WO2020114252A1 - 趾关节假体及其制作方法 - Google Patents

趾关节假体及其制作方法 Download PDF

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Publication number
WO2020114252A1
WO2020114252A1 PCT/CN2019/119617 CN2019119617W WO2020114252A1 WO 2020114252 A1 WO2020114252 A1 WO 2020114252A1 CN 2019119617 W CN2019119617 W CN 2019119617W WO 2020114252 A1 WO2020114252 A1 WO 2020114252A1
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WO
WIPO (PCT)
Prior art keywords
medullary
needle
prosthesis
toe joint
structure layer
Prior art date
Application number
PCT/CN2019/119617
Other languages
English (en)
French (fr)
Inventor
史春宝
许奎雪
卢小强
董泽宇
史文超
解凤宝
王振国
Original Assignee
北京市春立正达医疗器械股份有限公司
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
Priority to US17/257,524 priority Critical patent/US20210145596A1/en
Application filed by 北京市春立正达医疗器械股份有限公司 filed Critical 北京市春立正达医疗器械股份有限公司
Priority to JP2020568473A priority patent/JP7112526B2/ja
Priority to AU2019394476A priority patent/AU2019394476B2/en
Priority to EP19894168.4A priority patent/EP3791829A4/en
Publication of WO2020114252A1 publication Critical patent/WO2020114252A1/zh
Priority to ZA2020/07947A priority patent/ZA202007947B/en

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    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30943—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using mathematical models
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30948—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using computerized tomography, i.e. CT scans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/30971—Laminates, i.e. layered products
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/30985—Designing or manufacturing processes using three dimensional printing [3DP]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/42—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
    • A61F2/4225—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for feet, e.g. toes
    • A61F2002/4233—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for feet, e.g. toes for metatarso-phalangeal joints, i.e. MTP joints
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/42—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
    • A61F2/4241—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for hands, e.g. fingers
    • A61F2002/4251—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for hands, e.g. fingers for metacarpo-phalangeal joints, i.e. MCP or MP joints, e.g. knuckle joints
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0023—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in porosity

Definitions

  • the invention relates to the technical field of medical prostheses, in particular to a toe joint prosthesis and a manufacturing method thereof.
  • Toe joint prosthesis is a surgical implant used in toe joint replacement surgery to replace the toe joint area of human patients.
  • the human toe joint needs to be repaired due to a tumor or comminuted fracture, it is often easy to cause serious bone defects in the toe joint.
  • the severe bone defect not only makes the toe joint's osteotomy position bearing capacity worse, but also easy It leads to problems such as the defect of the attachment point of the muscle at the toe joint or the damage of the joint capsule.
  • the existing toe joint prosthesis is mainly composed of two parts: a first medullary prosthesis and a second medullary prosthesis.
  • the first medullary prosthesis and the second medullary prosthesis are hinged to realize the activity of the toe joint prosthesis Features.
  • the first toe joint prosthesis of the existing toe joint prosthesis cannot be effectively fixed to the osteotomy segment of the affected area; on the other hand, the toe joint prosthesis cannot be reconstructed more effectively.
  • the attachment point of the nearby muscles and the joint capsule cannot guarantee the stability of the toe joint prosthesis after implantation, which is not conducive to the patient's postoperative rehabilitation and even easily causes secondary injury to the patient.
  • the present invention proposes a toe joint prosthesis and a manufacturing method thereof.
  • the toe joint prosthesis according to the present invention includes: a first medullary needle prosthesis and a second medullary needle prosthesis hinged to the first medullary needle prosthesis.
  • the first medullary needle prosthesis includes a first A medullary needle and a second medullary needle connected to the first medullary needle and located outside the medullary cavity, the second medullary needle is hinged to the second medullary needle prosthesis, wherein the first medullary needle and/or the second medullary needle and/or The outer surface of the second medullary prosthesis is formed with a three-dimensional porous structure layer.
  • the toe joint prosthesis is a toe joint prosthesis, wherein the first medullary needle prosthesis is used to connect with the metatarsal bone, and the second medullary needle prosthesis is used to connect with the phalanx, and the first medullary needle prosthesis is located inside the medullary cavity of the metatarsal bone.
  • the two-medullary needle is located outside the medullary cavity of the metatarsal bone and abuts the end surface of the metatarsal bone.
  • the toe joint prosthesis is a metatarsophalangeal joint prosthesis, wherein the first medullary needle prosthesis is used to connect with the metacarpal bone, the second medullary needle prosthesis is used to connect with the phalanx, and the first medullary needle prosthesis is located inside the medullary cavity of the metacarpal bone.
  • the second medullary needle is located outside the medullary cavity of the metacarpal bone and abuts the end surface of the metacarpal bone.
  • the three-dimensional porous structure layer includes a plurality of wire diameters and a plurality of pores formed by intersecting the plurality of wire diameters, each pore is interconnected, and the average diameter of each pore is different, wherein the average diameter of each pore is in the range of 100 ⁇ m Up to 400 ⁇ m, and the porosity of the three-dimensional porous structure layer ranges from 50% to 80%.
  • the average diameter of each pore formed in the three-dimensional porous structure layer on the outer surface of the first medullary needle is larger than the average diameter of each pore formed in the three-dimensional porous structure layer on the outer surface of the second medullary needle.
  • the first medullary prosthesis further includes a hinge joint fixedly connected to the second medullary prosthesis, an end of the articulated joint facing the second medullary prosthesis is configured as a spherical surface, and the second medullary prosthesis includes a spherical recess and a spherical shape The end surface of the recess facing the hinge joint is configured as a concave spherical surface that cooperates with a spherical surface.
  • the second prosthetic needle prosthesis further includes a needle-shaped portion connected to the spherical concave portion, and the spherical concave portion further includes an outwardly protruding curved surface connected between the concave spherical surface and the outer peripheral wall of the needle-shaped portion, a three-dimensional porous structure The layer is formed on the curved surface.
  • the curved surface of the spherical recess includes a first surface extending into the medullary cavity and a second surface located outside the medullary cavity, wherein the average diameter of each pore of the three-dimensional porous structure layer formed on the first surface It is larger than the average diameter of each pore in the three-dimensional porous structure layer formed on the second surface.
  • the average diameter of each pore of the three-dimensional porous structure layer formed on the first surface ranges from 100 ⁇ m to 200 ⁇ m
  • the average diameter of each pore in the three-dimensional porous structure layer formed on the second surface ranges from 200 ⁇ m to 400 ⁇ m.
  • the side wall of the second medullary needle is also formed with a first suture hole penetrating the second medullary needle, and the end of the hinge joint close to the second medullary needle is formed with a second suture hole penetrating the hinge joint.
  • the outer surface of the needle-shaped portion is configured as a rough surface.
  • first medullary needle, the second medullary needle and the porous three-dimensional structure layer are integrally formed, and/or, the second medullary needle prosthesis and the porous three-dimensional structure layer are integrally formed.
  • the manufacturing method of the toe joint prosthesis according to the present invention includes the following steps:
  • a three-dimensional porous structure layer is formed on the outer surface of the first medullary needle and/or the second medullary needle and/or the second medullary needle prosthesis;
  • the first medullary needle is arranged in the bone marrow cavity
  • the second medullary needle is arranged outside the bone marrow cavity
  • the first medullary needle and the second medullary needle are connected to form a first medullary needle prosthesis
  • the toe joint prosthesis is a toe joint prosthesis, wherein the first medullary needle prosthesis is used to connect with the metatarsal bone, and the second medullary needle prosthesis is used to connect to the phalanx, and the first marrow
  • the needle is located inside the medullary cavity of the metatarsal bone, and the second medullary needle is located outside the medullary cavity of the metatarsal bone and abuts the end surface of the metatarsal bone.
  • the toe joint prosthesis is a metacarpal toe joint prosthesis, wherein the first medullary needle prosthesis is used to connect with the metacarpal bone, and the second medullary needle prosthesis is used to connect with the phalanx, and the first The medullary needle is located inside the medullary cavity of the metacarpal bone, and the second medullary needle is located outside the medullary cavity of the metacarpal bone and abuts the end surface of the metacarpal bone.
  • the specific step of forming a three-dimensional porous structure layer on the outer surface of the first medullary needle and/or the second medullary needle and/or the second medullary needle prosthesis includes:
  • micro-CT to three-dimensionally scan the first and/or second medullary needle prosthesis, and use MIMICS to reconstruct the scanned data to obtain a three-dimensional schematic model
  • the three-dimensional schematic model is divided into regions, and the divided regions are adapted to different growth requirements of the same organization, and the diameter of the pores in each region is further adjusted so that different regions have different porosities;
  • 3D printing equipment is used to generate a solid model of the first and/or second medullary needle prosthesis, and the surface of the wire diameter in the generated solid model is adjusted by adjusting the focus parameter of the 3D printing equipment Multiple protrusions are formed, where the value of the focus offset parameter ranges from 5.8mA to 6.2mA.
  • the average diameter of each pore in the three-dimensional porous structure layer formed on the outer surface of the first medullary needle is larger than that in each of the three-dimensional porous structure layer formed on the outer surface of the second medullary needle The average diameter of the pores.
  • the first prosthetic needle prosthesis further includes a hinge joint fixedly connected to the second prosthetic needle, an end of the hinge joint facing the second prosthetic prosthesis is configured as a spherical surface, and the first The two-medullary prosthesis includes a spherical concave portion, and an end surface of the spherical concave portion facing the hinge joint is configured as a concave spherical surface that cooperates with the spherical surface.
