Artery plugging device

Abstract

The utility model provides an artery plugging device. The artery plugging device comprises an operating handle, a hollow catheter, a metal framework, a plugging film, a traction structure and a guide device, the operating handle freely adjusts the unfolding size of the plugging device by controlling unfolding or folding of the metal framework and the plugging film to adapt to target blood vessels with different diameters, and therefore the plugging function is achieved. According to the artery plugging device, the plugging effect and adaptability are improved, the production technology is optimized, the production cost is reduced, wounds to blood vessels are reduced, the recovery time is shortened, the occurrence rate of complications is reduced, the structure is simple, the requirement for materials is low, and the technology is easy to achieve.

Description

Technical Field

[0001] The utility model relates to the field of artery packaging, in particular to an artery occluding device. Background Art

[0002] The existing arterial occlusion technology is mainly resuscitative balloon occlusion of the aorta (REBOA), which can be used to treat non-compressive traumatic trunk bleeding. Reports in recent years have shown that this technology and related medical devices can also be used to treat traumatic bleeding, non-traumatic abdominal bleeding, postpartum hemorrhage, placenta accreta spectrum (PAS) and cardiopulmonary resuscitation (CPR), etc., with great clinical significance and increasingly wide applicability.

[0003] The existing artery occlusion device mainly uses a balloon catheter, that is, an inflatable balloon is set at the distal end of the catheter, the balloon is sent to the target position of the artery through the catheter, and then fluid is injected into the balloon through the catheter to make the balloon inflated and fit tightly with the arterial wall, thereby achieving the purpose of occlusion. However, the existing balloon catheter has the following disadvantages:

[0004] Compliance balloons are prone to exceed safety dimensions as pressure increases during clinical use, causing balloon rupture or damage to the arterial wall;

[0005] Non-compliant and semi-compliant balloons need to be pre-designed in terms of their inflation size to accommodate different vascular specifications, which increases production costs and surgical preparation time. In the case of inappropriate size selection, it can also reduce the occlusion effect and safety.

[0006] The balloon is prone to rupture due to operational errors or conditions such as atherosclerosis. On the one hand, this causes product failure, and on the other hand, it also causes a certain impact on the patient's blood vessels, and may even cause complications such as thrombosis and foreign body embolism.

[0007] In terms of convenience, the balloon must be injected with sufficient liquid when used. In trauma scenarios, the product is not used within medical institutions and must be used with injection fluid, which will limit the use of the product. In addition, effective occlusion requires the injection of sufficient liquid, which requires a long operation time. For trauma scenarios where every second counts, it may lead to delayed treatment and bleeding complications.

[0008] In addition to arterial occlusion devices, in other technical fields such as vascular closure devices (VCD), there are occlusion devices other than balloons, such as the use of closable or expandable metal meshes to achieve the purpose of blocking blood flow from vascular wounds out of blood vessels.

[0009] However, the occluding device of such a vascular closure device lacks distal fixation and cannot ensure coaxiality with the target blood vessel. Therefore, the occluding device may deflect and fail to completely block blood flow in the cross section, resulting in incomplete vascular occlusion.

[0010] In addition, the size of the occluding device of this type of vascular closure device is fixed and cannot be adjusted accordingly according to the target vascular occlusion diameter. Similarly, this requires pre-designing its filling size to adapt to different vascular specifications, which increases production costs and surgical preparation time. If the size is not selected appropriately, it will also reduce the occlusion effect and safety.

[0011] Therefore, the existing technology, whether it is a balloon-based occlusion device or a non-balloon-based occlusion device, cannot meet the clinical demand for an arterial occlusion device, and a safer, more effective and convenient arterial occlusion device is needed.

