Dibie A, Musset D, Bougaran J, Girard P, LaBorde F
Centre Médico-Chirurgical de la Porte de Choisy, Paris.
Phlebologie. 1993 Jul-Sep;46(3):449-55.
a 7 F percutaneous cava filter was achieved, developed and tested in a goat. Thanks to its double-spiral original form, it is possible to place and remove it atraumaticaly and percutaneously. PRINCIPLES OF THE FILTER: its diameter, larger than the lower vena cava's (LVC) leads to a flattening of the venous lumen whose flow is intersected by the filter turns, thus creating a netting effect.
CASE-REPORT: during 28 months, 40 filters were introduced under fluorscopy in 20 goats. Thanks to 16 embolizations, it was possible to test the effectiveness of the filter against small emboli, with simultaneous cavography and pulmonary angiography in 4 cases. 29 filters were removed by jugular and femoral track, from D0 to D14. 12 goats were sacrificed to investigate histologicaly and macroscopicaly the LVC and control the biocompatibility from the 8th to the 385th day. Clinical and radiological supervision lasted more than one year for 3 goats.
the size of the filter (30, 35, 40 mm) is chosen from the LVC diameter measured by cavography. 30 filters were introduced via jugular vein, 10 via femoral vein. These filters were introduced by catheter 7F thanks to an applicator and placed in correct position in the LVC. RELIABILITY OF THE FILTER: easy percutaneous introduction 7F. Once installed, the filters flatten the LVC; this process is automatically confirmed by cavography, and by scanning in 4 cases. EFFECTIVENESS AGAINST EMBOLI: out of 16 cases, 2 partial failures were observed at the beginning of the experiment (one spiral-fitted filter). Its effectiveness was optimized thanks to the addition of a second spiral which allowed the blocking of over-2 mm clots. PERCUTANEOUS REMOVAL: during the initial removals, partial failures were due to the fragility of the filter and the inflexibility of the extracting material. Successive changes of the shape and the alloy of the filter as well as the development of catheters and extracting materials have led to a sufficient reliability to remove (D0 to D14) the filter in security, by percutaneous tract (9 jugular, 9 femoral) before its clamping on the LVC, on the 15th day. INNOCUOUSNESS: both biological supervision and anatomo-pathological investigation have showed the good tolerance of the filter. In local areas, this atraumatic filter does not wound nor perforate the LVC wall. Histologically, a thickening of the intima is observed. The positive results of this experiment led us to start clinical trials of "DM" filter in human beings.
在山羊身上研制并测试了一种7F经皮腔静脉滤器。由于其独特的双螺旋形状，能够经皮无创地放置和取出。滤器原理：其直径大于下腔静脉（LVC），导致静脉腔扁平，滤器的螺旋圈使血流受到干扰，从而产生网捕效应。
在28个月内，对20只山羊进行了荧光透视引导下的40次滤器植入。通过16次栓塞，在4例中同时进行腔静脉造影和肺血管造影，从而测试滤器对小栓子的有效性。在第0天至第14天，通过颈静脉和股静脉路径取出29个滤器。对12只山羊进行了宰杀，在第8天至第385天对LVC进行组织学和大体检查，以评估生物相容性。对3只山羊进行了超过一年的临床和放射学监测。
根据腔静脉造影测量的LVC直径选择滤器尺寸（30、35、40毫米）。30个滤器经颈静脉植入，10个经股静脉植入。借助7F导管和应用器将这些滤器正确放置在LVC中。滤器可靠性：易于经皮7F导入。安装后，滤器使LVC扁平；这一过程通过腔静脉造影自动确认，4例通过扫描确认。抗栓子有效性：在16例中，实验开始时观察到2例部分失败（一个螺旋适配滤器）。由于增加了第二个螺旋，使直径超过2毫米的血栓得以阻断，从而优化了其有效性。经皮取出：在最初的取出过程中，部分失败是由于滤器易碎和取出材料缺乏柔韧性。滤器形状、合金的相继改变以及导管和取出材料的改进，使在第15天滤器夹闭LVC之前，通过经皮路径（9条颈静脉、9条股静脉）安全取出滤器具有足够的可靠性。无害性：生物学监测和解剖病理学研究均表明滤器具有良好的耐受性。在局部区域，这种无创滤器不会损伤也不会穿透LVC壁。组织学上，观察到内膜增厚。该实验的阳性结果促使我们开始在人体上进行“DM”滤器的临床试验。
