CN106794280A - 用于骨再生的可吸收装置 - Google Patents

用于骨再生的可吸收装置 Download PDF

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CN106794280A
CN106794280A CN201580055672.5A CN201580055672A CN106794280A CN 106794280 A CN106794280 A CN 106794280A CN 201580055672 A CN201580055672 A CN 201580055672A CN 106794280 A CN106794280 A CN 106794280A
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packing elements
bone
osteanagenesis
fabric
pga
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安东尼奥·桑布瑟蒂
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
    • A61L27/18Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
    • A61L27/22Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/227Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28Materials for coating prostheses
    • A61L27/30Inorganic materials
    • A61L27/32Phosphorus-containing materials, e.g. apatite
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58Materials at least partially resorbable by the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/02Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L67/00Compositions of polyesters obtained by reactions forming a carboxylic ester link in the main chain; Compositions of derivatives of such polymers
    • C08L67/04Polyesters derived from hydroxycarboxylic acids, e.g. lactones

Abstract

用于骨再生的装置包含适于在使用期间插入患者骨中存在的腔(C)中的填充元件(2);所述填充元件(2)由PGA纤维制成。

Description

用于骨再生的可吸收装置
本发明的目的是骨再生装置。
本发明的应用在于其中需要在例如骨折之后整合患者的骨组织的情况。
实际上,在重组装骨部分之后,在断裂边缘的接合处仍可能存在必须被填充的空隙。
根据现有技术,用所谓的骨替代物来填充这样的腔(cavity)。使用以下骨替代物:粉末、糊状物或微粒形式或者其他形式的羟基磷灰石和/或硫酸三钙、含钙矿物质。
插入待填充的骨腔中的骨替代物固化,由此产生通过填充该腔而修复骨完整性的硬物质。
尽管如此,即使当固化时,这些材料也不能确保与天然骨组织相同的力学特性。
因此,即使在重组装和愈合的骨中,由骨替代物构成的部分与其余骨组织相比仍具有较低的硬度并且代表整个骨的弱化区。
在这种情况下,基于本发明的技术任务是提出克服上述现有技术缺点的骨再生装置。
特别地,本发明的目的是提供使得在生理学上、功能上和力学上完全修复患者骨的骨再生装置。
所述技术任务和所述目的通过包含所附权利要求书中一项或更多项中所述技术特征的骨再生装置实质上实现。
本发明的另一些特征和优点将由对骨再生装置的优选但并非排他性实施方案的示例性且因此非限制性的描述而更加清楚,如在附图中示出的,其中:
-图1是根据本发明的骨再生装置的示意图。
参照附图,附图标记1整体上表示根据本发明的骨再生装置。
装置1包含在使用期间插入在患者的骨“O”上存在的腔“C”中的填充元件(fillelement)2。
特别地,腔“C”可位于骨“O”本身的重组装断裂线“L”处。
填充元件2由固体可吸收材料制成。
更精确地,填充元件2由PGA纤维(聚乙交酯或聚乙醇酸)(优选均聚物)制成。PGA是高度生物相容性且可吸收的聚合物。
PGA纤维的平均吸收时间大约为一个月。
有利地,在填充元件2的吸收期间,骨组织的形成逐渐代替溶解的PGA纤维。
在填充元件2溶解的同时形成的骨组织完全填充腔“C”并且与患者骨的骨组织具有相同的性质。
因此,新形成的骨组织具有与原始骨组织相同的力学特性。
以这样的方式,用天然相容性组织填充腔并且不改变所修复骨的力学和生理学特性。
有利地,填充元件2由PGA纤维织物(fiber fabric)制成。
以这样的方式,一旦填充元件2插入在腔“C”中,织物被血液并且特别地被血浆浸渍,这有利于骨再生。
织物可通过以不同的方式织造PGA线,产生针织物(knitted fabric)、机织物(woven fabric)或非机织物(non-woven fabric)来获得。
优选地,织物为针织物,还更优选地为经编针织物(warp knitted fabric)。
在这样的情况下,织物具有能够呈现具有足够小网孔的网状构造的较粗糙表面。
详细地,织物的纬纱使得其间隙空间小于200μm、优选约160μm,对应于等于约0.02mm2的孔的平均面积。
此外,织物优选地是有纹理的以赋予其甚至更大的表面粗糙度和更大的刚度。
在第一实施方案中,填充元件2可以以使得其相对于待填充腔的形状基本上相对成形(counter-shaped)的方式成形。获得填充元件2所使用的织物具有足够的柔性以允许手术者将其弯曲从而使填充元件2在植入时相对成形。
在第二实施方案中,填充元件2是已成形的。特别地,填充元件2是已相对于待填充腔“C”相对成形的。
特别地,填充元件2可具有圆柱体、平行六面体、棱锥体或圆锥体形状,或者其可具有其他形状。
为了获得填充元件2,还可使用三维织造技术,其允许获得由PGA纤维制成的非中空实心体。
特别地,这样的技术提供织造并随后叠置合适形状的织物层,然后通过由与织物相同的材料(即,在此情况下为PGA)制成的缝合点使其彼此连接。
在获得期间,可产生完全为实心(即其中没有任何腔)的任何形状和尺寸的填充元件2。
PGA纤维的使用允许获得具有轻微压缩即可使填充元件2更好地适于待填充腔“C”的形状和/或尺寸的足够柔软度的实心体。
另外,手术者可在手术室中容易地用剪刀或手术刀切割填充元件2以使其形状和/或尺寸适于待填充的腔“C”。
本发明达到了预设的目的。
实际上,由于由PGA制成的可吸收填充元件的植入,存在填充其中插入填充元件的骨腔的骨再生过程。
如上所述,考虑到再生的骨组织等同于在其上植入装置的骨,重组装和愈合的骨的力学特性不降低。
因此,愈合过程更加完全并且不留下任何显著的后果。

