A negative pressure therapy system for diabetic foot

Abstract

This invention relates to a negative pressure treatment system for diabetic foot, comprising: a wound dressing capable of defining a closed space for a wound; a negative pressure unit capable of providing a negative pressure environment for the closed space defined by the wound dressing; and a control unit for adjusting the negative pressure environment of the closed space by sending control signals to the negative pressure unit. The wound dressing is equipped with a data acquisition unit for acquiring microenvironmental parameters of the wound, the acquired microenvironmental parameters being transmitted to the control unit so that the control unit can assess the wound healing status based on the microenvironmental parameters and select an appropriate negative pressure strategy based on the assessment results and parameters. The negative pressure strategy includes multiple modes related to negative pressure intensity and drainage cycle.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a negative pressure therapy system for diabetic foot. Background Technology

[0002] With the increasing number of diabetic patients, diabetic foot has become a common complication. Because its underlying pathogenesis includes peripheral neuropathy and peripheral vascular disease, it often leads to severe, difficult-to-heal wounds. The prolonged wound healing and the patient's declining overall condition greatly increase the risk of infection, which further exacerbates the wound's expansion, making healing extremely difficult. Many patients, despite prolonged treatment, still end up with amputation, sometimes even multiple amputations at different planes.

[0003] Currently, treatments for diabetic foot include medication, surgery, and chronic wound management. In chronic wound management, negative pressure wound therapy (NPWT) is widely used clinically. By applying negative pressure to the wound surface, it promotes angiogenesis and tissue repair, demonstrating good performance in promoting wound healing. However, even though NPWT can accelerate wound recovery, its application to chronic wounds caused by diabetic foot still requires a relatively long treatment period (generally four courses of treatment, each lasting five days, with the need for continued treatment determined based on the results at each stage).

[0004] CN108014381A discloses a wound negative pressure drainage device, including a medical surgical membrane, a connector, a drainage catheter, a tissue fluid reservoir, and a negative pressure generator. The medical surgical membrane has a medical sponge block at its bottom and a drainage hole in the middle. The connector is connected to the top of the drainage hole. The drainage catheter is connected to one side of the connector and a drainage rate controller is connected to the other side of the drainage catheter. The drainage rate controller is connected to a first catheter on the other side, and the tissue fluid reservoir is connected to the bottom of the first catheter.

[0005] CN102935261A discloses a negative pressure drainage device and a negative pressure drainage method. The device includes: a porous dressing layer, multiple support components, a covering film, and a drainage connector, wherein: the covering film covers the porous dressing layer; a gap is provided between the covering film and the porous dressing layer; multiple support components are located within the gap, and one end of each support component is fixed to the covering film, while the other end of each support component contacts the porous dressing layer, such that the gap between the covering film and the porous dressing layer forms a drainage channel; one end of the drainage connector is located within the drainage channel and is connected to the drainage channel, while the other end is located outside the coverage area of ​​the covering film.

[0006] CN111001052A discloses a negative pressure drainage system, including a drainage bottle, a connector, a camera, an alarm module, a wireless communication module, and a smart terminal. The drainage bottle has a drainage inlet, and the connector has a drainage channel. One end of the connector is connected to the drainage inlet, and the other end is connected to the drainage tube. The camera is used to acquire image information from inside the drainage bottle. The flow meter is used to measure the liquid flow rate in the drainage channel. The wireless communication module is used to send the image information and flow rate to the smart terminal. The smart terminal determines whether the drainage tube is blocked based on the image information and flow rate. If blocked, it sends alarm control information to the alarm device via the wireless communication module. The alarm device responds to the alarm control information from the smart terminal.

[0007] In other words, during this lengthy negative pressure therapy process, the patient's wound remains constantly within the sealed environment of the dressing and the negative pressure provided by the device. This means that medical staff cannot monitor wound changes in real time; they can only observe the wound's color or granulation tissue growth to assess the healing progress when changing the dressing. This method of assessment has a significant time lag and relies heavily on the experience of medical staff. To increase the monitoring frequency of the wound, medical staff would have to increase the frequency of dressing changes. For more severe ulcerated feet, frequent dressing removal for monitoring necessitates frequent wound cleaning, which disrupts the wound environment and hinders healing. This not only increases the working hours of medical staff but also exacerbates the patient's pain and psychological stress during the prolonged treatment process.

