CN219700103U - Laser ablation catheter and laser ablation system - Google Patents

Abstract

The utility model relates to a laser ablation catheter and a laser ablation system. The laser ablation catheter comprises a catheter main body, a sleeve and an optical fiber bundle; the optical fiber bundle is arranged in the catheter main body through the sleeve; the proximal end of the catheter body is provided with a sleeve, a sleeve is arranged in the sleeve, the sleeve is connected with the outermost optical fibers in the optical fiber bundle in a hot-press welding mode, and adjacent optical fibers in the optical fiber bundle are welded through hot extrusion of the sleeve. When the sleeve is heated and extruded, the sleeve is contracted inwards, the optical fibers penetrating through the sleeve are synchronously extruded, the cross section of the proximal end of the optical fibers can be changed from a round shape to a hexagonal shape after the proximal end of the optical fibers are extruded by the sleeve, so that the sleeve can be welded with the optical fibers at the outermost layer in the optical fiber bundle and the adjacent optical fibers in the optical fiber bundle, and the glue-free fixation of the proximal end of the optical fibers on the catheter main body is realized.

Description

Laser ablation catheter and laser ablation system

Technical Field

The utility model relates to the technical field of medical instruments, in particular to a laser ablation catheter and a laser ablation system.

Background

The Chinese cardiovascular morbidity and mortality still show an increasing trend, and cardiovascular diseases are still the first risk factors threatening the health of people. Atherosclerosis is a common disease severely threatening human health, which can cause thickening of arterial walls and loss of elasticity, and can lead to coronary heart disease and cerebrovascular disease. Atherosclerosis may involve all large and medium-sized arteries, including the coronary, carotid and cerebral arteries, the aorta and its branches, and the main arteries of the extremities. For cardiovascular diseases, clinical treatment schemes often use means such as drug treatment, open surgery and interventional therapy. The interventional therapy has been developed most rapidly in recent years, and has become an indispensable therapeutic means due to the advantages of being minimally invasive, rapid, high in safety and the like.

The common interventional therapy for atherosclerosis aims at dredging embolism and recovering blood supply, and common means include medicine thrombolysis, mechanical thrombolysis, spiral grinding thrombus, laser thrombolysis and the like. Wherein, the laser thrombolysis has unique advantages for common balloon non-passable lesions, chronic total occlusion lesions, restenosis in the stent, and the like. The laser thrombolysis is to put a laser ablation catheter into a target position in a patient body in a minimally invasive intervention mode, and to conduct laser energy with short wavelength, short pulse width and high peak power generated by connected external laser generating equipment to the target position, so as to ablate the target position to achieve a therapeutic effect.

In order to achieve both the trafficability and the large energy transmission in the blood vessels of the human body, the laser ablation catheter generally uses an optical fiber bundle composed of a plurality of optical fibers with diameters reaching the micron order to conduct the laser energy, wherein how to fix the optical fibers together is a great design and process difficulty in assembling the laser ablation catheter. In the related art, an adhesive such as epoxy is used to bond the proximal ends of a plurality of optical fibers together. However, when laser energy of short wavelength, short pulse width and high peak power, which is pursued in ablation treatment, is input, the adhesive on the proximal end face of the optical fiber bundle absorbs the laser radiation energy to generate local hot spots and expands to cause extrusion damage to the optical fiber, and other adhesive residues which are not completely vaporized are mixed after the adhesive is heated and vaporized, so that the adhesive residues are covered on the end face of the optical fiber to reduce the energy transmission efficiency of the whole laser ablation catheter or directly damage the whole laser ablation catheter and cannot be used.

Disclosure of Invention

In view of the above, it is desirable to provide a laser ablation catheter and a laser ablation system.

A laser ablation catheter comprising: a catheter body, a sleeve, a ferrule, and a fiber optic bundle;

the optical fiber bundle is arranged in the catheter main body through the sleeve, and an output part is formed at the distal end of the catheter main body;

the proximal end of the catheter main body is provided with the sleeve, the sleeve is arranged in the sleeve, the sleeve is connected with the outermost optical fibers of the optical fiber bundles in a hot-pressing welding mode, and adjacent optical fibers in the optical fiber bundles are welded through hot pressing of the sleeve.

In one embodiment, the proximal end of each optical fiber comprises a core and a cladding over the core, the ferrule being fused to the cladding of the outermost optical fiber; the distal end and the middle part of each optical fiber comprise a fiber core, a cladding coated on the fiber core and a coating layer coated on the cladding.

