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WO2013097383A1 - Implant médical - Google Patents

Implant médical Download PDF

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Publication number
WO2013097383A1
WO2013097383A1 PCT/CN2012/074513 CN2012074513W WO2013097383A1 WO 2013097383 A1 WO2013097383 A1 WO 2013097383A1 CN 2012074513 W CN2012074513 W CN 2012074513W WO 2013097383 A1 WO2013097383 A1 WO 2013097383A1
Authority
WO
WIPO (PCT)
Prior art keywords
medical implant
medical
porous
biodegradable
materials
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.)
Ceased
Application number
PCT/CN2012/074513
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English (en)
Chinese (zh)
Inventor
叶雷
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.)
CHONGQING RUNZE MEDICAL INSTRUMENTS CO Ltd
Original Assignee
CHONGQING RUNZE MEDICAL INSTRUMENTS CO Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by CHONGQING RUNZE MEDICAL INSTRUMENTS CO Ltd filed Critical CHONGQING RUNZE MEDICAL INSTRUMENTS CO Ltd
Publication of WO2013097383A1 publication Critical patent/WO2013097383A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L27/42—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having an inorganic matrix
    • A61L27/427—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having an inorganic matrix of other specific inorganic materials not covered by A61L27/422 or A61L27/425
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

Definitions

  • the present invention relates to a medical implant material, and more particularly to a medical implant having a composite structure. Background technique
  • Medical implant material refers to a special type of medical consumable material that is planted, buried, fixed in the damaged or diseased part of the host, supports, repairs, and replaces its function. It is a kind of special performance and function for artificial organ reconstruction. , surgical repair, physical therapy rehabilitation, disease diagnosis and treatment, materials that have no adverse effects on human tissues and blood.
  • Medical implant materials can be classified according to the application site of materials, such as hard tissue materials such as bone, cartilage, and teeth. Among them, hard tissue materials for orthopedics are important medical implant materials.
  • Medical implant materials can also be classified according to their biodegradability, such as biodegradable medical implant materials and non-biodegradable medical implant materials; and different biodegradable medical implant materials, which are implanted in the host.
  • the rate of biodegradation is usually different, both fast and slow.
  • Medical implant materials can be roughly classified into metals, ceramics and polymers according to the material itself.
  • As a replacement material for heavy-duty hard tissues such as knee joints, myeloid joints, fracture fixations and artificial bones, metals, ceramics and polymers have their own advantages and disadvantages; so far, for reasons of strength and safety, bioceramics and humans And animal bone derivatives, etc.
  • the coating or the second phase imparts a certain biocompatibility and biological activity to the metal, and since the metal material has high mechanical strength and excellent fatigue properties which cannot be compared with other materials, it is still the most widely used biological force in clinical practice. material.
  • porous metal medical implant materials which have important and special uses for treating bone tissue trauma and femoral tissue necrosis.
  • porous metal stainless steel, porous metal titanium, porous metal ruthenium, porous metal ruthenium, porous magnesium zinc, etc. they are used as porous implant materials for the treatment of bone tissue trauma and femoral tissue necrosis, and their porosity should be 30 ⁇ 80%, pores All connected and evenly distributed, so that it is consistent with the growth of human bone tissue, and should minimize the weight of the material itself, suitable for human implant use.
  • the refractory metal bismuth and bismuth can be made into a physical structure with a high uniformity of the hook and the physical properties of the human body, and gradually become an important connecting component for ensuring the normal growth of the new bone tissue.
  • a hard tissue implant material for orthopedics in addition to having certain biocompatibility and biological activity, it also needs physical and mechanical properties compatible with the human body to achieve corresponding connection support in the implanted human body. Strength; more importantly, it needs to have a high uniform distribution of connected pores to ensure normal growth space and repair time of the new bone tissue. As medical implants, these requirements are contradictory. To provide more normal growth space for new bone tissue, the implant material should have more connected pores; and as the porosity of the implant material increases. The physical and mechanical properties such as its supporting strength often fail to reach other relevant properties required for human body implantation. In general, the implanted space of the damaged part of the human body is very limited, and the implant must satisfy both physical and mechanical properties and higher porosity.
  • the porous medical implant material provides normal bone tissue for a limited amount of implantation space. Growing The space is basically determined by the porosity of the implant material.
  • a biomedical implant material is also used as a base layer to solve the support strength, and another biomedical implant material is coated thereon to impart a certain biocompatibility and biological activity, and their mutual binding sites. Only a face-to-face combination, the medical implant of this composite structure still does not match well with the natural healing process of the damaged host, and is not conducive to host damage or repair of the lesion. Summary of the invention
  • a medical implant which is composed of two or more medical implant materials, characterized in that: various medical implant materials have different biodegradation speeds; various medical treatments
  • the composite material in which the implant materials are intermingled and interlaced constitutes a dense body; any of the medical implant materials retain their individual biological and physical mechanical properties, and each is a continuous structure.
