Embolism protection device and embolism protection system

Abstract

The invention discloses an embolism protection device and an embolism protection system. The embolism protection device comprises a conveying guide wire with a cavity structure; the supporting framework is provided with a cavity structure, the near end of the supporting framework is connected to the conveying guide wire, and the supporting framework is arranged to be telescopic so that the far end of the supporting framework can have an expansion state and a contraction state; the elastic bag is arranged at the far end of the supporting framework, the elastic bag is communicated with the cavity structure of the supporting framework, the filling medium entering through the cavity structure of the conveying guide wire enables the elastic bag to be filled and expanded, and therefore the far end of the supporting framework is driven to be expanded; and the filtering piece is connected to the elastic bag and changes in shape along with the change of the elastic bag. The filtering piece is attached to the inner wall of the blood vessel after being expanded, and due to the fact that the elastic bag has certain elasticity, the blood vessel cannot be damaged 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 Art

[0002] When arterial stenting is performed to treat arterial stenosis, a large number of embolic fragments will be produced. These tiny embolic fragments enter the brain, lungs, heart, etc. with the blood flow and may cause serious diseases. In order to reduce the risk of such complications, people place embolic protection devices at the distal end of the stent insertion point to capture tiny emboli produced during the operation without affecting the normal flow of fluid in the blood vessels. After the arterial stent is successfully implanted, the embolic protection device is removed from the body together with the intercepted emboli through a retrieval catheter.

[0003] In the related art, in order to achieve better thrombus recovery, it is necessary to ensure that the embolic protection device fits the blood vessel after being released. However, due to the heterogeneity of the blood vessel diameter, the fit between the two is often not tight enough. Summary of the invention

[0004] In order to solve the above technical problems, the present application provides an embolic protection device and an embolic protection system that can fit tightly with the inner wall of a blood vessel.

[0005] The first aspect of the present application provides an embolic protection device, comprising: a delivery guidewire having a cavity structure; a support frame having a cavity structure, the proximal end of the support frame being connected to the delivery guidewire, the support frame having an expanded state and a contracted state; an elastic sac arranged at the distal end of the support frame, the elastic sac being connected to the cavity structure of the support frame, the filling medium entering through the cavity structure of the delivery guidewire causes the elastic sac to fill and expand, thereby driving the distal end of the support frame to expand; and a filter element connected to the elastic sac and changing in shape as the elastic sac changes.

[0006] In the present application, both the delivery guide wire and the support frame have a cavity structure. The delivery guide wire delivers the filling medium to expand the elastic capsule, thereby driving the support frame and the filter element to expand. After expansion, the elastic capsule and the filter element fit the inner wall of the blood vessel. Since the elastic capsule has a certain elasticity, it can fit well with the inner wall of the blood vessel without causing damage to the blood vessel. The filter element can change shape with the change of the elastic capsule and can be applied to different blood vessels.

[0007] In an embodiment of the present application, the distal end of the support frame is provided with a recessed portion recessed inwardly in the radial direction of the delivery guide wire, the elastic bag is accommodated in the recessed portion, and the elastic bag in a filled state is not lower than the surface of the support frame.

[0008] The recessed portion is recessed inwardly in the radial direction of the delivery guide wire, and such a recessed portion can limit the elastic capsule to a certain extent during the expansion process, so that the elastic capsule does not shift during the expansion process. When the elastic capsule reaches a certain transverse area (the transverse area in the axial direction), such a recessed portion 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 frame, ensuring the wall adhesion of the embolic protection device, and the contact between the soft elastic capsule and the blood vessel wall can reduce the risk of vascular spasm.

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

[0010] In an embodiment of the present application, the elastic bag is arranged inside the filter element. When the elastic bag is in a filled state, the filter element is opened and the opening faces the delivery guide wire. The filter element includes a plurality of filter holes.

[0011] In an embodiment of the present application, in the axial direction of the delivery guide wire, the apertures of the plurality of filter holes gradually decrease from the proximal end to the distal end of the support frame.

[0012] Such a filter hole aperture distribution arrangement can present a progressive embolus-capturing filter element, which can better and more completely capture embolus. Specifically, the aperture of the filter element at the proximal opening is larger and the aperture of the distal end is smaller, so the embolus captured at the opening will move to the distal end of the filter element as the blood flow flushes, and will not escape from the filter element from the distal end due to the smaller aperture of the distal end. Therefore, whether in the capturing process or the recovery process, the captured embolus will not flow out of the filter element.

[0013] In an embodiment of the present application, the filter element has a drug coating on its surface, and the drug coating at least includes an anti-vasospasm drug coating.

[0014] Anti-vasospastic drug coating can prevent vasospasm.

[0015] In an embodiment of the present application, the support skeleton includes a second support portion extending in the axial direction of the delivery guide wire, and an end of the filter element opposite to the opening is connected to the second support portion.

