A cutting balloon catheter

Abstract

The present invention relates to the technical field of medical balloon catheters, and provides a cutting balloon catheter, comprising: a tube body, a balloon, a delivery channel, and a cutter; the tube body comprises: a proximal end and a distal end; the balloon is arranged on the tube body between the proximal end and the distal end; the delivery channel is used to deliver the medium injected into the balloon; the delivery channel is arranged in the tube body, and one end of the delivery channel is connected to the balloon; and the cutter is arranged on the outer surface of the balloon. A cutter is arranged on the outer surface of the balloon, and a smaller pressure can be used during balloon expansion to achieve a greater pressure in the middle position, so that the stress is concentrated on the blade in the middle position of the balloon, forming a more effective incision on the plaque or diseased tissue in the blood vessel, and the balloon can stretch the vascular plaque or the inner wall of the blood vessel along the incision during the expansion process, so as to avoid irregular tearing of the plaque or the inner wall of the blood vessel during the expansion process.

Description

Technical Field

[0001] The invention belongs to the technical field of medical balloon catheters, and more specifically, relates to a cutting balloon catheter. Background Art

[0002] Percutaneous transluminal angioplasty (PTA) and percutaneous transluminal coronary angioplasty (PTCA) are interventional treatments that are mainly used to treat arterial stenosis or occlusion. They are performed by inserting a catheter into a blood vessel and using a balloon to dilate the stenotic area, thereby restoring the patency of the blood vessel. This method is commonly used to treat coronary artery disease, peripheral vascular disease, etc. It is a widely used and effective revascularization procedure. However, since the mechanism of ordinary balloon angioplasty is to cause compression and rupture of vascular plaques in the stenotic segment and expansion of vascular elasticity through balloon expansion, irregular tearing of vascular plaques or intima is prone to occur. The incidence of restenosis is about 25% to 40% 3 to 6 months after balloon dilatation. In recent years, the implantation of stents has not only significantly reduced the incidence of restenosis, but also significantly reduced severe postoperative complications, but in-stent restenosis is still an unresolved problem. Summary of the invention

[0003] The purpose of the present invention is to provide a cutting balloon catheter to solve the technical problem in the prior art that vascular plaques or irregular tearing of the endothelium are easily caused during the expansion process of ordinary balloons.

[0004] To achieve the above object, the technical solution adopted by the present invention is: to provide a cutting balloon catheter, comprising:

[0005] The tube body comprises a proximal end and a distal end;

[0006] A balloon; the balloon is arranged on the tube body between the proximal end and the distal end;

[0007] A delivery channel; the delivery channel is used to deliver the medium injected into the balloon; the delivery channel is arranged in the tube body, and one end of the delivery channel is connected to the balloon; and

[0008] A cutter; the cutter is disposed on the outer surface of the balloon.

[0009] Furthermore, it also includes: a guide wire channel; the guide wire channel is arranged in the tube body; and the balloon is wrapped around the outside of the guide wire channel.

[0010] Furthermore, the tube body includes: an inner tube and an outer tube sleeved on the outside of the inner tube; the lumen inside the inner tube forms the guide wire channel, the inner tube and the outer tube are spaced apart, and the delivery channel is formed between the inner tube and the outer tube; the balloon is wrapped around the outside of the inner tube and / or the outer tube.

[0011] Furthermore, it also includes: a developing ring; the developing ring is arranged on the inner tube inside the balloon.

[0012] Furthermore, it also includes: a first catheter seat, a first stress relief tube and a metal tube; the first catheter seat is connected to the tube body through the first stress relief tube and the metal tube in sequence; the first catheter seat has a first injection port connected to the delivery channel.

[0013] Furthermore, it also includes: a second catheter seat and a second stress relief tube; the second catheter seat is connected to the tube body through the second stress relief tube; the second catheter seat has a second injection port connected to the delivery channel, and the second catheter seat has an entry port connected to the guide wire channel.

[0014] Furthermore, the balloon is made of: polyether block polyamide, polyamide, thermoplastic polyurethane elastomer, thermoplastic elastomer, polyethylene terephthalate, polyvinyl chloride, polyethylene, silicone, rubber, latex or a mixture thereof.

[0015] Furthermore, the cutter is fixed on the outer surface of the balloon.

[0016] Furthermore, the cutter is a blade.

[0017] Furthermore, the blade is bonded to the outer surface of the balloon.

[0018] Furthermore, it also includes: a base fixed on the surface of the balloon; the blade has an insertion portion inserted into the insertion hole on the base.

[0019] Furthermore, the base is provided with a glue injection hole; the glue injection hole is communicated with the insertion hole, and the insertion part is glued in the insertion hole.

[0020] Furthermore, the base has a U-shaped curved surface for being attached to and bonded to the balloon.

[0021] Furthermore, the blade is U-shaped.

[0022] Furthermore, a reinforcing rib is connected to one end of the U-shaped blade close to the balloon.

[0023] Furthermore, there are multiple reinforcing ribs.

[0024] Furthermore, the balloon is ellipsoidal or spherical; the number of the blades is multiple; and the multiple blades are arranged on the balloon in a surrounding and spaced manner.

[0025] Furthermore, the number of the blades is four.

[0026] Furthermore, two of the blades are located at opposite ends of the balloon, and the other two blades are located at opposite ends of the balloon.

[0027] Furthermore, in the extension direction of the tube body, a plurality of rows of blades are arranged on the surface of the balloon, and each row of blades has two to six blades.

[0028] Furthermore, the blade is made of one or more of stainless steel, nickel-titanium alloy, aluminum alloy, carbon steel, titanium alloy, and ceramic.

[0029] Furthermore, part or all of the blade edge of the blade is wavy.

[0030] Furthermore, the blade is in the shape of a flat plate; the blade includes: a first cutting edge and a second cutting edge adjacent to the first cutting edge; the edge of the first cutting edge extends along a predetermined straight line, and the edge of the second cutting edge is wavy.

[0031] Further, a plane parallel to the blade is set as: a first projection plane; the projection of the predetermined straight line in the first projection plane is: the horizontal axis of the rectangular coordinate system in the first projection plane; the projection of the intersection of the first blade edge and the second blade edge on the first projection plane is the origin; the projection of the second blade edge on the first projection plane is: ; ;in

[0032] , , are values ​​greater than zero.

[0033] Further, a plane parallel to the blade is set as: a second projection plane; the projection of the predetermined straight line in the second projection plane is: the horizontal axis of the rectangular coordinate system in the second projection plane; the projection of the intersection of the first blade edge and the second blade edge on the second projection plane is the origin; the projection of the second blade edge on the second projection plane is: ; ;in

[0034] , , , , are values ​​greater than zero.

[0035] Further, a plane parallel to the blade is set as: a third projection plane; the projection of the predetermined straight line in the third projection plane is: the horizontal axis of the rectangular coordinate system in the third projection plane; the projection of the intersection of the first blade edge and the second blade edge on the third projection plane is the origin; the projection of the second blade edge on the third projection plane is: ; ;in

[0036] , , , , are values ​​greater than zero.

[0037] Further, a plane parallel to the blade is set as: a fourth projection plane; the projection of the predetermined straight line in the fourth projection plane is: the horizontal axis of the rectangular coordinate system in the fourth projection plane; the projection of the intersection of the first blade edge and the second blade edge on the fourth projection plane is the origin; the projection of the second blade edge on the fourth projection plane is: ; ;in,

[0038] , , , , , , , , , are values ​​greater than zero.

[0039] Furthermore, a recessed portion with an annular edge is provided on the outer wall of the blade outside the blade.

[0040] Furthermore, the inner wall of the recessed portion is wavy.

[0041] Further, a plane parallel to the blade is set as the fifth projection plane; the projection of the predetermined straight line in the fifth projection plane is the first reference line; the center of the projection of the recessed portion on the fifth projection plane is the origin; the straight line passing through the origin and parallel to the first reference line is the horizontal axis of the rectangular coordinate system in the fifth projection plane; the three-dimensional distribution of the inner wall of the recessed portion is: ; ;in,

[0042] , , , , are values ​​greater than zero.

