Embolic protection device and embolic protection system

Abstract

The application discloses an embolism protection device and an embolism protection system. The embolism protection device comprises a delivery guide wire, a support framework, an elastic bag and a filter. The delivery guide wire has a cavity structure. The support framework has a cavity structure, and a proximal end of the support framework is connected to the delivery guide wire. The support framework is arranged to be telescopic so that a distal end of the support framework has an expansion state and a contraction state. The elastic bag is arranged at the distal end of the support framework, and the elastic bag is communicated with the cavity structure of the support framework. Filling medium entering through the cavity structure of the delivery guide wire makes the elastic bag expand and fill so as to drive the distal end of the support framework to expand. The filter is connected to the elastic bag and changes in shape with the change of the elastic bag. After the elastic bag and the filter expand, the elastic bag and the filter are attached to the inner wall of a blood vessel. Since the elastic bag has a certain elasticity, the elastic bag can not cause damage to the blood vessel under the condition that the elastic bag is well attached to the inner wall of the blood vessel.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of manufacturing embolic protection devices, and in particular to an embolic protection device and an embolic protection system. BACKGROUND

[0002] When treating arterial stenosis by means of arterial stent implantation, a large number of embolic fragments are generated. These tiny embolic fragments, which enter the brain, lungs, heart and other organs along with the blood flow, can cause serious diseases. In order to reduce such risks of complications, an embolic protection device is placed at the distal end of the stent implantation site to capture the tiny embolic fragments generated during the operation, while not affecting the normal flow of liquid in the blood vessel. After the arterial stent is successfully implanted, the embolic protection device is removed from the body along with the intercepted embolic fragments through a recovery catheter.

[0003] In the related art, in order to achieve better recovery of embolic fragments, it is necessary to ensure that the embolic protection device is tightly fitted with the blood vessel after being released, and then due to the non-uniformity of the diameter of the blood vessel, the fitting of the two is often not tight enough. SUMMARY

[0004] To solve the above technical problems, the present application provides an embolic protection device and an embolic protection system which can be tightly fitted with the inner wall of the blood vessel.

[0005] The first aspect of the present application provides an embolic protection device, comprising: a delivery guide wire having a cavity structure; a support skeleton having a cavity structure, the proximal end of the support skeleton being connected to the delivery guide wire, the support skeleton having an expanded state and a contracted state; an elastic bag arranged at the distal end of the support skeleton, the elastic bag being in communication with the cavity structure of the support skeleton, and the inflation medium entering through the cavity structure of the delivery guide wire causing the elastic bag to inflate and expand, thereby driving the distal end of the support skeleton to expand; and a filter connected to the elastic bag and changing in shape with the change of the elastic bag.

[0006] In the present application, the delivery guide wire and the support skeleton both have cavity structures, and the inflation medium delivered through the delivery guide wire can expand the elastic bag and further drive the support skeleton and the filter to expand. After the elastic bag and the filter expand, they are fitted with the inner wall of the blood vessel. Since the elastic bag has a certain elasticity, it can cause no damage to the blood vessel while being well fitted with the inner wall of the blood vessel. The filter can change in shape with the change of the elastic bag, and can be suitable for different blood vessels.

[0007] In the embodiment of the present application, the distal end of the support skeleton is provided with a recessed portion recessed inward in the radial direction of the delivery guide wire, the elastic bag is contained in the recessed portion, and the elastic bag in the inflated state is not lower than the surface of the support skeleton.

[0008] The recess is inwardly recessed in the radial direction of the delivery guide wire, such a recess can limit the displacement of the elastic capsule during the expansion process, so that the elastic capsule does not displace during the expansion process. When the elastic capsule reaches a certain transverse area (transverse area in the axial direction), such a recess can also make the elastic capsule expand more in the radial direction, so that the elastic capsule can fill the gap between the inner wall of the blood vessel and the supporting framework, ensure the adhesion of the embolic protection device, and the soft elastic capsule in contact with the blood vessel wall can reduce the risk of blood vessel spasm.

[0009] In the embodiment of the present application, the supporting framework comprises a fixed part with a cavity structure, a first supporting part, and a plurality of supporting rods connected between the fixed part and the first supporting part, the fixed part is connected to the delivery guide wire, the first supporting part is connected to the elastic capsule, the proximal end of the supporting rod is connected to the fixed part, and the distal end of the supporting rod is a movable end, wherein the supporting framework is in an umbrella-shaped expanded state when the distal ends of the plurality of supporting rods move away from each other in the radial direction.

[0010] In the embodiment of the present application, the elastic capsule is arranged inside the filter, the filter is opened and the opening is directed to the delivery guide wire when the elastic capsule is in a full state, and the filter comprises a plurality of filter holes.

[0011] In the embodiment of the present application, in the axial direction of the delivery guide wire, the hole diameter of the plurality of filter holes gradually decreases from the proximal end to the distal end of the supporting framework.

[0012] Such a filter hole diameter distribution can present a progressive filter for capturing emboli, and can better and more perfectly capture emboli. Specifically, the hole diameter of the filter at the proximal opening is larger and the hole diameter at the distal end is smaller, so the emboli captured at the opening will move to the distal end of the filter under the scouring of the blood flow, and since the hole diameter at the distal end is smaller, the emboli will not escape from the filter, so whether in the capturing process or in the recovery process, the captured emboli will not flow out of the filter.

