CN111528986A - Cutting-reinforced balloon assembly and balloon catheter system - Google Patents

Abstract

The utility model provides a sacculus pipe system, includes pipe, buffer tube and the sacculus subassembly of reinforceing the cutting effect, the sacculus subassembly includes the sacculus and wraps up the outside metal mesh of sacculus, the metal mesh is including connecting the near-end, connecting the far-end and connecting the effect section between the two, connect the far-end with the far-end of sacculus is connected, the dispersion is equipped with a plurality of supplementary cutting elements on the effect section, the pipe passes the buffer tube and with the near-end of sacculus is connected, the near-end of buffer tube is connected outside the pipe, the far-end of buffer tube with it connects to be connected the near-end. The invention has accurate positioning in blood vessels, can provide expansion force far greater than that of the traditional structure, can effectively expand highly calcified lesion parts, improves the utilization rate of medicaments, reduces blood vessel injuries and reduces restenosis rate, and is worthy of popularization and application in the field.

Description

Cutting-reinforced balloon assembly and balloon catheter system

Technical Field

The invention relates to the technical field of medical instruments, in particular to a balloon assembly for strengthening cutting action and a balloon catheter system.

Background

The invasive use of percutaneous transluminal angioplasty is a significant advance in the treatment of vascular disease. Over the course of 20 years, balloon angioplasty has been a well-established technique that is well recognized in the medical community. Balloon angioplasty is primarily directed to revascularization of stenotic, occluded vessels by inserting a catheter with an inflatable balloon into the vascular system, which is inflated within the stenotic, occluded region in the vessel under externally released pressure so as to apply radial pressure to the inner wall of the vessel, widening the stenotic, occluded region and improving blood flow.

Conventional balloon angioplasty is performed by introducing a balloon into a diseased blood vessel and expanding the balloon to open the diseased blood vessel, as disclosed in CN201320567219.0 patent application, which includes: the balloon body, an inner tube, a double-cavity catheter, a liquid injection handle and a guide wire port, wherein the inner tube is arranged inside the balloon body and penetrates through the balloon body, the inner tube is sleeved at the front end of the double-cavity catheter, and the liquid injection handle is arranged at the rear end of the double-cavity catheter; the guide wire opening is arranged on the side wall of the front end of the double-cavity catheter, the guide wire opening divides the double-cavity catheter into two cavities, and the two cavities are respectively: filling cavity way and seal wire cavity way, filling cavity way with annotate the liquid handle intercommunication, seal wire cavity way with the inner tube intercommunication.

However, conventional balloon angioplasty also suffers from a number of other deficiencies. Such as: (1) restenosis problems, in some cases, damage to the vessel during balloon catheter expansion due to balloon over-inflation, which can stretch the patient's vessel beyond its elastic limit, damage the vessel wall and result in restenosis of the vessel in the area of over-inflated balloon expansion; (2) vessel recoil, conventional balloons are difficult to treat fibrotic lesions, and post-dilation vessel recoil is often observed after treatment of these lesions. Conventional balloons are also difficult to treat due to fibrotic lesions in long diseased vessels; (3) in the process of pre-expanding the saccule for treating serious hard calcified lesion, the pressure applied to the hard calcified part of the blood vessel by the saccule is insufficient due to the insufficient performance of the conventional saccule, the blood vessel can not be effectively expanded, the saccule is easy to form a dog bone phenomenon or the saccule slides during the expansion process, and the injury to the blood vessel wall around the treated lesion can be possibly caused. If the stent implantation is performed immediately after the balloon dilatation, failure of balloon angioplasty to properly widen the stenosed vessel may result in inaccurate positioning of the stent in the vessel, which may result in a higher rate of stent restenosis and, if a drug stent is used, may impair the effectiveness of the drug stent.

To overcome some of the above problems, blade cutting balloons, single or multiple cutting wire cutting balloons have been developed in the prior art. Wherein the blade cutting balloon is a technology that adds a cutting blade into the balloon, and the cutting blade cuts plaque tissues on the inner wall of the blood vessel while the balloon is expanded. A cutting balloon for treating intravascular thrombosis and calcified lesions as disclosed in patent document CN201320563684.7, comprising a balloon and a plurality of rows of blades axially mounted on the outer circumferential surface of the balloon, wherein a certain gap is provided between two adjacent blades in each row of blades, each blade is fixed on the balloon via a sleeve fixed on the outer circumferential surface of the balloon, and a certain gap is provided between two adjacent sleeves in the axial direction of the balloon.

