CN111973252A - Ultrasonic balloon catheter system and using method thereof - Google Patents

Abstract

The invention discloses an ultrasonic balloon catheter system and a method of using the same. In the ultrasonic balloon catheter system, the catheter component has a balloon catheter and a deformable recovery sleeve. During operation, the filling of the balloon catheter can be used. and generate ultrasonic waves to peel off the calcified plaque from the blood vessel wall, and use the recovery sleeve to deform to form a recovery filter that can recover the calcified plaque. Take it out of the blood vessel together, so that it is completely removed from the blood vessel, avoiding the risk of calcified plaque still remaining in the blood vessel with the blood flow. The ultrasonic balloon catheter system has a simple structure and is convenient to operate.

Description

Ultrasound balloon catheter system and method of using the same

technical field

The invention relates to an ultrasonic balloon catheter system capable of removing vascular occlusion plaque and a method of using the same.

Background technique

Vascular calcification refers to the deposition of calcium salts in the walls of arterial and venous vessels, that is, calcified plaques on the inner walls of arteries and veins, which seriously threatens the health of patients. In recent years, for intravascular calcium deposition, a catheter with a balloon is inserted into the blood vessel, usually by means of minor surgery, and the balloon is inflated when the balloon reaches the calcium deposit, and the balloon is placed in the balloon using The electrodes work to release high-voltage pulses, creating a shock wave that propagates through the fluid and strikes the balloon wall and calcified area to disrupt calcium deposits with the repeated pulses.

In the prior art, the method of generating shock waves in the human body is mostly used to remove the calcified plaques in the human blood vessels, which requires the generation of high-voltage pulses in the human body, and the generated pulses promote the filling of the liquid in the balloon to generate air bubbles. , so that the bubble acts on the balloon wall when it ruptures, and then acts 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 damage to the blood vessel to a certain extent. Not used clinically.

In order to safely and effectively remove calcified plaques in blood vessels, the Chinese Patent Publication No. CN 109953799 A discloses an ultrasonic balloon catheter assembly, a catheter system and a method of use, wherein the removal is performed by using ultrasonic waves in the human body Calcified plaques in human blood vessels. However, this solution only solves the problem of removing calcified plaques, but the removed plaques still remain in the blood vessels. If they cannot be removed from the human blood vessels, they will flow to other parts of the body with blood, such as This poses a great threat to the health of the patients after surgery.

SUMMARY OF THE INVENTION

An object of the present invention is to provide an ultrasound balloon catheter system capable of removing vascular occlusive plaque, thereby removing the calcified plaque occluded in the blood vessel after removing it.

In order to achieve the above object, the technical scheme adopted in the present invention is: an ultrasonic balloon catheter system, comprising a catheter assembly and an ultrasonic wave generating element capable of emitting ultrasonic waves, the catheter assembly includes a balloon catheter, and the balloon catheter includes an inner catheter and an inflatable balloon disposed on the inner catheter, the inner catheter penetrates the inner cavity of the balloon in the axial direction and can pass fluid into the inner cavity of the balloon, and the inner cavity of the balloon is A sealed connection is made between the peripheral part and the inner catheter, the ultrasonic generating element is arranged on the inner catheter and is located in the inner cavity of the balloon, and the catheter assembly further comprises:

a first catheter, which can be relatively slidably sheathed outside the balloon catheter;

a second conduit, which can be relatively slidably sheathed outside the first conduit;

The filter sleeve has a mesh-shaped peripheral wall, the filter sleeve can be relatively slidably sleeved outside the first conduit, and the front end of the filter sleeve is fixedly connected to the front of the first conduit. the rear end of the filter sleeve is fixedly connected to the front part of the second conduit;

The protective sleeve is sleeved outside the second conduit and the filter sleeve in a relatively sliding manner.

Preferably, the catheter system further comprises a first handle fixed at the rear of the first catheter and a second handle fixed at the rear of the second catheter, between the first handle and the second handle A lock is also provided that can relatively separate or relatively fix the two.

