Balloon-assisted shuttle device for treating atherosclerosis and methods of use

Abstract

This invention relates to a balloon-assisted shuttle device and its method of use for treating atherosclerosis. The device includes a connecting catheter, with an aspiration catheter fixedly mounted at its left end, a guiding catheter fixedly mounted at its left end, and a microguidewire fixedly mounted at its left end. A balloon is fixedly mounted on the outer surface of the aspiration catheter. The aspiration catheter has contrast markers, and the guiding catheter has a detection mechanism fixedly mounted on its outer surface. This invention adds a midpoint contrast point to the balloon. The balloon originally has two contrast markers; adding a midpoint facilitates locating the narrowest part of the lesion and allows for effective observation of the aspiration catheter's passage through the narrowed lesion to the distal end. The two contrast markers on the balloon indicate its length; adding a midpoint facilitates measurement and provides a reference for stent selection.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a balloon-assisted shuttle device for treating atherosclerosis and its usage method. Background Technology

[0003] Currently, the two most effective treatments for ischemic stroke are intravenous thrombolysis and mechanical thrombectomy. However, intravenous thrombolysis has a low recanalization rate and poor therapeutic effect in strokes caused by large vessel occlusion. In recent years, with the development of interventional materials and techniques, endovascular therapy has significantly improved the recanalization rate of occluded vessels and extended the treatment time window, showing promising application prospects. Multiple studies suggest that endovascular therapy can significantly improve the clinical prognosis of patients with acute large vessel occlusion.

[0004] However, stent thrombectomy for acute large vessel occlusion on the basis of atherosclerotic stenosis has certain limitations. Because of the persistent stenosis, patients with acute large vessel occlusion on the basis of atherosclerotic stenosis are prone to re-thrombosis or re-occlusion due to slow blood flow during endovascular treatment, which is a cause of refractory occlusion. Studies have shown that the more severe the stenosis, the greater the likelihood of re-occlusion after thrombectomy. The mechanism of acute large vessel occlusion on the basis of atherosclerotic stenosis involves the formation of a new thrombus occluding the vessel on the basis of moderate to severe stenosis. In situ thrombi in acute large vessel occlusion on the basis of atherosclerotic stenosis adhere to the plaque at the stenotic site. After stent release, it may not be able to fully deploy, and intimal damage, thrombus escape after stenosis, arterial dissection, vasospasm, etc., may occur. Continued treatment of the stenotic lesion is still required after stent thrombectomy. If blood flow cannot be maintained at mTICI grade 2b or above, salvage measures such as balloon angioplasty or stent implantation are necessary.

[0005] As mentioned above, the treatment of acute large vessel occlusion on the basis of severe stenosis is still under investigation. The BAT technique, which uses a balloon-assisted aspiration catheter to bypass the stenosis and focus on thrombus aspiration while simultaneously treating the stenosis, rapidly opens the vessel, improves clinical outcomes, shortens recanalization time, and reduces surgical procedures and costs. Therefore, the BAT technique may provide an effective method for improving clinical outcomes in treating acute large vessel occlusion on the basis of stenosis. Summary of the Invention

[0006] To address the shortcomings of existing technologies, this invention provides a balloon-assisted shuttle device and its usage method for treating atherosclerosis. It offers advantages such as rapid opening of blood vessels and restoration of blood flow. This addresses the limited application of balloon-assisted shuttle technology (BAT) in acute ischemic stroke with large vessel occlusion on the basis of atherosclerosis. A review of relevant domestic and international literature reveals numerous reports on stent thrombectomy for large vessel occlusion in acute ischemic stroke. However, these cases typically involve severe stenosis combined with thrombosis, and even after stent thrombectomy, further treatment of the stenosis is still necessary, requiring remedial measures such as balloon dilation or stent implantation.

[0007] To achieve the above objectives, the present invention provides the following technical solution: a balloon-assisted shuttle device for treating atherosclerosis, comprising a connecting catheter, an aspiration catheter fixedly installed at the left end of the connecting catheter, a guiding catheter fixedly installed at the left end of the aspiration catheter, a microguidewire fixedly installed at the left end of the guiding catheter, a balloon fixedly installed on the outer surface of the aspiration catheter, a contrast marker provided on the aspiration catheter, a detection mechanism fixedly installed on the outer surface of the guiding catheter, and a display film fixedly installed on the outer surface of the aspiration catheter;

[0008] The detection mechanism includes a mounting shaft, which is fixedly mounted on the guide tube. The outer surface of the mounting shaft has a mounting groove, and a sleeve is fitted on the outer surface of the mounting groove. A miniature detection probe is fixedly mounted on the outer surface of the sleeve, and a wire is fixedly mounted inside the sleeve.

