CN119454298A - Thumb wrist-metacarpal joint implant and method for evaluating usability thereof - Google Patents

Abstract

The present invention discloses a thumb carpometacarpal joint implant and a method for evaluating its performance, which is used to be installed between the human metacarpal bone and the trapezium; it includes a hinge and a matching piece; one end of the hinge is formed with a joint curved surface that abuts and matches with the joint surface of the trapezium, and the other end is formed with a ball head that rotates and matches with the matching piece; the matching piece is used to be inserted into the bone marrow cavity of a cut in the metacarpal bone; and the joint curved 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. The technical solution of the present invention aims to provide a thumb carpometacarpal joint implant that retains the trapezium bone mass to the greatest extent and has a large range of motion.

Description

Thumb wrist-metacarpal joint implant and method for evaluating usability thereof

Technical Field

The invention relates to the field of joint prostheses, in particular to a thumb wrist-palm joint implant and a use performance evaluation method thereof.

Background

In daily life, the thumb wrist-palm joint plays a role of grabbing the palm, and is one of the most common disease sites of primary osteoarthritis, and the prevalence rate of osteoarthritis of men and women is 7% and 15% respectively, which is common in middle-aged women. Pain is one of the common clinical symptoms of osteoarthritis in the carpal and metacarpal joints of the thumb.

Currently, common treatments for advanced thumb carpometacarpal osteoarthritis include thumb carpometacarpal fusion, trapezium resection, thumb carpometacarpal replacement, and the like. The thumb carpometacarpal joint fusion can be used for treating the stages II and III of the thumb carpometacarpal arthritis with good effect, but the thumb movement is limited after operation, the joint melting position is not healed, and the navicular bone enlargement, the trapezium osteoarthritis and the thumb metacarpophalangeal arthritis are easy to occur. The trapezium bone excision is suitable for the stages of Eaton II, III and IV of the metacarpal and the wrist arthritis of the thumb, and has satisfactory short-term curative effect after the trapezium bone excision, but the problems of unstable thumb force, weak strength and the like often exist. The thumb carpometacarpal joint replacement procedure immediately eliminates pain, maintains stability of the first carpometacarpal, increases joint flexibility, and improves strength of the thumb, and has attracted considerable attention. At present, the internationally common thumb wrist-palm joint is provided with a mortar cup on a trapezium bone, the bone removal amount of the prosthesis is more, and the looseness rate of the prosthesis implanted for about 5 years reaches 15%.

Disclosure of Invention

The invention aims to provide a thumb wrist-metacarpal joint implant and a use performance evaluation method thereof, which aim to reduce bone removal amount during prosthesis installation, expand flexibility and movable range of metacarpal joint prostheses and improve use experience.

To achieve the purpose, the invention adopts the following technical scheme:

a thumb wrist-metacarpal joint implant for mounting between a metacarpal bone and a trapezium bone of a human body, comprising a hinge and a mating member;

one end of the hinge piece is provided with a joint curved surface which is in abutting fit with the joint surface of the trapezium, and the other end of the hinge piece is provided with a ball head which is in running fit with the fit piece;

and the joint curved surface is connected with the ball head through a columnar structure, and the radial dimension of the columnar structure, which is close to the ball head, is smaller than the radial dimension of the ball head.

In an embodiment, the mating member includes an insert shank and a liner, the liner is embedded in the insert shank, the liner is formed with a socket, and the socket mates with the ball head to form a socket joint prosthesis.

In one embodiment, the insert handle is provided with a mounting groove for mounting the lining, a concave part is arranged on the side wall of the mounting groove, a convex part is arranged on the outer wall of the lining, and the convex part can be clamped with the concave part so as to fix the lining relative to the insert handle.

In an embodiment, the pestle and socket is respectively composed of a concave spherical surface and an inclined curved surface connected with the concave spherical surface, wherein the inclined curved surface is used for avoiding the columnar structure, so that the rotation range of the hinge piece relative to the matching piece is enlarged.

In one embodiment, the mating member comprises an insert handle, and the cross section of the insert handle near the ball head end is a triangle-like surface.

In one embodiment, the cross-sectional area of the stem tapers from the proximal end to the distal end.

In an embodiment, a porous biological structure is attached to the outer surface of the proximal end of the insertion handle, and the surface of the distal end of the insertion handle is polished.

