CN109771105B - 3D prints porous tantalum interbody fusion cage - Google Patents
3D prints porous tantalum interbody fusion cage Download PDFInfo
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- CN109771105B CN109771105B CN201910060535.0A CN201910060535A CN109771105B CN 109771105 B CN109771105 B CN 109771105B CN 201910060535 A CN201910060535 A CN 201910060535A CN 109771105 B CN109771105 B CN 109771105B
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Images
Abstract
The invention discloses a porous tantalum interbody fusion cage, which is a structural member integrally printed and molded by high-purity tantalum powder through a 3D printing method and comprises a supporting solid structure part and a porous structure part. The supporting solid structure part is used for bearing external load, and the porous structure part is used for guiding the growth of new bone, so that the stability between the implant and the surrounding bone tissue is improved. The volume of the supporting solid structure part accounts for 5 to 20 percent of the total volume of the fusion device, and the solid parts are connected together into a whole. The porous structure part is of an internal communicated pore structure, an open growth space is provided for the growth of surrounding bone tissues, the pore size is 200-800 mu m, and the porosity is 40-80%. The porous tantalum interbody fusion cage provided by the invention provides reliable mechanical support for the spine, and can induce bone to grow into the porous tantalum to form excellent osseointegration with bone tissues, so that the aim of permanent biological internal fixation is fulfilled.
Description
Technical Field
The invention relates to a medical implant, in particular to an osteoinductive porous tantalum interbody fusion cage for treating spinal instability diseases.
Background
Degenerative disc diseases with symptoms of lumbar disc herniation, cervical spondylosis and the like are common diseases and frequently encountered diseases in modern society, and the life quality of patients is seriously affected. Spinal fusion is one of the most common techniques in spinal surgery, and mainly aims to realize long-term stability by establishing instant stability of the spinal and promoting bony fusion of the spinal by using the osteogenesis effect, the osteoinduction effect and the bone conduction effect of an implant.
Currently, intervertebral fusion has become the main means for treating diseases such as unstable lumbar vertebrae, lumbar spinal stenosis, degenerative spondylolisthesis, degenerative scoliosis, prosthetic joints and degenerative intervertebral disc diseases. The intervertebral fusion device made of titanium-based metal is used more clinically, has the defects of limited bone growing capacity and easy instability after being implanted for a long time, and has the problems of low fusion speed, poor fusion effect, unsatisfactory clinical effect and the like in the intervertebral fusion operation due to inconsistent gaps among vertebral bodies of patients and congenital scoliosis or deformity of some patients, thereby bringing much pain to the patients.
Disclosure of Invention
Aiming at the defect of poor bone ingrowth performance of the porous titanium interbody fusion cage, the invention designs the 3D printing porous tantalum interbody fusion cage which is customized individually and has more excellent bone ingrowth activity, and the interbody fusion cage is designed completely according to the anatomical structure of a patient and is completely matched with the geometric dimension of the implanted part of the patient.
The technical scheme involved in the invention is as follows: firstly, the invention discloses a porous tantalum material with a three-dimensional communicated pore channel structure, which has a porous structure similar to a human trabecula bone, all pore channels of the material are communicated together to ensure that the human bone tissue completely grows into the porous tantalum material, and secondly, the porous tantalum material is used as a basis to design a porous tantalum interbody fusion cage.
