WO2020192146A1

WO2020192146A1 - Ultrasound balloon catheter assembly, catheter system and usage method

Info

Publication number: WO2020192146A1
Application number: PCT/CN2019/118641
Authority: WO
Inventors: 王卫
Original assignee: 苏州思维医疗科技有限公司
Priority date: 2019-03-22
Filing date: 2019-11-15
Publication date: 2020-10-01
Also published as: CN109953799A

Abstract

An ultrasound balloon catheter assembly, comprising a catheter (1) and an inflatable balloon (2) provided on the catheter (1); the catheter (1) axially passes through an inner cavity of the balloon (2) and is used for introducing a fluid into the inner cavity of the balloon (2), the peripheral part of the balloon (2) and the catheter (1) are provided with a seal therebetween; and said catheter assembly further comprises an ultrasound generating element (3) capable of emitting ultrasounds, and the ultrasound generating element (3) is provided on the catheter (1) and located in the inner cavity of the balloon (2). When the ultrasound balloon catheter assembly is used to remove intravascular calcified plaque, it is only required to introduce a fluid to fill the balloon (2) and then activate the ultrasound generating element (3), enabling the ultrasound generating element to emit ultrasounds which can directly act on the intravascular calcified plaque through the fluid and the balloon (2), thereby achieving the purpose of removing the intravascular calcified plaque. Said method achieves a good transmittance, a more direct removal of calcified plaque, and a good safety.

Description

Ultrasonic balloon catheter assembly, catheter system and use method

Technical field

The invention relates to an ultrasonic balloon catheter assembly, a catheter system and a use method, in particular to an ultrasonic balloon catheter assembly, a catheter system and a use method for removing calcified substances in blood vessels.

Background technique

Vascular calcification refers to calcium deposits in the walls of arteries and veins, that is, calcified spots on the inner walls of arteries and veins, which seriously threaten the health of patients.

In recent years, for calcium deposits in blood vessels, a catheter with a balloon is usually inserted into a blood vessel through a small operation, and the balloon is expanded when the balloon reaches the calcium deposit, and the balloon is arranged in the balloon. The electrodes work to release high-voltage pulses to form shock waves, which propagate through the fluid and hit the balloon wall and calcified areas to use the repeated pulses to destroy calcium deposits.

The US Shockwave Medical Company (SHOCKWAVE MEDICAL) provides a variety of implementation solutions for the principle of using shock waves to remove calcium deposits. For example, US patent publication numbers such as US8728091B2, US8888788 B2, US8956371 B2, US8956374 B2, US9011462, etc. This kind of shock wave removes calcified plaques in human blood vessels. It needs to generate higher high-pressure pulses in the human body, and through the generated pulses to promote the formation of bubbles in the liquid filled in the balloon, so that the bubbles act on the balloon wall when they burst. , And then act on the calcified plaque. However, the thickness of the blood vessels at different positions on the same blood vessel in the human body is not the same, and if the shock wave generated by the pulse is too large, it will cause a certain degree of damage to the blood vessel. Therefore, the above-mentioned technology of using pulse to eliminate calcified plaque in the human body does not It has not been used clinically, and at present, how to safely and effectively remove calcified plaques in blood vessels is still a major technical problem.

Summary of the invention

The first object of the present invention is to provide an ultrasound balloon catheter assembly that can safely and effectively remove calcified plaques in blood vessels.

In order to achieve the above objective, the technical solution adopted by the present invention is: an ultrasonic balloon catheter assembly, comprising a catheter and an inflatable balloon arranged on the catheter, the catheter passing through the balloon in the axial direction The cavity is used to pass fluid into the inner cavity of the balloon, and the circumference of the balloon is sealed with the catheter. The catheter assembly also includes an ultrasonic generating element capable of emitting ultrasonic waves. The element is arranged on the catheter and located in the inner cavity of the balloon.

Preferably, the catheter assembly further includes a connecting wire connected to the ultrasonic generating element, and the other end of the connecting wire passes out to the outside of the balloon.

Preferably, the ultrasonic generating elements are arranged in multiple groups at intervals along the length extension direction of the catheter.

