Multi-target lithotripsy device and therapeutic instrument

Abstract

The application discloses a multi-target point lithotripsy device and therapeutic instrument, which comprises a multi-fiber catheter, a balloon, a laser and a target point adjusting device, wherein: the balloon cavity is used for loading inflation medium to form a liquid environment for shock wave generation; the laser is used for emitting a pulsed laser beam outward; the multi-fiber catheter comprises a catheter and a plurality of shock wave generating fibers arranged in the inner cavity of the catheter; the target point adjusting device comprises a mirror and a driving unit, the mirror is used for receiving and reflecting the pulsed laser beam, so that the pulsed laser beam can be coupled to at least one of the plurality of shock wave generating fibers; and the driving unit is used for driving the mirror to deflect around a first rotation axis and / or a second rotation axis. The multi-target point lithotripsy device can quickly and accurately realize the incidence of focused light beams on different positions of the optical fiber, so that multi-target point lithotripsy can be realized with smaller size and higher sensitivity.

Description

Technical Field

[0001] This application relates to the field of interventional medical device technology, and in particular to a multi-target lithotripsy device and treatment instrument. Background Technology

[0002] Vascular calcification can lead to narrowing or even complete occlusion of blood vessels, and is highly associated with major clinical diseases such as myocardial infarction and stroke. Traditional treatments for vessels with calcification include interventional high-pressure balloons and cutting / spinous process balloons. For individual vessels completely blocked by calcifications, rotational atherectomy can be used to remove the calcified lesions. However, among these methods, interventional high-pressure balloons are prone to causing vascular tears or perforations, and even dissections; cutting / spinous process balloons have limited effectiveness for annular calcifications; rotational atherectomy is extremely demanding on the surgeon's experience, and improper control of the depth and position can easily cause endothelial damage. Furthermore, rotational atherectomy is difficult to perform in areas with tortuous vessel morphology. Given these limitations, multi-target lithotripsy has gradually become one of the mainstream clinical approaches for managing complex intravascular calcification.

[0003] Multi-target lithotripsy typically refers to the use of multiple fiber optic catheters to emit laser beams for lithotripsy from different fibers in a predetermined sequence, thereby fragmenting stones at different points within the blood vessel. Currently, there are many laser emission assemblies on the market compatible with multi-fiber catheters, such as those disclosed in CN119403508A. (Refer to the appendix of this patent.) Figure 2 As shown in Figure B, in order to ensure that the source beam 224A is injected into the guides 222A-222E (optical fibers) in a preset order / timing sequence, a redirector 266 is mounted on a multiplexer stage 262 capable of one-dimensional translation. The translation of the multiplexer stage 262 alters the injection of the guide beam (laser beam) 224B into any of the guides 222A-222E. In another embodiment described in this patent (the structural principle is illustrated in the appendix to the patent specification),... Figure 3 B), by rotating the component 328 and the multiple lenses inside it, it is also possible to change the direction of the guide beam (laser beam) 224B into different guides.

[0004] While the method described in this patent can change the position of the laser beam, fixing the component to a movable electric displacement stage and controlling its translation via a motor has several drawbacks: Firstly, the control precision of the electric displacement component is not high enough; secondly, for precision optical paths, non-fixed components can introduce systematic errors and mechanical wear during repeated use; furthermore, this translational alignment system design requires reserved space for both the electric displacement component and the fiber coupler, and the required space increases rapidly with the number of fibers. Using a multi-lens combination to change the laser beam's incident position requires multiple lens sets to achieve the rotation of the optical axis. Multiple lens sets introduce problems such as loss, astigmatism, aberrations, and assembly complexity. Summary of the Invention

[0005] This application provides a multi-target lithotripsy device and treatment instrument. The multi-target lithotripsy device can quickly and accurately focus a beam to excite optical fibers at different positions, thereby achieving multi-target lithotripsy with a smaller size and greater sensitivity.

[0006] According to a first aspect of this application, a multi-target lithotripsy device is provided, comprising a multi-fiber conduit, a balloon connected to the distal end of the multi-fiber conduit, a laser, and a target setting device, wherein: the cavity of the balloon is used to load an expansion medium to form a liquid environment for shock wave generation; the laser is used to emit a pulsed laser beam outward; the multi-fiber conduit includes a conduit element and multiple shock wave generating optical fibers embedded in the cavity of the conduit element along a direction parallel to the extension of the conduit element; the target setting device includes a reflector and a driving unit, the reflector being used to receive and reflect the pulsed laser beam so that the pulsed laser beam can be coupled to at least one of the multiple shock wave generating optical fibers; the driving unit is used to drive the reflector to deflect about a first axis and / or a second axis, wherein: the first axis and the second axis are orthogonally arranged on a plane parallel to the mirror surface of the reflector.

