WO2018006429A1 - 髂骨修复体 - Google Patents

髂骨修复体 Download PDF

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Publication number
WO2018006429A1
WO2018006429A1 PCT/CN2016/089487 CN2016089487W WO2018006429A1 WO 2018006429 A1 WO2018006429 A1 WO 2018006429A1 CN 2016089487 W CN2016089487 W CN 2016089487W WO 2018006429 A1 WO2018006429 A1 WO 2018006429A1
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WO
WIPO (PCT)
Prior art keywords
rod
screw hole
screw
nail
seat
Prior art date
Application number
PCT/CN2016/089487
Other languages
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 PCT/CN2016/089487 priority Critical patent/WO2018006429A1/zh
Priority to US16/315,659 priority patent/US10828164B2/en
Priority to EP16907933.2A priority patent/EP3482720B1/en
Publication of WO2018006429A1 publication Critical patent/WO2018006429A1/zh

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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/30985—Designing or manufacturing processes using three dimensional printing [3DP]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30988—Other joints not covered by any of the groups A61F2/32 - A61F2/4425
    • A61F2002/30995—Other joints not covered by any of the groups A61F2/32 - A61F2/4425 for sacro-iliac joints
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0041—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using additional screws, bolts, dowels or rivets, e.g. connecting screws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0091—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type

