CN118526325A - Individualized ear-shaped surface fitting type half pelvis reconstruction prosthesis based on electric knife sacroiliac separation - Google Patents
Individualized ear-shaped surface fitting type half pelvis reconstruction prosthesis based on electric knife sacroiliac separation Download PDFInfo
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- 210000003195 fascia Anatomy 0.000 claims abstract description 4
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Classifications
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- 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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- 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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- 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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- 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
- A61F2/02—Prostheses implantable into the body
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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
- A61F2/02—Prostheses implantable into the body
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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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- 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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Abstract
本发明公开了一种基于电刀骶髂分离术的个性化耳状面贴合型半骨盆重建假体,该假体包括第一固定元件和第二固定元件;所述第一固定元件为骶髂关节面假体,与骶骨耳状面相匹配;所述第二固定元件为防脱位髋关节臼杯假体,与人工股骨头假体连接;所述骶髂关节面假体包括连接部、骶骨耳状面接触部、骶骨托和侧翼结构,且所有结构一体成型;所述连接部位于骶髂关节面假体的中下部,与防脱位髋关节臼杯假体相连接;所述骶骨耳状面接触部位于所述骶髂关节面假体上部内侧,与骶髂骨离断面配合;所述骶骨托设于骶骨耳状面接触部下部;所述侧翼结构位于骶髂关节面假体上部外侧,用于固定臀大肌及其筋膜。本发明的假体有利于降低术后并发症,并能够提高患肢功能。
The invention discloses a personalized ear-shaped surface fitting hemipelvic reconstruction prosthesis based on electrosurgical sacroiliac separation, the prosthesis comprising a first fixing element and a second fixing element; the first fixing element is a sacroiliac joint surface prosthesis, which matches the sacral ear-shaped surface; the second fixing element is an anti-dislocation hip joint acetabulum prosthesis, which is connected to an artificial femoral head prosthesis; the sacroiliac joint surface prosthesis comprises a connecting portion, a sacral ear-shaped surface contact portion, a sacral support and a flank structure, and all structures are integrally formed; the connecting portion is located at the middle and lower part of the sacroiliac joint surface prosthesis, and is connected to the anti-dislocation hip joint acetabulum prosthesis; the sacral ear-shaped surface contact portion is located at the inner side of the upper part of the sacroiliac joint surface prosthesis, and cooperates with the sacroiliac fracture surface; the sacral support is arranged at the lower part of the sacral ear-shaped surface contact portion; the flank structure is located at the outer side of the upper part of the sacroiliac joint surface prosthesis, and is used to fix the gluteus maximus and its fascia. The prosthesis of the invention is conducive to reducing postoperative complications and can improve the function of the affected limb.
Description
技术领域Technical Field
本发明涉及医用假体领域,更具体的说是涉及一种基于电刀骶髂分离术的个性化耳状面贴合型半骨盆重建假体The present invention relates to the field of medical prosthesis, and more specifically to a personalized ear-shaped surface fitting hemipelvic reconstruction prosthesis based on electrosurgery sacroiliac separation
背景技术Background Art
骨盆肿瘤是发生于骨盆的骨肿瘤,包括:骨肉瘤、软骨肉瘤、尤文氏肉瘤、淋巴瘤、骨髓瘤、转移癌等。按照Enneking分型,骨盆肿瘤的切除与功能重建可分为:Ⅰ型:髂骨切除;Ⅱ型:髋臼周围切除;Ⅲ型:坐骨、耻骨切除;Ⅳ型:切除范围涉及骶骨。对于累及Enneking I+II+(III)区的骨盆肿瘤,因髂骨和髋臼被肿瘤广泛侵犯,需大范围切除骨质,造成周围骨质大范围缺失,用于重建骨盆环结构的半骨盆假体固定困难。因此,如何在骨盆肿瘤切除术后重建稳定的内半骨盆结构是骨科医生面临的重大挑战。Pelvic tumors are bone tumors that occur in the pelvis, including osteosarcoma, chondrosarcoma, Ewing's sarcoma, lymphoma, myeloma, metastatic cancer, etc. According to the Enneking classification, the resection and functional reconstruction of pelvic tumors can be divided into: Type I: iliac resection; Type II: acetabular peri-resection; Type III: ischium and pubic resection; Type IV: resection involves the sacrum. For pelvic tumors involving the Enneking I+II+(III) zone, because the ilium and acetabulum are widely invaded by the tumor, large-scale bone resection is required, resulting in large-scale loss of surrounding bone, and it is difficult to fix the hemipelvic prosthesis used to reconstruct the pelvic ring structure. Therefore, how to reconstruct a stable internal hemipelvic structure after pelvic tumor resection is a major challenge facing orthopedic surgeons.
