Safe Thrombectomy Device

Abstract

The safety thrombectomy device comprises: a handle 1; a hollow outer tube 2; a hollow inner core tube 3 having a first inner core segment within a through hole of the outer tube 2, a second inner core segment extending from a front end of the outer tube 2, and a third inner core segment extending from a rear end of the outer tube 2; a thrombus disrupter 5 provided at the front end of the outer tube 2; a thrombus collector 4 connected to the front end of the second inner core segment and disposed in front of the thrombus disrupter 5; a T-joint 6 provided at the front end of the handle 1 and having a free end 10 for injecting saline; an adjustment knob 7 provided on the handle 1 and moving relative to the handle 1 to drive the outer tube 2 to move back and forth; a locking knob 8 provided on the handle 1 and locking the adjustment knob 7 after the outer tube 2 has moved to a preset position; and an injector 9 provided at the rear end of the handle 1 for injecting saline into the third inner core segment of the hollow inner core tube 3.

Description

[Technical Field]

[0001] The present invention relates to medical devices, and more particularly to a safety thrombectomy device for removing thrombus from a human body by destroying and collecting the thrombus within the blood vessel of the human body. [Background technology]

[0002] Thrombosis is currently a common symptom in the cardiac and cerebral blood vessels of the human body and is extremely harmful to human health. The main treatment methods are drug-induced thrombolysis and thrombectomy. Currently, the commonly used method for removing thrombi is interventional therapy, in which a thrombus breaker and thrombus collector mounted on a flexible multi-layer hose is placed at the location of the thrombus through the blood vessel. The thrombus is broken into smaller clots by the thrombus breaker, then collected by the thrombus collector, and then removed from the human body. The above-mentioned thrombectomy device for thrombus breakage and thrombus collection has two drawbacks in its long-term use. First, air exists in the multi-layer hose of the thrombectomy device. When placed in the human body, air enters the blood vessels of the human body and forms bubbles, which are essentially similar to thrombi. As blood flows, the bubbles randomly enter some vascular locations and obstruct blood flow. The second problem is that smaller thrombus clots are generated during the thrombus disintegration process by the thrombus breaker. If the collection efficiency of the thrombus collector is not high, the smaller thrombus clots will escape from the collection mesh of the thrombus collector and flow into smaller blood vessels with the blood flow, forming new obstructions that are more difficult to handle or process, especially if they flow into the blood vessels of the brain, resulting in more serious consequences. The two drawbacks described above have existed for many years, and the two new obstructions described above cannot still be avoided even with careful operation by physicians. Therefore, how to solve the technical drawbacks of the prior art and how to improve the safety of thrombectomy devices remains of great importance. Summary of the Invention [Problem to be solved by the invention]

[0003] It is an object of the present invention to provide a thrombectomy device that has a high degree of safety. [Means for solving the problem]

[0004] The safety thrombectomy device of the present invention is a safety thrombectomy device comprising: a handle; a hollow outer tube; a hollow inner core tube having a first inner core segment located within a through-hole in the outer tube, a second inner core segment extending from a front end of the outer tube, and a third inner core segment extending from a rear end of the outer tube; a thrombus breaker provided at the front end of the outer tube; a thrombus collector connected to the front end of the second inner core segment of the hollow inner core tube and located in front of the thrombus breaker (5); and a T-joint provided at the front end of the handle, connected to the outer tube, and having a free end used for injecting physiological saline. an adjustment knob provided on the handle and connected to the outer tube via the T-joint, the adjustment knob being movable relative to the handle to drive the outer tube to move back and forth; a locking knob provided on the handle and used to lock the adjustment knob after the outer tube has moved to a preset position; and an injector provided on the third inner core segment of the hollow inner core tube provided at the rear end of the handle and used to inject saline. and wherein the second inner core segment of the hollow inner core tube extending from the front end of the outer tube passes continuously through the thrombus breaker and the thrombus collector and is connected to the front end of the thrombus collector, so that the thrombus breaker and the thrombus collector can be inflated or tightened when the adjustment knob is driven to move the outer tube back and forth. It is characterized by:

[0006] Preferably, the front end of the second inner core segment of the hollow inner core tube is connected to the first hollow metal ring and to the front end of the thrombus collector via the first hollow metal ring.

