Extended suction catheter and catheter system with same

Abstract

The utility model provides an extended aspiration catheter and a catheter system with the same, the extended aspiration catheter comprises a catheter body, a push rod, a catheter seat, a positioning balloon, a distal tip and a microneedle, a delivery channel is arranged in the catheter body, and a leading-in port communicated with the delivery channel is arranged at the near end of the catheter body; the far end of the pushing rod is connected with the near end of the catheter body, and a filling channel is formed in the pushing rod; the far end of the catheter seat is connected with the near end of the pushing rod, and an inner cavity of the catheter seat is communicated with the filling channel; the catheter body is sleeved with the positioning balloon, and an inner cavity of the positioning balloon is communicated with the filling channel. The near end of the far-side tip end is connected with the far end of the catheter body, the far end of the catheter body is provided with a far-end opening, and the far-end opening is communicated with the conveying channel; a tip inner cavity is formed in the far-side tip, and the far end of the tip inner cavity is communicated with the conveying channel to form a combination part; the microneedles are arranged on the inner wall of the combination part in the circumferential direction of the inner wall of the combination part.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, in particular to an extended aspiration catheter and a catheter system having the catheter. Background Art

[0002] Many diseases are caused by the presence of undesirable substances in blood vessels and ventricles, most notably clots or thrombi. Clots in blood vessels can be formed by aggregates of blood cells, collagen, cholesterol, plaque, fat, calcified plaque, air bubbles, arterial tissue, proteins (such as fibrin), and / or various other debris or combinations thereof. For example, a clot can lodge in a narrowed area of a blood vessel supplying a major organ, thus resulting in a loss of oxygen-rich blood flow to surrounding tissues, leading to local cell death or microinfarction. For example, a microinfarction in the brain is an ischemic stroke, which usually results in confusion, speech disorders, paralysis, visual disturbances, balance disorders, and even death; again, in the heart, a clot can cause a myocardial infarction, i.e., a heart attack. If a clot is untreated, it poses a potentially life-threatening risk. Therefore, the presence of a clot in a blood vessel requires immediate medical intervention.

[0003] Currently, some treatments use biopharmaceutical treatment methods, in which a medicament is directly delivered into a clot through a catheter to dissolve or at least stabilize the clot until the body can clear the clot. Some treatments use mechanical devices to remove clots from a patient's blood vessels. Among them, mechanical treatment usually includes aspirating, impregnating, and compressing the clot in the blood vessel, and finally removing it through invasive surgery or non-invasive means, such as using an aspiration catheter connected to an aspiration source (such as a pump or a syringe). Different from biopharmaceuticals, the significant advantage of invasive or non-invasive mechanical treatment is that it directly attacks the clot and eliminates the vascular occlusion without affecting the non-diseased areas of the body.

[0004] Mechanical, non-invasive clot removal treatment usually involves thrombectomy, more specifically, peripheral thrombectomy and venous thrombectomy, such as deep vein thrombosis (DVT) treatment or intracranial distal aspiration.

[0005] The treatment of acute ischemic stroke using vascular aspiration thrombectomy involves an aspiration technique, which aspirates a clot into a catheter and has been proven to be as effective as mechanical thrombectomy using a stent retriever that uses a self-expanding stent-like capture device to capture and remove a thrombus. Aspiration thrombectomy has gained the favor of most neurointerventionalists due to its simple operation and cost-effectiveness.

[0006] During aspiration thrombectomy, a distal aspiration catheter is used to remove clots or emboli from blood vessels. In the first step of the procedure, the distal end of the catheter is positioned near the clot, and then a vacuum force is applied through the lumen of the catheter using a pump or a large-volume syringe. The syringe or pump uses suction to draw part of the embolus (clot or thrombus) into or into the distal portion of the extended aspiration catheter. In this case, when part of the embolus (clot or thrombus) is aspirated, it may be necessary to repeatedly pass the device to recanalize the blood vessel.

[0007] The successful clinical outcome of patients undergoing aspiration thrombectomy may depend in part on the "first-pass effect". The "first-pass effect" is defined as complete or near-complete recanalization of the affected blood vessel after the thrombectomy device passes through once by completely removing the embolus on the first attempt. However, inside the blood vessel, blood clots can undergo a process called organization, in which soft, gel-like red / purple clots are transformed into harder white clots through cross-linking of proteins such as fibrin. Over time, with the forward pressure of blood flow, the clot may also form a hard mass. Over time, hard clots form a large number of well-embedded mature clots that are less flexible and may be difficult to completely aspirate into a traditional extended aspiration catheter when static aspiration is used with an attached pump or aspiration syringe kit.

[0008] Therefore, traditional extended aspiration catheters using static suction cannot effectively remove a large number of firmly embedded clots from inside the blood vessel, especially after the aspiration catheter passes through once and the clot cannot be completely drawn into the aspiration catheter, failing to effectively achieve the effect of the "first-pass effect". And additional passes of the traditional extended aspiration catheter are required to completely remove the thrombus / embolus, seriously affecting the treatment effect. For example, Figure 1Shows the distal end of a conventional extended aspiration catheter 500 which is used to remove large clots 400 from within a blood vessel. Typically, the extended aspiration catheter 500 may have an inner diameter profile ranging from 1.3 (4F) to 4 (12F) mm. In this example, the clot 400 is lodged in the middle cerebral artery, resulting in large vessel occlusion and acute ischemic stroke. During the removal process, the distal end of the extended aspiration catheter 500 is positioned adjacent to the clot 400, and after applying a vacuum force at the proximal end of the lumen using an attached pump or aspiration syringe, the clot is partially aspirated or sucked into the lumen of the distal portion of the extended aspiration catheter 400. If the clot is firmly embedded within the extended aspiration catheter 500 and / or the diameter of the clot is greater than the diameter of the extended aspiration catheter 500, simply applying the vacuum force may not be effective in completely removing the clot 400 and achieving vessel recanalization. In other words, it is impossible to completely remove the clot 400 after the first pass of the extended aspiration catheter 500. Although a larger diameter extended aspiration catheter and / or a stronger vacuum force can be used, a larger profile extended aspiration catheter may be more difficult to navigate to reach the distal intracranial circulation and may be harmful to the vessel lumen, causing laceration or vasospasm.