[0009] Preferably, the aspiration catheter is fitted inside the connecting catheter, and the right end of the balloon is fixedly connected to the connecting catheter.

[0010] Preferably, the aspiration catheter can be a 5F aspiration catheter or a 6F aspiration catheter, and the balloon is a pre-dilated intracranial balloon of 2.0-2.5mm × 15mm.

[0011] Preferably, the inner diameter of the guiding catheter gradually decreases from right to left, the imaging mark is located at the center between the two imaging films, and the surface of the imaging films is silver.

[0012] Preferably, the outer surfaces of the connecting catheter, balloon, and guiding catheter are all coated with a PVP hydrophilic coating.

[0013] Preferably, the right end of the mounting shaft is fixedly connected to the balloon, the miniature detection probes are arranged in a ring at equal intervals, the left ends of the wires are electrically connected to the corresponding miniature detection probes, and the left ends of the wires pass through the suction catheter and the connecting catheter to connect to an external power source.

[0014] A method of using a balloon-assisted shuttle device for treating atherosclerosis, comprising the method of using the balloon-assisted shuttle device described in any one of the above claims, characterized in that: the method of use is specifically as follows:

[0015] 1) Select a 6F aspiration catheter to contact the occluded site for aspiration and remove the proximal thrombus;

[0016] 2) After aspiration, a 0.014-inch microguidewire is selected and passed through the aspiration catheter and the guiding catheter to enter the distal middle cerebral artery, basilar artery and posterior cerebral artery through the occlusion site;

[0017] 3) Insert a pre-dilated intracranial balloon with dimensions of 2.0-2.5mm × 15mm through the occlusion site. Use the imaging marker in the middle of the balloon to locate the stenosis. Cover the lesion with imaging at both ends. Dilate the balloon at 2-4 atm. While shaping the occlusion and stenosis with the balloon, do not deflate the balloon and follow the aspiration catheter to the proximal end of the balloon. Apply a certain forward pushing force to the aspiration catheter. Gradually depressurize the balloon while slowly following the aspiration catheter past the imaging point in the middle of the lesion to 1 / 3 or the end of the balloon.

[0018] 4) During the depressurization and retraction of the balloon, push the aspiration catheter to the distal end of the occlusion for aspiration. Do not force the catheter through during the pushing process.

[0019] 5) Aspirate the blood clot by inserting the aspiration catheter to the distal end of the occlusion.

[0020] Preferably, the balloon is designed to be pre-dilated according to the diameter of the target blood vessel, and is also designed to match or be slightly larger than the diameter of the aspiration catheter.

[0021] Preferably, half of the balloon 5 is hidden inside the aspiration catheter, and the other half is exposed outside the aspiration catheter and inflated at the narrow point. The balloon can assist in passage, form blood vessels, and block blood flow, while the aspiration catheter focuses on aspiration, which can provide synergistic effects in different directions.

[0022] Compared with the prior art, the technical solution of this application has the following beneficial effects:

[0023] 1. This invention employs balloon-assisted shuttle technology to improve the patency of large vessel occlusion in acute ischemic stroke on the basis of atherosclerosis. It removes thrombi while treating stenotic lesions, efficiently opening blood vessels, preventing thrombus escape, shortening vascular patency time, reducing the number of surgical procedures, and lowering surgical costs. It offers the advantage of high-efficiency patency in treating acute large vessel occlusion on the basis of atherosclerosis. By removing thrombi while treating stenotic lesions, it efficiently opens blood vessels, potentially shortening vascular patency time, avoiding damage to the vascular intima from stents, saving on stent retrieval costs, thus reducing surgical costs, simplifying the surgical procedure, reducing the number of surgical procedures, and preventing thrombus escape.

[0024] 2. This invention adds a midpoint imaging point to the balloon. The balloon originally has two imaging points; adding a midpoint improves the localization of the narrowest part of the lesion and allows for effective observation of the aspiration catheter's passage through the narrowed lesion to the distal end. The two imaging marks on the balloon indicate its length; adding a midpoint facilitates measurement and can serve as a reference for stent selection. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of the structure of the present invention;

[0026] Figure 2 This is a frontal sectional view of the detection mechanism of the present invention;

[0027] Figure 3 Right-side sectional view of the mounting axis of this invention.

