A fully developed focusing balloon for blood vessel stenosis dilation

Abstract

The present invention provides a fully developed focusing balloon for vascular stenosis dilation, comprising: a balloon body; an expansion cutting structure longitudinally arranged on the outer surface of the balloon body; the expansion cutting structure includes a hollow cutting wire and a developed support structure arranged inside the cutting wire; the cutting wire is fixed to the outer surface of the balloon body; both ends of the developed support structure are respectively fixed to both ends of the balloon body. Compared with the prior art, the balloon provided by the present invention consists of a hollow cutting wire and a developed support structure arranged inside the cutting wire to form an expansion cutting structure, so that the overall cutting part of the expansion balloon can be developed under X-ray, making the positioning of the cutting component more accurate. At the same time, it can also provide effective support for the cutting wire, thus not only taking into account the flexibility and passability of the balloon, but also further improving the expansion cutting effect.

Description

Technical Field

[0001] The present invention belongs to the technical field of balloon, and particularly relates to a fully radiopaque and force-concentrating balloon for treating vascular stenosis. Background Art

[0002] Interventional medicine is to insert a special catheter or instrument into the lesion site for angiography, diagnosis and treatment through a percutaneous puncture approach or through the original body orifice under the guidance of imaging medicine (X-ray, ultrasound, CT). Due to its advantages of small trauma, few complications and wide application range (it can be applied to cardiovascular, peripheral vascular tumors or non-vascular fields, etc.), it has become the third major clinical treatment method.

[0003] For a common balloon for treating vascular stenosis, during dilation, due to the compression, rupture of plaques and elastic dilation of blood vessels, elastic recoil is likely to occur, which easily leads to restenosis. Currently, a balloon with metal blades is often used clinically. The distal end of the balloon is usually composed of multiple sharp metal blades longitudinally installed on the balloon surface. Before the balloon reaches the lesion, the blades are tightly wrapped inside the folded balloon. After reaching the lesion, when the balloon is dilated, the blades extend out of the balloon, creating a longitudinal incision in the media of the blood vessel, with less irregular tearing of the intima of the blood vessel and reduced restenosis.

[0004] However, currently on the market, the balloon with metal blades for treating vascular stenosis has poor visibility, and cannot provide good visibility for users during the operation of entering the blood vessel, increasing the complexity of the operation. At the same time, due to the blades attached to the balloon surface, the overall balloon becomes hardened, resulting in poor overall passability of the balloon and difficulty in reaching the lesion through complex tortuous blood vessels, increasing the clinical application risk.

[0005] Chinese Patent with Publication No. CN203379465U discloses a cutting balloon dilation catheter with drugs carried on the balloon surface. The cutting balloon dilation catheter includes a cutting balloon catheter body and a drug coating. Multiple blades are provided on the surface of the balloon, and the shape of the blades is triangular or wedge-shaped. The blades are of solid structure with large rigidity, and the compliance at the head end is poor during clinical use, which is not conducive to passing through the lesion site. This product has no radiopaque marking structure, and cannot provide precise positioning for the dilation and cutting area during the operation, easily causing improper expansion and cutting positions, increasing the operation risk.

[0006] Chinese Patent with Publication No. CN110507385A discloses an inlaid dilation balloon, including a balloon body. An inner cavity is opened inside the balloon body, and multiple annular grooves are opened on the inner surface of the inner cavity. Multiple knife grooves are opened on the outer surface of the balloon body, and the knife grooves are distributed in multiple rings on the surface of the balloon body, and blades are installed in the knife grooves. The blades used for dilation and cutting are arranged in a ring shape, with a complex assembly structure and poor quality stability. Moreover, the annular blades cannot effectively perform transverse dilation and cutting on the lesion area, affecting the operation effect.

[0007] Chinese Patent No. CN111528986A discloses a balloon catheter system, including a catheter, a buffer tube, and a balloon assembly for enhancing the cutting effect. The balloon assembly is composed of a balloon and a metal mesh outside the balloon. The metal mesh wraps around the balloon and is connected to the balloon at the proximal and distal ends respectively. Auxiliary cutting elements are provided on the metal mesh to improve the cutting effect. However, the metal mesh, especially the structure of the auxiliary cutting elements, has a complex auxiliary structure and is difficult to process and mass-produce. Moreover, when the balloon is retracted, the metal mesh is difficult to be compressed, resulting in hardening at both ends of the balloon catheter system, damaging the vascular tissue, and the outer diameter being too large, thus reducing the clinical application range.

