Novel Device with Hemostatic Injection System to Control Post Biopsy Bleeding

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 The plug remains in the proper static position with respect to the tissue as the biopsy needle is withdrawn.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