Intravascular embolic protection device

Abstract

The present invention discloses an intravascular embolism protection device, which includes a delivery guidewire, a first filter and a second filter, wherein the first filter is located at the proximal portion of the second filter; the first filter and the second filter are spaced apart at the distal portion of the delivery guidewire to intercept foreign tissues in the blood vessel and allow blood to pass through, the first filter includes a plurality of flexible brushes, and the plurality of brushes are radially arranged on the outer peripheral wall of the delivery guidewire, and the second filter includes a mesh filter. Based on the above-mentioned intravascular embolism protection device, two far and near filtration channels for filtering foreign tissues such as thrombi are configured, which can effectively reduce the risk of thrombus escape, and can block thrombi in the longer area between the first filter and the second filter, thereby preventing thrombi from accumulating in one place and causing blood flow obstruction.

Description

Technical Field

[0001] The present invention relates to the technical field of interventional medical equipment, and in particular to an intravascular embolism protection device. Background Art

[0002] During interventional cerebrovascular and lower limb arterial surgeries, surgical instruments can induce platelets in the blood to aggregate into various forms, including emboli, bacterial clumps, and tiny tissue fragments, or detach atherosclerotic plaque fragments and particles from the arterial wall. These substances circulate in the blood and can invade the brain and other critical arterial regions of the body, causing complications such as cerebral vascular embolism and below-the-knee vascular embolism.

[0003] To effectively prevent complications caused by embolic particles, distal protection devices are often used during surgery. These devices capture plaque fragments flowing downstream in the blood vessels and block the path of embolism. Currently, distal protection devices on the market primarily utilize distal filter systems, such as the widely used Accunet device (Abbott), the Angioguard device (Cordis), and the Filterwire device (Boston Scientific).

[0004] However, existing products generally adopt a single-layer filter design. When the number of blood clots is too large or the volume is too large, the blood clots will accumulate in the filter and easily cause blood vessel blockage. Summary of the Invention

[0005] The purpose of the present invention is to provide an intravascular embolism protection device that can effectively prevent thrombus accumulation and blockage.

[0006] In order to achieve the above-mentioned object, the present invention provides an intravascular embolic protection device, which includes a delivery guide wire, a first filter and a second filter, wherein the first filter is located at a proximal end portion of the second filter;

[0007] The first filter and the second filter are arranged at the distal end of the delivery guide wire to intercept foreign tissue in the blood vessel and allow blood to pass through. The first filter includes a plurality of flexible brushes, which are radially arranged on the outer wall of the delivery guide wire. The second filter includes a mesh filter.

[0008] Preferably, a delivery catheter is further included, wherein the delivery guide wire is passed through the delivery catheter, and the delivery catheter can slide along the delivery guide wire to collect the first filter and the second filter in the delivery catheter or release them into the blood vessel.

[0009] Preferably, when the delivery catheter releases the first filter and the second filter into a blood vessel, the open end of the filter mesh and the end of the brush facing away from the delivery guide wire abut against the inner wall of the blood vessel.

[0010] Preferably, the outer peripheral wall of the distal end of the delivery catheter is coated with a hydrophilic coating.

[0011] Preferably, the first filter further comprises a sleeve sleeved on the outer peripheral wall of the delivery guide wire, one end of the brush is fixed on the sleeve, the other end of the brush extends outward from the sleeve, and the sleeve is fixedly connected to the delivery guide wire.

[0012] Preferably, the second filter further comprises a plurality of support rods, each of the support rods comprising a first fixed end and a movable end; the first fixed ends of the plurality of support rods are centrally connected to the delivery guide wire, and the movable ends of the plurality of support rods are radially extended in a circumferential direction; the movable ends can be elastically retracted under the action of a restraining force;

[0013] The filter screen is a bag-like structure, including a second fixed end and an open end. The filter screen is connected to the delivery guide wire through the second fixed end, and the open end is connected to the movable ends of several support rods; the first fixed end is located at the proximal end of the second fixed end.

[0014] Preferably, a developing member is provided at one end and / or both ends of the first filter and the second filter respectively.

