Preparation method of degradable rare earth-containing iron-based medical material for cholangioenteric anastomat

Abstract

The present application belongs to the technical field of biomedical metal, and particularly relates to a preparation method of a degradable rare earth-containing iron-based medical material for a cholangioenteric anastomat, wherein the degradable rare earth-containing iron-based medical material comprises the following components in percentage by mass: Mn: 30-40%, Ge: 3-10%, RE: 0.02-1%, and the balance of Fe. The present application has the advantages of higher mechanical properties, a degradation rate more suitable for wound healing, more excellent blood compatibility, cell compatibility and antibacterial performance, and is expected to become a potential degradable biomedical material.

Description

Technical Field

[0001] This invention relates to the field of biomedical metal technology, and in particular to a method for preparing a biodegradable rare earth iron-based medical material for use in choledochoenterostomy devices. Background Technology

[0002] Currently, cholecystectomy is a treatment for patients with gallbladder polyps, gallstones, and even gallbladder cancer. However, literature reports that cholecystectomy can cause indigestion and decreased immunity, and significantly increase the incidence of colon cancer. Therefore, there is a growing demand in clinical practice for gallbladder preservation and choledochojejunostomy. In gastrointestinal anastomosis, surgical staples are widely used for healing and reconstruction of the gastrointestinal tract. Staplers are a medical device used clinically to replace traditional sutures. Compared with manual suturing, using staples can shorten the gastrointestinal anastomosis operation time and reduce postoperative complications and patient pain. Although biodegradable sutures are widely used, non-degradable titanium alloy (Ti-6Al-4V) and medical-grade stainless steel (631 precipitated stainless steel) staples are still widely used in surgical procedures. Although non-degradable staples have sufficient mechanical strength and hardness, their long-term presence in the human body may cause adverse reactions such as allergic reactions, allogeneic reactions, and tissue adhesions. Furthermore, non-degradable metals have a high X-ray absorption coefficient, causing artifacts and interfering with postoperative examinations. Therefore, developing biodegradable metallic materials with controllable degradation behavior is an urgent task.

[0003] Pure iron (Fe) possesses good mechanical strength and low cost, but its slow degradation rate and strong paramagnetism result in a prolonged degradation cycle in vivo and interference with MRI detection. Therefore, developing iron-based alloys with faster degradation rates, non-magnetic properties, and high biocompatibility is imperative. Manganese (Mn) alloying can significantly improve the degradation rate, mechanical properties, and reduce paramagnetism of pure iron. Furthermore, Mn is an essential element for the human body, contributing to normal brain and nerve function and bone formation. Germanium (Ge), belonging to the same group as silicon (Si), exhibits similar physicochemical properties and can stabilize the austenitic phase in steel, maintaining the non-magnetic nature of Fe-Mn alloys. The main attraction of rare earth elements in metals lies in their significant impact on the mechanical, corrosion, creep, and other physical properties of the matrix alloy. Due to their unique electronic structure, rare earth elements can significantly refine grain size and form new second phases, improving the mechanical properties, hardness, and wear resistance of biodegradable metals, resulting in rare earth-containing biodegradable metals with excellent mechanical properties. Rare earth elements, with their active chemical properties, react with harmful elements such as O, H, and S, as well as metallic elements such as Co and Ni, in molten metal to form slag, which purifies the melt and removes gas.

[0004] Currently, there are no reports in domestic or international literature on the preparation and performance of biodegradable rare earth iron-based medical materials for choledochoenterostomy devices. Therefore, it is proposed to use biodegradable rare earth iron-based medical materials as the next stage of biodegradable biomedical materials. Summary of the Invention

[0005] In view of the shortcomings of the existing technology, the purpose of this invention is to provide a method for preparing a biodegradable rare earth iron-based medical material for choledochoenterostomy devices, so as to solve the above problems.

[0006] The technical solution of the present invention is as follows: a method for preparing a biodegradable rare earth iron-based medical material for a choledochoenterostomy device. The biodegradable rare earth iron-based medical material comprises the following components by mass percentage: Mn: 30-40%, Ge: 3-10%, RE: 0.02-1%, and the balance being Fe.

[0007] Furthermore, RE can be one or more of the following: lanthanum (La), cerium (Ce), praseodymium (Pr), neodymium (Nd), europium (Eu), gadolinium (Gd), terbium (Tb), dysprosium (Dy), holmium (Ho), erbium (Er), thulium (Tm), ytterbium (Yb), and lutetium (Lu).

