CN202069721U - Integrally-woven artificial lumbar intervertebral prothesis of hard end plates and soft nucleus pulposus - Google Patents
Integrally-woven artificial lumbar intervertebral prothesis of hard end plates and soft nucleus pulposus Download PDFInfo
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- CN202069721U CN202069721U CN2009200357973U CN200920035797U CN202069721U CN 202069721 U CN202069721 U CN 202069721U CN 2009200357973 U CN2009200357973 U CN 2009200357973U CN 200920035797 U CN200920035797 U CN 200920035797U CN 202069721 U CN202069721 U CN 202069721U
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- soleplate
- elastic
- end plate
- elastic core
- fiber bundle
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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
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- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Neurology (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
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- General Health & Medical Sciences (AREA)
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- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The utility model provides a novel integral artificial lumbar intervertebral prothesis which belongs to a medical human body implant and is used for treating lumbar vertebra degenerative diseases. The prothesis is of an integral structure and consists of an upper end plate, a lower end plate, an elastic core, an elastic fiber bundle net and a polymer washer, wherein the upper end plate and the lower end plate are made of titanium, and the elastic core, the elastic fiber bundle net and the polymer washer are made of medical high molecular materials; the elastic core is of a structure which is clamped between the upper end plate and the lower end plate and performs an elastic support function, the elastic core is designed into a shape which is similar to the nucleus pulposus structure, and the elastic core has support property and the characteristic of load elastic buffering; as the upper end plate and the lower end plate are made of titanium, magnetic resonance imaging is not influenced, images can be developed under X rays, the shapes are made according to the end plates of the physiological intervertebral disc, anchoring points are arranged for the convenience of the weaving of fiber bundles, and the spraying of hydroxyapatite and the arrangement of a keel are favorable to the growing-in of bones and the stabilization of the prothesis; the woven fiber bundle net is anchored on the end plates and woven outside the elastic core, the fiber bundle net performs a function for connecting all parts into a whole, and the inclined angle of the fiber bundle net with the plane is arranged into an acute angle of 20 degrees to 40 degrees so as to suit the inclined angle of the fiber bundles of the intervertebral disc of the human body and the end plates; and the polymer washer is wrapped outside the outer layer of the fiber bundles for preventing the growing-in of soft tissues and wrapping chips, so that the biocompatibility is improved. Under ideal conditions.
Description
Technical field:
The present invention relates to a kind of novel artificial lumbar disc prostheses, belong to being implanted into property of medical human orthopaedics internal fixation medical apparatus and instruments.Can be used for light, the moderate regression of lumbar vertebra, intervertebral disc source property lumbago, prolapse of lumbar intervertebral disc, light moderate neurogenic intermittent claudication, the regression of merging the back adjacent discs, the discectomy of L5 sacrumization, the treatment of isolated Modic I pathological changes.
Background technology:
(Lumbar degenerative disease LDD) is one of human disease of seeing at most to the degenerative lumbar disease always, and the people of U.S. Hult statistics 80% can be subjected to the LDD puzzlement in life.It is lumbago and skelalgia due to the LDD that the activity below 45 years old of NCHS report limits modal factor, and the expense that is used for the LDD treatment every year reaches hundreds of millions dollars, does not also comprise the loss that absence from work without reason causes.In China, need annual 1 example of general per 1000 people of patient of operation, calculate that sickness rate is annual 1-2%, along with China enters aging society, its sickness rate will be higher.
The early stage performance of LDD is often just because the lumbago due to disorder of intervertebral disc internal structure or the degenerative disc pathological changes; Along with vertebral body hyperosteogeny, zygapophysial joints regression and hypertrophy of ligamentum flavum etc. can further appear in disease progression, so cause that unstable spine is fixed, lumbar spondylolisthesis, lumbar spinal stenosis, thereby mechanicalness flank pain, lumbar spinal stenosis appear.
