A balloon assembly and balloon catheter system with enhanced cutting effect

Abstract

A balloon catheter system includes a catheter, a buffer tube, and a balloon assembly with enhanced cutting effect, wherein the balloon assembly includes a balloon and a metal mesh wrapped around the outside of the balloon, wherein the metal mesh includes a connecting proximal end, a connecting distal end, and an action segment connected therebetween, wherein the connecting distal end is connected to the distal end of the balloon, wherein a plurality of auxiliary cutting elements are dispersedly arranged on the action segment, wherein the catheter passes through the buffer tube and is connected to the proximal end of the balloon, wherein the proximal end of the buffer tube is connected to the outside of the catheter, and the distal end of the buffer tube is connected to the connecting proximal end. The present invention can accurately locate in a blood vessel, can provide an expansion force far greater than that of a traditional structure, can effectively expand even a highly calcified lesion, improves drug utilization, reduces vascular damage, and reduces restenosis rate, and is worthy of promotion and use in this field.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, in particular to a balloon component and a balloon catheter system with enhanced cutting effect. Background Art

[0002] The invention of percutaneous transluminal angioplasty is a major breakthrough in the treatment of vascular diseases. After more than 20 years of development, balloon angioplasty has become a relatively mature technology recognized by the medical community. Balloon angioplasty is mainly used to revascularize stenotic and occluded blood vessels. By inserting a catheter with an expansion balloon into the vascular system, the balloon expands in the stenotic and occluded area of ​​the blood vessel under external pressure, so as to apply radial pressure to the inner wall of the blood vessel, widen the stenotic and occluded area, and improve blood flow.

[0003] Traditional balloon angioplasty mainly introduces a balloon into the diseased blood vessel, and then expands the balloon to open the diseased blood vessel, such as a vascular dilation balloon disclosed in the patent document with application number CN201320567219.0, which includes: a balloon body, an inner tube, a double-lumen catheter, an injection handle and a guide wire port, the inner tube is arranged inside the balloon body and passes through the balloon body, the inner tube is sleeved on the front end of the double-lumen catheter, and the injection handle is arranged at the rear end of the double-lumen catheter; the guide wire port is arranged on the side wall of the front end of the double-lumen catheter, and the guide wire port divides the double-lumen catheter into two lumens, the two lumens are: a filling lumen and a guide wire lumen, the filling lumen is connected to the injection handle, and the guide wire lumen is connected to the inner tube.

[0004] However, conventional balloon angioplasty also has many other shortcomings. For example: (1) restenosis. In some cases, the balloon over-expansion during balloon catheter dilation may damage the blood vessel, which may cause the patient's blood vessel to stretch beyond its elastic limit, damage the blood vessel wall and cause restenosis in the area of ​​over-expansion balloon dilation; (2) elastic retraction of the blood vessel. Conventional balloons are difficult to treat fibrotic lesions, and elastic retraction of the dilated blood vessel can usually be observed after treating these lesions. Conventional balloons are also difficult to treat because long lesions have fibrotic lesions; (3) During the balloon pre-dilation process for the treatment of severe hard calcified lesions, due to the insufficient performance of the conventional balloon itself, the pressure applied by the balloon to the hard calcified part of the blood vessel is insufficient, and the blood vessel cannot be effectively dilated. The balloon is prone to form a "dog bone" phenomenon or the balloon slides during the dilation process, which may cause damage to the blood vessel wall around the treated lesion. If stent implantation is required immediately after balloon dilation, the failure of balloon angioplasty to properly widen the narrowed blood vessel may result in inaccurate positioning of the stent in the blood vessel. This inaccurate positioning may lead to a higher restenosis rate of the stent. If a drug-eluting stent is used, it will weaken the effectiveness of the drug-eluting stent.

