CN114601558A - A laser ablation catheter with variable fiber helix angle - Google Patents
A laser ablation catheter with variable fiber helix angle Download PDFInfo
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Abstract
本发明公开了一种变光纤螺旋角度的激光消融导管,属于医疗器械相关技术领域,该激光消融导管包括外包层、内衬层和光导纤维;所述外包层与所述内衬层同轴平行设置,所述外包层与所述内衬层之间设有多层光导纤维;所述光导纤维自所述激光消融导管的激光输入端至所述激光消融导管的激光输出端由平行于所述内衬层分布变换为绕所述内衬层螺旋分布。本发明通过对光导纤维的结构设计,达到使激光消融导管在血管中不同位置有更好力学性能的目的,提高激光消融导管的柔韧性,并保证导管的可操作性,降低对病人的身体损伤,适用于准分子激光冠脉斑块消融手术等医学场景。
The invention discloses a laser ablation catheter with a variable fiber helix angle, belonging to the technical field of medical devices. The laser ablation catheter comprises an outer layer, an inner liner and an optical fiber; the outer layer is coaxial and parallel to the inner liner A multi-layer optical fiber is arranged between the outer layer and the inner lining layer; the optical fiber runs from the laser input end of the laser ablation catheter to the laser output end of the laser ablation catheter parallel to the The inner liner distribution is transformed into a helical distribution around the inner liner. Through the structural design of the optical fiber, the invention achieves the purpose of making the laser ablation catheter have better mechanical properties at different positions in the blood vessel, improves the flexibility of the laser ablation catheter, ensures the operability of the catheter, and reduces the physical damage to the patient. , suitable for medical scenarios such as excimer laser coronary plaque ablation surgery.
Description
技术领域technical field
本发明属于医疗器械相关技术领域,更具体地,涉及一种变光纤螺旋角度的激光消融导管。The invention belongs to the technical field of medical equipment, and more particularly, relates to a laser ablation catheter with a variable optical fiber helix angle.
背景技术Background technique
ELCA手术主要通过激光导管将紫外光脉冲传输到硬化部位,作用机理为激光与组织之间的光化学、光热和光机械作用,激光与组织之间直接作用或者产生的水蒸气迅速膨胀和溃灭可以将硬化斑块消融,达到消除硬化斑块的目的。激光导管是为了将激光传送到动脉内的病变部位而设计的含有光学纤维的导管,必须使用非常纯的熔融二氧化硅(合成石英)来制造这些纤维,普通的玻璃纤维无法再手术必要的功率水平上传导紫外光。ELCA surgery mainly transmits ultraviolet light pulses to the sclerotic site through a laser catheter. The mechanism of action is photochemical, photothermal and opto-mechanical effects between the laser and the tissue. The direct interaction between the laser and the tissue or the rapid expansion and collapse of the generated water vapor can cause The sclerotic plaque is ablated to achieve the purpose of eliminating the sclerotic plaque. Laser catheters are catheters that contain optical fibers designed to deliver laser light to lesions within the arteries. Very pure fused silica (synthetic quartz) must be used to make these fibers, and ordinary glass fibers can no longer operate with the necessary power Conducts UV light horizontally.
目前手术所使用普通石英光纤导管在弯曲的血管中行进的效果不佳,会对病人的血管造成一定损伤,产生术后并发症,并且不便于医生操作。The ordinary quartz fiber optic catheter currently used in the operation is not effective in traveling in the curved blood vessel, which will cause certain damage to the patient's blood vessel, cause postoperative complications, and is inconvenient for doctors to operate.
因此,市场亟需Therefore, the market needs
发明内容SUMMARY OF THE INVENTION
针对现有技术的以上缺陷或改进需求,本发明提供了一种变光纤螺旋角度的激光消融导管,其目的在于改变光导纤维在光消融导管的激光输入端至激光消融导管的激光输出端的排布结构,由此解决现有激光消融导管在弯曲的血管中行进的效果不佳的技术问题。In view of the above defects or improvement requirements of the prior art, the present invention provides a laser ablation catheter with a variable fiber helix angle, the purpose of which is to change the arrangement of the optical fibers from the laser input end of the optical ablation catheter to the laser output end of the laser ablation catheter structure, thereby solving the technical problem that the existing laser ablation catheter has poor traveling effect in a curved blood vessel.
