CN116196154A - Metal shoulder joint prosthesis with porous layer structure and preparation method thereof - Google Patents

Abstract

The invention provides a metal shoulder joint prosthesis with a porous layer structure and a preparation method thereof, the metal shoulder joint prosthesis comprises a shoulder joint humerus handle, a humerus ball head, a ball head outer cup and a gasket, wherein the shoulder joint humerus handle is fixed at the proximal end of a humerus, the humerus ball head is arranged on the shoulder joint humerus handle, the ball head outer cup and the gasket are mutually matched to fix the humerus ball head in the ball head outer cup, the humerus ball head is in rotary contact with the gasket, the gasket comprises a gasket I and a gasket II, the gasket I arranged at the upper end is in press fit with the gasket II arranged at the lower end in the ball head outer cup, and a locking groove is arranged on the ball head outer cup and is matched and locked and fixed with a locking ring arranged on the gasket II. The invention mainly utilizes the 3D printing technology to realize a porous structure on the metal shoulder joint humerus handle, and prevents the humerus handle from sinking during suturing through the design of the screw locking structure and the prosthesis back and side holes, thereby realizing the effect of stable fixation from short term to long term.

Description

Metal shoulder joint prosthesis with porous layer structure and preparation method thereof

Technical Field

The invention relates to the technical field of artificial joint prosthesis preparation, in particular to a metal shoulder joint prosthesis with a porous layer structure and a preparation method thereof.

Background

The shoulder joint is a ball-and-socket joint, with the ball portion consisting of the proximal humeral head of the humerus and the socket portion consisting of the glenoid of the concave scapula. The humeral head (ball) cooperates with the glenoid (socket) to form a shoulder joint that allows movement of the person. The shoulder joint is composed of articular cartilage, tendons, ligaments, joint capsules and muscles around the shoulder joint to provide support and stabilization and allow the shoulder joint to freely move. The mobility of the shoulder joint depends on the proper joint relationship between the humeral head and the glenoid. In recent years, diseases such as shoulder rheumatoid arthritis, osteoarthritis, ischemic necrosis, fracture of the shoulder and the like are one of the more common stubborn diseases of orthopaedics, and the artificial shoulder joint replacement is very important for the cases that the rotator cuff is out of function or the rotator cuff is lack of a bone dead center, and the rotator cuff injury is accompanied with the osteoarthritis, the late rheumatoid arthritis and the like.

With technological advances and rapid developments in medical device technology, such as the invention of patent (CN 202011624476.4), a straight humeral prosthesis is disclosed, comprising a humeral head cap, comprising a spherical outer wall surface and an inner wall surface located within the spherical outer wall surface, the inner wall surface comprising a top wall and an annular sidewall connected to the top wall; an intramedullary post connected with the humeral head cap, the top of the intramedullary post being located within the humeral head cap; wherein, be equipped with conical surface cooperation structure between annular lateral wall and the intramedullary post, humerus bone cap body and intramedullary post pass through conical surface cooperation structure and connect. The scheme effectively solves the problem that the artificial shoulder joint prosthesis with the handle is easy to cause injury to patients during treatment in the related technology. And as another invention patent%

CN20201184551. X) provides a connection structure of a porous structure with an accommodating space and a substrate, a manufacturing method thereof and a prosthesis, wherein the porous structure and an intermediate are connected in advance or integrally formed to obtain a composite body, and the composite body is connected with the substrate, so that the porous structure can be covered on the surface of the substrate. The porous structure is effectively combined with the substrate, the connection requirement of the mechanical structure when the whole and surface properties are different is met, and the problem that the mechanical properties of the substrate are greatly reduced due to a hot pressing process and the like is avoided.

