Thumb carpometacarpal joint implant and use performance evaluation method thereof

Abstract

The invention discloses a thumb carpometacarpal joint implant and a use performance evaluation method thereof. The thumb carpometacarpal joint implant is used for being installed between a metacarpal bone and a trapezial bone of a human body. The hinge comprises a hinge piece and a matching piece. A joint curved surface which abuts against and is matched with the joint surface of the multi-corner bone is formed at one end of the hinging piece, and a ball head which is rotationally matched with the matching piece is formed at the other end of the hinging piece; the matching piece is used for being embedded and inserted into a marrow cavity of the metacarpal bone incision; the joint curved surface is connected with the ball head through a columnar structure, and the radial size, close to the ball head, of the columnar structure is smaller than that of the ball head. According to the technical scheme, the invention aims to provide the thumb carpometacarpal joint implant which keeps the bone mass of the trapezial bone to the maximum extent and is large in movement range.

Description

Technical Field

[0001] The invention relates to the field of joint prostheses, in particular to a thumb carpometacarpal joint implant and a method for evaluating the performance thereof. Background Art

[0002] In daily life, the thumb carpometacarpal joint is responsible for grasping the palm. It is also one of the most common sites of primary osteoarthritis. The prevalence of osteoarthritis in men and women is 7% and 15% respectively, and it is more common in middle-aged women. Pain is one of the common clinical symptoms of thumb carpometacarpal joint osteoarthritis.

[0003] At present, the common treatments for advanced thumb carpometacarpal osteoarthritis include thumb carpometacarpal fusion, trapezium resection, and thumb carpometacarpal replacement. Thumb carpometacarpal fusion can be used to treat thumb carpometacarpal arthritis Eaton II and III, with good results, but the thumb movement is limited after surgery, the joint melted area does not heal, and it is easy to develop scaphoid enlargement, trapezium osteoarthritis, and thumb metacarpophalangeal arthritis. Trapezium resection is suitable for thumb carpometacarpal arthritis Eaton II, III, and IV. After trapezium resection, its short-term efficacy is satisfactory, but there are often problems such as unstable thumb force and weakened strength. Thumb carpometacarpal replacement can immediately eliminate pain, maintain the stability of the first carpal metacarpal, improve joint flexibility, and improve the strength of the thumb, which has attracted widespread attention. At present, the commonly used thumb carpometacarpal joint in the world is to install an acetabular cup on the trapezium. This type of prosthesis removes a lot of bone, and the loosening rate after about 5 years of implantation is 15%. Summary of the invention

[0004] The purpose of the present invention is to provide a thumb carpometacarpal joint implant and a method for evaluating its performance, aiming to reduce the amount of bone removal during prosthesis installation, expand the flexibility and range of motion of the carpometacarpal joint prosthesis, and improve the user experience.

[0005] To achieve this object, the present invention adopts the following technical solutions: A thumb carpometacarpal joint implant is used to be installed between the metacarpal bone and trapezium of a human body; it comprises a hinge part and a matching part; One end of the hinged member is formed with an articular curved surface that abuts against the articular surface of the trapezium, and the other end is formed with a ball head that rotatably cooperates with the matching member; the matching member is used to be inserted into the bone marrow cavity of a cut in the metacarpal bone; The joint curved surface is connected to the ball head via a columnar structure, and a radial dimension of the columnar structure close to the ball head is smaller than a radial dimension of the ball head.

[0006] In one embodiment, the fitting comprises an insertion handle and a liner, wherein the liner is embedded in the insertion handle and forms a pestle-and-mortise socket, and the pestle-and-mortise socket cooperates with the ball head to form a pestle-and-mortise joint prosthesis.

[0007] In one embodiment, the insertion handle forms an installation groove for installing the liner, the side wall of the installation groove is provided with a recess, and the outer wall of the liner is provided with a convex portion; the convex portion can be engaged with the recess to fix the liner relative to the insertion handle.

