CN110270002B

CN110270002B - A balloon-constrained stent with cutting function and a vascular dilation device using the stent

Info

Publication number: CN110270002B
Application number: CN201910549448.1A
Authority: CN
Inventors: 杨威; 杜瑞林; 马兰坤; 邹洋; 陈丽君; 叶金华; 颜玉强
Original assignee: Hangzhou Barty Medical Technology Co ltd
Current assignee: Hangzhou Barty Medical Technology Co ltd
Priority date: 2019-06-24
Filing date: 2019-06-24
Publication date: 2025-02-28
Anticipated expiration: 2039-06-24
Also published as: CN110270002A

Abstract

The balloon restriction stent with the cutting function comprises a main body area, an implantable vascular dilation device and a balloon restriction stent, wherein the main body area is provided with a first state for being contracted together with a balloon and a second state for being expanded together with the balloon, the main body area comprises a restriction ring and a cutting section, the implantable vascular dilation device with the cutting function comprises the balloon, and the balloon restriction stent with the cutting function further comprises a convex annular belt and a concave annular belt which are alternately arranged after the balloon is wrapped and limited by the restriction ring. Compared with the prior art, the invention has the advantages that the structure is simple, better dredging effect can be achieved, the constraint bracket has the functions of constraint and cutting, the treatment process of the vasodilator has controllability and predictability, the treatment effect is greatly improved, the occurrence probability of injury and complications to blood vessels is reduced, the treatment effect of balloon forming operation is improved, the method has guiding significance for the treatment of complex plaque lesions, and the method is worthy of popularization and use in the field.

Description

Saccule restraining support with cutting function and vessel dilating device using the same

Technical Field

The invention relates to the technical field of angioplasty, in particular to a balloon restriction stent with a cutting function and a vasodilation device using the stent.

Background

Balloon angioplasty is one of the most common treatments for cardiovascular disease. The traditional balloon catheter is manufactured into the inflated cylindrical balloons with different diameters and lengths according to the size of a blood vessel of a patient and the length of a lesion position, and the working principle is that one balloon dilation catheter is placed at the lesion position by using a conveying system, and the blood vessel is dilated after the balloon is inflated, so that the lumen is dilated.

Conventional balloon angioplasty is often accompanied by vascular injury, such as due to balloon proximal and distal diameters greater than balloon central diameters during balloon inflation, i.e., the "dog bone effect", resulting in over-dilation of the blood vessels in contact with the balloon ends, resulting in vascular wall injury and longitudinal balloon elongation accelerating vascular dissection (> 30%), while acute vascular occlusion (5% -12%) and post-operative restenosis (50%) of the lesion site may be induced. Vascular dissection, acute vascular occlusion, vascular wall injury are vascular wounds created by traditional balloon angioplasty, and traditional balloon angioplasty itself is not sufficiently successful in dredging the lumen.

In order to eliminate the "dog bone effect", it is important to design PTCA/PTA balloons with constraining stents, and existing balloons begin to incorporate constraining stents to solve this problem. As disclosed in patent document CN102939125A, an angioplasty balloon is provided with an elastic limiting structure, when the balloon is inflated, the elastic limiting structure draws square areas which are uniformly distributed on the balloon to form a "pillow" pattern, the balloon has a limitable inflation form, which can reduce vascular injury, but in clinical application, the action force of the balloon catheter formed by the scheme on plaque in the lumen can be greatly reduced, but the plaque cannot be effectively compressed and removed, so that the efficacy of dredging the blood vessel is greatly compromised.

Disclosure of Invention

One of the technical purposes of the invention is to provide a balloon restraint stent with a cutting function, which can limit the expansion of a balloon, effectively control and keep stable the expansion rate and the expansion size of the balloon, reduce the damage of the balloon to a blood vessel, cut plaque and dredge the blood vessel effectively compared with the prior art.

The invention relates to a balloon restraint bracket with a cutting function, which comprises a main body area, wherein the main body area is provided with a first state for being wrinkled together with a balloon and a second state for being inflated together with the balloon, the main body area comprises restraint rings and cutting sections, the restraint rings are arranged at intervals along the length direction of the restraint bracket and form a spacing space, the restraint rings are used for pressing a part of the body of the balloon to limit the balloon to be fully inflated, the spacing space is used for enabling the rest of the body of the balloon to be inflated outwards to be bulged, a plurality of cutting sections are connected between every two adjacent restraint rings, and the cutting sections are used for being adhered and covered by conforming to the surface of the rest of the body of the bulged balloon.

