Laser ablation conduit system and implementation method with output of 355nm wavelength

Abstract

The present invention discloses a laser ablation catheter system and implementation method that outputs a 355nm wavelength band. The system includes a laser and a catheter; the laser outputs 355nm laser light; the catheter includes an optical fiber bundle and a targeting control unit, wherein the optical fiber bundle is used to transmit the 355nm laser light from the proximal end of the catheter to the distal end of the catheter; the targeting control unit includes a control handle, multiple rotating wheels provided on the handle, and a traction wire fixture provided on each rotating wheel; the traction wire fixture is used to fix the proximal end of a traction wire; the distal end of each traction wire is anchored at the bend of the sheath; when the rotating wheel is rotated to move toward the proximal end, the traction wire fixed to the rotating wheel is tightened, causing the catheter to bend parallel to the axis of the blood vessel. By tightening the unilateral traction wire, the intravascular catheter can adjust its posture parallel to the axis of the blood vessel, avoiding damage to the normal blood vessel wall caused by laser irradiation of the blood vessel.

Description

Technical Field

[0001] This invention relates to the field of intravascular laser ablation technology, and in particular to a laser ablation catheter system and implementation method that outputs a 355nm wavelength. Background Technology

[0002] Endovascular intervention is currently the first-line treatment for atherosclerotic diseases, but it still has limitations when dealing with complex lesions such as long-segment chronic total occlusion (CTO), severe calcified lesions, and in-stent restenosis (ISR).

[0003] Taking coronary infarction restenosis (ISR) as an example, this disease is a common complication after percutaneous coronary intervention (PCI) and a persistent challenge since the advent of PCI treatment. While the incidence of ISR has further decreased with the advent of drug-eluting stents, it still reaches approximately 10%. Coupled with my country's large patient base for interventional procedures and a high recurrence rate, this creates a heavy disease burden. However, its pathological mechanisms are complex, the lesion components are diverse, intervention measures are limited, and clinical prognosis is poor, necessitating the development of new treatment technologies. Laser ablation technology can treat restenosis lesions by reducing and modifying plaque volume, while avoiding damage to normal tissue and stent structures, theoretically superior to existing balloon and rotational atherectomy techniques.

[0004] Currently, the mainstream laser ablation product in the domestic market is Philips' second-generation coronary excimer cold laser system. Its ablation functional unit, namely the catheter system, can output excimer laser wavelength (308nm), which can destroy tissue molecular bonds and efficiently ablate lipid plaques and fibrous plaques in blood vessels. However, due to its large pulse width and low peak power, it has no advantage in treating calcified lesions.

[0005] Joseph A. et al. investigated the mechanism of action of ultraviolet laser on calcified lesions through in vitro experiments, confirming that lasers in the 355nm band can effectively "vaporize" the collagen portion of calcified lesions. Simultaneously, the instantaneous "explosive" force generated by the "vaporization" of collagen components causes the phosphate portion of the calcified lesions to break down into tiny fragments, thereby achieving localized erosion of the calcified lesions.

[0006] Because the effective diameter range for laser ablation using 355nm light energy is small, and the distribution of calcified lesions within the blood vessel lumen is irregular, implementing 355nm laser ablation on existing catheter systems is not easy. The main problems are: existing catheters cannot be flexibly adjusted, requiring repeated adjustments to ensure the laser is precisely aimed at the lesion for cutting; existing catheter systems, such as the invention patent application number 202110309720.6 entitled "Laser Ablation Catheter," use a laser beam combiner to form an expanded laser beam; however, during ablation, it cannot guarantee that the laser output end is coaxial with the blood vessel. If the catheter deviates from the blood vessel axis, it can easily cause the laser to accidentally damage the blood vessel, resulting in vascular injury or even perforation.

[0007] Therefore, it is essential to provide a laser ablation conduit system and implementation method with an output wavelength of 355nm to improve the accuracy and safety of the laser ablation process. Summary of the Invention

[0008] Therefore, the purpose of this invention is to provide a laser ablation catheter system and implementation method that outputs a 355nm wavelength. By setting a target control unit, the distal end of the traction wire is anchored at the bend of the sheath. By pulling the traction wire, the posture of the intravascular catheter can be adjusted parallel to the axis of the blood vessel.