目前,骨盆重建方法主要有半骨盆假体、异体半骨盆、自体瘤骨灭活再植、股骨头上移等,其中人工半骨盆假体重建因其初始稳定性较好,外形易被接受以及功能恢复相对较快等特点,在肿瘤切除术后骨盆重建中占据主导地位。对于骨盆I+II+(III)切除的患者,目前临床上常用的人工半骨盆假体主要包括:组配式假体、3D打印假体、臼杯联合钉棒固定等。在肿瘤切除时,常采用超声骨刀或线锯垂直截骨,随后利用螺钉将上述假体固定在骶骨上,实现内半骨盆重建。然而,上述重建手段,存在如下三个问题:(1)经垂直截骨后进行假体安装,假体与骶骨的接触界面几乎垂直,导致螺钉剪切应力过大,术后假体松动率、断端率较高。(2)I+II+(III)区肿瘤切除后骨性标志物丢失,导致假体的安装位置很难判断,术中难以实现髋臼旋转中心的原位重建。当前,已有文献证实,髋臼旋转中心的原位重建,有利于降低术后假体脱位的风险。(3)当前假体需依赖螺钉固定在骶骨上,螺钉的长度和植入方向仅依靠手术医生个人习惯、操作经验,常导致骶骨螺钉植入位置不准确,需反复透视调整,甚至可能突破入骶管或骶骨前/后方皮质,存在潜在的损伤血管神经风险。At present, the main methods of pelvic reconstruction include hemipelvic prosthesis, allogeneic hemipelvic bone, autologous tumor bone inactivation and replantation, and femoral head upward movement. Among them, artificial hemipelvic prosthesis reconstruction occupies a dominant position in pelvic reconstruction after tumor resection due to its good initial stability, easy-to-accept appearance, and relatively fast functional recovery. For patients with pelvic I+II+(III) resection, the artificial hemipelvic prosthesis commonly used in clinical practice mainly includes: modular prosthesis, 3D printed prosthesis, acetabular cup combined with screw rod fixation, etc. During tumor resection, ultrasonic bone knife or wire saw is often used for vertical osteotomy, and then the above prosthesis is fixed to the sacrum with screws to achieve internal hemipelvic reconstruction. However, the above reconstruction methods have the following three problems: (1) After vertical osteotomy, the prosthesis is installed, and the contact interface between the prosthesis and the sacrum is almost vertical, resulting in excessive screw shear stress, and a high rate of prosthesis loosening and end fracture after surgery. (2) After tumor resection in zone I+II+(III), bone markers are lost, making it difficult to determine the installation position of the prosthesis and to achieve in situ reconstruction of the acetabular rotation center during surgery. Currently, existing literature has confirmed that in situ reconstruction of the acetabular rotation center is beneficial to reducing the risk of postoperative prosthesis dislocation. (3) Currently, the prosthesis needs to be fixed to the sacrum with screws. The length and implantation direction of the screws depend only on the surgeon's personal habits and operating experience, which often leads to inaccurate implantation of the sacral screws, requiring repeated fluoroscopic adjustments, and may even break through the sacral canal or the anterior/posterior cortex of the sacrum, posing a potential risk of damaging blood vessels and nerves.
因此,设计一种新型个性化定制的半骨盆假体用于骨盆I+II+(III)区肿瘤切除术后重建,具有重要的意义,Therefore, it is of great significance to design a new type of personalized hemipelvic prosthesis for reconstruction after pelvic I+II+(III) zone tumor resection.
发明内容Summary of the invention
本发明的目的是针对现有假体技术难以实现髋臼旋转中心原位重建、术中骶骨螺钉植入风险大、术后假体易断钉松动等不足之处,提供一种基于电刀骶髂分离术的个性化耳状面贴合型半骨盆重建假体,该假体有利于降低术后并发症,并能够提高患肢功能。该假体在制备过程中,利用3D打印技术,构建可与骶骨耳状面精确匹配的假体耳状面,并在此基础上,将假体臼杯设计在髋臼生理部位,将假体侧面的螺钉孔角度朝向骶骨椎体。The purpose of the present invention is to provide a personalized ear-shaped surface fitting hemipelvic reconstruction prosthesis based on electrosurgical sacroiliac separation surgery, which is beneficial to reduce postoperative complications and improve the function of the affected limb. In the preparation process of the prosthesis, 3D printing technology is used to construct a prosthetic ear-shaped surface that can accurately match the sacral ear-shaped surface, and on this basis, the prosthetic acetabular cup is designed in the physiological position of the acetabulum, and the screw hole angle on the side of the prosthesis is directed toward the sacral vertebral body.
本发明解决其技术问题所采用的技术方案是:The technical solution adopted by the present invention to solve the technical problem is:
一种基于电刀骶髂分离术的个性化耳状面贴合型半骨盆重建假体,主要包括第一固定元件和第二固定元件两部分;第一固定元件为骶髂关节面假体,与骶骨相连接,第二固定元件为防脱位髋关节臼杯假体,与人工股骨头相连接。A personalized ear-shaped surface-fitting hemi-pelvic reconstruction prosthesis based on electrosurgical sacroiliac separation mainly includes a first fixing element and a second fixing element; the first fixing element is a sacroiliac joint surface prosthesis connected to the sacrum, and the second fixing element is an anti-dislocation hip joint acetabulum prosthesis connected to an artificial femoral head.
上述技术方案中,进一步地,所述第一固定元件为一与骶骨耳状面相匹配的结构,骶髂关节面假体包括与防脱位髋关节臼杯假体相连接的连接部、骶骨耳状面接触部、骶骨托和侧翼结构;且所述连接部、骶骨耳状面接触部、骶骨托和侧翼结构一体成型。In the above technical solution, further, the first fixing element is a structure that matches the sacral ear surface, and the sacroiliac joint surface prosthesis includes a connecting portion connected to the anti-dislocation hip acetabulum prosthesis, a sacral ear surface contact portion, a sacral support and a side wing structure; and the connecting portion, the sacral ear surface contact portion, the sacral support and the side wing structure are integrally formed.
