CN115497640A - Evaluation system and method for medical dressing - Google Patents

Abstract

The invention relates to an evaluation system and a method for a medical dressing, the evaluation system comprises a suction unit, a collection unit, a detection unit and a processing unit, wherein the suction unit communicated with the medical dressing covering a wound of a patient can transmit negative pressure to the medical dressing and pump wound exudate out of the medical dressing in a fluid form, the processing unit adjusts a preset time period for starting the collection unit based on a detection result obtained by one or more detection components in the detection unit for detecting the wound exudate, and the starting of the collection unit is automatically controlled at least based on the preset time period and/or manually controlled based on the switching of a treatment program. The evaluation method employs an evaluation system to determine actual use of medical dressings in a treatment session for different types of wounds to obtain an expected use of any medical dressing for the treatment session for a given type of wound.

Description

Evaluation system and method for medical dressing

Technical Field

The invention relates to the technical field of medical equipment, in particular to an evaluation system and method for a medical dressing.

Background

NPWT (Negative Pressure Wound Therapy) is Negative Pressure Wound Therapy, is an advanced Wound Therapy mode developed in recent years, is different from the traditional Wound nursing and Negative Pressure drainage technology, and mainly adopts a lower Negative Pressure (generally-55 mmHg to-175 mmHg) and an intermittent working mode to treat wounds. Currently, NPWT has been widely used in various acute and chronic wounds including acute soft tissue defects, various chronic (pressure, vascular, diabetic) ulcers, surgical incision dehiscence or infection, and is particularly suitable for various chronic difficult-to-heal wounds where conventional surgical methods are ineffective, and wounds where a definitive surgical wound closure method such as flap transplantation cannot be performed immediately.

The NPWT has definite effect of promoting wound healing, and relates to the comprehensive effects of increasing local blood flow, eliminating local edema, reducing wound exudate accumulation, inhibiting wound bacterial growth, promoting cell proliferation and granulation tissue growth, maintaining the moist environment of the wound and tissues around the wound, regulating collagenase and gelatinase activity, relieving post-wound immunosuppression and the like.

CN111132605a discloses embodiments of an apparatus, system, method for monitoring wound pH. In some embodiments, the wound dressing includes one or more optical sensors configured to measure a color change in the pH-sensitive adhesive that changes color in response to a change in pH of the wound exudate. In some embodiments, the wound dressing may further comprise hydrophilic channels that direct wound exudate to the pH sensitive material on the optical sensor. Such dressings may also be used in combination with negative pressure wound therapy systems.

CN111107814a discloses sensor positioning and optical sensing for sensor-implemented wound therapy dressings and systems. In some embodiments, a wound monitoring and/or therapy apparatus may include a wound dressing configured to be positioned over 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 an optical sensor and a single light source. In some embodiments, the wound dressing may include a substantially stretchable wound contact layer including a wound-facing side configured to be positioned in contact with a wound and a non-wound-facing side opposite the wound-facing side. 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 wound periphery or both.

However, in the prior art, medical dressings for negative pressure wound therapy are rarely able to provide visualization or information of the state of the wound under the dressing. This may require the dressing to be replaced prematurely before a desired level of wound healing has occurred, or for an absorbent dressing, before the full absorbent capacity of the dressing is reached to allow the clinician to check the healing and status of the wound. Even though the prior art provides wound state information by monitoring the wound pH through the pH sensitive material guiding wound exudate to the optical sensor, various factors such as environment, light source, sensor and/or sensitive material all affect the accuracy of the monitoring result, so that the evaluation of the medical dressing and the prediction of wound healing cannot be accurately completed, which may not only cause the medical staff to misjudge the wound state of the patient, but also cause the treatment effect of the patient to be less than expected.

Furthermore, on the one hand, due to the differences in understanding to the person skilled in the art; on the other hand, since the applicant has studied a great deal of literature and patents when making the present invention, but the disclosure is not limited thereto and the details and contents thereof are not listed in detail, it is by no means the present invention has these prior art features, but the present invention has all the features of the prior art, and the applicant reserves the right to increase the related prior art in the background.

Disclosure of Invention

In view of the deficiencies of the prior art, the present invention provides an evaluation system and method for a medical dressing to address at least the above technical problems.

The invention discloses an evaluation system for medical dressings, comprising: the medical dressing comprises a suction unit for providing negative pressure to at least the medical dressing, an acquisition unit for acquiring optical information of a wound area of a patient, a detection unit for performing optical detection and/or electrochemical detection methods, and a processing unit for receiving and processing signals with data information transmitted by the acquisition unit and the detection unit.

