Carotid embolic protection device

Abstract

The present invention provides a carotid artery embolism protection device, comprising a push guidewire, a support ring assembly, a guidewire assembly, and a filter. The push guidewire is provided with a receiving cavity, the support ring assembly is fixed to the push guidewire, and the support ring assembly comprises a support ring body, a hollow cannula, and an electrostrictive assembly. The support ring body has a deformable structure, the hollow cannula covers the support ring body and the electrostrictive assembly, and the electrostrictive assembly is located outside the support ring body. The outer diameter of the support ring assembly can be changed by adjusting the electric field of the electrostrictive assembly. The guidewire assembly is disposed in the receiving cavity and passes through the push guidewire and the hollow cannula to connect to the electrostrictive assembly. The filter is connected to the hollow cannula. The present invention enhances the wall adhesion of the support ring assembly, improves surgical safety, and enhances the convenience and efficiency of device recovery.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a carotid artery embolism protection device. Background Art

[0002] During interventional cerebrovascular and lower limb arterial surgeries, the manipulation of surgical instruments can cause platelets in the blood to form various aggregates, such as emboli, bacterial aggregates, and tiny tissue debris, or cause atherosclerotic plaque fragments and particles to detach from arterial walls. Once these harmful components travel through the bloodstream, they can invade the brain and other critical arteries in the body, potentially leading to serious complications such as cerebral vascular obstruction and below-the-knee embolism.

[0003] To effectively prevent complications caused by embolic particles, advanced distal protection devices are often required during surgery. Their primary function is to intercept plaque fragments traveling down the bloodstream, thereby blocking potential pathways for embolism. Common distal protection devices currently on the market often utilize distal filter systems, such as Accunet (Abbott) and Filterwire (Boston Scientific), which have been widely used clinically.

[0004] Existing distal protection devices commonly use shape-memory metals as their support structure. However, these materials have weak support strength and can easily form gaps between the filter opening and the vessel wall, allowing some thrombi to escape into the distal vessels and cause postoperative complications. Chinese patent CN114271989A discloses a solution that fixes a water-swellable material to the outside of the support ring to enhance adherence to the vessel wall. However, the water-swelling material cannot retract after expansion, which can make it difficult to recycle the protection device.

[0005] Therefore, it is necessary to provide a carotid artery embolism protection device that can both enhance the wall adhesion effect and improve the device recovery efficiency. Summary of the Invention

[0006] The object of the present invention is to provide a carotid artery embolism protection device that can enhance the wall adhesion effect and improve the device recovery efficiency.

[0007] To achieve the above objectives, the present invention provides a carotid artery embolism protection device, comprising a push guidewire, a support ring assembly, a guide wire assembly, and a filter. The push guidewire is provided with a housing cavity, the support ring assembly is fixed to the push guidewire, the support ring assembly comprises a support ring body, a hollow sleeve, and an electrostrictive assembly, the support ring body having a deformable structure, the hollow sleeve covering the support ring body and the electrostrictive assembly, the electrostrictive assembly being located outside the support ring body, and the outer diameter of the support ring assembly being changed by adjusting the electric field of the electrostrictive assembly; the guide wire assembly is disposed in the housing cavity and passes through the push guidewire and the hollow sleeve to be connected to the electrostrictive assembly; and the filter is connected to the hollow sleeve.

[0008] Preferably, the electrostrictive component includes a first electrode, a second electrode and an electrostrictive film, and the first electrode and the second electrode are arranged on both sides of the electrostrictive film.

[0009] Preferably, the guide wire assembly includes a first guide wire and a second guide wire, the wire body of the first guide wire passes through the push guide wire and the hollow cannula to be connected to the first electrode, and the wire body of the second guide wire passes through the push guide wire and the hollow cannula to be connected to the second electrode.

[0010] Preferably, the hollow sleeve, the first electrode, the electrostrictive film and the second electrode are connected together by bonding.