进一步地,所述第一固定元件中,连接部位于整体结构中下部,为一圆柱体结构,所述圆柱体结构底部设有卡槽孔;所述防脱位髋关节臼杯假体上部设有圆柱形卡块,所述圆柱形卡块与卡槽孔相匹配,二者配合用于实现骶髂关节面假体与防脱位髋关节臼杯假体(第二固定元件)连接;Further, in the first fixing element, the connecting portion is located in the lower middle part of the overall structure and is a cylindrical structure, and a slot hole is provided at the bottom of the cylindrical structure; a cylindrical clamping block is provided at the upper part of the anti-dislocation hip acetabulum prosthesis, and the cylindrical clamping block matches the slot hole, and the two cooperate to realize the connection between the sacroiliac joint surface prosthesis and the anti-dislocation hip acetabulum prosthesis (second fixing element);
进一步地,所述第一固定元件中,所述骶骨耳状面接触部位于骶髂关节面假体内侧,其上设有若干能够顺应人体正常骨组织生物力学性能的螺纹孔,所述螺纹孔的通孔直径范围为4mm-8mm,沉头孔径为6mm-10mm;所述螺纹孔用于穿过骶骨螺钉,从而使假体与骶骨连接固定,且术前设计螺纹孔的角度以及骶骨螺钉的长度可避免术中螺钉置入骶管或损伤临近血管;进一步地,所述骶骨耳状面接触部为一仿生骨小梁结构,接触部为漏斗形,其与骶髂骨离断面高度配合,可以有效降低术后垂直剪切力,以提高假体早期安装稳定性;作为优选地,所述骶骨耳状面接触部是采用Ti-6AI-4V合金粉末进行3D打印构建的多孔隙仿生结构,可提供足够的摩擦力并有利于骨长入,促进骨整合,增加假体后期稳定性;所述骶骨耳状面接触部的厚度为50mm-200mm,孔隙的孔径为200μm-800μm,丝径为500-600μm,孔隙率为50%-80%。Furthermore, in the first fixing element, the sacral ear-shaped surface contact portion is located inside the sacroiliac joint surface prosthesis, and is provided with a plurality of threaded holes that can conform to the biomechanical properties of normal human bone tissue, the through hole diameter range of the threaded hole is 4mm-8mm, and the countersunk hole diameter is 6mm-10mm; the threaded hole is used to pass the sacral screw, so that the prosthesis is connected and fixed to the sacrum, and the angle of the threaded hole and the length of the sacral screw designed before the operation can avoid the screw from being inserted into the sacral canal or damaging the adjacent blood vessels during the operation; further, the sacral ear-shaped surface contact portion is a bionic trabecular bone structure, and the contact portion It is funnel-shaped, which is highly matched with the sacroiliac fracture surface, and can effectively reduce the vertical shear force after surgery to improve the early installation stability of the prosthesis; preferably, the sacral ear-shaped surface contact part is a porous bionic structure constructed by 3D printing using Ti-6AI-4V alloy powder, which can provide sufficient friction and is conducive to bone ingrowth, promote bone integration, and increase the later stability of the prosthesis; the thickness of the sacral ear-shaped surface contact part is 50mm-200mm, the pore diameter is 200μm-800μm, the wire diameter is 500-600μm, and the porosity is 50%-80%.
进一步地,所述第一固定元件中,骶骨托设于骶骨耳状面接触部下部,可减少与“假体-骶骨”接触界面的剪切应力,为术后初始稳定和早期假体负重提供有力支撑。Furthermore, in the first fixing element, the sacrum support is arranged at the lower part of the contact part of the sacrum ear surface, which can reduce the shear stress at the "prosthesis-sacrum" contact interface and provide strong support for the initial postoperative stability and early prosthesis load-bearing.
进一步地,所述骶骨耳状面接触部和骶骨托结构的联合可以实现更好的早期假体稳定性,减少早期剪切力。Furthermore, the combination of the sacral ear-shaped surface contact portion and the sacral support structure can achieve better early prosthesis stability and reduce early shear force.
进一步地,所述第一固定元件中,侧翼结构为假体外侧上部向外延伸一体成型的一近半圆形结构,其上均匀设有孔洞结构,所述孔洞的孔径范围为8mm-12mm,可按需固定臀大肌及其筋膜,用于臀大肌等软组织重建。Furthermore, in the first fixing element, the wing structure is a nearly semicircular structure integrally formed by extending outward from the upper outer part of the prosthesis, and is evenly provided with hole structures. The hole diameter ranges from 8mm to 12mm, which can fix the gluteus maximus and its fascia as needed, and is used for reconstruction of soft tissues such as the gluteus maximus.
进一步地,所述骶髂关节面假体上还设有螺纹孔,所述螺纹孔的孔径范围为4mm-8mm,所述螺纹孔用于穿过万向钉,以尾帽固定腰骶连接杆的一端,所述腰骶连接杆的另一端通过腰椎钉与腰椎连接,实现腰骶固定;作为优选地,所述螺纹孔方向与正常骨生物力学传导方向一致,使术中、术后螺钉剪切受力减少。Furthermore, a threaded hole is provided on the sacroiliac joint surface prosthesis, and the aperture range of the threaded hole is 4mm-8mm. The threaded hole is used to pass the universal nail, and one end of the lumbar-sacral connecting rod is fixed with the tail cap, and the other end of the lumbar-sacral connecting rod is connected to the lumbar vertebra through a lumbar screw to achieve lumbar fixation; preferably, the direction of the threaded hole is consistent with the normal bone biomechanical conduction direction, so as to reduce the shear force of the screw during and after the operation.
