Bending-adjustable suction catheter system for thrombus cutting

Abstract

The embodiment of the utility model provides an adjustable bent suction catheter system for thrombus cutting, and relates to the field of medical instruments. The adjustable bending suction catheter system for thrombus cutting comprises an adjustable bending suction catheter and a thrombus cutter, the adjustable bending suction catheter comprises a suction tube body and a bending adjusting mechanism, the bending adjusting mechanism is connected with the suction tube body, the bending adjusting mechanism is used for controlling the bending degree of the far end of the suction tube body, and the thrombus cutter is movably arranged on the suction tube body. According to the thrombus cutting bendable suction catheter system, the treatment effect and operation efficiency of intervention type thrombus suction treatment can be improved, repetition and complexity of the operation process of medical staff are reduced, pain and treatment cost of a patient in the operation process are reduced, and postoperative complications such as vascular injury and perforation in the operation process are reduced.

Description

TECHNICAL FIELD

[0001] The utility model relates to the field of medical apparatus and instruments, and particularly relates to a thrombus cutting adjustable bending suction catheter system. BACKGROUND

[0002] The thrombus suction catheter is composed of a catheter and a suction system, and the catheter is generally made of soft and flexible material and can enter the inside of the vein or artery of a patient. The suction system is connected to the outside world and can generate negative pressure at the proximal end of the catheter to suck out foreign matter in the blood vessel. The thrombus suction catheter is simple in structure and is the most widely used in the prior art. For thrombus that cannot be suctioned, a thrombus stent is often used to wrap the thrombus and pull the thrombus into the catheter to discharge it from the body, thereby achieving the treatment of thrombus.

[0003] In the prior art, the catheter head of the thrombus suction catheter is a straight pipe with certain flexibility, which is equivalent to a straight head of the catheter. The catheter cannot autonomously select the blood vessel to enter and often needs to be guided by a guide wire or pre-shaped at the catheter head to enter the correct blood vessel. When the catheter is pushed in the blood vessel, the catheter with a straight head will generate a large resistance in the tortuous blood vessel. At this time, if the catheter is continuously pushed, the inner wall of the blood vessel may be damaged or a dissection may occur, and the catheter may be bent, which seriously affects the success rate of the operation.

[0004] In addition, in the process of suctioning the thrombus, due to the formation characteristics of the thrombus, the formed thrombus has a short formation time, a small volume, is located in the middle of the blood vessel, and is not adhered to the blood vessel wall. The suction process of the thrombus is relatively smooth. The deposition thrombus, atherosclerotic plaque, a red blood cell complex reinforced clot thrombus, and part of the thrombus with a large volume and a large load in the blood vessel are difficult to suction. The thrombus blocks the catheter head of the thrombus suction catheter, and the instrument needs to be withdrawn to remove the blockage. This requires the thrombus to be repeatedly transported into the catheter and suctioned multiple times, which increases the difficulty of the operation, increases the burden of the patient, and may cause damage to the blood vessel, such as dissection and perforation. The more the suction is repeated, the greater the damage to the blood vessel. Utility model content

[0005] The utility model provides a kind of thrombus cutting adjustable bending suction catheter system, which can improve the treatment effect and operation efficiency of interventional thrombus suction treatment, reduce the repetition and tediousness of medical staff in the operation process, reduce the pain and treatment cost of patient in the operation process, and reduce the vascular injury, perforation and other postoperative complications in the operation process.

[0006] The embodiments of the utility model can be implemented as follows:

[0007] The utility model provides a kind of thrombus cutting adjustable bending suction catheter system, comprising:

[0008] An adjustable bending suction catheter, comprising a suction tube body and a bending adjusting mechanism connected with the suction tube body, the bending adjusting mechanism being used to control the bending degree of the distal end of the suction tube body; and

[0009] A thrombus cutter movably arranged in the suction tube body to be received in or extended out of the suction tube body.

[0010] In an optional embodiment, the bending adjusting mechanism comprises a tube connector, a bending guide wire and a handle, the handle being rotatably connected with the tube connector, the distal end of the bending guide wire being connected with the distal end of the suction tube body, the tube connector being connected with the proximal end of the suction tube body, the handle having an adjusting wheel connected with the bending guide wire, the adjusting wheel being used to tighten or loosen the bending guide wire to control the bending degree of the distal end of the suction tube body.

[0011] The handle is provided with an instrument channel, the proximal end of the suction tube body is arranged in the tube connector and located in the instrument channel.

[0012] In an optional embodiment, the suction tube body comprises a head end, a bending part and a main tube body part connected in sequence, the proximal end of the main tube body part is arranged in the tube connector and located in the instrument channel, the adjusting wheel is used to tighten or loosen the bending guide wire to control the bending degree of the bending part.

[0013] The head end is provided with a visible element, the bending guide wire passes through the main tube body part and the bending part in sequence, and the distal end of the head end is connected with the distal end of the bending guide wire, the bending part is provided with a first spiral structure.

[0014] In an optional embodiment, the thrombus cutting adjustable bending suction catheter system further comprises a microcatheter, the microcatheter being movably arranged in the suction tube body, the thrombus cutter being movably arranged in the microcatheter to be received in or extended out of the microcatheter.

[0015] In an optional embodiment, the thrombus cutting adjustable bending suction catheter system further comprises a T-shaped hemostatic valve, the T-shaped hemostatic valve comprising a first male luer connector, a first valve body, a first hemostatic connector and a connecting tube in communication with the first valve body connected in sequence.

[0016] The first male luer connector is connected with the proximal end of the handle, and the first male luer connector is used to communicate with the suction tube body, the microcatheter passes through the first hemostatic connector, the first valve body, the first male luer connector and the suction tube body in sequence.

[0017] In an optional embodiment, the T-shaped hemostatic valve further comprises an extension tube, which is in communication with the connecting tube.