[0008] Preferably The handle includes a chute for moving the adjustment knob within the handle, and the front end of the adjustment knob extends from the front end of the handle and is connected to the T-joint (6).

[0009] Preferably, the front end of the thrombus disrupter is connected to the rear end of the thrombus collector by a restraining ring.

[0010] Preferably, the first hollow metal ring is connected to a hollow flexible pulling head in front of it.

[0011] Preferably, the safety thrombectomy device of the present invention further comprises a guide wire passing continuously through the hollow cavity of the hollow inner core tube, the hollow cavity of the first hollow metal ring, and the hollow cavity of the hollow flexible retraction head.

[0012] Preferably, the free end of the T-piece comprises a plugged end and the outer end of the syringe comprises a plugged end.

[0013] Preferably, the front end of the thrombus collector is fixedly connected to the front end of the hollow inner core tube, the rear end of the thrombus disrupter is connected to the front end of the outer tube, and the rear end of the thrombus collector is connected to the front end of the thrombus disrupter via a restraining ring.

[0014] Preferably, the thrombus collector has at least one convex ring at the axial center position of the collection mesh, and the diameter of the convex ring is 0.5 to 2 mm larger than the diameter of the remainder of the collection mesh.

[0015] Preferably, the knit density of the metal wire in the convex ring is greater than the knit density of the remainder of the collecting mesh.

[0016] Preferably, the thrombus collector has two convex rings in the collection mesh.

[0017] Preferably, the thrombus disrupter has a disruption mesh made of woven metal wire; The aforementioned The crushing mesh has a hollow cylindrical structure in the center, and both ends of the hollow cylindrical structure are conical. There are.

[0018] The thrombus removal device defined in the above-mentioned technical solution of the present invention, when in use, injects saline through the injector at the end of the T-joint and the end of the hollow inner core tube, evacuates the air between the hollow inner core tube and the outer tube and the air in the hollow through-hole of the hollow inner core tube, and then inserts it into the human body to crush, collect and extract the thrombus; at the same time, the thrombus collector with a special design can avoid the outflow of thrombus fragments, which greatly improves the safety of the thrombus removal device of the present invention and avoids the safety risks existing in the prior art. [Brief explanation of the drawings]

[0019] [Figure 1] 1 is a schematic diagram of the overall structure of an embodiment of the present invention; [Figure 2] FIG. 2 is a view of the thrombectomy device of FIG. 1 in use. [Figure 3] FIG. [Figure 4] FIG. 1 is an enlarged schematic view of a thrombus breaker and a thrombus collector. [Figure 5] FIG. 10 is an enlarged schematic diagram of the connection of the hollow inner core tube to the thrombus disruptor and thrombus collector. DETAILED DESCRIPTION OF THE INVENTION

[0020] A detailed description of specific embodiments of the present invention will be provided with reference to the accompanying drawings. It should be noted that the detailed description of the present invention is provided to facilitate understanding of the technical spirit of the present invention, and should not be construed as limiting the scope of the claims of the present invention.

[0021] Referring to Figures 1 to 5, the safety thrombectomy device of the present invention comprises a hollow outer tube 2; the hollow inner core tube 3 having a first inner core segment (31) located within a through-hole in the outer tube 2, a second inner core segment (32) extending from the front end of the outer tube 2, and a third inner core segment (33) extending from the rear end of the outer tube 2; a thrombus breaker 5 provided at the front end of the outer tube 2; a thrombus collector (4) connected to the front end of the second inner core segment (32) and located in front of the thrombus breaker 5; a T-joint 6 provided at the front end of the handle 1 and having a free end 10 used for injecting saline; an adjustment knob 7 provided on the handle 1 and movable relative to the handle 1 to drive the outer tube 2 to move back and forth; a locking knob 8 provided on the handle 1 and used to lock the adjustment knob 7 after the outer tube 2 has moved to a preset position; and a syringe 9 provided on the third inner core segment (33) provided at the rear end of the handle 1 and used for injecting saline.