  • the second medullary needle prosthesis further includes a needle-shaped portion connected to the spherical concave portion, and the spherical concave portion further includes a direction connected between the concave spherical surface and the outer peripheral wall of the needle-shaped portion An outwardly protruding arc surface, the three-dimensional porous structure layer is formed on the arc surface.
  • the curved surface of the spherical recess includes a first surface extending into the medullary cavity and a second surface located outside the medullary cavity, wherein each of the three-dimensional porous structure layers formed on the first surface The average diameter of the pores is larger than the average diameter of each pore in the three-dimensional porous structure layer formed on the second surface.
  • the average diameter of each pore of the three-dimensional porous structure layer formed on the first surface ranges from 100 ⁇ m to 200 ⁇ m
  • the average diameter of each pore of the three-dimensional porous structure layer formed on the second surface is The range is 200 ⁇ m to 400 ⁇ m.
  • a side wall of the second medullary needle is further formed with a first suture hole penetrating the second medullary needle, and an end of the hinge joint close to the second medullary needle is formed therethrough The second suture hole of the hinge joint.
  • the outer surface of the needle-shaped portion is configured as a rough surface.
  • first medullary needle, the second medullary needle and the porous three-dimensional structure layer are integrally formed, and/or, the second medullary needle prosthesis is integrally formed with the porous three-dimensional structure layer.
  • the toe joint prosthesis of the present invention has the following advantages:
  • the outer surface of the first prosthesis needle and/or the second prosthesis needle is obtained Better bone ingrowing ability and bone crawling ability, which makes the fixation of the toe joint prosthesis more stable.
  • the arrangement of the three-dimensional porous structure layer can also effectively reduce the weight of the toe joint prosthesis and help to rebuild the attachment points of soft tissues and muscles, which can effectively reduce the recovery time of the patient after surgery and greatly improve the patient's postoperative Recovery effect.
  • the first medullary needle prosthesis and the second medullary needle prosthesis of the toe joint prosthesis of the present invention can not only be more suitable for the inner diameter and bending curvature of the patient's medullary cavity, thereby further strengthening the toe joint prosthesis
  • the stability of the toe joint can also help to restore the length of the toe joint, thereby ensuring that the length of the patient's affected toe joint is consistent with the length of the healthy toe joint.
  • the arrangement of the first suture hole and the second suture hole also helps to repair or reconstruct the damaged joint capsule, thereby facilitating the postoperative recovery of the patient.
  • FIG. 1 is a schematic structural diagram of a toe joint prosthesis according to the present invention.
  • FIG. 2 is a schematic diagram of the connection of the toe joint prosthesis shown in FIG. 1 to the metatarsal and phalanx;
  • FIG. 3 is a schematic structural view of the first prosthetic needle prosthesis shown in FIG. 1;
  • FIG. 4 is a schematic structural view of the hinge joint shown in FIG. 3;
  • FIG. 5 is a schematic structural diagram of the second prosthetic needle prosthesis shown in FIG. 1.
  • FIG. 1 shows the structure of a toe joint prosthesis 100 according to the present invention.
  • the toe joint prosthesis 100 includes: a first medullary needle prosthesis 1 and a second medullary needle prosthesis 2 articulated with the first medullary needle prosthesis 1.
  • the first medullary needle prosthesis 1 includes A first medullary needle 11 provided in the bone marrow cavity and a second medullary needle 12 connected to the first medullary needle 11 and located outside the medullary cavity, the second medullary needle 12 is hinged with the second medullary needle prosthesis 2.
  • the outer surface of the first medullary needle 11 and/or the second medullary needle 12 and/or the second medullary needle prosthesis 2 is formed with a three-dimensional porous structure layer 5.
  • the toe joint prosthesis 100 of the present invention may be a toe joint prosthesis or a metacarpophalangeal joint prosthesis.
  • the structure and use method of the toe joint prosthesis 100 of the present invention will be specifically described below by taking the toe joint prosthesis as an example.
  • the toe joint prosthesis 100 is a toe joint prosthesis
  • the first medullary needle prosthesis 1 is used to connect with the metatarsal bone 3
  • the second medullary needle prosthesis 2 is used to connect to the phalanx 4
  • a medullary needle 11 is located inside the medullary cavity of the metatarsal bone 3
  • a second medullary needle 12 is located outside the medullary cavity of the metatarsal bone 3 and abuts the end surface of the metatarsal bone 4.
  • the first medullary needle prosthesis 1 is used to connect with the metacarpal bone
  • the second medullary needle prosthesis 2 is used to connect with the phalanx
  • the first medullary needle 11 Located inside the medullary cavity of the metacarpal bone, the second medullary needle 12 is located outside the medullary cavity of the metacarpal bone and abuts the end surface of the metacarpal bone.
  • the first medullary needle prosthesis 1 is configured to include the first medullary needle 11 and the second medullary needle 12 in two parts, so that the first medullary needle 11 can extend into the medullary cavity 31 of the metatarsal bone 3 so that the medullary cavity can follow
  • the bone tissue within 31 is rapidly fused, and the second medullary needle 12 located outside the metatarsal bone 3 can effectively compensate for the bone defect of the metatarsal bone 3, that is, the length of the second medullary needle 12 to compensate for the length of the bone of the metatarsal bone 3.
  • the second medullary needle 12 is in contact with the end surface of the metatarsal bone 3, which can effectively ensure the stability of the fixation of the first medullary needle prosthesis 1 and the metatarsal bone 3; by connecting one end of the second medullary needle prosthesis 2 to the phalanx 4, the other end Articulated with the first medullary needle prosthesis 1, the second medullary needle prosthesis 2 and the metatarsal bone 3 are connected, and at the same time, the phalange 4 is slid relative to the metatarsal bone 3 to realize the movement function of the toe joint 100.
  • the first medullary needle prosthesis 1 and/or the second The outer surface of the medullary needle prosthesis 2 is formed into a porous structure, so that the first medullary needle 11 has a larger contact area with the inner wall of the medullary cavity 31, that is, the outer surface of the first medullary needle 11 obtains a better bone length
  • the bone tissue in the medullary cavity 31 can quickly grow into the porous structure, thereby helping to stabilize the toe joint prosthesis 100 in the metatarsal bone 3;
  • the porous structure formed on the outer surface of the second medullary needle 12 makes the first The outer surface of the second medullary needle 12 obtains better bone crawling ability, and the bone tissue in the medullary cavity 31 can quickly grow into its porous structure along the outer surface of the second medullary needle 12, thereby making
  • the first medullary needle prosthesis 1 and the second medullary needle prosthesis 2 can be more adapted to the patient's metatarsal bone 3 and phalanx 4
  • the inner diameter and bending curvature of the medullary cavity of the medullary cavity further strengthen the stability of the cooperation between the first medullary needle prosthesis 1 and the metatarsal bone 3, and the second medullary needle prosthesis 2 and the phalanx 4, and the customized production of the first
  • the one-medullary prosthesis 1 and the second-medullary prosthesis 2 also help to restore the length of the toe joint, thereby ensuring that the length of the affected toe joint of the patient is the same as that of the healthy toe joint.
  • the three-dimensional porous structure layer 5 may include a plurality of wire diameters and a plurality of pores formed by staggering and connecting the plurality of wire diameters, each pore is interconnected, and the average diameter of each pore is different, wherein the average diameter of each pore The range is 100 ⁇ m to 400 ⁇ m, and the porosity of the three-dimensional porous structure layer 5 ranges from 50% to 80%.
  • the average diameter of each pore is structurally inconsistent, and the average diameter of the pores of the three-dimensional porous structure layer 5 and the range of porosity are specifically set to make the three-dimensional porous
  • the structure layer 5 is closer to the trabecular structure of the human body, and the three-dimensional porous structure layer 5 with higher porosity and connectivity can induce bone ingrowth, so that the human bone can grow quickly and naturally Into the pores of the three-dimensional porous structure layer 5, thereby improving the ability of osteoblasts to adhere, add value, and differentiate, effectively promote the growth and crawling of the bone tissue in the metatarsal bones 3 and phalanges 4, which is beneficial to the toe joints
  • the prosthesis 100 is quickly fused and fixed with the bone tissue of the human body after the operation, thus effectively improving the recovery effect of the patient after the operation.
  • the density of the pores in the direction from the outside to the inside of the three-dimensional porous structure layer 5 gradually increases, so that during the process of human bone growth, the bone tissue can grow more smoothly from the outside of the three-dimensional porous structure layer 5 quickly It is inserted into the three-dimensional porous structure layer 5 to enhance the fusion and fixation effect of the three-dimensional porous structure layer 5 and human bone tissue.
  • a plurality of convex portions may be formed on the outer peripheral wall of each wire diameter, and the plurality of convex portions are provided to increase the roughness of the outer peripheral wall of the wire diameter to increase its outer periphery
  • the frictional force of the wall makes the bone tissue and wire diameter more secure and stable during the process of bone growth.
  • the convex portion may be a circular convex point or a conical convex point. It is worth noting that the shape of the convex part is not limited to the above-mentioned shape, as long as the convex part can effectively increase the outer surface area of the wire diameter to achieve the purpose of increasing the friction force of the outer peripheral wall, which will not be repeated here . Further, the width of the maximum profile shape of the cross section of the convex portion is 5-50 ⁇ m, and the maximum height is 10-50 ⁇ m.
