Wong Philip, Johnson Kent J, Warner Roscoe L, Merz Scott I, Kruger Grant H, Weitzel William F
MC3, Inc., 3526 West Liberty, Suite 100 , Ann Arbor, MI 48103 e-mail:
J Med Device. 2013 Mar;7(1):110021-110027. doi: 10.1115/1.4023274. Epub 2013 Feb 4.
Renal disease is epidemic in the United States with approximately 8 × 10 people having chronic kidney disease. Renal biopsies are widely used to provide essential diagnostic information to physicians. However, the risk of bleeding complications possibly leading to life-threatening situations results in the contra-indication of biopsy in certain patient populations. Safer renal biopsies will allow more accurate diagnosis and better management of this epidemic health problem. We report the preclinical testing of a novel biopsy device called the therapeutic injection system (TIS). The device introduces a third stage to the standard two-stage side-cut percutaneous biopsy process. The third stage is designed to reduce bleeding complications by injecting a hemostatic plug at the time of biopsy. Laboratory evaluation and preliminary in vivo animal testing using an anticoagulated porcine model of the TIS and Bard Monopty (Bard Medical, Covington, GA) control device were performed. The hemostatic material Gelfoam (Pfizer, Brussels, Belgium) was selected as the active material comprising the hemostatic plugs. The performance of two composite plugs, one composed of polyvinyl alcohol (PVA) combined in 2:1 and 12:1 ratios with the hemostatic material, and one plug composed of 100[Formula: see text] hemostatic material were tested. Stroke sequence and hemostatic plug deployment were verified by sequential firing of the TIS biopsy needle into clear gelatin and ex vivo bovine kidney specimens. In vivo trials with porcine specimens revealed a significant reduction in blood loss (8.1 [Formula: see text] 3.9 ml, control versus 1.9 [Formula: see text] 1.6 ml, 12:1 PVA/hemostatic, TIS, [Formula: see text] = 0.01, [Formula: see text] = 6). The 100[Formula: see text] hemostatic plug showed a substantial and immediate reduction in blood loss (9.2 ml, control versus 0.0 ml, TIS, [Formula: see text] = 1). The prototype device was shown to work repeatedly and reliably in laboratory trials. Initial results show promise in this approach to control post biopsy bleeding. This solution maintains the simplicity and directness of the percutaneous approach, while not significantly changing the standard percutaneous biopsy procedure.
在美国，肾脏疾病十分普遍，约有8×10人患有慢性肾病。肾活检被广泛用于为医生提供重要的诊断信息。然而，出血并发症的风险可能导致危及生命的情况，这使得在某些患者群体中肾活检成为禁忌。更安全的肾活检将有助于更准确地诊断和更好地管理这一普遍存在的健康问题。我们报告了一种名为治疗性注射系统（TIS）的新型活检装置的临床前测试。该装置在标准的两阶段侧切经皮活检过程中引入了第三阶段。第三阶段旨在通过在活检时注射止血栓来减少出血并发症。使用TIS的抗凝猪模型和Bard Monopty（Bard Medical，Covington，GA）对照装置进行了实验室评估和初步体内动物测试。止血材料Gelfoam（辉瑞，布鲁塞尔，比利时）被选为构成止血栓的活性材料。测试了两种复合栓，一种由聚乙烯醇（PVA）与止血材料按2:1和12:1的比例混合而成，另一种栓由100%止血材料组成。通过将TIS活检针依次刺入透明明胶和离体牛肾标本，验证了行程顺序和止血栓的部署。对猪标本的体内试验显示，失血量显著减少（对照组为8.1±3.9毫升，12:1 PVA/止血材料的TIS组为1.9±1.6毫升，P = 0.01，n = 6）。100%止血栓显示失血量大幅且立即减少（对照组为9.2毫升，TIS组为0.0毫升，P = 1）。该原型装置在实验室试验中显示出可重复且可靠地工作。初步结果表明这种控制活检后出血的方法很有前景。该解决方案保持了经皮方法的简单性和直接性，同时没有显著改变标准的经皮活检程序。
