Varicosity starting point plugging device and conveying system

Abstract

The invention discloses a varicosity starting point plugging device and a conveying system, and relates to the technical field of medical instruments, the plugging device comprises a balloon assembly, an elastic annular sleeve body and a clamping type wall locking mechanism; the multiple sets of clamping type wall locking mechanisms are distributed on the outer side of the elastic annular sleeve body at equal intervals in the circumferential direction, and the clamping type wall locking mechanisms are used for clamping the blood vessel wall; the balloon assembly is used for penetrating into the elastic annular sleeve body. The balloon assembly is used for filling, the elastic annular sleeve body is expanded and expanded, the clamping type wall locking mechanism is driven to be opened, then the balloon assembly is withdrawn, the plugging device is released, the elastic annular sleeve body drives the clamping type wall locking mechanism to clamp the blood vessel wall through resilience force, and therefore the clamping type wall locking mechanism is pulled and gathered to the position close to the middle of the elastic annular sleeve body, and the blood vessel is plugged. Permanent ligation plugging is achieved, releasing is achieved in an interventional mode, and harm to a patient can be reduced.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a varicose vein starting point occlusion device and delivery system. BACKGROUND

[0002] Varicose veins are the most common manifestation of chronic venous disease, characterized by abnormal dilation and tortuosity of the lower extremity superficial veins, resembling "worm-like". The disease is mainly caused by venous valve insufficiency, blood stasis and weak venous wall, and needs to be treated by relevant minimally invasive surgery.

[0003] Currently, thermal ablation or normal temperature ablation technology is mainly used in the treatment of varicose veins by minimally invasive surgery; however, in the clinical treatment process, whether it is thermal ablation therapy or normal temperature ablation therapy, the starting point of the treatment position in the operation needs to be kept a certain distance from the saphenous femoral junction to prevent damage to the femoral vein; and it is just because of the reserved distance that thrombosis and incomplete occlusion may occur, resulting in clinical complications such as pulmonary embolism.

[0004] However, there is currently no good occlusion device in the prior art that can safely and effectively permanently ligate and occlude the starting end of the great saphenous vein before varicose vein ablation, thereby not being convenient for improving the success rate of varicose vein ablation and reducing the occurrence of clinical complications such as pulmonary embolism. Although some occlusion devices can occlude the corresponding position of the blood vessel, they are not convenient to release and remain in the blood vessel, resulting in poor operation and use effect. SUMMARY

[0005] The present application aims to provide a varicose vein starting point occlusion device and delivery system to solve the technical problem of safe and effective permanent ligation and occlusion of the starting point of varicose veins in the prior art.

[0006] The technical problem solved by the present application can be achieved by the following technical solutions:

[0007] A varicose vein starting point occlusion device, comprising a balloon assembly, an elastic ring-shaped sleeve and a clamping type lock wall mechanism;

[0008] The clamping type lock wall mechanism is provided in multiple groups and is distributed equidistantly in the circumferential direction outside the elastic ring-shaped sleeve, and is used to clamp the blood vessel wall; the balloon assembly is used to penetrate into the inside of the elastic ring-shaped sleeve; the balloon assembly expands the elastic ring-shaped sleeve by inflation, and the clamping type lock wall mechanism is synchronously opened;

[0009] Preferably, the elastic ring-shaped sleeve comprises an elastic telescopic occlusion member and an elastic metal sleeve, the elastic telescopic occlusion member is provided in two groups and is arranged at both ends of the elastic metal sleeve, and the diameter of the elastic metal sleeve gradually decreases from both ends to the middle.

[0010] Preferably, the elastic telescopic blocking piece comprises an elastic telescopic blocking net and an elastic telescopic ring, the elastic telescopic blocking net is correspondingly connected at the port of the elastic metal sleeve body, and a silica gel film is covered on the elastic telescopic blocking net, and the elastic telescopic ring is connected at the center position of the elastic telescopic blocking net.

[0011] Preferably, the elastic telescopic blocking net and the elastic metal sleeve body are both made of a memory alloy material.

[0012] Preferably, the elastic metal sleeve body is connected with elastic blocking telescopic rings at the edge positions of both ends.

[0013] Preferably, the elastic blocking telescopic rings and the elastic telescopic ring are both made of silica gel.

[0014] Preferably, the clamping type lock wall mechanism comprises clamping arms, two clamping arms are arranged and fixedly connected at the upper and lower edges of the elastic metal sleeve body, and the clamping arms are fixedly connected with the elastic metal sleeve body.

