A monitorable, programmable and safety-enhanced negative pressure wound therapy device for remote treatment and a method of operating said device

Abstract

The invention relates to a device that enables and accelerates wound healing by generating a controlled vacuum used in the healing of chronic and acute wounds and protects the wound area from external effects, and a method for operating said device.

Description

[0001] A MONITORABLE , PROGRAMMABLE AND SAFETY -ENHANCED NEGATIVE PRESSURE WOUND THERAPY DEVICE FOR REMOTE TREATMENTAND A METHOD OF OPERATING SAID DEVICE

[0002] Technical Field

[0003] The invention relates to a device that enables and accelerates wound healing by generating a controlled vacuum used in the healing of chronic and acute wounds and protects the wound area from external ef fects , and a method for operating said device .

[0004] State of the Art

[0005] Negative pressure wound therapy devices basically support the healing process by safely removing harmful fluids from wounds with the vacuum ef fect and by creating physical ef fects that trigger healing in the wound bed with the vacuum ef fect .

[0006] Wound healing i s a complex and dynamic proces s involving a series of cell migrations . This process begins with the removal of debris from the wound environment and continues with infection control , angiogenesis , formation of granulation tissue , contraction and maturation . Over the last century, there have been signi ficant developments in the wound healing process , factors that accelerate healing, and new therapy and care principles . One of these important developments is the method called wound closure with the help of vacuum, which increases the wound healing rate by creating the necessary environment for the wound healing process . In the negative pressure therapy, which is reported to be a promising therapy especially for di f ficult healing and chronic wounds , negative pressure is applied to the wound by using a vacuum device .

[0007] The device generally used in vacuum therapy consists of a disposable waste container attached to the device , a disposable dressing / film that covers the wound, and the tubes that connect this dressing / film to the container in the device . The device creates attraction on the wound with the vacuum it produces . With vacuum, harmful liquids on the wound, i f any, are collected and collected from the tubes into a plastic container .

[0008] The vacuum ef fect is provided by a vacuum motor . This vacuum motor is mostly equipped with a control panel .

[0009] Thanks to this panel , therapy settings can be made according to the patient ' s condition and feedback is provided to the users for the alarms that occur .

[0010] Clinically, only healthcare professionals can decide whether to apply negative pressure wound therapy to a patient , therapy settings , wound dressing and collection container si zes , and therapy duration . In addition, periodic changes in the wound dressing and, i f necessary, changes in the therapy settings of the device can only be made by healthcare professionals .

[0011] For this reason, most of today ' s wound vacuum devices are used in health institutions such as hospitals . However, especially in recent years , home therapy has started to become widespread in order to avoid the hospital costs caused by the therapy and to increase the quality of life of the patient . In this case , the device application to the patient is made by a healthcare professional . The patient can stay at home with the device for a period of time other than changing the wound dressing, updating the therapy settings or eliminating a di f ferent problem .

[0012] There are basically two types of therapy modes in existing negative pressure wound therapy devices . One is Continuous Mode , and the other is Intermittent / Variable Mode . Continuous mode keeps an adj usted vacuum pressure continuously unchanged at that level . In variable mode , the clinician can choose the upper pressure and lower pressure values and the time to apply these pressures . The device also applies the upper and lower pressures determined by the speci fied periods alternately .

[0013] Clinically, continuous mode is mostly used in the initial stages where the wound produces harmful liquids , while variable mode is used to provide stimulation at the wound area when there are no harmful liquids in the wound or after the fluids are very little in amount . Changing the pressure at certain intervals supports the stimulation and blood circulation in the wound area, but it is disadvantageous in terms of removing the fluid from the wound as soon as possible . The reason for this is the lower pressure phase with lower attraction power next to the upper pressure to the target in intermittent / variable mode . Accordingly, it is clinically preferred to switch between these two therapy modes after a certain period of time , especially in the therapy of wounds where wound fluid is abundant .

[0014] After entering the therapy mode and settings on all devices belonging to the current art , the device continues to apply the same mode unless a change is made by the user . In other words , healthcare professionals should intervene in the device after a certain period of time in the therapies they start with continuous mode , terminate the therapy in the existing continuous mode and start a new therapy by making intermittent / variable mode therapy settings . This situation requires the healthcare professional to be able to observe the wound condition continuously, to follow the necessary process for the change of therapy mode , and to be with the patient physically for the change . While this creates an additional workload and risk of error for the healthcare professional , it also creates an additional need for consultation for the patient , and in some cases , it causes the waiver of therapy ef ficiency and the absence of any mode change .

