Ultrasonic balloon catheter system and method of use thereof

Abstract

The invention discloses an ultrasonic balloon catheter system and a method for using the same. In the ultrasonic balloon catheter system, a catheter assembly includes a balloon catheter and a deformable recovery sleeve. During operation, the balloon catheter can be filled and ultrasonic waves can be generated to peel off the calcified plaque from the blood vessel wall. The recovery sleeve is deformed to form a recovery filter capable of recovering the calcified plaque. In this way, after removing the calcified plaque blocking the blood vessel, the broken calcified plaque can also be taken out of the blood vessel together, so that it can be completely removed from the blood vessel, avoiding the risk of the calcified plaque remaining in the blood vessel and flowing with the blood. The ultrasonic balloon catheter system has a simple structure and is easy to operate.

Description

Technical Field

[0001] The invention relates to an ultrasonic balloon catheter system capable of clearing blood vessel obstructing plaques and a use method thereof. Background Art

[0002] Vascular calcification refers to the deposition of calcium salts in the walls of arteries and veins, that is, calcified plaques on the inner walls of arteries and veins, which seriously threaten the health of patients. In recent years, calcium deposition in blood vessels is usually treated by a small operation, in which a catheter equipped with a balloon is inserted into the blood vessel, and the balloon is inflated when it reaches the calcium deposition site, and the electrodes arranged in the balloon are used to release high-voltage pulses to form shock waves, which propagate through the fluid and hit the balloon wall and the calcified area, so as to destroy the calcium deposition by the repeated pulses.

[0003] In the previous technology, most of them use the method of generating shock waves in the human body to remove calcified plaques in human blood vessels. This requires generating high-voltage pulses in the human body, and using the generated pulses to cause bubbles to be generated in the liquid filled in the balloon, so that when the bubbles burst, they act on the balloon wall and then act on the calcified plaques. However, the thickness of the blood vessels at different locations 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 pulses to eliminate calcified plaques in the human body has not been applied clinically.

[0004] In order to safely and effectively remove calcified plaques in blood vessels, a Chinese patent with publication number CN 109953799 A discloses an ultrasonic balloon catheter assembly, a catheter system and a method of use, wherein calcified plaques in human blood vessels are removed by generating ultrasonic waves in the human body. 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 circulate with the blood to other parts of the body, such as the heart, which poses a great threat to the health of the patient after surgery. Summary of the invention

[0005] The object of the present invention is to provide an ultrasonic balloon catheter system capable of clearing blood vessel obstructing plaques, so as to remove the obstructing calcified plaques from the blood vessel after removing the plaques.

[0006] To achieve the above-mentioned purpose, the technical solution adopted by the present invention is: an ultrasonic balloon catheter system, comprising a catheter assembly and an ultrasonic generating element capable of emitting ultrasonic waves, the catheter assembly comprising a balloon catheter, the balloon catheter comprising an inner catheter and a balloon arranged on the inner catheter and capable of expanding, the inner catheter axially passes through the inner cavity of the balloon and can pass fluid into the inner cavity of the balloon, the periphery of the balloon is sealed and connected to 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 also includes:

[0007] A first catheter, which can be relatively slidably sleeved outside the balloon catheter;

[0008] A second catheter, which can be relatively slidably sleeved outside the first catheter;

[0009] A filter sleeve, whose peripheral wall is in a mesh shape, the filter sleeve can be relatively slidably sleeved outside the first conduit, the front end of the filter sleeve is fixedly connected to the front part of the first conduit, and the rear end of the filter sleeve is fixedly connected to the front part of the second conduit;

[0010] The protection sleeve can be relatively slidably sleeved outside the second conduit and the filter sleeve.

[0011] Preferably, the catheter system further comprises a first handle fixedly mounted on the rear of the first catheter and a second handle fixedly mounted on the rear of the second catheter, and a lock capable of relatively separating or relatively fixing the first handle and the second handle is further provided between the first handle and the second handle.

[0012] 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 is connected to the ultrasonic control generator via a connecting line extending to the outside of the balloon.

[0013] Preferably, the front end portion of the filter sleeve is fixedly connected to the first connection position of the first conduit, and the rear end portion 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 the length of the filter sleeve, and the filter sleeve is cylindrically sleeved outside the first conduit; when the filter sleeve is in the open state, the distance between the first connection position and the second connection position is smaller than the length of the filter sleeve, and the filter sleeve is frustoconical sleeved outside the first conduit.

