Adjustable intravascular shockwave catheter

Abstract

This invention relates to the field of medical catheter technology, specifically disclosing an adjustable intravascular shockwave guidewire, comprising a guidewire body with a emitting tip at its distal end. An adjustment assembly is located outside the guidewire body and near the emitting tip. The adjustment assembly includes a movable sleeve axially slidably fitted outside the guidewire body and near the emitting tip. An adjustment mesh frame is located outside the movable sleeve. The adjustment mesh frame has a hollow mesh structure, with both ends converging and fixed to the guidewire body. The movable sleeve is connected to the inner wall of the adjustment mesh frame via a wire support assembly. When the movable sleeve moves axially, the wire support assembly pulls the inner wall of the adjustment mesh frame, forcing the adjustment mesh frame to undergo radial outward arching deformation or axial bending deflection deformation under the constraint of its fixed ends. This deformation of the adjustment mesh frame supports the vessel wall, thereby adjusting the position of the guidewire body on the vessel cross-section, thus greatly improving the guidewire's performance.

Description

Technical Field

[0001] This invention relates to the field of medical catheter technology, and more specifically, to an adjustable intravascular shock waveguide wire. Background Technology

[0002] Vascular calcification is a common challenge in interventional cardiovascular treatment, severely limiting vascular compliance. This is especially true for chronic total occlusion (CTO), where the lumen is completely blocked by a hard calcified cap, making it difficult for conventional guidewires to pass through. Specialized shock wave or ablation techniques are often required to open the occluded segment. Intravascular shock wave (IVL) technology utilizes high-energy shock waves generated by electrodes discharging in a liquid medium to effectively fracture deep calcified plaques. In clinical applications, guidewire devices integrating shock wave emission capabilities are frequently used to treat such complex stenosis or occlusion due to their extremely small profile and excellent passageability.

[0003] However, existing intravascular shockwave guidewires have significant limitations in actual clinical use. Because the diameter of the shockwave guidewire is usually much smaller than the inner diameter of the blood vessel lumen, this significant radial dimensional difference causes the guidewire to be naturally in a "non-concentric" state on the blood vessel cross-section. At the same time, affected by gravity, blood flow impact, and the anatomical orientation of the blood vessel, the guidewire tends to float in the center of the lumen or randomly adhere to one side of the blood vessel's bend after entering the blood vessel. It is difficult for the operator to actively control its specific position and adhesion direction on the blood vessel cross-section.

[0004] This uncontrollability of position is particularly prominent when treating common eccentric calcified lesions. Because the energy of the shock wave attenuates rapidly with increasing distance as it propagates in the blood medium, if the guidewire cannot overcome the concentricity deviation with the blood vessel to closely adhere to the vessel wall on the lesion side, the emitted energy will not be effectively focused on the calcification, resulting in low treatment efficiency. Since there is a lack of effective adjustment methods to correct this positional deviation in current technology, and due to the lack of efficient thermal management mechanisms limited by the micro-size, clinical practice often has to compensate for distance loss by increasing the discharge energy or extending the discharge time, but this greatly increases the risk of intravascular thermal damage and thrombosis.

[0005] Therefore, this solution proposes an adjustable intravascular shock waveguide wire. Summary of the Invention

[0006] In order to overcome the above-mentioned defects of the prior art, the present invention provides an adjustable intravascular shock waveguide wire to at least solve one of the problems mentioned in the background art.

[0007] To achieve the above objectives, the present invention provides the following technical solution:

[0008] An adjustable intravascular shockwave guidewire includes a guidewire body, a emitting tip at the distal end of the guidewire body, and an adjustment assembly located outside the guidewire body and near the emitting tip.

[0009] The adjustment assembly includes a movable sleeve axially slidably fitted outside the guidewire body and near the firing tip. An adjustment mesh frame is provided on the outside of the movable sleeve. The adjustment mesh frame has a hollow mesh structure, and its two ends are closed and fixed to the guidewire body. The movable sleeve is connected to the inner wall of the adjustment mesh frame through a wire support assembly. When the movable sleeve moves axially, the inner wall of the adjustment mesh frame is pulled by the wire support assembly, forcing the adjustment mesh frame to undergo radial outward arching deformation or axial bending deflection deformation under the constraint of fixed ends. The deformed adjustment mesh frame supports the blood vessel wall, thereby adjusting the position of the guidewire body on the blood vessel cross section.

[0010] Furthermore, the movable sleeve includes multiple arc-shaped sliding plates that are sequentially spliced ​​together along the circumferential direction to form a tubular shape. Each arc-shaped sliding plate is independently slidably fitted onto the outer wall of the guide wire body. The wire support assembly includes a front support wire and a rear support wire respectively provided for each arc-shaped sliding plate.

[0011] One end of the front support wire is connected to the outside of the arc-shaped slide plate near the launch tip, and the other end is connected to the inner wall of the adjustment frame near the launch tip. One end of the rear support wire is connected to the outside of the arc-shaped slide plate away from the launch tip, and the other end is connected to the inner wall of the adjustment frame away from the launch tip.

[0012] Furthermore, the adjustment assembly also includes an adjustment seat located outside the guidewire body and away from the firing tip. Inside the adjustment seat is a transmission cable corresponding to the arc-shaped sliding plate. The distal end of the transmission cable extends along the axial direction of the guidewire body and is connected to the arc-shaped sliding plate. Outside the adjustment seat is an adjustment knob corresponding to the transmission cable. At the bottom of the adjustment knob is a coil extending into the interior of the adjustment seat. The proximal end of the transmission cable inside the adjustment seat is wound around the outside of the coil.