[0015] It is obvious that this situation creates even more risk and workload in cases where the patient continues the therapy at home away from the healthcare professional . Since existing devices cannot switch between therapy modes without requiring additional intervention, they are actually insuf ficient to provide suf ficient solutions for home therapy .

[0016] Negative pressure wound therapy methods can al so have li fethreatening consequences . I f there is any open vein in the wound bed where the application is made or i f there is subsequent bleeding, the patient ' s blood may be collected by the device due to the vacuum applied . Late detection of this situation can cause the patient to lose their li fe . Although the case of bleeding rarely occurs , it is important because of the vital risk it poses when not intervened urgently . It is clear that this risk is much greater in cases where the therapy is performed away from the hospital .

[0017] There are no features to prevent this risk in existing devices . As standard, in the user manuals of the existing devices , the warning "Do not use on open vein or bleeding wounds" is made and the responsibility is completely left to the healthcare professional.

[0018] Negative pressure wound therapy devices give audible and / or visual warning in alarm situations that occur during therapy. These alarms indicate situations where therapy cannot continue until the problem is corrected. Examples of alarms may be air leakage, blockage in tube lines, filling of the collection container, low battery level. Some of the problems that cause alarm can be solved by the patient themselves and some by the healthcare professional themselves if directed correctly. Alarm situations can occur at any time during the therapy. Since the device is connected to the patient throughout the therapy, the alarm warnings should be noticed by the patient, if possible, the problem should be solved by the patient, or the healthcare professional should be informed, and the situation intervened accordingly. On the other hand, this therapy method is mostly applied to the profile of elderly patients (usually due to diabetes, bed sores, wounds caused by circulatory problems and the like) . It can be much more difficult for elderly patients, especially elderly and lonely patients, to notice the alarms given by the device, to examine the relevant technical guidelines and to intervene correctly and to reach the healthcare professional quickly. As a matter of fact, these patients are likely to have different health problems (visual, auditory, physical, etc.) . For this reason, undesirable consequences such as the inability to continue the therapy efficiently or the patient's life risk. It is clear that this risk is much greater in cases where the therapy is performed away from the hospital.

[0019] Current devices present the information that the patient needs to do in the event of an alarm in printed user manuals or digital document archives on websites. In addition, when the alarm goes off, the existing devices give visual (screen icons , LED lights , etc . ) and auditory warnings that can be noticed only by being near the device . This restricts ef fective patient intervention during alarms that create emergency and panic moments or leaves it to the responsibility of the patient to get support from a remote healthcare professional .

[0020] As mentioned above , negative pressure wound therapy devices alarm in certain situations . These alarms are extremely important for the therapy to continue without interruption . In existing devices , there are general types of air leakage alarm, blockage in tube lines , filling of the collection container, low battery level alarms . These alarms indicate the situations that may occur in the device operation, wound dressing and collection container application . However, there is no alarm for user-related problems that may be required in existing devices , especially for therapies continued far from the hospital . For example , since this therapy method can continue for days , there are situations where the patient needs to pause the therapy, such as the need to wash / shower . For this need, the control panels of existing devices have the option to pause the therapy . However, in case of pause , since the active vacuum in the wound bed disappears , after a certain period of time , harmful liquids damage the wound, causing infection to grow and maceration to form on the healthy skin around the wound . These complications are known in clinical data . Therefore , no pauses longer than about 120 minutes should be made during clinical negative pressure wound therapy . This warning is also mentioned in the user manuals of the existing devices . However, despite its known clinical complications , there is no alarm against prolonged therapy pauses in both hospital and remote therapies . Wound dressings and collection containers used in negative pressure wound therapy are of the type of consumables . These products are sterile packaged and may need to be replaced during therapy .

