Balloon dilatation catheter for vascular ostium sites and methods of use thereof

Abstract

The application relates to a balloon dilatation catheter for a blood vessel opening site and a use method thereof, and belongs to the technical field of medical devices. The balloon dilatation catheter comprises an inner tube, an outer tube sleeved on the outer circumferential surface of the inner tube and a balloon, the balloon comprises a fixed part, a dilatation part and a tail end part; the dilatation part is located between the fixed part and the tail end part, the fixed part and the dilatation part are both cylindrical, and a braided mesh is sleeved on the outer circumferential surface of the fixed part; and the tail end part is trumpet-shaped, and the opening is directed to the dilatation part. The tail end part is clamped at the blood vessel opening site, the dilatation part is fixed by the fixed part and the tail end part at the same time, the movement of the dilatation part is prevented, the stability is improved, the braided mesh is sleeved on the outer circumferential surface of the fixed part, a pillow part is formed after inflation, excessive inflation is prevented, the inner wall of the blood vessel is prevented from being damaged, and the safety is improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a balloon dilation catheter for use at vascular opening sites and its method of use. Background Technology

[0002] Atherosclerosis is a major cause of coronary heart disease, cerebral infarction, and peripheral vascular disease. Atherosclerotic stenosis can occur anywhere in the blood vessels of the body, but it is more common at the opening of blood vessels.

[0003] To alleviate these problems, there are currently two methods: one is to use a balloon dilation catheter, and the other is to use a stent. A balloon dilation catheter is used to dilate the narrowed area to restore the blood vessel size; however, if aortic dissection or recoil occurs, a stent needs to be implanted using a balloon dilation catheter to support the blood vessel.

[0004] Balloon dilation catheters mainly consist of a balloon section. Whether used alone or in conjunction with a stent, the balloon expands to support narrowed areas or the stent. However, during balloon inflation, the stent expands, forming a unique funnel-shaped structure that conforms to the anatomy of the vertebral artery opening, allowing the stent to adhere tightly to the vessel wall. As the funnel-shaped balloon inflates, a reaction force is generated to move the balloon proximally in order to conform the stent to the vertebral opening. This can cause the balloon section to shift in position. Furthermore, since there are no constraints on the outer surface of the balloon section during inflation, there is a risk that the balloon may over-dilate the vessel, potentially causing it to rupture. Summary of the Invention

[0005] Based on the above analysis, the present invention aims to provide a balloon dilation catheter for use at the opening of blood vessels and a method of using the same, which can ensure greater stability and safety of the balloon dilation catheter during use.

[0006] On one hand, the present invention provides a balloon dilation catheter for a vascular opening, comprising an inner tube, an outer tube sleeved on the outer circumferential surface of the inner tube, and a balloon, wherein the balloon comprises a fixing part, an dilation part, and a tail end;

[0007] The expansion portion is located between the fixing portion and the tail end portion. Both the fixing portion and the expansion portion are cylindrical, and a woven mesh is fitted on the outer peripheral surface of the fixing portion. The tail end portion is trumpet-shaped with its opening facing the expansion portion.

[0008] Furthermore, the woven mesh is composed of uniformly distributed annular fiber bands, and the annular fiber bands are connected to each other by multiple fixing bands; when the balloon inflates, a occipital protrusion is formed, and the direction of the occipital protrusion is away from and perpendicular to the central axis of the fixing part.

[0009] Furthermore,

[0010] Furthermore, the annular fiber band is a truncated ring with a smaller top and a larger bottom. The smaller cross section of the truncated ring faces the expansion portion. When the balloon expands, it forms a occipital protrusion. The direction of the occipital protrusion is away from the central axis of the fixing portion and forms an acute angle with the fixing portion.

[0011] Furthermore, the angle between the direction of the occipital protrusion and the fixing part is 30-60°.

[0012] Furthermore, a woven mesh is fitted onto the outer peripheral surface of the expansion portion, and the woven mesh covers more than half of the area of ​​the outer peripheral surface of the expansion portion.

[0013] Furthermore, a woven mesh is fitted onto the outer peripheral surface of the balloon. The woven mesh is composed of fiber filaments, which are parallel to the central axis of the balloon.

