Laser catheter

Abstract

The invention belongs to the technical field of medical instruments, and discloses a laser catheter, which comprises a main body, a ring sleeve, an optical fiber bundle and a filler, and is characterized in that the ring sleeve is arranged at the far end of an outer tube and is communicated with the outer tube; the optical fiber bundle penetrates through the outer tube and the ring sleeve, the filler is filled between the ring sleeve and the optical fiber bundle, and the ball body is mixed in the filler. When the laser catheter provided by the invention is used for ablation, the sphere can reflect at least part of laser reflected to the far end face of the laser catheter by tissues, so that the absorption of the far end face of the laser catheter to laser energy is reduced, the risk of particle falling is reduced, the damage resistance is improved, the service life is prolonged, and the safety of an operation is improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, and in particular to a laser catheter. BACKGROUND

[0002] Laser ablation is a kind of auxiliary treatment technology for heart intervention, which is widely used in calcified occlusive lesions that cannot be passed by balloon, in-stent restenosis or poor expansion, complete occlusion (CTO) and venous bridge vascular lesions. Laser ablation technology mainly achieves therapeutic effect through photochemical effect, photothermal effect and photo-mechanical effect. For example, through photochemical effect, the molecular bonds of plaque are directly broken, and the calcified and fibrotic tissue is ablated into microparticles that can be metabolized and absorbed by the human body.

[0003] Laser ablation is usually implemented by using a laser catheter, that is, laser pulses are coupled into the optical fiber of the laser catheter, and the optical fiber guides the laser pulses to the lesion tissue in the blood vessel for ablation. In the process of ablation, part of the laser ablated lesion tissue is reflected to the distal end of the laser catheter, and the distal end of the laser catheter is damaged by absorbing excessive laser, for example, the distal end of the laser catheter falls off particles, affecting the safety of the operation, and the falling off of the particles also causes damage to the distal end of the optical fiber.

[0004] The existing laser catheter is suitable for high peak power and large energy ultraviolet laser, and the distal end will be damaged due to the reflection of the laser and the falling off of the particles, and the treatment effect on calcified lesions is limited. SUMMARY

[0005] The purpose of the present application is to provide a laser catheter suitable for high peak power and large energy ultraviolet laser, which improves the effectiveness and effectively improves the damage resistance.

[0006] To achieve this purpose, the present application adopts the following technical solutions:

[0007] A laser catheter is provided, comprising:

[0008] an outer tube;

[0009] a ring sleeve arranged at the distal end of the outer tube and in communication with the outer tube;

[0010] an optical fiber bundle arranged in the outer tube and the ring sleeve;

[0011] a filler filled between the ring sleeve and the optical fiber bundle, the filler mixed with spheres, the spheres capable of reflecting laser coming from the distal end of the laser catheter.

[0012] Optionally, the spheres account for 1 / 2 to 4 / 5 of the volume of the filler;

[0013] And / or, the optical fiber bundle comprises a plurality of optical fibers, and a radius of the ball is 6 / 10~7 / 10 of a radius of the optical fiber.

[0014] Optionally, the optical fiber bundle has a gap, and the filler is filled in the gap, and part of the gap is filled with the ball.

[0015] Optionally, the optical fiber bundle comprises at least two ring groups radially arranged along the ring sleeve, the ring group comprises a plurality of optical fibers arranged circumferentially along the ring sleeve, the gap comprises a first gap formed between the optical fiber of one of the two adjacent ring groups located at the outer side and the optical fiber of one of the two adjacent ring groups located at the inner side, and the first gap is filled with the ball.

[0016] Optionally, the filler and the optical fiber bundle form an ablation-resistant distal end at a distal end of the laser catheter, and the ablation-resistant distal end is arranged protruding from a distal end of the ring sleeve.

[0017] Optionally, the ablation-resistant distal end is provided with a chamfer surface, and an angle of the chamfer surface is 20°~25°.

[0018] Optionally, the filler extends to a distal end of the outer tube.

[0019] Optionally, a cross-sectional area of a proximal end of the ring sleeve is smaller than a cross-sectional area of a distal end of the ring sleeve.

[0020] And / or, the proximal end of the ring sleeve is provided with an inwardly curved flange.

[0021] And / or, the ring sleeve is provided with a boss.

[0022] And / or, a periphery of the ring sleeve is provided with a plurality of reinforcing holes.

[0023] Optionally, a material of the ring sleeve is a developing material.

[0024] And / or, a material of the ball is quartz, zirconia or ruby.

[0025] Optionally, the laser catheter further comprises an inner tube, the inner tube is sequentially arranged through the outer tube and the ring sleeve, the optical fiber bundle is located outside the inner tube, and the filler is filled between the ring sleeve, the optical fiber bundle and the inner tube.

[0026] Optionally, the outer tube comprises:

[0027] A first tube, the first tube is provided with a mandrel.

[0028] A second tube, the second tube is arranged at a distal end of the first tube, a passage is formed between an outer wall of the distal end of the first tube and an inner wall of the second tube, and the inner tube is sequentially arranged through the passage, the second tube and the ring sleeve.

[0029] Optionally, the proximal end of the optical fiber bundle protrudes from the proximal end of the outer tube, and the laser catheter further comprises a binding sleeve, which is sleeved on the proximal end of the optical fiber bundle.