[0021] When the collection containers are full , they must be replaced with new ones . For cases where the collection container is full , the " collection container full" alarm is already present in the existing devices . On the other hand, the wound dressing sets on the wound should be changed periodical ly . Although this range depends on the preference of the physician, there are upper limits according to the material of the dressing . For example , wound dressings containing porous sponges should be changed every 72 hours at most . I f the change is not made , the dressing material loses its physical strength with the vacuum ef fect it is exposed to , causing a gap or obstruction in the wound bed . More importantly, during the therapy, the newly developing living tissues in the wound bed grow into the sponge pores with the ef fect of the vacuum and adhere to the sponge . The longer the sponge dressing remains , the greater the amount of tissue that develops into the pores . After a long time , while this sponge dressing is removed from the wound, it has a traumatic effect on the living tissue in the wound, causing bleeding and worsening wound healing .

[0022] It is the responsibility of the healthcare professional to make timely wound dressing changes in existing devices , and there are warnings only about the maximum residence time in the user manuals . As a result , it creates the workload and risk of making mistakes for healthcare professionals to follow these periods for all their patients . Considering the ongoing therapies away from the hospital , it is clear that the risk o f not performing the workload and changes in a timely manner is much higher . During negative pressure wound therapy, the device component works 24 / 7. The device always tries to keep the pressure in accordance with the therapy settings by actively measuring the vacuum pressure during the therapy. If the device does not work for a reason or if it is paused for a certain period of time, it causes the liquids in the wound to accumulate in the wound bed. In this case, new tissue development in the wound is prevented, the risk of infection increases, and the risk of maceration occurs on the healthy skin around the wound. Therefore, in an ideal therapy process, it is important that the device status is checked regularly by the healthcare professional or by the adequately informed patient. This regular follow-up process creates an additional responsibility and workload in ongoing therapies in the hospital. On the other hand, in ongoing therapies away from the hospital, it becomes more difficult to manage the process, and moreover, it increases the risk of neglect. In addition, in some therapy processes, the therapy settings (target pressure, time intervals, therapy mode, etc.) entered at first are updated by healthcare professionals. For example, in cases of pain complaints due to the shrinkage of the wound or vacuum, the pressure values may be reduced. In this case, it is necessary for the healthcare professional to be with the device.

[0023] Negative pressure wound therapy, like all other medical applications, is open to development and innovation. One of the biggest factors that support development is the efficient collection and evaluation of as much information as possible about existing patient therapies. During a negative pressure wound therapy, many statistical information such as general information of the patient, measured values in the device, alarm situations, wound development over time, wound dressing used, and collection container information emerges. Regular collection of this information and presentation to scientists will contribute to the future of wound therapy . Collecting information will create an additional workload ( daily measurements , filling in records , etc . ) for healthcare professionals , even in the case of ongoing therapy in the hospital , and it will be more di f ficult to obtain this information in ongoing therapies away from the hospital .

[0024] It is understood that the utility model application TR 2021 / 011562 mentions a vacuum wound therapy device used to close the open wound after surgery and to restore the tissue in case of post-accident tissue loss .

[0025] It is understood from the structure of said device that it has an arti ficial intelligence supported camera and an RFID and NFC card reader in order to ensure that only authori zed personnel can access the device . Although the structure is supported by accessories such as cameras , it is understood that the device created is for hospital use rather than home use . It is also thought that it is not possible for said device to operate di f ferent therapy modes on its own without the management of a healthcare professional .

[0026] Said device is not a device that can make remote therapy settings and will contribute to patient safety ( additional alarms , patient guidance ) and healthcare professional workload, especially in remote therapies . In addition, elements such as the communication module and camera image are explained as additional equipment in said device . This situation will require hardware intervention in future updates with device production and maintenance cost . For this reason, i f the structuring subj ect to the application numbered 2021 / 011562 is used, the above-mentioned technical problems continue to exist . Objects of the Invention

[0027] The obj ect of the invention is to create a device that makes wound healing possible by producing vacuum in a controlled way used in the healing of chronic and acute wounds , accelerates and protects the wound area from external influences , increases patient safety and health work ef ficiency, especially in therapies far from the hospital , and the method of operating said device .