[0015] Preferably, the second filter further comprises a first sliding ring, a second sliding ring, a first limiting ring and a second limiting ring which are sleeved on the delivery guide wire; the first sliding ring is located at the proximal end of the second sliding ring, the first limiting ring is located between the first sliding ring and the second sliding ring, and the second limiting ring is located at the distal end of the second sliding ring; the first sliding ring and the second sliding ring can slide relative to the delivery guide wire, the first limiting ring and the second limiting ring are fixed on the delivery guide wire, and the outer diameters of the first limiting ring and the second limiting ring are larger than the inner diameter of the second sliding ring;

[0016] The first fixed end is connected to the first sliding ring, and the second fixed end is connected to the second sliding ring.

[0017] Preferably, after the filter screen is unfolded, the diameter of the filter screen gradually decreases from the opening end to the second fixed end, so that the filter screen has a cone-shaped structure as a whole.

[0018] Preferably, the filter screen includes a first section and a second section, the second fixed end is located in the first section, and the open end is located in the second section. After the filter screen is unfolded, the diameter of the first section gradually increases from the second fixed end toward the second section, so that the first section has a conical structure as a whole, and the diameter of the second section along the axial direction is the same, so that the second section has a cylindrical structure as a whole.

[0019] Preferably, the filter screen is provided with a plurality of through holes, and the aperture of the through holes is between 70 and 130 microns.

[0020] Compared with the prior art, the intravascular embolism protection device disclosed in the above technical solution of the present invention is equipped with two filtering channels, one for filtering thrombus and other foreign tissues, namely a first filter based on a brush and a second filter based on a filter mesh, and the first filter is located at the proximal end of the second filter. Therefore, when the amount of thrombus is relatively large, part of the thrombus is blocked at the first filter, and part of the thrombus enters the second filter through the brush, thereby effectively reducing the risk of thrombus escape. Moreover, the thrombus can be blocked in the longer area between the first filter and the second filter to avoid the accumulation of thrombus in one place and causing blood flow obstruction. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 FIG1 is a planar structural diagram of an embolic protection device in use according to one embodiment of the present invention.

[0022] Figure 2 for Figure 1 A planar structural diagram of the embolic protection device in the folded state.

[0023] Figure 3 for Figure 1 Three-dimensional structure diagram of the middle filter.

[0024] Figure 4 FIG1 is a planar structural diagram of an embolic protection device in use according to another embodiment of the present invention.

[0025] Figure 5 for Figure 4 A planar structural diagram of the embolic protection device in the folded state.

[0026] Figure 6 for Figure 4 Three-dimensional structure diagram of the middle filter. DETAILED DESCRIPTION

[0027] In order to explain the technical content, structural features, achieved objectives and effects of the present invention in detail, the following is a detailed description in conjunction with the embodiments and the accompanying drawings.

[0028] like Figure 1This embodiment discloses an intravascular embolism protection device for use in interventional cerebrovascular and lower limb arterial surgery to prevent thrombus S and other foreign tissues that fall off from blood vessel G from circulating in the blood during the operation.

[0029] First, it should be noted that the term "distal end" in this embodiment and the following embodiments refers to the end close to the target position, and the "proximal end" refers to the end close to the surgical operator.

[0030] The protection device includes a delivery guide wire 3 , a first filter 1 and a second filter 2 , wherein the first filter 1 is located at the proximal end of the second filter 2 .

[0031] The first filter 1 and the second filter 2 are spaced apart at the distal end of the delivery guide wire 3 to intercept foreign tissue in the blood vessel G and allow blood to pass through. The first filter 1 includes a plurality of flexible brushes 10, which are radially arranged on the outer wall of the delivery guide wire 3. The second filter 2 includes a mesh filter 20.

[0032] During use, the first filter 1 and the second filter 2 can be placed distally to the target location. Foreign matter, such as thrombi S, generated during treatment is first intercepted by the brushes 10 of the first filter 1, with blood flowing through the gaps between the brushes 10. When the amount of thrombi S is relatively large, some, propelled by the blood flow, can break through the interception of the brushes 10 and reach the second filter 2, where they are then intercepted by the filter screen 20 of the second filter 2, while blood flows through the filter screen 20. Thus, the protective device effectively reduces the risk of thrombi S escaping. Furthermore, thrombi S are trapped in the long area between the first filter 1 and the second filter 2, preventing them from accumulating in one place and obstructing blood flow.