[0043] Further, a plane parallel to the blade is set as the sixth projection plane; the projection of the predetermined straight line in the sixth projection plane is the second reference line; the center of the projection of the recessed portion on the sixth projection plane is the origin; the straight line passing through the origin and parallel to the second reference line is the horizontal axis of the rectangular coordinate system in the sixth projection plane; the three-dimensional distribution of the inner wall of the recessed portion is: ; ;in,

[0044] , , , , , , , , , , are values ​​greater than zero.

[0045] Furthermore, a T-shaped hollow hole is provided on the blade.

[0046] Furthermore, the corners of the T-shaped hollow holes are smoothly connected.

[0047] The beneficial effects of the cutting balloon catheter provided by the present invention are as follows: compared with the prior art, the cutting balloon catheter provided by the present invention has a proximal end and a distal end at both ends of the tube body, and an ellipsoidal or spherical balloon is arranged between the proximal end and the distal end; a cutter is arranged on the outer surface of the balloon, and a smaller pressure can be used during balloon expansion to achieve a higher pressure in the middle position, so that the stress is concentrated on the blade in the middle position of the balloon, and a lower pressure is achieved to achieve a cutting effect, reducing the damage of local high pressure to the blood vessel, improving the effect and safety of expansion, forming a more effective incision on the plaque or diseased tissue in the blood vessel, and the balloon can expand the vascular plaque or the inner wall of the blood vessel along the incision during the expansion process, avoiding irregular tearing of the plaque or the inner wall of the blood vessel during the expansion process. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] Figure 1 A schematic front view of a cutting balloon catheter provided by an embodiment of the present invention;

[0049] Figure 2 for Figure 1 Enlarged view of point A in the middle;

[0050] Figure 3 for Figure 2 Middle BB cross section (in Figure 2 Add a base on the basis of

[0051] Figure 4 A cross-sectional schematic diagram of a cutter and a base provided in an embodiment of the present invention;

[0052] Figure 5 A schematic front view of a cutter provided in an embodiment of the present invention;

[0053] Figure 6 A schematic diagram of assembling a second catheter seat provided by an embodiment of the present invention;

[0054] Figure 7 A schematic diagram of the assembly of a first catheter seat provided by an embodiment of the present invention;

[0055] Figure 8 for Figure 7 Enlarged view of point C in the middle;

[0056] Fig. 9 A front view schematic diagram of a cutter provided in an embodiment of the present invention.

[0057] Among them, the reference numerals in the figure are:

[0058] 1-tube body; 11-proximal end; 12-distal end; 13-outer tube; 14-inner tube; 15-delivery channel; 16-guidewire channel; 17-T-shaped hollow hole; 2-balloon; 3-cutter; 31-insertion part; 32-blade; 321-first blade; 322-second blade; 41-first catheter seat; 411-first injection port; 42-first stress relief tube; 43-metal tube; 431-marking ring; 51-second catheter seat; 511-second injection port; 512-entry port; 52-second stress relief tube; 61-developing ring; 62-base; 621-glue injection hole; 622-U-shaped curved surface. DETAILED DESCRIPTION

[0059] It should be noted that the specific embodiments are only used to explain the present invention, and are not used to limit the present invention.

[0060] It should be noted that, in the description of the embodiments of the present application, unless otherwise specified, " / " means or, for example, A / B can mean A or B; "and / or" in this article is only a description of the association relationship of associated objects, indicating that there can be three relationships, for example, A and / or B can mean: A exists alone, A and B exist at the same time, and B exists alone. Among them, A and B can be singular or plural respectively.

[0061] It should be noted that when an element is referred to as being "fixed on" or "set on" another element, it may be directly on the other element or indirectly on the other element. When an element is referred to as being "connected to" or "connected to" another element, it may be directly connected to the other element or indirectly connected to the other element. When an element is referred to as being "fixed on" or "set on" another element, it may be directly on the other element or indirectly on the other element.

[0062] It should be noted that the directions or positional relationships indicated by terms such as “length”, “width”, “up”, “down”, “front”, “back”, “left”, “right”, “vertical”, “horizontal”, “top”, “bottom”, “inside” and “outside” are based on the directions or positional relationships shown in the accompanying drawings and are only for the convenience of describing the present invention and simplifying the description. They do not indicate or imply that the device or element referred to must have a specific direction, be constructed and operated in a specific direction. Therefore, they should not be understood as limiting the present invention.

[0063] It should be noted that the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, features defined as "first" and "second" may explicitly or implicitly include one or more of the features.

[0064] It should be noted that the term "plurality" means two or more than two, unless otherwise clearly and specifically defined.

[0065] Please also read Figures 1 to 5 The cutting balloon catheter provided by the present invention is now described. The cutting balloon catheter comprises: a tube body 1, a balloon 2, a delivery channel 15, and a cutter 3; the tube body 1 comprises: a proximal end 11 and a distal end 12; the balloon 2 is arranged on the tube body 1 between the proximal end 11 and the distal end 12; the delivery channel 15 is used to deliver the medium injected into the balloon 2; the delivery channel 15 is arranged in the tube body 1, and one end of the delivery channel 15 is connected to the balloon 2; the cutter 3 is arranged on the outer surface of the balloon 2.

[0066] In this way, the two ends of the tube body 1 are respectively the proximal end 11 and the distal end 12, and an ellipsoidal or spherical balloon 2 is arranged between the proximal end 11 and the distal end 12; a cutter 3 is arranged on the outer surface of the balloon 2, and a smaller pressure can be used during the expansion of the balloon 2 to make the middle position reach a higher pressure, so that the stress is concentrated on the blade in the middle position of the balloon 2, and a lower pressure is achieved to achieve a cutting effect, reducing the damage of local high pressure to the blood vessel, improving the effect and safety of expansion, forming a more effective incision on the plaque or diseased tissue in the blood vessel, and the balloon 2 can expand the vascular plaque or the inner wall of the blood vessel along the incision during the expansion process, avoiding irregular tearing of the plaque or the inner wall of the blood vessel by the balloon 2 during the expansion process.

[0067] In one embodiment, the medium is a liquid or a gas.

[0068] In one embodiment, the two ends of the tube body 1 are respectively a proximal end 11 and a distal end 12, and a balloon 2 is arranged between the proximal end 11 and the distal end 12; the user can inject a medium into the balloon 2 through the delivery channel 15 to expand the balloon 2; a cutter 3 is arranged on the outer surface of the balloon 2, and the balloon 2 can cut the plaque or diseased tissue in the external blood vessel to form an incision through the cutter 3 during the expansion process, and the balloon 2 can expand the vascular plaque or the inner wall of the blood vessel along the incision during the expansion process.

[0069] In one embodiment, before the balloon 2 is expanded, the balloon 2 can be folded and wrapped around the outside of the cutter 3 .

[0070] For further information, see Figures 1 to 5 As a specific embodiment of the cutting balloon catheter provided by the present invention, it also includes: a guidewire channel 16; the guidewire channel 16 is arranged in the tube body 1; and the balloon 2 is wrapped around the outside of the guidewire channel 16. In this way, the guidewire can pass through the guidewire channel 16 and guide the catheter.

[0071] In one embodiment, the exit of the guidewire channel 16 is located at the distal end 12 .

[0072] For further information, see Figures 1 to 5 As a specific embodiment of the cutting balloon catheter provided by the present invention, the tube body 1 includes: an inner tube 14 and an outer tube 13 sleeved on the outer side of the inner tube 14; the lumen inside the inner tube 14 forms a guidewire channel 16, the inner tube 14 and the outer tube 13 are arranged at intervals, and a delivery channel 15 is formed between the inner tube 14 and the outer tube 13; the balloon 2 is wrapped around the outer side of the inner tube 14 and / or the outer tube 13. In this way, the outer tube 13 can protect the inner tube 14 on the inside, the guidewire can be delivered along the inner tube 14, and the guidewire channel 16 and the delivery channel 15 are isolated from each other to avoid interference between the two.

[0073] For further information, see Figures 1 to 5 As a specific embodiment of the cutting balloon catheter provided by the present invention, it also includes: a developing ring 61; the developing ring 61 is arranged on the inner tube 14 inside the balloon 2. In this way, the user can track the position of the catheter through the developing ring 61.

