An evaluation system for medical dressings

Abstract

The present application relates to an evaluation system for medical dressings, comprising a suction unit, a collection unit, a detection unit and a processing unit, the suction unit, which is in communication with a medical dressing covering a wound of a patient, is capable of transmitting negative pressure to the medical dressing and pumping wound exudate out of the medical dressing in the form of a fluid, the processing unit, based on detection results obtained by one or more detection components in the detection unit, adjusts a preset time period for the activation of the collection unit, wherein the activation of the collection unit is at least automatically controlled based on the preset time period and / or manually controlled based on a switch of a treatment program. The evaluation system is used to determine the actual use of a medical dressing in a treatment work for different categories of wounds, so as to obtain the expected use of any medical dressing in a treatment work for a specified category of wounds.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more particularly to an evaluation system for medical dressings. Background Technology

[0002] NPWT (Negative Pressure Wound Therapy) is an advanced trauma treatment method that has developed in recent years. It differs from traditional wound care and negative pressure drainage techniques. NPWT primarily uses relatively low negative pressure (generally -55 mmHg to -175 mmHg) in an intermittent manner to treat wounds. Currently, NPWT is widely used for various acute and chronic wounds, including acute soft tissue defects, various chronic (pressure, vascular, diabetic) ulcers, surgical incision dehiscence or infection, etc. It is particularly suitable for chronic, difficult-to-heal wounds that are unresponsive to traditional surgical methods and wounds where immediate definitive surgical closure methods such as flap transplantation cannot be performed.

[0003] NPWT has a definite effect on promoting wound healing, involving a combination of factors such as increasing local blood flow, eliminating local edema, reducing the accumulation of wound exudate, inhibiting the growth of bacteria in the wound, promoting cell proliferation and granulation tissue growth, maintaining a moist environment in the wound and surrounding tissues, regulating collagenase and gelatinase activity, and alleviating post-traumatic immunosuppression.

[0004] CN111132605A discloses embodiments of devices, systems, and methods for monitoring wound pH. In some embodiments, the wound dressing includes one or more optical sensors configured to measure color changes in response to changes in the pH of a pH-sensitive adhesive. In some embodiments, the wound dressing may further include hydrophilic channels that guide wound exudate to the pH-sensitive material on the optical sensors. Such dressings may also be used in conjunction with negative pressure wound therapy systems.

[0005] CN111107814A discloses sensor positioning and optical sensing for a wound treatment dressing and system for implementing sensors. In some embodiments, a wound monitoring and / or treatment device may include a wound dressing configured to be positioned above a wound. The wound dressing may support one or more sensors. The one or more sensors may include a cluster of optical sensor arrays, which may include optical sensors and a single light source. In some embodiments, the wound dressing may include a substantially stretchable wound contact layer including a wound-facing side and a non-wound-facing side opposite the wound-facing side, the wound-facing side being configured to be positioned in contact with the wound. The non-wound-facing side of the wound contact layer may support a plurality of electronic components and a plurality of electronic connections connecting at least some of the plurality of electronic components. The electronic components may include one or more sensors configured to obtain measurements of the wound or the area around the wound, or both.

[0006] However, in existing technologies, medical dressings used for negative pressure wound therapy rarely provide visualization or information about the condition of the wound beneath the dressing. This may necessitate premature dressing replacement before the desired level of wound healing has occurred, or, for absorbent dressings, before they reach full absorbency to allow clinicians to examine wound healing and condition. Even though existing technologies monitor wound pH by guiding wound exudate to a pH-sensitive material on an optical sensor to provide wound condition information, various factors such as environment, light source, sensor, and / or sensitive material can affect the accuracy of the monitoring results. This makes it impossible to accurately assess medical dressings and predict wound healing, potentially leading to misjudgments of the patient's wound condition by healthcare professionals and resulting in suboptimal treatment outcomes.

[0007] Furthermore, on the one hand, there are differences in understanding among those skilled in the art; on the other hand, the applicant studied a large number of documents and patents when making this invention, but due to space limitations, not all details and contents were listed in detail. However, this does not mean that the present invention does not possess the features of these prior art. On the contrary, the present invention already possesses all the features of the prior art, and the applicant reserves the right to add relevant prior art to the background art. Summary of the Invention

[0008] In view of the shortcomings of the prior art, the present invention provides an evaluation system and method for medical dressings to at least solve the above-mentioned technical problems.

[0009] The present invention discloses an evaluation system for medical dressings, comprising: a suction unit for providing negative pressure to at least the medical dressing; a collection unit for collecting optical information of a patient's wound area; a detection unit for performing optical detection and / or electrochemical detection methods; and a processing unit for receiving and processing signals carrying data information transmitted by the collection unit and the detection unit.

