Laser shock waveguide and laser driving system

Abstract

This application relates to the field of medical device technology, specifically to a laser shockwave conduit and laser driving system. The laser shockwave conduit includes: a conduit body having opposing proximal and distal ends; at least one optical fiber extending within the conduit body, the proximal end of which receives laser energy, and the distal end extending into the interior of the conduit body; and at least one reinforcing member disposed within the conduit body, the reinforcing member having a receiving surface spaced apart from the distal end of the optical fiber, the receiving surface being used to receive laser energy emitted from the optical fiber to generate plasma. The laser energy transmitted through the optical fiber is precisely applied to the receiving surface of the reinforcing member, exciting plasma in a liquid medium and generating a shock wave. This shock wave can penetrate soft tissue and effectively target deep, even annular, calcified plaques, overcoming the limited effectiveness of traditional methods for deep calcification.

Description

Technical Field

[0001] This application relates to the field of medical device technology, specifically to a laser shock waveguide and laser driving system. Background Technology

[0002] Percutaneous coronary intervention (PCI) is the primary treatment for coronary atherosclerosis. However, with increasingly complex lesions and severe vascular calcification, PCI presents significant challenges.

[0003] Related techniques mainly treat calcified lesions through high-pressure balloon dilation, cutting balloons, or rotational atherectomy. However, these methods have significant drawbacks: high-pressure dilation relies on mechanical compression, which has limited effectiveness on deep calcifications and easily leads to complications such as vascular dissection and perforation; cutting balloons mainly act on superficial layers, are not effective in improving annular calcifications, and pose a risk of damage to sharp structures; rotational atherectomy is complex to operate, has a long learning curve, and the microparticles generated during grinding may cause distal embolism and no-reflow phenomenon. Summary of the Invention

[0004] This application provides a laser shockwave catheter and laser driving system to address the limitations of related technologies in treating deep and circumferential calcifications, as well as the problems of vascular damage, high risk of embolism, and complex operation.

[0005] The first aspect of this application provides a laser shock waveguide, comprising: The catheter body has a proximal end and a distal end; At least one optical fiber extends within the catheter body, with the proximal end of the optical fiber used to receive laser energy and the distal end of the optical fiber extending into the interior of the catheter body. At least one reinforcement member is disposed inside the conduit body, the reinforcement member having a receiving surface spaced apart from the distal end of the optical fiber, the receiving surface being used to receive laser energy emitted from the optical fiber to generate plasma.

[0006] Optionally, the receiving surface is at least partially made of a metallic material, or at least partially made of a non-metallic material; The metallic material is selected from at least one of aluminum, titanium, niobium, molybdenum, tantalum, and tungsten, and the non-metallic material is selected from at least one of graphite, boron nitride, aluminum nitride, aluminum oxide, and zirconium oxide.

[0007] Optionally, it also includes: A balloon is disposed at the distal end of the catheter body, and the reinforcement is disposed within the balloon; A guidewire lumen extending axially along the catheter body, the guidewire lumen being used for threading a guidewire, and at least a portion of the reinforcement being fixed to the outer wall of the guidewire lumen.

[0008] Optionally, the reinforcement has an arcuate inner wall surface that adapts to the outer peripheral wall of the guidewire lumen for fixing to the guidewire lumen.

[0009] Optionally, the reinforcement is a tubular structure sleeved on the guidewire lumen; or, The reinforcement is a tubular structure with a notch, and the reinforcement is clamped onto the guidewire lumen; or, The reinforcing member has a block-shaped structure and an arc-shaped inner wall surface that fits against the outer wall of the guidewire lumen; or The reinforcing member is a receiving plate structure integrally formed with the guide wire cavity.

[0010] Optionally, the reinforcement includes a locking part and a fixing part, wherein the locking part is used to fix the optical fiber; The fixing part is used to connect the guide wire lumen.

[0011] Optionally, there are multiple optical fibers, and the multiple optical fibers are symmetrically arranged along the guide wire cavity or uniformly spaced in the radial direction; There are multiple reinforcing members, each corresponding to one of the multiple optical fibers, and the multiple reinforcing members are symmetrically arranged along the guide wire cavity or spaced apart along the axial direction; Alternatively, the reinforcement member may be a single member, which may have a plurality of engaging portions along its circumferential direction for fixing the optical fiber.

[0012] Optionally, the receiving surface includes at least two intersecting planes along the emission direction of the laser energy emitted from the optical fiber; or, The receiving surface is an inclined plane and forms a preset angle with the optical axis of the optical fiber; Alternatively, the receiving surface may be a toroidal surface or an arc-shaped surface.

[0013] Optionally, the distal end of the catheter body is provided with a tip, which has a structure with or without a radiopaque ring; And / or, the laser shock wave conduit further includes a connector portion connected to the proximal end of the conduit body, the connector portion having a drainage channel communicating with the interior of the conduit body.

[0014] A second aspect of this application provides a laser driving system, including a laser shock waveguide as described above, and a laser generating device for providing pulsed laser energy to the optical fiber.