[0013] In the embodiment of the present application, the surface of the filter has a drug coating, and the drug coating at least comprises an anti-vascular spasm drug coating.

[0014] The anti-vascular spasm drug coating can avoid vascular spasm.

[0015] In the embodiment of the present application, the supporting framework comprises a second supporting part extending in the axial direction of the delivery guide wire, and one end of the filter opposite to the opening is connected to the second supporting part.

[0016] In the embodiments of the present application, the embolic protection device comprises a first developing ring, which is arranged at the proximal end of the support framework to fix the support framework and the delivery guide wire; and / or the embolic protection device comprises a second developing ring, which is sleeved on the second support part, and the filter is connected to the second developing ring.

[0017] The first developing ring not only can fix the support framework and the delivery guide wire, but also has a developing function for positioning the embolic protection device in the blood vessel.

[0018] The second developing ring not only can fix the support framework and the filter, but also has a developing function for positioning the embolic protection device in the blood vessel.

[0019] In the embodiments of the present application, the embolic protection device comprises an elastic member, which is arranged at the end of the distal end of the second support part.

[0020] The elastic member is located at the front end of the entire support framework, which can play a role of shock absorption and buffering, and avoid damage to the blood vessel caused by the device during delivery / recovery.

[0021] In the embodiments of the present application, a filling control module is arranged, which is used to control the expansion range of the support framework by controlling the delivery amount of the filling medium.

[0022] By arranging the filling control module, the amount of filling medium can be adjusted according to the diameter of different blood vessels, so as to be suitable for different diameters of blood vessels.

[0023] The second aspect of the present application provides an embolic protection system, which comprises the embolic protection device of the first aspect.

[0024] In the embodiments of the present application, the embolic protection system comprises a delivery catheter, the embolic protection device is accommodated in the delivery catheter to be released after being delivered to the target position, the filling medium is delivered through the delivery guide wire to make the support framework and the filter expand; and / or the embolic protection system comprises a recovery catheter, which moves along the direction from the proximal end to the distal end of the support framework to compress the support framework and the elastic bag, so as to recover the embolic protection device to the recovery catheter.

[0025] In the embodiments of the present application, when the embolic protection device is recovered to the recovery catheter, the filter is accommodated in the recovery catheter or located outside the recovery catheter.

[0026] When the embolic protection device is recovered, the filter can be located outside the recovery catheter, which can be suitable for the case of more emboli, and avoid the outflow of the captured emboli caused by the filter entering the recovery catheter.

[0027] In the present application, the delivery guide wire and the support skeleton both have a cavity structure, and the elastic bag can be expanded by delivering the filling medium through the delivery guide wire, thereby driving the support skeleton and the filter to expand. After the elastic bag and the filter are expanded, they are attached to the inner wall of the blood vessel. Since the elastic bag has a certain elasticity, it can be attached to the inner wall of the blood vessel without causing damage to the blood vessel. The filter can change shape along with the change of the elastic bag, and can be suitable for different blood vessels. BRIEF DESCRIPTION OF DRAWINGS

[0028] Various other advantages and benefits will become apparent to those of ordinary skill in the art upon reading the following detailed description of the preferred embodiments. The detailed description is made with reference to the accompanying drawings.

[0029] Figure 1 A schematic diagram of the embolic protection device provided by some embodiments of the present application in a state of being located at a first position in a blood vessel;

[0030] Figure 2 A schematic diagram of the embolic protection device provided by some embodiments of the present application in a state of being located at a first position in a blood vessel;

[0031] Figure 3 A schematic diagram of the structure of the embolic protection device provided by some embodiments of the present application;

[0032] Figure 4 A schematic diagram of the side view structure of the support skeleton provided by some embodiments of the present application;

[0033] Figure 5 A schematic diagram of the cross-sectional structure of the support skeleton provided by some embodiments of the present application;

[0034] Figure 6 A schematic diagram of the cross-sectional structure of the support skeleton provided by some embodiments of the present application;

[0035] Figure 7 A schematic diagram of the structure of the embolic protection system provided by some embodiments of the present application in a state of releasing the embolic protection device in a blood vessel;

[0036] Figure 8 A schematic diagram of the cross-sectional structure of the embolic protection device provided by some embodiments of the present application in a state of being located in a blood vessel;

[0037] Figure 9 A schematic diagram of the structure of the embolic protection system provided by some embodiments of the present application in a state of releasing the embolic protection device in a blood vessel;

[0038] BRIEF DESCRIPTION OF DRAWINGS

[0039] 1 embolic protection device; 2 blood vessel; 3 embolic protection system; 10 delivery guide wire; 101 filling inlet; 20 support framework; 21 fixed part; 22 first support part; 23 support rod; 24 recessed part; 25 second support part; 30 elastic bag; 31 balloon tube foot; 40 filter; 41 filter hole; 51 first developing ring; 52 second developing ring; 303 third developing ring; 60 elastic member; 71 delivery catheter; 72 recovery catheter; 80 embolus fragment; 90 stenosis lesion; 91 dilated lesion. DETAILED DESCRIPTION

[0040] The embodiments of the technical scheme of the present application will be described in detail below with reference to the drawings. The following embodiments are only used to more clearly illustrate the technical scheme of the present application, and therefore only serve as examples, but cannot limit the protection scope of the present application.

