![]() Method for monitoring wound healing
专利摘要:
In a method and a device for monitoring the wound healing by means of at least one sensor arranged on or in a dressing material (12), the light absorption of the wound (11) is measured in at least two different wound depths. 公开号:AT513325A1 申请号:T9822012 申请日:2012-09-06 公开日:2014-03-15 发明作者: 申请人:Ima Integrated Microsystems Austria Gmbh; IPC主号:
专利说明:
The invention relates to a method for monitoring wound healing by means of at least one sensor arranged on or in a bandage material. The invention further relates to a dressing material for monitoring wound healing, comprising at least one sensor arranged on or in the dressing material in order to detect a property of the wound. The invention also relates to a plaster and a wound dressing comprising such a dressing material. To monitor wound healing, the bandage or patch usually needs to be removed. Not only is this painful but it can also adversely affect the healing process. However, regular monitoring of wounds is necessary to ensure the early detection of complications in wound healing. Wound healing is a dynamic and complex process involving multiple healing steps, each of which involves characteristic changes in the wound milieu and certain physical or chemical properties of the wound. The observation of the healing process of a wound usually takes place in practice through subjective assessment by the doctor or by nursing staff after optical control. The invention aims to provide a method and a dressing material with which wound healing can be monitored efficiently without having to remove the bandage or plaster. 2 · · · To achieve this object, according to a first aspect of the invention, a method for monitoring wound healing by means of at least one sensor arranged on or in a bandage material is provided, which is characterized in that the light absorption of the wound is measured in at least two different wound depths. The light absorption of a wound varies with the amount of blood present. In particular, blood accumulation leads to higher light absorption than healthy tissue. The extent of light absorption can thus be used as a measure of wound healing. Decisive in the context of the present invention is that the light absorption is measured in at least two different wound depths, whereby the course of wound healing can be better observed. The healing of a wound always begins at the deepest point of the wound, so that the depth of the wound decreases as the healing process progresses. The procedure according to the invention makes it possible in a simple manner to determine the depth of the wound, in order thereby to enable an efficient monitoring of the healing progress even without visual control by a physician. The measurement of the light absorption in at least two different wound depths allows a standardized procedure, so that the corresponding sensors work independently and without human control and therefore can be readily integrated into a wound dressing, plaster or the like. The measurement of light absorption can be done in a variety of ways. The light absorption does not have to be measured directly here, which is difficult in any case, but indirectly, i. E. for example, by detecting the light reflected from the wound. A preferred 3/26 • · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ··· Training, in this context, provides that the measurement of the light absorption involves irradiating the wound with light of a first wavelength and irradiating the wound with light of at least one second wavelength, the wavelengths being different from one another, and detecting the light reflected in the wound of the first Wavelength and detecting the reflected light of the second wavelength in the wound by means of a light sensor to obtain a first measured value and a second measured value. The reflected light represents the light absorption of the wound in the irradiated area, the higher the amount of light reflected, the less light is absorbed in the wound. Due to the use of light of different wavelength, light reflected from different wound depths can be detected. The longer-wavelength light penetrates deeper into the tissue and can therefore provide information on wound healing in a deeper wound area than the less penetrating, shorter-wave light. The evaluation of the absorption or reflection measured values for the purpose of monitoring wound healing can basically be carried out in various ways, whereby the procedure is preferably such that the first and the second measured value or respectively derived values are compared with one another and used as a measure for wound healing. More preferably, the comparing comprises forming a quotient of the first and second measured values or respectively derived values. Advantageously, further proceeding so that the first wavelength in the range of 600 - 750nm, in particular at about 645nm is selected and that the second wavelength in 4/26 Range of 780nm - 3yim, especially at about 850nm or 950nm is chosen. In order to improve the depth resolution of the light absorption, it is preferably provided that the light of the first wavelength is emitted at a smaller distance from the light sensor than the light of the second wavelength. This has the effect of promoting the detection of the reflection of the longer wavelength light from a deeper wound area. Advantageously, further properties of the wound are measured for complete wound monitoring. In this context, preference is given to further measuring the temperature, the oxygen saturation of the blood, the humidity and / or the pH of the wound. The indicated range of wound parameters allows a reliable detection of the condition of the wound. For example, it has been observed that the pH of a wound in the course