The invention also provides a method for evaluating the using performance of the thumb wrist-metacarpal joint implant, which comprises the following steps:

cutting the metacarpal bone joint surfaces of a plurality of human body samples, so that the metacarpal bone is provided with an incision, and the marrow cavity of the metacarpal bone is exposed;

embedding the mating member into the bone marrow cavity to complete fixation of the mating member;

removing the articular surface of the trapezium bone to obtain a smooth and clean articular surface;

fitting the joint curved surface of the hinge member with the joint surface of the trapezium;

mating the mating member with the ball head by manipulating the metacarpal bone with the hinge member and the trapezium bone relatively fixed to obtain a plurality of human body samples using the thumb wrist metacarpal joint implant;

obtaining physiological evaluation parameters of human body samples using the thumb wrist-metacarpal joint implant, performing primary grouping on a plurality of samples according to the same type of physiological evaluation parameters, and obtaining a group number of each primary grouping;

Collecting medical images of the thumb wrist-metacarpal joint implant of each human body sample using the same interval time period to obtain the service condition of the thumb wrist-metacarpal joint implant of each human body sample;

according to the use condition of the thumb wrist-palm joint implant of each human body sample, carrying out secondary grouping on the human body samples on the basis of the first grouping to obtain a good use group and an abnormal use group, and obtaining the number ratio value of the good use group to the abnormal use group under the serial numbers of each group;

Obtaining a statistical chart according to the group numbers of each level of grouping and the ratio value of the number of people in the good group and the abnormal group under each group number;

according to the statistical chart, obtaining physiological evaluation parameters of human body samples with high good group proportion of the thumb wrist-palm joint implant;

And evaluating the service performance of the thumb wrist-metacarpal joint implant according to the characteristics or the range of each physiological evaluation parameter of the human body sample group.

In an embodiment, the physiological evaluation parameters of the human body sample include one or more of a gender parameter, an age parameter, a bone density parameter, and a disease grade parameter;

correspondingly, each level group comprises 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 mineral density parameters and a fourth group divided according to disease grade parameters, and each human body sample is divided into each level group under different physiological evaluation parameters.

In one embodiment, prior to obtaining the use of each human sample thumb carpometacarpal joint implant, further comprising;

collecting a thumb range of motion parameter and a thumb strength parameter for each human sample at the same time interval after using the thumb carpometacarpal implant, and/or,

During the same time interval after the use of the thumb carpometacarpal joint implant, a questionnaire was designed to collect the subjective experience of each human sample.

Compared with the prior art, the invention has the following beneficial effects:

According to the technical scheme, the articulated piece comprises the joint curved surface, the columnar structure and the ball head which are sequentially connected, when the wrist and metacarpal joint of the human thumb is replaced, the joint curved surface and the trapezium bones can form a curved surface joint pair similar to the original metacarpal joint, so that the trapezium bones provided with the articulated piece do not need to be cut, and excessive influence on thumb force is avoided. And moreover, the trapezium bone keeps the original joint surface structure, so that the implanted thumb wrist metacarpal joint prosthesis meets the original movement requirement. In a specific technical scheme, when the thumb wrist-palm joint implant is installed in an operation, only the joint part of the metacarpal bone close to the trapezium bone is needed to be cut off, and the marrow cavity of the metacarpal bone is exposed, so that a matching piece rotating with the ball head is installed and fixed in the marrow cavity, and a further pestle-socket type joint pair (namely a spherical revolute pair) is formed relative to the original thumb wrist-palm joint, therefore, the thumb wrist-palm joint implant can only form a prosthesis structure of a pair of joint pairs relatively, and the thumb wrist-palm joint implant in the technical scheme can ensure the flexibility of a finger joint after the prosthesis is implanted.

It should be further noted that, in the technical scheme of this embodiment, saddle face with the bulb passes through columnar structure and connects, columnar structure is close to the radial dimension of bulb is less than the radial dimension of bulb, it can be understood that columnar structure's setting can make the bulb with the cooperation piece forms spherical revolute pair to and make the rotation angle scope of circumference unanimous, thereby improve the stability of thumb wrist palm joint implant activity in human palm portion and human use experience.

