Thrombus stirring device

Abstract

The present invention relates to a thrombus stirring device, which comprises a first sheath tube, a second sheath tube slidably sleeved outside the first sheath tube, and a stirring assembly arranged at the distal end of the first sheath tube; the stirring assembly comprises a plurality of stirrers arranged in sequence along the axial direction of the first sheath tube and having a folded state and an expanded state, and two adjacent stirrers are connected by an elastic member so that the two adjacent stirrers can be relatively close to or far away from each other along the axial direction of the first sheath tube; when the stirrer is in the folded state, the stirring assembly is located in the second sheath tube, so as to facilitate the implantation of the thrombus stirring device into a blood vessel and its recovery from the blood vessel; when the stirrer is in the expanded state, the stirring assembly is separated from the second sheath tube. The present invention has a simple structure, low preparation cost, and convenient operation, and can well remove old thrombi with little damage to blood vessels.

Description

Technical Field

[0001] The invention belongs to the field of medical devices, and in particular relates to a thrombus stirring device. Background Art

[0002] Thrombotic diseases include arterial thrombosis, venous thrombosis and thromboembolism. Existing treatment methods mainly include vascular embolectomy, catheter-directed thrombolysis and percutaneous mechanical embolectomy. The embolectomy requires anatomical separation and vascular incision, such as femoral artery, femoral vein or brachial artery incision. With the development of intracavitary interventional technology and the innovation of materials, this open surgical method has been gradually replaced by minimally invasive intracavitary treatment, namely catheter-directed thrombolysis and percutaneous mechanical embolectomy. Catheter-directed thrombolysis has a high risk of bleeding due to thrombolytic drugs and extremely strict surgical indications. A large proportion of patients have contraindications to catheter-directed thrombolysis, so many patients cannot benefit from it.

[0003] Based on existing medical knowledge, deep vein thrombosis often has a large volume, and the acute thrombus is soft and fragile; arterial thrombosis often has a small volume, and the acute thrombus is soft; old thrombus often adheres to the blood vessel wall. As for old thrombus, the existing thrombus removal device mainly uses a spiral cutter at the front end of the catheter to cut the thrombus and extract the blood clot out of the body through suction, such as the X-sizer thrombus removal catheter system. Chinese patent CN204092102U discloses a new type of peripheral vascular disease thrombus suction connector, including: a tube body, a rotating rod, a spiral rotating sheet, an arc joint, and a connecting tail seat. The tube body is hollow, and the upper end of the tube body is movably connected to the arc joint through a thread. A rectangular groove is opened in the upper and middle part of the tube body, and a rotating rod is inserted into the tube body. The outer sleeve of the rotating rod is provided with a spiral rotating sheet. However, the above-mentioned thrombus removal device has a complex structure, high manufacturing cost, and is cumbersome to use. In addition, when the thrombus on the blood vessel wall is peeled off by the rotation of the spiral cutter or the spiral rotating blade in the blood vessel, the blood vessel endothelium is easily damaged. Summary of the invention

[0004] The technical problem to be solved by the present invention is to provide a thrombus stirring device with different structures.

[0005] In order to solve the above technical problems, the present invention adopts the following technical solutions:

[0006] A thrombus stirring device comprises a first sheath tube, a second sheath tube slidably sleeved outside the first sheath tube, and a stirring assembly arranged at the distal end of the first sheath tube; the stirring assembly comprises a plurality of stirrers arranged in sequence along the axial direction of the first sheath tube and having a folded state and an expanded state, two adjacent stirrers are connected by an elastic member so that the two adjacent stirrers can be relatively close to or away from each other along the axial direction of the first sheath tube; when the stirrer is in the folded state, the stirring assembly is located in the second sheath tube, so that the thrombus stirring device is conveniently implanted into and recovered from the blood vessel; when the stirrer is in the expanded state, the stirring assembly is separated from the second sheath tube. During operation, by withdrawing the second sheath tube toward the proximal end, the plurality of stirrers are separated from the second sheath tube and automatically expanded, and the medical staff drags the first sheath tube back and forth to make the stirring assembly move back and forth in the blood vessel, and the plurality of stirrers scrape the blood vessel wall back and forth and stir the thrombus in the blood vessel, so as to achieve the detachment of the thrombus from the blood vessel wall, the crushing of the thrombus and the capture of the thrombus. The proximal end in this article is defined as the side closer to the medical staff when the thrombus stirring device is in use; the distal end is defined as the side away from the medical staff when the thrombus stirring device is in use.

