Synchronous thyroid tumor biopsy and therapeutic biodegradable magnesium alloy implantation device

Abstract

The utility model belongs to the field of thyroid tumor biopsy and treatment, and particularly relates to a synchronous thyroid tumor biopsy and therapeutic biodegradable magnesium alloy implantation device which is suitable for non-open surgical treatment of biodegradable MgCu alloy implants. One end of a hollow biopsy needle of the device is inserted into one end of a transparent needle handle, and one end of a push rod is inserted into the other end of the transparent needle handle; the outer side of the other end of the transparent needle handle is provided with a Luer interface, and the other end of the transparent needle handle is matched and connected with a corresponding female Luer taper through the Luer interface; a magnesium alloy microneedle is arranged on the upper portion of a hollow inner cavity of the biopsy needle, the front end of the magnesium alloy microneedle is a tip end, a position blocking piece is arranged on the biopsy needle on the outer side of the magnesium alloy microneedle, the position blocking piece is elastic and corresponds to the magnesium alloy microneedle in shape, the front end of the position blocking piece extends into the biopsy needle, and the rear end of the magnesium alloy microneedle is a plane. And one end of the push rod extends into the hollow inner cavity of the biopsy needle and corresponds to the rear end of the magnesium alloy microneedle.

Description

Technical Field

[0001] The utility model belongs to the field of thyroid tumor biopsy and treatment, and particularly relates to a simultaneous thyroid tumor biopsy and therapeutic biodegradable magnesium alloy implantation device, which is applicable to the non-open surgery treatment of biodegradable MgCu alloy implants, and mainly aims at PTMC and thyroid tumor patients who cannot tolerate surgery or cannot be resected by surgical operation. Background Technique

[0002] Thyroid cancer is the most common malignant tumor in the endocrine system, and an increasing number of new cases have attracted great attention from all walks of life. The pathological types of thyroid cancer include differentiated thyroid cancer (DTC), anaplastic or undifferentiated thyroid cancer (ATC), and medullary thyroid cancer (MTC). Among them, differentiated thyroid cancer includes papillary thyroid carcinoma (PTC), follicular thyroid carcinoma (FTC), and poorly differentiated thyroid cancer (PDTC). Among these five pathological types, PTC is the most common, accounting for about 85-90% of thyroid malignancies. Papillary thyroid microcarcinoma (PTMC) refers to papillary thyroid carcinoma with a diameter of 1.0 cm, and has a very good prognosis, with an overall mortality rate lower than

[0003] ≤1% [doi:10.3390 / cancers12051345]. In recent years, due to the development of imaging technology, the number of PTMCs incidentally discovered in the past has increased rapidly. Regarding this relatively indolent and stable cancer, some experts believe that there is overdiagnosis and even overtreatment [doi:10.1007 / s00268-022-06770-z]. The American Thyroid Association (ATA) guidelines recommend that for patients with PTMC without obvious metastasis or local spread, as well as those with a short remaining life expectancy and a high surgical risk, active surveillance can be considered. However, clinically, some patients undergoing long-term active surveillance still experience local invasion or lymph node metastasis. In addition, once diagnosed with PTMC, some patients have varying degrees of anxiety and uneasiness about the tumor-bearing state, and thus are willing to accept relatively aggressive interventions rather than active surveillance, resulting in patients undergoing excessive intensive treatment. Moreover, surgery causes greater trauma to patients and is prone to postoperative complications such as parathyroid injury and hypothyroidism.

