A mastoid perfusion balloon and a balloon dilation catheter

Abstract

The present invention discloses a perfusion mastoid balloon and a balloon dilation catheter, relating to the field of medical device technology. The perfusion mastoid balloon comprises a balloon body, a mastoid process, and a fluid channel; the mastoid process and the balloon body are integrally formed or separately formed; the fluid channel is formed on the outer peripheral wall of the balloon body and extends along the length of the balloon body to allow liquid to pass through, and the radial dimension of the fluid channel is less than or equal to the radial dimension of the mastoid process. The present invention improves the structure of the perfusion mastoid balloon, effectively prolongs the expansion time of the perfusion mastoid balloon, can better dilate narrow areas, and avoids blocking blood vessels.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a mastoid perfusion balloon and a balloon dilation catheter. Background Art

[0002] The balloon portion of most endovascular dilatation catheters is smooth. However, during treatment, the balloon is easily squeezed by the hard calcified lesions during the balloon pressurization process, causing the balloon to deviate from the lesion and land in a healthy blood vessel. To address this, a mastoid balloon has been developed in recent years. Multiple mastoid points are distributed on the balloon's outer surface to increase friction. These points act as a slip-resistant barrier, preventing the balloon from deviating from the calcified lesion.

[0003] However, existing mastoid balloons still have a problem: they can block blood vessels when inflated. Therefore, they are only inflated for a short time to prevent prolonged occlusion and partial tissue damage. However, this short inflation time is not effective in expanding narrowed areas, resulting in limited success in treating calcified lesions. Summary of the Invention

[0004] The main purpose of the present invention is to provide a perfusion mastoid balloon and a balloon dilation catheter, which are intended to prolong the expansion time of the mastoid balloon to improve the effect of dilating the stenotic area while avoiding blocking the blood vessels.

[0005] To achieve the above objectives, the present invention provides a mastoid perfusion balloon, comprising:

[0006] balloon body;

[0007] a mastoid, formed integrally with or separately from the balloon body; and

[0008] A fluid channel is formed on the outer peripheral wall of the balloon body and extends along the length direction of the balloon body to allow liquid to pass through, and the radial size of the fluid channel is smaller than or equal to the radial size of the mastoid in the balloon body.

[0009] Optionally, the mastoid includes a plurality of first protrusion groups and a plurality of second protrusion groups, wherein the plurality of first protrusion groups are arranged on the balloon body in a circumferential direction of the balloon body and are spaced apart and parallel to each other, and at least two second protrusion groups are provided between two adjacent first protrusion groups;

[0010] The first protrusion groups each include several anti-slip protrusions spaced apart along the length direction of the balloon body, and the second protrusion groups each include several supporting protrusions spaced apart along the length direction of the balloon body, the height of the supporting protrusions being lower than or equal to the height of the anti-slip protrusions, and a cover plate is provided on the outer end of each group of the second protrusion groups, and the cover plate and the two adjacent second protrusion groups constitute the fluid channel.

[0011] Optionally, the mastoid process includes a plurality of mastoid process groups, and the plurality of mastoid process groups are arranged on the balloon body at intervals along the circumference of the balloon body, and each of the mastoid process groups includes a plurality of anti-slip protrusions arranged at intervals along the length direction of the balloon body;

[0012] At least one fluid channel is provided between two adjacent mastoid groups, and each fluid channel includes two side walls arranged opposite to each other and a top wall arranged on the two side walls, the side walls are composed of a plurality of support columns or support bars, and the top wall is composed of a plurality of top plates.

[0013] Optionally, the cross-sectional shape of the inner cavity of the fluid channel in the radial direction of the balloon body is trapezoidal, circular or square.

[0014] Optionally, the cover plate is made of flexible metal or polymer material.

[0015] Optionally, the mastoid is provided on the outer surface of the balloon by a dispensing process.

[0016] Optionally, the outer end of the anti-slip protrusion is provided with a pointed portion suitable for piercing the blood vessel wall.

[0017] To achieve the above object, the present invention further provides a balloon dilatation catheter, comprising the above-mentioned mastoid perfusion balloon, wherein the mastoid perfusion balloon comprises:

[0018] balloon body;

[0019] a mastoid, formed integrally with or separately from the balloon body; and

[0020] A fluid channel is formed on the outer peripheral wall of the balloon body and extends along the length direction of the balloon body to allow liquid to pass through, and the radial size of the fluid channel is smaller than or equal to the radial size of the mastoid in the balloon body.

[0021] Optionally, the balloon dilatation catheter also includes a catheter and a catheter seat, the distal end of the catheter is connected to the perfusion mastoid balloon, the proximal end of the catheter is connected to the catheter seat, and the catheter seat is provided with a filling port and a guidewire port respectively connected to the filling channel and guidewire cavity of the catheter.

