CN111166532A - Artificial joint and preparation method thereof - Google Patents

Artificial joint and preparation method thereof Download PDF

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Publication number
CN111166532A
CN111166532A CN201911404427.7A CN201911404427A CN111166532A CN 111166532 A CN111166532 A CN 111166532A CN 201911404427 A CN201911404427 A CN 201911404427A CN 111166532 A CN111166532 A CN 111166532A
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China
Prior art keywords
artificial joint
joint
adhesion
bone tissue
units
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CN201911404427.7A
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CN111166532B (en
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贺达
张磊
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Wuhan United Imaging Zhirong Medical Technology Co Ltd
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Wuhan United Imaging Zhirong Medical Technology Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2/30942Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/30769Special external or bone-contacting surface, e.g. coating for improving bone ingrowth madreporic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/3093Special external or bone-contacting surface, e.g. coating for improving bone ingrowth for promoting ingrowth of bone tissue

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Transplantation (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Manufacturing & Machinery (AREA)
  • Physics & Mathematics (AREA)
  • Geometry (AREA)
  • Prostheses (AREA)

Abstract

The invention relates to an artificial joint and a preparation method thereof. The artificial joint includes: a joint main body and a plurality of combining units distributed at intervals; each combination unit comprises an adhesion part for contacting with bone tissue cells and a supporting part for supporting the adhesion part on the surface of the joint main body; the end face of the adhering part connected with the supporting part is provided with a hooking part which is used for hooking bone tissue cells growing into the gap between two corresponding adjacent combination units. After the bone tissue cells grow into the gap between any two adjacent combination units by taking the adhesion parts of the combination units as adhesion points, the hooking parts of the combination units can hook the growing bone tissue cells, so that the bone tissue cells can be prevented from falling off from the surface of the joint main body, and the firm combination capability of the human bone tissue and the surface of the artificial joint can be improved.

