EP3568169A1 - Dispositif ainsi que procédé pour le traitement de plaies par pression négative et apport d'une substance - Google Patents

Dispositif ainsi que procédé pour le traitement de plaies par pression négative et apport d'une substance

Info

Publication number
EP3568169A1
EP3568169A1 EP18700540.0A EP18700540A EP3568169A1 EP 3568169 A1 EP3568169 A1 EP 3568169A1 EP 18700540 A EP18700540 A EP 18700540A EP 3568169 A1 EP3568169 A1 EP 3568169A1
Authority
EP
European Patent Office
Prior art keywords
substance
measuring device
supplied
suction pump
fluids
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP18700540.0A
Other languages
German (de)
English (en)
Inventor
Martin Walti
Tobias HÄNGGI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medela Holding AG
Original Assignee
Medela Holding AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medela Holding AG filed Critical Medela Holding AG
Publication of EP3568169A1 publication Critical patent/EP3568169A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0204—Physical characteristics of the irrigation fluid, e.g. conductivity or turbidity
    • A61M3/022—Volume; Flow rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71—Suction drainage systems
    • A61M1/74—Suction control
    • A61M1/75—Intermittent or pulsating suction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71—Suction drainage systems
    • A61M1/77—Suction-irrigation systems
    • A61M1/777—Determination of loss or gain of body fluids due to suction-irrigation, e.g. during surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/84—Drainage tubes; Aspiration tips
    • A61M1/85—Drainage tubes; Aspiration tips with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/92—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing with liquid supply means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/96—Suction control thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/98—Containers specifically adapted for negative pressure wound therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/98—Containers specifically adapted for negative pressure wound therapy
    • A61M1/982—Containers specifically adapted for negative pressure wound therapy with means for detecting level of collected exudate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/15—Detection of leaks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3317—Electromagnetic, inductive or dielectric measuring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3379—Masses, volumes, levels of fluids in reservoirs, flow rates
    • A61M2205/3389—Continuous level detection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3379—Masses, volumes, levels of fluids in reservoirs, flow rates
    • A61M2205/3393—Masses, volumes, levels of fluids in reservoirs, flow rates by weighing the reservoir

Definitions

  • 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.
  • the invention relates to a corresponding method for the negative pressure treatment of wounds on the human or animal body.
  • 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).
  • NPWT Negative-Pressure Wound Therapy
  • body fluids or secretions are sucked out of the wound bed by means of a pump.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • a device is proposed, as indicated in claim 1.
  • 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.
  • the wound bed is thus supplied with a substance.
  • 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.
  • the fluids may also include at least a portion of the substance supplied to the wound bed.
  • 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.
  • 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.
  • 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.
  • an additional pressure measurement can be carried out especially in the wound area in order to further optimize the monitoring and control.
  • 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.
  • the determination of the fluid or substance quantities can also only serve to prevent overpressure in the wound area.
  • 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.
  • the instillation substance can optionally be preconditioned, for example, with a defined temperature, UV radiation and / or a specific chemical composition or mixture.
  • 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.
  • 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.
  • a membrane pump has at least one membrane and a pump chamber which is limited by this.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 .
  • 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.
  • 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.
  • 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.
  • 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.
  • the second measuring device is arranged at a distance from the suction pump housing.
  • 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.
  • the second measuring device Preferably, a dropper, a weight sensor, a capacitive level sensor or a flow meter on.
  • 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.
  • the second measuring device may comprise a dropper, which is designed for arrangement within the feed line.
  • the second measuring device also has a transmitting unit for wireless communication with a control unit arranged in or on the suction pump housing.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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:
  • 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.
  • FIG. 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
  • FIG. 4 shows a schematic view of a device according to the invention in accordance with a fourth embodiment
  • FIG. 5 shows a schematic view of a device according to the invention in accordance with a fifth embodiment
  • FIG. 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
  • 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.
  • 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.
  • 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.
  • 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.
  • a negative pressure ie a pressure lower than atmospheric pressure
  • 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.
  • an auxiliary line 62 leads from the wound bed W via the fluid collecting container 3 to the pumping unit housing 2.
  • auxiliary line 62 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.
  • an instillation line 60 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.
  • 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.
  • 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.
  • an instillation fluid which is the substance to be delivered to the wound bed W during the vacuum treatment.
  • the instillation bag 40 is suspended on a suspension hanger 41.
  • the instillation bag 40 is arranged with respect to the direction of gravity above the wound bed W.
  • 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.
  • the amount of fluid extracted from the wound bed is determined by means of a capacitive fill level sensor 30.
  • the 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.
  • 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.
  • 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.
  • the suspension bracket 41 is held with its lower end in a holder 20 provided on the suction pump housing 2.
  • 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.
  • 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 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.
  • 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.
  • 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.
  • FIG 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.
  • top graph the volume of supplied Instillation fluid
  • bottom graph the volume of sucked from the wound bed W fluids
  • 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.
  • 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.
  • 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.
  • Fluid collection container 71 wireless connection

