Cutting guidewire and thrombus aspiration system

Abstract

In the cutting guidewire and thrombus aspiration system according to the present application, the cutting guidewire includes a guidewire body and a thrombus cutting member, the distal end of the guidewire body is suitable for being inserted into an aspiration catheter, the thrombus cutting member is connected to the distal end of the guidewire body and is suitable for being disposed in the aspiration catheter, and has a cutting state in which the thrombus cutting member moves in the aspiration catheter by being driven by the guidewire body to cut the thrombus in the aspiration catheter, and the thrombus cutting member includes a cutting portion, the cross-sectional area of ​​which gradually increases along the direction from the distal end to the proximal end. The thrombus cutting member is connected to the distal end of the guidewire body, the thrombus cutting member includes a cutting portion, and the cross-sectional area of ​​the cutting portion gradually increases along the direction from the distal end to the proximal end. When the thrombus cutting member is disposed in the aspiration catheter and moved by the guidewire body to cut the thrombus in the aspiration catheter, the pointed cutting portion can cut and crush the thrombus stuck in the aspiration catheter, thereby avoiding the occurrence of blockage inside the aspiration catheter.

Description

[Technical Field]

[0001] This application claims priority to a Chinese patent application bearing application number 202211439559.5 and entitled "Cutting Guidewire and Thrombus Aspiration System," filed with the China Patent Office on November 17, 2022, the entire contents of which are incorporated herein by reference.

[0002] This application relates to the field of medical devices, and more particularly to cutting guidewires and thrombus aspiration systems. [Background technology]

[0003] Thrombus aspiration is an effective method that has been applied clinically in recent years. It aims to rapidly remove thrombus obstructing diseased blood vessels by mechanical action, thereby reducing thrombus burden and microvascular embolism, altering coronary artery blood flow, and reducing the possibility of postoperative "decreased blood flow" or "no reflow."

[0004] The thrombus aspiration catheter system in the prior art includes a negative pressure suction pump, a thrombus aspiration catheter, an inner tube, a Y-shaped connector, and a guidewire. During use, the guidewire is first advanced to the lesion in the human body, and then the thrombus aspiration catheter and the inner tube are inserted into the lesion along the tail end of the very smooth guidewire. The negative pressure suction pump is connected to the thrombus aspiration catheter via the Y-shaped connector, and the guidewire and inner tube are withdrawn. Subsequently, a negative pressure is applied to the thrombus aspiration catheter by a negative pressure suction device, aligning the end of the catheter with the thrombus, and the thrombus is then sucked out of the blood vessel by the thrombus aspiration catheter and removed from the body.

[0005] However, while the above-mentioned thrombus aspiration catheter system can aspirate fresh, soft emboli and acute thrombus clots, when aspirating subacute thrombi, the tube is likely to become clogged, further hindering the thrombus aspiration by the thrombus aspiration catheter. Summary of the Invention [Problem to be solved by the invention]

[0006] Therefore, the technical problem that this application aims to solve is that while conventional thrombus aspiration catheter systems can aspirate fresh, soft emboli and acute thrombus clots, when aspirating subacute thrombi, the tube is likely to become clogged, further hindering the suction of thrombi by the thrombus aspiration catheter. [Means for solving the problem]

[0007] For this reason, the present application a guidewire body having a distal end adapted to be inserted into an aspiration catheter; a thrombus-cutting member connected to the distal end of the guidewire body, disposed within the aspiration catheter, and configured to move within the aspiration catheter by being driven by the guidewire body and to have a cutting state for cutting a thrombus within the aspiration catheter; The thrombus cutting member includes a cutting portion, the cross-sectional area of ​​which gradually increases along the direction from the distal end to the proximal end of the cutting guidewire.

[0008] Optionally, the sidewall surface of the cut portion is a truncated cone or a paraboloid.

[0009] Optionally, a plurality of protrusions and / or a plurality of recesses are provided on the peripheral side surface of the cutting portion.

[0010] Optionally, the thrombus-cutting member further includes a connecting portion connected between the guidewire body and the cutting portion.

[0011] Optionally, the cross-sectional area of ​​the connection portion gradually increases along a direction from the proximal end to the distal end.

[0012] Optionally, the connection portion is a truncated cone structure or a parabolic structure.

[0013] Optionally, the thrombus-cutting member further includes a helical portion, the helical portion being connected to the connecting portion, and the guidewire body being inserted into the helical portion.

[0014] Optionally, the guidewire further includes a knob connected to the proximal end of the guidewire body to rotationally drive the guidewire body.

[0015] A thrombus aspiration system including the cutting guidewire described above.

