WO2021208229A1 - 一种髋臼骨缺损块、髋关节置换系统及手术方法 - Google Patents

一种髋臼骨缺损块、髋关节置换系统及手术方法 Download PDF

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WO2021208229A1
WO2021208229A1 PCT/CN2020/097125 CN2020097125W WO2021208229A1 WO 2021208229 A1 WO2021208229 A1 WO 2021208229A1 CN 2020097125 W CN2020097125 W CN 2020097125W WO 2021208229 A1 WO2021208229 A1 WO 2021208229A1
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Prior art keywords
acetabular
bone defect
acetabular bone
defect block
block
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PCT/CN2020/097125
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English (en)
French (fr)
Inventor
尚希福
胡森元
丁玉宝
许书富
宋雪峰
石亚民
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天津正天医疗器械有限公司
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Publication of WO2021208229A1 publication Critical patent/WO2021208229A1/zh

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    • 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
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4601—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • 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
    • A61F2/32—Joints for the hip
    • A61F2/34—Acetabular cups
    • 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
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • 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
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4609—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of acetabular cups
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30772—Apertures or holes, e.g. of circular cross section
    • A61F2002/30784—Plurality of holes

Definitions

  • the invention belongs to the technical field of prostheses implanted in the acetabulum, and in particular relates to an acetabular bone defect block, a hip joint replacement system and an operation method.
  • acetabular prosthesis requires multi-point support from the surrounding bone to obtain initial stability, the reconstruction of acetabular bone defects is an acetabular prosthesis.
  • a prerequisite for long-term body stability, acetabular bone defect is a difficult, time-consuming, and costly part of the initial or revision operation of the hip joint in such patients.
  • the traditional solution is to use a larger acetabular cup or use a reinforcement system on the acetabular side plus bone cement to fill the defect.
  • a larger defect is required.
  • the use of a larger acetabular cup results in the need to grind a lot of acetabular bone during the operation, which is not conducive to the recovery of the hip joint.
  • the reinforcement system on the acetabular side and bone cement are often used to fill the defect in the hip.
  • the acetabular fixation is unstable, and it is easy to cause revision surgery of the hip joint in the short term.
  • acetabular bone defect block product for filling acetabular bone defects on the market.
  • the product is specifically a quarter of the spherical block, but a single product can only be applied to the acetabulum. If you apply it to the inner side of the acetabulum, you need to combine at least two pieces of the product.
  • the product is not easy to fix in the acetabular socket.
  • the operation of implanting it into the acetabular socket with instruments is also more complicated. . Therefore, the existing operation methods in the field are complicated to operate, the existing products are not easy to fix in the acetabular socket, and more bone loss will be caused by implanting the prosthesis.
  • the present invention is proposed in order to solve the problems existing in the prior art, and its purpose is to provide a simple operation, the acetabular bone defect block can be automatically adapted to the acetabular cup for easy installation, and the acetabular defect socket and the acetabular cup are attached Good fit, can reduce the amount of bone loss during implantation, and the universal acetabular bone defect block, hip replacement system and surgical method.
  • An acetabular bone defect block comprising a defect block body including an inner surface and an outer surface protruding in the same direction, the inner surface being compatible with the outer surface of an acetabular cup, and the outer surface being compatible with the acetabulum
  • the bone defect surface is compatible, and the inner surface and the outer surface are independently larger than half of the arc surface.
  • the outer surface includes a central arc surface and an outer ring surface surrounding the central arc surface, the central arc surface is adapted to the outer surface of the acetabulum, the outer ring surface is an arc surface, and the outer ring surface The surface is adapted to the bone surface at the joint position of the acetabular defect.
  • the inner surface and the outer surface are independently arc surfaces, preferably circular arc surfaces, and the outer surface is preferably a hemispherical surface; the central axis of the inner surface and the outer surface coincide.
  • the difference between the diameter of the ball where the outer surface is located and the diameter of the ball where the inner surface is located is not more than 4 mm, and the distance between the inner surface and the outer surface is not more than 20 mm.
  • the thickness of the defect block body gradually decreases from the center of the arc surface to the edge.
  • the inner surface edge and the outer surface edge are connected by a transition section, and the transition section is preferably a circular arc section.
  • the defective block body includes a body layer and a bonding layer covering the outer surface of the body layer.
  • the defect block body is provided with a through hole extending from the inner surface to the outer surface, and the outer surface of the defect block body is fixedly connected to the acetabulum through at least one through hole by a fastener.
  • the through holes are set to be several evenly distributed on the body of the defective block.
  • At least one of the through holes is adapted to the acetabular cup mounting hole, and a fastener passes through the through holes and the acetabular cup mounting hole to fix the defect block body and the acetabular cup.
  • a bone cement fixing structure is provided on the inner surface; and/or,
  • a plurality of avoiding grooves are arranged on the edge of the body of the defective block.
  • the bone cement fixing structure is a bone cement groove, and the bone cement grooves are evenly distributed on the inner surface at multiple places with the same depth.
  • the bone cement tank is connected through a connecting groove.
  • the present invention also provides a hip joint replacement system, which includes at least one acetabular bone defect block as described above.
  • the present invention also provides a surgical method using the acetabular bone defect block as described above, and the method includes the following steps:
  • step (1) also includes step (1a) and optional step (1b) before step (1), and step (1b) is performed after step (1a):
  • the first acetabular bone defect block is fixed;
  • the fixation in step (3) includes bone cement fixation and/or fastener fixation.
  • the acetabular bone defect block and hip joint replacement system provided by the present invention due to the arc setting of the inner surface and the outer surface of the acetabular bone defect block used, are adapted to the outer surface of the acetabular cup and the acetabular bone defect surface respectively,
  • the inner surface and the outer surface are independently larger than half of the arc surface, and the amount of bone loss during the operation is small; and it can ensure that the acetabular bone defect block or the acetabular bone defect block trial model and the acetabular cup or acetabular cup trial model are automatically tested It is suitable for fitting, and the risk of turning during fitting is small, and it can be firmly fixed to the acetabular defect.
  • the acetabular bone defect block is especially suitable for the internal acetabular defect; in addition, it is convenient for the combination of the defect block and the acetabular cup to be implanted in the acetabulum.
  • the acetabular bone defect block and hip joint replacement system provided by the present invention directly fill the acetabular bone defect block at the position of the acetabular bone defect, which can not only ensure the stability of the acetabular bone defect block, but also ensure the implanted acetabulum
  • the stability of the cup means that the implanted acetabular bone defect block can be more stably located in the acetabular bone defect position, and the implanted acetabular cup can be more stably located in the acetabular fossa.
  • the outer surface of the acetabular bone defect block is adapted to the surface of the acetabular bone defect, and a suitable type of defect block can be selected according to the size of the acetabular bone defect, which has a higher
  • the versatility of the acetabular bone defect block makes the patient's bone loss smaller during surgery; the difference between the diameter of the outer arc of the acetabular bone defect block and the diameter of the inner arc is not more than 4mm, which minimizes the bone loss.
  • the edge of the inner surface and the edge of the outer surface can be connected by a transition section, which facilitates the implantation of the acetabular bone defect block without forming with the acetabular bone or the acetabular cup put one's oar in.
  • the joint layer is in contact with the surface of the acetabular bone defect, which is beneficial to biological bone ingrowth or bone lengthening.