[0028] In the diagram: 1. Connecting catheter; 2. Aspiration catheter; 3. Guiding catheter; 4. Microguidewire; 5. Balloon; 6. Imaging marker; 7. Detection mechanism; 701. Mounting shaft; 702. Mounting groove; 703. Sleeve; 704. Miniature detection probe; 705. Wire; 8. Display film. Detailed Implementation

[0029] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0030] Please see Figure 1-3 This embodiment of a balloon-assisted shuttle device for treating atherosclerosis includes a connecting catheter 1, an aspiration catheter 2 fixedly installed at the left end of the connecting catheter 1, a guiding catheter 3 fixedly installed at the left end of the aspiration catheter 2, a microguidewire 4 fixedly installed at the left end of the guiding catheter 3, a balloon 5 fixedly installed on the outer surface of the aspiration catheter 2, a contrast marker 6 provided on the aspiration catheter 2, a detection mechanism 7 fixedly installed on the outer surface of the guiding catheter 3, and a display film 8 fixedly installed on the outer surface of the aspiration catheter 2.

[0031] The detection mechanism 7 includes a mounting shaft 701, which is fixedly mounted on the guide tube 3. The outer surface of the mounting shaft 701 is provided with a mounting groove 702. A sleeve 703 is fitted on the outer surface of the mounting groove 702. A miniature detection probe 704 is fixedly mounted on the outer surface of the sleeve 703. A wire 705 is fixedly mounted inside the sleeve 703.

[0032] In this embodiment, the aspiration catheter 2 is disposed inside the connecting catheter 1. The right end of the balloon 5 is fixedly connected to the connecting catheter 1. Half of the balloon 5 is hidden inside the aspiration catheter 2, and the other half is exposed outside the aspiration catheter 2 and inflated at the narrow point. The balloon 5 has the functions of assisting passage, shaping blood vessels, and blocking blood flow. The aspiration catheter 2 focuses on aspiration and can provide synergistic effects in different directions.

[0033] In this embodiment, a 5F or 6F aspiration catheter is used as the aspiration catheter, and a pre-dilated intracranial balloon of 2.0-2.5mm×15mm is selected as the balloon 5 of the present invention.

[0034] In this embodiment, the guide catheter 3 is tapered, with its inner diameter decreasing from right to left. The imaging mark 6 is located between the two imaging films 8, at the center position. The imaging films are set to silver, and the imaging mark 6 is red.

[0035] In this embodiment, a PVP hydrophilic coating is sprayed onto the outer surface of the connecting catheter 1, balloon 5, and guiding catheter 3. The PVP hydrophilic coating contains a highly polar lactam group in its molecular structure, exhibiting good hydrophilicity. Upon contact with water, it rapidly absorbs water, and water molecules form a hydrogel through hydrogen bonding, thus demonstrating excellent hydrophilicity and lubricity. The PVP hydrophilic coating not only reduces the contact angle between the material and water, improving wetting performance, but also forms a lubricating film under the wetting action of water, reducing the coefficient of friction on the material surface, improving the material's wear resistance and corrosion resistance, and also possessing good antibacterial properties.

[0036] A method of using a balloon-assisted shuttle device for treating atherosclerosis, comprising the method of using the balloon-assisted shuttle device described above, characterized in that: the method of use is specifically as follows:

[0037] 1) Select a 6F aspiration catheter to contact the occluded site for aspiration and remove the proximal thrombus;

[0038] 2) After aspiration, a 0.014in microguidewire 4 is selected and passed through the aspiration catheter 2 and the guiding catheter 3 to enter the middle cerebral artery, basilar artery and distal posterior cerebral artery through the occlusion site;

[0039] 3) Pass a pre-dilated intracranial balloon with a size of 2.0-2.5mm×15mm through the occlusion site. Use the imaging marker 6 in the middle of the balloon 2 to locate the stenosis. Cover the lesion with imaging films 8 at both ends. Dilate the balloon 5 at 2-4 atm. While shaping the occlusion stenosis with the balloon 5, do not deflate the balloon 5 and follow the aspiration catheter 2 to the proximal end of the balloon 5. Apply a certain forward pushing force to the aspiration catheter 2. Gradually depress the pressure of the balloon 5 and slowly follow the aspiration catheter 2 past the imaging point in the middle of the lesion to 1 / 3 or the end of the balloon 5.