[0018] In an optional embodiment, the thrombus cutting adjustable bending suction catheter system further comprises a Y-shaped valve, which comprises a second male Luer connector, a second valve body and a second hemostatic connector connected in sequence.

[0019] The second male Luer connector is in communication with the proximal end of the microcatheter, and the thrombus cutter passes through the second hemostatic connector, the second valve body, the second male Luer connector and the microcatheter in sequence.

[0020] In an optional embodiment, the thrombus cutter comprises a flexible head, a cutting member, a core wire and a control rod, the distal end of the flexible head is connected with the core wire, and the distal end of the cutting member is connected with the proximal end of the flexible head.

[0021] The distal end of the control rod is connected with the proximal end of the cutting member, and the control rod is slidably sleeved on the core wire, so that the cutting member is retracted or expanded.

[0022] In an optional embodiment, the peripheral wall of the control rod has a second spiral structure.

[0023] In an optional embodiment, the thrombus cutter further comprises a control rod seat, which is connected with the control rod.

[0024] The thrombus cutting adjustable bending suction catheter system has the following advantages, for example:

[0025] The utility model provides a kind of thrombus cutting adjustable bending suction catheter system, the thrombus cutting adjustable bending suction catheter system includes adjustable bending suction catheter and thrombus cutter, adjustable bending suction catheter includes suction pipe body and bending mechanism, bending mechanism and suction pipe body are connected, bending mechanism is used to control the bending degree of suction pipe body far end, thrombus cutter is movably arranged in suction pipe body, to receive or extend suction pipe body, since bending mechanism is used to control the bending degree of suction pipe body far end, adjustable bending suction catheter can be adjusted along the bending of blood vessel in tortuous part of blood vessel, so that suction pipe body can pass through tortuous blood vessel smoothly, reach thrombus part, even can be superselected into large-angle blood vessel or branch blood vessel, greatly strengthen the blood vessel compliance of suction catheter, reduce the bending probability of suction pipe body, increase operation success rate, in addition, the thrombus cutting adjustable bending suction catheter system includes thrombus cutter, by releasing thrombus cutter, cut large load thrombus, when suction, suction catheter will not be blocked due to thrombus block, reduce the repeatability of operation, improve the efficiency and operation effect of operation. Therefore, the thrombus cutting adjustable bending suction catheter system can improve the treatment effect and operation efficiency of interventional thrombus suction treatment, reduce the repetition and tediousness of medical staff operation process, alleviate the pain and treatment cost of patient operation process, reduce vascular injury, perforation and other postoperative complications in operation process. BRIEF DESCRIPTION OF DRAWINGS

[0026] In order to more clearly illustrate the technical scheme of the embodiments of the utility model, the following will be briefly introduced to the drawing needed to be used in the embodiment, should understand, the following drawing only shows some embodiments of the utility model, therefore should not be regarded as the limitation to the scope, for ordinary skilled person in the art comes, under the premise of not paying the creative labor, can also obtain other related drawings according to these drawings.

[0027] Figure 1 It is the schematic diagram of the thrombus cutting adjustable bending suction catheter system provided in the embodiment of the utility model;

[0028] Figure 2 It is the first section view perspective schematic diagram of part structure of the thrombus cutting adjustable bending suction catheter system provided in the embodiment of the utility model;

[0029] Figure 3 It is the second section view perspective schematic diagram of part structure of the thrombus cutting adjustable bending suction catheter system provided in the embodiment of the utility model;

[0030] Figure 4 It is the third section view perspective schematic diagram of part structure of the thrombus cutting adjustable bending suction catheter system provided in the embodiment of the utility model;

[0031] Figure 5Part structure section view of the suction pipe body provided in the embodiment of the utility model;

[0032] Figure 6 Sectional view of the suction pipe body provided in the embodiment of the utility model;

[0033] Figure 7 Schematic view of the T type hemostatic valve provided in the embodiment of the utility model;

[0034] Figure 8 Schematic view of the Y type valve provided in the embodiment of the utility model;

[0035] Figure 9 Schematic view of the micro catheter provided in the embodiment of the utility model;

[0036] Figure 10 Schematic view of the thrombus cutter provided in the embodiment of the utility model;

[0037] Figure 11 Sectional view of the thrombus cutter provided in the embodiment of the utility model;

[0038] Figure 12 Schematic view of the cutting member natural expansion state provided in the embodiment of the utility model;

[0039] Figure 13 Schematic view of the cutting member complete expansion state provided in the embodiment of the utility model;

[0040] Figure 14 Schematic view of the cutting member unexpanded state provided in the embodiment of the utility model.

[0041] Icon: 100 - adjustable bending suction catheter; 110 - suction tube body; 1101 - first guide wire channel; 1102 - second guide wire channel; 111 - head end; 1111 - anchor bending guide wire structure; 112 - bending portion; 113 - main tube body portion; 120 - bending mechanism; 121 - tube body connector; 122 - first bending guide wire; 123 - second bending guide wire; 124 - handle; 1241 - adjusting wheel; 1242 - instrument channel; 1243 - standard luer connector; 200 - thrombectomy device; 210 - flexible head; 220 - cutting member; 230 - core wire; 240 - control rod; 250 - control rod seat; 300 - microcatheter; 310 - microcatheter head; 320 - microcatheter tube body; 330 - microcatheter standard female luer connector; 400 - T-shaped hemostasis valve; 410 - first male luer connector; 420 - first valve body; 430 - first hemostasis connector; 440 - connecting tube; 450 - extension tube; 460 - female luer connector; 500 - Y-shaped valve; 510 - second male luer connector; 520 - second valve body; 521 - main body structure; 522 - second standard female luer connector; 530 - second hemostasis connector. DETAILED DESCRIPTION

[0042] In order to make the objects, technical solutions, and advantages of the embodiments of the present application clearer, the following will be combined with the drawings of the embodiments of the present application to make a clear and complete description of the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments of the present application. The components of the embodiments of the present application described and shown in the drawings can be arranged and designed in various different configurations.

