Abstract: Clinically, the catheter needs to be in contact with the body tissues for a long time or a short period of time. Each time the tissue is inserted or pulled out, the patient will have different degrees of burning pain, which may cause corresponding mucosal damage and even tissue inflammation. This is mainly caused by the large surface friction coefficient of the catheter and the body tissue. In this paper, the Labthink friction coefficient meter is used to detect the surface friction coefficient of the catheter, and the importance of the surface friction coefficient detection of the catheter and the surface lubrication treatment method are further described.
Key words: catheter, medical catheter, friction coefficient, smoothness
Author: Labthink Technology Co., Ltd.
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The medical catheter is a general term for connecting the internal and external luminal products of the human body, and is widely used in clinical fields such as administration, perfusion, and drainage through intravenous catheters, cannulas, and catheters. Among them, the catheter is an indispensable medical device in clinical application, and its emergence has made some dangerous and complicated traditional treatment methods find an ideal alternative method, thereby improving the medical level and the patient's physique and Rehabilitation of physiological functions. The catheter is made of natural rubber, silicone rubber or polyvinyl chloride ( PVC ). It can be inserted into the bladder through the urethra to drain the urine. After the catheter is inserted into the bladder, there is an airbag near the head of the catheter. The fixed catheter remains in the bladder and is not easily prolapsed, and the drainage tube is connected to the urine bag to collect urine.
Clinically, the catheter needs to be in contact with the body tissues for a long time or a short period of time. Each time the tissue is inserted or pulled out, the patient will have different degrees of burning pain, which may cause corresponding mucosal damage and even tissue inflammation. This is mainly due to the large coefficient of friction of the catheter. The coefficient of friction is mainly to guide the coefficient of friction generated between the surface material of the urethra and the patient's matrix tissue. There is currently no clear standard in the industry to determine how to detect its indicators. With many years of testing experience and strong technical strength, Labthink Labs can professionally perform the surface friction coefficient test of medical catheters by special modification of its own product MXD-02 friction coefficient meter. The test method will be described in detail below.
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(A) catheter surface friction coefficient test
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Test location: Languang Packaging Safety Testing Center
Test instrument: MXD-02 friction coefficient meter
Test preparation:
Take 36 latex catheters , PVC and PUR . Latex catheter, for example, divided into three groups each of a set of 12 * test group was the control group, the second group PVP lubricated, the third group coated with paraffin oil, the water soaked into groups of 6 30s, The other 6 were soaked in water for 24 hours . PVC and PUR urinary catheters were prepared in the same manner.
Test Methods:
Test control group taken into water soaked sample 2 30s by clamping means fixed to the sample ①② V-shaped groove plate, poured into water until the sample is completely immersed ③ wherein the storage tank. 200g of the standard slider ④ ⑤ above the light into the sample, the sensor connected by a lever drag the slider ⑥ shown by the arrow direction at a speed moving 100mm / min, the coefficient of dynamic friction can be measured, taking a final ZUI 6 The average coefficient of friction of the sample. The same method was used to test the friction coefficient of the other two materials in different soaking times.
Equipment introduction:
The MXD-02 friction coefficient meter is a professional-grade intelligent friction coefficient meter independently developed by Labthink . The equipment meets various standards of GB , ASTM and ISO , and can be professionally applied to measure the static friction coefficient of plastic film and sheet, rubber, paper, cardboard, woven bag, fabric style, conveyor belt, wood, coating, brake pad and other materials. And dynamic friction coefficient. The MXD-02's integrated PVC operator panel , micro-printer and LCD screen for test data, results and curves allow users to perform computer-free tests. The professional test software has an intuitive operation interface, real-time data display and composition function, supports the test results EXCEL format export, can carry out scientific statistical analysis processing of single or group test results, historical data comparison and group test curve superposition analysis. The powerful data analysis function can also help users to perform quantitative and discrete analysis of test results and judge the slip-stick state by preset oscillating coefficients.
Test Results:
(two) catheter lubrication surface treatment method
In clinical treatment, the catheter needs to be in contact with the body tissues for a long time or a short period of time. Each time the tissue is inserted or pulled out, the patient may have different degrees of burning pain, which may cause corresponding mucosal damage and even tissue inflammation. This is mainly due to the large friction coefficient between the surface material of the catheter and the body tissue. Therefore, researchers and medical personnel have used various means to lubricate the surface of the catheter to alleviate the iatrogenic pain of the patient.
