CN111803721A

CN111803721A - Degradable zinc alloy anastomosis instrument and preparation method thereof

Info

Publication number: CN111803721A
Application number: CN202010565690.0A
Authority: CN
Inventors: 郑玉峰; 边东; 郭晖; 张余
Original assignee: Guangdong General Hospital
Current assignee: Guangdong General Hospital
Priority date: 2020-06-19
Filing date: 2020-06-19
Publication date: 2020-10-23

Abstract

The invention discloses a degradable zinc alloy anastomosis instrument and a preparation method thereof, wherein degradable Zn-Li-Mn-Y alloy is used as a material; the degradable Zn-Li-Mn-Y alloy contains 0-1 wt.% Li, 0-1 wt.% Mn and 0-1 wt.% Y, but does not contain 0, and the balance of Zn and inevitable impurities, and the degradable zinc alloy anastomosis instrument comprises any one of an absorbable suture, a medical zipper, an anastomosis nail, an anastomosis ring, an anastomosis clamp, an anastomosis sleeve or a vascular clamp. The degradable zinc alloy anastomosis instrument has excellent mechanical property, simple and convenient operation, firm anastomosis, uniform corrosion in tissues or organs, complete absorption by tissues and high tissue compatibility.

Description

Degradable zinc alloy anastomosis instrument and preparation method thereof

Technical Field

The invention belongs to the field of medical instruments, and particularly relates to a degradable zinc alloy anastomosis instrument and a preparation method thereof.

Background

The anastomotic device is a medical device for clinically replacing the traditional manual suture and is widely applied to the fields of clinical digestive tract anastomosis, skin suture and the like. The anastomosis instrument is simple and convenient to operate, has exact anastomosis, can shorten the operation anastomosis/suture time, and has fewer postoperative complications. At present, the anastomosis instrument which is mainly made of metal titanium clinically has enough mechanical strength and is firmly anastomosed; however, since titanium alloys are not degradable and remain permanently in the body, adverse reactions such as allergic reactions, chronic inflammation, tissue adhesion, and gastrointestinal bleeding may be caused. In addition, the presence of metal can cause metal artifacts under MRI, CT, which are not conducive to later tissue observation/examination. Therefore, the development of biodegradable anastomosis instruments can not only retain the technical advantages of the traditional anastomosis instruments, but also avoid the disadvantages/drawbacks, and has obvious advantages and application prospects.

Disclosure of Invention

The invention aims to overcome the defects in the prior art and provides a degradable zinc alloy anastomosis instrument and a preparation method thereof.

The purpose of the invention is realized by the following technical scheme:

a degradable zinc alloy anastomosis instrument is made of degradable Zn-Li-Mn-Y alloy; the degradable Zn-Li-Mn-Y alloy contains 0-1 wt.% of Li, 0-1 wt.% of Mn and 0-1 wt.% of Y, but does not include 0, and the balance of Zn and inevitable impurities.

More preferably, the Zn-Li-Mn-Y alloy contains 0 to 1 wt.% Li, 0 to 0.5 wt.% Mn and 0 to 0.5 wt.% Y, but does not include 0, and the balance is Zn and unavoidable impurities.

The preparation method of the degradable Zn-Li-Mn-Y alloy comprises the following steps:

(1) weighing Zn, Li, Mn and Y raw materials according to alloy components and a ratio, and fully mixing to obtain a mixture;

(2) using argon or CO₂And SF₆The mixed gas is used as a protective atmosphere, the mixture is smelted at the temperature of 440-620 ℃, and then a Zn-Li-Mn-Y alloy ingot is obtained after casting and cooling;

(3) and carrying out heat treatment and plastic processing on the Zn-Li-Mn-Y alloy cast ingot to obtain the sectional materials such as the Zn-Li-Mn-Y alloy block, the bar, the plate, the pipe or the wire.