[0008] In one embodiment, the pestle-mortise socket is respectively composed of a concave spherical surface and an inclined curved surface connected to the concave spherical surface, and the inclined curved surface is used to avoid the columnar structure so as to expand the rotation range of the hinge relative to the matching part.

[0009] In one embodiment, the mating piece includes an insertion handle, and the cross-section of the insertion handle near the ball head end is a triangular surface.

[0010] In one embodiment, the cross-sectional area of ​​the insertion handle gradually decreases from the proximal ball head end to the distal ball head end.

[0011] In one embodiment, a porous biological structure is attached to the outer surface of the proximal ball head end of the insertion handle, and the surface of the distal ball head end of the insertion handle is polished.

[0012] The present invention also provides a method for evaluating the performance of a thumb carpometacarpal joint implant as described above, comprising the steps of: Resecting the metacarpal articular surface of a plurality of human body samples so that the metacarpal bone has an incision and the medullary cavity of the metacarpal bone is exposed; embedding the matching piece into the medullary cavity to complete the fixation of the matching piece; cleaning the articular surface of the trapezium to obtain a smooth and clean articular surface; The articular curved surface of the hinge is fitted with the articular surface of the trapezium; Under the condition that the hinge and the trapezium are relatively fixed, the matching piece is matched with the ball head by operating the metacarpal bone to obtain a plurality of human body samples using the thumb carpometacarpal joint implant; Obtaining physiological evaluation parameters of human body samples using the thumb carpometacarpal joint implant, grouping multiple samples into primary groups according to the same type of physiological evaluation parameters, and obtaining a group number for each primary group; Collect medical images of the thumb carpometacarpal joint implant used by each human sample at the same time interval to obtain the usage of the thumb carpometacarpal joint implant of each human sample; According to the usage of thumb carpometacarpal joint implants of each human sample, the human samples are grouped into secondary groups on the basis of the first grouping to obtain a good usage group and an abnormal usage group, and the ratio of the number of people in the good usage group to the number of people in the abnormal usage group under each group number is obtained; According to the group number of each primary grouping and the ratio of the number of people in the good use group to the number of people in the abnormal use group under each group number, a statistical chart is obtained; According to the statistical chart, the physiological evaluation parameters of the human body samples with a high proportion of good group using the thumb carpometacarpal joint implant are obtained; The performance of the thumb carpometacarpal joint implant is evaluated based on the characteristics or ranges of the physiological evaluation parameters of the human sample group.

[0013] In one embodiment, the physiological evaluation parameters of the human sample include one or more of a gender parameter, an age parameter, a bone density parameter, and a disease grade parameter; Accordingly, each first-level grouping includes one or more of a first group divided according to gender parameters, a second group divided according to age parameters, a third group divided according to bone density parameters, and a fourth group divided according to disease grade parameters; and each of the human samples is divided into first-level groups under different physiological evaluation parameters.

[0014] In one embodiment, before obtaining the usage of the thumb carpometacarpal joint implant of each human sample, the method further includes: collecting thumb range of motion parameters and thumb strength parameters of each human sample at the same time interval after using the thumb carpometacarpal joint implant; and / or, At the same time interval after using the thumb carpometacarpal joint implant, a questionnaire survey was designed to collect the subjective experience of each human sample.

[0015] Compared with the prior art, the present invention has the following beneficial effects: The technical solution of the present invention is provided with a hinge, and the hinge includes a joint curved surface, a columnar structure and a ball head connected in sequence. When the carpometacarpal joint of the human thumb is replaced, the joint curved surface and the trapezium can form a curved joint pair similar to the original carpometacarpal joint. Therefore, the trapezium with the hinge installed does not need osteotomy, thereby avoiding excessive influence on the thumb force. In addition, the trapezium retains its original joint surface structure, so that the implanted thumb carpometacarpal joint prosthesis is more in line with its original movement requirements. In a specific technical solution, when the implant of the thumb carpometacarpal joint implant of the technical solution of the present invention is performed in surgery, it is only necessary to remove the joint part of the metacarpal bone close to the trapezium, and expose the bone marrow cavity of the metacarpal bone, so as to install and fix the matching part that rotates with the ball head in the bone marrow cavity, so as to form another ball-and-socket joint pair (i.e., a spherical rotation pair) relative to the original thumb carpometacarpal joint. Therefore, the setting of the thumb carpometacarpal joint implant can only form a pair of joint pairs of prosthesis structures. The thumb carpometacarpal joint implant of the technical solution of the present invention can better ensure the flexibility of the finger joint after the implantation of the prosthesis.