  • the defect block body is provided with a through hole, which is convenient for fasteners to pass through the through hole to fix the acetabular bone defect block and the acetabulum, and facilitate the connection between the defect block and the hip. Bone cement is injected between the cups.
  • the bone cement groove on the inner surface can be filled with bone cement, so that the acetabular bone defect block and the acetabular cup are combined and fastened, thereby avoiding the installation of the acetabular cup
  • the holes are aligned with the through holes provided on the acetabular bone defect block and corresponding surgical operations; the bone cement grooves are connected through the connecting grooves, which facilitates the even distribution of bone cement.
  • the design of the acetabular defect block and the avoidance groove in the hip joint replacement system provided by the present invention is beneficial to avoid the influence of the defect block on the fixation of the acetabular cup.
  • Figure 1 is a perspective view of a first type of acetabular bone defect block provided by an embodiment of the present invention
  • FIG. 2 is a top view of the first type of acetabular bone defect block provided by an embodiment of the present invention
  • FIG. 3 is a cross-sectional view of the first type of acetabular bone defect block provided by an embodiment of the present invention.
  • FIG. 4 is a perspective view of a first type of acetabular bone defect block provided by an embodiment of the present invention.
  • Figure 5 is a top view of a second type of acetabular bone defect block provided by an embodiment of the present invention.
  • Figure 6 is a right side view of a second type of acetabular bone defect block provided by an embodiment of the present invention.
  • Figure 7 is a left view of a second type of acetabular bone defect block provided by an embodiment of the present invention.
  • Fig. 8 is a top view of a third type of acetabular bone defect block provided by an embodiment of the present invention.
  • Fig. 9 is a side view of a third type of acetabular bone defect block provided by an embodiment of the present invention.
  • Figure 10 is a superimposed schematic diagram of two acetabular bone defect blocks provided by an embodiment of the present invention.
  • Fig. 11 is an X-ray image of two acetabular bone defect blocks after being superimposed and implanted in the acetabulum according to an embodiment of the present invention.
  • An acetabular bone defect block as shown in Figures 1-4, includes a defect block body 1, which includes an inner surface 2 and an outer surface 3 protruding in the same direction, the inner surface 2 and the hip
  • the outer surface of the acetabular cup is compatible, the outer surface 3 is compatible with the surface of the acetabular bone defect, and the inner surface and the outer surface are independently larger than half of the arc surface.
  • the half of the curved surface means that the surface passing through the center of the curved surface cuts the curved surface into two identical parts, and one part of the curved surface is half of the curved surface.
  • the center of the arcuate surface refers to the center of the sphere where the arcuate surface is located.
  • the acetabular bone defect block can be in any shape ranging from more than half of the arc to the entire arc, for example, it can be 2/3 of the arc (passing the center of the arc, dividing the arc into the same three parts, where The two parts are the 2/3 surface of the arc), the surface of the arc 3/4 (the arc is divided into the same four parts through the center of the arc, and the three parts are the surface of the arc 3/4), The surface of the arc 5/6 (passing the center of the arc, dividing the arc into the same six parts, five of which are the 5/6 of the arc) or the entire arc, etc.
  • the inner surface 2 and the outer surface 3 can independently adopt an approximate hemispherical structure, an approximate 1/3 spherical structure, an approximate 3/8 spherical structure (as shown in Figure 5, Figure 6 and Figure 7) or approximately 3/ 7Spherical structure, etc., make the present invention adapt to different shapes of acetabular bone defects.
  • the shape of the inner surface 2 and the outer surface 3 can be different.
  • the inner surface 2 can be adjusted in proportion to the outer surface of the acetabulum, using approximately 1/3 spherical surface or approximately 2/5 spherical surface.
  • the spherical structure makes the inner surface 2 fit with the outer surface of the acetabular cup, and the outer surface 3 fits with the surface of the acetabular bone defect.
  • the outer surface 3 may include a central arc surface 31 and an outer ring surface 32 surrounding the central arc surface. 31 is adapted to the outer surface of the acetabulum, the outer ring surface 32 is a curved surface, and the outer ring surface 32 is adapted to the bone surface at the joint position of the acetabular defect.
  • the outer surface 3 of the acetabular bone defect block is compatible with most acetabular bone defects, and the amount of bone lost during grinding is small, and the present invention can adapt to acetabular bone defects of different areas and shapes, and the inner surface 2 is adapted to On the outer surface of the acetabular cup and the inner surface of the acetabulum, the outer surface 3 is adapted to the surface of the acetabular bone defect, so that the acetabular bone defect block and the acetabular cup can be fixed in the acetabular socket.
  • the inner surface of the acetabulum described in the present invention is the inner surface of the acetabular socket, that is, the surface in contact with or opposite to the acetabular cup, and the outer surface of the acetabulum is the outer surface of the acetabular socket.
  • the arc design of the inner and outer surfaces is adapted to the outer surface of the acetabular cup and the surface of the acetabular bone defect.
  • the outer surface and the inner surface are arc surfaces protruding in the same direction, and the axes of the inner surface and the outer surface coincide.
  • the outer surface is a hemispherical surface (as shown in Figs. 1 to 4).
  • the acetabular bone defect can be frustrated with a small amount of bone to form a spherical defect suitable for the implant of the present invention, and the amount of bone loss is small, and the conventional acetabulum is used It can be completed by frustration, the operation is simple, and the versatility is strong.
  • the outer surface and the inner surface are arc surfaces protruding in the same direction, and when the axis of the inner surface coincides with the outer surface, the automatic fitting effect of the acetabular bone defect block and the acetabular cup is the best, compared to the acetabular bone defect block
  • the inner and outer surfaces of the acetabular bone defect block are independently between more than half the arc and the entire arc (not including the entire arc), which can avoid the acetabulum when the acetabular cup or the acetabular cup trial mold is driven into the acetabulum
  • the risk of bone defect block turnover and the disadvantage of not being easy to fix on the bone surface; in addition, the outer surface and inner surface of the acetabular bone defect block are arc surfaces protruding in the same direction, and the axis of the inner surface and the outer surface coincide, After manufacturing the defect block and the acetabular cup cavity, determine the relative position of the defect block and the acetabular cup through the trial model.
  • the position of the defect block can be accurately found and the defect block can be buckled to the hip
  • bone cement can be injected into the joint surface of the acetabular cup and the defect through the hole of the defect block. Because there is no risk of overturning in the buckle, the combination of the defect block and the acetabular cup can be easily inserted into the production. In the cavity, the acetabular cup and the defect block are implanted, and the operation stability is strong.
  • the acetabular bone defect block and the defect block refer to the same.
  • the present invention can be designed in different sizes and models, which can be applied to larger areas of acetabular bone defects as well as For local acetabular bone defects with a small area, it can also be used for acetabular bone defects penetrating the acetabular fossa. It has strong versatility, but it is preferably used for acetabular bone defects with a small area.
  • the difference between the diameter of the ball where the outer arc surface (ie outer surface 3) is located and the diameter of the ball where the inner arc surface (ie inner surface 2) is located is not more than 4mm, such as 1mm, 2mm, or 2.3. mm, 3.5mm or 3.8mm, etc.
  • the diameter difference within this range can ensure that the bone loss at the position of the acetabular bone defect is minimized.
  • the distance between the inner surface 2 and the outer surface 3 of the acetabular bone defect block (that is, the thickness of the defect block) is not greater than 20 mm, such as 5 mm, 8 mm, 12 mm, 15 mm, 18 mm, or 19.5 mm.
