Catheter structure and laser treatment equipment

Abstract

The invention relates to a catheter structure and laser treatment equipment. The catheter structure comprises a tube assembly which comprises an inner tube and an outer tube arranged on the outer side of the inner tube in a sleeving mode, and a containing space is defined by the inner tube and the outer tube; the ablation tube is arranged in the containing space in the axial direction, the ablation tube comprises a quartz tube and a hollow-core anti-resonance optical fiber, and the far end of the hollow-core anti-resonance optical fiber is arranged in the quartz tube; wherein the near end of the hollow-core anti-resonance optical fiber is used for being connected with the laser, and the laser is used for conveying laser to the hollow-core anti-resonance optical fiber and outputting the laser through the quartz tube, so that the far end of the catheter structure outputs energy. Thus, the hollow-core anti-resonance optical fiber is adopted to transmit laser, the coupling efficiency of the laser is improved, the transmission efficiency of the laser is improved, meanwhile, the overall size can be reduced, the passing ability is improved, and the far end of the catheter structure can provide three ablation modes of independent laser, independent shock wave and laser and shock wave combination. The clinical treatment efficiency and the instrument reliability are obviously improved.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a catheter structure and laser therapy device. Background Technology

[0002] Cardiovascular diseases (such as coronary artery disease and atherosclerosis) are among the major health threats worldwide. Atherosclerosis can lead to narrowing or blockage of blood vessels, causing serious consequences such as myocardial infarction and stroke. Traditional treatments include drug therapy, open surgery, and interventional procedures (such as balloon angioplasty and stent implantation). However, for complex cases such as severe calcified lesions, chronic total occlusion, or in-stent restenosis, traditional methods have limitations, such as difficulty in balloon insertion and incomplete stent expansion.

[0003] In recent years, shockwave balloon technology has emerged as an innovative treatment method, offering a new solution for calcified lesions. This technology combines the characteristics of traditional balloon angioplasty with acoustic pressure wave (shockwave) therapy. By generating localized high-pressure sound waves within the balloon, it selectively targets and breaks down calcified plaques within the blood vessel wall, without damaging surrounding soft tissue. The current clinical consensus recommends first using a laser catheter to deliver energy for laser ablation to open the pathway, followed by further treatment with rotational atherectomy catheters or shockwave balloons to allow for successful stent implantation and complete apposition to the vessel wall, achieving the desired therapeutic effect.

[0004] Laser catheters based on quartz fiber bundles generally employ a structure design with multiple fine-core optical fibers arranged in parallel, where the core diameter of a single fiber is typically limited to within 200 μm to ensure the catheter's flexible passage within blood vessels. However, this structure has significant drawbacks when transmitting high-peak-power pulsed lasers: First, the fiber coupling end faces are prone to damage under high-energy-density laser irradiation, resulting in a limited single-fiber transmission threshold. To achieve a clinically effective tissue ablation energy threshold, the number of fibers must be multiplied, which not only significantly increases the complexity of catheter manufacturing but also directly drives up the cost of medical consumables. Second, due to coupling losses caused by differences in refractive index between fiber cores and spatial arrangement gaps, the overall optical transmission efficiency of multi-core fiber bundles is generally below 50%, forcing laser treatment systems to be equipped with high-power laser generators, increasing equipment purchase costs and posing challenges to energy control precision in clinical operations.

[0005] Similarly, shockwave balloon technology also faces key limitations: because the shock wave attenuates rapidly along the axial direction with the propagation distance, its effective range is limited to the lesion area that the balloon can directly contact. For severely stenotic or completely occluded vascular segments, if the balloon cannot pass through, the shock wave energy is difficult to effectively deliver to the target lesion site, which greatly limits the applicability of this technology.

[0006] For complex, high-resistance lesions, the lesion composition may include soft plaques such as thrombi and fibrotic lesions, as well as hard calcified plaques. Opening and treatment requires a combination of multiple instruments, and the use of multiple instruments prolongs the operation time, introduces new risks, and increases the burden of contrast agents and radiation. Therefore, how to overcome the bottleneck of single-fiber energy transmission while ensuring catheter permeability and simultaneously improving light energy utilization efficiency has become a pressing technical challenge in this field. Similarly, developing a shockwave energy delivery system that can directly contact the lesion axially is also an important direction for innovation in vascular interventional devices. Summary of the Invention

[0007] Based on this, this application provides a catheter structure and a laser treatment device that can improve the coupling efficiency and transmission efficiency of the laser, reduce the overall size of the catheter structure, and improve the passability. At the same time, it can also provide three ablation modes: laser alone, shock wave alone, and laser and shock wave combined, which significantly improves clinical treatment efficiency and device reliability.

[0008] A catheter structure comprising:

[0009] A pipe assembly includes an inner pipe and an outer pipe sleeved outside the inner pipe, the inner pipe and the outer pipe forming a receiving space; and

[0010] An ablation tube is disposed axially in the receiving space. The ablation tube includes a quartz tube and a hollow anti-resonant optical fiber, with the distal end of the hollow anti-resonant optical fiber disposed in the quartz tube.

[0011] The near end of the hollow anti-resonant optical fiber is used to connect to a laser, which is used to deliver laser light to the hollow anti-resonant optical fiber and output it through the quartz tube, so that the far end of the conduit structure outputs energy.

[0012] In one embodiment of this application, there is a preset distance L between the distal end of the hollow anti-resonant optical fiber and the bottom wall of the quartz tube, and the preset distance L is proportional to the ablation area of ​​the conduit structure.

[0013] In one embodiment of this application, an adhesive is used to fill the space between the outer wall of the inner tube, the inner wall of the outer tube, and the distal end of the outer wall of the quartz tube.