[0011] Preferably, the carotid artery embolism protection device further includes a first fixing member, which is fixedly connected between the push guide wire and the hollow cannula.

[0012] Preferably, a connecting hole is provided inside the first fixing member, and the guide wire assembly passes through the push guide wire, the connecting hole and the hollow sleeve in sequence.

[0013] Preferably, the support ring body is made of shape memory alloy, and the hollow sleeve is made of elastic polymer material.

[0014] Preferably, the filter screen has an open end and a closed end, the open end is connected to the hollow sleeve, and the closed end is connected to the push guide wire.

[0015] Preferably, the filter screen is made of a punched polymer membrane material or woven from a self-expanding material.

[0016] Preferably, the pore size of the filter screen is in the range of 50-150 microns.

[0017] Preferably, the carotid embolism protection device also includes a delivery catheter. When the carotid embolism protection device is pushed, the pushing guide wire, the support ring assembly and the filter are received inside the delivery catheter, and the inner wall of the delivery catheter squeezes the support ring assembly so that the support ring assembly is deformed and folded in a direction close to the pushing guide wire.

[0018] Compared to the prior art, the carotid artery embolic protection device of the present invention employs a guidewire assembly disposed within the guidewire receiving cavity. Furthermore, the support ring assembly comprises a hollow cannula, a support ring body, and an electrostrictive assembly, and the guidewire assembly is connected to the electrostrictive assembly. Consequently, a specific electric field can be applied to the electrostrictive assembly via the guidewire assembly, causing the electrostrictive assembly to expand toward the inner wall of the blood vessel and abut against the hollow cannula, thereby changing the outer diameter of the support ring assembly. This increases the outer diameter of the support ring assembly and allows it to adhere to the inner wall of the blood vessel, thereby enhancing its adherence to the wall and preventing thrombus from escaping through the gap between the support ring assembly and the blood vessel during surgery, thereby improving surgical safety. After the procedure, the direction of the electric field applied by the guidewire assembly to the electrostrictive assembly can be changed to change its outer diameter, causing it to contract. This improves the convenience and efficiency of device retrieval and reduces the risk of damage to the patient's blood vessels. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 It is a structural schematic diagram of the carotid artery embolism protection device of the present invention, in which the push guide wire, the support ring assembly and the filter screen are accommodated in the delivery catheter.

[0020] Figure 2 It is a schematic structural diagram of the carotid artery embolism protection device of the present invention when the support ring assembly is attached to the inner wall of the blood vessel.

[0021] Figure 3 It is a radial cross-sectional view of the support ring assembly of the present invention.

[0022] Figure 4 yes Figure 3 Enlarged view of point A in the middle.

[0023] Figure 5 The figure is a schematic axial half-section diagram of the electrostrictive membrane of the carotid artery embolism protection device of the present invention when no power is supplied.

[0024] Figure 6 The figure is a schematic axial half-section diagram of the electrostrictive membrane of the carotid artery embolism protection device of the present invention when it expands upon power-on.

[0025] Figure 7 The figure is a schematic axial half-section diagram of the electrostrictive membrane of the carotid artery embolism protection device of the present invention when it contracts upon power-on. DETAILED DESCRIPTION

[0026] In order to explain the technical content and structural features of the present invention in detail, the following is a further description in conjunction with the embodiments and the accompanying drawings.

[0027] See also Figures 1 to 7 The carotid artery embolic protection device 100 of the present invention includes a push guidewire 1, a support ring assembly 2, a guidewire assembly 3, and a filter 4. The push guidewire 1 is provided with a receiving cavity 11. The support ring assembly 2 is fixed to the push guidewire 1. The support ring assembly 2 includes a support ring body 21, a hollow sleeve 22, and an electrostrictive assembly 26. The support ring body 21 has a deformable structure. The hollow sleeve 22 covers the support ring body 21 and the electrostrictive assembly 26. The electrostrictive assembly 26 is located outside the support ring body 21. The outer diameter of the electrostrictive assembly 26 is changed by adjusting the electric field of the electrostrictive assembly 26. The guidewire assembly 3 is disposed in the receiving cavity 11 and passes through the push guidewire 1 and the hollow sleeve 22 to be connected to the electrostrictive assembly 26. The filter 4 is connected to the hollow sleeve 22.

