Laser ablation catheter, laser ablation system, and regulation method for laser ablation system

Abstract

The present invention relates to the technical field of medical instruments and regulation methods therefor. Disclosed are a laser ablation catheter, a laser ablation system, and a regulation method for the laser ablation system. The laser ablation catheter comprises a tubular structure and an optical fiber bundle. The tubular structure is provided with an optical fiber channel. The optical fiber bundle is accommodated in the optical fiber channel. The optical fiber bundle is provided with an output end, and the output end is located at the far end of the tubular structure. The laser ablation system comprises the described laser ablation catheter. The present invention further provides a regulation method for a renal artery laser ablation system for regulating the described laser ablation system. The laser ablation catheter, the laser ablation system, and the regulation method for the laser ablation system provided by the present invention have good application effects.

Description

Laser ablation catheter, laser ablation system and method of regulating laser ablation system TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices and methods of regulating the same, and in particular to a laser ablation catheter, a laser ablation system and a method of regulating the laser ablation system. BACKGROUND

[0002] Due to factors such as population aging and unhealthy lifestyle, the prevalence of hypertension is on the rise, and it is estimated that the total number of patients with hypertension in China will reach more than 250 million, and the control rate of adult hypertension is about 15%.

[0003] The treatment methods for hypertension include drug therapy, lifestyle intervention and interventional therapy. Drug therapy is difficult to treat refractory hypertension, and patients generally have poor compliance with drug therapy. Renal denervation (RDN) is the most widely studied and has the most sufficient clinical evidence of interventional therapy for hypertension. The purpose is to block the signal transmission between the brain and the sympathetic nerve, reduce the overactive sympathetic nerve of the patient with hypertension, so as to play a role in reducing blood pressure. At present, RDN mainly uses radiofrequency energy, ultrasonic energy, cryogenic energy and chemicals to irradiate or inject the sympathetic nerve fibers located on the adventitia of the renal artery, so as to produce a certain effect on the sympathetic nerve fibers, such as a certain degree of damage, thereby causing the decrease of the whole body sympathetic nerve excitement level, and further causing the decrease of arterial blood pressure. There are mainly three categories: renal artery radiofrequency ablation, renal artery ultrasonic ablation and renal artery chemical drug local injection ablation, and there are fewer laser energy irradiation of sympathetic nerves. SUMMARY

[0004] The purpose of the present application is to provide a laser ablation catheter, a laser ablation system and a method of regulating the laser ablation system, which has good application effect.

[0005] To achieve the above-mentioned purpose, the technical solution provided by the present application is as follows: a laser ablation catheter, comprising: a tube structure and an optical fiber bundle, the tube structure has an optical fiber channel, the optical fiber bundle is accommodated in the optical fiber channel, the optical fiber bundle has an output end, and the output end is located at the distal end of the tube structure.

[0006] As one of the embodiments, the laser ablation catheter is a renal artery laser ablation catheter, the optical fiber bundle includes a plurality of first optical fibers with a core diameter less than 200 um, the first optical fibers are used to transmit first laser for irradiating sympathetic nerves, and the first optical fibers are arranged in the extension direction of the optical fiber channel.

[0007] Optionally, the bending radius of the first optical fiber is less than 10 mm; and / or, the first optical fiber is a multi-mode optical fiber.

[0008] Optionally, the laser ablation catheter is provided with a temperature sensing device for acquiring temperature of the target site.

[0009] Optionally, the temperature sensing device comprises a second optical fiber for transmitting second laser with a center reflection wavelength for temperature sensing of the target site, the second optical fiber is disposed in the plurality of first optical fibers and is simultaneously accommodated in the optical fiber channel with the first optical fibers.

[0010] Alternatively, the temperature sensing device is a resistance temperature device or a thermocouple.

[0011] Optionally, the bending radius of the second optical fiber is greater than or equal to 10 mm and less than or equal to 25 mm; and / or, the core diameter of the second optical fiber is greater than or equal to 8 um and less than or equal to 12 um.

[0012] Optionally, the output end of the optical fiber bundle is provided with a structure for releasing laser energy in a set direction.

[0013] Alternatively, the output end of the optical fiber bundle is provided with a structure for releasing laser energy in a circumferential direction.

[0014] Optionally, the tube structure comprises an inner tube and an outer tube.

[0015] The outer tube is sleeved on the periphery of the inner tube and is eccentrically arranged with the inner tube to form a first optical fiber placement channel, and the first optical fiber is arranged in the first optical fiber placement channel; the inner tube has a second optical fiber placement channel, and the second optical fiber is arranged in the second optical fiber placement channel.

[0016] The optical fiber channel comprises the first optical fiber placement channel and the second optical fiber placement channel.

[0017] As another embodiment, the tube structure is an elongated tube structure comprising an inner tube and an outer tube; the outer tube is sleeved on the periphery of the inner tube and is eccentrically arranged with the inner tube to form a first optical fiber placement channel, and the inner tube is used for passing a guide wire.

[0018] The output end of the optical fiber bundle is located at the distal end of the tube structure and has an inclined surface at an angle with the elongated axis of the tube structure.

[0019] The optical fiber bundle comprises a plurality of first optical fibers, the core diameter of the first optical fibers is smaller than the core diameter of the optical fiber bundle; and the plurality of first optical fibers are arranged in the first optical fiber placement channel.

[0020] Optionally, the laser ablation catheter further comprises a rotating member connected to the proximal end of the tube structure for driving the tube structure and the optical fiber bundle to rotate around the axial direction of the laser ablation catheter in a preset manner, so that the output laser of the optical fiber bundle can irradiate the ablation site at an angle of 360°.

[0021] Optionally, the rotating member is connected to the proximal end of the tube structure for driving the tube structure and the optical fiber bundle to rotate around the axial direction of the laser ablation catheter in a preset manner, so that the output laser of the optical fiber bundle can irradiate the ablation site at an angle of 360°, specifically comprising:

[0022] The rotating member is a luer adapter,

[0023] The preset manner is to emit laser for 10 seconds or 15 seconds every 45 degrees or 90 degrees.

[0024] Optionally, the laser ablation catheter further comprises a balloon assembly, which is sealingly sleeved to the distal end of the tube structure along the extension direction of the catheter, so that the inclined surface is arranged in the balloon assembly.

[0025] Optionally, the balloon assembly comprises a first balloon and / or a second balloon.

[0026] The first balloon and / or the second balloon are both sealingly sleeved to the distal end of the tube structure, and the second balloon is sleeved on the periphery of the first balloon.

[0027] Optionally, the output end of the optical fiber bundle is an inclined surface, which is arranged at an angle with the central axis of the laser ablation catheter, and the angle is greater than or equal to 20° and less than or equal to 40°.

[0028] Alternatively, the output end of the optical fiber bundle is a conical tip or a conical groove, and the taper angle of the conical tip or the conical groove is greater than or equal to 30° and less than or equal to 80°, or the output end of the optical fiber bundle is a circular truncated cone tip.

[0029] Optionally, the optical fiber bundle further comprises a second optical fiber, which is located in the first optical fiber arrangement channel and shares the input end of the optical fiber bundle and the output end of the optical fiber bundle with the first optical fiber, or the second optical fiber is arranged in the inner layer tube; the second optical fiber is used to sense the temperature of the distal end of the optical fiber bundle at the ablation site, or the laser ablation catheter is provided with a temperature sensing member for acquiring the temperature of the target site.

[0030] Optionally, the bending radius of the first optical fiber is less than 10 mm; and / or the core diameter of the first optical fiber is less than 200 um.

[0031] Optionally, the second optical fiber has a bending radius greater than or equal to 10 mm and less than or equal to 25 mm; and / or, the second optical fiber has a core diameter greater than or equal to 8 um and less than or equal to 12 um.

[0032] Optionally, the catheter seat is connected with a proximal end of the tube structure, and the catheter seat is provided with a liquid injection port for injecting liquid into the balloon assembly.

[0033] The application also provides a laser ablation system, comprising the laser ablation catheter.

[0034] Optionally, the control system is used to control the laser ablation catheter to output laser with a wavelength of 1064 nm.

[0035] The application also provides a laser ablation system, comprising a tube structure and an optical fiber bundle, the tube structure has an optical fiber channel, the optical fiber bundle is accommodated in the optical fiber channel, the optical fiber bundle comprises a first optical fiber and a second optical fiber, the first optical fiber is used to deliver a first laser and release the first laser at a sympathetic nerve of a target site, and the second optical fiber is used to deliver a second laser for temperature sensing of the target site and generating a center reflection wavelength.

[0036] A control unit is connected with at least the optical path of the laser ablation catheter, and is used to perform the following steps:

[0037] The first laser is emitted to the first optical fiber, and the first laser is used to irradiate the target site.

[0038] After the second laser is emitted to the second optical fiber, the center reflection wavelength from the second optical fiber is received, and the temperature of the target site is obtained according to the center reflection wavelength.

[0039] The emission energy of the first laser in the next time is determined according to the temperature of the target site.

[0040] Optionally, the center reflection wavelength from the second optical fiber is received, and the temperature of the target site is obtained according to the center reflection wavelength, specifically including that the center reflection wavelength and the temperature of the target site have a mapping relationship.

[0041] The application also provides a regulation method of a (renal artery) laser ablation system, which is used to regulate the laser ablation system, and comprises the following steps:

[0042] The first laser and the second laser are emitted, the first laser is used to irradiate the sympathetic nerve of the target site, and the second laser is used to trigger the temperature sensing of the target site.

[0043] The temperature of the target site is obtained.

[0044] determining the emission energy of the first laser next time according to the temperature of the target site.

[0045] Optionally, the step of determining the emission energy of the first laser next time according to the temperature of the target site comprises the following steps:

[0046] The first laser is continuous laser, and when the acquired temperature of the target site is less than or equal to a preset maximum temperature value and greater than or equal to a preset minimum temperature value, the output power of the first laser next time is stopped from being adjusted.

[0047] When the acquired temperature of the target site is greater than the preset maximum temperature value, the output power of the first laser next time is reduced.

[0048] When the acquired temperature of the target site is less than the preset minimum temperature value, the output power of the first laser next time is increased.

[0049] Alternatively, the first laser is pulse laser, and when the acquired temperature of the target site is less than or equal to a preset maximum temperature value and greater than or equal to a preset minimum temperature value, the output power or frequency of the first laser next time is stopped from being adjusted.

[0050] When the acquired temperature of the target site is greater than the preset maximum temperature value, the output power or frequency of the first laser next time is reduced.

[0051] When the acquired temperature of the target site is less than the preset minimum temperature value, the output power or frequency of the first laser next time is increased.

[0052] Optionally, the preset maximum temperature value is 60℃, and the preset minimum temperature value is 55℃.

[0053] Optionally, the step of emitting the first laser comprises the following steps:

[0054] The wavelength of the first laser is between 1034nm and 1094nm.

[0055] The laser ablation catheter and the laser ablation system have the following advantages: the core diameter of the first optical fiber is less than 200 um, the core diameter of the single first optical fiber is small, and the bending radius is correspondingly reduced; the smaller the bending radius, the greater the flexibility of the optical fiber; thus, the first optical fiber has better flexibility, so that the renal artery laser ablation catheter can easily enter the left and right renal arteries with a large-angle bend relative to the aorta, and freely move in the renal artery, with low power loss and high light transmission efficiency; compared with a large-core optical fiber, the first optical fiber is more suitable for application in the renal artery laser ablation catheter; in addition, the core diameter of the single first optical fiber is small, so that a plurality of first optical fibers can be arranged in the optical fiber bundle to ensure the size of the laser energy released by the optical fiber bundle, and the application effect is good.