The balloon restraint bracket is made of a telescopic memory material, can expand/contract along with the expansion/contraction of the balloon, the main body area is correspondingly wrapped outside the expansion main body of the balloon, the restraint ring mainly limits the balloon catheter to be fully or excessively expanded, the whole balloon is limited to be expanded, the effect of a dog bone is effectively avoided, the trauma to a lesion blood vessel is reduced, the restraint rings which are axially arranged at intervals enable the balloon to form a circle of bulges and a circle of hollows which are circumferentially alternated during the expansion of the balloon, the function of remolding the blood vessel plaque is guaranteed, the cutting section is clung to the surface of the bulge part of the balloon during the expansion of the balloon, the acting force is generated along with the balloon, the broken blood vessel plaque is cut, and the purpose of effectively dredging the blood vessel is achieved.

Preferably, the relative arrangement of the cutting segments between two adjacent confinement rings includes a spaced apart arrangement and/or a crossed arrangement.

The cutting sections can be horizontally and obliquely arranged at intervals, the interval arrangement can be uniform or nonuniform, or the cutting sections can be obliquely and crosswise arranged, so that various adaptive and targeted cutting means can be provided according to actual pathological changes, and the problem of complex vascular plaque pathological changes is effectively solved.

Preferably, the cutting segment comprises a straight line segment and/or a curved line segment.

The linear cutting section has simpler processing and more stable effect, and the curved cutting section has more cutting contact surfaces and provides better plaque cutting effect.

Preferably, the cutting section is provided with a cutting portion.

Preferably, the cutting portion is a micro blade.

Compared with the independent cutting section body, the miniature blade can more effectively and easily cut off the elasticity and fiber continuity of the wall of the lesion part, reduce the migration of plaque and further achieve the treatment effect.

Preferably, the cutting portion is a plurality of teeth.

Each of the teeth may more easily and effectively sever successive plaque than the cutting segment body alone, the tooth slots between the teeth providing room for a closed elastic return, reducing trauma to the vessel wall.

Preferably, the connection mode of the constraint ring and the cutting section comprises fixed connection and/or movable connection.

The relatively fixed connection mode is easy to realize, has a relatively stable effect, but cannot effectively treat complex plaque lesions, and the relatively movable connection mode allows the cutting section to relatively move on the constraint ring, so that the movable cutting can be realized for complex plaque lesions which cannot be cut at one time, and the treatment effect of the balloon operation is improved.

Preferably, the fixed connection mode is welding, cementing or hot melting connection.

Preferably, the fixed connection mode is that the constraint ring is in a crossing position with the corresponding cutting section and is in binding connection with the corresponding cutting section through a connecting wire.

The binder connection can avoid producing residual stress at the tie point like integrated into one piece connects to reduce the risk of easy messenger's structure damage, and binder connection can with the cutting section dismouting, the confinement ring with the cutting section separates and realizes modularization processing, improves production efficiency, reduction in production cost.

Preferably, the movable connection mode is that the constraint ring and the corresponding cutting section are intersected, a connecting key is connected to the cutting section at the intersection, and a sleeving space for the constraint ring to pass through is formed between the connecting key and the cutting section so that the connecting key is sleeved on the constraint ring relatively.

The connecting key enables the constraint ring to be connected with the cutting section in a non-fixed mode, the cutting section can move along the circumferential direction of the constraint ring, targeted mobile cutting is achieved, and complex plaques are effectively treated.

Preferably, the constraining scaffold further comprises a balloon end connection region.

The balloon end connecting areas are connected to two ends of the main body area and are used for being fixedly connected with the distal end and the proximal end of the balloon.

The invention further aims to provide a vascular dilation device applying the constrained stent, which has the advantages of controlled dilation rate and dilation size, stable final maintenance, small damage to blood vessels, sufficient plaque acting force in the dilation process, capability of cutting plaque, effective remodeling and plaque breaking, and great improvement of vascular dredging effect.

The invention relates to an implantable vasodilation device with a cutting function, which comprises a balloon and the balloon restraint bracket, wherein the balloon is wrapped and limited by the restraint ring to form alternately arranged convex endless belts and concave endless belts after expansion, and the cutting section is adhered to the surface of the convex endless belt of the balloon in a compliant manner.