[0015] Beneficial Effects: The laser shockwave catheter provided in this application achieves a novel mechanism for efficiently converting laser energy into mechanical shock waves by incorporating an enhancement element corresponding to the distal end of the optical fiber within the catheter body. First, the laser energy transmitted through the optical fiber is precisely applied to the receiving surface of the enhancement element, exciting plasma in the liquid medium and generating a shock wave. This shock wave can penetrate soft tissue and effectively target deep, even annular, calcified plaques, overcoming the limited effectiveness of traditional methods on deep calcification. Second, the shock wave is uniformly transmitted through the liquid medium, acting as a non-contact, non-thermal mechanical force, avoiding direct compression damage to the vessel wall caused by high-pressure expansion and the risk of vascular dissection that may result from cutting structures, significantly improving surgical safety. The intensity and range of the shock wave can be precisely controlled by adjusting various parameters of the enhancement element, making the operation simple and avoiding the generation of solid particles, thus avoiding the distal embolism risk associated with rotational atherectomy. This provides a safe, efficient, and simple new solution for the treatment of severely calcified lesions. Attached Figure Description

[0016] To more clearly illustrate the technical solutions in the specific embodiments or related technologies of this application, the drawings used in the description of the specific embodiments or related technologies will be briefly introduced below. Obviously, the drawings described below are some embodiments of this application. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0017] Figure 1 This is a schematic diagram of the structure of a laser shock waveguide according to an embodiment of this application; Figure 2 This is a schematic diagram of the structure of a catheter body according to an embodiment of this application; Figure 3 This is a partial cross-sectional view of the catheter body according to an embodiment of this application; Figure 4 This is a partial structural schematic diagram of a laser shock waveguide according to an embodiment of this application; Figure 5 This is a schematic diagram of the structure of a multi-way valve according to an embodiment of this application; Figure 6 This is a partial structural schematic diagram of a conduit and a multi-way valve according to an embodiment of this application; Figure 7 This is a schematic diagram of a partial structure of the catheter and balloon according to one embodiment of this application. Figure 1 ; Figure 8 This is a schematic diagram of a partial structure of the catheter and balloon according to one embodiment of this application. Figure 2 ; Figure 9 This is a schematic diagram of a partial structure of the catheter and balloon according to one embodiment of this application. Figure 3 ; Figure 10 A cross-sectional view of a laser shock waveguide according to an embodiment of this application. Figure 1 ; Figure 11 This is a partial cross-sectional view of a laser shock waveguide according to an embodiment of this application; Figure 12 A cross-sectional view of a laser shock waveguide according to an embodiment of this application. Figure 2 ; Figure 13 This is a schematic diagram of the structure of the reinforcement in the first embodiment of this application; Figure 14 This is a schematic diagram of the reinforcement component according to the second embodiment of this application; Figure 15 This is a schematic diagram of the reinforcement component according to the third embodiment of this application; Figure 16 This is a schematic diagram of the reinforcement component according to the fourth embodiment of this application; Figure 17 This is a schematic diagram of the reinforcement component according to the fifth embodiment of this application; Figure 18 This is a schematic diagram of the reinforcement component according to the sixth embodiment of this application; Figure 19 This is a schematic diagram of the reinforcement component according to the seventh embodiment of this application; Figure 20 This is a schematic diagram of the reinforcement component according to the eighth embodiment of this application; Figure 21 This is a schematic diagram of the reinforcement component according to the ninth embodiment of this application; Figure 22 This is a schematic diagram of the reinforcement component according to the tenth embodiment of this application; Figure 23 This is a schematic diagram of the structure of the reinforcement in the eleventh embodiment of this application; Figure 24 This is a schematic diagram of the reinforcement component according to the twelfth embodiment of this application; Figure 25 This is a schematic diagram of the structure of the reinforcement according to the thirteenth embodiment of this application; Figure 26 This is a schematic diagram of the structure of the catheter body and ablation catheter according to one embodiment of this application. Figure 1 ; Figure 27 This is a schematic diagram of the structure of the catheter body and ablation catheter according to one embodiment of this application. Figure 2 ; Figure 28 This is a partial cross-sectional view of the catheter body according to the first embodiment of this application; Figure 29This is a partial cross-sectional view of the catheter body according to the second embodiment of this application; Figure 30 This is a partial cross-sectional view of the catheter body according to the third embodiment of this application; Figure 31 This is a partial cross-sectional view of the catheter body according to the fourth embodiment of this application.

[0018] Explanation of reference numerals in the attached figures: 1. Catheter body; 101. Proximal end of catheter; 102. Distal end of catheter; 103. Transition section; 104. Tip; 105. Inner layer; 106. Braided layer; 107. Outer layer; 108. Fluid outlet chamber; 2. Balloon; 201. Balloon inflation chamber; 3. Optical fiber; 4. Reinforcing element; 401. Receiving surface; 402. Engaging part; 403. Fixing part; 501. Guidewire lumen; 502. Guidewire lumen; 503. Guidewire; 6. Imaging ring; 7. Equipment connector assembly; 8. Multi-port valve; 801. Laser interface; 802. Liquid interface; 803. Guidewire interface; 804. Drain port; 9. Ablation catheter. Detailed Implementation

[0019] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0020] To address the challenges of difficult passage, insufficient dilation, and poor prognosis associated with severe vascular calcification during percutaneous coronary intervention, the following techniques are primarily employed to manage these issues.

[0021] (a) High-pressure balloon dilation technique; In related technologies, the high resistance of calcified lesions is often overcome by increasing the balloon dilation pressure, thereby achieving mechanical dilation of the vascular lumen.

[0022] The drawbacks are that high-pressure dilation mainly relies on mechanical compression, which has limited effect on dense or deep calcified tissues. When the dilation pressure continues to rise, it can easily damage the intima and media of blood vessels, increasing the risk of complications such as vascular dissection, perforation, and acute occlusion, thus limiting its safety.

[0023] (ii) Cutting balloon or scoring balloon technique; To improve the efficiency of high-pressure balloon dilation, related technologies propose setting cutting blades or scoring structures on the surface of the balloon to treat calcified lesions through localized stress concentration.

[0024] The limitations are that this type of technology mainly acts on the inner surface of blood vessels or superficial tissues, and has limited effect on improving deep or ring-shaped calcified lesions. Furthermore, its sharp structure may cause uncontrollable damage to the vessel wall during dilation, still posing a risk of dissection and perforation.

