PORTABLE NEGATIVE PRESSURE DEVICE
20170209630 · 2017-07-27
Inventors
- Johanna Klusmann (Neresheim, DE)
- Karina Beyrle (Langenau, DE)
- Axel ECKSTEIN (Heidenheim, DE)
- Jürgen Hofstetter (Heidenheim, DE)
- Pierre Croizat (Herbrechtingen, DE)
- Mark Hsieh (Cambridge, GB)
- James Stein (Cambridge, GB)
- Chris Dawber (Cambridge, GB)
Cpc classification
A61M2205/3317
HUMAN NECESSITIES
A61M2205/505
HUMAN NECESSITIES
A61M1/73
HUMAN NECESSITIES
A61M2205/52
HUMAN NECESSITIES
International classification
Abstract
A portable negative pressure wound therapy device adapted to be carried by a user, comprising an electrically actuated suction pump for draining wound fluids from a patient, at least one microelectronic controller, at least one electronic memory and a housing for containing the electrical and/or electronic components. The device further comprises at least one microelectronic impact sensor, wherein the impact sensor is adapted to detect an impact acting on the device.
Claims
1. A portable negative pressure wound therapy device adapted to be carried by a user, comprising: a housing that contains electrical and/or electronic components; an electrically actuated suction pump to drain wound fluids from a patient; at least one microelectronic controller; and at least one electronic memory; wherein the portable negative pressure wound therapy device further comprises at least one microelectronic impact sensor, and the at least one microelectronic impact sensor is adapted to detect an impact acting on the portable negative pressure wound therapy device.
2. The portable negative pressure wound therapy device according to claim 1, wherein the at least one microelectronic impact sensor is one or more selected from a group of linear acceleration sensors, gyration sensors, humidity sensors, temperature sensors, magnetic field sensors and atmospheric air pressure sensor.
3. The portable negative pressure wound therapy device according to claim 2, further comprising at least one linear acceleration sensor.
4. The portable negative pressure wound therapy device according to claim 1, wherein the portable negative pressure wound therapy device is adapted to record impact sensor data on the at least one electronic memory, the impact sensor data being based on the detected impact.
5. The portable negative pressure wound therapy device according to claim 4, wherein the portable negative pressure wound therapy device is adapted to record an impact if the impact is above a predetermined threshold level.
6. The portable negative pressure wound therapy device according to claim 5, wherein the predetermined threshold level for linear acceleration is an acceleration value selected from a range of 3 g to 100 g.
7. The portable negative pressure wound therapy device according to claim 1, further comprising: a linear acceleration sensor capable of detecting acceleration in the three axis of space; and a gyration sensor capable of detecting gyration in the three axis of gyration, wherein the linear acceleration sensor and the gyration sensor are components of a single microelectronic inertial measurement unit (IMU) integrated in a chip.
8. The portable negative pressure wound therapy device according to claim 1, wherein the at least one microelectronic impact sensor comprises a separate power supply, and the separate power supply is independent of a power supply supplying the electrically actuated suction pump and the microelectronic controller.
9. The Pportable negative pressure wound therapy device according to claim 1, further comprising a separate electronic memory, wherein the separate electronic memory is adapted to record impact sensor data and the separate electronic memory operates independent of the electronic memory used by the controller to store operating instructions.
10. The portable negative pressure wound therapy device according to claim 1, further comprising a real time clock, whereby the portable negative pressure wound therapy device is adapted to record a time of an impact detected by the at least one microelectronic impact sensor.
11. The portable negative pressure wound therapy device according to claim 1, wherein the at least one microelectronic impact sensor comprises a sleep-to-wakeup function, the sleep-to-wakeup function including: a sleep phase correlating with a lower sampling rate, the sleep phase being active when the portable negative pressure wound therapy device is switched off; a wake phase correlating with a higher sampling rate, the wake phase being active when the portable negative pressure wound therapy device is switched on; and a sleep-to-wake transition if the impact detected by the at least one microelectronic impact sensor is above a predetermined threshold level, the sleep-to-wake transition operates independent of whether the portable negative pressure wound therapy device is switched on or off.
12. The portable negative pressure wound therapy device according to claim 11, wherein the sampling rate during the sleep phase is between 1 Hz and 50 Hz and wherein the sampling rate during the wake phase is between 500 Hz and 2000 Hz.
13. The portable negative pressure wound therapy device according to claim 1, further comprising a remote interface to transmit impact sensor data to a remote device.
14. A method to record an impact condition to which a negative pressure therapy device was exposed, comprising: setting, using a controller, at least a first predetermined impact threshold; detecting, using an act sensor, an impact to which the negative pressure therapy device was exposed and, recording, using the controller, the impact if the impact detected by the impact sensor is above the first predetermined threshold.
