Embedded mastoid balloon catheter

Abstract

The utility model relates to an embedded mastoid balloon catheter which comprises a balloon body, the balloon body comprises a balloon wall, an inner cavity is defined in the balloon wall, a plurality of protruding parts facing outwards in the radial direction are distributed on the balloon wall, and concave areas are correspondingly formed on the inner sides of the protruding parts; the interior of the inner tube is axially through and serves as a guide wire channel, the balloon body is located on the periphery of the inner tube, and the far end of the balloon body is connected with the outer wall of the inner tube in a sealed mode; the outer tube is arranged outside the inner tube in a sleeving mode, the near end of the balloon body is in butt joint with the far end of the outer tube, and a radial gap between the outer tube and the inner tube is a fluid channel communicated with the inner cavity; and at least one part of the supporting piece is fixedly filled in the concave area. According to the mastoid balloon catheter, through structural improvement, the supporting piece forming the mastoid points and providing the expected strength is fixed to the inner wall of the balloon wall of the balloon body, and the safety risk that the mastoid points fall off in the prior art can be eliminated.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to an embedded papillary balloon catheter. Background Technology

[0002] Balloon angioplasty is a common technique in interventional vascular therapy for improving vascular stenosis. Conventional balloons dilate the narrowed area of ​​the blood vessel by blunt dislodgement. This mechanism can easily cause irregular damage to the vessel wall, leading to risks such as residual stenosis and vascular dissection. Therefore, there is room for improvement in treatment efficacy and safety.

[0003] To address these issues, specialized balloons have emerged. These balloons, by modifying the surface or structure of ordinary balloons, significantly improve the dilation effect of vascular stenosis lesions while effectively reducing the risk of damage to the vascular wall. However, existing specialized balloons still face technical bottlenecks: for patients with mild or moderate atherosclerosis, products such as cutting balloons and scoring balloons already in clinical use have poor delivery capabilities due to their large folded outer diameter, easily causing additional damage to the patient's blood vessels when entering the lesion site; while papillary balloons with surface-attached papillary points can crush vascular plaques during dilation through the stress concentration effect generated by the papillary points, when treating calcified lesions, especially in-stent restenosis, the balloon tends to slide towards easily dilated areas of the blood vessel, potentially causing papillary point detachment due to shear force. Detached papillary points can move with the blood flow, easily triggering vascular embolism and seriously threatening the patient's life and health. Utility Model Content

[0004] This application provides a mastoid balloon catheter that further improves safety in use, avoiding mastoid point dislodgement and the resulting safety hazards.

[0005] This application discloses an embedded mastoid balloon catheter, comprising:

[0006] The balloon body includes a balloon wall, the balloon wall having an internal cavity defined therein, and the balloon wall having a plurality of radially outward protrusions and corresponding recessed areas formed on the inner side of the protrusions.

[0007] The inner tube is axially connected and serves as a guide wire channel. The balloon body is located on the outer periphery of the inner tube, and the distal end of the balloon body is sealed to the outer wall of the inner tube.

[0008] An outer tube is fitted over the inner tube, with the proximal end of the balloon body abutting the distal end of the outer tube. The radial gap between the outer tube and the inner tube forms a fluid channel communicating with the inner cavity.

[0009] A support member, at least a portion of which is fixedly filled in the recessed area.

[0010] Several alternative methods are provided below, but they are not intended as additional limitations on the overall solution above. They are merely further additions or optimizations. Provided there are no technical or logical contradictions, each alternative method can be combined individually with respect to the overall solution above, or multiple alternative methods can be combined with each other.

[0011] Optionally, the support member is a prefabricated part and fixed to the recessed area, or the support member is a curable material and is formed in situ in the recessed area.

[0012] Optionally, the axial length of the balloon body is 5-40 mm; the diameter is 1.5-10 mm.

[0013] Optionally, the protrusion height of the protrusion is 0.05-0.30 mm.

[0014] Optionally, the protrusions are arranged in 3 to 8 groups at intervals along the circumference of the balloon body; the protrusions in the same group include 2 to 8 protrusions arranged at intervals along the axial direction of the balloon body.

[0015] Optionally, the supporting components corresponding to the protrusions in the same group can be a single integrated structure.

[0016] Optionally, the support member corresponding to the protrusion in the same group is a spindle wire, including a wire body and spindles spaced apart on the wire body, with each spindle inserted into a corresponding recessed area.

[0017] Optionally, the support member is made of a magnetically responsive material.

[0018] Optionally, the protrusion includes opposing hard protrusions and soft protrusions, wherein the protrusion height of the hard protrusion is greater than the protrusion height of the soft protrusion.