[0014] Furthermore, the thickness of the expansion portion is greater than the thickness of the tail end portion, and the thickness of the tail end portion is greater than the thickness of the fixing portion.

[0015] Furthermore, multiple developing marks are provided on the inner tube.

[0016] On the other hand, the present invention provides a method of using a balloon dilation catheter for a vascular opening, comprising the following steps:

[0017] S1: Guided by the inner tube, the tail end of the balloon is placed at the opening of the blood vessel. As the pressure inside the balloon increases, the fixing part is inflated and fixed, and the woven mesh is used for limiting the position.

[0018] S2: Continue to increase the pressure, and fix the tail end at the opening after it expands;

[0019] S3: Continue to increase the pressure to expand the expansion section, thereby expanding the narrow section;

[0020] S4: Reduce the pressure so that the tail end, the fixed part and the dilation part retract simultaneously, and the balloon dilation catheter is removed.

[0021] Compared with the prior art, the present invention can achieve at least one of the following beneficial effects:

[0022] 1. In this invention, the balloon is divided into three parts: a fixing part, an expansion part, and a tail end. The tail end is snapped into the opening of the blood vessel. The expansion part is fixed by the fixing part and the tail end at the same time to prevent the expansion part from moving and improve stability. A woven mesh is provided on the outer peripheral surface of the fixing part. After expansion, it forms a occipital protrusion to prevent over-expansion and damage to the inner wall of the blood vessel, thereby improving safety.

[0023] 2. This invention provides a method for using a balloon dilation catheter. First, the tail end is placed at the opening of the blood vessel. The fixing part is expanded first for positioning and fixation. Then, the tail end is expanded and fixed at the opening. Finally, the dilation part is expanded to dilate the narrow part of the blood vessel. By fixing the dilation part with both the fixing part and the tail end, movement of the dilation part is prevented, thus improving stability.

[0024] In this invention, the above-described technical solutions can be combined with each other to achieve more preferred combinations. Other features and advantages of this invention will be set forth in the following description, and some advantages may become apparent from the description or be learned by practicing the invention. The objects and other advantages of this invention can be realized and obtained from what is particularly pointed out in the description and drawings. Attached Figure Description

[0025] The accompanying drawings are for illustrative purposes only and are not intended to limit the invention. Throughout the drawings, the same reference numerals denote the same parts.

[0026] Figure 1 This is a schematic diagram showing the position of the balloon dilation catheter at the opening of the blood vessel.

[0027] Figure 2 This is a diagram showing the overall structure of a balloon dilation catheter;

[0028] Figure 3 This is a schematic diagram of the woven mesh structure at the fixing part in Example 1;

[0029] Figure 4 This is a schematic diagram of the woven mesh structure at the fixing part in Example 2;

[0030] Figure 5 This is a schematic diagram of the woven mesh structure at the fixing part in Example 3;

[0031] Figure 6 This is a schematic diagram of the woven mesh structure at the expansion section in Example 4;

[0032] Figure 7 This is a schematic diagram of the balloon woven mesh structure in Example 5;

[0033] Figure label:

[0034] 1. Inner tube; 2. Outer tube; 3. Balloon; 31. Fixation part; 32. Dilation part; 33. Tail end; 34. Separating ring; 4. Blood vessel; 5. Braided mesh; 51. Fiber band; 52. Fixation band; 6. Imaging marker. Detailed Implementation

[0035] The preferred embodiments of the present invention will now be described in detail with reference to the accompanying drawings, which constitute a part of the present invention and are used together with the embodiments of the present invention to illustrate the principles of the present invention, but are not intended to limit the scope of the present invention.

[0036] Atherosclerosis is a major cause of coronary heart disease, cerebral infarction, and peripheral vascular disease. Atherosclerotic stenosis can occur anywhere in the blood vessels of the body, but it is more common at the opening of blood vessels.

[0037] To dilate sclerosing stenosis and alleviate the aforementioned problems, there are currently two main methods: one is to directly dilate the sclerosing stenosis using a balloon dilatation catheter, and the other is to use a stent to dilate the stenosis with the support of the stent. Using a balloon dilatation catheter dilates the narrowed area to restore the vessel size; however, if aortic dissection or recoil occurs, a stent needs to be implanted using a balloon dilatation catheter to support the vessel.