[0016] In an embodiment of the present application, the embolic protection device includes a first developing ring, which is arranged at the proximal end of the support frame to fix the support frame and the delivery guide wire; and / or the embolic protection device includes a second developing ring, which is sleeved on the second support portion, and the filter element is connected to the second developing ring.

[0017] The first developing ring can not only fix the supporting frame 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 can not only fix the supporting frame and the filter element, but also has a developing function for positioning the embolic protection device in the blood vessel.

[0019] In an embodiment of the present application, the embolic protection device includes an elastic member, and the elastic member is disposed at the distal end of the second support portion.

[0020] The elastic part is located at the front end of the entire supporting frame, which can play a role in vibration reduction and buffering, thereby preventing the device from causing damage to the blood vessels during the delivery / retrieval process.

[0021] In an embodiment of the present application, a filling control module is provided, and the filling control module is used to control the expansion range of the supporting skeleton by controlling the delivery amount of the filling medium.

[0022] By setting up a filling control module, the amount of filling medium can be adjusted according to the diameter of different blood vessels to achieve suitability for blood vessels of different diameters.

[0023] A second aspect of the present application provides an embolic protection system, comprising: the embolic protection device as described in the first aspect.

[0024] In an embodiment of the present application, the embolic protection system includes a delivery catheter, in which the embolic protection device is accommodated and released after being delivered to a target position, and a filling medium is delivered through the delivery guidewire to expand the support frame and the filter element; and / or the embolic protection system includes a retrieval catheter, which moves in a direction from the proximal end to the distal end of the support frame to compress the support frame and the elastic bag, thereby retrieving the embolic protection device to the retrieval catheter.

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

[0026] When the embolic protection device is retrieved, the filter can be located outside the retrieval catheter, which can be used in situations where there are many emboli to prevent the filter from entering the retrieval catheter and causing the captured emboli to overflow.

[0027] In the present application, both the delivery guide wire and the support frame have a cavity structure. The delivery guide wire delivers the filling medium to expand the elastic capsule, thereby driving the support frame and the filter element to expand. After expansion, the elastic capsule and the filter element fit the inner wall of the blood vessel. Since the elastic capsule has a certain elasticity, it can fit well with the inner wall of the blood vessel without causing damage to the blood vessel. The filter element can change shape with the change of the elastic capsule and can be applied to different blood vessels. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Various other advantages and benefits will become apparent to those of ordinary skill in the art by reading the detailed description of the preferred embodiments below. The accompanying drawings are only for the purpose of illustrating the preferred embodiments and are not to be considered as limiting the present application. Moreover, the same reference numerals are used throughout the drawings to represent the same components. In the drawings:

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

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

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

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

[0033] Figure 5 A schematic cross-sectional view of a support frame provided in some embodiments of the present application;

[0034] Figure 6 A schematic structural diagram of a cross section of a contact portion between an elastic bladder and a first supporting portion provided in some embodiments of the present application;

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

[0036] Figure 8 A schematic cross-sectional view of an embolic protection device provided in some embodiments of the present application located in a blood vessel;

[0037] Fig. 9 A schematic diagram of the structure of the embolic protection system for recovering the embolic protection device within a blood vessel provided in some embodiments of the present application.

[0038] Description of Reference Numerals

[0039] 1 embolic protection device; 2 blood vessel; 3 embolic protection system; 10 delivery guide wire; 101 filling entrance; 20 supporting frame; 21 fixing part; 22 first supporting part; 23 supporting rod; 24 recessed part; 25 second supporting part; 30 elastic balloon; 31 balloon pin; 40 filter element; 41 filter hole; 51 first developing ring; 52 second developing ring; 303 third developing ring; 60 elastic element; 71 delivery catheter; 72 retrieval catheter; 80 embolic fragments; 90 stenotic lesion; 91 dilated lesion. DETAILED DESCRIPTION

[0040] The following embodiments of the technical solution of the present application are described in detail in conjunction with the accompanying drawings. The following embodiments are only used to more clearly illustrate the technical solution of the present application, and are therefore only used as examples, and cannot be used to limit the scope of protection of the present application.

[0041] When arterial stenting is performed to treat arterial stenosis, a large number of embolic fragments will be produced. These tiny embolic fragments enter the brain, lungs, heart, etc. with the blood flow and may cause serious diseases. In order to reduce the risk of such complications, people place embolic protection devices at the distal end of the stent insertion point to capture tiny emboli produced during the operation without affecting the normal flow of fluid in the blood vessels. After the arterial stent is successfully implanted, the embolic protection device is removed from the body together with the intercepted emboli through a retrieval catheter.