The cutting balloon with one or more cutting wires is a technology for fixing the cutting wires on the surface of the balloon, and the cutting wires are embedded into plaque tissues on the inner wall of a blood vessel while the balloon is expanded, so that the effect of effectively fixing and tearing the plaque tissues is achieved. A cutting balloon as disclosed in patent document No. cn201810478242.x, comprising: a balloon body; the cutting wires are arranged along the outer surface of the balloon body in the radial direction; two ends of the cutting wire are respectively fixed at two ends of the balloon body; the cutting wire comprises a folded structure.

While there are significant advantages to using a blade cutting balloon or a wire cutting balloon in many instances, there are technical drawbacks. The blade type cutting saccule is very hard due to the fact that the cutting blades are adhered to the saccule, the whole trafficability of the saccule is poor, and the ability of the saccule entering a bent blood vessel or a smaller blood vessel is limited. In addition, cutting blades outside the balloon may also affect the deflation of the balloon, making the withdrawal of the cutting balloon from the blood vessel more difficult than conventional balloons and more prone to vascular injury during withdrawal, causing surgical complications leading to risks and possibly life threatening. Because the cutting wires are completely fixed at the near end and the far end of the balloon, the balloon is easy to deform in a banana shape in the balloon expansion process, so that the stress of a lesion part is uneven, the cutting effect cannot reach the expectation, and the balloon is gradually pressurized in the balloon expansion process to prevent the cutting wires from being wound together due to the fact that the pressurization is too fast. In addition, in the prior art, the cutting position can be presumed to perform balloon dilatation under the X-ray in the operation process only by the position of the developing ring on the balloon catheter, the position of the cutting blade or the cutting wire cannot be determined, the cutting condition of the cutting blade or the cutting wire on the blood vessel cannot be determined, and the phenomena of injury to the normal blood vessel and insufficient or excessive cutting of the diseased blood vessel can be caused.

In addition to the above, drug-coated balloons (DEBs) and drug-eluting stents (DES) reduce the incidence of restenosis by inhibiting vascular inflammatory responses and endothelial cell proliferation through the use of coated drugs such as paclitaxel or rapamycin. Among them, a drug-coated balloon (DEB) is a new balloon appearing in recent years, which is coated with a drug that inhibits cell proliferation, and when the balloon is expanded, the drug is rapidly transferred from the balloon surface to the blood vessel wall to inhibit endothelial cell proliferation. For example, patent document CN201720958767.4 discloses a drug-coated balloon catheter, which includes a push catheter with a certain axial length, at least one drug-coated balloon disposed at the distal end of the push catheter, and a sheath movably sleeved outside the drug-coated balloon, wherein 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 expanding a blood vessel, the drug balloon needs to completely open the lumen of the blood vessel, and the simple drug balloon is the same as the conventional balloon, so that calcified or fibrotic blood vessels cannot be effectively expanded.

Drug Eluting Stents (DES) also inhibit endothelial cell proliferation by their coated drug. A drug eluting stent as disclosed in patent document No. CN201620231313.2, which is composed of a stent base and a drug coating layer coated on the inner surface of the stent base, the drug coating layer having a three-layer structure of a degradable polymer layer, a drug layer and a degradable polymer layer in this order from a layer contacting the stent base. But the nonuniformity of the drug release at the intersection of the stent struts and the stimulation of the carrier to the vessel wall after the drug release can increase the restenosis rate of the stent. Furthermore, Drug Eluting Stents (DES) are not suitable for every patient, and patients implanted with DES stents need to maintain an anticoagulant treatment regimen for extended periods of time to minimize the risk of late thrombosis for those who are unable to receive anticoagulant treatment or who are not advised of a possible need for surgery.

Currently, an emerging angioplasty medium combines a balloon with a constraining stent wrapped outside the balloon, for example, a cutting balloon disclosed in patent document CN201721473170.7, includes an inner lumen, the inner lumen passes through a balloon body, a cutting net is wrapped outside the balloon body, and both ends of the balloon body and the cutting net are fixed on the inner lumen through a pressing device; one end of the inner tube cavity is a tip. However, in practical use, the scheme has limited cutting effect, still easily causes thrombus or plaque migration, has poor effect of expanding highly calcified lesion parts, is easy to generate unnecessary vascular injury, has high restenosis incidence rate and has poor overall interventional therapy effect.

