CN100450452C - Hybrid interlocking proximal femoral fracture fixation - Google Patents
Hybrid interlocking proximal femoral fracture fixation Download PDFInfo
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- CN100450452C CN100450452C CNB2004800079357A CN200480007935A CN100450452C CN 100450452 C CN100450452 C CN 100450452C CN B2004800079357 A CNB2004800079357 A CN B2004800079357A CN 200480007935 A CN200480007935 A CN 200480007935A CN 100450452 C CN100450452 C CN 100450452C
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Abstract
Description
技术领域 technical field
本发明涉及骨折固定装置。更加具体地,本发明涉及混合联锁式股骨近端骨折固定装置。The present invention relates to fracture fixation devices. More specifically, the present invention relates to a hybrid interlocking proximal femoral fracture fixation device.
背景技术 Background technique
应用钉和板的内固定是一种众所周知的外科手术疗法,该疗法用在整形外科和创伤学方面,以对股骨近端骨折进行固定。该疗法是一种传统式的直视大型外科手术,具有引发严重并发症的若干种可能性。过去认为骨折固定位置的坚固是一种优势,因此,许多现有的内固定装置被构造成在骨折位置能够消除所有的运动(适当的滑动除外)。现在则通常认同在骨折位置上进行某些轻微的运动对骨折更好的愈合、甚至对促进愈合组织的形成至关重要。然而,这个观点并不适用于股骨颈囊内骨折。Internal fixation using nails and plates is a well-known surgical procedure used in orthopedics and traumatology to fix proximal femoral fractures. The procedure is a conventional, direct-view major surgical procedure with several potentials for serious complications. The firmness of the fracture site was considered an advantage in the past, therefore, many existing internal fixation devices are constructed to eliminate all motion (except for proper sliding) at the fracture site. It is now generally accepted that some gentle movement over the fracture site is essential for better fracture healing and even for promoting the formation of healing tissue. However, this view does not apply to intracapsular fractures of the femoral neck.
内固定疗法具有许多缺点,包括手术极其昂贵和复杂,并可并发严重失血和感染。同时不能在手术后进行重新固定,致病率和死亡率也居高不下,并且由于手术的原因,造成住院时间长,这与围术并发症相关。近顶处(囊内)骨折在内固定疗法之后的死亡率惊人:医院内3%,术后一年内25%、两年内40%。在术后局部性和系统性的并发症方面,30%的患者经历过缺血性坏死,43%的患者不愈合以及50%的患者经历过围术。上述数据收集自《临床矫形学与相关研究(Clinical Orthopaedics and RelatedResearch)》(348:22-28,1998及399:119-128,2002)。这些论文作为引用而结合在本文中,而许多其他科学评价刊物中也发表和公布过相似的结果。转子间/转子周围(囊内)骨折的后果也同样令人震惊:15%的患者经历过固定失败,10%一年内死亡、20%两年内死亡,还有20%并发感染,以及30%愈合不良。转子下骨折也发现有相似的结果。Internal fixation has many disadvantages, including an extremely expensive and complicated procedure, which can be complicated by severe blood loss and infection. At the same time, it cannot be refixed after surgery, and the morbidity and mortality are high, and because of the surgery, the hospital stay is long, which is related to perioperative complications. The mortality rate of proximal (intracapsular) fractures following internal fixation is alarming: 3% in the hospital, 25% within one year of surgery, and 40% within two years. In terms of postoperative local and systemic complications, 30% of patients experienced avascular necrosis, 43% of patients experienced nonunion and 50% of patients experienced perioperative. The above data were collected from "Clinical Orthopedics and Related Research" (348:22-28, 1998 and 399:119-128, 2002). These papers are incorporated herein by reference, and similar results have been published and published in many other scientific review journals. The consequences of intertrochanteric/peritchanteric (intratrochanteric) fractures are equally astounding: 15% of patients experience fixation failure, 10% die within one year, 20% die within two years, 20% have concurrent infection, and 30% heal bad. Similar results were found for subtrochanteric fractures.
通过外部设备将钉子及螺钉连接到股骨头、股骨颈以及股骨干上的外固定装置能够对骨折进行固定。该疗法通过微创介入手术得以进行。An external fixation device that attaches nails and screws to the femoral head, neck, and shaft of the femur by external devices fixes the fracture. The therapy is performed through a minimally invasive interventional procedure.
临床证据清楚表明,与传统式内固定疗法比较,通过外固定疗法对转子周围股骨颈骨折进行固定可显著降低死亡率,并且降低严重并发症的发生以及在手术后很快改善骨折后果。外固定疗法还具有其他优点,比如减短住院时间和降低医疗费用、减轻术后骨折处疼痛、便于对患者进行护理、降低被迫卧床的需要以及降低发生褥疮、肺栓塞和肺感染等的可能性。对于股骨转子骨折,外固定是一种安全及可靠的、使骨得到固定的疗法。一般地,外固定疗法增强了多方面适应性,,并且易于操作,使手术时间、出血和组织损伤都降低到最小。Clinical evidence clearly demonstrates that external fixation for peritrochanteric femoral neck fractures significantly reduces mortality compared with traditional internal fixation, reduces the incidence of serious complications, and improves fracture outcomes soon after surgery. External fixation has other advantages, such as shorter hospital stays and medical costs, less postoperative pain at fracture sites, easier patient care, less need for bed rest, and less chance of developing bedsores, pulmonary embolism, and lung infections sex. For trochanteric fractures, external fixation is a safe and reliable therapy to stabilize the bone. In general, external fixation therapy enhances multiple adaptability, and is easy to operate, minimizing operation time, bleeding and tissue damage.