  • the reason why the invention features the medical implant material with different biodegradation speed is to provide a multi-level healing space for the repair of the implant site, and to give the normal tissue a longer growth time, which is actually a medical implant.
  • the implantation space in which the biodegradation of the material is gradually removed is exchanged for the longer growth time of the normal tissue, which is more suitable for the natural healing process of the damaged host implantation site.
  • a preferred solution of the present invention is to use two medical implant materials having different biodegradation speeds to form a corresponding dense body, that is, the dense body is made of two medical implant materials to each other.
  • the male mold structure is interwoven, and the maximum space defined by the outer boundary of each medical implant material that extends continuously in its three-dimensional direction is the same or substantially equivalent to the maximum space defined by the dense outer boundary formed by them.
  • the male and female mold structures mentioned herein can be visually understood as the medical implant materials of the two self-contained continuous structures being a "chiral structure" with each other, and they are not a single male and female mold structure combined with one side, and It is a relatively complicated interlaced interlaced surface, which is a dense body of each other's support body.
  • the first aspect of the present invention is easy to manufacture, and the second is composed of two medical implant materials which are continuous bodies.
  • the dense body is also more likely to meet the support strength requirements of the implant site, and it can provide two healing spaces in the same implant space due to the different degradation speeds, which is more conducive to the repair of the damaged host.
  • biodegradation rate refers to the rate of biodegradation of medical implant materials in the implanted host; the medical implant material with different biodegradation speeds can refer to the biodegradation rate of the medical implant material used in the implanted host. It is fast or slow, but it can also be an extreme situation, one of which is a non-biodegradable medical implant material, and the other is a biodegradable medical implant material.
  • the two preferred medical implant materials of the present invention are a non-biodegradable porous medical implant material, and the other is a biodegradable medical implant material; such a non-biodegradable porous medical implant material is present It is readily available in the art, and the segment is also easily filled with a biodegradable medical implant material to completely fill the composite structure constituting the dense body. Obviously, both medical implant materials retain their individual biological and physical mechanical properties, and are each a continuous structure; it is clear that the pores of the porous medical implant material are filled with another medical implant material. Another void in the dense body that is a continuous structural medical implant material is also a porous medical implant material that is a continuous structure.
  • the filling that is, the pores of the two are continuously filled with each other so that the maximum space defined by the outer boundary of each medical implant material extending continuously in its three-dimensional direction is the same as or substantially the largest space defined by the dense outer boundary formed by them. It is also quite easy to implement.
  • non-biodegradable porous medical implant material is a porous medical metal implant material or a porous medical ceramic implant material;
  • the degradable medical implant material is a biodegradable medical polymer material or Hydroxyl-based inorganic salt material.
  • porous medical metal implant material is, for example, porous tantalum, porous tantalum, porous titanium or porous stainless steel.
  • Biodegradable medical polymer materials are polyesters, polyorthoesters, polyanhydrides, polyamides, polycyanoacrylates or polyphosphazenes.
  • the medical implant provided by the invention may also be a compact body formed by three medical implant materials with different biodegradation speeds and fully intertwined and interlaced composite structures, and the three medical implant materials in the compact body are complementary.
  • the structure is interwoven and the maximum space defined by the outer boundary of each medical implant material extending continuously in its three-dimensional direction is the same as or substantially equivalent to the maximum space defined by the dense outer boundary of the three.
  • the dense body composed of three medical implant materials is preferably composed of a non-biodegradable porous medical implant material and two other biodegradable medical implant materials; the materials are respectively deposited or/and plated. Filling is performed until a dense body is formed.
  • a porous medical implant material is used as a "porous body support" degradation layer of a medical implant, another layer of biodegradable material is filled with grouting until a dense body is formed.
  • one of the three medical implant materials preferably a non-biodegradable porous medical implant material, is a porous medical metal implant material or a porous medical ceramic implant material; the degradable medical implant material is bio Degradation of medical polymer materials or hydroxyindole inorganic salt materials.
  • porous medical metal implant material is, for example, porous tantalum, porous tantalum, porous titanium, porous magnesium zinc or porous stainless steel.
  • Biodegradable medical polymer materials are polyesters, polyorthoesters, polyanhydrides, polyamides, polycyanoacrylates or polyphosphazenes.
  • the non-biodegradable porous metal medical implant material or the porous medical ceramic material currently reported on the market or in the literature may be selected from the medical implants of the present invention, and the porous medical implant materials have continuous through pores to satisfy the human body. Implantation requirements, the degradable medical polymer material is melted and filled and re-sintered according to the prior art; or the implant is prepared according to the prior art deposition method or/and electroplating method. Become feasible.
  • Non-biodegradable porous medical implant selected for use in the above medical implants
