EP3568169A1

EP3568169A1 - Device and method for wound treatment by means of negative pressure and delivery of a substance

Info

Publication number: EP3568169A1
Application number: EP18700540.0A
Authority: EP
Inventors: Martin Walti; Tobias HÄNGGI
Original assignee: Medela Holding AG
Current assignee: Medela Holding AG
Priority date: 2017-01-10
Filing date: 2018-01-05
Publication date: 2019-11-20
Also published as: WO2018130466A1; CA3046127A1; US11554205B2; US20190365961A1

Abstract

A device is made available for negative pressure treatment of wounds on the human or animal body, in which device, on the one hand, a substance is delivered to a wound bed (W) and, on the other hand, fluids such as in particular an exudate and the delivered substance are aspirated from the wound bed (W) by means of negative pressure. The device has a suction pump housing (2) and, arranged therein, a suction pump for aspirating the fluids from the wound bed (W), and a fluid collection container (3) for collecting the aspirated fluids. Moreover, the device has a first measuring means (30; 31; 25) and a second measuring means (5; 21; 24). The first measuring means (30; 31; 25) serves to determine the quantity of the aspirated fluids, and the second measuring means (5; 21; 24) serves to determine the quantity of the substance delivered to the body.

Description

TITLE DEVICE AND WELDING METHOD THROUGH UNDERPRESSURE AND SUPPLY OF A SUBSTANCE

TECHNICAL AREA

The present invention relates to a device for negative pressure treatment of wounds, in which on the one hand a substance is supplied to a wound bed and on the other hand by means of negative pressure fluids, such as in particular an exudate and the supplied substance are sucked out of the wound bed. Such devices are used in the medical field, in particular in the combined with instillation or irrigation negative pressure wound therapy. In addition, the invention relates to a corresponding method for the negative pressure treatment of wounds on the human or animal body.

STATE OF THE ART

In the medical field, it has been known for a long time that wound healing can be improved, in particular in the case of large and / or difficult-to-heal wounds, by means of negative pressure treatment of the wound bed (so-called NPWT - Negative-Pressure Wound Therapy). In this case, body fluids or secretions are sucked out of the wound bed by means of a pump. During the negative pressure treatment, the wound healing can additionally be positively influenced by supplying a substance to the wound bed. Such methods are known as negative pressure wound therapy with combined instillation or irrigation. Depending on the type and size of the wound, the suction and the supply take place simultaneously, one after another and / or alternately intermittently.

The substance to be supplied may be, for example, a physiological or non-physiological saline, a drug, or a mixture thereof. The substance can be used, for example, to promote wound healing, to prevent infections, to local anesthetics or to improve blood coagulation by inhibiting fibrinolysis. The delivery of the substance can thus serve for rinsing or therapeutic, diagnostic and / or preventive purposes.

General descriptions of the combined vacuum and instillation treatment of wounds can be found, for example, in the publication Bobkiewicz, Adam et al .; Negative pressure wound therapy with instillation (NPWTi): Current status, recommendations and perspectives in the context of modern wound therapy; Negative Pressure Wound Therapy Journal, [S.I.], v. Chr. 3, n. 1, apr. 2016; or in the publication Gupta, Subhas et al .; Clinical recommendations and practical guide for negative pressure wound therapy with instillation; Int Wound J, 2016 Apr; 13 (2): 159-174.

Often, for supplying the substance, similar to the conventional infusion, a liquid bag filled with the substance to be supplied or a bottle is placed elevated above the body site to be treated, so that the substance is supplied to the site to be treated by a supply line due to the hydrostatic pressure. Separately, the body fluids are sucked by a vacuum pump via a corresponding line.

In order to enable a better adjustment and control when supplying the substance, and / or to be independent of the arrangement and in particular the altitude of the liquid container filled with the substance, systems are also well known in which the supply of the substance to the body by means of a Pump, in particular a so-called peristaltic or peristaltic pump takes place.

To monitor the therapy, the pressure prevailing in the wound area is measured continuously or at regular intervals in many systems of the prior art. This is achieved for example by means of an auxiliary line, which opens laterally in the region of the patient-side end of the secretion line in this, or which is guided separately to the secretion line through the wound cover and directly to the wound area empties.

DE 10 2013 226 708 A1 discloses a system for the combined vacuum and instillation treatment of wounds with a vacuum unit and a separately provided instillation unit. Wireless communication ensures that the operation of the vacuum unit and the instillation unit are coordinated.

WO 2015/094724 discloses a device in which the pressure prevailing in the wound area is monitored in order to regulate the supply of the instillation fluid based thereon.