In clinical practice, the existing shoulder joint prosthesis often has the problems of continuous pain, limited joint movement, loose prosthesis, sinking and the like after operation, and along with the progress of 3D printing technology, the personalized customization and rapid molding of the artificial shoulder joint prosthesis are realized. According to the requirement, the 3D printing metal shoulder joint prosthesis can be provided with a porous structure on the surface to form an active surface for promoting bone growth, and meanwhile, the metal shoulder joint prosthesis with personalized design can be prepared according to the requirements of different biological activities and bearing forces of the proximal end and the distal end of the metal shoulder joint femoral stem, so that the design of a new structural prosthesis with biological characteristics capable of increasing the joint mobility, preventing loosening and sinking and reducing postoperative pain of a patient is imperative.

Disclosure of Invention

According to the technical problems that the existing shoulder joint prosthesis is continuously painful, limited in joint movement, loose and sinking, and the like, the metal shoulder joint prosthesis with the porous layer structure and the preparation method thereof are provided. According to the invention, the 3D printing technology is mainly used for realizing the individual design of the porous layer on the surface of the humerus handle part of the shoulder joint prosthesis, the handle body is provided with the screw holes, and the back and the side parts of the neck are provided with holes for fixing, so that the shoulder joint prosthesis which is integrally and precisely prepared and has higher stability is realized, thereby the joint mobility, the looseness resistance and the subsidence are increased, and the postoperative pain of a patient is reduced.

The invention adopts the following technical means:

the utility model provides a metal shoulder joint prosthesis with porous layer structure, includes shoulder joint humerus handle, humerus bulb, bulb outer cup and liner, its characterized in that: the shoulder joint humerus handle is fixed at the proximal end of the humerus, the humerus ball head is mounted on the shoulder joint humerus handle, the humerus ball head is fixed in the ball head outer cup by means of mutual cooperation between the ball head outer cup and the gasket, the humerus ball head is in rotary contact with the gasket, the gasket comprises a gasket I and a gasket II, the gasket I arranged at the upper end is in press fit with the gasket II arranged at the lower end in the ball head outer cup, and a locking groove is formed in the ball head outer cup and is in locking fixation by means of cooperation of a locking ring arranged on the gasket II.

Further, the shoulder joint humerus handle comprises a humerus handle neck and a humerus handle body, and the contact surfaces of the shoulder joint humerus handle and the humerus of the host are porous structures which are approximately communicated in a human bone trabecular shape in three dimensions.

Further, the humerus handle body is provided with a humerus handle locking hole, and the humerus handle neck is provided with a humerus handle back and a side hole for suturing muscles to strengthen fixation and prevent the humerus handle from sinking. The design position of the locking hole is determined according to the position of the prosthesis in the humerus.

The joint humerus handle is provided with a screw hole locking structure, the back of the metal joint humerus handle is provided with three nail hole designs, muscles can be sewed to strengthen fixation, the side faces of the metal joint humerus handle are respectively provided with three nail hole designs, and the three nail hole designs of the joint humerus handle can sew the muscles and prevent the humerus handle from sinking.

Further, the gasket is made of high-crosslinking polyethylene; the humerus bulb is made of alumina ceramic or medical metal material.

Further, the surface of the humerus handle is provided with a pore layer, wherein the porosity of the pore layer of the humerus handle body is 50-90%, the pore diameter of the pore layer is 200-1500 mu m, the thickness of the pore layer is 0.25-4.5mm, and the rest part is of a solid structure and is used for providing enough mechanical support.

Further, the total length of the shoulder humerus stem is 100-150mm, and the stem head and stem body angle of the shoulder humerus stem is 135 degrees.

The invention also discloses a preparation method of the metal shoulder joint prosthesis with the porous layer structure, wherein the shoulder joint humerus handle and the ball head outer cup are prepared by adopting a 3D printing technology in an integrated mode.

Further, the 3D printing technology integrally-formed preparation includes the following steps:

s1, performing tomographic scanning on a target shoulder joint by using a CT scanner, and importing the obtained scanning data into reverse engineering software to obtain a bone defect model of humerus, humerus head, scapula and glenoid of the target shoulder joint;

s2, establishing an initial model of the target shoulder joint prosthesis component according to the humerus and humerus head of the target shoulder joint and the defect models of the scapula and the glenoid, and optimizing the initial model of the target shoulder joint prosthesis component once according to the pore layer structure of the humerus handle of the shoulder joint and the structure of the ball head outer cup;

s3, importing the primary optimization model of the prosthetic component of the target shoulder joint into topology optimization software, and performing topology optimization on the primary optimization model of the prosthetic component of the target shoulder joint according to data acquired by clinical samples as a preset load to obtain a topology optimization model of the prosthetic component of the target shoulder joint;

s4, adopting a 3D printer to respectively and integrally mold and prepare the humerus handle and the bulb shell of the topological optimization target shoulder joint.