The suction unit communicated with the medical dressing covering the wound of the patient can transmit negative pressure to the medical dressing and pump wound exudate out of the medical dressing in a fluid mode, the processing unit adjusts a preset time period for starting the acquisition unit based on a detection result obtained by one or more detection assemblies in the detection unit on the wound exudate, wherein the starting of the acquisition unit is automatically controlled based on at least the preset time period and/or manually controlled based on the switching of a treatment program, and optical information obtained by starting the acquisition unit at least comprises image information related to the wound and image information related to the dressing.

Preferably, the method for closing the open wound surface by the dressing and treating the wound by generating negative pressure after connecting the dressing with the suction pump through the suction pipeline can reduce the pressure around the wound, increase the blood flow in the blood vessel of the wound surface, stimulate the growth of granulation tissues, fully drain exudates, relieve edema, resist infection and accelerate the healing of the wound. Preferably, the acquisition unit may continuously or intermittently acquire image information of the wound area of the patient throughout the wound treatment process, wherein the image information comprises at least image information related to the wound and image information related to the dressing. Further, since the patient cannot guarantee the same posture throughout the wound treatment process, and the acquisition unit cannot adapt to the movement of the patient to complete dynamic following, the acquisition unit may preferably adopt an intermittent acquisition mode and is started at least when the treatment program of the wound treatment process is switched, and the treatment program is switched by the medical staff, wherein the starting of the acquisition unit may 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 automatically controlled to be started based on the preset time period can be used for acquiring images of a wound area of a patient, the wound area of the patient is actively placed in the acquisition area, the processing unit can remind the patient in advance to prepare for acquisition work and guide posture arrangement before the preset time period is reached, and can inform the patient and/or a caregiver and/or a medical worker when the acquisition unit started when the preset time period is reached cannot acquire correct image information from the acquisition area, wherein the reminding, the guiding and/or the informing can be realized in one or more modes of voice, characters, images and videos; the collection unit which is manually controlled to be activated based on the switching of the treatment program can be manually operated by medical staff, wherein the treatment program can roughly comprise a wound period during which the wound is exposed to the external environment and a dressing period during which the wound is covered by the medical dressing, and the switching of the treatment program is switching back and forth between the wound period and the dressing period.

According to a preferred embodiment, the acquisition unit acquires optical information of the wound area of the patient without directly contacting the medical dressing and/or the wound, so that the processing unit can analyze the overt state of the medical dressing and/or the wound, wherein the processing unit further evaluates the medical dressing and/or the wound at least based on the detection result of the detection unit.

Preferably, the overt status refers to status information that is visually accessible from the external environment without direct contact with the dressing and/or wound. Preferably, the wound area of the patient can be an area defined by the position of the wound of the patient and the skin around the wound of the patient, and can also be an area covered by the medical dressing on the wound of the patient. Preferably, the acquisition unit may acquire environmental information such that the processing unit may correct the image information based on an external environment, wherein the environmental information acquired by the acquisition unit may be at least a parameter capable of influencing the image of the wound area of the patient identified by the processing unit, such as an ambient temperature, an ambient light, and the like. Preferably, the acquiring unit may acquire peripheral skin information (e.g., skin color, skin wrinkle, natural discoloration, etc.) of a wound site of the patient when acquiring the image information of the wound area of the patient to establish standard skin data for the patient, which includes at least the skin color in a normal state, wherein the peripheral skin of the wound site of the patient is at least skin without the influence of wound, i.e., corresponds to the normal skin color of the patient. Further, when the image information acquired by the acquisition unit does not contain the relevant information of the peripheral skin, the setting position and/or angle of the acquisition unit can be properly adjusted to ensure the integrity of the image information acquisition.

According to a preferred embodiment, the suction pump of the suction unit communicates with the medical dressing directly or indirectly via a suction line via a suction container, wherein a valve whose opening and closing are controlled by the processing unit is arranged on the suction line connected to the input of the suction container.

According to a preferred embodiment, the processing unit detects by controlling the valve to introduce at least part of the wound exudate in the aspiration line into one or more detection components in the detection unit.

According to a preferred embodiment, the first detection assembly of the detection unit is configured to detect the pH of the wound exudate by using different optical properties of the pH sensitive material under different pH environments, wherein when the optical sensor in the first detection assembly for acquiring optical data 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 obtained based on the detection result of the second detection assembly and/or the third detection assembly.

According to a preferred embodiment, the second detection assembly is capable of detecting the oxygen concentration in the wound exudate by means of an oxygen sensitive material, wherein the second detection assembly is arranged within the suction container or in the suction line.

According to a preferred embodiment, the third detection module is capable of introducing a labeled antibody or aptamer for binding to a target in wound exudate and analyzing the reacted conjugate by means of optical detection and/or electrochemical detection, wherein the third detection module is provided with a reaction chamber and a detection chamber which are connected in a controlled manner, and the rank of the reaction chamber is arranged in preference to the detection chamber.

Preferably, the scheme of negative pressure wound treatment and the detection of the target object can be simultaneously completed through the suction unit, the detection of the target object does not interrupt the maintenance of the negative pressure, the treatment progress is not influenced, and the treatment scheme can be timely improved and adjusted based on the detection result.