[0014] And / or, the inner wall of the quartz tube is provided with adhesive for bonding the hollow anti-resonant optical fiber.

[0015] In one embodiment of this application, the distal end of the conduit structure is capable of outputting a laser.

[0016] In one embodiment of this application, the ablation tube further includes a hollow cavity located at the distal end of the receiving space and the quartz tube. The laser is emitted through the hollow anti-resonant optical fiber, the quartz tube, and the cavity, so that the distal end of the conduit structure outputs laser light.

[0017] Alternatively, the distal end of the quartz tube is coplanar with the distal end of the tube assembly, and the laser is emitted through the hollow anti-resonant optical fiber and the quartz tube, so that the distal end of the conduit structure outputs laser light.

[0018] In one embodiment of this application, the catheter structure includes at least two ablation tubes, which are spaced apart circumferentially along the inner tube, and are used to output laser light from the distal end of the catheter structure.

[0019] In one embodiment of this application, the distal end of the conduit structure is capable of outputting a shock wave.

[0020] In one embodiment of this application, the ablation tube further includes a receiving cavity located at the distal end of the receiving space and the quartz tube. The receiving cavity is filled with a filling agent. A laser is injected into the receiving cavity through the hollow anti-resonant optical fiber and the quartz tube, causing a pressure change in the filling agent in the receiving cavity and forming a shock wave, so that the distal end of the conduit structure outputs a shock wave.

[0021] In one embodiment of this application, the catheter structure includes at least two ablation tubes, which are spaced apart circumferentially along the inner tube, and are used to output shock waves from the distal end of the catheter structure.

[0022] In one embodiment of this application, the filling agent is a liquid that absorbs laser energy, and includes at least physiological saline, contrast agent, or a mixed solution of physiological saline and contrast agent;

[0023] And / or, the receiving cavity is filled with the filling agent;

[0024] And / or, the conduit structure further includes a fluid inlet tube, the distal end of which extends into the receiving space and communicates with the receiving cavity for injecting a filling agent into the receiving cavity.

[0025] In one embodiment of this application, the distal end of the conduit structure is capable of outputting laser and shock wave.

[0026] In one embodiment of this application, the catheter structure includes at least two ablation tubes, which are spaced apart circumferentially along the inner tube. Some of the ablation tubes are used to output laser at the distal end of the catheter structure, and some of the ablation tubes are used to output shock wave at the distal end of the catheter structure.

[0027] In one embodiment of this application, the conduit structure further includes an adapter and a quartz optical fiber. The adapter is disposed at the proximal end of the hollow anti-resonant optical fiber and connected to the distal end of the quartz optical fiber. The proximal end of the quartz optical fiber is used to connect to the laser.

[0028] And / or, the catheter structure further includes a radiopaque element disposed on the outer wall of the distal end of the outer tube;

[0029] And / or, the outer wall of the outer tube near the distal end is further provided with a guide wire port that communicates with the inner cavity of the inner tube;

[0030] And / or, the inner tube and the outer tube are made of polymer materials;

[0031] And / or, the outer diameter of the outer tube is in the range of 0.5mm to 2.5mm, and the axial length of the outer tube is in the range of 1000mm to 3000mm.

[0032] A laser therapy device includes a laser and a catheter structure as described in any of the above-mentioned technical features;

[0033] The laser is connected to the proximal end of the duct structure and is used to emit laser light into the duct structure.

[0034] By adopting the above technical solution, this application has at least the following technical effects:

[0035] The catheter structure and laser treatment device of this application include an ablation tube axially disposed within a space enclosed by an inner tube and an outer tube. A quartz tube is located at the distal end of a hollow anti-resonant optical fiber within the ablation tube. The proximal end of the hollow anti-resonant optical fiber can be connected to a laser. The laser emitted by the laser passes through the hollow anti-resonant optical fiber and the quartz tube, enabling the distal end of the catheter structure to output energy, such as laser, shock wave, or a combination of laser and shock wave. This allows for the treatment of the lesion site using laser ablation, shock wave ablation, or a combination of laser and shock wave ablation.

[0036] Thus, the catheter structure uses a hollow anti-resonant optical fiber as the transmission structure to deliver laser to the distal quartz tube, improving laser coupling efficiency and achieving efficient and flexible transmission of high peak laser power. Simultaneously, it reduces the overall size of the catheter structure, improving its passage through blood vessels. Furthermore, after the laser is emitted through the ablation tube and quartz tube, the distal end of the catheter structure can provide three ablation modes: laser alone, shock wave alone, and a combination of laser and shock wave. This eliminates the need to replace treatment devices, significantly improving clinical treatment efficiency and device reliability, reducing treatment costs, and enhancing treatment effectiveness. Attached Figure Description

[0037] Figure 1This is a schematic diagram of the catheter structure in the first embodiment of this application.

[0038] Figure 2 for Figure 1 The ductal structure shown is viewed from the distal end.

[0039] Figure 3 for Figure 1 A partial cross-sectional view of the duct structure shown.

[0040] Figure 4 This is a schematic diagram of the catheter structure according to the second embodiment of this application.

[0041] Figure 5 for Figure 4 The ductal structure shown is viewed from the distal end.

[0042] Figure 6 for Figure 4 A partial cross-sectional view of the duct structure shown.

[0043] Figure 7 This is a schematic diagram of the catheter structure in the third embodiment of this application.

[0044] Figure 8 for Figure 7 The ductal structure shown is viewed from the distal end.

[0045] Figure 9 for Figure 7 A partial cross-sectional view of the duct structure shown.

[0046] Figure 10 for Figure 2 A partial schematic diagram of the ablation tube in the catheter structure shown.