[0010] A suction unit connected to a medical dressing covering a patient's wound can transfer negative pressure to the medical dressing and pump wound exudate out of the medical dressing in the form of a fluid. The processing unit adjusts the preset time period for starting the acquisition unit based on the detection results obtained by detecting wound exudate by one or more detection components in the detection unit. The start of the acquisition unit is at least automatically controlled based on the preset time period and / or manually controlled based on the switching of the treatment program. The optical information acquired by starting the acquisition unit includes at least wound-related image information and dressing-related image information.

[0011] Preferably, the method of treating the wound by closing the open wound with a dressing and connecting the dressing to a suction pump through a suction tube to generate negative pressure can reduce the pressure around the wound, increase blood flow in the wound's blood vessels, stimulate granulation tissue growth, fully drain exudate, reduce edema, fight infection, and accelerate wound healing. Preferably, the acquisition unit can continuously or intermittently acquire image information of the patient's wound area throughout the wound treatment process, wherein the image information includes at least wound-related image information and dressing-related image information. Furthermore, since patients cannot maintain the same posture throughout the wound treatment process, and the acquisition unit cannot adapt to patient movement to achieve dynamic tracking, the acquisition unit can preferably adopt an intermittent acquisition method, and be activated at least when the treatment program is switched during the wound treatment process. The treatment program switching is performed by medical personnel, wherein the activation of the acquisition unit can be automatically controlled based on a preset time period and / or manually controlled based on the switching of the treatment program. Preferably, the acquisition unit, which is automatically activated based on a preset time period, can acquire images of the wound area actively placed by the patient within the acquisition area. The processing unit can remind the patient in advance to prepare for the acquisition work and guide the patient's posture before the preset time period is reached. It can also notify the patient and / or caregivers and / or medical staff when the acquisition unit, which is activated after the preset time period, fails to acquire the correct image information from the acquisition area. The reminders, guidance, and / or notifications can be implemented through one or more of voice, text, images, and video. The acquisition unit, which is manually activated based on the switching of treatment procedures, can be manually operated by medical staff. The treatment procedure can generally include the wound period when the wound is exposed to the external environment and the dressing period when the wound is covered by medical dressings. The switching of treatment procedures is the back-and-forth switching between the wound period and the dressing period.

[0012] According to a preferred embodiment, the acquisition unit acquires optical information of the patient's wound area without directly contacting the medical dressing and / or wound, so that the processing unit can analyze the visible state of the medical dressing and / or wound, wherein the processing unit also evaluates the medical dressing and / or wound based at least on the detection results of the detection unit.

[0013] Preferably, the visible state refers to the state information that can be intuitively obtained from the external environment without direct contact with the dressing and / or wound. Preferably, the patient's wound area can be the area defined by the location of the wound and the surrounding skin, or the area covered by the medical dressing on the patient's wound. Preferably, the acquisition unit can acquire environmental information so that the processing unit can correct the image information based on the external environment, wherein the environmental information acquired by the acquisition unit can be at least parameters that can affect the processing unit's recognition of the image of the patient's wound area, such as ambient temperature, ambient light, etc. Preferably, the acquisition unit can acquire the information of the skin surrounding the patient's wound (e.g., skin color, skin folds, natural discoloration, etc.) when acquiring the image information of the patient's wound area to establish standard skin data for the patient, which at least includes skin color in a normal state, wherein the skin surrounding the patient's wound is at least skin unaffected by the wound, i.e., corresponding to the patient's normal skin color. Further, when the image information acquired by the acquisition unit does not contain relevant information about the surrounding skin, the setting position and / or angle of the acquisition unit can be appropriately adjusted to ensure the integrity of the image information acquisition.

[0014] According to a preferred embodiment, the suction pump of the suction unit is connected directly or indirectly to the medical dressing via a suction tube through a suction container, wherein a valve with an opening and closing degree controlled by the processing unit is provided on the suction tube connected to the input end of the suction container.

[0015] According to a preferred embodiment, the processing unit controls a valve to introduce at least a portion of the wound exudate in the suction line into one or more detection components in the detection unit for detection.

[0016] According to a preferred embodiment, the first detection component configured in the detection unit can detect the pH of wound exudate by utilizing the different optical properties of pH-sensitive materials under different pH environments. When the optical sensor in the first detection component, which is used to acquire optical information related to the pH-sensitive material, is incorporated into the acquisition unit, the preset time period for the acquisition unit to start is at least based on the detection results of the second detection component and / or the third detection component.

[0017] According to a preferred embodiment, the second detection component is capable of detecting the oxygen concentration in wound exudate using an oxygen-sensitive material, wherein the second detection component is disposed within an aspiration container or aspiration tubing.

[0018] According to a preferred embodiment, the third detection component can introduce labeled antibodies or aptamers to bind to targets in wound exudate, and analyze the conjugates after the reaction by optical detection and / or electrochemical detection methods. The third detection component is configured with a reaction chamber and a detection chamber connected in a controllable on / off manner, and the reaction chamber is arranged in a position that takes precedence over the detection chamber.