  • the convex portions may be evenly distributed along the outer surface of the wire diameter, or may be distributed discretely. It is also preferable that the number of protrusions on the wire diameter in the region with a large porosity of the three-dimensional porous structure layer 5 can be greater than the number of protrusions on the wire diameter in the region with a small porosity of the three-dimensional porous structure layer 5 Count to make the bones grow stronger. It is also preferable that the density of the convex portions on the wire diameter on the outer edge of the self-dimensional porous structure layer 5 is greater than the density of the convex portions on the wire diameter inside the self-dimensional porous structure layer 5.
  • the outer surfaces of the first and second medullary needles 11 and 12 are each formed with a three-dimensional porous structure layer 5.
  • the thickness of the three-dimensional porous structure layer 5 formed on the outer surfaces of the first and second medullary needles 11 and 12 may be the same.
  • the thickness of the three-dimensional porous structure layer 5 ranges from 1 mm to 2 mm, more preferably 1.5 mm.
  • the thickness of the three-dimensional porous structure layer 5 formed on the outer surfaces of the first medullary needle 11 and the second medullary needle 12 may also be different, and the thickness of the first medullary needle prosthesis 1 may be specifically determined according to the patients to whom the first medullary needle prosthesis 1 is applied. Design, for example, when the bone ingrowth ability of the patient is poor, in order to ensure the strength of the first prosthetic needle 1, the thickness of the three-dimensional porous structure layer 5 on the outer surface of the first prosthetic needle 11 can be set to be higher than that of the second The thickness of the three-dimensional porous structure layer 5 on the outer surface of the medullary needle 12 is thicker.
  • the thickness of the three-dimensional porous structure layer 5 on the outer surface of the second medullary needle 12 can be set to The thickness of the three-dimensional porous structure layer 5 on the outer surface of the first pulp 11 is thicker.
  • the average diameter of the pores formed in the three-dimensional porous structure layer 5 on the outer surface of the first medullary needle 11 may be greater than the average of the pores formed in the three-dimensional porous structure layer 5 on the outer surface of the second medullary needle 12. diameter.
  • the average diameter of each pore in the porous three-dimensional structure layer 5 formed on the outer surface of the first medullary needle 11 is preferably in the range of 200 ⁇ m to 400 ⁇ m, and the porosity in this area can be controlled at 50% to 60% It is further preferably 300 ⁇ m to 400 ⁇ m, and the porosity can be controlled between 50% and 55%;
  • the average diameter of the pores formed in the porous three-dimensional structure layer 5 on the outer surface of the second medullary needle 12 is preferably 100 ⁇ m Up to 200 ⁇ m, the porosity can be controlled between 70% and 80%, further preferably 100 ⁇ m to 150 ⁇ m, and the porosity can be controlled between 75% and 80%.
  • the diameter of the porous three-dimensional structure layer 5 formed on the outer surface of the first medullary needle 11 is 200 ⁇ m to 400 ⁇ m, bone ingrowth can be better promoted, so that the initial replacement of the toe joint prosthesis 100 can be obtained more Stable fixation effect; while the porous solid structure layer 5 formed on the outer surface of the second medullary needle 12 has a diameter in the range of 100 ⁇ m to 200 ⁇ m, the bone crawling grows fastest, which can accelerate the replacement of the toe joint prosthesis 100 The growth of bone tissue in the middle and later stages promotes faster recovery of patients.
  • a connection 13 between the second medullary needle 12 and the first medullary needle 11 may be formed with a platform 13 for abutting the end surface of the metatarsal bone 3.
  • the platform 13 is used to carry the force from the metatarsal bone 3, which is The platform manner achieves a better mechanical bearing function of the second medullary needle 12, thereby helping to improve the overall mechanical bearing capacity of the first medullary needle prosthesis 1.
  • the second medullary needle 12 may be configured as a column having a circular cross section, so that the toe joint prosthesis 100 is more stable when used, and the support effect on the metatarsal bone 3 is more stable.
  • a three-dimensional porous structure layer 5 is formed on the outer surfaces of the first medullary needle 11, the second medullary needle 12, and the second medullary needle prosthesis 2, formed on the second medullary needle prosthesis 2
  • the thickness of the three-dimensional porous structure layer 5 on the outer surface of the outer surface may be the same as or different from the thickness of the three-dimensional porous structure layer 5 on the outer surface of the first and second medullary needles 11 and 12, the specific thickness may vary according to Different patients can be specifically designed for the two-medullary needle prosthesis 2, and the structure of this part will be described in detail below.
  • the first prosthetic needle prosthesis 1 may further include a hinge joint 14 fixedly connected to the second prosthetic needle 12, and an end of the hinge joint 14 facing the second prosthetic prosthesis 2 is configured as a spherical shape
  • the second medullary prosthesis 2 includes a spherical recess 21.
  • the end surface of the spherical recess 21 facing the hinge joint 14 is configured with a concave spherical surface 211 that cooperates with the spherical surface 141.
  • the hinge joint 14 and the second prosthesis 2 form a spherical articulated connection.
  • the two-medullary needle prosthesis 2 swings relative to the center line of the articulated joint 14 and can also rotate the second-medullary needle prosthesis 2 relative to the articulated joint 14 to improve the flexibility of the relative movement of the metatarsal bones 3 and the phalanges 4.
  • the fixed connection between the second medullary needle 12 and the hinge joint 14 may be a threaded connection, so that the second medullary needle 12 and the hinge joint 14 are stable and easy to install or remove. For example, as shown in FIGS.
  • the end surface of the second medullary needle 12 in contact with the hinge joint 14 may be provided with a stud 121, and the end surface of the articulated joint 14 in contact with the second medullary needle 12 may be formed with a stud 121Threaded screw hole 142.
  • the second medullary needle prosthesis 2 may further include a needle-shaped portion 22 connected to the spherical recess 21 for implantation in the medullary cavity 41 of the phalanx 4.
  • the spherical recess 21 further includes a An outwardly protruding arc surface 23 between the concave spherical surface and the outer peripheral wall of the needle-shaped portion 22 is in contact with the end surface of the phalanx 4, and the three-dimensional porous structure layer 5 is formed on the arc surface 23.
  • the needle-shaped portion 22 can extend into the medullary cavity 41 of the phalangeal bone 4 for subsequent rapid fusion with the bone tissue in the medullary cavity 41, and the curved surface 23 located outside the phalanx bone 4 can The contact area between the surface and the end surface of the phalanx 4 is effectively increased, so that the stability of the fixation of the second prosthesis 2 and the phalanx 4 can be effectively ensured.
  • the height of the second medullary prosthesis 2 and the phalanx 4 can be adjusted by adjusting the outwardly protruding arc of the arc-shaped surface 23 to effectively compensate for the length of the bone of the phalanx 4 defect.
  • the outer surface of the second prosthetic needle prosthesis 2 is formed into a porous structure, so that the porous structure also allows the curved surface 23 to obtain better bone ingrowth The ability to crawl with bones, so that the bone tissue in the medullary cavity 41 can quickly grow into its porous structure along the curved surface 23, thereby making the fixation of the second medullary prosthesis 2 and the phalanx 4 more stable.
  • the curved surface 23 of the spherical recess may include a first surface 231 extending into the medullary cavity 41 of the phalanx 4 and a second surface 232 located outside the medullary cavity 41 of the phalanx 4
  • the average diameter of the pores of the three-dimensional porous structure layer 5 formed on the first surface 231 is greater than the average diameter of the pores in the three-dimensional porous structure layer 5 formed on the second surface 232.
  • the average diameter of the pores of the three-dimensional porous structure layer 5 formed on the first surface 231 is in the range of 200 ⁇ m to 400 ⁇ m.
  • the porosity of this region can be controlled between 50% and 60%, and is more preferably 300 ⁇ m to 400 ⁇ m, the porosity can be controlled between 50% and 55%; the average diameter of the pores in the three-dimensional porous structure layer 5 formed on the second surface 232 ranges from 100 ⁇ m to 200 ⁇ m, and the porosity can be controlled at this time Between 70% and 80%, further preferably 100 ⁇ m to 150 ⁇ m, the porosity can be controlled between 75% and 80%.
  • the diameter of the porous three-dimensional structure layer 5 formed on the first surface 231 is in the range of 200 ⁇ m to 400 ⁇ m, bone ingrowth can be better promoted, so that the initial replacement of the toe joint prosthesis 100 can be more stable
  • the diameter of the porous three-dimensional structure layer 5 formed on the second surface 232 is 100 ⁇ m to 200 ⁇ m, the bone crawling grows the fastest, which can accelerate the bone tissue of the mid-term and late phase of the replacement of the toe joint prosthesis 100 Growth, which in turn promotes faster recovery of patients.
  • the thickness of the three-dimensional porous structure layer 5 formed on the first surface 231 and the second surface 232 may also be different, and specific designs can be made according to the different patients to which the second medullary prosthesis 2 is applied, for example, when the patient's bone length
  • the thickness of the three-dimensional porous structure layer 5 of the first surface 231 may be set to be greater than the thickness of the three-dimensional porous structure layer 5 of the second surface 232 thick.
  • the thickness of the three-dimensional porous structure layer 5 of the second surface 232 can be set to be higher than that of the first surface 231 The thickness of the three-dimensional porous structure layer 5 is thicker.
  • the arc-shaped surface 23 may be connected between the concave spherical surface 211 and the outer peripheral wall of the middle of the needle 22.
  • the three-dimensional porous structure layer 5 formed on the curved surface 23 can save the material of the three-dimensional porous structure layer 5 under the premise of satisfying the better bone ingrowth and faster bone crawling of the phalanges 4 and avoiding Cause waste.