[0047] Among them: 100, conduit structure; 110, tube assembly; 111, inner tube; 112, outer tube; 1121, guidewire port; 113, receiving space; 120, ablation tube; 121, quartz tube; 122, hollow anti-resonant optical fiber; 123, receiving cavity; 130, filling agent; 140, liquid passage tube; 150, adhesive; 160, adapter; 170, quartz optical fiber; 180, developing element. Detailed Implementation

[0048] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0049] In the description of this application, it should be understood that if terms such as "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" appear, these terms indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0050] Furthermore, where the terms "first" and "second" appear, these terms are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined with "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, where the term "multiple" appears, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0051] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0052] In this application, unless otherwise expressly specified and limited, the use of descriptions such as "above" or "below" the second feature indicates that the first and second features are in direct contact, or indirect contact via an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. Similarly, "below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0053] It should be noted that if an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. If an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. If so, the terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application are for illustrative purposes only and do not represent the only possible implementation.

[0054] Understandably, cardiovascular diseases (such as coronary heart disease and atherosclerosis) are among the major health threats worldwide. Atherosclerosis, in particular, can lead to narrowing or blockage of blood vessels, causing serious consequences such as myocardial infarction and stroke. In recent years, shockwave balloon technology has emerged as an innovative treatment method, providing a new solution for calcified lesions. This technology combines the characteristics of traditional balloon angioplasty with acoustic pressure waves (shockwaves). By generating localized high-pressure sound waves within the balloon, it selectively targets calcified plaques within the blood vessel wall, causing them to break and dissolve without damaging surrounding soft tissue. Currently, the general clinical consensus recommends first using a laser catheter to deliver energy for laser ablation to open the pathway, followed by further treatment of the calcified lesion using rotational atherectomy catheters or shockwave balloons. Ultimately, this allows for successful stent implantation and complete apposition to the vessel wall, achieving the desired therapeutic effect.

[0055] Laser catheters based on quartz fiber bundles generally employ a structure design with multiple fine-core fibers arranged in parallel, where the core diameter of a single fiber is typically limited to within 200 μm to ensure the catheter's flexible passage within the blood vessel. However, this structure has limitations when transmitting high-peak-power pulsed laser light. Similarly, shockwave balloon technology also faces critical limitations. For complex, high-resistance lesions, the lesion composition may include soft plaques such as thrombi and fibrotic lesions, as well as hard calcified plaques. Opening treatment requires a combination of multiple instruments, and the use of multiple instruments prolongs the operation time, introduces new risks, and increases the burden of contrast agents and radiation.

[0056] Therefore, overcoming the bottleneck of single-fiber energy transmission while ensuring catheter permeability and simultaneously improving light energy utilization efficiency has become a pressing technical challenge in this field. Similarly, developing a shockwave energy delivery system capable of direct axial contact with lesions is also an important direction for innovation in vascular interventional devices.

[0057] Based on this, see Figures 1 to 9 This application provides a conduit structure 100. Figure 1 This is a schematic diagram of the catheter structure 100 in the first embodiment of this application. Figure 2 for Figure 1 The duct structure 100 shown is a side view at the distal end. Figure 3 for Figure 1A partial cross-sectional view of the catheter structure 100 shown. Figure 4 This is a schematic diagram of the catheter structure 100 according to the second embodiment of this application. Figure 5 for Figure 4 The duct structure 100 shown is a side view at the distal end. Figure 6 for Figure 4 A partial cross-sectional view of the catheter structure 100 shown. Figure 7 This is a schematic diagram of the catheter structure 100 in the third embodiment of this application. Figure 8 for Figure 7 The duct structure 100 shown is a side view at the distal end. Figure 9 for Figure 7 A partial cross-sectional view of the catheter structure 100 shown.

[0058] The catheter structure 100 is used in a laser therapy device (not shown) for interventional treatment of cardiovascular diseases, thereby achieving the purpose of ablation of the lesion site. To better illustrate the specific structure of the catheter structure 100, the structure of the laser therapy device is briefly described here. The laser therapy device includes a laser (not shown) and the catheter structure 100 of this application. The laser is disposed at the proximal end of the catheter structure 100 and is used to emit a laser of a predetermined wavelength into the catheter structure 100 so that the distal end of the catheter structure 100 can output energy, such as outputting a laser, outputting a shock wave, or outputting a laser and a shock wave, to perform laser ablation, shock wave ablation, or laser ablation and shock wave ablation on the lesion site.

[0059] Of course, the laser treatment device also includes other structures such as imaging devices (not shown), which guide the insertion of the catheter structure 100 into the blood vessel so that the distal end of the catheter structure 100 accurately reaches the lesion site. It is worth noting that the focus of this application is on the catheter structure 100. Other structures of the laser treatment device are not the focus of this application and will not be described in detail here. The following text only describes the structure and working principle of the catheter structure 100.

[0060] The catheter structure 100 of this application can improve laser coupling efficiency and achieve efficient and flexible transmission of high peak laser power. Simultaneously, it can reduce the overall size of the catheter structure 100, improving its passage through blood vessels. Furthermore, the distal end of the catheter structure 100 can provide three ablation modes: laser alone, shock wave alone, and a combination of laser and shock wave, eliminating the need to replace treatment devices. This significantly improves clinical treatment efficiency and device reliability, reduces treatment costs, and enhances treatment efficacy. The specific structures of the catheter structure 100 in some embodiments are described below.

[0061] See Figures 1 to 9In one embodiment, the conduit structure 100 includes a tube assembly 110 and an ablation tube 120. The tube assembly 110 includes an inner tube 111 and an outer tube 112 sleeved outside the inner tube 111, with the inner tube 111 and outer tube 112 forming a receiving space 113. The ablation tube 120 is axially disposed within the receiving space 113 and includes a quartz tube 121 and a hollow anti-resonant optical fiber 122, the distal end of which is located within the quartz tube 121. The proximal end of the hollow anti-resonant optical fiber 122 is used to connect to a laser, which delivers laser light to the hollow anti-resonant optical fiber 122 and outputs it through the quartz tube 121, thereby enabling energy output from the distal end of the conduit structure 100.