[0008] Chinese Patent No. CN205659247U discloses a balloon catheter, including a needle seat, a proximal and distal catheter, a balloon, and a catheter tip connected in sequence. The balloon catheter also includes an inherent guide wire and a guiding guide wire, which are respectively fixed at both ends of the balloon body. However, it results in poor flexibility of the overall balloon and hardening at the head end, which is likely to damage the blood vessels during use. At the same time, only one of the inherent guide wires of this balloon catheter is provided with a radio-opaque marker ring, and it is impossible to provide precise positioning for the dilation and cutting area during the operation, easily causing improper dilation and cutting positions, and increasing the surgical risk.

[0009] Chinese Patent No. CN108577937A discloses a cutting balloon, including a balloon body and cutting wires radially arranged on the outer surface of the balloon body. The two ends of the cutting wires are respectively fixed at both ends of the balloon body. The cutting wires include a folded wave structure and / or a spiral spring structure. However, the mechanical properties of this structure are weak and cannot cope with severely calcified lesion tissues. At the same time, only imaging rings are installed at both ends of this balloon catheter, and it is impossible to provide precise positioning for the dilation and cutting area during the operation, easily causing improper dilation and cutting positions, and increasing the surgical risk.

[0010] Chinese Patent No. CN203379465U discloses a cutting balloon dilation catheter with drugs loaded on the balloon surface. The cutting balloon dilation catheter includes a cutting balloon catheter body and a drug coating. Multiple blades are provided on the surface of the balloon, and the shape of the blades is triangular or wedge-shaped. However, the blades are of a solid structure with high rigidity, and the flexibility of the head end is poor during clinical use, which is not conducive to passing through the lesion site. Moreover, this product has no radio-opaque marking structure, and it is impossible to provide precise positioning for the dilation and cutting area during the operation, easily causing improper dilation and cutting positions, and increasing the surgical risk. Summary of the Invention

[0011] In view of this, the technical problem to be solved by the present invention is to provide a fully imaging and cohesive vascular stenosis dilation balloon that not only has a good imaging effect on the dilation and cutting area, but also can provide excellent dilation and cutting effects, and at the same time can take into account flexibility, facilitating the instrument to smoothly pass through complex and tortuous blood vessels to reach the lesion site.

[0012] The present invention provides a fully developed focusing vascular stenosis dilation balloon, comprising:

[0013] a balloon body;

[0014] a dilation and cutting structure longitudinally arranged on the outer surface of the balloon body;

[0015] the dilation and cutting structure includes a hollow cutting wire and a developed support structure arranged inside the cutting wire;

[0016] the cutting wire is fixed to the outer surface of the balloon body;

[0017] both ends of the developed support structure are respectively fixed to both ends of the balloon body.

[0018] Preferably, the surfaces at both ends of the dilation and cutting structure form an oblique angle with the balloon body.

[0019] Preferably, the degree of the oblique angle is 10° - 85°.

[0020] Preferably, adhesives are provided at both ends of the dilation and cutting structure; both ends of the developed support structure are connected to both ends of the cutting wire through the adhesives.

[0021] Preferably, the number of the dilation and cutting structures is 1 - 10; the part of the cutting wire in contact with the balloon body is fixedly matched with the outer surface of the balloon body in shape.

[0022] Preferably, the width of the part of the cutting wire in contact with the balloon body is 0.2 - 3 mm.

[0023] Preferably, the cross-section of the cutting wire is polygonal, and the top end away from the balloon body is designed with a sharp angle.

[0024] Preferably, the distance between the top end of the cutting wire and the balloon body is 0.1 - 2 mm; the wall thickness of the cross-section of the cutting wire is 0.01 - 3 mm.

[0025] Preferably, the cutting wire is an elastic cutting wire; the developed support structure is an elastic developed support structure.