[0030] Optionally, the proximal end of the binding sleeve is provided with an end cap.

[0031] Optionally, the laser catheter further comprises a fixing sleeve and a lens, the fixing sleeve is sleeved on the binding sleeve, and the lens is arranged at the proximal end of the fixing sleeve.

[0032] Optionally, the proximal end face of the binding sleeve is a plane or an inclined plane, and the proximal end face, the distal end face of the binding sleeve and the perforated hole wall sleeved on the optical fiber bundle are all subjected to grinding and polishing treatment.

[0033] Beneficial effects: the laser catheter provided by the application, when used for ablation of calcified, fibrotic and other tissues in blood vessels, the laser emitted by the distal end of the optical fiber bundle is reflected by the tissues to the distal end face of the laser catheter, and the sphere can reflect at least part of the laser reflected by the tissues to the distal end face of the laser catheter, which is beneficial to reduce the absorption of laser energy by the distal end face of the laser catheter, thereby reducing the risk of particle shedding on the distal end face of the laser catheter, improving the anti-damage ability, especially in the process of using high peak power and large energy ultraviolet laser, the anti-damage ability is more obvious, so the sphere can prolong the service life of the laser catheter and improve the safety of the operation. In addition, the sphere mixed in the filler can also strengthen the stiffness of the filler, which is beneficial to reduce the risk of deformation of the ring. BRIEF DESCRIPTION OF DRAWINGS

[0034] Figure 1 is a schematic view of a distal end structure of the laser catheter provided by the application from one perspective;

[0035] Figure 2 is a schematic view of the distal end structure of the laser catheter provided by the application without a ring;

[0036] Figure 3 is a schematic view of the distal end structure of the laser catheter provided by the application from another perspective;

[0037] Figure 4 is a schematic view of the distal end structure of the laser catheter provided by the application from still another perspective;

[0038] Figure 5 is a sectional view of one embodiment of the distal end structure of the laser catheter provided by the application;

[0039] Figure 6 is a sectional view of another embodiment of the distal end structure of the laser catheter provided by the application;

[0040] Figure 7 is a cross-sectional view of a collar with a flange according to the present invention;

[0041] Figure 8 is a cross-sectional view of a collar with a flange and a boss according to the present invention;

[0042] Figure 9 is a cross-sectional view of a collar with a boss according to the present invention;

[0043] Figure 10 is a cross-sectional view of a collar with a reinforced hole according to the present invention;

[0044] Figure 11 is a schematic view of a laser catheter at a first tube according to the present invention;

[0045] Figure 12 is a schematic view of a laser catheter distal end quick exchange interface according to the present invention;

[0046] Figure 13 is a schematic view of an inner tube during assembly according to the present invention;

[0047] Figure 14 is a schematic view of an inner tube during assembly according to the present invention;

[0048] Figure 15 is a schematic view of a laser catheter proximal end structure according to the present invention;

[0049] Figure 16 is a schematic view of a laser catheter proximal end structure according to the present invention;

[0050] Figure 17 is a schematic view of an optical fiber according to the present invention;

[0051] Figure 18 is a schematic view of a binding collar according to the present invention;

[0052] Figure 19 is a schematic view of a laser catheter at a proximal end housing according to the present invention;

[0053] Figure 20 is a schematic view of a laser catheter proximal end structure according to the present invention; Figure 19 is a magnified view of structure E in

[0054] Figure 21 is a schematic view of a laser catheter proximal end structure according to the present invention;

[0055] Figure 22 is a cross-sectional view of a laser catheter proximal end structure according to the present invention;

[0056] Figure 23is another proximal end structure of the laser catheter provided by the present application;

[0057] Figure 24 is a structure diagram of the laser catheter provided by the present application;

[0058] Figure 25 is an exploded view of the structure of the laser catheter at the handle provided by the present application.

[0059] In the figure:

[0060] 100, outer tube; 101, channel; 110, first tube; 111, mandrel; 120, second tube;

[0061] 200, collar; 210, flange; 220, boss; 230, reinforcing hole;

[0062] 300, optical fiber bundle; 301, gap; 3011, first gap; 3012, second gap; 302, light spot; 310, optical fiber; 3101, coating layer; 3102, core; 3103, cladding; 311, first optical fiber segment; 312, second optical fiber segment;

[0063] 410, filler; 411, ablation distal end; 4111, chamfered surface; 420, sphere;

[0064] 500, inner tube; 501, quick exchange interface; 510, flexible shaft; 520, heat shrink tube;

[0065] 600, tightening sleeve; 610, inner chamfer; 620, end cap;

[0066] 710, fixing sleeve; 720, lens;

[0067] 800, handle; 801, groove; 810, first housing; 811, distal end shell; 8111, positioning groove; 812, proximal end shell; 820, second housing; 831, pressing plate; 832, threaded element. DETAILED DESCRIPTION

[0068] The embodiments of the present application are described in detail below, examples of which are shown in the accompanying drawings, wherein the same or similar reference numerals represent the same or similar components or components having the same or similar functions throughout. The embodiments described below by referring to the accompanying drawings are exemplary and are intended to explain the present application, and cannot be understood as a limitation of the present application.