[0062] The tubing assembly 110 is the main tubing component of the catheter structure 100, providing a channel for laser transmission and also for interventional instruments. Specifically, the tubing assembly 110 includes an inner tube 111 and an outer tube 112. The outer tube 112 is fitted over the inner tube 111, and the inner walls of the outer tube 112 and the outer tube 112 together form an annular receiving space 113. The inner tube 111 extends axially, where axial direction refers to the direction from the proximal end to the distal end of the inner tube 111. The proximal end is the end of the inner tube 111 closer to the operator (doctor), and the distal end is the end of the inner tube 111 farther from the operator (doctor). These proximal and distal ends apply to the catheter structure 100 and its components, and will not be described further below.

[0063] The ablation tube 120 is the main component of the catheter structure 100 for ablation. The ablation tube 120 is located within the receiving space 113 enclosed by the inner tube 111 and the outer tube 112, extending from the proximal end to the distal end. The proximal end of the ablation tube 120 extends beyond the outer tube 112 to connect to the laser, while the distal end of the ablation tube 120 extends towards the distal end of the outer tube 112. After the laser emits a laser of a predetermined wavelength, the laser enters the ablation tube 120 and propagates from the proximal end to the distal end, exiting through the distal end of the outer tube 112. This allows the distal end of the catheter to output energy, such as laser, shock wave, or a combination of laser and shock wave, to perform ablation treatment on the lesion.

[0064] Specifically, the ablation tube 120 includes a quartz tube 121 and a hollow anti-resonant optical fiber 122. The hollow anti-resonant optical fiber 122 extends axially, with its proximal end connected to the laser and its distal end located within the quartz tube 121. After the laser emits a laser of a predetermined wavelength, the laser enters the hollow anti-resonant optical fiber 122 and travels along it from the proximal end to the distal end, entering the quartz tube 121 and exiting through it. After exiting the quartz tube 121, the laser interacts with the tissue at the lesion site, achieving the therapeutic purpose.

[0065] Compared to the problems of low laser coupling efficiency (≤50%), poor conduit flexibility, and limited high peak power transmission associated with previous multi-core silica fiber 170 bundles, this application uses hollow-core anti-resonant fiber 122 as the laser transmission medium. Leveraging the material advantages of hollow-core anti-resonant fiber 122, the laser coupling efficiency can be significantly improved to over 90%, achieving efficient and flexible transmission of ≥10MW peak power, thereby enhancing laser transmission efficiency.

[0066] Using a hollow anti-resonant fiber 122 to transmit the laser not only simplifies the manufacturing process of the catheter structure 100 and reduces reliance on high-energy lasers, but also allows for the use of a smaller hollow anti-resonant fiber 122, thereby reducing the overall size of the catheter structure 100 and improving its transmissibility in blood vessels. Optionally, the laser can emit ultraviolet lasers, which directly break molecular bonds through photochemical effects with almost no thermal impact, making them particularly suitable for high-precision, heat-sensitive applications such as coronary arteries.

[0067] Simultaneously, after the laser energy is output through the hollow anti-resonant fiber 122 and the quartz tube 121, it can be output directly as a laser, or as a shock wave, or as a fusion of laser and shock wave output. The catheter structure 100 can provide three ablation modes: laser ablation alone, shock wave ablation alone, and combined laser and shock wave ablation. This allows for the selection of an appropriate ablation method based on the lesion location, thereby improving treatment efficiency, reducing costs, and enhancing clinical treatment efficiency and reliability.

[0068] The above embodiment uses a hollow anti-resonant optical fiber 122 as the transmission structure to deliver laser light to the distal quartz tube 121, improving laser coupling efficiency and achieving efficient and flexible transmission of high peak laser power. Simultaneously, it reduces the overall size of the catheter structure 100, improving its passage through blood vessels. Furthermore, after the laser light exits through the ablation tube 120 and quartz tube 121, the distal end of the catheter structure 100 can provide three ablation modes: laser alone, shock wave alone, and a combination of laser and shock wave. This eliminates the need to replace treatment devices, significantly improving clinical treatment efficiency and device reliability, reducing treatment costs, and enhancing treatment effectiveness.

[0069] See Figures 1 to 3 In the first embodiment of this application, the distal end of the catheter structure 100 is capable of outputting laser light. That is, the catheter structure 100 provides a separate laser ablation mode for ablation treatment of the lesion site. After the laser emits a laser of a predetermined wavelength, the laser enters the hollow anti-resonant fiber 122 and travels along the fiber from proximal to distal end into the quartz tube 121, and then exits through the quartz tube 121, so that the distal end of the catheter structure 100 directly outputs laser light. The laser can interact with the tissue at the lesion site to achieve the therapeutic purpose.

[0070] See Figure 2 , Figure 3 , Figure 8 and Figure 9 In one embodiment, the distal end of the quartz tube 121 is coplanar with the distal end of the tube assembly 110. The laser is emitted through the hollow anti-resonant optical fiber 122 and the quartz tube 121, so that the distal end of the catheter structure 100 outputs the laser. The catheter structure 100 emits the laser directly through the distal end of the quartz tube 121, so that the laser directly acts on the lesion site.

[0071] In this way, after the laser emits a laser of a predetermined wavelength, the laser enters the hollow anti-resonant fiber 122 and travels along the fiber from the proximal end to the distal end, entering the quartz tube 121 and then exiting through it. At this point, the distal end of the catheter structure 100 directly outputs the laser, which can interact with the tissue at the lesion site to achieve the therapeutic purpose. That is, the catheter structure 100 provides a separate laser ablation mode for ablation treatment of the lesion site.