[0005] In order to overcome some of the above problems, blade-type cutting balloons and single or multiple cutting wire cutting balloons have appeared in the prior art. Among them, the blade-type cutting balloon is a technology that adds a cutting blade to the balloon, and the cutting blade cuts the plaque tissue on the inner wall of the blood vessel while the balloon expands. As disclosed in the patent document with application number CN201320563684.7, a cutting balloon for treating intravascular thrombosis and calcification lesions includes a balloon and several rows of blades axially installed on the outer circumferential surface of the balloon, and a certain gap is spaced between two adjacent blades in each row of blades, and each blade is fixed to the balloon via a ferrule fixed on the outer circumferential surface of the balloon, and a certain gap is spaced between two adjacent ferrules in the axial direction of the balloon.

[0006] A single or multiple cutting wire cutting balloon is a technology that fixes the cutting wire on the balloon surface. When the balloon expands, the cutting wire is embedded in the plaque tissue on the inner wall of the blood vessel, which effectively fixes and tears the plaque tissue. For example, a cutting balloon disclosed in the patent document with application number CN201810478242.X includes: a balloon body; a cutting wire radially arranged along the outer surface of the balloon body; two ends of the cutting wire are respectively fixed to the two ends of the balloon body; and the cutting wire includes a folding structure.

[0007] Although there are significant advantages in using blade-type cutting balloons or cutting wire cutting balloons in many cases, there are still technical defects. Among them, the blade-type cutting balloon has the cutting blade glued to the balloon, which makes the balloon itself very hard, resulting in poor overall permeability of the balloon, limiting the ability of the balloon to enter curved or smaller blood vessels. In addition, the cutting blade outside the balloon may also affect the pressure relief of the balloon, making it more difficult to withdraw the cutting balloon from the blood vessel than a conventional balloon, and it is more likely to cause vascular damage during the withdrawal process, resulting in surgical complications that may lead to risks and may be life-threatening. Single or multiple cutting wire cutting balloons have cutting wires that are completely fixed at the proximal and distal ends of the balloon. During the balloon expansion process, the balloon is very likely to deform into a banana shape, resulting in uneven force on the lesion, and the cutting effect cannot achieve the expected effect. In addition, the pressure should be gradually increased during balloon expansion to prevent the cutting wires from being entangled due to excessive pressure increase. In addition, in the prior art, during the operation, the balloon can only be dilated by inferring the cutting position based on the position of the developing ring on the balloon catheter under X-ray. The position of the cutting blade or cutting wire cannot be determined, and the cutting situation of the blood vessel by the cutting blade or cutting wire cannot be determined, which may cause damage to normal blood vessels and insufficient or excessive cutting of diseased blood vessels.

[0008] In addition to the above, drug-coated balloons (DEBs) and drug-eluting stents (DES) inhibit vascular inflammatory reactions and endothelial cell proliferation through coated drugs such as paclitaxel or rapamycin, thereby reducing the probability of restenosis. Among them, drug-coated balloons (DEBs) are new balloons that have appeared in recent years. They spray coating drugs that inhibit cell proliferation on the balloon surface. When the balloon is expanded, the drug is quickly transferred from the balloon surface to the blood vessel wall to inhibit endothelial cell proliferation. For example, a drug-coated balloon catheter disclosed in the patent document with application number CN201720958767.4 includes a push catheter with a certain axial length, at least one drug-coated balloon located at the distal end of the push catheter, and a sheath movably sleeved on the outside of the drug-coated balloon. The sheath can move along the axial direction of the push catheter, and the drug-coated balloon is accommodated in the sheath before expansion. However, before the drug balloon expands the blood vessel, the lumen of the blood vessel needs to be completely opened. A simple drug balloon, like a conventional balloon, cannot effectively expand calcified or fibrotic blood vessels.