[0008] In addition, it is necessary to control the negative pressure parameters and cycle during negative pressure therapy. Studies have shown that continuous high negative pressure suction can worsen tissue ischemia and increase patient pain. Continuous low to medium negative pressure or continuous negative pressure followed by short intermittent negative pressure is currently the best choice. This is because alternating positive and negative pressure helps promote the contraction of small blood vessels around the wound, increasing tissue blood perfusion and thus promoting granulation tissue growth. However, the pressure changes in the negative pressure environment during alternation of positive and negative pressure or the on / off switching of negative pressure may also cause traction on the wound, damaging growing tissue and causing discomfort and pain to the patient. In the current clinical treatment of diabetic foot, medical staff switch the negative pressure therapy mode based on the patient's feelings and the wound condition. To ensure accurate matching of the negative pressure therapy mode, medical staff need to continuously and accurately observe and record the recovery of the foot during at least 20 days of treatment. As mentioned above, the way medical staff judge the wound is subjective, which will inevitably affect the accuracy of matching the negative pressure therapy mode with the degree of wound recovery. Choosing a negative pressure therapy mode that is incompatible with the current stage of the wound can not only reduce treatment efficiency but also have the opposite effect. Therefore, there is an urgent need for a negative pressure therapy device that can detect the recovery status of diabetic foot ulcers in a simple, non-invasive manner and automatically select the appropriate negative pressure therapy mode.

[0009] 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

[0010] In view of the shortcomings of the prior art, the present invention provides a negative pressure treatment system for diabetic foot to solve at least some of the above-mentioned technical problems.

[0011] This invention discloses a negative pressure therapy system for diabetic foot, comprising:

[0012] Wound dressings, at the very least, can define and enclose a space for the wound;

[0013] The negative pressure section is capable of providing a negative pressure environment for the enclosed space defined by the wound dressing;

[0014] The control unit is used at least to regulate the negative pressure environment of the enclosed space by sending control signals to the negative pressure unit.

[0015] The wound dressing is equipped with a collection unit for acquiring microenvironmental parameters of the wound. The microenvironmental parameters acquired by the collection unit can be sent to the control unit so that the control unit can evaluate the wound healing status based on the microenvironmental parameters and select an appropriate negative pressure strategy based on the evaluation results and parameters. The negative pressure strategy includes multiple modes related to negative pressure intensity and drainage cycle.

[0016] According to a preferred embodiment, the microenvironmental parameters acquired by the acquisition unit include at least pH value, and the control unit can assess the first healing status of the current wound based on the pH value in the wound microenvironment acquired by the acquisition unit, wherein the first healing status includes at least: a first stage where the pH value is at a first acidity or alkalinity, a second stage where the pH value is at a second acidity or alkalinity, and a third stage where the pH value is at a third acidity or alkalinity.

[0017] According to a preferred embodiment, the control unit can determine the negative pressure strategy of the negative pressure unit based on the first healing status of the current wound, wherein the negative pressure unit in the first mode is configured to a continuous low negative pressure suction mode, the negative pressure unit in the second mode is configured to an intermittent negative pressure suction mode, and the negative pressure unit in the third mode is configured to gradually reduce the negative pressure value to stop the negative pressure input.

[0018] According to a preferred embodiment, when the negative pressure strategy of the negative pressure section switches from the first mode to the second mode, the third mode is executed during a set transition time to facilitate the transition.

[0019] According to a preferred embodiment, the microenvironment parameters acquired by the acquisition unit include at least temperature, and the control unit can assess the second healing status of the current wound based on the temperature in the wound microenvironment acquired by the acquisition unit. The control unit can determine the state corresponding to the second healing status based on the relationship between the temperature difference and the first difference threshold range and / or the trend of the temperature difference in amplitude per unit time.