[0041] When an arterial stent is implanted to treat arterial stenosis, a large number of embolus fragments are generated. These tiny embolus fragments enter the brain, lungs, heart, etc. along with the blood flow, which can cause serious diseases. In order to reduce such complications, an embolic protection device is placed at the distal end of the stent implantation point to capture the tiny embolus generated during the operation, while not affecting the normal flow of liquid in the blood vessel. After the arterial stent is successfully implanted, the embolic protection device is removed out of the body together with the intercepted embolus through the recovery catheter.

[0042] In the related art, in order to achieve better recovery of embolus, it is necessary to ensure that the embolic protection device is tightly fitted with the blood vessel after being released, and then due to the non-uniformity of the diameter of the blood vessel, the fitting of the two is often not tight enough.

[0043] For example, carotid artery stenosis is one of the main causes of ischemic stroke, and its incidence is increasing year by year. When a carotid artery stent is implanted to treat carotid artery stenosis, a large number of embolus fragments are generated. These tiny embolus fragments enter the brain along with the blood flow, which can cause cerebral stroke or damage brain nerve function. In order to reduce such complications, an embolic protection device is placed at the distal end of the stent implantation point to capture the tiny embolus generated during the operation, while not affecting the normal flow of liquid in the blood vessel. After the carotid artery stent is successfully implanted, the embolic protection device is removed out of the body together with the intercepted embolus through the recovery catheter.

[0044] To solve the above technical problems, the present application provides an embolic protection device capable of being tightly fitted with the inner wall of a blood vessel. Based on the same or similar concept, the present application can also provide an embolic protection system.

[0045] The embolism protection device provided in the application comprises a delivery guide wire having a cavity structure; a support framework having a cavity structure, the proximal end of the support framework being connected to the delivery guide wire, the support framework being arranged to be retractable so that the distal end of the support framework has an expanded state and a contracted state; an elastic bag arranged at the distal end of the support framework, the elastic bag being in communication with the cavity structure of the support framework, the elastic bag having a filling state and a pressure relief state which change with the distal end of the support framework; and a filter connected to the elastic bag and changing in shape with the elastic bag, wherein the filling medium entering through the cavity structure of the delivery guide wire causes the elastic bag to expand, thereby driving the distal end of the support framework to expand.

[0046] In the application, the delivery guide wire and the support framework both have cavity structures, and the filling medium delivered through the delivery guide wire can expand the elastic bag and drive the support framework and the filter to expand. After the elastic bag and the filter expand, they are attached to the inner wall of the blood vessel, and since the elastic bag has a certain elasticity, it can be attached to the inner wall of the blood vessel without causing damage to the blood vessel. The filter can change in shape with the change of the elastic bag, and can be suitable for different blood vessels.

[0047] Figure 1 A state diagram of the embolism protection device provided in some embodiments of the application when located at a first position in a blood vessel; Figure 2 A state diagram of the embolism protection device provided in some embodiments of the application when located at a first position in a blood vessel; Figure 3 A structural diagram of the embolism protection device provided in some embodiments of the application; Figure 4 A side view structural diagram of the support framework provided in some embodiments of the application; Figure 5 A cross-sectional structural diagram of the support framework provided in some embodiments of the application; Figure 6 A cross-sectional structural diagram of the contact part between the elastic bag and the first support part provided in some embodiments of the application; Figure 7 A structural diagram of the embolism protection system provided in some embodiments of the application for releasing the embolism protection device in a blood vessel; Figure 8 A cross-sectional structural diagram of the embolism protection device provided in some embodiments of the application when located in a blood vessel; Figure 9 A structural diagram of the embolism protection system provided in some embodiments of the application for releasing the embolism protection device in a blood vessel.

[0048] As shown in Figures 1 to 6 The embolism protection device 1 provided in the application can comprise a delivery guide wire 10, a support framework 20, an elastic bag 30 and a filter 40. The delivery guide wire 10 can extend in the axial direction of the delivery guide wire 10, the delivery guide wire 10 has a hollow cavity structure which can extend in the axial direction of the delivery guide wire 10, and the delivery guide wire 10 delivers filling medium to the support framework 20 through the cavity structure.

[0049] In the present application, the delivery guide wire 10 can have a proximal end and a distal end, the end relatively close to the operator during operation is called the proximal end, and the end relatively far from the operator is called the distal end. The proximal end of the delivery guide wire 10 has a filling inlet 101, and a filling medium can enter through the filling inlet 101. The distal end of the delivery guide wire 10 can be connected with the support skeleton 20.

[0050] In the present application, the material of the delivery guide wire 10 can be stainless steel or shape memory alloy, etc. The diameter of the delivery guide wire 10 can be 0.2mm-0.4mm, and the diameter of the delivery guide wire 10 can be 0.25mm, 0.3mm, 0.35mm. The delivery guide wire 10 is provided with an elastic capsule 30 pressure relief cavity, which is connected with the cavity of the support skeleton 20, and the proximal end of the delivery guide wire 10 is connected with the filling inlet 101 for controlling the expansion and contraction of the elastic capsule 30. The surface of the delivery guide wire 10 can be coated with a high polymer lubricating coating to reduce the resistance during the pushing process of the delivery guide wire 10. Specifically, the high polymer lubricating coating can use the coating in the prior art, which is not limited in the present application, and can be designed and selected by the person skilled in the art according to the actual situation. Coating the surface of the delivery guide wire 10 with a high polymer lubricating coating reduces the pushing difficulty, so that the operator can more easily and accurately push the guide wire to the target position, improving the convenience and accuracy of the operation. At the same time, reducing the resistance helps to reduce the friction and damage to the inner wall of the blood vessel, reducing the risk of complications of the blood vessel. In addition, the smooth pushing process can shorten the operation time, reduce the pain and risk of patients during the operation, and also improve the efficiency and safety of the operation.