[0016] Optionally, the device may further include a negative pressure member, a connector, a cutting guidewire, a suction catheter, and a catheter handle, wherein the connector is connected between the negative pressure member and the suction catheter, the catheter handle is connected to the proximal end of the suction catheter, the cutting guidewire is suitable for being positioned within the suction catheter, and a plurality of side holes are provided in the side wall of the distal end of the suction catheter. [Effects of the Invention]

[0017] The cutting guidewire and thrombus aspiration system according to the present application have the following advantages.

[0018] 1. The cutting guidewire of the present application comprises a guidewire body and a thrombus-cutting member, the distal end of the guidewire body being suitable for insertion into an aspiration catheter, the thrombus-cutting member being connected to the distal end of the guidewire body, the thrombus-cutting member being disposed within the aspiration catheter and being in a cutting state in which it moves within the aspiration catheter as the guidewire body is driven to cut thrombi within the aspiration catheter, and the thrombus-cutting member comprises a cutting portion, the cross-sectional area of ​​which gradually increases in the direction from the distal end to the proximal end.

[0019] 2. In the cutting guidewire according to the present application, the thrombus cutting member further includes a spiral portion, the spiral portion is connected to the connecting portion, and the guidewire body is inserted into the spiral portion.

[0020] A cutting guide wire with this structure has a spiral portion at the connection portion, so that when removing a thrombus, the entire spiral portion is inserted into the thrombus to cut and crush the thrombus, and then when the spiral portion is pulled out from the thrombus, the spiral portion pulls the crushed thrombus out of the thrombus mass, further improving the thrombus removal effect.

[0021] 3. The thrombus aspiration system of the present application further includes a negative pressure member, a connector, a cutting guidewire, an aspiration catheter, and a catheter handle, wherein the connector is connected between the negative pressure member and the aspiration catheter, the catheter handle is connected to the proximal end of the aspiration catheter, the cutting guidewire is suitable for being positioned within the aspiration catheter, and a plurality of side holes are provided in the side wall of the distal end of the aspiration catheter.

[0022] In this thrombus aspiration system, multiple side holes are provided in the side wall of the distal end of the aspiration catheter, making it possible to remove thrombi from the inner wall of a blood vessel simply by using a thrombus aspiration catheter that is much smaller than the inner diameter of the blood vessel. Furthermore, if the opening at the tip of the aspiration catheter or the mouth of one of the side holes is blocked by a thrombus, the thrombus can be continued to be aspirated through the other openings without having to replace the catheter, allowing for rapid and thorough aspirating of the thrombus and reducing blood loss. [Brief explanation of the drawings]

[0023] In order to more clearly describe the specific embodiments of the present application or the technical solutions of the prior art, the following will briefly describe the drawings that need to be used to describe the specific embodiments or the prior art. It is obvious that the drawings in the following description are some embodiments of the present application, and those skilled in the art can also derive other drawings based on these drawings without any creative work.

[0024] [Figure 1] 1 is a schematic diagram of the overall structure of a cutting guide wire and a thrombus aspiration system according to an embodiment of the present application. [Figure 2]1 is a structural schematic diagram of a catheter handle of a cutting guide wire and thrombus aspiration system according to an embodiment of the present application. [Figure 3] 1 is an exploded structural schematic diagram of a catheter handle of a cutting guide wire and a thrombus aspiration system according to an embodiment of the present application. [Figure 4] 1 is a structural schematic diagram of the distal end of a cutting guide wire and a thrombus aspiration system according to an embodiment of the present application. [Figure 5] 1 is a structural exploded schematic diagram of the distal end of a cutting guidewire and thrombus aspiration system according to an embodiment of the present application. [Figure 6] 1 is a structural schematic diagram of a cutting guide wire and a thrombus cutting member of a thrombus aspiration system according to an embodiment of the present application. [Figure 7] 10 is another structural schematic diagram of the thrombus cutting member of the cutting guide wire and thrombus aspiration system according to an embodiment of the present application. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0025] The technical solution of the present application will be described below clearly and completely with reference to the drawings, and it is obvious that the described embodiments are only some of the embodiments of the present application, but not all of the embodiments, and all other embodiments that a person skilled in the art can obtain without creative work based on the embodiments of the present application fall within the scope of protection of the present application.

[0026] It should be understood that orientations or positional relationships indicated by terms such as "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer" in the description of this application are based on illustrations and are intended merely to facilitate and simplify the description of this application, and do not indicate or imply that such devices or elements necessarily have a specific orientation or are configured and operated in a specific orientation, and therefore are not intended to limit the present application. It should also be understood that terms such as "first," "second," and "third" are used for descriptive purposes only and do not indicate or imply relative importance. Furthermore, the technical features of various embodiments of this application described below may be combined with each other unless they are mutually inconsistent.