  • the arc-shaped surface 23 may also be connected between the concave spherical surface 211 and the outer peripheral wall of the middle and upper portion of the needle 22, or between the concave spherical surface 211 and the outer peripheral wall of the middle and lower portion of the needle 22, which
  • the specific settings can be set according to the needs of different patients to meet the individual differences of patients.
  • the outer surface of the needle 22 may be configured as a rough surface. That is, the outer surface of the needle-shaped portion 22 outside the arc-shaped surface 23 may be configured as a rough surface.
  • the needle-shaped portion 22 can be fixed by bone cement in the medullary cavity 41 of the phalanx 4. With this arrangement, the outer surface of the needle-shaped portion 22 has a larger contact area, which helps bone cement to more firmly fix the needle-shaped portion 22 and the medullary cavity 41 of the phalanx 4 together.
  • the first medullary needle 11, the second medullary needle 12, and the porous three-dimensional structure layer 5 may be integrally formed, and/or the second medullary needle prosthesis 2 and the porous three-dimensional structure layer 5 may One piece.
  • the three-dimensional porous structure layer 5 can be made of metal powder, which can be titanium alloy, pure titanium or tantalum metal.
  • the three-dimensional porous structure layer 5 is made of titanium alloy material, preferably Ti6Al4V.
  • the first medullary needle 11, the second medullary needle 12, and the second medullary needle prosthesis 2 can also be made of titanium alloy material.
  • the integrated molding method not only facilitates the processing of the first prosthesis 1 and the second prosthesis 2, but also reduces the components of the first prosthesis 1 and the second prosthesis 2.
  • the interaction force between them makes the overall structure of the first prosthesis 1 and the second prosthesis 2 more stable and better in mechanical strength.
  • first suture holes 122 formed on the second medullary needle 12 there may be multiple first suture holes 122 formed on the second medullary needle 12, and there may also be multiple second suture holes 143 formed on the hinge joint 14. Further preferably, as shown in FIG. 3, the number of first suture holes 122 formed on the second medullary needle 12 may be equal to the number of second suture holes 143 formed on the hinge joint 14, and each A suture hole 122 and each second suture hole 143 are close to the outside of the toe joint 100.
  • each first suture hole 122 and each second suture hole 143 are arranged on the same vertical line, so that the joint capsule sutured through the first suture hole 122 and the second suture hole 143 and the human body
  • the joint capsule is more similar in order to further improve its motor function after implanting the toe joint prosthesis 100.
  • the diameter range of the first suture hole 122 and the second suture hole 143 may be 2.5 mm to 4 mm; further, the first suture hole 122 and the second suture hole 143 are specifically along the corresponding holes
  • the axially curved through hole, the axial length of the through hole with curved curvature may range from 2.5 mm to 40 mm.
  • the specific length value can be determined according to the diameter of the suture looper used in the suturing process and the curved curvature of the suture looper, so as to facilitate surgical operation and better suture of soft tissue.
  • the above technical solution is also applicable when the toe joint prosthesis 100 is applied to the replacement of the metacarpophalangeal joint of a patient, that is, when the toe joint prosthesis 100 is a metacarpophalangeal joint prosthesis, only the toe
  • the first medullary needle prosthesis 1 of the joint prosthesis 100 is used to connect with the metacarpal bone
  • the second medullary needle prosthesis 2 is used to connect with the phalanx to replace the metatarsal and phalanx mentioned in the above technical solution, which will not be repeated here. .
  • the manufacturing method of the toe joint prosthesis according to the present invention includes the following steps:
  • a three-dimensional porous structure layer is formed on the outer surface of the first medullary needle and/or the second medullary needle and/or the second medullary needle prosthesis;
  • the first medullary needle is arranged in the bone marrow cavity
  • the second medullary needle is arranged outside the bone marrow cavity
  • the first medullary needle and the second medullary needle are connected to form a first medullary needle prosthesis
  • the toe joint prosthesis is a toe joint prosthesis, wherein the first medullary needle prosthesis is used to connect with the metatarsal bone, and the second medullary needle prosthesis is used to connect to the phalanx, and the first marrow
  • the needle is located inside the medullary cavity of the metatarsal bone, and the second medullary needle is located outside the medullary cavity of the metatarsal bone and abuts the end surface of the metatarsal bone.
  • the toe joint prosthesis is a metacarpal toe joint prosthesis, wherein the first medullary needle prosthesis is used to connect with the metacarpal bone, and the second medullary needle prosthesis is used to connect with the phalanx, and the first The medullary needle is located inside the medullary cavity of the metacarpal bone, and the second medullary needle is located outside the medullary cavity of the metacarpal bone and abuts the end surface of the metacarpal bone.
  • the specific step of forming a three-dimensional porous structure layer on the outer surface of the first medullary needle and/or the second medullary needle and/or the second medullary needle prosthesis includes:
  • micro-CT to three-dimensionally scan the first and/or second medullary needle prosthesis, and use MIMICS to reconstruct the scanned data to obtain a three-dimensional schematic model
  • the three-dimensional schematic model is divided into regions, and the divided regions are adapted to different growth requirements of the same organization, and the diameter of the pores in each region is further adjusted so that different regions have different porosities;
  • 3D printing equipment is used to generate a solid model of the first and/or second medullary needle prosthesis, and the surface of the wire diameter in the generated solid model is adjusted by adjusting the focus parameter of the 3D printing equipment Multiple protrusions are formed, where the value of the focus offset parameter ranges from 5.8mA to 6.2mA.
  • the average diameter of each pore in the three-dimensional porous structure layer formed on the outer surface of the first medullary needle is larger than that in each of the three-dimensional porous structure layer formed on the outer surface of the second medullary needle The average diameter of the pores.
  • the first prosthetic needle prosthesis further includes a hinge joint fixedly connected to the second prosthetic needle, an end of the hinge joint facing the second prosthetic prosthesis is configured as a spherical surface, and the first The two-medullary prosthesis includes a spherical concave portion, and an end surface of the spherical concave portion facing the hinge joint is configured as a concave spherical surface that cooperates with the spherical surface.
  • the second medullary needle prosthesis further includes a needle-shaped portion connected to the spherical concave portion, and the spherical concave portion further includes a direction connected between the concave spherical surface and the outer peripheral wall of the needle-shaped portion An outwardly protruding arc surface, the three-dimensional porous structure layer is formed on the arc surface.
  • the curved surface of the spherical recess includes a first surface extending into the medullary cavity and a second surface located outside the medullary cavity, wherein each of the three-dimensional porous structure layers formed on the first surface The average diameter of the pores is larger than the average diameter of each pore in the three-dimensional porous structure layer formed on the second surface.
  • the average diameter of each pore of the three-dimensional porous structure layer formed on the first surface ranges from 100 ⁇ m to 200 ⁇ m
  • the average diameter of each pore of the three-dimensional porous structure layer formed on the second surface is The range is 200 ⁇ m to 400 ⁇ m.
  • a side wall of the second medullary needle is further formed with a first suture hole penetrating the second medullary needle, and an end of the hinge joint close to the second medullary needle is formed therethrough The second suture hole of the hinge joint.
  • the outer surface of the needle-shaped portion is configured as a rough surface.

