CN219021397U - Imaging shock wave lithotriptic sacculus catheter - Google Patents

Abstract

The application relates to the technical field of medical equipment, and relates to an imageable shock wave lithotripsy balloon catheter. Comprises a guiding device for guiding and positioning the working position; the sound wave transmitting device is arranged on the guiding device, the sound wave transmitting device is positioned on any side of the guiding device, the guiding device is provided with uniformly arranged transmitting ends, the transmitting ends are positioned in the sound wave transmitting device, and the sound wave transmitting device is guided to reach a designated position through the guiding device and is used for working treatment on a working position; and the feedback device is arranged in the sound wave transmitting device and is used for data feedback. The problems that after calcification lesions are treated by shock wave lithotripsy, the effect of vasodilation is difficult to quantitatively and accurately evaluate, and the optimal length and the optimal size of an implanted stent required by the dilated blood vessel are difficult to instantly confirm are solved.

Description

Imaging shock wave lithotriptic sacculus catheter

Technical Field

The application relates to the technical field of medical equipment, in particular to an imageable shock wave lithotripsy balloon catheter.

Background

Plaque in arteries will gradually calcifie as heart disease patients age and disease progresses. Such bone-like structural analogs can cause coronary stenosis, reduce coronary blood flow, and ultimately may result in total occlusion of the coronary artery. Chest pain can occur to patients due to the reduction of coronary blood flow, and a doctor is required to perform PCI to open blood vessels and recover the coronary blood flow. However, in 100 tens of thousands of us patients undergoing stent surgery each year, as many as 30% of the patients have calcified lesions, which may lead to increased acute phase adverse events and poor long term clinical results.

In recent years, a type of electrohydraulic lithotripsy based on the high-pressure underwater discharge technique has been used by clinicians to destroy calcified deposits or stones in the urethra or biliary tract, and therefore, the high-pressure underwater discharge technique can also be used to destroy calcified plaque in the vessel wall. One or several pairs of discharge electrodes are placed in an angioplasty balloon to form a set of pressure wave generator devices, and the electrodes are then connected to a high voltage pulse power host at the other end of the balloon dilation catheter by connectors. When the balloon is placed at a calcified lesion in a blood vessel, the system may preferentially fracture plaque through arterial soft tissue by applying a high voltage pulse to cause a pressure wave generator in the balloon to release pressure waves, also known as shock waves. After calcified plaque rupture, the coronary artery can be safely expanded under lower pressure, which creates favorable conditions for subsequent stent implantation, and the method has less trauma to normal arterial tissues. The shock wave generates local field effect, passes through soft vascular tissue, and selectively breaks the intima and medial calcified plaque in the vascular wall, thereby achieving the purpose of breaking up the calcified plaque.

However, in the process of treating calcified lesions with shock waves, a method for timely and quantitatively accurately evaluating the degree of vascular dilatation of calcified stenosis is still lacking, so that an operator may need to perform multiple shock wave lithotripsy treatments at the same position, and perform multiple coronary angiography to observe the dilatation effect of the shock wave balloon. Even if the vasodilation effect is observed through multiple coronary angiography, the optimal length and size of the implanted stent required by the dilated blood vessel still cannot be confirmed, and the blood vessel lumen image instruments such as IVUS or OCT are required to be accurately evaluated, so that the complexity of the whole PCI interventional treatment operation flow, the operation time and the cost are increased. So that the balloon catheter is difficult to quantitatively and accurately evaluate the vasodilation effect, and the optimal length and size of the implanted stent required by the dilated blood vessel are difficult to be instantly confirmed.

Disclosure of Invention

The main purpose of the present application is to provide an imageable shock wave lithotripsy balloon catheter and a use method thereof, so as to solve the problems that after the shock wave lithotripsy treatment of calcification lesions in the related technology, the quantitative and accurate assessment of the vasodilation effect is difficult, and the optimal length and size of the implanted stent required by the dilated blood vessel are difficult to confirm.

To achieve the above object, in a first aspect, the present application provides an imageable shockwave lithotripsy balloon catheter and method of use thereof, comprising:

the guiding device is used for guiding and positioning the working position; the sound wave transmitting device is arranged on the guiding device, the sound wave transmitting device is positioned on any side of the guiding device, the guiding device is provided with uniformly arranged transmitting ends, the transmitting ends are positioned in the sound wave transmitting device, and the sound wave transmitting device is guided to reach a designated position through the guiding device and is used for working treatment on a working position; and the feedback device is arranged in the sound wave transmitting device and is used for data feedback.

