DE102012201390A1 - Sensor arrangement for vacuum therapy system for healing wound of patient, has sensor elements which provide measurement signal comprising information regarding composition and amount of component of transported secretions of wound - Google Patents

Abstract

The sensor arrangement (50) includes sensor elements (50-1,50-2) which are attached to the hose system (30) carrying the transported secretions of wound (W). The sensor elements are configured to provide a measurement signal comprising information regarding the type, composition and/or amount of component of the transported secretions of wound, when the sensor elements perform physical or chemical interaction with components of the transported secretions of wound. The sensor element is provided with an indicator dye which is embedded into polymer material. Independent claims are included for the following: (1) vacuum therapy system; and (2) method for analyzing liquid or gaseous secretion of wound of patient.

Description

Embodiments of the present invention relate to the most efficient monitoring of wound healing processes of patients, and more particularly to a sensor arrangement for a vacuum therapy system, to a vacuum therapy system with sensor functionality and to a coupled method for analyzing a fluid or gaseous (fluidic) secretion of a wound of a patient.

In the field of medical technology, the monitoring of wound healing processes of patients who have an "open" wound as a result of a medical intervention (operation), an accident or a disease is an important therapy-accompanying measure in order to achieve wound healing as quickly as possible, z. As a result of infection of the wound, intervene and targeted to initiate appropriate countermeasures or treatments early.

To assist the wound healing process, for example, the so-called "vacuum therapy", which is also referred to as vacuum sealing (vacuum assisted closure therapy - "VAC" or negative pressure wound therapy "NWPT") used for wound healing. The vacuum therapy for wound healing of a patient is based on the application of a slight negative pressure on an open wound in order to promote their healing.

Such a system generally consists of a material for wound closure (occlusion) and a device for applying the negative pressure and for removing the wound fluid (exudate or transudate). The latter device consists of a tube system, which exerts a negative pressure on the wound via a vacuum pump and pumps the wound fluid into a container. To apply this therapy, a special dressing material or a foam is adapted to the contours of the wound and sealed with a transparent film. The suction tube is connected to the dressing material via an opening in the foil. Thus, a negative pressure can be applied to the wound. In this way, an open, closed wound is created and at the same time excess wound secretions are pumped out.

The object of the present invention is to provide an improved concept for monitoring a wound healing process of a patient, which allows a treating or medical staff or the patient himself to monitor the healing process of a wound as simply as possible in order to timely and targeted to a to be able to react to any change in the healing process.

This object is achieved by a sensor arrangement for a vacuum therapy system according to claim 1, a sensor-based vacuum therapy system according to claim 14 and a method for analyzing a liquid or gaseous secretion from a wound of a patient according to claim 22.

Inventive developments are defined in the subclaims.

An embodiment according to the present invention provides a sensor assembly for a vacuum therapy system adapted to apply a vacuum to a wound and to evacuate a liquid or gaseous discharge from the wound, the sensor assembly comprising a sensor element configured to be based on a vacuum physical or chemical interaction with at least one component of the transported away secretion to provide a measurement signal which has information regarding the nature, composition and / or amount of the component to be examined in the transported away secretion. According to the invention, therefore, the vacuum therapy is coupled with a sensor.

Another embodiment of the present invention provides a vacuum therapy system with sensor functionality comprising an occlusion member adapted to provide at least a partial hermetic closure of a wound, a tubing system configured to remove a liquid or gaseous secretion from the wound, a pump assembly, which is designed to exert a negative pressure on the wound via the tube system and the occlusion element, and to effect the removal of the liquid or gaseous secretion from the wound, and a sensor arrangement for providing the sensor functionality, the sensor arrangement having a sensor element is designed to provide a measurement signal S _mess based on a physical or chemical interaction with at least one to-be-examined part of the transported away separation, the information with respect to kind, co Composition and / or amount of the substance to be examined in the transported away secretion has.

Another embodiment of the present invention provides a method for analyzing a liquid or gaseous secretion from a wound of a patient, wherein a negative pressure on the wound of the patient by means of a Vacuum therapy system is applied to transport the liquid or gaseous exudate to be examined from the wound via a tube system, and wherein a physical or chemical interaction of the at least one to-be-examined component of the evacuated secretion by means of a sensor element, which is integrated in the tube system of the vacuum therapy system detected is to provide a measurement signal having information regarding the type, composition and / or amount of the component to be examined in the transported away secretion.

