TR2021020077A1

TR2021020077A1 - MEASURING, MONITORING AND RECORDING THE INTERNAL ABDOMINAL PRESSURE OF PERITHONEAL DIALYSIS PATIENTS AND WARNING DEVICE IN CASE OF INCREASED PRESSURE

Info

Publication number: TR2021020077A1
Application number: TR2021/020077
Authority: TR
Inventors: Murat İvegen Osman
Original assignee: Murat İvegen Osman
Filing date: 2021-12-15
Publication date: 2023-06-21

Abstract

Mevcut buluş özellikle yeni doğan , prematüre , çocuk ve de yetişkin Periton diyalizi hastalarının karın içi basınç ölçme kayıt etme ve gerektiğinde uyarma cihazı ile ilgilidir. Mevcut buluş özellikle de bugüne kadar elle yapılan ve daimi ölçümü yapılamayan karın içi basınç ölçme kayıt etme verilerini sensörden kablosuz doğrudan kayıt altına alarak kablosuz bir veri tabanında saklayarak doktorun tedavi sürecini izlemesi ve hasta sadakatini gözlemleyebilmesine imkan veren karın içi basıç ölçme kayıt etme cihazı (12) cihazı ve buna ait bir sistemle ilgilidirThe present invention is especially related to a device for measuring, recording and, if necessary, stimulating the intra-abdominal pressure of newborn, premature, child and adult peritoneal dialysis patients. The present invention is an intra-abdominal pressure measurement recording device (12), which allows the doctor to monitor the treatment process and observe patient loyalty by recording intra-abdominal pressure measurement data directly from the sensor and storing it in a wireless database, which has been done manually until now and cannot be measured continuously. relates to the device and a system thereof