[0007] The present invention arranges two adjacent stirrers to be elastically connected by an elastic member, so that when the first sheath tube is dragged back and forth, a certain buffering effect is provided between the plurality of stirrers and between the stirrers and the blood vessel.

[0008] The number of agitators can be set as needed, preferably 2 to 3.

[0009] Among them, the elastic part can be a thin-walled tube. According to one embodiment, the elastic part is a spring. The spring referred to in this article includes all parts with a spring-like spiral shape and thus elasticity. It is easy to process in terms of technology. During use, the elastic part can pass through complex diseased blood vessels, and at the same time, the flexibility of the sheath and the agitator diameter can be improved.

[0010] The elastic member and the first sheath tube may be welded or integrally provided. Preferably, the elastic member and the first sheath tube are integrally provided, that is, a spring-like elastic member is formed by spiral cutting on a section of the first sheath tube, thereby making the preparation convenient and having good firmness.

[0011] Preferably, when the elastic member is in a stationary state, the distance between two adjacent agitators is 5-10 mm, thereby improving the flexibility of the agitator during dragging.

[0012] Preferably, the stirrer is a mesh basket made of memory wire, for example, it can be formed by laser cutting and heat setting of a nickel-titanium alloy tube. The arrangement of the mesh basket makes the contact area between the stirrer and the blood vessel wall small when the stirrer is dragged back and forth, thereby causing less damage to the blood vessel wall, and the stirrer can partially break up and intercept and capture the thrombus in the blood vessel.

[0013] Further preferably, the projection of the agitator on a plane perpendicular to the axis of the first sheath tube is in the shape of a petal, and the number of petals can be set according to actual needs, preferably set to 4 to 6 petals, so as to ensure an effective interception surface.

[0014] Further preferably, the projections of the plurality of agitators on a plane perpendicular to the axis of the first sheath tube are staggered with each other, thereby increasing the effective interception area for intercepting thrombus.

[0015] The "plane perpendicular to the axis of the first sheath tube" defined herein is Figure 1 The axis defined by the straight extension of the first sheath shown in the figure is perpendicular to the straight axis.

[0016] Preferably, the stirrer is spherical, which is not easy to scratch the blood vessel wall, has good wall-adherence performance, and is easy to remove old wall-adherent thrombi.

[0017] Further preferably, the diameter of the agitator is 9-14 mm, so that the agitator can adapt to blood vessels with different inner diameters.

[0018] The memory wire in this article can be a memory alloy such as nickel-titanium alloy.

[0019] Preferably, the first sheath tube passes through the plurality of agitators, and the axis of the first sheath tube and the center lines of the plurality of agitators coincide with each other, thereby making the thrombus stirring device easy to prepare, simple to operate and less damaging to the blood vessel wall.

[0020] Due to the implementation of the above technical solution, the present invention has the following advantages compared with the prior art:

[0021] The invention has a simple structure, low preparation cost, and convenient operation, and can well remove old thrombi with little damage to blood vessels. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Attached Figure 1 is a schematic structural diagram of a thrombus removal system according to a specific implementation method;

[0023] Attached Figure 2 for Figure 1 AA section view;

[0024] Attached Figure 3 for Figure 1 BB cross-section diagram;

[0025] Attached Figure 4 for Figure 1 CC profile of ;

[0026] Attached Figure 5 It is a schematic diagram of the overlap of the BB section diagram and the CC section diagram;

[0027] Attached Figure 6 for Figure 1 A local enlarged view of the D position;

[0028] Attached Figure 7 for Figure 1 A local enlarged view of the E position;

[0029] Attached Figure 8 It is a schematic diagram of the structure of the stirring device before being deployed in the first embodiment (the second sheath tube has been withdrawn, but before the stirrer is turned on);

[0030] Attached Fig. 9 It is a schematic diagram of the structure of the stirring device after the implementation mode 1 is deployed;

[0031] Attached Fig.10 It is a schematic structural diagram of the stirring device after being unfolded in the second embodiment;

[0032] Attached Fig.11 This is a schematic structural diagram of the stirring device of the second embodiment before and after it is unfolded;

[0033] Among them, 1. suction catheter; 2. guide wire; 11. suction channel; 12. guide wire channel; 13. filling channel; 14. inclined plane; 15. filling interface; 16. suction interface; 17. other equipment interface; 18. balloon; 31. occluding catheter; 32. occluder; 41. first sheath; 42. second sheath; 43. agitator; 44. memory wire; 45. elastic part. DETAILED DESCRIPTION

[0034] The present invention is further described in detail below in conjunction with specific examples. It should be understood that these examples are used to illustrate the basic principles, main features and advantages of the present invention, and the present invention is not limited to the following examples.