Further, the guiding device comprises a guide pipe, and one end of the guide pipe is provided with a Y valve.

Further, the feedback device comprises a concentration sensor arranged in the shock wave balloon, the concentration sensor is symmetrically arranged on two sides of the guiding device along the central axis of the width direction of the catheter, one end, far away from the sound wave transmitting device, of the guiding device is provided with a control end, and the control end is electrically connected with the feedback device.

Further, the acoustic wave emitting device comprises an ultrasonic micro bubble located within the shock wave balloon, the ultrasonic micro bubble routed through the Y valve.

Further, the ultrasonic transducers are arranged on the wall of the catheter in an annular array.

Further, the high-pressure ultrasonic sound pressure of the ultrasonic transducer is more than or equal to 1MPa

Further, the low-pressure ultrasonic sound pressure of the ultrasonic transducer is 500-5000Pa.

Further, the emitting end comprises electrodes which are uniformly arranged on the catheter.

Further, the control end comprises a chip, the chip is fixed outside the Y valve, and the chip is electrically connected with the emitting end and the concentration sensor.

Further, the control end comprises a host, the host is placed on one side close to the Y valve, the host is electrically connected with the transmitting end, a display device is arranged on any side of the host, and the display device is electrically connected with the host.

Further, the head end of the catheter is provided with a fixing piece, and the fixing piece is arranged in an arc shape.

Further, a hydrophilic coating is provided on the fixing member.

Further solves the technical problems that the optimal length and the optimal size of the implanted stent required by the vessel after the expansion still cannot be confirmed when the vessel expansion effect is observed through multiple times of coronary angiography in the related technology.

The advantages are that:

1. the utility model provides a shock wave rubble sacculus pipe that can image in blood vessel, is by supersound ring array transducer, microbubble concentration sensor, pipe, sacculus and diagnosis and treat the host computer and constitute. Specifically, a balloon for expanding a lesion part and a plurality of ultrasonic ring array transducers are arranged on the catheter, saline mixed with ultrasonic microbubbles is poured into the balloon, the ultrasonic microbubbles generate transient cavitation effect under high sound pressure, and the ultrasonic microbubbles burst to generate strong shock waves which are spread to the periphery for intravascular lithotripsy.

2. The ultrasonic ring array transducer can emit low-intensity ultrasonic to the periphery, ultrasonic echoes are formed by reflecting tissue structures of various layers of blood vessels, echo signals are received by the ultrasonic ring array transducer and converted into electric signals, a diagnosis and treatment host analyzes and processes the acquired signals in software, coordinate transformation (polar coordinates- - > Cartesian coordinates) is carried out, and finally, a blood vessel cross section image is displayed and provided for imaging in a body blood vessel cavity. The diagnosis and treatment host can provide high-voltage or low-voltage radio frequency energy for the ultrasonic annular array transducer, can process ultrasonic signals, and displays intravascular images on a screen for a practitioner to observe in real time, so that the calcified stenosis vasodilation degree can be evaluated in real time and quantitatively.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this application, are included to provide a further understanding of the application and to provide a further understanding of the application with regard to the other features, objects and advantages of the application. The drawings of the illustrative embodiments of the present application and their descriptions are for the purpose of illustrating the present application and are not to be construed as unduly limiting the present application. In the drawings:

FIG. 1 is a schematic structural view of an imageable shockwave lithotripsy balloon catheter provided in accordance with an embodiment of the present application;

FIG. 2 is a schematic structural view of an imageable shockwave lithotripsy balloon catheter using electrode acoustic emission states according to an embodiment of the present application;

FIG. 3 is a schematic structural view of a launching device of an imageable shockwave lithotripsy balloon catheter according to an embodiment of the present application;

FIG. 4 is a schematic structural view of a control end of an imageable shockwave lithotripsy balloon catheter according to an embodiment of the present application;

FIG. 5 is a schematic view of a portion of a structure of an imageable shockwave lithotripsy balloon catheter provided in accordance with an embodiment of the present application;

reference numerals:

1. a conduit; 12. a Y valve; 13. a shock wave balloon; 14. ultrasonic microbubbles; 15. a concentration sensor; 16. a fixing member; 17. a hydrophilic coating; 2. a control end; 21. a chip; 22. A host; 23. a display device; 3. a transmitting end; 31. an ultrasonic transducer; 32. an electrode; 4. a guide device; 5. an acoustic wave emitting device; 6. and a feedback device.