更进一步地,所述第一固定元件中,骶骨耳状面接触部和第一固定元件上的螺纹孔分别用于实现“假体-骶骨”固定以及腰骶固定,二者联合固定会实现更好的即刻稳定性,降低垂直剪切应力,利于患者早期部分负重行走,改善预后。Furthermore, in the first fixation element, the sacral ear surface contact portion and the threaded hole on the first fixation element are respectively used to achieve "prosthesis-sacrum" fixation and lumbar-sacral fixation. The combined fixation of the two will achieve better immediate stability, reduce vertical shear stress, facilitate early partial weight-bearing walking for patients, and improve prognosis.
进一步地,所述第二固定元件为一半球形髋臼窝结构。Furthermore, the second fixing element is a hemispherical acetabular structure.
进一步地,所述第二固定元件臼杯假体位于整体结构下端,与人工股骨头假体连接;采用超半径双动结构,以有效避免内衬脱位;同时采用自锁设计聚乙烯卡扣预防假体球头脱位。Furthermore, the second fixing element, the acetabular cup prosthesis, is located at the lower end of the overall structure and connected to the artificial femoral head prosthesis; an ultra-radius double-action structure is adopted to effectively avoid dislocation of the liner; and a self-locking polyethylene buckle is used to prevent dislocation of the prosthetic ball head.
进一步地,所述第一固定元件中假体连接部与第二固定元件半球形臼杯假体上各设有一组黑色短线(作为标记,也可采用其他形式),对齐后可预设防脱位髋关节臼杯假体前倾角为15°,外展角为40°,顺应人体生物力学功能;作为优选,所述防脱位髋关节假体为可旋转设计,能按需调整前倾角,增加手术容错率。Furthermore, a group of short black lines (as marks, other forms may also be used) are respectively provided on the prosthesis connecting portion in the first fixing element and the hemispherical acetabulum prosthesis of the second fixing element. After alignment, the anti-dislocation hip acetabulum prosthesis can be preset with an anteversion angle of 15° and an abduction angle of 40°, which conform to the biomechanical functions of the human body; preferably, the anti-dislocation hip prosthesis is rotatable in design, and the anteversion angle can be adjusted as needed to increase the surgical tolerance.
通过采用上述技术方案,本发明可以实现骶骨-髂骨-髋关节的稳定精确重建,恢复骨盆肿瘤切除后患者的行走功能;在肿瘤切除阶段,不同于传统临床上采用的利用线锯或超声骨刀垂直截骨方式,改为经电刀沿骶骨耳状面截骨,不仅保留了软骨下骨,且经关节面离断能更好的确保肿瘤切缘阴性,并根据骶髂关节接触面个性化设计并经3D打印得到耳状面,使假体的漏斗形与骶骨耳状面紧密贴合,降低了垂直剪切力,并实现髋臼旋转中心原位重建;其上仿生骨小梁结构可以实现假体与骶髂关节的生物连接,促进新生骨长入,有利于骨整合,提高后期假体固定的稳定性;骶骨耳状面接触部的骶骨托结构在骶骨的纵向水平形成支撑,可进一步降低垂直剪切力,为初始稳定和早期假体负重提供有力的保证;考虑到患者个体的异质性,本发明可以根据患者实际需要设计骶骨螺钉方向和长度,使其与患者骶骨生理结构相匹配,减少术中损伤血管神经的风险。并按需使用万向钉固定腰骶连接杆,通过腰5椎弓根钉进行腰骶固定,进一步降低剪切应力,减少术后断钉及假体松动的发生率。同时配备可旋转臼杯假体设计,对齐固定件连接部和半球形髋关节假体黑色标注短线后,使臼杯假体符合人体正常生物力学功能的前倾和外展角度,并能按需调节前倾角,实现个性化定制方案;连接部通过嵌入式连接设计,防脱位髋关节臼杯假体超半径双动结构及自锁设计聚乙烯卡扣设计,进一步加强假体连接,提高稳定性,减少术后假体松动发生。By adopting the above technical scheme, the present invention can realize stable and accurate reconstruction of the sacrum-ilium-hip joint and restore the walking function of patients after pelvic tumor resection; in the tumor resection stage, different from the traditional clinical vertical osteotomy method using wire saw or ultrasonic bone knife, it is changed to osteotomy along the auricular surface of the sacrum through electric knife, which not only retains the subchondral bone, but also can better ensure the negative tumor resection margin through articular surface separation, and according to the personalized design of the sacroiliac joint contact surface and the auricular surface obtained by 3D printing, the funnel shape of the prosthesis is closely fitted with the auricular surface of the sacrum, which reduces the vertical shear force and realizes hip The mortar rotation center is reconstructed in situ; the bionic trabecular structure on it can realize the biological connection between the prosthesis and the sacroiliac joint, promote the growth of new bone, facilitate bone integration, and improve the stability of the prosthesis fixation in the later stage; the sacral support structure of the sacral ear surface contact part forms a support in the longitudinal level of the sacrum, which can further reduce the vertical shear force and provide a strong guarantee for the initial stability and early prosthesis load; considering the heterogeneity of individual patients, the present invention can design the direction and length of the sacral screw according to the actual needs of the patient, so that it matches the physiological structure of the patient's sacrum, reducing the risk of intraoperative damage to blood vessels and nerves. And use a universal screw to fix the lumbar sacral connecting rod as needed, and use the lumbar 5 pedicle screw for lumbar fixation, further reducing the shear stress, and reducing the incidence of postoperative broken screws and prosthesis loosening. It is also equipped with a rotatable acetabular prosthesis design. After aligning the black marked short line of the fixing connection and the hemispherical hip prosthesis, the acetabular prosthesis conforms to the anteversion and abduction angles of the normal biomechanical function of the human body, and the anteversion angle can be adjusted as needed to achieve a personalized customization plan; the connection part uses an embedded connection design, an anti-dislocation hip acetabular prosthesis super-radius double-action structure and a self-locking polyethylene buckle design to further strengthen the prosthesis connection, improve stability, and reduce the occurrence of postoperative prosthesis loosening.
