阅读说明：本技术 一种可降解锌合金吻合器械及其制备方法 (Degradable zinc alloy anastomosis instrument and preparation method thereof ) 是由 郑玉峰 边东 郭晖 张余 于 2020-06-19 设计创作，主要内容包括：本发明公开了一种可降解锌合金吻合器械及其制备方法,是以可降解Zn-Li-Mn-Y合金为材质；所述可降解Zn-Li-Mn-Y合金的成分上含有0～1wt.％Li、0～1wt.％Mn和0～1wt.％Y,但不包括0,其余为Zn及不可避免杂质,该可降解锌合金吻合器械包括可吸收缝线、医用拉链、吻合钉、吻合环、吻合夹、吻合套管或血管夹中的任意一种。本发明的可降解锌合金吻合器械具有优异的力学性能,操作简便,吻合牢靠,在组织或器官中腐蚀均匀,可被组织完全吸收,组织兼容性高。(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.)

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:

(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 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.

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.