Energy focused forward shock waveguide

Abstract

The application provides an energy-focusing forward shock wave guide tube, relates to the technical field of shock wave guide tubes, and comprises a guide tube body, a fluid pipe, a shock wave generating assembly, a reflection wing assembly and an adjusting assembly; the guide tube body comprises a guide wire cavity and a shock wave generating cavity which are independently arranged; the fluid pipe, the reflection wing assembly and the shock wave generating assembly are all located in the shock wave generating cavity; the reflection wing assembly is located between the fluid pipe and the shock wave generating assembly, one end of the reflection wing assembly is fixed relative to the fluid pipe along the axial direction of the fluid pipe, and the other end is connected with the adjusting assembly; the adjusting assembly is in sliding fit with the fluid pipe along the axial direction of the fluid pipe and is configured to adjust the included angle between the reflection wing assembly and the fluid pipe, so as to adjust the shock wave focusing performance. The above-mentioned forward shock wave guide tube not only effectively avoids the shielding effect of the metal guide wire on the electric field distribution and the hindering of the shock wave propagation path, but also can realize the targeted disintegration of the shock wave generating assembly on different calcification degrees of lesions.

Description

Technical Field

[0001] This invention relates to the field of shock wave duct technology, and in particular to a forward shock wave duct for energy focusing. Background Technology

[0002] Coronary artery disease is one of the major cardiovascular diseases threatening human health. Among them, coronary artery calcification is particularly challenging in percutaneous coronary intervention, especially when calcification causes luminal stenosis of more than 50%, which significantly increases problems such as difficulty in balloon dilation, poor stent apposition, and high risk of aortic dissection.

[0003] In recent years, intravascular lithotripsy (IVL) has gradually become an important method for the pretreatment of calcified lesions. Its principle is mainly based on applying high-voltage pulses through electrodes on the surface of a balloon, generating a hydroelectric effect in the blood to form a localized shock wave, causing micro-fractures of calcified plaques. However, this technique has significant limitations: it relies on balloon inflation and adhesion to the vessel wall for effective discharge, making it difficult to pass through extremely narrow or occlusive lesions; the energy radiates 360° circumferentially, easily damaging normal vessel walls; it lacks energy focusing capability, resulting in low efficiency in fragmenting deep plate-like calcifications; and the guidewire penetrating the central electrode area may cause electric field distortion and discharge instability.

[0004] In response, some existing technologies have proposed the concept of "forward shock wave," but most of them adopt a single-cavity structure with the guide wire passing through the center of the electrode, which limits the scope of functional expansion and makes it impossible to dynamically adjust the degree of energy focusing. Summary of the Invention

[0005] The purpose of this invention is to provide an energy-focusing forward shock wave catheter that not only effectively avoids the shielding effect of metal guide wires on the electric field distribution and the obstruction of the shock wave propagation path, but also enables the shock wave generating component to specifically disintegrate lesions with different degrees of calcification.

[0006] To achieve the above objectives, the present invention provides the following technical solution: In a first aspect, the present invention provides an energy-focusing forward shock wave duct, comprising a duct body, a fluid tube, a shock wave generating component, a reflector component, and an adjustment component; The catheter body includes an independently configured guidewire cavity and a shock wave generating cavity, which are arranged parallel to each other along the axial direction. The fluid pipe, the reflector assembly, and the shock wave generating assembly are all located within the shock wave generating cavity. The shock wave generating assembly is used to generate a shock wave toward the distal end along the axial direction of the shock wave generating cavity. The reflector assembly is located between the fluid pipe and the shock wave generating assembly. One end of the reflector assembly is fixed relative to the fluid pipe along the axial direction of the fluid pipe, and the other end is connected to the adjusting assembly. The adjustment component slides along the axial direction of the fluid tube and is configured to adjust the angle between the reflector assembly and the fluid tube to adjust the shock wave focusing performance.

[0007] In an optional embodiment, the adjusting assembly includes a first movable ring and a connecting rod assembly. The inner end of the reflector assembly along the radial direction of the fluid tube is hinged to the fluid tube, with the hinge axis perpendicular to the axis of the fluid tube. The outer end of the reflector assembly along the radial direction of the fluid tube is hinged to one end of the connecting rod assembly, and the other end of the connecting rod assembly is hinged to the first movable ring. The first movable ring slides along the axial direction of the fluid tube.

[0008] In an optional embodiment, the fluid pipe includes a first inner pipe body and a first fixing seat, the first fixing seat being embedded in the outer pipe wall of the first inner pipe body, and the inner end of the reflector assembly being hinged to the first fixing seat.

[0009] In an optional embodiment, the first movable ring is provided with at least one connecting hole, and the first fixed seat is provided with through holes that correspond one-to-one with the connecting holes along the axial direction of the fluid pipe; The adjustment assembly also includes a first traction wire, which passes through the through hole and is fixedly connected to the connection hole.

[0010] In an optional embodiment, the reflector assembly includes a plurality of first reflectors, each of which is made of shape memory alloy and is distributed sequentially along the circumference of the fluid tube. The inner end of the first reflector is hinged to a pin on the outer wall of the fluid pipe. The first reflector is provided with a first hinge hole and a second hinge hole for mounting the pin. The central axis of the first hinge hole is eccentrically set relative to the central axis of the second hinge hole. The outer end of the first reflector is hinged to the connecting rod assembly.