[0007] In some embodiments, the target setting device further includes an angle sensor for detecting the angle of rotation of the reflector around the first axis or the second axis.

[0008] In some embodiments, the rotation angle detected by the angle sensor can be fed back to the drive unit so that the drive unit can form a closed-loop control.

[0009] In some embodiments, multiple shock wave generating optical fibers are arranged in an array within the cavity of the conduit.

[0010] In some embodiments, the multi-target lithotripsy device further includes a focusing module disposed between the target setting device and the multi-fiber conduit, the focusing module including a lens wheel for changing the shape and size of the light spot, and a light homogenizing element for homogenizing the light spot.

[0011] According to a second aspect of this application, a therapeutic device is also provided, the therapeutic device comprising the above-described multi-target lithotripsy device and an optical signal demodulation and control system.

[0012] In some embodiments, the therapeutic device further includes a calibration component, which includes an optical fiber fixing sleeve and multiple calibration optical fibers equal in number to the shock wave generating optical fibers. The multiple calibration optical fibers are arranged in the optical fiber fixing sleeve in the same manner as the shock wave generating optical fibers within the conduit. A reflective film capable of reflecting the pulsed laser beam is provided on one end face of the multiple calibration optical fibers. The calibration component is used to replace the multi-fiber conduit and is coupled to the target adjustment device.

[0013] In some embodiments, the fiber fixing sleeve is further filled with a filler for fixing the calibration fiber, and the fiber fixing sleeve is provided with a light-absorbing layer for absorbing stray light on the end side where the reflective film is located.

[0014] In some embodiments, the optical fiber fixing sleeve is a metal sleeve, the filler is a solid formed by sintering glass-ceramic powder filled in the metal sleeve, and the reflective film is an alumina film layer.

[0015] In some embodiments, the therapeutic device further includes a beam splitter and a photodetector, wherein the beam splitter is configured such that the light beam reflected by the reflective film enters the photodetector.

[0016] The technical solutions provided by the embodiments of this application may include the following beneficial effects: The multi-target lithotripsy device and treatment instrument provided in this application achieve precise and rapid switching of the pulsed laser beam between multiple shock wave generating fibers by setting a reflector that can deflect around two orthogonal axes between the laser and the multi-fiber conduit. This solves the technical problems of insufficient control precision, severe mechanical wear, large space occupation of the existing translational scheme, and optical loss, aberration and complicated assembly and adjustment of the multi-lens rotational scheme.

[0017] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and do not limit this application. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the optical path system under normal operating conditions of a therapeutic device according to an embodiment of this application; Figure 2 This is a schematic diagram of the optical path system of a therapeutic device under calibration conditions according to an embodiment of this application; Figure 3 This is a schematic diagram illustrating the principle of how the target setting device changes the position of the light spot; Figure 4 This is a cross-sectional schematic diagram of a multi-fiber duct according to an embodiment of this application; Figure 5 This is a schematic diagram of the structure of a calibration component according to an embodiment of this application.

[0019] Explanation of reference numerals in the attached figures 100. Multi-fiber conduit; 11. Conduit fittings; 12. Shock wave generating fiber optic cable; 200. Target setting device; 300. Laser; 400. Beam splitter; 500, Focusing Module; 600. Photodetector; 700. Calibration component; 71. Fiber optic fixing sleeve; 72. Calibration fiber; 73. Filler. Detailed Implementation

[0020] Exemplary embodiments will now be described in detail, examples of which are illustrated in the accompanying drawings. When the following description relates to the drawings, unless otherwise indicated, the same numbers in different drawings denote the same or similar elements. The modes described in the following exemplary embodiments do not represent all modes consistent with this application. Rather, they are merely examples of apparatuses and methods consistent with some aspects of this application as detailed in the appended claims.

[0021] It should be understood that the terms "first," "second," and similar terms used in this application specification and claims do not indicate any order, quantity, or importance, but are merely used to distinguish different components. Similarly, the terms "a" or "one," and similar terms do not indicate a quantity limitation, but rather indicate the presence of at least one. Unless otherwise stated, the terms "front," "rear," "lower," and / or "upper," and similar terms are for illustrative purposes only and are not limited to a location or spatial orientation. The terms "comprising" or "including," and similar terms, mean that the elements or objects preceding "comprising" or "including" encompass the elements or objects listed following "comprising" or "including" and their equivalents, and do not exclude other elements or objects. The terms "connected," "linked," and similar terms are not limited to physical or mechanical connections, and can include electrical connections, whether direct or indirect.

