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Development of a ceramic heart valve

陶瓷心脏瓣膜的研制

基本信息

批准号：
60870045
负责人：
MITAMURA Yoshinori
金额：
$ 6.34万
依托单位：
Hokkaido University
依托单位国家：
日本
项目类别：
Grant-in-Aid for Developmental Scientific Research
财政年份：
1985
资助国家：
日本
起止时间：
1985 至 1986
项目状态：
已结题

来源：
https://kaken.nii.ac.jp/en/grant/KAKENHI-PROJECT-60870045/
关键词：
Artificial Heart Valve Ceramics Alumina Titanium Nitride 抗血栓性人工弁単結晶アルミナ

项目摘要

A durable, thromboresistant tilting flat disk-type valve was developed. It is comprised of a thin (0.6 mm) single-crystal alumina ceramic disk and titanium nitride housing. The housing was milled from a single piece of titanium and coated with titanium nitride by ion plating.(1) Critical surface tension was 32 dyne/cm for titanium nitride, and 26 dyne/cm for single crystal alumina and LTI carbon. These are nearly equal to the value of 20-30 dyne/cm in which the critical surface tensions of most blood compatible biomaterials range.(2) The single-crystal alumina and titanium nitride showed excellent blood compatibility in vena cava ring tests. Two weeks after implantation one alumina ring showed no thrombi, and the other 4 rings showed a small amount of clot formation at the edges. Three titanium nitride rings showed no thrombi, and the other 2 rings showed a small amount of clot formation at the edges after 2 weeks.(3) Durability testing under high pressure ( up to 1750 mmHg) pulsatile conditions showed that the safety factor appears to be at least 7 times what could be experienced in vivo.(4) Pin on disk wear testings were conducted for measuring the wear rates of the single-crystal crystal alumina and titanium nitride. The wear factor of titanium nitride ( vs single crystal alumina ) was 1.8 X <10^(-7)> <mm^3> /Nm, which would indicate a long life of the valve.(5) The pressure gradient of the ceramic valve was lower than that of the Bjork-Shiley, and nearly equal to those of the Omni-Science and SJM valves. The opening time of the valve disk was measured by optical sensor. The ceramic valve opened most quickly among commercially available valves.(6) The ceramic valve was incorporated into a pneumatic assist pump as an outflow valve and was implanted in 2 sheep. After 5 days, no thrombi were observed on the ceramic valves although a thrombus was found on the conventional valves used as an inflow valve.The ceramic valve is a promising heart valve.

开发了一种耐用、抗血栓的倾斜平板阀。它由薄（0.6 mm）单晶氧化铝陶瓷盘和氮化钛外壳组成。外壳由单片钛铣削而成，并通过离子镀涂覆氮化钛。(1)氮化钛的临界表面张力为32达因/厘米，单晶氧化铝和LTI碳的临界表面张力为26达因/厘米。这些几乎等于20-30达因/厘米的值，其中大多数血液相容性生物材料的临界表面张力范围。(2)单晶氧化铝和氮化钛在腔静脉环测试中显示出优异的血液相容性。植入后2周，1个氧化铝环未显示血栓，其他4个环边缘显示少量凝块形成。3个氮化钛环显示无血栓，另外2个环在2周后边缘显示少量凝块形成。(3)在高压（高达1750 mmHg）脉动条件下的耐久性试验表明，安全系数似乎至少是体内安全系数的7倍。(4)进行销盘磨损试验以测量单晶氧化铝和氮化钛的磨损率。氮化钛的磨损系数（相对于单晶氧化铝）为1.8 × 10 - 7 mm 3/Nm，这表明阀的寿命较长。(5)陶瓷瓣膜的压力梯度低于Bjork-Shiley瓣膜，几乎等于Omni-Science和SJM瓣膜。采用光学传感器测量阀盘的开启时间。陶瓷阀在市售阀中打开最快。(6)将陶瓷阀作为流出阀纳入气动辅助泵中，并植入2只绵羊体内。5天后，陶瓷瓣膜上未观察到血栓，而作为流入道瓣膜的传统瓣膜上发现血栓，陶瓷瓣膜是一种有前途的心脏瓣膜。