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Abstract

一种趾关节假体（100）及其制作方法，该趾关节假体（100）包括：第一髓针假体（1）和与第一髓针假体（1）铰接的第二髓针假体（2）。所述第一髓针假体（1）包括用于设置在骨髓腔内的第一髓针（11）和与第一髓针（11）相连且位于骨髓腔外部的第二髓针（12），第二髓针（12）与第二髓针假体（2）铰接，其中第一髓针（11）和/或第二髓针（12）和/或第二髓针假体（2）的外表面形成有立体多孔结构层（5），该趾关节假体的外表面能够获得更好的骨长入能力和骨爬行能力，从而使得该趾关节假体的固定更为稳定。

Description

趾关节假体及其制作方法
相关申请的交叉引用
本申请要求北京市春立正达医疗器械股份有限公司于2018年12月4日提交的、发明名称为“趾关节假体”、申请号为“201811472414.9”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本发明涉及医用假体技术领域，尤其涉及一种趾关节假体及其制作方法。
背景技术
趾关节假体是应用于趾关节置换术中的用来代替人体病患趾关节部位的外科植入物。当人体的趾关节因遭遇肿瘤或者粉碎性骨折等情况需要修复时，往往容易造成趾关节的严重骨缺损，严重的骨缺损不仅使趾关节的截骨的位置力的承载能力变差，还容易导致趾关节处的肌肉的附着点缺损或关节囊损坏等问题，此时需要选择适合的趾关节假体来置换病患的趾关节。
现有的趾关节假体主要由第一髓针假体和第二髓针假体两部分组成，第一髓针假体和第二髓针假体之间铰接以实现趾关节假体的活动功能。然而，现有的趾关节假体一方面其第一髓针假体和第二髓针假体不能有效地分别与患处的截骨段固定；另一方面也不能更有效地重建趾关节假体附近的肌肉的附着点和关节囊，这就无法保证趾关节假体植入后的稳定性，从而不利于患者术后的康复，甚至容易造成对患者的二次伤害。
针对现有技术的不足，本领域的技术人员急需寻求一种植入后更为稳定的趾关节假体，以弥补现有技术的不足。
发明内容
为了使植入后的趾关节假体更为稳定，本发明提出了一种趾关节假体及其制作方法。
根据本发明的趾关节假体，包括：第一髓针假体和与第一髓针假体铰接的第二髓针假体，第一髓针假体包括用于设置在骨髓腔内的第一髓针和与第一髓针相连且位于骨髓腔外部的第二髓针，第二髓针与第二髓针假体铰接，其中，第一髓针和/或第二髓针和/或第二髓针假体的外表面形成有立体多孔结构层。
进一步地，趾关节假体为脚趾关节假体，其中第一髓针假体用于与跖骨相 连，第二髓针假体用于与趾骨相连，第一髓针位于跖骨的髓腔内部，第二髓针位于跖骨的髓腔外部且与跖骨的端面抵接。
进一步地，趾关节假体为掌趾关节假体，其中第一髓针假体用于与掌骨相连，第二髓针假体用于与指骨相连，第一髓针位于掌骨的髓腔内部，第二髓针位于掌骨的髓腔外部且与掌骨的端面抵接。
进一步地，立体多孔结构层包括多条丝径和由多条丝径相互交错连接形成的多个孔隙，各孔隙相互连通，且各孔隙的平均直径不同，其中，各孔隙的平均直径范围为100μm至400μm，且立体多孔结构层的孔隙率的范围为50％至80％。
进一步地，形成在第一髓针的外表面的立体多孔结构层中的各孔隙的平均直径大于形成在第二髓针的外表面的立体多孔结构层中的各孔隙的平均直径。
进一步地，第一髓针假体还包括与第二髓针固定连接的铰接头，铰接头的朝向第二髓针假体的一端构造为球形面，第二髓针假体包括球形凹部，球形凹部的朝向铰接头的端面构造为与球形面配合的凹形球面。
进一步地，第二髓针假体还包括与球形凹部相连的针状部，球形凹部还包括连接在凹形球面与针状部的外周壁之间的向外突出的弧形表面，立体多孔结构层形成在弧形表面上。
进一步地，球形凹部的弧形表面包括用于延伸进入髓腔内的第一表面和位于髓腔外的第二表面，其中，形成在第一表面上的立体多孔结构层的各孔隙的平均直径大于形成在第二表面上的立体多孔结构层中的各孔隙的平均直径。
进一步地，形成在第一表面上的立体多孔结构层的各孔隙的平均直径的范围为100μm至200μm，形成在第二表面上的立体多孔结构层中的各孔隙的平均直径的范围为200μm至400μm。
进一步地，第二髓针的侧壁上还形成有贯穿第二髓针的第一缝线孔，铰接头的靠近第二髓针的一端上形成有贯穿铰接头的第二缝线孔。
进一步地，针状部的外表面构造为粗糙面。
进一步地，第一髓针、第二髓针以及多孔立体结构层一体成型，和/或，第二髓针假体与多孔立体结构层一体成型。
根据本发明的趾关节假体的制作方法，包括以下步骤：
第一、在第一髓针和/或第二髓针和/或第二髓针假体的外表面形成立体多孔结构层；
第二、将第一髓针设置在骨髓腔内，将第二髓针设置在骨髓腔外部，将第一髓针和第二髓针相连，构成第一髓针假体；
第三、将第一髓针假体和第二髓针假体铰接，构成趾关节假体。
进一步地，所述趾关节假体为脚趾关节假体，其中，所述第一髓针假体用于与跖骨相连，所述第二髓针假体用于与趾骨相连，所述第一髓针位于所述跖骨的髓腔内部，所述第二髓针位于所述跖骨的髓腔外部且与所述跖骨的端面抵接。
进一步地，所述趾关节假体为掌趾关节假体，其中，所述第一髓针假体用于与掌骨相连，所述第二髓针假体用于与指骨相连，所述第一髓针位于所述掌骨的髓腔内部，所述第二髓针位于所述掌骨的髓腔外部且与所述掌骨的端面抵接。
进一步地，在第一步骤中，在第一髓针和/或第二髓针和/或第二髓针假体的外表面形成立体多孔结构层的具体步骤包括：
采用显微CT对第一髓针和/或第二髓针和/或第二髓针假体进行三维扫描，并采用MIMICS对扫描的数据进行模型重建，以获得三维示意模型；
对三维示意模型进行区域划分，划分的各区域分别适应于同一种组织的不同长入要求，进一步调整各区域的孔隙的直径，以使不同的区域具有不同的孔隙率；
采用3D打印设备来生成第一髓针和/或第二髓针和/或第二髓针假体的实体模型，通过调整3D打印设备的focus offset参数使得生成的实体模型中的丝径的表面形成多个凸起，其中focus offset参数的取值范围为5.8mA至6.2mA。
进一步地，形成在所述第一髓针的外表面的所述立体多孔结构层中的各孔隙的平均直径大于形成在所述第二髓针的外表面的所述立体多孔结构层中的各孔隙的平均直径。
进一步地，所述第一髓针假体还包括与所述第二髓针固定连接的铰接头，所述铰接头的朝向所述第二髓针假体的一端构造为球形面，所述第二髓针假体包括球形凹部，所述球形凹部的朝向所述铰接头的端面构造为与所述球形面配合的凹形球面。
进一步地，所述第二髓针假体还包括与所述球形凹部相连的针状部，所述球形凹部还包括连接在所述凹形球面与所述针状部的外周壁之间的向外突出的 弧形表面，所述立体多孔结构层形成在所述弧形表面上。
进一步地，所述球形凹部的弧形表面包括用于延伸进入髓腔内的第一表面和位于髓腔外的第二表面，其中，形成在所述第一表面上的立体多孔结构层的各孔隙的平均直径大于形成在所述第二表面上的立体多孔结构层中的各孔隙的平均直径。
进一步地，形成在所述第一表面上的立体多孔结构层的各孔隙的平均直径的范围为100μm至200μm，形成在所述第二表面上的立体多孔结构层中的各孔隙的平均直径的范围为200μm至400μm。
进一步地，所述第二髓针的侧壁上还形成有贯穿所述第二髓针的第一缝线孔，所述铰接头的靠近所述第二髓针的一端上形成有贯穿所述铰接头的第二缝线孔。
进一步地，所述针状部的外表面构造为粗糙面。
进一步地，所述第一髓针、所述第二髓针以及所述多孔立体结构层一体成型，和/或，所述第二髓针假体与所述多孔立体结构层一体成型。
与现有技术相比，本发明的趾关节假体具有以下几方面的优势：
1)通过在第一髓针假体和/或第二髓针假体的外表面形成有立体多孔结构层，使得第一髓针假体和/或第二髓针假体的外表面获得了更好的骨长入能力和骨爬行能力，从而使得趾关节假体的固定更为稳定。
2)立体多孔结构层的设置还可以有效降低趾关节假体的重量，并有助于重建软组织和肌肉的附着点，从而可以有效降低患者术后的恢复时间，并大大地改善了患者术后的恢复效果。
3)通过对本发明的趾关节假体的第一髓针假体和第二髓针假体进行定制化生产，不仅能够更适应患者的髓腔的内径和弯曲曲率，从而进一步加强趾关节假体的稳定性，还能够帮助恢复趾关节的长度，从而确保了患者的患处趾关节与健康趾关节的长度保持一致。
4)第一缝线孔与第二缝线孔的设置还有助于修复或重建破损的关节囊，从而利于患者的术后恢复。
附图说明
为了更清楚地说明本发明具体实施方式或现有技术中的技术方案，下面将对具体实施方式或现有技术描述中所需要使用的附图作简单地介绍。在所有附图中，类似的元件或部分一般由类似的附图标记标识。附图中，各元件或部分 并不一定按照实际的比例绘制。
图1为根据本发明的趾关节假体的结构示意图；
图2为图1所示的趾关节假体与跖骨和趾骨的连接示意图；
图3为图1所示的第一髓针假体的结构示意图；
图4为图3所示的铰接头的结构示意图；
图5为图1所示的第二髓针假体的结构示意图。
具体实施方式
