CN102178983A - HA fiber-enhanced PEEK backbone fusion device - Google Patents
HA fiber-enhanced PEEK backbone fusion device Download PDFInfo
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- CN102178983A CN102178983A CN2011100663519A CN201110066351A CN102178983A CN 102178983 A CN102178983 A CN 102178983A CN 2011100663519 A CN2011100663519 A CN 2011100663519A CN 201110066351 A CN201110066351 A CN 201110066351A CN 102178983 A CN102178983 A CN 102178983A
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Abstract
The invention relates to a hydroxyapatite (HA) fiber-enhanced polyether-ether-ketone (PEEK) backbone fusion device, which is characterized by being manufactured by adding HA fibers into a PEEK material; the HA fibers are hydroxyapatite fibers of which the diameters are in the nanometer level and the lengths are in the micrometer level; PEEK is a medical implanted PEEK raw material; and the HA fiber-enhanced PEEK contains 5 to 30 mass parts of HA fibers, and the HA fibers can enhance the strength of the PEEK, overcome the defect of the PEEK serving as the backbone fusion device and meet the mechanical requirement of the backbone fusion device. Simultaneously, the HA fiber-enhanced PEEK backbone fusion device improves the biocompatibility of the PEEK and bones, improves the bioactivity of the PEEK and is favorable for the fusion of the bones.
Description
Technical field
The invention belongs to biomedical materials field, be specifically related to utilize the spinal fusion device of new material.
Background technology
Interbody fusion is as an important technology of spinal surgery, and oneself has especially brought into play irreplaceable effect through being widely used in the treatment of situations such as spinal fracture, dislocation in the treatment of degeneration spinal disease.Spinal fusion is the effective means of spine disorderses such as treatment spinal tuberculosis, infection, deformity, degeneration and intervertebral disk injury.
The 1950's, Cloward at first proposes fusion between way of escape lumbar vertebra (posterior lumbar interbody fusion, notion PLIF).See that from biomechanics this is a kind of comparatively ideal spinal fusion, develops into one of spinal surgery basic fundamental gradually.1984, the cervical vertebra that the DeBowes report is inserted horse with Rotating Stainless Steel Cage (cage) obtained healing.1988, Bagby was used for cage to merge between human cervical spine according to the Clowar method, and proposed " strutting-compress " principle and describe fibrous ring and strut the back and cage in the intervertebral space is formed compress fixed mechanical mechanism.Invasive lumbar fusion device has the intervertebral space of strutting, make anterior longitudinal ligament in tension, recover intervertebral height, and the contraction by abdominal muscles, realize the stable of Invasive lumbar fusion device and promote interpyramidal bone fusion from the compression to Invasive lumbar fusion device such as heavy sensation of the whole body, its effect mainly is effectively to keep the height of intervertebral space and the stable sections that merges, thereby realizes the bone fusion of intervertebral.In the same year, Kuslich cooperates with Bagby, and adopt titanium alloy to make cage and be used for merging between lumbar vertebra, called after BAK (Bagby And Kuslich, BAK).Bay in 1989 designs metal threaded fusion support TFC, and (threaded fusion cage, TFC) BAK, TFC become the early stage representative of fusion device between lumbar vertebra.The spinal column Invasive lumbar fusion device can keep each to merge the stability of sections by tough belt tension effect around muscle contraction around the vertebral body and the vertebral body, along with the development of clinical and biomechanics Research and materialogy and the progress of configuration design, for the stability that merges sections provides more assurance.Cage is from the early stage screw-type cylinder bodily form, develops cuboid, ellipse and variform such as netted.Use the time that cage treatment lumbar disease has only short ten or twenty year, but its superiority aspect biomechanics receives publicity more and more, new design concept is constantly introduced, and technology, material improve day by day, upgrade, and present development faster.
At present the fusion device of using is clinically mainly made by titanium alloy and macromolecule PEEK material, yet in use all there is in various degree problem in two kinds of materials.
