Special-shaped medicine balloon dilatation catheter

By incorporating an annular anti-slip element and a drug-coated irregularly shaped drug-eluting balloon dilatation catheter, the problems of balloon slippage and dilatation failure have been solved, resulting in better dilation and therapeutic effects.

CN223569827UActive Publication Date: 2025-11-21成都纽创医疗器械有限公司
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Patent Information

Application Number
CN202422377108.4
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2024-09-27
Publication Date
2025-11-21
Estimated Expiration
2034-09-27

AI Technical Summary

Technical Problem

Existing balloon dilation catheters are prone to slippage during dilation, leading to dilation failure, especially when the lesion site is hard and difficult to dilate effectively.

Method used

A novel drug-eluting balloon dilation catheter was designed, with an annular anti-slip element on the balloon to increase friction with the lesion site, and a drug coating to enhance the therapeutic effect.

Benefits of technology

It effectively avoids slippage, ensures effective balloon expansion at the lesion site, and improves treatment efficacy through direct contact with the lesion site via the drug coating.

✦ Generated by Eureka AI based on patent content.

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Abstract

The embodiment of the utility model provides a special-shaped medicine balloon dilatation catheter, and relates to the technical field of balloon catheters. The special-shaped drug balloon dilatation catheter comprises a catheter body and a drug balloon, the drug balloon is provided with a drug coating, the drug balloon is arranged on the catheter body, the drug balloon is provided with an annular anti-skid piece, and the annular anti-skid piece surrounds the axis of the drug balloon. Due to the fact that the medicine balloon is provided with the annular anti-skid piece, the friction force between the medicine balloon and the diseased region can be increased when the medicine balloon passes through the narrow portion, the slipping phenomenon of the medicine balloon is avoided, then the situation of expansion failure is avoided, the pressure intensity of contact between the medicine balloon and the diseased region can be increased at the seriously hardened portion, and the better expansion effect is achieved. Meanwhile, the surface of the drug balloon is coated with the lipophilic drug coating, after the drug balloon is expanded, the drug can be better released to the diseased region, and a more excellent treatment effect is achieved.
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Description

TECHNICAL FIELD

[0001] The utility model relates to the technical field of balloon catheter, specifically, a special-shaped medicine balloon dilatation catheter. BACKGROUND

[0002] In the prior art, the balloon of the balloon dilatation catheter will have a slippage phenomenon during expansion, that is, it will be displaced towards the proximal end or distal end of the lesion, resulting in expansion failure, which is referred to as the "watermelon seed effect". Although it can be prevented by slowly pressurizing the balloon and applying a counterforce to the balloon rod in the slippage direction, the effect is not ideal. SUMMARY

[0003] The utility model provides a special-shaped medicine balloon dilatation catheter, which can avoid the slippage phenomenon of the medicine balloon, thereby avoiding the expansion failure. At the same time, the medicine balloon has a drug coating, and after the medicine balloon is expanded, the drug directly contacts the lesion site, achieving better treatment effect.

[0004] The embodiments of the utility model can be implemented as follows:

[0005] The utility model provides a special-shaped medicine balloon dilatation catheter, which can avoid the slippage phenomenon of the medicine balloon, thereby avoiding the expansion failure. At the same time, the medicine balloon has a drug coating, and after the medicine balloon is expanded, the drug directly contacts the lesion site, achieving better treatment effect.

[0006] The catheter body; and

[0007] The medicine balloon has a drug coating, and the medicine balloon is provided on the catheter body, and the medicine balloon has an annular anti-skid member which surrounds the axis of the medicine balloon.

[0008] In an optional embodiment, part of the circumferential wall of the medicine balloon is raised to form the annular anti-skid member.

[0009] In an optional embodiment, the medicine balloon comprises a balloon body and an annular anti-skid member, the balloon body is provided on the catheter body, and the annular anti-skid member is provided on the circumferential wall of the balloon body and surrounds the axis of the balloon body.

[0010] In an optional embodiment, the number of annular anti-skid members is multiple, and the multiple annular anti-skid members are distributed at intervals.

[0011] In an optional embodiment, the catheter body comprises a tube body and a push rod, the tube body and the push rod are connected, the tube body comprises an inner catheter and an outer catheter, the outer catheter is sleeved outside the inner catheter, the medicine balloon is provided at the distal end of the inner catheter, and the annular anti-skid member surrounds the inner catheter.

[0012] In an alternative embodiment, the outer catheter is provided with a rapid exchange port, and the proximal end of the inner catheter is connected to the rapid exchange port.