[0022] As shown in FIG. 5, a hollow inner core extends from the front end of the outer tube 2. The second inner core segment (32) of the tube 3 passes through the thrombus disrupter 5 and the thrombus collector 4 in sequence and is connected to the front end of the thrombus collector 4, so that the thrombus disrupter 5 and the thrombus collector 4 can be expanded (as shown in FIG. 2) or tightened (as shown in FIG. 1) when the adjustment knob 7 drives the outer tube 2 to move back and forth. The front end of the second inner core segment (32) of the hollow inner core tube 3 is connected to the first hollow metal ring 16 and to the front end of the thrombus collector 4 via the first hollow metal ring 16.

[0023] 1 to 3, the outer tube 2 is connected to a T-joint 6, which is connected to an adjustment knob 7 via the T-joint 6. As shown in FIG. 3, the adjustment knob 7 includes a first portion disposed within the handle 1 chute and a second portion extending from the front end of the handle 1 and connected to the T-joint 6.

[0024] As shown in FIG. 5, the front end of the thrombus disrupter 5 is connected to the rear end of the thrombus collector 4 by a restriction ring 18, so that when the outer tube 2 moves back and forth, the thrombus disrupter 5 and the thrombus collector 4 can move together.

[0025] As shown in FIG. 5, the present invention also has a hollow flexible retracting head (15) connected to the first hollow metal ring (16), and a guide wire (not shown in the figure) for destroying the thrombus optionally extends through and out of the hollow cavity of the hollow inner core tube (3), the hollow cavity of the first hollow metal ring (16), and the hollow flexible retracting head (15).

[0026] In particular, the outer tube 2 is hollow so that it can move relative to the hollow inner core tube 3. There is a gap between the inner core tube 3 and the outer tube 2. The front end of the handle 1 The section includes a T-joint 6, the through-tube of which connects the outer tube 2 with the hollow inner core tube. The hollow inner core tube 3 includes a third inner core segment (33) and a third inner core segment (34) of the hollow inner core tube 3. The rear end of the third inner core segment (33) of the hollow inner core tube 3 is connected to an injector 9 and fixedly connected to the rear end of the handle 1. An adjustment knob 7 on the handle 1 controls the forward and backward displacement of the outer tube 2 and the hollow inner core tube 3, and a locking knob 8 can lock the adjustment knob 7 to the handle 1. Before the above-mentioned thrombectomy device is placed in a human blood vessel, saline is injected through the free end 10 of the T-joint 6 and the injector 9. The saline expels air in the gap between the outer tube 2 and the hollow inner core tube 3 and in the hollow channel of the hollow inner core tube 3. A sealing ring 14 is provided at the connection between the T-joint 6 and the adjustment knob 7 to prevent the saline from leaking. After the thrombectomy device is placed in a human blood vessel, the thrombus collector 4 and the thrombus disrupter 5 are deployed with the displacement of the outer tube 2 and delivered to the thrombectomy position in the blood vessel to perform the thrombectomy operation of disrupting and collecting. During the entire operation process, the air between the outer tube 2 and the hollow inner core tube 3 and the air in the hollow cavity of the hollow inner core tube 3 is discharged in advance, eliminating the possibility of air entering the human blood vessels, completely avoiding the possibility of forming new intravascular obstructions caused by air bubbles entering the human blood vessels, and greatly improving the safety of thrombectomy.

[0027] To further improve safety, the free end 10 of the T-joint 6 is provided with a plugging end, or / and the outer end of the injector 9 is provided with a plugging end (the plugging end is not shown in the figure), and the above-mentioned plugging end can close the opening of the free end 10 and the injection port of the injector 9 after saline is injected into the thrombectomy device to prevent the saline from flowing out, and the air that may be present when the thrombectomy device is operated repeatedly will re-enter the gap between the outer tube 2 and the hollow inner core tube 3 and the hollow cavity of the hollow inner core tube 3, ensuring the safety of the thrombectomy process.

[0028] The front end of the thrombus collector 4 includes a flexible introduction head 15 and a first metal ring 16. The flexible introduction head 15 is connected to the first metal ring 16, which is fixedly connected to the front end of the hollow inner core tube 3. The rear end of the thrombus breaker 5 is connected to the front end of the outer tube 2 and a second metal ring 17. The rear end of the thrombus collector 4 is connected to the front end of the thrombus breaker 5 via a restraining ring 18, which can be displaced along the hollow inner core tube 3. By displacing the outer tube 2 with the adjustment knob 7, the thrombus breaker 5 and the thrombus collector 4 can be released (expanded) or deflated. The thickness of the human blood vessel is monitored, and when the thrombus breaker 5 and the thrombus collector 4 are adapted to the diameter of the blood vessel, the locking knob 8 is rotated, so that the outer tube 2 can no longer be displaced axially, and the thrombus destruction operation can be performed. The thrombus collector 4 and thrombus disrupter 5 move together, which may allow better control over the degree of release and may facilitate operation.

