WO2020048274A1

WO2020048274A1 - Device for treatment of heart valve calcification and vascular calcification and method for using same

Info

Publication number: WO2020048274A1
Application number: PCT/CN2019/099128
Authority: WO
Inventors: 张一�; 黄振东; 潘孔荣; 王巍; 王旭; 郭克; 赵慧敏; 廖延标
Original assignee: 沛嘉医疗科技(苏州)有限公司
Priority date: 2018-09-03
Filing date: 2019-08-02
Publication date: 2020-03-12
Also published as: CN109223100A

Abstract

Provided are a device (1, 4, 5) for the treatment of heart valve calcification and vascular calcification and a method for using same. The device (1, 4, 5) comprises: a shock wave transmitter (10, 40) for receiving a voltage/current pulse in order to generate a shock wave; a balloon (12, 42) connected to one end of the shock wave transmitter (10, 40) in a sealed manner so that an electrolyte liquid for shock wave conduction circulates inside the shock wave transmitter (10, 40) and the balloon (12, 42); and a developing member (14, 44) located on the shock wave transmitter (10, 40) and/or the balloon (12, 42). In this way, the device can use shove waves to soften a calcified site to undertake rapid and effective treatment of the calcified site.

Description

Device for treating heart valve and blood vessel calcification and using method thereof

Technical field

The present application relates to the field of medical technology, and in particular, to a device for treating heart valves and vascular calcification and a method of using the same.

Background technique

Heart valve calcification is the main pathological manifestation of heart valve stenosis and reflux, which usually occurs in the elderly; vascular calcification is a common common atherosclerosis, hypertension, diabetic vascular disease, vascular injury, chronic kidney disease and aging. Pathological manifestations.

At present, the treatment methods for heart valve calcification and vascular calcification include drug treatment, surgical replacement or interventional surgical replacement.

The inventor of the present application found in the long-term research and development process that the existing drug treatment effect is very limited, and the existing surgical or interventional surgical replacement methods have the disadvantages of trauma and time consuming to the patient itself.

Summary of the Invention

The technical problem mainly solved by the present application is to provide a device for treating heart valve and blood vessel calcification and a method of using the same, which can use a shock wave to soften the calcification site, and can quickly and effectively complete the treatment of the calcification site.

In order to solve the above technical problem, a technical solution adopted in the present application is to provide a device for treating heart valve and blood vessel calcification, the device includes: a shock wave transmitter for receiving a voltage / current pulse to generate a shock wave; a ball A balloon is sealedly connected to one end of the shock wave transmitter, so that an electrolyte liquid that conducts the shock wave circulates in the shock wave transmitter and the balloon; a developing member is located in the shock wave transmitter and / or the shock wave transmitter Balloon.

In order to solve the above technical problem, another technical solution adopted in the present application is to provide a method for using a device for treating heart valve and vascular calcification. The method uses the device according to any one of the foregoing embodiments. The method The method includes: the device enters a human body, the shock wave emitter and / or the balloon positioning a target area to be treated under the action of the developing member; the electrolyte liquid enters the balloon through the shock wave transmitter, The shock wave transmitter transmits a shock wave, and the electrolyte liquid conducts the shock wave to the target area to be treated; after the treatment is completed, the electrolyte liquid flows out of the balloon, and the device is withdrawn from the human body.

The beneficial effects of the present application are: different from the situation of the prior art, the device for treating heart valve and vascular calcification provided by the present application includes a shock wave transmitter, a balloon, and a developing member; on the one hand, the balloon and the target to be treated In area contact, the shock wave generated by the shock wave transmitter is conducted to the target area to be treated through the electrolyte liquid in the balloon, and the calcium compound in the target area to be treated is softened and elastic under the action of the energy of the shock wave, thereby achieving the purpose of treating the calcification problem. Compared with traditional medical treatment, its treatment effect is significant; compared with traditional surgical or interventional surgical replacement, it is less invasive and time-consuming to the patient itself, for example, the valve that may be encountered during surgery The calcification is serious, and the heart valve cannot be accurately placed. The device provided by the present application can soften the calcified part, thereby facilitating the placement of the heart valve and shortening the operation time. On the other hand, the device provided in the present application also includes a developing member, which is located on the shock wave transmitter and / or the balloon, which can help the doctor locate the device and ensure that the shock wave transmitter and / or the balloon are to be treated. Target area for treatment.

