Embolism protection umbrella recycling system capable of adjusting direction and achieving safe recycling
By introducing an adjustable bending angle and limiting device into the embolism protection umbrella recovery system, the problem of the inability to adjust the direction of the traditional recovery sheath is solved, enabling safe and efficient recovery of the protection umbrella and reducing the risk of support damage and radiation exposure.
Patent Information
- Application Number
- CN202511470158.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-10-15
- Publication Date
- 2026-01-27
AI Technical Summary
Traditional embolization protection umbrella retrieval sheaths cannot be oriented during retrieval, are prone to damaging stents, rely on operator experience, leading to thrombus dislodgement and radiation exposure, and multiple attempts increase the risk of adverse events.
An adjustable embolism protection umbrella retrieval system was designed. The retrieval sheath has a 25°-35° bending angle at a specific position and is equipped with a limiting device, which allows for flexible adjustment of the retrieval end and partial retrieval of the limiting protection umbrella, thus avoiding stent embedding and thrombus dislodgement.
It improves the flexibility and safety of the recovery operation, reduces the risk of stent damage and radiation exposure, ensures efficient and safe recovery of the protective umbrella, and reduces the occurrence of adverse events.
Smart Images
Figure CN121401009A_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of medical device technology, specifically to an embolism protection umbrella recovery system. Background Technology
[0002] In neurointerventional procedures (such as thrombectomy for acute ischemic stroke and stenting for intracranial arterial stenosis), the embolization umbrella is crucial for preventing distal vascular embolism. With the widespread adoption of mechanical thrombectomy techniques, the use of the umbrella in the treatment of extracranial carotid artery occlusion and large vessel occlusion has significantly increased. Clinical studies have shown that combining the umbrella with carotid artery stenting can significantly reduce the incidence of stroke. However, the tortuous anatomy of intracranial vessels and the unique characteristics of endovascular treatment pose specific challenges to umbrella retrieval. Traditional embolization umbrella retrieval sheaths involve first advancing the non-adjustable retrieval end along the guidewire to the lower end of the umbrella, then, under X-ray irradiation, retracting the umbrella partially or completely into the retrieval end based on real-time images, and finally withdrawing both the retrieval end and the umbrella together. However, this procedure faces three problems:
[0003] 1. If a stent has been implanted proximally to the protective umbrella or there is a previous stent implantation, especially if the implanted stent is not apposed to the vessel wall at both ends but is suspended proximally in the blood vessel (such as the aortic arch), there is a certain risk that the non-adjustable retrieval end may become stuck proximally to the stent during the process of the retrieval end ascending to the lower edge of the protective umbrella. Since the retrieval end does not have the function of adjusting direction and the protective umbrella must be retrieved, repeated attempts to pass the retrieval end through the stent-prone area may damage the stent function or even cause stent displacement, leading to poor apposition to the vessel wall and increasing the probability of adverse events such as in-stent restenosis.
[0004] 2. Assuming the retrieval end has successfully reached the lower edge of the protective umbrella, the next step, under X-ray irradiation, is to partially or completely retract the protective umbrella into the retrieval end, based on the radiopaque markings at both ends and the retrieval end. However, traditional retrieval ends lack a limiting design, and the extent to which the protective umbrella is retracted depends heavily on the operator's experience, feel, and real-time fluoroscopic images. If the protective umbrella has captured a significant amount of thrombus, the inner diameter of the retrieval end may limit its retraction, potentially dislodging some thrombi and causing serious complications. Therefore, in this situation, the operator must rely on real-time fluoroscopic images, experience, and feel to precisely retract the edge of the protective umbrella into the retrieval end, leaving most of the umbrella body outside. This procedure not only tests the operator's experience and skill but also poses a greater potential radiation hazard to both the operator and the patient.