[0069] In the description of the present application, unless explicitly defined and limited otherwise, the terms "connected", "connected", "fixed" should be understood broadly, for example, it can be fixed connection, but also can be detachable connection, can be mechanical connection, but also can be electrical connection, can be directly connected, but also through the intermediate medium indirectly connected, can be two elements inside the communication or the interaction relationship between two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0070] In the description of the present application, unless explicitly defined and limited otherwise, the first feature is "on" or "under" the second feature can include the first feature and the second feature directly contact, but also can include the first feature and the second feature is not directly contact but through the contact between them and other features. Moreover, the first feature is "on", "above" and "above" the second feature includes the first feature is directly above and obliquely above the second feature, or just means that the first feature is higher than the second feature in horizontal height. The first feature is "under", "below" and "below" the second feature includes the first feature is directly below and obliquely below the second feature, or just means that the first feature is less than the second feature in horizontal height.

[0071] The technical scheme of the present application is further illustrated below by specific embodiments in conjunction with the drawings.

[0072] Referring to Figure 1 and Figure 2 It is shown that the present embodiment provides a laser catheter, which includes an outer tube 100, a ring sleeve 200, a fiber bundle 300 and a filler 410. Wherein, the ring sleeve 200 is arranged at the distal end of the outer tube 100 and communicates with the outer tube 100; the fiber bundle 300 is arranged in the outer tube 100 and the ring sleeve 200; the filler 410 is filled between the ring sleeve 200 and the fiber bundle 300, and the filler 410 is mixed with a sphere 420, and the sphere 420 can reflect the laser light emitted towards the distal end of the laser catheter. It can be understood that the fiber bundle 300 includes a plurality of optical fibers 310.

[0073] It can be understood that the distal end of the outer tube 100 refers to the end far away from the operator during the operation (or refers to the end first contacting / interfering with the biological tissue when used on the biological body). The proximal end of the outer tube 100 refers to the opposite end of the distal end. In addition, the proximal end and the distal end of other components in the present embodiment are defined the same as the proximal end and the distal end of the outer tube 100, and the present embodiment will not be described in more detail.

[0074] In the interventional surgery, when the laser catheter is used to ablate the calcified, fibrotic and other tissues in the blood vessel, the laser emitted by the distal end of the fiber bundle 300 will be partially reflected back to the distal end of the laser catheter while ablation of the tissue, and the sphere 420 can reflect at least part of the laser reflected by the tissue to the distal end of the laser catheter, which is beneficial to reduce the absorption of laser energy by the distal end of the laser catheter, thereby reducing the risk of particles falling off the distal end of the laser catheter and improving the anti-damage ability, especially in the process of using high peak power and large energy ultraviolet laser, the anti-damage ability is more obvious, so the sphere 420 can prolong the service life of the laser catheter and improve the safety of the operation. In addition, the mixing of the sphere 420 in the filler 410 can also strengthen the stiffness of the filler 410, which is beneficial to reduce the risk of deformation of the ring sleeve 200.

[0075] It can be understood that the particles falling off the distal end of the laser catheter include the particles falling off the filler 410, which may cause the ring sleeve 200 and the filler 410 to separate, in other words, the mixing of the sphere 420 in the filler 410 can reduce the risk of particles falling off the filler 410, and also be beneficial to reduce the risk of the ring sleeve 200 separating from the distal end of the laser catheter.

[0076] In some embodiments, the material of the ring sleeve 200 is set as a developing material, which can be understood as that the ring sleeve 200 has developing effect under X-ray, which is beneficial to intraoperative observation and operation.

[0077] Exemplarily, the material of the ring sleeve 200 includes but is not limited to platinum-iridium alloy, tantalum or titanium alloy.

[0078] In some embodiments, the filler 410 can be set as a cured glue, such as epoxy resin. In this embodiment, the glue and the sphere 420 can be mixed first, and then injected and cured between the ring sleeve 200 and the fiber bundle 300.

[0079] Exemplarily, the sphere 420 accounts for 1 / 2-4 / 5 of the volume of the filler 410. For example, the glue and the sphere 420 are mixed in a volume ratio of 1:2. Exemplarily, 2ml of glue and 4ml of sphere 420 can be mixed first, and then the mixed liquid filler 410 is defoamed by a vacuum glue mixing machine (not shown), and finally the liquid filler 410 is filled between the ring sleeve 200 and the fiber bundle 300. It can be understood that too much proportion of the sphere 420 may affect the filling quality, for example, there are voids 301 that are not filled, for example, the sphere 420 accounts for more than 4 / 5 of the volume of the filler 410; too little proportion of the sphere 420 will reduce the stiffness and the ability to reflect laser of the filler 410, for example, the sphere 420 accounts for less than 1 / 2 of the volume of the filler 410.

[0080] In some embodiments, the radius of the ball 420 is 6 / 10~7 / 10 of the radius of the optical fiber 310, which is conducive to improving the uniformity of the arrangement of the optical fiber 310 in the ring 200.

[0081] Exemplarily, the material of the ball 420 includes but is not limited to quartz, zirconia or ruby, which has a high reflectivity and hardness, is conducive to reducing the absorption of the laser energy by the distal end of the laser catheter, and can improve the rigidity of the filler 410.

