WO2014079178A1 - 颌骨修复体 - Google Patents
颌骨修复体 Download PDFInfo
- Publication number
- WO2014079178A1 WO2014079178A1 PCT/CN2013/072619 CN2013072619W WO2014079178A1 WO 2014079178 A1 WO2014079178 A1 WO 2014079178A1 CN 2013072619 W CN2013072619 W CN 2013072619W WO 2014079178 A1 WO2014079178 A1 WO 2014079178A1
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- WO
- WIPO (PCT)
- Prior art keywords
- jaw
- physiological
- restoration
- bone
- tendon
- Prior art date
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Classifications
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- 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
- A61F2/28—Bones
- A61F2/2803—Bones for mandibular reconstruction
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- 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
- A61F2/28—Bones
- A61F2/2875—Skull or cranium
-
- 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
- A61F2/28—Bones
- A61F2/2875—Skull or cranium
- A61F2002/2889—Maxillary, premaxillary or molar implants
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- 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
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2002/3092—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having an open-celled or open-pored structure
Definitions
- the present invention relates to the field of medical restoration prostheses, and in particular to a jaw restoration.
- BACKGROUND OF THE INVENTION Craniomaxillofacial mandibular defects are more common in clinical cases. Maxillofacial cysts and tumors, acute and chronic jaw osteomyelitis, radiation osteonecrosis, severe trauma, infection, and congenital inheritance can cause partial or complete removal or loss of the mandible, resulting in discontinuation of bone structure continuity, and more Associated with defects in adjacent soft tissues. Jaw defects seriously affect the patient's physical function such as language, breathing, chewing, swallowing and facial beauty, which seriously deteriorates the quality of life of patients.
- the commonly used methods for the treatment of jaw defects include autologous bone grafting, allogeneic bone grafting, traction osteogenesis and bone tissue engineering techniques, but there are still problems such as poor filling and sealing of the defect position, poor retention, etc. Shape and appearance recovery and matching are difficult to achieve ideal reconstruction.
- metal rapid manufacturing technology has been used to establish a three-dimensional skeleton model of a defect site through CT scan data, and a method for directly repairing a prosthesis by directly processing a metal material by a CNC metal cutting machine tool such as a machining center has solved the initial fixation problem to some extent, but the long-term problem The combination of hard tissue and soft tissue adhesion of the muscle ligament group is still not ideal.
- the present invention is directed to a mandible prosthesis to solve the problem that the jaw repair technique in the prior art is difficult to reconstruct the shape and the bone of the jaw prosthesis, and the filling position of the defect is not ideal, and the retention is poor.
- the problem and the long-term hard tissue bonding effect of the prosthesis directly processed with metal are not ideal.
- the present invention provides a jaw restoration which is disposed at a position where a patient lacks a physiological jaw to replace a physiological jaw, and includes: a jaw restoration body having the same shape as a physiological jaw; a bone fusion surface, setting The surface of the jaw restoration is combined with the adjacent physiological bone; the bone fusion surface has a microporous structure for the growth of bone cells.
- the jaw repair body includes a maxillary prosthesis body and/or a mandibular prosthesis body.
- the maxillary prosthesis body includes part or all of one or more structures in the physiological upper jaw region, the nasal anterior spine, the lower eyelid margin, and the condyle structure.
- the mandible repair body includes part or all of one or more structures in the physiological lower jaw region, the mandibular body, the mandibular angle, the mandibular ascending branch, the coronoid process, and the condyle.
- the jaw restoration body is integrally formed.
- the method further comprises: a tendon or a soft tissue attachment region disposed on a surface of the jaw restoration body that is connected to the starting point and the end point of the physiological ligament, and the tendon or soft tissue attachment region has a microporous structure for the growth of the physiological tendon or the soft tissue cell. .
- a tendon-locking hole is provided inside and/or around the tendon or soft tissue attachment region.
- the jaw restoration body is provided with a connecting protrusion having an overhanging screw hole for connecting with the adjacent physiological bone through the mounting screw.
- the method further includes: fixing the steel plate; the main body of the jaw is provided with a fixed steel plate screw hole, and one end of the fixed steel plate is connected to the fixed steel plate screw hole by a mounting screw, and the other end of the fixed steel plate is connected with the adjacent physiological bone.
- a dental implant abutment fixing hole for mounting the dental implant is further disposed on the main body of the jaw repair corresponding to the alveolar ridge.