[0043] Therefore, the following detailed description of the embodiments of the present application provided in the drawings is not intended to limit the scope of the claimed present application, but only represents selected embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative labor fall within the scope of protection of the present application.

[0044] It should be noted that: similar reference numerals and letters represent similar items in the following drawings, therefore, once an item is defined in one drawing, it does not need to be further defined and explained in the subsequent drawings.

[0045] In the description of the utility model, it needs to be explained that if the terms "upper", "lower", "inner", "outer" and the like indicate the orientation or positional relationship shown in the drawings, or the orientation or positional relationship commonly used when the utility model product is used, it is only for the convenience of describing the utility model and simplifying the description, and does not indicate or imply that the device or element indicated must have a specific orientation, be constructed and operated in a specific orientation, so it cannot be understood as a limitation on the utility model.

[0046] In addition, if the terms "first", "second" and the like are used only to distinguish the description, and cannot be understood as indicating or implying relative importance.

[0047] It should be noted that the features in the embodiments of the utility model can be combined with each other without conflict.

[0048] Peripheral vascular disease is a common vascular disease, including arteriosclerosis, arteriovenous thrombosis, vascular stenosis, etc. These diseases can cause blood circulation disorders, causing pain, swelling, numbness, etc., and in severe cases can even cause ischemia and necrosis of the limbs, etc. If the arterial thrombosis occurs in the intracranial and carotid arteries, the symptoms of cerebral infarction can occur, and the light can cause hemiplegia, aphasia, and the heavy can endanger life. Arterial thrombosis occurs in organs, causing ischemia, necrosis and functional changes in the corresponding organs. For example, it can cause necrosis of the intestinal canal and even peritonitis.

[0049] If it occurs in the renal artery, it can cause pain in the kidney, and in severe cases, it can cause renal failure, deep vein thrombosis, and can also cause pulmonary embolism, etc. At present, the treatment methods for peripheral vascular disease mainly include drug treatment, surgical treatment and interventional treatment, etc.

[0050] Among them, interventional therapy as a minimally invasive surgical treatment has the advantages of small trauma, rapid recovery, etc., and has become one of the key means for the treatment of peripheral vascular disease. Arteriovenous thrombus aspiration is the most widely used and effective treatment method in thrombus disease interventional therapy, which can directly intervene in the blood vessel in the form of minimally invasive surgery to aspirate thrombus, thereby achieving the purpose of treating thrombus disease. It is a fast, safe and efficient thrombectomy technology.

[0051] Current thrombectomy catheters consist of a catheter and a suction system. The catheter is typically made of a soft, flexible material and can be inserted into a patient's vein or artery via puncture. The suction system connects the catheter to the outside environment, creating negative pressure near the catheter tip to draw foreign objects out of the blood vessel. Thromboaspiration catheters are simple in structure and are the most widely used technology currently available. For thrombi that cannot be aspirated, a thrombectomy stent is often used. This involves deploying a metal stent to encapsulate the thrombus, pulling it into the catheter for removal from the body, thus achieving the therapeutic procedure.

[0052] Current thrombus aspiration catheters have a flexible, straight tip, meaning the catheter has a straight tip and cannot independently select the blood vessel to enter. It often requires the guidance of a guidewire or pre-shaping of the catheter tip to enter the correct blood vessel. When pushing the catheter through the blood vessel, the straight tip will generate greater resistance in tortuous blood vessels. If the pushing continues, it may cause damage to the inner wall of the blood vessel or dissection, or catheter bending, which seriously affects the success rate of the operation.

[0053] In addition, during the thrombus aspiration process, thrombi that are formed quickly, small in size, located in the middle of the blood vessel, and not adhered to the vessel wall are relatively easy to aspirate due to their formation characteristics. However, thrombi that are deposited, atherosclerotic plaques, thrombi rich in red blood cell complexes and solidified clots, and some larger thrombi, as well as thrombi with a large intravascular load, are more difficult to aspirate.

[0054] Thrombosis increases the risk of blocking the tip of the thrombus aspiration catheter, requiring the instrument to be withdrawn to clear the blockage. This necessitates repeated catheter delivery and aspiration of the thrombus. Repeated aspiration increases the difficulty of the surgery, increases the burden on the patient, and may lead to vascular damage such as dissection or perforation in severe cases. Moreover, the more times the aspiration is repeated, the greater the damage to the blood vessel.

[0055] In view of this, please refer to Figures 1-14 The thrombus cutting adjustable bend aspiration catheter system provided in the embodiments of this utility model can solve this problem, and will be described in detail below.

[0056] Please refer to Figures 1-3 This utility model provides a thrombectomy adjustable bendable aspiration catheter system, which is a medical device used in interventional surgical methods. The thrombectomy adjustable bendable aspiration catheter system can perform thrombectomy treatment on various types of thrombi in blood vessels.

[0057] The thrombus cutting adjustable bending suction catheter system comprises an adjustable bending suction catheter 100 and a thrombus cutting device 200, wherein the adjustable bending suction catheter 100 comprises a suction catheter body 110 and a bending adjusting mechanism 120 connected with the suction catheter body 110, the bending adjusting mechanism 120 is used for controlling the bending degree of the distal end of the suction catheter body 110, and the thrombus cutting device 200 is movably arranged in the suction catheter body 110 to be accommodated or extended out of the suction catheter body 110, and the thrombus cutting device 200 can be completely unfolded when being extended out of the suction catheter to play a role of cutting thrombus.

[0058] Since the bending adjusting mechanism 120 is used for controlling the bending degree of the distal end of the suction catheter body 110, the adjustable bending suction catheter 100 can be adjusted along the bending of the blood vessel at a tortuous part of the blood vessel, so that the suction catheter body 110 can smoothly pass through the tortuous blood vessel and reach the thrombus part, and even can be superselectively inserted into a blood vessel with a large bending angle or a branch blood vessel, so that the vascular compliance of the suction catheter is greatly improved, the probability of bending of the suction catheter body 110 is reduced, and the success rate of the operation is increased.

