WO2018006428A1 - 骶骨修复体 - Google Patents

骶骨修复体 Download PDF

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Publication number
WO2018006428A1
WO2018006428A1 PCT/CN2016/089486 CN2016089486W WO2018006428A1 WO 2018006428 A1 WO2018006428 A1 WO 2018006428A1 CN 2016089486 W CN2016089486 W CN 2016089486W WO 2018006428 A1 WO2018006428 A1 WO 2018006428A1
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WO
WIPO (PCT)
Prior art keywords
prosthesis
rod
repair
screw
nail
Prior art date
Application number
PCT/CN2016/089486
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English (en)
French (fr)
Inventor
郭卫
王彩梅
姬涛
Original Assignee
北京爱康宜诚医疗器材有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 北京爱康宜诚医疗器材有限公司 filed Critical 北京爱康宜诚医疗器材有限公司
Priority to US16/315,925 priority Critical patent/US10751188B2/en
Priority to EP16907932.4A priority patent/EP3482719B1/en
Priority to PCT/CN2016/089486 priority patent/WO2018006428A1/zh
Publication of WO2018006428A1 publication Critical patent/WO2018006428A1/zh

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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002—Longitudinal elements, e.g. rods
    • A61B17/7011—Longitudinal element being non-straight, e.g. curved, angled or branched
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Definitions

  • the present invention relates to the field of medical devices, and in particular to a tibial prosthesis.
  • the humerus is an important bony structure connecting the human trunk to the limb.
  • the upper part and the lumbar vertebrae form the lumbosacral joint, and the pelvis forms ankle joint on both sides. Since the inside of the tibia is not only important for the phrenic nerve, but also the ankle joint is the only structure that connects the central and lower limb bones. Therefore, this part of the surgical resection has a greater impact on neurological function and structural stability.
  • radiotherapy, chemotherapy and tumor resection are the preferred options for most sacral tumors. However, due to the early symptoms of sacral tumors, the sacral tumors have a large number of features.
  • patella resection is a major difficulty in the international bone oncology community. At present, a variety of sacral tumor resection and reconstruction operations have occurred, and the most common surgical method is structural bone graft reconstruction.
  • Structural bone graft reconstruction is mainly divided into two categories: one is “church-type” reconstruction, that is, the lower lumbar vertebrae are directly supported on the tibia by the humeral nail and the nail rod system; although the above-mentioned structural bone graft reconstruction can achieve the bearing capacity in the short term The effect, but from the long-term follow-up observation, the nail rod is prone to breakage or loosening, the bone is damaged, the patient will once again fall into a state in which he can't stand and walk, and he can't take care of himself. He must perform a fixed operation again.
  • Another type of structural bone graft reconstruction is reconstruction through the tibial rod, that is, connecting the bilateral tibia through the bone graft or the inner plant, restoring the posterior pelvic ring, and through the nail rod system and the lateral metal rod or bone graft structure. Connect and reconstruct the stress transmission from the lumbar spine to the tibia.
  • the early stability of structural bone graft reconstruction described above requires the provision of intrametallic plants, but long-term stability requires bony fusion, so bioreconstruction is critical for long-term lumbosacral stability. From a biomechanical point of view, because the lumbar pelvis is fixed after a long torque, this causes the lumbosacral region to withstand high stress and shear force.
  • the above reconstruction method can not achieve complete fusion of the lumbar pelvis, resulting in stress mainly concentrated in the metal. Inner plant. In the long run, it will lead to fatigue fracture of the plants in the metal, which will cause the plants in the metal to lose their fixation effect and passively pull out. Although the extraction of plants in the metal can be reduced by applying bone grafting, hydroxyapatite, bone cement, long screws, etc., the problem of fatigue fracture of the plants in the metal is not solved, and it is difficult to achieve effective reconstruction.
  • the present invention aims to provide a humeral prosthesis to solve the problem that the support of the nail rod system in the prior art is unreliable and easily fatigue fracture.
  • the present invention provides a tibial prosthesis comprising: a prosthetic body comprising two first prostheses and a second prosthesis connected between the two first prostheses, each first restoration First and second ends of the body
  • the prosthesis is connected, the two first prosthesis and the second prosthesis are integrally formed, and the second end of each first prosthesis extends in a direction away from the second prosthesis and is in contact with the tibia, the second prosthesis
  • the top is in contact with the lumbar vertebral body; the nail rod structure, the nail rod structure package connecting seat and the rod body, the connecting seat is connected with the repairing body, and the rod body is fixed on the connecting seat.
  • the first restoration body is provided with a first screw hole, the first screw hole is a tapered hole, the first screw hole is provided with a first nail seat, the first nail seat has a spherical inner surface, and/or the second repair
  • the second screw hole is disposed on the body, the second screw hole is a tapered hole, the second screw hole is provided with a second nail seat, and the second nail seat has a spherical inner surface.