[0033] On the other hand, Figure 2 The protection device also includes a delivery catheter 4, in which the delivery guide wire 3 is passed, and the delivery catheter 4 can slide along the delivery guide wire 3 to converge the first filter 1 and the second filter 2 in the delivery catheter 4 or release them into the blood vessel G.

[0034] In this embodiment, the first filter 1 and the second filter 2 can be pushed to the target location within the blood vessel G via the delivery catheter 4. During the pushing process, the first filter 1 and the second filter 2 are confined within the delivery catheter 4, preventing the first filter 1 and the second filter 2 from damaging the inner wall of the blood vessel G during movement. After the first filter 1 and the second filter 2 are pushed to the target location, the delivery catheter 4 is withdrawn, releasing the first filter 1 and the second filter 2 into the blood vessel G in a protected state.

[0035] Further, when the delivery catheter 4 releases the first filter 1 and the second filter 2 into the blood vessel G, as shown in FIG. Figure 1The open end 201 of the filter 20 and the end of the brush 10 facing away from the delivery guide wire 3 abut against the inner wall of the blood vessel G to prevent the thrombus S from escaping.

[0036] In addition, in order to allow the delivery catheter 4 to move smoothly in the blood vessel G and reduce damage to the inner wall of the blood vessel G during the movement of the delivery catheter 4, the outer peripheral wall of the distal end of the delivery catheter 4 is coated with a hydrophilic coating (not shown).

[0037] On the other hand, the first filter 1 also includes a sleeve 11 that is sleeved onto the outer wall of the delivery guidewire 3. One end of the brush 10 is fixed to the sleeve 11, and the other end of the brush 10 extends outward from the sleeve 11. The sleeve 11 is fixedly connected to the delivery guidewire 3. The provision of the sleeve 11 facilitates the fixation of the brush 10 to the delivery guidewire 3. Specifically, a set of fastening rings 6 provided on the delivery guidewire are provided at each end of the sleeve 11 to secure the sleeve 11.

[0038] Second filter 2 also includes a plurality of rods 21, each comprising a first fixed end 210 and a movable end 211. The first fixed ends 210 of the rods 21 are centrally connected to the delivery guidewire 3, while the movable ends 211 of the rods 21 extend radially in a circumferential direction. The movable ends 211 can be elastically retracted under the restraining force of the delivery catheter 4.

[0039] The filter screen 20 has a bag-like structure and includes a second fixed end 200 and an open end 201. The filter screen 20 is connected to the delivery guide wire 3 via the second fixed end 200. The open end 201 is connected to the movable ends 211 of the plurality of support rods 21, so that the movable ends 211 of the plurality of support rods 21 drive the opening and closing of the open end 201 of the filter screen 20. The first fixed end 210 is located proximal to the second fixed end 200.

[0040] Specifically, the support rod 21 in this embodiment is preferably made of a shape memory alloy, such as nickel-titanium alloy, cobalt-chromium alloy, etc., and the filter screen 20 can be made of a polymer material such as polycaprolactone, polypropylene, etc.

[0041] The brush 10 can be made of a polymer material such as polyethylene, polypropylene, etc. The brush 10 is bonded to the outer surface of the hollow sleeve 11 by glue.

[0042] like Figure 3 The filter screen 20 is provided with a plurality of through holes 202, and the aperture of the through holes 202 is between 70 and 130 microns, preferably between 80 and 110 microns.

[0043] On the other hand, a developing member 5 is provided at one end and / or both ends of the first filter 1 and the second filter 2 , respectively, so as to monitor the positions of the first filter 1 and the second filter 2 in the blood vessel G.

[0044] On the other hand, Figure 4 and Figure 5 The second filter 2 further includes a first sliding ring 70 , a second sliding ring 71 , a first limiting ring 80 and a second limiting ring 81 which are sleeved on the delivery guide wire 3 .