下面将结合附图对本发明技术方案的实施例进行详细的描述。以下实施例仅用于更加清楚地说明本发明的技术方案，因此只作为示例，而不能以此来限制本发明的保护范围。
图1示出了根据本发明的趾关节假体100的结构。如图1所示，该趾关节假体100包括：第一髓针假体1和与第一髓针假体1铰接的第二髓针假体2，第一髓针假体1包括用于设置在骨髓腔内的第一髓针11和与第一髓针11相连且位于骨髓腔外部的第二髓针12，第二髓针12与第二髓针假体2铰接。其中，第一髓针11和/或第二髓针12和/或第二髓针假体2的外表面形成有立体多孔结构层5。值得注意的是，本发明的趾关节假体100可以为脚趾关节假体或掌指关节假体。下面将以脚趾关节假体为例对本发明的趾关节假体100的结构和使用方法进行具体说明。
结合图1和图2所示，该趾关节假体100为脚趾关节假体，第一髓针假体1用于与跖骨3相连，第二髓针假体2用于与趾骨4相连，第一髓针11位于跖骨3的髓腔内部，第二髓针12位于跖骨3的髓腔外部且与跖骨4的端面抵接。
需要说明的是，当趾关节假体100为掌趾关节假体时，第一髓针假体1用于与掌骨相连，第二髓针假体2用于与指骨相连，第一髓针11位于掌骨的髓腔内部，第二髓针12位于掌骨的髓腔外部且与掌骨的端面抵接。
如图2所示，本发明的脚趾关节假体在应用于脚趾关节的置换时，需要对患者的跖骨3和趾骨4处做截骨处理，截骨处理后的跖骨3和趾骨4存在大量的骨缺损。本发明通过将第一髓针假体1设置成包括第一髓针11和第二髓针12两部分，使得第一髓针11可延伸进入跖骨3的髓腔31内以便其后续与髓腔31内的骨组织的快速融合，而位于跖骨3外部的第二髓针12可以有效弥补跖骨3的骨缺损，即通过第二髓针12的长度来弥补跖骨3缺损的骨的长度。同时第二髓针12与跖骨3的端面相抵接，可有效确保第一髓针假体1与跖骨3固定 的稳定性；通过将第二髓针假体2的一端与趾骨4相连，另一端与第一髓针假体1铰接，实现了第二髓针假体2与跖骨3的连接的同时还实现了趾骨4相对于跖骨3的滑动，以实现趾关节100的活动功能。
而通过在第一髓针11和/或第二髓针12和/或第二髓针假体2的外表面形成有立体多孔结构层5，使得第一髓针假体1和/或第二髓针假体2的外表面形成为多孔结构，这样，第一髓针11具有了与髓腔31的内壁更大的接触面积，即第一髓针11的外表面获得了更好的骨长入能力，髓腔31内的骨组织可快速长入多孔结构中，从而有助于趾关节假体100在跖骨3内稳定的固定；在第二髓针12的外表面形成的多孔结构使得第二髓针12的外表面获得了更好的骨爬行能力，髓腔31内的骨组织可沿第二髓针12的外表面快速长入其多孔结构中，从而使得第一髓针假体1与跖骨3的固定更为稳定；而在第二髓针假体2的外表面形成的多孔结构，同样使得第二髓针假体2与趾骨4具有了更大的接触面积，髓腔41内的骨组织可快速长入多孔结构中，从而使第二髓针假体2的外表面获得了更好的骨长入和骨爬行的能力，进而使得第二髓针假体2与趾骨4的固定更为稳定。
另外，立体多孔结构层5的设置可以有效降低趾关节假体100的重量，并且还有助于重建软组织和肌肉的附着点，从而可以有效降低患者术后的恢复时间，并大大地改善了患者术后的恢复效果。
此外，通过对第一髓针假体1和第二髓针假体2进行定制化生产，可使第一髓针假体1和第二髓针假体2更适应患者的跖骨3和趾骨4的髓腔的内径和弯曲曲率，从而进一步加强了第一髓针假体1与跖骨3之间、以及第二髓针假体2与趾骨4之间配合的稳定性，而且定制化生产的第一髓针假体1和第二髓针假体2还有助于恢复脚趾关节的长度，从而确保了患者的患处脚趾关节与健康脚趾关节的长度保持一致。
根据本发明，立体多孔结构层5可包括多条丝径和由多条丝径相互交错连接形成的多个孔隙，各孔隙相互连通，且各孔隙的平均直径不同，其中，各孔隙的平均直径范围为100μm至400μm，且立体多孔结构层5的孔隙率的范围为50％至80％。通过将由丝径相互交错连接形成的各孔隙相互连通，且将各孔隙的平均直径大小构造地不一致，并对立体多孔结构层5的孔隙的平均直径和孔隙率的范围进行具体设置，使得立体多孔结构层5的结构与人体的骨小梁结构更为接近，具有较高的孔隙率和联通性的立体多孔结构层5能够很好的诱导骨长入，这样人体的骨质可快速自然地长入立体多孔结构层5的孔隙中，从而提高了成骨细胞的粘附、增值、分化的能力，有效地促进了跖骨3和趾骨4内 的骨组织的长入和爬行，进而有利于趾关节假体100在术后与人体的骨组织快速融合和固定，因此有效地提高了患者术后的恢复效果。
优选地，自立体多孔结构层5的外部至内部的方向上的孔隙的密度逐渐增大，从而使人体骨长入的过程中，骨组织能够更顺利地由立体多孔结构层5的外部快速长入立体多孔结构层5的内部，以提升立体多孔结构层5与人体骨组织的融合与固定效果。
还优选地，各丝径的外周壁上可形成有多个凸部(图中未示出)，该多个凸部的设置用于增加丝径的外周壁的粗糙度，以增大其外周壁的摩擦力，这样，在骨长入的过程中，骨组织与丝径的固定更为牢固和稳定。优选地，该凸部可以是圆形的凸点，也可以是锥状的凸点。值得注意的是，该凸部的形状并不仅仅局限于上述形状，只要该凸部能够有效地增加丝径的外表面积以实现增大其外周壁的摩擦力的目的即可，这里不再赘述。进一步地，该凸部的横截面的最大轮廓形状的宽度范围为5-50μm，最大高度范围为10-50μm。
还优选地，凸部可沿丝径的外表面均匀分布，也可以离散式分布。还优选地，在立体多孔结构层5的孔隙率较大的区域的丝径上的凸部的个数可大于立体多孔结构层5的孔隙率较小的区域的丝径上的凸部的个数，以使骨长入更为牢固。还优选地，自立体多孔结构层5的外边缘上的丝径上的凸部的密度大于自立体多孔结构层5的内部的丝径上的凸部的密度。
在一个优选的实施方式中，第一髓针11和第二髓针12的外表面均形成有立体多孔结构层5。优选地，形成在第一髓针11和第二髓针12的外表面的立体多孔结构层5的厚度可以相同。优选地，立体多孔结构层5的厚度范围为1mm至2mm，更优选为1.5mm。通过该设置，一方面使得第一髓针假体1具有更利于骨长入和骨爬行的外表面，另一方面还使得第一髓针假体1具有更好的承载、传导及分散应力载荷的能力，从而使趾关节假体100获得更稳定的使用效果。
当然，形成在第一髓针11和第二髓针12的外表面的立体多孔结构层5的厚度也可以不同，根据第一髓针假体1所适用的患者的不同可对其进行具体的设计，例如当患者骨长入能力较差时，为了保证第一髓针假体1的强度，可将第一髓针11的外表面的立体多孔结构层5的厚度设置的相比于第二髓针12的外表面的立体多孔结构层5的厚度更厚。而当患者自身的骨爬行能力较差时，为了保证第一髓针假体1的固定的稳定性，可将第二髓针12的外表面的立体多孔结构层5的厚度设置的相比于第一髓针11的外表面的立体多孔结构层5的厚度更厚。
优选地，形成在第一髓针11的外表面的立体多孔结构层5中的各孔隙的平均直径可大于形成在第二髓针12的外表面的立体多孔结构层5中的各孔隙的平均直径。进一步地，形成在第一髓针11的外表面的多孔立体结构层5中的各孔隙的平均直径的范围优选为200μm至400μm，此时该区域的孔隙率可控制在50％至60％之间，进一步优选为300μm至400μm，孔隙率可控制在50％至55％之间；形成在第二髓针12的外表面的多孔立体结构层5中的各孔隙的平均直径的范围优选为100μm至200μm，此时孔隙率可控制在70％至80％之间，进一步优选为100μm至150μm，孔隙率可控制在75％至80％之间。
通过上述设置，形成在第一髓针11的外表面的多孔立体结构层5的直径在200μm至400μm时，能够更好的促进骨长入，从而使趾关节假体100置换的初期能够获得更稳定的固定效果；而形成在第二髓针12的外表面的多孔立体结构层5的直径的范围为100μm至200μm时，骨爬行生长的速度最快，从而能够加快趾关节假体100置换的中期和后期的骨组织的生长，进而促进患者更快的康复。
如图3所示，第二髓针12与第一髓针11的连接处可形成有用于与跖骨3的端面抵接的平台13，该平台13用于承载来自跖骨3的作用力，其以平台的方式实现了第二髓针12更好的力学承载功能，从而有助于提高第一髓针假体1的整体的力学承载能力。优选地，第二髓针12可构造成横截面为圆形的柱状，从而使趾关节假体100在使用时更稳定，对跖骨3的支撑效果更稳定。
在另一个优选的实施方式中，第一髓针11、第二髓针12以及第二髓针假体2的外表面上均形成有立体多孔结构层5，形成在第二髓针假体2的外表面的立体多孔结构层5的厚度可以与上述的第一髓针11和第二髓针12的外表面的立体多孔结构层5的厚度相同，也可不同，该具体的厚度可根据第二髓针假体2所适用的患者的不同可进行具体的设计，下文会对该部分结构进行具体的说明。