Disclosure of Invention

One of the technical objects of the present invention is to provide a balloon assembly with enhanced cutting effect, which solves the problems of inaccurate balloon positioning and limiting, limited cutting effect on the blockage at the lesion site, and poor interventional therapy effect caused by insufficient expansion force on the blood vessel at the lesion site in the prior art.

The specific technical scheme of the invention is as follows: the utility model provides a reinforce sacculus subassembly of cutting effect, includes the sacculus and wraps up in the outside metal mesh of sacculus, the metal mesh is including connecting the near-end, connecting the distal end and connecting the effect section between the two, connect the distal end with the distal end of sacculus is connected, the dispersion is equipped with a plurality of supplementary cutting elements on the effect section.

In the scheme, the auxiliary cutting element is further arranged on the basis of the action section, so that the cutting action of the metal net is further optimized and enhanced, even if a highly calcified lesion part is subjected to effective expansion of the balloon, the medicine can be fully absorbed more easily, the interventional therapy effect is improved, and the occurrence rate of restenosis is reduced.

Preferably, the action section comprises a plurality of connecting rods, the auxiliary cutting elements are arranged on the connecting rods, the connecting proximal end and the connecting distal end are both circumferential windings with sawtooth waveforms, and peaks at wave crests or wave troughs on the circumferential windings are connecting points with the action section.

The connecting rod is matched with the auxiliary cutting element on the connecting rod to cut a lesion part, and meanwhile, the connecting rod is used as a restraining tool in balloon expansion to enable the balloon to controllably and uniformly expand a blood vessel.

Preferably, the action section comprises a plurality of transition connection portions and a plurality of segments separated by the transition connection portions, the segments comprise a plurality of connecting rods, the auxiliary cutting element is arranged on the connecting rods, the connection proximal end, the connection distal end and the transition connection portion are all circumferential windings with sawtooth waveforms, and peaks at crests or troughs on the circumferential windings are connection points with the connecting rods.

The segmented form avoids that a single connecting rod is too long, and the transitional connection part is combined, so that the structural strength of the acting section is improved, the cutting effect is ensured to be optimized along with the expansion process of the saccule, and meanwhile, the knotting and twisting-off are avoided.

Preferably, the length of the segments is 20-30 mm.

Preferably, the auxiliary cutting member has a wing portion extending to one side or both sides in the width direction of the connecting bar.

The side wing part is used as a cutting main body, and in the expansion process of the metal net along with rotation, the side wing part is used as a cutting point to circumferentially perform circular cutting on a lesion part, so that the elasticity and fiber continuity of the lesion part can be cut off, the migration of thrombus or plaque is reduced, the cutting effect is further enhanced relative to the connecting rod, and the balloon in the scheme has stronger expansion force compared with the traditional balloon, effectively expands and improves the release and absorption of medicines.

Preferably, the top surface of the wing portion is a flat surface or a curved surface with an upward-tilted end or a downward-bent end.

The end part of the top surface of the side wing part can play a stronger cutting role and can be more easily penetrated into the tube wall of a lesion part for circular cutting.

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

The design is such that the bottom surface of the wing part does not present a sharp place and is not easy to puncture and damage the balloon surface.

Preferably, the auxiliary cutting elements provided on any two of the connecting rods are offset from each other in the circumferential direction of the active segment.

The design is such that the auxiliary cutting elements do not interfere in the circumferential direction, i.e. do not snag together, with the balloon in the collapsed state of the metal mesh or during expansion of the metal mesh with the balloon (with irregular twisting).

Preferably, each of said connecting rods is provided with one of said auxiliary cutting elements.

On the basis of realizing the design that the auxiliary cutting elements are staggered in the circumferential direction, the manufacturing process is relatively simple, the manufacturing cost is low, and the structure is simplified.

Preferably, the auxiliary cutting element is integrally formed with the connecting rod; or the auxiliary cutting element is an independent part connected and fixed with the connecting rod.

Preferably, the auxiliary cutting element is provided with a first butting part, the connecting rod is provided with a second butting part, and the first butting part is matched with the second butting part and is fixedly connected with the second butting part.

Preferably, the auxiliary cutting element is a light-impermeable element.

The auxiliary cutting element has light-tight property, and in the expansion process of the balloon, the cutting depth of the connecting rod and the auxiliary cutting element can be effectively judged by combining the use of contrast medium, so that the cutting process can be monitored in real time, excessive cutting is avoided, the damage to endothelial cells and blood vessels is reduced, and the incidence rate of restenosis is reduced.

