Medical balloon device

Abstract

The application relates to a medical balloon device, comprising: a balloon body which is a hollow structure and has opposite distal and proximal ends, a catheter for conveying fluid into the balloon body being communicated with the proximal end of the balloon body; and a reinforcing net which is spirally wound with a single reinforcing wire outside the balloon body, the reinforcing wire further having a relief structure with opposite crests and troughs during extension along the winding path, and the spiral winding is multiple turns, and in the adjacent two turns, the crests of one turn are wound with the troughs of the other turn.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a 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] The medical balloon device of this application includes:

[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] The reinforcing mesh is made of a single reinforcing wire 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 is wound in multiple turns, and in two adjacent turns, the peak of one turn and the trough of the other turn are intertwined.

[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 mesh is fixed to the outer surface of the balloon body by bonding or hot-melt.

[0012] Optionally, adjacent rings may form multiple cell structures, wherein the area of ​​each cell is 2–8 mm². 2 .

[0013] Optionally, the balloon body includes an equal-diameter section in the middle and tapered sections at both ends along the axial direction, wherein the number of cells in the circumferential direction of the balloon body in the equal-diameter section is 3 to 24.

[0014] Optionally, the number of cells in the circumferential direction of the bladder body can be 4 to 12.

[0015] Optionally, in three consecutive concentric circles, the peak positions of adjacent circles are staggered; the peak positions of alternating circles are aligned or staggered.

[0016] Optionally, the reinforcing yarn is twisted in a single strand or multiple strands.

[0017] Optionally, the balloon body has an axial direction extending from the distal end to the proximal end, the balloon body is strip-shaped and the length direction of the strip is consistent with the axial direction, each turn of the spiral winding extends approximately along the circumference of the balloon body, different turns are arranged sequentially along the axial direction, and the relative undulation direction of the crests and troughs is the axial direction of the balloon body.

[0018] Optionally, the balloon body has an axial direction extending from the distal end to the proximal end, the balloon body is strip-shaped and the length direction of the strip is consistent with the axial direction, each turn of the spiral winding is approximately back and forth along the axial direction of the balloon body, different turns are arranged along the circumferential direction of the balloon body, and the relative undulation direction of the crests and troughs is the circumferential direction of the balloon body.

[0019] 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.

[0020] The medical balloon device of this application balances the working strength and flexibility of the balloon body through improvements in the fiber weaving method. Attached Figure Description

[0021] Figure 1 This is a schematic diagram of the structure of a medical balloon device in one embodiment of this application;

[0022] Figure 2 This is a schematic diagram of the structure of the balloon body in one embodiment of this application;

[0023] Figure 3a This is a structural schematic diagram of the balloon body portion in one embodiment of the application;

[0024] Figures 3b-3c for Figure 3a A schematic diagram of the reinforcing mesh shown in the figure;

[0025] Figure 3d for Figure 3a Axial cross-sectional view;

[0026] Figure 4 This is a schematic diagram of the medical balloon device in one embodiment of the application;

[0027] Figure 5a This is a schematic diagram of the medical balloon device in one embodiment of the application;

[0028] Figure 5b for Figure 5a The diagram shows a schematic representation of the reinforcing mesh structure.

[0029] Figure 5c for Figure 5a Axial cross-sectional view;

[0030] The annotations in the figure are explained as follows:

[0031] 5. Catheter; 10. Balloon body; 10a. Isodiameter section; 10b. Narrow section; 11. Proximal end; 12. Distal end; 14. Reinforcing mesh; 15. Reinforcing wire; 16. Cell unit;

[0032] X1, point; L1, circumference of the sac; L2, circumferential span of the cell;

[0033] A1, First lap; A2, Second lap; A3, Third lap; B1, Peak; E1, Trough; B2, Peak; B3, Peak;

[0034] Y1, point; C1, first lap; C2, second lap; D1, peak; D2, trough. Detailed Implementation

[0035] 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.

[0036] 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.

[0037] 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.

[0038] 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.

[0039] 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.

[0040] 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.

[0041] 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.

[0042] See Figure 1 , Figure 2 , Figures 3a-3d This application provides a medical balloon device in one embodiment, 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 a single reinforcing wire spirally wound around the outside of the balloon body 10. The reinforcing wire has an undulating structure along its winding path, with relative peaks and troughs. The spiral is wound multiple times, with the peak of one turn intertwined with the trough of another in adjacent turns.

[0043] like Figure 3a As shown, the reinforcing mesh 14 is formed by winding a single reinforcing wire 15. The overall spiral winding trend is as follows: Figure 2 As shown, in the circumferential direction of the balloon body 10, the reinforcing wires tend to spirally wrap multiple times in the circumferential direction, without considering the mutual traction between them in the axial position. Combined with... Figure 2 and Figure 3b In the direction of spiral winding, each turn of the reinforcing wire forms a waveform in the axial direction, that is, forming relative peaks and troughs, with the peaks and troughs intertwined.

