Intracranial embolism protection device

Abstract

The invention provides an intracranial embolism protection device, and belongs to the technical field of interventional operation medical instruments. The intracranial embolism protection device comprises a balloon guide wire, a filling valve body and a conveying catheter, an intercepting filter screen capable of automatically expanding is arranged at the far end of the balloon guide wire, a balloon body is arranged at the opening position of the near end of the intercepting filter screen, the balloon guide wire is provided with a filling section and a bare wire section located at the far end of the filling section, and the filling section is provided with a guide wire body. A protective layer is arranged on the outer side of the guide wire body, a filling channel extending in the axial direction is formed between the guide wire body and the protective layer, a balloon body is arranged at the far end of the protective layer, and the balloon body is communicated with the filling channel; the filling valve body is detachably arranged at the near end of the guide wire body and is used for being connected with filling equipment to charge and discharge the balloon body; the conveying catheter is used for conveying the balloon guide wire to the far end of the lesion narrow position; the technical problems that in the prior art, a far-end filter screen has the edge leakage risk, and emboli cannot be completely intercepted are mainly solved.

Description

Technical Field

[0001] This invention belongs to the field of interventional surgical medical device technology, specifically relating to an intracranial embolism protection device. Background Technology

[0002] Intracranial embolization protection devices are key instruments used in neurointerventional surgery. Their core objective is to capture or block emboli (thrombi, plaque fragments, etc.) that may detach from the lesion site during the procedure, preventing these emboli from traveling with the bloodstream to distal intracranial vessels, thereby significantly reducing the risk of ischemic stroke during interventional surgery. The working principle of intracranial embolization protection devices is mainly based on establishing a physical barrier or changing the direction of blood flow between the lesion (stenosis) and the brain to intercept or capture detached emboli.

[0003] The most common type of intracranial embolism protection device is the distal filter. The distal filter works by delivering a foldable filter via a guidewire to the normal segment of the internal carotid artery distal to the stenosis. The filter is then released and opened, allowing blood flow but intercepting emboli. Normal surgical procedures are then performed to treat the emboli at the stenosis. During this process, small emboli may enter the filter with the bloodstream and be intercepted. After the procedure, the distal filter is retracted and removed from the body.

[0004] However, the aforementioned embolism protection device has the following problem: after the distal filter expands inside the blood vessel, the opening edge may not be able to completely adhere to the wall, causing emboli to leak from the edge of the filter, especially when the blood vessel diameter is too large, conical, or irregular in shape, the risk is even higher.

[0005] Therefore, there is a need to provide an improved technical solution that addresses the shortcomings of the existing technology. Summary of the Invention

[0006] The purpose of this invention is to provide an intracranial embolism protection device to solve the technical problem in the prior art where the distal filter has the risk of edge leakage and is difficult to completely intercept emboli.

[0007] To achieve the above objectives, the intracranial embolism protection device of the present invention provides the following technical solution:

[0008] An intracranial embolism protection device, comprising:

[0009] A balloon guidewire, wherein the distal end of the balloon guidewire is provided with an automatically inflatable intercepting filter, and a balloon body is provided at the proximal opening of the intercepting filter. The balloon guidewire has an inflatable section and a bare wire section located at the distal end of the inflatable section. The inflatable section has a guidewire body, and the outer side of the guidewire body has a protective layer. An axially extending inflatable channel is formed between the guidewire body and the protective layer. The distal end of the protective layer has a balloon body, and the balloon body communicates with the inflatable channel.

[0010] An inflation valve body is detachably disposed near the end of the guidewire body for connecting an inflation device to inflate or deflate a balloon.

[0011] A delivery catheter for delivering a balloon guidewire to the distal end of the lesion stenosis;

[0012] One part of the balloon is arranged inside the interceptor filter, and the other part extends from the proximal end of the interceptor filter to fully support the interceptor filter during radial expansion, so that the interceptor filter adheres tightly to the inner wall of the blood vessel.