本发明的有益效果在于:The beneficial effects of the present invention are:
传统方法利用超声骨刀或线锯在骶骨上进行垂直方向截骨,随后安装假体,造成假体与骶骨连接部位近乎垂直的界面上所受剪切力过大,假体术后易松动和断端,且术中假体安装位置、骶骨螺钉植入方向不确切等问题,本发明的个性化3D打印半骨盆耳状面假体具备以下有益效果:The traditional method uses an ultrasonic bone knife or a wire saw to perform vertical osteotomy on the sacrum, and then installs the prosthesis, which causes excessive shear force on the nearly vertical interface between the prosthesis and the sacrum, and the prosthesis is easy to loosen and break after surgery. In addition, the prosthesis installation position and sacral screw implantation direction are not accurate during the operation. The personalized 3D printed hemipelvic auricular surface prosthesis of the present invention has the following beneficial effects:
1.在骨盆肿瘤切除阶段,部分患者肿瘤未累及臀大肌及其周围软组织,在肿瘤完整切除后,上述组织被部分或完整的保留下来。本发明耳状面贴合型半骨盆假体第一固定元件中侧翼结构预留的多孔洞结构,可按需固定臀大肌及其筋膜等,进行软组织重建,改善患肢肌力;1. During the pelvic tumor resection stage, some patients' tumors do not involve the gluteus maximus and its surrounding soft tissues. After the tumor is completely removed, the above tissues are partially or completely preserved. The multi-hole structure reserved in the flank structure of the first fixing element of the ear-shaped surface fitting hemi-pelvic prosthesis of the present invention can fix the gluteus maximus and its fascia as needed, perform soft tissue reconstruction, and improve the muscle strength of the affected limb;
2.在骨盆肿瘤切除阶段,根据不同患者肿瘤累及的范围不同,在Ⅱ区或Ⅲ区截骨后,其次处理骨盆Ⅰ区骶髂关节处,利用电刀逐步切除连接骶髂关节的韧带,实现关节脱位。考虑到肿瘤在发生发展过程中不易突破关节面,使用此法摘除肿瘤,可更好的保证肿瘤切缘阴性,有利于降低术后肿瘤局部复发率,改善肿瘤学预后。同时,保留软骨下骨,对于假体第一固定元件中仿生骨小梁结构的骨长入有重要作用,增加骨整合,提高假体晚期固定的稳定性;而传统手术因为是利用线锯或超声骨刀垂直截骨,破坏了骶髂关节面,软骨下骨丢失,无法实现上述效应。2. During the pelvic tumor resection stage, according to the different extent of tumor involvement in different patients, after osteotomy in zone II or zone III, the sacroiliac joint in zone I of the pelvis is then treated, and the ligaments connecting the sacroiliac joint are gradually removed using an electric knife to achieve joint dislocation. Considering that it is not easy for tumors to break through the joint surface during their occurrence and development, using this method to remove the tumor can better ensure that the tumor margin is negative, which is beneficial to reducing the local recurrence rate of postoperative tumors and improving oncological prognosis. At the same time, retaining subchondral bone plays an important role in the bone ingrowth of the bionic trabecular structure in the first fixation element of the prosthesis, increasing bone integration, and improving the stability of the late fixation of the prosthesis; traditional surgery uses a wire saw or ultrasonic bone knife to vertically cut the sacroiliac joint surface, causing subchondral bone loss, and cannot achieve the above effects.
3.同时,经电刀分离骶髂关节,可保留骶骨耳状面凹凸不平的结构,使假体第一固定元件中耳状面接触部与骶骨耳状面完整贴合匹配,便于假体精准安放,该结合面为凹凸不平的漏斗状结构,极大地减小了接触界面假体所受的垂直剪切应力,提高假体早期固定的稳定性;此外,其第一固定元件中骶骨托结构和腰骶连接杆能进一步降低剪切力,减少术后假体断钉及松动的发生,并依赖于上述精确匹配,可实现髋臼旋转中心的精准原位重建,有效降低髋臼术后脱位率的发生,改善患者预后;而传统手术利用线锯或超声骨刀进行垂直截骨,导致截骨界面近乎垂直,剪切力大,此外,截骨的界面不可控,假体无法精准安放,难以实现旋转中心的原位重建。3. At the same time, the sacroiliac joint is separated by electrosurgery, and the uneven structure of the sacral ear-shaped surface can be retained, so that the contact part of the ear-shaped surface of the first fixing element of the prosthesis can be completely fitted with the sacral ear-shaped surface, which is convenient for the precise placement of the prosthesis. The joint surface is an uneven funnel-shaped structure, which greatly reduces the vertical shear stress on the contact interface prosthesis and improves the stability of the early fixation of the prosthesis. In addition, the sacral support structure and the lumbar sacral connecting rod in the first fixing element can further reduce the shear force and reduce the occurrence of postoperative prosthesis breakage and loosening. Relying on the above-mentioned precise matching, the precise in situ reconstruction of the acetabulum rotation center can be achieved, effectively reducing the occurrence of postoperative acetabulum dislocation rate and improving patient prognosis. Traditional surgery uses a wire saw or an ultrasonic bone knife for vertical osteotomy, resulting in a nearly vertical osteotomy interface and a large shear force. In addition, the osteotomy interface is uncontrollable, the prosthesis cannot be accurately placed, and it is difficult to achieve in situ reconstruction of the rotation center.