  • the connecting seat comprises: a connecting screw, one end of the connecting screw is connected with the repairing body, the other end of the connecting screw has a spherical nail head; the rod fixing portion is used for fixing the rod body, and one end of the rod fixing portion has a spherical nail The head is fitted with a spherical hole so that the rod fixing portion is rotatably disposed on the connecting screw.
  • the rod fixing portion includes a U-shaped support and a fixing cap, and the rod body is sandwiched between the U-shaped support and the fixed cap.
  • the repairing body is a hollow truss structure, and the repairing body is formed by 3D printing.
  • the second end of the first prosthesis and/or the top of the second prosthesis is provided with a porous structure.
  • the second end of the first restoration and/or the top of the second restoration are provided with needle-like projections.
  • the surface of the repairing body facing the pelvis is a smooth surface.
  • the repairing body is provided with a retaining mechanism, and the retaining mechanism is interposed between the repairing body and the connecting seat, and the retaining mechanism includes a first anti-offset antenna that cooperates with a screw housed in the first screw hole.
  • the anti-off mechanism further includes a retaining body, the anti-off body is sandwiched between the repairing body and the connecting seat, and the anti-off mechanism further includes a second anti-offset antenna, the first anti-off-angle and the second anti-offset are both The anti-off body is connected and extends outward, and the second anti-offset antenna is provided with a limiting sleeve that cooperates with the rod body.
  • the patella restoration includes a repairing body, and the repairing body includes two first prosthesis and a second prosthesis connected between the two first prostheses, and the first end of each first prosthesis The second prosthesis is connected, and the second end of each of the first prosthesis extends in a direction away from the second prosthesis and is in contact with the tibia, and the top of the second prosthesis is in contact with the lumbar vertebral body.
  • the shape of the above-mentioned repairing body forms an "eight-character" structure, has good mechanical properties, and improves the internal force distribution of the structure. Under high stress and shear forces, the stiffness of the humeral restoration can be maintained, making the bone less susceptible to damage.
  • the above structure solves the problem that the support of the nail rod system in the prior art is unreliable, easily fatigue fracture, and finally causes the bone to be easily damaged.
  • the nail bar structure comprises a connecting seat and a rod body, and the connecting seat is connected with the repairing body, and the rod body is fixed on the connecting seat.
  • the above structure strengthens the fixation between the repairing body and the lumbar vertebral body, increases the stability of the lumbar vertebral body, and avoids the sinking of the lumbar vertebrae.
  • Figure 1 shows an assembled schematic view of an embodiment of a tibial prosthesis in accordance with the present invention
  • FIG. 2 is a perspective view showing the connection structure of the connecting base of the tibial prosthesis of FIG. 1;
  • Figure 3 is a schematic longitudinal sectional view showing the connector of Figure 2;
  • Figure 4 is a perspective view showing the other structure of the connecting body of the tibial prosthesis of Figure 1;
  • Figure 5 is a schematic longitudinal sectional view showing another connecting base of Figure 4.
  • Fig. 6 is a perspective view showing the structure of the detachment prevention mechanism of the tibial prosthesis of Fig. 1.
  • the tibial prosthesis of the present embodiment includes a prosthetic body and a nail rod structure.
  • the repairing body includes two first prostheses 11 and a second prosthesis 12 connected between the two first prostheses 11.
  • the first ends of the first prostheses 11 are connected to the second prosthesis 12, two The first prosthesis 11 and the second prosthesis 12 are integrally formed.
  • the second end of each first prosthesis 11 extends away from the second prosthesis 12 and is in contact with the tibia 1 .
  • the second prosthesis 12 The top portion is in contact with the lumbar vertebral body 2;
  • the nail rod structure includes a connecting seat 22 and a rod body 23, and the connecting seat 22 is connected to the repairing body, and the rod body 23 is fixed on the connecting seat 22.
  • the humeral prosthesis includes a repairing body, and the repairing body includes two first prosthesis bodies 11 and a second prosthesis 12 connected between the two first prostheses 11 , and each of the first prosthesis bodies 11
  • the first end of the first prosthesis 11 is connected to the second prosthesis 12, and the second end of each of the first prostheses 11 extends away from the second prosthesis 12 and is in contact with the tibia 1.
  • the top of the second prosthesis 12 and the lumbar vertebrae Body 2 contact fit.
  • the above-mentioned repairing body forms an "eight-character" structure, has good mechanical properties, and improves the internal force distribution of the structure.
  • the nail bar structure includes a connecting seat 22 and a rod body 23, and the connecting seat 22 is connected to the repairing body, and the rod body 23 is fixed on the connecting seat 22.
  • the above structure strengthens the fixation between the repairing body and the lumbar vertebral body 2, increases the stability of the lumbar vertebral body 2, and avoids the sinking of the lumbar vertebrae.
  • the nail bar structure further includes a connecting seat 21, the connecting seat 21 is connected to the lumbar body, and the rod body 23 is fixed on the connecting seat 21.
