SBIR-STTR Award

Although uterine manipulators have been used in many forms for a number of years, all of the existing manipulators have different limitations. With the increasing pressure for cost containment and the increasing popularity of laparoscopic gynecological procedures moving to the outpatient clinic and GYN office, a cost-effective uterine manipulator that can be easily used by he laparoscopist is very attractive. We will develop an inexpensive uterine manipulator that will allow the gynecologic laparoscopist to freely position the uterus. This would lead to a more cost effective laparoscopic surgery due to greater ease in uterine manipulation and assuring greater safety because of better visualization. A basic feature of this low-cost device is a pivot point positioned at the cervical opening. In addition, this manipulator will be easy to insert, simple to secure firmly in place, and readily set in a given position. The device will be disposable to prevent cross-contamination and eliminate the need for tedious cleaning. An important feature of the device will be the ability to perform uterine injections of dye using a soft (silicone) balloon which will engage and firmly hold the manipulator in place within the uterine cavity and seal the dye within the cavity.Awardee's statement of the potential commercial applications of the research:This new uterine manipulator could be used in all of the wide range of laparoscopies involving the female pelvic organs (uterus, tubes, ovaries) when a uterus is present. The number of procedures of this type is currently estimated to be greater than a total of 1.5 million procedures per year in the U.S. With an estimated sales price of $20 this translates into a U.S. sales volume of $30 million per year.

Adequate exposure is vital in pelvic surgery. During laparoscopic procedures, uterine manipulation is an integral part of obtaining exposure. Although uterine manipulators have been used in many forms for a number of years, all of the existing manipulators have different limitations. We propose to complete the development and perform a significant number of clinical trials with a uniquely designed uterine manipulator. This manipulator provides more cost effective laparoscopic surgery due to greater ease in uterine manipulation. This device assures greater safety by applying counter traction and by providing better visualization. A basic feature is a pivot point positioned at the cervical opening. This manipulator is easy to insert, simple to secure firmly in place, and is readily set to a given position. It provides a greater range of motion, eliminates the need for an assistant, obviates the use of stirrups to reduce hip flexion and nerve compression, and allows for manipulation without a toothed cervical tenaculum. The device is disposable to prevent cross-contamination and eliminates the need for tedious cleaning. An important feature is the ability to perform uterine injections of dye using a soft (silicone) balloon to engage and firmly hold the manipulator in place within the uterine cavity and seal the dye within the cavity. PROPOSED COMMERCIAL APPLICATION: This new uterine manipulator could be used in all of the wide range of laparoscopies involving the female pelvic organs (uterus, tubes, ovaries) when a uterus is present. The number of procedures of this type is currently estimated to be greater than a total of 1.5 million procedures per year in the US. With an estimated sales price of $20 this translates into an approximate US sales volume of $30 million per year.