CN111714173A - A new type of fixation nail for ligament around the knee joint - Google Patents

Abstract

Translated fromChinese

本发明公开了一种新型膝关节周围韧带止点固定钉，所述固定钉包括固定钉本体和垫圈；所述固定钉本体包括钉头和钉尾；所述钉头为自攻钉；所述垫圈套设于所述钉尾的外侧。采用本发明提供的固定钉能够保证侧副韧带的有效固定，促进其愈合；并可有效避免髌韧带撕脱。该固定钉固定效果好、操作简单，成本低，易于大规模推广。

The invention discloses a novel fixing nail for ligament stop point around the knee joint. The fixing nail comprises a fixing nail body and a washer; the fixing nail body includes a nail head and a nail tail; the nail head is a self-tapping nail; The washer is sleeved on the outer side of the nail tail. The fixation nail provided by the invention can ensure the effective fixation of the collateral ligament, promote its healing, and can effectively avoid the avulsion of the patellar ligament. The fixing nail has good fixing effect, simple operation, low cost, and is easy to be popularized on a large scale.

Description

Translated fromChinese

一种新型膝关节周围韧带止点固定钉A new type of fixation nail for ligament around the knee joint

技术领域technical field

本发明属于医疗器械技术领域，具体地说，涉及一种新型膝关节周围韧带止点固定钉。The invention belongs to the technical field of medical devices, and in particular relates to a novel fixation nail for the ligament around the knee joint.

背景技术Background technique

膝关节侧副韧带损伤常见于肥胖、骨质疏松、炎性关节病、严重膝外翻畸形、既往多次手术史的患者。虽然是罕见的并发症，但仍可导致术后膝关节不稳定、植入物加速磨损、最终失败翻修或二次手术等不良后果。对于侧副韧带的体部损伤，可以采用缝合、自体肌腱移植和合成材料进行修复。而韧带止点的损伤尤其是撕脱伤需要用缝合锚、垫片螺钉、门型钉或其它固定器来治疗。但以上固定方式均不能提供足够的抓持力来固定撕脱的骨块和/或移植的肌腱韧带，易发生韧带止点的再次撕脱。Collateral ligament injuries are common in patients with obesity, osteoporosis, inflammatory arthropathy, severe knee valgus deformity, and a history of multiple previous surgeries. Although a rare complication, it can lead to postoperative knee instability, accelerated implant wear, and eventual failure of revision or secondary surgery. Body injuries to the collateral ligaments can be repaired with sutures, autologous tendon grafts, and synthetic materials. Injuries to the ligament insertion, especially avulsion injuries, require treatment with suture anchors, spacer screws, portal nails, or other fixators. However, none of the above fixation methods can provide sufficient gripping force to fix the avulsed bone fragment and/or the transplanted tendon and ligament, which is prone to re-avulsion of the ligament insertion point.

因此如何保证侧副韧带的有效固定，为它的愈合创造良好的条件，以及避免发生髌韧带撕脱，成为摆在临床医生面前的一个难题。Therefore, how to ensure the effective fixation of the collateral ligament, create favorable conditions for its healing, and avoid patellar ligament avulsion has become a difficult problem for clinicians.

为了解决传统固定方式抓持力差的问题，科研人员发明了新型的膝关节手术韧带固定器。其采用固定板的设计，可以有效提高压紧面积，使韧带结构受力均匀。针对膝关节侧副韧带损伤的固定板的横截面为矩形，四角均有锥形的立柱，且立柱设计有圆形凹槽，以加强咬合。固定板有一个中央孔用于螺钉连接，在周围有6个针孔用于穿线加强缝合韧带。手术中先用固定板将撕脱的骨块原位固定，轻轻锤击，使固定板与骨质咬合；然后通过固定板的中央孔用3.2mm钻制备通道，并使用测深仪评估通道长度；最后拧入膨胀式螺钉，包括有具有内腔的膨胀螺钉和嵌在所述内腔中的内芯，膨胀螺钉胀开并与股骨髁抵紧。In order to solve the problem of poor grasping force of traditional fixation methods, researchers have invented a new type of knee joint surgery ligament fixator. It adopts the design of the fixed plate, which can effectively increase the compression area and make the ligament structure evenly stressed. The cross-section of the fixation plate for knee collateral ligament injury is rectangular, and the four corners have tapered uprights, and the uprights are designed with circular grooves to strengthen the bite. The fixation plate has a central hole for screw connection and 6 pinholes around the perimeter for threading and reinforcing the suture ligament. During the operation, the avulsed bone fragment was fixed in situ with a fixation plate, and the fixation plate was occluded with the bone by lightly hammering; then a 3.2mm drill was used to prepare a channel through the central hole of the fixation plate, and a depth sounder was used to evaluate the channel. Length; finally screw in an expansion screw, including an expansion screw with an inner cavity and an inner core embedded in the inner cavity, the expansion screw is expanded and pressed against the femoral condyle.

