SBIR-STTR Award

Endoscopic techniques are revolutionizing many surgical procedures and further expansion is inevitable. The essence of minimally invasive surgery is to operate in a dry field, avoiding major hemorrhage, which can force conversion of the endoscopic approach to a laparotomy. Electrosurgical devices fulfill the need for tissue cutting with simultaneous vascular coagulation in a cost- effective manner. However, monopolar systems can conduct current along unwanted pathways through the patient and cause tissue damage. Safety concerns and intensified by the limited field of view. Recently, bipolar scissors have been developed, which address the safety concerns. But, the scissors are limited by incompatibility with many generators, mechanical complexity, slow or ineffective coagulation, relatively high cost to manufacture, and loss of feel for the surgeon who is accustomed to conventional "metal to metal" cutting surfaces. To overcome these limitations, the PI has devised a new type of bipolar scissors, in which, each blade is a bipolar electrode. This design allows for multiple local current pathways, high current densities, and lower impedance. These scissors should work with most generators, have greater coagulation efficiency, and higher cutting speeds. In Phase I, the principal investigator proposes to fabricate, test, and compare the bipolar scissors with other monopolar and bipolar scissors in benchtop and in acute in vivo studies.

Thesaurus Terms:
biomedical equipment development, clinical biomedical equipment, electrode, endoscopy MammaliaNational Heart, Lung and Blood Institute (NHLBI)

Endoscopic techniques are revolutionizing surgery and further expansion is inevitable. Minimally invasive surgery requires a dry operating field to avoid major hemorrhage. Electrosurgical devices fulfill the need for cutting and coagulation in a cost-effective manner. However, monopolar systems can conduct current along unwanted pathways and cause tissue damage. Although recently developed bipolar scissors address safety concerns, the scissors are limited by slow or ineffective coagulation, relatively high cost to manufacture, and loss of 'feel' for the surgeon who is accustomed to 'metal to metal' cutting surfaces. Thus, in Phase l, we developed, built and tested new bipolar scissors, in which each blade is a bipolar electrode. This design allows for multiple local current pathways. In benchtop and in-vivo experiments, the Enable scissors had superior characteristics compared with other bipolar scissors; i.e., higher current densities, lower impedance, and greater coagulation efficiency. In Phase II, we will complete the development of the Enable scissors and compare the Enable bipolar scissors with other devices in benchtop and in acute and chronic in-vivo studies. The superior performance of the Enable scissors will improve patient care. In Phase III, similar to our current approach, we will market these scissors both nationally and internationally. PROPOSED COMMERCIAL APPLICATIONS: Our newly designed bipolar scissors will overcome the limitations of current bipolar scissors. The scissors would help to expand endoscopic surgery, and thus, improve patient care. The endoscopic market is a rapidly growing segment, having a growth rate of over 20%/year with total instrument sales exceeding $1 billion annually.