[0014] Furthermore, 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.

[0015] Furthermore, when the filter sleeve is in an open state, the filter sleeve is squeezed and deformed to form the frustum-shaped recovery filter capable of collecting vascular plaques. The recovery filter is in a frustum-shaped shape with a large front end area and a small rear end area.

[0016] Furthermore, the recovery filter includes a first conical portion and a second conical portion connected at the front end, the first conical portion extends forward and outwardly from the second connection position, the second conical portion extends forward and outwardly from the first connection position, and the second conical portion is located in the first conical portion.

[0017] Furthermore, the recovery filter is formed when the distance between the first connection position and the second connection position is less than half the length of the filter sleeve.

[0018] Preferably, the filter sleeve is a cylindrical shape formed by weaving a flexible belt made of metal wire or high-strength PP material.

[0019] Another object of the present invention is to provide a method for using the ultrasonic balloon catheter system.

[0020] In order to achieve the above object, the technical solution adopted by the present invention is:

[0021] A method for using an ultrasonic balloon catheter system, using the ultrasonic balloon catheter system as described above, the method for using the ultrasonic balloon catheter system comprises the following steps:

[0022] (1) The balloon is kept in the first catheter, and the filter sleeve is axially extended and sleeved outside the first catheter, and the first catheter, the second catheter and the protective sleeve are synchronously inserted from back to front to an initial preset position;

[0023] (2) synchronously sliding the first conduit, the filter sleeve, and the second conduit forward so that they pass through the protection sleeve to a first preset position;

[0024] (3) passing the balloon forward from the first catheter to a second preset position via the inner catheter;

[0025] (4) Pulling the first conduit backward to make it slide backward relative to the second conduit, so that the filter sleeve is squeezed and deformed along the axial direction and opens to form a frustum-shaped recovery filter;

[0026] (5) introducing fluid into the inner catheter and causing the balloon to expand after being filled with the fluid, and then the ultrasonic wave generating element operates to generate ultrasonic waves for a preset duration;

[0027] (6) opening the liquid flow input port of the inner catheter and pulling the inner catheter backward, so that the balloon moves backward and gradually releases the liquid inside it during the backward movement until the balloon is accommodated in the first catheter;

[0028] (7) Synchronously pulling the first conduit and the second conduit backward so that the recovery filter is squeezed and accommodated in the protective sleeve,

[0029] Wherein, step (4) is performed before, after, or synchronously with step (5).

[0030] Due to the application of the above technical solution, the present invention has the following advantages compared with the prior art: the ultrasonic balloon catheter system and the use method of the present invention can remove the calcified plaques blocking the blood vessel and also remove the broken calcified plaques from the blood vessel, so that the calcified plaques can be completely removed from the blood vessel, avoiding the risk of calcified plaques remaining in the blood vessel and flowing with the blood. The ultrasonic balloon catheter system has a simple structure and is easy to operate. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Attached Figure 1 It is a schematic diagram of the overall structure of the ultrasonic balloon catheter system of the present invention;

[0032] Attached Figure 2 is a side view of the ultrasonic balloon catheter system of the present invention;

[0033] Attached Figure 3 For the attachment Figure 2 Schematic diagram of the cross-sectional structure in the middle PP direction;

[0034] Attached Figure 4 It is a longitudinal cross-sectional schematic diagram of the initial state of the ultrasonic balloon catheter system of the present invention;

[0035] Attached Figure 5 for Figure 4 A magnified schematic diagram of the middle part;

[0036] Attached Figure 6 It is a longitudinal cross-sectional schematic diagram of the ultrasonic balloon catheter system of the present invention when the first catheter and the second catheter are extended to the initial preset positions;

[0037] Attached Figure 7 for Figure 6 The enlarged schematic diagram of the middle B part;

[0038] Attached Figure 8It is a longitudinal cross-sectional schematic diagram of the filter sleeve after it is converted into an open state in the ultrasonic balloon catheter system of the present invention;

[0039] Attached Fig. 9 for Figure 8 Enlarged schematic diagram of middle C part;

[0040] Attached Fig.10 For Figure 8 A longitudinal cross-sectional schematic diagram when the balloon is extended forward to a second preset position based on the present invention;

[0041] Attached Fig.11 for Fig.10 The enlarged schematic diagram of the middle D part;