Detailed Description

In order to make the present application solution better understood by those skilled in the art, the following description will be made in detail and with reference to the accompanying drawings in the embodiments of the present application, it is apparent that the described embodiments are only some embodiments of the present application, not all embodiments. All other embodiments, which can be made by one of ordinary skill in the art based on the embodiments herein without making any inventive effort, shall fall within the scope of the present application.

It should be noted that the terms "first," "second," and the like in the description and claims of the present application and the above figures are used for distinguishing between similar objects and not necessarily for describing a particular sequential or chronological order. It is to be understood that the data so used may be interchanged where appropriate in order to describe the embodiments of the present application described herein. Furthermore, the terms "comprises," "comprising," and "having," and any variations thereof, are intended to cover a non-exclusive inclusion, such that a process, method, system, article, or apparatus that comprises a list of steps or elements is not necessarily limited to those steps or elements expressly listed but may include other steps or elements not expressly listed or inherent to such process, method, article, or apparatus.

In the present application, the terms "upper", "lower", "left", "right", "front", "rear", "top", "bottom", "inner", "outer", "middle", "vertical", "horizontal", "lateral", "longitudinal" and the like indicate an azimuth or a positional relationship based on that shown in the drawings. These terms are used primarily to better describe the present application and its embodiments and are not intended to limit the indicated device, element or component to a particular orientation or to be constructed and operated in a particular orientation.

Also, some of the terms described above may be used to indicate other meanings in addition to orientation or positional relationships, for example, the term "upper" may also be used to indicate some sort of attachment or connection in some cases. The specific meaning of these terms in this application will be understood by those of ordinary skill in the art as appropriate.

In addition, the term "plurality" shall mean two as well as more than two.

It should be noted that, in the case of no conflict, the embodiments and features in the embodiments may be combined with each other. The present application will be described in detail below with reference to the accompanying drawings in conjunction with embodiments.

The utility model provides an imageable shock wave rubble sacculus pipe, as shown in figure 1, including guiding device 4, position the pathological change position through guiding device 4, be equipped with sound wave emitter 5 on the guiding device 4, carry out the ablation through sound wave emitter 5, sound wave emitter 5 is located on arbitrary side on guiding device 4, be equipped with evenly arranged transmitting terminal 3 on the guiding device 4, work the pathological change position through evenly arranging transmitting terminal 3 on guiding device 4, transmitting terminal 3 is located in sound wave emitter 5, after guiding device 4 accomplishes, transmitting terminal 3 can butt in pathological change position department, after guiding device 4 reaches the assigned position, work the position and carry out the work; meanwhile, a feedback device 6 is arranged in the acoustic wave emitting device 5, and the ablation condition of the lesion position is subjected to feedback analysis through the feedback device 6.

As shown in fig. 1, the guiding device 4 comprises a catheter 1, a Y valve 12 is arranged at any side of the catheter 1, a guide wire 11 plays a guiding role through the Y valve 12, the sound wave transmitting device 5 comprises an ultrasonic microbubble 14, the other port of the Y valve 12 is led into the ultrasonic microbubble 14, a shock wave balloon 13 is arranged at one end of the catheter 1 far away from the Y valve 12, the ultrasonic microbubble 14 is blasted in the shock wave balloon 13, a transient cavitation effect occurs, the vibration breaking dredging of a lesion position is realized, the feedback device 6 comprises a concentration sensor 15, the concentration sensor 15 is arranged in the shock wave balloon 13, the concentration sensor 15 is symmetrically arranged at two sides in the catheter 1 along the central axis of the width direction of the catheter 1, the concentration sensor is used for detecting the concentration of the ultrasonic microbubble 14 in real time, the transmitting end 3 transmits energy, the tissue structures of all layers of blood vessels reflect to form ultrasonic echoes, the echo signals are converted into electric signals by an ultrasonic transducer 31 arranged in the shock wave balloon 13 and are fed back to the control end 2, the image is displayed, the feedback and control end 2 is displayed, the feedback and the control of the image is realized, the influence of the blood vessel cavity is displayed on the screen, the real-time observation is realized, thereby the operator can observe the vibration breaking dredging effect on the lesion position, the quantitative, the calcified stenosed blood vessel, the central vascular is symmetrically, the central axis is symmetrically along the width direction, two directions of the length of the blood vessel and the blood vessel is still the length of the blood vessel can be expanded, and the optimal coronary artery can be observed, and the length can not be observed, and the length can be observed, and the length of the stent can not be required to be observed.