[0056] Alternatively, the output end of the optical fiber bundle is located at the distal end of the tube structure and has an inclined surface at an angle to the elongated axis of the tube structure; the inclined surface is arranged at the distal end of the optical fiber bundle, and the distal end of the optical fiber bundle releases laser energy, so that the optical fiber bundle releases laser energy in one direction, i.e., releases laser energy toward the target area to be irradiated by laser, and the directionality of the released laser energy is stronger; the laser energy of the optical fiber bundle is concentrated in the target area, greatly increasing the intensity of the laser energy irradiated to the target area, avoiding the occurrence of insufficient laser irradiation energy, and the application effect is good.

[0057] The control method of the laser ablation system has the following advantages: the second laser for triggering the temperature of the target part is emitted, or a temperature sensing device is arranged, so that the temperature of the target part of the renal artery can be obtained in real time; the emission energy (output power) or / and frequency of the first laser in the next time is determined according to the temperature of the target part, so that the temperature feedback mechanism can be established by judging whether the current temperature of the target part of the renal artery meets the preset temperature, which helps to adjust the energy or / and frequency of the emitted first laser, so that the temperature of the target part of the renal artery is neither too high nor too low, and the reliability of the laser energy irradiation (acting on) the sympathetic nerve is greatly improved. BRIEF DESCRIPTION OF DRAWINGS

[0058] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiments or the prior art description. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative labor based on the drawings shown.

[0059] Fig. 1 is a front view of a first laser ablation catheter according to an embodiment of the present application;

[0060] Fig. 2 is a structural schematic view of the distal end of the laser ablation catheter in Fig. 1;

[0061] Fig. 3 is a left view of the laser ablation catheter of Fig. 1;

[0062] Fig. 4 is a front view of a first laser ablation catheter according to an embodiment of the present application;

[0063] Fig. 5 is a front view of a third laser ablation catheter according to an embodiment of the present application;

[0064] Fig. 6 is a schematic view of a laser ablation catheter according to an embodiment of the present application;

[0065] Fig. 7 is a schematic view of the laser ablation catheter of Fig. 6 without a catheter hub;

[0066] Fig. 8 is a schematic view of a distal end of the laser ablation catheter of Fig. 7;

[0067] Fig. 9 is a schematic view of another distal end of the laser ablation catheter of Fig. 7;

[0068] Fig. 10 is a schematic view of yet another distal end of the laser ablation catheter of Fig. 7;

[0069] Fig. 11 is a schematic view of a proximal end of the laser ablation catheter of Fig. 7;

[0070] Fig. 12 is a schematic view of a laser ablation system according to an embodiment of the present application;

[0071] Fig. 13 is a schematic view of an anatomical structure of a kidney according to an embodiment of the present application. DETAILED DESCRIPTION

[0072] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments of the present application, all other embodiments obtained by a person of ordinary skill in the art without creative work fall within the protection scope of the present application.

[0073] It should be noted that all directional indications (such as up, down, left, right, front, back, etc.) in the embodiments of the present application are only used to explain the relative positional relationship, movement condition, etc. between components in a certain posture, and if the certain posture changes, the directional indications also change accordingly.

[0074] In the technical field of medical devices, the position close to the operator is defined as proximal end, the position away from the operator is defined as distal end, the radial direction refers to the direction along the diameter or radius, the axial direction refers to the direction along the central axis, the radial direction and the axial direction are perpendicular to each other, and the circumferential direction refers to the circumferential direction around the central axis. Unless otherwise defined, all technical and scientific terms used in the present application have the same meanings as commonly understood by those skilled in the art to which the present application belongs. The common terms used in the specification of the present application are only for the purpose of describing the specific embodiments and cannot be understood as limiting the present application.

[0075] It should also be noted that when an element is referred to as being "fixed" or "disposed" on another element, it can be directly on the other element or can have a middle element. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or can have a middle element.

[0076] In addition, the descriptions involving "first", "second", etc. in the present application are only for the purpose of description and cannot be understood as indicating or implying the relative importance of the indicated technical features or implicitly indicating the number of the indicated technical features. Therefore, the features defined with "first", "second" can explicitly or implicitly include at least one of the features. In addition, the technical solutions of various embodiments can be combined with each other, but it must be based on the fact that a person skilled in the art can realize it, and when the combination of technical solutions appears contradictory or unachievable, it should be considered that the combination of technical solutions does not exist and is not within the protection scope required by the present application.

[0077] Embodiment one:

[0078] As shown in FIG. 1 and FIG. 2, the laser ablation catheter 100 provided by the embodiment of the present application includes an optical fiber bundle 10 and a tube structure 20; the tube structure 20 has an optical fiber channel 21; the optical fiber bundle 10 includes a plurality of first optical fibers 11 with a core diameter less than 200 um, the first optical fibers 11 are used to transmit first laser for irradiating sympathetic nerves, and the first optical fibers 11 are arranged in the extension direction of the optical fiber channel 21. In specific applications, the receiving end (i.e. proximal end) of the first optical fiber 11 receives the first laser, and after being transmitted to the output end (i.e. distal end), it is released towards the sympathetic nerve fibers on the adventitia of the renal artery, thereby realizing the irradiation of the sympathetic nerve fibers and adjusting or treating the sympathetic nerve fibers. Wherein, the first laser can be transmitted in continuous or pulse form.

[0079] In the present application, the fiber bundle 10 includes a plurality of first optical fibers 11 with a core diameter less than 200 um. In the process of bundling the plurality of first optical fibers 11 with a core diameter less than 200 um into the fiber bundle 10, it is difficult to arrange the plurality of small-core-diameter optical fibers closely and accurately together. The diameter of the optical fiber is very small, usually in the order of microns, and high-precision equipment and operation are required to ensure the positional accuracy of the optical fibers. If the optical fibers are not arranged neatly or there are gaps, it will affect the efficiency and quality of the bundling, for example, it may cause scattering or leakage of light during the bundling process, reducing the final output power and beam quality. Not only the optical fibers need to be arranged, but also the core of each optical fiber needs to be accurately aligned so that the light can be smoothly transmitted from the plurality of optical fibers to the bundled optical fiber. This requires high precision and stability of the equipment, because even a small deviation can cause loss of light transmission or reduction of coupling efficiency.

[0080] The process of fiber bundling needs to maintain a high degree of consistency to ensure stable performance of the bundled optical fiber. However, since the bundling process of small-core-diameter optical fibers is very sensitive to changes in process parameters, it is difficult to achieve consistency in the process, and strict control and monitoring of the process are required.

[0081] By adopting the technical scheme, the pipe structure 20 is provided, the pipe structure 20 has the optical fiber channel 21, the fiber bundle 10 is accommodated in the optical fiber channel 21, the pipe structure 20 plays a protective and binding role on the fiber bundle 10, avoids damage of the fiber bundle 10 by external objects, and improves the aggregation of the fiber bundle 10; the first optical fiber 11 is provided, the first optical fiber 11 can transmit the first laser, so that the renal artery laser ablation catheter 100 can damage the sympathetic nerve fibers located on the adventitia of the renal artery to a certain extent by using laser energy to realize the RDN technique; the core diameter of the first optical fiber 11 is set to be less than 200 um, the core diameter of the single first optical fiber 11 is small, and the bending radius is correspondingly reduced. The smaller the bending radius, the greater the flexibility of the optical fiber. In this way, the first optical fiber 11 has better flexibility, so that the renal artery laser ablation catheter 100 can easily enter the left and right renal arteries with a large angle bend with the aorta, and freely move in the renal artery, with low power loss and high light transmission efficiency. Compared with the large-core-diameter optical fiber, the first optical fiber 11 is more suitable for application in the renal artery laser ablation catheter 100. In addition, since the core diameter of the single first optical fiber 11 is small, the fiber bundle 10 can be provided with a plurality of first optical fibers 11 to ensure the laser energy released by the fiber bundle 10.

[0082] As shown in FIG. 13, the figure shows the main blood supply of the kidney, including the renal artery 902 (Main Renal Artery), and the internal branches of the kidney, such as the posterior branch 903 (Posterior Division) and the anterior branch 904 (Anterior Division). The figure also shows the connection of the kidney with the aorta 901 (Aorta) and the ureter 905 (Ureter). The angle between the renal artery 902 and the aorta 901 varies greatly from individual to individual, from acute angle to nearly right angle. This requires the optical fiber delivery system to have high adaptability in design, which can smoothly enter the renal artery 902 at different angles. The minimum turning radius of the traditional single fiber system is large, which may be difficult to accurately respond to such a wide range of angles, resulting in positioning deviation or failure to reach the target position during delivery.

[0083] At the same time, there are some small blood vessel branches around the starting part of the renal artery 902, which are distributed in the angle area between the renal artery and the aorta. When the delivery system passes through this area, it needs to avoid damage to these branches, otherwise it may cause serious complications. At the same time, the existence of these branches also increases the difficulty of the delivery system to accurately pass through the angle and position, requiring precise maneuverability and good tracking.

[0084] Based on the complexity of the above structure, the ductility of the catheter is very high. However, at the same time, ensuring sufficient pushing force is another key problem. Since the renal artery 902 is located deep, it needs to pass through a long blood vessel path from the femoral artery or radial artery to the renal artery 902, which puts high requirements on the transmission of pushing force. The design of the pipe material, guide wire and other components of the delivery system must be able to effectively transmit the pushing force from the outside to the renal artery site, while preventing energy loss during the pushing process, which causes the stent to fail to reach the predetermined position.

[0085] Therefore, in the design of the catheter, a balance point needs to be found in the material selection and structural design, which not only ensures that the delivery system can flexibly bend in the blood vessel, but also maintains a certain supporting force or pushing force.

[0086] In this application, a plurality of first optical fibers 11 with a core diameter less than 200 um are used to form a fiber bundle. During the process of bundling a plurality of first optical fibers 11 with a core diameter less than 200 um, multiple process treatments are required. Because the core diameter of the first optical fiber 11 is too small, during the process of bundling a plurality of first optical fibers 11, arrangement is required, and the selection of the bundling method will affect the effect of the fiber bundle, coating removal, and a variety of precise process methods such as bonding. The shape of the rear end of the bonding part, round or square, also needs to be considered. Because the end face shape needs to be considered after bundling to match the energy emitted by the laser, to ensure that the optical fiber end face is not burned out.

[0087] Specifically,

[0088] As an embodiment, the bending radius of the first optical fiber 11 is less than 10 mm. The smaller the bending radius, the greater the flexibility of the optical fiber. By setting the bending radius of the first optical fiber 11 to be less than 10 mm, the first optical fiber 11 has better flexibility, so that the laser ablation catheter can easily reach the left and right renal arteries from the trunk of the artery. Specifically, the bending radius of the first optical fiber 11 can be 9 mm or 8 mm or 7 mm or 6 mm, etc.

[0089] As an embodiment, the first optical fiber 11 is a multi-mode optical fiber that can transmit multiple modes at a certain operating wavelength.