[0038] Balloon dilation catheters mainly consist of a balloon section. Whether used alone or in conjunction with a stent, the balloon expands to support the narrowed area or the stent. However, during balloon inflation, the stent expands, forming a unique funnel-shaped structure that conforms to the anatomy of the vertebral artery opening, allowing the stent to adhere tightly to the vessel wall. As the funnel-shaped balloon inflates, a reaction force is generated to move the balloon proximally in order to conform the stent to the vertebral opening. This can cause the balloon section to shift in position. Furthermore, since there are no constraints on the outer surface of the balloon section during inflation, there is a risk that the balloon may rupture the vessel.

[0039] The present invention provides a balloon dilation catheter 3 for the opening of a blood vessel 4, comprising an inner tube 1, an outer tube 2 sleeved on the outer peripheral surface of the inner tube 1, and a balloon 3, wherein the balloon 3 includes a fixing part 31, an dilation part 32, and a tail end 33;

[0040] The expansion portion 32 is located between the fixing portion 31 and the tail end portion 33. Both the fixing portion 31 and the expansion portion 32 are cylindrical, and a woven mesh 5 is sleeved on the outer peripheral surface of the fixing portion 31.

[0041] Compared with the prior art, in this invention, the balloon 3 is divided into three parts, including a fixing part 31, an expansion part 32 and a tail end 33. The tail end 33 is engaged with the opening of the blood vessel 4. The expansion part 32 is fixed by the fixing part 31 and the tail end 33 to prevent the expansion part 32 from moving and improve stability. A woven mesh 5 is provided on the outer peripheral surface of the fixing part 31. After expansion, it forms a occipital protrusion, which reduces the contact area between the fixing part 31 and the inside of the blood vessel 4, prevents excessive expansion, damages the inner wall of the blood vessel 4, and improves safety.

[0042] Specifically, the tail end 33 of the balloon 3 is sealed to the outer tube 2, and the fixing part 31 of the balloon 3 is sealed to the inner tube 1, forming a closed space.

[0043] It should be noted that one end of the balloon 3 in the balloon dilation catheter is sealed to the outer tube 2, and the other end of the balloon 3 is sealed to the inner tube 1. That is, the tail end 33 of the balloon 3 is sealed to the outer tube 2, and the fixing part 31 of the balloon 3 is sealed to the inner tube 1. Therefore, the balloon 3 is a closed space. The balloon 3 expands and contracts by increasing or decreasing the pressure.

[0044] In this invention, the inner tube 1 primarily serves a guiding function, enabling the outer tube 2 and balloon 3 to move within the blood vessel 4. Both the balloon 3 and the outer tube 2 are fitted onto the inner tube 1, and the balloon 3 is connected to the outer tube 2. Increasing pressure through the outer tube 2 causes the balloon 3 to inflate, thus dilating the sclerotic stenosis. Furthermore, the expansion of the balloon 3 facilitates the extension of the stent, which in turn supports the sclerotic stenosis. The tail end 33 is trumpet-shaped, allowing for better dilation of the opening.

[0045] Specifically, the fixing part 31, the expansion part 32 and the tail end part 33 are separated by a partition ring 34.

[0046] It should be noted that in this invention, the balloon 3 is divided into three parts by the partition ring 34, namely the fixing part 31, the expansion part 32, and the tail end part 33. When the balloon 3 inflates, the partition ring 34 does not change its own state, and it presents a shape with a high center on both sides. Moreover, the partition ring 34 has a certain limiting effect on the fixing part 31, the expansion part 32, and the tail end part 33.

[0047] Furthermore, after the separation ring 34 separates the parts, the length of the fixing part 31 is less than the length of the tail end 33, and the length of the tail end 33 is less than the length of the expansion part 32. The length of the expansion part 32 is much greater than the lengths of the fixing part 31 and the tail end 33. When the expansion part 32 expands, it can better expand the hardened narrow portion and completely cover the hardened narrow area.

[0048] In one possible design, the woven mesh 5 is composed of uniformly distributed annular fiber bands 51, and the annular fiber bands 51 are connected to each other by a plurality of fixing bands 52; when the balloon 3 inflates, it forms a occipital protrusion, the direction of which is away from and perpendicular to the central axis of the fixing part 31.

[0049] In one possible design, the woven mesh 5 is woven from uniformly distributed fiber filaments.