[0026] Preferably, the developed support structure is a developed spring or includes a support tube and a developed wire arranged inside the support tube.

[0027] The present invention provides a fully radiopaque and force-concentrating balloon for dilating vascular stenosis, comprising: a balloon body; an expansion cutting structure longitudinally arranged on the outer surface of the balloon body; the expansion cutting structure includes a hollow cutting wire and a radiopaque support structure arranged inside the cutting wire; the cutting wire is fixed to the outer surface of the balloon body; and both ends of the radiopaque support structure are respectively fixed to both ends of the balloon body. Compared with the prior art, the balloon provided by the present invention consists of a hollow cutting wire and a radiopaque support structure arranged inside the cutting wire to form an expansion cutting structure, so that the overall cutting part of the expansion balloon can be radiopaque under X-ray, making the positioning of the cutting component more accurate. At the same time, it can also provide effective support for the cutting wire, thus taking into account both the flexibility and passability of the balloon and further improving the expansion cutting effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 is a schematic structural diagram of the fully radiopaque and force-concentrating balloon for dilating vascular stenosis provided by the present invention;

[0029] Figure 2 is a schematic cross-sectional view of the fully radiopaque and force-concentrating balloon for dilating vascular stenosis provided by the present invention;

[0030] Figure 3 is a schematic diagram of the expansion cutting structure provided by the present invention;

[0031] Figure 4 is a schematic diagram of the expansion cutting structure provided by the present invention;

[0032] Figure 5 is a schematic cross-sectional view of the cutting wire provided by the present invention;

[0033] Figure 6 is a schematic cross-sectional view of the cutting wire provided by the present invention;

[0034] Figure 7 is a schematic structural diagram of the fully radiopaque and force-concentrating balloon for dilating vascular stenosis provided by the present invention;

[0035] Figure 8 is a schematic structural diagram of the fully radiopaque and force-concentrating balloon for dilating vascular stenosis provided by the present invention;

[0036] Figure 9 is a schematic structural diagram of the fully radiopaque and force-concentrating balloon for dilating vascular stenosis provided by the present invention;

[0037] Figure 10 is a schematic structural diagram of the "Flextome Cutting Balloon";

[0038] Figure 11 is a schematic diagram of the ceramic vascular calcification model used in the embodiment of the present invention;

[0039] Figure 12 Schematic diagram of the structure after the cutting balloon extends into the blood vessel calcification model;

[0040] Figure 13 Photo of the fully radiopaque and force-concentrating blood vessel stenosis dilation balloon provided in Embodiment 1 of the present invention after being used in the blood vessel calcification model;

[0041] Figure 14 Photo of the ceramic-made simulated blood vessel path in the present invention. Detailed implementation manners

[0042] Next, in combination with the embodiments of the present invention, the technical solutions in the embodiments of the present invention will be clearly and completely described. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0043] The present invention provides a fully radiopaque and force-concentrating blood vessel stenosis dilation balloon, including: a balloon body; an expansion and cutting structure longitudinally arranged on the outer surface of the balloon body; the expansion and cutting structure includes a hollow cutting wire and a radiopaque support structure arranged inside the cutting wire; the cutting wire is fixed on the outer surface of the balloon body; both ends of the radiopaque support structure are respectively fixed at both ends of the balloon body.

[0044] See Figure 1 And Figure 2 , Figure 1 Schematic diagram of the structure of the fully radiopaque and force-concentrating blood vessel stenosis dilation balloon provided by the present invention, Figure 2 Cross-sectional schematic diagram of the fully radiopaque and force-concentrating blood vessel stenosis dilation balloon provided by the present invention, where 100 is the balloon body and 200 is the expansion and cutting structure.

[0045] According to the present invention, the balloon body is preferably a nylon balloon body or a polyether block amide balloon body; the balloon body is preferably made of nylon (PA) or polyether block amide (PEBAX) extruded into a single-chamber tube as the raw material of the balloon body, and then thermally blow-molded on a balloon molding machine with a convex mold; the outer diameter of the balloon body is preferably 1-30 mm, more preferably 2-20 mm, still more preferably 2-10 mm, and most preferably 3-8 mm; the length of the balloon body is preferably 5-180 mm, more preferably 10-150 mm, still more preferably 20-100 mm.