[0009] Drug-eluting stents (DES) also inhibit endothelial cell proliferation through the drugs in their coatings. For example, a drug-eluting stent disclosed in the patent document with application number CN201620231313.2 consists of a stent matrix and a drug coating coated on the inner surface of the stent matrix. The drug coating has a three-layer structure, which is a degradable polymer layer, a drug layer, and a degradable polymer layer, starting from the layer in contact with the stent matrix. However, the unevenness of drug release at the intersection of the stent struts and the stimulation of the carrier to the blood vessel wall after the drug is released will increase the restenosis rate of the stent. In addition, drug-eluting stents (DES) are not suitable for every patient. Patients implanted with DES stents need to maintain anticoagulant treatment for a long time to minimize the risk of late thrombosis. It is not recommended for people who cannot accept anticoagulant treatment or may need surgery.

[0010] The emerging angioplasty medium is to combine a balloon with a constrained stent wrapped outside the balloon, such as a cutting balloon disclosed in the patent document with application number CN201721473170.7, which includes an inner lumen, which passes through the balloon body, a cutting net wrapped around the outside of the balloon body, and both ends of the balloon body and the cutting net are fixed to the inner lumen by a pressing device; one end of the inner lumen is a pointed tip. However, the actual use of this solution has limited cutting effect, and it is still easy to cause the migration of thrombus or plaque, and the expansion effect of highly calcified lesions is poor, it is easy to cause unnecessary vascular damage, the incidence of restenosis is high, and the overall interventional treatment effect is poor. Summary of the invention

[0011] One of the technical objectives of the present invention is to provide a balloon assembly with enhanced cutting effect, so as to solve the problems in the prior art of inaccurate balloon positioning and limiting, limited cutting effect on blockages at the lesion site, and insufficient expansion force on blood vessels at the lesion site, resulting in poor interventional treatment effect.

[0012] The specific technical solution of the present invention is as follows: a balloon assembly with enhanced cutting effect, comprising a balloon and a metal mesh wrapped around the outside of the balloon, the metal mesh comprising a proximal end, a distal end and an action segment connected therebetween, the distal end being connected to the distal end of the balloon, and a plurality of auxiliary cutting elements being dispersed on the action segment.

[0013] In this solution, on the basis of the action section, an auxiliary cutting element is further provided to further optimize and enhance the cutting effect of the metal mesh, so that the balloon can be effectively expanded even for highly calcified lesions, making it easier for the drug to be fully absorbed, thereby improving the effect of interventional treatment and reducing the incidence of restenosis.

[0014] Preferably, the action section includes a plurality of connecting rods, the auxiliary cutting element is arranged on the connecting rods, the connecting proximal end and the connecting distal end are both circumferential windings with a sawtooth waveform, and the apex of the crest or trough on the circumferential winding is the connection point with the action section.

[0015] The connecting rod cooperates with the auxiliary cutting element thereon to cut the diseased part, and at the same time serves as a restraining tool during the expansion of the balloon, so that the balloon can expand the blood vessel controllably and evenly.

[0016] Preferably, the action section includes a plurality of transition connection parts and a plurality of segments separated by the transition connection parts, the segments include a plurality of connecting rods, the auxiliary cutting elements are arranged on the connecting rods, the connecting proximal end, the connecting distal end and the transition connection part are all circumferential windings with a sawtooth waveform, and the apex of the crest or trough on the circumferential winding is the connection point with the connecting rod.

[0017] The plurality of segments prevents a single connecting rod from being too long, and combined with the transition connection portion, the structural strength of the entire action section is improved. During the expansion of the balloon, the cutting effect is optimized while knotting and twisting are avoided.

[0018] Preferably, the length of the segment is 20-30 mm.

[0019] Preferably, the auxiliary cutting element has a wing portion extending to one side or both sides in the width direction of the connecting rod.

[0020] The wing part serves as the cutting body. During the expansion process of the metal mesh accompanied by rotation, the wing part is equivalent to acting as a cutting point to circumferentially cut the lesion, which can cut off the elasticity and fiber continuity of the lesion and reduce the migration of thrombus or plaque. Compared with the connecting rod, the cutting effect is further enhanced, so that the balloon in this scheme has a stronger expansion force than the traditional balloon, and can effectively expand and improve the release and absorption of drugs.