[0008] Furthermore, the composition of the biodegradable rare earth iron-based medical material raw material includes the following components: high-purity iron blocks (99.99%), micro-carbon manganese iron blocks (containing 20% ​​Fe, 0.05% C and the balance of Mn), single-crystal germanium particles (99.999%), and rare earth rods / particles / blocks (99.99%).

[0009] Furthermore, the micro-carbon manganese iron block comprises the following components by mass percentage: Fe: 20%, 0.05% C, with the balance being Mn.

[0010] Furthermore, a method for preparing a biodegradable rare-earth iron-based medical material for a choledochoenterostomy device includes the following steps:

[0011] a. Take high-purity iron blocks, micro-carbon manganese iron blocks, single-crystal germanium particles, and rare earth rods / particles / blocks as raw materials;

[0012] b. According to the burn-off rate and the Fe-Mn-Ge-RE mass percentage, mix them, put them into an alumina crucible and place them in a vacuum induction melting furnace;

[0013] c. Turn on the mechanical pump and molecular pump in the vacuum arc melting furnace. After the vacuum degree in the vacuum induction melting furnace drops to 1 to 10 × 10-3 Pa, introduce argon gas with a purity of 99.99% to raise the argon gas pressure to 10 to 100 kPa. Then, under the protection of argon gas, heat the alumina crucible containing the raw materials at 1000 to 1400°C to melt it into molten steel.

[0014] d. After the molten steel has been fully melted, continue heating for 5 to 30 minutes, pour it into a 200mm×20mm×20mm high-purity graphite mold in the furnace, and finally air-cool it to room temperature before depressurizing and taking out the Fe-Mn-Ge-RE alloy ingot.

[0015] Next, the ingot is placed in a muffle furnace heated to 800-1000℃ for homogenization annealing for 2-10 hours, followed by water cooling / air cooling to eliminate component segregation and stabilize the microstructure, finally obtaining the as-cast Fe-Mn-Ge-RE sample.

[0016] The beneficial effects of this invention are as follows:

[0017] 1. This application successfully prepared a biodegradable rare earth iron-based medical material. The addition of rare earth elements effectively played the role of alloy strengthening and functionalization, and it is expected to become a potential biodegradable biomedical material.

[0018] 2. It has higher mechanical properties;

[0019] 3. The hemolysis rate meets the requirement of less than 5% for clinical medical materials, demonstrating good blood compatibility;

[0020] 4. It is non-cytotoxic and has good antibacterial effects;

[0021] 5. It has a faster degradation rate and can be degraded and excreted from the body more quickly after the wound heals. Attached Figure Description

[0022] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0023] Figure 1 This is a photograph of the as-cast Fe-30Mn-6Ge-0.6Gd sample according to a specific embodiment of the present invention.

[0024] Figure 2 XRD patterns of as-cast Fe-30Mn-6Ge and Fe-30Mn-6Ge-0.6Gd samples according to specific embodiments of the present invention;

[0025] Figure 3 The images show SEM images and EDS analysis results of the as-cast Fe-30Mn-6Ge-0.6Gd sample according to a specific embodiment of the present invention.

[0026] Figure 4The mechanical properties of as-cast Fe-30Mn-6Ge and Fe-30Mn-6Ge-0.6Gd specimens after tensile and compression tests are presented in the specific embodiments of the present invention.

[0027] Figure 5 The electrochemical performance parameters of the as-cast Fe-30Mn-6Ge and Fe-30Mn-6Ge-0.6Gd samples in Hanks' and FaSSIF solutions are fitted after polarization tests according to specific embodiments of the present invention.

[0028] Figure 6 The cell survival rate of L929 cells after culturing on the surface of cast Fe-30Mn-6Ge and Fe-30Mn-6Ge-0.6Gd samples for 3 days, as a specific embodiment of the present invention. Detailed Implementation

[0029] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0030] In the description of this application, it should be noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the exemplary embodiments according to this application. For ease of description, the dimensions of the various parts shown in the drawings are not drawn to actual scale. Techniques, methods, and devices known to those skilled in the art may not be discussed in detail, but where appropriate, such techniques, methods, and devices should be considered part of the specification. In all examples shown and discussed herein, any specific values ​​should be interpreted as merely exemplary and not as limitations. Therefore, other examples of exemplary embodiments may have different values. It should be noted that similar reference numerals and letters in the following drawings denote similar items; therefore, once an item is defined in one drawing, it need not be further discussed in subsequent drawings.

