CN219021398U

CN219021398U - Pressure wave saccule catheter integrated with pulse focusing ultrasound

Info

Publication number: CN219021398U
Application number: CN202221326070.2U
Authority: CN
Inventors: 江挺益; 刘广志
Original assignee: Suzhou Rainmed Medical Technology Co Ltd
Current assignee: Suzhou Shengke Intelligent Technology Co ltd
Priority date: 2022-05-30
Filing date: 2022-05-30
Publication date: 2023-05-16
Anticipated expiration: 2032-05-30

Abstract

The application relates to the technical field of medical equipment, in particular to a pressure wave balloon catheter integrating pulse focusing ultrasound. The guide wire is arranged in the guide tube, and slides along the length direction of the guide tube, and a Y valve is arranged at any end of the guide tube; the control end is arranged at one side of the Y valve; the shock wave balloon is arranged on one side of the catheter, which is far away from the Y valve, and is electrically connected with the control end; the ultrasonic focusing transducer is arranged at one end of the catheter far away from the Y valve, the whole structure of the ultrasonic focusing transducer is bowl-shaped, and the control end is electrically connected with the ultrasonic focusing transducer. Solves the problem that the shock wave or pressure wave balloon can not pass through the lesion for the lesion which has serious stenosis or the complete occlusion lesion, so that the work can not be performed.

Description

Pressure wave saccule catheter integrated with pulse focusing ultrasound

Technical Field

The application relates to the technical field of medical equipment, in particular to a pressure wave balloon catheter integrating pulse focusing ultrasound.

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.

For heavily calcified plaque, doctors often prepare lesions before stent implantation, there are mainly two treatment schemes-high pressure balloon dilation or plaque rotational abrasion-but both have respective limitations and safety hazards. High pressure balloon dilation is the most common treatment, and the vessel is further dilated by rupturing the calcified lesions by high pressure compression. However, high pressure balloons often do not expand well against thicker annular calcifications, potentially resulting in tearing of soft tissue and even perforation of the artery. Another approach is plaque rotational atherectomy, which uses a micro-drill rotating at speeds in excess of 125k RPM in the artery to dilate the lumen of the artery, which requires a high level of skill by the operator, which is difficult to perform in the patient's coronary arteries unless performed regularly, and which is prone to distal occlusion and perforation of the artery. Although this treatment has been in existence for decades, it is not used frequently (less than 5% of all stent surgeries) due to its complexity and possible adverse consequences.

However, in the treatment of calcified lesions, shock or pressure wave balloons still present a problem, and for lesions that have developed severe stenosis or fully occluded lesions, the shock or pressure wave balloons may not pass through the lesion, resulting in the inability of the procedure to proceed. Therefore, the shock wave or pressure wave balloon catheter adopted in the prior art needs to be perfected, and is a research difficult problem that the current medical instrument manufacturers need to improve.

Disclosure of Invention

The main objective of the present application is to provide a pressure balloon catheter integrated with pulse focused ultrasound, so as to solve the problem that in the related art, for a lesion where severe stenosis has occurred or a completely occluded lesion, a shock wave or pressure wave balloon may not pass through the lesion, resulting in incapacity of operation.

To achieve the above object, in a first aspect, the present application provides a pressure wave balloon catheter integrating pulsed focused ultrasound, comprising:

the guiding device is used for guiding and positioning the working position; the balloon is arranged on the guiding device, wraps the guiding device and is used for abutting against the lesion position after guiding and positioning; the ultrasonic focusing transducer is arranged at one end of the guiding device, which is close to the balloon, and is used for ultrasonic heating.

Further, the guiding device comprises a guide pipe, a guide wire is arranged in the guide pipe, the guide wire penetrates through the guide pipe and slides along the length direction of the guide wire, and a Y valve is arranged at any end of the guide pipe.

Further, a control end is provided on either one of the guide devices.

Further, the whole structure of the ultrasonic focusing transducer is bowl-shaped, and the control end is electrically connected with the ultrasonic focusing transducer.

Further, the balloon is positioned on one side of the catheter, which is far away from the Y valve, and the balloon is electrically connected with the control end.