[0013] As a further optimized technical solution, the intercepting filter includes a filter body, and a retraction unit is coaxially arranged at the near end of the filter body for retracting the filter body when it is withdrawn.

[0014] As a further optimized technical solution, the recovery unit includes a fixing block and a pull wire. The fixing block is set on the balloon guide wire, and there are multiple pull wires. One end of each pull wire is fixedly connected to the fixing block, and the other end is fixedly connected to the interception filter.

[0015] As a further optimized technical solution, the drawing wires are arranged at uniform intervals along the circumference of the filter body.

[0016] As a further optimized technical solution, the drawing wire is fixedly connected to the opening position near the intercepting filter.

[0017] As a further optimized technical solution, the proximal end of the balloon guidewire has a connecting section, and the inside of the filling valve body has a cavity for the flow of filling medium. The connecting section is used to be inserted into the cavity and detachably connected to the filling valve body.

[0018] As a further optimized technical solution, the outer side of the connecting section has an external thread, and the cavity of the filling valve body has an internal thread that matches the external thread.

[0019] As a further optimized technical solution, the proximal end of the connecting section has a tapered guide portion to facilitate insertion into and connection with the filling valve body.

[0020] As a further optimized technical solution, the filter body has a constant diameter section and a converging diameter section, with the converging diameter section located at the far end.

[0021] As a further optimized technical solution, the balloon body is positioned within a constant diameter section.

[0022] Beneficial Effects: Compared to traditional distal interceptor filters, the intracranial embolism protection device of this invention features a balloon guidewire. The distal end of the guidewire comprises a balloon body and an interceptor filter. Part of the balloon body is located inside the interceptor filter, while a portion extends beyond it. The guidewire enters the blood vessel via a delivery catheter and advances to the distal end of the embolism site, allowing the balloon body to be positioned within the filter. When inflated, the balloon body fully supports the filter, increasing its adhesion to the vessel wall and effectively preventing edge leakage caused by changes in vessel diameter, conical shape, or irregular shape. Furthermore, after balloon inflation, the device temporarily blocks forward blood flow. At this time, the interceptor filter, under the influence of the balloon body, is already fully adhered to the vessel wall. When the balloon contracts, small emboli enter the filter with the blood flow, allowing the filter to efficiently intercept and collect them in a relatively stable blood flow environment. In other words, the interceptor filter and the balloon work together. On the one hand, the balloon can further support the interceptor filter, allowing it to fit more closely to the inner wall of the blood vessel, effectively solving the problem of leakage at the edge of traditional distal filters. On the other hand, the balloon can effectively block forward blood flow, weaken the flushing of emboli by the blood flow, prevent emboli from escaping, and make it easier for emboli to be captured by the interceptor filter.

[0023] Furthermore, the removable inflation valve at the proximal end of the balloon guidewire of this invention does not require installation when the balloon guidewire is providing guidance, thus facilitating the subsequent placement of other therapeutic devices at the treatment site. When the balloon needs to be inflated after the placement of other therapeutic devices, the inflation valve is installed at the proximal end of the balloon guidewire to control the inflation and deflation of the balloon. This design greatly expands the applicability of the device and meets diverse clinical needs. Attached Figure Description

[0024] The accompanying drawings, which form part of this application, are used to provide a further understanding of the invention. The illustrative embodiments of the invention and their descriptions are used to explain the invention and do not constitute an undue limitation of the invention. Wherein:

[0025] Figure 1 This is a schematic diagram of the overall structure of one embodiment of the intracranial embolism protection device of the present invention;

[0026] Figure 2 This is a schematic diagram showing the disassembled state of the balloon guidewire and intercepting filter in one embodiment of the intracranial embolism protection device of the present invention.

[0027] Figure 3 for Figure 1 A magnified structural diagram of part A in the middle;

[0028] Figure 4 This is a schematic cross-sectional view of the balloon guidewire of one embodiment of the intracranial embolism protection device of the present invention.