[0011] In an optional embodiment, the reflector assembly includes a plurality of first reflectors distributed circumferentially along the fluid conduit; The first reflective fin extends further away from the fluid tube along the radial direction of the fluid tube, towards the far end of the fluid tube; And / or, both sides of the first reflector wing are provided with a clearance structure, with the clearance structure on one side located at the end of the side closest to the connecting rod assembly, and the clearance structure on the other side located at the end of the side furthest from the connecting rod assembly.

[0012] In an optional embodiment, the adjustment assembly includes a second moving ring and an elastic element; The second moving ring slides along the axial direction of the fluid tube and is slidably engaged with the fluid tube. An elastic element is provided between the second moving ring and the fluid tube. The elastic element is used to apply a restoring force to the second moving ring toward the distal end of the fluid tube. The inner end of the reflector assembly along the radial direction of the fluid pipe is connected to the second moving ring, and the outer end of the reflector assembly along the radial direction of the fluid pipe is connected to the shock wave generating assembly.

[0013] In an optional embodiment, the reflector assembly includes a plurality of second reflectors, each of which is a flexible member and has a metal reflective layer on one side along the axial direction of the fluid pipe.

[0014] In an optional embodiment, the reflector assembly includes a plurality of third reflectors made of shape memory alloy components, the third reflectors being hinged to the fluid tube along their radially inner sides, and the adjustment assembly including a plurality of third traction wires connected in a one-to-one correspondence with the plurality of third reflectors.

[0015] In an optional embodiment, an operating component is connected to the proximal end of the catheter body. The operating component is connected to the adjusting component and is used to drive the adjusting component to slide along the axial direction of the fluid tube.

[0016] The energy-focusing forward shock waveguide provided by this invention can produce the following beneficial effects: 1. The present invention adopts a dual-cavity design with independent guide wire cavity and shock wave generating cavity. Compared with the design of the guide wire passing through the center of the electrode in the prior art, the above design effectively avoids the shielding effect of the metal guide wire on the electric field distribution and the obstruction of the shock wave propagation path, ensuring that the forward shock wave can be released in a directional manner without interference, significantly improving energy utilization efficiency and discharge stability. In addition, the above dual-cavity layout also provides sufficient space for the adjustment component, realizing the controllable adjustment of the focusing degree.

[0017] 2. The angle between the reflector assembly and the fluid tube is adjustable, allowing the shock wave focusing performance to dynamically adapt to different calcification morphologies within the required range, enabling the shock wave generating assembly to target and dismantle lesions with different degrees of calcification. Attached Figure Description

[0018] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0019] Figure 1This is a schematic diagram of the structure of the forward shock waveguide for energy focusing provided in Embodiment 1 of the present invention; Figure 2 for Figure 1 A magnified view of part A; Figure 3 A schematic diagram of the cross-sectional structure of the forward shock waveguide for energy focusing provided in Embodiment 1 of the present invention; Figure 4 This is a three-dimensional structural diagram of the reflector assembly in the deployed state according to Embodiment 1 of the present invention; Figure 5 This is a three-dimensional structural diagram of the reflector assembly in the retracted state according to Embodiment 1 of the present invention; Figure 6 This is a three-dimensional structural schematic diagram of the first moving ring provided in Embodiment 1 of the present invention; Figure 7 This is a perspective view of the first moving ring provided in Embodiment 1 of the present invention; Figure 8 This is a three-dimensional structural schematic diagram of the first fixing seat provided in Embodiment 1 of the present invention; Figure 9 This is a perspective view of the first fixing base provided in Embodiment 1 of the present invention; Figure 10 This is a three-dimensional structural diagram of the reflector assembly connected to the first fixed base according to Embodiment 1 of the present invention; Figure 11 This is a three-dimensional structural schematic diagram of the first reflector provided in Embodiment 1 of the present invention; Figure 12 Perspective view of the first reflective wing provided in Embodiment 1 of the present invention Figure 1 ; Figure 13 Perspective view of the first reflective wing provided in Embodiment 1 of the present invention Figure 2 ; Figure 14 This is a partially enlarged schematic diagram of the energy-focusing forward shock waveguide provided in Embodiment 2 of the present invention; Figure 15 This is a three-dimensional structural diagram of the reflector assembly and the third fixed base provided in Embodiment 3 of the present invention. Figure 16 This is a three-dimensional structural schematic diagram of the third reflector provided in Embodiment 3 of the present invention; Figure 17 This is a perspective view of the third reflector provided in Embodiment 3 of the present invention; Figure 18 This is a three-dimensional structural diagram of the third fixing seat provided in Embodiment 3 of the present invention.