of healing approaches the acidic region of healthy skin, i. has an increasing course, whereas a longer existing alkaline milieu indicates a halting wound healing. Furthermore, it has been observed that a local increase in the temperature of the wound usually indicates a wound infection. Proper moisture management is also important for wound healing and can be monitored by moisture measurement. In order to be able to grasp the development of the healing process as completely as possible and later make it comprehensible to the physician, it is preferably provided that the light absorption at regular intervals or measured continuously and the resulting light absorption measured values are stored in a data storage connected to the sensor, in particular arranged in or on the bandage and read out as needed via an interface and evaluated. This also applies to the additionally monitored wound properties. According to a further aspect of the invention, there is provided a wound healing monitoring dressing comprising at least one sensor disposed on or in the dressing to detect a property of the wound, the at least one sensor being an optical sensor arrangement for detecting the light absorption of the wound in at least two different wound depths is formed. By placing the sensor in or on the dressing material, when a dressing or patch is applied, a sensor is automatically placed so that various properties of the wound are automatically, i. can be detected without the intervention of the patient or the attending physician. The integration of the sensors into the dressing material is carried out in particular such that the at least one sensor faces the wound and preferably directly touches the wound. Preferably, the sensor arrangement comprises a first and a second light source and at least one light sensor, wherein the first and the second light source are arranged and configured to radiate light of mutually different wavelengths into the wound and the light sensor is arranged around the light reflected in the wound capture. Each light source can have its own 6/26 Be associated with the light sensor or it may be a single light sensor associated with both light sources together. Preferably, the first light source is designed to emit red light, preferably in the wave range of 600-750 nm, in particular approximately 645 nm. The second light source is preferably designed to emit infrared light, preferably in the wavelength range from 780 nm to 3 μm, in particular approximately 850 nm or approximately 950 nm. Advantageously, the first and the second light source are arranged at different distances from the light sensor. Preferably, the first and the second light source are each formed by an LED and the light sensor by a photodiode, so that a corresponding miniaturization succeeds. Preferably, the sensor arrangement comprises a control and evaluation circuit connected to the light sensor in order to separately detect the light emitted by the first light source and that emitted by the second light source and detected by the light sensor, and to supply it to a memory. The memory may in this case also be arranged in or on the dressing material and have an interface for reading out the stored data by means of an external reading device. The measurement data are thus stored for a longer period in the memory integrated in the wound dressing and can be used as required, e.g. read on the next hospital or doctor visit from an external device, displayed on a screen or printed and evaluated by a doctor. 7.26 Preferably, as already mentioned, a temperature sensor, a pH sensor, a moisture sensor and / or a sensor for detecting the oxygen saturation of the blood are additionally provided. All sensors are preferably selected so that they can be arranged in a corresponding miniaturization without noticeable impairment of wearing comfort in or on the bandage material. For example, the temperature sensor may be formed by a silicon thermistor. The moisture sensor may be formed by comb-like interdigitated electrode structures (IDE). The pH sensor may preferably comprise a pH-sensitive dye and an optical sensor which detects the color of the dye. The sensor for detecting the oxygen saturation of the blood is advantageously formed by an operating according to the pulse oximetric principle optical sensor array. The same LEDs and the same photodiode can be used for this as for measuring the light absorption. Preferably, all sensors are arranged on a common flexible printed circuit board. To protect the electronics can be provided that the circuit board is coated with biocompatible polydimethylsiloxane. The invention will be explained in more detail with reference to an embodiment schematically illustrated in the drawing. 1 shows a sensor arrangement on a printed circuit board and FIG. 2 shows the integration of the sensor arrangement in a wound dressing which rests on a wound. 8/26 ♦ · · · · · · · · · · · · · · The sensor system 1 in Fig. 1 comprises an LED 2 adapted to emit red light having a wavelength of 645nm, an LED 3 formed by infrared light having a wavelength of e.g. 850nm or 950nm, a PIN photodiode 4 for detecting the light reflection, an IDE structure 5 for detecting the moisture, a below the IDE structure 5 arranged silicon thermistor 6 for detecting the temperature, a pH-sensitive silicon layer 7, a below the silicon layer 7 arranged LED 8 and also arranged below the silicon layer photodiode 9 for optically detecting the discoloration of the pH-sensitive silicon layer. The support for the sensor system 1 forms a flexible printed circuit board 10. The entire sensor system is coated with biocompatible polydimethylsiloxane (PDMS). FIG. 2 schematically shows a wound 11 which is covered by a wound dressing 12, the sensor system 1 shown