Catheter assembly capable of clearing vascular occlusive plaque

Abstract

The application discloses a catheter assembly capable of removing vascular obstruction plaque, which comprises a balloon catheter, the balloon catheter comprises an inner catheter and a balloon arranged on the inner catheter and capable of being inflated, the catheter assembly further comprises a first catheter capable of being sleeved on the balloon catheter in a relatively sliding mode, a second catheter capable of being sleeved on the first catheter in a relatively sliding mode, and a filter screen sleeve with a meshed peripheral wall, the filter screen sleeve is capable of being sleeved on the first sleeve in a relatively sliding mode, a front end of the filter screen sleeve is fixedly connected to a front part of the first catheter, and a rear end of the filter screen sleeve is fixedly connected to a front part of the second catheter. After removing the calcified plaque obstructing in the blood vessel, the broken calcified plaque can be removed from the blood vessel by using the catheter assembly, so that the risk caused by the calcified plaque remaining in the blood vessel and flowing with the blood is avoided. The catheter assembly has simple structure and is convenient to operate.

Description

TECHNICAL FIELD

[0001] The present application relates to a catheter assembly capable of removing vascular obstruction plaque. BACKGROUND

[0002] Vascular calcification refers to calcium deposition in the wall of arteriovenous vessels, that is, calcified plaque in the inner wall of arteriovenous vessels, which seriously threatens the health of patients. In recent years, for calcium deposition in blood vessels, a small surgical procedure is usually used to insert a catheter provided with a balloon into the blood vessel, and the balloon is inflated when it reaches the calcium deposition site, and a high pressure pulse is released by working with the electrode arranged in the balloon, so as to form a shock wave, which propagates through the fluid and hits the balloon wall and the calcified area, so as to use the repeated pulse to destroy the calcium deposition.

[0003] In the prior art, the method of generating a shock wave in the human body is mostly used to remove the calcified plaque in the human blood vessel, which needs to generate a high pressure pulse in the human body, and the liquid filled in the balloon is made to generate bubbles by the generated pulse, so that the bubbles act on the balloon wall when they break, and then act on the calcified plaque. However, the thickness of the blood vessels at different positions of 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 vessels, so the above-mentioned technology of using pulse to remove the calcified plaque in the human body has not been applied in clinic.

[0004] In order to safely and effectively remove the calcified plaque in the blood vessel, a Chinese patent with publication number CN 109953799 A discloses an ultrasonic balloon catheter assembly, a catheter system and a use method, in which the method of forming ultrasonic waves in the human body is used to remove the calcified plaque in the human blood vessel. However, this scheme only solves the problem of removing the calcified plaque, but the removed plaque still remains in the blood vessel, and if it cannot be taken out of the human blood vessel, it will flow to other parts of the body, such as the heart, which will bring great threat to the health of the patient after the operation. SUMMARY

[0005] The purpose of the present application is to provide a catheter assembly capable of removing vascular obstruction plaque, so as to remove the calcified plaque in the blood vessel from the blood vessel.

[0006] To achieve the above object, the technical scheme adopted by the present application is as follows: A catheter assembly capable of removing vascular obstruction plaque, 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 being inflated, the inner catheter passing through the balloon lumen in the axial direction and capable of passing fluid into the balloon lumen, the peripheral part of the balloon being sealingly connected with the inner catheter, the catheter assembly further comprising a first catheter capable of being sleeved on the balloon catheter in a relative sliding manner, a second catheter capable of being sleeved on the first catheter in a relative sliding manner, and a filter sleeve with a meshed wall, the filter sleeve being capable of being sleeved on the first sleeve in a relative sliding manner, the front end part of the filter sleeve being fixedly connected with the front part of the first catheter, and the rear end part of the filter sleeve being fixedly connected with the front part of the second catheter.

[0007] Preferably, the front end part of the filter sleeve is fixedly connected with a first connection position of the first catheter, the rear end part of the filter sleeve is fixedly connected with a second connection position of the second catheter, the filter sleeve has a retracted state and an opened 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 on the first catheter; when the filter sleeve is in the opened 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 conically sleeved on the first catheter.