In one embodiment, the proximal end of the optical fiber has a length of 3mm to 1000mm; and/or the number of the groups of groups,

the fiber core and the cladding are made of light-transmitting materials, and the refractive indexes of the fiber core and the cladding are different; and/or the number of the groups of groups,

the sleeve is the same material as the cladding.

In one embodiment, the sleeve is provided with a through hole for the optical fiber bundle to pass through, the through hole comprises a first hole section and a second hole section which are sequentially distributed along the axial direction, and the aperture of the first hole section is larger than that of the second hole section; the outer diameter of the sleeve is the same as the aperture of the second hole section; the proximal end of the cannula is positioned within the first bore section and the distal end of the cannula is positioned within the second bore section.

In one embodiment, the axial length of the sleeve in the second bore section is less than the axial length of the second bore section.

In one embodiment, the proximal end face of the ferrule, the proximal end face of the fiber optic bundle, and the proximal end face of the sleeve are flush; and/or the number of the groups of groups,

the sleeve is made of a light-transmitting material.

In one embodiment, the distal ends of the optical fibers are fused and arranged in a honeycomb configuration.

In one embodiment, the catheter body comprises a first outer tube, a connecting tube and a second outer tube which are sequentially connected, wherein the proximal end of the first outer tube is connected with the sleeve;

the catheter body has a channel therein, wherein the channel extends from a proximal end of the connecting tube to a distal end of the second outer tube.

In one embodiment, the output portion further includes an inner ring layer and an outer ring layer sequentially sleeved from inside to outside, the outer ring layer is disposed at the distal end of the second outer tube, and proximal ends of all the plurality of optical fibers are disposed between the inner ring layer and the outer ring layer.

In one embodiment, at least one layer of the optical fibers is arranged between the inner ring layer and the outer ring layer, and distal ends of each layer of the optical fibers are distributed in sequence along the circumferential direction of the output part.

In one embodiment, the innermost optical fiber is bonded to the inner annular layer and the outermost optical fiber is bonded to the outer annular layer.

A laser ablation system comprising a laser and a laser ablation catheter according to any preceding claim, the laser being configured to generate and transmit laser light to a proximal end face of a fiber optic bundle of the laser ablation catheter;

the laser output end of the laser is provided with a connecting flange, the proximal end of the sleeve of the laser ablation catheter is connected with the connecting flange, and the outer contour of the proximal end of the sleeve is matched with the outer contour of the connecting flange.

According to the laser ablation catheter and the laser ablation system, the sleeve arranged on the proximal end of the catheter main body can be connected with the outermost optical fibers of the optical fiber bundle in a hot-pressing welding mode, the sleeve can shrink inwards when the sleeve is heated and extruded, the optical fibers penetrating through the sleeve can be synchronously extruded, the cross section of the proximal end of the optical fibers can be changed into a hexagon from a round shape after the proximal end of the optical fibers is extruded by the sleeve, so that the sleeve can be welded with the outermost optical fibers in the optical fiber bundle into a whole and adjacent optical fibers in the optical fiber bundle into a whole, glue-free fixation of the proximal end of the optical fibers on the catheter main body is realized, and the problems that the proximal end of the existing optical fibers is extruded and damaged by the aid of adhesive fixation and the energy transmission efficiency of the whole laser ablation catheter is reduced can be solved. In the whole hot-press welding process, the pressure of the sleeve on the optical fiber bundle is controllable, so that the extrusion damage to the optical fiber can be avoided.

Drawings

FIG. 1 is a schematic view of a laser ablation catheter according to an embodiment of the present utility model;

FIG. 2 is a cross-sectional view of the laser ablation catheter provided in FIG. 1 in the direction A-A;

FIG. 3 is a side view of the laser ablation catheter provided in FIG. 1 from the proximal end;

FIG. 4 is a schematic diagram illustrating the cooperation of a laser ablation catheter with an external laser according to an embodiment of the present utility model;

FIG. 5 is a schematic illustration of an assembly between a fiber optic bundle and a ferrule prior to thermocompression bonding in accordance with one embodiment of the present utility model;

FIG. 6 is a schematic diagram illustrating a process of deforming an optical fiber bundle by itself under hot extrusion of a ferrule according to an embodiment of the present utility model;