[0044] Taking the reinforcing wire 15 spirally wound in the circumferential direction as an example, see... Figure 3a The balloon body 10 is strip-shaped and the length direction of the strip is consistent with the axial direction. Each turn of the spiral extends approximately along the circumference of the balloon body 10. Different turns are arranged sequentially along the axial direction, and the relative undulation direction of the crests and troughs is the axial direction of the balloon body 10.

[0045] In this embodiment, among the reduced-diameter sections 10b on both sides of the equal-diameter section 10a, the reduced-diameter section 10b at the distal end 12 converges to one end of the farthest end 12, and the reduced-diameter 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 reduced-diameter sections 10b and are respectively fixed to the tip or the catheter 5. Figure 3aAs shown, reinforcing wires 15 extend from both ends of the balloon body 10.

[0046] Specifically, taking the reinforcing wire spirally wound in the circumferential direction as an example, such as... Figure 3a and 3b As shown, although point X1 is in a different loop in the diagram, in the actual product, the two points X1 at the outer periphery of the reinforcing mesh 14 coincide. For each loop of reinforcing wire, 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 distal end 12 is defined as the peak direction. Figure 3c As shown, the crests and troughs of two adjacent rings are intertwined. Taking the trough E1 of the first ring A1 and the crest B2 of the second ring A2 as an example, the first ring A1 and the second ring A2 pull each other in the axial direction, forming different rings of tension.

[0047] In this embodiment, a single reinforcing wire 15 (corresponding to multiple braided wires in the prior art) is woven from the distal end 12 (head end) of the balloon body to the proximal end 11. Adjacent loops are distributed on the outer surface of the balloon body 10 through intertwining of crests and troughs. The weaving method of the reinforcing wire 15 in this embodiment 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 of the medical balloon device at both ends and reducing the difficulty of interventional operations.

[0048] See Figure 3a The reinforcing mesh 14 is fixed to the outer surface of the balloon body 10 by bonding (e.g., using an adhesive of the type of polyurethane, the adhesive curing method can be natural curing or UV curing) or by hot melting.

[0049] See 3b. Adjacent rings form multiple cell structures, with cell 16 having an area of ​​2–8 mm². 2 In this embodiment, the shape of cell 16 is roughly rhomboid, with the four corners of the rhombus being the corresponding peaks and troughs that intertwine, thus making the cell structure relatively stable.

[0050] In use, see Figure 3a and Figure 3d When the medical balloon device is internally pressurized (by filling with fluid), the balloon body 10 bulges out. Because the elasticity of the reinforcing wire 15 is less than that of the balloon body 10, an uneven surface (i.e., protrusions) 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.

[0051] Traditional warp and weft weaving methods, however, struggle to balance the formation of bulges with the stability of cell sections.

[0052] For example, using a sparsely woven mesh (corresponding to the reinforcing mesh in various embodiments of this application) can easily lead to misalignment at the intersections of warp and weft threads due to a lack of mutual force. When the balloon bulges, the woven threads around each cell deform, causing severe deformation of the cell. The expansion of the cell causes the woven mesh at the deformed cell to lose its ability to restrain the balloon, reducing the load-bearing pressure and failing to achieve the expected effect, and even posing a safety hazard.

[0053] For example, using a dense mesh will result in relatively small cell areas (compared to a sparse mesh), making it difficult to form protrusions and thus reducing the effectiveness of the medical balloon device.

[0054] In this embodiment, the density of the cells is optimized; see [link to relevant documentation]. Figure 3b In the constant-diameter segment 10a, the number of circumferential cells 16 in the balloon body 10 ranges from 3 to 24. It can be understood that the narrower-diameter segment 10b has a smaller circumferential unfolding length than the constant-diameter segment 10a, so the number of cells 16 in the narrower-diameter segment 10b will not be explained. Furthermore, the number of circumferential cells 16 in the balloon body 10 ranges from 4 to 12. The fewer the number of cells, the smaller the diameter of the folded balloon.

[0055] As shown in the figure, the circumference of the balloon body 10 is L1, and the span of cell 16 along the circumference of the balloon body 10 is L2. L1 is 3 to 24 times L2. For example... Figure 3a and Figure 4 The different span ratios shown are reflected in the different cell sizes, as can be seen in the image. Figure 4 The cell ratio Figure 3a Larger. Furthermore, L1 is 4 to 12 times larger than L2.

[0056] See Figure 3c In a continuous arrangement of three loops, the crest positions of adjacent loops are staggered; the crest positions of alternating loops are aligned or staggered. Taking a reinforcing wire spirally wound in the circumferential direction as an example, the first loop A1, the second loop A2, and the third loop A3 are three consecutive loops of reinforcing wire. The first loop A1 and the second loop A2 are adjacent, and the crest B1 of the first loop A1 and the crest B2 of the second loop A2 are staggered. Taking alternating loops with aligned crest positions as an example, the first loop A1 and the third loop A3 are alternating, and the crest B1 of the first loop A1 and the crest B3 of the third loop A3 are aligned. In one embodiment, see... Figures 5a-5c The reinforcing wire is spirally wound in the axial direction. The balloon body 10 has an axial direction extending from the distal end 12 to the proximal end 11. The balloon body 10 is strip-shaped and the length direction of the strip is consistent with the axial direction. Each turn in the spiral winding is roughly back and forth along the axial direction of the balloon body 10. Different turns are arranged circumferentially between the balloon body 10. The relative undulation direction of the crests and troughs is circumferentially of the balloon body 10.