[0040] 4) During the depressurization and retraction of balloon 5, push the aspiration catheter 2 to the distal end of the occlusion for aspiration. Do not force the catheter through during the pushing process.

[0041] 5) Insert aspiration catheter 2 to the distal end of the occlusion and aspirate the blood clot.

[0042] The required technology involves a "triaxial" system consisting of a microguidewire 4, a balloon 5, and an aspiration catheter 2. The aspiration catheter 2, when docked with the balloon 5, forms a unified system, assisting the aspiration catheter 2 in aspiration distal to the stenotic lesion. The balloon 5 serves as two marker points for visualization. By increasing the visualization at the midpoint, the narrowest point of the lesion can be located, while simultaneously allowing effective observation of the aspiration catheter's position through the stenotic lesion to its distal end. The two markers on the balloon indicate its length; adding a midpoint facilitates measurement. For example, with a 12mm length, designing midpoints with 6mm points before and after can serve as a reference for measurement and stent selection. Half of the balloon 5 is concealed within the aspiration catheter 2, while the other half protrudes outside the catheter 2 at the stenosis. The balloon 5 is then inflated. The balloon 5 assists in passage, shapes the vessel, and blocks blood flow, while the aspiration catheter focuses on aspiration, providing synergistic effects in different directions. The purpose of balloon-assisted vascular endothelialization (BAL) is to create narrowed vessels in ICAS (Intravascular Coagulation). By inflating a balloon, the gap between the large-diameter aspiration catheter and the microguidewire is reduced, minimizing the razor effect and creating a seamless carrier for forward propulsion. This allows the aspiration catheter to smoothly traverse the narrowing and reach the distal end for direct aspiration. The potential advantages of BAL include rapid vascular endothelialization, reduced costs associated with stent retrieval, and the ability to prevent embolism by blocking blood flow at the site of narrowing.

[0043] By employing the above-mentioned technical solutions, balloon-assisted endovascular recanalization (BART) significantly improves the patency of large vessel occlusion in acute ischemic stroke patients with atherosclerosis. It simultaneously treats stenosis and removes thrombi, efficiently opening blood vessels, preventing thrombus escape, shortening patency time, reducing the number of surgical procedures, and lowering surgical costs. While the application of BART in acute ischemic stroke with large vessel occlusion in patients with atherosclerosis is relatively limited, it has significant social value. With increased awareness of stroke, improved stroke recognition rates, rapid development of neurointerventional techniques, and increased reperfusion therapy for patients with large vessel occlusion due to acute ischemic stroke, the use of BART in acute large vessel occlusion will become increasingly common. This will be further enhanced by improving and... Promoting this technology provides a basis for clinical endovascular interventional treatment plans, which is of positive significance for improving patients' neurological deficits and daily living abilities. It also contributes to Healthy China, implements the CSA "Haikou Declaration", and promotes the implementation of the Million Disability Reduction Project. Balloon-assisted shuttle technology is mainly used to pass through tortuous vascular lesions, spasmodic vessels, treat radial artery rupture, and carotid artery stenosis. There is limited research on balloon-assisted shuttle technology for acute large vessel occlusion lesions with severe stenosis and thrombosis. The BAT technology uses a balloon-assisted intermediate tube to pass through the stenosis for thrombus aspiration while angioplasty, treating the stenotic lesion and removing the thrombus at the same time, efficiently opening the blood vessel, shortening the vascular opening time, reducing the number of surgical operations, and reducing surgical costs.

[0044] By adopting the above technical solution, an additional mid-point of visualization is added to the balloon: The balloon originally has two visualization points; adding a mid-point facilitates locating the narrowest part of the lesion and allows for effective observation of the aspiration catheter's passage through the narrowed lesion to the distal end. The two visualization marks on the balloon indicate its length; adding a mid-point facilitates measurement and can serve as a reference for stent selection.

[0045] It should be noted that, in this document, relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes the element.