Definitions

  • the present invention relates to the field of medical devices, and in particular to a tibial prosthesis.
  • the pelvis is a site of bone tumors, and pelvic tumors can be divided into primary tumors and metastatic tumors.
  • the former is mainly chondrosarcoma, osteosarcoma and Ewing sarcoma, the latter common in bone metastasis of breast cancer, kidney cancer, prostate cancer, lung cancer and the like.
  • the pelvic tumor is occult and difficult to diagnose early. It is often found that the scope of invasion is already large.
  • the anatomy around the pelvis is complicated and adjacent to many important organs. The operation is difficult, the complications are many, the curative effect is poor, and the mortality rate is high.
  • semi-pelvic resection or modified semi-pelvic resection amputation is mainly used for pelvic tumors.
  • the removal of any pelvic tumor will cause bone defects.
  • the bone defect will cause the patient's trunk and lower limbs to be continuously interrupted, affecting standing and weight-bearing walking, and the patient will not be able to bear the weight. And when walking, it will cause pain, and after the patient walks for a long time, the acetabulum will appear inward and upward. After the pelvis tilts, it causes scoliosis, which leads to a serious decline in the quality of life after surgery.
  • pelvic ring is composed of the humerus and the hip bones on both sides.
  • Each hip bone is composed of the humerus, ischium and pubic bone.
  • Extensive resection of pelvic tumors usually results in large bone defects, disrupting the continuity of the pelvis and losing some of the surrounding soft tissue.
  • the musculoskeletal tumor oncology group proposed the classification of pelvic tumor resection.
  • the type of surgery is divided into: type I ( ⁇ Bone resection); type II (acetabular resection); type III (obturator resection); type IV (involving resection of the tibia).
  • the resection type is a combination of the corresponding regions, such as the simultaneous removal of the tibia and acetabulum, the surgical type is type I and II; the entire pelvis is resected as type I, II, and III; Excision of the femoral head is H-type (such as II H; I, II H, II, III H).
  • Reconstruction of the pelvic ring after pelvic tumor resection is necessary to transmit the weight of the trunk to the lower extremities.
  • Reconstruction of the defected pelvis varies according to the surgeon's experience and patient's condition. Commonly used reconstruction methods include sacral surgery, hip displacement, bone fusion, structural allogeneic bone graft, artificial prosthesis and artificial leave. Body complex allograft.
  • the nail rod system has the following disadvantages: the nail rod in the nail rod system is easy to break, the fixing nail is easy to loose, the bone is easily damaged, and the patient is once again trapped. It is impossible to stand and walk, and life cannot be taken care of. Therefore, it is necessary to perform a fixed operation again. Moreover, the operation is difficult, the accuracy is very high, and a slight inadvertent operation can cause fatal bleeding or He has serious complications.
  • 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 humeral prosthesis comprising: a prosthetic body having an arched structure, the prosthetic body including a first end portion in contact with the tibia and a second end in contact with the acetabulum
  • the first end portion 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; the nail rod structure, the nail rod structure
  • the utility model comprises a connecting seat and a rod body, wherein the connecting seat is connected with the repairing body, the rod body is fixed on the connecting seat; the anti-off mechanism is disposed between the repairing body and the connecting seat, and the anti-off mechanism comprises and is received in the first screw The first anti-offset antenna of the screw fit in the hole.
  • the second end portion is provided with a second screw hole
  • the second screw hole is a tapered hole
  • the second screw hole is provided with a second nail seat
  • 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 portion is provided with a second screw hole
  • the second screw hole is a tapered hole
  • the second screw hole is provided with a second nail seat
  • the second nail seat has a spherical inner surface
  • first end and/or the second end are provided with a porous structure.
  • first end and/or the second end are provided with needle-like projections.
  • the surface of the repairing body facing the pelvis is a smooth surface.
  • 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 humeral prosthesis includes a prosthetic body including a first end portion in contact with the tibia and a second end portion in contact with the acetabulum.
  • the repairing body has an arched 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. Therefore, 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 tibia, and increases the stability of the tibia, thereby avoiding the sinking of the lumbar vertebrae.
  • the patella restoration includes a detachment prevention mechanism, and the detachment prevention mechanism includes a first anti-offset antenna that cooperates with a screw housed in the first screw hole, The above structure can prevent the screw from coming out of the first screw hole.
  • Figure 1 shows an assembled view of an angle of an embodiment of a tibial prosthesis according to the present invention
  • Figure 2 shows an assembled view of another angle of the tibial prosthesis of Figure 1.
  • Figure 3 is a perspective view showing the connection structure of the connecting base of the tibial prosthesis of Figure 1;
  • Figure 4 is a schematic longitudinal sectional view showing the connector of Figure 3;
  • Figure 5 is a perspective view showing the other structure of the connecting body of the tibial prosthesis of Figure 1;
  • Figure 6 is a schematic longitudinal sectional view showing the connector of Figure 5;
  • Figure 7 is a perspective view showing the structure of the tibia restoration of Figure 1 provided with a detachment prevention mechanism
  • Fig. 8 is a perspective view showing the structure of the detachment prevention mechanism of the tibia restoration of Fig. 7.
  • the patella prosthesis of the present embodiment includes a prosthetic body 10, a nail rod structure, and a detachment prevention mechanism 30.
  • the repairing body 10 has an arched structure, and the repairing body 10 includes a first end portion 11 in contact with the tibia 1 and a second end portion 12 in contact with the acetabulum 2, and the first end portion 11 is provided with a first screw
