A balloon type drug delivery device applied to treatment of arteriovenous fistula stenosis

Abstract

The utility model provides a kind of balloon type dosing device applied to arteriovenous fistula stenosis treatment, it is related to medical instrument technical field.The dosing device includes: guide connecting column, is provided with first passage, second passage, third passage and fourth passage;Among them, second passage, third passage and fourth passage are independently communicated with injection channel;Expansion balloon, it is set on guide connecting column and is close to the position of export, and it is communicated with second passage;Dosing balloon, including first balloon and second balloon, first balloon is sleeved on guide connecting column, first balloon is communicated with third passage, second balloon is sleeved on first balloon, and second balloon is communicated with fourth passage;And microneedle structure, it is set on the outside of second balloon, and it is communicated with the inner chamber of second balloon.The dosing device of the present application effectively reduces the push resistance of dosing balloon, greatly reduces the risk of blood vessel injury or balloon jamming due to improper operation of doctor.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and more specifically, to a balloon-type drug delivery device for the treatment of arteriovenous fistula stenosis. Background Technology

[0002] Arteriovenous fistulas (AVFs), a common vascular access point for hemodialysis, are surgically connected arteries to veins, promoting arterialization of the veins and thus meeting the need for sufficient blood flow during dialysis. However, due to various factors such as intimal hyperplasia, thrombosis, and vascular calcification, AVFs are prone to stenosis, which in turn affects their normal function. Therefore, treatment of AVF stenosis is particularly important.

[0003] In the treatment of arteriovenous fistula stenosis, interventional vascular therapy plays a crucial role. As a cutting-edge minimally invasive treatment technology in modern medicine, interventional vascular therapy relies on the precise guidance of imaging equipment such as X-ray, ultrasound, CT, and MRI. Doctors insert interventional instruments such as catheters, guidewires, balloons, and stents into the diseased blood vessel through punctures in superficial blood vessels such as the femoral and radial arteries, completing the diagnosis and treatment procedures. It can precisely reach the diseased blood vessel, enabling accurate diagnosis of vascular diseases, effectively clearing narrowed blood vessels, blocking abnormal vascular channels, and conducting local drug delivery. With its advantages of minimal trauma, rapid recovery, and few complications, interventional vascular therapy is widely used in the treatment of cardiovascular, cerebrovascular, and peripheral vascular diseases, and has become an important and preferred method in the treatment of arteriovenous fistula stenosis. Drug delivery balloons play a crucial role in interventional vascular treatment, particularly in the treatment of arteriovenous fistula stenosis. They deliver medication directly and precisely to the lesion site, effectively inhibiting intimal hyperplasia and significantly reducing restenosis rates, thus playing a key role in improving interventional treatment outcomes and patient prognosis. In practice, guided by imaging equipment, the physician inserts a catheter carrying the drug delivery balloon through the puncture site. Then, guided by a guidewire, the balloon is gradually advanced along the vascular path to the target lesion. However, before reaching the lesion, the narrowed areas and areas of tissue hyperplasia within the blood vessel significantly hinder balloon advancement. The stenotic segment drastically reduces the vessel diameter, while tissue hyperplasia causes uneven vessel walls and highly irregular lumen morphology. This not only greatly increases the frictional force on the balloon's movement but also causes deviations in its direction of travel, making it difficult to reach the target location smoothly along the predetermined path, posing numerous challenges to the successful execution of the procedure.

[0004] Under current technological conditions, to effectively address the challenge of balloon delivery being difficult due to narrowed blood vessels, the industry generally adopts the following strategies: First, during balloon advancement, the surgeon must maintain a gentle and slow operating rhythm throughout the entire process. The vessel walls in the narrowed segment are fragile, and tissue proliferation makes the lumen's morphology intricate. Even slight carelessness, such as excessive force, can damage the vessel wall, potentially causing rupture and uncontrollable massive bleeding, which can be life-threatening. Furthermore, if the balloon becomes stuck in the narrowed area, it will directly interrupt the surgical procedure, causing acute vascular occlusion. Therefore, surgeons often employ a segmented advancement method. After each small step, they use high-precision imaging equipment such as angiography and intravascular ultrasound to comprehensively and meticulously confirm the balloon's position and the real-time condition of the vessel, ensuring the balloon progresses steadily along the predetermined path and reducing surgical risks.