[0031] This invention provides a method for preparing a biodegradable rare-earth iron-based medical material for choledochoenterostomy devices. The biodegradable rare-earth iron-based medical material comprises the following components by mass percentage: Mn: 30-40%, Ge: 3-10%, RE: 0.02-1%, with the balance being Fe. The rare earth elements include one or more of the following sixteen non-radioactive rare earth elements: lanthanum (La), cerium (Ce), praseodymium (Pr), neodymium (Nd), europium (Eu), gadolinium (Gd), terbium (Tb), dysprosium (Dy), holmium (Ho), erbium (Er), thulium (Tm), ytterbium (Yb), and lutetium (Lu).

[0032] Example 1:

[0033] High-purity iron blocks (99.99%), micro-carbon manganese iron blocks (containing 20% ​​Fe, 0.05% C and the balance of Mn), single-crystal germanium particles (99.999%), and Gd rare earth rods (99.99%) were used as raw materials. They were mixed according to the burn-off rate and the mass percentage of Fe-30Mn-6Ge-0.6Gd. The mixture was placed in an alumina crucible and then placed in a vacuum induction melting furnace.

[0034] First, turn on the mechanical pump and molecular pump. After the vacuum degree in the vacuum induction melting furnace drops to 5×10-3 Pa, introduce 99.99% pure argon gas to raise the argon pressure to 50 kPa. Then, under argon protection, heat the alumina crucible containing the raw materials at 1250℃. After the molten steel is fully melted, continue heating for 10 minutes and then pour it into a 200mm×20mm×20mm high-purity graphite mold in the furnace. Finally, air cool to room temperature, release the pressure, and remove the Fe-30Mn-6Ge-0.6Gd alloy ingot.

[0035] Next, the ingot was placed in a muffle furnace heated to 850℃ for homogenization and annealing for 5 hours, followed by water cooling to eliminate compositional segregation and stabilize the microstructure. Finally, an as-cast Fe-30Mn-6Ge-0.6Gd sample was obtained. See the image below. Figure 1 As shown. Cast Fe-30Mn-6Ge samples were prepared using the same method for the control group.

[0036] X-ray fluorescence spectroscopy analysis revealed that the as-cast Fe-30Mn-6Ge-0.6Gd sample contained 29.83% Mn, 6.11% Ge, and 0.57% Gd, with the remainder being Fe. The as-cast Fe-30Mn-6Ge sample contained 30.26% Mn and 5.92% Ge, with the remainder being Fe.

[0037] Figure 2 The phase information of the as-cast Fe-30Mn-6Ge and Fe-30Mn-6Ge-0.6Gd samples obtained by X-ray diffraction shows that both samples are composed of non-magnetic γ-Fe (austenite) phase, which will not affect the nuclear magnetic resonance imaging detection after gastrointestinal anastomosis.

[0038] Figure 3The images show the SEM and EDS analysis results of the as-cast Fe-30Mn-6Ge-0.6Gd sample. As can be seen from the images, the gray raised (spot 1) and recessed (spot 2) phases contain abundant Fe, Mn, and Ge, and a small amount of Gd. The Mn and Ge atomic contents in spot 2 are smaller than those in spot 1, suggesting the presence of γ-Fe phases with varying Mn and Ge contents. Furthermore, the bright white phase with a size of 3.7 μm in spot 3 is likely a high-melting-point GdO2 phase, which could provide more heterogeneous nucleation sites for the alloy, thus refining the grain size.

[0039] Tensile specimens were prepared according to GB / T228.1-2010 "Metallic materials, tensile testing—Part 1: Tests at room temperature," and tensile tests were conducted at room temperature using a universal testing machine with a beam movement speed of 1 mm / min. Figure 4 As shown, the tensile yield strengths of the as-cast Fe-30Mn-6Ge and Fe-30Mn-6Ge-0.6Gd specimens were 286 MPa and 349 MPa, respectively; the tensile strengths were 695 MPa and 783 MPa, respectively; and the elongations were 54.5% and 62.8%, respectively. Cylindrical compression specimens were prepared according to GB / T7314-2017 "Metallic Materials - Compression Test at Room Temperature," and compression tests were conducted at room temperature using a universal testing machine with a beam movement speed of 0.5 mm / min. Figure 4 As shown, the compressive yield strengths of the as-cast Fe-30Mn-6Ge and Fe-30Mn-6Ge-0.6Gd specimens are 387 MPa and 493 MPa, respectively, and the compressive strains are both ≥70%.