- a through hole for a nerve or a blood vessel bundle is provided on the main body of the jaw restoration.
- the skeletal body of the jaw restoration and the patient are highly similar in shape, fully filling the position of the closed defect, and the position is well fixed; and, the bone fusion surface for facilitating the growth of the bone cells is provided, Conducive to long-term bone fusion of the prosthesis and physiological bone.
- Fig. 1 shows a schematic view of a jaw restoration of the present invention
- Fig. 2 shows a schematic view of a maxillary prosthesis body in a jaw restoration of the present invention
- Fig. 3 is a schematic view showing the first direction of the mandible repairing body in the jaw restoration of the present invention.
- FIG. 4 is a schematic view showing the second direction of the mandible repairing body in the jaw restoration of the present invention.
- Fig. 5 is a view showing the combination of the mandibular prosthesis body and the physiological bone in the jaw restoration of the present invention.
- Fig. 6 is a schematic view showing the provision of an overhanging screw hole in the jaw restoration of the present invention.
- Fig. 7 is a view showing the installation of a fixed steel plate in the jaw restoration of the present invention.
- Figure 8 shows a first embodiment of a partial mandible of a jaw restoration of the present invention.
- Figure 9 shows a second embodiment of a mandible restoration of the present invention comprising a portion of the mandible.
- the present invention provides a jaw restoration, comprising a maxillary prosthesis body 10 and a mandible restoration body 20; the jaw restoration body has a bone fusion surface 30, a dental implant abutment fixing hole 40, The tendon or soft tissue attachment area 50, the tendon locking hole 60, the through hole 70, and the overhanging screw hole 80.
- the main body of the jaw restoration is based on the CT and MRI scan data of the part to be repaired and the surrounding tissue that the patient needs to fill.
- the three-dimensional model is reconstructed by computer software and the jaw restoration is completely conformed to the individual anatomy.
- Metal rapid prototyping techniques such as Electron Beam Melting (EMM) or Selective Laser Sintering (SLS) are quickly processed into a very accurate geometrically accurate jaw restoration by computer control.
- the necessary subsequent processing such as drilling, tapping, surface treatment, assembly, etc., becomes a product that can be directly implanted into the human body.
- the main body of the jaw repair of the present invention is made of medical metal, including medical stainless steel, titanium and titanium-based alloy, cobalt-based alloy, etc., and such medical metal materials have proven their good biological properties in clinical practice for many years.
- the coverage of the maxillary prosthesis body 10 may include the upper jaw region, and if necessary, extend to some or all of the structures of the anterior nasal spine, the lower eyelid, and the condyle according to the bone defect.
- the coverage of the mandibular prosthesis 20 may include some or all of the structures of the lower jaw region, the mandibular body, the mandibular angle, the mandibular ascending branch, the coronoid process, and the condyle.
- the maxillary prosthesis body 10 has a structure in which the upper jaw region, the anterior nasal spine, the lower eyelid margin, and the condyle are integrally formed.
- the mandible repair body 20 has a structure in which the lower jaw region, the mandibular body, the mandibular angle, the mandibular ascending branch, the coronoid process, and the condyle are integrally formed.
- the interface of the maxillary prosthesis body 10, the mandibular prosthesis body 20 and the adjacent physiological bone to be joined is referred to as a bone fusion surface 30, which has a microporous structure.
- the microporous structure is a multi-directional microporous structure with surface porosity and internal interconnection, which is favorable for bone cell creeping and long, and the bone fusion surface 30 on the artificial prosthesis will be bone with the physiological bone structure. Fusion to achieve long-term stability.
- the maxillary prosthesis body 10 is provided with a tendon or soft tissue attachment region 50 corresponding to the starting and ending points of each maxillary physiological ligament, and the tendon or soft tissue attachment region 50 is a porous region for physiological tendon and Soft tissue cells wrap around to provide a reliable focus for future free movement of the jaw muscles.
- the porous area has a pore size of 0.25 mm to 3 mm; these tendon or soft tissue attachment areas include: a bite located at the lower edge of the condyle and the zygomatic arch Muscle attachment zone 54; pterygoid attachment zone 55 located in the vertebral process and maxillary nodules; located in the genioglossus attachment zone 510 of the sacral spine; the iliac muscle attachment zone 51 in front of the sacral sulcus; located in the maxilla
- the mandible repair body 20 is provided with a tendon or soft tissue attachment region 50 corresponding to the start and end points of each mandibular physiological ligament, and the tendon or soft tissue attachment region 50 is a three-dimensional connected pore.