[Brief Description of the Drawings]

In order to explain the technical solutions in the embodiments of the present application more clearly, the drawings used in the description of the embodiments are briefly introduced below. Obviously, the drawings in the following description are just some embodiments of the application. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without paying creative labor, of which:

1 is a schematic structural diagram of an embodiment of a device for treating heart valves and vascular calcification according to the present application;

2 is a schematic structural diagram of an embodiment of the device for treating heart valves and vascular calcification in FIG. 1 after being in contact with a target region to be treated;

3 is a schematic structural diagram of another embodiment of the device for treating heart valves and vascular calcification in FIG. 1 after being in contact with a target region to be treated;

4 is a schematic cross-sectional structure diagram of an embodiment of the conductive component in FIG. 1;

5 is a schematic structural diagram of another embodiment of a device for treating heart valve and vascular calcification according to the present application;

6 is a schematic structural diagram of another embodiment of a device for treating heart valve and blood vessel calcification according to the present application;

FIG. 7 is a schematic flowchart of an embodiment of a method for using a device for treating heart valves and vascular calcification according to the present application.

【detailed description】

In the following, the technical solutions in the embodiments of the present application will be clearly and completely described with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, but not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by a person of ordinary skill in the art without creative efforts shall fall within the protection scope of the present application.

Please refer to FIG. 1. FIG. 1 is a schematic structural diagram of an embodiment of a device for treating heart valve and vascular calcification of the present application. The device 1 includes:

Shock wave transmitter 10 is used to receive a voltage / current pulse to generate a shock wave; the energy of the shock wave can soften the position where the heart valves and blood vessels are calcified and harden or relax the adhesion site, and the shock wave will not produce healthy and elastic tissue Impact, injury, only has a therapeutic effect on the location of calcification and hardening.

The balloon 12 is hermetically connected to one end of the shock wave transmitter 10, so that the electrolyte liquid conducting the shock wave circulates in the shock wave transmitter 10 and the balloon 12; in this embodiment, the balloon 12 has a retractable, foldable and insulating property. Performance; the electrolyte liquid can be physiological saline and the like. The balloon 12 may be designed as a disposable consumable or a reuse consumable. When it is a reuse consumable, it needs to be sterilized before use.

The developing member 14 is located on the shock wave transmitter 10 and / or the balloon 12. In this embodiment, the developing member 14 can observe its position in the patient's body under the action of an external developing device (such as an X-ray imaging device, etc.).

In summary, different from the prior art, the device 1 for treating heart valve and vascular calcification provided by the present application includes a shock wave transmitter 10, a balloon 12 and a developing member 14; on the one hand, please refer to FIGS. 2 to 3 FIG. 2 is a schematic structural diagram of an embodiment of the device for treating heart valve and vascular calcification in FIG. 1 after being in contact with a target area to be treated, and FIG. 3 is the device for treating heart valve and vascular calcification in FIG. Schematic structural view of another embodiment after the treatment target area is contacted. The target region to be treated may be the

blood vessels

20, 20a, etc. in FIG. 2 and FIG. 3, as shown in FIG. 2, the calcification site 22 is located on the wall of the blood vessel 20, and as shown in FIG. 3, the calcification site 22a is located within the blood vessel 20a. The balloon 12 is in contact with the target area to be treated, and the shock wave generated by the shock wave transmitter 10 is conducted to the target area through the electrolyte liquid in the balloon 12, and the calcium compounds in the target area to be treated are softened and elastic due to the energy of the shock wave. , And then achieve the purpose of treating calcification problems. Compared with traditional medical treatment, its treatment effect is significant; compared with traditional surgical or interventional surgical replacement, it is less invasive and time-consuming to the patient itself, for example, the valve that may be encountered during surgery The calcification is serious, and the heart valve cannot be accurately placed. The device provided by the present application can soften the calcified part, thereby facilitating the placement of the heart valve and shortening the operation time. On the other hand, the device 1 provided in the present application further includes a developing member 14, which is located on the shock wave transmitter 10 and / or the balloon 12, which can help a doctor locate the position of the device and ensure the shock wave transmitter 10 and / Or the balloon 12 is treated in the target area to be treated.

