Self-expansion stent thrombectomy catheter with membrane

Abstract

The utility model discloses a membrane self-expansion stent thrombectomy catheter, which relates to the technical field of medical instruments and comprises a thrombectomy catheter and a conveying catheter, the thrombectomy catheter and the conveying catheter are both of bendable flexible structures, the conveying catheter can be movably sleeved outside the thrombectomy catheter, a membrane self-expansion stent is arranged at the head end of the thrombectomy catheter, and the membrane self-expansion stent is arranged at the tail end of the thrombectomy catheter. A barrier film is arranged outside the self-expansion stent with the film, the self-expansion stent with the film is of a net-shaped flexible cover body structure with one end connected with the thrombectomy catheter and the other end open, and the self-expansion stent with the film can be shrunk into the delivery catheter; the thrombectomy catheter and the conveying catheter are used in a matched mode, the self-expansion support with the film is arranged at the end of the thrombectomy catheter to be combined with the thrombectomy balloon to conduct thrombectomy operation, and minimally invasive and thorough thrombectomy is achieved under the condition that blood vessels are cut in an interventional mode instead of a surgical mode. Compared with traditional interventional thrombus suction, thrombus extraction is more thorough; compared with traditional surgical blood vessel incision thrombectomy, wounds and complications caused by surgical incision operation are avoided.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a membrane-covered self-expanding stent thrombectomy catheter. Background Technology

[0002] Thromboembolic diseases include arterial embolism, arterial thrombosis, and venous thromboembolism. Current treatment methods mainly include transcatheter thrombectomy, percutaneous mechanical thrombectomy, catheter-directed thrombolysis, and open thrombectomy.

[0003] Transcatheter thrombectomy is widely used for acute arterial thromboembolism, including acute myocardial infarction and acute peripheral arterial thrombosis. It is simple to perform and inexpensive. Its drawback is that it is less effective at removing thrombi, especially in subacute thrombi, which are often more viscous and cannot be removed by suction alone.

[0004] Percutaneous mechanical thrombectomy, such as the AngioJet mechanical thrombectomy device commonly used in clinical practice, has a strong suction force, achieving rapid and effective removal of blood clots. However, it has two drawbacks: first, mechanical thrombectomy can damage red blood cells, potentially leading to hemolysis and affecting kidney function; second, its high cost limits its widespread adoption.

[0005] Catheter-directed thrombolysis is widely used clinically and is effective for acute peripheral vascular thrombosis, but its effectiveness is not good for subacute thrombosis. Furthermore, some patients with a high risk of bleeding are not suitable candidates for contact thrombolysis.

[0006] Compared to the above methods of thrombectomy, open thrombectomy is the most thorough and effective treatment. However, open thrombectomy is limited to the removal of peripheral acute thrombi and cannot be used for patients with acute myocardial infarction, thus its application is limited. In addition, open thrombectomy is an open surgery, which is more invasive and not suitable for all patients.

[0007] In summary, current clinical practices, including thrombectomy, thrombolysis, and thrombectomy, all have their limitations and are not suitable for all patients. Utility Model Content

[0008] The purpose of this invention is to provide a membrane-covered self-expanding stent thrombectomy catheter to solve the problems existing in the prior art. When used in conjunction with the clinically commonly used thrombectomy balloon, it can be applied to a variety of patients and has the advantages of simple and efficient operation.

[0009] To achieve the above objectives, this utility model provides the following solution:

[0010] This utility model provides a thrombectomy catheter with a membrane-covered self-expanding stent, including a thrombectomy catheter and a delivery catheter. Both the thrombectomy catheter and the delivery catheter are flexible structures that can be bent. The delivery catheter can be movably sleeved on the outside of the thrombectomy catheter. A membrane-covered self-expanding stent is provided at the first end of the thrombectomy catheter. A barrier membrane is provided on the outside of the membrane-covered self-expanding stent. The membrane-covered self-expanding stent is a mesh-like flexible cover structure with one end connected to the thrombectomy catheter and the other end open. The membrane-covered self-expanding stent can retract into the delivery catheter.

[0011] Preferably, the inner diameter of the thrombectomy catheter is 5F-14F, and the length of the thrombectomy catheter is 130cm.

[0012] Preferably, the inner diameter of the delivery conduit is 6F-14F.