  • the thickness of the defect block body gradually decreases from the center of the arc surface to the edge. That is, the middle thickness of the acetabular bone defect block is thin.
  • the diameter of the outer arc surface (ie, the outer surface 3) of the acetabular bone defect block is in the range of 4.0cm-7.0cm, such as 4.2cm, 4.5cm, 5.8cm, 6.0cm, 6.2 cm or 6.7 cm, etc., and those skilled in the art can adjust the diameter range as required.
  • the edge of the inner surface and the edge of the outer surface can be directly connected, but the connection part is relatively sharp when directly connected.
  • the edge of the inner surface and the edge of the outer surface are designed to be connected by a transition section
  • the transition section is preferably a circular arc section.
  • the transition section functions to connect the edges of the inner surface and the outer surface, so that the edges of the inner surface smoothly transition to the edges of the outer surface.
  • the size of the transition section should be significantly smaller than the size of the inner surface or the outer surface.
  • the area of the transition section is much smaller than the area of the inner surface or the outer surface.
  • the area of the transition section can be the area of the inner surface.
  • the edge of the inner surface 2 and the edge of the outer surface 3 are connected by an arc segment 5, which facilitates the implantation of the present invention at any position of the acetabular bone defect, and does not form the acetabular bone and the acetabular cup. Intervention is conducive to postoperative recovery.
  • the thickness of the transition section ranges from 1.5mm to 2.5mm, such as 1.8mm, 2.0mm, 2.2mm or 2.4mm.
  • the defect block body 1 includes a body layer 7 and a bonding layer 8 covering the outer surface 3 side of the body layer 7.
  • the bonding layer 8 is in contact with the surface of the acetabular bone defect, and the bonding layer 8 is
  • the bio-porous surface or the coated surface is made of materials that facilitate bone ingrowth, which is conducive to the ingrowth of biological bones or bone growth.
  • the body layer 7 is made of a material that can be implanted into the human body.
  • the bonding layer 8 is made of titanium alloy or hydroxyapatite or tantalum metal trabecular bone, and the body layer 7 is made of titanium alloy.
  • the thickness of the bonding layer 8 is 250 ⁇ m-1500 ⁇ m, such as 280 ⁇ m, 300 ⁇ m, 500 ⁇ m, 800 ⁇ m, 1000 ⁇ m, or 1200 ⁇ m, etc.
  • the thickness range is favorable for biological bone growth or bone growth.
  • the defect block body 1 is provided with a through hole 6 extending from the inner surface 2 to the outer surface 3, and the outer surface 3 of the defect block body 1 is fixed to the acetabulum through at least one through hole 6 by a fastener. Connected, the through hole 6 is also used to inject bone cement between the inner surface of the acetabular bone defect block and the outer surface of the acetabular cup.
  • the edge of the acetabular bone defect block can also be provided with a plurality of avoiding grooves 11, that is, the acetabular bone defect block is star-shaped (as shown in the figure). 8 to Figure 9).
  • the through hole 6 can be a screw hole or a light hole.
  • the acetabular screw of the standard acetabular cup can be used to pass through the through hole 6 and the acetabulum to fix the defect block body 1 on the bone surface of the acetabular bone defect.
  • the use of acetabular screws as fasteners can reduce the types of parts. Reduce manufacturing costs and simplify operations.
  • the through hole 6 can be a countersunk hole, so that the head of the fastener is not higher than the surface of the inner surface 2 so that the inner surface 2 and the surface of the acetabular cup are evenly and firmly connected.
  • the through holes 6 are set to be several evenly distributed on the defective block body 1, such as 2, 3, 5, or 7, etc. There are several through holes 6 to facilitate selection of suitable through holes 6 to fix the acetabular bone defect block on the surface of the acetabular bone during surgery; several through holes 6 are evenly distributed on the defect block body 1 for implantation during surgery
  • the acetabular bone defect block brings convenience.
  • the number of through holes 6 is 5; in addition, the through holes 6 facilitate the injection of bone cement between the inner surface of the acetabular bone defect block and the outer surface of the acetabular cup.
  • the through hole 6 is provided in the center of the defect block body 1, and the through hole 6 is a screw hole, which is convenient for connecting the implantation device and accurately moving the acetabular bone defect block. Further, when there are multiple through holes, preferably one through hole is arranged in the center of the acetabular bone defect block, and the remaining through holes are evenly distributed around the through hole arranged in the center.
  • At least one of the through holes 6 is adapted to the acetabular cup mounting hole, so that fasteners can be used to pass through the acetabular cup mounting hole on the acetabular cup and the through hole 6 to connect the acetabular bone defect block with The acetabular cup is fixedly connected.
  • the inner surface 2 is provided with a bone cement fixing structure 4, which facilitates better bonding of the bone cement when the bone cement is applied to the inner surface 2 and better fixation of the acetabulum
  • the bone defect block is fixed to the acetabular cup, which simplifies the processing and manufacturing of the inner surface 2 of the defect block body 1.
  • the use of fasteners to fix the acetabular cup on the acetabular bone defect is avoided , That is, when the bone cement fixing structure is set, the acetabular bone defect block and the acetabular cup only need to be fixed with bone cement, without screw fixation.
  • the bone cement fixing structure 4 may be a bone cement groove.
  • the bone cement grooves are uniformly distributed on the inner surface 2 and have multiple locations with the same depth. There are multiple bone cement grooves to make the inner surface 2 and the bone cement adhere to a large area to ensure that the acetabular bone defect block and the acetabular cup are firmly combined; multiple bone cement grooves are evenly distributed on the inner surface 2, making the inner surface 2 and The bone cement is evenly connected; the depth of the bone cement groove is uniform, which is convenient for the processing of the bone cement groove.
  • the form of the bone cement tank can be a circular groove, a strip groove, and the like.
  • the bone cement grooves can be connected to each other through the connecting grooves (the connecting grooves are not shown in FIGS. 1 to 4).
  • This embodiment also provides a hip joint replacement system, which includes at least one acetabular bone defect block as described above, and the hip joint replacement system also includes an acetabular cup and a femoral stem required for surgery, which can be based on the needs of the surgery. Select the desired implant or implant equipment, etc.
  • the outer surface of the combination of multiple acetabular bone defect blocks used in superimposition should be adapted to the surface of the acetabular bone defect, and the inner surface should be compatible with the acetabular cup.
  • the outer surface is adapted; the outer surface of the superimposed acetabular bone defect block is adapted to the inner surface of the superimposed bone defect block.
  • the hip joint replacement system includes the acetabular bone defect block in the above technical solution, it has the beneficial effects of the acetabular bone defect block described above, which will not be repeated here.
  • the at least one refers to two (as shown in Figure 10 and Figure 11), three or four acetabular bone defect blocks that can be superimposed or combined to meet the needs of different patients, and the number of superimposed or combined Determined according to different needs.
  • the superimposed or combined multiple acetabular defect blocks can be relatively arbitrarily rotated, and is not limited to the angle shown in FIG. 10 or FIG. 11, and the actual rotation angle is subject to surgical requirements.
  • the surgical method using the acetabular bone defect block as described above, the method includes the following steps:
  • the multiple means at least two unless otherwise specified.
  • step (1) before step (1), it also includes step (1a) and optional step (1b), and step (1b) is performed after step (1a):
  • the first acetabular bone defect block is fixed before the one or more second acetabular bone defect blocks are superimposed with the first acetabular bone defect block in step (2).
