CN101267783A - Multi-composite disc prosthesis - Google Patents

Abstract

The invention provides a multi-element composite intervertebral disc prosthesis which is suitable for implanting to a cleaned intervertebral discs vertebral pulp ring. The intervertebral disc prosthesis includes a whole type body with solid structure substantially, size and shape are suitable for being disposed in the cleaned intervertebral discs vertebral pulp ring. The body includes an exterior part composed of a first biological material and an inner part composed of a second biological material. Compression modulus of the second biological material is harder than the first material, the first biological material and second biological material are combined with chemical or physical method to form the multi-element composite material so as to form the solid body.

Description

Multi-composite disc prosthesis

Related application

The present invention advocates to file an application and name is called the U.S. Provisional Patent Application case the 60/700th of " SPINE POLYMER PATENT " on July 19th, 2005, No. 459 and filed an application on March 9th, 2006 and name is called the common pending application case the 11/372nd of " INTERLOCKED MODULAR DISC PROSTHESIS ", No. 357 priority, described two application cases all advocate again to file an application and name is called the U.S. Provisional Patent Application case the 60/685th of " SPINE DISCNUCLEUS II " on May 24th, 2005, No. 332, filed an application on March 9th, 2005 and name is called the U.S. Provisional Patent Application case the 60/660th of " MODULAR DISC PROSTHESIS ", No. 107, and on July 19th, 2005 filed an application and name is called the U.S. Provisional Patent Application case the 60/700th of " SPINE POLYMER PATENT ", No. 459 priority, the announcement disclosure of all these patent application cases all is incorporated herein with way of reference.The present invention also files an application with on March 9th, 2006 and name to be called No. the 11/372nd, 477, the common pending application case of " RAIL-BASEDMODULAR DISC NUCLEUS PROTHESIS " relevant, its disclosure is incorporated herein with way of reference.

Technical field

The present invention relates to a kind of implantable prosthese that is used to repair impaired intervertebral disc by and large.More specifically, the present invention relates to a kind of artificial nucleus replacement prosthese (artificial nucleus replacement prosthesis) that comprises a multi-part composite disc prosthesis, described multi-part composite disc prosthesis comprises the first softer outside biomaterial and the second harder inboard biomaterial.

Background technology

Spinal motion segment is made up of the anatomy of spine unit by two vertebral body gauges, comprises these two cones, the intervertebral disc that is clipped in the middle and attached ligament, and facet joint (facetjoint).Intervertebral disc is then formed by the soleplate that is positioned at vertebra top and bottom (end plate), soft kernel (being called vertebral pulp) and around the fibrous ring (annulus fibrosis) that vertebral pulp circumferentially extends.In normal intervertebral disc, vertebral pulp cushions the load that is applied, thus other key elements of protection spinal motion segment.Normal intervertebral disc is outwards to protrude and pressure is reacted by recline vertebral and fibrous ring.Fibrous ring is made up of collagen fiber and more a spot of elastic fiber, and the two all can resist tension force effectively.Yet fibrous ring self can not be born pressure and shearing force very effectively.

Along with people's aging, intervertebral disc is usually naturally and understandably degenerated.Degenerative disc disease also can make people's intervertebral disc occur degenerating.The degenerative disc disease of spinal column is one of modal disease that causes people's pain and deformity.When disc degeneration, vertebral pulp can dewater.And when nucleus dehydrates, it carries out buffered ability and just can weaken.Because the vertebral pulp after the dehydration no longer can bearing load, thereby load can be delivered to fibrous ring and facet joint.Fibrous ring and facet joint can not bear the institute that increases share and exert pressure and torsional load, thereby can little by little degenerate.Along with the degeneration of fibrous ring and facet joint, many other effects are just following, comprise gap turn narrow, form that bone is perverse, fibrous ring is broken, cartilage endplate fracture and degenerating and the cartilage degradation of facet joint.Fibrous ring and facet joint can be lost its structural stability, and small but ill motion occurs between vertebrae.

Along with annulus loses stability, it often outwards protrudes and may form and breaks, thereby makes the nucleus material evagination.Intervertebral disc is broken and the product that forms comprises that the particle of macroscopic chip, microcosmic and deleterious biochemical can build up.These breakdown products can stimulate in the intervertebral disc and the teleneuron of sensitivity on every side, cause back pain and cause sciatica (sciatica) sometimes.Muscle spasm can appear in the patient, the lower back motility reduces and feel pain when attempting to make trunk carry out proper motion.