为实现上述目的,按照本发明的一个方面,提供了一种变光纤螺旋角度的激光消融导管,所述激光消融导管包括外包层、内衬层和光导纤维;In order to achieve the above object, according to one aspect of the present invention, a laser ablation catheter with a variable fiber helix angle is provided, the laser ablation catheter includes an outer layer, an inner liner and an optical fiber;
所述外包层与所述内衬层同轴平行设置,所述外包层与所述内衬层之间设有多层光导纤维;The outer cladding and the inner lining layer are coaxially arranged in parallel, and a multi-layer optical fiber is arranged between the outer cladding and the inner lining layer;
所述光导纤维自所述激光消融导管的激光输入端至所述激光消融导管的激光输出端由平行于所述内衬层分布变换为绕所述内衬层螺旋分布。The optical fiber is transformed from a laser input end of the laser ablation catheter to a laser output end of the laser ablation catheter from being distributed parallel to the inner lining layer to a helical distribution around the inner lining layer.
优选地,所述光导纤维设有两层,两层光导纤维同轴排布。Preferably, the optical fiber is provided with two layers, and the two layers of optical fibers are coaxially arranged.
优选地,所述外包层与所述内衬层之间还设有环氧树脂粘接层,所述环氧树脂粘接层用于填充所述光导纤维之间的空隙并使其粘接,从而使所述外包层、内衬层和光导纤维形成整体结构。Preferably, an epoxy resin adhesive layer is also provided between the outer layer and the inner lining layer, and the epoxy resin adhesive layer is used to fill the gaps between the optical fibers and make them bond, Thereby, the outer layer, the inner liner and the optical fiber form an integral structure.
优选地,所述外包层为聚四氟乙烯材料制成,其外表面涂覆润滑材料。Preferably, the outer layer is made of polytetrafluoroethylene material, and the outer surface thereof is coated with lubricating material.
优选地,内衬层为聚四氟乙烯材料制成,其内表面涂覆润滑材料。Preferably, the inner lining layer is made of polytetrafluoroethylene material, and the inner surface of which is coated with lubricating material.
优选地,所述激光消融导管还设有定位环,所述定位环设置于所述激光消融导管的激光输出端端面处,用于显示所述激光消融导管在血管中的位置。Preferably, the laser ablation catheter is further provided with a positioning ring, and the positioning ring is arranged at the end face of the laser output end of the laser ablation catheter, and is used to display the position of the laser ablation catheter in the blood vessel.
优选地,所述定位环为不透X光材料制成,其外层设有疏水涂层。Preferably, the positioning ring is made of X-ray opaque material, and its outer layer is provided with a hydrophobic coating.
优选地,还包括金属导丝,所述金属导丝贯穿于所述内衬层设置,用于牵引所述激光消融导管移动。Preferably, a metal guide wire is also included, and the metal guide wire is arranged through the inner lining layer and is used for pulling the laser ablation catheter to move.
优选地,所述金属导丝为无生物毒性和生物活性的金属材料制成。Preferably, the metal guide wire is made of a non-biotoxic and bioactive metal material.
优选地,所述金属导丝的直径为0.008inch~0.016inch。Preferably, the diameter of the metal guide wire ranges from 0.008 inch to 0.016 inch.
总体而言,通过本发明所构思的以上技术方案与现有技术相比,能够取得下列有益效果:In general, compared with the prior art, the above technical solutions conceived by the present invention can achieve the following beneficial effects:
1、本发明提出的变光纤螺旋角度的激光消融导管,通过将光导纤维自激光消融导管的激光输入端至激光消融导管的激光输出端由平行于内衬层分布变换为绕内衬层螺旋分布,可使激光消融导管远端具有良好的柔韧性,在进入血管后易于弯曲,可以更加顺畅的到达病灶部位,减小了手术过程中对病人的伤害;激光消融导管近端具有较好的可操作性,不易弯曲,可以使导管更好的沿着躯干主动脉推送,便于医生操控。1. The laser ablation catheter with variable fiber helix angle proposed by the present invention transforms the optical fiber from the laser input end of the laser ablation catheter to the laser output end of the laser ablation catheter from a distribution parallel to the inner lining layer to a helical distribution around the inner lining layer. It can make the distal end of the laser ablation catheter have good flexibility, and it is easy to bend after entering the blood vessel, which can reach the lesion more smoothly, reducing the damage to the patient during the operation; the proximal end of the laser ablation catheter has better flexibility It is maneuverable and not easy to bend, so that the catheter can be better pushed along the trunk aorta, which is convenient for doctors to control.
2、本发明提出的变光纤螺旋角度的激光消融导管,通过对光导纤维排布方式的设计,使其便于操作,与原有装置的兼容性良好,便于改进现有装置,提高血管消融手术的手术效果,降低术后风险。2. The laser ablation catheter with variable fiber helix angle proposed by the present invention is easy to operate through the design of the optical fiber arrangement, and has good compatibility with the original device, which is convenient to improve the existing device and improve the operation efficiency of blood vessel ablation. Surgical effect and reduce postoperative risk.
