Dislodgment Force – Stent Securement
Force required to initiate stent displacement from its initial crimped position and to completely dislodge the stent from the delivery system.
Shim plate method. The IDTE-1000 is used to measure the force required to dislodge the pre-mounted stent from the crimped position on the non-expanded balloon and to completely separate the stent from the non-expanded balloon. The sample is advanced into a specific sample retainer fixture, made of two plates forming a hole with a specific diameter. The IDTE roller system is used to grab the catheter with a constant grip force. The catheter is pushed or pulled through the stent retainer system until the minimum dislodgement force is recorded. Stent Behaviour is recorded with a video camera.
Pre-conditioning can be done by passing the system through a tortuous anatomy before the test.
-Stent Sample retainer fixture
Measure and record forces required to dislodge a balloon-expandable stent from its delivery system under clinically relevant conditions.
Forward Motion Dislodgement (Lesion-type test) : Advancing a stent delivery system across a tight lesion could result in stent dislodgement.
Reverse Motion Dislodgement (Guide-type test) : Withdrawing a stent (un-deployed) delivery system into a guiding catheter, arterial sheath, or hemostasis valve could result in stent dislodgement.
Worst case stent securement configuration is used for this test.
- Balloon expandable stent
- Any balloon mounted devices
Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
Standard Guide For Measuring Securement Of Balloon Expandable Vascular Stent Mounted On Delivery System
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