The restriction ring limits the balloon inflation and forms protruding and sunken appearance between adjacent restriction ring at messenger the sacculus, can effectively remodel the plaque, can reduce vascular injury again, and on this basis, the cutting section is hugged closely on the sacculus surface of inflation, has the cutting effect, can effectively cut the plaque.

The invention has the technical advantages that the restraint bracket and the vessel expansion device have simple structures, can achieve better dredging effect compared with the prior art, have the functions of restraint and cutting, ensure that the balloon expands softly and uniformly, avoid the radial force and the axial force which cause damage to the vessel wall due to over-quick and over-expansion, divide the balloon into a convex annular belt and a concave annular belt by utilizing the restraint ring, ensure that the balloon has enough acting force on the plaque, and pertinently cut and break the plaque by utilizing the cutting section, have controllability and predictability in the treatment process of the vessel expansion device, greatly improve the treatment effect, reduce the occurrence probability of damage and complications to the vessel, improve the treatment effect of the balloon forming operation, have guiding significance for the treatment of complex plaque lesions, and are worthy of popularization and use in the field.

Drawings

FIG. 1 is a schematic view of a structure of a constraining scaffold of an embodiment of the present invention in a first state when it is collapsed (shown separated from the balloon);

FIG. 2 is a schematic view of a structure of a constraining scaffold of an embodiment of the present invention in a second state when inflated (shown separated from the balloon);

FIG. 3 is a schematic view of an arrangement of confinement rings and cutting segments in accordance with an embodiment of the present invention;

FIG. 4 is a schematic illustration of a cinch connection of a confinement ring to a cutting segment in accordance with an embodiment of the present invention;

FIG. 5 is a schematic illustration of the movable connection of the confinement rings to the cutting segment in accordance with an embodiment of the present invention;

FIG. 6 is a schematic view of a cutting portion of a micro blade according to an embodiment of the present invention;

FIG. 7 is a schematic view of a cutting portion with teeth according to an embodiment of the present invention;

The names of the parts corresponding to the numbers in the figure are respectively 1-main body area, 2-constraint ring, 3-cutting section, 31-microblade, 32-convex tooth, 4-connecting line, 5-connecting key, 6-saccule, 7-saccule connecting area, 71-transition part and 72-end part.

Detailed Description

The invention will be further illustrated by the following examples, taken in conjunction with the accompanying drawings:

Referring to fig. 1, an embodiment of a balloon-constrained stent with a cutting function is shown, and an embodiment of an expanding device with a balloon 6 is shown as a constrained stent wrapped with a balloon 6. The constraining scaffold comprises a body region 1 and a balloon 67, the balloon 67 comprising a transition portion 71 and an end portion 72. The main body area 1 is provided with a first state for being wrinkled together with the balloon 6 and a second state for being inflated together with the balloon 6, the main body area 1 comprises constraint rings 2 and cutting sections 3, the constraint rings 2 are arranged at intervals along the length direction of the constraint bracket and form a spacing space, the constraint rings 2 are used for pressing part of the body of the balloon 6 to limit the full inflation of the balloon 6, the spacing space is used for expanding and bulging the rest of the body of the balloon 6 outwards, a plurality of cutting sections 3 are connected between every two adjacent constraint rings 2, and the cutting sections 3 are used for being adhered and covered by conforming to the surface of the rest of the body of the balloon 6 after bulging. The balloon 6 is constrained by the constraining ring to form alternating raised and recessed zones after inflation, with the cut segments conforming to the surface of the raised zone overlying the balloon 6. The transition portion 71 may be composed of a memorized axial rod segment, and two may be provided as in the present embodiment, and the end portion 72 may be composed of a memorized circumferentially curved rod segment, and two may be provided as in the present embodiment. The right and left sides of the transition portion 71 are connected to the outermost confinement ring 2 and the tip portion 72, respectively.

Fig. 1 is a collapsed state of the constraining support, fig. 2 is a schematic view of the expanded state of fig. 1, the constraining rings 2 are in a wave shape and are axially arranged at intervals, the cutting sections 3 are connected between the constraining rings 2, and the cutting sections 3 can be selected from straight line sections or curved line sections. The peak/trough of the constraint ring 2 is generally the connection with the cutting segments 3, and the peaks/troughs of adjacent constraint rings 2 can be in one-to-one correspondence or staggered distribution, so that the connected cutting segments 3 can be transversely or obliquely arranged, the relative arrangement relation between the cutting segments 3 can be alternatively arranged at intervals or alternately arranged, and in fig. 1 and 2, the cutting segments 3 are obliquely arranged at intervals. Of course, the arrangement modes of the cutting sections 3 in different space intervals on the constraint support can also be different, as shown in fig. 3, the horizontal space arrangement and the oblique space arrangement exist, and the arrangement modes can be specifically set and manufactured according to actual processing requirements. The cutting sections 3 which are arranged in a curve manner and are obliquely arranged in a crossed manner can provide relatively larger cutting contact surface and cutting capability, can cope with more complex lesions, and further can select regular or customized irregular intervals or crossed arrangements. The constraint stent with different cutting sections 3 can be actually manufactured and selected according to the pathological condition to provide various cutting modes, and the method has important significance for solving the complex vascular plaque pathological changes.

