WO2018120451A1 - 一种血管光纤导丝 - Google Patents

一种血管光纤导丝 Download PDF

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Publication number
WO2018120451A1
WO2018120451A1 PCT/CN2017/077668 CN2017077668W WO2018120451A1 WO 2018120451 A1 WO2018120451 A1 WO 2018120451A1 CN 2017077668 W CN2017077668 W CN 2017077668W WO 2018120451 A1 WO2018120451 A1 WO 2018120451A1
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Prior art keywords
wire
core
fiber
light
optical fiber
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PCT/CN2017/077668
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English (en)
French (fr)
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尚华
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尚华
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Priority to US15/605,240 priority Critical patent/US10639496B2/en
Publication of WO2018120451A1 publication Critical patent/WO2018120451A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0613—Apparatus adapted for a specific treatment
    • A61N5/062—Photodynamic therapy, i.e. excitation of an agent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0601—Apparatus for use inside the body
    • A61N5/0603—Apparatus for use inside the body for treatment of body cavities
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/063—Radiation therapy using light comprising light transmitting means, e.g. optical fibres

Definitions

  • the invention relates to the technical field of medical instruments, in particular to a blood vessel fiber guide wire which can be treated into a human body through a blood vessel such as an artery to realize a treatment of a photodynamic tumor or the like.
  • the Seldinger arterial intubation technique is very mature. Under the guidance of clinical imaging medicine (X-ray, CT, MR, B-us, etc.), the technique is to insert a special device such as a catheter or a guide wire into the lesion through a percutaneous puncture vascular approach or an original human orifice. Diagnostic imaging and treatment.
  • the technique uses a metal guide wire to percutaneously penetrate a blood vessel to enter a blood vessel to reach a lesion.
  • the method is simple in operation, small in damage, and does not require suturing a blood vessel, completely replacing the method of surgically cutting open blood vessels, and becomes a basic operation technique of modern interventional radiology.
  • the tissue is mainly caused by embolization caused by ischemia-anoxic necrosis or perfusion of drugs to inhibit cell growth or release of implanted medical devices to change the shape of organs, and it is impossible to introduce light into blood vessels and the body or Lead to blood vessels and in vitro.
  • tumor photodynamic therapy has many advantages such as small trauma, low toxicity, good targeting and good applicability, but the illumination method is limited to the body surface or thicker channels due to Limited by the laser emission mechanism and the performance of the photosensitizer, its photodynamic power is only a few millimeters, which greatly limits its application in the medical field.
  • the invention adopts a wrap wire and a hydrophilic coating to wrap the optical fiber, and constitutes a vascular fiber guide wire of various lengths and diameters, and uses the device to enter the blood vessel, and introduces and guides the light through the fiber core wire to the lesion portion. It meets the dual effects of diagnosis and treatment of light introduction and extraction of blood vessels in the fields of biology and medical treatment.
  • the catheter guide wire for the Seldinger arterial cannulation technique cannot transmit light energy, and the photodynamic therapy cannot reach the defect of the lesion in the body.
  • the object of the present invention is to provide a vascular fiber guide wire through which the fiber guide wire enters the body. The introduction and extraction of light from the lesion overcomes the problem that the guidewire cannot guide light and photodynamic therapy cannot reach the body.
  • a vascular fiber guidewire comprising at least one fiber core wire for conducting light, a wire layer and a hydrophilic coating capable of improving body fluid compatibility and reducing resistance; the fiber core wire being disposed on the fiber guide At the axial center of the wire; the wire layer is composed of at least one wire or wound sheet wrapped around the periphery of the fiber core; the hydrophilic coating is applied to the periphery of the wire layer.
  • the optical fiber core wire includes a core and a cladding applied to a periphery of each of the cores, the cladding having a light conductivity less than the core.
  • the optical fiber guide wire preferably includes two or more optical fiber core wires, and the optical fiber core wire includes both a first core capable of introducing light and a second core capable of deriving light.
  • the core is a single mode core or a multimode core
  • the core material is at least one of a quartz core, a polymer core or a metal hollow core.
  • one or more metal/polymer guide wires can be added to the core in parallel with the core to increase the strength thereof.
