Novel Device with Hemostatic Injection System to Control Post Biopsy Bleeding

描述（由申请人提供）：在肾脏病学中，使用传统的经皮活检针与活检后出血的风险相关。这导致人们倾向于选择其他成本更高的活检方法，如开放（手术）活检和经颈静脉活检。我们正计划设计、构建和测试一种新型活检设备，该设备部署止血栓来控制活检后出血。这种创新的装置通过在放置过程中屏蔽止血塞，从而使止血塞在被活检针移位的组织体积中正确定位。当活检针拔出时，塞子相对于组织保持在适当的静态位置。本提案的具体目标是设计和构建一种新型活检装置，该装置带有止血控制注射系统（CIS），该系统部署凝胶泡沫(R)止血塞，同时机械控制活检针的取出。该装置在透明明胶中进行了台架测试，随后在屠宰场的猪肾中进行了台架测试，以验证活检针和止血塞在笔划长度、顺序和穿透力方面的正确部署。将使用活体猪模型（N=2只动物），通过比较CIS活检针与常规活检针的失血量和活检组织质量来评估CIS活检针的疗效。I期研究的最终结果将是一个具有有效止血CIS机制的原型装置，在猪体内模型中证明止血栓的有效部署，以控制活检后出血，为计划中的II期动物研究铺平道路，以在更大的样本量和未来的临床研究中评估替代止血剂的功效。我们正在应对对更安全的肾脏活检的巨大未满足需求。该设备不仅将通过大幅减少开放和经颈静脉活检的需要来降低准确诊断的成本，还将通过更安全的肾脏活检来更准确地诊断肾脏疾病，从而降低护理成本，减少误诊的成本负担。病人和医生将获得更多关于病人医疗状况的知识。患者对手术安全性的焦虑和对诊断不确定性的焦虑将会减少。该设备和技术将为进一步开发和研究使用类似CIS机制的其他设备奠定基础，这些设备适用于需要提高安全性和控制出血以及需要控制治疗药物递送的其他临床情况。公共卫生相关性：在肾脏病学中，使用传统的经皮活检针与活检后出血的风险相关。这笔拨款将用于开发一种新型活检设备，该设备可部署止血栓来控制活检后出血。

DESCRIPTION (provided by applicant): In nephrology, the use of conventional percutaneous biopsy needles is associated with the risk of post biopsy bleeding. This has resulted in a preference for alternate, higher cost biopsy methods such as open (surgical) biopsy and transjugular biopsy. We are planning to design, construct and test a novel biopsy device that deploys a hemostatic plug to control post biopsy bleeding. This innovative device deploys the hemostatic plug by shielding it during the placement allowing the proper positioning of the plug in the tissue volume being displaced by the biopsy needle. The plug remains in the proper static position with respect to the tissue as the biopsy needle is withdrawn. The specific aims for this proposal are the design and construction of a novel biopsy device with a hemostatic Control Injection System (CIS) that deploys a hemostatic plug of Gelfoam(R) concomitant with mechanically controlled withdrawal of the biopsy needle. The device with be bench tested in clear gelatin and subsequently in slaughterhouse porcine kidneys to verify proper deployment of the biopsy needle and hemostatic plug with respect to stroke length, sequence and penetration force. An in-vivo porcine model (N=2 animals) will be used to evaluate the efficacy of the CIS biopsy needle by comparing blood volume lost against a conventional biopsy needle and the biopsies' histological quality. The end result of this Phase I study will be a prototype device with working hemostatic CIS mechanism demonstrating effective deployment of a hemostatic plug to control post biopsy bleeding in an in-vivo porcine model paving the way to planned Phase II animal studies to evaluate the efficacy of alternate hemostatic agents in a larger sample size and future clinical studies. We are responding to tremendous unmet need for safer kidney biopsies. This device will not only reduce the cost of accurate diagnosis by dramatically decreasing the need for open and transjugular biopsies, it will reduce the cost of care by allowing more accurate diagnosis of renal diseases through safer kidney biopsies, decreasing the cost burden of misdiagnosis. The patient and practitioner will be afforded greater knowledge about the patient's medical condition. Patient anxiety about the safety of the procedure and the anxiety about uncertainty of diagnosis will be reduced. This device and technology will lay the groundwork for further development and study of additional devices using similar CIS mechanisms applicable to other clinical situations where increased safety and control of bleeding are desired and where controlled delivery of therapeutic agents are needed. PUBLIC HEALTH RELEVANCE: In nephrology, the use of conventional percutaneous biopsy needles is associated with the risk of post biopsy bleeding. This grant will result in the development of a novel biopsy device that deploys a hemostatic plug to control post biopsy bleeding.