs 59. The drive signals are routed via the pressure lines 55.

Also, the pump 78 is an actuated by mechanical pressure pump and is driven via the pressure lines 55.

Depending on the position of the valves 81, 76, the pump 78 can be connected in fluid communication with one of the storage chambers 27, the collection chamber 28 and the access line 11 and so sensor solution 27a from the storage chambers 27 or whole blood from the access line 11 in the Suction in measuring channel 71. After the calibration / measurement has taken place, the liquid is led out of the measuring channel 71 via the channels 77 and 79 into the inlet connection 33 and from there into the collection chamber 28.

In this way, liquid can be selectively transported into and out of the measuring channel 71 via the pump 78. The upper side 69 of the fluidic card 31 is gas-tight and liquid-tightly connected to the underside 36 of the sensor card 35, so that liquids present in the measuring channel 71 can neither outgas nor react with constituents of the ambient air.

In Fig. 4, the arrangement of the sensors 37 and the sensor contacts 39 and cut the carrier 26 with the storage chambers 27 is shown in a representation as in Fig. 3 in addition.

It can be seen in FIG. 4 that the sensors 37 are arranged so that they lie over the measuring channel 71 which is open at the top, so that they come into direct contact with the liquid in the measuring channel 71.

The piercing tips 32 are above the storage chambers 27th

In this way, the sensors 37 can first be rinsed and / or calibrated from the storage chambers 27 via sensor solutions 27a before they then come into contact with whole blood and take the corresponding measured values, which are then directed to the measuring module 23 via the sensor contacts 39 become.

In Fig. 5, only the sake of completeness nor the sensor card 35 is shown from its bottom 36 ago.

Again, it can be seen that the centrally arranged in a row sensors 37 are surrounded on both sides of sensor contacts 39, with which the sensors 37 are queried.

Figures 6 and 7 show a plan view and a sectional view of the not yet assembled patient module 21, after the assembly and before or during use nor the measuring module 23 is clicked. It can be seen that both the storage chambers 27 and the collecting chamber 28 are formed in a cross-section of FIG. 7 flat, elongated sleeve 82, on the transverse to the longitudinal direction L, the diagnostic unit 30, so the sensor card 35 and Fluidic card 31 are secured in a suitable manner. In Fig. 6, the fluidic card 31 below the schematically indicated sensor card 35 can not be seen.

On the sensor card 35, the contacts 39 and schematically two latching bridges 83 can be seen, which can also be seen in Fig. 7. The latching bridges 83 serve for latching the measuring module 23 to which corresponding counterparts are arranged.

The cuff 82 has a flexible outer skin 84 which encloses the storage chambers 27 and collection chamber 28, with respect to which the storage chambers 27 are defined by the flexible or resilient walls 29 between the collection chamber 28 and the individual storage chambers 27.

The storage chambers 27 are arranged transversely to the longitudinal direction L side by side, thus extending in the longitudinal direction L. The collection chamber 28 is disposed below the storage chambers 27. During the long-term analysis, the storage chambers 27 gradually empty, while the collection chamber 28 fills with spent sensor solution and measured blood samples.

The individual chambers 27, 28 are not formed as independent bags but connected to each other via the flexible walls 29. Thus, they are not only in fluid communication with each other via the fluid exchange controlled by the valves 76, but the volumes also change in opposite directions in a positively coupled manner, so to speak.

These opposing volume changes cause the outer geometric dimensions of the collar 82 to change imperceptibly, so that it can be attached to the arm of a patient like a blood pressure cuff, without being affected by the change in volume.

In the outer skin 84 27 openings 85 are provided over areas of the storage chambers through which the storage chambers 27 are filled before they are closed with a cover sheet 86, so that the filled with sensor solutions 27a cuff 82 can be stored and transported.

Alternatively, the storage chambers 27 can also be filled bubble-free from one longitudinal side and then welded. The openings 85 and the cover sheet 86 are then not required, in this area is then also outer skin 84, in the placement of the Fluidik card 31 then the position of the openings 85 is set.