[0021] Preferably, the top surface of the wing portion is a straight surface or a curved surface with an upward or downward bend at the end.

[0022] The end of the top surface of the side wing part can play a stronger cutting effect and can more easily penetrate into the vessel wall of the lesion to perform circumcision.

[0023] Preferably, the bottom surface of the wing portion is a smooth or rounded surface.

[0024] This design ensures that there are no sharp spots on the bottom surface of the side wing part, and it is not easy to puncture and damage the surface of the balloon.

[0025] Preferably, the auxiliary cutting elements provided on any two of the connecting rods are staggered with each other in the circumferential direction of the action section.

[0026] This design ensures that when the metal mesh is in a collapsed state together with the balloon or when the metal mesh is expanding with the balloon (and undergoes irregular twisting), the auxiliary cutting elements will not interfere with each other in the circumferential direction, that is, they will not be hooked and tangled together.

[0027] Preferably, one of the auxiliary cutting elements is provided on each of the connecting rods.

[0028] On the basis of realizing the aforementioned design of staggering the auxiliary cutting elements in the circumferential direction, the manufacturing process is relatively simple, the manufacturing cost is low, and the structure is simplified.

[0029] Preferably, the auxiliary cutting element is integrally formed with the connecting rod; or the auxiliary cutting element is an independent component connected and fixed to the connecting rod.

[0030] Preferably, the auxiliary cutting element is provided with a docking portion 1, and the connecting rod is provided with a docking portion 2, and the docking portion 1 is matched with the docking portion 2 and is connected and fixed.

[0031] Preferably, the auxiliary cutting element is a light-proof element.

[0032] The auxiliary cutting element is opaque. During the expansion process of the balloon, combined with the use of contrast agents, the cutting depth of the connecting rod and the auxiliary cutting element can be effectively determined, the cutting process can be monitored in real time, excessive cutting can be avoided, damage to endothelial cells and blood vessels can be reduced, and the incidence of restenosis can be reduced.

[0033] Preferably, the connection points connecting the two ends of the connecting rod are staggered in the axial direction and are spiral in the circumferential direction.

[0034] The spiral arrangement of the connecting rod enables the action section to rotate relative to the blood vessel to a certain extent during the expansion of the balloon, so that the connecting rod and the auxiliary cutting element thereon can fully cut the vascular lesion.

[0035] Preferably, the metal mesh is 1-100 mm longer than the balloon.

[0036] The metal mesh can be completely wrapped outside the balloon without compressing the balloon too tightly, and expands softly and evenly along with the balloon.

[0037] Another technical purpose of the present invention is to provide a balloon catheter system to solve the problems existing in the prior art of inaccurate balloon positioning and limiting, limited cutting effect on blockages at the lesion site, and insufficient expansion force on blood vessels at the lesion site, resulting in poor interventional treatment effect.

[0038] The specific technical solution of the present invention is as follows: a balloon catheter system, comprising a catheter, a buffer tube and the balloon assembly as described above, wherein the catheter passes through the buffer tube and is connected to the proximal end of the balloon, the proximal end of the buffer tube is connected to the outside of the catheter, and the distal end of the buffer tube is connected to the proximal end.

[0039] The balloon assembly in this solution is provided with the action segment and the auxiliary cutting element thereon, so as to further optimize and enhance the cutting effect of the metal mesh, and enable the balloon to expand effectively even for highly calcified lesions, so that the drug can be more easily and fully absorbed, thereby improving the effect of interventional treatment and reducing the incidence of restenosis.

[0040] Preferably, the buffer tube is a plastic polymer material tube or a metal tube laser-engraved in a spiral or π shape.

[0041] The buffer tube may undergo a certain deformation in the axial direction to compensate for the axial shortening of the metal mesh structure of the balloon assembly during the expansion process.