  • the first screw hole 111 is a tapered hole.
  • the first screw hole 111 is provided with a first nail base.
  • the first nail base has a spherical inner surface.
  • the nail rod structure includes a connecting base 22 and a rod body 23.
  • the connecting seat 22 is connected to the repairing body 10, and the rod body 23 is fixed on the connecting seat 22; the retaining mechanism 30, the retaining mechanism 30 is interposed between the repairing body 10 and the connecting seat 22, and the retaining mechanism 30 is included and accommodated in the first
  • a first anti-offset antenna 31 is fitted to the screw in the screw hole 111.
  • the patella restoration includes a repairing body 10 including a first end portion 11 in contact with the tibia 1 and a second end portion 12 in contact with the acetabulum.
  • the repairing body has an arched structure, has good mechanical properties, and improves the internal force distribution of the structure. Maintains the tibia with high stress and shear The stiffness of the restoration makes the bone less susceptible to damage. Therefore, 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 includes a connecting seat 22 and a rod body 23, and the connecting seat 22 is connected to the repairing body 10, and the rod body 23 is fixed on the connecting seat 22.
  • the above structure reinforces the fixation between the repairing body 10 and the tibia 1 and increases the stability of the tibia 1 thereby avoiding the sinking of the lumbar vertebrae.
  • the patella restoration further includes a detachment prevention mechanism 30, and the detachment prevention mechanism 30 includes a first detachment prevention antenna 31 that cooperates with a screw housed in the first screw hole 111, and the above structure can prevent The screw is released from the first screw hole 111.
  • 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, and the retaining mechanism 30 includes and is received in the first screw hole 111.
  • the first anti-offset antenna 31 of the screw fit.
  • the connecting seat 22 is screwed, and the first anti-offset antenna 31 is pressed against the screw received in the first screw hole 111.
  • the tighter the connecting screw 221 of the connecting seat 22 is, the force of the first anti-offset antenna 31 against the screw is The bigger. 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 nail bar structure further includes a connecting seat 21, the connecting seat 21 is connected with 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 tibia 1, 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 spherical shape matching the spherical nail head 2111. hole.
  • the above structure allows the rod fixing portion 212 to be rotatably provided 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 interposed 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 connecting seat 22 includes: a connecting screw 221 , one end of the connecting screw 221 is connected to the repairing body 10 , and the other end of the connecting screw 221 has a spherical nail head 2211; a rod fixing portion 222, To fix the rod 23, 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 10 is a hollow truss structure.
  • the truss structure can greatly reduce the quality of the repairing body 10, improve the material utilization rate, and at the same time ensure the repair.
  • using the above structure enables the repairing body 10 to be closer to the adjacent bones, thereby making Bone fusion works better. Because anatomical reconstruction after pelvic tumor resection requires not only accurate and complex requirements, but also needs to meet the requirements of one-time, tailor-made. Therefore, in the present embodiment, the repairing body 10 is formed by 3D printing. The above process itself is precise, capable of manufacturing complex parts and can be customized.
  • the 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 (AKYCM, AKYCdditive MAKYCnufAKYCcturing).
  • 3D printing technology uses three-dimensional CAKYCD 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 .
  • the first end portion 11 is provided with a first screw hole 111
  • the first screw hole 111 is a tapered hole
  • the first screw hole 111 is provided with a first nail seat
  • the first nail base has 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 tibia 1 is better.
  • the broken line in FIG. 1 is the direction in which the screw is inserted.
  • the second end portion 12 is provided with a second screw hole 121
  • the second screw hole 121 is a tapered hole
  • the second screw hole 121 is provided with a second nail seat
  • the second nail seat has a spherical inner surface.
  • the doctor can select the screw fixing position according to the actual situation, so that the fixing effect between the repairing body and the acetabulum 2 is better.
  • the first end portion 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 second end portion 12 is provided with a second porous structure (not shown).
  • the above structure can quickly promote osteogenesis and is easily integrated with bone (acetabulum) 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. Further, a muscle ligament fixing hole is provided on the curved long side surface of the second end portion 12.
  • the first end portion 11 is provided with a first acicular projection (not shown).
  • the first acicular projection has a function of cutting anchoring to fix the tibia 1 to the first end portion 11 of the prosthetic body 10.
  • the second end portion 12 is provided with a second acicular projection (not shown).
  • the second acicular projection has a cutting anchoring function to secure the acetabulum 2 to the second end portion 12 of the prosthetic body 10.
  • the surface of the repairing body 10 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 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 , and the retaining mechanism 30 further includes a second The anti-offset antenna 33, the first anti-offset antenna 31 and the second anti-offset antenna 33 are connected to the anti-off body 32 and extend outward.
  • the second anti-offset antenna 33 is provided with a limiting sleeve 34 that cooperates with the rod body 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 limiting sleeve 34 is disposed on the second anti-offset 33, the limiting sleeve 34 is engaged with the rod 23, so that the rod 23 is also prevented from rotating by the limit. The above structure prevents the rod 23 from rotating, 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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Surgery (AREA)
  • Neurology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurosurgery (AREA)
  • Prostheses (AREA)

