INTERFACE MECHANICS, MATERIALS AND TISSUE RESPONSE

描述（由申请人提供）：本申请的广泛、长期目标是开发预测和治疗日间和长期残肢形状变化的方法，以减少下肢截肢患者皮肤破裂的发生。具体目的是评估在不同的插槽修改治疗，旨在克服形状变化引起的配合问题，经胫骨截肢者的界面应力稳定性。进一步的目的是更好地了解昼夜和长期形状变化的来源，并将其与残肢液体运输和其他患者组织特征相关联，这些特征可以在临床评价中进行评估。为了解决目标的流体填充细胞在控制的体积，一个均匀的厚度插入，和材料补丁固定到插座内的软组织损失的位置使用现有的界面压力和剪切应力测量系统和定制的，高分辨率，残肢扫描仪。尽管残肢形状发生了变化，但在昼夜和12个月的时间间隔内，治疗保持界面应力一致的能力被确定并与未治疗进行比较。预计对于昼夜波动：充满流体的细胞比其他治疗表现更好;保持界面应力一致的最佳细胞流体体积与残肢体积损失相匹配;并且使用流体细胞在承窝中的远端肢体运动与初始配合相同。对于长期的变化，预计需要固定到插座内部的局部材料补片和充满液体的单元来稳定界面应力。为了更好地了解残肢形状变化的生理来源，在经胫骨截肢者受试者群体上测量残肢细胞外水含量、流体运输和组织含量。预计昼夜收缩反映了细胞外水在一天中的缓慢损失。然而，预计长期收缩反映了肌肉组织含量的减少。该项目与健康有关，旨在提高截肢者的生活质量。预测和克服残肢形状变化的不利影响，并最终防止软组织破裂的方法的发展将有助于防止截肢人群的继发性残疾和发病率。

DESCRIPTION (provided by applicant): The broad, long-term objectives of this application are to develop methods to predict and treat diurnal and long-term residual limb shape changes to reduce the occurrence of skin breakdown in persons with lower-limb amputation. The specific aims are to assess interface-stress stability in trans-tibial amputee subjects under different socket-modification treatments designed to overcome fit problems induced by shape changes. A further aim is to better understand the sources of diurnal and long-term shape changes and to correlate them with residual limb fluid transport and other patient tissue characteristics that can be assessed in clinical evaluation. To address the aims fluid-filled cells at controlled volumes, a uniform-thickness insert, and material patches affixed to the inside of the socket at locations of soft-tissue loss are used with an existing interface pressure and shear stress measurement system and a custom, high-resolution, residual-limb scanner. The capabilities of the treatments to keep interface stresses consistent over both diurnal and 12-mo intervals, despite changes in residual limb shape, are determined and compared with no treatment. It is expected that for diurnal fluctuations: the fluid-filled cells perform better than the other treatments; the optimal cell fluid volume to keep interface stresses consistent matches the residual limb volume loss; and using the fluid cells distal limb movement in the socket is identical to that of the initial fit. For long-term changes, it is expected that both local material patches affixed to the inside of the socket and the fluid-filled cells are needed to stabilize interface stresses. To better understand the physiologic sources of residual limb shape change, residual limb extracellular water content, fluid transport, and tissue content are measured on a population of trans-tibial amputee subjects. It is expected that diurnal shrinkage reflects a slow loss of extracellular water over the course of the day. Long-term shrinkage, however, is expected to reflect a reduction in muscle tissue content. The health relatedness of this project is improvement in the quality of life of persons with amputated limbs. The development of methods to predict and overcome the detrimental effects of residual limb shape change and ultimately prevent soft-tissue breakdown will help to prevent secondary disability and morbidity in the amputee population.