TR201909044A2 - A system for measuring blood glucose in newborns. - Google Patents
A system for measuring blood glucose in newborns. Download PDFInfo
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- TR201909044A2 TR201909044A2 TR2019/09044A TR201909044A TR201909044A2 TR 201909044 A2 TR201909044 A2 TR 201909044A2 TR 2019/09044 A TR2019/09044 A TR 2019/09044A TR 201909044 A TR201909044 A TR 201909044A TR 201909044 A2 TR201909044 A2 TR 201909044A2
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- 210000004369 blood Anatomy 0.000 title claims abstract description 55
- 239000008280 blood Substances 0.000 title claims abstract description 55
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 title claims abstract description 38
- 239000008103 glucose Substances 0.000 title claims abstract description 38
- 238000005259 measurement Methods 0.000 claims abstract description 30
- 235000019420 glucose oxidase Nutrition 0.000 claims description 7
- 238000000034 method Methods 0.000 claims description 7
- 239000012528 membrane Substances 0.000 claims description 6
- 150000002978 peroxides Chemical class 0.000 claims description 6
- 108010015776 Glucose oxidase Proteins 0.000 claims description 4
- 239000004366 Glucose oxidase Substances 0.000 claims description 4
- 229940116332 glucose oxidase Drugs 0.000 claims description 4
- 239000000126 substance Substances 0.000 claims description 4
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 claims description 3
- 229910052739 hydrogen Inorganic materials 0.000 claims description 3
- 239000001257 hydrogen Substances 0.000 claims description 3
- 239000007788 liquid Substances 0.000 claims description 3
- 208000024248 Vascular System injury Diseases 0.000 claims description 2
- 208000012339 Vascular injury Diseases 0.000 claims description 2
- 239000003146 anticoagulant agent Substances 0.000 claims description 2
- 229940127219 anticoagulant drug Drugs 0.000 claims description 2
- 238000001514 detection method Methods 0.000 claims description 2
- 238000006395 oxidase reaction Methods 0.000 claims description 2
- 210000002381 plasma Anatomy 0.000 claims description 2
- 230000015556 catabolic process Effects 0.000 claims 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 24
- 210000001644 umbilical artery Anatomy 0.000 description 3
- 210000003606 umbilical vein Anatomy 0.000 description 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 208000035475 disorder Diseases 0.000 description 2
- 210000003722 extracellular fluid Anatomy 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 210000003462 vein Anatomy 0.000 description 2
- 206010008111 Cerebral haemorrhage Diseases 0.000 description 1
- 206010010904 Convulsion Diseases 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 206010018852 Haematoma Diseases 0.000 description 1
- 208000032843 Hemorrhage Diseases 0.000 description 1
- 208000013016 Hypoglycemia Diseases 0.000 description 1
- 206010031252 Osteomyelitis Diseases 0.000 description 1
- 206010033425 Pain in extremity Diseases 0.000 description 1
- 206010062255 Soft tissue infection Diseases 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 208000007502 anemia Diseases 0.000 description 1
- 230000002429 anti-coagulating effect Effects 0.000 description 1
- 208000034158 bleeding Diseases 0.000 description 1
- 230000000740 bleeding effect Effects 0.000 description 1
- 230000036765 blood level Effects 0.000 description 1
- 238000010241 blood sampling Methods 0.000 description 1
- 210000004556 brain Anatomy 0.000 description 1
- 230000036461 convulsion Effects 0.000 description 1
- 238000000354 decomposition reaction Methods 0.000 description 1
- 238000006073 displacement reaction Methods 0.000 description 1
- 229940088598 enzyme Drugs 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
- 239000010931 gold Substances 0.000 description 1
- 229910052737 gold Inorganic materials 0.000 description 1
- 201000001421 hyperglycemia Diseases 0.000 description 1
- 230000002218 hypoglycaemic effect Effects 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000000691 measurement method Methods 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 230000001123 neurodevelopmental effect Effects 0.000 description 1
- 230000002028 premature Effects 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 210000004872 soft tissue Anatomy 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 230000000472 traumatic effect Effects 0.000 description 1
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- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
Abstract
Buluş, yenidoğan bebeklerde sürekli kan şekeri ölçümü yapılması için bir sistem ile ilgilidir. Buluş konusu sistemde; sürekli glukoz (kan şekeri) ölçüm (CGM) cihazları bebeklere uygulanan kataterlere entegre edilerek gerçek zamanlı ve sürekli kan şekeri ölçümü alınması sağlanmaktadır. Buluş ile yenidoğanlarda ağrılı ve çok sayıda girişim yapmaksızın, sürekli kan şekeri ölçümünThe invention relates to a system for continuous blood glucose measurement in newborn babies. In the system of the invention; Continuous glucose (blood glucose) measurement (CGM) devices are integrated with catheters applied to babies, enabling real-time and continuous blood glucose measurement. With the invention, it is possible to measure blood glucose continuously in newborns without painful and multiple interventions.