[0019] Optionally, the height difference between the hard protrusion and the soft protrusion is 0.1 to 1 mm.

[0020] The mastoid balloon catheter of this application, through structural improvements, fixes the support member that forms the mastoid point and provides the expected strength to the inner wall of the balloon body. Even if the mastoid point (i.e. the outward convex part of the balloon wall) rubs against the surrounding tissue, the support member will not fall off. Moreover, even if the support member falls off, it will be scattered inside the balloon body and will not enter the blood vessel, thus eliminating the safety risk of mastoid point detachment in the prior art. Attached Figure Description

[0021] To more clearly illustrate the technical solutions in the embodiments of this application or the conventional technology, the drawings used in the description of the embodiments or the conventional technology will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0022] Figure 1 This is a three-dimensional schematic diagram of the papillary balloon catheter in one embodiment of this application;

[0023] Figure 2 for Figure 1 A three-dimensional schematic diagram of the central saccule;

[0024] Figure 3 for Figure 2 Side view of the central saccule;

[0025] Figure 4 This is a schematic diagram of the balloon body in another embodiment of this application;

[0026] Figure 5 for Figure 3 Left view of the middle saccule;

[0027] Figure 6 for Figure 3 Schematic diagram of the internal structure of the central sac;

[0028] Figure 7 for Figure 6 A magnified view of a portion of the image;

[0029] Figure 8 This is a structural schematic diagram of the location of the support member in another embodiment of this application;

[0030] Figure 9 This is a structural schematic diagram of the support member in another embodiment of this application;

[0031] Figure 10 for Figure 9 A schematic diagram of the structure in which the support component is placed inside the balloon body;

[0032] Figure 11 for Figure 10 Schematic diagram of the structure of the middle sac;

[0033] Figure 12 This is a structural schematic diagram of the location of the support member in another embodiment of this application;

[0034] Figure 13 This is a schematic diagram of the structure of the balloon body in another embodiment of this application;

[0035] Figure 14 for Figure 13 Schematic diagram of the cross-section of the central sac;

[0036] Figure 15 This is a schematic diagram of the structure of the balloon body in another embodiment of this application;

[0037] Figure 16 This is a schematic diagram of the structure of the balloon body in another embodiment of this application.

[0038] The component labels are as follows:

[0039] 100. Body of the balloon; 101. Distal end; 102. Proximal end; 110. Wall of the balloon; 120. Lumen; 130. Protrusion; 131. Hard protrusion; 132. Soft protrusion; 140. Depression area; 150. Rib;

[0040] 200. Pipe fitting; 210. Inner tube; 211. Guide wire channel; 220. Outer tube; 230. Fluid channel;

[0041] 300, Support component; 301, Wire body; 302, Spike; 310, Light-emitting element. Detailed Implementation

[0042] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0043] It should be noted that when a component is referred to as being "fixed to" or "set on" another component, it can be directly on the other component or there may be an intermediate component. When a component is considered to be "connected to" another component, it can be directly connected to the other component or there may be an intermediate component present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application's specification are for illustrative purposes only and do not represent the only possible implementation.

[0044] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0045] In this application, unless otherwise expressly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature and the second feature are in indirect contact through an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level (or in a usage state, or from a certain viewpoint in the drawing) than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level (or in a usage state, or from a certain viewpoint in the drawing) than the second feature.

[0046] Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The term "and / or" as used in this application includes any and all combinations of one or more of the associated listed items.

[0047] See Figures 1-5 One embodiment of this application provides an embedded mastoid balloon catheter, including a balloon body 100, a tubing 200, and a support 300.

[0048] The balloon body 100 includes a balloon wall 110, and the inside of the balloon wall 110 defines an inner cavity 120. The balloon wall 110 itself can be obtained by blow molding in one step or by secondary processing.

[0049] The capsule wall 110 has multiple radially outward protrusions 130, and corresponding recessed areas 140 are formed on the inner side of the protrusions 130. As a papillary balloon, in order to further improve the support strength and / or rigidity at the location of the papillary point, i.e., the protrusions 130, a support member 300 is provided inside the capsule wall 110, and part or all of the support member 300 is fixedly filled in the corresponding recessed area 140.

[0050] The balloon body 100 has a distal end 101 and a proximal end 102 along the axial direction. When in use, the distal end 101 is the side away from the user, and the proximal end 102 is the side closer to the user. Correspondingly, other components also have a distal end and a proximal end, which makes it easier to understand the different parts or relative positional relationships of each component.