Preferably, the ultrasonic generating element is an ultrasonic chip element capable of emitting ultrasonic waves.

Preferably, the ultrasonic generating element is fixedly arranged on the catheter through a carrier ring.

Further, the carrier ring is fixedly sleeved on the catheter, and the carrier ring is provided with a supporting platform, and the ultrasonic generating element is fixedly provided on the supporting platform.

Furthermore, the carrier ring is a platinum ring or a 316 stainless steel ring.

Furthermore, the carrier ring is a ceramic ring plated with a gold layer on the surface. As a preferred embodiment, the material of the ceramic ring is aluminum trioxide or aluminum zirconate titanate.

As a preferred solution, the ultrasonic generating elements are arranged in multiple groups at intervals along the length of the catheter, the ultrasonic generating elements are ultrasonic chip elements that can emit ultrasonic waves, and each of the ultrasonic chip elements passes through A carrier ring is fixedly arranged on the catheter, the catheter assembly further includes a connecting wire connected to the ultrasonic generating element, and the other end of the connecting wire penetrates out of the balloon.

As a specific embodiment, the carrier ring is a platinum ring.

The second object of the present invention is to provide an ultrasonic balloon catheter system.

In order to achieve the above objective, the technical solution adopted by the present invention is: an ultrasonic balloon catheter system, including the above-mentioned ultrasonic balloon catheter assembly, and also including an ultrasonic control generator for controlling the working state of the ultrasonic generating element, and A power source, and the ultrasonic generating element is connected to the ultrasonic control generator through a connecting wire that passes out of the balloon.

The third object of the present invention is to provide a method of using the above-mentioned ultrasonic balloon catheter assembly.

In order to achieve the above-mentioned objective, the technical solution adopted by the present invention is: a method of using an ultrasonic balloon catheter assembly, using the above-mentioned ultrasonic balloon catheter assembly, and the method of use includes:

(1) Send the balloon to a preset position via the catheter;

(2) Inject fluid into the catheter and make the balloon inflated after being filled with the fluid;

(3) Control the ultrasonic generating element to emit ultrasonic waves.

Preferably, the working frequency of the ultrasonic generating element is 20KHz-2MHz.

Preferably, the working voltage of the ultrasonic generating element is 350-500V.

Due to the application of the above technical solutions, the present invention has the following advantages compared with the prior art: The ultrasound balloon catheter assembly of the present invention, in which the catheter attached with the balloon is provided with an ultrasound generating element capable of emitting ultrasound, which is used to remove In the case of intravascular calcification plaques, you only need to inject fluid to make the balloon inflate and activate the ultrasonic generating element, which can make it emit ultrasonic waves directly through the fluid and the balloon to directly act on the vascular calcification plaques, thereby removing vascular calcification plaques Its purpose is to have good transmittance, to remove calcified spots more directly, and the ultrasonic waves generated during the working process will not cause harm to the human body.

Description of the drawings

Figure 1 is a three-dimensional schematic diagram of the ultrasound balloon catheter assembly of the present invention;

Figure 2 is a schematic front view of the ultrasound balloon catheter assembly of the present invention;

Fig. 3 is a schematic sectional view of the structure along the A-A direction in Fig. 2;

Fig. 4 is an enlarged schematic diagram of the structure of part B in Fig. 3;

Figure 5 is a schematic cross-sectional view of the structure along the line C-C in Figure 4;

Figure 6 is a schematic structural diagram of the ultrasound balloon catheter system of the present invention;

Among them: 1. Catheter; 2. Balloon; 3. Ultrasonic generating element (ultrasonic chip element); 4. Support ring; 41. Opening; 42, straight section; 5. Connecting wire; 6. Ultrasonic control generator; 7. ,power supply.

detailed description

The technical solution of the present invention will be further explained below in conjunction with the drawings and specific implementations.

