An imageable all-suture anchor

Abstract

The application relates to the technical field of surgical instruments, in particular to a visualized full-suture anchor, which comprises two traction sutures and a visualized anchor body, the visualized anchor body is provided with movable holes in the length direction of the anchor body, the number of the movable holes is equal to that of the traction sutures, the middle part of one traction suture is movably arranged in one movable hole, and the visualized anchor body can be visualized under X-rays. The application has the effect that the real-time position of the full-suture anchor can be conveniently observed.

Description

Technical Field

[0001] This application relates to the technical field of surgical instruments, and in particular to a radiopaque full suture anchor. Background Technology

[0002] Currently, the advent of suture anchors has revolutionized the way orthopedic surgeons perform upper limb surgery. They enable surgeons to integrate soft tissue with bone, allowing procedures that previously required open surgery to be performed arthroscopically, particularly in shoulder surgeries such as labral repair and rotator cuff repair. Arthroscopic internal fixation has now become the gold standard for treating shoulder instability. With technological advancements, polymer anchors, due to their superior biocompatibility and mechanical properties, are gradually becoming the mainstream choice. This technological revolution has significantly improved surgical safety and postoperative recovery, reduced surgical trauma and complications, and propelled orthopedic surgery towards minimally invasive procedures.

[0003] In addressing the integration of soft tissue and bone, various types of anchors are commonly used in the field. For example, metal suture anchors offer a certain level of strength and stability; there are also polymer anchors, such as fully sutured anchors, PEEK suture anchors, and absorbable suture anchors, with polymer anchors gaining attention for their excellent biocompatibility. These anchors, based on their respective characteristics, meet the needs of different surgical scenarios and patients, playing a vital role in orthopedic surgery.

[0004] However, most common polymer anchors are not radiopaque, which greatly complicates surgical procedures and postoperative observation. Taking glenoid labrum repair surgery as an example, due to the varying thickness of the humerus in each patient, anchors can easily protrude from the glenoid cavity during implantation. Excessive protrusion can damage surrounding nerves and blood vessels. Furthermore, surgeons struggle to accurately determine the anchor's placement during surgery and cannot clearly observe postoperative changes on X-rays, making it difficult to assess the patient's recovery.

[0005] Therefore, there is a problem with the real-time position of fully sutured anchors, and there is an urgent need for a fully sutured anchor that can be visualized. Utility Model Content

[0006] To facilitate observation of the real-time position of the full-suture anchor, this application provides a developable full-suture anchor.

[0007] This application provides a visible, fully sutured anchor, employing the following technical solution: A radiopaque full-suture anchor includes two traction sutures and a radiopaque anchor body. The radiopaque anchor body has movable holes along its own length direction. The number of movable holes is equal to the number of traction sutures. The middle part of one of the traction sutures is movably inserted into one of the movable holes. The radiopaque anchor body can be radiopaque under X-ray.

[0008] By adopting the above technical solution, a movable hole is opened on the radiopaque anchor body, through which the traction suture is movably inserted. This design makes the all-suture anchor structure reasonable and facilitates traction operations. Simultaneously, the radiopaque anchor body can be visualized under X-ray, allowing surgeons to observe the anchor's implantation position and depth in real time during surgery. This enables precise implantation of anchors at the predetermined position and depth even in complex arthroscopic locations, despite limited visibility, preventing surgical failure due to inadequate implantation. It also prevents damage to nerves and blood vessels caused by limited visibility or excessive implantation depth. Furthermore, postoperative X-rays can be used to observe changes in the anchor's position to assess recovery.

[0009] Optionally, the radiopaque nail body includes a first yarn and a second yarn, the first yarn and the second yarn are interwoven to form a rectangle, the movable hole is formed between the first yarn and the second yarn, the first yarn is not radiopaque under X-ray, and the second yarn is radiopaque under X-ray.

[0010] By adopting the above technical solution, the first and second yarns are interwoven, and the second yarn is radiopaque under X-ray, giving the entire radiopaque anchor body that is constructed from them radiopaque. This radiopaque characteristic helps surgeons implant anchors in complex arthroscopic locations with X-ray-assisted positioning, even under limited field of vision, avoiding surgical failure due to inadequate implantation. It also prevents damage to nerves and blood vessels due to excessive implantation depth caused by limited field of vision. Furthermore, the movable hole formed between the first and second yarns facilitates the movement and insertion of the traction suture in the middle, thus simplifying the operation and use of the entire radiopaque suture anchor during surgery.