[0013] Preferably, the thrombectomy catheter is a polyurethane tube, a silicone tube, or a polyurethane tube.

[0014] Preferably, the membrane-supported self-expanding scaffold is a nickel-titanium shape memory alloy mesh scaffold.

[0015] Preferably, the structure of the membrane-supported self-expanding bracket in its unfolded state is a funnel shape with a diameter that gradually increases from the tail end to the head end.

[0016] Preferably, the membrane-covered self-expanding stent can fit snugly against the blood vessel wall when deployed.

[0017] Preferably, the maximum diameter at the tip of the membrane-covered self-expanding stent in its deployed state is 3mm-16mm, which is used for thrombectomy of blood vessels of corresponding sizes with diameters of 3mm-16mm.

[0018] Preferably, the barrier membrane is a Dacron fiber membrane, a TFE membrane, a PTFE membrane, an ePTFE membrane, a polyester fabric membrane, or a polyester film.

[0019] Preferably, the tail end of the thrombectomy catheter is provided with a first connection port and a second connection port; the first connection port and the main body of the thrombectomy catheter form a Y-shaped structure, and a hemostatic valve is provided at one of the connection ports for flushing the catheter; the second connection port is provided at the tail end of the main body of the thrombectomy catheter for connecting the Y-valve connector.

[0020] The present invention achieves the following beneficial technical effects compared to the prior art:

[0021] This invention provides a membrane-covered self-expanding stent thrombectomy catheter, which, when used in conjunction with a delivery catheter, employs a membrane-covered self-expanding stent at the end of the thrombectomy catheter, combined with a thrombectomy balloon, to perform thrombectomy. This allows for minimally invasive and thorough thrombus removal without surgically opening the blood vessel. Compared to traditional interventional thrombectomy, thrombectomy is more thorough; compared to traditional surgical thrombectomy, it avoids the trauma and complications associated with surgical incision; it is applicable to a variety of patients and also boasts the advantages of simple and efficient operation. Attached Figure Description

[0022] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0023] Figure 1 This is a schematic diagram of the thrombectomy catheter in an embodiment of the present invention;

[0024] Figure 2 This is a structural schematic diagram of operation step one in an embodiment of this utility model;

[0025] Figure 3 This is a structural schematic diagram of operation step two in an embodiment of this utility model;

[0026] Figure 4 This is a structural schematic diagram of operation step three in an embodiment of this utility model;

[0027] Figure 5 This is a structural schematic diagram of operation step four in this embodiment of the present utility model;

[0028] Figure 6 This is a structural schematic diagram of operation step five in an embodiment of this utility model;

[0029] Figure 7 This is a structural schematic diagram of operation step six in an embodiment of this utility model;

[0030] In the diagram: 1. Thrombectomy catheter; 11. Membrane-covered self-expanding stent; 12. Connection port one; 13. Connection port two; 2. Delivery catheter; 3. Blood vessel; 4. Thrombus; 5. Guide wire; 6. Thrombectomy balloon. Detailed Implementation

[0031] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the present utility model.

[0032] The purpose of this invention is to provide a membrane-covered self-expanding stent thrombectomy catheter to solve the problems existing in the prior art.

[0033] To make the above-mentioned objectives, features and advantages of this utility model more apparent and understandable, the utility model will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0034] The membrane-covered self-expanding stent thrombectomy catheter in this embodiment, such as Figures 1-7 As shown, it includes a thrombectomy catheter 1 and a delivery catheter 2. Both the thrombectomy catheter 1 and the delivery catheter 2 are flexible structures that can be bent. The delivery catheter 2 can be movably sleeved on the outside of the thrombectomy catheter 1. The first end of the thrombectomy catheter 1 is provided with a membrane self-expanding support 11. The membrane self-expanding support 11 is provided with a barrier membrane on the outside. The membrane self-expanding support 11 is a mesh flexible cover structure with one end connected to the thrombectomy catheter 1 and the other end open. The membrane self-expanding support 11 can retract into the delivery catheter 2.

[0035] In this specific embodiment, the inner diameter of the thrombectomy catheter 1 is 5F-14F, the inner diameter of the delivery catheter 2 is 6F-14F, the delivery catheter 2 is a commonly used guiding catheter or sheath in clinical practice, and the length of the thrombectomy catheter 1 is 130cm, which is slightly longer than the delivery catheter 2.