The specific scheme is as follows:
the porous tantalum interbody fusion cage is prepared by 3D printing of high-purity tantalum serving as a base material, has sufficient mechanical properties and is suitable for bone growth into a pore structure. The porous tantalum interbody fusion cage has the pore size of 200-800 microns, the porosity of 40-80%, the compressive strength of 50-200 MPa and the elastic modulus of 2-30 GPa. The preparation method of the 3D printing porous tantalum interbody fusion cage comprises the following steps:
(1) designing a three-dimensional geometric model of the porous tantalum interbody fusion cage by using mapping software so that the three-dimensional geometric model can be matched with the anatomical structure of a human vertebral body;
(2) according to the three-dimensional geometric model of the porous tantalum interbody fusion cage obtained in the step (1), high-purity tantalum powder is used as a raw material, and integrated 3D printing is carried out under the protection of argon atmosphere to obtain a printing piece of the porous tantalum interbody fusion cage; wherein the 3D printing process parameters are as follows: the powder spreading thickness is 30-50 mu m, the laser power is 120-300W, the exposure time is 20-100 mu s, the spot spacing is 20-70 mu m, and the line spacing is 20-70 mu m;
(3) carrying out high-temperature heat treatment on the printing piece of the porous tantalum interbody fusion cage obtained in the step (2) under the argon protective atmosphere to eliminate residual stress, and cooling; wherein the heat treatment conditions are as follows: the temperature is 1200-2000 ℃, and the heat preservation time is 1 hour;
(4) performing sand blasting treatment on the porous tantalum interbody fusion cage printing piece obtained in the step (3) to remove metal powder adhered to the surface; wherein the sand blasting pressure is 0.1-1 MPa, and the sand blasting time is 30-120 s;
(5) and (4) ultrasonically cleaning the printing piece of the porous tantalum interbody fusion cage obtained in the step (4), and drying in a nitrogen atmosphere to obtain the porous tantalum interbody fusion cage.
Further, in the step (1), the drawing software is Auto CAD, Pro E (Pro/Engineer), Magics, etc.
Further, in the step (2), the high-purity tantalum is medical-grade spherical high-purity tantalum metal powder, the purity is more than or equal to 99.99 wt%, and the particle size is 15-45 μm.
Further, in the step (4), the sand blasting material is white corundum, and the grain size of the white corundum is 10-100 μm.
Further, in the step (5), the ultrasonic cleaning is as follows: and (3) ultrasonically cleaning the glass substrate for 30-120 seconds by using acid, and then respectively ultrasonically cleaning the glass substrate for 15-30 minutes by using acetone, alcohol and distilled water in sequence.
Further, the acid is a mixed solution of hydrofluoric acid and nitric acid, and is prepared by adding 2mL of 48% hydrofluoric acid and 3mL of 70% concentrated nitric acid into 100mL of distilled water.
Further, in the step (5), the drying temperature is 40-60 ℃.
The porous tantalum interbody fusion cage is manufactured by a 3D printing method, so that the personalized customization requirements are met, the porous tantalum interbody fusion cage which is completely matched with the anatomical structure of each patient is manufactured according to different pathological conditions of each patient, and the stability of the implant is improved.
The porous tantalum interbody cage is composed of a solid support portion and a porous portion. Namely, the porous tantalum interbody fusion cage is a pore structure formed by a solid support part and a porous part. The solid supporting part provides necessary mechanical support for the spine, the porous part has the performance of inducing bone growth, and after the porous tantalum interbody fusion cage is implanted for a period of time, the porous tantalum interbody fusion cage and surrounding bone tissues grow together to form a whole, so that the purpose of permanent fusion is achieved, long-term mechanical support is provided for the spine at the implanted part, and the occurrence of fixation instability is avoided.
Further, the 3D printing process is carried out under the argon protective atmosphere, and the oxygen content of the working cavity is lower than 1000 ppm in the printing process.
Further, the porous tantalum interbody fusion cage is printed by a selective laser melting method.
Furthermore, the printing substrate is made of high-purity tantalum, the purity is more than or equal to 99.99 wt%, and the heating temperature of the substrate is 150-400 ℃ in the printing process.
Further, the pore structures are interconnected pore structures, and provide a suitable space for inducing bone ingrowth. Furthermore, the porous tantalum interbody fusion cage is connected with one another into a whole through the solid support parts, and mechanical support is provided for the implantation position.
Furthermore, the density of the solid support part reaches more than 99.9 percent, the volume fraction of the solid support part is 5-20 percent, the volume fraction of the porous part is 80-95 percent, the pore size of the porous part is 200-800 mu m, the porosity is 40-80 percent, and the porous part is of a mutually communicated pore structure.
Furthermore, the porous tantalum interbody fusion cage manufactured by 3D printing has the solid support part accounting for 5-20% of the volume fraction and being a whole body connected together, the porous part accounting for 80-95% of the volume fraction, the pore size of the porous part being 200-800 microns, the porosity being 40-80%, the compressive strength of the interbody fusion cage being 50-200 MPa, and the elastic modulus being 2-30 GPa.