[0005] 3. Assuming the stent containing thrombus has been successfully partially retrieved into the retrieval end, if endovascular treatment (such as stent implantation) has been performed proximal to the stent, there is a chance that the stent containing thrombus may become lodged distal to the stent. The traditional approach is to withdraw the stent and try again, or to withdraw it and then fully retrieve the stent into the retrieval end before attempting retrieval again. However, as mentioned in point 2, if the stent has captured a significant amount of thrombus, fully retrieving it into the retrieval end increases the risk of serious adverse events. Furthermore, multiple retrieval attempts may also damage stent function, increasing the risk of adverse events.
[0006] Based on the three pain points of the current embolism protection umbrella recovery sheath mentioned above, there is an urgent need to develop an adjustable, safe, efficient, and easy-to-use embolism protection umbrella recovery sheath. Summary of the Invention
[0007] To address the problems existing in the prior art, the present invention provides an adjustable and safe embolism protection umbrella recovery system to solve at least one of the above-mentioned technical problems.
[0008] To achieve the above objectives, the present invention provides an adjustable and safe embolism protection umbrella retrieval system, comprising a retrieval sheath, an embolism protection umbrella, and a guide wire, characterized in that the retrieval sheath has a bending angle of 25°-35° at a position 5mm-10mm from the tip.
[0009] The inner wall of the recovery sheath at the bend is fixed with a limiting device for limiting the recovery of the embolism protective umbrella portion into the recovery sheath;
[0010] When the embolization protection umbrella abuts against the limiting device, the portion of the embolization protection umbrella located outside the recovery sheath has an expanded umbrella-like structure.
[0011] More preferably, the recovery sheath has a 30° bend at a position 10 mm from the head end.
[0012] More preferably, the limiting device includes a decreasing transition section with decreasing inner diameter and an increasing transition section with increasing inner diameter connected sequentially along the axial direction from the adjacent head end to the distance from the head end;
[0013] The decreasing transition section is used to hold the embolism protective umbrella in place.
[0014] More preferably, the inner diameter at the minimum inner diameter of the limiting device is greater than the outer diameter of the guide wire, but smaller than the outer diameter of the end of the embolization umbrella.
[0015] More preferably, the sidewall of the recovery sheath is provided with a guide wire perforation for the guide wire to pass through.
[0016] More preferably, the embolism protection umbrella includes a proximal imaging ring, an expansion wire skeleton, and a distal imaging ring along the axial direction;
[0017] The proximal developing ring and the distal developing ring are respectively fixed at both ends of the expanded wire skeleton.
[0018] More preferably, the proximal end of the recovery sheath is formed as the operating end;
[0019] When the embolism protection umbrella abuts against the limiting device, the proximal imaging ring abuts against the decreasing transition section;
[0020] The expansion wire skeleton is partially housed in the recovery sheath, and partially exposed outside the recovery sheath. The area of the expansion wire skeleton exposed outside the recovery sheath forms the expansion umbrella-shaped structure.
[0021] More preferably, the limiting device is provided with an abutting portion for abutting the axial end of the embolism protective umbrella;
[0022] The axial length from the head end of the recovery sheath to the abutment is not less than 1 / 2 of the axial length of the embolization protection umbrella, and not greater than 3 / 4 of the axial length of the embolization protection umbrella.
[0023] More preferably, the axial length from the head end of the recovery sheath to the abutment is 1 / 2 of the axial length of the embolization umbrella.
[0024] Compared with the prior art, the beneficial effects of the present invention are:
[0025] Technically, the retrieval end of the protective umbrella sheath offers greater operational flexibility. When encountering special vascular anatomy, or when the retrieval sheath, carrying a partially retrieved protective umbrella, becomes stuck in a stent during its ascent or descent, the operator can slightly retract and externally rotate the outer end of the retrieval sheath. This allows the retrieval end to pass more easily through structures that are difficult to access with traditionally non-adjustable retrieval ends or ends carrying incompletely retrieved protective umbrellas. Furthermore, when retrieving the protective umbrella into the retrieval end, it no longer relies excessively on the operator's extensive experience, feel, or excessive radiation exposure. The operator can efficiently and quickly retrieve the protective umbrella to the ideal extent, without worrying about thrombus dislodgement due to over- or under-retrieval, or cerebral ischemia or neothrombus formation caused by inefficient operation.