[0011] Optionally, the first yarn can be visualized under X-ray.

[0012] By adopting the above technical solution, the first yarn becomes radiopaque under X-ray, increasing the radiopaque component of the entire anchor body. This enhances the radiopaque effect of the anchor body under X-ray. When implanting anchors in complex areas under arthroscopy, even with limited field of vision, doctors can more accurately implant the anchors at the predetermined position and depth with X-ray-assisted positioning, reducing the possibility of surgical failure due to inadequate implantation. It also avoids damage to nerves and blood vessels due to limited field of vision or excessive implantation depth. Furthermore, it allows for clearer observation of anchor position changes postoperatively to assess recovery progress.

[0013] Optionally, the ratio of the first yarn to the second yarn can be adjusted.

[0014] By adopting the above technical solution, the ratio of the first yarn to the second yarn can be adjusted flexibly according to actual needs. When better imaging effect is required, increasing the proportion of the second yarn can improve the imaging degree of the full suture anchor under X-ray, allowing doctors to more clearly observe the implantation position of the anchor and postoperative position changes during surgery. If the imaging effect requirement is not high or other factors such as cost are considered, the proportion of the second yarn can be reduced, controlling costs while meeting certain imaging requirements, thereby producing full suture anchors with different imaging effects to adapt to various scenarios.

[0015] Optionally, the traction suture, the first yarn, and the second yarn are all made of ultra-high molecular weight polyethylene.

[0016] By adopting the above technical solution, ultra-high molecular weight polyethylene material has good biocompatibility and mechanical properties. The traction suture, the first yarn, and the second yarn are all made of this material, so that the all-suture anchor inherits these advantages, can better adapt to the human body environment, reduce rejection reactions, and at the same time have sufficient strength to meet the needs of surgery, ensuring that it can play a stable role after being implanted into the human body, thereby improving the success rate of surgery and the postoperative recovery effect of patients.

[0017] Optionally, the developing nail body has pleats on both sides corresponding to the extension directions of the two traction sutures.

[0018] By adopting the above technical solution, folds are set on both sides of the imaging nail body corresponding to the extension direction of the traction suture, which can increase the contact area between the imaging nail body and the surrounding tissue, so that the anchor can better fit and fix with the tissue after being implanted into the human tissue, improve the stability of the anchor implantation, reduce the risk of anchor displacement or loosening, and thus ensure the effect of the surgery and the subsequent recovery.

[0019] Optionally, the traction suture is hollow and has multiple drug penetration holes.

[0020] By adopting the above technical solution, the traction suture is designed as a hollow structure with multiple drug penetration holes. When the traction suture is filled with drugs or related substances, the drugs can be gradually released into the surrounding tissues through the penetration holes, thereby providing continuous drug treatment to the surgical site. This helps to accelerate wound healing, reduce inflammatory response and relieve pain, and improve the surgical treatment effect and the patient's recovery speed.

[0021] Optionally, the traction suture is filled with sustained-release microspheres containing a drug. When the full-suture anchor is implanted into the human body, the sustained-release microspheres can gradually degrade.

[0022] By adopting the above technical solution, since the traction suture is filled with sustained-release microspheres that store drugs, the sustained-release microspheres can gradually degrade after the traction suture is implanted into the human body. This allows the drugs to be slowly released into the human tissues as the sustained-release microspheres degrade, achieving a continuous supply of drugs, which helps to improve the treatment effect and promote patient recovery.

[0023] Optionally, the radiopaque nail body includes a main nail band and a radiopaque band, the radiopaque band being detachably connected to the main nail band, the movable hole being formed between the radiopaque band and the main nail band, and the radiopaque band being radiopaque under X-ray.

[0024] By adopting the above technical solution, during surgery, the imaging belt allows doctors to clearly observe the specific location of the anchor within the body using X-rays. This helps them accurately determine whether the anchor has reached the intended position and depth. Simultaneously, the imaging belt is detachably connected to the main anchor belt, facilitating replacement or adjustment as needed, thus flexibly controlling the anchor's imaging function to meet the requirements of different surgical scenarios. Furthermore, this structural design allows for the separate fabrication of the main anchor belt and the imaging belt during production and assembly, improving production efficiency and reducing costs.