[0009] In addition, during the removal process, there is also a possibility of fragmentation of well-embedded mature thrombi / emboli, which may allow the fragments to move to other areas of the blood vessel. The above risk factors associated with removing a large amount of well-embedded mature clots using a conventional extended aspiration catheter can have a negative impact on the patient's clinical outcome due to the reduced chance of the "first pass effect".

[0010] Therefore, it is necessary to provide an improved extended aspiration catheter that can effectively and completely remove firmly embedded clots within a blood vessel in one pass, enabling complete vessel recanalization and improving the patient's clinical outcome, as well as to provide a catheter system having such an extended aspiration catheter. Summary of the Utility Model

[0011] The first object of the present utility model is to provide an improved extended aspiration catheter that can effectively and completely remove firmly embedded clots within a blood vessel in one pass, enabling complete vessel recanalization and improving the patient's clinical outcome.

[0012] The second object of the present utility model is to provide a catheter system having an extended aspiration catheter that can effectively and completely remove firmly embedded clots within a blood vessel in one pass, enabling complete vessel recanalization and improving the patient's clinical outcome.

[0013] To achieve the above first object, the present utility model provides an extended aspiration catheter, comprising a catheter body, a push rod, a catheter seat, a positioning balloon, a distal tip and a micro needle. A delivery channel for delivering a medical device is provided inside the catheter body, and a delivery port communicating with the delivery channel is provided at the proximal end of the catheter body; the distal end of the push rod is connected to the proximal end of the catheter body, and a filling channel is provided inside the push rod; the distal end of the catheter seat is connected to the proximal end of the push rod, and the inner cavity of the catheter seat communicates with the filling channel; the positioning balloon is sleeved on the catheter body and is located at a position close to the proximal end of the catheter body, and the inner cavity of the positioning balloon communicates with the filling channel; the proximal end of the distal tip is connected to the distal end of the catheter body, and a distal opening is provided at the distal end of the catheter body close to the distal tip, and the distal opening communicates with the delivery channel; a tip inner cavity is provided inside the distal tip, and the proximal end of the tip inner cavity communicates with the delivery channel and forms a joint portion between the tip inner cavity and the delivery channel; a plurality of the micro needles are arranged on the inner wall of the joint portion along the circumferential direction of the inner wall of the joint portion.

[0014] Compared with the prior art, the extended aspiration catheter of the present utility model is provided with a distal tip at the distal end of the catheter body. The inner part of the distal tip is provided with a tip inner cavity communicating with the delivery channel of the catheter body, and a distal opening communicating with the delivery channel is provided at a position near the distal tip of the distal end of the catheter body. When the distal tip of the extended aspiration catheter is advanced into or near the clot in the blood vessel, static aspiration can be first applied to the delivery channel of the catheter body, so that the clot enters the delivery channel of the catheter body through the distal opening, and then cyclic aspiration is applied to the delivery channel of the catheter body. When the aspiration is started, the clot in the delivery channel moves in the proximal direction. When the aspiration stops, at least part of the clot can be migrated into the tip inner cavity of the distal tip. Since a micro-needle is provided at the joint between the tip inner cavity and the delivery channel, the micro-needle can break the clot migrated into the tip inner cavity, so that the large-sized clot can be broken into small-sized clots, which is convenient for pumping the part of the clot in the proximal direction of the delivery channel when the next aspiration is started. Therefore, the extended aspiration catheter of the present utility model can aspirate the clot in the blood vessel by means of cyclic aspiration. Among the clots entering the delivery channel of the catheter body, if the size of the clot is large and firmly embedded in the delivery channel, under the action of cyclic aspiration, the large-sized clot can first migrate into the tip inner cavity and be broken under the action of the micro-needle to become several small-sized clots, and then be pumped out in the proximal direction of the delivery channel, so as to remove the clot from the patient's body. There is no need to use an extended aspiration catheter with a larger diameter and / or apply a stronger vacuum force as in the prior art. The extended aspiration catheter of the present utility model can effectively and completely remove the clot firmly embedded in the blood vessel after passing through once, so that the blood vessel is completely recanalized and the clinical outcome of the patient is improved.

[0015] Preferably, several turns of the micro-needles are arranged on the inner wall of the tip inner cavity along the proximal direction from the joint to the tip inner cavity.

[0016] Preferably, the distal opening is arranged obliquely relative to the axis of the catheter body on the catheter body.

[0017] Preferably, a transition section is formed at the position of the distal end of the catheter body from the distal end of the distal opening to the proximal end of the distal tip.

[0018] Preferably, it further includes a guide wire tube. The guide wire tube is arranged on the outer wall of the catheter body, and a guide wire cavity for the guide wire to pass through is arranged inside the guide wire tube.