[0074] For further information, see Figure 7 and Figure 8As a specific embodiment of the cutting balloon catheter provided by the present invention, it also includes: a first catheter seat 41, a first stress relief tube 42 and a metal tube 43; the first catheter seat 41 is connected to the tube body 1 through the first stress relief tube 42 and the metal tube 43 in sequence; the first catheter seat 41 has a first injection port 411 connected to the delivery channel 15. In this way, the first stress relief tube 42 and the metal tube 43 have a certain toughness, which is convenient for stress release; the user can inject the medium into the delivery channel 15 through the first injection port 411.

[0075] In one embodiment, a marking ring 431 is provided on the metal tube 43 , so that the user can determine the position of the metal tube 43 through the marking ring 431 .

[0076] In one embodiment, the developing ring 61 is welded to the inner tube 14 .

[0077] In one embodiment, the metal tube 43 is a hypotube.

[0078] In one embodiment, the distal end 12 has a head end tube; the head end tube is welded to the inner tube 14 and the balloon 2. In one embodiment, the inner tube 14 is inserted from the mounting hole on the side wall of the outer tube 13, and the inner tube 14 and the outer tube 13 are welded and fixed, and a guide wire channel 16 is formed inside the inner tube 14. In one embodiment, the outer tube 13 is welded to the metal tube. In one embodiment, the metal tube 43 is bonded (or overmolded) to the first stress relief tube 42 (and / or the first catheter seat 41).

[0079] For further information, see Figure 6 As a specific embodiment of the cutting balloon catheter provided by the present invention, it also includes: a second catheter seat 51 and a second stress relief tube 52; the second catheter seat 51 is connected to the tube body 1 through the second stress relief tube 52; the second catheter seat 51 has a second injection port 511 connected to the delivery channel 15, and the second catheter seat 51 has an entry port 512 connected to the guide wire channel 16. In this way, the second stress relief tube 52 has a certain toughness, which is convenient for stress release; the user can inject the medium into the delivery channel 15 through the second injection port 511, and the guide wire can enter the guide wire channel 16 through the entry port 512.

[0080] For further information, see Figures 1 to 5As a specific embodiment of the cutting balloon catheter provided by the present invention, the balloon 2 is made of: polyether block polyamide, polyamide, thermoplastic polyurethane elastomer, thermoplastic elastomer, polyethylene terephthalate, polyvinyl chloride, polyethylene, silicone, rubber, latex or a mixture thereof. In this way, the polyether block polyamide and polyamide have excellent mechanical strength and chemical resistance, can withstand high expansion pressure, and ensure that the balloon 2 has sufficient stability and durability when expanding in the blood vessel. Thermoplastic polyurethane elastomers and thermoplastic elastomers provide higher elasticity and flexibility, allowing the balloon 2 to pass flexibly in complex blood vessels and reduce damage to the blood vessel wall; Polyethylene terephthalate (PET): high strength and low compliance, suitable for high-precision and high-pressure operations; Polyvinyl chloride (PVC): soft and economical, suitable for disposable medical devices; Polyethylene (PE): resistant to high pressure, good chemical inertness, used for high-pressure expansion balloons; Silicone, rubber, and latex materials have good biocompatibility, low irritation to tissues, and can effectively reduce the occurrence of allergic reactions and enhance patient safety.

[0081] For further information, see Figures 1 to 5 As a specific embodiment of the cutting balloon catheter provided by the present invention, the cutter 3 is fixed on the outer surface of the balloon 2. In this way, it is very convenient to install the cutter 3, and only the cutter 3 needs to be fixed on the outer surface of the balloon 2.

[0082] For further information, see Figures 1 to 5 As a specific embodiment of the cutting balloon catheter provided by the present invention, the cutter 3 is a blade. Thus, the blade has a simple structure.

[0083] For further information, see Figures 1 to 5 As a specific embodiment of the cutting balloon catheter provided by the present invention, the blade is bonded to the outer surface of the balloon 2. In this way, when installing the blade, it is only necessary to bond the blade to the outer surface of the balloon 2, which is very convenient.

[0084] In one embodiment, the blade is bonded to the outer surface of the balloon 2 by glue.

[0085] For further information, see Figures 1 to 5 As a specific embodiment of the cutting balloon catheter provided by the present invention, it also includes: a base 62 fixed on the surface of the balloon 2; the blade has an insertion portion 31 inserted into the insertion hole on the base 62. In this way, the blade has the insertion portion 31, and the base 62 has the insertion hole. The insertion portion 31 is inserted into the insertion hole to realize the assembly of the blade and the base 62, and the assembly of the blade and the base 62 is very convenient.

[0086] For further information, see Figures 1 to 5As a specific embodiment of the cutting balloon catheter provided by the present invention, the base 62 has a glue injection hole 621; the glue injection hole 621 is connected to the insertion hole, and the insertion part 31 is glued in the insertion hole. In this way, the glue injection hole 621 on the base 62 is connected to the insertion hole, and glue can be injected into the insertion hole through the glue injection hole 621. After the glue is injected into the insertion hole, the blade and the base 62 can be fixed.

[0087] For further information, see Figures 1 to 5 As a specific embodiment of the cutting balloon catheter provided by the present invention, the base 62 has a U-shaped curved surface 622 for attaching and bonding to the balloon 2. In this way, the contact between the base 62 and the balloon 2 is closer.

[0088] For further information, see Figures 1 to 5 As a specific embodiment of the cutting balloon catheter provided by the present invention, the blade is U-shaped. Thus, the U-shaped blade is easily deformed and releases stress when subjected to external force.

[0089] For further information, see Figures 1 to 5 As a specific embodiment of the cutting balloon catheter provided by the present invention, a reinforcing rib is connected to one end of the U-shaped blade close to the balloon 2. In this way, the reinforcing rib can improve the toughness of the blade, and when the blade is subjected to external force, the stress can be dispersed through the reinforcing rib, reducing the risk of the blade breaking.

[0090] For further information, see Figures 1 to 5 As a specific embodiment of the cutting balloon catheter provided by the present invention, the number of reinforcing ribs is multiple. In this way, multiple reinforcing ribs can disperse stress.

[0091] For further information, see Figures 1 to 5 As a specific embodiment of the cutting balloon catheter provided by the present invention, the balloon 2 is ellipsoidal or spherical; the number of blades is multiple; and the multiple blades are arranged around and spaced on the balloon 2. In this way, during the expansion of the balloon 2, the multiple blades can cut the outer blood vessel wall (or intravascular plaque) in different directions.

[0092] For further information, see Figures 1 to 5 As a specific embodiment of the cutting balloon catheter provided by the present invention, the number of blades is four.

[0093] For further information, see Figures 1 to 5 As a specific embodiment of the cutting balloon catheter provided by the present invention, two blades are respectively located at opposite ends of the balloon 2, and the other two blades are respectively located at opposite ends of the balloon 2. In this way, during the expansion process of the balloon 2, the blades at opposite ends of the balloon 2 can move away from each other and cut the inner walls of the blood vessels (or intravascular plaques) on both sides.

[0094] For further information, see Figures 1 to 5 As a specific embodiment of the cutting balloon catheter provided by the present invention, a plurality of rows of blades are arranged on the surface of the balloon 2 in the extension direction of the tube body 1, and each row of blades has two to six blades.

[0095] For further information, see Figures 1 to 5 As a specific embodiment of the cutting balloon catheter provided by the present invention, the blade is made of one or more of stainless steel, nickel-titanium alloy, aluminum alloy, carbon steel, titanium alloy, and ceramic. In this way, stainless steel has excellent corrosion resistance and high strength, so that the blade is not easily affected by oxidation or biological environment when operating in the blood vessel, and is suitable for long-term use. Nickel-titanium alloy has extremely high elasticity and shape memory function, and can restore its original state under extreme deformation, so it can effectively avoid blade breakage or permanent deformation caused by operating errors, and is particularly suitable for use in delicate operations. The light weight and high strength characteristics of aluminum alloy and titanium alloy enable the blade to provide higher cutting accuracy without increasing the burden, reduce fatigue during operation, and enhance the comfort and flexibility of surgery. Carbon steel is known for its excellent hardness and sharpness, which can ensure the long-term sharpness and low wear of the blade, and is suitable for occasions with high precision requirements. Ceramic materials not only have extremely high hardness and sharpness, but also because of their good biocompatibility and rarely cause tissue reactions, they are particularly suitable for use in non-invasive surgeries with extremely high requirements. Combining the advantages of these materials, the blade not only has the wear resistance and corrosion resistance for long-term use, but also can remain sharp in different operating environments, providing precise cutting effects and effectively improving surgical efficiency and safety.