[0027] It should be noted that in the present description, the distal end is the end closest to the thrombus-cutting member, and the proximal end is the end closest to the catheter handle.

[0028] Example 1 This embodiment provides a cutting guidewire, which, as shown in Figures 1 to 7, includes a guidewire body 1 and a thrombus-cutting member 2. The thrombus-cutting member 2 is connected to the distal end of the guidewire body 1. The distal end of the guidewire body 1 and the thrombus-cutting member 2 are intended to be inserted into an aspiration catheter 3. By manually holding the proximal end of the guidewire body 1 and driving the thrombus-cutting member 2 to move it back and forth within the aspiration catheter 3, the thrombus within the aspiration catheter 3 is cut, and the aspiration catheter 3 is prevented from being blocked, which would hinder the aspiration of the thrombus by the thrombus-aspiration catheter 3.

[0029] 6 and 7, the thrombus-cutting member 2 includes a cutting portion 21 and a connecting portion 22, and the connecting portion 22 is connected between the guidewire body 1 and the cutting portion 21. The cross-sectional area of ​​the cutting portion 21 gradually increases from the distal end to the proximal end, that is, the cutting portion 21 has a truncated cone-shaped structure, a cone-shaped structure, or a paraboloid-shaped structure.

[0030] It can be understood that in some other embodiments, the cutting portion 21 may have other pointed structures, where the pointed structures allow the cutting portion 21 to be easily inserted into the thrombus when it comes into contact with the thrombus, thereby cutting and crushing the thrombus.

[0031] It can be understood that in some other embodiments, the surface of the cutting portion 21 may have multiple protrusions or multiple recesses, which can improve the thrombus cutting effect.

[0032] As shown in FIG. 6, the connecting portion 22 is columnar, and the columnar structure makes it easier for the thrombus cutter 2 to move within the thrombus.

[0033] In some other embodiments, the cross-sectional area of ​​the connecting portion 22 gradually increases along the direction from the proximal end to the distal end, ie, the connecting portion 22 is a truncated cone or a parabolic shape.

[0034] In some other embodiments, the thrombus-cutting member 2 further includes a spiral portion 23, which is fixedly connected to the connecting portion 22, and the guidewire body 1 is inserted into the spiral portion 23. When removing the thrombus, the spiral portion 23 is inserted into the thrombus to cut and crush the thrombus. When the spiral portion 23 is then pulled out from the thrombus, the spiral portion 23 pulls out the crushed thrombus from the thrombus mass, further improving the thrombus removal effect.

[0035] In some other embodiments, a knob is connected to the proximal end of the guidewire body 1, allowing the operator to control the rotation of the guidewire body 1 by means of the knob.

[0036] Here, the guidewire body 1 is made of a nickel-titanium alloy material, which has excellent shape memory properties, and the surface of the distal end of the guidewire body 1 includes a hydrophilic coating, making the guidewire body 1 easy to operate.

[0037] In some other embodiments, the guidewire body 1 and the thrombus-cutting member 2 are arranged at an included angle at the connection point, i.e., there is an included angle between the axis of the guidewire body 1 and the axis of the thrombus-cutting member 2, so that the curved thrombus-cutting member 2 can crush the thrombus and detach it from the blood vessel wall, which is more advantageous for thrombus absorption.

[0038] Example 2 This embodiment provides a thrombus aspiration system, which includes an aspiration catheter 3, a catheter handle 4, a bushing 5, a sheath tube 6, and a cutting guide wire, as shown in Figures 1 to 7, and the cutting guide wire is the cutting guide wire in Example 1.

[0039] As shown in Figures 2 and 3, the catheter handle 4 is inserted into the sheath tube 6, which is inserted into the aspiration catheter 3 via the bushing 5, the distal end of the cutting guide wire is inserted into the aspiration catheter 3, and the catheter handle 4 is used to control the catheter.

[0040] 4 and 5, multiple side holes 31 are provided at the distal end of the aspiration catheter 3, and side holes 31 are provided on the side wall of the distal end of the aspiration catheter 3, so that thrombi on the inner wall of the blood vessel can be removed simply by using a thrombus aspiration catheter 3 that is much smaller than the inner diameter of the blood vessel. Furthermore, if the opening at the tip of the aspiration catheter 3 or the opening of one of the side holes 31 is blocked by a thrombus, the thrombus can continue to be aspirated through the other opening without having to replace the catheter, allowing thrombi to be aspirated quickly and thoroughly and reducing blood loss.