15. The method according to claim 14, wherein the detected mpact includes at least one of linear acceleration and rotation.
16. The method of claim 14, further comprising: setting, using the controller, a second predetermined impact threshold, the second predetermined impact threshold being higher than the first predetermined impact threshold; and if the impact detected by the impact sensor is above the second predetermined impact threshold, then at least one of: (i) alarming a user, and (ii) locking the negative pressure wound therapy device.
17. The portable negative pressure wound therapy device according to claim 8, wherein the separate power supply is one of a battery or a capacitor.
18. The portable negative pressure wound therapy device according to claim 13, wherein the remote interface to transmit impact sensor data includes the interne.
19. The portable negative pressure wound therapy device according to claim 9, wherein the separate electronic memory is flash memory.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0083] Further characteristics, details, and advantages of the invention result from the appended patent claims and from the drawings and the following description of preferred embodiments of the invention. The drawings show:
[0084]
[0085]
[0086]
[0087]
[0088]
[0089]
[0090]
[0091] 7a Impact on bottom front face
[0092] 7b Impact on side face
[0093] 7c Orientation of the x-axis and the y-axis
[0094]
[0095] 8a Acceleration signals recorded during a drop from 1.0 m
[0096] 8b Acceleration signals recorded during a sitting to a chair movement of a test user
[0097] 8c Angular velocity signals recorded during the same drop from 1.0 m as in impact 8a
[0098] 8d Indication of the incidents occurring during the experiment of example 8a
[0099] 8e Acceleration signals recorded while a test user was walking down a stair carrying the portable negative pressure wound therapy device
[0100] 8f Acceleration signals recorded while the portable negative pressure wound therapy device was flipped to the front face
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0101] A simple negative pressure wound therapy device 1, which is in fluid communication with a wound 2 of a patient to be treated is shown in
[0102] In some embodiments, the portable negative pressure wound therapy device does not have a container for receiving the drained body fluids. Instead, the body fluids can be contained, for example, in the dressing. This is achieved by providing absorbent layers (not shown in
[0103]
[0104] It can also be seen from
[0105] In the preferred embodiment shown, a manually operable element 12 is provided in this grip recess 11 on the upper side of the device 1, for example, in the form of a pushbutton that acts on locking and back-gripping means (not shown). In the joined condition of the two housing parts 3 and 4, the locking or back-gripping means are in a locked condition holding the two housing parts 3, 4 together by positive action. Only upon operation of the operating element 12, the lock is released so that the housing parts 3, 4 can be separated from each other.
[0106]
[0107] In contrast to the very basic system shown in
[0108] Moreover, a pressure sensor 17 for measuring the pressure is provided in the tube section 15 between container 3 and suction pump 5. Its signals are sent to an electronic control unit, collectively identified by reference symbol 18, which performs open-loop and closed-loop control of the device 1 in total. The electronic control unit 18 comprises a microelectronic controller and at least one electronic memory. Also shown is the charging connection 8 for rechargeable batteries that are located in a compartment 19 and a connection 20 for a schematically indicated power supply unit 21. Reference symbol 22 indicates a display unit, preferably having a capacitive switch membrane (touchscreen). A user may control operation of the device via said touchscreen. The electrical connection to the electronic control unit 18 is indicated via electrical lines 23. The suction pump 5 is controlled by the electronic control unit 18 in which, by means of the signals of the pressure sensor 17, a pressure and vacuum closed-loop control is implemented with known open-loop and closed-loop control mechanisms (setpoint/actual value control mechanisms), so that the pressure value corresponding to the currently selected program is controlled in the tube section 15.
[0109] Also shown is an additional rinsing or aeration tube 24 that, only shown by way of example, leads through the container 3 and just like the suction tube 6 leads to the wound dressing 13. When the container 3 is attached in its intended assembly position on the first housing part 4, this rinsing tube 24 communicates with a tube section 25 provided in the first housing part 4 in which an electromagnetically operated valve 26 is provided that can be actuated by the electronic control unit 18 and connects the tube section 25 with the atmospheric air when it is open, so that an air current toward the wound via the rinsing tube 24 can be generated.
[0110] The device 1 and its electronic control unit 18 also feature a data interface 27, preferably a USB interface, by means of which the electronic control unit 18 or its method of operation can be programmed. In addition, device 1 comprises a speaker 28 which is connected to the control unit 18. The speaker can be used to generate acoustic alarm signals.
[0111] According to the invention, the portable negative pressure wound therapy device further comprises an impact sensor 29, which is capable of communicating with electronic control unit 18. As explained above, the electronic control unit 18 comprises a microcontroller. The impact sensor 29 is one or more selected from the group of linear acceleration sensors, gyration sensors, humidity sensors, temperature sensors, magnetic field sensors and atmospheric air pressure sensor. Preferably, the impact sensor 29 is a linear acceleration sensor, optionally in combination with a gyration sensor and/or a magnetic field sensor.