At present this treatment of diseases is mainly selected operative treatment when expectant treatment is invalid.The operation mainly be intervertebral disc marrow nuclear excising, laminectomy for decompression add bone-graft fusion and (or) internal fixation.But present puzzlement is not improve through the clinical improvement rate of the postoperative of above operative treatment, and Gibson JN etc. sum up the statistics of the perspective randomized controlled trial of Cochrane data base, finds that the raising that is fused into power does not cause the corresponding raising of lumbago and backache clinical improvements rate; Fritzell P etc. thinks not have significant difference between different fusion methods, and uses the painless phase of fusion postoperative of internal fixation to be shorter than the operation of not using internal fixation on the contrary.Present viewpoint thinks that its reason mainly is that strong internal fixation and fusion destroyed lumbar vertebra biomechanics environment, the transmission that causes loading does not meet physiological conditions, and to cause sagittal plane unbalance, can further cause stress shielding to cause loosening, the fatigue break etc. that the bone amount reduces, closes on sections facet joint regression acceleration, internal fixation thus.
Therefore the proposition of non-integration fixed conception has been arranged in recent years.Non-integration fixedly is to change the range of activity of lumbar vertebra motion segment and a kind of fixed form that load does not but merge, ideal non-integration is fixing can to keep useful activity, and stop the algesiogenic direction of motion and plane of movement, physiological load transmits between reservation paragraph, thereby can alleviating pain and prevent the neighbouring section regression.The fixed kind of non-integration is more, comprises fixed system between spinous process, the dynamic property fixed system of pedicle, pedicle nail semi-rigid metal fixed system, artificial intervertebral disc system, zygapophysial joints exchange system.
Wherein, artificial intervertebral disc is considered to one of important development direction for the treatment of degenerative lumbar: 1. excised the disc tissue of pathological changes fully, eliminated the mechanicalness lumbago and backache that intervertebral disc disorder itself causes; 2. removed of the compressing stimulation of regression intervertebral disc, can effectively remove the nerve compression symptom spinal nerves and nerve root; 3. allow the activity of operation sections, reduce the lumbar vertebra mobility of postoperative and lose; 4. it is little to lumbar vertebra biomechanics environmental effect to implant the back, and the incidence rate of neighbouring section regression is lower than traditional fusion, so but multi-segmental displacement.
Artificial lumbar disc prostheses has had multiple design abroad at present.
(1) multi-part prosthese
Multi-part prosthese (it is represented as Prodisc series prosthese and Charite prosthese) reaches the intervertebral dynamic fixing by form the Gliding joint face between each parts, is called as " articulatio intercentralis displacement apparatus ".These prostheses find that through about 5 years follow up a case by regular visits to clinical lumbago remission rate at a specified future date is generally about 50%, complication rate is about 32%, effect can't reach theory expectation mostly, not even as fusion, its reason is that the physiology intercalated disc is not interpyramidal synovial membrane diarthrosis, but deformable " fibrous cartilage connection " device, the existence of multi-part prosthese intrinsic articulation face makes it not possess the stretching hindrance function, " flexing-stress strain curve " that also just can't mate the physiology intercalated disc, this will cause the strain of rear zygapophysial joints, the former capital is no longer suitable to become ideal prosthese framework, and the emphasis of research begins to turn to the integral type prosthese framework that can reach stretch limit.
(2) integral type prosthese
The integral type prosthese as the term suggests be exactly its prosthese be the monoblock type framework, do not have prosthese intrinsic articulation face, integrate the purpose that reaches simulation physiology intervertebral disc mutually by the physical property of each component in the framework.That sees clearly report at present has Physio-L prosthese and a CAdisc-L prosthese.
1.Physio-L prosthese.Report in 2006 by Casey Lee, the many hardness elastic kernel that constitutes by the Merlon with different brackets is anchored in upper and lower titanium plate, is the effect of the rotation at center to reach the continuation of permission implantation sections with the physiology rotating shaft, and upper and lower titanium plate is provided with Os Draconis and contacts in order to the bone fusion with soleplate." load-displacement curve " of its open report is visible under the load condition of 300-600N, and the deformation of this prosthese and physiology intercalated disc coupling is good, but departs from the physiology intercalated disc gradually greater than its displacement curve of stress of 600N.May be to consider after material and process complexity increase to cause the decline of reliability in the prosthetic designs, but still not have the design limit tensile part in this scheme, so just can't reach the fibrous ring " flexing-stress strain curve " of physiology intercalated disc; There is weakness in its elastic core with the anchoring of titanium plate up and down, does not have the elastic stretching component limitations easily to fail to structure when shear load.