The gist of the present invention is that patient monitoring of a wound healing process is very efficient and i. W. can be performed in real time by providing a sensor functionality on an apparatus for performing a vacuum therapy (on an open wound of a patient). Thus, the component of the evacuated wound secretion to be examined can be brought into direct contact with the sensor element and evaluated, based on a physical or chemical interaction between the arranged on the vacuum therapy system sensor element and the transported away, liquid or gaseous secretion from the wound of the patient, a measurement signal provide. The measurement signal now has information regarding the type, composition and / or amount of the constituent to be investigated in the transported-off secretion.

A suitably designed vacuum therapy system now has in the form of the sensor element and optionally with an associated evaluation and display on a monitoring or control functionality to selectively via the examination of one or more components of the evacuated discharge from the wound almost in real time accurate information about the To obtain wound healing process.

So a positive change, i. H. an advance, or even a negative change, d. H. a deterioration of the wound healing process to a change in the nature, composition and / or amount of one or more different components of the secreted secretion of the wound. These components or their changes can now be detected directly (ie almost in real time) and very selectively by means of the sensor arrangement integrated in the vacuum therapy system. In this way, it is possible to react in a very targeted and timely manner by means of the measurement signal provided by the sensor element to a change in the wound healing process which can be detected by the nature, composition and / or amount of the constituent to be investigated in the secretion removed. The concept according to the invention now makes it possible to directly analyze one or more constituents of the transported-off secretion (of the exudate or transudate) or of the gaseous substances removed, so that exact conclusions about the course of healing can be obtained directly about the examined constituent, with a very high selectivity and also reliability the wound can be pulled. Thus, for example, occurred and recorded problems, eg. B. in the form of infections, counteracted with targeted countermeasures in the form of a suitable treatment and / or medication. Accordingly, the medication can be automatically reduced in a treatment progress to keep the burden on a patient as low as possible. This is particularly advantageous in intensive care.

According to the invention, therefore, the extracted, liquid and / or gaseous substances or the constituents to be examined present in a system for vacuum therapy are used directly for monitoring and controlling the healing process of a wound. This is achieved by incorporating or integrating individual sensors, a plurality of sensors, sensor arrays or also any desired combinations thereof for the determination and quantification of relevant analytes in a vacuum therapy arrangement, since the constituents to be investigated are present there immediately. The respective sensor element for a vacuum therapy system can now be selected as sensor single element or sensor array from different types of sensor elements in order to provide an optically and / or electrically evaluable measurement signal. Alternatively, the sensor element itself as a display of the measurement signal as a so-called "indicator element" z. Example, with an indicator dye or indicator nanoparticles or indicator microparticles are used to a perceptible or detectable change of an optical property based on the type, composition and / or the amount of the component to be examined in the transported away secretion, d. H. z. B. a color and / or brightness change, the indicator element to provide.

A significant advantage of the sensors and arrays described herein in vacuum therapy devices is the simplicity and versatility of these systems. Especially with optical sensor systems important parameters of wound healing can be recorded and quantified online and non-invasively. The use of such systems allows both physicians and medical staff, as well as the patient to monitor the course of wound healing very effectively and easily.

The use of electronic and electrochemical sensors and sensor arrays allows easy and direct output of measurement results on digital displays (eg LCD screens) and computers. The measured concentration of the corresponding analyte can be read directly or any optical, acoustic and / or haptic (warning) signals can be output. In particular, pattern recognition with respect to the components to be examined can also be carried out with a sensor array. In addition, the components to be examined can be provided very easily via an interface externally for further processing.

The implementation of optical sensor systems impresses with its simplicity and clear signal effect. Exceeding limit values or the presence of certain undesired parameters and analytes can be displayed directly via a (clearly perceptible) color change (eg from green to red). Due to the nature of the indicator system, the range of the color change can be adjusted. In this way it is possible to produce test strips and sensors for many different measuring ranges. By choosing the matrix polymer and its layer thickness, the measuring range can be finely adjusted and thus adapted to the requirements of the application. In addition, selectivity can be induced via the porosity or diffusion properties of the polymer so that cross sensitivities can be minimized. Furthermore, by embedding or binding the indicators into or onto suitable polymer particles in nm or μm size, a plurality of indicator dyes can be introduced into a sensor layer or a test strip. In this way, multiple analytes can be detected in parallel in a test strip or sensor.

A major advantage of micro- and nanoparticles is their significantly improved processability over other formulations, as evidenced by their good processibility in roll-to-roll processes, ink-jet printing and extrusion. This is a big step forward in terms of low cost manufacturing of the sensors and test strips.