[0015] Preferably, the end of each clamping arm is provided with an anti-dropping barb.

[0016] Preferably, the balloon assembly comprises a balloon catheter and an expansion balloon, the expansion balloon is connected around the balloon catheter, and the end of the balloon catheter is provided with a catheter head.

[0017] A delivery system comprises a delivery pipe, a locking joint and a delivery pipe joint, the delivery pipe is used for assembling the blocking device, the delivery pipe joint is connected to one end of the delivery pipe, the locking joint is arranged in cooperation with the delivery pipe joint, and the locking joint is used for locking the balloon assembly.

[0018] The present application has the following advantages:

[0019] 1. The balloon assembly and the elastic annular sleeve are sent to the blood vessel position to be blocked by the delivery system and are released, the elastic annular sleeve is expanded and opened by the inflation of the balloon assembly, the clamping type lock wall mechanism is opened, the balloon assembly is withdrawn, the blocking device is released, the clamping type lock wall mechanism is clamped by the elastic annular sleeve relying on the elastic force, the blood vessel wall is gathered and pulled to the middle position of the elastic annular sleeve, permanent ligation and blocking are realized, the release is realized by intervention, the harm to the patient is reduced, and the elastic annular sleeve can stretch and contract with the human body activity in the blood vessel and adapt to the change of the blood vessel.

[0020] 2. The elastic metal sleeve of the elastic annular sleeve is respectively provided with an elastic telescopic blocking net and an elastic telescopic ring at both ends, the elastic telescopic blocking net and the elastic telescopic ring are convenient for passing through the guide wire and assembling the balloon assembly, the elastic telescopic blocking net can deform with the deformation of the balloon assembly, and the elastic telescopic blocking net can restore when the balloon assembly is withdrawn, so that the both ends of the elastic metal sleeve are blocked.

[0021] 3、The clamping arms of the clamping type lock wall mechanism are opened along with the deformation of the side wall of the elastic metal sleeve body when the elastic metal sleeve body is expanded, and the clamping arms can be reset when the elastic metal sleeve body restores. Since the clamping arms are distributed on the upper and lower edges of the elastic metal sleeve body in pairs, the blood vessel wall can be clamped and gathered in the middle during the process, and ligation and occlusion are achieved. BRIEF DESCRIPTION OF DRAWINGS

[0022] Figure 1 is a schematic diagram of the overall structure of the present application;

[0023] Figure 2 is a schematic diagram of the state of the elastic metal sleeve body expanded after the inflation of the expansion balloon;

[0024] Figure 3 is a schematic diagram of the cross-sectional structure of the elastic metal sleeve body cooperating with the expansion balloon after the inflation of the expansion balloon;

[0025] Figure 4 is a schematic diagram of the state of the blood vessel ligation and occlusion by the packaging device of the present application;

[0026] Figure 5 is Figure 4 is an enlarged structural schematic diagram of position A in FIG. 6;

[0027] Figure 6 is a structural schematic diagram of one embodiment of the elastic telescopic occlusion net of the present application;

[0028] Figure 7 is a structural schematic diagram of the movable polygonal member employed in another embodiment of the elastic telescopic occlusion net of the present application;

[0029] Figure 8 is a structural schematic diagram of a delivery system of the present application.

[0030] BRIEF DESCRIPTION OF DRAWINGS

[0031] 1, elastic occlusion telescopic ring; 2, elastic telescopic occlusion net; 3, elastic metal sleeve body; 4, clamping arm; 5, anti-disengagement barb; 6, elastic telescopic ring; 7, balloon catheter; 8, expansion balloon; 9, catheter head; 10, locking joint; 11, delivery tube; 12, delivery tube joint; 13, single piece. DETAILED DESCRIPTION

[0032] The specific embodiments of the present application are described in detail below, but it should be understood that the scope of protection of the present application is not limited by the specific embodiments.

[0033] As Figures 1-7As shown, a varicose vein starting point occlusion device is used for endoluminal ligation and occlusion of the starting end of the great saphenous vein before varicose vein ablation. The occlusion device comprises a balloon assembly, an elastic ring sleeve and a clamping lock wall mechanism. The clamping lock wall mechanism is provided in multiple groups and is distributed equidistantly on the outside of the elastic ring sleeve in the circumferential direction. The clamping lock wall mechanism is used to clamp the blood vessel wall. The balloon assembly is used to penetrate into the inside of the elastic ring sleeve. The balloon assembly expands the elastic ring sleeve by inflation, and the clamping lock wall mechanism is synchronously opened to facilitate contact with the blood vessel wall.