In one embodiment, please continue to refer to FIG. 1. The shock wave transmitter 10 includes a first body 100 and an electrode assembly 102.

Specifically, the first body 100 includes a first end A and a second end B. The balloon 12 is hermetically connected to the first end A of the first body 100. The first body 100 communicates with the interior of the balloon 12 and forms a sealed cavity. A first hole (not shown) can be opened in the first body 100, and an external electrolyte liquid can flow into the first body 100 through the first hole, and then Flow into the balloon 12; of course, a first pipe 104 may also be provided at the first hole, and the first pipe 104 may be located outside the first body 100 and communicate with the first hole, or the first pipe 104 may extend from the outside of the first body 100 along the first hole into the inside of the first body 100. Similarly, the electrolyte liquid in the balloon 12 may flow out through the first body 100 and the first hole. The first body 100 may be formed of a flexible material. In one application scenario, the first body 100 may be retractable, foldable, and insulating. The surface of the first body 100 is curved. For example, the outer shape of the first body 100 may be a sphere, for example, a sphere, an ellipsoid, a convex sphere with an arc, and the like. In order to facilitate the device 1 to enter the target area to be treated and prevent the bacteria of the device 1 from entering the patient's body, the surface of the first body 100 is provided with a hydrophilic coating, such as a polytetrafluoroethylene PTFE coating.

The electrode assembly 102 is configured to receive a voltage / current pulse to generate a shock wave, and includes an electrode line C and an electrode D electrically connected to the electrode line C. The electrode line C extends from the inside of the first body 100 into the balloon 12 and the electrode D is located inside the balloon 12, and the electrode D is electrically connected to one end of the electrode wire C extending into the balloon 12. The electrode D may be in a sheet shape, a strip shape, or the like; the electrode wire C may be a soft material or a material having a certain stiffness. The electrode line C can be adjusted in angle by human or electric driving, so as to achieve the purpose of adjusting the angle of the electrode D. In other embodiments, the electrode assembly 102 is in the shape of a bar or a rod formed of the same material. The end of the electrode assembly 102 inside the balloon 12 is defined as the electrode D, and the part other than the electrode D is defined as the electrode wire. C. The material of the electrode wire C and the electrode D may be gold, silver, aluminum, copper, copper-clad steel wire, or the like. Of course, in this embodiment, the periphery of the electrode line C can also be wrapped with an insulation layer, which has a certain force conductivity while being insulated.

In another embodiment, the developing member 14 includes a developing ring 140, and the first end A of the first body 10 is provided with the developing ring 140; and / or, the second end B of the first body 10 is provided with the developing ring 140 (such as (Shown in FIG. 1); and / or, a developing ring 140 is provided at an end of the balloon 12 remote from the first body 10. The developing ring 140 may be made of a metal material or the like, and the developing ring 140 may be developed by an X-ray imaging device or the like. In other embodiments, the display ring 140 may be made into other shapes, such as a developing block fixed on the first body 10.

In yet another embodiment, the developing member 14 includes a developer, and the developer is mixed in the electrolyte liquid. The developer can be a developer commonly used in the existing medical technology field, and it can be developed on an X-ray imaging device or a vascular imaging device DSA. When the balloon 12 is filled with an electrolyte liquid containing a developer, the vascular imaging device can monitor the amount of the electrolyte solution in the balloon 12 through the developer. When the wall is closed, filling the balloon 12 with the electrolyte solution is stopped. In this way, on the one hand, the balloon 12 can be made as close as possible to the blood vessel wall, and on the other hand, the electrolyte solution in the balloon 12 can be prevented from being overfilled, thereby damaging the blood vessel wall.

In another embodiment, please continue to refer to FIG. 1. The device 1 provided in the present application includes at least one balloon 12 (for example, one, two, three, etc.), and each balloon 12 contains a plurality of electrodes. D (for example, one, two, three, etc.).

