CN101007184A - Ultra-high-molecular-weight-polyethylene and drug complexes artificial joint material and its preparation method, and artificial joint prepared therefrom - Google Patents
Ultra-high-molecular-weight-polyethylene and drug complexes artificial joint material and its preparation method, and artificial joint prepared therefrom Download PDFInfo
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- CN101007184A CN101007184A CN 200610022227 CN200610022227A CN101007184A CN 101007184 A CN101007184 A CN 101007184A CN 200610022227 CN200610022227 CN 200610022227 CN 200610022227 A CN200610022227 A CN 200610022227A CN 101007184 A CN101007184 A CN 101007184A
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- molecular weight
- high molecular
- ultra
- artificial joint
- weight polyethylene
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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
- A61F2/32—Joints for the hip
- A61F2/34—Acetabular cups
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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 invention disclosed a kind of super high molecular weight polyethylene/medicine compounded artificial joint as well as the preparing method and the prepared coax joint. The materials of the invention include 99.5-90 shares (by weight) of super high molecular weight polyethylene and 0.5-10 shares of medicine that can restrain osteolysis. After implanting the invention in human bodies, it can prevent the ostelysis of artificial hip joint and total knee prosthesis under common conditions; it can also prevent the cinch of prosth, prolong the service life of artificial joints, and ease the pain and burden of patients.
Description
Technical field
The present invention relates to a kind of biomaterial for medical purpose, relate in particular to a kind of artificial joint material and its production and use and by its hip joint that makes.
Background technology
With the ultra-high molecular weight polyethylene is that the prosthetic replacement that one of main material is made uses at clinical success, for the quality of life of improving numerous joint disease patients provides possibility.Developed countries such as present America and Europe, the quantity of annual only artificial hip, knee prosthesis is above 500,000 person-times.The patient that China accepts the artificial joint implant surgery every year just has above 30,000.Through the effort of many decades, artificial joint is at material modification, and aspects such as fixed form and Machine Design all are greatly improved.But the service life of artificial joint is very limited all the time, a large amount of artificial hip joints and artificial knee joint (prosthese) is arranged at present because the loosening needs in later stage are overhauled every year, and this makes countless patients have to bear repeatedly painful.Think that at present the main cause of prosthetic loosening is that the bone dissolving that the prosthese position takes place causes.
Bone dissolving be meant wear particle prosthese-bone interface or bone cement-bone interface induce bone loss due to a series of biological respinses (Mao Binyao, the Quan Ming of department etc. the artificial hip joint surgery. People's Health Publisher .2004).Artificial joint motion and interface fine motion produce a large amount of abrasive dusts inevitably between the interface, especially the ultra-high molecular weight polyethylene abrasive dust of articular surface generation.These abrasive dusts are diffused in the Periprosthetic tissue along with joint fluid moves in the useful space of joint, have an effect particularly huge cytophilic phagocytosis with the cell of Periprosthetic.Medium and cytokine that these cells are worn and can secrete multiple promotion bone resorption after the particle excitation are as prostaglandin-2 (PGE-2), tumor necrosis factor-alpha (TNF-α), interleukin-1 ' beta ' (IL-1 β) etc.These media and cytokine can be separately or synergy, activate osteoclast, caused the absorption and the dissolving of Periprosthetic sclerotin again by osteoclast, finally cause prosthetic loosening.
(Estrogen is E) to bone metabolism and keep normal bone and measure important regulatory role for estrogen.Estrogen deficiency will cause osteoclast (OC) number and active increase etc., and cause bone loss.Studies show that, estrogen can by number of ways direct or indirect act on osteoclast, suppress its differentiation and activity.Therefore, lack estrogen and can cause bone resorption greater than bone formation, and suppress the intestinal calcium absorption and urinate calcium heavily to absorb, complementing estrogen is the dissolved effective way of control bone.
Bisphosphonate class of drugs is an antimetabolic osteopathia medicine with the fastest developing speed over nearly 20 years, can be used for treating hypercalcemia, osteodynia and the scleromalacia etc. that bone dissolves, malignant metastatic tumor of bone causes.Medicines such as etidronate disodium, clodronate disodium, Pamidronate Disodium, Alendronate sodium, risedronate sodium, tiludronic acid disodium, her this Alendronate and ineadronic acid disodium have been manufactured experimently in succession since the nineties.Diphosphonate can directly suppress mature osteoclast, also acts on its precursor simultaneously, reduces the osteoclast differentiation and influences it and the cohesive process of bone surface.But the Alendronate sodium specific distribution is on the bone resorption surface, when osteoclast during near bone surface, discharging acidic materials causes the surrounding pH value to descend, Alendronate sodium is just separated from bone surface, enter in the osteoclast, by influencing the function that cytoskeleton reduces osteoclast, promote the apoptosis of osteoclast, thereby reduce the quantity of osteoclast in the tissue.Domestic Lu Jingtao etc. point out in to the research of Alendronate sodium to external osteoclast bone resorption influence: Alendronate sodium can make the surface area of osteoclast absorption lacuna number, absorption lacuna obviously reduce.