[0028] The carotid artery embolic protection device 100 of the present invention comprises a guidewire assembly 3 disposed within the receiving cavity 11 of the push guidewire 1. Furthermore, the support ring assembly 2 comprises a hollow cannula 22, a support ring body 21, and an electrostrictive assembly 26, and the guidewire assembly 3 is connected to the electrostrictive assembly 26. Therefore, a specific electric field can be applied to the electrostrictive assembly 26 via the guidewire assembly 3, causing the electrostrictive assembly 26 to expand toward the inner wall of the blood vessel 200 and abut against the hollow cannula 22, thereby changing the outer diameter of the support ring assembly 2. This increases the outer diameter of the support ring assembly 2 and allows it to adhere to the inner wall of the blood vessel 200. This enhances the wall adhesion of the support ring assembly 2, prevents thrombus 201 from escaping through the gap between the support ring assembly 2 and the blood vessel 200 during surgery, and thereby improves surgical safety. After the operation, the direction of the electric field applied by the wire assembly 3 to the electrostrictive assembly 26 can be changed to change the outer diameter of the electrostrictive assembly 26, causing the support ring assembly 2 to shrink, thereby improving the convenience and efficiency of device recovery and reducing the risk of damage to the patient's blood vessels 200.

[0029] The principle of adjusting the electric field of the electrostrictive assembly 26 to change the outer diameter of the support ring assembly 2 is as follows: increasing the electric field causes the electrostrictive assembly 26 to expand. Within a certain range, the greater the electric field, the greater the expansion of the electrostrictive assembly 26, thereby increasing the outer diameter of the support ring assembly 2. The magnitude of the applied electric field can be determined based on the distance between the support ring assembly 2 and the inner wall of the blood vessel 200. Similarly, by changing the direction of the electric field, increasing the electric field, the electrostrictive assembly 26 contracts. Within a certain range, the greater the electric field, the greater the contraction of the electrostrictive assembly 26, thereby decreasing the outer diameter of the support ring assembly 2, making it easier to store within the retrieval catheter.

[0030] In one embodiment, the shape of the support ring body 21 matches the shape of the proximal opening of the filter screen 4 , and can be circular, elliptical, or a circular shape such as an open ring.

[0031] See also Figure 3 and Figure 4 In one embodiment, the electrostrictive element 26 includes a first electrode 23 , a second electrode 24 and an electrostrictive film 25 . The first electrode 23 and the second electrode 24 are disposed on both sides of the electrostrictive film 25 .

[0032] See also Figure 3 and Figure 4 In one embodiment, the wire assembly 3 includes a first wire 31 and a second wire 32. The wire body of the first wire 31 passes through the push guide wire 1 and the hollow sleeve 22 to be connected to the first electrode 23, and the wire body of the second wire 32 passes through the push guide wire 1 and the hollow sleeve 22 to be connected to the second electrode 24.

[0033] Preferably, in one embodiment, the surfaces of the first wire 31 and the second wire 32 are both coated with an insulating layer or a non-conductive material (such as fluorinated ethylene propylene), so that the first wire 31 and the second wire 32 are electrically insulated from each other to improve safety.

[0034] See also Figure 3 and Figure 4 In one embodiment, the first electrode 23, the electrostrictive film 25, the second electrode 24 and the supporting ring body 21 are arranged in sequence from the outside to the inside.