[0004] As an emerging minimally invasive treatment method, thermal ablation technology has shown broad application prospects in the treatment of thyroid cancer. This technology has the advantages of convenient operation, fewer complications, and preservation of thyroid function. It has been widely used especially in the treatment of recurrent thyroid cancer and papillary thyroid microcarcinoma, and is recommended by multiple domestic and foreign guidelines. The treatment cost is approximately 10,000 - 15,000 yuan. Thermal ablation technology includes various forms such as laser ablation, radiofrequency ablation, and microwave ablation, all of which aim to damage the target tissue by heating the local tissue to 60°C and above. Although the value of thermal ablation technology in the treatment of benign thyroid nodules has been affirmed by multiple domestic and foreign guidelines, its application in the treatment of thyroid cancer is still a highly controversial topic at present, mainly focusing on the following three aspects: (1) The safety margin of thermal ablation: Different from other organs such as the liver and kidney, the thyroid gland is small in volume and adjacent to important structures such as the trachea, blood vessels, and nerves. How to completely inactivate the tumor while ensuring that the surrounding important structures are not thermally damaged is a challenge faced by the application of thermal ablation in the treatment of thyroid cancer; (2) The management of regional lymph nodes: Thyroid cancer is prone to lymph node metastasis in the early stage, especially in the central region, which is the most common. However, the sensitivity of preoperative ultrasound and CT in identifying metastatic lymph nodes in the central region is limited, easily leading to the omission of positive lymph nodes; (3) Thermal ablation increases the difficulty of reoperation. After thermal ablation, local tissue degeneration and necrosis will occur, and over time, it will manifest as edema, adhesion, and fibrosis, increasing the difficulty of surgical operation and affecting the safety and thoroughness of the operation.

[0005] In recent years, metallic magnesium (Mg) has shown great application potential in the field of medical devices due to its special biodegradability, good mechanical properties, and excellent biocompatibility (PMID: 30965229). Some studies have shown that an increase in the content of Mg ions in serum can reduce the incidence risks of colon cancer and primary liver cancer (PMID: 31167754, PMID: 32105342). Tumor formation experiments on nude mice have shown that Mg ion injection can inhibit the growth of colon cancer cells (PMID: 36006540). Magnesium degradation also leads to an increase in OH - which results in an alkaline environment, and this alkaline environment is also a key factor in inhibiting the growth of tumor cells (PMID: 35386318). In addition, studies have shown that magnesium-copper alloys (such as Mg0.2Cu with 0.2 wt% Cu content and the rest being Mg) continuously release magnesium ions and copper ions simultaneously in a physiological environment, and their dissolution rate is within the range that the body can tolerate, so it will not affect biological safety. The release of Cu ions in such an alkaline environment will have a dual antibacterial effect combining alkaline antibacterial and copper ion antibacterial on bacteria such as Staphylococcus aureus (PMID: 27271057), see a biodegradable magnesium alloy with strong antibacterial function (Publication No. CN104645422A).

[0006] Currently, the relevant patents on magnesium-based alloys for anti-tumor are as follows:

[0007] (1) Publication No.: CN115612902A. Jia Qing'an et al. prepared a magnesium-based alloy micron particle that synergistically acts with TACE against liver cancer. It uses metallic magnesium as a carrier and prepares magnesium-based alloy micron particles together with other metal particles with anti-cancer effects. It is locally implanted into the tumor tissue before TACE treatment. In the initial stage, it reverses the negative effects of TACE through various methods such as alkalinized microenvironment and antioxidant caused by degradation. At the end stage, after degrading to the nano-scale particle size, it is endocytosed by cells and directly exerts anti-cancer effects inside the cells. This provides a new anti-tumor implant material with the ability to reverse the negative effects of TACE and enhance the anti-liver cancer efficacy of TACE, enabling clinical malignant tumor patients to benefit in terms of survival.

[0008] (2) Publication No.: CN116254445A. Wang Leyun et al. developed a preparation method of a Mg-Al-Ca ternary magnesium alloy and its use as an anti-tumor implant material or a medium for magnetic hyperthermia. By magnetically heating the Mg-Al-Ca alloy wire and combining its relatively fast degradation rate, it can inhibit the growth of large-diameter tumors, and its tumor inhibition effect is significantly better than that of pure magnesium. Currently, there is no relevant research and clinical plan on the treatment of thyroid cancer with biodegradable magnesium alloy implants. Utility Model Content

[0009] The purpose of the present utility model is to provide a synchronous thyroid tumor biopsy and therapeutic biodegradable magnesium alloy implantation device, which can take thyroid tissue samples by fine needle puncture under ultrasonic guidance, implant a biodegradable MgCu alloy into the lesion site, and has antibacterial properties at the same time.