Abstract

一种髂骨修复体，包括：修复主体(10)，修复主体(10)呈拱形结构，修复主体(10)包括与骶骨(1)接触配合的第一端部(11)以及与髋臼(2)接触配合的第二端部(12)，第一端部(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；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(10)连接，棒体(23)固定在连接座(22)上；防脱机构(30)，防脱机构(30)夹设在修复主体(10)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)。该技术方案能够有效地解决现有技术中的钉棒系统支撑不可靠，容易疲劳断裂的问题。

Description

髂骨修复体 技术领域
本发明涉及医疗器械领域，具体而言，涉及一种髂骨修复体。
背景技术
骨盆是骨肿瘤好发的部位，骨盆肿瘤可分为原发肿瘤和转移肿瘤。前者主要为软骨肉瘤、骨肉瘤和尤文肉瘤，后者常见于乳房癌、肾癌、前列腺癌、肺癌等的骨转移。骨盆肿瘤发病隐匿且早期诊断困难，往往发现时侵犯范围已经很大，加上骨盆周围解剖复杂并与很多重要脏器毗邻，手术难度大，并发症多，疗效欠佳，死亡率高。目前，对骨盆肿瘤主要采取半骨盆切除或改良半骨盆切除截肢术。但任何骨盆肿瘤的切除均会造成骨缺损，骨缺损会导致患者躯干和下肢连续性中断，影响站立和负重行走，患者将不能承担体重。并且行走的时候会产生疼痛，且患者长时间负重行走后，髋臼会出现内倾、上移。骨盆倾斜后会导致脊柱侧弯，导致患者术后生活质量严重下降。
二十世纪70年代以前，发生于骨盆区的恶性骨肿瘤大多数需要行骨盆切除术，传统的骨盆切除术是将病变骨盆与同侧下肢一并切除，因而造成了病人的严重残疾。随着化疗和放疗等辅助治疗方法的发展、先进影像手段的出现以及各类手术技术的提高，一些原来只能靠截肢才能治疗的肿瘤现在也可以施行保肢手术，大大减少了病人的残疾。目前，对80％以上的骨盆恶性肿瘤患者均行保肢治疗。
由于骨盆区解剖结构复杂，骨盆恶性骨肿瘤的保肢手术极具挑战性。骨盆环是由骶骨和两侧的髋骨组成，每侧髋骨由髂骨、坐骨和耻骨构成。骨盆肿瘤的广泛切除通常会造成较大的骨缺损，使骨盆的连续性中断，并损失周围的部分软组织。肌肉骨骼系统肿瘤协会提出了骨盆肿瘤切除术的分型，按解剖学部位(髂骨为I区，髋臼区为II区，闭孔区为III区)将手术类型分为：I型(髂骨切除)；II型(髋臼切除)；III型(闭孔区切除)；IV型(涉及骶骨的切除)。若同时切除两个或以上区域，则切除类型为相应区域的组合，如同时切除髂骨和髋臼区，则手术类型为I、II型；切除整个骨盆为I、II、III型；若同时切除股骨头，则为H型(如II H；I、II H，II、III H)。
骨盆肿瘤切除术后骨盆环的重建十分必要，这样可以将躯干的重量传导至下肢。对缺损的骨盆进行重建根据术者经验、患者情况不同手段各异，常用的重建方法有旷置术、髋关节移位术、骨融合术、结构性异体自体骨移植、人工假体及人工假体复合异体骨移植。
骶骨切除复合钉棒系统重建。上述重建方式短期能够达到承重的效果，但是从长期随访观察来看，钉棒系统具有下述缺点：钉棒系统中的钉棒容易断裂，固定钉容易松动，骨质容易受到破坏，患者再度陷入无法站立行走、生活无法自理的状态，因此必须再次实施固定手术。而且，该手术难度大，精准度要求非常高，术中稍有不慎，即可造成致命性大出血或其 他严重并发症。
发明内容
本发明旨在提供一种髂骨修复体，以解决现有技术中的钉棒系统支撑不可靠，容易疲劳断裂的问题。
为了实现上述目的，本发明提供了一种髂骨修复体，包括：修复主体，修复主体呈拱形结构，修复主体包括与骶骨接触配合的第一端部以及与髋臼接触配合的第二端部，第一端部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；钉棒结构，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；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，第二端部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，第二端部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，第一端部和/或第二端部设置有多孔结构。
进一步地，第一端部和/或第二端部设置有针状凸起。
进一步地，修复主体朝向盆腔的表面为光滑表面。
进一步地，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，髂骨修复体包括修复主体，修复主体包括与骶骨接触配合的第一端部以及与髋臼接触配合的第二端部。上述修复主体呈拱形结构，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，能够维持髂骨修复体的刚度，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系统支撑不可靠，容易疲劳断裂，最终导致骨质易受损坏的问题。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骶骨之间的固定，增加了骶骨的稳定性，从而避免了腰椎部位下沉。此外，应用本发明的技术方案，髂骨修复体包括防脱机构，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， 上述结构能够防止螺钉从第一螺钉孔内脱出。
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髂骨修复体的实施例的一个角度的装配示意图；以及
图2示出了图1的髂骨修复体的另一个角度的装配示意图。
图3示出了图1的髂骨修复体的连接座的立体结构示意图；
图4示出了图3的连接座的纵剖结构示意图；
图5示出了图1的髂骨修复体的另一个连接座的立体结构示意图；
图6示出了图5的连接座的纵剖结构示意图；
图7示出了图1的设置有防脱机构的髂骨修复体的立体结构示意图；以及
图8示出了图7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、骶骨；2、髋臼；10、修复主体；11、第一端部；111、第一螺钉孔；12、第二端部；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和图2和图7所示，本实施例的髂骨修复体包括修复主体10、钉棒结构以及防脱机构30。其中，修复主体10呈拱形结构，修复主体10包括与骶骨1接触配合的第一端部11以及与髋臼2接触配合的第二端部12，第一端部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；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10连接，棒体23固定在连接座22上；防脱机构30，防脱机构30夹设在修复主体10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。
应用本实施例的技术方案，髂骨修复体包括修复主体10，修复主体10包括与骶骨1接触配合的第一端部11以及与髋臼接触配合的第二端部12。上述修复主体呈拱形结构，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，能够维持髂骨 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系统支撑不可靠，容易疲劳断裂，最终导致骨质易受损坏的问题。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10连接，棒体23固定在连接座22上。上述结构加强了修复主体10与骶骨1之间的固定，增加了骶骨1的稳定性，从而避免了腰椎部位下沉。此外，应用本实施例的技术方案，髂骨修复体还包括防脱机构30，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，上述结构能够防止螺钉从第一螺钉孔111内脱出。