Preferred embodiments of the present invention will be explained below with reference to the accompanying drawings. Show it:

1 a schematic schematic diagram of a vacuum therapy system with sensor functionality and a sensor arrangement according to an embodiment of the present invention;

2 a schematic schematic diagram of a vacuum therapy system with sensor functionality and a sensor arrangement according to another embodiment of the present invention;

3 a schematic schematic diagram of a vacuum therapy system with sensor functionality and a sensor arrangement according to another embodiment of the present invention; and

4 a basic process flow for a method for analyzing a liquid or gaseous secretion from a wound of a patient.

Before the present invention is explained in more detail in detail with reference to the drawings, it is pointed out that identical, functionally identical or equivalent elements in the figures are provided with the same reference numerals, so that the description of these elements shown in different embodiments is interchangeable can be applied.

The following will now be based on 1 the basic arrangement and operation of a sensor arrangement according to the invention 50 for a vacuum therapy system in connection with the elements of a vacuum therapy system 100 with sensor functionality according to an embodiment of the present invention.

As in 1 is shown, the vacuum therapy system 100 with sensor functionality a so-called "occlusion element" (wound closure element) 20 configured to provide, at least in part and, for example, completely, a hermetic seal of a wound "W" on a body part "K" of a patient. The wound may be located on any body part or extremity of a living being, ie a human or an animal. For the occlusion element 20 For example, a special dressing material or a foam material adapted to the contours of the wound and with a z. B. transparent film (at least partially or completely) hermetically sealed or sealed. The vacuum therapy system further includes a tube system 30 with, for example, several tube sections 30-1 . 30-2 , The hose system 30 with an (optional) collecting container 35 is now designed to carry away a liquid or gaseous (fluidic) secretion from the wound and, for example, to the collecting container 35 to convey (or, for example, just to deliver to the environment after the sensor array).

An end portion of the hose section 30-1 of the hose system 30 will now have an opening 20-1 in the film of the occlusion element 20 on the dressing material and thus on the occlusion element 20 itself connected or fluidly connected. A pump arrangement 40 , which is designed for example as a vacuum or vacuum pump, is now provided to a negative pressure (negative pressure) over the hose section 30-1 of the hose system 30 and the occlusion element 20 to exercise on the wound. In this way, the removal of the liquid or gaseous secretion from the wound into the collecting container 35 be effected.

Thus, an intermittent, continuous, constant or permanent vacuum (or a certain negative pressure) is applied to the wound in order to produce an artificially closed wound from the open wound and at the same time to pump out or remove excess wound secretion or gaseous secretions. At the removal path of the liquid or gaseous discharge from the wound, a sensor arrangement is now according to the invention 50 to provide a sensor functionality for the vacuum therapy system 100 provided to the transported away from the wound, liquid or gaseous secretion or certain to be examined constituents of the removed secretion in contact with a sensor element 50-1 the sensor arrangement 50 bring to. Based on a physical or chemical interaction between the sensor element 50-1 and the at least one component of the transported-off secretion to be examined is now provided with a measurement signal S _Mess which is optically and / or electrically readable or evaluable. The sensor element 50-1 is now formed in particular, so that the measurement signal S _measurement has information regarding the type, composition and / or amount of the component to be examined in the transported away secretion.

According to the invention, such sensor elements 50-1 in the vacuum therapy system 100 can be used, which make it possible that the extracted, gaseous or liquid substances, that can be detected and quantified the components to be examined of the transported away secretion. For example, oxygen, reactive oxygen species (including hydrogen peroxide), pH, CO ₂ , amines, carboxylic acids, ketones, Na ⁺ , K ⁺ , Ca are considered as relevant components to be examined (analytes) that permit a conclusion on the wound healing process ²⁺ , Mg ²⁺ , saccharides, alcohols, diols, thiols, nitrogen oxides, proteins, metabolites, organophosphorus compounds and amino acids, to name but a few or a selection of possible analytes.

The sensor element 50-1 It may now be designed to provide an optically and / or electrically readable or evaluable signal S _Mess based on the physical or chemical interaction with the at least one component of the transported-off secretion to be examined. For example, for the hose system 30 ie the individual tube sections 30-1 . 30-2 and the collecting vessel 35 , materials used (at least partially) can be made transparent, the sensor assembly 50 or the sensor element 50-1 be formed as an optical sensor system in the form of an optical sensor (optoelectronic sensor) or an indicator element with an indicator dye or indicator particles.

