Artery plugging device

Abstract

The invention provides an artery occlusion device. The artery occlusion device comprises a control handle, a hollow catheter, a metal framework, an occlusion film, a traction structure and a guide device, the control handle freely adjusts the unfolding size of the plugging device by controlling unfolding or folding of the metal framework and the plugging film, the plugging device adapts 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 present invention relates to the field of artery packaging, in particular to an artery occlusion device. Background Art

[0002] The main existing arterial occlusion technique is resuscitative balloon occlusion of the aorta (REBOA), which can be used to treat non-compressive traumatic truncal bleeding. Recent reports indicate that this technology and related medical devices can also be used to treat traumatic hemorrhage, non-traumatic abdominal bleeding, postpartum hemorrhage, placenta accreta spectrum (PAS), and cardiopulmonary resuscitation (CPR), demonstrating significant clinical significance and increasingly broad applicability.

[0003] Existing arterial occlusion devices mainly use balloon catheters, that is, an inflatable balloon is set at the distal end of the catheter, the balloon is delivered to the target location of the artery through the catheter, and then fluid is injected into the balloon through the catheter to inflate the balloon and tightly fit the arterial wall, thereby achieving the purpose of occlusion.

[0004] However, existing balloon catheters have the following disadvantages:

[0005] Compliant balloons are prone to exceeding safe dimensions as pressure increases during clinical use, leading to balloon rupture or damage to the arterial wall.

[0006] Non-compliant and semi-compliant balloons require pre-designed inflation sizes to accommodate different vascular specifications, which increases production costs and surgical preparation time. Inappropriate size selection can also reduce occlusion effectiveness and safety.

[0007] 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.

[0008] In terms of convenience, the balloon must be injected with sufficient liquid when used. In trauma scenarios, the product cannot be 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.

[0009] In addition, 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 mesh to achieve the purpose of blocking blood flow from the vascular wound out of the blood vessel.

[0010] However, these vascular closure devices lack distal fixation and cannot maintain coaxiality with the target vessel. Consequently, the occlusion device may deflect and fail to completely block blood flow across the cross section, resulting in incomplete vascular occlusion.

[0011] 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 diameter of the target blood vessel to be occluded. Similarly, its filling size must be pre-designed to accommodate different blood vessel specifications, which increases production costs and surgical preparation time. If the size is not selected appropriately, the occlusion effect and safety will also be reduced.

[0012] Therefore, existing technologies, whether balloon-based or non-balloon-based, cannot meet the clinical demand for arterial occlusion devices. A safer, more effective and convenient arterial occlusion device is needed.

[0013] Therefore, in order to solve the shortcomings of the existing technology 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 needs of low production cost, low complication rate and easy use. Summary of the Invention

[0014] The purpose of the present invention is to address the shortcomings of the prior art, such as high production costs, long surgical preparation time, reduced occlusion effect and poor safety. It provides a diameter-controllable artery rapid occlusion device that can freely adjust the expanded size of the occlusion device according to different blood vessel diameters and occlusion requirements. It is simple to operate, has good occlusion effect and high safety.

[0015] To achieve this purpose, the present invention provides an arterial occlusion device, which comprises, from the proximal end to the distal end, a control handle, a hollow catheter, a metal frame, an occlusion film, a traction structure, and a guide device; wherein:

[0016] A control handle is used to control the expansion or contraction of the metal frame;

[0017] A hollow catheter, the distal end of which is connected to the metal skeleton and the occlusion device, and the proximal end of which is connected to the control handle;

[0018] The metal skeleton can adjust the size of the occlusion device by expanding and contracting;

[0019] The sealing film is covered on the outside of the metal frame to achieve the sealing function;

[0020] A traction structure, a proximal end of which is connected to the control handle;

[0021] 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.

[0022] The operating handle includes a movable part and a fixed part; by manipulating the movable part of the operating handle to push the traction structure toward the distal end or pull it toward the proximal end, the distal end of the metal skeleton and the film are displaced, thereby realizing the expansion or contraction of the occlusion device.

