CTO Presentation
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Transcript of CTO Presentation
Disease Characteristics
Location : • SFA 50% • Tibial 23% • Popliteal 22% • Peroneal 5%
• Length 117.5mm • Age 16.0 Months • Mod/Severe Calcium 75.0%
Procedure Dominant technique
• Antegrade Sub-intimal Tracking and Re-entry (STAR)
Other Techniques • Retrograde • CART • Reverse Cart
Outcomes
• 70-80% Initial success with wired technique
• When the wired technique fails re-entry devices are used
• 80% Success with re-entry devices
• Most common reason for failure is In ability to re-entry the true lumen
• The failure rate increase as the size of the vessel decreases
Our device
• Improve the rate of re-entry
• Cost Effective
• Treating the Superficial Femoral Artery
Features: • Self Orientating Head • Rotating Collar • Low Level of Complexity • Cost Effective Design
Key Concepts
Catheters• Composition:
o Handle o Proximal shaft o Distal shaft o Distal tip - Consists of a spring coil
• Made from: o Silicon o Latex o Polyvinyl Chloride
o Size: - Medtronic: 0.889
microns diameter
Manufacturing ProcessCutting the tubing's, stretching and necking it using machines like: extrusion die stretcher
The shafts are welded together using tubing machines such as the TBW-500 QX
• Micro Injection Mould: o Easy to make small components o Stress free plasticization o Good for Mass production
• Electric discharge machining (EDM)-Material is removed from the work piece by a series of rapidly recurring current discharges between two electrodes o Easy to cut complex shapes that would
otherwise be difficult to produce with conventional cutting tools.
o Good surface finish can be obtained. • Laser Cutting- high-powered beam to cut material
based on computer-controlled parameters. o Processes cost less than machining or EDM
methods o Fast, better quality, repeatable processes
Manufacturing Methods
Equipment testing• Gas Pressure Leak Testers
o Model GPL-501 – uses nitrogen gas which is inert so leaves no residue
• Hydraulic Pressure Testers o Model PT-3070 - A variety of high-pressure tests can be performed requiring pressure cycles with a specific sequence, magnitude, and number of repetitions. The system records measurements of pressure, volume, flow rate, time and balloon diameter.
• Length Diameter Measurement System - The Length Diameter Measurement System eliminates errors associated with
manual contact measurements, as well as, variations due to operator skills.
http://www.interfaceusa.com/equipment/testing-equipment/
Test Aims
• Measure the forces required to enter the smooth muscle tissue
• Test our devices ability to remain in the vessel wall and in the correct orientation
• Test the our devices ability to remain in position while the guide wire is returned
Procedure
Testing will be conducted in Bruce Murphy’s lab: • First a prototype will need to be manufactured • The artery type needs the correct thickness • 0.35 mm Tapered Tip 0.25 mm
Limitations • Healthy tissue is being tested • In vitro model • Occlusion Length
Patent Search
Google patent search • “Chronic total occlusion re-entry device” • Returned 65,800 results ???
Patent Search Category search on Escpacenet • A (Human Necessity) • 61 (Medical OR Veterinary Science; Hygiene) • B (Diagnosis; Surgery; Identification) • 17/00 (Surgical instruments, devices or methods) • A61B2017/22095 • “Accessing a blood vessel true lumen from the sub-intimal
space” • Escpace 195 results • Google Patent 701 results
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