[0090] As an embodiment, the core numerical aperture of the first optical fiber 11 is greater than or equal to 0.22 and less than or equal to 0.5. In specific applications, the first optical fiber 11 with a corresponding core numerical aperture can be selected according to actual conditions.

[0091] Exemplarily, the first optical fiber 11 is a quartz optical fiber, which includes a core, a cladding, and a coating layer. The cladding is wrapped around the circumference of the core, and the coating layer is coated on the outside of the cladding. The coating layer contains polyimide and acrylate material, which greatly improves the high-temperature resistance of the coating layer. The cladding is a polymer material that can be applied to relatively low laser power and near-infrared wavelengths.

[0092] As an embodiment, the optical fiber bundle 10 includes at least seven first optical fibers 11. In this way, the laser energy released by the optical fiber bundle 10 is ensured.

[0093] As an embodiment, the laser ablation catheter is provided with a temperature sensing device for acquiring the temperature of the target site.

[0094] Referring to FIG. 2, the temperature sensing device includes a second optical fiber 12 for transmitting a second laser for temperature sensing of the target site and generating a center reflection wavelength. The second optical fiber 12 is placed in the plurality of first optical fibers 11 and is simultaneously accommodated in the optical fiber channel 21 with the first optical fibers 11. In specific applications, the control unit emits the second laser, and the second optical fiber 12 transmits the second laser to the output end (i.e., the distal end). According to the effect of the second optical fiber 12, the second optical fiber 12 reflects the center reflection wave to the sensing analyzer. The control unit can determine the temperature of the target site according to the wavelength of the center reflection wave, and the second optical fiber 12 functions as a temperature sensor. In this way, the temperature of the target site can be monitored in real time when the sympathetic nerve fibers on the adventitia of the renal artery are irradiated with laser, and the temperature is prevented from being too high or too low, thereby improving the stability and safety of laser irradiation. Of course, in other embodiments, the optical fiber bundle 10 can not be provided with the second optical fiber 12. The target site refers to the site that is irradiated with laser.

[0095] As an implementation, the second optical fiber 12 has a bending radius greater than or equal to 10 mm and less than or equal to 25 mm; the second optical fiber 12 has a core diameter greater than or equal to 8 um and less than or equal to 12 um. In this way, the second optical fiber 12 has a certain softness, so that the optical fiber bundle 10 can pass through the blood vessels with various bending degrees.

[0096] As an implementation, the second optical fiber 12 is a single-mode optical fiber. Of course, in other embodiments, the second optical fiber 12 can also be a multi-mode optical fiber.

[0097] As an implementation, the second optical fiber 12 is provided with one or more groups of fiber gratings. In this embodiment, the second optical fiber 12 is provided with a group of fiber gratings. In specific applications, the number of fiber gratings can be set according to actual needs, and the number of fiber gratings is not limited here.

[0098] In this embodiment, the second optical fiber 12 serves as a temperature sensor to sense the temperature of the distal end of the optical fiber bundle 10 at the target site. Further, the second optical fiber 12 can be provided as a resistance temperature device or a thermocouple and the like device that plays a temperature sensing role, wherein the temperature measurement accuracy is + / -0.1℃.

[0099] The temperature sensing device can be a resistance temperature device or a thermocouple, which can be provided on the end face of the output end (i.e. the distal end), or on the balloon assembly 30 mentioned below, for measuring the ambient temperature of the distal end of the catheter in the blood vessel, i.e. the target temperature.

[0100] The resistance temperature device or thermocouple feeds back the detected ambient temperature in the blood vessel to the control system.

[0101] As an implementation, the optical fiber bundle 10 includes one second optical fiber 12. It can be understood that in other embodiments, the optical fiber bundle 10 can also include two or three or four second optical fibers 12. Here, the number of second optical fibers 12 is not limited.

[0102] The output end of the optical fiber bundle is provided with a structure for releasing laser energy in a set direction;

[0103] Alternatively, the output end of the optical fiber bundle is provided with a structure for releasing laser energy in a circumferential direction

[0104] Please refer to FIG. 1 and FIG. 3, the output end of the optical fiber bundle 10 is located at the distal end of the tube structure 20, and has an inclined surface 15 which is at an angle to the elongated axis of the tube structure 20, and the inclined surface 15 is arranged at an angle to the central axis of the renal artery laser ablation catheter 100, and the inclined surface 15 serves as a structure for releasing laser energy in a set direction. Preferably, the angle between the inclined surface 15 and the central axis of the renal artery laser ablation catheter 100 is greater than or equal to 20° and less than or equal to 40°. The output end of the optical fiber bundle 10 is the output end of the first optical fiber 11 and the output end of the second optical fiber 12. The output end of the optical fiber bundle 10 releases laser energy, and by arranging the inclined surface 15 at the output end, the optical fiber bundle 10 releases laser energy in one direction, the directionality of the release of laser energy is stronger, and the laser energy of the optical fiber bundle 10 is concentrated in the same direction, greatly increasing the intensity of the laser energy and avoiding the occurrence of insufficient laser energy. The arrow in FIG. 1 represents the direction of release of laser energy.

[0105] Please refer to FIG. 1 and FIG. 3, the tube structure 20 includes an outer tube 23 and an inner tube 24, the outer tube 23 is sleeved on the periphery of the inner tube 24 and is arranged eccentrically with the inner tube 24 and forms a first optical fiber placement channel 211, and the first optical fiber 11 is arranged in the first optical fiber placement channel 211; the inner tube 24 has a second optical fiber placement channel 212, and the second optical fiber 12 is arranged in the second optical fiber placement channel 212; the optical fiber channel 21 includes the first optical fiber placement channel 211 and the second optical fiber placement channel 212. The cavity of the inner tube 24 forms the second optical fiber placement channel 212. By placing the second optical fiber 12 in the second optical fiber placement channel 212, compared with placing the first optical fiber 11 and the second optical fiber 12 in the same optical fiber placement channel (due to the different radial dimensions of the first optical fiber 11 and the second optical fiber 12, resulting in difficult installation and low optical fiber concentration), installation is faster and more convenient. In this embodiment, the first optical fiber 11 and the second optical fiber 12 are fixed in the optical fiber channel 21 by an adhesive. Of course, as an alternative embodiment, the second optical fiber 12 can be located in the first optical fiber placement channel 211 in specific applications.

[0106] In the embodiment, the outer tube 23 and the inner tube 24 are eccentrically arranged, wherein the outer tube 23 and the inner tube 24 are both cylindrical, and the outer tube 23 and the inner tube 24 are eccentrically arranged, that is, the central axis of the outer tube 23 deviates from the central axis of the inner tube 24, the radial dimension of a part of the first optical fiber placement channel 211 formed thereby is greater than the radial dimension of another part, and after the plurality of first optical fibers 11 are placed in the first optical fiber placement channel 211, the first optical fibers 11 can be arranged in a crescent shape or a crescent-like structure. In this way, the laser released by the output end of the first optical fiber 11 is more concentrated and has more directionality, which is beneficial to increasing the intensity of laser energy in the same direction, that is, increasing the intensity of laser energy irradiated to the sympathetic nerve at the target region. Preferably, the inner tube 24 is inscribed in the outer tube 23, and the cross section of the first optical fiber placement channel 211 formed thereby is crescent-shaped, and after the plurality of first optical fibers 11 are placed in the first optical fiber placement channel 211, the first optical fibers 11 are arranged in a crescent shape.

[0107] Referring to FIGS. 2 and 3, the tube structure 20 further includes a sleeve tube 25, the sleeve tube 25 is arranged at the proximal end of the tube structure 20, the outer tube 23 and the inner tube 24 are arranged at the distal end of the tube structure 20, the input ends of the first optical fibers 11 and the second optical fibers 12 are accommodated in the sleeve tube 25, the output end of the first optical fiber 11 is arranged in the first optical fiber placement channel 211, and the output end of the second optical fiber 12 is arranged in the second optical fiber placement channel 212. Specifically, the cavity of the sleeve tube 25 forms a third optical fiber placement channel 213, the third optical fiber placement channel 213 is communicated with the first optical fiber placement channel 211 and the second optical fiber placement channel 212, and the proximal ends of the first optical fibers 11 and the second optical fibers 12 are accommodated in the third optical fiber placement channel 213.

[0108] In the embodiment, at the proximal end of the tube structure 20, the second optical fiber 12 is arranged at the middle position of the optical fiber bundle 10, that is, the plurality of first optical fibers 11 are arranged around the second optical fiber 12 with the second optical fiber 12 as the center. It can be understood that in other embodiments, the second optical fiber 12 can also be arranged at other positions of the optical fiber bundle 10, such as positions away from the center of the optical fiber bundle 10.

[0109] Referring to FIG. 1, the laser ablation catheter further includes a balloon assembly 30, the balloon assembly 30 is sealingly sleeved at the distal end of the optical fiber bundle 10 and the tube structure 20, so that the distal end of the optical fiber bundle 10 is arranged in the balloon assembly 30.

[0110] Referring to FIG. 1, the balloon assembly 30 includes a first balloon 31 and a second balloon 32, the first balloon 31 and the second balloon 32 are both sealingly sleeved at the distal end of the optical fiber bundle 10, the second balloon 32 is sleeved at the periphery of the first balloon 31, and the distal end of the tube structure 20 and the optical fiber bundle 10 is arranged in the first balloon 31, that is, the inclined surface 15 at the distal end of the optical fiber bundle 10 is arranged in the first balloon 31. Specifically, the first balloon 31 and the second balloon 32 are both sealingly sleeved at the distal end of the tube structure 20.

[0111] The tube structure 20 is further provided with a first liquid conducting channel and a second liquid conducting channel. The first liquid conducting channel is in communication with the first balloon 31 and is used to at least deliver a first liquid to the first balloon 31. The second liquid conducting channel is in communication with the second balloon 32 and is used to at least deliver a second liquid to the second balloon 32. The first liquid can be a cooling liquid, such as cooling water. The cooling liquid is input into the first balloon 31 through the first liquid conducting channel, and can cool the distal end of the optical fiber bundle 10 to avoid damage caused by high temperature of the optical fiber bundle 10 during laser irradiation. In a specific application, the cooling liquid absorbs heat from the distal end of the optical fiber bundle 10 after being input into the first balloon 31 through the first liquid conducting channel, and is then output from the first liquid conducting channel. The second liquid can be a radiopaque solution or normal saline, etc. The second liquid is input into the second balloon 32 through the second liquid conducting channel, and the second balloon 32 is inflated by pressurizing the second liquid in the second balloon 32, so that the second balloon 32 can tightly adhere to the inner wall of the renal artery, thereby positioning the renal artery laser ablation catheter 100 and improving the stability of the renal artery laser ablation catheter 100 during laser irradiation.

[0112] It can be understood that, in other embodiments, the balloon assembly 30 includes the first balloon 31, and it is also possible that the tube structure 20 and the distal end of the optical fiber bundle 10 are arranged in the first balloon 31; or the balloon assembly 30 includes the second balloon 32, and it is also possible that the tube structure 20 and the distal end of the optical fiber bundle 10 are arranged in the second balloon 32. When the balloon assembly 30 includes the second balloon 32, the distal end of the optical fiber bundle 10 can also pass through the second balloon 32 and extend to the outside of the second balloon 32.