[0022] The embodiments of this application will now be described in detail with reference to the accompanying drawings. Unless otherwise specified, the features in the following embodiments can be combined with each other.

[0023] like Figure 1 As shown, this embodiment first provides a multi-target lithotripsy device, including a multi-fiber optic conduit 100, a balloon connected to the distal end of the multi-fiber optic conduit 100, a laser 300, and a target setting device 200. The balloon cavity is used to load an expansion medium to create a liquid environment for shock wave generation.

[0024] refer to Figure 4 As shown, the multi-fiber catheter 100 includes a catheter element 11 and multiple shock wave generating fibers 12 embedded in its lumen along a direction parallel to the extension of the catheter element 11. Depending on the location of the lithotripsy target, the distal end of the shock wave generating fiber 12 in the multi-fiber catheter 100 can extend into the balloon to directly generate a ring-shaped shock wave in the liquid environment to target the ring-shaped calcifications in the blood vessel; or the shock wave can be transmitted forward through a suitable shock wave conductor to form a forward shock wave to target the occlusive calcifications in the blood vessel.

[0025] Laser 300 is used to emit a pulsed laser beam, the wavelength and other parameters of which are set according to the needs of shock wave generation. The pulsed laser beam emitted by laser 300 can be directly or coupled to the shock wave generating fiber 12 in the multi-fiber duct 100 through an optical coupling device.

[0026] Return to reference Figure 1 and Figure 3 As shown, the target setting device 200 includes a reflector and a driving unit. The reflector receives and reflects the pulsed laser beam emitted by the laser 300, and the driving unit drives the reflector to deflect around a first axis and / or a second axis, wherein the first and second axes are orthogonally arranged on a plane parallel to the mirror surface of the reflector.

[0027] like Figure 1 As shown, the reflector in the target setting device 200 deflects a small angle around the first axis from the position indicated by the solid line in the figure, resulting in a significant change in the direction of the pulsed laser beam directed towards the multi-fiber catheter 100. Depending on the needs of the interventional procedure, it may be necessary to generate shock waves at different circumferential locations within the blood vessel to treat calcifications at corresponding locations. In the scheme of this application, by driving the reflector to deflect a small angle through the driving unit, the pulsed laser beam can be switched to the shock wave generating fiber 12 at different locations, thereby meeting the need to generate shock waves at different locations.

[0028] refer to Figure 3 As shown in the figure, the reflector in the target setting device 200 is deflected by an angle θ from the solid line to the dashed line. The distance Δx that the pulsed laser beam spot position at plane A shifts can be calculated according to the following formula: △X≈2*L*θ Where: L is the distance between the center point of the reflector and the center point of the focusing module 500.

[0029] As can be seen from the above formula, there is a coefficient 2L between the distance Δx shifted by the laser spot position and the deflection angle θ of the reflector, meaning that a very small deflection angle θ of the reflector can cause a significant change in Δx. Therefore, when it is necessary to change the location of the shock wave generated by the pulsed laser beam incident on the shock wave generating fiber 12 (i.e., to change the laser spot position), it is only necessary to control the reflector to rotate around the first and / or second axes by a very small deflection angle via the drive unit, thus changing the position of the shock wave generated by the shock wave generating fiber 12.

[0030] The sensitive adjustment method in this application has a faster response compared to the method of changing the position of the light spot by translation. Since the reflector does not need to be deflected at a large angle to meet the usage requirements, the space occupied by the optical path is roughly the same as that occupied by using a non-rotatable reflector. At the same time, since the reflector rotates around a fixed first or second axis under the drive of the drive unit, it is equivalent to each component in the optical path having a definite installation position. In contrast, in the method of changing the position of the light spot by translation, since the reflector needs to be translated, there are loose components in the optical path without a definite installation position, which leads to systematic errors and mechanical wear during repeated use. Therefore, the target adjustment device 200 in this application has better reusability and the reuse accuracy is easy to guarantee.

[0031] In some embodiments, the target setting device 200 may further include an angle sensor for detecting the rotation angle of the reflector around the first or second rotation axis and feeding the angle back to the drive unit. Thus, the drive unit can use the angle signal fed back by the angle sensor as input to achieve closed-loop control of the reflector's rotation angle, thereby more precisely controlling the coupling of the pulsed laser beam into the preset shock wave generating fiber 12 to generate a shock wave at the target location as needed.

