Release date: 2014-03-31 Diabetes is the third biggest threat to human health. The prevalence of diabetes in community surveys in major cities such as Shanghai and Beijing is over 10%. It is usually divided into type I (insulin dependent) and type II (insulin deficiency or lack of action). Both types of diabetics need insulin supplementation to maintain normal levels of blood glucose and low levels of glycated hemoglobin. Medicine is the current best treatment. Fractional injections have long been the only form of insulin delivery and are still dominant. However, the method of splitting long-acting insulin in different ways is different from the continuous secretion of short-acting insulin in normal human body. The main disadvantages are as follows: 1. The absorption mutation rate of long-acting insulin is up to 52%, which leads to extremely unstable blood sugar control. Bring pain and danger to the patient; 2, the operation is cumbersome, the patient has to receive an average of 1,643 injections per year, the treatment process is tense and painful. To this end, it is of great practical significance to study a scientific method of insulin administration, to alleviate the suffering of patients and accurately control the blood glucose level in patients. Invasive insulin pump is currently the best research program, but there are still two major defects in this method: 1. The blood glucose concentration cannot be obtained online, and the open-loop control mode cannot achieve accurate blood glucose concentration control; 2. The insulin filling mode The choice has limitations, and it is difficult for patients to determine the appropriate mode of administration; therefore, a new type of closed-loop artificial insulin pump is being developed, which can obtain the patient's blood glucose concentration online and control the administration of the human pancreatic secretion characteristics obtained experimentally. the amount. It can alleviate the suffering of patients and achieve scientific treatment. In recent years, research on insulin delivery devices has been widely carried out at home and abroad to precisely control blood glucose levels in patients while reducing patient suffering. At present, domestic and foreign research programs include: invasive insulin pump, no (micro) wound insulin pump, intelligent sensory polymer delivery carrier, insulin pen, etc. Throughout these several ways: insulin pen is essentially a grade Syringe, this method usually uses long-acting insulin, can not reduce the number of injections, can only help patients to achieve precise control of the amount of injection; intelligent polymer delivery system due to insulin biological activity and stability, carrier biodegradability and biological phase The constraints of factors such as capacitance, insulin loading efficiency, and intelligent release of insulin are still in the primary research stage; no (micro) wound insulin pump uses MEMS technology to make microneedle arrays that can penetrate into the stratum corneum of human skin to achieve painless blood sugar. Concentration collection and administration, the method is novel but the data fluctuation is particularly large, which makes the human test difficult to pass; the invasive insulin pump started in 1982, mainly composed of the power part, the drug container, the catheter, the injection needle, the power supply, etc.; The subcutaneous needle achieves continuous infusion of insulin throughout the day, eliminating the pain of multiple subcutaneous injections a day. It can be seen that the invasive insulin pump is currently the best research program. Many domestic and foreign companies have introduced BP-sized insulin pump products, but there are still two major defects in the insulin pump: the blood glucose concentration cannot be obtained online, and only the patient's blood sugar can be achieved. The concentration of the open loop control, so can not simulate the insulin secretion characteristics of the human pancreas to achieve the optimal level of blood sugar control. The choice of insulin filling mode has limitations. It is difficult for patients to determine the appropriate mode of administration. In order to improve the above defects, it is necessary to study the online acquisition of blood glucose concentration and the secretion characteristics of human pancreas. The current blood glucose concentration acquisition method is mainly for invasive collection. Blood, this way because of the pain caused by collecting up to several times a day, can not mark the impact of daily life events on blood sugar. Therefore, three research protocols are proposed at home and abroad: minimally invasive, non-invasive, and invasive implants; among them, minimally invasive use of reverse iontophoresis to obtain subcutaneous interstitial sugar molecules, and subcutaneous testing by electrochemical biosensors Exuded glucose, but the accuracy and repeatability of this method are far from the practical distance; non-invasive methods usually measure the blood glucose concentration in patients based on optical information, including near-infrared spectroscopy, far-infrared spectroscopy, Raman spectroscopy, acoustic spectroscopy, light scattering spectroscopy and Analysis of light polarization spectrum, etc., this method relies on special large-scale instruments and equipment to extract weak information, so the accuracy is not enough, and it does not meet the conditions of household use; the most advanced edge of invasive implants can meet the detection requirements of 7 days, but the detection Reagent supplementation is difficult and the cost of use is extremely high. Therefore, the use of the insulin pump injection needle wound blood glucose concentration online detection function, without the need for new patient trauma and pain, to achieve closed-loop control of blood glucose concentration, based on this theory to develop an integrated insulin pump, systematic clinical experiments, with important research Significance and market prospects. Source: Medical Device Innovation Network
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