[0096] For further information, see Figures 1 to 5 As a specific embodiment of the cutting balloon catheter provided by the present invention, part or all of the blade 32 of the blade is wavy. In this way, multiple cutting points of the wavy blade 32 can act on different areas of the inner wall of the blood vessel at the same time when force is applied. When the blade applies pressure to the inner wall of the blood vessel and cuts into the inner wall of the blood vessel, the blade 32 between the crest and trough of the wavy blade 32 can achieve a cutting effect.

[0097] In one embodiment, there are a plurality of recessed notches on the edge of the blade 32. In this way, the notches can release stress.

[0098] For further information, see Figures 1 to 5As a specific embodiment of the cutting balloon catheter provided by the present invention, the blade is in the shape of a flat plate; the blade 32 includes: a first blade portion 321 and a second blade portion 322 adjacent to the first blade portion 321; the edge of the first blade portion 321 extends along a predetermined straight line, and the edge of the second blade portion 322 is wavy. In this way, when the blade applies pressure to the inner wall of the blood vessel and cuts into the inner wall of the blood vessel, the second blade portion 322 between the crest and the trough of the wavy second blade portion 322 can achieve a cutting effect.

[0099] For further information, see Figures 1 to 5 As a specific embodiment of the cutting balloon catheter provided by the present invention, a plane parallel to the blade is set as: the first projection plane; the projection of the predetermined straight line in the first projection plane is: the horizontal axis of the rectangular coordinate system in the first projection plane; the projection of the intersection of the edge of the first blade 321 and the edge of the second blade 322 on the first projection plane is the origin; the projection of the edge of the second blade 322 on the first projection plane is: ; ;in , , are respectively a value greater than zero (in one embodiment, In one embodiment, are respectively between 0.1 and 1. In one embodiment, Between 1 and 5. Avoid too much fluctuation. );

[0100] The first projection plane is a plane parallel to the blade; there is a coordinate system in the first projection plane; the horizontal axis of the coordinate system in the first projection plane is: the projection of the predetermined straight line in the first projection plane; the origin of the coordinate system in the first projection plane is: the projection of the intersection of the edge of the first blade 321 and the edge of the second blade 322 on the first projection plane;

[0101] , : The projection of the edge of the second blade 322 on the first projection plane ( is: sine function);

[0102] : Amplitude, which describes the amplitude from the peak to the trough (half the height difference), affects the concentration and dispersion of the cutting force;

[0103] : Wavelength, which describes the distance between adjacent peaks or troughs and affects the periodicity and adaptability of the wave shape;

[0104] : The total length of the projection of the edge of the second blade portion 322 on the first projection plane;

[0105] In this way, (1) the wavy second blade 322 combines the dispersion and concentration of the cutting force; the shape of the wavy second blade 322 is designed through a sine curve, which realizes the combination of dispersion and concentration of the cutting force. When the blade cuts into the target tissue, the crest of the wave first contacts and applies the cutting force, concentrating the force in a limited contact area, thereby achieving efficient cutting. The trough part enters later to avoid the second blade 322 from contacting the tissue too much at one time, thereby reducing the cutting resistance. This distribution can effectively reduce the mechanical load during tissue cutting and improve cutting efficiency. (2) The wavy second blade 322 can adapt to tissues of different hardness; the wavy design increases the flexibility of the blade, enabling it to better adapt to vascular tissues and lesion areas of different hardness. When encountering a harder plaque, the crest of the wave can penetrate first, providing a strong cutting ability; and the trough part gradually cuts in afterwards, evenly dispersing the stress during the cutting process and reducing damage to the surrounding healthy tissue. (3) The wavy second blade 322 can reduce tissue adhesion; the surface of the wavy second blade 322 forms a natural curved surface structure, which can reduce the adhesion of tissue debris during the cutting process compared to a straight blade. During cutting, the curved surface in the trough area guides the vascular tissue to slide rather than stay, thereby reducing adhesion. This feature helps to reduce the frequency of cleaning the second blade 322 and improve surgical efficiency. (4) The wavy second blade 322 can reduce the accumulation of cutting heat; during the cutting process, the wavy second blade 322 can indirectly reduce the accumulation of heat due to the change in contact area. The alternating action of the crest and trough reduces the heat accumulation at a single position, thereby reducing the risk of thermal damage and improving the safety of cutting. (5) The wavy second blade 322 can enhance the strength and fatigue resistance of the blade; the arc structure of the wavy second blade 322 mechanically disperses the force on the blade and avoids the stress concentration point caused by the concentrated force of the straight blade. This design can significantly improve the fatigue resistance of the blade, extend its service life, and reduce the surgical risks caused by blade breakage or deformation. (6) The wavy second blade 322 can adapt to complex blood vessel morphology; when the wavy second blade 322 contacts the inner wall of the blood vessel, its natural curve is more likely to fit the curved shape of the blood vessel, especially in narrow or curved blood vessel areas. This design makes the second blade 322 more flexible in operation in a complex blood vessel environment, thereby improving the accuracy and stability of cutting.

[0106] For further information, see Fig. 9 As a specific embodiment of the cutting balloon catheter provided by the present invention, a plane parallel to the blade is set as: the second projection plane; the projection of the predetermined straight line in the second projection plane is: the horizontal axis of the rectangular coordinate system in the second projection plane; the projection of the intersection of the edge of the first blade 321 and the edge of the second blade 322 on the second projection plane is the origin; the projection of the edge of the second blade 322 on the second projection plane is: ; ;in

[0107] , , , , are respectively a value greater than zero (in one embodiment, In one embodiment, , are respectively between 0.1 and 1. In one embodiment, , They are between 1 and 5. Avoid excessive fluctuations. );

[0108] The second projection plane is a plane parallel to the blade; there is a coordinate system in the second projection plane; the horizontal axis of the coordinate system in the second projection plane is: the projection of the predetermined straight line in the second projection plane; the origin of the coordinate system in the second projection plane is: the projection of the intersection of the edge of the first blade 321 and the edge of the second blade 322 on the second projection plane;

[0109] , is: the projection of the edge of the second blade 322 on the second projection plane ( is: two sine functions superimposed);

[0110] : The total length of the projection of the edge of the second blade portion 322 on the second projection plane;

[0111] For: The first wave (where the first wave: ) represents the amplitude of the first waveform, which defines the height of the first waveform, that is, half the distance between the peak and the trough;

[0112] is: represents the wavelength of the first waveform, that is, the horizontal distance between adjacent peaks or troughs;

[0113] For: The second wave (among which, the second wave: ) represents the amplitude of the second waveform, which defines the height of the second waveform, that is, half the distance between the peak and the trough;

[0114] is: represents the wavelength of the second waveform, that is, the horizontal distance between adjacent peaks or troughs;

[0115] Thus, (1) the wavy second blade 322 can enhance the multi-frequency cutting performance; the superposition of multi-frequency waveforms enables the second blade 322 to have both short-wave (high frequency) and long-wave (low frequency) characteristics. The short-wave portion increases the sharpness of the cutting, allowing the second blade 322 to quickly penetrate the tissue, while the long-wave portion provides a greater cutting depth, achieving a multi-level tissue cutting effect. This design enhances the adaptability of the second blade 322 to complex diseased tissues. (2) The wavy second blade 322 can reduce the slippage phenomenon during cutting; the asymmetric waveform introduces different peaks and troughs, making the force on the second blade 322 more complex during cutting, increasing the tissue gripping ability, effectively reducing the blade slippage phenomenon during cutting, and improving the cutting stability and accuracy. (3) The wavy second blade 322 can optimize the cutting stress distribution; the complex waveform design disperses the stress during cutting, avoiding the problem of stress concentration in certain areas of the blade caused by simple waveforms, thereby reducing the risk of blade breakage or deformation. This design is particularly effective in cutting high-hardness plaques or fibrotic tissues. (4) The wavy second blade portion 322 can enhance the self-cleaning ability of the second blade portion 322; due to the complex structure of the multi-frequency waveform, the accumulation points of tissue debris between the wave crests and the wave troughs are reduced, and the possibility of natural sliding is higher, thereby enhancing the self-cleaning ability of the second blade portion 322 and reducing the frequency of cleaning during surgery.