[0019] Preferably, the above configuration allows the negative pressure wound therapy plan and target detection to be completed simultaneously through the suction unit. The detection of the target does not interrupt the maintenance of negative pressure or affect the treatment process, and the treatment plan can be improved and adjusted in a timely manner based on the detection results.

[0020] According to a preferred embodiment, when the medical dressing is replaced, the evaluation parameters related to wound healing generated by the processing unit based on the optical information collected by the acquisition unit on the open wound can be obtained by comparing the actual healing amount and the predicted healing amount of the wound, so as to determine the actual effect of the medical dressing under the current usage conditions and corresponding usage methods.

[0021] Preferably, the assessment parameters related to wound healing can be obtained based on a comparison between the actual healing amount and the predicted healing amount, wherein the healing amount can be characterized by the percentage reduction in wound area. Preferably, the therapeutic effect of the previous dressing sequence can be evaluated based on the assessment parameters related to wound healing, to determine the degree of matching between the dressing and the patient's wound symptoms during the previous application. This allows for adjustment of the initial value of the predicted healing amount for the next dressing sequence, resulting in a more accurate prediction of the wound healing degree during subsequent applications, particularly improving the accuracy of predicting the treatment time and effect throughout the entire treatment course. Preferably, the processing unit can calculate the initial value of the predicted healing amount for the next dressing sequence based on the current state of the patient's wound, and continuously correct the predicted healing amount based on the detection results obtained by the detection unit, ensuring that the corrected predicted healing amount and the final actual healing amount are within a threshold range, thereby guaranteeing the accuracy of the assessment system.

[0022] The present invention also discloses an evaluation method for medical dressings. The evaluation method uses the aforementioned evaluation system to determine the actual use of medical dressings in the treatment of different types of wounds, so as to obtain the expected use of any medical dressing for the treatment of a specified type of wound, wherein the use includes the conditions of use, the method of use and / or the effect of use.

[0023] According to a preferred embodiment, the evaluation method can determine the recommended use conditions for any medical dressing, wherein the medical dressing that meets the recommended use conditions has an advantage in the expected use effect at least in the treatment of the same type of wound, and the advantage is obtained by comparison with all medical dressings that can be obtained under existing treatment conditions. Attached Figure Description

[0024] Figure 1 This is a simplified schematic diagram of the module connection relationship of an evaluation system according to a preferred embodiment of the present invention.

[0025] List of reference numerals

[0026] 100: Suction unit; 110: Suction pump; 120: Suction pipeline; 130: Suction container; 140: Valve; 200: Acquisition unit; 300: Detection unit; 310: First detection component; 320: Second detection component; 330: Third detection component; 400: Processing unit; 500: Medical dressing. Detailed Implementation

[0027] The following is a detailed explanation with reference to the accompanying drawings.

[0028] Figure 1 This is a simplified schematic diagram of the module connection relationship of an evaluation system according to a preferred embodiment of the present invention.

[0029] Example 1

[0030] The present invention discloses an evaluation system for medical dressings 500, which can be used in conjunction with one or more medical dressings 500, so that when the medical dressing 500 is applied to a patient's wound, the evaluation system can collect the wound status through the medical dressing 500 and promote wound healing.

[0031] Preferably, in this invention, the evaluation system can monitor the dressing and wound status during wound treatment on a human or animal body. In this invention, "wound" can refer to any wound on a human or animal body, and any reference to the body in this invention can refer to a human or animal body. "Wound treatment" in this invention can involve preventing or minimizing damage to physiological or living tissues, or involve the healing of damaged tissues.

[0032] Preferably, in this invention, a "wound" can include damage to living tissue that may be caused by cutting, striking, or other impact, typically involving a cut or rupture of the skin. Optionally, a wound can include chronic or acute wounds, wherein an acute wound may be caused by surgery or trauma and may undergo various healing stages within a projected timeframe; a chronic wound typically begins as an acute wound and may become chronic due to factors such as compromised immune function, thus prolonging recovery time, when an acute wound does not follow healing stages.

[0033] Preferably, in this invention, "chronic wounds" may include, for example, venous ulcers, diabetic ulcers, peripheral artery disease, pressure sores, or bullous epidermolysis, etc.

[0034] Preferably, other wounds in this invention include, but are not limited to, abdominal wounds or other large or open wounds, which may be caused by surgery, trauma, sternotomy, fasciotomy, or by other conditions, lacerations, acute wounds, chronic wounds, subacute and lacerated wounds, traumatic wounds, flaps and skin grafts, lacerations, abrasions, contusions, burns, diabetic ulcers, pressure sores, stomas, surgical wounds, traumatic ulcers and venous ulcers, etc.

[0035] Preferably, the assessment system can use negative pressure wound therapy to perform the above data acquisition protocol and / or healing treatment protocol, wherein negative pressure wound therapy can be used to treat open or chronic wounds that are too large to close spontaneously or otherwise fail to heal by applying negative pressure to the wound site. This involves placing a fluid-impermeable or semi-permeable covering over the wound, which can be sealed to the patient's tissues surrounding the wound so that a negative pressure source (e.g., a vacuum pump) communicating with the underside of the covering can create and maintain negative pressure between the covering and the wound.