[0035] Preferably, in one embodiment, the hollow cannula 22, the first electrode 23, the electrostrictive film 25, and the second electrode 24 are connected together by bonding. The bonding material can be any adhesive material that results in a locking connection between the tubular member and the guidewire. The region between the hollow cannula 22, the first electrode 23, the electrostrictive film 25, and the second electrode 24 forms a solid matrix that prevents relative movement between them. Biocompatible materials are ideal, such as fibrin glue, methacrylates, or alginate, or other forms of "biological glue" or curable adhesives approved for use in the human body.

[0036] See also Figures 2 to 4 In one embodiment, the carotid artery embolic protection device 100 of the present invention further includes a first fixing member 5, which is fixedly connected between the push guidewire 1 and the hollow cannula 22. Specifically, the first fixing member 5 is sleeved onto the hollow cannula 22. More specifically, a connection hole 51 is defined within the first fixing member 5, and the guidewire assembly 3 passes through the push guidewire 1, the connection hole 51, and the hollow cannula 22 in sequence.

[0037] See also Figures 1 to 4In one embodiment, the support ring body 21 is made of a shape memory alloy, and the hollow sleeve 22 is made of an elastic polymer material. The support ring body 21 can be made of a shape memory alloy, such as nickel-titanium alloy or cobalt-chromium alloy, while the hollow sleeve 22 can be made of a polymer material, such as PEBAX or silicone.

[0038] In one embodiment, the electrostrictive film 25 may be a polyvinylidene fluoride compound, a piezoelectric crystal, or a piezoelectric ceramic; and the first electrode 23 and the second electrode 24 may be a composite material containing conductive polymers such as polyaniline and polypyrrole.

[0039] See also Figure 1 and Figure 2 In one embodiment, the filter screen 4 has an open end 41 and a closed end 42 , the open end 41 is connected to the hollow sleeve 22 , and the closed end 42 is connected to the push guide wire 1 .

[0040] See also Figure 1 and Figure 2 In one embodiment, the diameter of the filter 4 at the open end 41 is slightly larger than or equal to the diameter of the blood vessel 200. The open end 41 of the filter 4 obliquely cuts the longitudinal cross-section of the blood vessel, increasing the contact surface while ensuring that all forward blood flow passes through the open end 41 of the filter 4. Specifically, the pore size of the filter 4 is within the range of 50-150 microns. Preferably, the pore size of the filter 4 is within the range of 130-150 microns. This structure maximizes the ability of the filter 4 to capture and collect dislodged thrombi.

[0041] Specifically, the closed end 42 is fixed to the push guide wire 1 by the second fixing member 6. Furthermore, the second fixing member 6 is provided with a developing portion, which can be developed under X-ray irradiation conditions to indicate the position of the filter 4 in the blood vessel.

[0042] In one embodiment, the filter 4 is made of a polymer film material, specifically, the filter 4 can be made of a polymer material such as polycaprolactone or polypropylene, formed by melt-blowing or electrospinning and then punched with a laser or a machine.

[0043] In one embodiment, the filter screen 4 is bonded to the hollow sleeve 22 by glue.

[0044] In another embodiment, the filter screen 44 is woven from a self-expanding material. Specifically, the filter screen 4 is a self-expanding braided umbrella structure. The filter screen 4 covers at least the support ring assembly 2 along its circumference, and at least the proximal opening of the filter screen 4 contracts and expands to approximately the same degree as the support ring assembly 2.

[0045] The carotid artery embolism protection device 100 provided in this embodiment has good overall wall adhesion due to the radial tension of the support ring assembly 2, which can prevent thrombus from escaping from the gap between the anti-thrombotic protection device and the blood vessel wall, and at least the filter mesh 4 arranged around the distal end of the support ring assembly 2 can effectively capture thrombus and prevent thrombus from escaping to the distal end. Therefore, the carotid artery embolism protection device 100 provided by the present invention takes into account the requirements for wall adhesion and thrombus capture performance at the same time, which can effectively reduce the risk of thrombus escape.