The interbody fusion cage is a structural member integrally printed and molded by high-purity tantalum powder through a 3D printing method, and comprises a supporting solid structure part and a porous structure part. The supporting solid structure part is used for bearing external load, and the porous structure part is used for guiding the growth of new bone, so that the stability between the implant and the surrounding bone tissue is improved. The volume of the supporting solid structure part accounts for 5 to 20 percent of the total volume of the fusion device, and the solid parts are connected together into a whole. The porous structure part is of an internal communicated pore structure, an open growth space is provided for the growth of surrounding bone tissues, the pore size is 200-800 mu m, and the porosity is 40-80%. The porous tantalum interbody fusion cage provided by the invention provides reliable mechanical support for the spine, and can induce bone to grow into the porous tantalum to form excellent osseointegration with bone tissues, so that the aim of permanent biological internal fixation is fulfilled.
The invention has the beneficial effects that:
the personalized customized 3D printed porous tantalum interbody fusion cage is customized according to the size and shape of the interbody of a patient and is directly printed by a 3D printer, a printed piece is completely matched with the size of the lumbar vertebra of the patient, the comfort level of the patient is improved, tantalum metal is very stable in the human body environment, is a parent biological metal and does not release toxic ions in the body for a long time, meanwhile, the 3D printed porous tantalum interbody fusion cage easily realizes the structural characteristic that the solid part and the porous part of the fusion cage are completely and tightly combined together, the solid part has sufficient mechanical strength, the purpose of providing sufficient mechanical support for the implanted part is met, the porous part improves the friction force between the implant and the implanted part, the stability of the initial stage of implantation is improved, meanwhile, the porous tantalum metal has the characteristics of good bone integration and bone induction, and induces new bone tissues to grow into the porous tantalum metal, the new bone and the tantalum metal surface form ideal osseous combination, and the long-term stability of the implant is ensured.
Drawings
The invention will be further described with reference to the accompanying drawings in which:
fig. 1 is a picture of a porous tantalum cage prepared by 3D printing according to the present invention, which is composed of a solid portion providing a mechanical support effect and a porous portion inducing new bone ingrowth.
FIG. 2 is a photomicrograph of a porous tantalum cage prepared by 3D printing according to example 1, having a pore size of about 500 μm in the porous portion and a pillar beam size of 30 μm.
Fig. 3 is a graph showing the mechanical properties of the porous tantalum intervertebral cage manufactured by 3D printing according to example 1, which can withstand a pressure of about 700N.
Fig. 4 is a photograph of a live-dead-staining of stem cells of the porous tantalum cage fabricated by 3D printing according to example 1, showing that the cage has good biocompatibility.
Fig. 5 is a picture of the porous tantalum endosteal bone ingrowth of the porous tantalum intervertebral cage fabricated by 3D printing according to example 1, showing that the cage can induce new bone ingrowth.
Detailed Description
The embodiments of the present invention will be described in detail below with reference to the accompanying drawings: the following examples are carried out on the premise of the technical scheme of the invention, and detailed embodiments and specific operation processes are given, but the scope of the invention is not limited to the following examples.
The raw material high-purity tantalum used in the embodiment is medical-grade spherical high-purity tantalum metal powder, the purity is more than or equal to 99.99 wt%, and the particle size of the powder is 15-45 μm.
Example 1
As shown in fig. 1, a porous tantalum interbody fusion cage is made by using high-purity tantalum as a base material and realizing personalized customization of the porous tantalum interbody fusion cage through 3D printing. The fusion cage is divided into a support structure portion (solid support portion) and a void structure portion (porous portion) according to the difference in roles. The porous tantalum interbody fusion cage is a pore structure formed by a solid support part and a porous part. The gap structure parts are fixedly connected together in an integrated manner, and the pores are completely communicated, so that the new bone can be guided to completely grow in. The volume of the support structure part accounts for 20 percent of the total volume of the fusion cage, and the support structure part is used for bearing external loads and providing necessary mechanical support for the spine. The porous part accounts for 80 percent of the total volume of the fusion device, the pore size of the porous part is 500 mu m, the porosity is 70 percent, the porous part has the performance of inducing bone ingrowth, and after the porous tantalum intervertebral fusion device is implanted for a period of time, the porous tantalum intervertebral fusion device and surrounding bone tissues grow together to form a whole, so that the purpose of permanent fusion is achieved, long-term mechanical support is provided for the spine of the implanted part, and the occurrence of fixation instability is avoided.