[0035] like Figure 1 As shown, the thrombus removal system of the present invention includes a suction catheter 1, a guide wire 2, a stirring device and a blocking device.

[0036] The suction catheter 1 has a suction channel 11 for suctioning thrombus, a guidewire channel 12 for inserting the guidewire 2, and a filling channel 13. The suction channel 11 extends along the axial direction of the suction catheter 1 and passes through both ends of the suction catheter 1, the guidewire channel 12 is located at the distal end of the suction catheter 1, and the filling channel 13 extends along the axial direction of the suction catheter 1.

[0037] The filling channel 13, the suction channel 11, and the guide wire channel 12 are separated from each other and are not connected, and the filling channel 13 and the guide wire channel 12 are respectively located on both sides of the suction channel 11, such as Figure 2 shown.

[0038] The distal end surface of the suction catheter 1 is a bevel 14, such as Figure 7 As shown, the outlets of the distal ends of the suction channel 11 and the guidewire channel 12 are both opened on the inclined surface 14 , and the outlet of the guidewire channel 12 is located at the distal end of the inclined surface 14 , that is, the tip of the suction catheter 1 .

[0039] like Figure 1 As shown, the proximal end of the suction catheter 1 is provided with a filling interface 15 connected to the filling channel 13, a suction interface 16 connected to the suction channel 11, and an other equipment interface 17 connected to the suction channel 11, that is, the outlet of the proximal end of the filling channel 13 is connected to the filling interface 15, and the outlet of the proximal end of the suction channel 11 is respectively connected to the suction interface 16 and the other equipment interface 17. Preferably, the axis of the other equipment interface 17 coincides with the axis of the suction channel 11, so that other equipment can be easily entered.

[0040] A balloon 18 is fixedly provided at the distal end of the suction catheter 1, and the balloon 18 is connected to the distal outlet of the filling channel 13, so that the balloon 18 can be filled and released through the filling interface 15 and the filling channel 13, so that the balloon 18 has an open state and a retracted state. When the suction catheter 1 is implanted and recovered, the balloon 18 is in a retracted state, so as to facilitate the implantation and recovery of the suction catheter 1; when in use, the balloon 18 is in an open state, so that the outer diameter of the balloon 18 is greater than or equal to the inner diameter of the blood vessel, preferably the outer diameter of the balloon 18 is equal to or slightly greater than the inner diameter of the blood vessel, so that the blood vessel can be blocked, temporarily blocking the blood flow, and preventing the loosened free thrombus from drifting to other blood vessels during the thrombus removal process.

[0041] In this embodiment, the balloon 18 is located between the two outlets of the guide wire channel 12. Figure 1 As shown, the outlet of the proximal end of the guidewire channel 12 is opened on the tube wall of the suction catheter 1 , and the outlet is located at the front end of the balloon 18 .

[0042] In this embodiment, the suction catheter 1 is a catheter with three lumens. Of course, other multi-lumen catheters can also be used instead. The guidewire channel 12 of the suction catheter 1 can be used for OTW rapid exchange guidewires or central push guidewires to pass through, and is suitable for but not limited to 0.014" guidewires. While ensuring that the suction catheter 1 has the ability to suction thrombi, it also reserves passages for other equipment, so that it can deal with various complex thrombi.

[0043] like Figure 1 As shown, the occluding device includes an occluding catheter 31, and an occluding device 32 disposed at the distal end of the occluding catheter 31 and having an open state and a collapsed state. The occluding device 32 is a balloon that can be inflated by inflation of air or liquid.

[0044] When the occluder 32 is in the open state, the outer diameter of the occluder 32 is greater than or equal to the inner diameter of the blood vessel. Preferably, the outer diameter of the occluder 32 is equal to or slightly greater than the inner diameter of the blood vessel, so that the occluder 32 is attached to the inner wall of the blood vessel. When in use, the occluder 32 is located at the distal end of the suction catheter 1 and acts simultaneously with the balloon 18 of the suction catheter 1 to form a closed space in the blood vessel in a short time, so that the stirring device can drag the thrombus or perform thrombolysis to achieve good therapeutic effects. When the occluder 32 is in the closed state, the occluder can pass through the suction channel 11.

