Bone anchor and connection fixation device

Abstract

The present invention relates to a bone anchor and a connecting and fixing device. The connecting and fixing device includes a suture and a bone anchor, wherein the suture passes through the hollow structure of the bone anchor and is supported by a beam structure; the bone anchor includes a biodegradable nail body, wherein the nail body has a hollow structure for the suture to pass through and a beam structure for supporting the suture, wherein the hollow structure extends along the axial direction of the nail body, the beam structure is arranged inside and / or outside the distal end of the hollow structure, the installation direction of the beam structure is at an angle to the extension direction of the hollow structure, and a reinforcing rib structure is arranged in the beam structure. The present invention enhances the fixing strength at the bonding interface between the suture and the absorbable nail body by the reinforcing rib structure, and during the degradation process of the nail body, the reinforcing rib structure can also effectively maintain the fixing strength between the bone anchor and the suture, thereby effectively reducing the risk of the suture falling out of the bone anchor.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a bone anchor with enhanced fixing strength and a connecting and fixing device. Background Art

[0002] Wire anchors are mostly used for connection and fixation between bones and soft tissues. The anchor head is implanted into the bone surface to form an anchor with the bone. The high-strength suture thread free at the tail end can re-suture and fix tendons, ligaments and other soft tissues to the bone surface, providing simple and efficient anatomical reduction.

[0003] Wire anchors are compact and easy to place, facilitating the transition from open surgery to arthroscopic techniques. Wire anchors are commonly used implants in sports medicine orthopedic surgeries and can be categorized by material as metal, PEEK, and absorbable. First-generation wire anchors are metal devices that offer excellent fixation, but they also present issues such as loosening, migration, and incarceration of the metal implant within the joint, as well as interference with imaging studies. Furthermore, if revision surgery is necessary, metal implants can interfere with the procedure. Therefore, bioresorbable materials have been developed to overcome the shortcomings of metal implants. Initially, absorbable wire anchors maintain the required fixation strength for tissue repair and gradually degrade until they are completely absorbed after tissue repair is complete, thus avoiding or minimizing the risk of migration or interference with revision surgery. Furthermore, absorbable wire anchors are typically radiolucent and non-ferrous, minimizing interference with imaging studies.

[0004] Fixation performance is the most important performance requirement for the clinical application of suture anchors. Pulling out the anchor can lead to surgical failure. The interface where the suture and the anchor are combined (force-bearing contact) has a significant impact on the performance of the anchor. Especially in absorbable suture anchors, as the anchor degrades rapidly, the fixation strength of the anchor at the suture joint is the weakest, which can easily cause the suture to be pulled out of the anchor prematurely. This is one of the places where the product is most likely to fail. Therefore, it is necessary to provide a bone anchor that can improve fixation strength and a connecting and fixing device containing the bone anchor to solve the problem of weak fixation strength of existing absorbable suture anchors.

[0005] It should be noted that the information disclosed in the background technology section of this application is only intended to deepen the understanding of the general background technology of this application, and should not be regarded as an admission or any form of implication that the information constitutes prior art already known to those skilled in the art. Summary of the Invention

[0006] In response to the above technical problems, the present invention proposes a bone anchor and a connecting and fixing device, which can enhance the fixing strength at the interface between the degradable anchor and the suture, prevent the suture from falling out of the anchor prematurely, and ultimately reduce the risk of surgical failure.

[0007] To achieve the above-mentioned objectives, the present invention provides a bone anchor for combining with a suture, comprising a biodegradable nail body, the nail body having a hollow structure for the suture to pass through and a beam structure for supporting the suture, the hollow structure extending along the axial direction of the nail body, the beam structure being arranged inside and / or outside the distal end of the hollow structure, the installation direction of the beam structure being at an angle to the extension direction of the hollow structure, and a reinforcing rib structure being arranged in the beam structure.

[0008] Optionally, the reinforcing rib structure is pre-set in the beam structure, and the nail body and the reinforcing rib structure are integrally injection molded.

[0009] Optionally, the beam structure supports the suture body around a circumferential surface of its own installation direction, and the reinforcing rib structure is extended along the installation direction of the beam structure and is set at a position away from the end side of the beam structure.

[0010] Optionally, the reinforcing rib structure is entirely embedded in the beam structure, or the reinforcing rib structure extends out of the outer wall of the nail body at both ends along the installation direction of the beam structure to form an anti-loosening fixing portion.

[0011] Optionally, the anti-loosening fixing portion is formed by knotting the two ends of the reinforcing rib structure along the installation direction of the beam structure, or the anti-loosening fixing portion is formed by knotting the two ends of the reinforcing rib structure along the installation direction of the beam structure and then thermally curing, or the anti-loosening fixing portion is formed by thermally curing the two ends of the reinforcing rib structure along the installation direction of the beam structure.

[0012] Optionally, the reinforcing rib structure is a flexible structure or a rigid structure.

[0013] Optionally, the reinforcing rib structure is provided with a surface structure, and the surface structure can enhance the bonding force between the reinforcing rib structure and the beam structure.

[0014] Optionally, the surface structure comprises protrusions and / or a coating.