4.在将假体与骶骨固定时,骶骨耳状面接触部的孔洞结构在术前3D打印设计假体时已根据患者个体情况预留合适的方向,不仅顺应人体正常生物力学功能,且术中沿孔洞结构植入骶骨螺钉可很大程度避免螺钉穿破骶孔或骶骨前/后方骨皮质,有效降低螺钉损伤血管神经的风险。此外,其余两组孔洞结构皆顺应人体生物力学功能。4. When fixing the prosthesis to the sacrum, the hole structure of the contact part of the auricular surface of the sacrum has reserved a suitable direction according to the individual patient's situation when designing the prosthesis by 3D printing before surgery. It not only conforms to the normal biomechanical function of the human body, but also implants the sacral screws along the hole structure during surgery to a large extent to avoid the screws from penetrating the sacral foramen or the anterior/posterior cortical bone of the sacrum, effectively reducing the risk of screws damaging blood vessels and nerves. In addition, the hole structures of the other two groups conform to the biomechanical function of the human body.
5.假体的多重固定结构增加假体稳定性:骶骨耳状面接触部的漏斗形结构和骶骨托结构的一重锁定结构可以更好的降低早期剪切力。此外,联合骶骨耳状面接触部和第一固定元件的孔洞结构,可实现“假体与骶骨”固定和腰骶固定,构成假体的二重锁定结构,而且会实现更好的早期即刻稳定性,利于患者早期部分负重行走,改善预后。骶骨耳状面接触部采用仿生骨小梁结构可增加接触界面的摩擦力,并促进新生骨长入骨小梁孔隙中,促进骨整合,增加假体后期稳定性。5. The multiple fixation structures of the prosthesis increase the stability of the prosthesis: the funnel-shaped structure of the sacral auricular surface contact part and the single locking structure of the sacral support structure can better reduce the early shear force. In addition, the hole structure of the sacral auricular surface contact part and the first fixation element can realize the "prosthesis and sacrum" fixation and lumbar sacral fixation, forming a double locking structure of the prosthesis, and will achieve better early immediate stability, which is beneficial for the patient to walk with partial weight bearing in the early stage and improve the prognosis. The bionic trabecular structure of the sacral auricular surface contact part can increase the friction of the contact interface, promote the growth of new bone into the trabecular pores, promote bone integration, and increase the late stability of the prosthesis.
6.在将假体与股骨固定时,对齐第一固定元件中连接部与第二固定元件半球形臼杯假体上的两组黑色短线,可预设防脱位髋关节臼杯假体的前倾角为15°,外展角为40°,并可能按需调整前倾角,顺应人体生物力学功能并增加手术容错率。6. When fixing the prosthesis to the femur, align the two sets of black short lines on the connecting part of the first fixing element and the hemispherical acetabular cup prosthesis of the second fixing element. The anteversion angle of the anti-dislocation hip acetabular cup prosthesis can be preset to 15° and the abduction angle to 40°, and the anteversion angle may be adjusted as needed to conform to the biomechanical function of the human body and increase the surgical tolerance rate.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
下面结合附图对本发明型做进一步的说明:The present invention will be further described below in conjunction with the accompanying drawings:
图1为本发明的分解结构示意图之一。FIG. 1 is a schematic diagram of a decomposed structure of the present invention.
图2为本发明的分解结构示意图之二。FIG. 2 is a second schematic diagram of the decomposed structure of the present invention.
图3为本发明的结构示意图之一。FIG. 3 is a schematic diagram of the structure of the present invention.
图4为本发明的结构示意图之二。FIG. 4 is a second schematic diagram of the structure of the present invention.
图5为本发明的假体安装后的正面结构示意图。FIG. 5 is a schematic diagram of the front structure of the prosthesis of the present invention after installation.
图6为本发明的假体安装后的背面结构示意图。FIG. 6 is a schematic diagram of the back structure of the prosthesis of the present invention after installation.
图7为本发明的假体骶骨螺钉固定后的正面结构示意图。FIG. 7 is a schematic diagram of the front structure of the prosthesis sacrum after being fixed with screws of the present invention.
图8为本发明的假体腰椎钉固定后的背面结构示意图。FIG. 8 is a schematic diagram of the back structure of the prosthetic lumbar vertebra after fixation with screws of the present invention.
图9为本发明的假体腰椎钉固定后的正面结构示意图。FIG. 9 is a schematic diagram of the front structure of the prosthetic lumbar vertebra after fixation with screws of the present invention.