The storage chambers 27 are sealed in this way gas-tight relative to the ambient air, so that the sensor solutions 27a can neither outgas nor react with components of the ambient air, so are adequately protected for storage over at least several months.

When the fluidic card 31 is then slipped onto the sleeve 82 during the production of the patient module 21, the piercing tips 32 puncture the cover film 86 or the outer skin 84, so that a fluid connection between the storage chambers 27 and the channel 75 in the Fluidic card 31 is produced. At the same time the access port 33 comes into engagement with a provided in the outer skin 84, permanently open filling opening 87, which leads to the collection chamber 28.

However, the valves 76 of the fluidic card 31 are now still closed, so that the sealing of the storage chambers 27 is maintained and the patient module 21 can be stored and transported when the sensor card 35 has been attached to the fluidic card 31. The connection of the sensor card 35 and the fluidic card 31 can take place before or after the piercing of the piercing tips 32 into the storage chambers 27.

It is also possible to firmly connect the fluidic card 31 and sensor card 35 to the cuff 82 without the piercing tips 32 already connecting to the storage chambers 27. The patient module 21 thus formed can then be packaged in a sterile manner and stored on the patient until it is used. Only when snapping the measuring module 23, the piercing tips 32 are then pressed by the cover sheet 86 or the outer skin 84.

When the patient module 21 is discarded, the collection chamber 28 is also closed. The access port 33 is seated sealingly in the filling opening, so that the collecting chamber 28 is only in fluid communication with the channels 79, 77, 71, 75 and 74 in the fluidic card 13. The only access from the outside to the fluidic card 31 is the sample access 80, which, however, is closed by the normally closed valve 81.

The sleeve 82 thus serves both to provide the nested, variable volumes of storage chambers 27 and collection chamber 28 and as a carrier 26 of a diagnostic module 30, which is formed here by the fluidic card 31 and the sensor card 35.

The cuff 82 can be stored next to the patient in the patient area 17 as an adhesive pad below the blanket as well as attached to the upper arm of the patient. On its underside 88, the sleeve 82 may be provided for this purpose with an anti-slip coating and / or with a hook-and-loop fastener.

In use, the new device 10 can be placed in the patient area 17 because of its compactness, the access line 11 is connected either directly to the patient or to a tubing system which, in turn, is in fluid communication with the patient.

On the one hand, the compactness of the new device 10 results from the outsourcing of functions not required locally on the patient, such as control, evaluation, storage and display, as well as from the variable volumes of the chambers 27, 29.

While the electrical components can be largely miniaturized or outsourced, this is not possible for the sensor solutions. Long supply lines for the supply of such auxiliary media to the patient module prohibit because this may change the compositions of the sensor solutions, in particular the partial pressures of the dissolved gases. Furthermore, there is a risk that lines are disconnected, which also leads to possibly unnoticed incorrect measurements.

Because communicating volumes are now present in the cuff 82 as it were, and the cuff can be flat and elongate, larger volumes of sensor solutions can also be stored in the patient module 21.

For a long-term analysis, a few 100 g of sensor solutions are needed. This weight does not hinder a patient even when worn with an arm cuff.

About the control module 15, the measuring module 23 is driven at certain intervals so that whole blood is sucked and measured via the access line 11 into the measuring channel 71. Before and / or after each measurement on whole blood, the sensors 37 are rinsed and / or calibrated via sensor solutions 27a, which are stored in the storage chambers 27. Spent sensor solutions 27a and metered whole blood are then transferred by means of the pump 78 into the collection chamber 28, where it is gradually accumulated throughout the use of the new device 10.

The determination of the measurement times and the control of sampling from the patient or the tube system can either be done fully automated, and it is also possible outside the patient area, partially assisted by operating personnel to initiate the sampling.

For this purpose, for example, the liquid from the patient line 65 is sucked into a syringe until the required for the invasive pressure measurement fluid and diluted blood so far from the patient line 65, which connects the patient 12 with the invasive pressure measuring system 66, retracted, that at the sampling point 68 is pending full blood.