  • hydrophilic coating is made of a chemically stable material.
  • the material of the hydrophilic coating layer comprises polytetrafluoroethylene, silicone rubber, polyethylene, polyvinyl chloride, fluorocarbon polymer and polyurethane.
  • the wire comprises a metal wire and a non-metal wire.
  • the wire comprises at least one of a stainless steel wire, a synthetic fiber wound wire, a carbon fiber wound wire, a platinum wire wound wire, and a titanium alloy wire.
  • the wire is tightly wound around the periphery of the fiber core to restrain light in the core of the fiber.
  • the end of the optical fiber guide wire that is introduced into one end of the blood vessel is provided with a light guiding portion, and the light guiding portion includes a light transmitting portion and a tip disposed at the top end of the light transmitting portion and capable of coupling light out/into the core.
  • the light transmitting portion is provided with a plurality of light guiding holes penetrating the hydrophilic coating and the winding layer and perpendicular to the optical fiber core.
  • the length of the light transmitting portion is generally 1 to 4 cm, preferably 2 to 3 cm.
  • microlens may be a hemispherical structure that protrudes outward.
  • the other end of the optical fiber guide wire is connected with an optical coupler, and the optical coupler is provided with an operating rod.
  • the fiber guide wire has a diameter of from 90 ⁇ m to 2000 ⁇ m, preferably from 100 ⁇ m to 1000 ⁇ m.
  • the length of the fiber guide wire is 1.5 to 2 m.
  • the optical fiber guide wire of the present invention can enter the body through a blood vessel or the like, even if the optical fiber guide wire enters a predetermined lesion position in the blood vessel, and introduces and extracts light to the lesion site, thereby exerting therapeutic and diagnostic effects, such as causing photosensitizer drugs to occur. effect.
  • the provision of a hydrophilic coating on the outermost layer of the fiber guide wire can improve blood compatibility and reduce resistance in the blood; the specific arrangement of the wire wound in the wire layer can improve the toughness and strength, and contribute to the fiber guide.
  • the silk enters the inside of the human body, and its specific winding method also has certain auxiliary effects for entering the inside of the human body; adding one or more metal/polymer guide wires to the core can further increase its strength, making the optical fiber guide wire easier to screw into the human body.
  • the arrangement of the specific structure of the light transmissive portion contributes to the treatment, and the arrangement of the microlens can further reduce the resistance of the optical fiber guide wire to travel through the blood vessel.
  • the setting of the operating rod facilitates the screwing of the fiber guide wire into the lesion of the human blood vessel.
  • FIG. 1 is a schematic structural view showing a portion of an optical fiber guide wire according to an embodiment of the present invention
  • FIG. 2 is a schematic cross-sectional structural view of an optical fiber guide wire according to an embodiment of the present invention.
  • Figure 3 is a cross-sectional view of the inner portion of the dotted circle of Figure 1;
  • FIG. 4 is a schematic view showing the overall structure of an optical fiber guide wire according to an embodiment of the present invention.
  • FIG. 5 is a schematic cross-sectional structural view of an optical fiber guide wire according to another embodiment of the present invention.
  • FIG. 6 is a schematic structural view of a winding method of a fiber in a fiber guide wire according to an embodiment of the present invention
  • FIG. 7 is a schematic structural view of a plurality of winding wires in an optical fiber guide wire according to an embodiment of the present invention.
  • FIG. 8 is a structural schematic view showing a wrapping and wrapping of a wound sheet in an optical fiber guide wire according to an embodiment of the present invention.
  • a vascular fiber guidewire 10 includes an optical fiber core wire, a wound wire layer 13 wrapped around a periphery of the optical fiber core wire, and coated on the wire. a hydrophilic coating 14 on the periphery of layer 13;
  • An optical fiber core wire is disposed at an axial center of the optical fiber guide wire 10, the optical fiber core wire including a core 11 (ie, an optical fiber) for conducting light, and a cladding 12 coated on a periphery of the core 11, the core 11 For Single mode core or multimode core.
  • the core 11 is made of at least one of a quartz core, a polymer core, and a metal hollow core.
  • the cladding 12 has a lower optical conductivity than the core 11, and therefore, the cladding 12 has a certain binding force to the light in the core 11.
