Split-type serrated thrombus-breaking balloon catheter

Abstract

The present invention discloses a split-type sawtooth thrombus-breaking balloon catheter, comprising a catheter cavity joint and a balloon cavity joint, the right side of the catheter cavity joint is interconnected with the balloon cavity joint, the right end of the catheter cavity joint is interconnected with the left end of the balloon tube, the inner cavity of the balloon tube is provided with a guide tube, the upper right end of the balloon tube is interconnected with a small balloon, the guide tube and the balloon tube form a double-lumen catheter, and the outer diameter of the double-lumen catheter is 1.91mm, and the space and function are independent of each other, the lower right end of the balloon tube is interconnected with a large balloon, the middle end of the guide tube is provided with a proximal marking point, and the right end of the guide tube is provided with a distal marking point. The split-type sawtooth thrombus-breaking balloon catheter of the present invention can be operated in two directions perpendicular to each other to cut and crush the thrombus, reduce the dosage of thrombolytic drugs, and increase the thrombolytic effect at the same time; in addition, the risk of pulmonary embolism caused by thrombus shedding can also be reduced.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, in particular to a split-type sawtooth thrombus-breaking balloon catheter. Background Art

[0002] Venous thromboembolism (VTE) includes deep vein thrombosis (DVT) and pulmonary thromboembolism (PTE), which are manifestations of the same disease at different stages of onset and in different tissues and organs. Deep vein thrombosis of the lower extremities refers to a clinical syndrome in which blood in the deep vein system coagulates and forms thrombi due to various reasons, causing blood reflux obstruction in the corresponding blood vessels. It is currently believed that venous blood flow stagnation, venous wall damage and hypercoagulable state of blood are the three major causes of deep vein thrombosis. When a thrombus in the lower extremities breaks off, the thrombus can flow into the pulmonary artery along the blood flow, causing fatal pulmonary embolism and seriously endangering the patient's life. In the United States, the incidence of VTE is about 1.17 / 1000 person-years, with about 350,000 new cases of VTE each year; the incidence of VTE in my country is also gradually increasing, and VTE is still the third leading cause of death from vascular diseases.

[0003] At present, the treatment options for deep vein thrombosis of the lower extremities mainly include conservative drug treatment and surgical treatment. Among them, anticoagulant therapy is the most basic method of DVT, which can effectively inhibit the spread of thrombus, accelerate thrombus dissolution and vascular recanalization. Thrombolytic therapy includes systemic thrombolysis and catheter thrombolysis. Systemic thrombolysis is the injection of thrombolytic drugs through peripheral veins, which has low thrombolytic efficiency and high risk of bleeding; catheter thrombolysis is the injection of thrombolytic drugs directly into the thrombus through a thrombolytic catheter with side holes, which reduces the dose of thrombolytic drugs and reduces the risk of bleeding, but it is still difficult to completely remove all thrombi. Surgical thrombectomy requires cutting the vein, and then using the Fogarty catheter to remove the intravenous thrombus; but it is often accompanied by complications such as venous valve and vascular wall damage, bleeding, etc. Drug-mechanical combined thrombectomy is to crush and aspirate the thrombus out of the body by the principle of negative pressure suction, and at the same time combine it with local thrombolytic drug jet perfusion, which can accelerate thrombus dissolution and reduce the dose of thrombolytic drugs; but this surgical method is expensive, and most patients find it difficult to pay the high surgical fee, which limits its further use. Therefore, there is an urgent need for a medical device that has good clinical effects, can quickly remove blood clots, and is cost-effective. We have invented the split-type balloon thrombectomy catheter, hoping to quickly and thoroughly remove blood clots, restore venous blood flow, and reduce the financial burden on patients. Summary of the invention

[0004] The purpose of the present invention is to provide a split-type serrated thrombus-breaking balloon catheter to solve the problems raised in the above-mentioned background technology.

[0005] To achieve the above-mentioned purpose, the present invention provides the following technical solutions: a split-type serrated thrombus-breaking balloon catheter, comprising a catheter cavity joint and a balloon cavity joint, the upper right side of the catheter cavity joint is interconnected with the balloon cavity joint, the right end of the catheter cavity joint is interconnected with the left end of the balloon tube, the inner cavity of the balloon tube is provided with a guide tube, the upper right end of the balloon tube is interconnected with a small balloon, the lower right end of the balloon tube is connected with a large balloon, the middle end of the guide tube is provided with a proximal marking point, and the right end of the guide tube is provided with a distal marking point.

[0006] Preferably, the guide tube and the balloon tube form a double-lumen catheter, and the outer diameter of the double-lumen catheter is 1.91 mm, and the space and function are independent of each other.