[0042] In the related art, in order to achieve better thrombus recovery, it is necessary to ensure that the embolic protection device fits the blood vessel after being released. However, due to the heterogeneity of the blood vessel diameter, the fit between 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 rate is increasing year by year. When carotid artery stenosis is treated by carotid artery stenting surgery, more embolic fragments will be produced. These tiny embolic fragments enter the brain with the blood flow and may cause stroke or damage brain nerve function. In order to reduce the risk of such complications, people place embolic protection devices at the distal end of the stent insertion point to capture tiny emboli produced during the operation without affecting the normal flow of fluid in the blood vessels. After the carotid stent is successfully implanted, the embolic protection device is removed from the body together with the intercepted emboli through a retrieval catheter.

[0044] To solve the above technical problems, the present application provides an embolic protection device that can closely fit 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 embolic protection device provided by the present application includes: a delivery guide wire having a cavity structure; a support frame having a cavity structure, the proximal end of the support frame being connected to the delivery guide wire, the support frame being configured to be retractable so that the distal end of the support frame has an expanded state and a contracted state; an elastic sac being disposed at the distal end of the support frame, the elastic sac being connected to the cavity structure of the support frame, the elastic sac having a filling state and a pressure relief state that change with changes in the distal end of the support frame; and a filter element, connected to the elastic sac and changing in shape with changes in the elastic sac, wherein the filling medium entering through the cavity structure of the delivery guide wire causes the elastic sac to fill and expand, thereby driving the distal end of the support frame to expand.

[0046] In the present application, both the delivery guide wire and the support frame have a cavity structure. The delivery guide wire delivers the filling medium to expand the elastic capsule, thereby driving the support frame and the filter element to expand. After expansion, the elastic capsule and the filter element fit the inner wall of the blood vessel. Since the elastic capsule has a certain elasticity, it can fit well with the inner wall of the blood vessel without causing damage to the blood vessel. The filter element can change shape with the change of the elastic capsule and can be applied to different blood vessels.

[0047] Figure 1 A schematic diagram of a state of an embolic protection device provided in some embodiments of the present application when located at a first position in a blood vessel; Figure 2 A schematic diagram of a state of an embolic protection device provided in some embodiments of the present application when located at a first position in a blood vessel; Figure 3 A schematic diagram of the structure of an embolic protection device provided in some embodiments of the present application;

[0048] Figure 4 A schematic side view of the support frame provided in some embodiments of the present application; Figure 5 A schematic cross-sectional view of a support frame provided in some embodiments of the present application; Figure 6 A schematic structural diagram of a cross section of a contact portion between an elastic bladder and a first supporting portion provided in some embodiments of the present application; Figure 7 A schematic diagram of the structure of the embolic protection system provided in some embodiments of the present application for releasing the embolic protection device in a blood vessel; Figure 8 A schematic cross-sectional view of an embolic protection device provided in some embodiments of the present application located in a blood vessel; Fig. 9 A schematic diagram of the structure of the embolic protection system for recovering the embolic protection device within a blood vessel provided in some embodiments of the present application.

[0049] like Figures 1 to 6As shown, the embolic protection device 1 of the present application may include a delivery guidewire 10, a support frame 20, an elastic bag 30 and a filter 40. The delivery guidewire 10 may extend in the axial direction of the delivery guidewire 10, and the delivery guidewire 10 has a hollow cavity structure, and the cavity structure may extend in the axial direction of the delivery guidewire 10, and the delivery guidewire 10 delivers a filling medium to the support frame 20 through the cavity structure.

[0050] In the present application, the delivery guide wire 10 may 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 the filling medium can enter through the filling inlet 101. The distal end of the delivery guide wire 10 may be connected to the support frame 20.

[0051] In the present application, the material of the delivery guide wire 10 can be a metal such as stainless steel or shape memory alloy. The diameter of the delivery guide wire 10 varies in the range of 0.2mm-0.4mm, and the diameter of the delivery guide wire 10 can be 0.25mm, 0.3mm, and 0.35mm. The delivery guide wire 10 is provided with a pressure-filling and pressure-relieving cavity of the elastic capsule 30, which is connected to the cavity of the support frame 20, and the proximal end of the delivery guide wire 10 is connected with a 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 polymer lubricating coating to reduce the resistance during the pushing process of the delivery guide wire 10. Specifically, the polymer lubricating coating can be a coating in the prior art, which is not specifically limited in this application, and can be designed and selected by those skilled in the art according to actual conditions. Coating the polymer lubricating coating on the surface of the delivery guide wire 10 reduces the difficulty of pushing, so that the operator can push the guide wire to the target position more easily and accurately, and improves the convenience and accuracy of the surgical operation. At the same time, reducing resistance helps to reduce friction and damage to the inner wall of the blood vessel, and reduces the risk of vascular complications. In addition, the smooth pushing process can shorten the operation time, reduce the patient's pain and risks during the operation, and also improve the efficiency and safety of the operation.