[0051] In the present application, the support skeleton 20 can have a hollow cavity structure, and the filling medium entering through the hollow cavity structure of the delivery guide wire 10 can enter the cavity structure of the support skeleton 20 to expand the distal end of the support skeleton 20.

[0052] In the present application, the support skeleton 20 can form the pressure relief cavity of the elastic capsule 30 together with the hollow cavity of the delivery guide wire 10. The support skeleton 20 can be composed of shape memory metal such as nickel-titanium alloy through hot forming process. After the delivery catheter is withdrawn at the appropriate position, the expansion of the elastic capsule 30 drives the expansion of the support skeleton 20, providing good support and adhesion for the filter 40.

[0053] In the embodiment of the present application, the support skeleton 20 can include a fixed part 21, a first support part 22, and a plurality of support rods 23 connected between the fixed part 21 and the first support part 22. The fixed part 21 is connected to the distal end of the delivery guide wire 10, the first support part 22 can be connected with the elastic capsule 30, the proximal end of the support rod 23 is connected to the fixed part 21, and the distal end of the support rod 23 is a movable end.

[0054] In the embodiments of the present application, the fixed part 21, the support rod 23 and the first support part 22 can all be provided with cavity structures, and the cavity structures in the fixed part 21, the support rod 23 and the first support part 22 can be sequentially communicated to allow the filling medium to pass through.

[0055] When the distal ends of the plurality of support rods 23 are away from each other in the radial direction, the support framework 20 is in an expanded state, as shown in FIG. 1. Figures 1 to 3 As shown, the support framework 20 is in an expanded state. When the distal ends of the plurality of support rods 23 are close to each other in the radial direction, the support framework 20 is in a contracted state, as shown in FIG. 2. Figure 7 Figure 9 As shown, the support framework 20 is in a contracted state.

[0056] Each support rod 23 is provided with a pressure charging and discharging cavity (cavity structure) communicated with an elastic bag 30, and the hollow cavities (cavity structures) of the plurality of support rods 23 finally converge in the hollow cavity (cavity structure) of the delivery guide wire 10, together with the filling inlet 101, to form a control system of the elastic bag 30.

[0057] As shown in FIG. 1, the elastic bag 30 is located between the first support parts 22, and the recessed part 24 and the first support part 22 jointly limit the position of the elastic bag 30. The balloon tube foot 31 is connected with the hollow cavity of the support rod 23, so as to transmit the filling medium to control the pressure charging and discharging of the elastic bag 30. Figure 6 In the present application, as shown in FIG. 1, the support rod 23 can be provided as three, so that the structure formed is simple and relatively stable. However, the present disclosure is not limited thereto, and in some embodiments, the number of support rods 23 can be adaptively adjusted to other numbers.

[0058] Figures 1 to 3 In the present application, as shown in FIG. 1, when the support framework 20 is in a released state, the space in the radial direction of the fixed part 21, the transition part composed of the plurality of support rods 23 and the annular first support part 22 of the support framework 20 sequentially increases (similar to an umbrella shape), and when the radial space of the annular first support part 22 reaches the maximum, it is beneficial to the recovery of the embolism protection device 1 and takes into account the efficiency of embolus filtration.

[0059] In the embodiments of the present application, as shown in FIG. 1 and FIG. 2, the distal end of the support framework 20 is provided with a recessed part 24 recessed inward in the radial direction of the delivery guide wire, and the elastic bag 30 can be accommodated in the recessed part 24. Figure 3 In the embodiments of the present application, as shown in FIG. 1 and FIG. 2, when the support framework 20 is in a released state, the space in the radial direction of the fixed part 21, the transition part composed of the plurality of support rods 23 and the annular first support part 22 of the support framework 20 sequentially increases (similar to an umbrella shape), and when the radial space of the annular first support part 22 reaches the maximum, it is beneficial to the recovery of the embolism protection device 1 and takes into account the efficiency of embolus filtration.

[0060] Figure 2 Figure 3 In the embodiments of the present application, as shown in FIG. 1 and FIG. 2, the distal end of the support framework 20 is provided with a recessed part 24 recessed inward in the radial direction of the delivery guide wire, and the elastic bag 30 can be accommodated in the recessed part 24.

[0061] In the embodiments of the present application, as shown in FIG. 1 and FIG. 2, when the support framework 20 is in a released state, the space in the radial direction of the fixed part 21, the transition part composed of the plurality of support rods 23 and the annular first support part 22 of the support framework 20 sequentially increases (similar to an umbrella shape), and when the radial space of the annular first support part 22 reaches the maximum, it is beneficial to the recovery of the embolism protection device 1 and takes into account the efficiency of embolus filtration. Figure 2 Figure 3 ​​​​​As shown, the first support portion 22 can be annular to better fit the inner wall of the blood vessel 2. The first support portion 22 can be recessed inward in the radial direction of the guidewire delivery to form a recess 24, and the elastic capsule 30 can be accommodated in the recess 24.