[0012] Therefore, in order to solve the shortcomings of the prior art, such as high production cost, long surgical preparation time, reduced occlusion effect and poor safety, it is urgently necessary to provide a safe, effective and convenient arterial occlusion device that meets the requirements of low production cost, low complication rate and easy use. Utility Model Content

[0013] The purpose of the utility model is to solve the shortcomings of the prior art, such as high production cost, long operation preparation time, reduced occlusion effect and poor safety, and to provide a diameter-controllable artery rapid occlusion device, which can freely adjust the expansion size of the occlusion device according to different blood vessel diameters and occlusion requirements, has simple operation, good occlusion effect and high safety.

[0014] In order to achieve this purpose, the utility model provides an artery occlusion device, which includes an operating handle, a hollow catheter, a metal frame, an occlusion film, a traction structure and a guide device from the proximal end to the distal end; wherein:

[0015] An operating handle used to control the expansion or contraction of the metal frame;

[0016] A hollow catheter, the distal end of which is connected to the metal skeleton and the occluding device, and the proximal end of which is connected to the operating handle;

[0017] The metal frame can adjust the size of the occlusion device by expanding and contracting;

[0018] A blocking film is covered on the outside of the metal frame to achieve a blocking function;

[0019] A traction structure, a proximal end of which is connected to the operating handle;

[0020] The guide device is located at the distal end of the artery occluding device, and its proximal end is fixed to the distal end of the metal frame.

[0021] The operating handle includes a movable part and a fixed part; the traction structure is pushed toward the distal end or pulled toward the proximal end by operating the movable part of the operating handle, thereby driving the distal end of the metal skeleton and the film to move, thereby realizing the expansion or contraction of the occluding device.

[0022] The proximal end of the hollow catheter is connected to the fixed part of the operating handle. The proximal end of the traction structure extends through the inner cavity of the hollow catheter to the operating handle and is connected to the movable part of the operating handle.

[0023] The fixed part and the movable part of the operating handle are matched with threads to achieve fine control of the diameter of the blocking part, and a stepped buckle design can also be used.

[0024] The pulling structure may terminate at the proximal end of the movable portion of the operating handle, or may extend completely through the movable portion.

[0025] The guide device provides guidance and support during catheter delivery, and can also ensure the coaxiality of the device and the target blood vessel during deployment, ensuring that the occluding film fits the inner cavity of the target blood vessel.

[0026] The metal frame structure is a woven mesh structure, a lantern frame structure, a basket-shaped structure or a spiral structure. The metal frame material is nickel-titanium alloy. The length of the metal frame is 10-40 mm, and the length of the metal frame is preferably 30-40 mm.

[0027] The blocking film is made of polymer material.

[0028] The length of the guide device is 2-15 cm. The length of the guide device is 10-15 cm when used in the aorta and 5-10 cm when used in the peripheral artery.

[0029] The head of the guide device is designed to be a straight line with a smooth head end, one of a "J" type, a "P" type or a spiral shape. The structure and material design of the guide device are the same as those of the medical guide wire to play a better guiding role.

[0030] The traction structure may stop at the distal end of the metal frame, or may extend into the interior of the guide device and stop at the head end of the guide device.

[0031] The hollow catheter is made of metal, polymer material or a metal and polymer composite material.

[0032] Thin-walled metal tubes can be used as hollow conduits.

[0033] The operating handle part can be controlled to have an outer diameter of 3Fr, and can enter the blood vessel through a 3-4Fr vascular sheath.

[0034] The beneficial effects of the utility model are that the device of the utility model can freely adjust the unfolding size of the occluding device according to different blood vessel diameters and occluding requirements, adapt to target blood vessels of different diameters, simplify or eliminate the step of selecting a suitable instrument before surgery, and improve the occluding effect and adaptability; the structure of the metal skeleton and the occluding film is adopted, and there is no need to inflate or inject liquid. The connection strength, air tightness and water tightness requirements between the various components of the product are lower than those of the balloon, which optimizes the production process and reduces the production cost; there is no need to inflate or inject liquid, and it is not easy to rupture or damage the blood vessel, which optimizes the operation steps and reduces the incidence of complications; the outer diameter is small in the undeployed state, and it can be delivered to the target occluding area such as the aorta and peripheral artery through a smaller puncture needle or catheter sheath, which reduces the trauma to the blood vessel and shortens the recovery time; there is a guiding device at the distal end of the metal skeleton, which can not only provide guidance and support during catheter delivery, but also ensure the coaxiality of the device and the target blood vessel during the unfolding process, and ensure the fit of the occluding film with the inner cavity of the target blood vessel.