[0042] Preferably, the buffer tube is a light-proof tube.

[0043] The balloon assembly and balloon catheter system of the present invention have the following advantages:

[0044] 1. The metal mesh is arranged on the outer surface of the drug-coated balloon, and the action section can help the balloon to lock in place at the vascular lesion section, thereby preventing the balloon from slipping during or after expansion like a traditional naked balloon, and achieving accurate positioning of the balloon, thereby avoiding damage to healthy blood vessels around the lesion;

[0045] 2. Accurate positioning and limiting of the balloon facilitates the release of the drug coating, avoids the release of drugs in non-lesioned segments of blood vessels, improves drug utilization, more effectively inhibits postoperative intimal hyperplasia, prevents restenosis of blood vessels, and improves treatment effects;

[0046] 3. The metal mesh expands in a circular pattern as the balloon expands, contacts the vascular lesion site first, and cuts the lesion site. At the same time, as the balloon expands evenly, it reduces expansion damage, reduces the occurrence of irregular tearing of the intima, and minimizes the damage to endothelial cells. Compared with blade-type cutting balloons or wire-type cutting balloons, the present invention can further optimize the plaque at the lesion site, greatly reduce the incidence of dissection and acute vascular occlusion, and reduce the implantation rate of remedial stents;

[0047] 4. The auxiliary cutting element protrudes laterally from the connecting rod, and cooperates with the connecting rod to further enhance the cutting effect. As the metal mesh expands and rotates, it can cut off the elasticity and fiber continuity of the lesion site, reduce the migration of thrombus or plaque, reduce the shear force and radial force during the balloon expansion process, and avoid unnecessary vascular damage. Compared with traditional balloons, the present invention can provide 15 to 25 times the expansion force, and can also effectively expand highly calcified lesions to ensure that the drug is fully released and absorbed. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] Figure 1 It is a schematic diagram of the overall structure of an embodiment of the present invention;

[0049] Figure 2 It is a structural schematic diagram of an embodiment of the present invention in which the action section is only composed of connecting rods;

[0050] Figure 3 It is a structural schematic diagram of an embodiment of the present invention in which the auxiliary cutting unit and the connecting rod are integrally formed;

[0051] Figure 4 It is a structural schematic diagram of an embodiment of the present invention in which the auxiliary cutting unit and the connecting rod are integrally formed;

[0052] Figure 5 It is a structural schematic diagram of an embodiment of the auxiliary cutting unit and the connecting rod assembled and connected according to the present invention;

[0053] Figure 6 It is a structural schematic diagram of an embodiment of the present invention in which the action section is composed of a connecting rod and a transition connection part;

[0054] Figure 7 Schematic diagram of the structure of a buffer tube in an embodiment of the present invention;

[0055] The names of the parts corresponding to the numbers in the figure are: 1-balloon, 2-metal mesh, 21-proximal connection, 22-distal connection, 23-action section, 231-connecting rod, 232-transition connection part, 3-auxiliary cutting element, 31-side wing part, 32-main part, 4-catheter, 5-buffer tube, a-docking part one, b-docking part two. DETAILED DESCRIPTION

[0056] The present invention will be further described below by means of specific embodiments in conjunction with the accompanying drawings:

[0057] See Figure 1 An embodiment of a balloon catheter system includes a balloon assembly with enhanced cutting effect, a catheter 4 and a buffer tube 5, the balloon assembly includes a balloon 1 and a metal mesh 2 wrapped around the outside of the balloon 1, the metal mesh 2 includes a connecting proximal end 21, a connecting distal end 22 and an action segment 23 connected therebetween, the connecting proximal end 21 and the connecting distal end 22 are both circumferential windings with a sawtooth waveform, the apex of the crest or trough in the circumferential winding is the connection point with the action segment 23, and a plurality of auxiliary cutting elements 3 are provided on the action segment 23; the catheter 4 passes through the buffer tube 5 and is connected to the proximal end of the balloon 1, the proximal end of the buffer tube 5 is connected to the outside of the catheter 4, and the distal end of the buffer tube 5 is connected to the connecting proximal end 21.