In addition, even more sensor elements for the sensor arrangement 50 be used, such. For example, a sensor element based on RNA or DNA recognition, fluorescent proteins, antigen-antibody interactions, DNA chips in general, sensor elements based on molecularly imprinted polymers, ELISAs (Enzyme Linked Immunosorbent Assay), sensor elements based on (surface-enhanced) Raman scattering or others optical measuring methods such as IR absorption, an amperometric sensor element, a conductive sensor element, a voltammetric sensor element, a cyclic voltammetric sensor element, a polarographic sensor element, a potentiometric sensor element, a coulometric sensor element, a sensor element with ion-sensitive electrodes, and / or a chemically sensitive semiconductor component ( or combinations or arrays thereof). The sensor element 50-1 is thus provided to the measurement signal S _mess , which is optically and / or electrically evaluable to provide. Alternatively, the sensor element itself can be effective as a display device for reproducing the measurement signal S _mess .

In the following, some of the measuring principles of sensor elements which can be used according to the invention are described by way of example. The following list is only to be regarded as exemplary and not as conclusive.

In the generation of an optical and / or electrically readable or evaluable measurement signal based on a physical or chemical interaction between the sensor element and at least one component to be examined of the transported away secretion, for example, physical measuring methods, such. B. by exploiting molecular properties for the detection of molecular mass, diffusion behavior, molecular structure, molecular stability and molecular mobility are performed, or chemical measurement methods that exploit chemical Properties such as reactivity, polarizability, intrinsic optical properties (eg, optical rotation), oxidizability, and reducibility are carried out.

Thus, in the case of a resistive sensor element (chemo-resistor), the gaseous or liquid analyte to be measured directly influences the conductivity of an analyte-sensitive sensor layer. This resistance change serves as a measured variable. Examples include an inorganic metal oxide semiconductor (MOX), organic phthalocyanine, carbon nanotubes or a conductive polymer material. In the case of a conductive sensor element, a measurement of the electrical conductivity is carried out as a function of the constituent of the transported-off secretion. In a second-wire embodiment of a sensor element, there are two measuring electrodes on the sensor element. When in contact with a conductive fluid, i. H. the component of the transported away secretion, then flows between the two measuring electrodes, a measuring current, which can be evaluated and output, for example, as a switching signal.

In the case of a capacitive sensor element, the measured variable is the capacitance of a capacitor, which is influenced by a gas- or liquid-sensitive dielectric. An example of this is a polymer sensor for measuring moisture. In a potentiometric sensor element, a voltage is generated by the sensor element itself, which is directly measurable. Examples include a solid-state ion conductor (lambda probe) or a chemo-transistor (polymer field effect transistor).

In an amperometric sensor element, a measurable current is supplied by the sensor element itself. Examples include an electrochemical cell (Clark electrode, fuel cell), a flame ionization detector or a photoionization detector. In a voltammetric sensor element, an electrical charge is measured by the sensor element. In a cyclic voltammetric sensor element, an analytical method using, for example, a triangular voltage method is used to obtain an overview of various electrode processes. In a polarographic sensor element, an electrochemical process is used for the qualitative and quantitative analysis of chemical elements and compounds, i. H. especially of ions and molecules in a solution. While working with voltammetry with stationary electrodes, for example, mercury drop electrodes are used in polarography.

In the case of a thermal sensor element, a temperature increase due to a chemical reaction at the sensor surface is measured or the thermal conductivity of the analyte to be investigated is used directly as a measured variable. In a thermochemical sensor element, chemical reactions take place on the sensor surface in which energy is released in the form of heat. This temperature is measured. An example of this is a catalytic converter (eg pellistor). In a thermal-physical sensor element, a direct measurement of the thermal conductivity of the analyte to be examined is carried out. An example is a thermal conductivity sensor.

In a gravimetric sensor element, a mass change is measured. Molecules of the analyte to be examined are deposited, for example, on the surface of a quartz crystal and thereby change its resonant frequency. Such sensor elements work, for example, on the principle of a piezoelectric sensor. Examples are quartz crystal microbalances or SAW sensor elements.

In the case of optical sensor elements, physical principles are exploited in which the optical properties of a sample space filled with the analyte to be investigated are characterized. As examples are the refractive index, opt. Activity (rotation), reflection, turbidimetry, nephelometry, IR spectroscopy, the absorption properties (wavelengths, intensity, circular dichroism, or luminescence properties (wavelengths, intensity, cooldown, anisotropy) to name.

In biochemical sensor elements, the implementation of certain substances or groups of substances is exploited. In a coulometric sensor element, a procedure is used to determine the quantitative amount of substance of an oxidizable or reducible compound.

