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Redesign of a Distal Protection Filter for Carotid Artery Stenting University of Pittsburgh Senior Design – BioE 1160/1161 Sandeep Devabhakthuni Chenara.

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Presentation on theme: "Redesign of a Distal Protection Filter for Carotid Artery Stenting University of Pittsburgh Senior Design – BioE 1160/1161 Sandeep Devabhakthuni Chenara."— Presentation transcript:

1 Redesign of a Distal Protection Filter for Carotid Artery Stenting University of Pittsburgh Senior Design – BioE 1160/1161 Sandeep Devabhakthuni Chenara Johnson Daphne Kontos Perry Tiberio April 18, 2005 Mentor: Ender Finol, PhD

2 Arterial Stenosis Narrowing of carotid arterial walls due to plaque build-up Considered 3 rd leading cause of death - Stroke New, less invasive treatment: Carotid Artery Angioplasty and Stenting Problem: Possible embolization to the brain resulting in a stroke. Solution: Embolic Protection Devices

3 Background

4 Filter Properties Neuroprotection (distal protection) filter Polyurethane material for the basket Nitinol tubing Nitinol Stainless steel µm pore size

5 Problem Statement Predicate devices include the FilterWire EX, AccuNet and Angioguard These filters are 80-90% efficient The goal of our design is to maximize emboli capture efficiency AccuNet FilterWire EX Angioguard

6 Design Requirements 99% capture efficiency Lay flush with vessel lumen Biocompatible Durable Collapsible For insertion and retrieval

7 Economic Considerations and FDA Regulation Market Size: $752M worldwide Distribution Medical Supply Companies FDA Classification Class II – Cardiovascular Diagnostic Device

8 Quality System Considerations Manufacturability Simple Design Materials already used for other medical purposes Human Factors Easy to use for trained interventional cardiologists To be determined through survey Biocompatible

9 Incorporate the best features/materials from all current designs into our filter Implement a novel feature to improve design Initial Design Considerations

10 Ring Three struts Polyurethane basket 70-80µm pore size Skirt Proposed Solution

11 Ring One Strut Extra Struts don’t assist in securing filter Stainless steel wire Nylon filter basket Nylon due to material restrictions Polyimide tubing to enforce nitinol ring Pore size of 70-80µm Captures smaller particles Nylon skirt Final Design

12 Prototype Fabrication Shape nitinol into ring and reinforce with polyimide tubing Attach stainless steel wire guidewire

13 Prototype Fabrication Dimensions of filter Basket Outline filter on nylon sheet Cut out pattern and put together with polycyanoacrylate

14 Final Prototype

15 Intended Method of Use Collapse filter by pulling strut Insert percutaneously Deploy filter by releasing strut Pre-shaped to align 20° to vessel wall After procedure, retrieve into retrieval sheath

16 Experimental Methods Used to Test Device Performance Glycerin-water solution (9:16) in flow loop Insert filter into loop Set peristaltic flow to 150 mL/min Inject embolic beads Run for 5 minutes Weigh beads passed and collected by filter

17 Schematic of Flow Loop Insertion Point of Filter (one- way valve) Reservoir Peristaltic Flow Pump Length = 20 cm Point of Filter Deployment Glycerin/Water solution (9:16) Inline filter Insertion Point of particles

18 Data Analysis Embolic capture efficiency determined by: ezANOVA Between- and In-group comparison Student’s Paired t-test

19 Experimental Results Trial 1: 98% capture efficiency!

20 Experimental Results (cont.)

21 Filter Comparison Chart AngioGuardAccuNetFilterWireOur Filter Capture Efficiency * *The modified capture efficiency data is presented here

22 Discussion Nitinol ring cracked during trial 2 Bottom of filter tore during trial 6 Filters are designed for one time use only Poor results due to: Placement of filter Retrieval mechanism

23 Competitive Analysis for Prototype I Strengths Reduced pore size 74 microns compared to 80 – 120 micron range of filters currently on the market Skirt Assists in maximizing capture efficiency Deeper basket Prevent loss during retrieval of filter

24 Competitive Analysis for Prototype I Weaknesses Non-collapsible filter Non functional delivery or retrieval method Not a 1:1 scale

25 Future Redesign flow loop to include: Pressure Transducers Latex Tubing Redesign a second prototype to include: Develop a deployment/retrieval mechanism Use polyurethane as the filter basket material Use nitinol tubing

26 Acknowledgements Dr. Ender Finol Sanna Gaspard Mark Gartner Special thanks to Drs. Hal Wrigley and Linda Baker whose generous gift made this project work possible University of Pittsburgh, Department of Bioengineering Carnegie Mellon University


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