[0052] In the present application, the support skeleton 20 may have a hollow cavity structure, and the filling medium entering through the cavity structure of the delivery guide wire 10 may enter the cavity structure of the support skeleton 20 to expand the distal end of the support skeleton 20 .

[0053] In the present application, the support frame 20 can form a pressure-inflating and pressure-releasing cavity of the elastic capsule 30 together with the hollow cavity of the delivery guide wire 10. The support frame 20 can be formed by a shape memory metal such as nickel-titanium alloy through a hot forming process. After the delivery catheter is withdrawn at a suitable position, the expansion of the support frame 20 is driven by the expansion of the elastic capsule 30, providing good support and wall adhesion to the filter element 40.

[0054] In the embodiment of the present application, the support frame 20 may include a fixing portion 21, a first supporting portion 22, and a plurality of supporting rods 23 connected between the fixing portion 21 and the first supporting portion 22. The fixing portion 21 is connected to the distal end of the delivery guide wire 10, the first supporting portion 22 may be connected to the elastic capsule 30, the proximal end of the supporting rod 23 is connected to the fixing portion 21, and the distal end of the supporting rod 23 is a movable end.

[0055] In the embodiment of the present application, the fixing part 21, the support rod 23, and the first support part 22 may all be provided with a cavity structure, and the cavity structures in the fixing part 21, the support rod 23, and the first support part 22 may be connected in sequence to allow the filling medium to pass through.

[0056] When the distal ends of the plurality of support rods 23 are radially away from each other, the support frame 20 is in an umbrella-shaped expansion state, such as Figures 1 to 3 The support frame 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 frame 20 is in a contracted state. Figure 7 and Fig. 9 The supporting frame 20 is shown in a schematic diagram in a contracted state.

[0057] Each support rod 23 is provided with a pressure filling and releasing cavity (cavity structure) connected to the elastic bag 30. The hollow cavity (cavity structure) of each support rod 23 finally intersects with the hollow cavity (cavity structure) in the delivery guide wire 10, and together with the filling inlet 101, constitutes a control system of the elastic bag 30.

[0058] like Figure 6 As shown, the elastic sac 30 is located between the first support portion 22, and the recessed portion 24 and the first support portion 22 jointly limit the position of the elastic sac 30. The balloon pin 31 is connected to the hollow cavity of the support rod 23 to transmit the filling medium to control the inflation and deflation pressure of the elastic sac 30.

[0059] In this application, if Figures 1 to 3 As shown, the number of the support rods 23 can be set to 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 the support rods 23 can be adaptively adjusted to other numbers.

[0060] In this application, if Figure 3 As shown, when the support skeleton 20 is in a released state, the spaces in the radial direction of the fixing portion 21 of the support skeleton 20, the transition portion composed of a plurality of support rods 23, and the annular first support portion 22 become larger successively (similar to an umbrella shape). When the radial space of the annular first support portion 22 reaches the maximum, it is beneficial to the recovery of the embolic protection device 1 and takes into account the efficiency of embolic filtering.

[0061] In the embodiments of the present application, Figure 2 and Figure 3 As shown, the distal end of the support frame 20 is provided with a recessed portion 24 recessed inwardly in the radial direction of the delivery guide wire, and the elastic bag 30 can be accommodated in the recessed portion 24.

[0062] In the embodiments of the present application, Figure 2 and Figure 3 As shown, the first support portion 22 may be annular to better fit the inner wall of the blood vessel 2. The first support portion 22 may be recessed inwardly in the radial direction of the delivery guide wire to form a recessed portion 24, and the elastic capsule 30 may be accommodated in the recessed portion 24.

[0063] like Figures 1 to 3 As shown, the elastic bag 30 can be arranged at the distal end of the support frame 20, and the cavity structure of the elastic bag 30 is connected to the cavity structure of the support frame 20. The filling medium entering the cavity structure through the delivery guide wire makes the elastic bag fill and expand, thereby driving the distal end of the support frame to expand.

[0064] In the embodiment of the present application, the elastic balloon 30 may be an annular balloon made of a material with good compliance such as polyurethane, etc. The annular balloon can ensure the vascular wall adhesion of the embolic protection device, and avoid the problem of gaps in the curved blood vessels and the escape of tiny emboli in the traditional embolic protection device.

[0065] like Figure 1 to Figure 2 As shown, when the support frame 20 is in an expanded state, the filling medium can enter the elastic bag 30 through the cavity structure of the support frame 20, and the elastic bag 30 is filled accordingly. Figure 1 and Figure 2 As shown, by filling the elastic bag 30 , the elastic bag 30 can fit with the inner wall of the blood vessel 2 , thereby achieving close fit between the embolic protection device and the inner wall of the blood vessel 2 .