[0020] Icons: 1-Cadre body; 11-Guidewire cavity; 12-Shock wave generating cavity; 13-Fluid inlet; 14-Fluid outlet; 2-Fluid tube; 21-First inner tube body; 22-First fixing seat; 221-Through hole; 23-Second inner tube body; 24-Second fixing seat; 25-Third fixing seat; 3-Shock wave generating assembly; 31-Wire; 32-External electrode; 4-Reflector assembly; 41-First reflector; 411-First hinge hole; 412-Second hinge hole; 413-Avoidance structure; 414-L-shaped connecting arm; 42-Second reflector; 43-Third reflector; 5-Adjusting assembly; 51-First moving ring; 511-Connecting hole; 52-Connecting rod assembly; 53-Second moving ring; 54-Elastic element; 6-Operating assembly; 7-Guidewire; 8-Insulating ring. Detailed Implementation

[0021] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0022] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for 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. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0023] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; 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; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0024] The specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. It should be understood that the specific embodiments described herein are for illustration and explanation only and are not intended to limit the present invention. In this specification, "distal" refers to the end away from the operator during the surgical procedure, and "proximal" refers to the end closer to the operator during the surgical procedure.

[0025] This embodiment provides a forward shock waveguide for energy focusing, such as... Figures 1 to 3 As shown, it includes a conduit body 1, a fluid pipe 2, a shock wave generating assembly 3, a reflector assembly 4, and an adjustment assembly 5; The catheter body 1 includes an independently configured guidewire cavity 11 and a shock wave generating cavity 12, which are arranged parallel to each other along the axial direction. The fluid pipe 2, the reflector assembly 4, and the shock wave generating assembly 3 are all located inside the shock wave generating cavity 12. The shock wave generating assembly 3 is used to generate a shock wave toward the far end along the axial direction of the shock wave generating cavity 12. The reflector assembly 4 is located between the fluid pipe 2 and the shock wave generating assembly 3, and is located near the discharge position of the shock wave generating assembly 3. One end of the reflector assembly 4 is fixed relative to the fluid pipe 2 along the axial direction of the fluid pipe 2, and the other end is connected to the adjusting assembly 5. The adjustment component 5 slides along the axial direction of the fluid pipe 2 and is configured to adjust the angle between the reflector assembly 4 and the fluid pipe 2 to adjust the shock wave focusing performance.

[0026] In this embodiment, the forward shockwave catheter with focused energy is used such that the guidewire 7 passes through the guidewire lumen 11, and the operator advances the forward shockwave catheter along the guidewire 7 to the target calcified lesion site. Once the distal end of the catheter body 1 reaches the lesion, the angle between the reflector assembly 4 and the fluid tube 2 can be adjusted by changing the axial position of the adjustment component 5 relative to the fluid tube 2, thereby changing the focusing degree of the shockwave. For example, for refractory calcified lesions, increasing the angle between the reflector assembly 4 and the fluid tube 2 allows the reflector assembly 4 to focus the scattered energy and break down the refractory calcified lesion; for lesions with milder calcification, decreasing the angle between the reflector assembly 4 and the fluid tube 2 reduces energy focusing and lowers the risk of vascular injury.

[0027] Therefore, the aforementioned forward shock wave duct is equipped with an adjustment component 5 and a reflector component 4. The adjustment component 5 can adjust the angle between the reflector component 4 and the fluid tube 2, so that the shock wave focusing performance can be dynamically adapted to different calcification morphologies within the required range, which is beneficial for targeted disintegration of lesions with different degrees of calcification.

[0028] Furthermore, the aforementioned forward shock wave duct is independently configured with guide wire cavity 11 and shock wave generating cavity 12, effectively avoiding the shielding effect of the metal guide wire 7 on the electric field distribution and the obstruction of the shock wave propagation path, ensuring that the forward shock wave can be released directionally without interference, significantly improving energy utilization efficiency and discharge stability. The aforementioned dual-cavity layout also provides ample space for the adjustment component 5, enabling remote and controllable adjustment of the focusing degree.

[0029] Depending on the different structures of the reflector assembly 4 and the adjustment assembly 5, the following three embodiments can be specifically identified: Example 1 In this first embodiment, as Figure 4 As shown, the adjustment assembly 5 includes a first moving ring 51 and a connecting rod assembly 52. ​​The inner end of the reflector assembly 4 along the radial direction of the fluid pipe 2 is hinged to the fluid pipe 2, and the hinge axis is perpendicular to the axis of the fluid pipe 2. The outer end of the reflector assembly 4 along the radial direction of the fluid pipe 2 is hinged to one end of the connecting rod assembly 52, and the other end of the connecting rod assembly 52 is hinged to the first moving ring 51. The first moving ring 51 slides along the axial direction of the fluid pipe 2.

[0030] During use, when the first moving ring 51 is displaced along the axial direction of the fluid pipe 2, such as Figure 4 and Figure 5 As shown, the reflector assembly 4 will be rotated via the connecting rod group 52, thereby adjusting the angle between the reflector assembly 4 and the fluid pipe 2.

[0031] In this first embodiment, as Figure 2 As shown, the fluid pipe 2 includes a first inner pipe body 21 and a first fixing seat 22. The first fixing seat 22 is embedded in the outer pipe wall of the first inner pipe body 21, and the inner end of the reflector wing assembly 4 is hinged to the rotating shaft on the first fixing seat 22.