Other wound treatment devices in which fluid extraction is combined with instillation or irrigation and pressure monitoring is disclosed in documents WO 2005/105180 A1, EP 1 977 776 A2 and US 2013/021 1318 A1.

EP 0 865 304 Bl and US 2016/0045648 A1 each disclose devices for the negative pressure treatment of wounds, in which it is determined by means of a pressure measurement in the suction line whether the fluid collecting container is full or not. In the wound treatment device disclosed in EP 2 480 263 B1, pressure monitoring in the suction line is used to detect deviations from the normal course of treatment in order to trigger an alarm if necessary. Further, some prior art documents are listed below, each of which, however, relates to other medical fields than the vacuum wound treatment combined with instillation or irrigation.

WO 2015/086857 A1 discloses a system for rinsing a pericardial cavity, in which the rinsing process is regulated based on the flow rates of the supplied and discharged fluids measured by sensors in conjunction with the hematocrit value and a pressure measurement in the wound space. In US 2010/0259283 Al, the determination of the filling level in a container of an implantable medicament supply device is proposed by means of a measurement of the electrical resistance. In WO 2010/033272 AI a device is disclosed, which is used in a medical emergency for rapid extraction of internal fluid collections. In this case, a liquid is simultaneously supplied to the rinse. The quantities of the supplied and extracted liquids are measured and evaluated.

PRESENTATION OF THE INVENTION

It is an object of the present invention to provide a device for the wound or wound underpressure treatment combined with instillation or irrigation, by means of which the processes occurring during the treatment can be better monitored and, in particular, controlled. To solve this problem, a device is proposed, as indicated in claim 1. In addition, a method for negative pressure treatment of wounds is specified in claim 16. Advantageous embodiments of the invention are specified in the dependent claims.

The present invention thus provides a device for healing of wound tissue by means of negative pressure treatment of wounds on the human or animal body, in which on the one hand a substance is supplied to a wound bed and on the other hand by means of negative pressure fluids, in particular an exudate and the added substance, from the wound bed be sucked off. The device comprises a suction pump housing with a suction pump disposed therein for sucking the fluids out of the wound bed and a fluid collection container for collecting the extracted fluids. The device also has a first measuring device for determining the amount of extracted fluids and a second measuring device for determining the amount of the substance supplied to the body.

The device is thus combined with the negative pressure treatment of wounds Instillation or irrigation trained. During treatment, the wound bed is thus supplied with a substance. At the same time or offset in time be sucked by the suction pump fluids from the wound area. The fluids which are aspirated may be, in particular, body fluids, such as exudate, which forms in the wound bed. However, the fluids may also include at least a portion of the substance supplied to the wound bed.

The term "quantity of the extracted fluids" and the "amount of the substance supplied to the body" are understood to mean, in particular, the current or, over a certain period of time, averaged volume flows of the fluids or of the substance. But in particular also the weight or the volume of the fluids sucked up to a certain time or the substance supplied up to a certain time is meant. By means of the first and second measuring device, a physical parameter directly related to the volume or weight of the aspirated fluids or of the added substance is thus measured in each case.

While in many generic devices of the prior art, the prevailing in the wound area pressure is determined to monitor and control the negative pressure treatment, so for this purpose according to the invention, the extracted fluid and the amount of the supplied substance determined. Of course, an additional pressure measurement can be carried out especially in the wound area in order to further optimize the monitoring and control. In particular, the amount of substance absorbed by the body and / or the exudate secreted by the body in the wound area can be determined precisely by measuring the quantities of fluid or substances. It can be ensured, for example, that the substance supplied does not remain in the body, which is particularly important in relation to irrigation, when a fluid substance is supplied to the body over a relatively long period of time. However, the determination of the fluid or substance quantities can also only serve to prevent overpressure in the wound area. Recognizing bleeding that is a major problem in NPWT therapy is another very beneficial option. In any case, the determination of the amounts of fluid or substances by the first and second measuring device allows a direct inference to the actually relevant for the treatment parameters, whereby an improved Monitoring and control of the treatment process is enabled.

The vacuum treatment according to the invention is usually a process which lasts for several hours and may even take several days or weeks. As a rule, the vacuum treatment lasts so long that at least the possibility of healing is given to the wound tissue, or at least until a treatment-related healing process can be ascertained or possibly ruled out. The healing process is generally characterized in particular by a change in the wound tissue.

