CN100434049C - Double-layered bionic pseudo-structure of cervical intervertebral disci, and its mfg. process - Google Patents
Double-layered bionic pseudo-structure of cervical intervertebral disci, and its mfg. process Download PDFInfo
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- CN100434049C CN100434049C CNB2005100417947A CN200510041794A CN100434049C CN 100434049 C CN100434049 C CN 100434049C CN B2005100417947 A CNB2005100417947 A CN B2005100417947A CN 200510041794 A CN200510041794 A CN 200510041794A CN 100434049 C CN100434049 C CN 100434049C
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- mould
- fibrous ring
- nucleus prosthesis
- prosthesis
- prosthese
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
Abstract
The present invention relates to a double-layer bionic cervical intervertebral disc prosthesis structure and a manufacturing technology thereof. Firstly, CAD is used for constructing the prototype of a human intervertebral disc, a fiber ring prosthesis mould and a nucleus pulposus prosthesis mould superposed with the centroid of the fiber ring prosthesis mould are obtained by rapid forming, dissolved polyvinyl alcohol water solution is filled in the nucleus pulposus prosthesis mould, and a nucleus pulposus prosthesis is obtained; the nucleus pulposus prosthesis is fixed in the fiber ring prosthesis mould, and simultaneously an L-shaped fixed device is fixed in the fiber ring prosthesis mould; the fiber ring prosthesis mould is put in polyurethane solution prepared by polyurethane and solidification liquid corresponding to the type of the polyurethane and solidified, and an artificial intervertebral disc prosthesis is obtained. The artificial intervertebral disc prosthesis made according to the technology comprises a cylindrical fiber ring prosthesis similar to the outline of a human cervical vertebra, and a cylindrical nucleus pulposus prosthesis superposed with the centroid of the fiber prosthesis and arranged in the fiber ring prosthesis, wherein the distance between the bottom edge of the nucleus pulposus prosthesis and the bottom edge of the fiber prosthesis is 2.25mm, and the cylindrical diameter difference between the fiber ring prosthesis and the nucleus pulposus prosthesis is 6.88mm.
Description
Technical field
The invention belongs to the manufacturing engineering field, particularly a kind of double-layered bionic pseudo-structure of cervical intervertebral disci and manufacturing process thereof.
Background technology
Cervical spondylosis is human commonly encountered diseases and a frequently-occurring disease of puzzlement, and present operation method is a lot, and simple disc removal art, spinal fusion, various internal fixation devices etc. are arranged.For simple disc removal art, the height of intervertebral space can not get recovering, and causes the factor of compressing fundamentally not remove to nerve root; Though and various fusion and internal fixation device have recovered the height of intervertebral space, but it is bigger to the inherent mechanical environment influence of spinal column, make the operation sections of spinal column lose motor function, cause the biomechanical property of spinal column to change, and may further cause or quicken to close on the degeneration of sections.Therefore, from the point of long-term development, have only the cervical intervertebral disk displacement to be only a kind of treatment cervical spondylosis efficient ways.At present, common pseudo-structure of cervical intervertebral disci is more single, often uses the monolayer column structure, and this structure can not be simulated normal cervical intervertebral disk outer layer fiber ring, the double-decker of internal layer vertebral pulp.
Summary of the invention
The objective of the invention is to overcome the shortcoming of above-mentioned prior art, a kind of double-layered bionic pseudo-structure of cervical intervertebral disci and manufacturing process thereof are provided, this manufacturing process is simple, and has good biological property and mechanical property by the cervical intervertebral disk prosthesis of this technology manufacturing.