  • the wire-wound layer 13 is composed of at least one wrap or wrap sheet 131 wrapped around the periphery of the fiber core wire; the wrap wire 131 is wound around the periphery of the fiber core wire to improve its toughness and strength. Typically, the wire 131 is tightly wound around the periphery of the fiber core to constrain light in the core of the fiber.
  • the hydrophilic coating 14 is configured to increase humoral compatibility and reduce resistance of the fiber guidewire 10 in the body, such as improving blood compatibility and reducing resistance in the blood.
  • the hydrophilic coating 14 is chemically stable. Made of materials.
  • the material of the hydrophilic coating 14 includes, but is not limited to, polytetrafluoroethylene, silicone rubber, polyethylene, polyvinyl chloride, fluorocarbon polymer and polyurethane, and the hydrophilic coating 14 may be composed of any of the above materials or two. The above mixture is composed.
  • the hydrophilic coating 14 may be disposed outside the wound layer 13 by coating, coating or heat shrinking.
  • the end of the optical fiber guide wire 10 that is introduced into one end of the human blood vessel is provided with a light guiding portion 20, and the light guiding portion 20 includes a light transmitting portion and is disposed at a top end of the light transmitting portion (ie, a fiber guide).
  • the light transmitting portion is provided with a plurality of light guiding holes 16 penetrating the hydrophilic coating layer 14 and the winding wire layer 13 and perpendicular to the fiber core wires, through which the optical fiber core wires can be exposed, that is, through the holes
  • the apertures are directly visible to the core of the fiber, and a small portion of the light in the core 11 passes through the cladding 12 and exits from the apertures 16.
  • the length of the light transmitting portion is generally from 1 to 4 cm, preferably from 2 to 3 cm, which contributes to the treatment and advancement of the optical fiber guide wire 10.
  • the light guiding hole 16 at the light transmitting portion can be realized by winding the wire 131, for example, the winding wire 131 is not tightly wound, as shown in FIG. 7, that is, a gap is formed between the adjacent wires 131, and then the hydrophilic coating is provided. 14 is directly applied to the wire 131, and a gap between the wire 131 and the wire 131 is still present to form the light guiding hole 16.
  • the portion of the optical fiber guide wire 10 other than the light transmitting portion is preferably tightly wound around the wire 131 to ensure the strength of the optical fiber guide wire 10 while also preventing light from leaking.
  • the microlens 15 is a circular, hemispherical or the like structure, and it is easy to concentrate light or heat, and the arrangement of the microlens 15 further reduces the resistance of the optical fiber guide wire 10 to travel through the blood vessel.
  • the microlens 15 can also be of other construction types.
  • the other end of the optical fiber guide wire 10 that is, the end of the external optical body for user operation is connected with an optical coupler 30.
  • the optical coupler 30 is rotatable, and the optical coupler 30 is externally disposed.
  • the operable operating rod rotates the fiber guide wire 10 into a predetermined position in the blood vessel by a rotating operation, that is, the user can screw the optical fiber guide wire 10 into the lesion portion of the blood vessel to illuminate, and can couple the optical fiber into/out of the optical fiber guide wire. 10, to play a diagnostic and therapeutic effect.
  • one or more metal/polymer guide wires can be added to the core 11 in parallel with the core 11 to increase the strength thereof.
  • the number of the optical fiber core wires in Embodiment 1 may be two or more and arranged side by side at the axial center of the optical fiber guide wire 10.
  • the optical fiber core wire includes a core 11 and is coated on each core. 11
  • the outer cladding 12, the winding wire around the wire layer 13 is wound around the periphery of all the fiber core wires to improve its toughness and strength.
  • the cladding 12 has a lower optical conductivity than the core 11, and therefore, the cladding 12 has a certain binding force to the light in the core 11.
  • the core 11 can include both a first core capable of introducing light and a second core capable of deriving light, that is, in the case of a plurality of cores 11
  • the light can be introduced by one or more cores, and the light is derived by using one or more cores, and the core of the derived light can be derived by using a computer or the like by deriving the light after the action in the blood vessel. Analysis of the spectrum of light, etc., can help to understand the treatment situation or condition, and take appropriate treatments for diagnosis and treatment.
