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CN1148407C - Polyethylene formation implant and method for making same - Google Patents

Polyethylene formation implant and method for making same Download PDF

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Publication number
CN1148407C
CN1148407C CNB991134745A CN99113474A CN1148407C CN 1148407 C CN1148407 C CN 1148407C CN B991134745 A CNB991134745 A CN B991134745A CN 99113474 A CN99113474 A CN 99113474A CN 1148407 C CN1148407 C CN 1148407C
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CN
China
Prior art keywords
polyethylene
molecular weight
hdpe
high density
implant
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
CNB991134745A
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Chinese (zh)
Other versions
CN1225373A (en
Inventor
钱云良
李海生
陆豪
张志龙
李鸿宾
范志宏
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SHANGHAI SUPERHIGH ENGINEERING PLASTIC CO., LTD.
Original Assignee
SHANGHAI SUPER HIGH ENGINEERING PLASTICS Co Ltd
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Publication date
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Priority to CNB991134745A priority Critical patent/CN1148407C/en
Publication of CN1225373A publication Critical patent/CN1225373A/en
Application granted granted Critical
Publication of CN1148407C publication Critical patent/CN1148407C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The present invention relates to a polyethylene formation implant and a making method thereof. The present invention is characterized in that the implant is processed by ultrahigh molecular weight polyethylene and high-density polyethylene by special technology, wherein an ultrahigh molecular weight polyethylene material accounts for more than 90%, and the implant has an omnibearing uniform micropore structure. Compared with the prior art, the micropore structure of the product is good for the rapid growth of the vascular tissue and the soft tissue of a human body. Thus, the implant and the human body have favorable biocompatibility. The implant has the advantages of high strength, nontoxicity, safety and reliability.