Disc degeneration is irreversible.In some cases, health will finally make the joint of motion segment become stiff, thereby make intervertebral disc recover stable again effectively.Even in recovering stable situation again, described process may need many years, and the patient usually continues to feel to make the pain of life inconvenience.And when the pain that continues surpasses three months, usually cause the patient to seek its pain of operative treatment.

People have invented several makes spinal motion segment reach stable method.Some these method comprises: the fibrous ring zone is heated, to destroy teleneuron and reinforcing fibre ring; In motion segment side or intervertebral disc space, use rigidity or semirigid support component; Remove whole intervertebral disc and replace and roughly be inflexible articulated plastics artificial apparatus; Remove and replace vertebral pulp; And carry out spinal fusion, relate to and permanently merge near the vertebra of diseased intervertebral discs.

Until recently, spinal fusion generally is considered to be the effective surgery treatment that is used to alleviate the reserve pain that causes because of disc degeneration.Although this kind treatment usually can alleviate reserve pain effectively, yet the spinal motion segment that merges can be lost all intervertebral disc motion.Ill spinal segments lost-motion will inevitably limit patient's overall spinal column activeness.Finally, owing to try hard to compensate the fusion motion that sections lost near the motion segment that merges sections, spinal fusion can cause bigger stress to the contiguous intervertebral disc that merges sections, thereby usually causes these adjacent spinal segments to be degenerated too early.

Current exploitation is the therapeutic scheme that focuses on some or all motion that can keep ill spinal segments.These make spinal motion segment reach stable and do not have a kind of in the method for shortcoming of spinal fusion is total disc replacement (total disc replacement).Total disc replacement is a kind of have height invasive and operation very high to specification requirement, it takes out intervertebral disc by the operation of anterior approach or volume approach, and comprises and cut apart anterior vertical ligament, remove the cartilage endplate between vertebrae and the intervertebral disc, the major part and the whole inboard vertebral pulp of outside fiber ring.Then, synthetical total spinal disc prosthese is put into the intervertebral disc space that is cleared carefully.The many artificial total disc prostheses that had at present are by roughly being inflexible plastics (ultra-high molecular weight polyethylene (ultra high molecular weight polyethelyene for example as vertebral pulp; " UHMWPE ")) be folded between two metallic plates and form, wherein these two metallic plates are by anchoring or be attached on the vertebral.In " The Artificial Disc:Introduction; History and Socioecononics " the 21st chapter ClinicalEfficacy and Outcome in the Diagnosis of Low Back Pain the 205th～225 page (Raven publishing house, 1992) that Ray showed, the early development and the history design of artificial intervertebral disc are summed up.The example of these layer-stepping total spinal disc replacement devices for example is shown in United States Patent (USP) the 4th, 911, and No. 718, the 5th, 458, No. 643, the 5th, 545, No. 229 and the 6th, 533, in No. 818.

The artificial total disc of these types has several shortcomings.At first, because artificial disc prostheses is relatively large, thereby it needs relatively large surgical exposure so that be inserted into.Surgical exposure is big more, causes the probability of infection, hemorrhage even condition of illness just high more.In addition, be implanting prosthetic, must remove most of fibrous ring.Most meeting that removes fibrous ring reduces the stability of motion segment at least before the healing around artificial intervertebral disc.Moreover, because these devices are to be made by rigid material, if thereby its from intervertebral disc space, be shifted and touch the nerve or the vascular tissue of position, will cause serious harm.Another shortcoming is that inflexible artificial intervertebral disc replacement can not form the intervertebral disc mechanical performance of nature again.

A kind of alternative method of total disc replacement is replacement disc nucleus art (nucleus replacement).As artificial disc prostheses, these nucleus replacement also are inert non-biological prostheses.The invasive of nucleus replacement implant surgery is performed the operation less than total disc replacement, and generally comprises and only remove vertebral pulp and use prosthese to replace vertebral pulp, and described prosthese flexible also provides buffering to come the nucleus pulposus of simulating nature.The example that is used for the prosthese of replacement disc nucleus comprises: United States Patent (USP) the 4th, 772, No. 287, the 4th, 904, No. 260, the 5th, 192, No. 326, the 5th, 919, No. 236 and the 6th, 726, No. 721.