[0035] The device of the utility model has a simple structure, low material requirements, and easy process implementation. Therefore, compared with the prior art, a smaller catheter outer diameter can be achieved, less damage to the punctured blood vessel, fewer puncture-related complications, and faster patient recovery.

[0036] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, preferred embodiments are given below and described in detail with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] In order to more clearly illustrate the specific implementation methods of the utility model or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the utility model. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0038] Figure 1 (a) is a schematic diagram of the artery occlusion device of the present invention in a contracted state;

[0039] Figure 1 (b) is a schematic diagram of the artery occlusion device of the present invention in a partially deployed state;

[0040] Figure 1 (c) is a schematic diagram of the artery occlusion device of the present invention in a fully deployed state;

[0041] Figure 2 (a) is a schematic diagram of the woven mesh structure of the metal skeleton of the utility model;

[0042] Figure 2 (b) is a schematic diagram of the lantern frame structure of the metal frame of the utility model;

[0043] Figure 2 (c) is a schematic diagram of the spiral structure of the metal skeleton of the utility model;

[0044] Figure 3 (a) is a schematic diagram of the linear structure of the guide device of the present invention.

[0045] Figure 3 (b) is a schematic diagram of the “J”-shaped structure of the guiding device of the present invention.

[0046] Figure 3 (c) is a schematic diagram of the "P" type structure of the guiding device of the utility model.

[0047] Figure 3 (d) is a schematic diagram of the spiral structure of the guiding device of the present invention.

[0048] Figure 4 (a) is a cross-sectional view of the traction structure assembly of an embodiment of the utility model.

[0049] Figure 4 (b) is a cross-sectional view of the traction structure assembly of another embodiment of the utility model.

[0050] Figure 4 (c) is a cross-sectional view of the traction structure assembly of the third embodiment of the utility model.

[0051] FIG. 5 ( a ) is a schematic diagram of the handle structure and assembly of an embodiment of the utility model.

[0052] FIG5( b ) is a schematic diagram of the handle structure and assembly of another embodiment of the present invention. DETAILED DESCRIPTION

[0053] The following will be combined with the drawings in the embodiments of the utility model to clearly and completely describe the technical solutions in the embodiments of the utility model. Obviously, the described embodiments are only a part of the embodiments of the utility model, rather than all the embodiments. The components of the embodiments of the utility model generally described and shown in the drawings here can be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of the utility model provided in the drawings is not intended to limit the scope of the utility model claimed for protection, but merely represents the selected embodiments of the utility model. Based on the embodiments of the utility model, all other embodiments obtained by those skilled in the art without making creative work belong to the scope of protection of the utility model.

[0054] The present invention is further described in detail below so that those skilled in the art can implement the invention with reference to the description.

[0055] First, please refer to Figure 1 , Figure 1 This is a schematic diagram of an artery occlusion device according to an embodiment of the utility model; Figure 1 (a) is a schematic diagram of the artery occlusion device in the contracted state. Figure 1 (b) is a schematic diagram of the artery occlusion device in a partially deployed state. Figure 1 (c) is a schematic diagram of the fully deployed artery occlusion device. Figure 1 As shown, the center of the artery occluding device 1 in this embodiment is a composite structure composed of a metal skeleton 11 and an outer occluding film 12; the distal ends of the metal skeleton 11 and the occluding film 12 are connected to the guide device 2, and the proximal ends are connected to the hollow catheter 3; the proximal end of the hollow catheter 3 is connected to the operating handle 4, and is connected to the operating handle fixed part 41; the distal end of the traction structure 13 is fixed to the distal ends of the metal skeleton 11 and the occluding film 12, and its proximal end extends through the inner cavity of the hollow catheter 3 to the operating handle 4, and is connected to the operating handle movable part 42. According to this structure, the operator can push the traction structure 13 to the distal end or pull it to the proximal end by manipulating the operating handle movable part 42, thereby driving the distal ends of the metal skeleton 11 and the occluding film 12 to move, thereby realizing the expansion or contraction of the artery occluding device.