[0010] The technical solution of the present utility model:

[0011] A synchronous thyroid tumor biopsy and therapeutic biodegradable magnesium alloy implantation device, which includes a biopsy needle, a blocking piece, a magnesium alloy micro-needle, a transparent needle handle, a Luer interface, and a push rod. The specific structure is as follows:

[0012] One end of the hollow biopsy needle is inserted into one end of the transparent needle handle, and one end of the push rod is inserted into the other end of the transparent needle handle; a Luer interface is arranged on the outer side of the other end of the transparent needle handle and is connected in a matching manner with a corresponding female Luer connector through the Luer interface; a magnesium alloy micro-needle is arranged in the upper part of the hollow inner cavity of the biopsy needle. The front end of the magnesium alloy micro-needle is a tip, and a blocking piece is arranged on the biopsy needle outside the magnesium alloy micro-needle. The blocking piece has elasticity and corresponds to the shape of the magnesium alloy micro-needle. The front end of the blocking piece extends into the biopsy needle. The rear end of the magnesium alloy micro-needle is a plane, and one end of the push rod extends into the hollow inner cavity of the biopsy needle and corresponds to the rear end of the magnesium alloy micro-needle.

[0013] For the synchronous thyroid tumor biopsy and therapeutic biodegradable magnesium alloy implantation device described above, the size of the magnesium alloy micro-needle is: diameter Φ = 0.2 mm to 0.8 mm, and length 3 mm to 6 mm.

[0014] For the synchronous thyroid tumor biopsy and therapeutic biodegradable magnesium alloy implantation device described above, the magnesium alloy micro-needle adopts a magnesium copper alloy micro-needle.

[0015] For the synchronous thyroid tumor biopsy and therapeutic biodegradable magnesium alloy implantation device described above, scale marks are provided on the side of the biopsy needle.

[0016] The design concept of the present utility model is:

[0017] At present, the only method for thyroid cancer is puncture biopsy, and the biopsy and therapeutic device for thyroid tumors of the present utility model is the first of its kind. Fine needle aspiration biopsy under ultrasound guidance has become the main method for preoperative diagnosis of thyroid cancer, which has the characteristics of low cost and convenient operation, and can also provide real-time guidance for the biopsy area. The traditional surgical method for thyroid cancer is unilateral / bilateral thyroidectomy + central compartment lymph node dissection + therapeutic lateral cervical lymph node dissection, which can reduce the postoperative recurrence and metastasis rate of patients. However, it is also easy to cause parathyroid gland injury, and patients need to take thyroid hormone for life after surgery, and there are scars left on the neck of the surgical incision, which is not conducive to the improvement of the quality of life of patients after prognosis. Therefore, the present utility model develops a biopsy and therapeutic biodegradable magnesium alloy implantable microneedle for thyroid tumors, which implants magnesium copper alloy into the lesion site while taking thyroid tissue samples for biopsy of the thyroid gland. This implant has good biocompatibility and degradability, and can gradually degrade in the body to play an anti-cancer role, avoiding the risks and discomforts of secondary surgery, and reducing the recovery time and cost of patients [doi:10.1016 / J.JMA.2023.02.007]. At the same time, the magnesium copper alloy has antibacterial properties, which can reduce the inflammatory reaction caused by invasive operations. This non-open surgical treatment strategy is mainly aimed at PTMC, or patients with thyroid tumors who cannot tolerate surgery or cannot be resected surgically. However, surgical treatment is still recommended for high-risk PTMC, and it can be used as an alternative for patients such as low-risk PTMC.