附图说明Description of drawings
图1是本发明变光纤螺旋角度的激光消融导管的结构示意图。FIG. 1 is a schematic structural diagram of a laser ablation catheter with a variable fiber helix angle of the present invention.
在所有附图中,相同的附图标记用来表示相同的元件或结构,其中:1-外包层;2-环氧树脂粘接层;3-光导纤维;3.1-光导纤维螺旋段;3.2-光导纤维平行段;4-内衬层;5-金属导丝;6-定位环。In all drawings, the same reference numerals are used to denote the same elements or structures, wherein: 1-outer cladding; 2-epoxy adhesive layer; 3-optical fiber; 3.1-optical fiber helical segment; 3.2- Optical fiber parallel segment; 4-inner lining; 5-metal guide wire; 6-positioning ring.
具体实施方式Detailed ways
为了使本发明的目的、技术方案及优点更加清楚明白,以下结合附图及实施例,对本发明进行进一步详细说明。应当理解,此处所描述的具体实施例仅仅用以解释本发明,并不用于限定本发明。此外,下面所描述的本发明各个实施方式中所涉及到的技术特征只要彼此之间未构成冲突就可以相互组合。In order to make the objectives, technical solutions and advantages of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention, but not to limit the present invention. In addition, the technical features involved in the various embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.
本发明提出一种变光纤螺旋角度的激光消融导管,通过对光导纤维的结构设计,达到使激光消融导管在血管中不同位置有更好力学性能的目的,提高激光消融导管的柔韧性,并保证导管的可操作性,降低对病人的身体损伤,适用于准分子激光冠脉斑块消融手术等医学场景。The invention proposes a laser ablation catheter with a variable fiber helix angle. Through the structural design of the optical fiber, the purpose of making the laser ablation catheter have better mechanical properties in different positions in the blood vessel is achieved, the flexibility of the laser ablation catheter is improved, and the The operability of the catheter reduces the physical damage to the patient, and is suitable for medical scenarios such as excimer laser coronary plaque ablation surgery.
具体的,如图1所示,一种变光纤螺旋角度的激光消融导管,该导管包括外包层1、光导纤维3、内衬层4、金属导丝5和定位环6。Specifically, as shown in FIG. 1 , a laser ablation catheter with a variable fiber helix angle includes an outer layer 1 , an
所述金属导丝5贯穿于所述内衬层4的腔内,所述外包层1和所述内衬层4均为圆筒形,二者同轴心平行,所述外包层1外侧和所述内衬层4内侧涂有润滑涂层,所述外包层1远端装有所述定位环6,所述外包层1和所述内衬层4之间包裹所述光导纤维3,用于传输激光。The
更进一步的说明,所述金属导丝5为食品级不锈钢材质。作为本发明优选实施例,所述金属导丝5的直径为0.008inch~0.014inch。For further explanation, the
更进一步的说明,所述外包层1和所述内衬层4采用无毒、无致敏、无致癌等副作用的聚四氟乙烯材料,表面润滑涂层采用聚乙烯吡咯烷酮等疏水材料。It is further explained that the outer layer 1 and the inner lining layer 4 are made of polytetrafluoroethylene material that is non-toxic, non-sensitizing, free of carcinogenic side effects, and the surface lubricating coating is made of hydrophobic materials such as polyvinylpyrrolidone.
更进一步的说明,所述内衬层4为所述金属导丝5提供移动通道,二者无公差配合关系。To further illustrate, the inner lining layer 4 provides a moving channel for the
更进一步的说明,激光消融导管的直径和长度设置不同尺寸规格,直径最小为1.4mm,最大为2.6mm,导管总长130cm至160cm不等,依据病人身体状况选择不同型号。To further explain, the diameter and length of the laser ablation catheter are set in different sizes. The minimum diameter is 1.4mm and the maximum is 2.6mm. The total length of the catheter ranges from 130cm to 160cm, and different models are selected according to the patient's physical condition.
更进一步的说明,所述光导纤维3从激光导管远端起30cm处为光导纤维螺旋段3.1,节距5cm,剩余部分为光导纤维平行段3.2;光导纤维为两层同轴平行排布,采用环氧树脂与将所述光导纤维3与所述外包层1和所述内衬层4粘接。To further illustrate, the
更进一步的说明,所述定位环6安装在激光消融导管远端端面处,为不透X光材质,如铅等,外层涂有疏水涂层。For further explanation, the
通过该导管结构设计,达到使激光消融导管在血管中不同位置有更好力学性能的目的,提高激光导管的柔韧性,并保证导管的可操作性,降低对病人的身体损伤,适用于准分子激光冠脉斑块消融手术等医学场景。Through the structural design of the catheter, the purpose of improving the mechanical properties of the laser ablation catheter at different positions in the blood vessel is achieved, the flexibility of the laser catheter is improved, the operability of the catheter is ensured, and the physical damage to the patient is reduced. It is suitable for excimer Medical scenarios such as laser coronary ablation surgery.