Referring to Figures 1 to 5, an ultrasonic balloon catheter assembly includes a catheter 1 and an inflatable balloon 2 arranged on the catheter 1. The catheter 1 passes through the inner cavity of the balloon 2 in the axial direction and is used for Fluid is introduced into the inner cavity of the balloon 2, the circumference of the balloon 2 and the catheter 1 are sealed, and the balloon 2 is inflated after being filled with fluid. During the specific installation, the tube section of the catheter 1 located in the inner cavity of the balloon 2 is densely provided with micropores, so that when fluid is passed into the catheter 1, the fluid will enter the balloon 2 through the aforementioned micropores. The cavity, so that the balloon 2 is filled with fluid and then expanded.

The catheter assembly also includes an ultrasonic generating element 3 capable of emitting ultrasonic waves. The ultrasonic generating element 3 is arranged on the catheter 1 and located in the inner cavity of the balloon 2. The ultrasonic generating elements 3 may be one set, or multiple sets may be provided at intervals along the longitudinal extension direction of the catheter 1.

The catheter assembly also includes a connecting wire 5 connected to the ultrasonic generating element 3, and the other end of the connecting wire 5 penetrates to the outside of the balloon 2 for connecting with an ultrasonic control generator (not shown in the figure). Control the working state of the ultrasonic generating element 3, such as the start and stop of the ultrasonic generating element 3, the frequency of the ultrasonic wave, the working voltage and so on. Specifically, the ultrasonic generating element 3 may be an ultrasonic chip element capable of emitting ultrasonic waves.

Referring to Figures 4 and 5, the ultrasonic generating element 3 is fixedly arranged on the catheter 1 through the carrier ring 4. In this embodiment, the carrier ring 4 is fixedly sleeved on the catheter 1, and there is a supporting platform on it. The ultrasonic generating element 3 is fixedly arranged on the supporting platform. Specifically, the carrier ring 4 includes a main body ring part that cooperates with the catheter 1 and has a U-shaped cross-section, and a straight section 42 extending from opposite ends of the main body ring part, and an opening 41 is formed between the two straight sections 42 And the two straight sections 42 together form the aforementioned supporting platform, and the ultrasonic generating element 3 is fixedly installed on the two straight sections 42 and is fixedly carried by the carrier ring 4. When specifically set up, the carrier ring 4 can be a platinum ring, or a 316 stainless steel ring, or a ceramic ring with a gold layer on the surface, wherein the material of the ceramic ring can be aluminum trioxide or aluminum zirconate titanate.

As shown in Fig. 6, when the ultrasonic balloon catheter assembly is used, it is necessary to form an ultrasonic balloon catheter system together with an ultrasonic control generator 6 for controlling the working state of the ultrasonic generating element 3 and a power source 7 to work, wherein the ultrasonic generating element 3 is connected to the ultrasonic control generator 6 through the connecting wire 5 that goes out of the balloon 2.

When using the ultrasonic balloon catheter assembly, that is, when using the ultrasonic balloon catheter assembly to remove intravascular calcified plaques, follow the steps below:

(1) Send the balloon 2 through the catheter 1 to the preset position, that is, pass the catheter 1 through the blood vessel until the balloon 2 is delivered to the position where there are calcified plaques to be treated;

(2) Inject fluid into the catheter 1, so that the fluid enters the balloon 2, so that the balloon 2 is filled with fluid and then expands and contacts the blood vessel wall. The fluid introduced is usually normal saline;

(3) The ultrasonic control generator 6 works and controls the ultrasonic generating element 3 to emit ultrasonic waves, so that the ultrasonic waves directly act on the calcified plaques through the fluid and the balloon, so that the calcified plaques are stripped of blood vessels and fragmented and then discharged from the body with the blood circulation. To achieve the purpose of removing calcified plaques in blood vessels. Among them, the ultrasonic frequency emitted by the ultrasonic generating element 3 is controlled by the ultrasonic control generator 6 at 20KHz～2MHz, and the working voltage of the ultrasonic generating element 3 is 350～500V. The ultrasonic waves at work are within a safe range for the human body. It will cause damage to the human body and has good safety.

In summary, in the ultrasound balloon catheter assembly of the present invention, the catheter 1 attached with the balloon 2 is provided with an ultrasound generating element 3 capable of emitting ultrasound. When it is used to remove intravascular calcified plaques, only fluid is needed to make the balloon After the capsule 2 is filled, the ultrasonic generating element 3 is activated to enable it to emit ultrasonic waves and directly penetrate the fluid to directly act on the vascular calcified plaques, thereby achieving the purpose of removing the vascular calcified plaques. The permeability is good, the removal of calcified spots is more direct, and the safety is better.