在美国专利No.5,429,641中公开了一种用于骨折后的股骨上部的经皮连接疗法。在美国专利No.5,728,096中公开了另一种外部转子夹板的例子。欧洲专利申请EP 0940124A1中则讲授了一种用于转子骨折的、角度可变的外固定装置。上述作为参照而提到的、以及其他相似的、用以对股骨转子骨折在外部进行固定的装置具有许多缺点,并可引发并发症。由于严重骨质疏松症,而导致股骨颈螺钉刺入髋臼中就是其中的一种危险事故。其他缺点还有硬件故障,装置固定在后侧向凸出位置(lateral posterior bulgingposition)而引起不适,以及患者极其难以采取仰卧位或坐位。In US Patent No. 5,429,641 a percutaneous connection therapy for the fractured upper femur is disclosed. Another example of an outer rotor clamp is disclosed in US Patent No. 5,728,096. European patent application EP 0940124A1 teaches a variable-angle external fixation device for trochanteric fractures. The above mentioned by reference, and other similar devices for external fixation of trochanteric fractures have a number of disadvantages and can lead to complications. Femoral neck screw penetration into the acetabulum due to severe osteoporosis is one such hazard. Other disadvantages include hardware failure, discomfort caused by the device being fixed in a lateral posterior bulging position, and extreme difficulty for the patient in supine or sitting positions.
因此早就存在这么一种需要,即提供一种外部装置,其可消除用以对转子周围骨折进行外部固定的现有装置的严重缺点,所述现有装置是可导致严重并发症的固定装置。There has therefore long been a need to provide an external device that eliminates the serious disadvantages of existing devices for external fixation of peritrochanteric fractures, which are fixation devices that can lead to serious complications .
对于内固定装置,也已开发出特殊设计的螺钉,例如在公开号为WO00/67653的PCT申请中公开了一种螺钉元件,EP 0853923中公开了一种骨髓腔钉子,或美国专利申请2002/0143333中公开了一种固定器。另一种市面有售的固定装置的商业名称为不稳定股骨颈骨折的骨缝合器(双向滑动螺钉),是由Fixano S.A.公司经销,并应用D.S.S.系统。For internal fixation devices, specially designed screws have also been developed, for example a screw element is disclosed in PCT application with publication number WO 00/67653, a intramedullary cavity nail is disclosed in EP 0853923, or US patent application 2002/ A fixator is disclosed in 0143333. Another commercially available fixation device is the Bone Stapler for Unstable Femoral Neck Fractures (Bidirectional Sliding Screw), distributed by the company Fixano S.A., and employs the D.S.S. system.
发明内容 Contents of the invention
本发明的一个目的为提供一种混合联锁式股骨近端骨折固定装置,所述固定装置能进行微创骨折固定。因此,可以使囊外骨折的愈合组织得以提早形成。One object of the present invention is to provide a hybrid interlocking fixation device for proximal femur fractures, which can perform minimally invasive fracture fixation. Therefore, the callus of extracapsular fracture can be formed earlier.
本发明的另一个目的为提供一种股骨颈囊内骨折的内固定装置,其具有连续的滑动加压性能。Another object of the present invention is to provide an internal fixation device for intracapsular fractures of the femoral neck, which has continuous sliding compression performance.
本发明的又一个目的为提供一种混合联锁式股骨近端骨折固定装置,其将一种独特的新式内部钉子与一种非刚性固定器组合在一起,用以囊外骨折治疗。Another object of the present invention is to provide a hybrid interlocking proximal femoral fracture fixation device, which combines a unique new internal nail with a non-rigid fixator for extracapsular fracture treatment.
本发明的再一个目的为提供一种固定技术,其易于应用,适合时间短的小型手术。Yet another object of the present invention is to provide a fixation technique that is easy to apply and suitable for minor operations with a short time.
因此,依据本发明的一个方面,提供了一种用以固定股骨颈囊内骨折的内固定装置,包含:Therefore, according to one aspect of the present invention, an internal fixation device for fixing intracapsular fractures of the femoral neck is provided, comprising:
具有尖端和钝端的管件;pipe fittings with pointed and blunt ends;
在所述管件中具有至少一个通道,其中所述至少一个的通道从所述尖端延伸到所述钝端;having at least one channel in said tubing, wherein said at least one channel extends from said tip to said blunt end;
至少一个螺钉,其适于穿过所述至少一个的通道,并适于越过所述尖端向外延伸;at least one screw adapted to pass through said at least one channel and adapted to extend outwardly beyond said tip;
在适于越过所述尖端并延伸的所述至少一个的螺钉的一部分上带有螺纹;having threads on a portion of said at least one screw adapted to extend beyond said tip;
所述至少一个的螺钉具有螺钉头,从而防止所述至少一个的螺钉全部插入到所述至少一个的通道中;said at least one screw has a screw head, thereby preventing said at least one screw from being fully inserted into said at least one channel;
由此,在所述管件移植到骨中、越过骨折线大约1或2毫米之后,所述至少一个的螺钉插入到所述至少一个的通道中,从而维持骨块的压力,以利于愈合。Thus, after the tube is implanted into the bone approximately 1 or 2 mm past the fracture line, the at least one screw is inserted into the at least one channel to maintain pressure on the bone fragment for healing.
