A proximal humerus fracture fixation device and its preparation method

Abstract

The present invention relates to a proximal humerus fracture fixation device and a preparation method thereof. The fixation device includes a columnar main body that is larger at the top and smaller at the bottom. Both the upper and lower ends of the columnar main body are arc surfaces. The surface of the columnar main body is provided with dense pores. A threaded hole is provided at the top of the columnar main body, and a locking hole is provided in the middle of the columnar main body. It has the advantages of simple structure, low cost, strong versatility, and good fixation effect. When fixing a proximal humerus fracture, it can effectively avoid phenomena such as fixation failure, reduction loss, re-displacement, delayed bone healing, and nonunion. The preparation method has the advantages of simple process and high yield.

Description

Technical Field

[0001] The present invention relates to a fracture fixation device, and particularly to a fixation device for proximal humeral fractures and a preparation method thereof. Background Art

[0002] According to statistics, proximal humeral fractures account for a relatively high proportion in all fracture cases, especially for elderly female fractures, the proportion of proximal humeral fractures is even higher. At present, the following two methods are usually adopted for the fixation of proximal humeral fractures in this field: one is external fixation with a bone plate, and the other is internal fixation with an intramedullary nail. These two methods can achieve good effects for fractures with better bone quality, but for fractures with poor bone quality such as osteoporosis, especially for patients with 3 - 4 fractures, these two methods are prone to fixation failure, loss of reduction, re - displacement, and a relatively high incidence of delayed union and non - union of bones. Summary of the Invention

[0003] The purpose of the present invention is to provide a fixation device for proximal humeral fractures and a preparation method thereof. The fixation device has the advantages of simple structure, low cost, strong versatility, and good fixation effect, and can effectively avoid the phenomena of fixation failure, loss of reduction, re - displacement, delayed union and non - union of bones; the preparation method has the advantages of simple process, high yield rate, and strong adaptability.

[0004] To solve the above problems existing in the prior art, a fixation device for proximal humeral fractures provided by the present invention includes a columnar main body that is larger at the top and smaller at the bottom. Both the upper and lower ends of the columnar main body are arc - shaped surfaces. The surface of the columnar main body is provided with dense pores. A threaded hole is provided at the top of the columnar main body, and a locking hole is provided in the middle of the columnar main body.

[0005] Further, in a fixation device for proximal humeral fractures of the present invention, the aperture of the pores is 500 - 1000 μm, and the proportion of the pores on the surface of the columnar main body is 60% - 80%.

[0006] Further, in a fixation device for proximal humeral fractures of the present invention, the upper end of the columnar main body is the greater tubercle, the lower end of the columnar main body is the lesser tubercle, and the greater tubercle and the lesser tubercle are smoothly connected through a waist. A ridge is provided on one side of the waist.

[0007] Further, in a fixation device for proximal humeral fractures of the present invention, two locking holes are provided at intervals, and the line connecting the two locking holes forms an angle of 10 - 20 degrees with the vertical direction.

[0008] Furthermore, for a proximal humerus fracture fixation device of the present invention, there are also two locking screws corresponding to the locking holes; during installation and use, the cylindrical main body is inserted into the medullary cavity of the proximal humerus from top to bottom, and the cylindrical main body and the humerus are fixed by the two locking screws.

[0009] Furthermore, for a proximal humerus fracture fixation device of the present invention, the cylindrical main body and the locking screws are both made of titanium alloy material.

[0010] A preparation method for a proximal humerus fracture fixation device of the present invention is characterized by including the following steps:

[0011] First, collect the morphological data of the medullary cavity of the proximal humerus, and establish a three-dimensional model of the cylindrical main body based on the collected morphological data of the medullary cavity;

[0012] Second, according to the three-dimensional model of the cylindrical main body, use titanium alloy material and utilize 3D printing to make a solid of the three-dimensional model to form a blank of the cylindrical main body;

[0013] Third, open a threaded hole at the top of the blank of the cylindrical main body, and open two vertically distributed locking holes in the middle of the blank of the cylindrical main body to form a finished product of the cylindrical main body.