Description

Artificial joint and preparation method thereof
Technical Field
The invention relates to the field of medical machinery, in particular to an artificial joint and a preparation method thereof.
Background
Artificial joint replacement is one of the common means for treating joint diseases. At present, in order to firmly bond the surface of the artificial joint to the bone tissue of the human body, a porous rough layer is generally formed on the surface of the artificial joint by sandblasting, or a hydroxyapatite or titanium-based bioactive material is sprayed on the surface of the artificial joint by thermal spraying to form a porous thin layer. However, the holes on the porous rough layer and the porous thin layer are easy to drop the bone tissue cells which grow in, so that the surface of the artificial joint cannot be firmly combined with the bone tissue of the human body, the artificial joint is not easy to grow in, and the artificial joint can be loosened.
Disclosure of Invention
In view of the above, it is necessary to provide an artificial joint and a method for preparing the same, which solve the problem that the porous rough layer and the porous thin layer on the surface of the artificial joint are easy to cause the cells of the bone tissue to be grown in to be exfoliated.
An artificial joint, comprising: a joint main body and a plurality of combining units distributed at intervals;
each binding unit includes: an adhesion part for contacting bone tissue cells and a support part for supporting the adhesion part on the joint main body surface;
and the end face of the adhesion part connected with the supporting part is provided with a hooking part which is used for hooking bone tissue cells growing into the gap between two corresponding adjacent combination units.
In one embodiment, the adhesion part is a flat plate structure, and corners of the flat plate structure are provided with round corners.
In one embodiment, the other end face of the adhesion part opposite to the end face connected with the support part is a curved surface.
In one embodiment, the support portion is a cylindrical structure.
In one embodiment, the hooking portion is of a channel-like configuration.
In one embodiment, the maximum diameter of the adhesion parts is 2-100 μm, and the distance between two adjacent adhesion parts is 100-400 μm;
the maximum diameter of the support part is 2-100 μm, and the total height of the support part and the adhesion part is 10-150 μm.
In one embodiment, a plurality of combination unit groups are arranged on the surface of the joint main body at intervals;
the combination units of every two adjacent combination unit groups are distributed in a staggered mode, and the heights of the combination units of every two adjacent combination unit groups are different.
A method of making an artificial joint according to any one of the preceding claims, the method comprising:
obtaining a joint body of the artificial joint;
a plurality of bonding units are arranged on the surface of the joint main body at intervals in an additive manufacturing mode.
In one embodiment, the joint body is prepared by casting or forging.
In one embodiment, the plurality of bonding units are printed on the joint body by laser melting.
After the bone tissue cells grow into the gap between any two adjacent combination units by taking the adhesion parts of the combination units as adhesion points, the hooking parts of the combination units can hook the growing bone tissue cells, so that the bone tissue cells can be prevented from falling off from the surface of the joint body; in addition, a plurality of combination units with specific sizes, structures and distribution can be printed on the surface of the joint main body by an additive manufacturing mode according to the growth characteristics of bone tissues, excellent adhesion and growth environments can be provided for bone tissue cells, and the growth of the bone tissues of a human body is facilitated. In conclusion, the artificial joint and the preparation method thereof can improve the firm bonding capability between the human bone tissue and the surface of the artificial joint and avoid the artificial joint from loosening.
Drawings
In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings needed to be used in the description of the embodiments will be briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.
FIG. 1 is a schematic structural diagram of an artificial joint according to an embodiment of the invention;
figure 2 is a cross-sectional view of an artificial joint provided in accordance with one embodiment of the invention;
FIG. 3 is a schematic structural diagram of an artificial joint according to another embodiment of the invention;
figure 4 is a cross-sectional view of an artificial joint according to another embodiment of the invention;
FIG. 5 is a schematic structural view of an artificial joint according to another embodiment of the invention;
figures 6-7 are cross-sectional views of an artificial joint according to another embodiment of the invention;
fig. 8 is a flowchart of a method for manufacturing an artificial joint according to an embodiment of the present invention.
Wherein the various reference numbers in the drawings are described below:
100-joint body, 200-joining unit, 210-adhesion part, 210 a-round corner, 220-support part, 230-hook part, 231-first side wall, 232-second side wall, 233-bottom wall.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.
It will be understood that when an element is referred to as being "secured to" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. In contrast, when an element is referred to as being "directly on" another element, there are no intervening elements present. In contrast, when an element is referred to as being "directly connected" to another element, there are no intervening elements present. The terms "vertical," "horizontal," "left," "right," and the like as used herein are for illustrative purposes only.