For achieving the above object, the manufacturing process that the present invention adopts is: at first adopt CAD to make up the human intervertebral disc prototype, all be designed to the model of nucleus prosthesis and the model of fibrous ring prosthese cylindric, adopt rapid shaping to obtain the mould of fibrous ring prosthese and the mould of nucleus prosthesis, and the centre of form of the mould of the centre of form of mould of nucleus prosthesis and fibrous ring prosthese is overlapped, the base distance of the mould of the base of the mould of nucleus prosthesis and fibrous ring prosthese is 2.25mm, and the body diameter difference of the mould of fibrous ring prosthese and the mould of nucleus prosthesis is 6.88mm; With 2~2.5: 10 mass ratio adds pva powder in the boiling water, and dissolves fully to polyvinyl alcohol in the boiling water stirred in water bath and to obtain polyvinyl alcohol water solution; Under the room temperature polyvinyl alcohol water solution is injected the mould of nucleus prosthesis, freezing 12~14 hours at-15~-25 ℃, it is thawed fully, carry out repeatedly 2~4 times, take out the back under the vacuum of 0.1~0.01Mpa dry 6~8 hours, the compression modulus that guarantees nucleus prosthesis is between 1.2~1.8MPa, and water content is between 70~80%, and the polyvinyl alcohol that takes out molding from the mould of nucleus prosthesis obtains nucleus prosthesis; Nucleus prosthesis is fixed in the mould of fibrous ring prosthese, simultaneously L shaped fixture is fixed in the mould of fibrous ring prosthese; Be made into polyurethane solutions by 8: 1 mass ratioes with polyurethane with the corresponding consolidation liquid of polyurethane model; The mould of fibrous ring prosthese is put into polyurethane solutions, evacuation, placed 30 minutes under the vacuum of 0.01~0.0005Mpa, place under normal pressure, room temperature again and treated that polyurethane fully solidified taking-up in 12~24 hours, the compression modulus that guarantees the fibrous ring prosthese is between 3.2~5.8MPa; Take out the interior artificial intervertebral disk prosthese of mould of fibrous ring prosthese, shaping gets final product.The cervical intervertebral disk prosthesis of making according to preparation technology of the present invention comprises the cylindrical fiber ring prosthese similar to the human cervical spine outline, in the fibrous ring prosthese, be provided with the cylindrical nucleus prosthesis that overlaps with the centre of form of fibrous ring prosthese, the base distance of the base of nucleus prosthesis and fibrous ring prosthese is 2.25mm, the body diameter difference of fibrous ring prosthese and nucleus prosthesis is 6.88mm, also is provided with a L shaped fixture on the fibrous ring prosthese.
The present invention introduces the polyvinyl alcohol permeable material and makes cervical intervertebral disk prosthesis internal layer nucleus prosthesis, the polyethylene permeable material has the elastic modelling quantity similar to natural vertebral pulp, and water permeable and water-soluble substances (for example nutrient, metabolite etc.), have well glutinous-elasticity matter and shape memory function simultaneously, even after dehydration, also can be rehydrated and do not change the character of material, and select at the material of cervical intervertebral disk prosthesis outer layer fiber ring prosthese, adopt highly elastic materials such as polyurethane.The cervical intervertebral disk prosthesis of making according to manufacturing process of the present invention can substitute cervical intervertebral disk fully, by in conjunction with the anti-technology such as ask of CT, can design the mould with personal feature, with the requirement of the individuation human intervertebral disc that satisfies different sufferers.
Description of drawings
Fig. 1 is an overall structure sketch map of the present invention;
Fig. 2 is the A-A cutaway view of Fig. 1.
The specific embodiment
Below in conjunction with accompanying drawing the present invention is described in further detail.
Embodiment 1: referring to Fig. 1,2, the present invention at first adopts CAD to make up the human intervertebral disc prototype, all be designed to the model of nucleus prosthesis 2 and the model of fibrous ring prosthese 1 cylindric, adopt rapid shaping to obtain the mould of fibrous ring prosthese 1 and the mould of nucleus prosthesis 2, and the centre of form of the mould of the centre of form of mould of nucleus prosthesis 2 and fibrous ring prosthese 1 is overlapped, the base distance of the mould of the base of the mould of nucleus prosthesis 2 and fibrous ring prosthese 1 is 2.25mm, and the body diameter difference of the mould of the mould of fibrous ring prosthese 1 and nucleus prosthesis 2 is 6.88mm; Mass ratio with 2: 10 adds pva powder in the boiling water, and dissolves fully to polyvinyl alcohol in the boiling water stirred in water bath and to obtain polyvinyl alcohol water solution; Under the room temperature polyvinyl alcohol water solution is injected the mould of nucleus prosthesis 2, freezing 12 hours at-15 ℃, it is thawed fully, carry out repeatedly 2 times, take out the back under the vacuum of 0.1Mpa dry 8 hours, the compression modulus that guarantees nucleus prosthesis 2 is between 1.2MPa, and water content is between 70%, and the polyvinyl alcohol that takes out molding from the mould of nucleus prosthesis 2 obtains nucleus prosthesis 2; Nucleus prosthesis 2 is fixed in the mould of fibrous ring prosthese 1, simultaneously L shaped fixture 3 is fixed in the mould of fibrous ring prosthese 1; Be made into polyurethane solutions by 8: 1 mass ratioes with polyurethane with the corresponding consolidation liquid of polyurethane model; The mould of fibrous ring prosthese 1 is put into polyurethane solutions, evacuation, placed 30 minutes under the vacuum of 0.0005Mpa, place under normal pressure, room temperature again and treated that polyurethane fully solidified taking-up in 12 hours, the compression modulus that guarantees fibrous ring prosthese 1 is between 5.8MPa; Take out the interior artificial intervertebral disk prosthese of mould of fibrous ring prosthese 1, shaping gets final product.The cervical intervertebral disk prosthesis that makes according to manufacturing process of the present invention comprises the cylindrical fiber ring prosthese 1 similar to the human cervical spine outline, in fibrous ring prosthese 1, be provided with the cylindrical nucleus prosthesis 2 that overlaps with the centre of form of fibrous ring prosthese 1, the base distance of the base of nucleus prosthesis 2 and fibrous ring prosthese 1 is 2.25mm, fibrous ring prosthese 1 is 6.88mm with the body diameter difference of nucleus prosthesis 2, also is provided with a L shaped fixture 3 on the fibrous ring prosthese 1.