[0013] Furthermore, each of the adjacent arc-shaped sliding plates is provided with a sliding member at the circumferential splicing sidewall. The sliding member includes a plurality of transition guide blocks that extend axially and are fixedly protruding on the outer wall of the guide wire body. Each transition guide block is located between two adjacent arc-shaped sliding plates. A guide groove extending axially is provided on each of the two side walls of the transition guide block. A guide tongue extending inward and adapted to be embedded in the guide groove is provided on the circumferential side edge of each arc-shaped sliding plate.

[0014] Furthermore, a locking release assembly corresponding to the adjustment knob is provided inside the adjustment seat. The locking release assembly includes a ratchet disc coaxially disposed outside the lever, a pawl located on one side of the ratchet disc and abutting against it, and a rotating rod rotatably extending through the upper part of the pawl to the outside of the adjustment seat. A return torsion spring is sleeved at the position where the rotating rod passes through the outside of the lever body of the adjustment seat. One end of the return torsion spring abuts against the adjustment seat, and the other end is connected to the rotating rod.

[0015] Furthermore, a flexible protective tube is coaxially sleeved outside the guide wire body and located between the adjusting mesh frame and the adjusting seat, and the transmission cable passes through the interior of the flexible protective tube.

[0016] Furthermore, a guide head is provided at the end of the emitting tip away from the guide wire body. The outer contour of the emitting tip gradually narrows into an inward concave arc from the guide head to the guide wire body and forms a spindle structure. A conductive connector is also provided at the proximal end of the guide wire body. The conductive connector is connected to the emitting tip through a wire passing through the guide wire body.

[0017] Furthermore, a spirally wound cooling tube is provided on the outside of the firing tip. The two ends of the cooling tube are respectively connected to the cooling circulation pipe inside the guide wire body. A coolant injection seat is also provided on the outside of the guide wire body near the conductive connector. The coolant injection seat has an injection port and an outlet on both sides that are connected to the cooling circulation pipe.

[0018] Furthermore, the cooling pipe has a D-shaped cross-section and has a planar fitting wall facing inward and an arc-shaped outer wall facing outward. A drainage groove is formed inside the planar fitting wall of the cooling pipe.

[0019] Furthermore, the transition guide block has multiple development marking points on its exterior, and these multiple development marking points are arranged sequentially at intervals along the axial direction of the transition guide block. The arc-shaped slide plate has development indicator blocks corresponding to the development marking points.

[0020] Compared with the prior art, the technical effects and advantages of the present invention include at least the following:

[0021] 1. This invention utilizes a modular adjustment assembly consisting of multiple independent arc-shaped sliding plates and corresponding support wires to achieve independent zoned control of the deformation shape of the adjustment mesh. During use, it can construct a directional non-uniform support force for the asymmetrical anatomical environment within blood vessels, actively counteracting lateral thrust and forcing the deviated guidewire body to radially return and lock in the geometric center of the lumen, thereby ensuring that the firing tip is accurately aligned with the core of the lesion. This solves the technical problem that the guidewire is prone to slipping into false channels or perforation in complex paths.

[0022] 2. This invention designs the firing tip as a spindle structure with a concave arc transition, which takes into account both energy utilization and mechanical passage performance. It guides electrical energy to be released in a high-density concentration at the tip to improve membrane rupture efficiency. The streamlined sidewall of the spindle plays a role in smooth expansion and low-resistance wedging during advancement. Combined with the blunt design of the front guide head, it effectively reduces the frictional resistance during passage, ensuring that the instrument can smoothly pass through high-resistance lesion areas without damaging the tube wall.

[0023] 3. This invention achieves efficient circulating cooling and heat dissipation by embedding a cooling pipe with a D-shaped cross-section and internal drainage groove in the spiral groove of the launch tip. The planar contact wall of the D-shaped cross-section maximizes the heat conduction contact area with the metal substrate, and the internal groove induces local turbulence in the fluid to destroy the laminar boundary layer, which greatly improves the convective heat transfer efficiency, ensures thermal stability during high-frequency operation, and effectively prevents vascular thermal damage or surface bio-adhesion caused by high temperature.

[0024] 4. This invention solves the problem of shrinkage and instability caused by the superelasticity of nickel-titanium alloy space frame by setting a locking and release component with ratchet disc and pawl in the adjustment seat. When tightening the cable, the coil rod is automatically locked to maintain the support shape of the space frame stably without continuous force. When the use ends, it supports one-key release and automatically restores the straight state by using the rebound force of the space frame, ensuring the stability of the operation process and the convenience of withdrawal.

[0025] 5. This invention establishes a visual position feedback mechanism by setting corresponding development marks and indicator blocks on the transition guide block and the arc-shaped slide. During use, the deformation state of the remote adjustment frame is clearly displayed, allowing the operator to accurately know the current opening size and support status, avoiding over-opening or insufficient support caused by blind operation, and significantly improving the controllability of operation accuracy. Attached Figure Description

[0026] Figure 1 This is a schematic diagram of the overall structure of the guidewire of the present invention;

[0027] Figure 2 This is a partial structural diagram of the movable sleeve of the present invention, intended to illustrate the state of the arc-shaped sliding plate;

[0028] Figure 3 This is a partial cross-sectional structural diagram of the adjustment component of the present invention;

[0029] Figure 4 This is a schematic diagram of the arc-shaped sliding plate and transition guide block of the present invention;

[0030] Figure 5 This is a schematic diagram of the internal structure of the adjusting seat of the present invention;

[0031] Figure 6 This is a partially enlarged structural diagram of the locking and releasing component of the present invention;

[0032] Figure 7 This is a schematic diagram of the mating structure of the ratchet disc and pawl of the present invention;

[0033] Figure 8 This is a schematic diagram of the usage state of the adjustable grid frame of the present invention;

[0034] Figure 9 This is a partial structural diagram of the firing tip of the present invention.