[0019] Preferably, the proximal end of the guide wire tube extends beyond the positioning balloon, and the distal end of the guide wire tube extends to the distal end of the distal tip.

[0020] Preferably, the distal end of the push rod is fixed inside the tube wall of the catheter body. A through hole is provided at a position of the push rod near the proximal end of the catheter body. The through hole communicates between the filling channel and the inner cavity of the positioning balloon.

[0021] Preferably, the proximal end of the push rod has a hollow structure, the filling channel is formed inside the hollow structure, and the distal end of the push rod has a solid structure.

[0022] To achieve the above second object, the present invention provides a catheter system, including a guiding catheter and the above-mentioned extended aspiration catheter. A guiding channel is provided inside the guiding catheter. The extended aspiration catheter is inserted into the guiding channel. The distal end of the catheter body extends out from the distal end of the guiding channel. The proximal end of the catheter body is located inside the guiding channel. The proximal end of the push rod is located outside the proximal end of the guiding channel. The guiding port communicates the delivery channel with the guiding channel. The positioning balloon abuts against the inner wall of the guiding channel after expansion.

[0023] Compared with the prior art, the catheter system of the present invention has an extended aspiration catheter. The extended aspiration catheter is provided with a distal tip at the distal end of the catheter body. A tip inner cavity communicating with the delivery channel of the catheter body is provided inside the distal tip. A distal opening communicating with the delivery channel is provided at a position of the catheter body near the distal tip. When the distal tip of the extended aspiration catheter is advanced into or near the clot in the blood vessel, static aspiration can be first applied to the guiding channel and the delivery channel, so that the clot enters the delivery channel of the catheter body through the distal opening. Then, cyclic aspiration is applied to the delivery channel of the catheter body. When the aspiration is started, the clot in the delivery channel moves towards the proximal end of the guiding channel. When the aspiration is stopped, at least part of the clot can be migrated into the tip inner cavity of the distal tip. Since a micro needle is provided at the joint between the tip inner cavity and the delivery channel, the micro needle can break the clot migrated into the tip inner cavity, so that the large-sized clot can be broken into small-sized clots, which is convenient for moving the part of the clot towards the proximal end of the guiding channel when the next aspiration is started. Therefore, the catheter system of the present invention can aspirate the clot in the blood vessel by means of cyclic aspiration. Among the clots entering the delivery channel of the catheter body, if the size of the clot is large and firmly embedded in the delivery channel, under the action of cyclic aspiration, the large-sized clot can first migrate into the tip inner cavity and be broken by the micro needle into several small-sized clots, and then be pumped out towards the proximal end of the guiding channel, so as to remove the clot from the patient's body. There is no need to use an extended aspiration catheter with a larger diameter and / or apply a stronger vacuum force as in the prior art. The catheter system of the present invention can effectively and completely remove the clot firmly embedded in the blood vessel after passing through once, so that the blood vessel is completely recanalized and the clinical outcome of the patient is improved.

[0024] Preferably, a Y-shaped connection valve is provided at the proximal end of the guiding catheter. The Y-shaped connection valve has a first interface and a second interface, the first interface and the second interface are respectively communicated with the guiding channel, the extended aspiration catheter is inserted into the first interface, and the proximal end of the push rod is located outside the Y-shaped connection valve. The second interface is used for fluid delivery or aspiration. Description of the Drawings

[0025] Figure 1 is a structural diagram of an existing extended aspiration catheter when aspirating a clot.

[0026] Figure 2 is a structural diagram of the extended aspiration catheter of the present invention.

[0027] Figure 3 is a partial structural diagram at the distal position of the extended aspiration catheter of the present invention.

[0028] Figure 4 is Figure 3 the internal structural diagram of the structure shown.

[0029] Figure 5 is Figure 4 a cross-sectional view taken along the C-C direction in

[0030] Figure 6 is Figure 3 the left view of the structure shown.

[0031] Figure 7 is Figure 2 a cross-sectional view taken along the A-A direction in

[0032] Figure 8 is Figure 7 the enlarged view at D in

[0033] Figure 9 is Figure 2 a cross-sectional view of the first embodiment taken along the B-B direction in

[0034] Figure 10 is Figure 2 a schematic cross-sectional view of the second embodiment taken along the B-B direction in

[0035] Figure 11 is Figure 2 a schematic cross-sectional view of the third embodiment taken along the B-B direction in

[0036] Figure 12 is Figure 2 a schematic cross-sectional view of the fourth embodiment taken along the B-B direction in

[0037] Figure 13It is a partial structural diagram of the extended aspiration catheter of the present utility model.

[0038] Figure 14 It is a structural diagram of the catheter system of the present utility model during aspiration operation.

[0039] Figure 15 It is Figure 14 A partial structural diagram of the catheter system shown.

[0040] Figure 16 It is a structural diagram of the extended aspiration catheter of the present utility model when the clot approaches the distal opening of the extended aspiration catheter during clot aspiration.

[0041] Figure 17 It is a structural diagram of the extended aspiration catheter of the present utility model when the clot enters the delivery channel state during clot aspiration.

[0042] Figure 18 It is a structural diagram of the extended aspiration catheter of the present utility model when the aspiration suddenly closes or decreases and the clot enters the tip lumen state during clot aspiration.

