Arterial thrombus protection device and embolism system

Abstract

The utility model relates to the technical field of medical instruments, and provides an arterial thrombus protection device and an embolism system. The filtering piece comprises a shape memory skeleton and a woven net film which is arranged on the shape memory skeleton and is used for intercepting thrombus; the two ends of the shape memory framework are closed up through the first annular piece and the second annular piece correspondingly. The first annular piece fixedly sleeves the guide wire, and the second annular piece slidably sleeves the guide wire; one end of the traction wire is connected with the second annular piece, and the other end is in vitro. According to the arterial thrombus protection device, the filtering piece can be adjusted in a self-adaptive mode according to the size of a blood vessel, the filtering piece can be better attached to the blood vessel, and therefore the effect of capturing fallen plaques or thrombus is improved, and the risk of an operation is reduced; and moreover, the position movement of the filtering piece caused by the length change of the guide wire placed in the body can be avoided, and the operation effect and safety are ensured.

Description

TECHNICAL FIELD

[0001] The utility model relates to medical instrument technical field, concretely relates to a kind of arterial thrombus protection device and embolization system. BACKGROUND

[0002] In the field of medical devices, especially in the field of vascular surgery, arterial thrombus protection devices are an important tool for preventing plaque or thrombus and other substances from falling off from the blood vessel wall during surgery, thereby reducing the risk of distal vessel occlusion. These devices are usually designed to be temporarily placed in the blood vessel and removed after the surgery is completed. In the field of biomedical engineering, metal woven filter structure is a commonly used material, which is widely used in medical devices due to its good biocompatibility and mechanical strength. In addition, guide wires play an important role in the field of medical devices, commonly used for guiding and placing various medical devices.

[0003] Existing carotid artery protection devices are usually composed of an expandable filter, which can be delivered to the target position by a guide wire. When the filter reaches the predetermined position, it can be expanded to capture the plaque or thrombus that may fall off. After the surgery is completed, the filter can be retracted and removed by the guide wire. However, the existing arterial thrombus protection device cannot adaptively adjust the size of the filter according to the size of the blood vessel after being released in the body. If the size of the released filter is too large, the burden on the blood vessel will be too heavy, and even the blood vessel may be damaged. If the size of the released filter is too small, it may not capture the falling plaque or thrombus completely, thereby increasing the risk to the patient. SUMMARY

[0004] Therefore, the utility model wants to solve the technical problem that the existing arterial thrombus protection device cannot adaptively adjust the size of the filter according to the size of the blood vessel after being released in the body, thereby providing an arterial thrombus protection device and embolization system.

[0005] To solve the above technical problems, the technical solution of the utility model is as follows:

[0006] The utility model provides an arterial thrombus protection device, comprising: a guide wire; a filter, the filter comprising a shape memory skeleton and a woven mesh film for intercepting thrombus arranged on the shape memory skeleton; the two ends of the shape memory skeleton are respectively closed by a first ring-shaped part and a second ring-shaped part; the first ring-shaped part is fixedly sleeved on the guide wire, and the second ring-shaped part is slidably sleeved on the guide wire; a traction wire, one end connected to the second ring-shaped part and the other end located outside the body, drives the second ring-shaped part to move along the guide wire by retracting and releasing the traction wire, to adjust the radial diameter of the filter.

[0007] Further, the shape memory framework comprises a plurality of support rods, proximal ends of the plurality of support rods are arranged on the second ring-shaped member, distal ends of the plurality of support rods are arranged on the first ring-shaped member, the plurality of support rods enclose a ring structure, and a radial dimension of the ring structure is adjustable.

[0008] Further, the support rod comprises a first end and a second end, along a direction from the first end to the second end, the radial dimension of the ring structure first increases and then decreases.

[0009] Further, the woven mesh is a metal woven mesh with elasticity.