[0008] Further, when the filter sleeve is in the opened state, the filter sleeve is deformed by extrusion to form a conical recovery filter capable of collecting vascular plaque.

[0009] Still further, the recovery filter is conical with a large front end area and a small rear end area.

[0010] Still further, the recovery filter comprises a first conical part and a second conical part, the front end part of the first conical part is inclinedly extended forward and outward from the second connection position, the front end part of the second conical part is inclinedly extended forward and outward from the first connection position, and the second conical part is located in the first conical part.

[0011] Still further, the recovery filter is formed when the distance between the first connection position and the second connection position is smaller than half the length of the filter sleeve.

[0012] Preferably, the filter sleeve is cylindrically woven by a flexible band made of metal wire or high-strength PP material.

[0013] Preferably, the conduit assembly further includes a protective sleeve that can be slidably fitted over the second conduit and the filter sleeve.

[0014] Preferably, a first handle is fixedly provided at the rear of the first conduit, and a second handle is fixedly provided at the rear of the second conduit, with a latch between the first handle and the second handle capable of fixing the two relative to each other.

[0015] Preferably, the catheter assembly further includes a generating element capable of emitting ultrasonic waves or shock waves, the generating element being disposed within the lumen of the balloon.

[0016] Due to the application of the above technical solution, the present invention has the following advantages compared with the prior art: The catheter assembly of the present invention, by providing a deformable filter sleeve, forms a recovery filter capable of recovering calcified plaques after axial compression. Thus, after removing calcified plaques obstructing the blood vessel, the catheter assembly can be used to remove the broken calcified plaques from the blood vessel, avoiding the risks caused by calcified plaques remaining in the blood vessel and flowing with the blood. The catheter assembly has a simple structure and is easy to operate. Attached Figure Description

[0017] Appendix Figure 1 This is a schematic diagram of the overall structure of the ultrasonic balloon catheter system according to Embodiment 1 of the present invention;

[0018] Appendix Figure 2 This is a side view of the ultrasonic balloon catheter system of Example 1;

[0019] Appendix Figure 3 For the attached Figure 2 Schematic diagram of the cross-sectional structure of the PP section;

[0020] Appendix Figure 4 This is a longitudinal cross-sectional schematic diagram of the initial state of the ultrasonic balloon catheter system in Example 1.

[0021] Appendix Figure 5 for Figure 4 Enlarged diagram of section A in the middle;

[0022] Appendix Figure 6 This is a longitudinal cross-sectional view of the first and second catheters in the ultrasonic balloon catheter system of Example 1 when they are extended to their initial preset positions;

[0023] Appendix Figure 7 for Figure 6 Enlarged schematic diagram of section B in the middle;

[0024] Appendix Figure 8 This is a longitudinal cross-sectional view of the ultrasonic balloon catheter system of Example 1 after the filter sleeve has been converted to the open state;

[0025] AppendixFigure 9 For Figure 8 Enlarged view of section C;

[0026] Attached Figure 10 For Figure 8 On the basis of, the balloon forward to the second preset position of the longitudinal section view schematic diagram;

[0027] Attached Figure 11 For Figure 10 Enlarged view of section D;

[0028] Attached Figure 12 For Figure 10 On the basis of, the balloon after injecting liquid inflation of the longitudinal section view schematic diagram;

[0029] Attached Figure 13 For Figure 12 Enlarged view of section E;

[0030] Attached Figure 14 For Figure 12 On the basis of, the balloon gradually backward movement and drainage process of the longitudinal section view schematic diagram;

[0031] Attached Figure 15 For Figure 14 Enlarged view of section F;

[0032] Wherein: 1, balloon catheter; 11, inner catheter; 12, balloon; 13, liquid injection head; 2, filter sleeve; 21, first tapered portion; 22, second tapered portion; 3, first catheter; 4, second catheter; 5, protective sleeve; 6, ultrasonic wave generating element; 7, operating handle; 70, handle seat; 71, first handle; 72, second handle; 73, limiting groove; 8, ultrasonic wave control generator; 9, connecting line; 10, blood vessel; 20, calcified plaque. DETAILED DESCRIPTION

[0033] The technical solutions of the present application will be further described below in combination with the drawings and specific examples.