[0016] It should also be noted that in the technical solution of this embodiment, the saddle surface is connected to the ball head through a columnar structure, and the radial dimension of the columnar structure close to the ball head is smaller than the radial dimension of the ball head. It can be understood that the setting of the columnar structure can enable the ball head and the mating part to form a spherical rotation pair, and make the circumferential rotation angle range consistent, thereby improving the stability of the thumb carpometacarpal joint implant in the human palm and the user experience of the human body. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

[0018] The structures, proportions, sizes, etc. illustrated in the drawings of this specification are only used to match the contents disclosed in the specification so as to facilitate understanding and reading by persons familiar with this technology. They are not used to limit the conditions under which the present invention can be implemented, and therefore have no substantive technical significance. Any structural modification, change in proportion or adjustment of size, without affecting the effects and purposes that can be achieved by the present invention, should still fall within the scope of the technical contents disclosed by the present invention.

[0019] Figure 1 It is a structural schematic diagram of an embodiment of a thumb carpometacarpal joint implant of the present invention; Figure 2It is a cross-sectional schematic diagram of an embodiment of a thumb carpometacarpal joint implant of the present invention; Figure 3 It is a structural schematic diagram of an embodiment of a hinge of the present invention; Figure 4 4a and 4b are cross-sectional views of an embodiment of the inner liner respectively; Figure 5 5a and 5b are cross-sectional views of an embodiment of an insert handle; Figure 6 A cross-sectional view of an embodiment of an insert handle of the present invention; Figure 7 A cross-sectional view of another embodiment of the insert handle of the present invention; Figure 8 8a and 8b are cross-sectional views of an embodiment of an insert handle; Illustration: 100, thumb carpometacarpal joint implant; 120, hinge; 121, joint surface; 122, ball head; 123, columnar structure; 130, matching piece; 131, insertion handle; 131a, mounting groove; 1312, recess; 132, lining; 132a, pestle-mortise fossa; 132a1, concave spherical surface; 132a2, inclined curved surface; 1322, convex part; 134, porous biological structure; 200, metacarpal bone; 200a, medullary cavity; 300, trapezium. DETAILED DESCRIPTION

[0020] In order to make the technical purpose, features and advantages of the present invention more obvious and easy to understand, the technical scheme in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the embodiments described below are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0021] In the description of the present invention, it should be understood that the terms "upper", "lower", "top", "bottom", "inside", "outside" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation of the present invention. It should be noted that when a component is considered to be "connected" to another component, it may be directly connected to the other component or there may be a centrally arranged component at the same time.

[0022] The technical solution of the present invention is further described below with reference to the accompanying drawings and through specific implementation methods.

[0023] An embodiment of the present invention provides a thumb carpometacarpal joint implant 100 .

[0024] See also Figure 1 , Figure 2 and Figure 3 In one embodiment of the present invention, the thumb carpometacarpal joint implant 100 is used to be installed between the metacarpal bone 200 and the trapezium 300 of the human body; the thumb carpometacarpal joint implant 100 includes a hinge 120 and a fitting 130; One end of the hinged member 120 is formed with an articular curved surface 121 that abuts against the articular surface of the trapezium 300, and the other end is formed with a ball head 122 that rotatably cooperates with the matching member 130; the matching member 130 is used to be inserted into the bone marrow cavity 200a of the incision of the metacarpal bone 200; The joint curved surface 121 is connected to the ball head 122 via a columnar structure 123 , and a radial dimension of the columnar structure 123 is smaller than a radial dimension of the ball head 122 .