[0005] Secondly, when the balloon encounters resistance during its advancement, the doctor will gently rotate the balloon catheter to flexibly change the contact angle between the balloon and the narrowed area or the area of ​​tissue proliferation. With rich clinical experience, the doctor can keenly observe the subtle differences in the local vascular structure and find the best angle to break through, helping the balloon to pass smoothly through the obstruction area.

[0006] However, both of these methods place extremely high demands on the doctor's professional competence. They require not only solid anatomical knowledge, rich clinical experience, and superb operational skills, but also excellent hand-eye coordination and spatial awareness. Any slight error could lead to balloon delivery failure, or even irreversible and serious consequences for the patient. Overall, this approach, heavily reliant on the doctor's personal experience and operational skills, is extremely difficult to implement in practice, facing the dilemma of low practicality and limited scalability when widely adopted in clinical settings. Utility Model Content

[0007] The purpose of this invention is to provide a balloon-type drug delivery device for the treatment of arteriovenous fistula stenosis, aiming to solve the technical problems in the background art.

[0008] The embodiments of this utility model are implemented as follows: This application provides a balloon-type drug delivery device for treating arteriovenous fistula stenosis, comprising: a guide connecting post having a first channel, a second channel, a third channel, and a fourth channel axially arranged; the first channel being located at the center of the guide connecting post and penetrating through the two end faces of the guide connecting post to form an inlet and an outlet; the second, third, and fourth channels being located on the outer periphery of the first channel and arranged sequentially at intervals along the circumferential direction of the first channel; wherein the second, third, and fourth channels are each independently connected to an injection channel near the inlet; an expansion balloon being sleeved on the guide connecting post near the outlet and communicating with the second channel; a drug delivery balloon including a first balloon and a second balloon; the first balloon being sleeved on the guide connecting post and located between the expansion balloon and the inlet; the first balloon communicating with the third channel; the second balloon being sleeved on the first balloon and communicating with the fourth channel; and a microneedle structure being disposed on the outer surface of the second balloon and communicating with the inner cavity of the second balloon.

[0009] Furthermore, based on the aforementioned scheme, a substrate is provided on the outer side of the second balloon, the microneedle structure is disposed on the substrate, and the substrate is provided with a through hole connecting the microneedle structure and the inner cavity of the second balloon; wherein, the number of the microneedle structures on the substrate is multiple.

[0010] Furthermore, based on the aforementioned scheme, the second balloon includes a first state and a second state. When the second balloon is in the first state, it is folded and covers the microneedle structure. When the second balloon is in the second state, it expands and causes the microneedle structure to protrude from the second balloon.

[0011] Furthermore, based on the aforementioned scheme, each of the above-mentioned injection channels is equipped with a valve.

[0012] Furthermore, based on the aforementioned scheme, it also includes a catheter, which is inserted through the first channel and can be detachably coupled with the first channel.

[0013] Furthermore, based on the aforementioned scheme, the aforementioned expansion balloon is annular, and forms a first injection cavity with the outer annular surface of the aforementioned guide connecting column; The guide connecting post is provided with a first drain port that connects the second channel and the first injection chamber.

[0014] Furthermore, based on the aforementioned scheme, both the first balloon and the second balloon are annular, the outer annular surface of the first balloon and the guide connecting post form a second injection cavity, and the guide connecting post is provided with a second drain port that connects the third channel and the second injection cavity; The second balloon is sleeved on the guide connecting post, the first balloon is located inside the second balloon, the first balloon, the second balloon and the guide connecting post together constitute a drug cavity, and the guide connecting post is provided with a third drainage port that connects the fourth channel and the drug cavity.