[0020] According to a preferred embodiment, the microenvironment parameters acquired by the acquisition unit include at least wound image information, wherein, based on the current first healing status and / or second healing status of the wound, the control unit can drive the acquisition unit to acquire wound image information with time tags in a way that flexibly adjusts the sampling frequency.

[0021] According to a preferred embodiment, the control unit is at least able to acquire color information and / or shape information in wound image information by configuring one or more analysis modules, wherein the multiple analysis modules of the control unit can be configured to have different analysis accuracies.

[0022] According to a preferred embodiment, the control unit is at least able to determine the number of analysis modules to be activated and / or the task allocation rules based on the acquisition frequency of the image information acquired by the acquisition unit.

[0023] According to a preferred embodiment, the sampling frequency of the acquisition unit for acquiring wound image information can be configured with multiple levels, wherein the acquisition unit can be configured with levels in at least the following manner: the image information acquired by the acquisition unit at different levels can be analyzed by an analysis module activated according to at least one task allocation rule.

[0024] According to a preferred embodiment, the analysis results acquired by the control unit can be sent to an associated user terminal, wherein the user terminal can communicate with one or more control units and can send control signals to the control units for regulating the negative pressure unit.

[0025] The negative pressure suction system provided by this invention uses an intelligent flexible dressing that can acquire wound temperature and pH value, and judges the degree of wound recovery by jointly measuring the temperature and pH value of the wound microenvironment. During the long process of negative pressure treatment for diabetic foot, it enables a rough assessment of the wound's recovery level. Medical staff can visually observe the wound during necessary dressing changes (e.g., when the dressing is completely soaked with waste liquid or the medication is completely absorbed) to help verify the invention's assessment results, eliminating unnecessary dressing changes for wound observation and reducing unnecessary pain for the patient. Simultaneously, this invention uses temperature fluctuations as an early warning indicator of wound infection, avoiding the time lag and inaccuracy of traditional methods that rely on visually judging wound color. It promptly alerts medical staff to take action in the early stages of infection, preventing serious infection consequences.

[0026] Simultaneously, this invention automatically selects a suitable negative pressure treatment mode based on the assessment of the wound's recovery progress. The first mode is tailored for wounds immediately after debridement or surgery, utilizing a gentler, low-to-medium pressure for negative pressure suction. Continuous suction during the first stage, when infection is most likely, creates a relatively hypoxic, weakly acidic environment, inhibiting the growth of pathogenic microorganisms, especially aerobic bacteria. Continuous drainage also promptly removes wound exudate, including secretions and necrotic material, significantly reducing sources of infection and the culture medium on which bacteria thrive. In the second stage, as the wound stabilizes and the pH gradually rises, the system switches to an intermittent negative pressure suction mode. This increases blood circulation, promptly drains exudate, and provides a relatively stable growth environment for granulation tissue particles, preventing damage to these particles due to continuous negative pressure. In the third stage, when the wound has largely recovered and the pH has returned to normal, negative pressure input is gradually reduced, preventing secondary damage to the wound due to sudden changes in the negative pressure environment. As can be seen, this invention can select the appropriate negative pressure therapy mode based on the wound healing progress, avoiding the need for repeated dressing changes and wound observation, and also preventing slow treatment effectiveness or even regression caused by mismatched negative pressure therapy modes. This not only improves treatment efficiency but also reduces the dual psychological and physiological stress on patients during the long treatment process. Attached Figure Description

[0027] Figure 1 This is a simplified schematic diagram of the module connection relationship of a negative pressure suction system according to a preferred embodiment of the present invention.

[0028] List of reference numerals

[0029] 100: Negative pressure unit; 200: Data acquisition unit; 300: Control unit; 400: User terminal; 500: Wound dressing. Detailed Implementation

[0030] The following is a detailed explanation with reference to the accompanying drawings.

[0031] Figure 1 This is a simplified schematic diagram of the module connection relationship of a negative pressure suction system according to a preferred embodiment of the present invention.

