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WO2018103640A1 - Système de réparation crânienne et son procédé de préparation - Google Patents

Système de réparation crânienne et son procédé de préparation Download PDF

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Publication number
WO2018103640A1
WO2018103640A1 PCT/CN2017/114640 CN2017114640W WO2018103640A1 WO 2018103640 A1 WO2018103640 A1 WO 2018103640A1 CN 2017114640 W CN2017114640 W CN 2017114640W WO 2018103640 A1 WO2018103640 A1 WO 2018103640A1
Authority
WO
WIPO (PCT)
Prior art keywords
skull
repair system
repair
repairing
extension
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/CN2017/114640
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English (en)
Chinese (zh)
Inventor
范小敏
罗百顺
刘曼
文平
袁玉宇
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medprin (shenzhen) Regenerative Medical Technologies Co Ltd
Medprin Regenerative Medical Technologies Co Ltd
Original Assignee
Medprin (shenzhen) Regenerative Medical Technologies Co Ltd
Medprin Regenerative Medical Technologies Co Ltd
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
Priority claimed from CN201621323384.1U external-priority patent/CN206700264U/zh
Priority claimed from CN201720093481.4U external-priority patent/CN207341838U/zh
Application filed by Medprin (shenzhen) Regenerative Medical Technologies Co Ltd, Medprin Regenerative Medical Technologies Co Ltd filed Critical Medprin (shenzhen) Regenerative Medical Technologies Co Ltd
Publication of WO2018103640A1 publication Critical patent/WO2018103640A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/28Bones

