Intravascular rapid exchange split type thrombectomy device

Abstract

The invention relates to an intravascular rapid exchange split thrombectomy device which comprises a far-end guiding device and a near-end conveying device, the guiding device is formed by axially connecting a far-end guiding head and a near-end conveying wire, and the conveying device is of a tubular cavity structure formed by connecting a developing ring, a thrombectomy support and a conveying pipe. The guiding device and the conveying device are in axial plugging connection; the limiting section is axially arranged at the far end of the guiding head and connected with the conveying wire at the near end through the supporting section, the outer diameter of the limiting section is larger than the inner diameter of the developing ring, and the outer diameters of the supporting section and the conveying wire are smaller than the inner diameter of the developing ring; the far end of the conveying pipe is radially provided with a rapid exchange port. The guiding device and the conveying device are of a detachable structure, so that the problems that a thrombus extraction stent can reach an affected part only by using a micro catheter and a micro guide wire and thrombus capture can be carried out only by withdrawing the micro guide wire firstly are solved, and the problem that an operator needs to repeatedly convey the guide wire in place is solved; and the damage of the guide wire and the micro-catheter to the blood vessel of the patient in the surgical operation process is reduced.

Description

Technical Field

[0001] The present invention relates to an intravascular thrombectomy device, and particularly to a rapid-exchange split-type intravascular thrombectomy device, belonging to the technical field of medical devices. Background Art

[0002] Cardiovascular and cerebrovascular diseases are diseases that seriously threaten human health, especially common diseases among middle-aged and elderly people over 40 years old, characterized by high prevalence, high disability rate, and high mortality rate. According to domestic data, the annual direct treatment cost of cardiovascular and cerebrovascular diseases in China is more than 130 billion yuan, accounting for 22% of the total medical expenses in China. Four out of every 10 death cases are due to cardiovascular and cerebrovascular diseases. With the accelerating process of urbanization, the intensification of the aging problem, and the changes in lifestyle and diet structure in China, cardiovascular and cerebrovascular diseases have become the "main force" of chronic diseases in China.

[0003] The reconstruction of the blood pathway is the key to the treatment of acute ischemic stroke, and the rapid establishment of a vascular access is the key to the patient's recovery. The existing thrombectomy products all need to rely on a microcatheter and a microguide wire to achieve their thrombectomy function, and the most commonly used rapid-exchange technology in clinical practice cannot be used in thrombectomy surgery. The operation of the microguide wire and the microcatheter is complex and difficult to control, often wasting a lot of time when establishing a vascular access with the microguide wire and the microcatheter, and the patient loses the best treatment time window. Therefore, there is an urgent need in clinical practice for a rapid-exchange type thrombectomy product that can quickly establish a vascular access without complex operations such as a microcatheter and a microguide wire. Summary of the Invention

[0004] In order to solve the above problems, the present invention proposes a rapid-exchange split-type intravascular thrombectomy device, and the technical solution is as follows: A rapid-exchange split-type intravascular thrombectomy device includes a guiding device at the distal end and a delivery device at the proximal end. The guiding device is axially connected by a guiding head at the distal end and a delivery wire at the proximal end. The delivery device is a tubular cavity structure composed of a radiopaque ring, a thrombectomy stent, and a delivery tube connected. The guiding device and the delivery device are axially pluggable and detachable; the guiding head is a variable-diameter structure composed of a limiting section and a supporting section. The limiting section is axially arranged at the distal end and is connected to the proximal delivery wire through the supporting section. The outer diameter of the limiting section is larger than the inner diameter of the radiopaque ring, and the outer diameters of the supporting section and the delivery wire are smaller than the inner diameter of the radiopaque ring; a rapid-exchange port is radially arranged at the distal end of the delivery tube.

[0005] Further, the radiopaque ring includes a distal radiopaque ring and a proximal radiopaque ring, which are respectively axially fixed at both ends of the thrombectomy stent to facilitate observing the position of the thrombectomy stent in place. The inner diameter of the distal radiopaque ring is smaller than the outer diameter of the limiting section.

[0006] Further, the length of the supporting section and the delivery wire is greater than the length between the radiopaque ring and the rapid-exchange port.

[0007] Furthermore, the delivery wire is composed of a distal end of the delivery wire, a middle section of the delivery wire, and a proximal end of the delivery wire connected in sequence, and the surface of the delivery wire is coated with a coating.

[0008] Furthermore, the distal end and the proximal end of the delivery wire are of variable diameter structures, and the middle section of the delivery wire is of a constant diameter structure, meeting the requirements of good push force conduction and pushing performance.

[0009] Furthermore, the delivery tube is of a multi-layer braided structure.