According to a preferred embodiment, when the medical dressing is replaced, the evaluation parameter related to wound healing generated by the processing unit based on the optical information acquisition of the open wound by the acquisition unit can be obtained based on the comparison between the actual healing amount and the predicted healing amount of the wound so as to determine the actual using effect of the medical dressing under the current using condition and the corresponding using method.

Preferably, the evaluation parameter related to wound healing is based on a comparison of the actual and predicted healing amount of the wound, wherein the healing amount is characterized by the percentage reduction of the wound area. Preferably, the treatment effect of the dressing of the previous sequence in the previous use process can be evaluated according to the evaluation parameter related to wound healing so as to judge the matching degree of the dressing and the wound symptom of the patient in the previous use process, so that the initial value of the predicted healing amount of the dressing of the next sequence can be adjusted, the healing degree of the wound in the subsequent use process can be more accurately predicted, and particularly, the prediction accuracy of the treatment time and the effect of the whole treatment process can be improved. Preferably, the processing unit may calculate an initial value of the predicted healing amount of the dressing of the next sequence based on the current state of the wound of the patient, and may continuously correct the predicted healing amount according to the detection result obtained by the detection unit, 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 evaluation system.

The invention also discloses an evaluation method for the medical dressing, which adopts the evaluation system to determine the actual use condition of the medical dressing in the treatment work for different types of wounds so as to obtain the expected use condition of any medical dressing for the treatment work of the specified type of wounds, wherein the use condition comprises the use condition, the use mode and/or the use effect.

According to a preferred embodiment, the evaluation method is capable of determining a recommended use condition of any medical dressing, wherein the medical dressing meeting the recommended use condition has an advantage in at least the expected use effect obtained in the treatment work of wounds of the same category, and the advantage is obtained by comparison with all medical dressings which can be obtained under the existing treatment condition.

Drawings

FIG. 1 is a simplified module connection diagram of an evaluation system according to a preferred embodiment of the present invention.

List of reference numerals

100: a suction unit; 110: a suction pump; 120: a suction line; 130: a suction container; 140: a valve; 200: a collection unit; 300: a detection unit; 310: a first detection assembly; 320: a second detection assembly; 330: a third detection assembly; 400: a processing unit; 500: a medical dressing.

Detailed Description

The following detailed description is made with reference to the accompanying drawings.

FIG. 1 is a simplified block diagram of an evaluation system according to a preferred embodiment of the present invention.

Example 1

An evaluation system for a medical dressing 500 is disclosed that can be used in conjunction with one or more medical dressings 500 such that when the medical dressing 500 is applied to a wound of a patient, the evaluation system can acquire the state of the wound and promote healing of the wound through the medical dressing 500.

Preferably, the evaluation system of the present invention can monitor the dressing and the status of the wound during the treatment of the wound on the human or animal body, wherein "wound" in the present invention can refer to any wound on the human or animal body, and any reference to the body in the present invention can refer to the human or animal body; "wound treatment" in the context of the present invention may relate to the prevention or minimization of damage to biological or living tissue, or to the healing of impaired stops.

Preferably, in the present invention a "wound" may include a lesion of living tissue, typically a cut or rupture of the skin, which may be caused by a cut, a blow or other impact. Alternatively, the wound may comprise a chronic wound or an acute wound, wherein an acute wound may be caused by surgery or trauma, which may undergo various stages of healing within a predicted time frame; chronic wounds usually start as acute wounds, which may be converted to chronic wounds due to immune impairment etc. of the patient, when they do not follow the healing phase, thus prolonging recovery time.

Preferably, in the present invention, the "chronic wound" may include, for example: venous ulcer, diabetic ulcer, peripheral artery disease, pressure sore or bullous, and sexual epidermolysis.

Preferably, other wounds in the present invention illustratively include, but are not limited to, abdominal wounds or other large or incisional wounds, which may result from surgery, trauma, sternotomy, fasciotomy, but also from other conditions, dehiscent wounds, acute wounds, chronic wounds, subacute and dehiscent wounds, traumatic wounds, flaps and skin grafts, lacerations, abrasions, contusions, burns, diabetic ulcers, pressure sores, stomas, surgical wounds, traumatic ulcers, venous ulcers and the like.

Preferably, the evaluation system may perform the above-described data acquisition protocol and/or healing therapy protocol using a negative pressure wound therapy approach, wherein the negative pressure wound therapy may be used to treat an open or chronic wound that is too large to spontaneously close or otherwise fail to heal by applying negative pressure to the wound site, which involves placing a cover that is impermeable or semi-permeable to fluids over the wound, which cover may be in sealed connection with patient tissue surrounding the wound, such that a source of negative pressure (e.g., a vacuum pump) in communication with under the cover may create and maintain negative pressure between the cover and the wound.

