A sawtooth member, a sawtooth balloon, and a sawtooth member manufacturing method

Abstract

This invention discloses a serrated component, a serrated balloon, and a method for manufacturing the serrated component, belonging to the field of medical device technology. The serrated component includes a strip that can be bonded to the outer surface of a balloon by an adhesive layer. The strip has serrations spaced along its length. The end region of the strip has an adhesive reinforcement end with an embedding groove for embedding the adhesive layer. The serrated balloon includes a balloon and the serrated component. The length direction of the strip of the serrated component is arranged along the axial direction of the balloon. The strip is connected to the balloon by a connecting structure, which includes at least an adhesive layer. The method for manufacturing the serrated component includes the following steps: plastically processing the end region of the serrated strip to form an adhesive reinforcement end with an embedding groove for embedding into the adhesive layer on the outer surface of the balloon. This effectively avoids the main failure mode of serrated components—end warping—which can cause the entire serrated component to detach.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a serrated component, a serrated balloon, and a method for manufacturing the serrated component. Background Technology

[0002] Atherosclerosis is a non-inflammatory arterial disease closely associated with serious cardiovascular diseases such as coronary heart disease, myocardial infarction, and cerebral infarction. Its pathological characteristic is the formation of a layer of hard plaque along the arterial wall, mainly composed of calcium, cholesterol, compacted thrombi, and cellular debris. As the disease progresses, the arteries gradually narrow or even become blocked due to plaque accumulation, leading to obstructed blood flow and subsequently inducing the aforementioned serious complications.

[0003] Balloon angioplasty is one of the most commonly used interventional techniques for treating atherosclerotic stenosis in clinical practice. Its basic principle is to advance a balloon catheter to the site of the stenotic lesion, and then inflate the balloon under high pressure, applying radial force to the plaque, causing it to stretch, compress, or even rupture, thereby restoring vascular patency. However, because atherosclerotic plaques typically have heterogeneous structural characteristics, conventional balloons are prone to random plaque rupture during high-pressure inflation, leading to uncontrollable damage to the vascular intima and vascular dissection, increasing the risk of restenosis after the procedure.

[0004] To address these issues, various improved balloon techniques have been developed, such as the spinous process balloon, the notched balloon, and the chocolate balloon. These balloons are designed to reduce the working pressure required for balloon expansion through localized stress concentration, thereby improving their ability to target and destroy plaques. Additionally, some balloons employ serrated structures with blades, using notches to guide plaque rupture along a predetermined path, thus better controlling the extent of damage to the vessel wall.

[0005] However, a significant technical challenge remains for serrated balloons used in long lesion segments: because the elongation of the serrated component material is lower than that of the balloon body material, during high-pressure inflation, as the difference in elongation increases, the serrated component is prone to detaching from the balloon surface, posing a potential risk of debris remaining inside the balloon. Further research indicates that during repeated use or insertion / extraction of the sheath, detachment of the serrated component typically begins in its distal region. Therefore, special design for this area is necessary to enhance local adhesion and improve the overall safety and reliability of the balloon. Current solutions to this problem often involve using lower inflation pressure, sacrificing some of the balloon's plaque-handling capacity in exchange for the stability of the serrated component, thereby ensuring safe use.

[0006] Therefore, there is an urgent need for an improved solution that can effectively solve the problem of the saw teeth detaching at the end while ensuring the balloon plaque treatment capacity. Summary of the Invention

[0007] The purpose of this invention is to solve the above-mentioned technical problems and provide a serrated component, a serrated balloon, and a method for manufacturing the serrated component. Under the action of the adhesive reinforcement end of the serrated component, the main failure mode of the serrated component - end lifting - can be effectively avoided, which causes the entire serrated component to fall off (especially in the case of repeated entry and exit from the sheath).

[0008] To achieve the above objectives, the present invention provides the following solution: The present invention discloses a serrated component, comprising a strip that can be bonded to the outer surface of a balloon by an adhesive layer, the strip having serrations arranged at intervals along its length direction, the end side region of the strip having an adhesive reinforcement end, the adhesive reinforcement end having an embedding groove for embedding the adhesive layer.

[0009] In one embodiment, the end regions at both ends of the strip are provided with adhesive-reinforced ends.

[0010] In one embodiment, the adhesive-reinforced end is formed by plastic processing of the end-side region of the strip.

[0011] In one embodiment, the number of serrations on the adhesive reinforcement end is 1 to 6.

[0012] In one embodiment, the number of serrations on the adhesive reinforcement end is 2 to 4.

[0013] In one embodiment, the adhesive reinforcement end is a wavy linear structure formed by bending, and the crests and troughs of the adhesive reinforcement end both constitute the embedding groove. The bending direction is perpendicular to both the length direction of the strip and the side of the serration.

[0014] In one embodiment, the bending radius of the adhesive-reinforced end is r = l / π, where l is the distance between two adjacent saw teeth.

[0015] In one embodiment, the adhesive reinforcement end is formed by twisting the end of the strip, with a twist angle less than or equal to 135°, and the gap between any two adjacent serrations on the adhesive reinforcement end forms the embedding groove.

[0016] In one embodiment, the torsion angle is less than or equal to 100°.

[0017] In one embodiment, the torsion angle is less than or equal to 90°.

[0018] In one embodiment, the serrations on the adhesive reinforcement end have different serration orientations from the serrations in the middle region of the strip, and the gap between any two adjacent serrations on the adhesive reinforcement end forms the embedding groove.

[0019] In one embodiment, one or more serrations on the adhesive reinforcement end have a different serration orientation than the serrations on the central region of the strip.