根据本发明，如图3所示，第一髓针假体1还可包括与第二髓针12固定连接的铰接头14，铰接头14的朝向第二髓针假体2的一端构造为球形面141；如图5所示，第二髓针假体2包括球形凹部21，球形凹部21的朝向铰接头14的端面构造有与球形面141配合的凹形球面211。通过铰接头14的球形面141与第二髓针假体2的凹形球面211的配合，使铰接头14与第二髓针假体2形成球面铰接的连接方式，该连接方式不仅能够使第二髓针假体2相对于铰接头14的中心线摆动，还能够使第二髓针假体2相对于铰接头14转动，以提高跖骨3和趾骨4的相对的运动的灵活性。优选地，第二髓针12与铰接头14的固定连 接方式可以为螺纹连接，以使第二髓针12与铰接头14的固定稳定且易于安装或拆卸。例如，如图3和图4所示，第二髓针12的与铰接头14接触的端面可设置有螺柱121，铰接头14的与第二髓针12接触的端面可形成有与螺柱121螺纹连接的螺纹孔142。
根据本发明，如图5所示，第二髓针假体2还可包括与球形凹部21相连的用于植入趾骨4的髓腔41内的针状部22，球形凹部21还包括连接在凹形球面与针状部22的外周壁之间的向外突出的弧形表面23，弧形表面23与趾骨4的端面相抵接，立体多孔结构层5形成在弧形表面23上。通过该设置，结合图2所示，针状部22可延伸进入趾骨4的髓腔41内以便其后续与髓腔41内的骨组织的快速融合，而位于趾骨4外部的弧形表面23可有效地增加其表面与趾骨4的端面的接触面积，从而可有效地确保第二髓针假体2与趾骨4固定的稳定性。此外，通过调整弧形表面23的向外突出的弧度还可调整第二髓针假体2与趾骨4配合后的高度，以有效弥补趾骨4缺损的骨的长度。而通过在弧形表面23上进一步形成立体多孔结构层5，使得第二髓针假体2的外表面形成为多孔结构，这样，多孔结构也使得弧形表面23获得了更好的骨长入和骨爬行的能力，从而使髓腔41内的骨组织可沿弧形表面23快速长入其多孔结构中，进而使得第二髓针假体2与趾骨4的固定更为稳定。
在如图2所示的优选的实施例中，球形凹部的弧形表面23可包括延伸进入趾骨4的髓腔41内的第一表面231和位于趾骨4的髓腔41外的第二表面232，其中，形成在第一表面231上的立体多孔结构层5的各孔隙的平均直径大于形成在第二表面232上的立体多孔结构层5中的各孔隙的平均直径。进一步地，形成在第一表面231上的立体多孔结构层5的各孔隙的平均直径的范围为200μm至400μm，此时该区域的孔隙率可控制在50％至60％之间，进一步优选为300μm至400μm，孔隙率可控制在50％至55％之间；形成在第二表面232上的立体多孔结构层5中的各孔隙的平均直径的范围为100μm至200μm，此时孔隙率可控制在70％至80％之间，进一步优选为100μm至150μm，孔隙率可控制在75％至80％之间。
通过上述设置，形成在第一表面231上的多孔立体结构层5的直径的范围为200μm至400μm时，能够更好的促进骨长入，从而使趾关节假体100置换的初期能够获得更稳定的固定效果；而形成在第二表面232上的多孔立体结构层5的直径在100μm至200μm时，骨爬行生长的速度最快，从而能够加快趾关节假体100置换的中期和后期的骨组织的生长，进而促进患者更快的康复。
在一个优选的实施方式中，形成在第一表面231和第二表面232的立体多 孔结构层5的厚度可以相同。优选地，立体多孔结构层5的厚度范围为1mm至2mm，更优选为1.5mm。通过该设置，一方面使得第二髓针假体2具有更利于骨长入和骨爬行的外表面，另一方面还使得第二髓针假体2具有更好的承载、传导及分散应力载荷的能力，从而使趾关节假体100获得更稳定的使用效果。
当然，形成在第一表面231和第二表面232的立体多孔结构层5的厚度也可以不同，根据第二髓针假体2所适用的患者的不同可进行具体的设计，例如当患者骨长入能力较差时，为了保证第二髓针假体2的强度，可将第一表面231的立体多孔结构层5的厚度设置的相比于第二表面232的立体多孔结构层5的厚度更厚。而当患者自身的骨爬行能力较差时，为了保证第二髓针假体1的固定的稳定性，可将第二表面232的立体多孔结构层5的厚度设置的相比于第一表面231的立体多孔结构层5的厚度更厚。
在如图5所示的实施例中，弧形表面23可连接在凹形球面211与针状部22的中部的外周壁之间。通过该设置，使形成在弧形表面23的立体多孔结构层5在能够满足趾骨4的更好的骨长入和更快的骨爬行的前提下，节约了立体多孔结构层5的材料，避免造成浪费。当然，弧形表面23也可连接在凹形球面211与针状部22的中上部的外周壁之间，或者连接在凹形球面211与针状部22的中下部的外周壁之间，其具体设置可根据不同患者的病患需求进行设定，以满足患者的个体化的差异。
优选地，针状部22的外表面可构造为粗糙面。即针状部22位于弧形表面23的外部的外表面可构造为粗糙面。针状部22在趾骨4的髓腔41内可通过骨水泥进行固定。通过该设置，使得针状部22的外表面具有更大的接触面积，有助于骨水泥将针状部22与趾骨4的髓腔41更牢固的固定在一起。
如图3和图5所示，优选地，第一髓针11、第二髓针12以及多孔立体结构层5可一体成型，和/或第二髓针假体2与多孔立体结构层5可一体成型。其中，立体多孔结构层5可由金属粉末制成，该金属粉末可以是钛合金、纯钛或钽金属等。优选地，立体多孔结构层5由钛合金材料制成，优选由Ti6Al4V制成。第一髓针11、第二髓针12以及第二髓针假体2也均可由钛合金材料制成。通过一体成型的加工方式不仅使第一髓针假体1和第二髓针假体2的加工更方便，同时还降低了第一髓针假体1和第二髓针假体2的各部件之间的相互作用力，从而使第一髓针假体1和第二髓针假体2的整体结构更稳定，力学强度更好。
根据本发明，如图3所示，第二髓针12的侧壁上还形成有贯穿第二髓针12的第一缝线孔122，铰接头14的靠近第二髓针12的一端上形成有贯穿铰接 头14的第二缝线孔143。当人体的脚趾关节因遭遇肿瘤或者粉碎性骨折等情况需要修复时，往往容易造成脚趾关节严重的骨缺损，严重的骨缺损容易导致脚趾关节处的关节囊损坏。通过上述设置，可将软组织缝合在第一缝线孔122与第二缝线孔143之间以修复或重建破损的关节囊，从而利于患者的术后恢复。
优选地，形成在第二髓针12上的第一缝线孔122可为多个，形成在铰接头14上的第二缝线孔143也可为多个。进一步优选地，如图3所示，形成在第二髓针12上的第一缝线孔122的个数可等于形成在铰接头14上的第二缝线孔143的个数，且各第一缝线孔122与各第二缝线孔143均靠近脚趾关节100的外侧。优选地，各第一缝线孔122与各第二缝线孔143均排列在同一竖直线上，以便使通过第一缝线孔122与第二缝线孔143缝合的关节囊与人体的关节囊更为相似，以便在植入趾关节假体100后进一步提升其运动机能。
还优选地，第一缝线孔122和第二缝线孔143的直径范围可为2.5mm至4mm；进一步地，第一缝线孔122和第二缝线孔143具体为沿相应的孔的轴向弯曲的通孔，该具有弯曲的弧度的通孔的轴向的长度范围可为2.5mm至40mm。该具体的长度值可根据缝合过程中使用的缝合弯针的直径以及缝合弯针的弯曲的弧度确定，以便于手术的操作和软组织更好的缝合。
最后应说明的是，以上技术方案同样适用于当趾关节假体100应用于患者的掌趾关节的置换的情况，即当趾关节假体100为掌趾关节假体时，只需将该趾关节假体100的第一髓针假体1用于与掌骨相连，第二髓针假体2用于与指骨相连，以替代上述技术方案中提到的跖骨和趾骨即可，这里不再赘述。
根据本发明的趾关节假体的制作方法，包括以下步骤：
第一、在第一髓针和/或第二髓针和/或第二髓针假体的外表面形成立体多孔结构层；
第二、将第一髓针设置在骨髓腔内，将第二髓针设置在骨髓腔外部，将第一髓针和第二髓针相连，构成第一髓针假体；
第三、将第一髓针假体和第二髓针假体铰接，构成趾关节假体。
进一步地，所述趾关节假体为脚趾关节假体，其中，所述第一髓针假体用于与跖骨相连，所述第二髓针假体用于与趾骨相连，所述第一髓针位于所述跖骨的髓腔内部，所述第二髓针位于所述跖骨的髓腔外部且与所述跖骨的端面抵接。
进一步地，所述趾关节假体为掌趾关节假体，其中，所述第一髓针假体用于与掌骨相连，所述第二髓针假体用于与指骨相连，所述第一髓针位于所述掌 骨的髓腔内部，所述第二髓针位于所述掌骨的髓腔外部且与所述掌骨的端面抵接。
进一步地，在第一步骤中，在第一髓针和/或第二髓针和/或第二髓针假体的外表面形成立体多孔结构层的具体步骤包括：
采用显微CT对第一髓针和/或第二髓针和/或第二髓针假体进行三维扫描，并采用MIMICS对扫描的数据进行模型重建，以获得三维示意模型；
对三维示意模型进行区域划分，划分的各区域分别适应于同一种组织的不同长入要求，进一步调整各区域的孔隙的直径，以使不同的区域具有不同的孔隙率；
采用3D打印设备来生成第一髓针和/或第二髓针和/或第二髓针假体的实体模型，通过调整3D打印设备的focus offset参数使得生成的实体模型中的丝径的表面形成多个凸起，其中focus offset参数的取值范围为5.8mA至6.2mA。
进一步地，形成在所述第一髓针的外表面的所述立体多孔结构层中的各孔隙的平均直径大于形成在所述第二髓针的外表面的所述立体多孔结构层中的各孔隙的平均直径。
进一步地，所述第一髓针假体还包括与所述第二髓针固定连接的铰接头，所述铰接头的朝向所述第二髓针假体的一端构造为球形面，所述第二髓针假体包括球形凹部，所述球形凹部的朝向所述铰接头的端面构造为与所述球形面配合的凹形球面。
