Intracranial thrombus aspiration catheter

Abstract

The utility model relates to an intracranial thrombus aspiration catheter which comprises a catheter body, a connector and a balloon, the connector is connected to the near end of the catheter body, and the balloon is arranged outside the far end of the catheter body. The catheter sequentially comprises an inner layer, a reinforcing layer and an outer layer from inside to outside. The outer diameter of the guide pipe ranges from 1.3 mm to 2.8 mm. The maximum diameter of the balloon is 3-20 mm, and the filling amount of the balloon body of the balloon is 0.1-10 ml; a first channel is formed in the outer layer, a second channel is formed in the outer layer, and the second channel is communicated with the inner cavity of the balloon. The balloon is arranged, so that blood flow can be blocked, and the stent can be sucked or conveyed to the diseased region at the far end of the blood vessel. After the balloon is additionally arranged on the catheter, the size of the catheter is still kept not to be increased, and during application, a large-specification blood vessel puncture sheath does not need to be used, so that the puncture risk is reduced.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically to an intracranial thrombus aspiration catheter. Background Technology

[0002] In recent years, with the establishment of regional treatment networks for acute ischemic stroke (AIS) and the continuous improvement of green channels, the rapid and precise imaging screening, the upgrading and development of thrombectomy devices, and the advancement of thrombectomy concepts and techniques, the prognosis of large vessel occlusive AIS has been continuously improving. Mechanical thrombectomy has become the preferred alternative to intravenous thrombolysis, overcoming the disadvantages of short treatment time (4.5 hours) and low revascularization rate of intravenous thrombolysis. However, mechanical thrombectomy also presents new surgical risks, which are gradually becoming an important issue that needs to be addressed: debris and plaque generated during the delivery and operation of the device during mechanical thrombectomy can obstruct distal vessels.

[0003] The current clinical approach involves placing a balloon-guided catheter (BGC) over an intermediate catheter to block proximal blood flow, combined with stent thrombectomy or direct catheter aspiration. This is considered to significantly improve the complete recanalization rate and clinical outcomes. Increasing evidence also confirms the effectiveness of BGCs in the treatment of acute ischemic stroke. However, in actual surgical procedures, BGCs are generally placed in very proximal large vessels, such as the common carotid artery or internal carotid artery. While they can indeed reverse blood flow and prevent further thrombus fragmentation and distal vessel blockage for embolisms in vessels like the carotid artery, they are ineffective for cerebral artery thrombosis due to posterior circulation blood pressure. This necessitates a catheter that can both block blood flow and reach the distal lesion site for aspiration or stent delivery. In other words, the catheter itself must possess the proximal support, overall flexibility, and permeability of a distal access catheter or thrombus aspiration catheter. Simultaneously, the distal blocking device should be able to contract during delivery and expand during occlusion, with its outer wall adhering to the vessel wall to temporarily block blood flow. This ensures no pressure on the blood flow during thrombectomy, preventing fragmented thrombi from obstructing distal vessels. Most importantly, even with the addition of the blocking device, the catheter size must remain constant. To address these issues, some manufacturers use a method of adding a section of material to increase the blocking device while maintaining the same inner diameter. For example, a 6F outer diameter catheter might become 6.5F or 7F, and the outer diameter of the accompanying guiding catheter or long sheath would correspondingly increase to 9F. During application, a 9F vascular puncture sheath must be used. However, a larger vascular sheath size leads to a larger puncture site, increasing patient discomfort and the risk of puncture. Utility Model Content

[0004] The technical problem to be solved by this utility model is to overcome the shortcomings of the prior art and provide an intracranial thrombus aspiration catheter, which solves the technical problem that the outer diameter of the catheter increases after a balloon is installed on the outer sheath, thus affecting the use of the procedure.

[0005] The technical solution adopted by this utility model to solve its technical problem is:

[0006] Provides an intracranial thrombus aspiration catheter, including

[0007] The catheter, connector, and balloon are provided, with the connector connected to the proximal end of the catheter and the balloon positioned outside the distal end of the catheter.

[0008] The catheter consists of an inner layer, a reinforcing layer, and an outer layer from the inside out.

[0009] The outer diameter of the catheter is 1.3-2.8 mm;

[0010] The balloon has a maximum diameter of 3-20 mm and an inflation volume of 0.1-10 ml.

[0011] At least one first channel is formed in the outer layer, and at least one second channel is provided in the outer layer, the second channel being connected to the inner cavity of the balloon.

[0012] Furthermore, the reinforcing layer includes a first reinforcing layer and a second reinforcing layer, wherein the first reinforcing layer is wrapped around the inner layer and the second reinforcing layer is wrapped around the first reinforcing layer.

[0013] Furthermore, the outer layer is made of nylon, pebax, or TPU.

[0014] Furthermore, the inner layer is coated with polytetrafluoroethylene.

[0015] Furthermore, the first reinforcing layer is made of a spring-wound spiral tube;

[0016] Its coil layer thickness is 0.02-0.05mm.

[0017] Furthermore, the second reinforcing layer is a metal braided layer;

[0018] Its thickness is 0.01-0.03mm.