[0032] The aforementioned first fixing seat 22 is an annular metal bracket, embedded in the polymer tube wall at the front end of the first inner tube 21. It can be fixed by means of bonding / forging to have sufficient mechanical strength to support multi-point hinges.

[0033] The hinge structure between the reflector assembly 4 and the first fixed base 22 allows the reflector assembly 4 to swing ±45° around the pivot, achieving a continuous transition from the "folded" to the "deployed" state. The two ends of the pivot are pressed into the blind holes of the first fixed base 22 and spot-welded to prevent them from falling off. At the same time, a small gap is reserved between the pivot and the reflector assembly 4 to ensure flexible rotation without loosening.

[0034] In this first embodiment, to facilitate adjustment of the position of the first moving ring 51 relative to the fluid pipe 2, such as... Figures 6 to 9 As shown, the first moving ring 51 has at least one connecting hole 511, and the first fixed seat 22 has a through hole 221 that corresponds one-to-one with the connecting hole 511 along the axial direction of the fluid pipe 2; the adjusting assembly 5 also includes a first traction wire, which passes through the through hole 221 and is fixedly connected to the connecting hole 511.

[0035] The first traction wire can be a nickel-titanium alloy wire with high elastic modulus. The number of traction wires is 1-8. The distal end of the first traction wire passes through the through hole 221 and is fixed by laser welding, pressing or bonding to the connecting hole 511. The proximal end passes through the shock wave generating cavity 12 and extends to the operating component 6 located at the proximal end of the forward shock wave catheter. During the operation, the displacement of the first traction wire can be controlled by the operating component 6.

[0036] In this first embodiment, as Figure 10 As shown, the reflector assembly 4 includes a plurality of first reflectors 41, each of which is distributed sequentially along the circumference of the fluid pipe 2, and the inner side of the first reflector 41 is hinged to the outer wall of the fluid pipe 2 by a pin.

[0037] Specifically, such as Figure 11 As shown, two L-shaped connecting arms 414 are integrally formed or laser-cut into the central region of the outer edge of the first reflector 41. One side of each arm is connected to the body of the first reflector 41, and the other side extends away from the first reflector 41 and has a pin hole. They are hinged to the first moving ring 51 through a connecting rod assembly 52. ​​The connecting rod assembly 52 may include multiple connecting rods corresponding one-to-one with the first reflector 41. Both ends of the connecting rods are machined with ball heads or pin structures. One end of each connecting rod is hinged to the first moving ring 51, and the other end is hinged to the L-shaped connecting arm 414 corresponding to the first reflector 41, forming a two-degree-of-freedom hinge connection.

[0038] The connecting rod is preferably made of 316L stainless steel and is annealed to improve its flexibility and prevent fatigue fracture during repeated movements.

[0039] The first moving ring 51 is an annular sleeve made of medical-grade titanium alloy or PEEK polymer reinforced ring, with an inner diameter slightly larger than the outer diameter of the fluid tube 2. The first moving ring 51 is sleeved on the outer wall of the fluid tube 2 and can slide axially on the surface of the fluid tube 2 with a stroke of 2.0±0.1 mm. A low-friction coating (such as polytetrafluoroethylene or diamond-like carbon film) is provided between the inner ring of the first moving ring 51 and the outer wall of the fluid tube 2 to ensure smooth sliding and friction <0.05 N. Four protrusions are evenly distributed axially at the distal end of the first moving ring 51, and each protrusion has connecting holes on both sides of its circumference for connecting the pins and other hinge structures at the end of the connecting rod.

[0040] In this first embodiment, the first reflector 41 is made of shape memory alloy, and the specific material selection is as follows: The reflector material can include high acoustic impedance metals (such as stainless steel, nickel-cobalt alloy, nickel-titanium alloy, etc.). Taking nickel-titanium alloy as an example, according to the acoustic reflection efficiency formula, the energy reflection coefficient R of the shock wave at the interface of two media is about 0.87.

[0041] Thermomechanical training can improve structural stability, not only increasing the recovery rate but also serving as a key step in regulating martensitic phase transformation behavior. Its purpose is to induce the formation of a stable R phase, reduce phase transformation hysteresis, and improve cycle consistency, resulting in a shape recovery rate >99.5%. 7 The decay rate per cycle is less than 5%.

[0042] During the transition from the contracted state to the deployed state, the rotation angle of each first reflective wing 41 around its root hinge can be from 30° to 60°, preferably about 52°. The above angle range is determined by joint simulation of geometric optics and acoustic reflection, which can ensure that the reflective surface is accurately shaped at the target parabolic position, thereby enabling the shock wave from the electrode to be efficiently reflected and focused on the calcified area of ​​the blood vessel wall.

[0043] When the rotation angle θ is less than 30°, the flaps fail to fully unfold, resulting in a reduction of more than 15% in the effective reflective area, and the local normal angle deviates significantly from the design value, causing significant scattering. When the angle exceeds 60°, although the reflective area is saturated, edge warping causes secondary diffraction, which in turn reduces the focusing accuracy.

[0044] By controlling the laser cutting path and the currently mature thermomechanical training process, NiTi alloys can achieve a 60° large-angle rotation while the local maximum strain is less than 6%, which is far below its fatigue damage threshold, ensuring reliability for millions of cycles.