  • the connecting seat 21 comprises: a connecting screw 211, a connecting screw One end of the 211 is connected to the lumbar vertebral body 2, and the other end of the connecting screw 211 has a spherical nail head 2111; a rod fixing portion 212 for fixing the rod body 23, and one end of the rod fixing portion 212 has a matching with the spherical nail head 2111. Spherical hole.
  • the above structure allows the rod fixing portion 212 to be rotated
  • the grounding is set on the connecting screw 211. In this way, the doctor can adjust the position of the rod 23 according to actual needs, thereby making the installation position more accurate and the installation process simpler.
  • the rod fixing portion 212 includes a U-shaped holder 2112 and a fixing cap 2122.
  • the rod body 23 is sandwiched between the U-shaped holder 2121 and the fixing cap 2122.
  • the U-shaped inner wall of the U-shaped holder 2121 forms an installation space, and the rod body 23 is inserted into the above-described installation space.
  • the upper portion of the U-shaped inner wall of the U-shaped holder 2121 has an internal thread
  • the fixed cap 2122 has an external thread that is adapted to the internal thread of the U-shaped holder 2121.
  • the nail bar structure further includes a connecting seat 22, and the connecting seat 22 is connected to the repairing body.
  • the connecting seat 22 includes: a connecting screw 221, and one end of the connecting screw 221 is connected with the repairing body, and the connecting screw
  • the other end of the 221 has a spherical nail head 2211; a rod fixing portion 222 for fixing the rod body 23, and one end of the rod fixing portion 222 has a spherical hole that cooperates with the spherical nail head 2211.
  • the above structure allows the rod fixing portion 222 to be rotatably provided on the connecting screw 221. In this way, the doctor can adjust the position of the rod 23 according to actual needs, thereby making the installation position more accurate and the installation process simpler.
  • the rod fixing portion 222 includes a U-shaped bracket 2221 and a fixing cap 2222.
  • the rod body 23 is sandwiched between the U-shaped bracket 2221 and the fixing cap 2222.
  • the U-shaped inner wall of the U-shaped holder 2221 forms an installation space, and the rod body 23 is inserted into the above-described installation space.
  • the upper portion of the U-shaped inner wall of the U-shaped support 2221 has an internal thread
  • the fixed cap 2222 has an external thread that is adapted to the internal thread of the U-shaped holder 2221.
  • the repairing body is a hollow truss structure.
  • the above-mentioned truss structure can greatly reduce the quality of the repairing body, improve the material utilization rate, and at the same time ensure the strength and rigidity of the repairing body.
  • the use of the above structure enables the repairing body to be closer to the adjacent bones, thereby making the effect of bone fusion better. Since anatomical reconstruction after pelvic tumor resection requires not only accurate and complex requirements, but also a one-time, tailor-made requirement. Therefore, in the present embodiment, the repairing body is formed by 3D printing. The above process itself is precise, capable of manufacturing complex parts and can be customized.
  • 3D printing rapid prototyping technology is a new manufacturing technology based on the material stacking method, which is different from the traditional material removal processing technology, also known as Additive Manufacturing (AM).
  • 3D printing technology uses 3D CAD data to stack layers of material into solids through a rapid prototyping machine.
  • Different types of rapid prototyping systems have different molding principles and system characteristics, but the basic principle is the same, that is, “layered manufacturing, layer by layer”, just like a “stereo printer”, hence the name .
  • cutting-edge technologies such as manufacturing technology, digital modeling technology, numerical control technology, information technology, materials science and chemistry, and biotechnology, and the close cooperation of multidisciplinary, the development of 3D printing technology has become the hottest new technology.
  • cutting-edge technologies such as manufacturing technology, digital modeling technology, numerical control technology, information technology, materials science and chemistry, and biotechnology
  • the first prosthesis 11 is provided with a first screw hole 111 , the first screw hole 111 is a tapered hole, and the first screw hole 111 is provided with a first nail seat, first The nail seat has a spherical inner surface.
  • the screw is first threaded into the first screw hole 111. Since the first screw hole 111 is a tapered hole, the head of the screw is a ball head, and the first nail seat has The spherical inner surface that cooperates with the ball head, so that the screw can rotate within a certain range, and the doctor can select the screwing direction of the screw according to the actual situation.
  • the above structure enables the doctor to select the screw fixing position according to the actual situation, so that the fixing effect between the repairing body and the tibia 1 is better.
  • the broken line in FIG. 1 is the direction in which the screw is inserted.
  • the second prosthesis 12 is provided with a second screw hole 121, the second screw hole 121 is a tapered hole, and the second screw hole 121 is provided with a second nail seat, and the second nail base has a spherical inner surface.
  • the above structure enables the doctor to select the screw fixing position according to the actual situation, so that the fixing effect between the repairing body and the lumbar vertebral body 2 is better.
  • the second end of the first prosthesis 11 is provided with a first porous structure (not shown).