[0034] That is, after the elastic ring sleeve is assembled with the balloon assembly and sent to the blood vessel lesion position, the balloon assembly can be inflated with water to expand the elastic ring sleeve, so that the clamping lock wall mechanism is opened and contacts the blood vessel wall. Then the water in the balloon assembly is recovered to realize the shrinkage and recovery of the balloon assembly. During this process, the elastic ring sleeve is recovered to reset the clamping lock wall mechanism. The clamping lock wall mechanism clamps the blood vessel wall and pulls it close to the middle position of the elastic ring sleeve to achieve ligation and occlusion.

[0035] It should be noted that the original size of the entire occlusion device is smaller than the size of the blood vessel.

[0036] In some specific embodiments, in combination with Figure 1 and Figure 2 As shown, the elastic ring sleeve comprises an elastic telescopic occlusion member and an elastic metal sleeve 3. The elastic telescopic occlusion member is provided in two groups and is arranged at both ends of the elastic metal sleeve 3. The diameter of the elastic metal sleeve 3 gradually decreases from both ends to the middle, that is, the initial state is that the two ends are thick and the middle is thin. The whole has elasticity. When the balloon assembly is inflated from the inside of the elastic metal sleeve 3, the entire elastic metal sleeve 3 can be expanded, and the inwardly concave curved side wall of the elastic metal sleeve 3 is stretched out.

[0037] In some specific embodiments, the elastic telescopic occlusion member comprises an elastic telescopic occlusion net 2 and an elastic telescopic ring 6. The elastic telescopic occlusion net 2 is connected to the port of the elastic metal sleeve 3 in correspondence. A silicone film is covered on the elastic telescopic occlusion net 2. The elastic telescopic occlusion net 2 has a through hole at the center position. The elastic telescopic ring 6 is connected at the center position of the elastic telescopic occlusion net 2. When the elastic telescopic ring 6 is in the initial state, it can basically ensure that the center position of the elastic telescopic occlusion net 2 is closed to prevent blood from passing through.

[0038] When the occlusion device is delivered to the blood vessel lesion site, the balloon assembly is first inserted into the elastic metal sleeve 3 through the center of the elastic telescopic occlusion net 2, and after reaching the lesion site, the balloon assembly is inflated to expand the elastic metal sleeve 3, and the elastic telescopic ring 6 and the elastic telescopic occlusion net 2 are also expanded synchronously due to the inflation of the balloon assembly, so as to avoid interfering with the inflation of the balloon assembly. When the balloon assembly is withdrawn, the elastic telescopic occlusion net 2 and the elastic telescopic ring 6 are elastically reset to ensure that the two ends of the elastic metal sleeve 3 are closed to prevent blood from passing through.

[0039] In some specific embodiments, the elastic telescopic occlusion net 2 and the elastic metal sleeve 3 are both made of a memory alloy material, such as nickel-titanium alloy, and the two can be connected by laser welding.

[0040] In some specific embodiments, the elastic metal sleeve 3 is connected with the elastic occlusion telescopic ring 1 at the edge positions of the two ends, so that the elastic metal sleeve 3 can be in safe contact with the blood vessel wall.

[0041] In addition, the elastic occlusion telescopic ring 1 can also be connected with the elastic telescopic occlusion net 2.

[0042] In some specific embodiments, the elastic occlusion telescopic ring 1 and the elastic telescopic ring 6 are both made of silicone, and can be connected by silicone shaping when connected.

[0043] In some specific embodiments, the elastic telescopic occlusion net 2 is woven by single-strand nickel-titanium alloy wires of different wire diameters, and the wire diameters can be 0.08, 0.1, 0.12, 0.15, 0.18, 0.25, 0.5 mm, etc. The occlusion net woven by nickel-titanium alloy wires with smaller wire diameters can have a larger telescopic size change and better support performance, and is suitable for small blood vessels. Conversely, the occlusion net woven by nickel-titanium alloy wires with larger wire diameters can be customized according to the diameter of the diseased blood vessel. In addition, the weaving method of the elastic telescopic occlusion net 2 can also be customized according to the diameter and elasticity of the diseased blood vessel. The weaving density can also be changed from the outer ring to the inner ring, and the change range can be 95 to 125 PPI, which can be continuously adjusted.