[0029] In the diagram: 100, balloon guidewire; 101, guidewire body; 102, protective layer; 103, filling channel; 110, balloon body; 120, connecting section; 121, guide section; 200, filling valve body; 210, cavity; 300, interception filter; 320, filter body; 330, fixing block; 340, pull wire; 400, delivery conduit. Detailed Implementation

[0030] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention are within the scope of protection of the present invention.

[0031] In the description of this invention, the terms "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," and "bottom," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and do not require the invention to be constructed and operated in a specific orientation; therefore, they should not be construed as limitations on the invention. The terms "connected" and "linked" used in this invention should be interpreted broadly. For example, they can refer to a fixed connection or a detachable connection; they can refer to a direct connection or an indirect connection through intermediate components. Those skilled in the art can understand the specific meaning of the above terms according to the specific circumstances. Furthermore, the term "proximal end" uniformly refers to the end closer to the operator, while "distal end" refers to the end farther from the operator.

[0032] The present invention will now be described in detail with reference to the accompanying drawings and embodiments. It should be noted that, unless otherwise specified, the embodiments and features described herein can be combined with each other.

[0033] The shapes and sizes of the components in the accompanying drawings do not reflect the actual proportions of the product; they are only intended to illustrate the content of the invention.

[0034] In neurointerventional surgery, traditional intracranial embolism protection devices have drawbacks. The distal intercepting filter cannot fully conform to the vessel wall, leading to embolism leakage at the edge. To address this technical problem, this invention provides an intracranial embolism protection device. The core components of this device include a balloon guidewire 100, an inflation valve 200, and an intercepting filter 300. When the balloon 110 is not inflated, the balloon guidewire 100 acts as a guide wire, guiding other therapeutic instruments to the target location. After the balloon 110 is inflated, it supports the intercepting filter 300. The inflation valve 200 is detachably connected to the proximal end of the balloon guidewire 100. When the balloon guidewire 100 functions as a guide wire, the inflation valve 200 is removed. When it is necessary to inflate or deflate the balloon 110, the inflation valve 200 is installed, allowing connection to an external inflation device for balloon 110 inflation / deflation. The balloon body 110 is positioned within the interceptor filter 300. After inflation, it internally supports the interceptor filter 300, ensuring a tight fit against the vessel wall and preventing embolism leakage. Furthermore, the proximal retrieval unit of the interceptor filter 300 facilitates postoperative retrieval; the specially designed connecting section 120 of the balloon guidewire 100 ensures a secure and sealed connection with the filling valve body 200. This device, through the coordinated operation of the balloon body 110 and the interceptor filter 300, effectively improves the fit of the interceptor filter 300, blocks distal blood flow to assist thrombus aspiration, and the detachable filling valve body broadens its applicability, providing a safer and more efficient protection solution for intracranial embolization surgery.

[0035] Example 1

[0036] like Figure 1 , Figure 2 , Figure 4 As shown, the intracranial embolism protection device includes a balloon guidewire 100, an inflation valve body 200, and a delivery catheter 400.

[0037] The distal end of the balloon guidewire 100 is provided with an automatically inflatable interceptor filter 300. A balloon body 110 is located at the proximal opening of the interceptor filter 300. The balloon guidewire 100 has an inflatable section and a bare wire section located distal to the inflatable section. The inflatable section has a guidewire body 101, and a protective layer 102 is provided on the outside of the guidewire body 101. The bare wire section extends distally from the guidewire body 101 and is used to connect to the distal end of the interceptor filter 300. The guidewire body 101 is made of medical-grade nickel-titanium alloy, possessing both good flexibility and support, and can adapt to the complex tortuous paths of blood vessels. The protective layer 102 is made of a biocompatible polymer material and wraps around the outside of the guidewire body 101, effectively reducing friction and damage to the inner wall of the blood vessel. An axially extending filling channel 103 is formed between the guidewire body 101 and the protective layer 102, and the balloon body 110 is connected to the filling channel 103. In this way, the filling channel 103 provides a convenient transmission path for the filling medium for the inflation and deflation of the balloon body 110. The balloon body 110 is made of highly elastic medical-grade silicone material, which can expand radially under the action of the filling medium. The filling valve body 200 is detachably disposed at the proximal end of the guidewire body 101, and the proximal end of the filling valve body 200 is used to connect an external filling device (such as a pressure pump) to inflate and deflate the balloon body 110. The intercepting filter 300 is made of self-expanding nickel-titanium alloy wire, which has good shape memory characteristics. In the contracted state, it is delivered to the distal end of the stenotic lesion along with the balloon guidewire 100 by the delivery catheter 400. After release, it automatically expands to initially conform to the contour of the blood vessel. Part of the balloon body 110 is placed inside the intercepting filter 300, and another part extends from the proximal end of the intercepting filter 300. When the balloon body 110 expands radially, it can form a uniform support force on the intercepting filter 300 from the inside, further making the intercepting filter 300 fit tightly against the inner wall of the blood vessel and effectively preventing small emboli from leaking from the edge of the intercepting filter 300.