[0056] Then please refer to Figure 2 , Figure 2 The figure is a schematic diagram of a metal skeleton structure of an embodiment of the utility model. Figure 2 (a) Schematic diagram of the metal frame woven mesh structure; Figure 2 (b) is a schematic diagram of the lantern frame structure with a metal frame; Figure 2 (c) is a schematic diagram of the helical structure of the metal skeleton; Figure 2 As shown, the metal skeleton 11 can have a variety of structures. In this embodiment, the structure of the metal skeleton 11 includes but is not limited to a woven mesh, a lantern skeleton, a basket shape, a spiral shape, or any structure that can achieve its target purpose. The material is preferably nickel-titanium alloy, which can be processed into a target skeleton structure by weaving, laser cutting, laser welding, etc.

[0057] In some embodiments, the length of the metal skeleton 11 is 10-40 mm, preferably 30-40 mm, and is mainly used to block blood vessels with an inner diameter of less than 35 mm. The length of the metal skeleton 11 is not limited by this embodiment and can be adjusted according to the expected blocking area and the vascular anatomical structure of the area.

[0058] Then please refer to Figure 3 , Figure 3(a) is a schematic diagram of the linear structure of the guide device of the utility model, Figure 3 (b) is a schematic diagram of the "J"-shaped structure of the guide device of the utility model, Figure 3 (c) is a schematic diagram of the "P" type structure of the guiding device of the utility model, Figure 3 (d) is a schematic diagram of the spiral structure of the guide device of the utility model. In some embodiments, the guide device 2 is 2-15 cm long, preferably 10-15 cm when used in the aorta, and preferably 5-10 cm when used in the peripheral artery, so as to safely guide the arterial occlusion device 1 to the designated position. In particular, the head of the guide device 2 can be designed in different shapes, including but not limited to a straight line with a smooth head end, a "J" type, a "P" type or a spiral shape. Because the size, spatial structure, presence or absence of vascular bifurcation or opening of the target blood vessel will be different, in order to achieve satisfactory support performance, in some embodiments, different heads need to be designed according to different usage scenarios. Similarly, because the path from the vascular puncture site to the target blood vessel will have different sizes, spatial structures, vascular bifurcation conditions and running, in order to achieve satisfactory passing performance, different heads also need to be designed according to different usage scenarios. In addition, by optimizing the head shape, hardness, smoothness, material selection, surface treatment, etc., the damage of the occlusion device to the blood vessel can also be reduced.

[0059] Preferably, in some embodiments, the structure and material design of the guide device 2 are the same as those of a medical guide wire to achieve a better guiding effect. In some embodiments, the guide device 2 can be made of metal material, polymer material or metal and polymer composite material according to the vascular anatomical structure and mechanical properties of the target occlusion area, and connected to the distal end of the metal skeleton 11 by welding, bonding, etc.

[0060] Then please refer to Figure 4 , Figure 4 (a) is a cross-sectional view of the traction structure assembly of an embodiment of the utility model; Figure 4 (b) is a cross-sectional view of the traction structure assembly of another embodiment of the utility model; Figure 4 (c) is a cross-sectional view of the traction structure assembly of the third embodiment of the utility model. Depending on whether the guide device 2 is hollow or not, the traction structure 13 can be stopped at the far end of the metal frame 11, such as Figure 4 As shown in (a), it can also extend into the interior of the guide device 2 and stop at the head end of the guide device 2, such as Figure 4 In particular, in some embodiments with special requirements, the guide device 2 can also be used as a traction structure 13, running through the entire artery occlusion device 1, such as Figure 4 (c). Figure 4In the case shown in (c), the guide device 2 can be a solid structure or a hollow tube, which is used to establish a passage between a blood vessel and the outside world to facilitate the release of contrast agents or drugs as needed.