[0015] Optionally, the reinforcing rib structure is a biodegradable structure, and the degradation rate of the reinforcing rib structure is lower than the degradation rate of the nail body.

[0016] Optionally, the nail body is provided with an accommodating space at the front end of the hollow structure, the accommodating space is communicated with the hollow structure, the beam structure is at least partially provided in the accommodating space, the two ends of the beam structure along its own installation direction are fixedly connected to the inner wall of the accommodating space, the beam structure supports the suture body around the circumferential surface of its own installation direction, and a gap is left between the circumferential surface of the beam structure and the inner wall of the accommodating space to allow the suture body to pass through.

[0017] Optionally, the nail body is provided with a hollow on the wall surface of the accommodating space, the hollow corresponds to the position of the beam structure, and the opening direction of the hollow passes through the circumferential surface of the beam structure.

[0018] Optionally, the entire beam structure is arranged in the hollow structure, and the two ends of the beam structure along its own installation direction are fixedly connected to the inner wall of the hollow structure. The beam structure supports the suture body on the circumferential surface around its own installation direction, and a gap is left between the circumferential surface of the beam structure and the inner wall of the hollow structure to allow the suture body to pass through.

[0019] Optionally, the bone anchor has a pointed head structure or a flat head structure.

[0020] To achieve the above objectives, the present invention further provides a connection and fixation device, which comprises a suture and any one of the bone anchors described above, wherein the suture passes through the hollow structure of the bone anchor and is supported by the beam structure.

[0021] Optionally, the number of the sutures is one or more. When the number of the sutures is multiple, all the sutures pass through the hollow structure of the bone anchor at the same time and are supported by the beam structure.

[0022] The bone anchor provided by the present invention utilizes a reinforcing rib structure within the beam structure to enhance the fixing strength at the interface between the suture and the absorbable nail body. In particular, as the nail body degrades, the reinforcing rib structure effectively maintains the fixing strength between the bone anchor and the suture, ultimately effectively reducing the risk of the suture being prematurely dislodged from the bone anchor, thereby reducing the risk of surgical failure. Furthermore, this reinforcing rib design is not limited to use in specific wire anchor products but can also be applied to other wire anchor products of different shapes and sizes, thus offering a wider range of applicability. Furthermore, minimal structural changes to existing wire anchor products are required, thus reducing manufacturing costs.

[0023] Since the connecting and fixing device provided by the present invention and the bone anchor provided by the present invention belong to the same inventive concept, the connecting and fixing device provided by the present invention has all the advantages of the bone anchor provided by the present invention, and therefore the beneficial effects of the connecting and fixing device provided by the present invention will not be described in detail here. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Those skilled in the art will appreciate that the accompanying drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.

[0025] Figure 1 is an overall view of the bone anchor according to the first embodiment of the present invention;

[0026] Figure 2a This is an overall structural diagram of a bone anchor on the front side of a beam structure according to the first embodiment of the present invention;

[0027] Figure 2b is a partially enlarged schematic diagram of a bone anchor at a beam structure according to the first embodiment of the present invention;

[0028] Figure 3 is a cross-sectional structural diagram of a bone anchor according to embodiment 1 of the present invention on the side of a beam structure (i.e., cut along the transverse direction of the beam structure);

[0029] Figure 4 This is an axial cross-sectional view of a bone anchor supporting and fixing a suture according to the first embodiment of the present invention;

[0030] Figure 5 is an overall view of a bone anchor according to a second embodiment of the present invention;

[0031] Figure 6 is a cross-sectional structural diagram of a bone anchor according to a second embodiment of the present invention on the front side of a beam structure (i.e., cut along the axial direction of the beam structure);

[0032] Figure 7 is a cross-sectional structural diagram of a bone anchor on the side of a beam structure according to a second embodiment of the present invention;

[0033] Figure 8 is an overall view of a bone anchor according to a third embodiment of the present invention;

[0034] Figure 9 is a cross-sectional structural diagram of a bone anchor on the front side of a beam structure according to a third embodiment of the present invention;

[0035] Figure 10 is a cross-sectional structural diagram of a bone anchor on the side of a beam structure according to a third embodiment of the present invention;

[0036] Figure 11 is a cross-sectional structural diagram of a bone anchor on the front side of a beam structure according to a fourth embodiment of the present invention;

[0037] Figure 12 1 is a cross-sectional structural diagram of a bone anchor according to embodiment 5 of the present invention on the front side of a beam structure.

[0038] In the attached figure:

[0039] 1-nail body; 2-external thread; 3-hollow structure; 4-nail head; 5-beam structure; 51-circumferential surface of the beam structure; 6-accommodating space; 7-reinforcement rib structure; 71-anti-loosening fixing part; 72-surface structure; 8-hollowing; 10-suture body. DETAILED DESCRIPTION

[0040] Various exemplary embodiments will be described below. These examples are non-limiting and should be understood to illustrate the broader application of the apparatus, system, and method. These embodiments may be varied and replaced by equivalents without departing from the true spirit and scope of the present invention. In addition, various variations may be made to adapt to special circumstances, materials, material compositions, processes, processing actions, or steps to the purpose, spirit, or scope of the present invention. All of these variations are within the scope of protection of the present invention.