2.CAdisc-L prosthese.This prosthese is developed by Ranier Technology company, it is made by the Merlon polyurethane material, it is incorporate structure, paid attention to the coupling to " the flexing stress strain curve " of physiology intercalated disc, considered its moulding intensity and processing technology, soleplate does not adopt metallic plate about it, may make the upper and lower soleplate of bone and prosthese be difficult for merging like this, influence stability, and do not have the metal soleplate just can't assess the prosthese position by the X line, giving performs the operation installs, postoperative is followed up a case by regular visits to makes troubles.
The integrated prosthese that these are up-to-date, though can't obtain accurate mechanics and clinical testing data because of being in the technical know-how stage, but James J.Yue etc. are according to its disclosed data, think that both 3D dynamic mechanics parameters still can not mate the physiology intercalated disc, the performance pluses and minuses of above-mentioned two kinds of designs see Table 1.
The performance pluses and minuses of table 1.Physio-L and CAdisc-L design
In sum, develop a kind of coupling human intervertebral disc performance, simple and reliable for structure, the integrated artificial lumbar disc prostheses that China's independent intellectual property right arranged is to the degenerative lumbar treatment of diseases, to the Development of Health Service of China, all have important practical sense to building novelty country.
Summary of the invention:
In order to overcome the problems referred to above of existing integrated artificial lumbar disc prostheses, the purpose of this invention is to provide a kind of simple and reliable for structure, physical property and people's lumbar intervertebral disc are approaching, artificial lumbar disc prostheses-" the hard soleplate-soft vertebral pulp integrated weaved artificial lumbar intervertebral disc " of China's independent intellectual property right arranged, be used for the degenerative lumbar treatment of diseases.
For achieving the above object, technical scheme of the present invention is:
(1) on the material, the present invention makes elastic core with medical macromolecular materials; With macromolecular fibre Shu Jinhang braiding, make fibre bundle; The characteristics of these macromolecular materials are intensity height, low elastic modulus, and fatigue resistance, corrosion-resistant, nontoxic, high-biocompatibility.Make soleplate with titanium alloy, be characterized in high strength, low-gravity, low elastic modulus, fatigue resistance, corrosion-resistant, nontoxic, high-biocompatibility can develop under the X line, does not influence nuclear magnetic resonance.
(2) in the configuration design, the present invention is a kind of monolithic construction, rather than multicomponent structure, its building block comprises elastic core, elastic fiber bundle net and metal soleplate, simple in structure, there is not prosthese intrinsic articulation face, reduced reaction such as different materials or the direct complicated electrolysis of a plurality of element, friction in human body, so improved biocompatibility and reliability.Elastic core, for being stuck in the structure that plays the resiliency supported effect up and down between the soleplate, be characterized in: be designed to class vertebral pulp structure in shape, the transverse section size that contacts with soleplate accounts for 50% of soleplate area, so just better simulated the vertebral pulp structure of physiology intervertebral disc, characteristics with support performance and load elastic buffer have overcome the shortcoming that Physio-L " load-deformation curve " and physiology intervertebral disc are misfitted.Soleplate up and down, for up and down with the bonded position of contiguous vertebral body, be characterized in: 1. with the titanium alloy manufacturing, having overcome the Physio-L soleplate influences nuclear magnetic resonance, and the CAdisc-L soleplate is nonvisualized shortcoming under the X line; 2. make according to physiology intervertebral disc soleplate in shape; 3. on soleplate, be provided with anchor point, made things convenient for the braiding of fibre bundle, the rational range of movement of restriction elastic core; 4. spraying hydroxyapatite and design Os Draconis is beneficial to bone and grows into and stablize prosthese, has overcome the CAdisc-L soleplate and has contacted not firm shortcoming with bone.Braided fiber bundle net, for being anchored on the soleplate and weaving structure into the net outside elastic core, be characterized in: 1. the anchor point by soleplate weaves, and plays each parts is connected to whole effect; 2. do the time spent in stretching, turning moment, the elastic stretching performance of himself can be simulated the mechanical behavior of physiology annulus fibrosus disci intervertebralis, has overcome the shortcoming that Physio-L and CAdisc-L can not simulate tensile load.The polymer packing ring, prevent that at the outer parcel of fibre bundle net soft tissue from growing into and wrap up chip, be characterized in: design this structure and can prevent that soft tissue from growing into and influence the prosthese performance, simultaneously can wrap up chip and alleviate inflammatory reaction on every side, improve biocompatibility than Physio-L and CAdi sc-L, and can share certain load.The positive small incision of abdomen before ideally can doing carries out the prosthese location and installation being gone into the gap getting final product after intervertebral space prepares, and does not need the assembly unit process of multi-part prosthese complexity.