[0035] In the above figures, the reference numerals are as follows: 1. Guide wire body; 2. Emission tip; 21. Cooling tube; 3. Adjustment assembly; 31. Moving sleeve; 311. Arc-shaped sliding plate; 32. Adjustment frame; 331. Front support wire; 332. Rear support wire; 34. Adjustment seat; 341. Adjustment knob; 342. Winding rod; 35. Transmission cable; 36. Transition guide block; 361. Guide groove; 362. Guide tongue; 371. Ratchet; 372. Pawl; 373. Rotating rod; 374. Torsion spring; 381. Developing mark point; 382. Developing indicator block; 4. Conductive connector; 5. Coolant injection seat. Detailed Implementation

[0036] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to embodiments. The illustrative embodiments and descriptions of this invention are for illustrative purposes only and are not intended to limit the invention. The embodiments described below are some, but not all, of the embodiments of this invention. All other embodiments obtained by those skilled in the art based on the embodiments of this invention without creative effort are within the scope of protection of this invention.

[0037] Furthermore, in the description of this application, "multiple" means two or more, unless otherwise explicitly specified.

[0038] Example:

[0039] This embodiment provides an adjustable intravascular shockwave guidewire. Obviously, this guidewire is a medical device used in the field of vascular intervention, especially for treating severe calcified lesions or chronic total occlusion (CTO) lesions in blood vessels. Specifically, it is usually inserted into the human blood vessel cavity through a subcutaneous puncture and pushed to the stenosis of the lesion to use the shockwave energy released from the tip to crush or loosen the hard calcified tissue. At the same time, the guidewire itself provides support to establish a working track for the delivery of subsequent devices such as balloons and stents.

[0040] Please see Figure 1As shown, its structure specifically includes a guidewire body 1, the distal end of which has a firing tip 2, and an adjustment component 3 located on the outside of the guidewire body 1 and near the firing tip 2.

[0041] The adjustment assembly 3 includes a movable sleeve 31 axially slidably sleeved outside the guidewire body 1 and located near the firing tip 2. An adjustment mesh frame 32 is provided outside the movable sleeve 31. The adjustment mesh frame 32 has a hollow mesh structure, and its two ends are closed and fixed to the guidewire body 1. The movable sleeve 31 is connected to the inner wall of the adjustment mesh frame 32 through a wire support assembly. When the movable sleeve 31 moves axially, the inner wall of the adjustment mesh frame 32 is pulled by the wire support assembly, forcing the adjustment mesh frame 32 to undergo radial outward arching deformation or axial bending deflection deformation under the constraint of fixed ends, so as to support the blood vessel wall through the deformed adjustment mesh frame 32 and thereby adjust the position of the guidewire body 1 on the blood vessel cross section.

[0042] When performing interventional treatment for chronic total occlusion (CTO) lesions, guidewire path control is crucial. Because the diameter of the guidewire body 1 is much smaller than the inner diameter of the blood vessel, it naturally lacks centering support within the vessel. As is common in complex situations seen in clinical angiography, there are often asymmetrical microcalcified plaques or anatomical distortions of the vessel wall at the anterior end of the CTO occlusion segment. This asymmetrical vascular geometry causes the guidewire to be subjected to uneven lateral compression during advancement, forcing the guidewire's central axis to deviate from the anatomical centerline of the vessel and preventing it from being aligned with the center of the CTO lesion behind it. Existing shockwave guidewires lack the ability to actively correct this path deviation, causing the firing tip 2 to often point obliquely towards the vessel sidewall rather than the core of the CTO occlusion segment. If mechanical advancement or shockwave firing is performed under these conditions, the guidewire is very likely to slip into the subintimal region, forming a false passage, or even perforating and damaging the vessel. At the same time, it is impossible to accurately apply shockwave energy to the hardest central region of the occlusion segment, seriously affecting the success rate of recanalization.

[0043] Therefore, it is understandable that, based on the above solution, this embodiment solves the technical problem that the guidewire cannot actively calibrate its central path in complex vascular anatomy by setting an adjustment component 3 outside the guidewire body 1 and using the axial displacement of the movable sleeve 31 to drive the wire support component, thereby pulling the adjustment frame 32 to produce controlled morphological changes. Specifically, when the movable sleeve 31 moves axially, it pulls the inner wall of the adjustment frame 32 through the wire support component, thereby forcing the adjustment frame 32, which is fixed at both ends, to undergo radial arching or deflection deformation, thereby changing the contact relationship between the frame and the vessel wall.

[0044] For example, in practical applications, especially when dealing with asymmetric calcified plaques preceding CTO lesions, the operator drives the movable cannula 31 to perform axial displacement, applying tension to the adjusting mesh 32 via the strut assembly. During this process, the adjusting mesh 32 does not passively conform to the malformed shape of the vessel, but rather, under the pull of the strut assembly, generates a non-uniform interaction force with the vessel wall: that is, on the side farther from the lesion plaque (the side with more space), the mesh is fully expanded and provides stronger rigid support; while on the side closer to the lesion plaque, the mesh is constrained by the reaction force, forming a locally compressed or evasive shape, thus utilizing this... The differentiated support shape formed by the moving cannula 31 allows the adjusting mesh frame 32 to effectively counteract the lateral thrust of the pre-positioned plaque on the guidewire, forcing the guidewire body 1 and the emitting tip 2, which are in an off-center state, to radially return to their original position on the vascular cross-section, recalibrate and lock into the geometric center position of the vascular lumen (i.e., the centered state in the CTO lesion area). Through this active correction and centering adjustment, it is ensured that the emitting tip 2 is always directly facing the central core area of ​​the CTO lesion, thereby establishing a precise opening path. This ensures both the efficient utilization of shock wave energy and minimizes the risk of guidewire deviation damaging the vascular wall.