虽然上述膝关节手术韧带固定器提升了抓持力，但是依旧有以下缺点：一是需要固定板、固定钉组配式固定；二是固定板没有把持器械，固定钉的植入需要先用钻头及测深尺；三是固定钉有两种：一种是普通的直径6.5mm的松质骨螺钉需要双皮质固定不能单皮质固定，另一种是膨胀式螺钉需要组配操作繁琐。Although the above-mentioned knee joint surgery ligament fixator improves the grasping force, it still has the following disadvantages: firstly, it requires a fixed plate and a fixed nail to be fixed in combination; There are two types of fixation screws: one is the common cancellous bone screw with a diameter of 6.5mm that requires bicortical fixation and cannot be fixed with single cortex, and the other is the expansion screw that requires complicated operation.

综上所述，如何保证侧副韧带的有效固定，为它的愈合创造良好的条件，以及避免发生髌韧带撕脱，成为摆在临床医生面前的一个难题。In summary, how to ensure the effective fixation of the collateral ligament, create favorable conditions for its healing, and avoid patellar ligament avulsion has become a difficult problem for clinicians.

发明内容SUMMARY OF THE INVENTION

为了解决现有技术中侧副韧带固定时存在的问题，本发明提供了一种新型膝关节周围韧带止点固定钉。In order to solve the problems existing in the fixation of the collateral ligament in the prior art, the present invention provides a new fixation nail for the ligament around the knee joint.

根据本发明的一个方面，提供一种新型膝关节周围韧带止点固定钉，所述固定钉包括固定钉本体和垫圈；According to one aspect of the present invention, there is provided a novel fixation pin for ligament around the knee joint, the fixation pin includes a fixation pin body and a washer;

所述固定钉本体包括钉头和钉尾；The fixing nail body includes a nail head and a nail tail;

所述钉头为自攻钉；The screw head is a self-tapping screw;

所述垫圈套设于所述钉尾的外侧。The washer is sleeved on the outer side of the nail tail.

根据本发明的一个具体实施方式，所述垫圈的内缘和所述钉尾的外缘分别设置有锯齿结构，According to a specific embodiment of the present invention, the inner edge of the washer and the outer edge of the nail tail are respectively provided with sawtooth structures,

所述钉尾与所述垫圈通过上述锯齿结构匹配连接。The nail tail and the washer are matched and connected through the sawtooth structure.

根据本发明的另一个具体实施方式，所述垫圈上设置有至少一个锥形凸起。According to another specific embodiment of the present invention, at least one conical protrusion is provided on the washer.

根据本发明的又一个具体实施方式，所述垫圈上设置有穿线孔，所述穿线孔用于缝合线走线。According to yet another specific embodiment of the present invention, a threading hole is provided on the gasket, and the threading hole is used for suture routing.

根据本发明的又一个具体实施方式，所述穿线孔的直径为1.2mm。According to yet another specific embodiment of the present invention, the diameter of the threading hole is 1.2 mm.

根据本发明的又一个具体实施方式，所述固定钉采用钛合金材质制备，在所述钛合金材质上覆有羟基磷灰石涂层。According to another specific embodiment of the present invention, the fixing nail is made of a titanium alloy material, and the titanium alloy material is covered with a hydroxyapatite coating.

根据本发明的又一个具体实施方式，所述羟基磷灰石涂层的厚度为50μm。According to yet another specific embodiment of the present invention, the thickness of the hydroxyapatite coating is 50 μm.

根据本发明的又一个具体实施方式，所述固定钉本体的直径为8.0mm。According to yet another specific embodiment of the present invention, the diameter of the fixing nail body is 8.0 mm.

根据本发明的又一个具体实施方式，所述固定钉本体的长度在2cm～8cm之间。According to yet another specific embodiment of the present invention, the length of the fixing nail body is between 2 cm and 8 cm.

根据本发明的又一个具体实施方式，所述固定钉本体为一体式结构。According to yet another specific embodiment of the present invention, the fixing nail body is a one-piece structure.