[0026] From a safety perspective, the highly flexible retrieval end, whether ascending along the guidewire or descending with the partially retrieved protective umbrella, eliminates the potential damage to endovascular treatment devices (such as stents) caused by repeated attempts when direct passage is not possible using conventional methods. This reduces the probability of in-stent restenosis and other adverse events due to stent damage. Simultaneously, thanks to our limiting design, the operator can quickly and accurately retrieve the protective umbrella containing the thrombus, reducing the probability of serious adverse events such as thrombus escape caused by excessive or insufficient retrieval. Furthermore, the efficient retrieval operation reduces the risk of downstream cerebral ischemia or neothrombus formation due to slow operation. In addition, the limiting design of the retrieval end allows for accurate retrieval of the protective umbrella without fluoroscopy, effectively reducing the radiation exposure received by both the patient and the operator during umbrella retrieval. These small reductions significantly minimize the potential harm from radiation to both parties. Attached Figure Description
[0027] Figure 1 This is a schematic diagram of the structure of the present invention when the embolization protection umbrella abuts against the limiting device;
[0028] Figure 2 This is a cross-sectional view of the sheath used in the present invention;
[0029] Figure 3 This is a schematic diagram of the structure of the recyclable sheath of the present invention.
[0030] 1 is the recovery sheath, 2 is the guide wire outlet, 3 is the limiting device, 4 is the embolization protection umbrella, and 5 is the guide wire. Detailed Implementation
[0031] The present invention will now be further described with reference to the accompanying drawings.
[0032] See Figures 1 to 3 Specific embodiment 1: An adjustable and safe embolism protection umbrella retrieval system includes a retrieval sheath 1, an embolism protection umbrella 4, and a guide wire 5. The retrieval sheath 1 has a 25°-35° bend at a distance of 5mm-10mm from the tip. The inner wall of the retrieval sheath 1 at the bend is fixed with a limiting device 3 for limiting the retrieval of part of the embolism protection umbrella 4 into the retrieval sheath 1. When the embolism protection umbrella 4 abuts against the limiting device 3, the portion of the embolism protection umbrella 4 outside the retrieval sheath 1 has an expanded umbrella-shaped structure.
[0033] The recovery sheath 1 has a 30° bend at a position 10 mm from the tip.
[0034] The retrieval end of the protective umbrella retrieval sheath has a 30° bend at a specific distance of 10mm from the tip. This bend allows the retrieval end to be directionally adjustable as it ascends along guidewire 5. In cases involving special vascular anatomy, stent implantation in the proximal segment of the protective umbrella, or even when the proximal stent is suspended in the blood vessel, the operator can externally rotate the outer end of the retrieval sheath, giving it greater flexibility and mobility to pass through structures that are difficult for traditionally non-adjustable retrieval ends.
[0035] To address the following technical issues: the retrieved end may become stuck at the proximal end of the stent during the upward movement of the guidewire: In the current technology, if a stent is implanted in a vessel proximal to the umbrella-shaped vessel, especially if both ends of the stent are not attached to the vessel wall but are suspended in the vessel (such as the aortic arch), the retrieved end may become stuck at the proximal end of the stent during the upward movement of the guidewire 5. Repeated attempts may damage the stent function and have adverse effects.
[0036] With this bend, the retrieval end has greater flexibility and maneuverability when leading the partially retrieved protective umbrella out. If the umbrella body outside the retrieval end is stuck in the support, in addition to retracting and trying again, it provides the operator with an additional means to adjust the angle of the retrieval end and the protective umbrella by rotating the outer end of the protective umbrella retrieval sheath externally, thereby increasing the possibility of passing through the stuck area.
[0037] The following technical problem needs to be addressed: During the overall retrieval process, the partially retrieved protective umbrella and retrieval end may become lodged by the distal end of the stent. Under current technology, when the partially retrieved protective umbrella is withdrawn along with the retrieval end, there is a certain probability that the umbrella will become lodged by the distal end of the stent implanted at the endovascular treatment site. In this case, the only options are to return and try again, or to return and re-retrieve the entire umbrella before trying again. The former may lead to serious adverse events due to damage to the stent structure and excessive time consumption, while the latter faces the same problem of thrombus dislodgement when the entire umbrella is re-retrieved.