The elastic modelling quantity of metal spinal fusion device is higher than cortical bone far away, can cause stress shielding in vivo, thereby causes implant site to produce that osteoporosis, osteanabrosis, implant site are subsided, fusion device becomes flexible or complication such as slippage.Metal material can't see through X-ray, influences the observation of postoperative to the bone fusion site.
The spinal fusion device of making by the macromolecular material of synthetic (as polyether-ether-ketone, PEEK), though elastic modelling quantity with push away body bone coupling, have good corrosion resistance, can see through X-ray, the while also can cause a series of complication: nerve root injury; Fusion device is loosening; Fusion device subsides, and intervertebral space and intervertebral foramina height reduce; Do not merge etc.
Hydroxyapatite is that a kind of calcium phosphate is Hydroxyapatite (HA), extensively is present in the human body, mainly be distributed in skeleton and the tooth, so its biocompatibility is fine.Hydroxyapatite comes down to the staggered polymeric ceramic calcium phosphate salt/polymer of a kind of height, and wherein calcium P elements molar ratio is 1.67.In skeleton and tooth, calcium and phosphorus mainly exist with colloid calcium phosphate crystal form, and constitute complicated network structure jointly with collagenic protein.Hydroxyapatite can be combined closely with collagen protein and cell, promotes skeletal growth, plays the effect of key in being connected of hard and soft tissue.There are some researches show that early stage blood capillary forms the hydroxyapatite material of implantation and host bone is to provide support adhering to of cell in order to repair at damaged place.But conventional hydroxylapatite ceramic is a fragile material, only can be used for the artificial joint coating, and the biomaterial under the non-bearing conditions such as tin otica is used.
Summary of the invention
For overcoming above deficiency, the invention provides the spinal fusion device that the fibre-reinforced PEEK of HA makes.
HA fiber reinforcement PEEK spinal fusion device is characterized in that described spinal fusion device adopts the PEEK material to add the HA fiber and makes, and described HA fiber is that diameter is that nanoscale, length are micron-sized hydroxyapatite fiber.
Described PEEK is medical embedded type PEEK raw material.
The HA fiber that contains the 5%-30% mass fraction among the described HA fiber reinforcement PEEK.
Described HA fiber is through disperseing and the coupling processing.
Described HA fiber and the molding of PEEK mixed injection molding.
Described spinal fusion device is the spinal fusion device that is used for intervertebral disc, is used for the rectangle cube spinal fusion device of cervical vertebra or is used for the chess shape cube spinal fusion device of lumbar vertebra.
Technique effect:
Use HA fiber reinforcement PEEK material and make in the spinal fusion device, not only overcome many shortcomings of metal material spinal fusion device, also can effectively overcome the deficiency of PEEK and HA itself.
The spinal fusion device that the present invention adopts HA fiber reinforcement PEEK injection mo(u)lding to make had both been avoided existing stress shielding of metal fusion device and metal fragment problem, and compatible CT and MRI inspection.
With special process HA being made diameter is nanoscale, and length is micron-sized fiber, can improve the mechanical performance of HA greatly.Add small amount of H A fiber among the PEEK, utilize the special performance of high strength, hardness and the fiber of HA fiber can improve the original performance of PEEK, guarantee the elastic modelling quantity of PEEK and bone coupling simultaneously, after implanting, HA also can have good amalgamation with bone.
The present invention is applied to spinal fusion device with HA fiber reinforcement PEEK, can strengthen the intensity of PEEK, can overcome the deficiency of PEEK as spinal fusion device, satisfy the mechanics requirement of spinal fusion device, simultaneously, HA fiber reinforcement PEEK spinal fusion device of the present invention has improved the biocompatibility of PEEK and bone, reaches the bone fusion with bone in vivo.
The specific embodiment
The present invention is further illustrated below in conjunction with specific embodiment.
Embodiment 1
Spinal fusion device is rectangular Fructus Musae type, wide 14mm, and long 25mm, high 10mm, wall thickness 2.5mm, upper and lower surface has the anatomical form structure, and the tooth engaged height on it is 0.5mm.Be applicable to patient L5/S1 intervertebral disc prolapse.