Preferably, the ultrasonic balloon catheter system further comprises an ultrasonic control generator for controlling the working state of the ultrasonic generating element, and the ultrasonic generating element communicates with the ultrasonic control device through a connecting wire extending out of the balloon. Generator connection.

Preferably, the front end of the filter sleeve is fixedly connected to the first connection position of the first conduit, and the rear end of the filter sleeve is fixedly connected to the second connection position of the second conduit, The filter sleeve has a retracted state and an open state. When the filter sleeve is in the retracted state, the distance between the first connection position and the second connection position is the same as that of the filter sleeve. The lengths of the pipes are the same, and the filter sleeve is sleeved outside the first conduit in a cylindrical shape; when the filter sleeve is in an open state, the first connection position is connected to the second connection The distance between the positions is smaller than the length of the filter screen sleeve, and the filter screen sleeve is sleeved outside the first conduit in a truncated cone shape.

Further, when the filter sleeve is in the open state, the filter sleeve has a collection working position located outside the protective sleeve, and a recovery working mode accommodated in the protective sleeve.

Further, when the filter screen sleeve is in an open state, the filter screen sleeve is squeezed and deformed to form the frustum-shaped recovery filter screen capable of collecting vascular plaque, and the recovery filter screen has a front end. Large area and small rear end area frustum shape.

Further, the recovery filter screen includes a first tapered portion and a second tapered portion connected to the front end, and the first tapered portion extends forward and outwardly inclined from the second connection position, so The second tapered portion extends forward and outwardly obliquely from the first connection position, and the second tapered portion is located in the first tapered portion.

Further, the recovery filter screen is formed when the distance between the first connection position and the second connection position is less than half the length of the screen sleeve.

Preferably, the filter sleeve is a cylindrical shape formed by weaving a flexible belt made of metal wire or high-strength PP material.

Another object of the present invention is to provide a method of using the above-mentioned ultrasonic balloon catheter system.

To achieve the above object, the technical scheme adopted in the present invention is:

A method of using an ultrasonic balloon catheter system, using the above-mentioned ultrasonic balloon catheter system, the using method comprises the following steps:

(1) Keep the balloon in the first conduit, and the filter sleeve is sleeved outside the first conduit in an axially elongated manner, and connect the first conduit with the second conduit and the The protective sleeve is synchronously penetrated from the back to the front to the initial preset position;

(2) Slide the first conduit, the filter sleeve and the second conduit forward synchronously to pass them out of the protective sleeve to a first preset position;

(3) passing the balloon forward from the first catheter to a second preset position through the inner catheter;

(4) Pull the first conduit backward to make it slide backward relative to the second conduit, so that the filter screen sleeve is squeezed and deformed in the axial direction to expand to form a frustum-shaped recovery screen;

(5) injecting fluid into the inner catheter and causing the balloon to be filled with the liquid and then inflated, and then the ultrasonic generating element works to generate ultrasonic waves for a preset duration;

(6) Open the liquid flow input port of the inner catheter, and pull the inner catheter backward, so that the balloon moves backwards and gradually releases the liquid inside it during the backward movement, until the balloon moves backwards. is received in the first conduit;

(7) Pull the first conduit and the second conduit backward synchronously, so that the recovery filter screen is squeezed and accommodated in the protective sleeve,

Wherein, the step (4) is performed before, or after, or synchronously with the step (5).

Due to the application of the above-mentioned technical solutions, the present invention has the following advantages compared with the prior art: the ultrasonic balloon catheter system of the present invention and its using method can remove the calcified plaques blocked in the blood vessel, and also can break the calcified plaques. Take it out of the blood vessel together, so that it is completely removed from the blood vessel, avoiding the risk of calcified plaque still remaining in the blood vessel with the blood flow. The ultrasonic balloon catheter system has a simple structure and is convenient to operate.