[0018] The advantages and beneficial effects of the present utility model are as follows:

[0019] 1. Advantages in treatment:

[0020] Surgery + radioactive 131 I treatment + thyroid hormone suppression therapy are common treatment methods for thyroid cancer. These treatment methods can effectively control the condition and improve the prognosis of patients. However, hypothyroidism after surgery is a common problem, and patients need to take thyroid hormone replacement therapy for life, which will cause great damage to the patient's body. In addition, iodine ( 131 I) treatment will affect the salivary gland function of patients, resulting in dry mouth; some patients may also have complications such as neck lymphedema, hoarseness (if the recurrent laryngeal nerve is damaged during surgery) or hypoparathyroidism; at the same time, surgery cannot solve the problems of patients' surgical intolerance, etc. (PMID:34871424). Thermal ablation technology is commonly used in clinical practice to treat benign thyroid nodules, but its application in the treatment of thyroid cancer is still a highly controversial topic at present, and it will cause a series of adverse reactions, including local pain, bleeding, recurrent laryngeal nerve injury, tumor recurrence, etc.

[0021] 2. Advantages in operation:

[0022] For the combined treatment of synchronous thyroid lesion puncture biopsy and magnesium-copper alloy implantation, the best puncture plane can be selected according to the patient's ultrasound image, taking care to avoid arterial blood vessels, and determining the needle insertion direction and angle. Local anesthesia is used, and the needle is inserted in segments. After inserting the needle, an appropriate depth is selected, and ultrasound is used to assist in confirming whether the needle insertion direction, angle, and depth are appropriate. When the biopsy needle tip penetrates into the tumor lesion, the guiding needle (pushing rod) implants the therapeutic magnesium-copper alloy into the lesion. Further, a biopsy is taken around the implanted material, and the lesion tissue obtained by the biopsy is immersed in formaldehyde solution for specimen fixation. After fixation, pathological examination is performed. Brief Description of the Drawings

[0023] Figures 1 - 2 It is a schematic structural diagram of a synchronous thyroid tumor biopsy and therapeutic biodegradable magnesium alloy implantation device. Among them, Figure 1 is the front view, Figure 2 is Figure 1 the enlarged view at position A in

[0024] In the figure: 1 - biopsy needle, 2 - blocking piece, 3 - magnesium alloy micro-needle, 4 - scale mark, 5 - transparent needle handle, 6 - Luer connector, 7 - pushing rod.

[0025] Figure 3 It is the effect of MTT method to detect the inhibitory rate of Ti, Mg, and Mg0.2Cu alloy extracts on the proliferation of thyroid cancer cells. (a) Human papillary thyroid cancer cell line TPC1, (b) Human thyroid cancer cell line BHT-101, (c) Human normal thyroid cell line NTHY-ORI 3-1. The abscissa Time is time (h), and the ordinate OD Value is optical density.

[0026] Figure 4 It is the change diagram of the pH value (a) and corrosion rate (b) of Mg and Mg0.2Cu metal materials immersed in the simulated solution for different times. pH value is the pH value, and Corrosion Rate is the corrosion rate (mm / y). Detailed Embodiment

[0027] As Figures 1 - 2 shown, the present utility model provides a synchronous thyroid tumor biopsy and therapeutic biodegradable magnesium alloy implantation device, which mainly includes a biopsy needle 1, a blocking piece 2, a magnesium alloy micro-needle 3, a scale mark 4, a transparent needle handle 5, a Luer connector 6, and a pushing rod 7. The specific structure is as follows:

