Team 1

Ashtin Wilson, Jacob Parmenter, Nichole Cronin, Nick Ellis

Sponsored by Drs. Anthony Shanks and Caroline Rouse

IU Health Department of Obstetrics & Gynecology

Reusable Model for Training of Invasive Prenatal Procedures

In parternship with our sponsors Anthony Shanks and Caroline Rouse, our team worked to improve the training process for invasive prenatal procedures. These procedures are done to perform genetic testing on amniotic fluid and umbilical cord blood and pose a high risk due to the close proximity of the sampling needle to the fetus. Our model is ultrasound compatible and mimics the tactile properties of the abdomen and womb to attempt to reduce the rate of complications associated with these procedures.

Background & Significance

Invasive prenatal procedures (IPPs) are defined as procedures performed on pregnant mothers to assess the wellbeing and condition of the growing fetus where a needle is inserted into the uterus to withdraw sample material. The three most common forms of these procedures, and those being considered in the scope of this project, are amniocentesis, percutaneous umbilical blood sampling (PUBS), and chorionic villus sampling (CVS). These procedures take samples of the amniotic fluid, umbilical blood, and the chorionic villi found on the surface of the placenta respectively. These samples are then used for genetic testing to confirm suspected genetic disorders, such as Down's syndrome, with up to 99% accuracy. All 3 procedures are performed under live ultrasound imaging, and as a result benefit from proper tactile training to build hand-eye coordination and experience in the procedures.

IPPs are relatively rare during the development of pregnancy, and occur in less than 7% of pregnancies in the U.S. However, this results in poor training practices for resident and fellow OB/GYNs. The risk associated with these procedures is also quite high, with miscarriage of the fetus occurring in up to 3% of procedures. Other adverse effects following these procedures are possible, including internal bleeding of the mother or fetus and infection.

High-fidelity training models for IPPs are mass-produced. One such example is the CAE Blue Phantom™ amniocentesis training model. This model accurately replicates both mechanical and acoustic properties of human tissue to give the model accurate resistance to needle insertion and appearance under ultrasound. However, this model retails for $7,700 and is only directly applicable to amniocentesis. This places it outside of the typical training budget for the department considering the rarity of the training. Low-fidelity models are a more common choice for OB/GYNs. These models often use single-use materials to mimic human tissue, including chicken breast, tofu, gelatin, and elastic sheets. However, while cheap, these models are unsanitary, messy, and not applicable for repeated use. Our goal with this project is to bridge the gap in technology between low- and high-fidelity models to create a trainer which is accurate and reusable at a much lower cost.




Point of Care

User Needs

In order to best accomplish the overall goal set by the project sponsors, we developed 6 distinct requirements the final prototype would need to fulfill.

  • Ultrasound Compatibility - The model in use shall have comparable appearance to a patient receiving the procedure under ultrasound

  • Psychomotor Skills Practice - The procedure for training with the model shall recreate the hand-eye skills required to perform the procedure

  • Tactile Realism - The materials used to model each tissue layer shall have comparable material properties to actual tissue

  • Anatomical & Size Realism - The dimensions of each model component shall mimic the size of the fetus and womb at 20 weeks of gestation. The

  • Reusability - To improve upon the current low-fidelity trainers, our model shall be reusable for multiple training sections

  • Cost - To compete with high-fidelity trainers, our goal for the final prototype cost is $500

Poster

Who We Are

Acknowledgments

We want to sincerely thank everyone who made this project possible...

  • Anthony Shanks, MD, FACOG & Caroline Rouse MD, FACOG: Project Sponsors

  • Sharon Miller, PhD & Lester Smith, PhD: Design Process Advisors

  • Mark Holland, PhD: Ultrasound Imaging Physicist

  • Brian Overshiner, BSRT(T) & Tim Nisi, BA(Econ): 3D Innovation, Modeling, and Prototyping Specialists

  • Dan Minner, PhD: Materials Science Specialist & IUPUI MakerSpace Coordinator

  • Sherry Clemens, BSBio & Travis Kening, BSBME: Resource Suppliers

  • Dong Xie, PhD & Steven Higbee, PhD: Biomedical Material Science Specialists