[0050] It should be noted that in this invention, the annular fiber strips 51 are evenly distributed along the length of the fixing part 31, and there is a certain distance between the annular fiber strips 51. The annular fiber strips 51 at both ends are fixed to the fixing part 31. Moreover, the annular fiber strips 51 are connected by multiple fixing strips 52 (the number of fixing strips 52 can be 2, 3 or more) to form an integral woven net 5.

[0051] Most importantly, a hollow space is formed between the annular fiber band 51 and the fixing band 52. When the fixing part 31 is stamped and expanded, on the one hand, the woven mesh 5 does not expand with the volume change of the fixing part 31 and limits the fixing part 31 to prevent it from over-expanding and damaging the blood vessel 4; on the other hand, the fixing part 31 continues to expand from the hollow space to form a occipital protrusion until it abuts against the inner wall of the blood vessel 4 and has an interference fit with the inner tube 1 of the blood vessel 4, thereby fixing the tail end 33 and the expansion part 32 to ensure its stability.

[0052] In one possible design, the woven mesh 5 is composed of annular fiber strips 51 and semi-annular fiber strips 51, with the semi-annular fiber strips 51 spaced apart and relatively distributed, and the fiber strips 51 are connected to each other by a fixing strap 52.

[0053] It should be noted that, in this invention, the annular fiber bands 51 and the semi-circular fiber bands are uniformly arranged along the length of the balloon or the fixing part, while the semi-annular fiber bands 51 are spaced apart and relatively distributed. When the balloon expands, an occipital protrusion is formed, and the directions of each two adjacent occipital protrusions are opposite.

[0054] A hollow space is also formed between the annular fiber band 51 and the semi-annular fiber band 51. When the fixing part 31 expands, it continues to expand from the hollow space to form an occipital protrusion until it abuts against the inner wall of the blood vessel 4. The directions of each pair of adjacent occipital protrusions are also opposite.

[0055] In one possible design, the annular fiber band 51 is a truncated ring with a smaller top and a larger bottom. The smaller cross section of the truncated ring faces the expansion portion 32. When the balloon 3 expands, it forms a occipital protrusion. The direction of the occipital protrusion is away from the central axis of the fixing portion 31 and forms an acute angle with the fixing portion 31.

[0056] Preferably, the angle between the direction of the protrusion of the pillow portion and the fixing portion 31 is 30-60°.

[0057] It should be noted that in this invention, the annular fiber strips 51 are evenly distributed along the length of the fixing part 31, and there is a certain distance between the annular fiber strips 51. The annular fiber strips 51 at both ends are fixed to the fixing part 31. Moreover, the annular fiber strips 51 are connected by multiple fixing strips 52 (the number of fixing strips 52 can be 2, 3 or more) to form an integral woven net 5.

[0058] Most importantly, the annular fiber band 51 is shaped like a truncated ring, with the smaller cross-section of the truncated ring facing the expansion portion 32, and a hollow space is formed between the annular fiber band 51 and the fixing band 52. When the fixing portion 31 is stamped and expanded, on the one hand, the woven mesh 5 does not expand with the volume change of the fixing portion 31, and limits the fixing portion 31 to prevent it from over-expanding and damaging the blood vessel 4; on the other hand, the fixing portion 31 continues to expand from the hollow space to form a occipital protrusion. The direction of the occipital protrusion is away from the central axis of the fixing portion 31 and forms an acute angle with the fixing portion 31 (the angle is adjustable, preferably 30-60°, for example 31°, 35°, 38°, 40°, 43°, 47°, 55° or 60°) until it abuts against the inner wall of the blood vessel 4 and forms an interference fit with the inner tube 1 of the blood vessel 4, thereby fixing the tail end 33 and the expansion portion 32 and ensuring its stability.

[0059] In this invention, the annular fiber band 51 and the fixing band 52 are woven from fiber filaments. The size of the annular fiber band 51 and the fixing band 52 can be modified according to actual needs. That is, the width of the annular fiber band 51 and the fixing band 52 can be changed by adjusting the weaving density or number of fiber filaments.

[0060] Specifically, a woven mesh 5 is fitted onto the outer peripheral surface of the expansion portion 32, and the woven mesh 5 covers more than half of the area of ​​the outer peripheral surface of the expansion portion 32.