Drawings

In order to more clearly illustrate the embodiments of the invention or the technical solutions of the prior art, the drawings which are used in the description of the embodiments or the prior art will be briefly described, it being obvious that the drawings in the description below are only some embodiments of the invention, and that other drawings can be obtained from these drawings without inventive faculty for a person skilled in the art.

The structures, proportions, sizes, etc. shown in the drawings are shown only in connection with the present disclosure, and are not intended to limit the scope of the invention, since any modification, variation in proportions, or adjustment of the size, etc. of the structures, proportions, etc. should be considered as falling within the spirit and scope of the invention, without affecting the effect or achievement of the objective.

FIG. 1 is a schematic view of one embodiment of a thumb wrist-metacarpal joint implant of the present invention;

FIG. 2 is a schematic cross-sectional view of one embodiment of a thumb carpometacarpal implant of the present invention;

FIG. 3 is a schematic view of an embodiment of the hinge of the present invention;

FIGS. 4a and 4b are cross-sectional views of one embodiment of a liner, respectively;

FIGS. 5a and 5b are cross-sectional views of one embodiment of an insert handle;

FIG. 6 is a cross-sectional view of one embodiment of an insert handle of the present invention;

FIG. 7 is a cross-sectional view of yet another embodiment of an insert handle of the present invention;

FIGS. 8a and 8b are cross-sectional views of one embodiment of an insert handle;

Illustration 100, thumb wrist-metacarpal joint implant;

120. the device comprises a hinge part, 121, a joint curved surface, 122, a ball head, 123 and a columnar structure;

130. fitting piece, 131, inserting handle, 131a, mounting groove, 1312, concave part;

132. 132a, a pestle and socket, 132a1, a concave spherical surface, 132a2, an inclined curved surface, 1322, a convex part, 134 and a porous biological structure;

200. Metacarpal bone, 200a, bone marrow cavity, 300, trapezium bone.

Detailed Description

In order to make the technical objects, features and advantages of the present invention more obvious and understandable, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is apparent that the embodiments described below are only some embodiments of the present invention, not all embodiments of the present invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

In the description of the present invention, it should be understood that the directions or positional relationships indicated by the terms "upper", "lower", "top", "bottom", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as limiting the present invention. It is noted that when one component is referred to as being "connected" to another component, it can be directly connected to the other component or intervening components may also be present.

The technical scheme of the invention is further described below by the specific embodiments with reference to the accompanying drawings.

Embodiments of the present invention provide a thumb carpometacarpal joint implant 100.

Referring to fig. 1, 2 and 3, in one embodiment of the present invention, the thumb carpometacarpal implant 100 is configured to be mounted between a metacarpal bone 200 and a trapezium bone 300 of a human body, wherein the thumb carpometacarpal implant 100 comprises a hinge 120 and a mating member 130;

One end of the hinge member 120 is formed with a curved joint surface 121 which is in abutting fit with the joint surface of the trapezium bone 300, and the other end is formed with a ball head 122 which is in running fit with the fit member 130, wherein the fit member 130 is used for being inserted into a bone marrow cavity 200a of a cut of the metacarpal bone 200;

And the curved joint surface 121 is connected with the ball head 122 through a columnar structure 123, and the radial dimension of the columnar structure 123 is smaller than that of the ball head 122.

It can be appreciated that in the technical solution of the present invention, by providing the hinge 120, the hinge 120 includes the joint curved surface 121, the columnar structure 123 and the ball head 122 which are sequentially connected, and when the wrist and metacarpal joint of the thumb of the human body is replaced, the joint curved surface 121 and the trapezium 300 can form a curved surface joint pair similar to the original metacarpal joint, so that the trapezium 300 provided with the hinge 120 does not need osteotomy, thereby avoiding excessive influence on thumb force. And, the trapezium 300 retains its original articular surface structure, thereby making the implanted thumb carpometacarpal joint prosthesis more compatible with its original movement requirements. In a specific technical solution, when the installation of the thumb wrist-metacarpal joint implant 100 according to the technical solution of the present invention is performed in an operation, only the metacarpal bone 200 needs to be resected near the joint portion of the trapezium bone 300 and the marrow cavity 200a of the metacarpal bone 200 is exposed, so that the matching piece 130 rotating with the ball head 122 is installed and fixed in the marrow cavity 200a, thereby forming a further socket-type joint pair (i.e. a spherical revolute pair) relative to the original thumb wrist-metacarpal joint, therefore, the installation of the thumb wrist-metacarpal joint implant 100 can only form a prosthesis structure of a pair of joint pairs relatively, the thumb wrist-metacarpal joint implant 100 according to the technical solution of the present invention can ensure the flexibility of the finger joint after the prosthesis implantation, and expand the movement range of the finger joint.