[0045] The first sliding ring 70 is located proximal to the second sliding ring 71, the first limiting ring 80 is located between the first sliding ring 70 and the second sliding ring 71, and the second limiting ring 81 is located distal to the second sliding ring 71. The first sliding ring 70 and the second sliding ring 71 can slide relative to the delivery guide wire 3. The first limiting ring 80 and the second limiting ring 81 are fixed to the delivery guide wire 3, and the outer diameters of the first limiting ring 80 and the second limiting ring are larger than the inner diameter of the second sliding ring 71.

[0046] The first fixed end 210 is connected to the first sliding ring 70 , and the second fixed end 200 is connected to the second sliding ring 71 .

[0047] In this embodiment, the first sliding ring 70 and the second sliding ring 71 are arranged so that the delivery guidewire 3 can slide relative to the second filter 2, and the maximum distance of relative sliding is the distance between the first limiting ring 80 and the second limiting ring 81. In this way, during the process of pushing to the target position, the first limiting ring 80 abuts against the second sliding ring 71, and the delivery guidewire 3 pushes the second sliding ring 71 to move distally, that is, the delivery guidewire 3 drives the second filter 2 to move distally. After the treatment is completed, when the delivery guidewire 3 is withdrawn, the second limiting ring 81 abuts against the second sliding ring 71, and the delivery guidewire 3 pulls the second sliding ring 71 to move proximally, that is, the delivery guidewire 3 drives the second filter 2 to move proximally.

[0048] Additionally, during treatment, the guidewire 3 can be gently pushed distally, with the distance less than the distance between the first limiting ring 80 and the second sliding ring 71. This causes the guidewire 3 to move the brush 10, which simultaneously slides within the first and second sliding rings 70 and 71. The second filter 2 abuts against the vessel wall, keeping the second filter 2 stationary. The movement of the brush 10 then removes any thrombus S adhering to the inner wall of the vessel G, preventing residual thrombus S from causing postoperative complications.

[0049] Furthermore, during treatment, the delivery guidewire 3 can be gently rotated, which in turn rotates the brush 10. Since the second sliding ring 71 is slidably connected to the delivery guidewire 3, the second filter 2 abuts against the vessel wall, keeping the second filter 2 stationary. The movement of the brush 10 then removes any thrombus S adhering to the inner wall of the vessel G, preventing residual thrombus S from causing postoperative complications.

[0050] On the other hand, Figures 1 to 3After the filter screen 20 is unfolded, the diameter of the filter screen 20 gradually decreases from the opening end 201 to the second fixed end 200, so that the filter screen 20 has a cone-shaped structure as a whole.

[0051] On the other hand, if Figures 4 to 6 The filter screen 20 includes a first section D1 and a second section D2. The second fixed end 200 is located in the first section D1, and the open end 201 is located in the second section D2. When the filter screen 20 is deployed, the diameter of the first section D1 gradually increases from the second fixed end 200 toward the second section D2, resulting in an overall conical structure for the first section D1. The diameter of the second section D2 remains constant along the axial direction, resulting in an overall cylindrical structure for the second section D2. In this embodiment, the filter screen 20 is divided into two sections, one conical and one cylindrical. The provision of the cylindrical second section D2 effectively increases the contact area between the filter screen 20 and the inner wall of the blood vessel G, improving the filter screen 20's adherence to the wall and reducing the escape rate of thrombi S through the filter screen 20.

[0052] In summary, the present invention discloses an intravascular embolic protection device with a double-layer filtering effect. When performing interventional cerebrovascular and lower limb arterial surgery, the surgeon pushes the entire delivery catheter 4 along the delivery guidewire 3 to a predetermined target location via an interventional sheath. The delivery catheter 4 is then withdrawn, releasing the second filter 2 and the first filter 1 in sequence. The struts 21 of the second filter 2 then elastically expand, allowing the open end 201 of the filter 20 to fit tightly against the inner wall of the blood vessel G. The brush 10 automatically expands after losing the restraining force of the delivery catheter 4. The diameter of the brush 10 is comparable to the inner diameter of the blood vessel G, ensuring full contact between the brush 10 and the thrombus S. When the number of thrombi S is excessive or the volume is too large, some thrombi S will be intercepted by the brush 10, while others will flow downstream through the gaps between the brush 10 and be captured by the filter 20. During the procedure, the delivery guidewire 3 can be gently pushed distally, causing the brush 10 to move within the blood vessel G to remove thrombi S adhered to the inner wall of the blood vessel G.

