阅读说明：本技术 环形芯与传像束集成的医用光纤及其制备方法 (Medical optical fiber integrating annular core and image transmission bundle and preparation method thereof ) 是由 苑立波 杨世泰 于 2021-08-26 设计创作，主要内容包括：本发明提供的是环形芯与传像束集成的医用光纤,其特征是：该医用光纤包含一个环形芯、氟掺杂的环形隔离层、中间密集排布的传像阵列纤芯、石英公共包层以及最外层的硅树脂保护涂覆层。该医疗光纤可介入人体血管内部,其中环形芯能够传输照明光束和手术光束,中间的传像阵列纤芯能够传输血管内的图像。除此之外,本发明还提供了该医用光纤的制备方法。本发明可用于血管内肿瘤或血栓等病变区域的成像及手术,在心血管疾病的治疗领域有广泛应用。(The invention provides a medical optical fiber integrating a ring-shaped core and an image transmission bundle, which is characterized in that: the medical optical fiber comprises an annular core, a fluorine-doped annular isolation layer, image transmission array fiber cores densely arranged in the middle, a quartz common cladding and an outermost silicone resin protective coating layer. The medical optical fiber can be inserted into a blood vessel of a human body, wherein the annular core can transmit illumination light beams and operation light beams, and the fiber core of the image transmission array in the middle can transmit images in the blood vessel. In addition, the invention also provides a preparation method of the medical optical fiber. The invention can be used for imaging and operating pathological change areas such as tumors or thrombi in blood vessels and the like, and has wide application in the treatment field of cardiovascular diseases.)

1. The ring core and image transmission bundle integrated medical optical fiber is characterized in that: the medical optical fiber comprises an annular core, a fluorine-doped annular isolation layer, image transmission array fiber cores densely arranged in the middle, a quartz common cladding and an outermost silicone resin protective coating layer.

2. The ring core and image bundle integrated medical fiber of claim 1, wherein: the diameter of the medical optical fiber is 400-500 microns, and the diameter of the coating layer is 500-600 microns.

3. The ring core and image bundle integrated medical fiber of claim 1, wherein: the overall diameter of the image transmission array fiber cores densely arranged in the middle is 350-450 micrometers, and the number of the array fiber cores is 6000-10000.

4. The ring core and image bundle integrated medical optical fiber according to any one of claims 1 to 3, wherein: the image transmission array fiber cores densely distributed in the middle are densely distributed fiber cores distributed in a regular hexagon, the diameters of the adjacent fiber cores of each fiber core are different, and the outer layer of each fiber core is a fluorine-doped cladding and a quartz cladding.

5. The ring core and image bundle integrated medical fiber of claim 1, wherein: the fluorine-doped annular isolation layer is arranged between the annular core and the image transmission array fiber core, and the annular core, the image transmission array fiber core and the image transmission array fiber core are coaxially distributed.

6. The preparation method of the medical optical fiber integrating the annular core and the image transmission bundle is characterized in that:

step 1: taking a thin-wall quartz tube, and sequentially depositing a germanium-doped annular core and a fluorine-doped annular isolating layer in the tube to form an annular prefabricated sleeve;

step 2: taking at least four thin-wall quartz tubes, depositing a fluorine-doped cladding layer and a germanium-doped fiber core layer in sequence inside the thin-wall quartz tubes, and then collapsing the tubes at high temperature to form at least four image-transmitting fiber core prefabricated rods, wherein the outer diameter of each image-transmitting fiber core prefabricated rod is the same, but the diameters of the germanium-doped fiber cores are different;

and step 3: pulling the image transmission fiber core prefabricated rod prepared in the step 2 at high temperature to prepare an image transmission unit prefabricated component with the same outer diameter and different core diameter diameters, and cutting the prefabricated component into multiple sections with equal length;

and 4, step 4: taking a thin-wall quartz tube, arranging the image transmission unit prefabricated members drawn in the step 3 in the tube according to regular hexagon close packing, wherein the diameters of fiber cores of each image transmission unit prefabricated member and adjacent prefabricated members are different, and filling quartz rods with proper diameters are inserted into gaps between the regular hexagons and the quartz tube;

and 5: pumping the pile body obtained in the step (4) at high temperature to shrink the rod, forming a solid prefabricated rod, and then drawing at high temperature to form an image transmission unit array prefabricated part;