- the porous area provides a reliable focus for the movement of physiological tendons and soft tissue cells to provide free movement for future maxillofacial muscle groups.
- the porous region of the three-dimensional connected pores has a pore diameter of 0.25 mm to 3 mm ; these tendon or soft tissue attachment areas include : the disc and the temporomandibular ligament attachment area located on the posterior aspect of the condyle; the sagittal mandibular ligament attachment zone located at the posterior margin of the mandibular angle and the mandibular branch; and the descending labial muscle of the descending mandible of the mandible 59; the diaphragmatic attachment area 58 located at the apex of the mandibular lateral incisor; the masseteric attachment area 54 located in the mandibular masseter trochanter; the diaphragmatic attachment area 57 located at the anterior border of the mandibular condyle; located in the mandibular wing The pterygoid muscle attachment zone 55; the extra-pterymal attachment zone 56 located on the lateral side of the mandibular wing outer panel
- the maxillary prosthesis main body 10 and the mandibular prosthesis main body 20 are provided with an overhanging screw hole 80 in the vicinity of the bone fusion surface 30 combined with the adjacent physiological bone to be engaged, and the protruding screw hole 80 is provided. Cover the surface of adjacent physiological bones.
- the post-operative initial maxillary prosthesis body 10 and the mandibular prosthesis body 20 are fixed to the adjacent physiological bone by screws passing through the overhanging screw hole 80, so as to facilitate the later repair of the main body 10 and the mandible repair body 20 with the maxilla.
- the physiological bone cells of the bone fusion surface binding site crawl and grow into the pores of the bone fusion surface 30 to form a firm connection. Referring to Fig.
- the maxillary prosthesis body 10 and the mandibular prosthesis body 20 are provided with fixing plate screw holes 91 in the vicinity of the bone fusion surface 30 which is joined to the adjacent physiological bone to be engaged.
- the maxillary prosthesis main body 10 and the mandibular prosthesis main body 20 are fixed by the conventional type of fixed steel plate 90 and the adjacent physiological bones, so as to facilitate the bone grafting to the bone fusion surface 30 at the bone fusion surface bonding site in the future.
- the inside of the micropore crawls and grows into a firm connection. As shown in FIG. 5 to FIG.
- the maxillary prosthesis main body 10 and the mandibular repair main body 20 are respectively provided with the dental implant abutment fixing holes 40 (for example, one, a plurality, and up to 16).
- the implant base 40 can be implanted in the implant abutment fixing hole 40, and the implant crown 42 can be mounted on the implant base 41 for realizing the function of the physiological tooth through the implant.
- the maxillary prosthesis body 10 is provided with through holes 70 in the vicinity of the position corresponding to the physiological maxillary submental hole for the purpose of passing through the infraorbital nerve and the blood vessel bundle, and the through hole 70 is one or more.
- the mandible repair body 20 is provided with a through hole 70 in the vicinity of the position corresponding to the physiological mandibular pupil for respectively passing through the mandibular nerve and the blood vessel bundle, and the through hole 70 is one or more.
- the tendon-locking hole 60 is provided in the region of the tendon or the soft tissue attachment region of the jaw repairing body for suspending the tendon or soft tissue during the operation to facilitate the posterior tendon to the tendon or soft tissue attachment region 50.
- the inside of the micropore crawls and grows into a firm connection.
- the region of the jaw restoration body other than the tendon or soft tissue attachment region 50 is a smooth surface. Referring to Fig.
- a jaw restoration of a first embodiment of the present invention including a maxillary prosthesis body 10 for repairing a portion of the maxilla.
- a jaw restoration of a second embodiment of the present invention including a mandible restoration body 20 for repairing a portion of the mandible.
- a design, fabrication and surgical procedure of the jaw restoration of the present invention is:
- EMM Electron Beam Melting
- SLS Selective Laser Sintering
- the mandibular prosthesis is implanted, and the maxillary prosthesis and the mandibular prosthesis are implanted into the corresponding predetermined positions according to the prior surgical plan, so that the bone fusion surface and the adjacent physiological bone tissue joint surface to be joined closely fit.
- Pass The mandibular prosthesis is fixed to the adjacent physiological bone by using a bone screw through the overhanging screw hole, and the jaw restoration can be fixed with the adjacent physiological bone using a conventional maxillofacial fixed plate.