本发明提供的固定钉由固定钉本体和垫圈组成，无需额外使用固定板；此外，固定钉本体采用自攻钉，无需进行钻头测深。本发明提供的固定钉结构简单、操作便捷，且制备成本较低。另外，垫圈与固定钉本体之间能形成稳定不变的结构，在实际应用过程中，能够提供足够的抓持力来固定撕脱的骨块和或者移植的肌腱韧带，不会发生韧带止点的再次撕脱。The fixing nail provided by the present invention is composed of a fixing nail body and a washer, and no additional fixing plate is required; in addition, the fixing nail body adopts a self-tapping screw, and no drill depth measurement is required. The fixing nail provided by the invention is simple in structure, convenient in operation and low in manufacturing cost. In addition, a stable and invariable structure can be formed between the washer and the fixation nail body, which can provide sufficient gripping force to fix the avulsed bone fragment and or the transplanted tendon and ligament without ligament insertion during practical application. tear off again.

本发明提供的固定钉能够实现侧副韧带的有效固定，为其愈合创造良好的条件，并可有效避免发生髌韧带撕脱。The fixation nail provided by the invention can realize the effective fixation of the collateral ligament, create favorable conditions for its healing, and can effectively avoid the avulsion of the patellar ligament.

附图说明Description of drawings

通过阅读参照以下附图所作的对非限制性实施例所作的详细描述，本发明的其它特征、目的和优点将会变得更明显：Other features, objects and advantages of the present invention will become more apparent by reading the detailed description of non-limiting embodiments made with reference to the following drawings:

图1所示为根据本发明提供的一种新型膝关节周围韧带止点固定钉的一个具体实施方式的结构示意图；FIG. 1 is a schematic structural diagram of a specific embodiment of a novel ligament fixation pin around the knee joint provided by the present invention;

图2所示为根据本发明提供的一种新型膝关节周围韧带止点固定钉的一个具体实施方式的侧视图；Fig. 2 shows a side view of a specific embodiment of a novel ligament fixation nail around the knee joint provided by the present invention;

图3所示为根据本发明提供的一种新型膝关节周围韧带止点固定钉的垫圈的一个具体实施方式的结构示意图；3 is a schematic structural diagram of a specific embodiment of a washer of a novel ligament fixation pin around the knee joint provided by the present invention;

图4所示为根据本发明提供的一种新型膝关节周围韧带止点固定钉的固定钉本体的一个具体实施方式的结构示意图。Fig. 4 is a schematic structural diagram of a specific embodiment of a fixation pin body of a novel fixation pin for ligament around the knee joint provided by the present invention.

附图中相同或相似的附图标记代表相同或相似的部件。The same or similar reference numbers in the drawings represent the same or similar parts.

具体实施方式Detailed ways

下文的公开提供了许多不同的实施例或例子用来实现本发明的不同结构。为了简化本发明的公开，下文中对特定例子的部件和设置进行描述。此外，本发明可以在不同例子中重复参考数字和/或字母。这种重复是为了简化和清楚的目的，其本身不指示所讨论各种实施例和/或设置之间的关系。应当注意，在附图中所图示的部件不一定按比例绘制。本发明省略了对公知组件和处理技术及工艺的描述以避免不必要地限制本发明。The following disclosure provides many different embodiments or examples for implementing different structures of the invention. In order to simplify the disclosure of the present invention, the components and arrangements of specific examples are described below. Furthermore, the present invention may repeat reference numerals and/or letters in different instances. This repetition is for the purpose of simplicity and clarity and does not in itself indicate a relationship between the various embodiments and/or arrangements discussed. It should be noted that the components illustrated in the figures are not necessarily drawn to scale. Descriptions of well-known components and processing techniques and processes are omitted from the present invention to avoid unnecessarily limiting the present invention.

参见图1～图4，本发明提供了一种新型膝关节周围韧带止点固定钉。所述固定钉包括固定钉本体10和垫圈20。所述固定钉本体10包括钉头11和钉尾12。所述钉头11为自攻钉，因此，在具体植入过程中，无需钻头等辅助器械，操作更简单。Referring to Fig. 1 to Fig. 4, the present invention provides a novel fixation nail for ligament around the knee joint. The fixing nail includes afixing nail body 10 and awasher 20 . Thefixing nail body 10 includes anail head 11 and anail tail 12 . Thescrew head 11 is a self-tapping screw, therefore, in the specific implantation process, auxiliary instruments such as a drill are not required, and the operation is simpler.