In a sensor element with ion-sensitive electrodes, the potential measured at the ion-sensitive electrodes is dependent on the concentration or activity of a particular type of ion. Such an electrode consists in principle of an electrode which does not participate in the electrochemical reaction, z. As a graphite electrode, and an associated electrode phase, which consists in the simplest case of a sparingly soluble salt with the ionic species, which is in equilibrium with the corresponding ion in the solution.

For chemically sensitive, such. B. ion-selective or ion-sensitive conductor components, such. B. an ion-sensitive field effect transistor (ISFET), for example, a special Field effect transistor used, for example, can measure the pH of a solution by the electrical conductivity of the transistor. Just like the field effect transistor, the measuring principle is based on a change in the field effect (ie the formation of a space charge zone), which is formed between the source and drain of the field effect transistor. Instead of the electrical contact at the gate, an ion-sensitive layer is applied, which is brought directly into contact with the liquid to be measured.

In the foregoing, only a small selection of sensor elements has been exemplified, which can be used according to the invention to provide an optically and / or electrically evaluable or readable measurement signal based on a physical or chemical interaction between the sensor element and the component of the evacuated secretion to be examined. The list above is to be considered as illustrative only, not as conclusive.

The following will now focus on possible implementations of the sensor arrangement 50 received, in which the sensor element of the sensor assembly 50 itself as a display device of the measurement signal is effective. Thus, the sensor element may be in the form of an indicator element having an optical characteristic or indicator dye or particles to be in contact with the indicator element based on the type, composition and / or amount of the component under investigation in the evacuated secretion , a perceptible or detectable change in the optical property z. B. in the form of a color and / or brightness change of the indicator element provides.

In this case, the change in the optical property of the indicator element 50 be reversible, for example, to continuously monitor the component to be monitored in the transported away secretion. Alternatively, the optical property of the indicator element may also be formed irreversibly, for example to achieve a limit value violation of the component to be monitored.

For example, the indicator element may include an indicator dye or indicator particle embedded in a polymeric material to obtain the optical property that depends on the component to be contacted and monitored. For example, the optical property may be dependent on a pH of ions, biomolecules and / or gases in the component to be monitored. Further, the indicator dye of the indicator member may be configured such that the optical property that selectively changes due to the contact with the analyte, an absorption wavelength, an absorption intensity, a circular dichroism, a reflection property, a transmission property, refraction, light scattering, polarization of the Light, an emission wavelength, an emission intensity, an emission decay time (fluorescence or phosphorescence decay time). Further, the indicator dye may be embedded in nanoparticles or microparticles or joined by covalent bonding to the polymer material or to nano / microparticles incorporated into the polymer material.

Thus, the sensor element formed as an indicator element 50-1 . 50-2 perform a control function, ie form a control that directly on the hose system 30 or the optional collection container 35 is arranged so that a control surface of the control element is visible and the component to be examined the transported away secretion with the control element during operation of the vacuum therapy system 100 comes into contact. In this case, the control element is now designed so as to cause a visible change in the control surface in a change in a property of the component to be examined, based on the chemical or physical interaction and thus an indication to the patient himself or for the treating person or the medical staff provide.

In addition, an analyte-selective cover structure or covering layer can be provided on the sensor element or indicator element, which is permeable only to certain constituents to be examined or to a specific constituent of the evacuated secretion to be examined. Thus, for example, the so-called cross-sensitivity of the sensor arrangement 50 be significantly reduced. Cross-sensitivity refers to the sensitivity of a sensor arrangement to variables other than the measured variable. That is, a variable that is not measured, but affects the information provided by the measuring device about the measured value is called influencing variable. It causes the measured value to change simply because the influencing variable changes. Of course, such cross-sensitivity should be kept as low as possible.

In summary, it can thus be stated that the presence of the substance to be determined can be indicated either by a color change or by other changes in the optical properties (brightness, emission wavelength, fluorescence, phosphorescence, etc.). For this purpose, indicator dyes or indicator dye particle systems can be introduced into a polymer matrix and immobilized on a support material become. The carrier material may also be the tube of the NWPT device itself. Furthermore, it is possible to embed the indicators or particles in the tube without additional polymer, to covalently bond directly to the substrate, the tube 30 or sections 30-1 . 30-2 to use it as an optical fiber (ie, as an optical fiber) or the optical fibers in the tube 30 incorporate. The indicator dyes interact (chemically, physically) with the analyte to be determined, causing a change in their optical properties. The change can be both reversible and irreversible.