[0045] Specifically, the first reflective wing 41 can be made of nickel-titanium alloy. During manufacturing, the nickel-titanium alloy first reflective wing 41 undergoes a mature heat treatment process to achieve its natural folded posture, deploying upon entering the human body. In use, the reflection angle of the first reflective wing 41 can be changed by controlling the first traction wire.

[0046] To assess whether the maximum bending strain of the first reflector 41 at a bending angle of 90° is within the recoverable range, its maximum surface strain is calculated: ε max = t / 2R Where t is the average thickness of the first reflector 41; R is the radius corresponding to the outer arc of the first reflector 41; Substitute the value: ε max ≈7.5% This indicates that the maximum strain is 7.5%, which is less than the typical hyperelastic limit of NiTi alloys (about 8%), and therefore falls within the fully recoverable range.

[0047] Definition and measured reference values ​​of rebound rate: The rebound rate is defined as: Rebound rate = (θ) initia l-θ residual ) / θ initial ×100%; Where θ initia l is the deployment angle of the first reflector 41, θ residual The residual deformation angle of the first reflector 41.

[0048] Assuming the unfolding angle is 60° and the residual deformation angle is less than 1.1°, then: Rebound rate > (60° - 1.1°) / 60° × 100% = 98% Calculation of maximum working stress: The maximum bending stress occurs on the outer side of the root: σ max = My / I b = (F·d)·(t / 2) / I b ; Simplified to pure bending: σ max = E·t / 2R ≈500MPa Where, σ max d is the maximum bending stress; F is the applied external force (the axial thrust of the connecting rod); d is the lever arm length from the point of application of the external force to the root of the hinge; t is the average thickness of the first reflector 41; E is the elastic modulus; I b M is the moment of inertia of the cross section at the root of the first reflector 41; M is the bending moment of the cross section at the root of the first reflector 41; y is the distance from the neutral axis at half the thickness of the first reflector 41 to the outer side of the root of the first reflector 41.

[0049] 3) Fatigue limit of NiTi alloy (37°C) Medical-grade NiTi under R=-1 (completely reverse loading) conditions, 10 7 The fatigue limit for each cycle is approximately 400–600 MPa; In this application, uniaxial bending loading (R≈0) is applied, resulting in higher fatigue strength; Each loading cycle is short (<2 s), belonging to a low-frequency cycle (<<1 Hz), far from the resonance region. Therefore, 50 cycles are far below the material fatigue threshold and will not induce crack initiation.

[0050] Therefore, the first reflective wing 41, made of nickel-titanium alloy, exhibits stable hyperelastic behavior under physiological conditions at 37°C after heat setting. Theoretical calculations show that when the reflective wing is deployed to 90°, the maximum bending strain at the root of the first reflective wing 41 is 7.5%, lower than the 8% recoverable strain limit of NiTi alloy, ensuring fully elastic deformation. Dynamic simulation and in vitro testing confirm that after the traction force is released, the reflective wing can automatically retract to its initial shape within 1.5 seconds using its own elastic restoring force, with a rebound rate exceeding 98%. Furthermore, based on SN fatigue curves and finite element analysis, the structure shows no significant plastic deformation or microcracks after 50 deployment-contraction cycles, meeting the durability requirements of disposable medical devices.

[0051] It should be noted that the weight of the first moving ring 51 is much less than the frictional resistance and structural constraint force between it and the fluid pipe 2. Therefore, the reflector assembly 4 will not deploy unexpectedly due to changes in body position or gravity. All movements are actively controlled by the first traction wire, ensuring the safety and repeatability of the operation.

[0052] In this first embodiment, as Figure 12 and Figure 13 As shown, the first reflector 41 is provided with a first hinge hole 411 and a second hinge hole 412 for mounting a pin. The central axis of the first hinge hole 411 is eccentrically set relative to the central axis of the second hinge hole 412.

[0053] During installation, the inner side of the first reflector 41 is hinged to a pin fixed on the first mounting base 22. The pin is cylindrical, and its axis coincides with the central axis of the second hinge hole 412. Figure 13 As shown, the central axis of the first hinge hole 411 is closer to the proximal end of the fluid tube 2 and farther away from the axis of the fluid tube 2 than the central axis of the second hinge hole 412.

[0054] The above configuration allows the first reflective wing 41 to be deployed such that, due to the eccentric arrangement of the first hinge hole 411, it can... Figure 13 As shown, the pin will apply a contraction force F to the first reflector 41 through the first hinge hole 411. When the first traction wire cancels the external force applied to the first reflector 41 through the first moving ring 51 and the connecting rod group 52, the contraction force F will force the first reflector 41 to rotate clockwise by a certain angle, thereby realizing the contraction of the first reflector 41, reducing the angle between the first reflector 41 and the fluid pipe 2, and waiting for the next deployment.

[0055] In this first embodiment, the first reflective wing 41 extends further away from the fluid pipe 2 along the radial direction of the fluid pipe 2 and toward the far end of the fluid pipe 2. When fully deployed, each first reflective wing 41 forms a bowl-like structure.