The replacement disc nucleus art is intended to the closer intervertebral disc mechanics of simulating nature.For this reason, some nucleus replacement is utilized hydrogel, because it has water absorption character, thereby these replacement can be expanded in position and allows more completely to fill the nucleus pulpous cavity that is cleared.Yet exist following compromise usually: the expansion that hydrogel obtained is big more, and the support structure that final products can provide is just more little.Therefore, many hydrogel nucleus disc replacement generally are to utilize the capsule of certain form or fabric to limit hydrogel material.For example, at United States Patent (USP) the 4th, 772, No. 287 and the 4th, 904, the implant described in No. 260 is made up of the water-setting blob of viscose that is encapsulated in the plastic fabric housing.At United States Patent (USP) the 5th, 192, the implant described in No. 326 then is made up of the hydrogel beads that fabric housing is sealed.If do not have capsule or other forms of limiter, because hydrogel has sliding character, thereby displacement appears in hydrogel easily.Regrettably, will there be the long term wear problem in described capsule or fabric housing, thereby this can cause capsule or housing can not limit hydrogel again and make hydrogel displacement occur.

Another kind of replacement disc nucleus method relates to implants air bag or other containers in vertebral pulp, filling therein then can solidified in position biocompatible materials.The example that this kind carries out the in-situ method of replacement disc nucleus comprises United States Patent (USP) the 6th, 443, No. 988 and the 7th, 001, and No. 431.One of them problem of described method is that the chemicosolidifying process is an exothermicity, can produce a large amount of heat and causes tissue damaged.In addition, there is disruptive probability in air bag between the phase of expansion, causes material to be bled in disc cavity and the surrounding tissue, and this may cause unexpected complication.

Another method is disclosed in No. the 5th, 865,846, the United States Patent (USP) giving people such as Bryan, wherein holds softer inside material in harder shell.The patent of Bryan discloses utilizes the elastomer of being made by two or more biocompatible materialses, and the Shao Shi D hardness (Shore D hardness) of wherein elastomeric softer inside part is 30, and the Shao Shi D hardness of harder Outboard Sections is 90.In the U.S. Patent Publication application case of giving Williams 2005/0119752A1 number, set forth the elastomeric similar approach of a kind of use, it discloses a kind of artificial intervertebral disc of being made by hydrogel, polyurethanes, thermoplastic elastomer (TPE) or other biological compatibility material, the Shore A hardness of wherein softer inboard vertebral pulp part is in the 20-70 scope, and the Shore A hardness of harder Outboard Sections is then in the 35-90 scope.Although look soft-hard the combination of the nature that is similar to nucleus pulposus and fibrous ring, yet these implants still have method and the problem identical with sandwich-type metal and polymer implant.

Therefore, need a kind of nucleus disc replacement that can solve the shortcoming of current method.

Summary of the invention

The present invention is a kind of multi-composite disc prosthesis, and it is fit to be implanted in the ring of the disc nucleus space that is cleared in people's spinal column.Described intervertebral disk prosthesis has solid substantially unitary body, and its size and shape are fit to be positioned in the ring of the disc nucleus space that is cleared.Described body has Outboard Sections that is made of first biomaterial and the inside part that is made of second biomaterial.The modulus of compressibility of second biomaterial is stiffer than the modulus of compressibility of first material, and first and second biomaterial can be incorporated into together and form multi-element composite material, thereby forms described solid body.

The present invention is used for substituting total disc replacement.Device of the present invention utilizes biocompatible materials to replace nucleus pulposus.The present invention has many advantages that are better than existing nucleus replacement.This kind advantage is in certain embodiments, and nucleus replacement of the present invention can be inserted the aperture that passes in the ring of back by having very little invasive operation, and the mass part of vertebra cartilage remains intact thereby make described ring reach on every side.

In addition, device of the present invention is the described ring of retighten, thus the buffering effect of providing and between described ring and vertebral pulp, recover more normal pressure distribution, to ease the pain.In an embodiment of apparatus of the present invention, nucleus replacement is made up of at least two kinds of biocompatible materialses, comprises internal layer that the biomaterial by hard modulus forms and by outer around forming than soft mode amount biomaterial.

In one aspect of the invention, implant can comprise the soft mode amount biomaterial and the inboard hard modulus biomaterial in the outside.In another aspect of this invention, the soft mode amount biomaterial in the outside and inboard hard modulus biomaterial can be incorporated into together by chemical mode.