[0013] In an alternative embodiment, the tube body further comprises a catheter tip, and the catheter tip is connected to the distal end of the inner catheter.

[0014] In an alternative embodiment, the heteromorphic drug balloon dilatation catheter further comprises a first imaging marker and a second imaging marker, and the first imaging marker and the second imaging marker are arranged at intervals on the inner catheter.

[0015] In an alternative embodiment, the catheter body further comprises a catheter seat, and the catheter seat is connected to the proximal end of the push rod.

[0016] In an alternative embodiment, the drug coating is a lipophilic drug coating.

[0017] The beneficial effects of the heteromorphic drug balloon dilatation catheter of the embodiments of the present application include, for example:

[0018] The present application provides a heteromorphic drug balloon dilatation catheter, which comprises a catheter body and a drug balloon, the drug balloon has a drug coating, the drug balloon is arranged on the catheter body, the drug balloon has an annular anti-skid member, and the annular anti-skid member surrounds the axis of the drug balloon. Since the drug balloon has the annular anti-skid member, the friction between the balloon and the lesion site can be increased when passing through a narrow place, the balloon can be prevented from slipping, and the expansion failure can be avoided. In addition, the pressure of the lesion site contacted by the balloon can be increased in a hardened serious part, so that the balloon can be expanded better. At the same time, the drug balloon has a drug coating, and the drug directly contacts the lesion site through the expansion of the drug balloon, so that the treatment effect is more excellent. BRIEF DESCRIPTION OF DRAWINGS

[0019] In order to more clearly illustrate the technical scheme of the embodiments of the present application, the following will briefly introduce the drawings needed to be used in the embodiments. It should be understood that the following drawings only show some embodiments of the present application, and therefore should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can also be obtained without creative labor on the basis of these drawings.

[0020] Figure 1 FIG. 1 is a schematic view of a heteromorphic drug balloon dilatation catheter provided in an embodiment of the present application;

[0021] Figure 2 FIG. 2 is a partial schematic view of a heteromorphic drug balloon dilatation catheter provided in an embodiment of the present application.

[0022] Icon: 1000 - Shaped drug balloon dilatation catheter; 100 - Catheter body; 110 - Tube body; 111 - Inner catheter; 112 - Outer catheter; 1121 - Quick exchange port; 113 - Catheter tip; 120 - Pushing rod; 200 - Drug balloon; 210 - Annular anti-skid piece; 310 - First imaging marker; 320 - Second imaging marker; 400 - Catheter seat. DETAILED DESCRIPTION

[0023] In order to make the purpose, technical scheme and advantages of the embodiments of the present application clearer, the technical scheme in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. The components of the embodiments of the present application described and shown in the drawings can be arranged and designed in various different configurations.

[0024] Therefore, the following detailed description of the embodiments of the present application provided in the drawings is not intended to limit the scope of the claimed present application, but only represents selected embodiments of the present application. All other embodiments obtained by those of ordinary skill in the art based on the embodiments in the present application without creative labor are within the scope of protection of the present application.

[0025] It should be noted that: similar reference numbers and letters represent similar items in the following drawings, therefore, once an item is defined in one drawing, it does not need to be further defined and explained in subsequent drawings.

[0026] In the description of the present application, it should be noted that if the terms "upper", "lower", "inner", "outer" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship when the product of the present application is usually placed, which is only for the convenience of describing the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the indicated device or element must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application.

[0027] In addition, if the terms "first", "second" and the like appear, they are only used for differentiation in description, and cannot be understood as indicating or implying relative importance.

[0028] It should be noted that the features in the embodiments of the present application can be combined with each other without conflict.

[0029] The demand for medical devices for treating cardiovascular diseases, including cerebrovascular diseases, is extremely large. At present, intravascular balloon dilatation and stent implantation are mainly used to treat intravascular stenosis and occlusion lesions.

[0030] Balloon is one of the first treatment devices that neurointerventionists contact. Although the previous balloon has a high frequency, its application scenario is limited: mainly used for expanding stenosis. In 2015, the thrombectomy treatment of acute large vessel occlusion caused by ischemic stroke was highly recommended by global guidelines, and this treatment was quickly popularized. Because thrombectomy needs to quickly open the blood vessel under complex and unknown blood vessel conditions, while minimizing complications, the application scenario of the balloon has been greatly expanded.