[0025] Optionally, a receiving groove is formed between the imaging tape and the main anchor tape, and a sustained-release capsule is provided in the receiving groove. The sustained-release capsule stores drugs, and the sustained-release capsule can gradually degrade after the full suture anchor is implanted into the human body.

[0026] By adopting the above technical solution, a storage groove is formed between the imaging belt and the main anchor belt, and a sustained-release capsule containing drugs is set. When the full suture anchor is implanted into the human body, as the sustained-release capsule gradually degrades, the drugs can be released slowly, thereby continuously exerting their effects in the body. This is beneficial for promoting the recovery of the surgical site, reducing adverse symptoms such as inflammation, and improving the treatment effect.

[0027] In summary, this application includes at least one of the following beneficial technical effects: 1. The anchor body can be visualized under X-ray, which helps doctors to accurately implant anchors at the predetermined position and depth under X-ray-assisted positioning when implanting complex parts of the arthroscopic procedure, thus avoiding surgical failure caused by inadequate implantation; 2. Through the interaction of traction sutures and sustained-release microspheres, the sustained-release microspheres can gradually degrade after the full-suture anchor is implanted in the human body. This allows the drug to be slowly released into the human tissue as the sustained-release microspheres degrade, achieving a continuous supply of drugs, which helps to improve the treatment effect and promote patient recovery. Attached Figure Description

[0028] Figure 1 This is a schematic diagram of the overall structure of a visible full-suture anchor in Embodiment 1 of this application.

[0029] Figure 2 This is a schematic diagram of the structure of the first yarn and the second yarn in another proportional state in Embodiment 1 of this application.

[0030] Figure 3 This is a schematic diagram of the structure of a visible full-suture anchor in Embodiment 2 of this application.

[0031] Figure 4 This is a partial structural cross-sectional view of the traction suture in Embodiment 3 of this application.

[0032] Figure 5 This is a schematic diagram of the structure of a visible full-suture anchor in Embodiment 4 of this application.

[0033] Figure 6 It is along Figure 5 A partial structural cross-sectional view of line AA in the middle.

[0034] Explanation of reference numerals in the attached figures: 1. Traction suture; 11. Drug penetration hole; 12. Sustained-release microsphere; 2. Imaging staple body; 21. First yarn; 22. Second yarn; 23. Movable hole; 24. Main staple band; 25. Imaging band; 26. Storage groove; 27. Sustained-release capsule. Detailed Implementation

[0035] The following is in conjunction with the appendix Figure 1-6 This application will be described in further detail.

[0036] This application discloses a visible full-suture anchor.

[0037] It should be noted that in the description of this utility model, the terms "center," "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this utility model 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. Therefore, they should not be construed as limitations on this utility model.

[0038] Example 1 Reference Figure 1 and Figure 2 A radiopaque full-suture anchor includes two traction sutures 1 and a radiopaque anchor body 2. The two traction sutures 1 are movably connected to the radiopaque anchor body 2, and the radiopaque anchor body 2 can be visualized under X-ray. In this way, during the operation, the doctor can use X-ray to determine the position of the anchor and ensure the accuracy of implantation.

[0039] The radiopaque nail body 2 includes a first yarn 21 and a second yarn 22. The first yarn 21 is made of white ultra-high molecular weight polyethylene yarn, which is not radiopaque under X-rays. In other embodiments, other yarns of similar material and performance can be used instead, such as ordinary polyethylene yarn.

[0040] The second yarn 22 is made of ultra-high molecular weight polyethylene yarn that has been dyed with Bi2O3 (bismuth trioxide) and is therefore developable under X-rays. In other embodiments, other dyeing agents with developing properties may also be used to treat the yarn.

[0041] The first yarn 21 and the second yarn 22 are interwoven into a rectangle, so that the resulting radiopaque anchor body 2 has both a certain strength and can be visualized under X-ray due to the presence of the second yarn 22. This combination allows the anchor to meet the needs of fixing soft tissue and bone during surgery, while also allowing doctors to observe the position of the anchor in the body in real time.

[0042] In this embodiment, the first yarn 21 and the second yarn 22 are woven using a braiding machine. Furthermore, in actual production, the ratio of the first yarn 21 to the second yarn 22 can be adjusted according to different surgical needs and imaging requirements. It should be noted that in this embodiment, the second yarn 22 accounts for no less than 25% of the total suture anchor to ensure that the surgeon can correctly determine the anchor's position using X-rays.