  • the winding method of the winding wire 131 can be performed by one A metal or non-metal wire having a diameter of the order of tens of microns is spirally wound around the periphery of the fiber core by a tight arrangement.
  • the winding wire 131 may also be wound around the outer periphery of the optical fiber core by two winding wires 131, and the two winding wires 131 are wound by knitting to form a wound wire layer 13 composed of two layers of the wound wire 131.
  • the winding wire 131 may also be a wrapping sheet, and the winding sheet is wrapped around the periphery of the optical fiber core.
  • the wrapping sheet can also be formed by a metal tube/film method to form a soft structural package such as a hypotube.
  • the winding manner of the wound wire or the wound sheet 131 is not limited to the above.
  • the material of the wire or wound sheet 131 includes a metal wire and/or a non-metal wire.
  • the material of the wire or the wound piece 131 includes but is not limited to the following: stainless steel wire, synthetic fiber wire, Carbon fiber wound wire, white gold wire and titanium alloy wire, wire or wound sheet can be used in any of these types or several of them can be used at the same time.
  • the winding wire 131 in the winding layer 13 may be a single layer or more than two layers, the material is a metal and/or a non-metal material, and the structure of the winding wire 131 is a filament, a sheet or a tube, and the wrapping method may be a coating. , winding or weaving.
  • the specification of the wire 140 can be selected to be larger or smaller than the wire 131 according to actual conditions.
  • the interventional treatment is a liver tumor
  • the laser emitting device and the optical fiber guide wire 10 are connected together through the optical coupler 30.
  • the fiber guide wire 10 is provided with one end of the microlens 15 to be punctured into the blood vessel, and under the guidance of the clinical image, the hand end is rotated to gradually screw the fiber guide wire 10 into the lesion of the blood vessel in the liver tumor.
  • the laser emitting device is turned on, and the laser is guided through the optical fiber core wire to irradiate the tumor tumor body which has been injected with the photosensitive drug, so that the photochemical reaction of the photosensitive drug in the tumor produces singlet oxygen, which in turn causes necrosis and apoptosis of the tumor tumor body, thereby achieving The purpose of treating tumors.
  • the optical fiber guide wire 10 of the present invention has a diameter of only one hundred micrometers, and generally has a maximum diameter of about 2 mm and a minimum diameter of only about 100 ⁇ m. Therefore, it can be inserted into a human body through a blood vessel or the like for interventional treatment.
  • the length of the fiber guide wire 10 is generally 1.5 to 2 m, and the light source can be transmitted to almost any lesion in the human body, and 0.4 to 1 m is generally reserved in vitro.
  • the number of semiconductor lasers 4 is selected according to actual needs, and the adjustment of a wide range of wavelengths is achieved by selecting the semiconductor laser 4, and then according to the correspondence between the wavelength and the temperature, the precise range of wavelengths can be adjusted to achieve the final temperature by adjusting the temperature.
  • Output wavelength In the specific implementation, the temperature change of the semiconductor refrigerating sheet 5 can be converted into a wavelength indication, which is convenient for the user to adjust.