[0042] Attached Fig.12 For Fig.10 Based on the figure, a longitudinal section diagram of the balloon when it is expanded after the liquid is injected into it;

[0043] Attached Fig.13 for Fig.12 The enlarged schematic diagram of the middle E part;

[0044] Attached Fig.14 For Fig.12 Based on the longitudinal section diagram of the balloon gradually moving backward and discharging liquid;

[0045] Attached Fig.15 for Fig.14 Enlarged schematic diagram of the middle F part;

[0046] Among them: 1. Balloon catheter; 11. Inner catheter; 12. Balloon; 13. Injection head; 2. Filter sleeve; 21. First conical portion; 22. Second conical portion; 3. First catheter; 4. Second catheter; 5. Protective sleeve; 6. Ultrasonic generating element; 7. Operating handle; 70. Handle seat; 71. First handle; 72. Second handle; 73. Limiting groove; 8. Ultrasonic control generator; 9. Connecting line; 10. Blood vessel; 20. Calcification plaque. DETAILED DESCRIPTION

[0047] The technical solution of the present invention is further described below in conjunction with the accompanying drawings and specific embodiments.

[0048] The following descriptions of the front and back directions are all defined with reference to the direction in which the catheter assembly penetrates into the blood vessel 10 when the catheter system is in use, wherein the end that first enters the blood vessel 10 is the front, and the opposite end is the back.

[0049] See also Figures 1 to 3 As shown, an ultrasonic balloon catheter system includes a catheter assembly and 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.

[0050] The catheter assembly includes a balloon catheter 1, which includes an inner catheter 11 and a balloon 12 that is arranged at the front of the inner catheter 11 and can expand. The inner catheter 11 passes through the inner cavity of the balloon 12 axially and can pass fluid into the inner cavity of the balloon 12. The periphery of the balloon 12 is sealedly connected to the inner catheter 11. The inner catheter 11 located in the inner cavity of the balloon 12 has a plurality of liquid flow holes, which connect the inner cavity of the balloon 12 with the inner cavity of the inner catheter 11. The rear end of the inner catheter 11 is provided with an injection head 13. By injecting liquid into the injection head 13, the liquid enters the inner cavity of the balloon 12 through the liquid flow holes of the inner catheter 11, thereby expanding the balloon 12, or the liquid flows out of the inner catheter 11 from the liquid flow holes in the balloon 12, thereby shrinking the balloon 12. The ultrasonic generating element 6 is arranged on the inner catheter 11 and is located in the inner cavity of the balloon 12 . One end of the connecting line 9 is connected to the ultrasonic generating element 6 , and the other end passes through the outside of the balloon 12 and is connected to the ultrasonic control generator 8 .

[0051] The catheter assembly also includes:

[0052] A first catheter 3, which can be relatively slidably sleeved outside the balloon catheter 1;

[0053] A second conduit 4, which can be relatively slidably sleeved outside the first conduit 3;

[0054] The filter sleeve 2 is cylindrical when not squeezed, and its peripheral wall is mesh-shaped. It can be woven from a flexible belt made of high-strength PP material, or woven from metal wires, preferably titanium alloy wires. The filter sleeve 2 can be relatively slidably sleeved outside the first conduit 3, and 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 of the filter sleeve 2 is fixedly connected to the front of the second conduit 4, and its connection position is the second connection position;

[0055] The protective sleeve 5 is relatively slidably sleeved outside the second conduit 4 and the filter sleeve 2 .

[0056] Among them, the filter sleeve 2 has a retracted state and an open state according to its axial extrusion condition. 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, and the filter sleeve 2 is cylindrically sleeved outside the first conduit 3; when the filter sleeve 2 is in the open state, the distance between the first connection position and the second connection position is smaller than the length of the filter sleeve 2, and the filter sleeve 2 is squeezed and deformed along the axial direction and is sleeved outside the first conduit 2 in a frustum shape.

[0057] During specific use, when the filter sleeve 2 is in an open state, the filter sleeve 2 is squeezed and deformed to form a cone-shaped recovery filter that can collect vascular plaques 20, and the recovery filter is in the shape of a cone with a large front end area and a small rear end area. The calcified plaque located in front of the filter sleeve 2 can enter the recovery filter when moving backward and be collected by it.