[0066] Figure 1 and Figure 2 The states of the embolic protection device at the first position in different blood vessels are shown respectively. Figure 1 and Figure 2 It is explained that the elastic capsule 30 is located at different vascular lesion locations, and different vascular lesion locations have different inner diameters. Since the elastic capsule 30 is filled and has good compliance, the elastic capsule 30 fits the inner wall of blood vessels with different inner diameters, so that the embolic protection device 1 can show good wall adhesion at different vascular locations. It should be pointed out that the first position of the present application is the setting position of the embolic protection device 1 in the blood vessel.

[0067] In the embodiment of the present application, the embolic protection device 1 may include a filling control device (not shown), which may be used to control the expansion range of the support frame by controlling the delivery amount of the filling medium. Figure 1 to Figure 2As shown, the filling control device can control the filling state of the elastic bag 30 so that the surface of the elastic bag 30 is just flush with the surface of the first support part 22. Such a setting can achieve better fit with the inner wall of the blood vessel 2 to adapt to the following conditions: Figure 1 and Figure 2 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 varies greatly. The configuration of the present application can meet the various blood vessel conditions of the carotid artery. The filling control device can use a charging pump or an injection device (such as a syringe) to identify the delivery amount of the filling medium or the pressure of the elastic bag 30 through a scale or pressure display.

[0068] It should be noted that the present disclosure is not limited to the configuration in which the surface of the elastic sac 30 is exactly flush with the surface of the first support portion 22. In some embodiments, the surface of the elastic sac 30 may protrude from the surface of the first support portion 22 to adapt to different blood vessel conditions.

[0069] In the embodiment of the present application, the recessed portion 24 is recessed inwardly in the radial direction of the delivery guide wire 10, and such a recessed portion 24 can be limited to a certain extent during the expansion process of the elastic capsule 30, so that the elastic capsule 30 does not shift during the expansion process. When the elastic capsule 30 reaches a certain transverse area (the transverse area in the axial direction), such a recessed portion 24 can also allow the elastic capsule 30 to expand more in the radial direction, so that the elastic capsule 30 can fill the gap between the inner wall of the blood vessel 2 and the support frame 20, ensuring the wall adhesion of the embolic protection device 1, and the soft elastic capsule 30 contacts the inner wall of the blood vessel 2 to reduce the risk of vascular spasm.

[0070] In the embodiment of the present application, the elastic capsule 30 may have a certain elasticity, for example, it may be made of a compliant material such as polyurethane. The elastic capsule 30 is fixed in the recessed portion 24 of the support frame 20 by mechanical positioning and glue bonding. The elastic capsule 30 may have a filling channel, and the filling channel inside the elastic capsule 30 may be connected to the hollow cavity of each support rod 23. The expansion and contraction of the support frame 20 is controlled by the filling and release of the elastic capsule 30.

[0071] In the embodiment of the present application, the filter 40 can be connected to the elastic bladder 30 and can change shape with the elastic bladder 30. For example, in some embodiments, the elastic bladder 30 can be disposed inside the filter 40, that is, the filter 40 is located outside the elastic bladder 30. As the elastic bladder 30 is filled, the filter 40 can fit the inner wall of the blood vessel 2, so that emboli can be captured to the greatest extent.

[0072] In some embodiments, the open end of the filter 40 may be coated on the outside of the distal end of the support frame 20. In some embodiments, the open end of the filter 40 may be coated on the outside of the distal end of the support frame 20 and the outside of the elastic bag 30.

[0073] In the embodiments of the present application, Figures 1 to 3 As shown, when the elastic bag 30 is in the inflated state, the filter element 40 is opened and the opening faces the delivery guide wire 10 , and the filter element 40 may include a plurality of filtering holes 41 .

[0074] In the embodiments of the present application, Figures 1 to 3 As shown, in the axial direction of the delivery guide wire 10 , the apertures of the plurality of filter holes 41 gradually decrease from the proximal end to the distal end of the support skeleton 20 .

[0075] Such a filter hole aperture distribution arrangement can present a progressive embolic capture filter 40, which can better and more completely capture emboli. Specifically, the aperture of the filter at the proximal opening is larger and the aperture at the distal end is smaller, so the emboli captured at the opening will move to the distal end of the filter as the blood flow washes, and will not escape from the filter from the distal end due to the smaller aperture at the distal end. Therefore, whether in the capture process or the recovery process, the captured emboli will not flow out of the filter 40.

[0076] It should be pointed out that the pore size of the filter holes on the filter element of the present disclosure is not limited to that in the above embodiments. In some embodiments, the pore size of multiple filter holes is consistent.