  • the fixation may be bone cement fixation and/or fastener fixation.
  • the first acetabular bone defect piece can be used with titanium mesh, which is located between the acetabulum and the first hip Between the bone defects of the acetabulum, it plays a role of holding the bone defect of the first acetabulum.
  • the fixation in step (3) includes bone cement fixation and/or fastener fixation.
  • the surgical method using the acetabular bone defect block as described above when only one acetabular defect block is used, the preferred surgical method includes:
  • the surgical method is similar to the above-mentioned surgical method, and the preferred surgical method includes:
  • acetabular bone defect block and acetabular cup Fix the acetabular bone defect block and acetabular cup as needed; or, replace the acetabular bone defect block trial model and/or acetabular cup trial model with the acetabular bone defect block and/or acetabular cup and replace the hip
  • the acetabular defect block and the acetabular cup are fixed; the fixation is fixed with fasteners and/or bone cement.
  • the fastener may be an acetabular screw or the like.
  • the acetabular bone defect block and hip joint replacement system provided by the present invention due to the arc setting of the inner surface and the outer surface of the acetabular bone defect block used, are adapted to the outer surface of the acetabular cup and the acetabular bone defect surface respectively,
  • the inner surface and the outer surface are independently larger than half of the arc surface, which can ensure that the acetabular bone defect block or acetabular bone defect block trial model is automatically matched with the acetabular cup or acetabular cup trial model, and there is a risk of flipping during the fitting It is small and can be firmly fixed to the acetabular defect.
  • the operation and difficulty are greatly simplified, and the combination of the acetabular bone defect block and the fixation required by the combination are avoided; the acetabulum
  • the bone defect block is especially suitable for the defect of the medial acetabulum; in addition, it is convenient for the combination of the defect block and the acetabular cup to be implanted in the acetabulum.
  • the acetabular bone defect block and hip joint replacement system provided by the present invention directly fill the acetabular bone defect block at the position of the acetabular bone defect, which can not only ensure the stability of the acetabular bone defect block, but also ensure the implanted acetabulum
  • the stability of the cup means that the implanted acetabular bone defect block can be more stably located in the acetabular bone defect position, and the implanted acetabular cup can be more stably located in the acetabular fossa.
  • the outer surface of the acetabular bone defect block is adapted to the surface of the acetabular bone defect, and a suitable type of defect block can be selected according to the size of the acetabular bone defect, which has a higher
  • the versatility of the acetabular bone defect block makes the patient's bone loss smaller during the operation; the diameter difference between the outer arc surface and the inner arc surface of the acetabular bone defect block is not more than 4mm, which minimizes the bone loss.