Compared with the prior art, the invention has the following advantages:

1. the invention mainly utilizes 3D printing technology to realize porous structure on the metal shoulder joint humerus handle, and has screw locking structure, the prosthesis back and side hole can suture muscle and prevent the humerus handle sinking in a short time, along with the rehabilitation of patients, bone and porous structure are gradually grown into a whole, thus realizing the effect of stable fixation from short term to long term, the humerus ball head is fixed with the ball head outer cup through the pad, and the sliding contact between the humerus ball head and the pad ensures that the shoulder joint can realize multi-angle movement form.

2. The contact surfaces of the 3D printing metal shoulder joint prosthesis and the host bone tissue are porous structures, so that the growth of the new bone tissue is facilitated, meanwhile, the 3D printing technology is integrated into one piece to prepare the 3D printing metal shoulder joint prosthesis with high stability, and the prosthetic loosening or immune rejection reaction caused by coating spalling is avoided.

3. The shoulder joint humerus stem adopts a bone-like trabecular three-dimensional porous structure to promote bone ingrowth and new bone formation, prevents prosthesis sinking at the initial stage of implantation, has larger pore diameter and higher porosity, thereby improving the stability after implantation, has a solid structure inside, and ensures the mechanical support required after the implantation of the prosthesis.

For the reasons, the invention can be widely popularized in the field of artificial shoulder joint prosthesis preparation.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings may be obtained according to the drawings without inventive effort to a person skilled in the art.

FIG. 1 is a schematic view showing an exploded structure of a metal shoulder joint prosthesis having a porous layer structure according to the present invention.

Fig. 2 is a schematic view of the structure of a humeral stem component of a metal shoulder prosthesis having a porous layer structure according to the present invention.

Fig. 3 is a top view of the humeral stem of the shoulder joint of the present invention, in which the design of the side three nail holes can be seen.

Fig. 4 is a partial side view of the shoulder humeral stem of the present invention, with the three nail hole back design seen.

FIG. 5 is a schematic view of the structure of a ball-end cup of a metal shoulder prosthesis with a porous layer structure according to the present invention.

Fig. 6 is a schematic view of a spacer i of a metal shoulder prosthesis having a porous layer structure according to the present invention.

FIG. 7 is a schematic view of a metal shoulder joint prosthesis pad II having a porous layer structure according to the present invention.

Fig. 8 is a side view of the humeral stem of the shoulder joint of the present invention, with angle α of 135 °.

In the figure: 10. an outer cup of the ball head; 11. a locking groove; 20. a gasket I; 30. a gasket II; 31. a locking ring; 32. a clamping hole; 40. humeral head; 50. shoulder joint humerus stem; 51. a humeral stem neck; 52. humerus stem; 53. a humeral stem locking hole; 54. a humeral stem dorsum and a side hole; 541. three nail holes on the side surface; 542. three nail holes on the back.

Detailed Description

It should be noted that, without conflict, the embodiments of the present invention and features of the embodiments may be combined with each other. The invention will be described in detail below with reference to the drawings in connection with embodiments.

For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention, and it is apparent that the described embodiments are only some embodiments of the present invention, not all embodiments. The following description of at least one exemplary embodiment is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses. 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.

It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of exemplary embodiments according to the present invention. As used herein, the singular is also intended to include the plural unless the context clearly indicates otherwise, and furthermore, it is to be understood that the terms "comprises" and/or "comprising" when used in this specification are taken to specify the presence of stated features, steps, operations, devices, components, and/or combinations thereof.