[0045] In some embodiments, Figure 1 As shown in the diagram, the adjusting mesh frame 32 is constructed as a mesh-like braided tube formed by multiple interwoven metal wires. To ensure that it maintains a stable structural shape during repeated expansion and contraction, the adjusting mesh frame 32 is preferably woven from nickel-titanium shape memory alloy wires and pre-heat-set into a spindle-shaped or streamlined profile that is thicker in the middle and thinner at both ends. On the one hand, the superelasticity of the nickel-titanium alloy wires gives the mesh frame excellent radial restoring force, enabling it to respond quickly and produce the expected deformation when driven by the wire support assembly. After the external force is removed, it can automatically retract to a low-profile state that conforms to the guide wire body 1, which is beneficial for passing through stenotic lesions. On the other hand, the mesh-like braided structure has good flexibility. When it expands and abuts against the blood vessel wall, the dense metal mesh can evenly distribute the supporting pressure on the contact surface of the blood vessel inner wall, avoiding mechanical damage to the blood vessel intima caused by excessive local pressure.

[0046] In addition, as a preferred option, the surface of the adjustment frame 32 can also be covered with a flexible polymer film (such as a polytetrafluoroethylene PTFE film). The film design can not only further reduce the friction coefficient between the frame and the blood vessel wall and improve the push feel of the guide wire, but also effectively wrap the mesh of the metal braided wire to prevent the risk of cutting or clamping the plaque tissue on the inner wall of the blood vessel during the adjustment process. Thus, while ensuring the central support effect, the safety of the surgical operation is maximized.

[0047] Understandably, when faced with complex vascular conditions where there are asymmetrical microcalcified plaques at the front end of a CTO lesion, medical imaging equipment (such as angiography) is used to observe the position of the guidewire and the lesion. It is often found that the pressure of the preceding plaque or the influence of the vascular geometry causes the central axis of the guidewire body 1 to be not on the same horizontal line as the geometric center of the CTO lesion behind it (i.e., there is a radial positional deviation).

[0048] Therefore, this embodiment further proposes a preferred implementation method, please refer to [link / reference]. Figures 2 to 4 As shown, the movable sleeve 31 includes a plurality of arc-shaped sliding plates 311 that are sequentially spliced ​​along the circumferential direction to form a tubular shape. Each arc-shaped sliding plate 311 is independently slidably fitted to the outer wall of the guide wire body 1. The wire support assembly includes a front support wire 331 and a rear support wire 332 respectively provided for each arc-shaped sliding plate 311.

[0049] One end of the front support wire 331 is connected to the outside of the arc-shaped slide plate 311 near the launch tip 2, and the other end is connected to the inner wall of the adjustment frame 32 near the launch tip 2. One end of the rear support wire 332 is connected to the outside of the arc-shaped slide plate 311 away from the launch tip 2, and the other end is connected to the inner wall of the adjustment frame 32 away from the launch tip 2.

[0050] It should be noted that this solution designs the movable sleeve 31 as a split structure composed of multiple arc-shaped sliding plates 311 sequentially spliced ​​along the circumferential direction. Each arc-shaped sliding plate 311 is independently equipped with a front support wire 331 and a rear support wire 332 connected to the inner wall of the adjustment frame 32. Through this structural construction, this solution cleverly divides the adjustment frame 32 into multiple independently deformable adjustment areas in the circumferential direction, thereby achieving independent control of the deformation shape of the adjustment frame 32. This allows it to overcome the limitation of isotropic deformation of the integral structure of the adjustment frame 32 when facing asymmetrical internal vascular structures, and to construct a non-uniform support force with clear directionality.

[0051] Specifically, in practical applications, the operator selectively drives a specific arc-shaped slide plate 311 corresponding to the direction of deviation to move axially. At this time, since only the support wire assembly connected to this slide plate is under force, the adjusting frame 32 is pulled to undergo radial arching deformation in a specific circumferential orientation, while maintaining slight deformation or no deformation in other orientations. This asymmetrical deformation forms a directional lateral thrust within the blood vessel lumen. Utilizing the strong support on the side away from the lesion location (or the specific support side), the guidewire body 1 is forced to overcome the obstruction of the pre-existing plaque and radially return to its original position until the center of the guidewire coincides with the center of the CTO lesion, thereby achieving precise centered recanalization. Figure 8 As shown in the image.

[0052] In some embodiments, the number of the arc-shaped sliding plates 311 can be adaptively configured according to the size specifications of the guidewire and the specific clinical requirements for adjustment precision (e.g., two, three, or more). As a preferred embodiment, the number of the arc-shaped sliding plates 311 is specifically configured as three, and these three arc-shaped sliding plates 311 are evenly distributed at 120-degree intervals along the circumference of the guidewire body 1, thereby utilizing this triangular support layout to achieve 360° all-round adjustment and coverage of the guidewire body 1 within the blood vessel lumen.

