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WO2016079075A1 - Détecteur électronique de fluides pour dispositif de thérapie par pression négative (tpn) - Google Patents

Détecteur électronique de fluides pour dispositif de thérapie par pression négative (tpn) Download PDF

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Publication number
WO2016079075A1
WO2016079075A1 PCT/EP2015/076736 EP2015076736W WO2016079075A1 WO 2016079075 A1 WO2016079075 A1 WO 2016079075A1 EP 2015076736 W EP2015076736 W EP 2015076736W WO 2016079075 A1 WO2016079075 A1 WO 2016079075A1
Authority
WO
WIPO (PCT)
Prior art keywords
liquid
sensor
pump
filter
negative pressure
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.)
Ceased
Application number
PCT/EP2015/076736
Other languages
German (de)
English (en)
Inventor
Pierre Croizat
Martin Deibler
Chris Dawber
James Edward STEIN
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.)
Paul Hartmann AG
Original Assignee
Paul Hartmann 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 Paul Hartmann AG filed Critical Paul Hartmann AG
Publication of WO2016079075A1 publication Critical patent/WO2016079075A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • 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
    • A61M1/78—Means for preventing overflow or contamination of the pumping systems
    • A61M1/784—Means for preventing overflow or contamination of the pumping systems by filtering, sterilising or disinfecting the exhaust air, e.g. swellable filter valves
    • 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
    • A61M1/60—Containers for suction drainage, adapted to be used with an external suction source
    • 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
    • A61M1/984—Containers specifically adapted for negative pressure wound therapy portable on the body
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/11—General characteristics of the apparatus with means for preventing cross-contamination when used for multiple patients
    • 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
    • A61M2205/16—General characteristics of the apparatus with back-up system in case of failure
    • 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
    • A61M2205/3306—Optical 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
    • A61M2205/3317—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
    • A61M2205/75—General characteristics of the apparatus with filters
    • A61M2205/7536—General characteristics of the apparatus with filters allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes
    • 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
    • A61M2209/00—Ancillary equipment
    • A61M2209/08—Supports for equipment
    • A61M2209/088—Supports for equipment on the body

Definitions

  • the invention relates to devices and methods for providing negative pressure for medical applications, in particular devices for negative pressure therapy of wounds on the human or animal body and their use.
  • Devices include a pump, a port for a suction line, a vacuum connection, a filter, a control unit and an electronic fluid sensor.
  • Vacuum therapy of wounds also referred to in the field as TNP (topical negative pressure) or NPWT (negative pressure wound therapy)
  • TNP topical negative pressure
  • NPWT negative pressure wound therapy
  • a wound filling material is usually inserted into the wound, the wound area covered with a foil and by means of a
  • Drainage tube and a vacuum pump generates a negative pressure in the wound space.
  • the pressure is evenly distributed over the wound.
  • the negative pressure causes, especially in the initial phase of wound treatment, an effective wound cleansing by removing wound exudate.
  • Wound closure performed. Wound closure is generally considered to be achieved when there is a layer of epidermis over the former wound site. Wound closure can be achieved through healing processes or through surgical procedures. Negative pressure therapy is used in particular in acute or chronic wounds, for example in ulcers (eg pressure sores, diabetic, neuropathic or venous ulcers), traumatic wounds, therapy-resistant wounds, infected wounds, postoperative wounds, probed fistulas, as well as
  • a conventional device for negative pressure therapy of wounds usually comprises a suction pump (also referred to in the art as “vacuum source”), one or more sensors for pressure monitoring, a control unit for
  • Control of the pump including a data memory, user controls (eg, switches, indicator lights or display), terminals for data communication, a power supply for the pump and the control unit (for example, an accumulator and / or a power supply), a fluid receptacle for Intake of body fluids extracted from a wound, a port for one or more wound suction lines, filters to prevent ingestion of body fluids into the pump, and vacuum connections by means of which fluid communication between the individual components can be established.
  • user controls eg, switches, indicator lights or display
  • terminals for data communication for example, a power supply for the pump and the control unit (for example, an accumulator and / or a power supply), a fluid receptacle for Intake of body fluids extracted from a wound, a port for one or more wound suction lines, filters to prevent ingestion of body fluids into the pump, and vacuum connections by means of which fluid communication between the individual components can be established.
  • WO2012022484 WO201 1072840, WO2012167942 or WO201 1003521 known wound dressings are introduced.
  • a wound dressing made of an open-celled polyester polyurethane foam which is described in more detail in WO2012022485, has proven to be particularly advantageous in vacuum wound treatment.
  • Devices for negative pressure therapy of wounds are commercially available. The range of devices available on the market includes small, portable devices that allow patients a degree of mobility through to stationary devices, such as long-term care facilities.