Preferably, the negative pressure created by the "negative pressure wound therapy" in the present invention maintains a moist and warm environment to facilitate wound healing, and in particular, the pressure gradient created between the wound and the negative pressure source can reduce wound edema; sub-atmospheric pressure may increase blood flow; can reduce inflammatory reaction; the bacterial load can be altered; can clean wound and inhibit bacterial growth.

Preferably, the cover placed over the wound may be a medical dressing 500, in particular a medical dressing 500 that may be suitable for negative pressure wound therapy. The medical dressing 500 can be placed in a manner that forms a sealed cavity over the wound, where over-wound refers to the side of the wound facing the outside environment and does not refer only to an upper location in space.

According to a preferred embodiment, the evaluation system may be configured with the acquisition unit 200 and the processing unit 400 in signal connection with the acquisition unit 200, such that the processing unit 400 may at least receive the optical information (e.g. may be image information) acquired by the acquisition unit 200 for the wound area of the patient, thereby analyzing the overt state of the medical dressing 500 and/or the wound, wherein the overt state refers to state information that may be intuitively acquired from the external environment without direct contact with the medical dressing 500 and/or the wound. Further, the wound area of the patient may be an area defined by the site of the wound of the patient and the skin around the wound, or an area covered by the medical dressing 500 on the wound of the patient.

Preferably, the acquisition unit 200 may acquire environmental information such that the processing unit 400 may correct the image information based on the external environment, wherein the environmental information acquired by the acquisition unit 200 may be at least a parameter capable of influencing the image of the wound area of the patient identified by the processing unit 400, such as ambient temperature, ambient light, etc.

Preferably, the acquiring unit 200 may acquire peripheral skin information (e.g., skin color, skin wrinkle, natural discoloration, etc.) of a wound site of a patient when acquiring image information of a wound area of the patient to establish standard skin data for the patient, which at least includes skin color in a normal state, wherein the peripheral skin of the wound site of the patient is at least skin without wound influence, i.e., corresponds to the normal skin color of the patient. Further, when the image information acquired by the acquisition unit 200 does not include the information related to the peripheral skin, the setting position and/or angle of the acquisition unit 200 may be appropriately adjusted to ensure the integrity of the image information acquisition.

Preferably, the acquisition unit 200 may continuously or intermittently acquire image information of the wound area of the patient throughout the wound treatment process, wherein the image information comprises at least image information related to the wound and image information related to the medical dressing 500. Further, since the patient cannot guarantee the same posture throughout the wound treatment process, and the acquisition unit 200 cannot adapt to the movement of the patient to complete dynamic following, the acquisition unit 200 may preferably adopt an intermittent acquisition mode and is started at least when the treatment program of the wound treatment process is switched, and the treatment program is switched by the medical staff, wherein the starting of the acquisition unit 200 may 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 automatically controlled to be started based on the preset time period can acquire images of a wound area of a patient in which the patient is actively placed in the acquisition area, the processing unit 400 can remind the patient in advance of the preset time period to prepare for acquisition work and guide posture arrangement, and can inform the patient and/or a caregiver and/or a medical care worker when the acquisition unit 200 started up after the preset time period is reached fails to acquire correct image information from the acquisition area, wherein the reminding, the guidance and/or the informing can be realized in one or more modes of voice, text, images and videos; the manually controlled activation of the acquisition unit 200 based on the switching of the treatment program, i.e. the switching back and forth between the wound phase and the dressing phase, may be performed manually by the medical staff, wherein the treatment program may substantially comprise a wound phase in which the wound is exposed to the external environment and a dressing phase in which the wound is covered by the medical dressing 500.

Preferably, in a first switching procedure from the wound stage to the dressing stage, a fresh medical dressing 500, which has not been used, will be covered over the wound; in the second switching procedure from the dressing period to the wound period, the used old medical dressing 500 is removed from the wound, wherein "new" and "old" of the medical dressing 500 only refer to the usage status and the usage order sequence, and the old medical dressing 500 in the previous order sequence is replaced by the new medical dressing 500 in the next order sequence after being used, which does not represent the old medical dressing 500 in the production date or the factory date, but the medical dressing 500 in the production date or the factory date earlier can be preferentially arranged in the earlier order sequence. Further, the medical staff may activate the collection unit 200 to collect the exposed wound or covered medical dressing 500 in a manually controlled manner before and after completing the first switching procedure and/or the second switching procedure.