FIG. 7 is a schematic perspective view of a proximal end of an optical fiber according to an embodiment of the present utility model;

FIG. 8 is a schematic perspective view of the distal and middle portions of an optical fiber according to an embodiment of the present utility model;

FIG. 9 is a longitudinal cross-sectional view of a sleeve according to one embodiment of the present utility model;

FIG. 10 is a longitudinal cross-sectional view of a connecting tube according to an embodiment of the present utility model after the connecting tube is mated with a first outer tube and a second outer tube;

FIG. 11 is a side view of a laser ablation catheter according to an embodiment of the utility model from a distal end;

FIG. 12 is a side view of a laser ablation catheter according to another embodiment of the utility model from a distal end;

FIG. 13 is a schematic view of the interior of a distal end of a laser ablation catheter according to an embodiment of the utility model;

fig. 14 is an assembly schematic diagram of a laser ablation catheter and a laser according to an embodiment of the utility model.

Detailed Description

In order that the above objects, features and advantages of the utility model will be readily understood, a more particular description of the utility model will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present utility model. The present utility model may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit of the utility model, whereby the utility model is not limited to the specific embodiments disclosed below.

In the description of the present utility model, it should be understood that, if any, these terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc., are used herein with respect to the orientation or positional relationship shown in the drawings, these terms refer to the orientation or positional relationship for convenience of description and simplicity of description only, and do not indicate or imply that the apparatus or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore should not be construed as limiting the utility model.

Furthermore, the terms "first," "second," and the like, if any, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In the description of the present utility model, the terms "plurality" and "a plurality" if any, mean at least two, such as two, three, etc., unless specifically defined otherwise.

In the present utility model, unless explicitly stated and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly. For example, the two parts can be fixedly connected, detachably connected or integrated; can be mechanically or electrically connected; either directly or indirectly, through intermediaries, or both, may be in communication with each other or in interaction with each other, unless expressly defined otherwise. The specific meaning of the above terms in the present utility model can be understood by those of ordinary skill in the art according to the specific circumstances.

In the present utility model, unless expressly stated or limited otherwise, the meaning of a first feature being "on" or "off" a second feature, and the like, is that the first and second features are either in direct contact or in indirect contact through an intervening medium. Moreover, a first feature being "above," "over" and "on" a second feature may be a first feature being directly above or obliquely above the second feature, or simply indicating that the first feature is level higher than the second feature. The first feature being "under", "below" and "beneath" the second feature may be the first feature being directly under or obliquely below the second feature, or simply indicating that the first feature is less level than the second feature.

It will be understood that if an element is referred to as being "fixed" or "disposed" on another element, it can be directly on the other element or intervening elements may also be present. If an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like as used herein, if any, are for descriptive purposes only and do not represent a unique embodiment.

It should be noted that "distal" and "proximal" are used throughout to refer to a relative positional relationship, where "distal" of a component refers to an end of the component that is first introduced into a patient and/or is farther from an operator than the other end during normal operation, and "proximal" refers to an end that is later introduced into the patient and/or is closer to the operator than the other end.

Referring to fig. 1, an embodiment of the present utility model provides a laser ablation catheter 10, where the laser ablation catheter 10 includes a catheter body 100, a sleeve 300, a sleeve 220, and a fiber optic bundle 300 (not shown in fig. 1), and the fiber optic bundle 300 is disposed in the catheter body 100 through the sleeve 210, and an output portion 400 is formed at a distal end of the catheter body 100; further, referring to fig. 2 and 3, a sleeve 210 is provided at the proximal end of the catheter body 100, a ferrule 220 is provided in the sleeve 210, the ferrule 220 is connected to the outermost optical fiber 310 of the optical fiber bundle 300 by means of heat press fusion, and adjacent optical fibers 310 in the optical fiber bundle 300 are fusion-bonded by means of heat press of the ferrule 220.

The laser ablation catheter 10 can be applied to cardiovascular diseases, referring to fig. 4, the laser ablation catheter 10 can transmit laser energy with short wavelength, short pulse width and high peak power generated by the external laser 20 to a target site in a patient body, and ablate the target site to achieve a therapeutic effect.