[0025] (iii) Rotary grinding or orbital grinding technology; For severe calcified lesions, related technologies also employ rotary grinding devices, which use high-speed rotating grinding heads to mechanically grind the calcified tissue in order to improve lumen compliance.

[0026] The drawbacks are that this type of technique is complex to operate, highly dependent on the operator's experience, and has a long learning curve; at the same time, it may generate tiny particles during the grinding process, increasing the risk of distal embolism and no-reflow phenomenon, which limits its application in some patients.

[0027] The first aspect of this application provides a laser shockwave catheter to address various problems in related technologies. This catheter is mainly used for the treatment of intravascular calcified lesions, such as severe calcified lesions in the coronary arteries.

[0028] Reference Figures 1-31 As shown, the catheter includes a catheter body 1, at least one optical fiber 3, and at least one reinforcing member 4.

[0029] The catheter body 1 has a proximal end and a distal end, namely the proximal end 101 and the distal end 102. The proximal end is the operating end, which is connected to the external control device, and the distal end is the interventional end, which is used to penetrate deep into the blood vessel to reach the lesion site. The catheter body 1 can also be referred to as the external catheter.

[0030] Specifically, at least one optical fiber 3 extends into the interior of the catheter body 1. The proximal end of the optical fiber 3 is used to receive pulsed laser energy from the laser generating device, and the distal end of the optical fiber 3 extends into the interior of the catheter body 1. The optical fiber 3 is a high-purity quartz multimode optical fiber with a core diameter of 50μm–600μm and is covered with a biocompatible polymer buffer layer.

[0031] At least one reinforcing member 4 is disposed inside the conduit body 1. The reinforcing member 4 has a receiving surface 401, which is spaced apart from the distal end of the optical fiber 3. When pulsed laser energy is emitted from the distal end of the optical fiber 3, the receiving surface 401 receives the laser energy emitted from the optical fiber 3 to generate plasma.

[0032] In practical applications, a balloon can be placed inside the catheter body 1. By filling the balloon with liquid and placing the distal end of the fiber optic cable 3 and the reinforcing element 4 inside the balloon, laser energy can be efficiently converted into a mechanical shock wave to act on calcified plaques. Alternatively, the distal end of the fiber optic cable 3 and the reinforcing element 4 can be directly placed inside the catheter body 1. Specifically, when the catheter body 1 adopts a multi-cavity structure design, a closed shock wave generating chamber can be formed inside. This chamber is isolated from the external vascular environment and pre-filled with a liquid medium such as saline or contrast agent. A window is opened at the distal end of the shock wave generating chamber, and the reinforcing element 4 is installed at this window, corresponding to the distal end of the fiber optic cable 3. Plasma and shock waves are generated in the liquid medium within the shock wave generating chamber. These shock waves are transmitted outward through the chamber wall (or an acoustic transmission window located on the chamber wall) and act on the calcified plaques on the vessel wall. This arrangement allows the fiber optic cable 3 and the reinforcing element 4 to be completely independent of other components within the catheter body 1, without interference. It is particularly suitable for designs that need to accommodate multiple fiber optic cables 3 simultaneously and where a simplified internal structure of the catheter body 1 is desired. (Refer to...) Figures 26-31 As shown.

[0033] The laser shockwave catheter provided in this application achieves a novel mechanism for efficiently converting laser energy into mechanical shock waves by incorporating a reinforcing element 4 corresponding to the distal end of the optical fiber 3 within the catheter body 1. First, the laser energy transmitted through the optical fiber 3 is precisely applied to the receiving surface 401 of the reinforcing element 4, exciting plasma in the liquid medium and generating a shock wave. This shock wave can penetrate soft tissue and effectively target deep, even annular, calcified plaques, overcoming the limited effectiveness of traditional methods on deep calcification. Second, the shock wave is uniformly transmitted through the liquid medium, acting as a non-contact, non-thermal mechanical force, avoiding direct compression damage to the vessel wall from high-pressure expansion and the risk of vascular dissection that may result from cutting structures, significantly improving surgical safety. The intensity and range of the shock wave can be precisely controlled by adjusting various parameters of the reinforcing element 4, making the operation simple and avoiding the generation of solid particles, thus avoiding the distal embolism risk associated with rotational atherectomy. This provides a safe, efficient, and convenient new solution for the treatment of severely calcified lesions.

[0034] In one alternative implementation, refer to Figures 7-12 As shown, the laser shockwave catheter also includes a balloon 2, which is positioned at the distal end 102 of the catheter. When not inflated, the balloon 2 is folded and closely fitted to the guidewire lumen 501 to facilitate catheter delivery within the blood vessel. The folded diameter of the balloon 2 is ≤1.2mm, a size that ensures the catheter can smoothly pass through narrow lesion areas. When the catheter reaches the target lesion location, the balloon 2 is inflated by injecting contrast agent or saline solution externally.

[0035] Optionally, the catheter body 1 adopts a coaxial multi-lumen structure design, which integrates multiple functional channels. Specifically, the catheter body 1 has a guidewire lumen 502 inside for inserting a standard-sized guidewire 503, such as a 0.014-inch diameter guidewire 503. The guidewire 503 plays a role in guiding and supporting the catheter to the lesion site during surgery. In use, the guidewire 503 is first inserted into the blood vessel through the puncture point. Under the guidance of imaging equipment, the guidewire 503 passes through the lesion site to reach the distal end of the target location. Then, the laser shockwave catheter is pushed along the guidewire 503, so that the distal end 102 of the catheter smoothly passes through the tortuous blood vessel and the narrow lesion along the trajectory of the guidewire 503, and finally reaches the calcified plaque.

