MIYAZAKI ENTERPRISES LLC — Department of Health and Human Services SBIR Phase I: NICHD

Description

Miya Model Sling SimulatorAbstract OB GYN Residents must develop numerous skills including pelvic examschild birthopen surgerylaparoscopic surgeryand vaginal surgeryStudies demonstrate that OB GYN Residents lack training in vaginal surgical techniquesincluding Vaginal HysterectomyVHthe desired hysterectomy techniqueand placing midurethral slings for Urinary IncontinenceUIMeeting the need for physicians trained in proper placement of slings for is a public health concern as the rate of UI is expected to grow rapidly with the aging populationThe Miya Model is a complete female pelvic anatomy model created to simulate actual surgical experiences including lifelike skin and life sized organsrealistic cutting and puncturing tensionspalpable surgical landmarksa pressurized vascular system with bleeding for inadequate techniqueand an inflatable bladder that can leak water if damagedThe model is modular in that all of the parts are designed as cartridges that are easily replaceable when utilized in a simulated surgeryThe anatomical correctness of the model can be used to train a broad range of health professionals on general procedures like bimanual examspeculum and pap smearas well as advanced gynecologic vaginal surgeriesThere is no commercially available simulator that has the potential to train multiple vaginal surgical skillsincluding VH and midurethral slingsother than the Miya ModelThe Miya Model has already demonstrated Content and Construct Validity for VHThis Phase I SBIR has five Specific Aims that if achievedwill add validated midurethral sling training to the Miya ModelThe first Specific Aim is to design and produce disposable vaginal cartridges for midurethral sling placement that are economical to use and required for a Construct Validation studyOur second Specific Aim is to develop a scoring paradigm for midurethral sling placement that will show a high degree of inter rater reliability when evaluating trainees on the Miya Model or live patientsOur third Specific Aim will use the vaginal cartridges of Specific Aimand the scoring system of Specific Aimto demonstrate that the Miya Model has construct Validity and can distinguish between novice and expert sling surgeonsThe fourth Specific Aim is to evaluate the metrics and scoring paradigm developed in Specific Aimand used in the Construct Validation study of Specific Aimto determine if any modifications are necessary to ensure a high degree of inter rater reliabilityThe final specific aim will be to modify the production design of the vaginal cartridgesdeveloped in the first Specific Aimbased on data gathered on the Construct Validation studyIn Phase IIa multi center Concurrent Validation study will be completed to demonstrate that training for midurethral slings on the Miya Model is superior to traditional training and the tooling for mass production will be producedWhen completedthe Miya Model will be used by numerous medical residency programsnot only OB GYNas well as a diverse group of nursing and allied health training programsIt will also be used by hospitals for credentialing and medical device companies for product development and training Miya Model Advanced Gynecological Sling Training SimulatorNarrativeOB GYN Residents do not receive adequate training in vaginal surgery techniques including vaginal hysterectomyVHthe hysterectomy technique recommended by The American College of Obstetricians and GynecologistsACOGmesh procedures for prolapse and sling procedures to treat Urinary IncontinenceUIStudies show that with the aging population the demand for surgeons trained in treating prolapse and especially UI will grow rapidly with the aging populationThe proposed research and development program will extend the capabilities of the Miya Modelwhich has already demonstrated Construct Validity for VHto become the first and only validated simulator for training surgeons in placing midurethral slingsmeeting a crucial public health need and having a profound impact on womenandapos s healthcare