Description of drawings

1 is a schematic diagram of the overall structure of the ultrasonic balloon catheter system of the present invention;

2 is a side view of the ultrasonic balloon catheter system of the present invention;

Accompanying drawing 3 is along P-P in accompanying drawing 2 sectional structure schematic diagram;

4 is a schematic longitudinal section of the initial state of the ultrasonic balloon catheter system of the present invention;

Accompanying drawing 5 is the enlarged schematic diagram of A part in FIG. 4;

6 is a schematic longitudinal section of the ultrasonic balloon catheter system of the present invention, when the first catheter and the second catheter are extended to the initial preset position;

Accompanying drawing 7 is the enlarged schematic diagram of B part in FIG. 6;

8 is a schematic diagram of a longitudinal section after the filter sleeve is converted into an open state in the ultrasonic balloon catheter system of the present invention;

Accompanying drawing 9 is the enlarged schematic diagram of C part in FIG. 8;

Fig. 10 is a longitudinal sectional view when the balloon is extended forward to the second preset position on the basis of Fig. 8;

Accompanying drawing 11 is the enlarged schematic diagram of D part in FIG. 10;

Accompanying drawing 12 is on the basis of FIG. 10 , the longitudinal sectional schematic diagram of balloon when it is inflated after injecting liquid;

Accompanying drawing 13 is the enlarged schematic diagram of E part in FIG. 12;

Fig. 14 is a schematic longitudinal sectional view in the process of the balloon gradually moving backwards and discharging liquid on the basis of Fig. 12;

Accompanying drawing 15 is the enlarged schematic diagram of F part in FIG. 14;

Among them: 1. Balloon catheter; 11. Inner catheter; 12. Balloon; 13. Liquid injection head; 2. Filter sleeve; 21. First tapered part; 22. Second tapered part; 1. catheter; 4. second catheter; 5. protective sleeve; 6. ultrasonic generating element; 7. operating handle; 70, handle seat; 71, first handle; 72, second handle; 73, limit groove; 8, Ultrasonic control generator; 9, connecting line; 10, blood vessel; 20, calcified plaque.

Detailed ways

The technical solutions of the present invention will be further elaborated below with reference to the accompanying drawings and specific embodiments.

The following description about the front-to-back direction is defined with reference to the penetration direction of the catheter assembly into the blood vessel 10 when the catheter system is in use.

1 to 3 , an ultrasonic balloon catheter system includes a catheter assembly, an ultrasonic generating element 6 capable of emitting ultrasonic waves, and an ultrasonic control generator 8 for controlling the operation of the ultrasonic generating element 6 .

The catheter assembly includes a balloon catheter 1, the balloon catheter 1 including an inner catheter 11 and an inflatable balloon 12 disposed at the front of the inner catheter 11, the inner catheter 11 axially passes through the lumen of the balloon 12 and can be directed toward the inner catheter 12. Fluid is introduced into the inner cavity of the balloon 12, and the circumference of the balloon 12 is sealed with the inner catheter 11. The inner catheter 11 located in the inner cavity of the balloon 12 has a plurality of liquid flow holes, and the liquid flow holes communicate with each other. The inner cavity of the balloon 12 and the inner cavity of the inner catheter 11 are provided with a liquid injection head 13 at the rear end of the inner catheter 11. By injecting liquid into the liquid injection head 13, the liquid enters the balloon 12 through the liquid flow hole of the inner catheter 11. The inner cavity of the balloon 12 is inflated, or the liquid flows out of the inner catheter 11 from the liquid flow hole in the balloon 12 and the balloon 12 is deflated. The ultrasonic generating element 6 is arranged on the inner catheter 11 and is located in the inner cavity of the balloon 12 .

The catheter assembly also includes:

a first catheter 3, the first catheter 3 can be sleeved outside the balloon catheter 1 in a relatively sliding manner;

the second conduit 4, the second conduit 4 can be sleeved outside the first conduit 3 in a relatively sliding manner;

The filter sleeve 2 is cylindrical when it is not extruded, and its peripheral wall is a mesh. It can be formed by weaving a flexible belt made of high-strength PP material, or by using a metal wire, preferably a titanium alloy. Silk. The filter sleeve 2 can be relatively slidably sleeved outside the first conduit 3, the front end of the filter sleeve 2 is fixedly connected to the front of the first conduit 3, and its connection position is the first connection position; The rear end portion of the sleeve 2 is fixedly connected to the front portion of the second conduit 4, and its connection position is the second connection position;

The protective sleeve 5 is sleeved outside the second conduit 4 and the filter sleeve 2 in a relatively sliding manner.