[0036] Furthermore, the catheter body 1 also has an internal fiber optic channel to accommodate and protect the fiber optic cable 3. Simultaneously, the space formed between the catheter body 1 and the balloon 2, or an independent channel within it, can serve as the balloon inflation chamber 201 for delivering liquid media into the balloon 2. The balloon inflation chamber 201 is typically filled with contrast agent, saline solution, or a mixture of contrast agent and saline solution in a specific ratio. This compact coaxial multi-lumen structure of the catheter body 1 integrates multiple functions, including guidewire 503 passage, balloon 2 inflation, and energy conduction, while maintaining a relatively small overall outer diameter of the catheter body 1.

[0037] In one optional embodiment, the catheter body 1 includes a guidewire lumen 501 extending axially therein, which is independently disposed for threading a guidewire 503. At least a portion of the reinforcement 4 is fixed to the outer wall of the guidewire lumen 501. Fixing the reinforcement 4 to the guidewire lumen 501 allows the guidewire lumen 501 to serve as a stable support structure, ensuring that the reinforcement 4 will not shift under repeated shock wave action, thus guaranteeing the accuracy and reliability of the treatment. Simultaneously, this arrangement allows the optical fiber 3 and the reinforcement 4 to be separated from the guidewire 503 channel, resulting in a clear structure that facilitates manufacturing and assembly.

[0038] Specifically, the reinforcing member 4 has an arc-shaped inner wall surface that adapts to the outer peripheral wall of the guidewire lumen 501, thereby achieving a stable connection between the reinforcing member 4 and the guidewire lumen 501. This arc-shaped design increases the contact area between the two, allowing the reinforcing member 4 to fit tightly against the guidewire lumen 501. Various fixing methods can be employed, such as bonding with biocompatible adhesives, or fixing through hot melting, heat shrink wrapping with polymer materials, laser welding, etc. Optionally, the adhesive can be a light-curing adhesive or epoxy resin to ensure reliable connection under high pressure and shock wave environments.

[0039] In one alternative implementation, the reinforcement 4 can be specifically configured in various structural forms. Specifically, refer to... Figure 13As shown, the reinforcing element 4 can be a complete tubular structure fitted onto the guidewire lumen 501. The reinforcing element 4, fitted onto the outside of the guidewire lumen 501, occupies less space within the balloon 2, ensuring a smaller overall outer diameter of the balloon 2. Furthermore, this tubular reinforcing element 4 uniformly receives the pulse energy from the optical fiber 3, circumferentially uniformly receiving laser energy from the optical fiber 3 to generate radially circumferential shock waves. The shock wave intensity near the inner tube is less than that near the balloon 2, making it suitable for treating annular calcified lesions. The inner wall of the tubular reinforcing element 4 is tightly fitted to the outer wall of the guidewire lumen 501, and its end face can serve as a receiving surface 401.

[0040] Optionally, refer to Figure 14 As shown, the reinforcement 4 can also be a tubular structure with a notch, i.e., an open-loop retaining ring. Besides bonding or welding, the reinforcement 4 can also be fixed to the guide wire lumen 501 using a mechanical locking structure. Specifically, an annular groove or partial recess can be provided on the outer wall of the guide wire lumen 501, and the inner wall surface of the reinforcement 4 can be inserted into this groove to achieve dual axial and circumferential positioning. This locking structure can withstand repeated impacts from higher-intensity shock waves, preventing the reinforcement 4 from shifting during long-term use, while eliminating the need for adhesives and avoiding risks related to glue aging or biocompatibility.

[0041] Optionally, refer to Figures 21-25 As shown, the reinforcement 4 can also be designed as a block structure with an arc-shaped inner wall surface that fits against the outer wall of the guidewire lumen 501, ensuring a smaller overall outer diameter of the balloon 2. Multiple such block reinforcements 4 can be distributed radially or axially along the guidewire lumen 501. For example, two, three, or four block reinforcements 4 can be placed on the same cross-section of the guidewire lumen 501, each cooperating with a corresponding optical fiber 3 to generate directional shock waves, suitable for treating eccentric or annular calcified plaques.

[0042] Optionally, the reinforcing member 4 is a receiving plate structure integrally formed with the guide wire cavity 501. It is made by forging or embedding the guide wire cavity 501. The process is simple, the reinforcing member 4 is not easy to fall off, and the diameter of the catheter is further reduced.

[0043] In practical applications, the specific material of the receiving surface 401 can be flexibly selected according to actual needs. In one optional embodiment, the reinforcing member 4 of the receiving surface 401 is at least partially made of a metallic material, or at least partially made of a non-metallic material. Specifically, the metallic material can be selected from stainless steel, or at least one of aluminum, titanium, niobium, molybdenum, tantalum, and tungsten. The metallic material can more effectively absorb laser energy to generate plasma. The non-metallic material can be selected from at least one of graphite, boron nitride, aluminum nitride, alumina, or zirconium oxide. For example, it can be a graphite sheet or an aluminum nitride sheet, or a carbonized polymer material such as polyimide. In practical applications, it can be used in any combination. Compared with target materials of other materials, the receiving surface 401 after mixing the above materials has a lower laser ablation threshold and better matching with the acoustic impedance of the liquid medium. That is, the ablation threshold of the above materials is lower than the laser energy density. Under the same laser energy, it can more stably induce plasma generation, forming a shock wave with higher intensity and better repeatability, thereby improving the fragmentation efficiency and treatment consistency of calcified lesions. Furthermore, the receiving surface 401 is designed to be a material that combines metal and non-metal parts, which can ensure efficient energy conversion and utilize the excellent properties of non-metallic materials. Moreover, the metal and non-metal parts can be combined through methods such as inlay, coating, and welding.