[0022] Optionally, the catheter includes an inner tube and an outer tube, the outer tube is arranged around the inner tube and forms the filling channel, the inner cavity of the inner tube forms the guide wire cavity, the distal end of the perfusion mastoid balloon is connected to the end of the inner tube, the proximal end of the perfusion mastoid balloon is connected to the end of the outer tube, and the proximal end of the outer tube is connected to the catheter seat.

[0023] In the technical solution of the present invention, the perfusion mastoid balloon includes a balloon body, a mastoid, and a fluid channel; the mastoid and the balloon body are integrally formed or separately formed; the fluid channel is formed on the outer peripheral wall of the balloon body and extends along the length direction of the balloon body to allow liquid to pass through, and the size of the fluid channel in the radial direction of the balloon body is less than or equal to the size of the mastoid in the radial direction of the balloon body. It can be understood that the present invention improves the structure of the perfusion mastoid balloon by providing a fluid channel on the outer surface of the balloon body to allow blood flow during expansion, thereby avoiding blockage of blood vessels. Moreover, since the size of the fluid channel in the radial direction of the balloon body is less than or equal to the size of the mastoid in the radial direction of the balloon body, the fluid channel can maintain a flow state for a longer period of time without being squeezed by the blood vessel wall, which effectively prolongs the expansion time of the perfusion mastoid balloon, can better expand the stenosis area, and improve the treatment effect of calcified lesions. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the structures shown in these drawings without paying any creative work.

[0025] Figure 1 This is a schematic structural diagram of an embodiment of a mastoid balloon perfusion according to the present invention;

[0026] Figure 2 This is a front view of an embodiment of a mastoid balloon perfusion according to the present invention;

[0027] Figure 3 for Figure 2 Cross-sectional view at AA in the middle.

[0028] Description of Figure Numbers:

[0029] 10. Balloon body; 20. Mastoid process; 30. Fluid channel; 210. First protrusion group; 220. Second protrusion group; 211. Anti-slip protrusion; 221. Support protrusion; 301. Cover plate.

[0030] The purpose, features and advantages of the present invention will be further described with reference to the accompanying drawings and in conjunction with the embodiments. DETAILED DESCRIPTION

[0031] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without creative work are within the scope of protection of the present invention.

[0032] It should be noted that all directional indications (such as up, down, left, right, front, back, etc.) in the embodiments of the present invention are only used to explain the relative position relationship, movement status, etc. between the various components under a certain specific posture (as shown in the accompanying drawings). If the specific posture changes, the directional indication will also change accordingly.

[0033] In the description of the present invention, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood broadly. For example, they may refer to fixed, detachable, or integral connections; mechanical or electrical connections; direct or indirect connections through an intermediary; and internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on the specific circumstances.

[0034] In addition, the descriptions of "first", "second", etc. in the present invention are only for descriptive purposes and cannot be understood as indicating or implying their relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. The meaning of "and / or" appearing in the full text is to include three parallel solutions. Taking "A and / or B" as an example, it includes solution A, or solution B, or a solution in which both A and B are satisfied. The technical solutions between the various embodiments can be combined with each other, but they must be based on the ability of ordinary technicians in this field to implement them. When the combination of technical solutions is mutually contradictory or cannot be implemented, it should be deemed that such a combination of technical solutions does not exist and is not within the scope of protection required by the present invention.

[0035] The present invention provides a mastoid perfusion balloon.

[0036] Reference Figures 1 to 3In one embodiment of the present invention, the perfused mastoid balloon includes a balloon body 10, a mastoid process 20, and a fluid channel 30. The mastoid process 20 and the balloon body 10 may be integrally or separately formed. The fluid channel 30 is formed on the outer peripheral wall of the balloon body 10 and extends along the length of the balloon body 10 to allow fluid to pass through. The radial dimension of the fluid channel 30 is smaller than or equal to the radial dimension of the mastoid process 20. Specifically, when the balloon is inflated, the fluid channel 30 provides a path for blood to flow through the perfused mastoid balloon, allowing blood to be supplied to the downstream area of the balloon, thereby preventing prolonged vascular occlusion and partial damage to human tissue.

[0037] In this embodiment, the mastoid 20 may include multiple protrusions set on the outer surface of the balloon through processes such as dispensing. The protrusions may be the same size or different sizes. Multiple protrusions may be evenly distributed on the outer surface of the balloon or arranged irregularly on the outer surface of the balloon. This is not limited here.

