Chronic Total Occlusion Re-entry Device

Philip Byrne James Redmond Finnian Flood Myeda Kamal

Introduction

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

Scholtes V P et al. Circ Cardiovasc Interv. 2012;5:e6-e8

Scholtes V P et al. Circ Cardiovasc Interv. 2012;5:e6-e8

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

Our Device

Carried out Research

Keep if Simple

Constant Revision

Concept Development

Features: • Self Orientating Head • Rotating Collar • Low Level of Complexity • Cost Effective Design

Key Concepts

In Use

Positioning of Device

In Use

Manufacturing

Manufacturing

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 

Manufacturing process includes:Head

Collar

• 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/

Testing

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

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

Various Patent

Various Patent

Similar Patents

Boston Scientific 15 Jan 2013

First Claim • “first and second mechanically

actuatable wings”

Most Similar Patents Boston scientific 24 May 2012

“the flattened shape including first and second wings extending in opposite directions”

“actuation of the deflection wire causes the distal portion of the elongate shaft to deflect into a curved configuration”