The heat treatment is homogenization treatment; the plastic processing is extrusion processing, rolling processing or drawing processing and the like, and the plastic processing also comprises large plastic deformation technologies such as equal-diameter angular extrusion, high-pressure torsion, continuous extrusion and the like.

The homogenization treatment is to keep the temperature at 280-400 ℃ for enough time according to the size of the Zn-Li-Mn-Y alloy cast ingot to ensure that the core part is treated in place, and then carry out water quenching and cooling.

And in the extrusion treatment, the extrusion temperature is 200-300 ℃, the cast ingot is preheated to the extrusion temperature, the temperature of the core part is ensured, the extrusion ratio is controlled to be 12-50, the extrusion speed is 1-10 mm/s, and the extruded bars with different diameters are obtained.

And in the rolling treatment, the rolling temperature is 150-300 ℃, the pressing amount of each pass is controlled to be 5-30%, and plates with different thicknesses are obtained.

The drawing treatment is to obtain the Zn-Li-Mn-Y alloy wire with the diameter of 50-1000 mu m by a multi-pass continuous cold drawing process at room temperature, and the inter-pass annealing treatment is carried out at the temperature range of 150-300 ℃.

The preparation method of the degradable zinc alloy anastomosis instrument is characterized in that the Zn-Li-Mn-Y alloy material is processed into the anastomosis instrument with different shapes and structures in a bending, stamping, cutting, machining or assembling mode.

The degradable zinc alloy anastomosis instrument is any one of absorbable suture, a medical zipper, an anastomosis nail, an anastomosis ring, an anastomosis clamp, an anastomosis sleeve or a vascular clamp.

The anastomotic device can firmly perform anastomosis/suture/closure on tissues or organs by mechanical fixing modes such as knotting, incarceration, clasping, clamping, locking and the like, and is particularly suitable for the anastomosis/suture/closure of alimentary canal, blood vessel, nerve, skin, soft tissue and the like.

The degradable zinc alloy anastomosis instrument can be provided with active medicaments with therapeutic functions, including antibacterial active medicaments, procoagulant active medicaments and healing and tissue repair promoting active medicaments; the active drug can be released to surrounding tissues and organs under the action of body fluid, and plays a corresponding therapeutic role. The antibacterial active medicine is selected from clinical common antibiotics, such as tetracycline, gentamicin, penicillin, streptomycin or cephalosporin. The procoagulant active drug is selected from common clinical procoagulant drugs such as etamsylate, norepinephrine, somatostatin, vitamin K1, thrombin or fibrinogen and the like. The healing promoting and tissue repair promoting active medicine is selected from vitamin B12, human epidermal growth factor or chitosan, etc.

The degradable zinc alloy anastomosis instrument can be provided with a groove or a hole, and the active medicine can be filled in the groove or the hole. The active drug can also be attached to the surface of the degradable zinc alloy anastomosis device in the form of a surface coating/film layer.

The principle of the invention is as follows:

(1) zinc is one of the most basic essential trace elements of human body, almost participates in all physiological metabolic processes, and has good biocompatibility. Zinc can promote cell renewal, enhance immunity, maintain growth and development of human body, and promote wound healing. The standard electrode potential of zinc is-0.763V, which is between magnesium (-2.37V) and iron (-0.44V), the corrosion rate of zinc is also between magnesium and iron, and the corrosion rate meets the requirement of clinical degradable implants. However, pure zinc has poor comprehensive mechanical properties, and is difficult to be directly used as an implant material or an instrument for clinical application.

(2) Alloying can significantly improve the strength of zinc and maintain excellent ductility and corrosion resistance. Lithium (Li) element can significantly improve the strength of zinc, but too much Li causes a large reduction in elongation. The manganese (Mn) element can significantly improve the plasticity of zinc. By adding a proper amount of Li and Mn together, the zinc alloy with better matching strength and plasticity can be obtained. Moreover, the research also finds that the rare earth element yttrium (Y) can also obviously strengthen the zinc alloy. The introduction of a small amount of Y can ensure that the total usage amount of alloy elements is reduced to the maximum extent on the premise of obtaining the required performance, thereby promoting the safety and the effectiveness.