[0028] Therefore ,

[0029] - automatically switching treatment modes as clinically required during treatment without the need for additional intervention and consultation,

[0030] - During the therapy, detecting li fe-threatening open vessels and bleeding conditions by the device and warning users , as well as automatic stopping of vacuum to prevent li fe risk,

[0031] - Facilitating the patient to solve the problem correctly and quickly, especially emergency situations experienced in treatments away from the hospital , interactively according to the type of emergency that occurs . Thus , increasing therapy safety and reducing the need for healthcare professional support ,

[0032] - Noti fying healthcare professionals in real time , especially in cases of alarm in therapies far from the hospital . Thus , eliminating the risk of patients with an elderly profile not noticing alarms or not taking the necessary actions ,

[0033] - Detecting long-term treatment interruptions that may occur as a result of user error, especially in treatments away from the hospital , by the device and alarm warning,

[0034] - Eliminating the work follow-up burden and neglect required to change the wound dressings without delay, especially in treatments carried out away from the hospital . Thus , preventing clinical complications that may occur,

[0035] - healthcare professionals ' monitoring the real-time status of the actively operating device , alarm records and other event reports in real time throughout the treatment , especially in treatments that take place away from the hospital ,

[0036] - Automatically collecting treatment data ( device values , wound development process , etc . ) of di f ferent patients and making them processable and reportable in clinical studies .

[0037] Description of the Invention

[0038] The invention relates to a vacuum device that makes wound healing possible by producing vacuum in a controlled way used in the healing of chronic and acute wounds , accelerates and protects the wound area from external influences , comprising the following : a disposable waste container attached to the device , disposable dressing / film that covers the wound, at least one tube connecting this dressing / film to the container in the device and associated with the negative pressure source , and comprising at least one sensor associated with the tube or waste container .

[0039] The vacuum device includes a color sensor apparatus that can be positioned on the tube from the wound with the instrument panel , audio source ( speaker, buz zer, etc . ) , programmable electronic processor card, vacuum motor, pressure sensors , rechargeable battery, Bluetooth or other communication module that communicates with smartphones . The sensor apparatus on the tube is attached to the tube from the outside , does not enter the tube and has a light source with a color sensor on one side . It establishes a wired or wireless connection to the device .

[0040] The sensor in the sensor apparatus detects the color of the liquid in the tube and transmits the measurement values to the processor in the device . The sensor may be plugged into the device by an electrical socket . One end of the apparatus can be configured in the form of a socket that can be inserted into the device and the other end can be configured as a sensor and card box that wraps the tube carrying the liquid withdrawn from the wound . In this case , the sensor apparatus may include the battery in the device as an energy source , optionally the sensor apparatus box may include a rechargeable battery with an independent operation and wireless communication module . In this case , the sensor measurements may be transmitted to the device without requiring a cable and socket .

[0041] The device can be operated like all other devices without this sensor apparatus or wireless communication . The feature of being an independent apparatus is to allow the device to be operated with or without a sensor . Again, the modular structure of the sensor may be added to the existing devices and operated .

[0042] The sensor part , according to one of the embodiments of the invention, can be formed by at least one light LED and at least one photonic color sensor . Within this embodiment , the measurement can be made over a single sensor, and the readings can be transmitted to the processor module . There is a light source positioned on the same side as the sensor so that the measurements are not af fected by the light state of the environment and are possible in the dark . Sensor measurements can be taken simultaneously by activating the light source .

[0043] Thanks to the measurements read from the sensor apparatus , the blood rate in the liquid passing through it and how much liquid passes through it are analyzed . For this purpose , the processor compares the liquid ( exudate ) color range , which is normally expected to come from the wound, with the color intensity close to the blood color ( red) .

[0044] As a result of the processing of the color information from the sensor, i f the blood density ( red tone ) is detected, the device gives a "Bleeding Alarm" visually and audibly . It also automatically pauses the therapy by stopping the vacuum motor to eliminate the li fe risk . In this way, detection and a new type of alarm are provided against the li fe-threatening bleeding situation that is not present in existing devices .

[0045] According to clinical data, it is known that the continuous mode is ef fective for the drainage of liquids at the stage where a greater amount of liquid comes from the wound . On the other hand, it is known that the variable / intermittent mode is ef fective in stimulating wound healing and increasing circulation in the wound area from the stage when the fluid from the wound decreases or ends until the end of the therapy .

[0046] When making settings for a new therapy through the device control panel , the user is of fered three therapy mode options : continuous mode , variable / intermittent mode and inventive adaptive mode . Adaptive mode is not a new therapy mode or clinical method . It allows the device to start in continuous mode and then automatically switch to variable / intermittent mode (without requiring additional intervention) . It ensures that two known therapy modes are performed consecutively according to clinical requirements .

