Official Achievement Announcement

We officially launch CustomFlex Pro, the world's first fully customized slotted semi‑rigid shaft platform, marking a paradigm shift from standardized products to personalized solutions. Based on patient CT/MRI data and surgical planning software, the platform generates personalized shaft designs for anatomically complex cases and delivers finished products within 72 hours via an intelligent laser cutting system. Currently offering over 400 customization options across four dimensions: dimensions, stiffness gradient, slot patterns, and surface functions, it has been successfully applied in complex neurointerventional, cardiovascular interventional and orthopaedic surgeries, raising anatomical matching accuracy between instruments and patients to 98.5%.

R&D Background & Pain Points

One‑size‑fits‑all standard shafts fail to meet diverse clinical demands. Neurointervention requires ultra‑small diameters (0.5–0.8 mm) and high flexibility to navigate tortuous intracranial blood vessels. Cardiovascular intervention needs medium diameters (1–2 mm) and balanced push‑and‑track performance for coronary lesions. Orthopaedic surgeries demand larger diameters (2–4 mm) and high torque transmission to drive screws or rivets. Robotic surgery calls for customized stiffness distribution and interface design to be compatible with robotic arms.

Surveys show that 91% of interventional physicians report limited choices of existing shafts, and 67% have compromised intraoperative operations due to ill‑fitting instruments. For complex cases (e.g., vessel tortuosity >180°, calcified lesions, anatomical variations), compatibility issues with standard instruments are more prominent, extending average surgical time by 40% and increasing complication risks by 2.8‑fold.

Core Technological Innovations

• Intelligent Medical Image Analysis & Path PlanningA deep‑learning algorithm is developed to automatically extract target anatomical pathways from CT angiography or MRI data, identifying key features including minimum bending radius, torsion angle, branch positions and lumen diameter. Using finite‑element analysis, the algorithm calculates optimal instrument parameters and outputs 28 design specifications such as shaft length, diameter, stiffness distribution and slot patterns. The system processes one patient's data in only 8 minutes with an accuracy of 0.2 mm.
• Multi‑Objective Optimization Design EngineA parametric model with 142 design variables is established, and the NSGA‑II multi‑objective genetic algorithm is adopted to find Pareto‑optimal solutions. Optimization objectives include crossability (minimum bending radius), push performance (axial stiffness), trackability (bending flexibility), torque transmission (torsional stiffness) and fatigue life. The algorithm generates 3–5 optimized design options for physician selection within 15 minutes. Optimization results are presented via 3D visualization, including stress distribution nephograms and fatigue life prediction.
• Flexible Manufacturing & Rapid‑Response SystemIntegrating intelligent laser cutting, robotic polishing and automatic inspection, the system enables rapid small‑batch production. The entire workflow from receiving design files to finished product delivery is completed within 72 hours. The minimum production batch is reduced to one unit, with unit cost only 30% higher than mass production. The system supports medical‑grade stainless steel, nickel‑titanium alloy and composite materials, with diameters ranging from 0.5 to 10 mm and lengths from 30 to 300 cm.

Working Mechanism

The core of customized solutions lies in anatomical adaptability. In terms of dimensions, instrument outer diameter is precisely calculated according to patient vessel size to avoid the dilemma of "too large to pass or too small to stabilize". Mechanically, stiffness gradients are designed based on pathway curvature, providing sufficient pushing force (axial stiffness >2 N/mm) for straight segments and appropriate flexibility (bending stiffness <0.5 N·mm²) for curved segments. Kinematically, optimal slot patterns are determined by target site locations to ensure instrument access to all lesion targets. Ergonomically, handle design and control modes are customized to match surgeons' operating habits.

For neurointerventional cases, microcatheters with ultra‑flexible tips and graded stiffness can be designed to improve navigation success through tortuous vessels. For orthopaedic spinal surgeries, drive shafts with high torque transmission ensure precise screw implantation. For robotic surgery, shafts with customized interfaces and stiffness distribution optimize force‑transmission efficiency.

Performance Validation

In clinical studies involving 186 complex cases, customized shafts demonstrate remarkable advantages. For intracranial aneurysm embolization (vessel tortuosity >180°), navigation success of customized instruments rises from 74% to 97%. For chronic total occlusion coronary intervention, average crossing time is shortened by 28 minutes (a 35% reduction). For percutaneous vertebroplasty, bone cement injection precision is improved by 42%. Post‑operative follow‑up shows a 76% reduction in complications caused by instrument mismatch (e.g., vessel dissection, perforation, instrument kinking).

Physician satisfaction surveys indicate that 97% of surgeons report improved surgical confidence and efficiency with customized instruments, with the highest scores for "manipulation precision" and "anatomical compliance". Health‑economic analysis reveals that although customized instruments cost 2.2‑fold more per unit, total single‑case surgical expenses are reduced by 28% through shorter operation time (25% reduction), fewer complications (70% reduction) and lower conversion‑to‑open‑surgery rates (from 12% to 3%).

R&D Strategy & Philosophy

We firmly believe that the most suitable instrument is the best instrument, and adopt the POP design philosophy (Personalization‑Optimization‑Precision). For personalization, we build the world's largest endoluminal instrument database containing performance data and clinical outcomes from 18 000 surgeries, establishing an "anatomical feature‑instrument parameter‑surgical outcome" mapping model via machine learning. For optimization, multi‑objective genetic algorithms are applied to seek optimal balance under constraints of crossability, manipulability and durability. For precision, designs are optimized via computational fluid dynamics and finite‑element analysis based on patient‑specific anatomical data.

We construct a digital closed loop of "design‑simulation‑manufacturing‑verification", achieving 0.15 mm precision in virtual surgical simulation and reducing physical prototype production by 90%. Meanwhile, we launch an open design platform where physicians can directly participate in design via cloud interfaces by selecting preset templates or customizing parameters, realizing genuine physician‑engineer collaborative innovation.

Future Outlook

Personalized medicine will drive slotted shafts toward four development directions: first, 4D‑printed smart instruments that undergo preset deformation under body temperature to adapt to intraoperative anatomical changes; second, bio‑integrative designs with surface‑modified specific extracellular matrix proteins to promote tissue healing; third, real‑time adaptive instruments based on electroactive polymers whose stiffness can be adjusted by surgeons via voltage intraoperatively; fourth, fully biodegradable instruments for paediatric patients that safely degrade within 6–12 months after treatment completion.

Our under‑development adaptive shafts will enter clinical trials in 2027. Equipped with shape‑memory alloys and sensors, they automatically adjust bending angles according to tissue impedance. In the long run, AI‑powered autonomous navigation instruments will become reality, automatically navigating inside the body based on pre‑operative planning and requiring physician confirmation only at key decision points. This will greatly reduce surgical difficulty and learning curves, enabling more patients to benefit from minimally invasive treatment.