[0036] Preferably, in this invention, the negative pressure generated by "negative pressure wound therapy" can maintain a moist and warm environment to promote wound healing. Specifically, the pressure gradient generated between the wound and the negative pressure source can reduce wound edema; pressure below atmospheric pressure can increase blood flow; can reduce inflammatory response; can alter bacterial load; can clean the wound and inhibit bacterial growth, etc.

[0037] Preferably, the covering placed above the wound can be a medical dressing 500, especially a medical dressing 500 suitable for negative pressure wound therapy. The medical dressing 500 can be placed in a manner that forms a sealed cavity above the wound, wherein "above the wound" refers to the side of the wound facing the external environment, and not merely to the upper position in space.

[0038] According to a preferred embodiment, the evaluation system may be configured with a data acquisition unit 200 and a processing unit 400 signal-connected to the data acquisition unit 200, such that the processing unit 400 can at least receive optical information (e.g., image information) acquired by the data acquisition unit 200 for the patient's wound area, thereby analyzing the visible state of the medical dressing 500 and / or the wound. The visible state refers to the state information that can be intuitively obtained from the external environment without direct contact with the medical dressing 500 and / or the wound. Further, the patient's wound area may be the area defined by the location of the wound and its surrounding skin, or the area covered by the medical dressing 500 on the patient's wound.

[0039] Preferably, the acquisition unit 200 can acquire environmental information so that the processing unit 400 can correct the image information based on the external environment. The environmental information acquired by the acquisition unit 200 can be at least parameters that can affect the processing unit 400 in recognizing the image of the patient's wound area, such as ambient temperature and ambient light.

[0040] Preferably, the acquisition unit 200 can acquire information about the surrounding skin (e.g., skin color, skin folds, natural discoloration, etc.) when acquiring image information of the patient's wound area to establish standard skin data for the patient. This data includes at least the skin color under normal conditions, wherein the skin surrounding the wound area is at least skin unaffected by the wound, corresponding to the patient's normal skin color. Furthermore, when the image information acquired by the acquisition unit 200 does not contain relevant information about the surrounding skin, the position and / or angle of the acquisition unit 200 can be appropriately adjusted to ensure the integrity of the image information acquisition.

[0041] Preferably, the acquisition unit 200 can continuously or intermittently acquire image information of the patient's wound area throughout the wound treatment process. The image information includes at least wound-related image information and image information related to the medical dressing 500. Furthermore, since the patient cannot maintain the same posture throughout the wound treatment process, the acquisition unit 200 cannot adapt to the patient's movement and dynamically follow them. Therefore, the acquisition unit 200 can preferably adopt an intermittent acquisition method, and is activated at least when the treatment program is switched during the wound treatment process. The treatment program switch is performed by medical personnel. The activation of the acquisition unit 200 can be automatically controlled based on a preset time period and / or manually controlled based on the switching of the treatment program. Preferably, the acquisition unit 200, which is automatically activated based on a preset time period, can acquire images of the wound area actively placed by the patient within the acquisition area. The processing unit 400 can remind the patient to prepare for the acquisition work and guide the patient's posture before the preset time period is reached. It can also notify the patient and / or caregivers and / or medical staff when the acquisition unit 200, which is activated after the preset time period, fails to acquire the correct image information from the acquisition area. The reminders, guidance, and / or notifications can be implemented through one or more of voice, text, images, and video. The acquisition unit 200, which is manually activated based on the switching of the treatment program, can be manually operated by medical staff. The treatment program can generally include the wound period when the wound is exposed to the external environment and the dressing period when the wound is covered by the medical dressing 500. The switching of the treatment program is the back-and-forth switching between the wound period and the dressing period.

[0042] Preferably, in the first switching procedure from the wound stage to the dressing stage, an unused new medical dressing 500 is applied to the wound; in the second switching procedure from the dressing stage to the wound stage, the used old medical dressing 500 is removed from the wound. Here, "new" and "old" for the medical dressing 500 only refer to its usage status and sequence. The old medical dressing 500 in the previous sequence is replaced by the new medical dressing 500 in the next sequence after use. This does not represent the age of the production date or manufacturing date, but medical dressings with earlier production or manufacturing dates can be prioritized in the earlier sequence. Furthermore, medical personnel can manually activate the collection unit 200 to collect data on the exposed wound or the covered medical dressing 500 before and after completing the first and / or second switching procedures.