[0019] Furthermore, the distance between the balloon and the distal end of the catheter is 2-10 cm.

[0020] The beneficial effects of this utility model are:

[0021] This invention relates to an intracranial thrombus aspiration catheter, which, in the treatment of acute ischemic stroke, is equipped with a balloon. This balloon can both block blood flow and reach the lesion site distal to the blood vessel for aspiration or stent delivery. Even with the addition of a balloon, the catheter size must remain constant, eliminating the need for a large-diameter vascular puncture sheath and reducing the risk of puncture. Attached Figure Description

[0022] The present invention will be further described below with reference to the accompanying drawings.

[0023] Figure 1 This is a schematic diagram of the intracranial thrombus aspiration catheter of this utility model;

[0024] Figure 2 This is a cross-sectional view of the intracranial thrombus aspiration catheter of this utility model;

[0025] Among them, 1 is the connector, and 11 is the flexible head;

[0026] 2. Balloon;

[0027] 3. Inner layer, 31. First channel;

[0028] 41. First reinforcing layer; 42. Second reinforcing layer;

[0029] 5. Outer layer, 51. Second channel. Detailed Implementation

[0030] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, not all embodiments. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of this utility model.

[0031] This application provides an intracranial thrombus aspiration catheter, which will be described in detail below. It should be noted that the order of description of the following embodiments is not intended to limit the preferred order of the embodiments of this application. Furthermore, the descriptions of each embodiment have their own emphasis; parts not described in detail in a certain embodiment can be referred to in the relevant descriptions of other embodiments.

[0032] To address the technical problem in existing technologies where the outer diameter of catheters increases after balloon insertion, thus affecting surgical procedures, one embodiment of this application provides an intracranial thrombus aspiration catheter. This is described in detail below.

[0033] like Figure 1 and Figure 2 As shown, an intracranial thrombus aspiration catheter includes...

[0034] The catheter, connector 1, and balloon are provided, wherein connector 1 is connected to the proximal end of the catheter and the balloon is positioned outside the distal end of the catheter.

[0035] The catheter consists of an inner layer 3, a reinforcing layer, and an outer layer 5, arranged from the inside out.

[0036] The outer diameter of the catheter is 1.3-2.8 mm;

[0037] The balloon has a maximum diameter of 3-20 mm and an inflation volume of 0.1-10 ml.

[0038] At least one first channel 31 is provided in the outer layer 5, and at least one second channel 51 is provided in the outer layer 5, the second channel 51 being connected to the inner cavity of the balloon.

[0039] Connector 1 is a Luer connector.

[0040] The first channel has 1-4 slots, and the second channel has a maximum of 16 slots, with 1-4 slots forming a group.

[0041] Optional, 2 channels in the first channel, 2*3 channels in the second channel.

[0042] Increasing the number of first channels is for catheter lumen balance. Increasing the number of second channels depends mainly on the balloon length. Since the holes are relatively small, more can be placed to balance the flow rate.

[0043] In this embodiment, the balloon can also be replaced by an umbrella-shaped occlusion piece. The umbrella piece is fixed on the conduit, and a pull rope is threaded through the second channel. The front end of the pull rope is connected to the umbrella piece. The operator can move the umbrella piece by pulling the rope, thereby achieving the same occlusion function as the balloon.

[0044] In this embodiment, a soft tip 11 is provided at the front end of the catheter, and a contrast ring is provided on the catheter at the positions before and after the balloon.

[0045] Specifically, as an optional implementation method in this embodiment, such as Figure 2 As shown, the reinforcing layer includes a first reinforcing layer 41 and a second reinforcing layer 42. The first reinforcing layer 41 is wrapped around the inner layer 3, and the second reinforcing layer 42 is wrapped around the first reinforcing layer 41.

[0046] Specifically, as an optional implementation method in this embodiment, such as Figure 2 As shown, the outer layer 5 is made of nylon, pebax or TPU.

[0047] The hardness is variable, including Pebax 7033, 6333, 4033, and 3533, and can also be mixed to obtain materials with intermediate hardness. The hardness gradually decreases from the proximal end to the distal end.

[0048] The outer layer 5 is a double-lumen tube, with a middle channel and a second channel 51. The middle channel is used to wrap the reinforcing layer, and the second channel 51 is connected to the inner lumen of the balloon. The cross-section of the second channel 51 is a D-shaped structure.

[0049] Specifically, as an optional implementation method in this embodiment, such as Figure 2 As shown, the inner layer 3 is coated with polytetrafluoroethylene.

[0050] Specifically, as an optional implementation method in this embodiment, such as Figure 2 As shown, the first reinforcing layer 41 is a spring-wound spiral tube;

[0051] Its coil layer thickness is 0.02-0.05mm.

[0052] Specifically, as an optional implementation method in this embodiment, such as Figure 2 As shown, the second reinforcing layer 42 is a metal braided layer;

[0053] Its thickness is 0.01-0.03mm.

[0054] The preparation method of the intracranial thrombus aspiration catheter of this utility model:

[0055] Catheter preparation:

[0056] First, a polytetrafluoroethylene coating, namely inner layer 3, is coated on the upper surface of the metal mandrel, with a thickness of 5-30 μm.