[0046] The outer surface of the balloon body is longitudinally provided with an expansion cutting structure, i.e., the expansion cutting structure is arranged in the direction from the proximal end to the distal end of the balloon body; the number of the expansion cutting structures is preferably 1 to 10, more preferably 3 to 8, and still more preferably 3 to 5; when the number of the expansion cutting structures is greater than or equal to 2, they are preferably evenly distributed on the outer surface of the balloon body. The expansion cutting structure includes a hollow cutting wire and a developing support structure arranged inside the cutting wire. See Figure 3 and Figure 4 , Figure 3 and Figure 4 are schematic diagrams of the expansion cutting structure provided by the present invention, Figure 3 in which 211 is the cutting wire and 212 is the developing support structure, Figure 4 in which 221 is the cutting wire, 222 is the support tube, and 223 is the developing wire.

[0047] In the present invention, the hollow cutting wire is preferably a hollow elastic cutting wire; the material of the hollow cutting wire is preferably stainless steel, nickel-iron alloy, tungsten, platinum-tungsten alloy or high-strength polymer material; the high-strength polymer material is preferably a polymer material with good biocompatibility such as polyamide or polyethylene; the hollow cutting wire can be a hollow cutting wire formed by single wire or multi-wire winding, or a hollow cutting wire formed by cutting a pipe, without special limitation; when the cutting wire is a hollow cutting wire formed by single wire or multi-wire winding, its pitch is preferably 0.03 - 0.2 mm, more preferably 0.05 - 0.15 mm, still more preferably 0.08 - 0.1 mm; the cross-section of the cutting wire is preferably a polygon, more preferably a 3 - 10-sided polygon, still more preferably a 3 - 8-sided polygon, and most preferably a 3 - 5-sided polygon; each side of the polygon can be a straight line or a curve, without special limitation; the top end of the cross-section of the cutting wire away from the balloon body is preferably designed with a sharp angle; having a sharp angle design at the top end is beneficial for dilation and cutting; the distance between the top end of the cutting wire and the balloon body, that is, the height of the cutting wire, is preferably 0.1 - 2 mm, more preferably 0.3 - 1.5 mm, still more preferably 0.3 - 1 mm, still more preferably 0.3 - 0.8 mm, and most preferably 0.3 - 0.5 mm; the wall thickness of the cross-section of the cutting wire (when the cutting wire is formed by single wire or multi-wire winding, the wall thickness is the diameter of the winding wire; when the cutting wire is formed by cutting a pipe, the wall thickness is the wall thickness of the cutting pipe) is preferably 0.01 - 0.3 mm, more preferably 0.03 - 0.2 mm, still more preferably 0.03 - 0.1 mm, and most preferably 0.03 - 0.05 mm; the cutting wire is fixed on the outer surface of the balloon body, more preferably fixed in the effective dilation area of the balloon body; the length of the cutting wire is preferably 2 - 150 mm, more preferably 8 - 120 mm, still more preferably 18 - 80 mm; the fixing method is preferably by hot melting, adhesion or mechanical fixing, and more preferably fixed on the outer surface of the balloon body by an adhesive, and most preferably fixed on the outer surface of the balloon body by a UV curable adhesive; the part of the cutting wire in contact with the balloon body is fixedly matched with the outer surface of the balloon body in shape; after the matching fixing, it has excellent connectivity and can prevent falling off during use; the width of the part of the cutting wire in contact with the balloon body (that is, the bottom length of the cross-section of the cutting wire opposite to the top end) is preferably 0.2 - 3 mm, more preferably 0.2 - 2 mm, still more preferably 0.3 - 1 mm, and most preferably 0.3 - 0.8 mm; see Figure 5 and Figure 6 , Figure 5 and Figure 6 is a schematic cross-sectional view of the cutting wire provided by the present invention, where a is the top end of the cutting wire, b is the side of the cutting wire, c is the bottom surface of the cutting wire in contact with the balloon body, and 001 - 005 respectively represent different polygons.