[0113] As an implementation manner, the first balloon 31 and the second balloon 32 can be connected to the tube structure 20 by heat staking or laser welding to ensure the reliability of the connection.

[0114] Please refer to FIG. 1 and FIG. 3, the renal artery laser ablation catheter 100 further includes a guide wire 40, which is arranged in the second optical fiber arrangement channel 212. By controlling the guide wire 40, the distal end of the tube structure 20 can be guided to the target site of the renal artery.

[0115] Please refer to FIG. 1 and FIG. 4, the second laser ablation catheter 100 provided in the embodiment is different from the first laser ablation catheter in that the structure of the distal end of the optical fiber bundle 10 is different, specifically embodied in that the distal end of the optical fiber bundle 10 has an inclined surface 15; while in the embodiment, the distal end of the optical fiber bundle 10 has a tapered tip 13.

[0116] Please refer to FIG. 4, the output end of the optical fiber bundle 10 is provided with a structure for releasing laser energy in the circumferential direction, and the distal end of the optical fiber bundle 10 has a tapered tip 13. In this way, the optical fiber bundle 10 releases the first laser along the circumferential direction, and the first laser can cover the renal artery blood vessel in 360°, greatly improving the operation efficiency of the RDN procedure. Of course, in specific applications, the distal end of the optical fiber bundle 10 can also have other shaped tips, such as a circular truncated cone.

[0117] As an embodiment, the taper angle of the tapered tip 13 is greater than or equal to 30° and less than or equal to 80°. Specifically, the taper angle can be 30° or 50° or 60° or 70° or 80°, etc.

[0118] In addition to the above differences, the laser ablation catheter 100 provided by the present embodiment can be designed with reference to the first laser ablation catheter, and will not be described in detail here.

[0119] Please refer to FIG. 1 and FIG. 5, the present embodiment provides a third laser ablation catheter, which differs from the first laser ablation catheter in that the structure of the distal end of the optical fiber bundle 10 is different, specifically embodied in that: in the first laser ablation catheter, the distal end of the optical fiber bundle 10 has an inclined surface 15; while in the third laser ablation catheter, the distal end of the optical fiber bundle 10 has a tapered groove 14.

[0120] By providing the tapered groove 14 at the distal end of the optical fiber bundle 10, the optical fiber bundle 10 can release the first laser along the circumferential direction, and the first laser can cover the renal artery blood vessel in 360°.

[0121] As an embodiment, as shown in FIG. 5, the opening end of the tapered groove 14 is a small distance away from the end face of the optical fiber bundle 10, that is, the end face of the optical fiber bundle 10 is a distance away from the emitting surface, and the application effect is better. The taper angle of the tapered groove 14 is greater than or equal to 30° and less than or equal to 80°. Specifically, the taper angle can be 30° or 50° or 60° or 70° or 80°, etc., and the direction of the arrow in FIG. 5 is the light emitting method.

[0122] In addition to the above differences, the laser ablation catheter 100 provided by the present embodiment can be designed with reference to the first laser ablation catheter, and will not be described in detail here.

[0123] Embodiment two:

[0124] As shown in FIG. 6 and FIG. 7, the laser ablation catheter 100 provided by the present embodiment includes an optical fiber bundle 10 and a tube structure 20, the output end of the optical fiber bundle 10 is located at the distal end of the tube structure 20, and has an inclined surface 15 at an angle to the elongated axis of the tube structure 20. The tube structure 20 is used to accommodate the optical fiber bundle 10, and the optical fiber bundle 10 is bound, thereby improving the aggregation performance of each optical fiber.

[0125] The laser ablation catheter can be applied to various operations, such as excimer laser coronary atherectomy (ELCA) and renal denervation (RDN). The ELCA mainly transmits ultraviolet light pulses to the hardened site through the laser ablation catheter to remove hardened plaques. The RDN can irradiate sympathetic nerve fibers by releasing laser energy to affect the sympathetic nerves, such as destroying the sympathetic nerves. However, the laser ablation catheter in the related art uniformly releases laser energy in multiple directions at the same time, and the laser energy in a certain direction cannot meet the demand at all times. In the embodiment, the output end of the optical fiber bundle 10 releases laser energy, and the output end is provided with an inclined surface 15 to make the optical fiber bundle 10 release laser energy in one direction, that is, release laser energy toward the target area needing laser irradiation. The directionality of the released laser energy is stronger, and the laser energy of the optical fiber bundle 10 is concentrated in the target area, greatly increasing the intensity of the laser energy irradiated to the target area, and avoiding the occurrence of insufficient laser irradiation energy. The arrow in FIG. 6 represents the release direction of the laser energy.

[0126] The laser ablation catheter 100 provided in the embodiment can be applied to various operation scenes, including but not limited to ELCA and RDN.

[0127] As an implementation manner, the output end of the optical fiber bundle 10 is located at the distal end of the tube structure 20 and has the inclined surface 15 at an angle with the extension axis of the tube structure 20. Specifically, the inclined surface 15 forms an included angle greater than or equal to 20° and less than or equal to 40° with the axis in the extension direction of the laser ablation catheter. The included angle is set to be between 20° and 40° to make the laser energy run a short distance from the optical fiber bundle 10 to the ablation site.

[0128] Referring to FIG. 8, the optical fiber bundle 10 includes a plurality of first optical fibers 11, and the core diameter of the first optical fibers 11 is smaller than the core diameter of the optical fiber bundle 10. The first optical fibers are used to transport the first laser and release the first laser at the sympathetic nerves of the target site. In a specific application, the proximal end of the first optical fiber 11 receives the first laser from the control system, and the output end releases the first laser. The released first laser can irradiate the sympathetic nerves of the ablation site, so that the output end of the optical fiber bundle can irradiate the sympathetic nerves of the ablation site. The first laser can be transmitted in a continuous or pulsed form.

[0129] When the first laser is a continuous laser, the output power of the next laser is adjusted;

[0130] When the first laser is a pulsed laser, the output power or frequency of the next laser is adjusted.

[0131] As an embodiment, the bending radius of the first optical fiber 11 is less than 10 mm, and the core diameter of the first optical fiber 11 is less than 200 um. The smaller the bending radius, the greater the flexibility of the optical fiber. In this way, the first optical fiber 11 has better flexibility, so that the laser ablation catheter 100 can enter the blood vessel with a large angle bend, thereby expanding the application range of the laser ablation catheter 100. For example, there is a bend of nearly 90° from the main artery to the left and right renal arteries. The laser ablation catheter 100 provided in the embodiment can easily enter the renal artery from the main artery, thereby being well applied to RDN. In addition, the first optical fiber 11 provided in the embodiment not only enables the optical fiber bundle 10 to easily pass through the blood vessel, but also reduces the power loss of the optical fiber bundle 10 and improves the light transmission efficiency of the optical fiber bundle 10. Preferably, the optical fiber bundle 10 includes at least seven first optical fibers 11, which can effectively ensure the stability of the working performance of the optical fiber bundle 10. It can be understood that in other embodiments, the optical fiber bundle 10 can also include one first optical fiber 11 with a large bending radius.

[0132] As an embodiment, the core numerical aperture of the first optical fiber 11 is greater than or equal to 0.22 and less than or equal to 0.5. In specific applications, the first optical fiber 11 with a corresponding core numerical aperture can be selected according to actual conditions.

[0133] Exemplarily, the first optical fiber 11 is a quartz optical fiber, which includes a core, a cladding, and a coating layer. The cladding is wrapped around the circumference of the core, and the coating layer is coated on the outside of the cladding. The coating layer includes polyimide and acrylate material, which greatly improves the high-temperature resistance of the coating layer. The cladding is a polymer material, which can be applied to relatively low laser power and near-infrared wavelengths.

[0134] Referring to FIGS. 7, 9, and 10, the optical fiber bundle 10 further includes a second optical fiber 12. The second optical fiber 12 is used to sense the temperature of the distal end of the optical fiber bundle 10 at the ablation site. In specific applications, the control system sends a second laser to the second optical fiber 12. According to the effect of the second optical fiber 12, the control system receives the center reflection wavelength of the second optical fiber 12. According to the center reflection wavelength, the temperature of the ablation site at the output end of the optical fiber bundle 10 can be determined. The second optical fiber 12 functions as a temperature sensor. In this way, the temperature of the ablation site can be monitored in real time when the ablation site is irradiated with the first laser, so as to avoid excessively high or low temperature, thereby improving the stability and safety of the first laser irradiation. Of course, in other embodiments, the optical fiber bundle 10 can not be provided with the second optical fiber 12.

[0135] As an implementation, the second optical fiber 12 has a bending radius greater than or equal to 10 mm and less than or equal to 25 mm; the second optical fiber 12 has a core diameter greater than or equal to 8 um and less than or equal to 12 um. In this way, the second optical fiber 12 has a certain softness, so that the optical fiber bundle 10 can pass through the blood vessels with various bending degrees.

[0136] As an implementation, the second optical fiber 12 is provided with one or more groups of fiber gratings. In this embodiment, the second optical fiber 12 is provided with a group of fiber gratings. In specific applications, the number of fiber gratings can be set according to actual needs, and the number of fiber gratings is not limited here.

[0137] In this embodiment, the second optical fiber 12 serves as a temperature sensor to sense the temperature of the distal end of the optical fiber bundle 10 at the ablation site. Further, the second optical fiber 12 can be provided as a resistance temperature device or a thermocouple and the like device that plays a temperature sensing role, wherein the temperature measurement accuracy is + / -0.1℃.

[0138] As an implementation, the optical fiber bundle 10 includes one second optical fiber 12. It can be understood that in other embodiments, the optical fiber bundle 10 can also include two or three or four second optical fibers 12. Here, the number of second optical fibers 12 is not limited.

[0139] As an implementation, the first optical fiber 11 is a multi-mode optical fiber, and the second optical fiber 12 is a single-mode optical fiber or a multi-mode optical fiber. For example, in this embodiment, the first optical fiber 11 is a multi-mode optical fiber, and the second optical fiber 12 is a single-mode optical fiber.

[0140] Please refer to FIGS. 7, 9 and 10, the tube structure 20 includes an outer tube 21 and an inner tube 22, the outer tube 21 is sleeved on the periphery of the inner tube 22 and is eccentrically arranged with the inner tube 22 to form a first optical fiber arrangement channel 23, the distal ends of the plurality of first optical fibers 11 are arranged in the first optical fiber arrangement channel 23, and the cavity of the inner tube 22 forms a second optical fiber arrangement channel 24 for the guide wire to pass through. The second optical fiber 12 can be located in the first optical fiber arrangement channel 23 and share the optical fiber bundle input end and the optical fiber bundle output end with the first optical fiber 11, or can be placed in the second optical fiber arrangement channel 24. In this way, the first optical fiber 11 and the second optical fiber 12 are accommodated. Preferably, the second optical fiber 12 is placed in the second optical fiber arrangement channel 24, which is more convenient and faster to install than placing the first optical fiber 11 and the second optical fiber 12 in the same optical fiber arrangement channel (due to the different radial sizes of the first optical fiber 11 and the second optical fiber 12, resulting in difficult installation and low optical fiber aggregation).

