WO2015010223A1

WO2015010223A1 - Apparatus and method for fabricating personalized intervertebral disc artificial nucleus prosthesis

Info

Publication number: WO2015010223A1
Application number: PCT/CN2013/001250
Authority: WO
Inventors: 林杨; 曹汉辉; 张忠峰; 付源博; 高瑾; 林均利; 董长和
Original assignee: Lin Yang; Cao Hanhui
Priority date: 2013-07-23
Filing date: 2013-10-15
Publication date: 2015-01-29
Also published as: CN103340705A; CN103340705B

Abstract

An apparatus and a method of fabricating a personalized intervertebral disc artificial nucleus prosthesis. The apparatus comprises an information collector (1), a central processing unit (2) and a 3D printer (3). The information collector (1) is connected to the 3D printer (3) through the central processing unit (2), and a printing head of the 3D printer (3) is provided with medical polymer materials. A fabricated artificial nucleus prosthesis (4) is long-bar-shaped, the width of the manufactured artificial nucleus prosthesis is 2-6 mm, the thickness of the manufactured artificial nucleus prosthesis is 5-9 mm, and the overall appearance of the artificial nucleus prosthesis is in a spiral state. According to outer dimensions after spiraling, the longitudinal diameter is 8-22 mm, and the horizontal diameter is 18-38 mm. The apparatus fabricates artificial nucleus prostheses meeting the requirements according to nucleus sizes of different users in a personalized mode, and is used for treatment of lumbar intervertebral disc diseases, overcomes the defects that an artificial nucleus prosthesis fabricated with the existing technology can only have several fixed specifications and cannot meet practical needs, and solves the problems that the interior of the disc is unstable and displacement happens caused by the fact that the sizes of the artificial nucleus prostheses do not fit the users.

Description

Personalized intervertebral disc artificial nucleus prosthesis manufacturing device and method

The invention belongs to the field of medical instruments, and relates to a device and a method for manufacturing a personalized intervertebral disc artificial nucleus prosthesis.

Background technique

The intervertebral disc is the largest avascular tissue in the human body. It is a highly specific structure composed of various connective tissues, including the nucleus pulposus, the annulus fibrosus and the cartilage endplate. These structures are arranged in an orderly and rational manner to make the intervertebral discs perform normal physiological functions. Due to external factors or / and aging caused by ageing, the intervertebral disc is degeneratively altered. The clinical manifestations are pain in the waist and legs, and the disc function is severe in severe cases.

At present, the traditional treatment for degenerative disc disease is intervertebral disc nucleus pulposus or spinal fusion. The former requires surgical removal of the nucleus pulposus. The removal of the functional disc nucleus will inevitably lead to a decrease in intervertebral height, which may easily lead to disc herniation. Loss of biomechanical properties, potentially causing further risk of disc degeneration; the latter induces osteogenesis between endplates due to fusion of vertebral bodies, although it can stabilize the lesion area, but reduces the range of motion of the spine, due to the compensation of the spine The effect can lead to the degeneration of adjacent segments, and because it is a highly invasive procedure, the surgical trauma is large, so the above two methods can relieve the patient's pain to some extent, but there are such or Such complications.

For 75 years, many surgeons and engineers have tried to design and develop artificial intervertebral discs to maintain the mobility of the diseased disc segments and prevent degeneration of other segments. According to the thirteenth chapter of the thirteenth chapter in the "Spine Intervertebral Arthroplasty" edited by Jin Dadi, Qi Dongbin, and Charles D. Ray, published by the Science and Technology Literature Publishing House in June 2004, there are about 100 artificial intervertebral discs. Patented, but very few have been put into clinical trials through platform load tests, cadaver specimens or animal implant tests. The fourth section of the book provides a lumbar intervertebral disc artificial nucleus prosthesis, which is made of a high molecular polyethylene sheath and a semi-flowing hydrogel nucleus (polypropylene nitrile-polyacrylamide copolymer). Its shape is wedge-shaped and rectangular, invented by Dr. Charles D.Ray, and is currently the only artificial nucleus prosthesis used in clinical practice. The artificial nucleus of the intervertebral disc can fully absorb 80% of its own weight after being fully expanded, and its volume can be changed with the load. When used, it is combined with a special fiber loop expander, laminar spreader, prosthetic test membrane, and implant. Into the guide, prosthesis forceps, round head thruster, elbow positioner and other equipment. The above-mentioned lumbar intervertebral disc artificial nucleus prosthesis has been widely used in Europe, and more than 3,000 patients worldwide have undergone this prosthetic implantation. Postoperative follow-up investigation found that the clinical effect is not very satisfactory, the problem is the displacement of the implanted prosthesis; In addition, when implanting the artificial nucleus prosthesis of the lumbar intervertebral disc, the surgical procedure and the conventional posterior approach Laminectomy, nucleus pulposus removal is the same, laminectomy to remove bone tissue at least 12mm wide working channel to insert the operating instrument, so the trauma is large.