[0028] One end of the hollow biopsy needle 1 is inserted into one end of the transparent needle handle 5, and one end of the push rod 7 is inserted into the other end of the transparent needle handle 5; a Luer connector 6 is arranged on the outer side of the other end of the transparent needle handle 5 and is connected with a corresponding female Luer connector in a matching manner; a magnesium alloy microneedle 3 is arranged in the upper part of the hollow inner cavity of the biopsy needle 1, the front end of the magnesium alloy microneedle 3 is a tip, a blocking piece 2 is arranged on the biopsy needle 1 outside the magnesium alloy microneedle 3, the blocking piece 2 is elastic and corresponds to the shape of the magnesium alloy microneedle 3, the front end of the blocking piece 2 extends into the biopsy needle 1, the rear end of the magnesium alloy microneedle 3 is a plane, one end of the push rod 7 extends into the hollow inner cavity of the biopsy needle 1 and corresponds to the rear end of the magnesium alloy microneedle 3, and a scale mark 4 is arranged on the side surface of the biopsy needle 1. The size of the magnesium alloy microneedle 3 is: diameter Φ = 0.2 mm to 0.8 mm, and length 3 mm to 6 mm.

[0029] In the utility model, the magnesium alloy microneedle 3 is directly arranged in the biopsy needle 1, and while biopsy sampling is completed, the magnesium alloy microneedle 3 is implanted into the lesion. That is, under the guidance of ultrasound, the tumor therapeutic magnesium alloy microneedle 3 in the biopsy needle 1 is implanted into the lesion through the push rod 7, and at the same time, the biopsy needle 1 takes a thyroid tissue sample around the implanted material. The utility model performs interventional treatment and tissue biopsy simultaneously, avoiding the damage brought to the patient by repeated punctures. Fundamentally, for patients who need simultaneous puncture biopsy of the target lesion and interventional treatment, the problems such as the intolerance of traditional surgery and thermal ablation are solved, and at the same time, the puncture-related complications such as tissue damage and bleeding that occur in the patient after surgery due to the need for multiple puncture withdrawals are solved, greatly reducing the complication rate.

[0030] In the utility model, a scale mark 4 is arranged on the biopsy needle 1, which is convenient for calculating the inserted depth during puncture, making the measurement more convenient and fast and improving the operation efficiency. The transparent needle handle 5 can facilitate the observation of the puncture and pushing processes, and the Luer connector 6 can facilitate the connection of the matching female Luer connector part. During use, ① under the guidance of ultrasound, the needle is inserted layer by layer along the predetermined puncture path into the patient's thyroid tissue until it reaches the lesion; ② according to the magnesium alloy microneedle 3 customized according to the size of the lesion before surgery, the magnesium alloy microneedle 3 is implanted into the lesion, and sampling is performed around the implanted magnesium alloy microneedle 3, and after sampling is completed, the biopsy needle 1 is withdrawn; ③ the biopsy needle 1 is withdrawn, and the wound is disinfected and bandaged, and the operation is completed.

[0031] Magnesium is one of the light elements with rich reserves on the earth, and the material cost is extremely low. Magnesium is an essential nutrient element in the human body and is involved in almost all life activities of the human body. The degraded magnesium ions will not bring toxicity, and after surgery, the magnesium implant will gradually degrade in the human body and there will be no large amount of foreign bodies remaining in the body. During the degradation process, OH is continuously generated -, Hydrogen and magnesium ions have an inhibitory effect on tumors. The experimental research carried out for this utility model has also confirmed its remarkable tumor-killing effect, and the biological safety has been verified by using a variety of experimental animals (nude mice, rabbits). At the same time, the absorption spectrum presented by magnesium-based metals under X-rays is obvious, and even under magnetic resonance imaging, it will not cause interference to surrounding tissues, which is conducive to postoperative diagnosis and imaging observation.

[0032] Magnesium can have a good inhibitory effect on the survival of bacteria due to the locally alkaline environment generated by its degradation, can inhibit the formation of biofilms, and reduce the risk of infection. The magnesium alloy microneedles 3 can be made of magnesium-copper alloy (Mg0.2Cu), and after adding Cu with antibacterial effect, the antibacterial performance is more excellent.

