Wearable muscle fiber excitation system for preventing blood clot

描述（由申请人提供）：该I期SBIR项目的目的是设计、开发和评价一种可穿戴肌纤维兴奋系统（MFES），用于预防下肢矫形手术后恢复期固定患者的血凝块。MFES器械将源自手持式模型的重新设计，包括嵌入专门设计的可调节肢体支具隔室中的专门设计的微型振动器。作为手持式模型，MFES预期在循环旋转中提供20 Hz至130 Hz的激发刺激频带。应用于肢体，肢体慢和快收缩肌肉纤维将在每个收缩频率下同时B激励以募集被削弱的肌肉收缩。预期长时间MFES操作会导致肌肉节律性收缩和释放，从而导致血管节律性压缩和释放。这种表现预计会增加肢体血液转移，因为刺激会传播到远端解剖位置，防止血液流动 合伙该项目的长期目标是临床前和临床研究，以确定MFES的疗效，有助于临床管理，以防止由于年龄或疾病或骨科手术后不动而导致的外周血池和凝块。在第一阶段SBIR项目中，我们将 从我们的大规模模型中开发MFES原型，并评估MFES在肌纤维抽搐频率下提供兴奋刺激的技术性能，对血流和肌肉电活动的影响。研究方法：我们将提供一个手持模型的研究专业在静脉疾病和实验的医生和物理治疗教授与研究专业在人类的表现进行实验，并提供建议MFES功能的意见，从实验与手持模型。我们将在MFES零部件、随附专用肢体支具和用于将微振动能量传输至人体肢体的人体界面部分的SolidWorks工程设计中纳入他们的临床意见。我们将在SolidWorks中生成每个零部件的真实实体模型（STL）。通过与OEM Fabricators Inc.合作，我们将使用计算机辅助制造来生产STL提供的零件，并获得其余的零部件。我们将按照设计组装零件以生产MFES原型。我们将使用我们的测试夹具，通过分析安装在与MFES接触的测试夹具上的加速度计的输出信号，对MFES提供的拟议激励刺激进行技术评估。通过与临床研究人员签订合同，我们将进行有限的概念验证试点人体研究，以：A）通过比较有和没有刺激输送的表面肌肉肌电图（SEMG）来确定MFES兴奋刺激是否会引起更大的肌肉电活动，以及B）通过比较刺激输送前后的血流来确定下肢血流是否更多地归因于MFES刺激输送。在MFES刺激输送之前和期间，将使用连接到胫骨和股骨肌肉群的BiometricsTM表面电极和BiometricsTM便携式数据采集系统采集SEMG。在MFES激发刺激输送之前和之后1分钟和10分钟，将使用Hokanson的照片和应变仪体积描记器采集针对肢体外周动脉和静脉的血流数据。将处理SEMG数据以确定平均值，并将使用Hokanson分析软件处理血流数据以确定动脉和静脉指数。重复测量ANOVA将用于分析处理后的SEMG数据，以确定刺激输送期间MFES刺激的效果以及刺激输送前后MFES的效果。将在SPSS 13.0中进行统计分析。在5%的显著性水平下进行双尾检验。据我们所知，这是第一次提出这种方法。

DESCRIPTION (provided by applicant): The objective of this Phase I SBIR project is to design, develop and evaluate a wearable Muscle Fiber Excitation System (MFES) for preventing blood clot in immobilized patients during convalescence following lower limb orthopedic surgery. The MFES device will be derived from re-design of a hand-held model to comprise of specially- designed micro vibrators embedded in compartments of specially-designed adjustable limb brace. As the hand-held model, the MFES is expected to deliver excitation stimuli band 20Hz to 130Hz in a cyclic revolution. Applied to a limb, the limb slow and fast-twitch muscle fibers will b concurrently energized at each twitch frequency to recruit enervated muscle contractions. Prolonged MFES operation is expected to cause rhythmic muscle contraction and release resulting in rhythmic compression and release of blood vessels. This performance is expected to increase limb blood shift, with the spread of stimuli to distal anatomic locations prevent blood pooling. The project's long term objectives are pre-clinical and clinical studies to determine MFES efficacy contributing to clinical management to prevent peripheral blood pooling and clots due to age or illness or immobility after orthopedic surgery. In this Phase I SBIR project, we will develop prototypes of MFES from our large scale model and evaluate MFES technical performance in delivering excitation stimuli at muscle fiber twitch frequencies, the effects on blood flow and muscle electrical activities. Methods: We will provide a hand-held model to a medical doctor with research specialty in vein disease and experiments and a Physical Therapy Professor with research specialty in human performance to experiment and provide comment on MFES features as proposed, drawing from experimentation with the hand-held model. We will incorporate their clinical comments in SolidWorks engineering design of the MFES component parts, the accompanying special limb brace, and the human interface section for transmitting the micro vibration energy to the human limb. We will generate in SolidWorks, realistic solid models, (STL) of each component part. In partnership with OEM Fabricators Inc, we will use computer-aided manufacture to produce STL provided parts, and acquire the rest of the component parts. We will assemble the parts as designed to produce MFES prototypes. We will use our test jig for technical evaluation of MFES delivery of the proposed excitation stimuli by analyzing output signals from accelerometer mounted on the test jig that makes contact with the MFES. Through contract with the clinician researchers we will conduct limited proof of concept pilot human studies to: A) determine whether MFES excitation stimuli cause greater muscular electrical activities by comparing surface muscle electromyogram (SEMG) with and without stimuli delivery, and B) determine if lower limb blood flow is more due to MFES stimuli delivery by comparing blood flow before and after stimuli delivery. SEMG will be acquired with BiometricsTM surface electrodes connected to the tibia and femur muscle groups and BiometricsTM portable data acquisition system before and during MFES stimuli delivery. Blood flow data will be acquired with Hokanson's Photo and Strain Gauge plethysmograph targeting limb peripheral arteries and veins before and, 1 minute and 10 minutes after MFES excitation stimuli delivery. SEMG data will be processed to determine mean values, and blood flow data will be processed with Hokanson analysis software to determine arterial and venous indices. Repeated measures ANOVA will be used to analyze processed SEMG data to determine the effect of MFES stimulation during stimuli delivery, and the effect of MFES before and after stimuli delivery. Statistical analysis will be conducted in SPSS 13.0. Tests will be two tailed at 5% level of significance. To the best of our knowledge, this is the first time this approach has been proposed.