  • Materials and other biodegradable medical implant materials which maintain their biological and physical and mechanical properties, meet the requirements for medical implants. Due to the compact structure of the composite structure in which they are intertwined with each other, the mechanical strength is higher than that of the pure porous medical implant material; and the porosity of the porous medical implant material can be obtained under the same mechanical strength. Once again, the strength reduction due to the increased porosity can be reinforced or enhanced by additional biodegradable medical implant materials filled therein.
  • Such a medical implant can provide a larger growth space for new bone tissue to the host than the prior art implant material in the same implant space, with biodegradation of the biodegradable medical implant material.
  • the medical implant according to the present invention provides repair to the host in the same implantation space as compared with the conventional metal surface coating or the composite implant material composed of two kinds of medical implant materials. Time and space are longer and bigger. If a composite structure of two or more medical implant materials is used to fit or stack, the mutual independence of the implant determines that the implant volume of the implant is defined by the outer end of the extension of various medical implant materials. The sum of the volumes, although these implants provide the host with two reserved spaces for normal tissue growth due to their different biodegradation rates, they require more implantation space to provide normal tissue. The same repair time as the product of the present invention. DRAWINGS
  • Embodiment 1 is a schematic structural view of Embodiment 1 of the present invention.
  • Figure 2 is a schematic structural view of Embodiment 2 of the present invention.
  • Figure 3 is an enlarged view of a portion A in Figure 2.
  • Embodiment 1 Referring to FIG. 1 , a medical implant is composed of two medical implant materials. The biodegradation speeds of the two medical implant materials are different, and they are intertwined and interlaced.
  • the structure constitutes a uniform dense body; any of the medical implant materials retain their individual biological and physical mechanical properties, and each is a continuous structure.
  • the medical implant material and the medical implant material are interwoven with each other in a male and female mold structure to form a dense body, and the maximum space defined by the outer boundary of each medical implant material continuously extending in a stereoscopic direction thereof and the same are formed.
  • the dense outer boundary defined by the outer boundary is the same.
  • the two medical implant materials of this example are non-biodegradable porous medical implant materials (such as porous medical metal implant materials, porous medical ceramic implant materials) and biodegradable medical polymer materials (polyester, poly-origin) An acid ester, a polyanhydride, a polyamide, a polycyanoacrylate or a polyphosphazene.
  • the continuous through pores distributed on the porous medical implant material 1 are completely filled with the biodegradable medical polymer material 2 to constitute the dense body.
  • the porous medical metal implant material of the present invention may be porous as known in the art. Niobium, porous tantalum, porous titanium or porous stainless steel, etc.
  • the porous medical metal implant material is used as the "porous body support" of the medical implant of the present invention, the other biodegradable medical polymer material is made into a molten shape, and can be filled and filled by the prior art grout.
  • Example 2 Referring to Fig. 2, a medical implant, which is a chiseled dense body composed of three medical implant materials having different biodegradation speeds; any medical implant material still retains its Alone biological and physical and mechanical properties, and self-contained as a continuous structure.
  • the medical implant material 1 in the dense body is interwoven with the complementary structure of the medical implant material 2 and the medical implant material 3, and the maximum space defined by the outer boundary of each medical implant material continuously extending in a stereoscopic direction thereof
  • the maximum external space defined by the dense outer boundary of the three complements is the same.
  • Three medical implant materials one of which is a non-biodegradable porous medical implant material 1 and two other biodegradable medical implant materials 2 and 3; wherein the porous medical implant material 1 is continuously continuous
  • the pores are filled by other biodegradable medical polymer materials by deposition or/and plating, respectively, until a dense body is formed.
  • the grouting cure is used to fill another biodegradable material layer until a dense body is formed.
  • the porous medical implant material is a porous medical metal implant material or a porous medical ceramic implant material; the degradable medical implant material is a biodegradable medical polymer material or a hydroxyindole inorganic salt material.
  • a preferred embodiment of the porous medical metal implant material is, for example, porous tantalum, porous tantalum, porous titanium or porous stainless steel.
  • Biodegradable medical polymer materials are polyesters, polyorthoesters, polyanhydrides, polyamides, polycyanoacrylates or polyphosphazenes.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Dermatology (AREA)
  • Dispersion Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Composite Materials (AREA)
  • Materials Engineering (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un implant médical présentant une structure composite, formé par la combinaison de plus de deux matériaux d'implant médical. Les vitesses de biodégradation des matériaux d'implant médical sont différentes. Les matériaux d'implant médical sont adaptés l'un à l'autre et présentent une structure composite entrelacée pour former un corps dense. Chacun des matériaux d'implant médical conserve encore ses propriétés biologiques et ses propriétés physiques et mécaniques respectives, et se présente sous forme d'une structure continue. Une telle structure peut fournir un espace de cicatrisation multicouche destiné à la réparation d'une partie implantée et donne un temps de croissance plus long au tissu normal.
PCT/CN2012/074513 2011-12-26 2012-04-23 Implant médical Ceased WO2013097383A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201110440393.4A CN103170013B (zh) 2011-12-26 2011-12-26 一种医用植入件
CN201110440393.4 2011-12-26