[0116] For further information, see Fig. 9 As a specific embodiment of the cutting balloon catheter provided by the present invention, a plane parallel to the blade is set as: the third projection plane; the projection of the predetermined straight line in the third projection plane is: the horizontal axis of the rectangular coordinate system in the third projection plane; the projection of the intersection of the edge of the first blade 321 and the edge of the second blade 322 on the third projection plane is the origin; the projection of the edge of the second blade 322 on the third projection plane is: ; ;in

[0117] , , , , are respectively a value greater than zero (in one embodiment, In one embodiment, , are respectively between 0.1 and 1. In one embodiment, , are respectively between 1 and 5. In one embodiment, They are between 0.01 and 1 respectively. Avoid excessive fluctuations. );

[0118] The third projection plane is a plane parallel to the blade; there is a coordinate system in the third projection plane; the horizontal axis of the coordinate system in the third projection plane is: the projection of the predetermined straight line in the third projection plane; the origin of the coordinate system in the third projection plane is: the projection of the intersection of the edge of the first blade 321 and the edge of the second blade 322 on the third projection plane;

[0119] , is: the projection of the edge of the second blade 322 on the third projection plane ( is: two sine functions superimposed);

[0120] : The total length of the projection of the edge of the second blade portion 322 on the third projection plane;

[0121] For: The first wave (where the first wave: ) represents the amplitude of the first waveform, which defines the height of the first waveform, that is, half the distance between the peak and the trough;

[0122] is: represents the wavelength of the first waveform, that is, the horizontal distance between adjacent peaks or troughs;

[0123] For: The second wave (among which, the second wave: ) represents the amplitude of the second waveform, which defines the height of the second waveform, that is, half the distance between the peak and the trough;

[0124] is: represents the wavelength of the second waveform, that is, the horizontal distance between adjacent peaks or troughs;

[0125] : Introducing square into the second term increases the nonlinear characteristics of the waveform;

[0126] : Amplitude attenuation term, indicating that the waveform amplitude gradually decreases with length, controlling the edge smoothness of the blade 32;

[0127] Thus, (1) the wavy second blade 322 can combine precise cutting with progressiveness; the amplitude attenuation term introduced The waveform of the second blade 322 gradually and smoothly transitions at the end, reducing the risk of the second blade 322 cutting too deeply. This design is suitable for more delicate pathological tissue processing. (2) The wavy second blade 322 can adapt to the multi-level of complex tissues; nonlinear square term The asymmetry of the waveform is enhanced, so that the second blade 322 can automatically adjust the cutting depth when it contacts the inner wall of the blood vessel. For harder or fibrotic tissues, the high amplitude area provides strong cutting; while for softer areas, the low amplitude part protects healthy tissue and avoids excessive cutting. (3) The wavy second blade 322 can enhance the self-cleaning effect; the complex waveform further increases the distribution density of the troughs and peaks, making it easier for tissue debris to slide off the troughs, thereby reducing the adhesion of the second blade 322. This feature improves surgical efficiency and reduces the frequency of intraoperative cleaning. (4) The wavy second blade 322 can optimize the cutting force distribution; the design of superimposed waveforms makes the cutting force distribution more uniform, avoiding the stress concentration problem caused by a single waveform. The combination of amplitude attenuation and waveform superposition achieves mechanical balance throughout the cutting process and reduces the risk of blade breakage or excessive deformation. (5) The wavy second blade 322 can adapt to complex blood vessel morphology; the asymmetry and dynamic changes of the waveform enhance the fit between the second blade 322 and the inner wall of the blood vessel, making it more adaptable to blood vessels with complex shapes such as bends and bifurcations, thereby improving the flexibility of clinical operations.

[0128] For further information, see Fig. 9 As a specific embodiment of the cutting balloon catheter provided by the present invention, a plane parallel to the blade is set as: the fourth projection plane; the projection of the predetermined straight line in the fourth projection plane is: the horizontal axis of the rectangular coordinate system in the fourth projection plane; the projection of the intersection of the edge of the first blade 321 and the edge of the second blade 322 on the fourth projection plane is the origin; the projection of the edge of the second blade 322 on the fourth projection plane is: ; ;in, , , , , , , , , , are respectively a value greater than zero (in one embodiment, In one embodiment, , are respectively between 0.1 and 1. In one embodiment, , are respectively between 1 and 5. In one embodiment, are respectively between 0.1 and 5. In one embodiment, are respectively between 0.01 and 1. In one embodiment, are respectively between 0.1 and 0.5. In one embodiment, They are between 0.1 and 1 respectively. Avoid excessive fluctuations. );

[0129] Fourth projection plane: a plane parallel to the blade; a coordinate system is provided in the fourth projection plane; the horizontal axis of the coordinate system in the fourth projection plane is: the projection of the predetermined straight line in the fourth projection plane; the origin of the coordinate system in the fourth projection plane is: the projection of the intersection of the edge of the first blade 321 and the edge of the second blade 322 on the fourth projection plane;

[0130] , is: the projection of the edge of the second blade 322 on the fourth projection plane ( is: two sine functions superimposed and modulated by a cosine function);

[0131] : The total length of the projection of the edge of the second blade portion 322 on the fourth projection plane;

[0132] For: The first wave (where the first wave: ) represents the amplitude of the first waveform, which defines the height of the first waveform, that is, half the distance between the peak and the trough;

[0133] is: represents the wavelength of the first waveform, that is, the horizontal distance between adjacent peaks or troughs;

[0134] For: The second wave (among which, the second wave: ) represents the amplitude of the second waveform, which defines the height of the second waveform, that is, half the distance between the peak and the trough;

[0135] is: represents the wavelength of the second waveform, that is, the horizontal distance between adjacent peaks or troughs;

[0136] : Introducing square into the second term increases the nonlinear characteristics of the waveform;

[0137] is: modulation intensity; modulation wave (wherein, modulation wave: ); represents the amplitude of the modulating waveform, which defines the height of the modulating waveform, that is, half the distance between the peak and the trough;

[0138] is: represents the wavelength of the modulated waveform, that is, the horizontal distance between adjacent peaks or troughs;

[0139] : Amplitude attenuation term, reducing the violent fluctuation at the tail end of the waveform;

[0140] : represents the peak characteristic, which is used to introduce local enhancement at the origin;

[0141] : Control the peak intensity; that is, control Height;

[0142] : controls the peak width; larger Make the peak more concentrated and steeper, suitable for precise positioning cutting;

[0143] Thus, (1) the wavy second blade portion 322 can enhance the precision cutting with a local peak; Increasing the cutting depth at a specific location of the second blade 322 can provide greater cutting force in critical areas. This design is very suitable for precise treatment of hard plaques or fibrotic tissues, while the waveform in other areas maintains flexible cutting to protect healthy tissues. (2) The wavy second blade 322 can be modulated at multiple frequencies to improve cutting efficiency; the modulation item The dynamic amplitude change is introduced to make the waveform have short-term strength enhancement and attenuation characteristics. Such changes increase the friction dynamics between the cutting edge and the tissue, reduce cutting resistance, and improve efficiency. (3) The wavy second blade 322 can reduce the stress concentration at the end; the amplitude attenuation term The waveform at the end of the second blade 322 is smoothed, which reduces the damage to the tissue and stress concentration at the end, and improves the safety of the blade, especially in high-pressure expansion. (4) The wavy second blade 322 has a nonlinear waveform that adapts to complex shapes; The nonlinear characteristics of the waveform show highly adjustable cutting performance at different positions, which is suitable for complex vascular areas such as bends and bifurcations. High-order nonlinearity enhances the adaptability to different lesion depths. (5) The wavy second blade 322 can optimize the processing of cutting debris; the combination design of the multi-frequency waveform forms more troughs and peaks, making it easier for the debris generated by tissue cutting to slide off the second blade 322, further reducing the accumulation of attachments on the surface of the second blade 322 and reducing the frequency of cleaning during surgery. (6) The wavy second blade 322 can improve the durability of the blade; through the design of modulation and spikes, the blade is more dispersed, avoiding breakage or deformation caused by excessive stress at a single point, and extending the service life of the blade. This feature is particularly important in dealing with hard lesions or repeated use.