[0053] In some embodiments, the front support wire 331 and the rear support wire 332 of the wire support assembly are preferably made of nickel-titanium shape memory alloy. The support wire made of this material possesses both suitable structural rigidity and superelasticity. On the one hand, it has sufficient mechanical strength to effectively support the adjustment mesh frame 32 during operation, preventing the mesh frame from collapsing or failing to transmit force due to excessive softness. On the other hand, its excellent elastic bending ability ensures the flexibility of the guidewire when passing through tortuous blood vessels, preventing rigid points from forming that could puncture the adjustment mesh frame 32 or damage the inner wall of the blood vessel due to excessive rigidity. This effectively balances strong support for the mesh frame with operational safety during intravascular operation.

[0054] As a further possible implementation of the above embodiments, such as Figure 5 As shown, the adjustment assembly 3 also includes an adjustment seat 34 located outside the guide wire body 1 and away from the firing tip 2. Inside the adjustment seat 34 is a transmission cable 35 corresponding to the arc-shaped slide plate 311. The distal end of the transmission cable 35 extends along the axial direction of the guide wire body 1 and is connected to the arc-shaped slide plate 311. Outside the adjustment seat 34 is an adjustment knob 341 corresponding to the transmission cable 35. The bottom of the adjustment knob 341 is provided with a coil rod 342 extending into the interior of the adjustment seat 34. The proximal end of the transmission cable 35 located inside the adjustment seat 34 is wound around the outside of the coil rod 342.

[0055] Through the aforementioned structural coordination, this embodiment converts the rotational motion applied externally by the operator into a linear traction force within the guidewire, thereby precisely driving the distal arc-shaped sliding plate 311 remotely. Specifically, in actual operation, the operator rotates the adjustment knob 341 on the outside of the adjustment seat 34, directly driving the bottom winding rod 342 to rotate synchronously, thereby winding up the transmission cable 35 wound on it. As the transmission cable 35 is tightened, its effective length shortens, thereby applying an axial pulling force to the distal arc-shaped sliding plate 311, dragging the arc-shaped sliding plate 311 to produce an axial sliding displacement along the outer wall of the guidewire body 1, and then driving the adjustment frame 32 to produce the expected shape change through the aforementioned wire support assembly, realizing independent and controllable adjustment of the guidewire tip posture.

[0056] It should be further explained that, in order to ensure that the arc-shaped sliding plate 311 can maintain a stable circumferential posture when it is independently slidably adjusted on the outer wall of the guidewire body 1, and to effectively avoid the situation where the sliding plate rotates (stirs) around the guidewire due to vascular tortuosity or external force interference, thereby causing the traction adjustment frame 32 of the wire support assembly to be ineffective or deformed in the wrong position, ultimately resulting in the guidewire tip not being accurately aligned or not being able to be aligned with the core of the lesion.

[0057] Therefore, this embodiment is a further preferred implementation method; please refer to [link / reference]. Figure 6 Sliding elements are specially provided at the circumferential splicing sidewalls of each adjacent arc-shaped slide plate 311. The sliding elements include multiple transition guide blocks 36 that extend axially and are fixedly protruding on the outer wall of the guide wire body 1. Each transition guide block 36 is located between two adjacent arc-shaped slide plates 311 and plays a role in physical isolation and positioning. At the same time, guide grooves 361 extending axially are respectively opened on the two side walls of the transition guide blocks 36, and guide tongues 362 extending inward and adapted to be embedded in the guide grooves 361 are provided on the circumferential side edges of each arc-shaped slide plate 311.

[0058] Understandably, in the above embodiments, this solution adds a transition guide block 36 fixed to the guide wire at the splicing gap between adjacent arc-shaped slide plates 311, and achieves axial guidance of the arc-shaped slide plate 311 during movement through the sliding fit structure of the guide groove 361 and the guide tongue 362, and effectively avoids the circumferential rotation of the arc-shaped slide plate 311 during movement, which would cause deviation of the guide wire body 1. Specifically, when the transmission cable 35 pulls the corresponding arc-shaped slide plate 311 to move axially along the guide wire body 1, the arc-shaped slide plate 311 slides in the guide groove 361 of the transition guide block 36 through the guide tongues 362 on both sides. In this way, the guide tongues 362 are blocked from rotating to the left and right by the side walls of the guide groove 361, which restricts the arc-shaped slide plate 311 to move in a straight line along the direction of the groove, and prevents it from rotating circumferentially around the guide wire body 1. This ensures that the orientation of the adjustment frame 32 is always accurate when it is pulled, and avoids adjustment deviation caused by the rotation of the arc-shaped slide plate 311.

[0059] In some preferred embodiments, an elastic damping layer is provided on the contact surface of the guide tongue 362 or the guide groove 361, forming a tight micro-interference fit between them. The elastic damping of the elastic damping layer increases progressively (not shown in the figure). Specifically, the thickness of the elastic damping layer gradually increases along the axial sliding direction of the guide groove 361. Through the above structural design, this solution further establishes a frictional resistance feedback mechanism that linearly increases with the increase of sliding displacement. In specific operation, as the arc-shaped sliding plate 311 is driven to move axially to open the adjusting frame 32, the guide tongue 362 slides deeper into the guide groove 361. Due to the gradual increase in the thickness of the elastic damping layer, the interference compression between the guide tongue 362 and the groove continuously increases. This gradually tightening fit causes the contact friction between the two to increase linearly, resulting in a tactile feedback of "the more you push, the heavier it gets." This not only eliminates mechanical play during the sliding process, but more importantly, it provides the operator with a tactile travel limit indication that does not rely on vision. The operator can intuitively perceive and adjust the opening degree of the mesh frame 32 through changes in hand resistance, effectively preventing excessive expansion of the mesh frame due to excessive force from the operator. This significantly improves the safety and controllability of the operation and further improves the use effect of the guide wire.