But above estrogen or bisphosphonate class of drugs are to treat by mode oral or injection, and bioavailability is low and side effect is big, and medicine is the time weak point of generation effect in vivo, can not suppress the bone dissolving effectively, prevents prosthetic loosening.
In the existing prosthetic replacement operation, artificial joint be fixed with dual mode, the fixing and biological fixation (none-cement is fixed) of bone cement.Bone cement is fixing just to be meant, in the replacement operation process, bone cement is filled out in people's pulp cavity, utilizes the solidification of bone cement, and the shank of artificial hip joint is fixed in the medullary cavity.Another kind of fixed form is biological fixation, claims none-cement to fix again.Be meant and utilize existing characteristic biology, rely on bone trabecular growth, enter the micropore surface of prosthese, reach the fixed form that heals between bone-prosthese.Above-mentioned two kinds of fixed forms are all owing to factors such as the motion in joint, wearing and tearing cause artificial joint prosthesis loosening.Therefore, in the prosthetic replacement, control bone how dissolving effectively prevents prosthetic loosening, is a problem that urgency is to be solved.
Summary of the invention
First purpose of the present invention provides a kind of ultra-high molecular weight polyethylene/medicine compound artificial joint material, behind the artificial joint implant into body made from this kind material, can prevent effectively that the bone of artificial joint under the normal wear situation from dissolving and the generation of prosthetic loosening, obviously prolong the service life of artificial joint, alleviate patient's misery and burden.
The present invention solves its technical problem, the technical scheme that is adopted is: a kind of ultra-high molecular weight polyethylene/medicine compound artificial joint material, its component and weight proportion thereof are: 99.5～90 parts of ultra-high molecular weight polyethylenes have 0.5～10 part of the medicine that suppresses the bone dissolution.
Compared with prior art, the invention has the beneficial effects as follows: the present invention is compound with the medicine with inhibition bone dissolving function with ultra-high molecular weight polyethylene, obtains being used for the material of manual manufacture artificial joint.The artificial hip joint and the artificial knee joint that make with this material, under the normal wear situation, have in the artificial joint medicine that suppresses the bone dissolution with wear particle be discharged into joint lacuna artificial joint around, the direct or indirect osteoclast that acts on, the differentiation and the activity that suppress osteoclast, reduce the bone dissolving that osteoclast causes, thereby effectively prevent the generation of prosthetic loosening.Place artificial joint material inside owing to have the medicine that suppresses the bone dissolution, directly act between bone-prosthese, this part, direct administering mode, make the dissolved therapeutic effect of Periprosthetic bone obvious, directly, simply, effectively, overcome oral or injection waits the treatment bioavailability of other therapeutic modality low, shortcomings such as side effect and action time are short, can prevent and treat the bone dissolving that takes place behind the prosthetic replacement of biological fixation effectively, prolong the service life of artificial joint, reduce overhauling of artificial joint, change frequency, thereby alleviate patient's misery and financial burden greatly.
Above-mentioned ultra-high molecular weight polyethylene is that diameter is the powder of 60 μ m～270 μ m, and its molecular weight is 2,000,000～5,000,000; Having the bone of inhibition dissolved drug is estradiol or Alendronate sodium.
This superhigh molecular weight polyethylene material wearability is good, and good biocompatibility can be used for prosthetic replacement's material.Estradiol as estrogen, Alendronate sodium as bisphosphonate class of drugs, all can suppress the formation of osteoclast effectively, reduce the quantity of osteoclast, promote the osteoclast apoptosis, reduce the bone dissolving, both had good bone inhibitory action, they also have good heat stability simultaneously, the temperature more than 180 ℃ can be stood,, still good drug effect can be kept through containing the artificial joint preparation process of heating process.
Second purpose of the present invention provides above-mentioned ultra-high molecular weight polyethylene/medicine compound artificial joint preparation methods.
The present invention solves its second goal of the invention, the technical scheme that is adopted is: a kind of ultra-high molecular weight polyethylene/medicine compound artificial joint preparation methods, its way is: get the ultra-high molecular weight polyethylene of described deal, the medicine with inhibition bone dissolution of the described deal of adding, behind the uniform mixing; Promptly make pulverous compound artificial joint material.