[0144] For further information, see Figures 1 to 5 As a specific embodiment of the cutting balloon catheter provided by the present invention, a recessed portion with an annular edge is provided on the outer wall of the blade outside the blade 32.

[0145] For further information, see Figures 1 to 5As a specific embodiment of the cutting balloon catheter provided by the present invention, the inner wall of the recessed portion is wavy.

[0146] For further information, see Figures 1 to 5 As a specific embodiment of the cutting balloon catheter provided by the present invention, a plane parallel to the blade is set as: the fifth projection plane; the projection of the predetermined straight line in the fifth projection plane is: the first reference line; the center of the projection of the recessed portion on the fifth projection plane is the origin; the straight line passing through the origin and parallel to the first reference line is the horizontal axis of the rectangular coordinate system in the fifth projection plane; the three-dimensional distribution of the inner wall of the recessed portion is: ; ;in, , , , , are respectively a value greater than zero (in one embodiment, In one embodiment, are respectively between 0.1 and 1. In one embodiment, , are respectively between 0.5 and 5. In one embodiment, Between 0.05 and 0.5. Avoid excessive fluctuations. );

[0147] :Indicates that the concave part is perpendicular to the fifth projection plane The three-dimensional height value in the axial direction; this function describes the shape of the wave-like depression and defines its height variation at different positions;

[0148] ( , ): represents the coordinates of the depressed portion in the fifth projection plane;

[0149] : Fluctuation (fluctuation: )’s amplitude, controlling the height of the fluctuation;

[0150] : wavelength coefficient, respectively controlled wavelength in direction;

[0151] : wavelength coefficient, respectively controlled wavelength in direction;

[0152] : Attenuation coefficient, used to control The decay rate of the wave pattern determines the gradual and smooth transition of the wave pattern;

[0153] : radius of the concave part; defines the range of action of the waveform and controls the concave part within the effective area;

[0154] In this way, (1) the biocompatibility and safety of the blade are improved; this wavy recessed portion design that is not used for cutting provides a flexible area on the outer side of the blade, which helps to reduce direct contact between the blade and the surrounding vascular tissue. This can effectively avoid accidental damage caused by the hard edge of the outer side of the blade, especially when contacting healthy tissue, avoiding unnecessary mechanical damage and excessive stimulation, and helping to reduce complications during surgery. (2) Enhanced fluid dynamics effect; the wavy recessed portion can not only optimize the mechanical properties of the blade, but also enhance the fluid dynamics effect. The wavy shape of the inner wall of the recessed portion provides a larger surface area, which can help better guide and flow blood or other body fluids during surgery, thereby reducing the problem of poor blood flow in the surgical area and enhancing operational stability during surgery. In addition, the wavy recessed design can also slow down the flow rate of the liquid and help improve the hemostasis effect during surgery. (3) Optimize mechanical transmission and stress distribution; the wavy design of the recessed portion optimizes the overall stress distribution of the blade through the action of nonlinear mechanics. In the recessed portion of the blade, the height and width of the waveform increase with , The coordinates change, so the stress in the cutting area is no longer concentrated in a fixed area, but is relieved through the distribution of the wave shape. This effectively reduces the cracks or fatigue problems that may occur in the blade during operation and increases the service life of the blade. (4) Reduce debris accumulation and cleaning difficulty: The wavy concave inner wall provides a self-cleaning function for the blade. Compared with traditional blades, the concave shape can reduce the accumulation of tissue debris. Blood and other debris are more likely to slide down under the guidance of the wavy inner wall, reducing the possibility of debris adhering to the blade surface, thereby improving the cleaning performance of the blade, reducing the frequency of intraoperative cleaning, and ensuring the continuity and efficiency of the cutting process. (5) Adapt to different forms of tissue structures: The design of the wavy concave part enables the blade to adapt to the morphology of different blood vessels or tissues. Its asymmetric waveform can be adaptively adjusted according to the curvature or complex structure of the blood vessel, so that the blade can better fit the inner wall of the blood vessel, avoiding severe friction between the blade and the inner wall of the blood vessel, reducing instability and deviation during operation, and enhancing the accuracy of the surgery. (6) Improve the mechanical strength and durability of the blade; the wavy concave shape helps to evenly disperse the external force on the blade by forming a curved surface structure on the outside of the blade. Compared with a smooth blade surface, this structure can effectively reduce stress concentration, improve the blade's fatigue resistance, and extend the blade's service life, especially in high-frequency operations to maintain its original cutting accuracy.

[0155] For further information, see Figures 1 to 5As a specific embodiment of the cutting balloon catheter provided by the present invention, a plane parallel to the blade is set as: the sixth projection plane; the projection of the predetermined straight line in the sixth projection plane is: the second reference line; the center of the projection of the recessed portion on the sixth projection plane is the origin; the straight line passing through the origin and parallel to the second reference line is the horizontal axis of the rectangular coordinate system in the sixth projection plane; the three-dimensional distribution of the inner wall of the recessed portion is: ; ;in, , , , , , , , , , , are respectively a value greater than zero (in one embodiment, In one embodiment, , , , are respectively between 0.1 and 1. In one embodiment, , are respectively between 1 and 10. In one embodiment, , , are respectively between 0.1 and 2. In one embodiment, Between 0.01 and 1. Avoid excessive fluctuations. );

[0156] : Indicates that the inner wall of the concave portion is perpendicular to the sixth projection plane The three-dimensional height value in the axial direction; this function describes the shape of the wave-like depression and defines its height variation at different positions;

[0157] ( , ): represents the coordinates of the depressed portion in the sixth projection plane;

[0158] : The first wave (the first wave: ) controls the amplitude of the first wave, which is half the maximum distance between the peak and the trough;

[0159] : The second wave (The second wave: )’s amplitude; controls the height of the second wave;

[0160] : The third wave (The third wave: ) amplitude; controls the height of the third wave; this item introduces nonlinear wave characteristics;

[0161] : The fourth wave (the fourth wave: ) amplitude; controls the height of the fourth wave; this term and Introducing fluctuations in the interaction of directions;

[0162] : The number of the first wave; affects the first wave in Frequency of fluctuations in direction;

[0163] : The wave number of the second wave; affects the second wave in Frequency of fluctuations in direction;

[0164] : The number of the third wave; the influence of the third wave in Frequency of fluctuations in direction;

[0165] : The number of the third wave; the influence of the third wave in Frequency of fluctuations in direction;

[0166] : The wave number of the fourth wave; affects the fourth wave in and Frequency of fluctuations in direction;

[0167] : Attenuation coefficient, used to control The decay rate of the wave pattern determines the gradual and smooth transition of the wave pattern;

[0168] : radius of the concave part; defines the range of action of the waveform and controls the concave part within the effective area;

[0169] Thus, (1) the enhanced complex wave shape; this function introduces more combinations of sine and cosine functions, especially high-order sine terms (such as and ), so that the wave shape of the concave part is no longer simple and single, but has more changes and irregularities. The high-order fluctuation makes the concave part present a more multi-dimensional and complex waveform in space, thereby enhancing the contact stability of the blade and avoiding excessive friction or unbalanced cutting caused by surface smoothness. (2) Optimized distribution of local stress: Due to the complexity of the wave shape, each area of ​​the concave part is subjected to different forces in the ever-changing wave depth. This multi-level fluctuation helps to evenly distribute the contact force between the blade and the tissue, avoiding damage or breakage of the blade edge due to stress concentration. During surgery, this design improves the durability and stability of the blade, especially when used frequently, the service life of the blade is significantly improved. (3) Adaptive cutting and non-contact protection: The concave part with a complex wave shape can promote changes in the tissue microenvironment around the blade through tiny oscillations and fluctuations without contacting the inner wall of the blood vessel. The change of the wave helps to enhance the contact effect between the blade and the blood vessel, thereby avoiding excessive invasion of the blade and reducing damage to the inner wall of the blood vessel. This non-cutting wave shape design helps to provide better protection, especially when performing delicate operations, which can effectively reduce accidental damage to the blood vessel wall. (4) Improved self-cleaning effect: More complex wave shapes provide more surface textures, thereby increasing the contact area between the blade surface and blood or cutting debris. As the wave shape rises and falls, liquid and debris are easier to slide and flow on the blade surface, reducing the accumulation of debris and helping the blade to remain clean for a longer time. This not only reduces the frequency of intraoperative cleaning, but also reduces the risk of debris accumulation affecting cutting efficiency. (5) Enhanced fluid dynamics effect: The wavy concave part provides a more efficient guiding effect on the flow of fluid due to its variable depth and curved surface structure. Especially in the case of blood flow, the wave shape on the blade surface can guide the direction of blood flow, optimize intraoperative blood flow control, and reduce the risk of postoperative blood accumulation or thrombosis. In addition, the wavy area increases the contact area of ​​the liquid, further contributing to the intraoperative hemostasis effect. (6) Flexible adaptation to different tissues: This complex wave shape design can adapt to different tissue and blood vessel morphologies. During the operation, the wave shape of the blade can be adaptively adjusted according to different anatomical structures, allowing the blade to flexibly cope with various curved and irregular shaped blood vessels. This improves the accuracy and stability of surgical operations, especially in narrow or tortuous blood vessel areas, ensuring uniform and stable cutting effects.