[0057] Then, a coil layer, namely the first reinforcing layer 41, is wound on the surface of the metal core rod, with a coil layer thickness of 0.02-0.05mm;

[0058] Next, a metal braided layer, namely the second reinforcing layer 42, is applied to the surface of the coil layer. The thickness is 0.01-0.03 mm, and the cross thickness is 0.02-0.06 mm, to obtain the semi-finished product 1.

[0059] Then, an outer tube with multiple cavities and different hardness sections (outer layer 5) is placed over the semi-finished product 1, i.e., the outer layer 5, which can be silver-plated wire or coated stainless steel. A heat shrink tubing is then placed over it and heated in a heating cylinder to fully melt the outer layer 5 and the semi-finished product 1. The heat shrink tubing is then peeled off to obtain the semi-finished product 2.

[0060] Balloon implantation:

[0061] Two imaging markers were installed at both ends of the balloon, which was then installed at the target position in the mid-to-remote range and welded using laser welding. The laser parameters were: wavelength 900–120 nm, frequency 50–100 Hz, spot diameter 0.1–1.2 mm, and power 40–120 W.

[0062] Connector 1 Installation:

[0063] Use medical-grade instant adhesive or UV adhesive, such as Loctite 4161 and 3201, to bond the tube into the assembly position inside the socket. Apply adhesive to the first and second contact surfaces near the proximal end; bond them together to maintain firmness and sealing performance.

[0064] coating:

[0065] Pressure was injected into the second channel 51 through connector 1 to inflate the balloon, and a polyvinylpyrrolidone (PVP) coating was applied to the mid-distal section. The distal 40 cm of the catheter was immersed in the solution tube and lifted at a rate of 0.5–1 mm / s, followed by irradiation with 365 nm ultraviolet light for 5 minutes.

[0066] All the devices (parts whose specific structures are not specified) selected in this application are general standard parts or parts known to those skilled in the art. Their structures and principles can be learned by those skilled in the art through technical manuals or conventional experimental methods.

[0067] In the description of the embodiments of this utility model, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0068] In the description of this utility model, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the accompanying drawings and are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0069] In the several embodiments provided in this application, it should be understood that the disclosed systems, apparatuses, and methods can be implemented in other ways. The apparatus embodiments described above are merely illustrative. For example, the division of units is only a logical functional division, and in actual implementation, there may be other division methods. Furthermore, multiple units or components may be combined or integrated into another system, or some features may be ignored or not executed. Additionally, the shown or discussed mutual couplings, direct couplings, or communication connections may be through some communication interfaces; indirect couplings or communication connections between devices or units may be electrical, mechanical, or other forms.

[0070] The units described as separate components may or may not be physically separate. The components shown as units may or may not be physical units; that is, they may be located in one place or distributed across multiple network units. Some or all of the units can be selected to achieve the purpose of this embodiment according to actual needs.

[0071] In addition, in the various embodiments of this utility model, each functional unit can be integrated into one processing unit, or each unit can exist physically separately, or two or more units can be integrated into one unit.

[0072] Based on the above-described preferred embodiments of this utility model, and through the foregoing description, those skilled in the art can make various changes and modifications without departing from the technical concept of this utility model. The technical scope of this utility model is not limited to the contents of the specification, but must be determined according to the scope of the claims.

Claims

1. An intracranial thrombus aspiration catheter, characterized in that, include The catheter, connector (1), and balloon (2) are provided, wherein the connector (1) is connected to the proximal end of the catheter and the balloon (2) is positioned outside the distal end of the catheter. The catheter consists of an inner layer (3), a reinforcing layer, and an outer layer (5) from the inside out. The outer diameter of the catheter is 1.3-2.8 mm; The balloon (2) has a maximum diameter of 3-20 mm and an inflation volume of 0.1-10 ml. At least one first channel (31) is provided in the outer layer (5), and at least one second channel (51) is provided in the outer layer (5), the second channel (51) being connected to the inner cavity of the balloon (2).

2. The intracranial thrombus aspiration catheter according to claim 1, characterized in that, The reinforcing layer includes a first reinforcing layer (41) and a second reinforcing layer (42), wherein the first reinforcing layer (41) is wrapped around the inner layer (3) and the second reinforcing layer (42) is wrapped around the first reinforcing layer (41).

3. The intracranial thrombus aspiration catheter according to claim 2, characterized in that, The outer layer (5) is made of nylon, pebax or TPU.

4. The intracranial thrombus aspiration catheter according to claim 2, characterized in that, The inner layer (3) is coated with polytetrafluoroethylene.

5. The intracranial thrombus aspiration catheter according to claim 2, characterized in that, The first reinforcing layer (41) is made of spring-wound spiral tube; Its coil layer thickness is 0.02-0.05mm.

6. The intracranial thrombus aspiration catheter according to claim 2, characterized in that, The second reinforcing layer (42) is a metal braided layer; Its thickness is 0.01-0.03mm.

7. The intracranial thrombus aspiration catheter according to claim 1, characterized in that, The distance between the balloon (2) and the distal end of the catheter is 2-10 cm.

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