Referring to fig. 5 and 6, in the laser ablation catheter 10, the sleeve 220 disposed on the proximal end of the catheter body 100 may be connected to the outermost optical fiber 310 of the optical fiber bundle 300 by means of thermal compression welding, wherein the sleeve 220 is shrunk inwards when the sleeve 220 is heated and pressed, the optical fiber 310 passing through the sleeve 220 is synchronously pressed, the proximal end of the optical fiber 310 may be changed from a circular shape to a hexagonal shape after being pressed by the sleeve 220, i.e. a honeycomb shape is formed, so that the sleeve 220 may be welded together with the outermost optical fiber 310 in the optical fiber bundle 300 and adjacent optical fibers 310 in the optical fiber bundle 300 may be welded together, thereby realizing the glue-free fixation of the proximal end of the optical fiber 310 on the catheter body 100, and solving the problems of self-extrusion damage and reduced energy transmission efficiency of the entire laser ablation catheter 10 caused by the fixation of the proximal end of the optical fiber 310. It should be noted that, during the whole thermocompression bonding process, the pressure of the ferrule 220 on the optical fiber bundle 300 is controllable, so that the optical fiber 310 is prevented from being damaged by extrusion.

In some embodiments of the present utility model, the distal ends of the optical fibers 310 are fused to form a honeycomb arrangement as shown in fig. 3 and 6, and the honeycomb structure provides sufficient fusion between adjacent optical fibers 310 to ensure the strength of the connection between the optical fibers 310.

In some embodiments of this application, referring to FIG. 7, the proximal end of each optical fiber 310 includes a core 310a and a cladding 310b surrounding the core 310a, the core 310a and the cladding 310b are both light transmissive and the refractive index of the core 310a and the cladding 310b are different, and the ferrule 220 is fused to the cladding 310b of the outermost optical fiber 310. In order to better show the proximal structure of the optical fiber 310, the optical fiber 310 shown in fig. 7 has a section of cladding 310b stripped off at its proximal end. Referring to fig. 8, the distal end and the middle portion of the optical fiber 310 include a core 310a, a cladding 310b, and a coating layer 310c sequentially disposed from outside, wherein the core 310a and the cladding 310b are made of at least one of fused silica, optical glass, and plastic, and the coating layer 310c is made of a heat-resistant polymer material such as polyimide or polytetrafluoroethylene. To better illustrate the middle and distal structure of the optical fiber 310, the optical fiber 310 shown in fig. 8 has a section of cladding 310b and a section of coating layer 310c stripped off at its proximal end, wherein the stripped length of the coating layer 310c is greater than the stripped length of the cladding layer 310b, so that the cladding layer 310b is exposed to the outside of the coating layer 310 c.

The optical fiber 310 has a smaller number of coating layers 310c at the proximal end than at the distal end and the middle, and if the coating layers 310c remain at the proximal end of the optical fiber 310, the cladding layer 310b with a high melting point (up to 1000 ℃) is less deformed by extrusion when the preset heating temperature is close to the melting point of the coating layers 310c (100 ℃ -200 ℃), which is not beneficial to the fusion between the ferrule 220 and the optical fiber 310 and between the adjacent optical fibers 310; when the preset heating temperature is close to the melting point of the cladding 310b, the coating layer 310c having a low melting point is melted between the adjacent optical fibers 310, which affects the energy transmission efficiency of the entire laser ablation catheter 10.

The middle portion of the optical fiber 310 refers to a portion between the proximal end and the distal end of the optical fiber 310.

Further, in some embodiments of this application, the proximal end of the optical fiber 310 has a length of 3mm to 1000mm, i.e., the optical fiber 310 has a length of 3 to 1000mm in which the coating layer 310c is not provided. This arrangement ensures that the optical fiber 310 has a sufficient length to be operatively coupled to the ferrule 220. Wherein the length of the optical fiber 310 in which the coating layer 310c is not provided may be greater than or equal to the axial length of the ferrule 220. The specific length of the proximal end of the optical fiber 310 may be selected according to various circumstances, and may be, for example, 3mm, 10mm, 50mm, 100mm, 300m, 500mm, 700mm, 900mm, 1000mm, etc.

In some embodiments of the present utility model, the sleeve 220 is made of a light-transmitting material. When the laser spot generated by the laser irradiates the proximal end face of the ferrule 220 due to the larger diameter, the ferrule 220 made of transparent material has a certain bearing capacity for high-energy laser, so that no local hot spot is generated, and the ferrule is not expanded to avoid extrusion damage to the optical fiber bundle 300.