[0059] In addition, the thrombus cutting adjustable bending suction catheter system comprises the thrombus cutting device 200, by releasing the cutting member 220 of the thrombus cutting device 200, large-load thrombus is cut, and when suction is performed, the suction catheter will not be blocked due to the large thrombus, the repeatability of the operation is reduced, and the efficiency and effect of the operation are improved.

[0060] Therefore, the thrombus cutting adjustable bending suction catheter system can improve the treatment effect and operation efficiency of the interventional thrombus suction treatment, reduce the repetition and complexity of the operation process of medical staff, reduce the pain and treatment cost of the patient in the operation process, and reduce the postoperative complications such as vascular injury and perforation in the operation process.

[0061] It should be noted that in the present application, the terms "proximal end" and "distal end" are medical field terms, specifically, "distal end" means the end far away from the operator during the operation process, and "proximal end" means the end close to the operator during the operation process, and in addition, it should be noted that "distal end" can also be understood as "head end", and "proximal end" can also be understood as "end".

[0062] Specifically, in the present embodiment, the thrombus cutting adjustable bending suction catheter system further comprises a microcatheter 300 Figure 9 as shown, the microcatheter 300 is movably arranged in the suction catheter body 110, the distal end of the microcatheter 300 can be extended out of the distal end of the suction catheter body 110, and the thrombus cutting device 200 is movably arranged in the microcatheter 300 to be accommodated or extended out of the microcatheter 300.

[0063] The microcatheter 300 has a microcatheter head 310, a microcatheter tube 320 and a microcatheter standard female luer connector 330 connected in sequence. The distal end of the microcatheter 300 mentioned above can be understood as the microcatheter head 310 and part of the microcatheter tube 320, or the microcatheter head 310. The distal end of the microcatheter head 310 is tapered to facilitate the insertion of the microcatheter 300 into the blood vessel.

[0064] The material of the microcatheter head 310 (for example, the tube made of nylon material, and the outer wall of the tube has a polyvinylpyrrolidone hydrophilic coating) generally has good lubricity (surface hydrophilic coating) and softness to reduce damage to the blood vessel wall. The microcatheter head 310 is provided with a visualization ring for displaying the position of the microcatheter 300 in the blood vessel under X-ray.

[0065] The microcatheter tube 320 is a multi-layer composite structure, the outer layer is made of smooth polymer material (such as nylon), which has good lubricity, helps to reduce the friction resistance of the catheter in the blood vessel, improves the passability of the catheter, and can reduce the damage to the blood vessel. The middle layer is a reinforcing layer made of metal (such as stainless steel) or carbon fiber material. The inner layer is made of polymer material (such as PDFE), which has good lubricity and softness, increases the delivery performance of the instrument, and the microcatheter standard female luer connector 330 is a standard part for the interface of the instrument and the intervention channel of the thrombectomy device 200.

[0066] The microcatheter 300 has a small diameter, and at the same time as the constraint transmission catheter of the cutting member 220 (described below) of the thrombectomy device 200, it can pass through smaller blood vessel branches, and the microcatheter head 310 can be shaped to achieve superselective intubation of specific lesion sites. This helps to more accurately deliver the thrombectomy device 200 to the lesion area, improving the treatment effect.

[0067] In this embodiment, please refer to Figures 10-14 and in combination with Figure 1 The thrombectomy device 200 includes a flexible head 210, a cutting member 220, a core wire 230 and a control rod 240. The distal end of the flexible head 210 and the core wire 230 are connected, and the distal end of the cutting member 220 and the proximal end of the flexible head 210 are connected.

[0068] The distal end of the control rod 240 is connected with the proximal end of the cutting member 220, and the control rod 240 is sleeved on the core wire 230 in a slidable manner, so that the cutting member 220 is retracted or expanded. For example, when the distal end of the control rod 240 slides close to the flexible head 210, the cutting member 220 is expanded, and when the distal end of the control rod 240 slides away from the flexible head 210, the cutting member 220 is retracted. In order to facilitate the control rod 240 to have flexibility, the peripheral wall of the control rod 240 has a second spiral structure (the second spiral structure is close to the proximal end of the cutting member 220). The head end of the flexible head 210 is a hemispherical structure, which is used as the head end of the thrombectomy device 200 to bear force and not damage the blood vessel wall. The flexible head 210 also has a middle section structure connected with the head end of the flexible head 210 (the proximal end of the middle section structure is connected with the distal end of the core wire 230, and the distal end of the cutting member 220 is connected with the proximal end of the middle section structure).

[0069] The middle section structure has a spiral structure, and the middle section structure can have a developing function. When the flexible head 210 is in a tortuous blood vessel, the head end of the flexible head 210 can transmit force to the middle section structure after touching the blood vessel wall. The middle section structure changes the direction of the transmitted force, and can smoothly pass through the tortuous blood vessel.

[0070] The cutting member 220 is a woven structure composed of a plurality of stainless steel and nickel-titanium alloy wires. The thrombectomy device 200 further comprises a control rod seat 250 connected with part of the control rod 240 (which can be understood as an outer tube of the control rod 240 (to be described below) or the remaining tube structure of the control rod 240 in the outer tube of the control rod 240). The control rod seat 250 connected with the distal end of the control rod 240 is pushed and pulled relative to the core wire 230, so as to control the expansion (equivalent to making the cutting member 220 in a fully expanded state) and retraction (equivalent to making the cutting member 220 in an unexpanded state) of the cutting member 220.