Description

TARIFNAME PERITON DIYALIZI HASTALARININ KARIN IÇ BASINCININ ÖLÇÜMÜ , TAKIBI VE KAYIDI VE BASINÇ ARTIMINDA UYARI CIHAZI Bulusun Ilgili Oldugu' Teknik Saha Mevcut bulus Periton Diyalizi hastalarinin karin içi basincinin sürekli ölçümü esasina dayanir. Periton Diyalizi hastalarinin vücutlarina doldurduklari Periton Diyalizi sivisi nedeniyle karin içi basincin sürekli takibi gerektigi durumlarda kullanilmasi çok önemlidir. Özellikle yeni dogan ve küçük yastaki Periton diyalizi tedavisi gören hastalarin kullanimi için tasarlanmistir. Teknigin Bilinen Durumu Mevcut durumda karin içi basinci veya prostat basinci , idrar torbasi basincinin ölçümü hastanin ilgili bölgesinde kullanilmak için üretilen sivinin doldurulup disardan bilinen mekanik gözleme dayali cetvel ile cm su sütunu olarak ölçülür .Bu çok zahmetli ve sürekli yapilabilecek bir durum degildir. Periton diyalizi (PD), hastanin periton bosluguna doldurulan bir diyaliz solüsyonu veya diyalizat kullanarak yarar saglamaktadir. Diyalizat, periton boslugunun periton membrani ile temas eder. Difüzyon ve ozmos degisimleri, peritonel membran boyunca solüsyon ve kan dolasimi arasinda gerçeklesir. Buna bagli olarak, hastanin kan dolasimindaki atik, toksinler ve fazla su, peritonel membrandan diyalizata geçer. Peritonel boslukta tüketilen diyalizat, kandan fazla atiklari, toksinleri ve fazla suyu uzaklastiracak sekilde hastanin karin boslugundan tahliye edilir. Bu döngü gece boyunca tekrarlanabilir, bu durumda otomatik bir diyaliz makinesi kullanilir, zira hasta uyuya kalabilir. Bu döngü gün boyunca da tekrarlanabilir ve bu sistem "sürekli ayaktan periton diyalizi" (SAPD) olarak adlandirilir. Gece yapilan tedaviye de APD Aletli Periton Diyalizi denilir. Sürekli ayaktan periton diyalizi (SAPD), 24 saat devam edebilen bir diyaliz sistemidir. Hastalar diyaliz sirasinda yürüyebilir, uzanabilir ya da çalisabilirler. Bu sistemde yaklasik yetiskinlerde 2 litre , yenidogan veya prematüre bebeklerde 10 ml , çocuklarda 300-500 mililitre diyaliz sivisi peritonyuma periton diyaliz katateri ile infüze edilir. Diyaliz sivisi peritonyum içine bosaltildigi anda diyaliz baslar. Arinma prosesi hastalarin karinlari içerisindeki bu membranda gerçeklesir, istenmeyen maddeler bu süreçte kandan arindirilir. Bu prosese "bekleme süresi" adi verilir. Ardindan kirli diyalizat sivisi karindan bosaltilir ve bu bosaltim süresi yaklasik 20-30 dakika sürer. Bundan sonra, yeni steril sivi yaklasik 6-8 dakika sürecek sekilde karma tekrar yerçekimi ile yüklenir ve bu proses tekrar baslar. Bu döngüler doktorun takdir ettigi ölçüde tüm gün devam Sürekli ayaktan periton diyalizi sivi bosaltiminda saglikli böbrekler kadar basarili degildir. Bu yüzden, proses sirasinda sürdürülmesi gereken bir "kuru agirlik" vardir. Bu agirlikta hastalarin kan basinçlarinin normal seviyede olmasi gerekir ve ne asiri sivi yüklenmesi ne de az sivi yüklenmesi olmalidir. Asiri sivi yüklenmesi kalbin normalden daha zor çalismasina ve yüksek kan basincina sebep olur. Yüksek tansiyon kalici hale geldiginde, kalp üzerinde sürekli bir gerginlige sebep olup kalp krizi riskini arttirabilmektedir. Bu nedenle, arzu edilmeyen kalp hastaliklari riskini azaltmak için, hastanin aldigi ve verdigi sivi miktari sürekli kontrol altinda tutulmasi çok önemlidir. Kalbin fazla zorlanmamasi içinde karin içi basincin belli degerleri ( örnegim 18 cm su sütunu ) asmamasi istenir. Hasatanin barsaklarindaki gaz bile karin içi basincini arttirir bu da kalp için tehlikeli sonuçlar dogurma riski tasir. Özellikle prematüre ve yeni doganlarda , çocuklarda bu basincin takibi çok önemlidir. Bulusumuz bu tip sorunlu hastalarin karin içi basinçlarinin sürekli olarak monitörize edilmesini saglar.APD ( Aletli Periton Diyalizi ) hastalari aksam eve geldiklerinde yatarken kendilerini APD cihazina baglarlar. APD cihazi önceden programlanan süre içinde hastaya dolum yapar , bekler ve bosatim yaparak hacimleri hesaplar. Istenilen miktarda bosaltim yapildiysa ikinci dolum fazina geçer. Bizim sistemimiz de hastanin karim içi basinci sürekli takip edildiginden karin içinde diyaliz nedeniyle artan basinç sürekli takip altinda olup basincin artmadigi veya belli bir doygunluga ulastigi durumda bosaltima geçmesi komutu için kablosuz bilgi transferi özelligi de vardir. Eger karin içi basincin artmasi devam ediyor ve bu limitler istenilen seviyeye ulasmadiysa bosaltma zamani gelse bile bu zamanin uzatilmasini saplayarak diyaliz isleminin daha verimli olmasini saglamasina yardimci olur. Sistemizi tek kullanimlik ve bu is için tasarlanmis konnektörü olan basinç sensörünün Modüle takilmasi sayesinde ilave kablo kullanimini ortadan kaldirir. Cihazimiz AA kalem pik boyunda oldugundan gerek bebekler gerek yetiskinler için Vücutta tasinmasini oldukça kolaylastirir. Mevcut bulus yukarida bahsedilen problemlerin üstesinden gelerek, hastanin kullanimi için daha güvenli, kullanimi kolay ve tibbi personelin takibine elverisli bir sürekli ayaktan periton diyalizi sistemi sunmaktadir. Bulusun Kisa Açiklamasi Mevcut bulus yukarida belirtilen mekanik manuel ölçüm zorluklari ve problemleri asmak üzere bir vücut içi basinç ölçümü ve ölçün sirasinda basinç verilerin toplanmasina ve islenmesine iliskin bir yöntem sunmaktadir. Bulus sürekli vücut içi basinç ölçümü için hat üzerinde basinç sensörü ( 5 ] modülü , modülden bilgiyi basinç sensörüne bagli dahili konnektörle alan modüle baglanan cihaz kismi (12] ni ihtiva Cihaz içinde kablosuz haberlesme modülü (3] , ayri veya modülün içinde bulunan mikroislemci kismi ( 3 ], düsük güç harcayan LCD grafik gösterge (8] , , Basincin istenilen seviyede olmadigi durumda sesli uyari için buzzer (2] , titresim m0dülü(4], batarya (7] ve muhtelif elektronik komponentlar ihtiva etmektedir. Sekillerin Kisa Açiklamasi Sekil 2/1 , Karin içinde bulunan ve vücut disinda kalan kismina ait sensör (5] ve bunu takilan cihaz (12] kisminin görünüsüdür. Burada vücut içi basincin aligilanmasini saglayan dahili konnektörlü sensör ( 5] ,ve cihazin iç yapisini gösteren ait temsili çizimidir. Sekil 2/2, mevcut bulusun bir yapilanmasina göre sunulan karin içi basinç ölçme kayit etme cihazinin (12] detay görüntüsünün gösteren temsili bir çizimidir. Sekil 2/2 , cihazin kapali görünüsü ( 12 ] Sekil 2/1 , içinde bulunan pil (7] , herhangi olumsuz bir durumda sesli uyari (2 ] buzzer ve titresimli uyari (4] elemani , düsük güç