HA fiber reinforcement PEEK spinal fusion device, spinal fusion device material therefor are the medical embedded type PEEK material of German EVONIK company import.The HA fiber is the micron-sized self-control hydroxyapatite fiber of diameter nanoscale, length.HA fiber addition is 20%.
Embodiment 2
The physical dimension of spinal fusion device is with embodiment 1.But fusion device has the gradient of low early and high after 5 degree.Wide 14mm, long 25mm, high 10mm, wall thickness 2.5mm, upper and lower surface has the anatomical form structure, and the tooth engaged height on it is 0.5mm.
HA fiber reinforcement PEEK spinal fusion device, spinal fusion device material therefor are the medical embedded type PEEK material of German EVONIK company import.The diameter of HA fiber is a nanoscale, and length is micron-sized self-control hydroxyapatite fiber, through disperseing and the coupling processing.HA fiber addition is 20%.Be applicable to patient L4/L5 intervertebral disc prolapse.
Embodiment 3
HA fiber reinforcement PEEK spinal fusion device, spinal fusion device material therefor are the medical embedded type PEEK material of German EVONIK company import.The diameter of HA fiber is a nanoscale, and length is micron-sized self-control hydroxyapatite fiber, through disperseing and the coupling processing.HA fiber addition is 30%.Be applicable to patient L5/S1 intervertebral disc prolapse.
Embodiment 4
HA fiber reinforcement PEEK spinal fusion device, spinal fusion device material therefor are the medical embedded type PEEK material of German EVONIK company import.The diameter of HA fiber is a nanoscale, and length is micron-sized self-control hydroxyapatite fiber.HA fiber addition is 10%.
Embodiment 5
HA fiber reinforcement PEEK spinal fusion device, spinal fusion device material therefor are the medical embedded type PEEK material of German EVONIK company import.The diameter of HA fiber is a nanoscale, and length is micron-sized self-control hydroxyapatite fiber.HA fiber addition is 5%.
Embodiment 6
HA fiber reinforcement PEEK spinal fusion device, spinal fusion device material therefor are the medical embedded type PEEK material of German EVONIK company import.The diameter of HA fiber is a nanoscale, and length is micron-sized self-control hydroxyapatite fiber.HA fiber addition is 25%.
Other embodiment
Spinal fusion device of the present invention has various design type and size, to adapt to different patients and the different past damaged parts of ridge.
Also comprise the rectangle cube spinal fusion device that is applicable to cervical vertebra, wide 13mm, long 13mm, high 7mm.
Also comprise the chess shape cube spinal fusion device that is applicable to lumbar vertebra, wide 25mm, long 13mm, high 13mm, or the like.
More than the bending strength of each embodiment about 160MPa, elastic modelling quantity is about 106Pa.The bending strength of adult's bone is 160Mpa, and elastic modelling quantity is about 18Gpa, and this explanation HA fibre-reinforced PEEK material still relatively meets the mechanics standard of human body bone on mechanical strength.
Each embodiment proves and improves medical embedded level PEEK mechanical performance and biocompatibility, and the interpolation gross mass is that the HA fiber of 5%-30% is effective in PEEK.Mix 5%, 10%, 15%, 20%, 30%, hardness and the intensity of the raising PEEK that they can both be in various degree also have in various degree improvement to biocompatibility.
For making HA fiber homodisperse better, and combine with PEEK more securely, the HA fiber with should do dispersion treatment before PEEK mixes and coupling is handled.HA fiber reinforcement PEEK spinal fusion device can strengthen the intensity of PEEK, overcome the deficiency of PEEK as spinal fusion device, satisfy the mechanics requirement of spinal fusion device, simultaneously, HA fiber reinforcement PEEK spinal fusion device of the present invention has improved the biocompatibility of PEEK and bone, improve the biological activity of PEEK, be beneficial to the fusion of bone.
Claims (6)
1.HA fiber reinforcement PEEK spinal fusion device is characterized in that described spinal fusion device adopts the PEEK material to add the HA fiber and makes, described HA fiber is that diameter is that nanoscale, length are micron-sized hydroxyapatite fiber.