[0015] Compared with the prior art, the embodiments of this utility model have at least the following advantages or beneficial effects: The drug delivery device provided in this application, in actual operation, first inserts a catheter into the first channel of the guide connecting post, and then allows the catheter to exit from the outlet. A guidewire is then inserted into the catheter. Guided by the guidewire, the device can smoothly reach the vascular lesion site. When the device encounters an obstruction during its advancement, the inflatable balloon will first contact the obstruction. At this time, a medium is injected into the inflatable balloon through the second channel, causing the balloon to deform and adjust, effectively widening the space at the obstruction site and creating favorable conditions for the smooth passage of the drug delivery balloon. After the drug delivery balloon successfully reaches the lesion site, the therapeutic drug is injected into the second balloon through the third channel, followed by the injection of a medium into the first balloon through the fourth channel. After the first balloon inflates, the microneedle structure attached to the outer surface of the second balloon pierces the vascular lesion. Simultaneously, the expansion of the first balloon exerts a squeezing effect on the second balloon, causing the drug inside the second balloon to be injected into the lesion tissue through the microneedle structure. This design has significant advantages. The pre-expansion balloon clears the narrowed area, effectively reducing the resistance to pushing the drug delivery balloon and greatly minimizing the risk of vascular damage or balloon jamming due to improper operation by the physician, thus significantly improving the success rate of the procedure. Compared with traditional techniques, this device significantly improves the problems of poor practicality and scalability in clinical applications, providing a safe, efficient, and easily promoted new solution for vascular interventional therapy. Attached Figure Description

[0016] To more clearly illustrate the technical solutions of the embodiments of this utility model, the drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this utility model and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0017] Figure 1 This is a front view of a balloon-type drug delivery device for treating arteriovenous fistula stenosis according to an embodiment of the present invention; Figure 2 This is a partial cross-sectional view of a balloon-type drug delivery device for treating arteriovenous fistula stenosis according to an embodiment of the present invention; Figure 3 This is a cross-sectional view of the guide connecting column in an embodiment of the present invention; Figure 4 for Figure 1 A cross-sectional view along the AA direction; Figure 5 for Figure 2 A magnified view of part B in the image; Figure 6 for Figure 2 A magnified view of part C; Figure 7 for Figure 2 A magnified view of part D; Figure 8 This is a side view of the second balloon in the first state according to an embodiment of the present invention.

[0018] Icons: 1-Catheter, 2-Dilution balloon, 3-Guide connecting post, 301-First channel, 302-Second channel, 303-Third channel, 304-Fourth channel, 4-First balloon, 5-Second balloon, 6-Injection channel, 7-Valve, 8-First injection chamber, 9-Second injection chamber, 10-Drug chamber, 11-First drainage port, 12-Base plate, 13-Microneedle structure, 14-Second drainage port, 15-Third drainage port. Detailed Implementation

[0019] The embodiments of this application will now be described in detail with reference to the accompanying drawings. Example

[0020] Please refer to Figures 1-3 This application provides a balloon-type drug delivery device for treating arteriovenous fistula stenosis, comprising: a guide connecting post 3, axially arranged with a first channel 301, a second channel 302, a third channel 303, and a fourth channel 304. The first channel 301 is located at the center of the guide connecting post 3, and its two ends respectively penetrate the two end faces of the guide connecting post 3 to form an inlet and an outlet. The second channel 302, the third channel 303, and the fourth channel 304 are all located on the outer periphery of the first channel 301, and are arranged sequentially at intervals along the circumferential direction of the first channel 301. 04. An injection channel 6 is independently connected to each of the above-mentioned inlets; an expansion balloon 2 is sleeved on the above-mentioned guide connecting post 3 near the above-mentioned outlet and is connected to the above-mentioned second channel 302; a drug delivery balloon includes a first balloon 4 and a second balloon 5, the first balloon 4 is sleeved on the above-mentioned guide connecting post 3 and is located between the above-mentioned expansion balloon 2 and the above-mentioned inlet, the first balloon 4 is connected to the above-mentioned third channel 303, the second balloon 5 is sleeved on the first balloon 4 and is connected to the above-mentioned fourth channel 304; and a microneedle structure 13 is disposed on the outer surface of the second balloon 5 and is connected to the inner cavity of the second balloon 5.

