Improved medical balloon device

Abstract

The application discloses an improved medical balloon device, which comprises a balloon body, the balloon body is a hollow structure and has opposite distal and proximal ends, a catheter for conveying fluid into the balloon body is communicated with the proximal end of the balloon body, and a reinforcing net is fixed to the periphery of the balloon body. The reinforcing net is woven by a single reinforcing wire and forms a grid structure arranged in rows and columns. The reinforcing net is arranged in the axial direction of the balloon body between the rows and has the same span in the axial direction of the balloon body between the adjacent two rows. The reinforcing net is arranged in the circumferential direction of the balloon body between the columns and has different spans in the circumferential direction of the balloon body between the adjacent two columns.

Description

Technical Field

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

[0002] Balloon angioplasty, as a primary treatment method or an adjunct to stents or other devices, remains a core direction in interventional vascular surgery. However, the challenge of restenosis after endovascular treatment has been a major concern. While bare-metal stents and drug-eluting stents can improve the patency rate after conventional balloon angioplasty, they also bring challenges such as delayed endothelial healing, chronic inflammation, neoatherosclerosis, stent fracture, and in-stent thrombosis, all of which can lead to in-stent restenosis.

[0003] The technique of balloon dilation during angioplasty has a crucial impact on treatment outcomes: insufficient dilation pressure can lead to elastic rebound, while over-dilation can cause neointimal hyperplasia and restenosis. Achieving the best treatment results requires minimizing strain on the vessel wall. Compared to ordinary balloons, specialized balloons are products that combine other technologies with ordinary balloons, possessing functions such as balloon dilation, drug delivery, cutting, and cryotherapy, providing new strategies and methods for the treatment of peripheral atherosclerotic lesions.

[0004] High-pressure balloons are designed to treat complex vascular conditions, including severe calcification leading to vascular obstruction. Liang Qiongxian et al., in their article "Comparison of the Efficacy of Bard High-Pressure Balloons and Ordinary Peripheral Balloons in the Treatment of Forearm Autogenous Arteriovenous Fistula Stenosis," compared the advantages and disadvantages of Bard high-pressure balloons and ordinary balloons. The results showed that the success rate and patency rate at 6 months were higher with Bard balloons than with ordinary balloons. Bard high-pressure balloons refer to balloons with a burst pressure of 30 atm, which avoids the "dog bone effect" during dilation, effectively dilating calcified and obstructed vascular lesions. In a study by Trerotola SO et al. on the treatment of 87 cases of venous stenosis with standard high-pressure balloons, the success rate of dilation reached 100% in 7 patients who failed dilation, after using ultra-high-pressure balloons.

[0005] Existing high-pressure balloons can incorporate reinforcing fibers on the outside of the balloon body, but this also brings other problems, and the overall effect still needs to be improved. Summary of the Invention

[0006] Therefore, it is necessary to provide a medical balloon device to address the aforementioned technical problems.

[0007] Improved medical balloon devices include:

[0008] A balloon body, the balloon body having a hollow structure and having a distal end and a proximal end, wherein a conduit for delivering fluid into the balloon body is connected to the proximal end of the balloon body;

[0009] A reinforcing mesh is fixed to the periphery of the balloon body. The reinforcing mesh is woven from a single reinforcing filament and forms a grid structure with rows and columns. Each row is arranged along the axial direction of the balloon body and adjacent rows have the same span in the axial direction of the balloon body. Each column is arranged along the circumferential direction of the balloon body and adjacent columns have different spans in the circumferential direction of the balloon body.

[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 reinforcing wire is spirally wound around the outside of the balloon body. The reinforcing wire also has an undulating structure as it extends along the winding path. The undulating structure has relative peaks and troughs. The spiral winding consists of multiple turns arranged along the axial direction of the balloon body. In two adjacent turns, the peak of one turn is intertwined with two adjacent troughs in the other turn.

[0012] Optionally, the width of the crest is W1, and the width of the trough is W2, satisfying W1:W2 = 1:1.2~6.

[0013] Optionally, the reinforcing mesh is fixed to the outer surface of the balloon body by bonding or hot-melt.

[0014] Optionally, the balloon body includes an equal-diameter section in the middle and tapered sections at both ends along the axial direction. In the equal-diameter section, adjacent rings form multiple cell structures, and the number of cells in the circumferential direction of the balloon body is 6 to 48.

[0015] Optionally, in each cell, the cell surrounded by peaks is the first cell, with an area of ​​S1; the cell surrounded by troughs is the second cell, with an area of ​​S2; and S1 + S2 = 4 to 20 mm. 2 .