[0020] In one embodiment, the 2 to 6 serrations on the adhesive reinforcement end have a different serration orientation than the serrations on the central region of the strip.

[0021] In one embodiment, in the projection along the length of the strip, the serrations on the adhesive reinforcement end form an angle with the serrations in the middle region of the strip, the angle being less than or equal to 135°.

[0022] In one embodiment, in the projection along the length of the strip, the serrations on the adhesive reinforcement end form an angle with the serrations in the middle region of the strip, the angle being less than or equal to 100°.

[0023] In one embodiment, in the projection along the length of the strip, the serrations on the adhesive-reinforced end form an angle with the serrations in the middle region of the strip, the angle being less than or equal to 90°.

[0024] The present invention also discloses a serrated balloon, comprising a balloon and serrated members arranged at circumferential intervals along the outer surface of the balloon as described above. The length direction of the strips of the serrated members is arranged along the axial direction of the balloon, and the strips are connected to the balloon by a connecting structure, the connecting structure including at least the adhesive layer.

[0025] In one embodiment, the adhesive layer includes a bottom layer adhesive, a middle layer adhesive, and a top layer adhesive. The bottom layer adhesive is disposed on the outer surface of the balloon, the middle layer adhesive is disposed on the outer surface of the bottom layer adhesive, the strip is embedded in the middle layer adhesive, and the top layer adhesive covers the strip on the middle layer adhesive.

[0026] In one embodiment, the bottom adhesive, the middle adhesive, and the top adhesive are all UV adhesives.

[0027] In one embodiment, the thickness of the bottom layer adhesive is 0.02mm to 0.06mm, the thickness of the middle layer adhesive is 0.1mm to 0.15mm, and the thickness of the top layer adhesive is 0.02mm to 0.06mm.

[0028] In one embodiment, the middle layer adhesive is located at the middle position of the bottom layer adhesive in the width direction, the width of the bottom layer adhesive is w1=w0+0.6mm~1mm, and the width of the middle layer adhesive is w2=w0+0.2mm~0.6mm, where w0 is the width of the strip.

[0029] In one embodiment, the connection structure further includes a braided layer that binds the strip to the balloon.

[0030] In one embodiment, the braided layer includes a densely woven area and a loosely woven area, the loosely woven area being located in the region corresponding to the serrations on the strip, and the densely woven area being located in the region corresponding to the gap between two adjacent serrations on the strip.

[0031] In one embodiment, the braided layer is located outside the adhesive layer.

[0032] In one embodiment, the braided layer uses elastic yarns for its braiding.

[0033] The present invention also discloses a method for manufacturing a serrated part, comprising the following steps: plastically processing the end side region of a strip with serrations to form an adhesive-reinforced end with an embedding groove, wherein the embedding groove is used to embed into the adhesive layer on the outer surface of the balloon.

[0034] In one embodiment, the plastic processing includes bending or twisting; the bending process is used to bend the adhesive reinforcement end into a wavy structure, wherein the crests and troughs of the adhesive reinforcement end constitute the embedding groove; the twisting process is used to twist the end of the strip to form the adhesive reinforcement end, wherein any two adjacent serrations on the adhesive reinforcement end constitute the embedding groove, and the twist angle is less than or equal to 135°.

[0035] In one embodiment, the embedded groove is formed between any two adjacent serrations on the adhesive reinforcement end, with a torsion angle less than or equal to 100°.

[0036] In one embodiment, the embedded groove is formed between any two adjacent serrations on the adhesive reinforcement end, with a torsion angle less than or equal to 90°.

[0037] The present invention achieves the following technical effects compared to the prior art: In this invention, the end region of the serrated component is provided with an adhesive reinforcement end, which has an embedding groove. After the embedding groove is embedded in the adhesive layer on the outer surface of the balloon, it can increase the contact area between the end of the strip and the adhesive layer. On the other hand, the embedding groove and the adhesive layer can generate resistance and resist deformation by interlocking with each other, which greatly strengthens the adhesive force of the end of the strip, making the end of the strip less likely to detach. This can effectively avoid the main failure mode of the serrated component - end lifting, which causes the entire serrated component to fall off (especially in the case of repeated entry and exit from the sheath).

[0038] Other technical solutions of the present invention have achieved the following technical effects compared with the prior art: 1. This invention employs a three-layer adhesive process. The bottom layer adhesive primarily serves as a foundation, providing adhesion for the middle layer adhesive. The middle layer adhesive is the main component for fixing the saw teeth. It forms an arched adhesion pattern along the surface of the saw teeth. During curing, most of the middle layer adhesive covers the strips of the saw teeth, thus forming a deformation-resistant structure similar to reinforced concrete in the construction industry. This reduces the difference in elongation between the saw teeth and the bladder, preventing the saw teeth from detaching. The top layer adhesive fills any defects that may exist in the middle layer adhesive during the molding process, allowing the middle layer adhesive and the saw teeth to better form a unified whole.

[0039] 2. In this invention, a braided layer is added. With the combined action of the adhesive layer, the bonding reinforcement end, and the braided layer, the serrated balloon can maintain a high pressure state (15 atm~25 atm) during operation, thereby making it more effective at destroying plaques and achieving better clinical results.

