Clavicular intramedullary nail fixation device

Abstract

The application relates to the technical field of medical devices, and discloses a clavicle intramedullary nail fixing device which comprises a clavicle fixing assembly, a sighting device and a holder, the clavicle fixing assembly is connected with the sighting device through the holder, the clavicle fixing assembly comprises an intramedullary nail and a transverse locking nail, the extension direction of the sighting device is the same as that of at least part of the intramedullary nail, the intramedullary nail is provided with a mounting hole, the sighting device is provided with a guide hole, the guide hole and the mounting hole are arranged in a position-keeping mode, so that the transverse locking nail can pass through the guide hole and then be arranged in the mounting hole to be fixedly connected with the clavicle. The intramedullary nail can be fixed in the axial direction of the medullary cavity of the clavicle, conforms to the biomechanical principle, does not damage the periosteum and local blood circulation, and is beneficial to early healing of the fracture. Meanwhile, the guide hole and the mounting hole are arranged in the position-keeping mode, so that the transverse locking nail can be accurately arranged in the mounting hole, the clavicle is fixed and positioned, and the problems of clavicle fracture fixation and positioning are solved.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a locking intramedullary nail fixation device. Background Technology

[0002] Clavicle fractures are common in adults, with 80%-85% being clavicle shaft fractures, and most are unstable fractures. This is because the clavicle is an anatomically an "S"-shaped, slender bone, connecting the upper limb and trunk at both ends through the sternoclavicular and acromioclavicular joints. The midshaft of the clavicle is superficial, with relatively few surrounding soft tissue attachments, a thinner average cortical bone thickness, and a smaller cross-sectional area, making it more prone to stress concentration and fracture under direct or indirect trauma. For most midshaft clavicle fractures, surgical treatment is currently the primary approach, mainly using plate fixation and intramedullary fixation. Plate fixation remains the classic surgical method in clinical practice, quickly stabilizing the fracture and enabling early functional exercises of the affected limb. While plate fixation is the gold standard for clavicle fracture surgery, it has disadvantages such as significant surgical trauma and disruption of local blood supply, increasing the risk of postoperative infection or nonunion. Literature reports a nonunion rate of 1.4%-6.3%. Compared to plate fixation, intramedullary fixation offers advantages such as smaller incisions, less intraoperative bleeding, and better postoperative appearance. Intramedullary nails provide axial fixation along the medullary canal of the clavicle, which is more biomechanically sound. Furthermore, intramedullary fixation does not damage the periosteum or local blood supply. Postoperatively, micromovements at the fracture ends during active movement or partial weight-bearing create stress stimulation, promoting early fracture healing. In addition, intramedullary nails are easy to remove, and there are no extensive screw tracks left after removing plate fixation. Biomechanical studies have shown that the refracture rate with intramedullary fixation is lower than with plate fixation.

[0003] The main disadvantages of intramedullary fixation are its inability to provide rigid fixation, its susceptibility to loosening and displacement, and its limitations compared to extramedullary plate fixation in terms of fracture end compression and locking reliability. It also exhibits relatively poor mechanical strength and anti-rotation capabilities, potentially leading to poor control over clavicle length and rotation. The earliest intramedullary fixation device used was the elastic titanium pin. Due to its elastic recovery, it was easier to insert into the "S"-shaped medullary canal of the clavicle. Simultaneously, the deformation and rebound force created three support points within the medullary canal, converting into pressure and thrust on the fracture ends, thereby achieving reduction and relative stability. However, elastic titanium pins carry the risk of displacement and slippage, especially in cases of comminuted fractures of the midshaft of the clavicle (types B and C in the OTA classification), where they cannot effectively control clavicle length and rotation at both fracture ends.

[0004] Therefore, there is an urgent need for a device for fixation and positioning of clavicle fractures. Summary of the Invention

[0005] In view of the above-mentioned problems in the prior art, the purpose of this application is to provide a novel intramedullary nail fixation device.