The cutting section 3 is provided with a cutting part. The restraint support is made of metal or medical polymer material, when no cutting part exists, the cutting section 3 can complete cutting of plaque in the use process, but the cutting capacity can be further improved by arranging the cutting part. The cutting section may optionally be provided with a medical micro-blade 31 on the cutting section 3, as shown in fig. 6. The connection between the microblade 31 and the cutting segment may be simply an adhesive or snap connection, and the microblade 31 can cut off the elasticity and the limit continuity of the lesion more effectively and easily and reduce the migration of plaque than the single cutting segment 3. The inventors have also tried to provide the micro-blade 31 on the balloon 6 of the present structure, but have found that the micro-blade 31 is not preferable to be provided on the surface of the balloon 6 through experiments. In this configuration, in order to make the balloon 6 have a sufficient force on plaque after inflation compared with the prior art, there is a division of the convex annulus and the concave annulus, but if the micro-blade 31 is also provided on the balloon 6, excessive cutting occurs, and instead, there is a possibility that a large damage is caused to the inner wall of the blood vessel.

The cutting portion may also be designed in the shape of a tooth 32, preferably triangular pyramid, as shown in fig. 7. Each tooth 32 can be connected to the cutting segment by gluing, welding, hot melt forming or the like, each tooth 32 has a cutting function, continuous plaque can be cut off, and the tooth space between the two teeth 32 provides a space for the elastic recovery of the vessel wall, so that the damage to the vessel wall is reduced.

The connection mode of the restriction ring 2 and the cutting section 3 is provided with two fixed connection and movable connection, and can be selected in a targeted manner according to pathological changes. The fixed connection mode is more commonly used and is welded, glued and hot melt connected, and is more conventional, and structural strength and connection effect are all better. In addition, there is binding connection, as shown in fig. 4, specifically, there is a crossing position between the constraint ring 2 and the corresponding cutting segment 3 and binding connection is performed at the crossing position through the connecting wire 4, the connecting wire 4 can be disassembled, specifically, in a direct shearing mode, or can be knotted in advance according to a certain binding mode, and then the knotting mode is released, so that the prior art can be realized. Therefore, the modularized processing of the constraint ring 2, the cutting section 3 and the connecting wire 4 can be realized, the production efficiency is improved, the disassembly and the replacement can be carried out, the use cost is reduced by changing the phase, the binding connection can also avoid the residual stress caused by the fixedly connection of an integrated form, and the risk of structural failure is reduced.

The movable connection mode is shown in fig. 5, the constraint ring 2 and the corresponding cutting segment 3 are intersected, the cutting segment 3 at the intersection is connected with a connecting key 5, a sleeving space for the constraint ring 2 to pass through is formed between the connecting key 5 and the cutting segment 3, the connecting key 5 is sleeved on the constraint ring 2 relatively, the connecting key 5 is fixedly connected with the cutting segment 3 or detachably connected (similar to the connecting wire 4, and can be wound and then sheared or unwound), the mode also has the advantages mentioned in the binding connection mode, and the cutting segment 3 can also move circumferentially along the constraint ring 2, so that the movable cutting function is realized, and the vascular plate lesions aiming at solving the complexity are solved.