- the microporous structure of the bone fusion surface of the jaw restoration is closely contacted with the adjacent host physiological bone, and the bone cells will grow into the microporous structure on the surface of the jaw restoration. Good bone fusion is formed; in addition, soft tissue such as physiological tendon ligament which is sutured and fixed to each tendon or soft tissue attachment zone will also surround the growth site of the tendon or soft tissue to form the movement point of the jaw muscle group.
- the processing path of a mandibular prosthesis is melt-molded by rapid prototyping techniques such as laser sintering or high-energy electron beam melting.
- the specific methods are as follows: a) Obtaining tomographic data of the patient's maxillofacial region by CT or MRI scan, and according to the tomographic scan The data reversely establishes a three-dimensional model of the jaw restoration. b) using professional software to layer the three-dimensional data model of the jaw restoration component designed and built in the computer to obtain the contour data of a series of single-layer slices; c) input the above-mentioned series to the laser or high-energy electron beam rapid prototyping equipment Sheet data; d) laying a medical metal powder of a corresponding thickness in the processing chamber of a laser or high-energy electron beam rapid prototyping apparatus with a layered height of the aforementioned three-dimensional data model; e) controlling the laser beam or high-energy electron beam to the medical metal powder by a computer Scanning and selective melting; 0 repeating the aforementioned laying of the powder, scanning the melting step to fuse the layers of the selected melted material to each other; g) removing the unmelted powder after
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- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Vascular Medicine (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
