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

A technology for gastrointestinal anastomosis and staples, which is applied in the field of medical devices, can solve the problems of easy fracture of magnesium alloy wires, no corrosion resistance measures, and too fast degradation rate, so as to avoid rapid degradation and solve long-term retention problems. Problems and negative effects, the effect of promoting healing

Pending Publication Date: 2020-10-13
PEOPLES HOSPITAL PEKING UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] The preparation method of the gastrointestinal staple with degradable drug film of the present invention is as follows:

[0049] 1) Select a magnesium alloy ingot with a zinc content of 2wt% (the balance is magnesium and unavoidable impurities), and perform hot extrusion at 360°C with an extrusion ratio of 20:1 to obtain magnesium alloy bars;

[0050] 2) The magnesium alloy bar obtained in step 1) is subjected to multi-pass drawing deformation and annealed at 200°C to obtain a magnesium alloy wire with a diameter of 0.2mm;

[0051] 3) Perform precision hot rolling of the magnesium alloy wire obtained in step 2) at a rolling temperature of 100°C and a reduction ratio of 10% of the diameter to obtain a magnesium alloy wire with an elliptical cross-section;

[0052] 4) Continuously anodize the magnesium alloy wire with elliptical cross-section obtained in step 3), and the treatment time per unit length of the wire is 10 minutes.

[0053] 5) Nail the magnesium alloy wire processed in...

Embodiment 2

[0058] The preparation method of the gastrointestinal staple with degradable drug film of the present invention is as follows:

[0059] 1) Select a magnesium alloy ingot with a zinc content of 2wt% (the balance is magnesium and unavoidable impurities), and perform hot extrusion at 380°C with an extrusion ratio of 20:1 to obtain magnesium alloy bars;

[0060] 2) The magnesium alloy bar obtained in step 1) is subjected to multi-pass drawing deformation and annealed at 250°C to obtain a magnesium alloy wire with a diameter of 0.2mm;

[0061] 3) Precisely hot-roll the magnesium alloy wire obtained in step 2) at a rolling temperature of 100°C and a reduction ratio of 15% of the diameter to obtain a magnesium alloy wire with an elliptical cross-section;

[0062] 4) Continuously anodize the magnesium alloy wire with elliptical cross-section obtained in step 3), and the treatment time per unit length of the wire is 10 minutes.

[0063] 5) Nail the magnesium alloy wire processed in step 4) to ob...

Embodiment 3

[0068] The preparation method of the gastrointestinal staple with degradable drug film of the present invention is as follows:

[0069] 1) Select a magnesium alloy ingot with a zinc element content of 2wt% and a calcium element content of 0.5% (the balance is magnesium and unavoidable impurities), and perform hot extrusion at 400°C with an extrusion ratio of 20:1. Obtain magnesium alloy bars;

[0070] 2) The magnesium alloy bar obtained in step 1) is subjected to multi-pass drawing deformation, and annealed at 270°C to obtain a magnesium alloy wire with a diameter of 0.3mm;

[0071] 3) Perform precision hot rolling of the magnesium alloy wire obtained in step 2) at a rolling temperature of 100°C and a reduction ratio of 18% of the diameter to obtain a magnesium alloy wire with an elliptical cross-section;

[0072] 4) Continuously anodize the magnesium alloy wire with elliptical cross-section obtained in step 3), and the treatment time per unit length of the wire is 10 minutes.

[0073]...

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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...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61B17/064A61L31/16A61L31/02A61L31/08A61L31/10A61L31/14C25D11/30C22F1/06C21D9/52C22C23/04C22C23/00
CPCA61B17/064A61B2017/00526A61B2017/00893A61L31/022A61L31/08A61L31/10A61L31/14A61L31/146A61L31/16A61L2300/216A61L2300/414A61L2300/416A61L2300/604A61L2300/606A61L2400/12A61L2400/18A61L2420/02C21D9/525C22C23/00C22C23/04C22F1/06C25D11/30C08L89/00
Inventor 曹键程兆俊叶颖江姜可伟杨晓东白晶邵怡
Owner PEOPLES HOSPITAL PEKING UNIV
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