  • the edge of the inner surface and the edge of the outer surface can be connected by a transition section, which facilitates the implantation of the acetabular bone defect block without forming with the acetabular bone or the acetabular cup put one's oar in.
  • the joint layer is in contact with the surface of the acetabular bone defect, which is beneficial to biological bone ingrowth or bone lengthening.
  • the defect block body is provided with a through hole, which is convenient for fasteners to pass through the through hole to fix the acetabular bone defect block and the acetabulum, and facilitate the connection between the defect block and the hip. Bone cement is injected between the cups.
  • the bone cement groove on the inner surface can be filled with bone cement, so that the acetabular bone defect block and the acetabular cup are combined and fastened, thereby avoiding the installation of the acetabular cup
  • the holes are aligned with the through holes provided on the acetabular bone defect block and corresponding surgical operations; the bone cement grooves are connected through the connecting grooves, which facilitates the even distribution of bone cement.
  • the design of the acetabular defect block and the avoidance groove in the hip joint replacement system provided by the present invention is beneficial to avoid the influence of the defect block on the fixation of the acetabular cup.
  • the present invention After tests, for hip replacement surgery, the present invention has a good use effect on cases of initial or revision acetabular bone defects, has strong versatility, and has stable performance from initial stability to long-term bone ingrowth, and no additional addition is required.
  • the implanted device is easy to operate.

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Abstract

一种髋臼骨缺损块、髋关节置换系统及手术方法，该髋臼骨缺损块包括缺损块本体（1），缺损块本体（1）包括朝同一方向凸出的内表面（2）和外表面（3），内表面（2）与髋臼杯外表面相适应，外表面（3）与髋臼骨缺损表面相适应，内表面（2）和外表面（3）独立地为大于弧面一半的面。提供的髋臼骨缺损块及手术方法能够减少植入时的骨丢失量，在手术时能够自动与髋臼杯或髋臼杯试模适配，便于植入操作，便于安装，大大降低了手术难度及节约了手术时间，与髋臼骨缺损窝及髋臼杯贴敷性强，更好的维持内植入假体的稳定。

Description

一种髋臼骨缺损块、髋关节置换系统及手术方法 技术领域
本发明属于植入髋臼的假体技术领域，尤其涉及一种髋臼骨缺损块、髋关节置换系统及手术方法。
背景技术
髋关节手术中，经常会遇到髋臼部分存在较大面积缺损的病例，由于髋臼假体需要周围骨质的多点支撑方可获得初始稳定性，髋臼骨缺损的重建是髋臼假体长期稳定的前提，髋臼骨缺损是该类患者髋关节初次或翻修术中处理困难、耗时长、出血多、花费大的部分。
对于髋臼骨较大面积缺损的处理，传统的解决方案是使用更大的髋臼杯或者使用髋臼侧的加强系统加骨水泥填补缺损，但使用前一方案时，对于较大的缺损需要使用更大的髋臼杯，进而导致手术时需磨削掉很多的髋臼骨质，不利于髋关节的恢复；使用后一方案时，髋臼侧的加强系统加骨水泥填补缺损往往在髋臼上固定不稳，且容易造成短期内的髋关节翻修手术。
针对传统处理方法的不足，目前市场上出现了用于填补髋臼骨缺损的髋臼骨缺损块产品，该产品具体为四分之一的球面块，但单个的该产品只能应用于髋臼缘部位，如果将其应用于髋臼内侧，则需要将至少两块该产品进行组合，该产品不易固定在髋臼窝内，另外，使用器械将其植入髋臼窝内的操作也较为复杂。因此，本领域的现有操作方法操作复杂，现有产品不易固定在髋臼窝内，且由于植入假体会导致更多骨量丢失。
发明内容
本发明为解决现有技术存在的问题而提出，其目的是提供一种操作简单，髋臼骨缺损块能够与髋臼杯自动适配以便于安装，且与髋臼缺损窝和髋臼杯贴合性好，能够减少植入时的骨丢失量及通用性强的髋臼骨缺损块、髋关节置换系统及手术方法。
本发明的技术方案是：
一种髋臼骨缺损块，包括缺损块本体，所述缺损块本体包括朝同一方向凸出的内表面和外表面，所述内表面与髋臼杯外表面相适应，所述外表面与髋臼骨缺损表面相适应，内表面和外表面独立地为大于弧面一半的面。
进一步地，所述外表面包括中心弧面和环绕所述中心弧面的外环面，所述中心弧面与所述髋臼外表面相适应，所述外环面为弧面，所述外环面与髋臼缺损接合位置的骨表面相适应。
进一步地，所述内表面与外表面独立地为弧面，优选为圆弧面，外表面优选为半球面；内表面与外表面的中轴线重合。
进一步地，外表面所在球的直径与内表面所在球的直径之差不大于4mm，内表面与外表面间的距离不大于20mm。
进一步地，所述缺损块本体的厚度从弧面中心至边缘逐渐减小。
进一步地，所述内表面边缘和外表面边缘通过过渡段连接，所述过渡段优选为圆弧段。
进一步地，所述缺损块本体包括本体层和覆盖于所述本体层外表面侧的接合层。
进一步地，所述缺损块本体上设有从内表面延伸到外表面的通孔，缺损块本体的外表面通过紧固件穿过至少一个所述通孔与髋臼固定连接。
进一步地，所述通孔设为在所述缺损块本体上均匀分布的数个。