[0010] Further, a proximal end of the guide wire is provided with a winding and unwinding mechanism, one end of the traction wire away from the second ring-shaped member is wound on the winding and unwinding mechanism, and the winding and unwinding mechanism controls the radial diameter of the filter by adjusting the number of winding turns of the traction wire.

[0011] Further, a handle is sleeved on the proximal end of the guide wire, the winding and unwinding mechanism is arranged on the handle, and the winding and unwinding mechanism is a rotary winding and unwinding mechanism.

[0012] Further, the first limiting member and the second limiting member are arranged on the guide wire in a spaced manner and are fixed relative to the guide wire, and the position of the filter on the guide wire is between the first limiting member and the second limiting member.

[0013] Further, a distal end of the guide wire is provided with an elastic member.

[0014] Further, the balloon is sleeved on the guide wire, the guide wire has a hollow lumen, the lumen extends to the proximal end of the guide wire and forms a lumen inlet, the lumen extends to the distal end of the guide wire and forms a side hole in the side wall of the guide wire, and the side hole communicates with the balloon.

[0015] In another aspect, the utility model provides a kind of embolism system, including conveying catheter and above-mentioned the arterial thrombus protection device, the conveying catheter is sleeved outside the arterial thrombus protection device, when injecting filling medium into the balloon by the guide wire, side hole, the balloon expands and is attached with the inner wall of the conveying catheter, to limit the movement of the guide wire relative to the conveying catheter.

[0016] In another aspect, the utility model provides a kind of embolism system, including delivery catheter and the arterial thrombus protection device described in any of above, the filter piece has compressed state and release state, in the compressed state, the filter piece is housed in the inside of the delivery catheter, and the filter piece has first length value;In the release state, the filter piece is separated from the delivery catheter, the filter piece has second length value, and the first length value is greater than the second length value.

[0017] The utility model technical scheme has the following advantages:

[0018] The arterial thrombus protection device provided by the utility model, when the filter piece reaches the target position, in addition to relying on the characteristics of the shape memory skeleton to release itself, the second ring-shaped piece can also be driven to move along the guide wire by retracting and releasing the traction wire to adjust the release degree of the filter piece, the filter piece is self-adaptively adjusted according to the size of the blood vessel, can better fit the blood vessel, thereby improving the effect of capturing the detached plaque or thrombus and reducing the risk of surgery;Moreover, the release of the filter piece is completed by the traction wire, so that the length of the guide wire placed in the body remains stable during the operation process, thereby avoiding the movement of the filter piece position caused by the change of the length of the guide wire placed in the body, and ensuring the effect and safety of the operation. BRIEF DESCRIPTION OF DRAWINGS

[0019] In order to more clearly illustrate the specific embodiment of the utility model or the technical scheme in the prior art, the following will briefly introduce the drawings needed to be used in the specific embodiment or the prior art description, and obviously, the drawings in the following description are some embodiments of the utility model, and those skilled in the art can also obtain other drawings according to these drawings without creating labor.

[0020] Figure 1 It is a schematic view of the arterial thrombus protection device (after the filter piece is released) in the embodiment of the utility model;

[0021] Figure 2 It is a schematic view of the arterial thrombus protection device (before the filter piece is released) in the embodiment of the utility model;

[0022] Figure 3 It is a schematic view of the filter piece in the arterial thrombus protection device in the embodiment of the utility model;

[0023] Figure 4 It is a front view of the shape memory skeleton in the arterial thrombus protection device in the embodiment of the utility model;

[0024] Figure 5 It is a side view of the shape memory skeleton (after release) in the arterial thrombus protection device in the embodiment of the utility model;

[0025] Figure 6 Figure 2 is a side view of the shape memory framework (before release) of the arterial thrombus protection device in the embodiment of the present application;

[0026] Figure 7 Figure 3 is a schematic view of the balloon (after expansion) of the arterial thrombus protection device in the embodiment of the present application;

[0027] Figure 8 Figure 4 is a schematic view of the arterial thrombus protection device in the embodiment of the present application in a use state.