[0072] Of course, in other embodiments, the ablation tube 120 also includes a hollow cavity located at the distal end of the accommodating space 113 and the quartz tube 121. The laser is emitted through the hollow anti-resonant optical fiber 122, the quartz tube 121, and the cavity, so that the distal end of the conduit structure 100 outputs laser light. That is, the distal end of the ablation tube 120 is provided with a hollow cavity, and no filling is provided in the cavity to avoid obstructing the laser, so that the laser can be emitted directly through the cavity.

[0073] In this way, after the laser emits a laser of a predetermined wavelength, the laser enters the hollow anti-resonant fiber 122 and travels along the fiber from the proximal end to the distal end, entering the quartz tube 121 and exiting through it. The laser emitted from the quartz tube 121 then enters the hollow cavity and exits directly through it. At this point, the distal end of the catheter structure 100 directly outputs laser light, which can interact with the tissue at the lesion site to achieve the therapeutic purpose. That is, the catheter structure 100 provides a separate laser ablation mode for ablation treatment of the lesion site.

[0074] See Figures 4 to 6 In the second embodiment of this application, the distal end of the catheter structure 100 is capable of outputting shock waves. That is, the catheter structure 100 provides a separate shock wave ablation mode for ablation treatment of the lesion site. After the laser emits a laser of a predetermined wavelength, the laser enters the hollow anti-resonant fiber 122 and travels along the fiber from proximal to distal end into the quartz tube 121. The laser then exits through the quartz tube 121 and is processed at the distal end of the catheter structure 100, allowing the distal end of the catheter structure 100 to directly output shock waves. These shock waves can interact with the tissue at the lesion site to achieve the therapeutic purpose.

[0075] See Figure 5 , Figure 6 , Figure 8 and Figure 9 In one embodiment, the ablation tube 120 further includes a receiving cavity 123, which is located at the distal end of the receiving space 113 and the quartz tube 121. The receiving cavity 123 is filled with a filling agent 130. A laser is injected into the receiving cavity 123 through the hollow anti-resonant optical fiber 122 and the quartz tube 121, so that the filling agent 130 in the receiving cavity 123 generates a pressure change and forms a shock wave, so that the distal end of the catheter structure 100 outputs a shock wave.

[0076] In other words, a receiving cavity 123 is provided at the distal end of the ablation tube 120, and the receiving cavity 123 is filled with a filling agent 130. That is, the distal end of the conduit structure 100 is provided with a receiving cavity 123 filled with a filling agent 130. In this way, after the laser emits a laser of a predetermined wavelength, the laser enters the hollow anti-resonant optical fiber 122, and travels along the hollow anti-resonant optical fiber 122 from the proximal end to the distal end and enters the quartz tube 121, and then exits through the quartz tube 121.

[0077] The laser emitted from the quartz tube 121 directly acts on the filling agent 130 in the cavity 123. Due to the extremely small size and extremely high energy density of the laser spot, the filling agent 130 located at the spot vaporizes or even ionizes in a very short time to form a cavitation bubble. The cavitation bubble then expands and then collapses and disappears. The generation, expansion, and collapse of the cavitation bubble cause pressure changes in the filling agent 130 around the cavitation bubble and form a shock wave.

[0078] This shockwave acts directly and axially at close range on the lesion site for treatment, avoiding energy attenuation and improving therapeutic efficacy. Specifically, the catheter structure 100 provides a dedicated shockwave ablation mode for lesion ablation. It should be noted that the shockwave intensity can reach 2MPa~100MPa, effectively breaking up plaques or calcified lesions. This provides a new solution for treating lesions where balloons are difficult to pass through or dilate.

[0079] See Figure 5 , Figure 6 , Figure 8 and Figure 9 In one embodiment, the filling agent 130 is a liquid that absorbs laser energy. Thus, after absorbing laser energy, the filling agent 130 can vaporize or even ionize in a very short time to form cavitation bubbles. These bubbles then expand and eventually collapse. The generation, expansion, and collapse of the cavitation bubbles cause pressure changes in the filling agent 130 surrounding the bubbles, forming shock waves. These shock waves act directly and axially at close range on the lesion site, avoiding shock wave energy attenuation and improving the treatment effect.

[0080] It should be noted that the type of filling agent 130 is not limited in principle, as long as the filling agent 130 can absorb laser energy. Optionally, the filling agent 130 may include at least physiological saline, contrast agent, or a 1:1 mixture of physiological saline and contrast agent. Of course, in other embodiments, the filling agent 130 may also be other liquids capable of absorbing laser energy.

[0081] See Figure 5 , Figure 6 , Figure 8 and Figure 9 In one embodiment, the receiving cavity 123 is filled with a filling agent 130. That is, the receiving cavity 123 is completely filled with the filling agent 130. In this way, the shock wave formed after the filling agent 130 absorbs laser energy has sufficient intensity to meet the requirements of shock wave ablation therapy.

[0082] See Figure 4 and Figure 7 In one embodiment, the catheter structure 100 further includes a fluid inlet tube 140, the distal end of which extends into the receiving space 113 and communicates with the receiving cavity 123 for injecting filling agent 130 into the receiving cavity 123. The fluid inlet tube 140 is the component for injecting or replenishing the filling agent 130 into the receiving cavity 123. Part of the fluid inlet tube 140 is located between the outer tube 112 and the inner tube 111, and part is located outside the outer tube 112. Thus, the distal end of the fluid inlet tube 140 can communicate with the receiving cavity 123, and the proximal end of the fluid inlet tube 140 can communicate with an external container storing the filling agent 130. When it is necessary to inject or replenish the filling agent 130 during the procedure, the filling agent 130 can be injected into the receiving cavity 123 through the fluid inlet tube 140.