[0047] When the user selects the adaptive mode , they can enter the continuous and variable / intermittent therapy mode settings to be applied consecutively at once before the therapy starts . Accordingly, it is basically ensured that the target pressure value for continuous mode and the upper pressure , upper pressure time , lower pressure , lower pressure time values are entered for variable / intermittent mode . During the therapy process , the user is given two options regarding when to switch from continuous / variable mode to variable / intermittent mode .

[0048] The first of these is that the continuous mode duration can be determined by the user . In this case , at the end of the time entered by the user after the therapy has started, the device automatically switches the therapy mode to the variable / intermittent mode at the speci fied settings .

[0049] In the second option, unlike the first option, the user does not speci fy any time for switching between therapy modes . The device automatically performs this change by analyzing the sensor data on the liquid tube from the wound . When the data from said sensor detects that the fluid from the wound decreases for more than a while with the pattern control of time frequency and color tone , it automatically switches the therapy mode from continuous mode to variable / intermittent mode .

[0050] Thus , clinical ef ficiency is achieved by switching between therapy modes without requiring additional intervention in both adaptive mode options . The sensor may be formed in the form of a drip sensor on the tube connecting the wound to the device . In this way, whether there is liquid in the tube from the wound can be ensured with the drip sensor in the sensor apparatus .

[0051] It is known that pausing negative pressure wound therapies for a certain period of time leads to serious complications . The device has an additional therapy pause upper l imit setting that is not available on existing devices . This setting can be entered by the healthcare professional before or during therapy . When no setting is entered, a standard value is found in the device , for example 120 minutes . I f the therapy is paused by the user ( for washing, showering, radiology shots and similar reasons ) , the device starts a pause counter . It will provide audible and visual alerts when the pause period exceeds the time determined by the healthcare professional .

[0052] On the device control panel , there is an option where the time remaining for the next dressing change is entered by the healthcare professional . I f the user speci fies a time here, the device starts a time counter between the beginning of the first therapy and all subsequent dressing change operations . I f the time counter is close to the speci fied time , an audible and visual warning is given to the dressing change with the remaining time information . Then, i f the meter exceeds the speci fied time , the dressing change alarm is given audibly and visually . On the therapy screen, there are two additional procedures that are not available on existing devices for healthcare professionals . One of them is the wound dressing change recording and the other is the collection container change recording features . When each new wound dressing change is recorded, the device also allows the user to redefine the time remaining for the next dressing change i f desired . Thus , both at the settings at the beginning of the therapy and at each change of dressing, the healthcare professional can reprogram this period according to the conditions.

[0053] In the system components, in addition to the device, there is a "patient application" installed on the patient's smart device (may be a phone, tablet, etc.) , a "healthcare professional application" installed on the smart device of the healthcare professionals responsible for the patient, and a server structure. Patient and healthcare professional applications may still operate continuously in the background with permissions granted on smart devices.

[0054] The device is equipped with a module that allows wireless communication with the patient application (for example, Bluetooth) . The device and patient application are securely paired (with methods such as QR code scanning, serial number entry, connection through the device) to ensure that they remain in continuous communication. During therapy, the device transfers all data generated in the device, such as therapy status, therapy settings, sensor measurements, alarm and event information, to the patient application in real time.

[0055] The patient app displays all information from the device on the patient's smart device. Thus, the patient can follow all information and past event records on the device of the therapy through the smart device. The patient application includes a digital library with information that the patient will need throughout the therapy (user manual, solution of problems, etc.) . This information may be in different translations according to the patient language and the patient can access this information at any time. However, when an alarm information (for air leakage, tube blockage, low battery, container full, bleeding, long-term therapy pause, dressing change time, device fall status and all other types of alarms ) is received from the device during the therapy, the patient application gives an audible and visual noti fication on the patient smart device as well as an audible and visual warning on the device . In addition to the noti fication, according to the type of the incoming alarm ( leakage , blockage , container full , etc . ) , the patient is automatically directed to the page in the application showing what to do in case of that alarm . Thus , while it is ensured that the alarms that will occur are noticed more easily by all patient profiles , the patient is directed to the solution steps of the problem speci fic to that type of alarm at the time of the alarm . The patient application also includes a feature where the patient can take and record a picture of the wound condition . For this , the camera hardware of the smart device is used without the need for additional hardware and device cost .