In response to the above problems, Chinese patent ZL200620020591.X designed an artificial nucleus prosthesis implanted percutaneously into the intervertebral disc. The prosthesis has a long strip shape and is in a spiral state. The utility model does not require surgery. Skin puncture The working channel established when the nucleus pulposus is removed, the novel is opened, implanted through the working channel, the operation is simple, and the trauma is small; after implantation, the structure of the intervertebral disc is not affected, and the stability is stable, and the normal intervertebral disc can be effectively ensured after recovery. Biomechanical function. Although the prosthesis can overcome the problem of large trauma implantation, the size and shape of the human intervertebral disc are different. The prosthesis can only be made into several specifications according to the measurement of the human body, which cannot meet the clinical requirements. Actual requirements, and if the size of the prosthesis does not match, it is easy to bring many drawbacks, such as intra-plate instability, shifting and so on. Therefore, it is necessary to design an intervertebral disc artificial nucleus prosthesis manufacturing device that can be personalized according to different patient characteristics.

A 2D printer, a machine for rapid prototyping technology, is a digital model file that uses a bondable material such as powdered metal or plastic to construct an object by layer-by-layer printing. In the past, it was often used in mold manufacturing and industrial design to make models, and it is gradually being used for the direct manufacture of some products, which means that this technology is becoming popular. Applying 3D printers to the medical field may provide a new way to personalize the design of intervertebral disc artificial nucleus prosthesis. Summary of the invention

The object of the present invention is to provide a personalized intervertebral disc artificial nucleus prosthesis manufacturing device, which can solve the problem that the existing artificial nucleus pulposus prosthesis can not be personalized according to the characteristics of the patient, and it is easy to be unstable and displaced due to the size mismatch. And other issues.

Another object of the present invention is to provide a method of manufacturing a personalized intervertebral disc artificial nucleus prosthesis.

The invention is achieved by the following technical solutions:

A personalized intervertebral disc artificial nucleus prosthesis manufacturing device, the device comprises an information collecting instrument, a central processing unit and a 3D printer, the information collecting instrument is connected by a central processing unit and a 3D printer, and the print head of the 3D printer is equipped with a medical device. Polymeric material; the artificial nucleus prosthesis manufactured is strip-shaped, with a width of 2-6mm and a thickness of 5-9mm. The overall appearance is in a spiral state. The shape after the spiral is 8-22mm in longitudinal diameter. It is 18-38mm.

The information collecting instrument is a magnetic resonance imaging system (MRI) or a computed tomography system (CT). The medical polymer material is a polyvinyl alcohol hydrogel.

As a further improvement of the present invention, a database is further included, and the database is compiled from data collected by the information collecting instrument.

Second, a method for manufacturing a personalized intervertebral disc artificial nucleus prosthesis, the method comprising the following steps:

(1) The information collecting instrument collects data and transmits it to the 3D printer through the central processing unit;

(2) The 3D printer prints the medical polymer material according to the data to manufacture the artificial nucleus prosthesis;

(3) Compile the data collected by the information collector into database storage.

The positive effect of the above technical solution: The invention can personalize the artificial nucleus pulposus prosthesis according to the nucleus pulposus size of different patients, and is used for treating lumbar intervertebral disc disease, overcoming the existing artificial nucleus pulposus prosthesis only Produced a fixed number of specifications, can not meet the actual needs of the problem, thus solving the problem of instability, displacement, etc. caused by the inconsistent size of the artificial nucleus prosthesis; in addition, the collected patient data is compiled into a database, Easy for subsequent comparison work, if The patient who encounters data coincidence can directly print the nucleus pulposus prosthesis, and does not need to repeat the previous work, saving time and effort.

DRAWINGS

Figure 1 is a schematic view of the present invention;

Figure 2 is a schematic view showing the state of development of the artificial nucleus pulposus prosthesis;

m 3 is a schematic view of the state of manufacture of the artificial nucleus prosthesis.

In the figure, 1 information collector, 2 central processing unit, 3 3D printer, 4 artificial nucleus prosthesis, 5 database.

detailed description

The technical solutions of the present invention are further illustrated by the following examples and test examples, but are not to be construed as limiting the present invention:

Example 1

1 is a schematic view of the present invention, FIG. 2 is a schematic view showing the state of deployment of the artificial nucleus pulposus prosthesis, and FIG. 3 is a schematic view showing the state of the artificial nucleus prosthesis prosthesis, as shown in FIG. 1, FIG. 2, and FIG. A personalized intervertebral disc artificial nucleus prosthesis manufacturing device, the device comprises an information collecting instrument 1, a central processing unit 2 and a 3D printer 3, and the information collecting instrument 1 is connected by a central processing unit 2 and a 3D printer 3, and the 3D printer 3 The print head is filled with medical polymer material. The information collecting instrument 1 is a magnetic resonance imaging system (MRI) or a computed tomography system (CT), and the MRI and CT are used to collect the size data of the human nucleus pulposus and transmit it to the 3D printer through the central processing unit 2 Provides a data foundation for the 3D printer 3 to print artificial nucleus prosthesis. The medical polymer material may use some high polymers, for example, polyethylene, polypropylene, etc. The medical polymer material in the present invention is a polyvinyl alcohol hydrogel, which has been clinically proven to have no toxic effect on the human body. Up to 50 years. The manufactured artificial nucleus prosthesis 4 is elongated, has a width of 2-6 mm, a thickness of 5-9 mm, and has an overall appearance in a spiral state. The shape after the hoop is 8-22 mm in longitudinal direction and 18-direction in lateral diameter. 38mm. The advantage of the artificial nucleus pulposus prosthesis 4 is that the artificial nucleus prosthesis is opened without the need of surgery, and then the working channel established by percutaneous puncture removal of the nucleus pulposus is implanted, the operation is simple, the trauma is small, and after implantation The artificial nucleus pulposus prosthesis is spirally filled in the intervertebral disc, which does not affect the structural integrity of the intervertebral disc, and has good stability, and can effectively ensure the biomechanical function of the normal intervertebral disc after recovery.

As a further improvement of the present invention, a database 5 is also included, and the database 5 is compiled from data collected by the information collecting instrument 1. Because the entire production process takes a long time, the advantage of making a database is that the collected patient data can be stored to a greater extent. When the patient data is re-acquired, the existing data in the database can be compared first. If it overlaps with the existing data, it does not need to be redesigned. It only needs to be printed directly, saving time and effort.

Example 2

A method for manufacturing a personalized intervertebral disc artificial nucleus prosthesis, the method comprising the following steps:

(1) The information collecting instrument 1 collects data and transmits it to the 3D printer 3 through the central processing unit 2, which is a 3D printer. -

Print out the artificial nucleus prosthesis to provide a data base;

(2) 3D printer 3 according to the data collected by the information collecting instrument 1, the medical polymer material is printed and molded to produce an artificial nucleus prosthesis 4;

(3) Compiling the data collected by the information collecting instrument 1 into the database 5 for storage, providing data support for future work. When re-collecting the patient data, it can first compare with the existing data in the database, if and existing If the data overlaps, you don't need to redesign it. Just print it directly.

Test case

The technical solution of the present invention has passed the fresh cadaver test, and the research result is reliable because the fresh corpse is close to the normal state of the human body. The size of the nucleus pulposus was measured by MRI. According to the data, the artificial nucleus pulposus prosthesis conforming to the nucleus pulposus size was designed. After the artificial nucleus pulposus prosthesis was implanted into the cadaver, the MRI reacquired the data and compared with the above data. It was found that the prosthesis was well fitted to the intervertebral disc after implantation and reached the target. The corpse was then dissected and found to be non-displaced or unstable after implantation.

It has been proved that the invention can be personalized according to the different sizes of the patient's nucleus pulposus, and the artificial nucleus pulposus prosthesis precisely conforms to the size of the patient can be produced, which overcomes the problem that the artificial nucleus pulposus prosthesis has only several fixed specifications, and effectively prevents Due to the size of the prosthesis does not match the problem of instability, displacement, etc. in the disk.

Claims

Claims—WO 2015/010223 PCT/CN2013/001250

1. A personalized intervertebral disc artificial nucleus pulposus prosthesis manufacturing device, characterized in that: the device includes an information collection instrument (1), a central processing unit (2) and a 3D printer (3). The information collection instrument (1) passes through the central The processor (2) is connected to the 3D printer (3), and the print head of the 3D printer (3) is equipped with medical polymer material; the manufactured artificial nucleus pulposus prosthesis (4) is in the shape of a long strip with a width of 2-6mm. , the thickness is 5-9mm, the overall appearance is in a spiral state, the outer dimensions after spiraling are 8-22mm in longitudinal diameter and 18-38mm in transverse diameter.

2. The personalized intervertebral disc artificial nucleus pulposus prosthesis manufacturing device according to claim 1, characterized in that: the information acquisition instrument (1) is an MRI system or a computed tomography system.

3. The personalized intervertebral disc artificial nucleus pulposus prosthesis manufacturing device according to claim 1, characterized in that: the medical polymer material is polyvinyl alcohol hydrogel.

4. The personalized intervertebral disc artificial nucleus pulposus prosthesis manufacturing device according to claim 1, characterized in that: it also includes a database (5), the database (5) is a compilation of data collected by the information collection instrument (1) Become.

5. A method for manufacturing a personalized intervertebral disc artificial nucleus pulposus prosthesis, characterized by: The method includes the following steps:

(1) Information collector (1) collects data and transmits it to the 3D printer through the central processor (2) G);

(2) A 3D printer (3) prints medical polymer materials based on the data to create an artificial nucleus pulposus prosthesis (4);

(3) Compile the data collected by the information collector (1) into a database (5) for storage.