[0029] In order to improve the development performance, at least three or more development rings 13 are arranged on the thrombus collector 4 and the thrombus disrupter 5, respectively, and the development rings 13 are made of a material that can be developed under X-ray irradiation, so that the actual expansion and contraction states of the thrombus collector 4 and the thrombus disrupter 5 can be clearly observed during the insertion of the thrombus collector 4 and the thrombus disrupter 5 into a human blood vessel.

[0030] In another embodiment, the hollow inner core tube 3 may continuously penetrate the first metal ring 16 and the hollow cavity of the flexible introducer head 15, and at least the first metal ring 16 may be fixedly connected to the first metal ring 16 so that when the contracted or clamped thrombus collector 4 and thrombus disrupter 5 as illustrated in FIG. 1 cannot penetrate the thrombus, the contracted or clamped thrombus collector 4 and thrombus disrupter 5 may penetrate a blood vessel having a thrombus to crush the thrombus using a guide wire (not shown) penetrating the hollow cavity of the hollow inner core tube 3.

[0031] During actual use, the thrombus disrupter 5 undergoes axial displacement and rotation, and the woven metal mesh of the thrombus disrupter 5 cuts the thrombus axially and radially. The resulting thrombus clots are collected by the collection mesh of the thrombus collector 4. To disrupt the thrombus, the thrombus collector 4 and the thrombus disrupter 5 must be repeatedly moved axially and / or rotationally, causing the collection mesh of the thrombus collector 4 to deform. This deformation can create gaps between the collection mesh and the vessel wall, allowing the disrupted thrombus clots to enter the vessel through the gaps. As blood circulates, the disrupted thrombus clots create new, smaller obstructions in the vessel. To prevent this, at least one convex ring 11 is provided at the location of the collection mesh of the thrombus collector 4. The diameter of the convex ring 11 is 0.5 to 2 mm larger than the diameter of the remaining collection mesh. Since the collecting net is formed by metal knitted wire, the collecting net has a certain elasticity in the radial direction, and when the collecting mesh is in the human blood vessel, the elastic deformation and elastic force experienced by the convex ring 11 is greater than that of the rest of the collecting net, and when the collecting net is axially displaced or rotated to produce integral deformation, the convex ring 11 has a larger radial deformation amount, so that the convex ring 11 maintains proper contact with the wall surface of the blood vessel, and the above-mentioned gap is avoided, thus preventing the destroyed thrombus clot from re-entering the blood circulation, and further improving the safety of the thrombectomy device.

[0032] In order to further improve safety, the knitting density of the metal wire of the above-mentioned convex ring 11 of the collecting net is greater than the knitting density of the rest of the collecting net, and the radial elasticity of the convex ring 11 is further appropriately improved, so that the above-mentioned gap is avoided, and there are two convex rings 11 in the collecting mesh, so that the plugging effect of the convex ring 11 is further improved.

[0033] The thrombus disrupter 5 is a crushing mesh made of woven metal wire. The crushing mesh includes a cylindrical central section, a front conical section located at the front end of the cylindrical central section, and a rear conical section located at the rear end of the cylindrical central section (see Figures 4 and 5). The woven wire in the front conical section cuts the thrombus axially, while the woven wire in the cylindrical central section primarily cuts the thrombus radially. The knitting density of the front conical section is greater than that of the rear conical section. To improve axial cutting of the thrombus, the front conical section includes a 1-2 mm flat section 12 located close to the edge of the cylindrical central section. The flat section 12 has a better cutting effect on the thrombus than the conventional circular woven wire. At the same time, the length of the flat section 12 is limited to 1-2 mm so as not to interfere with the overall deformation of the woven wire.

[0034] Although the present invention has been described in detail above, the present invention is not limited thereto, and various modifications can be made by those skilled in the art in accordance with the principles of the present invention. Therefore, the present invention is intended to include the modifications and variations of the present invention, provided that they fall within the scope of the appended claims and their equivalents.