1. Paraffin oil or complex iodine coating
Paraffin oil is a kind of mineral oil. It is applied to the surface of the catheter with a cotton ball to make it have a good lubricating effect. However, in clinical application, there are several risks in this method: 1. Cotton ball smearing increases the chance of bacterial infection; 2. Paraffin oil is not absorbed by the mucous membrane. If the operation is accidentally entered into the trachea or infiltrated into the tissue, it may cause other diseases. . Therefore, this lubrication method is gradually being eliminated by the industry. Complex iodine smearing is a new attempt and new research in recent years. Complex iodine is iodophor, which is a complex of non-toxic and odorless traditional fungicides. At the same time, it is a water-soluble reagent. The strong mucosal permeability makes it a bactericidal effect when used as a catheter lubricant. It prevents bacteria from being carried into the bladder through the catheter and reduces the chance of urinary tract infection. This method of overcoating is simple and easy, and the cost is low, but there are two common drawbacks: 1. It is impossible to fully lubricate every part of the catheter; 2. During the intubation process, the lubricant and the urethra are constantly rubbed. Continuous wear and tear, increased friction damage between the catheter and the urethra.
Second, silicone coating
The silicone-coated catheter is mainly adhered to the surface of the catheter by dipping, spraying or brushing with a curable silicone elastomer to form a silicone elastomer lubricating film. Through practice, the effect of repeated impregnation is good, and the total thickness of the coating and the uniformity of each part can be effectively controlled. After the coating reaches the specified thickness, the catheter is cured at room temperature 25 ° C , 10-50% RH for 16 hours, and the lubricating film achieves the desired characteristics within seven days. This silicone-coated catheter reduces friction and damage to the body tissue during insertion and reduces the risk of infection.
Third, water-soluble lubricating coating
This method firstly coats the stable polymer solution on the surface layer of the catheter, and after drying, the hydrophilic polymer which is not chemically reacted is bonded as a surface layer on the stable polymer coating layer, and dried again. It can be a solid water-soluble lubricating coating. The polymer solution should be selected from cellulose esters with strong adhesion as a substrate to increase the firmness of the coating and the surface layer of the catheter. The choice of hydrophilic polymer is related to the lubricating effect of the coating. Polyvinylpyrrolidone ( PVP ) as a water-soluble polymer compound has been proven to have good physiological compatibility and solubility for many years. As a lubricating layer for the catheter. In the dry state, the catheter with water-soluble lubricating coating is no different from the common catheter. When the coating is in contact with the aqueous liquid, the PVP molecules quickly absorb water to form a hydrophilic gel layer and will not fall off. The tube is fully lubricated. It has been proved by experiments that with the increase of PVP coating content, the friction coefficient of the surface of the catheter gradually decreases. This is because the PVP content increases, and the more PVP molecules entangled with the surface of the catheter , the hydrogel layer formed after water absorption. The thicker, the condensation of water molecules reduces the friction area of ​​the catheter substrate and the external tissue, and the friction coefficient is correspondingly reduced. In this way, in addition to reducing the friction of the catheter to the urethra to a large extent, reducing the risk of pain and infection, the safety is also greatly improved.
During the PVP coating process, the water content of PVP will have an effect on the lubrication effect. Due to its own characteristics and moisture absorption, the water content of PVP raw materials is 3%~5% . According to industry experts, when the water content exceeds 1% , the coating tends to be uneven, resulting in unsatisfactory lubricity. Therefore, it is recommended to dry the PVP raw material before coating to control the water content within a reasonable range.
The Languang Packaging Safety Testing Center also tested the friction coefficient of the three types of urinary catheters that were lubricated. The test results show that: whether it is lubrication effect or stable and durable, the effect of lubricating the surface of the catheter with PVP is better than that of paraffin oil. The catheter made by this method can be immersed in sterile water and rapidly formed. The hydrophilic gel layer is abnormally lubricated, which greatly reduces the friction coefficient between the catheter and the body tissue and the patient's intubation pain, and has no adverse reactions. Therefore, the method can be regarded as the surface lubrication treatment of the catheter. The ideal method.
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