Embodiment 2: at first adopt CAD to make up the human intervertebral disc prototype, all be designed to the model of nucleus prosthesis 2 and the model of fibrous ring prosthese 1 cylindric, adopt rapid shaping to obtain the mould of fibrous ring prosthese 1 and the mould of nucleus prosthesis 2, and the centre of form of the mould of the centre of form of mould of nucleus prosthesis 2 and fibrous ring prosthese 1 is overlapped, the base distance of the mould of the base of the mould of nucleus prosthesis 2 and fibrous ring prosthese 1 is 2.25mm, and the body diameter difference of the mould of the mould of fibrous ring prosthese 1 and nucleus prosthesis 2 is 6.88mm; Mass ratio with 2.3: 10 adds pva powder in the boiling water, and dissolves fully to polyvinyl alcohol in the boiling water stirred in water bath and to obtain polyvinyl alcohol water solution; Under the room temperature polyvinyl alcohol water solution is injected the mould of nucleus prosthesis 2, freezing 13 hours at-20 ℃, it is thawed fully, carry out repeatedly 4 times, take out the back under the vacuum of 0.01Mpa dry 6 hours, the compression modulus that guarantees nucleus prosthesis 2 is between 1.5MPa, and water content is between 78%, and the polyvinyl alcohol that takes out molding from the mould of nucleus prosthesis 2 obtains nucleus prosthesis 2; Nucleus prosthesis 2 is fixed in the mould of fibrous ring prosthese 1, simultaneously L shaped fixture 3 is fixed in the mould of fibrous ring prosthese 1; Be made into polyurethane solutions by 8: 1 mass ratioes with polyurethane with the corresponding consolidation liquid of polyurethane model; The mould of fibrous ring prosthese 1 is put into polyurethane solutions, evacuation, placed 30 minutes under the vacuum of 0.0008Mpa, place under normal pressure, room temperature again and treated that polyurethane fully solidified taking-up in 20 hours, the compression modulus that guarantees fibrous ring prosthese 1 is between 4.6MPa; Take out the interior artificial intervertebral disk prosthese of mould of fibrous ring prosthese 1, shaping gets final product.
Embodiment 3: at first adopt CAD to make up the human intervertebral disc prototype, all be designed to the model of nucleus prosthesis 2 and the model of fibrous ring prosthese 1 cylindric, adopt rapid shaping to obtain the mould of fibrous ring prosthese 1 and the mould of nucleus prosthesis 2, and the centre of form of the mould of the centre of form of mould of nucleus prosthesis 2 and fibrous ring prosthese 1 is overlapped, the base distance of the mould of the base of the mould of nucleus prosthesis 2 and fibrous ring prosthese 1 is 2.25mm, and the body diameter difference of the mould of the mould of fibrous ring prosthese 1 and nucleus prosthesis 2 is 6.88mm; Mass ratio with 2.1: 10 adds pva powder in the boiling water, and dissolves fully to polyvinyl alcohol in the boiling water stirred in water bath and to obtain polyvinyl alcohol water solution; Under the room temperature polyvinyl alcohol water solution is injected the mould of nucleus prosthesis 2, freezing 14 hours at-18 ℃, it is thawed fully, carry out repeatedly 3 times, take out the back under the vacuum of 0.05Mpa dry 7 hours, the compression modulus that guarantees nucleus prosthesis 2 is between 1.8MPa, and water content is between 75%, and the polyvinyl alcohol that takes out molding from the mould of nucleus prosthesis 2 obtains nucleus prosthesis 2; Nucleus prosthesis 2 is fixed in the mould of fibrous ring prosthese 1, simultaneously L shaped fixture 3 is fixed in the mould of fibrous ring prosthese 1; Be made into polyurethane solutions by 8: 1 mass ratioes with polyurethane with the corresponding consolidation liquid of polyurethane model; The mould of fibrous ring prosthese 1 is put into polyurethane solutions, and evacuation was placed 30 minutes under the vacuum of 0.002Mpa, placed under normal pressure, room temperature again and treated that polyurethane fully solidified taking-up in 18 hours, guaranteed that fibrous ring prosthese 1 compression modulus is between 3.2MPa; Take out the interior artificial intervertebral disk prosthese of mould of fibrous ring prosthese 1, shaping gets final product.