[0032] like Figure 4 As shown, multiple shock wave generating optical fibers 12 are arranged in an array within the inner cavity of the conduit 11. This array arrangement of shock wave generating optical fibers 12 better meets the requirements for generating shock waves from multiple targets. Furthermore, compared to the aforementioned method of changing the beam position through translation, the space occupied by the target adjustment device 200 does not significantly increase with the increase in the number of shock wave generating optical fibers 12. Therefore, given the allowable radial dimensions, a greater number of shock wave generating optical fibers 12 can be incorporated.

[0033] like Figure 1As shown, the multi-target lithotripsy device also includes a focusing module 500 disposed between the target setting device 200 and the multi-fiber conduit 100. This focusing module 500 includes a lens wheel for changing the shape and size of the light spot, and a homogenizing element for homogenizing the light spot. The lens wheel is equipped with multiple focal lenses of various sizes. When the surgeon needs to excite multiple shock wave generating fibers 12, they can easily obtain a light spot of appropriate size by rotating the lens wheel and changing the focal lenses. This allows for more efficient energy coupling in a scheme where the shock wave generating fibers 12 are arranged in an array.

[0034] This application also provides a therapeutic device, which includes the multi-target lithotripsy device of any of the above embodiments, and an optical signal demodulation and control system.

[0035] In some embodiments, the therapeutic device may further include a calibration element 700. This calibration element 700 is used to replace the multi-fiber conduit 100 and is coupled to the target setting device 200. The calibration element 700 includes a fiber optic retainer 71 and a plurality of calibration fibers 72, equal in number to the shock wave generating fibers 12. The plurality of calibration fibers 72 are arranged within the fiber optic retainer 71 in the same manner as the shock wave generating fibers 12 within the conduit 11. A reflective film capable of reflecting the pulsed laser beam is provided on one end face of each of the plurality of calibration fibers 72.

[0036] Generally speaking, the shock wave generating fiber 12 that has the highest overlap with the spot of the pulsed laser beam and the smallest directional angle can emit the strongest pulsed laser beam, thereby generating the strongest shock wave at the corresponding target location.

[0037] When the calibration component 700 replaces the multi-fiber conduit 100 and is coupled to the target setting device 200, it corresponds to an equipment calibration scenario. In this scenario, the calibration component 700 is equivalent to a simulator of the multi-fiber conduit 100: it calibrates which of the calibrated fibers 72 reflects the strongest light intensity into the external PD through the reflective film, and the corresponding shock wave generating fiber 12 is the fiber that can generate the strongest shock wave under operating conditions. Understandably, after repeated use, the angle and spot of the pulsed laser beam may change slightly. Verification and confirmation through the calibration component 700 can effectively improve the effect of shock wave operation.

[0038] Meanwhile, the treatment device will have a certain degree of error after leaving the factory. Through the linkage between the calibration component 700 and the power detection component, the power change of the pulsed laser beam can be detected in time, and power compensation can be performed as needed to ensure the intensity of the shock wave.

[0039] like Figure 2As shown, in order to receive the reflected light from the calibration element 700, the therapeutic device may further include a beam splitter 400 and a photodetector 600. The pulsed laser beam emitted by the laser 300 reflects off the reflective film of the calibration element 700. Figure 2 The light beam is reflected at the lower end face of the calibration component 700. After passing through the target setting device 200, the reflected beam is reflected upwards on the beam splitter surface of the beam splitter 400 and enters the photodetector 600. Under calibration conditions, the angle, spot, and other characteristics of the pulsed laser beam can be confirmed by analyzing the beam received by the photodetector 600.

[0040] like Figure 5 As shown, the fiber optic fixing sleeve 71 is also filled with a filler 73 for fixing the calibration fiber 72. The filler 73 ensures that the calibration fiber 72 within the fiber optic fixing sleeve 71 remains in a relatively fixed position without accidental displacement. A light-absorbing layer is provided on the end side of the fiber optic fixing sleeve 71 where the reflective film is located. This light-absorbing layer absorbs incoming stray light, thereby preventing heat accumulation caused by stray light within the calibration component 700.

[0041] In some embodiments, the fiber optic fixing sleeve 71 can be a metal sleeve. The filler 73 can be a solid formed by sintering glass-ceramic powder filled inside the metal sleeve. The reflective film is an alumina film layer.