[0041] To the extent that any dimensions are described in the Summary or Detailed Description, they are intended to be examples only and are not intended to limit the present subject matter, except as set forth in the various exemplary embodiments. Furthermore, the various configurations of the embodiments described herein are intended to complement one another, rather than to be purely interchangeable, unless otherwise indicated. In other words, configurations from one embodiment can be freely combined with configurations from other embodiments, as readily understood by those skilled in the art, unless such configurations are indicated as being solely interchangeable.

[0042] In this application document, "front end" refers to the end of the bone anchor that first enters the bone surface; "end" refers to the end opposite to the "front end"; "front end" and "end" do not point to the ends of the structure, but are relative positions. For example, the front end of a bone anchor is not the end of the bone anchor, but a position relatively close to the end of the bone anchor. In this application document, "axial" refers to the direction parallel to the axis of the bone anchor; "circumferential" refers to the direction around the axis of the bone anchor; "transverse" refers to the direction perpendicular to the axis. It should be noted that the "biodegradable materials" and "non-biodegradable materials" described in this article are all known conventional materials, and do not involve improvements to the materials; the installation direction of the beam structure described in this article refers to the direction in which the two ends of the beam structure are fixed.

[0043] The core of the present invention is to provide a bone anchor and a connection and fixing device including the bone anchor to solve the problem that the fixing strength of the existing absorbable wire anchor is weak at the support interface, which easily causes the suture to fall out of the anchor prematurely.

[0044] The present invention will be further described below with reference to the accompanying drawings and preferred embodiments. In the absence of conflict, the following embodiments and features in the embodiments may complement or be combined with each other.

[0045] Please refer to Figures 1 to 12, the present application provides a bone anchor for combining with a suture 10. The bone anchor comprises a biodegradable nail body 1. The biodegradable material used to prepare the nail body 1 is a known material, and the specific materials are not described one by one. The nail body 1 can be prepared from a biodegradable polymer material, or from a biodegradable metal material. The biodegradable material can be a polylactic acid-based polymer, or a mixture of a polylactic acid-based polymer and other inorganic small molecules, including but not limited to the above. The nail body 1 has a hollow structure 3 for the suture 10 to pass through, and a beam structure 5 for supporting the suture 10.

[0046] The hollow structure 3 extends axially along the nail body 1 and is often arranged coaxially with the nail body 1. In some embodiments, the hollow structure 3 axially penetrates the entire nail body 1, that is, the end and front end of the nail body 1 are both open ends. In other embodiments, the hollow structure 3 only penetrates the end of the nail body 1, that is, the end of the nail body 1 is an open end and the front end is a closed end. The provision of the hollow structure 3 avoids the suture 10 from being exposed to the outside of the bone anchor and avoids wear between the suture 10 and the bone interface. The hollow structure 3 can have various shapes, and one of the shapes can be selected to achieve it, such as a polygon such as a circle, a quadrilateral or a hexagon, which is not limited in this application. The hollow structure 3 is used for both threading and adapting to the inserter of the bone anchor.

[0047] The beam structure 5 is disposed inside or outside the distal end of the hollow structure 3, or alternatively, a portion of the beam structure 5 is disposed inside the hollow structure 3, while another portion is disposed outside the distal end of the hollow structure 3. The installation direction of the beam structure 5 forms an angle with the extension direction of the hollow structure 3, and the installation direction of the beam structure 5 can be perpendicular or non-perpendicular to the extension direction of the hollow structure 3. The beam structure 5 is typically symmetrically disposed about the axis (central axis) of the hollow structure 3, i.e., the installation direction of the beam structure 5 intersects perpendicularly with the extension direction of the hollow structure 3. In this case, the suture 10 is less likely to slip, and the bone anchor and the suture 10 are evenly stressed.

[0048] The beam structure 5 can have any suitable shape, size and configuration, as long as it can support the suture 10 and prevent the suture 10 from falling out of the bone anchor. The beam structure 5 mainly provides support and fixing force for the suture 10, ensuring the fixing strength of the suture 10 at the support interface (i.e., the bonding interface). Therefore, the fixing strength at the bonding interface between the suture 10 and the bone anchor is mainly ensured by the action of the beam structure 5. The way in which the beam structure 5 supports and fixes the suture 10 includes but is not limited to the method shown in the figure. In the embodiment shown in the figure, the beam structure 5 supports the suture 10 around the circumferential surface 51 of its own installation direction (see Figure 4), so that the suture 10 slides over the circumferential surface 51 of the beam structure 5 and is hung on the beam structure 5. At this time, the circumferential surface 51 of the beam structure 5 should be as smooth as possible, which is not only conducive to the sliding of the suture 10 on its circumferential surface 51, but also reduces the wear of the suture 10. In practice, one or more sutures 10 can be passed through the beam structure 5 to be fixed relative to the bone anchor. Optionally, one to five sutures 10 can be passed through the beam structure 5 to be fixed relative to the bone anchor. Those skilled in the art can also understand that in other implementations, the suture 10 can be passed through the threading hole of the beam structure 5 to support and fix it, but doing so is likely to increase the size of the beam structure 5 and also to reduce the strength of the beam structure 5. Therefore, it is preferred to use the method shown in the figure to support and fix the suture 10.