[0040] The as-cast Fe-30Mn-6Ge and Fe-30Mn-6Ge-0.6Gd samples were tested at 37℃ in Hanks' simulated body fluid (8.0 g / L NaCl, 0.350 g / L NaHCO3, 0.4 g / L KCl, 0.023 g / L Na2HPO4, 0.060 g / L KH2PO4, 0.047 g / L MgCl2, 0.029 g / L MgSO4, 0. The electrochemical corrosion results in 14 g / L CaCl2, 1.0 g / L glucose (with the solution pH adjusted to 7.4 using 1 N NaOH or 1 N HCl) and in FaSSIF simulated intestinal fluid (0.42 g / L NaOH, 3.95 g / L NaH2PO4·H2O, 6.19 g / L NaCl, and 2.24 g FaSSIF powder completely dissolved, with the solution pH adjusted to 6.5 using 1 N NaOH or 1 N HCl) are shown in the figure. Figure 5 As shown.

[0041] The corrosion potentials of the as-cast Fe-30Mn-6Ge and Fe-30Mn-6Ge-0.6Gd samples in Hanks' solution were -0.623V and -0.637V, respectively; the corrosion currents were 39.2 A / cm² and 46.6 A / cm², respectively; and the corrosion rates were 460 μm / y and 547 μm / y, respectively. In contrast, the corrosion potentials in FaSSIF simulated intestinal fluid were -0.615V and -0.622V, respectively; the corrosion currents were 53.5 mA / cm² and 67.8 mA / cm², respectively; and the corrosion rates were 628 μm / y and 796 μm / y, respectively. The degradation rates of as-cast Fe-30Mn-6Ge and Fe-30Mn-6Ge-0.6Gd samples after immersion in Hanks' solution for 30 days were 73 μm / y and 86 μm / y, respectively, while the degradation rates in FaSSIF simulated intestinal fluid were 116 μm / y and 185 μm / y, respectively. Therefore, the Fe-30Mn-6Ge-0.6Gd sample exhibits a faster degradation rate in FaSSIF simulated intestinal fluid and can be degraded and excreted from the body more quickly after wound healing.

[0042] The hemolysis rates of the extracts from the cast Fe-30Mn-6Ge and Fe-30Mn-6Ge-0.6Gd samples in rat blood were 4.2% and 3.5%, respectively, meeting the requirement of less than 5% for clinical medical materials, demonstrating good blood compatibility. After culturing L929 cells directly on the surfaces of the cast Fe-30Mn-6Ge and Fe-30Mn-6Ge-0.6Gd samples for 3 days, the cell viability rates were 74.2% and 89.6%, respectively. According to ISO 10993-5 standard, the Fe-30Mn-6Ge-0.6Gd samples showed no cytotoxicity. Furthermore, the inhibition zone sizes of the cast Fe-30Mn-6Ge and Fe-30Mn-6Ge-0.6Gd samples after co-culturing with Escherichia coli for 1 day were 1.3 mm and 2.5 mm, respectively, both exhibiting good antibacterial effects. Therefore, Fe-30Mn-6Ge-0.6Gd exhibits higher mechanical properties, a degradation rate that better aligns with wound healing, and superior blood compatibility, cell compatibility, and antibacterial properties compared to Fe-30Mn-6Ge, indicating that the addition of rare earth element Gd plays a role in alloy strengthening and functionalization.

[0043] Example 2

[0044] High-purity iron blocks (99.99%), micro-carbon manganese iron blocks (containing 20% ​​Fe, 0.05% C and the balance of Mn), single-crystal germanium particles (99.999%), and Tb rare earth particles (99.99%) were used as raw materials. They were mixed according to the burn-off rate and in the mass percentage of Fe-30Mn-6Ge-0.1Tb. The mixture was placed in an alumina crucible and then placed in a vacuum induction melting furnace.

[0045] First, turn on the mechanical pump and molecular pump. After the vacuum degree in the vacuum induction melting furnace drops to 1×10-3 Pa, introduce 99.99% pure argon gas to raise the argon pressure to 40 kPa. Then, under argon protection, heat the alumina crucible containing the raw materials at 1300℃. After the molten steel is fully melted, continue heating for 10 minutes and then pour it into a 200mm×20mm×20mm high-purity graphite mold in the furnace. Finally, air-cool to room temperature, release the pressure, and remove the Fe-30Mn-6Ge-0.1Tb alloy ingot.