  • devices are available, as described for example in WO201 1018132 or WO201 1018133, which are suitable for both stationary and mobile operation.
  • Vacuum therapy suitable accessories such as wound dressings, other dressing components or connecting means is also commercially available.
  • Liquids for example, water, rinsing liquids or body fluids
  • gases for example, air or water vapor
  • Lines in particular body fluids
  • gases in particular air
  • Liquid may also be present in the form of very fine droplets in the air sucked towards the device.
  • the air can contain a high proportion of water vapor (humid air).
  • the negative pressure treatment body fluids are sucked out of the wound area.
  • This may in particular be blood, wound exudate
  • Rinsing fluid accumulates, for example, in the so-called instillation therapy. This is in the
  • Negative pressure typically incurred fluid volumes depend on the particular treatment method used and can be considerable
  • Liquid receiving container for receiving extracted from a wound body fluids provided. For reasons of hygiene, these are usually containers which are disposed of after a single use
  • Wound exudate is then stored in such devices usually in the wound dressing, the dressing having liquid-absorbing components, see, for example, WO2009066105.
  • Body fluids may enter the vacuum source, particularly if the fluid receptacle or other device used to collect the aspirated fluids, such as an absorbent bandage, is full or saturated and the vacuum source is not timely turned off. Furthermore, liquids in the form of small droplets can be entrained by the air flow and thus penetrate into the vacuum source.
  • the commercially available devices also referred to herein as negative pressure therapy unit, therefore usually contain a filter in the vacuum line, which is to prevent the ingress of liquid into the pump.
  • the filter is usually located between the receptacle and the inlet of the pump.
  • the filter which is usually a microfilter, is securely connected to the container and is disposed of when the container is replaced.
  • the filter is usually in the dressing component, see the aforementioned WO2009066105.
  • the nature of the filter is such that air can pass but liquid is retained.
  • common negative pressure therapy devices often have a mechanism which ensures that the device is turned off when the container (if any) is full.
  • the above-mentioned filters optionally supplemented by a shut-off mechanism with a full container, prevent the entry of liquid into the pump.
  • Negative pressure operation occur.
  • an initially intact filter initially restrains the incoming liquid.
  • the liquid retained by the filter moistens the filter. If the humidified filter is then exposed to sustained negative pressure for a prolonged period of time, for example if the shut-off mechanism malfunctions, the filter can "break through" so that liquid can enter the line leading to the pump.
  • the objects have been achieved by means of a user-portable and / or stationary device for providing negative pressure for the negative-pressure therapy of wounds on the human or animal body.
  • the device comprises a (in operation of the device) generating the negative pressure electrically driven
  • the or electrically driven pump having an inlet for sucking in air, with an outlet for blowing out air and with an interior which can communicate with inlet and outlet, a connection for a suction line leading to the wound site, a vacuum connection between the connection and the inlet, so that a vacuum communication between the pump and the leading to the wound site suction line can be produced, at least one filter which is impermeable to liquids in the intact state, wherein the filter in the
  • Vacuum connection is arranged, as well as an electronic control unit for the pump.
  • the device according to the invention is characterized in that the Device further comprises at least one electronic liquid sensor, which can communicate with the control unit, wherein the at least one liquid sensor is arranged downstream of the filter.
  • downstream is in this case based on the fluid flow, which is moved in the intended use of the device in the negative pressure therapy, starting from the wound in the direction of the pump and on to the pump outlet.
  • Liquid sensors can improve the operational safety and service life of a
  • Immediately downstream of the filter is normally the section between the filter and the inlet of the pump.
  • the section between the filter and the inlet of the pump is usually formed by a conduit means, for example by a silicone tube. It would also be possible in principle to attach the filter directly to the inlet of the pump. In that case there will be no conduit between the filter and the inlet of the pump.
  • the pump Farther downstream is the pump, which can move the fluid flow during operation.
  • the pump includes an inlet for sucking in air, a
  • the interior through which the fluid flow is moved through and an outlet for blowing out the fluids.
  • the interior can mutually communicate with both the inlet and the outlet when the pump is actuated.
  • the outlet can open into an opening so that the fluids are released directly into the atmosphere.
  • further fluid flow conductive components may be present downstream of the outlet.
  • the "outlet portion of the pump", as used herein, includes conduit means downstream of the outlet of the pump or other cavities, the downstream opening of which then discharges into the atmosphere.
  • the area of the outlet often comprises noise attenuation elements and / or in practice
  • the suction line leading to the wound site can be connected to a vacuum dressing, which usually comprises at least one wound dressing and an airtight cover (typically a self-adhesive film), the cover being adhesively fixed to the intact skin surrounding the wound.
