1. Patent Ductus Arteriosus Occlusion Device Christina Mathieson Trung Nguyen Advisor: Dr. Tom Doyle BME 273 – Senior Design Project

2. Patent Ductus Arteriosus: General Information Connection of aorta and pulmonary artery Connection of aorta and pulmonary artery Functionally beneficial prior to birth Functionally beneficial prior to birth Maintained by low oxygen and high prostaglandins Maintained by low oxygen and high prostaglandins Usually closes within 10- 18 hours of birth Usually closes within 10- 18 hours of birth Abnormal if patent after 3 months Abnormal if patent after 3 months 1 in 2500 1 in 2500 Female:male 2:1 Female:male 2:1

3. Patent Ductus Arteriosus: Causes All factors unknown All factors unknown Prematurity of infant Prematurity of infant Rubella infection Rubella infection Random Random

4. Patent Ductus Arteriosus: Effects Increased volume load on left atrium and ventricle Increased volume load on left atrium and ventricle Distention and dilation Distention and dilation Delay in postnatal pulmonary vascular changes Delay in postnatal pulmonary vascular changes Growth retardation, breathlessness, poor feeding Growth retardation, breathlessness, poor feeding Congestive heart failure Congestive heart failure Bacterial endocarditis, aneurysm of ductus Bacterial endocarditis, aneurysm of ductus

5. Patent Ductus Arteriosus: Shapes Type A: Cone Type D: Aneurismal Type B: WindowType C: Tube Type D: Irregular Cone

6. Current Treatments: Surgery Left posterolateral thoracotomy Left posterolateral thoracotomy Ligation or dissection Ligation or dissection Chest tube 24hrs Chest tube 24hrs Hospital 6-7 days Hospital 6-7 days 6-8 month recovery 6-8 month recovery

7. Current Treatments: Coils Most common method Most common method Use multiple coils Use multiple coils Materials: Materials: Surgical grade stainless steel Surgical grade stainless steel Dacron fibers Dacron fibers Problem: Problem: Cannot occlude smaller PDAs Cannot occlude smaller PDAs Easily dislodge when too many coils Easily dislodge when too many coils

8. Current Treatments: Rashkind Double Umbrella Double Umbrella Polyurethane fabric on stainless steel frame Polyurethane fabric on stainless steel frame Wire frame limits sizes Wire frame limits sizes Must pre-order based on approx. size of PDA Must pre-order based on approx. size of PDA

9. Our Goals PDA occlusion device PDA occlusion device Delivered via 6 – 7F catheter Delivered via 6 – 7F catheter Effective for all ages Effective for all ages Conforms to various shapes of PDA Conforms to various shapes of PDA Able to retract and reposition Able to retract and reposition Biocompatible material (foam) Biocompatible material (foam) Low cost Low cost

10. Project Timeline DecJanFebMarApr Research****** Advisor Meeting ***** Material Decision ** ** Design****** Prototype****** Testing*** Currently, have basic design idea. Goal for this month: develop testing prototype, determine material, create delivery system

11. Work Completed Research Research PDA background: current treatments, material ideas, catheter sizes PDA background: current treatments, material ideas, catheter sizes Device shapes: Rashkind, coils, etc. Device shapes: Rashkind, coils, etc. Determined Shape: Mushroom Determined Shape: Mushroom Ideas: Ideas: Delivery system Delivery system Materials Materials

12. Mushroom Shape Flat top in Aorta Flat top in Aorta Conical / Tubular base in PDA Conical / Tubular base in PDA Top prevents dislodging Top prevents dislodging Base provides surface for coagulation Base provides surface for coagulation

13. Delivery System 6-7 F catheter 6-7 F catheter Similar to Rashkind implantation procedure Similar to Rashkind implantation procedure Enter PDA via Pulmonary Artery Enter PDA via Pulmonary Artery

14. Future Work Modify mushroom shape to prevent puckering Modify mushroom shape to prevent puckering Improve delivery system idea Improve delivery system idea Finalize material selection Finalize material selection Build prototype Build prototype Look into methods of testing device Look into methods of testing device