harcayan sivi kristal (LCD ] uyari ve bilgi ekrani (8] , kablosuz haberlesme saglayan haberlesme modülü (3] , mikrobilgisayar ve analog digital çeviricili ana islem birimi (3] , cihazin açik oldugunu gösteren LED ( 10 ] temsili çizimidir. Bulusun Ayrintili Açiklamasi Mevcut bulusa ait karin içi basiç ölçme kayit etme cihazinin (12] ayrintilari Sekil 2/1 de gösterilmistir. Bu cihaz (12] teknigin bilinen durumunda mevcut tertibatlarda bilindigi üzere basinç degerlerinin okundugu ve tek kullanimlik atilabilir (disposible) konnektörü üzerinde bir basinç sensörü bölümü ( 5] ve sensörün baglandigi kayit alma, log tutma , belirlenen basinç seviyelerinin asilmasi durumunda sesli, veya titresimli uyari veren ana cihaz (12] den olusur. Cihaz küçük bir kalem pil boyutunda oldukça hafif yüksek kapasite küçük boyutta pil (7] kullanan gerektiginde hastanin katater ve transfer set arasina baglanan basinç sensörünün üzerine takilarak olan kullanimi ve tasinmasi çok kolay bir sistemdir. Ayaktan periton diyalizi (Continuous Ambulatory Peritoneal Dialysis] sistemleri teknigin bilinen durumunda mevcuttur. Mevcut bulusun amaci, söz konusu Periton Diyaliz tedavisine yeni baslayan hastalarin karin içi basincini takip ederek periton zarinin geçirgenliginin tam olarak ögrenilmesini saglar. Özellikler prematüre, yenidogan ve çocuklarda bugüne yapilamayan karin içi basinç takibini mümkün kilar. Mevcut bulus böylece karin içi basincin kayidi sayesinde, güvenilir ve tibbi personelin kontrolüne imkan veren bir bilgi sunulmasidir. Kayit zamanlamasi ekrandan tuslarin yardimiyla 1 saniyeden 1 dakika araliginda bilgi kayit edilip depolanmasini saglar. Yani saatte 60 ile 3600 arasinda bilgi kaydi mümkündür. Bulusa ait karin içi basiç ölçme kayit etme cihazini (12), kayit ettigi bilgileri kablosuz haberlesme yöntemleriyle aktarir. Bu bilgiler cep telefonuna indirilen bir uygulama ile veya tablet veya bilgisayar gibi elektronik ortamlarda saglik personelinin bilgisine sunulur. Periton diyalizinde degisimlerin belli bir aralikta yapilmasi gerekir. Mevcut bulus karin içi basinç ölçme kayit etme cihazini karin içi basinç 'i sürekli takip ederek hastanin reçetesindeki zamana göre hastanin karnindaki Periton Diyalizi sivisin bekleme süresini arttirmasi veya bosaltima hemen baslanmasi konusunda bilgilendirme yapar. Bu bilgilendirme kablosuz haberlesme (3) ile oldugu gibi buzzer ( 2) veya titresimle ( 4) ile de olabilir. Mevcut bulus, daha özel bir yapilanmada, yogun bakimda tedavi gören yenidogan , prematüre ve çocuk periton diyalizi hastalarinin tedavi sirasinda olasi iç kanama riskini de saptayarak diyaliz solüsyonun erken bosaltilmasini ve kalp krizi yüksek tansiyon riskinin ortadan kaldirilmasina yardimci olur. TR TR DESCRIPTION MEASUREMENT, MONITORING AND RECORDING OF THE INTERNAL ABDOMINAL PRESSURE OF PERITHONEAL DIALISIS PATIENTS AND WARNING DEVICE IN CASE OF PRESSURE INCREASE. Technical Field to which the Invention Relates The present invention is based on the principle of continuous measurement of the intra-abdominal pressure of Peritoneal Dialysis patients. It is very important to use Peritoneal Dialysis patients in cases where constant monitoring of intra-abdominal pressure is required due to the Peritoneal Dialysis fluid they fill into their bodies. It is especially designed for use by newborn and young patients receiving peritoneal dialysis treatment. State of the Art Currently, intra-abdominal pressure or prostate pressure and bladder pressure are measured by filling the fluid produced to be used in the relevant area of the patient and measured as cm of water column with a ruler based on externally known mechanical observation. This is not a very laborious and continuous process. Peritoneal dialysis (PD) provides benefits by using a dialysis solution or dialysate filled into the patient's peritoneal cavity. The dialysate comes into contact with the peritoneal membrane of the peritoneal cavity. Diffusion and osmosis exchanges occur between solution and blood circulation across the peritoneal membrane. Accordingly, waste, toxins and excess water in the patient's bloodstream pass through the peritoneal membrane into the dialysate. The dialysate consumed in the peritoneal cavity is evacuated from the patient's abdominal cavity, removing excess waste, toxins and excess water from the blood. This cycle may be repeated throughout the night, in which case an automatic dialysis machine is used because the patient may fall asleep. This cycle can be repeated throughout the day and this system is called "continuous ambulatory peritoneal dialysis" (CAPD). The treatment performed at night is called APD Instrumented Peritoneal Dialysis. Continuous ambulatory peritoneal dialysis (CAPD) is a 24-hour dialysis system. Patients can walk, lie down or work during dialysis. In this system, approximately 2 liters of dialysis fluid in adults, 10 ml in newborns or premature babies, and 300-500 milliliters in children are infused into the peritoneum through a peritoneal dialysis catheter. Dialysis begins as soon as the dialysis fluid is drained into the peritoneum. The purification process takes place in this membrane inside the patients' abdomen, and unwanted substances are purified from the blood in this process. This process is called "waiting time". The dirty dialysate fluid is then evacuated from the abdomen and this evacuation period takes approximately 20-30 minutes. After this, the new sterile fluid is gravity loaded into the mixture, taking approximately 6-8 minutes, and this process begins again. These cycles continue all day as long as the doctor determines. Continuous ambulatory peritoneal dialysis is not as successful as healthy kidneys in fluid evacuation. Therefore, there is a "dry weight" that must be maintained during the process. At this weight, patients' blood pressure should be at normal levels and there should be neither overload nor underload. Fluid overload causes the heart to work harder than normal and causes high blood pressure. When high blood pressure becomes permanent, it can cause constant strain on the heart and increase the risk of heart attack. Therefore, in order to reduce the risk of undesirable heart diseases, it is very important to keep the amount of fluid the patient takes and gives under constant control. In order not to put too much strain on the heart, the intra-abdominal pressure