[0058] The surface of the balloon 1 is coated with drugs, specifically paclitaxel, rapamycin and other anti-intimal hyperplasia drugs. The metal mesh 2 is made of a material with shape memory function by engraving or weaving. The more common production method is to use a laser to cut the nickel-titanium alloy tube into shape or to weave the nickel-titanium alloy wire into shape. The length of the metal mesh 2 is 50mm greater than the length of the balloon 1. The distal end of the buffer tube 5 is connected to the connection proximal end 21, and the distal end of the balloon 1 is connected to the connection distal end 22, and both can be connected and fixed by laser welding, hot melting, bonding and other connection methods. The buffer tube 5 is a plastic polymer material tube, or a metal tube engraved by a spiral or π-shaped laser, with a certain axial deformability, and a variable length range of about 1~15mm, to compensate for the axial shortening of the metal mesh during the expansion process, such as Figure 7 As shown; in addition, the buffer tube 5 has X-ray opaque properties for positioning tracking, and can be selected on the basis of the aforementioned materials and also have X-ray opaque properties, or can be added with X-ray opaque metal or plastic materials.

[0059] In some embodiments, Figure 2As shown, the action section 23 includes a plurality of independent connecting rods 231, and the auxiliary cutting element 3 is arranged on the connecting rod 231, and the connecting points in the connecting proximal end 21 and the connecting distal end 22 are correspondingly connected to the ends of the connecting rod 231. The connecting points at both ends of the connecting rod 231 are staggered in the axial direction and are spiral in the circumferential direction.

[0060] For further information, see Figure 3 or Figure 4 or Figure 5 , the auxiliary cutting element 3 extends to both sides of the width direction of the connecting rod 231 to form a wing portion 31 relative to the connecting rod 231. The wing portion 31 can perform additional circumferential cutting on the lesion during the expansion process of the metal mesh 2 accompanied by rotation, cut off the elasticity and fiber continuity of the lesion, reduce the migration of thrombus or plaque, reduce the shear force and radial force during the expansion process of the balloon 1, strengthen the cutting effect, provide 15 to 25 times the expansion force of the traditional balloon, and effectively expand even the highly calcified lesions to promote the full release and absorption of drugs.

[0061] The bottom surface of the wing portion 31 is a smooth or rounded surface. Figure 3 , Figure 4 , Figure 5 This is the case in the embodiment, in order to ensure that the bottom surface of the wing portion 31 does not puncture the surface of the balloon 1. Figure 3 , Figure 4 The bottom surface of the middle wing portion 31 is also concave inwards to further avoid excessive compression or puncture of the balloon 1. The top surface of the wing portion 31 can be freely set and can be a flat surface or a curved surface. Figure 3 , Figure 4 The top surface of the middle wing portion 31 and the top surface of the connecting rod 231 are on the same straight-grained surface. Due to the manufacturing process of the metal mesh 2, the outer surface of the connecting rod 231 is generally a straight-grained surface such as the side of a cylinder. The wing portion 31 is arranged in this way, which is equivalent to an integral extension of the top surface of the connecting rod 231, and the overall consistency is better. If the auxiliary cutting element 3 and the connecting rod 231 are integrally formed, the manufacturing and processing difficulty is relatively low. Such a wing portion 31 is smoother and softer when cutting, and has less stimulation to the blood vessels. Figure 5 The top surface of the middle wing portion 31 is a curved surface with the end portion tilted outward, which can further enhance the cutting effect on the lesion site, and the cutting depth of the lesion site will also be deeper, which can relatively more effectively cut off the elasticity and fiber continuity of the lesion site, and relatively more significantly reduce the shear force and radial force during the balloon expansion process, so that the balloon 1 has a stronger expansion ability for the blood vessels.