[0043] Figure 19 It is a structural diagram of the extended aspiration catheter of the present utility model when aspirating the clot again. Detailed implementation mode

[0044] In order to elaborate in detail the technical content and structural features of the present utility model, the following further explanations are made in conjunction with the implementation modes and with reference to the accompanying drawings. Among them, it should be noted that in the above description and the following description, "proximal end" generally refers to the end of the medical device that is closer to the operator during normal operation, and "distal end" generally refers to the end of the medical device that first enters the patient's body during normal operation.

[0045] The terms clot, thrombus, and embolus may be used interchangeably in this specification. Generally, these terms represent a mass or connective group of blood cells, collagen, cholesterol, plaque, fat, calcified plaque, air bubbles, arterial tissue, protein aggregates (such as fibrin), and / or various other debris or combinations thereof.

[0046] Please refer to Figures 2 to 15, the catheter system 200 of the present utility model includes a guiding catheter 201 and an extended aspiration catheter 100. Among them, the extended aspiration catheter 100 includes a catheter body 1, a push rod 2, a catheter hub 3, a positioning balloon 4, a distal tip 7 and a micro needle 8. A delivery channel 11 for delivering medical devices is provided inside the catheter body 1, and an inlet 12 communicating with the delivery channel 11 is provided at the proximal end of the catheter body 1; the distal end of the push rod 2 is connected to the proximal end of the catheter body 1, and a filling channel 21 is provided inside the push rod 2; the distal end of the catheter hub 3 is connected to the proximal end of the push rod 2, and the inner cavity of the catheter hub 3 communicates with the filling channel 21; the positioning balloon 4 is sleeved on the catheter body 1 and is located near the proximal end of the catheter body 1, and the inner cavity of the positioning balloon 4 communicates with the filling channel 21; the proximal end of the distal tip 7 is connected to the distal end of the catheter body 1, and a distal opening 16 is provided at the distal end of the catheter body 1 near the distal tip 7, and the distal opening 16 communicates with the delivery channel 11; a tip inner cavity 71 is provided inside the distal tip 7, and the proximal end of the tip inner cavity 71 communicates with the delivery channel 11 and forms a joint 72 between the tip inner cavity 71 and the delivery channel 11; a plurality of micro needles 8 are arranged on the inner wall of the joint 72 along the circumferential direction of the inner wall of the joint 72.

[0047] A guiding channel 201a is provided inside the guiding catheter 201. The extended aspiration catheter 100 is inserted into the guiding channel 201a, and the distal end of the catheter body 1 passes out from the distal end of the guiding channel 201a. The proximal end of the catheter body 1 is located inside the guiding channel 201a, the proximal end of the push rod 2 is located outside the proximal end of the guiding channel 201a, the inlet 12 connects the delivery channel 11 with the guiding channel 201a, and the positioning balloon 4 abuts against the inner wall of the guiding channel 201a after expansion.

[0048] By providing a distal tip 7 at the distal end of the catheter body 1, an inner cavity 71 communicating with the delivery channel 11 of the catheter body 1 is provided inside the distal tip 7, and a distal opening 16 communicating with the delivery channel 11 is provided at a position near the distal tip 7 at the distal end of the catheter body 1. When the distal tip 7 of the extended aspiration catheter 100 is advanced into or near the blood clot 300 in the blood vessel, static aspiration can be first applied to the delivery channel 11 of the catheter body 1, so that the blood clot 300 enters the delivery channel 11 of the catheter body 1 through the distal opening 16, and then cyclic aspiration is applied to the delivery channel 11 of the catheter body 1. When the aspiration is started, the blood clot 300 in the delivery channel 11 moves in the proximal direction. When the aspiration is stopped, at least part of the blood clot 300 can be migrated into the inner cavity 71 of the distal tip 7. Since a micro needle 8 is provided at the junction between the inner cavity 71 and the delivery channel 11, the micro needle 8 can break up the blood clot 300 migrated into the inner cavity 71, so that the large-sized blood clot 300 can be broken into small-sized blood clots 300, which is convenient for pumping the part of the blood clot 300 in the proximal direction of the delivery channel 11 when the next aspiration is started, and then discharging it through the guiding channel 201a.

[0049] The distal tip 7 can be relatively smooth or can have a shape configured to assist in penetrating or softening the blood clot, such as a helical shape.

[0050] The inner cavity 71 of the tip can extend the entire length of the distal tip 7 or only along a part of its length. The inner cavity 71 is shown as having a relatively uniform cylindrical or conical shape, but other shapes, such as an elliptical cross-sectional shape, are also possible. In addition, the inner surface of the inner cavity 71 can have protrusions, rings, corrugations, hooks, pins or similar features.

[0051] Please refer to Figure 4 and Figure 5 In one embodiment, a plurality of turns of micro needles 8 are arranged on the inner wall of the inner cavity 71 along the proximal direction from the junction 72 to the inner cavity 71 of the tip. By arranging a plurality of turns of micro needles 8 along the proximal direction from the junction 72 to the inner cavity 71 of the tip, the blood clot 300 can be broken by the micro needles 8 multiple times during the process of moving in the distal direction of the inner cavity 71 of the tip, making the blood clot 300 more fully broken.

[0052] Please refer to Figure 3 and Figure 4, in one embodiment, the distal opening 16 is disposed on the catheter body 1 in an inclined manner relative to the axis of the catheter body 1. Specifically, the distal opening 16 is beveled or formed in a plane that forms an angle of approximately 45 degrees with respect to the axis of the extended aspiration catheter 100. The distal end of the catheter body 1 forms a transition section 17 at the position from the distal end of the distal opening 16 to the proximal end of the distal tip 7. The transition section 17 can form a surface having an angle similar to that of the distal opening 16 or a larger or smaller angle. Other angles of the distal opening 16 are also possible, for example, 90° (i.e., perpendicular), 315°, 15°, 25°, 75°, or any angle within 10% of these values.