进一步地，所述第二髓针假体还包括与所述球形凹部相连的针状部，所述球形凹部还包括连接在所述凹形球面与所述针状部的外周壁之间的向外突出的弧形表面，所述立体多孔结构层形成在所述弧形表面上。
进一步地，所述球形凹部的弧形表面包括用于延伸进入髓腔内的第一表面和位于髓腔外的第二表面，其中，形成在所述第一表面上的立体多孔结构层的各孔隙的平均直径大于形成在所述第二表面上的立体多孔结构层中的各孔隙的平均直径。
进一步地，形成在所述第一表面上的立体多孔结构层的各孔隙的平均直径的范围为100μm至200μm，形成在所述第二表面上的立体多孔结构层中的各孔隙的平均直径的范围为200μm至400μm。
进一步地，所述第二髓针的侧壁上还形成有贯穿所述第二髓针的第一缝线 孔，所述铰接头的靠近所述第二髓针的一端上形成有贯穿所述铰接头的第二缝线孔。
进一步地，所述针状部的外表面构造为粗糙面。
进一步地，所述第一髓针、所述第二髓针以及所述多孔立体结构层一体成型，和/或，所述第二髓针假体与所述多孔立体结构层一体成型。
以上各实施例仅用以说明本发明的技术方案，而非对其限制；尽管参照前述各实施例对本发明进行了详细的说明，本领域的普通技术人员应当理解：其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分或者全部技术特征进行等同替换；而这些修改或者替换，并不使相应技术方案的本质脱离本发明各实施例技术方案的范围，其均应涵盖在本发明的权利要求和说明书的范围当中。尤其是，只要不存在结构冲突，各个实施例中所提到的各项技术特征均可以任意方式组合起来。本发明并不局限于文中公开的特定实施例，而是包括落入权利要求的范围内的所有技术方案。

Claims (24)

  1. 一种趾关节假体，其特征在于，该趾关节假体包括第一髓针假体和与所述第一髓针假体铰接的第二髓针假体，所述第一髓针假体包括用于设置在骨髓腔内的第一髓针和与所述第一髓针相连且位于骨髓腔外部的第二髓针，所述第二髓针与所述第二髓针假体铰接，其中，所述第一髓针和/或所述第二髓针和/或所述第二髓针假体的外表面形成有立体多孔结构层。
  2. 根据权利要求1所述的趾关节假体，其特征在于，所述趾关节假体为脚趾关节假体，其中，所述第一髓针假体用于与跖骨相连，所述第二髓针假体用于与趾骨相连，所述第一髓针位于所述跖骨的髓腔内部，所述第二髓针位于所述跖骨的髓腔外部且与所述跖骨的端面抵接。
  3. 根据权利要求1所述的趾关节假体，其特征在于，所述趾关节假体为掌趾关节假体，其中，所述第一髓针假体用于与掌骨相连，所述第二髓针假体用于与指骨相连，所述第一髓针位于所述掌骨的髓腔内部，所述第二髓针位于所述掌骨的髓腔外部且与所述掌骨的端面抵接。
  4. 根据权利要求1至3中任一项所述的趾关节假体，其特征在于，所述立体多孔结构层包括多条丝径和由多条丝径相互交错连接形成的多个孔隙，各孔隙相互连通，且各孔隙的平均直径不同，其中，各所述孔隙的平均直径范围为100μm至400μm，且所述立体多孔结构层的孔隙率的范围为50％至80％。
  5. 根据权利要求1至3中任一项所述的趾关节假体，其特征在于，形成在所述第一髓针的外表面的所述立体多孔结构层中的各孔隙的平均直径大于形成在所述第二髓针的外表面的所述立体多孔结构层中的各孔隙的平均直径。
  6. 根据权利要求1至3中任一项所述的趾关节假体，其特征在于，所述第一髓针假体还包括与所述第二髓针固定连接的铰接头，所述铰接头的朝向所述第二髓针假体的一端构造为球形面，所述第二髓针假体包括球形凹部，所述球形凹部的朝向所述铰接头的端面构造为与所述球形面配合的凹形球面。
  7. 根据权利要求6所述的趾关节假体，其特征在于，所述第二髓针假体还包括与所述球形凹部相连的针状部，所述球形凹部还包括连接在所述凹形球面与所述针状部的外周壁之间的向外突出的弧形表面，所述立体多孔结构层形成在所述弧形表面上。
  8. 根据权利要求7所述的趾关节假体，其特征在于，所述球形凹部的弧形表面包括用于延伸进入髓腔内的第一表面和位于髓腔外的第二表面，其中，形成在所述第一表面上的立体多孔结构层的各孔隙的平均直径大于形成在所述第二表面上的立体多孔结构层中的各孔隙的平均直径。
  9. 根据权利要求8所述的趾关节假体，其特征在于，形成在所述第一表面上的立体多孔结构层的各孔隙的平均直径的范围为100μm至200μm，形成在所述第二表面上的立体多孔结构层中的各孔隙的平均直径的范围为200μm至400μm。
  10. 根据权利要求6所述的趾关节假体，其特征在于，所述第二髓针的侧壁上还形成有贯穿所述第二髓针的第一缝线孔，所述铰接头的靠近所述第二髓针的一端上形成有贯穿所述铰接头的第二缝线孔。
  11. 根据权利要求7至10中任一项所述的趾关节假体，其特征在于，所述针状部的外表面构造为粗糙面。
  12. 根据权利要求1至3中任一所述的趾关节假体，其特征在于，所述第一髓针、所述第二髓针以及所述多孔立体结构层一体成型，和/或，所述第二髓针假体与所述多孔立体结构层一体成型。
  13. 一种趾关节假体的制作方法，其特征在于，包括以下步骤：
    第一、在第一髓针和/或第二髓针和/或第二髓针假体的外表面形成立体多孔结构层；
    第二、将第一髓针设置在骨髓腔内，将第二髓针设置在骨髓腔外部，将第一髓针和第二髓针相连，构成第一髓针假体；
    第三、将第一髓针假体和第二髓针假体铰接，构成趾关节假体。
  14. 根据权利要求13所述的趾关节假体的制作方法，其特征在于，所述趾关节假体为脚趾关节假体，其中，所述第一髓针假体用于与跖骨相连，所述第二髓针假体用于与趾骨相连，所述第一髓针位于所述跖骨的髓腔内部，所述第二髓针位于所述跖骨的髓腔外部且与所述跖骨的端面抵接。
  15. 根据权利要求13所述的趾关节假体的制作方法，其特征在于，所述趾关节假体为掌趾关节假体，其中，所述第一髓针假体用于与掌骨相连，所述第二髓针假体用于与指骨相连，所述第一髓针位于所述掌骨的髓腔内部，所述第二髓针位于所述掌骨的髓腔外部且与所述掌骨的端面抵接。
  16. 根据权利要求13至15中任一项所述的趾关节假体的制作方法，其特征在于，在第一步骤中，在第一髓针和/或第二髓针和/或第二髓针假体的外表面形成立体多孔结构层的具体步骤包括：
    采用显微CT对第一髓针和/或第二髓针和/或第二髓针假体进行三维扫描，并采用MIMICS对扫描的数据进行模型重建，以获得三维示意模型；
    对三维示意模型进行区域划分，划分的各区域分别适应于同一种组织的不同长入要求，进一步调整各区域的孔隙的直径，以使不同的区域具有不同的孔隙率；
    采用3D打印设备来生成第一髓针和/或第二髓针和/或第二髓针假体的实体模型，通过调整3D打印设备的focusoffset参数使得生成的实体模型中的丝径的表面形成多个凸起，其中focusoffset参数的取值范围为5.8mA至6.2mA。
  17. 根据权利要求13至15中任一项所述的趾关节假体的制作方法，其特征在于，形成在所述第一髓针的外表面的所述立体多孔结构层中的各孔隙的平均直径大于形成在所述第二髓针的外表面的所述立体多孔结构层中的各孔隙的平均直径。
  18. 根据权利要求13至15中任一项所述的趾关节假体的制作方法，其特征在于，所述第一髓针假体还包括与所述第二髓针固定连接的铰接头，所述铰接头的朝向所述第二髓针假体的一端构造为球形面，所述第二髓针假体包括球形凹部，所述球形凹部的朝向所述铰接头的端面构造为与所述球形面配合的凹形球面。
  19. 根据权利要求18所述的趾关节假体的制作方法，其特征在于，所述第二髓针假体还包括与所述球形凹部相连的针状部，所述球形凹部还包括连接在所述凹形球面与所述针状部的外周壁之间的向外突出的弧形表面，所述立体多孔结构层形成在所述弧形表面上。
  20. 根据权利要求19所述的趾关节假体的制作方法，其特征在于，所述球形凹部的弧形表面包括用于延伸进入髓腔内的第一表面和位于髓腔外的第二表面，其中，形成在所述第一表面上的立体多孔结构层的各孔隙的平均直径大于形成在所述第二表面上的立体多孔结构层中的各孔隙的平均直径。
  21. 根据权利要求20所述的趾关节假体的制作方法，其特征在于，形成在所述第一表面上的立体多孔结构层的各孔隙的平均直径的范围为100μm至200μm，形成在所述第二表面上的立体多孔结构层中的各孔隙的平均直径的范围为200μm至400μm。
  22. 根据权利要求21所述的趾关节假体的制作方法，其特征在于，所述第二髓针的侧壁上还形成有贯穿所述第二髓针的第一缝线孔，所述铰接头的靠近所述第二髓针的一端上形成有贯穿所述铰接头的第二缝线孔。
  23. 根据权利要求19至21中任一项所述的趾关节假体的制作方法，其特征在于，所述针状部的外表面构造为粗糙面。
  24. 根据权利要求13至15中任一所述的趾关节假体的制作方法，其特征在于， 所述第一髓针、所述第二髓针以及所述多孔立体结构层一体成型，和/或，所述第二髓针假体与所述多孔立体结构层一体成型。
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