Embodiment 4: at first adopt CAD to make up the human intervertebral disc prototype, all be designed to the model of nucleus prosthesis 2 and the model of fibrous ring prosthese 1 cylindric, adopt rapid shaping to obtain the mould of fibrous ring prosthese 1 and the mould of nucleus prosthesis 2, and the centre of form of the mould of the centre of form of mould of nucleus prosthesis 2 and fibrous ring prosthese 1 is overlapped, the base distance of the mould of the base of the mould of nucleus prosthesis 2 and fibrous ring prosthese 1 is 2.25mm, and the body diameter difference of the mould of the mould of fibrous ring prosthese 1 and nucleus prosthesis 2 is 6.88mm; Mass ratio with 2.4: 10 adds pva powder in the boiling water, and dissolves fully to polyvinyl alcohol in the boiling water stirred in water bath and to obtain polyvinyl alcohol water solution; Under the room temperature polyvinyl alcohol water solution is injected the mould of nucleus prosthesis 2, freezing 13 hours at-25 ℃, it is thawed fully, carry out repeatedly 4 times, take out the back under the vacuum of 0.08Mpa dry 6 hours, the compression modulus that guarantees nucleus prosthesis 2 is between 1.3MPa, and water content is between 80%, and the polyvinyl alcohol that takes out molding from the mould of nucleus prosthesis 2 obtains nucleus prosthesis 2; Nucleus prosthesis 2 is fixed in the mould of fibrous ring prosthese 1, simultaneously L shaped fixture 3 is fixed in the mould of fibrous ring prosthese 1; Be made into polyurethane solutions by 8: 1 mass ratioes with polyurethane with the corresponding consolidation liquid of polyurethane model; The fibrous ring mould is put into polyurethane solutions, and evacuation was placed 30 minutes under the vacuum of 0.008Mpa, placed under normal pressure, room temperature again and treated that polyurethane fully solidified taking-up in 14 hours, and the compression modulus that guarantees fibrous ring prosthese 1 is between 3.7MPa; Take out the interior artificial intervertebral disk prosthese of mould of fibrous ring prosthese 1, shaping gets final product.
Embodiment 5: at first adopt CAD to make up the human intervertebral disc prototype, be the model of nucleus prosthesis 2 and the model of fibrous ring prosthese 1 cylindric, adopt rapid shaping to obtain the mould of fibrous ring prosthese 1 and the mould of nucleus prosthesis 2, and the centre of form of the mould of the centre of form of mould of nucleus prosthesis 2 and fibrous ring prosthese 1 is overlapped, the base distance of the mould of the base of the mould of nucleus prosthesis 2 and fibrous ring prosthese 1 is 2.25mm, and the body diameter difference of the mould of the mould of fibrous ring prosthese 1 and nucleus prosthesis 2 is 6.88mm; Mass ratio with 2.2: 10 adds pva powder in the boiling water, and dissolves fully to polyvinyl alcohol in the boiling water stirred in water bath and to obtain polyvinyl alcohol water solution; Under the room temperature polyvinyl alcohol water solution is injected the mould of nucleus prosthesis 2, freezing 12 hours at-23 ℃, it is thawed fully, carry out repeatedly 3 times, take out the back under the vacuum of 0.03Mpa dry 8 hours, the compression modulus that guarantees nucleus prosthesis 2 is between 1.6MPa, and water content is between 72%, and the polyvinyl alcohol that takes out molding from the mould of nucleus prosthesis 2 obtains nucleus prosthesis 2; Nucleus prosthesis 2 is fixed in the mould of fibrous ring prosthese 1, simultaneously L shaped fixture 3 is fixed in the mould of fibrous ring prosthese 1; Be made into polyurethane solutions by 8: 1 mass ratioes with polyurethane with the corresponding consolidation liquid of polyurethane model; The mould of fibrous ring prosthese 1 is put into polyurethane solutions, evacuation, placed 30 minutes under the vacuum of 0.005Mpa, place under normal pressure, room temperature again and treated that polyurethane fully solidified taking-up in 22 hours, the compression modulus that guarantees fibrous ring prosthese 1 is between 4.0MPa; Take out the interior artificial intervertebral disk prosthese of mould of fibrous ring prosthese 1, shaping gets final product.