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Abstract

一种血管光纤导丝（10），光纤导丝（10）包括至少一根光纤芯丝、绕丝层（13）和能够提高体液相容性并减少阻力的亲水涂层（14），光纤芯丝设置于光纤导丝（10）的轴心处；绕丝层（13）由至少一根包裹环绕于光纤芯丝外围的绕丝或缠绕片（131）构成；亲水涂层（14）涂覆于绕丝层（13）的外围。光纤导丝（10）可进入人体动脉血管内预定位置，将光引入和/或引出病变部位实现体内肿瘤等光动力学治疗，以满足生物、医疗等领域的诊断和治疗需求。

Description

一种血管光纤导丝 技术领域
本发明涉及医疗器械技术领域，具体涉及一种可通过动脉等血管进入人体内实现光动力学肿瘤等疾病治疗的血管光纤导丝。
背景技术
目前，Seldinger动脉插管技术已经非常成熟。该技术在临床影像医学(X-ray、CT、MR、B-us等)引导下，通过经皮穿刺血管途径或人体原有孔道，将特制的导管、导丝等细微器械插至病变部位进行诊断性造影和治疗。该技术采用金属导丝经皮穿刺血管途径进入血管抵达病变部位，该方法操作简单、损伤小、无需缝合血管，完全替代了以往手术切开暴露血管的方法，成为现代介入放射学的基本操作技术，在肿瘤的供血栓塞与药物灌注、动脉内照射、放射性损伤的预防、化疗、术前栓塞肿瘤血管、血管作用性药物及酒精等灌注取得了较好的效果。但是，由于受限于治疗方式的局限性，基本上以栓塞造成组织缺血缺氧坏死或灌注药物抑止细胞生长或释放植入医疗器械改变器官组织形态为主，无法将光引入血管及体内或引出血管及体外。
肿瘤光动力疗法与手术、化疗、放疗等常规治疗手段相比，具有创伤小、毒性低微、靶向性好、适用性好的诸多优点，但是光照方式局限于体表或较粗的孔道，由于受到激光发射机制和光敏剂药物性能的限制，其光动力仅有几毫米作用范围，大大限制了其在医学领域的应用。目前还没有办法将光通过血管引入体内进行诊断和治疗。本发明采用绕丝和亲水涂层包裹光纤，组成可操纵的多种长度和直径的血管光纤导丝，利用该装置进入血管，通过光纤芯丝将光引入和引出血管抵近病变部位，可满足生物、医疗等领域对光引入和引出血管需求，起到诊断和治疗的双重效果。
发明内容
针对Seldinger动脉插管技术的导管导丝无法传递光能，以及光动力治疗无法抵近体内病变部位的不足，本发明的目的是提供一种血管光纤导丝，光纤导丝通过血管进入体内，将光引入和引出病变部位，克服了导丝无法导光和光动力治疗无法抵近体内的问题。
本发明的目的是通过以下技术方案来实现：
一种血管光纤导丝，包括用于传导光的至少一根光纤芯丝、绕丝层和能够提高体液相容性并减少阻力的亲水涂层；所述光纤芯丝设置于所述光纤导丝的轴心处；所述绕丝层由至少一根包裹环绕于所述光纤芯丝外围的绕丝或缠绕片构成；所述亲水涂层涂覆于所述绕丝层的外围。
进一步地，所述光纤芯丝包括纤芯以及涂覆于每根所述纤芯外围的包层，所述包层的光传导率小于所述纤芯。
进一步地，所述光纤导丝优选包括两根以上的光纤芯丝，则光纤芯丝同时包括能够导入光的第一纤芯和能导出光的第二纤芯。
进一步地，所述纤芯为单模纤芯或多模纤芯；
进一步地，所述纤芯的材质为石英纤芯、聚合物纤芯或和金属空心纤芯中的至少一种。
进一步地，所述纤芯中还能够加入一根或多根金属/聚合物导丝与所述纤芯并行排列以提高其强度。
进一步地，所述亲水涂层为采用化学稳定的材料制成。
进一步地，所述亲水涂层的材料包括聚四氟乙烯、硅橡胶、聚乙烯、聚氯乙烯、氟碳聚合物和聚氨酯。
进一步地，所述绕丝包括金属绕丝和非金属绕丝。
进一步地，所述绕丝包括不锈钢绕丝、合成纤维绕丝、碳纤维绕丝、白金绕丝和钛合金绕丝中的至少一种。
进一步地，所述绕丝紧密缠绕在所述光纤芯丝外围以使光纤芯丝中的光得到约束。