[0048] A developing support structure is disposed inside the hollow cutting wire; the developing support structure is preferably an elastic developing support structure, more preferably a developing spring or includes a support tube and a developing wire disposed inside the support tube. On the one hand, the developing support structure can provide a developing function, making the cutting position of the balloon visible throughout the expansion process under X-ray, and on the other hand, it also provides good support for the hollow cutting wire, enabling the expansion cutting structure to have a good mechanical structure and preventing deformation during the expansion cutting process.

[0049] When the developing support structure is a developing spring, the cross-section of the developing spring is preferably circular, elliptical or polygonal; the number of sides of the polygon is preferably 3 to 10, more preferably 3 to 8, still more preferably 3 to 5; the height of the cross-section of the developing spring is preferably 0.05 to 1 mm, more preferably 0.1 to 0.8 mm, still more preferably 0.1 to 0.5 mm, and most preferably 0.1 to 0.3 mm; the width of the cross-section of the developing spring is preferably 0.05 to 1 mm, more preferably 0.1 to 0.8 mm, still more preferably 0.1 to 0.5 mm, and most preferably 0.1 to 0.3 mm; the length of the developing spring is preferably 2 to 160 mm, more preferably 10 to 140 mm, still more preferably 20 to 120 mm; the developing spring can be wound from a wire or cut from a tube; when the developing spring is wound from a wire, the diameter of the wire is preferably 0.01 to 0.2 mm, more preferably 0.02 to 0.15 mm, still more preferably 0.02 to 0.1 mm, still more preferably 0.02 to 0.08 mm, and most preferably 0.02 to 0.05 mm; when the developing spring is cut from a tube, the wall thickness of the tube is preferably 0.01 to 0.2 mm, more preferably 0.02 to 0.15 mm, still more preferably 0.02 to 0.1 mm, still more preferably 0.02 to 0.08 mm, and most preferably 0.02 to 0.05 mm; the material of the developing spring is a material well-known to those skilled in the art that has elasticity and can be developed under X-ray, without special limitations. In the present invention, it is preferably gold, platinum, platinum-tungsten alloy, platinum-iridium alloy, tungsten or tungsten alloy.

[0050] When the developing support structure includes a support tube and a developing wire disposed within the support tube, the support tube is preferably a polymer tube with elasticity; the cross-section of the polymer tube is preferably circular, elliptical or polygonal; the number of sides of the polygon is preferably 3 to 10, more preferably 3 to 8, still more preferably 3 to 5; the height of the cross-section of the polymer tube is preferably 0.05 to 1 mm, more preferably 0.1 to 0.8 mm, still more preferably 0.1 to 0.5 mm, and most preferably 0.1 to 0.3 mm; the width of the polymer tube is preferably 0.05 to 1 mm, more preferably 0.1 to 0.8 mm, still more preferably 0.1 to 0.5 mm, and most preferably 0.1 to 0.3 mm; the length of the polymer tube is preferably 2 to 160 mm, more preferably 10 to 140 mm, still more preferably 20 to 120 mm; a developing wire is disposed within the polymer tube; the diameter of the developing wire is preferably 0.01 to 0.5 mm, more preferably 0.02 to 0.3 mm, still more preferably 0.02 to 0.2 mm, still more preferably 0.02 to 0.1 mm, and most preferably 0.03 to 0.05 mm; the length of the developing wire is preferably 2 to 160 mm, more preferably 10 to 140 mm, still more preferably 20 to 120 mm; the material of the developing wire is a material well-known to those skilled in the art that has elasticity and can be developed under X-ray, and there is no special limitation. In the present invention, it is preferably gold, platinum, platinum-tungsten alloy, platinum-iridium alloy, tungsten or tungsten alloy.

[0051] In the present invention, both ends of the developing support structure are fixed to both ends of the balloon body, and it can be fixed to both ends of the balloon body through cutting wires, or directly fixed to both ends of the balloon body.