Embodiment 6: at first adopt CAD to make up the human intervertebral disc prototype, all be designed to the model of nucleus prosthesis 2 and the model of fibrous ring prosthese 1 cylindric, adopt rapid shaping to obtain the mould of fibrous ring prosthese 1 and the mould of nucleus prosthesis 2, and the centre of form of the mould of the centre of form of mould of nucleus prosthesis 2 and fibrous ring prosthese 1 is overlapped, the base distance of the mould of the base of the mould of nucleus prosthesis 2 and fibrous ring prosthese 1 is 2.25mm, and the body diameter difference of the mould of the mould of fibrous ring prosthese 1 and nucleus prosthesis 2 is 6.88mm; Mass ratio with 2.5: 10 adds pva powder in the boiling water, and dissolves fully to polyvinyl alcohol in the boiling water stirred in water bath and to obtain polyvinyl alcohol water solution; Under the room temperature polyvinyl alcohol water solution is injected the mould of nucleus prosthesis 2, freezing 14 hours at-17 ℃, it is thawed fully, carry out repeatedly 2 times, take out the back under the vacuum of 0.07Mpa dry 7 hours, the compression modulus that guarantees nucleus prosthesis 2 is between 1.5MPa, and water content is between 76%, and the polyvinyl alcohol that takes out molding from the mould of nucleus prosthesis 2 obtains nucleus prosthesis 2; Nucleus prosthesis 2 is fixed in the mould of fibrous ring prosthese 1, simultaneously L shaped fixture 3 is fixed in the mould of fibrous ring prosthese 1; Be made into polyurethane solutions by 8: 1 mass ratioes with polyurethane with the corresponding consolidation liquid of polyurethane model; The mould of fibrous ring prosthese 1 is put into polyurethane solutions, and evacuation was placed 30 minutes under the vacuum of 0.01Mpa, placed under normal pressure, room temperature again and treated that polyurethane fully solidified taking-up in 24 hours, and the compression modulus that guarantees fibrous ring prosthese 1 is between 5.5MPa; Take out the interior artificial intervertebral disk prosthese of mould of fibrous ring prosthese 1, shaping gets final product.
Claims (9)
1, a kind of double-layer bionic cervical intervertebral disk prosthesis, comprise the cylindrical fiber ring prosthese (1) similar to the human cervical spine outline, it is characterized in that: in fibrous ring prosthese (1), be provided with the cylindrical nucleus prosthesis (2) that overlaps with the centre of form of fibrous ring prosthese (1), the base distance of the base of nucleus prosthesis (2) and fibrous ring prosthese (1) is 2.25mm, and fibrous ring prosthese (1) is 6.88mm with the body diameter difference of nucleus prosthesis (2).
2, double-layer bionic cervical intervertebral disk prosthesis according to claim 1 is characterized in that: also be provided with a L shaped fixture (3) on the said fibrous ring prosthese (1).
3, a kind of manufacture method of double-layer bionic cervical intervertebral disk prosthesis is characterized in that:
1) at first adopt CAD to make up the human intervertebral disc prototype, all be designed to the model of nucleus prosthesis (2) and the model of fibrous ring prosthese (1) cylindric, adopt rapid shaping technique to obtain the mould of fibrous ring prosthese (1) and the mould of nucleus prosthesis (2), and the centre of form of the mould of the centre of form of mould of nucleus prosthesis (2) and fibrous ring prosthese (1) is overlapped, the base distance of the mould of the base of the mould of nucleus prosthesis (2) and fibrous ring prosthese (1) is 2.25mm, and the body diameter difference of the mould of the mould of fibrous ring prosthese (1) and nucleus prosthesis (2) is 6.88mm;
2) with 2~2.5: 10 mass ratio adds pva powder in the boiling water, and dissolves fully to polyvinyl alcohol in the boiling water stirred in water bath and to obtain polyvinyl alcohol water solution;
3) under the room temperature polyvinyl alcohol water solution is injected the mould of nucleus prosthesis 2, freezing 12~14 hours at-15~-25 ℃, it is thawed fully, carry out repeatedly 2~4 times, take out the back under the vacuum of 0.1~0.01Mpa dry 6~8 hours, the compression modulus that guarantees nucleus prosthesis (2) is between 1.2~1.8MPa, and water content is between 70~80%, and the polyvinyl alcohol that takes out molding from the mould of nucleus prosthesis (2) obtains nucleus prosthesis (2);
4) nucleus prosthesis 2 is fixed in the mould of fibrous ring prosthese (1), simultaneously L shaped fixture (3) is fixed in the mould of fibrous ring prosthese (1);
5) be made into polyurethane solutions by 8: 1 mass ratio with polyurethane with the corresponding consolidation liquid of polyurethane model;
6) mould of fibrous ring prosthese (1) is put into polyurethane solutions, evacuation, under the vacuum of 0.01~0.0005Mpa, placed 30 minutes, place under normal pressure, room temperature again and treated that polyurethane fully solidified taking-up in 12~24 hours, the compression modulus that guarantees fibrous ring prosthese (1) is between 3.2~5.8MPa;
7) the artificial intervertebral disk prosthese in the mould of taking-up fibrous ring prosthese (1), shaping gets final product.