[0040] 3. In this invention, after bonding is completed, a braided layer is placed over the outside of the serrated component and the balloon. This creates a weak connection between the braided layer, the serrated component, and the balloon, which is in a free state. This weak connection allows the braided layer to dynamically adjust itself when the serrated component undergoes large deformation in tortuous lesion areas. This avoids the situation where a large deformation of the serrated component would cut the braided fibers, as is the case with a fixed connection (strong connection). This is a special technology to protect the braided layer, ensuring the stability of the connection. Moreover, as long as the braided layer is intact, even if the serrated component breaks accidentally, it can still be safely removed from the body with the balloon as the balloon is withdrawn, forming an additional double layer of safety protection.

[0041] 4. The serrated balloon of this invention can achieve a RBP (maximum burst pressure) of 22 atm or higher, solving the problem that existing products on the market cannot dilate complex and refractory lesions. The serrated balloon of this invention is intended to be suitable for dilating lesions in the iliac artery, femoral artery, iliofemoral artery, popliteal artery, subpopliteal artery, and renal artery, and for treating obstructive lesions in autologous or artificial arteriovenous dialysis fistulas; it can effectively address fibrosis and rigid stenosis, improving the success rate of dilation while reducing the risk of balloon rupture; it can precisely focus on the lesion without involving surrounding normal blood vessels, reducing the risk of vascular damage and restenosis. Attached Figure Description

[0042] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained by analyzing these drawings without creative effort.

[0043] Figure 1This is a three-dimensional structural diagram of the sawtooth component (after bending) in an embodiment of the present invention; Figure 2 This is a front view of the sawtooth component (after bending) in an embodiment of the present invention. Figure 3 This is a top view of the sawtooth component (after bending) in an embodiment of the present invention; Figure 4 This is a three-dimensional structural diagram of the adhesive reinforcement end of the sawtooth component in an embodiment of the present invention; Figure 5 This is a three-dimensional structural diagram of the sawtooth component (after torsion processing) in an embodiment of the present invention; Figure 6 This is a three-dimensional structural diagram of the serrated balloon (without braided layer) in an embodiment of the present invention; Figure 7 This is a front view structural diagram of the serrated balloon (without braided layer) in an embodiment of the present invention; Figure 8 This is a front view structural diagram of the serrated balloon (without braided layer) in an embodiment of the present invention; Figure 9 for Figure 8 A magnified schematic diagram of the distal part of the serrated balloon; Figure 10 for Figure 9 A magnified schematic diagram of the distal part of the serrated balloon; Figure 11 This is a front view structural diagram of the serrated balloon (including the braided layer) in an embodiment of the present invention; Figure 12 This is a schematic diagram of the structural relationship between the braided layer and the serrated part in an embodiment of the present invention; Figure 13 This is a three-dimensional structural diagram of the sawtooth component (integrated cutting process) in an embodiment of the present invention; Figure 14 This is a schematic diagram showing the included angle between the middle saw teeth and the end saw teeth of the saw tooth component (integral cutting processing) in an embodiment of the present invention; Figure 15 This is a schematic diagram of the peripheral serrated balloon dilation catheter structure in an embodiment of the present invention; Figure 16 for Figure 15 A picture of a woven balloon; Figure 17 for Figure 16 A magnified view of the central area of ​​the woven balloon; Figure 18 for Figure 16 A magnified view of the distal region of the woven balloon.

[0044] Explanation of reference numerals in the attached figures: 1. Serrated component; 2. Balloon; 3. Rubber layer; 4. Braided layer; 11. Strip; 12. Serrated; 13. Adhesive-reinforced end; 14. Embedded groove; 31. Bottom layer adhesive; 32. Middle layer adhesive; 33. Top layer adhesive; 41. Densely woven area; 42. Loosely woven area; 111. Proximal region; 112. Middle region; 113. Distal region; 123. Sawtooth end face; 124. Sawtooth root; 141. Included angle; 101. Terminal end; 102. Contrast ring; 103. Braided balloon; 104. Inner tube; 105. Double-lumen tube; 106. Reinforcing tube; 107. Catheter hub; L1, effective length of balloon; L2, effective length of catheter; L3, length of serrated part; D, diameter of balloon after inflation; d1, outer diameter of double lumen tube. Detailed Implementation

[0045] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments analyzed and obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0046] The purpose of this invention is to provide a serrated component, a serrated balloon, and a method for manufacturing the serrated component, such as... Figures 1 to 18 As shown, in order to solve the problems existing in the prior art, the end side area of ​​the saw tooth has an adhesive reinforcement end, and the adhesive reinforcement end is provided with an embedding groove. After the embedding groove is embedded in the adhesive layer on the outer surface of the balloon, it can effectively avoid the main failure mode of the saw tooth - end lifting, which causes the entire saw tooth to fall off (especially in the case of multiple insertion and exit from the sheath).

[0047] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0048] Note: The proximal end mentioned throughout the text refers to the end closer to the caster, while the distal end refers to the end farther away from the caster.