Description
TARIFNAME YENIDOGANLARDA KAN SEKERI öLçÜMÜ IÇIN BIR SISTEM Bulusun Ilgili Oldugu Teknik Alan Bulus; yenidogan bebeklerde sürekli kan sekeri ölçümü yapilmasini saglayan bir sistem ile ilgilidir. Bulus konusu sistemde; sürekli glukoz (kan sekeri) ölçüm (CGM) cihazlari bebeklere uygulanan kataterlere entegre edilerek gerçek zamanli ve sürekli kan sekeri ölçümü alinmasi saglanmaktadir. DESCRIPTION A SYSTEM FOR MEASURING BLOOD SUGAR IN NEWDOGANS Technical Field of the Invention Meet; A system that enables continuous blood sugar measurement in newborn babies. It is related to. In the system that is the subject of the invention; continuous glucose (blood sugar) measurement (CGM) devices real-time and continuous blood sugar by integrating into catheters applied to babies measurement is provided.
Bulusla Ilgili Teknigin Bilinen Durumu (Önceki Teknik) Yenidoganlar, özellikle düsük ve asiri dogum agirlikli ve ileri derece prematüre olan yenidoganlar, hayatin ilk saatlerinden itibaren birkaç haftaya kadar uzayan periyotlarda kan sekeri regülasyon bozuklugu yasamaktadir. Hiperglisemi (yüksek kan sekeri) ve hipoglisemi (düsük kan sekeri), bebeklerde özellikle beyin ile ilgili kisa ve uzun dönemde görülen ciddi sorunlara (konvülziyon, beyin kanamasi ve nörogelisimsel sorunlar) neden olmaktadir. Bu nedenle, bebeklerde kan sekerinin normal düzeylerde devam ettirilmesi gerekir. Bu da, kan sekeri düzeylerinin yakin takibi ile mümkün olmaktadir. Yenidogan bebeklerde dogumdan sonra siklikla karsilasilan bu kan sekeri regülasyonundaki bozukluklar nedeniyle belli araliklarla kan sekeri ölçümü gereklidir. State of the Art of the Invention (Prior Art) Newborns, especially those with low and excessive birth weight and extremely premature newborns, from the first hours of life up to several weeks He has a blood sugar regulation disorder. Hyperglycemia (high blood sugar) and hypoglycemia (low blood sugar), in infants, especially in the short and long term related to the brain cause serious problems (convulsions, cerebral hemorrhage and neurodevelopmental problems) is happening. Therefore, it is necessary to maintain normal blood sugar levels in infants. must. This is made possible by close monitoring of blood sugar levels. Newborn This blood sugar regulation, which is frequently encountered in infants after birth, Due to disorders, blood sugar measurement is required at certain intervals.