[0010] Furthermore, the limiting section is a cylinder with a multi-layer structure. The inner layer is a wire winding structure with radiopacity, and the outer layer is made of a shape memory metal material. The shape memory metal has superelasticity, is not easily bent, prevents breakage, and has good flexibility, which can improve the ability of the product to pass through the diseased position.

[0011] Furthermore, the outer layer of the support section is a wire winding structure with radiopacity. The use of the wire winding structure can reduce the rigidity of the wire and can show the positions of the thrombectomy stent and the distal end of the guide wire.

[0012] Furthermore, the delivery wire axially penetrates and is arranged inside the guiding head, which can adjust the softness of the guiding head and can also prevent the limiting section of the guiding head from being stretched and extended.

[0013] Furthermore, a Luer connector is provided at the proximal end of the delivery tube.

[0014] Furthermore, the thrombectomy stent is a mesh structure woven from metal wire materials.

[0015] Compared with the prior art, its beneficial effects are as follows: The operation of the present invention is simple. The guiding device and the delivery device are detachable structures, which can be quickly combined and disassembled during use. After grasping the thrombus, the delivery device together with the thrombus is removed from the body, and the guiding device is left at the affected area, laying a good foundation for the angiography examination or secondary thrombectomy of the subsequent thrombectomy effect, avoiding the problems in the prior art that the thrombectomy stent must use a microcatheter and a microguide wire to reach the affected area and that the microguide wire needs to be withdrawn first during thrombus capture, solving the problem that the operator needs to repeatedly deliver the guide wire in place, and reducing the damage to the patient's blood vessels by the guide wire and the microcatheter during the surgical operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The features and advantages of the present invention will be obvious from the following detailed description of the embodiments of the present invention with reference to the accompanying drawings.

[0017] Figure 1 It is a schematic structural diagram of the compact state of the rapid exchange and detachable thrombectomy device in blood vessels; Figure 2 It is a schematic structural diagram of the expanded state of the rapid exchange and detachable thrombectomy device in blood vessels; Figure 3Schematic structural diagram of the delivery device of the intravascular rapid-exchange split thrombectomy device; Figure 4 Schematic structural diagram of the guiding device of the intravascular rapid-exchange split thrombectomy device; In the figure: 1. Guiding device, 2. Delivery device, 3. Guiding head, 3-1. Limiting section, 3-2. Supporting section, 4. Delivery wire, 4-1. Distal end of the delivery wire, 4-2. Middle section of the delivery wire, 4-3. Proximal end of the delivery wire, 5. Distal imaging ring, 6. Thrombectomy stent, 7. Rapid-exchange port, 8. Proximal imaging ring, 9. Delivery tube, 10. Luer connector, 11. Channel. Embodiment

[0018] Next, refer to Figures 1-4 to describe the embodiments of the present invention in detail. Embodiment

[0019] As Figures 1-3 shown, during treatment, the guiding device is pushed to reach the affected area, the proximal end of the guiding device is inserted into the delivery device through the distal imaging ring 5, so that the delivery wire 4 passes out through the rapid-exchange port, and the delivery device is continuously pushed distally. When the distal imaging ring 5 of the delivery device contacts the limiting section 3-1 of the guiding device, since the outer diameter of the limiting section 3-1 of the guiding device is larger than the inner diameter of the distal imaging ring 5, the limiting section 3-1 limits the distal imaging ring 5 and makes it no longer move distally. At this time, the delivery device is continuously pushed distally, and the thrombectomy stent 6 is pressurized by using the relative displacement between the guiding device and the delivery device and the limiting effect of the limiting section 3-1 to compress its axial length and make it in an expanded state. At this time, the thrombectomy stent 6 deforms, the axial length becomes shorter, the diameter becomes larger, and the mesh holes of the thrombectomy stent 6 also become larger, so that the thrombus enters the thrombectomy stent 6. At this time, the delivery device is retracted to relieve the pressure applied to the thrombectomy stent 6. Under the action of the shape memory metal, the thrombectomy stent 6 returns to a tightened state, the axial length returns to the original length, the diameter becomes smaller, and the mesh holes become smaller, so that the thrombus is wrapped by the thrombectomy stent 6, realizing the grasping of the thrombus. Embodiment