[0025] It is understandable that the technical solution of the present invention is provided with a hinge 120, and the hinge 120 includes a joint curved surface 121, a columnar structure 123 and a ball head 122 connected in sequence. When replacing the carpometacarpal joint of the human thumb, the joint curved surface 121 and the trapezium 300 can form a curved joint pair similar to the original carpometacarpal joint. Therefore, the trapezium 300 equipped with the hinge 120 does not need osteotomy, thereby avoiding excessive influence on the thumb force. In addition, the trapezium 300 retains its original joint surface structure, so that the implanted thumb carpometacarpal joint prosthesis better meets its original movement requirements. In a specific technical solution, during the surgical installation of the thumb carpometacarpal joint implant 100 of the technical solution of the present invention, it is only necessary to remove the joint portion of the metacarpal bone 200 close to the trapezium 300 and expose the bone marrow cavity 200a of the metacarpal bone 200, so as to install and fix the matching piece 130 that rotates with the ball head 122 in the bone marrow cavity 200a, thereby forming another ball-and-socket joint pair (i.e., a spherical rotation pair) relative to the original thumb carpometacarpal joint. Therefore, the setting of the thumb carpometacarpal joint implant 100 can only form a prosthetic structure of a pair of joint pairs. The thumb carpometacarpal joint implant 100 of the technical solution of the present invention can better ensure the flexibility of the finger joint after the implantation of the prosthesis and expand the range of motion of the finger joint.

[0026] It should also be noted that in the technical solution of this embodiment, the joint surface 121 is connected to the ball head 122 via a columnar structure 123, and the radial dimension of the columnar structure 123 is smaller than the radial dimension of the ball head 122. It can be understood that the setting of the columnar structure 123 can enable the ball head 122 and the matching part 130 to form a spherical rotation pair, and make the circumferential rotation angle range consistent, thereby improving the stability of the thumb carpometacarpal joint implant 100 in the palm of the human body.

[0027] It should also be noted that the hinge 120 is usually made of a material with good biocompatibility and good wear resistance, such as polyetheretherketone, polyetheretherketone derivatives, polycarbonate, polyacetal, cobalt-chromium alloy, ceramics, etc.

[0028] It should also be noted that the articular curved surface 121 is used to cooperate with the articular surface of the original trapezium 300 of the patient or the articular surface of the trapezium 300 after surgical removal to form a curved joint pair. Therefore, the articular curved surface 121 can be designed according to the actual situation of the articular surface of the trapezium 300 of the patient. For example, the articular curved surface 121 is set to a concave curved surface, a potato chip-shaped curved surface, a saddle-shaped curved surface, etc., to cooperate with the articular surface of the trapezium 300.

[0029] Optionally, in order to save surgical costs and improve the reliability of the connection between the joint curved surface 121 prosthesis and the articular surface of the trapezium, the shape of the joint curved surface 121 is only set to a saddle surface shape. When installing the hinge 120, the articular surface of the trapezium 300 can be properly processed to ensure that its surface is flat and clean without excess bone scraps or soft tissue residue, so that the joint curved surface 121 prosthesis and the original articular surface can move smoothly, thereby completing effective cooperation with the trapezium 300.

[0030] It should also be noted that the material of the joint surface 121 has good wear resistance and low friction coefficient. Therefore, the prosthesis is arranged to cooperate with the joint surface of the original trapezium, which can reduce the friction on the bone joint, thereby alleviating the pain symptoms. At the same time, the technical solution of the present invention is also equipped with a pestle-and-mortar joint pair consisting of the ball head 122 and the matching piece 130, so that the joint prosthesis can perform smooth multi-directional movement and reduce the risk of displacement of the joint surface 121 prosthesis. And the pestle-and-mortar joint pair can better simulate the range of motion of the natural joint and provide multi-directional mobility. It is of great help in restoring the normal functions of the thumb such as grasping, pinching and rotating.