Günümüzde yenidoganlarda kan ölçümleri, genelde bebeklerin topuk kani (kapiller) ya da venöz (toplar damar) kan örnekleri alinarak yapilmaktadir. Bu yöntemlerde, özellikle kan sekeri düzeyleri anormal seyreden bebeklerde saatlik olarak kan alinmasini gerektirmektedir. Kan sekeri düsük/yüksek bebeklerde takip ve tedavinin yönlendirilmesi yapilmasi gerekmektedir. Kapiller ve venöz kan sekeri örneklemesi, invazif ölçüm oldugu için agrili olmakta ve özellikle venöz kan sekeri ölçümünde asiri kan alinmasina neden olmaktadir. Topuktan alinan örneklemlerde agriya ek olarak, zaten çok küçük olan bebeklerin topuk bölgesinde kanama, hematom, cilt/yumusak doku/kemik enfeksiyonlari, doku kaybi, vb. sorunlara neden olabilmektedir. Bazi hasta yenidoganlarda bir haftayi geçebilmekte daha da uzun sürebilmektedir. Sik yapilan kan örneklemeleri, kan sekeri regülasyonunun uzun dönemde saglanabildigi vakalarda oldukça travmatik ve agrili bir hal almakta ve asiri kan alimina bagli anemi gelisebilmektedir. Today, blood measurements in newborns are usually the heel blood (capillary) or It is done by taking venous (vein) blood samples. In these methods, especially blood hourly blood sampling in infants with abnormal sugar levels requires. Follow-up and guidance of treatment in infants with low/high blood sugar needs to be done. Capillary and venous blood glucose sampling, as invasive measurement It is painful for the patient and causes excess blood to be taken, especially in the measurement of venous blood sugar. is happening. In addition to pain in heel samples, already very small bleeding, hematoma, skin/soft tissue/bone infections in the heel area of babies, tissue loss, etc. can cause problems. In some sick newborns, a week may take even longer. Frequent blood samples, blood sugar In cases where its regulation can be achieved in the long term, it is a very traumatic and painful and anemia may develop due to excessive blood intake.
Teknigin bilinen durumunda var olan yenidoganlarda kan sekeri ölçüm yöntemlerinde; venöz kan örneklerinden biyokimya laboratuvarinda otoanalizörler ile ölçümü yapilmakta veya kapiller kan örneklerinden glukostick ile hasta basi ölçümü yapilmaktadir. Bunlara ek olarak; mevcut teknikte sürekli glukoz ölçümü yapan sistemler (CGM) var olup, sensör igneleri deri altina yerlestirilerek hücreler arasi sivinin seker seviyesini ölçülmektedir. In the current state of the art, blood glucose measurement methods in newborns; Venous blood samples are measured with autoanalyzers in the biochemistry laboratory. Head-to-head measurement is made with glucostick from capillary or capillary blood samples. To these In addition; In the current art, there are systems (CGM) that measure glucose continuously. The sugar level of the intercellular fluid is measured by placing the needles under the skin.
Günümüzde kullanilmakta olan sürekli kan sekeri ölçümü cihazlarinda sensörlerin ucu cilt altina yerlestirilmekte, cildin üstte kalan kismi bir transmittere baglanmaktadir. Bu transmitter de kablosuz baglanti ile CGM cihazina ileti göndererek kan sekeri düzeyinin CGM cihazi ekranindan okunmasini saglamaktadir. Ancak CGM sistemlerinde de; cihazin uygulama zorlugu, agriya sebep olmasi, sensör ignesinin yer degistirmesi, interstitiel sivida glukoz degisikliklerinin yavas olmasi nedeniyle dinamik kan sekeri ölçümünde yetersiz olmasi gibi dezavantajlar bulunmaktadir. In the continuous blood glucose measurement devices used today, the end of the sensors are on the skin. It is placed under the skin, and the upper part of the skin is connected to a transmitter. This The transmitter sends a message to the CGM device with a wireless connection, and the blood sugar level is determined. It allows reading from the CGM device screen. However, in CGM systems; your device difficulty in application, causing pain, displacement of the sensor needle, interstitial in dynamic blood glucose measurement due to slow fluid glucose changes. There are disadvantages, such as inadequacy.
Söz konusu bulus; yenidoganlarda sürekli kan sekeri ölçümü yapilmasi için teknigin bilinen durumunda var olan dezavantajlarin giderildigi bir cihaz ile ilgilidir. The invention in question; technique for continuous blood glucose measurement in newborns. It relates to a device in which the disadvantages existing in the known state are eliminated.
Bulusun Kisa Açiklamasi ve Amaçlari Mevcut bulusta, sürekli glukoz ölçüm (CGM) cihazinin umblikal arter/ven kataterine entegre edildigi, yenidoganlar için sürekli kan sekeri ölçümü yapilmasini saglayan bir sistem açiklanmaktadir. Brief Description and Objectives of the Invention In the present invention, the continuous glucose measurement (CGM) device is connected to the umbilical artery/vein catheter. It is an integrated system that provides continuous blood glucose measurement for newborns. system is explained.
