A biodegradable high-purity magnesium closing clip for general surgery.

Area of Science:

• Biomaterials Science
• Surgical Innovation
• Medical Devices

Background:

• Current surgical closing clips (titanium, plastic, polymer) have limitations including permanent foreign body retention, tissue lesions, weak mechanical properties, and potential irritant degradation products.
• These limitations necessitate the development of advanced closing devices that are both effective and biocompatible.

Purpose of the Study:

• To develop and evaluate a novel, multifunctional, and biodegradable high-purity magnesium (HP-Mg) closing clip for laparoscopic surgery.
• To address the shortcomings of existing clinical closing clips by offering enhanced performance and improved safety profiles.

Main Methods:

• Design and fabrication of HP-Mg closing clips.
• In vivo evaluation in mouse, rat, and minipig models to assess degradation, biocompatibility, and tissue response.
• Analysis of Mg2+ and H2 release effects on collagen synthesis, wound healing, and tumor cell apoptosis.

Main Results:

• HP-Mg clips demonstrated enhanced clamping capabilities, preventing hemorrhage and leakage, with complete in vivo degradation within approximately 360 days.
• Released Mg2+ promoted collagen synthesis, accelerating wound healing, and Mg2+/H2 induced tumor cell apoptosis.
• Degradation products were safely absorbed and metabolized, showing no significant adverse effects on major organs, tissue pH, or systemic inflammation.

Conclusions:

• Biodegradable HP-Mg closing clips represent a promising alternative to conventional clips in laparoscopic surgery, offering effective closure without permanent foreign body retention.
• The clips exhibit unique biofunctions, including accelerated wound healing and potential anti-tumor effects, supported by successful NMPA approval as a Class III medical device.