[0021] The drug delivery device provided in this application, in actual operation, first inserts the catheter 1 into the first channel 301 of the guide connecting post 3, and then allows the catheter 1 to exit from the outlet. A guidewire is then inserted into the catheter 1. Guided by the guidewire, the device can smoothly reach the vascular lesion site. When the device encounters an obstruction during its advancement, the expansion balloon 2 will first contact the obstruction site. At this time, a medium is injected into the expansion balloon 2 through the second channel 302, causing the balloon to deform and adjust, effectively widening the space at the obstruction site and creating favorable conditions for the smooth passage of the drug delivery balloon. After the drug delivery balloon successfully reaches the lesion site, the therapeutic drug is injected into the second balloon 5 through the third channel 303, followed by the injection of a medium into the first balloon 4 through the fourth channel 304. After the first balloon 4 inflates, the microneedle structure 13 attached to the outer surface of the second balloon 5 will pierce the vascular lesion site. Simultaneously, the expansion of the first balloon 4 will exert a squeezing effect on the second balloon 5, causing the drug inside the second balloon 5 to be injected into the lesion tissue through the microneedle structure 13. This design has significant advantages. The dilatation balloon 2 pre-treats the narrowed area, effectively reducing the resistance to pushing the drug delivery balloon and greatly minimizing the risk of vascular damage or balloon jamming due to improper physician operation, thus significantly improving the success rate of the procedure. Compared with traditional techniques, this device significantly improves the problems of poor practicality and scalability in clinical applications, providing a safe, efficient, and easily promoted new solution for vascular interventional therapy.

[0022] Specifically, the first balloon 4 is a semi-compliant or compliant balloon, and the second balloon 5 is a non-compliant balloon. The drug delivery design of the first balloon 4, the second balloon 5, and the microneedle structure 13 is a conventional technique in the field and will not be described in detail here. Example

[0023] Please refer to Figure 5 This embodiment is the same as the embodiment 1 in terms of main body, the main difference being that the outer side of the second balloon 5 is provided with a substrate 12, the microneedle structure 13 is provided on the substrate 12, and the substrate 12 is provided with a through hole connecting the microneedle structure 13 and the inner cavity of the second balloon 5; wherein, the number of the microneedle structures 13 on the substrate 12 is multiple.

[0024] In the above embodiments, the presence of the substrate 12 provides a stable support platform for the microneedle structure 13, preventing the microneedles from shaking or falling off during use, thus greatly improving the stability and reliability of the microneedles. Multiple microneedle structures 13 can simultaneously inject drugs into the lesion site at multiple points, which not only accelerates the drug delivery speed but also allows the drug to be evenly distributed in the lesion area, significantly enhancing the therapeutic effect.

[0025] Please refer to Figure 8In a preferred embodiment, the second balloon 5 includes a first state and a second state. When the second balloon 5 is in the first state, it is folded and covers the microneedle structure 13. When the second balloon 5 is in the second state, it expands and causes the microneedle structure 13 to protrude from the second balloon 5.

[0026] In the above embodiments, in the first state, the second balloon 5 is folded, completely covering the microneedle structure 13. This prevents the microneedle from accidentally contacting the blood vessel wall during device delivery, effectively reducing the risk of blood vessel scratches and perforation, and ensuring the safety of the delivery process. When the second balloon 5 reaches the lesion site, enters the second state, and begins to inflate, the microneedle structure 13 protrudes from the balloon surface, allowing the microneedle to precisely pierce the lesion tissue. This design not only ensures that the microneedle plays its role in key treatment stages but also achieves targeted drug delivery, improving treatment efficacy, reducing the impact of drugs on healthy tissue, and lowering the probability of complications.

[0027] Please refer to Figure 1 As a preferred embodiment, any of the above-mentioned injection channels 6 is provided with a valve 7.

[0028] In the above embodiments, valve 7 can precisely control the injection of media and drugs, allowing doctors to flexibly determine the timing, speed, and dosage of injection based on the actual surgical situation, significantly improving the accuracy of treatment. Furthermore, during non-injection phases, valve 7 is in a closed state, effectively preventing backflow of media and drugs, avoiding unnecessary impact on other tissues, and ensuring the stability of the surgical environment.