其中,骶髂关节面假体1,骶骨托101,骶骨耳状面接触部102,侧翼结构103,防脱位髋关节臼杯假体连接部104,螺纹孔a 105,螺纹孔b 106,螺纹孔c107,黑色短线108,防脱位髋关节臼杯假体2,骶骨3,髂骨4,骶骨螺钉5,万向钉6,腰骶连接杆7,腰椎钉8。Among them, sacroiliac joint surface prosthesis 1, sacral support 101, sacral ear surface contact part 102, flank structure 103, anti-dislocation hip acetabulum prosthesis connection part 104, threaded hole a 105, threaded hole b 106, threaded hole c 107, black short line 108, anti-dislocation hip acetabulum prosthesis 2, sacrum 3, ilium 4, sacral screw 5, universal nail 6, lumbar sacral connecting rod 7, lumbar nail 8.
具体实施方式DETAILED DESCRIPTION
下面结合附图对本发明做进一步地说明。The present invention will be further described below in conjunction with the accompanying drawings.
一种基于电刀骶髂分离术的个性化耳状面贴合型半骨盆重建假体,见附图1~9,包括与患者的骶髂关节相匹配的骶髂关节面假体1和防脱位髋关节臼杯假体2,所述骶髂关节面假体1包括骶髂关节骶骨托101、骶骨耳状面接触部102、侧翼结构103以及连接部104,所述骶髂关节面假体1中的所有结构一体成型,能够实现假体的早期稳定性,增加骨整合几率。骶骨耳状面接触部102通过周围包边结构与骨性结构准确、牢固结合在一起,并借助螺钉加强固定,完成假体接触面与骨质表面的精确结合,同时可以实现骨盆旋转中心原位重建,增强假体的稳定性。A personalized ear-shaped surface fitting hemipelvic reconstruction prosthesis based on electrosurgical sacroiliac separation, as shown in Figures 1 to 9, includes a sacroiliac joint surface prosthesis 1 that matches the patient's sacroiliac joint and an anti-dislocation hip joint acetabulum prosthesis 2. The sacroiliac joint surface prosthesis 1 includes a sacroiliac joint sacral support 101, a sacral ear-shaped surface contact portion 102, a wing structure 103, and a connecting portion 104. All structures in the sacroiliac joint surface prosthesis 1 are integrally formed, which can achieve early stability of the prosthesis and increase the probability of bone integration. The sacral ear-shaped surface contact portion 102 is accurately and firmly combined with the bone structure through the surrounding edging structure, and is fixed with screws to complete the precise combination of the prosthesis contact surface and the bone surface. At the same time, the in-situ reconstruction of the pelvic rotation center can be achieved to enhance the stability of the prosthesis.
本发明的半骨盆假体是术前根据患者骨盆薄层CT扫描数据,重建骨盆的三维数据模型。在计算机上设计半骨盆假体,该假体关节面与骨盆肿瘤侧骶骨耳状面解剖基本贴合。在假体上设计植入骶骨内的螺钉通道,可避免术中螺钉植入骶管损伤神经或植入骶骨前方损伤血管。The hemipelvic prosthesis of the present invention is a three-dimensional data model of the pelvis reconstructed based on the thin-layer CT scan data of the patient's pelvis before surgery. The hemipelvic prosthesis is designed on a computer, and the articular surface of the prosthesis is basically in line with the anatomical auricular surface of the sacrum on the side of the pelvic tumor. The screw channel designed on the prosthesis for implantation into the sacrum can avoid damage to the nerves when the screw is implanted into the sacral canal or damage to the blood vessels when the screw is implanted in the front of the sacrum during surgery.
本发明申请的骶髂关节面假体1的支撑部采用骶骨托101,骶髂关节是一个纵向平面,而骶骨托101设于在骶骨耳状面接触部102下部,在使用顺应人体正常骨组织生物力学性能的骶骨螺钉固定后,与骶骨耳状面接触部102联合为初始稳定和早期假体负重提供有力的支撑,重建了下肢力线的传导,从而实现早期恢复患者骨盆肿瘤切除术后的行走功能。利用电刀切断韧带,行骶髂关节脱位分离髂骨,可保留软骨下骨,这对维持假体固定稳定性有重要的作用,可保证假体不易下沉,进一步提高假体的稳定性。The support part of the sacroiliac joint surface prosthesis 1 of the present invention adopts a sacral support 101. The sacroiliac joint is a longitudinal plane, and the sacral support 101 is arranged at the lower part of the sacral ear-shaped surface contact part 102. After being fixed with a sacral screw that conforms to the biomechanical properties of normal human bone tissue, it is combined with the sacral ear-shaped surface contact part 102 to provide strong support for initial stability and early prosthesis load-bearing, and reconstruct the conduction of the lower limb force line, thereby achieving early recovery of the patient's walking function after pelvic tumor resection. Using an electric knife to cut the ligament and perform sacroiliac joint dislocation to separate the ilium can retain the subchondral bone, which plays an important role in maintaining the stability of the prosthesis fixation, and can ensure that the prosthesis is not easy to sink, further improving the stability of the prosthesis.
所述骶骨耳状面接触部102的形状为漏斗形,其与人体骶髂关节离断面相吻合;所述连接部104的下部为圆柱体结构,用于与所述防脱位髋关节臼杯假体2连接;所述防脱位髋关节臼杯假体2为半球形髋臼窝结构。The shape of the sacral ear-shaped contact portion 102 is funnel-shaped, which is consistent with the cross-sectional surface of the human sacroiliac joint; the lower part of the connecting portion 104 is a cylindrical structure, which is used to connect with the anti-dislocation hip acetabulum prosthesis 2; the anti-dislocation hip acetabulum prosthesis 2 is a hemispherical acetabular socket structure.