The above-mentioned embodiments are only to illustrate the technical concept and characteristics of the present invention, and their purpose is to enable those familiar with the technology to understand the content of the present invention and implement it, and cannot limit the scope of protection of the present invention. All equivalent changes or modifications made by the substance shall be covered by the protection scope of the present invention.

Claims

An ultrasound balloon catheter assembly, comprising a catheter and an expandable balloon arranged on the catheter. The catheter passes through the balloon lumen in the axial direction and is used to pass into the inner lumen of the balloon. Into fluid, the periphery of the balloon and the catheter are sealed and arranged, characterized in that: the catheter assembly further includes an ultrasonic generating element capable of emitting ultrasonic waves, and the ultrasonic generating element is arranged on the catheter and located The inner cavity of the balloon.
The ultrasonic balloon catheter assembly according to claim 1, wherein the catheter assembly further comprises a connecting wire connected to the ultrasonic generating element, and the other end of the connecting wire passes out to the outside of the balloon .
The ultrasonic balloon catheter assembly of claim 1, wherein the ultrasonic generating elements are arranged in multiple groups at intervals along the length of the catheter.
The ultrasonic balloon catheter assembly of claim 1, wherein the ultrasonic generating element is an ultrasonic chip element capable of emitting ultrasonic waves.
The ultrasonic balloon catheter assembly according to any one of claims 1 to 4, wherein the ultrasonic generating element is fixedly arranged on the catheter through a carrier ring.
The ultrasound balloon catheter assembly of claim 5, wherein the carrier ring is fixedly sleeved on the catheter, and the carrier ring is provided with a supporting platform, and the ultrasonic generating element is fixedly provided On the supporting platform.
The ultrasound balloon catheter assembly according to claim 6, wherein the carrier ring is a platinum ring or a 316 stainless steel ring.
The ultrasonic balloon catheter assembly of claim 6, wherein the carrier ring is a ceramic ring with a gold layer on the surface.
The ultrasonic balloon catheter assembly of claim 8, wherein the material of the ceramic ring is aluminum trioxide or aluminum zirconate titanate.
The ultrasonic balloon catheter assembly according to claim 1, wherein the ultrasonic generating elements are arranged in multiple groups at intervals along the length of the catheter, and the ultrasonic generating elements are ultrasonic chip elements capable of emitting ultrasonic waves. , And each of the ultrasonic chip elements is fixedly arranged on the catheter via a carrier ring, the catheter assembly further includes a connecting wire connected to the ultrasonic generating element, and the other end of the connecting wire passes through To the outside of the balloon.
The ultrasound balloon catheter assembly of claim 10, wherein the carrier ring is fixedly sleeved on the catheter, and the carrier ring is provided with a supporting platform, and the ultrasonic generating element is fixedly provided On the supporting platform.
The ultrasound balloon catheter assembly of claim 10, wherein the carrier ring is a platinum ring.
An ultrasound balloon catheter system, characterized in that it comprises the ultrasound balloon catheter assembly according to any one of claims 1 to 12, and further comprises an ultrasound control generator for controlling the working state of the ultrasound generating element, and A power source, and the ultrasonic generating element is connected to the ultrasonic control generator through a connecting wire that passes out of the balloon.
A method of using an ultrasonic balloon catheter assembly, characterized in that: the ultrasonic balloon catheter assembly according to any one of claims 1 to 12 is used, and the method of use includes:

(1) Send the balloon to a preset position via the catheter;

(2) Inject fluid into the catheter and make the balloon inflated after being filled with the fluid;

(3) Control the ultrasonic generating element to emit ultrasonic waves.
The method of using the ultrasonic balloon catheter assembly according to claim 14, wherein the working frequency of the ultrasonic generating element is 20KHz-2MHz.
The method of using the ultrasonic balloon catheter assembly according to claim 14, wherein the working voltage of the ultrasonic generating element is 350-500V.