[0058] See Figures 8 to 15 As shown, the recovery filter formed by the filter sleeve 2 in the open state includes a first tapered portion 21 and a second tapered portion 22 connected at the front end, the first tapered portion 21 extends forward and outward from the second connection position, the second tapered portion 22 extends forward and outward from the first connection position, and the second tapered portion 22 is located in the first tapered portion 21. The recovery filter is formed when the spacing between the first connection position and the second connection position is less than half the length of the filter sleeve 2. The filter sleeve 2 in the open state also has a collection working state located outside the protective sleeve 5 and a recovery working mode accommodated in the protective sleeve 5.

[0059] As shown in the drawings, the catheter system also includes an operating handle 7, which includes a first handle 71 fixed to the rear of the first catheter 3 and a second handle 72 fixed to the rear of the second catheter 4. A lock (not shown in the figure) is provided between the first handle 71 and the second handle 72 to 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 catheter 3, the second catheter 4 and the filter sleeve 2 can be driven and ensured to move forward and backward synchronously; when the lock is unlocked and the first handle 71 and the second handle 72 are separated from each other, the user can drive the first catheter 3 to move backward alone, so that the filter sleeve 2 is squeezed and deformed and converted from the retracted state to the open state.

[0060] The operating handle 7 also includes a handle seat 70 fixedly arranged at the rear of the protective sleeve 5, and the handle seat 70 is provided with a limiting groove 73 extending in the front-to-back direction. The first handle 71 and the second handle 72 can be relatively slidably arranged in the limiting groove 73, so that the sliding position of the first catheter 3 and the second catheter 4 can be limited in actual operation. At the same time, when the first handle 71 and / or the second handle 72 is fixed relative to the handle seat 70, it can also ensure that the protective sleeve 5 and the first catheter 3 and / or the second catheter 4 slide synchronously.

[0061] The following is a description of the method for using the ultrasonic balloon catheter system of this embodiment in conjunction with the accompanying drawings:

[0062] See also Figures 3 to 5As shown, the balloon 12 is first kept in an unfilled state and located in the first catheter 3, and the filter sleeve 2 is in a retracted state. 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. The front end of the catheter assembly in this state is inserted forward into the blood vessel 10 to an initial preset position, which is located behind the vascular occlusive plaque 20 in the blood vessel 10.

[0063] See also Figure 6 , Figure 7 As shown, the protective sleeve 5 is kept stationary, and the first catheter 3, the second catheter 4 and the filter sleeve 2 are driven to slide forward synchronously so that they pass out of the protective sleeve 5 to a first preset position, which is in front of the above-mentioned initial preset position and is located behind the vascular occluding plaque 20 in the blood vessel 10.

[0064] See also Figure 8 , Fig. 9 As shown, the second catheter 4 is kept stationary, and the first catheter 3 is pulled backward to slide backward relative to the second catheter 4, so that the filter sleeve 2 is squeezed axially and opened to form a frustum-shaped recovery filter, and the front end periphery of the recovery filter should be in contact with the inner wall of the blood vessel 10 or have only a small gap.

[0065] See also Fig.10 , Fig.11 As shown, the balloon 12 is passed forward from the first catheter 3 to a second preset position via the inner catheter 11, at which time the balloon 12 is located outside the lumen of the first catheter 3 and corresponds to the position of the calcified plaque 20 forming an obstruction in the blood vessel.

[0066] See also Fig.12 , Fig.13 As shown, liquid is injected from the injection head 13, so that the liquid enters the inner cavity of the balloon 12 through the inner catheter 11 to expand the balloon 12. When the balloon 12 expands, its periphery contacts the calcified plaque 20, and then the ultrasonic generating element 6 is started to generate ultrasonic waves for a predetermined time. After the ultrasonic waves act on the calcified plaque 20, the calcified plaque 20 is broken up and separated from the blood vessel wall.

[0067] See also Fig.14 , Fig.15As shown, the liquid flow input port of the inner catheter 11 is opened, that is, the mouth of the liquid injection head 13 at the rear end thereof is kept open, and then the inner catheter 11 is pulled backward, so that the balloon 12 moves backward, and the balloon 12 is squeezed during the backward movement so that the liquid in its inner cavity is discharged from the inner catheter 11, and the rear part of the balloon 12 gradually shrinks, while the front part of the balloon 12 remains in a taut and filled state. In this way, when the balloon 12 moves backward, the broken calcified blocks 20 remaining in the blood vessel are gradually pushed backward, and driven into the recovery filter (that is, the filter sleeve 2 in the open state), so that all the calcified blocks 20 enter the recovery filter, until the balloon 12 is accommodated in the first catheter 3, or directly pulled backward from the first catheter 3.