step 6: taking a thin-wall quartz tube, densely arranging the image transmission unit array prefabricated members in the step 5 in the tube, shrinking the rod at high temperature, drawing the image transmission unit array prefabricated members with higher fiber core density again, and repeating the step until obtaining an array fiber core prefabricated member of which the number of the image transmission array fiber cores meets the requirement and the outer diameter is equal to the inner diameter of the annular prefabricated sleeve in the step 1;

and 7: and (3) inserting the array fiber core prefabricated rod obtained in the step (6) into the annular core prefabricated sleeve prepared in the step (1), and drawing and coating the fiber after the contraction rods are fused to obtain the medical optical fiber integrating the annular core and the optical fiber image transmission bundle.

(I) technical field

The invention relates to a medical optical fiber integrating an annular core and an image transmission bundle, and also relates to a preparation method of the optical fiber, belonging to the technical field of medical instruments.

(II) background of the invention

Currently, arterial cannulation techniques are well established. Under the guidance of clinical image medicine, the technology inserts special catheters, guide wires and other fine instruments to the diseased region for diagnostic imaging and treatment through a percutaneous blood vessel puncture way or the original pore canals of a human body. The technical method has simple operation and small damage, does not need to suture blood vessels, completely replaces the prior method of cutting and exposing blood vessels by operation, becomes the basic operation technology of modern interventional therapy, and has good effects on the aspects of blood supply embolism and medicine perfusion of tumors, intra-arterial irradiation, prevention of radioactive damage, chemotherapy and the like. However, because treatment is limited by the limitations of the treatment methods, there are few means by which light can be introduced into the interior of blood vessels. Therefore, for endovascular interventional therapy, an ideal medical device would include the following features: (1) the fine diameter is convenient for being inserted into the artery or vein vessel of the human body; (2) a channel for providing an illumination light source and transmission of treatment laser is provided, and illumination and treatment are provided for intravascular imaging; (3) the intravascular image acquisition and transmission device has intravascular image acquisition and image transmission functions.

The 201611234625.X patent proposes a vascular fiber-optic guidewire that can be introduced into an arterial vessel of a human body to introduce light into the diseased site in the vessel for photodynamic therapy. But its simple structure, the function is single, can't image to the intravascular. Chinese patent CN111552027A discloses an anderson local fiber surrounding a light wave channel, the fiber has a ring-shaped fiber core and anderson local fiber cores randomly distributed in the middle, the ring-shaped core of the fiber can be used as an illumination beam transmission channel, and the anderson local optical waveguide channel in the middle can be used as an image transmission channel. The chinese invention patent CN111603133A further provides an intravascular insertion type visual soft optical fiber surgical tool based on the optical fiber, the medical instrument can be easily inserted into a blood vessel, has an illumination beam transmission channel and an image transmission channel, and images the blood vessel by a demodulation method of deep learning, so as to conveniently and accurately find and locate a lesion region. Then, the laser irradiation ablation is carried out to treat the pathological change areas such as thrombus, tumor and the like in the blood vessel so as to meet the diagnosis and treatment requirements in the fields of biology, medical treatment and the like. However, the image transmission channel of the optical fiber is an Anderson local area waveguide, the image transmission pixel point of the waveguide is not enough, and a complex deep learning algorithm is needed to obtain a clear image, so that the optical fiber is relatively complex.

Disclosure of the invention

The invention aims to provide a medical optical fiber integrating an annular core and an image transmission bundle, relates to a preparation method and an application system of the optical fiber, can be used for imaging and operating pathological change areas such as tumors or thrombi in blood vessels, and has wide application in the treatment field of cardiovascular diseases.

The purpose of the invention is realized as follows:

the ring core and image transmission bundle integrated medical optical fiber 1 shown in fig. 1 comprises a ring core 1-1, a fluorine doped ring isolation layer 1-2, image transmission array fiber cores 1-3 densely arranged in the middle, quartz common cladding layers 1-4 and outermost silicon resin protective coating layers 1-5, and the inset is a partial enlarged view of an image transmission array fiber core unit.

The diameter of the medical optical fiber 1 is 400-500 microns, and the diameter of the coating layer 1-5 is 500-600 microns.