[0049] In addition, a reinforcing rib structure 7 is provided in the beam structure 5, which enables the bone anchor of the present application to enhance the fixing strength at the interface between the suture body 10 and the beam structure 5 through the reinforcing rib structure 7. In particular, as the nail body 1 degrades, the reinforcing rib structure 7 can effectively maintain the fixing strength between the bone anchor and the suture body 10, ultimately effectively reducing the risk of the suture body 10 being prematurely dislodged from the bone anchor, thereby reducing the risk of surgical failure. It can be understood that the reinforcing rib structure 7 can resist the force applied when the suture body 10 cuts through the support interface of the nail body 1, reducing the risk of failure of the nail body 1 at the support interface.

[0050] It should be understood that compared to metal or PEEK anchors, bioabsorbable anchors have the weakest fixation strength, and the design of this reinforcing rib structure 7 is particularly suitable for biodegradable anchors. After being implanted in the human body, absorbable anchors begin to degrade. When the bone growth rate is lower than the degradation rate of the anchor, the anchor will lose its fixation performance, resulting in surgical failure. In this case, the reinforcing rib structure 7 can improve the fixation strength of the bioabsorbable nail body 1 at the support interface (i.e., the bonding interface), enhancing the fixation effect. In addition, during the gradual degradation of the nail body 1, the reinforcing rib structure 7 can also maintain the strength of the nail body 1 at the weakest point at the support interface. Moreover, this structural design is not limited to use in specific anchor products and can also be applied to other anchor products of different shapes and sizes. Therefore, it has a wider range of applications and requires minimal structural changes to existing wire anchor products, which is conducive to reducing manufacturing costs. It can be understood that the provision of the reinforcing rib structure 7 can maintain or enhance the fixation performance of the biodegradable anchor while achieving minimal changes to existing products.

[0051] As will be understood by those skilled in the art, the bone anchor provided herein is used for implantation into bone, while the suture 10 is used to connect to soft tissue and to draw the soft tissue toward the bone into which the anchor is implanted. Bone anchors are typically elongated, cylindrical, and relatively small in size, sized to fit into a pre-drilled hole formed in bone. The suture 10 can be of any size, quantity, and material as will be understood by those skilled in the art, and this application does not limit this. In the following description, the suture 10 is used as a medical suture for schematic illustration.

[0052] If a reinforcing rib structure 7 is to be provided in the beam structure 5, in terms of current manufacturing technology, a pre-setting process (injection molding process) can be adopted to pre-embed the reinforcing rib structure 7 inside the beam structure 5, so that the nail body 1 and the reinforcing rib structure 7 are integrally injection-molded. This is easy to implement from a manufacturing process perspective, convenient for mass production, and can also ensure the bonding strength between the reinforcing rib structure 7 and the beam structure 5, thereby ensuring the effect of the reinforcing rib structure 7. Of course, this application does not exclude other manufacturing methods that can pre-embed the reinforcing rib structure 7 in the beam structure 5.

[0053] The reinforcing rib structure 7 is preferably reinforced on the entire supporting surface of the beam structure 5. To this end, the reinforcing rib structure 7 is usually required to be extended along both ends of the installation direction of the beam structure 5. The extension length of the reinforcing rib structure 7 can be less than, equal to, or greater than the length of the beam structure 5 along its own installation direction. The reinforcing rib structure 7 can be completely embedded in the beam structure 5, or the reinforcing rib structure 7 can extend from the outer wall (i.e., the outer peripheral surface) of the nail body 1 at both ends of the installation direction of the beam structure 5 to form an anti-loosening fixing portion 71 (see Figure 12 ), the anti-loosening fixing portion 71 can tighten the flexible reinforcing rib structure 7 and enhance its mechanical properties. There are various structures for forming the anti-loosening fixing portion 71, such as: tying the two ends of the reinforcing rib structure 7 along the installation direction of the beam structure 5 to form the anti-loosening fixing portion 71; or tying the two ends of the reinforcing rib structure 7 along the installation direction of the beam structure 5 and then further heat-curing to form the anti-loosening fixing portion 71; or directly heat-curing the two ends of the reinforcing rib structure 7 along the installation direction of the beam structure 5 to form the anti-loosening fixing portion 71. Heat curing is to heat and cure the two ends of the reinforcing rib structure 7, making the reinforcing rib structure 7 tighter and better enhancing its mechanical properties.

[0054] The reinforcing rib structure 7 is fixedly installed through the beam structure 5. The area occupied by the reinforcing rib structure 7 in the beam structure 5 can be large or small, including but not limited to the area and position shown in the figure. In addition to being arranged in the position of the beam structure 5 that is subjected to greater force as shown in the figure, the reinforcing rib structure 7 can also be further extended to the end of the beam structure 5. In the embodiment of the present application, it is only necessary to pre-embed the reinforcing rib structure 7 at the position where the front end of the beam structure 5 is subjected to greater force to achieve the corresponding effect. Preferably, the reinforcing rib structure 7 is arranged at a position away from the end side of the beam structure 5, such as in the horizontal direction perpendicular to the installation direction of the beam structure 5, the beam structure 5 can be provided with the reinforcing rib structure 7 at a position 2 / 3 away from its own end side.

