Novel Fibrin Sealant Delivery for Intracranial Hypotension

Student Team: FibrinOne 

Gloria Chan, Chloe Collins, Nathan Odonkor, Michael Pang, and Despina Pavlidis

Sponsor:

Sumir Patel, MD, MBA,  Emory University Hospital

  

 

Project Description: 

Cerebrospinal fluid leaks through the dura mater surrounding the spinal cord affect nearly 100,000 people annually and are a debilitating condition characterized by a drastic decrease in quality of life. With reimbursements of $5000 per procedure and fibrin sealant costing an average of $500, the estimated total available market and serviceable available market is $376 million and $177 million, respectively. The current intervention involves administering an epidural blood patch with the patient’s autologous blood; however, these patients will receive 1.3 repeat procedures on average. Recent advances have identified fibrin glue injection as a more efficacious procedure due to the lower rate at which it is degraded, but there is currently no FDA-cleared device intended for the delivery of fibrin glue into the epidural space. Despite this, physicians are still devising alternative ways to deliver fibrin glue as an off-label use. The central flaw in the current implementation of fibrin glue delivery is due to the simultaneous delivery of fibrinogen and thrombin. While these components individually are very fluid, direct contact results in rapid polymerization into a firm hydrogel which can easily occlude a large gauge needle. FibrinOne proposes a novel delivery method of fibrin glue to the epidural space by eliminating the direct contact of fibrinogen and thrombin in the needle lumen through a saline flush component. The product utilizes one common plunger to independently and sequentially dispense all components in discrete amounts with a spring system. The trio syringe will decrease the occurrences of needle occlusion which will in turn decrease tissue trauma because needle reinsertions will not be necessary. As reinsertions are not required, procedure times will decrease, allowing a higher patient turnover rate. As more fibrin glue treatments are conducted there will be a decrease in the number of repeat treatments due to fibrin glue’s higher efficacy.

 

 

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