[0053] The inclined angle of the distal opening 16 can help aspirate a larger clot 300 into the delivery channel 11. An angle that is inclined inwardly toward the center of the cross-section of the extended aspiration catheter 100 (such as 315 degrees) can be at least partially parallel to the distal tip 7 and extend oppositely to the distal tip 7, and thus can accommodate the clot 300 on the opposite side.

[0054] Please refer to Figure 3 , Figure 4 and Figure 14 , in one embodiment, the catheter system 200 of the present utility model further includes a guide wire 202, and the extended aspiration catheter 100 further includes a guide wire tube 5. The guide wire tube 5 is disposed on the outer wall of the catheter body 1, and a guide wire cavity 51 for the guide wire 202 to pass through is provided inside the guide wire tube 5. The guide wire 202 can movably pass through the guiding channel 201a and the guide wire cavity 51.

[0055] Please continue to refer to Figure 3 , Figure 4 and Figure 14 , in one embodiment, the proximal end of the guide wire tube 5 extends beyond the positioning balloon 4, and the distal end of the guide wire tube 5 extends to the distal end of the distal tip 7, so as to ensure that the guide wire 202 is located inside the guide wire tube 5 at the position corresponding to the positioning balloon 4 to the position corresponding to the distal end of the catheter body 1, avoid forming an angle between the guide wire 202 and the outside of the catheter body 1, and further ensure the smoothness of pushing the catheter body 1.

[0056] Please refer to Figure 14 , in one embodiment, the guide wire tube 5 is located at a position close to the pushing rod 2.

[0057] Please refer to Figure 9 , in one embodiment, the catheter body 1 includes an inner layer 13, an intermediate reinforcing layer 14, and an outer layer 15 which are arranged in sequence from the inside to the outside. The catheter body 1 is a three-layer composite structure, which can provide strong support, pressure resistance, and anti-flexure properties.

[0058] In one embodiment, the material of the inner layer 13 is polytetrafluoroethylene or linear low-density polyethylene, thereby providing a lower friction for other instruments to pass through the delivery channel 11 located within the inner layer 13; the intermediate reinforcing layer 14 is a stainless steel braided mesh layer or a spring layer, enabling the catheter body 1 to have strong negative pressure resistance and strong support, so as to improve the anti-folding property and torsional controllability of the catheter body 1; the material of the outer layer 15 is one or a mixture of polyether block polyamide, nylon, and polyurethane elastomer, and the outer surface has a smoother appearance and feel, fully protecting the blood vessel and avoiding the generation of clots 300, dissections, etc.

[0059] In one embodiment, the softness and hardness of the outer layer 15 gradually decrease from the proximal end to the distal end of the catheter body 1. This makes the catheter body 1 not appear obtrusive, better meeting the requirements for pushing the catheter body 1 within the human blood vessel. It can not only enable doctors to operate more precisely and conveniently but also reduce the pain of patients during the operation. Further, the outer layer 15 is also coated with a hydrophilic layer, and the head end of the catheter body 1 is soft and non-invasive. This design ensures that the catheter body 1 has good support, controllability, and lubricity.

[0060] Please refer to Figures 10 to 12 , in other embodiments, the catheter body 1 and the guide wire tube 5 are integrally provided, such that the guide wire cavity 51 and the delivery channel 11 are integrally provided. The guide wire cavity 51 is preferably provided within the catheter body 1, and the cross-sectional shape of the delivery channel 11 can be deformed in various ways, for example Figures 10 to 12 as shown, but not limited thereto.

[0061] Please refer to Figure 2 , Figure 7 , Figure 8 and Figure 13 , in one embodiment, the distal end of the push rod 2 is fixed within the tube wall of the catheter body 1. A through hole 22 is provided at a position of the push rod 2 close to the proximal end of the catheter body 1, and the through hole 22 communicates between the filling channel 21 and the inner cavity of the positioning balloon 4. The inner cavity of the catheter hub 3, the filling channel 21 of the push rod 2, and the inner cavity of the positioning balloon 4 communicate with each other and form a single cavity channel. Doctors can connect media such as injection fluids at the catheter hub 3, and the fluids and other media can enter the positioning balloon 4 through the inner cavity of the catheter hub 3, the filling channel 21 of the push rod 2, and the through hole 22, thereby pressurizing the positioning balloon 4, enabling the positioning balloon 4 to quickly anchor within the guiding channel 201a of the guiding catheter 201 and perform blockage. Also, since the distal end of the push rod 2 is fixed within the tube wall of the catheter body 1, the push rod 2 can be hidden in the middle of the material of the catheter body 1, such that the push rod 2 does not cause damage to the blood vessel. Specifically, a plurality of through holes 22 are provided on the push rod 2, and the through holes 22 are distributed at the middle position of the balloon.

[0062] Please refer to Figure 13, in one embodiment, the proximal end of the push rod 2 has a hollow structure 23, the filling channel 21 is formed inside the hollow structure 23, and the distal end of the push rod 2 has a solid structure 24. By setting the distal end of the push rod 2 as the solid structure 24, the pushing force can be better transmitted. Further, the outer diameter of the hollow structure 23 is larger than the outer diameter of the solid structure 24, thereby ensuring the strength of the push rod 2 at the position of the hollow structure 23.