[0009] To achieve the above objectives, the present invention proposes a laser ablation conduit system that outputs a 355nm wavelength, comprising a laser and a conduit;

[0010] The laser outputs a 355nm laser beam;

[0011] The catheter includes an optical fiber bundle and a targeting control unit, the optical fiber bundle being used to transmit 355nm laser light from the proximal end of the catheter to the distal end of the catheter;

[0012] The targeting control unit includes a control handle, multiple rotating wheels mounted on the handle, and traction wire fixing components mounted on the rotating wheels. Each traction wire fixing component is used to fix the proximal end of a traction wire. The distal end of each traction wire is anchored at the bend of the sheath. When the rotating wheel is rotated, the traction wire fixing component slides axially, causing the traction wire to be tightened and the catheter to bend parallel to the blood vessel axis.

[0013] More preferably, the distal end of the spindle of the control handle is further provided with a position sensor, the distal end of which is connected to the proximal end of the traction wire, and the position sensor is used to measure the displacement length of the traction wire.

[0014] More preferably, the traction wire is made of nickel-titanium alloy or nylon material.

[0015] More preferably, the rotating wheel has four wheels arranged in a front-to-back pattern; the sheath has four fixed anchor points and multiple sliding anchor points at the bend; the fixed anchor points are arranged opposite each other in pairs; the sliding anchor points are used to guide the sliding of the traction wire in the catheter.

[0016] More preferably, the control handle is threadedly connected to the rotating wheel, and the axial distance between the traction wire fixing member and the control handle is changed when the rotating wheel rotates, thereby pulling the traction wire.

[0017] A further preferred embodiment includes a dual imaging ring, comprising a distal imaging ring and a proximal imaging ring; the distal and proximal imaging rings are fitted inside the distal end of the catheter at a preset interval, and are used to determine whether the application end of the catheter is coaxial with the blood vessel under X-ray during the laser ablation process.

[0018] More preferably, the distance between the distal developing ring and the proximal developing ring is 2-3 cm.

[0019] The present invention also provides a method for implementing a laser ablation conduit system with an output wavelength of 355nm, for implementing the above-mentioned laser ablation conduit system with an output wavelength of 355nm, comprising the following steps:

[0020] S1. Under the large C-contrast imaging environment, locate the center of the distal and proximal contrast rings;

[0021] S2. Calculate the curvature of the catheter position corresponding to the center line segment of the distal and proximal contrast rings.

[0022] S3. Convert the curvature into the angle to be adjusted of the conduit;

[0023] S4. Calculate the length of the traction wire that will be tightened or loosened based on the angle to be adjusted of the catheter.

[0024] Further preferably, the method includes calculating the three-dimensional curvature of the corresponding catheter position based on the center line connecting the distal and proximal imaging rings, forming a three-dimensional curvature array (λx, λy, λz); determining whether the curvature in each direction of the three-dimensional curvature array exceeds a preset threshold, and preferentially adjusting the length of the traction line in the direction that exceeds the preset threshold.

[0025] The laser ablation conduit system and implementation method disclosed in this application, which outputs a 355nm wavelength, have at least the following advantages compared to the prior art:

[0026] 1. By setting up a targeting control unit, the distal end of the traction wire is anchored at the bend of the sheath. The scaling of the traction wires on both sides allows the intravascular catheter to be adjusted parallel to the vessel axis. This prevents the catheter from deviating from the vessel axis when the laser is emitted, thus avoiding accidental laser damage to the vessel.

[0027] 2. By setting up a double contrast ring, the catheter tip can be marked in a large C environment, making it easy for medical staff to identify. At the same time, the catheter adjustment angle can be calculated by the central axis of the double contrast ring, so as to achieve precise control of the catheter. Attached Figure Description

[0028] Figure 1 This is a schematic diagram of the laser ablation conduit system with an output wavelength of 355nm according to the present invention.

[0029] Figure 2 A cross-sectional view of the control handle provided by the present invention.

[0030] Figure 3 This is a schematic diagram showing the installation position of the traction wire provided by the present invention.

[0031] Figure 4 for Figure 3 A cross-sectional view of the AA section of the traction wire.

[0032] Figure 5 This is a flowchart illustrating the implementation method of the laser ablation conduit system outputting 355nm wavelength in this invention.

[0033] In the picture:

[0034] 00. Connector; 01. Control handle; 02. Conduit; 03. Application end; 011. Rotary wheel; 012. Traction wire fixing component; 013. Position sensor; 44. Sheath bend; 021. Fixed anchor point; 45. Sliding anchor point. Detailed Implementation

[0035] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0036] like Figure 1 As shown, the laser ablation conduit system with an output of 355nm wavelength provided in Embodiment 1 of the present invention includes a laser, a conduit 02, a host and a display, wherein the laser is disposed inside the host and is used to output 355nm laser.