The relative arrangement of the components and steps, numerical expressions and numerical values set forth in these embodiments do not limit the scope of the present invention unless it is specifically stated otherwise. Meanwhile, it should be clear that the dimensions of the respective parts shown in the drawings are not drawn in actual scale for convenience of description. Techniques, methods, and apparatus known to those of ordinary skill in the relevant art may not be discussed in detail, but are intended to be part of the specification where appropriate. In all examples shown and discussed herein, any specific values should be construed as merely illustrative, and not a limitation. Thus, other examples of the exemplary embodiments may have different values. It should be noted that: like reference numerals and letters denote like items in the following figures, and thus once an item is defined in one figure, no further discussion thereof is necessary in subsequent figures.

In the description of the present invention, it should be understood that the azimuth or positional relationships indicated by the azimuth terms such as "front, rear, upper, lower, left, right", "lateral, vertical, horizontal", and "top, bottom", etc., are generally based on the azimuth or positional relationships shown in the drawings, merely to facilitate description of the present invention and simplify the description, and these azimuth terms do not indicate and imply that the apparatus or elements referred to must have a specific azimuth or be constructed and operated in a specific azimuth, and thus should not be construed as limiting the scope of protection of the present invention: the orientation word "inner and outer" refers to inner and outer relative to the contour of the respective component itself.

Spatially relative terms, such as "above … …," "above … …," "upper surface at … …," "above," and the like, may be used herein for ease of description to describe one device or feature's spatial location relative to another device or feature as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "above" or "over" other devices or structures would then be oriented "below" or "beneath" the other devices or structures. Thus, the exemplary term "above … …" may include both orientations of "above … …" and "below … …". The device may also be positioned in other different ways (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

In addition, the terms "first", "second", etc. are used to define the components, and are only for convenience of distinguishing the corresponding components, and the terms have no special meaning unless otherwise stated, and therefore should not be construed as limiting the scope of the present invention.

As shown in FIG. 1, the present invention provides a 3D printed metal shoulder prosthesis comprising a ball-end outer cup 10, a liner I20 (as shown in FIG. 6), a liner II 30, a humeral ball 40 and a shoulder humeral stem 50. The shoulder humeral stem 50 (shown in fig. 2) includes a humeral stem neck 51 and a humeral stem body 52. The upper end of the neck 51 of the humerus handle is sleeved with a humerus ball head 40, and is matched with a liner I20 and a liner II 30, and the liner I20 and the liner II 30 are sleeved with a ball head outer cup 10.

As shown in fig. 5, the inner edge portion of the ball cup 10 is provided with a locking groove 11, and as shown in fig. 7, a liner ii 30 is provided, which includes a clamping hole 32 provided on the upper surface and a locking ring 31 provided on the lower edge, the liner i 20 provided on the upper end and the liner ii 30 provided on the lower end are press-fitted inside the ball cup 10, and the ball cup 10 is provided with the locking groove 11 and the locking ring 31 provided on the liner ii 30 to be locked and fixed in a matching manner. Namely, the ball head outer cup 10 and the pad are matched with each other to fix the humerus ball head 40 in the ball head outer cup 10, and the humerus ball head is in rotary contact with the pad.

In the present invention, the shoulder joint humeral stem prosthesis and the host bone tissue interface are each provided as a porous structure, specifically the humeral stem shaft 52. The shoulder humerus handle 50 and the ball head outer cup 10 are manufactured by integrally forming with 3D printing technology. The surface of the humerus handle provided by the embodiment has a porous structure which is similar to the three-dimensional communication of the trabecula of the human body, and is beneficial to the ingrowth of new bone tissues of the human body.