It should be further noted that, in the technical solution of this embodiment, the curved joint surface 121 is connected with the ball head 122 through the columnar structure 123, 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 arrangement of the columnar structure 123 can enable the ball head 122 and the mating member 130 to form a spherical revolute pair, and enable the circumferential rotation angle range to be consistent, so as to improve the stability of the thumb wrist-palm joint implant 100 moving in the palm of the human body.

It should also be noted that the hinge 120 is generally made of a material with better biocompatibility and better wear resistance, such as polyetheretherketone, polyetheretherketone derivatives, polycarbonate, polyacetal, cobalt-chromium alloy, ceramic, etc.

It should be noted that the 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 the surgical removal to form a curved joint pair. The curved surface 121 may be designed according to the actual condition of the articular surface of the trapezium 300 of the patient. Such as providing the curved surface 121 with a concave shape, a potato-chip shape, a saddle-shape, etc., for fitting the joint surface of the trapezium 300.

Alternatively, in order to save the cost of the operation and to improve the reliability of the joint surface connection of the prosthesis of the joint surface 121 to the trapezium bone, only the shape of the joint surface 121 is set in a saddle-like shape. When the hinge 120 is installed, the joint surface of the trapezium 300 may be properly treated to ensure that the surface thereof is smooth and clean, and no excessive bone chips or soft tissue remains, thereby enabling smooth movement of the prosthesis and the original joint surface of the curved joint surface 121, thereby completing effective engagement with the trapezium 300.

The material of the curved surface 121 has good wear resistance and low friction coefficient, so that the prosthesis is matched with the joint surface of the original trapezium bone, so that the friction to the bone joint can be reduced, and the pain symptom can be relieved. Meanwhile, the invention also provides a pestle-and-socket joint pair consisting of the ball head 122 and the matching piece 130, so that the joint prosthesis can perform smooth multidirectional movement, and the risk of the displacement of the joint curved surface 121 prosthesis is reduced. And the pestle-and-socket joint pair can better simulate the movement range of a natural joint and provide multidirectional movement capability. Has important help to restore normal functions such as thumb grip, pinching and rotation.

It should be further noted that, by using the joint curved surface 121 to mate with the joint surface of the original trapezium 300, an incision is made on the metacarpal 200 to expose the marrow cavity 200a of the metacarpal 200, so that the mating member 130 is fixed to the metacarpal 200, the operation is generally highly repeatable, and the related operation technique is relatively mature, so that the placement of the thumb wrist metacarpal joint implant can also improve the success rate of the operation.

Alternatively, the mating element 130 may be a cup having a concave spherical surface that forms a spherical revolute pair with the ball head 122.

Optionally, the mating member 130 is an insert stem 131, the insert stem 131 has a concave spherical surface forming a spherical revolute pair with the ball head 122, and a length dimension of the insert stem 131 is greater than a length dimension of the hinge member 120. So that the connection between the insertion handle 131 and the marrow cavity 200a of the metacarpal 200 is more secure.

With continued reference to fig. 1 and 2, in one embodiment of the present invention, the mating member 130 includes an insert stem 131 and a liner 132, the liner 132 is embedded in the insert stem 131, the liner 132 is formed with a socket 132a, and the socket 132a mates with the ball head 122 to form a socket joint prosthesis.

It will be appreciated that the provision of the inner liner 132 provides different material options for the components of the thumb carpometacarpal implant 100, facilitating the configuration of different materials for the insert shank 131 and the inner liner 132 to increase the useful life of the thumb carpometacarpal implant 100. For example, to ensure the connection strength between the insert shank 131 and the metacarpal 200, a material having high mechanical strength is generally selected. To reduce wear of the liner 132 and the ball 122, the liner 132 is generally made of a material having high wear resistance.

Optionally, the material of the insert stem 131 is polyetheretherketone and its derivatives, titanium alloy, cobalt chrome alloy or ceramic and other biological materials.