[0038] In this embodiment, the intercepting filter 300 includes a filter body 320. The filter body 320 can be a single-layer structure with small mesh size, or it can be a double-layer structure design. The outer layer is a skeleton layer formed by coarse filament weaving, providing a stable support structure, while the inner layer is an intercepting layer woven with fine filaments. The pore size is fine and uniform, which can effectively intercept emboli of different sizes. A retrieval unit is coaxially provided at the proximal end of the filter body 320. Its function is to facilitate the safe and smooth removal of the filter body 320 from the patient's body after the operation by retracting it.

[0039] Furthermore, the recovery unit includes a fixing block 330 and a pull wire 340. The fixing block 330 is made of medical-grade plastic or medical-grade metal and is fixedly mounted on the balloon guidewire 100 and located near the intercepting filter 300. Multiple pull wires 340 are evenly arranged around the circumference of the intercepting filter 300 and are made of high-strength and flexible medical metal wire. One end of each pull wire 340 is fixedly connected to the fixing block 330, and the other end is fixedly connected to the opening near the intercepting filter 300. The purpose of this arrangement is to close the opening of the intercepting filter 300 as quickly as possible when the intercepting filter 300 is contracted, thereby preventing emboli from escaping.

[0040] like Figure 3 As shown, the balloon guidewire 100 has a connecting section 120 at its proximal end, and the filling valve body 200 has a cavity 210 for the flow of filling medium inside. The connecting section 120 is used to be inserted into the cavity 210 and detachably connected to the filling valve body 200.

[0041] To facilitate the connection between the balloon guidewire 100 and the inflation valve body 200, the distal end of the connecting section 120 features a tapered outer diameter design. The end closer to the inflation valve body 200 has a smaller outer diameter, forming a tapered guide portion 121 for easy insertion into the cavity 210 of the inflation valve body 200. The outer diameter gradually increases towards the inflation valve body 200, matching the outer diameter of the balloon guidewire 100, increasing stability during connection. Simultaneously, the connecting section 120 has a high-precision external thread, and the cavity 210 of the inflation valve body 200 has a matching internal thread. This threaded connection not only ensures a secure connection but also guarantees good sealing, preventing leakage during balloon inflation and deflation. Furthermore, the tapered guide portion 121 at the proximal end of the connecting section 120 can have a smooth transition design, effectively reducing the difficulty of inserting the inflation valve body 200 and improving surgical efficiency.

[0042] Furthermore, the filter body 320 has a constant-diameter section and a tapering section, with the tapering section located at the distal end. The constant-diameter section of the filter body 320 adopts a cylindrical structure, and its diameter is standardized according to the common blood vessel inner diameter size, which can adapt to the blood vessels of most patients. The tapering section is located at the distal end and adopts a conical structure. The gradually narrowing design helps to reduce obstruction to blood flow in the blood vessel. At the same time, during the interception of emboli, it can guide the emboli to gather towards the center of the filter, improving the interception effect. The balloon body 110 is located within the constant-diameter section, which can make full use of the space of the constant-diameter section to effectively support the interception filter 300 and ensure that the interception filter 300 fits tightly against the inner wall of the blood vessel.

