Jeans W D, Henson J H, Holloway T M, Forman A G, Blakeborough A
Department of Radiodiagnosis, University of Bristol.
Br J Radiol. 1989 Feb;62(734):121-6. doi: 10.1259/0007-1285-62-734-121.
Eight millimetre diameter angioplasty balloon catheters of both the Gruntzig and Olbert types from five manufacturers have been tested in vitro to establish bursting pressures and the changes in maximum and deflated diameters following repeated inflations, both when free and within a restraining sleeve. Maximum inflated diameters were within 10% of that stated and all types of balloon except one burst at a pressure greater than the recommended value. Deflated diameters were approximately 1 mm greater than insertion diameters, which are much smaller in the Olbert type. All balloons became a little larger with each of the first few distensions, and became stiffer. The maximum diameter was reached and remained constant after 10-15 distensions. Distension within a latex sleeve did not change bursting pressures, and it is considered that results from unconstrained testing can be extrapolated to behaviour in vivo. Computer modelling and calculation of maximum stress resultants also showed that calculated longitudinal and circumferential stresses are unaffected by applied restrictions. It is concluded that balloon technology is steadily improving and it is suggested that British Standards should be established for dilatation balloon catheters. Amongst other factors these Standards should include maximum recommended inflation pressures that are at least 2 atm less than bursting pressures, whilst the stated maximum diameter should be for fully extended balloons, and should have a tolerance of more than +/- 10%.
对来自五个制造商的Gruntzig型和Olbert型的8毫米直径血管成形术球囊导管进行了体外测试，以确定破裂压力以及在自由状态和置于约束套内重复充气后最大直径和放气直径的变化。最大充气直径在规定值的10%以内，除一种球囊外，所有类型的球囊在高于推荐值的压力下破裂。放气直径比插入直径大约大1毫米，Olbert型的插入直径要小得多。在前几次扩张中，所有球囊每次都会稍微变大，并变得更硬。在10 - 15次扩张后达到最大直径并保持不变。在乳胶套内扩张不会改变破裂压力，并且认为无约束测试的结果可以外推到体内行为。最大应力合力的计算机建模和计算也表明，计算出的纵向和周向应力不受施加的约束影响。得出的结论是球囊技术正在稳步改进，并建议应为扩张球囊导管制定英国标准。这些标准除其他因素外，应包括最大推荐充气压力，该压力至少比破裂压力低2个大气压，而规定的最大直径应为完全伸展的球囊的直径，并且应有超过+/- 10%的公差。