The invention has the beneficial effects as follows a kind of novel integral type artificial lumbar disc prostheses of design, when having overcome existing prosthese shortcoming, also fully carried out bionical framework optimization, the present invention is simple and reliable for structure, physical property and physiology intervertebral disc matching degree height, operation is implanted convenient, little to the human body wound, cost is low, can, moderate regression light with lumbar vertebra, intervertebral disc source property lumbago, prolapse of lumbar intervertebral disc, light moderate neurogenic intermittent claudication, merge the regression of back adjacent discs, the discectomy of L5 sacrumization, the treatment of isolated Modic I pathological changes.
Description of drawings:
The present invention is further described below in conjunction with drawings and Examples.
Fig. 1 is a three dimensional back view of the present invention.
Fig. 2 is a top view (profile) before the three-dimensional of the present invention, and wherein the polymer packing ring is broken away and can sees the fibre bundle net.
Fig. 3 is three-dimensional looking forward figure of the present invention, can see the angle of fibre bundle and horizontal plane.
Fig. 4 is three-dimensional looking forward figure of the present invention, has removed the polymer packing ring, can see fibre bundle and elastic core.
Fig. 5 is three-dimensional looking forward figure of the present invention, has removed polymer packing ring and fibre bundle net, can see elastic core.
Fig. 6 is three-dimensional looking forward figure of the present invention, has removed the partially polymerized body packing ring and the hydroxyapatite coating layer of soleplate up and down, can see that fibre bundle is woven into net by soleplate anchor point up and down.
Fig. 7 is a top view of the present invention, can see soleplate and Os Draconis.
The figure number explanation
1, goes up the Os Draconis of soleplate
2, the Os Draconis of following soleplate
3, go up soleplate
4, following soleplate
5, fibre bundle net
6, polymer packing ring
7, elastic core
8, the fibre bundle net is at the anchor point of soleplate
9, the angle of fibre bundle and soleplate
The specific embodiment:
Among Fig. 1-7,1,2 is respectively the Os Draconis of soleplate up and down, and its shape can be that cylindrical, rectangle or blade-like are inserted soleplate, plays the reinforcement soleplate and is connected with vertebral body, and surface black is a spraying hydroxyapatite coating; 3,4 be respectively upper and lower soleplate, its flat shape is consistent with the human disc soleplate, and its surface black is a spraying hydroxyapatite coating; 5 is the fibre bundle net, and adopting accurate basketry is that fulcrum weaves with the anchor hole of soleplate, and the angle of itself and horizontal plane is 30 ° ± 10 ° acute angle, with the fibre bundle of match people intervertebral disc and the angle of soleplate; 6 is the polymer packing ring, prevents that at the outer parcel of fibre bundle net soft tissue from growing into and wrap up chip; 7 is elastic core, for being stuck in the structure that plays the resiliency supported effect up and down between the soleplate, is wrapped up by the fibre bundle net; 8 is the anchor point of soleplate, by the clock direction 12 anchor holes is set on soleplate, and fibre bundle passes anchor hole and weaves; 9 is the angle of fibre bundle and soleplate, is 30 ° ± 10 ° acute angle.
Claims (4)
1. novel artificial lumbar disc prostheses, the structure that it is characterized in that artificial lumbar disc prostheses is an overall structure, by upper and lower soleplate, elastic core, the elastic fiber bundle, the polymer packing ring is formed; Its three dimensional shapes is consistent with the shape of people's lumbar intervertebral disc, and it is configured to the elastic fiber bundle and passes the circle anchor point that up and down soleplate punching forms and be woven into net, is aggregated the body packing ring around this net content elastic core, this net and wraps up.
