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Biodegradable zinc alloy anastomotic apparatus and preparation method thereof

A zinc alloy and device technology, applied in the field of degradable zinc alloy anastomotic devices and its preparation, can solve problems such as allergic reactions, unfavorable tissue observation/inspection, non-degradable titanium alloys, etc.

Inactive Publication Date: 2020-10-23
GUANGDONG GENERAL HOSPITAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the anastomotic instruments made of titanium metal are mainly used clinically, which have sufficient mechanical strength and reliable anastomosis; however, because titanium alloys are not degradable, they remain permanently in the body, which may cause allergic reactions, chronic inflammation, tissue adhesion and digestion. Tract bleeding and other adverse reactions
In addition, the existence of metal will cause metal artifacts under MRI and CT, which is not conducive to the later tissue observation / examination

Method used

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  • Biodegradable zinc alloy anastomotic apparatus and preparation method thereof
  • Biodegradable zinc alloy anastomotic apparatus and preparation method thereof
  • Biodegradable zinc alloy anastomotic apparatus and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Select pure Zn (≥99.9wt.%), pure Li (≥99.9wt.%), pure Mn (≥99.9wt.%), pure Y (≥99.9wt.%) as raw materials, and melt in a medium frequency induction furnace . Using CO 2 and SF 6 The mixed gas is used as a protective atmosphere, the raw material is heated to 580° C., the melt is stirred, and the homogenized melt is poured to obtain a Zn-0.8Li-0.1Mn-0.1Y alloy ingot. The ingots were kept at 350°C for 48 hours and then water-cooled. The ingot was preheated to 250°C, the extrusion ratio was controlled to 25, and the extrusion speed was 1mm / s to obtain an extruded Zn-0.8Li-0.1Mn-0.1Y alloy rod with a diameter of 3mm. Subsequently, multiple passes of continuous cold drawing were performed at room temperature, and annealed at 250° C. between passes to finally obtain a Zn-0.8Li-0.1Mn-0.1Y alloy wire with a diameter of 0.3 mm. The degradable Zn-0.8Li-0.1Mn-0.1Y alloy sutures were obtained after the filament was encapsulated and sterilized by Co-60 gamma rays, such as figure...

Embodiment 2

[0048] Select pure Zn (≥99.9wt.%), pure Li (≥99.9wt.%), pure Mn (≥99.9wt.%), pure Y (≥99.9wt.%) as raw materials, and melt in a medium frequency induction furnace . Using CO 2 and SF 6 The mixed gas is used as a protective atmosphere, and the temperature is raised to 500-600° C. to melt the raw materials, and the homogenized melt is poured to obtain a Zn-0.5Li-0.5Mn-0.2Y alloy ingot. The ingots were kept at 350°C for 48 hours and then water-cooled. The ingot was preheated to 250°C, the extrusion ratio was controlled to be 36, and the extrusion speed was 1mm / s to obtain extruded Zn-0.5Li-0.5Mn-0.2Y alloy rods with a diameter of 3mm. Subsequently, the extruded bar was subjected to multiple passes of continuous cold drawing at room temperature, and annealed at 250°C between passes to finally obtain a Zn-0.5Li-0.5Mn-0.2Y alloy wire with a diameter of 0.3mm material. The Zn-0.5Li-0.5Mn-0.2Y alloy wire is bent into a U shape on a special mold, and the degradable Zn-0.5Li-0.5Mn-...

Embodiment 3

[0051] According to the method described in Example 1 and Example 2, a Zn-0.4Li-0.2Mn-0.1Y alloy ingot was obtained, and the ingot was kept at 350° C. for 48 hours and then cooled by water quenching. The ingot is machined to obtain a hollow cylindrical tube blank. The tube blank is subjected to multi-pass drawing treatment at 200-300°C, and annealed at 250°C between passes, and finally a hollow Zn-0.4Li-0.2 with a diameter of Figure 4 As shown, the staple is composed of a U-shaped Zn-0.4Li-0.2Mn-0.1Y alloy hollow nail 1, an active drug 2 filled in the hollow nail and a release channel 3 for the active drug. constitute. Under the action of the body fluid, the active drug can be released into the surrounding tissue through the two ends of the U-shaped staple to achieve a corresponding therapeutic effect. The drug-loaded Zn-0.4Li-0.2Mn-0.1Y alloy staple has firm anastomosis, uniform corrosion in tissues or organs, high tissue compatibility, and can avoid anastomosis-related comp...

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Abstract

The invention discloses a degradable zinc alloy anastomotic apparatus and a preparation method thereof. The degradable zinc alloy anastomotic apparatus uses a degradable Zn-Li-Mn-Y alloy as a material, and the degradable Zn-Li-Mn-Y alloy includes the following components: 0-1 wt.% of Li, 0-1 wt.% of Mn and 0-1 wt.% of Y, without including 0, and the rest are Zn and unavoidable impurities. The degradable zinc alloy anastomotic apparatus includes any one of absorbable suture, medical zipper, anastomotic nail, anastomotic ring, anastomotic clip, anastomotic cannula or vascular clamp. The degradable zinc alloy anastomotic apparatus of the invention is excellent in mechanical properties, simple and convenient in operation, firm in anastomosis, capable of being decomposed in tissues or organs, capable of being fully absorbed by tissues and high in tissue compatibility.

Description

technical field [0001] The invention belongs to the field of medical devices, and in particular relates to a degradable zinc alloy anastomotic device and a preparation method thereof. Background technique [0002] The anastomosis instrument is a medical device that can replace the traditional manual suture clinically, and is widely used in the fields of clinical gastrointestinal anastomosis and skin suture. The anastomotic instrument is easy to operate, accurate in anastomosis, can shorten the time of surgical anastomosis / suture, and has fewer postoperative complications. At present, the anastomotic instruments made of titanium metal are mainly used clinically, which have sufficient mechanical strength and reliable anastomosis; however, because titanium alloys are not degradable, they remain permanently in the body, which may cause allergic reactions, chronic inflammation, tissue adhesion and digestion. Adverse reactions such as tract bleeding. In addition, the existence o...

Claims

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Application Information

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IPC IPC(8): A61L31/14A61L31/02A61L31/16A61L17/06A61L17/00C22C18/00C22C1/02C22F1/16
CPCA61L17/005A61L17/06A61L31/022A61L31/14A61L31/148A61L31/16A61L2300/102A61L2300/404A61L2300/412A61L2300/418A61L2300/426C22C1/02C22C18/00C22F1/165
Inventor 郑玉峰边东郭晖张余
Owner GUANGDONG GENERAL HOSPITAL
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