[0038] See Figure 2 as well as Figure 3 In specific embodiment 2, based on the specific embodiment, the limiting device 3 includes a decreasing transition section with decreasing inner diameter and an increasing transition section with increasing inner diameter connected sequentially along the axial direction from the adjacent head end to the distance from the head end; the decreasing transition section is used to abut against the embolism protective umbrella 4. The angle between the decreasing transition section and the radial section is 45°. The angle between the increasing transition section and the radial section is 45°.
[0039] The decreasing transition section and the increasing transition section are connected by a convex arc-shaped transition section. Both the decreasing and increasing transition sections are conical in shape.
[0040] The inner diameter of the limiting device 3 at its minimum inner diameter is greater than the outer diameter of the guide wire 5, but less than the outer diameter of the end of the embolization umbrella 4.
[0041] The side wall of the recovery sheath 1 is provided with a guide wire perforation 2 for the guide wire to pass through. The guide wire 5 is fixedly connected to the embolization protection umbrella 4.
[0042] The embolization protection umbrella 4 includes a proximal imaging ring, an expansion wire skeleton, and a distal imaging ring along the axial direction; the proximal imaging ring and the distal imaging ring are fixed at both ends of the expansion wire skeleton, respectively.
[0043] The proximal end of the recovery sheath 1 is formed as the operating end; when the embolization protection umbrella 4 abuts against the limiting device 3, the proximal imaging ring abuts against the decreasing transition section; the expansion wire skeleton is partially housed in the recovery sheath 1, and the expansion wire skeleton is partially exposed outside the recovery sheath 1, forming an expansion umbrella-shaped structure in the area where the expansion wire skeleton is exposed outside the recovery sheath 1.
[0044] The limiting device 3 is provided with an abutment part for abutting the axial end of the embolization protection umbrella 4; the axial length from the head end of the recovery sheath 1 to the abutment part is not less than 1 / 2 of the axial length of the embolization protection umbrella 4 and not greater than 3 / 4 of the axial length of the embolization protection umbrella 4.
[0045] The axial length from the tip of the recovery sheath 1 to the contact point is half the axial length of the embolization umbrella 4.
[0046] This invention uses a limiting device to allow only the guidewire to pass through, preventing the guidewire and the tightened umbrella edge from passing through simultaneously. Simultaneously, the tip of the retrieval sheath is designed to just accommodate all the umbrella edges being retracted into the retrieval end, while the vast majority of the umbrella body is prevented from being retracted. This limiting design allows the operator to quickly and efficiently retrieve the protective umbrella to the ideal position even without fluoroscopy (i.e., without radiation), while avoiding situations where improper operation or lack of experience leads to thrombus dislodgement and increased radiation exposure for both the patient and the operator.
[0047] The following problems were solved: The protective umbrella for capturing thrombi cannot be efficiently and quickly partially retrieved into the retrieval end to an appropriate degree, and it requires a high level of operator skill. With current technology, if a protective umbrella containing a large amount of thrombi is fully retrieved, it may cause the thrombus to be squeezed into the bloodstream, leading to serious adverse events. Whether the protective umbrella is partially or fully retrieved, the precise degree of retrieval requires the operator to accurately control it using experience, feel, and real-time fluoroscopic images, which is difficult and has a high learning curve. Operators can easily under-retrieve the umbrella edge or over-retrieve the umbrella body, causing the thrombus to be squeezed out. Especially when the umbrella body contains a large amount of thrombus affecting blood flow, it is essential to quickly and safely retrieve the protective umbrella into the retrieval end to an appropriate degree. At the same time, the operator needs to use fluoroscopic images to determine the degree of protective umbrella retrieval, resulting in both the patient and the operator receiving more radiation.