[0038] The fluid channel 30 can be formed by some of the lower protrusions in the mastoid 20 and a number of cover plates 301 or covering strips arranged on these protrusions. It can also be a structure set independently of the mastoid 20, formed by side plates and a top plate. As long as it is a structure that can allow blood to flow through and avoid blood vessel obstruction during the process of continued expansion after the mastoid 20 of the balloon penetrates the blood vessel wall, it is not limited here.

[0039] In this embodiment, the cross-sectional shape of the inner cavity of the fluid channel 30 in the radial direction of the balloon body 10 is trapezoidal, circular, square, etc., which is not limited here.

[0040] It can be understood that the present invention improves the structure of the perfusion mastoid balloon by providing a fluid channel 30 on the outer surface of the balloon body 10 to allow blood to flow through during expansion, thereby avoiding blockage of blood vessels. Moreover, since the radial size of the fluid channel 30 in the balloon body 10 is less than or equal to the radial size of the mastoid 20 in the balloon body 10, the fluid channel 30 can maintain a flow state for a longer period of time without being squeezed by the blood vessel wall, which effectively prolongs the expansion time of the perfusion mastoid balloon, can better expand the narrow area, and improve the treatment effect of calcified lesions.

[0041] Reference Figures 1 to 3In one embodiment, the mastoid 20 may include several first protrusion groups 210 and several second protrusion groups 220, and the several first protrusion groups 210 are spaced apart along the circumference of the balloon body 10 and arranged parallel to each other on the balloon body 10, and at least two second protrusion groups 220 are provided between two adjacent first protrusion groups 210, and the several second protrusion groups 220 may also be arranged parallel to each other; the first protrusion groups 210 each include several anti-slip protrusions 211 spaced apart along the length direction of the balloon body 10, and the several anti-slip protrusions 211 of each group may be on the same straight line, and the second protrusion groups 220 each include several supporting protrusions 221 spaced apart along the length direction of the balloon body 10, and the several supporting protrusions 221 of each group may also be on the same straight line, and the height of the supporting protrusions 221 is lower than or equal to the height of the anti-slip protrusions 211, and the outer end of each group of second protrusion groups 220 is covered with a cover plate 301, and the cover plate 301 and the two adjacent second protrusion groups 220 form a fluid channel 30. Thus, the fluid channel 30 allows blood to continue flowing during balloon inflation, allowing for a longer balloon expansion time, further reducing the risk of ischemia and tissue damage. Furthermore, this structure, combining the mastoid process 20 with the fluid channel 30, fully utilizes the mastoid process 20 structure of the perfusion mastoid balloon, allowing portions of the low mastoid process 20 to serve as sidewalls or support columns for the fluid channel 30, thereby reducing manufacturing complexity and lowering costs.

[0042] In this embodiment, the cover plate 301 may be made of flexible metal or polymer material to avoid squeezing the blood vessel wall and causing damage thereto during the balloon expansion process.

[0043] In another embodiment, the mastoid process 20 may include a plurality of mastoid process groups, each of which is spaced apart along the circumference of the balloon body 10. Each mastoid process group includes a plurality of anti-slip protrusions 211 spaced apart along the length of the balloon body 10. At least one fluid channel 30 is provided between two adjacent mastoid process groups. Each fluid channel 30 includes two opposing side walls and a top wall provided on the two side walls. The side walls are composed of a plurality of support columns or support bars, and the top wall is composed of a plurality of top plates. In this way, the fluid channel 30 can be configured with a specific structure according to needs, thereby achieving better stability, better extending the inflation time of the perfused mastoid balloon, further improving the effect of expanding the narrow area, and better avoiding the effect of blocking the blood vessels.

[0044] In this embodiment, the fluid channel 30 is a structure that is independently arranged from the mastoid 20. The side walls of the fluid channel 30 are not directly composed of the low mastoid 20. The side walls may be a structure similar in shape and size to the low mastoid 20 but with different materials or processes. They may also be composed of multiple support columns or several support bars. The top plate forming the top wall may be roughly the same as the structure of the cover plate 301 in the aforementioned embodiment, or they may be different, which is not limited here.

[0045] Reference Figures 1 to 3 In one embodiment, the outer end of the anti-slip protrusion 211 may be provided with a tip suitable for piercing the blood vessel wall. This arrangement can make the perfusion mastoid balloon have a better anti-slip effect, so that it can stably maintain the target treatment position during the expansion process, which helps to further improve the treatment effect.

[0046] When using the mastoid perfusion balloon, the balloon is first delivered to the lesion site in a folded and contracted state. Fluid is then added to the balloon to inflate it. During the balloon expansion process, the mastoid process 20 can pierce the blood vessel wall, preventing the balloon from sliding. The blood flow channel provides a path for blood to flow through the balloon, allowing blood to flow to the downstream area of the balloon, preventing prolonged vascular occlusion and partial damage to human tissue. After treatment, when the mastoid perfusion balloon needs to be removed from the body, the balloon is depressurized to deflate it, allowing it to be removed from the body.