进一步地，所述光纤导丝上导入血管一端的端头设有导光部，所述导光部包括透光部以及设置于所述透光部顶端并能够将光耦合出/入纤芯的微透镜；所述透光部上设有多个贯穿所述亲水涂层和绕丝层、并垂直所述光纤芯丝的导光孔。
进一步地，所述透光部的长度一般为1～4cm，优选2～3cm。
进一步地，所述微透镜可为向外凸出的半球型结构。
进一步地，所述光纤导丝的另一端连接有光耦合器，所述光耦合器上设有操作杆。
所述光纤导丝的直径为90μm～2000μm，优选100μm～1000μm。
所述光纤导丝的长度为1.5～2m。
本发明至少具有以下有益效果：
本发明中的光纤导丝可通过血管等进入体内，即使该光纤导丝在血管内进入预定的病变位置，将光引入和引出病变部位从而起到治疗和诊断效果，如使光敏剂药物等发生作用。
具体地，在光纤导丝的最外层设置亲水涂层能够提高血液相容性并减少在血液中的阻力；绕丝层中绕丝的具体设置可提高韧性和强度，有助于光纤导丝进入人体内部，其具体缠绕方式对于进入人体内部也有一定的辅助作用；纤芯中加入一根或多根金属/聚合物导丝也可以进一步提高其强度，使光纤导丝更容易旋入人体；透光部具体结构的设置有助于治疗，微透镜的设置也可以进一步减小光纤导丝在血管内穿行的阻力。操作杆的设置有利于将光纤导丝旋入人体血管的病变部位。
附图说明
图1是本发明实施例所述的部分光纤导丝剖开的结构示意图；
图2是本发明实施例所述的光纤导丝的横截面结构示意图；
图3是图1中虚线圈内部分的剖面图；
图4是本发明实施例所述的光纤导丝的整体结构示意图；
图5是本发明另一个实施例所述的光纤导丝的横截面结构示意图；
图6是本发明实施例所述的光纤导丝中绕丝缠绕方式的结构示意图；
图7是本发明实施例所述的光纤导丝中多根绕丝缠绕方式的结构示意图；
图8是本发明实施例所述的光纤导丝中缠绕片包裹缠绕的结构示意图。
10、光纤导丝，11、纤芯，12、包层，13、绕丝层，14、亲水涂层，15、微透镜，16、导光孔，20、导光部，30、光耦合器，131、绕丝或/缠绕片。
具体实施方式
下面对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例是本发明一部分实施例，而不是全部的实施例。以下提供的本发明的实施例的详细描述并非旨在限制要求保护的本发明的范围，而是仅仅表示本发明的选定实施例。基于本发明中的实施例，本领域普通方法人员在没有作出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
实施例1
如图1～2所示，一种血管光纤导丝，所述光纤导丝10包括一根光纤芯丝、包裹环绕于所述光纤芯丝外围的绕丝层13以及涂覆于所述绕丝层13的外围的亲水涂层14；
光纤芯丝设置于所述光纤导丝10的轴心处，所述光纤芯丝包括用于传导光的纤芯11(即光纤)以及涂覆于纤芯11外围的包层12，纤芯11为 单模纤芯或多模纤芯。所述纤芯11的材质为石英纤芯、聚合物纤芯或和金属空心纤芯中的至少一种。所述包层12的光传导率小于所述纤芯11，因此，该包层12对纤芯11中的光有一定的约束力。
绕丝层13由至少一根包裹环绕于所述光纤芯丝外围的绕丝或缠绕片131构成；绕丝131缠绕于光纤芯丝的外围可提高其韧性和强度。通常所述绕丝131紧密缠绕在所述光纤芯丝外围以使光纤芯丝中的光得到约束。
亲水涂层14的设置能够提高体液相容性并减少光纤导丝10在体内穿行的阻力，如提高血液相容性并减少在血液中的阻力，该亲水涂层14为采用化学稳定的材料制成。
亲水涂层14的材料包括但不限于聚四氟乙烯、硅橡胶、聚乙烯、聚氯乙烯、氟碳聚合物和聚氨酯，亲水涂层14可采用上述任何一种材料构成也可以为两种以上的混合物构成。亲水涂层14可由镀膜、涂敷或热缩等方式设置于绕丝层13外。
