1. Thomas Hoy Department of Biomedical Engineering BME 273 Senior Design January 30, 2004

2. Project Definition What is a Ostium Secundum Atrial Septal Defect? What is a Ostium Secundum Atrial Septal Defect? congenital heart disease congenital heart disease causes left to right shunting across interatrial septum causes left to right shunting across interatrial septum Why should we care? Why should we care? Isolated secundum atrial septal defects of significance occur in approximately 70,000- 100,000 individuals today.Isolated secundum atrial septal defects of significance occur in approximately 70,000- 100,000 individuals today. Isolated ASDs can cause congestive heart failure or Eisenmengers syndromeIsolated ASDs can cause congestive heart failure or Eisenmengers syndrome

3. Goals To develop a less costly occlusion device for an ASD. To develop a less costly occlusion device for an ASD. To develop an occlusion device that is easily sized to the ASD. To develop an occlusion device that is easily sized to the ASD. To ensure easy use of this device in medicine. To ensure easy use of this device in medicine.

4. Further Goals To design a device that should: To design a device that should: Provide more accurate applicationProvide more accurate application Less strain on the applied interatrial wallLess strain on the applied interatrial wall Stimulate endotheliazation of the deviceStimulate endotheliazation of the device Be lower in cost and more simplistic in designBe lower in cost and more simplistic in design Improve the quality of life of the patientImprove the quality of life of the patient

5. Common Occlusion Devices Amplatzer – most widely used Amplatzer – most widely used HELEX Device HELEX Device Das Angel Wings Das Angel Wings ASDOS ASDOS STARFlex Occluder STARFlex Occluder Sideris "Buttoned Device" Sideris "Buttoned Device"

6. Amplatzer Occlusion Device Research Research Study of engineering aspects of the Amplatzer designStudy of engineering aspects of the Amplatzer design Study of how devices fit into catheters and how they work.Study of how devices fit into catheters and how they work. Brainstorming possible solutions to these problem Brainstorming possible solutions to these problem

7. Amplatzer Deployment Patient is sedated Patient is sedated Dynamic X-ray device used with dye to place the device Dynamic X-ray device used with dye to place the device Conformation through trans-esophageal echocardiogram Conformation through trans-esophageal echocardiogram

8. Amplatzer Detachment Locking mechanism screws into place Locking mechanism screws into place Device is unscrewed from catheter Device is unscrewed from catheter Amplatzer is able to be recaptured if a problem were to arise. Amplatzer is able to be recaptured if a problem were to arise.

9. Before and After

10. Future Work Scheduled another meeting with advisor to discuss progress Scheduled another meeting with advisor to discuss progress Continued brainstorming and documentation of possible designs and implementation devices Continued brainstorming and documentation of possible designs and implementation devices Study engineering possibilities of designs and modeling for catheter deployment Study engineering possibilities of designs and modeling for catheter deployment Model Model

11. Works Cited Moodie DS, Sterba, R. Long-term outcomes excellent for atrial septal defect repair in adults. Cleveland Journal of Medicine 2000; 67(8):591-597. Moodie DS, Sterba, R. Long-term outcomes excellent for atrial septal defect repair in adults. Cleveland Journal of Medicine 2000; 67(8):591-597. Hughes ML, Maskell G, Goh TH, Wilkinson JL. Prospective comparison of costs and short term health outcomes of surgical versus device closure of atrial septal defect in children. Heart 2002; 88:67-70. Hughes ML, Maskell G, Goh TH, Wilkinson JL. Prospective comparison of costs and short term health outcomes of surgical versus device closure of atrial septal defect in children. Heart 2002; 88:67-70. Thomson JDR, Aburawi EH, Watterson KG, Van Doorn C, Gibbs JL. Surgical and transcatheter (Amplatzer) closure of atrial septal defects: A prospective comparison of results and cost. Heart 2002; 87:466-469. Thomson JDR, Aburawi EH, Watterson KG, Van Doorn C, Gibbs JL. Surgical and transcatheter (Amplatzer) closure of atrial septal defects: A prospective comparison of results and cost. Heart 2002; 87:466-469. AGA Medical Corporation, http://www.amplatzer.com/products/aso_imp_demo.html AGA Medical Corporation, http://www.amplatzer.com/products/aso_imp_demo.html