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- Orthopedic Medicine & Surgery (AREA)
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Abstract
一种颌骨修复体,设置在患者缺失生理颌骨的位置替代生理颌骨,包括与生理颌骨形状相同的颌骨修复主体和设置在颌骨修复主体与相邻接的生理骨结合的面上的骨质融合面(30)。所述骨质融合面具有微孔结构以供骨细胞长入。由于所述颌骨修复主体与患者缺失的生理骨在形态上高度相似,能够充分且牢固地填充封闭缺损位置;骨质融合面(30)有利于修复体与生理骨的长期骨融合。
Description
颌骨修复体 技术领域 本发明涉及医学修复假体领域, 具体而言, 涉及一种颌骨修复体。 背景技术 颅颌面上下颌骨缺损在临床病例中较为常见。 颌面部囊肿及肿瘤、 急慢性颌骨骨 髓炎、 放射性骨坏死、 严重的外伤、 感染、 以及先天性遗传等疾病会导致下颌骨部分 或全部切除或丧失, 使得骨结构连续性中断, 且多伴有相邻软组织的缺损。 颌骨缺损 严重影响患者的语言、 呼吸、 咀嚼、 吞咽以及面部美观等生理功能, 使患者的生活质 量严重下降。 目前, 临床常用的颌骨缺损治疗方法包括自体骨移植、 同种异体骨移植、 牵引成 骨技术及骨组织工程技术等, 但仍存在缺损位置填充封闭不理想, 固位差等问题, 且 塑形及容貌恢复与匹配很难达到理想重建。 近来也有采用金属快速制造技术通过 CT 扫描数据建立缺损部位三维骨骼模型并通过加工中心等数控金属切削机床对金属材料 直接加工成型修复假体的方法, 一定程度上解决了初期固定问题, 但远期硬组织结合 以及肌肉韧带群软组织附着效果仍不理想。 发明内容 本发明旨在提供一种颌骨修复体, 以解决现有技术中的颌骨修复技术难以理想重 建形状与生理骨符合的颌骨假体, 存在缺损位置填充封闭不理想, 固位差的问题以及 用金属直接加工的修复假体的远期硬组织结合效果不理想的问题。 为了实现上述目的, 本发明提供了一种颌骨修复体, 设置在患者缺失生理颌骨的 位置替代生理颌骨, 包括: 颌骨修复主体, 与生理颌骨形状相同; 骨质融合面, 设置 在颌骨修复主体与相邻接的生理骨结合的面上; 骨质融合面具有微孔结构以供骨细胞 长入。 进一步地, 颌骨修复主体包括上颌骨修复主体和 /或下颌骨修复主体。 进一步地, 上颌骨修复主体包括生理上牙颌区、 鼻前棘、 眼眶下缘、 颧突结构中 一个或多个结构的部分或全部。
进一步地, 下颌骨修复主体包括生理下牙颌区、 下颌体、 下颌角、 下颌升支、 冠 突、 髁突中一个或多个结构的部分或全部。 进一步地, 颌骨修复主体一体成型。 进一步地, 还包括, 肌腱或软组织附着区, 设置在颌骨修复主体上与生理韧带起 点和止点相接的面上, 肌腱或软组织附着区具有微孔结构以供生理肌腱或软组织细胞 长入。 进一步地, 肌腱或软组织附着区的内部和 /或周边设置有肌腱锁合孔。 进一步地, 颌骨修复主体上设置有具有外伸螺钉孔的连接凸柱, 用于通过安装螺 钉与邻接的生理骨连接。 进一步地, 还包括, 固定钢板; 颌骨修复主体上设置有固定钢板螺钉孔, 固定钢 板的一端通过安装螺钉与固定钢板螺钉孔连接, 固定钢板的另一端与邻接的生理骨连 接。 进一步地, 还包括用于安装种植牙的种植牙基台固定孔, 设置在颌骨修复主体上 对应牙槽嵴的部位。 进一步地, 颌骨修复主体上设置有用以穿过神经或血管束的贯通孔。 应用本发明的技术方案, 颌骨修复体与患者所缺失的生理骨在形态上高度相似, 充分填充封闭缺损位置, 位置固定良好; 并且, 设置了便于骨细胞长入的骨质融合面, 有利于修复体与生理骨的长期骨融合。 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示出了本发明的颌骨修复体的示意图; 图 2示出了本发明的颌骨修复体中的上颌骨修复主体的示意图。 图 3示出了本发明的颌骨修复体中的下颌骨修复主体的第一方向的示意图。 图 4示出了本发明的颌骨修复体中的下颌骨修复主体的第二方向的示意图。
