Carotid artery embolism protection device

Abstract

The invention provides a carotid artery embolism protection device which comprises a pushing guide wire, a supporting ring assembly, a wire assembly and a filter screen, a containing cavity is formed in the pushing guide wire, the supporting ring assembly is fixed to the pushing guide wire and comprises a supporting ring body, a hollow sleeve and an electrostriction assembly, the supporting ring body is of a deformable structure, and the hollow sleeve is fixed to the supporting ring body. The hollow sleeve wraps the supporting ring body and the electrostriction assembly, the electrostriction assembly is located on the outer side of the supporting ring body, and the outer diameter of the supporting ring assembly is changed by adjusting the electric field of the electrostriction assembly; the wire assembly is arranged in the containing cavity, and the wire assembly penetrates through the pushing guide wire and the hollow sleeve to be connected with the electrostriction assembly. And the filter screen is connected to the hollow sleeve. The wall attaching effect of the supporting ring assembly is enhanced, the operation safety is improved, and the device recycling convenience and the device recycling efficiency are improved.

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 may cause platelets in the blood to form aggregates of various forms, such as emboli, bacterial aggregates, and tiny tissue debris, or cause atherosclerotic plaque fragments and particles to fall off the arterial wall. Once these harmful components flow with the blood, they may invade the brain and other key arterial sites in the body, thereby inducing serious complications such as cerebrovascular obstruction and embolism of blood vessels below the knee.

[0003] In order to effectively prevent complications caused by embolic particles, advanced distal protection devices are often required during surgery. Their main function is to intercept plaque fragments flowing down the bloodstream, thereby cutting off the potential pathway for embolism. Currently, the common distal protection devices on the market mostly use distal filter system designs, such as Accunet (Abbott), Filterwire (Boston Scientific), etc. These products have been widely used in clinical practice.

[0004] Existing distal protection devices generally use shape memory metal as the supporting structure. This type of material has weak supporting force and is prone to form a gap between the opening end of the filter device and the blood vessel wall, causing some thrombi to escape to the distal blood vessels and cause postoperative complications. Chinese patent CN114271989A discloses a solution of fixing a water-absorbing and swellable material on the outside of the support ring to enhance the wall adhesion effect, but the water-absorbing material cannot shrink after expansion, which may bring certain difficulties to the recovery of 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 which can enhance the wall adhesion effect and improve the device recovery efficiency.

[0007] To achieve the above-mentioned object, the present invention provides a carotid artery embolism protection device, comprising a push guide wire, a support ring assembly, a wire assembly and a filter screen, wherein the push guide wire is provided with a housing cavity, the support ring assembly is fixed on the push guide wire, the support ring assembly comprises a support ring body, a hollow sleeve and an electrostrictive assembly, the support ring body has a deformable structure, the hollow sleeve covers the support ring body and the electrostrictive assembly, the electrostrictive assembly is located on the outside of the support ring body, and the outer diameter of the support ring assembly is changed by adjusting the electric field of the electrostrictive assembly; the wire assembly is arranged in the housing cavity, and the wire assembly passes through the push guide wire and the hollow sleeve and is connected to the electrostrictive assembly; the filter screen is connected to the hollow sleeve.

[0008] Preferably, the electrostrictive component comprises 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 sleeve 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 sleeve 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 comprises a first fixing member, wherein the first fixing member is fixedly connected between the push guide wire and the hollow sleeve.

[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 perforated 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 net are received inside the delivery catheter, and the inner wall of the delivery catheter squeezes the support ring assembly so that the support assembly is deformed and folded in a direction close to the pushing guide wire.

[0018] Compared with the prior art, the carotid artery embolism protection device of the present invention is provided with a guide wire assembly in the accommodating cavity of the push guide wire. At the same time, the support ring assembly is provided with a hollow sleeve, a support ring body and an electrostrictive assembly, and the guide wire assembly is connected to the electrostrictive assembly. Therefore, a specific electric field can be applied to the electrostrictive assembly through the guide wire assembly, so that the electrostrictive assembly expands toward the inner wall of the blood vessel and abuts against the hollow sleeve, so as to change the outer diameter of the support ring assembly, so that the outer diameter of the support ring assembly becomes larger and fits on the inner wall of the blood vessel, thereby enhancing the wall adhesion effect of the support ring assembly, ensuring that the thrombus will not escape from the gap between the support ring assembly and the blood vessel during the operation, thereby improving the safety of the operation; after the operation, the direction of the electric field applied by the guide wire assembly to the electrostrictive assembly can be changed to change the outer diameter of the electrostrictive assembly, so that the electrostrictive assembly shrinks, thereby improving the convenience and efficiency of device recovery and reducing 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 a push guide wire, a support ring assembly and a filter screen are accommodated in a 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 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 It 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 It 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 It 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 when energized. DETAILED DESCRIPTION

[0026] In order to explain the technical content and structural features of the present invention in detail, further description will be given below in combination with the implementation modes and the accompanying drawings.