Claims

1. 1. A safety thrombectomy device comprising: A handle (1); a hollow outer tube (2); a hollow inner core tube (3) having a first inner core segment (31) located within a through hole in the outer tube (2), a second inner core segment (32) extending from a front end of the outer tube (2), and a third inner core segment (33) extending from a rear end of the outer tube (2); a thrombus disruptor (5) provided at the front end of the outer tube (2); a thrombus collector (4) connected to the front end of the second inner core segment (32) of the hollow inner core tube (3) and located in front of the thrombus disrupter (5); a T-joint (6) provided at the front end of the handle (1) and connected to the outer tube (2), the T-joint (6) having a free end (10) used for injecting saline; an adjustment knob (7) provided at the handle (1) and connected to the outer tube (2) via the T-joint (6), which can be moved relative to the handle (1) to drive the outer tube (2) to move back and forth; a locking knob (8) provided on the handle (1) and used to lock the adjusting knob (7) after the outer tube (2) has moved to a preset position; a syringe (9) provided in the third inner core segment (32) of the hollow inner core tube (3) provided at the rear end of the handle (1) and used to inject saline; The second inner core segment (32) of the hollow inner core tube (3), extending from the front end of the outer tube (2), passes continuously through the thrombus breaker (5) and the thrombus collector (4) and is connected to the front end of the thrombus collector (4), so that the thrombus breaker (5) and the thrombus collector (4) can be inflated or tightened when the adjustment knob (7) drives the outer tube (2) to move back and forth.

2. A safety thrombus removal device as described in claim 1, characterized in that the front end of the second inner core segment (32) of the hollow inner core tube (3) is connected to a first hollow metal ring (16) and connected to the front end of the thrombus collector (4) via the first hollow metal ring (16).

3. A safety thrombus removal device as described in Claim 2, characterized in that the handle (1) is provided with a chute for moving the adjustment knob (7) within the handle (1), and the front end of the adjustment knob (7) extends from the front end of the handle (1) and is connected to the T-joint (6).

4. A safety thrombus removal device as described in claim 1, characterized in that the front end of the thrombus breaker (5) is connected to the rear end of the thrombus collector (4) by a regulating ring (18).

5. A safety thrombus removal device as described in claim 2, characterized in that the first hollow metal ring (16) is connected to a hollow flexible retracting head (15) located in front of it.

6. A safety thrombus removal device as described in Claim 5, further characterized in that it further comprises a guide wire that continuously passes through the hollow cavity of the hollow inner core tube (3), the hollow cavity of the first hollow metal ring (16), and the hollow cavity of the hollow flexible retracting head (15).

7. A safety thrombus removal device as described in claim 1, characterized in that the free end (10) of the T-joint (6) is provided with a plug-stop end.

8. A safety thrombus removal device as described in claim 1 or 7, characterized in that the outer end of the injector (9) is provided with a plug-stop end.

9. A safe thrombus removal device as described in claim 8, characterized in that the front end of the thrombus collector (4) is fixedly connected to the front end of the hollow inner core tube (3), the rear end of the thrombus disrupter (5) is connected to the front end of the outer tube (2), the rear end of the thrombus collector (4) is connected to the front end of the thrombus disrupter (5) via a restriction ring (18), and the thrombus collector (4) and the thrombus disrupter (5) are each provided with a development ring (13).

10. A safe thrombus removal device as described in Claim 9, characterized in that the thrombus collector (4) has at least one convex ring (11) at the axial center position of the collection mesh, and the diameter of the convex ring (11) is 0.5 to 2 mm larger than the diameter of the remainder of the collection mesh.

11. A safety thrombus removal device as described in Claim 10, characterized in that the knitting density of the metal wire of the convex ring (11) is greater than the knitting density of the remaining part of the collecting mesh.

12. A safety thrombus removal device as described in Claim 11, characterized in that the thrombus collector (4) has two convex rings (11) on the collection mesh.

13. A safe thrombus removal device as described in claim 1, characterized in that the thrombus breaker (5) has a crushing mesh made of woven metal wire, and the crushing mesh has a structure in which its center is a hollow cylindrical portion and both ends of the hollow cylindrical portion are conical portions.

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