Alternatively, the melting point of ferrule 220 may be close to the melting point of cladding 310b of optical fiber 310. Thus, the ferrule 220 can be firmly fused with the optical fibers 310 and the adjacent optical fibers 310 at a predetermined heating temperature. The material of the ferrule 220 may be the same as or different from the material of the cladding 310b of the optical fiber 310, for example, the ferrule 220 may be fused silica.

Referring to fig. 9, in some embodiments of the present utility model, the sleeve 210 has a through hole 210a for the optical fiber 310 to pass through, and the through hole 210a includes a first hole section 210a1 and a second hole section 210a2 sequentially distributed along an axial direction, where a hole diameter of the first hole section 210a1 is larger than a hole diameter of the second hole section 210a 2; referring to fig. 2, the outer diameter of sleeve 220 is the same as the bore diameter of second bore section 210a 2; the proximal end of sleeve 220 is positioned in first bore section 210a1 and the distal end of sleeve 220 is positioned in second bore section 210a 2. When the laser light generated by the laser 20 irradiates the proximal end surface of the sleeve 210, the proximal end surface of the sleeve 210 is expanded by heat, the sleeve 210 can be avoided by the first deformation gap Q formed by the sleeve 220 and the hole wall of the first hole section 210a1, and the sleeve 220 can be prevented from being extruded by the sleeve 210, so that the risk of the optical fiber 310 in the sleeve 220 being damaged by extrusion can be reduced. The sleeve 210 may be made of a hard material, such as a metal material, so as to function as the protection sleeve 220 and the optical fiber 310.

Further, referring to fig. 2, in some embodiments of the utility model, the axial length of sleeve 220 in second bore section 210a2 is less than the axial length of second bore section 210a 2. By such arrangement, the length of the sleeve 220 can be reduced, the processing cost of the laser ablation catheter 10 and the assembling difficulty of the sleeve 220 on the sleeve 210 can be reduced, and a second deformation gap Q2 can be formed between the optical fiber 310 and the inner wall of the sleeve 210, and the second deformation gap Q2 can prevent the optical fiber 310 from being extruded and damaged in the sleeve 210. The sleeve 220 may be fixed to the sleeve 210 by means of adhesion or the like.

Referring to fig. 2, in some embodiments of the utility model, the proximal end face of ferrule 220, the proximal end face of fiber optic bundle 300, is flush with the proximal end face of sleeve 210. By such arrangement, the suspension of the optical fiber bundle 300 from the proximal end of the sleeve 210 can be avoided, the variation of the coupling efficiency of the optical fiber bundle 300 to the laser can be avoided, and the transmission efficiency of the laser ablation catheter 10 can be improved, so that the treatment effect of the laser ablation catheter 10 can be ensured.

Referring to fig. 1, in some embodiments of the present utility model, the catheter body 100 includes a first outer tube 110, a connection tube 120, and a second outer tube 130 sequentially connected, wherein a proximal end of the first outer tube 110 is connected to a sleeve 210; referring to fig. 10, the catheter body 100 has a channel 100a therein, wherein the channel 100a extends from the proximal end of the connecting tube 120 to the distal end of the second outer tube 130. The channel 100a may be used as a channel for the passage of a guide wire or other interventional instrument, as well as a channel for instillation of saline or aspiration of impurities.

With respect to the number of channels 100a, embodiments of the present utility model are not particularly limited as long as the surgical requirements are met. When the number of the channels 100a is plural, the plural channels 100a are arranged at intervals. Illustratively, the catheter body 100 shown in FIG. 11 has 1 channel 100a disposed thereon; further example the catheter body 100 shown in fig. 12 is provided with 2 channels 100a.

Wherein referring to fig. 10-13, the laser ablation catheter 10 may further comprise an operating tube 500, the operating tube 500 being disposed within the connecting tube 120 and extending into the working section outer tube 130, the lumen of the operating tube 500 constituting the channel 100a of the catheter body 100.

The operation pipe 500 may be made of a polymer material such as polytetrafluoroethylene, and the operation pipe 500 may be provided in the connection pipe 120 by means of adhesion or the like.

The connecting tube 120 may have a Y-shape, and includes a distal junction portion and two proximal branch portions, wherein the proximal end of the operating tube 500 and the proximal end of the fiber optic bundle 300 are separated from each other at the branching portion of the connecting tube 120 and extend into the different proximal branch portions.