  • the wound dressing is often an open-cell foam, for example the polyester polyurethane foam described in the aforementioned WO2012022485, which can optionally be applied in conjunction with an additional wound contact layer.
  • the vacuum communication between the suction line and the wound dressing is normally made by a vacuum connection means (port).
  • the dressing components referred to herein are commercially available, for example under the name of Hydro film ® (air-tight covering), "VivanoMed ® Foam” (polyester-polyurethane), “VivanoMed ® Silicone Layer” (wound contact layer), and “VivanoTec ® Port” (vacuum connection means) , each from the manufacturer Paul Hartmann AG (Germany).
  • the vacuum generating electrically driven or electrically driven pump is often a diaphragm pump, which is controlled and controlled by the electronic control unit.
  • the electronic control unit is preferably a programmable control unit which can communicate with an external electronic device via an interface, for example a USB interface.
  • an interface for example a USB interface.
  • the control unit can be programmed and / or stored on the control unit as part of a maintenance
  • the electronic control unit preferably comprises operating elements, for example a touchscreen, by means of which a user can control the
  • Activating or deactivating the negative-pressure therapy device and the parameters desired for the therapy procedure can enter.
  • a negative pressure therapy unit with an electrically driven pump, with electronic control unit and with touchscreen is commercially available, for example, under the name "VivanoTec ® negative pressure unit” from the manufacturer Paul Hartmann AG (Germany).
  • the vacuum connection between the inlet of the pump and the connection for the suction line makes it possible to establish a vacuum communication between the pump and the suction line.
  • the vacuum connection is normally one or more interconnected conduit sections made of plastic.
  • the vacuum connection and / or the wound suction line should be of suitable length so that the device can be provided spaced from the wound site. Insofar as the device has an optional existing liquid receptacle, the receptacle interior can also form a part of the vacuum connection when the receptacle is arranged between the pump and the connection.
  • a filter is arranged, which is permeable to the sucked air in the dry state and at the same time blocks the passage of liquid to - at least in the intact state - the ingress of liquid in
  • filters examples include membrane filters (for example made of cellulose layers) or filters made of a porous solid (for example a ceramic material, a plastic material, a metal or a sintered body).
  • a porous solid for example a ceramic material, a plastic material, a metal or a sintered body.
  • one or more additional swellable components may advantageously be present (for example carboxymethyl cellulose), which block the passage of fluid as soon as the filter is soaked through.
  • At least one electronic one is downstream of the filter
  • the at least one electronic liquid sensor can accordingly
  • At least one electronic fluid sensor is disposed in the section between the filter and the inlet of the pump (section i) and / or in the region of the outlet of the pump (section iv).
  • the at least one electronic fluid sensor may be downstream of the filter
  • Sections of the fluid system present downstream of the filter can occur in practice, in particular in the case of a defective filter.
  • the electronic fluid sensor is thus provided in particular for the detection of fluid, which has undesirably penetrated through a defective filter in the downstream of the filter existing portions of the fluid system.
  • the device comprises an electronic liquid sensor, which is arranged between the filter and the inlet, as a result
  • Liquid entry can already be detected before the liquid has penetrated into the pump.
  • the pump already immediately after
  • the invention thus also includes a device of the type described herein, wherein the electronic control unit can deactivate the pump immediately after a detection of liquid in the present between the filter and the inlet portion of the vacuum connection. In particular, this can prevent liquid from being sucked through the pump and via the outlet from the closed fluid system
  • Liquid sensor an audible and / or visual warning signal to alert the user to the ingress of liquid in the downstream of the filter section of the fluid system.
  • a sensor signal for immediate shutdown of the pump and for outputting a warning signal (visually and / or acoustically). At the same time, the event becomes electronic
  • Control unit belonging to electronic memory an additional message via a remote data communication could be issued if the device has a corresponding communication device. It would then be possible, among other things, to alert the medical care staff and / or a service center of the device manufacturer to the defective filter.
  • a sensor signal leads to the immediate switching off of the pump, to the issuing of a warning signal and to the blocking of the negative pressure therapy unit for the user.
  • the blockage of the negative pressure therapy unit can only be canceled by a service technician of the device manufacturer, but not by the user. This is a security measure, which should ensure that a possibly with
  • Wound-secreted contaminated device is no longer used and instead checked expertly.
  • the response of the electronic liquid sensor in an electronic memory belonging to the electronic control unit be held.
  • the response of the sensor and, where appropriate, the intensity or the course of the sensor signals, the time of the event or the events should be registered.