[0061] It should be noted that in this invention, when the sclerotic stenosis area is distributed circumferentially and its area is greater than half, the expansion portion 32 can be used alone without the need for the braided mesh 5. When the sclerotic stenosis area is less than half, the braided mesh 5 needs to be fitted onto the outer peripheral surface of the expansion portion 32 to prevent the expansion portion 32 from expanding excessively, thus protecting the blood vessels 4 that have not undergone sclerotic stenosis and improving safety.

[0062] The woven mesh 5 is a semi-cylindrical structure, formed by cutting a complete cylinder in half along its axis. It has a semi-circular cross-section and a planar open end. Viewed from the side, it is half a rectangle; viewed from the open end, it is a semi-circle. Both ends of the woven mesh 5 are fixed to the separating rings 34. When the expansion section 32 expands, a portion of the expansion section 32 abuts against the inner wall of the woven mesh 5, restricting its further expansion; as the expansion section 32 continues to expand, it continues to expand from the opening of the woven mesh 5, expanding the hardened, narrow area. The woven mesh 5 fitted onto the expansion section 32 can be made of woven fiber filaments.

[0063] In one possible design, the woven mesh fitted on the fixing part 31 and the expansion part 32 has the same structure.

[0064] Furthermore, the braided mesh 5 can rotate around the central axis of the expansion section 32, which can change the restrictive direction of the braided mesh 5 and does not hinder the expansion section 32 from expanding the hardened narrow area.

[0065] Specifically, a woven mesh 5 is fitted on the outer peripheral surface of the balloon 3. The woven mesh 5 is composed of fiber filaments, which are parallel to the central axis of the balloon 3.

[0066] It should be noted that, in this invention, multiple fiber filaments are distributed along the length of the entire outer circumferential surface of the balloon 3. The fiber filaments are parallel to each other and parallel to the central axis of the balloon 3. The fiber filaments are connected by circumferentially distributed fiber filaments, which can be evenly distributed or irregularly distributed, forming a woven mesh 5 with a hollow structure on the outer circumferential surface of the balloon 3.

[0067] Preferably, at the expansion portion 32 of the balloon 3, a woven mesh 5 formed of fiber filaments covers more than half of the outer peripheral surface area of ​​the expansion portion 32.

[0068] Preferably, the shape of the woven mesh 5 is the same as that of the balloon 3, and the size of the woven mesh 5 is larger than that of the balloon 3.

[0069] During the inflation of balloon 3, balloon 3 bulges out from the hollow structure formed between the fibrous filaments, forming a semi-circular protrusion. The grooves between the protrusions facilitate the continued flow of blood and improve safety when balloon 3 expands.

[0070] Specifically, the thickness of the expansion portion 32 is greater than the thickness of the tail end portion 33, and the thickness of the tail end portion 33 is greater than the thickness of the fixing portion 31.

[0071] It should be noted that in this invention, the thicknesses of the fixing part 31, the dilating part 32, and the tail end 33 in the balloon 3 are different, and in order from thinnest to thickest, they are the fixing part 31, the tail end 33, and the dilating part 32. After pressure is introduced, the balloon 3 inflates as a whole. The fixing part 31 inflates first, forming a occipital protrusion that firmly fixes the dilating part 32 and the tail end 33, preventing the tail end 33 from generating a reaction force that moves proximally during inflatation, thus improving stability. With continued pressure increase, the tail end 33 inflates next, fixed at the opening. The diameter of the tail end 33 is slightly larger than the diameter of the blood vessel 4. After dilation, the tail end 33 prevents the balloon 3 dilation catheter from moving towards the fixing part 31. With continued pressure increase, the dilating part 32 inflates last, dilating the sclerotic stenosis area.

[0072] Specifically, the fibers are made of polymeric materials, including polypropylene, PLLA, PEEK, PI, aramid, polyester fiber, aromatic polyester, carbon fiber, and aliphatic polyamide.

[0073] Specifically, the fibers are made of metal, including 304 stainless steel, 316 stainless steel and cobalt-chromium alloy.

[0074] It should be noted that the annular fiber band 51 and the fixing band 52 described in this invention are both woven from fiber filaments, and the fiber filaments can be made of polymer materials or metals, all of which are medical grade, such as polypropylene, 304 stainless steel, etc.