(3) Zinc, lithium and manganese are all trace elements necessary for human bodies, are closely related to life activities and body health, and the biological safety of a small amount of rare earth Y is also verified in the degradable magnesium alloy implant. Therefore, the low-alloyed Zn-Li-Mn-Y alloy also has good biocompatibility and safety. By adjusting the alloy components and the cold and hot treatment process, the mechanical property and the corrosion behavior of the Zn-Li-Mn-Y alloy can be regulated and controlled in a wide range so as to be applied to different physiological environments. The low-alloying Zn-Li-Mn-Y alloy has good obdurability and processability, can be made into different sectional materials and further processed into different types of degradable implant materials or instruments.

(4) The anastomotic device made of Zn-Li-Mn-Y alloy can be gradually degraded and absorbed along with the healing of the anastomotic stoma, and finally has no residue. Furthermore, active drugs with therapeutic effects are added in or on the surface of the anastomosis instrument made of Zn-Li-Mn-Y alloy, and the anastomosis instrument can also play roles in diminishing inflammation, stopping bleeding, preventing infection, promoting healing and the like, is firm in anastomosis, small in scar, safe, effective and strong in clinical practicability.

Compared with the prior art, the invention has the following advantages and effects:

(1) the degradable zinc alloy anastomosis instrument is simple and convenient to operate, firm in anastomosis and high in tissue compatibility, can be completely absorbed by tissues, and does not need to be taken out in a secondary operation.

(2) The degradable zinc alloy anastomosis instrument can promote healing and repair of an anastomosis, can reduce and avoid complications related to the anastomosis, and can avoid or reduce adverse reactions after anastomosis operations.

(3) The degradable zinc alloy anastomosis instrument can exist in various different forms and structures, can regulate and control the degradation performance of Zn-Li-Mn-Y alloy, and has wide application range.

(4) The degradable zinc alloy anastomosis instrument is compatible with imaging examination such as MRI, CT and the like, and after the instrument is degraded, artifacts disappear, thereby being beneficial to later-stage tissue observation/examination.

Drawings

FIG. 1 shows a degradable Zn-Li-Mn-Y alloy anastomosis instrument (suture for anastomosis), which is characterized in that (a) suture is knotted, and (b) suture is looped.

Fig. 2 shows a degradable Zn-Li-Mn-Y alloy anastomosis instrument (U-shaped anastomosis nail), (a) in an original state (U-shaped) and (B) in an anastomosis state (B-shaped).

Fig. 3 shows the degradation of degradable Zn-Li-Mn-Y alloy anastomosis instruments (U-shaped anastomosis nails) at 3d, 8w and 12w after the stomach-intestine anastomosis of the fragrant pig.

Fig. 4 shows a drug-loaded degradable Zn-Li-Mn-Y alloy anastomosis instrument (drug-loaded U-shaped anastomosis nail). In the figure, 1, a hollow nail; 2. an active agent; 3. the channel is released.

Detailed Description

In order that the invention may be readily understood, reference will now be made in detail to the specific embodiments of the invention. The following examples will assist those skilled in the art in further understanding the invention, but are not intended to limit the invention in any way. It should be noted that, for a person skilled in the art, many variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention.

Unless defined otherwise, all technical and scientific terms used herein are to be interpreted as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

The detection method adopted in the embodiment is as follows:

1. tensile tests were carried out at room temperature using a universal material tester (Instron 5969, USA). The tensile rate was 1mm/min and Yield Strength (YS), defined as the stress at which the sample undergoes 0.2% plastic deformation, tensile strength (UTS) and elongation (El.) data were obtained from the tensile stress-strain curve.