The substance supplied to the wound bed may be, for example, a physiological or non-physiological saline solution, a drug or a mixture thereof. The instillation substance may also serve to rinse the wound bed. However, it can also be used to introduce a drug or to locally anesthetize the wound area. In this case, the instillation substance can optionally be preconditioned, for example, with a defined temperature, UV radiation and / or a specific chemical composition or mixture.

In particular, the device may also have a substance container which serves to provide the substance to be supplied. The substance container may be made of a flexible or a rigid material. Advantageously, however, it is made of a transparent material, so that from the outside of the level is clearly visible.

The suction pump is preferably a vacuum pump, in particular a diaphragm pump. As a rule, a membrane pump has at least one membrane and a pump chamber which is limited by this. When using a membrane pump results in the wound area usually an oscillating pressure curve, which is due to the periodic pumping movements. Such an oscillating pressure curve can have a positive effect on wound healing. Of course, provision can be made to avoid the oscillating pressure curve caused by the pumping movements in the wound area, so that the negative pressure applied to the wound bed is in each case substantially equalized, ie averaged, during a cycle of the diaphragm pump. The pumping chamber is advantageous completely arranged inside the suction pump housing.

Preferably, the device for the intermittent suction of the fluids is formed, that is, the suction has interruptions, during which there is no fluid suction. It has been shown that intermittent suction can have a positive effect on wound healing. The time intervals during which the suction takes place are preferably many times longer than the time intervals during which no suction takes place. Depending on the size and type of wound, the suction intervals advantageously last from one to six hours and the intervals during which no suction takes place preferably from one to 30 minutes. The choice of intervals in these areas leads to a particularly rapid wound healing. The suction cycle with Absaugintervall and interval without suction is usually repeated several times, that is at least twice, but advantageously at least three times, and particularly advantageous at least five times repeated.

Preferably, the device, in addition to the intermittent suction or alternatively, is designed for the intermittent supply of the substance to the wound area. Particularly advantageous for wound healing is a device which is designed both for intermittent suction and for intenriittierenden substance supply. The intermittent suction then preferably has a periodicity which is tuned to the periodicity of the intermittent supply of the substance. In order to allow an optimal effect of the supplied substance on the wound tissue, the direction is preferably designed to supply the substance immediately before interrupting the suction and then during a time interval of advantageously 1 to 30 minutes, not only the suction, but also the substance supply suspend.

The device can have an optical or acoustic display by means of which the course or status of the treatment can be displayed based on the quantity of the extracted fluids determined by the first measuring device and / or the quantity of the supplied substance determined by the second measuring device. For example, an alarm may be displayed when the fluid collection container is full, the fluid dispensing container (instillation container) is empty, or the amount supplied and / or aspirated below or above certain predefined values. It is also possible that an alarm will be displayed if, for example, bleeding is detected in the wound area, which may be of great importance, especially in cardiac surgery applications. The displayed course or status and in particular the alarm triggering are preferably based on a comparison or a calculation in the sense of a mathematical combination of the quantities respectively determined by the first and the second measuring device. The mathematical combination can in particular comprise a difference formation between the quantities determined by the first and the second measuring device. By means of ascertaining the difference between the quantities of fluid supplied and withdrawn, it is possible, for example, to detect or prevent a so-called pooling. During pooling, less fluid is sucked off than supplied, resulting in a disadvantageous fluid pool in the wound area during the course of therapy.

In a particularly preferred embodiment, the device also has a connectable to the first measuring device and the second measuring device control unit for controlling the suction pump. The connection of the control unit with the first and second measuring device can be realized wired or wireless. The connection serves to establish a data communication between the control unit and the first or second measuring device, so that the quantities determined by the first and the second measuring device can be forwarded to the control unit.

Preferably, the control unit is designed to control the suction pump based on the determined by the first measuring device amount of the extracted fluids and / or on the determined by the second measuring device amount of the supplied substance. The control can be carried out by the control unit, for example on the basis of predefined limits for the extracted fluid quantity and / or the added substance amount, so that the suction pump performance is adjusted when exceeding or falling below these limits by the determined by the first and second measuring means amounts , Preferably, however, the control unit is designed to regulate the suction pump power based on a comparison or a calculation in the sense of a mathematical combination of the quantities respectively determined by the first and the second measuring device. In this case, the control unit in particular be designed to determine the difference of the specific amounts of extracted fluids and supplied substance and to control the suction pump based on this determined difference. In this way, optimal control of the suction pump can be achieved.

The control unit is advantageously designed to control the suction pump, that it increases the suction power of the suction pump when the amount of the supplied substance is greater than the amount of extracted fluids. It is also advantageously designed to gradually reduce the suction power of the suction pump when the amount of extracted fluids and in particular of the exudate becomes smaller in the course of the vacuum treatment.