Preferably, the connection points to which both ends of the connection rod are connected are shifted in the axial direction and are formed in a spiral shape in the circumferential direction.

The spiral arrangement form of the connecting rod enables the action section to be accompanied with certain rotation relative to the blood vessel in the process of expanding along with the saccule, so that the connecting rod and the auxiliary cutting element on the connecting rod can be used for fully cutting the vascular lesion.

Preferably, the metal net is longer than the balloon by 1-100 mm.

The metal mesh can be completely wrapped outside the balloon, and the balloon is not pressed too tightly, so that the metal mesh can be expanded softly and uniformly along with the balloon.

Another technical object of the present invention is to provide a balloon catheter system, which solves the problems of inaccurate balloon positioning and limiting, limited cutting effect on the blockage at the lesion site, and insufficient expansion force on the blood vessel at the lesion site in the prior art, resulting in poor interventional therapy effect.

The specific technical scheme of the invention is as follows: a balloon catheter system comprising a catheter, further comprising a buffer tube and a balloon assembly as described above, the catheter passing through the buffer tube and being connected to the proximal end of the balloon, the buffer tube having a proximal end connected outside the catheter, the buffer tube having a distal end connected to the proximal end of the connection.

The balloon component in the scheme is provided with the action section and the auxiliary cutting element thereon, so that the cutting action of the metal net is further optimized and enhanced, and even a highly calcified lesion part can be effectively expanded, so that medicines are more easily and fully absorbed, the interventional therapy effect is improved, and the occurrence rate of restenosis is reduced.

Preferably, the buffer tube is a plastic polymer material tube or a metal tube engraved by a spiral or pi-shaped laser.

The buffer tube may be deformed in an axial direction to compensate for axial shortening of the metal mesh structure of the balloon assembly during expansion.

Preferably, the buffer tube is an optically opaque tube.

The balloon component and the balloon catheter system have the following advantages:

1. the metal net is arranged on the outer surface of the drug coating balloon, the acting section can help the balloon to be locked in place at a blood vessel pathological change section, the balloon is prevented from slipping in the expansion process or after expansion like the traditional naked balloon, the accurate positioning of the balloon is realized, and the damage to good blood vessels around pathological changes is avoided;

2. the balloon is accurately positioned and limited, so that the release of a drug coating is facilitated, the release of the drug in a non-pathological section of a blood vessel is avoided, the utilization rate of the drug is improved, the intimal hyperplasia of the blood vessel after an operation is more effectively inhibited, the restenosis of the blood vessel is prevented, and the treatment effect is improved;

3. the metal net is circumferentially unfolded along with the expansion of the balloon, firstly contacts the diseased position of the blood vessel in one step, cuts the diseased part, and simultaneously expands uniformly along with the balloon, so that the expansion injury is reduced, the occurrence of irregular tearing of the inner membrane is reduced, the injury of endothelial cells is reduced to the maximum extent, and compared with a blade type cutting balloon or a cutting wire type cutting balloon, the patch at the diseased position can be further optimized, the incidence rate of an interlayer and acute vessel occlusion are greatly reduced, and the implantation rate of a remedial stent is reduced;

4. the auxiliary cutting element protrudes out of the connecting rod laterally, the cutting effect is further strengthened by matching with the connecting rod, the elasticity and the fiber continuity of the closed lesion part can be cut off in a circular mode along with the expansion and rotation of the metal net, the migration of thrombus or plaque is reduced, the shearing force and the radial force in the expansion process of the balloon are reduced, unnecessary blood vessel injury is avoided, compared with the traditional balloon, the balloon expanding device can provide 15-25 times of expansion force, the highly calcified lesion part can be expanded effectively, and the drugs are enabled to be released and absorbed fully.