[0083] It should be noted that the cavity mentioned above and the receiving cavity 123 here are actually cavities at the distal end of the ablation tube 120. When this cavity is not filled with filling agent 130, it is defined as a cavity body; when it is filled with filling agent 130, it is defined as receiving cavity 123. During the procedure, this cavity can be filled with filling agent 130 to allow the catheter structure 100 to provide a shockwave ablation mode. Alternatively, the cavity can be left unfilled to allow the catheter structure 100 to provide a laser ablation mode. In this way, the catheter structure 100 can select an appropriate ablation mode based on the lesion site, improving the treatment effect on the lesion.

[0084] See Figures 7 to 9In the third embodiment of this application, the distal end of the catheter structure 100 is capable of outputting both laser and shock wave ablation. That is, the catheter structure 100 can provide both laser ablation and shock wave ablation modes for ablation treatment of lesions. After the laser emits a laser of a predetermined wavelength, the laser enters the hollow anti-resonant fiber 122 and travels along the fiber from proximal to distal end into the quartz tube 121, where it exits. The distal end of the catheter structure 100 directly outputs the laser, and can also process the laser to form a shock wave output. Combining these two methods allows for the treatment of lesions with high resistance, achieving the therapeutic goal.

[0085] See Figure 2 , Figure 3 , Figure 5 , Figure 6 , Figure 8 and Figure 9 In one embodiment, the conduit structure 100 includes at least two ablation tubes 120, which are spaced apart circumferentially along the inner tube 111. That is, laser delivery can be achieved using a combination of at least two hollow anti-resonant optical fibers 122 and at least two quartz tubes 121. A quartz tube 121 is disposed at the distal end of each hollow anti-resonant optical fiber 122.

[0086] exist Figure 2 , Figure 3 , Figure 5 , Figure 6 , Figure 8 and Figure 9 In the illustrated embodiment, there are two ablation tubes 120, which are evenly distributed around the outer periphery of the inner tube 111. Of course, in other embodiments, there may be one or more ablation tubes 120; for example, there may be 1 to 20 ablation tubes 120, or other numbers. The catheter structure 100 of this application uses a single or at least two hollow anti-resonant optical fibers 122 to deliver laser, which can increase the laser coupling efficiency from ≤50% to over 90%, thereby improving the treatment effect.

[0087] See Figures 1 to 3 In the first embodiment of this application, at least two ablation tubes 120 are used to output laser light from the distal end of the catheter structure 100. In this embodiment, the distal end of the ablation tubes 120 is not filled. Thus, the catheter structure 100 provides a separate laser ablation mode for ablation treatment of the lesion site.

[0088] Specifically, after the laser emits a laser of a predetermined wavelength, the laser enters the hollow anti-resonant optical fiber 122 and travels along the fiber from the proximal end to the distal end, entering the quartz tube 121. The laser then exits through the quartz tube 121 and enters the hollow cavity, exiting directly through it. At this point, the distal end of the conduit structure 100 directly outputs the laser, which can interact with the tissue at the lesion site to achieve the therapeutic purpose.

[0089] See Figures 4 to 6 In a second embodiment of this application, at least two ablation tubes 120 are used to deliver shock waves from the distal end of the catheter structure 100. In this embodiment, the receiving cavity 123 at the distal end of the ablation tube 120 is filled with a filling agent 130. Thus, the catheter structure 100 provides a separate shock wave ablation mode for ablation treatment of the lesion site.

[0090] After the laser emits a laser of a predetermined wavelength, the laser enters the hollow anti-resonant fiber 122 and travels along the fiber from near to far, eventually entering the quartz tube 121 and exiting through it. The laser emitted from the quartz tube 121 directly acts on the filling agent 130 in the cavity 123. Due to the extremely small size and high energy density of the laser spot, the filling agent 130 located at the spot vaporizes or even ionizes in a very short time to form a cavitation bubble. The cavitation bubble then expands and then collapses and disappears.

[0091] The generation, expansion, and collapse of cavitation bubbles cause pressure changes in the filling agent 130 surrounding the bubbles, forming a shock wave. This shock wave acts directly axially and close to the lesion site for treatment. It should be noted that the intensity of this shock wave can reach 2MPa~100MPa, effectively breaking up plaques or calcified lesions. This provides a new treatment option for lesions where balloons are difficult to pass through or dilate.

[0092] See Figures 7 to 9 In the third embodiment of this application, the partial ablation tube 120 is used to output laser light from the distal end of the catheter structure 100, and the partial ablation tube 120 is also used to output shock waves from the distal end of the catheter structure 100. In this embodiment, the distal end of the partial ablation tube 120 is not filled, and the receiving cavity 123 at the distal end of the partial ablation tube 120 is filled with a filling agent 130. Figure 8 and Figure 9 As shown, the distal end of the upper ablation tube 120 is filled with filling agent 130, while the distal end of the lower ablation tube 120 is not filled.

[0093] In this way, the catheter structure 100 can provide a combined laser and shock wave ablation mode to ablate lesions. Specifically, while the laser is directly output through the distal end of the catheter structure 100 via the hollow anti-resonant fiber 122 and the quartz tube 121, the hollow anti-resonant fiber 122 and the quartz tube 121 can also inject the laser into the filling agent 130 to achieve axial shock wave emission. Combining these two methods to treat lesions with high resistance greatly improves the efficiency and success rate of lesion treatment.

[0094] It is worth noting that in the above three embodiments, the only difference between the catheter structure 100 and the catheter structure 100 is whether or not the distal end of the ablation tube 120 is filled with filling agent 130. The structure of the rest of the catheter structure 100 is the same, and will not be described again below.