[0031] Nowadays, the balloon catheter technology trends are divided into two directions: one is the improvement of the materials and processes of each component of the balloon catheter, such as high toughness and high pressure-resistant materials are applied to manufacture the balloon, and various metal push rods are used to enhance the overall performance of the catheter.

[0032] The second is to add drugs or components to the surface of the balloon to achieve a breakthrough in the function of the balloon, such as drug-coated balloons, scored balloons, cutting balloons, spines balloons, and shock wave balloons. Among them, the drug-coated balloon is a new type of interventional treatment device popularized in recent years, which is to coat the anti-vascular intimal hyperplasia drug on the surface of the balloon. In the process of arterial stenosis interventional treatment, first, use the ordinary balloon to fully expand the blood vessel, and then use the drug-coated balloon to pressurize and quickly release the drug at the expanded blood vessel stenosis site, release the loaded anti-cell proliferation drug to the blood vessel wall through the tearing of the lesion vascular intima, and be quickly absorbed by the blood vessel wall tissue to achieve the effect of inhibiting vascular intimal hyperplasia, thereby preventing the restenosis of the lesion blood vessel after the vascular interventional treatment. After completing the local drug delivery, the balloon is removed from the body, and there is no implant in the body.

[0033] The manufacturing processes of the above two directions of the balloon tend to be mature, and the use of balloon dilation in the interventional field is also increasingly widespread, but there are still many problems in the actual use of the balloon to dilate the lesion of the blood vessel by the operator, such as the slipping phenomenon, and the hard-to-dilate part of the lesion.

[0034] As mentioned in the background, in the prior art, the balloon of the balloon dilation catheter will slip during the expansion process, that is, it will move to the proximal or distal end of the lesion, resulting in expansion failure, which is called the "watermelon seed effect". Although it can be prevented by slowly pressurizing the balloon and applying a counterforce to the balloon rod in the direction of slipping, the effect is not ideal.

[0035] In addition, part of the lesion is hard to dilate and needs to be pretreated with a special balloon.

[0036] In view of this, please refer to Figure 1 and Figure 2 The special-shaped drug-coated balloon dilation catheter 1000 provided in the embodiments of the present application can solve this problem, which will be described in detail as follows.

[0037] The embodiment of the utility model provides a kind of special-shaped medicine balloon dilatation catheter 1000, the special-shaped medicine balloon dilatation catheter 1000 includes catheter body 100 and medicine balloon 200, medicine balloon 200 has medicine coating (i.e.

[0038] Since medicine balloon 200 has annular anti-skid piece 210, it can increase the friction between medicine balloon 200 and the lesion site when passing through the narrow place, avoid the phenomenon of medicine balloon 200 slipping, and further avoid the situation of expansion failure, while the pressure of contact with the lesion site can also be increased at the severely hardened site, better expansion effect is achieved, to solve the situation that part of lesion is hard to expand.

[0039] It should be noted that in the present application, the terms "proximal end" and "distal end" are conventional terms in the medical field, specifically, "distal end" means the end far from the operator during the operation, and "proximal end" means the end close to the operator during the operation.

[0040] The medicine coating can be understood as a lipophilic medicine coating.

[0041] Specifically, the number of annular anti-skid pieces 210 can be multiple, and the multiple annular anti-skid pieces 210 are distributed at intervals, where multiple can be understood as at least two, in the embodiment, the number of annular anti-skid pieces 210 is two, and the two annular anti-skid pieces 210 are distributed at intervals, of course, in other embodiments, the number of annular anti-skid pieces 210 can also be three, four or five, etc.

[0042] The number of annular anti-skid pieces 210 can be increased or decreased according to the actual length of medicine balloon 200 or use demand, for example, a special-shaped medicine balloon dilatation catheter 1000 with different numbers of annular anti-skid pieces 210 can be designed to meet the rich selection to cope with different sizes of lesion blood vessels.

[0043] For example, the longer the length of medicine balloon 200 is, the more the number of annular anti-skid pieces 210 can be, where the length of medicine balloon 200 can be understood as the length dimension of medicine balloon 200 along the axis direction of medicine balloon 200.

[0044] In addition, it should be noted that in the present embodiment, the partial circumferential wall of the drug balloon 200 is protruded to form the annular anti-skid member 210, the height of the annular anti-skid member 210 can be 0.17-0.23mm, for example, the height of the annular anti-skid member 210 can be 0.2mm, here, the height of the annular anti-skid member 210 can be understood as the height dimension of the protrusion of the partial circumferential wall of the drug balloon 200, that is, along the radial direction of the drug balloon 200, the length dimension of the annular anti-skid member 210 protruding relative to the remaining circumferential wall of the drug balloon 200.