[0029] Please refer to Figure 1 In a preferred embodiment, the device also includes a conduit 1, which is inserted through the first channel 301 and is detachably coupled with the first channel 301.

[0030] In the above embodiments, during preoperative preparation and surgical procedures, catheter 1 can be flexibly and conveniently inserted into the first channel 301, providing a stable guidewire introduction route for the device, which then smoothly reaches the vascular lesion site with the help of the guidewire. Furthermore, once the device reaches the designated position, catheter 1 can be easily detached from the first channel 301. This design avoids catheter 1 causing obstruction in subsequent treatment procedures, allowing doctors to more freely manipulate the balloon for dilation, drug administration, and other operations, reducing the difficulty of the surgery. Example

[0031] Please refer to Figure 4 This embodiment is the same as the embodiment 1 in terms of main body, the main difference being that the above-mentioned expansion balloon 2 is annular, and forms a first injection cavity 8 with the outer ring surface of the above-mentioned guide connecting column 3; The guide connecting post 3 is provided with a first drain port 11 that connects the second channel 302 and the first injection chamber 8.

[0032] In the above embodiments, the annular dilation balloon 2, when inflated, can apply force evenly around the narrowed area of ​​the blood vessel, avoiding uneven local force that could lead to vascular damage, and allowing the narrowed area to dilate more evenly and effectively. The presence of the first injection chamber 8 provides ample storage and operating space for the medium, ensuring that the dilation balloon 2 can stably and efficiently perform its dilation function. The design of the first drainage port 11 establishes a stable medium transmission path between the second channel 302 and the first injection chamber 8. When the doctor injects the medium through the second channel 302, the medium can flow quickly and smoothly into the first injection chamber 8, pushing the dilation balloon 2 to inflate in time, greatly improving the response speed and ease of operation of the device, and providing strong support for the smooth conduct of the surgery.

[0033] Please refer to Figure 6 and Figure 7 In a preferred embodiment, both the first balloon 4 and the second balloon 5 are annular. The outer annular surface of the first balloon 4 and the guide connecting post 3 forms a second injection cavity 9. The guide connecting post 3 is provided with a second drainage port 14 that connects the third channel 303 and the second injection cavity 9. The second balloon 5 is sleeved on the guide connecting post 3, and the first balloon 4 is located inside the second balloon 5. The first balloon 4, the second balloon 5, and the guide connecting post 3 together form a drug cavity 10. The guide connecting post 3 is provided with a third drainage port 15 that connects the fourth channel 304 and the drug cavity 10.

[0034] In the above embodiments, the annular first balloon 4 and second balloon 5 can apply force evenly along the circumference of the blood vessel wall when inflated. This not only ensures uniform force at the vascular lesion site, reducing the risk of blood vessel rupture due to excessive local pressure, but also achieves balanced drug distribution around the blood vessel wall, improving the therapeutic effect. The second injection chamber 9 and the second drainage port 14 allow the medium injected through the third channel 303 to flow in quickly and accurately, promoting stable inflation of the first balloon 4 and ensuring accurate insertion of the microneedle into the lesion tissue. At the same time, the third drainage port 15 connects the fourth channel 304 and the drug chamber 10, facilitating the flow of the drug injected through the fourth channel 304 into the drug chamber 10, and then injecting it into the lesion site through the microneedle structure 13, achieving targeted drug delivery.

[0035] Furthermore, unless otherwise explicitly specified or limited, the terms "installation" and "connection" in this application embodiment should be interpreted broadly. For example, "connection" can be a detachable connection or a non-detachable connection; it can be a direct connection or an indirect connection through an intermediate medium. The terms "upper," "lower," "left," "right," "inner," "outer," and "side," etc., are merely for reference to the direction in the accompanying drawings or the usual placement of the product during use. They are only for clearly describing this application and do not indicate or imply that the device or component referred to must have a specific orientation, or be constructed and operated in a specific orientation. They should not be construed as limitations on this application. The terms "first," "second," etc., are only used for distinguishing descriptions and should not be construed as indicating or implying relative importance; "multiple" refers to at least two. In this application embodiment, the limitations on relative positional relationships such as parallel, perpendicular, and aligned are all relative to the current technological level and are not absolutely strict limitations. Slight deviations are allowed; approximations of parallel, perpendicular, and aligned are all acceptable. For example, "A and B are parallel" means that A and B are parallel or approximately parallel, and the angle between A and B can be between 0 degrees and 10 degrees.