  • the above structure can quickly promote osteoblast production and is easy to integrate with bone (tibia) to achieve a medium-and long-term fixation effect. Compared with the traditional surgical mode, it has the advantages of high strength, high stability and strong osseointegration ability.
  • the top of the second prosthesis 12 is provided with a second porous structure (not shown).
  • the above structure can rapidly promote osteogenesis and is easily integrated with bone (lumbar vertebral body) to achieve a medium-and long-term fixation effect. Compared with the traditional surgical mode, it has the advantages of high strength, high stability and strong osseointegration ability.
  • the second end of the first prosthesis 11 is provided with a first acicular projection (not shown).
  • the first acicular projection has a function of cutting anchoring to fix the tibia with the second end of the first prosthesis 11.
  • the top of the second prosthesis 12 is provided with a second acicular projection (not shown).
  • the second acicular projection has a cutting anchoring function to fix the lumbar vertebral body to the top of the second prosthesis 12.
  • the surface of the repairing body facing the pelvic cavity is a smooth surface (not shown).
  • the above structure can reduce the contusion of the tibial prosthesis to the soft tissue such as the intestinal pelvis, and further protect the soft tissue such as the intestinal pelvis in the patient.
  • the repairing body is provided with a retaining mechanism 30, and the retaining mechanism 30 is interposed between the repairing body and the connecting seat 22.
  • the retaining mechanism 30 includes and is received in the first screw hole.
  • the first anti-offset antenna 31 of the screw in the 111 is fitted.
  • the first anti-offset antenna 31 bears against the screw housed in the first screw hole 111, and the tighter the connecting screw 221 of the connecting seat 22, the first anti-offset antenna 31 bears against the screw The greater the force. Therefore, the above structure can prevent the screw from coming out of the first screw hole 111.
  • the connecting screw 221 screwed into the bone often loosens. Applying the above-described detachment prevention mechanism 30 can also provide a pre-tightening force to the connecting seat 22 to prevent the connecting seat 22 from being loosened.