[0045] The stirring device includes a first sheath tube 41, a second sheath tube 42 slidably sleeved outside the first sheath tube 41, and a stirring assembly arranged at the distal end of the first sheath tube 41; the stirring assembly includes a stirrer 43 having an expanded state and a collapsed state, and the outer diameter of the stirrer 43 in the expanded state is less than or equal to the inner diameter of the blood vessel. When in use, the stirring assembly and the first sheath tube 41 are collapsed in the second sheath tube 42, the stirring device enters the suction channel 11 from the interface of other equipment and makes the stirrer 43 located between the suction catheter 1 and the occluder 32, the second sheath tube 42 is withdrawn, the stirrer 43 is opened, and the stirrer 43 moves back and forth in the blood vessel by dragging the first sheath tube 41 back and forth.

[0046] Implementation method 1:

[0047] like Figure 8 and Fig. 9 As shown, there is only one agitator 43, which is formed by several braided memory wires 44 and can achieve self-expansion by withdrawing the second sheath 42 toward the proximal end. When dragging the first sheath 41, the degree of adhesion of the memory wire 44 to the wall and the dragging force can be controlled by adjusting the degree of opening of the agitator 43 through the withdrawal length of the second sheath 42.

[0048] The first sheath tube 41 penetrates the stirrer 43 , and the axis of the first sheath tube 41 coincides with the center line of the stirrer 43 . The stirrer 43 is fixed to the first sheath tube 41 by welding or other processes.

[0049] The shape of the basket can be a commonly used shape in the prior art, such as a spherical shape, a shuttle shape, etc. The material of the memory wire 44 can be a memory alloy such as nickel-titanium alloy.

[0050] Implementation method 2:

[0051] The agitators 43 are multiple and are sequentially arranged along the axial direction of the first sheath tube 41. Fig.10 and Fig.11 As shown, there are two agitators 43 . Two adjacent agitators 43 are connected by an elastic member 45 so that the two adjacent agitators 43 can be relatively close to or far away from each other along the axial direction of the first sheath tube 41 .

[0052] like Figure 6 As shown, the elastic member 45 is integrally provided with the first sheath tube 41 , and the spring-like elastic member 45 is formed by spiral cutting on a section of the first sheath tube 41 .

[0053] When the elastic member 45 is in a stationary state (ie, the elastic member 45 is neither extended nor compressed), the distance between two adjacent agitators 43 is 5-10 mm.

[0054] The stirrer 43 is a basket made of memory wire 44, for example, made by laser cutting and heat setting of a nickel-titanium alloy tube. The stirrer 43 is spherical, and the diameter of the stirrer 43 is 9-14 mm.

[0055] like Figure 3 and Figure 4 As shown, the projection of the agitator 43 on a plane perpendicular to the axis of the first sheath tube 41 is in the shape of petals, and the number of petals can be set according to actual needs, preferably set to 4 to 6 petals, and 5 petals in this embodiment.

[0056] like Figure 5 As shown, the projections of the plurality of stirrers 43 on a plane perpendicular to the axis of the first sheath tube 41 are staggered, that is, the projections of the memory wires 44 of the plurality of stirrers 43 on the plane do not overlap.

[0057] The first sheath tube 41 penetrates the stirrer 43 , and the axis of the first sheath tube 41 coincides with the center line of the stirrer 43 . The stirrer 43 is fixed to the first sheath tube 41 by welding or other processes.

[0058] The thrombus removal system of the present invention further comprises a guide wire 2 and a thrombolytic tube. The improvement of the guide wire 2 and the thrombolytic tube is not the focus of protection of the present invention. The guide wire 2 and the thrombolytic tube in the prior art can be used.

[0059] The suction catheter 1, the blocking device, and the stirring device are packaged separately and can be equipped with separately packaged guide wire 2 and thrombolytic tube when sold, so as to facilitate medical staff to use the whole set.

[0060] Steps for using this thrombus removal system:

[0061] 1. Pass the guide wire 2 to the lesion site.

[0062] 2. Pass the guide wire 2 through the guide wire channel 12 to deliver the suction catheter 1 to the front end of the lesion site, and perform angiography to observe the blockage situation.

[0063] 3. The occluding device is inserted from the interface of other equipment, transported through the suction channel 11 and passed through the lesion site by the occluding device 32, and then the occluding device 32 is filled through the occluding catheter 31 to occlude the distal end of the blood vessel, and then the balloon 18 is filled through the filling interface 15 and the filling channel 13 to occlude the proximal end of the blood vessel, so that a short-term closed space is formed between the occluding device 32 and the balloon 18.