In one application scenario, multiple electrodes D contained in each balloon 12 are sequentially discharged. For example, the effective range of each electrode D is 120 °. In order to form an effective range of 360 °, the number of electrodes D in each balloon 12 may be three, and the three electrodes D are sequentially discharged clockwise or counterclockwise. , And then treat the target area for a comprehensive role. Of course, in other embodiments, multiple electrodes D may be discharged at the same time, which is not limited in this application.

In another application scenario, please refer to FIG. 1 and FIG. 4 together. FIG. 4 is a schematic cross-sectional structure diagram of an embodiment of the conductive component in FIG. 1. The device 1 provided in the present application further includes: a conductive component 16 for providing an extension path of the electrode wire C in the electrode component 102. The conductive component 16 extends from the outside of the first body 10 into the first body 10. In this embodiment, In the embodiment, the conductive component 16 may further extend into the balloon 12; of course, in other embodiments, the conductive component 16 may be located only in the balloon 12. The conductive component 16 is a flexible catheter. In an application scenario, the conductive component 16 includes: a first pipe body 30, the first pipe body 30 is a hollow structure; a second pipe body 32, which is located inside the first pipe body 30; and an electrode wire C between the first pipe body 30 and A middle region of the second pipe body 32 extends. Wherein, the first pipe body 30 may be formed by weaving 304 stainless steel or nickel-titanium alloy wire, and the shape of the weaving may be a spring shape or a cross-weave shape. The second tube body 32 may be a polyimide tube having a metal braid-resistant layer. In addition, in this embodiment, the inner wall or outer wall of the first pipe body 30 and / or the second pipe body 32 may be coated with a smooth polytetrafluoroethylene PTFE layer to prevent external bacteria from entering.

In another embodiment, please continue to refer to FIG. 1. The device 1 provided in the present application further includes: a shock wave generator 18, one end of which is connected to an external power source, and the other end of which is connected to the electrode assembly 102. In this embodiment, the output terminal of the shock wave generator 18 may be electrically connected to the electrode line C in the electrode assembly 102. When the shock wave generator 18 is connected to an external power source, a high-frequency voltage / current pulse can be generated. In an application scenario, the shock wave generator 18 further includes a control switch system (not shown), which can adjust the output of different currents according to the calcification degree of the target area of the patient to be treated (for example, at the valve, leaflets, blood vessels, etc. Voltage pulse intensity, repetition frequency, duration.

In another embodiment, please continue to refer to FIG. 1. The device provided in the present application may further include a reserved channel 11 that extends inside the shock wave transmitter 10 and the balloon 12 of the device 1; external metal wires enter the After the channel 11 is reserved, the forward direction of the device 1 can be guided.

The above-mentioned device for treating heart valves and vascular calcification can be applied to interventional treatments; and when patients need to be treated with surgery, a handheld device can be designed. Please refer to FIG. 5, which is a schematic structural diagram of another embodiment of a device for treating heart valve and vascular calcification of the present application. The handheld device 4 includes:

The shock wave transmitter 40 includes a first body 400 and an electrode assembly 402. The electrode assembly 402 includes an electrode E and an electrode line F electrically connected to the electrode E. The specific structure and positional relationship are the same as those in the foregoing embodiment, and details are not described herein again. It should be noted that, in FIG. 5, three electrodes E are schematically drawn, and only one electrode wire F connected to the electrode E is schematically drawn. This is because the angle of the electrode E can be arbitrary, and the electrode wires are not schematically drawn. The extending direction is a direction perpendicular to the paper surface.

The specific structure of the balloon 42 is similar to that in the above embodiment, and will not be repeated here.

The developing member 44 includes a developing ring 440 (and / or 442) and / or a developer, and the manner of setting the developing ring 440 (and / or 442) and the developer is the same as that in the above embodiment, and details are not described herein again.

The handle 46, one end of the handle 46 is connected to one end of the shock wave transmitter 40, and can be connected by screwing or engaging, for example. During the operation, the handle 46 is held by the operating doctor, and the handle 46 may be designed into an arc-shaped shape that is convenient for the operating doctor to hold. In order to reduce the possibility of the handle 46 slipping off, a concave-convex structure may be provided on the outside of the handle 46 to increase the contact area.