所述垫圈20套设于所述钉尾12的外侧。参见图3，所述垫圈20的内缘设置有第二锯齿结构23。参见图4，所述固定钉本体10的钉尾2的外缘设置有第一锯齿结构13。所述第一锯齿结构13和第二锯齿结构23相匹配。在固定钉本体10和垫圈20组装时，通过第一锯齿结构13和第二锯齿结构23的匹配连接，可以实现二者的稳定固定。Thewasher 20 is sleeved on the outer side of thenail tail 12 . Referring to FIG. 3 , the inner edge of thewasher 20 is provided with asecond sawtooth structure 23 . Referring to FIG. 4 , the outer edge of the nail tail 2 of thefixing nail body 10 is provided with afirst sawtooth structure 13 . Thefirst sawtooth structure 13 and thesecond sawtooth structure 23 are matched. When thefixing nail body 10 and thewasher 20 are assembled, thefirst sawtooth structure 13 and thesecond sawtooth structure 23 are matched and connected, so that the two can be stably fixed.

所述固定钉本体10为一体式结构，这样的结构固定性更好，且生产工艺更简单。根据对膝关节周围韧带止点的特点的研究，并通过大量的实验数据分析，得到了最优固定钉本体10的一些数值参数。所述固定钉本体10的直径为8.0mm。所述固定钉本体10的长度在2cm～8cm之间，例如：2cm、6cm或8cm。为了在保证实用性的同时降低生产成本，更为优选的，所述固定钉本体10的长度以0.5cm为一个梯度变化，例如：所述固定钉本体10的长度为2cm、2.5cm或7.5cm。Thefixing nail body 10 has a one-piece structure, such a structure has better fixability and simpler production process. According to the research on the characteristics of the insertion point of the ligament around the knee joint, and through the analysis of a large number of experimental data, some numerical parameters of the optimalfixation nail body 10 are obtained. The diameter of thefixing nail body 10 is 8.0 mm. The length of the fixingnail body 10 is between 2 cm and 8 cm, for example: 2 cm, 6 cm or 8 cm. In order to reduce production costs while ensuring practicability, it is more preferable that the length of the fixingnail body 10 is changed in a gradient of 0.5 cm, for example, the length of the fixingnail body 10 is 2 cm, 2.5 cm or 7.5 cm .

本发明提供的固定钉本体10上的螺纹深，固定松质骨把持力好，因此可以进行单皮质固定。此外，也可以与带延长杆的翻修膝关节假体配合使用。The screw thread on the fixingnail body 10 provided by the present invention is deep, and the holding force of the fixed cancellous bone is good, so single cortical fixation can be performed. In addition, it can also be used with revision knee prostheses with extension rods.

优选的，在所述垫圈20上设置有至少一个锥形凸起21。在进行韧带固定时，所述锥形凸起21能够提升固定钉本身的抓持力，不易出现位移，稳定性可得到进一步提升。Preferably, at least oneconical protrusion 21 is provided on thewasher 20 . During ligament fixation, theconical protrusions 21 can improve the gripping force of the fixation nail itself, so that displacement is not easy to occur, and the stability can be further improved.

值得注意的是，所述固定钉本体10是万向螺钉。其与垫圈20之间可以呈一定角度设置。优选的，所述固定钉本体10与所述垫圈20之间的角度在30°范围内，即不超过30°。It is worth noting that the fixingnail body 10 is a universal screw. It and thegasket 20 can be arranged at a certain angle. Preferably, the angle between the fixingnail body 10 and thewasher 20 is within the range of 30°, that is, not more than 30°.

根据损伤的不同，在固定钉固定之外，有时还需要进行走线缝合，以便进一步对损伤部位进行固定，并促进其愈合。为了满足不同的需求，优选的，在所述垫圈20上还设置有穿线孔22，所述穿线孔22用于缝合线走线。由于垫圈20的面积有限，所以穿线孔22的直径不宜过大；但是如果直径过小，可能会导致缝合线走线困难。因此，更为优选的，所述穿线孔22的直径为1.2mm。为了进一步提升缝合的稳定性，优选的，所述穿线孔22至少为两个；且多个穿线孔22之间等间距排布。Depending on the injury, in addition to fixation with staples, sutures are sometimes required to further immobilize the injured site and promote its healing. In order to meet different requirements, preferably, athreading hole 22 is further provided on thewasher 20, and thethreading hole 22 is used for suture routing. Since the area of thegasket 20 is limited, the diameter of thethreading hole 22 should not be too large; however, if the diameter is too small, it may cause difficulty in routing the suture. Therefore, more preferably, the diameter of thethreading hole 22 is 1.2 mm. In order to further improve the stability of stitching, preferably, there are at least two threadingholes 22; and the plurality of threadingholes 22 are arranged at equal intervals.