[0056] like Figure 10 As shown, there are four first reflective fins 41, evenly and symmetrically distributed at 90° around the circumference of the fluid pipe. Micro-gaps are provided between adjacent first reflective fins 41, and the included angle between adjacent first reflective fins 41 is 90° to ensure balanced force during deployment and prevent uneven loading that could cause the fluid pipe to bend or become stuck. Figure 12 As shown, each first reflective wing 41 is an arc-shaped structure with an arc length of approximately 2.5 mm and a radius of curvature of approximately 2 mm. The arc length corresponds to a central angle of approximately 80°–90°. The edges are rounded (R≥0.05 mm) to reduce the risk of blood flow disturbance and endothelial damage.

[0057] In this first embodiment, as Figure 11 and Figure 12As shown, the first reflector 41 has a clearance structure 413 on both sides of its circumference. The clearance structure 413 on one side is located at the end of the side closest to the connecting rod assembly 52, and the clearance structure 413 on the other side is located at the end of the side furthest from the connecting rod assembly 52.

[0058] The aforementioned avoidance structure can be seen as the first reflector 41 having its upper edge chamfered on one side and its lower edge chamfered on the other side, thus forming the avoidance structure 413.

[0059] The above embodiments ensure the adjustment effect of the multi-lobed structure on the shock wave performance during repeated folding and unfolding by using the small gap between adjacent first reflective wings 41, the design of the avoidance structure 413, and the bowl-shaped structure design after the reflective wing assembly 4 is unfolded.

[0060] It should be noted that, Figure 5 The diagram shown is only for the purpose of understanding the retracted state of the reflector assembly 4. In actual use, each of the first reflectors 41 will have wrinkles in the retracted state.

[0061] Example 2: In this second embodiment, as Figure 14 As shown, the adjustment assembly 5 includes a second moving ring 53 and an elastic element 54; the second moving ring 53 slides along the axial direction of the fluid pipe 2 and is slidably engaged with the fluid pipe 2, and the elastic element 54 is disposed between the second moving ring 53 and the fluid pipe 2, and the elastic element 54 is used to apply a restoring force to the second moving ring 53 to move toward the fluid pipe 2; the reflector wing assembly 4 is connected to the second moving ring 53 along the radial inner side of the fluid pipe 2, and the reflector wing assembly 4 is connected to the inner side of the external electrode 32 in the shock wave generating assembly 3 along the radial outer side of the fluid pipe 2.

[0062] In use, the second moving ring 53 is dragged towards the proximal end by the second traction wire. At this time, the elastic element 54 is squeezed. Under the drag of the second moving ring 53, the reflector assembly 4 changes the angle with the fluid pipe 2, thereby adjusting the magnitude of the shock wave energy.

[0063] In this second embodiment, the fluid tube 2 includes a second inner tube body 23 and a second fixing seat 24. The second fixing seat 24 is embedded in the outer tube wall of the second inner tube body 23. The second fixing seat 24 may be provided with a through hole for the second traction wire to pass through. The distal end of the second traction wire is fixedly connected to the second moving ring 53.

[0064] The elastic element 54 can be disposed between the second moving ring 53 and the second fixed seat 24. When the second traction wire releases the force on the second moving ring 53, the elastic element releases the elastic force, causing the second moving ring 53 to reset.

[0065] The aforementioned elastic element 54 can be a spring.

[0066] In this second embodiment, the reflector assembly 4 includes a plurality of second reflectors 42, each of which is a flexible component and has a metal reflective layer on one side along the axial direction of the fluid pipe 2.

[0067] Specifically, the second reflective wing 42 employs a flexible reflective film structure, which includes a polymer substrate (such as polyimide or PET) and a vacuum-deposited metal reflective layer (preferably gold or aluminum, with a thickness of 0.5–2 μm) on one side surface. The flexible reflective film is recessed towards the proximal end of the fluid tube 2. By adjusting the axial position of the second moving ring 53, the flexible reflective film can exhibit different curvatures, thereby adjusting the magnitude of the shock wave energy.

[0068] The aforementioned flexible reflective membrane possesses excellent flexibility, acoustic reflection performance, and biocompatibility, and does not require a complex hinge mechanism, which helps reduce manufacturing costs and improve the overall reliability of the shock wave duct.

[0069] Example 3 In this third embodiment, as Figure 15 As shown, the reflector assembly 4 includes a plurality of third reflectors 43 made of shape memory alloy. The third reflectors 43 are hinged to the fluid tube 2 along the radial inner side. The adjustment assembly 5 includes a plurality of third traction wires that are connected one-to-one with the plurality of third reflectors 43.

[0070] In the above embodiments, the reflector assembly 4 consists of multiple independently controllable third reflectors 43. Each third reflector 43 is connected to a proximal independent control channel via a dedicated third traction wire, enabling selective deployment and contraction of single or multiple lobes. For example, when a calcified plaque is detected in a certain quadrant of the blood vessel (e.g., the 1–3 o'clock direction), only the third traction wire at the corresponding position is controlled to deploy, forming an asymmetric energy reflection field. This preferentially focuses the shock wave energy on the calcified area, while applying lower energy to the relatively healthy contralateral blood vessel wall, thereby achieving true "targeted lithotripsy" treatment.