[0044] In an alternative implementation, the reinforcement 4 may employ a composite structural design. (Refer to...) Figure 13 and Figure 14 As shown, the reinforcement 4 includes a locking part 402 and a fixing part 403. The locking part 402 has an elongated, perforated structure and is used to clamp or fix the distal end of the optical fiber 3, ensuring that the distal end of the optical fiber 3 maintains a precise distance and angle with the receiving surface 401 of the reinforcement 4. The fixing part 403 is used to connect to the guide wire cavity tube 501. The specific materials of the locking part 402 and the fixing part 403 can be flexibly selected according to the actual fixing requirements, and will not be elaborated here.

[0045] Or, refer to Figures 20-25 As shown, the reinforcement 4 can also combine the fixing part 403 and the receiving surface 401 into one, that is, directly use metal or non-metal materials, or deposit a layer of metal material on the upper surface of the fixing part 403 as the receiving surface 401, or directly set the receiving surface 401 as a fixing structure to fix the reinforcement 4 without setting other structures.

[0046] In one alternative implementation, refer to Figures 10-12As shown, there can be multiple optical fibers 3, all of which are uniformly spaced radially along the guidewire lumen 501. For example, two, three, four, six, or eight optical fibers 3 can be uniformly arranged around the guidewire lumen 501. Correspondingly, there can also be multiple reinforcing elements 4, each corresponding to one of the multiple optical fibers 3. These reinforcing elements 4 can be distributed axially along the guidewire lumen 501. For example, within the effective working length of the balloon 2, two, three, or more rows of reinforcing elements 4 can be distributed axially, with each row consisting of multiple circumferentially distributed reinforcing elements 4, forming an array-type shock wave generating structure. This array design can generate uniformly distributed and sufficiently energetic shock waves throughout the entire effective length of the balloon 2, achieving rapid and effective treatment of long-segment calcified lesions. In practical applications, each reinforcing element 4 can also correspond to multiple optical fibers 3, forming a multi-stage shock wave source.

[0047] Alternatively, reinforcement 4 can also be a single, multi-functional component. (See reference...) Figure 13 As shown, the tubular reinforcing member 4 has a relatively long structure, and the engaging part 402 is an engaging groove provided on its outer wall for fixing the optical fiber 3. All the optical fibers 3 are inserted into these engaging structures respectively, thereby guiding the laser energy of multiple optical fibers 3 to different receiving areas on the same reinforcing member 4. This design reduces the number of parts, simplifies the internal structure of the balloon 2, and reduces the assembly difficulty.

[0048] Specifically, the spacing between the optical fiber 3 and the reinforcing member 4 is crucial for achieving efficient energy conversion. Laser energy is first transmitted through the optical fiber 3, and after exiting from the distal end of the fiber 3, it interacts with the receiving surface 401 of the reinforcing member 4 within a tiny gap, inducing plasma. Optionally, the distance between the receiving surface 401 of the reinforcing member 4 and the distal end face of the optical fiber 3 can be adjusted according to the laser parameters and the material of the reinforcing member 4; for example, in practical applications, it can be set to 0.001mm-2mm. Too small a gap may cause the distal end of the optical fiber 3 to be easily damaged by the shock wave reaction force, while too large a gap will reduce the coupling efficiency of the laser energy, leading to an increase in the plasma excitation threshold or failure to excite.

[0049] In one alternative embodiment, the gap between the receiving surface 401 of the reinforcement 4 and the distal end face of the optical fiber 3 can be ensured by a precision mechanical positioning structure. Specifically, a positioning step or limiting boss can be provided on the reinforcement 4, and the distal end of the optical fiber 3 is pressed against the positioning structure during assembly, thereby precisely controlling the gap size.

[0050] In an alternative embodiment, the receiving surface 401 of the reinforcing member 4 can be designed into various geometries as needed. The receiving surface 401 can be planar, simple to manufacture, allowing laser energy to be incident directly perpendicularly or obliquely. Alternatively, the receiving surface 401 can also be curved, such as an arcuate surface or a sphere, which helps to focus or disperse the generated shock wave in a specific direction. (See reference...) Figure 18 and Figure 20 As shown, the receiving surface 401 can also be designed as a toroidal surface. For example, for a tubular reinforcement 4, its receiving surface 401 can be an annular plane at its end or an arc-shaped region of the outer wall. This curved receiving surface 401 helps to generate a more uniform circumferential shock wave.

[0051] Specifically, refer to Figures 22-25 As shown, the receiving surface 401 can include at least two intersecting planes along the emission direction of the laser energy emitted from the fiber 3. For example, it can be designed with two receiving surfaces 401, forming a V-shaped groove, or three or four receiving surfaces 401, forming an inclined concave structure. Specifically, the laser emitted from the fiber 3 has a certain divergence angle and is not ideally parallel light. The V-shaped receiving surface 401, composed of two intersecting planes, is equivalent to creating an energy trapping structure. When the diverging laser shines on the V-shaped receiving surface 401, the two inclined planes intercept light rays from different directions, significantly increasing the energy density per unit area. Especially at the intersection of the two planes, the superposition effect of the light field is enhanced, making it easier to penetrate the liquid medium and form plasma. Furthermore, multiple planes can induce the generation of shock wave fronts with different directions, allowing the mechanical waves to diffuse more uniformly into the surrounding space, which can more effectively induce plasma generation and may generate shock waves with more complex directions, thereby achieving multi-angle and three-dimensional effects on calcified plaques.