Preferably, before the first switching procedure is executed, the image information of the current wound and the surrounding skin can be acquired through the acquisition unit 200 to judge the current wound state, and after the first switching procedure is executed, the image information of the area covered by the medical dressing 500 can be acquired through the acquisition unit 200 to judge the adhesion position and the adhesion condition of the medical dressing 500; before the second switching procedure is performed, the image information of the area covered by the medical dressing 500 may be acquired by the acquisition unit 200 to determine the current cleanness and/or integrity (e.g., the peeling degree of the medical dressing 500) of the medical dressing 500, and after the second switching procedure is performed, the image information of the current wound (e.g., the dry state of the wound) and the surrounding skin may be acquired by the acquisition unit 200 to determine the healing degree of the wound after the treatment period corresponding to one bit sequence of the medical dressing 500, so that the subsequent treatment protocol may be adjusted in time and the healing condition of the wound may be predicted.

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

Illustratively, if the image information acquired by the acquisition unit 200 shows that the color of the wound area of the patient is too white compared to the skin color in the normal state, or 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 medical dressing 500 is not properly set (e.g., the dressing is too tight) in the first switching procedure, and the processing unit 400 may prompt the medical staff to adjust in time.

According to a preferred embodiment, the medical dressing 500 arranged on a wound of a patient is sealably connected to the suction unit 100 of the evaluation system, the suction unit 100 comprising at least a suction pump 110 which can be a source of negative pressure and a suction line 120 which can be connected at both ends to the medical dressing 500 and the suction pump 110, respectively, wherein a first end of the suction line 120 is in communication with the medical dressing 500 and a second end of the suction line 120 is in communication with 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. The method of closing an open wound surface by the medical dressing 500, and generating negative pressure to treat the wound by connecting the medical dressing 500 with the suction pump 110 through the suction pipeline 120 can reduce the pressure around the wound, increase the blood flow in the blood vessel of the wound surface, stimulate the growth of granulation tissue, fully drain exudate, reduce edema, resist infection and accelerate the healing of the wound.

Preferably, in the present invention, the reduced pressure or negative pressure (which may be expressed as, for example, -X mmHg, where X is a numerical value) represents a pressure level with respect to a normal ambient atmospheric pressure (760 mmHg). Therefore, the negative pressure value-X mmHg means an absolute pressure lower than 760mmHg by X mmHg, in other words, reflects the absolute pressure (760-X) mmHg.

Preferably, in the present invention, the negative pressure provided by the suction pump 110 may range from about-20 mmHg to about-200 mmHg.

Preferably, the suction unit 100 may further be configured with a suction container 130 for temporarily containing wound exudate such that an input end and an output end of the suction container 130 may be communicated with the medical dressing 500 and the suction pump 110, respectively, through the suction lines 120 at both sides to introduce the wound exudate into the suction container 130 when the suction pump 110 generates a suction force, wherein the suction line 120 connected to the input end of the suction container 130 may be configured with a valve 140 controlled by the processing unit 400 to adjust an introduction amount of the wound exudate.

According to a preferred embodiment, the evaluation system may be configured with a detection unit 300 for at least the wound exudate analysis, wherein the detection unit 300 may be configured with several detection components depending on the detection target.

Preferably, the detection unit 300 may be configured with a first detection member 310 for detecting pH, and the first detection member 310 may be mixed in the wound exudate with any existing pH sensitive material to change to a specific color or provide a suitable indicator to detect a color change of the pH sensitive material by an optical sensor.

Alternatively, the pH sensitive material may include: pH sensitive dyes, pH sensitive pigments, pH sensitive inks, pH sensitive superabsorbents, pH sensitive adhesive or non-adhesive gels, pH sensitive adhesive or non-adhesive foams, pH sensitive hydrophilic polymers, pH sensitive hydrophobic polymers or other similar materials, among others, such as polyurethane gel matrices.

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

Preferably, different types of pH sensitive materials may exhibit different colors under different pH conditions, and a portion of the pH sensitive materials may further comprise a color change gradient, i.e., the color or chromaticity of the pH sensitive material may be obtained by an optical sensor. Further, the selection of a particular pH sensitive material may result in greater resolution over a narrow pH range associated with a wound, where the pH of the wound may indicate both the healing status of the wound and the presence of other wound conditions such as infection.

Preferably, the optical sensor of the first sensing assembly 310 may be incorporated into the medical dressing 500 to directly acquire optical data information associated with the pH sensitive material, or may be provided as an external device without being incorporated into the medical dressing 500. Further, an optical sensor configured in the manner of an external device may be incorporated into the acquisition unit 200 to acquire optical data information through the acquisition unit 200, wherein the preset time period of the acquisition unit 200 configured in the manner described above related to the start-up is flexibly adjustable, and the adjustment manner is determined based on the detection data acquired by other detection components.

Preferably, the detection unit 300 may be configured with a second detection assembly 320 for detecting oxygen concentration, and the second detection assembly 320 may be activated under appropriate lighting conditions by mixing any existing oxygen sensitive material in the wound exudate to determine an indicator of oxygen concentration in the wound environment through the lifetime and strength of the oxygen sensitive material, wherein the oxygen sensitive material may be encapsulated in a microporous bead. Preferably, the second detection assembly 320 may include a light source and an optical sensor, wherein the second detection assembly 320 may be disposed within the suction container 130 or in the suction line 120.