[0023] 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.

[0024] 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.

[0025] The pulling structure may terminate at the proximal end of the movable portion of the operating handle or may extend completely through it.

[0026] 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.

[0027] The metal frame structure is a woven mesh structure, a lantern frame structure, a basket-like structure, or a spiral structure. The metal frame is made of nickel-titanium alloy. The length of the metal frame is 10-40 mm, preferably 30-40 mm.

[0028] The sealing film is made of polymer material.

[0029] 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.

[0030] The guide head is designed to be a straight, J-shaped, P-shaped, or spiral-shaped with a smooth tip. The structure and material design of the guide are the same as those of medical guidewires, providing a better guiding effect.

[0031] The traction structure may end at the distal end of the metal frame, or may extend into the interior of the guide device and end at the head end of the guide device.

[0032] The hollow catheter is made of metal, polymer material or a metal and polymer composite material.

[0033] The artery occlusion device according to claim 1 is characterized in that the hollow catheter can be a thin-walled metal tube.

[0034] 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.

[0035] The beneficial effects of the present invention are that the device of the present invention can freely adjust the expansion size of the occlusion device according to different blood vessel diameters and occlusion requirements, adapt to target blood vessels of different diameters, simplify or eliminate the step of selecting appropriate instruments before surgery, and improve the occlusion effect and adaptability; it adopts a structure of metal skeleton and occlusion film, and there is no need to pump air or inject liquid. The connection strength, air tightness and water tightness requirements between the various components of the product are lower than those of balloons, which optimizes the production process and reduces production costs; there is no need to pump air or inject liquid, it is not easy to rupture or damage blood vessels, the operation steps are optimized, and the incidence of complications is reduced; in the undeployed state, the outer diameter is small, and it can be delivered to the target occlusion area such as the aorta and peripheral artery through a smaller puncture needle or catheter sheath, reducing trauma to the blood vessels and shortening recovery time; there is a guide 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 deployment process, ensuring the fit of the occlusion film to the inner cavity of the target blood vessel.

[0036] The device of the present invention has a simple structure, low material requirements, and is easy to manufacture. Therefore, compared to existing technologies, it can achieve a smaller catheter outer diameter, less damage to the punctured blood vessel, fewer puncture-related complications, and faster patient recovery.

[0037] 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

[0038] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the specific embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

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

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

[0041] Figure 1 (c) is a schematic diagram of the artery occlusion device of the present invention in a fully deployed state;

[0042] Figure 2 (a) is a schematic diagram of the woven mesh structure of the metal skeleton of the present invention;

[0043] Figure 2(b) is a schematic diagram of the lantern frame structure of the metal frame of the present invention;

[0044] Figure 2 (c) is a schematic diagram of the helical structure of the metal skeleton of the present invention;

[0045] Figure 3 (a) is a schematic diagram of the linear structure of the guiding device of the present invention.

[0046] Figure 3 (b) is a schematic diagram of the "J"-shaped structure of the guiding device of the present invention.

[0047] Figure 3 (c) is a schematic diagram of the "P" type structure of the guiding device of the present invention.

[0048] Figure 3 (d) is a schematic diagram of the spiral structure of the guiding device of the present invention.

[0049] Figure 4 (a) is a cross-sectional view of the traction structure assembly according to an embodiment of the present invention.

[0050] Figure 4 (b) is a cross-sectional view of the traction structure assembly according to another embodiment of the present invention.

[0051] Figure 4 (c) is a cross-sectional view of the traction structure assembly according to the third embodiment of the present invention.

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

[0053] FIG5( b ) is a schematic diagram of the handle structure and assembly of another embodiment of the present invention. DETAILED DESCRIPTION

[0054] The technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, not all of the embodiments. The components of the embodiments of the present invention generally described and shown in the drawings herein can be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of the present invention provided in the drawings is not intended to limit the scope of the claimed invention, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without making creative work are within the scope of protection of the present invention.

