The objective of this proposal is to design, construct, and evaluate a steerable needle to debulk intracerebral hemorrhages (ICH) less invasively, from within. This is motivated by the fact that 1 in 50 people will have an ICH in their lifetime, with 40% mortality  regardless of whether surgical decompression is attempted. Despite its ability to decompress at-risk tissue, one reason surgery does not produce better overall clinical outcomes may be because of the large volume of healthy brain tissue disrupted simply to access the surgical site. To provide a means of achieving decompression more safely, we propose to create a system capable of debulking the hematoma that results from an ICH without wide exposure, through a needle-sized entry path. Our new steerable needle system will debulk the hematoma from within using a superelastic, precurved aspiration cannula that is deployed within the hematoma through a straight outer needle. The tip of this aspiration cannula is maneuvered within the hematoma by coordinated linear motion and axial rotation of both needle and cannula.
The aims of this project involve integrating steerable needle hardware with computed tomography (CT) guidance and use of a deformation model to minimize the number of CT images required, and a demonstration of the system's effectiveness in a porcine model. To achieve these aims, this project brings together a multidisciplinary team combining expertise in neurosurgery (Co-I Weaver), electromechanical design of surgical devices (PI Webster), biomechanical modeling (PI Miga), computer science (Co-I Burgner), surgical research including animal studies (Co-I Williams), and image-guided surgery (all investigators). The endpoint of this R21 project will be a successful demonstration of the complete system in an animal model, which will pave the way for future R01-funded human clinical studies.
Intracerebral hemorrhage (bleeding in the brain) strikes 1 in 50 people with 40% dying within the first month, and many more having brain damage as a result of prolonged excessive intracerebral pressure. This project focuses on creating a new steerable needle system to remove the hemorrhage with much less damage to healthy brain tissue than is required in current surgical approaches. By reducing pressure less invasively, we hypothesize that future clinical studies will show a reduction in both mortality rates and the severity of brain damage for intracerebral hemorrhage patients.