2. Anastomotic burst pressure test

An in vitro anastomotic burst pressure test was performed using fresh porcine large intestine, briefly operated as follows: after the anastomosis nail is nailed into a gastrointestinal anastomat, one end of the large intestine of the pig is anastomosed; and then the other end of the pressure gauge is connected with a water injection device to inject water into the large intestine at a constant speed, and the large intestine and the pressure gauge are ensured to be positioned on the same horizontal plane. And observing the change of the anastomotic opening, and recording the reading on the pressure gauge at the moment as the bursting pressure of the anastomotic opening when water overflows from the anastomotic opening.

3. Gastrointestinal anastomosis animal experiment

Selecting a 6-month-old female fragrant pig (with the weight of 30-35 kg) as an animal model for experiment, performing gastrointestinal anastomosis by using an anastomosis nail, fasting the animal for 1d before operation, performing anesthesia intubation, removing hair on the upper abdomen, sterilizing the skin, and paving a sterile paving towel. A median incision of the abdomen is made, about 7cm long, and a stomach-jejunum anastomosis operation is performed. Cutting off the junction of pylorus and duodenum, closing the remnant of duodenum with a closer, lifting the jejunum about 40cm away from the pylorus, cutting the side wall of jejunum, embedding a nail anvil of a tubular anastomat in a purse-string suture manner, placing the stomach remnant into an anastomat main body, performing stomach-jejunum side anastomosis at the side of the greater curvature of the stomach, suturing the stomach remnant with suture, and suturing the abdomen after hemostasis is achieved. Postoperative conventional anti-infection, fluid infusion and other symptomatic support treatments. Animals were given free water after surgery and food was restored 3d after surgery. The fragrant pigs were euthanized at 3d, 8w and 12w after surgery, and the materials were taken for subsequent experimental characterization.

The implanted staples were scanned using a micro-CT (Skyscan 1172, Bruker) system at a scan voltage of 80kV, step size of 0.4 °, Al 0.5 filter and resolution of 6.7 μm. Three-dimensional reconstruction was performed using skyscan nreco software (Kontich, Belgium), and data analysis was performed using CTAn and CTVol software, observing the degradation of the staples, and calculating the implant residual volume fraction.

After dehydration of the samples with gradient alcohol (70%, 80%, 90%, 95% and 100%), they were embedded with polymethyl methacrylate (PMMA). And cutting the hard tissue into hard tissue slices with the thickness of 150 mu m along the direction of the maximum section of the staple, and then grinding and polishing the hard tissue slices to the thickness of 40-60 mu m. Subsequently, histological analysis was performed after staining with hematoxylin-eosin (H & E). The major organs of the animals were also fixed, dehydrated, paraffin embedded and sectioned, and all soft tissue sections were stained with H & E. Histopathological analysis was performed by observation under an optical microscope (Olympus BX51, Japan).

Example 1

Pure Zn (more than or equal to 99.9 wt.%), pure Li (more than or equal to 99.9 wt.%), pure Mn (more than or equal to 99.9 wt.%), and pure Y (more than or equal to 99.9 wt.%) are selected as raw materials, and smelting is carried out in a medium-frequency induction furnace. By using CO₂And SF₆And (3) taking the mixed gas as a protective atmosphere, heating the raw materials to 580 ℃, stirring the melt, and casting the homogenized melt to obtain the Zn-0.8Li-0.1Mn-0.1Y alloy ingot. And keeping the temperature of the cast ingot at 350 ℃ for 48 hours, and then cooling with water. Preheating the cast ingot to 250 ℃, controlling the extrusion ratio to be 25 and the extrusion speed to be 1mm/s, and obtaining the extrusion Zn-0.8Li-0.1Mn-0.1Y alloy bar with the diameter of 3 mm. Then, multi-pass continuous cold drawing treatment is carried out at room temperature, and annealing is carried out at 250 ℃ between passes, so that the Zn-0.8Li-0.1Mn-0.1Y alloy wire with the diameter of 0.3mm is finally obtained. The degradable Zn-0.8Li-0.1Mn-0.1Y alloy suture is obtained after the wire is packaged and sterilized by Co-60 gamma rays, as shown in figure 1. YS, UTS and El. of the suture are 393.5MPa, 535.1MPa and 71.2 percent respectively, and the performance of the suture is equivalent to that of the degradable suture sold on the market at present. The degradable Zn-0.8Li-0.1Mn-0.1Y alloy suture has good mechanical strength and ductility, is firmly knotted and meets the suture requirement. The suture has high tissue compatibility, can reduce tissue edema and infection risk, and is suitable for suturing various tissues and organs.