[0052] To prevent stress concentration during use and further improve the flexibility and passability of the fully developed and cohesive balloon for vascular stenosis dilation, the surfaces at both ends of the developing support structure form an oblique angle with the balloon body, that is, both ends of the cutting wire and the surfaces at both ends of the developing support structure form an oblique angle with the balloon body; see Figure 7 and Figure 8 , Figure 7 and Figure 8 are schematic structural diagrams of the fully developed and cohesive balloon for vascular stenosis dilation provided by the present invention, where 100 is the balloon body, 200 is the dilation cutting structure, 221 is the cutting wire, and 212 is the developing support structure; the degree of the oblique angle is preferably 10° to 85°, more preferably 25° to 60°.

[0053] Furthermore, adhesives are provided at both ends of the dilation cutting structure, and both ends of the developing support structure are connected to both ends of the cutting wire through the adhesives; the adhesives seal both ends of the hollow cutting wire to form a glue slope, and the angle between this slope and the outer surface of the balloon body is preferably 10° to 85°. See Figure 9 ,Figure 9 This is a schematic structural diagram of the fully visible and focused vascular stenosis dilation balloon provided by the present invention. Among them, 100 is the balloon body, and 200 is the dilation and cutting structure. The glue slope forms a buffer structure, enabling a smooth transition at the connection and fixation of the dilation and cutting structure to the balloon body, preventing stress concentration during use, improving the flexibility and deliverability of the balloon, facilitating passage through the diseased site, and reducing the surgical risk.

[0054] The balloon provided by the present invention consists of a hollow cutting wire and a visible support structure arranged inside the cutting wire to form a dilation and cutting structure. As a result, the overall cutting part of the dilation balloon can be visible under X-ray, making the positioning of the cutting component more accurate. At the same time, it can also provide effective support for the cutting wire, thus taking into account both the flexibility and passability of the balloon and further improving the dilation and cutting effect.

[0055] To further illustrate the present invention, the following is a detailed description of a fully visible and focused vascular stenosis dilation balloon provided by the present invention in combination with embodiments.

[0056] All reagents used in the following embodiments are commercially available.

[0057] Embodiment 1

[0058] As Figure 1 shown, the fully visible and focused vascular stenosis dilation balloon in this embodiment consists of a balloon body 100 with an outer diameter of 8 mm and a length of 60 mm and three dilation and cutting structures 200 longitudinally arranged along the outer surface of the balloon body. As Figure 3 shown, the dilation and cutting structure 200 consists of an outer cutting wire (wire winding) 211 and a visible spring 212. The cross-section of the outer cutting wire 211 is an isosceles triangle with a height of 0.5 mm and a width of 0.8 mm, a length of 56 mm, and is wound by a nitinol wire with a wire diameter of 0.05 mm, and the pitch is 0.08 mm, having excellent material properties and shape structures; the cross-section of the visible spring 212 is circular with an outer diameter of 0.3 mm and is made of a platinum-iridium alloy with a wire diameter of 0.03 mm, adding a visible effect to the balloon and providing more structural support for the outer cutting wire 211, further optimizing and enhancing the dilation and cutting ability of the dilation and cutting structure 200.

[0059] Respectively, a "Flextome Cutting Balloon" cutting balloon structure with an outer diameter of 8 mm, a length of 60 mm, and a balloon outer surface composed of multiple blades from Boston Scientific as Figure 10 shown, and the fully visible and focused vascular stenosis dilation balloon with an outer diameter of 8 mm and a length of 60 mm described in Embodiment 1 are inserted into Figure 11 a vascular calcification model 300 made of soft porcelain with an inner diameter of 7.5 mm and an outer diameter of 12 mm as Figure 12, when pressurized to 20 atmospheres respectively, all the vascular calcification models 300 were fragmented. After depressurization, observing the cutting contact surface of the cutting blade of the "Flextome CuttingBalloon" cutting balloon structure, obvious damage was found; at the same time, observing the outer cutting wire 211 of the present invention as Figure 13 , the cutting contact surface was intact and no obvious damage was seen, and the stability of its cutting functional components was significantly better than that of the control group.