2. artificial lumbar disc prostheses according to claim 1 it is characterized in that profile is that three-D profile is holistic, and shape is according to the shape manufacturing of human physiology intervertebral disc.
3. according to the described artificial lumbar disc prostheses of claim 1, it is characterized in that: upper and lower soleplate adopts the titanium alloy manufacturing, is provided with anchor point, has Os Draconis, up and down the outer surface spraying hydroxyapatite.
4. artificial lumbar disc prostheses according to claim 1 is characterized in that: the anchor point that weaving method passes soleplate is crossed by its fibre bundle Netcom, and then is woven into net; Its every fibre bundle and the planar angle of soleplate are 30 ° ± 10 ° acute angle.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009200357973U CN202069721U (en) | 2009-03-20 | 2009-03-20 | Integrally-woven artificial lumbar intervertebral prothesis of hard end plates and soft nucleus pulposus |
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| CN2009200357973U CN202069721U (en) | 2009-03-20 | 2009-03-20 | Integrally-woven artificial lumbar intervertebral prothesis of hard end plates and soft nucleus pulposus |
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| CN202069721U true CN202069721U (en) | 2011-12-14 |
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| CN2009200357973U Expired - Fee Related CN202069721U (en) | 2009-03-20 | 2009-03-20 | Integrally-woven artificial lumbar intervertebral prothesis of hard end plates and soft nucleus pulposus |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102579167A (en) * | 2012-01-19 | 2012-07-18 | 冠亚生技股份有限公司 | Composite-layer intervertebral restoration apparatus |
| CN106388982A (en) * | 2016-11-29 | 2017-02-15 | 河南科技大学 | Interbody fusion cage |
| CN106955174A (en) * | 2016-11-30 | 2017-07-18 | 重庆润泽医药有限公司 | A kind of elastic Invasive lumbar fusion device |
| CN110025411A (en) * | 2018-06-12 | 2019-07-19 | 深圳市立心科学有限公司 | Invasive lumbar fusion device with elastic portion |
| CN110368148A (en) * | 2019-08-05 | 2019-10-25 | 北京爱康宜诚医疗器材有限公司 | Flexible artificial intervertebral disk |
| CN112622308A (en) * | 2020-12-01 | 2021-04-09 | 北玻院(滕州)复合材料有限公司 | Carbon fiber composite material arm section and preparation method thereof |
-
2009
- 2009-03-20 CN CN2009200357973U patent/CN202069721U/en not_active Expired - Fee Related
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102579167A (en) * | 2012-01-19 | 2012-07-18 | 冠亚生技股份有限公司 | Composite-layer intervertebral restoration apparatus |
| CN106388982A (en) * | 2016-11-29 | 2017-02-15 | 河南科技大学 | Interbody fusion cage |
| CN106388982B (en) * | 2016-11-29 | 2018-10-26 | 河南科技大学 | A kind of Invasive lumbar fusion device |
| CN106955174A (en) * | 2016-11-30 | 2017-07-18 | 重庆润泽医药有限公司 | A kind of elastic Invasive lumbar fusion device |
| CN110025411A (en) * | 2018-06-12 | 2019-07-19 | 深圳市立心科学有限公司 | Invasive lumbar fusion device with elastic portion |
| CN110025411B (en) * | 2018-06-12 | 2020-09-18 | 深圳市立心科学有限公司 | Intervertebral fusion device with elastic part |
| CN110368148A (en) * | 2019-08-05 | 2019-10-25 | 北京爱康宜诚医疗器材有限公司 | Flexible artificial intervertebral disk |
| CN110368148B (en) * | 2019-08-05 | 2024-05-28 | 北京爱康宜诚医疗器材有限公司 | Flexible artificial intervertebral disc |
| CN112622308A (en) * | 2020-12-01 | 2021-04-09 | 北玻院(滕州)复合材料有限公司 | Carbon fiber composite material arm section and preparation method thereof |
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| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| C17 | Cessation of patent right | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20111214 Termination date: 20120320 |