[0061] Then please refer to Figure 5, which is a schematic diagram of the handle structure and assembly of the utility model. Figure 5 (a) is a schematic diagram of the handle structure and assembly of an embodiment of the utility model; Figure 5 (b) is a schematic diagram of the handle structure and assembly of another embodiment of the utility model. In this embodiment, the operating handle 4 can be made of metal or plastic. Preferably, in some embodiments, the fixed part 41 of the operating handle and the movable part 42 of the operating handle are threadedly matched to achieve fine control of the diameter of the blocking part, as shown in Figure 5 (a). In some embodiments, the traction structure 13 can stop at the proximal end of the movable part 42 of the operating handle, and in other embodiments it can also be completely penetrated. The traction structure 13 and the movable part 42 of the operating handle can be fixed in a suitable position by screwing, welding, bonding, etc.

[0062] In particular, in other embodiments, the cooperation between the fixed part 41 of the operating handle and the movable part 42 of the operating handle can adopt a stepped buckle design, as shown in FIG5 (b). As shown in FIG5 (a), the bayonet 44 is arranged on the movable part 42 of the operating handle, and the card slot 43 is arranged on the fixed part 41 of the operating handle. The card slot 43 can be a hollow design to facilitate indicating the position of the operating handle 4 when it is locked; or the card slot 43 can be designed only inside the fixed part 41 of the operating handle for aesthetic reasons. This patent does not limit the specific form of the buckle design. This embodiment is only for example. Any staged locking design can be used for the assembly of the fixed part 41 of the operating handle and the movable part 42 of the operating handle.

[0063] In particular, in the embodiment suitable for abdominal aorta occlusion, since the delivery distance is short and the blood vessels are less tortuous, a thin-walled metal tube can be selected as the hollow catheter 3. Therefore, the entire artery occlusion device 1 except the operating handle 4 can be controlled within an outer diameter of 4Fr, or even reach a thickness of 3Fr, and can enter the blood vessel through a 3-4Fr vascular sheath. Under some conditions, thanks to the guide device 2 similar to a guide wire at the front end of the device, the artery occlusion device 1 can be directly delivered into the artery through a puncture needle for occlusion. Compared with the balloon occlusion devices currently on the market that generally require 7-12Fr vascular sheaths, the wound caused by the device is smaller, which is beneficial to the patient's recovery.

[0064] The material of the hollow catheter 3 includes but is not limited to metal, polymer material or metal and polymer composite material. The appropriate catheter material, structure and length can be selected according to the location of the target occlusion area, the difficulty of delivery and the thickness of the blood vessels along the route.

[0065] The blocking film 12 includes, but is not limited to, polymer materials such as collagen, nylon, TPE (thermoplastic rubber), TPU (thermoplastic polyurethanes), or any material and structure that can limit or block blood flow. It can be processed by electrospinning, extrusion, etc., and its two ends are fixed to the two ends of the metal skeleton 11 by bonding, heat sealing, suturing, etc.

[0066] Although the embodiments of the present invention have been disclosed above, they are not limited to the applications listed in the specification and the embodiments. It can be fully applied to various fields suitable for the present invention. For those familiar with the art, additional modifications can be easily realized. Therefore, without departing from the general concept defined by the claims and the scope of equivalents, the present invention is not limited to the specific details and the illustrations shown and described here.

