CN105748179A - Personalized airway stent manufacturing technology - Google Patents
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- 238000005516 engineering process Methods 0.000 title claims abstract description 9
- 238000004519 manufacturing process Methods 0.000 title description 2
- 208000031481 Pathologic Constriction Diseases 0.000 claims abstract description 12
- 230000036262 stenosis Effects 0.000 claims abstract description 12
- 208000037804 stenosis Diseases 0.000 claims abstract description 12
- 229920001296 polysiloxane Polymers 0.000 claims abstract description 4
- 239000012620 biological material Substances 0.000 claims abstract 2
- 238000002591 computed tomography Methods 0.000 claims description 4
- 230000003213 activating effect Effects 0.000 claims 1
- 230000008676 import Effects 0.000 claims 1
- 206010063560 Excessive granulation tissue Diseases 0.000 abstract description 3
- 210000001126 granulation tissue Anatomy 0.000 abstract description 3
- 206010020718 hyperplasia Diseases 0.000 abstract description 3
- 230000007547 defect Effects 0.000 abstract description 2
- 206010016717 Fistula Diseases 0.000 description 3
- 230000003890 fistula Effects 0.000 description 3
- 238000002513 implantation Methods 0.000 description 3
- 239000000463 material Substances 0.000 description 2
- 238000010146 3D printing Methods 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 208000000059 Dyspnea Diseases 0.000 description 1
- 206010013975 Dyspnoeas Diseases 0.000 description 1
- 206010065713 Gastric Fistula Diseases 0.000 description 1
- HZEWFHLRYVTOIW-UHFFFAOYSA-N [Ti].[Ni] Chemical compound [Ti].[Ni] HZEWFHLRYVTOIW-UHFFFAOYSA-N 0.000 description 1
- 238000009395 breeding Methods 0.000 description 1
- 230000001488 breeding effect Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000006073 displacement reaction Methods 0.000 description 1
- 210000004229 gastric stump Anatomy 0.000 description 1
- 238000005469 granulation Methods 0.000 description 1
- 230000003179 granulation Effects 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 230000003211 malignant effect Effects 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 229910001000 nickel titanium Inorganic materials 0.000 description 1
- 208000023504 respiratory system disease Diseases 0.000 description 1
- 208000037803 restenosis Diseases 0.000 description 1
- 230000028327 secretion Effects 0.000 description 1
- 229910001285 shape-memory alloy Inorganic materials 0.000 description 1
- 210000003437 trachea Anatomy 0.000 description 1
- 238000002627 tracheal intubation Methods 0.000 description 1
- 230000008733 trauma Effects 0.000 description 1
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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B33—ADDITIVE MANUFACTURING TECHNOLOGY
- B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- B33Y10/00—Processes of additive manufacturing
-
- 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
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Transplantation (AREA)
- Vascular Medicine (AREA)
- Manufacturing & Machinery (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Chemical & Material Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Materials Engineering (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
本发明公开了一种个性化气道支架的制备技术。本发明所述的个性化气道支架是利用CT影像重建患者气道的狭窄模型,并在三维数值模型重建软件中对气道模型狭窄处进行扩张20%~40%,再将处理过的气道模型最外侧的壁面向外扩张10%形成支架的外壁。利用以上处理设计出个性化气道支架的三维数值模型。最后将个性化气道支架模型导入3D打印机中,并注入硅酮等医用生物材料,制备出符合患者气道结构的个性化支架。本发明根据不同的患者气道狭窄处进行三维建模并设计出个性化气道支架,克服了现有商业气道支架难以贴合患者的气道,容易引发肉芽组织增生的不足和缺陷。
The invention discloses a preparation technology of a personalized airway bracket. The personalized airway stent of the present invention uses CT images to reconstruct the stenosis model of the patient's airway, and expands the stenosis of the airway model by 20% to 40% in the three-dimensional numerical model reconstruction software, and then the processed airway The outermost wall of the tract model was expanded outward by 10% to form the outer wall of the stent. A three-dimensional numerical model of a personalized airway stent was designed using the above processing. Finally, the personalized airway stent model is imported into the 3D printer, and medical biomaterials such as silicone are injected to prepare a personalized stent that conforms to the patient's airway structure. The present invention carries out three-dimensional modeling and designs a personalized airway stent according to different patients' airway stenosis, which overcomes the shortcomings and defects that the existing commercial airway stents are difficult to fit the patient's airway and easily cause granulation tissue hyperplasia.
Description
技术领域technical field
本发明属于人体气道植介入医疗器械领域,特别涉及一种个性化气道支架的制备技术。The invention belongs to the field of human airway implant interventional medical devices, and in particular relates to a preparation technology of a personalized airway stent.