4, the manufacture method of double-layer bionic cervical intervertebral disk prosthesis according to claim 3, it is characterized in that: at first adopt CAD to make up the human intervertebral disc prototype, all be designed to the model of nucleus prosthesis (2) and the model of fibrous ring prosthese (1) cylindric, adopt rapid shaping technique to obtain the mould of fibrous ring prosthese (1) and the mould of nucleus prosthesis (2), and the centre of form of the mould of the centre of form of mould of nucleus prosthesis (2) and fibrous ring prosthese (1) is overlapped, the base distance of the mould of the base of the mould of nucleus prosthesis (2) and fibrous ring prosthese (1) is 2.25mm, and the body diameter difference of the mould of the mould of fibrous ring prosthese (1) and nucleus prosthesis (2) is 6.88mm; Mass ratio with 2: 10 adds pva powder in the boiling water, and dissolves fully to polyvinyl alcohol in the boiling water stirred in water bath and to obtain polyvinyl alcohol water solution; Under the room temperature polyvinyl alcohol water solution is injected the mould of nucleus prosthesis (2), freezing 12 hours at-15 ℃, it is thawed fully, carry out repeatedly 2 times, take out the back under the vacuum of 0.1Mpa dry 8 hours, the compression modulus that guarantees nucleus prosthesis (2) is at 1.2MPa, and water content is 70%, and the polyvinyl alcohol that takes out molding from the mould of nucleus prosthesis (2) obtains nucleus prosthesis (2); Nucleus prosthesis (2) is fixed in the mould of fibrous ring prosthese (1), simultaneously L shaped fixture (3) is fixed in the mould of fibrous ring prosthese (1); Be made into polyurethane solutions by 8: 1 mass ratioes with polyurethane with the corresponding consolidation liquid of polyurethane model; The mould of fibrous ring prosthese (1) is put into polyurethane solutions, evacuation, placed 30 minutes under the vacuum of 0.0005Mpa, place under normal pressure, room temperature again and treated that polyurethane fully solidified taking-up in 12 hours, the compression modulus that guarantees fibrous ring prosthese (1) is at 5.8MPa; Take out the interior artificial intervertebral disk prosthese of mould of fibrous ring prosthese (1), shaping gets final product.
5, the manufacture method of double-layer bionic cervical intervertebral disk prosthesis according to claim 3, it is characterized in that: at first adopt CAD to make up the human intervertebral disc prototype, all be designed to the model of nucleus prosthesis (2) and the model of fibrous ring prosthese (1) cylindric, adopt rapid shaping technique to obtain the mould of fibrous ring prosthese (1) and the mould of nucleus prosthesis (2), and the centre of form of the mould of the centre of form of mould of nucleus prosthesis (2) and fibrous ring prosthese (1) is overlapped, the base distance of the mould of the base of the mould of nucleus prosthesis (2) and fibrous ring prosthese (1) is 2.25mm, and the body diameter difference of the mould of the mould of fibrous ring prosthese (1) and nucleus prosthesis (2) is 6.88mm; Mass ratio with 2.3: 10 adds pva powder in the boiling water, and dissolves fully to polyvinyl alcohol in the boiling water stirred in water bath and to obtain polyvinyl alcohol water solution; Under the room temperature polyvinyl alcohol water solution is injected the mould of nucleus prosthesis (2), freezing 13 hours at-20 ℃, it is thawed fully, carry out repeatedly 4 times, take out the back under the vacuum of 0.01Mpa dry 6 hours, the compression modulus that guarantees nucleus prosthesis (2) is at 1.5MPa, and water content is 78%, and the polyvinyl alcohol that takes out molding from the mould of nucleus prosthesis (2) obtains nucleus prosthesis (2); Nucleus prosthesis (2) is fixed in the mould of fibrous ring prosthese (1), simultaneously L shaped fixture (3) is fixed in the mould of fibrous ring prosthese (1); Be made into polyurethane solutions by 8: 1 mass ratioes with polyurethane with the corresponding consolidation liquid of polyurethane model; The mould of fibrous ring prosthese (1) is put into polyurethane solutions, evacuation, placed 30 minutes under the vacuum of 0.0008Mpa, place under normal pressure, room temperature again and treated that polyurethane fully solidified taking-up in 20 hours, the compression modulus that guarantees fibrous ring prosthese (1) is at 4.6MPa; Take out the interior artificial intervertebral disk prosthese of mould of fibrous ring prosthese (1), shaping gets final product.