  • the anti-off mechanism 30 further includes a retaining body 32.
  • the anti-off body 32 is interposed between the repairing body and the connecting seat 22.
  • the retaining mechanism 30 further includes a second anti-offset antenna. 33.
  • the first anti-offset 31 and the second anti-offset 33 are both connected to the anti-off body 32 and extend outward.
  • the second anti-offset 33 is provided with a limiting sleeve 34 that cooperates with the rod 23.
  • the first anti-detachment antenna 31 is a plurality of the first screw holes 111.
  • the retaining mechanism 30 Since the plurality of first retaining contact angles 31 extend outward into the first screw hole 111, and the retaining body 32 is interposed between the repairing body and the connecting seat 22, the retaining mechanism 30 is restrained from rotating. Moreover, since the limit sleeve 34 is disposed on the second anti-offset antenna 33, the limit sleeve 34 is matched with the rod body 23. Therefore, the rod 23 is also restricted from rotating. The above structure avoids the rotation of the rod 23, thereby increasing the stability of the system.
  • the anti-off mechanism 30 is a spring piece, the tail end of the second anti-offset contact 33 of the spring piece is upwardly lifted, and the limit sleeve 34 is disposed at the tail end of the second anti-offset contact 33.

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Abstract

一种骶骨修复体，包括：修复主体，修复主体包括两个第一修复体(11)以及连接在两个第一修复体(11)之间的第二修复体(12)，各第一修复体(11)的第一端与第二修复体(12)连接，两个第一修复体(11)和第二修复体(12)为一体成型结构，各第一修复体(11)的第二端沿远离第二修复体(12)的方向延伸并与髂骨(1)接触配合，第二修复体(12)的顶部与腰椎椎体(2)接触配合；钉棒结构，钉棒结构包括连接座(22)以及棒体(23)，连接座(22)与修复主体连接，棒体(23)固定在连接座(22)上。该技术方案能够有效地解决现有技术中的钉棒***支撑不可靠，容易疲劳断裂的问题。

Description

骶骨修复体 技术领域
本发明涉及医疗器械领域，具体而言，涉及一种骶骨修复体。
背景技术
骶骨是人体躯干与肢体连接的重要骨性结构，上方与腰椎形成腰骶关节，两侧与骨盆形成骶髂关节。由于骶骨内部不仅有重要的骶神经，而且骶髂关节也是连接中轴骨和下肢骨的唯一结构。因此，这一部位手术切除后对神经功能和结构稳定性有着较大的影响。对于患有骶骨肿瘤的患者而言，放疗、化疗与肿瘤切除相结合是多数骶骨肿瘤的首选方案。但是由于骶骨肿瘤具有早期症状少，发现时多已巨大的特点，因此对于骶骨肿瘤而言，手术时切除范围较大，对局部稳定性破坏程度严重，切除后腰骶部应力传导的恢复和稳定性的重建直接决定着患者术后功能和生活质量。恢复腰骶部最重要的三个结构：腰骶，骨盆后环，椎体前柱。特别是针对全骶骨切除的患者，全骶骨切除后的骨缺损会造成人体躯干与骨盆失去联系，患者术后有可能无法站立行走、生活无法自理等问题。如果没有对骶骨进行有效的重建，术后会出现严重的腰椎下沉和腰骶神经牵拉。上述骶骨切除术后重建是国际上骨肿瘤学界的一大难点。目前出现了多种骶骨肿瘤切除重建手术，最常用的手术方法为结构性植骨重建。结构性植骨重建主要分为两类：一类为“教堂式”重建，即通过髂骨钉及钉棒***将下位腰椎直接支撑于髂骨上；上述结构性植骨重建短期虽然能达到承重的效果，但是从长期随访观察来看，钉棒容易发生断裂或者松动，骨质受到了破坏，患者会再度陷入无法站立行走、生活无法自理的状态，必须再次实施固定手术。另一类结构性植骨重建是经髂骨棒重建，即通过植骨块或内植物将两侧髂骨连接，恢复骨盆后环，并通过钉棒***与横向的金属棒或植骨等结构进行连接，重建腰椎到髂骨的应力传导。上述结构性植骨重建早期的稳定性需要金属内植物提供，但远期的稳定性需要骨性融合，因此生物重建对于远期腰骶部稳定性至关重要。从生物力学角度来看，由于腰椎骨盆固定后力矩较长，这就造成了腰骶部会承受较高的应力和剪切力，利用上述重建方法无法实现腰椎骨盆完全融合，导致应力主要集中在金属内植物。长期如此，将会导致金属内植物疲劳断裂，进而使得金属内植物失去固定效果而被动拔出。虽然通过应用植骨、羟基磷灰石、骨水泥、长螺钉等方法能够降低金属内植物的拔出，但对于金属内植物疲劳断裂的问题并没有解决，很难实现有效的重建。