Definitions

  • the invention relates to a human implant component, in particular to a skull repair system and a preparation method thereof.
  • Cranioplasty is one of the most common operations in neurosurgery. Its main purpose is to prevent brain tissue from being damaged again, to restore cranial cavity tightness, and to treat skull defect syndrome.
  • the research on the skull repair prosthesis mainly focuses on the titanium metal material. Titanium is a metal element. After the skull repair prosthesis is made, the skull repair prosthesis of the titanium mesh is mostly a flat surface with high hardness. Metal plate.
  • a common method is to reserve about 1 cm at the edge of the titanium mesh to cover the edge of the bone window, but the titanium mesh is prone to curling after implantation. Problems such as exposed edges.
  • a PEEK skull repairing stencil which uses PEEK material instead of titanium metal to have better biocompatibility, and does not cause secondary damage to the injured skull, but needs to be additionally used during the operation.
  • the connecting piece connects the repairing net and the skull, which is inconvenient to use.
  • the object of the present invention is to overcome the problem that the prior art skull repair prosthesis needs to additionally connect the skull repair prosthesis and the autogenous skull to fix the skull repair prosthesis during use, and the use of the inconvenient problem is provided.
  • a cranial repair system that is easy to use and has good biocompatibility.
  • Another object of the present invention is to provide a method of preparing a skull repair system.
  • Another object of the present invention is to provide a method of using a skull repair system.
  • a skull repair system comprising a repair body formed of a polyaryletherketone material, the repair body being provided with a lap, the lap comprising an extension for connecting the repair body and the self skull, the lap
  • the sheet is integrally formed with the repairing body.
  • the structural relationship between the lap and the repairing body may be one of the following three ways.
  • the first way is that the extension is formed by directly extending the edge of the repairing body such that the upper surface of the extension is coplanar with the upper surface of the repairing body.
  • the slab accommodating cavity is first ground at the corresponding position of the autogenous skull, and the depth of the accommodating cavity is substantially the same as the thickness of the lap.
  • the extension of the tab is placed in the receiving chamber and then fixed using a fixing nail. Since the extension is formed by the edge extension of the repairing body, Therefore, after the skull repair system is fixed, the lap is embedded in the autologous skull, and the extension and the surrounding skull have a smooth transition and are more beautiful.
  • the second way is that the tab further comprises a connecting portion extending from an edge of the repairing body to form an upper surface slightly lower than the repairing body, the connecting portion being connected to the extending portion such that an upper surface of the extending portion Below the upper surface of the repaired body.
  • the upper surface of the extended portion is lower than the upper surface of the repairing body by 0.5 to 1.5 mm, and more preferably 1.0 mm.
  • the skull repair system in this manner is based on the position of the slab during the skull repair operation, and the bone corresponding to the lap on the autologous skull is honed, and the accommodating cavity formed by the ossicular bone has a depth greater than that of the extension.
  • the thickness is about 1 mm
  • the length and width of the receiving cavity are larger than the size of the extension portion by about 1 to 2 mm, so that the position of the repairing body can be adjusted, and then the skull repairing system is placed in a corresponding position, and after adjusting the position to a suitable position,
  • the prepared bone cement is filled into the accommodating cavity where the lap piece is placed to complete the fixation of the skull repair system.
  • the skull repair system of this structure combined with the fixation method of the bone cement, can enable the skull repair system to be implanted in the body, and can truly achieve zero artifacts, and does not affect image examination such as CT and magnetic resonance.
  • image examination such as CT and magnetic resonance.
  • a smooth transition between the upper surface of the cured bone cement and the upper surface of the repairing body and the upper surface of the autologous skull can be achieved.
  • the lap and bone cement After the lap and bone cement are fixed, it is enough to withstand the horizontal direction of the repairing body, and can meet the corresponding requirements in terms of mechanics.
  • the combination of the lap and the bone cement can be fixed without additional drilling and fixing nails, reducing the risk of surgery and the cost of surgery.
  • the third type is that the tab further includes an upwardly protruding connecting portion of the edge of the repairing body such that the connecting portion protrudes from the upper surface of the repairing body, and the extending portion is connected to the repairing body through the connecting portion, so that The upper surface of the extended portion is higher than the upper surface of the repairing body.
  • the lower surface of the lap can be directly attached to the autologous skull, and the fixation can be directly performed by using the fixing nail without grinding the bone, which can simplify the operation.
  • the lower surface of the extension is substantially coplanar with the upper surface of the repair body such that when the extension is in contact with the skull, the upper surface of the repair body is substantially coplanar with the upper surface of the native skull.
  • the structure design of the above-mentioned splicing piece and the repairing body can be selected by the doctor according to actual needs.
  • those skilled in the art can also adopt other connection methods, and only need to achieve the connection purpose of the present invention.
  • the repaired body conforms to the size, shape, and curvature of the defect skull bone window.
  • the polyaryletherketone material is polyetheretherketone (PEEK), polyetherketoneketone (PEKK), polyetherketone, polyetherketoneetherketoneketone (PEKEKK) or polyetheretherketoneketone (PEEKK). Any one or a mixture of at least two, preferably polyetheretherketone (PEEK).
  • the polyaryletherketone-based material used in the present invention is preferably an implant grade polyaryletherketone-based material.
  • the skull repairing system of the invention selects a polyaryletherketone material which is equivalent to the bone hardness, strength and weight of the human body, and has better biocompatibility compared with the titanium mesh, and avoids the stimulation of the skull tissue by the metal mesh plate. Allergic, rejection, and has good strength, toughness, and is not easily deformed by external forces.