Preferably, the detection unit 300 may be configured with a third detection component 330 for detecting a target, wherein the target may be, for example, a pro-inflammatory cytokine and/or a protease, etc. Inflammatory cytokines are a group of endogenous polypeptides produced mainly by cells of the immune system and having many powerful biological effects, mediating various immune responses, which have the effect of promoting disease progression; in contrast, anti-inflammatory cytokines have certain cytokines that inhibit the biological effects of the inflammatory response. Such as IL-1Ra and IL-10, play an important role in controlling the inflammatory response and the magnitude of the immune response. A protease is any enzyme that performs proteolysis, i.e. a class of enzymes that hydrolyses peptide chains of proteins.

Preferably, the target substance may comprise a Basic Metabolome (BMP) such as glucose, calcium, sodium, potassium, carbon dioxide and/or chloride, may also comprise a matrix metalloproteinase, and may also comprise a bone morphogenetic protein.

Preferably, the third detecting member 330 can introduce a relatively small amount of wound exudate by using the valve 140, and can introduce a labeled antibody or aptamer to bind to a target in the wound exudate, and the reacted conjugate can be analyzed by an optical detecting method and/or an electrochemical detecting method. Preferably, the third detection assembly 330 may be configured with a reaction chamber and a detection chamber connected in a controlled on-off manner, wherein the order of the reaction chamber is set in preference to the detection chamber, such that wound exudate introduced from the aspiration catheter may first enter the reaction chamber and bind with labeled antibodies or aptamers added to the reaction chamber, and the conjugates are introduced into the detection chamber after the reaction is completed. Further, the analyte-completed conjugate in the detection compartment may be directed downstream of the aspiration conduit, wherein the conjugate may be directed, for example, to temporary storage within the aspiration container 130. The arrangement can enable the scheme of negative pressure wound therapy and the detection of the target object to be simultaneously completed through the suction unit 100, the detection of the target object does not interrupt the maintenance of the negative pressure, the progress of the therapy is not affected, and the therapy scheme can be timely improved and adjusted based on the detection result.

Preferably, a plurality of microfluidic channels are arranged in the reaction chamber and the detection chamber, wherein the microfluidic channels in the detection chamber directly correspond to and are communicated with the microfluidic channels in the reaction chamber. Preferably, each microfluidic channel in the reaction chamber can be introduced with the labeled antibody or aptamer in advance in a non-overflowing manner, wherein the microfluidic channel in the reaction chamber can be provided with a microfluidic switch for switching the microfluidic channel. Preferably, a resin is arranged between the microfluidic channel and the microfluidic switch, and the resin can absorb water and swell when contacting wound exudate so as to push the microfluidic switch to drive the pad connected with the microfluidic switch to move and close the current microfluidic channel, and then the resin continuously moves along with the pad and contacts the next sequence of microfluidic channels, so that the next sequence of microfluidic channels is opened to complete automatic switching of the channels.

According to a preferred embodiment, the processing unit 400 may estimate the dressing state and the wound state at the current time series based on the detection data acquired by the detection unit 300, and may compare the dressing state and the wound state at the current time series with the dressing state and the wound state at the previous time series, respectively, to determine the degree of change. Preferably, when the dressing state is judged to be in a tendency of decreasing in an accelerating manner, the preset time period for controlling the starting of the collecting unit 200 may be set in a gradually shortened manner, that is, the preset time period is a variable non-fixed period, and the setting is based on the detection data obtained by the detecting unit 300. Based on the shortened preset time period, the acquisition unit 200 can acquire the image information of the wound area of the patient from the outside at a relatively higher frequency so as to realize the calibration of the internal and external states of the medical dressing 500, wherein the calibration mode at least needs to refer to the time that the medical dressing 500 is put into use. Further, the preset time period may be reset when the previous sequence of medical dressings 500 is replaced with the next sequence of medical dressings 500, wherein the reset data may be determined based on the length of time the previous sequence of medical dressings 500 was used and the degree of healing of the wound during use.

According to a preferred embodiment, when the medical dressing 500 of the previous sequence is replaced, the acquisition unit 200 may perform optical information acquisition on the open wound (the wound exposed to the external environment) to collect light of a specified wavelength reflected from the wound area of the patient, so that the processing unit 400 may generate an image having a plurality of pixels based on the data signal with optical information transmitted by the acquisition unit 200. Preferably, the specified wavelength may 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 may determine one or more feature vectors from the reflected intensity values of each pixel of the subset of the plurality of pixels at the specified wavelength to generate at least one scalar value by a learning algorithm to correspond to the assessed parameter related to wound healing over the set period of time. Preferably, the learning algorithm may comprise a set of random forests or a set of classifiers.