Wherein, the filter sleeve 2 has a retracted state and an open state according to its axially squeezed state. When the filter sleeve 2 is in the retracted state, the distance between the first connection position and the second connection position is the same as The length of the filter sleeve 2 is the same, and the filter sleeve 2 is sleeved outside the first conduit 3 in a cylindrical shape; when the filter sleeve 2 is in the open state, the difference between the first connection position and the second connection position is The distance between them is smaller than the length of the filter sleeve 2 , and the filter sleeve 2 is extruded and deformed along the axial direction to be sleeved outside the first conduit 2 in a frustum shape.

In specific use, when the filter sleeve 2 is in the open state, the filter sleeve 2 is squeezed and deformed to form a truncated cone-shaped recovery filter that can collect the vascular plaque 20, and the recovery filter has a front end. The calcified plaque located in front of the filter sleeve 2 can enter into the recovery filter and be collected by the recovery filter when moving backward.

8 to 15 , the recovery filter screen formed by the filter sleeve 2 in the open state includes a first tapered portion 21 and a second tapered portion 22 whose front ends are connected. The first tapered portion 21 extends obliquely forward and outward from the second connecting position, the second tapered portion 22 extends forward and obliquely outward from the first connecting position, and the second tapered portion 22 is located in the first tapered portion 21 Medium. The recovery filter screen is formed when the distance between the first connection position and the second connection position is less than half the length of the filter screen sleeve 2 . The filter sleeve 2 in the open state also has a collection working state outside the protective sleeve 5 and a recovery working mode accommodated in the protective sleeve 5 .

Referring to the drawings, the catheter system further includes an operating handle 7, the operating handle 7 includes a first handle 71 fixed at the rear of the first catheter 3, and a second handle 72 fixed at the rear of the second catheter 4, Between the first handle 71 and the second handle 72 is further provided a lock (not shown in the figure) that can relatively separate or relatively fix the two. When the first handle 71 and the second handle 72 are fixed to each other by the lock, the first pipe 3, the second pipe 4 and the filter sleeve 2 can be driven to move forward and backward synchronously; when the lock is released, the first handle 71 When the second handle 72 is separated from each other, the user can individually drive the first conduit 3 to move backward, so that the filter sleeve 2 is squeezed and deformed to switch from the retracted state to the open state.

The operating handle 7 also includes a handle seat 70 fixed on the rear of the protective sleeve 5 , the handle seat 70 is provided with a limit groove 73 extending in the front-rear direction, and the first handle 71 and the second handle 72 are relatively slidable. In the limiting groove 73, the sliding position of the first conduit 3 and the second conduit 4 can be limited in actual operation, and at the same time, when the first handle 71 and/or the second handle 72 are fixed relative to the handle seat 70, It is also possible to ensure that the protective sleeve 5 slides synchronously with the first conduit 3 and/or the second conduit 4 .

The method of using the ultrasonic balloon catheter system of the present embodiment will be described below in conjunction with the accompanying drawings:

Referring to FIGS. 3 to 5 , first keep the balloon 12 in an uninflated state and located in the first catheter 3 , and the filter sleeve 2 is in a retracted state, and the filter sleeve 2 is axially extended and sleeved Outside the first catheter 3, the second catheter 4 and the filter sleeve 2 are both located in the protective sleeve 5, and the front end of the catheter assembly in this state is penetrated forward into the blood vessel 10 to an initial preset position. The location is set behind the vascular occlusive plaque 20 in the blood vessel 10 .

Referring to Figure 6 and Figure 7, keep the protective sleeve 5 still, drive the first conduit 3, the second conduit 4 and the filter sleeve 2 to slide forward synchronously, so that they pass out of the protective sleeve 5 to the outside of the protective sleeve 5. A first preset position, the first preset position is in front of the above-mentioned initial preset position, and is located behind the blood vessel occlusion plaque 20 in the blood vessel 10 .