  • the repairing body is three-dimensionally reconstructed according to the data collected by the patient CT to complete the personalized design, and then is obtained by 3D printing and/or machining (such as CNC), which completely matches the shape, size and curvature of the missing skull. .
  • a tab for attachment to the autologous skull.
  • the patch is used to connect the repairing body and the autologous skull, and it is no longer necessary to connect the repairing body and the autologous skull with another connecting member during the operation, which is more convenient to use and can prevent collapse after implantation.
  • the CT includes ordinary CT (Computed Tomography), and enhanced techniques of CT, such as CTA (CT angiography) and the like.
  • the extension portion is preferably provided with a mounting hole, so that no additional opening is required during the operation, and the skull repair system can be directly fixed by screws.
  • the extension has a thickness of 1.0 to 1.5 mm.
  • the extension has a length of 8 to 10 mm, and the extension has a width of 4 to 9 mm.
  • the edge of the extension is a rounded edge.
  • the smooth edges are designed to avoid possible damage to the skull or other tissues caused by sharp parts.
  • the tabs may be evenly or unevenly distributed around the repair body.
  • the lap can be designed according to the actual needs, and can avoid the weak bones.
  • the number of the tabs is 3-6.
  • the number of laps is not limited, and can be set according to actual needs, and can be sufficiently stable to fix the skull repair system.
  • the repair body has a thickness of 1 to 8 mm; and/or the thickness of the repair body is uneven.
  • the repair body is provided with a through hole.
  • the setting of the through hole can facilitate the discharge of the cerebral spinal fluid and effectively reduce the subcutaneous fluid.
  • the through holes are distributed in a matrix.
  • the through hole has a hole diameter of 2 to 3 mm, and a distance between adjacent through holes is 10 to 15 mm.
  • a method for preparing a skull repair system includes the following steps:
  • Skull scan data can be obtained from the hospital's imaging department to obtain CT or CTA scan data of the patient, and the data is saved in DICOM format.
  • the original DICOM imaging format data is a two-dimensional black-and-white image.
  • three-dimensional reconstruction software such as mimics, 3Ddoctor, etc.
  • the grayscale is extracted according to the bone and reconstructed to obtain a visual three-dimensional model of the missing skull.
  • the skull design of the defect site is designed to obtain a three-dimensional skull restoration by introducing the defective skull model into design software, such as Solidworks, Freeform, 3-Matic, and the like.
  • the edge of the skull prosthesis is designed to be lapped, and the position of the lap, that is, the position of the lap and the skull restoration should be avoided.
  • the specific design method of the lap is to draw a two-dimensional image of the slab on the plane, projecting to the surface where the splicing position is selected, such as the original skull surface, and the shape of the slab is on the original defect skull and the prosthesis. Displayed as a reference surface, using the increased thickness operation to obtain a slab of a certain thickness that fits perfectly with the edge of the original skull bone window.
  • the scanning layer thickness in S1 is 0.625 to 2 mm.
  • the scanning layer thickness in S1 is 0.625-1.25 mm.
  • the design in S2 includes the design of the curvature, thickness, and edge contour of the skull restoration.
  • the design in S2 also includes curvature adjustment, and/or sanding, and/or smoothing.
  • the three-dimensional skull repair body described in S3 is introduced into an optimization software for optimization processing.
  • a method for using a skull repair system which is placed in a skull defect site, adjusted to an appropriate position, and fixed.
  • a method of using a skull repair system includes the following steps:
  • Grinding bone grinding the autologous skull of the repaired part, the bone depth is 1.5 ⁇ 2.5mm, and the length and width are larger than the extension 1 ⁇ 2mm;
  • the repairing system is placed in the skull defect site, adjusted to an appropriate position, and bone cement is implanted above the extension portion to complete the fixation of the repair system.
  • the self-body skull of the corresponding part is ground, the depth after grinding is about 2 mm, and the length and width are about 1 to 2 mm larger than the size of the lap. More effective fixation is achieved by adjusting the position of the skull repair system and solidifying the bone cement.
  • the present invention has the following beneficial technical effects:
  • the skull repairing system According to the skull repairing system provided by the present invention, according to the patient's skull defect, a repairing body which is consistent with the shape, size and curvature of the missing skull is prepared, and the repairing body and the bone window are completely matched.
  • the splicing facilitates the fixation of the skull repair system during surgery, eliminating the need for additional connecting components to connect the prosthetic body to the autologous skull.
  • the skull repairing system is formed by using polyaryletherketone material, which has good biocompatibility and avoids the phenomenon of rejection.
  • the preparation process is simple and efficient.
  • the three-dimensional design and optimized treatment of the skull repair system and the defect site are precisely matched, and the use is convenient and quick.
  • the special design of the lap joint helps to form a smooth repair surface after surgery, so that the effect after repair is more beautiful. .
  • Figure 1 is a schematic view showing the structure of the skull repairing system
  • FIGS. 2 and 3 are schematic views showing the first connection mode when the skull repair system is connected to the skull;
  • FIG. 4 is a schematic view showing a second connection manner when the skull repair system is connected to a skull
  • Figure 5 is a schematic view showing the third connection mode when the skull repair system is connected to the skull.
  • FIG. 2 and FIG. 3 show a first embodiment of the present invention, a skull repair system, which is reconstructed according to the data collected by the patient's CT or CTA, and is designed to match the shape, size, and curvature of the skull.
  • the repairing body 1, and the tab 2 integrally formed with the repairing main body 1, and then obtaining the solid skull repairing system by a 3D printing technique using a preparation material containing a polyaryletherketone-based material.
  • the thickness of the repair body 1 is 1 to 8 mm.
  • the tab has an extension portion 21 for connecting the repairing body and the autologous skull, the extension portion 21 being formed by extending an edge of the repairing body such that an upper surface of the extending portion 21 and the upper surface of the repairing body The surface is coplanar.
  • a mounting hole 5 is provided in the extended portion 21 of the tab.