[0077] During the operation, the stimulation of the carotid artery by the embolic protection device can easily cause carotid vasospasm. In the embodiment of the present application, the surface of the filter element 40 has a drug coating, and the drug coating at least includes an anti-vasospasm drug coating. For example, the drug coating may include atropine, papaverine hydrochloride, heparin and other water-soluble antispasm drug coatings. This means that during the operation, antispasm drugs can be provided to the blood vessels in a timely and targeted manner, effectively alleviating the problem of carotid vasospasm caused by the stimulation of the device, and further reducing the risk of surgery and the probability of complications.

[0078] In an embodiment of the present application, the filter element 40 can be an umbrella-shaped membrane integrally formed of a polymer material, and the umbrella-shaped membrane is evenly opened with holes by laser or other processes, which can capture emboli without affecting the circulation of liquid in the cavity. The umbrella-shaped membrane can be made of polymer materials such as TPU and PA. The umbrella-shaped membrane includes an opening end of the filter screen and a tail end of the filter screen. The aperture is gradually reduced from the opening end of the filter screen to the tail end of the filter screen. In an embodiment of the present application, the aperture range of the filter hole 41 can be 100-230 microns. For example, the aperture of the filter hole 41 can be 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220 microns.

[0079] In an embodiment of the present application, the support skeleton 20 may further include a second support portion 25 extending in the axial direction of the delivery guide wire 10 , and the end of the filter element 40 opposite to the opening is connected to the second support portion 25 , that is, the distal end of the filter element 40 is connected to the second support portion 25 .

[0080] The second supporting portion 25 is provided to not only enhance the structural strength of the supporting frame 20 , but also can be used to fix the filter element 40 .

[0081] In the embodiment of the present application, the embolic protection device 1 may include a first developing ring 51, which may be disposed at the proximal end of the support frame 20 to fix the support frame 20 and the delivery guide wire 10. Figure 3 As shown, the first developing ring 51 can fix the fixing portion 21 of the support frame 20 to the delivery guide wire 10. For example, the first developing ring 51 can fix the fixing portion 21 of the support frame 20 to 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, platinum, etc.

[0082] The first developing ring 51 can not only fix the supporting frame 20 and the delivery guide wire 10 , but also has a developing function for positioning the embolic protection device 1 in the blood vessel.

[0083] In the embodiment of the present application, the embolic protection device 1 may include a second developing ring 52, which may be slidably sleeved on the second support portion 25, and the filter element 40 is connected to the second developing ring 52. The second developing ring 52 may be used to fix the support frame 20 and the filter element 40, which is beneficial to improving the structural stability of the embolic protection device 1. The second developing ring 52 may be composed of a radiopaque metal ring. The second developing ring 52 may be composed of a metal material with good developing effect such as gold or platinum.

[0084] The second developing ring 52 can not only fix the support frame 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 frame 20 and the filter element 40, the second developing ring 52 slides on the second support portion 25 to reduce the resistance of compressing the support frame 20 and the filter element 40, so that the support frame 20 can be smoothly received in the delivery catheter or the recovery catheter.

[0085] In this application, if Figure 5 As shown, the embolic protection device 1 may include a third developing ring 303, and a circle of the third developing ring 303 is also arranged around the first supporting portion 22 of the umbrella-shaped supporting frame 20 to indicate the position of the first supporting portion 22, so as to facilitate the positioning of the first supporting portion 22 when the embolic protection device is recovered. When there are too many emboli, only the first supporting portion 22 can enter the recovery conduit during the recovery process to avoid the leakage of emboli. In the embodiment where the supporting frame 20 is umbrella-shaped, it can be considered that the first supporting portion 22 is at the umbrella mouth position, and at the same time, the first supporting portion 22 is also located at the opening position of the filter element 40. When there are many emboli captured, it is not convenient to recover all the filter element 40 into the recovery conduit. Then, only the first supporting portion 22 or part of the filter element 40 can be recovered into the recovery conduit to avoid the leakage of emboli, and the leakage of emboli caused by squeezing during the recovery process can also be avoided.

[0086] In the embodiments of the present application, Figure 1 As shown, the embolic protection device 1 may be provided with a first developing ring 51 and a second developing ring 52 .

[0087] In the embodiment of the present application, the embolic protection device 1 includes an elastic member 60, which can be disposed at the distal end of the support frame 20. For example, the elastic member 60 can be disposed at the distal end of the second support portion 25.

[0088] The elastic member 60 can be a spring tip 3D printed from a flexible material doped with a developing material. The developing material is a material that can be developed under X-ray irradiation. This allows the position of the distal end of the embolic protection device 1 to be easily observed to facilitate determination of whether the destination has been reached. The elastic member 60 can be formed by connecting an elastic member such as silicone with a spring. The flexible material can be a soft material such as silicone and polyurethane, which not only provides cushioning performance, but also has good biocompatibility, reduces the risk of postoperative complications, and helps the patient recover quickly.