In another aspect of this invention, described implant comprises the hybrid system of two kinds of biomaterials, and wherein said biomaterial can be by being formed based on the biocompatible polyurethane of vulcabond and polyhydric alcohol.

In one aspect of the invention, described implant can be by forming along several interconnection sections of the slide that is formed by hard modulus material, inserts each sections in the intervertebral disc space in regular turn and be connected to other sections and form the device of integral body.

Description of drawings

Fig. 1 is the cutaway view according to modular disc prosthesis of the present invention;

Fig. 2 is that modular disc prosthesis according to the present invention is inserted the view in stage first; And

Fig. 3 is the view of modular disc prosthesis according to the present invention in the final insertion stage.

The specific embodiment

Compare with traditional intervertebral disc or nucleus replacement, the present invention includes a kind of hybrid system, wherein Outboard Sections is made up of the soft mode amount material of natural imitation intervertebral disc, and inside part is then by providing support and stable forming than hard modulus material.Two kinds of biocompatible polymers can chemical mode be incorporated into and form hybrid system of the present invention together.Many traditional total disc replacement comprise top and bottom rigid plate and the nonrigid material that is folded in therebetween, and other existing nucleus replacement then are made up of a soft material that does not have stable rigid core.Hybrid system of the present invention provides the multiple advantage that is better than existing apparatus: soft Outboard Sections provides buffering, can not corrode soleplate as the relatively hard materials of other nucleus pulposus replacement simultaneously.In addition, soft Outboard Sections can be out of shape in response to about 30 to 300 pounds normal physiological power, with corresponding to required modulus.Owing to have this kind deformability, described prosthese can be formed on load suitably big or small on the physiology on the intervertebral disc soleplate.Therefore, can as in the firmer nucleus pulposus displacement implant situation, not make soleplate in time carrying out and the profile of excessive deformation and final applying implant.In addition, harder interior nuclear energy of the present invention provides support that implant lacked and the stability of being made by water-setting blob of viscose or chunk.

In one embodiment of this invention, nucleus replacement 10 can comprise several assemblies, and it inserts in the disc nucleus space that is cleared in regular turn.Because described device is each assembly that inserts, thereby inserts so in regular turn and can allow to have little surgical exposure, this is with some whole insertion thereby need have opposite than major operation exposed problems device.As shown in FIG. 1, the inboard that can be made by the hard modulus biomaterial of each assembly 20 connects track 22 and the outer ring made than soft mode amount biomaterial constitutes around layer 24.During inserting, first assembly can be along the slide of being made up of high modulus biomaterial to intervertebral disc on the intra-annular location.In one embodiment, described device is inserted the little opening that penetrates in the ring of back by the very little operation of invasive.Each assembly can with the adjacent component mechanical interlocking, after all inserting fully with convenient all component, make the assembly of interlocking comprise individual unit.

In one embodiment, device of the present invention can be made up of two kinds of biocompatible materialses with different hardness.In an embodiment of described device, these biocompatible materialses can be by forming based on the biocompatible polyurethane of vulcabond and polyhydric alcohol.In one embodiment, isocyanate component can be 4, and 4 '-'-diphenylmethane diisocyanate (4,4 '-diphenylmethane diisocyanate; " MDI "), and polyol component can be polytetramethylene ether (polytetramethyleneoxide; " PTMO ") 1000 and the combination of PTMO 2000.These polymer also can comprise chain extender (chain extender), cross-linking agent and catalyst.In one embodiment, chain extender can be 1,4-butanediol (butanediol; " BDO "); Cross-linking agent can be trimethyl propane (trimethylpropane; " TMP "); And catalyst can be two (dodecyl sulfenyl)-stannous methide (bis-(dodecylthio)-dimethylstannane; " Fomrez catalyst UL22 ").These two kinds of biomaterials can be incorporated into together and form hybrid system.For example, this kind combination can be chemical bond or physical bond.In one aspect of the invention, this kind combination can comprise amino-formate bond.

The those skilled in the art will know, also contain the other biological material and the biomaterial component of the complex that is suitable for this nucleus prosthesis, and this also belongs in the scope of the present invention.Other biomaterials that can be used in the scope of the invention include but not limited to: hydrogel, rubber, silicones, thermoplastic elastomer (TPE), acrylate monomer, curable epoxy resin, curable monomer, and arbitrary combination.