如图3所示，所述光纤导丝10上导入人体血管一端的端头设有导光部20，所述导光部20包括透光部以及设置于所述透光部顶端(即光纤导丝10的顶端)并能够将光耦合出/入纤芯11的微透镜15，则光纤芯丝从光纤导丝10的主体部分一直延伸至透光部，然后光纤芯丝中传导的光从微透镜15处汇聚传出光纤导丝10，并照射在需要光的部位。所述透光部上设有多个贯穿所述亲水涂层14和绕丝层13、并垂直所述光纤芯丝的导光孔16，通过这些孔可以将光纤芯丝暴露，即通过这些孔可直接看到光纤芯丝，纤芯11中的光有一小部分会穿过包层12并从这些导光孔16传出。所述透光部的长度一般为1～4cm，优选2～3cm，则有助于治疗以及光纤导丝10的前行。
上述透光部处的导光孔16可以通过绕丝131缠绕方式实现，如绕丝131缠绕不紧密，如图7所示，即相邻绕丝131之间设有缝隙，然后亲水涂层14直接涂在绕丝131上，绕丝131与绕丝131之间的缝隙仍然存在，形成导光孔16。
除了透光部之外的其他光纤导丝10部分，优选为绕丝131紧密缠绕，保证光纤导丝10的强度的同时也使光不泄露。
所述微透镜15为向圆型、半球形等结构，容易汇聚光线或热量，且该微透镜15的设置也进一步减小光纤导丝10在血管内穿行的阻力。当然，微透镜15也可以为其他结构类型。
如图4所示，所述光纤导丝10的另一端，即留在体外供使用者操作的一端连接有光耦合器30，优选该光耦合器30可旋转，该光耦合器30外设有可操作的操作杆，通过旋转操作使光纤导丝10在血管内进入预定位置，即方便使用者将光纤导丝10旋入血管的病变部位进行光照，同时能够将光耦入/出光纤导丝10，起到诊断和治疗效果。
作为进一步优选的实施方式，所述纤芯11中还能够加入一根或多根金属/聚合物导丝与所述纤芯11并行排列以提高其强度。
实施例2
如图5所示，实施例1中光纤芯丝的数量可以为两根或两根以上并排设置于光纤导丝10的轴心处，光纤芯丝包括纤芯11以及涂覆于每根纤芯11外围的包层12，绕丝层13中的绕丝缠绕于所有光纤芯丝的外围以提高其韧性和强度。所述包层12的光传导率小于所述纤芯11，因此，该包层12对纤芯11中的光有一定的约束力。
若光纤导丝10中含有多根纤芯11，则所述纤芯11中可同时包括能够导入光的第一纤芯和能导出光的第二纤芯，即在多根纤芯11情况下，可采用一根/多根纤芯导入光，同时采用一根/多根纤芯导出光，则导出光的纤芯通过将在血管内发生作用后的光导出，便可采用计算机等对导出光的光谱等进行分析，有助于了解治疗情况或病情等，并采取相应的治疗手段进行诊治。
其他结构均与实施例1一致，这里不再重复限定。
实施例3
在实施例1的基础上，如图6所示，绕丝131的缠绕方式可由一根 直径为数十微米量级的金属或非金属绕丝通过紧密排列方式螺旋环绕于光纤芯丝外围。如图7所示，绕丝131也可以通过两根绕丝131缠绕于光纤芯丝外围，两根绕丝131通过编织方式进行缠绕形成由两层绕丝131构成的绕丝层13。当然，也可以采用多根金属/非金属绕丝按该方式缠绕。如图8所示，上述绕丝131还可以为缠绕片，将该缠绕片缠绕包裹于光纤芯丝外围。缠绕片也可采用金属管/膜方式，通过切割形成柔软结构包裹，如海波管。当然，绕丝或缠绕片131的缠绕方式不限于以上几种。
所述绕丝或缠绕片131的材质包括金属绕丝和/或非金属绕丝，具体地，绕丝或缠绕片131的材料包括但不仅限于以下几种：不锈钢绕丝、合成纤维绕丝、碳纤维绕丝、白金绕丝和钛合金绕丝，绕丝或缠绕片可以使用这几种中的任意一种也可以是其中的几种同时使用。
总之，绕丝层13中的绕丝131可为单层或两层以上，材料为金属和/或非金属材料，绕丝131的结构为丝状、片状或管状，包裹方式可为包覆、缠绕或编织等方式。
当然，在本实施例中，绕丝131的规格可根据实际情况选择更大规格或更小规格的绕丝131。