Optionally, the lining 132 is made of ultra-high molecular weight polyethylene (including high cross-linked ultra-high molecular weight polyethylene, ultra-high molecular weight polyethylene containing antioxidant and high cross-linked ultra-high molecular weight polyethylene), polyether ether ketone, polycarbonate, nylon 12 or ceramic, and other wear-resistant biological materials.

It is also emphasized that in order for the thumb carpometacarpal joint implant 100 to exhibit optimal functional effects, the pestle socket 132a surface roughness Ra value of the liner 132 does not exceed 2 μm when the material of the liner 132 is polymeric. 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.

Referring to fig. 2,4 and 5, in a specific embodiment, the insert shank 131 is formed with a mounting groove 131a for mounting the liner 132, a recess 1312 is provided on a side wall of the mounting groove 131a, a protrusion 1322 is provided on an outer wall of the liner 132, and the protrusion 1322 can be engaged with the recess 1312 to fix the liner 132 relative to the insert shank 131. Thereby indirectly improving the stability of the connection of the hinge 120 with the mating member 130.

More specifically, as shown in fig. 4 and 5, the shape of the liner 132 may be hemispherical, columnar, or conical. For a hemispherical shaped liner 132, the protrusions 1322 should fully conform to the configuration of the shank recesses 1312 to prevent the liner 132 from rocking relative to the insert shank 131. For other shapes, a proper gap is reserved between the top of the outer side of the inner liner 132 and the mounting groove 131a, so that the inner liner 132 can be mounted in place.

Optionally, the outer surface of the inner liner 132 is provided with one or more engaging protrusions or recesses, and the protrusions or recesses are continuously distributed or intermittently distributed along the entire circumference, and the specific cross-sectional shape of the inner liner may be arc-shaped, rectangular, or the like.

It should be noted that, a protrusion structure is generally provided on the outer portion of the inner liner 132 to improve the connection stability between the inner liner 132 and the insert stem 131.

Optionally, a convex structure is disposed on a side wall of the mounting groove 131a, and a concave structure is disposed on an outer wall of the liner 132, and the concave structure can be engaged with the convex structure, so that the liner 132 is fixed relative to the insert handle 131.

In a practical embodiment, when the protrusion 1322 or the recess is provided on the outer portion of the inner liner 132, the protrusion height or the recess depth is not more than 0.15mm for easy assembly.

With continued reference to fig. 4, in a specific embodiment, the socket 132a is respectively formed by 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 configured to avoid the columnar structure 123, so as to expand the swing range of the hinge 120 relative to the mating member 130.

It will also be appreciated that the provision of the inclined curved surface 132a2 also reduces wear with the columnar structure 123 and guides the ball 122 as it is mounted to the concave spherical surface 132a 1.

Referring to fig. 1,2 and 6, the mating member 130 includes an insert stem 131, and a cross section of the insert stem 131 near the ball end is a triangle-like surface. It will be appreciated that the triangular-like cross-section of the insert shank 131 enhances the anti-rotation capability of the shank to improve the stability and reliability of the mating element 130.

Further, as shown in fig. 2 or 7, the cross-sectional area of the insertion handle 131 from the proximal end of the ball head 122 to the distal end of the ball head 122 is gradually reduced, thereby facilitating the insertion of the insertion handle 131 into the medullary cavity 200a of the metacarpal 200.

Optionally, the section of the far spherical end of the insert handle 131 is triangle-like or circular.

Optionally, the external structure of the insert pin 131 is similar to the shape of the marrow cavity 200a, so as to further improve the stability of the connection between the insert pin 131 and the metacarpal 200.

Referring to fig. 7, in another embodiment, a porous biological structure 134 is attached to the outer surface of the proximal end of the insertion handle 131 near the ball 122.

It will be appreciated that the proximal end portion of the stem 131 is exposed outside the bone marrow cavity 200a of the metacarpal 200 or in contact with the cut surface of the metacarpal 200, and the attachment of the porous biological structure 134 to the outer surface of the proximal end of the stem 131 can promote the growth of bone cells and bone fusion after surgery, thereby enhancing the combination of the stem 131 and surrounding bone tissue, improving the stability and the service life of the prosthesis insertion.

Alternatively, the porous biological structure 134 may be made by a spray coating or 3D printing process.