In an embodiment of described device, the outer ring of described device can be made of first biomaterial of forming than flexible polymer around coating, and described can providing than flexible polymer cushioned and supported, with the characteristic of natural imitation nucleus pulposus.In an embodiment of described device, outer polymer can be passed through modification, flows out for example analgesic, antibiotic, antitumorigenic substance or biological skeleton agent medicine or any other material requesteds such as (for example bone growth agent) so that can provide.Although keep the normally main target in the replacement disc nucleus of activeness, yet in some cases, may wish to promote certain bone fusion.This kind situation can comprise the replacement disc nucleus of cervical spine.

The solid polymer shell of described modular disc nucleus prosthesis can provide the eluting rate better and more controlled than some hydrogel material.In an alternate embodiment, in the described modular disc nucleus prosthesis, each polymeric material can comprise different elution rates.This will allow different medicines to have different eluting rates.

Softer biomaterial can be by percentage by weight forming than hard segment content in about 15% to 25% scope.One of ordinary skill in the art will know that it also contains other hard section weight percentage ranges that are in the described clear and definite scope, and this still belongs in the scope of the present invention.The modulus of compressibility of described softer biomaterial can be in about 10-20MPa scope.For example, described softer biomaterial can have the Shao Shi D hardness that is not more than 80 Shore A hardness and is not more than 40.The hot strength of described softer biomaterial can be in the 10-30MPa scope.In an embodiment of this device, described softer biomaterial can have the yield strength of 1-1.5MPa.The elastic modelling quantity of described softer biomaterial can be in the 6-8MPa scope.One of ordinary skill in the art will know that it also contains other scopes that are in the above-mentioned clear and definite scope, and this still belongs in the scope of the present invention.

One embodiment of described device can further comprise second biomaterial.Second biomaterial can be by the forming than hard polymer of high rigidity, preferablely is at least 55 polymer by Shao Shi D hardness and forms.The hardness of second biomaterial can provide support structure for inserting track and interlocking mechanism.In an alternate embodiment, second biomaterial can be by thermoplastic polyether polyurethane or polycarbonate polyurethane (for example

Or

) form.In one embodiment, second biomaterial can be by polyether-ether-ketone (poly-ether-ether-ketone; PEEK) or another polymer with similar rigidity form.In another alternate embodiment, second biomaterial can be by forming based on the polyurethanes of MDI, PTMO, it has hard section weight content in about 50% to 70% scope, hard section and the soft section component microphase-separated that has less even molecular weight chain length and have the best in prepolymer after treatment, distributes uniformly to provide in cured polymer on the macroscopic view.One of ordinary skill in the art will know that it also contains other hard section weight percentage ranges that are in the described clear and definite scope, and this still belongs in the scope of the present invention.

The hot strength of described hard biomaterial can be in the 40-75MPa scope.The yield strength of described hard biomaterial can be in the 20-45MPa scope.The elastic modelling quantity of described hard biomaterial can be in the 400-700MPa scope.The modulus of compressibility of described hard biomaterial can be in the 200-400MPa scope.One of ordinary skill in the art will know that it also contains other scopes that are in the above clear and definite scope, and this still belongs in the scope of the present invention.

In aspect of the first softer biomaterial, the percentage by weight of MDI can be in 5% to 35% weight percentage ranges of total cure polymer.In an alternate embodiment of the first softer biomaterial, the percentage by weight of MDI can be in 15% to 25% weight percentage ranges of total cure polymer.In one embodiment, the percentage by weight of MDI can be in about 18% to 20% weight percentage ranges of total cure polymer.One of ordinary skill in the art will know that it is also contained the percentage by weight that makes MDI account for total cure polymer and is in other interior scopes of above-mentioned clear and definite scope, and this still belongs in the scope of the present invention.

The percentage by weight of PTMO 1000 can be in 0% to 40% weight percentage ranges of total cure polymer in the first softer biomaterial.In an alternate embodiment, the percentage by weight of PTMO 1000 can be in 10% to 30% weight percentage ranges of total cure polymer.In one embodiment, the percentage by weight of PTMO 1000 can be in 25% to 27% weight percentage ranges of total cure polymer.One of ordinary skill in the art will know that it is also contained the percentage by weight that makes PTMO 1000 account for total cure polymer and is in other interior scopes of above-mentioned clear and definite scope, and this still belongs in the scope of the present invention.