[0089] At the same time, the integrated design reduces the connection gaps and potential breaking points between components, and improves the stability and reliability of the structure. In addition, 3D printing technology can accurately control the shape, size and elastic properties of the spring, so that it can better adapt to the bends and narrow parts of the blood vessels, further enhancing the protective effect. Optionally, the developing material includes at least one metal material selected from platinum, tungsten, bismuth and barium, or an alloy material of at least two of the above metal materials, or a polymer material added with at least one of the above elements. All of the above materials have good developing effects and good elasticity.

[0090] The elastic member 60 is located at the front end of the entire support frame 20. In the present embodiment, the elastic member 60 is located at the farthest end of the delivery guide wire 10. When encountering resistance, the elastic member 60 can avoid it by bending and rebounding, thereby preventing the device from causing damage to the blood vessel during the delivery / retrieval process.

[0091] In the embodiments of the present application, Figure 7 and Figure 8 As shown, the embolic protection system 3 may include an embolic protection device 1 and a delivery catheter 71. Figure 7 As shown, the embolic protection device 1 can be housed in a delivery catheter 71 to be delivered to a target location. Figure 8 As shown, when the embolic protection device 1 is delivered to the target position, the embolic protection device 1 is released. After the release is complete, a filling medium can be delivered through the delivery guide wire 10 to expand the support frame 20 and the elastic bag 30 and drive the filter 40 to expand.

[0092] Due to the arrangement of the elastic bag 30 and the filter element 40 , the delivery guide wire 10 can push the filter element 40 to the location of the carotid artery stenosis lesion, and the delivery guide wire 10 does not affect the morphology of the blood vessel.

[0093] like Fig. 9 As shown, the embolic protection system 3 may include an embolic protection device 1 and a retrieval catheter 72 . The retrieval catheter 72 may move along the proximal to distal direction of the support skeleton 20 to compress the support skeleton 20 and the elastic bag 30 , thereby retrieving the embolic protection device 1 to the retrieval catheter 72 .

[0094] In the embodiment of the present application, when the embolic protection device 1 is recovered to the recovery catheter 72 , when there are fewer embolic fragments 80 in the filter element 40 , the filter element 40 can be completely accommodated in the recovery catheter 72 , and the embolic fragments 80 will not escape from the filter element 40 .

[0095] In some embodiments, when there are a large number of embolic fragments 80 in the filter element 40, when the embolic protection device 1 is recovered to the recovery catheter 72, the filter element 40 may not be completely contained in the recovery catheter 72, that is, when the embolic protection device 1 is recovered, the filter element 40 may be located outside the recovery catheter 72, but the gathering of the support rods 23 enables the embolic fragments 80 to be completely clamped by the filter element 40 and will not escape from the filter element 40.

[0096] like Figure 8 and Fig. 9 ,exist Figure 8 After balloon dilatation or stent implantation, the stenotic lesion 90 is reduced to a dilated lesion 91, and all embolic fragments 80 are intercepted by the filter element 40. The filter element 40 is then placed in the recovery catheter 72, and the embolic fragments 80 will not escape from the filter element 40.

[0097] In order to enable the filter element to be smoothly transported and recovered, the embolic protection device of the present application can be used in conjunction with a transport / recovery catheter known in the art. The embolic protection device can be compressed and loaded in the transport catheter. When the embolic protection device reaches the lesion release position, a portion of the transport guide wire is withdrawn, and the support frame will initially expand to a stretched state. Physiological saline is injected through the filling inlet of the transport guide wire to expand the elastic capsule. Due to the limiting effect of the recessed portion, the elastic capsule will expand more radially, filling the gap between the vascular wall and the umbrella-shaped support frame to achieve good wall adhesion. When recovering, the filling control device is connected to the filling inlet 101 of the proximal end of the transport guide wire 10, and the filling medium in the support frame 20 and the elastic capsule 30 is extracted to shrink the elastic capsule 30. At this time, the elastic capsule is almost in the recessed portion, which greatly reduces the resistance of the elastic capsule recovery. The recovery catheter pushes the three support rods of the support frame forward, thereby driving the compression of the first support part. The third developing ring can be observed to determine whether the opening of the support frame is retracted into the recovery catheter. The filter element may not be completely retracted into the recovery catheter to avoid excessive squeezing of the filter screen and leakage of emboli. Finally, the device is withdrawn from the body.

[0098] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by technicians in the technical field to which this application belongs; the terms used herein are only for the purpose of describing specific embodiments and are not intended to limit this application; the terms "including" and "having" in the specification and claims of this application and the above-mentioned figure descriptions and any variations thereof are intended to cover non-exclusive inclusions.

[0099] In the description of the embodiments of the present application, the technical terms "first", "second", etc. 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 "multiple" is more than two, unless otherwise clearly and specifically defined.