[0062] like Figures 1 to 3 As shown, the elastic bladder 30 can be disposed at the distal end of the support frame 20. The cavity structure of the elastic bladder 30 is connected to the cavity structure of the support frame 20. The filling medium entering through the cavity structure of the guide wire causes the elastic bladder to inflate and expand, thereby driving the distal end of the support frame to expand.

[0063] In this embodiment, the elastic balloon 30 can be a ring-shaped balloon made of a compliant material such as polyurethane. The ring-shaped balloon can ensure the vascular apposition of the embolization protection device, avoiding the problem of gaps appearing in tortuous blood vessels and the escape of tiny emboli in traditional embolization protection devices.

[0064] like Figures 1 to 2 As shown, when the support frame 20 is in an expanded state, the filling medium can enter the elastic bladder 30 through the cavity structure of the support frame 20, and the elastic bladder 30 will then inflate. Figure 1 and Figure 2 As shown, by inflating the elastic bladder 30, the elastic bladder 30 can fit against the inner wall of the blood vessel 2, thereby achieving a tight fit between the embolization protection device and the inner wall of the blood vessel 2.

[0065] Figure 1 and Figure 2 The diagrams show the state of the embolization protection device in its first position within different blood vessels, through... Figure 1 and Figure 2 This explains that the elastic bladder 30 is positioned at different locations of vascular lesions, each with a different inner diameter. Due to its inflation and good conformability, the elastic bladder 30 adheres well to the inner wall of vessels with varying inner diameters, thus enabling the embolization protection device 1 to exhibit good wall adhesion at different vascular locations. It should be noted that the first position in this application refers to the placement position of the embolization protection device 1 within the blood vessel.

[0066] In this embodiment, the embolism protection device 1 may include a filling control device (not shown), which can be used to control the expansion range of the support frame by controlling the delivery amount of the filling medium. Figures 1 to 2 As shown, the inflation control device can control the inflation state of the elastic bladder 30 so that the surface of the elastic bladder 30 is exactly flush with the surface of the first support portion 22. This setting allows for better fit with the inner wall of the blood vessel 2, adapting to conditions such as... Figure 1 and Figure 2The different blood vessels are shown. For example, for the carotid artery, the extension of the blood vessels of the carotid artery is complex, and the inner diameter of the blood vessels changes more. The application can meet the various blood vessel conditions of the carotid artery. The filling control device can adopt a pressure filling pump or an injection device (for example, a syringe), and the delivery amount of the filling medium or the pressure of the elastic bag 30 can be identified through a scale or a pressure display.

[0067] It should be pointed out that the disclosure is not limited to the arrangement that the surface of the elastic bag 30 is flush with the surface of the first support part 22. In some embodiments, the surface of the elastic bag 30 can protrude from the surface of the first support part 22 to adapt to different blood vessel conditions.

[0068] In the embodiments of the application, the recessed part 24 is recessed inward in the radial direction of the delivery guide wire 10. Such a recessed part 24 can limit the displacement of the elastic bag 30 during the expansion of the elastic bag 30, so that the elastic bag 30 does not displace during the expansion. When the elastic bag 30 reaches a certain transverse area (transverse area in the axial direction), such a recessed part 24 can also make the elastic bag 30 expand more in the radial direction, so that the elastic bag 30 can fill the gap between the inner wall of the blood vessel 2 and the support skeleton 20, ensure the adhesion of the embolic protection device 1, and the soft elastic bag 30 in contact with the inner wall of the blood vessel 2 can reduce the risk of blood vessel spasm.

[0069] In the embodiments of the application, the elastic bag 30 can have a certain elasticity, for example, can be made of a compliant material such as polyurethane. The elastic bag 30 is fixed in the recessed part 24 of the support skeleton 20 by mechanical clamping and adhesive bonding. The elastic bag 30 can have a filling channel, and the filling channel inside the elastic bag 30 can be connected with the hollow cavity of each support rod 23. The expansion and contraction of the support skeleton 20 are controlled by the inflation and deflation of the elastic bag 30.

[0070] In the embodiments of the application, the filter 40 can be connected to the elastic bag 30 and can change shape with the change of the elastic bag 30. For example, in some embodiments, the elastic bag 30 can be arranged inside the filter 40, that is, the filter 40 is located outside the elastic bag 30. With the filling of the elastic bag 30, the filter 40 can be in contact with the inner wall of the blood vessel 2, which can maximize the capture of emboli.

[0071] In some embodiments, the open end of the filter 40 can be wrapped outside the distal end of the support skeleton 20. In some embodiments, the open end of the filter 40 can be wrapped outside the distal end of the support skeleton 20 and outside the elastic bag 30.

[0072] In the embodiments of the application, as shown in FIG. 1, the filter 40 can be arranged inside the elastic bag 30, that is, the elastic bag 30 is located outside the filter 40. Figures 1 to 3As shown, the filter 40 is open and the opening is directed to the delivery guide wire 10 when the elastic bag 30 is in the inflated state, and the filter 40 can include a plurality of filter holes 41.