The percentage by weight of PTMO 2000 can be in 0% to 80% weight percentage ranges of total cure polymer in the first softer biomaterial.In an alternate embodiment, the percentage by weight of PTMO 2000 can be in 40% to 60% weight percentage ranges of total cure polymer.In one embodiment, the percentage by weight of PTMO 2000 can be in 52% to 54% weight percentage ranges of total cure polymer.One of ordinary skill in the art will know that it is also contained the percentage by weight that makes PTMO 2000 account for total cure polymer and is in other interior scopes of above-mentioned clear and definite scope, and this still belongs in the scope of the present invention.

The percentage by weight of BDO can be in 0% to 10% weight percentage ranges of total cure polymer in the first softer biomaterial.In an alternate embodiment, the percentage by weight of BDO can be in 0% to 5% weight percentage ranges of total cure polymer.In one embodiment, the percentage by weight of BDO can be in 1% to 2% weight percentage ranges of total cure polymer.One of ordinary skill in the art will know that it is also contained the percentage by weight that makes BDO account for total cure polymer and is in other interior scopes of above-mentioned clear and definite scope, and this still belongs in the scope of the present invention.

The percentage by weight of TMP can be in 0% to 5% weight percentage ranges of total cure polymer in the first softer biomaterial.In an alternate embodiment, the percentage by weight of TMP can be in 0% to 0.1% weight percentage ranges of total cure polymer.In one embodiment, the percentage by weight of TMP can be in 0.06% to 0.08% weight percentage ranges of total cure polymer.One of ordinary skill in the art will know that it is also contained the percentage by weight that makes TMP account for total cure polymer and is in other interior scopes of above-mentioned clear and definite scope, and this still belongs in the scope of the present invention.

The percentage by weight of UL22 can be in 0% to 2% weight percentage ranges of total cure polymer in the first softer biomaterial.In an alternate embodiment, the percentage by weight of UL22 can be in 0% to 1% weight percentage ranges of total cure polymer.In one embodiment, the percentage by weight of UL22 can be in 0.0001% to 0.0030% weight percentage ranges of total cure polymer.One of ordinary skill in the art will know that it is also contained the percentage by weight that makes UL22 account for total cure polymer and is in other interior scopes of above-mentioned clear and definite scope, and this still belongs in the scope of the present invention.

In aspect of the first softer biomaterial, MDI generally is associated with the hard segment content and the hardness of cure polymer with the combination weight of BDO.In an embodiment of the first softer biomaterial, the combination weight percentage ratio of MDI and BDO can be in about 15% to 25% weight percentage ranges of total cure polymer.In an embodiment of the first softer biomaterial, the combination weight percentage ratio of MDI and BDO can be in about 20% to 22% weight percentage ranges of total cure polymer.One of ordinary skill in the art will know that it is also contained the combination weight percentage ratio that makes MDI and BDO account for total cure polymer and is in other interior scopes of above-mentioned clear and definite scope, and this still belongs in the scope of the present invention.

The first softer biomaterial can comprise two kinds of independent prepolymers-A part and B part, and it is mixed in together and forms cured polymer.In one embodiment, A forms by MDI and PTMO 2000 are together handled, and the B part then is to form by PTMO 1000, BDO, TMP and UL22 are together handled.Can handle and form these prepolymers-A part and B part arbitrary combination of MDI, PTMO 1000, PTMO 2000, BDO, TMP, UL22 and/or other suitable components.Therein that A part and B is partially mixed in an embodiment of the first softer biomaterial that forms cure polymer together, A part and the partially mixed one-tenth of B can be made total isocyanates to the ratio of polyhydric alcohol in about 0.96 to 1.04 scope.In one embodiment, A part and the partially mixed one-tenth of B can be made total isocyanates to the ratio of polyhydric alcohol in about 1.01 to 1.03 scopes.One of ordinary skill in the art will know, it is also contained makes total isocyanates be in other scopes in the above-mentioned clear and definite scope to the ratio of polyhydric alcohol, and this still belongs in the scope of the present invention.

The percentage by weight of MDI can be in 30% to 70% weight percentage ranges of total cure polymer in the second hard biomaterial.In an alternate embodiment of the second hard biomaterial, the percentage by weight of MDI can be in 40% to 60% weight percentage ranges of total cure polymer.In an embodiment of the second hard biomaterial, the percentage by weight of MDI can be in about 47% to 49% weight percentage ranges of total cure polymer.One of ordinary skill in the art will know that it is also contained the percentage by weight that makes MDI account for total cure polymer and is in other interior scopes of above-mentioned clear and definite scope, and this still belongs in the scope of the present invention.