[0100] Reference to "embodiments" herein means that a particular feature, structure, or characteristic described in conjunction with the embodiments may be included in at least one embodiment of the present application. The appearance of the phrase in various locations in the specification does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment that is mutually exclusive with other embodiments. It is explicitly and implicitly understood by those skilled in the art that the embodiments described herein may be combined with other embodiments.

[0101] In the description of the embodiments of the present application, the term "and / or" is only a description of the association relationship of associated objects, indicating that three relationships may exist. For example, A and / or B can represent: A exists alone, A and B exist at the same time, and B exists alone. In addition, the character " / " in this article generally indicates that the associated objects before and after are in an "or" relationship.

[0102] In the description of the embodiments of the present application, the orientation or position relationship indicated by technical terms such as "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", and "circumferential" are based on the orientation or position relationship shown in the accompanying drawings. They are only for the convenience of describing the embodiments of the present application and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed, operated or used in a specific orientation. Therefore, they should not be understood as limitations on the embodiments of the present application.

[0103] In the description of the embodiments of the present application, unless otherwise clearly specified and limited, technical terms such as "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, and it can be the internal connection of two elements or the interaction relationship between two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the embodiments of the present application can be understood according to the specific circumstances.

[0104] In the description of the embodiments of the present application, unless otherwise clearly specified and limited, the technical term "contact" should be understood in a broad sense, and may be direct contact or contact through an intermediate medium layer. It may be contact with essentially no interaction force between the two contacting parties, or it may be contact with interaction force between the two contacting parties.

[0105] The above embodiments are only used to illustrate the technical solutions of the present application, rather than to limit them; although the present application is described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein by equivalents; 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 all be included in the scope of the claims and specification of the present application. In particular, as long as there is no structural conflict, the various technical features mentioned in the various embodiments can be combined in any way. The present application is not limited to the specific embodiments disclosed herein, but includes all technical solutions that fall within the scope of the claims.

Claims

1. An embolic protection device, characterized in that: include: A delivery guide wire having a cavity structure; A support frame having a cavity structure, wherein the proximal end of the support frame is connected to the delivery guide wire, and the support frame has an expanded state and a contracted state; An elastic sac is arranged at the distal end of the support frame, the interior of the elastic sac is communicated with the cavity structure of the support frame, and the filling medium entering through the cavity structure of the delivery guide wire causes the elastic sac to fill and expand, thereby driving the distal end of the support frame to expand; as well as The filter element is connected to the elastic bag and changes in shape as the elastic bag changes.

2. The embolic protection device according to claim 1, characterized in that: The distal end of the support frame is provided with a recessed portion recessed inwardly in the radial direction of the delivery guide wire, the elastic bag is accommodated in the recessed portion, and the elastic bag in a filled state is not lower than the surface of the support frame.

3. The embolic protection device according to claim 1 or 2, characterized in that: The support frame includes a fixing portion having a cavity structure, a first supporting portion, and a plurality of supporting rods connected between the fixing portion and the first supporting portion, wherein the fixing portion is connected to a delivery guide wire, the first supporting portion is connected to the elastic bag, the proximal end of the supporting rod is connected to the fixing portion, and the distal end of the supporting rod is a movable end. Wherein, when the distal ends of the plurality of support rods are away from each other in the radial direction, the support frame is in an umbrella-shaped expansion state.

4. The embolic protection device according to claim 1 or 2, characterized in that: The elastic bag is arranged inside the filter element. When the elastic bag is in a filled state, the filter element is opened and the opening faces the delivery guide wire. The filter element includes a plurality of filter holes.

5. The embolic protection device according to claim 4, characterized in that: In the axial direction of the delivery guide wire, the apertures of the plurality of filter holes gradually decrease from the proximal end to the distal end of the support frame.

6. The embolic protection device according to claim 1, characterized in that: The filter element has a drug coating on its surface, and the drug coating at least includes an anti-vasospasm drug coating.

7. The embolic protection device according to claim 4, characterized in that: The support frame includes a second support portion extending in the axial direction of the delivery guide wire, and an end of the filter element opposite to the opening is connected to the second support portion.

8. The embolic protection device according to claim 1, characterized in that: The embolic protection device comprises an elastic member, and the elastic member is arranged at the end of the distal end of the supporting frame.

9. An embolic protection system, characterized in that: include: The embolic protection device according to any one of claims 1 to 8.

10. The embolic protection system according to claim 9, characterized in that: The embolic protection system comprises a delivery catheter, wherein the embolic protection device is contained in the delivery catheter so as to be delivered to a target location and then the embolic protection device is released, and a filling medium is delivered through the delivery guide wire to expand the support frame and the filter element; and / or The embolic protection system includes a retrieval catheter, which moves along the direction from the proximal end to the distal end of the support frame to compress the support frame and the elastic bag, so that the embolic protection device is retrieved to the retrieval catheter.

Images