[0170] For further information, see Figures 1 to 5 As a specific embodiment of the cutting balloon catheter provided by the present invention, a T-shaped hollow hole 17 is provided on the blade;

[0171] For further information, see Figures 1 to 5As a specific embodiment of the cutting balloon catheter provided by the present invention, the corners of the T-shaped hollow hole 17 are smoothly connected.

[0172] In one embodiment, a plane parallel to the blade is set as the seventh projection plane; the projection of the predetermined straight line in the seventh projection plane is the horizontal axis of the rectangular coordinate system in the seventh projection plane; the three-dimensional distribution of the T-shaped hollow holes 17 is: ; It is the reference center point of the T-shaped hole; and They are: step function; among them,

[0173] , , are respectively a value greater than zero (in one embodiment, , are respectively between 1 and 5. In one embodiment, They are between 0.1 and 2 respectively. );

[0174] : represents the T-shaped hollow hole 17 perpendicular to the seventh projection plane The three-dimensional height value in the axis direction;

[0175] ( , ): represents the coordinates of the T-shaped hollow hole 17 in the seventh projection plane;

[0176] ( , ): the center coordinate of the T-shaped hollow hole 17, defining the intersection of the vertical part and the horizontal part;

[0177] : respectively represent the width of the vertical part of the T-shaped hollow hole 17;

[0178] : represent the width of the horizontal part of the T-shaped hollow hole 17 respectively;

[0179] : A step function of the vertical portion; used to define the shape area of ​​the vertical portion of the T-shaped hollow hole 17, ensuring that the vertical portion of the hole forms a complete contour within a set range;

[0180] : A step function of the horizontal portion; used to define the shape area of ​​the horizontal portion of the T-shaped hollow hole 17, ensuring that the horizontal portion of the hole forms a complete contour within the set range;

[0181] : Exponential decay factor, control The decay rate of the hole shape is controlled to avoid sharp angles and irregular edges.

[0182] : This item is used to control the gradual effect of the hole, so that the edge of the hole gradually expands from the center to the outer edge, forming a smooth transition area and avoiding unnatural sharp edges;

[0183] Thus, (1) the T-shaped hollow hole 17 can optimize the lightweight design of the blade; the T-shaped hollow hole design optimizes the weight and mechanical strength of the blade by removing part of the material of the blade. Since the hole area is a local removal of material, the overall weight of the blade is effectively reduced while maintaining sufficient strength. This has significant advantages for fatigue strength during long-term use, especially in medical devices that require long-term operation, which can reduce the burden on the operator and improve comfort. (2) The T-shaped hollow hole 17 can improve fluid dynamics performance; the hollow T-shaped hole not only reduces the use of materials, but also improves the fluid dynamics of the blade surface. In particular, in vascular surgery, the T-shaped hole can help optimize fluid flow, especially blood. The structure of the hole can guide blood flow, reduce fluid retention, improve blood fluidity and cleaning effect, reduce the risk of blood accumulation during surgery, enhance hemostasis effect, and ensure smooth operation. (3) The T-shaped hollow hole 17 can enhance the cutting stability of the blade; the T-shaped hollow hole forms an irregular edge on the blade surface, so that the blade can better control the pressure distribution when contacting blood vessels or tissues. Due to the presence of the hole, the contact area of ​​the blade is reduced and the pressure concentration effect is reduced. Therefore, the blade can transmit force more evenly during the cutting process, avoiding uneven damage to the surrounding tissue. Especially when processing soft tissue, the T-shaped hole design helps to improve the stability and accuracy of cutting. (4) The T-shaped hollow hole 17 can reduce debris accumulation and self-cleaning function; the hollow structure of the T-shaped hole design also has the advantage of reducing debris accumulation. During surgery, tissue debris and blood tend to adhere to the surface of the blade, and the T-shaped hole can effectively guide the debris to be discharged and reduce their residence on the blade surface. Through this design, the blade surface remains clean for a longer time, reducing the frequency of intraoperative cleaning and improving the continuous cutting performance and use efficiency of the blade. (5) Enhance the mechanical strength and durability of the blade; although the T-shaped hollow hole removes a part of the material, it can actually enhance the overall mechanical strength of the blade through clever design. The presence of the hole enables the blade to distribute stress more evenly when shearing or under force, avoiding excessively concentrated mechanical damage or fatigue failure. In addition, the edge of the hole is designed with an exponential decay function, which makes the edge transition smooth, reduces the stress concentration caused by the sharp edge, and thus enhances the durability of the blade. (6) Adapt to a variety of surgical scenarios; the T-shaped hole design has good adaptability and is particularly suitable for complex vascular or soft tissue surgery. Its structure helps the blade provide more precise control when facing different tissue morphologies. In narrow blood vessels, the T-shaped hole can effectively reduce the friction between the blade and the inner wall of the blood vessel and avoid excessive compression of the blood vessel. In addition, the shape of the hole can be adjusted according to specific surgical needs, making it more flexible and changeable.

[0184] In one embodiment, a step function (Heaviside function) is briefly described as follows: In mathematics, a step function (Heaviside function) is a very common piecewise function, which is usually used to define functions whose values ​​are zero or one in a specific region. The step function is used to control the switching between different regions, so that a function has one value in some regions and another value in other regions.

[0185] Step function definition:

[0186]

[0187] In one embodiment,

[0188]

[0189] here, is the center of the vertical part, is the width of the vertical part. When the step function The value of is 1, indicating that the area is part of the T-shaped hole; When , the value is 0, indicating that the area is the solid part of the blade.

[0190] In one embodiment, a plane parallel to the blade is set as: the eighth projection plane; the projection of the predetermined straight line in the eighth projection plane is: the horizontal axis of the rectangular coordinate system in the eighth projection plane; the three-dimensional distribution of the T-shaped hollow holes 17 is: ; It is the reference center point of the T-shaped hole; and They are: step function; among them,

[0191] , , , , are respectively a value greater than zero (in one embodiment, , are respectively between 1 and 5. In one embodiment, is between 0.1 and 2. In one embodiment, , They are between 0.1 and 1 respectively. );

[0192] : represents the T-shaped hollow hole 17 perpendicular to the eighth projection plane The three-dimensional height value in the axial direction; this function describes the shape of the T-shaped hollow hole 17;

[0193] ( , ): represents the coordinates of the T-shaped hollow hole 17 in the seventh projection plane;

[0194] ( , ): the center coordinate of the T-shaped hollow hole 17, defining the intersection of the vertical part and the horizontal part;

[0195] : A step function of the vertical portion; used to define the shape area of ​​the vertical portion of the T-shaped hollow hole 17, ensuring that the vertical portion of the hole forms a complete contour within a set range;

[0196] : A step function of the horizontal portion; used to define the shape area of ​​the horizontal portion of the T-shaped hollow hole 17, ensuring that the horizontal portion of the hole forms a complete contour within the set range;

[0197] : respectively represent the width of the vertical part of the T-shaped hollow hole 17;

[0198] : represent the width of the horizontal part of the T-shaped hollow hole 17 respectively;

[0199] , : The sine and cosine functions are introduced to further shape the edge of the hole, so that the shape of the hole is not only rectangular, but also adds slight fluctuations or curvature changes to ensure that the edge of the hole is smoother and has a gradual characteristic;

[0200] :control The frequency in the hole affects the vertical edge wave characteristics;

[0201] :control The frequency in affects the horizontal edge fluctuation characteristics of the hole;

[0202] : Exponential decay factor, control The decay rate of the exponential decay is controlled to ensure that there are no sharp edges in the transition part of the hole and to ensure a smooth transition of the structure.