[0031] It should also be noted that, by utilizing the articular surface 121 to cooperate with the articular surface of the original trapezium 300, an incision is made in the metacarpal bone 200 to expose the medullary cavity 200a of the metacarpal bone 200 so that the fitting 130 can be fixed to the metacarpal bone 200. This type of surgery usually has a high repeatability and the related surgical techniques are relatively mature. Therefore, the provision of the thumb carpometacarpal joint implant can also improve the success rate of the surgery.

[0032] Optionally, the fitting 130 may be an acetabular cup having a concave spherical surface forming a spherical rotation pair with the ball head 122 .

[0033] Optionally, the fitting 130 is an insertion handle 131, which has a concave spherical surface that forms a spherical rotation pair with the ball head 122, and the length of the insertion handle 131 is greater than the length of the hinge 120, so that the connection between the insertion handle 131 and the medullary cavity 200a of the metacarpal bone 200 is more secure.

[0034] Please continue reading Figure 1 and Figure 2 In a specific embodiment of the present invention, the mating component 130 includes an insertion handle 131 and a liner 132, wherein the liner 132 is embedded in the insertion handle 131, and the liner 132 forms a pestle-and-mortise socket 132a, and the pestle-and-mortise socket 132a cooperates with the ball head 122 to form a pestle-and-mortise type joint prosthesis.

[0035] It is understandable that the configuration of the lining 132 provides different material options for the various components of the thumb carpometacarpal joint implant 100, and facilitates the configuration of different materials for the insertion handle 131 and the lining 132, so as to improve the service life of the thumb carpometacarpal joint implant 100. For example, in order to ensure the connection strength between the insertion handle 131 and the metacarpal bone 200, it is usually necessary to select a material with high mechanical strength. In order to reduce the wear of the lining 132 and the ball head 122, the material of the lining 132 usually needs to select a material with high wear resistance.

[0036] Optionally, the inserting handle 131 is made of biomaterials such as polyetheretherketone and its derivatives, titanium alloy, cobalt-chromium alloy or ceramics.

[0037] Optionally, the lining 132 is made of wear-resistant biomaterials such as ultra-high molecular weight polyethylene (including highly cross-linked ultra-high molecular weight polyethylene, ultra-high molecular weight polyethylene containing antioxidants and highly cross-linked ultra-high molecular weight polyethylene), polyetheretherketone, polycarbonate, nylon 12 or ceramics.

[0038] It should also be emphasized that in order to achieve the best functional effect of the thumb carpometacarpal joint implant 100, when the material of the lining 132 is a polymer, the surface roughness Ra value of the mortise-and-neither-hole 132a of the lining 132 does not exceed 2 μm. When the material of the lining 132 is ceramic, the surface roughness Ra value of the concave spherical surface 132a1 does not exceed 0.02 μm.

[0039] See also Figure 2 , Figure 4 and Figure 5 In a specific embodiment, the insertion handle 131 is formed with a mounting groove 131a for mounting the liner 132, the side wall of the mounting groove 131a is provided with a recess 1312, and the outer wall of the liner 132 is provided with a convex portion 1322; the convex portion 1322 can be engaged with the recess 1312 to fix the liner 132 relative to the insertion handle 131. This indirectly improves the stability of the connection between the hinge 120 and the matching member 130.

[0040] More specifically, if Figure 4 and Figure 5 As shown, the shape of the liner 132 can be hemispherical, cylindrical, or conical. For the hemispherical liner 132, its convex portion 1322 should be completely in contact with the concave portion 1312 of the handle to prevent the liner 132 from swinging relative to the insertion handle 131. For other shapes, an appropriate gap should be reserved between the outer top of the liner 132 and the installation groove 131a to facilitate the installation of the liner 132 in place.

[0041] Optionally, the outer surface of the lining 132 is provided with one or more convex or concave parts for engagement, and the convex or concave structure is distributed continuously or discontinuously in the circumferential direction, and its specific cross-sectional shape can be an arc, a rectangle, or the like.