[0047] The present invention also proposes a balloon dilatation catheter, which includes a perfusion mastoid balloon. The specific structure of the perfusion mastoid balloon refers to the above-mentioned embodiment. Since the balloon dilatation catheter proposed by the present invention includes all schemes of all embodiments of the above-mentioned perfusion mastoid balloon, it has at least the same technical effects as the above-mentioned perfusion mastoid balloon, which will not be elaborated here one by one.

[0048] In one embodiment, the balloon dilatation catheter may further include a catheter and a catheter hub, wherein the distal end of the catheter communicates with the mastoid perfusion balloon, and the proximal end of the catheter communicates with the catheter hub. The catheter hub may be a Y-shaped hollow structure, and may include a filling port and a guidewire port, each communicating with the catheter's filling channel and the guidewire lumen, respectively. This facilitates medical personnel in delivering the balloon to the target treatment site and facilitates balloon inflation.

[0049] In this embodiment, the catheter may include an inner tube and an outer tube. The outer tube surrounds the inner tube and forms a filling channel, which communicates with the inner lumen of the balloon. The inner tube extends through the balloon, and the inner lumen of the inner tube forms a guidewire lumen. The distal end of the mastoid perfusion balloon is connected to the end of the inner tube, and the proximal end of the mastoid perfusion balloon is connected to the end of the outer tube. The proximal end of the outer tube is connected to the catheter seat. This mastoid perfusion balloon dilation catheter has a relatively simple structure, is more convenient to manufacture and process, and has a lower cost.

[0050] The above descriptions are merely optional embodiments of the present invention and do not limit the patent scope of the present invention. All equivalent structural transformations made using the contents of the present description and drawings under the inventive concept of the present invention, or direct / indirect applications in other related technical fields, are included in the patent protection scope of the present invention.

Claims

1. A mastoid perfusion balloon, characterized in that: include: balloon body; a mastoid, formed integrally with or separately from the balloon body; as well as a fluid channel formed on the outer peripheral wall of the balloon body and extending along the length direction of the balloon body to allow liquid to pass through, wherein the radial dimension of the fluid channel is smaller than or equal to the radial dimension of the mastoid process; The mastoid comprises a plurality of first protrusion groups and a plurality of second protrusion groups, wherein the plurality of first protrusion groups are spaced apart along the circumference of the balloon body and are arranged parallel to each other on the balloon body, and at least two second protrusion groups are arranged between two adjacent first protrusion groups; The first protrusion groups each include several anti-slip protrusions spaced apart along the length direction of the balloon body, and the second protrusion groups each include several supporting protrusions spaced apart along the length direction of the balloon body, the height of the supporting protrusions being lower than or equal to the height of the anti-slip protrusions, and a cover plate is provided on the outer end of each group of the second protrusion groups, and the cover plate and the two adjacent second protrusion groups constitute the fluid channel.

2. The mastoid perfusion balloon according to claim 1, wherein: The cross-sectional shape of the inner cavity of the fluid channel in the radial direction of the balloon body is trapezoidal, circular or square.

3. The mastoid perfusion balloon according to claim 1, wherein: The cover plate is made of flexible metal or polymer material.

4. The mastoid perfusion balloon according to claim 1, wherein: The mastoid is arranged on the outer surface of the balloon through a dispensing process.

5. The mastoid perfusion balloon according to claim 1, wherein: The outer end of the anti-slip protrusion is provided with a tip portion suitable for piercing the blood vessel wall.

6. A balloon dilatation catheter, characterized in that: It comprises the perfusion mastoid balloon as described in any one of claims 1 to 5.

7. The balloon dilatation catheter according to claim 6, characterized in that: The balloon dilatation catheter also includes a catheter and a catheter seat. The distal end of the catheter is connected to the perfusion mastoid balloon, and the proximal end of the catheter is connected to the catheter seat. The catheter seat is provided with a filling port and a guidewire port respectively connected to the filling channel and guidewire cavity of the catheter.

8. The balloon dilatation catheter according to claim 7, characterized in that: The catheter includes an inner tube and an outer tube. The outer tube is arranged around the inner tube and forms the filling channel. The inner cavity of the inner tube forms the guide wire cavity. The distal end of the perfusion mastoid balloon is connected to the end of the inner tube, and the proximal end of the perfusion mastoid balloon is connected to the end of the outer tube. The proximal end of the outer tube is connected to the catheter seat.

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