[0112] It is possible, that the impact sensor 29 communicates directly, by means of an interface, with the electronic control unit 18. In this embodiment (herein called an integrated impact sensor), the impact sensor 29 is an integrated component of the control system 18 of the device. Also, the impact sensor data are processed by the electronic control unit 18 and the sensor raw data and/or the processed data storage is controlled by the electronic control unit 18. The integrated impact sensor 29 is usually (but not necessarily) provided with electric energy by the main power supply system of the device.
[0113] More preferably, the impact sensor 29 is a component of a stand-alone impact sensor module. A stand-alone impact sensor module is explained in more detail in
[0114] Interaction of the impact sensor 29 with the control unit 18 is also shown in
[0115] The impact sensor 29 can conveniently be mounted to the same main board, on which electronic control unit 18 is sitting.
[0116] Proceeding to
[0117] The control unit includes elements/functions such as the microelectronic controller (microcontroller), a protection circuit for the power supply, a fuel gauge for the power supply, a charging circuit for the power supply, power converter circuits, a speaker controller and switching circuits for controlling the suction pump and the electromagnetic valve.
[0118] The peripheral electric/electronic components include a source of electric energy, preferably a rechargeable battery, the suction pump, preferably a membrane pump and at least one electronic memory typically including both ROM and RAM chips. In up-to date devices, the peripheral electric/electronic components may additionally include, for example, a vacuum valve for a rinsing fluid pathway (as exemplified in
[0119] The control unit is the central instance for controlling and monitoring function of the device.
[0120] According to the invention the peripheral components include an impact sensor, which may be an integrated impact sensor or preferably a stand-alone impact sensor module, each of which communicate with the microcontroller via an interface. The microcontroller receives impact sensor data. If an integrated impact sensor is used, the microcontroller receives the sensor raw data, for example acceleration data or temperature data. The raw data are processed as explained in detail above. If a stand-alone impact sensor module is used, the microcontroller receives the processed data and may, for example, display warnings to the user or lock the device.
[0121] The stand-alone impact sensor module shown in
[0122]
EXAMPLE 1
[0123]
[0124]
EXAMPLE 2
[0125]
[0126] The data corresponding to
[0127] The data corresponding to
[0128] The diagrams show the magnitude M.sub.a calculated from the recorded outputs of the three linear acceleration sensors included in a MEMS motion sensor (H3LIS331 DL from ST Sensor Technology, United Kingdom). M.sub.a was calculated as a relative value using the formula
M.sub.a={square root over ((a.sub.x.sup.2+a.sub.y.sup.2+a.sub.z.sup.2))}
wherein the values (a.sub.x, a.sub.y; a.sub.z) correspond to the output of the sensor channels measuring linear acceleration along the three space axis (x; y; z).
[0129] Suitable predetermined impact thresholds, for example impact thresholds for acceleration, can be set by repeatedly performing experiments of the type described in this example. The impact thresholds for acceleration will have to be determined for each type of device, because they depend on device specific parameters like stability, weight, material and shape of the device. The data displayed in this example indicate, that an adequate threshold will have to be above the non-detrimental impact (device carried by user while changing his position from standing to sitting, whereby a maximum magnitude M.sub.a value of 4 relative units was observed) and below the potentially detrimental impact (dropping the device from a height of 1 m to ground, whereby a maximum magnitude M.sub.a value of about 11 relative units was observed). In order to set adequate thresholds, a series of experiments of the type described in this example will have to be carried out.
[0130]
[0131]
s(height)=g(gravity)(t.sub.imt.sub.ff).sup.2
[0132] For the estimation of the height of the fall the air resistance is disregarded. In the case shown in
[0133]
[0134] The experiments shown in connection with this example 2 demonstrate, that an acceleration threshold, for example a threshold of 8 relative units for the exemplified case, can conveniently be determined by subjecting the device to a series of movement and crash conditions, which are non-detrimental or detrimental for the device, respectively. Exceeding of the threshold can serve as trigger, for example, to record impact sensor data on a memory, to provoke a warning message, to lock the device, to send a message to a remote server (if a remote interface is present) or to increase sampling rate of the sensor. It is also possible to use several (for example two or three) different thresholds resulting in different activities, if the threshold is exceeded. On preferred example is to use a lower threshold, for example 2 relative units to activate the sleep-to-wakeup function and to use a comparatively higher threshold, for example 8 relative units to display a warning message and/or lock the device. Examples for threshold dependent activities are described more in detail in the description of specific preferred embodiments above.