Further, the surface polishing treatment is performed on the distal end of the insertion handle 131, so that the insertion handle 131 can be conveniently mounted to the bone marrow cavity 200a, friction and damage to bone tissues are reduced, and the risk of postoperative complications is reduced.

It should be noted that, as shown in fig. 8, the proximal end of the insert stem 131 is provided with a mounting groove 131a, and the mounting groove 131a may be directly connected to the hinge 120 or may be used for mounting the liner 132. When the liner 132 is mounted, a limit structure matching with the engagement mechanism of the liner 132 is provided in the circumferential direction of the mounting groove 131 a. The mounting groove 131a should also maintain a mounting gap with the liner 132 when needed to facilitate the mounting of the liner 132.

The invention also proposes a method for evaluating the performance of a thumb carpometacarpal joint implant 100 comprising any one of the above, comprising the steps of:

s1, cutting off the joint surface of the metacarpal 200 of a plurality of human body samples, so that the metacarpal 200 is provided with an incision and the marrow cavity 200a of the metacarpal 200 is exposed;

s2, embedding the matching piece 130 into the marrow cavity 200a to fix the matching piece 130;

S3, removing the joint surface of the trapezium 300 to obtain a smooth and clean joint surface;

s4, fitting the joint curved surface 121 of the hinge 120 with the joint surface of the trapezium 300;

S5, with the hinge 120 and the trapezium bone 300 relatively fixed, engaging the engaging member 130 with the ball 122 by manipulating the metacarpal bone 200 to obtain a plurality of human body samples using the thumb carpometacarpal joint implant 100;

S6, acquiring physiological evaluation parameters of human body samples using the thumb wrist-palm joint implant 100, performing primary grouping on a plurality of samples according to the same type of physiological evaluation parameters, and acquiring a group number of each primary grouping;

S7, collecting medical images of the thumb wrist-metacarpal joint implant 100 of each human body sample using the same interval time period to obtain the service condition of the thumb wrist-metacarpal joint implant 100 of each human body sample;

S8, carrying out secondary grouping on the human body samples on the basis of the first grouping according to the use condition of the thumb wrist-palm joint implant 100 of each human body sample so as to obtain a good use group and an abnormal use group, and obtaining the number ratio value of the good use group to the abnormal use group under each group number;

s9, obtaining a statistical chart according to the group numbers of the first-level groups and the ratio value of the number of people in the good use group to the number of people in the abnormal use group under the group numbers;

s10, according to a statistical chart, acquiring physiological evaluation parameters of a human body sample with high good group proportion used by the thumb wrist-palm joint implant 100;

S11, evaluating the use performance of the thumb wrist-metacarpal joint implant 100 according to the physiological evaluation parameter characteristics or ranges of the human body sample group.

Further, the physiological evaluation parameters of the human body sample comprise one or more of sex parameters, age parameters, bone density parameters and disease grade parameters;

correspondingly, each level group comprises 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 mineral density parameters and a fourth group divided according to disease grade parameters, and each human body sample is divided into each level group under different physiological evaluation parameters.

Optionally, before the use of the thumb carpometacarpal joint implant 100 for each human sample is obtained, the steps are further included:

At the same time interval after the use of the thumb carpometacarpal joint implant 100, the range of motion parameters and thumb strength parameters of the thumb of each human sample are collected, and/or,

During the same time interval following use of the thumb carpometacarpal joint implant 100, a questionnaire was designed to collect the subjective experience of each human sample.

It will be appreciated that the method of assessing the performance of the thumb carpometacarpal implant 100 of the present invention includes any of the thumb carpometacarpal implants 100 described above, and thus has all of the benefits of the thumb carpometacarpal implant 100.

It should be further noted that the use of the performance evaluation method for the thumb carpometacarpal implant 100 facilitates the effective evaluation of the applicability of the thumb carpometacarpal implant 100 with fewer human samples by providing multiple types of primary groupings of different physiological evaluation parameters, thereby achieving technical advantages over prior art middle finger carpometacarpal prostheses.

While the invention has been described in detail with reference to the foregoing embodiments, it will be understood by those skilled in the art that the foregoing embodiments may be modified or equivalents may be substituted for some of the features thereof, and that the modifications or substitutions do not depart from the spirit and scope of the embodiments of the invention.