此外,依据本发明另一个优选实施例,所述管件为中空管子。In addition, according to another preferred embodiment of the present invention, the pipe is a hollow pipe.
此外,依据本发明另一个优选实施例,所述中空管子具有一个轮廓,比如圆形、椭圆形、三角形或矩形。Furthermore, according to another preferred embodiment of the present invention, said hollow tube has a contour, such as circular, elliptical, triangular or rectangular.
此外,依据本发明另一个优选实施例,所述中空管子具有孔洞。Furthermore, according to another preferred embodiment of the present invention, the hollow tube has holes.
此外,依据本发明另一个优选实施例,所述中空管子可填上促进骨愈合的骨移植材料。In addition, according to another preferred embodiment of the present invention, the hollow tube can be filled with a bone graft material that promotes bone healing.
此外,依据本发明另一个优选实施例,与所述至少一个的螺钉组合在一起的所述管件可进行加压和滑行运动。In addition, according to another preferred embodiment of the present invention, the pipe member combined with the at least one screw can perform pressing and sliding motions.
此外,依据本发明另一个优选实施例,具有三个方头螺钉,以对应于所述管件上所具有的三个通道。Furthermore, according to another preferred embodiment of the present invention, there are three lag screws corresponding to the three passages on the pipe.
此外,依据本发明另一个优选实施例,所述管件以相对于股骨干轴线大约95-110度的角度,插入到股骨颈中,从而使所述三个方头螺钉中的下螺钉定位于股骨头的下象限(inferor quadrant)方向,以使所述下螺钉稍微接触到股骨颈上股骨距的坚质皮层骨。Furthermore, according to another preferred embodiment of the present invention, said tubular member is inserted into the femoral neck at an angle of approximately 95-110 degrees relative to the axis of the femoral shaft, thereby positioning the lower of said three lag screws in the femoral neck. Orient the inferior quadrant of the bone so that the inferior screw touches the firm cortical bone of the femoral calcar on the femoral neck slightly.
此外,依据本发明另一个优选实施例,所述三个螺钉适于穿刺股骨头的下象限,优选为圆韧带血管分布的远处。In addition, according to another preferred embodiment of the present invention, the three screws are suitable for piercing the lower quadrant of the femoral head, preferably the distal part of the vascular distribution of the round ligament.
此外,依据本发明另一个优选实施例,其中所述管件装有骨替代物,以使骨移植到所述管件中。Furthermore, according to another preferred embodiment of the present invention, wherein the tubular member is equipped with a bone substitute so that bone is grafted into the tubular member.
此外,依据本发明另一个优选实施例,所述固定装置进一步与外固定器联锁。In addition, according to another preferred embodiment of the present invention, the fixation device is further interlocked with an external fixator.
此外,依据本发明的另一个方面,提供了一种用以固定股骨颈或转子周围区域骨折的混合联锁式固定装置,包含:In addition, according to another aspect of the present invention, a hybrid interlocking fixation device for fixing fractures of the femoral neck or the area around the trochanter is provided, comprising:
具有尖端和钝端的管件;pipe fittings with pointed and blunt ends;
在所述管件中具有至少一个通道,其中所述至少一个的通道从所述尖端延伸到所述钝端;having at least one channel in said tubing, wherein said at least one channel extends from said tip to said blunt end;
至少一个螺钉,其适于穿过所述至少一个的通道,并适于越过所述尖端向外延伸;at least one screw adapted to pass through said at least one channel and adapted to extend outwardly beyond said tip;
至少两个钻孔,其位于所述管件的侧部,其中所述至少两个的钻孔位于所述管件相对的两侧上;at least two boreholes located on the sides of the pipe, wherein the at least two boreholes are located on opposite sides of the pipe;
至少四个销钉,其中至少两个销钉适于在所述管件和所述至少两个的销钉之间互锁,并且至少两个销钉钉入到远端骨块中,以确保管件固定在骨中;at least four pins, at least two of which are adapted to interlock between the tube and the at least two pins, and at least two of which are driven into the distal bone fragment to ensure that the tube is fixed in the bone ;
一个连接元件,用于确保与所述至少两个的销钉紧固在一起;a connecting element for securing fastening with said at least two pins;
由此,所述管件移植在股骨颈中,所述至少一个的螺钉插入所述至少一个的通道中并从其穿过,从而得以维持断裂块的压力和滑动,至少一个销钉钉入到所述管件中,穿过所述至少两个的钻孔,同时至少两个销钉钉入到所述远端骨块中,其中所述销钉通过所述连接元件互相连接,以利于骨愈合,并且可在手术后对所述连接元件的连接进行矫正。Thus, the tube is implanted in the femoral neck, the at least one screw is inserted into and passes through the at least one channel, thereby maintaining the pressure and sliding of the fracture block, and at least one pin is driven into the In the tube, through the at least two drill holes, at least two pins are driven into the distal bone fragment at the same time, wherein the pins are connected to each other through the connecting element, so as to facilitate bone healing, and can be used in The connection of the connecting elements is corrected post-operatively.