[0060] Based on the above embodiments, as a further preferred implementation method, in Figure 6 and Figure 7 As shown in the diagram, a locking and releasing assembly corresponding to the adjusting knob 341 is also provided inside the adjusting seat 34. The locking and releasing assembly includes a ratchet disc 371 coaxially disposed outside the lever 342, a pawl 372 located on one side of the ratchet disc 371 and abutting against it, and a rotating rod 373 rotatably extending through the upper part of the pawl 372 to the outside of the adjusting seat 34. A return torsion spring 374 is sleeved at the position where the rotating rod 373 passes through the outside of the rod body of the adjusting seat 34. One end of the return torsion spring 374 abuts against the adjusting seat 34, and the other end is connected to the rotating rod 373.

[0061] Obviously, since the adjusting frame 32 and the support wire assembly are usually made of a highly elastic nickel-titanium alloy, when the operator rotates the adjusting knob 341 to wind the transmission cable 35 to support the adjusting frame 32, the elasticity of the frame material itself will generate a reverse pulling force attempting to restore its original shape. Without an effective locking mechanism, once the operator releases their hand, the winding rod 342 is very likely to reverse under the tension of the cable, causing the adjusted frame shape to instantly retract and collapse, failing to maintain the support state required by the operator.

[0062] Therefore, this solution incorporates a locking and releasing mechanism to automatically lock and manually release the rotating state of the lever 342 using the mechanical cooperation between the ratchet disc 371 and the pawl 372. In operation, when the operator rotates the adjusting knob 341 to tighten the cable, the ratchet disc 371 rotates synchronously with the lever 342. At this time, the pawl 372, under the action of the return torsion spring 374, remains against the surface of the ratchet disc 371 and slides along the inclined surface of the ratchet teeth, allowing the cable to be tightened step by step. When the operator stops rotating and releases the lever, if the lever 342 attempts to reverse due to the reverse tension of the transmission cable 35, the tip of the pawl 372 immediately abuts against the vertical surface of the ratchet teeth, directly locking the ratchet disc 371 and preventing it from rotating back. The adjusted mesh frame shape is kept stable without the operator needing to hold it continuously. When the operation is over and it needs to be withdrawn, the operator only needs to turn the lever 373 exposed outside the adjustment seat 34 to overcome the resistance of the torsion spring 374 and drive the pawl 372 to lift up and disengage from the ratchet disc 371. At this time, the winding rod 342 is no longer obstructed. Under the action of the elastic force of the adjustment mesh frame 32 itself, the transmission cable 35 will drive the winding rod 342 to rotate in the opposite direction and release it, so that the front end of the guidewire automatically returns to a straight state, so as to facilitate the smooth withdrawal from the blood vessel and thus improve its use effect.

[0063] As an optional implementation, a flexible protective tube is coaxially sleeved outside the guide wire body 1 and located between the adjusting mesh frame 32 and the adjusting seat 34, and the transmission cable 35 passes through the interior of the flexible protective tube.

[0064] Based on the above solution, by setting up the flexible protective tube to completely enclose the transmission cable 35 inside the tube, the smooth and continuous outer wall of the protective tube achieves physical isolation between the cable assembly and the inner wall of the blood vessel, avoiding damage to the blood vessel tissue caused by the thin transmission cable 35 during tensioning or reciprocating movement. At the same time, it also reduces the frictional resistance generated by the direct contact between the cable and the blood vessel wall, significantly improving the smoothness and safety of the guidewire when it is advanced inside the blood vessel.

[0065] Based on the above embodiments, as an optional implementation method, please refer to... Figure 1 and Figure 9 The emitting tip 2 is provided with a guide head at one end away from the guide wire body 1. The outer contour of the emitting tip 2 gradually narrows into an inward concave arc from the guide head to the guide wire body 1 and forms a spindle structure. A conductive connector 4 is also provided at the proximal end of the guide wire body 1. The conductive connector 4 is connected to the emitting tip 2 through a wire passing through the guide wire body 1.

[0066] Understandably, this solution, by setting a conductive connector 4 and a wire, enables the emitting tip 2 to connect to an external energy generating device to ablate and open hard occlusions within blood vessels. Based on this, the spindle structure constructed using the concave arc transition of the outer contour of the emitting tip 2 can, on the one hand, guide the concentrated release of current energy in the transition region where the geometric cross-section changes, thereby improving the ablation and fragmentation efficiency of hard calcified tissue; on the other hand, the streamlined sidewall of this spindle structure has a significant physical expansion function. After the emitting tip 2 opens a tiny channel through energy ablation, its gradually changing outer diameter can smoothly push open the inner wall of the channel, significantly reducing the sidewall frictional resistance when the guidewire is advanced. Combined with the blunt design of the leading edge guide head, this allows the emitting tip 2 to smoothly and stably pass through the occluded lesion area while possessing highly efficient membrane-breaking penetration power, effectively preventing puncture of the normal blood vessel wall due to an excessively sharp tip or excessive pushing resistance.

[0067] Based on the above embodiments, as a further preferred implementation method, such as... Figure 9 As shown, a spirally wound cooling pipe 21 is provided on the outside of the firing tip 2. The two ends of the cooling pipe 21 are respectively connected to the cooling circulation pipe inside the guide wire body 1. A coolant injection seat 5 is also provided on the outside of the guide wire body 1 near the conductive connector 4. The coolant injection seat 5 has an injection port and an outlet on both sides that are connected to the cooling circulation pipe.