[0073] In the embodiments of the present application, as shown in the drawings, Figures 1 to 3 As shown, in the axial direction of the delivery guide wire 10, the pore size of the plurality of filter holes 41 gradually decreases along the proximal end to the distal end of the support framework 20.

[0074] Such filter hole size distribution setting can present a progressive embolus capturing filter 40, which can better and more perfectly capture embolus. Specifically, the filter hole size at the proximal end of the opening is larger and the hole size at the distal end is smaller, so the embolus captured at the opening will move to the distal end of the filter due to the flushing of the blood flow, and due to the smaller hole size at the distal end, it will inevitably not escape from the distal end of the filter, so whether in the capturing process or in the recovery process, it will not cause the captured embolus to flow out of the filter 40.

[0075] It should be pointed out that the pore size of the filter holes on the filter of the present disclosure is not limited to the above-mentioned embodiments, and in some embodiments, the pore sizes of the plurality of filter holes are consistent.

[0076] During the operation process, the embolic protection device stimulates the carotid artery, which can easily cause carotid artery spasm. In the embodiments of the present application, the surface of the filter 40 has a drug coating, and the drug coating at least includes an anti-vasospasm drug coating. For example, the drug coating can include atropine, papaverine hydrochloride, heparin and other water-soluble anti-vasospasm drug coatings. This means that during the operation process, the anti-vasospasm drug can be provided to the blood vessel in a timely and targeted manner, effectively alleviating the problem of carotid artery spasm caused by device stimulation, further reducing the risk of operation and the probability of complications.

[0077] In the embodiments of the present application, the filter 40 can be an umbrella-shaped film integrally formed of a high polymer material, and the umbrella-shaped film can be uniformly perforated by laser process or the like, which can capture embolus while not affecting the circulation of intracavity liquid. The umbrella-shaped film can be made of TPU, PA and other high polymer materials. The umbrella-shaped film includes a filter screen opening end and a filter screen tail end. The pore size gradually decreases from the filter screen opening end to the filter screen tail end. In the embodiments of the present application, the pore size of the filter hole 41 can be in the range of 100-230 microns, for example, the pore size of the filter hole 41 can be 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220 microns.

[0078] In the embodiments of the present application, the support framework 20 can further include a second support portion 25 extending in the axial direction of the delivery guide wire 10, and the end of the filter 40 opposite to the opening is connected to the second support portion 25, that is, the distal end of the filter 40 is connected to the second support portion 25.

[0079] Through the arrangement of the second support part 25, not only the structural strength of the support framework 20 can be enhanced, but also the filter element 40 can be fixed.

[0080] In the embodiment of the present application, the embolic protection device 1 can include a first developing ring 51, which can be arranged at the proximal end of the support framework 20 to fix the support framework 20 and the delivery guide wire 10. As shown in the drawings, the first developing ring 51 can fix the fixed part 21 of the support framework 20 and the delivery guide wire 10. For example, the first developing ring 51 can fix the fixed part 21 of the support framework 20 and the delivery guide wire 10 by welding. The first developing ring 51 can be composed of a radiopaque metal wire spring. The first developing ring 51 can be composed of a metal material with good developing effect, such as gold or platinum. Figure 3

[0081] The first developing ring 51 not only can fix the support framework 20 and the delivery guide wire 10, but also has a developing function for positioning the embolic protection device 1 in the blood vessel.

[0082] In the embodiment of the present application, the embolic protection device 1 can include a second developing ring 52, which can be slidably arranged on the second support part 25, and the filter element 40 is connected to the second developing ring 52. The support framework 20 and the filter element 40 can be fixed by the second developing ring 52, which is beneficial to improve the structural stability of the embolic protection device 1. The second developing ring 52 can be composed of a radiopaque metal ring. The second developing ring 52 can be composed of a metal material with good developing effect, such as gold or platinum.

[0083] The second developing ring 52 not only can fix the support framework 20 and the filter element 40, but also has a developing function for positioning the embolic protection device in the blood vessel. When the delivery catheter or the recovery catheter compresses the support framework 20 and the filter element 40, the second developing ring 52 slides on the second support part 25, reduces the resistance of compressing the support framework 20 and the filter element 40, so that the support framework 20 can be smoothly received in the delivery catheter or the recovery catheter.

[0084] In the present application, as shown in the drawings, Figure 5 ​As shown, the embolic protection device 1 can include a third developing ring 303, and a circle of third developing rings 303 is also arranged at the first support part 22 of the umbrella-shaped support framework 20, so as to prompt the position of the first support part 22, and facilitate positioning the first support part 22 when the embolic protection device is recovered. When there are too many emboli, only the first support part 22 can enter the recovery catheter in the recovery process, so as to avoid the leakage of emboli. In the embodiment in which the support framework 20 is in an umbrella shape, it can be considered that the first support part 22 is at the position of the umbrella mouth, and at the same time, the first support part 22 is also at the opening position of the filter 40. When the captured emboli are too much, it is not convenient to recover the filter 40 to the recovery catheter, and then only the first support part 22 or part of the filter 40 can be recovered to the recovery catheter to avoid the leakage of emboli, and the leakage of emboli due to extrusion in the recovery process can also be avoided.

[0085] In the embodiment of the present application, as shown in Figure 1 The embolic protection device 1 can be provided with a first developing ring 51 and a second developing ring 52.