[0044] In some specific embodiments, as shown in Figure 6 The elastic telescopic occlusion net 2 includes a plurality of multi-edge telescopic occlusion rings with a stepped change in size, and the multi-edge telescopic occlusion rings are distributed one by one from the outside to the inside, and adjacent multi-edge telescopic occlusion rings are welded by nickel-titanium wires.

[0045] In some other specific embodiments, as shown in Figure 7As shown, the elastic expansion blocking net 2 comprises multiple sets of movable polygonal members, each set of movable polygonal members comprises multiple single pieces 13, preferably four single pieces 13, and the adjacent single pieces 13 are connected by riveting connection and can be deflected relative to each other, and then the movable polygonal members are arranged and connected based on the overall shape of the elastic expansion blocking net 2 to form a scalable net-shaped body.

[0046] In some specific embodiments, in combination with Figure 1 and Figure 2 , the clamping type lock wall mechanism comprises clamping arms 4, two clamping arms 4 are provided and fixedly connected at the upper and lower edges of the elastic metal sleeve body 3, the clamping arms 4 are rigidly fixedly connected with the elastic metal sleeve body 3, and the connection position can be a certain size surface.

[0047] Before the elastic metal sleeve body 3 deforms, the upper and lower clamping arms 4 are in a vertical position and are in a parallel state with the axis of the elastic metal sleeve body 3, when the elastic metal sleeve body 3 deforms and expands, the inwardly concave curved side wall gradually approaches the vertical position, thereby driving the upper and lower clamping arms 4 rigidly connected therewith to deflect and achieve the opening action, when the elastic metal sleeve body 3 restores, the two clamping arms 4 clamp each other, facilitating clamping of the blood vessel wall.

[0048] In some specific embodiments, the end of each clamping arm 4 is provided with a anti-disengagement barb 5, which facilitates embedding into the intima layer of the blood vessel wall, thereby facilitating clamping and locking of the blood vessel wall by the clamping arm 4.

[0049] It should be noted that the end of the anti-disengagement barb 5 can be treated to be non-sharp to avoid excessive damage to the blood vessel wall.

[0050] In some specific embodiments, in combination with Figure 2 and Figure 3 As shown, the balloon assembly comprises a balloon catheter 7 and an expansion balloon 8, the expansion balloon 8 is connected around the balloon catheter 7, the expansion balloon 8 is in communication with the balloon catheter 7, the balloon catheter 7 can be connected with a syringe to inject water into the expansion balloon 8; the end of the balloon catheter 7 is provided with a catheter head 9, the catheter head 9 can be in the shape of a cone for easy puncture or advancement, and the balloon catheter 7 and the catheter head 9 can both pass through a guide wire and move along the guide wire.

[0051] It should be noted that in order to effectively expand the expansion balloon 8 when it is inside the elastic metal sleeve body 3, the expansion balloon 8 can be provided in the shape of a shuttle with smaller sizes at both ends and a larger size in the middle, so that after inflation, the elastic metal sleeve body 3 can be effectively expanded.

[0052] In addition, it should be noted that the materials of the components used in each of the above blocking devices are harmless medical safety materials that can be left in the human body, facilitating permanent retention in the human body and not causing any health hazards to the human body.

[0053] A conveying system, such as Figure 8 As shown, it includes a delivery tube 11, a locking connector 10, and a delivery tube connector 12. The delivery tube 11 is used to assemble the delivery occlusion device. The delivery tube connector 12 is connected to one end of the delivery tube 11. The locking connector 10 is configured to cooperate with the delivery tube connector 12 and is used to lock the balloon assembly. The delivery tube 11 carries the occlusion device to the vascular lesion site, and then the occlusion device is released and the ligation and occlusion operation is performed.

[0054] To facilitate understanding of the embodiments of this solution by those skilled in the art, the working principle of this solution will now be briefly explained in conjunction with specific application scenarios:

[0055] First, the balloon catheter 7, carrying the uninflated balloon 8, is inserted into the elastic metal sleeve 3. Then, the whole thing is pressed and assembled into the delivery fitting 11. After the balloon catheter 7 is inserted into the delivery fitting 11, the locking connector 10 and the delivery fitting 12 are tightened.