[0056] In addition to the above-mentioned functions , the patient application simultaneously transmits the data from the device ( therapy status , alarm and other events , sensor values ) to the server over a network ( internet , local network, etc . ) with a unique identi fication code of the device . The server system records the data from the healthcare professional or patient applications with the time information, including the therapy pictures that the patient can take and upload . For this process , a database may contain a file directory and web API methods that applications can use . Communication between the server and the applications may include secure encryptions and authori zed permissions .

[0057] The healthcare professional application establishes a connection to the server over a network . Healthcare professionals can create a user account , profile , and password through the server . Basically, it ensures that new patient records and device mappings are made , the instant status of the patients whose therapy is ongoing can be monitored, the data of the patients whose therapy is completed can be accessed, and the patients can be followed up in teams among the responsible healthcare professionals . Accordingly, a unique code of the device connected to the patient is recorded on the server with the patient information through the application and the data from the device is matched with the patient throughout the therapy . Multiple patient and therapy registrations can be made . The data of the patients ' therapies becomes visible only in other healthcare professional applications that record and optionally share the data for that patient . By selecting the ongoing patient therapies on the application, instant device status and alarm / event history records can be monitored . In addition, the appl ication gives an audible and visual noti fication for the alarms and events that occur on the devices . Thus , it is ensured that the therapy follow-up di f ficulty and safety risks are reduced, especially in ongoing therapies far from the hospital . In addition, information such as pictures of the wound, wound measurements , and other health data measurements can be taken from the healthcare professional application and added to the patient ' s data on the server chronically .

[0058] A web application that of fers al l or some of the features of the healthcare professional application can also be of fered in addition to the system . In this way, in addition to the smart device , the functions can be carried out through an authori zed entry on a website .

[0059] In an optional application, a limited version of the healthcare professional application can also be installed on the smart device of a relative of that patient . In this limited version, by restricting all other features , only the therapy status of the patient to whom they are close can be monitored and noti fied at times of alarm . Active follow-up of the patient ' s relatives is also ensured, so that both patient safety and the workload of healthcare professionals can be reduced .

[0060] In another optional application, the device connected to the patient can be managed by a healthcare professional application that has access to the patient . By selecting a patient whose therapy is ongoing and who has active communication with the server through the healthcare professional application, it is possible to switch to the menu where settings similar to the control panel on the device are made . Thus , all device settings that the patient should not or cannot do on their own can be updated in real time and without the need for a physical patient interview . Examples of settings that can be made remotely on the device : target pressure and time changes , therapy mode change , therapy stop, pause or resume , changing the device interface language , alarm sensitivity settings , wound dressing change record, collection container change record, etc .

[0061] Thanks to the database , file recording and transaction interfaces on the server, many data of completed therapies are systematically stored . These data include the entered information of the patient profile ( age , gender, health data, origin, etc . ) , device settings used in the therapy, status changes during therapy, alarms , events , therapy duration, wound dressing change times , collection container changes and the amount of fluid collected, chronic development data of the wound (picture , si ze measurements , infection test results , blood values , etc . ) and similar pictures taken over time . The healthcare professional can document the application by automatically generating reports of all recorded information for ongoing or completed therapies . In addition, historical therapy data and chronic changes are evaluated in the statistical analysis menus . For example , it can be seen which outputs are obtained against certain settings and patient profile inputs , how much and what type of negative alarms / events occur . Arti ficial intelligence and machine learning infrastructure are created by scoring the chronic information records (pictures , measurements ) of the wounds . Thus , when the pre-therapy data of new patients are entered, applications can support scienti fic development by making therapy settings and other recommendations .

[0062] The vacuum device includes a color sensor apparatus that can be positioned on the tube from the wound with the instrument panel , audio source ( speaker, buz zer, etc . ) , programmable electronic processor card, vacuum motor, pressure sensors , rechargeable battery, Bluetooth or other communication module that communicates with smartphones . The sensor apparatus on the tube is attached to the tube from the outside , does not enter the tube and has a light source with a color sensor on one side . It establishes a wired or wireless connection to the device .