The connection pipe 120 may be connected to the first outer pipe 110 and the second outer pipe 130 by bonding or the like.

Referring to fig. 11 to 13, in some embodiments of the present utility model, the output part 400 further includes an inner ring layer 410 and an outer ring layer 420 sleeved in sequence from inside to outside, the outer ring layer 420 is disposed on the distal end of the second outer tube 130, the distal ends of all the optical fibers 310 are disposed between the inner ring layer 410 and the outer ring layer 420, and the distal ends of the channels 100a further extend into the inner ring layer 410. As an example, the inner annular layer 410 is disposed over the exterior of the distal end of the handle tube 500. When processing the laser ablation catheter 10, after the distal end of the tube 500 is extended from the second outer tube 130, the inner ring layer 410 is disposed on the distal end of the tube 500, then the distal ends of all the optical fibers 310 are disposed on the outer wall of the inner ring layer 410, and then the outer ring layer 420 is sleeved on the distal outer portion of the optical fiber bundle 300 and adjacent to the second outer tube 130. In this manner, the distal end of the optical fiber 310 is conveniently secured.

The outer ring layer 420 may be made of a developing material or have a developing layer on an outer surface. The material of the outer ring layer 420 and the material of the developing layer may be metal materials such as stainless steel, platinum iridium alloy, etc. So configured, the outer ring layer 420 may function as a positioning and tracking function. The outer annular layer 420 may be bonded to the optical fiber 310, the second outer tube 130, etc.

The inner ring layer 410 may be made of metal (e.g. stainless steel) or rigid plastic (e.g. polyether ether ketone), and the inner ring layer 410 may be connected to the optical fiber 310 and the operation tube by bonding or the like.

Referring to fig. 11 and 12, at least one layer of optical fibers 310 is disposed between the inner ring layer 410 and the outer ring layer 420, and distal ends of each group of optical fibers 310 are sequentially distributed along the circumferential direction of the output section 400. The optical fiber 310 may be provided with 1 layer (see fig. 11) or a plurality of layers, such as 2 layers shown in fig. 12, between the inner annular layer 410 and the outer annular layer 420. Regarding the number of layers of the optical fiber 310, the embodiment of the present utility model is not particularly limited as long as the ablation efficiency of the laser ablation catheter 10 can be ensured.

The laser ablation catheter 10 as described above, in which the proximal end of the optical fiber bundle 300 is fixed to the catheter body 100 by means of thermo-compression welding, the energy transmission efficiency can reach 65%, which is higher than 45.59% of the standard in the prior art, wherein the high energy transmission efficiency can reduce the energy requirement of the proximal end of the catheter under the condition that the energy requirement of the distal end of the catheter is unchanged, so that the requirement on the laser 20 can be reduced, the stability of the laser can be improved, the cost can be reduced, and the forward benefit can be generated for the whole laser ablation system.

Still further embodiments of the present utility model provide a method of machining a laser ablation catheter 10 as set forth in any one of the preceding claims, the method comprising:

step S100, providing a plurality of optical fibers 310, removing coating layers 310c at the proximal ends of all the optical fibers 310, and aligning the proximal end faces of all the optical fibers 310;

step S200, providing a sleeve 220, inserting the proximal ends of all the optical fibers 310 into the sleeve 220, and then heating and pressurizing the sleeve 220 to weld the sleeve 220 with the outermost optical fibers 310 and weld adjacent optical fibers 310;

step S300, providing the sleeve 210 and the catheter body 100, disposing the sleeve 220 within the sleeve 210, connecting the sleeve 210 with the proximal end of the catheter body 100, and disposing the distal, middle portion of the fiber optic bundle 300 within the catheter body 100.

In the above-mentioned processing method of the laser ablation catheter 10, the sleeve 220 is sleeved on the proximal end of the optical fiber bundle 300 by adopting the hot-pressing welding method, wherein when the sleeve 220 is heated and extruded, the sleeve 220 is shrunk inwards, and the optical fibers 310 penetrating through the sleeve 220 are synchronously extruded, and the cross-sectional shape of the proximal end of the optical fiber 310 is changed from a circular shape to a hexagonal shape after being extruded by the sleeve 220, so that the sleeve 220 can be welded with the optical fibers 310 at the outermost layer of the optical fiber bundle 300 into a whole and adjacent optical fibers 310 in the optical fiber bundle 300 are welded into a whole, thus realizing the glue-free fixation of the proximal end of the optical fiber 310 on the catheter main body 100, and solving the problems that the proximal end of the existing optical fiber 310 is extruded and damaged by itself and the energy transmission efficiency of the whole laser ablation catheter 10 is reduced due to the adoption of the adhesive fixation. It should be noted that, during the whole process of thermocompression bonding, the pressure of the ferrule 220 on the optical fiber bundle 300 is controllable, so that the optical fiber 310 is prevented from being damaged by extrusion.