The porous structure portion in this embodiment is formed by combining porous units based on a diamond structure having a regular tetrahedral structure, and the void units are connected to each other in a manner of connecting carbon atoms in the diamond structure. Wherein, the structural units are formed by connecting 4 cuboid columnar titanium columns with the same length according to a regular tetrahedron structure. The included angle between the tantalum columns is 109 degrees and 28 minutes. Each tantalum column has a length of 0.6mm and a width and thickness of 0.2 mm. The porosity of the void structure portion was 70%.
The porous structure of the porous tantalum interbody fusion cage is a diamond-shaped porous structure unit, the porosity is 70%, the pore size is 500 microns, the porous tantalum metal has the property of inducing the bone tissue to grow in, so that the porous tantalum metal interbody fusion cage and the surrounding bone tissue grow together, the surface of the porous tantalum metal interbody fusion cage is rough, the stability of the porous tantalum metal interbody fusion cage at the initial stage of implantation is facilitated, the dislocation after implantation is prevented, and the interbody fusion cage and the surrounding bone tissue form a whole along with the growth of the bone tissue into the porous tantalum metal, so that the long-term stability of the interbody fusion cage is; meanwhile, the tantalum metal is a medical metal material which is extremely stable in the human body environment, and the tantalum metal does not release metal ions in the body for a long time, so that the biological toxicity is not generated; in addition, the compressive strength of the porous tantalum metal interbody fusion cage is about 50MPa, the elastic modulus is about 10GPa, and the porous tantalum metal interbody fusion cage is matched with the elastic modulus of surrounding bone tissues, so that the stress shielding effect can be effectively avoided, and the effect of accelerating bone reconstruction is achieved.
The preparation method of the porous tantalum interbody fusion cage comprises the following specific implementation steps:
(1) the shape design of the interbody fusion cage is carried out by Computer Aided Design (CAD) software, so that the shape of the interbody fusion cage can be matched with the anatomical shape of a human vertebral body; the CAD software is Auto CAD, Pro/E, Magics and the like; in this embodiment, the volume of the support structure accounts for 20% of the total volume of the fusion cage, the pore size of the porous part is 500 μm, and a stl format file of a three-dimensional geometric model of the porous tantalum intervertebral fusion cage is obtained;
(2) and (3) taking high-purity tantalum spherical powder as a raw material, and carrying out integrated 3D printing and manufacturing by using a metal 3D printer to obtain the porous tantalum interbody fusion cage. In the printing process, the power of the laser is 180W, the exposure time is 30 Mus, the spot-to-spot distance is 30 Mum, the line distance is 30 Mum, and the powder spreading thickness is 30 Mum. The substrate temperature during printing was 170 ℃.
(3) After printing, cutting off the printed part from the substrate by using a linear cutting method, carrying out heat treatment at 1250 ℃ for 1 hour under the argon protective atmosphere to eliminate residual stress, and naturally cooling along with the furnace.
(4) After the heat treatment, the printed piece is placed in a sand blasting machine for sand blasting treatment, and residual metal powder is removed through the sand blasting treatment, wherein the powder used for sand blasting is white corundum with the particle size of 50 microns, the sand blasting pressure is 0.3MPa, and the sand blasting time is 30 seconds.
(5) After sand blasting, a printed piece is firstly ultrasonically cleaned for 30s by using mixed acid of hydrofluoric acid and nitric acid (48% of hydrofluoric acid, 2mL of concentrated nitric acid and 70%, 3mL of concentrated nitric acid and 100mL of distilled water), then respectively ultrasonically cleaned for 30 minutes by sequentially using acetone, alcohol and distilled water, and then is dried in nitrogen atmosphere at 40 ℃.