[0036] The above are only some embodiments and implementation methods of this application. The protection scope of this application is not limited thereto. In the absence of conflict, the embodiments and features in the embodiments of this application can be combined with each other. Any combination of features in different embodiments is also within the protection scope of this application. Any changes or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application should be included within the protection scope of this application.

Claims

1. A balloon-type drug delivery device for treating arteriovenous fistula stenosis, characterized in that, include: The guide connecting post (3) is axially provided with a first channel (301), a second channel (302), a third channel (303) and a fourth channel (304). The first channel (301) is located at the center of the guide connecting post (3) and its two ends pass through the two end faces of the guide connecting post (3) to form an inlet and an outlet. The second channel (302), the third channel (303) and the fourth channel (304) are all located on the outer periphery of the first channel (301) and are arranged sequentially at intervals along the circumferential direction of the first channel (301). Among them, the second channel (302), the third channel (303) and the fourth channel (304) are each independently connected to an injection channel (6) near the inlet; An inflatable balloon (2) is fitted onto the guide connecting post (3) near the outlet and communicates with the second channel (302); The drug delivery balloon includes a first balloon (4) and a second balloon (5). The first balloon (4) is fitted onto the guide connecting post (3) and is located between the dilation balloon (2) and the inlet. The first balloon (4) communicates with the third channel (303). The second balloon (5) is fitted onto the first balloon (4) and communicates with the fourth channel (304). The microneedle structure (13) is disposed on the outer side of the second balloon (5) and communicates with the inner cavity of the second balloon (5).

2. The balloon-type drug delivery device for treating arteriovenous fistula stenosis according to claim 1, characterized in that, The outer side of the second balloon (5) is provided with a substrate (12), the microneedle structure (13) is disposed on the substrate (12), and the substrate (12) is provided with a through hole connecting the microneedle structure (13) and the inner cavity of the second balloon (5); The number of microneedle structures (13) on the substrate (12) is multiple.

3. A balloon-type drug delivery device for treating arteriovenous fistula stenosis according to claim 1, characterized in that, The second balloon (5) includes a first state and a second state. When the second balloon (5) is in the first state, the second balloon (5) is in a folded state and covers the microneedle structure (13). When the second balloon (5) is in the second state, the second balloon (5) inflates and causes the microneedle structure (13) to protrude from the second balloon (5).

4. A balloon-type drug delivery device for treating arteriovenous fistula stenosis according to claim 1, characterized in that, Each of the injection channels (6) is provided with a valve (7).

5. A balloon-type drug delivery device for treating arteriovenous fistula stenosis according to claim 1, characterized in that, It also includes a conduit (1) that passes through the first channel (301) and is detachably coupled with the first channel (301).

6. A balloon-type drug delivery device for treating arteriovenous fistula stenosis according to claim 1, characterized in that, The expansion balloon (2) is annular and forms a first injection cavity (8) with the outer annular surface of the guide connecting post (3); The guide connecting post (3) is provided with a first drain port (11) that connects the second channel (302) and the first injection chamber (8).

7. A balloon-type drug delivery device for treating arteriovenous fistula stenosis according to claim 6, characterized in that, Both the first balloon (4) and the second balloon (5) are annular. The first balloon (4) and the outer ring surface of the guide connecting post (3) form a second injection cavity (9). The guide connecting post (3) is provided with a second drainage port (14) that connects the third channel (303) and the second injection cavity (9). The second balloon (5) is sleeved on the guide connecting post (3), the first balloon (4) is located inside the second balloon (5), the first balloon (4), the second balloon (5) and the guide connecting post (3) together form a drug cavity (10), and the guide connecting post (3) is provided with a third drainage port (15) connecting the fourth channel (304) and the drug cavity (10).

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