[0028] Explanation of reference signs:

[0029] 1, filter; 2, guide wire; 3, traction wire; 4, shape memory framework; 5, woven mesh membrane; 6, first annular member; 7, second annular member; 8, first limiting member; 9, second limiting member; 10, delivery catheter; 11, balloon; 12, elastic member; 13, retracting and releasing mechanism; 14, side hole; 15, handle; 16, inner cavity; 17, inner cavity inlet. DETAILED DESCRIPTION

[0030] The technical solutions of the present application will be described clearly and completely below with reference to the drawings. Obviously, the described embodiments are only some of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0031] In the description of the present application, it should be noted that the orientations or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are based on the orientations or positional relationships shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application. In addition, the terms "first", "second", "third" are only for the purpose of description, and cannot be understood as indicating or implying relative importance.

[0032] In the description of the present application, it should be noted that unless otherwise explicitly specified and limited, the terms "mounting", "connection", "connecting" should be understood broadly, for example, it can be fixed connection, or detachable connection, or integrally connected; it can be mechanical connection, or electrical connection; it can be directly connected, or indirectly connected through an intermediate medium, or the communication inside two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0033] In order to more clearly describe the structure of the present application, the terms "proximal end" and "distal end" are defined herein as terms commonly used in the field of interventional medicine. Specifically, "distal end" refers to the end far from the operator during the operation, "proximal end" refers to the end close to the operator during the operation, "axial direction" refers to the length direction, and "radial direction" refers to the direction perpendicular to the "axial direction".

[0034] In addition, the technical features involved in the different embodiments of the utility model described below can be combined with each other as long as there is no conflict between them.

[0035] As shown in Figure 1 , Figure 2 , Figure 3 The present embodiment provides an arterial thrombus protection device, comprising a guide wire 2, a filter 1, the filter 1 comprising a shape memory skeleton 4 and a woven omentum 5 for intercepting thrombus arranged on the shape memory skeleton 4, both ends of the shape memory skeleton 4 being closed by a first ring-shaped part 6 and a second ring-shaped part 7 respectively, the first ring-shaped part 6 being fixedly sleeved on the guide wire 2, the second ring-shaped part 7 being slidably sleeved on the guide wire 2, a traction wire 3 being connected to the second ring-shaped part 7 at one end and being located outside the body at the other end, the second ring-shaped part 7 being driven to move along the guide wire 2 by retracting and releasing the traction wire 3 to adjust the radial diameter of the filter 1. For example, the first ring-shaped part 6 and the second ring-shaped part 7 can be metal rings.

[0036] The arterial thrombus protection device provided by the present embodiment releases the filter 1 by means of the traction wire 3 when the filter 1 reaches the target position, and at the same time, the shape memory skeleton 4 of the filter 1 is made of shape memory material and can adaptively adjust its size according to the size of the blood vessel within a certain range, thereby improving the effect of capturing the detached plaque or thrombus and reducing the risk of the operation. Moreover, the release of the filter 1 is completed by the relaxation of the traction wire 3, so that the length of the guide wire 2 placed in the body remains stable during the operation, thereby avoiding the movement of the filter 1 due to the change of the length of the guide wire 2 placed in the body and ensuring the effect of the operation.

[0037] In the present embodiment, the shape memory skeleton 4 is a self-expanding stent, so the shape memory skeleton 4 has a compressed state and an expanded state. In the compressed state, the traction wire 3 pulls the filter 1 to move towards the proximal end, the shape memory skeleton 4 can be accommodated in the delivery catheter 10, the shape memory skeleton 4 can be accommodated in the blood vessel, and at this time, the release of the filter 1 is completed by the relaxation of the traction wire 3, the filter 1 can adaptively adjust its size according to the size of the blood vessel within a certain range, further increasing the adhesion of the filter 1 to the blood vessel, thereby avoiding the leakage of the captured thrombus due to the poor adhesion of the filter 1 to the blood vessel during the operation.