One end of the shock wave generator 48 is electrically connected to an external power source, and the other end thereof is electrically connected to the electrode assembly 402.

In one embodiment, a control switch system is further provided on the handle 46 or the shock wave generator 48 for adjusting the output of different currents according to the degree of calcification of the target area of the patient to be treated (for example, at the valve, leaflets, blood vessels, etc.) Voltage pulse intensity, repetition frequency, duration. An LED light source may also be provided in the above-mentioned handheld device 4, and the LED light source may be used for illumination during surgery.

In another embodiment, please continue to refer to FIG. 5. The handheld device 4 provided in the present application may further include a first pipeline 41, the first pipeline 41 communicates with the first body 400 of the shock wave transmitter 40, and the electrolyte liquid. The first body 400 can flow into or out of the first pipe 41 from the first pipe 41.

In another embodiment, please continue to refer to FIG. 5. The handheld device 4 provided in the present application may further include a reserved channel 43 that extends inside the handle 46, the shock wave transmitter 40, and the balloon 42; the outside; After the metal wire enters the reserved channel 43, it can guide the forward direction of the handheld device 4.

Please refer to FIG. 6, which is a schematic structural diagram of another embodiment of a device for treating heart valve and vascular calcification of the present application. The differences between the handheld device 5 and the handheld device 4 in FIG. 5 include: A. The shape design of the handle 50, the handle 46 in FIG. 5 is similar to the “Γ” shape structure, and the handle 50 in FIG. 6 may be a cylinder and a cylinder The diameter of each section of the body may be different; B. The handheld device 5 in FIG. 6 further includes a connection connector 52 for electrically connecting the shock wave generator (not shown in FIG. 6) with the electrode assembly 54.

Please refer to FIG. 7. FIG. 7 is a schematic flowchart of an embodiment of a method for using a device for treating heart valve and vascular calcification of the present application. The method uses the device in any one of the above embodiments. The method includes:

S101: The device enters the human body, and the shock wave transmitter and / or the balloon locate the target area to be treated under the action of the developing member; specifically, the developing member includes a developing ring, and medical personnel can pass a developing device (for example, an X-ray developing device, etc.) Observe the position of the developing ring, and then position the device on the target area to be treated.

S102: The electrolyte liquid enters the balloon through the shock wave transmitter, and the shock wave transmitter transmits the shock wave. The electrolyte liquid transmits the shock wave to the target area to be treated. Specifically, in one embodiment, the developing member includes a developing solution, and the developing agent is mixed with the electrolyte liquid. In step S02, the electrolyte liquid enters the balloon through the first body of the shock wave transmitter. The vascular imaging device monitors the amount of the electrolyte solution in the balloon, and when the balloon expands under the filling of the electrolyte solution, it closes to the target area. Vessel wall, stop filling the balloon with electrolyte solution. In this way, on the one hand, the balloon can be made as close to the blood vessel wall as possible, and on the other hand, the electrolyte solution in the balloon can be prevented from being overfilled, thereby damaging the blood vessel wall.

S103: After the treatment is completed, the electrolyte liquid flows out of the balloon, and the device is withdrawn from the human body.

The methods provided above are suitable for interventional and surgical procedures.

Taking interventional surgery as an example, the working process of the device shown in Figure 1 is as follows: The device for treating heart valves and vascular calcification is passed through a hemostatic valve by a delivery system and enters the human body along the path of an access product (such as a guide catheter), Under the action of the imaging ring, it is sent to the target area to be treated; under the action of the vascular imaging device DSA, the balloon is expanded and close to the blood vessel wall under the filling of the electrolyte solution containing the developer; the control switch system is opened to adjust the parameters and the shock wave The transmitter starts to work and launches a shock wave to treat the target area to be treated. After the treatment is completed, the electrolyte solution containing the developer in the balloon flows out of the balloon to release the balloon pressure; the device is withdrawn through the access product (such as a guide catheter) To complete the treatment process.