[0068] When the firing tip 2 performs high-frequency energy ablation to break up hard occlusions, significant heat accumulation is usually generated in the tip area. If heat cannot be dissipated in time, excessively high local temperatures may cause thermal damage to surrounding normal blood vessel tissue, or cause protein coagulation and thrombus adhesion at the blood contact surface, affecting the safety of guidewire use and energy emission efficiency.

[0069] Therefore, this solution achieves coolant circulation and heat dissipation through the aforementioned cooling pipe 21. During operation, externally supplied low-temperature coolant (such as saline solution) enters through the injection port, is transported along the internal channels of the guidewire to the front end, and flows through the spiral-shaped cooling pipe 21 wound around the surface of the firing tip 2. This spiral channel layout effectively extends the flow path of the coolant at the firing tip 2, allowing the flowing liquid to fully absorb and remove the heat generated during operation. The heat-carrying liquid is then discharged through the outlet. This continuous fluid circulation maintains the surface temperature of the firing tip 2 within a safe range, ensuring effective energy removal of lesions while preventing burns to the blood vessel walls, thus ensuring the safety of the guidewire during use.

[0070] In a further preferred embodiment, the spiral cooling tube 21 is not directly wound around the outside of the firing tip 2, but a spiral groove is formed on the outside of the firing tip 2, and the cooling tube 21 is embedded in the spiral groove. In this way, the recessed structure of the spiral groove is used to embed and install the cooling tube 21, which not only keeps the surface of the cooling tube 21 flush with the outer contour of the firing tip 2, avoiding the tube from protruding and increasing the resistance to passage or shifting during friction, but also significantly increases the contact area between the coolant and the heat-generating part, thereby further improving its cooling efficiency.

[0071] Based on the above embodiments, as a further preferred embodiment, the cooling pipe 21 has a D-shaped cross-section and has a planar fitting wall facing inward and an arc-shaped outer wall facing outward. A drainage groove is formed inside the planar fitting wall of the cooling pipe 21.

[0072] This solution, by designing the cooling pipe 21 with the aforementioned structure, further improves the assembly relationship and heat transfer efficiency between the cooling pipe 21 and the launch tip 2. Specifically, by utilizing the inward-facing planar contact wall of the cooling pipe 21, a large-area planar contact is formed between the cooling pipe 21 and the bottom of the spiral groove. Compared to the conventional circular pipe, which can only form a narrow line contact with the groove bottom, this planar contact wall directly expands the contact range for heat transfer from the metal substrate of the launch tip 2 to the wall of the cooling pipe 21, thereby enabling faster heat transfer from the launch tip 2 to the wall of the cooling pipe 21.

[0073] Simultaneously, by creating flow-guiding grooves inside the planar adhesive wall, when the coolant flows through these grooves, the abrupt change in the groove's cross-sectional shape causes flow disturbance, inducing local turbulence near the adhesive wall. This turbulent state effectively disrupts the laminar boundary layer (i.e., the thermal stagnant layer) adhering to the inner surface of the pipe wall, causing intense radial mixing and exchange between the heat-absorbing fluid at the pipe wall and the low-temperature fluid at the center of the pipe. This prevents the formation of a stable temperature-restricted layer on the pipe wall surface, significantly improving the convective heat transfer efficiency of the coolant to the pipe wall and ensuring efficient removal of heat accumulated at the launch tip 2.

[0074] Based on the above embodiments, as a preferred embodiment, the outer side of the transition guide block 36 is provided with a plurality of development mark points 381, the plurality of development mark points 381 are arranged sequentially at intervals along the axial direction of the transition guide block 36, and the arc-shaped slide plate 311 is provided with development indicator blocks 382 corresponding to the development mark points 381.

[0075] Understandably, since the axial movement distance of the arc-shaped sliding plate 311 directly determines the traction amplitude of the wire support assembly on the adjusting frame 32, there is a clear correspondence between the real-time position of the sliding plate and the degree of opening of the frame. Therefore, this solution utilizes the above structure to indicate the deformation state of the adjusting frame 32 by using the axial displacement position of the developing indicator block 382 relative to the plurality of developing mark points 381 when the arc-shaped sliding plate 311 slides along the axial direction of the transition guide block 36. This allows the operator to accurately know the current actual opening size and support state of the adjusting frame 32 located at the far end of the guide wire body 1 during implementation, thereby greatly improving the use effect of the guide wire.

[0076] Specifically, under X-ray fluoroscopic imaging, multiple imaging markers 381 fixed on the guidewire body 1 form a set of position reference scales, while the imaging indicator block 382, ​​which moves with the slide plate, acts as a scale reading. The operator can directly determine the current opening diameter or bending radius of the distal adjustment frame 32 by observing which imaging marker 381 the imaging indicator block 382 is currently aligned with. This visual position feedback mechanism allows the operator to intuitively and quantitatively control the actual shape of the frame without relying solely on the number of knob turns on the handle. This enables precise control of the frame's support force on the tube wall, preventing over- or under-expansion from affecting the device's stability, and significantly improving the accuracy and controllability of guidewire alignment during use.

[0077] The above are merely preferred embodiments of the present invention and do not limit the patent scope of the present invention. Any equivalent structural or procedural transformations made based on the content of the present invention's specification and drawings, or direct or indirect applications in other related technical fields, are similarly included within the patent protection scope of the present invention.