[0007] Preferably, the large balloon and the small balloon are arranged in a serrated shape in an alternating manner in series in the horizontal direction of the guide tube. In the 360° direction of the circumference of the guide tube, the large balloon and the small balloon are arranged correspondingly in sequence. The large balloon and the small balloon form a serrated balloon that is arranged in series in an alternating manner in a serrated shape. The serrated balloon has a length of 40mm-80mm and a diameter of 8-18mm. The distal and proximal ends of the serrated balloon have X-ray-opaque marking points.

[0008] Preferably, the inner diameter of the guide tube is 0.9 mm, the guide tube is communicated with the catheter cavity connector, and the guide wire enters the guide tube cavity through the catheter cavity connector.

[0009] Preferably, the balloon tube is communicated with the balloon cavity connector.

[0010] Preferably, the small balloon and the large balloon are both semi-elliptical, with a working pressure of 6 atm and a bursting pressure of 18 atm.

[0011] Compared with the prior art, the beneficial effects of the present invention are as follows: the split-type serrated thrombus-breaking balloon catheter is pushed, withdrawn, and rotated 360° in the blood vessel cavity, repeatedly cutting and crushing the thrombus in two mutually perpendicular directions; due to the innovative serrated balloon structure, the efficiency of cutting and crushing the thrombus can be significantly improved, and the thrombus particles after crushing are smaller, while reducing the residual thrombus on the blood vessel wall; the dosage of thrombolytic drugs can be reduced, and the risk of complications such as bleeding and pulmonary embolism can be reduced. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 It is a schematic diagram of the structure of the present invention;

[0013] Figure 2 It is a schematic diagram of the cross-sectional structure of the guide tube 3 and the balloon tube 4 of the present invention;

[0014] Figure 3 It is a schematic diagram of the local structure of the present invention.

[0015] In the figure: 1. catheter cavity joint, 2. balloon cavity joint, 3. guide tube, 4. balloon tube, 5. proximal marking point, 6. small balloon, 7. large balloon, 8. distal marking point. DETAILED DESCRIPTION

[0016] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0017] In the description of the present invention, it should be noted that the terms "vertical", "upper", "lower", "horizontal", etc. indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, which are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific position, be constructed and operated in a specific position, and therefore cannot be understood as limiting the present invention. In addition, "first", "second", "third", and "fourth" are only used for descriptive purposes and cannot be understood as indicating or implying relative importance.

[0018] In the description of the present invention, it is also necessary to explain that, unless otherwise clearly specified and limited, the terms "set", "install", "connect", and "connect" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection, it can be a mechanical connection, it can be an electrical connection, it can be a direct connection, it can be connected through an intermediate medium, and it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0019] See also Figure 1-3The present invention provides a technical solution: a split-type serrated thrombus-breaking balloon catheter, comprising a catheter cavity joint 1 and a balloon cavity joint 2, the upper right side of the catheter cavity joint 1 is connected to the balloon cavity joint 2, the right end of the catheter cavity joint 1 is connected to the left end of a balloon tube 4, the balloon tube 4 is communicated with the balloon cavity joint 2, the inner cavity of the balloon tube 4 is provided with a guide tube 3, the inner diameter of the guide tube 3 is 0.9 mm, the guide tube 3 is communicated with the catheter cavity joint 1, the guide wire enters the guide tube 3 cavity through the catheter cavity joint 1, the guide tube 3 and the balloon tube 4 form a double-lumen catheter, and the outer diameter of the double-lumen catheter is 1.91 mm, and the space and function are independent of each other, the upper right end of the balloon tube 4 is connected to a small balloon 6, the lower right end of the balloon tube 4 is connected to a large balloon 7, and the large balloon 7 and the small balloon 6 are arranged in a serrated shape in a series alternating manner in the horizontal direction of the guide tube 3. In the 360° direction of the circumference of the guide tube, the large balloon 7 and the small balloon 6 are arranged in sequence. The small balloon 6 and the large balloon 7 are both semi-elliptical, with a working pressure of 6atm and a bursting pressure of 18atm. The large balloon 7 and the small balloon 6 form a serrated balloon that is alternately arranged in a serrated shape in series. The length of the serrated balloon is 40mm-80mm, and the diameter is 8-18mm; the distal and proximal ends of the serrated balloon have marking points that are not transparent to X-rays. The middle end of the guide tube 3 is provided with a proximal marking point 5, which are respectively a proximal marking point 5 and a distal marking point 8. The right end of the guide tube 3 is provided with a distal marking point 8, which is helpful for accurately positioning the balloon in the blood vessel. Under X-ray fluoroscopy, the proximal marking point 5 and the distal marking point 8 cover the thrombus segment of the blood vessel; the serrated balloon is pushed and retracted in a direction parallel to the blood vessel, and the serrated structure composed of the small balloon 6 and the large balloon 7 cuts and crushes the thrombus. In addition, as shown in the attached Figure 3 As shown in the schematic diagram of the balloon cross-sectional structure, the small balloon 6 and the large balloon 7 are arranged alternately up and down on the guide tube 3. When the serrated balloon rotates 360° along the circumference of the blood vessel, the thrombus can also be cut and crushed. Therefore, if the serrated balloon catheter is rotated 360° along the circumference of the blood vessel, and the pushing and retracting operations are performed in the parallel direction of the blood vessel, the thrombus can be cut and crushed in two mutually perpendicular directions at the same time. This can efficiently, quickly and thoroughly crush the thrombus; reduce the dosage of thrombolytic drugs and improve the thrombolytic effect; and also reduce the number of balloon operations in the blood vessel cavity and reduce the risk of the balloon damaging the blood vessel wall.