具体地，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，旋紧连接座22，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4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的一端与骶骨1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3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插入上述安装空间中。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6所示，在本实施例中，连接座22包括：连接螺钉221，连接螺钉221的一端与修复主体10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5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插入上述安装空间中。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。
如图1和图2所示，在本实施例中，修复主体10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10的质量，提高材料利用率，同时还能够保证修复主体10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10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，甚至于还需要满足一次性、量身定做的要求。因此，在本实施例中，修复主体10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(AKYCM，AKYCdditive MAKYCnufAKYCcturing)。3D打印技术是利用三维CAKYCD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系统因所用成型材料不同，成型原理和系统特点也各有差异，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和图2所示，第一端部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10通过螺钉固定在骶骨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，因此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，使得修复主体与骶骨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，第二端部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，使得修复主体与髋臼2之间的固定效果更佳。
在本实施例中，第一端部11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(骶骨)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，第二端部12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(髋臼)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。另外，在第二端部12的弧形长边面上设置有肌肉韧带固定孔。
在本实施例中，第一端部11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，以使骶骨1与修复主体10的第一端部11固定在一起。
在本实施例中，第二端部12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，以使髋臼2与修复主体10的第二端部12固定在一起。
在本实施例中，修复主体10朝向盆腔的表面为光滑表面(图中未示出)。上述结构能够减少髂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7和图8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。上述结构避免棒体23转动，从而增加了系统的稳定性。
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. 一种髂骨修复体，其特征在于，包括：
    修复主体(10)，所述修复主体(10)呈拱形结构，所述修复主体(10)包括与骶骨(1)接触配合的第一端部(11)以及与髋臼(2)接触配合的第二端部(12)，所述第一端部(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；
    钉棒结构，所述钉棒结构包括连接座(22)以及棒体(23)，所述连接座(22)与所述修复主体(10)连接，所述棒体(23)固定在所述连接座(22)上；
    防脱机构(30)，所述防脱机构(30)夹设在所述修复主体(10)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)。
  2. 根据权利要求1所述的髂骨修复体，其特征在于，所述第二端部(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所述的髂骨修复体，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(10)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所述的髂骨修复体，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所述的髂骨修复体，其特征在于，所述修复主体(10)为中空桁架结构，所述修复主体(10)通过3D打印成型。
  6. 根据权利要求1所述的髂骨修复体，其特征在于，所述第二端部(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。
  7. 根据权利要求1所述的髂骨修复体，其特征在于，所述第一端部(11)和/或所述第二端部(12)设置有多孔结构。
  8. 根据权利要求1所述的髂骨修复体，其特征在于，所述第一端部(11)和/或所述第二端部(12)设置有针状凸起。
  9. 根据权利要求1所述的髂骨修复体，其特征在于，所述修复主体(10)朝向盆腔的表面 为光滑表面。
  10. 根据权利要求1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(10)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)。
PCT/CN2016/089487 2016-07-08 2016-07-08 髂骨修复体 WO2018006429A1 (zh)

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