[0006] To address the aforementioned problems, this application provides a clavicle intramedullary nail fixation device, comprising a clavicle fixation component, an aiming device, and a holder. The clavicle fixation component is connected to the aiming device via the holder. The clavicle fixation component includes an intramedullary nail and a transverse locking nail. The aiming device extends in the same direction as at least a portion of the intramedullary nail. The intramedullary nail has a mounting hole, and the aiming device has a guide hole. The guide hole and the mounting hole are aligned so that the transverse locking nail can pass through the guide hole and then through the mounting hole for fixation connection with the clavicle.

[0007] Preferably, the intramedullary nail includes a straight segment and an arc segment, the intramedullary nail is connected to the holder through the straight segment, the mounting hole is disposed on the straight segment, and the extension direction of the straight segment is the same as the extension direction of the aiming device.

[0008] Preferably, the arc segment bends toward the side away from the sight, with an arc radius R in the range of 130-200 rad.

[0009] Preferably, the radial dimension of the straight segment is greater than the radial dimension of the arc segment.

[0010] Preferably, the arc segment includes a front segment, a middle segment, and a rear segment, the arc segment is connected to the straight segment through the front segment, and the rear segment has a beveled cutting structure.

[0011] Preferably, the middle section is a spiral structure arranged along the extension direction of the intramedullary nail.

[0012] Preferably, the middle section is provided with a slotted structure, and the number of slotted structures is multiple, and the multiple slotted structures are arranged at equal intervals along the periphery of the middle section.

[0013] Preferably, the straight segment and the arc segment are smoothly connected, and the intramedullary nail is a one-piece molded structure.

[0014] Preferably, the grip is made of stainless steel, and / or the sight is made of carbon fiber.

[0015] Preferably, the holder has a fixing screw at one end facing the intramedullary nail, the fixing screw being disposed inside the holder to be screwed to the end of the intramedullary nail.

[0016] Based on the above technical solution, the intramedullary nail fixation device described in this application has the following beneficial effects:

[0017] Intramedullary nails can provide axial fixation along the medullary canal of the clavicle, conforming to biomechanical principles, without damaging the periosteum or local blood supply, thus promoting early fracture healing. Simultaneously, the aligned guide holes and mounting holes allow for precise insertion of the transverse locking nail, achieving clavicle fixation and positioning, solving the problems of clavicle fracture fixation and positioning. Compared to traditional plate fixation, intramedullary nail fixation devices offer advantages such as smaller incisions, less intraoperative bleeding, and better postoperative appearance, resolving issues such as the inability of traditional intramedullary fixation devices to provide strong fixation, and the tendency for internal fixation to loosen and shift. Attached Figure Description

[0018] To more clearly illustrate the technical solutions of this application, the accompanying drawings used in the description of the embodiments or prior art will be briefly introduced below. Obviously, the drawings described below are merely some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without any creative effort.

[0019] Figure 1 This is a schematic diagram of the intramedullary nail fixation device provided in the embodiments of this application.

[0020] Figure 2 This is a three-dimensional structural diagram of the holder and intramedullary nail provided in the embodiments of this application.

[0021] Figure 3 This is a front view of the holder and intramedullary nail provided in the embodiments of this application.

[0022] Figure 4 This is a cross-sectional view of the connection between the intramedullary nail and the holder provided in the embodiments of this application.

[0023] Figure 5 This is a three-dimensional structural diagram of the intramedullary nail provided in the embodiments of this application.

[0024] Figure 6 This is a front view of the intramedullary nail provided in the embodiments of this application.

[0025] The reference numerals in the attached drawings are as follows: 100, intramedullary nail fixation device for clavicle, 11, guide hole 111, clavicle fixation component 12, intramedullary nail 13, straight segment 131, arc segment 132, anterior segment 1321, middle segment 1322, posterior segment 1323, mounting hole 133, slotted structure 134, transverse locking screw 14, holder 15, and fixing screw 151. Detailed Implementation

[0026] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of this application.