[0063] Within the di f ferent applications of the invention, device application communication can be made with another wireless technology instead of Bluetooth . Again, the wound fluid sensor can be detected by a free independent battery apparatus without being connected to the device . By adding other sensors to it , it can be applied to the area close to the wound and di f ferent analyses can be performed . With the developments in mobile application technology, the information coming from the device to the patient ' s smart device can be sent directly to the healthcare professional ' s smart device through the server instead of going to the application .

[0064] Within the di f ferent embodiments of the invention, the processing module and / or the central server may be operated depending on an arti ficial intelligence module . Within this application, processing methods can be developed to provide future advice with arti ficial intelligence . Within this application, the wireless communication equipment and mobile application-server infrastructure of the device and the data in other wireless health devices connected to the patient can be integrated into the system . The therapy mode may include the control and change module that allows the therapy mode to be changed in accordance with the data received from the processing module or central server sensor according to one of the preferred embodiments of the invention .

Claims

CLAIMS l . A vacuum device that enables and accelerates wound healing by producing vacuum in a controlled manner used in the healing of chronic and acute wounds and protects the wound area from external influences comprising a disposable waste container attached to the device , a disposable dressing / film that covers the wound, at least one tube connecting this dressing / film to the container in the device and associated with the negative pressure source , and at least one sensor associated with the tube or waste container, characterized in that it comprises a communication module associated with the sensor that trans fers the data measured by the sensor to a processing module created within or outside the device for processing, and a processing module that controls the status of the operation of the device and / or transmits it to a central server located outside the device .2 . The vacuum device according to claim 1 , characterized in that it comprises the sensor formed in the sensor structure .

3. The vacuum device according to claim 2 , characterized in that the withdrawn liquid is collected directly in the waste container by means of a tube without contacting the device and without circulating through the device , and the sensor is positioned on the tube without contacting the liquid flowing through the tube .4 . The vacuum device according to claim 2 , characterized in that it comprises a sensor removably connected to the device .5 . The vacuum device according to claim 4 , characterized in that it comprises a sensor that can be attached to the device with an electrical socket .

6. The vacuum device according to claim 5 , characterized in that it comprises a sensor apparatus , one end of which is configured in the form of a socket that can be plugged into the device , and the other end of which is configured as a sensor and card box that wraps the tube carrying the fluid withdrawn from the wound .7 . The vacuum device according to claim 6 , characterized in that it comprises a card box that can contain the processing module and / or communication module in its structure .8 . The vacuum device according to any one of the preceding claims , characterized in that it comprises a sensor portion formed by at least one light led and at least one photonic color sensor .

9. The vacuum device according to claim 8 , characterized in that it comprises a light source positioned on the same side as the sensor .10 . The vacuum device according to claim 8 , characterized in that it comprises a sensor that can detect the color of the liquid in the tube and transmit the measurement values to the processor in the device and can be attached to the sensor device with an electrical socket .11 . The vacuum device according to claim 8 , characterized in that it comprises a drip sensor in the sensor apparatus for detecting whether there is liquid in the tube coming from the wound .12 . The vacuum device according to claim 9 , characterized in that one end is configured in the form of a socket that can be plugged into the device , and the other end is configured in the form of a sensor and card box that surrounds the hose carrying the fluid withdrawn from the wound .

13. The vacuum device according to claim 9 , characterized in that it comprises a processing module that can process sensor data and alarm when it detects a color close to the bleeding state and can start / pause the treatment .14 . The vacuum device according to claim 1 , characterized in that it comprises a processing unit in the form of an electronic card located on the device and a communication module in the form of a Bluetooth unit .15 . The vacuum device according to claim 1 , characterized in that it comprises a processing module operable in connection with a central server that can interpret the data collected and share it with di f ferent electronic devices and share it with authori zed users such as patients , relatives of patients , healthcare personnel .

16. The vacuum device according to claim 1 , characterized in that it comprises a processing module and / or central server that can be operated depending on an arti ficial intelligence module .17 . The vacuum device according to claim 10 , characterized in that it comprises a treatment mode control and switching module that automatically switches the treatment mode from continuous to intermittent / variable mode i f the data from the sensors is below a certain threshold amount for a certain threshold period of time .18 . The vacuum device according to claim 9 , characterized in that it comprises a color sensor reading from a single side on the tubes connecting the wound to the device .