[0036] In this specific embodiment, the embolic catheter 1 is a polyurethane tube, a silicone tube, or a polyurethane tube.

[0037] In this specific embodiment, the membrane-covered self-expanding stent 11 is a nickel-titanium shape memory alloy mesh stent. This stent has a flexible structure that can retract into the delivery catheter 2 and automatically expand when the restriction of the delivery catheter 2 is released. When the membrane-covered self-expanding stent 11 is in the expanded state, its specific structure is a funnel shape with the diameter gradually increasing from the tail end to the head end, and it can fit tightly against the blood vessel wall when expanded.

[0038] In this specific embodiment, the maximum diameter at the tip of the self-expanding stent 11 when it is in the deployed state is 3mm-16mm, which is used for thrombectomy of blood vessels 3 of corresponding sizes with diameters of 3mm-16mm.

[0039] In this specific embodiment, the barrier membrane is a Dacron fiber membrane, a TFE membrane, a PTFE membrane, an ePTFE membrane, a polyester fabric membrane, or a polyester membrane. The barrier membrane, together with the membrane-covered self-expanding stent 11, forms a sealed structure to prevent the thrombus 4 collected in the membrane-covered self-expanding stent 11 from leaking out from the stent wall of the membrane-covered self-expanding stent 11.

[0040] In this specific embodiment, the tail end of the thrombectomy catheter 1 is provided with a first connection port 12 and a second connection port 13; the first connection port 12 and the main body of the thrombectomy catheter 1 form a Y-shaped structure, and a hemostatic valve is provided at the first connection port 12 for flushing the tube and preventing blood leakage from the tail end when the thrombectomy catheter 1 is inserted into the blood vessel 3; the second connection port 13 is provided at the tail end of the main body of the thrombectomy catheter 1 for connecting Y valves and other connectors.

[0041] The thrombectomy procedure using the membrane-covered self-expanding stent thrombectomy catheter in this embodiment is as follows:

[0042] Step 1: As Figure 2 As shown, the membrane at the tip of the thrombectomy catheter 1 is compressed from the expandable stent 11 and enters the lumen of the blood vessel 3 through the appropriately sized delivery catheter 2. In this step, the thrombectomy catheter 1 can be advanced into the delivery catheter 2 along the guidewire 5, and the membrane at the tip can be automatically compressed and delivered after being advanced from the expandable stent 11 into the delivery catheter 2. Alternatively, the delivery catheter 2 can be advanced along the guidewire 5 to the proximal end of the blood vessel 3 containing the thrombus 4, and then the thrombectomy catheter 1 can be advanced into the blood vessel 3 along the guidewire 5 and through the delivery catheter 2.

[0043] Step Two: As Figure 3 As shown, the thrombectomy catheter 1 passes through the lumen of the delivery catheter 2, and its tip, the self-expanding stent 11, extends out of the lumen of the delivery catheter 2 and enters the blood vessel 3 containing the thrombus 4. The self-expanding stent 11 at its tip expands to an expanded state and adheres tightly to the blood vessel wall, so that there is no gap between the self-expanding stent 11 and the blood vessel wall.

[0044] Step 3: As Figure 4 As shown, a thrombectomy balloon 6 (such as a Fogart balloon) is inserted into the lumen of the self-expanding stent thrombectomy catheter and inserted into the distal end of the vessel 3 containing the thrombus 4, and the balloon is inflated.

[0045] Step Four: As Figure 5 As shown, the inflated thrombectomy balloon 6 is pulled back, drawing the thrombus 4 from the vessel 3 between the balloon and the self-expanding stent 11 into the lumen of the thrombectomy catheter 1. Because there is no gap between the self-expanding stent 11 at the tip of the catheter 1 and the vessel lumen, when the thrombus 4 is pulled back, it can only be drawn into the lumen of the catheter 1 and the stent at the tip, without leaking through the gap between the catheter 1 and the vessel lumen.

[0046] Step 5: As Figure 6As shown, the thrombectomy balloon 6 is kept inflated. The thrombectomy balloon 6 and the thrombectomy catheter 1 are simultaneously pulled back into the delivery catheter 2. The self-expanding stent 11 with membrane at the tip of the thrombectomy catheter 1 can be retracted to a compressed state and enter the delivery catheter 2. At this time, the thrombectomy balloon 6 is kept inflated and tightly closed to the tip of the self-expanding stent 11 to ensure that the thrombus 4 in the self-expanding stent 11 is squeezed into the lumen of the thrombectomy catheter 1, rather than the thrombus 4 being squeezed into the lumen of the blood vessel 3.