[0071] Furthermore, the core wire 230 is a stainless steel metal core wire 230, which is connected to the middle section structure of the flexible head 210. The core wire 230 is used to support the flexible head 210 of the thrombus cutter 200 as it advances and retracts in the blood vessel. The control rod 240 is located on the surface of the core wire 230 and is a thin-walled circular tube structure. The head end of the control rod 240 is connected to the proximal end of the cutting element 220. Part of the outer wall of the control rod 240 (which can be understood as the other outer walls of the control rod 240 besides the aforementioned second helical structure) is also helically cut to improve the flexibility of the control rod 240. Furthermore, the spiral cutting portion of the control rod 240 and the outer side of the aforementioned second spiral structure can be covered with a polymer tubing (i.e., the outer tube of the control rod 240, such as PTFE tubing) to reduce the friction between the control rod 240 and the inner wall of the microcatheter 300. This prevents the control rod 240 from affecting the inner wall of the microcatheter 300 (the inner wall of the microcatheter 300 can be understood as the inner wall of the microcatheter tip 310, the inner wall of the microcatheter body 320, and the inner wall of the microcatheter standard female Luer connector 330) when controlling the expansion and contraction of the cutting component 220, thus making the delivery process smoother.

[0072] The cut part 220 has three forms, such as the un-unfolded form (e.g.) Figure 14 As shown), at this time, it is retrieved by the microcatheter 300 and placed inside the microcatheter 300 (for example, inside the microcatheter body 320, or it can also be understood as inside the microcatheter tip 310, or it can be simultaneously located inside the microcatheter tip 310 and the microcatheter body 320), facilitating its push within the aspiration catheter (the aspiration catheter can be understood as inside the tip 111, the bending section 112, or the main body 113 mentioned below, or it can be simultaneously inside the tip 111, the bending section 112, and the main body 113, or simultaneously inside the tip 111 and the bending section 112, depending on the actual situation), and also has a naturally unfolded state (such as...). Figure 12 As shown), the cutting element 220 is in its unconstrained state at this time. In this state, the cutting element 220 can cause some damage to large thrombi. If the desired effect cannot be achieved in this state, the control lever seat 250 connecting the cutting element 220 to the control lever 240 can be pushed, and the control lever 240 can fully unfold the cutting element 220 (as shown). Figure 13 As shown, the unfolded cutting element 220 can cut the thrombus into small pieces for easy aspiration. It can be used to directly cut the thrombus, or it can be retrieved into the aspiration tube 110 to cut the thrombus when it blocks the aspiration catheter, while simultaneously being aspirated and removed. The cutting element 220 can also serve as a distal thrombus collection device. During thrombus aspiration using the proximal aspiration catheter, the cutter is released through the microcatheter 300 to the distal end of the thrombus to capture and collect any thrombi that fall off during aspiration.

[0073] The thrombus cutter 200 has hardness for passing through the thrombus and super-elasticity for the blood vessel, does not cause damage to the blood vessel, can control the expansion and contraction of the cutting assembly, and can cut and decompose the thrombus with large volume load, such as soft and hard thrombus and mixed thrombus, so that the suction process can be smoothly performed. The thrombus cutter 200 can also be used as a distal collection device to collect a part of the distal escaped thrombus, and can be quickly withdrawn from the blood vessel after completion.

[0074] In addition, it should be noted that in other embodiments, the cutting member 220 of the thrombus cutter 200 can also have other shapes and sizes, for example, the cutting member 220 in the expanded state can be a cylindrical structure or also an umbrella-shaped structure.

[0075] In addition, the material of the cutting member 220 of the thrombus cutter 200 can be selected from stainless steel wire, nickel-titanium alloy wire, cobalt-chromium alloy wire, high-molecular polytetrafluoroethylene (PTFE), polyurethane, non-metallic materials such as carbon nanotubes, and graphene.

[0076] The adjustable bending suction catheter 100 in the embodiment has the bending adjustment super-selection feature. The head end of the adjustable bending suction catheter 100 (which can be understood as the head end of the head end part 111 described below) can be controlled to face a direction by the bending adjustment mechanism 120. The suction catheter can be selectively inserted into a target blood vessel branch or a specific part with a purpose, so as to reach a position closer to the lesion part in the blood vessel, thereby simplifying the operation process and improving the success rate of the operation.

[0077] In the embodiment, please refer to Figures 3-6 The bending adjustment mechanism 120 includes a tube connector 121, a bending guide wire, and a handle 124. The handle 124 is rotatably connected to the tube connector 121. The distal end of the bending guide wire is connected to the distal end of the suction tube 110. The handle 124 has an adjusting wheel 1241 (which can be understood as a torque adjusting wheel 1241). The adjusting wheel 1241 is connected to the bending guide wire. The adjusting wheel 1241 is used to tighten or loosen the bending guide wire, so as to control the bending degree of the distal end of the suction tube 110.

[0078] Specifically, in the embodiment, the number of the adjusting wheels 1241 is two. The two adjusting wheels 1241 are located in the tube connector 121. The two adjusting wheels 1241 can rotate relative to the tube connector 121. The number of the bending guide wires includes two, which can be understood as a first bending guide wire 122 and a second bending guide wire 123. The first bending guide wire 122 and the second bending guide wire 123 are respectively connected to the two adjusting wheels 1241.

[0079] The main tube part 113 has two first guide wire channels 1101, while the bending part 112 also has two second guide wire channels 1102, the two first channels respectively communicate with the two second channels to form the first guide wire channel 1101 and the second guide wire channel 1102, the first bending guide wire 122 and the second bending guide wire 123 respectively pass through the first guide wire channel 1101 and the second guide wire channel 1102, so that the bending guide wire is connected with the head end part 111 after passing through the guide wire hole of the main tube part 113 and the bending part 112.

[0080] The handle 124 is provided with an instrument channel 1242 (equivalent to the inner cavity of the handle 124), the proximal end of the suction tube body 110 is arranged in the instrument channel 1242.