The selectivity and the sensitivity of the indicators is determined by the materials used, such. As the molecular structure of the indicators, the properties of the polymers used and other components. An example of detection of amines is the trifluoroacetyl group-amine interaction. For example, receptors that cause a visible change in the control surface for reactive oxygen species can be redox systems, often using metal-ligand complexes, and the recognition reaction then occurs at the metal center. Metal-ligand complexes are also used for the fluorescent detection of oxygen. Fluorescein sulfonate groups are selective receptor groups for hydrogen peroxide, maleimide functions are selective receptor groups for thiols, tricyanovinyl groups are selective receptor groups for primary and secondary amines, pyrylium functions are selective receptor groups for aldehydes and ketones, amino groups are selective receptor groups for aldehydes and ketones, boronic acid functions are selective receptor groups for diols, 1,2-diaminobenzene groups are selective receptor groups for nitrogen oxides, aldehyde functions are selective receptor groups for amino acids.

The sensor materials can be made very flexible and in any shape and size in the hose 30 or the tube sections 30-1 . 30-2 of the device 100 integrated or applied. The reversible sensor formats allow continuous monitoring of the analytes, whereas irreversible systems z. B. indicate the exceeding of a certain limit.

The following is now based on the in 2 illustrated basic structure of another embodiment of a vacuum therapy system according to the invention 100 described with sensor functionality. As in 2 is shown, the vacuum therapy system now has the additional collection container 35 on, wherein in the collecting container 35 a sensor element 50-2 the sensor arrangement according to the invention 50 is arranged. This in 1 illustrated sensor element 50-1 the sensor arrangement 50 can in addition or alternatively to that in the collection container 35 arranged sensor element 50-2 from 2 be provided. Regarding the in 2 illustrated arrangement 100 It should be noted that identical, functionally identical or equivalent elements as in 1 are again provided with the same reference numerals, so that the description of these elements directly on the in 2 illustrated embodiment can be applied or interchangeable.

Like now in 2 is shown, the sensor element 50-1 . 50-2 the sensor arrangement 50 thus in every subelement 30-1 . 30-2 of the hose system 30 or in the associated collection container 35 or on an inner or outer wall thereof, the vacuum therapy system 100 arranged, integrated or trained.

So it is also possible sensor materials in the collecting vessel 35 of the NWPT device 100 to implement. At this point, the installation of non-optical sensor systems, such. As amperometric, conductive, voltammetric, cyclovoltammetric, polarographic, potentiometric, coulometric sensors, ion-selective electrodes, field effect transistors of any kind, semiconductors, etc., relatively easy to implement, since the collecting vessel 35 firmly attached and not like the hose 30 z. B. needs to be flexible. In addition, here is the possibility of wiring to a power supply or power source (not shown in 2 ) and to an (optional) readout unit (not shown in FIG 2 ) facilitated. When using transparent materials for the collecting vessel can also optical sensor materials on the inside of the vessel 35 be attached.

The representation, handling and implementation of the sensors 50-2 in or on the vessel 35 runs according to the sensors 50-1 in the hose system 30 are attached. The indicator dyes or indicator dye particle systems can be applied directly to the collection vessel 35 bound or applied in suitable polymers on the surface. The procedure here is corresponding to the procedure for mounting the sensor systems 50-1 in the hose system 30 , sensors 50-2 in the collecting vessel 35 of the NWPT device 100 In addition, they offer the possibility of being aware of changes in the concentration of certain analytes, such as B. carbon dioxide, oxygen, biogenic amines, pH o. Ä. Back to shoot on the presence of bacteria in the exudate or transudate. When the concentration of these substances is changed, bacteria are present in the collecting container, resulting from incipient or unrecognized bacterial infection of the wound.

The following will now be based on 3 the basic arrangement and operation of a vacuum therapy system 100 with sensor functionality according to another embodiment of the present invention.

At the in 3 illustrated embodiment are again identical, functionally identical or equivalent elements as in the 1 respectively. 2 provided with the same reference numerals, so that the description of these elements directly on the in 3 illustrated embodiment can be applied or interchangeable and thus no re-description of these elements needs to be made.

Like now in 3 is shown, the vacuum therapy system 100 Furthermore, an evaluation device 60 which is configured to determine, based on the provided measurement signal S _mess or a signal derived therefrom, which has already been subjected to signal conditioning, amplification or the like, a determination of the type, composition and / or amount of the component to be examined in the transported To perform segregation. The evaluation device 60 is further configured to provide an _indication signal S _indication based on the determined type, composition, and / or amount of the ingredient to be tested in the evacuated secretion for further processing and display.