[0047] Step Six: As Figure 7 As shown, when the thrombectomy catheter 1 is pulled back into the matching delivery catheter 2, the thrombectomy balloon 6 is deflated, and the thrombectomy catheter 1 and the balloon 6 are simultaneously pulled back, along with the thrombus 4, through the delivery catheter 2 and out of the body. During the pullback, the balloon is appropriately deflated so that its diameter is the same size as the inner lumen of the delivery catheter 2 to prevent the thrombus 4 that is not completely contained in the thrombectomy catheter 1 from being squeezed out when the covered expansion stent 11 is compressed and pulled back. The thrombectomy catheter 1, the delivery catheter 2, along with the thrombus 4 and the thrombectomy balloon 6 in the lumen, are pulled out of the body through the delivery catheter 2. The entire process of minimally invasive interventional thrombectomy is completed.

[0048] If necessary, the above process can be repeated until all blood clots in the blood vessels are removed.

[0049] This utility model uses specific examples to illustrate its principles and implementation methods. The above description of the embodiments is only for the purpose of helping to understand the method and core idea of ​​this utility model. At the same time, for those skilled in the art, there will be changes in the specific implementation methods and application scope based on the idea of ​​this utility model. In summary, the content of this specification should not be construed as a limitation of this utility model.

Claims

1. A membrane-covered self-expanding stent thrombectomy catheter, characterized in that: The device includes a thrombectomy catheter and a delivery catheter, both of which are flexible structures capable of bending. The delivery catheter can be movably fitted onto the outside of the thrombectomy catheter. The first end of the thrombectomy catheter is provided with a membrane-covered self-expanding support, and the outside of the membrane-covered self-expanding support is provided with a barrier membrane. The membrane-covered self-expanding support is a mesh-like flexible cover structure with one end connected to the thrombectomy catheter and the other end open. The membrane-covered self-expanding support can retract into the delivery catheter.

2. The membrane-covered self-expanding stent thrombectomy catheter according to claim 1, characterized in that: The inner diameter of the thrombectomy catheter is 5F-14F, and the length of the thrombectomy catheter is 130cm.

3. The membrane-covered self-expanding stent thrombectomy catheter according to claim 1, characterized in that: The inner diameter of the delivery conduit is 6F-14F.

4. The membrane-covered self-expanding stent thrombectomy catheter according to claim 1, characterized in that: The thrombectomy catheter is a polyurethane tube, a silicone tube, or a polyurethane tube.

5. The membrane-covered self-expanding stent thrombectomy catheter according to claim 1, characterized in that: The membrane-supported self-expanding scaffold is a nickel-titanium shape memory alloy mesh scaffold.

6. The membrane-covered self-expanding stent thrombectomy catheter according to claim 5, characterized in that: When the membrane-supported self-expanding bracket is in the unfolded state, its structure is a funnel shape with the diameter gradually increasing from the tail end to the head end.

7. The membrane-covered self-expanding stent thrombectomy catheter according to claim 6, characterized in that: The membrane-covered self-expanding stent can fit snugly against the blood vessel wall when deployed.

8. The membrane-covered self-expanding stent thrombectomy catheter according to claim 6, characterized in that: The maximum diameter at the tip of the self-expanding membrane stent in its deployed state is 3mm-16mm, which is used for thrombectomy of blood vessels of corresponding sizes with diameters of 3mm-16mm.

9. The membrane-covered self-expanding stent thrombectomy catheter according to claim 1, characterized in that: The barrier membrane is a Dacron fiber membrane, a TFE membrane, a PTFE membrane, an ePTFE membrane, a polyester fabric membrane, or a polyester film.

10. The membrane-covered self-expanding stent thrombectomy catheter according to claim 1, characterized in that: The tail end of the thrombectomy catheter is provided with a first connection port and a second connection port; the first connection port and the main body of the thrombectomy catheter form a Y-shaped structure, and a hemostatic valve is provided at one of the first connection ports for flushing the catheter; the second connection port is located at the tail end of the main body of the thrombectomy catheter for connecting the Y-valve connector.

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