[0055] The material and configuration of the reinforcing rib structure 7 depend at least in part on the material and configuration of the nail body 1, and it must be able to maintain the fixing strength at the bonding interface during the degradation process of the nail body 1. The reinforcing rib structure 7 can be a flexible structure or a rigid structure. The flexible structure can be made of wire or silk, such as directly using medical sutures to prepare the reinforcing rib structure 7. The rigid structure can be a solid or hollow column, and the column has good strength. The flexible structure here is relative to the rigid structure. The flexible structure refers to an object that is easy to deform after being subjected to force, while the rigid structure refers to an object that is not easy to deform after being subjected to force. For example, the reinforcing rib structure 7 can adopt a flexible structure woven or wound by silk threads, the flexible structure can be made of single or multiple strands of silk threads, or the reinforcing rib structure 7 can adopt a rigid column such as a pipe or a rod.

[0056] The reinforcing rib structure 7 can be made of a variety of materials, such as polymers, metals, or composite materials, without limitation. The reinforcing rib structure 7 can be a flexible structure made of polyethylene terephthalate (PET), ultra-high molecular weight polyethylene (UHMWPE), or other polymeric materials. The reinforcing rib structure 7 can be made of either a non-biodegradable material or a biodegradable material, allowing the reinforcing rib structure 7 to also degrade. If the reinforcing rib structure 7 is biodegradable, its degradation rate should be slower than that of the nail body 1.

[0057] The reinforcing rib structure 7 is preferably provided with a surface structure 72 (see Figure 11 ), the surface structure 72 increases the bonding force (adhesion) between the reinforcing rib structure 7 and the beam structure 5, further enhancing mechanical properties. The surface structure 72 can have various configurations, such as protrusions or coatings. Protrusions include, but are not limited to, threads, teeth, spines, barbs, and other structures. The coating can be made of a material that increases friction, with no specific material requirements. Of course, the reinforcing rib structure 7 can also be omitted. The surface structure 72 and the anti-loosening fixing portion 71 can be implemented separately or together.

[0058] In the exemplary embodiment shown in the figure, the bone anchor can be a flat head structure (see Figure 2a 、 Figure 5 、 Figure 8 ) or pointed structure (see Figure 1 If a pointed tip is used, the pointed tip at this time constitutes the nail head 4, such as Figure 1 As shown, the nail head 4 is located at the front end of the nail body 1. The nail head 4 is usually integrally formed with the nail body 1, such as integrally injection molded.

[0059] In addition, the provided bone anchor can be a fully threaded structure, with the external thread 2 extending from the distal end to the nail head 4 at the distal end. This can increase the bonding strength between the bone anchor and the bone and enhance the bone anchor's resistance to pullout. The bone anchor can also be a partially threaded structure. It should also be understood that the location on the bone anchor where the suture 10 is inserted should be as smooth as possible to reduce wear on the suture 10. For example, arcs can be provided at corners, and the edges of holes, notches, grooves, etc. can be smoothed. In addition, the circumferential surface 51 of the beam structure 5 can be designed as an arc surface, such as an arc, an ellipse, or other structures.

[0060] Based on the bone anchor described above, the present application further provides a connection and fixation device, which includes a suture 10 and the bone anchor. The suture 10 passes through the hollow structure 3 of the bone anchor and is supported and fixed by the beam structure 5. The number of sutures 10 is one or more. When the number of sutures 10 is multiple, all sutures 10 pass through the hollow structure 3 of the bone anchor at the same time and are supported and fixed by the same beam structure 5.

[0061] The present application also provides a method for preparing the above-mentioned bone anchor nail, which uses a pre-setting process to embed a reinforcing rib structure 7 inside the beam structure 5 of the nail body 1, so that the reinforcing rib structure 7 and the nail body 1 are integrally injection-molded.

[0062] The bone anchor proposed in this application will be further described below in conjunction with several exemplary embodiments.

[0063] [Example 1]

[0064] Reference Figures 1 to 4 As shown, in the bone anchor provided by the first embodiment, the bone anchor further comprises a nail head 4, which is arranged at the front end of the nail body 1, and the two are more integrally injection molded. The outer surfaces of the nail head 4 and the nail body 1 both have external threads 2.

[0065] like Figure 2a-2b and Figure 3As shown, the interior of the nail body 1 is provided with a hollow structure 3 (hole or cavity) and a receiving space 6. The receiving space 6 is located at the front end of the hollow structure 3 and is connected to the hollow structure 3. The hollow structure 3 only passes through the end face of the nail body 1, and the beam structure 5 is at least partially arranged in the hollow structure 3. The two ends of the beam structure 5 along its own installation direction are fixedly connected to the inner wall of the receiving space 6. While the beam structure 5 supports the suture body 10 around the circumferential surface 51 of its own installation direction, a gap is left between the circumferential surface 51 of the beam structure 5 and the inner wall of the receiving space 6 to pass the suture body 10. The gap here is connected to the hollow structure 3. It can be understood that the beam structure 5 divides the part where the front end of the hollow structure 3 is connected to the receiving space 6 into two parts, so that the suture body 10 can pass through the beam structure 5 and the hollow structure 3.