Advantageously, the control unit is arranged inside or on the suction pump housing. The second measuring device can likewise be arranged inside or on the suction pump housing. In this case, it can be provided, for example, that a supply line for supplying the substance to the wound area extends at least partially on or in the suction pump housing, so that the amount of substance passed through this supply line can be determined accordingly by the second measuring device. In a preferred embodiment, however, the second measuring device is arranged at a distance from the suction pump housing. In particular, in this embodiment, a wireless connection between the second measuring device and a control unit arranged in or on the suction pump housing is advantageous. The second measuring device can be arranged in the region of an instillation container, which contains the substance to be supplied, and be designed for measuring the filling level in the instillation container. However, it can also be designed for arrangement within a supply line, which serves for supplying the substance to the human or animal body. In such an embodiment, the determination of the amount supplied by the second measuring device is usually based on a determination of the flow rate.

To determine the amount of substance supplied, the second measuring device Preferably, a dropper, a weight sensor, a capacitive level sensor or a flow meter on.

In a particular embodiment, the suction pump housing has a holder for holding a container with the substance to be supplied. The second measuring device then preferably has a weight sensor attached to the suction pump housing for determining the weight bearing on the holder. In this way, the amount of the supplied substance can be determined very easily. The substance to be supplied may be contained in a liquid bag or in a bottle, which is arranged elevated above the wound area, so that the substance is supplied to the wound area by a supply line due to the hydrostatic pressure. In particular, in such a supply of the substance, the second measuring device may comprise a dropper, which is designed for arrangement within the feed line. The installation of such a device is particularly simple if the second measuring device also has a transmitting unit for wireless communication with a control unit arranged in or on the suction pump housing. In certain embodiments, the device may comprise a peristaltic pump disposed in or on the suction pump housing, which serves for supplying the substance to the human or animal body. That is, the substance is then supplied to the wound bed by means of the peristaltic pump. This allows for better adjustment and control when feeding the substance. In addition, it is then independent of the arrangement and in particular the altitude of the substance filled with the liquid container.

In particular, in the embodiments with a peristaltic pump arranged in or on the suction pump housing or with a peristaltic pump arranged in or on the fluid collecting vessel or with at least one head of a peristaltic pump arranged in or on the fluid collecting vessel, but also in other embodiments, a control unit can be provided which is used to control the Delivery of the substance is formed to the wound bed based on the means of the first Measuring device certain amount of fluid and / or based on the determined by means of the second measuring device amount of the supplied substance. The control can be performed by the control unit, for example based on predefined limits for the amount of fluid aspirated and / or the amount of substance supplied, so that the supply of the substance to the wound bed when exceeding or falling below these limits by those determined by the first and the second measuring device Quantities are adjusted accordingly. However, the control unit is preferably designed to regulate the substance supply based on a comparison or a calculation in the sense of a mathematical combination of the quantities respectively determined by the first and the second measuring device. In this case, the control unit can in particular be designed to determine the difference between the specific quantities of extracted fluids and of supplied substance and to control the suction pump based on this determined difference. In this way, optimal control of the substance supply can be achieved. In particular, if the control unit is also designed to control the fluid suction based on the determined by the first measuring device fluid quantity and / or based on the determined by the second measuring device amount of the supplied substance, an optimal and automated control of wound treatment is possible. If a peristaltic pump is provided which is arranged in or on the suction pump housing or in or on the fluid collecting container, or if the head of a peristaltic pump is arranged on the fluid collecting container and is driven, for example, by a motor arranged in the suction pump housing, the second measuring device can be designed to control the quantity the delivered substance based on the performance of the suction pump and / or to determine based on the pumped by the peristaltic pump for a certain period of time pump energy.

A particularly simple embodiment results when the first measuring device is designed to determine the amount of fluid collected in the fluid collecting container and for this purpose has a capacitive level sensor or a weight sensor.

The mentioned, connectable to the first measuring device and the second measuring device control unit may additionally or alternatively to control the Substitute supply based on the determined by the first measuring device amount of the extracted fluids and / or be formed on the determined by the second measuring device amount of the supplied substance. For this purpose, the control unit may be designed, for example, for regulating the flow rate through a pinch valve or for controlling the delivery rate of a peristaltic pump. The control unit can be connected by means of a cable connection or a wireless connection to the pinch valve or the peristaltic pump. The control is preferably based on a difference, determined by the control unit, between the amount of extracted fluids and the amount of substance supplied.