由于固定钉需要植入体内使用，因此其安全性、稳定性和使用寿命都非常重要。发明人在进行了大量研究之后，采用钛合金材质制备该固定钉，包括固定钉本体10和垫圈20。考虑到骨长入是一个长期的过程，因此，在所述钛合金材质上还涂覆有羟基磷灰石涂层。优选的，所述羟基磷灰石涂层的厚度为50μm。Since the fixation nail needs to be implanted into the body, its safety, stability and service life are all very important. After a lot of research, the inventor uses titanium alloy to prepare the fixing nail, including the fixingnail body 10 and thewasher 20 . Considering that bone ingrowth is a long-term process, the titanium alloy material is also coated with a hydroxyapatite coating. Preferably, the thickness of the hydroxyapatite coating is 50 μm.

以下举例说明本发明提供的固定钉的具体应用过程：当术中内侧副韧带股骨止点撕脱骨折时，首先，用垫圈20(其背面带有锥形凸起21，抓持力更好)将骨折块原位固定；之后，在最合适的方向拧入固定钉本体10(在30度范围内)；最后在穿线孔22中穿入缝合线进行缝合，以加强固定效果。The specific application process of the fixation nail provided by the present invention is illustrated as follows: when the medial collateral ligament femoral insertion is avulsed and fractured during the operation, first, a washer 20 (with a taperedprotrusion 21 on the back side, which has better gripping force) is used. The fracture fragments are fixed in situ; after that, screw thefixation nail body 10 in the most appropriate direction (within a range of 30 degrees); finally, thread the suture in thethreading hole 22 for suture to strengthen the fixation effect.

本发明提供的固定钉，固定效果好，操作简单、成本低，有利于大规模推广使用。The fixing nail provided by the invention has good fixing effect, simple operation and low cost, and is favorable for large-scale popularization and use.

虽然关于示例实施例及其优点已经详细说明，应当理解在不脱离本发明的精神和所附权利要求限定的保护范围的情况下，可以对这些实施例进行各种变化、替换和修改。对于其他例子，本领域的普通技术人员应当容易理解在保持本发明保护范围内的同时，工艺步骤的次序可以变化。Although the exemplary embodiments and their advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made hereto without departing from the spirit of the invention and the scope of protection defined by the appended claims. For other examples, those of ordinary skill in the art will readily understand that the order of the process steps may be varied while remaining within the scope of the present invention.

此外，本发明的应用范围不局限于说明书中描述的特定实施例的工艺、机构、制造、物质组成、手段、方法及步骤。从本发明的公开内容，作为本领域的普通技术人员将容易地理解，对于目前已存在或者以后即将开发出的工艺、机构、制造、物质组成、手段、方法或步骤，其中它们执行与本发明描述的对应实施例大体相同的功能或者获得大体相同的结果，依照本发明可以对它们进行应用。因此，本发明所附权利要求旨在将这些工艺、机构、制造、物质组成、手段、方法或步骤包含在其保护范围内。Furthermore, the scope of application of the present invention is not limited to the process, mechanism, manufacture, composition of matter, means, method and steps of the specific embodiments described in the specification. From the disclosure of the present invention, as those of ordinary skill in the art, it will be easily understood by those of ordinary skill in the art that there are currently existing or will be developed in the future for the process, mechanism, manufacture, composition of matter, means, method or step, wherein they perform the same as the present invention. Corresponding embodiments described that function substantially the same or achieve substantially the same results can be applied in accordance with the present invention. Accordingly, the appended claims of this invention are intended to include within their scope such processes, mechanisms, manufacture, compositions of matter, means, methods, or steps.

Claims (10)

1. A novel knee joint peripheral ligament insertion fixing nail is characterized in that the fixing nail comprises a fixing nail body and a gasket;

the fixing nail body comprises a nail head and a nail tail;

the nail head is a self-tapping nail;

the pad ring is sleeved on the outer side of the nail tail.

2. The fastening nail according to claim 1, wherein the inner edge of the washer and the outer edge of the nail tail are respectively provided with a saw-tooth structure,

the nail tail and the gasket are connected in a matched mode through the sawtooth structure.

3. A staple according to claim 1, in which said washer has at least one tapered projection provided thereon.

4. The staple of claim 1 wherein said washer has threading holes disposed therein for suture routing.

5. The staple of claim 4, wherein said threading aperture has a diameter of 1.2 mm.

6. The staple of claim 1, wherein said staple is fabricated from a titanium alloy material having a hydroxyapatite coating thereon.

7. A staple according to claim 6, in which the hydroxyapatite coating has a thickness of 50 μm.

8. The staple of claim 1, wherein said staple body has a diameter of 8.0 mm.

9. The staple of claim 1, wherein said staple body has a length of between 2cm and 8 cm.

10. The staple of claim 1, wherein said staple body is a unitary structure.

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