此外,依据本发明另一个优选实施例,所述管件具有三个通道。Furthermore, according to another preferred embodiment of the present invention, the pipe has three channels.
此外,依据本发明另一个优选实施例,具有三个穿过所述三个通道的螺钉。Furthermore, according to another preferred embodiment of the present invention, there are three screws passing through said three channels.
此外,依据本发明另一个优选实施例,所述管子上具有六个钻孔,其中所述六个钻孔以这样的方式设置,使得六个钻孔的其中三个位于所述六个钻孔中的另外三个的对面,并且三个销钉适于从所述管件的一侧到另一侧插入到所述六个钻孔中。Furthermore, according to another preferred embodiment of the present invention, the pipe has six boreholes, wherein the six boreholes are arranged in such a way that three of the six boreholes are located in the six boreholes Opposite the other three of the pipes, and three pins are adapted to be inserted into the six bores from one side of the pipe to the other.
此外,依据本发明另一个优选实施例,所述连接元件包含两个夹紧器和螺杆,其中一个夹紧器夹紧钉入到远端骨块中的销钉,而第二个夹紧器则夹紧旋入到所述管件中的销钉。In addition, according to another preferred embodiment of the present invention, the connecting element comprises two clamps and a screw rod, wherein one clamp clamps the pin driven into the distal bone fragment, and the second clamp Clamp the pin screwed into the pipe.
此外,依据本发明另一个优选实施例,所述一个夹紧器和所述第二夹紧器之间的距离可通过旋转所述旋转螺杆而改变,其中所述螺杆通过两个具有球形头的螺栓而连接到每一个夹紧器上,其中所述旋转螺杆旋入到所述两个螺栓上。Furthermore, according to another preferred embodiment of the present invention, the distance between the one clamper and the second clamper can be changed by rotating the rotating screw, wherein the screw is passed through two ball-headed Bolts are connected to each clamp, wherein the rotary screw is threaded onto the two bolts.
此外,依据本发明另一个优选实施例,可在术中和术后阶段对混合联锁式固定装置的错位进行矫正。Furthermore, according to another preferred embodiment of the present invention, the misalignment of the hybrid interlocking fixation device can be corrected during the intraoperative and postoperative stages.
此外,依据本发明另一个优选实施例,所述管件具有多个小壁孔。In addition, according to another preferred embodiment of the present invention, the pipe has a plurality of small wall holes.
此外,依据本发明另一个优选实施例,所述装置具有射线可透过材料或其它材料。Furthermore, according to another preferred embodiment of the present invention, the device has a radiolucent or other material.
此外,依据本发明另一个优选实施例,所述装置可具有抛弃性。Furthermore, according to another preferred embodiment of the present invention, the device may be disposable.
此外,依据本发明另一个优选实施例,所述管件具有骨替代物,使骨能够移植到所述管件中。Furthermore, according to another preferred embodiment of the present invention, the tubular member has a bone substitute, enabling bone to be grafted into the tubular member.
依据本发明的又一个方面,提供了一种固定股骨颈囊内骨折的方法,所述方法包含:According to still another aspect of the present invention, a kind of method for fixing intracapsular fracture of femoral neck is provided, and described method comprises:
提供一种内固定器,其包含:An internal fixator is provided, comprising:
具有尖端和钝端的管件;pipe fittings with pointed and blunt ends;
在所述管件中具有至少一个通道,其中所述至少一个的通道从所述尖端延伸到所述钝端;having at least one channel in said tubing, wherein said at least one channel extends from said tip to said blunt end;
至少一个螺钉,其适于穿过所述至少一个的通道,并适于越过所述尖端向外延伸;at least one screw adapted to pass through said at least one channel and adapted to extend outwardly beyond said tip;
在适于越过所述尖端并延伸的所述至少一个的螺钉的一部分上带有螺纹;having threads on a portion of said at least one screw adapted to extend beyond said tip;
所述至少一个的螺钉具有一个螺钉头,从而防止所述至少一个的螺钉全部插入到所述至少一个的通道中;said at least one screw has a screw head, thereby preventing said at least one screw from being fully inserted into said at least one channel;
在转子区域切开2-3厘米长的皮肤切口;Make a 2-3 cm long skin incision in the trochanteric area;
以相对于股骨干骨轴线大约95-110度的角度将所述管件插入到股骨颈中,使所述至少一个的方头螺钉的其中一个下螺钉能被定位于股骨头的下象限方向,从而使所述下螺钉稍微接触到股骨距的坚质皮层骨,其中所述管件越过骨折线大约1或2毫米;inserting the tube into the femoral neck at an angle of about 95-110 degrees relative to the axis of the femoral shaft such that one of the lower screws of the at least one lag screw can be positioned in the lower quadrant of the femoral head, thereby Bring the lower screw into light contact with the solid cortical bone of the calcar, with the tube about 1 or 2 millimeters beyond the fracture line;
旋入所述至少一个的方头螺钉。Screw in the at least one lag screw.