[0027] The term "an embodiment" or "embodiment" as used herein refers to a specific feature, structure, or characteristic that may be included in at least one implementation of this application. In the description of this application, it should be understood that the terms "upper," "lower," "left," "right," "top," "bottom," etc., indicating orientation or positional relationships based on the orientation or positional relationships shown in the accompanying drawings, are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. Moreover, the terms "first," "second," etc., are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments of this application described herein can be implemented in orders other than those illustrated or described herein.

[0028] Clavicle fractures are a common type of fracture in adults, with the majority being clavicle shaft fractures, and predominantly unstable fractures. This is because the clavicle's anatomical structure is S-shaped, slender, and connects the upper limb and trunk at both ends via the sternoclavicular and acromioclavicular joints. The midshaft (13-22) of the clavicle is superficially located with few surrounding soft tissue attachments, a thin cortical bone, and a small cross-sectional area, making it prone to fracture under direct or indirect force. Currently, most midshaft (13-22) fractures are treated surgically, primarily with plate fixation and intramedullary fixation. While plate fixation is a classic surgical method, it has disadvantages such as significant surgical trauma, substantial disruption of local blood supply, and a high risk of postoperative infection or nonunion. Compared to plate fixation, intramedullary fixation offers advantages such as smaller incisions, less intraoperative bleeding, and better postoperative appearance, conforming to biomechanical principles and promoting early fracture healing. However, intramedullary fixation suffers from drawbacks such as easy loosening and displacement, lack of rigid fixation, and poor mechanical strength and anti-rotation capabilities. Therefore, there is an urgent need for a device for the fixation and positioning of clavicle fractures.

[0029] like Figures 1-6As shown, this application provides a clavicle intramedullary nail fixation device 100, including a clavicle fixation assembly 12, an aiming device 11, and a holder 15. The clavicle fixation assembly 12 is connected to the aiming device 11 via the holder 15, and includes an intramedullary nail 13 and a transverse locking nail 14. The aiming device 11 extends in the same direction as at least a portion of the intramedullary nail 13. The intramedullary nail 13 has a mounting hole 133, and the aiming device 11 has a guide hole 111. The guide hole 111 and the mounting hole 133 are aligned so that the transverse locking nail 14 can pass through the guide hole 111 and then through the mounting hole 133 for fixation connection with the clavicle.

[0030] This design allows the intramedullary nail 13 to provide axial fixation along the medullary canal of the clavicle, conforming to biomechanical principles, without damaging the periosteum or local blood supply, thus promoting early fracture healing. Simultaneously, the aligned guide hole 111 and mounting hole 133 enable the transverse locking nail 14 to precisely penetrate the mounting hole 133, achieving fixation and positioning of the clavicle and resolving the issues of clavicle fracture fixation and positioning. Compared to traditional plate fixation, the intramedullary nail 13 fixation device offers advantages such as smaller incisions, less intraoperative bleeding, and better postoperative appearance, solving problems such as the inability of traditional intramedullary fixation devices to provide strong fixation, and the ease with which internal fixation can loosen and shift.

[0031] like Figures 5-6 As shown, the intramedullary nail 13 includes a straight segment 131 and an arc segment 132. The intramedullary nail 13 is connected to the holder 15 through the straight segment 131. The mounting hole 133 is provided on the straight segment 131. The extension direction of the straight segment 131 is the same as the extension direction of the aiming device 11.

[0032] The design of the straight segment 131 and the curved segment 132 of the intramedullary nail 13 allows it to better adapt to the anatomical structure of the clavicle. The straight segment 131 is connected to the holder 15, ensuring the stability and accuracy of the intramedullary nail 13 and preventing displacement and retraction. The mounting hole 133 is located on the straight segment 131, allowing the aiming device 11 to accurately guide the transverse locking screw 14 through the guide hole 111 and the mounting hole 133, thereby achieving fixation of the intramedullary nail 13 and ensuring the fixation effect of the intramedullary nail 13. The extension direction of the straight segment 131 is consistent with the extension direction of the aiming device 11, ensuring the accuracy of positioning during the operation and improving the precision and efficiency of the operation.