[0043] Specifically, when a higher developing effect is required, the proportion of the second yarn 22 can be appropriately increased. If the developing nail body 2 is divided into a central area of ​​30%, a transition area of ​​35%, and an edge area of ​​35% from the center to the periphery, then when the proportion of the second yarn 22 in the entire seam anchor does not exceed 50%, at least 50% of the developable portion of the second yarn 22 is distributed in the edge area.

[0044] When the second yarn 22 accounts for 50%-80% of the total suture anchor, at least 50% of the radiopaque portion of the second yarn 22 is distributed in the edge area, and at least 30% of the radiopaque portion of the second yarn 22 is distributed in the central area, thereby ensuring that doctors can easily observe the radiopaque area with the help of X-rays during actual use.

[0045] A movable hole 23 is formed between the first yarn 21 and the second yarn 22. The movable hole 23 is set along the length direction of the imaging nail body 2, and the number of movable holes 23 is equal to the number of traction sutures 1. One traction suture 1 is movably passed through one movable hole 23, thereby making the structure of the full suture anchor reasonable and convenient for doctors to perform traction operations.

[0046] In this embodiment, the traction suture 1 is made of ultra-high molecular weight polyethylene (UHMWPE). UHMWPE has advantages such as high wear resistance and self-lubrication, which makes it convenient for doctors to operate during surgery to accurately implant the full suture anchor into the predetermined position.

[0047] It should be noted that the specific method of implanting the full-suture anchor in this embodiment is a conventional technique for those skilled in the art, and therefore will not be elaborated upon in this embodiment.

[0048] The two sides of the contrast-enhancing nail body 2, corresponding to the extension direction of the two traction sutures 1, are respectively provided with wavy folds, which can increase the contact area between the contrast-enhancing nail body 2 and the surrounding tissue, so that the anchor can better fit and fix with the tissue after being implanted into the human tissue, improve the stability of the anchor implantation, reduce the risk of anchor displacement or loosening, and thus ensure the effect of the surgery and subsequent recovery.

[0049] The implementation principle of a radiopaque full-suture anchor according to an embodiment of this application is as follows: A radiopaque anchor body 2 is formed by cross-weaving an invisible first yarn 21 and a radiopaque second yarn 22, combined with a traction suture 1 made of ultra-high molecular weight polyethylene. This allows the full-suture anchor to possess both good mechanical properties and radiopaque appearance under X-ray. During surgery, the surgeon can use X-rays to observe the anchor's implantation position, avoiding situations such as inadequate or excessive implantation that could damage nerves and blood vessels. Postoperatively, changes in the anchor's position can also be observed to assess recovery.

[0050] Example 2 Reference Figure 1 and Figure 3 The difference between this embodiment and Embodiment 1 is that the first yarn 21 is also dyed with Bi2O3 (bismuth trioxide), enabling it to be visible under X-rays. This effectively improves the imaging effect of the anchor body 2, allowing doctors to more accurately determine the position of the full-suture anchor. During surgery, even with complex anatomical structures or interference from other factors, accurate assessment of anchor implantation can be ensured.

[0051] Example 3 Reference Figure 1 and Figure 4 The difference between this embodiment and embodiment 1 is that the traction suture 1 is hollow and has multiple drug penetration holes 11. The traction suture 1 is filled with sustained-release microspheres 12, and the sustained-release microspheres 12 store drugs.

[0052] In this embodiment, the sustained-release microspheres 12 are made of biodegradable materials, such as polylactic acid, to ensure safe degradation in the human body.

[0053] After the full-suture anchor is implanted into the human body, the sustained-release microspheres 12 can gradually degrade to release the drug, allowing the drug to penetrate smoothly into the surrounding tissues through the drug penetration pores 11, thereby achieving a continuous supply of the drug, which helps to improve the treatment effect and promote patient recovery.

[0054] It should be noted that medications can be selected based on different treatment objectives. For example, antibiotics can prevent infection, while growth factor drugs can promote tissue healing.

[0055] In another preferred embodiment, the sustained-release microspheres 12 may not be provided, and the traction suture 1 may be designed as a soft tube-like structure with drug penetration holes 11 distributed on the traction suture 1, thereby enabling doctors to deliver drugs into the tissue through the traction suture 1.