实施例4
在光动力肿瘤治疗中，若介入治疗的是肝脏肿瘤，需要进入肝脏肿瘤内血管。则将激光发射装置与光纤导丝10通过光耦合器30连接为一体。将光纤导丝10设有微透镜15的一端经皮穿刺进入血管，并在临床影像引导下，旋转手持一端将光纤导丝10逐渐旋入肝脏肿瘤内血管的病变部位。打开激光发射装置，将激光经光纤芯丝引导，照射在已注射光敏药物的肿瘤瘤体，使瘤体内的光敏药物发生光化学反应产生单态氧继而引发肿瘤瘤体的坏死及凋亡，从而达到治疗肿瘤的目的。
具体实施时，本发明的光纤导丝10直径仅有百微米量级，一般最大直径约为2mm，最小直径只有100μm左右，因此，能够通过血管等穿入人体内进行介入治疗。该光纤导丝10的长度一般为1.5～2m，几乎可对人体内任何的病变部位输送光源，一般体外预留0.4～1m。
具体使用时，根据实际需要选择半导体激光器4的数量，调整大范围波长便通过选择半导体激光器4来实现，然后根据波长和温度的对应关系，调整精确范围的波长便可通过调整温度来实现最终的输出波长。具体实施时，可将半导体制冷片5的温度变化换算成波长标示出来，方便使用者调节。
以上所述仅为本发明的优选实施例，并不用于限制本发明，对于本领域技术人员而言，本发明可以有各种改动和变化。凡在本发明的精神和原理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. 一种血管光纤导丝，其特征在于：所述光纤导丝包括：
    用于传导光的至少一根光纤芯丝，所述光纤芯丝设置于所述光纤导丝的轴心处；
    绕丝层，所述绕丝层由至少一根包裹环绕于所述光纤芯丝外围的绕丝构成；
    和能够提高体液相容性并减少阻力的亲水涂层，所述亲水涂层涂覆于所述绕丝层的外围。
  2. 根据权利要求1所述的血管光纤导丝，其特征在于：所述光纤芯丝包括纤芯以及涂覆于每根所述纤芯外围的包层，所述包层的光传导率小于所述纤芯。
  3. 根据权利要求1所述的血管光纤导丝，其特征在于：所述纤芯中还能够加入一根或多根金属导丝或聚合物导丝与所述纤芯并行排列以提高其强度。
  4. 根据权利要求1所述的血管光纤导丝，其特征在于：所述光纤导丝包括两根以上的光纤芯丝，该光纤芯丝同时包括能够导入光的第一纤芯和能导出光的第二纤芯；
    所述绕丝紧密缠绕在所述光纤芯丝外围以使光纤芯丝中的光得到约束。
  5. 根据权利要求1所述的血管光纤导丝，其特征在于：所述亲水涂层由化学稳定的材料制成；
    所述绕丝包括金属绕丝和非金属绕丝；
    所述纤芯为单模纤芯或多模纤芯；所述纤芯的材质为石英纤芯、聚合物纤芯或金属空心纤芯中的至少一种。
  6. 根据权利要求5所述的血管光纤导丝，其特征在于：所述亲水涂 层的材料包括聚四氟乙烯、硅橡胶、聚乙烯、聚氯乙烯、氟碳聚合物和聚氨酯中的至少一种；
    所述绕丝包括不锈钢绕丝、合成纤维绕丝、碳纤维绕丝、白金绕丝和钛合金绕丝中的至少一种。
  7. 根据权利要求6所述的血管光纤导丝，其特征在于：所述光纤导丝上导入血管一端的端头设有导光部，所述导光部包括透光部以及设置于所述透光部顶端并能够将光耦合出/入纤芯的微透镜；所述透光部上设有多个贯穿所述亲水涂层和绕丝层、并垂直所述光纤芯丝的导光孔。
  8. 根据权利要求7所述的血管光纤导丝，其特征在于：所述光纤导丝留在体外供使用者操作的一端连接有光耦合器，所述光耦合器上设有操作杆。
  9. 根据权利要求1～8中任一项所述的血管光纤导丝，其特征在于：所述光纤导丝的直径为90μm～2000μm，优选100μm～1000μm。
  10. 根据权利要求9所述的血管光纤导丝，其特征在于：所述光纤导丝的长度为1m～2m。
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