The overall diameter of the image transmission array fiber cores 1-3 densely arranged in the middle is 350-450 micrometers, and the number of the array fiber cores is 6000-10000.

The transmission image array fiber cores 1-3 densely distributed in the middle are densely distributed fiber cores distributed in a regular hexagon, the diameters of the adjacent fiber cores of each fiber core are different, and the outer layer of each fiber core is a fluorine-doped cladding and a quartz cladding.

The fluorine-doped annular isolation layer 1-2 is arranged in the middle of the annular core 1-1 and the intermediate image transmission array fiber core 1-3, and the three layers are coaxially distributed.

The preparation method of the medical optical fiber integrating the annular core and the image transmission bundle is specifically described as follows:

step 1: taking a thin-wall quartz tube 2-1, and sequentially depositing a germanium-doped annular core 2-2 and a fluorine-doped annular isolating layer 2-3 in the tube to form an annular prefabricated sleeve 2, wherein the transverse section and the refractive index distribution are shown in figure 2;

step 2: as shown in fig. 3, at least four thin-wall quartz tubes 3-1 are taken, fluorine-doped cladding layers 3-2 and germanium-doped fiber core layers 3-3 are sequentially deposited inside the thin-wall quartz tubes, and then the thin-wall quartz tubes are contracted at high temperature to form at least four image transmission fiber core prefabricated rods 3, wherein the outer diameter of each image transmission fiber core prefabricated rod is the same, but the diameters of the germanium-doped fiber cores are different;

and step 3: pulling the image transmission fiber core prefabricated rod prepared in the step 2 at high temperature to prepare an image transmission unit prefabricated component with the same outer diameter and different core diameter diameters, and cutting the prefabricated component into multiple sections with equal length;

and 4, step 4: as shown in fig. 4, a thin-wall quartz tube 4-1 is taken, the image transmission unit preforms (a-D) drawn in the step 3 are arranged in the tube according to regular hexagon close packing, the diameter of the fiber core of each image transmission unit preform is different from that of the adjacent preform components, and a filling quartz rod 4-2 with proper diameter is inserted into the gap between the regular hexagon and the quartz tube;

and 5: pumping the pile body obtained in the step (4) at high temperature to shrink the rod, forming a solid prefabricated rod, and then drawing at high temperature to form an image transmission unit array prefabricated part (4);

step 6: taking a thin-wall quartz tube, densely arranging the image transmission unit array prefabricated members 4 in the step 5 in the tube, shrinking the rod at high temperature, drawing the image transmission unit array prefabricated members with higher fiber core density again, and repeating the step until obtaining the array fiber core prefabricated members 5 with the number of the image transmission array fiber cores meeting the requirement and the outer diameter equal to the inner diameter of the annular prefabricated sleeve 2 in the step 1;

and 7: as shown in fig. 5, the array fiber core preform 5 obtained in step 6 is inserted into the ring core preform sleeve 2 prepared in step 1, and after the final preform 6 is obtained by collapsing and fusing, the fiber is drawn and coated, so as to obtain the medical optical fiber integrating the ring core and the optical fiber image transmission bundle.

Further, as shown in fig. 6, a medical application system of a medical optical fiber with an integrated ring core and an optical fiber image bundle is provided, which includes: the medical optical fiber 1, the illumination light source 7, the operation light source 8, the optical fiber wavelength division multiplexer 9, the optical fiber side throwing coupler 10 and the camera 11 that the ring core and the optical fiber image transmission bundle are integrated, in the system: (1) light waves 14 of the illumination light source 7 and the operation light source 8 are input into the annular core of the medical optical fiber for transmission after passing through the optical fiber wavelength division multiplexer 9 and the optical fiber side throwing coupler 10; (2) the illumination light beam transmitted in the annular core provides illumination in the blood vessel 12, the image transmission core array in the middle collects and transmits an image 16 in the blood vessel to the camera 11 for detection, and a lesion area 13 is searched; (3) the surgical beam transmitted within the annular core removes the diseased region within the blood vessel.

Optionally, as shown in fig. 7, the probe end of the medical optical fiber integrated with the annular core and the optical fiber image transmission bundle is provided with a ground frustum structure 17, so that the light beam 14 transmitted in the annular core can be focused.