[0042] When manufacturing calibration component 700, calibration optical fibers 72 can be arranged in a preset manner, filled with glass-ceramic powder or other similar materials, sintered and cooled together, and then cut and ground as a whole to form a core. Afterwards, an aluminum oxide reflective film layer is deposited on one end face of the calibration optical fiber 72. After the coating operation, refer to... Figure 5 As shown in the diagram, the coated core is installed into the metal sleeve from left to right. A black coating is sprayed onto the right end face of the metal sleeve to form a light-absorbing layer, thus creating... Figure 5 The overall structure is shown in the diagram. Thus, the pulsed laser beam travels along... Figure 5 When the laser beam is incident on the calibration element 700 in the direction indicated by the middle arrow, the reflective film on the right side of the calibration fiber 72 reflects the pulsed laser beam and, according to... Figure 2 The light ultimately enters the photodetector 600 as shown in the diagram, while stray light accompanying the pulsed laser beam is absorbed by the light-absorbing layer on the right end face of the metal sleeve, thus preventing heat buildup.

[0043] The above are merely preferred embodiments of this application and are not intended to limit this application in any way. Although this application has disclosed preferred embodiments as above, it is not intended to limit this application. Any person skilled in the art can make some modifications or alterations to the above-disclosed technical content to create equivalent embodiments without departing from the scope of the technical solution of this application. Any simple modifications, equivalent changes and alterations made to the above embodiments based on the technical essence of this application without departing from the content of the technical solution of this application shall still fall within the scope of the technical solution of this application.

Claims

1. A therapeutic device, comprising a multi-target lithotripsy device and an optical signal demodulation and control system, characterized in that, The multi-target lithotripsy device includes a multi-fiber conduit (100), a balloon connected to the distal end of the multi-fiber conduit (100), a laser (300), and a target setting device (200), wherein: the cavity of the balloon is used to load an expansion medium to form a liquid environment for generating shock waves. The laser (300) is used to emit pulsed laser beams outward; The multi-fiber conduit (100) includes a conduit (11) and multiple shock wave generating optical fibers (12) embedded in the inner cavity of the conduit (11) along the extension direction parallel to the conduit (11). The target setting device (200) includes a reflector and a driving unit. The reflector is used to receive and reflect the pulsed laser beam so that the pulsed laser beam can be coupled to at least one of the multiple shock wave generating optical fibers. The driving unit is used to drive the reflector to deflect about a first axis and / or a second axis, wherein the first axis and the second axis are orthogonally arranged on a plane parallel to the mirror surface of the reflector. The therapeutic device also includes a calibration component (700), which includes an optical fiber fixing sleeve (71) and multiple calibration optical fibers (72) equal in number to the shock wave generating optical fiber (12). The multiple calibration optical fibers (72) are arranged in the optical fiber fixing sleeve (71) in the same manner as the shock wave generating optical fiber (12) within the conduit (11). A reflective film capable of reflecting the pulsed laser beam is provided on one end face of the multiple calibration optical fibers (72). The calibration component (700) is used to replace the multi-fiber conduit (100) and is coupled to the target adjustment device (200).

2. The therapeutic device according to claim 1, characterized in that, The target setting device (200) further includes an angle sensor for detecting the angle of rotation of the reflector around the first or second axis.

3. The therapeutic device according to claim 2, characterized in that, The rotation angle detected by the angle sensor can be fed back to the drive unit, enabling the drive unit to form a closed-loop control.

4. The therapeutic device according to claim 1, characterized in that, Multiple shock wave generating optical fibers (12) are arranged in an array within the cavity of the conduit (11).

5. The therapeutic device according to claim 4, characterized in that, The multi-target lithotripsy device also includes a focusing module (500) disposed between the target setting device (200) and the multi-fiber duct (100). The focusing module (500) includes a lens wheel for changing the shape and size of the light spot, and a light homogenizing component for homogenizing the light spot.

6. The therapeutic device according to claim 1, characterized in that, The fiber fixing sleeve (71) is also filled with a filler (73) for fixing the calibration fiber (72), and the fiber fixing sleeve (71) has a light-absorbing layer for absorbing stray light on the side where the reflective film is located.

7. The therapeutic device according to claim 6, characterized in that, The optical fiber fixing sleeve (71) is a metal sleeve, the filler (73) is a solid formed by sintering glass ceramic powder filled in the metal sleeve, and the reflective film is an aluminum oxide film layer.

8. The therapeutic device according to claim 1, characterized in that, The therapeutic device also includes a beam splitter (400) and a photodetector (600), wherein the beam splitter (400) is configured such that the light beam reflected by the reflective film enters the photodetector (600).

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