[0066] like Figure 1 、 Figure 2b As shown, in an exemplary embodiment, the nail body 1 is provided with a hollow 8 on the wall surface of the accommodating space 6. The hollow 8 corresponds to the position of the beam structure 5, and the opening direction of the hollow 8 passes through the circumferential surface 51 of the beam structure 5. The provision of the hollow 8 makes it easier for the operator (such as a doctor) to touch the circumferential surface 51 of the beam structure 5 or the suture 10 at that position through the hollow 8, and the hollow 8 here can also reduce the friction between the suture 10 and the bone anchor. However, the hollow 8 is not a mandatory condition, and the hollow 8 can also be eliminated so that the beam structure 5 cannot be seen or touched. Figure 3 and Figure 4 As shown, the reinforcing rib structure 7 is fixedly arranged through the beam structure 5. The reinforcing rib structure 7 is preferably arranged at a position close to the front end support surface of the beam structure 5, for example Figure 4 In an exemplary embodiment, the reinforcing rib structure 7 is a flexible structure made of ultra-high molecular weight polyethylene material, which is pre-set in the beam structure 5.

[0067] When it is necessary to fix the relative position of the suture body 10 and the nail body 1, one free end of the suture body 10 is made to enter the hollow structure 3 from the end open end of the nail body 1, and the free end of the suture body 10 is continuously moved toward the direction of the beam structure 5. When the free end of the suture body 10 moves to the position of the beam structure 5, the suture body 10 is offset in the direction close to the inner wall of the accommodating space 6 until the free end of the suture body 10 enters one of the gaps formed between the circumferential surface 51 of the beam structure 5 and the inner wall of the accommodating space 6. After passing through one of the gaps, the free end of the suture body 10 is turned 180° and then enters from the gap between the nail head 4 and the front end of the beam structure 5 into another gap formed between the circumferential surface 51 of the beam structure 5 and the inner wall of the accommodating space 6. After passing through the other gap, the free end of the suture body 10 enters the hollow structure 3 again, that is, a circle of winding is completed, and the suture body 10 is relatively fixed relative to the bone anchor on the beam structure 5.

[0068] [Example 2]

[0069] The bone anchor provided in the second embodiment of the present application is substantially the same as the bone anchor provided in the first embodiment, and the same parts will not be described again. Only the differences will be described below.

[0070] Reference Figures 5 to 7 As shown, unlike the first embodiment, the bone anchor provided in the second embodiment does not have a nail head 4, so as to form a bone anchor with a flat head structure, which allows the hollow 8 to directly penetrate the front end surface of the nail body 1 (see Figure 5 ), and the accommodating space 6 and the beam structure 5 are completely exposed at the front end of the nail body 1. In other words, a U-shaped notch is formed at the front end of the nail body 1.

[0071] In another exemplary embodiment, the reinforcing rib structure 7 is a flexible structure made of polyethylene terephthalate material, which is pre-set in the beam structure 5 .

[0072] like Figure 6 As shown, in an exemplary embodiment, the reinforcing rib structure 7 extends out of the nail body 1 at both ends along the installation direction of the beam structure 5 and reaches the outside of the nail body 1.

[0073] like Figure 6 As shown, in one example, the surface of the reinforcing rib structure 7 is not provided with a surface structure.

[0074] Since the nail head 4 is not provided, the threading method can also be as follows: when it is necessary to fix the relative position of the suture body 10 and the nail body 1, one free end of the suture body 10 is made to enter the hollow structure 3 from the end open end of the nail body 1, and the free end of the suture body 10 is continuously moved toward the direction of the beam structure 5. When the free end of the suture body 10 moves to the position of the beam structure 5, the suture body 10 is offset in the direction close to the inner wall of the accommodating space 6 until the free end of the suture body 10 enters one of the gaps formed between the circumferential surface 51 of the beam structure 5 and the inner wall of the accommodating space 6. After passing through one of the gaps, the free end of the suture body 10 is turned 180°. At this time, since there is no nail head 4, after the turn, the free end of the suture body 10 can directly enter the other gap formed between the circumferential surface 51 of the beam structure 5 and the inner wall of the accommodating space 6. After passing through the other gap, the free end of the suture body 10 enters the hollow structure 3 again, that is, one circle of winding is completed, and the suture body 10 is relatively fixed relative to the bone anchor on the beam structure 5.

[0075] [Example 3]

[0076] The bone anchor provided in the third embodiment of the present application is substantially the same as the bone anchor provided in the first and second embodiments above, and the same parts will not be described again, and only the differences will be described below.

[0077] Reference Figures 8 to 10 As shown, unlike the first and second embodiments, in the bone anchor provided by the third embodiment, the beam structure 5 is entirely disposed in the hollow structure 3, and there is no need to provide an accommodating space 6 and no hollowing 8 is provided.