[0081] In the embodiment, the suction tube body 110 includes the head end part 111, the bending part 112 and the main tube part 113 connected in sequence, and the distal end of the suction tube body 110 can be understood as the head end part 111 and the bending part 112.

[0082] The proximal end of the main tube part 113 is arranged in the instrument channel 1242 of the tube body connector 121, and it is easy to understand that the head end part 111, the bending part 112 and the main tube part 113 are all tubular structures, the head end part 111, the bending part 112 and the main tube part 113 are communicated in sequence, the head end part 111, the bending part 112 and the main tube part 113 can jointly define the inner cavity of the suction tube body 110, the adjusting wheel 1241 is used for tightening or loosening the bending guide wire to control the bending degree of the bending part 112, wherein the head end part 111 has a developing element, the bending guide wire passes through the main tube part 113 and the bending part 112 in sequence, and the head end part 111 is connected with the distal end of the bending guide wire, that is, the head end part 111 is connected with the distal end of the first bending guide wire 122 and the distal end of the second bending guide wire 123 at the same time.

[0083] Specifically, the head end part 111 is made of flexible material, which can reduce the damage to the blood vessel when the suction catheter passes through the blood vessel, and is provided with a developing ring (which can be understood as that the head end part 111 has a developing element) for displaying the position of the suction catheter in the blood vessel.

[0084] Wherein, in order to make the bending section 112 easy to bend, the bending section 112 has a first spiral structure, specifically, the bending section includes an inner layer pipe body structure with a first spiral structure and an outer layer soft plastic pipe body (the soft plastic pipe body can be made of polyurethane (PU), polytetrafluoroethylene (PTFE), silicone rubber, polyether block amide (PEBAX)) arranged outside the inner layer pipe body structure, and the head end section 111 has two anchor bending guide wire structures 1111 for fixing the distal end of the first bending guide wire 122 and the distal end of the second bending guide wire 123 respectively, so as to provide the bending section with the force value required for bending. By rotating the handle 124, the handle 124 is rotated relative to the pipe body connector 121, thereby driving the two adjusting wheels 1241 to rotate, and in the case of winding the first bending guide wire 122, the other adjusting wheel 1241 can unwind the second bending guide wire 123, thereby adjusting the bending degree of the bending section.

[0085] Wherein, the bending guide wire located at the bending section of the suction pipe body 110 is in a straight state under the condition of no force, and starts to bend when subjected to a pulling force, the bending angle is different depending on the size of the transmitted force, and the bending section will restore to a straight state when the pulling force is removed.

[0086] Wherein, in the present embodiment, the main pipe body part 113 is a multi-layer composite structure with an outer pipe body (which can refer to the multi-layer composite structure of the existing suction catheter), and a through passage (the first guide wire passage 1101 mentioned above) for the bending guide wire is arranged in the outer pipe body, wherein the bending guide wire is used to transmit the force transmitted from the handle 124 to the bending section, and is the transmission mechanism of the bendable suction catheter 100.

[0087] Wherein, the two torsion adjusting wheels 1241 of the handle 124 are used to control the tightening and loosening of the bending guide wire, when one adjusting wheel 1241 winds the bending guide wire, the other adjusting wheel 1241 unwinds the bending guide wire, thereby making the distal end of the suction pipe body 110 bend.

[0088] It is easy to understand that in the present embodiment, the two torsion adjusting wheels 1241 are adjacent.

[0089] Wherein, the handle 124 can facilitate the use and adjustment of the grip and fixation of the distal end of the suction pipe body 110 when bending, and the handle 124 has a standard luer connector 1243 at the end, and the standard luer connector 1243 can communicate with the inner cavity of the suction pipe body 110 (i.e. the inner cavity of the main pipe body part 113), and can also be connected to devices such as a hemostatic valve or a negative pressure device, and can also serve as a channel for instruments such as a microcatheter 300, a guide wire, etc.

[0090] The surface of the suction tube body 110 is provided with a hydrophilic coating (for example, the head end 111 is provided with a hydrophilic coating, or in some embodiments, the head end 111 and the tapered portion 112 are both provided with a hydrophilic coating), which facilitates the delivery of the suction catheter in the blood vessel.

[0091] The head end 111 of the suction tube body 110 is provided with a visualization ring for displaying the position of the suction tube body 110 in the blood vessel under X-ray.

[0092] In addition, it should be noted that in the present embodiment, please refer to Figure 7 and in combination with Figure 1 and Figure 2 The thrombus cutting and adjustable bending suction catheter system further comprises a T-shaped hemostasis valve 400, which comprises a first male luer connector 410 (equivalent to a standard male luer connector), a first valve body 420, a first hemostasis connector 430 (equivalent to a screw cap), and a connecting tube 440 in communication with the first valve body 420, which are connected in sequence.

[0093] The first valve body 420 and the connecting tube 440 constitute a T-shaped main body structure 521.

[0094] The first male luer connector 410 is connected to the proximal end of the handle 124 (i.e. the standard luer connector 1243), and the first male luer connector 410 is used to communicate the inner cavity of the suction tube body 110. The microcatheter tube 320 of the microcatheter 300 can be sequentially arranged in the first hemostasis connector 430, the first valve body 420, the first male luer connector 410, the standard luer connector 1243 of the handle 124, and the inner cavity of the suction tube body 110 (as shown in Figure 1 The microcatheter tube 320 of the microcatheter 300 can be arranged out of the head end 111 of the suction tube body 110).

[0095] In addition, the T-shaped hemostasis valve 400 further comprises an extension tube 450 and a female luer connector 460 (equivalent to a first standard female luer connector 460), one end of the extension tube 450 is in communication with the connecting tube 440, and the other end of the extension tube 450 is connected to the female luer connector 460.