[0042] It should also be noted that a protruding structure is generally provided on the outside of the lining 132 to improve the stability of the connection between the lining 132 and the insertion handle 131 .

[0043] Optionally, the side wall of the installation groove 131 a is provided with a convex structure, and the outer wall of the liner 132 is provided with a concave structure; the concave structure can be engaged with the convex structure to fix the liner 132 relative to the insertion handle 131 .

[0044] In an implementable technical solution, in order to facilitate assembly, when a convex portion 1322 or a concave portion is provided on the outside of the lining 132, the convex height or concave depth thereof shall not exceed 0.15 mm.

[0045] Please continue reading Figure 4In a specific embodiment, the pestle-mortise socket 132a is composed of a concave spherical surface 132a1 and an inclined curved surface 132a2 connected to the concave spherical surface 132a1, and the inclined curved surface 132a2 is used to avoid the columnar structure 123 so as to expand the swing range of the hinge 120 relative to the matching component 130.

[0046] It can also be understood that the provision of the inclined curved surface 132a2 can also reduce the wear on the columnar structure 123 and provide guidance when the ball head 122 is installed on the concave spherical surface 132a1.

[0047] See also Figure 1 , Figure 2 and Figure 6 The mating piece 130 includes an inserting handle 131, and the cross section of the inserting handle 131 near the ball head is a triangular surface. It can be understood that the inserting handle 131 with a triangular cross section can enhance the anti-rotation ability of the handle, so as to improve the stability and reliability of the mating piece 130.

[0048] Furthermore, if Figure 2 or Figure 7 As shown, the cross-sectional area of ​​the insertion handle 131 gradually decreases from the proximal end of the ball head 122 to the distal end of the ball head 122 , thereby facilitating the insertion of the insertion handle 131 into the medullary cavity 200 a of the metacarpal bone 200 .

[0049] Optionally, the cross-section of the distal ball head end of the insertion handle 131 is triangular or circular.

[0050] Optionally, the outer shape of the insertion handle 131 is similar to the shape of the medullary cavity 200 a to further improve the stability of the connection between the insertion handle 131 and the metacarpal bone 200 .

[0051] See also Figure 7 In another specific embodiment, a porous biological structure 134 is attached to the outer surface of the insertion handle 131 near the ball head 122 .

[0052] It can be understood that the proximal ball end of the insertion handle 131 is exposed outside the bone marrow cavity 200a of the metacarpal bone 200 or contacts the cross-section of the metacarpal bone 200. The porous biological structure 134 attached to the outer surface of the proximal ball end of the insertion handle 131 can promote postoperative bone cell growth and bone fusion, thereby enhancing the combination of the insertion handle 131 and the surrounding bone tissue, and improving the stability and service life of the prosthesis embedding.

[0053] Optionally, the porous biological structure 134 can be made by spraying or 3D printing process.

[0054] Furthermore, the distal ball end of the insertion handle 131 is surface polished, which can facilitate the installation of the insertion handle 131 into the medullary cavity 200a, reduce friction and damage to bone tissue, and reduce the risk of postoperative complications.

[0055] It should also be noted that if Figure 8 As shown, the proximal end of the inserting handle 131 is provided with a mounting groove 131a, which can be directly connected to the hinge 120 and can also be used to install the liner 132. When installing the liner 132, a limiting structure matching the locking mechanism of the liner 132 is provided in the circumferential direction of the mounting groove 131a. When necessary, the mounting groove 131a should also retain an installation gap with the liner 132 to facilitate the installation of the liner 132.