[0078] like Figure 9 and Figure 10 As shown, the bone anchor has a flat head structure, and the hollow structure 3 axially penetrates the nail body 1. Specifically, the beam structure 5 is fixedly connected to the inner wall of the hollow structure 3 at both ends along its own installation direction. The beam structure 5 supports the suture 10 around the circumferential surface 51 of its own installation direction. A gap is left between the circumferential surface 51 of the beam structure 5 and the inner wall of the hollow structure 3 to allow the suture 10 to pass through. At this time, the beam structure 5 directly divides the portion of the hollow structure 3 at a certain position inside into two parts for routing.

[0079] In an exemplary embodiment, the reinforcing rib structure 7 may be a cylindrical rigid structure, pre-installed in the beam structure 5 .

[0080] like Figure 9 As shown, both ends of the reinforcing rib structure 7 along the installation direction of the beam structure 5 can be embedded in the nail body 1 and are not exposed to the outside of the nail body 1.

[0081] like Figure 9 As shown, in one example, the surface of the reinforcing rib structure 7 is not provided with a surface structure.

[0082] When the beam structure 5 is completely set in the hollow structure 3, the threading process may include: allowing one free end of the suture body 10 to enter the hollow structure 3 from the end open end of the nail body 1, and allowing the free end of the suture body 10 to continuously move toward the direction of the beam structure 5; when the free end of the suture body 10 moves to the position of the beam structure 5, the suture body 10 is offset in the direction close to the inner wall of the hollow structure 3 until the free end of the suture body 10 enters one of the gaps formed between the circumferential surface 51 of the beam structure 5 and the inner wall of the hollow structure 3; after passing through one of the gaps, the free end of the suture body 10 is turned 180°; after turning, the free end of the suture body 10 directly enters another gap formed between the circumferential surface 51 of the beam structure 5 and the inner wall of the hollow structure 3; and finally enters the part of the hollow structure 3 that is not separated by the beam structure 5, that is, completing one circle of winding, and realizing the relative fixation of the suture body 10 relative to the bone anchor on the beam structure 5.

[0083] [Example 4]

[0084] The bone anchor provided in the fourth embodiment of the present application is substantially the same as the bone anchor provided in the third embodiment, and the same parts will not be described again. Only the differences will be described below.

[0085] Reference Figure 11Unlike the third embodiment, the bone anchor provided in the fourth embodiment uses a rigid reinforcing rib structure 7 and provides a surface structure 72 on the surface of the reinforcing rib structure 7. The surface structure 72 may be formed by threads or barbs, thereby further enhancing the bonding force between the reinforcing rib structure 7 and the beam structure 5. It should be understood that the surface structure 72 may have different or identical configurations.

[0086] [Example 5]

[0087] The bone anchor provided in the fifth embodiment of the present application is substantially the same as the bone anchors provided in the third and fourth embodiments. The same parts will not be described again, and only the differences will be described below.

[0088] Reference Figure 12 Unlike the third and fourth embodiments, the fifth embodiment provides a bone anchor in which the rib structure 7 is flexible and extends beyond the nail body 1 at both ends along the installation direction of the beam structure 5 to form anti-loosening fixing portions 71. The anti-loosening fixing portions 71 can be formed on the exterior of the nail body 1 by knotting, heat curing, knotting plus heat curing, or other methods, thereby enhancing the bonding strength between the rib structure 7 and the nail body 1.

[0089] In summary, fixation strength is the most important performance requirement for bone anchors such as wire anchors in clinical applications. Especially in absorbable anchors, the interface between the suture and the anchor will collapse during the degradation process, causing the suture to be prematurely removed from the anchor, which is one of the places where the product is most likely to fail. Furthermore, after applying the bone anchor provided by the present invention, the load of the suture cutting through the absorbable anchor support interface can be resisted by the reinforcing rib structure, thereby enhancing the fixation strength and fixation effect at the interface. On the other hand, during the degradation process, the pre-installed reinforcing rib structure can further maintain the fixation strength between the suture and the anchor when the interface collapses, thereby resolving the mechanical weakness between the suture and the anchor and reducing the risk of surgical failure.

[0090] Since the connecting and fixing device provided by the present invention and the bone anchor provided by the present invention belong to the same inventive concept, the connecting and fixing device provided by the present invention has all the advantages of the bone anchor provided by the present invention, and therefore the beneficial effects of the connecting and fixing device provided by the present invention will not be described in detail here.

[0091] It should be noted that the various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. Reference can be made to the common and similar parts between the various embodiments. The systems disclosed in the embodiments are described briefly because they correspond to the methods disclosed in the embodiments. For relevant details, refer to the method description.

[0092] It should also be noted that although the present invention has been disclosed above with reference to preferred embodiments, the above embodiments are not intended to limit the present invention. For any person skilled in the art, without departing from the scope of the technical solution of the present invention, the technical content disclosed above can be used to make many possible changes and modifications to the technical solution of the present invention, or to modify it into an equivalent embodiment with equivalent changes. Therefore, any simple modification, equivalent change, and modification made to the above embodiments based on the technical essence of the present invention without departing from the content of the technical solution of the present invention still fall within the scope of protection of the technical solution of the present invention.