Example 2
As shown in fig. 1, a porous tantalum interbody fusion cage is made by using high-purity tantalum as a base material and realizing personalized customization of the porous tantalum interbody fusion cage through 3D printing. The fusion cage is divided into a support structure portion (solid support portion) and a void structure portion (porous portion) according to the difference in roles. The porous tantalum interbody fusion cage is a pore structure formed by a solid support part and a porous part. The gap structure parts are fixedly connected together in an integrated manner, and the pores are completely communicated, so that the new bone can be guided to completely grow in. The volume of the support structure part accounts for 10 percent of the total volume of the fusion cage, and the support structure part is used for bearing external loads and providing necessary mechanical support for the spine. The porous part accounts for 90 percent of the total volume of the fusion cage, the pore size of the porous part is 600 mu m, the porosity is 50 percent, the porous part has the performance of inducing bone ingrowth, and after the porous tantalum intervertebral fusion cage is implanted for a period of time, the porous tantalum intervertebral fusion cage and surrounding bone tissues grow together to form a whole, thereby achieving the purpose of permanent fusion, providing long-term mechanical support for the spine of the implanted part and avoiding the occurrence of fixation instability.
The porous structure portion in this embodiment is formed by combining porous units based on a diamond structure having a regular tetrahedral structure, and the void units are connected to each other in a manner of connecting carbon atoms in the diamond structure. Wherein, the structural units are formed by connecting 4 cuboid columnar titanium columns with the same length according to a regular tetrahedron structure. The included angle between the tantalum columns is 109 degrees and 28 minutes. Each tantalum column has a length of 0.6mm and a width and thickness of 0.2 mm. The porosity of the void structure portion was 60%.
The porous structure of the porous tantalum interbody fusion cage is a diamond-shaped porous structure unit, the porosity is 60%, the pore size is 600 microns, the porous tantalum metal has the performance of inducing the bone tissue to grow in, so that the porous tantalum metal interbody fusion cage and the surrounding bone tissue grow together, the surface of the porous tantalum metal interbody fusion cage is rough, the stability of the porous tantalum metal interbody fusion cage at the initial stage of implantation is facilitated, the dislocation after implantation is prevented, and the interbody fusion cage and the surrounding bone tissue form a whole along with the growth of the bone tissue into the porous tantalum metal, so that the long-term stability of the interbody fusion cage is; meanwhile, the tantalum metal is a medical metal material which is extremely stable in the human body environment, and the tantalum metal does not release metal ions in the body for a long time, so that the biological toxicity is not generated; in addition, the compressive strength of the porous tantalum metal interbody fusion cage is about 50MPa, the elastic modulus is about 10.8GPa, and the porous tantalum metal interbody fusion cage is matched with the elastic modulus of surrounding bone tissues, so that the stress shielding effect can be effectively avoided, and the effect of accelerating bone reconstruction is achieved.
The preparation method of the porous tantalum interbody fusion cage comprises the following specific implementation steps:
(1) the shape design of the interbody fusion cage is carried out by Computer Aided Design (CAD) software, so that the shape of the interbody fusion cage can be matched with the anatomical shape of a human vertebral body; the CAD software is Auto CAD, Pro/E, Magics and the like; in this embodiment, the volume of the support structure accounts for 10% of the total volume of the fusion cage, the pore size of the porous part is 600 μm, and a stl format file of a three-dimensional geometric model of the porous tantalum intervertebral fusion cage is obtained;
(2) and (3) taking high-purity tantalum spherical powder as a raw material, and carrying out integrated 3D printing and manufacturing by using a metal 3D printer to obtain the porous tantalum interbody fusion cage. In the printing process, the power of the laser is 120W, the exposure time is 50 mu s, the spot-to-spot distance is 60 mu m, the line distance is 60 mu m, and the powder spreading thickness is 60 mu m. The substrate temperature during printing was 170 ℃.
(3) After printing, cutting off the printed part from the substrate by using a linear cutting method, carrying out heat treatment at 1550 ℃ for 1 hour under the argon protective atmosphere to eliminate residual stress, and naturally cooling along with the furnace.
(4) After the heat treatment, the printed piece is placed in a sand blasting machine for sand blasting treatment, and residual metal powder is removed through the sand blasting treatment, wherein the powder used for sand blasting is white corundum with the particle size of 50 microns, the sand blasting pressure is 0.3MPa, and the sand blasting time is 30 seconds.