[0049] Example 1 like Figures 1 to 12As shown, this embodiment provides a serrated component, including a strip 11, which can be bonded to the outer surface of the balloon 2 by an adhesive layer 3. The strip 11 has serrations 12, which are spaced apart along the length of the strip 11. The end region of the strip 11 (at least near the proximal end of the balloon 2) has an adhesive reinforcement end 13; that is, the strip 11 may have an adhesive reinforcement end 13 only at the proximal end, or it may have adhesive reinforcement ends 13 at both the distal and proximal ends. The adhesive-reinforced end 13 has an embedding groove 14 for embedding the adhesive layer 3. Adhesive is filled into the embedding groove 14 to form an additional contact area of ​​the adhesive layer 3 between the strip 11 and the original contact area of ​​the adhesive layer 3. On the one hand, this increases the contact area between the end of the strip 11 and the adhesive layer 3. On the other hand, the interlocking of the embedding groove 14 and the adhesive layer 3 can also generate resistance to deformation, greatly strengthening the adhesive force of the end of the strip 11. This makes the end of the strip 11 less likely to detach, reducing the probability of the main failure mode (detachment from the end of the strip 11). While adhesive reinforcement end 13 can be provided at the proximal end of strip 11, adhesive reinforcement end 13 can also be provided at the distal end of strip 11. However, its necessity is not significant because detachment always starts from the proximal end of strip 11 (serrated part 1). This is because balloon 2 only expands and serrated part 1 experiences resistance during plaque rupture. The proximal end of strip 11 (serrated part 1) is the part that first experiences resistance, and it is also the part where resistance is more concentrated. Therefore, providing adhesive reinforcement end 13 at the distal end of strip 11 is possible, but not very necessary. Furthermore, plastic processing may affect the function of serration 12. Therefore, providing adhesive reinforcement end 13 at the distal end of strip 11 will reduce the number of serrations 12 that are functioning in strip 11 as a whole. Apart from the adhesive-reinforced end 13 being machined from the sawtooth part 1, the rest of the sawtooth part 1 is an existing structure. Therefore, the number and spacing of its sawtooth 12 are standard specifications, and the shape of the sawtooth 12 is a standard shape, which will not be elaborated on here.

[0050] In one embodiment of this example, adhesive-reinforced ends 13 are provided at both the proximal and distal ends of the strip 11.

[0051] In one embodiment of this invention, the number of serrations 12 on the bonded reinforcing end 13 is 1 to 6 (preferably 2 to 4). Because the bonded reinforcing end 13 is directly machined from the strip 11, the scoring function of the serrations 12 may be affected during the plastic forming process, causing the serrations 12 to lose their original scoring function. Thus, for serration parts 1 of the same specifications, the number of serrations 12 that perform the scoring function after plastic forming of the bonded reinforcing end 13 will be reduced compared to serration parts 1 that have not undergone processing. Therefore, to ensure the cutting effect, the number of serrations 12 on the bonded reinforcing end 13 should not exceed three, preferably two. For example, for a short-sized serration part 1, the number of serrations 12 may only be 25. Excessive use of serrations 12 at the end will significantly reduce the effective scoring length.

[0052] In one embodiment of this invention, the adhesive-reinforced end 13 is directly formed by plastic processing on the end of the original strip 11. The adhesive-reinforced end 13 is processed from the original serrated part 1 and belongs to the original structure of the serrated part 1, so it has strong integrity and can ensure the structural strength of the serrated part 1.

[0053] In one embodiment of this invention, the adhesive reinforcement end 13 is a wavy linear structure formed by bending (e.g., press bending) (see reference). Figures 1 to 4 As shown, the crests and troughs on the adhesive reinforcement end 13 form embedded grooves 14, with the bending direction perpendicular to the length direction of the strip 11 and the side of the serration 12. The adhesive reinforcement end 13 is processed into a wavy line structure, which changes the original two-dimensional structure of the strip 11 into a three-dimensional spatial structure, thereby greatly strengthening the adhesive force at the end of the serration 1.

[0054] In one embodiment of this invention, the radius of the wave is determined based on the spacing of the saw teeth 12, one parameter being the bending radius r = l / π of the bonded reinforcement end 13. Here, l is the spacing between two adjacent saw teeth (12). This parameter serves as a reference, its purpose being to match the spacing of the saw teeth 12, ensuring that there is always a bending angle between the two saw teeth 12. It can be fine-tuned; increasing it expands the overall bending beyond the centerline of the two saw teeth 12, while decreasing it shrinks it within the centerline of the two saw teeth 12. Aligning it precisely with the centerline of the two saw teeth 12 is a preferred implementation, but it is not mandatory.

[0055] In one embodiment of this invention, the adhesive reinforcement end 13 is formed by twisting the end of the strip 11 (see reference). Figure 5As shown), the torsion angle is less than or equal to 135° (or less than or equal to 100°; or less than or equal to 90°), and an embedding groove 14 is formed between any two adjacent serrations 12 on the adhesive reinforcing end 13. In this way, compared to forming a wavy line structure, the adhesive reinforcing end 13 can be completely embedded in the adhesive layer 3, thereby greatly improving the end (proximal end) of the serrated part 1's resistance to detachment and warping. Experiments have shown that under the same conditions, under fatigue bursts of 20 atm (short for atmosphere, referring to the standard atmospheric pressure at sea level on Earth), the ends of the original untreated strip 11 will bulge and warp. However, the adhesive-reinforced end 13 formed by the torsion process expands the adhesive force of the end face (the original structure is a strip structure, and after torsion, its effective cross-section is a small rectangular cross-section, which is equivalent to greatly increasing the contact area with the colloid within the same volume). On the other hand, it forms a spatial pre-embedded adhesive pressing capability (forming a three-dimensional embedding groove 14 embedded in the colloid, thereby increasing the adhesion to the colloid).

[0056] In one embodiment of this invention, the sawtooth component 1 is typically a metal component.