19. The vacuum device according to claim 9 , characterized in that it comprises a drip sensor on the tubes connecting the wound to the device .20 . A method for operating a vacuum used in the healing of chronic and acute wounds , which enables and accelerates wound healing by producing vacuum in a controlled manner and protects the wound area from external influences ; comprising a disposable waste container attached to the device , a disposable dressing / film that covers the wound, at least one tube connecting this dressing / film to the container in the device and associated with the negative pressure source , and at least one sensor associated with the tube or waste container, characterized in that it compri ses the process steps of a sensor associated with a tube or waste structure to continuously analyzing the fluid drawn from the wound by the sensor, the device ' s automatically changing the treatment mode depending on the state of the fluid being evaluated .21 . The method of operating the vacuum device according to claim 16 , characterized in that it comprises the step of regulating the treatment mode by arti ficial intelligence evaluation of the collected data .22 . The method of operating the vacuum device according to claim 16 , characterized in that it comprises the following process steps ;evaluating the liquid withdrawn from the wound by the sensor and transmitting the readings to the communication module , transmitting the data received from the communication module to the processing module and creating an alarm when the processing module detects color close to bleeding by processing sensor data, transmitting the data to the patient and healthcare worker with the alarm created and the process module pausing the therapy as a security measure .

23. The method for operating the vacuum device according to claim 18 , characterized in that it comprises the following process steps :• operating the processing unit depending on a central server,• the central server interpreting the data it collects and sharing it with di f ferent electronic devices and sharing it with authori zed users such as patients , patient relatives , healthcare personnel .24 . The method of operating the vacuum device according to claim 16 , characterized in that it comprises the process step of automatically switching between the therapy modes without the need for a second intervention under the desired conditions for negative pressure wound therapies initiated with the continuous mode option and desired to continue with the intermittent / variable mode option after a certain period of time .25 . The method for operating the vacuum device according to claim 16 or 20 , characterized in that it comprises the following process steps :• preselecting and saving the settings of the continuous mode therapy to be applied first with the healthcare professional adaptive mode therapy option,• then selecting the setting for when to stop the continuous mode a speci fically for the adaptive mode , and• then selecting the settings for the intermittent / variable mode .

26. The method of operating the vacuum device according to claim 23 , characterized in that it comprises the process steps of the device ' s automatically performing this switch by analyzing sensor data on the fluid hose coming from the wound, without setting a time for switching between treatment modes , and detecting a decrease in fluid from the wound for more than a period of time by pattern checking the data from that sensor for time frequency and hue and spontaneous switching of the treatment mode from continuous / continuous to variable / intermittent27 . The method of operating the vacuum device according to claim 16 , characterized in that it comprises the following process steps :• entering the remaining time for the next dressing change by the healthcare professional ,• i f the user speci fies a time period here , the device will start a timer between the start of the first treatment and all subsequent dressing changes ,• i f the time counter approaches the speci fied time , an audible and visual warning is given with the information of the time remaining for the cover change .28 . The method of operating the vacuum device according to claim 16 , characterized in that it comprises the following process steps :• ensuring that the device and patient application are securely paired and remain in continuous communication,• during the treatment , the device transmits all data generated by the device such as treatment status , treatment settings , sensor measurements , alarm and event information to the patient application in real time ,• displaying all information from the device on the patient ' s smart device .

29. The method for operating the vacuum device according to claim 28 , characterized in that it comprises the process step of providing audio and visual noti fication on the patient smart device in addition to the audio and visual alert on the patient app device when an alarm information is received from the device during treatment and according to the type of the incoming alarm, automatically redirecting the patient to the page in the application that describes what to do in that alarm situation .30 . The method for operating the vacuum device according to claim 28 , characterized in that it comprises the following process steps :• transmitting the data from the device to the server over a network with a unique identi fication code of the device ,• the server system records the data from the patient applications with the time information, including the wound pictures uploaded through the patientapplication,• the healthcare professional ' s application establishing a connection to the server over a network,• performing new patient records and device mappings , monitoring the instant status of the patients whose therapy is ongoing, accessing the data of the patients whose therapy is completed, and dividing the patients among the responsible healthcare professionals .31 . The method for operating the vacuum device according to claim 30 , characterized in that it comprises the following process steps :• creating a unique code of the device connected to the patient and matching the data from the device with the patient throughout the treatment by registering it to the server with patient information via the application,• the data of the patients ' therapies becoming accessible only in the applications of the other healthcare professional who records and optionally shares the data for that patient .