进一步地，至少一个所述通孔与髋臼杯安装孔相适应，紧固件穿过所述通孔和髋臼杯安装孔将缺损块本体与髋臼杯固定连接。
进一步地，所述内表面上设有骨水泥固定结构；和/或，
所述缺损块本体边缘设置有多个避让槽。
进一步地，所述骨水泥固定结构为骨水泥槽，所述骨水泥槽为均匀分布于内表面且深度一致的多处。
优选地，所述骨水泥槽通过连接槽连通。
本发明还提供了一种髋关节置换系统，包括至少一个如上所述的髋臼骨缺损块。
本发明还提供了一种使用如上所述髋臼骨缺损块的手术方法，所述方法包括如下步骤：
(1)将合适型号的第一髋臼骨缺损块植入髋臼骨缺损中；
(2)将合适型号的髋臼杯打入髋臼中；或，
将一个或多个第二髋臼骨缺损块与第一髋臼骨缺损块叠合，之后在髋臼中打入合适型号的髋臼杯；
(3)根据需要将第一髋臼骨缺损块、第二髋臼骨缺损块或髋臼杯固定。
进一步地，步骤(1)之前还包括步骤(1a)和可选的步骤(1b)，步骤(1b)在步骤(1a)后进行：
(1a)检查髋臼骨缺损形状，如果髋臼骨缺损的骨表面不是球面缺损，将其处理成球面缺损；如果髋臼骨缺损的骨表面是球面缺损，则不必调整骨表面；
(1b)选择合适型号的第一髋臼骨缺损块试模、第二髋臼骨缺损块试模或髋臼杯试模中的任一种或至少两种，打入髋臼骨缺损和/或髋臼中，以确定第一髋臼骨缺损块、第二髋臼骨缺损块和髋臼杯中的任一种或至少两种的型号和位置。
进一步地，步骤(2)所述将一个或多个第二髋臼骨缺损块与第一髋臼骨缺损块叠合之前，先将第一髋臼骨缺损块固定；
优选地，步骤(3)所述固定包括骨水泥固定和/或紧固件固定。
本发明提供的髋臼骨缺损块及髋关节置换系统，由于使用的髋臼骨缺损块中内表面及外表面的弧面设置及分别与髋臼杯外表面和髋臼骨缺损表面相适应，内表面和外表面独立地为大于弧面一半的面，手术时的骨丢失量小；且能够确保髋臼骨缺损块或髋臼骨缺损块试模与髋臼杯或髋臼杯试模自动适配，且适配时翻转风险小，能够稳固固定于髋臼缺损处，相对于传统手术方法的人工标记适配，大大简化了手术操作和难度，且避免了髋臼骨缺损块的组合及组合 需要的固定；所述髋臼骨缺损块尤其适用于髋臼内侧缺损；另外，便于缺损块和髋臼杯组合后植入髋臼中。
本发明提供的髋臼骨缺损块及髋关节置换系统，直接将髋臼骨缺损块填充在髋臼骨缺损位置，不但能够确保髋臼骨缺损块的稳定，还能保证植入后的髋臼杯的稳定，即植入后的髋臼骨缺损块能够较稳定地位于髋臼骨缺损位置中，植入后的髋臼杯能够较稳定地位于髋臼窝中。
本发明提供的髋臼骨缺损块及髋关节置换系统，髋臼骨缺损块的外表面与髋臼骨缺损表面相适应，可根据髋臼骨缺损的大小选择合适型号的缺损块，具有较高的通用性，且使得手术时患者的骨量丢失较小；髋臼骨缺损块的外弧面所在球的直径与内弧面所在球的直径之差不大于4mm，使得骨量丢失最小。
本发明提供的髋臼骨缺损块及髋关节置换系统，内表面的边缘和外表面的边缘能够通过过渡段连接，便于髋臼骨缺损块的植入而不与髋臼骨或髋臼杯形成干涉。
本发明提供的髋臼骨缺损块及髋关节置换系统，接合层与髋臼骨缺损表面接触，有利于生物骨长入或骨长上。
本发明提供的髋臼骨缺损块及髋关节置换系统，缺损块本体设有通孔，便于紧固件穿过通孔将髋臼骨缺损块与髋臼固定连接，以及便于向缺损块与髋臼杯之间注入骨水泥。
本发明提供的髋臼骨缺损块及髋关节置换系统，内表面上的骨水泥槽内可填充骨水泥，使得髋臼骨缺损块与髋臼杯结合紧固，从而避免了髋臼杯的安装孔与髋臼骨缺损块设置的通孔的对准及相应的手术操作；骨水泥槽之间通过连接槽连通，便于骨水泥分布均匀。
本发明提供的髋臼骨缺损块及髋关节置换系统中避让槽的设计有利于避免缺损块对髋臼杯固定的影响。
附图说明
图1是本发明一种实施方式提供的第一种型式的髋臼骨缺损块的立体图；
图2是本发明一种实施方式提供的第一种型式的髋臼骨缺损块的俯视图；
图3是本发明一种实施方式提供的第一种型式的髋臼骨缺损块的剖视图；
图4是本发明一种实施方式提供的第一种型式的髋臼骨缺损块的立体图；
图5是本发明一种实施方式提供的第二种型式的髋臼骨缺损块的俯视图；
图6是本发明一种实施方式提供的第二种型式的髋臼骨缺损块的右视图；
图7是本发明一种实施方式提供的第二种型式的髋臼骨缺损块的左视图；
图8是本发明一种实施方式提供的第三种型式的髋臼骨缺损块的俯视图。
图9是本发明一种实施方式提供的第三种型式的髋臼骨缺损块的侧视图。
图10是本发明一种实施方式提供的两个髋臼骨缺损块的叠加示意图；
图11是本发明一种实施方式提供的两个髋臼骨缺损块叠加植入髋臼后的X-射线图像。
其中：1、缺损块本体；2、内表面；3、外表面；31、中心弧面；32、外环面；4、骨水泥固定结构；5、圆弧段；6、通孔；7、本体层；8、接合层；9、第一种型式的髋臼骨缺损块；10、第二种型式的髋臼骨缺损块；11、避让槽。
具体实施方式
以下，参照附图和实施例对本发明进行详细说明：
一种髋臼骨缺损块，如图1-4所示，包括缺损块本体1，所述缺损块本体1包括朝同一方向凸出的内表面2和外表面3，所述内表面2与髋臼杯外表面相适应，所述外表面3与髋臼骨缺损表面相适应，内表面和外表面独立地为大于弧面一半的面。
所述弧面一半的面是指过弧面中心的面将弧面截成相同的两部分，其中一部分即为弧面一半。所述弧面中心是指弧面所在球的球心。
所述髋臼骨缺损块可以是介于大于弧面一半至整个弧面的任意形状，如可以是弧面2/3的面(过弧面中心，将弧面分割成相同的三部分，其中两部分即为弧面2/3的面)、弧面3/4的面(过弧面中心，将弧面分割成相同的四部分，其中三部分即为弧面3/4的面)、弧面5/6的面(过弧面中心，将弧面分割成相同 的六部分，其中五部分即为弧面5/6的面)或是整个弧面等。进一步地，内表面2和外表面3独立地可采用近似半球面结构、近似1/3球面结构、近似3/8的球面结构(如图5、图6和图7所示)或近似3/7球面结构等，使本发明适应不同形状的髋臼骨缺损。另外，内表面2和外表面3形状可不同，如外表面3采用近似半球面结构时，内表面2可根据髋臼外表面调整比例，采用近似1/3球面或近似2/5球面等比例的球面结构，使内表面2与髋臼杯外表面相适应，外表面3与髋臼骨缺损表面相适应。
为了适用于髋臼骨缺损穿透髋臼窝的情况，如图4所示，所述外表面3可包括中心弧面31和环绕所述中心弧面的外环面32，所述中心弧面31与所述髋臼外表面相适应，所述外环面32为弧面，所述外环面32与髋臼缺损接合位置的骨表面相适应。
所述髋臼骨缺损块的外表面3与大部分髋臼骨缺损相适应，使用时磨削丢失的骨量少，且本发明可适应不同面积、形状的髋臼骨缺损，内表面2适应于髋臼杯的外表面及髋臼内表面，外表面3适应于髋臼骨缺损表面，便于髋臼骨缺损块及髋臼杯固定在髋臼窝内。
本发明中所述的髋臼内表面为髋臼窝内侧表面，即与髋臼杯接触或相对的表面，髋臼外表面为髋臼窝外侧表面。
内表面及外表面的弧面设计、分别与髋臼杯外表面和髋臼骨缺损表面相适应及内表面和外表面独立地为大于弧面一半的面，能够确保髋臼骨缺损块在髋臼杯或髋臼杯试模打入髋臼时自动与髋臼杯或髋臼杯试模适配(髋臼杯或髋臼杯试模打入前，髋臼骨缺损块由于其外表面的设计，其一侧可能会突出到髋臼骨缺损外部，髋臼杯或髋臼杯试模打入时会对髋臼骨缺损块施加一个作用力，使得髋臼骨缺损块与髋臼骨缺损及髋臼杯外表面自动贴合)，避免了髋臼骨缺损块的组合，简化了手术操作和手术难度，节约了手术时间。