[0033] Therefore, this application solves the connection problem between the intramedullary nail 13 and the holder 15, as well as the positioning problem of the mounting hole 133 of the intramedullary nail 13, by designing the intramedullary nail 13 to include a straight segment 131 and an arc segment 132. Compared with the prior art, the design of this application improves the stability and installation accuracy of the intramedullary nail 13, ensures the accuracy of positioning during surgery, reduces surgical errors, and improves the postoperative recovery effect of patients.

[0034] like Figure 6 As shown, the arc segment 132 bends toward the side opposite to the sight 11, and its arc R is in the range of 130-200 rad.

[0035] The curved segment 132 bends towards the side opposite to the aiming device 11, allowing the intramedullary nail 13 to better adapt to the "S"-shaped anatomy of the clavicle during fixation. The curvature R ranges from 130 to 200 rads, ensuring that the curved segment 132 of the intramedullary nail 13 provides sufficient support and stability during surgery, while avoiding problems such as insecure fixation or stress concentration caused by excessive bending. This design allows the intramedullary nail 13 to better conform to the anatomical shape of the clavicle, providing a more stable fixation effect, reducing the risk of postoperative loosening and displacement of internal fixation, thereby improving the healing effect and surgical success rate of clavicle fractures.

[0036] Specifically, the curvature and direction of the arc segment 132 are designed to conform to the natural curvature of the clavicle medullary cavity, allowing the intramedullary nail 13 to be better embedded within the cavity and improving fixation stability. The curvature R, ranging from 130 to 200 rad, can be achieved through precise bending of the intramedullary nail 13. This arc segment 132 design can be manufactured using CNC bending equipment, ensuring that the curvature of each intramedullary nail 13 is consistent, thereby guaranteeing consistent surgical outcomes.

[0037] Therefore, through the arc-shaped segment 132 design of this application, the intramedullary nail 13 can better adapt to the anatomical shape of the clavicle during clavicle fixation, providing a more stable fixation effect. Compared with the prior art, the design of this application improves the success rate of surgery, reduces the risk of postoperative internal fixation loosening and displacement, and can better promote the healing of clavicle fractures.

[0038] In a preferred embodiment, the radial dimension of the straight segment 131 is larger than that of the curved segment 132. This ensures that the intramedullary nail 13 has different support strengths and stability in different parts of the clavicle, thereby better adapting to the anatomical structure and biomechanical requirements of the clavicle. Through this design, the intramedullary nail 13 provides stronger support in the straight portion of the clavicle and more flexible adaptability in the curved portion, contributing to improved overall fixation effectiveness and stability and resolving the issue of inconsistent radial dimensions in different segments of the intramedullary nail 13.

[0039] Furthermore, the connection between the straight segment 131 and the curved segment 132 can be smoothly achieved through a transition area, ensuring the continuity and stability of the overall structure. As a preferred embodiment, the straight segment 131 and the curved segment 132 can be manufactured using a one-piece molding process, further enhancing the strength and stability of the overall structure.

[0040] Therefore, this application solves the problem of inconsistent radial dimensions of different segments of the intramedullary nail 13 in clavicle fixation devices in the prior art by designing a difference in radial dimensions between the straight segment 131 and the arc segment 132. Compared with the prior art, this design not only improves the fixation effect and stability of the intramedullary nail 13, but also better adapts to the anatomical structure and biomechanical requirements of the clavicle.

[0041] Based on the above, this application also proposes a preferred embodiment in which the straight segment 131 and the arc segment 132 are smoothly connected, and the intramedullary nail 13 is a one-piece molded structure.