As shown in fig. 1, the ultrasonic transducers 31 are arranged on the wall of the catheter 1 in an annular array, and through an annular structure, the ultrasonic transducers 31 transmit high-voltage signals to the periphery, so that the ultrasonic microbubbles 14 generate transient cavitation effect to impact the lesion, and the lesion is softened and crushed.

As shown in fig. 1, when the high-pressure ultrasound of the ultrasonic transducer 31 is greater than or equal to 1MPa and reaches 1MPa, the ultrasonic microbubbles 14 are effectively crushed by the energy emitted by the ultrasonic transducer 31, and the crushed ultrasonic microbubbles 14 generate transient cavitation effect to crush or soften calcified plaques at lesions.

As shown in fig. 1, the low-pressure ultrasonic sound pressure of the ultrasonic transducer 31 is between 500 Pa and 5000Pa, after the shock wave lithotripsy is completed, the diagnosis and treatment host 22 is excited to generate a low-pressure radio frequency signal, the low-pressure radio frequency signal is output to the annular array ultrasonic transducer 31, the annular array ultrasonic transducer 31 emits low-intensity ultrasonic to the periphery through the piezoelectric effect, and the ultrasonic echo is formed through the reflection of the tissue structures of various layers of the saccule, plaque and blood vessel. The echo signals are received by the ultrasonic array transducer and converted into electric signals, the diagnosis and treatment host computer 22 analyzes and processes the acquired signals in software, performs coordinate transformation (polar coordinates- - > Cartesian coordinates), finally displays the cross-sectional images of the blood vessels, and provides images in the body vessel cavities, so that the degree of calcified stenosis vasodilation can be estimated quantitatively in real time.

In another embodiment, as shown in fig. 2, the transmitting end 3 comprises electrodes 32, the electrodes 32 are uniformly arranged on the catheter 1, the lesion site is crushed by the electrodes 32, the shock wave balloon 13 is firstly inflated to be abutted against the lesion vascular site to generate a high-voltage pulse signal in the process of working, then the electrodes 32 release plasma discharge, shock waves are generated through the electrohydraulic effect to spread all around, the shock waves pass through soft vascular tissues, the inner membrane and the middle calcified plaque in the vascular wall are selectively cracked, after calcium plaque blocks are cracked, the vascular recovery compliance is realized, the integrated balloon expands the lesion vascular at low pressure, the lumen gain is maximized, and finally the shock waves in the vascular work along with crushed stone.

In one embodiment, as shown in fig. 4, the control end 2 includes a chip 21, the chip 21 is fixed outside the Y valve 12, the chip 21 is electrically connected with the emitting end 3 and the concentration sensor 15, the emitting end 3 is controlled by the chip 21 to emit a corresponding shock wave, and meanwhile, the concentration of the ultrasonic microbubbles 14 is feedback controlled according to the concentration sensor 15.

In another embodiment, as shown in fig. 1, the control end 2 includes a host 22, where the host 22 is placed on a side close to the Y valve 12, the host 22 is electrically connected to the transmitting end 3, and the host 22 controls the energy output of the transmitting end 3, and at the same time, the host 22 performs data control and data feedback, performs display by the display device 23, and further data processing operations, controls the transmitting end 3 with greater accuracy by the data control and data control, performs analysis processing on the acquired signal with the host 22, performs coordinate transformation (polar coordinate— > cartesian coordinate), and finally displays a blood vessel cross-section image, and provides an image in the body vessel cavity, so as to evaluate the calcified stenosis blood vessel dilation degree quantitatively.

As shown in fig. 5, the head end of the catheter 1 is provided with the fixing piece 16, and the fixing piece 16 is arranged in an arc shape, so that damage to the inner wall of a blood vessel in the process of pushing in the blood vessel can be avoided.

As shown in fig. 5, the fixing member 16 is provided with the hydrophilic coating 17, the hydrophilic coating 17 is easy to be wetted by water, pushing resistance is reduced in the pushing process, meanwhile, the hydrophilic coating 17 has good corrosion resistance, damage to the catheter 1 is reduced, and use timeliness of the catheter 1 is greatly improved.