  • the extending portion has a rectangular shape as a whole, and the end portion has two rounded chamfers, the length is 8 to 10 mm, the width is 4 to 9 mm, and the thickness is 1.2 to 1.5 mm.
  • the tab 2 is distributed around the repairing body 1. .
  • a through hole 3 is provided in the repair main body 1. The through hole has a hole diameter of 2 to 3 mm and a through hole pitch of 10 to 15 mm.
  • the same shape of the gap is made on the autologous skull at the edge of the defect skull window.
  • the extension portion 21 is formed by directly extending from the edge of the repairing body, the extension portion does not protrude when the repairing body is connected to the skull in the manner shown in FIG.
  • the transition between the lap and the surrounding autologous skull is smooth and more beautiful.
  • FIG. 4 As another solution for realizing the skull repair system of the present invention, it is also possible to design as shown in FIG. 4:
  • a skull repair system comprising a repair body 1 formed of a polyetheretherketone material, the repair body 1 being provided with a flap 2, the tab comprising an extension 21 for connecting the repair body and the autologous skull
  • the patch is integrally formed with the repairing body;
  • the tab further includes a connecting portion 22 extending from an edge of the repairing body to be slightly lower than an upper surface of the repairing body, the connecting portion being connected to the extending portion 21 such that an upper surface of the extending portion 21 is lower than Repair the upper surface of the body 1.
  • the thickness of the repaired body was 8 mm
  • the thickness of the extended portion was 1 mm
  • the upper surface of the extended portion 21 was 1 mm away from the surface of the prosthesis main body.
  • the extending portion has a rectangular shape as a whole, and the end portion has two rounded chamfers, the length is 8 to 10 mm, and the width is 4 to 9 mm.
  • the tab 2 is distributed around the repairing body 1.
  • a through hole 3 is provided in the repair main body 1.
  • the through hole has a hole diameter of 2 to 3 mm, adjacent The distance between the through holes is 10 to 15 mm.
  • the splicing accommodating cavity is firstly grounded at the corresponding position of the autogenous skull, and the depth of the accommodating cavity is 2 mm, so that when the lap is placed in the accommodating cavity, the upper surface of the main body and the autologous skull are repaired.
  • the upper surface is coplanar; the size of the receiving cavity is slightly larger than the size of the tab, so that the position of the repairing body can be adjusted for fixing, and then the bone cement is filled in the receiving cavity, so that the upper surface of the cured bone cement and the upper surface of the repairing body, A smooth transition between the upper surfaces of the autologous skull.
  • the lap and bone cement After the lap and bone cement are fixed, they can withstand the horizontal force of the repairing body, and can meet the corresponding requirements in terms of mechanics.
  • the combination of the lap and the bone cement can be fixed without additional drilling, eliminating the need for fixing nails.
  • a skull repairing system comprising a repairing body 1 formed of a polyetheretherketone-like material, the repairing body 1 being provided with a lap, the slat comprising an extension 21 for connecting the repairing body and the self-skull,
  • the tab is integrally formed with the repairing body; the tab further includes an upwardly protruding connecting portion 22 by the edge of the repairing body such that the connecting portion protrudes relative to the upper surface of the repairing body, the extending portion 21 is connected to the repairing body 1 through the connecting portion 22 such that the upper surface of the extending portion is higher than the upper surface of the repairing body.
  • the bone is not required to be ground, and the repaired body is adjusted to the corresponding position of the bone window, and the patch is directly placed on the surface of the autologous skull 4 to be fixed, which can simplify the operation.
  • the preparation of the skull repair system of Examples 1-3 includes the following steps:
  • S2 Recognition by mimics of 3D reconstruction software, grayscale extraction and reconstruction of bone to obtain a visual 3D model of the defect skull, and introducing the defective skull model into the design software Solidworks to design the curvature, thickness and edge contour of the skull restoration.
  • the three-dimensional skull prosthesis is further optimized by Wrap optimization software to optimize the curvature and edge contour of the skull prosthesis and smooth adjustment;
  • S3 Design the slab on the skull patch visualization model, draw a two-dimensional map of the slab on the plane, project to the surface where the splicing position is selected (such as the original skull surface), and the shape of the slab is in the original defect skull.
  • the patch is displayed on the prosthesis, which is displayed as a reference surface, and the thickness is increased to obtain a patch having a certain thickness and completely conforming to the edge of the original skull bone window;
  • S5 3D printing or machining to produce a three-dimensional structure of the skull repair system.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne un système de réparation crânienne et un procédé de préparation de celui-ci. Le système de réparation crânienne comprend un corps principal de réparation (1) formé d'un matériau à base de polyaryléthercétone. Des pattes (3) sont disposées sur le corps principal de réparation (1) et comprennent des parties étendues (21) pour relier le corps principal de réparation (1) et un crâne autogène (4). Les pattes (3) et le corps principal de réparation (1) sont formés de façon intégrée. La forme, la taille et le radian du système de réparation crânienne correspondent à ceux d'un crâne défectueux. Les pattes (3) facilitent la fixation du système de réparation crânienne pendant une chirurgie, en éliminant le besoin d'une partie de liaison supplémentaire pour relier le corps principal de réparation (1) au crâne autologue (4), et peut éviter un affaissement après la réparation. Le système de réparation crânienne est formé d'un matériau à base de polyaryléthercétone, et présente ainsi une bonne biocompatibilité, de façon à éviter le rejet. Le procédé de préparation est simple et efficace. Le système de réparation crânienne obtenu après une conception tridimensionnelle et un traitement optimisé correspond exactement au site défectueux, ce qui facilite son utilisation. La conception spéciale de la partie de connexion de patte (22) facilite la formation d'une surface lisse réparée après une chirurgie, ce qui rend la surface de réparation visuellement esthétique.
PCT/CN2017/114640 2016-12-05 2017-12-05 Système de réparation crânienne et son procédé de préparation Ceased WO2018103640A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN201621323384.1 2016-12-05
CN201621323384.1U CN206700264U (zh) 2016-12-05 2016-12-05 一种颅骨修补系统
CN201720093481.4U CN207341838U (zh) 2017-01-24 2017-01-24 颅骨修补系统
CN201720093481.4 2017-01-24