优选所述外表面和内表面为朝同一方向凸出的圆弧面，且内表面与外表面的轴线重合，最优选的方案是外表面为半球面(如图1至图4)。当髋臼骨缺损 表面不为球面缺损时，可使用髋臼挫将髋臼骨缺损挫去少量骨质形成适于本发明植入的球面缺损，骨质丢失量少，且使用常规的髋臼挫即可完成，操作简单，通用性强。外表面和内表面为朝同一方向凸出的圆弧面，且内表面与外表面的轴线重合时髋臼骨缺损块与髋臼杯的自动适配效果最好，相对于髋臼骨缺损块的内表面和外表面独立地介于大于弧面一半至整个弧面之间(不包括整个弧面)的髋臼骨缺损块，能够避免髋臼杯或髋臼杯试模打入时髋臼骨缺损块翻转的风险和不易稳固固定于骨表面的缺点；另外髋臼骨缺损块的外表面和内表面为朝同一方向凸出的圆弧面，且内表面与外表面的轴线重合时，在制作完成缺损块及髋臼杯型腔，通过试模确定好缺损块与髋臼杯的相对位置，将试模替换为假体后，可精确找到缺损块的位置并将缺损块扣于髋臼杯的表面，通过缺损块的孔可将骨水泥注入于髋臼杯与缺损块的结合面位置，因扣合无翻转风险，可将缺损块与髋臼杯的组合体轻松打入制作好的型腔内，完成髋臼杯与缺损块的植入，手术操作的稳定性强。
本发明中髋臼骨缺损块与缺损块所指相同。
进一步地，为进一步减少髋臼骨磨削及提高所述髋臼骨缺损块的通用性，本发明可设计为不同的尺寸型号，既可适用于较大面积的髋臼骨缺损，也可适用于面积较小的局部髋臼骨缺损，也能用于穿透髋臼窝的髋臼骨缺损，具备较强的通用性，但优选用于面积较小的髋臼骨缺损。
作为优选的技术方案，所述外圆弧面(即外表面3)所在球的直径与内圆弧面(即内表面2)所在球的直径差不大于4mm，如可为1mm、2mm、2.3mm、3.5mm或3.8mm等。所述直径差在此范围内能够保证髋臼骨缺损位置的骨量丢失最少。
所述髋臼骨缺损块的内表面2和外表面3间的距离(即缺损块厚度)不大于20mm，如5mm、8mm、12mm、15mm、18mm或19.5mm等。优选所述缺损块本体的厚度从弧面中心至边缘逐渐减小。即所述髋臼骨缺损块中间厚边缘薄，该设计便于填补髋臼缺损，确保外表面贴合髋臼骨缺损表面，内表面贴合髋臼 杯外表面，且便于髋臼骨缺损块与髋臼杯外表面自动适配。
作为优选的技术方案，所述髋臼骨缺损块的外圆弧面(即外表面3)所在球的直径范围为4.0cm-7.0cm，如4.2cm、4.5cm、5.8cm、6.0cm、6.2cm或6.7cm等，本领域技术人员可根据需要调整所述直径范围。
进一步地，所述内表面的边缘和外表面的边缘可直接连接，但直接连接时连接部位比较尖锐，为便于患者术后恢复，因此设计为内表面的边缘与外表面的边缘通过过渡段连接，该过渡段优选为圆弧段。所述过渡段起到连接内表面和外表面的边缘的作用，使得内表面的边缘圆滑过渡到外表面的边缘。本领域技术人员应知，所述过渡段的尺寸应明显小于内表面或外表面的尺寸，如过渡段的面积远远小于内表面面积或外表面面积，如过渡段的面积可以为内表面面积或外表面面积的1/100～1/10，如1/10、1/20、1/50或1/80等。如图1至图3所示，所述内表面2边缘和外表面3边缘通过圆弧段5连接，便于本发明植入任意髋臼骨缺损位置，且对髋臼骨和髋臼杯不形成干涉，有利于术后恢复。优选过渡段的厚度范围为1.5mm至2.5mm，如1.8mm、2.0mm、2.2mm或2.4mm等。
进一步，如图3所示，所述缺损块本体1包括本体层7和覆盖于所述本体层7外表面3侧的接合层8，接合层8与髋臼骨缺损表面接触，接合层8为生物多孔面或涂层面，采用便于骨长入的材质，有利于生物骨长入或骨长上。本体层7采用可植入人体的材质。优选的，所述接合层8采用钛合金或羟基磷灰石或钽金属骨小梁制造，所述本体层7采用钛合金制造。进一步，接合层8厚度为250μm-1500μm，如280μm、300μm、500μm、800μm、1000μm或1200μm等，在此厚度范围内有利于生物骨长入或骨长上。
进一步，所述缺损块本体1上设有从内表面2延伸到外表面3的通孔6，缺损块本体1的外表面3经紧固件穿过至少一个所述通孔6与髋臼固定连接，所述通孔6还用于向髋臼骨缺损块内表面和髋臼杯外表面之间注入骨水泥。为了便于髋臼杯与髋臼骨缺损块及髋臼固定在一起，所述髋臼骨缺损块的边缘还可 设置多个避让槽11，即所述髋臼骨缺损块为海星状(如图8至图9所示)。通孔6可设为螺孔或光孔。安装时，可使用标准髋臼杯的髋臼螺钉穿过通孔6和髋臼将缺损块本体1固定在髋臼骨缺损位置的骨表面，紧固件采用髋臼螺钉可减少零配件种类，降低制造成本，简化操作。进一步，该通孔6可采用沉头孔，使紧固件头部不高于所述内表面2表面，使内表面2与髋臼杯表面均匀牢固连接。
进一步，所述通孔6设为在所述缺损块本体1上均匀分布的数个，如2个、3个、5个或7个等。通孔6设有数个，便于手术时根据需要选择合适的通孔6将髋臼骨缺损块固定在髋臼骨表面；数个通孔6在缺损块本体1上均匀分布，为手术时植入髋臼骨缺损块带来便利。优选的，通孔6数量为5个；另外，所述通孔6便于在髋臼骨缺损块内表面和髋臼杯外表面之间注入骨水泥。
优选的，所述缺损块本体1中央位置设有所述通孔6，且所述通孔6为螺孔，便于连接植入器械，精确移动该髋臼骨缺损块。进一步地，当通孔有多个时，优选髋臼骨缺损块中央设置有1个通孔，其余通孔围绕中央设置的通孔均匀分布。
进一步，优选至少一个所述通孔6与髋臼杯安装孔相适应，以便于使用紧固件穿过髋臼杯上的髋臼杯安装孔和所述通孔6将髋臼骨缺损块与髋臼杯固定连接。
进一步，如图1至图4所示，所述内表面2上设有骨水泥固定结构4，便于向内表面2上涂覆骨水泥时更好的结合骨水泥，并更好地将髋臼骨缺损块与髋臼杯固定，简化了缺损块本体1中内表面2的加工制造，另外，由于骨水泥固定结构的设置，避免了使用紧固件将髋臼杯固定在髋臼骨缺损处，即当设置骨水泥固定结构时，髋臼骨缺损块与髋臼杯仅需骨水泥固定即可，无需螺钉固定。
进一步，如图1至图4所示，所述骨水泥固定结构4可为骨水泥槽，优选的，所述骨水泥槽为均匀分布于内表面2且深度一致的多处。骨水泥槽设有多处，使内表面2与骨水泥粘接面积大，保证髋臼骨缺损块与髋臼杯结合牢固；多处骨水泥槽均匀分布于内表面2，使内表面2与骨水泥均匀连接；骨水泥槽深 度一致，便于骨水泥槽的加工。骨水泥槽形式可为圆形槽、条形槽等。为了注入的骨水泥能够在髋臼骨缺损内表面及髋臼杯外表面之间均匀分布，可将骨水泥槽通过连接槽相互连通(图1-图4中未示出连接槽)。
本实施例还提供了一种髋关节置换系统，包括至少一个如上所述的髋臼骨缺损块，所述髋关节置换系统还包括手术所需的髋臼杯及股骨柄等，可根据手术需要选择所需的植入物或植入器械等。
本领域技术人员应知，当所述髋臼骨缺损块叠加使用时，叠加使用的多个髋臼骨缺损块组合的外表面应与髋臼骨缺损表面适应，内表面应与髋臼杯的外表面相适应；叠加的髋臼骨缺损块的外表面与被叠加的骨缺损块的内表面相适应。
由于该髋关节置换系统包括上述技术方案中的髋臼骨缺损块，因而具有上述髋臼骨缺损块的有益效果，此处不再赘述。所述至少一个是指可以包括叠加或组合的两个(如图10和图11所示)、三个或四个等髋臼骨缺损块，以满足不同患者的需要，叠加或组合的个数根据不同的需要确定。所述叠加或组合的多个髋臼缺损块可以相对任意旋转，不局限于图10或图11所示的角度，实际旋转角度以手术需要为准。
使用如上所述髋臼骨缺损块的手术方法，所述方法包括如下步骤：
(1)将合适型号的第一髋臼骨缺损块植入髋臼骨缺损中；
(2)将合适型号的髋臼杯打入髋臼中；或，
将一个或多个第二髋臼骨缺损块与第一髋臼骨缺损块叠合，之后在髋臼中打入合适型号的髋臼杯；
(3)根据需要将第一髋臼骨缺损块、第二髋臼骨缺损块或髋臼杯固定。
所述多个如无特殊说明均是指至少两个。
作为优选的技术方案，上述手术方法中，步骤(1)之前还包括步骤(1a)和可选的步骤(1b)，步骤(1b)在步骤(1a)后进行：
(1a)检查髋臼骨缺损形状，如果髋臼骨缺损的骨表面不是球面缺损，将 其处理成球面缺损；如果髋臼骨缺损的骨表面是球面缺损，则不必调整骨表面；
(1b)选择合适型号的第一髋臼骨缺损块试模、第二髋臼骨缺损块试模或髋臼杯试模中的任一种或至少两种，打入髋臼骨缺损和/或髋臼中，以确定第一髋臼骨缺损块、第二髋臼骨缺损块和髋臼杯中的任一种或至少两种的型号和位置。