Bulusun bir amaci; yenidoganlarin kisa araliklarda (örnegin saatlik) yapilan kan sekeri düzeyi takipleri için sürekli lanset/igne ile kan alinmasinin engellenmesidir. Bu sekilde, hem olusacak agri hem de fazla kan kaybi engellenmektedir. An aim of the invention is; short-term (for example, hourly) blood sugar of newborns It is the prevention of blood collection with a continuous lancet/needle for blood level follow-ups. In this way, pain and excessive blood loss are prevented.
Söz konusu bulus; hastalara agrisiz bir sekilde takilabilen umblikal arter/ven kataterine entegre bir cihaz oldugundan hastanin kan sekeri ölçümü konforlu bir sekilde yapilabilmekte ve sürekli damara girip çikilmasindan ya da Ianset batirilmasindan kaynaklanan rahatsizliklar elimine edilmektedir. The invention in question; umbilical artery/vein catheter that can be inserted painlessly to patients Since it is an integrated device, the patient's blood sugar measurement can be carried out comfortably. It can be done and it can be done and it can be done and it can be done without getting in and out of the vein or Ianset. inconveniences are eliminated.
Bulus sayesinde; gerçek zamanli ölçümler yapilarak, gerekli müdahaleler zamaninda yapilabilecektir. Thanks to the invention; By making real-time measurements, necessary interventions are made in a timely manner. can be done.
Bulusu Açiklayan Sekillerin Tanimlari Sekil 1: Bulus konusu kan sekeri ölçüm sistemi Bulusu Olusturan UnsurlarinlKisimIarin/Parçalarin Tanimlari Bu bulus ile gelistirilen kan sekeri ölçüm sisteminin daha iyi açiklanabilmesi için sekillerde yer alan parça ve kisimlar numaralandirilmis olup, her bir numaranin karsiligi asagida verilmektedir: CGM cihazi-sensör baglantisi Sensör Modifiye CGM cihazi Bulusun Ayrintili Açiklamasi Mevcut bulus; bir umblikal venöz veya arter kateteri (1), kateter (1) üzerine/içine entegre edilmis CGM cihazi-sensör baglantisi olan iletken tel (2) ve sensör (3) ile modifiye sürekli glukoz ölçüm (CGM) cihazi (4) içeren yenidoganlarda kan sekeri ölçülmesi için bir sistem ile ilgilidir. Description of Figures Explaining the Invention Figure 1: Blood glucose measurement system of the invention Definitions of Invention Elements,Parts/Parts In order to better explain the blood glucose measurement system developed with this invention, the figures are given. The parts and parts in this part are numbered and the corresponding number of each number is given below. are given: CGM device-sensor connection You ask Modified CGM device Detailed Description of the Invention The present invention; an umbilical venous or arterial catheter (1) integrated on/in the catheter (1) Modified continuous wire (2) and sensor (3) with a modified CGM device-sensor connection A system for measuring blood glucose in newborns incorporating a glucose meter (CGM) device (4) It is related to.
Bulusa konu sistemde, CGM cihazi sensör baglantisi olan iletken tel (2) olup umbilikal arter/venöz kateteri (1) üzerinde/içinde yerlesik bulunmakta olup, sterildir ve üzeri katater materyeli ile kaplidir. Sensör (3), hastanin kani ile temas etmesi için kateterin (1) disinda konumlandirilmaktadir. Sensörün (3) kanla temas eden kisimlari antikoagülan özelliktedir. In the system that is the subject of the invention, the CGM device is the conductive wire (2) with the sensor connection and the umbilical arterial/venous catheter (1) has a built-in, sterile and overlying catheter covered with material. The sensor (3) is outside of the catheter (1) to come into contact with the patient's blood. is positioned. The parts of the sensor (3) that come into contact with blood have anticoagulant properties.