[0032] The present invention provides a negative pressure suction system for diabetic foot, comprising: a negative pressure unit 100 configured to communicate with a wound dressing 500 placed above the wound to provide a negative pressure environment for realizing the closed space defined by the wound dressing 500; a collection unit 200 configured to acquire at least the microenvironment parameters of the wound; and a control unit 300 configured to control at least the negative pressure parameters of the negative pressure unit 100.

[0033] Preferably, the control unit 300 can assess the healing status of the wound based on the microenvironment parameters acquired by the acquisition unit 200, and select a corresponding negative pressure strategy based on the assessment results and the corresponding parameter range. The negative pressure strategy includes at least a variety of negative pressure drainage modes related to negative pressure intensity and drainage cycle.

[0034] Preferably, the microenvironmental parameters acquired by the acquisition unit 200 may include at least one or more of pH value, temperature, and image information. For different microenvironmental parameters, the acquisition unit 200 may be equipped with corresponding detection elements on the wound dressing 500. Furthermore, the detection elements can be arranged on the wound dressing 500 in a multi-directional manner to acquire microenvironmental parameters at different sampling points of the wound (limited by factors such as position, angle, and direction). The microenvironmental parameters of the wound can be obtained by weighted analysis of the local parameters at different sampling points.

[0035] Preferably, the negative pressure section 100 can drain fluid from the wound through a negative pressure drainage tube to promote wound healing.

[0036] According to a preferred embodiment, the control unit 300 can assess the first healing status of the current wound based on the pH value in the wound microenvironment acquired by the acquisition unit 200, wherein the first healing status may include at least: a first stage where the pH value is at a first acidity or alkalinity, a second stage where the pH value is at a second acidity or alkalinity, and a third stage where the pH value is at a third acidity or alkalinity.

[0037] Furthermore, in the initial stage of trauma, the tissues surrounding the wound produce a large amount of lactic acid and other metabolic waste, leading to a decrease in tissue pH. The pH value at this time is typically around 5.0-6.5; this stage is called the inflammatory phase, and it lasts for several days to about a week. With cell repair and regeneration, the tissues around the wound begin to secrete alkaline substances and clear harmful metabolic products such as lactic acid. The pH value gradually rises to above 7.0; this stage is called the proliferative phase, and it typically lasts for several days to about two weeks. Finally, there is the maturation phase, at which point the wound has completely healed, and the pH value gradually stabilizes within the normal range, i.e., between 7.35 and 7.45. Therefore, the aforementioned first pH value is preferably 5.0–6.5, the aforementioned second pH value is preferably 6.5–7.3, and the aforementioned third pH value is preferably 7.35–7.45.

[0038] Preferably, the control unit 300 can determine the first healing status of the wound based on the different stages of the current wound microenvironment, and then determine the negative pressure strategy of the negative pressure unit 100 based on the first healing status. When the wound is in the first stage, the control unit 300 can drive the negative pressure unit 100 to at least adjust to a first mode, which can be configured as a continuous low-to-medium negative pressure suction mode. When the wound is in the second stage, the control unit 300 can drive the negative pressure unit 100 to at least adjust to a second mode, which can be configured as an intermittent negative pressure suction mode, with the time interval optionally set to continuous suction for 5 minutes and intermittent suction for 2 minutes. When the wound is in the third stage, the control unit 300 can drive the negative pressure unit 100 to at least adjust to a third mode, which can be configured as a mode that gradually reduces the negative pressure value to stop the negative pressure input.

[0039] Furthermore, the negative pressure value of the first mode is preferably -125 to -80 mmHg, more preferably -80 mmHg; the negative pressure value of the second mode is preferably -80 to -10 mmHg.

[0040] Typically, as the wound healing process progresses, the wound microenvironment changes roughly in a trend from the first stage to the second stage and then to the third stage. Therefore, the negative pressure unit 100 can be adjusted from the first mode to the second mode and then to the third mode based on the regulation of the control unit 300. Furthermore, to avoid the negative pressure unit 100 causing abrupt changes in the wound microenvironment during the switching between the first and second modes, thereby affecting the wound healing process or causing patient discomfort, the negative pressure unit 100 can transition back to the second mode by executing the third mode. When the third mode is only used as a transition, the transition time when the third mode is activated can be determined based on a system-preset time and / or a time set by medical personnel based on clinical experience. More preferably, the transition time can be set to 10-20 minutes. Preferably, the control unit 300 sets corresponding duration thresholds for at least different modes of the negative pressure unit 100, wherein the duration of the first mode is preferably no more than 48 hours.