[0014] Furthermore, for a preparation method for a proximal humerus fracture fixation device of the present invention, in the above step one, pores are distributed on the surface of the three-dimensional model of the cylindrical main body, the pore diameter of the pores is 500 - 1000 μm, and the proportion of the pores in the surface of the three-dimensional model of the cylindrical main body is 60% - 80%.

[0015] Furthermore, for a preparation method for a proximal humerus fracture fixation device of the present invention, in the above step one, a ridge is provided on one side of the middle of the three-dimensional model of the cylindrical main body.

[0016] Furthermore, for a preparation method for a proximal humerus fracture fixation device of the present invention, in the above step three, the included angle between the line connecting the two locking holes and the vertical direction is 10 - 20 degrees.

[0017] Compared with the prior art, a proximal humerus fracture fixation device and its preparation method of the present invention have the following advantages: By providing a columnar main body with a larger upper part and a smaller lower part, both the upper and lower ends of the columnar main body adopt arc surfaces. Dense pores are arranged on the surface of the columnar main body, a threaded hole is arranged at the top of the columnar main body, and a locking hole is arranged in the middle of the columnar main body. Thus, a proximal humerus fracture fixation device with simple structure, low cost, strong versatility, and good fixation effect is formed. In practical applications, the columnar main body is inserted into the medullary cavity of the proximal humerus where the fracture occurs from top to bottom through an aiming frame, and a locking nail is used to pass through the locking hole to connect the columnar main body with the humerus, and the fracture fragments are attached to the columnar main body to achieve the purpose of fracture fixation. By making both the upper and lower ends of the columnar main body adopt arc surfaces, the present invention can better adapt to the medullary cavity contour of the proximal humerus, improving the adaptability to the proximal humerus. By arranging dense pores on the surface of the columnar main body, the tightness of the combination of the columnar main body and the humerus can be improved. By arranging a threaded hole at the top of the columnar main body, it is convenient to connect the aiming frame. By arranging a locking hole in the middle of the columnar main body and installing a locking nail, the stable reliability of the connection between the columnar main body and the humerus can be ensured. Compared with the prior art, when using the fixation device provided by the present invention for proximal humerus fracture fixation, the phenomena of fixation failure, reduction loss, re-displacement, delayed bone healing, and nonunion can be effectively avoided, improving the fracture fixation effect and curative effect. The preparation method of the proximal humerus fracture fixation device provided by the present invention has the advantages of simple process, high yield, and strong adaptability.

[0018] The following further elaborates in detail on a proximal humerus fracture fixation device and its preparation method of the present invention in conjunction with the specific embodiments shown in the accompanying drawings. Brief Description of the Drawings

[0019] Figure 1 It is the front view of a proximal humerus fracture fixation device of the present invention;

[0020] Figure 2 It is the top view of a proximal humerus fracture fixation device of the present invention;

[0021] Figure 3 It is the left view of a proximal humerus fracture fixation device of the present invention;

[0022] Figure 4 It is a schematic diagram of the proximal humerus;

[0023] Figure 5 It is a schematic diagram of a proximal humerus fracture;

[0024] Figure 6 It is the usage state diagram of a proximal humerus fracture fixation device of the present invention. Specific Embodiments

[0025] First of all, it should be noted that the orientation terms such as up, down, left, right, front, and back described in the present invention are only for the purpose of understanding according to the attached drawings, and do not limit the technical solution and the scope of protection of the present invention.