[0063] During the interventional treatment process, the operator can directly hold the catheter hub 3 to smoothly advance the catheter body 1 in the human body. The push rod 2 provides good supporting force and pushing force for the extended aspiration catheter 100 to ensure the smooth progress of the operation. Among them, the push rod 2 can be made of stainless steel, and the outer surface is polished to improve the safety of interventional treatment.

[0064] Please refer to Figure 2 , Figure 13 and Figure 14 , in one embodiment, the inlet 12 of the catheter body 1 has an inclined opening structure, which can make the extended aspiration catheter 100 of the present invention have better pushing property transmission.

[0065] The inlet 12 can serve as a channel for instruments to enter and exit, and can also serve as a channel for aspirating the clot 300. For example, an external catheter or stent can enter the delivery channel 11 of the catheter body 1 from the inlet 12 and move through it to the distal end of the catheter body 1. In this way, the extended aspiration catheter 100 can be used as a rapid exchange catheter, thereby realizing the rapid exchange of instruments; for another example, the inlet 12 can also be connected to a syringe through a guiding catheter 201 to facilitate the aspiration of the clot 300 through the syringe.

[0066] Please refer to Figure 2 and Figure 7 , in one embodiment, the positioning balloon 4 is vacuum-flattened and adhered to the outer layer 15 of the catheter body 1. The distal end of the positioning balloon 4 is tightly welded or adhered to the outer layer 15 of the catheter body 1 to form a sealed end; the proximal end of the positioning balloon 4 is tightly welded to the outer layer 15 of the catheter and the distal end of the push rod 2. The welding or adhesion joints at both ends of the entire positioning balloon 4 have a smooth transition, without obvious concave and convex feeling, and it is more smooth and has low resistance for instruments to enter other channels. Specifically, the positioning balloon 4 can be a compliant balloon. Here, the compliant balloon means that after the positioning balloon 4 is expanded to a predetermined diameter, its diameter and volume can continuously increase with the increase of the filling pressure. The positioning balloon 4 can be made of nylon, polyethylene, polyurethane or polyethylene terephthalate materials.

[0067] Please refer to Figure 2 and Figure 13, in one embodiment, a visualization element 6 is provided at the outer layer 15 of the catheter body 1 near the positioning balloon 4. Further, the visualization element 6 may also be provided at the distal opening 16 of the catheter body 1 or along the edge of the distal opening 16. However, this is not limiting. In other embodiments, for example, the visualization element 6 may also be provided on the distal tip 7. During the angiography operation, the visualization element 6 can display a dark shadow to provide position information for the operator. The visualization element 6 can be made of an X-ray impermeable visualization material, and the visualization material is one or more of gold, tungsten, platinum, and platinum-iridium alloy. The visualization element 6 can be a visualization ring, or a cylindrical helical visualization coil, or a visualization coating coated on the side wall of the catheter body 1. Specifically, the visualization element 6 is preferably a visualization ring, which can help the operator quickly capture the positions of the catheter body 1 and the balloon.

[0068] Please refer to Figure 15 , in one embodiment, a Y-shaped connection valve 203 is provided at the proximal end of the guiding catheter 201. The Y-shaped connection valve 203 has a first interface 203a and a second interface 203b. The first interface 203a and the second interface 203b are respectively communicated with the guiding channel 201a. The guide wire 202 and the extended aspiration catheter 100 are both inserted into the first interface 203a, and the proximal end of the push rod 2 is located outside the Y-shaped connection valve 203. The second interface 203b is used for fluid delivery or aspiration.

[0069] In one embodiment, after the extended aspiration catheter 100 of the present utility model completes the anchoring operation, a contrast agent or other fluid medium can be injected through the Y-shaped connection valve on the guiding catheter 201. The medium can flow along the guiding channel 201a of the guiding catheter 201 into the delivery channel 11 of the catheter body 1 of the extended aspiration catheter 100 for super-selective angiography or other targeted treatments.

[0070] In one embodiment, after the extended aspiration catheter 100 of the present utility model completes the anchoring operation, relevant aspiration instruments can be used to aspirate blood clots 300, calcified plaques, etc. from the blood vessel through the Y-shaped connection valve on the guiding catheter 201. The blood clot 300 or calcified plaque, etc. can flow back along the delivery channel 11 of the catheter body 1 of the extended aspiration catheter 100 into the guiding channel 201a of the guiding catheter 201 under the action of negative pressure and finally be drawn out of the body.

[0071] The extended aspiration catheter 100 of this specification can be used together with static aspiration (i.e., constant aspiration vacuum force), cyclic suction force (i.e., suction force that cycles between a higher and a lower / no suction force), or a combination of both to completely remove the blood clot 300 and recanalize the blood vessel where the blood clot 300 is located.

[0072] In the case of cyclic aspiration, a phenomenon commonly known as the "water hammer effect" occurs. Generally, the water hammer effect refers to the pressure fluctuations or high-pressure shock waves in a liquid pipeline that propagate through the pipeline system when the fluid in motion is forced to change direction or suddenly stop. In the context of the present utility model, such pressure fluctuations or shock waves can cause the fluid in the delivery channel 11 of the catheter body 1 to move in the direction opposite to aspiration within a very short time. In other words, during aspiration, the fluid will move in the proximal direction of the delivery channel 11, and when the aspiration suddenly stops or decreases, the pressure shock wave can push the clot 300 (and potentially some fluid) back in the distal direction of the delivery channel 11.