此外,依据本发明另一个优选实施例,所述方法进一步包含:In addition, according to another preferred embodiment of the present invention, the method further includes:
提供至少两个钻孔,其位于所述管件上,其中所述至少两个的钻孔位于所述管件相对的两侧上;providing at least two boreholes on said tubular member, wherein said at least two boreholes are located on opposite sides of said tubular member;
将至少两个销钉在所述至少两个的钻孔中联锁;interlocking at least two pins in said at least two bore holes;
将至少两个销钉钉入到远端骨块中;driving at least two pins into the distal bone fragment;
提供一个连接元件,其适于将所述销钉紧固在一起。A connecting element is provided which is adapted to fasten the pins together.
另外,依据本发明另一个优选实施例,所述方法进一步包含术中和术后阶段所进行的矫正、复位和固定。In addition, according to another preferred embodiment of the present invention, the method further includes correction, reduction and fixation in the intraoperative and postoperative stages.
附图的简单说明A brief description of the drawings
为了更好地理解本发明以及领会本发明的实际应用,在本文提供了以下附图,并对所述附图进行了参考。相同部件由相同的附图标号表示。In order to better understand the invention and appreciate its practical application, the following drawings are provided herein and reference is made to said drawings. The same components are denoted by the same reference numerals.
应该注意,所给出的附图仅作为例子和优选实施方式而已,并未限制说明部分和权利要求书中所限定的范围。It should be noted that the given drawings are only examples and preferred embodiments, and do not limit the scope defined in the description and claims.
附图1显示了依据本发明的其中一个优选实施例的混合联锁式股骨近端骨折固定装置的等距视图,图中显示出所述装置定位于股骨上的情形;Accompanying drawing 1 shows an isometric view of a hybrid interlocking proximal femoral fracture fixation device according to one of the preferred embodiments of the present invention, showing that the device is positioned on the femur;
附图2a-c显示了依据本发明的其中一个优选实施例的钉盒植入装置的视图;Figures 2a-c show views of a staple cartridge implantation device according to a preferred embodiment of the present invention;
附图3显示了依据本发明的另一个优选实施例的钉盒植入装置的等距视图;Accompanying drawing 3 has shown the isometric view of the staple cartridge implantation device according to another preferred embodiment of the present invention;
附图4为依据本发明的其中一个优选实施例的连接元件的等距视图,其中所述连接元件连接外固定装置;Figure 4 is an isometric view of a connecting element according to one of the preferred embodiments of the present invention, wherein said connecting element is connected to an external fixation device;
附图5显示了如附图1中所示的混合联锁式股骨近端骨折固定装置的部件分解视图;Accompanying drawing 5 has shown the parts exploded view of hybrid interlocking type proximal femur fracture fixation device as shown in accompanying drawing 1;
附图6显示了依据本发明的其中一个优选实施例的、在内固定疗法中被固定住的钉盒植入装置的等距视图。Figure 6 shows an isometric view of a staple cartridge implant secured during internal fixation therapy, in accordance with one of the preferred embodiments of the present invention.
发明具体实施方式Specific Embodiments of the Invention
本发明提供了一种独特的新式股骨骨折固定装置,其包含一个内固定器和一个外固定器。用以股骨颈部囊内骨折的内固定器大体上包含一个具有一个尖端(sharp end)和一个钝端(blunt end)的管件。所述管件可为中空元件或实心元件。在管件中提供至少一个从尖端延伸到钝端的通道,其中所述通道适于容纳方头螺钉。所述螺钉适于越过所述尖端向外伸出,并适于伸入到骨中,从而维持骨折处的固定压力,以利于愈合,因此,螺钉越过尖端伸出的部分带有螺纹。优选为具有三个通道和相应的方头螺钉。在本文中,管件也可称作钉盒。所述钉盒和方头螺钉可“单独”使用,作为一种用于囊内股骨颈骨折的新颖及独特的内固定器,或以及作为传统空心螺钉的替代品,可以植骨于所述钉盒中。所述钉盒和方头螺钉主要用于Garden I、II、III型的下型股骨骨折(subcapital femoral fractures)。The invention provides a unique new fixation device for femur fracture, which comprises an internal fixator and an external fixator. Internal fixators for intracapsular fractures of the femoral neck generally consist of a tube with a sharp end and a blunt end. The tubing can be a hollow element or a solid element. At least one channel is provided in the tubular member extending from the tip to the blunt end, wherein the channel is adapted to receive a lag screw. The screw is adapted to protrude outwardly beyond the tip and to penetrate into the bone so as to maintain a fixation pressure at the fracture to facilitate healing, and therefore, the portion of the screw protruding beyond the tip is threaded. Preferably there are three channels and corresponding lag screws. A tube may also be referred to herein as a staple box. The cartridge and lag screw can be used "alone" as a novel and unique internal fixator for intracapsular femoral neck fractures, or as an alternative to traditional cannulated screws to which bone can be grafted in the box. The nail box and lag screws are mainly used for subcapital femoral fractures of Garden I, II, and III types.