[0055] The present invention is described in further detail below so that those skilled in the art can implement the invention with reference to the description.

[0056] First, please refer to Figure 1, Figure 1 This is a schematic diagram of an artery occlusion device according to an embodiment of the present invention; 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 arterial occlusion device in a fully deployed state. Figure 1 As shown, the core of the artery occlusion device 1 in this embodiment is a composite structure consisting of a metal skeleton 11 and an outer occlusion film 12. The distal ends of the metal skeleton 11 and occlusion film 12 are connected to the guide device 2, and their 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 to the fixed portion 41 of the operating handle. The distal end of the traction structure 13 is fixed to the distal ends of the metal skeleton 11 and occlusion film 12, and its proximal end extends through the lumen of the hollow catheter 3 to the operating handle 4 and is connected to the movable portion 42 of the operating handle. Based on this structure, the operator can push or pull the traction structure 13 distally or proximally by manipulating the movable portion 42 of the operating handle, thereby causing the distal ends of the metal skeleton 11 and occlusion film 12 to move, thereby expanding or contracting the artery occlusion device.

[0057] Then please refer to Figure 2 , Figure 2 Schematic diagram of the metal skeleton structure of an embodiment of the present invention. Figure 2 (a) is a schematic diagram of the metal frame 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-shaped structure, a spiral structure, or any other structure that can achieve its intended purpose. It is preferably made of nickel-titanium alloy and can be processed into the desired skeleton structure through weaving, laser cutting, laser welding, etc.

[0058] 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 desired blocking area and the vascular anatomical structure of the area.

[0059] Then please refer to Figure 3 , Figure 3 (a) is a schematic diagram of the linear structure of the guide device of the present invention, Figure 3 (b) is a schematic diagram of the "J"-shaped structure of the guiding device of the present invention, Figure 3 (c) is a schematic diagram of the "P" type structure of the guiding device of the present invention, Figure 3(d) is a schematic diagram of the spiral structure of the guide device of the present invention. In some embodiments, the guide device 2 is 2-15 cm in length, preferably 10-15 cm when used in the aorta and 5-10 cm when used in peripheral arteries, to safely guide the arterial occlusion device 1 to the designated location. Specifically, the head of the guide device 2 can be designed in various shapes, including but not limited to a linear, "J"-shaped, "P"-shaped, or spiral-shaped head with a smooth tip. Because the target vessel varies in size, spatial structure, presence of bifurcations, or openings, in some embodiments, different head designs are required for different usage scenarios to achieve satisfactory support performance. Similarly, because the path from the vascular puncture site to the target vessel varies in size, spatial structure, bifurcations, and trajectory, different head designs are required for different usage scenarios to achieve satisfactory passage performance. Furthermore, by optimizing the head shape, hardness, smoothness, material selection, surface treatment, etc., damage to the vessel caused by the occlusion device can be reduced.

[0060] Preferably, in certain embodiments, the structure and material design of the guide device 2 are the same as those of a medical guidewire to provide a better guiding effect. In some embodiments, the guide device 2 can be made of a metal material, a polymer material, or a metal and polymer composite material based on the vascular anatomy and mechanical properties of the target occlusion area, and connected to the distal end of the metal framework 11 by welding, bonding, or other methods.

[0061] Then please refer to Figure 4 , Figure 4 (a) is a cross-sectional view of a traction structure assembly according to an embodiment of the present invention; Figure 4 (b) is a cross-sectional view of a traction structure assembly according to another embodiment of the present invention; Figure 4 (c) is a cross-sectional view of the traction structure assembly of the third embodiment of the present invention. 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, as shown in 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) is shown. Figure 4 In 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 the blood vessel and the outside world to facilitate the release of contrast agent or drug according to demand.

[0062] Then please refer to Figure 5, which is a schematic diagram of the handle structure and assembly of the present invention. Figure 5(a) is a schematic diagram of the handle structure and assembly of an embodiment of the present invention; Figure 5(b) is a schematic diagram of the handle structure and assembly of another embodiment of the present invention. 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 threaded together to achieve fine control of the diameter of the blocking part, as shown in Figure 5(a). In some embodiments, the traction structure 13 may stop at the proximal end of the movable part 42 of the operating handle, and in other embodiments, it may 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.