[0043] Preferably, before executing the first switching procedure, the acquisition unit 200 can acquire image information of the current wound and surrounding skin to determine the current wound status. After executing the first switching procedure, the acquisition unit 200 can acquire image information of the area covered by the medical dressing 500 to determine the adhesion position and adhesion status of the medical dressing 500. Before executing the second switching procedure, the acquisition unit 200 can acquire image information of the area covered by the medical dressing 500 to determine the current cleanliness and / or integrity of the medical dressing 500 (e.g., the degree of peeling of the medical dressing 500). After executing the second switching procedure, the acquisition unit 200 can acquire image information of the current wound (e.g., the dryness of the wound) and surrounding skin to determine the degree of wound healing after a treatment cycle corresponding to a position sequence of medical dressings 500. This allows for timely adjustment of subsequent treatment plans and prediction of wound healing status.

[0044] Preferably, the processing unit 400 may include image processing, object detection, artificial intelligence and / or machine learning when performing the evaluation.

[0045] For example, if the image information acquired by the acquisition unit 200 shows that the color of the patient's wound area is too white compared to the skin color under normal conditions, or if the image information acquired by the acquisition unit 200 shows that the medical dressing 500 does not completely cover the wound, it indicates that the setting of the medical dressing 500 in the first switching procedure is unreasonable (e.g., the bandage is too tight), and the processing unit 400 can remind the medical staff to make timely adjustments.

[0046] According to a preferred embodiment, a medical dressing 500 placed on a patient's wound is sealably connected to a suction unit 100 of an assessment system. The suction unit 100 includes at least a suction pump 110 that can serve as a negative pressure source and a suction tubing 120 whose two ends can be connected to the medical dressing 500 and the suction pump 110, respectively. A first end of the suction tubing 120 is connected to the medical dressing 500, and a second end is connected to the suction pump 110, so that wound exudate can be pumped out of the medical dressing 500 in fluid form or negative pressure can be transferred from the suction pump 110 to the medical dressing 500. This method of treating the wound by closing the open wound with the medical dressing 500 and generating negative pressure through the suction tubing 120 connected to the suction pump 110 can reduce pressure around the wound, increase blood flow in the wound's blood vessels, stimulate granulation tissue growth, adequately drain exudate, reduce edema, fight infection, and accelerate wound healing.

[0047] Preferably, in this invention, depressurization or negative pressure (e.g., can be expressed as -X mmHg, where X is a numerical value) represents the pressure level relative to normal ambient atmospheric pressure (760 mmHg). Therefore, a negative pressure value of -X mmHg refers to an absolute pressure X mmHg lower than 760 mmHg, in other words, it reflects an absolute pressure of (760-X) mmHg.

[0048] Preferably, in this invention, the negative pressure range provided by the suction pump 110 is approximately between -20 mmHg and -200 mmHg.

[0049] Preferably, the suction unit 100 may also be configured with a suction container 130 for temporarily containing wound exudate, so that the input and output ends of the suction container 130 can be connected to the medical dressing 500 and the suction pump 110 respectively through suction lines 120 on both sides, so that when the suction pump 110 generates suction, the wound exudate is introduced into the suction container 130. The suction line 120 connected to the input end of the suction container 130 may be equipped with a valve 140 controlled by the processing unit 400 to adjust the amount of wound exudate introduced.

[0050] According to a preferred embodiment, the evaluation system may be configured with a detection unit 300 for analyzing at least wound exudate, wherein the detection unit 300 may be configured with a plurality of detection components depending on the detection target.

[0051] Preferably, the detection unit 300 may be configured with a first detection component 310 for detecting pH. The first detection component 310 may utilize any existing pH-sensitive material mixed in wound exudate to change to a specific color or provide a suitable indicator for detecting the color change of the pH-sensitive material by an optical sensor.

[0052] Optionally, pH-sensitive materials may include: pH-sensitive dyes, pH-sensitive pigments, pH-sensitive inks, pH-sensitive superabsorbents, pH-sensitive adhesives or non-adhesive gels, pH-sensitive adhesives or non-adhesive foams, pH-sensitive hydrophilic polymers, pH-sensitive hydrophobic polymers, or other similar materials, such as polyurethane gel matrices.

[0053] Preferably, the pH-sensitive material can be in the form of a triarylmethane dye, a fluorescent dye, or a benzoazo compound. The benzoazo compound may be in the following forms: 2-[4(2-hydroxyethylsulfonyl)-phenyl]diazeninyl]-4-methylphenol, 1-hydroxy-4-[4(hydroxyethylsulfonyl)-benzoazo]-naphthalene-2-sulfonate, 2-fluoro-4-[4[(2-hydroxyethylsulfonyl)-benzoazo]-6-methoxyphenol, 4-[4-(2-hydroxyethylsulfonyl)-benzoazo]-2,6-dimethoxyphenol, or other suitable benzoazo compounds and / or combinations thereof.

[0054] Preferably, different types of pH-sensitive materials can exhibit different colors under different pH conditions, and some pH-sensitive materials can further include color change gradients, meaning that the color or chromaticity of the pH-sensitive material can be acquired by an optical sensor. Furthermore, selecting specific pH-sensitive materials can achieve higher resolution within a narrow pH range relevant to the wound, where the wound's pH can indicate both the wound's healing status and other wound conditions such as infection.