[0082] It can be understood that after the laser is emitted from the distal end of the optical fiber 310, in the contrast agent and blood environment, an optical mechanical effect is formed, and sound waves are generated near the distal end of the filler 410 and bear the reaction force of the sound waves. In the present embodiment, the hardness of the ball 420 is higher than that of the cured glue, which is conducive to reducing the risk of damage of the filler 410 due to the optical mechanical effect and prolonging the service life.

[0083] In some embodiments, as shown in Figure 3 The optical fiber bundle 300 has a gap 301, the filler 410 is filled in the gap 301, and part of the gap 301 is filled with the ball 420, which is conducive to improving the uniformity of the arrangement of the optical fiber 310 in the ring 200.

[0084] In a feasible implementation, the optical fiber bundle 300 includes at least two ring groups arranged radially along the ring 200, the ring group includes a plurality of optical fibers 310 arranged circumferentially along the ring 200, and the gap 301 includes a first gap 3011 formed between the optical fiber 310 located on the outer side and the optical fiber 310 located on the inner side of the two adjacent ring groups. The first gap 3011 can be filled with the ball 420, which is conducive to improving the uniformity of the arrangement of the optical fiber 310 in the ring 200.

[0085] Exemplarily, the first gap 3011 is formed between the two adjacent optical fibers 310 located on the outer side and one or two adjacent optical fibers 310 located on the inner side of the two adjacent ring groups.

[0086] In a feasible implementation, the gap 301 further includes a second gap 3012 formed between the two adjacent optical fibers 310 of the same ring group, and the second gap 3012 can not be filled with the ball 420, which is conducive to improving the uniformity of the arrangement of the optical fiber 310 in the ring 200.

[0087] In some embodiments, as shown in Figure 4 and Figure 5 The filler 410 and the optical fiber bundle 300 form an ablation-resistant distal end 411 at the distal end of the laser catheter, and the ablation-resistant distal end 411 protrudes from the distal end of the ring 200 to facilitate grinding.

[0088] Exemplarily, the ablation distal end 411 is ground to form a substantially conical structure, and at least part of the sphere 420 after grinding forms a light-reflecting surface with a lower roughness, which is beneficial to improve the reflection performance of the laser and reduce the absorption of the laser energy by the distal end surface of the laser catheter. Moreover, grinding the distal end surface of the filler 410 can make the distal end of the filler 410 have a lower roughness, which is beneficial to reduce the risk of particle shedding on the filler 410 and improve the damage resistance.

[0089] In a feasible implementation, the ablation distal end 411 is provided with a chamfer surface 4111, and the angle a of the chamfer surface 4111 is set to 20°-25°, which has good passability and is beneficial to reduce the risk of scratching the inner wall of the blood vessel by the ablation distal end 411. In addition, the laser is refracted towards the axis direction of the laser catheter through the chamfer surface 4111, which improves the ablation capability of the calcified lesion.

[0090] Exemplarily, the distal end of the ring sleeve 200 is provided with a rounded surface, which is beneficial to reduce the risk of scratching the inner wall of the blood vessel by the ablation distal end 411. In some embodiments, as shown in Figure 4 , the chamfer surface 4111 and the rounded surface intersect and smoothly transition. In other embodiments, as shown in Figure 5 , the outer peripheral surface of the ablation distal end 411 and the outer peripheral surface of the ring sleeve 200 are arranged in the axial direction of the ring sleeve 200, for example, the outer peripheral shape of the ablation distal end 411 and the ring sleeve 200 is cylindrical; it can be understood that the shape of the ring sleeve 200 is annular.

[0091] Exemplarily, the ablation distal end 411 can be provided in a circular truncated cone shape.

[0092] In some embodiments, as shown in Figure 6 , the filler 410 extends to the distal end of the outer tube 100 to realize the fixed connection between the ring sleeve 200 and the outer tube 100, which is stable and reliable.

[0093] Exemplarily, the proximal end of the ring sleeve 200 abuts against the distal end of the outer tube 100, or the proximal end of the ring sleeve 200 is inserted into the outer tube 100.

[0094] In a feasible implementation, as shown in Figures 6 to 10 , the cross-sectional area of the proximal end of the ring sleeve 200 is smaller than the cross-sectional area of the distal end of the ring sleeve 200, which is beneficial to reduce the risk of the ring sleeve 200 being separated from the distal end of the filler 410.

[0095] Exemplarily, the ring sleeve 200 can be provided in a circular truncated cone annular shape.

[0096] In a feasible implementation, as shown in Figure 7 and Figure 8As shown, the proximal end of the collar 200 is provided with an inwardly curved flange 210 to reduce the cross-sectional area of the proximal end of the collar 200, which is conducive to reducing the risk of the collar 200 being detached from the distal end of the filler 410.

[0097] In an implementable embodiment, as shown in Figure 8 and Figure 9 , the collar 200 is provided with a boss 220, and a limit is formed between the boss 220 and the filler 410 in the axial direction of the collar 200, which is conducive to reducing the risk of the collar 200 being detached from the distal end of the filler 410.