Preferably, the at least one scalar value may comprise a plurality of scalar values, each scalar value of the plurality of scalar values corresponding to a probability of healing of a respective pixel of the subset or a subset of the respective pixels of the subset.

Preferably, the processing unit 400 can also output a plurality of scalar value visual information to be displayed to a user (e.g., a medical staff) in a visual manner. Further, the visual information may include displaying an image of each pixel of the subset according to particular visual information selected according to the healing probability corresponding to that pixel, wherein pixels associated with different healing probabilities can be displayed with different visual information.

Preferably, the processing unit 400 may automatically divide the plurality of pixels in the generated image into the wound-related pixels and the non-wound-related pixels by a segmentation algorithm, such as a convolutional neural network, wherein the non-wound-related pixels may include one or more of the wound-healing-related pixels, the peripheral normal-skin-related pixels, and the background-related pixels. Preferably, the segmentation algorithm of the convolutional neural network may include at least one of a U-Net comprising a plurality of convolutional layers and a SegNet comprising a plurality of convolutional layers.

Preferably, the evaluation parameter related to wound healing is based on a comparison of the actual and predicted healing amount of the wound, wherein the healing amount is characterized by the percentage reduction of the wound area. Preferably, the treatment effect of the medical dressing 500 of the previous sequence in the previous use process can be evaluated according to the evaluation parameters related to the wound healing to judge the matching degree of the medical dressing 500 and the wound symptoms of the patient in the previous use process, so that the initial value of the predicted healing amount of the medical dressing 500 of the next sequence can be adjusted, the healing degree of the wound in the subsequent use process can be more accurately predicted, and particularly, the prediction accuracy of the treatment time and effect of the whole treatment process can be improved. Preferably, the processing unit 400 may estimate an initial value of the predicted healing amount of the medical dressing 500 of the next sequence based on the current state of the wound of the patient, and may continuously correct the predicted healing amount according to the detection result 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 evaluation system.

Preferably, based on the change of the wound area, the processing unit 400 may prompt the medical staff to adjust the covering position and/or area of the medical dressing 500 at the time of replacing the medical dressing 500 of the subsequent turn, wherein when the first switching procedure of the turn is completed, the acquisition unit 200 may perform image acquisition on the covering position and/or area of the medical dressing 500 to check the reasonableness of the setting of the new medical dressing 500.

According to a preferred embodiment, the evaluation system may be configured with a transmission unit in communication connection with the cloud end to upload the usage and treatment effects of the type of medical dressing 500 of the patient during the current wound treatment process, so as to construct a cloud database, wherein the basic information of the patient, the chief complaint, and the diagnosis results of the medical staff are uploaded together, so that the wound treatment processes with the same symptoms can be classified into the same category by the cloud end. When a user (generally, a medical staff) faces a new patient to perform wound treatment, the data related to multiple groups of wound treatment processes with the same category of symptoms can be downloaded through the cloud end to compare and obtain the usage process and the treatment effect of the medical dressing 500, so as to determine the relevant settings of the wound treatment processes to be performed, for example, the selection of the pH sensitive material, the selection of the oxygen sensitive material, the selection of the labeled antibody or aptamer, and/or the initial value of the preset time period which can be automatically started by the acquisition unit 200 and is calculated by the cloud end big data.

Example 2

This embodiment is a further improvement of embodiment 1, and repeated contents are not described again.

The invention also discloses an evaluation method for the medical dressing 500, which can adopt any one of the evaluation systems described in embodiment 1 to determine the actual use condition of the medical dressing 500 in the treatment work for different types of wounds so as to obtain the expected use condition, the corresponding expected use mode and the expected use effect which can be obtained for different patients of any one of the medical dressings 500, thereby facilitating medical staff to match the most suitable medical dressing 500 from the medical dressings 500 which accord with the expected use condition in the cloud end when facing the treatment work for the same type of wounds, and taking the expected use mode as the suggestion to execute. In other words, the evaluation method may determine recommended use conditions for any medical dressing 500, wherein the expected use effect that may be obtained with a medical dressing 500 meeting the recommended use conditions at least during treatment work for the same type of wound has an advantage that is compared with all medical dressings 500 available under existing treatment conditions.

Preferably, the usage of any medical dressing 500 in the treatment work for different types of wounds can be uploaded by the evaluation system to the cloud in real time for real diagnosis and treatment results and/or for the early entry of experimental data, wherein the usage includes usage conditions and/or usage patterns and/or usage effects.

Preferably, the evaluation method of the present invention can be used to evaluate medical dressings 500 of unknown use, such as newly developed medical dressings 500. Preferably, the assessment method of the present invention can be used to assess medical dressings 500 for particular conditions, such as newly discovered wound categories.