8 and 9, keep the second conduit 4 still, and pull the first conduit 3 backward to make it slide backward relative to the second conduit 4, so that the filter sleeve 2 is squeezed and stretched in the axial direction. A frustum-shaped recovery filter screen is formed, and the outer periphery of the front end of the recovery filter screen should be in contact with the inner wall of the blood vessel 10 or have a small gap.

Referring to FIGS. 10 and 11 , the balloon 12 is threaded forward from the first catheter 3 to the second preset position through the inner catheter 11 . At this time, the balloon 12 is located outside the lumen of the first catheter 3 and corresponds to At the site of the blocked calcified plaque 20 in the blood vessel.

12 and 13, the liquid is injected from the liquid injection head 13, so that the liquid enters the lumen of the balloon 12 through the inner catheter 11 to inflate the balloon 12, and when the balloon 12 is inflated, its periphery contacts the calcified plaque block 20, and then activate the ultrasonic generating element 6 to generate ultrasonic waves for a predetermined period of time, and the ultrasonic waves act on the calcified plate 20 to break the calcified plaques 20 and separate them from the blood vessel wall.

14 and 15 , open the liquid flow input port of the inner catheter 11, that is, keep the opening of the liquid injection head 13 at the rear end open, and then pull the inner catheter 11 backward, so that the balloon 12 moves backward, and During the backward movement, the balloon 12 is squeezed so that the liquid in its lumen is expelled from the inner catheter 11, the rear part of the balloon 12 is gradually contracted, and the front part of the balloon 12 is still kept tight and tight. Filled state, in this way, when the balloon 12 moves backwards, it will gradually push the broken calcified plate 20 left in the blood vessel backward, and make it move toward the recovery filter (that is, the filter sleeve 2 in the open state) The calcification plate 20 is completely driven into the recovery filter screen until the balloon 12 is accommodated in the first conduit 3 , or is directly pulled back from the first conduit 3 .

Finally, not shown, pull the first conduit 3 and the second conduit 4 backwards synchronously, so that the recovery filter screen on which the calcified slabs 20 are collected is squeezed and accommodated in the protective sleeve 5 . At this time, the first catheter 3 , the second catheter 4 and the protective sleeve 5 can be driven to move backward synchronously, so as to be taken out from the blood vessel 10 .

In this way, while removing the calcified plaque 20 blocked on the peripheral wall of the blood vessel 10, the removed calcified plaque 20 is also removed from the blood vessel 10, so as to avoid the calcified plaque 20 still remaining in the blood vessel 10 and caused by the flow of blood risks of.

The above-mentioned embodiments are only to illustrate the technical concept and characteristics of the present invention, and their purpose is to enable those who are familiar with the art to understand the content of the present invention and implement it, and cannot limit the scope of protection of the present invention with this, all according to the spirit of the present invention Substantially equivalent changes or modifications should be included within the protection scope of the present invention.

Claims (10)

1. An ultrasonic balloon catheter system, comprising a catheter assembly and an ultrasonic wave generating element capable of emitting ultrasonic waves, wherein the catheter assembly comprises a balloon catheter, the balloon catheter comprises an inner catheter and a balloon which is arranged on the inner catheter and can be inflated, the inner catheter axially penetrates through a balloon inner cavity and can feed fluid into the balloon inner cavity, the periphery of the balloon is in sealed connection with the inner catheter, and the ultrasonic wave generating element is arranged in the balloon inner cavity, and the ultrasonic wave generating element is characterized in that: the catheter assembly further comprises:

the first catheter is sleeved outside the balloon catheter in a relatively sliding manner;

the second conduit is sleeved outside the first conduit in a relatively sliding manner;

the peripheral wall of the filter screen sleeve is net-shaped, the filter screen sleeve can be sleeved outside the first guide pipe in a relatively sliding manner, the front end part of the filter screen sleeve is fixedly connected to the front part of the first guide pipe, and the rear end part of the filter screen sleeve is fixedly connected to the front part of the second guide pipe;

and the protective sleeve is sleeved outside the second conduit and the filter screen sleeve in a relatively sliding manner.