[0075] Specifically, multiple developing marks 6 are provided on the inner tube 1.

[0076] It should be noted that in this invention, the number of imaging markers 6 is at least two, which can identify the starting and ending positions of the dilation portion 32 within the blood vessel 4.

[0077] The present invention also provides a method of using a balloon dilation catheter 3 for the opening of a blood vessel 4, comprising the following steps:

[0078] S1: Guided by the inner tube 1, the tail end 33 of the balloon 3 is placed at the opening of the blood vessel 4. As the internal pressure of the balloon 3 increases, the fixing part 31 expands. Due to the restriction of the woven mesh 5, a occipital protrusion is formed and fixed to the distal end of the blood vessel.

[0079] S2: Continue to increase the pressure, and after the tail end 33 expands, it is fixed at the opening;

[0080] S3: Continue to increase the pressure to expand the expansion section 32, thereby expanding the narrow part;

[0081] S4: Reduce the pressure so that the tail end 33, the fixing part 31 and the dilation part 32 retract simultaneously, and the balloon 3 dilation catheter is removed.

[0082] Compared with the prior art, the balloon 3 in this invention is divided into three parts, which are, in order from thinnest to thickest, a fixing part 31, a tail end 33 and an expansion part 32, which is completely different from the existing balloon 3 expansion catheter with uniform thickness.

[0083] It should be noted that the operation is completely different from existing methods, which inflate the balloon 3 all at once. In this invention, the balloon 3 inflates sequentially. First, guided by the inner tube 1, the tail end 33 of the balloon 3 is placed at the opening of the blood vessel 4. After pressure is applied, the entire balloon 3 inflates. The fixing part 31 inflates first, forming a occipital protrusion that firmly fixes the dilator part 32 and the tail end 33, preventing the tail end 33 from moving proximally during inflatation and improving stability. As pressure continues to increase, the tail end 33 inflates next, fixed at the opening. The diameter of the tail end 33 is slightly larger than the diameter of the blood vessel 4, and its expansion prevents the balloon 3 dilation catheter from moving towards the fixing part 31. Finally, as pressure continues to increase, the dilator part 32 inflates last, dilating the sclerotic stenosis area.

[0084] To more clearly describe the present invention, the following embodiments and comparative examples are provided for further illustration.

[0085] Example 1

[0086] Reference Figure 1-3 This embodiment provides a balloon 3 dilation catheter for the opening of a blood vessel 4, including an inner tube 1, an outer tube 2 sleeved on the outer circumferential surface of the inner tube 1, and a balloon 3. The balloon 3 includes a fixing part 31, an dilation part 32, and a tail end 33. The tail end 33 of the balloon 3 is sealed to the outer tube 2, and the fixing part 31 of the balloon 3 is sealed to the inner tube 1, forming a closed space.

[0087] The expansion portion 32 is located between the fixing portion 31 and the tail end portion 33, and the fixing portion 31, the expansion portion 32 and the tail end portion 33 are separated by a partition ring 34. The thickness of the expansion portion 32 is greater than the thickness of the tail end portion 33, and the thickness of the tail end portion 33 is greater than the thickness of the fixing portion 31.

[0088] Both the fixing part 31 and the expanding part 32 are cylindrical, and a woven mesh 5 is fitted on the outer peripheral surface of the fixing part 31; the tail end 33 is trumpet-shaped.

[0089] The woven mesh 5 is composed of uniformly distributed annular fiber bands 51, and the annular fiber bands 51 are connected to each other by multiple fixing bands 52; when the balloon 3 inflates, it forms a occipital protrusion, the direction of which is away from and perpendicular to the central axis of the fixing part 31; both the annular fiber bands 51 and the fixing bands 52 are woven from fiber filaments, and the fiber filaments can be medical polymer materials, such as polypropylene.

[0090] The number of developing marker 6 is two;

[0091] This embodiment also provides a method for using the balloon 3 dilation catheter, including the following steps:

[0092] S1: Guided by the inner tube 1, the tail end 33 of the balloon 3 is placed at the opening of the blood vessel 4. As the internal pressure of the balloon 3 increases, the fixing part 31 is expanded and fixed, and the woven mesh 5 is used for limiting the position.