[0042] By smoothly connecting the straight segment 131 and the curved segment 132 of the intramedullary nail 13, this design allows the nail to better adapt to the anatomical shape of the clavicle during use, reducing damage to the bone and soft tissues. The one-piece molded structure ensures the overall strength and stability of the intramedullary nail 13, avoiding the potential risk of breakage at the connection site. Through the combination of these technical features, the intramedullary nail 13 can more effectively fix clavicle fractures, improving surgical outcomes and patient recovery quality.

[0043] Furthermore, the smooth connection between the straight segment 131 and the curved segment 132 can be achieved through precision mold manufacturing technology, ensuring that there are no obvious transition marks at the connection, thereby reducing stress concentration.

[0044] The intramedullary nail 13 of this application significantly improves its adaptability and stability through the smooth connection of the straight segment 131 and the arc segment 132, as well as its one-piece molded structure. Compared with the prior art, the intramedullary nail 13 of this application can better conform to the clavicle during surgery, reducing damage to surrounding tissues. At the same time, the one-piece molded structure avoids the risk of breakage at the connection site, improving the fixation effect and the patient's recovery quality.

[0045] like Figure 4 As shown, the arc segment 132 includes a front segment 1321, a middle segment 1322 and a rear segment 1323. The arc segment 132 is connected to the straight segment 131 through the front segment 1321, and the rear segment 1323 is a bevel cutting structure.

[0046] The design of the anterior segment 1321, middle segment 1322, and posterior segment 1323 of the arc-shaped segment 132 allows the intramedullary nail 13 to better adapt to the anatomical shape of the clavicle. The connection between the anterior segment 1321 and the straight segment 131 ensures the stability and fixation effect of the intramedullary nail 13. The beveled cutting structure of the posterior segment 1323 facilitates the insertion and fixation of the intramedullary nail 13 while reducing damage to surrounding tissues. This design effectively solves the design and structural problems of the arc-shaped segment 132 of the clavicle intramedullary nail 13 fixation device 100, improving the success rate of surgery and fracture healing.

[0047] As a preferred embodiment, the middle section 1322 is a spiral structure arranged along the extension direction of the intramedullary nail 13. By adopting the spiral structure design, the solution of this application can effectively solve the problems of stability and fixation effect of the middle section 1322. The spiral structure increases the contact area and friction between the intramedullary nail 13 and the bone, thereby enhancing the fixation effect and preventing the intramedullary nail 13 from loosening and shifting.

[0048] Specifically, the design of the helical structure can be achieved in several ways. For example, a helical groove or protrusion can be machined along the extension direction of the middle section 1322 of the intramedullary nail 13. This increases friction when the intramedullary nail 13 is inserted into the bone, improving the fixation effect. In addition, parameters such as the pitch and helix angle of the helical structure can be adjusted according to actual needs to achieve the best fixation effect and stability.

[0049] In a preferred embodiment, the middle section 1322 is provided with a slotted structure 134, and there are multiple slotted structures 134 arranged at equal intervals along the periphery of the middle section 1322.

[0050] By setting multiple slotted structures 134 in the middle section 1322 and arranging these slotted structures 134 at equal intervals along the periphery of the middle section 1322, the contact area between the intramedullary nail 13 and the bone cavity can be effectively increased, the stability and reliability of the fixation device can be improved, and the problem of the intramedullary nail 13 not being firmly fixed during use can be solved.

[0051] Specifically, the slotted structure 134 can take various forms, such as straight slots, spiral slots, or wavy slots. Multiple slotted structures 134 are arranged at equal intervals along the periphery of the middle section 1322. This arrangement allows the intramedullary nail 13 to be evenly stressed within the bone cavity, further improving the fixation effect.

[0052] As a preferred embodiment, the depth and width of the slotted structure 134 can be adjusted according to actual application requirements to achieve the best fixation effect. Furthermore, the number and spacing of the slotted structures 134 can also be optimized according to different fracture types and locations to meet diverse clinical needs.

[0053] In one preferred embodiment, the gripper 15 is made of stainless steel, and / or the sight is made of carbon fiber.