Description

Polyethylene formation implant and manufacture method thereof
The present invention relates to organic polymer material in medically application, relate in particular to polyethylene formation implant and manufacture method thereof.
Formation implant is applicable to the artificial eye that reproduces of eyeball excise postoperative, and in the surgery transplantation skull, cheekbone, mandible repairing with reproduce.Behind artificial eye and the artificial bone implant into body, except will guaranteeing excellent biological compatibility and essential mechanical strength, to guarantee that also the blood vessel of human body and soft tissue can ramps on it, so that both can organically combine.But, existing formation implant should have in the process all unsatisfactory, for example: about artificial eye, initial stage exploitation be to adopt pmma material, its smooth surface, tissue with it can't in conjunction with, therefore, this implant also can not rotate with eye muscle meat, and illusion is obvious, and easy infection, easily comes off.Developed the artificial eye (being commonly called as corallite) that adopts the calcium phosphate powder material in recent years again,,, and in use had heavy metal to separate out than great though it has certain associativity with tissue.About artificial bone, generally be to adopt silastic material or titanium alloy material, their defective is respectively that insufficient strength or consistency are poor, and all has slick defective, promptly the blood vessel of human body can't combine with it with soft tissue.According to nearest reported in literature, the U.S. has worked out the high density polyethylene(HDPE) formation implant, though it has compared very much progress with above-mentioned materials, because the high density polyethylene(HDPE) melting index is big, in the hot briquetting process, the flowability of material is big, cause intergranular pore texture distortion, thereby cause that aperture size is inconsistent, cause with the associativity of human body still not ideal enough, especially be processed into flaky dummy head's skull, its bulk strength and biocompatibility are relatively poor.
Purpose of the present invention is exactly to have defective and provide a kind of and human body to have good biocompatibility, intensity height, nontoxicity, safe and reliable polyethylene formation implant and manufacture method thereof at above-mentioned prior art.
The present invention is achieved in that
A kind of polyethylene formation thing is characterized in that: this implant by molecular-weight average greater than 1 * 10 6The ultrahigh molecular weight polyethylene(UHMWPE) particle and molecular-weight average less than 1 * 10 6The high density polyethylene(HDPE) fine powder form, wherein the ultrahigh molecular weight polyethylene(UHMWPE) particle accounts for 90%~100% (weight), the high density polyethylene(HDPE) fine powder accounts for 0~10% (weight), the ultrahigh molecular weight polyethylene(UHMWPE) particulate is of a size of 200~900 microns, the high density polyethylene(HDPE) fine powder is of a size of 5~30 microns, and this implant also has the comprehensive interconnected microvoid structure that evenly runs through.
Above-mentioned ultrahigh molecular weight polyethylene(UHMWPE) particulate molecular-weight average is 1.5 * 10 6~4.5 * 10 6Between preferable.
The molecular-weight average of above-specified high density polyethylene fine powder is 3 * 10 5~8 * 10 5Between preferable.
Above-mentioned ultrahigh molecular weight polyethylene(UHMWPE) particle accounts for 92~98% (weight), and it is 2~8% preferable that the high density polyethylene(HDPE) fine powder accounts for.
Above-mentioned ultrahigh molecular weight polyethylene(UHMWPE) particulate size is preferable between 450~850 microns.
The size of above-specified high density polyethylene fine powder is preferable between 10~30 microns.
A kind of manufacture method of polyethylene formation implant is characterized in that: at first ultrahigh molecular weight polyethylene(UHMWPE) and high density polyethylene(HDPE) are sieved, weighing; Mix in proportion then, can adopt suspension impregnation or hybrid modes such as electrostatic adhesion or mechanical stirring; To pour mould into after this mixture weighing again, and, kept 0.45~2 hour mold heated to 150 ℃~260 ℃; Last cooling die, product is taken out in the demoulding.
Compared with prior art, the present invention has the following advantages:
1. has excellent biological compatibility.Characteristics of the present invention are to adopt the matrix of superhigh molecular weight polyethylene material as formation implant, this material and common high density polyethylene(HDPE) comparison, physics, machinery and chemical property with many uniquenesses belong to thermoplasticity engineering materials category, but its melting index is near zero.Therefore, add man-hour carrying out formation implant, when being heated to molten state, its particle does not produce flow phenomenon, and coating of particles remains unchanged substantially, thereby intergranular pore dimension also keeps life size substantially, so the product that obtains has the comprehensive interconnected microvoid structure that evenly runs through, this structure is very favourable for the ramp of human vas tissue and soft tissue, and therefore, product of the present invention has excellent biological compatibility.
2. intensity height, in light weight.Added a small amount of high density polyethylene(HDPE) in the product of the present invention, when high density polyethylene(HDPE) was heated to molten state, it just became the caking agent between ultrahigh molecular weight polyethylene(UHMWPE) particle and the particle, therefore, and the intensity height of product of the present invention.In addition, superhigh molecular weight polyethylene material has microvoid structure, and density is very little, and in φ 16 augens, quality only is 1 gram, all can make the patient feel freely comfortable as artificial eye or artificial bone.
Nontoxicity, do not have the rejection property.Ultrahigh molecular weight polyethylene(UHMWPE) itself is the physiology inert material, has been used for artificial graft's organ in medical treatment, comprises artificial graft joint etc., and proving does not have any toxicity and rejection property to human body.As polyethylene formation implant,, do not find any toxicity and infection through relevant test yet.
4. safe and reliable.Especially for artificial bone, the physiology shape of patient's bone is all variant, before the operation in type implant is put into boiling water and soaks deliquescing, according to the true form size of patient's bone, carries out the secondary typing again.Implant of the present invention is because the superelevation inter-particle adhesion is well-balanced, and secondary typing back internal stress free can not be out of shape, and therefore the implantation back is safe and reliable.
Below in conjunction with embodiment, the invention will be further described:
Embodiment 1
Formula for a product: 1. molecular weight is 4 * 10 6The ultra high molecular polyethylene particle, wherein particle size be 630 microns to 900 microns 0.5 the gram, particle size be 450 microns to 630 microns 0.45 the gram.2. molecular weight is 8 * 10 5The high density polyethylene(HDPE) fine powder, fine particle size be 20~30 microns 0.05 the gram.
Working method: at first with superhigh molecular weight polyethylene material and high-density polyethylene material according to above-mentioned prescription sieve, weighing; Adopt mechanical stirring or electrostatic adhesion mode that above-mentioned two components are carried out thorough mixing in proportion then, and mixture is added shaping mould; With this mold heated to 230 ℃, kept this temperature 1 hour again; With mold cools down, the demoulding is also taken out goods at last.
Embodiment 2
Formula for a product: 1.. molecular weight is 1.8 * 10 6Ten thousand supra polymer component polyethylene particle, particle size are 450 microns to 630 microns 0.96 gram.2.. molecular weight 3 * 10 5The high density polyethylene(HDPE) fine powder, fine particle size be 5~20 microns 0.04 the gram.
Working method: at first with superhigh molecular weight polyethylene material and high-density polyethylene material according to above-mentioned prescription sieve, weighing; Adopt the mode of suspension impregnation that above-mentioned two components are mixed in proportion then and (promptly the high density polyethylene(HDPE) fine powder is mixed with suspension, again supra polymer component polyethylene particle be impregnated in this suspension, make high density material be attached to the surface of superelevation material equably).And will add shaping mould after this mixture drying; With this mold heated to 220 ℃, kept 1.5 hours again; With mold cools down, the demoulding is also taken out goods at last.
Embodiment 3
Formula for a product: molecular weight is 3 * 10 6The ultrahigh molecular weight polyethylene(UHMWPE) particle, wherein particle size be 630 microns to 900 microns 0.55 the gram, particle size be 450 microns to 630 microns 0.45 the gram.
Working method: identical with embodiment 1.