[0073] As Figures 16 to 19 shown, aspiration is initiated to move the clot 300 proximally until the clot 300 is at least partially moved into the distal opening 16. When the aspiration is suddenly closed or reduced, a pressure shock wave is generated according to the arrows in the figure, which pushes the clot 300 into the tip lumen 71 of the distal tip. The aspiration cycle to achieve the water hammer effect may only require one time, or it may be performed multiple times (e.g., 2, 3, 4, 5, 6, 7, 8 times or more) to position the clot 300 at the desired position in the tip lumen 71. Cyclic aspiration generally may include relatively rapidly and continuously increasing and decreasing the aspiration or vacuum level. For example, the aspiration level can aspirate and then pause aspiration, or the aspiration can vary between a weaker and a stronger level. In another example, the cycle of aspiration can occur at intervals from 0.5 seconds to 3 seconds (e.g., intervals of 0.5, 1, 1.5, 2, 2.5 or 3, and combinations thereof). This position of the clot 300 in the tip lumen 71 can capture the clot 300 more firmly, and thus can better prevent the clot 300 from slipping out of the extended aspiration catheter 100 when removed from the patient's body.

[0074] It should be noted that, at least for the purpose of moving the clot 300 into the tip lumen 71, an alternative to this water hammer pressure wave can be achieved by applying an initial proximal aspiration for a period, followed by applying a short-term distal pressure in the distal direction (i.e., reverse flow within the delivery channel 11 of the catheter body 1).

[0075] Combined Figures 2 to 19 , taking the example of entering a small blood vessel to aspirate the clot 300, the specific working principle of the catheter system 200 of the present utility model is as follows:

[0076] Entering the target area: The clot 300 is in a small blood vessel. The guiding catheter 201 is delivered to a larger blood vessel near the small blood vessel, and the guide wire 202 is delivered to the clot 300 in the small blood vessel through the first interface 203a of the Y-shaped connection valve 203 at the proximal end of the guiding catheter 201. The extended aspiration catheter 100 is delivered along the guide wire 202. The extended aspiration catheter 100 extends from the first interface 203a of the Y-shaped connection valve 203 at the proximal end of the guiding catheter 201 into the guiding catheter 201. The distal end of the catheter body 1 of the extended aspiration catheter 100 protrudes from the distal end of the guiding catheter 201, and the distal tip 7 is located in or near the clot 300. The proximal end of the catheter body 1 is located within the guiding channel 201a, one end of the push rod 2 is located within the guiding channel 201a, and the other end of the push rod 2 protrudes from the first interface 203a of the Y-shaped connection valve 203. The catheter hub 3 is located outside the Y-shaped connection valve 203. Under the guidance of the guide wire 202, the catheter body 1 enters the designated position. Since the push rod 2 is contained within the catheter body 1, force can be exerted by the push rod 2, making it easier for the guiding catheter 201 to enter the branch blood vessels and narrow blood vessels.

[0077] Establishing a transmission channel: The positioning balloon 4 is filled through the lumen of the catheter hub 3 and the filling channel 21 within the push rod 2. After the positioning balloon 4 expands, it is anchored within the guiding channel 201a. The positioning balloon 4 seals the gap between the guiding catheter 201 and the catheter body 1, and the guiding channel 201a communicates with the catheter lumen.

[0078] External aspirator aspirates the clot 300 and plaque: The first interface 203a where the push rod 2 protrudes from the Y-shaped connection valve 203 of the guiding catheter 201 is blocked, and an aspirator is connected to the second interface 203b of the Y-shaped connection valve 203 to aspirate the clot 300 and plaque at the distal end of the aspiration catheter body 1. The clot 300 or calcified plaque, etc., flows back along the delivery channel 11 of the catheter body 1 to the guiding channel 201a under the action of negative pressure until it is drawn out of the body. Among them, static aspiration can be first applied to the delivery channel 11 of the catheter body 1 to enable the clot 300 to enter the delivery channel 11 of the catheter body 1 through the distal opening 16, and then cyclic aspiration can be applied to the delivery channel 11 of the catheter body 1. When the aspiration is started, the clot 300 within the delivery channel 11 moves in the proximal direction. When the aspiration stops, at least part of the clot 300 can be migrated to the tip lumen 71 of the distal tip 7. Since the micro needle 8 is provided at the junction between the tip lumen 71 and the delivery channel 11, the micro needle 8 can break up the clot 300 migrated to the tip lumen 71, so that the large-sized clot 300 can be broken into small-sized clots 300. Therefore, under the action of cyclic aspiration, the clot 300 can first migrate to the tip lumen 71 and be broken by the micro needle 8 to become several small-sized clots 300, and then be pumped out in the proximal direction of the delivery channel 11, thus removing the clot 300 from the patient's body.

[0079] Withdrawal of the guide wire 202 (or the extended aspiration catheter 100): Use the pressure pump to aspirate the medium in the positioning balloon 4 in the negative pressure state. Under fluoroscopy, confirm that the positioning balloon 4 is deflated and there is no residual medium, and then withdraw the guide wire 202 (or the extended aspiration catheter 100) as a whole until it is withdrawn from the body.