发明内容
本发明旨在提供一种骶骨修复体，以解决现有技术中的钉棒***支撑不可靠，容易疲劳断裂的问题。
为了实现上述目的，本发明提供了一种骶骨修复体，包括：修复主体，修复主体包括两个第一修复体以及连接在两个第一修复体之间的第二修复体，各第一修复体的第一端与第二 修复体连接，两个第一修复体和第二修复体为一体成型结构，各第一修复体的第二端沿远离第二修复体的方向延伸并与髂骨接触配合，第二修复体的顶部与腰椎椎体接触配合；钉棒结构，钉棒结构包连接座以及棒体，连接座与修复主体连接，棒体固定在连接座上。
进一步地，第一修复体上设置有第一螺钉孔，第一螺钉孔为锥孔，第一螺钉孔内设置有第一钉座，第一钉座具有球形内表面，和/或第二修复体上设置有第二螺钉孔，第二螺钉孔为锥孔，第二螺钉孔内设置有第二钉座，第二钉座具有球形内表面。
进一步地，连接座包括：连接螺钉，连接螺钉的一端与修复主体连接，连接螺钉的另一端具有球形钉头；棒体固定部，用以固定棒体，棒体固定部的一端具有与球形钉头相配合的球形孔，以使棒体固定部可旋转地设置在连接螺钉上。
进一步地，棒体固定部包括U形支座及固定帽，棒体夹设在U形支座与固定帽之间。
进一步地，修复主体为中空桁架结构，修复主体通过3D打印成型。
进一步地，第一修复体的第二端和/或第二修复体的顶部设置有多孔结构。
进一步地，第一修复体的第二端和/或第二修复体的顶部设置有针状凸起。
进一步地，修复主体朝向盆腔的表面为光滑表面。
进一步地，修复主体上设置有防脱机构，防脱机构夹设在修复主体与连接座之间，防脱机构包括与容纳在第一螺钉孔内的螺钉配合的第一防脱触角。
进一步地，防脱机构还包括防脱主体，防脱主体夹设在修复主体与连接座之间，防脱机构还包括第二防脱触角，第一防脱触角以及第二防脱触角均与防脱主体连接并向外延伸，第二防脱触角上设置有与棒体配合的限位套。
应用本发明的技术方案，骶骨修复体包括修复主体，修复主体包括两个第一修复体以及连接在两个第一修复体之间的第二修复体，各第一修复体的第一端与第二修复体连接，各第一修复体的第二端沿远离第二修复体的方向延伸并与髂骨接触配合，第二修复体的顶部与腰椎椎体接触配合。上述修复主体的外形轮廓形成“八字”结构，具有良好的力学性能，改善了结构的内力分布。在承受较高的应力和剪切力的情况下，能够维持骶骨修复体的刚度，使得骨质不容易受到破坏。因此上述结构解决了现有技术中的钉棒***支撑不可靠，容易疲劳断裂，最终导致骨质易受损坏的问题。此外，应用本发明的技术方案，钉棒结构包括连接座以及棒体，连接座与修复主体连接，棒体固定在连接座上。上述结构加强了修复主体与腰椎椎体之间的固定，增加了腰椎椎体的稳定性，避免了腰椎部位下沉。
附图说明
构成本申请的一部分的说明书附图用来提供对本发明的进一步理解，本发明的示意性实施例及其说明用于解释本发明，并不构成对本发明的不当限定。在附图中：
图1示出了根据本发明的骶骨修复体的实施例的装配示意图；
图2示出了图1的骶骨修复体的连接座的立体结构示意图；
图3示出了图2的连接座的纵剖结构示意图；
图4示出了图1的骶骨修复体的另一个连接座的立体结构示意图；
图5示出了图4的另一个连接座的纵剖结构示意图；以及
图6示出了图1的骶骨修复体的防脱机构的立体结构示意图。
其中，上述附图包括以下附图标记：
1、髂骨；2、腰椎椎体；11、第一修复体；111、第一螺钉孔；12、第二修复体；121、第二螺钉孔；21、连接座；211、连接螺钉；2111、球形钉头；212、棒体固定部；2121、U形支座；2122、固定帽；22、连接座；221、连接螺钉；2211、球形钉头；222、棒体固定部；2221、U形支座；2222、固定帽；23、棒体；30、防脱机构；31、第一防脱触角；32、防脱主体；33、第二防脱触角；34、限位套。
具体实施方式
需要说明的是，在不冲突的情况下，本申请中的实施例及实施例中的特征可以相互组合。下面将参考附图并结合实施例来详细说明本发明。
如图1所示，本实施例的骶骨修复体包括修复主体以及钉棒结构。其中，修复主体包括两个第一修复体11以及连接在两个第一修复体11之间的第二修复体12，各第一修复体11的第一端与第二修复体12连接，两个第一修复体11和第二修复体12为一体成型结构，各第一修复体11的第二端沿远离第二修复体12的方向延伸并与髂骨1接触配合，第二修复体12的顶部与腰椎椎体2接触配合；钉棒结构包括连接座22以及棒体23，连接座22与修复主体连接，棒体23固定在连接座22上。
应用本实施例的技术方案，骶骨修复体包括修复主体，修复主体包括两个第一修复体11以及连接在两个第一修复体11之间的第二修复体12，各第一修复体11的第一端与第二修复体12连接，各第一修复体11的第二端沿远离第二修复体12的方向延伸并与髂骨1接触配合，第二修复体12的顶部与腰椎椎体2接触配合。上述修复主体形成“八字”结构，具有良好的力学性能，改善了结构的内力分布。在承受较高的应力和剪切力的情况下，能够维持骶骨修复体的刚度，使得骨质不容易受到破坏。因此上述结构解决了现有技术中的钉棒***支撑不可靠，容易疲劳断裂，最终导致骨质易受损坏的问题。此外，应用本实施例的技术方案，钉棒结构包括连接座22以及棒体23，连接座22与修复主体连接，棒体23固定在连接座22上。上述结构加强了修复主体与腰椎椎体2之间的固定，增加了腰椎椎体2的稳定性，避免了腰椎部位下沉。