The materials of the ball head outer cup 10 and the joint humerus handle 50 are tantalum, tantalum alloy or other medical metal materials, the gasket I20 and the gasket II 30 can be alumina ceramics, polyethylene or metal materials, and the materials of the humerus ball head 40 are alumina ceramics or medical metal materials. In the embodiment of the present invention, the liner I20 and the liner II 30 are high crosslinked polyethylene, the humeral head 40 is alumina ceramic, and the materials of the head outer cup 10 and the articular humeral stem 50 are tantalum and tantalum alloy. Tantalum is a well-known "bio-philic" metal, has very stable chemical properties in a body fluid environment, has very strong corrosion resistance, and has excellent biocompatibility; but the density and elastic modulus of tantalum are very high, reducing the comfort of postoperative patient activity. In the embodiment of the invention, the contact surface of the shoulder joint humerus stem prosthesis and the host bone tissue is made of porous tantalum material, so that the shoulder joint humerus stem prosthesis can be well integrated with the bone tissue, has long-term stability, can prevent the stress shielding phenomenon of an implantation position, and can avoid osteoporosis and even secondary fracture.

As shown in fig. 3 and 4, the humeral stem 52 is provided with a humeral stem locking hole 53, the humeral stem neck 51 is provided with a humeral stem back and side holes 54, the articular humeral stem is provided with a screw hole locking structure, the metal articular humeral stem back is provided with a three-nail hole design 542, muscles can be sutured to strengthen fixation, and the sides are respectively provided with a three-nail hole design 541 (the hatched portion in fig. 3 is a portion of the porous structure in this view), and muscles can be sutured and sinking of the humerus stem is prevented.

In the embodiment of the invention, the surfaces of the proximal end and the distal end of the humerus handle are provided with pore layers, wherein the porosity of the pore layers of the humerus handle body is 50-90%, the pore diameter of the pore layers is 200-1500 mu m, the thickness of the pore layers is 0.25-4.5mm, and the rest is a solid structure for providing enough mechanical support.

As shown in fig. 8, the total length of the humerus handle of the joint provided in this embodiment is 100-150mm, and the angle between the handle head and the handle body of the humerus handle of the shoulder joint is 135 °.

In order to further improve the lubrication degree of the contact surface of the outer cup of the artificial ball head and the ball head of the humerus, the friction and abrasion are reduced, and the outer cup of the 3D printing metal ball head is subjected to post-treatment, including but not limited to mechanical methods or laser surface treatment and the like. In this embodiment, mechanical grinding and polishing are used to process the inner and outer surfaces of the 3D printing metal ball head outer cup 10, so that the surfaces thereof have good wear resistance.

In the embodiment of the invention, the shoulder joint humerus handle with the porous layer structure and the ball head outer cup are integrally formed by adopting a 3D printing technology.

The 3D printing technology integrated forming preparation method comprises the following steps: firstly, performing fault scanning on a target shoulder joint by using a Micro-CT scanner, importing the obtained scanning data into reverse engineering software such as Mimics, and then separating soft tissues and bones in the software by using contrast difference to obtain a humerus defect model of the target shoulder joint. And establishing an initial model of the target shoulder joint prosthesis component according to the humerus defect model of the target shoulder joint. The initial model of the target shoulder prosthesis component of the embodiment is optimized once according to preset parameters of the porous structure (e.g., humeral stem 52, aperture, thickness of the porous layer, etc., as described above).

The primary optimization model of the target shoulder prosthesis component is imported into topology optimization software, such as Abaqus. According to the data acquired by the clinical sample as the preset load, in the embodiment, the preset load value is set to be half of the weight of the target patient, and the primary optimization model of the target shoulder joint prosthesis component is subjected to topological optimization to obtain the topological optimization model of the target shoulder joint prosthesis component.

And (3) introducing the topological optimization model of the target shoulder joint prosthesis part into a 3D printer, performing selective laser melting manufacturing, and respectively performing integrated molding preparation on the humerus handle 50 and the bulb outer cup 10 of the topological optimization target shoulder joint. According to the high melting point (2980 ℃) and high density (16.68 g/cm) of tantalum metal ³ ) Characterized in that the 3D printing process parameters adopt a high laser power and high porosity design, the 3D printing laser power provided by the embodiment is 150-350W, and the porosity of the porous humerus handle layer is 50-90%. The present embodiment allows for the personalized design of different pore sizes and porous layer thicknesses on the same prosthetic component. The joint prosthesis and the host bone tissue contact surface provided by the embodiment are of three-dimensional porous structures, so that the bone ingrowth capacity is improved, and meanwhile, the joint prosthesis has enough bearing effect on the shoulder humerus stem and good tribological performance of the ball head outer cup. The integrated preparation of the 3D printing metal shoulder joint prosthesis has higher stability, and effectively slows down implantation of the porous layer prepared by a surface treatment methodAnd the abrasion scraps generated in the later stage fall off, the prosthesis loosens and the like.