[0062] Furthermore, the auxiliary cutting elements 3 provided on any two connecting rods 231 are staggered in the circumferential direction of the action section 23 to prevent a plurality of auxiliary cutting elements 3 from interfering with each other and “fighting” on the same circumferential path. Figure 2 (as well as Figure 6 ), an auxiliary cutting element 3 is arranged on each connecting rod 231, and the auxiliary cutting element 3 arranged in this way is equivalent to being arranged spirally on the action section 23, and the auxiliary cutting elements 3 on different connecting rods 231 are staggered with each other, taking into account the aforementioned effect of avoiding interference and lower arrangement complexity and cost. Of course, arranging more auxiliary cutting elements 3 on each connecting rod 231 can increase the cutting effect on the blood vessels at the lesion site, or in the case of more connecting rods 231, the auxiliary cutting elements 3 can also have more cutting coverage areas in the axial direction, that is, there are more cutting places for the blood vessels at the lesion site in the axial direction.

[0063] There are two ways to form and connect the auxiliary cutting element 3. One way is to form the auxiliary cutting element 3 and the connecting rod 231 as one piece. For example, when the metal mesh 2 is laser cut, the connecting rod 231 and the auxiliary cutting element 3 are directly processed at the same time. Figure 3 , Figure 4 The auxiliary cutting element 3 can also be an independently manufactured individual. Figure 5 As shown, a docking portion a is provided on the main body portion 32 located between the two wing portions 31, and a docking portion b is provided on the connecting rod 231. The docking portion a and the docking portion b cooperate with each other and are fixedly connected. Here, the docking portion a and the docking portion b are matching docking grooves (they can also be two fitting docking surfaces, or the docking portion a is a section without a groove and the docking portion b is a groove, or in the form of plug-in holes and columns, grooves and blocks, etc.), connected by laser welding, hot melting, bonding or mechanical fixing (such as ferrules, buckles), etc., and the slotting combination makes the auxiliary cutting element 3 not protrude excessively longitudinally from the connecting rod 231, that is, its top surface will not be too high above the top surface of the connecting rod 231, and the overall consistency of the two after connection is better, and the blood vessels will not be excessively compressed or cut after expansion. In fact, Figure 3 , Figure 4 The implementation form can also be considered as the auxiliary cutting element 3 including two side wing parts 31 as independent elements, and the end faces of the side wing parts 31 are connected to the side faces of the connecting rod 231 by laser welding, hot melting, bonding or mechanical fixing.

[0064] The auxiliary cutting element 3 can be further made into an X-ray opaque element, such as completely made of X-ray opaque metal or plastic, or added with X-ray opaque metal or plastic during manufacturing. Compared with the light-opaque auxiliary cutting element 3, the effect achieved is better. It can be combined with contrast agents to effectively determine the cutting depth of the connecting rod 231 and the auxiliary element 3 during interventional treatment, try to monitor the cutting process, avoid over-cutting, reduce damage to endothelial cells and blood vessels, and reduce the incidence of restenosis.

[0065] In some other embodiments, the action section 23 includes a plurality of transition connection parts 232 and a plurality of segments separated by the transition connection parts 232. Generally, a transition connection part is provided for every segment of 20 to 30 mm. The segment includes a plurality of connecting rods 231. The auxiliary cutting element 3 is provided on the connecting rod 231. The transition connection part 232 is also a sawtooth waveform circumferential winding. The vertices of the crests or troughs on both sides of the circumferential winding are the connection points with the connecting rod 231. The connection points among the transition connection part 232, the proximal end 21, and the distal end 22 are connected to the corresponding ends of the connecting rod 231. Figure 6 An example of a transition connection part 232 and two segments is given. The length of the segment is selected to be relatively appropriate at 25mm (the range is 20mm~30mm). This is because when the segment is too long, that is, the single connecting rod 231 is too long, the structural strength will be reduced, and the connecting rods 231 will also "fight" with each other due to torsion interference during the expansion process. The connecting rods 231 at different axial locations will have a large difference in the expansion of the balloon 1, and cannot be expanded normally, and may even be entangled and twisted together. The transition connection part 232 ensures that the entire action section can expand normally.