图 5示出了本发明的颌骨修复体中的下颌骨修复主体与生理骨的结合示意图。。 图 6示出了本发明的颌骨修复体中设置外伸螺钉孔的示意图。 图 7示出了本发明的颌骨修复体中设置固定钢板的安装示意图。 图 8示出了本发明的颌骨修复体的包含部分上颌骨的第一实施例。 以及 图 9示出了本发明的颌骨修复体的包含部分下颌骨的第二实施例。 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。 参见图 1所示,本发明提供了一种颌骨修复体,包括上颌骨修复主体 10和下颌骨 修复主体 20; 颌骨修复主体上具有骨质融合面 30、 种植牙基台固定孔 40、 肌腱或软 组织附着区 50、 肌腱锁合孔 60、 贯通孔 70、 外伸螺钉孔 80。 颌骨修复主体是根据患者需填补的待修复部位及其周边组织的 CT、 MRI等扫描 数据, 通过计算机软件逆向重建三维模型并依此设计出完全符合个体解剖学形态的颌 骨修复体, 应用金属快速成型技术例如电子束熔融成型技术 (Electron Beam Melting, EBM) 或者选择性激光烧结技术 (Selected Laser Sintering, SLS) 在计算机控制下快 速加工成几何尺寸非常精确的颌骨修复体毛坯, 再经必要的后续加工例如钻孔、 攻螺 纹、 表面处理、 组装等成为可以直接植入人体的产品。 本发明的颌骨修复主体采用医用金属, 包括医用不锈钢、 钛及钛基合金、 钴基合 金等材料制成,这类医用金属材料都已经过多年临床实践证实了其良好的生物学性能。 参见图 2所示, 上颌骨修复主体 10的涵盖范围可包括上牙颌区, 必要时按骨缺损 情况扩展到鼻前棘、 眼眶下缘、 颧突等结构的部分或全部。 参见图 3所示,下颌骨修复主体 20的涵盖范围可包括下牙颌区、下颌体、下颌角、 下颌升支、 冠突、 髁突等结构的部分或全部。 优选地, 上颌骨修复主体 10其上牙颌区、 鼻前棘、 眼眶下缘、颧突等结构一体成 型。 下颌骨修复主体 20其下牙颌区、 下颌体、 下颌角、 下颌升支、 冠突、 髁突等结构 一体成型。
上颌骨修复主体 10、 下颌骨修复主体 20与相邻欲衔接的生理骨结合的界面称为 骨质融合面 30, 该骨质融合面具有微孔结构。 该微孔结构是一种表面多孔隙, 内部相 互连通的多向微孔隙结构, 该孔隙有利于骨细胞爬行长入, 术后人工修复体上的骨质 融合面 30将与生理骨结构发生骨融合以达到长期稳定。 参见图 2所示,优选地, 上颌骨修复主体 10在对应于各上颌生理韧带起点和止点 设有肌腱或软组织附着区 50, 肌腱或软组织附着区 50为一多孔区域以供生理肌腱与 软组织细胞包绕长入以给未来颌骨肌群自如的运动提供可靠的着力点, 多孔区域其孔 径为 0.25mm至 3mm; 这些肌腱或软组织附着区包括: 位于颧突和颧弓下缘的咬肌附 着区 54; 位于椎突和上颌结节的翼内肌附着区 55 ; 位于颏棘的颏舌肌附着区 510; 位 于颧骨颧颞缝前方的颧大肌附着区 51 ; 位于上颌骨眶下缘的提上唇肌附着区; 位于上 颌骨额突的提上唇鼻翼肌附着区 52; 位于上颌骨尖牙窝的提口角肌附着区 53。 参见图 3至图 5所示,优选地, 下颌骨修复主体 20在对应于各下颌生理韧带起点 和止点设有肌腱或软组织附着区 50, 肌腱或软组织附着区 50为一具有三维连通孔隙 的多孔区域供生理肌腱与软组织细胞包绕长入以给未来颌面部肌群自如的运动提供可 靠的着力点, 三维连通孔隙的多孔区域其孔径为 0.25mm至 3mm; 这些肌腱或软组织 附着区包括: 位于髁突后斜面与外侧面的关节盘以及颞下颌韧带附着区; 位于下颌角 与下颌支后缘的茎突下颌韧带附着区; 位于下颌骨外斜线的降下唇肌降口角肌附着区 59; 位于下颌骨侧切牙根尖处骨面的颏肌附着区 58; 位于下颌骨咬肌粗隆的咬肌附着 区 54; 位于下颌支喙突前缘的颞肌附着区 57; 位于下颌骨翼肌粗隆的翼内肌附着区 55; 位于下颌骨翼外板外侧面的翼外肌附着区 56。 参见图 6所示, 优选地, 上颌骨修复主体 10、 下颌骨修复主体 20在与欲衔接之 相邻生理骨结合的骨质融合面 30附近设有外伸螺钉孔 80, 外伸螺钉孔 80覆盖在相邻 生理骨表面。 术后初期上颌骨修复主体 10与下颌骨修复主体 20通过穿过外伸螺钉孔 80内的螺钉与相邻生理骨结合固定, 以利于日后在与上颌骨修复主体 10、下颌骨修复 主体 20的骨质融合面结合部位的生理骨骨细胞向骨质融合面 30的微孔内部爬行长入 形成牢固的连接。 参见图 7所示, 优选地, 上颌骨修复主体 10、 下颌骨修复主体 20在与欲衔接之 相邻生理骨结合的骨质融合面 30附近设有固定钢板螺钉孔 91。 术后初期上颌骨修复 主体 10、 下颌骨修复主体 20通过常规类型的固定钢板 90与相邻生理骨结合固定, 以 利于日后生理骨在骨质融合面结合部位骨细胞向骨质融合面 30 的微孔内部爬行长入 形成牢固的连接。