[0033] The means of using magnesium alloy microneedles to treat thyroid cancer during thyroid tumor biopsy proposed by this utility model is a brand-new thyroid treatment technology. While taking a biopsy from the patient, biodegradable microneedles are implanted for interventional treatment, which plays a therapeutic role in thyroid cancer. The biopsy and interventional treatment are carried out simultaneously, avoiding the complications caused by repeated punctures, and can make up for or replace traditional surgery and thermal ablation techniques, and the specific manifestations are as follows:

[0034] I. In terms of materials:

[0035] 1. Low cost:

[0036] China is the country with the richest magnesium resources in the world, and the main production areas include Shanxi, Liaoning, Ningxia, Shaanxi, Henan and other provinces. Fugu County in Yulin City, Shaanxi Province is one of the main production areas of metallic magnesium in China and has rich magnesium ore resources. In 2023, China's primary magnesium output was 822,400 tons, accounting for 82.24% of the global total output. These rich resources have laid a solid foundation for the development of the magnesium metal industry. In 2023, the price of magnesium ingots in China generally showed a downward trend and fluctuated at a relatively low level. The price of magnesium ingots at the beginning of the year was 21,600 yuan / ton, and by the end of the year, the price dropped to 20,200 yuan / ton, showing an obvious downward trend. During this year, the magnesium price had a short-term rebound, but generally it was still in the downward channel. The rich storage and low price of magnesium raw materials have laid a material foundation for its wide application.

[0037] 2. Antitumor effect:

[0038] The present utility model is a pioneering new technology for tumor treatment. At the cellular level, it has been confirmed by CCK-8 assay that the extracts of pure magnesium and magnesium-copper alloy have an inhibitory effect on the growth of thyroid cancer cells TPC-1 and BHT-101, but have no significant cytotoxic effect on the normal human thyroid cell line NTHY-ORI 3-1. The extracts of pure magnesium and magnesium-copper alloy showed significant inhibition of tumor cell growth in the two thyroid cancer cell lines at 6 h, and the inhibitory effect on tumor cells became more obvious with the prolongation of time. In the cell live / dead staining experiment, after co-culturing with tumor cells for 12 h and 24 h respectively, different degrees of cell death could be observed in the groups of pure magnesium and magnesium-copper alloy extracts, and the number of dead cells increased with the prolongation of the culture time. The results of the colony formation assay showed that the extracts of pure magnesium and magnesium-copper alloy could inhibit the colony formation ability of thyroid cancer cells. The results of the scratch assay and Transwell assay showed that the extracts of pure magnesium and magnesium-copper alloy could significantly reduce the number of transmembrane invasive and migratory cells and the relative migration rate of cells. The results of scanning electron microscopy observation showed that the extracts of pure magnesium and magnesium-copper alloy could inhibit the formation of pseudopodia of thyroid cancer cells. The results of fluorescence confocal microscopy observation on the effects of cell morphology and cytoskeletal proteins F-actin and α-tubulin showed that the extracts of pure magnesium and magnesium alloy could affect the rearrangement of F-actin in cells, but there was no significant change in the effect on α-tubulin protein. The results of flow cytometry Annexin V-FITC / PI double staining assay showed that after co-culturing with tumor cells for 24 h, compared with the control group, the apoptosis rate (early and late) of the pure magnesium and magnesium-copper alloy groups was significantly increased, improving the apoptosis rate of thyroid cancer cells and inducing apoptosis.