As shown in fig. 8, the optical fiber side-polishing coupler 10 is formed by respectively side-polishing the single-mode optical fiber 15 and the medical optical fiber 1 with the ring-shaped core and the optical fiber image bundle integrated, and then attaching a side-polishing surface to couple the single-mode optical fiber 15 and the ring-shaped core.

Optionally, the illumination light source 7 is an incoherent broadband light source, and the image transmission core array transmits scattered light containing image information of intravascular tissue.

Optionally, the illumination light source 7 is a fluorescence excitation light source at the lesion tissue, the image transmission fiber core array transmits a fluorescence image, and an excitation light filter is installed in front of the camera 11.

Preferably, the operation light source 8 is a pulsed laser light source with strong absorption band of the lesion tissue.

The invention has the following significant advantages:

(1) the system can realize illumination and ablation operation in the blood vessel, achieves the purpose of concentrating all functions of illumination, imaging and operation in the same optical fiber, not only can perform imaging diagnosis on a diseased region in the blood vessel, but also can realize real-time monitoring while performing laser ablation operation, and ensures the operation quality.

(2) Because a plurality of functions are integrated in one optical fiber, the diameter of the whole optical fiber is fine, and the optical fiber is particularly suitable for diagnosis and treatment of fine intravascular diseases.

(3) The quantity of middle array fibre core is at 6000 ~ 10000 points, and pixel point quantity is many to adopt different fibre core diameters, restrained the crosstalk between every pixel passageway, the formation of image resolution is high.

(IV) description of the drawings

Fig. 1 is an end face structural view of a medical optical fiber 1 in which a ring core and an image transmission bundle are integrated, and an enlarged portion is a detailed view of a partial image transmission fiber core array.

Fig. 2 shows an annular prefabricated sleeve 2 and its refractive index profile.

Fig. 3 is an end view of the image transfer unit preform 3 and its refractive index profile.

FIG. 4 is a prefabricated member of an image transfer unit array arranged according to adjacent different specifications by four different prefabricated members of image transfer units.

Fig. 5 shows the final preform of the medical optical fiber with the ring-shaped core and the image transmission bundle integrated, and the preform is formed by arranging a plurality of image transmission unit array preforms into a ring-shaped prefabricated sleeve.

Fig. 6 is a diagram of an application system of the medical optical fiber integrating the annular core and the image transmission bundle.

Fig. 7 shows a cone frustum structure of the ground medical optical fiber end with the ring-shaped core and the image transmission beam integrated, which can make the ring-shaped beam in the ring-shaped core converge in front of the end surface.

FIG. 8 is a side-cast coupling schematic of a single-mode fiber coupling a light beam into a ring-core waveguide.

Fig. 9 is a schematic diagram of the operation of a medical fiber-optic probe with an integrated annular core and image transmission bundle in a blood vessel, wherein the system for intravascular thrombectomy according to the invention is described in embodiment 1. 12 denotes a blood vessel, 18-1 denotes an illumination region, 18-2 denotes an operation region, and 19 denotes a thrombus.

(V) detailed description of the preferred embodiments

The invention is further illustrated below with reference to specific examples.

Example 1: and (4) preparing the optical fiber.

Step 1: as shown in fig. 2, a thin-wall quartz tube 2-1 is taken, and a germanium-doped annular core 2-2 and a fluorine-doped annular isolation layer 2-3 are sequentially deposited in the tube to form an annular prefabricated sleeve 2, and the obtained sleeve and the refractive index distribution thereof are shown in fig. 2;

step 2: taking at least four thin-wall quartz tubes 3-1, sequentially depositing fluorine-doped cladding 3-2 and germanium-doped fiber core 3-3 layers inside the thin-wall quartz tubes, and then shrinking the rods to form at least four image-transmitting fiber core prefabricated rods 3, wherein the fluorine-doped cladding of each image-transmitting fiber core prefabricated rod has the same thickness, the germanium-doped fiber cores have different diameters, and the obtained image-transmitting fiber core prefabricated rods and the refractive index distribution thereof are shown in figure 3;

and step 3: pulling down the image transmission prefabricated rod 3 prepared in the step 2 at high temperature to prepare an image transmission unit prefabricated component with the same outer diameter and different core diameters, cutting the prefabricated component into multiple sections with equal length, and marking the end face of the prefabricated rod with each fiber core diameter by different colors;