[0080] In summary, the catheter system 200 of the present utility model has an extended aspiration catheter 100, which can aspirate clots in blood vessels by means of cyclic aspiration. Among the clots 300 entering the delivery channel 11 of the catheter body 1, if the size of the clot 300 is large and firmly embedded in the delivery channel 11, under the action of cyclic aspiration, the large-sized clot 300 can first migrate toward the tip lumen 71 and be broken under the action of the micro needle 8 into several small-sized clots 300, and then be aspirated and sent out toward the proximal direction of the delivery channel, so as to remove the clot 300 from the patient's body. There is no need to use an extended aspiration catheter 100 with a larger diameter and / or apply a stronger vacuum force as in the prior art. The extended aspiration catheter 100 of the present utility model can effectively and completely remove the firmly embedded clot 300 in the blood vessel after passing through once, enabling the blood vessel to be completely recanalized and improving the clinical outcome of the patient. Secondly, by providing a guide wire tube 5 on the outer wall of the catheter body 1, the guide wire 202 can pass through the guide wire lumen 51 of the guide wire tube 5 without occupying the area of the delivery channel 11 of the catheter body 1, making the aspiration path for aspiration through the guiding channel 201a and the delivery channel 11 smooth, with a relatively large effective aspiration area, which can avoid the influence of the guide wire 202 on the effective aspiration area of the lumen and improve the aspiration effect. At the same time, the guide wire 202 passing through the guide wire lumen 51 can also guide and position the catheter body 1 to ensure that the extended aspiration catheter 100 can be accurately delivered to the target area. In addition, since the guide wire 202 does not occupy the area of the delivery channel 11 of the catheter body 1, the effective aspiration area is relatively large, and the aspiration ability for large clots 300 is better, reducing complications. Moreover, the extended aspiration catheter 100 of the present utility model can not only be inserted deeply into the blood vessel as a guiding instrument to a farther position, but also realize the functions of aspirating clots 300 and plaques, reducing clot 300 events caused by clot 300 aspiration, reducing the exchange between instruments, and improving the surgical efficiency.

[0081] The above-disclosed are only the preferred examples of the present utility model, and the scope of the rights of the present utility model cannot be limited thereby. Therefore, all equivalent changes made according to the claims of the present utility model fall within the scope covered by the present utility model.

Claims

1. An extended suction catheter, characterized in that: include: A catheter body, wherein a delivery channel for delivering medical devices is provided in the catheter body, and a proximal end of the catheter body is provided with an introduction port communicating with the delivery channel; A push rod, the distal end of which is connected to the proximal end of the catheter body, and a filling channel is provided inside the push rod; A catheter seat, the distal end of which is connected to the proximal end of the push rod, and the inner cavity of which is in communication with the filling channel; A positioning balloon, which is sleeved on the catheter body and located near the proximal end of the catheter body, and the inner cavity of the positioning balloon is communicated with the filling channel; A distal tip, the proximal end of which is connected to the distal end of the catheter body, the distal end of the catheter body is provided with a distal opening at a position close to the distal tip, and the distal opening is communicated with the delivery channel; a tip inner cavity is provided inside the distal tip, the proximal end of the tip inner cavity is communicated with the delivery channel and forms a junction between the tip inner cavity and the delivery channel; Microneedles, a plurality of the microneedles are arranged on the inner wall of the combining portion along the circumferential direction of the inner wall of the combining portion.

2. The extended suction catheter according to claim 1, characterized in that A plurality of circles of the microneedles are arranged on the inner wall of the tip cavity along the proximal direction from the joint to the tip cavity.

3. The extended suction catheter according to claim 1, characterized in that The distal opening is arranged on the catheter body in an inclined manner relative to the axis of the catheter body.

4. The extended suction catheter according to claim 1, characterized in that The distal end of the catheter body forms a transition section at a position from the distal end of the distal end opening to the proximal end of the distal tip.

5. The extended suction catheter according to claim 1, characterized in that It also includes a guide wire tube, which is arranged on the outer wall of the catheter body, and a guide wire cavity is arranged in the guide wire tube for the guide wire to pass through.

6. The extended suction catheter according to claim 5, characterized in that The proximal end of the guide wire tube exceeds the positioning balloon, and the distal end of the guide wire tube extends to the distal end of the distal tip.

7. The extended suction catheter according to claim 1, characterized in that The distal end of the push rod is fixed in the tube wall of the catheter body. A through hole is provided at a position of the push rod close to the proximal end of the catheter body. The through hole is connected between the filling channel and the inner cavity of the positioning balloon.

8. The extended suction catheter according to claim 1, characterized in that The proximal end of the push rod is a hollow structure, the filling channel is formed in the hollow structure, and the distal end of the push rod is a solid structure.

9. A catheter system, characterized in that: It includes a guiding catheter and an extended suction catheter as described in any one of claims 1 to 8, wherein a guiding channel is provided in the guiding catheter, the extended suction catheter is inserted in the guiding channel, and the distal end of the catheter body passes through the distal end of the guiding channel, the proximal end of the catheter body is located in the guiding channel, the proximal end of the push rod is located outside the proximal end of the guiding channel, the introduction port connects the delivery channel with the guiding channel, and the positioning balloon abuts against the inner wall of the guiding channel after expansion.

10. The catheter system according to claim 9, characterized in that A Y-shaped connecting valve is provided at the proximal end of the guiding catheter, and the Y-shaped connecting valve has a first interface and a second interface, the first interface and the second interface are respectively connected to the guiding channel, the extended suction catheter is inserted into the first interface, and the proximal end of the push rod is located on the outside of the Y-shaped connecting valve, and the second interface is used for fluid delivery or suction.

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