[0096] The standard female luer connector 460 is a standardized micro-infiltration connector for the injection connection port of contrast medium, thrombolytic drugs, negative pressure suction device, the extension tube 450 is a tube made of high molecular material (such as polyvinyl chloride (PVC), polyethylene (PE), thermoplastic elastomer (TPE), polyurethane (TPU) and the like), which is used to extend the first valve body 420 to facilitate drug injection and suction, the T-shaped main structure 521 is a T-shaped three-way pipeline for distributing the drug injection and suction and functional extension of the suction catheter, the screw cap is a connecting fastener with a gasket and a silica gel piece inside for one-way sealing after locking the screw cap, and the subsequent medical device can also be inserted into the front device through the silica gel pad, and the standard male luer connector is a standardized micro-infiltration connector.

[0097] In addition, in the embodiment, please refer to Figure 8 and combine Figure 1 and Figure 2 , the thrombus cutting adjustable bending suction catheter system further comprises a Y-shaped valve 500, the Y-shaped valve 500 comprises a second male luer connector 510 (equivalent to a standard male luer connector), a second valve body 520 and a second hemostasis connector 530 (equivalent to a screw cap) connected in sequence.

[0098] The second valve body 520 has a second standard female luer connector, that is, the second valve body 520 comprises a main structure 521 and a second standard female luer connector connected with the main structure 521.

[0099] The second male luer connector 510 and the proximal end of the microcatheter 300 (i.e. the microcatheter standard female luer connector 330) are in communication, the core wire 230 and the control rod 240 of the thrombus cutter 200 pass through the second hemostasis connector 530, the main structure 521 of the second valve body 520, the second male luer connector 510 and the proximal end of the microcatheter 300 in sequence, and specifically, as shown in Figure 1 , the core wire 230 and the control rod 240 can pass out of the microcatheter head end 310 from the microcatheter standard female luer connector 330, of course, the thrombus cutter 200 can also be accommodated in the microcatheter 300.

[0100] The second standard female luer connector 522 of the Y-shaped valve 500 (which can be used to connect an external negative pressure device) is a standardized micro-infiltration connector for pressure relief and hemostasis when connecting the function of the device, the main structure 521 is a Y-shaped three-way pipeline for distributing the pressure relief and hemostasis and functional extension: the screw cap of the Y-shaped valve 500 is a connecting fastener with a gasket and a silica gel piece inside for one-way sealing after locking the screw cap, and the subsequent medical device can also be inserted into the front device through the silica gel pad; and the standard male luer connector is a standardized micro-infiltration connector.

[0101] It is easy to understand that the T hemostasis type valve and the Y type valve 500 are used as a hemostasis function structure, and the T hemostasis type valve can be used in connection with the drug injection and negative pressure suction function in addition to the basic function.

[0102] The thrombus cutting adjustable bending suction catheter system provided by the embodiment, and a method for using the thrombus cutting adjustable bending suction catheter system:

[0103] Vascular puncture: the doctor punctures the patient's artery, usually the femoral artery, and then inserts the suction pipe body 110 of the adjustable bending suction catheter 100 into the blood vessel.

[0104] Catheter navigation: under the guidance of X-ray fluoroscopy, the suction pipe body 110 of the adjustable bending suction catheter 100 is pushed along the blood vessel to the lesion position. When a tortuous or selected blood vessel branch is encountered, the suction pipe body 110 is rotated by a certain scale through the clockwise rotation or counterclockwise rotation of the pipe body connector 121 to realize the bending angle of the corresponding bending of the suction pipe body 110. It can also be seen from the development whether the suction pipe body 110 reaches the blood vessel bending angle or the selected blood vessel. After adjustment, the suction pipe body 110 is pushed again, so that the suction pipe body 110 passes through smoothly and reaches the thrombus position.

[0105] Thrombus cutting and suction: when the suction pipe body 110 of the adjustable bending suction catheter 100 reaches the thrombus position, for the thrombus with low solidification and condensation degree and small volume, negative pressure can be used to suck the thrombus; when the thrombus volume is large or the thrombus formed by a large number of red blood cell condensation has a risk of blocking the pipe, the cutting member 220 of the thrombus cutter 200 can be pushed into the thrombus by the microcatheter 300 from the suction pipe body 110, and the control rod seat 250 connected to the control rod 240 of the thrombus cutter 200 can be pushed to fully deploy the cutting member 220. In this way, the cutting member 220 can cut the thrombus into small pieces for easy suction, or the cutting member 220 can be recovered into the suction catheter lumen to cut the thrombus when the thrombus blocks the suction catheter, and the thrombus can be sucked out of the blood vessel at the same time. When the thrombus escapes to the distal end of the blood vessel, the cutting member 220 is fully deployed at the distal end of the thrombus, and the thrombus is sucked out by the above-mentioned distal end capture and collection and proximal end negative pressure suction. This method can prevent thrombus escape and prevent the possibility of distal vessel embolism.

[0106] Review and evaluation: after the suction is completed, the doctor will perform an imaging examination again to confirm whether the thrombus is completely removed and whether the blood flow is restored to normal.

[0107] Catheter removal: after confirming that the thrombus has been removed and the blood flow has been restored, the doctor will carefully remove the suction pipe body 110 of the adjustable bending suction catheter 100 from the blood vessel.

[0108] In summary, the thrombus cutting adjustable bending suction catheter system provided by the embodiment has at least the following advantages.

[0109] The thrombus cutting adjustable bending suction catheter system is suitable for better cutting and suction of large-load thrombus, deposited thrombus, atherosclerotic plaque, red blood cell-rich complex reinforced clot thrombus and even part of large-volume thrombus or old hard thrombus in a tortuous blood vessel.

[0110] First, the existing suction catheter has a large rigidity, and is difficult to be pushed to a position quickly in a tortuous blood vessel, and even is bent during pushing. The adjustable bending suction catheter 100 in the embodiment can be adjusted along the bending of the blood vessel at a tortuous part of the blood vessel, so that the adjustable bending suction catheter 100 can smoothly pass through the tortuous blood vessel and reach the thrombus part, and even can be super-selected into a large-angle blood vessel or branch blood vessel, thereby greatly enhancing the blood vessel compliance of the suction tube body 110, reducing the bending probability of the suction tube body 110, and increasing the success rate of the operation.