(5) After sand blasting, a printed piece is firstly ultrasonically cleaned for 30s by using mixed acid of hydrofluoric acid and nitric acid (48% of hydrofluoric acid, 2mL of concentrated nitric acid and 70%, 3mL of concentrated nitric acid and 100mL of distilled water), then respectively ultrasonically cleaned for 30 minutes by sequentially using acetone, alcohol and distilled water, and then is dried in nitrogen atmosphere at 40 ℃.
The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art should be considered to be within the technical scope of the present invention, and the technical solutions and the inventive concepts thereof according to the present invention should be equivalent or changed within the scope of the present invention.
Claims (7)
1. The porous tantalum interbody fusion cage is a porous tantalum interbody fusion cage with osteoinduction activity, which is prepared by 3D printing on high-purity tantalum serving as a base material, and the preparation method of the porous tantalum interbody fusion cage comprises the following steps:
(1) designing a three-dimensional geometric model of the porous tantalum interbody fusion cage by using mapping software;
(2) according to the three-dimensional geometric model of the porous tantalum interbody fusion cage obtained in the step (1), high-purity tantalum powder is used as a raw material, and integrated 3D printing is carried out under the protection of argon atmosphere to obtain a printing piece of the porous tantalum interbody fusion cage; wherein the 3D printing process parameters are as follows: the powder spreading thickness is 30-50 mu m, the laser power is 120-300W, the exposure time is 20-100 mu s, the spot spacing is 20-60 mu m, and the line spacing is 20-60 mu m;
(3) carrying out heat treatment on the printing piece of the porous tantalum interbody fusion cage obtained in the step (2) under the argon protective atmosphere, and cooling; wherein the heat treatment conditions are as follows: the temperature is 1200-2000 ℃, and the heat preservation time is 1 hour;
(4) performing sand blasting treatment on the printing piece of the porous tantalum interbody fusion cage obtained in the step (3); wherein the sand blasting pressure is 0.1-1 MPa, and the sand blasting time is 30-120 s;
(5) cleaning the printing piece of the porous tantalum interbody fusion cage obtained in the step (4), and drying the printing piece in a nitrogen atmosphere to obtain the porous tantalum interbody fusion cage;
in the step (2), the high-purity tantalum is medical-grade spherical high-purity tantalum metal powder, the purity is more than or equal to 99.99 wt%, and the particle size is 15-45 mu m;
in the step (5), the cleaning is as follows: ultrasonic cleaning is carried out for 30-120 seconds by using acid, and then ultrasonic cleaning is carried out for 15-30 minutes by using acetone, alcohol and distilled water in sequence;
the porous tantalum interbody fusion cage is characterized in that the pore size is 200-800 microns, the porosity is 40-80%, the compressive strength is 50-200 MPa, and the elastic modulus is 2-30 GPa.
2. The porous tantalum intersomatic cage of claim 1, wherein in step (2), the substrate temperature during printing is 150 to 400 ℃.
3. The porous tantalum interbody fusion cage of claim 1, wherein in step (4), the sand-blasting material is white corundum, and the grain size of the white corundum is 10 to 100 μm.
4. The porous tantalum intersomatic cage of claim 1, wherein, in step (5), said drying temperature is 40-60 ℃.
5. The porous tantalum intersomatic cage of claim 1, wherein in step (1), said mapping software is Auto CAD, Pro/Engineer, Magics.
6. The porous tantalum intersomatic cage of claim 1, wherein the pore structure of the porous tantalum intersomatic cage is an interconnected pore structure providing a suitable space for inducing bone ingrowth.
7. The porous tantalum intersomatic cage of claim 1, wherein said porous tantalum intersomatic cage is integrally connected to each other by solid portions to provide mechanical support to the implantation site.
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CN110421172A (en) * | 2019-08-27 | 2019-11-08 | 西安九洲生物材料有限公司 | A method of medical porous tantalum part is prepared based on selective laser melting process |
CN112155806B (en) * | 2020-10-23 | 2023-12-19 | 中国人民解放军空军军医大学 | Vertebral column posterior reconstruction device after laminectomy |
CN113319291A (en) * | 2021-04-21 | 2021-08-31 | 中国科学院金属研究所 | Preparation method of recoverable individualized customized femoral stem based on 4D printing shape |
CN113017939A (en) * | 2021-04-27 | 2021-06-25 | 深圳大洲医学科技有限公司 | Intervertebral fusion cage and preparation method thereof |
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