[0098] Illustratively, the boss 220 can be formed by outward concave and inward convex of the peripheral portion of the collar 200.

[0099] Illustratively, the boss 220 can be annular in shape.

[0100] In an implementable embodiment, as shown in Figure 10 , the peripheral portion of the collar 200 is provided with a plurality of reinforcing holes 230, and the filler 410 can be filled into the reinforcing holes 230 to reinforce the connection between the filler 410 and the collar 200, which is conducive to reducing the risk of the collar 200 being detached from the distal end of the filler 410.

[0101] Illustratively, the reinforcing holes 230 are arranged in multiple rows along the circumferential direction of the collar 200, and each row is provided with a plurality of reinforcing holes.

[0102] In the present embodiment, for the distal end of the outer tube 100 with a diameter of less than 1 mm, the collar 200 as shown in Figure 5 may be selected, which is conducive to reducing the overall size; for the distal end of the outer tube 100 with a diameter of more than 1 mm, the collar 200 as shown in Figures 6 to 10 may be selected. Among them, for the distal end of the outer tube 100 with a diameter of between 1.5 mm and 2.5 mm, the collar 200 as shown in Figures 7 to 10 may be selected.

[0103] In some embodiments, as shown in Figure 1 , Figures 11 to 14 , the laser catheter further comprises an inner tube 500, the inner tube 500 is sequentially arranged in the outer tube 100 and the collar 200, the optical fiber bundle 300 is located outside the inner tube 500, and the filler 410 is filled between the collar 200, the optical fiber bundle 300 and the inner tube 500. In the present embodiment, the inner tube 500 can allow a guide wire (not shown) to pass through, and under the guidance of the guide wire, the laser catheter can reach the tissue to be ablated.

[0104] Illustratively, the material of the inner tube 500 can be Polytetrafluoroethylene (PTFE for short).

[0105] In one feasible implementation, such as Figure 11 As shown, the outer tube 100 includes a first tube 110, within which a mandrel 111 is disposed. In this embodiment, the mandrel 111 is made of materials including, but not limited to, stainless steel or a more flexible nickel-titanium alloy, providing good support and facilitating the delivery of the laser catheter within the blood vessel. Exemplarily, the mandrel 111 can be configured as a variable-diameter shaft, with the proximal diameter of the mandrel 111 being smaller than the distal diameter.

[0106] In one feasible implementation, such as Figure 12 As shown, the outer tube 100 also includes a second tube 120, which is sleeved on the distal end of the first tube 110. A channel 101 is formed between the outer wall of the distal end of the first tube 110 and the inner wall of the second tube 120. The inner tube 500 passes through the channel 101, the second tube 120 and the ring 200 in sequence. That is, the proximal end of the inner tube 500 is located outside the first tube 110, which helps to reduce the size of the first tube 110, improve the passability, facilitate the delivery of the outer tube 100 in the blood vessel, and has a simple and compact structure. The distal end of the inner tube 500 is located in the approximate central area of ​​the second tube 120 and the ring 200, which allows the guidewire to pass through without affecting the laser catheter ablation function.

[0107] For example, such as Figure 13 and Figure 14 As shown, when assembling the first tube 110, the second tube 120, and the inner tube 500, firstly, the distal end of the first tube 110 can be pre-formed to form a recess; secondly, the proximal end of the second tube 120 is fitted over the distal end of the first tube 110 to form a channel 101 in the recess; thirdly, the inner tube 500, through which the flexible shaft 510 passes, is inserted into the channel 101 through the recess, wherein a section of the proximal end of the inner tube 500 is left outside the channel 101, for example, 20mm to 30mm; fourthly, a heat-shrink tubing 520 is fitted over the junction of the first tube 110 and the second tube 120 and heated, causing the heat-shrink tubing 520 to shrink and weld itself to the reserved section of the first tube 110, the second tube 120, and the inner tube 500, so that the outer tube 100 has good airtightness. After welding, the heat-shrink tubing 520 can be removed, and the flexible shaft 510 can be pulled out. After applying a hydrophilic coating to the junction of the first tube 110 and the second tube 120, the reserved section of the inner tube 500 can be cut off to form the inner tube 500 as shown in the figure. Figure 12 The fast-switch interface 501 is shown. It is understood that the use of the flexible shaft 510 helps the inner tube 500 maintain its circular shape.

[0108] In some embodiments, such as Figures 15 to 20As shown, the proximal end of the fiber bundle 300 protrudes from the proximal end of the outer tube 100, and the laser catheter further comprises a bundling sleeve 600 sleeved on the proximal end of the fiber bundle 300. It can be understood that the bundling sleeve 600 has a perforation for sleeving the fiber bundle 300. In this embodiment, the laser emitted by the laser source forms a light spot 302 after homogenization coupling, and the proximal end of the fiber bundle 300 receives the light spot 302. In order to ensure the coupling efficiency of the system and the utilization rate of the laser, the light spot 302 is usually small, and the bundling sleeve 600 can gather the optical fibers 310 of the fiber bundle 300, which is conducive to preventing the proximal end of the fiber bundle 300 from being damaged due to the matching problem of the light spot 302 and the fiber bundle 300, and conducive to the import of the laser into the optical fibers 310, thereby improving the utilization rate of the laser.