[0086] In the embodiment of the present application, the embolic protection device 1 includes an elastic member 60, which can be arranged at the distal end of the support framework 20. For example, the elastic member 60 can be arranged at the distal end of the second support part 25.

[0087] The elastic member 60 can be a spring tip printed by a flexible material 3D printed with a developing material. The developing material is a material that can be developed under X-ray irradiation. This makes the position of the distal end of the embolic protection device 1 easy to be observed, so as to facilitate determining whether the destination is reached. The elastic member 60 can be formed by connecting a spring and an elastic component such as silicone. The flexible material can be silicone, polyurethane or other soft materials, which not only can provide cushioning performance, but also has good biocompatibility, reduces the risk of postoperative complications, and helps the rapid recovery of patients.

[0088] At the same time, the integrated design reduces the connection gaps and potential breaking points between parts, improves the stability and reliability of the structure. In addition, the 3D printing technology can accurately control the shape, size and elastic performance of the spring, so that it better adapts to the bending and narrow parts of the blood vessel, and further enhances the protection effect. Optionally, the developing material includes at least one metal material of platinum, tungsten, bismuth and barium, or an alloy material of at least two metal materials, or a high polymer material added with at least one element. The above-mentioned materials all have good developing effect and good elasticity.

[0089] The elastic member 60 is located at the front end of the entire support framework 20, and in this embodiment, the elastic member 60 is located at the most distal end of the delivery guide wire 10. When encountering resistance, the elastic member 60 can avoid the resistance by bending and rebounding, thereby avoiding damage to the blood vessel during the delivery / recovery process of the device.

[0090] In the embodiments of the present application, as shown in Figure 7 and Figure 8 , the embolic protection system 3 can include the embolic protection device 1 and a delivery catheter 71. As shown in Figure 7 , the embolic protection device 1 can be accommodated in the delivery catheter 71 to be delivered to the target position. As shown in Figure 8 , when the embolic protection device 1 is delivered to the target position, the embolic protection device 1 is released, and after the release is complete, the inflation medium can be delivered through the delivery guide wire 10 to expand the support framework 20 and the elastic bag 30, and drive the filter 40 to expand.

[0091] Due to the arrangement of the elastic bag 30 and the filter 40, the delivery guide wire 10 can push the filter 40 to the carotid artery stenosis lesion position, and the delivery guide wire 10 does not affect the shape of the blood vessel.

[0092] As shown in Figure 9 , the embolic protection system 3 can include the embolic protection device 1 and a recovery catheter 72, and the recovery catheter 72 can move along the direction from the proximal end to the distal end of the support framework 20 to compress the support framework 20 and the elastic bag 30, so that the embolic protection device 1 is recovered to the recovery catheter 72.

[0093] In the embodiments of the present application, when the embolic protection device 1 is recovered to the recovery catheter 72, when the embolic debris 80 in the filter 40 is less, the filter 40 can be completely accommodated in the recovery catheter 72, and the embolic debris 80 cannot escape from the filter 40.

[0094] In some embodiments, when the embolic debris 80 in the filter 40 is more, when the embolic protection device 1 is recovered to the recovery catheter 72, the filter 40 can not be completely accommodated in the recovery catheter 72, that is, the filter 40 can be located outside the recovery catheter 72 when the embolic protection device 1 is recovered, but the gathering of the support rods 23 enables the embolic debris 80 to be completely clamped by the filter 40 and cannot escape from the filter 40.

[0095] As shown in Figure 8 and Figure 9 , after the stenosis lesion 90 in Figure 8 undergoes balloon angioplasty or stent implantation, the stenosis lesion 90 is reduced to form an expanded lesion 91, and the embolic debris 80 is completely intercepted by the filter 40, and then the filter 40 is accommodated in the recovery catheter 72, and the embolic debris 80 cannot escape from the filter 40.

[0096] In order to make the filter element can be smoothly delivered and recovered, the embolism protection device of the present application can be used in combination with the delivery / recovery catheter known in the art. The embolism protection device can be compressed loaded in the delivery catheter. When the embolism protection device reaches the lesion release position, a part of the delivery guide wire is withdrawn, and the support skeleton is preliminarily inflated to the relaxed state. By injecting normal saline through the inflation inlet of the delivery guide wire, the elastic bag is expanded and inflated, and due to the limiting effect of the recess, the elastic bag is more radially expanded, filling the gap between the blood vessel wall and the umbrella-shaped support skeleton, achieving good adhesion. When recovering, the inflation control device is connected to the inflation inlet 101 at the proximal end of the delivery guide wire 10, the inflation medium in the support skeleton 20 and the elastic bag 30 is extracted, so that the elastic bag 30 is contracted, at this time the elastic bag is almost in the recess, which greatly reduces the resistance of the elastic bag recovery. The recovery catheter extrudes the three support rods of the support skeleton, thereby driving the compression of the first support part, and the opening of the support skeleton can be determined by observing the third development ring, and the filter element can not be completely retracted into the recovery catheter, avoiding the leakage of embolus caused by excessive extrusion of the filter screen. Finally, the device is withdrawn out of the body.

[0097] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs; the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of this application; the use of the terms "including," "comprising," "having" and "with" in the specification and claims herein are used to mean "including but not limited to"; the use of the terms "first," "second," "third," etc. are used to describe different objects and do not imply an order or a ranking of importance of the objects.