In the description of the present invention, it is to be understood that the terms "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "top," "bottom," "inner," "outer," and the like are used in the orientations and positional relationships indicated in the drawings for convenience in describing the present invention and for simplicity in description, and are not intended to indicate or imply that the referenced devices or elements must have a particular orientation, be constructed in a particular orientation, and be operated in a particular manner and are not to be construed as limiting the present invention.
As shown in fig. 1 to 7, an embodiment of the present invention provides an artificial joint, including: a joint body 100 and a plurality of coupling units 200 distributed at intervals; as shown in fig. 1 to 4, each of the coupling units 200 includes: an adhesion part 210 for contacting bone tissue cells and a support part 220 for supporting the adhesion part 210 on the surface of the joint body 100; the end surface of the adhesion part 210 connected to the support part 220 is provided with a hooking part 230, and the hooking part 230 is used for hooking bone tissue cells growing into a gap between two adjacent corresponding coupling units 200.
In the artificial joint, after the bone tissue cells are grown into the gap between any two adjacent coupling units 200 with the adhesive parts 210 of the coupling units 200 as the adhesive points, the hooking parts 230 of the coupling units 200 can hook the bone tissue cells, thereby preventing the bone tissue cells from falling off from the surface of the joint body 100. In conclusion, the artificial joint can improve the firm bonding capability between the human bone tissues and the surface of the artificial joint and avoid the artificial joint from loosening.
In some embodiments of the invention, each coupling unit 200 is disposed on a surface of the joint body 100 by additive manufacturing. Thus, a plurality of bonding units 200 with specific size, structure and distribution can be printed on the surface of the joint body 100 by using an additive manufacturing method according to the growth characteristics of bone tissue, and excellent adhesion and growth environment can be provided for bone tissue cells, which is beneficial to the growth of human bone tissue.
Additive Manufacturing is also called 3D printing (AM), and mainly designs model data by computer aided design software, and introduces the data into a specific printer, and uses a meltable adhesive material such as powdered metal or plastic to construct an object by heating, melting, extruding and printing layer by layer. In addition, the material of the coupling unit 200 is the same as that of the joint body 100, and both are biocompatible metals, for example, titanium metal.
Two examples are given below regarding the structure of the adhesion part 210:
in the (1) type, as shown in fig. 1 and 2, in some embodiments of the present invention, the adhesion part 210 is a flat plate structure, and corners of the flat plate structure are provided with rounded corners 210 a. As such, the rounded corners 210a may prevent the corners of the adhesive part 210 from scratching osteoclasts.
Alternatively, the adhesion part 210 may have a circular or rectangular flat plate structure.
In the (2) th mode, as shown in fig. 3 and 4, in some embodiments of the present invention, the other end surface of the adhesion part 210 opposite to the end surface connected to the supporting part 220 is a curved surface. The adhesion part 210 with such a structure is not easy to scratch osteoclast tissue cells, and can protect the osteoclast tissue cells.
In some embodiments of the present invention, as shown in fig. 1 and 7, the supporting portion 220 is a cylindrical structure.
Likewise, two examples are given below regarding the structure of the hooking portion 230:
in the (1) version, as shown in fig. 2 and 4, in some embodiments of the present invention, the hooking portion 230 is of a channel-like structure. The hooking part 230 with such a structure can save the material of the artificial joint.
Alternatively, the groove-like structure may be an annular groove, which may simplify the structure of the coupling unit 200 and facilitate the processing of the coupling unit 200.
Specifically, as shown in fig. 2 and 4, the annular groove includes: a first side wall 231, a second side wall 232, and a bottom wall 233 connected between the first side wall 231 and the second side wall 232, wherein the first side wall 231 and the second side wall 232 are distributed in sequence from inside to outside and are coaxially arranged with the supporting portion 220; the diameter of the first sidewall 231 is equal to the outer diameter of the support part 220. Wherein, if the adhesion part 210 is a flat plate structure, the second sidewalls 232 are vertically distributed (see fig. 2); if the adhesion part 210 is a bent bump structure, the second sidewall 232 is bent and distributed and (see fig. 4) intersects with the outer wall of the adhesion part 210.
Alternatively, the groove-like structure may comprise a plurality of strip-like grooves distributed in the circumferential direction.
Specifically, the plurality of strip-shaped grooves are uniformly distributed in the circumferential direction.