[0057] Example 2 like Figure 13 and Figure 14 As shown, this embodiment provides a serrated part. Unlike the serrated part 1 in Embodiment 1, the adhesive reinforcement end 13 of the serrated part 1 in this embodiment is not directly formed by plastic processing on the end of the original strip 11. Instead, a lateral protrusion (or lateral groove) is integrally cut into the end of the original strip 11 to form an adhesive reinforcement end 13 with an embedded groove 14. The shape and structure of the lateral protrusion can be consistent with the serration 12 on the middle region 112 of the strip 11 of the serrated part 1 (e.g., ...). Figure 13 As shown, the shape and structure of the serrations 12 at the ends are consistent with those of the serrations 12 in the middle region 112; the shape and structure of the lateral protrusions may also be inconsistent with those of the serrations 12 in the middle region 112 of the strip 11 of the serrated member 1. The shape and structure of the lateral grooves may be consistent with the groove shape between the two serrations 12 in the middle region 112 of the serrated member 1 (e.g., ...). Figure 13 The shape and structure of the lateral grooves can also differ from the groove shape between any two serrations 12 on the central region 112 of the strip 11. Regardless of how the lateral protrusions (or lateral grooves) are arranged, they are all designed to enhance the bonding strength between the end of the strip 11 and the surface of the balloon 2. For example, in some embodiments, the serrated member 1 includes a strip 11 that can be glued to the outer surface of the balloon, and the strip 11 has serrations 12 spaced along its length; the end region (e.g., Figure 13The serrations (e.g., on the proximal region 111 or the distal region 113 and middle region 112 of the strip 11 shown) are as follows. Figure 13 The serrations 12 at the ends shown and the middle region 112 of the strip 11 (e.g.) Figure 13 The serrations 12 on the central region 112 shown are as follows: Figure 13 The serrations 12 shown have different serration orientations (serration orientation refers to the direction from the serration root 124 to the serration end face 123) to form an adhesive-reinforced end 13. Further, one or more serrations 12 on the end region of the strip have different serration orientations than the serrations 12 on the middle region 112 of the strip 11 to form an adhesive-reinforced end 13. Further, the serrations 12 on the end region of the strip 11 have different serration orientations than the serrations 12 on the middle region 112 of the strip 11 to form an adhesive-reinforced end 13 with an insert groove 14. Further, two to six serrations 12 on the end region of the strip 11 have different serration orientations than the serrations 12 on the middle region 112 of the strip 11 to form an adhesive-reinforced end 13 with an insert groove 14.

[0058] In some embodiments, along the length direction of strip 11 (e.g.) Figure 13 The projection (as shown by the arrow direction) Figure 13 In the lower left portion (projecting the sawtooth 12 at the end onto the projection plane of the sawtooth 12 in the direction of the arrow), there is an angle 141 between the sawtooth 12 on the end region of the strip 11 and the sawtooth 12 on the middle region 112 of the strip 11, and the angle 141 is less than or equal to 135°. Further, in a projection parallel to the length direction of the strip 11, there is an angle 141 between the sawtooth 12 on the end region of the strip 11 and the sawtooth 12 on the middle region 112 of the strip 11, and the angle 141 is less than or equal to 135°. Further, in a projection parallel to the length direction of the strip 11, there is an angle 141 between the sawtooth 12 on the end region of the strip 11 and the sawtooth 12 on the middle region 112 of the strip 11, and the angle 141 is less than or equal to 100°. Furthermore, in a projection parallel to the length direction of the strip, the saw teeth on the end region of the strip and the saw teeth on the middle region 112 of the strip form an angle 141, the angle 141 being less than or equal to 90°.

[0059] Example 3 like Figures 1 to 13As shown, this embodiment provides a serrated balloon, including a balloon 2 and serrated components 1 as in Embodiment 1 or Embodiment 2. The serrated components 1 are spaced circumferentially along the outer surface of the balloon 2. The length direction of the strips 11 of the serrated components 1 is along the axial direction of the balloon 2. The strips 11 are connected to the balloon 2 via a connecting structure, which includes at least an adhesive layer 3. That is, the strips 11 are connected to the balloon 2 at least via the adhesive layer 3. The number of serrated components 1 is set as needed, typically at least two. Preferably, multiple serrated components 1 are evenly spaced on the balloon 2. Of course, the spacing between any two adjacent serrations 12 in a local area can be adjusted as needed; that is, uniform spacing is not necessarily required. Figures 5 to 7 As shown, the balloon 2 is provided with three evenly spaced serrated parts 1.

[0060] In one embodiment of this invention, the adhesive layer 3 employs a three-layer adhesive bonding process to connect the sawtooth component 1 and the balloon 2 into a single unit. Specifically, the adhesive layer 3 includes a bottom layer adhesive 31, a middle layer adhesive 32, and a top layer adhesive 33. The bottom layer adhesive 31 is applied to the outer surface of the balloon 2 and, after curing, forms a unified structure with the surface of the balloon 2. The bottom layer adhesive 31 primarily acts as a foundation, providing adhesion for the middle layer adhesive 32; therefore, the bottom layer adhesive 31 typically has a large coverage area and a relatively thin thickness. The middle layer adhesive 32 is applied to the outer surface of the bottom layer adhesive 31 and forms the main part for fixing the sawtooth component 1. Therefore, the strip 11 needs to be embedded (embedded) in the middle layer adhesive 32. Due to the viscosity of the adhesive, when the sawtooth component 1 is pressed down, the middle layer adhesive 32 forms an arched adhesion pattern along the surface of the sawtooth component 1. During curing, most of the middle layer adhesive 32 covers the strip 11 of the sawtooth component 1, thus forming a deformation-resistant structure (similar to reinforced concrete structures in the construction industry). Top layer adhesive 33 is used to cover strip 11 on middle layer adhesive 32. Its important function is to fill the defects that may exist in the middle layer adhesive 32 during the molding process: that is, due to the fluidity, the upper part of strip 11 fails to form the colloid fusion pattern on both sides in time before curing, resulting in strip 11 not being completely embedded in some areas and insufficient adhesion. The addition of top layer adhesive 33 can effectively make up for this defect, so that the middle layer adhesive 32 and the sawtooth part 1 form a whole, greatly improving the adhesion and reducing the risk of strip 11 and balloon 2 detaching.