Glukoz oksidaz-peroksit yöntemi ile ölçüm yapan sensör (3), kan plazmasindaki sekere geçirgen, diger maddelere geçirgen olmayan yari-geçirgen membran ile kaplidir ve membranin altinda glukoz oksidaz enzim tabakasi bulunmaktadir. Glukoz oksidaz, glukoz (seker) ile karsilastiginda glukozu hidrojen ve peroksite parçalamaktadir. Kan sekeri ile orantili olarak olusan peroksitler sensörün (3) iç kismindaki elektorota çarptiginda olusan elektriksel potansiyel algilanmakta ve kan sekeri ölçümü saglanmaktadir. Elektrot tercihen altin kaplamadir. Sistemin çalismasi için gerekli elektrik enerjisi CGM cihazi içerisindeki pil ya da sistemin modüler olarak baglandigi hasta monitöründen alinmaktadir. The sensor (3), which measures with the glucose oxidase-peroxide method, measures the sugar in the blood plasma. covered by a semi-permeable membrane that is permeable, impermeable to other substances, and Under the membrane is the glucose oxidase enzyme layer. glucose oxidase, glucose (sugar) breaks down glucose into hydrogen and peroxide. with blood sugar produced when the proportionally formed peroxides hit the electrode inside the sensor (3). electrical potential is detected and blood sugar measurement is provided. electrode preferably is gold plated. The electrical energy required for the operation of the system is contained in the CGM device. battery or from the patient monitor to which the system is connected modularly.
Bulusa konu yenidoganlarda kan sekeri ölçüm sisteminin çalisma yöntemi; i. Sensörün (3) kapli oldugu yari-geçirgen membran altinda bulunan glukoz oksidaz enzim tabakasinin, glukoz (seker) ile karsilasmasiyla glukozun hidrojen ve peroksite parçalanmasi, ii. Glukoz oksidaz reaksiyonu sonucu açiga çikan peroksitin glukoz ile orantili olarak elektriksel bir deger olusturmasi, iii. Elektrot tarafindan bu degerin tespit edilmesi, iv. Glukoz degerinin sürekli glukoz ölçüm (CGM) cihazindan (4) okunmasi, Bulusta kullanilan CGM cihazi hücreler arasi sivi yerine, kandan ölçüm yapmaya uygun bir sekilde kalibre edilmektedir. Bulusta CGM cihazi-sensör baglantisi olan iletken tel (2), kateter (1) duvarina, kateterin (1) içerisinden ya da disarisindan yaslanacak sekilde uzatilmakta ve sensör (3) ölçüm yapabilmesi ve kan ile dogrudan temas etmesi için kateterin (1) disina yerlestirilmektedir. Working method of blood glucose measurement system in newborns, which is the subject of the invention; I. Glucose oxidase located under the semi-permeable membrane that the sensor (3) is covered with When the enzyme layer meets with glucose (sugar), glucose is converted to hydrogen and peroxide decomposition, ii. The peroxide released as a result of the glucose oxidase reaction is proportional to the glucose. creating an electrical value, iii. Detection of this value by the electrode, iv. Reading the glucose value from the continuous glucose measurement (CGM) device (4), The CGM device used in the invention is suitable for measuring blood instead of intercellular fluid. is calibrated in one way or another. Conductive wire (2) with CGM device-sensor connection in the invention, so that the catheter (1) rests against the wall, inside or outside the catheter (1) is extended and the sensor (3) is required to measure and come into direct contact with blood. It is placed outside the catheter (1).
Bulusta kullanilan sensör (3) kanla temas eden kisimlar antikoagülan madde ile kaplidir ve sterildir. The parts of the sensor (3) used in the invention that come into contact with blood are covered with an anticoagulant substance. and sterile.
Bulus konusu cihazdaki sensörün (3) uç kismi, umbilikal arter/ven kateterinden verilen sivilardan kaynaklanacak ölçüm hatalarini (kanin dilüe olmasi nedeniyle, oldugundan daha düsük ya da glukoz içerikli sivilarin verilmesi nedeniyle, oldugundan daha yüksek ölçme gibi) en aza indirmek için kateterin ucundan daha geri bir noktaya yerlestirilmektedir. Ayrica sensörün (3) damara temas etmesi nedeniyle olusabilecek damar yaralanmalarinin önlenmesi için sensörün (3) ucu yuvarlatilmis formdadir. The tip of the sensor (3) in the inventive device is the part of the umbilical artery/vein catheter. measurement errors caused by liquids (due to the blood being diluted, higher than usual due to the delivery of liquids with lower or glucose content. (such as measuring) to a point further back from the tip of the catheter to minimize is placed. In addition, due to the sensor (3) contacting the vessel, The tip of the sensor (3) is rounded in order to prevent vascular injuries.
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TR2019/09044A TR201909044A2 (en) | 2019-06-18 | 2019-06-18 | A system for measuring blood glucose in newborns. |
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