Further, the ultrasonic focusing transducer comprises a cathode coating, the cathode coating is positioned on one side of the recess of the ultrasonic focusing transducer, and an anode coating is arranged on one side of the projection of the ultrasonic focusing transducer.

Further, the interface of the negative electrode coating is positioned on one side of the positive electrode coating.

Further, the center of the ultrasonic focusing transducer is provided with an empty groove, the empty groove penetrates through the cross section of the ultrasonic focusing transducer, and the guide wire slides in the empty groove to extend to the front end of the ultrasonic focusing transducer.

Further, the empty slot area is less than or equal to one quarter of the ultrasonic focusing transducer area.

Further, the ultrasonic focusing transducer is made of piezoelectric ceramics.

Further, a plurality of transmitting devices are arranged in the balloon.

Further, the balloon is wrapped on the catheter in a tubular shape.

Further, the control end comprises a chip, and the chip is electrically connected with the transmitting device.

Further, the control end comprises a host, and the host is electrically connected with the transmitting device.

Further, the emitting device comprises a plurality of electrodes, and the electrodes are uniformly arranged on the catheter.

Further, the transmitting device comprises ultrasonic transducers which are uniformly arranged on the catheter, and ultrasonic microbubbles are arranged in the balloon.

Further, the ultrasonic transducer is annularly wrapped around the catheter.

Further, a sensor is placed on the catheter, the sensor is located within the balloon, and the sensor is placed on the catheter.

The advantages are that:

1. an ultrasonic focusing transducer for opening the vascular lesion is arranged at the front end of the saccule catheter. In the process of stretching the balloon catheter into a lesion site, when the clinical blood vessel is severely stenosed or completely occluded, a focusing ultrasonic transducer at the head end of the catheter is arranged in front of the stenosed or occluded site, and the ultrasonic focusing transducer is started to emit high-intensity pulse ultrasonic forward, so that shock waves are generated at the position close to the stenosed or occluded site. High-intensity continuous ultrasound can be emitted forward to generate thermal effect.

2. The utility model provides an integrated pulse focusing ultrasonic pressure wave sacculus pipe, through mechanical effect, cavitation effect, the thermal effect of supersound of fusion shock wave to progressively open the occlusion position in the blood vessel, thereby make shock wave sacculus can move to pathological change position smoothly, restart the rubble electrode in the shock wave sacculus, release shock wave shake garrulous calcified plaque to pathological change position, resume the vascular compliance, in order to reach the treatment purpose.

3. The utility model provides an integrated pulse focusing ultrasonic pressure wave sacculus pipe, ultrasonic focusing transducer can effectively improve the trafficability characteristic of sacculus pipe at vascular lesion position, especially serious stenosis and complete occlusion's pathological change to promote the feasibility of this treatment operation reply complicated pathological change, finally expand this treatment operation possible adaptation disease.

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 a pressure wave balloon catheter integrated with pulsed focused ultrasound according to an embodiment of the present application;

FIG. 2 is a schematic diagram of the structure of an ultrasonic focus transducer of a pressure wave balloon catheter integrated with pulsed focused ultrasound according to an embodiment of the present application;

FIG. 3 is a schematic diagram of a pressure wave balloon catheter using ultrasound microbubble ablation status for integrated pulse focused ultrasound according to an embodiment of the present application;

FIG. 4 is a schematic structural view of a transmitting device of a pressure wave balloon catheter integrated with pulsed focused ultrasound according to an embodiment of the present application;

FIG. 5 is a schematic structural view of a control end of a pressure wave balloon catheter incorporating pulsed focused ultrasound according to an embodiment of the present application;

reference numerals:

1. a conduit; 10. a guide device; 11. a guide wire; 12. a Y valve; 13. a balloon; 14. an ultrasonic focusing transducer; 141. a negative electrode coating; 142. a positive electrode coating; 143. a hollow groove; 2. a control end; 21. a chip; 22. a host; 3. a transmitting device; 31. an electrode; 32. An ultrasonic transducer; 33. ultrasonic microbubbles; 34. a sensor.

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.