[0141] In the embodiment, the outer tube 21 and the inner tube 22 are arranged at the distal end of the laser ablation catheter 100, the distal end of the first optical fiber 11 is arranged in the first optical fiber arrangement channel 23, and the distal end of the second optical fiber 12 is arranged in the second optical fiber arrangement channel 24. The first optical fiber 11 and the second optical fiber 12 are fixed in the first optical fiber arrangement channel 23 and the second optical fiber arrangement channel 24 by an adhesive respectively.

[0142] In the embodiment, the outer tube 21 and the inner tube 22 are arranged eccentrically, and the outer tube 21 and the inner tube 22 are both cylindrical, and are arranged eccentrically, that is, the central axis of the outer tube 21 deviates from the central axis of the inner tube 22, so that the radial dimension of part of the first optical fiber arrangement channel 23 is greater than the radial dimension of another part, and after a plurality of first optical fibers 11 are arranged in the first optical fiber arrangement channel 23, the first optical fibers 11 can be arranged in a crescent shape or a crescent-like shape. In this way, the laser released by the output end of the optical fiber bundle 10 is more concentrated and directional, which is beneficial to increasing the intensity of laser energy in the same direction. Preferably, the inner tube 22 is inscribed in the outer tube 21, and the cross section of the first optical fiber arrangement channel 23 is crescent-shaped, and after a plurality of first optical fibers 11 are arranged in the first optical fiber arrangement channel 23, the first optical fibers 11 are arranged in a crescent shape.

[0143] In another embodiment, the inner tube 22 can also be replaced by an arc-shaped isolation plate. When this scheme is adopted, the arc-shaped isolation plate separates the cavity of the outer tube 21 into a first cavity and a second cavity, the first cavity forms the first optical fiber arrangement channel 23, and the second cavity forms the second optical fiber arrangement channel 24. Since the isolation plate is arranged in an arc shape, the cross section of the first cavity can be crescent-shaped.

[0144] Please refer to FIG. 7, FIG. 9 to FIG. 11, the tube structure 20 further includes an outer sleeve 25, the outer sleeve 25 is arranged at the proximal end of the laser ablation catheter 100, and the first optical fiber 11 and the second optical fiber 12 are both accommodated in the outer sleeve 25. Specifically, the cavity of the outer sleeve 25 forms a third optical fiber arrangement channel 26, the third optical fiber arrangement channel 26 is communicated with the first optical fiber arrangement channel 23 and the second optical fiber arrangement channel 24, and the proximal end of the first optical fiber 11 and the second optical fiber 12 are both accommodated in the third optical fiber arrangement channel 26.

[0145] As an embodiment, the outer tube 21 and the inner tube 22 are metal tubes, and the outer sleeve 25 is a quartz capillary tube, and the thickness of the quartz capillary tube is greater than the thickness of the metal tube. Exemplarily, the inner diameter of the outer sleeve 25 is arranged to be between 0.40mm and 0.80mm, and the outer diameter is arranged to be between 0.8mm and 1.2mm.

[0146] The laser ablation catheter 100 further includes a balloon assembly, the balloon assembly is sealed to the distal end of the tube structure 20 along the extension direction of the catheter, so that the inclined surface 15 is arranged in the balloon assembly.

[0147] Referring to FIG. 7 and FIG. 9, the balloon assembly includes a first balloon 30 sealingly sleeved to the distal end of the optical fiber bundle 10, and the inclined surface 15 is arranged in the first balloon 30. Specifically, the first balloon 30 is sealingly sleeved to the distal end of the tube structure 20. In this embodiment, the first balloon 30 is sealingly sleeved to the distal end of the outer tube 21.

[0148] The tube structure 20 is further provided with a first liquid conducting channel, which is used at least for conveying a first liquid to the first balloon 30. The first liquid can be a cooling liquid, such as cooling water. By inputting the cooling liquid into the first balloon 30, the distal end of the optical fiber bundle 10 can be cooled to avoid damage caused by excessively high temperature of the optical fiber bundle 10 during laser irradiation. In a specific application, the cooling liquid absorbs heat from the distal end of the optical fiber bundle 10 after being input into the first balloon 30 through the first liquid conducting channel, and then is output from the first liquid conducting channel.

[0149] Referring to FIG. 7 and FIG. 9, the laser ablation catheter 100 further includes a second balloon 40 sleeved to the periphery of the first balloon 30. Specifically, the second balloon 40 is sealingly sleeved to the distal end of the tube structure 20. In this embodiment, the second balloon 40 is sealingly sleeved to the distal end of the outer tube 21 and sleeved to the periphery of the first balloon 30.

[0150] The tube structure 20 is further provided with a second liquid conducting channel, which is used at least for conveying a second liquid to the second balloon 40. The second liquid can be a radiopaque solution or normal saline, etc. By inputting the second liquid into the second balloon 40, and then pressurizing the second liquid in the second balloon 40 to make the second balloon 40 expand, the second balloon 40 can be tightly attached to the inner wall of the blood vessel, thereby playing a role of positioning the laser ablation catheter 100 and improving the stability of the laser ablation catheter 100 during laser irradiation.

[0151] As an implementation manner, the first balloon 30 and the second balloon 40 can be connected to the tube structure 20 by hot melting welding or laser welding to ensure the reliability of the connection.

[0152] As an implementation, the laser ablation catheter 100 further comprises a rotating member connected with the proximal end of the tube structure 20, for driving the optical fiber bundle 10 and the tube structure 20 to rotate around the axial direction of the laser ablation catheter in a preset manner, so that the output laser of the optical fiber bundle can irradiate the ablation site in a 360° angle. Specifically, the rotating member is arranged at the proximal end of the outer sleeve tube 25. By arranging the rotating member, the rotating member is driven to rotate under the action of an external force, thereby driving the tube structure 20 and the optical fiber bundle 10 to rotate 360° around the axial direction of the tube structure 20, and further enabling the laser energy released by the optical fiber bundle 10 to be projected in a ring-shaped manner, which can fully cover the blood vessel in 360° and can irradiate different directions in the blood vessel, thereby greatly improving the effect of laser irradiation. The rotating member can be manually driven to rotate, or can be driven to rotate by intelligent control.

[0153] Referring to FIGS. 6, 7 and 11, the rotating member is a luer adapter 70. Specifically, the luer adapter 70 is mounted at the proximal end of the outer sleeve tube 25, and the luer adapter 70 is manually driven to rotate, thereby driving the tube structure 20 and the optical fiber bundle 10 to rotate.

[0154] Preferably, the preset manner is to emit laser with a time length of 10 seconds or 15 seconds every 45 degrees or 90 degrees. That is, laser with a time length of 10 seconds is emitted every 45 degrees, or laser with a time length of 15 seconds is emitted every 90 degrees.

[0155] Referring to FIGS. 6 and 7, the laser ablation catheter 100 further comprises a guide wire 40, which is arranged in the tube structure 20. By controlling the guide wire 40, the distal end of the tube structure 20 can be guided to the target site of the blood vessel. Specifically, the guide wire 40 is arranged in the second optical fiber arrangement channel 24.

[0156] Referring to FIG. 6, the laser ablation catheter 100 further comprises a catheter seat 60 connected with the proximal end of the tube structure 20, and the catheter seat 60 is provided with a liquid injection port for injecting liquid into the balloon assembly.

[0157] Further, the embodiment of the present application further provides a laser ablation system comprising the laser ablation catheter 100 described above. By adopting the laser ablation catheter 100 described above, laser energy with a large enough intensity is released, which fully meets the treatment requirements.

[0158] As an implementation, the laser ablation system further comprises a control system, the control system is used at least for controlling the laser ablation catheter to output laser with a wavelength of 1064 nm. The laser with a wavelength of 1064 nm has lower absorption in water than other wavelengths of laser, the photon energy can penetrate into the perivascular tissue of the renal artery and cause strong scattering and thermal effect, and effective adventitial injury of the renal artery is generated, and the irradiation effect on the sympathetic nerve fibers is better. Moreover, the renal artery intima has small absorption of the first laser in the wavelength range, and the photo-thermal effect is low, so the damage to the renal artery intima is small.

[0159] Embodiment three:

[0160] As shown in FIG. 12, the renal artery laser ablation system provided by the embodiment of the present application comprises a laser ablation catheter 100, which can be the laser ablation catheter of the above-mentioned embodiments one and two. Referring to FIGS. 1 to 3, the laser ablation catheter 100 comprises an optical fiber bundle 10, and the optical fiber bundle 10 comprises a first optical fiber 11 and a second optical fiber 12. The first optical fiber 11 is used for transporting the first laser and releasing the first laser at the sympathetic nerve of the target site. The second optical fiber 12 is used for transporting the second laser for temperature sensing of the target site and generating a center reflection wavelength, which has a mapping relationship with the temperature of the target site. Specifically, the second optical fiber 12 is an optical fiber grating sensor.

[0161] The first optical fiber 11 releases the first laser at the sympathetic nerve of the target site, i.e. the first laser irradiates the sympathetic nerve, so that a certain effect can be generated on the sympathetic nerve, such as ablation of the sympathetic nerve at the target site, so as to block the signal transmission between the brain and the sympathetic nerve, reduce the overactive sympathetic nerve of the patient with hypertension, and thus play a role in reducing blood pressure.

[0162] The second laser is conducted from the proximal end of the second optical fiber 12 to the distal end of the second optical fiber 12, i.e. the distal end of the optical fiber bundle 10. According to the temperature of the distal end of the optical fiber bundle 10, a center reflection wavelength corresponding to the temperature is generated. Thus, the temperature information of the distal end of the optical fiber bundle 10, i.e. the temperature information of the target site of the renal artery, can be obtained through the center reflection wavelength of the second optical fiber 12. In the table one, the temperatures corresponding to some center reflection wavelengths of the second optical fiber 12 are listed. For example, when the center reflection wavelength is 1548.28 nm, the temperature of the target site is 50℃. The longer the center reflection wavelength is, the higher the temperature of the target site is.

[0163] Table one

[0164] Referring to FIG. 12, the renal artery laser ablation system 100 further comprises a control unit 200, which is at least optically connected with the laser ablation catheter 100 and is used for performing the following steps:

[0165] The first laser is emitted to the first optical fiber, and the first laser is used for irradiating the target site;

[0166] After the second laser is emitted to the second optical fiber, a center reflection wavelength from the second optical fiber is received, and a temperature of the target site is obtained according to the center reflection wavelength;

[0167] The emission energy of the next first laser is determined according to the temperature of the target site.

[0168] In an embodiment, the control unit 200 includes a first laser generation module 210 and a second laser emission module 220; the first laser generation module 210 is used to emit the first laser to the first optical fiber 11; the second laser emission module 220 is used to emit the second laser to the second optical fiber 12, and receive the center reflection wavelength of the second optical fiber 12, and judge the temperature of the distal end of the optical fiber bundle 10, i.e. the temperature of the target site of the renal artery. Preferably, the first laser generation module 210 can be a laser, and the second laser emission module 220 can be a sensor analyzer.

[0169] It should be noted that the solid arrow in FIG. 12 represents the transmission direction of the laser, and the hollow arrow represents the rotation direction of the laser ablation catheter 100; the solid arrow in FIG. 7 represents the release direction of the laser.