[0027] See also Figures 1 to 7 The carotid artery embolism protection device 100 of the present invention includes a push guide wire 1, a support ring assembly 2, a wire assembly 3 and a filter 4. The push guide wire 1 is provided with a receiving cavity 11. The support ring assembly 2 is fixed on the push guide wire 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. By adjusting the electric field of the electrostrictive assembly 26, the outer diameter of the electrostrictive assembly 26 can be changed; the wire assembly 3 is arranged in the receiving cavity 11, and the wire assembly 3 passes through the push guide wire 1 and the hollow sleeve 22 and is connected to the electrostrictive assembly 26; the filter 4 is connected to the hollow sleeve 22.

[0028] The carotid artery embolism protection device 100 of the present invention is provided with a guide wire assembly 3 in the accommodating cavity 11 of the push guide wire 1. At the same time, the support ring assembly 2 is provided with a hollow sleeve 22, a support ring body 21 and an electrostrictive assembly 26, and the guide wire assembly 3 is connected to the electrostrictive assembly 26. Therefore, a specific electric field can be applied to the electrostrictive assembly 26 through the guide wire assembly 3, so that the electrostrictive assembly 26 expands toward the inner wall of the blood vessel 200 and abuts against the hollow sleeve 22, so as to change the outer diameter of the support ring assembly 2, so that the outer diameter of the support ring assembly 2 becomes larger and fits on the inner wall of the blood vessel 200, thereby enhancing the wall adhesion effect of the support ring assembly 2, ensuring that the thrombus 201 will not escape from the gap between the support ring assembly 2 and the blood vessel 200 during the operation, thereby improving the safety of the operation. 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, so that the support ring assembly 2 shrinks, 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 changing the outer diameter of the support ring assembly 2 by adjusting the electric field of the electrostrictive assembly 26 is as follows: the electric field is increased, and the electrostrictive assembly 26 expands. Within a certain range, the greater the electric field increases, the greater the expansion of the electrostrictive assembly 26, thereby causing the outer diameter of the support ring assembly 2 to expand more; the size of the applied electric field can be determined according to the distance between the support ring assembly 2 and the inner wall of the blood vessel 200. Similarly, after changing the direction of the electric field, the electric field is increased, and the electrostrictive assembly 26 contracts. Within a certain range, the greater the electric field increases, the greater the contraction of the electrostrictive assembly 26, thereby causing the outer diameter of the support ring assembly 2 to contract less, and at this time, it is convenient to be stored in the recovery 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 component 26 includes a first electrode 23 , a second electrode 24 and an electrostrictive film 25 , and 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 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 sleeve 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 bonding material that causes locking between the tubular member and the guide wire. The area between the hollow sleeve 22, the first electrode 23, the electrostrictive film 25, and the second electrode 24 forms a solid matrix that cannot move relative to each other. Biocompatible materials are ideal, such as fibrin glue, methacrylate 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 embolism protection device 100 of the present invention further includes a first fixing member 5, which is fixedly connected between the push guide wire 1 and the hollow sleeve 22. Specifically, the first fixing member 5 is sleeved on the hollow sleeve 22. More specifically, a connecting hole 51 is provided inside the first fixing member 5, and the guide wire assembly 3 passes through the push guide wire 1, the connecting hole 51 and the hollow sleeve 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, cobalt-chromium alloy, etc.; the hollow sleeve 22 can be made of a polymer material such as PEBAX, silicone, etc.

[0038] In one embodiment, the electrostrictive film 25 may be a polyvinylidene fluoride compound, a piezoelectric crystal or a piezoelectric ceramic; 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 opening end 41 is slightly larger than or equal to the diameter of the blood vessel 200, and the opening end 41 of the filter 4 is an oblique cut of the longitudinal section of the blood vessel, which not only increases the contact surface, but also ensures that all forward blood flows pass through the opening end 41 of the filter 4. Specifically, the filter pore size of the filter 4 is in the range of 50-150 microns. Preferably, the filter pore size of the filter 4 is in the range of 130-150 microns. This structure can maximize the capture and collection of detached thrombi by the filter 4.

[0041] Specifically, the closed end 42 is fixed to the push guide wire 1 through the second fixing member 6. Further, the second fixing member 6 is provided with a developing part, and under the X-ray irradiation condition, the developing part of the second fixing member 6 can be developed, thereby indicating the position of the filter 4 in the blood vessel.

[0042] In one embodiment, the filter screen 4 is made of a polymer film material, for example, polycaprolactone, polypropylene or other polymer materials, which are formed by melt-blowing or electrostatic spinning 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 net 44 is woven from a self-expanding material. Specifically, the filter net 4 is a self-expanding woven umbrella structure. The filter net 4 at least covers the support ring assembly 2 along the circumference of the support ring assembly 2, and at least the degree of folding and opening of the proximal opening of the filter net 4 is nearly consistent with that of the support ring assembly 2.