[0055] Preferably, the optical sensor of the first detection component 310 can be embedded in the medical dressing 500 to directly acquire optical information related to the pH-sensitive material, or it can be set as an external device without being embedded in the medical dressing 500. Further, the optical sensor set as an external device can be integrated into the acquisition unit 200 to acquire optical information through the acquisition unit 200. The preset time period related to activation of the acquisition unit 200 set in the above manner is flexibly adjustable, and the adjustment method is determined based on the detection data acquired by other detection components.

[0056] Preferably, the detection unit 300 may be configured with a second detection component 320 for detecting oxygen concentration. The second detection component 320 can utilize any existing oxygen-sensitive material mixed in wound exudate and excited under appropriate light conditions to determine the oxygen concentration in the wound environment by measuring the lifetime and strength of the oxygen-sensitive material. The oxygen-sensitive material can be encapsulated within microporous beads. Preferably, the second detection component 320 may include a light source and an optical sensor. The second detection component 320 may be configured within the aspiration container 130 or the aspiration tubing 120.

[0057] Preferably, the detection unit 300 may be configured with a third detection component 330 for detecting a target analyte, wherein the target analyte may be, for example, a pro-inflammatory cytokine and / or a protease. Inflammatory cytokines are a class of endogenous polypeptides mainly produced by immune system cells, possessing many potent biological effects and mediating various immune responses; they can exacerbate diseases. Conversely, anti-inflammatory cytokines are certain cytokines with biological effects that inhibit inflammatory responses. Examples include IL-1Ra and IL-10, which play important roles in controlling the degree of inflammatory responses and immune responses. Proteases are any enzyme that performs proteolysis, i.e., a class of enzymes that hydrolyze protein peptide chains.

[0058] Preferably, the target may include basic metabolites (BMPs) such as glucose, calcium, sodium, potassium, carbon dioxide and / or chloride, and may also include matrix metalloproteinases and bone morphogenetic proteins.

[0059] Preferably, the third detection component 330 can introduce a relatively small amount of wound exudate using valve 140, and can introduce labeled antibodies or aptamers to bind to the target substance in the wound exudate. The conjugate after the reaction is analyzed by optical detection and / or electrochemical detection methods. Preferably, the third detection component 330 can be configured with a reaction chamber and a detection chamber connected in a controllable on / off manner, wherein the reaction chamber is arranged in a priority manner over the detection chamber, so that the wound exudate introduced from the aspiration catheter can enter the reaction chamber first and bind to the labeled antibody or aptamer added to the reaction chamber. After the reaction is completed, the conjugate is introduced into the detection chamber. Further, the conjugate analyzed in the detection chamber can be led downstream of the aspiration catheter, wherein the conjugate can be temporarily stored, for example, in the aspiration container 130. The above configuration allows the negative pressure wound therapy plan and the detection of the target substance to be completed simultaneously through the aspiration unit 100, and the detection of the target substance does not interrupt the maintenance of negative pressure or affect the treatment process, and can also make timely improvements and adjustments to the treatment plan based on the detection results.

[0060] Preferably, the reaction chamber and the detection chamber can be configured with a plurality of microfluidic channels, wherein the microfluidic channels in the detection chamber directly correspond to and communicate with the microfluidic channels in the reaction chamber. Preferably, each microfluidic channel in the reaction chamber can pre-introduce labeled antibodies or aptamers in a non-overflow manner, wherein the microfluidic channels in the reaction chamber can be equipped with microfluidic switches for switching microfluidic channels. Preferably, a resin can be disposed between the microfluidic channel and the microfluidic switch, which can absorb water and swell upon contact with wound exudate to push the microfluidic switch to move the pad connected to it and close the current microfluidic channel. Then, as the pad continues to move and contact the next sequence of microfluidic channels, the next sequence of microfluidic channels is opened, thereby completing the automatic switching of channels.

[0061] According to a preferred embodiment, the processing unit 400 can infer the dressing status and wound status in the current time series based on the detection data acquired by the detection unit 300, and can compare the dressing status and wound status in the current time series with those in the previous time series to determine the degree of change. Preferably, when it is determined that the dressing status is decreasing at an accelerated rate, the preset time period for controlling the acquisition unit 200 to start can be set in a gradually shortened manner, that is, the preset time period is a variable, non-fixed period, and its setting can be based on the detection data acquired by the detection unit 300. Based on the shortened preset time period, the acquisition unit 200 can acquire image information of the patient's wound area from the outside at a relatively higher frequency to calibrate the internal and external status of the medical dressing 500, wherein the calibration method must at least refer to the time when the medical dressing 500 has been put into use. Furthermore, when the previous medical dressing 500 is replaced by the next medical dressing 500, the preset time period can be reset. The reset data can be determined based on the usage time of the previous medical dressing 500 and the degree of wound healing during the usage process.