[0170] By adopting the above technical scheme, the second optical fiber 12 is arranged to conduct the second laser and generate the center reflection wavelength, and the temperature of the distal end of the optical fiber bundle 10, i.e. the temperature of the target site of the renal artery, can be monitored in real time according to the relationship between the center reflection wavelength and the temperature; the second laser emission module 220 is arranged to emit the second laser to the second optical fiber 12 and receive the center reflection wavelength of the second optical fiber 12, so that the temperature of the target site of the renal artery can be obtained in real time, and the monitored temperature of the target site of the renal artery is compared with a preset temperature (when the first laser irradiates the target site, the temperature of the target site is within the preset temperature range, which indicates that the energy of the first laser meets the requirements and does not affect the laser irradiation effect, and the preset temperature also does not cause damage to the renal artery), to determine whether the current temperature of the target site of the renal artery meets the preset temperature, which helps to adjust the energy of the first laser emitted by the first laser generation module 210, so that the temperature of the target site of the renal artery is within the preset temperature range. Therefore, the renal artery laser ablation system 100 provided in the embodiment can monitor the temperature of the distal end of the optical fiber bundle 10, i.e. the temperature of the target site of the renal artery, in real time, which helps to adjust the temperature of the target site to avoid damage to the renal artery due to excessive temperature, and to avoid affecting the laser irradiation effect due to low temperature, thereby greatly improving the application reliability of the laser energy irradiation of the sympathetic nerve.

[0171] Please refer to FIG. 12, the control unit 200 further comprises a control module 230, the second laser emission module 220 and the first laser generation module 210 are electrically connected with the control module 230; the control module 230 is used to receive the temperature information from the second laser emission module 220, and controls the energy of the first laser emitted by the first laser generation module 210 according to the temperature information, and then controls the temperature of the distal end of the fiber bundle 10. By using the control module 230 to regulate the energy of the first laser emitted by the first laser generation module 210 according to the temperature information, the intelligence of the renal artery laser ablation system 100 is improved, and the manual operation is reduced. Of course, in specific applications, as an alternative embodiment, the renal artery laser ablation system 100 does not set the control module 230, and the operator can also adjust the energy of the first laser emitted by the first laser generation module 210 according to the temperature information of the second laser emission module 220.

[0172] When the renal artery laser ablation system 100 provided by the present embodiment is used, the laser ablation catheter 100 is delivered to the target site of the renal artery, the first laser generation module 210 emits the first laser to the first optical fiber 11, the proximal end of the first optical fiber 11 receives the first laser energy, and after being conducted to the distal end, it is released towards the sympathetic nerve fibers on the adventitia of the renal artery, so as to realize the first laser irradiation of the sympathetic nerve, and the first laser can be transmitted continuously or in pulse form. The second laser emission module 220 emits the second laser to the second optical fiber 12, the proximal end of the second optical fiber 12 receives the second laser energy, and after being conducted to the distal end, according to the temperature of the distal end of the fiber bundle 10, the center reflection wavelength corresponding to the temperature is generated, the second laser emission module 220 receives the center reflection wavelength of the second optical fiber 12, and judges the temperature of the distal end of the fiber bundle 10, that is, the temperature of the target site of the renal artery according to the center reflection wavelength, and transmits the temperature information to the control module 230. The control module 230 receives the temperature information from the second laser emission module 220, compares the temperature information with the preset temperature, that is, compares the monitored temperature of the target site of the renal artery with the preset temperature, and then controls the energy of the first laser emitted by the first laser generation module 210 according to the comparison result, so as to control the temperature of the distal end of the fiber bundle 10.

[0173] As an implementation, the emission energy of the next first laser is determined according to the temperature of the target site, specifically comprising: the first laser is continuous laser, when the acquired temperature of the target site is less than or equal to a preset maximum temperature value and greater than or equal to a preset minimum temperature value, then stop adjusting the emission energy (output power) of the next first laser; when the acquired temperature of the target site is greater than the preset maximum temperature value, then decrease the emission energy (output power) of the next first laser; when the acquired temperature of the target site is less than the preset minimum temperature value, then increase the emission energy (output power) of the next first laser. Alternatively, the first laser is pulse laser, when the acquired temperature of the target site is less than or equal to a preset maximum temperature value and greater than or equal to a preset minimum temperature value, then stop adjusting the output power or frequency of the next first laser; when the acquired temperature of the target site is greater than the preset maximum temperature value, then decrease the output power or frequency of the next first laser; when the acquired temperature of the target site is less than the preset minimum temperature value, then increase the output power or frequency of the next first laser.

[0174] Specifically, when the temperature of the target site of the renal artery is greater than the preset maximum temperature value, the control module 230 controls the first laser generation module 210 to decrease the emission energy of the first laser, so as to reduce the temperature of the target site of the renal artery; when the temperature of the target site of the renal artery is less than the preset minimum temperature value, the control module 230 controls the first laser generation module 210 to increase the emission energy of the first laser, so as to increase the temperature of the target site of the renal artery; when the temperature of the target site of the renal artery is less than or equal to the preset maximum temperature value and greater than or equal to the preset minimum temperature value, that is, within the preset temperature range, the control module 230 controls the first laser generation module 210 to stop adjusting the emission energy of the next first laser, that is, to maintain the original emission energy of the first laser, so as to maintain the temperature of the target site of the renal artery.

[0175] As an implementation, the preset maximum temperature value is 65℃, and the preset minimum temperature value is 50℃. That is, the control module 230 controls the temperature of the distal end of the fiber bundle 10 to be between 50℃ and 65℃. That is, the control module 230 controls the first laser generation module 210 to emit the first laser according to the temperature information from the second laser emission module 220, so as to keep the temperature of the distal end of the fiber bundle 10 between 50℃ and 65℃, thereby avoiding that the temperature of the distal end of the fiber bundle 10 is too low (lower than 50℃) to affect the irradiation effect or treatment effect, and avoiding that the temperature of the distal end of the fiber bundle 10 is too high (higher than 65℃) to cause damage to the renal artery. Preferably, the preset maximum temperature value is 60℃, and the preset minimum temperature value is 55℃. Specifically, the temperature of the distal end of the fiber bundle 10 can be controlled to be 55℃ or 56℃ or 57℃ or 58℃ or 59℃ or 60℃, and the like.

[0176] As an implementation, the wavelength of the first laser is between 800nm and 2100nm. Specifically, the first laser generating module 210 is configured to emit the first laser with a wavelength between 800nm and 2100nm. For example, the emitted first laser has a wavelength of 980nm or 1940nm-2100nm. Preferably, the wavelength of the first laser is between 1034nm and 1094nm. For example, the first laser has a wavelength of 1064nm. The first laser with a wavelength between 1034nm and 1094nm has lower absorption in water than other wavelengths of the first laser, and the photon energy can penetrate the perivascular tissue of the renal artery and cause strong scattering and thermal effects, which can effectively irradiate the adventitia of the renal artery and has a better irradiation effect on sympathetic nerve fibers. Moreover, the intima of the renal artery has low absorption of the first laser with a wavelength in this range, and the photo-thermal effect is low, so the damage to the intima of the renal artery is small.

[0177] As an implementation, the first laser generating module 210 is a semiconductor laser. It is more compact, smaller and more practical than a Nd:YAG solid-state laser or a thulium laser fiber laser.

[0178] As an implementation, the second laser emitting module 220 is configured to emit the second laser with a wavelength of 1550nm. It can be understood that in other embodiments, the second laser emitting module 220 is also configured to emit the second laser with a wavelength of 1310nm.

[0179] Referring to FIGS. 1-3, the laser ablation catheter 100 further comprises a tube structure 20, and the optical fiber bundle 10 is arranged in the tube structure 20. The tube structure 20 protects and restrains the optical fiber bundle 10, avoiding damage to the optical fiber bundle 10 by external objects, and improving the aggregation of the optical fiber bundle 10.

[0180] As an implementation, the tube structure 20 is provided with a first optical fiber arrangement channel 211 and a second optical fiber arrangement channel 212, and at least the distal end of the first optical fiber 11 is arranged in the first optical fiber arrangement channel 211, and at least the distal end of the second optical fiber 12 is arranged in the second optical fiber arrangement channel 212; the distal end of the tube structure 20 is coplanar with the distal end of the optical fiber bundle 10. In this way, the first optical fiber 11 and the second optical fiber 12 are accommodated, and the first optical fiber 11 and the second optical fiber 12 are accommodated in the first optical fiber arrangement channel 211 and the second optical fiber arrangement channel 212, respectively. Compared with accommodating the first optical fiber 11 and the second optical fiber 12 in the same optical fiber arrangement channel (due to the different radial dimensions of the first optical fiber 11 and the second optical fiber 12, resulting in difficult installation and low aggregation of the optical fiber), the installation is faster and more convenient. Of course, in other embodiments, the first optical fiber 11 and the second optical fiber 12 can be accommodated in the first optical fiber arrangement channel 211 or in the second optical fiber arrangement channel 212.

[0181] As an implementation, the cross section of the first fiber placement channel 211 is crescent shaped. In this way, the crescent shape can be formed when the plurality of first fibers 11 are placed in the first fiber placement channel 211. Of course, as an alternative implementation, the cross section of the first fiber placement channel 211 is not crescent shaped, but the area of the first fiber placement channel 211 that can accommodate the first fibers 11 is crescent shaped or approximately crescent shaped. In this way, the crescent shape can be formed when the plurality of first fibers 11 are placed in the first fiber placement channel 211. In addition, the plurality of first fibers 11 can be placed in part of the first fiber placement channel 211 and not arranged in a crescent shape.

[0182] Referring to FIGS. 2 and 3, the tube structure 20 includes an outer sleeve (outer tube) 23 and an inner sleeve 24. The outer sleeve 23 is sleeved on the periphery of the inner sleeve 24 and is arranged eccentrically with the inner sleeve 24, and encloses to form the first fiber placement channel 211. The cavity of the inner sleeve 24 forms the second fiber placement channel 212. In the embodiment, the outer sleeve 23 and the inner sleeve 24 are arranged at the distal end of the fiber bundle 10. The distal end of the first fiber 11 is arranged in the first fiber placement channel 211, and the distal end of the second fiber 12 is arranged in the second fiber placement channel 212. The first fiber 11 and the second fiber 12 are fixed in the first fiber placement channel 211 and the second fiber placement channel 212 by an adhesive, respectively.

[0183] In another embodiment, the inner sleeve 24 can also be replaced by an arc-shaped isolation plate. When this scheme is used, the arc-shaped isolation plate separates the cavity of the outer sleeve 23 into a first cavity and a second cavity. The first cavity forms the first fiber placement channel 211, and the second cavity forms the second fiber placement channel 212. Because the isolation plate is arranged in an arc shape, the cross section of the first cavity can be crescent shaped.

[0184] Referring to FIGS. 1 to 4, the tube structure 20 further includes an outer sleeve 25 arranged at the proximal end of the fiber bundle 10. The first fiber 11 and the second fiber 12 are both accommodated in the outer sleeve 25. Specifically, the cavity of the outer sleeve 25 forms a third fiber placement channel 1231. The third fiber placement channel 1231 is connected to the first fiber placement channel 211 and the second fiber placement channel 212. The proximal end of the first fiber 11 and the proximal end of the second fiber 12 are both accommodated in the third fiber placement channel 1231. A rotating member is arranged in the outer sleeve 25.