The percentage by weight of PTMO 1000 can be in 0% to 40% weight percentage ranges of total cure polymer in the second hard biomaterial.In an alternate embodiment of the second hard biomaterial, the percentage by weight of PTMO 1000 can be in 10% to 30% weight percentage ranges of total cure polymer.In an embodiment of the second hard biomaterial, the percentage by weight of PTMO 1000 can be in 20% to 22% weight percentage ranges of total cure polymer.One of ordinary skill in the art will know that it is also contained the percentage by weight that makes PTMO 1000 account for total cure polymer and is in other interior scopes of above-mentioned clear and definite scope, and this still belongs in the scope of the present invention.

The percentage by weight of PTMO 2000 can be in 0% to 40% weight percentage ranges of total cure polymer in the second hard biomaterial.In an alternate embodiment of the second hard biomaterial, the percentage by weight of PTMO 2000 can be in 10% to 30% weight percentage ranges of total cure polymer.In an embodiment of the second hard biomaterial, the percentage by weight of PTMO 2000 can be in 15% to 17% weight percentage ranges of total cure polymer.One of ordinary skill in the art will know that it is also contained the percentage by weight that makes PTMO 2000 account for total cure polymer and is in other interior scopes of above-mentioned clear and definite scope, and this still belongs in the scope of the present invention.

The percentage by weight of BDO can be in 0% to 35% weight percentage ranges of total cure polymer in the second hard biomaterial.In an alternate embodiment of the second hard biomaterial, the percentage by weight of BDO can be in 5% to 25% weight percentage ranges of total cure polymer.In an embodiment of the second hard biomaterial, the percentage by weight of BDO can be in about 14% to 16% weight percentage ranges of total cured polyurethane.One of ordinary skill in the art will know that it is also contained the percentage by weight that makes BDO account for total cure polymer and is in other interior scopes of above-mentioned clear and definite scope, and this still belongs in the scope of the present invention.

The percentage by weight of TMP can be in 0% to 5% weight percentage ranges of total cured polyurethane in the second hard biomaterial.In an alternate embodiment of the second hard biomaterial, the percentage by weight of TMP can be in 0% to 1% weight percentage ranges of total cured polyurethane.In an embodiment of the second hard biomaterial, the percentage by weight of TMP can be in 0.1% to 0.3% weight percentage ranges of total cured polyurethane.One of ordinary skill in the art will know that it is also contained the percentage by weight that makes TMP account for total cure polymer and is in other interior scopes of above-mentioned clear and definite scope, and this still belongs in the scope of the present invention.

The percentage by weight of UL22 can be in 0% to 2% weight percentage ranges of total cured polyurethane in the second hard biomaterial.In an alternate embodiment of the second hard biomaterial, the percentage by weight of UL22 can be in 0% to 1% weight percentage ranges of total cured polyurethane.In one embodiment, the percentage by weight of UL22 can be in 0.0001% to 0.002% weight percentage ranges of total cured polyurethane.One of ordinary skill in the art will know that it is also contained the percentage by weight that makes UL22 account for total cure polymer and is in other interior scopes of above-mentioned clear and definite scope, and this still belongs in the scope of the present invention.

In an embodiment of the second hard biomaterial, MDI generally is associated with the hard segment content and the hardness of cure polymer with the combination weight of BDO.The combination weight of MDI and BDO can be in about 50% to 70% weight percentage ranges of cure polymer gross weight.In one embodiment, the combination weight of MDI and BDO can be in about 62% to 64% weight percentage ranges of cure polymer gross weight.One of ordinary skill in the art will know that it is also contained the combination weight percentage ratio that makes MDI and BDO account for total cure polymer and is in other interior scopes of above-mentioned clear and definite scope, and this still belongs in the scope of the present invention.

Follow the trail of being described in more detail of embodiment for one about Fig. 2 of the present invention and 3, see also the common pending application case that aforementioned name is called " RAIL-BASED MODULAR DISC PROTHESIS ", its disclosure is incorporated herein with way of reference.