本发明的实施例中,所述激光消融导管为进入人体主动脉的工作部分,体外部分连接有金属导丝接入口、导管延伸部分和耦合器,耦合器插入准分子激光器上,激光器产生的激光经光导纤维传输沿着导管到达病灶位置。为便于医生操作,还可以在导管工作部分的近端安装定向手柄和握把等零件。以上附带零件均为现有产品,不在赘述。In the embodiment of the present invention, the laser ablation catheter is a working part that enters the human aorta, and the external part is connected with a metal guide wire access port, a catheter extension part and a coupler. The coupler is inserted into the excimer laser, and the laser generated by the laser is Transmission via the optical fiber follows the catheter to the lesion site. In order to facilitate the operation of the doctor, parts such as a directional handle and a handle can also be installed at the proximal end of the working part of the catheter. The above attached parts are all existing products and will not be repeated here.
在实施准分子激光冠脉斑块消融术时,先将金属导丝经穿刺鞘通入主动脉,随后通入激光消融导管,使其随着金属导丝移动,通过造影定位技术,可以看到激光消融导管的位置,到冠状动脉阻塞病灶处后,激光器开始工作,产生的脉冲激光对斑块进行消融,达到治疗目的。When performing excimer laser coronary plaque ablation, the metal guide wire is first introduced into the aorta through the puncture sheath, and then the laser ablation catheter is introduced to move with the metal guide wire. After the laser ablation catheter reaches the coronary artery occlusion lesion, the laser starts to work, and the generated pulsed laser ablates the plaque to achieve the purpose of treatment.
本领域的技术人员容易理解,以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等,均应包含在本发明的保护范围之内。Those skilled in the art can easily understand that the above are only preferred embodiments of the present invention, and are not intended to limit the present invention. Any modifications, equivalent replacements and improvements made within the spirit and principles of the present invention, etc., All should be included within the protection scope of the present invention.
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
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CN115032738A (en) * | 2022-06-27 | 2022-09-09 | 上海昊量光电设备有限公司 | Hollow optical fiber bundle, optical fiber bundle laser device and processing and manufacturing method thereof |
CN116025867A (en) * | 2023-01-03 | 2023-04-28 | 南京春辉科技实业有限公司 | Optical fiber illumination light guide rod |
WO2024245196A1 (en) * | 2023-05-29 | 2024-12-05 | 上海微创旋律医疗科技有限公司 | Laser ablation catheter and processing method therefor, and laser ablation system |
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US5415653A (en) * | 1992-08-26 | 1995-05-16 | Advanced Interventional Systems, Inc. | Optical catheter with stranded fibers |
US20180344528A1 (en) * | 2017-05-30 | 2018-12-06 | Novartis Ag | Multi-fiber multi-spot laser probe with articulating beam separation |
CN112998851A (en) * | 2021-02-26 | 2021-06-22 | 华中科技大学 | High-flexibility low-loss ablation laser catheter for coronary heart disease treatment |
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US5415653A (en) * | 1992-08-26 | 1995-05-16 | Advanced Interventional Systems, Inc. | Optical catheter with stranded fibers |
US20180344528A1 (en) * | 2017-05-30 | 2018-12-06 | Novartis Ag | Multi-fiber multi-spot laser probe with articulating beam separation |
CN112998851A (en) * | 2021-02-26 | 2021-06-22 | 华中科技大学 | High-flexibility low-loss ablation laser catheter for coronary heart disease treatment |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN115032738A (en) * | 2022-06-27 | 2022-09-09 | 上海昊量光电设备有限公司 | Hollow optical fiber bundle, optical fiber bundle laser device and processing and manufacturing method thereof |
CN115032738B (en) * | 2022-06-27 | 2023-10-20 | 上海昊量光电设备有限公司 | Hollow optical fiber bundle, optical fiber bundle laser device and processing and manufacturing method thereof |
CN116025867A (en) * | 2023-01-03 | 2023-04-28 | 南京春辉科技实业有限公司 | Optical fiber illumination light guide rod |
CN116025867B (en) * | 2023-01-03 | 2023-09-29 | 南京春辉科技实业有限公司 | Optical fiber illumination light guide rod |
WO2024245196A1 (en) * | 2023-05-29 | 2024-12-05 | 上海微创旋律医疗科技有限公司 | Laser ablation catheter and processing method therefor, and laser ablation system |
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