[0111] Second, in the previous thrombus suction operation, mixed thrombus or other large-volume thrombus with large load may cause the head end of the suction catheter to be blocked, interfere with the suction process, and even require multiple suction operations. The thrombus cutter 200 in the embodiment can pass through the thrombus through the lumen of the microcatheter 300, release the cutting member 220, cut the large-load thrombus, and then perform suction. The suction tube body 110 of the adjustable bending suction catheter 100 will not be blocked by the thrombus, thereby reducing the repeatability of the operation, improving the efficiency and effect of the operation.

[0112] Third, in the process of suctioning the thrombus, the extracorporeal negative pressure device can generate a sustained negative pressure to continuously suction the large-load thrombus, and cooperate with the cutting member 220 to cut the thrombus, so that the operation process achieves better results. The cutting member 220 can also be opened at the distal end of the thrombus, and the suction tube body 110 of the adjustable bending suction catheter 100 at the proximal end can be suctioned at the same time, so as to prevent the broken thrombus from escaping to the distal end and being collected and captured.

[0113] The above merely describes specific embodiments of the present application, but the protection scope of the present application is not limited thereto. Any changes or replacements within the technical range disclosed by the present application can be easily thought of by those skilled in the art, and should be covered within the protection scope of the present application. Therefore, the protection scope of the present application should be subject to the protection scope of the claims.

Claims

1. A thrombus-cutting adjustable bendable aspiration catheter system, characterized in that, include: An adjustable-bend suction catheter (100) includes a suction tube body (110) and an adjusting mechanism (120) connected to the suction tube body (110). The adjusting mechanism (120) controls the degree of bending of the distal end of the suction tube body (110). A thrombus cutter (200) is movably disposed on the suction tube body (110) to receive or extend from the suction tube body (110).

2. The thrombus cutting adjustable bend aspiration catheter system according to claim 1, characterized in that, The bending mechanism (120) includes a tube connector (121), a bending guide wire, and a handle (124). The handle (124) is rotatably connected to the tube connector (121). The distal end of the bending guide wire is connected to the distal end of the suction tube (110). The handle (124) has an adjusting wheel (1241). The adjusting wheel (1241) is connected to the bending guide wire. The adjusting wheel (1241) is used to tighten or loosen the bending guide wire to control the degree of bending of the distal end of the suction tube (110). The handle (124) is provided with an instrument channel (1242), and the proximal end of the suction tube (110) passes through the tube connector (121) and is located in the instrument channel (1242).

3. The thrombectomy adjustable bendable aspiration catheter system according to claim 2, characterized in that, The suction tube body (110) includes a head end (111), a bending section (112), and a main tube body (113) connected in sequence. The proximal end of the main tube body (113) passes through the tube body connector (121) and is located in the instrument channel (1242). The adjusting wheel (1241) is used to tighten or loosen the bending guide wire to control the bending degree of the bending section (112). The head end (111) has a developing element, the bending guide wire passes through the main body (113) and the bending part (112) in sequence, and the head end (111) is connected to the distal end of the bending guide wire, and the bending part (112) has a first spiral structure.

4. The thrombus cutting adjustable bend aspiration catheter system according to claim 2, characterized in that, The thrombectomy adjustable bendable aspiration catheter system also includes a microcatheter (300), which is movably disposed in the aspiration tube body (110), and the thrombectomer (200) is movably disposed in the microcatheter (300) to receive or extend the microcatheter (300).

5. The thrombus cutting adjustable bend aspiration catheter system according to claim 4, characterized in that, The thrombus cutting adjustable bend aspiration catheter system also includes a T-type hemostatic valve (400), which includes a first male Luer connector (410), a first valve body (420), a first hemostatic connector (430) connected in sequence, and a connecting tube (440) communicating with the first valve body (420). The first male Luer connector (410) is connected to the proximal end of the handle (124), and the first male Luer connector (410) is used to connect the suction tube body (110). The microcatheter (300) is sequentially inserted through the first hemostatic connector (430), the first valve body (420), the first male Luer connector (410), and the suction tube body (110).

6. The thrombectomy adjustable bendable aspiration catheter system according to claim 5, characterized in that, The T-type hemostatic valve (400) also includes an extension tube (450), which is connected to the connecting tube (440).

7. The thrombectomy adjustable bendable aspiration catheter system according to claim 5, characterized in that, The thrombus cutting adjustable bend aspiration catheter system also includes a Y-type valve (500), which includes a second male Luer connector (510), a second valve body (520), and a second hemostatic connector (530) connected in sequence. The second male Luer connector (510) and the proximal end of the microcatheter (300) are connected, and the thrombus cutter (200) passes through the second hemostatic connector (530), the second valve body (520), the second male Luer connector (510), and the microcatheter (300) in sequence.

8. The thrombus cutting adjustable bend aspiration catheter system according to claim 1, characterized in that, The thrombus cutter (200) includes a flexible head (210), a cutting element (220), a core wire (230), and a control rod (240). The distal ends of the flexible head (210) and the core wire (230) are connected, and the distal end of the cutting element (220) is connected to the proximal end of the flexible head (210). The distal end of the control rod (240) is connected to the proximal end of the cutting element (220), and the control rod (240) is slidably sleeved on the core wire (230) so that the cutting element (220) can contract or expand.

9. The thrombus cutting adjustable bend aspiration catheter system according to claim 8, characterized in that, The peripheral wall of the control rod (240) has a second helical structure.

10. The thrombus cutting adjustable bend aspiration catheter system according to claim 9, characterized in that, The thrombus cutter (200) also includes a control lever seat (250) connected to the control lever (240).

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