[0020] As Figures 1-3As shown, during treatment, the guide device is pushed to the affected area, the proximal end of the guide device is inserted into the delivery device through the distal development ring 5, the delivery wire 4 is passed through the quick exchange port, and the delivery device is pushed to the distal end. When the distal development ring 5 of the delivery device contacts the limiting segment 3-1 of the guide device, since the outer diameter of the limiting segment 3-1 of the guide device is larger than the inner diameter of the distal development ring 5, the limiting segment 3-1 limits the distal development ring 5 so that it no longer moves to the distal end. At this time, the guide device is withdrawn to the proximal end, and the relative displacement of the guide device and the delivery device and the limiting segment 3-1 are utilized. -1's limiting effect applies pressure to the thrombus retriever stent 6, compressing its axial length and changing it to an expanded state. At this time, the thrombus retriever stent 6 is deformed, the axial length becomes shorter, the diameter becomes larger, and the mesh of the thrombus retriever stent 6 also becomes larger, causing the thrombus to enter the thrombus stent 6. At this time, the guiding device is pushed toward the distal end to release the pressure applied to the thrombus retriever stent 6. Under the action of the memory metal, the thrombus retriever stent 6 returns to a contracted state, the axial length is restored to its original length, the diameter becomes smaller, and the mesh becomes smaller accordingly, so that the thrombus is wrapped by the thrombus retriever stent 6, thereby achieving the capture of the thrombus. Example

[0021] After grabbing the thrombus, the delivery device and the thrombus can be removed from the body, and the guide device can be kept in the affected area, laying a good foundation for subsequent angiographic examination of the thrombectomy effect or secondary thrombectomy. Example

[0022] The thrombus removal stent 6 is woven from metal wires of different materials and has development properties, shape memory and superelasticity. Example

[0023] The quick exchange port 7 is formed by a reserved opening on one side of the delivery tube 9 by laser cutting or during the delivery tube weaving process. Example

[0024] The limiting segment 3 - 1 has radial flexibility and its outer diameter is larger than the inner diameter of the distal marking ring 5 . Example

[0025] The guiding device 1 and the conveying device 2 are used in dependence on each other and exist independently. They can be quickly assembled and disassembled during use, and can be completed by a quick exchange method during the conveying and withdrawal process.

Claims

1. An intravascular rapid exchange split thrombectomy device, comprising a distal guiding device and a proximal delivery device. The guiding device is axially connected by a distal guiding head (3) and a proximal delivery wire (4). The delivery device is a tubular cavity structure composed of a radiopaque ring, a thrombectomy stent (6) and a delivery tube (9), characterized in that, The guiding device and the conveying device are axially pluggable; the guiding head (3) is a variable-diameter structure composed of a limiting section (3-1) and a supporting section (3-2). The limiting section (3-1) is axially arranged at the distal end and is connected to the conveying wire (4) at the proximal end through the supporting section (3-2). The outer diameter of the limiting section (3-1) is larger than the inner diameter of the imaging ring, and the outer diameters of the supporting section (3-2) and the conveying wire (4) are smaller than the inner diameter of the imaging ring; a quick-exchange port (7) is radially arranged at the distal end of the conveying tube (9).

2. The intravascular rapid exchange split thrombectomy device according to claim 1, characterized in that, The imaging ring includes a distal imaging ring (5) and a proximal imaging ring (8), which are respectively axially and fixedly arranged at both ends of the thrombectomy stent (6). The inner diameter of the distal imaging ring (5) is smaller than the outer diameter of the limiting section (3-1).

3. The intravascular rapid exchange split thrombectomy device according to claim 1, wherein The lengths of the supporting section (3-2) and the conveying wire (4) are greater than the length between the imaging ring and the quick-exchange port (7).

4. A rapid exchange split thrombectomy device within blood vessels according to claim 1, characterized in that, The conveying wire (4) is successively connected by a distal end of the conveying wire (4-1), a middle section of the conveying wire (4-2), and a proximal end of the conveying wire (4-1).

5. A rapid exchange split thrombectomy device for intravascular use according to claim 4, characterized in that, The distal end (4-1) and the proximal end (4-1) of the conveying wire are variable-diameter structures, and the middle section (4-2) of the conveying wire is an equal-diameter structure.

6. A rapid exchange split thrombectomy device for intravascular use according to claim 1, characterized in that, The conveying tube (9) has a multi-layer braided structure.

7. A rapid exchange split thrombectomy device for intravascular use according to claim 1, characterized in that, The limiting section (3-1) is a multi-layer cylindrical body, with an inner layer being a wire-winding structure with imaging property and an outer layer made of shape memory metal material.

8. A rapid exchange and split thrombectomy device for intravascular use according to claim 1, characterized in that The outer layer of the supporting section (3-2) is a wire-winding structure with imaging property.

9. A rapid exchange and split type thrombus removal device within blood vessels according to claim 1, characterized in that, The conveying wire (4) axially penetrates through the guiding head (3).

10. A rapid exchange and split thrombus extraction device within blood vessels according to claim 1, characterized in that, The thrombectomy stent (6) is a mesh structure woven from metal wire.

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