[0038] As shown in Figure 3、 Figure 4 、 Figure 5 and Figure 6 As shown in the drawings, the shape memory framework 4 comprises a plurality of support rods, the proximal ends of the plurality of support rods are arranged on the second ring member 7, the distal ends of the plurality of support rods are arranged on the first ring member 6, the plurality of support rods enclose a ring structure, and the radial size of the ring structure is adjustable. The support rod comprises a first end and a second end, and along the direction from the first end to the second end, the radial size of the ring structure first increases and then decreases. For example, the support rod can be made of a memory alloy.

[0039] In the released state, the contact between the support rod and the blood vessel wall forms a circular arc, which improves the adhesion of the shape memory framework 4 to the blood vessel wall.

[0040] The woven mesh 5 is a metal woven mesh 5 with a certain elasticity. In this way, the umbrella-shaped shape memory framework 4 provides stable support, and the metal woven mesh with a certain elasticity ensures the flexibility and capture effect of the filter 1. Moreover, the expansion and retraction process of the filter 1 can be made simpler and more convenient, thereby reducing the difficulty and risk of the operation, shortening the operation time, and improving the operation efficiency.

[0041] In order to display the position state of the two ends of the shape memory framework 4 during the operation, the first ring member 6 and the second ring member 7 can be respectively provided with a first developing element. For example, the two first developing elements are respectively embedded in the interiors of the first ring member 6 and the second ring member 7.

[0042] In order to determine the opening state or the radial diameter of the shape memory framework 4, a second developing element is arranged in the middle of the support rod, and the second developing element is arranged on the support rod and located at or close to the maximum radial diameter of the support rod. By arranging the second developing element, the opening state of the shape memory framework 4 can be effectively determined, thereby helping to improve the precision of the operation. In addition, the second developing element can cooperate with the first developing element, so that when the filter 1 is released and compressed, the opening state of the shape memory framework 4 and the positions of the proximal end and the distal end of the shape memory framework 4 can be judged under the DSA subtraction equipment.

[0043] The proximal end of the guide wire 2 is sleeved with a handle 15, the handle 15 is provided with the releasing mechanism 13, and the end of the traction wire 3 away from the second ring member 7 is wound on the releasing mechanism 13. The releasing mechanism 13 controls the radial diameter of the filter 1 by adjusting the winding number of the traction wire 3. The releasing mechanism 13 can be a rotary releasing mechanism, for example, the releasing mechanism 13 is a winch type switch.

[0044] The arterial thrombus protection device further comprises a first limiting member 8 and a second limiting member 9. The first limiting member 8 and the second limiting member 9 are arranged on the guide wire 2 in a spaced manner and are fixed relative to the guide wire 2. The position of the filter member 1 on the guide wire 2 is between the first limiting member 8 and the second limiting member 9. For example, the first limiting member 8 and the second limiting member 9 can be limiting blocks which are distributed along the circumference of the guide wire 2 and protrude outward relative to the guide wire 2. The first limiting member 8 and the second limiting member 9 limit the possibility of large sliding of the filter member 1, so as to prevent the filter member 1 from failing to capture the thrombus due to large movement of the position of the filter member 1.

[0045] The arterial thrombus protection device further comprises a delivery catheter 10. The filter member 1 has a compressed state and a released state. In the compressed state, the filter member 1 is accommodated in the inside of the delivery catheter 10, and the filter member 1 has a first length value. In the released state, the filter member 1 is separated from the delivery catheter 10, and the filter member 1 has a second length value. The first length value is greater than the second length value. In use, the filter member 1 and the guide wire 2 are accommodated in the delivery catheter 10, and it is confirmed that the filter member 1 can be smoothly expanded and retracted. Then, the delivery catheter 10 can be placed in the body through a sheath tube. When the front end of the delivery catheter 10 reaches the target position, the filter member 1 is released from the delivery catheter 10.