Claims

1. An artery occlusion device, characterized in that From the proximal end to the distal end, it includes an operating handle, a hollow catheter, a metal skeleton, a blocking film, a traction structure and a guide device; wherein: the operating handle is used to control the expansion or contraction of the metal skeleton; the hollow catheter, whose distal end is connected to the metal skeleton and the blocking device, and whose proximal end is connected to the operating handle; the metal skeleton, which can freely adjust the size of the blocking device by expansion and contraction; the blocking film, which covers the outside of the metal skeleton and is used to achieve the blocking function; the traction structure, whose proximal end is connected to the operating handle; the guide device, which is located at the distal end of the blocking device, and whose proximal end is fixed to the distal end of the metal skeleton.

2. An artery occlusion device according to claim 1, characterized in that The operating handle includes a movable part and a fixed part; the traction structure is pushed toward the distal end or pulled toward the proximal end by operating the movable part of the operating handle, thereby driving the distal end of the metal skeleton and the film to move, thereby realizing the expansion or contraction of the occluding device.

3. An artery occlusion device as claimed in claim 2, characterized in that The proximal end of the hollow catheter is connected to the fixed part of the operating handle.

4. An artery occlusion device as claimed in claim 2, characterized in that The proximal end of the traction structure extends through the inner cavity of the hollow catheter to the operating handle and is connected to the movable part of the operating handle.

5. An artery occlusion device as claimed in claim 2, characterized in that The fixed part and the movable part of the operating handle are matched with each other by threads to realize the fine control of the diameter of the blocking part.

6. An artery occlusion device as claimed in claim 2, characterized in that The cooperation between the fixed part and the movable part of the operating handle can adopt a stepped buckle design.

7. An artery occlusion device as claimed in claim 2, characterized in that The traction structure may stop at the proximal end of the movable portion of the operating handle, or may completely penetrate the movable portion.

8. An artery occlusion device as claimed in claim 1, characterized in that The guiding device provides guidance and support during the catheter delivery process, ensures the coaxiality of the device and the target blood vessel during the deployment process, and ensures that the blocking film fits the inner cavity of the target blood vessel.

9. An artery occlusion device as claimed in claim 1, characterized in that The metal frame structure is a woven mesh structure, a lantern frame structure, a flower basket structure or a spiral structure.

10. The artery occlusion device according to claim 1, characterized in that The metal skeleton is made of nickel-titanium alloy.

11. The artery occlusion device according to claim 1, characterized in that The length of the metal skeleton is 10-40 mm.

12. An artery occlusion device according to claim 1, characterized in that The length of the metal skeleton is 30-40 mm.

13. An artery occlusion device according to claim 1, characterized in that The blocking film is made of polymer material.

14. The artery occlusion device according to claim 1, characterized in that The length of the guiding device is 2-15 cm.

15. The artery occlusion device according to claim 1, characterized in that The length of the guide device is selected to be 10-15 cm when used in the aorta.

16. The artery occlusion device according to claim 1, characterized in that The length of the guide device is selected to be 5-10 cm when used in a peripheral artery.

17. The artery occlusion device according to claim 1, characterized in that The head of the guide device is designed to be a straight line with a smooth head end, a "J" shape, a "P" shape or a spiral shape.

18. The artery occlusion device according to claim 1, characterized in that The structure and material design of the guiding device are the same as those of the medical guide wire, so as to play a better guiding role.

19. The artery occlusion device according to claim 1, characterized in that The traction structure may stop at the distal end of the metal frame, or may extend into the interior of the guiding device and stop at the head end of the guiding device.

20. The artery occlusion device according to claim 1, characterized in that The hollow conduit is made of metal, polymer material or a metal and polymer composite material.

21. The artery occlusion device according to claim 1, characterized in that The hollow conduit may be a thin-walled metal tube.

22. The artery occlusion device according to claim 1, characterized in that The artery occlusion device, except for the operating handle, can be controlled to have an outer diameter of 3Fr, and can enter the blood vessel through a vascular sheath of 3-4Fr.

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