[0064] 4. The thrombolytic tube is inserted from the interface of other equipment and transported to the lesion site in the closed space through the suction channel 11. The thrombolytic tube performs thrombolysis in the special space. After the thrombolysis is completed, the thrombolytic tube is taken out.

[0065] 5. Insert the stirring device from the interface of other equipment, and transport it to the lesion site in the closed space through the suction channel 11, withdraw the second sheath tube 42 and open the stirrer 43.

[0066] 6. Grasp the first sheath tube 41 and drag it repeatedly, while applying negative pressure through the suction port 16 and the suction channel 11.

[0067] 7. After the insoluble thrombus is attached to the agitator 43, the first sheath tube 41 is withdrawn to extract the thrombus from the body.

[0068] 8. After the agitator 43 is completely removed, the suction catheter 1 is repeatedly suctioned to extract the remaining thrombus.

[0069] 9. After the thrombus removal is completed, the pressure on the occluder 32 and the balloon 18 is removed, and angiography is performed again to observe the treatment effect. If the thrombus is not completely removed, repeat the above steps until the thrombus is completely aspirated.

[0070] 10. After the treatment is completed, the suction catheter 1 is withdrawn along the guide wire 2, and then the occluder 32 is withdrawn.

[0071] The above steps are for treating old thrombi that are difficult to treat. For some thrombi that are easier to treat, steps such as thrombolysis with a thrombolytic tube can be omitted accordingly.

[0072] The present invention performs intervention through the guide wire 2, and the suction catheter 1 balloon 18 and the occluder 32 block the blood vessel when they are filled, which not only facilitates the doctor's surgical operation, but also increases the effect of catheter thrombolysis and prevents the thrombus from falling off and drifting to the heart during the thrombectomy. Using a large-sized suction catheter 1 in conjunction with an agitator 43 in the vein can effectively remove large areas of acute and subacute thrombi in the inferior vena cava. When dealing with old thrombi in the inferior vena cava, thrombolysis can be performed first, and then dragged into the suction catheter 1 through the agitator 43. The use of this device can remove a large amount of thrombi in the inferior vena cava while ensuring relative safety, protect the venous valves and venous blood vessel walls, controllable blood loss, simple operating steps, shortened operation time, and reduced patient hospitalization costs.

[0073] As mentioned above, we have described the invention in full accordance with the purpose of the invention, but the invention is not limited to the above embodiments and implementation methods. Practitioners in the relevant technical field can make different changes and implementations within the scope permitted by the technical concept of the invention.

Claims

1. A thrombus stirring device, characterized in that: It comprises a first sheath tube (41), a second sheath tube (42) slidably sleeved outside the first sheath tube (41), and a stirring assembly arranged at the distal end of the first sheath tube (41); the stirring assembly comprises a plurality of stirrers (43) arranged in sequence along the axial direction of the first sheath tube (41) and having a folded state and an expanded state, and two adjacent stirrers (43) are connected by an elastic member (45) so that the two adjacent stirrers (43) can be relatively close to or away from each other along the axial direction of the first sheath tube (41); when the stirrer (43) is in the folded state, the stirring assembly is located in the second sheath tube (42); when the stirrer (43) is in the expanded state, the stirring assembly is separated from the second sheath tube (42).

2. The thrombus stirring device according to claim 1, characterized in that: The elastic member (45) is a spring.

3. The thrombus stirring device according to claim 1, characterized in that: The elastic member (45) is integrally arranged with the first sheath tube (41).

4. The thrombus stirring device according to claim 1, characterized in that: When the elastic member (45) is in a stationary state, the distance between two adjacent agitators (43) is 5 to 10 mm.

5. The thrombus stirring device according to claim 1, characterized in that: The stirrer (43) is a mesh basket made of memory wire (44).

6. The thrombus stirring device according to claim 5, characterized in that: The projection of the stirrer (43) on a plane perpendicular to the axis of the first sheath tube (41) is in the shape of a petal.

7. The thrombus stirring device according to claim 5, characterized in that: The projections of the plurality of stirrers (43) on a plane perpendicular to the axis of the first sheath tube (41) are staggered.

8. The thrombus stirring device according to claim 1 or 5, characterized in that: The stirrer (43) is spherical.

9. The thrombus stirring device according to claim 8, characterized in that: The diameter of the stirrer (43) is 9 to 14 mm.

10. The thrombus stirring device according to claim 1, characterized in that: The first sheath tube (41) passes through the plurality of stirrers (43), and the axis of the first sheath tube (41) and the center lines of the plurality of stirrers (43) coincide with each other.

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