[0063] In particular, in other embodiments, the fit between the fixed portion 41 of the operating handle and the movable portion 42 of the operating handle may adopt a stepped buckle design, as shown in FIG5(b). As shown in FIG5(a), the bayonet 44 is provided on the movable portion 42 of the operating handle, and the card slot 43 is provided on the fixed portion 41 of the operating handle. The card slot 43 may be a hollow design to facilitate indicating the position of the operating handle 4 when it is locked; or the card slot 43 may be designed only inside the fixed portion 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 illustration, and any staged locking design may be used for the assembly of the fixed portion 41 of the operating handle and the movable portion 42 of the operating handle.

[0064] 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 arterial occlusion device 1 except for the operating handle 4 can be controlled within an outer diameter of 4Fr, or even up to 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 arterial occlusion device 1 can be directly delivered into the artery through a puncture needle for occlusion. Compared with the balloon occlusion device currently on the market that generally requires a 7-12Fr vascular sheath, the wound caused by the device is smaller, which is beneficial to the patient's recovery.

[0065] The hollow catheter 3 may be made of, but not limited to, metal, polymer, or a metal and polymer composite material. Suitable catheter material, structure, and length may be selected based on the location of the target occlusion area, the difficulty of delivery, and the thickness of the vessel being delivered.

[0066] 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 capable of restricting or blocking blood flow. It can be formed by electrospinning, extrusion, or other methods, and its ends are secured to the ends of the metal frame 11 by bonding, heat sealing, or suturing.

[0067] Although the embodiments of the present invention have been disclosed above, they are not limited to the applications listed in the specification and exemplary embodiments. They can be applied to a variety of fields suitable for the present invention. Further modifications will be readily apparent to those skilled in the art. Therefore, the present invention is not limited to the specific details and illustrations shown and described herein without departing from the general concept defined by the claims and their equivalents.

Claims

1. An artery occlusion device, characterized in that From the proximal end to the distal end, it includes a control handle, a hollow catheter, a metal skeleton, a blocking film, a traction structure and a guide device; wherein: the control handle is used to control the expansion or contraction of the metal skeleton; the hollow catheter, the distal end of which is connected to the metal skeleton and the blocking device, and the proximal end of which is connected to the control handle; the metal skeleton realizes free adjustment of the size of the blocking device by expansion and contraction; the blocking film covers the outside of the metal skeleton and is used to realize the blocking function; the traction structure, the proximal end of which is connected to the control handle; the guide device is located at the distal end of the blocking device, and the proximal end of which 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; by manipulating the movable part of the operating handle to push the traction structure toward the distal end or pull it toward the proximal end, the distal end of the metal skeleton and the film are displaced, thereby realizing the expansion or contraction of the occluding device.

3. An artery occlusion device according to 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 according to 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. The artery occlusion device according to claim 2, characterized in that The fixed part and the movable part of the operating handle are matched with each other through threads to achieve fine control of the diameter of the blocking part.

6. The artery occlusion device according to 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. The artery occlusion device according to claim 2, characterized in that The pulling structure may stop at the proximal end of the movable portion of the operating handle, or may completely penetrate the movable portion.

8. The artery occlusion device according to claim 1, characterized in that The guiding device provides guidance and support during the delivery of the catheter, and can also ensure the coaxiality of the device and the target blood vessel during the deployment process, ensuring that the occluding film fits the inner cavity of the target blood vessel.

9. The artery occlusion device according to claim 1, characterized in that The metal skeleton structure is a woven mesh structure, a lantern skeleton 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. The artery occlusion device according to claim 1, characterized in that The length of the metal skeleton is preferably 30-40 mm.

13. The 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 a medical guide wire, so as to achieve a better guiding effect.

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

Images