Medical Device

❤️ Cardiovascular Stent & TAVI Frames

Thin-strut lattice/expanding cage structure (struts 0.1-0.5mm), crimped delivery configuration, self-expanding or balloon-expandable

4 Components 1 Materials 3 Processes 4 Standards

What is Cardiovascular Stent & TAVI Frames?

❤️ Cardiovascular Stent & TAVI Frames represents a complete system of precision titanium components engineered for Medical Device applications. Thin-strut lattice/expanding cage structure (struts 0.1-0.5mm), crimped delivery configuration, self-expanding or balloon-expandable The system integrates 4 distinct component types manufactured through 3 specialized processes.

Key manufacturing processes for this system include CNC swiss turning for cardiovascular geometry, Cryogenic deburring for net-shape tolerance, Ultrasonic clean Class 10k for net-shape tolerance, Sterile packaging for net-shape tolerance, CNC swiss turning for interventional geometry, each selected and qualified to meet component-specific requirements.

Engineering & Design Principles

Material: Nitinol (Ni-Ti shape memory alloy) provides the unique superelasticity required for self-expanding stents and TAVI frames. The alloy undergoes martensitic transformation at body temperature.

Form: Nitinol begins as precision-ground tube (OD 1-8mm). Laser cutting of the stent pattern, followed by shape-setting heat treatment and electropolishing.

Standards & Material Specifications

Standards: ASTM F2063 Nitinol, superelastic condition, Af 25+-3C, 100% dimensional + corrosion testing, sterile packaged

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Engineering Solution Blueprint

Cardiovascular Stents, TAVI Frames & Neuro-Interventional Devices

Medical Device

1 Part Feature Analysis

Laser-cut tube (stent) with expandable lattice cells, self-expanding Nitinol TAVI frame with barbed anchoring and sealing skirt interface, neurovascular guidewire core with precision-ground tapered distal section

  • ⚠️ Fatigue fracture of stent struts under cyclic arterial loading (400M+ cycles/year)
  • ⚠️ Restenosis from excessive vascular injury during deployment
  • ⚠️ Stent thrombosis from incomplete endothelialization
  • ⚠️ MRI compatibility for post-operative imaging surveillance
  • ⚠️ Guidewire tip kinking during navigation of tortuous cerebral vasculature

2 Material Selection Rationale

Nitinol (Ni-Ti Shape Memory Alloy) — Superelastic, shape memory effect, high damping

Nitinol (Ni-Ti Shape Memory Alloy, ASTM F2063) is the standard for self-expanding stents and TAVI frames — superelastic plateau strain >8% for vessel conformability and crush recovery. Grade 23 ELI for balloon-expandable stent platforms requiring high radial strength with low strut thickness (65-80um). Nitinol guidewire core for neuro-interventional kink resistance.

3 Form Selection Rationale

Seamless Tube — for fluid systems, heat exchangers

Seamless Nitinol tube (OD 1.5-8mm) for laser-cut stent and TAVI frame manufacturing. Centerless-ground wire for guidewire cores. Tube wall thickness 0.15-0.5mm for stents.

4 Manufacturing Process & Services

Core Processes:

Vacuum arc melting (VAR) of Nitinol ingot (precise Ni:Ti ratio)Laser tube cutting of stent lattice patternShape setting heat treatment in argon atmosphereElectrochemical polishing of strut surfacesCrimping + loading onto delivery balloon/catheter

Toll Processing Services:

Scanning electron microscopy (SEM) of strut qualityCrimped profile measurementExpansion test (balloon or self-expanding)Fatigue testing (accelerated 10-year simulation)Sterilization validation

Process Pitfalls:

  • ⚠️ Nitinol transformation temperature (Af) must be tuned to +-2C for body-temperature superelasticity — off-spec Af causes incomplete stent expansion
  • ⚠️ Stent strut surface must be free of micro-cracks >5um — laser dross must be removed by electrochemical polishing without over-etching