[0056] Example 4 Reference Figure 5 and Figure 6 The difference between this embodiment and embodiment 1 is that the developing nail body 2 adopts a modular structure. The developing nail body 2 includes a main nail band 24 and a developing band 25. The developing band 25 is detachably connected to the main nail band 24. An active hole 23 is formed between the developing band 25 and the main nail band 24. The developing band 25 can be developed under X-ray.

[0057] In this embodiment, the main anchor band 24 is made of ordinary ultra-high molecular weight polyethylene (UHMWPE) material, primarily serving to provide basic structure and strength. The developing band 25 is made of UHMWPE yarn dyed with Bi2O3, possessing developing functionality. Furthermore, the developing band 25 and the main anchor band 24 are connected and fixed using stitching or binding.

[0058] A receiving groove 26 is formed between the developing belt 25 and the main body staple belt 24. The receiving groove 26 is located between the two movable holes 23, and a sustained-release capsule 27 is filled in the receiving groove 26, which stores the drug. In this embodiment, the sustained-release capsule 27 is made of a biodegradable material, such as polylactic acid.

[0059] Once the full-suture anchor is implanted in the human body, the sustained-release capsule 27 can gradually degrade, thereby slowly releasing the drug, which helps wound healing and reduces the risk of infection.

[0060] The implementation principle of this application embodiment is as follows: by separating the main staple 24 and the radiopaque tape 25, on the one hand, they can be manufactured separately, improving production efficiency and reducing costs; on the other hand, it allows doctors to select the appropriate radiopaque tape 25 according to the actual needs during surgery. Simultaneously, the sustained-release capsule 27 can slowly release drugs after implantation into the human body, playing a role in adjuvant therapy.

[0061] The above are all preferred embodiments of this application and are not intended to limit the scope of protection of this application. Therefore, all equivalent changes made in accordance with the structure, shape and principle of this application should be covered within the scope of protection of this application.

Claims

1. A visible, fully sutured anchor pin, characterized in that: It includes two traction sutures (1) and a radiopaque nail body (2). The radiopaque nail body (2) has movable holes (23) along its own length direction. The number of movable holes (23) is equal to the number of traction sutures (1). The middle part of one of the traction sutures (1) is movably inserted into one of the movable holes (23). The radiopaque nail body (2) can be radiopaqued under X-ray.

2. The radiopaque full-suture anchor according to claim 1, characterized in that: The radiopaque nail body (2) includes a first yarn (21) and a second yarn (22). The first yarn (21) and the second yarn (22) are interwoven into a rectangle. The movable hole (23) is formed between the first yarn (21) and the second yarn (22). The first yarn (21) is not radiopaque under X-ray, while the second yarn (22) is radiopaque under X-ray.

3. The radiopaque full-suture anchor according to claim 2, characterized in that: The first yarn (21) is visible under X-ray.

4. The radiopaque full-suture anchor according to claim 2, characterized in that: The ratio of the first yarn (21) to the second yarn (22) is adjustable.

5. The radiopaque full-suture anchor according to claim 2, characterized in that: The traction suture (1), the first yarn (21) and the second yarn (22) are all made of ultra-high molecular weight polyethylene.

6. The radiopaque full-suture anchor according to claim 1, characterized in that: The developing nail body (2) has pleats on both sides corresponding to the extension directions of the two traction sutures (1).

7. The radiopaque full-suture anchor according to claim 2, characterized in that: The traction suture (1) is hollow and has multiple drug penetration holes (11) on it.

8. The radiopaque full-suture anchor according to claim 7, characterized in that: The traction suture (1) is filled with sustained-release microspheres (12), which store drugs. When the full suture anchor is implanted into the human body, the sustained-release microspheres (12) can gradually degrade.

9. The radiopaque full-suture anchor according to claim 1, characterized in that: The radiopaque nail body (2) includes a main nail band (24) and a radiopaque band (25). The radiopaque band (25) is detachably connected to the main nail band (24). The movable hole (23) is formed between the radiopaque band (25) and the main nail band (24). The radiopaque band (25) is radiopaque under X-ray.

10. The radiopaque full-suture anchor according to claim 9, characterized in that: A receiving groove (26) is formed between the imaging band (25) and the main anchor band (24). A sustained-release capsule (27) is provided in the receiving groove (26). The sustained-release capsule (27) stores drugs. When the full suture anchor is implanted into the human body, the sustained-release capsule (27) can gradually degrade.

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