By manually entering a signal on the display module 16 or the control module 15, the operator can then indicate that a new whole blood measurement can be made in accordance with the already described method steps.

At the end of the measurements, which can take place over hours or days, but at the latest when the sensor solutions 27a are consumed in the storage chambers 27, the measuring module 23 is removed from the patient module 21, cleaned and stored until it is reused is supplied.

The patient module 21, however, is disposed of, it is not designed for reuse for hygienic reasons but represents consumable material.

Claims

claims

1. A device for analyzing patient samples, comprising a patient module (21) which can be used only for a patient (12) and is equipped for receiving at least one patient sample and sensors (37) for recording measured values of the patient sample and at least one storage chamber (27) a sensor solution (27a) and with a reusable measuring module (23) which is mechanically detachable (83) connected to the patient module (21) and the measured values of the sensors (37) decreases, processes and supplies to a determination of physiological patient parameters, characterized in that the patient module (21) and the measuring module (23) are adapted to remain mechanically connected to each other during the recording and analysis of at least two successively taken patient samples.

2. Apparatus according to claim 1, characterized in that the measuring module (23) via at least one of a patient area (17) can be led out compound (13) to a computer unit (14) for displaying and / or storing the specific patient parameters.

3. Device according to claim 2, characterized in that the connection (13) comprises a multiple line (13), the pressure lines (55) for controlling an actuator in the patient module (21) and electrical lines (50) for transmitting control signals to the Measuring module (23) and of measured values of the measuring module (23).

4. Device according to one of claims 1 to 3, characterized in that within the patient module (21) at least one pump (78) is provided, which is switchable via at least one valve (81) with a sample access (80) in fluid connection ,

5. Device according to one of claims 1 to 4, characterized in that the patient module (21) with only one access line (11) is connectable, get over the patient samples in the patient module (21).

6. Device according to one of claims 1 to 5, characterized in that the patient module (21) comprises a carrier (26) and a diagnostic unit (30) supported therefrom, wherein the carrier (26) the at least one storage chamber (27), and the diagnostic unit (30) contains the sensors (37).

7. The device according to claim 6, characterized in that the carrier (26) includes a collection chamber (28) for spent sensor solutions (27a) and analyzed patient samples.

8. Apparatus according to claim 6 or 7, characterized in that the diagnostic unit (30) includes a fluidic card (31), in which a measuring channel (71), at least one connected to the measuring channel pump (78), valves (76, 81), a connection (32) to the at least one storage chamber (27) and a sample access (80) are provided, via which the patient samples enter the patient module (21).

9. Device according to one of claims 6 to 8, characterized in that the diagnostic unit (30) includes a sensor card (35), on one side (36) of the sensors (37) and on the other side (38) an interface ( 22) are provided for connection to the measuring module (23).

10. The device according to claim 8 or 9, characterized in that the connection (32) to the storage chamber (27) comprises a piercing tip (32), which when placing the fluidic card (31) or the measuring module (23) a cover film ( 84, 86) pierces, which closes the storage chamber (27).

Patient module for a device (10) according to any one of claims 1 to 10, comprising a support (26) comprising at least one storage compartment (27) for sensor solution (27a) and a diagnostic unit (26) attached to the support (26). 30) containing sensors (37) and to which a measuring module (23) can be plugged.

12. fluidic card for a patient module (21) according to claim 11, in which at least one pump (78) is provided, which is switchable via at least one valve (81) with a sample access (80) in fluid communication.

13. Measuring module for a patient module (21) according to claim 11, with a multiple line (13) for connection to a computer unit (14), and with an interface (22) for connection to the diagnostic unit (30).

14. Computing unit for the measuring module (23) according to claim 13, with a control module (15) for controlling the measuring module (23) and the diagnostic unit (30).

System having a patient module (21) according to claim 11, a measuring module (23) according to claim 12 and a computer unit (14) according to claim 14.