Above-mentioned ultra-high molecular weight polyethylene powder with have the medicine uniform mixing that suppresses the bone dissolution after, also use the hot press molding, promptly make the solid-state compound artificial joint material of molding.
Adopt above method can produce the solid-state compound artificial joint material of Powdered or typing of the present invention easily, and ultra-high molecular weight polyethylene and medicine all do not pass through any chemical treatment, its characteristic will well be kept.
Above-mentioned ultra-high molecular weight polyethylene powder or granule and have the mixed uniformly a kind of specific practice of medicine that suppresses the bone dissolution and be: the medicine that suppresses the bone dissolution that has of getting above-mentioned deal adds in its solvent, the dissolving back adds the ultra-high molecular weight polyethylene powder of above-mentioned deal, behind the uniform mixing, make the homodisperse suspension of medicine, vacuum drying.
To have like this in its solvent of medicine dissolution that suppresses the bone dissolution, and add the ultra-high molecular weight polyethylene powder after the dissolving more therein and form suspension, vacuum drying obtains solid mixt again, makes the easier and ultra-high molecular weight polyethylene mix homogeneously of medicine.
The 3rd purpose of the present invention provides a kind of artificial joint by above-mentioned ultra-high molecular weight polyethylene/medicine compound artificial joint material preparation.
Its 3rd purpose of solution of the present invention, the first kind of technical scheme that is adopted is: a kind of artificial joint by above-mentioned ultra-high molecular weight polyethylene/medicine compound artificial joint material preparation, this artificial joint is an artificial hip joint, the endosexine of artificial hip joint mortar is wherein made by above-mentioned ultra-high molecular weight polyethylene/medicine combined artificial hip cotyle material, and the thickness of this endosexine is 2-4mm; The extexine of hip cotyle then becomes for ultrahigh molecular weight polyethylene, and thickness is 8-10mm.
Like this, only use material of the present invention, can effectively prevent the bone dissolving, reduced the consumption of expensive inhibition bone dissolved substance again, reduced the manufacturing cost of cotyla in the endosexine that produces the bone wearing and tearing.
Its 3rd purpose of solution of the present invention, the second kind of technical scheme that is adopted is: a kind of artificial joint by above-mentioned ultra-high molecular weight polyethylene/medicine compound artificial joint material preparation, this artificial joint is an artificial knee joint, and artificial shin vinyl disc is wherein made by described ultra-high molecular weight polyethylene/medicine compound artificial joint material.
The present invention is further illustrated below in conjunction with accompanying drawing and concrete embodiment.
Description of drawings
Fig. 1 is the sectional structure sketch map of the hip cotyle in the artificial hip joint of the embodiment of the invention eight.
Fig. 2 is the sectional structure sketch map of the hip cotyle in the artificial hip joint of the embodiment of the invention eight.
The specific embodiment
Embodiment one
Getting 0.5 part of estradiol, to join 99.5 parts, diameter be that 60 μ m～270 μ m and molecular weight are in 250 ± 500,000 the ultra-high molecular weight polyethylene powder, behind the mix homogeneously, promptly to get pulverous compound artificial joint material.
Embodiment two
Get 10 parts of estradiol and add its solvent---the ultra-high molecular weight polyethylene powder mixes that in the acetone, add 90 parts, molecular weight then and be 450 ± 500,000, diameter is 60 μ m～270 μ m evenly becomes suspension, behind the vacuum drying, promptly gets pulverous composite.
Embodiment three
Get in 6 parts of estradiol Alendronate sodiums adding distilled water and dissolve, add 94 parts, molecular weight then and be 350 ± 500,000, diameter is in the ultra-high molecular weight polyethylene powder of 60 μ m～270 μ m, after being mixed into suspension, make homodisperse mixture behind the vacuum drying, put into the hot press mould then and carry out hot pressing, behind precompressed, heating, insulation, cooling four-stage, take out mould, promptly get the solid-state composite of finalizing the design.
Embodiment four
Getting 10 parts of Alendronate sodiums, to join 90 parts, diameter be that 60 μ m～270 μ m and molecular weight are in 250 ± 500,000 the ultra-high molecular weight polyethylene powder, to put into the hot press mould behind the mix homogeneously and carry out hot pressing.Behind precompressed, heating, insulation, cooling four-stage, take out mould, promptly get the solid-state compound artificial joint material of finalizing the design.