[0185] As an implementation, the outer sleeve 23 and the inner sleeve 24 are metal tubes, and the outer sleeve 25 is a quartz capillary tube. The thickness of the quartz capillary tube is greater than the thickness of the metal tube. For example, the inner diameter of the outer sleeve 25 is arranged to be between 0.40 mm and 0.80 mm, and the outer diameter is arranged to be between 0.8 mm and 1.2 mm.

[0186] Please refer to FIG. 2 and FIG. 3, the output end of the optical fiber bundle 10 is located at the distal end of the tube structure 20, and has an inclined surface 153 which is at an angle to the elongated axis of the tube structure 20. That is, the inclined surface 153 is arranged at an angle to the elongated axis of the tube structure 20, that is, there is an angle between the elongated axis of the tube structure 20 and the projection of the inclined surface 153 on the elongated axis of the tube structure 20. The output end of the optical fiber bundle 10, that is, the distal end of the optical fiber bundle 10, releases laser energy, and by arranging the inclined surface 153 at the distal end, the optical fiber bundle 10 releases laser energy in a certain direction, the directionality of the release of laser energy is stronger, the laser energy of the optical fiber bundle 10 is concentrated in the same direction, greatly increasing the intensity of the laser energy, and avoiding the occurrence of insufficient laser energy.

[0187] As an embodiment, the angle between the inclined surface 153 and the axis in the extension direction of the laser ablation catheter 100 is greater than or equal to 20° and less than or equal to 40°. That is, the angle is greater than or equal to 20° and less than or equal to 40°. In this way, the laser energy runs a proper distance from the optical fiber bundle 10 to the target site, which is beneficial to the directionality of light emission.

[0188] As an embodiment, the proximal end of the optical fiber bundle 10 is circular or hexagonal, that is, the first optical fiber 11 and the second optical fiber 12 are arranged together in a circular or hexagonal shape at the proximal end, which is beneficial to the formation of a light spot and coupling efficiency.

[0189] As an embodiment, the laser ablation catheter 100 further comprises a rotating member (not shown in the figure), which is arranged at the proximal end of the optical fiber bundle 10 and used to drive the optical fiber bundle 10 to rotate. By arranging the rotating member, the rotating member is driven to rotate under the action of an external force, thereby driving the optical fiber bundle 10 to rotate, that is, to rotate 360° around the axial direction of the laser ablation catheter 100, and then the laser energy released by the optical fiber bundle 10 is projected in a ring shape, which can fully cover the blood vessel in 360°, and can irradiate different directions in the blood vessel, greatly improving the laser irradiation effect. The rotating member can be driven to rotate manually or intelligently.

[0190] As an embodiment, the rotating member is a luer adapter. The luer adapter is arranged at the proximal end of the optical fiber bundle 10.

[0191] As an embodiment, the rotating member is configured to drive the optical fiber bundle 10 to rotate by a preset angle within a preset time; and the first laser generating module 210 is configured to emit the first laser to the first optical fiber 11 at least when the optical fiber bundle 10 rotates. The first laser generating module 210 emits the first laser to the first optical fiber 11 when the optical fiber bundle 10 rotates, and the first laser is released at the distal end of the optical fiber bundle 10 through the conduction of the first optical fiber 11, so that the first optical fiber 11 releases laser energy when the optical fiber bundle 10 rotates, and the laser energy is projected in a ring shape, which can fully cover the blood vessel in 360°.

[0192] As an embodiment, the preset time is 6s to 15s, and the preset angle is 30° to 90°. Specifically, the preset time is 6s, 8s, 10s, 12s, 14s, 15s, etc., and the preset angle is 30°, 45°, 60°, 75°, 90°, etc. For example, the rotating member drives the optical fiber bundle to rotate 90° in 6s, 30° in 15s, 45° in 10s, or 90° in 15s.

[0193] In one embodiment, the optical fiber bundle 10 includes a plurality of first optical fibers 11, each having a core diameter smaller than the core diameter of the optical fiber bundle 10. Specifically, the bending radius of the first optical fibers 11 is less than 10 mm, and / or the core diameter of the first optical fibers 11 is less than 200 μm. The smaller the bending radius, the greater the flexibility of the optical fiber. This configuration ensures the flexibility of the first optical fibers 11, enabling the laser ablation catheter 100 to enter blood vessels with sharp bends. For example, if there is a nearly 90° bend from the main artery to the left and right renal arteries, the laser ablation catheter 100 provided in this embodiment can easily enter the renal arteries from the main artery, making it well suited for RDN surgery. Furthermore, the first optical fibers 11 provided in this embodiment not only facilitate the optical fiber bundle 10's passage through blood vessels, but also reduce its power loss and improve its light transmission efficiency. Preferably, the optical fiber bundle 10 includes at least seven first optical fibers 11, effectively ensuring the stability of the optical fiber bundle 10's operating performance. It is understood that in other embodiments, the optical fiber bundle 10 may also include a first optical fiber 11 with a large bending radius.

[0194] As an embodiment, the core numerical aperture of the first optical fiber 11 is greater than or equal to 0.22 and less than or equal to 0.5. In specific applications, the first optical fiber 11 with a corresponding core numerical aperture can be selected according to actual conditions.

[0195] Exemplarily, the first optical fiber 11 is a quartz optical fiber, comprising a core, a cladding, and a coating. The cladding surrounds the core, and the coating is applied to the outside of the cladding. The coating comprises polyimide and acrylate materials, significantly improving its high-temperature resistance. The cladding is a polymer material suitable for use with relatively low laser power and near-infrared wavelengths.

[0196] In one embodiment, the multiple first optical fibers 11 are arranged in a crescent shape. Specifically, the cross-sections of the multiple first optical fibers 11 form a crescent shape. This allows the first laser light emitted from the distal end of the optical fiber bundle 10 to be more concentrated and directional, thereby increasing the intensity of the laser energy in the same direction, specifically increasing the intensity of the laser energy directed at the target area to be irradiated.

[0197] As an implementation, the second optical fiber 12 has a bending radius greater than or equal to 10 mm and less than or equal to 25 mm; the second optical fiber 12 has a core diameter greater than or equal to 8 um and less than or equal to 12 um. In this way, the second optical fiber 12 has a certain softness, so that the optical fiber bundle 10 can pass through blood vessels of various curvatures.

[0198] As an implementation, the second optical fiber 12 is provided with one or more groups of fiber gratings. In this embodiment, the second optical fiber 12 is provided with a group of fiber gratings. In specific applications, the number of fiber gratings can be set according to actual needs, and the number of fiber gratings is not limited here.

[0199] In this embodiment, the second optical fiber 12 serves as a temperature sensor to sense the temperature of the distal end of the optical fiber bundle 10 at the target site. Further, the second optical fiber 12 can be provided as a resistance temperature device or a thermocouple and the like device that plays a temperature sensing role, wherein the temperature measurement accuracy is + / -0.1℃.

[0200] As an implementation, the optical fiber bundle 10 includes one second optical fiber 12. It can be understood that in other embodiments, the optical fiber bundle 10 can also include at least two second optical fibers 12. Here, the number of second optical fibers 12 is not limited.

[0201] As an implementation, the first optical fiber 11 is a multi-mode optical fiber, and the second optical fiber 12 is a single-mode optical fiber or a multi-mode optical fiber. For example, in this embodiment, the first optical fiber 11 is a multi-mode optical fiber, and the second optical fiber 12 is a single-mode optical fiber.

[0202] Please refer to FIGS. 2-4, the laser ablation catheter 100 further includes a balloon assembly 30, the balloon assembly 30 is sealingly sleeved on the distal end of the optical fiber bundle 10, so that the distal end of the optical fiber bundle 10 is arranged in the balloon assembly 30.

[0203] Please refer to FIGS. 2-4, the balloon assembly 30 includes a first balloon 31 and a second balloon 32; the first balloon 31 and the second balloon 32 are both sealingly sleeved on the distal end of the optical fiber bundle 10, and the second balloon 32 is sleeved on the periphery of the first balloon 31, and the distal end of the optical fiber bundle 10 is arranged in the first balloon 31, that is, the inclined surface 153 of the distal end of the optical fiber bundle 10 is arranged in the first balloon 31. Specifically, the first balloon 31 and the second balloon 32 are both sealingly sleeved on the distal end of the tube structure 20.

[0204] The tube structure 20 is further provided with a first liquid conducting channel (not shown in the figure) and a second liquid conducting channel (not shown in the figure). The first liquid conducting channel is in communication with the first balloon 31 and is used at least for conveying a first liquid to the first balloon 31. The second liquid conducting channel is in communication with the second balloon 32 and is used at least for conveying a second liquid to the second balloon 32. The first liquid can be a cooling liquid, such as cooling water. The cooling liquid is input into the first balloon 31 through the first liquid conducting channel, so as to cool the distal end of the optical fiber bundle 10, thereby avoiding damage to the optical fiber bundle 10 due to excessively high temperature during laser irradiation. In a specific application, the cooling liquid absorbs heat from the distal end of the optical fiber bundle 10 after being input into the first balloon 31 through the first liquid conducting channel, and is then output from the first liquid conducting channel. The second liquid can be a radiopaque solution or normal saline, etc. The second liquid is input into the second balloon 32 through the second liquid conducting channel, and the second balloon 32 is inflated by pressurizing the second liquid in the second balloon 32, so as to tightly adhere to the inner wall of the renal artery, thereby positioning the laser ablation catheter 100 and improving the stability of the laser ablation catheter 100 during laser irradiation.

[0205] It can be understood that, in other embodiments, the balloon assembly 30 includes the first balloon 31, and it is also possible that the distal end of the optical fiber bundle 10 is arranged in the first balloon 31; or the balloon assembly 30 includes the second balloon 32, and it is also possible that the distal end of the optical fiber bundle 10 is arranged in the second balloon 32. When the balloon assembly 30 includes the second balloon 32, the distal end of the optical fiber bundle 10 can also pass through the second balloon 32 and extend to the outside of the second balloon 32.

[0206] As an implementation manner, the first balloon 31 and the second balloon 32 can be connected to the tube structure 20 by hot melting welding or laser welding, so as to ensure the reliability of the connection.

[0207] Referring to FIGS. 2 to 4, the laser ablation catheter 100 further includes a guide wire 40, which is arranged in the inner sleeve 24, i.e., the guide wire 40 is arranged in the second optical fiber arrangement channel 212. By arranging the guide wire 40, the distal end of the laser ablation catheter 100 can be guided to reach the target site of the renal artery.

[0208] Referring to FIG. 12, the renal artery laser ablation system 100 further includes a beam combiner 300 and a collimating lens 400. The beam combiner 300 is used to integrate the first laser and the second laser to form a combined light beam, and the collimating lens 400 is used to transmit the combined light beam to the laser ablation catheter 100. By using the beam combiner 300, the optical fiber coupling system can be simplified.

[0209] Further, the embodiment of the present application also provides a method for regulating and controlling the renal artery laser ablation system, comprising the steps of:

[0210] S10, emitting first laser and second laser, the first laser is used for irradiating the sympathetic nerve of the target site, and the second laser is used for triggering the temperature of the target site. In an embodiment, the first laser is emitted by the first laser generating module of the control unit, and the second laser is emitted by the second laser emitting module of the control unit.

[0211] S20, acquiring the temperature of the target site. In an embodiment, the second laser emitting module receives the center reflection wavelength from the second optical fiber, and acquires the temperature of the target site according to the center reflection wavelength.