[0068] Finally, (not shown), the first catheter 3 and the second catheter 4 are synchronously pulled backwards, so that the recovery filter screen with the calcified blocks 20 collected is squeezed and received 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 to be removed from the blood vessel 10.

[0069] In this way, the calcified plaque 20 blocking the peripheral wall of the blood vessel 10 is removed, and the removed calcified plaque 20 is also cleared from the blood vessel 10, avoiding the risk of the calcified plaque 20 remaining in the blood vessel 10 and flowing with the blood.

[0070] The above embodiments are only for illustrating the technical concept and features of the present invention, and their purpose is to enable people familiar with this technology to understand the content of the present invention and implement it. They cannot be used to limit the protection scope of the present invention. Any equivalent changes or modifications made according to the spirit of the present invention should be included in the protection scope of the present invention.

Claims

1. An ultrasonic balloon catheter system, comprising a catheter assembly and an ultrasonic generating element capable of emitting ultrasonic waves, wherein the catheter assembly comprises a balloon catheter, wherein the balloon catheter comprises an inner catheter and an inflatable balloon disposed on the inner catheter, wherein the inner catheter axially passes through the inner cavity of the balloon and a fluid can be introduced into the inner cavity of the balloon, wherein the periphery of the balloon is sealedly connected to the inner catheter, and the ultrasonic generating element is disposed in the inner cavity of the balloon, wherein: The catheter assembly further comprises: A first catheter, which can be relatively slidably sleeved outside the balloon catheter; A second catheter, which can be relatively slidably sleeved outside the first catheter; A filter sleeve, whose peripheral wall is in a mesh shape, the filter sleeve can be relatively slidably sleeved outside the first conduit, the front end of the filter sleeve is fixedly connected to the front part of the first conduit, and the rear end of the filter sleeve is fixedly connected to the front part of the second conduit; The protective sleeve can be relatively slidably sleeved outside the second conduit and the filter sleeve, Wherein, 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 the length of the filter sleeve, and the filter sleeve is cylindrically sleeved outside the first conduit; when the filter sleeve is in the open state, the distance between the first connection position and the second connection position is less than the length of the filter sleeve, and the filter sleeve is frustoconical sleeved outside the first conduit. The balloon can extend out of the first catheter and be located in front of the filter sleeve, and the inflated balloon and the filter sleeve in an opened state can move toward each other.

2. The ultrasonic balloon catheter system according to claim 1, characterized in that: The catheter system also includes a first handle fixedly arranged at the rear of the first catheter and a second handle fixedly arranged at the rear of the second catheter. A lock is provided between the first handle and the second handle to relatively separate or relatively fix the two.

3. The ultrasonic balloon catheter system according to claim 1, characterized in that: The ultrasonic balloon catheter system also includes an ultrasonic control generator for controlling the working state of the ultrasonic generating element, and the ultrasonic generating element is connected to the ultrasonic control generator via a connecting line extending to the outside of the balloon.

4. The ultrasonic balloon catheter system according to claim 1, characterized in that: When the filter sleeve is in the open state, the filter sleeve has a collection working position located outside the protection sleeve, and a recovery working mode accommodated in the protection sleeve.

5. The ultrasonic balloon catheter system according to claim 1, characterized in that: When the filter sleeve is in an open state, the filter sleeve is squeezed and deformed to form the frustum-shaped recovery filter capable of collecting vascular plaques. The recovery filter is in a frustum-shaped shape with a large front end area and a small rear end area.

6. The ultrasonic balloon catheter system according to claim 5, characterized in that: The recovery filter includes a first conical portion and a second conical portion connected at the front end, the first conical portion extends forward and outwardly from the second connection position, the second conical portion extends forward and outwardly from the first connection position, and the second conical portion is located in the first conical portion.

7. The ultrasonic balloon catheter system according to claim 5, characterized in that: The recovery filter is formed when the spacing between the first connection position and the second connection position is less than half the length of the filter sleeve.

8. The ultrasonic balloon catheter system according to claim 1, characterized in that: The filter sleeve is formed by weaving a flexible belt made of metal wire or high-strength PP material.

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