Gastrointestinal anastomotic nail with degradable drug film layer and preparation method of gastrointestinal anastomotic nail

Abstract

The invention discloses a gastrointestinal anastomotic nail with a degradable drug film layer and a preparation method of the gastrointestinal anastomotic nail. The gastrointestinal anastomotic nail is composed of a degradable metal nail base and a drug-loading film layer. The degradable gastrointestinal anastomotic nail is a U-shaped nail, the metal nail base is obtained by making nails with a magnesium alloy wire, the magnesium alloy wire has two upper-lower parallel surfaces; and the drug-loading film layer is composed of a porous oxide film containing drug molecules. According to the gastrointestinal anastomotic nail, the risk of nail breaking during the preparation and use process can be effectively reduced, meanwhile, through the cooperative use with drugs, the proliferation of tumorcells that may remain at an anastomotic site can be inhibited, the risk of recurrence is reduced or anastomotic stoma healing is promoted, and the occurrence of anastomotic stoma leakage is reduced.

Description

Technical field [0001] The invention relates to the technical field of medical devices, in particular to a gastrointestinal staple with a degradable drug film and a preparation method thereof. Background technique [0002] Anastomosis nails are commonly used medical devices to replace manual work and suture tissues or organs in clinic, especially in suture operations after partial gastrointestinal resection. At present, the most commonly used staples for staplers are made of titanium alloy materials, which have stable chemical properties and excellent mechanical properties, but titanium staples are non-degradable and permanent in the body, which will have a certain impact on patients' postoperative life. For example, long-term retention of titanium staples can affect medical imaging observations and cause local inflammation. [0003] In the postoperative recovery of actual gastrointestinal surgery, the staples only need to maintain mechanical support for 1-2 weeks, without long-te...

AI Technical Summary

Problems solved by technology

[0004] Chinese patent "ZL201610592979.5" provides a degradable staple and production process, which solves the problems of titanium staples and realizes the self-degradation and discharge of staples after surgery. However, its composition contains silver, which has no impact on the human body. Deterministic, and the staple in the acidic environment such as the gastrointestinal tract, its degradation rate may be too fast leading to premature failure

[0005] The Chinese patent "CN201911005516.4" provides an in vivo degradable staple. Its components are all essential elements of the human body, avoiding the influence of other elements on the human body, but it does not provide effective measures to improve corrosion resistance. It is also used in the gastrointestinal environment. There is a risk of premature degradation and failure in

[0006] At the same time, due to the physical and chemical properties of magnesium alloys, the magnesium alloy wire is prone to the risk of fracture during the bending process.

Even if it is not broken, due to the stress concentration at the bend, it is easy to preferentially degrade after being implanted in the human body environment, resulting in failure

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