[0053] After the operation is completed, the delivery catheter 4 is pushed to the target site, and the first filter 1 and the second filter 2 are retrieved in turn. During the process, the brush 10 is squeezed by the mouth of the delivery catheter 4, and the thrombus S on it may fall off, but it can still be captured again by the filter net 20 at the distal end.

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

Claims

1. An intravascular embolism protection device, characterized in that: It includes a delivery guide wire, a first filter and a second filter, wherein the first filter is located at the proximal end of the second filter; The first filter and the second filter are arranged at a distance from each other at the distal end of the delivery guidewire to intercept foreign tissue in the blood vessel and allow blood to pass through. The first filter includes a plurality of flexible brushes, and the brushes are radially arranged on the outer peripheral wall of the delivery guidewire. The second filter includes a mesh filter. The second filter also includes a plurality of support rods, each of which includes a first fixed end and a movable end. The first fixed ends of the plurality of support rods are centrally connected to the delivery guidewire, and the movable ends of the plurality of support rods are radially extended in a circumferential direction. The movable ends can be elastically retracted under the action of a restraining force. The filter screen is in a bag-like structure, comprising a second fixed end and an open end, wherein the filter screen is connected to the delivery guide wire via the second fixed end, and the open end is connected to the movable ends of the plurality of support rods; the first fixed end is located proximal to the second fixed end; The second filter further includes a first sliding ring, a second sliding ring, a first limiting ring and a second limiting ring which are sleeved on the delivery guide wire; the first sliding ring is located at the proximal end of the second sliding ring, the first limiting ring is located between the first sliding ring and the second sliding ring, and the second limiting ring is located at the distal end of the second sliding ring; the first sliding ring and the second sliding ring can slide relative to the delivery guide wire, the first limiting ring and the second limiting ring are fixed on the delivery guide wire, and the outer diameters of the first limiting ring and the second limiting ring are larger than the inner diameter of the second sliding ring; The first fixed end is connected to the first sliding ring, and the second fixed end is connected to the second sliding ring.

2. The intravascular embolic protection device according to claim 1, characterized in that: The invention also includes a delivery catheter, wherein the delivery guide wire is passed through the delivery catheter, and the delivery catheter can slide along the delivery guide wire to collect the first filter and the second filter in the delivery catheter or release them into the blood vessel.

3. The intravascular embolic protection device according to claim 2, characterized in that: When the delivery catheter releases the first filter and the second filter into a blood vessel, the open end of the filter mesh and the end of the brush facing away from the delivery guide wire abut against the inner wall of the blood vessel.

4. The intravascular embolic protection device according to claim 1, characterized in that: The first filter further comprises a sleeve sleeved on the outer peripheral wall of the delivery guide wire, one end of the brush is fixed on the sleeve, the other end of the brush extends outward from the sleeve, and the sleeve is fixedly connected to the delivery guide wire.

5. The intravascular embolic protection device according to claim 1, characterized in that: One end and / or both ends of the first filter and the second filter are respectively provided with a developing member.

6. The intravascular embolic protection device according to claim 1, characterized in that: After the filter screen is unfolded, the diameter of the filter screen gradually decreases from the opening end to the second fixed end, so that the filter screen has a cone-shaped structure as a whole.

7. The intravascular embolic protection device according to claim 1, characterized in that: The filter screen includes a first section and a second section, the second fixed end is located in the first section, and the open end is located in the second section. After the filter screen is unfolded, the diameter of the first section gradually increases from the second fixed end toward the second section, so that the first section has a conical structure as a whole, and the diameter of the second section along the axial direction is the same, so that the second section has a cylindrical structure as a whole.

8. The intravascular embolic protection device according to claim 1, characterized in that: The filter screen is provided with a plurality of through holes, and the aperture of the through holes is between 70 and 130 microns.

Images