[0041] Preferably, the wound healing process does not strictly follow the sequence of the first, second, and third stages. There may be special stages that deviate from the predetermined progress. For example, the duration of a certain stage may exceed a set threshold, and / or fluctuations based on pH monitoring may occur between two adjacent stages, or even the stages may reverse. Therefore, when the wound healing process enters a special stage, the control unit 300 can strengthen the monitoring of the wound healing status within a limited observation period, and at least when the duration of the special stage exceeds the limited observation period and / or when abnormal wound conditions are detected based on the monitoring during the observation period, the negative pressure unit 100 can be switched to the third mode in a timely manner and medical personnel can be notified to intervene promptly.

[0042] According to a preferred embodiment, the control unit 300 can assess the second healing status of the current wound based on the temperature in the wound microenvironment acquired by the acquisition unit 200, wherein the second healing status can be determined at least based on the difference between the acquired temperature value and a set temperature value. Furthermore, the set temperature value can be adjusted at least based on the current stage of the wound corresponding to the first healing status, so as to more accurately assess the second healing status of the wound at different stages.

[0043] Preferably, the control unit 300 can set a first difference threshold range based on the current stage of the wound corresponding to the first healing condition and the corresponding set temperature value. The second healing condition includes at least a first state where the temperature difference is within the first difference threshold range and other states where it is not within the first difference threshold range. These other states may include at least a second state where the temperature difference gradually increases in amplitude per unit time, a third state where the temperature difference gradually decreases in amplitude per unit time, and a fourth state where the temperature difference remains essentially constant in amplitude per unit time. Further, the amplitude per unit time refers to the increase in the difference between the collected temperature value and the set temperature threshold within one unit time, where the difference is taken as an absolute value. In other words, the gradual increase in amplitude per unit time in the second state means that, after sorting the unit time according to the time sequence, the increase in a relatively later unit time within a number of consecutive adjacent time sequences is greater than the increase in a relatively earlier unit time. The gradual decrease in amplitude per unit time in the third state means that, after sorting the unit time according to the time sequence, the increase in a relatively later unit time within a number of consecutive adjacent time sequences is less than the increase in a relatively earlier unit time. Furthermore, the number of consecutive adjacent time series can be at least greater than 2, preferably greater than 3, so that when the increase rate of multiple consecutive adjacent time series fluctuates in each unit time, it can be classified into the fourth state.

[0044] Furthermore, the control unit 300 can also be configured with a second difference threshold range that is different from the first difference threshold range, for determining alarm requirements, wherein the second difference threshold range is greater than the first difference threshold range, so that the second state, the third state and the fourth state in the second healing situation all fall between the first difference threshold range and the second difference threshold range.

[0045] Preferably, the present invention only analyzes the difference between the collected temperature value and the set temperature threshold when there is an increase in the difference within a unit of time, so as to determine the deviation trend of the current wound environment temperature from the set temperature value. Instead of analyzing the difference when there is a decrease, the computational load can be greatly reduced without affecting the monitoring timeliness and accuracy. In particular, the control unit 300 can respond in a timely manner when the difference exceeds the second difference threshold range, especially when the difference exceeds the range or is about to exceed the range.

[0046] Preferably, based on the current first and / or second healing status of the wound, the control unit 300 can drive the acquisition unit 200 to acquire wound image information by flexibly adjusting the sampling frequency, wherein the wound image information includes at least color information and / or shape information. Further, the wound image information sent by the acquisition unit 200 to the control unit 300 is at least accompanied by a time stamp.