[0045] The carotid embolism protection device 100 provided in this embodiment has good overall wall adhesion through the radial tension of the support ring assembly 2, which can prevent the thrombus from escaping from the gap between the anti-thrombus protection device and the blood vessel wall, and at least the filter net 4 arranged around the distal end of the support ring assembly 2 can effectively capture the thrombus and prevent the thrombus from escaping to the distal end. Therefore, the carotid 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 net 4 to the distal end of the support ring assembly 2. For example, the distal end of the filter net 4 is fixed to a connector located at the distal end of the support ring assembly 2. Alternatively, the filter net 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. In general, 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 guide wire 1 and the hollow sleeve 22 are provided with a hydrophilic coating, a low friction coating or an anti-thrombotic coating or a combination thereof. The hydrophilic coating and the low friction coating facilitate navigation of the transcatheter device in the body during insertion and removal, thereby reducing the pushing friction of the push guide wire 1 and reducing 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 pushed, the push guide wire 1, the support ring assembly 2 and the filter screen 4 are stored in the delivery catheter 7, and the inner wall of the delivery catheter 7 squeezes the support ring assembly 2, so that the support assembly is deformed and folded in the direction close to the push guide wire 1. The delivery catheter 7 adopts the delivery catheter of the prior art, which can ensure small bending resistance and good passability, and can avoid folding and have sufficient support. The delivery catheter can reach the target position relatively easily, and then the carotid embolic protection device 100 is delivered to the right place, thereby improving the success rate and safety of the interventional surgery.

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

[0051] Combination 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 guide wire 1, the support ring assembly 2 and the filter 4 of the carotid artery embolism protection device 100 are stored inside the delivery catheter 7. When performing interventional cerebrovascular 200 and lower limb artery surgery, the operator pushes the entire delivery catheter 7 to the predetermined target position through the intervention sheath, then withdraws the delivery catheter 7, releases the support ring assembly 2 and the filter 4 of the carotid artery embolism protection device 100 of the present invention, and the support ring body 21 will be elastically unfolded due to being freed from the constraint, so that the open end 41 of the filter 4 is attached to the inner wall of the blood vessel 200. At this time, an external power source is used to apply a specific electric field to the first electrode 23 and the second electrode 24 on both sides of the electrostrictive film 25 through the first wire 31 and the second wire 32 of the wire assembly 3 in the push guide wire 1, so that the electrostrictive film 25 expands and deforms toward the wall of the blood vessel 200, thereby enhancing the wall-attaching effect of the open end 41 of the filter 4. The thrombus 201 or plaque flowing downstream with the blood will be effectively intercepted by the filter 4 and cannot flow to other parts of the body. After the operation, the electric field is stopped or the direction of the applied electric field is changed, so that the electrostrictive membrane 25 contracts and deforms toward the center of the blood vessel 200, and the recovery catheter is pushed to the target site, so that the push guide wire 1, the support ring assembly 2 and the filter screen 4 are stored in the recovery catheter, and the carotid artery embolism protection device 100 of the present invention can be easily recovered.

[0053] In summary, the carotid artery embolism protection device 100 of the present invention can apply a specific electric field to the electrostrictive component 26 through the wire assembly 3, so that the electrostrictive component 26 expands toward the inner wall of the blood vessel 200 to change the outer diameter of the support ring assembly 2, thereby enhancing the wall adhesion effect of the support ring assembly 2, ensuring that the thrombus 201 will not escape from the gap between the support ring assembly 2 and the blood vessel 200 during the operation, thereby improving the safety of the operation; after the operation, the direction of the electric field applied by the wire assembly 3 to the electrostrictive component 26 can be changed to change the outer diameter of the support ring assembly 2, so that the electrostrictive component 26 shrinks, 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 guide wire 1 and the hollow sleeve 22 of the carotid artery embolism protection device 100 of the present invention are all provided with a hydrophilic coating, which can reduce the friction between the device and the inner wall of the blood vessel 200 and has good pushability.

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

Claims

1. A carotid artery embolism protection device, characterized in that: include: A push guide wire, wherein a receiving cavity is provided in the push guide wire, A support ring assembly, the support ring assembly is fixed on the push guide wire, the support ring assembly comprises a support ring body, a hollow sleeve and an electrostrictive assembly, the support ring body has a deformable structure, the hollow sleeve covers the support ring body and the electrostrictive assembly, the electrostrictive assembly is located outside the support ring body, and the outer diameter of the support ring assembly is changed by adjusting the electric field of the electrostrictive assembly; A wire assembly, the wire assembly is disposed in the accommodating cavity, and the wire assembly passes through the push guide wire and the hollow sleeve 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 push 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 high molecular membrane material with holes punched in it or is 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 the carotid artery embolism protection device is pushed, the pushing guide wire, the support ring assembly and the filter net are received inside the delivery catheter, and the inner wall of the delivery catheter squeezes the support ring assembly so that the support assembly is deformed and folded in a direction close to the pushing guide wire.

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