[0034] Example 1

[0035] The following description of the front and rear directions is defined with reference to the direction of insertion of the catheter assembly into the blood vessel 10 when the catheter assembly is in use, wherein the end that enters the blood vessel 10 first is the front, and vice versa.

[0036] Referring to Figures 1 to 3 An ultrasonic balloon catheter system, comprising a catheter assembly and an ultrasonic wave generating element 6 capable of emitting ultrasonic waves, and an ultrasonic wave control generator 8 for controlling the operation of the ultrasonic wave generating element 6.

[0037] The catheter assembly comprises a balloon catheter 1, which comprises an inner catheter 11 and a balloon 12 arranged in front of the inner catheter 11 and capable of being inflated, the inner catheter 11 axially passes through the inner cavity of the balloon 12 and is capable of passing fluid into the inner cavity of the balloon 12, the periphery of the balloon 12 is sealingly connected with the inner catheter 11, the inner catheter 11 in the inner cavity of the balloon 12 has a plurality of liquid flow holes, which communicate 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 a liquid injection head 13, by injecting liquid into the liquid injection head 13, the liquid enters the inner cavity of the balloon 12 through the liquid flow holes of the inner catheter 11 to inflate the balloon 12, or the liquid flows out of the balloon 12 from the liquid flow holes into the inner catheter 11 to deflate the balloon 12. The ultrasonic wave generating element 6 is arranged on the inner catheter 11 and located in the inner cavity of the balloon 12, one end of the connecting wire 9 is connected with the ultrasonic wave generating element 6, and the other end is connected with the ultrasonic wave control generator 8.

[0038] The catheter assembly further comprises:

[0039] a first catheter 3, which is sleeved outside the balloon catheter 1 in a relatively slidable manner;

[0040] a second catheter 4, which is sleeved outside the first catheter 3 in a relatively slidable manner;

[0041] a filter sleeve 2, which is cylindrical when not being squeezed, and the peripheral wall thereof is in a mesh shape, which can be woven by a flexible belt made of high-strength PP material or by a metal wire, preferably a titanium alloy wire. The filter sleeve 2 is sleeved outside the first catheter 3 in a relatively slidable manner, the front end of the filter sleeve 2 is fixedly connected to the front part of the first catheter 3, and the connection position is the first connection position; the rear end of the filter sleeve 2 is fixedly connected to the front part of the second catheter 4, and the connection position is the second connection position;

[0042] a protective sleeve 5, which is sleeved outside the second catheter 4 and the filter sleeve 2 in a relatively slidable manner.

[0043] Wherein, the filter sleeve 2 has a retracted state and an open state according to the state of being squeezed in the axial direction, 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 sleeved outside the first catheter 3 in a cylindrical shape; when the filter sleeve 2 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 2, and the filter sleeve 2 is axially squeezed and deformed to be sleeved outside the first catheter 2 in a frustoconical shape.

[0044] In the specific use, the filter sleeve 2 is squeezed and deformed to form a conical shape in the open state, so as to collect the vascular plaque 20, and the collected filter sleeve is in a conical shape with a large front end area and a small rear end area, so that the calcified plaque in front of the filter sleeve 2 can enter the collected filter sleeve and be collected when moving backward.

[0045] Specifically referring to Figures 8 to 15 As shown, the collected filter sleeve 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 collected filter sleeve 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 2. The filter sleeve 2 in the open state also has a collection working state outside the protection sleeve 5 and a recovery working mode stored in the protection sleeve 5.

[0046] Referring to the drawings, the catheter system further includes an operating handle 7, which includes a first handle 71 fixed to the rear of the first catheter 3, a second handle 72 fixed to the rear of the second catheter 4, and a lock (not shown) arranged between the first handle 71 and the second handle 72 to separate or fix the two relative to each other. 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 released 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 to change from the storage state to the open state.