Drawings

FIG. 1 is a schematic overall structure diagram of an embodiment of the present invention;

FIG. 2 is a schematic structural view of an embodiment of the action section of the present invention consisting of only connecting rods;

FIG. 3 is a schematic structural diagram of an embodiment of the auxiliary cutting unit integrally formed with the connecting rod according to the present invention;

FIG. 4 is a schematic structural diagram of an embodiment of the auxiliary cutting unit integrally formed with the connecting rod according to the present invention;

FIG. 5 is a schematic structural view of an embodiment of an auxiliary cutting unit assembled and connected with a connecting rod according to the present invention;

FIG. 6 is a schematic structural diagram of an embodiment of the action section of the present invention comprising a connecting rod and a transition connecting portion;

FIG. 7 is a schematic diagram of the construction of a buffer tube in an embodiment of the invention;

the names of the parts corresponding to the numbers in the figure are respectively: 1-balloon, 2-metal mesh, 21-proximal junction, 22-distal junction, 23-active segment, 231-connecting rod, 232-transition junction, 3-auxiliary cutting element, 31-flank section, 32-main body section, 4-catheter, 5-buffer tube, a-first interface, b-second interface.

Detailed Description

The invention will be further illustrated by means of specific embodiments in the following description with reference to the accompanying drawings:

referring to fig. 1, an embodiment of a balloon catheter system includes a balloon component for enhancing cutting action, a catheter 4 and a buffer tube 5, the balloon component includes a balloon 1 and a metal mesh 2 wrapped outside the balloon 1, the metal mesh 2 includes a connection proximal end 21, a connection distal end 22 and an action section 23 connected therebetween, the connection proximal end 21 and the connection distal end 22 are circumferential windings of a sawtooth waveform, the peak of the peak or the valley of the circumferential windings is a connection point with the action section 23, and the action section 23 is provided with a plurality of auxiliary cutting elements 3; catheter 4 is passed through buffer tube 5 and attached to the proximal end of balloon 1, the proximal end of buffer tube 5 being attached to the outside of catheter 4, and the distal end of buffer tube 5 being attached to attachment proximal end 21.

The surface of the balloon 1 is provided with a drug coating, in particular to the drugs for promoting the endometrial hyperplasia such as paclitaxel, rapamycin and the like. The metal net 2 is made of a material with a shape memory function by a carving or weaving method, and the more common manufacturing method is to cut a nickel-titanium alloy tube by laser or weave nickel-titanium alloy wires. The length of the metal mesh 2 is 50mm greater than the length of the balloon 1. The far end of the buffer tube 5 is connected with the near connection end 21, and the far end of the balloon 1 is connected with the far connection end 22, and can be connected and fixed by laser welding, hot melting, bonding and other connection modes. The buffer tube 5 is a plastic high polymer material tube or a metal tube engraved by spiral or pi-shaped laser, has a certain axial deformability, has a length variable range of about 1-15 mm, and compensates for axial shortening of a metal net in the expansion process, as shown in fig. 7; the buffer tube 5 has X-ray opaque property for positioning and tracking, and can be made of X-ray opaque material or X-ray opaque metal or plastic material.

In some embodiments, as shown in fig. 2, the action section 23 comprises a plurality of independent connecting rods 231, the auxiliary cutting element 3 is disposed on the connecting rods 231, and the connecting points in the connecting proximal end 21 and the connecting distal end 22 are correspondingly connected with the ends of the connecting rods 231. The connection points to which both ends of the connection rod 231 are connected are shifted in the axial direction and spiral in the circumferential direction.

Further, referring to fig. 3 or 4 or 5, the auxiliary cutting member 3 extends to both sides of the width direction of the connecting bar 231 to form the wing portions 31 of the opposite connecting bar 231. The flank part 31 can perform extra circumferential cutting on a diseased part in the expansion process of the metal net 2 along with rotation, cut off the elasticity and fiber continuity of the diseased part, reduce the migration of thrombus or plaque, reduce the shearing force and radial force in the expansion process of the balloon 1, strengthen the cutting effect, provide 15-25 times of the expansion force of the traditional balloon, effectively expand the highly calcified diseased part and promote the full release and absorption of the medicine.

The bottom surfaces of the wing portions 31 are smooth or rounded, as shown in fig. 3, 4 and 5, in order to ensure that the bottom surfaces of the wing portions 31 do not puncture the surface of the balloon 1, and the bottom surfaces of the wing portions 31 are also recessed in fig. 3 and 4, thereby further avoiding over-compression or puncture of the balloon 1. The top surface of the side wing part 31 is freely arranged and can be a straight surface or a curved surface, the top surface of the side wing part 31 and the top surface of the connecting rod 231 in fig. 3 and 4 are on the same straight-line curved surface, due to the relation of the manufacturing process of the metal net 2, the outer surface of the connecting rod 231 is generally the straight-line curved surface like a cylindrical side surface, the side wing part 31 is equivalently arranged as an integral extension surface of the top surface of the connecting rod 231, the integral consistency is better, if the auxiliary cutting element 3 and the connecting rod 231 are integrally formed, the manufacturing and processing difficulty is lower, the side wing part 31 is smoother and softer during cutting, and the stimulation to blood vessels is smaller. In fig. 5, the top surface of the side wing portion 31 is a curved surface with an outward-warped end, which can further enhance the cutting effect on the lesion site, and the cutting depth of the lesion site is deeper, so that the elasticity and the fiber continuity of the lesion site are relatively effectively cut off, the shearing force and the radial force in the expansion process of the balloon are relatively greatly reduced, and the balloon 1 has a stronger expansion capability on the blood vessel.