[0203] Thus, (1) the T-shaped hollow hole 17 can have a smoother hole edge; by adding and With such sine and cosine functions, the edge of the hole of the blade has a significant smoothing effect. These wave functions can create tiny curve fluctuations, making the contour edge of the hole transition from a sharp straight line to a smooth arc. This smooth transition is very important for reducing stress concentration, avoiding the risk of blade breakage caused by excessive stress caused by traditional sharp edges. (2) The T-shaped hollow hole 17 can optimize the mechanical properties and fatigue strength; the added sine and cosine functions will make the hole edge more natural and reduce local stress concentration. This design not only improves the overall structural strength of the blade, but also allows the blade to have a longer service life in repeated operations. Under repeated stress, the fatigue strength of the blade is improved, reducing fatigue fracture or wear caused by excessive local stress. (3) The T-shaped hollow hole 17 can achieve higher fluid dynamics performance; by making the edge of the hole more curvature-varying, the blade surface can guide liquid (such as blood) to flow along different paths and reduce liquid retention. Combined with the exponential decay function, the blade surface can create a smoother transition area, reducing obstacles and irregular flow phenomena in fluid flow. This is crucial for controlling blood flow, especially during vascular surgery, as it can effectively reduce blood accumulation and retention, and improve the hemostasis effect during surgery. (4) The T-shaped hollow hole 17 can be highly customized and adaptable; by introducing sine and cosine functions, the blade hole shape can be customized within a wider range. Designers can flexibly adjust parameters according to different surgical needs. and , and then change the fluctuation amplitude, frequency and other characteristics of the hole. By adjusting these parameters, different forms of T-shaped holes can be obtained, which provides more flexibility for adapting to various surgical scenarios and needs. For example, in situations where delicate operations are required, the smoothness of the hole can be enhanced by reducing the fluctuation amplitude and frequency; while in large-area cutting, the cutting effect can be increased by increasing the fluctuation amplitude. (5) Improve structural and aesthetic effects; In addition to technical performance, the addition of the fluctuation design makes the T-shaped hollow hole not only more functional, but also adds some aesthetic effects in appearance. This wavy shape can not only reduce the mechanical risks brought by sharp edges, but also give the blade more design inspiration, making it more modern and technological in appearance. For medical devices, in addition to functional requirements, aesthetics is also an important consideration in design, especially in the market of high-end medical equipment. (6) T-shaped hollow hole 17 can accurately cut and protect tissue; the smoother and curvature-adjusted hole shape can better contact with tissue in actual use, and can control pressure distribution, reduce friction and uneven pressure between the blade and tissue, thereby enhancing the accuracy of blade cutting. At the same time, by avoiding excessive contact between the sharp edge and the blade body, damage to surrounding tissues can be reduced, especially in the cutting of soft tissues, which can provide higher protection and control.

[0204] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and substitutions can be made without departing from the technical principles of the present invention. These improvements and substitutions should also be regarded as the scope of protection of the present invention.

Claims

1. A cutting balloon catheter, characterized in that: include: tube body; The tube body comprises: a proximal end and a distal end; A balloon; the balloon is arranged on the tube body between the proximal end and the distal end; A delivery channel; the delivery channel is used to deliver the medium injected into the balloon; the delivery channel is arranged in the tube body, and one end of the delivery channel is connected to the balloon; and A cutter; the cutter is disposed on the outer surface of the balloon; The cutter is a blade; part of the blade edge is wavy; the blade is flat; the blade includes: a first blade portion and a second blade portion adjacent to the first blade portion; the edge of the first blade portion extends along a predetermined straight line, and the edge of the second blade portion is wavy; A recessed portion with an annular edge is arranged on the outer wall of the blade outside the blade; the inner wall of the recessed portion is wavy; the wavy shape of the inner wall of the recessed portion provides a larger surface area, which can guide and flow blood during surgery; the wavy shape of the recessed portion makes the stress of the cutting area of ​​the blade no longer concentrated in a fixed area through the effect of nonlinear mechanics; the concave shape of the recessed portion can reduce the accumulation of tissue debris; the wavy recessed portion enables the blade to adapt to the morphology of different blood vessels or tissues; The recessed portion is a flexible area on the outer side of the blade, which reduces the direct contact between the blade and the surrounding vascular tissue; the recessed portion is subjected to different stresses in the continuously changing wave depth.

2. The cutting balloon catheter according to claim 1, characterized in that: Also includes: A guidewire channel; the guidewire channel is arranged in the tube body; the balloon is wrapped around the outside of the guidewire channel.

3. The cutting balloon catheter according to claim 2, characterized in that: The tube body includes: an inner tube and an outer tube sleeved on the outer side of the inner tube; the lumen inside the inner tube forms the guide wire channel, the inner tube and the outer tube are spaced apart, and the delivery channel is formed between the inner tube and the outer tube; the balloon is wrapped around the outer side of the inner tube and / or the outer tube.

4. The cutting balloon catheter according to claim 3, characterized in that: Also includes: A developing ring; the developing ring is arranged on the inner tube inside the balloon.

5. The cutting balloon catheter according to claim 2, characterized in that: Also includes: A first catheter seat, a first stress relief tube and a metal tube; the first catheter seat is connected to the tube body through the first stress relief tube and the metal tube in sequence; The first catheter seat has a first injection port communicated with the delivery channel.

6. The cutting balloon catheter according to claim 2, characterized in that: Also includes: a second catheter seat and a second stress relief tube; the second catheter seat is connected to the tube body through the second stress relief tube; The second catheter seat has a second injection port communicated with the delivery channel, and the second catheter seat has an entry port communicated with the guidewire channel.

7. The cutting balloon catheter according to any one of claims 1 to 6, characterized in that: The cutter is fixed on the outer surface of the balloon.

8. The cutting balloon catheter according to claim 1, characterized in that: The blade is bonded to the outer surface of the balloon.

9. The cutting balloon catheter according to claim 1, characterized in that: Also includes: a base fixed on the surface of the balloon; The blade has an inserting portion which is inserted into the inserting hole on the base.

10. The cutting balloon catheter according to claim 9, characterized in that: The base is provided with a glue injection hole; the glue injection hole is communicated with the insertion hole, and the insertion part is glued in the insertion hole.

11. The cutting balloon catheter according to claim 9, characterized in that: The base has a U-shaped curved surface for being attached to and bonded to the balloon.

12. The cutting balloon catheter according to claim 1, characterized in that: The blade is U-shaped.

13. The cutting balloon catheter according to claim 12, characterized in that: One end of the U-shaped blade close to the balloon is connected with a reinforcing rib.

14. The cutting balloon catheter according to claim 13, characterized in that: The number of the reinforcing ribs is multiple.

15. The cutting balloon catheter according to claim 1, characterized in that: The balloon is ellipsoidal or spherical; the number of the blades is multiple; and the multiple blades are arranged on the balloon in a surrounding and spaced manner.

16. The cutting balloon catheter according to claim 15, characterized in that: The number of the blades is four.

17. The cutting balloon catheter according to claim 16, characterized in that: Two of the blades are located at opposite ends of the balloon, and the other two blades are located at opposite ends of the balloon.

18. The cutting balloon catheter according to claim 1, characterized in that: In the extension direction of the tube body, a plurality of rows of blades are arranged on the surface of the balloon, and each row of blades has two to six blades.

19. The cutting balloon catheter according to claim 1, characterized in that: The blade is made of one or more of stainless steel, nickel-titanium alloy, aluminum alloy, carbon steel, titanium alloy, and ceramic.

20. The cutting balloon catheter according to claim 1, characterized in that: The blade is provided with a T-shaped hollow hole.

21. The cutting balloon catheter according to claim 20, characterized in that: The corners of the T-shaped hollow holes are smoothly connected.

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