[0020] The method for using the split-type sawtooth thrombus-breaking balloon catheter of the present invention mainly comprises the following steps:

[0021] (1) The tip of the split-type serrated thrombus-breaking balloon catheter is placed into the vascular sheath, and the guide wire enters the lumen of the guide tube 3 through the catheter lumen connector 1, and then enters the vascular lumen. The guide wire plays a role in selecting the catheter and providing support.

[0022] (2) Under the guidance and support of the guidewire, the serrated balloon of the split-type serrated thrombus-breaking balloon catheter partially enters the thrombus segment; under X-ray fluoroscopy, the position of the serrated balloon is adjusted according to the proximal marking point 5 and the distal marking point 8 of the balloon to ensure that the length of the serrated balloon can completely cover the thrombus.

[0023] (3) The pressure pump connector is connected to the balloon cavity connector 2, and the developer is injected to fully expand the small balloon 6 and the large balloon 7 to reach the working pressure of the serrated balloon of 6 atm.

[0024] (4) In the direction parallel to the blood vessel, the serrated thrombus-breaking balloon catheter is pushed and retracted, and the serrated balloon cuts and crushes the thrombus in the horizontal direction.

[0025] (5) The serrated thrombus-breaking balloon catheter is rotated 360° along the circumference of the blood vessel. The serrated balloon cuts and crushes the thrombus in a direction perpendicular to the horizontal direction of the blood vessel.

[0026] (6) The above operations (4) and (5) can be performed simultaneously to quickly and efficiently cut and crush the thrombus in two mutually perpendicular directions.

[0027] (7) Angiography is used to determine the effectiveness of the serrated balloon in pulverizing thrombi. If the thrombi are completely cut and pulverized without residue, the developing solution in the balloon is withdrawn under negative pressure using a pressure pump.

[0028] (8) Under X-ray fluoroscopy, confirm that the small balloon 6 and the large balloon 7 are deflated and no developing solution remains, and then withdraw the serrated thrombus-breaking balloon catheter as a whole until it is out of the body.

[0029] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A split-type sawtooth thrombus-breaking balloon catheter, comprising a catheter cavity joint (1) and a balloon cavity joint (2), characterized in that: The upper right side of the catheter cavity joint (1) is connected to the balloon cavity joint (2), the right end of the catheter cavity joint (1) is connected to the left end of the balloon tube (4), the inner cavity of the balloon tube (4) is provided with a guide tube (3), the upper right end of the balloon tube (4) is connected to the small balloon (6), the lower right end of the balloon tube (4) is connected to the large balloon (7), the middle end of the guide tube (3) is provided with a proximal marking point (5), and the right end of the guide tube (3) is provided with a distal marking point (8); the large balloon ( The large balloon (7) and the small balloon (6) are arranged in a zigzag manner in a series alternating manner in the horizontal direction of the guide tube (3); in the 360° direction of the circumference of the guide tube, the large balloon (7) and the small balloon (6) are arranged in sequence, and the large balloon (7) and the small balloon (6) form a zigzag balloon that is arranged in series in an alternating manner in a zigzag manner. The zigzag balloon has a length of 40 mm to 80 mm and a diameter of 8 to 18 mm. Both the distal end and the proximal end of the zigzag balloon have X-ray-proof marking points. The balloon tube (4) is connected to the balloon cavity joint (2).

2. The serrated thrombus-breaking balloon catheter according to claim 1, characterized in that: The guide tube (3) and the balloon tube (4) form a double-lumen catheter, and the outer diameter of the double-lumen catheter is 1.91 mm, and the space and function are independent of each other.

3. The serrated thrombus-breaking balloon catheter according to claim 1, characterized in that: The inner diameter of the guide tube (3) is 0.9 mm. The guide tube (3) is in communication with the catheter cavity connector (1), and the guide wire enters the cavity of the guide tube (3) through the catheter cavity connector (1).

4. The serrated thrombus-breaking balloon catheter according to claim 1, characterized in that: The small balloon (6) and the large balloon (7) are both semi-elliptical in shape, and have a working pressure of 6 atm and a bursting pressure of 18 atm.

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