As shown in fig. 1, the guiding device 10 provides guiding operation before operation in the working process, part of the positions on the guiding device 10 are provided with the balloon 13, the balloon 13 wraps the guiding device 10, when the balloon 13 reaches the working position according to the guiding device 10, the temperature rising operation of the lesion position is processed, the ultrasonic focusing transducer 14 is arranged at one end, close to the balloon 13, of the guiding device 10, and obstacle clearing is carried out on the position, which is guided by the blocking guiding device 10, of the ultrasonic transducer 14.

As shown in fig. 1, a guide wire 11 is disposed in a catheter 1, the guide wire 11 passes through the catheter 1, the guide wire 11 slides along the length direction of the guide wire, the guide wire 11 is led into a shock wave balloon 13 through the other port of a Y valve 12, a Y valve 12 is disposed on any side of the catheter 1, the shock wave balloon 13 is disposed on one side of the catheter 1, which is far away from the Y valve 12, to convey the shock wave balloon 13 to a lesion site for heating treatment, a control end 2 is disposed on one side of the Y valve 12, the control end 2 is electrically connected with the shock wave balloon 13, the shock wave balloon 13 is controlled by the control end 2 for heating treatment of the lesion site, an ultrasonic focusing transducer 14 is disposed on one end of the catheter 1, which is far away from the Y valve 12, and the ultrasonic energy is focused on a central axis through a bowl-shaped structure, to generate shock waves to a focusing area on a focusing line, thereby realizing the function of shattering the front calcified plaque.

As shown in fig. 2, the ultrasonic focusing transducer 14 includes a cathode coating 141, the cathode coating 141 is disposed at a concave side of the ultrasonic focusing transducer 14, and a positive electrode coating 142 is disposed at a convex side of the ultrasonic focusing transducer 14 to form a pulse, and the high-intensity pulse ultrasonic wave is emitted forward through the cathode coating 141, so that the mechanical effect, cavitation effect and thermal effect of the ultrasonic wave of the shock wave are fused, and the occlusion part in the blood vessel is gradually opened, so that the shock wave balloon 13 can smoothly move to the lesion part.

As shown in fig. 2, the interface of the negative electrode coating 141 is disposed on one side of the positive electrode coating 142, so that the interfaces of the negative electrode and the positive electrode are located on the same side, which facilitates the power input on the same side, reduces redundant wiring, and meanwhile, the interface reduces the occurrence of failure fault tolerance rate of the apparatus because the side of the positive electrode coating 142 is not exposed to blood.

As shown in fig. 2, a hollow groove 143 is arranged at the center of the ultrasonic focusing transducer 14, the hollow groove 143 penetrates through the cross section of the ultrasonic focusing transducer, the guide wire 11 slides from the hollow groove 143 to extend to the front end of the ultrasonic focusing transducer 14, and when the ultrasonic focusing transducer 14 generates shock waves, plaque in front of the catheter 1 is penetrated together by the broken stone effect of the shock waves.

As shown in FIG. 2, the area of the empty slot 143 is less than or equal to one fourth of the area of the ultrasonic focusing transducer 14, and the area of the empty slot 143 is not easy to be larger, and the excessive shock wave energy of the ultrasonic focusing transducer 14 is insufficient to break up plaque at lesion sites, thereby affecting the intensity of the shock wave of the ultrasonic transducer.

As shown in fig. 2, the ultrasonic focusing ultrasonic transducer 32 is made of piezoelectric ceramics, and bound charges appear at two ends of a polarized piezoelectric ceramic sheet, and a layer of free charges from the outside is adsorbed on the surface of the electrode 31. When an external pressure F is applied to the ceramic sheet, discharge occurs at both ends of the sheet. Charging occurs when pulling forces are applied in opposite directions. The phenomenon of this mechanical effect being converted into an electrical effect belongs to the positive voltage effect. Piezoelectric ceramics have spontaneous polarization properties, and spontaneous polarization can be converted under the action of an external electric field.

As shown in fig. 1, a plurality of transmitting devices 3 are arranged in the shock wave balloon 13, and shock waves are transmitted by the transmitting devices 3, so that the shock waves transmitted by the balloon perform shattering shock heating treatment on the lesion position.