This is now a display device 70 which is designed to provide, based on the _indication signal S _display, an optical, acoustic and / or haptic (eg vibrating) display based on the type, composition and / or quantity of the component to be examined.

Optionally, the evaluation device 60 and the display device 70 in a common housing 80 be housed. Furthermore, the vacuum pump device can also 40 , the evaluation device 60 and the display device 70 be housed in a common housing. Furthermore, the evaluation device 60 and / or the display device 70 each be provided with a (electrical, optical or non-wired) communication interface to provide the measurement results, for example, an external device (computer, server, ...) available.

The following is now based on the in 4 illustrated general flowchart a method 200 for analyzing a liquid or gaseous secretion from a wound of a patient by means of a vacuum therapy system with sensor functionality. It is at one step 210 exerting a negative pressure on the wound of the patient by means of a vacuum therapy system in order to transport away the liquid or gaseous secretion to be examined from the wound via a tube system, and wherein in a further step 220 a physical or chemical interaction of the at least one constituent of the evacuated secretion to be examined is detected by means of a sensor element integrated in the tube system of the vacuum therapy system, in order to provide a measurement signal containing information regarding the type, composition and / or amount of the constituent to be investigated in the transported away separation.

According to the invention, sensory units and devices are integrated into devices for vacuum therapy in order to control the wound healing process directly via the transported-off wound secretion and its interaction with the sensor system integrated in the vacuum therapy device. The sensor arrangement for a vacuum therapy system, the sensor-based vacuum therapy system and the analysis method according to embodiments of the present invention are thus extremely advantageous for monitoring wound healing in vacuum therapy, blood analysis, exudate or transudate and gaseous secretions in vacuum therapy with concomitant diagnosis be used by any diseases or infections and also generally for patient monitoring.

Although some aspects have been described in the context of a device, it will be understood that these aspects also constitute a description of the corresponding method, so that a block or a component of a device is also to be understood as a corresponding method step or as a feature of a method step. Similarly, aspects described in connection with or as a method step also represent a description of a corresponding block or detail or feature of a corresponding device.

Another embodiment includes a processing device, such as a computer or a programmable logic device, that is configured or adapted to perform one of the methods described herein. Another embodiment includes a computer on which the computer program is installed to perform one of the methods described herein.

Claims (22)