[0047] Preferably, the wound image information acquired by the acquisition unit 200 can be sent to the control unit 300 to perform analysis operations. The control unit 300 can acquire color information and / or shape information from the wound image information by configuring at least one or more analysis modules. Further, the analysis module can calculate the actual color of the wound based on the wound color information and determine the analysis results related to the color information by comparing the actual wound color with a preset color table. Further, the analysis module can calculate the wound particle size based on the wound shape information and determine the analysis results related to the shape information by comparing the wound particle size with a preset shape threshold table.

[0048] Furthermore, when the control unit 300 is equipped with multiple analysis modules, the multiple analysis modules can be configured to have different analysis accuracies. Preferably, to save configuration costs, the control unit 300 can be configured with a first analysis module and a second analysis module, which have high and low analysis accuracies respectively. In this case, without additional computing power, for the same image information, the first analysis module usually needs to spend more analysis time than the second analysis module to obtain a relatively higher accuracy analysis result.

[0049] Preferably, the sampling frequency of the acquisition unit 200 for acquiring wound image information can be configured with multiple levels to match the analysis time of the analysis modules. That is, the maximum sampling frequency of the acquisition unit 200 is set at least in a manner that allows the acquired image information to be "digested" by all analysis modules activated according to reasonable task allocation rules. Image information acquired at other sampling frequencies can be "digested" by analysis modules activated according to different task allocation rules. This "digestion" means that the activated analysis modules can smoothly complete the analysis task without changing the calibrated analysis accuracy and analysis speed, without any backlog of image information to be analyzed. Preferably, the acquisition unit 200 can be configured with at least a high-frequency level, a medium-frequency level, and a low-frequency level, wherein the level can be determined by the control unit 300 at least based on the stage corresponding to the first healing condition of the wound. Preferably, in response to the control signal of the control unit 300, the acquisition unit 200 can use high-frequency and / or medium-frequency levels to acquire image information for wounds in the first and second stages, and use medium-frequency and / or low-frequency levels to acquire image information for wounds in the third stage. More preferably, since multiple settings are typically available for wounds at various stages, the control unit 300 can determine the specific setting based on the state corresponding to the second healing stage of the wound. Specifically, at least when the wound is in the second and / or fourth state, the acquisition unit 200 can use a setting with a relatively higher frequency. Furthermore, the acquisition unit 200 can also use a setting with a relatively higher frequency at least when the wound is in a special stage, when the wound is transitioning between regular stages, and / or when the wound is transitioning between regular states.

[0050] Preferably, the control unit 300 can determine the activation status of the analysis modules and the task allocation rules based on the current sampling frequency of the acquisition unit 200 and the single calibration analysis time of each analysis module, so as to ensure the smooth completion of the analysis task while meeting the analysis accuracy requirements. Further, the control unit 300 can collect the analysis results acquired by each analysis module and sort them according to time tags. When a negative result is detected, the control unit 300 can verify the negative result and the analysis module with the highest analysis accuracy corresponding to one or more analysis results with time tags adjacent to the negative result, to determine the reliability of the negative result. This method is particularly suitable for simultaneously activating multiple analysis modules and allocating analysis tasks to analysis modules with different analysis accuracies using either uniform or non-uniform allocation. Uniform allocation involves sequentially allocating the same number of tasks, while non-uniform allocation involves sequentially allocating different numbers of tasks. For example, uniform rotation allocation may involve sequentially assigning an analysis task to the first analysis module and the second analysis module in turn; non-uniform rotation allocation may involve first continuously assigning at least two tasks to one analysis module and then assigning tasks no more than the number of tasks acquired by the aforementioned analysis module to another analysis module.

[0051] Furthermore, when the control unit 300 is configured with multiple analysis modules, the task allocation rules for the activated analysis modules may include at least independent allocation (activating one analysis module), uniform alternating allocation (activating multiple analysis modules), and non-uniform alternating allocation (activating multiple analysis modules). The control unit 300 can determine the number of activated analysis modules and / or the task allocation rules based at least on the acquisition frequency of the image information from the acquisition unit 200. Specifically, the control unit 300 can determine the number of activated analysis modules and / or the task allocation rules based at least on the first and / or second healing stages of the wound. Preferably, when determining the number of activated analysis modules and / or the task allocation rules, the control unit 300 can select a scheme that better matches its analysis accuracy requirements from a variety of reasonable and feasible schemes and / or adjust the task allocation of existing schemes based on its analysis accuracy requirements.

