Orthopedic Tissue Tension Sensor

描述（由申请人提供）：在骨科手术中，外科医生不仅要处理骨，还要处理周围的软组织，包括肌肉、筋膜、肌腱、韧带和关节囊。这些组织的成功处理通常是高再现性、良好软组织愈合和恢复整体功能的关键。然而，没有广泛使用的、稳健的方法用于术中量化软组织张力，软组织张力是愈合中的重要变量， 整体肢体对齐。已建立的方法需要破坏软组织（例如，屈曲传感器），进入组织的自由端（例如，移植物张紧器）或了解压痕距离。目前的商业产品仅限于膝关节，不是手持式的，是侵入性的，并且测量力或负荷，但不测量张力。没有简单、无创、便宜的手持设备可以可靠、准确地量化骨科手术中的软组织张力。需要这样的装置来量化触觉反馈（“感觉”），以测量和调节开放手术中各种结构的张力，并且重要的是克服关节镜手术中有限的触觉反馈。优化和量化张力对于骨科手术的各种手术结果非常重要，可能应用于骨科手术之外（即物理治疗，整形外科，普通外科）。除了在常规手术中使用这样的工具之外，这样的工具还可以作为用于培训和重新认证的临床仪器，以及用于研究广泛的整形外科、整形外科和可能的其他外科手术的结果的研究装置。为了评估手持式传感器概念是否可行，开发并验证了手持式组织张力传感器原型。该传感器由三个圆柱形活塞组成，活塞在塑料外壳的槽中移动。槽中的轴承用于消除摩擦。虽然这种传感器的初步结果令人鼓舞，但传感器对于任何临床和商业应用来说都太大了。 因此，在第一阶段的应用中，我们将开发一种小型化的传感器探针，随后在合成和脊椎动物韧带组织中进行严格的生物力学校准和传感器功能验证。这项工作将为第2阶段应用铺平道路，以开发具有集成手柄的整个手持式传感器设备，并在临床研究中验证传感器设备功能。

DESCRIPTION (provided by applicant): In orthopedic surgery, surgeons have to handle not only bone but also the surrounding soft tissue, including muscle, fascia, tendon, ligament and capsule. Successful handling of these tissues is often the key to high reproducibility, good soft tissue healing, and restoration of overall function. However, there are no widely used, robust methods for intra-operatively quantifying soft tissue tension, an important variable in healing and overall limb alignment. Established methods require violation of the soft-tissue (e.g. buckle transducer), access to a free end of the tissue (e.g. graft tensioner) or knowledge of indentation distance. Current commercial products are limited to the knee, are not handheld, are invasive, and measure force or load, but not tension. There are no simple, non-invasive, inexpensive handheld devices available allowing to reliably and accurately quantify soft tissue tension for orthopedic surgeries. Such devices are needed to quantify tactile feedback ("feel") to measure and adjust tension of various structures in open surgeries, and importantly overcome the limited tactile feedback in arthroscopic surgeries. Optimizing and quantifying tension is important for various procedure outcomes of orthopedic surgeries, with possible applications beyond orthopedic surgery (i.e. physical therapy, plastic surgery, general surgery). Aside from using such a tool in routine surgeries, such a tool would also have applications as clinical instrument for training and recertification, as well as a research device to study outcomes in a broad range of orthopedic, plastic, and possibly other surgical procedures. To evaluate whether a hand held sensor concept is feasible, a handheld tissue tensioning sensor prototype was developed and validated. The sensor consists of three cylindrical pistons that move in slots in a plastic housing Bearings in the slots are used to eliminate friction. While the preliminary results with this senso are encouraging, the sensor is significantly too large for any clinical and commercial application. Therefore, in this phase 1 application, we will carry out the development of a miniaturized sensor probe, with subsequent rigorous biomechanical calibration and validation of the sensor function in synthetic and vertebrate ligament tissues. This effort will pave the way for a Phase 2 application to develop an entire handheld sensor device with integrated handle, and validate the sensor device function in a clinical study.