Tantalum metal material additive manufacturing intervertebral fusion device technology advantages:

1. As a "biophilic" metal, tantalum has good corrosion resistance [1] and biocompatibility [2-3], its affinity to bone tissue is outstanding, bone conduction and bone induction ability is excellent, and it promotes bone growth and bone fusion;

2. Three-dimensional penetrating bionic trabecular microporous structure is beneficial to bone fusion and vascularization. The porosity is as high as 68%-78%, which promotes bone ingrowth and blood vessel formation and improves the fusion rate;

3, the elastic modulus is close to the human cancellous bone and trabecula, the biomechanical adaptation is high, and the stress shielding is reduced;

4. High matching degree of anatomical morphology, micron and nanometer surface roughness, and high friction coefficient with human bones [4], which is conducive to improving the fusion rate and stability, and has outstanding anti-sinking ability;

5, excellent load-bearing capacity [5], can achieve immediate load; high toughness and high plasticity, excellent fatigue resistance;

Expand reading

Tantalum is known as the "biophilic" metal. As early as 1802, Swedish chemists Ekeberg discovered tantalum in the ore and named it Tantalus.

In 1866, Rhodes used sodium reduction Na2TaF7 method to obtain high purity tantalum. Pure tantalum is a gray, shiny, hard metal.

Tantalum has moderate hardness and good ductility, and can be drawn into tantalum wire that is thinner than hair; tantalum has extremely stable chemical properties and strong corrosion resistance. In addition to hydrofluoric acid, sulfur trioxide, hot concentrated sulfuric acid and alkali, It can resist all inorganic and organic acid corrosion. Tantalum thermal expansion coefficient is very small, such as 1903 German chemist Bolton made of metal tantalum filament material.

Due to its unique physical and chemical properties, tantalum is widely used in the chemical, capacitor, electronics and aerospace industries. Tantalum has excellent bioinertness and biocompatibility. Pure tantalum was first used in orthopedics in 1940, and has been used in clinical practice for nearly 80 years, including skull patch, cardiac pacemaker, bone and joint prosthesis and suture.

Porous tantalum morphology components can be prepared by using pure tantalum materials, and clinical practice shows that porous tantalum can reduce stress shielding while providing sufficient mechanical strength, which is conducive to bone biomechanical conduction and shaping after bone regeneration; porous tantalum has good biocompatibility and induces bone tissue and vascular tissue to grow into porous tantalum. The above characteristics make porous tantalum materials widely used in the repair of femoral head necrosis, joint replacement, bone defect repair and other orthopedic fields. Therefore, porous tantalum is considered to be the most ideal orthopedic implant material.

In the past 50 years, the manufacture of metal tantalum parts is mostly the first use of powder metallurgy or electron beam melting method to obtain the ingot of tantalum metal, and then after plastic deformation, welding and heat treatment to obtain the final product.

Tantalum metal has excellent properties such as stable chemical properties, abrasion resistance and good biocompatibility, which is an ideal metal material for bone implant devices. However, due to the high density (16.6g/cm3) and elastic modulus (185.7 GPa) of pure tantalum, the direct processing of bone implant materials for the medical field has been limited in clinical application.

Until a company in the United States used chemical vapor deposition method to prepare commercial medical porous trabecular tantalum metal products, which solved the two problems of high density and high elastic modulus, and showed excellent biomechanical compatibility and osseointegration in clinical applications, porous tantalum was considered to be the most potential alternative to traditional metal implants of new bone implant materials.

At present, the use of chemical vapor deposition on the market to prepare porous tantalum metal implants such as tantalum metal joint pads, porous tantalum metal spinal fusion device and other products are almost monopolized by a giant company in the United States, the price is high, "high-end and expensive".

On the other hand, the chemical vapor deposition process is complex, the production cost is high, the preparation of personalized porous tantalum implants with complex morphology and anatomical matching is difficult, and the precise control and "large-scale customized production" of highly bionic porous structures cannot be achieved ".

This obviously cannot meet the urgent needs of industrial upgrading in the medical market and personalized medicine for metal tantalum complex components such as porous tantalum implants.

In recent years, digital-driven advanced manufacturing processes have ushered in a period of rapid development. Powder bed melting additive manufacturing equipment and processes represented by selective laser melting (SLM) technology and electron beam selective melting (EBM) have matured continuously. Titanium alloy parts produced by them have been applied on a large scale in medical, aviation, aerospace and other fields. This provides a new process for the manufacture and production of porous tantalum.

The advancement of additive manufacturing metal 3D printing technology has brought hope to break through this technical problem.