in detail in FIG. 1 being integrated into the wound dressing 12. This sensor system 1 rests directly on the wound 11 and is connected via a cable 13 and a plug 14 to a control and evaluation circuit 15. This control and evaluation circuit comprises a microprocessor 16, a battery 17 and an SD card 18. Starting from the dashed line 19, the components shown in the direction of the arrow 20 are formed as disposable components, while the components shown in the direction of the arrow 20 are formed as reusable components. These two component groups are in 9/26 Region of the connection between the plug 14 and the control and evaluation circuit 15 separable. The sensor system shown in Figure 1 was examined in an animal study with four pigs. Two superficial wounds were added to each animal by a split skin removal. After the procedure, one wound was provided with a wound dressing equipped with the sensor system according to the invention. The other wound was banded for comparison with no sensor system. The aim of the study was to check the data recording for the corresponding period of wound healing and to exclude a healing-delaying effect or toxicity of the sensor system. To avoid postoperative hemorrhage, measurement was started on day 3 of the study. No influence on the wounds could be detected. In Figs. 3 to 6, the sensor signals of one over the course of healing from day 3 to 14 are shown in an animal. It can be seen that particularly the ratio of the absorption or reflection of the wound tissue at different wavelengths can be regarded as a critical parameter for the evaluation of the healing process, see FIG. 5. The box plot in FIG. 7 shows the ratio of red to infrared light for all four animals. The entire trial period was divided into six consecutive phases. Especially in the later healing phase, a significant drop in the ratio can be seen. The boxes of the box plot of FIG. 7 show the median, the lower and the upper quartile (25% -75%), the whisker 1.5 IQR (99.3%), and the notch comparison intervals, which provide a ". ♦ · ································································································································································································· Furthermore, a hematoma test was performed to verify the validity of light absorption measurements. The results of this experiment are shown in FIG. The sensor assembly according to the invention was placed on the intact skin over a hematoma in the knee area of a patient (Figure 8, column "bruise"). For comparison purposes, identical sensor arrays were applied to intact reference posts, namely in the same knee area of the other leg (Figure 8, column "counter side") and at a location adjacent to the knee on both legs (Figure 8, column "reference left", " reference right "). The experiment shows the possibility to make statements about underlying tissue. Namely, the accumulation of blood in deeper tissue absorbs significantly more infrared light than the reference site on the other side (see FIG. 8). Due to the lower penetration depth, the differences in red light are significantly lower. With appropriate variation of the wavelength and due to the distance of the LEDs to the photodiode, a depth resolution can be achieved. 11/26
权利要求:
Claims (24) [1] ···· ···· • · ii *; 1. A method for monitoring the wound healing by means of at least one arranged on or in a bandage material sensor, characterized in that the light absorption of the wound in at least two different wound depths is measured. [2] 2. The method according to claim 1, characterized in that the measurement of light absorption comprises irradiating the wound with light of a first wavelength and irradiating the wound with light of a second wavelength, wherein the first and the second wavelength are different from each other, and detecting the in the wound of reflected light of the first wavelength and detecting the reflected light in the wound of the second wavelength by means of a light sensor to obtain a first measured value and a second measured value. [3] 3. The method according to claim 2, characterized in that the first and the second measured value or respectively derived values are compared with each other and used as a measure of the wound healing. [4] 4. The method of claim 3, wherein comparing comprises forming a quotient of the first and second measured values or respectively derived values. [5] 5. The method of claim 2, 3 or 4, characterized in that the first wavelength in the range of 600 - 750nm, in particular at about 645nm is selected and 12/26 ·· ·· ·· ····· ··· ················································································································································································································································ , especially at about 850nm or 950nm is chosen. [6] 6. The method according to any one of claims 2 to 5, characterized in that the light of the first wavelength is emitted at a smaller distance from the light sensor than the light of the second wavelength. [7] 7. The method according to any one of claims 1 to 6, characterized in that further the temperature and / or the oxygen saturation of the blood and / or the moisture of the wound and / or the pH of the wound is measured. [8] 8. The method according to any one of claims 1 to 7, characterized in that the light absorption measured at regular intervals or continuously and stored the light absorption measured values stored in a connected to the sensor, in particular a data storage arranged in or on the association and read out via an interface as needed and evaluated. [9] 9. dressing material for monitoring the wound healing, in particular for carrying out the method according