Embodiment five
Get 0.5 part of estradiol and add its solvent---in the dioxane, the ultra-high molecular weight polyethylene powder mixes that add 99.5 parts, molecular weight then and be 450 ± 500,000, diameter is 60 μ m～270 μ m evenly becomes suspension, behind the vacuum drying, promptly get pulverous composite.
Embodiment six
Get in 5 parts of Alendronate sodiums adding distilled water and dissolve, add 95 parts, molecular weight then and be 350 ± 500,000, diameter is in the ultra-high molecular weight polyethylene powder of 60 μ m～270 μ m, after being mixed into suspension, make homodisperse mixture behind the vacuum drying, put into the hot press mould then and carry out hot pressing, behind precompressed, heating, insulation, cooling four-stage, take out mould, promptly get the solid-state composite of finalizing the design.
Embodiment seven
Get 8 parts of Alendronate sodiums and add in the distilled water and dissolve, join 92 parts, molecular weight then and be 300 ± 500,000, diameter is in the ultra-high molecular weight polyethylene powder of 60 μ m～270 μ m, be mixed into suspension after, put into the hot press mould and carry out hot pressing.Behind precompressed, heating, insulation, cooling four-stage, take out mould, promptly get the solid-state composite of finalizing the design.
Embodiment eight
This example is for adopting compound artificial joint material preparation artificial joint of the present invention, and prepared artificial joint is an artificial hip joint, and its preparation method is a prior art.Fig. 1 illustrates, and the characteristics of the artificial hip joint that this is routine are: the endosexine 1 of hip cotyle is wherein made by the solid-state or pulverous ultra-high molecular weight polyethylene/medicine compound artificial joint material of above typing, and thickness is 2-4mm; 2 of the extexines of hip cotyle are that simple ultrahigh molecular weight polyethylene becomes, and thickness is 8-10mm.This hip cotyle is fitted in by prior art with other assembly of artificial hip prosthesis promptly constitutes complete artificial hip joint.
Certainly, it is whole and be regardless of inner and outer surface layers also can all to adopt ultra-high molecular weight polyethylene of the present invention/medicine compound artificial joint material to make hip cotyle, and just the hip cotyle cost that makes like this is higher.
Embodiment nine
This example is for adopting compound artificial joint material preparation artificial joint of the present invention, and prepared artificial joint is an artificial knee joint.Artificial shin vinyl disc in the artificial knee joint is made by the solid-state or pulverous ultra-high molecular weight polyethylene/medicine compound artificial joint material of above-mentioned typing, and its manufacture method is a prior art.This artificial shin vinyl disc and other assembly of artificial knee joint combined by prior art promptly constitute complete artificial knee joint.
The selected inhibition bone dissolved substance of the present invention can also be that other existingly can suppress bone dissolving and can be at 180 ℃ of not pyrolysated medicines except that clinical estradiol commonly used, Alendronate sodium.
Claims (7)
1, a kind of ultra-high molecular weight polyethylene/medicine compound artificial joint material, its component and weight proportion thereof are: 99.5～90 parts of ultra-high molecular weight polyethylenes have 0.5～10 part of the medicine that suppresses the bone dissolution.
2, a kind of ultra-high molecular weight polyethylene according to claim 1/medicine compound artificial joint material is characterized in that: described ultra-high molecular weight polyethylene is that diameter is the powder of 60 μ m～270 μ m, and its molecular weight is 2,000,000～5,000,000; Having the bone of inhibition dissolved drug is estradiol or Alendronate sodium.
3, a kind of method for preparing claim 1 or 2 described ultra-high molecular weight polyethylenes/medicine compound artificial joint material, its way is: get the ultra-high molecular weight polyethylene of described deal, the medicine with inhibition bone dissolution of the described deal of adding, behind the uniform mixing; Promptly make pulverous compound artificial joint material.
4, the method for preparing ultra-high molecular weight polyethylene/medicine compound artificial joint material according to claim 3, it is characterized in that: described ultra-high molecular weight polyethylene powder with have the medicine uniform mixing that suppresses the bone dissolution after, also use the hot press molding, promptly make the solid-state compound artificial joint material of molding.
5, according to claim 3 or the 4 described methods that prepare ultra-high molecular weight polyethylene/medicine compound artificial joint material, it is characterized in that: described ultra-high molecular weight polyethylene powder with the mixed uniformly way of medicine with inhibition bone dissolution is: the medicine that suppresses the bone dissolution that has of getting described deal adds in its solvent, the dissolving back adds the ultra-high molecular weight polyethylene powder of described deal, behind the uniform mixing, make the homodisperse suspension of medicine, vacuum drying.