[0052] In one alternative embodiment, the receiving surface 401 of the reinforcing member 4 can be designed as a smooth structure, or have a microstructure or rough surface. Specifically, micron-scale pits, grooves, or protrusions can be formed on the metal receiving surface 401 by laser processing or etching. These microstructures can further reduce the energy threshold of laser-induced plasma and enhance the local electric field strength, thereby stably generating shock waves at lower laser energies and improving energy conversion efficiency. Alternatively, the distal end face of the optical fiber 3 can be specially treated to optimize energy output. For example, the distal end face of the optical fiber 3 can be set as a spherical or conical surface. This structure can focus or collimate the emitted laser, making the beam act more concentrated on the receiving surface 401 of the reinforcing member 4.

[0053] Optionally, the receiving surface 401 can be an inclined plane, with a preset angle between this inclined plane and the optical axis of the fiber 3 (i.e., the direction of the laser emitted from the fiber 3), where the preset angle is 0° < preset angle < 180°. If the angle is too small (e.g., near 0°) or too large (e.g., near 180°), the receiving surface 401 tends to be parallel to the beam, the beam spot is extremely stretched, the energy density drops sharply, and it cannot penetrate the medium to generate a shock wave. While the energy density is highest at 90°, the shock wave intensity is less distributed on one side of the sphere 2, resulting in a singular effect on annular calcification and easy damage to the fiber 3. In practical applications, angles from 1° to 179° can be selected, ensuring efficient shock wave excitation while giving the wavefront an axial component, achieving multi-directional mechanical action, and preventing energy return along the original path. For example, angles of 30°, 45°, 60°, 90°, 120°, and 150° can be used. By adjusting the tilt angle, the main propagation direction of the shock wave can be controlled. When the angle is 90°, the laser is incident perpendicularly, and the shock wave may mainly propagate in the radial direction in the opposite direction; when the angle is 45°, the shock wave may have both radial and axial components.

[0054] In one alternative implementation, the balloon 2 itself needs to possess specific properties to withstand repeated bombardment by internal shock waves and effectively transfer energy. In practical applications, the wall thickness of the balloon 2 can be controlled between 0.001mm and 0.005mm. This thickness range ensures that the balloon 2 has a certain strength and pressure resistance without excessively attenuating the energy of the shock waves. The balloon 2 can be made of polymer materials such as nylon or Pebax (Polyether Block Amide, a thermoplastic elastomer) as a single layer or a combination of different materials. These materials have good flexibility and fatigue resistance, and can withstand repeated impacts from high-frequency shock waves without rupture. The choice can be made according to different clinical needs. Alternatively, the balloon 2 can also be made of polyurethane, which also has good flexibility and fatigue resistance, and better wear resistance, making it suitable for balloons 2 that require repeated expansion and contraction. The burst pressure of the balloon 2 should be ≥10 atm to ensure safety during inflation and shock wave generation. In terms of performance verification, the shock wave intensity measured at 2 mm laterally from the balloon in a saline environment should be ≥5 MPa to meet the clinical requirements for fragmentation of calcified plaques.

[0055] In one alternative embodiment, the distal end 102 of the catheter is provided with a tip 104 made of a polymer material. This tip 104 is conical or bullet-shaped, soft in texture, and can pass through the blood vessel harmlessly, preventing puncture of the vessel wall. Alternatively, the tip 104 can be designed using a composite of soft and hard materials, in addition to using a pure polymer material or an embedded imaging ring 6. For example, the proximal portion of the tip 104 may use a slightly harder material to provide support, while the distal portion may use an ultra-soft material to ensure safety. This segmented hardness design can minimize the risk of vascular injury while ensuring passability.

[0056] In one embodiment, the tip 104 has a structure without a imaging ring. By extending the length of the polymer material at the tip, a longer and finer lumen at the distal end can be used to accommodate and buffer any tiny bubbles that may be generated when a shock wave is generated, preventing bubbles from entering the human circulation and causing damage such as air embolism. However, its disadvantage is that the imaging effect under X-ray is not good.

[0057] In another embodiment, a radiopaque ring 6 is embedded within the tip 104. The radiopaque ring 6 is typically made of an X-ray-opaque material such as platinum, iridium, tantalum, or their alloys. In practical applications, the radiopaque ring 6 can be a tantalum ring. The radiopaque ring 6 can be designed as a circular ring coaxially aligned with the catheter body 1, used to accurately locate the distal end of the catheter body 1 within the blood vessel under X-ray fluoroscopy. Optionally, the radiopaque ring 6 can also be a polygonal ring, such as a triangular, quadrilateral, or hexagonal ring, or a plurality of spaced rings. In some embodiments, when the shock wave acts on the tantalum ring, the tantalum ring itself may also serve as part of the reinforcement 4, enhancing the shock wave generation effect. However, it should be noted that if the tantalum ring is embedded within the tip, it may restrict the extension of other instruments such as the ablation catheter 9 from the catheter body 1.

[0058] In an alternative embodiment, the imaging ring 6, in addition to being disposed within the tip 104, can also be disposed on the shoulder of the balloon 2 or on the guidewire lumen 501 inside the balloon 2. For example, an imaging ring 6 can be disposed at the shoulder positions at both ends of the balloon 2 to simultaneously display the proximal and distal positions of the balloon 2 under X-ray, facilitating the doctor's accurate determination of whether the balloon 2 completely covers the lesion area.

[0059] Specifically, the laser shockwave conduit also includes a device connector assembly 7, which is a connector for connecting to the laser generating device. The device connector assembly 7 consists of a device connector and an extension conduit. Its function is to connect to the laser generating device to generate a shock wave that acts on the balloon 2. By using the laser pulse-induced cavitation effect, a high-intensity pressure wave is generated through the rapid expansion and contraction of the cavitation bubble, thereby achieving precise fragmentation of calcified lesions.