The invention also relates to a method for healing wound tissue by means of negative pressure treatment of wounds on the human or animal body. In this method, which is preferably but not necessarily carried out by means of the above-mentioned device, on the one hand a substance supplied to a wound bed and on the other hand sucked by means of negative pressure fluids, such as in particular an exudate and the supplied substance from the wound bed. The method has at least the following method steps:

- Sucking the fluids from the wound bed by means of a suction pump;

- supplying the substance to the wound bed;

- Determining the amount of extracted fluids;

- determining the amount of the supplied substance;

- Compare, in particular by means of difference calculation, the amount of extracted fluids with the amount of the supplied substance. The above-mentioned process steps can be performed in any order.

Preferably, the method further comprises the step of controlling the suction of the fluids and / or the supply of the substance based on the comparison, in particular the difference between the amount of the extracted fluids and the amount of the added substance. BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the invention will be described below with reference to the drawings, which are given by way of illustration only and are not to be interpreted as limiting. In the drawings show:

1 is a schematic view of a device according to the invention according to a first embodiment;

FIG. 2 shows a schematic view of a device according to the invention in accordance with a second embodiment; FIG.

3 is a schematic view of a device according to the invention in accordance with a third embodiment;

4 shows a schematic view of a device according to the invention in accordance with a fourth embodiment;

5 shows a schematic view of a device according to the invention in accordance with a fifth embodiment;

6 is a schematic view of a device according to the invention in accordance with a sixth embodiment; such as

Fig. 7 is a typical example of during the operation of a erfmdungsgemässen

Device present curves of the negative pressure, the supplied

Amount of instillation fluid and the amount of extracted fluids.

DESCRIPTION OF PREFERRED EMBODIMENTS

FIGS. 1 to 6 show various embodiments of devices according to the invention for the negative pressure treatment of wounds on the human or animal body.

Elements with an identical or similar technical function and effect are each provided with the same reference numerals in the various embodiments in FIGS. 1 to 6. The devices shown in FIGS. 1 to 6 each have a suction pump housing 2 with a suction pump, not shown in the figures, for sucking off fluids from a wound bed W of a patient P. The wound bed W is covered by a wound cover 1. The wound cover 1 closes off the area of the wound bed W as airtight as possible to the outside.

In the suction pump housing 2, a fluid collection container 3 is mounted in all embodiments shown in Figures 1 to 6, which in principle but also spaced from the suction pump housing 2 and could be connected to this via a connecting line. The fluid collecting container 3 serves to collect the fluids sucked from the wound bed W by the suction pump. The suction of the fluids from the wound bed W takes place, as can be seen, for example, in the first embodiment shown in FIG. 1, through a secretion line 61. The secretion line 61 communicates with a first, patient-side end of the line in fluid-communicating connection with the area of the wound bed W located below the wound cover 1. For this purpose, the secretion line 61 can, for example, be arranged on the wound cover 1, as shown in FIG Drainage connection 10 may be connected. The drainage connection 10 establishes the connection between the wound area and the secretion line 61 and facilitates the connection and removal of the secretion line 61 to or from the wound cover 1. The secretion line 61 opens into the interior of the fluid collection container 3 with a second, suction pump housing-side line end.

In operation, by means of the suction pump in the fluid collection container 3, a negative pressure, ie a pressure lower than atmospheric pressure, is generated in order to suck fluids from the wound bed W via the secretion line 61 and to collect them in the fluid collection container 3. For this purpose, the suction pump, which may in particular be a diaphragm pump, can be connected to the interior of the fluid collection container 3 via a line not shown in the figures. Via an outlet not shown in the figures, the sucked by the suction pump air is expelled into the environment. Parallel to the secretion line 61, an auxiliary line 62 leads from the wound bed W via the fluid collecting container 3 to the pumping unit housing 2. By means of the auxiliary line 62, it is possible to flush the secretion line 61 if necessary and / or to measure the pressure in the secretion line 61. The auxiliary line 61 opens for this purpose preferably in the vicinity of the wound bed W in the secretion line 61, but can also, as shown in Figure 1, via the drainage port 10 directly into the wound bed W open.

In order to supply a substance, such as a physiological or non-physiological saline solution, a drug, an anesthetic or a mixture thereof, to the wound bed W, an instillation line 60 is provided, which opens into the wound bed W with a first end and with a second end the interior of an instillation bag 40 is connected. In this case, the instillation line 60 can, as shown in FIG. 1, be connected to an instillation connection 11 arranged on the wound covering 1 and lead via it into the wound bed W. In particular, the instillation port 11 may facilitate the attachment and removal of the instillation conduit 60 to or from the wound cover 1.