[0016] Optionally, the crests of two adjacent rings can be aligned.

[0017] Optionally, the reinforcing wire is twisted in a single strand or multiple strands.

[0018] Optional, the reinforcing wire is:

[0019] Round wires, with a diameter ranging from 50 to 200 μm;

[0020] Or flat filaments, with a width of 100–300 μm and a thickness of 50–100 μm.

[0021] Optionally, among the reduced diameter sections on both sides of the equal diameter section, the reduced diameter section at the distal end converges to the farthest end, and the reduced diameter section at the proximal end converges to the conduit. The two ends of the single reinforcing wire extend and are fixed to the end or the conduit after passing through the reduced diameter sections on the corresponding sides.

[0022] The improved medical balloon device of this application balances the working strength and flexibility of the balloon body by improving the fiber weaving method. Attached Figure Description

[0023] Figure 1 This is a schematic diagram of the structure of an improved medical balloon device according to an embodiment of this application;

[0024] Figure 2 for Figure 1 A schematic diagram of the structure of the central sac;

[0025] Figures 3a-3c for Figure 2 Schematic diagram of the structure of the reinforced mesh;

[0026] The annotations in the figure are explained as follows:

[0027] 5. Catheter; 10. Balloon body; 10a. Isodiameter segment; 10b. Narrow segment; 11. Proximal end; 12. Distal end; 14. Reinforcing mesh; 15. Reinforcing wire; 16. Cell; 16a. First cell; 16b. Second cell;

[0028] Z1, point;

[0029] X1, span; X2, span; Y, span;

[0030] C1, First lap; A1, Peak; B1, Trough; B2, Trough; C2, Second lap; A2, Peak;

[0031] W1, crest width; W2, trough width; L1, circumferential length;

[0032] S1, area; S2, area. Detailed Implementation

[0033] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0034] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0035] In this application, the terms “comprising” and “having”, and any variations thereof, are intended to cover non-exclusive inclusion, for example, a system, product, or device that includes a series of units is not necessarily limited to those units that are explicitly listed, but may include other units that are not explicitly listed or that are inherent to such products or devices.

[0036] In this application, terms such as "center," "length," "width," "thickness," "top," "bottom," "upper," "lower," "left," "right," "front," "rear," "vertical," "horizontal," "inner," "outer," "axial," and "circumferential" indicate orientation or positional relationships based on the orientation or positional relationships shown in certain accompanying drawings, or based on the spatial posture of the product under normal use. Of course, they are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the location or original object must have a specific orientation, or a specific structure and operation. Therefore, they should not be construed as limitations on this application.

[0037] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "linking," "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection, an electrical connection, or a connection that allows communication between components; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0038] Existing medical balloon devices include a balloon body and a woven mesh. The balloon body is a hollow structure with a distal and a proximal end, and a conduit for delivering fluid into the balloon body is connected to the proximal end of the balloon body.

[0039] In existing technologies, the braided mesh is formed by multiple braided filaments wrapped around the outer surface of the balloon body. These filaments are bonded and gathered at the ends of the balloon body, reducing the flexibility of both ends of the medical balloon device, increasing the difficulty of interventional procedures, and even posing safety hazards. As the shape of the two ends of the medical balloon device gradually tapers, the braided filaments wrapped around these areas are at risk of further slippage, making it impossible to guarantee the ability to withstand the working pressure.

[0040] See Figure 1 , Figure 2 and Figure 3a ~b, One embodiment of this application provides an improved medical balloon device, including a balloon body 10 and a reinforcing mesh 14. The balloon body 10 is a hollow structure with a distal end 12 and a proximal end 11. A conduit 5 for delivering fluid into the balloon body 10 is connected to the proximal end 11. The reinforcing mesh 14 is fixed to the outer periphery of the balloon body 10. The reinforcing mesh 14 is woven from a single reinforcing wire 15 to form a grid structure arranged in rows and columns. Each row is arranged along the axial direction of the balloon body 10, and adjacent rows have the same span Y1 along the axial direction of the balloon body 10. Each column is arranged circumferentially around the balloon body 10, and adjacent columns have different spans along the circumferential direction of the balloon body 10.

[0041] like Figure 2 As shown, the reinforcing mesh is formed by winding a single reinforcing wire 15, which extends to both ends of the balloon body 10. Figure 3a As shown, although point Z1 is located in different positions (different rows) in the diagram, in the actual product, the two points Z1 at which the reinforcing mesh 14 is curled and placed around the outer periphery of the spherical body 10 coincide. For example... Figure 3b As shown, the span between two adjacent rows in the circumferential direction is different, forming periodically changing spans X1 and X2 respectively.