  • the stored information for the response of the sensor can then be retrieved, for example in the course of maintenance of the device. The maintenance technician thus receives instructions in the
  • the invention therefore includes the use of a liquid sensor in a negative pressure therapy device of the present invention
  • the invention also contemplates the use of the liquid sensor to protect the pump, the device, and the environment
  • the invention comprises a maintenance method for the detection of
  • the maintenance procedure includes the following steps:
  • Points of the fluid system point must therefore be assumed that a liquid inlet into the pump. Portions of the vacuum connection disposed downstream of the filter also indicate that the filter has malfunctioned in one or more of the previous uses of the devices. Furthermore, there is a risk of damage to the pump by the liquid penetrated. In the worst case can
  • Body fluids have been sucked through filters and through the pump and blown out into the housing of the device or into the environment.
  • Control unit are stored so that they can be accessed during maintenance.
  • sensor signals that indicate the ingress of a larger amount of liquid could lead to an immediate shutdown of the pump and, if necessary, to a blockage of the device for the user.
  • the stored messages could be made available via remote data communication, for example in connection with remote maintenance of the device by a service center of the device manufacturer.
  • the present invention comprises the use of a liquid sensor, in particular an optoelectronic liquid sensor, in a device of the type described herein for detecting liquid entry in downstream of the filter disposed portions of the fluid system.
  • the invention preferably comprises the use of a liquid sensor, in particular of an optoelectronic liquid sensor, for safety shutdown of the pump and / or for alerting a user and / or for storing the event in an electronic memory belonging to the electronic control unit.
  • the liquid sensor with the control unit is a liquid sensor with the control unit
  • the communication is preferably carried out by a direct electrical connection.
  • the communication can also be realized by a different type of connection, for example by an optical connection (fiber optic) or wirelessly by radio link.
  • the device preferably comprises a fluid receptacle for receiving aspirated from the wound
  • the liquid receiving container is arranged in the vacuum connection between the filter and the connection for the suction line leading to the wound site.
  • the container then has at least one inlet for feeding the body fluids and at least one outlet for
  • the liquid receiving container serves to receive and store the liquids sucked from the wound site on the patient, for example wound exudate and / or rinsing liquid.
  • the fluid receptacle is usually a disposable article which is discarded after the vacuum therapy.
  • the manufacturer provides liquid receiving containers with different capacities. Smaller containers, for example with a capacity of 100 ml to 400 ml, could be provided for the mobile operation of the device, while larger containers, for example with a capacity of 400 ml to 2000 ml, then be used for a stationary operation.
  • connection for the suction line leading to the wound site be attached.
  • a conduit means is present, at its pointing to the patient's body end then the connection for the suction line is attached.
  • the aforesaid conduit forms part of the vacuum connection between the port and the inlet of the pump. The vacuum connection is then placed over the interior of the container and the
  • Tank outlet over the filter up to the inlet of the pump.
  • the filter can be located directly in the area of the container outlet, which to
  • the filter may be firmly and permanently attached to the container. It would also be possible to connect the filter with the container outlet via a conduit means.
  • the device according to the invention can be used particularly advantageously in particular if the aspirated liquids are stored in the receptacle in liquid form until disposal.
  • Thickening agents also referred to as “trapping agents” are present.
  • the aspirated liquids are not stored in thickened form until disposal.
  • the liquid receiving container has in its interior by ribs or projections formed areas or mutually communicating chambers, so that the body fluids collected in the interior of the container are prevented in a movement of the container in the uncontrolled slosh. It has proved to be particularly advantageous when the device is a first
  • Housing part with a negative pressure generating means (pump) and a second housing part, which forms the liquid receiving container and which is manually attachable to the first housing part of the device and manually detachable from the first housing part of the device comprises.
  • Therapy device which forms the first housing part, both for mobile operation and for stationary operation, for example in the hospital, can be used.
  • the first housing part should in addition to the pump, inter alia, the
  • Control unit the liquid sensor and possibly a power supply to be accommodated.
  • power supply used to operate electrical or electronic components (eg pump, fluid sensor,
  • Control unit or controls is required, it may in particular be a power supply and / or a battery. Furthermore, at the first
  • Housing part controls for the device (means for operating the control unit by a user), in particular a touch screen display, be present.
  • the second housing part preferably comprises the intended for single use components of the therapy device, namely the liquid receptacle and either the connection for the suction line, which is located directly on the container or a line leading to the connection including the connection.
  • the second housing part preferably comprises the filter so that it can be disposed of together with the container.
  • the filter is arranged directly at the outlet of the liquid receiving container.
  • the electronic fluid sensor is a sensor suitable for detecting fluid.
  • the sensor must be suitable for detecting liquid present in a closed interior.
  • Sensor types for the detection of liquid include, for example, sensors which are based on the measurement of light (optoelectronic sensors), sensors which are based on the measurement of the electrical capacitance (capacitive sensors) or sensors which detect liquid due to a change in the electrical conductivity (conductive sensors ) can prove.