背景技术Background technique
近年来各种良、恶性疾病以及外伤、气管切开或插管等引发的气道疾病日益增多,如气道狭窄、气管壁塌陷、气道-食道或残胃瘘、气道-胸腔瘘等,气道狭窄和气管壁塌陷在临床上通常采用支架植入术,这样可以迅速地扩张气道,缓解呼吸困难,气道-食道或残胃瘘、气道-胸腔瘘等也可采用覆膜支架植入术来进行封堵。自十九世纪九十年代Trendelenburg和Bond放置了T型管用于治疗气道狭窄以来,人们一直致力于气道支架的研究,采用多种材料,设计出了各种各样的气道支架。目前常用的气管、支气管支架的种类主要有两大类:(一)硅酮管状支架,其中包括:Dumon支架、T型管支架、Dynamic支架等;(二)金属网眼支架:其中包括:Palmaz支架、Stecker支架、Ultrflex支架、国产镍钛记忆合金支架、Wall支架、Gianturco支架等,而这一系列支架由于不能完全地顺应气道结构,均或多或少地存在如下问题:(1)不能完全贴附气管壁。人体气管的横截面并非完全呈圆形,且上下并非一般粗细,而目前临床应用的气道支架横截面多为圆形,且上下一般粗细,因而在支架和气管壁之间会存在一些空隙,气道分泌物易在此处储留,进而成为细菌等滋生的场所,同时气道支架容易发生移位;(2)气管壁受力不均。生物力学活的灵魂“应力-生长”关系表明:各个层次生命体的结构、功能以及生长都与它们所处的力学环境(应力场)密切相关,人体气道支架也不例外。临床数据显示,植入支架后期,气管壁受力较大的区域易长肉芽,例如支架的两端,从而使管腔发生再狭窄,如不及时处理,严重的可危及患者的生命。In recent years, various benign and malignant diseases and airway diseases caused by trauma, tracheotomy or intubation have been increasing, such as airway stenosis, tracheal wall collapse, airway-esophageal or gastric remnant fistula, airway-thoracic fistula, etc. , airway stenosis and tracheal wall collapse are usually treated clinically with stent implantation, which can rapidly expand the airway and relieve dyspnea. Airway-esophagus or remnant gastric fistula, airway-thoracic fistula, etc. Stent implantation for closure. Since Trendelenburg and Bond placed T-shaped tubes for the treatment of airway stenosis in the 1890s, people have been working on the research of airway stents, and various materials have been used to design various airway stents. There are two main types of commonly used tracheal and bronchial stents: (1) Silicone tubular stents, including: Dumon stents, T-tube stents, Dynamic stents, etc.; (2) Metal mesh stents: including: Palmaz stents , Stecker stent, Ultrflex stent, domestic nickel-titanium memory alloy stent, Wall stent, Gianturco stent, etc., and these series of stents have more or less the following problems because they cannot completely conform to the airway structure: (1) they cannot completely conform to the airway structure. Attached to the tracheal wall. The cross-section of the human trachea is not completely circular, and the upper and lower sides are not generally thick, but the cross-section of the airway stents currently used in clinical practice is mostly circular, and the upper and lower thickness are generally thin, so there will be some gaps between the stent and the tracheal wall. Airway secretions are easy to store here, and then become a breeding place for bacteria, etc. At the same time, the airway stent is prone to displacement; (2) The force on the tracheal wall is uneven. The "stress-growth" relationship of the living soul in biomechanics shows that the structure, function and growth of living organisms at all levels are closely related to their mechanical environment (stress field), and the human airway stent is no exception. Clinical data show that in the later stage of stent implantation, granulation tends to grow in areas with greater stress on the tracheal wall, such as the two ends of the stent, resulting in restenosis of the lumen. If it is not treated in time, it may seriously endanger the life of the patient.
因此,探寻个性化的气道支架成为当务之急,研究的结果将具有重要的临床价值及社会意义。Therefore, it is imperative to explore personalized airway stents, and the results of the research will have important clinical value and social significance.
发明内容Contents of the invention
为了克服现有商业气道支架难以贴合患者的气道,容易引发肉芽组织增生的不足和缺陷。本发明的首要目的在于制备出一种个性化的气道支架。In order to overcome the shortcomings and defects that the existing commercial airway stents are difficult to fit the patient's airway and easily cause granulation tissue hyperplasia. The primary purpose of the present invention is to prepare a personalized airway stent.
本发明首先基于医学影像三维数值模型重建软件设计出个性化的气道支架,然后再利用3D打印机制备个性体化的气道支架。The present invention firstly designs a personalized airway support based on the three-dimensional numerical model reconstruction software of medical images, and then uses a 3D printer to prepare a personalized airway support.