[0039] At the animal level, a subcutaneous xenograft tumor model of thyroid cancer cells in nude mice was constructed. The experiment was divided into 3 groups, namely the pure titanium group, the pure magnesium group, and the magnesium-copper alloy group, with 6 mice in each group. Logarithmic growth phase thyroid cancer cells of each group were injected subcutaneously into nude mice, and tumors could form in the axilla of one side of the nude mice. When the tumor volume reached 50 mm 3At that time, pure titanium, pure magnesium, and magnesium-copper alloy filaments of the same specification were respectively implanted into the tumors for 2 weeks. Micro-CT examinations were performed on each group of nude mice, and the tumor masses were dissected and weighed. The results showed that significant ablation occurred in the tumor masses of the pure magnesium group and the magnesium-copper alloy group, and the volume of the tumor masses significantly decreased, while there was no effect in the pure titanium group. The biosafety of the materials was detected at the animal level (nude mice, rabbits). That is, liver, spleen, and kidney tissues were respectively taken from the nude mice in the pure titanium group, pure magnesium group, and magnesium-copper alloy group, and HE staining sections were made. The results showed that there were no obvious differences in the HE staining of the three groups, indicating that the magnesium-based metals had no obvious toxicity to animal tissues. After implanting these materials into the unilateral thyroid of female New Zealand white rabbits for 14 days, the thyroid function and morphological changes of the rabbits were detected. The results showed that there were no obvious differences in the morphology, size, and color Doppler imaging comparison of the thyroid glands on the operative side and the control side of the three groups of rabbits. However, the free thyroxine (FT3) and free triiodothyronine (FT4) in the bodies of the rabbits in the pure magnesium group and the magnesium-copper alloy group were significantly decreased, indicating that the implantation of magnesium-based metals for 14 days would significantly affect the changes in the thyroid function of the body. However, the morphology and size of the thyroid follicles and epithelial cells on the operative side and the contralateral side of the three groups of rabbits were normal, and there were no obvious lymphocyte infiltration and interstitial fibrosis. The above results suggest that the direct effect of magnesium-based metals on the thyroid may be mainly manifested as functional changes, rather than obvious histological changes. This functional change may be due to the local microenvironment changes caused by the implantation of magnesium-based metals, such as pH changes, ion release, etc., thus affecting the synthesis and release of thyroid hormones.

[0040] 3. Good mechanical properties:

[0041] The mechanical properties of the magnesium-based metals were detected by a universal testing machine. The results showed that obvious degradation occurred in the magnesium-ketone alloy in simulated body fluid, and the degradation rate had no significant difference from that of pure magnesium; as shown in Table 1, with the addition of copper content in the alloy, the tensile strength (Rm) of the as-cast magnesium-ketone alloy increased from (87 ± 5) MPa without copper addition to (220 ± 10) MPa, and the elongation at break (%) increased from 11.05% to 15.15%. It is suggested that the Mg0.2Cu alloy has more excellent strength and plasticity as a puncture implant material, which is beneficial to clinical application and lays a material foundation for the interventional treatment of thyroid tumors.

[0042] Table 1 shows the comparison of the maximum force, tensile strength, and yield strength of Mg and Mg0.2Cu metal materials

[0043]

[0044] II. Antibacterial effect:

[0045] In terms of antibacterial effect, the previous patent technology "A biodegradable magnesium alloy with strong antibacterial function (publication number CN104645422A)" has proved that magnesium-copper alloy (Mg0.2Cu) has a dual antibacterial effect on Escherichia coli and Staphylococcus aureus, combining alkaline antibacterial and copper ion antibacterial effects, showing excellent anti-bacterial infection function.

[0046] 3. Equipment: Easy to operate

[0047] The utility model of the simultaneous thyroid biopsy combined with biodegradable magnesium alloy anti-tumor microneedle implantation treatment device can simultaneously complete biopsy sampling and anti-tumor microneedle implantation treatment by directly setting the magnesium alloy microneedle in the biopsy needle. During the puncture biopsy process, the anti-tumor material is implanted into the target lesion through the push rod, which not only simplifies the operation process, but also avoids the damage caused to the patient by multiple punctures. The device fundamentally provides convenience for patients who need to perform target lesion puncture biopsy and thyroid treatment at the same time, and provides a new treatment method for patients who are not suitable for traditional surgery and thermal ablation.