如图3所示，在本实施例中，钉棒结构还包括连接座21，连接座21与腰椎体连接，棒体23固定在连接座21上，连接座21包括：连接螺钉211，连接螺钉211的一端与腰椎椎体2连接，连接螺钉211的另一端具有球形钉头2111；棒体固定部212，用以固定棒体23，棒体固定部212的一端具有与球形钉头2111相配合的球形孔。上述结构使得棒体固定部212可旋 转地设置在连接螺钉211上。这样，使得医生可以根据实际需要调整棒体23的位置，从而使得安装位置更加准确，安装过程更加简单。
如图2所示，在本实施例中，棒体固定部212包括U形支座2121及固定帽2122，棒体23夹设在U形支座2121与固定帽2122之间。具体地，U形支座2121的U型内壁形成安装空间，棒体23***上述安装空间中。U形支座2121的U型内壁的上部具有内螺纹，固定帽2122具有与U形支座2121的内螺纹相适配的外螺纹。在安装棒体23时，需要先将棒体23从安装空间中穿出，再将固定帽2122螺接在U形支座2121上。上述结构简单、安装方便。
如图5所示，在本实施例中，钉棒结构还包括连接座22，连接座22与修复主体连接，连接座22包括：连接螺钉221，连接螺钉221的一端与修复主体连接，连接螺钉221的另一端具有球形钉头2211；棒体固定部222，用以固定棒体23，棒体固定部222的一端具有与球形钉头2211相配合的球形孔。上述结构使得棒体固定部222可旋转地设置在连接螺钉221上。这样，使得医生可以根据实际需要调整棒体23的位置，从而使得安装位置更加准确，安装过程更加简单。
如图4所示，在本实施例中，棒体固定部222包括U形支座2221及固定帽2222，棒体23夹设在U形支座2221与固定帽2222之间。具体地，U形支座2221的U型内壁形成安装空间，棒体23***上述安装空间中。U形支座2221的U型内壁的上部具有内螺纹，固定帽2222具有与U形支座2221的内螺纹相适配的外螺纹。在安装棒体23时，需要先将棒体23从安装空间中穿出，再将固定帽2222螺接在U形支座2221上。上述结构简单、安装方便。
在本实施例中，修复主体为中空桁架结构。一方面，上述桁架结构能够极大地减小修复主体的质量，提高材料利用率，同时还能够保证修复主体的强度以及刚度。另一方面，使用上述结构能够使得修复主体更加靠近相邻的骨骼，从而使得骨性融合的效果更佳。由于骨盆肿瘤切除后解剖重建不仅需要满足精准、复杂的要求，甚至于还需要一次性、量身定做的要求。因此，在本实施例中，修复主体通过3D打印成型。上述工艺本身具有精准、能够制造复杂零件且能够个性定制的特点。
需要说明的是，3D打印快速成型技术是基于材料堆积法的一种全新制造技术，区别于传统的去除材料加工技术，又称为增材制造(AM，Additive Manufacturing)。3D打印技术是利用三维CAD的数据，通过快速成型机，将一层层的材料堆积成实体。不同种类的快速成型***因所用成型材料不同，成型原理和***特点也各有差异，但是基本原理一样，那就是“分层制造，逐层叠加”，犹如一台“立体打印机”，因此得名。随着制造技术、数字建模技术、数控技术、信息技术、材料科学与化学、生物技术等前沿技术的迅猛发展以及多学科的密切合作，3D打印技术的开发已经成为当今最热门的新技术之一。3D打印未来将在骨科领域呈现广阔的应用前景，其根本原因恰在于3D打印的特点满足了骨科的特殊要求。其一、骨组织是复杂结构的典型代表，现有的仿生技术很难复制其特有的三维形态和生理功能。而3D打印正适合复杂结构的快速制造，可获得近似理想的骨修复材料；其二、由于人体存在高度的个体特异性，传统大规模、批量化生产的医疗产品无法满足个性化的需要，而以往通过模具等生产制造工艺生产出的个性化、定制产品的成本高，周期长。随着数字化影像技术在医疗领域的广泛应用，骨骼是最容易获得精确数字化影像的器官，将其与3D打印相结合，可以精确、 快速、低成本地生产个性化的医疗产品；因此，借助3D打印技术，短时间即可“铸造”出任意外形、理想的生物力学强度的内植物产品，使个体化、定制化骨植入产品的开发成为现实。
如图1所示，在本实施例中，第一修复体11上设置有第一螺钉孔111，第一螺钉孔111为锥孔，第一螺钉孔111内设置有第一钉座，第一钉座具有球形内表面。当医生需要将修复主体通过螺钉固定在髂骨1上时，首先将螺钉穿入第一螺钉孔111，由于第一螺钉孔111为锥孔，螺钉的头部为球头，第一钉座具有与球头配合的球形内表面，这样，螺钉能够在一定范围内转动，医生可以根据实际情况选择螺钉的钉入方向。上述结构使得医生能够根据实际情况选取螺钉固定位置，使得修复主体与髂骨1之间的固定效果更佳。需要说明的是，图1中的虚线为螺钉钉入的方向。同理，第二修复体12上设置有第二螺钉孔121，第二螺钉孔121为锥孔，第二螺钉孔121内设置有第二钉座，第二钉座具有球形内表面。上述结构使得医生能够根据实际情况选取螺钉固定位置，使得修复主体与腰椎椎体2之间的固定效果更佳。
在本实施例中，第一修复体11的第二端设置有第一多孔结构(图中未示出)。上述结构能够很快地促成骨细胞生成，易于与骨质(髂骨)相整合，从而达到中远期的固定效果。与传统手术模式相比，具有高强度、高稳定性、骨整合能力强的优点。
在本实施例中，第二修复体12的顶部设置有第二多孔结构(图中未示出)。上述结构能够很快地促成骨细胞生成，易于与骨质(腰椎椎体)相整合，从而达到中远期的固定效果。与传统手术模式相比，具有高强度、高稳定性、骨整合能力强的优点。