6, the manufacture method of double-layer bionic cervical intervertebral disk prosthesis according to claim 3, it is characterized in that: at first adopt CAD to make up the human intervertebral disc prototype, all be designed to the model of nucleus prosthesis (2) and the model of fibrous ring prosthese (1) cylindric, adopt rapid shaping technique to obtain the mould of fibrous ring prosthese (1) and the mould of nucleus prosthesis (2), and the centre of form of the mould of the centre of form of mould of nucleus prosthesis (2) and fibrous ring prosthese (1) is overlapped, the base distance of the mould of the base of the mould of nucleus prosthesis (2) and fibrous ring prosthese (1) is 2.25mm, and the body diameter difference of the mould of the mould of fibrous ring prosthese (1) and nucleus prosthesis (2) is 6.88mm; With 2.1; 10 mass ratio adds pva powder in the boiling water, and dissolves fully to polyvinyl alcohol in the boiling water stirred in water bath and to obtain polyvinyl alcohol water solution; Under the room temperature polyvinyl alcohol water solution is injected the mould of nucleus prosthesis (2), freezing 14 hours at-18 ℃, it is thawed fully, carry out repeatedly 3 times, take out the back under the vacuum of 0.05Mpa dry 7 hours, the compression modulus that guarantees nucleus prosthesis (2) is at 1.8MPa, and water content is 75%, and the polyvinyl alcohol that takes out molding from the mould of nucleus prosthesis (2) obtains nucleus prosthesis (2); Nucleus prosthesis (2) is fixed in the mould of fibrous ring prosthese (1), simultaneously L shaped fixture (3) is fixed in the mould of fibrous ring prosthese (1); Be made into polyurethane solutions by 8: 1 mass ratioes with polyurethane with the corresponding consolidation liquid of polyurethane model; The mould of fibrous ring prosthese (1) is put into polyurethane solutions, evacuation, under the vacuum of 0.002Mpa, placed 30 minutes, under normal pressure, room temperature, place again and treated that polyurethane fully solidified taking-up in 18 hours, guarantee that fibrous ring prosthese (1) compression modulus is at 3.2MPa; Take out the interior artificial intervertebral disk prosthese of mould of fibrous ring prosthese (1), shaping gets final product.
7, the manufacture method of double-layer bionic cervical intervertebral disk prosthesis according to claim 3, it is characterized in that: at first adopt CAD to make up the human intervertebral disc prototype, all be designed to the model of nucleus prosthesis (2) and the model of fibrous ring prosthese (1) cylindric, adopt rapid shaping technique to obtain the mould of fibrous ring prosthese (1) and the mould of nucleus prosthesis (2), and the centre of form of the mould of the centre of form of mould of nucleus prosthesis (2) and fibrous ring prosthese (1) is overlapped, the base distance of the mould of the base of the mould of nucleus prosthesis (2) and fibrous ring prosthese (1) is 2.25mm, and the body diameter difference of the mould of the mould of fibrous ring prosthese (1) and nucleus prosthesis (2) is 6.88mm; Mass ratio with 2.4: 10 adds pva powder in the boiling water, and dissolves fully to polyvinyl alcohol in the boiling water stirred in water bath and to obtain polyvinyl alcohol water solution; Under the room temperature polyvinyl alcohol water solution is injected the mould of nucleus prosthesis (2), freezing 13 hours at-25 ℃, it is thawed fully, carry out repeatedly 4 times, take out the back under the vacuum of 0.08Mpa dry 6 hours, the compression modulus that guarantees nucleus prosthesis (2) is at 1.3MPa, and water content is 80%, and the polyvinyl alcohol that takes out molding from the mould of nucleus prosthesis (2) obtains nucleus prosthesis (2); Nucleus prosthesis (2) is fixed in the mould of fibrous ring prosthese (1), simultaneously L shaped fixture (3) is fixed in the mould of fibrous ring prosthese (1); Be made into polyurethane solutions by 8: 1 mass ratioes with polyurethane with the corresponding consolidation liquid of polyurethane model; The mould of fibrous ring prosthese (1) is put into polyurethane solutions, evacuation, placed 30 minutes under the vacuum of 0.008Mpa, place under normal pressure, room temperature again and treated that polyurethane fully solidified taking-up in 14 hours, the compression modulus that guarantees fibrous ring prosthese (1) is at 3.7MPa; Take out the interior artificial intervertebral disk prosthese of mould of fibrous ring prosthese (1), shaping gets final product.
8, the manufacture method of double-layer bionic cervical intervertebral disk prosthesis according to claim 3, it is characterized in that: at first adopt CAD to make up the human intervertebral disc prototype, be the model of nucleus prosthesis (2) and the model of fibrous ring prosthese (1) cylindric, adopt rapid shaping technique to obtain the mould of fibrous ring prosthese (1) and the mould of nucleus prosthesis (2), and the centre of form of the mould of the centre of form of mould of nucleus prosthesis (2) and fibrous ring prosthese (1) is overlapped, the base distance of the mould of the base of the mould of nucleus prosthesis (2) and fibrous ring prosthese (1) is 2.25mm, and the body diameter difference of the mould of the mould of fibrous ring prosthese (1) and nucleus prosthesis (2) is 6.88mm; Mass ratio with 2.2: 10 adds pva powder in the boiling water, and dissolves fully to polyvinyl alcohol in the boiling water stirred in water bath and to obtain polyvinyl alcohol water solution; Under the room temperature polyvinyl alcohol water solution is injected the mould of nucleus prosthesis (2), freezing 12 hours at-23 ℃, it is thawed fully, carry out repeatedly 3 times, take out the back under the vacuum of 0.03Mpa dry 8 hours, the compression modulus that guarantees nucleus prosthesis (2) is at 1.6MPa, and water content is 72%, and the polyvinyl alcohol that takes out molding from the mould of nucleus prosthesis (2) obtains nucleus prosthesis (2); Nucleus prosthesis (2) is fixed in the mould of fibrous ring prosthese (1), simultaneously L shaped fixture (3) is fixed in the mould of fibrous ring prosthese (1); Be made into polyurethane solutions by 8: 1 mass ratioes with polyurethane with the corresponding consolidation liquid of polyurethane model; The mould of fibrous ring prosthese (1) is put into polyurethane solutions, evacuation, placed 30 minutes under the vacuum of 0.005Mpa, place under normal pressure, room temperature again and treated that polyurethane fully solidified taking-up in 22 hours, the compression modulus that guarantees fibrous ring prosthese (1) is at 4.0MPa; Take out the interior artificial intervertebral disk prosthese of mould of fibrous ring prosthese (1), shaping gets final product.