2. The ultrasonic balloon catheter system of claim 1, wherein: the catheter system further comprises a first handle fixedly arranged at the rear part of the first catheter and a second handle fixedly arranged at the rear part of the second catheter, and a lock catch capable of relatively separating or relatively fixing the first handle and the second handle is further arranged between the first handle and the second handle.

3. The ultrasonic balloon catheter system of claim 1, wherein: the ultrasonic balloon catheter system also comprises an ultrasonic control generator for controlling the working state of the ultrasonic generating element, and the ultrasonic generating element is connected with the ultrasonic control generator through a connecting wire penetrating out of the balloon.

4. The ultrasonic balloon catheter system of claim 1, wherein: the front end part of the filter screen sleeve is fixedly connected to a first connecting position of the first conduit, the rear end part of the filter screen sleeve is fixedly connected to a second connecting position of the second conduit, the filter screen sleeve has a folding state and an opening state, when the filter screen sleeve is in the folding state, the distance between the first connecting position and the second connecting position is the same as the length of the filter screen sleeve, and the filter screen sleeve is sleeved outside the first conduit in a cylindrical shape; when the filter screen sleeve pipe is in an open state, the distance between the first connecting position and the second connecting position is smaller than the length of the filter screen sleeve pipe, and the filter screen sleeve pipe is sleeved outside the first conduit pipe in a frustum shape.

5. The ultrasonic balloon catheter system of claim 4, wherein: when the screen sleeve is in the open state, the screen sleeve has a collection operating position located outside the protective sleeve and a recovery operating mode housed in the protective sleeve.

6. The ultrasonic balloon catheter system of claim 4, wherein: when the filter screen sleeve pipe is in the open mode, the filter screen sleeve pipe is extruded and deformed and forms the frustum form just can collect the recovery filter screen of blood vessel plaque, it is the frustum form that the front end area is big and the rear end area is little to retrieve the filter screen.

7. The ultrasonic balloon catheter system of claim 6, wherein: the recovery filter screen comprises a first conical part and a second conical part, wherein the first conical part and the second conical part are connected at the front end part, the first conical part extends forwards and outwards in an inclined mode from the second connecting position, the second conical part extends forwards and outwards in an inclined mode from the first connecting position, and the second conical part is located in the first conical part.

8. The ultrasonic balloon catheter system of claim 6, wherein: the recovery screen is formed when the distance between the first connection position and the second connection position is less than half the length of the screen sleeve.

9. The ultrasonic balloon catheter system of claim 1, wherein: the filter screen sleeve is formed by weaving a flexible belt made of metal wires or high-strength PP materials.

10. A method of using an ultrasound balloon catheter system, comprising: the ultrasonic balloon catheter system according to any one of claims 1-9, wherein the method of use comprises the steps of:

(1) keeping the balloon in the first catheter, sleeving the filter screen sleeve outside the first catheter in an axially extending manner, and synchronously penetrating the first catheter, the second catheter and the protective sleeve from back to front to an initial preset position;

(2) synchronously sliding the first guide pipe, the filter screen sleeve pipe and the second guide pipe forwards to enable the first guide pipe, the filter screen sleeve pipe and the second guide pipe to penetrate out of the protective sleeve pipe to a first preset position;

(3) passing the balloon forwardly out of the first catheter via the inner catheter to a second preset position;

(4) pulling the first guide pipe backwards to enable the first guide pipe to slide backwards relative to the second guide pipe, so that the filter screen sleeve is extruded and deformed in the axial direction to expand to form a frustum-shaped recovery filter screen;

(5) introducing fluid into the inner catheter, inflating the balloon after the balloon is filled with the liquid, and then operating the ultrasonic wave generating element to generate ultrasonic waves for a preset time;

(6) opening the liquid flow input port of the inner catheter, and pulling the inner catheter backwards, so that the balloon moves backwards and gradually releases liquid in the balloon in the backward movement process until the balloon is accommodated in the first catheter;

(7) simultaneously pulling back the first and second conduits so that the recovery screen is squeezed and housed into the protective sleeve,

wherein, the step (4) is performed before, after or synchronously with the step (5).

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