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WO2018103640A1 true WO2018103640A1 (fr) 2018-06-14

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Cited By (8)

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CN110176066A (zh) * 2019-05-28 2019-08-27 中山大学附属第三医院 颅骨缺损结构的重建方法、装置及电子设备
CN111053630A (zh) * 2019-12-10 2020-04-24 佛山市逸合生物科技有限公司 一种头颅修复钛网
CN112712588A (zh) * 2020-12-29 2021-04-27 西安康拓医疗技术股份有限公司 一种peek骨板数据重建方法
CN113711993A (zh) * 2021-09-01 2021-11-30 杭州越波生物科技有限公司 一种利用Micro-CT定量评价大鼠颅骨骨缺损后的骨再生修复能力的方法
CN114099086A (zh) * 2021-12-16 2022-03-01 北京力达康科技有限公司 一种股骨骨缺损髋关节治疗假体
CN115063556A (zh) * 2022-08-17 2022-09-16 中国汽车技术研究中心有限公司 一种汽车碰撞假人颅骨模型的构建方法
CN120478004A (zh) * 2025-07-16 2025-08-15 湖南金柏威医疗科技有限公司 基于peek颅骨修补材料的颅骨缺损修复结构
CN120549658A (zh) * 2025-07-30 2025-08-29 首都医科大学宣武医院 一种颅骨修复组件

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CN101953726A (zh) * 2010-09-20 2011-01-26 李长安 一种个性化颅骨修复体及其制备方法
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Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110176066A (zh) * 2019-05-28 2019-08-27 中山大学附属第三医院 颅骨缺损结构的重建方法、装置及电子设备
CN110176066B (zh) * 2019-05-28 2023-04-18 中山大学附属第三医院 颅骨缺损结构的重建方法、装置及电子设备
CN111053630A (zh) * 2019-12-10 2020-04-24 佛山市逸合生物科技有限公司 一种头颅修复钛网
CN112712588A (zh) * 2020-12-29 2021-04-27 西安康拓医疗技术股份有限公司 一种peek骨板数据重建方法
CN112712588B (zh) * 2020-12-29 2023-11-07 西安康拓医疗技术股份有限公司 一种peek骨板数据重建方法
CN113711993A (zh) * 2021-09-01 2021-11-30 杭州越波生物科技有限公司 一种利用Micro-CT定量评价大鼠颅骨骨缺损后的骨再生修复能力的方法
CN114099086A (zh) * 2021-12-16 2022-03-01 北京力达康科技有限公司 一种股骨骨缺损髋关节治疗假体
CN115063556A (zh) * 2022-08-17 2022-09-16 中国汽车技术研究中心有限公司 一种汽车碰撞假人颅骨模型的构建方法
US11735065B1 (en) 2022-08-17 2023-08-22 China Automotive Technology And Research Center Co., Ltd Method for building vehicle crash dummy skull model
CN120478004A (zh) * 2025-07-16 2025-08-15 湖南金柏威医疗科技有限公司 基于peek颅骨修补材料的颅骨缺损修复结构
CN120549658A (zh) * 2025-07-30 2025-08-29 首都医科大学宣武医院 一种颅骨修复组件

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