[0056] The delivery tube 11 is inserted into the blood vessel with the help of the guide wire, the locking is released, the locking connector 10 is removed, and the balloon catheter 7 is pushed distally. The balloon catheter 7 and the elastic metal sheath 3 are pushed out of the delivery tube 11 together. The position of the elastic metal sheath 3 is adjusted with the help of the radiation equipment.

[0057] After reaching the location to be blocked, water is injected into the expansion balloon 8 through the balloon catheter 7 to complete the balloon inflation; after the balloon is inflated, the elastic metal sleeve 3 is opened, and as the elastic metal sleeve 3 deforms and opens, the inwardly concave curved sidewall gradually approaches the vertical position, thereby driving the clamping arms 4 rigidly connected on the upper and lower sides to deflect, realizing the opening action and contacting the blood vessel wall.

[0058] Then, the water in the dilation balloon 8 is completely recovered using a syringe. The dilation balloon 8 deflates and is withdrawn from the inside of the elastic metal sheath 3. The blood vessel wall rebounds, the elastic metal sheath 3 returns to its original state, and the two clamping arms 4 clamp each other to easily clamp the blood vessel wall and pull it together to a position close to the middle of the elastic metal sheath 3 to achieve ligation and closure.

[0059] The above-disclosed embodiments are merely a few specific examples of the present invention. However, the embodiments of the present invention are not limited thereto, and any variations that can be conceived by those skilled in the art should fall within the protection scope of the present invention.

Claims

1. A varix initiation point occlusion device, comprising: The device comprises a balloon assembly, an elastic ring-shaped sleeve and a clamping type lock wall mechanism. The clamping type lock wall mechanism is provided in multiple sets and is distributed equidistantly in the circumferential direction outside the elastic ring-shaped sleeve, and is used for clamping the blood vessel wall; the balloon assembly is used for penetrating into the inside of the elastic ring-shaped sleeve; the balloon assembly expands the elastic ring-shaped sleeve by inflation, and the clamping type lock wall mechanism is synchronously opened.

2. A varix initiation point occlusion device according to claim 1, wherein, The elastic ring-shaped sleeve comprises elastic telescopic blocking members and an elastic metal sleeve (3), the elastic telescopic blocking members are provided in two sets and are arranged at two ends of the elastic metal sleeve (3) respectively, and the diameter of the elastic metal sleeve (3) gradually decreases from the two ends to the middle.

3. A varix initiation point occlusion device according to claim 2, wherein, The elastic telescopic blocking members comprise elastic telescopic blocking nets (2) and elastic telescopic rings (6), the elastic telescopic blocking nets (2) are correspondingly connected at the ports of the elastic metal sleeve (3), and the elastic telescopic blocking nets (2) are covered with a silica gel coating film, and the elastic telescopic rings (6) are connected at the central positions of the elastic telescopic blocking nets (2).

4. A varix initiation point occlusion device according to claim 3, wherein, The elastic telescopic blocking nets (2) and the elastic metal sleeve (3) are both made of memory alloy material.

5. A varix initiation point occlusion device according to claim 3, wherein, The elastic metal sleeve (3) is connected with elastic blocking telescopic rings (1) at the edge positions of the two ends.

6. A varix initiation point occlusion device according to claim 5, wherein, The elastic blocking telescopic rings (1) and the elastic telescopic rings (6) are both made of silica gel material.

7. A varix initiation point occlusion device according to claim 2, wherein, The clamping type lock wall mechanism comprises clamping arms (4), the clamping arms (4) are provided in two sets and are fixedly connected at the upper and lower edges of the elastic metal sleeve (3), and the clamping arms (4) are fixedly connected with the elastic metal sleeve (3).

8. A varix initiation point occlusion device according to claim 7, wherein, The distal ends of the clamping arms (4) are provided with anti-disengagement barbs (5).

9. The varix initiation point occlusion device of claim 1, wherein, The balloon assembly comprises a balloon catheter (7) and an expansion balloon (8), the expansion balloon (8) is connected around the balloon catheter (7), and the distal end of the balloon catheter (7) is provided with a catheter head (9).

10. A delivery system for delivering a varicose vein initiation point closure device according to any one of claims 1 to 9, characterized in that The device comprises a delivery tube (11), a locking joint (10) and a delivery tube joint (12), the delivery tube (11) is used for assembling the blocking device, the delivery tube joint (12) is connected to one end of the delivery tube (11), the locking joint (10) is arranged in cooperation with the delivery tube joint (12), and the locking joint (10) is used for locking the balloon assembly.

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