[0062] According to a preferred embodiment, when the previous medical dressing 500 is changed, the acquisition unit 200 can acquire optical information from the open wound (the wound exposed to the external environment) to collect light of a specified wavelength reflected from the patient's wound area, thereby enabling the processing unit 400 to generate an image with multiple pixels based on the data signal containing optical information sent by the acquisition unit 200. Preferably, the specified wavelength can be in the range of 420±20 nm, 525±35 nm, 581±20 nm, 620±20 nm, 660±20 nm, 726±41 nm, 820±20 nm, or 855±30 nm. The processing unit 400 can determine one or more feature vectors based on the reflection intensity value of each pixel in a subset of the multiple pixels at the specified wavelength to generate at least one scalar value through a learning algorithm, corresponding to an evaluation parameter related to wound healing within a set time period. Preferably, the learning algorithm may include an ensemble of random forests or an ensemble of classifiers.

[0063] Preferably, at least one scalar value may include multiple scalar values, each of which corresponds to the healing probability of a pixel in the subset or a subgroup of pixels in the subset.

[0064] Preferably, the processing unit 400 may also output visual information of multiple scalar values ​​to be displayed to the user (e.g., healthcare worker) in a visual manner. Further, the visual information may include specific visual information selected based on the healing probability of each pixel corresponding to the subset to display the image of that pixel, wherein pixels associated with different healing probabilities can be displayed with different visual information.

[0065] Preferably, the processing unit 400 can automatically divide multiple pixels in the generated image into wound-related pixels and non-wound-related pixels using a segmentation algorithm, such as a convolutional neural network. The non-wound-related pixels may include one or more of wound-healing-related pixels, surrounding normal skin-related pixels, and background-related pixels. Preferably, the convolutional neural network segmentation algorithm may include at least one of U-Net with multiple convolutional layers and SegNet with multiple convolutional layers.

[0066] Preferably, the assessment parameters related to wound healing can be obtained based on a comparison between the actual healing amount and the predicted healing amount, wherein the healing amount can be characterized by the percentage reduction in wound area. Preferably, the therapeutic effect of the previous medical dressing 500 during its previous use can be evaluated based on the assessment parameters related to wound healing, to determine the degree of matching between the medical dressing 500 and the patient's wound symptoms during the previous use. This allows for adjustment of the initial value of the predicted healing amount of the next medical dressing 500, resulting in a more accurate prediction of the wound healing degree during subsequent use, particularly improving the accuracy of predicting the treatment time and effect of the entire treatment course. Preferably, the processing unit 400 can calculate the initial value of the predicted healing amount of the next medical dressing 500 based on the current state of the patient's wound, and can continuously correct the predicted healing amount based on the detection results obtained by the detection unit 300, so that the corrected predicted healing amount and the final actual healing amount are limited within a threshold range, thereby ensuring the accuracy of the assessment system.

[0067] Preferably, based on the change in wound area, the processing unit 400 can remind medical staff to adjust the coverage position and / or area of ​​the medical dressing 500 when changing the next medical dressing 500 in the sequence. When the first switching procedure of this round is completed, the acquisition unit 200 can acquire images of the coverage position and / or area of ​​the medical dressing 500 to verify the rationality of the new medical dressing 500 setting.

[0068] According to a preferred embodiment, the evaluation system may be configured with a transmission unit connected to the cloud to upload the usage process and treatment effect of this type of medical dressing 500 during the current wound treatment of the patient, in order to build a cloud database. The patient's basic information, chief complaint, and the diagnosis results of medical staff will be uploaded together, so that wound treatment processes with the same symptoms can be classified into the same category by the cloud. When users (usually medical staff) encounter new patients requiring wound treatment, they can download relevant data from multiple sets of wound treatment processes with the same category of symptoms through the cloud to compare and obtain the relatively optimal usage process and treatment effect of the medical dressing 500. This allows them to determine the relevant settings for the upcoming wound treatment process, such as the selection of pH-sensitive materials, oxygen-sensitive materials, labeled antibodies or aptamers, and / or the initial value of the preset time period automatically started by the acquisition unit 200, which can be obtained from cloud big data calculations.

[0069] Example 2

[0070] This embodiment is a further improvement on embodiment 1, and repeated content will not be described again.

[0071] This invention also discloses an evaluation method for medical dressings 500. This evaluation method can use any of the evaluation systems described in Example 1 to determine the actual use of medical dressings 500 in the treatment of different types of wounds, to obtain the expected use conditions, corresponding expected use methods, and expected effects that may be obtained for different patients for any medical dressing 500. This facilitates medical personnel in matching the most suitable medical dressing 500 from those meeting the expected use conditions in the cloud when treating the same type of wound, and allows the expected use method to be implemented as a recommendation. In other words, this evaluation method can determine the recommended use conditions for any medical dressing 500, wherein the medical dressing 500 meeting the recommended use conditions has an advantageous position in the expected effects that may be obtained in the treatment of the same type of wound. This advantage is obtained by comparing it with all medical dressings 500 available under existing treatment conditions.