[0109] Exemplarily, the length of the proximal end of the fiber bundle 300 protruding from the proximal end of the outer tube 100 is 5cm~10cm.

[0110] Exemplarily, the proximal end face of the fiber bundle 300 needs to be ground and polished, and after grinding, no scratches are observed under a 200 times microscope. In order to facilitate the grinding of the proximal end face of the fiber bundle 300, the proximal end face of the fiber bundle 300 protrudes from the proximal end of the bundling sleeve 600.

[0111] In a feasible implementation, the optical fiber 310 comprises a first optical fiber segment 311 and a second optical fiber segment 312 without a coating layer 3101, the first optical fiber segment 311 is sleeved in the outer tube 100 and the ring sleeve 200, and the bundling sleeve 600 is sleeved on the second optical fiber segment 312. It can be understood that the first optical fiber segment 311 comprises a coating layer 3101.

[0112] Exemplarily, the optical fiber 310 comprises, in sequence from the inside to the outside in the radial direction, a core 3102, a cladding 3103 and a coating layer 3101, the coating layer 3101 can be removed by ultrasonic cleaning, and after the proximal end face of the second optical fiber segment 312 is ground, no scratches are observed under a 200 times microscope, and the difference between single optical fibers 310 is less than 0.02mm, so as to improve the anti-damage ability of the proximal end face of the fiber bundle 300. It can be understood that the ground end face of the second optical fiber segment 312 (the proximal end face of the second optical fiber segment 312) is the laser incidence end, and high peak power and large energy ultraviolet laser can be incident on the ground end face of the second optical fiber segment 312.

[0113] Exemplarily, the material of the core 3102 can be high-hydroxyl quartz.

[0114] Exemplarily, the material of the cladding 3103 can be doped quartz.

[0115] Exemplarily, the material of the coating layer 3101 can be polyimide.

[0116] It can be understood that the laser is introduced into the optical fiber 310 from the proximal end face of the optical fiber bundle 300, and the proximal end face of the optical fiber bundle 300 needs to withstand high laser energy. The coating layer 3101 will be burned under the action of high-energy laser, and the residue after burning will affect the transmission of laser energy. Therefore, the coating layer 3101 of the second optical fiber segment 312 needs to be removed.

[0117] In a feasible implementation, the perforated distal end of the binding sleeve 600 is provided with an inner chamfer 610 to facilitate the passage of the optical fiber bundle 300. The two end faces of the binding sleeve 600 (i.e. the proximal end face and the distal end face of the binding sleeve 600) and the hole wall of the perforation are all polished. When the optical fiber bundle 300 passes through the perforation of the binding sleeve 600, the optical fiber bundle 300 can be pretreated by blowing filtered and dried plasma wind.

[0118] Exemplarily, the proximal end face of the binding sleeve 600 can be a flat surface or an inclined surface. The proximal end face of the binding sleeve 600 can be optionally treated by adding an anti-high-damage antireflection film or an anti-high-damage antireflection film.

[0119] Exemplarily, the material of the binding sleeve 600 includes but is not limited to ceramic, quartz, ruby, and metal, which has good high-temperature resistance and can withstand the scattered laser energy. In addition, it is beneficial to maintain the refractive index continuity of the core 3102 and the cladding 3103 of the optical fiber 310, and reduce the risk of light leakage during transmission.

[0120] It can be understood that, as shown in Figure 19 and Figure 20 , the area of the light spot 302 of the proximal end face of the optical fiber bundle 300 is larger than the cross-sectional area of the optical fiber bundle 300, so that the light spot 302 covers the entire end face of the optical fiber bundle 300, and then each optical fiber 310 has laser energy entering. Part of the laser transmitted towards the proximal end of the optical fiber bundle 300 will pass through the proximal end face of the binding sleeve 600, scatter in the binding sleeve 600, and the proximal end face of the binding sleeve 600 is polished. The polishing requirement is that there is no scratch under 200 times microscope and the edge is not damaged, especially to meet the needs of high peak power and large energy ultraviolet laser. It can reduce the risk of explosion of the binding sleeve 600 caused by laser irradiation, and then reduce the risk of damage to the optical fiber bundle 300 caused by the explosion of the binding sleeve 600. It can be understood that the proximal end face of the binding sleeve 600 is easy to be damaged by absorbing laser energy in the case of not being polished or having scratches.

[0121] In a feasible implementation, as shown in Figure 21 and Figure 22 , the proximal end of the binding sleeve 600 is provided with an end cap 620. The end cap 620 acts as a physical barrier to prevent external dust and moisture from directly contacting the proximal end face of the optical fiber bundle 300, and to prevent damage to the proximal end face of the optical fiber bundle 300, and to prevent light signal attenuation caused by pollution or damage.

[0122] Exemplarily, the outer end surface of the end cap 620 is spherical, having the effect of secondary light condensation, which is beneficial to reduce the area of the light spot 302 of the proximal end surface of the fiber bundle 300, and improve the transmission efficiency and coupling efficiency of the laser. At the same time of improving the coupling efficiency, a lower-power laser can be used, reducing the cost, and reducing the energy dissipated from the proximal end surface of the fiber bundle 300, and improving the anti-damage capability of the proximal end surface of the fiber bundle 300 when subjected to high peak power and large energy ultraviolet laser. The dissipated energy is the energy of the proximal end of the fiber bundle 300 that does not enter the fiber bundle 300. Of course, the outer end surface of the end cap 620 can also be planar. It can be understood that the smaller the diameter of the tight sleeve 600, the smaller the radius of curvature of the outer end surface of the end cap 620.