[0046] The carotid embolism protection device 100 provided in this embodiment can fix the filter screen 4 to the distal end of the support ring assembly 2, for example, the distal end of the filter screen 4 is fixed to the connector located at the distal end of the support ring assembly 2, or the filter screen 4 can be directly fixed to the distal end of the support ring assembly 2, for example, by bundling, integral weaving, or the like.

[0047] The filter mesh 4 can be made of a variety of different materials, such as, but not limited to, woven or braided plastic or metal mesh, nitinol mesh, combinations thereof, or other materials capable of providing a mesh that captures substances in the flowing blood while allowing blood to flow through its pores. Generally, the filter mesh 4 can be made of a variety of materials, as long as the filter mesh 4 can be operably connected to at least some of the interconnecting elements and is biocompatible.

[0048] See also Figure 2 In one embodiment, the surfaces of the push guidewire 1 and the hollow cannula 22 are both provided with a hydrophilic coating, a low-friction coating, an anti-thrombotic coating, or a combination thereof. The hydrophilic coating and the low-friction coating facilitate navigation of the transcatheter device within the body during insertion and removal, thereby reducing friction during the push of the push guidewire 1 and minimizing damage to the blood vessel wall.

[0049] See also Figure 1 and Figure 2 In one embodiment, the carotid embolic protection device 100 of the present invention further includes a delivery catheter 7. When the carotid embolic protection device 100 is deployed, the guidewire 1, support ring assembly 2, and filter 4 are housed within the delivery catheter 7. The inner wall of the delivery catheter 7 compresses the support ring assembly 2, causing the support ring assembly 2 to deform and fold toward the guidewire 1. The delivery catheter 7 utilizes conventional delivery catheters, ensuring low cornering resistance and good maneuverability while also avoiding folding and providing sufficient support. This allows the delivery catheter to easily reach the target location, thereby delivering the carotid embolic protection device 100 to the desired location and improving the success rate and safety of interventional procedures.

[0050] Preferably, in one embodiment, the surface of the delivery tube 7 is provided with a hydrophilic coating.

[0051] Combine Figures 1 to 7The specific working principle of the carotid artery embolism protection device 100 of the present invention is as follows:

[0052] Initially, the push guidewire 1, support ring assembly 2, and filter 4 of the carotid embolic protection device 100 are housed within the delivery catheter 7. During interventional cerebral vascular surgery 200 or lower limb artery surgery, the operator pushes the entire delivery catheter 7 to the predetermined target location via the interventional sheath. The delivery catheter 7 is then withdrawn, releasing the support ring assembly 2 and filter 4 of the carotid embolic protection device 100. The support ring body 21, freed from its restraints, elastically expands, allowing the open end 41 of the filter 4 to adhere to the inner wall of the blood vessel 200. At this point, an external power source applies a specific electric field to the first and second electrodes 23 and 24 on either side of the electrostrictive membrane 25 through the first and second wires 31 and 32 of the wire assembly 3 within the push guidewire 1, causing the electrostrictive membrane 25 to expand and deform toward the blood vessel 200 wall, enhancing the adhesion of the open end 41 of the filter 4 to the wall. Thrombi 201 or plaque flowing downstream with the blood are effectively intercepted by the filter 4, preventing them from reaching other parts of the body. After the operation, the electric field is stopped or its direction is changed, causing the electrostrictive membrane 25 to contract and deform toward the center of the blood vessel 200, and the retrieval catheter is pushed to the target site, thereby storing the push guidewire 1, the support ring assembly 2, and the filter 4 inside the retrieval catheter, and then the carotid artery embolism protection device 100 of the present invention can be easily retrieved.