Publications (1)

Publication Number Publication Date
WO2013097383A1 true WO2013097383A1 (fr) 2013-07-04

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PCT/CN2012/074513 Ceased WO2013097383A1 (fr) 2011-12-26 2012-04-23 Implant médical

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CN (2) CN103170013B (fr)
WO (1) WO2013097383A1 (fr)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3233180B1 (fr) 2014-12-18 2020-01-29 Cardiac Pacemakers, Inc. Interface de jonction fibreuse entre structures
CN107198600A (zh) * 2016-03-18 2017-09-26 重庆润泽医药有限公司 一种椎体间脊柱植入体
CN106267361A (zh) * 2016-08-29 2017-01-04 上海交通大学 一种医用可载药金属‑高分子梯度多孔复合材料
CN109893304B (zh) * 2019-04-16 2021-03-23 南京医科大学附属逸夫医院 一种特定形态与结构的3d打印组织工程支架

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CN101007183A (zh) * 2006-12-01 2007-08-01 华南理工大学 一种原位成孔自固化磷酸钙复合组织工程支架的制备方法
WO2008017170A1 (fr) * 2006-08-10 2008-02-14 Ao Technology Ag Matériau polymère biomédical pour réparation et réalisation de tissu
CN101474428A (zh) * 2009-01-16 2009-07-08 浙江普洛医药科技有限公司 聚酯增强可降解多孔硅酸钙复合支架材料、制备及用途
CN101983728A (zh) * 2010-11-09 2011-03-09 厦门大学 贝壳多孔羟基磷灰石基骨修复材料及其制备方法

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KR101289122B1 (ko) * 2008-03-18 2013-07-23 한국보건산업진흥원 생체분해성 마그네슘계 합금으로 다공성 구조체의 기공이충진된 복합재 임플란트 및 이의 제조방법
CN101906549B (zh) * 2010-08-17 2012-11-21 南京航空航天大学 基于多孔泡沫金属的嵌入式固体自润滑材料及其制备方法

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CN1739812A (zh) * 2005-09-16 2006-03-01 哈尔滨工程大学 TiO2增强聚甲基丙烯酸羟乙酯骨组织支架及其制备方法
WO2008017170A1 (fr) * 2006-08-10 2008-02-14 Ao Technology Ag Matériau polymère biomédical pour réparation et réalisation de tissu
CN101007183A (zh) * 2006-12-01 2007-08-01 华南理工大学 一种原位成孔自固化磷酸钙复合组织工程支架的制备方法
CN101474428A (zh) * 2009-01-16 2009-07-08 浙江普洛医药科技有限公司 聚酯增强可降解多孔硅酸钙复合支架材料、制备及用途
CN101983728A (zh) * 2010-11-09 2011-03-09 厦门大学 贝壳多孔羟基磷灰石基骨修复材料及其制备方法

Also Published As

Publication number Publication date
CN104383602A (zh) 2015-03-04
CN103170013B (zh) 2014-12-24
CN103170013A (zh) 2013-06-26
CN104383602B (zh) 2016-03-23

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