and 4, step 4: taking a thin-wall quartz tube, and densely packing and arranging the image transmission unit prefabricated members drawn in the step 3 in the tube according to a regular hexagon arrangement structure, wherein each prefabricated member is different from the adjacent prefabricated members, and A-D respectively represent image transmission fiber core prefabricated rods with different fiber core diameters as shown in figure 4. Then, inserting a filling quartz rod 4-2 with a proper diameter into the gap between the regular hexagon and the quartz tube;

and 5: pumping the pile body obtained in the step (4) at high temperature to shrink the rod, forming a solid prefabricated rod, and then drawing at high temperature to form an image transmission unit array prefabricated part (4);

step 6: taking a thin-wall quartz tube, arranging the image transmission unit array prefabricated members in the step 5 in the tube in a dense mode, and similarly, inserting filling quartz rods with proper diameters into gaps between the regular hexagons and the quartz tube, as shown in FIG. 5. Then, the rod is contracted at high temperature, the image transmission unit array prefabricated part with higher fiber core density is drawn again, the step is repeated until an array fiber core prefabricated rod 5 with the number of the image transmission array fiber cores meeting the requirement and the outer diameter equal to the inner diameter of the first prefabricated sleeve in the step 1 is obtained;

and 7: and (3) inserting the array fiber core prefabricated rod obtained in the step (6) into the annular core prefabricated sleeve 2 prepared in the step (1), and drawing and coating after rod contraction fusion to obtain the annular core and optical fiber image transmission bundle integrated medical optical fiber 1 shown in the figure 1.

Example 1: the application case of the optical fiber, and intravascular thrombus ablation operation.

The present embodiment uses the ring-shaped core and the image transmission bundle integrated medical optical fiber as shown in fig. 1, and the whole system is shown in fig. 6. The system comprises an incoherent broadband illumination light source 7, a power-adjustable surgical laser light source 8, an optical fiber wavelength division multiplexer 9, an optical fiber side-throwing coupler 10, a medical optical fiber 1, and a camera 11.

Wherein the illumination light source 7 adopts an LED light source with the central wavelength of 460 nm; an infrared semiconductor laser with the wavelength of 810nm is selected as an operation laser light source, and the power is adjustable from 0W to 3W; the camera 11 adopts a CCD detector, and an infrared cut-off filter is arranged in front of the detector to prevent the operation laser from reaching the detector and influencing the imaging effect.

First, the optical fiber probe according to the present invention is inserted into an arterial blood vessel through a puncture needle (see fig. 9), and image information in the blood vessel needs to be obtained in order to find an accurate thrombus region. The illumination source 8 is turned on and the illumination beam provides illumination 14 to the interior of the vessel, with an illumination area of 18-1.

Then, scattered light of thrombus in the blood vessel is collected and transmitted by the fiber core array of the image transmission bundle of the optical fiber, and after the image signal light passes through the objective lens, the distribution of the image signal light is obtained on the CCD, so that an image in the blood vessel is obtained.

Finally, the position of the optical fiber probe in the blood vessel 12 is adjusted until the image acquisition system acquires the image of the area of the thrombus 19, the operation light source 9 is turned on, the power is adjusted, and the ablation operation is performed on the thrombus 19, wherein the operation area is 18-2.

And monitoring the thrombus removal state in the blood vessel through an image acquisition system until the thrombus is completely removed.

Example 3: intravascular thrombectomy based on fluorescence imaging.

This example differs from example 1 in that:

(1) in this embodiment, a certain amount of fluorescent marker needs to be injected into the blood vessel in advance, and the operation is performed after the diseased thrombus region specifically absorbs the fluorescent marker.

(2) The illumination light source adopted in this embodiment is a laser of fluorescence excitation band of the fluorescent marker. After the cells in the lesion area absorb the fluorescence labeling medicine, the fluorescence excitation lighting source is turned on, only the thrombus area with the lesion in the blood vessel can emit fluorescence, and the fluorescence signal is transmitted back to the imaging system through the image transmission beam fiber core array, so that an exact fluorescence image of the lesion area can be obtained. Then the thrombus is cleared by using the surgical light source.

In the description and drawings, there have been disclosed typical embodiments of the invention. The invention is not limited to these exemplary embodiments. Specific terms are used in a generic and descriptive sense only and not for purposes of limitation, the scope of the invention being set forth.