[0047] The operating handle 7 further includes a handle seat 70 fixed to the rear of the protection sleeve 5, the handle seat 70 is provided with a limiting groove 73 extending in the forward and backward direction, and the first handle 71 and the second handle 72 are arranged in the limiting groove 73 in a relative sliding manner, so that the sliding positions of the first catheter 3 and the second catheter 4 can be limited in actual operation, and when the first handle 71 and / or the second handle 72 are fixed relative to the handle seat 70, the protection sleeve 5, the first catheter 3 and / or the second catheter 4 can also be ensured to slide synchronously.

[0048] The use method of the ultrasonic balloon catheter system of the embodiment will be described below in combination with the drawings:

[0049] Referring to Figures 3 to 5As shown, the balloon 12 is first kept in an un-inflated state and located in the first catheter 3, and the filter sleeve 2 is in a retracted state, the filter sleeve 2 is axially elongatedly 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 forwardly inserted into the blood vessel 10 to an initial preset position, which is located behind the blood vessel occlusion plaque 20 in the blood vessel 10.

[0050] As shown in Figure 6 , Figure 7 As shown, the protective sleeve 5 is kept stationary, the first catheter 3, the second catheter 4 and the filter sleeve 2 are synchronously driven to slide forwardly out of the protective sleeve 5 to a first preset position, which is located in front of the initial preset position and behind the blood vessel occlusion plaque 20 in the blood vessel 10.

[0051] As shown in Figure 8 , Figure 9 As shown, the second catheter 4 is kept stationary, the first catheter 3 is pulled backwardly to slide backwardly relative to the second catheter 4, so that the filter sleeve 2 is axially squeezed to be opened to form a conical recovery filter, the front end of the recovery filter should be in contact with the inner wall of the blood vessel 10 or only have a small gap.

[0052] As shown in Figure 10 , Figure 11 As shown, the balloon 12 is forwardly inserted out of the first catheter 3 to a second preset position via the inner catheter 11, at this time, the balloon 12 is located outside the lumen of the first catheter 3 and corresponds to the position of the calcified plaque 20 which forms the occlusion in the blood vessel.

[0053] As shown in Figure 12 , Figure 13 As shown, the liquid is injected from the liquid injection head 13, so that the liquid enters the inner cavity of the balloon 12 via the inner catheter 11 to inflate the balloon 12, when the balloon 12 is inflated, its outer periphery contacts the calcified plaque 20, then the ultrasonic wave 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 and separated from the blood vessel wall.

[0054] As shown in Figure 14 , Figure 15As shown, the liquid inflow port of the inner catheter 11 is opened, i.e. the rear end of the liquid injection head 13 is kept open, and then the inner catheter 11 is pulled backward, so that the balloon 12 moves backward and is squeezed during the backward movement, so that the liquid in the inner cavity of the balloon 12 is discharged 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 inflated and full. Thus, when the balloon 12 moves backward, the calcified plaque 20 broken in the blood vessel is gradually pushed backward to the recovery filter (i.e. the filter sleeve 2 in the open state), so that the calcified plaque 20 is all entered into the recovery filter, until the balloon 12 is accommodated in the first catheter 3 or directly pulled out from the first catheter 3.

[0055] Finally, as shown, the first catheter 3 and the second catheter 4 are pulled backward synchronously, so that the recovery filter collecting the calcified plaque 20 is squeezed and accommodated in the protection sleeve 5. At this time, the first catheter 3, the second catheter 4 and the protection sleeve 5 can be driven to move backward synchronously, so as to be taken out from the blood vessel 10.

[0056] Thus, the calcified plaque 20 removed from the blood vessel 10 is removed from the blood vessel 10, so as to avoid the risk that the calcified plaque 20 still remains in the blood vessel 10 and flows with the blood.