[0095] See Figure 10 In one embodiment, a preset distance L exists between the distal end of the hollow anti-resonant optical fiber 122 and the bottom wall of the quartz tube 121, and the preset distance L is proportional to the ablation area of ​​the conduit structure 100. Figure 10 for Figure 2 The diagram shows a partial schematic of the ablation tube 120 in the catheter structure 100. In other words, increasing the pre-set distance L between the distal end of the hollow anti-resonant optical fiber 122 and the bottom wall of the quartz tube 121 allows the catheter structure 100 to achieve a larger ablation area, thereby improving the therapeutic effect on the lesion site.

[0096] The specific calculation formula between the ablation area and the preset spacing is as follows: In the formula, S is the ablation area, L is the preset distance between the distal end of the hollow anti-resonant fiber 122 and the bottom wall of the quartz tube 121, and θ is the arcsine function of the fiber divergence angle NA. L and θ are as follows Figure 10 As shown. Once the structure of the hollow anti-resonant fiber 122 is determined, the angle θ is a constant.

[0097] At this point, the ablation area corresponding to the current preset spacing L can be calculated. Thus, during actual use, the preset spacing L between the distal end of the hollow anti-resonant optical fiber 122 and the bottom wall of the quartz tube 121 can be adjusted to regulate the ablation area of ​​the catheter structure 100, so that the ablation area of ​​the catheter structure 100 can match the lesion site, ensuring the therapeutic effect on the lesion site.

[0098] See Figure 2 , Figure 5 and Figure 8In one embodiment, an adhesive 150 is filled between the outer wall of the inner tube 111, the inner wall of the outer tube 112, and the distal end of the outer wall of the ablation tube 120. The adhesive 150 is located at the distal end of the receiving space 113 and can contact the outer wall of the inner tube 111, the inner wall of the outer tube 112, and the outer wall of the quartz tube 121, thereby achieving the bonding and fixation of the inner tube 111, the outer tube 112, and the quartz tube 121 at the distal end. This allows the inner tube 111, the outer tube 112, and the quartz tube 121 to form a fixed whole and serve as the distal end of the catheter structure 100, preventing the position of a certain tube segment from shifting and affecting the treatment effect.

[0099] See Figure 2 , Figure 5 and Figure 8 In one embodiment, the inner wall of the quartz tube 121 is provided with an adhesive 150 for bonding the hollow anti-resonant optical fiber 122. That is, a small amount of adhesive 150 can be coated on the inner wall of the quartz tube 121 to bond and fix the quartz tube 121 and the hollow anti-resonant optical fiber 122 together, increasing the stability of the fit between the quartz tube 121 and the hollow anti-resonant optical fiber 122, preventing positional shifts that could affect the stability of laser delivery, and improving the treatment effect.

[0100] See Figure 1 , Figure 4 and Figure 7 In one embodiment, the conduit structure 100 further includes an adapter 160 and a quartz optical fiber 170. The adapter 160 is disposed at the proximal end of the hollow anti-resonant optical fiber 122 and connected to the distal end of the quartz optical fiber 170. The proximal end of the quartz optical fiber 170 is used to connect to a laser.

[0101] To facilitate the connection between the near end of the hollow-core anti-resonant fiber 122 and the laser, this application provides an adapter 160 at the near end of the hollow-core anti-resonant fiber 122. The adapter 160 connects to the far end of the quartz fiber 170, and the laser is then connected to the near end of the quartz fiber 170. In this way, the laser emitted by the laser can pass through the quartz fiber 170 into the hollow-core anti-resonant fiber 122, improving the coupling effect of the laser and ensuring effective laser transmission.

[0102] See Figure 1 , Figure 4 and Figure 7In one embodiment, the catheter structure 100 further includes a contrast agent 180, which is disposed on the outer wall of the distal end of the outer tube 112. Optionally, the contrast agent 180 is a contrast ring. When the distal end of the catheter structure 100 moves in the blood vessel, the position of the distal end of the catheter structure 100 can be marked by the imaging device in cooperation with the contrast agent 180, thereby improving the accuracy of the movement of the distal end of the catheter structure 100 in the blood vessel, so that the distal end of the catheter structure 100 can reach the lesion site smoothly and accurately, thus ensuring the therapeutic effect.

[0103] See Figure 1 , Figure 4 and Figure 7 In one embodiment, the outer wall of the outer tube 112 near its distal end is further provided with a guidewire port 1121 communicating with the inner lumen of the inner tube 111. The inner lumen of the inner tube 111 is hollow, allowing interventional instruments such as guidewires to move within the lumen of the inner tube 111 to treat the lesion. During surgery, a guiding catheter is typically implanted into the patient, with the distal end of the catheter structure 100 extending into and moving along the guiding catheter. Furthermore, the guidewire can also move within the guiding catheter, and thus pass through the guidewire port 1121 of the outer tube 112 into the inner lumen of the inner tube 111.

[0104] See Figure 1 , Figure 4 and Figure 7 In one embodiment, the inner tube 111 and the outer tube 112 are made of polymer material. The inner tube 111 and the outer tube 112 made of polymer material can have a certain structural strength and bending performance. While supporting the various components of the catheter structure 100, they can also bend with the blood vessel to facilitate the movement of the distal end of the catheter structure 100 to the lesion site.

[0105] See Figure 1 , Figure 4 and Figure 7 In one embodiment, the outer diameter of the outer tube 112 ranges from 0.5 mm to 2.5 mm, and the axial length of the outer tube 112 ranges from 1000 mm to 3000 mm. This satisfies the requirements for ablation therapy.