  • sensors which are based on the measurement of light optical sensors
  • sensors which are based on the measurement of the electrical capacitance capacitance sensors
  • sensors which detect liquid due to a change in the electrical conductivity conductive sensors
  • optoelectronic liquid sensor used as an optoelectronic
  • Liquid sensor has a suitable sensitivity and very fast (in
  • Millisecond range is responsive to the presence of liquid or liquid droplets in the measurement path.
  • the presence of liquid in the tube is detectable by a change in the optical density (transmission) or by a change in the refraction of the light.
  • Photocells that register a change in transmission are commercially available and very cost effective.
  • the fluids to be detected are, in particular, body fluids, rinsing fluids or mixtures thereof.
  • Body fluids are usually colored and can easily be detected by a light barrier.
  • the rinsing liquids used, for example, for instillation therapy are clear liquids (saline solutions) which less dampen the transmission.
  • the measurement should therefore take place at a wavelength which is sufficiently absorbed by an aqueous solution, For example, in the UV range at less than 240 nm or in the long-wavelength range at more than 600 nm.
  • Liquid sensor may be housed in a darkened area of the device, since the detection of liquid in the hose could otherwise be disturbed by ambient light.
  • the darkening can be done by a housing in which the
  • Liquid sensor and the other electronic components of the device are housed.
  • Commercially available liquid sensors comprising a light source and a phototransistor are suitable for practical use.
  • As the light source an LED lamp is usually used.
  • the light source and the phototransistor are with a hose holder to a sensor assembly
  • the assembly may include a calibration module for manufacturing-related
  • the sensor assembly may be mounted on a circuit board, for example on the board, which also carries the control unit.
  • a circuit board for example on the board, which also carries the control unit.
  • Invention suitable electronic liquid sensor with LED, phototransistor and hose holder is available, for example, under the name OPB350 from OPTEK Technology Inc. (USA). Based on the electrical signals output by the liquid sensor ("sensor output"), it is possible to differentiate the states “no liquid present” and “liquid present.” Threshold values of the sensor output serve to delimit the different states, their exceeding or undershooting by the control unit Presence or absence of liquid in the relevant section of the fluid system are interpreted.
  • the present invention therefore includes a method of detecting liquid intrusion downstream of the filter disposed portions of the fluid system, wherein the present on the optoelectronic sensor temporal change of the sensor output by the electronic control unit is then evaluated as liquid penetration, if a rapid increase or a rapid drop in sensor output (measured as voltage or current) occurs.
  • a change in the voltage applied to the sensor or the current flowing through the sensor by more than 10% per minute, preferably more than 10% per 1 second, more preferably more than 10% per 0 , 1 second, in particular by more than 10% per 10 milliseconds, understood.
  • the evaluation of the time available on the optoelectronic sensor change of the sensor output allows a very fast and sensitive detection of liquid entry into the respective sections of the fluid system. A quick detection of the
  • a suitable threshold value for the state "fluid present" are determined.
  • the threshold which is indicated for example in the unit volts per second (V / s), then serves to detect the liquid entry, so that, for example, issued an alarm message and the pump is deactivated.
  • Threshold is first determined the fluctuation of the sensor output. This is preferably done when the measuring area (for example a tube section) is dry is.
  • the standard deviation ⁇ of the sensor signals is determined from the measured values.
  • the threshold value for the rate of change (d (sensor output) / dt) is then obtained by multiplying the determined standard deviation ⁇ by a suitable multiplication factor. It has been shown that the multiplication factor should be between 5 and 20 in order to ensure sensitive and error-free detection. Preferably, the factor is 10 to 15, in particular 12 to 13.
  • the detection method described here allows the very fast (in the millisecond range) detection of very small amounts of liquid (in the ⁇ range), even if the liquid is in the form of very fine droplets.
  • the device comprises an optoelectronic liquid sensor, which can detect a change in the transmission and / or refraction due to a liquid.
  • the sensor is arranged in that section of the vacuum connection which is located between the filter and the inlet of the pump, the section being formed by a transparent hose, in particular by a silicone hose.
  • the senor is mounted on the outside of the transparent tube, so that the presence of liquid in the tube causes a detectable by the sensor change in the transmission and / or refraction.
  • the electronic control unit evaluates the sensor signals (sensor output) as ingress of liquid into the relevant section of the vacuum connection when a preset threshold for the time change of the
  • the threshold value in this case is 3 times to 30 times, in particular 5 times to 20 times, particularly preferably 10 times to 15 times, very particularly preferably 12 times to 13 times the standard deviation ⁇ , where the standard deviation ⁇ is determined on the basis of at least 5 consecutive measurements of the sensor output of a sensor applied to a dry hose.