[0061] In one embodiment of this example, the bottom adhesive 31, the middle adhesive 32, and the top adhesive 33 are all UV adhesives (also known as ultraviolet light curing adhesives), which need to be cured in conjunction with a UV lamp (usually ultraviolet light, etc.).

[0062] In one embodiment of this example, the bottom adhesive 31, the middle adhesive 32, and the top adhesive 33 are bonded using a spray adhesive bonding process.

[0063] In one embodiment of this example, the thickness of the bottom adhesive 31 is 0.02mm~0.06mm, the thickness of the middle adhesive 32 is 0.1mm~0.15mm, and the thickness of the top adhesive 33 is 0.02mm~0.06mm.

[0064] In one embodiment of this example, the middle layer adhesive 32 is located at the middle position of the bottom layer adhesive 31 in the width direction. The width of the bottom layer adhesive 31 needs to be determined according to the width of the sawtooth part 1. Therefore, the width of the bottom layer adhesive 31 is w1 = w0 + 0.6mm~1mm, where w0 is the width of the strip 11, i.e., the width of the strip 11 + 0.3mm~0.5mm of the adhesive on both sides. The middle layer adhesive 32 needs to produce a gathering effect, so the width of the middle layer adhesive 32 is the width of the strip 11, which is w2 = w0 + 0.2mm~0.6mm, where w0 is the width of the strip 11, i.e., the width of the strip 11 + 0.1mm~0.3mm of the adhesive on both sides. The top layer adhesive 33 will diffuse, so the top layer adhesive 33 has no specific width requirement and can be the same width as the middle layer adhesive 32.

[0065] In one embodiment of this invention, the connection structure further includes a braided layer 4 (reference). Figure 11 As shown, the braided layer 4 binds the strip 11 to the balloon 2. The adhesive layer 3 alone can only guarantee scoring under balloon 2 pressure of 12 atm to 14 atm. However, pressures exceeding 14 atm will still cause the serrated part 1 to detach. Therefore, by adding the braided layer 4 and using it for binding, the connection stability with the balloon 2 can be significantly improved. It has been verified that with the addition of the braided layer 4, scoring can withstand balloon 2 pressures of 15 atm to 25 atm.

[0066] In one embodiment of this invention, the braided layer 4 employs special braiding parameters, which, in conjunction with the tooth gap of the sawtooth 12 of the sawtooth component 1, form a braided structure with varying density, as follows: Figure 12 As shown: the braided layer 4 includes a densely woven area 41 and a loosely woven area 42. The loosely woven area 42 is located in the region corresponding to the serrations 12 on the strip 11, and the densely woven area 41 is located in the region corresponding to the gap between two adjacent serrations 12 on the strip 11. That is, the main fixing area is at the distance between any two serrations 12 on the strip 11. A high-density braiding method is used to form the densely woven area 41, making the fixing of the serration component 1 more secure. In the working area of ​​the serration component 1 (the position of the serration 12), a loosely woven method is used, so that the braided yarns can automatically slide down at the position of the serration 12, preventing the scoring function of the serration 12 from being affected by the braiding. Through this method, not only is the stable connection of the serration component 1 guaranteed, but the problem of the scoring function area (serration 12) of the serration component 1 being affected by the braided layer 4 is also solved.

[0067] In one embodiment of this invention, the braided layer 4 is located outside the adhesive layer 3. That is, the braided layer 4 of this serrated balloon is woven on after the serrated component 1 is completely bonded to the balloon 2. The braided layer 4 is in a free state with the balloon 2 and the serrated component 1, rather than being embedded in the adhesive layer 3 to form a unified structure with the balloon 2. This free state is a weak connection method, where the atomized adhesive is cured to form a weak but tight connection. The advantage of this is that in tortuous lesion sites, the serrated component 1 may undergo large local deformation. The weak connection allows the braided layer 4 to dynamically adjust itself during large deformations, preventing the serrated component 1 from cutting the braided fibers under a fixed connection. This is a special technique for protecting the braided layer 4.

[0068] In one embodiment of this invention, the braided yarn of the braided layer 4 is made of elastic yarn. Commonly used materials for elastic yarn include: nylon (Polyamide / Nylon), polypropylene (Polypropylene), polyester (Polyester), polytetrafluoroethylene (ePTFE), and ultra-high molecular weight polyethylene. The elastic modulus of the elastic yarn can be adjusted as needed by adjusting the twist number, yarn diameter, etc.

[0069] In one embodiment of this invention, the serrated balloon has the following advantages: ① With the combined action of the braided layer 4, the three-layer adhesive layer 3, and the adhesive-reinforced end 13, the serrated balloon can maintain a high pressure state (15 atm~25 atm) to work, thereby making it more effective at destroying plaques and achieving better clinical results; ② Overall, it is safer because the elongation rates of the serrated part 1 and the balloon 2 are smaller, thus preventing the serrated part 1 from falling off; ③ A special woven layer 4 is fitted on the outside of the serrated part 1 and the balloon 2, so that even if the serrated part 1 breaks accidentally, it can be safely removed from the body, forming an additional double layer of safety protection. ④ The special end structure of the saw tooth 1 (bonded reinforced end 13) can effectively avoid the main failure mode of the saw tooth 1 - end lifting, which can cause the entire saw tooth 1 to fall off (especially in the case of repeated entry and exit from the sheath).