[0106] The catheter structure 100 of this application uses a hollow anti-resonant optical fiber 122 as the transmission structure to deliver laser to the distal quartz tube 121, improving laser coupling efficiency and significantly increasing laser energy transmission efficiency. Simultaneously, it reduces the overall size of the catheter structure 100, improves its passage through blood vessels, and gives it a longer and more stable service life, better meeting the needs of clinical applications. Furthermore, after the laser is emitted through the ablation tube 120 and the quartz tube 121, the distal end of the catheter structure 100 can provide three ablation modes: laser alone, shock wave alone, and a combination of laser and shock wave. This provides an efficient solution for opening vascular access, eliminating the need to replace treatment devices, significantly improving clinical treatment efficiency and device reliability, reducing treatment costs, and increasing treatment effectiveness.

[0107] This application also provides a laser therapy device, including a laser and a catheter structure 100 as described in any of the above embodiments. The laser is connected to the proximal end of the catheter structure 100 and is used to emit laser light into the catheter structure 100. By employing the catheter structure 100 of the above embodiments, the laser therapy device of this application can improve laser coupling efficiency, greatly improve laser energy transmission efficiency, and reduce the overall size of the catheter structure 100. Simultaneously, the distal end of the catheter structure 100 can provide three ablation modes: laser alone, shock wave alone, and a combination of laser and shock wave, providing an efficient solution for opening vascular access.

[0108] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0109] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A catheter structure, characterized by, The catheter structure comprises: a tube assembly comprising an inner tube and an outer tube sleeved outside the inner tube, the inner tube and the outer tube surrounding a containing space; and an ablation tube axially arranged in the containing space, the ablation tube comprising a quartz tube and an air-core anti-resonance optical fiber, a distal end of the air-core anti-resonance optical fiber being arranged in the quartz tube; wherein a proximal end of the air-core anti-resonance optical fiber is used to connect a laser, the laser being used to deliver laser to the air-core anti-resonance optical fiber and output through the quartz tube, so that a distal end of the catheter structure outputs energy.

2. The catheter structure of claim 1, wherein, A preset interval L exists between the distal end of the air-core anti-resonance optical fiber and a bottom wall of the quartz tube, the preset interval L being in direct proportion to an ablation area of the catheter structure.

3. The catheter structure of claim 1, wherein, An outer wall of the inner tube, an inner wall of the outer tube and a distal end of an outer wall of the quartz tube are filled with an adhesive; and / or, an inner wall of the quartz tube is provided with an adhesive for bonding the air-core anti-resonance optical fiber.

4. The catheter structure of claim 1, wherein, The distal end of the catheter structure can output laser.

5. The catheter structure of claim 4, wherein, The ablation tube further comprises a hollow cavity, the cavity being located at the distal end of the containing space and the quartz tube, laser being emitted through the air-core anti-resonance optical fiber, the quartz tube and the cavity, so that the distal end of the catheter structure outputs laser; or, the distal end of the quartz tube is coplanar with a distal end of the tube assembly, laser being emitted through the air-core anti-resonance optical fiber and the quartz tube, so that the distal end of the catheter structure outputs laser.

6. The catheter structure of claim 5, wherein, The catheter structure comprises at least two ablation tubes, the at least two ablation tubes being arranged at intervals along a circumference of the inner tube, the at least two ablation tubes being used to make the distal end of the catheter structure output laser.

7. The catheter structure of claim 1, wherein, The distal end of the catheter structure can output shock wave.

8. The catheter structure of claim 7, wherein, The ablation tube further comprises a containing cavity, the containing cavity being located at the distal end of the containing space and the quartz tube, the containing cavity being filled with a filling agent, laser being emitted through the air-core anti-resonance optical fiber and the quartz tube into the containing cavity, so that the filling agent in the containing cavity generates pressure change and forms shock wave, so that the distal end of the catheter structure outputs shock wave.

9. The catheter structure of claim 8, wherein, The catheter structure comprises at least two ablation tubes, the at least two ablation tubes being arranged at intervals along a circumference of the inner tube, the at least two ablation tubes being used to make the distal end of the catheter structure output shock wave.

10. The catheter structure of claim 8, wherein, The filling agent is a liquid that absorbs laser energy, and at least comprises physiological saline, contrast agent or a mixed solution of physiological saline and contrast agent; and / or, the containing cavity is filled with the filling agent; and / or, the catheter structure further comprises a liquid passage tube, a distal end of the liquid passage tube extending into the containing space and communicating with the containing cavity, for injecting the filling agent into the containing cavity.

11. The catheter structure of claim 1, wherein, The distal end of the catheter structure can output laser and output shock wave.

12. The catheter structure of claim 11, wherein, The catheter structure comprises at least two ablation tubes, the at least two ablation tubes being arranged at intervals along a circumference of the inner tube, part of the ablation tubes being used to make the distal end of the catheter structure output laser, and part of the ablation tubes being used to make the distal end of the catheter structure output shock wave.

13. The catheter structure of any of claims 1 to 12, wherein, The catheter structure further comprises an adapter arranged at the proximal end of the hollow-core anti-resonant optical fiber and connected to the distal end of a quartz optical fiber, the proximal end of the quartz optical fiber being used for connecting the laser; And / or, the catheter structure further comprises a developing member arranged at the outer wall of the distal end of the outer tube; And / or, the outer tube is further provided with a guide wire port in communication with the inner cavity of the inner tube at the outer wall of the distal end; And / or, the inner tube and the outer tube are made of a polymer material; And / or, the outer tube has an outer diameter ranging from 0.5mm to 2.5mm, and an axial length ranging from 1000mm to 3000mm.

14. A laser treatment device, characterized by The catheter structure according to any one of claims 1 to 13; and a laser. The laser is connected to the proximal end of the catheter structure and used for emitting laser to the catheter structure.

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