[0093] S2: Continue to increase the pressure, and after the tail end 33 expands, it is fixed at the opening;

[0094] S3: Continue to increase the pressure to expand the expansion section 32, thereby expanding the narrow part;

[0095] S4: Reduce the pressure so that the tail end 33, the fixing part 31 and the dilation part 32 retract simultaneously, and the balloon 3 dilation catheter is removed.

[0096] During dilation or use, the balloon 3 of this invention expands in different sequences. First, guided by the inner tube 1, the tail end 33 of the balloon 3 is placed at the opening of the blood vessel 4. After pressure is applied, the entire balloon 3 expands. The fixing part 31 expands first, forming a occipital protrusion that firmly fixes the dilating part 32 and the tail end 33, preventing the tail end 33 from generating a reaction force that moves proximally during expansion and improving stability. As pressure continues to increase, the tail end 33 expands next and is fixed at the opening. The diameter of the tail end 33 is slightly larger than the diameter of the blood vessel 4. After expansion, the tail end 33 prevents the balloon 3 dilation catheter from moving towards the fixing part 31. As pressure continues to increase, the dilating part 32 expands last, dilating the sclerotic stenosis area.

[0097] Example 2

[0098] Reference Figure 4 The preparation process of Example 2 is largely the same as that of Example 1. The difference is that the woven net 5 in Example 2 is composed of annular fiber strips 51 and semi-annular fiber strips 51. The semi-annular fiber strips 51 are distributed at intervals and are connected to each other by a fixing strip 52.

[0099] A hollow space is also formed between the annular fiber band 51 and the semi-annular fiber band 51. When the fixing part 31 expands, it continues to expand from the hollow space to form an occipital protrusion until it abuts against the inner wall of the blood vessel 4. The directions of each pair of adjacent occipital protrusions are also opposite.

[0100] Example 3

[0101] Reference Figure 5 The preparation process of Example 3 is largely the same as that of Example 1. The difference is that the annular fiber band 51 in Example 3 is a truncated ring with a smaller top and a larger bottom. The smaller cross section of the truncated ring faces the expansion part 32. When the balloon 3 expands, it forms a occipital protrusion. The direction of the occipital protrusion is away from the central axis of the fixing part 31 and forms an acute angle with the fixing part 31.

[0102] The annular fiber band 51 is shaped like a truncated ring, with the smaller cross-section of the truncated ring facing the expansion portion 32, and a hollow space is formed between the annular fiber band 51 and the fixing band 52. When the fixing portion 31 is stamped and expanded, on the one hand, the woven mesh 5 does not expand with the volume change of the fixing portion 31, and limits the fixing portion 31 to prevent it from expanding too quickly and damaging the blood vessel 4; on the other hand, the fixing portion 31 continues to expand from the hollow space to form a occipital protrusion. The direction of the occipital protrusion is away from the central axis of the fixing portion 31 and forms an acute angle with the fixing portion 31 until it abuts against the inner wall of the blood vessel 4 and forms an interference fit with the inner tube 1 of the blood vessel 4, thereby fixing the tail end 33 and the expansion portion 32 to ensure its stability.

[0103] Example 4

[0104] Reference Figure 6 The preparation process of Example 4 is largely the same as that of Example 1. The difference is that in Example 4, a woven mesh 5 is provided on the outer peripheral surface of the expansion part 32, and the woven mesh 5 covers more than half of the area of ​​the outer peripheral surface of the expansion part 32.

[0105] In this embodiment, when the sclerotic stenosis area is less than half, a woven mesh 5 needs to be fitted on the outer peripheral surface of the dilation part 32 to prevent the dilation part 32 from expanding excessively, thereby protecting the blood vessel 4 that has not undergone sclerotic stenosis and improving safety.

[0106] The woven mesh 5 is a semi-cylindrical structure, formed by cutting a complete cylinder in half along its axial direction. It has a semi-circular cross-section and a planar open end. Viewed from the side, it is half a rectangle; viewed from the open end, it is a semi-circle. Both ends of the woven mesh 5 are fixed to the separating rings 34. When the expansion portion 32 expands, a part of the expansion portion 32 abuts against the inner wall of the woven mesh 5, restricting its further expansion; as the expansion portion 32 continues to expand, it continues to expand from the opening of the woven mesh 5, expanding the hardened narrow area.