2. HA fiber reinforcement PEEK spinal fusion device according to claim 1 is characterized in that described PEEK is medical embedded type PEEK raw material.
3. HA fiber reinforcement PEEK spinal fusion device according to claim 1 is characterized in that described HA fiber quality mark is 5%-30%.
4. HA fiber reinforcement PEEK spinal fusion device according to claim 1 is characterized in that described HA fiber is through disperseing and the coupling processing.
5. HA fiber reinforcement PEEK spinal fusion device according to claim 1 is characterized in that described HA fiber and the molding of PEEK mixed injection molding.
6. according to the arbitrary described spinal fusion device of claim 1-5, it is characterized in that described spinal fusion device is the spinal fusion device that is used for intervertebral disc, be used for the rectangle cube spinal fusion device of cervical vertebra or be used for the chess shape cube spinal fusion device of lumbar vertebra.
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| CN2011100663519A CN102178983A (en) | 2011-03-18 | 2011-03-18 | HA fiber-enhanced PEEK backbone fusion device |
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| CN2011100663519A CN102178983A (en) | 2011-03-18 | 2011-03-18 | HA fiber-enhanced PEEK backbone fusion device |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102602000A (en) * | 2012-03-02 | 2012-07-25 | 北京奥精医药科技有限公司 | Implantable PEEK (polyetheretherketone) cold-pressing sintering molding method and spinal fusion cage |
| WO2015184696A1 (en) * | 2014-06-03 | 2015-12-10 | 深圳兰度生物材料有限公司 | Artificial intervertebral disc and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| US20100145393A1 (en) * | 2008-12-05 | 2010-06-10 | Medicinelodge, Inc. | Medical and dental porous implants |
| WO2010100267A1 (en) * | 2009-03-05 | 2010-09-10 | Dsm Ip Assets B.V. | Spinal fusion cage |
-
2011
- 2011-03-18 CN CN2011100663519A patent/CN102178983A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20100145393A1 (en) * | 2008-12-05 | 2010-06-10 | Medicinelodge, Inc. | Medical and dental porous implants |
| WO2010100267A1 (en) * | 2009-03-05 | 2010-09-10 | Dsm Ip Assets B.V. | Spinal fusion cage |
Non-Patent Citations (2)
| Title |
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| GABRIEL L. CONVERSE ET AL.: "Hydroxyapatite whisker-reinforced polyetherketoneketone bone ingrowth scaffolds", 《ACTA BIOMATERIALIA》, vol. 6, 6 August 2009 (2009-08-06), pages 856 - 863, XP026879126 * |
| GABRIEL L. CONVERSE ET AL.: "Mechanical properties of hydroxyapatite whisker reinforced polyetherketoneketone composite scaffolds", 《JOURNAL OF THE MECHANICAL BEHAVIOR OF BIOMEDICAL MATERIALS》, vol. 2, 29 July 2009 (2009-07-29), pages 627 - 635, XP026520008, DOI: doi:10.1016/j.jmbbm.2009.07.002 * |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102602000A (en) * | 2012-03-02 | 2012-07-25 | 北京奥精医药科技有限公司 | Implantable PEEK (polyetheretherketone) cold-pressing sintering molding method and spinal fusion cage |
| CN102602000B (en) * | 2012-03-02 | 2014-07-30 | 北京奥精医药科技有限公司 | Implantable PEEK (polyetheretherketone) cold-pressing sintering molding method and spinal fusion cage |
| WO2015184696A1 (en) * | 2014-06-03 | 2015-12-10 | 深圳兰度生物材料有限公司 | Artificial intervertebral disc and preparation method thereof |
| CN105147420A (en) * | 2014-06-03 | 2015-12-16 | 深圳兰度生物材料有限公司 | Artificial intervertebral disk and preparation method thereof |
| CN105147420B (en) * | 2014-06-03 | 2017-07-28 | 深圳兰度生物材料有限公司 | Artificial intervertebral disk and preparation method thereof |
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Application publication date: 20110914 |