[0072] Preferably, the usage of any medical dressing 500 in the treatment of different types of wounds can be evaluated by uploading real treatment results and / or pre-entering experimental data to the cloud in real time. The usage includes usage conditions and / or usage methods and / or usage effects.

[0073] Preferably, the evaluation method of the present invention can be used to evaluate medical dressings 500 whose usage is unknown, such as newly developed medical dressings 500. Preferably, the evaluation method of the present invention can be used to evaluate medical dressings 500 used for specific conditions, such as newly discovered wound types.

[0074] It should be noted that the specific embodiments described above are exemplary. Those skilled in the art can devise various solutions inspired by the disclosure of this invention, and these solutions all fall within the scope of this invention and its protection. Those skilled in the art should understand that this specification and its accompanying drawings are illustrative and do not constitute a limitation on the claims. The scope of protection of this invention is defined by the claims and their equivalents. This specification contains multiple inventive concepts; terms such as "preferredly," "according to a preferred embodiment," or "optionally" indicate that the corresponding paragraph discloses an independent concept. The applicant reserves the right to file divisional applications based on each inventive concept. Throughout the text, features introduced by "preferredly" are merely optional and should not be construed as mandatory. Therefore, the applicant reserves the right to abandon or delete relevant preferred features at any time.

Claims

1. An evaluation system for medical dressings, comprising: A suction unit (100) is used to provide negative pressure to at least the medical dressing (500). Acquisition unit (200) is used to acquire optical information of the patient's wound area. Detection unit (300) is used to perform optical detection and / or electrochemical detection methods. Processing unit (400) is used to receive and process signals containing data information transmitted by the acquisition unit (200) and the detection unit (300). Its features are, The suction unit (100), which is connected to the medical dressing (500) covering the patient's wound, can transmit negative pressure to the medical dressing (500) and pump wound exudate out of the medical dressing (500) in the form of fluid. The processing unit (400) infers the dressing state and wound state in the current time series based on the detection results obtained by detecting wound exudate by one or more detection components in the detection unit (300), and compares the dressing state and wound state in the current time series with the dressing state and wound state in the previous time series, respectively. When it is determined that the dressing state is decreasing at an accelerated rate, the preset time period of the acquisition unit (200) is adjusted so that the preset time period is gradually shortened. The start of the acquisition unit (200) is at least automatically controlled based on the preset time period and / or manually controlled based on the switching of the treatment program. The optical information acquired by starting the acquisition unit (200) includes at least wound-related image information and dressing-related image information.

2. The evaluation system according to claim 1, characterized in that, The acquisition unit (200) acquires optical information of the patient's wound area without directly contacting the medical dressing (500) and / or the wound, so that the processing unit (400) can analyze the external state of the medical dressing (500) and / or the wound, wherein the processing unit (400) also evaluates the medical dressing (500) and / or the wound based at least on the detection results of the detection unit (300).

3. The evaluation system according to claim 1, characterized in that, The suction pump (110) of the suction unit (100) is connected directly or indirectly to the medical dressing (500) through the suction container (130) via the suction line (120). The suction line (120) connected to the input end of the suction container (130) is equipped with a valve (140) whose opening and closing degree is controlled by the processing unit (400).

4. The evaluation system according to claim 3, characterized in that, The processing unit (400) controls the valve (140) to introduce at least a portion of the wound exudate in the suction line (120) into one or more detection components in the detection unit (300) for detection.

5. The evaluation system according to any one of claims 1 to 4, characterized in that, The first detection component (310) configured in the detection unit (300) can detect the pH of wound exudate by utilizing the different optical properties of pH-sensitive materials under different pH environments. When the optical sensor in the first detection component (310) used to acquire optical information related to the pH-sensitive material is incorporated into the acquisition unit (200), the preset time period for the acquisition unit (200) to start is at least based on the detection results of the second detection component (320) and / or the third detection component (330).

6. The evaluation system according to claim 5, characterized in that, The second detection component (320) is capable of detecting the oxygen concentration in wound exudate using an oxygen-sensitive material, wherein the second detection component (320) is disposed in a suction container (130) or a suction line (120).

7. The evaluation system according to claim 5, characterized in that, The third detection component (330) can introduce labeled antibodies or aptamers to bind to the target in wound exudate, and analyze the conjugate after reaction by optical detection and / or electrochemical detection. The third detection component (330) is configured with a reaction chamber and a detection chamber connected in a controllable on / off manner, and the reaction chamber is set in a position that takes precedence over the detection chamber.

8. The evaluation system according to any one of claims 1 to 4, characterized in that, When the medical dressing (500) is replaced, the evaluation parameters related to wound healing generated by the processing unit (400) based on the optical information collected by the acquisition unit (200) on the open wound can be obtained by comparing the actual amount of wound healing with the predicted amount of wound healing, so as to determine the actual effect of the medical dressing (500) under the current use conditions and corresponding use methods.

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