[0070] Example 4 This embodiment provides a method for manufacturing a serrated part, which is used to prepare the serrated part 1 in Embodiment 1, including the following steps: plastically processing the end side region (at least one end) of the strip 11 of the serrated part 1 to form an adhesive-reinforced end 13 with an embedding groove 14, the embedding groove 14 being used to embed into the adhesive layer 3 on the outer surface of the balloon 2.

[0071] In one embodiment of this invention, the plastic processing includes bending or twisting. Bending is used to bend the adhesive reinforcing end 13 into a wavy structure, with the crests and troughs of the adhesive reinforcing end 13 forming an embedding groove 14. Twisting is used to twist the end of the strip 11 to form the adhesive reinforcing end 13, with any two adjacent serrations 12 on the adhesive reinforcing end 13 forming an embedding groove 14, and the twist angle being less than or equal to 90° (or, alternatively, less than or equal to 135°; or, less than or equal to 100°).

[0072] In one embodiment of this example, the bending process may be performed using stamping or other processes.

[0073] Example 5 like Figures 14 to 18 This embodiment provides a peripheral serrated balloon dilation catheter 100. The peripheral serrated balloon dilation catheter 100 has an integral exchangeable structure, consisting of a distal end 101, a radiopaque ring 102, and a braided balloon 103 (e.g., Figure 15 As shown, the catheter consists of components including a balloon 2 (with a braided layer 4), serrated elements 1, an inner tube 104, a double-lumen tube 105, a reinforcing tube 106, and a catheter seat 107. The distal end of the catheter has a braided balloon 103 with three serrated elements 1 evenly distributed on its surface. The double-lumen tube 105 has two independent lumens: one for inflating the braided balloon 103 and the other for guidewire insertion. The braided balloon 103 has two radiopaque imaging rings 102 for positioning and indicating the effective dilation portion. Information such as the diameter and length of the braided balloon 103, and compatible guidewires are printed on the seat. The peripheral serrated balloon dilation catheter 100 is intended for dilating lesions in the iliac artery, femoral artery, iliofemoral artery, popliteal artery, subpopliteal artery, and renal artery, and for treating obstructive lesions in autologous or artificial arteriovenous dialysis fistulas. It is understandable that the serrated part 1 of the peripheral serrated balloon dilation catheter 100 has an adhesive-reinforced end 13 feature; that is, the serrations 12 (such as those on the end side region of the strip 11 on the serrated part 1) in the serrated part 1. Figure 17 (as shown) and the serrations 12 of the middle region 112 of the strip 11 (as shown) Figure 16 (As shown) have different serration orientations; or, the end-side region of the strip 11 of the serrated element 1 is plastically processed to form an adhesive-reinforced end 13 with an embedded groove 14. The peripheral serrated balloon dilation catheter 100 typically has an effective balloon length L1, an effective catheter length L2, a serrated element length L3, an inflated balloon diameter D, and a double-lumen outer diameter d1.

[0074] Complete the preparation of the peripheral serrated balloon dilation catheter 100 according to the following steps: 1. Remove the balloon protective cannula.

[0075] 2. Flush the guidewire lumen with sterile heparinized saline (the solution flows out from the distal end of the braided balloon 103).

[0076] 3. Fill the syringe or filling device with approximately 4 ml (cc) of the contrast agent and saline mixture.

[0077] 4. Connect the inflation chamber of the braided balloon 103 to a syringe or inflation device, adjust the distal end of the balloon catheter and make the braided balloon 103 point vertically downward.

[0078] 5. Pull back the syringe or use the inflation device to create negative pressure, shrinking the braided balloon 103. Slowly release the pressure to zero, allowing the contrast agent to fill the inflation lumen of the balloon catheter.

[0079] 6. Remove the syringe or inflation device from the inflation port of the balloon catheter.

[0080] 7. Purge the air from the syringe or inflation device. Reconnect the syringe or inflation device to the inflation port of the balloon catheter. Maintain negative pressure within the braided balloon 103.

[0081] 8. Slowly release the pressure in the device to zero.

[0082] 9. Remove the syringe (if using) and connect the inflation device to the inflation port of the balloon catheter, ensuring no air enters.

[0083] The following are the instructions for use of the peripheral serrated balloon dilation catheter 100: Insertion of balloon catheter: 1. Push the guidewire along the catheter sheath into and through the target lesion site, insert the tip of the balloon catheter into the end of the guidewire and push the balloon catheter, confirming that the guidewire exits from the guidewire orifice of the proximal catheter seat 107.

[0084] 2. Push the balloon catheter along the guidewire to the narrowed area. Under fluoroscopic guidance, use a radiopaque marker ring to position the braided balloon 103 at the narrowed area. To facilitate insertion, the braided balloon 103 must be evacuated to a completely negative pressure.

[0085] Balloon inflation: 1. The stenotic site was expanded by inflating the woven balloon 103 using standard percutaneous endovascular angioplasty.

[0086] Note: Do not exceed the rated burst pressure. Inflating the braided balloon 103 to a pressure higher than the rated burst pressure will damage the balloon catheter or over-dilate the blood vessel.

[0087] 2. After filling, the expansion effect needs to be observed under a microscope.

[0088] 103-inch woven balloon retraction: 1. The retraction filling device generates negative pressure, causing the woven balloon 103 to retract.

[0089] 2. Keeping the guidewire in the same position and maintaining the vacuum state in the braided balloon 103, retract the catheter.

[0090] Note: If the braided balloon 103 cannot be retrieved through the sheath, retrieve the catheter and sheath as a whole.