Working principle:

the host 22 excites to generate high-voltage radio frequency signals, the high-voltage radio frequency signals are output to the annular array ultrasonic transducer 31, high-intensity ultrasonic waves are emitted to the periphery of the annular array ultrasonic transducer 31 through the piezoelectric effect and act on the ultrasonic microbubbles 14, transient cavitation effect is generated by the microbubbles, a large amount of shock waves are spread to the periphery, the shock waves penetrate through soft vascular tissues, inner membranes and middle calcified plaques in vascular walls are selectively cracked, after the shock wave lithotripsy is completed, the diagnostic host 22 controls to emit low-voltage radio frequency signals, the low-voltage radio frequency signals are output to the annular array ultrasonic transducer 31, ultrasonic echoes are formed through reflection of tissue structures of various layers of the balloon, the plaques and the blood vessels through the piezoelectric effect, the echo signals are received through the ultrasonic transducer 31 and converted into electric signals, the host 22 analyzes the received signals, and finally, and a blood vessel cross-section image is displayed.

The foregoing description is only of the preferred embodiments of the present application and is not intended to limit the same, but rather, various modifications and variations may be made by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principles of the present application should be included in the protection scope of the present application.

Claims (12)

1. An imageable shockwave lithotripsy balloon catheter, comprising:

a guiding device (4) for guiding and positioning the working position;

the sound wave transmitting device (5) is arranged on the guiding device (4), the sound wave transmitting device (5) is positioned on any side of the guiding device (4), the guiding device (4) is provided with uniformly arranged transmitting ends (3), and the transmitting ends (3) are positioned in the sound wave transmitting device (5) and guided to reach a designated position through the guiding device (4) for working treatment on a working position;

and the feedback device (6) is arranged in the sound wave emitting device (5) and is used for data feedback.

2. An imageable shockwave lithotripsy balloon catheter according to claim 1, wherein said guiding means (4) comprises a catheter (1), said catheter (1) being provided with a Y valve (12) at one end.

3. An imageable shockwave lithotripsy balloon catheter according to claim 2, wherein the feedback device (6) comprises a concentration sensor (15) arranged in the balloon (13), the concentration sensor (15) is symmetrically arranged at two sides of the guiding device (4) along the central axis of the width direction of the catheter (1), one end of the guiding device (4) far away from the sound wave emitting device (5) is provided with a control end (2), and the control end (2) is electrically connected with the feedback device (6).

4. An imageable shockwave lithotripsy balloon catheter according to claim 2, wherein said acoustic wave emitting means (5) comprises ultrasound microbubbles (14), said ultrasound microbubbles (14) being located within said balloon (13), said ultrasound microbubbles (14) being routed through said Y valve (12).

5. An imageable shockwave lithotripsy balloon catheter according to claim 1, wherein the transmitting end (3) comprises ultrasound transducers (31) arranged in an annular array on the catheter (1) wall.

6. An imageable shockwave lithotripsy balloon catheter according to claim 5, wherein the high-pressure ultrasound sound pressure of said ultrasound transducer (31) is 1MPa or more.

7. An imageable shockwave lithotripsy balloon catheter according to claim 5, wherein the ultrasound transducer (31) has a low pressure ultrasound sound pressure of 500-5000Pa.

8. An imageable shockwave lithotripsy balloon catheter according to claim 1, wherein said transmitting end (3) comprises electrodes (32), said electrodes (32) being uniformly arranged on the catheter.

9. An imageable shockwave lithotripsy balloon catheter according to claim 3, wherein said control end (2) comprises a chip (21), said chip (21) being fixed outside said Y valve (12), said chip (21) being electrically connected to said transmitting end (3) and to a concentration sensor (15).

10. An imageable shockwave lithotripsy balloon catheter according to claim 3, wherein said control end (2) comprises a host (22), said host (22) being placed on the side close to said Y-valve (12), said host (22) being electrically connected to said transmitting end (3), said host (22) being provided with display means (23) on either side, said display means (23) being electrically connected to said host (22).

11. An imageable shockwave lithotripsy balloon catheter according to claim 1, characterized in that the head end of the catheter (1) is provided with a fixing element (16), said fixing element (16) being arranged in a circular arc.

12. An imageable shockwave lithotripsy balloon catheter according to claim 11, wherein a hydrophilic coating (17) is provided on said fixture (16).

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