Description

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It is a high-purity silicone tubing specifically designed for invasive or implantable medical procedures, meeting the highest standards of biocompatibility and functionality. Its core value lies in its biocompatibility, precise controllability, and long-term stability, making it a "lifeline" for critical surgeries such as coronary artery bypass grafting and reconstructive surgery.

Advantages

Highly biocompatible

No leachables, no allergenic components, and no immune response when in prolonged contact with human tissue, ensuring safe postoperative recovery for patients.

Ultra-soft tube wall design

With a Shore hardness as low as 20-30A, the tube is soft and conforms to organ tissue, reducing pressure and discomfort and improving postoperative comfort for patients.

Precise Specification Matching

Offers a range of tube diameters from 0.5mm to 12mm, as well as customized products with different bending angles, to meet the precise requirements of various surgical procedures.

High Strength and Fatigue Resistance

Withstands 1,000 bending tests without damage, maintaining structural integrity during surgical procedures and post-operative recovery to ensure functional stability.

Applications

Postoperative drainage

Used in abdominal surgeries such as hepatobiliary and gastrointestinal procedures to drain postoperative fluid and blood accumulation, effectively reducing infection risks; in orthopedic joint replacement surgeries to assist in draining joint cavity exudates and promoting wound healing.

Organ support and reconstruction

In otolaryngological surgeries, it serves as a nasal cavity and ear canal support tube to maintain postoperative structural stability; in urological surgeries, it is used for ureter and urethra support and reconstruction to aid in restoring organ function.

Minimally Invasive Surgical Channel

In thoracoscopic and laparoscopic surgeries, it functions as a gas delivery and surgical instrument manipulation channel to ensure clear surgical visualization; in neurosurgical minimally invasive procedures, it assists in drug delivery or tissue sample extraction.

Differences Between Surgical Silicone Tubing and Ordinary Silicone Tubing

Characteristics	Surgical Silicone Tubing	Ordinary Medical Silicone Tubing
Biocompatibility	Implant-grade standard (ISO 10993-1)	Contact-grade standard (e.g., USP Class VI)
Surface Treatment	Ultra-smooth inner wall (prevents blood clot adhesion)	Conventional smoothness
Anticoagulant Coating	Partially contains heparin/hydrophilic coating (reduces the risk of blood clotting)	None
Mechanical Precision	Ultra-thin walls + high elasticity (to prevent displacement during vascular/nerve anastomosis)	Conventional thickness
Sterilization Grade	Resistant to gamma rays/ethylene oxide (deep sterilization)	Conventional disinfection
Certification Requirements	FDA Class III device/CE MDR certification	Class I or II device certification

Production Process

Double Raw Material Inspection

Medical-grade silicone is selected and undergoes infrared spectroscopy and mass spectrometry analysis to strictly control heavy metal and small molecule impurity content and ensure raw material purity.

Clean Room Production

Extrusion molding is completed in a Class 10,000 clean room, with a laminar flow purification system used throughout the process to prevent particle contamination.

Platinum Vulcanization Process

Utilizing platinum-catalyzed cross-linking to avoid peroxide residues, enhancing product purity and biocompatibility.

Dual Sterilization Assurance

Depending on product characteristics, sterilization is performed using ethylene oxide (residual level < 10 μg/g) or electron beam irradiation, ensuring a sterility assurance level (SAL) of 10⁻⁶.

100% inspection before shipment

Each batch of products undergoes biological toxicity testing, seal integrity testing, and dimensional accuracy inspection to ensure 100% compliance with medical device standards.

FAQ

Q: Does the surgical silicone tubing require re-sterilization before use?

A: No. The product has been sterilized via ethylene oxide or electron beam irradiation and packaged in sterile packaging. It can be used directly after opening.

Q: How do I choose the appropriate silicone tube diameter?

A: Selection depends on the surgical site and clinical requirements. For example, nasal tear duct surgery typically uses a 1.5–2 mm diameter, while abdominal drainage tubes commonly use an 8–12 mm diameter.

Q: How long can silicone tubing remain in the body?

A: Answer: The retention time varies depending on the type of surgery and product design. Generally, short-term drainage tubes can be retained for 7-14 days, while organ support silicone tubes can be retained for up to 3-6 months.

Q: Does silicone tubing affect post-operative imaging studies?

A: Standard silicone tubing is non-radiopaque in X-ray and CT scans and does not interfere with image interpretation; however, in MRI scans, some silicone tubing may cause artifacts. It is recommended to select MRI-compatible products and inform the radiologist in advance.

Q: How should blockages in silicone tubes be handled during use?

A: If the drainage tube is blocked, try gently flushing it with sterile saline solution. If the blockage is severe or cannot be cleared, the tube should be replaced promptly.

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Surgical Silicone Tubing

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Applications

Production Process

FAQ

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