[0060] Example 2

[0061] As Figure 1 shown, this fully radiopaque and force-concentrating vascular stenosis dilation balloon consists of a balloon body 100 with an outer diameter of 5 mm and a length of 100 mm and 5 dilation cutting structures 200 longitudinally arranged along the outer surface of the balloon body, and the cross-section is as Figure 2 . As Figure 4 shown, the dilation cutting structure consists of an outer cutting wire (pipe cutting) 221, an inner support tube 222 and an inner radiopaque wire 223. The outer cutting wire 221 is triangular with a tip angle of 40°, a height of 0.3 mm, and a length of 80 mm, and is cut from a stainless steel 304V tube with a wall thickness of 0.04 mm. The cutting tube is in a hollow structure to make it have good flexibility; the inner support tube 222 is a silicone tube with a circular outer diameter of 0.18 mm, an inner diameter of 0.05 mm, and a length of 85 mm, providing more structural support for the outer cutting wire 221 and further enhancing the dilation cutting ability of the dilation cutting structure 200; the inner radiopaque wire 223 is a gold wire with a purity of 95% and a diameter of 0.05 mm and a length of 86 mm, providing excellent radiopaque effect for the present invention.

[0062] Respectively use a guide wire to insert the "Flextome Cutting Balloon" cutting balloon structure with an outer diameter of 5 mm and a length of 100 mm from Boston Scientific, and the balloon surface is composed of multiple blades, as Figure 10 , and the fully radiopaque and force-concentrating vascular stenosis dilation balloon with an outer diameter of 5 mm and a length of 100 mm described in Example 2 into the Figure 8 simulated vascular access, and observe and compare their flexibility and passability. It is found that the fully radiopaque and force-concentrating vascular stenosis dilation balloon in Example 2 has better overall flexibility and passability than the control group because all the components in the dilation cutting structure 200 on the balloon surface are made of raw materials or structures with better flexibility.

[0063] Example 3

[0064] As Figure 1 shown, this fully radiopaque and force-concentrating vascular stenosis dilation balloon has 3 dilation cutting structures 200 fixed on a balloon body 100 with an outer diameter of 4 mm and a length of 80 mm by UV curable glue, as Figure 9As shown, the two ends of the expansion cutting structure 200 have a buffer bevel after curing, with an angle of 25°, which prevents stress concentration during use and effectively improves the product's passing performance. Figure 4 The expansion cutting structure consists of an outer cutting wire 221, an inner supporting tube 222 and an inner developing wire 223. The outer cutting wire (tube cutting) 221 is an equilateral triangle with a height of 0.4mm and a length of 70mm. It is cut from a stainless steel 316 tube with a wall thickness of 0.05mm and has excellent material properties and appearance structure. The inner supporting tube 222 is a triangle. The outer dimension of the triangle is consistent with the inner dimension of the outer cutting wire. It is a nylon tube with an inner diameter of 0.06mm and a length of 75mm, which provides more structural support for the outer cutting wire 221 and further enhances the expansion cutting ability of the expansion cutting structure 200. The inner developing wire 223 is a platinum wire with a purity of more than 99% with a diameter of 0.04mm and a length of 70mm, providing excellent developing effect.

[0065] The Boston Scientific "Flextome Cutting Balloon" with an outer diameter of 4 mm and a length of 80 mm and a balloon surface composed of multiple blades was used to cut the balloon structure. Figure 10 , a fully developed focused vascular stenosis dilatation balloon with an outer diameter of 4 mm and a length of 80 mm as described in Example 3 is inserted into Figure 14 The Flextome Cutting Balloon was made of ceramic, with an inner diameter of 3.8 mm and a length of 200 mm to simulate the blood vessel path, from the proximal end to the distal end, and then from the distal end to the proximal end until it was withdrawn, and repeated 10 times. The connection between the cutting blade and the balloon body of the "Flextome Cutting Balloon" cutting balloon structure was observed, and it was found that some blades were loose; at the same time, it was observed that the expansion cutting structure 200 of the present invention was not loose, its structural shape remained intact, and there was no collapse at the top a of the cutting wire. Its connection strength and effect were significantly better than those of the control group.