5 Procurement Specifications

ASTM F2063 Nitinol / ASTM F136 Ti-6Al-4V ELI, 100% SEM of cut quality + expansion tested per lot, ethylene oxide sterilized

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Manufacturing Process Flow

1
Electropolishing

Titanium anodizing (AMS 2488) grows a controlled oxide layer through electrochemical conversion in an electrolyte bath. Type II produces interference

2
Laser micro-cutting of tube

Fiber laser cutting of titanium uses a focused 1 µm wavelength beam to melt and expel material through a coaxial assist gas jet. The narrow (0.1–0.3 m

3
Shape-setting heat treatment

Vacuum heat treatment of titanium in a controlled environment prevents oxygen/nitrogen pickup that causes alpha-case embrittlement. Programmable tempe

Components in This System

Component Material
Titanium Cardiovascular Stent Nitinol (ASTM F2063)
Titanium Embolization Coil Mandrel Nitinol (ASTM F2063)
Titanium Neuro Guidewire Nitinol (ASTM F2063)
Titanium TAVI Frame Nitinol (ASTM F2063)

Frequently Asked Questions

What titanium grades are used in Cardiovascular Stent & TAVI Frames systems?
Cardiovascular Stent & TAVI Frames components are manufactured from Nitinol (ASTM F2063). The specific grade is selected based on mechanical property requirements, corrosion resistance needs, and Medical Device industry regulations.
What manufacturing processes are used for Cardiovascular Stent & TAVI Frames?
The Cardiovascular Stent & TAVI Frames system components are produced using CNC swiss turning for cardiovascular geometry, Cryogenic deburring for net-shape tolerance, Ultrasonic clean Class 10k for net-shape tolerance, Sterile packaging for net-shape tolerance, CNC swiss turning for interventional geometry, Cryogenic deburring at 200W fiber laser. Each process is selected and qualified to meet the specific dimensional, metallurgical, and surface requirements of each component within the system.
What quality standards apply to Cardiovascular Stent & TAVI Frames components?
Cardiovascular Stent & TAVI Frames components are manufactured to ISO 5832-3 (selfexpanding cardiovascular applied), ASTM B348 (embolization coil applied), ISO 14971 (neurovascular microguidewire applied), ASTM F136 (transcatheter aortic applied) and other applicable specifications. Full material traceability, dimensional inspection reports, and certificates of conformance are provided with each shipment.
What industries use Cardiovascular Stent & TAVI Frames?
Cardiovascular Stent & TAVI Frames systems are deployed in Medical Device applications. Each industry has specific regulatory and performance requirements that drive material selection and process qualification.
Can you provide DFM feedback for Cardiovascular Stent & TAVI Frames designs?
Yes. Our engineering team provides free Design for Manufacturability (DFM) analysis for Cardiovascular Stent & TAVI Frames projects. Upload your CAD file (STEP, DXF, or DWG format) and our team will review your design within 24 hours.

Engineering Trends

  • ▸ Process: Laser micro-cutting of tube
  • ▸ Process: Shape-setting heat treatment
  • ▸ Process: Electropolishing

Related Manufacturing Capabilities

These specialized processes support Cardiovascular Stent & TAVI Frames component manufacturing.

Electropolishing Laser micro-cutting of tube Shape-setting heat treatment
About Boze Titanium Manufacturing Center

One Metal. One Focus. Infinite Precision.

Founded in 2011 in Baoji's Titanium Valley, BOZE Metal is dedicated exclusively to titanium — from raw material to precision engineering. AS9100D, ISO 13485 & ISO 9001 certified with 500+ clients across Aerospace, Medical & Motorsport industries, we deliver end-to-end precision titanium CNC machining with full material traceability from source to component.

Boze CNC Ti is the dedicated titanium manufacturing center of Baoji Boze Metal Products Co., Ltd.

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