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Patent Ductus Arteriosus Occlusion Device

This project aims to develop a PDA occlusion device that can be delivered via a 6-7F catheter, is effective for all ages, conforms to various PDA shapes, and is made of biocompatible foam material. The project timeline includes research, device shape modifications, material specifications, and development of a delivery system plan.

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Patent Ductus Arteriosus Occlusion Device

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  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 • Functionally beneficial prior to birth • Maintained by low oxygen and high prostaglandins • Usually closes within 10-18 hours of birth • Abnormal if patent after 3 months • 1 in 2500 • Female:male 2:1

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

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

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

  6. Patent Ductus Arteriosus:Sizes • Narrowest segment average: 3.2±1.0 mm • Range: 2 mm – 8 mm • Length is highly variable (mm – cm) • Size variable regardless of shape

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

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

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

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

  11. Project Timeline

  12. Work Completed • Research • PDA background: current treatments, material ideas, catheter sizes • Device shapes: Rashkind, coils, etc. • Modified mushroom shape • Material specifications • Delivery device prototype plan

  13. Modified Mushroom Shape • Flat top in aorta • Modified top to prevent shunts (thicker in middle) • Conical / Tubular base in PDA • Top prevents dislodging • Base provides surface for coagulation

  14. Material Specification • Biocompatible to circulatory system • Properties of blood (immune system, no deterioration, etc.) • Able to withstand pressure differences • Malleable • Easy to mold • Expandable, able to fit in 6F catheter • Inexpensive

  15. Delivery System Plan • 6F catheter • Similar to Rashkind implantation procedure • Enter PDA via Pulmonary Artery • Enlarged prototype: • Foam piece approx 3 cm long, 1 cm wide • Catheter represented by straws • PDA represented by glass tubing

  16. Future Work • Test prototype • Visit catheter lab • Meet with Dr. Doyle • Prepare for poster presentation

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