Claims (10)

1. The thumb wrist-metacarpal joint implant is used for being installed between the metacarpal bones and the trapezium bones of a human body and is characterized by comprising a hinge piece and a matching piece;

one end of the hinge piece is provided with a joint curved surface which is in abutting fit with the joint surface of the trapezium, and the other end of the hinge piece is provided with a ball head which is in running fit with the fit piece;

and the joint curved surface is connected with the ball head through a columnar structure, and the radial dimension of the columnar structure, which is close to the ball head, is smaller than the radial dimension of the ball head.

2. The thumb carpometacarpal joint implant of claim 1, wherein the mating member includes an insert stem and a liner embedded in the insert stem, the liner formed with a socket that mates with the ball head to form a socket joint prosthesis.

3. The thumb carpometacarpal joint implant of claim 2, wherein the insert handle is formed with a mounting groove for mounting the liner, a recess is provided on a side wall of the mounting groove, a protrusion is provided on an outer wall of the liner, and the protrusion can be engaged with the recess to fix the liner relative to the insert handle.

4. The thumb carpometacarpal joint implant of claim 2, wherein the socket is formed by a concave spherical surface and an inclined curved surface connected to the concave spherical surface, respectively, the inclined curved surface being configured to avoid the columnar structure so as to expand a range of rotation of the hinge member relative to the mating member.

5. The thumb carpometacarpal joint implant of any one of claims 1 to 4 wherein the mating member includes an inset stem having a triangular-like cross-section proximal to the ball end.

6. The thumb carpometacarpal joint implant of claim 5 wherein the insertion handle tapers in cross-sectional area from the proximal to the distal ball end.

7. The implant of claim 6, wherein the outer surface of the proximal end of the stem is attached with a porous biological structure and the surface of the distal end of the stem is polished.

8. A method for evaluating the performance of a thumb carpometacarpal implant including any one of claims 1 to 7, comprising the steps of:

cutting the metacarpal bone joint surfaces of a plurality of human body samples, so that the metacarpal bone is provided with an incision, and the marrow cavity of the metacarpal bone is exposed;

embedding the mating member into the bone marrow cavity to complete fixation of the mating member;

removing the articular surface of the trapezium bone to obtain a smooth and clean articular surface;

fitting the joint curved surface of the hinge member with the joint surface of the trapezium;

mating the mating member with the ball head by manipulating the metacarpal bone with the hinge member and the trapezium bone relatively fixed to obtain a plurality of human body samples using the thumb wrist metacarpal joint implant;

obtaining physiological evaluation parameters of human body samples using the thumb wrist-metacarpal joint implant, performing primary grouping on a plurality of samples according to the same type of physiological evaluation parameters, and obtaining a group number of each primary grouping;

Collecting medical images of the thumb wrist-metacarpal joint implant of each human body sample using the same interval time period to obtain the service condition of the thumb wrist-metacarpal joint implant of each human body sample;

according to the use condition of the thumb wrist-palm joint implant of each human body sample, carrying out secondary grouping on the human body samples on the basis of the first grouping to obtain a good use group and an abnormal use group, and obtaining the number ratio value of the good use group to the abnormal use group under the serial numbers of each group;

Obtaining a statistical chart according to the group numbers of each level of grouping and the ratio value of the number of people in the good group and the abnormal group under each group number;

according to the statistical chart, obtaining physiological evaluation parameters of human body samples with high good group proportion of the thumb wrist-palm joint implant;

And evaluating the service performance of the thumb wrist-metacarpal joint implant according to the characteristics or the range of each physiological evaluation parameter of the human body sample group.

9. The usability assessment method of claim 8, wherein,

The physiological evaluation parameters of the human body sample comprise one or more of sex parameters, age parameters, bone density parameters and disease grade parameters;

correspondingly, each level group comprises 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 mineral density parameters and a fourth group divided according to disease grade parameters, and each human body sample is divided into each level group under different physiological evaluation parameters.

10. The method of claim 9, further comprising, prior to obtaining the use of the thumb carpometacarpal implant for each human sample;

collecting a thumb range of motion parameter and a thumb strength parameter for each human sample at the same time interval after using the thumb carpometacarpal implant, and/or,

During the same time interval after the use of the thumb carpometacarpal joint implant, a questionnaire was designed to collect the subjective experience of each human sample.