should not exceed certain values (for example, 18 cm of water column). Even the gas in the patient's intestines increases intra-abdominal pressure, which carries the risk of dangerous consequences for the heart. It is very important to monitor this pressure in children, especially in premature and newborn babies. Our invention allows the intra-abdominal pressures of such problematic patients to be constantly monitored. APD (Instrumental Peritoneal Dialysis) patients connect themselves to the APD device when they come home in the evening and while they are sleeping. The APD device fills the patient within the pre-programmed time, waits and discharges and calculates the volumes. If the desired amount is discharged, it moves to the second filling phase. In our system, since the patient's intraperitoneal pressure is constantly monitored, the increased pressure in the abdomen due to dialysis is constantly monitored, and there is also a wireless information transfer feature for the command to evacuate in case the pressure does not increase or reaches a certain saturation. If the intra-abdominal pressure continues to increase and these limits have not reached the desired level, it helps the dialysis process to be more efficient by extending this time even if it is time to evacuate. Your system eliminates the use of additional cables by plugging the pressure sensor, which is disposable and has a connector designed for this purpose, into the Module. Since our device is AA pencil size, it makes it very easy to carry on the body for both babies and adults. The present invention overcomes the above-mentioned problems and offers a continuous ambulatory peritoneal dialysis system that is safer for the patient, easier to use and convenient for medical personnel to follow. Brief Description of the Invention The present invention provides an intrabody pressure measurement to overcome the difficulties and problems of mechanical manual measurement mentioned above and a method for collecting and processing pressure data during the measurement. The invention includes an in-line pressure sensor (5] module for continuous intrabody pressure measurement, a device part (12] connected to the module that receives information from the module via an internal connector connected to the pressure sensor, a wireless communication module (3] within the device, a microprocessor part (separate or inside the module) 3 ], low-power LCD graphic display (8], , Buzzer (2] for audible warning in case the pressure is not at the desired level, vibration module (4), battery (7] and various electronic components. Brief Description of the Figures Figure 2/ 1 is the view of the sensor (5] located in the abdomen and outside the body and the device (12] attached to it. Here is the sensor (5] with internal connector that allows the perception of intra-body pressure, and the representative drawing showing the internal structure of the device. Figure 2/ Figure 2 is a representative drawing showing the detail view of the intra-abdominal pressure measurement recording device (12), which is presented according to an embodiment of the present invention. Figure 2/2, the closed view of the device (12). audible warning (2] buzzer and vibrating warning (4] element, low-power liquid crystal (LCD) warning and information display (8), communication module providing wireless communication (3), microcomputer and main processing unit with analog to digital converter ( 3] is the representative drawing of the LED ( 10 ] showing that the device is on. Detailed Description of the Invention The details of the intra-abdominal pressure measurement recording device (12) of the present invention are shown in Figure 2/1. This device (12), as known in the existing devices in the state of the art, allows pressure values to be read and a pressure is recorded on its disposable connector. It consists of the sensor section (5] and the main device (12] to which the sensor is connected, which provides recording, logging, and gives an audible or vibrating warning in case the specified pressure levels are exceeded. The device is very lightweight, the size of a small pen battery, and uses a small size battery (7] with high capacity. It is a system that is very easy to use and carry, when necessary, by attaching it to the pressure sensor connected between the patient's catheter and the transfer set. Ambulatory peritoneal dialysis (Continuous Ambulatory Peritoneal Dialysis) systems are available in the state of the art. The aim of the present invention is to intra-abdominal patients who have just started Peritoneal Dialysis treatment. It allows the permeability of the peritoneal membrane to be learned exactly by monitoring the pressure. Features make it possible to monitor intra-abdominal pressure in premature babies, newborns and children, which has not been possible until now. The present invention thus provides information that is reliable and allows control by medical personnel, thanks to the recording of intra-abdominal pressure. Recording timing allows information to be recorded and stored between 1 second and 1 minute with the help of buttons on the screen. In other words, it is possible to record between 60 and 3600 data per hour. The intra-abdominal pressure measurement recording device (12) of the invention transfers the recorded information via wireless communication methods. This information is presented to healthcare personnel through an application downloaded to a mobile phone or in electronic media such as a tablet or computer. In peritoneal dialysis, changes must be made at a certain interval. The present invention uses the intra-abdominal pressure measuring and recording device to continuously monitor the intra-abdominal pressure and informs the patient to increase the waiting time for the Peritoneal Dialysis fluid in the patient's abdomen or to start evacuation immediately, according to the time prescribed by the patient. This notification can be provided by wireless communication (3), buzzer (2) or vibration (4). In a more specific embodiment, the present invention helps to eliminate the risk of early evacuation of dialysis solution and high blood pressure of heart attack by detecting the possible risk of internal bleeding during treatment of newborn, premature and child peritoneal dialysis patients treated in intensive care. TR TR