[0098] In the description of the embodiments of the present application, the technical terms "first", "second" and the like are only used to distinguish different objects, and cannot be understood as indicating or implying relative importance or implicitly indicating the number, specific order or primary and secondary relationship of the indicated technical features. In the description of the embodiments of the present application, the meaning of "a plurality of" is two or more, unless otherwise explicitly and specifically limited.

[0099] Reference herein to "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment can be included in at least one embodiment of the application. The appearance of the phrase in various places in the specification are not necessarily all referring to the same embodiment, nor are they necessarily mutually exclusive or alternative embodiments to other embodiments. It is explicitly and implicitly understood by those skilled in the art that the embodiments described herein can be combined with other embodiments.

[0100] In the description of the embodiments of the present application, the term "and / or" is merely an association relationship of the associated objects, which means that there can be three relationships, for example, A and / or B, which can represent the three cases of A alone, A and B together, and B alone. In addition, the character " / " in this paper generally represents that the front and rear associated objects are "or" relationship.

[0101] In the description of the embodiments of the present application, the technical terms "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "circumferential", and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, which is only for the convenience of describing the embodiments of the present application and simplifying the description, and does not indicate or imply that the indicated device or element must have a particular orientation, be constructed in a particular orientation, be operated or used, and therefore cannot be understood as a limitation on the embodiments of the present application.

[0102] In the description of the embodiments of the present application, unless otherwise explicitly specified and limited, the technical terms "mounting", "connecting", "connecting", "fixing", and the like should be understood in a broad sense, for example, it can be fixedly connected, or it can be detachably connected, or it can be integrated; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the communication or interaction relationship between two elements. For those skilled in the art, the specific meaning of the above terms in the embodiments of the present application can be understood according to the specific circumstances.

[0103] In the description of the embodiments of the present application, unless otherwise explicitly specified and limited, the technical term "contact" should be understood in a broad sense, which can be direct contact or contact through an intermediate medium layer, which can be contact between two objects in contact without interaction force, or contact between two objects in contact with interaction force.

[0104] The above embodiments are only used to illustrate the technical solutions of the present application, and not to limit them; although the present application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that they can still modify the technical solutions recorded in the foregoing embodiments, or make equivalent replacement for part or all of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present application, and they should be covered in the scope of the claims and the description of the present application. Especially, as long as there is no structural conflict, each technical feature mentioned in each embodiment can be combined in any way. The present application is not limited to the specific embodiments disclosed in the paper, but includes all technical solutions falling within the scope of the claims.

Claims

1. An embolic protection device, comprising: The embolic protection device comprises: a delivery guide wire having a lumen structure; a support skeleton having a lumen structure, a proximal end of the support skeleton being connected to the delivery guide wire, the support skeleton having an expanded state and a contracted state; a resilient capsule arranged at a distal end of the support skeleton, an interior of the resilient capsule being in communication with the lumen structure of the support skeleton, a filling medium entering through the lumen structure of the delivery guide wire causes the resilient capsule to expand and expand, thereby driving the distal end of the support skeleton to expand; and a filter connected to the resilient capsule and changing shape with the resilient capsule; a distal end of the support skeleton is provided with a recessed portion recessed inward in a radial direction of the delivery guide wire, the resilient capsule is accommodated in the recessed portion, and the resilient capsule in the expanded state is not lower than a surface of the support skeleton; the support skeleton comprises a fixed portion having a lumen structure, a first support portion, and a plurality of support rods connected between the fixed portion and the first support portion, the fixed portion being connected to the delivery guide wire, the first support portion being connected to the resilient capsule, proximal ends of the support rods being connected to the fixed portion, distal ends of the support rods being movable ends, wherein the support skeleton is in an umbrella-shaped expanded state when the distal ends of the plurality of support rods are away from each other in the radial direction.

2. The embolic protection device according to claim 1, wherein the resilient capsule is arranged inside the filter, the filter is opened and the opening is directed to the delivery guide wire when the resilient capsule is in the expanded state, and the filter comprises a plurality of filter holes.

3. The embolic protection device according to claim 2, wherein in an axial direction of the delivery guide wire, the hole diameters of the plurality of filter holes gradually decrease from the proximal end to the distal end of the support skeleton.

4. The embolic protection device according to claim 1, wherein a surface of the filter has a drug coating, and the drug coating at least comprises an anti-vasospasm drug coating.

5. The embolic protection device according to claim 2, wherein the support skeleton comprises a second support portion extending in the axial direction of the delivery guide wire, and an end of the filter opposite to the opening is connected to the second support portion.

6. The embolic protection device according to claim 1, wherein the embolic protection device comprises an elastic member arranged at an end of the distal end of the support skeleton. The embolic protection device according to any one of claims 1 to 6.

7. An embolic protection system comprising:

8. The embolic protection system according to claim 7, wherein the embolic protection system comprises a delivery catheter, the embolic protection device is accommodated in the delivery catheter to be delivered to a target position and then released, a filling medium is delivered through the delivery guide wire to cause the support skeleton and the filter to expand; and / or the embolic protection system comprises a recovery catheter, the recovery catheter moves in a direction from the proximal end to the distal end of the support skeleton to compress the support skeleton and the resilient capsule, so that the embolic protection device is recovered into the recovery catheter. ​ ​ ​

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