[0056] The present invention also provides a method for evaluating the performance of a thumb carpometacarpal joint implant 100 as described above, comprising the steps of: S1, resecting the articular surface of the metacarpal bone 200 of multiple human body samples, so that the metacarpal bone 200 has an incision and the medullary cavity 200a of the metacarpal bone 200 is exposed; S2, inserting the matching piece 130 into the bone marrow cavity 200a to complete the fixation of the matching piece 130; S3, cleaning the articular surface of the trapezium 300 to obtain a smooth and clean articular surface; S4, fitting the articular surface 121 of the hinge 120 with the articular surface of the trapezium 300; S5, when the hinge 120 and the trapezium 300 are relatively fixed, the matching piece 130 is matched with the ball head 122 by operating the metacarpal bone 200 to obtain a plurality of human body samples using the thumb carpometacarpal joint implant 100; S6, obtaining physiological evaluation parameters of human body samples using the thumb carpometacarpal joint implant 100, grouping multiple samples into primary groups according to the same type of physiological evaluation parameters, and obtaining a group number of each primary group; S7, collecting medical images of the thumb carpometacarpal joint implant 100 used by each human sample at the same time interval to obtain usage conditions of the thumb carpometacarpal joint implant 100 of each human sample; S8, according to the usage of the thumb carpometacarpal joint implant 100 of each human sample, the human samples are grouped into secondary groups based on the first grouping to obtain a good usage group and an abnormal usage group, and the ratio of the number of people in the good usage group to the number of people in the abnormal usage group under each group number is obtained; S9, obtaining a statistical chart according to the group number of each primary group and the ratio of the number of people in the good use group to the number of people in the abnormal use group under each group number; S10, obtaining physiological evaluation parameters of human body samples with a high proportion of good groups using the thumb carpometacarpal joint implant 100 according to statistical charts; S11, evaluating the performance of the thumb carpometacarpal joint implant 100 according to the characteristics or ranges of the physiological evaluation parameters of the human sample group.

[0057] Furthermore, the physiological evaluation parameters of the human body sample include one or more of gender parameters, age parameters, bone density parameters, and disease grade parameters; Accordingly, each first-level grouping includes one or more of a first group divided according to gender parameters, a second group divided according to age parameters, a third group divided according to bone density parameters, and a fourth group divided according to disease grade parameters; and each of the human samples is divided into first-level groups under different physiological evaluation parameters.

[0058] Optionally, before obtaining the usage of each human sample thumb carpometacarpal joint implant 100, the method further includes the following steps: collecting the range of motion parameters and thumb strength parameters of the thumb of each human sample at the same time interval after using the thumb carpometacarpal joint implant 100; and / or, At the same time interval after using the thumb carpometacarpal joint implant 100, a questionnaire survey is designed to collect the subjective experience of each human sample.

[0059] It can be understood that the performance evaluation method of the thumb carpometacarpal joint implant 100 of the present invention includes any one of the thumb carpometacarpal joint implants 100 described above, and therefore has all the beneficial effects of the thumb carpometacarpal joint implant 100.

[0060] It should also be noted that the performance evaluation method used for the thumb carpometacarpal joint implant 100 by setting multiple types of primary groupings of different physiological evaluation parameters is beneficial for effectively evaluating the applicability of the thumb carpometacarpal joint implant 100 with fewer human samples, thereby obtaining technical advantages over the middle finger carpometacarpal joint prosthesis in the prior art.

[0061] As described above, the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that the technical solutions described in the aforementioned embodiments may still be modified, or some of the technical features thereof may be replaced by equivalents. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A thumb carpometacarpal joint implant, used for installation between the metacarpal bone and trapezium of a human body; characterized in that: Including hinged parts and matching parts; One end of the hinged member is formed with an articular curved surface that abuts against the articular surface of the trapezium, and the other end is formed with a ball head that rotatably cooperates with the matching member; the matching member is used to be inserted into the bone marrow cavity of a cut in the metacarpal bone; The joint curved surface is connected to the ball head via a columnar structure, and a radial dimension of the columnar structure close to the ball head is smaller than a radial dimension of the ball head.

2. The thumb carpometacarpal joint implant according to claim 1, characterized in that: The matching piece comprises an inserting handle and an inner liner, wherein the inner liner is embedded in the inserting handle and is formed with a pestle-and-mortise socket, and the pestle-and-mortise socket is matched with the ball head to form a pestle-and-mortise type joint prosthesis.

