China Customized PEBAX Welding Tubing Medical Grade Double-lumen Catheter

PEBAX Double Lumen Welded Catheter

The catheter material is PEBAX7233 + PEBAX5533

The PEBAX Double Lumen Catheter can withstand tensile force of more than 45N.The partial welding length of PEBAX5533 is 5mm.

It was very challenging, but the customer was extremely satisfied after delivery.

  

I. Core Advantages of PEBAX Double-lumen Welded Tube

1. Materials-wise: Advantages of the PEBAX series in medical applications

Excellent biocompatibility: 

• Meets medical standards such as ISO 10993, is non-toxic and non-allergenic, can directly contact human tissues/fluids, is suitable for short-term or long-term implantable devices, and has no risk of dissolution.

Mechanical property gradient design:

• Body PEBAX7233 (high hardness, approximately Shore D 72): Provides excellent pushability, support, and kink resistance, facilitating precise catheter placement to target sites (such as vascular bifurcation and deep cavities).

• Welding material PEBAX5533 (low hardness, approximately Shore D 55): More flexible, with a gradual transition in hardness at the weld area, reducing stress concentration and preventing catheter breakage at bends (such as in tortuous vascular locations), improving passability and durability.

Fatigue resistance and elasticity: 

• It is not easily fatigued and fails after repeated bending and stretching, making it suitable for instruments that require multiple operations or dynamic internal environments (such as vascular pulsation and cavity peristalsis).

Chemical and disinfection stability: 

• Resistant to mainstream disinfection methods such as ethylene oxide and gamma irradiation, and resistant to corrosion from body fluids and drugs, ensuring stable performance throughout the entire life cycle of the device.

Processability: 

• Due to its thermoplastic elastomer properties, it can be extruded, heat-welded, and heat-set, facilitating the fabrication of complex structures such as dual-cavity/multi-cavity structures and gradually varying hardness, making it suitable for industrial production.

2. Structural Level: Functional Advantages of the Dual-Cavity Design

Dual-channel independent delivery: 

• It can simultaneously perform two functions (such as "guidewire/instrument delivery + drug/contrast agent infusion" and "drainage + irrigation"), avoiding functional conflicts of single-lumen catheters and improving surgical efficiency and operational safety (such as reducing the number of instrument exchanges and reducing the risk of vascular injury).

Space optimization and minimally invasiveness: 

• Integrating multiple channels within a limited outer diameter reduces the overall size of the device, making it suitable for minimally invasive interventional procedures (such as vascular intervention and endoscopic surgery) and reducing trauma to patients.

Media isolation and accuracy assurance: 

• The dual-chamber physical isolation avoids the mixing of different media (such as drugs and contrast agents), ensuring drug administration/imaging accuracy and preventing cross-contamination.

3. Process aspect: Structural advantages of homologous welding

High-strength seamless connection: 

• Both are PEBAX series materials, and the molecular chains diffuse fully during hot welding. The 5mm welding length provides sufficient bonding area, and the mechanical properties of the welded area are close to those of the base material, eliminating the risk of cracking and leakage and ensuring the integrity of the device structure.

Adhesive-free biosafety: 

• No additional adhesives are required, avoiding issues such as leachates and allergens associated with adhesives, and meeting medical-grade safety requirements.

Smooth transition and stress buffering: 

• The low-hardness PEBAX5533 welded section forms a "hard-soft" transition, buffering the stress during pushing/pulling, reducing the probability of catheter bending or twisting in the body, and improving the handling feel and patient comfort.

II. Typical Applications in Medical Devices

PEBAX dual-lumen welded tubing, with its advantages of adjustable mechanical properties, multiple channels, and biocompatibility, is widely used in minimally invasive interventional medical devices, with core applications including:

1. Vascular interventional devices

   Coronary/Peripheral Vascular Catheters: Such as guiding catheters, microcatheters, and angiography catheters. Dual-lumen catheters can simultaneously deliver guidewires and contrast agents, used in procedures such as PCI (percutaneous coronary intervention), peripheral vascular stenosis and dilation, and cerebral embolization. The PEBAX7233 provides pushing force, and its flexible welded section adapts to tortuous vessels, precisely reaching the lesion site.

   Electrophysiology Catheters: Used for radiofrequency ablation of arrhythmias. Dual-lumen catheters carry electrode leads and infuse saline (for cooling the myocardium during ablation). The elasticity of the PEBAX ensures stable catheter positioning within the heart, and the gradually decreasing stiffness of the welded section reduces mechanical stimulation to the myocardium.

2. Digestive/Respiratory Interventional Devices

       ERCP catheter: Endoscopic retrograde cholangiopancreatography/treatment catheter. Its dual-lumen design             allows for guidewire guidance and contrast agent/drug infusion. It is used for the diagnosis and treatment of           pancreatobiliary stones and tumors. PEBAX's chemical resistance adapts to the digestive tract environment,             and its flexibility reduces damage to the bile duct.

       Bronchoscopic interventional catheter: Used for interventional treatment of lung tumors and airway stenosis.           Its dual-lumen design allows for the delivery of chemotherapy drugs and aspiration of secretions. PEBAX's               flexibility reduces airway mucosal irritation.

    3. Minimally invasive instruments for urology and gynecology     

       Ureteral catheters/stents: Dual-lumen design for urine drainage and drug infusion; PEBAX biocompatibility               adaptable to long-term placement (e.g., ureteral stents); welded segments fatigue-resistant to resist ureteral           peristalsis, preventing breakage and displacement.

       Hysteroscopic/Laparoscopic catheters: Used in minimally invasive gynecological surgeries, dual-lumen for               delivering surgical instruments and irrigation fluids; PEBAX manufacturability adaptable to small cavity sizes,           improving surgical field of vision and operational precision.

    4. Other medical scenarios

        Infusion/Drug Administration Catheters: Such as port-a-catheters, allowing simultaneous infusion of different          drugs via dual lumens. PEBAX's chemical resistance ensures drug stability, while its biocompatibility reduces            the risk of phlebitis.

        Drainage Catheters: Chest/abdominal drainage tubes, with dual lumens enabling "drainage of effusion +                  flushing/drug administration." PEBAX's flexibility adapts to changes in body position, reducing the risk of                tube  kinking and blockage.