[0051] The fitting 200 specifically includes an inner tube 210 and an outer tube 220. The inner tube 210 is axially oriented and serves as a guidewire channel 211 for guidewire passage during interventional delivery. The balloon body 100 is located on the outer periphery of the inner tube 210, and the distal end of the balloon body 100 is sealed to the outer wall of the inner tube 210.

[0052] The outer tube 220 is fitted outside the inner tube 210. The proximal end of the balloon body 100 is connected to the distal end of the outer tube 220. The radial gap between the outer tube 220 and the inner tube 210 is a fluid channel 230 that communicates with the inner cavity 120. Fluid can be injected through the fluid channel 230 to inflate the balloon body 100. After use, the fluid is discharged, and the balloon body 100 collapses or folds to facilitate recovery.

[0053] In this embodiment, the support 300 is disposed inside the balloon body 100, which greatly reduces the risk of detachment and improves the safety of the device. As for the support 300 itself, it can be a prefabricated part, which is fixed to the recessed area 140 after processing and molding, or the support 300 can be a curable material and molded in situ in the recessed area 140, for example, injecting light-curable adhesive into the recessed area 140 and then curing it with light.

[0054] The support 300 may be one or more of a metallic material, a ceramic material, a polymeric material, an adhesive material, a hydrophilic material, or other materials, which are deposited, welded, coated, or otherwise applied to the recessed area 140.

[0055] The protrusion 130 has a radially raised height H relative to the other parts of the sac wall 110, where H is 0.05-0.50 mm, for example, 0.05-0.30 mm. The protrusion 130 is spherical or ellipsoidal, for example, hemispherical, with a diameter of 0.12-0.80 mm.

[0056] There are multiple protrusions 130, for example, 3 to 8 groups, or 4 to 6 groups, are arranged at intervals along the circumference of the balloon body. Each group of protrusions includes 2 to 20 protrusions arranged at intervals along the axial direction of the balloon body, or 4 to 10 protrusions.

[0057] Combination Figure 3 Along the axial direction of the balloon body, the distance L1 between two adjacent protrusions in the same group is 0.5 to 6 times the height H of the protrusion, for example, 2 to 4 times.

[0058] Combination Figure 4 The balloon body 100 has an axial length L, which is 5-40 mm long, and a diameter D, which is 1.5-10 mm long. Figure 3 and Figure 4 The illustration shows balloon bodies 100 of different lengths, of course... Figure 4 The number of papillae in the body also increases accordingly.

[0059] Combination Figure 5 Along the circumference of the balloon body, the distance L2 between two adjacent sets of protrusions is 0.5 to 6 times the height H of the protrusion, for example, 2 to 4 times.

[0060] See Figure 6 , Figure 7In one embodiment, the support member 300 is spherical and the recessed area 140 is hemispherical. Approximately half of the support member 300 is inserted into the corresponding side recessed area 140. Specifically, the support member 300 can be a steel ball and is bonded and fixed in the recessed area 140 by light-curing adhesive.

[0061] See Figure 8 In another embodiment, the support 300 is hemispherical, substantially matching the shape of the recessed area 140 and filling the recessed area 140.

[0062] See Figures 9-11 In another embodiment, the support member 300 corresponding to the same group of protrusions 130 is an integral structure. For example, the support member 300 corresponding to the same group of protrusions 130 is a metal spindle wire, including a wire body 301 and spindles 302 spaced apart from the wire body 301. Each spindle 302 is placed into a corresponding recessed area 140. The spindles 302 can be formed by bending the spindle wire itself. Since the circumferentially aligned recessed areas 140 share the same spindle wire, after the balloon body 100 is inflated, the position corresponding to the spindle wire can also form a radially outward protruding rib 150, which can also serve as a cutting blade and has the function of cutting the balloon.

[0063] Whether it is a steel ball or a ratchet wire, the support 300 can also be made of a magnetically responsive material, which can respond to an external magnetic field. This makes it easier to pre-position the support 300 by means of a magnetic field during processing and assembly, and then further fix it to the mating part of the recessed area 140 by bonding or other means, making the operation more convenient and improving the assembly efficiency.

[0064] See Figure 12 The support 300 may also encapsulate a light-emitting element 310, which can emit red or blue light as needed to assist in treatment. In use, the mastoid balloon catheter also includes a driver that is electrically connected to the light-emitting element 310.

[0065] To optimize the circuit layout, the support member 300 corresponding to the protrusion 130 in the same group is a metal strip, and each light-emitting element 310 is fixed at intervals to the metal strip. The light-emitting elements 310 are also connected in series in the circuit by the metal strip as a conductor.