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Vascular Medicine (AREA)
  • Pulmonology (AREA)
  • Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • External Artificial Organs (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un dispositif pour le traitement par pression négative de plaies sur un organisme humain ou animal, avec lequel, d'une part, une substance est apportée dans un lit de plaie (W) et, d'autre part, des fluides, tels qu'en particulier un exsudat et la substance appliquée, sont aspirés du lit de plaie (W) par pression négative. Le dispositif comprend un boîtier de pompe aspirante (2) dans lequel est disposée une pompe aspirante pour l'aspiration des fluides du lit de plaie (W), ainsi qu'un réservoir de collecte de fluide (3) pour recueillir les fluides aspirés. Le dispositif comprend en outre un premier dispositif de mesure (30 ; 31 ; 25) ainsi qu'un deuxième dispositif de mesure (5 ; 21 ; 24). Le premier dispositif de mesure (30 ; 31 ; 25) sert à déterminer la quantité de fluides aspirés et le deuxième dispositif de mesure (5 ; 21 ; 24) à déterminer la quantité de substance apportée à l'organisme.
EP18700540.0A 2017-01-10 2018-01-05 Dispositif ainsi que procédé pour le traitement de plaies par pression négative et apport d'une substance Withdrawn EP3568169A1 (fr)

Applications Claiming Priority (2)

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EP17150814 2017-01-10
PCT/EP2018/050275 WO2018130466A1 (fr) 2017-01-10 2018-01-05 Dispositif ainsi que procédé pour le traitement de plaies par pression négative et apport d'une substance

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EP3568169A1 true EP3568169A1 (fr) 2019-11-20

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EP (1) EP3568169A1 (fr)
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WO2019157466A1 (fr) 2018-02-12 2019-08-15 Healyx Labs, Inc. Systèmes, dispositifs et méthodes de traitement de plaie par pression négative
US11253401B2 (en) * 2018-08-03 2022-02-22 Kci Licensing, Inc. Wound therapy system with wound volume estimation
CN109381764B (zh) * 2018-10-12 2020-12-25 王京涛 一种普外科防积液式创口冲洗器
JP2022519365A (ja) * 2019-02-06 2022-03-23 ケーシーアイ ライセンシング インコーポレイテッド 内部交互オリフィスを有する創傷療法システム
US11471573B2 (en) * 2019-03-27 2022-10-18 Kci Licensing, Inc. Wound therapy system with wound volume estimation
EP3946492A1 (fr) * 2019-03-27 2022-02-09 KCI Licensing, Inc. Système de traitement de plaie permettant une estimation du volume de la plaie
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US11554205B2 (en) 2023-01-17
CA3046127A1 (fr) 2018-07-19
WO2018130466A1 (fr) 2018-07-19
US20190365961A1 (en) 2019-12-05

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