9, the manufacture method of double-layer bionic cervical intervertebral disk prosthesis according to claim 3, it is characterized in that: at first adopt CAD to make up the human intervertebral disc prototype, all be designed to the model of nucleus prosthesis (2) and the model of fibrous ring prosthese (1) cylindric, adopt rapid shaping technique to obtain the mould of fibrous ring prosthese (1) and the mould of nucleus prosthesis (2), and the centre of form of the mould of the centre of form of mould of nucleus prosthesis (2) and fibrous ring prosthese (1) is overlapped, the base distance of the mould of the base of the mould of nucleus prosthesis 2 and fibrous ring prosthese (1) is 2.25mm, and the body diameter difference of the mould of the mould of fibrous ring prosthese (1) and nucleus prosthesis (2) is 6.88mm; Mass ratio with 2.5: 10 adds pva powder in the boiling water, and dissolves fully to polyvinyl alcohol in the boiling water stirred in water bath and to obtain polyvinyl alcohol water solution; Under the room temperature polyvinyl alcohol water solution is injected the mould of nucleus prosthesis (2), freezing 14 hours at-17 ℃, it is thawed fully, carry out repeatedly 2 times, take out the back under the vacuum of 0.07Mpa dry 7 hours, the compression modulus that guarantees nucleus prosthesis (2) is at 1.5MPa, and water content is 76%, and the polyvinyl alcohol that takes out molding from the mould of nucleus prosthesis (2) obtains nucleus prosthesis (2); Nucleus prosthesis (2) is fixed in the mould of fibrous ring prosthese (1), simultaneously L shaped fixture (3) is fixed in the mould of fibrous ring prosthese (1); Be made into polyurethane solutions by 8: 1 mass ratioes with polyurethane with the corresponding consolidation liquid of polyurethane model; The mould of fibrous ring prosthese (1) is put into polyurethane solutions, evacuation, placed 30 minutes under the vacuum of 0.01Mpa, place under normal pressure, room temperature again and treated that polyurethane fully solidified taking-up in 24 hours, the compression modulus that guarantees fibrous ring prosthese (1) is at 5.5MPa; Take out the interior artificial intervertebral disk prosthese of mould of fibrous ring prosthese (1), shaping gets final product.
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US10675158B2 (en) | 2015-12-16 | 2020-06-09 | Nuvasive, Inc. | Porous spinal fusion implant |
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CN101874902B (en) * | 2009-06-19 | 2013-04-03 | 清华大学 | Method for preparing artificial nucleus pulposus prosthetic material |
CN103099689B (en) * | 2013-02-19 | 2015-08-26 | 哈尔滨朝阳滨辉实业发展集团有限公司 | The Minimally Invasive Surgery preparation method of spiral nucleus prosthesis and application |
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CN107496060A (en) * | 2017-08-09 | 2017-12-22 | 国家纳米科学中心 | A kind of three-dimensional artificial total spinal disc and its preparation method and application |
CN112826986B (en) * | 2020-12-31 | 2022-12-06 | 中国人民解放军空军军医大学 | Hydrogel artificial cervical intervertebral disc based on stent reinforcement and preparation method thereof |
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CN2288707Y (en) * | 1997-03-05 | 1998-08-26 | 鲁继武 | Artificial intervertebral disc |
CN2544699Y (en) * | 2002-04-25 | 2003-04-16 | 沈强 | Improved human cervical intervertebral disc prosthesis |
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US5545229A (en) * | 1988-08-18 | 1996-08-13 | University Of Medicine And Dentistry Of Nj | Functional and biocompatible intervertebral disc spacer containing elastomeric material of varying hardness |
CN2288707Y (en) * | 1997-03-05 | 1998-08-26 | 鲁继武 | Artificial intervertebral disc |
CN2544699Y (en) * | 2002-04-25 | 2003-04-16 | 沈强 | Improved human cervical intervertebral disc prosthesis |
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US10675158B2 (en) | 2015-12-16 | 2020-06-09 | Nuvasive, Inc. | Porous spinal fusion implant |
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