[0037] The catheter includes a fiber bundle and a targeting control unit. The fiber bundle is used to transmit a 355nm laser from the proximal end of the catheter to the distal end.

[0038] like Figure 2 As shown, Example 2:

[0039] The targeting control unit includes a control handle 01, multiple rollers 011 mounted on the handle, and traction wire fixing members 012 mounted on the rollers 011. Each traction wire fixing member is fixedly connected to the proximal end of a traction wire. The distal end of each traction wire is anchored at the bend of the sheath. When the rollers are rotated, the traction wire fixing members slide axially, causing the traction wire to be tightened, thereby causing the catheter to bend parallel to the blood vessel axis.

[0040] like Figure 3 As shown, Example 3:

[0041] The distal end of each traction wire is anchored at the bend in the sheath 44. When the wheel is in the initial position, the traction wire is released, and the distal end of the catheter is not bent. When the wheel is rotated clockwise, the traction wire fixing element slides axially towards the proximal end, tightening the corresponding traction wire and causing the catheter to bend parallel to the vessel axis. Rotating the wheel counterclockwise resets the distal end of the catheter to its original bend direction; conversely, rotating the wheel counterclockwise achieves bend on the corresponding side, and rotating the wheel clockwise resets the distal end of the catheter. Further, two wheels are provided, arranged front to back, and two fixed anchor points and two corresponding sliding anchor points are provided at the bend in the sheath. Preferably, four wheels are provided, arranged front to back; four fixed anchor points and multiple sliding anchor points are provided at the bend in the sheath 44; the four fixed anchor points 021 can be circumferentially arranged on the same catheter cross-section, such as... Figure 4 As shown, they can also be grouped in pairs, with the two anchor points in each group set opposite each other, and the two groups of anchor points spaced a distance apart. The four fixed anchor points correspond to the four bending directions of the conduit.

[0042] It should be noted that the sheath is placed at the distal end of the catheter. During the intervention, a guidewire is used to pass through the sheath to guide the catheter structure at the rear end into the patient's body.

[0043] Further at the proximal end of the sheath bend 44 (e.g.) Figure 3 A sliding anchor point 45 is provided on the left side of the sheath bend 44 to guide the sliding of the traction wire within the catheter. When the catheter approaches the lower vessel wall, pulling the traction wire a causes the catheter to bend upward along the vessel axis, deviating from the lower vessel wall. Similarly, when the catheter approaches the upper vessel wall, pulling the traction wire b causes the catheter to bend downward along the vessel axis, deviating from the upper vessel wall. Preferably, when four fixed anchor points are provided at the sheath bend 44, bending can be achieved in four directions relative to the catheter cross-section: up, down, left, and right.

[0044] In this embodiment, under the large C-band coronary angiography environment, the main unit of the laser ablation catheter system is connected to the catheter via connector 00. The connection is sequentially arranged according to the connection structure described in embodiments 1-3 above. After the laser ablation catheter is pushed to the lesion location, the laser emitted by the laser reaches the lesion site through connector 00 and the optical fiber in the catheter to perform plaque ablation. The physician can view the position of the ablation catheter on the monitor in the coronary angiography environment at any time. When it is necessary to adjust the distal end of the catheter, the corresponding wheel is rotated according to the relative position relationship between the target position and the distal end of the catheter. The corresponding traction wire is tightened, causing the catheter to bend parallel to the blood vessel axis.

[0045] Furthermore, a position sensor 013 is provided at the far end of the spindle of the control handle 01. The far end of the position sensor 013 is connected to the near end of the traction wire, and the position sensor 013 is used to measure the displacement length of the traction wire.

[0046] Furthermore, the traction wire is made of nickel-titanium alloy or nylon. The control handle 01 is threadedly connected to the traction wire fixing member 012. When the rotating wheel 011 rotates, the axial distance between the traction wire fixing member 012 and the control handle 01 is changed, thereby pulling the traction wire.

[0047] To more clearly display the catheter's orientation under large-area contrast imaging, this embodiment also includes dual contrast rings, comprising a distal contrast ring and a proximal contrast ring. The distal and proximal contrast rings are fitted inside the distal end of the catheter at a preset interval. By observing the relative position of the line connecting the centers of the two contrast rings to the blood vessel, it is possible to determine, under X-rays, during laser ablation whether the catheter's application end (O3) is coaxial with the blood vessel. The distance between the distal and proximal contrast rings ranges from 2-3 cm.