Claims (6)

1.用于骨再生的装置,其包含适于在使用期间插入患者骨中存在的腔(C)中的填充元件(2);所述填充元件(2)由PGA纤维制成。
2.根据权利要求1所述的装置,其特征在于所述填充元件(2)由PGA纤维织物制成。
3.根据权利要求2所述的装置,其特征在于所述织物是针织物,优选经编针织物。
4.根据前述权利要求中任一项所述的装置,其特征在于所述填充元件(2)可相对于其中可插入所述填充元件(2)的骨腔相对成形。
5.根据前述权利要求中任一项所述的装置,其特征在于所述填充元件(2)相对于其中可插入所述填充元件(2)的骨腔相对成形。
6.根据权利要求5所述的装置,其特征在于所述填充元件(2)为圆柱体形、平行六面体形、棱锥体形或圆锥体形。
CN201580055672.5A 2014-10-14 2015-09-29 用于骨再生的可吸收装置 Pending CN106794280A (zh)

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ITMI2014A001786 2014-10-14
ITMI20141786 2014-10-14
PCT/IB2015/057438 WO2016059494A1 (en) 2014-10-14 2015-09-29 Absorbable device for bone regeneration

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EP (1) EP3206727A1 (zh)
JP (1) JP2017531487A (zh)
KR (1) KR20170066436A (zh)
CN (1) CN106794280A (zh)
AU (1) AU2015332133A1 (zh)
BR (1) BR112017007676A2 (zh)
CA (1) CA2963343A1 (zh)
EA (1) EA201790839A1 (zh)
IL (1) IL251192B (zh)
MX (1) MX2017003834A (zh)
WO (1) WO2016059494A1 (zh)

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CA2963343A1 (en) 2016-04-21
WO2016059494A1 (en) 2016-04-21
EP3206727A1 (en) 2017-08-23
JP2017531487A (ja) 2017-10-26
MX2017003834A (es) 2017-10-20
BR112017007676A2 (pt) 2017-12-19
KR20170066436A (ko) 2017-06-14
IL251192A0 (en) 2017-05-29
EA201790839A1 (ru) 2017-08-31
US20170304490A1 (en) 2017-10-26
IL251192B (en) 2021-05-31
AU2015332133A1 (en) 2017-04-20
US10383975B2 (en) 2019-08-20

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