[0066] See Figures 13-16 In other embodiments, the protrusion 130 includes opposing hard protrusions 131 (distinguished by fill lines in the figure) and soft protrusions 132. The corresponding recessed areas 140 of the two are provided with support members 300 of different hardness, so they can work together. For example, the hard protrusion 131 can separate the plaque, while the soft protrusion 132 can further compress the plaque, but can prevent the plaque from tearing too much and avoid plaque falling off and causing hidden dangers.

[0067] To achieve different hardness levels, different support components are used in each recessed area 140. For example, the support component 300 used in the recessed area of ​​the hard protrusion 131 is a metal ball, while the support component 300 used in the recessed area of ​​the soft protrusion 132 is a cured adhesive.

[0068] The support member of the hard protrusion 131 has a hardness greater than 50HV, for example, 120-180HV. The support member of the soft protrusion 132 has a hardness of 55D-90D, preferably 64D.

[0069] In order to cooperate with each other and act on the lesion, the protrusion height H1 of the hard protrusion 131 is greater than the protrusion height H2 of the soft protrusion 132. For example, the difference in protrusion height between the hard protrusion 131 and the soft protrusion 132 is 0.1 to 1 mm, preferably 0.1 to 0.5 mm.

[0070] In some embodiments, the hard protrusions 131 and soft protrusions 132 in the same group of protrusions are arranged alternately or with the same hardness.

[0071] See Figure 13 In one embodiment, all protrusions in the same group are hard protrusions 131 or all are soft protrusions 132. In two adjacent groups of protrusions, one group is hard protrusions 131 and the other group is soft protrusions 132.

[0072] See Figure 15 In one embodiment, hard protrusions 131 and soft protrusions 132 are arranged alternately within the group, and the hard protrusions 131 between groups are aligned with each other along the circumference of the balloon body.

[0073] See Figure 16 In one embodiment, the hard protrusions 131 and soft protrusions 132 are arranged alternately within the group, and the hard protrusions 131 between the groups are staggered along the circumference of the balloon body.

[0074] This application further improves the structure of the existing papillary balloon, greatly enhancing the safety of the product.

[0075] The technical features of the above embodiments can be combined arbitrarily. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as the combination of these technical features does not contradict each other, it should be considered to be within the scope of this specification. When technical features of different embodiments are embodied in the same drawing, it can be regarded as the drawing also disclosing examples of combinations of the various embodiments involved.

[0076] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the scope of protection of this application. Therefore, the patent protection scope of this application should be determined by the appended claims.

Claims

1. An in-line papillary balloon catheter, characterized by, include: The balloon body includes a balloon wall, the balloon wall having an internal cavity defined therein, and the balloon wall having a plurality of radially outward protrusions and corresponding recessed areas formed on the inner side of the protrusions. The inner tube is axially connected and serves as a guide wire channel. The balloon body is located on the outer periphery of the inner tube, and the distal end of the balloon body is sealed to the outer wall of the inner tube. An outer tube is fitted over the inner tube, with the proximal end of the balloon body abutting the distal end of the outer tube. The radial gap between the outer tube and the inner tube forms a fluid channel communicating with the inner cavity. A support member, at least a portion of which is fixedly filled in the recessed area.

2. The nested pust balloon catheter of claim 1, wherein, The support is a prefabricated component and fixed to the recessed area, or the support is a curable material and formed in situ in the recessed area.

3. The nested pust balloon catheter of claim 1, wherein, The axial length of the balloon is 5-40 mm; the diameter is 1.5-10 mm.

4. The nested pust balloon catheter of claim 3, wherein, The protrusion height of the protrusion is 0.05-0.30mm.

5. The nested pust balloon catheter of claim 1, wherein, The protrusions are arranged in 3 to 8 groups at intervals along the circumference of the balloon body; the protrusions in the same group include 2 to 8 protrusions arranged at intervals along the axial direction of the balloon body.

6. The nested pust balloon catheter of claim 5, wherein, The supporting components corresponding to the protrusions in the same group are an integral structure.

7. The nested pust balloon catheter of claim 6, wherein, The support member corresponding to the protrusion in the same group is a spiny filament, including a filament body and spiny protrusions arranged at intervals on the filament body, with each spiny protrusion placed into a corresponding recessed area.

8. The nested pust balloon catheter of claim 1, wherein, The support component is made of a magnetically responsive material.

9. The nested pust balloon catheter of claim 1, wherein, The protrusion includes a hard protrusion and a soft protrusion, wherein the protrusion height of the hard protrusion is greater than the protrusion height of the soft protrusion.

10. The nested pust balloon catheter of claim 9, wherein, The height difference between the hard protrusion and the soft protrusion is 0.1 to 1 mm.

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