Claims (7)

1. polyethylene formation implant is characterized in that: this implant by molecular-weight average greater than 1 * 10 6The ultrahigh molecular weight polyethylene(UHMWPE) particle and molecular-weight average less than 1 * 10 6The high density polyethylene(HDPE) fine powder form, wherein the ultrahigh molecular weight polyethylene(UHMWPE) particle accounts for 90%~96% (weight), the high density polyethylene(HDPE) fine powder accounts for 4~10% (weight), the ultrahigh molecular weight polyethylene(UHMWPE) particulate is of a size of 200~900 microns, the high density polyethylene(HDPE) fine powder is of a size of 5~30 microns, and this implant also has the comprehensive interconnected microvoid structure that evenly runs through.
2. polyethylene formation implant according to claim 1 is characterized in that: ultrahigh molecular weight polyethylene(UHMWPE) particulate molecular-weight average is 1.5 * 10 6~4.5 * 10 6Between.
3. polyethylene formation implant according to claim 1 is characterized in that: the molecular-weight average of high density polyethylene(HDPE) fine powder is 3 * 10 5~8 * 10 5Between.
4. polyethylene formation implant according to claim 1 is characterized in that: the ultrahigh molecular weight polyethylene(UHMWPE) particle accounts for 92~98% (weight), and the high density polyethylene(HDPE) fine powder accounts for 2~8%.
5. polyethylene formation implant according to claim 1 is characterized in that: ultrahigh molecular weight polyethylene(UHMWPE) particulate size is between 450~850 microns.
6. polyethylene formation implant according to claim 1 is characterized in that: the size of high density polyethylene(HDPE) fine powder is between 10~30 microns.
7. the manufacture method of a polyethylene formation implant is characterized in that: at first ultrahigh molecular weight polyethylene(UHMWPE) and high density polyethylene(HDPE) are sieved, weighing; Mix in proportion then, can adopt suspension impregnation or hybrid modes such as electrostatic adhesion or mechanical stirring; To pour mould into after this mixture weighing again, and, kept 0.45~2 hour mold heated to 150 ℃~260 ℃; Last cooling die, product is taken out in the demoulding.
CNB991134745A 1999-02-11 1999-02-11 Polyethylene formation implant and method for making same Expired - Lifetime CN1148407C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CNB991134745A CN1148407C (en) 1999-02-11 1999-02-11 Polyethylene formation implant and method for making same

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CNB991134745A CN1148407C (en) 1999-02-11 1999-02-11 Polyethylene formation implant and method for making same

Publications (2)

Publication Number Publication Date
CN1225373A CN1225373A (en) 1999-08-11
CN1148407C true CN1148407C (en) 2004-05-05

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Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8298292B2 (en) 2003-04-16 2012-10-30 Howmedica Osteonics Corp. Craniofacial implant
WO2004093743A1 (en) * 2003-04-16 2004-11-04 Porex Surgical, Inc. Craniofacial implant
CN101746007B (en) * 2008-12-11 2012-05-23 上海超高工程塑料有限公司 Rotary rotational molding forming and manufacturing method for artificial eye pedestal implant
CN102167860B (en) * 2011-03-04 2013-02-13 四川大学 Preparation method of self-reinforced polyethylene blend for full-joint implantation
CN103751849A (en) * 2013-12-24 2014-04-30 四川大学 Ultrahigh molecular weight polyethylene composite material for fusible body processing of artificial joint
DE102016110500B4 (en) * 2016-06-07 2019-03-14 Karl Leibinger Medizintechnik Gmbh & Co. Kg Implant fabrication by additive selective laser sintering and implant

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Address after: 200940 Shanghai Songbao Road No. 90

Patentee after: SHANGHAI SUPERHIGH ENGINEERING PLASTIC CO., LTD.

Address before: 200940 Shanghai Songbao Road No. 90

Patentee before: Shanghai Super High Engineering Plastics Co., Ltd.

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Granted publication date: 20040505

CX01 Expiry of patent term