Further, the auxiliary cutting elements 3 provided on any two connecting rods 231 are offset from each other in the circumferential direction of the active segment 23, in order to prevent a plurality of auxiliary cutting elements 3 from interfering with each other on the same circumferential path to "fight" the frame. In fig. 2 (and fig. 6), each connecting rod 231 is provided with an auxiliary cutting element 3, the auxiliary cutting elements 3 are arranged on the acting section 23 in a spiral manner, and the auxiliary cutting elements 3 on different connecting rods 231 are staggered with each other, so that the interference avoiding effect and the low arrangement complexity and cost are both considered. Of course, providing more auxiliary cutting elements 3 on each connecting rod 231 can increase the cutting effect on the blood vessel of the lesion, or in case of more connecting rods 231, the auxiliary cutting elements 3 can also have more cutting coverage areas in the axial direction, i.e. more cutting sites on the blood vessel of the lesion in the axial direction.

There are two ways of forming and connecting the auxiliary cutting element 3, one is to integrally form the auxiliary cutting element 3 and the connecting rod 231, for example, the connecting rod 231 and the auxiliary cutting element 3 are directly and simultaneously processed when the metal mesh 2 is laser cut, as shown in fig. 3 and 4. The auxiliary cutting element 3 may also be a separately manufactured individual, as shown in fig. 5, a first abutting portion a is disposed on the main body portion 32 between the two wing portions 31, a second abutting portion b is disposed on the connecting rod 231, the first abutting portion a and the second abutting portion b are matched and fixedly connected, where the first abutting portion a and the second abutting portion b are matched abutting grooves (or two abutting surfaces that are fitted together, or the first abutting portion a is a non-grooved section and the second abutting portion b is a grooved section, or in the form of a hole and a post, a groove and a block that are inserted together), and are connected by laser welding, heat melting, bonding or mechanical fixing (such as a ferrule, a buckle), and the grooves are combined such that the auxiliary cutting element 3 does not protrude beyond the connecting rod 231 in the longitudinal direction, i.e. the top surface thereof does not excessively protrude beyond the top surface of the connecting rod 231, and the integrity of the two is better, and the blood vessel can not be excessively pressed and cut after the expansion. In fact, the embodiment of fig. 3 and 4 can also be regarded as an auxiliary cutting element 3 comprising two wing parts 31 as separate elements, the end faces of the wing parts 31 being connected to the side faces of the connecting rods 231 by laser welding, heat fusion, adhesive bonding or mechanical fastening.

The auxiliary cutting element 3 can be further made into a non-transparent element, such as a metal or plastic that is completely opaque to X-rays, or a metal or plastic that is opaque to X-rays can be added during the manufacturing process. A better result is achieved with respect to the non-transparent auxiliary cutting element 3. The cutting depth of the connecting rod 231 and the auxiliary element 3 can be effectively judged by combining a contrast medium in interventional therapy, the cutting process is tried to be monitored, excessive cutting is avoided, damage to endothelial cells and blood vessels is reduced, and the incidence rate of restenosis is reduced.

In still other embodiments, the active segment 23 includes a plurality of transition connection portions 232 and a plurality of segments separated by the transition connection portions 232, one transition connection portion is generally disposed at intervals of 20-30 mm, each segment includes a plurality of connection bars 231, the auxiliary cutting element 3 is disposed on the connection bars 231, the transition connection portions 232 are also a circumferential winding of a sawtooth waveform, the vertex of the two sides of the circumferential winding at the wave crest or the wave trough is a connection point with the connection bars 231, and the connection points of the transition connection portions 232, the connection proximal ends 21 and the connection distal ends 22 are connected with the corresponding end portions of the connection bars 231. Fig. 6 shows an example of a transition connection part 232 and two segments, the length of the segments is selected to be 25mm (within a range of 20 mm-30 mm), because when the segments are too long, that is, a single connecting rod 231 is too long, the structural strength can be reduced, the connecting rod 231 can also be mutually interfered by torsion in the expansion process to form a frame, the connecting rods 231 at different positions in the axial direction have larger difference along with the expansion condition of the balloon 1, and cannot be normally expanded, or even can be wound and twisted off, and the transition connection part 232 ensures that the whole action section can be normally expanded.