Finally, it should be noted that: the above embodiments are only for illustrating the technical solution of the present invention, and not for limiting the same; although the invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some or all of the technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit of the invention.

Claims (8)

1. The utility model provides a metal shoulder joint prosthesis with porous layer structure, includes shoulder joint humerus handle, humerus bulb, bulb outer cup and liner, its characterized in that: the shoulder joint humerus handle is fixed at the proximal end of the humerus, the humerus ball head is mounted on the shoulder joint humerus handle, the humerus ball head is fixed in the ball head outer cup by means of mutual cooperation between the ball head outer cup and the gasket, the humerus ball head is in rotary contact with the gasket, the gasket comprises a gasket I and a gasket II, the gasket I arranged at the upper end is in press fit with the gasket II arranged at the lower end in the ball head outer cup, and a locking groove is formed in the ball head outer cup and is in locking fixation by means of cooperation of a locking ring arranged on the gasket II.

2. The metal shoulder joint prosthesis of claim 1 wherein the shoulder humerus stem comprises a humerus stem neck and a humerus stem body, the contact surfaces of the shoulder humerus stem and the host humerus being porous structures having approximately human bone trabecular-like three-dimensional communication.

3. A metal shoulder joint prosthesis with a porous layer structure according to claim 2, characterized in that the humeral stem body is provided with a humeral stem locking hole, the humeral stem neck is provided with a humeral stem back, side holes for suturing muscles to strengthen fixation and prevent humeral stem sinking.

4. The metal shoulder joint prosthesis with porous layer structure according to claim 1, wherein the material of the liner is highly crosslinked polyethylene; the humerus bulb is made of alumina ceramic or medical metal material.

5. The metal shoulder joint prosthesis with porous layer structure according to claim 2, wherein the humeral stem surface is provided with a porous layer, wherein the humeral stem porous layer has a porosity of 50-90%, a pore diameter of 200-1500 μm, a pore layer thickness of 0.25-4.5mm, and the remainder is a solid structure for providing sufficient mechanical support.

6. The metal shoulder joint prosthesis with porous layer structure according to claim 1, characterized in that the total length of the shoulder humeral stem is 100-150mm.

7. A method for preparing a metal shoulder joint prosthesis with a porous layer structure according to any one of claims 1-6, wherein the shoulder humerus stem and the ball head outer cup are prepared by integrally forming by using a 3D printing technology.

8. The method for preparing a metal shoulder joint prosthesis having a porous layer structure according to claim 7, wherein the 3D printing technique integrally-molded preparation comprises the steps of:

s1, performing tomographic scanning on a target shoulder joint by using a CT scanner, and importing the obtained scanning data into reverse engineering software to obtain a bone defect model of humerus, humerus head, scapula and glenoid of the target shoulder joint;

s2, establishing an initial model of the target shoulder joint prosthesis component according to the humerus and humerus head of the target shoulder joint and the defect models of the scapula and the glenoid, and optimizing the initial model of the target shoulder joint prosthesis component once according to the pore layer structure of the humerus handle of the shoulder joint and the structure of the ball head outer cup;

s3, importing the primary optimization model of the prosthetic component of the target shoulder joint into topology optimization software, and performing topology optimization on the primary optimization model of the prosthetic component of the target shoulder joint according to data acquired by clinical samples as a preset load to obtain a topology optimization model of the prosthetic component of the target shoulder joint;

s4, adopting a 3D printer to respectively and integrally mold and prepare the humerus handle and the ball head outer cup of the topological optimization target shoulder joint.

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