参见图 5至图 8所示, 优选地, 上颌骨修复主体 10、 下颌骨修复主体 20对应牙 槽嵴部位分别设置种植牙基台固定孔 40 (例如设置 1个、 多个直至 16个)。 该种植牙 基台固定孔 40内可以植入种植牙基台 41,在种植牙基台 41上安装种植牙牙冠 42,用 于通过种植牙实现生理牙的功能。 优选地,上颌骨修复主体 10在对应生理上颌骨眶下孔位置附近按左右分别设有贯 通孔 70以备需要时用以穿过眶下神经及血管束, 贯通孔 70为一个或多个。 优选地,下颌骨修复主体 20在对应生理下颌骨颏孔位置附近按左右分别设有贯通 孔 70以备需要时用以穿过下颌神经及血管束, 贯通孔 70为一个或多个。 优选地,颌骨修复主体肌腱或软组织附着区内及周边设置有肌腱锁合孔 60用以在 手术中使用缝合线对肌腱或软组织进行临时固定, 以利于日后肌腱向肌腱或软组织附 着区 50的微孔内部爬行长入形成牢固的连接。 优选地, 颌骨修复主体除肌腱或软组织附着区 50以外的其他区域为光滑表面。 参见图 8所示, 图中示出了本发明的第一实施例的颌骨修复体, 包括修复上颌骨 一部分的上颌骨修复主体 10。 参见图 9所示, 图中示出了本发明的第二实施例的颌骨修复体, 包括修复下颌骨 一部分的下颌骨修复主体 20。 本发明的颌骨修复体的一种设计、 制作及手术过程为:
1. 术前对患者颌面部进行 CT、 MRI检查以获取患处数据建立三维模型, 当一侧 部位数据缺失时可使用镜像方法将对侧骨数据翻转复制过来, 通过计算机辅助设计软 件设计出能够恢复患者理想容貌形态的颌骨修复体, 在颌骨修复体相应部位设计出与 欲衔接之相邻生理骨组织结合的骨质融合面、 种植牙基台固定孔、 肌腱或软组织附着 区、 肌腱锁合孔、 贯通孔、 固定钢板螺钉孔、 外伸螺钉孔。
2. 应用金属快速成型技术如电子束熔融成型技术 (Electron Beam Melting, EBM) 或者选择性激光烧结技术 (Selected Laser Sintering, SLS)在计算机控制下快速加工成 几何尺寸非常精确的颌骨修复体毛坯, 再经必要的后续加工例如钻孔、 攻螺纹、 表面 处理、 组装等成为可以直接植入人体的产品。
3. 行颌骨修复体植入手术,将上颌骨修复主体、下颌骨修复主体按照事先手术规 划植入相应预定位置, 使骨质融合面与欲衔接之相邻生理骨组织结合面紧密贴合, 通
过外伸螺钉孔使用骨螺钉将颌骨修复体与相邻生理骨进行固定, 也可以使用常规颌面 部固定钢板将颌骨修复体与相邻生理骨进行固定。
4. 将专用于接驳离断神经的胶原蛋白神经鞘管分别穿过上颌骨修复主体和下颌 骨修复主体上的贯通孔, 并将受损被离断于颌骨内外两侧的颌面部神经断端插接入相 应胶原蛋白神经鞘管端口用缝线结扎缝合, 受损神经将有可能在胶原蛋白神经鞘管保 护下不受外周其他组织的干扰而沿着胶原蛋白神经鞘管内部的管道生长修复。
5. 将需附着固定的肌腱韧带等软组织用缝合线缝固在相对应的肌腱或软组织附 着区。
6. 关闭创口, 常规术后处理与护理。 颌骨修复体被植入后该颌骨修复体骨质融合面的微孔结构与相邻宿主生理骨骨质 紧密接触贴合,未来骨细胞将长入颌骨修复体表面的微孔结构而形成良好的骨性融合; 此外被缝合固定于各个肌腱或软组织附着区的生理肌腱韧带等软组织亦将包绕生长入 肌腱或软组织附着区以形成颌骨肌群的运动着力点。 一种颌骨修复体的加工路径为利用激光烧结或高能电子束熔融等快速成型技术熔 融成型, 具体方法如下: a) 通过 CT或 MRI扫描获得患者颌面部的断层扫描数据, 并依据断层扫描数 据逆向建立颌骨修复体的三维模型。 b) 使用专业软件对在计算机中设计建造的颌骨修复体部件三维数据模型进行 分层, 以获得一系列单层切片的轮廓数据; c) 向激光或高能电子束快速成型设备输入上述系列层片数据; d) 在激光或高能电子束快速成型设备加工舱内铺设与前述三维数据模型分层 时层高相应厚度的医用金属粉末; e) 由计算机控制激光束或高能电子束对医用金属粉末进行扫描并有选择的熔 化; 0 重复前述铺设粉末、 扫描熔化步骤以使各层被选择熔化的材料相互熔结成 整体;
g ) 完成全部层面的熔融过程后去除未熔融的粉末即可得到所需要形状结构的 颌骨修复体部件; h)由于在建造颌骨修复体部件三维数据模型时已经将所需要的实体、 孔洞、微 孔等等结构一并设计在数据文件中, 因此上述各种结构在激光烧结或高能电子束熔融 过程中将一次性完成制造; 从以上的描述中, 可以看出, 本发明上述的实施例实现了如下技术效果:。 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
1. 一种颌骨修复体, 设置在患者缺失生理颌骨的位置替代所述生理颌骨, 其特征 在于, 包括:
颌骨修复主体, 与所述生理颌骨形状相同;
骨质融合面 (30),设置在所述颌骨修复主体与相邻接的生理骨结合的面上; 所述骨质融合面 (30) 具有微孔结构以供骨细胞长入。