Taking surgery as an example, the above device can be a handheld device (such as the device shown in FIG. 4). The working process of the above device is as follows: After the patient opens the chest through surgery, an incision is made on the heart. The established path enters the heart and reaches the target area under the action of the imaging ring; under the action of the vascular imaging device DSA, the balloon expands and closes to the vessel wall under the filling of the electrolyte solution containing the developer; opening control Switch the system, adjust the parameters, the shock wave transmitter starts to work and launch the shock wave, and treat the target area to be treated; after the treatment is completed, the electrolyte solution containing the developer in the balloon flows out of the balloon to release the pressure of the balloon; Guide catheter) to withdraw the device and complete the treatment process.

The above is only an implementation of the present application, and does not limit the patent scope of the present application. Any equivalent structure or equivalent process transformation made by using the description and drawings of the present application, or directly or indirectly applied to other related technologies The fields are equally included in the patent protection scope of this application.

Claims

A device for treating heart valve and vascular calcification, characterized in that the device includes:

Shock wave transmitter for receiving voltage / current pulses to generate shock waves;

A balloon that is sealedly connected to one end of the shock wave transmitter so that an electrolyte liquid that conducts the shock wave circulates in the shock wave transmitter and the balloon;

The developing member is located on the shock wave transmitter and / or the balloon.
The apparatus according to claim 1, wherein the shock wave transmitter comprises:

The first body includes a first end and a second end, wherein the balloon is hermetically connected to the first end of the first body;

An electrode assembly for receiving a voltage / current pulse to generate a shock wave, including an electrode line and an electrode electrically connected to the electrode line, the electrode line extending from the inside of the first body into the balloon, and The electrode is located in the balloon and is electrically connected to an end of the electrode wire extending into the balloon.
The device according to claim 2, wherein the developing member includes a developing ring, and the first end of the first body is provided with the developing ring; and / or, a portion of the first body The second end is provided with the developing ring; and / or, the electrode is provided with the developing ring.
The device according to claim 2, wherein the developing member includes a developer, and the developer is mixed in the electrolyte liquid; the first body is provided with a first hole, and the electrolyte liquid passes through The first hole flows into / out of the first body.
The device according to claim 2, wherein the device comprises at least one of the balloons, each of which contains a plurality of electrodes.
The device according to claim 5, wherein a plurality of the electrodes contained in each of the balloons are sequentially discharged.
The apparatus according to claim 2, further comprising:

A conductive component for providing an extension path of an electrode wire in the electrode component, the conductive component includes: a first tube body, the first tube body is a hollow structure; a second tube body, located in the first tube body internal;

Wherein, the electrode wire extends in a middle region between the first tube body and the second tube body.
The apparatus according to claim 2, further comprising:

One end of the shock wave generator is electrically connected to an external power source, and the other end thereof is electrically connected to the electrode assembly.
The device according to claim 2, wherein the first body is formed of a flexible material, and / or the surface of the first body is curved; and / or, the surface of the first body is provided with Hydrophilic coating.
The device according to claim 1, further comprising a handle, one end of the handle being connected to one end of the shock wave transmitter.
The device according to claim 1 or 10, wherein the device further comprises a reserved channel extending inside the handle, the shock wave transmitter, and the balloon.
A method for using a device for treating heart valve and vascular calcification, wherein the method uses the device according to any one of claims 1-11, and the method includes:

The device enters the human body, the shock wave transmitter and / or the balloon locate the target area to be treated under the action of the developing member;

The electrolyte liquid enters the balloon through the shock wave transmitter, the shock wave transmitter emits a shock wave, and the electrolyte liquid conducts the shock wave to the target area to be treated;

After the treatment is over, the electrolyte fluid flows out of the balloon and the device is withdrawn from the body.
The method according to claim 12, wherein the developing member comprises a developer, the developer is mixed in the electrolyte liquid, and the electrolyte liquid enters through the first body of the shock wave transmitter. The balloon includes:

The vascular imaging device monitors the amount of the electrolyte solution in the balloon, and when the balloon expands under the filling of the electrolyte solution and closes to the blood vessel wall of the target area, it stops filling the balloon. The electrolyte solution.
The method according to claim 12, wherein the method is suitable for interventional surgery and surgery.