The Development And Elemental Clinical Application Of Intrauterine Device Placer

Objective:This research belongs to the field of birth control, with the objective of improvement on the tube-type intrauterine device placer which is widely used. While a new type of intrauterine device placer is developed, which is adaptive with the hyster vertomet, without sharp front-end, cooperates with the use drug in hyster and can be degradated. This new intrauterine device placer cancel the defect and deficiency of the traditional ones, with great safety and convenience in the placing process, and the side effects and syndromes caused by intrauterine device placer will be reduced. The introducing manner is also established in this paper.Method:The research plan is passed by the ethics committee.1. Study in laboratory and feasibility study:The development of dedicated capsules based on the traditional manufacturing process of capsules. The simulation model and data acquisition system are established through the mechanics study on the dedicated capsules in the laboratory. The mechanics analysis during the resting period in vitro is done. The disintegration time limited of the dedicated capsules with different type of intrauterine devices is observed at the constant temperature in simulated uterine cavity liquid.There is a experimentation of a few volunteers on the disintegration of the capsules.2. Clinical compared study:according to the cases screening criteria strictly, 83 cases (including 33 cases of volunteers) were screened from the healthy married women of childbearing age who were at our hospital by the voluntary requirements of informed choice IUD placed during August 2008 to March 2009.They were grouped for being placed opened IUD or closed IUD, the same IUD placed in different apparatus (capsule-type placer and tube-type intrauterine placement device), A clinical comparative observation was did through establishing testing group and comparison group,including the subjective evaluation of the women, subjective evaluation of the operator, the success rate of one-time placement, the infection rate after the placement , the method of comparative observation in the study of the intrauterine hemorrhage after the placement (in 48 hours)was used to compare the endometrial damage. And there is a short-term follow-up visit about the clinical effect of the capsule-type placer and the occurrence of subsidiary reaction after the placement.Result:1.Study in laboratory: The simulation model of hyster and data acquisition system of mechanics parameter are established. The comparison is made between the mechanics parameter that create when the three different types of intrauterine device placers are placing in the simulation model of hyster, including tube-type intrauterine devices, the intrauterine device placer with tube-cap which is transition type and capsule-type placer. It is shown that mechanics adjustment of capsule-type intrauterine device placer is better. The disintegration limited time of capsule-type intrauterine device placer contained opened IUD in the uterine liquid is 8 minutes on average, the disintegration limited time of capsule-type intrauterine device placer contained closed IUD in the uterine liquid is 14 minutes on average.The capsules is able to be disintegrated in the uterine cavity.2. The clinical comparison and study: General character of things The comparison of age, number of pregnancy, parity, the depth of uterine cavity between the testing group and the comparison group during two placement teams makes non sense in the statistics(P>0.05). The states of placing process The mission success rate of placing the capsule-type intrauterine device placer is higher than the comparison group, The difference makes sense in the statistics(P<0.05). The women and the operators are more satisfied with the capsule-type intrauterine device placer.The difference makes sense in the statistics(P<0.05).The comparison of effectiveness The uterine cavity bleeding occurrence of testing group is less than the comparison group obviously. The difference makes great sense in the statistics(P<0.01).The states of short-term follow-up visit The distinction on the clinical effect of the capsule-type placer and the occurrence of syndrome between the testing group and the comparison group still makes no sense.Conclusion1. The degradation material and the degradation process of capsule-type intrauterine device placer is safe and without side effect. It will do not increase the occurrence of infection.2. The placing of the capsule-type intrauterine device placer is convenient. The placing process is trouble-free. The comfort and safety of the capsule-type intrauterine device placer is good.3. This capsule-type intrauterine device placer is adaptive with the hyster vertomet. It reduces the damage of uterus in degree, which will reduce the occurrence of the syndrome. The development and study of clinical application of the capsule-type intrauterine device placer is done in this paper, and the objectives are achieved. It shows that the capsule-type intrauterine device placer is feasible in clinical use. It will make great sense in the birth control field with the further study on the dedicated capsule, the system of drug implanted, and the following access.