Novel Device with Hemostatic Injection System to Control Post Biopsy Bleeding

具有止血注射系统的新型装置可控制活检后出血

• 批准号: 7744963
• 负责人: William F Weitzel
• 金额: $ 9.49万
• 依托单位: MC3, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-01 至 2011-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7744963
• 关键词: Abattoirs; Absorbable Gelatin Sponge; Animals; Anxiety; Biopsy; Blood Volume; Cannulas; Caring; Clinical; Clinical Research; Complication; Development; Devices; Diagnosis; Diagnostic; Family suidae; Future; Gelatin; Grant; Hematoma; Hemorrhage; Hemostatic Agents; Histologic; Imagery; Incidence; Injection of therapeutic agent; Kidney; Kidney Diseases; Knowledge; Left; Length; Measures; Mechanics; Medical; Methods; Metric; Modeling; Needle biopsy procedure; Needles; Nephrology; Normal tissue morphology; Operative Surgical Procedures; Patients; Penetration; Phase; Phase I Clinical Trials; Physicians; Pliability; Plug-in; Polymers; Positioning Attribute; Procedures; Resistance; Risk; Safety; Sample Size; Stroke; Structure; System; Technology; Testing; Therapeutic Agents; Tissues; Uncertainty; United States; Vertebral column; Withdrawal; Work; cost; design and construction; in vitro testing; in vivo; innovation; notch protein; novel; performance tests; preference; prototype; public health relevance; success

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 The plug remains in the proper static position with respect to the tissue as the biopsy needle is withdrawn.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

描述(申请人提供)：在肾脏病中，使用常规的经皮活检针头与活检后出血的风险有关。这导致了对替代的、成本较高的活检方法的偏好，如开放(外科)活检和经颈静脉活检。我们正计划设计、建造和测试一种新型的活检装置，该装置使用止血塞来控制活检后的出血。这一创新的设备通过在放置期间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。当抽出活检针时，塞子相对于组织保持在适当的静止位置。这项建议的具体目的是设计和建造一种带有止血控制注射系统(CIS)的新型活组织检查设备，该系统使用明胶海绵(注册商标)止血塞子，同时机械控制活组织检查针的取出。该设备在透明明胶中进行台式测试，随后在屠宰场猪肾脏中进行测试，以验证活检针和止血塞在行程长度、顺序和穿透力方面的正确部署。一个活体猪模型(N=2只动物)将被用来评估CIS活检针的有效性，方法是将失血量与传统活检针的失血量和活检的组织质量进行比较。这项第一阶段研究的最终结果将是一个具有有效止血CIS机制的原型设备，展示了在活体猪模型中有效地部署止血塞来控制活组织检查后出血，为计划中的第二阶段动物实验铺平道路，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效果。我们正在应对对更安全的肾脏活检的巨大未得到满足的需求。这一设备不仅将通过大幅减少开放和经颈静脉活检的需求来降低准确诊断的成本，还将通过更安全的肾脏活检来实现对肾脏疾病的更准确诊断，从而降低护理成本，从而减少误诊的成本负担。患者和医生将被提供更多关于患者健康状况的知识。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。这项设备和技术将为进一步开发和研究使用类似的CIS机制的其他设备奠定基础，这些设备适用于其他临床情况，在这些情况下，需要更高的安全性和出血控制，以及需要控制治疗剂的输送。公共卫生相关性：在肾脏科，常规经皮活检针头的使用与活检后出血的风险有关。这笔赠款将导致开发一种新的活检设备，该设备部署止血塞来控制活检后出血。