[0123] Exemplarily, the inner end surface of the end cap 620 is planar.

[0124] It can be understood that the outer end surface and the inner end surface of the end cap 620 need to be ground and polished to prevent bursting.

[0125] It can be understood that when the laser guide tube is applied to high peak power and large energy ultraviolet laser, the grinding of the proximal end of the fiber bundle 300 and the grinding of the tight sleeve 600 are both beneficial to reduce the risk of fiber 310 breakage.

[0126] In another possible implementation, as shown in Figure 23 The laser guide tube further includes a fixing sleeve 710 and a lens 720, the fixing sleeve 710 is sleeved on the tight sleeve 600, and the lens 720 is arranged at the proximal end of the fixing sleeve 710. The fixing sleeve 710 and the lens 720 can prevent external dust and moisture from directly contacting the proximal end surface of the fiber bundle 300, and can prevent the proximal end surface of the fiber bundle 300 from being damaged, and can prevent the light signal from being attenuated due to pollution or damage. The lens 720 has the effect of secondary light condensation, which is beneficial to reduce the area of the light spot 302 of the proximal end surface of the fiber bundle 300, and improve the transmission efficiency and coupling efficiency of the laser. It can be understood that improving the coupling efficiency of the laser means lower energy output of the laser, and the distal end of the laser guide tube can output higher energy. The cost of the laser is reduced. The arrow shown in Figure 23

[0127] Exemplarily, the material of the fixing sleeve 710 can be stainless steel.

[0128] Exemplarily, the material of the lens 720 can be ultraviolet quartz glass.

[0129] ​It can be understood that in the intervention surgery, different sizes of laser catheters are used for different inner diameters of blood vessels, and in order to reduce the structural complexity, a fixed value of laser injection is usually adopted, and the lens 720 and the end cap 620 with a spherical outer end face can be focused twice, thereby improving the coupling efficiency.

[0130] In some embodiments, as shown in Figure 19 、 Figure 20 、 Figure 24 and Figure 25 , the laser catheter further comprises a handle 800, and the proximal end of the outer tube 100 is inserted into the handle 800.

[0131] Generally, when the maximum output power of the laser source is constant, the shorter the time to reach the maximum output power, the higher the peak power. For spatial coupling of high peak power within 10 ns, the device requires stronger anti-damage capability. Generally, the numerical aperture of the fiber bundle 300 is 0.22. In order to ensure that all the optical fibers 310 in the fiber bundle 300 can be coupled into the laser, the size of the spot 302 should be larger than the size of the fiber bundle 300. The increase in the size of the spot 302 will cause a part of the spot 302 to leak to the surface of the handle 800. Due to the characteristics of high peak power, the surface of the handle 800 will be broken down to produce plasma or tiny particles. Under the action of continuous laser, the generated plasma or tiny particles will again absorb laser to cause micro-explosion, resulting in the fracture of the optical fibers 310 on the outside of the fiber bundle 300. Here, the unused laser on the outside of the fiber bundle 300 needs to be quickly attenuated in power to reduce the power density acting on the surface of the handle 800. Therefore, a scheme of adding a beam tightening sleeve 600 is proposed. The beam tightening sleeve 600 is a mirror that can quickly enlarge the spot 302 or reflect laser. The material of the mirror can be high-hydroxyl quartz material. In this way, the leaked laser on the outside of the fiber bundle 300 will first pass through the beam tightening sleeve 600. The part of the laser passing through the beam tightening sleeve 600 will change the size by refraction or change the path by reflection. The laser after changing the size or the path can reduce the laser energy per unit area, achieving the effect of high peak power coupling without damaging the fiber bundle 300.

[0132] In a feasible implementation, the handle 800 comprises a first housing 810 and a second housing 820. At least one of the first housing 810 and the second housing 820 is provided with a groove 801 for accommodating the proximal end of the outer tube 100, the proximal end of the fiber bundle 300 and the beam tightening sleeve 600 to realize positioning. It can be understood that the proximal end of the outer tube 100, the proximal end of the fiber bundle 300 and the beam tightening sleeve 600 are clamped between the first housing 810 and the second housing 820.

[0133] Exemplarily, the first shell 810 comprises a distal shell 811 and a proximal shell 812, the distal shell 811 is provided with a positioning slot 8111, the proximal shell 812 is inserted into the positioning slot 8111, and the proximal shell 812 is clamped between the distal shell 811 and the second shell 820. Exemplarily, the distal shell 811 is provided with a recess 801, or the distal shell 811 and the proximal shell 812 are both provided with the recess 801. In the embodiment, the second shell 820 can also be provided with the positioning slot 8111.