[0071] The multi-channel traction system can be integrated into a multi-degree-of-freedom manipulation component 6 and combined with intravascular imaging information for visual guidance, further improving the precision of treatment.

[0072] Specifically, such as Figure 15 As shown, after the third reflector 43 is deployed, it extends further away from the fluid pipe 2 along the radial direction of the fluid pipe 2, and towards the far end of the fluid pipe 2.

[0073] In this third embodiment, the fluid pipe 2 includes a third inner pipe body and a third fixing seat 25. The third fixing seat 25 is embedded in the outer pipe wall of the third inner pipe body, and the third reflective wing 43 is hinged to the third fixing seat 25 along the radial inner side.

[0074] Specifically, the reflector assembly has four arc-shaped third reflectors 43 (which can be expanded to six or even more), evenly distributed at 90° along the circumference of the duct; the material of each third reflector 43 can be a shape memory alloy.

[0075] When in use, pulling back the corresponding third traction wire causes the corresponding third reflector 43 to unfold; after releasing the third traction wire, the third reflector 43 naturally retracts.

[0076] Based on the above embodiments, the proximal end of the catheter body 1 is connected to an operating component 6, which is connected to an adjusting component 5 and drives the adjusting component 5 to slide along the axial direction of the fluid tube 2 via a traction ribbon.

[0077] Operating component 6 may include a knob and a pulley connected to the knob, with the traction wire wound around the pulley. Rotating the knob causes the pulley to wind the traction wire onto it or release the traction wire from the pulley. Alternatively, operating component 6 may include a slide rail and a slider that slides along the slide rail, with the traction wire connected to the slider. Of course, operating component 6 may also be electrically controlled, including an electric actuator, linear motor, or other driver capable of linear motion, to move the traction wire.

[0078] In Embodiment 3, the aforementioned operating component 6 can be configured in multiple ways. For example, multiple operating components 6 can be configured at the proximal end of the shockwave catheter, and each operating component 6 adopts an independent slide rail control structure. Each slide rail corresponds to a third traction wire and is equipped with a scale (0–2 mm displacement) and a limit buckle. The doctor can manually push and pull each slider to achieve any combination of the opening modes of the third reflector 43: single-lobe mode (e.g., only the first lobe); diagonal double-lobe mode (first and third lobes); adjacent double-lobe mode (first and second lobes); and fully deployed mode (all four lobes).

[0079] Based on the above embodiments, such as Figure 2 and Figure 3As shown, the shock wave generating component 3 can adopt an existing structure capable of emitting forward shock waves. For example, it can consist of two wires 31 (e.g., insulated copper wires). The wires 31 extend along the fluid tube inside the shock wave generating cavity and terminate near the distal end of the shock wave generating cavity 12. The two wires 31 include uninsulated end faces, one of which is connected to the positive terminal of the pulse high-voltage power supply, and the other is connected to the negative terminal of the pulse high-voltage power supply, generating a pulse voltage between the two wires. The shock wave generating component 3 can also include two inner electrodes and one outer electrode 32. The two inner electrodes are the two wires 31, and the outer electrode 32 can be a conductive cylinder, sleeved on the fluid tube 2 and the outside of the two wires 31, such that the outer electrode 32 is arranged around the ends of the two wires 31 without contacting them. An insulating ring 8 is provided between the outer electrode 32 and the reflector assembly 4. When a high-voltage pulse is applied to both ends of the two wires 31, current will flow from the uninsulated end of one wire to the outer electrode 32 to generate an arc, and then from the outer electrode 32 to the uninsulated end of the other wire to generate another arc. Ultimately, a shock wave is generated at the distal end of the catheter, which propagates through the conductive fluid and the catheter wall and impacts the occlusion or calcification.

[0080] The external electrode 32 may contain multiple wires 31. By adjusting the shock wave interval, high voltage pulses can be applied to the proximal end of the wires 31 to alternately generate shock waves, thereby further improving the efficiency of the catheter.

[0081] In an optional embodiment, the guidewire cavity 11 and the shock wave generating cavity 12 inside the catheter body 1 are made of polytetrafluoroethylene (PTFE) to ensure that the guidewire and other devices can slide smoothly in the corresponding guidewire cavity; at the same time, the outer surface of the catheter body 1 is provided with a functional coating, including but not limited to a lubricating coating, a hydrophilic coating, and an antibacterial coating.

[0082] In this system, a fluid conduit 2, located near the distal end of the shock wave generating chamber 12, draws conductive fluid from the internal volume, while a fluid pump (not shown) pumps additional conductive fluid in through a fluid inlet 13 at the proximal end of the main chamber. The fluid conduit 2 and the fluid pump circulate the pressurized conductive fluid within the internal volume, eventually discharging it from the fluid outlet 14. This circulation of the conductive fluid prevents air bubbles generated by the shock wave generating assembly 3 from being trapped in the distal end of the catheter body 1 due to the limited space within the distal end. Furthermore, the circulation of the conductive medium promotes cooling of the catheter body 1 and the treatment site.