[0043] Before performing intracranial embolization protection surgery, the doctor first selects an appropriate intracranial embolization protection device based on the patient's angiographic images. During the surgery, the patient is anesthetized, and then a puncture is performed at the vascular puncture site. After successful puncture, the delivery catheter 400 (used to establish a pathway from the puncture site to the lesion) is placed proximal to the lesion, and the balloon guidewire 100 is slowly advanced into the delivery catheter 400. Utilizing the good flexibility and support of the guidewire body 101 of the balloon guidewire 100, under the real-time guidance of the angiography equipment, the balloon guidewire 100 is advanced along the blood vessel, gradually navigating the complex vascular path until it reaches the distal end of the stenotic lesion, at which point the delivery catheter 400 is withdrawn. At this point, the balloon body 110 is in an uninflated, flat state; its soft material and small outer diameter effectively reduce irritation and damage to the vascular wall during passage within the blood vessel. After the balloon guidewire 100 reaches the predetermined position, the delivery catheter 400 is slowly pulled proximally while the balloon guidewire 100 is pushed distally, causing the intercepting filter 300 and the balloon body 110 to be released together. After the intercepting filter 300 is released, the delivery catheter 400 is withdrawn. Due to the self-expanding design of the intercepting filter 300, it automatically expands after being freed from the constraint of the delivery catheter 400. The outer skeleton layer of the filter body 320 quickly forms a stable support structure, and the inner intercepting layer unfolds to form a dense interception barrier. Subsequently, the inflation valve 200 is installed at the proximal end of the balloon guidewire 100, and the proximal end of the inflation valve 200 is connected to the inflation device. The doctor operates the inflation device to inject physiological saline or other inflation media into the balloon body 110. Under the pressure of the inflation media, the balloon body 110 gradually expands radially. As the balloon 110 expands, it provides uniform support to the intercepting filter 300 from the inside, causing the filter body 320 of the intercepting filter 300 to fit tightly against the inner wall of the blood vessel. This effectively fills the gap between the filter body 320 and the blood vessel wall caused by the irregular shape of the blood vessel, preventing emboli from leaking from the edges.

[0044] During procedures such as dilation of stenosis or stent implantation, the balloon 110, once fully inflated, can temporarily block distal blood flow, significantly reducing blood flow velocity at the lesion site. This device is particularly suitable for locations with compensating vessels distal to the lesion; when this location is temporarily blocked, the distal vessel can compensate, thus not affecting the patient in the short term. After stent deployment, the surgeon performs negative pressure aspiration of the thrombus at the lesion site. Because distal blood flow is blocked, the chance of emboli escaping is reduced. Small emboli that escape during the procedure temporarily accumulate near the proximal end of the balloon 110. After thrombus aspiration is complete, the surgeon operates the inflation device to remove the inflation medium from the balloon 110, removes the inflation valve 200, and the balloon 110 gradually contracts. At this point, thanks to the support provided by the balloon 110, the intercepting filter 300 has fully adhered to the blood vessel wall. After the balloon 110 contracts, blood flow resumes, and tiny emboli enter the intercepting filter 300 with the blood flow. The inner intercepting layer of the filter body 320, with its fine pore design, can efficiently intercept and collect these emboli.

[0045] After the procedure, the delivery catheter 400 is reinserted. The balloon guidewire 100 can then be pulled proximally, moving further proximally via the fixation block 330. The traction wire 340 is tightened under the action of the fixation block 330, and the fixation block 330, once inside the delivery catheter 400, restricts the distal ends of all traction wires 340 from gradually approaching each other, causing the filter body 320 to gradually contract, bringing the outer skeleton layer and inner interception layer together. Once the filter body 320 has contracted to the appropriate state, the surgeon slowly withdraws the contracted interception filter 300 along with the delivery catheter 400, completing the entire surgical procedure. Post-operatively, the patient is closely monitored and cared for to ensure a good recovery.