[0066] Example 4

[0067] like Figure 7 As shown in FIG. 1 , the fully developed focused vascular stenosis dilatation balloon of this embodiment is composed of four dilatation cutting structures 200 fixed on a balloon body 100 with an outer diameter of 3 mm and a length of 20 mm by UV curing glue. Figure 9 After solidification, both ends of the expansion cutting structure 200 have a buffer bevel angle of 60° to prevent stress concentration during use and effectively improve the product's passing performance. Figure 8The expansion cutting structure shown is composed of an outer cutting wire 221 (tube cutting) and a developing spring 212. The outer cutting wire (tube cutting 221 is an isosceles triangle with a height of 0.32 mm, a width of 0.36 mm, and a length of 18 mm. It is cut from a platinum-tungsten alloy tube with a wall thickness of 0.03 mm. The tube wall is a continuous spiral hollow structure with good flexibility. Both ends are inclined structures with excellent material properties and appearance structure; the inner developing spring 212 is a circular outer diameter of 0.16 mm. It is wound from 0.02 mm gold wire. Both ends are inclined structures, which provide more structural support for the outer cutting wire 221, further enhance the expansion cutting ability of the expansion cutting structure 200, and provide excellent developing effect.

[0068] The Boston Scientific "Flextome Cutting Balloon" with an outer diameter of 3 mm and a length of 20 mm and a balloon surface composed of multiple blades was used to cut the balloon structure. Figure 10 , and the fully developed focused vascular stenosis dilatation balloon with an outer diameter of 3 mm and a length of 30 mm described in Example 4 was repeatedly pushed into the Figure 14 In the simulated vascular path shown, the flexibility and passability of the two are observed and recorded, as shown in Table 1. By comparison, it is found that the fully developed focused vascular stenosis dilatation balloon of the present invention is significantly better than the control group in overall flexibility and passability because the components in the balloon surface dilatation cutting structure 200 are made of raw materials or structures with good flexibility; the components in the dilatation cutting structure 200 and the two ends of the components are inclined structures, and both ends have buffer bevels after being fixed with UV curing glue, which avoids stress concentration during the product pushing process and facilitates smooth arrival at the embolization area. It can be seen from the table below that the overall passability of the product of the present invention is also significantly better than the control group.

[0069] Table 1 Softness and passability test record

[0070]

[0071]

Claims

1. A fully developed and force-concentrating blood vessel stenosis dilation balloon, characterized in that, Comprising: A balloon body; An expansion cutting structure longitudinally arranged along the outer surface of the balloon body; The expansion cutting structure includes a hollow cutting wire and a developing support structure arranged inside the cutting wire; The cutting wire is fixed to the outer surface of the balloon body; Both ends of the developing support structure are respectively fixed to both ends of the balloon body; The cross-section of the cutting wire is polygonal, and the top end away from the balloon body is designed with a sharp angle; The cutting wire is an elastic cutting wire; The developing support structure is an elastic developing support structure; The hollow cutting wire is a hollow cutting wire wound by a single wire or multiple wires, or a hollow cutting wire cut from a pipe; The developing support structure is a developing spring or includes a support tube and a developing wire arranged inside the support tube; The surfaces at both ends of the expansion cutting structure form an oblique angle with the balloon body.

2. The fully developed focusing blood vessel stenosis dilation balloon according to claim 1, wherein The degree of the oblique angle is 10° - 85°.

3. The fully developed and focused blood vessel stenosis dilation balloon according to claim 1, wherein Adhesives are arranged at both ends of the expansion cutting structure; both ends of the developing support structure are connected to both ends of the cutting wire through adhesives.

4. The fully developed focusing balloon for blood vessel stenosis dilation according to claim 1, wherein The number of the expansion cutting structures is 1 - 10; the part of the cutting wire in contact with the balloon body is fixedly matched with the outer surface of the balloon body in shape.

5. The fully developed focusing balloon for blood vessel stenosis dilation according to claim 4, characterized in that, The width of the part of the cutting wire in contact with the balloon body is 0.2 - 3 mm.

6. The fully developed and focused vascular stenosis dilation balloon according to claim 1, wherein The distance between the top end of the cutting wire and the balloon body is 0.1 - 2 mm; the wall thickness of the cross-section of the cutting wire is 0.01 - 3 mm.

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