在微创手术中将钉盒插入骨中。优选地,所述钉盒通过一个2-3厘米长的皮肤切口插入。固定器的外部部件适于在不进行麻醉的情况下、在后续的门诊诊疗中拆除。优选地,所述装置的外部部件由可随意处置的钛或其它射线可通过的材料制成,其中所述射线可通过的透射材料比如经FDA(美国食品及药物管理局)批准的铝70。The staple cartridge is inserted into the bone in a minimally invasive procedure. Preferably, the staple cartridge is inserted through a 2-3 cm long skin incision. The outer part of the retainer is adapted to be removed at a subsequent outpatient visit without anesthesia. Preferably, the external parts of the device are made of disposable titanium or other radiolucent material, such as FDA (US Food and Drug Administration) approved aluminum 70.
现参看附图1,图中显示了依据本发明的其中一个优选实施例的混合联锁式股骨近端骨折固定装置的等距视图,显示出所述装置定位于股骨上的情形。遭受严重损伤的股骨(尤其是股骨颈)很难固定。总体上,本发明的骨折固定装置为带有联锁系统的内和外固定装置的组合体,其中所述联锁系统通过一个标准化固定器将断裂的上部断块连接到股骨干上。一旦由于偏移、压缩、旋转、成角(angulation)或平移而引起内翻或外翻畸形、旋转及成角部分缩短的情形(rotation angulation shortening),则可使用本发明进行术后的定位矫正。造成错位的原因有可能与手术技术不高以及骨质量差有关。Referring now to FIG. 1 , there is shown an isometric view of a hybrid interlocking proximal femoral fracture fixation device according to one preferred embodiment of the present invention, showing the device positioned on the femur. A severely injured femur (especially the femoral neck) is difficult to immobilize. In general, the fracture fixation device of the present invention is a combination of internal and external fixation devices with an interlocking system that connects the fractured upper segment to the femoral shaft via a standardized fixator. In case of varus or valgus deformity, rotation and angulation shortening due to offset, compression, rotation, angulation or translation, the present invention can be used for postoperative positioning correction . The cause of dislocation may be related to poor surgical technique and poor bone quality.
混合式装置10包含一个钉盒12,其适于被移植在股骨颈14之中。优选地,钉盒12为一个具有一个尖端16和一个钝端18的中空管件。备选地,所述元件可以为非中空的实心结构。钉盒12中的中空使得可经螺钉的中心孔进行导液,从而减轻由于骨折出血而引起的高压型囊内积血。导液可降低对现存脆弱的血管供应的损害,因而减少了造成股骨头缺血性坏死的常见原因中的其中一个。插入钉盒12,并使其越过骨折线大约1-2毫米,以使骨植入带有自体移植物、异体移植物或其它骨替代物的盒子中。The
优选地,三个压紧螺钉20(方头螺钉)适于穿过钉盒12(从钉盒钝端18到钉盒尖端16),从而所述螺钉可最近地穿过所述尖端延伸,并且旋入到骨之中。螺钉越过钉盒12延伸使得穿刺到股骨头中的金属体积减到最小,即只使用三个方头螺钉就可达到软骨下骨组织。金属穿刺体积的最小化防止或避免了对股骨头上血管供应的进一步损害。每一个压紧螺钉20具有一个螺钉头22,其防止螺钉全部移动到钉盒12中。压紧螺钉20用来对骨折处进行加压,使愈合加快。钉盒与压紧螺钉结合在一起适于进行滑动以及加压。从钉子的钝端18以及螺钉头处加压,将位于侧部的转子皮层骨固定在钉盒钝端的周围。压紧螺钉20的延伸部分带有螺纹24,从而利于加压过程的进行。由于钉子独特的结构,钉盒12和压紧螺钉20能够引入骨片、并使其嫁接到骨折线上。在钉盒为中空的情况下,可在钉盒12的内部填上骨嫁接材料,以促进骨的快速愈合。Preferably, three compression screws 20 (lag screws) are adapted to pass through the cartridge 12 (from the
通过微创手术将钉盒12插入到股骨颈中。钉盒和螺钉穿刺的最佳角度为相对于股骨轴线100到110度之间。由此,能够以这样的方式定位压紧螺钉20的下螺钉,使得所述压紧螺钉20的下螺钉稍微地接触到股骨距(calcar femori)的坚质皮层骨(strong cortical bone)。所有三个压紧螺钉20只穿透股骨头的下半部,优选为圆韧带血管分布的远处,这就避免了对骨内网状血液循环的损害,并进一步减少了缺血性坏死的可能性。The