  • Sensor signals are preferably those on the
  • a suitable detection method may optionally also be simultaneous
  • Evaluation of both threshold values and temporal change rates of the sensor output include: Accordingly, the control unit interprets the
  • Sensor output then as liquid entering the vacuum connection when either absolute thresholds of the sensor output are exceeded or fallen below or when the rate of change exceeds a preset value.
  • the present invention further relates to a method for negative pressure therapy of
  • Wounds comprising the steps:
  • the apparatus described herein may additionally include a liquid indicator for indicating and / or detecting liquid which has entered portions of the fluid system disposed downstream of the filter.
  • a liquid indicator is understood as meaning a substance which exhibits a color change or a color change after the liquid has been absorbed. The color change can also be a change in color intensity.
  • the indicator substance is normally applied to a carrier. It would also be possible to apply the substance directly to components of the vacuum connection, for example to the inside of a conduit means.
  • Liquid indicator in which the penetration of liquid is already visible to the naked eye, can be provided as an additional security measure. It is also conceivable to detect the color change or the color change likewise electronically. This can be done by means of the liquid sensor already present in the device according to the invention or by means of an additional optoelectronic sensor. Furthermore, it may prove advantageous to have an additional security measure.
  • Fluid indicator which is provided inside the housing of the device, but outside the fluid system to provide. Such an indicator can give the maintenance personnel an indication that the device undesirable with
  • Liquid has come into contact. Such liquid indicators are known from the prior art and are used regularly, for example, in mobile phones.
  • Figure 1 shows a simply configured embodiment of the device according to the invention.
  • FIG. 2 shows another embodiment of the present invention.
  • FIG. 3 shows an embodiment of the device according to the invention comprising a first housing part and a second housing part.
  • Figure 4 shows a suitable for use in the device according to the invention
  • FIG. 5 a shows the sensor output (in V) determined during a test as a function of the presence or absence of water in a plastic tube.
  • FIG. 5 b shows the time change rate of the sensor output (in V / s) determined during an experiment.
  • FIG. 6 shows a warning message which can be output after the detection of liquid.
  • FIG. 1 shows a schematic representation of a device 10 according to the invention for providing negative pressure.
  • the device comprises an electronic
  • Control unit 7 and an electrically driven or electrically driven pump 1 with an inlet 2 for sucking in air and an outlet 3 for blowing out air. Furthermore, the device comprises a connection 4, a filter 6, a liquid sensor 8 and a vacuum connection 5
  • Liquid sensor 8 communicates via the connection 12 with the control unit 7.
  • connection 1 1 and / or the connection 12 may be a
  • a negative pressure communication between the wound site (not shown in FIG. 1) and pump 1 can be established via port 4.
  • the connection 4 is For example, a conventional quick disconnect connector for plastic tubing.
  • a suction line 18 is connected via the connection 4 with the vacuum connection 5.
  • the vacuum connection 5, which allows a negative pressure communication between the inlet 2 of the pump and the port 4, consists in the embodiment shown in Figure 1 of three sections, namely the portion between terminal 4 and the filter 6, the portion between the filter 6 and liquid sensor eighth and the section between liquid sensor 8 and pump 1.
  • the device according to the invention may comprise further sections, as shown for example in FIG.
  • the individual sections of the vacuum connection can
  • Conductive means such as plastic tubing include. It is also possible to combine one or more of the named components in a single component. For example, the terminal 4 and the filter 6 could be realized in a single component, so that no conduit means must be present between these elements.
  • Figure 2 shows a further embodiment of the device according to the invention in a schematic representation, wherein the device designated by reference numeral 20 is connected via the terminal 4 to a vacuum dressing.
  • Vacuum bandage includes an air-impermeable wound cover 16, a
  • the vacuum dressing was applied to a wound site 15, the wound site 15 comprising the wound to be treated and the patient's intact skin surrounding the wound.
  • FIG. 1 that shown in FIG. 1, that shown in FIG. 1, that shown in FIG.
  • a liquid receptacle 9 in which the extracted from the wound of the patient body fluids 25, preferably in liquid form, are collected.
  • regions formed by ribs or projections or communicating chambers may be present, so that the collected body fluids are prevented from uncontrolled sloshing during a movement of the container.
  • the liquid receiving container has an inlet 26 for feeding the
  • the vacuum connection 5 comprises a further section, namely the interior of the liquid receiving container 9.
  • the outlet 27 is arranged in the upper region of the liquid receiving container 9.
  • a filter 6 which, when intact, can prevent the ingress of liquid into the section of the vacuum connection 5 leading to the pump and further downstream.