Compared with the traditional processing technology, additive manufacturing technology has obvious advantages in the processing of porous tantalum, such as: high material utilization rate, using the three-dimensional digital model of the component as the template to make the size of the blank close to the final product, reducing the processing allowance, reducing the production cost, simplifying and shortening the processing process, improving the production efficiency, and realizing personalized customization. Therefore, the use of additive manufacturing technology to prepare porous tantalum components, to achieve the high-quality shape and internal details of tantalum complex components, to meet the industrial upgrading and personalized diagnosis and treatment services, has important scientific value and application value.

China is the most populous country in the world. It is of great social significance to carry out research on the preparation of bone implant materials in China. It can not only break foreign technical barriers, reduce domestic dependence on such imported products, meet the urgent needs of Chinese people, but also is expected to realize the substitution of imported products. The market prospect is broad.

Hunan Huaxiang Medical Technology Co., Ltd. is committed to the application research and development of new biomaterials, 3D printing medical treatment and other fields. It has cooperated with many medical institutions and scientific research institutes at home and abroad to form an innovative development model of "production, education, research and medicine". It has accumulated rich industry experience in the fields of 3D printing medical treatment, porous tantalum metal, degradable zinc alloy and so on.

The approval of Huaxiang Medical's first tantalum metal additive manufacturing intervertebral fusion device medical device registration certificate marks a breakthrough in the industrialization of porous tantalum metal implanted medical devices, filling the market gap in the field of porous tantalum material additive manufacturing, which fully reflects Huaxiang Medical's scientific research and innovation ability in the field of innovative medical devices.

This is an important technological breakthrough in China's medical field, a milestone event in the field of tantalum metal additive manufacturing, and will lead the rapid development and progress of the industry. In the near future, more high-quality innovative products and technologies will emerge to contribute national strength to the development of precision medicine, personalized medicine and high-end medicine.

References

　　[1]Sagomonyants KB,Hakim-Zargar M,Jhaveri A,et al.Porous tantalum stimulates the proliferation and osteogenesis of osteoblasts from elderly female patients[J].J Orthop Res,2011,29(4):609-616.

　　[2]Balla VK,Banerjee S,Bose S,et al.Direct laser processing of a tantalum coating on titanium for bone replacement structures[J].Acta Biomater,2010,6(6):2329-2334.

[3]Cortecchia E,Pacilli A,Pasquinelli G,et al.Biocompatible two-layer tantalum/titania-polymer hybrid coating[J].

　　[4]Bobyn JD,Stackpool GJ,Hacking SA,et al.Characteristics of bone ingrowth and interface mechanics of a new porous tantalum biomaterial[J].J Bone Joint Surg Br,1999,81(5):907-914.

　　[5]Kapat K,Srivas PK,Rameshbabu AP,et al.Influence of Porosity and Pore-Size Distribution inTi(6)Al(4)V Foamon Physicomechanical Properties,Osteogenesis,and Quantitative Validation of Bone Ingrowth by Micro-Computed Tomography[J].ACS Appl Mater Interfaces,2017,9(45):39235-39248.

Huaxiang Medical · Product Introduction

Hunan Huaxiang Medical Technology Co., Ltd. (hereinafter referred to as: Huaxiang Medical) is a high-tech enterprise integrating R & D, production and service. The company is committed to the application research and development of new biological materials, 3D printing medical and other fields, and provides standardized and customized medical devices for precision medicine.

In terms of 3D printing, as of January 2023, more than 14000 cases of personalized 3D printing surgical model guides have been completed. The company has obtained three types of medical device registration certificates based on SLM (Selective Laser Melting) technology: "porous vertebral fusion device" and "porous intervertebral fusion device". In the field of personalized customization, it has cooperated with many medical institutions and achieved outstanding results in the research and development and application of "customized metal 3D printing spinal fusion device; in terms of degradable zinc alloy, the application of human implant surgery will be completed in 2020. In terms of porous tantalum metal, personalized 3D printing porous tantalum metal cushion block implantation knee joint revision surgery was completed in 2017. In January 2023, the company was approved to issue the first three types of medical device registration certificate of bionic trabecular bone structure" additive manufacturing intervertebral fusion device "made of tantalum metal powder.

Statement: This article is not authorized to be reprinted. Some pictures and opinions of the article are from the Internet. They are only for reference and learning exchanges. I hope you can make rational judgments and apply them in a targeted manner. If copyright issues are involved, please contact us to delete them.

Multi-line text content element

HTML language content can be parsed after rich text content is bound to data