[0060] In an alternative embodiment, the laser shock waveguide further includes a connector portion connected to the proximal end of the guide tube body 1. The connector portion can be a valve or other external housing with multiple interfaces. (See reference...) Figures 4-6 As shown, the connector can be a multi-way valve 8, such as a Y-shaped valve assembly or a valve body with more interfaces, such as a two-way valve or a three-way valve. The multi-way valve 8 is equipped with a laser interface 801 for connecting to the equipment connector assembly 7 of the laser generating device to achieve energy conduction. The multi-way valve 8 is also equipped with a liquid interface 802 for connecting to the balloon 2 inflation system to inject or withdraw contrast agents, saline, or other liquid media into or from the balloon 2, thus separating the functions of energy conduction and balloon 2 inflation.

[0061] In one optional embodiment, the multi-way valve 8 specifically adopts a three-way valve structure. In addition to the laser interface 801 and the liquid interface 802, this three-way valve also includes a guidewire interface 803. The guidewire interface 803 is used for the insertion of the guidewire 503. Through this interface, the guidewire 503 can be inserted into the catheter body 1 and pass through the distal end, achieving coaxial delivery of the guidewire 503, thereby ensuring that the balloon 2 can accurately reach the lesion location. This design integrates the functions of energy conduction, balloon 2 inflation, and guidewire 503 access into the same valve body, without interference between them.

[0062] In some implementations, refer to Figure 12 As shown, the catheter body 1 also has an additional fluid outlet chamber 108, and the multi-way valve 8 has a drain port 804 that communicates with the inside of the balloon 2, connecting to the fluid outlet chamber 108 inside the catheter body 1. During shockwave therapy, the interaction between the laser and the enhancement element 4 generates microbubbles and localized heat. Through the drain port 804, the air bubbles and heated liquid inside the balloon 2 can be drained during or between treatment sessions, while new cold liquid is injected, thereby reducing the risk of air embolism and cooling the balloon 2 to prevent thermal damage to vascular tissue. Although this circulating fluid structure increases the complexity of the operation, it significantly improves the safety of the treatment.

[0063] Optionally, at the multi-port valve 8, the optical fiber 3 passes through the balloon inflation chamber 201 and enters the catheter body 1. The insertion point is sealed with adhesive to fix and seal the optical fiber 3. This sealing structure ensures the high-pressure sealing of the balloon 2 inflation circuit, preventing contrast agent or saline from leaking back along the optical fiber 3 channel under high pressure, thus guaranteeing the inflation pressure of the balloon 2 and the success of the procedure. It should be noted that in practical applications, effective sealing is required at all connection points of the multi-port valve 8 and other important connection points within the catheter body 1. For example, light-curing adhesive or other sealing materials can be used for sealing.

[0064] In one alternative implementation, refer to Figures 28-31As shown, the catheter body 1 itself can also be designed as a multi-layered composite structure to adapt to the performance requirements of different sites. The catheter body 1 includes an inner layer 105, a braided layer 106, and an outer layer 107. The inner layer 105 and the outer layer 107 are made of polymer materials, such as Pebax, nylon, and TPU (Thermoplastic Polyurethane), which provide flexibility and lubricity to the catheter body 1. The braided layer 106 is a wire mesh made of stainless steel or other metal materials, embedded between the inner layer 105 and the outer layer 107, providing the catheter body 1 with anti-kink and pushing properties, enabling the catheter body 1 to be smoothly pushed to the distal end in tortuous blood vessels.

[0065] Specifically, refer to Figure 2 As shown, the rigidity and outer diameter of the catheter body 1 gradually decrease from proximal to distal. The proximal end of the catheter body 1 is relatively rigid and is responsible for transmitting thrust; the transition section 103 of the catheter body 1 gradually softens in rigidity and gradually narrows in diameter, responsible for a smooth transition; the distal end 102 of the catheter is very soft and thin, responsible for passing through tortuous blood vessels. This gradual rigidity design gives the catheter body 1 both good thrustability and excellent flexibility and vascular responsiveness, enabling it to safely pass through complex and narrow lesion areas.

[0066] In an alternative embodiment, the laser shockwave catheter can also be used in conjunction with an ablation catheter 9. In this combined design, the catheter body 1 itself can function as a microcatheter. The ablation catheter 9 can be inserted into the catheter body 1. When the tip of the ablation catheter 9 is retracted inside the catheter body 1, the solution in the catheter body 1 allows laser light to be emitted through the ablation catheter 9, forming a shockwave. When the tip of the ablation catheter 9 extends beyond the distal end 102 of the catheter, the ablation catheter 9 can independently perform laser ablation, directly vaporizing the plaque. This combined design allows physicians to flexibly choose the treatment mode according to the specific condition of the lesion, first using the ablation mode to open severely narrowed channels, and then using the shockwave mode to treat residual superficial or annular calcifications. The placement of the imaging ring 6 can simultaneously aid in shockwave enhancement and imaging localization.

[0067] In an alternative embodiment, the optical fiber 3 and the reinforcement 4 can also be designed as movable structures. Specifically, the optical fiber 3 and the reinforcement 4 can move together axially on the guidewire cavity 502. This movement can be achieved using an external traction rope. One end of the traction rope is connected to the reinforcement 4, and the other end extends outside the body, allowing for manual traction by the operator or electric traction via a motor or other drive device. To ensure that the optical fiber 3 and the reinforcement 4 do not shift due to vibration during shock wave generation, leading to inaccurate treatment, the contact surface between the reinforcement 4 and the guidewire cavity 502 needs to be designed with a certain degree of friction. Alternatively, a locking mechanism can be provided, unlocking when movement is needed and locking during treatment.