[0026] As Figures 1 to 6 shown in the specific embodiment of a proximal humerus fracture fixation device of the present invention, it includes a columnar main body 1 with a larger upper part and a smaller lower part, and both the upper and lower ends of the columnar main body 1 adopt arc surfaces. Dense pores 2 are arranged on the surface of the columnar main body 1, a threaded hole 3 is arranged at the top of the columnar main body 1, and a locking hole 4 is arranged in the middle of the columnar main body 1. Through the above structural settings, a proximal humerus fracture fixation device with simple structure, low cost, strong versatility, and good fixation effect is formed. In practical applications, the columnar main body 1 is inserted into the medullary cavity of the proximal humerus 7 where the fracture occurs from top to bottom through a aiming frame 6, and a locking nail 5 is used to pass through the locking hole 4 to connect the columnar main body 1 with the humerus, and the fracture fragments are attached to the columnar main body 1 to achieve the purpose of fracture fixation. By making both the upper and lower ends of the columnar main body 1 adopt arc surfaces, the present invention can better adapt to the medullary cavity contour of the proximal humerus, improving the adaptability to the proximal humerus. By arranging dense pores 2 on the surface of the columnar main body 1, the tightness of the combination between the columnar main body 1 and the humerus can be improved. By arranging a threaded hole 3 at the top of the columnar main body 1, it is convenient to connect the aiming frame 6. By arranging a locking hole 4 in the middle of the columnar main body 1 and installing a locking nail 5, the stable and reliable connection between the columnar main body 1 and the humerus can be ensured. Compared with the prior art, using the fixation device provided by the present invention for proximal humerus fracture fixation can effectively avoid phenomena such as fixation failure, reduction loss, re-displacement, delayed bone healing, and nonunion, improving the fracture fixation effect and curative effect. It should be noted that, in order to enhance the fusion and affinity with the human bone, the columnar main body 1 and the locking nail 5 of the present invention are usually made of titanium alloy material. Additionally, it should be pointed out that the above-mentioned aiming frame 6 is a commonly used device in the medical field, and its structure and usage method are well-known to those skilled in the art, and will not be elaborated here.

[0027] As a specific embodiment, the present invention usually designs the pore diameter of the pores 2 to be 500 - 1000 μm, and makes the proportion of the pores 2 on the surface of the columnar main body 1 be 60% - 80% to enhance the tightness of the combination between the columnar main body 1 and the humerus. Among them, the upper end of the columnar main body 1 is the greater tubercle 11, the lower end of the columnar main body 1 is the lesser tubercle 12, and the greater tubercle 11 and the lesser tubercle 12 are smoothly connected through a waist 13 to adapt to the shape of the medullary cavity of the proximal humerus.

[0028] As an optimization solution, in this specific embodiment, a ridge 14 is provided on one side of the waist 13 of the cylindrical main body 1, and the periphery of the ridge 14 is smoothly and transitionally connected to the cylindrical main body 1. The provision of the ridge 14 is conducive to the suture and attachment of the rotator cuff and ligaments, enhancing the practicality. At the same time, in this specific embodiment, two locking holes 4 are arranged at intervals, and the connection line between the two locking holes 4 forms an angle of 10 to 20 degrees with the vertical direction. This setting can ensure the state stability of the cylindrical main body 1 in the humeral proximal medullary cavity, enhancing the firm and reliable connection between the two. It should be noted that when two locking holes 4 are provided, two locking nails 5 are also correspondingly provided. During installation and use, the two locking nails 5 are passed through the corresponding locking holes 4.

[0029] Based on the same concept, the present invention also provides a preparation method for a humeral proximal fracture fixation device, which specifically includes the following steps:

[0030] 1. Collect the morphological data of the medullary cavity of the humeral proximal end, and establish a three-dimensional model of the cylindrical main body 1 based on the collected morphological data of the medullary cavity. This method can ensure that the prepared fixation device can better match the contour of the humeral proximal medullary cavity, improving the adaptability of the fixation device to the humeral proximal end.

[0031] 2. According to the three-dimensional model of the cylindrical main body 1, use titanium alloy material and utilize 3D printing to make a solid of the three-dimensional model to form a blank of the cylindrical main body 1. This method can ensure the accuracy of the fixation device.

[0032] 3. Open a threaded hole 3 at the top of the blank of the cylindrical main body 1, and open two vertically distributed locking holes 4 in the middle of the blank of the cylindrical main body 1 to form a finished product of the cylindrical main body 1. The threaded hole 3 can facilitate the connection of the aiming frame 6, improving the convenience of operation, and the locking holes 4 can facilitate the installation of the locking nails 5.

[0033] As a specific embodiment, in the above step 1, pores 2 are distributed on the surface of the established three-dimensional model of the cylindrical main body 1. The pore diameter of the pores 2 is designed to be 500 - 1000 μm, and the pores 2 account for 60% - 80% of the surface of the three-dimensional model of the cylindrical main body 1 to enhance the tightness of the combination of the cylindrical main body 1 and the humerus.