[0046] In summary, the intracranial embolism protection device provided by this invention effectively solves the problems in the prior art through the structural design of the guidewire, improves the interception and removal of emboli in neurointerventional surgery, and has good clinical application prospects and promotion value.

[0047] It is understood that the above description is merely exemplary and the embodiments of this application do not limit the scope of the application.

[0048] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention shall be within the scope of protection of the pending claims of the present invention.

Claims

1. An intracranial embolic protection device, characterized in that The application relates to a balloon guide wire (100) provided with an automatically inflatable intercepting screen (300) at the distal end of the balloon guide wire (100), wherein a balloon body (110) is arranged at the opening position of the proximal end of the intercepting screen (300), and the balloon guide wire (100) has a filling section and a bare wire section at the distal end of the filling section; the filling section has a guide wire body (101) provided with a protective layer (102) outside the guide wire body (101), and an axially extending filling channel (103) is formed between the guide wire body (101) and the protective layer (102); the distal end of the protective layer (102) is provided with the balloon body (110) which is in communication with the filling channel (103); a filling valve body (200) is detachably arranged at the proximal end of the guide wire body (101) and is used for connecting a filling device to inflate and deflate the balloon body (110); a delivery catheter (400) is used for delivering the balloon guide wire (100) to the distal end of a lesion stenosis position; the balloon body (110) is arranged in the intercepting screen (300) in a part and extends out of the proximal end of the intercepting screen (300) in another part, and is used for sufficiently supporting the intercepting screen (300) when being radially expanded so that the intercepting screen (300) tightly adheres to the inner wall of a blood vessel. The intercepting screen (300) comprises a screen body (320) which is coaxially provided with a recovery unit at the proximal end, and is used for shrinking the screen body (320) when the screen body (320) is withdrawn. The recovery unit comprises a fixing block (330) arranged on the balloon guide wire (100) and a plurality of pulling wires (340), and each of the pulling wires (340) is fixedly connected to the fixing block (330) at one end and is fixedly connected to the intercepting screen (300) at the other end. The pulling wires (340) are uniformly and spacedly arranged along the circumferential direction of the screen body (320). The pulling wires (340) are fixedly connected to the opening position of the proximal end of the intercepting screen (300).

2. The intracranial embolic protection device according to claim 1, wherein, The balloon guide wire (100) has a connecting section (120) at the proximal end, the filling valve body (200) has a lumen (210) inside for the flow of filling medium, and the connecting section (120) is used for being inserted into the lumen (210) and being detachably connected to the filling valve body (200).

3. The intracranial embolic protection device according to claim 2, wherein the distal end of the elongate member is configured to be positioned in the left atrial appendage. The connecting section (120) is provided with external threads outside, and the lumen (210) of the filling valve body (200) is provided with internal threads matched with the external threads.

4. The intracranial embolic protection device of claim 3, wherein the distal end of the elongate member is configured to be positioned in the left atrial appendage. The connecting section (120) is provided with a tapered guide part (121) at the proximal end so as to facilitate the insertion into and connection with the filling valve body (200).

5. The intracranial embolic protection device according to claim 3, wherein the distal end of the elongate member is configured to be positioned in the left atrial appendage. The screen body (320) has an equal-diameter section and a reduced-diameter section, and the reduced-diameter section is arranged at the distal end.

6. The intracranial embolic protection device according to claim 1, wherein the filter is a mesh filter. The balloon body (110) is arranged in the equal-diameter section.

7. The intracranial embolic protection device according to claim 6, wherein the distal end of the elongate member is configured to be positioned in the left atrial appendage. ​ 8. The intracranial embolic protection device of claim 6, wherein the distal end of the filter is configured to be positioned in the left atrial appendage. ​ 9. The intracranial embolism protection device according to any one of claims 2-8, characterized in that, ​ 10. The intracranial embolic protection device according to claim 9, wherein the distal end of the elongate member is configured to be positioned in the left atrial appendage. ​

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