[0052] For example, the acquisition unit 200 may have three frequency levels, and the control unit 300 may have two analysis modules with different analysis accuracies. Image information acquired at the low frequency level can be independently allocated to the second analysis module or non-uniformly allocated to the first and second analysis modules in turn, with the proportion of the second analysis module being greater than that of the first analysis module. Image information acquired at the mid frequency level can be independently allocated to the first analysis module or non-uniformly allocated to the first and second analysis modules in turn, with the proportion of the second analysis module being less than that of the first analysis module. Image information acquired at the high frequency level can be uniformly allocated to the first and second analysis modules in turn.

[0053] This setup is because, for monitoring wound healing, both the sampling frequency of the acquisition unit 200 and the analysis accuracy of the control unit 300 are generally better the higher they are, but it is difficult to satisfy both simultaneously. An excessively fast sampling frequency will generate a large amount of image information to be analyzed. If a relatively higher analysis accuracy is required without improving the hardware and software, it will inevitably lead to a significant increase in analysis time, which may result in a large backlog of image information to be analyzed, affecting the timeliness of the analysis results. Conversely, if the analysis accuracy is reduced in order to ensure the timeliness of the analysis results without improving the hardware and software, it will inevitably affect the accuracy of the analysis results. Furthermore, considering the configuration and usage costs, it is difficult to significantly improve the hardware and software capabilities of the analysis module. Therefore, this invention focuses on balancing sampling frequency and analysis accuracy. Since the sampling frequency is determined based on the first and / or second healing stages of the wound, the balance between sampling frequency and analysis accuracy is not simply a matter of high sampling frequency corresponding to low analysis accuracy (high analysis speed) and low sampling frequency corresponding to high analysis accuracy (low analysis speed). Instead, it requires flexibly adjusting the sampling frequency of the acquisition unit 200 and the activation and task allocation scheme of the analysis module of the control unit 300 according to the real-time situation of the wound. In particular, different acquisition and analysis schemes are required for wounds at different stages and in different states in order to obtain accurate and timely analysis results.

[0054] Preferably, the analysis results can be sent to an associated user terminal 400, which is typically used by the corresponding medical personnel, so that the medical personnel can adjust and / or replace the negative pressure unit 100 and / or wound dressing 500 in a timely manner based on the analysis results. Furthermore, since medical personnel are usually responsible for multiple patients, the user terminal 400 can communicate with the control units 300 of multiple negative pressure therapy systems to obtain information on the wound healing status of different patients under their care. Preferably, the control unit 300 can evaluate the analysis results based on preset indicators to perform adjustment operations on the negative pressure unit 100 according to the optimal matching solution. The control unit 300 can also perform adjustment operations on the negative pressure unit 100 based on control signals sent by the user terminal 400. After performing the adjustment operation, the control unit 300 needs to feed back the adjustment method and adjustment result to the user terminal 400.

[0055] Preferably, the wound microenvironment parameters may change due to the adjustment of the negative pressure unit 100, which may require the acquisition unit 200 and / or control unit 300 to adjust the acquisition frequency and / or the activation of the analysis module and the task allocation scheme according to the changed wound microenvironment parameters.

[0056] According to a preferred embodiment, the control unit 300 may also be configured with a greater number of analysis modules to address situations requiring higher analysis accuracy. For example, for patients with abnormal skin conditions, analysis modules with higher accuracy are needed to recognize image information. Abnormal skin conditions mainly refer to situations where skin conditions are difficult to identify by low-accuracy analysis modules due to factors such as skin pigmentation. This situation is particularly prominent among the elderly. It is estimated that 19.3% of the global population aged 65-99 have diabetes. In China, the incidence of diabetic foot can reach 8.1% among diabetic patients over 50 years of age. Diabetic foot ulcers, as one of the serious complications of diabetic foot, are common in the elderly. Therefore, configuring analysis modules with higher analysis accuracy or increasing the task proportion of analysis modules with relatively higher analysis accuracy can better avoid situations such as obstructed local tissue blood circulation and tissue swelling caused by excessive negative pressure, which can lead to tension blisters that are difficult to detect.

