Hemorrhage Control During Brain Surgery

脑部手术期间的出血控制

• 批准号: 8711596
• 负责人: Weiliam Chen
• 金额: $ 84.23万
• 依托单位: ENDOMEDIX, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-15 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8711596
• 关键词: Adhesiveness; Adhesives; Adverse effects; Africa; Animals; Biocompatible; Blood; Brain; Canis familiaris; Cephalic; Cessation of life; Chemicals; China; Chitosan; Classification; Clinical; Coagulation Process; Contracts; Development; Devices; Dextrans; Diffuse; Endotoxins; Experimental Designs; Fee-for-Service Plans; Future; Gelatin; General Anesthesia; Goals; Gold; Healthcare Systems; Hemorrhage; Hemostatic Agents; Hemostatic function; Hospitals; Hour; Hydrogels; In Situ; India; Injury; Insurance Carriers; Japan; Label; Lead; Ligature; Longevity; Manuals; Manufacturer Name; Marketing; Mediating; Methodology; Methods; Modeling; Molecular Weight; Morbidity - disease rate; Operating Rooms; Operative Surgical Procedures; Performance; Phase; Pilot Projects; Preparation; Price; Privileged Communications; Process; Production; Protocols documentation; Recovery; Risk; Russia; Sahara; Site; Solutions; Speed; Staging; Structure; Suction; Surgeon; Swelling; System; Techniques; Testing; Thrombin; Time; Tissues; Toxicology; Validation; Viscosity; Work; absorption; biomaterial compatibility; brain surgery; cost; design; dextran; disease transmission; health care economics; improved; in vivo; interest; neurosurgery; payment; pre-clinical; pressure; prototype; public health relevance; research study

DESCRIPTION (provided by applicant): Bleeding control during brain surgery is of utmost importance, as uncontrolled bleeding inside the confined intracranial space can quickly degenerate into debilitating complications and death. Ligature is usually not possible in the brain due both to the small size of the vessels and the delicacy of the tissue as the majority of bleedings during neurosurgery is the topical diffuse/oozing type bleeding. The methods for bleeding control during brain surgery has practically not changed for decades; surgical aids that work by pressure, absorption, and/or chemical mediated mechanisms are deployed for hemostasis during brain surgery. The shortcomings of these products include: (i) require preparation, (ii) non-conformal/non-adhesive to the surgical site, (iii) require manual pressure, (iv) lack transparency - limited capacity to visualize the hemostasis status, (v) materials of bloo and/or mammalian origin - risk of disease transmission, and (v) swelling. Importantly, the major inadequacies of these products are slow acting leading to prolonging surgery (risk and morbidity) and often produce inconsistent results. Gelatin foam saturated with thrombin solution in conjunction with applying pressure is still the current gold-standard to stop diffuse bleeding; the process requires a coordinated deployment of at least four products including gelatin foam, thrombin, cottonoids, and suction. We are developing a non-mammalian/non-blood derived biocompatible and biodegradable, in situ gelable adhesive/formable/conformable and non-swelling transparent hydrogel that requires no preparation, for cranial hemostasis, it is non-chemically mediated and can quickly stop bleeding on contact without any adjuncts. [A transparent agent, capable of achieving hemostasis rapidly, enables the surgeons to determine the status of hemostasis and speed up the decision of moving onto the next step of the surgery.] Accelerating surgery with a highly competitively priced hemostatic agent will eventually result in considerable cost saving on operating room time and reduction of morbidity through shortening of surgery and general anesthesia. Our product conforms to the new healthcare economics where insurers are increasingly demanding superior products at lower costs. A prototype agent was developed in the Phase I of this project and its efficacy and performance criteria have been experimentally defined. In Phase II, we will continue to develop the hemostat product. The major goals are: (i) reduce the product endotoxin burden to comply with FDA's requirement, (ii) maximize the product's consistency, (iii) streamline the current methodologies to reduce the future production costs, (iv) develop a non-power assisted dispenser for the product to facilitate clinical use, (v) production of GLP grade materials, (vi) ISO10993 biocompatibility and toxicology validation, and (vii) in vivo pilot testing of the hemostat in a large animal cranial model.

描述(申请人提供)：在脑外科手术中控制出血是非常重要的，因为在有限的颅内空间内不受控制的出血会迅速恶化为使人衰弱的并发症和死亡。在大脑中通常不可能结扎 神经外科手术中的出血多为局部弥漫性/渗出型出血，这既是由于血管的细小，又是组织的微妙。脑外科手术中控制出血的方法几十年来几乎没有改变；在脑外科手术中使用通过压力、吸收和/或化学中介机制起作用的手术辅助设备来止血。这些产品的缺点包括：(I)需要准备，(Ii)非适形/非粘连到手术部位，(Iii)需要手动施压，(Iv)缺乏透明度有限的能力来观察止血状态，(V)血液和/或哺乳动物来源的材料-疾病传播的风险，以及(V)肿胀。重要的是，这些产品的主要不足是作用缓慢，导致手术时间延长(风险和发病率)，并经常产生不一致的结果。用凝血酶溶液饱和的明胶泡沫结合施压仍然是目前阻止弥漫性出血的黄金标准；这一过程需要协调部署至少四种产品，包括明胶泡沫、凝血酶、类棉和抽吸。我们正在开发一种非哺乳动物/非血液来源的生物相容性和生物降解性、原位胶粘剂/可成形/顺应性和不肿胀的透明水凝胶，不需要任何准备，对于颅骨止血，它是非化学介导性的，可以在接触时快速止血，而不需要任何附件。[一种能够快速止血的透明试剂，使外科医生能够确定止血状态，并加快决定进入下一步手术。]使用价格极具竞争力的止血剂加速手术，最终将通过缩短手术和全身麻醉来节省手术室时间并减少并发症。我们的产品符合新的医疗保健经济，在这种经济中，保险公司越来越要求以更低的成本提供优质的产品。在该项目的第一阶段中开发了一种原型药剂，并通过实验确定了其药效和性能标准。在第二阶段，我们将继续开发止血产品。主要目标是：(I)减少产品内毒素负担以符合FDA的要求，(Ii)最大限度地提高产品的一致性，(Iii)简化当前的方法，以降低未来的生产成本，(Iv)为产品开发一种非动力辅助分配器，以方便临床使用，(V)生产GLP级材料，(Vi)ISO10993生物兼容性和毒理学验证，以及(Vii)在大型动物颅骨模型上进行体内试验测试止血器。