[0045] In the present embodiment, the drug balloon 200 can be made of nylon material, the entire drug balloon 200 can be integrally formed, and the annular anti-skid member 210 can be understood as the protrusion of the partial circumferential inner wall of the drug balloon 200 towards the partial circumferential outer wall, at this time, the inner wall of the drug balloon 200 at the position of the annular anti-skid member 210 is equivalent to an annular groove.

[0046] It should be noted that in other embodiments, the drug balloon 200 can also include a balloon body (which can be understood as Figure 2 the part of the drug balloon 200 except the annular anti-skid member 210) and the annular anti-skid member 210, the balloon body is arranged in the inner catheter 111 of the catheter body 100, the annular anti-skid member 210 is arranged on the circumferential wall of the balloon body, and the annular anti-skid member 210 surrounds the axis of the balloon body.

[0047] The balloon body and the annular anti-skid member 210 can be integrally formed, or the annular anti-skid member 210 can be sleeved on the outer wall of the balloon body, the annular anti-skid member 210 can be similar to a swimming ring structure, and the height of the annular anti-skid member 210 can be 0.2mm, here, the height of the annular anti-skid member 210 can be understood as the length dimension of the annular anti-skid member 210 protruding relative to the outer wall of the balloon body along the radial direction of the balloon body.

[0048] It is easy to understand that the surface of the drug balloon 200 has a drug coating, which is equivalent to part of the drug coating being located on the outer wall of the annular anti-skid member 210 and part of the drug coating being located on the partial outer wall of the balloon body.

[0049] Through the cooperation of the drug coating, the special-shaped drug balloon dilation catheter 1000 can achieve better therapeutic effect.

[0050] In addition, it should be noted that in the present embodiment, the catheter body 100 includes a tube 110 and a push rod 120, the tube 110 and the push rod 120 are connected, the tube 110 includes an inner catheter 111 and an outer catheter 112, the outer catheter 112 is sleeved on the outer side of the inner catheter 111, the drug balloon 200 is arranged at the distal end of the inner catheter 111, and the annular anti-skid member 210 surrounds the inner catheter 111.

[0051] Specifically, the proximal end of the drug balloon 200 is connected with the outer catheter 112.

[0052] The outer catheter 112 is provided with a rapid exchange port 1121, and the proximal end of the inner catheter 111 is connected with the rapid exchange port 1121. In addition, the catheter body 110 further comprises a catheter tip 113, the catheter tip 113 is connected with the distal end of the inner catheter 111, and the distal end of the drug balloon 200 can be connected with the catheter tip 113.

[0053] The special-shaped drug balloon expansion catheter 1000 further comprises a first imaging marker 310 and a second imaging marker 320, and the first imaging marker 310 and the second imaging marker 320 are arranged at intervals on the inner catheter 111.

[0054] The catheter body 100 further comprises a catheter seat 400, and the catheter seat 400 is connected with the end of the push rod 120 away from the catheter body 110. Specifically, the catheter seat 400 can be connected with the proximal end of the push rod 120.

[0055] In addition, it should be noted that in the process of manufacturing the special-shaped drug balloon expansion catheter 1000, generally, the catheter tip 113 can be first fixed in length, and the fixed-length catheter tip 113 is welded with the inner tube to form a tip welding assembly by welding technology, then the first imaging marker 310 and the second imaging marker 320 are pressed on the inner tube of the tip welding assembly in sequence to form an imaging ring pressing assembly by pressing technology, then the proximal end of the drug balloon 200 is welded with an outer tube to form a proximal end welding assembly by laser welding technology, then the balloon distal end tube foot part of the welded proximal end welding assembly is welded with the tip tube and the inner tube connection part of the imaging ring pressing assembly to form a distal end welding assembly, then a section of outer tube is cut off, and the outer tube is welded with the outer tube of the distal end welding assembly by welding (at this time, the above-mentioned outer catheter 112 is manufactured), the part of the inner tube extending out of the connection part of the two outer tubes is cut off (at this time, the above-mentioned inner catheter 111 is manufactured) to obtain a rapid exchange port assembly, then the proximal end outer tube part of the welded rapid exchange port assembly is welded with the metal push rod 120 connected with the catheter seat 400, and finally the drug balloon 200 spraying technology is used to make the drug evenly adhere to the outer wall of the drug balloon 200 to form a drug coating, thereby completing the manufacturing of the special-shaped drug balloon expansion catheter 1000 provided in the embodiment.