[0046] As shown in FIG. 1, Figure 7 The arterial thrombus protection device further comprises a balloon 11 which is sleeved on the guide wire 2. The guide wire 2 has a hollow lumen 16 which extends to the proximal end of the guide wire 2 and forms a lumen inlet 17. The lumen 16 extends to the distal end of the guide wire 2 and forms a side hole 14 on the side wall of the guide wire 2. The side hole 14 communicates with the balloon 11. After filling medium (for example, physiological saline) is injected into the balloon 11 through the guide wire 2 and the side hole 14, the balloon 11 is inflated and adheres to the inner wall of the delivery catheter 10, so as to limit the movement of the guide wire 2 relative to the delivery catheter 10. In use, an external filling medium injector is connected to the proximal end of the guide wire 2, and the filling medium is injected into the balloon 11 through the lumen of the guide wire 2. In this way, the relative position of the guide wire 2 and the delivery catheter 10 can be fixed by using the anchoring effect of the balloon 11, so that the product has high stability during the operation.

[0047] The distal end of the guide wire 2 is provided with an elastic member 12. The elastic member 12 increases the outer diameter of the distal end of the guide wire while maintaining the bending strength of the guide wire, and increases the supporting force in pushing the guide wire and the flexibility of the guide wire in a curved position. Meanwhile, the elastic member 12 increases the torque transmission, and when the guide wire is rotated in the operation, the distal end of the guide wire can be twisted synchronously, avoiding the phenomenon that the distal end head swings. The elastic member 12 can be a developing spring. The developing spring can also display the position of the distal end of the guide wire under X-ray. The developing material of the developing spring can be tungsten gold wire, platinum wire, etc.

[0048] Figure 8 The figure is a schematic view of the arterial thrombus protection device in the embodiment of the utility model in the use state. The arrow in the figure indicates the blood flow direction. In use, step 1: the arterial thrombus protection device is prepared, the filter element 1 and the guide wire 2 are first collected in the delivery catheter 10, and it is confirmed that the filter element 1 can be smoothly unfolded and withdrawn.

[0049] Step 2: after the delivery catheter 10 is placed in the specified blood vessel position through a sheath tube or the like, the guide wire 2 is pushed out of the delivery catheter 10 to a certain position, and the filter element 1 is released at the specified position through the folding and unfolding mechanism 13 to make it fully unfold.

[0050] Step 3: after the filter element 1 is unfolded, physiological saline is injected into the balloon 11, the balloon 11 is inflated to fix the guide wire 2 on the delivery catheter 10, and the shaking and displacement of the guide wire 2 are reduced. Since the filter element 1 is located on the guide wire 2, and the two ends are respectively the first limiting member 8 and the second limiting member 9, at this time, the position of the filter element 1 relative to the delivery catheter 10 is also fixed within a certain range.

[0051] Step 4: after the operation is completed, the physiological saline in the balloon 11 is extracted, the guide wire 2 is first withdrawn a part, then the filter element 1 is collected through the folding and unfolding mechanism 13, if there is basically no resistance, the filter element 1 can be completely withdrawn into the delivery catheter 10, and then the filter element 1, the guide wire 2 and the delivery catheter 10 are withdrawn from the human body together. When there are many emboli, the filter element 1 can not be completely recovered, at this time, when the folding and unfolding mechanism 13 feels abnormal resistance, the winding is stopped, at this time, the filter element 1 has a part of the closing phenomenon, and the delivery catheter 10, the guide wire 2 and the filter element 1 are withdrawn together.

[0052] In summary, the arterial thrombus protection device in the application has the advantages of simplified operation steps, stable length of the guide wire 2, improved capturing effect, higher safety in the use process, and is suitable for more patient groups.

[0053] Obviously, the above embodiments are only examples for clearly illustrating the present application and are not intended to limit the present application. Based on the above description, other different forms of changes or variations can be made by those skilled in the art. Here, all the embodiments are not required to be enumerated. The changes or variations derived therefrom are still within the protection scope of the present application.