Example 2

Pure Zn (more than or equal to 99.9 wt.%), pure Li (more than or equal to 99.9 wt.%), pure Mn (more than or equal to 99.9 wt.%), and pure Y (more than or equal to 99.9 wt.%) are selected as raw materials, and smelting is carried out in a medium-frequency induction furnace. By using CO₂And SF₆And heating the mixed gas as a protective atmosphere to 500-600 ℃, melting the raw materials, and casting the homogenized melt to obtain a Zn-0.5Li-0.5Mn-0.2Y alloy ingot. And keeping the temperature of the cast ingot at 350 ℃ for 48 hours, and then cooling with water. Preheating the cast ingot to 250 ℃, controlling the extrusion ratio to be 36 and the extrusion speed to be 1mm/s, and obtaining the extrusion Zn-0.5Li-0.5Mn-0.2Y alloy bar with the diameter of 3 mm. And then, carrying out multi-pass continuous cold drawing treatment on the extruded bar at room temperature, and annealing at 250 ℃ between passes to finally obtain the Zn-0.5Li-0.5Mn-0.2Y alloy wire with the diameter of 0.3 mm. And bending the Zn-0.5Li-0.5Mn-0.2Y alloy wire into a U shape on a special die, and cutting off two ends to obtain the degradable Zn-0.5Li-0.5Mn-0.2Y alloy anastomosis nail. The original staple is in a U shape, the legs of the staple are deformed, and the stapled staple forms a B shape as shown in fig. 2.

According to the external anastomotic stoma bursting pressure test, the anastomotic stoma bursting pressure of the Zn-0.5Li-0.5Mn-0.2Y alloy anastomotic nail is 33kPa, which is equivalent to the anastomotic stoma bursting pressure of common titanium alloy anastomotic nail. The zinc alloy anastomosis nail is used for performing anastomosis on the stomach and the jejunum of the fragrant pig, and the degradable Zn-0.5Li-0.5Mn-0.2Y alloy anastomosis nail can easily penetrate through gastrointestinal tissues in the operation process, so that the anastomosis effect is good, and the nail fracture condition is not generated. After operation, anastomotic stoma healing is good, no obvious stenosis is seen, anastomotic fistula is not generated, scars are slight, no abnormity is caused when the fragrant pig is orally taken, and the growth state is good. After operation, the leg part of the anastomotic nail is obviously degraded under micro-CT (micro-computed tomography) at 8w, and after operation, the leg part is seriously degraded under 12w, and part of the leg is completely dissolved, as shown in figure 3. At this point, the volume of the residual staples was 89% of the initial volume, and the structural integrity of the staples gradually decreased, with the expectation that the staples will completely degrade within 1 year. And a small amount of inflammatory cell infiltration is observed around the anastomosis nail after 3 days of operation, which indicates that the degradable Zn-0.5Li-0.5Mn-0.2Y alloy anastomosis nail has slight inflammatory reaction. After operation 12w, fibrous tissues are wrapped around the staples, and obvious degradation of the staples can be observed on the section. After the operation, the concentration of the zinc ions in the serum is stable, the concentration is not obviously different from that before the operation, and the pathological section of the main organ (heart, liver, spleen, lung and kidney) is normal, which shows that the degradable Zn-0.5Li-0.5Mn-0.2Y alloy anastomosis nail has no local or systemic toxicity.