[0083] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A forward shock waveguide for energy focusing, characterized in that, It includes a conduit body (1), a fluid tube (2), a shock wave generating assembly (3), a reflector assembly (4), and an adjustment assembly (5); The catheter body (1) includes an independently configured guidewire cavity (11) and a shock wave generating cavity (12), which are arranged parallel to each other along the axial direction; The fluid pipe (2), the reflector assembly (4), and the shock wave generating assembly (3) are all located inside the shock wave generating cavity (12). The shock wave generating assembly (3) is used to generate a shock wave toward the far end along the axial direction of the shock wave generating cavity (12). The reflector assembly (4) is located between the fluid pipe (2) and the shock wave generating assembly (3). One end of the reflector assembly (4) is fixed relative to the fluid pipe (2) along the axial direction of the fluid pipe (2), and the other end is connected to the adjusting assembly (5). The adjustment component (5) slides along the axial direction of the fluid tube (2) and is configured to adjust the angle between the reflector assembly (4) and the fluid tube (2) to adjust the shock wave focusing performance.

2. The energy-focusing forward shock waveguide according to claim 1, characterized in that, The adjustment assembly (5) includes a first moving ring (51) and a connecting rod assembly (52). The inner end of the reflector assembly (4) along the radial direction of the fluid pipe (2) is hinged to the fluid pipe (2), and the hinge axis is perpendicular to the axis of the fluid pipe (2). The outer end of the reflector assembly (4) along the radial direction of the fluid pipe (2) is hinged to one end of the connecting rod assembly (52), and the other end of the connecting rod assembly (52) is hinged to the first moving ring (51). The first moving ring (51) slides along the axial direction of the fluid pipe (2) with the fluid pipe (2).

3. The energy-focusing forward shock waveguide according to claim 2, characterized in that, The fluid pipe (2) includes a first inner tube body (21) and a first fixing seat (22). The first fixing seat (22) is embedded in the outer tube wall of the first inner tube body (21), and the inner end of the reflector assembly (4) is hinged to the first fixing seat (22).

4. The energy-focusing forward shock waveguide according to claim 3, characterized in that, The first moving ring (51) has at least one connecting hole (511), and the first fixed seat (22) has through holes (221) that correspond one-to-one with the connecting holes (511) along the axial direction of the fluid pipe (2). The adjustment assembly (5) further includes a first traction wire, which passes through the through hole (221) and is fixedly connected to the connection hole (511).

5. The energy-focusing forward shock waveguide according to claim 2, characterized in that, The reflector assembly (4) includes a plurality of first reflectors (41), each of which is made of shape memory alloy and is distributed sequentially along the circumference of the fluid tube (2); The inner end of the first reflector (41) is hinged to the pin on the outer wall of the fluid pipe (2). The first reflector (41) is provided with a first hinge hole (411) and a second hinge hole (412) for mounting the pin. The central axis of the first hinge hole (411) is eccentrically set relative to the central axis of the second hinge hole (412). The outer end of the first reflector wing (41) is hinged to the connecting rod assembly (52).

6. The energy-focusing forward shock waveguide according to claim 2, characterized in that, The reflector assembly (4) includes a plurality of first reflectors (41) which are distributed circumferentially along the fluid pipe (2); The first reflective wing (41) extends further away from the fluid pipe (2) along the radial direction of the fluid pipe (2) and toward the far end of the fluid pipe (2); And / or, both sides of the first reflector (41) are provided with a clearance structure (413), one side of which is located at the end of the side closest to the connecting rod group (52), and the other side of which is located at the end of the side furthest from the connecting rod group (52).

7. The energy-focusing forward shock waveguide according to claim 1, characterized in that, The adjustment assembly (5) includes a second moving ring (53) and an elastic element (54); The second moving ring (53) slides along the axial direction of the fluid tube (2) with the fluid tube (2), and an elastic element (54) is provided between the second moving ring (53) and the fluid tube (2). The elastic element (54) is used to apply a restoring force to the second moving ring (53) to move toward the distal end of the fluid tube (2). The inner end of the reflector assembly (4) along the radial direction of the fluid pipe (2) is connected to the second moving ring (53), and the outer end of the reflector assembly (4) along the radial direction of the fluid pipe (2) is connected to the shock wave generating assembly (3).

8. The energy-focusing forward shock waveguide according to claim 7, characterized in that, The reflector assembly (4) includes a plurality of second reflectors (42), each of which is a flexible member and has a metal reflective layer on one side along the axial direction of the fluid tube (2).

9. The energy-focusing forward shock waveguide according to claim 1, characterized in that, The reflector assembly (4) includes a plurality of third reflectors (43) made of shape memory alloy components. The third reflectors (43) are hinged to the fluid tube (2) along the radial inner side. The adjustment assembly (5) includes a plurality of third traction wires that are connected one-to-one with the plurality of third reflectors (43).

10. The energy-focusing forward shock waveguide according to any one of claims 1-9, characterized in that, An operating component (6) is connected to the proximal end of the catheter body (1). The operating component (6) is connected to the adjustment component (5) and is used to drive the adjustment component (5) to slide along the axial direction of the fluid tube (2).

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