[0041] It is understood that the number of side holes 31 can be determined according to the size or usage needs of the suction catheter 3, for example, 2, 3, 5, 8, etc., and preferably, the side holes 31 are provided on different sides of the suction catheter 3, thereby achieving a wider range of thrombus suction.

[0042] Here, the suction catheter 3 adopts a three-layer composite coating technology, the inner layer is a PTFE layer, which has low resistance and is advantageous for the passage of thrombi, the middle layer is a stainless steel braided structure, which has high support, good pushability and bending resistance, and the outer layer is Pebax resin, which has good biocompatibility, and both ends of the side hole 31 are equipped with development marker points that can indicate the position of the side hole 31, and a tip development segment is provided at the tip of the suction catheter 3 to indicate the position of the tip.

[0043] In some other embodiments, the thrombus aspiration system further includes a negative pressure member and a connector, and the connector is connected between the negative pressure member and the aspiration catheter 3, where the negative pressure member is a negative pressure aspiration pump and the connector is a rotary or push-down Y-valve, which can effectively prevent blood leakage.

[0044] The operation process of the thrombus aspiration system according to this embodiment is as follows.

[0045] First, the cutting guidewire is advanced along the associated instrument to the lesion site in the human body. Next, the suction catheter 3 is inserted into the lesion site along the tail end of the cutting guidewire. The negative pressure suction pump is connected to the side branch of the Y-shaped connector and tightened, and the cutting guidewire is withdrawn. Negative pressure is then applied using the negative pressure suction pump to stabilize the pressure. After the pressure has stabilized, the catheter is slowly pushed and rotated to align the catheter's side hole 31 with the thrombus, which is then aspirated from the blood vessel and removed to the outside of the body. If a tube obstruction occurs, the thrombus is cut using the associated cutting guidewire, and aspirated while cutting.

[0046] Obviously, the above examples are merely examples for the purpose of clarity and explanation, and are not intended to limit the embodiments. Those skilled in the art can further make various other modifications and changes based on the above description. It is not necessary or possible to list all embodiments here. Any obvious modifications and changes derived therefrom are also intended to fall within the scope of protection of the present application. [Explanation of symbols]

[0047] 1. Guidewire body 2. Thrombus cutting element 21, cutting section 22. Connection part 23, spiral part 3. Suction catheter 31, side hole 4. Catheter handle 5. Bushing 6. Sheath tube

Claims

1. A cutting guide wire disposed within a suction catheter (3), a guidewire body (1) whose distal end is inserted into the aspiration catheter (3); a thrombus-cutting member (2) connected to the distal end of the guidewire body (1) and disposed within the aspiration catheter (3), the thrombus-cutting member (2) moving within the aspiration catheter (3) by being driven by the guidewire body (1) and having a cutting state for cutting a thrombus within the aspiration catheter (3); The thrombus-cutting member (2) includes a cutting portion (21), the cross-sectional area of ​​which gradually increases along the direction from the distal end to the proximal end; The thrombus cutting member (2) further includes a connecting portion (22) connected between the guidewire body (1) and the cutting portion (21), the cross-sectional area of ​​the connecting portion (22) gradually increasing in the direction from the proximal end to the distal end, and the connecting portion (22) having a truncated cone structure or a parabolic structure.

2. 2. The cutting guide wire according to claim 1, wherein the side wall surface of the cutting portion (21) is a truncated cone surface or a paraboloid surface.

3. 2. The cutting guide wire according to claim 1, wherein a plurality of protrusions and / or a plurality of recesses are provided on the peripheral side surface of the cutting portion (21).

4. The cutting guide wire according to claim 3, characterized in that the thrombus cutting member (2) further includes a spiral portion (23), the spiral portion (23) is connected to the connecting portion (22), and the guide wire body (1) is inserted into the spiral portion (23).

5. The cutting guidewire according to claim 4, further comprising a knob connected to the proximal end of the guidewire body (1) for rotationally driving the guidewire body (1).

6. A thrombus aspiration system comprising the cutting guidewire according to any one of claims 1 to 5 and the aspiration catheter (3).

7. The thrombus aspiration system according to claim 6, further comprising a negative pressure member, a connector, and a catheter handle (4), wherein the connector is connected between the negative pressure member and the suction catheter (3), the catheter handle (4) is connected to the proximal end of the suction catheter (3), and a plurality of side holes (31) are provided in the side wall of the distal end of the suction catheter (3).

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