Specifically, each strip groove includes: the first side wall, the second side wall and the bottom wall are sequentially distributed from inside to outside; the first side wall is aligned with the outer wall of the support portion. Specifically, if the adhesion part 210 has a flat plate structure, the second sidewalls are vertically distributed; if the adhesive part 210 is a bent bump structure, the second sidewall is bent and intersects with the outer wall of the adhesive part 210.
In some embodiments of the present invention, the hooking portion 230 includes a plurality of barb-shaped protrusions distributed along the circumferential direction (2).
Specifically, the plurality of barb-shaped lugs are evenly distributed along the circumferential direction.
Specifically, each barb tab includes: a mounting section provided on a wall of the adhesion part 210 facing the joint main body 100, and a hooking section provided on an end of the mounting section remote from the support part 220, the hooking section extending toward a surface of the joint main body 100; the other end of the mounting segment is also connected to a support 220. Wherein, if the adhesion part 210 is a flat plate structure (see fig. 1), the hooking sections are vertically distributed and aligned with the adhesion part 210; if the adhesion part 210 is a curved convex block structure (see fig. 3), the hooking section is distributed in a curved manner, and the curvature of the hooking section is the same as that of the outer wall of the adhesion part 210, so that the transition between the hooking section and the outer wall of the adhesion part 210 is smooth.
In some embodiments of the invention, the maximum diameter of the adhesive 210 is 2 μm-100 μm, and may be, for example, 2 μm, 10 μm, 20 μm, 30 μm, 40 μm, 50 μm, 60 μm, 70 μm, 80 μm, 90 μm, 100 μm, etc.; the distance between two adjacent adhesion parts 210 is 100 μm-400 μm, and may be, for example, 100 μm, 150 μm, 200 μm, 250 μm, 300 μm, 350 μm, 400 μm, etc.; the maximum diameter of the support 220 is 2 μm to 100 μm, and may be, for example, 2 μm, 10 μm, 20 μm, 30 μm, 40 μm, 50 μm, 60 μm, 70 μm, 80 μm, 90 μm, 100 μm, or the like; the total height of the supporting portion 220 and the adhesion portion 210 is 10 μm-150 μm, for example, 10 μm, 30 μm, 50 μm, 70 μm, 90 μm, 110 μm, 130 μm, 150 μm, etc. The size of the joint part 200 is set in this way, so that good viscosity and growth environment can be provided for bone tissue cells, the binding capacity between the artificial joint and the bone tissue cells can be improved, the artificial joint can be prevented from loosening, and the service life of the artificial joint can be prolonged.
As shown in fig. 5 to 7, in some embodiments of the present invention, a plurality of coupling unit groups are spaced apart from each other on the surface of the joint body 200, the coupling units 200 of each two adjacent coupling unit groups are distributed in a staggered manner, and the heights of the coupling units 200 of each two adjacent coupling unit groups are different. Therefore, the combined unit 200 with the distribution mode has the same structure as the bone trabecula, is beneficial to the growth of bone tissue cells, and can further improve the combination capacity between the artificial joint and the bone tissue cells.
Optionally, the plurality of bonding unit groups may be divided into a first layer and a second layer, each of the first layer and the second layer includes a plurality of bonding unit groups sequentially distributed from inside to outside, the bonding units 200 of each layer have the same height, and each group of bonding units 200 of the second layer is located between two corresponding adjacent groups of bonding units 200 in the first layer. Optionally, the height of the bonding unit 200 of the second layer is twice that of the first layer. Alternatively, when printing the coupling unit 200 on the surface of the joint body 100, a first layer may be printed first, and then a second layer may be printed.
Another embodiment of the present invention provides a method for preparing the above artificial joint, as shown in fig. 8, the method comprising:
step S100 is to acquire a joint body 100 of the artificial joint.
Step S200, a plurality of coupling units 200 are disposed on the surface of the joint body 100 at intervals by an additive manufacturing method.
According to the preparation method, the plurality of combination units 200 with specific sizes, structures and distributions can be printed on the surface of the joint main body 100 by using an additive manufacturing mode according to the growth characteristics of the bone tissues, so that excellent adhesion and growth environments can be provided for bone tissue cells, the growth of the bone tissues of a human body is facilitated, the firm combination capability of the bone tissues of the human body and the surface of the artificial joint can be provided, and the artificial joint is prevented from loosening.
For step S100, the joint body 100 of the artificial joint may be prepared by casting or forging. The material used for the joint body 100 is a biocompatible metal, such as titanium.
In step S200, a plurality of coupling units 200 are printed on the joint body 100 by a laser melting method. The material used for the bonding element 200 is also a biocompatible metal, such as titanium, among others.
The additive manufacturing method includes laser sintering and laser melting. The laser sintering is a technique of sintering a powder compact by using laser as a heat source, and the laser melting is a technique of forming by completely melting metal powder under the heat action of a laser beam and cooling and solidifying the metal powder. Compared with laser sintering, the process for manufacturing the metal part by laser melting is simple, and the processing time of the artificial joint can be reduced.
The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims (10)