Example 3

According to the method described in example 1 and example 2, Zn-0.4Li-0.2Mn-0.1Y alloy ingots were obtained, and the ingots were kept at 350 ℃ for 48 hours, and then quenched with water and cooled. And (3) machining the cast ingot to obtain a hollow cylindrical tube blank, performing multi-pass drawing treatment on the tube blank at 200-300 ℃, and annealing at 250 ℃ between passes to finally obtain a hollow Zn-0.4Li-0.2Mn-0.1Y alloy micro-tube with the diameter less than 1 mm. After the Zn-0.4Li-0.2Mn-0.1Y alloy micro-tube is polished and cleaned, the micro-tube is filled with therapeutic drugs for antibiotics, procoagulant blood, promoting healing or promoting tissue repair. The Zn-0.4Li-0.2Mn-0.1Y alloy micro-tube is bent into a U shape on a special die, the two ends of the U shape are cut off to obtain the degradable Zn-0.4Li-0.2Mn-0.1Y alloy anastomosis nail, and drug release channels can be arranged at different positions of the anastomosis nail. As shown in fig. 4, the staple is composed of a hollow nail 1 of Zn-0.4Li-0.2Mn-0.1Y alloy bent into a U shape, an active drug 2 filled in the hollow nail, and a release channel 3 for the active drug. Under the action of body fluid, the active medicine can be released into the surrounding tissues through two ends of the U-shaped anastomosis staple, and the corresponding treatment effect is achieved. The drug-loaded Zn-0.4Li-0.2Mn-0.1Y alloy anastomosis nail is firm in anastomosis, uniform in corrosion in tissues or organs, high in tissue compatibility, capable of avoiding complications (stenosis, bleeding, fistula and the like) related to an anastomosis, capable of promoting healing and repair of the anastomosis, and capable of avoiding or reducing adverse reactions after anastomosis operations such as chronic inflammation, bacterial infection and the like.

Comparative example 1

Pure Zn (more than or equal to 99.9 wt.%) is selected as a raw material, and smelting is carried out in a medium-frequency induction furnace. By using CO₂And SF₆And (3) taking the mixed gas as a protective atmosphere, heating the raw materials to 600 ℃, stirring the melt, and pouring the homogenized melt to obtain a pure Zn ingot. The homogenization heat treatment is carried out at 350 ℃, and the water cooling is carried out after the heat preservation is carried out for 48 hours. Preheating the cast ingot to 250 ℃, controlling the extrusion ratio to be 25 and the extrusion speed to be 1mm/s, and obtaining the extruded pure Zn bar with the diameter of 3 mm. Subsequently, multi-pass continuous cold drawing treatment is carried out at room temperature, and annealing is carried out at 250 ℃ between passes, so that the pure Zn wire with the diameter of 0.3mm is finally obtained. Packaging pure Zn wire and sterilizing by Co-60 gamma rayThen obtaining the degradable pure Zn suture.

YS, UTS and El. of the pure Zn suture are 73.6MPa, 100.1MPa and 16.0 percent respectively, and the strength and the elongation are obviously lower than those of the degradable Zn-0.8Li-0.1Mn-0.1Y alloy suture in the example 1. After the pure Zn suture is knotted, tiny fine lines appear on the surface of the knotted suture, which may be unfavorable to the mechanical property and the degradation property of the suture, and the fracture of the suture may occur before the tissue is healed, thereby causing the suture failure.

Comparative example 2

Commercial titanium alloy (Ti6Al4V) wire with the diameter of 0.3mm is purchased, the titanium alloy wire is bent into a U shape on a special die, and the titanium alloy anastomosis nail is obtained after the two ends are cut off. Through in vitro anastomotic stoma burst pressure tests, the anastomotic stoma burst pressure of the titanium alloy anastomotic nail is 34kPa, which is equivalent to the degradable Zn-0.5Li-0.5Mn-0.2Y alloy anastomotic nail in the embodiment 2. It can be seen that the performance of the present invention is comparable to that of existing commercial titanium alloy anastomosis instruments.