Claims

Pressure sensor (5), Analog/Digital converter (3), audible (buzzer) warning element (5), which is easily connected to the system as a clip with a specially designed connector, which is located on the set, which is connected to the patient's catheter and is generally called a transfer set.

2), vibration warning element (4), wireless data transmitter (3), LCD screen on which the information is read. A continuous intra-abdominal pressure measurement and monitoring device presented according to Claim 1, which controls the system and produces a control signal when it is greater than the specified value. It is suitable for wireless communication. system (

3) It contains. The continuous intra-abdominal pressure measurement and monitoring device presented according to claim 1 performs pressure measurements of the patient at certain intervals and contains a memory (1) to store over time. The continuous intra-abdominal pressure measurement and monitoring device presented according to claim 1 contains a buzzer that warns the patient with a sound (2) when it reaches the levels determined as an alarm. The continuous intra-abdominal pressure measurement and monitoring device, presented according to claim 1, vibrates to the patient when it reaches the levels determined as an alarm.

4) It contains a vibrating warning element that gives warning. The continuous intra-body (abdominal) pressure measurement and monitoring device presented according to claim 1 contains a module that sends alarm information (3) via wireless vibration to the patient's smart watch upon request when it reaches alarm levels. A continuous intra-body (abdominal) pressure measurement and monitoring device presented according to claim 1, comprising (12) an internet communication protocol for wireless communication (3). According to Claim 1, our device does not have a pressure sensor (5) on its connector and any cable that allows it to connect with the main unit (12), and it contains a system that provides comfort to the patient by keeping it inside the patient's clothing.

5) and the System (12) are connected to each other wirelessly with a connector, it contains a solution that eliminates the problems that may arise from the cable.