[0093] It should also be understood that, unless otherwise specified or indicated, the terms "first", "second", "third", etc. in the specification are only used to distinguish the various components, elements, steps, etc. in the specification, and are not used to indicate the logical relationship or sequential relationship between the various components, elements, steps, etc.

[0094] It should also be understood that the terms described herein are intended to describe particular embodiments only and are not intended to limit the scope of the invention. It should be noted that the singular forms "a" and "an" as used herein and in the appended claims include plural references unless the context clearly indicates otherwise. For example, a reference to "a step" or "a device" means a reference to one or more steps or devices, and may include secondary steps as well as secondary devices. All conjunctions used should be understood in their broadest sense. Also, the word "or" should be understood to have the definition of a logical "or" rather than a logical "exclusive or" unless the context clearly indicates otherwise. Furthermore, implementation of the methods and / or apparatus in embodiments of the present invention may include performing selected tasks manually, automatically, or in combination.

Claims

1. A bone anchor for use in conjunction with a suture, characterized in that: It includes a biodegradable nail body, which has a hollow structure for the suture to pass through and a beam structure for supporting the suture. The hollow structure extends along the axial direction of the nail body and axially penetrates the entire nail body or only penetrates the end of the nail body. The beam structure is arranged inside and / or outside the distal end of the hollow structure. The installation direction of the beam structure is at an angle to the extension direction of the hollow structure. A reinforcing rib structure is provided in the beam structure, and the reinforcing rib structure is completely embedded in the beam structure. Alternatively, the reinforcing rib structure extends out of the outer wall of the nail body at both ends of the installation direction of the beam structure and forms an anti-loosening fixing portion.

2. The bone anchor according to claim 1, wherein: The reinforcing rib structure is pre-set in the beam structure, and the nail body and the reinforcing rib structure are integrally injection-molded.

3. The bone anchor according to claim 1 or 2, characterized in that: The beam structure supports the suture body around a circumferential surface of its own installation direction, and the reinforcing rib structure is extended along the installation direction of the beam structure and is set at a position away from the end side of the beam structure.

4. The bone anchor according to claim 1 or 2, characterized in that: The anti-loosening fixing portion is formed by knotting the two ends of the reinforcing rib structure along the installation direction of the beam structure, or the anti-loosening fixing portion is formed by knotting the two ends of the reinforcing rib structure along the installation direction of the beam structure and then thermally solidifying, or the anti-loosening fixing portion is formed by thermally solidifying the two ends of the reinforcing rib structure along the installation direction of the beam structure.

5. The bone anchor according to claim 1 or 2, characterized in that: When the reinforcing rib structure extends out of the nail body at both ends along the installation direction of the beam structure, the reinforcing rib structure is a flexible structure, or when the reinforcing rib structure is fully embedded in the beam structure, the reinforcing rib structure is a rigid structure.

6. The bone anchor according to claim 1 or 2, characterized in that: The reinforcing rib structure is provided with a surface structure, and the surface structure can enhance the bonding force between the reinforcing rib structure and the beam structure.

7. The bone anchor according to claim 6, wherein: The surface structure comprises protrusions and / or a coating.

8. The bone anchor according to claim 1 or 2, characterized in that: The reinforcing rib structure is a biodegradable structure, and the degradation rate of the reinforcing rib structure is lower than the degradation rate of the nail body.

9. The bone anchor according to claim 1 or 2, characterized in that: The nail body is provided with a accommodating space at the front end of the hollow structure, and the accommodating space is communicated with the hollow structure. The beam structure is at least partially arranged in the accommodating space, and the two ends of the beam structure along its own installation direction are fixedly connected to the inner wall of the accommodating space. The beam structure supports the suture body around the circumferential surface of its own installation direction, and a gap is left between the circumferential surface of the beam structure and the inner wall of the accommodating space to allow the suture body to pass through.

10. The bone anchor according to claim 9, wherein: The nail body is provided with a hollow on the wall surface of the accommodating space, the hollow corresponds to the position of the beam structure, and the opening direction of the hollow passes through the circumferential surface of the beam structure.

11. The bone anchor according to claim 1 or 2, characterized in that: The beam structure is entirely arranged in the hollow structure, and the two ends of the beam structure along its own installation direction are fixedly connected to the inner wall of the hollow structure. The beam structure supports the suture body on the circumferential surface around its own installation direction, and a gap is left between the circumferential surface of the beam structure and the inner wall of the hollow structure to allow the suture body to pass through.

12. The bone anchor according to claim 1 or 2, characterized in that: The bone anchor has a pointed head structure or a flat head structure.

13. A connecting and fixing device, characterized in that: The invention comprises a suture and the bone anchor according to any one of claims 1 to 12, wherein the suture passes through the hollow structure of the bone anchor and is supported by the beam structure.

14. The connecting and fixing device according to claim 13, characterized in that: The number of the sutures is one or more. When the number of the sutures is plural, all the sutures pass through the hollow structure of the bone anchor at the same time and are supported by the beam structure.

Images