[0048] The laser ablation conduit system with an output wavelength of 355nm provided by this invention is used in the following manner, including the following steps:

[0049] S1. Under the large C-contrast imaging environment, locate the center of the distal and proximal contrast rings;

[0050] S2. Calculate the curvature of the catheter position corresponding to the center line segment of the distal and proximal contrast rings.

[0051] S3. Convert the curvature into the angle to be adjusted of the conduit;

[0052] S4. Calculate the length of the traction wire that will be tightened or loosened based on the angle to be adjusted of the catheter.

[0053] It also includes calculating the three-dimensional curvature of the corresponding catheter position based on the center line connecting the distal and proximal imaging rings, forming a three-dimensional curvature array (λx, λy, λz); determining whether the curvature in each direction of the three-dimensional curvature array exceeds a preset threshold, and prioritizing the adjustment of the traction line length in the direction that exceeds the preset threshold.

[0054] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A laser ablation conduit system with an output wavelength of 355nm, characterized in that, The device includes a laser, a catheter, and dual contrast rings. The laser outputs a 355nm laser beam. The catheter includes an optical fiber bundle and a targeting control unit. The optical fiber bundle transmits the 355nm laser beam from the proximal end of the catheter to the distal end. The dual contrast rings include a distal contrast ring and a proximal contrast ring. The distal and proximal contrast rings are fitted inside the distal end of the catheter at a preset interval. They are used to determine whether the catheter's application end is coaxial with the blood vessel under X-ray during laser ablation. The curvature of the catheter position corresponding to the center line segment connecting the distal and proximal contrast rings is calculated. The curvature is converted into the catheter's angle to be adjusted. The length of the traction wire to be tightened or relaxed is calculated based on the catheter's angle to be adjusted. The targeting control unit includes a control handle, multiple rotating wheels mounted on the handle, and traction wire fixing components mounted on the rotating wheels. Each traction wire fixing component is used to fix the proximal end of a traction wire. The distal end of each traction wire is anchored at the bend of the sheath and crosses symmetrically at the bend of the sheath. When the rotating wheel is rotated, the traction wire fixing component slides axially, causing the traction wire to be tightened and the catheter to bend parallel to the blood vessel axis.

2. The laser ablation conduit system with an output wavelength of 355nm as described in claim 1, characterized in that: The control handle's main shaft is also equipped with a position sensor at its distal end. The distal end of the position sensor is connected to the proximal end of the traction wire, and the position sensor is used to measure the displacement length of the traction wire.

3. The laser ablation conduit system with an output wavelength of 355nm as described in claim 1, characterized in that: The traction wire is made of nickel-titanium alloy or nylon.

4. The laser ablation conduit system with an output wavelength of 355nm as described in claim 1, characterized in that: The rotating wheel has four wheels arranged in a front-to-back pattern; the sheath has four fixed anchor points and multiple sliding anchor points at its bend; the fixed anchor points are arranged in pairs opposite each other; the sliding anchor points are used to guide the sliding of the traction wire within the catheter.

5. The laser ablation conduit system with an output wavelength of 355nm as described in claim 1, characterized in that: The control handle is threadedly connected to the rotating wheel. The rotation of the rotating wheel changes the axial distance between the traction wire fixing component and the control handle, thereby pulling the traction wire.

6. The laser ablation conduit system with an output wavelength of 355nm as described in claim 1, characterized in that: The distance between the distal and proximal developing rings is 2-3 cm.

7. A method for implementing a laser ablation conduit system with an output wavelength of 355nm, characterized in that: A laser ablation conduit system for implementing any one of claims 1-6, comprising the following steps: S1. Under the large C-contrast imaging environment, locate the center of the distal and proximal contrast rings; S2. Calculate the curvature of the catheter position corresponding to the center line segment of the distal and proximal contrast rings. S3. Convert the curvature into the angle to be adjusted of the conduit; S4. Calculate the length of the traction wire that will be tightened or loosened based on the angle to be adjusted of the catheter.

8. The method for implementing the laser ablation conduit system with an output wavelength of 355nm according to claim 7, characterized in that: It also includes calculating the three-dimensional curvature of the corresponding catheter position based on the center line connecting the distal and proximal imaging rings, forming a three-dimensional curvature array (λx, λy, λz); determining whether the curvature in each direction of the three-dimensional curvature array exceeds a preset threshold, and prioritizing the adjustment of the traction wire length in the direction that exceeds the preset threshold.

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