1. The depths of valve replacement Research Analysis Damian Carr Product Design & Technology 0878057

2. Topics Covered Introduction Valve replacement industry Access sites CAT lab Medtronic’s fore take Subclavian access in other fields Subclavian trials via Corevalve Transapical and transfemoral Direct aortic Design Stages for Catheters New Take on FYP Subclavian/Trans aortic handle needs Design Plan Summery

3. Introduction » Initial FYP idea: To create a Catheter that delivers a Medtronic Engager valve into an Aortic valve via a subclavian access » Field: Medical Industry » Funding: Medtronic » Project style: Mixed (blue sky/Incremental)

4. Valve replacement industry Due to calcified aortic valves Non invasive Typical in patients 65+ Survival rate 85%+ 2 forms of valve –Mechanical valves –Tissue valves Via Engineer Interviews/journals

5. Access Sites Via Medtronic Data

6. CAT Lab Via Cat lab visit June 2011

7. Medtronic’s fore take Currently produce 2 aortic valves - Corevalve and Engager Cover Transfemoral, Apical and Direct aortic 3 rd largest internal income Covers 18% of company sales Implanting since August 1992 In the top 3 companies for aortic replacement Via journal articles/interview/Online research

8. Subclavian access in other fields Angioplasty’s 113 patients Mean age – 63+/- 13 years 91% success 3 procedural complications 1 transient ischemic attack 1 fatal stroke 1 arterial thrombosis Conclusion – Safe and effective, good long term patency. Less arterial punctures, less bloodstream infection Central venous catheters (jugular vs subclavian Six trials(2010 cathaters) 6 times less arterial punctures Three trials(707 cathaters) Less than half bloodstream infection Via journal articles

9. Subclavian trials via Corevalve 6 implantations due to arterial blockage and apical risks Euro score 28.4% 100% success post surgery 89% success after 30 days 76% recovery in stage 1(first 2 days) Conclusion: reduced aortic gradient by 5mm immediately after valve replacement, non invasive, requires skin incision, less discomfort than transfemoral Via journal’s/ Online interview with Neil Moat(leading aortic surgeon)/Case report

10. Transapical and transfemoral High risk implantations between 2007-2009 203 patents, euro score 22%+/-14%, age 81+/-7years Transapical – 50 cases For patients who had no femoral access 30 day survival 91.7% Death due to 25% valve related, 25% cardiac, 50% non cardiac Transfemoral -153 cases 30 day survival 88.8% Death due to 31% valve related, 13% cardiac 56% non cardiac Via journals/ Online interview with Neil Moat(leading aortic surgeon)

11. Direct Aortic » Simular valve oriantation to subclavian » Same access direction » Simular shaft length needed » Covers 2 access points, thorocotomy(splits rib cage down the center) Sternotomy(splits 4 th and 5 th or 5 th and 6 th intercostal spaces in right rib cage » Only at animal trial phase, no implantations to date Via interviews with Designers/Engineers/Technicians s

12. Design Stages for Catheters Phase 0- Research, initial prototypes to prove principal Background research Mechanical capability Travel availability Tracking capability Phase 1- from conceptual design to design freeze » Capsule development » Shaft development » Mechanical finalisation » Flushing ability » Ergonomic incorporation » Aesthetical finishing Via interviews with Designers/Engineers/Technicians/Manifacturer

13. New Take on FYP » New FYP idea: To create a Catheter that delivers a Medtronic Engager valve into an Aortic valve via a subclavian access and creating a sister version of the handle that can be used for direct aortic access » Field: Medical Industry » Funding: Medtronic » Project style: Mixed (blue sky/Incremental)

14. Subclavian/Direct Aortic Handle Needs Colour -Must abide by the Medtronic colour chart

15. Subclavian/Direct Aortic Handle Needs Mechanics -Must Deploy 2 capsule half’s in 2 different directions using same directional movement -Must transfer force effectively and efficiently -Must be contained inside a handle or shell -Must not interfere with flushing -Materials must be medically acceptable -Must not fail during deployment

16. Subclavian/Direct Aortic Handle Needs Flushing -Must flush up the inner shaft -Must flush the capsule leaving no air bubbles -Must flush between the inner and the intermediate shafts -Must flush between the Intermediate and the outer shafts -Must flush the introducer device or what may replace its function

17. Subclavian/Direct Aortic Handle Needs Handle -Must be capable of at least 90% of surgeons being able to use it with one hand -Must be ergonomic and create no strain in the surgeon’s hand -Must not be off balanced to a degree where it troublesome to use -Must not be too short -Must have a capsule quick closure system incorporated for post deployment of valve

18. Subclavian/Direct Aortic Handle Needs Safety -Must not be able to deploy capsules in the wrong order -Must not be able to quick close capsule before the valve is deployed -Must have a safety stop before the opening point of no return on the valve -Must keep flushing fluid inside handle during procedure

19. Subclavian/Direct Aortic Handle Needs Capsule -Must be A-traumatic -Must be able deploy in a small area -Must avoid all valve snagging -Must be visible under fluro -Must contain a 23mm valve and/or a 26mm valve -Must have a working capsule attachment method -Must have correct travel distance -Must have an appropriate travel ratio

20. Subclavian/Direct Aortic Handle Needs Shaft length -Must keep the surgeon out of the fluro -Must be short enough to avoid a high percentage error -Shaft stack up must match accordingly, allowing the shafts to be flushed but not too much space in between Shafts -Must be flexible -Must not over flex -Must not kink -Manufacturing processes must be non toxic -Must be able to carry or pull under force -Must not elongate over 2% -Inner diameter and outer diameter to match with 5-10 thousand of an inch clearance

21. Design Plan Design Brief Problem Definition/Statement Research Report and Design Specification Project Planning and Control Document Final Design Report Component Configuration Sketches and Models Human Factors Drawings and Mock-up’s Conceptual Renderings Concept Refinement Renderings Design Intent and Control Documentation Rapid Prototypes of parts Final Product Prototype and Aesthetic Model Showcase Presentation 1 week 1 weeks 3 weeks 1 week 2 weeks 4 weeks 3 weeks 2 weeks 1 weeks 2 weeks

22. End of Presentation Thank you for your time. Any questions?