In aspect of implant of the present invention, the second hard biomaterial can partly be made of two kinds of independent prepolymers-A part and B.The group that arbitrary other combinations of A part and the optional free MDI of B part, TDI, PTMO 1000, PTMO 2000, BDO, TMP, UL22 and/or suitable component are formed.In addition, the molecular weight chain length of the polymer colony that comprised less than the B part of the molecular weight chain length that the A section processes can be become to make one or two kind of polymer colony that prepolymer comprises.In one embodiment, MDI, PTMO 1000 and PTMO2000 are together handled and form the A part.Preferably, BDO, TMP and UL22 are together handled and form the B part.A part and the partially mixed one-tenth of B can be made total isocyanates to the ratio of polyhydric alcohol in about 0.96 to 1.04 scope.In one embodiment, can make isocyanates to the ratio of polyhydric alcohol in about 1.01 to 1.03 scopes.One of ordinary skill in the art will know, it is also contained makes isocyanates be in other scopes in the above-mentioned clear and definite scope to the ratio of polyhydric alcohol, and this still belongs in the scope of the present invention.The those skilled in the art can come into plain view to the various alter modes of announcement device and method after reading this disclosure.Above content is not to plan to limit scope of the present invention, and scope of the present invention is limited by claims only.

Claims (15)

1. intervertebral disk prosthesis, it is fit to be implanted in the ring of the disc nucleus space that is cleared in people's spinal column, and described intervertebral disk prosthesis comprises:

Solid substantially unitary body, its size and shape are fit to be positioned in the ring of the described disc nucleus space that is cleared, and described body has:

The Outboard Sections that constitutes by first biomaterial; And

The inside part that constitutes by second biomaterial,

The modulus of compressibility of wherein said second biomaterial is stiffer than the modulus of compressibility of described first material, and described first and second biomaterial is incorporated into together and forms multi-element composite material, thereby constitutes described solid body.

2. intervertebral disk prosthesis as claimed in claim 1 is characterized in that, described first biomaterial combines with chemical mode with described second biomaterial.

3. intervertebral disk prosthesis as claimed in claim 1 is characterized in that, described first biomaterial combines with physics mode with described second biomaterial.

4. intervertebral disk prosthesis as claimed in claim 1 is characterized in that, described first biomaterial and described second biomaterial are respectively polymer.

5. intervertebral disk prosthesis as claimed in claim 4 is characterized in that, described first biomaterial and described second biomaterial are respectively polyurethanes.

6. intervertebral disk prosthesis as claimed in claim 4 is characterized in that, described second biomaterial is to be selected from the group that is made up of following: thermoplastic polyethers-carbamate, Merlon-carbamate and polyether-ether-ketone.

7. intervertebral disk prosthesis as claimed in claim 4 is characterized in that, described first biomaterial is to be selected from the group that is made up of following: thermoplastic polyethers-carbamate, Merlon-carbamate and polyether-ether-ketone.

8. intervertebral disk prosthesis as claimed in claim 5 is characterized in that, described polyurethanes is to be made of vulcabond and polyhydric alcohol.

9. intervertebral disk prosthesis as claimed in claim 5 is characterized in that, the described component of described polyurethanes is to be selected from the group that is made up of following: vulcabond, polyhydric alcohol, catalyst, chain extender and cross-linking agent.

10. intervertebral disk prosthesis as claimed in claim 5 is characterized in that, the described polyurethanes of described first biomaterial has the hard segment content in about 15% to 25% weight percentage ranges.

11. intervertebral disk prosthesis as claimed in claim 5 is characterized in that, the described polyurethanes of described second biomaterial has the hard segment content in about 50% to 70% weight percentage ranges.

12. intervertebral disk prosthesis as claimed in claim 1 is characterized in that, the modulus of compressibility of described first biomaterial is in about 10-20MPa scope.

13. intervertebral disk prosthesis as claimed in claim 1 is characterized in that, described second biomaterial has and is at least 55 Shao Shi D hardness.

14. intervertebral disk prosthesis as claimed in claim 1, it is characterized in that, described solid unitary body is that the section by a plurality of interconnection constitutes, and section original position in the described intervertebral disc space that empties of described a plurality of interconnection is placed, with described size and the described shape that forms described solid unitary body.

15. intervertebral disk prosthesis as claimed in claim 1, it is characterized in that, at least one outermost layer of described Outboard Sections also comprises at least a medicine, and described at least a medicine is operationally carried by described first biomaterial, with eluting after described prosthese is implanted.

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