[0046] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A balloon-assisted shuttle device for treating atherosclerosis, comprising a connecting catheter (1), characterized in that: A suction catheter (2) is fixedly installed at the left end of the connecting catheter (1), a guide catheter (3) is fixedly installed at the left end of the suction catheter (2), a micro guidewire (4) is fixedly installed at the left end of the guide catheter (3), a balloon (5) is fixedly installed on the outer surface of the suction catheter (2), a contrast marker (6) is provided on the suction catheter (2), a detection mechanism (7) is fixedly installed on the outer surface of the guide catheter (3), and a display film (8) is fixedly installed on the outer surface of the suction catheter (2). The detection mechanism (7) includes a mounting shaft (701), which is fixedly mounted on the guide tube (3). The outer surface of the mounting shaft (701) is provided with a mounting groove (702), and a sleeve (703) is fitted on the outer surface of the mounting groove (702). A miniature detection probe (704) is fixedly mounted on the outer surface of the sleeve (703), and a wire (705) is fixedly mounted inside the sleeve (703).

2. The balloon-assisted shuttle device for treating atherosclerosis according to claim 1, characterized in that: The aspiration catheter (2) is fitted inside the connecting catheter (1), and the right end of the balloon (5) is fixedly connected to the connecting catheter (1).

3. The balloon-assisted shuttle device for treating atherosclerosis according to claim 1, characterized in that: The aspiration catheter (2) can be a 5F aspiration catheter or a 6F aspiration catheter, and the balloon (5) is a pre-dilated intracranial balloon of 2.0-2.5mm×15mm.

4. The balloon-assisted shuttle device for treating atherosclerosis according to claim 1, characterized in that: The inner diameter of the guiding catheter (3) gradually decreases from right to left, the imaging mark (6) is located in the center between the two imaging films (8), and the surface of the imaging film (8) is silver.

5. The balloon-assisted shuttle device for treating atherosclerosis according to claim 1, characterized in that: The outer surfaces of the connecting catheter (1), balloon (5) and guiding catheter (3) are all coated with a PVP hydrophilic coating.

6. The balloon-assisted shuttle device for treating atherosclerosis according to claim 1, characterized in that: The right end of the mounting shaft (701) is fixedly connected to the balloon (5), the miniature probes (704) are arranged in a ring at equal intervals, the left end of the wire (705) is electrically connected to the corresponding miniature probe (704), and the left end of the wire (705) passes through the suction tube (2) and the connecting tube (1) to connect to an external power source.

7. A method of using a balloon-assisted shuttle device for treating atherosclerosis, comprising the method of using the balloon-assisted shuttle device according to any one of claims 1-6, characterized in that: The specific usage method is as follows: 1) Select a 6F aspiration catheter (2) and contact the occluded site for aspiration to remove the proximal thrombus; 2) After aspiration, a 0.014in microguidewire (4) is selected and passed through the aspiration catheter (2) and the guiding catheter (3) to enter the middle cerebral artery, basilar artery and distal posterior cerebral artery through the occlusion site; 3) Pass a pre-dilated intracranial balloon with a specification of 2.0-2.5mm×15mm through the occlusion site. Use the imaging marker (6) in the middle of the balloon (2) to locate the stenosis. Cover the lesion with imaging films (8) at both ends. Dilate the balloon (5) at 2-4 atm. While shaping the occlusion stenosis with the balloon (5), do not deflate the balloon (5) and follow the aspiration catheter (2) to the proximal end of the balloon (5). Give the aspiration catheter (2) a certain forward pushing force. Gradually depress the pressure of the balloon (5) and slowly follow the aspiration catheter (2) past the lesion (middle imaging point) to 1 / 3 or the end of the balloon (5). 4) During the depressurization of the balloon (5) and the retraction of the balloon (5), push the aspiration catheter (2) to the distal end of the occlusion for aspiration. Do not force the passage during the pushing process. 5) Insert the aspiration catheter (2) to the distal end of the occlusion for aspiration and aspirate the blood clot.

8. The method of using a balloon-assisted shuttle device for treating atherosclerosis according to claim 7, characterized in that: The balloon (5) must be pre-dilated according to the diameter of the target blood vessel and must match or be slightly larger than the diameter of the aspiration catheter (2).

9. A method of using a balloon-assisted shuttle device for treating atherosclerosis as described in claim 7, characterized in that: The balloon (5) is partially hidden inside the aspiration catheter (2), and the other half is exposed outside the aspiration catheter (2) and inflated at the narrow point. The balloon (5) assists in passage, shapes blood vessels, and blocks blood flow. The aspiration catheter (2) focuses on aspiration, which can provide synergistic effects in different directions.

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