  • a liquid sensor 8 is provided between the filter 6 and the inlet 2 of the pump 1.
  • Liquid passage through the filter can occur, for example, in a filter which has already been delivered defective manufacturer. Furthermore, it is possible for a filter to break through during operation. Finally, it would be conceivable that due to a faulty operation of the device by the user no filter was used at all.
  • the electronic control unit 7 via the connection 1 1, the pump 1 (electrically or wirelessly) control.
  • the pump 1 electrically or wirelessly control.
  • Control unit 7 can start or stop the pump and regulates the speed of the pump.
  • operating parameters of the pump could optionally also be used, for example a tachometer signal output by the pump or the current consumption of the pump. Accordingly, it is also possible to exchange signals in the bidirectional direction via the connection 11. It is also conceivable to supply the electric pump 1 via the connection 1 1 at the same time with electricity, in which case an electrical connection is required.
  • the electronic control unit 7 can deactivate the pump 1 in order to prevent liquid from being sucked in and, if appropriate, an expulsion of body fluids via the outlet 3 into the interior of the appliance (and possibly additionally into the environment of the appliance) , Alternatively or additionally, the control unit 7 output a warning signal (optically or acoustically) to alert the user to the defective filter 6. Furthermore, the detected event can be recorded in a memory belonging to the electronic control unit 7 (not shown in FIG. 2).
  • the electronic control units 7 may be connected to control elements, in particular to a touchscreen display 23. The user of the device can control the therapy device via the controls and program if necessary.
  • the electronic control unit may include interfaces (eg, a USB port) such that external electronic components, such as a portable computer, may communicate with the computer
  • Control unit 7 can communicate.
  • the interfaces are not shown in FIG.
  • the component 22 is a power supply, which normally comprises a rechargeable accumulator for the mobile operation of the device and a power supply.
  • the electrically driven or electrically driven pump 1, the electronic control unit 7 and other electronic or electrical components such as the touch screen display 23 can be supplied with power.
  • FIG. 2 shows an optional silencer 14 which is connected to the outlet 3 of the pump 1 in order to reduce the operating noise of the device.
  • the muffler 14 may be odor absorbing substances,
  • the fluid system of the device extends from port 4 to the downstream port of muffler 14, which communicates with the atmosphere.
  • the fluid system of the device 20 may in turn be connected to the fluid system of the patient side
  • Components (16, 17, 18) communicate when the vacuum bandage is sealingly connected via terminal 4 to the therapy device. Corresponding is then a continuous fluid system is produced between the wound space of the patient and the opening of the muffler 14, wherein in the section between wound space and pump 1 during operation of the pump 1, a relative to the surrounding atmosphere reduced air pressure (negative pressure) is present. Fluids (especially wound secretions and air) are then used in the intended use of the
  • FIG. 3 shows a schematic representation of a further preferred embodiment of the device with a first housing part 31 and a second housing part 32.
  • the first housing part 31 comprises in addition to the negative pressure generating electrically driven or electrically driven pump 1 usually provided for repeated use components, ie in particular the liquid sensor 8, the electronic control unit 7, the power supply 22 and the touch screen display 23.
  • the single-use components of the device namely liquid receptacle 9 with filter 6 and port 4 (and any existing
  • the first housing part 31 comprises a housing in which or on which the aforementioned components are housed.
  • the second housing part 32 forms the liquid receiving container 9 and may comprise further components, for example the connection 4 or alternatively a line leading to the connection 4 (including the connection 4).
  • the second housing part 32 is manually attachable to the first housing part 31 of the device and of the first housing part 31 of the
  • the detachable connection of the two housing parts (31, 32) is preferably accomplished by means of a coupling means 24.
  • This may be, for example, a snap-in and manually releasable by actuators locking.
  • the filter 6 As shown in Figure 3, the filter 6
  • the filter 6 should have on its side facing the pump 1 a coupling element suitable for producing a pressure-tight connection, for example an annular seal, so that a vacuum communication between the container and the pump-side section of the vacuum connection 5 can be produced simultaneously when the housing parts are joined together ,
  • FIG. 4 illustrates a sensor module 40 with an optoelectronic sensor and hose holder which is suitable for use with the device according to the invention.
  • the optoelectronic sensor (not shown in FIG. 4) is integrated in the sensor module 40.
  • the sensor module 40 can either be applied directly to the main board of the device, which also carries the electronic control unit 7, or alternatively be connected to the electronic control unit by means of an electrical connection.
  • In the sensor module 40 can be arranged between the filter 6 and inlet 2 of the pump 1 conduit portion which a portion of
  • Vacuum connection 5 forms to be trapped.