[0078] Furthermore, it should be specifically noted that the accompanying drawings are intended to schematically illustrate the basic structure and operating principle of the invention, and are not drawn to strict engineering scale. To clearly demonstrate the mating relationships of this solution, the dimensions, thicknesses, and gaps of related components in the drawings may be exaggerated or enlarged proportionally, and do not represent the actual physical dimensions of the product. Therefore, those skilled in the art, when implementing this invention, should combine the logic described in the text of the specification with the conventional tolerance requirements of existing mechanical manufacturing processes to conduct reasonable engineering design of the specific dimensions and mating relationships of each component, and should not be limited by the visual scale shown in the drawings.

[0079] Furthermore, the directional terms such as above, below, left, right, and center used in this specification are merely for clarity of description and are not intended to limit the scope of implementation of this invention. Any changes or adjustments to their relative relationships, without substantially altering the technical content, shall also be considered within the scope of implementation of this invention.

Claims

1. An adjustable intravascular shockwave guidewire, comprising a guidewire body, characterized in that, The distal end of the guidewire body has a firing tip, and an adjustment component is provided on the outside of the guidewire body and near the firing tip. The adjustment assembly includes a movable sleeve axially slidably sleeved outside the guidewire body and near the firing tip. An adjustment mesh frame is provided on the outside of the movable sleeve. The adjustment mesh frame has a hollow mesh structure, and its two ends are closed and fixed to the guidewire body. The movable sleeve is connected to the inner wall of the adjustment mesh frame through a wire support assembly. When the movable sleeve moves axially, the inner wall of the adjustment mesh frame is pulled by the wire support assembly, forcing the adjustment mesh frame to undergo radial outward arching deformation or axial bending deflection deformation under the constraint of fixed ends. The deformed adjustment mesh frame supports the blood vessel wall, thereby adjusting the position of the guidewire body on the blood vessel cross section. The movable sleeve includes multiple arc-shaped sliding plates that are sequentially spliced ​​together along the circumferential direction to form a tubular shape. Each arc-shaped sliding plate is independently slidably fitted onto the outer wall of the guide wire body. The wire support assembly includes a front support wire and a rear support wire respectively provided for each arc-shaped sliding plate. One end of the front support wire is connected to the outside of the arc-shaped slide plate near the launch tip, and the other end is connected to the inner wall of the adjustment frame near the launch tip. One end of the rear support wire is connected to the outside of the arc-shaped slide plate away from the launch tip, and the other end is connected to the inner wall of the adjustment frame away from the launch tip.

2. The adjustable intravascular shock waveguide wire according to claim 1, characterized in that: The adjustment assembly also includes an adjustment seat located outside the guidewire body and away from the firing tip. Inside the adjustment seat is a transmission cable corresponding to the arc-shaped sliding plate. The distal end of the transmission cable extends along the axial direction of the guidewire body and is connected to the arc-shaped sliding plate. Outside the adjustment seat is an adjustment knob corresponding to the transmission cable. At the bottom of the adjustment knob is a coil extending into the interior of the adjustment seat. The proximal end of the transmission cable inside the adjustment seat is wound around the outside of the coil.

3. The adjustable intravascular shock waveguide wire according to claim 1, characterized in that: Each of the adjacent arc-shaped sliding plates has a sliding member at its circumferential splicing sidewall. The sliding member includes a plurality of transition guide blocks that extend axially and are fixedly protruding on the outer wall of the guide wire body. Each transition guide block is located between two adjacent arc-shaped sliding plates. Each of the two side walls of the transition guide block has a guide groove that extends axially. Each arc-shaped sliding plate has a guide tongue that extends inward and is fitted into the guide groove at its circumferential side edge.

4. The adjustable intravascular shock waveguide wire according to claim 2, characterized in that: Inside the adjusting seat, there is also a locking release assembly corresponding to the adjusting knob. The locking release assembly includes a ratchet disc coaxially disposed outside the lever, a pawl located on one side of the ratchet disc and abutting against it, and a rotating rod rotatably extending through the upper part of the pawl to the outside of the adjusting seat. A return torsion spring is sleeved at the position where the rotating rod passes through the outside of the rod body of the adjusting seat. One end of the return torsion spring abuts against the adjusting seat, and the other end is connected to the rotating rod.

5. An adjustable intravascular shock waveguide wire according to claim 2, characterized in that: A flexible protective tube is coaxially sleeved outside the guide wire body and between the adjusting frame and the adjusting seat, and the transmission cable passes through the inside of the flexible protective tube.

6. The adjustable intravascular shock waveguide wire according to claim 1, characterized in that: The end of the emitting tip away from the guide wire body is provided with a guide head. The outer contour of the emitting tip gradually narrows into an inward concave arc from the guide head to the guide wire body and forms a spindle structure. A conductive connector is also provided at the proximal end of the guide wire body. The conductive connector is connected to the emitting tip through a wire passing through the guide wire body.

7. An adjustable intravascular shock waveguide wire according to claim 6, characterized in that: A spirally wound cooling tube is provided on the outside of the firing tip. The two ends of the cooling tube are respectively connected to the cooling circulation pipe inside the guide wire body. A coolant injection seat is also provided on the outside of the guide wire body near the conductive connector. The coolant injection seat has an injection port and an outlet on both sides that are connected to the cooling circulation pipe.

8. An adjustable intravascular shock waveguide wire according to claim 7, characterized in that: The cooling pipe has a D-shaped cross-section and has a flat, inner-facing wall and an arc-shaped outer wall. A drainage groove is provided inside the flat, inner-facing wall of the cooling pipe.

9. An adjustable intravascular shock waveguide wire according to claim 3, characterized in that: The transition guide block has multiple development marking points on its exterior. These multiple development marking points are arranged sequentially at intervals along the axial direction of the transition guide block. The arc-shaped slide plate has development indicator blocks corresponding to the development marking points.

Images