The stomach-jejunum of the fragrant pig is anastomosed by using the titanium alloy anastomosis nail, and a small amount of inflammatory cell infiltration, which is mainly neutrophilic granulocytes and lymphocytes and occasionally a small amount of macrophages, is observed around the titanium alloy anastomosis nail after 3d of operation, so that a moderate inflammatory reaction is prompted. 12w after operation, the titanium alloy anastomosis nail is wrapped by fibrous tissues, the number of inflammatory cells is obviously reduced, and the healing state of the anastomosis is good without obvious stenosis.

Compared with the degradable Zn-0.5Li-0.5Mn-0.2Y alloy staple in the embodiment 2, the diameter of the stomach-intestine anastomosis of the titanium alloy staple is slightly smaller than that of the degradable Zn-0.5Li-0.5Mn-0.2Y alloy staple, but the difference is not significant. Meanwhile, the degradable Zn-0.5Li-0.5Mn-0.2Y alloy anastomosis nail has slight inflammatory reaction and slightly small scar tissue. The above results show that the degradable zinc alloy anastomosis nail has good anastomosis performance and tissue compatibility.

The above description is only an example of the present invention, but the present invention is not limited to the above example, and any other changes, modifications, substitutions, combinations, and simplifications which do not depart from the spirit and principle of the present invention and are equivalent to each other are included in the protection scope of the present invention.

Claims

1. A degradable zinc alloy anastomat is characterized in that: degradable Zn-Li-Mn-Y alloy is used as a material; the degradable Zn-Li-Mn-Y alloy contains 0-1 wt.% of Li, 0-1 wt.% of Mn and 0-1 wt.% of Y, but does not include 0, and the balance of Zn and inevitable impurities.

2. The degradable zinc alloy anastomosis instrument of claim 1, wherein: the Zn-Li-Mn-Y alloy contains 0 to 1 wt.% Li, 0 to 0.5 wt.% Mn and 0 to 0.5 wt.% Y, but excluding 0, and the balance Zn and unavoidable impurities.

3. The degradable zinc alloy anastomosis instrument of claim 1, wherein: the preparation method of the degradable Zn-Li-Mn-Y alloy comprises the following steps:

(3) and carrying out heat treatment and plastic processing on the Zn-Li-Mn-Y alloy cast ingot to obtain a Zn-Li-Mn-Y alloy block, a bar, a plate, a pipe or a wire.

4. The degradable zinc alloy anastomosis instrument of claim 3, wherein: the heat treatment is homogenization treatment; the plastic processing is extrusion processing, rolling processing, drawing processing, equal channel angular extrusion, high-pressure torsion or continuous extrusion.

5. The degradable zinc alloy anastomosis instrument of claim 1, wherein: is any one of absorbable suture, medical zipper, anastomosis nail, anastomosis ring, anastomosis clip, anastomosis sleeve or vascular clip.

6. The degradable zinc alloy anastomosis instrument of claim 1, wherein: active agents having therapeutic functions may be disposed thereon, including antibacterial active agents, procoagulant active agents, and healing and tissue repair promoting active agents.

7. The degradable zinc alloy anastomosis instrument of claim 6, wherein: the degradable zinc alloy anastomosis instrument is provided with a groove or a hole, and the active medicine can be filled in the groove or the hole.

8. The degradable zinc alloy anastomosis instrument of claim 6, wherein: the active drug is attached to the surface of the degradable zinc alloy anastomosis instrument in the form of a surface coating/film layer.

9. The preparation method of the degradable zinc alloy anastomosis instrument of any one of claims 1 to 8, which is characterized by comprising the following steps: the Zn-Li-Mn-Y alloy material is processed into the anastomosis instruments with different shapes and structures in the modes of bending, stamping, cutting, machining or assembling.