Novel Device with Hemostatic Injection System to Control Post Biopsy Bleeding

描述（由申请方提供）：在肾脏病学中，使用传统经皮活检针与活检后出血风险相关。这导致了对替代的、更高成本的活检方法的偏好，例如开放（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器械，该器械可部署止血塞以控制活检后出血。该创新器械通过在放置过程中屏蔽止血塞来展开止血塞，从而允许将止血塞正确定位在被活检针移位的组织体积中。当活检针抽出时，塞子相对于组织保持在适当的静态位置。本提案的具体目的是设计和构建一种新型活检器械，该器械具有止血控制注射系统（CIS），该系统可部署Gelfoam（R）止血塞，同时机械控制活检针的撤回。该器械将在透明明胶中进行台架测试，随后在屠宰场猪肾中进行测试，以验证活检针和止血塞在行程长度、顺序和穿刺力方面的正确部署。将使用体内猪模型（N=2只动物），通过比较与传统活检针相比的失血量和活检组织学质量，评价CIS活检针的有效性。该I期研究的最终结果将是具有有效止血CIS机制的原型器械，证明了止血塞在体内猪模型中有效展开以控制活检后出血，为计划的II期动物研究铺平了道路，以在更大的样本量和未来的临床研究中评价替代止血剂的有效性。我们正在应对对更安全的肾活检的巨大未满足需求。该设备不仅通过显著减少开放和经颈静脉活检的需求来降低准确诊断的成本，还通过更安全的肾脏活检来实现更准确的肾脏疾病诊断，从而降低误诊的成本负担，从而降低护理成本。患者和医生将获得更多关于患者医疗状况的知识。患者对手术安全性的焦虑和对诊断不确定性的焦虑将减少。该器械和技术将为进一步开发和研究使用类似CIS机制的其他器械奠定基础，这些机制适用于需要增加安全性和控制出血以及需要控制治疗剂输送的其他临床情况。公共卫生相关性：在肾脏病学中，使用传统经皮活检针与活检后出血风险相关。这项资助将导致开发一种新型活检装置，该装置可部署止血塞以控制活检后出血。

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 The plug remains in the proper static position with respect to the tissue as the biopsy needle is withdrawn.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.