1. An artificial joint, characterized in that it comprises: a joint main body (100) and a plurality of connecting units (200) distributed at intervals;
each binding unit (200) comprises: an adhesion part (210) for contacting bone tissue cells and a support part (220) for supporting the adhesion part (210) on the surface of the joint body (100);
the end face of the adhering part (210) connected with the supporting part (220) is provided with a hooking part (230), and the hooking part (230) is used for hooking bone tissue cells growing into a gap between two corresponding adjacent combination units (200).
2. An artificial joint according to claim 1, wherein the adhesion portion (210) is a flat plate structure and corners of the flat plate structure are provided with rounded corners (210 a).
3. The artificial joint according to claim 1, wherein the other end surface of the adhesion part (210) opposite to the end surface connected to the support part (220) is a curved surface.
4. An artificial joint according to claim 1, wherein the support part (220) is a cylindrical structure.
5. An artificial joint according to any one of claims 1 to 4, wherein the hooking portion (230) is of a channel-like configuration.
6. The artificial joint according to any one of claims 1 to 4, wherein the maximum diameter of the adhesion parts (210) is 2 μm to 100 μm, and the distance between two adjacent adhesion parts (210) is 100 μm to 400 μm;
the maximum diameter of the support part (220) is 2 μm to 100 μm, and the total height of the support part (220) and the adhesion part (210) is 10 μm to 150 μm.
7. The artificial joint according to any one of claims 1 to 4, wherein a plurality of binding unit groups are arranged on the surface of the joint main body (100) at intervals;
the combination units (200) of every two adjacent combination unit groups are distributed in a staggered mode, and the heights of the combination units (200) of every two adjacent combination unit groups are different.
8. A method of manufacturing an artificial joint according to any one of claims 1 to 7, comprising:
obtaining a joint body (100) of the artificial joint;
a plurality of bonding units (200) are arranged on the surface of the joint main body (100) at intervals by using an additive manufacturing mode.
9. Method for producing according to claim 8, characterized in that the joint body (100) is produced by casting or forging.
10. The production method according to claim 8 or 9, characterized in that the plurality of bonding units (200) are printed on the joint body (100) by means of laser melting.
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CN107252366A (en) * 2017-01-16 2017-10-17 吴栋 A kind of joint prosthesis metal outer cup and preparation method thereof
CN107252365A (en) * 2017-01-16 2017-10-17 吴栋 A kind of joint prosthesis femoral prosthesis and preparation method thereof
CN110621356A (en) * 2017-03-21 2019-12-27 国际商业机器公司 Antimicrobial medical implant surfaces

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US20060200062A1 (en) * 2000-12-20 2006-09-07 Usgi Medical Inc. Multi-barbed device for retaining tissue in apposition and methods of use
US20050203637A1 (en) * 2003-11-10 2005-09-15 Edman Carl F. Structures and devices for parenteral drug delivery and diagnostic sampling
CN1820728A (en) * 2006-01-26 2006-08-23 上海交通大学 Composite system implant unit for maxillofacial bone
US20110021965A1 (en) * 2007-11-19 2011-01-27 Massachusetts Institute Of Technology Adhesive articles
US20120165937A1 (en) * 2009-09-04 2012-06-28 Sofradim Production Fabric with barbs coated with a water-soluble material
CN102883687A (en) * 2010-04-29 2013-01-16 芬斯贝利(发展)有限责任公司 Prosthesis
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CN106137463A (en) * 2015-05-13 2016-11-23 贺利氏医疗有限公司 The bone alternate material of plane and the method manufacturing open-porous body
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CN107252366A (en) * 2017-01-16 2017-10-17 吴栋 A kind of joint prosthesis metal outer cup and preparation method thereof
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