[0068] A second aspect of this application provides a laser driving system comprising a laser shock waveguide as described in any of the above embodiments, and a laser generating device for providing pulsed laser energy to an optical fiber 3. The laser generating device is connected to a laser interface 801 of the guide tube body 1.

[0069] The laser generator can produce lasers of specific wavelengths, such as those between 350nm and 1100nm. Water has a moderate absorption coefficient in this wavelength range, which is beneficial for inducing cavitation effects in liquid media. Different wavelengths of laser have different absorption characteristics in liquid media, allowing selection based on the specific lesion type and depth. The pulse parameters need to be tightly coupled with the core diameter of fiber 3, the material of the reinforcing element 4, and the gap between them to ensure stable and efficient generation of plasma and shock waves. Specifically, the pulse width can be set between 50ns and 1000ns, the single pulse energy should be ≥10mJ, the repetition frequency can be set between 1Hz and 5Hz, and the energy stability should be better than 20%. This combination of parameters ensures that a sufficiently strong shock wave is generated within the balloon 2 while avoiding thermal damage to the fiber 3 and the catheter body 1. During system operation, the intensity and frequency of the shock wave generated by the balloon catheter can be precisely controlled by controlling the output of the laser generator.

[0070] It should be noted that the various data regarding the laser generator are only an exemplary setting. In actual applications, the settings can be flexibly selected according to the actual treatment needs, and will not be elaborated upon here.

[0071] Furthermore, in practical applications, after setting the various data of the laser generating device, the relevant performance parameters of other components also need to be matched with the laser generating device, such as the catheter body 1, balloon 2, and reinforcing component 4, in order to meet the needs of clinical treatment.

[0072] Although embodiments of this application have been described in conjunction with the accompanying drawings, those skilled in the art can make various modifications and variations without departing from the spirit and scope of this application, and all such modifications and variations fall within the scope defined by the appended claims.

Claims

1. A laser shock waveguide, characterized in that, include: The catheter body (1) has a relative proximal end and a distal end; At least one optical fiber (3) extends into the catheter body (1), the proximal end of the optical fiber (3) is used to receive laser energy, and the distal end of the optical fiber (3) extends into the interior of the catheter body (1). At least one reinforcement (4) is disposed inside the conduit body (1), the reinforcement (4) having a receiving surface (401) spaced apart from the distal end of the optical fiber (3), the receiving surface (401) being used to receive laser energy emitted from the optical fiber (3) to generate plasma.

2. The laser shock waveguide according to claim 1, characterized in that, The receiving surface (401) is at least partially made of metal or at least partially made of non-metal. The metallic material is selected from at least one of aluminum, titanium, niobium, molybdenum, tantalum, and tungsten, and the non-metallic material is selected from at least one of graphite, boron nitride, aluminum nitride, aluminum oxide, and zirconium oxide.

3. The laser shock waveguide according to claim 1, characterized in that, Also includes: A balloon (2) is disposed at the distal end of the catheter body (1), and the reinforcing member is disposed inside the balloon (2); A guidewire lumen (501) extends axially along the catheter body (1), and a guidewire (503) is inserted inside the guidewire lumen (501). At least a portion of the reinforcing member (4) is fixed to the outer wall of the guidewire lumen (501).

4. The laser shock waveguide according to claim 3, characterized in that, The reinforcing member (4) has an arc-shaped inner wall surface that is adapted to the outer peripheral wall of the guide wire cavity (501) for fixing to the guide wire cavity (501).

5. The laser shock waveguide according to claim 4, characterized in that, The reinforcing member (4) is a tubular structure sleeved on the guide wire cavity (501); or, The reinforcing member (4) is a tubular structure with a notch, and the reinforcing member (4) is clamped onto the guide wire lumen (501); or, The reinforcing member (4) is a block structure with an arc-shaped inner wall surface that fits against the outer wall of the guide wire cavity (501); or The reinforcing member (4) is a receiving plate structure integrally formed with the guide wire cavity tube (501).

6. The laser shock waveguide according to claim 3, characterized in that, The reinforcing member (4) includes a locking part (402) and a fixing part (403). The locking part (402) is used to fix the optical fiber (3), and the fixing part (403) is used to connect the guide wire cavity tube (501).

7. The laser shock waveguide according to claim 3, characterized in that, There are multiple optical fibers (3), and the multiple optical fibers (3) are symmetrically arranged along the guide wire cavity (501) or uniformly spaced in the radial direction. There are multiple reinforcing members (4), which are arranged one-to-one with the multiple optical fibers (3), and the multiple reinforcing members (4) are symmetrically arranged or spaced along the guide wire cavity (501); Alternatively, the reinforcement (4) may be a single member, and the single reinforcement (4) may have a plurality of engaging portions (402) along the circumferential direction for fixing the optical fiber (3).

8. The laser shock waveguide according to any one of claims 1-7, characterized in that, The receiving surface (401) includes at least two intersecting planes along the emission directions of the laser energy emitted from the optical fiber (3); or, The receiving surface (401) is an inclined plane and forms a preset angle with the optical axis of the optical fiber (3); Alternatively, the receiving surface (401) may be an annular surface or an arc-shaped surface.

9. The laser shock waveguide according to any one of claims 1-7, characterized in that, The distal end of the catheter body (1) is provided with a tip (104), and the tip (104) has a structure with / without a radiopaque ring; And / or, the laser shock wave conduit also includes a connector connected to the proximal end of the conduit body (1), the connector having a drainage channel communicating with the interior of the conduit body (1).

10. A laser driving system, characterized in that, It includes the laser shock waveguide as described in any one of claims 1-9, and a laser generating device for providing pulsed laser energy to the optical fiber (3).

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