在本实施例中，第一修复体11的第二端设置有第一针状凸起(图中未示出)。上述第一针状凸起具有扦插锚定的作用，以使髂骨与第一修复体11的第二端固定在一起。
在本实施例中，第二修复体12的顶部设置有第二针状凸起(图中未示出)。上述第二针状凸起具有扦插锚定的作用，以使腰椎椎体与第二修复体12的顶部固定在一起。
在本实施例中，修复主体朝向盆腔的表面为光滑表面(图中未示出)。上述结构能够减少骶骨修复体对盆腔内肠道等软组织的挫伤，进而对患者的盆腔内肠道等软组织起到一定的保护作用。
如图6所示，在本实施例中，修复主体上设置有防脱机构30，防脱机构30夹设在修复主体与连接座22之间，防脱机构30包括与容纳在第一螺钉孔111内的螺钉配合的第一防脱触角31。使用时，当连接座22旋紧时，第一防脱触角31顶住容纳在第一螺钉孔111内的螺钉，连接座22的连接螺钉221越紧，第一防脱触角31顶住螺钉的力就越大。因此上述结构能够防止螺钉从第一螺钉孔111内脱出。此外，在现有技术中，拧入骨头的连接螺钉221经常会发生松动。应用上述防脱机构30还能够为连接座22提供预紧力以防止连接座22松动。
如图6所示，在本实施例中，防脱机构30还包括防脱主体32，防脱主体32夹设在修复主体与连接座22之间，防脱机构30还包括第二防脱触角33，第一防脱触角31以及第二防脱触角33均与防脱主体32连接并向外延伸，第二防脱触角33上设置有与棒体23配合的限位套34。优选地，第一防脱触角31为与第一螺钉孔111配合的多个。由于多个第一防脱触角31向外延伸至第一螺钉孔111内，且防脱主体32夹设在修复主体与连接座22之间，因此防脱机构30被限位无法转动。又由于第二防脱触角33上设置有限位套34，限位套34与棒体23配 合，因此棒体23也被限位无法转动。上述结构避免了棒体23的转动，从而增加了***的稳定性。
优选地，防脱机构30为弹簧片，弹簧片的第二防脱触角33的尾端向上翘起，限位套34设置在第二防脱触角33的尾端。
以上所述仅为本发明的优选实施例而已，并不用于限制本发明，对于本领域的技术人员来说，本发明可以有各种更改和变化。凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。

Claims (10)

  1. 一种骶骨修复体，其特征在于，包括：
    修复主体，所述修复主体包括两个第一修复体(11)以及连接在两个所述第一修复体(11)之间的第二修复体(12)，各所述第一修复体(11)的第一端与所述第二修复体(12)连接，两个所述第一修复体(11)和所述第二修复体(12)为一体成型结构，各所述第一修复体(11)的第二端沿远离所述第二修复体(12)的方向延伸并与髂骨(1)接触配合，所述第二修复体(12)的顶部与腰椎椎体(2)接触配合；
    钉棒结构，所述钉棒结构包连接座(22)以及棒体(23)，所述连接座(22)与所述修复主体连接，所述棒体(23)固定在所述连接座(22)上。
  2. 根据权利要求1所述的骶骨修复体，其特征在于，
    所述第一修复体(11)上设置有第一螺钉孔(111)，所述第一螺钉孔(111)为锥孔，所述第一螺钉孔(111)内设置有第一钉座，所述第一钉座具有球形内表面，和/或
    所述第二修复体(12)上设置有第二螺钉孔(121)，所述第二螺钉孔(121)为锥孔，所述第二螺钉孔(121)内设置有第二钉座，所述第二钉座具有球形内表面。
  3. 根据权利要求1所述的骶骨修复体，其特征在于，所述连接座(22)包括：
    连接螺钉(221)，所述连接螺钉(221)的一端与所述修复主体连接，所述连接螺钉(221)的另一端具有球形钉头(2211)；
    棒体固定部(222)，用以固定所述棒体(23)，所述棒体固定部(222)的一端具有与所述球形钉头(2211)相配合的球形孔，以使所述棒体固定部(222)可旋转地设置在所述连接螺钉(221)上。
  4. 根据权利要求3所述的骶骨修复体，其特征在于，所述棒体固定部(222)包括U形支座(2221)及固定帽(2222)，所述棒体(23)夹设在所述U形支座(2221)与所述固定帽(2222)之间。
  5. 根据权利要求1所述的骶骨修复体，其特征在于，所述修复主体为中空桁架结构，所述修复主体通过3D打印成型。
  6. 根据权利要求1所述的骶骨修复体，其特征在于，所述第一修复体(11)的第二端和/或所述第二修复体(12)的顶部设置有多孔结构。
  7. 根据权利要求1所述的骶骨修复体，其特征在于，所述第一修复体(11)的第二端和/或所述第二修复体(12)的顶部设置有针状凸起。
  8. 根据权利要求1所述的骶骨修复体，其特征在于，所述修复主体朝向盆腔的表面为光滑表面。
  9. 根据权利要求2的骶骨修复体，其特征在于，所述修复主体上设置有防脱机构(30)，所述 防脱机构(30)夹设在所述修复主体与所述连接座(22)之间，所述防脱机构(30)包括与容纳在所述第一螺钉孔(111)内的螺钉配合的第一防脱触角(31)。
  10. 根据权利要求9的骶骨修复体，其特征在于，所述防脱机构(30)还包括防脱主体(32)，所述防脱主体(32)夹设在所述修复主体与所述连接座(22)之间，所述防脱机构(30)还包括第二防脱触角(33)，所述第一防脱触角(31)以及所述第二防脱触角(33)均与所述防脱主体(32)连接并向外延伸，所述第二防脱触角(33)上设置有与所述棒体(23)配合的限位套(34)。
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