[0048] Working principle:
[0049] After angiography, ensure the delivery catheter has reached the target position. Use the guidewire 5, fixed to the embolization umbrella 4, to guide the embolization umbrella 4 to the target position along the delivery catheter. Immediately monitor the position of the embolization umbrella 4 using angiography to open it. Then begin endovascular treatment. After endovascular treatment, move this product (adjustable retrieval sheath) along the guidewire to the embolization umbrella 4. Keeping the product stationary, gently withdraw the umbrella guidewire to its maximum extent (at this point, the lower edge of the embolization umbrella 4 is in contact with the limiting device of this product). Then, keeping the relative positions of the umbrella guidewire and this product fixed, withdraw them together from the body, completing the use of this product. The above is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.
Claims
1. An adjustable-direction, safe-recovery embolism protection umbrella recovery system, comprising a recovery sheath, an embolism protection umbrella, and a guidewire, characterized in that, The recovery sheath has a bend angle of 25°-35° at a position 5mm-10mm from the head end; The inner wall of the recovery sheath at the bend is fixed with a limiting device for limiting the recovery of the embolism protective umbrella portion into the recovery sheath; When the embolization protection umbrella abuts against the limiting device, the portion of the embolization protection umbrella located outside the recovery sheath has an expanded umbrella-like structure.
2. The adjustable-direction, safe-recovery embolism protection umbrella recovery system according to claim 1, characterized in that: The recovery sheath has a 30° bend at a position 10 mm from the head end.
3. The adjustable-direction, safe-recovery embolism protection umbrella recovery system according to claim 1, characterized in that: The limiting device includes a decreasing transition section with decreasing inner diameter and an increasing transition section with increasing inner diameter connected sequentially along the axial direction from the adjacent head end to the distance from the head end. The decreasing transition section is used to hold the embolism protective umbrella in place.
4. The adjustable-direction, safe-recovery embolism protection umbrella recovery system according to claim 1, characterized in that: The inner diameter at the minimum inner diameter of the limiting device is greater than the outer diameter of the guide wire, but smaller than the outer diameter of the end of the embolization umbrella.
5. The adjustable-direction, safe-recovery embolism protection umbrella recovery system according to claim 1, characterized in that: The side wall of the recovery sheath has a guide wire perforation for the guide wire to pass through.
6. The adjustable-direction, safe-recovery embolism protection umbrella recovery system according to claim 3, characterized in that: The embolization protection umbrella includes a proximal imaging ring, an expansion wire skeleton, and a distal imaging ring along the axial direction. The proximal developing ring and the distal developing ring are respectively fixed at both ends of the expanded wire skeleton.
7. The adjustable-direction, safe-recovery embolism protection umbrella recovery system according to claim 6, characterized in that: The proximal end of the recovery sheath is formed as the operating end; When the embolism protection umbrella abuts against the limiting device, the proximal imaging ring abuts against the decreasing transition section; The expansion wire skeleton is partially housed in the recovery sheath, and partially exposed outside the recovery sheath. The area of the expansion wire skeleton exposed outside the recovery sheath forms the expansion umbrella-shaped structure.
8. The adjustable-direction, safe-recovery embolism protection umbrella recovery system according to claim 7, characterized in that: The limiting device is provided with an abutting part for abutting the axial end of the embolism protective umbrella; The axial length from the head end of the recovery sheath to the abutment is not less than 1 / 2 of the axial length of the embolization protection umbrella, and not greater than 3 / 4 of the axial length of the embolization protection umbrella.
9. The adjustable-direction, safe-recovery embolism protection umbrella recovery system according to claim 8, characterized in that: The axial length from the tip of the recovery sheath to the abutment is half the axial length of the embolization umbrella.
10. The adjustable-direction, safe-recovery embolism protection umbrella recovery system according to claim 3, characterized in that: The angle between the decreasing transition section and the radial section is 45°, and the angle between the increasing transition section and the radial section is 45°. The decreasing transition section and the increasing transition section are connected by an outwardly convex arc-shaped transition section; Both the decreasing transition section and the increasing transition section are conical in shape.