Minimally Invasive Vaginal Prolapse Repair
Department of Health and Human Services
Agency Tracking Number:
Solicitation Topic Code:
Small Business Information
KEY TECHNOLOGIES, INC.
40 EAST CROSS STREET, BALTIMORE, MD, 21230-
Socially and Economically Disadvantaged:
AbstractDESCRIPTION (provided by applicant): This project will develop new surgical tools and procedures to facilitate a minimally invasive repair for uterine or vaginal vault prolapsed, a disorder of the female pelvic floor. The current gold standard operation for this disorder is the sacral colpopexy, primarily performed via laparotomy in which a relatively large abdominal incision is made to access the area in a manner similar to that performed for a cesarean section or abdominal hysterectomy. This procedure hasa high success rate but entails the pain and morbidity associated with the large abdominal incision. A small but increasing number of surgeons are now performing sacral colpopexy via laparoscopy or robot-assisted laparoscopic surgery, including a novel technique that utilizes a single 2-3 cm umbilical incision. Although feasible, the current laparoscopic equipment has deficiencies that make this procedure difficult, limiting its practice to those with advanced laparoscopic skills who are willing to undergoa steep learning curve. Even when performed by experienced surgeons, sacral colpopexy performed laparoscopically or robotically requires longer operative times and increased operating room (OR) personnel when compared to open sacral colpopexy. This project will transform this gold standard procedure into one that is primarily performed via laparoscopy or robot-assisted laparoscopic surgery, including the single-incision / single-port approach. This will reduce hospital stays, potentially decrease blood loss and operative morbidity, reduce post- operative pain, and support an earlier return to normal activities. It will also allow the procedure to be rendered more efficiently, with a shorter learning curve and a reduction in OR personnel and costs. Beyond the sacral colpopexy, the equipment and tooling being proposed will provide a platform for a range of female pelvic surgery procedures, most notably, the laparoscopic or laparoscopically assisted hysterectomy. This project will be completed in several sequential stages. First, the preliminary surgical tools and procedures will be finalized (based on designs and feasibility testing completed in Phase I). Next, the tools and procedures will be tested in a cadaver model, which is intended to prove the safety andperformance of the tools and procedures. The project will conclude with human subject testing that will demonstrate safety and performance in human subjects, which will include post-operative follow up. An outside panel of medical peers will be formed tofollow the project, to provide feedback on the safety and efficiency of the approach and tooling and to suggest improvements. PUBLIC HEALTH RELEVANCE: Each year, approximately 200,000 women undergo inpatient procedures related to pelvic organ prolapsed in the United States and it is expected that this number will rise with the aging population. A current surgical repair procedure (known as sacral colpopexy ) is typically performed via laparotomy in which a relatively large abdominal incision is madeto access the pelvic area (similar to that performed for a cesarean section or abdominal hysterectomy). This project will develop an improved laparoscopic approach that will use minimally invasive techniques to perform this procedure using very small patient incisions. This is expected to decrease operative morbidity, reduce patient pain and recovery time, and shorten hospital stays and costs.
* information listed above is at the time of submission.