to one of claims 1 to 8, comprising at least one arranged on or in the dressing material sensor to detect a property of the wound, characterized in that the at least one sensor as an optical sensor array designed to detect the light absorption of the wound in at least two different wound depths. [10] 10. bandage material according to claim 9, characterized in that the sensor arrangement comprises a first and at least one second light source and a light sensor 13/26 ·············································································. ··· ···· ···· ir The first and second light sources are arranged and configured to emit light of mutually different wavelengths into the wound and the light sensor is arranged to detect the light reflected in the wound. [11] 11. dressing material according to claim 10, characterized in that the first light source is designed to emit red light, preferably in the wavelength range of 600 -750nm, in particular about 645nm, and the second light source is formed to infrared light, preferably in the waveband from 780nm - 3pm, especially about 850nm or 950nm. [12] 12. bandage material according to claim 10 or 11, characterized in that the first and the second light source are arranged at different distances from the light sensor. [13] 13. bandage material according to claim 10, 11 or 12, characterized in that the first and the second light source is each formed by an LED and the light sensor of a photodiode. [14] 14. The dressing material according to claim 10, wherein the sensor arrangement comprises a control and evaluation circuit connected to the light sensor for separately detecting the light emitted by the first and the second light source and detected by the light sensor and to a memory. 14/26 ·· · · · · · ♦ ♦ ·· • t · · · · ir [15] 15. The dressing material according to claim 14, characterized in that the memory is arranged in or on the dressing material and has an interface for reading the stored data by means of an external reading device. [16] 16. Dressing material according to one of claims 9 to 15, characterized in that a temperature sensor and / or a pH sensor and / or a moisture sensor and / or a sensor for detecting the oxygen saturation of the blood and / or at least one sensor for detecting further sore characterizing Parameter is provided. [17] 17. bandage material according to claim 16, characterized in that the temperature sensor is formed by a silicon thermistor. [18] 18. The dressing material according to claim 16 or 17, characterized in that the moisture sensor is formed by comb-like interdigitated electrode structures. [19] 19. Dressing material according to claim 16, 17 or 18, characterized in that the pH sensor comprises a pH-sensitive dye and an optical sensor which detects the color of the dye. [20] 20. Dressing material according to one of claims 16 to 19, characterized in that the sensor for detecting the oxygen saturation of the blood is formed by an operating according to the pulsoximetrischen principle optical sensor arrangement. 15/26 [21] 21, dressing material according to one of claims 9 to 20, characterized in that all sensors are arranged on a common flexible printed circuit board. [22] 22. The dressing material according to claim 11, characterized in that the sensor arrangement is coated with biocompatible polydimethylsiloxane. [23] 23. A patch comprising a dressing material according to any one of claims 9 to 22. [24] 24. A wound dressing comprising a dressing material according to any one of claims 9 to 22. Vienna, 6 September 2012 Applicant by: Haffne Pate
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同族专利:
公开号 | 公开日 AT513325B1|2014-09-15| WO2014036577A1|2014-03-13|
引用文献:
公开号 | 申请日 | 公开日 | 申请人 | 专利标题 WO2001054580A1|2000-01-27|2001-08-02|National Research Council Of Canada|Visible-near infrared spectroscopy in burn injury assessment| WO2007144810A1|2006-06-12|2007-12-21|Koninklijke Philips Electronics N.V.|Body monitoring device, body data acquiring method and method of determining the presence, location and/or stage of a wound| US20090177051A1|2008-01-09|2009-07-09|Heal-Ex, Llc|Systems and methods for providing sub-dressing wound analysis and therapy| US9854975B2|2006-06-12|2018-01-02|Koninklijke Philips N.V.|Skin monitoring device, method of monitoring the skin, monitoring device, method of irradiating the skin, and use of an OLED| US8100834B2|2007-02-27|2012-01-24|J&M Shuler, Inc.|Method and system for monitoring oxygenation levels of a compartment for detecting conditions of a compartment syndrome| AU2008248261A1|2007-05-01|2008-11-13|The Brigham And Women's Hospital, Inc.|Wound healing device| US20100100160A1|2008-10-16|2010-04-22|Philometron, Inc.|Methods and devices for self adjusting phototherapeutic intervention| US8447375B2|2009-08-13|2013-05-21|J&M Shuler Medical, Inc.|Methods and dressing systems for promoting healing of injured tissue|EP3687380A1|2017-09-27|2020-08-05|Smith & Nephew plc|Ph sensing for sensor enabled negative pressure wound monitoring and therapy apparatuses| GB201809007D0|2018-06-01|2018-07-18|Smith & Nephew|Restriction of sensor-monitored region for sensor-enabled wound dressings| CN108992046A|2018-07-03|2018-12-14|西北工业大学|A kind of separate type surface of a wound monitoring system based on medical dressing|
法律状态:
2018-05-15| MM01| Lapse because of not paying annual fees|Effective date: 20170906 |
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申请号 | 申请日 | 专利标题 AT9822012A|AT513325B1|2012-09-06|2012-09-06|Method and device for monitoring wound healing|AT9822012A| AT513325B1|2012-09-06|2012-09-06|Method and device for monitoring wound healing| PCT/AT2013/000132| WO2014036577A1|2012-09-06|2013-08-13|Method for monitoring wound healing| 相关专利
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