[0056] In summary, the special-shaped drug balloon expansion catheter 1000 comprises a catheter body 100 and a drug balloon 200, the drug balloon 200 is arranged on the catheter body 100, the drug balloon 200 is arranged on the catheter body 100, the drug balloon 200 has an annular anti-skid piece 210, the annular anti-skid piece 210 is wrapped around the axis of the drug balloon 200, because the drug balloon 200 has the annular anti-skid piece 210, the friction between the drug balloon 200 and the lesion site can be increased when passing through the stenosis, the phenomenon of slipping of the drug balloon 200 is avoided, and the expansion failure is avoided, and meanwhile, the pressure of the contact between the drug balloon 200 and the lesion site can be increased at the serious hardening site, and better expansion effect is achieved. Meanwhile, the drug balloon 200 has a drug coating, the drug is directly contacted with the lesion site through the expansion of the drug balloon 200, and the treatment effect is more excellent.

[0057] The special-shaped drug balloon expansion catheter 1000 solves the problem of the slipping of the drug balloon 200 in the process of treating the intravascular stenosis lesion by using the drug balloon expansion technique through the improvement of the shape of the drug balloon 200 and the combination of the drug coating, and the use of the drug coating can achieve better treatment effect.

[0058] In addition, the number of the annular anti-skid pieces 210 can be multiple, the multiple annular anti-skid pieces 210 are distributed at intervals, the number of the annular anti-skid pieces 210 can be increased or decreased according to the actual length of the drug balloon 200 or the use requirement, for example, the special-shaped drug balloon expansion catheter 1000 with different numbers of annular anti-skid pieces 210 can be designed to meet the rich selection to cope with the lesion blood vessels of different sizes.

[0059] The above merely describes the specific implementation of the present application, but the protection scope of the present application is not limited to this, any skilled person in the art can easily think of the changes or replacements within the technical range disclosed by the present application, which should be covered in the protection scope of the present application. Therefore, the protection scope of the present application should be subject to the protection scope of the claims.

Claims

1. A non-circular drug-eluting balloon dilation catheter, characterized in that, include: Catheter body (100); as well as A drug-eluting balloon (200) having a drug coating is disposed on the catheter body (100), and the drug-eluting balloon (200) has an annular anti-slip element (210) surrounding the axis of the drug-eluting balloon (200); The drug-eluting balloon (200) includes a balloon body and an annular anti-slip member (210). The balloon body is disposed on the catheter body (100), and the annular anti-slip member (210) protrudes from the peripheral wall of the balloon body and surrounds the axis of the balloon body. The balloon body and the annular anti-slip component (210) are integrally formed.

2. The irregularly shaped drug-eluting balloon dilation catheter according to claim 1, characterized in that, The number of the annular anti-slip components (210) is multiple, and the multiple annular anti-slip components (210) are distributed at intervals.

3. The irregularly shaped drug-eluting balloon dilation catheter according to claim 1, characterized in that, The catheter body (100) includes a tube body (110) and a push rod (120), the tube body (110) and the push rod (120) are connected, the tube body (110) includes an inner catheter (111) and an outer catheter (112), the outer catheter (112) is sleeved on the outside of the inner catheter (111), the drug balloon (200) is disposed at the distal end of the inner catheter (111), and the annular anti-slip member (210) surrounds the inner catheter (111).

4. The irregularly shaped drug-eluting balloon dilation catheter according to claim 3, characterized in that, The external catheter (112) is provided with a quick exchange port (1121), and the proximal end of the internal catheter (111) is connected to the quick exchange port (1121).

5. The irregularly shaped drug-eluting balloon dilation catheter according to claim 3, characterized in that, The tube body (110) also includes a catheter tip (113), which is connected to the distal end of the inner catheter (111).

6. The irregularly shaped drug-eluting balloon dilation catheter according to claim 3, characterized in that, The irregularly shaped drug-eluting balloon dilation catheter also includes a first imaging marker (310) and a second imaging marker (320), which are spaced apart in the inner catheter (111).

7. The irregularly shaped drug-eluting balloon dilation catheter according to claim 3, characterized in that, The catheter body (100) also includes a catheter seat (400) and a proximal connection between the catheter seat (400) and the push rod (120).

8. The irregularly shaped drug-eluting balloon dilation catheter according to claim 1, characterized in that, The drug coating is a lipophilic drug coating.