[0053] In summary, the carotid artery embolic protection device 100 of the present invention can apply a specific electric field to the electrostrictive component 26 through the guidewire assembly 3, causing the electrostrictive component 26 to expand toward the inner wall of the blood vessel 200, thereby changing the outer diameter of the support ring assembly 2, thereby enhancing the wall adhesion of the support ring assembly 2 and ensuring that the thrombus 201 does not escape from the gap between the support ring assembly 2 and the blood vessel 200 during surgery, thereby improving the safety of the surgery. After the surgery, the direction of the electric field applied to the electrostrictive component 26 by the guidewire assembly 3 can be changed to change the outer diameter of the support ring assembly 2, causing the electrostrictive component 26 to contract, thereby improving the convenience and efficiency of device recovery and reducing the risk of damage to the patient's blood vessel 200. Secondly, the surfaces of the delivery catheter 7, the push guidewire 1, and the hollow cannula 22 of the carotid artery embolic protection device 100 of the present invention are all provided with a hydrophilic coating, which can reduce friction between the device and the inner wall of the blood vessel 200 and provide better pushability.

[0054] The above disclosure is only a preferred embodiment of the present invention and cannot be used to limit the scope of the present invention. Therefore, equivalent changes made according to the claims of the present invention are within the scope of the present invention.

Claims

1. A carotid artery embolism protection device, characterized in that: include: A push guide wire is provided with a receiving cavity. A support ring assembly, the support ring assembly being fixed to the push guide wire, the support ring assembly comprising a support ring body, a hollow sleeve, and an electrostrictive assembly, the support ring body having a deformable structure, the hollow sleeve covering the support ring body and the electrostrictive assembly, the electrostrictive assembly being located outside the support ring body, and the outer diameter of the support ring assembly being changed by adjusting the electric field of the electrostrictive assembly; a wire assembly, the wire assembly being disposed in the accommodating cavity and passing through the push guide wire and the hollow cannula to be connected to the electrostrictive assembly; A filter screen is connected to the hollow sleeve.

2. The carotid artery embolic protection device according to claim 1, characterized in that: The electrostrictive component includes a first electrode, a second electrode and an electrostrictive film, wherein the first electrode and the second electrode are arranged on both sides of the electrostrictive film.

3. The carotid artery embolic protection device according to claim 2, characterized in that: The guide wire assembly includes a first guide wire and a second guide wire. The wire body of the first guide wire passes through the push guide wire and the hollow sleeve to be connected to the first electrode. The wire body of the second guide wire passes through the push guide wire and the hollow sleeve to be connected to the second electrode.

4. The carotid artery embolic protection device according to claim 2, characterized in that: The hollow sleeve, the first electrode, the electrostrictive film and the second electrode are connected together by bonding.

5. The carotid artery embolic protection device according to claim 1, characterized in that: It also includes a first fixing member, which is fixedly connected between the pushing guide wire and the hollow sleeve.

6. The carotid artery embolic protection device according to claim 5, characterized in that: A connecting hole is provided inside the first fixing member, and the guide wire assembly passes through the pushing guide wire, the connecting hole and the hollow sleeve in sequence.

7. The carotid artery embolic protection device according to claim 1, characterized in that: The supporting ring body is made of shape memory alloy, and the hollow sleeve is made of elastic polymer material.

8. The carotid artery embolic protection device according to claim 1, characterized in that: The filter screen has an open end and a closed end, the open end is connected to the hollow sleeve, and the closed end is connected to the push guide wire.

9. The carotid artery embolic protection device according to claim 1, characterized in that: The filter screen is made of a punched polymer membrane material or woven from a self-expanding material.

10. The carotid artery embolic protection device according to claim 1, characterized in that: The pore size of the filter screen is in the range of 50-150 microns.

11. The carotid artery embolic protection device according to claim 1, characterized in that: It also includes a delivery catheter. When pushing the carotid artery embolism protection device, the pushing guide wire, the support ring assembly and the filter screen are received inside the delivery catheter, and the inner wall of the delivery catheter squeezes the support ring assembly so that the support ring assembly is deformed and folded in the direction close to the pushing guide wire.

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