Sensor arrangement ( 50 ) for a vacuum therapy system ( 100 ), to exercise a negative pressure is formed on a wound and for the removal of a liquid or gaseous secretion from the wound, wherein the sensor arrangement ( 50 ) a sensor element ( 50-1 . 50-2 ), which is designed to provide a measurement signal (S _mess ) based on a physical and / or chemical interaction with at least one constituent to be examined, which contains information regarding the type, composition and / or amount of the constituent to be investigated the transported away separation. Sensor arrangement according to claim 1, wherein the sensor element ( 50-1 . 50-2 ) is selected from the following group of sensor elements in order to provide the measurement signal (S _mess ) which can be evaluated optically and / or electrically, the group comprising an optical sensor element in the form of an optical sensor or an indicator element, an amperometric sensor element, a conductive sensor element , a voltammetric sensor element, a cyclovoltammetric sensor element, a polarographic sensor element, a potentiometric sensor element, a coulometric sensor element, a sensor element with ion-selective electrodes, and / or a chemically sensitive semiconductor component. Sensor arrangement according to claim 1 or 2, wherein the sensor element ( 50-1 . 50-2 ) itself as a display device of the measurement signal (S _mess ) is effective. Sensor arrangement according to claim 3, wherein the sensor element ( 50-1 . 50-2 ) in the form of the indicator element has an indicator dye or nano / microparticles to provide a change in an optical property of the indicator element based on the type, composition and / or the amount of the component to be examined in the transported away secretion. Sensor arrangement according to claim 4, wherein the change of the optical property of the indicator element for continuous monitoring of the component to be monitored is reversible. Sensor arrangement according to one of claims 2 to 4, wherein the optical property of the indicator element for monitoring a limit value violation of the component to be monitored is irreversible. A sensor assembly according to any one of claims 2 to 6, wherein the indicator element comprises an indicator dye embedded in a polymeric material to obtain the dependent optical property that depends on the component to be contacted and monitored. Sensor arrangement according to claim 7, wherein the optical property of a pH, ions, molecules and / or of gases in the component to be monitored is dependent. A sensor arrangement according to claim 7 or 8, wherein the indicator dye is such that the optical property which selectively changes due to the contact or interaction with the component to be examined is an absorption wavelength, an absorption intensity, an emission wavelength, an emission intensity or an emission decay time , Sensor sensor array according to any one of claims 7 to 9, wherein the indicator dye is incorporated in nano- or microparticles and / or by means of a covalent bond to the polymer material or to a nano / microparticle, which is introduced into the polymer material, attached. Sensor arrangement according to one of claims 2 to 10, wherein the indicator element ( 50-1 . 50-2 ) is formed as a control element which is connected to the hose system ( 30 ), so that a control surface of the control element is visible and the component of the evacuated secretion to be examined is in contact with the control element, the control element being designed to respond to a change in a property or amount of the constituent to be assayed, based on the chemical or physical interaction to cause a visible change in the control surface. Sensor arrangement according to one of the preceding claims, wherein on the sensor element ( 50-1 . 50-2 ) is provided a cover structure or cover layer which is selectively permeable to the component to be examined. Sensor arrangement according to one of the preceding claims, wherein the sensor element ( 50-1 . 50-2 ) into a tube system ( 30 ) or an associated collecting container ( 30-3 ) is integrated. Vacuum therapy system ( 100 ) with sensor functionality, with the following features: an occlusion element ( 20 ), which is designed to provide an at least partially hermetic closure of a wound, a hose system ( 30 ), which is designed to remove a liquid or gaseous secretion from the wound, a pump arrangement ( 40 ), which is designed to be a negative pressure via the hose system ( 30-1 ) and the occlusion element ( 20 ) on the wound, and the removal of the liquid or gaseous secretion from the wound, and a sensor array ( 50 ) for providing the sensor functionality, wherein the sensor arrangement ( 50 ) a sensor element ( 50-1 . 50-2 ), which is designed to provide a measurement signal (S _mess ) based on a physical and / or chemical interaction with at least one constituent to be examined, which contains information regarding the type, composition and / or amount of the constituent to be investigated the transported away separation. A vacuum therapy system according to claim 14, wherein the sensor element ( 50-1 . 50-2 ) is selected from the following group of sensor elements in order to provide the measurement signal (S _mess ) which can be evaluated optically and / or electrically, the group comprising an optical sensor element in the form of an optical sensor or an indicator element, an amperometric sensor element, a conductive sensor element , a voltammetric sensor element, a cyclovoltammetric sensor element, a polarographic sensor element, a potentiometric sensor element, a coulometric sensor element, a sensor element with ion-selective electrodes, and / or a chemically sensitive semiconductor component. A vacuum therapy system according to claim 14 or 15, wherein the sensor element ( 50-1 . 50-2 ) itself as a display device of the measurement signal (S _mess ) is effective, wherein the sensor element ( 50-1 . 50-2 ) in the form of the indicator element has an indicator dye to provide a change in an optical property of the indicator element based on the type, composition and / or the amount of the component to be examined in the transported away secretion. A vacuum therapy system according to claim 15 or 16, wherein the indicator element is formed as a control element disposed on the tube system such that a control surface of the control element is visible and the component of the evacuated secretion to be examined is in contact with the control element, the control element being formed is to cause a visible change in the control surface upon a change in a property of the component to be examined, based on the chemical or physical interaction. Vacuum therapy system according to one of claims 14 to 17, wherein the sensor element ( 50-1 . 50-2 ) into a tube system ( 30 ) or an associated collecting container ( 30-3 ) is integrated. A vacuum therapy system according to one of claims 14 to 18, further comprising: an evaluation device ( 60 ), which is designed to carry out a determination of the type, composition and / or quantity of the component to be investigated in the transported-off secretion on the basis of the provided measuring signal or a signal derived therefrom. Vacuum therapy system according to claim 19, wherein the evaluation device ( 60 ) is further configured to provide an indication signal based on the particular type, composition and / or amount of the ingredient to be tested. A vacuum therapy system according to any one of claims 14 to 20, further comprising: a display device ( 70 ) configured to provide an optical, audible and / or haptic indication based on the indication signal based on the type, composition and / or amount of the ingredient to be examined. Procedure ( 200 ) for analyzing a liquid or gaseous secretion from a wound of a patient, comprising the following steps: 210 ) applying a negative pressure to the wound of the patient by means of a vacuum therapy system in order to transport away the liquid or gaseous secretion to be examined from the wound via a tube system, and detecting ( 220 a physical or chemical interaction of the at least one constituent to be examined of the evacuated secretion by means of a sensor element which is integrated in the tube system of the vacuum therapy system to provide a measurement signal which provides information regarding the type, composition and / or amount of the constituent to be examined in the has transported away secretion.

Images