  • Sensor modules suitable for the device are commercially available (for example OPB350 sensor from OPTEK Technology Inc., USA).
  • FIG. 5 a shows, by way of example, the sensor output in volts determined in a test as a function of the presence or absence of water in one
  • Plastic hose A higher output corresponds here to a higher light intensity measured at the sensor.
  • a plastic tube made of silicone with an outside diameter of 10 mm and an internal diameter of 6 mm was clamped in the holder of an OPB350 OPTEK sensor. Shown is the
  • Section i shows the sensor output before the hose has been clamped.
  • the diagram shows a very fast response of the sensor signal to the presence or absence of water in the hose. The rise or fall of the signal takes place in less than 200 milliseconds.
  • the ratio of Sensor output when comparing states ii (dry) and iii (water) is about 2.5.
  • the absolute sensor output is significantly influenced by the transparency (transmission) of the liquid present in the hose and by the material of the hose.
  • the sensor output first drops after insertion of the tube into the holder (sections i and ii) as the tube absorbs and scatters light. After passing through water, the sensor output increases because the water focuses the light beam. If a cloudy liquid, such as blood, is present in the tube, the sensor output will drop as compared to a dry tube (not shown in Figure 5). In the evaluation of the
  • FIG. 5 b shows, by way of example, the detection of liquid on the basis of the rate of change in time of the voltage dU / dt measured at the sensor.
  • the experimental setup corresponds to the situation shown in FIG. 5 a.
  • the measurement of the sensor output took place at intervals of 10 milliseconds.
  • Threshold for the rate dU / dt for example in volts per second (V / s).
  • V / s volts per second
  • the standard deviation ⁇ of the values determined for the rate of change dU / dt was first calculated. The measurement was carried out using a dry tube. The threshold (dU / dt) is then multiplied by the Standard deviation ⁇ obtained with a suitable multiplication factor.
  • the multiplication factor should be between 5 and 20 if possible. Preferably, the factor is 10 to 15, in particular 12 to 13.
  • a standard deviation ⁇ of 40.626 was determined when measuring the sensor fluctuation (dry tube). For this purpose, 1000 consecutive measured values were used (measurements were taken at a distance of 10 milliseconds).
  • the threshold (dU / dt) 500 V / s was therefore set as the threshold value for the detection of liquid entry into the hose. This value corresponds to 12.3 times the standard deviation ⁇ .
  • the maximum rate of change dU / dt is -18840.00 V / s.
  • FIG. 6 shows, by way of example, a warning message displayed on the touchscreen of the vacuum therapy unit, which according to a particularly preferred embodiment
  • Embodiment of the invention can be issued to a response of the liquid sensor out.
  • a sensor signal of the liquid sensor leads to the immediate shutdown of the pump to output the
  • Warning message and to block the negative pressure therapy unit for the user are displayed to the user as a (technical) problem ("problem-detected"). Unlocking the vacuum therapy unit and canceling the warning message can only be accomplished by a service technician of the equipment manufacturer, not by the user himself. This is a
  • Wound-secreted contaminated device is no longer used and instead checked expertly.
  • the appearance of the warning message on the touch screen should be combined with an audible warning to alert the user to the problem.

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

Abstract

L'invention concerne un dispositif fixe et/ou portable sur le corps d'un utilisateur destiné à mettre à disposition une pression négative pour réaliser la thérapie par pression négative de plaies sur un organisme humain ou animal. Le dispositif comprend une pompe actionnée électriquement ou actionnable électriquement générant une pression négative, un branchement pour une tubulure d'aspiration allant jusqu'à la plaie, un raccordement de pression négative, un filtre, une unité de commande électronique pour la pompe ainsi qu'un détecteur électronique de fluides pour détecter les fluides. L'invention concerne en outre l'utilisation d'un détecteur optoélectronique conjointement avec un dispositif pour mettre à disposition une pression négative afin de réaliser une thérapie par pression négative des plaies.
PCT/EP2015/076736 2014-11-19 2015-11-17 Détecteur électronique de fluides pour dispositif de thérapie par pression négative (tpn) Ceased WO2016079075A1 (fr)

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DE102014116910.7A DE102014116910A1 (de) 2014-11-19 2014-11-19 Elektronischer Flüssigkeitssensor für Unterdrucktherapie-Vorrichtung
DE102014116910.7 2014-11-19

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DE102019106601B3 (de) 2019-03-15 2020-06-18 Olympus Winter & Ibe Gmbh Verfahren und Aufbereitungssystem zum Aufbereiten eines Endoskops
JP2024525191A (ja) * 2021-06-25 2024-07-10 ティージェイ スミス アンド ネフュー リミテッド 陰圧創傷療法システムのための電子回路の液体侵入保護および設計

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