For step S200, after the thermo-compression welding process is completed, the optical fiber bundle 300 and the sleeve 220 are cooled to normal temperature, and then the proximal end face of the optical fiber bundle 300 is ground and polished to make the surface smooth and bright, and finally cleaned to remove grinding and polishing liquid.

For step S300, the sleeve 220 may be disposed in the sleeve 210, and then the sleeve 210 may be sequentially connected to the proximal end of the catheter body 100, and the distal end and the middle of the optical fiber bundle 300 may be disposed in the catheter body 100; alternatively, the tube may be connected to the proximal end of the catheter body 100, and then the distal end and the middle of the optical fiber bundle 300 may be sequentially disposed in the catheter body 100, and the sleeve 220 may be disposed in the sleeve 210; the distal end and the middle portion of the optical fiber bundle 300 may be disposed in the catheter body 100, and then the barrel may be sequentially connected to the proximal end of the catheter body 100, and the sleeve 220 may be disposed in the sleeve 210.

Referring to fig. 4, still further embodiments of the present utility model provide a laser ablation system, the laser ablation catheter 10 system including a laser 20 and the laser ablation catheter 10 of any of the above, the laser 20 being configured to generate and transmit laser light to a proximal end of an optical fiber bundle 300 of the laser ablation catheter 10.

As an example, referring to fig. 4, the laser 20 may include a laser generating module 20a for generating laser light and a coupling module 20b for coupling the laser light and transmitting the coupled laser light to the proximal end of the fiber optic bundle 300.

In the laser ablation system, the sleeve 220 disposed on the proximal end of the catheter body 100 may be connected to the outermost optical fiber 310 of the optical fiber bundle 300 by means of thermal compression, wherein the sleeve 220 is shrunk inwards when the sleeve 220 is heated and pressed, and the optical fiber 310 penetrating through the sleeve 220 is also pressed together, and the cross-sectional shape of the proximal end of the optical fiber 310 is changed from a circular shape to a hexagonal shape after being pressed by the sleeve 220, so that the sleeve 220 and the outermost optical fiber 310 in the optical fiber bundle 300 are fused together, and adjacent optical fibers 310 in the optical fiber bundle 300 are fused together, thereby realizing the glue-free fixation of the proximal end of the optical fiber 310 on the catheter body 100, and solving the problems that the proximal end of the existing optical fiber 310 is damaged by self-extrusion due to the adoption of adhesive fixation and the energy transmission efficiency of the whole laser ablation catheter 10 is reduced. It should be noted that, during the whole process of thermocompression bonding, the pressure of the ferrule 220 on the optical fiber bundle 300 is controllable, so that the optical fiber 310 is prevented from being damaged by extrusion.

Referring to fig. 14, in some embodiments of this application, the laser output end of the laser ablation catheter 10 is provided with a connection flange 20c, and the proximal end of the sleeve 210 of the laser ablation catheter 10 is connected to the connection flange 20c, wherein the proximal profile of the sleeve 210 is adapted to the profile of the connection flange 20 c. It should be noted that, the matching of the proximal profile of the sleeve 210 with the profile of the connection flange 20c means that the shape and the size of the proximal cross section of the sleeve 220 are matched with those of the connection flange 20c, and for example, the proximal cross section of the sleeve 220 and the connection flange 20c are both circular and have the same outer diameter. Such a configuration of the proximal end of the sleeve 210 may enable the sleeve 210 to be adapted to the attachment flange 20c of a conventional laser 20 without customization, with a strong general shape. The bold black arrow in fig. 14 represents the fitting direction of the laser ablation catheter 10.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples illustrate only a few embodiments of the utility model, which are described in detail and are not to be construed as limiting the scope of the claims. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the utility model, which are all within the scope of the utility model. Accordingly, the scope of protection of the present utility model is to be determined by the appended claims.