It should be noted that the above-mentioned embodiments are exemplary, and that those skilled in the art, having benefit of the present disclosure, may devise various arrangements that are within the scope of the present disclosure and that fall within the scope of the invention. It should be understood by those skilled in the art that the present specification and figures are illustrative only and are not intended to be limiting on the claims. The scope of the invention is defined by the claims and their equivalents. The present description contains several inventive concepts, such as "preferably", "according to a preferred embodiment" or "optionally", each indicating that the respective paragraph discloses a separate concept, the applicant reserves the right to submit divisional applications according to each inventive concept. Throughout this document, the features referred to as "preferably" are only an optional feature and should not be understood as necessarily requiring that such applicant reserves the right to disclaim or delete the associated preferred feature at any time.

Claims (10)

1. An evaluation system for a medical dressing, comprising:

a suction unit (100) for providing at least a negative pressure to the medical dressing (500),

an acquisition unit (200) for acquiring optical information of a wound area of a patient,

a detection unit (300) for performing an optical detection and/or an electrochemical detection method,

a processing unit (400) for receiving and processing the signals with data information transmitted by the acquisition unit (200) and the detection unit (300),

it is characterized in that the preparation method is characterized in that,

the suction unit (100) communicating with the medical dressing (500) covering the wound of a patient is capable of transmitting a negative pressure to the medical dressing (500) and pumping wound exudate out of the medical dressing (500) in the form of a fluid, the processing unit (400) adjusts a preset time period for activation of the acquisition unit (200) based on detection results of wound exudate detection by one or more detection components in the detection unit (300), wherein activation of the acquisition unit (200) is controlled automatically at least based on the preset time period and/or manually based on switching of a treatment program, and optical information acquired by activating the acquisition unit (200) comprises at least image information related to the wound and image information related to the dressing.

2. The evaluation system according to claim 1, wherein the acquisition unit (200) acquires optical information of a wound area of a patient without directly contacting the medical dressing (500) and/or a wound to enable the processing unit (400) to analyze an overt status of the medical dressing (500) and/or a wound, wherein the processing unit (400) evaluates the medical dressing (500) and/or a wound at least further based on the detection result of the detection unit (300).

3. The evaluation system according to claim 1 or 2, characterized in that the suction pump (110) of the suction unit (100) communicates with the medical dressing (500) directly or indirectly via a suction container (130) by means of a suction line (120), wherein the suction line (120) connected to the input of the suction container (130) is provided with a valve (140) whose opening and closing degree is controlled by the processing unit (400).

4. The evaluation system according to any one of claims 1 to 3, wherein the processing unit (400) detects by controlling the valve (140) to introduce at least part of the wound exudate in the aspiration line (120) into one or more detection components in the detection unit (300).

5. The evaluation system according to any one of claims 1 to 4, wherein the detection unit (300) is configured with a first detection assembly (310) capable of detecting the pH of the wound exudate by using different optical properties of pH sensitive materials under different pH environments, wherein when an optical sensor in the first detection assembly (310) for acquiring optical data information related to the pH sensitive materials is incorporated into the acquisition unit (200), the preset time period for the activation of the acquisition unit (200) is at least based on the detection results of the second detection assembly (320) and/or the third detection assembly (330).

6. The evaluation system according to any one of claims 1 to 5, wherein the second detection assembly (320) is capable of detecting the oxygen concentration in wound exudate by means of an oxygen sensitive material, wherein the second detection assembly (320) is arranged within the suction container (130) or in the suction line (120).

7. The assessment system according to any one of claims 1 to 6, wherein the third detection member (330) is capable of introducing a labeled antibody or aptamer for binding to a target in wound exudate, and analyzing the reacted conjugate by means of optical detection and/or electrochemical detection, wherein the third detection member (330) is provided with a reaction chamber and a detection chamber which are connected in a controlled on-off manner, and the order of the reaction chamber is set in preference to the order of the detection chamber.

8. The evaluation system according to any one of claims 1 to 7, wherein the evaluation parameters related to wound healing generated by the processing unit (400) based on the optical information acquisition of the open wound by the acquisition unit (200) can be obtained based on a comparison of the actual healing amount and the predicted healing amount of the wound when the medical dressing (500) is replaced, so as to determine the actual use effect of the medical dressing (500) under the current use condition and the corresponding use method.

9. An evaluation method for medical dressings, which is characterized in that the evaluation method adopts the evaluation system of any one of claims 1 to 9 to determine the actual use condition of the medical dressings in the treatment work for different types of wounds so as to obtain the expected use condition of any medical dressing for the treatment work of the specified type of wounds, wherein the use condition comprises use conditions, use modes and/or use effects.

10. The assessment method according to claim 9, wherein the assessment method is capable of determining recommended use conditions for any medical dressing, wherein the expected use effect of a medical dressing meeting the recommended use conditions in the treatment work of at least one wound of the same category is superior compared with all medical dressings available under the existing treatment conditions.

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