本发明上述目的通过以下技术方案来实现:The above object of the present invention is achieved through the following technical solutions:
1)获取患者气道狭窄部分的CT扫描数据;1) Obtain CT scan data of the narrow part of the patient's airway;
2)重建患者气道狭窄部分的三维数值模型;2) Reconstruct the three-dimensional numerical model of the narrow part of the patient's airway;
3)设计个性化气道支架的三维数值模型;3) Design a three-dimensional numerical model of a personalized airway stent;
4)将此模型输入至3D打印机中制备出个性化的气道支架。4) Input this model into the 3D printer to prepare a personalized airway stent.
相对于现有的商业支架,本发明具有如下的优点:Compared with existing commercial supports, the present invention has the following advantages:
1)现有的气道支架属于批量化生产,由于每个人的气道都是具有特殊性。因此现有的商业支架并不适用于每个不同的患者。本发明所制备的个性化气道支架符合患者个体的气道结构与形态,可以完全贴合患者的气道,进而可以减少气道肉芽组织的过度增生增生;1) Existing airway stents belong to mass production, because everyone's airway is unique. Therefore existing commercial stents are not suitable for every different patient. The personalized airway stent prepared by the present invention conforms to the airway structure and shape of the individual patient, can completely fit the patient's airway, and can further reduce the excessive hyperplasia of airway granulation tissue;
2)本发明根据不同的患者不同气道狭窄处进行三维建模并适当的进行处理,因此做到了个性化气道支架的设计;2) The present invention performs three-dimensional modeling according to different patients with different airway stenosis and properly handles it, so that the design of individualized airway stents is achieved;
3)本发明仅需要得到患者的CT扫描数据即可设计出完整的符合患者气道结构的个性化气道支架模型。3) The present invention only needs to obtain the CT scan data of the patient to design a complete personalized airway stent model conforming to the patient's airway structure.
附图说明Description of drawings
图1为本发明重建气道狭窄段的三维数值模型。Fig. 1 is a three-dimensional numerical model of the reconstructed airway stenosis segment according to the present invention.
图2为本发明根据气道狭窄所设计的个性化气道支架三维数值模型。Fig. 2 is a three-dimensional numerical model of a personalized airway stent designed according to the airway stenosis of the present invention.
图3为本发明根据患者气道狭窄情况所设计的个性化气道支架的截面图。Fig. 3 is a cross-sectional view of the personalized airway stent designed according to the airway stenosis of the patient according to the present invention.
具体实施方式detailed description
下面结合实施方式对本发明做进一步详细的描述,但本发明的实施方式不限于此。The present invention will be described in further detail below in conjunction with the embodiments, but the embodiments of the present invention are not limited thereto.
步骤一:获取患者气道狭窄部分的CT扫描数据,重建患者气道狭窄部分的三维数值模型;Step 1: Obtain CT scan data of the narrow part of the patient's airway, and reconstruct a three-dimensional numerical model of the narrow part of the patient's airway;
步骤二:对气道模型进行光滑和修剪处理,在三维数值模型重建软件中将狭窄处的直径扩张20%~40%;Step 2: Smooth and trim the airway model, and expand the diameter of the stenosis by 20% to 40% in the three-dimensional numerical model reconstruction software;
步骤三:在此基础上将气道最外侧的壁面向外延展10%,作为气道支架数值模型的外壁面,模型闭合后自动生成个性化气道支架的三维数值模型;Step 3: On this basis, extend the outermost wall of the airway by 10% as the outer wall of the numerical model of the airway stent, and automatically generate a three-dimensional numerical model of the personalized airway stent after the model is closed;
步骤四:将上一步所设计出的模型输入3D打印机中,添加硅酮等生物医用材料进行3D打印,从而制备出一种个性化的气道支架。Step 4: Input the model designed in the previous step into the 3D printer, and add biomedical materials such as silicone for 3D printing, thereby preparing a personalized airway stent.
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| CN106344231A (en) * | 2016-10-27 | 2017-01-25 | 中国人民解放军第四军医大学 | 3D (three-dimensional) printing degradable trachea outer stent for treating tracheostenosis and manufacturing method thereof |
| CN107174385A (en) * | 2017-07-04 | 2017-09-19 | 无锡市第二人民医院 | A kind of trachea-bronchial epithelial cell support and preparation method thereof |
| US12180320B2 (en) | 2018-09-20 | 2024-12-31 | Shin-Etsu Chemical Co., Ltd. | Ultraviolet curable silicone composition and cured product thereof |
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| CN114556484A (en) * | 2019-07-11 | 2022-05-27 | 克利夫兰临床基金会 | System and method for model-based stent design and placement |
| WO2021007570A1 (en) * | 2019-07-11 | 2021-01-14 | The Cleveland Clinic Foundation | System and method for model-based stent design and placement |
| US12462379B2 (en) | 2019-07-11 | 2025-11-04 | The Cleveland Clinic Foundation | System and method for model-based stent design and placement |
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| CN118448050A (en) * | 2024-07-08 | 2024-08-06 | 山东大学 | CT-based large airway stenosis patient lung function prediction method, device, equipment and storage medium |
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