It will be appreciated by persons skilled in the art that the embodiments of the invention described above and shown in the drawings are given by way of example only and are not limiting of the invention. The objects of the present invention have been fully and effectively accomplished. The functional and structural principles of the present invention have been shown and described in the embodiments, and any variations or modifications may be made to the embodiments of the present invention without departing from the principles.

Claims (15)

1. A balloon assembly for enhancing cutting action, comprising a balloon (1) and a metal mesh (2) wrapped outside the balloon (1), the metal mesh (2) comprising a proximal end (21), a distal end (22) and an action section (23) connected therebetween, the 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).

2. A cutting-enhancing balloon assembly as in claim 1 wherein: the action section (23) comprises a plurality of connecting rods (231), the auxiliary cutting elements (3) are arranged on the connecting rods (231), the connection proximal end (21) and the connection distal end (22) are circumferential windings with sawtooth waveforms, and peaks at wave crests or wave troughs on the circumferential windings are connection points with the connecting rods (231).

3. A cutting-enhancing balloon assembly as in claim 1 wherein: the action section (23) comprises a plurality of transition connection parts (232) and a plurality of segments separated by the transition connection parts (232), each segment comprises a plurality of connecting rods (231), the auxiliary cutting element (3) is arranged on each connecting rod (231), the connection near end (21), the connection far end (22) and the transition connection parts (232) are circumferential windings with sawtooth waveforms, and peaks or troughs on the circumferential windings are connection points with the connecting rods (231).

4. A cutting-enhancing balloon assembly as in claim 3 wherein: the length of the segments is 20-30 mm.

5. A cutting-enhancement balloon assembly according to claim 2 or 3, wherein: the auxiliary cutting member (3) has a side wing portion (31) extending to one side or both sides in the width direction of the connecting rod (231).

6. A cutting-enhancing balloon assembly as in claim 5 wherein: the top surface of the side wing part (31) is a straight surface or a curved surface with an upward-warped or downward-bent end part.

7. A cutting-enhancing balloon assembly as in claim 5 wherein: the bottom surfaces of the wing parts (31) are smooth or rounded surfaces.

8. A cutting-enhancing balloon assembly as in claim 5 wherein: the auxiliary cutting elements (3) arranged on any two of the connecting rods (231) are offset from each other in the circumferential direction of the active segment (23).

9. A cutting-enhancing balloon assembly as in claim 8 wherein: each connecting rod (231) is provided with one auxiliary cutting element (3).

10. A cutting-enhancing balloon assembly as in claim 5 wherein: the auxiliary cutting element (3) is integrally formed with the connecting rod (231); or the auxiliary cutting element (3) is an independent element fixedly connected with the connecting rod (231).

11. A cutting-enhancing balloon assembly as in claim 10 wherein: the auxiliary cutting element (3) is provided with a first butt joint part (a), the connecting rod (231) is provided with a second butt joint part (b), and the first butt joint part (a) and the second butt joint part (b) are connected and fixed in a matched mode.

12. A cutting-enhancement balloon assembly according to claim 2 or 3, wherein: the connection points to which both ends of the connection rod (231) are connected are staggered in the axial direction and spiral in the circumferential direction.

13. A cutting-enhancing balloon assembly as in claim 1 wherein: the metal net (2) is longer than the balloon (1) by 1-100 mm.

14. A balloon catheter system comprising a catheter (4), characterized in that: further comprising a buffer tube (5) and a balloon assembly according to any of claims 1-13, the catheter (4) being passed through the buffer tube (5) and being connected to the proximal end of the balloon (1), the proximal end of the buffer tube (5) being connected outside the catheter (4), the distal end of the buffer tube (5) being connected to the proximal connection end (21).

15. The balloon catheter system of claim 14, wherein: the buffer tube (5) is a plastic high polymer material tube or a metal tube carved according to spiral or pi-shaped laser.

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