半骨盆假体的髋臼旋转中心设计与术前CT病灶侧髋臼旋转中心贴合,通过假体关节面与骶骨耳状面的有效且唯一贴合,保证半骨盆假体的臼杯位置位于骨盆原髋臼旋转中心位置;防脱位髋关节臼杯假体2采用超半径双动结构,可有效避免内衬脱位,同时采用自锁设计聚乙烯卡扣预防假体球头脱位。The acetabulum rotation center of the hemi-pelvic prosthesis is designed to fit the acetabulum rotation center on the lesion side of the preoperative CT scan. The effective and unique fit between the prosthesis articular surface and the auricular surface of the sacrum ensures that the acetabulum of the hemi-pelvic prosthesis is located at the original acetabulum rotation center of the pelvis. The anti-dislocation hip acetabulum prosthesis 2 adopts an ultra-radius double-motion structure to effectively avoid liner dislocation, and a self-locking polyethylene buckle is used to prevent dislocation of the prosthesis ball head.
所述连接部104的下端设有自其下表面向上延伸形成的卡槽孔;所述防脱位髋关节臼杯假体2上部设有与卡槽孔相配合的圆柱形卡块。The lower end of the connecting portion 104 is provided with a slot hole extending upward from the lower surface thereof; the upper part of the anti-dislocation hip acetabulum prosthesis 2 is provided with a cylindrical block matching the slot hole.
所述假体内侧骶骨耳状面接触部102为3D打印多孔隙骨小梁结构,有助于骨长入,促进骨整合,利于远期假体骨界面愈合。The inner sacral ear-shaped surface contact portion 102 of the prosthesis is a 3D printed porous trabecular bone structure, which is helpful for bone ingrowth, promotes bone integration, and is beneficial to long-term prosthesis-bone interface healing.
所述骶骨耳状面接触部102上设有多组能够顺正常骨生物力学设计的螺纹孔a105;所述侧翼结构103上设有多组能够顺应正常骨生物力学设计的螺纹孔b 106,可按需用于臀大肌等软组织重建;所述骶髂关节面假体1上(骶骨耳状面接触部102与连接部104交界处)还设有多组能够按需固定万向钉6的螺纹孔c 107,通过腰骶连接杆7连接腰椎钉8,实现腰骶固定。The sacral ear-shaped surface contact portion 102 is provided with a plurality of threaded holes a105 that can conform to the normal bone biomechanical design; the flank structure 103 is provided with a plurality of threaded holes b106 that can conform to the normal bone biomechanical design, which can be used for soft tissue reconstruction such as gluteus maximus as needed; the sacroiliac joint surface prosthesis 1 (at the junction of the sacral ear-shaped surface contact portion 102 and the connecting portion 104) is also provided with a plurality of threaded holes c107 that can fix the universal nails 6 as needed, and the lumbar nails 8 are connected through the lumbar-sacral connecting rod 7 to achieve lumbar-sacral fixation.
所述通过骶骨螺钉5穿过螺纹孔a 105使假体固定在骶骨上;所述螺纹孔c107内能够个性化按需穿过万向钉6,万向钉6可通过尾帽固定腰骶连接杆7与腰椎钉8进行连接,实现假体与腰5椎体的连接(腰骶固定),螺钉方向皆为顺正常骨生物力学设计,减少螺钉剪切受力,增强假体植入后的牢固性。The prosthesis is fixed on the sacrum by passing the sacral screw 5 through the threaded hole a105; the threaded hole c107 can be personalized and required to pass the universal nail 6, the universal nail 6 can be fixed to the lumbar vertebrae 7 and the lumbar screw 8 through the tail cap to achieve the connection between the prosthesis and the lumbar vertebra 5 (lumbar sacral fixation), the direction of the screw is in accordance with the normal bone biomechanical design, reducing the shear force of the screw and enhancing the firmness of the prosthesis after implantation.
所述骶髂关节面假体1的连接部104与防脱位髋关节臼杯假体2设有可对齐的一组黑色短线109,对其后可预设防脱位髋关节臼杯假体2的前倾角和外展角分别为15°和40°,贴合人体生物力学功能。The connecting portion 104 of the sacroiliac joint surface prosthesis 1 and the anti-dislocation hip acetabulum prosthesis 2 are provided with a group of alignable black short lines 109, after which the anteversion angle and abduction angle of the anti-dislocation hip acetabulum prosthesis 2 can be preset to be 15° and 40° respectively, which fits the biomechanical function of the human body.
所述骶髂关节面假体1中的个各结构一体成型,上述结构通过计算机力学分析设计而成,可通过3D打印技术一体成型。Each structure in the sacroiliac joint surface prosthesis 1 is integrally formed. The above structure is designed through computer mechanics analysis and can be integrally formed through 3D printing technology.
本申请的防脱位髋关节臼杯假体能够实现假体精准安放,使髋臼选择中心重建在其生理解剖部位,同时减少术中骶骨螺钉植入风险,降低术后假体松动及断钉并发症的发生率,获得较好的髋关节功能和早期稳定性。The anti-dislocation hip acetabulum prosthesis of the present application can achieve precise placement of the prosthesis, allowing the acetabulum to be centrally reconstructed in its physiological anatomical position, while reducing the risk of sacral screw implantation during surgery, lowering the incidence of postoperative prosthesis loosening and screw breakage complications, and obtaining better hip joint function and early stability.
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