[0048] The results of the study on the anti-thyroid cancer activity of biodegradable magnesium-based metals show that Mg-based alloy implant materials exhibit excellent performance in many aspects. First, the material significantly inhibits the proliferation of thyroid cancer cells, and cell proliferation-related experiments show that it has a highly effective anti-tumor growth effect. Secondly, the alloy material can significantly reduce the risk of tumor spread by inhibiting the invasion and metastasis of cancer cells, and this effect has been quantified in the invasion and metastasis experiment. In addition, the material can effectively induce apoptosis of tumor cells by promoting the apoptosis pathway, which is proved by flow cytometry experiments, further confirming its ability to inhibit the malignant biological behavior of tumors. At the same time, Mg-based alloy implant materials show low systemic toxicity in vivo, and the results of organ histological examinations show that it has minimal damage to normal tissues. Finally, the antibacterial activity and excellent mechanical properties of the material have also been confirmed. In summary, biodegradable magnesium-based metals show comprehensive technical advantages in the treatment of anti-thyroid cancer, providing a strong scientific basis for clinical application.

[0049] like Figure 3 As shown in the figure, the MTT method was used to detect the effects of Ti, Mg, and Mg0.2Cu alloy extracts on the proliferation inhibition rate of thyroid cancer cells. It can be seen that compared with the control group Ti group, Mg and Mg0.2Cu alloy extracts treated thyroid cancer cells TPC-1 and BHT-101 for 6 hours inhibited cell proliferation in a time-dependent manner, but had no significant cytotoxic effect on the normal human thyroid cell line NTHY-ORI 3-1.

[0050] like Figure 4As shown in the corrosion rate diagrams of Mg and Mg0.2Cu metal materials immersed in the simulated solution for different times, there is no significant difference in the in vitro corrosion rates of Mg and Mg0.2Cu metal materials.

[0051] The implementation results show that the synchronous thyroid tumor biopsy and therapeutic biodegradable magnesium alloy implantation device of the present utility model has application value in the diagnosis and treatment of thyroid cancer, and is expected to provide a mild, safe and effective alternative treatment method for thyroid cancer.

[0052] The protection scope of the present utility model is not limited thereto. Any person skilled in the art within the technical scope disclosed by the present utility model, according to the technical solution and concept of the present utility model, making equivalent substitutions or changes should be covered within the protection scope of the present utility model.

Claims

1. A biodegradable magnesium alloy implant device for simultaneous thyroid tumor biopsy and treatment, characterized in that: The device includes a biopsy needle, a blocking piece, a magnesium alloy microneedle, a transparent needle handle, a Luer interface, and a push rod. The specific structure is as follows: One end of the hollow biopsy needle is inserted into one end of the transparent needle handle, and one end of the push rod is inserted into the other end of the transparent needle handle; a Luer interface is arranged on the outer side of the other end of the transparent needle handle, and is matched and connected with a corresponding female Luer connector through the Luer interface; a magnesium alloy microneedle is arranged on the upper part of the hollow inner cavity of the biopsy needle, the front end of the magnesium alloy microneedle is a pointed end, and a blocking piece is arranged on the outer side of the magnesium alloy microneedle on the biopsy needle, the blocking piece is elastic and corresponds to the shape of the magnesium alloy microneedle, the front end of the blocking piece extends into the biopsy needle, the rear end of the magnesium alloy microneedle is a plane, and one end of the push rod extends into the hollow inner cavity of the biopsy needle and corresponds to the rear end of the magnesium alloy microneedle.

2. The simultaneous thyroid tumor biopsy and therapeutic biodegradable magnesium alloy implant device according to claim 1, characterized in that: The size of the magnesium alloy microneedle is: diameter Φ=0.2mm~0.8mm, length 3mm~6mm.

3. The simultaneous thyroid tumor biopsy and therapeutic biodegradable magnesium alloy implant device according to claim 1 or 2, characterized in that: Magnesium alloy microneedles use magnesium-copper alloy microneedles.

4. The simultaneous thyroid tumor biopsy and therapeutic biodegradable magnesium alloy implant device according to claim 1, characterized in that: There are graduation markings on the side of the biopsy needle.

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