[0054] The stainless steel gripper 15 possesses high strength and corrosion resistance, ensuring the stability and durability of the device. The carbon fiber sight is lightweight and high-strength, reducing the weight of the device and improving ease of operation and accuracy. Through these technical means, this application solves the material selection problem in the intramedullary nail fixation device 100, ensuring the device's strength, durability, and ease of operation.

[0055] Furthermore, the handle 15 is made of stainless steel, and the handle interface can be tightly fixed to the front section 1321 of the intramedullary nail 13 to ensure smooth insertion of the intramedullary nail 13; the aiming device is made of carbon fiber, which does not show up during the operation and does not obstruct the view, making the operation convenient.

[0056] Meanwhile, the stainless steel grip 15 can be manufactured by precision casting or machining to ensure its dimensional accuracy and surface finish; the carbon fiber sight can be manufactured by composite material molding process to ensure its lightweight and high strength characteristics.

[0057] like Figure 4 As shown, the holder 15 has a fixing screw 151 at one end facing the intramedullary nail 13. The fixing screw 151 is located inside the holder 15 and is screwed to the end of the intramedullary nail 13.

[0058] By incorporating a fixing screw 151 within the holder 15, the fixation effect of the intramedullary nail 13 can be enhanced, preventing loosening and displacement during use, thereby improving the reliability and stability of fixation. The fixing screw 151 not only provides stronger fixation force but also ensures the stability of the intramedullary nail 13 under various operating and usage conditions.

[0059] The foregoing description has fully disclosed the specific embodiments of this application. It should be noted that any modifications made by those skilled in the art to the specific embodiments of this application do not depart from the scope of the claims. Accordingly, the scope of the claims of this application is not limited to the foregoing specific embodiments.

Claims

1. A locking intramedullary nail fixation device, characterized in that, It includes a clavicle fixation assembly, an aiming device, and a holder. The clavicle fixation assembly is connected to the aiming device via the holder. The clavicle fixation assembly includes an intramedullary nail and a transverse locking nail. The aiming device extends in the same direction as at least a portion of the intramedullary nail. The intramedullary nail has a mounting hole, and the aiming device has a guide hole. The guide hole and the mounting hole are aligned so that the transverse locking nail can pass through the guide hole and then through the mounting hole for fixation connection with the clavicle.

2. The intramedullary nail fixation device according to claim 1, characterized in that, The intramedullary nail includes a straight segment and an arc segment. The intramedullary nail is connected to the holder through the straight segment. The mounting hole is disposed on the straight segment. The extension direction of the straight segment is the same as the extension direction of the aiming device.

3. The intramedullary nail fixation device according to claim 2, characterized in that, The arc segment bends toward the side away from the sight, and its arc R is in the range of 130-200 rad.

4. The intramedullary nail fixation device according to claim 2, characterized in that, The radial dimension of the straight segment is greater than the radial dimension of the arc segment.

5. The intramedullary nail fixation device according to claim 2, characterized in that, The arc-shaped segment includes a front section, a middle section, and a rear section. The arc-shaped segment is connected to the straight section through the front section, and the rear section has a beveled cutting structure.

6. The intramedullary nail fixation device according to claim 5, characterized in that, The middle section is a spiral structure arranged along the extension direction of the intramedullary nail.

7. The intramedullary nail fixation device according to claim 5, characterized in that, The middle section is provided with a slotted structure, and there are multiple slotted structures arranged at equal intervals along the periphery of the middle section.

8. The intramedullary nail fixation device according to claim 2, characterized in that, The straight segment and the arc segment are smoothly connected, and the intramedullary nail is a one-piece molded structure.

9. The intramedullary nail fixation device according to claim 1, characterized in that, The grip is made of stainless steel, and / or the sight is made of carbon fiber.

10. The intramedullary nail fixation device according to claim 1, characterized in that, The holder has a fixing screw at one end facing the intramedullary nail. The fixing screw is located inside the holder and is screwed to the end of the intramedullary nail.

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