Project Summary/Abstract: The objective of this proposal is to create a new surgical robot to enable women who currently face the life- long consequences of hysterectomy to have minimally invasive, uterine-sparing interventions. The robot will deliver needle-sized instruments through an endoscope, enabling independent tissue manipulation, electrosur- gical probe movement, and visualization, facilitating more precise, accurate, and efficient intrauterine surgery. Clinical significance comes from the fact that over 50,000 women per year will lose their uterus to fibroids that elite surgeons have demonstrated can be removed endoscopically. Instrument dexterity limitations prevent typical surgeons from offering uterine-sparing endoscopy to these women. This results in only 1 in 10 women benefiting from the minimally invasive endoscopic approach while 2 in 3 face the lifelong negative consequences of hysterectomy. Our innovation is to provide the surgeon with two miniature robotic instruments delivered through the endo- scope, to enhance dexterity and enable two-handed retraction and resection. These instruments are made from telescoping, curved, elastic tubes. By axially rotating and telescopically extending the tubes, our robot will provide the surgeon with two tentacle-like instruments small enough to be delivered through standard-sized endoscopes. These instruments, combined with a variable view angle optic, will enable lateral dexterity and visualization, countertraction, and accurate and efficient tissue resection. Our approach consists of three Specific Aims. Aim 1 addresses the design of our new instruments, in con- junction with the variable view angles provided by our optic, and endowing them with bipolar electrosurgery capability. Aim 2 focuses on the design of a novel touchscreen-based user interface that enables the surgeon to simultaneously control the endoscope and the instruments delivered through it. Aim 3 consists of ex vivo and in vivo animal studies to demonstrate the robot’s ability to reach everywhere in the uterus, to enable surgeons to perform the procedure who otherwise could not, and to resect FIGO type 0, 1, and 2 fibroids of various sizes from all relevant locations (the fundal, anterior, posterior, lateral-left, and lateral-right zones) of the uterus efficiently. The endpoint of this R01 is a device that has been fully validated in established clinical training scenarios and live animals, setting the stage for clinical translation after the successful completion of this R01.

Narrative: Public Health Relevance Four in every five women will have uterine fibroids in their lifetime, over 1.6 million will be diagnosed each year, and over half a million of those will undergo surgery for fibroids. Two-thirds of these women will have invasive surgery to remove their uterus, even though the best surgeons have shown that just over 50,000 of them per year could have minimally invasive uterine-sparing endoscopic interventions if they were fortunate enough to be treated by an elite surgeon. We propose to create a new robot that makes endoscopic fibroid removal easier to perform, so that many more surgeons can offer it to many more women every year.