[0042] like Figure 2 As shown, in this embodiment, the balloon body 10 includes, along its axial direction, a constant-diameter section 10a in the middle and tapered constricted sections 10b at both ends. Of the constricted sections 10b on both sides of the constant-diameter section 10a, the constricted section 10b at the distal end 12 converges to one end of the distal end 12, and the constricted section 10b at the proximal end 11 converges to the catheter 5. The two ends of the single reinforcing wire 15 extend through the corresponding constricted sections 10b and are respectively fixed to the tip or the catheter 5. Figure 2 As shown, the two ends of the reinforcing wire 15 extend and are fixed to the tip (distal end 12) and the catheter 5, respectively. It can be understood that... Figures 3a-3c This is only a schematic diagram of the reinforced mesh structure. The sparseness of the reinforced mesh can be adjusted by adjusting the size of the span Y, span X1, and span X2.

[0043] In this embodiment, a single reinforcing wire 15 (corresponding to multiple braided wires in the prior art) is woven from the head end 12 of the balloon body 10 to the proximal end 11. The weaving method of the reinforcing wire 15 ensures the function of the reinforcing mesh 14, giving the reinforcing mesh excellent integrity and synergy. While ensuring the function of the reinforcing mesh 14, the reinforcing wire 15 extends and is fixed at both ends of the balloon body 10, improving the flexibility and passability at both ends of the medical balloon device and reducing the difficulty of interventional operations.

[0044] See Figure 2The reinforcing mesh 14 is fixed to the outer surface of the balloon body 10 by bonding (e.g., using adhesives of polyurethane, polyvinyl chloride, etc., the adhesive curing method can be natural curing or UV curing) or by hot melting.

[0045] In one embodiment, the reinforcing filament 15 is fabricated using a single-strand or multi-strand twisting method. The reinforcing filament 15 can be a round filament or a flat filament. The diameter of the round filament ranges from 50 to 200 μm; the width of the flat filament ranges from 100 to 300 μm, and the thickness ranges from 50 to 100 μm. In this embodiment, the reinforcing filament 15 is selected from a flexible biomedical polymer material, such as nylon, polyether block polyamide, polytetrafluoroethylene, or polyethylene, to ensure the safety and effectiveness of the product during use.

[0046] See Figure 2 and Figure 3c The reinforcing wire 15 is spirally wound around the outside of the balloon body 10. The reinforcing wire 15 also has an undulating structure as it extends along the winding path. The undulating structure has relative peaks and valleys. The spiral winding consists of multiple turns arranged along the axial direction of the balloon body 10. In two adjacent turns, the peak of one turn is intertwined with the two adjacent valleys in the other turn.

[0047] In this embodiment, the reinforcing wire 15 forms different loops (manifested as...) Figure 3c (Different rows shown). Each coil of reinforcing wire 15 extends circumferentially along the balloon body 10, with axial spacing between coils (rows), creating an undulating structure in the axial direction of the balloon body 10. For each coil of reinforcing wire 15, there are periodically varying peaks and troughs in the axial direction, i.e., relative peaks and troughs. In this embodiment, the direction closer to the proximal end 11 is defined as the peak direction. See also... Figure 3c In two adjacent loops, taking the first loop C1 and the second loop C2 as an example, the peak A2 of the second loop C2 is simultaneously intertwined with the troughs B1 and B2 of the first loop C1. The first loop C1 and the second loop C2 pull on each other axially, forming tensile forces in different loops.

[0048] In different implementations, the peaks of two adjacent rings are aligned. For example... Figure 3c As shown, the peak A1 of the first circle C1 and the peak A2 of the second circle C2 are directly opposite each other.

[0049] See Figure 3c In each cell 16, the cell surrounded by the crests is the first cell 16a, with an area of ​​S1; the cell surrounded by the troughs is the second cell 16b, with an area of ​​S2; and the conditions S1 + S2 = 4 ~ 20 mm are met. 2 .

[0050] Furthermore, the width of the crest is W1, and the width of the trough is W2, satisfying a ratio of W1:W2 = 1:1.2 to 6. It can be understood that the ratio of the crest width W1 to the trough width W2 affects the span between different columns in the circumferential direction. That is, in the circumferential direction of the balloon body, the first cell 16a and the second cell 16b are alternately distributed. The first cell 16a forms a crest width W1 (represented as a span X1) in the circumferential direction of the balloon body; the first cell 16a forms a trough width W2 (represented as a span X2) in the circumferential direction of the balloon body. In the equal-diameter segment 10a, adjacent rings form multiple cell 16 structures, and the number of cells 16 in the circumferential direction of the balloon body is 6 to 48. Specifically, 8 to 36 is preferred. The fewer the number of cells 16, the smaller the diameter of the folded balloon. It is understandable that the number of cells in the circumferential direction is reflected in the proportion of length, that is, the circumferential length of the scapula is L1, and L1 is 3 to 24 times the sum of W1 and W2.