In one embodiment, as shown in fig. 2, the shock wave balloon 13 is wrapped on the catheter 1 in a tubular shape, so that the catheter 1 is conveniently and rapidly introduced when the catheter 1 is introduced into a blood vessel, and meanwhile, the contact area with blood can be reduced by wrapping and attaching the shock wave balloon 13 on the catheter 1, so that the relative resistance is reduced, and the catheter 1 is effectively advanced and placed at a lesion.

As shown in fig. 5, the control end 2 includes a chip 21, and the chip 21 is electrically connected to the emitting device 3, so that a medical staff can effectively control the emitting device 3 through the operation of the control end 2.

In another embodiment, as shown in fig. 5, the control end 2 includes a host 22, and performs data control and data feedback through the host 22, and further data processing operations, and controls the transmitting device 3 through data control and data control with greater accuracy, and performs a more accurate transmission heating process.

In one embodiment, as shown in fig. 4, the emitting device 3 comprises a plurality of electrodes 31, the electrodes 31 are uniformly arranged on the catheter 1, the temperature of a lesion site is raised through the electrodes 31, in the process of needing treatment, the shock wave balloon 13 is firstly inflated to be abutted against the lesion vascular site to generate a high-voltage pulse signal, then the electrodes 31 release plasma discharge, shock waves are generated through the electrohydraulic effect to spread all around, the shock waves penetrate 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 are operated along with the lithotriptic operation.

In another embodiment, as shown in fig. 4, an ultrasonic transducer 32 is arranged in a shock wave balloon 13, ultrasonic transducers are uniformly arranged on a catheter 1, ultrasonic microbubbles 33 are continuously introduced into the balloon through a Y valve 12, the ultrasonic microbubbles 33 generate transient cavitation effect under the high sound pressure of the ultrasonic transducer 32, the ultrasonic microbubbles 33 burst to generate strong shock waves, and the strong shock waves are spread around for lithotripsy at vascular lesions.

As shown in fig. 4, the ultrasonic transducer 32 is in a ring-shaped structure to wrap the catheter 1, and the ultrasonic transducer 32 transmits a high-voltage signal to the periphery through the ring-shaped structure, so that the ultrasonic microbubbles 33 generate transient cavitation effect, impact heating treatment is performed on the lesion, and the lesion is softened and crushed.

As shown in fig. 4, the catheter 1 is provided with a sensor 34, the sensor 34 is displaced in the impact ball bag, the sensor 34 is positioned in the impact wave balloon 13, a plurality of microbubble concentration sensors 34 are arranged in the balloon, the sensors are connected with the catheter 1 through wires, and when the balloon is filled with liquid, the microbubble concentration sensors 34 can suspend in the balloon to detect the concentration of ultrasonic microbubbles 33.

Working principle:

an ultrasonic focusing transducer 14 is integrated at the head end of the catheter 1, emitting high-intensity pulsed ultrasound forward. The high-intensity pulsed ultrasound can be focused at a specific distance from the head end of the catheter 1 to form a focal zone, and a very high peak pressure is generated in the focal zone for a short time, and the pressure can cause inertial expansion and collapse of cavitation bubbles in blood, so that cavitation effect is caused, and then shock waves are generated at the focal zone, so that the vibration and crushing effect on the front calcified plaque are realized. The ultrasonic focusing transducer 14 can also emit high-intensity continuous ultrasonic forward to generate a thermal effect in the focal zone, thereby realizing the softening effect on the lipid plaque. At the same time, the ultrasonic focusing transducer 14 is provided with a hole in the center, so that the guide wire 11 is allowed to pass out of the center hole, the guide wire 11 can be used for guiding a balloon in place conventionally, and can be matched with the ultrasonic focusing transducer 14 to "punch" plaque in front of the catheter 1 together by means of the lithotripsy effect of shock waves. So as to gradually open the occlusion part in the blood vessel, thereby enabling the shock wave saccule 13 to smoothly move to the lesion part and completing the subsequent lithotripsy heating treatment. 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

1. A pressure wave balloon catheter integrating pulsed focused ultrasound, comprising;

a guiding device (10) for guiding and positioning the working position;

the balloon (13) is arranged on the guiding device (10), and the balloon (13) wraps the guiding device (10) and is used for abutting against a lesion position after guiding and positioning;

an ultrasonic focusing transducer (14) is arranged on one end of the guiding device (10) close to the balloon (13) and is used for transmitting forward acoustic energy.