[0107] Example 5

[0108] Reference Figure 7 The preparation process of Example 5 is largely the same as that of Example 1. The difference is that in Example 5, a woven mesh 5 is provided on the outer peripheral surface of the balloon 3. The woven mesh 5 is composed of fiber filaments, which are parallel to the central axis of the balloon 3.

[0109] Multiple fiber filaments are distributed along the length of the entire outer circumference of the balloon 3. The fiber filaments are parallel to each other and parallel to the central axis of the balloon 3. The fiber filaments are connected by circumferentially distributed fiber filaments, which can be evenly distributed or irregularly distributed, forming a woven mesh 5 with a hollow structure on the outer circumference of the balloon 3.

[0110] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any changes or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in the present invention should be included within the scope of protection of the present invention.

Claims

1. A balloon dilation catheter for use at the opening of a blood vessel, comprising an inner tube (1), an outer tube (2) sleeved on the outer peripheral surface of the inner tube (1), and a balloon (3), characterized in that, The balloon (3) includes a fixing part (31), an expansion part (32) and a tail end (33); The expansion portion (32) is located between the fixing portion (31) and the tail end portion (33). Both the fixing portion (31) and the expansion portion (32) are cylindrical, and a woven mesh (5) is fitted on the outer peripheral surface of the fixing portion (31).

2. The balloon dilation catheter for vascular openings according to claim 1, characterized in that, The woven mesh (5) is composed of uniformly distributed annular fiber bands (51), and the annular fiber bands (51) are connected to each other by multiple fixing bands (52); when the balloon (3) inflates, a occipital protrusion is formed, and the direction of the occipital protrusion is away from and perpendicular to the central axis of the fixing part (31).

3. The balloon dilation catheter for vascular openings according to claim 2, characterized in that, The woven mesh (5) is composed of annular fiber strips (51) and semi-annular fiber strips (51), with the semi-annular fiber strips (51) being distributed at intervals and the fiber strips (51) being connected to each other by a fixing strip (52).

4. The balloon dilation catheter for vascular openings according to claim 2, characterized in that, The annular fiber band (51) is a truncated ring with a smaller top and a larger bottom. The smaller cross section of the truncated ring faces the expansion part (32). When the balloon (3) expands, it forms a occipital protrusion. The direction of the occipital protrusion is away from the central axis of the fixing part (31) and forms an acute angle with the fixing part (31).

5. The balloon dilation catheter for a vascular opening as described in claim 4, characterized in that, The angle between the direction of the occipital protrusion and the fixing part (31) is 30-60°.

6. The balloon dilation catheter for a vascular opening as described in claim 1, characterized in that, A woven mesh (5) is fitted on the outer peripheral surface of the expansion portion (32), and the woven mesh (5) covers more than half of the area of ​​the outer peripheral surface of the expansion portion (32).

7. The balloon dilation catheter for a vascular opening as described in claim 1, characterized in that, A woven mesh (5) is fitted on the outer peripheral surface of the balloon (3). The woven mesh (5) is composed of fiber filaments, which are parallel to the central axis of the balloon (3).

8. The balloon dilation catheter for a vascular opening as described in claim 1, characterized in that, The thickness of the expansion portion (32) is greater than the thickness of the tail end portion (33), and the thickness of the tail end portion (33) is greater than the thickness of the fixing portion (31).

9. The balloon dilation catheter for a vascular opening as described in claim 1, characterized in that, Multiple developing marks (6) are provided on the inner tube (1).

10. A method of using a balloon dilation catheter for a vascular orifice as described in any one of claims 1-9, characterized in that, Includes the following steps: S1: Guided by the inner tube (1), the tail end (33) of the balloon (3) is placed at the opening of the blood vessel (4). As the pressure inside the balloon (3) increases, the fixing part (31) expands. Due to the restriction of the woven mesh (5), a occipital protrusion is formed and fixed to the distal end of the blood vessel. S2: Continue to increase the pressure, and fix the tail end (33) at the opening after it expands; S3: Continue to increase the pressure to expand the expansion part (32) so that the narrow part expands; S4: Reduce the pressure so that the tail end (33), the fixing part (31) and the dilation part (32) retract simultaneously, and remove the balloon (3) dilation catheter.

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