[0066] It should be understood by those skilled in the art that the embodiments of the present invention described above and shown in the accompanying drawings are only examples and do not limit the present invention. The purpose of the present invention has been fully and effectively achieved. The functional and structural principles of the present invention have been demonstrated and explained in the embodiments, and the embodiments of the present invention may be deformed or modified in any way without departing from the principles.

Claims

1. A balloon assembly for enhancing cutting effect, comprising a balloon (1) and a metal mesh (2) wrapped around the outside of the balloon (1), the metal mesh (2) comprising a connecting proximal end (21), a connecting distal end (22) and an action section (23) connected therebetween, the connecting distal end (22) being connected to the distal end of the balloon (1), characterized in that: A plurality of auxiliary cutting elements (3) are dispersedly arranged on the action section (23); The action section (23) comprises a plurality of transition connection parts (232) and a plurality of segments separated by the transition connection parts (232), the segments comprise a plurality of connecting rods (231), the auxiliary cutting element (3) is arranged on the connecting rod (231), the connecting proximal end (21), the connecting distal end (22), and the transition connection part (232) are a circumferential winding with a sawtooth waveform, and the apex of the wave crest or wave trough on the circumferential winding is the connection point with the connecting rod (231); The metal mesh (2) is 1 to 100 mm longer than the balloon (1).

2. A balloon assembly for enhancing cutting effect according to claim 1, characterized in that: The length of the segment is 20-30 mm.

3. A balloon assembly for enhancing cutting effect according to claim 1, characterized in that: The auxiliary cutting element (3) has a wing portion (31) extending toward one side or both sides in the width direction of the connecting rod (231).

4. A balloon assembly for enhancing cutting effect according to claim 3, characterized in that: The top surface of the wing portion (31) is a flat surface or a curved surface with an end portion that is bent upward or downward.

5. The balloon assembly for enhancing cutting effect according to claim 3, characterized in that: The bottom surface of the wing portion (31) is a smooth or rounded surface.

6. The balloon assembly for enhancing cutting effect according to claim 3, characterized in that: The auxiliary cutting elements (3) arranged on any two of the connecting rods (231) are staggered with respect to each other in the circumferential direction of the action section (23).

7. A balloon assembly for enhancing cutting effect according to claim 6, characterized in that: Each of the connecting rods (231) is provided with an auxiliary cutting element (3).

8. The balloon assembly for enhancing cutting effect according to claim 3, characterized in that: The auxiliary cutting element (3) and the connecting rod (231) are integrally formed; or the auxiliary cutting element (3) is an independent element that is connected and fixed to the connecting rod (231).

9. A balloon assembly for enhancing cutting effect according to claim 8, characterized in that: The auxiliary cutting element (3) is provided with a docking portion 1 (a), and the connecting rod (231) is provided with a docking portion 2 (b), and the docking portion 1 (a) is matched with the docking portion 2 (b) and connected and fixed.

10. The balloon assembly for enhancing cutting effect according to claim 1, characterized in that: The connection points at the two ends of the connection rod (231) are staggered in the axial direction and are spiral in the circumferential direction.

11. A balloon catheter system, comprising a catheter (4), characterized in that: It also comprises a buffer tube (5) and a balloon assembly according to any one of claims 1 to 10, wherein the catheter (4) passes through the buffer tube (5) and is connected to the proximal end of the balloon (1), the proximal end of the buffer tube (5) is connected to the outside of the catheter (4), and the distal end of the buffer tube (5) is connected to the connecting proximal end (21).

12. A balloon catheter system according to claim 11, characterized in that: The buffer tube (5) is a plastic polymer material tube or a metal tube laser-engraved in a spiral shape or a π shape.

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