2. 根据权利要求 1所述的颌骨修复体, 其特征在于, 所述颌骨修复主体包括上颌 骨修复主体 (10) 和 /或下颌骨修复主体 (20)。
3. 根据权利要求 2所述的颌骨修复体, 其特征在于, 所述上颌骨修复主体 (10) 包括生理上牙颌区、 鼻前棘、 眼眶下缘、 颧突结构中一个或多个结构的部分或 全部。
4. 根据权利要求 2所述的颌骨修复体, 其特征在于, 所述下颌骨修复主体 (20) 包括生理下牙颌区、 下颌体、 下颌角、 下颌升支、 冠突、 髁突中一个或多个结 构的部分或全部。
5. 根据权利要求 1至 4中任意一项所述的颌骨修复体, 其特征在于, 所述颌骨修 复主体一体成型。
6. 根据权利要求 1所述的颌骨修复体, 其特征在于, 还包括, 肌腱或软组织附着 区(50), 设置在所述颌骨修复主体上与生理韧带起点和止点相接的面上, 所述 肌腱或软组织附着区 (50) 具有微孔结构以供生理肌腱或软组织细胞长入。
7. 根据权利要求 6所述的颌骨修复体,其特征在于,所述肌腱或软组织附着区 (50) 的内部和 /或周边设置有肌腱锁合孔 (60)。
8. 根据权利要求 1所述的颌骨修复体, 其特征在于, 所述颌骨修复主体上设置有 具有外伸螺钉孔 (80) 的连接凸柱, 用于通过安装螺钉与邻接的生理骨连接。
9. 根据权利要求 1所述的颌骨修复体, 其特征在于, 还包括, 固定钢板(90); 所 述颌骨修复主体上设置有固定钢板螺钉孔(91 ), 所述固定钢板(90) 的一端通 过安装螺钉与所述固定钢板螺钉孔 (91 ) 连接, 所述固定钢板 (90) 的另一端 与邻接的生理骨连接。
10. 根据权利要求 1所述的颌骨修复体, 其特征在于, 还包括用于安装种植牙的种 植牙基台固定孔 (40), 设置在所述颌骨修复主体上对应牙槽嵴的部位。
11. 根据权利要求 1所述的颌骨修复体, 其特征在于, 所述颌骨修复主体上设置有 用以穿过神经或血管束的贯通孔 (70)。
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CN102920535B (zh) * | 2012-11-26 | 2014-07-23 | 北京爱康宜诚医疗器材股份有限公司 | 颌骨修复体 |
ES2525506B1 (es) * | 2013-05-21 | 2015-10-01 | Fundación Para La Investigación Hospital Clínico Universitario De Valencia | Prótesis maxilo-mandibular y método de fabricación |
CN103690274B (zh) * | 2013-12-31 | 2016-07-13 | 北京爱康宜诚医疗器材股份有限公司 | 骨缺失修复装置 |
ES2544904B1 (es) * | 2014-03-04 | 2016-07-07 | Francisco Javier RUIZ GINER | Injerto artificial odontológico |
CA2954529C (en) * | 2014-07-09 | 2023-03-07 | DePuy Synthes Products, Inc. | Flexible maxillo-mandibular fixation device |
TWI578976B (zh) * | 2015-12-09 | 2017-04-21 | 財團法人金屬工業研究發展中心 | 骨修復物 |
BE1026320B1 (nl) * | 2018-05-30 | 2020-01-13 | Tita Link B V B A | Kaakverplaatsingssysteem en werkwijze voor het vervaardigen van een dergelijk systeem voor de behandeling van slaapapneu en/of snurken. |
CN110200726B (zh) * | 2019-06-25 | 2024-09-13 | 上海交通大学医学院附属第九人民医院 | 下颌骨缺损修复体 |
CN111297518A (zh) * | 2020-02-14 | 2020-06-19 | 西安交通大学 | 一种基于3d打印热塑性材料/软组织共生骨植入物 |
CN112370098B (zh) * | 2020-10-20 | 2022-02-25 | 广东施泰宝医疗科技有限公司 | 关节置换术用肌腱缝合系统 |
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