作为优选的技术方案，步骤(2)所述将一个或多个第二髋臼骨缺损块与第一髋臼骨缺损块叠合之前，先将第一髋臼骨缺损块固定。所述固定可为骨水泥固定和/或紧固件固定。当髋臼存在贯穿性缺损，且第一髋臼骨缺损块通过骨水泥固定在髋臼骨缺损中时，第一髋臼骨缺损块可配合钛网使用，钛网位于髋臼与第一髋臼骨缺损块之间，起到兜住第一髋臼骨缺损块的作用。
优选地，步骤(3)所述固定包括骨水泥固定和/或紧固件固定。
具体地，使用如上所述的髋臼骨缺损块的手术方法，当仅适用一个髋臼缺损块时，优选的手术方法包括：
(1)检查髋臼骨缺损形状，如果髋臼骨缺损的骨表面不是球面缺损，将其处理成球面缺损；如果髋臼骨缺损的骨表面是球面缺损，则不必调整骨表面；
(2)选择合适型号的髋臼骨缺损块或髋臼骨缺损块试模，将其植入球面缺损中；
(3)选择合适型号的髋臼杯或髋臼杯试模将其打入髋臼内，打入髋臼杯/髋臼杯试模的同时髋臼骨缺损块与髋臼杯自动适配；
(4)根据需要固定髋臼骨缺损块和髋臼杯；或，将髋臼骨缺损块试模和/或髋臼杯试模替换为髋臼骨缺损块和/或髋臼杯后将髋臼骨缺损块和髋臼杯固定；所述固定为使用紧固件固定和/或骨水泥固定。
本领域技术人员可根据实际情况选择试模或假体。
当使用两个髋臼骨缺损块时，所述手术方法与上述手术方法相似，优选的手术方法包括：
(1)检查髋臼骨缺损形状，如果髋臼骨缺损的骨表面不是球面缺损，将其 处理成球面缺损；如果髋臼骨缺损的骨表面是球面缺损，则不必调整骨表面；
(2)选择合适型号的第一髋臼骨缺损块或第一髋臼骨缺损块试模，将其打入球面缺损中，如选择髋臼骨缺损块，则打入后进行固定；
(3)选择合适型号的第二髋臼骨缺损块或第二髋臼骨缺损块试模将其与第一髋臼骨缺损块适配；
(4)将髋臼杯或髋臼杯试模打入髋臼内，打入髋臼杯或髋臼杯试模的同时第二髋臼骨缺损块或第二髋臼骨缺损块试模与髋臼杯或髋臼杯试模自动适配；
(5)根据需要固定髋臼骨缺损块和髋臼杯；或，将髋臼骨缺损块试模和/或髋臼杯试模替换为髋臼骨缺损块和/或髋臼杯后将髋臼骨缺损块和髋臼杯固定；所述固定为使用紧固件固定和/或骨水泥固定。所述紧固件可为髋臼螺钉等。
手术操作者可以根据实际情况选择试模或假体。
本发明提供的髋臼骨缺损块及髋关节置换系统，由于使用的髋臼骨缺损块中内表面及外表面的弧面设置及分别与髋臼杯外表面和髋臼骨缺损表面相适应，内表面和外表面独立地为大于弧面一半的面，能够确保髋臼骨缺损块或髋臼骨缺损块试模与髋臼杯或髋臼杯试模自动适配，且适配时翻转风险小，能够稳固固定于髋臼缺损处，相对于传统手术方法的人工标记适配，大大简化了手术操作和难度，且避免了髋臼骨缺损块的组合及组合需要的固定；所述髋臼骨缺损块尤其适用于髋臼内侧缺损；另外，便于缺损块和髋臼杯组合后植入髋臼中。
本发明提供的髋臼骨缺损块及髋关节置换系统，直接将髋臼骨缺损块填充在髋臼骨缺损位置，不但能够确保髋臼骨缺损块的稳定，还能保证植入后的髋臼杯的稳定，即植入后的髋臼骨缺损块能够较稳定地位于髋臼骨缺损位置中，植入后的髋臼杯能够较稳定地位于髋臼窝中。
本发明提供的髋臼骨缺损块及髋关节置换系统，髋臼骨缺损块的外表面与髋臼骨缺损表面相适应，可根据髋臼骨缺损的大小选择合适型号的缺损块，具有较高的通用性，且使得手术时患者的骨量丢失较小；髋臼骨缺损块的外弧面 与内弧面的直径差不大于4mm，使得骨量丢失最小。
本发明提供的髋臼骨缺损块及髋关节置换系统，内表面的边缘和外表面的边缘能够通过过渡段连接，便于髋臼骨缺损块的植入而不与髋臼骨或髋臼杯形成干涉。
本发明提供的髋臼骨缺损块及髋关节置换系统，接合层与髋臼骨缺损表面接触，有利于生物骨长入或骨长上。
本发明提供的髋臼骨缺损块及髋关节置换系统，缺损块本体设有通孔，便于紧固件穿过通孔将髋臼骨缺损块与髋臼固定连接，以及便于向缺损块与髋臼杯之间注入骨水泥。
本发明提供的髋臼骨缺损块及髋关节置换系统，内表面上的骨水泥槽内可填充骨水泥，使得髋臼骨缺损块与髋臼杯结合紧固，从而避免了髋臼杯的安装孔与髋臼骨缺损块设置的通孔的对准及相应的手术操作；骨水泥槽之间通过连接槽连通，便于骨水泥分布均匀。
本发明提供的髋臼骨缺损块及髋关节置换系统中避让槽的设计有利于避免缺损块对髋臼杯固定的影响。
经试验，对于髋关节置换手术，本发明对初次或翻修髋臼骨缺损的病例具有良好的使用效果，通用性强，从初期稳定性到长期的骨长入均性能稳定，且不需要额外增加植入器械，操作方便。
以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本发明的保护范围之内。

Claims (10)

  1. 一种髋臼骨缺损块，其特征在于，包括缺损块本体(1)，所述缺损块本体(1)包括朝同一方向凸出的内表面(2)和外表面(3)，内表面(2)与髋臼杯外表面相适应，外表面(3)与髋臼骨缺损表面相适应，内表面(2)和外表面(3)独立地为大于弧面一半的面。
  2. 如权利要求1所述的髋臼骨缺损块，其特征在于，所述内表面(2)与外表面(3)独立地为圆弧面，且内表面(2)与外表面(3)的轴线重合；
    优选地，外表面所在球的直径与内表面所在球的直径差不大于4mm；
    优选地，所述内表面与外表面间的距离不大于20mm；
    优选地，所述缺损块本体(1)的厚度从弧面中心至边缘逐渐减小；
    优选地，所述内表面(2)边缘和外表面(3)边缘通过过渡段连接。
  3. 如权利要求1或2所述的髋臼骨缺损块，其特征在于，所述缺损块本体(1)包括本体层(7)和覆盖于所述本体层(7)外表面(3)侧的接合层(8)。
  4. 如权利要求1-3之一所述的髋臼骨缺损块，其特征在于，所述缺损块本体(1)上设有从内表面(2)延伸到外表面(3)的通孔(6)，缺损块本体(1)通过紧固件穿过至少一个所述通孔(6)与髋臼固定连接。
  5. 如权利要求1-4之一所述的髋臼骨缺损块，其特征在于，所述内表面(2)上设有骨水泥固定结构(4)；和/或，
    所述缺损块本体边缘设置有多个避让槽(11)。
  6. 如权利要求5所述的髋臼骨缺损块，其特征在于，所述骨水泥固定结构(4)为骨水泥槽，所述骨水泥槽为均匀分布于内表面且深度一致的多处；
    优选地，骨水泥槽通过连接槽连通。
  7. 一种髋关节置换系统，其特征在于，包括至少一个如权利要求1至权利要求6中任一项所述的髋臼骨缺损块。
  8. 一种使用权利要求1-6之一所述髋臼骨缺损块的手术方法，其特征在于，所述方法包括如下步骤：
    (1)将合适型号的第一髋臼骨缺损块植入髋臼骨缺损中；
    (2)将合适型号的髋臼杯打入髋臼中；或，
    将一个或多个第二髋臼骨缺损块与第一髋臼骨缺损块叠合，之后在髋臼中打入合适型号的髋臼杯；
    (3)根据需要将第一髋臼骨缺损块、第二髋臼骨缺损块或髋臼杯固定。
  9. 根据权利要求8所述的手术方法，其特征在于，步骤(1)之前还包括步骤(1a)和可选的步骤(1b)，步骤(1b)在步骤(1a)后进行：
    (1a)检查髋臼骨缺损形状，如果髋臼骨缺损的骨表面不是球面缺损，将其处理成球面缺损；如果髋臼骨缺损的骨表面是球面缺损，则不必调整骨表面；
    (1b)选择合适型号的第一髋臼骨缺损块试模、第二髋臼骨缺损块试模或髋臼杯试模中的任一种或至少两种，打入髋臼骨缺损和/或髋臼中，以确定第一髋臼骨缺损块、第二髋臼骨缺损块和髋臼杯中的任一种或至少两种的型号和位置。
  10. 根据权利要求8或9所述的手术方法，其特征在于，步骤(2)所述将一个或多个第二髋臼骨缺损块与第一髋臼骨缺损块叠合之前，先将第一髋臼骨缺损块固定；
    优选地，步骤(3)所述固定包括骨水泥固定和/或紧固件固定。
PCT/CN2020/097125 2020-04-16 2020-06-19 一种髋臼骨缺损块、髋关节置换系统及手术方法 WO2021208229A1 (zh)

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