外固定器100连接钉盒12和远端骨块102。优选地,外固定器100包含6个销钉,其中三个销钉104钉入钉盒12中,而另外三个销钉106则钉入远端骨块102中。所有六个销钉,即104和106,通过一个连接元件108互相连接,其中所述连接元件108包含一个夹紧销钉104的上夹紧器110和一个夹紧销钉106的下夹紧器112。优选地,连接元件108进一步包含两个旋转螺杆114,其连接上夹紧器110和下夹紧器112。旋转螺杆114长度可变,并且能够以这样的方式连接所述夹紧器,使得所述夹紧器相互之间具有一定的定位自由度。以下将对这方面进行详尽描述。The
现参看附图2a-c,图中显示了依据本发明的其中一个优选实施例的钉盒植入装置的视图。所述钉盒植入装置适于结合在本发明的混合联锁式固定装置中。钉盒12为一个具有三角形截面的中空管件,其具有尖端16、钝端18以及一个穿过钉子的空孔55。钉盒12适于插入股骨颈中,即通过其尖端18将钉盒12推入骨中。优选地,钉盒12由不会引起排斥的材料(比如钛)制成。在植骨的情形下,钉盒可留在原处,或在骨愈合之后将钉盒取出。同时,钉盒以及从其内穿过的压紧螺钉还可由生物降解材料制成。Referring now to Figures 2a-c, there are shown views of a cartridge implantation device according to one of the preferred embodiments of the present invention. The staple cartridge implantation device is suitable for incorporation in the hybrid interlocking fixation device of the present invention. The
为了能够接触和使骨与嫁接材料一同生长,优选钉盒12的壁上具有多个相对较小的孔口54,以使骨可长入到钉盒12中。备选地,将自体嫁接骨或成骨传导/诱导材料引入钉盒12中(图中未显示),以促进骨的生长。In order to allow access and growth of bone with the grafting material, it is preferred that the walls of the
钉盒12具有通道,优选为具有三个通道56,其穿过管壁,并从尖端16延伸到钝端18。通道56在尖端和钝端均具有开口,通过所述开口,可在钉盒12移植后将压紧方头螺钉20(如附图1所示)旋入。本发明的钉盒在与所述三个方头螺钉一同使用时,具有加压性和滑动性。The
现参看附图6,图中显示了依据本发明的其中一个优选实施例的、在内固定疗法中被固定住的钉盒植入装置的等距视图。钉盒12移植在股骨中,同时三个方头螺钉20被联锁在钉盒12中。Referring now to FIG. 6, there is shown an isometric view of a staple cartridge implant secured during an internal fixation therapy in accordance with a preferred embodiment of the present invention. The
回看附图2,进一步地,钉盒12具有钻孔,优选为六个钻孔,其中三个钻孔58成排位于所述管的一侧上,而另三个钻孔(图中看不到)则位于与三个钻孔58相对的一排上。相对的两排钻孔相互偏移错开,例如一排更接近钝端18,而三个钻孔58更接近尖端16。所有钻孔均具有外螺纹,以使适配的螺钉能够旋入到其内。所述钻孔适于容纳外固定装置的三个销钉104(如附图1所示),所述三个销钉104从一侧到另一侧被旋入所述钻孔中,同时维持钉盒和销钉之间的预定角度。Looking back at accompanying drawing 2, further,
现参看附图3,图中显示了依据本发明的另一个优选实施例的钉盒植入装置的等距视图。钉盒200为一个具有圆形截面的中空管件。与先前显示在本文中的钉盒相似,钉盒200具有一个适于推入到骨中的尖端16和一个钝端18。优选地,三个通道56适于容纳方头螺钉(所述螺钉图中未显示)。Referring now to Figure 3, there is shown an isometric view of a cartridge implantation device in accordance with another preferred embodiment of the present invention. The
现回看附图1,图中清楚地显示了三个压紧螺钉20插入到通道56中,而三个销钉104则插入到六个侧部钻孔中。如上所述,销钉104与销钉106互相连接,其中所述销钉106钉入到远端骨块102中。销钉104与钉盒12的连接角度使得可将外固定装置引向前侧方。由此,外固定装置突出到患者大腿的前侧远部,不会影响到患者的髋部屈曲或仰卧位。Referring now to Figure 1, it is clearly shown that the three
关键的一点为应该注意到的是,如附图6所示,也可在不使用外固定装置的情况下使用压紧方头螺钉将所述钉盒植入,以在股骨颈中进行骨折固定。A key point to note is that the cartridge can also be implanted using compression lag screws without the use of external fixation devices for fracture fixation in the femoral neck as shown in Figure 6 .