Claims

1. An arterial thrombosis protection device, characterized in that, include: Guide wire (2); The filter element (1) includes a shape memory skeleton (4) and a braided mesh (5) disposed on the shape memory skeleton (4) for intercepting thrombi; the two ends of the shape memory skeleton (4) are respectively closed by a first annular member (6) and a second annular member (7); the first annular member (6) is fixedly sleeved on the guidewire (2), and the second annular member (7) is slidably sleeved on the guidewire (2); The traction wire (3) is connected at one end to the second annular member (7) and at the other end outside the body. By retracting and extending the traction wire (3), the second annular member (7) is driven to move along the guide wire (2) to adjust the radial diameter of the filter element (1).

2. The arterial thrombosis protection device according to claim 1, characterized in that, The shape memory skeleton (4) includes several support rods, with the proximal ends of the support rods disposed on the second annular member (7) and the distal ends of the support rods disposed on the first annular member (6). The support rods are arranged to form an annular structure, and the radial dimension of the annular structure is adjustable.

3. The arterial thrombosis protection device according to claim 2, characterized in that, The support rod includes a first end and a second end, and the radial dimension of the annular structure first increases and then decreases along the direction from the first end toward the second end.

4. The arterial thrombosis protection device according to claim 1, characterized in that, The woven mesh (5) is a metal woven mesh (5) with a certain elasticity.

5. The arterial thrombosis protection device according to claim 1, characterized in that, The guide wire (2) is provided with a take-up and release mechanism (13) at its proximal end. The end of the traction wire (3) away from the second annular member (7) is wound around the take-up and release mechanism (13). The take-up and release mechanism (13) controls the radial diameter of the filter element (1) by adjusting the number of turns of the traction wire (3).

6. The arterial thrombosis protection device according to claim 5, characterized in that, A handle (15) is sleeved on the proximal end of the guide wire (2), and the take-up and release mechanism (13) is provided on the handle (15). The take-up and release mechanism (13) is a rotary take-up and release mechanism.

7. The arterial thrombosis protection device according to claim 1, characterized in that, It also includes a first limiting member (8) and a second limiting member (9); The first limiting member (8) and the second limiting member (9) are spaced apart on the guide wire (2) and are both fixed relative to the guide wire (2); The filter element (1) is positioned on the guide wire (2) between the first limiting element (8) and the second limiting element (9).

8. The arterial thrombosis protection device according to claim 1, characterized in that, The distal end of the guide wire (2) is provided with an elastic element (12).

9. The arterial thrombosis protection device according to claim 1, characterized in that, It also includes a balloon (11) fitted onto the guidewire (2); The guidewire (2) has a hollow inner cavity (16) that extends to the proximal end of the guidewire (2) and forms an inner cavity inlet (17). The inner cavity (16) extends to the distal end of the guidewire (2) and forms a side hole (14) on the side wall of the guidewire (2). The side hole (14) communicates with the balloon (11).

10. An embolization system, characterized in that, Includes a delivery catheter (10) and an arterial thrombosis protection device according to claim 9. The delivery catheter (10) is sleeved outside the arterial thrombosis protection device. When a filling medium is injected into the balloon (11) through the guidewire (2) and the side hole (14), the balloon (11) expands and fits against the inner wall of the delivery catheter (10) to restrict the movement of the guidewire (2) relative to the delivery catheter (10).

11. An embolization system, characterized in that, The device includes a delivery conduit (10) and an arterial thrombosis protection device according to any one of claims 1-9, wherein the filter element (1) has a compressed state and a released state, wherein in the compressed state, the filter element (1) is housed inside the delivery conduit (10) and the filter element (1) has a first length value; and in the released state, the filter element (1) is detached from the delivery conduit (10) and the filter element (1) has a second length value, wherein the first length value is greater than the second length value.

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