1. Umbilical Cord Model for Umbilical Vein Catheterization Training Ann Sagstetter, Kelvin Ng, Megan Britson, Fan Wu Client: Dr. Julie Kessel, Department of PediatricsAdvisor: Professor Brenda Ogle, Department of Biomedical Engineering BACKGROUNDMotivation Many infants suffer trauma during delivery and often require immediate cathe- terization through the umbilical vein for resuscitation. Such a procedure is diff- icult and stressful, demanding training for clinicians in the delivery room. The American Academy of Pediatrics Neonatal Resuscitation Program (NRP) con- ducts such training several times a year. However, current training models are inadequate at simulating the procedure, and a more realistic model is needed. Prototype Characteristics Cuff mechanism provides adequate stability and accommodates variable cord sizes Silicone rubber cast simulates color and texture of infant abdomen Usage is compatible with existing NRP training and safety protocol Construction can be easily translated into industrial processes, specifically injection molding Estimated cost per unit = $12.61 Estimated annual demand = 70,000 ABSTRACT The goal of this project is to develop a realistic training model that can be used for umbilical vein catheterization training and incorporates real human umbilical cords. Two aspects are of primary concern: the stability of the umbilical cord, and the external texture of the infant abdomen. These were addressed by the cuff mechanism and silicone rubber cast that were developed over the past year. To fulfill the goal of utilizing the model in real training, various tests have been conducted to ascertain its advantages over existing models, and a manufacturing package was prepared for future negotiations with commercial manufacturers. Anatomy & Umbilical Vein Catheterization The umbilical cord consists of two arteries and one vein. During resuscitation, a 3.5-F or 5-F catheter is inserted into the umbi- lical vein (Figure 1) up to a depth of 5 cm beyond the umbilicus. The umbilical route provides painless and direct access to the infant’s circulatory system. Clinicians often use this procedure to perform drug deliv- ery, blood transfusion, hemodynamic mo- nitoring, and so on. PROBLEM STATEMENT To construct a model optimized in the following ways for use in the umbilical vein catheterization training program: firmly stabilize a fresh umbilical cord accurately mimic the external texture of an infant abdomen manufacturable and economically accessible for use in the NRP CURRENT PRODUCTS Two models exist in the current market to address NRP’s training protocol. Baby Umbi by Laerdal (Figure 2) does not sufficiently mimic the umbilical cord, while the NRP Baby Bottle Model (Figure 3) does not sufficiently mimic the infant abdomen. MANUFACTURING PACKAGE 1.Technical drawings with labeled dimensions, generated using SolidWorks 2.A user manual detailing the entire construction procedure (meant for the manufacturer) and the usage instructions (meant for the end user), ac- companied with a video that depicts the standard operating procedure 3.Test results to prove the model’s advantages over existing models 4.An estimated market demand based on the number of NRP sessions held annually (data obtained from the American Academy of Pediatrics) 5.An estimated capital per unit based on the raw materials (excludes ind- ustrial equipment and labor, energy expenditure, intellectual property as- sociated with original equipment manufacturers, materials research and opportunity cost) FUTURE WORK Optimize construction and usage procedures to improve aesthetics and user convenience Contact several manufacturers of interest, identify areas of ambiguity and assess compatibility with existing industrial processes Seek clearance from the American Academy of Pediatrics for use in NRP Further market research to obtain better estimates for target production quantity and cost REFERENCES John Kattwinkel. “Textbook of Neonatal Resuscitation”. American Academy of Pediatrics, 5th edition, 2006. “Insertion of Umbilical Vessel Catheters”. University of Iowa Health Care, 2006. [Online] www.uihealthcare.com/depts/med/pediatrics/iowaneonatology handbook/procedures/insertionumbilicalvessel.htmlwww.uihealthcare.com/depts/med/pediatrics/iowaneonatology handbook/procedures/insertionumbilicalvessel.html “Baby Umbi”. Laerdal. [Online] www.laerdal.com.auwww.laerdal.com.au John Walker. “Design / Manufacturing Process”. Fourmilab Switzerland, 2008. [Online] www.fourmilab.ch/autofile/www/section2_83_13.htmlwww.fourmilab.ch/autofile/www/section2_83_13.htmlACKNOWLEDGEMENTS We thank Professor Brenda Ogle and Dr. Julie Kessel for their guidance, Sharon Blohowiak for her assistance with laboratory procedures, Professor Tim Osswald for his expert advice on polymer selection and manufacturing, and Meriter residents for participating in the field surveys. We also appreciate contributions from Angwei Law, Timothy Balgemann, and Padraic Casserly in the last semester. EVOLUTION OF DESIGN Figure 1: Figure 1: Insertion of a cath- eter into the umbilical vein Figure 2: Figure 2: Baby Umbi by Laerdal Figure 3: Figure 3: NRP Baby Bottle Model Figure 9: Figure 9: Final Prototype Texture Mimicry Cord Stability Figure 4: Figure 4: Cuff model (left) and gel model (right) Figure 8: Figure 8: Rubber cast model (left) and artificial skin model (right), both conceptualized in this semester Figure 6: Figure 6: Foam model devel- oped last semester Figure 5: Figure 5: Mechanical and statistical test results CHOSENCHOSEN CHOSENCHOSEN ManufacturingConcerns Figure 10: Figure 10: Survey results gathered from clini- cians at Meriter Hospital Figure 7: Figure 7: Drawing of target de- sign (dimensions are in inches)