Research Project
9066889
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.