6, a kind of artificial joint by claim 1 or 2 described ultra-high molecular weight polyethylenes/medicine compound artificial joint material preparation, it is characterized in that: described artificial joint is an artificial hip joint, the endosexine of hip cotyle is wherein made by described ultra-high molecular weight polyethylene/medicine combined artificial hip cotyle material, and the thickness of this endosexine is 2-4mm; The extexine of hip cotyle then becomes for ultrahigh molecular weight polyethylene, and thickness is 8-10mm.
7, a kind of artificial joint by claim 1 or 2 described ultra-high molecular weight polyethylenes/medicine compound artificial joint material preparation, it is characterized in that: described artificial joint is an artificial knee joint, and wherein artificial shin vinyl disc is made by described ultra-high molecular weight polyethylene/medicine compound artificial joint material.
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200610022227 CN100473423C (en) | 2006-11-09 | 2006-11-09 | Ultra-high-molecular-weight-polyethylene and drug complexes artificial joint material and preparation method thereof, and artificial joint prepared therefrom |
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| CN 200610022227 CN100473423C (en) | 2006-11-09 | 2006-11-09 | Ultra-high-molecular-weight-polyethylene and drug complexes artificial joint material and preparation method thereof, and artificial joint prepared therefrom |
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| CN101007184A true CN101007184A (en) | 2007-08-01 |
| CN100473423C CN100473423C (en) | 2009-04-01 |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102078227A (en) * | 2010-11-24 | 2011-06-01 | 南京理工大学 | Polyethylene artificial joint capable of improving biocompatibility and tribological property and preparation method thereof |
| CN103007353A (en) * | 2012-12-24 | 2013-04-03 | 南京理工大学 | Ultrahigh-molecular weight polyethylene composite material for artificial joint and preparation method of ultrahigh-molecular weight polyethylene composite material |
| CN104208056A (en) * | 2014-08-08 | 2014-12-17 | 苏州大学附属第一医院 | Pharmaceutical application of levodopa methyl ester hydrochloride in the treatment of periprosthetic osteolysis |
| CN105031721A (en) * | 2015-06-16 | 2015-11-11 | 江南大学 | Preparation method and application of hip joint socket |
| CN110799151A (en) * | 2017-06-23 | 2020-02-14 | 福卡斯特矫形外科公司 | Methods, systems, and devices for repairing a knee joint |
| CN112545716A (en) * | 2020-12-04 | 2021-03-26 | 中国矿业大学 | Artificial joint prosthesis with early warning function and preparation method thereof |
-
2006
- 2006-11-09 CN CN 200610022227 patent/CN100473423C/en not_active Expired - Fee Related
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102078227A (en) * | 2010-11-24 | 2011-06-01 | 南京理工大学 | Polyethylene artificial joint capable of improving biocompatibility and tribological property and preparation method thereof |
| CN103007353A (en) * | 2012-12-24 | 2013-04-03 | 南京理工大学 | Ultrahigh-molecular weight polyethylene composite material for artificial joint and preparation method of ultrahigh-molecular weight polyethylene composite material |
| CN103007353B (en) * | 2012-12-24 | 2014-08-20 | 南京理工大学 | Ultrahigh-molecular weight polyethylene composite material for artificial joint and preparation method of ultrahigh-molecular weight polyethylene composite material |
| CN104208056A (en) * | 2014-08-08 | 2014-12-17 | 苏州大学附属第一医院 | Pharmaceutical application of levodopa methyl ester hydrochloride in the treatment of periprosthetic osteolysis |
| CN104208056B (en) * | 2014-08-08 | 2016-06-08 | 苏州大学附属第一医院 | The pharmaceutical use of L-dopa methyl ester hydrochloride in treatment Periprosthetic bone dissolves |
| CN105031721A (en) * | 2015-06-16 | 2015-11-11 | 江南大学 | Preparation method and application of hip joint socket |
| CN110799151A (en) * | 2017-06-23 | 2020-02-14 | 福卡斯特矫形外科公司 | Methods, systems, and devices for repairing a knee joint |
| US11273044B2 (en) | 2017-06-23 | 2022-03-15 | Forcast Orthopedics, Inc. | Method, system, and apparatus for antibiotic dispensing knee prosthesis |
| CN112545716A (en) * | 2020-12-04 | 2021-03-26 | 中国矿业大学 | Artificial joint prosthesis with early warning function and preparation method thereof |
| CN112545716B (en) * | 2020-12-04 | 2021-11-23 | 中国矿业大学 | Artificial joint prosthesis with early warning function and preparation method thereof |
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| Publication number | Publication date |
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| CN100473423C (en) | 2009-04-01 |
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