The instillation bag 40 contains an instillation fluid, which is the substance to be delivered to the wound bed W during the vacuum treatment. By means of a hanger the instillation bag 40 is suspended on a suspension hanger 41. In order to utilize the hydrostatic pressure during the supply of the instillation liquid, the instillation bag 40 is arranged with respect to the direction of gravity above the wound bed W. In the embodiment shown in FIG. 1, the suspension bracket 41 is held in the suction pump housing 2. The control of the amount of instill liquid supplied to the wound bed W may be accomplished, for example, by means of a simple pinch valve 50 located within the instillation tubing 60 below the instillation bag 40 or in e.g. the drop counter unit with the drop counter 5, see Figure 2, is arranged.

In the first embodiment according to FIG. 1, the amount of fluid extracted from the wound bed is determined by means of a capacitive fill level sensor 30. By means of the capacitive fill level sensor 30, the fill level in the fluid collection container 3 is determined measured. The capacitive level sensor 30, which thus constitutes a measuring device, is mounted on the inside or outside of the fluid collection container 3 for this purpose. The fill level sensor 30 is connected to a control unit arranged in the suction pump housing 2 and not visible in FIG. 1, so that the fill level values measured by the fill level sensor 30 can be transmitted to the control unit or can be interrogated by the latter.

Another measuring device in the form of a drop counter 5 is arranged below the instillation bag 40 within the instillation line 60. The dropper 5, the possible embodiments of which are well known to those skilled in the art, is used to measure the flow rate of the instillation liquid in the instillation line 60. The dropper 5 is attached to the hanger 41 and via a cable connection 70 to the suction pump housing 2 arranged control unit connected. Through the cable connection 70, the measured values determined by the dropper 5 can be transmitted to the control unit or queried by the latter.

The quantities of fluid measured by the drop counter 5 and the capacitive fill level sensor 30 can now be displayed by means of the control unit, for example, on a display not shown in FIG. The medical staff and / or the patient can thereby inform themselves at any time about the current status of the negative pressure treatment and, for example, completely discontinue or interrupt the treatment or adjust the supply of the instillation fluid and / or adjust the suction power of the suction pump.

However, the quantities of fluid measured by the drop counter 5 and the capacitive fill level sensor 30 are preferably further processed in the control unit, for example by being compared with predetermined limit values. Based on this further processing can be caused by the control unit, for example, an alarm triggering and / or a regulation of the suction power of the suction pump. In the further processing, the control unit preferably forms a difference between the amount of extracted fluids and the amount of instillation fluid supplied. This will make it possible to measure the amount of the body of the body To determine or at least estimate patient P amount of instillation liquid and / or the amount of exudate segregated in the wound bed W. It is thus a very direct and meaningful recording of the course of treatment possible. It is thereby also possible, in the area of the wound cover W, to detect a possible leak or a possible leak (leaking fluid).

The second embodiment shown in Figure 2 differs from the first embodiment of Figure 1 in that on the one hand the level in the fluid collection container 3 by means of a weight sensor 31 is determined, and on the other hand, the connection between the dropper 5 and arranged in the suction pump housing 2 control unit is realized by a wireless connection 71. The weight sensor 31 may be attached to the fluid collecting tank 3 or the suction pump housing 2. The third embodiment shown in FIG. 3 differs from the second embodiment of FIG. 2 in that the determination of the amount of instillation liquid supplied to the wound bed W is effected by means of a weight sensor 21. For this purpose, the suspension bracket 41 is held with its lower end in a holder 20 provided on the suction pump housing 2. By means of the weight sensor 21, the weight bearing on the holder 20 is measured, whereby upon detection of a change in weight on the amount of the wound bed W supplied instillation liquid can be closed. This embodiment is advantageous, in particular, because the installation of the entire device before the treatment is particularly simple for the user.