[0134] In an optional embodiment, the handle 800 further comprises a pressing plate 831, the pressing plate 831 is fastened to the proximal shell 812 through a screw 832, and the pressing plate 831 presses the binding sleeve 600 on the proximal shell 812, so that the connection is stable and reliable. Exemplarily, the screw 832 is provided with two, and the binding sleeve 600 is located between the two screws 832.

[0135] Exemplarily, the material of the distal shell 811 can be plastic material, so as to reduce the weight of the handle 800.

[0136] Exemplarily, the material of the proximal shell 812 can be medical stainless steel or aluminum alloy, so as to improve the positioning accuracy and the connection stability of the proximal end of the tube body, the proximal end of the optical fiber bundle 300 and the binding sleeve 600.

[0137] Exemplarily, the material of the second shell 820 can be plastic material, so as to reduce the weight of the handle 800.

[0138] Obviously, the above embodiments of the present application are only examples for clearly illustrating the present application, and are not intended to limit the embodiments of the present application. For those skilled in the art, various obvious changes, re-adjustments and replacements can be made without departing from the protection scope of the present application. Here, it is unnecessary and impossible to enumerate all the embodiments. Any modification, equivalent replacement and improvement made within the spirit and principle of the present application shall be included in the protection scope of the claims of the present application.

Claims

1. A laser catheter, characterized by, The laser catheter comprises: an outer tube (100); a ring sleeve (200) arranged at the distal end of the outer tube (100) and in communication with the outer tube (100); a fiber bundle (300) arranged in the outer tube (100) and the ring sleeve (200); a filler (410) filled between the ring sleeve (200) and the fiber bundle (300), wherein the filler (410) is mixed with spheres (420), and the spheres (420) can reflect laser light emitted towards the distal end of the laser catheter.

2. The laser catheter of claim 1, wherein, The spheres (420) account for 1 / 2-4 / 5 of the volume of the filler (410). The fiber bundle (300) comprises a plurality of optical fibers (310), and the radius of the spheres (420) is 6 / 10-7 / 10 of the radius of the optical fibers (310).

3. The laser catheter of claim 1, wherein, The fiber bundle (300) has a gap (301), the filler (410) is filled in the gap (301), and part of the gap (301) is filled with the spheres (420).

4. The laser catheter of claim 3, wherein, The fiber bundle (300) comprises at least two ring groups arranged radially along the ring sleeve (200), each ring group comprises a plurality of optical fibers (310) arranged circumferentially along the ring sleeve (200), the gap (301) comprises a first gap (3011) formed between the optical fiber (310) on the outer side and the optical fiber (310) on the inner side of two adjacent ring groups, and the first gap (3011) is filled with the spheres (420).

5. The laser catheter of claim 1, wherein, The filler (410) and the fiber bundle (300) form an ablation distal end (411) at the distal end of the laser catheter, and the ablation distal end (411) protrudes from the distal end of the ring sleeve (200).

6. The laser catheter of claim 5, wherein, The ablation distal end (411) is provided with a chamfer surface (4111), and the angle of the chamfer surface (4111) is 20°-25°.

7. The laser catheter of claim 1, wherein, The filler (410) extends to the distal end of the outer tube (100).

8. The laser catheter of claim 1, wherein, The cross-sectional area of the proximal end of the ring sleeve (200) is smaller than the cross-sectional area of the distal end of the ring sleeve (200). The proximal end of the ring sleeve (200) is provided with an inwardly curved flange (210). The ring sleeve (200) is provided with a boss (220). The ring sleeve (200) is provided with a plurality of reinforcing holes (230).

9. The laser catheter of claim 1, wherein, The material of the ring sleeve (200) is a radiopaque material. The material of the spheres (420) is quartz, zirconia or ruby.

10. The laser catheter of any of claims 1-9, wherein, The laser catheter further comprises an inner tube (500) arranged in the outer tube (100) and the ring sleeve (200) in sequence, the fiber bundle (300) is located outside the inner tube (500), and the filler (410) is filled between the ring sleeve (200), the fiber bundle (300) and the inner tube (500).

11. The laser catheter of claim 10, wherein, The outer tube (100) comprises: a first tube (110) provided with a mandrel (111) therein. A second tube (120) is sleeved on the distal end of the first tube (110), a channel (101) is formed between the outer wall of the distal end of the first tube (110) and the inner wall of the second tube (120), and the inner tube (500) is sequentially arranged in the channel (101), the second tube (120) and the ring sleeve (200).

12. The laser catheter of any of claims 1-9, wherein, The proximal end of the optical fiber bundle (300) protrudes from the proximal end of the outer tube (100), and the laser catheter further comprises a tightening sleeve (600) sleeved on the proximal end of the optical fiber bundle (300).

13. The laser catheter of claim 12, wherein, The proximal end of the tightening sleeve (600) is provided with an end cap (620). Alternatively, the laser catheter further comprises a fixing sleeve (710) and a lens (720), the fixing sleeve (710) is sleeved on the tightening sleeve (600), and the lens (720) is arranged at the proximal end of the fixing sleeve (710).

14. The laser catheter of claim 12, wherein, The proximal end surface of the tightening sleeve (600) is a plane or an inclined plane, and the proximal end surface, the distal end surface of the tightening sleeve (600) and the perforated hole wall sleeved on the optical fiber bundle (300) are all subjected to grinding and polishing treatment.

Images