[0212] S30, determining the emission energy of the first laser in the next time according to the temperature of the target site. In an embodiment, the control module of the control unit determines the energy of the first laser generating module emitting the first laser in the next time according to the temperature of the target site.

[0213] As an implementation form, the determination of the emission energy of the first laser in the next time according to the temperature of the target site specifically comprises the following steps:

[0214] When the acquired temperature of the target site is less than or equal to the preset maximum temperature value and greater than or equal to the preset minimum temperature value, the emission energy of the first laser in the next time is stopped adjusting; in an embodiment, the control module does not adjust the energy of the first laser generating module emitting the first laser in the next time.

[0215] When the acquired temperature of the target site is greater than the preset maximum temperature value, the emission energy of the first laser in the next time is reduced; in an embodiment, the control module controls the first laser generating module to reduce the energy of the first laser emitting in the next time.

[0216] When the acquired temperature of the target site is less than the preset minimum temperature value, the emission energy of the first laser in the next time is increased. In an embodiment, the control module controls the first laser generating module to increase the energy of the first laser emitting in the next time.

[0217] As an implementation form, the preset maximum temperature value is 60℃, and the preset minimum temperature value is 55℃. That is, when the acquired temperature of the target site is less than or equal to 60℃ and greater than or equal to 55℃, the emission energy of the first laser in the next time is stopped adjusting; when the acquired temperature of the target site is greater than 60℃, the emission energy of the first laser in the next time is reduced; when the acquired temperature of the target site is less than 55℃, the emission energy of the first laser in the next time is increased.

[0218] As an implementation, the first laser is emitted, in particular, the wavelength of the first laser is between 1034 nm and 1094 nm. Preferably, the wavelength of the first laser is 1064 nm.

[0219] The above merely provides the preferred embodiments of the present application, but does not limit the patent scope of the present application. Any equivalent structure variation or direct / indirect application in other related technical fields made based on the contents of the present application specification and drawings should be included in the patent protection scope of the present application.

Claims

1. A laser ablation catheter, characterized in that: The invention comprises a tube structure and an optical fiber bundle. The tube structure has an optical fiber channel. The optical fiber bundle is accommodated in the optical fiber channel. The optical fiber bundle has an output end. The output end is located at the far end of the tube structure.

2. The laser ablation catheter according to claim 1, wherein: The laser ablation catheter is a renal artery laser ablation catheter. The optical fiber bundle includes multiple first optical fibers with core diameters less than 200 μm. The first optical fibers are used to transmit first lasers for irradiating sympathetic nerves. The first optical fibers are placed in the extension direction of the optical fiber channel.

3. The laser ablation catheter according to claim 2, wherein: The bending radius of the first optical fiber is less than 10 mm; and / or the first optical fiber is a multimode optical fiber.

4. The laser ablation catheter according to claim 2, wherein: The laser ablation catheter is provided with a temperature sensor for acquiring the temperature of the target site.

5. The laser ablation catheter according to claim 4, characterized in that: The temperature sensing device includes a second optical fiber, the second optical fiber is used to transmit a second laser that senses the temperature of the target site and generates a central reflection wavelength, the second optical fiber is placed in the plurality of first optical fibers, and is accommodated in the optical fiber channel together with the first optical fibers; Alternatively, the temperature sensor device is a resistance temperature device or a thermocouple.

6. The laser ablation catheter according to claim 5, wherein: The bending radius of the second optical fiber is greater than or equal to 10 mm and less than or equal to 25 mm; and / or the core diameter of the second optical fiber is greater than or equal to 8 um and less than or equal to 12 um.

7. The laser ablation catheter according to claim 2, wherein: The output end of the optical fiber bundle is provided with a structure for releasing laser energy in a set direction; Alternatively, the output end of the optical fiber bundle is provided with a structure for releasing the laser energy in a circumferential direction.

8. The laser ablation catheter according to claim 2, wherein: The laser ablation catheter further comprises a balloon assembly, which is sealed and sleeved on the distal end of the tube structure, so that the distal ends of the tube structure and the optical fiber bundle are arranged inside the balloon assembly.

9. The laser ablation catheter according to claim 5, wherein: The tube structure includes an inner tube and an outer tube; The outer tube is sleeved on the periphery of the inner tube and is eccentrically arranged with the inner tube to enclose a first optical fiber placement channel, and the first optical fiber is arranged in the first optical fiber placement channel; The inner tube has a second optical fiber placement channel, and the second optical fiber is arranged in the second optical fiber placement channel; The optical fiber channel includes the first optical fiber placement channel and the second optical fiber placement channel.

10. The laser ablation catheter according to claim 1, wherein: The tube structure is a slender tube structure, comprising an inner tube and an outer tube; the outer tube is sleeved on the periphery of the inner tube and is eccentrically arranged with the inner tube to enclose a first optical fiber placement channel, and the inner tube is used for the guide wire to pass through; The output end of the optical fiber bundle is located at the distal end of the tube structure and has an inclined surface that is angled with the extended axis of the tube structure; The optical fiber bundle includes a plurality of first optical fibers, the core diameter of the first optical fibers being smaller than the core diameter of the optical fiber bundle; the plurality of first optical fibers are arranged in the first optical fiber placement channel.

11. The laser ablation catheter according to claim 10, wherein: The laser ablation catheter also includes a rotating member, which is connected to the proximal end of the tube structure and is used to drive the tube structure and the optical fiber bundle to rotate around the axis of the laser ablation catheter in a preset manner, so that the output laser of the optical fiber bundle can irradiate the area to be ablated at an angle of 360°.

12. The laser ablation catheter according to claim 11, wherein: The rotating member is connected to the proximal end of the tube structure and is used to drive the tube structure and the optical fiber bundle to rotate around the axial direction of the laser ablation catheter in a preset manner, so that the output laser of the optical fiber bundle can irradiate the part to be ablated at an angle of 360 degrees, specifically including: The rotating member is a Luer adapter, The preset mode is to emit laser light once every 45 degrees or 90 degrees for 10 seconds or 15 seconds.

13. The laser ablation catheter according to claim 10, wherein: The laser ablation catheter further comprises a balloon assembly, which is sealed and sleeved on the distal end of the tube structure along the extension direction of the catheter, so that the inclined surface is arranged inside the balloon assembly.

14. The laser ablation catheter according to claim 9 or 13, characterized in that: The balloon assembly includes a first balloon and / or a second balloon; The first balloon and / or the second balloon are both sealed and sleeved on the distal end of the tube structure or the optical fiber bundle, and the second balloon is sleeved on the periphery of the first balloon.

15. The laser ablation catheter according to claim 7 or 10, characterized in that: The output end of the optical fiber bundle is an inclined surface; the inclined surface is arranged at an angle with the central axis of the laser ablation catheter, and the angle is greater than or equal to 20° and less than or equal to 40°; Alternatively, the output end of the optical fiber bundle is a tapered tip or a tapered groove, the tapered angle of the tapered tip or the tapered groove is greater than or equal to 30° and less than or equal to 80°, or the output end of the optical fiber bundle is a truncated cone tip.

16. The laser ablation catheter according to claim 11, wherein: The optical fiber bundle further includes a second optical fiber, which is located in the first optical fiber placement channel and shares the optical fiber bundle input end and the optical fiber bundle output end with the first optical fiber, or the second optical fiber is placed in the inner tube; the second optical fiber is used to sense the temperature of the distal end of the optical fiber bundle at the site to be ablated; Alternatively, the laser ablation catheter is provided with a temperature sensor for acquiring the temperature of the target site.

17. The laser ablation catheter according to claim 10, wherein: The bending radius of the first optical fiber is less than 10 mm; and / or the core diameter of the first optical fiber is less than 200 um.

18. The laser ablation catheter according to claim 16, wherein: The bending radius of the second optical fiber is greater than or equal to 10 mm and less than or equal to 25 mm; and / or the core diameter of the second optical fiber is greater than or equal to 8 um and less than or equal to 12 um.

19. The laser ablation catheter according to claim 13, wherein: Also includes: A catheter seat is connected to the proximal end of the tube structure and is provided with a liquid injection port for injecting liquid into the balloon assembly.

20. A laser ablation system, characterized in that: Comprising the laser ablation catheter according to any one of claims 1 to 19.

21. The laser ablation system according to claim 20, wherein: It also includes a control system, which is at least used to control the laser ablation catheter to output laser light with a wavelength of 1064 nm.

22. A laser ablation system, characterized in that: The laser ablation system is a renal artery laser ablation system, comprising a laser ablation catheter according to any one of claims 1 to 19, wherein the optical fiber bundle of the laser ablation catheter comprises a first optical fiber and a second optical fiber, the first optical fiber being used to deliver a first laser and release the first laser to the sympathetic nerve at a target site, and the second optical fiber being used to deliver a second laser that senses the temperature of the target site and generates a central reflection wavelength; A control unit, the control unit being connected to at least the optical path of the laser ablation catheter and configured to perform the following steps: emitting the first laser light toward the first optical fiber, where the first laser light is used to irradiate a target site; After emitting the second laser toward the second optical fiber, receiving a central reflection wavelength from the second optical fiber, and acquiring a temperature of a target portion according to the central reflection wavelength; The energy of the first laser beam emitted next time is determined according to the temperature of the target part.

23. The laser ablation system according to claim 22, wherein: The receiving of the central reflection wavelength from the second optical fiber and acquiring the temperature of the target portion according to the central reflection wavelength specifically includes: the central reflection wavelength and the temperature of the target portion are in a mapping relationship.

24. A method for controlling a laser ablation system, characterized in that: A method for controlling a laser ablation system according to any one of claims 22 to 23, comprising the following steps: emitting a first laser and a second laser, wherein the first laser is used to irradiate the sympathetic nerves of the target site, and the second laser is used to trigger the temperature sensing of the target site; Obtain the temperature of the target area; The energy of the first laser beam emitted next time is determined according to the temperature of the target site.

25. The control method of the laser ablation system according to claim 24, characterized in that: The step of determining the emission energy of the first laser beam for the next time according to the temperature of the target part specifically includes the following steps: The first laser uses a continuous laser, and when the temperature of the target part obtained is less than or equal to a preset maximum temperature value and greater than or equal to a preset minimum temperature value, the output power of the first laser is stopped from being adjusted for the next time; When the temperature of the target part is greater than the preset maximum temperature value, reducing the output power of the first laser for the next time; When the temperature of the target part is lower than the preset minimum temperature, the output power of the first laser is increased next time; Alternatively, the first laser is a pulsed laser, and when the temperature of the target part is less than or equal to a preset maximum temperature value and greater than or equal to a preset minimum temperature value, the output power or frequency of the first laser is stopped from being adjusted for the next time; When the temperature of the target part is greater than the preset maximum temperature value, the output power or frequency of the first laser is reduced next time; When the temperature of the target part is lower than the preset minimum temperature value, the output power or frequency of the first laser is increased next time.

26. The control method of the laser ablation system according to claim 25, characterized in that: The preset maximum temperature value is 60°C, and the preset minimum temperature value is 55°C.

27. The control method of a laser ablation system according to any one of claims 24 to 26, characterized in that: The emitting of the first laser specifically comprises: The wavelength of the first laser is between 1034 nm and 1094 nm.

Images