Claims (12)

1. A laser ablation catheter, comprising: a catheter body (100), a sleeve (210), a ferrule (220) and a fiber optic bundle (300);

the optical fiber bundle (300) is arranged in the catheter main body (100), and an output part (400) is formed at the distal end of the catheter main body (100);

the proximal end of the catheter main body (100) is provided with the sleeve (210), the sleeve (220) is arranged in the sleeve (210), the sleeve (220) is connected with the outermost optical fibers (310) of the optical fiber bundle (300) through a hot press welding mode, and adjacent optical fibers (310) in the optical fiber bundle (300) are welded through the hot press of the sleeve (220).

2. The laser ablation catheter of claim 1, wherein the proximal end of each optical fiber (310) includes a core (310 a) and a cladding (310 b) over the core (310 a), the sleeve (220) being fused to the cladding (310 b) of the outermost optical fiber (310); the distal and middle portions of each optical fiber (310) include a core (310 a), a cladding (310 b) over the core (310 a), and a coating layer (310 c) over the cladding (310 b).

3. The laser ablation catheter of claim 2, wherein the proximal length of the optical fiber (310) is 3mm to 1000mm; and/or the number of the groups of groups,

the materials used for the fiber core (310 a) and the cladding (310 b) are light-transmitting materials, and the refractive indexes of the fiber core (310 a) and the cladding (310 b) are different; and/or the number of the groups of groups,

the sleeve is of the same material as the cladding (310 b).

4. The laser ablation catheter according to claim 1, wherein the sleeve (210) has a through hole (210 a) for passing the fiber optic bundle (300), the through hole (210 a) comprising a first hole section (210 a 1) and a second hole section (210 a 2) distributed in sequence along an axial direction, the first hole section (210 a 1) having a larger pore diameter than the second hole section (210 a 2); -the outer diameter of the sleeve (220) is the same as the bore diameter of the second bore section (210 a 2); the proximal end of the cannula (220) is positioned to the first bore section (210 a 1), and the distal end of the cannula (220) is positioned within the second bore section (210 a 2).

5. The laser ablation catheter of claim 4, wherein a length of the sleeve (220) in the second bore section (210 a 2) is less than an axial length of the second bore section (210 a 2).

6. The laser ablation catheter of claim 1, wherein a proximal end face of the sleeve (220), a proximal end face of the fiber optic bundle (300), is flush with a proximal end face of the sleeve (210); and/or the number of the groups of groups,

the sleeve (220) is made of a light-transmitting material.

7. The laser ablation catheter of claim 1, wherein the distal ends of the optical fibers (310) are fused in a honeycomb arrangement.

8. The laser ablation catheter according to any one of claims 1 to 7, wherein the catheter body (100) comprises a first outer tube (110), a connecting tube (120) and a second outer tube (130) joined in sequence, a proximal end of the first outer tube (110) being connected to the sleeve (210);

the catheter body (100) has a channel (100 a) therein, the channel (100 a) extending from a proximal end of the connecting tube (120) to a distal end of the second outer tube (130).

9. The laser ablation catheter (10) of claim 8, wherein the output section (400) further comprises an inner ring layer (410) and an outer ring layer (420) sleeved in sequence from inside to outside, the outer ring layer (420) being disposed on the distal end of the second outer tube (130), the distal ends of all the optical fibers (310) being disposed between the inner ring layer (410) and the outer ring layer (420).

10. The laser ablation catheter according to claim 9, wherein at least one layer of the optical fibers (310) is arranged between the inner ring layer (410) and the outer ring layer (420), the distal ends of each layer of the optical fibers (310) being distributed in sequence along the circumference of the output section (400).

11. The laser ablation catheter according to claim 9, wherein the innermost optical fiber (310) is bonded to the inner annular layer (410) and the outermost optical fiber (310) is bonded to the outer annular layer (420).

12. A laser ablation system comprising a laser (20) and a laser ablation catheter (10) according to any of claims 1 to 11, the laser (20) being adapted to generate and transmit laser light to a proximal end face of an optical fiber bundle (300) of the laser ablation catheter (10);

the laser output end of the laser (20) is provided with a connecting flange (20 c), the proximal end of a sleeve (210) of the laser ablation catheter (10) is connected with the connecting flange (20 c), and the outer contour of the proximal end of the sleeve (210) is matched with the outer contour of the connecting flange (20 c).