WO2013097383A1 - Medical implant - Google Patents

Abstract

A medical implant having a composite structure is formed by combining more than two medical implant materials. The biodegradation rates of the medical implant materials are different. The medical implant materials are fitted to each other and present an intertwined composite structure to form a dense body. Each of the medical implant materials still maintains the respective biological properties and physical and mechanical properties, and is of a continuous structure. Such a structure can provide a multi-layer healing space for repair of an implanted part and win longer growth time for the normal tissue.

Description

 Medical implant component

 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.

 With the rapid development of technology and medicine, it has become a reality to make metal medical implant materials into porous metal medical implant materials, which have important and special uses for treating bone tissue trauma and femoral tissue necrosis. Such as 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. At present, 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.

As previously emphasized, as 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.

 In the prior art, 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

 It is an object of the present invention to provide a medical implant having a suitable fit for the repair support and natural healing process.

 The object of the present invention is achieved as follows: 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.

The so-called 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.

 A further preferred embodiment of the present invention is that the 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.

 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.

 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. Of course, when 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. Regardless of the fractionated deposition of different layers of medical implant material as mentioned in this paragraph; or fractionation Electroplating different layers of medical implant materials; or depositing and then electroplating; or electroplating and then depositing; or depositing and re-slurry curing; or electroplating and grouting, it is to form a dense body, more importantly to meet The maximum space defined by the outer boundary of each of the medical implant materials extending continuously in their stereoscopic direction is the same or substantially equivalent to the maximum space defined by the dense outer boundary of the three. It can be known that when the three medical implant materials form a dense body, their respective continuous structures must become "porous body supports" of other medical implant materials.

 Similarly, 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.

 A preferred embodiment of the 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.

 In summary, the beneficial effects of the present invention are as follows:

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. Provides a gradually expanding growth space for the normal growth of new bone tissue, while the growing new bone tissue replaces the biodegradable medical implant material in the pores of the non-biodegradable porous medical implant material to supplement the medical The support strength of the implant to meet the normal use requirements of the damaged part of the host.

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

 The present invention will be further described below in conjunction with the accompanying drawings and embodiments.

 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. detailed description

 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.

 Referring further to FIG. 1, 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. Composite structure.

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. When 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.

 Of course, when a porous medical implant material is used as the "porous body-supported biodegradable material layer of the medical implant, 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.

Claims

Rights request 1. A medical implant consisting of two or more medical implant materials, characterized in that: various medical implant materials have different biodegradation speeds; various medical implant materials are fitted to each other and present The interwoven composite structure constitutes a dense body; any of the medical implant materials retain their individual biological and physical mechanical properties, and each is a continuous structure.  2. The medical implant of claim 1, wherein: the dense body is interwoven with two medical implant materials in a male and female mold structure, and each medical implant material is oriented in a stereo direction thereof. The maximum space defined by the continuously extending outer boundaries is the same or substantially equivalent to the maximum space defined by the dense outer boundary formed by them.  3. The medical implant of claim 1 or 2, wherein: the two medical implant materials are non-biodegradable porous medical implant materials and biodegradable medical implant materials; wherein the porous medical implants The continuous through pores distributed over the material are completely filled with the biodegradable medical implant material to form a composite structure of the dense body.  4. The medical implant of claim 3, wherein: the non-biodegradable porous medical implant material is a porous medical metal implant material or a porous medical ceramic implant material; the degradable medical implant The material is biodegradable medical polymer material or hydroxyindole inorganic salt material. The medical implant according to claim 4, wherein: the porous medical metal implant material is porous tantalum, porous tantalum, porous titanium or porous stainless steel; the biodegradable medical polymer material is polyester, Polyorthoesters, polyanhydrides, polyamides, polycyanopropylene Acid or polyphosphazene.  6. The medical implant of claim 1, wherein: the dense body is interwoven with three complementary structures of medical implant materials, and each medical implant material continuously extends in a stereoscopic direction thereof. The maximum space defined by the outer boundary is the same or substantially equal to the maximum space defined by the dense outer boundary of the three.  7. The medical implant according to claim 1 or 6, wherein: the dense body composed of the three medical implant materials is composed of a non-biodegradable porous medical implant material and two bio-organisms. The degraded medical implant material is constructed; wherein the continuous through pores distributed on the porous medical implant material are continuously and completely filled by other biodegradable materials.  8. The medical implant according to claim 7, wherein: the porous medicine adopts a deposition method or/and a plating method; or first deposits and re-slurry and solidifies; or firstly electroplating and grouting solidification for filling until a dense body is formed. .  9. The medical implant of claim 8, wherein: the non-biodegradable porous medical implant material is a porous medical metal implant material or a porous medical ceramic implant material; the degradable medical implant The material is biodegradable medical polymer material or hydroxyindole inorganic salt material.  The medical implant according to claim 9, wherein: the porous medical metal implant material is porous tantalum, porous tantalum, porous titanium, porous stainless steel; biodegradable medical polymer material is polyester , polyorthoesters, polyanhydrides, polyamides, polycyanoacrylates or polyphosphazenes.