The fourth embodiment shown in FIG. 4 differs from the first embodiment of FIG. 1 in that, on the one hand, a capacitive fill level sensor 25 for measuring the fill level is provided in the fluid collection container 3, which is attached to the suction pump housing 2, and in that the suspension clip 41 has a base 42 to allow placement of the hanger 41 including instillation bag 40 also away from the suction pump housing 2. In addition, the transmission of the values measured by the dropper 5 to the control unit arranged in the suction pump housing 2 takes place via a wireless connection 71 Level sensor 25 on the suction pump housing 2 has the advantage that the fluid collection container 3, which is usually replaced often and disposed of together with the contents, is cheaper to produce. The embodiment shown in FIG. 4 shows, in particular, that the device according to the invention can be combined very well with a conventional device for supplying the instillation liquid. Only the dropper 5 within the instillation line 60 has to be arranged. Due to the wireless data transmission via the wireless connection 71 no additional cable connections are necessary. The fifth embodiment shown in FIG. 5 differs from the first embodiment of FIG. 1 in particular in that a peristaltic pump 22 is arranged on the suction pump housing 2 in order to convey the instillation fluid present in the instillation line 60 to the wound bed W. For this purpose, the instillation line 60 is inserted into a hose guide 23 provided on the suction pump housing 2 in the region of the peristaltic pump 22. The instillation bag 40 does not necessarily have to be arranged above the wound bed W in this embodiment. In addition, by adjusting the pumping power of the peristaltic pump 22, a very simple and, in particular, automated control of the supply of the instillation fluid is possible. The determination of the amount of instillation liquid supplied through the instillation line 60 can be made simply using, for example, the respective applied pumping power of the peristaltic pump 22.

The sixth embodiment shown in FIG. 6 differs from the fifth embodiment of FIG. 5 in that the instillation container in which the instillation liquid to be supplied is mounted in the form of an instillation can 43 directly and similarly to the fluid collection container 3 on the suction pump housing 2. The determination of the amount of instillation liquid supplied through the instillation line 60 takes place here by means of a flowmeter 24 arranged in or on the suction pump housing 2.

In the figure 7 are typical curves when using a device according to the invention or the inventive method for the prevailing in the wound bed W negative pressure (top graph), for the volume of supplied Instillation fluid (middle graph) and for the volume of sucked from the wound bed W fluids (bottom graph) shown. Of course, the curvatures actually occurring in a wound treatment depend in particular on the size and type of wound.

The curves shown in FIG. 7 show very nicely how the quantities of liquid determined by the first and the second measuring devices (lower two graphics), possibly in combination with a pressure measurement in the region of the wound bed W, for example via the auxiliary line 62 (uppermost graphic), the treatment process and the healing process very directly and directly.

As can be seen from the uppermost graph of FIG. 7, a typical treatment lasts several hours, if not days, so that the wound tissue is given the possibility of a change, in particular of healing. The suction of the fluids from the wound bed W takes place intermittently. After a suction with a period of 1 to 6 hours, a rest phase takes place without negative pressure of one to 30 minutes. Before each rest phase, there is a decay phase during which the negative pressure is steadily reduced. After each resting phase, the negative pressure in a rising phase is in each case continuously increased from atmospheric pressure back to a constantly applied negative pressure. The rise and decay phases last in each case many times less than the respective intermediate suction phase with a constant negative pressure.

The curve shown in the top graph of Figure 7 would actually still an oscillating curve in the negative mmHg range with a relatively short periodicity of a few seconds due to the pumping movements of the suction pump (diaphragm pump) superimposed. For illustrative reasons, this fast oscillating curve is not shown. The illustrated curve depicts the respectively applied amplitude. As can be seen in the middle graph of FIG. 7, the instillation fluid is supplied to the wound bed W only during certain supply phases, which are relatively short in relation to the total time duration of the therapy and are distributed at regular intervals over the entire treatment period. The feeding phases take place together with the decay phases of the extraction. This ensures that, while the instillation liquid is being supplied, there is a reduced, but still a suction, so that no overpressure can occur in the wound bed W. During the subsequent rest phase, the substance supplied to the wound bed can optimally act on the wound tissue.

Finally, it can be seen in the bottom graph of FIG. 7 that the volume of the fluids sucked from the wound bed W increases sharply after each resting phase. Towards the end of the longer periods of constant negative pressure, the amount of aspirated fluids decreases sharply, with the decrease due to the healing process and the consequent reduced amount of exudate removed faster with each treatment cycle. Towards the end of the treatment, only the previously supplied instillation liquid is essentially removed from the wound bed W in each case. Of course, the invention described herein is not limited to the mentioned embodiments and a variety of modifications is possible. Thus, the respective features of the embodiments shown in Figures 1 to 6 in particular can be combined as desired. The curves occurring during the treatment may also differ from those of FIG. 7. Thus, the delivery of the substance, for example, even without interruption and constant throughout the treatment period.