2. A pressure wave balloon catheter integrated with pulsed focused ultrasound according to claim 1, characterized in that the guiding means (10) comprises a catheter (1), a guide wire (11) is arranged in the catheter (1), the guide wire (11) slides through the catheter along the length direction thereof, and a Y valve (12) is arranged at either end of the catheter (1).

3. A pressure wave balloon catheter integrated with pulsed focused ultrasound as claimed in claim 2, characterized in that either of the guiding means (10) is provided with a control end (2).

4. A pressure wave balloon catheter integrated with pulsed focused ultrasound as claimed in claim 3, characterized in that the ultrasound focusing transducer (14) is bowl-shaped in its overall structure, and the control end (2) is electrically connected to the ultrasound focusing transducer (14).

5. A pressure wave balloon catheter integrated with pulsed focused ultrasound as claimed in claim 3, characterized in that the balloon (13) is located on the side of the catheter remote from the Y valve (12), the balloon (13) being electrically connected to the control end (2).

6. A pressure wave balloon catheter integrating pulsed focused ultrasound as claimed in claim 4, wherein the ultrasound focusing transducer (14) comprises a negative electrode coating (141), the negative electrode coating (141) being located on a concave side of the ultrasound focusing transducer (14) and a positive electrode coating (142) being located on a convex side of the ultrasound focusing transducer (14).

7. The pressure wave balloon catheter of claim 6, wherein the interface of the negative electrode coating (141) is located on the positive electrode coating (142) side.

8. A pressure wave balloon catheter integrated with pulsed focused ultrasound as claimed in claim 6, characterized in that the ultrasound focusing transducer (14) is provided with a hollow (143) at its central position, the hollow (143) extending through the cross section of the ultrasound focusing transducer (14), the guide wire (11) sliding from the hollow (143) to the front end of the ultrasound focusing transducer (14).

9. The pressure wave balloon catheter of integrated pulsed focused ultrasound of claim 8 in which the void (143) area is less than or equal to one quarter of the ultrasound focusing transducer (14) area.

10. A pressure wave balloon catheter integrating pulsed focused ultrasound as claimed in claim 8, wherein the ultrasound focusing transducer (14) is made of piezoelectric ceramics.

11. A pressure wave balloon catheter integrating pulsed focused ultrasound as claimed in claim 5, characterized in that a number of transmitting means (3) are provided in the balloon (13).

12. An integrated pulse focused ultrasound pressure wave balloon catheter as claimed in claim 2, wherein the balloon (13) is wrapped in a tubular shape over the catheter (1).

13. A pressure wave balloon catheter integrated with pulsed focused ultrasound as claimed in claim 11, characterized in that the control end (2) comprises a chip (21), the chip (21) being electrically connected with the transmitting means (3).

14. An integrated pulse focused ultrasound pressure wave balloon catheter according to claim 13, wherein the control end (2) comprises a host (22), the host (22) being electrically connected to the transmitting means (3).

15. A pressure wave balloon catheter integrated with pulsed focused ultrasound as claimed in claim 13, characterized in that the transmitting means (3) comprises several electrodes (31), which electrodes (31) are uniformly arranged on the catheter (1).

16. A pressure wave balloon catheter integrating pulsed focused ultrasound as claimed in claim 13, characterized in that the transmitting means (3) comprises ultrasound transducers (32), said ultrasound transducers (32) being uniformly arranged on the catheter (1), and that ultrasound microbubbles (33) are provided in the balloon (13).

17. A pressure wave balloon catheter integrated with pulsed focused ultrasound as claimed in claim 16, characterized in that the ultrasound transducer (32) is ring-shaped around the catheter (1).

18. An integrated pulse focused ultrasound pressure wave balloon catheter as claimed in claim 17, wherein a sensor (34) is placed on the catheter (1), the sensor (34) being located within the balloon (13), the sensor (34) being placed on the catheter (1).