[0034] As a specific embodiment, in the above step 1, a ridge 14 is provided on one side of the middle of the established three-dimensional model of the cylindrical main body 1. The provision of the ridge 14 is conducive to the suture and attachment of the rotator cuff and ligaments. To enhance the firm and reliable connection between the fixation device and the humerus, in the above step 3, the present invention makes the connection line between the two locking holes 4 form an angle of 10 to 20 degrees with the vertical direction.

[0035] The preparation method of the proximal humerus fracture fixation device provided by the present invention has the advantages of simple process, high product yield and strong adaptability. It should be noted that in actual application, the present invention usually collects three groups of medullary cavity shape data of the proximal humerus according to different age groups, and correspondingly prepares fixation devices of three standard models of large, medium and small sizes to apply to most (more than 90%) patients with proximal humerus fractures. For the small number of patients other than this, specific fixation devices can be customized according to specific needs. According to different situations, the proximal humerus fracture fixation device provided by the present invention can also be combined with a locking plate for combined application to fix special types of fractures.

[0036] The above embodiments only describe the preferred embodiments of the present invention, and do not limit the scope of protection requested by the present invention. Without departing from the design concept of the present invention, various deformations made by those skilled in the art based on the technical solution of the present invention should fall within the protection scope determined by the claims of the present invention.

Claims

1. A proximal humerus fracture fixation device, characterized in that, it includes a columnar main body (1) with a larger upper part and a smaller lower part. Both the upper and lower ends of the columnar main body (1) are arc surfaces. The surface of the columnar main body (1) is provided with densely distributed pores (2). A threaded hole (3) is provided at the top of the columnar main body (1), and a locking hole (4) is provided in the middle of the columnar main body (1); the pore diameter of the pores (2) is 500 - 1000 μm, and the proportion of the pores (2) on the surface of the columnar main body (1) is 60% - 80%; the upper end of the columnar main body (1) is the greater tubercle (11), the lower end of the columnar main body (1) is the lesser tubercle (12), and the greater tubercle (11) and the lesser tubercle (12) are smoothly connected through a waist (13). A ridge (14) is provided on one side of the waist (13); two locking holes (4) are provided at intervals, and the connection line between the two locking holes (4) forms an angle of 10 - 20 degrees with the vertical direction.

2. A proximal humerus fracture fixation device according to claim 1, characterized in that, it further includes two locking screws (5) corresponding to the locking holes (4); during installation and use, the columnar main body (1) is inserted into the medullary cavity of the proximal humerus from top to bottom, and the columnar main body (1) and the humerus are fixed by two locking screws (5).

3. A proximal humerus fracture fixation device according to claim 2, characterized in that, both the columnar main body (1) and the locking screws (5) are made of titanium alloy material.

4. A preparation method of the proximal humerus fracture fixation device according to claim 1, characterized in that, it includes the following steps: First, collect the morphological data of the medullary cavity of the proximal humerus, and establish a three-dimensional model of the columnar main body (1) based on the collected medullary cavity morphological data; Second, according to the three-dimensional model of the columnar main body (1), use titanium alloy material and utilize 3D printing to make a solid of the three-dimensional model to form an embryo of the columnar main body (1); Third, open a threaded hole (3) at the top of the embryo of the columnar main body (1), and open two vertically distributed locking holes (4) in the middle of the embryo of the columnar main body (1) to form a finished product of the columnar main body (1).

5. A preparation method of the proximal humerus fracture fixation device according to claim 4, characterized in that, in the above step one, the surface of the three-dimensional model of the columnar main body (1) is distributed with pores (2), the pore diameter of the pores (2) is 500 - 1000 μm, and the proportion of the pores (2) on the surface of the three-dimensional model of the columnar main body (1) is 60% - 80%.

6. A preparation method of the proximal humerus fracture fixation device according to claim 4, characterized in that, in the above step one, a ridge (14) is provided on one side in the middle of the three-dimensional model of the columnar main body (1).

7. A preparation method of the proximal humerus fracture fixation device according to claim 4, characterized in that, in the above step three, the angle between the connection line of the two locking holes (4) and the vertical direction is 10 - 20 degrees.

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