[0057] like Figure 5b As shown, although point Y1 on reinforcing wire 15 is in different loops in the diagram, in the actual product, after the reinforcing mesh 14 is coiled and wound around the outer circumference of the balloon body 10, point Y1 at the two locations coincides. That is, each loop of reinforcing wire travels back and forth along the axial direction and circumferentially. Taking the first loop C1 and the second loop C2 as examples, the first loop C1 and the second loop C2 are two adjacent loops of reinforcing wire. The peak D1 of the first loop C1 and the trough D2 of the second loop C2 are intertwined. It can be understood that after each loop is spirally wound, it forms a shape like... Figure 5a The reinforcing mesh 14 shown above forms a structure as follows: Figure 5c The reinforcement mesh 15 and the balloon body 10 are shown in the diagram. The reinforcement mesh is composed of a single reinforcing wire 15, which extends to both ends of the balloon body 10.

[0058] In one embodiment, the reinforcing filament is prepared by single-strand or multi-strand twisting. The reinforcing filament can be round or flat. 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 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.

[0059] The reinforcing mesh of the product in this application can be implemented using existing technologies, for example, in terms of its processing method. Figure 3a The middle can be formed using a method similar to weft knitting; or for example... Figure 5a The middle uses a similar technique to weft knitting (relative to) Figure 3a It is formed by the interchange of latitude and longitude directions.

[0060] When the balloon body 10 is pressurized to 40 atm, the height of the cell protrusion ranges from 0 to 1 mm. Furthermore, when the balloon body 10 is pressurized to 40 atm and the number of circumferential grids is 8, the cell protrusion of the balloon body 10 after pressurization is 0.5 mm.

[0061] 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. In the embodiments of this application, 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.

[0062] 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.

[0063] 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. A medical balloon device, characterized in that, include: 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; The reinforcing mesh consists of a single reinforcing wire spirally wound around the outside of the balloon body. As the reinforcing wire extends along its winding path, it exhibits an undulating structure with relative peaks and troughs. The elasticity of the reinforcing wire is less than that of the balloon body. When the balloon body is pressurized and bulges, uniformly distributed protrusions form on the outer surface of the balloon body. The spiral winding consists of multiple turns, with multiple cell structures formed between adjacent turns. Each protrusion represents a cell position. In adjacent turns, the peak of one turn intertwines with the trough of the other.

2. The medical balloon device according to claim 1, characterized in that, The reinforcing wire extends and is fixed at both ends of the balloon body.

3. The medical balloon device according to claim 1, characterized in that, The reinforcing mesh is fixed to the outer surface of the balloon body by bonding or hot-melt.

4. The medical balloon device according to claim 1, characterized in that, The area of ​​the cell is 2-8 mm². 2 .

5. The medical balloon device according to claim 4, characterized in that, 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, the number of cells in the circumferential direction of the balloon body is 3 to 24.

6. The medical balloon device according to claim 5, characterized in that, The number of cells in the circumferential direction of the balloon body is 4 to 12.

7. The medical balloon device according to claim 5, characterized in that, Of 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 head end or the conduit after passing through the corresponding reduced diameter sections.

8. The medical balloon device according to claim 1, characterized in that, In three consecutive concentric circles, the peak positions of adjacent circles are staggered; the peak positions of alternating circles are aligned or staggered.

9. The medical balloon device according to claim 1, characterized in that, The reinforcing wire is twisted in a single strand or multiple strands.

10. The medical balloon device according to claim 1, characterized in that, The balloon body has an axial direction extending from the distal end to the proximal end, and the balloon body is strip-shaped with the length direction of the strip aligned with the axial direction of the balloon body; Each turn of the spiral winding extends approximately along the circumference of the balloon body, and different turns are arranged sequentially along the axial direction of the balloon body. The relative undulation direction of the crests and troughs is the axial direction of the balloon body. Alternatively, each turn in the spiral winding is approximately axially reciprocating along the balloon body, with different turns arranged circumferentially along the balloon body, and the relative undulation direction of the crests and troughs being circumferential along the balloon body.

11. The medical balloon device according to claim 1, characterized in that, The circumference of the balloon body is L1, and the span of the cell in the circumferential direction of the balloon body is L2, where L1 is 3 to 24 times L2.

12. The medical balloon device according to claim 1, characterized in that, When the balloon body is pressurized to 40 atm, the height of the protrusion of the cell ranges from 0 to 1 mm; When the number of cells in the circumferential direction of the balloon body is 8, the cells protrude 0.5 mm when the balloon body is pressurized to 40 atm.

13. The medical balloon device according to claim 1, characterized in that, The reinforcing filament is made of a flexible biomedical polymer material selected from nylon, polyether block polyamide, polytetrafluoroethylene, or polyethylene.

14. The medical balloon device according to claim 1, characterized in that, The axial length of the balloon is 15cm and the diameter is 6mm. Under the action of the reinforcing mesh, the maximum burst pressure of the balloon reaches 40atm.

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