LIST OF REFERENCE NUMBERS

Wound cover hanger

Drainage connection stand

Instillation port Instillationskanister

Suction pump housing 5 dropper

Bracket 50 pinch valve

weight sensor

Peristaltic pump 60 Insti Üationsleitung

Hose guide 61 Secretion line

Flow meter 62 Auxiliary line

Capacitive level sensor

70 cable connection

Fluid collection container 71 wireless connection

Capacitive level sensor

Weight sensor W wound bed

P patient

Instillationsbeutel

Claims

1. Device for healing wound tissue by means of negative pressure treatment of wounds on the human or animal body, in which on the one hand a substance is supplied to a wound bed (W) and on the other hand by means of negative pressure fluids, in particular an exudate and the added substance, from the wound bed (W) be sucked off, having

a suction pump housing (2) having a suction pump disposed therein for sucking the fluids out of the wound bed (W); such as

a fluid collection container (3) for collecting the extracted fluids;

characterized in that

the apparatus comprises a first measuring device (30; 31; 25) for determining the quantity of extracted fluids and a second measuring device (5; 21; 24) for determining the quantity of substance supplied to the body.

2. Device according to claim 1, wherein the device is designed for the intermittent suction of the fluids such that the time intervals during which the suction takes place are many times longer than the time intervals during which no suction takes place.

3. Device according to claim 2, wherein the intermittent suction has a periodicity which is tuned to the periodicity of the likewise intermittent supply of the substance.

4. Device according to one of the preceding claims, further comprising a control unit which can be connected to the first measuring device (30; 31; 25) and the second measuring device (5; 21; 24) and which is used to control the suction pump on the basis of that of the first measuring device ( 30, 31, 25) of the quantity of extracted fluid and / or on the quantity determined by the second measuring device (5, 21, 24) of the supplied substance.

5. Device according to one of the preceding claims 1 to 3, in addition comprising a control unit which can be connected to the first measuring device (30; 31; 25) and the second measuring device (5; 21; 24) and which is designed to determine a difference between the quantity of the extracted fluids and the quantity of the substance supplied.

6. Apparatus according to claim 5, wherein the control unit for controlling the suction pump is formed based on this specific difference.

7. Device according to one of claims 4 to 6, wherein the control unit within or on the suction pump housing (2) and the second measuring device (5) spaced from the suction pump housing (2) is arranged.

8. Apparatus according to claim 7, wherein the second measuring device (5) by means of a cable or wireless connection (70, 71) is connectable to the control unit.

9. Device according to one of claims 4 to 6, wherein both the control unit and the second measuring device (21; 24) is disposed within or on the suction pump housing.

10. Device according to one of the preceding claims, wherein the second measuring device comprises a dropper (5), a weight sensor (21), a capacitive level sensor or a flow meter (24).

1 1. Device according to one of the preceding claims, wherein the suction pump housing (2) has a holder (20) for holding a container (40) with the substance to be supplied, and wherein the second measuring device on the suction pump housing (2) mounted weight sensor (21) for determining the weight bearing on the holder (20).

12. Device according to one of the preceding claims, further comprising a in or on the suction pump housing (2) arranged peristaltic pump (22) or in or on the fluid collection container (3) arranged head of a peristaltic pump, which for supplying the substance to the human or animal body serves.

13. The apparatus of claim 12, wherein the second measuring means is adapted to determine the amount of the supplied substance based on the power of the suction pump and / or based on the pumping energy provided by the peristaltic pump for a certain period of time.

14. Device according to one of the preceding claims, wherein the first measuring device for determining the amount of fluid in the fluid collecting container (3) is formed and for this purpose a capacitive level sensor (30; 25) or a weight sensor (31).

15. Device according to one of the preceding claims, further comprising a control unit which can be connected to the first measuring device (30; 31; 25) and the second measuring device (5; 21; 24) and which is used to control the substance feed on the basis of that of the first measuring device ( 30, 31, 25) of the quantity of extracted fluid and / or on the quantity determined by the second measuring device (5, 21, 24) of the supplied substance.

16. A method for healing wound tissue by means of negative pressure treatment of wounds on the human or animal body, in which on the one hand a substance is supplied to a wound bed (W) and on the other hand by means of negative pressure fluids, in particular an exudate and the added substance, from the wound bed (W) be exhausted, comprising at least the following process steps:

- Sucking the fluids from the wound bed (W) by means of a suction pump;

- supplying the substance to the wound bed (W);

- Determining the amount of extracted fluids;

- determining the amount of the supplied substance;

- Compare, in particular by means of difference calculation, the amount of extracted fluids with the amount of the supplied substance.

17. The method of claim 16, wherein the suction of the fluids and / or the supply of the substance is controlled based on the comparison between the amount of the extracted fluids and the amount of the supplied substance.