[0046] Next, the ingot was placed in a muffle furnace heated to 900℃ for homogenization and annealing for 10 hours, followed by water cooling to eliminate component segregation and stabilize the microstructure, finally obtaining the as-cast Fe-30Mn-6Ge-0.1Tb sample.

[0047] X-ray fluorescence spectroscopy analysis revealed that the as-cast Fe-30Mn-6Ge-0.1Tb sample contained 30.05% Mn, 6.03% Ge, and 0.58% Tb, with the remainder being Fe. The Fe-30Mn-6Ge-0.1Tb sample remains composed of non-magnetic γ-Fe (austenite) phase and will not affect magnetic resonance imaging (MRI) detection after gastrobiliary-intestinal anastomosis. The tensile yield strength, tensile strength, elongation, compressive yield strength, and compressive strain of the as-cast Fe-30Mn-6Ge-0.1Tb sample were 353 MPa, 809 MPa, 59.7%, 506 MPa, and ≥70%, respectively. The corrosion potentials of the as-cast Fe-30Mn-6Ge-0.1Tb sample in Hanks' simulated body fluid and FaSSIF simulated intestinal fluid were -0.632V and -0.618V, respectively; the corrosion currents were 59.2A / cm² and 70.4A / cm², respectively; and the corrosion rates were 695 μm / y and 826 μm / y, respectively. The degradation rates of the as-cast Fe-30Mn-6Ge-0.1Tb sample after immersion in Hanks' solution and FaSSIF simulated intestinal fluid for 30 days were 82 μm / y and 199 μm / y, respectively. The hemolysis rate of the as-cast Fe-30Mn-6Ge-0.1Tb sample extract in rat blood was 3.7%, meeting the requirement of less than 5% hemolysis rate for clinical medical materials, demonstrating good blood compatibility. L929 cells cultured directly on the surface of a cast Fe-30Mn-6Ge-0.1Tb sample for 3 days showed a cell viability of 87.9%, indicating no cytotoxicity according to ISO 10993-5 standards. Furthermore, the inhibition zone size of the cast Fe-30Mn-6Ge-0.1Tb sample after co-culturing with *E. coli* for 1 day was 2.9 mm, demonstrating good antibacterial effect. Therefore, compared to Fe-30Mn-6Ge, the Fe-30Mn-6Ge-0.1Tb sample also exhibits higher mechanical properties, a more favorable degradation rate for wound healing, and superior blood compatibility, cell compatibility, and antibacterial properties, indicating that the addition of rare earth element Tb also plays a role in alloy strengthening and functionalization.

[0048] Example 3

[0049] High-purity iron blocks (99.99%), micro-carbon manganese iron blocks (containing 20% ​​Fe, 0.05% C and the balance of Mn), single-crystal germanium particles (99.999%), and Dy rare earth particles (99.99%) were used as raw materials. They were mixed according to the burn-off rate and in the mass percentage of Fe-35Mn-5Ge-0.4Dy. The mixture was placed in an alumina crucible and then placed in a vacuum induction melting furnace.

[0050] First, turn on the mechanical pump and molecular pump. After the vacuum degree in the vacuum induction melting furnace drops to 3×10-3 Pa, introduce 99.99% pure argon gas to raise the argon pressure to 40 kPa. Then, under argon protection, heat the alumina crucible containing the raw materials at 1250℃. After the molten steel is fully melted, continue heating for 20 minutes and then pour it into a 200mm×20mm×20mm high-purity graphite mold in the furnace. Finally, air-cool to room temperature, release the pressure, and remove the Fe-35Mn-5Ge-0.4Dy alloy ingot.

[0051] Next, the ingot was placed in a muffle furnace heated to 850℃ for homogenization and annealing for 10 hours, followed by water cooling to eliminate component segregation and stabilize the microstructure, finally obtaining the as-cast Fe-35Mn-5Ge-0.4Dy sample.