[0051] In use, see Figure 3c In this embodiment, when the medical balloon device is internally pressurized (by filling with fluid), the balloon body 10 bulges as a whole. Since the elasticity of the reinforcing wire 15 is less than that of the balloon body 10, an uneven plane (i.e., a protrusion) is formed on the outer surface of the balloon body 10, with the protrusions located at the positions of cell 16. The evenly distributed protrusions enable the balloon body 10 to dilate severely obstructed blood vessels.

[0052] Traditional warp and weft weaving methods struggle to balance the formation of protrusions with the stability of cell units. For example, using a sparsely woven mesh (corresponding to the reinforcing mesh in various embodiments of this application) can lead to misalignment at the warp and weft intersections due to a lack of mutual force. When the balloon bulges, the weft threads around each cell deform, causing severe cell deformation. Enlarged cells result in the weft mesh at the deformed cells losing its ability to restrain the balloon, reducing its load-bearing capacity and failing to achieve the desired effect, even posing safety hazards. Conversely, using a densely woven mesh results in relatively small cell areas (compared to a sparsely woven mesh), making it difficult to form protrusions and leading to ineffective medical balloon devices.

[0053] The reinforcing mesh of the product in this application can be implemented using existing technologies, for example, in terms of its processing method. Figure 2 The middle part can be formed using a method similar to weft knitting.

[0054] When the balloon body 10 is pressurized to 40 atm, the height of the protrusion in cell 16 gradually increases, with the height of the first cell 16a ranging from 0.1 to 1 mm and the height of the second cell 16b ranging from 0.1 to 1 mm. Furthermore, when the balloon body 10 is pressurized to 40 atm and the number of circumferential grids is 8, the height of the protrusion in the first cell 16a after pressurization is 0.2 mm, and the height of the protrusion in the second cell 16b is also 0.2 mm.

[0055] In the prior art, when the surface of the balloon body 10 is not covered with the reinforcing mesh 14, the maximum burst pressure of the balloon body 10 is 20 atm; taking the axial length of the balloon body 10 as 15cm and the diameter as 6mm as an example, after the surface is covered with the reinforcing mesh 14, the maximum burst pressure of the balloon body 10 under the action of the reinforcing mesh 14 reaches 40 atm.

[0056] The technical features of the embodiments described above 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.

[0057] The embodiments described above are merely examples 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 modifications and improvements all fall within the protection scope of this application.

Claims

1. An improved medical balloon device, characterized by, The balloon body is a hollow structure with opposite distal and proximal ends, and a conduit for delivering fluid into the balloon body is communicated at the proximal end of the balloon body. The reinforcing net is fixed on the outer periphery of the balloon body, and is formed by a single reinforcing wire arranged in a grid structure in rows and columns. The reinforcing wire is spirally wound on the outside of the balloon body, and has a relief structure along the extension path. The width of the wave crest is W1, and the width of the wave trough is W2, and W1:W2=1:1.2-6. The reinforcing net is fixed on the outer surface of the balloon body by bonding or hot melting.

2. The improved medical balloon device of claim 1, wherein, The balloon body includes an equal-diameter section in the middle and tapered reduced-diameter sections at both ends in the axial direction.

3. The improved medical balloon device of claim 1, wherein, The wave crest positions of adjacent two turns are directly opposite.

4. The improved medical balloon device of claim 3, wherein, In each cell, the first cell surrounded by the wave crest and the area is S1; the second cell surrounded by the wave trough and the area is S2; and S1+S2=4-20mm 2 .

5. The improved medical balloon device of claim 1, wherein, The reinforcing wire is twisted in single or multiple strands.

6. The improved medical balloon device of claim 1, wherein, The reinforcing wire is:

7. The improved medical balloon device of claim 1 wherein, a round wire with a diameter ranging from 50 to 200 μm, or a flat wire with a width of 100-300 μm and a thickness of 50-100 μm. In the reduced-diameter sections on both sides of the equal-diameter section, the reduced-diameter section at the distal end converges to a head end at the farthest end, and the reduced-diameter section at the proximal end converges to the conduit. The two ends of the single reinforcing wire extend and are fixed to the head end or the conduit respectively via the corresponding reduced-diameter section.

8. The improved medical balloon device of claim 3, wherein, ​

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