[0057] 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. A negative pressure therapy system for diabetic foot, comprising: a wound dressing defining a closed space for a wound; a negative pressure unit providing a negative pressure environment for the closed space defined by the wound dressing; a control unit for adjusting the negative pressure environment of the closed space by sending a control signal to the negative pressure unit; characterized in that, a collection unit is configured on the wound dressing for acquiring microenvironment parameters of the wound, the microenvironment parameters acquired by the collection unit are sent to the control unit, so that the control unit evaluates the healing condition of the wound based on the microenvironment parameters, and selects a corresponding negative pressure strategy based on the evaluation result and parameters, the negative pressure strategy including multiple modes related to negative pressure intensity and drainage cycle, the microenvironment parameters acquired by the collection unit include pH value, temperature and wound image information, the control unit evaluates the first healing condition of the current wound based on the pH value in the wound microenvironment acquired by the collection unit, the control unit evaluates the second healing condition of the current wound based on the temperature in the wound microenvironment acquired by the collection unit, and the control unit drives the collection unit to acquire wound image information with time label in the form of adjusting sampling frequency based on the first healing condition and / or the second healing condition of the current wound, the control unit determines the negative pressure strategy of the negative pressure unit based on the first healing condition of the current wound, the negative pressure unit in the first mode is configured as a continuous low negative pressure suction mode, the negative pressure unit in the second mode is configured as an intermittent negative pressure suction mode, and the negative pressure unit in the third mode is configured as a mode of gradually reducing the negative pressure value to stop the negative pressure input, the control unit determines the state corresponding to the second healing condition based on the relationship between the temperature difference value and the first difference threshold range and / or the change trend of the temperature difference value with unit time amplitude, the control unit sets the first difference threshold range based on the stage of the current wound corresponding to the first healing condition and the corresponding set temperature threshold value, the second healing condition includes a first state in which the temperature difference value is in the first difference threshold range and other states in which the temperature difference value is not in the first difference threshold range, the other states include a second state in which the temperature difference value gradually increases with unit time amplitude, a third state in which the temperature difference value gradually decreases with unit time amplitude, and a fourth state in which the temperature difference value remains unchanged with unit time amplitude, the unit time amplitude refers to the increment of the difference between the collected temperature value and the set temperature threshold value within a unit time, the control unit is configured with a second difference threshold range for judging the alarm demand, the second difference threshold range is greater than the first difference threshold range, so that the second state, the third state and the fourth state in the second healing condition fall between the first difference threshold range and the second difference threshold range.

2. The system of claim 1, wherein, The first healing condition at least includes: a first stage in which the pH value is in a first acid-base degree, a second stage in which the pH value is in a second acid-base degree, and a third stage in which the pH value is in a third acid-base degree.

3. The system of claim 2, wherein, When the negative pressure strategy of the negative pressure unit (100) is switched from the first mode to the second mode, the third mode is executed for transition within a set transition occupancy time.

4. The system of claim 1, wherein, The control unit (300) can obtain color information and / or shape information in the wound image information by configuring one or more analysis modules. The analysis modules of the control unit (300) can be configured to have different analysis accuracies.

5. The system of claim 4, wherein, The control unit (300) can determine the number of activated analysis modules and / or task allocation rules based on the gear of the image information acquisition frequency of the acquisition unit (200).

6. The system of claim 5, wherein, The sampling frequency of the acquisition unit (200) for obtaining wound image information can be configured with multiple gears. The acquisition unit (200) can be configured in the following manner: the image information obtained by the acquisition unit (200) in different gears can be analyzed by the analysis modules activated according to at least one task allocation rule.

7. The system of claim 6, wherein, The analysis results obtained by the control unit (300) can be sent to the associated user terminal (400). The user terminal (400) can be in communication connection with one or more control units (300) and can send control signals to the control unit (300) to regulate the negative pressure unit (100).

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