[0052] X-ray fluorescence spectrometry analysis revealed that the as-cast Fe-35Mn-5Ge-0.4Dy sample contained 34.86% Mn, 4.97% Ge, and 0.38% Tb, with the remainder being Fe. The Fe-35Mn-5Ge-0.4Dy sample remained composed of non-magnetic γ-Fe (austenite) phase and would not affect magnetic resonance imaging (MRI) findings after gastrobiliary-intestinal anastomosis. The tensile yield strength, tensile strength, elongation, compressive yield strength, and compressive strain of the as-cast Fe-35Mn-5Ge-0.4Dy sample were 327 MPa, 734 MPa, 67.6%, 482 MPa, and ≥70%, respectively. The corrosion potentials of the as-cast Fe-35Mn-5Ge-0.4Dy sample in Hanks' simulated body fluid and FaSSIF simulated intestinal fluid were -0.659V and -0.634V, respectively; the corrosion currents were 62.8A / cm² and 74.0A / cm², respectively; and the corrosion rates were 737 μm / y and 869 μm / y, respectively. The degradation rates of the as-cast Fe-35Mn-5Ge-0.4Dy sample after immersion in Hanks' solution and FaSSIF simulated intestinal fluid for 30 days were 87 μm / y and 203 μm / y, respectively. The hemolysis rate of the as-cast Fe-35Mn-5Ge-0.4Dy sample extract in rat blood was 3.1%, meeting the requirement of less than 5% hemolysis rate for clinical medical materials, demonstrating good blood compatibility. L929 cells cultured directly on the surface of as-cast Fe-35Mn-5Ge-0.4Dy sample for 3 days showed a cell viability of 92.2%, indicating no cytotoxicity according to ISO 10993-5 standard. Furthermore, the inhibition zone size of the as-cast Fe-35Mn-5Ge-0.4Dy sample after co-culturing with *E. coli* for 1 day was 2.2 mm, demonstrating good antibacterial effect. Therefore, compared to Fe-30Mn-6Ge, the Fe-35Mn-5Ge-0.4Dy sample also exhibits higher mechanical properties, a more favorable degradation rate for wound healing, and superior blood compatibility, cell compatibility, and antibacterial properties, indicating that the addition of rare earth element Dy also plays a role in alloy strengthening and functionalization.

[0053] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A method for preparing a biodegradable rare-earth iron-based medical material for a choledochoenterostomy device, characterized in that, The biodegradable rare earth iron-based medical material comprises the following components by mass percentage: Mn: 30-40%, Ge: 3-10%, RE: 0.02-1%, with the balance being Fe; The RE is one or more of lanthanum, cerium, praseodymium, neodymium, europium, gadolinium, terbium, dysprosium, holmium, erbium, thulium, ytterbium, and lutetium; The biodegradable rare earth iron-based medical material is composed of the following raw materials: high-purity iron blocks with a purity of 99.99%, micro-carbon manganese iron blocks, single-crystal germanium particles with a purity of 99.999%, and rare earth rods, rare earth particles, or rare earth blocks with a purity of 99.99%. The preparation method comprises the following steps: a. Take high-purity iron blocks, micro-carbon manganese iron blocks, single-crystal germanium particles, and rare earth rods, rare earth particles, or rare earth blocks as raw materials. b. According to the burn-off rate and the Fe-Mn-Ge-RE mass percentage, mix them, put them into an alumina crucible and place them in a vacuum induction melting furnace; c. Turn on the mechanical pump and molecular pump in the vacuum arc melting furnace, and wait for the vacuum level in the vacuum induction melting furnace to drop to (1~10)×10. -3 After Pa, argon gas with a purity of 99.99% is introduced to raise the argon gas pressure to 10-100 kPa. Then, under the protection of argon gas, the alumina crucible containing the raw material is heated at 1250-1400℃ to melt it into molten steel. d. After the molten steel has been fully melted, continue heating for 5 to 30 minutes, and pour it into a 200mm×20mm×20mm high-purity graphite mold in the furnace. Finally, air cool it to room temperature, release the pressure and take out the Fe-Mn-Ge-RE alloy ingot. e. Next, the ingot is placed in a muffle furnace heated to 800-900℃ for homogenization annealing for 2-10 hours, followed by water cooling / air cooling to eliminate component segregation and stabilize the microstructure, finally obtaining the as-cast Fe-Mn-Ge-RE sample.

2. The method for preparing a biodegradable rare-earth iron-based medical material for a choledochoenterostomy device according to claim 1, characterized in that, The micro-carbon manganese iron block comprises the following components by mass percentage: Fe: 20%, 0.05% C, and the balance Mn.

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