3. The thumb carpometacarpal joint implant according to claim 2, characterized in that: The inserting handle is formed with an installation groove for installing the liner, the side wall of the installation groove is provided with a recessed portion, and the outer wall of the liner is provided with a convex portion; the convex portion can be engaged with the recessed portion to fix the liner relative to the inserting handle.

4. The thumb carpometacarpal joint implant according to claim 2, characterized in that: The pestle-mortise socket is respectively composed of a concave spherical surface and an inclined curved surface connected to the concave spherical surface. The inclined curved surface is used to avoid the columnar structure so as to expand the rotation range of the hinge relative to the matching part.

5. The thumb carpometacarpal joint implant according to any one of claims 1 to 4, characterized in that: The matching piece includes an insertion handle, and the cross section of the insertion handle near the ball head end is a triangular surface.

6. The thumb carpometacarpal joint implant according to claim 5, characterized in that: The cross-sectional area of ​​the inserting handle gradually decreases from the proximal ball head end to the distal ball head end.

7. The thumb carpometacarpal joint implant according to claim 6, characterized in that: The outer surface of the proximal ball head end of the insertion handle is attached with a porous biological structure; and the surface of the distal ball head end of the insertion handle is polished.

8. A method for evaluating the performance of a thumb carpometacarpal joint implant according to any one of claims 1 to 7, characterized in that: Includes steps: Resecting the metacarpal articular surface of a plurality of human body samples so that the metacarpal bone has an incision and the medullary cavity of the metacarpal bone is exposed; embedding the matching piece into the medullary cavity to complete the fixation of the matching piece; cleaning the articular surface of the trapezium to obtain a smooth and clean articular surface; The articular curved surface of the hinge is arranged to fit the articular surface of the trapezium; Under the condition that the hinge and the trapezium are relatively fixed, the matching piece is matched with the ball head by operating the metacarpal bone to obtain a plurality of human body samples using the thumb carpometacarpal joint implant; Obtaining physiological evaluation parameters of human body samples using the thumb carpometacarpal joint implant, grouping multiple samples into primary groups according to the same type of physiological evaluation parameters, and obtaining a group number for each primary group; Collect medical images of the thumb carpometacarpal joint implant used by each human sample at the same time interval to obtain the usage of the thumb carpometacarpal joint implant of each human sample; According to the usage of thumb carpometacarpal joint implants of each human sample, the human samples are grouped into secondary groups on the basis of the first grouping to obtain a good usage group and an abnormal usage group, and the ratio of the number of people in the good usage group to the number of people in the abnormal usage group under each group number is obtained; According to the group number of each primary grouping and the ratio of the number of people in the good use group to the number of people in the abnormal use group under each group number, a statistical chart is obtained; According to the statistical chart, the physiological evaluation parameters of the human body samples with a high proportion of good group using the thumb carpometacarpal joint implant are obtained; The performance of the thumb carpometacarpal joint implant is evaluated based on the characteristics or ranges of the physiological evaluation parameters of the human sample group.

9. The method for evaluating performance according to claim 8, characterized in that: The physiological evaluation parameters of the human sample include one or more of a gender parameter, an age parameter, a bone density parameter, and a disease grade parameter; Accordingly, each first-level grouping includes one or more of a first group divided according to gender parameters, a second group divided according to age parameters, a third group divided according to bone density parameters, and a fourth group divided according to disease grade parameters; and each of the human samples is divided into first-level groups under different physiological evaluation parameters.

10. The postoperative performance evaluation method according to claim 9, characterized in that: Before obtaining the use of thumb carpometacarpal joint implants for each human sample, it also included; collecting the range of motion parameters and thumb strength parameters of the thumb of each human sample at the same time interval after using the thumb carpometacarpal joint implant; and / or, At the same time interval after using the thumb carpometacarpal joint implant, a questionnaire survey was designed to collect the subjective experience of each human sample.

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