现参看附图4,图中所示为依据本发明的其中一个优选实施例的连接元件的等距视图,其中所述连接元件连接到外固定装置。连接元件为本发明外固定装置的一部分。连接元件108适于在外部固定和支撑钉盒,其中所述钉盒植入股骨颈中。连接元件108被设计成可进行手术中矫正以及手术后矫正。因此,连接元件108包含一个夹紧销钉104的上夹紧器110以及一个夹紧销钉106的下夹紧器112(附图4中未显示所述销钉)。优选地,连接元件108进一步包含两个旋转螺杆114,其连接上夹紧器110和下夹紧器112。Referring now to Fig. 4, there is shown an isometric view of a connecting element according to one of the preferred embodiments of the present invention, wherein the connecting element is connected to an external fixation device. The connecting element is part of the external fixation device of the present invention. Connecting
上夹紧器110具有三个钻孔150,所述钻孔150适于销钉104从其内穿过。销钉104通过三个阿伦螺钉152被固定在钻孔150中(附图4中未显示所述销钉)。通过相似的方式,下夹紧器112的其中一部分上也具有三个钻孔154,可将销钉106(图中未显示)插入所述三个钻孔154内,并可通过三个阿伦螺钉156将所述销钉106固定住。The
优选地,连接上夹紧器110和下夹紧器112的旋转螺杆114为管子,其带有内螺纹以及优选地还具有六角形辅助件158,其中所述六角形辅助件158便于旋转螺杆114的旋转,从而便于调整上夹紧器110和下夹紧器112之间的距离和角度。旋转螺杆114具有螺栓160,其被旋入到所述管子之内,穿入所述管子的所有四个开口。每一个螺栓160具有一个球形头162,其中所述球形头162被牢固地夹持在相应的夹紧器中。当所述螺栓头被夹持在夹紧器中时,旋转螺杆114可绕着其长度方向的轴线旋转而改变两个夹紧器之间的距离,从而能够在手术后改变外固定装置的方位。每一个螺栓头162被夹持在夹紧器的一个凹座中,其中所述凹座适于通过阿伦螺钉164紧压到所述螺栓头上。当想要改变旋转螺杆114相对于所述夹紧器的角度时,医生可松开阿伦螺钉164,使球形头在夹紧器凹座中旋转即可。转到合适位置时,医生再将阿伦螺钉164旋紧。关键的一点为应该注意到本发明的装置所使用的部件极少,从而便于外科医生进行操作。Preferably, the
现参看附图5,图中显示了如附图1中所示的混合联锁式股骨近端骨折固定装置的部件分解视图。图中清楚地显示了构成本发明装置的部件的数量极少但很有效。钉盒12适于移植在股骨颈中,以及适于容纳压紧螺钉20。在某些情况下,有内固定装置就已足够,而不再需要外固定装置。在需要外固定装置的情况下,销钉104插入到钉盒12中,而销钉106则钉入到远端骨块中。销钉通过连接元件互相连接,其中所述连接元件包含夹紧器110和112以及旋转螺杆114。本发明的连接元件的其中一个重要特征在于其只通过阿伦螺钉即具有转动性、以及其旋转螺杆的长度可改变。Referring now to FIG. 5 , there is shown an exploded view of the hybrid interlocking proximal femoral fracture fixation device shown in FIG. 1 . The figure clearly shows the minimal but effective number of components that make up the device of the invention.
本发明的装置用于囊内及囊外股骨骨折(包括股骨转子下骨折)。The device of the invention is used for intracapsular and extracapsular femoral fractures (including subtrochanteric fractures).
本发明的混合联锁式固定装置的其中一个重要特征在于本发明的疗法为微创手术器械的应用,其主要通过销钉进行重复的组织穿刺。该事实使得便于利用机器人技术,以使手术过程能以快速、准确以及受控的方式进行。One of the important features of the hybrid interlocking fixation device of the present invention is that the therapy of the present invention is the application of minimally invasive surgical instruments, which mainly perform repeated tissue punctures through pins. This fact facilitates the use of robotics so that surgical procedures can be performed in a fast, accurate and controlled manner.
所述混合联锁式固定装置的外部件适于在后续的门诊诊疗中,在不进行麻醉的情况下拆除。内部的钉盒和螺钉可留在原处。钉盒和螺钉可由生物可吸收材料制成,其在一段时间后可被吸收。The outer parts of the hybrid interlocking fixation device are adapted to be removed without anesthesia in a subsequent outpatient visit. The nail box and screws inside stay in place. Nail boxes and screws can be made of bioabsorbable material, which absorbs over time.
插入体中的固定器的部件可由射线可透过材料制成,从而利于在骨愈合过程中进行后续的x光拍片。Components of the anchor in the insert can be made of radiolucent material to facilitate subsequent x-rays during bone healing.
备选地,本发明的装置可装配抛弃性部件,以降低成本。Alternatively, the device of the present invention may be assembled with disposable components to reduce costs.
应该清楚理解在说明书中所进行的实施例和附图的描述只是起到有助于更好理解本发明的作用,而非限制权利要求书中所涵盖的范围。It should be clearly understood that the descriptions of the embodiments and the accompanying drawings in the specification are only for helping to better understand the present invention, rather than limiting the scope covered in the claims.
还应清楚理解本领域的技术人员在通读本发明的说明书后,可对上述附图和实施例进行涵盖在权利要求书中的调整和更改。It should also be clearly understood that those skilled in the art may make adjustments and changes covered in the claims to the above-mentioned drawings and embodiments after thoroughly reading the description of the present invention.
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Citations (4)
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US5569251A (en) * | 1993-07-16 | 1996-10-29 | Bhc Engineering, L.P. | Implant device and method of installing |
CN2253640Y (en) * | 1995-12-21 | 1997-05-07 | 南汇县中心医院 | Femoral rotator connected intrabony fixator |
CN1171231A (en) * | 1997-06-25 | 1998-01-28 | 王群波 | Appliance for femur neck type intramedullary fixation |
WO2002034148A2 (en) * | 2000-10-25 | 2002-05-02 | Kyphon Inc. | Systems and methods for reducing fractured bone using a fracture reduction cannula |
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Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5569251A (en) * | 1993-07-16 | 1996-10-29 | Bhc Engineering, L.P. | Implant device and method of installing |
CN2253640Y (en) * | 1995-12-21 | 1997-05-07 | 南汇县中心医院 | Femoral rotator connected intrabony fixator |
CN1171231A (en) * | 1997-06-25 | 1998-01-28 | 王群波 | Appliance for femur neck type intramedullary fixation |
WO2002034148A2 (en) * | 2000-10-25 | 2002-05-02 | Kyphon Inc. | Systems and methods for reducing fractured bone using a fracture reduction cannula |
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