[0091] 3. If the woven balloon 103 is inflated and deflated multiple times, the device may encounter some resistance when retracting.

[0092] Specific examples have been used to illustrate the principles and implementation methods of this invention. The descriptions of the above embodiments are only for the purpose of helping to understand the method and core ideas of this invention. Furthermore, those skilled in the art will recognize that, based on the ideas of this invention, there will be changes in the specific implementation methods and application scope. Therefore, the content of this specification should not be construed as a limitation of this invention.

Claims

1. A sawing element comprising a strip (11) capable of being bonded to the outer surface of a balloon (2) by means of an adhesive layer (3), said strip (11) being provided with saw teeth (12) arranged at a distance along the length of the strip, characterized in that, The strip (11) has an adhesive-reinforced end (13) on its end side, and the adhesive-reinforced end (13) is provided with an embedding groove (14) for embedding the adhesive layer (3).

2. The sawtooth member of claim 1, wherein, The adhesive-reinforced end (13) is formed by plastic processing of the end region of the strip (11).

3. The sawtooth member of claim 1, wherein, The number of serrations (12) on the adhesive-reinforced end (13) is 1 to 6.

4. The sawtooth member of claim 2, wherein, The adhesive reinforcement end (13) is a wavy line structure formed by bending. The crests and troughs on the adhesive reinforcement end (13) constitute the embedded groove (14). The bending direction is perpendicular to the length direction of the strip (11) and the side of the serration (12).

5. The sawtooth member of claim 4, wherein, The bending radius of the adhesive-reinforced end (13) is r=l / π, where l is the distance between two adjacent saw teeth (12).

6. The sawtooth member of claim 2, wherein, The adhesive reinforcement end (13) is formed by twisting the end of the strip (11) with a twist angle less than or equal to 135°. The gap between any two adjacent serrations (12) on the adhesive reinforcement end (13) constitutes the embedding groove (14).

7. The sawtooth component according to claim 1, wherein the sawtooth (12) on the adhesive reinforcing end (13) and the sawtooth (12) in the middle region of the strip (11) have different sawtooth orientations, and the gap between any two adjacent sawtooth (12) on the adhesive reinforcing end (13) constitutes the embedding groove (14).

8. The sawtooth member of claim 7, wherein, In the projection along the length of the strip (11), the serrations (12) on the adhesive reinforcement end (13) form an angle with the serrations in the middle region of the strip (11), and the angle is less than or equal to 135°.

9. A sawtooth balloon characterized by, The device includes a balloon (2) and serrated members as described in any one of claims 1 to 8, arranged at circumferential intervals along the outer surface of the balloon (2). The length direction of the strips (11) of the serrated members is arranged along the axial direction of the balloon (2). The strips (11) are connected to the balloon (2) by a connecting structure, the connecting structure including at least the adhesive layer (3).

10. The sawtooth balloon of claim 9, wherein, The adhesive layer (3) includes a bottom layer adhesive (31), a middle layer adhesive (32) and a top layer adhesive (33). The bottom layer adhesive (31) is disposed on the outer surface of the balloon (2). The middle layer adhesive (32) is disposed on the outer surface of the bottom layer adhesive (31). The strip (11) is embedded in the middle layer adhesive (32). The top layer adhesive (33) covers the strip (11) on the middle layer adhesive (32).

11. The sawtooth balloon of claim 10, wherein, The bottom layer adhesive (31), the middle layer adhesive (32), and the top layer adhesive (33) are all UV adhesives.

12. The sawtooth balloon of claim 10, wherein, The thickness of the bottom layer adhesive (31) is 0.02mm~0.06mm, the thickness of the middle layer adhesive (32) is 0.1mm~0.15mm, and the thickness of the top layer adhesive (33) is 0.02mm~0.06mm.

13. The sawtooth balloon of claim 11, wherein, The middle layer adhesive (32) is located in the middle of the bottom layer adhesive (31) in the width direction. The width of the bottom layer adhesive (31) is w1=w0+0.6mm~1mm, and the width of the middle layer adhesive (32) is w2=w0+0.2mm~0.6mm, where w0 is the width of the strip (11).

14. The sawing balloon of claim 9, wherein, The connection structure also includes a braided layer (4) that binds the strip (11) to the balloon (2).

15. The sawtooth balloon of claim 14, wherein, The woven layer (4) includes a densely woven area (41) and a loosely woven area (42). The loosely woven area (42) is located in the area corresponding to the serrations (12) on the strip (11), and the densely woven area (41) is located in the area corresponding to the gap between two adjacent serrations (12) on the strip (11).

16. The sawtooth balloon of claim 14 or 15, wherein, The braided layer (4) is located outside the adhesive layer (3).

17. The sawing balloon of claim 14, wherein, The braided layer (4) uses elastic yarn for its braiding.

18. A method of making a saw blade, comprising: Includes the following steps: The end region of the strip (11) with serrations (12) is plastically processed to form an adhesive-reinforced end (13) with an embedding groove (14) for embedding into the adhesive layer (3) on the outer surface of the balloon (2).

19. The method for manufacturing a saw toothed part according to claim 18, characterized in that, The plastic processing includes bending or twisting; the bending process is used to bend the adhesive reinforcing end (13) into a wavy line structure, and the crests and troughs on the adhesive reinforcing end (13) constitute the embedding groove (14); the twisting process is used to twist the end of the strip (11) to form the adhesive reinforcing end (13), and any two adjacent serrations (12) on the adhesive reinforcing end (13) constitute the embedding groove (14), and the twisting angle is less than or equal to 135°.

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