[0057] Embodiment 2

[0058] As shown, the main difference between the catheter assembly of the present embodiment and the catheter assembly of Embodiment 1 is the different generating element.

[0059] In the present embodiment, the ultrasonic wave generating element 6 is replaced by a generating element capable of emitting shock waves, so as to emit shock waves to break and peel the calcified plaque 20 blocked in the blood vessel from the blood vessel wall during operation.

[0060] The above embodiments are only for illustrating the technical concept and characteristics of the present application, and the purpose is to enable those skilled in the art to understand the content of the present application and implement it, and cannot limit the protection scope of the present application. Any equivalent changes or modifications made according to the spirit and essence of the present application shall be covered within the protection scope of the present application.

Claims

1. A catheter assembly capable of removing vascular obstruction plaque, the catheter assembly comprising a balloon catheter, the balloon catheter comprising an inner catheter and a balloon disposed on the inner catheter and capable of being inflated, the inner catheter passing through the balloon lumen in an axial direction and capable of passing fluid into the balloon lumen, the balloon periphery being sealingly connected with the inner catheter, characterized in that: the catheter assembly further comprises a first catheter capable of being sleeved on the balloon catheter in a relative sliding manner, a second catheter capable of being sleeved on the first catheter in a relative sliding manner, and a mesh sleeve with a meshed wall, the mesh sleeve being capable of being sleeved on the first catheter in a relative sliding manner, a front end portion of the mesh sleeve being fixedly connected on a front portion of the first catheter, and a rear end portion of the mesh sleeve being fixedly connected on a front portion of the second catheter, wherein, the front end portion of the mesh sleeve is fixedly connected to a first connection position of the first catheter, the rear end portion of the mesh sleeve is fixedly connected to a second connection position of the second catheter, the mesh sleeve has a retracted state and an open state, when the mesh sleeve is in the retracted state, a distance between the first connection position and the second connection position is the same as a length of the mesh sleeve, and the mesh sleeve is sleeved on the first catheter in a cylindrical shape; when the mesh 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 mesh sleeve, and the mesh sleeve is sleeved on the first catheter in a frustoconical shape, the balloon lumen is further provided with a generating element capable of generating ultrasonic waves or shock waves, the balloon is capable of extending out of the first catheter and being located in front of the mesh sleeve, and the inflated balloon and the mesh sleeve in the open state are capable of moving towards each other, the catheter assembly further comprises a protective sleeve capable of being sleeved on the second catheter and the mesh sleeve in a relative sliding manner, the mesh sleeve in the open state further has a collection mode located outside the protective sleeve and a recycling mode accommodated in the protective sleeve. When the mesh sleeve is in the open state, the mesh sleeve is deformed to form the frustoconical recycling mesh capable of collecting vascular plaque. The recycling mesh is in a frustoconical shape with a large front end area and a small rear end area. The recycling mesh comprises a first tapered portion and a second tapered portion connected at a front end portion, the first tapered portion extends forward and outward from the second connection position, the second tapered portion extends forward and outward from the first connection position, and the second tapered portion is located in the first tapered portion. The recycling mesh is formed when a distance between the first connection position and the second connection position is less than half the length of the mesh sleeve.

2. The catheter assembly capable of clearing vascular occlusive plaque of claim 1, wherein: The mesh sleeve is formed by weaving flexible belts made of metal wires or high-strength PP materials.

3. The catheter assembly capable of clearing vascular occlusive plaque of claim 2, wherein: A rear portion of the first catheter is fixedly provided with a first handle, a rear portion of the second catheter is fixedly provided with a second handle, and a lock is provided between the first handle and the second handle to fix the two handles relative to each other.

4. The catheter assembly capable of clearing vascular occlusive plaque of claim 2, wherein: ​ 5. The catheter assembly capable of clearing vascular occlusive plaque of claim 2, wherein: ​ 6. The catheter assembly capable of clearing vascular occlusive plaque of claim 1, wherein: ​ 7. The catheter assembly capable of clearing vascular occlusive plaque of claim 1, wherein: ​

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