The size of the restraint bracket and the balloon 6 can be formulated into different specifications according to the size of a blood vessel, the maximum diameter of the restraint bracket after expansion is smaller than that of the balloon 6 after expansion, the expansion of the balloon 6 is limited, and the effect of a dog bone is effectively avoided. Before the expansion device is expanded, the balloon 6 is in a collapsed state and the constraining scaffold is also in a collapsed first state. At this time, the restraining stent is tightly wrapped on the surface of the balloon 6, so that the diameter of the balloon 6 is as small as possible in the collapsed state, and the restraining stent and the catheter of the balloon 6 can be inserted into or withdrawn from the blood vessel together. After the balloon 6 and the restraining stent are inflated, the balloon 6 is raised from the interval space between the restraining rings 2 to form a raised annular belt, the balloon 6 at the position of the restraining rings 2 is limited to form a recessed annular belt relatively, the raised annular belt supports the inner wall of the blood vessel and has enough and moderate acting force on plaque, the wall of the blood vessel is uniformly stressed and has good opening state, the damage to the blood vessel is smaller than that generated by the traditional balloon 6 operation while the blood vessel is uniformly and softly expanded, the recessed annular belt forms a clearance space, the tissue flow in the micro-blood vessel provides a channel, the tissue in the blood vessel is allowed to be slowly reconstructed, the wound healing is promoted, the restenosis is reduced and the risk of possibly occurring late thrombus is eliminated. In addition, the cutting segment 3 does not press the surface of the balloon 6 in the expansion process until the balloon 6 is completely expanded finally, and is adhered to the surface of the balloon 6 in a compliant manner, and a certain gap exists, so that the cutting segment 3 can be understood as an arc segment along the surface of the balloon 6 after expansion. It is not responsible for pressing the balloon 6 surface to form a concave annulus, as in conventional balloon 6 stents, so that the force of the balloon 6 on the plaque or vessel wall is eventually weakened. On the basis, the cutting section 3 can effectively cut the plaque, open the blocked blood vessel and promote blood circulation, and the cutting section 3 can play a certain cutting effect in the expansion process, mainly completely cut the plaque after the expansion is completed, and the whole position of the balloon catheter can be adjusted according to the actual pathological change condition to optimize cutting. In addition, the surface of the balloon 6 and the constrained stent can be coated with a drug-carrying coating, such as sirolimus, paclitaxel and the like, which can inhibit smooth muscle cell proliferation and reduce the probability of vascular restenosis. The technical proposal greatly improves the treatment effect and reduces the incidence of the damage to the blood vessel, namely complications.

Claims

1. A balloon restraint stent with cutting function, comprising a main body area (1), the main body area (1) having a first state for being shrunk together with a balloon and a second state for being expanded together with the balloon, characterized in that: the main body area (1) comprises a restraint ring (2) and a cutting segment (3); the restraint rings (2) are arranged at intervals along the length direction of the restraint stent to form a spacing space, the restraint ring (2) itself is used to compress a part of the balloon body to limit the full expansion of the balloon, and the spacing space is used for the remaining part of the balloon body to expand and bulge outward; a plurality of cutting segments (3) are connected between two adjacent restraint rings (2), and the cutting segments (3) are used to conform to the surface of the remaining part of the balloon body after the bulge to be attached;

The cutting section (3) is provided with a cutting portion;

The cutting portion is a tooth groove;

The cutting segment (3) comprises a straight segment and/or a curved segment;

The cutting section (3) will not exert pressure on the surface of the balloon during the expansion process, and will only adhere to the surface of the balloon in a compliant manner after the balloon is fully expanded.

2. The balloon restraint stent with cutting function according to claim 1, characterized in that the relative arrangement relationship of the cutting segments (3) between two adjacent restraint rings (2) includes an interval arrangement and/or a cross arrangement.

3. The balloon restraint stent with cutting function according to claim 1, characterized in that the connection between the restraint ring (2) and the cutting section (3) includes a fixed connection and/or a movable connection.

4. The balloon restraint stent with cutting function according to claim 3 is characterized in that the fixed connection method is welding, gluing or hot-melt connection.

5. The balloon restraint stent with cutting function according to claim 3, characterized in that: the fixed connection method is that the restraint ring (2) and the corresponding cutting segment (3) have an intersection and are tied and connected at the intersection through a connecting line (4).

6. The balloon restraint stent with cutting function according to claim 3 is characterized in that: the movable connection method is that the restraint ring (2) and the corresponding cutting segment (3) have an intersection and a connecting key (5) is connected to the cutting segment (3) at the intersection, and a sleeve space for the restraint ring (2) to pass through is formed between the connecting key (5) and the cutting segment (3) so that the connecting key (5) is relatively sleeved on the restraint ring (2).

7. An implantable vascular dilation device comprising a balloon-constrained stent with cutting function as claimed in any one of claims 1 to 6, comprising a balloon (6), characterized in that: the balloon (6) is wrapped and restricted by the constraint ring (2) to form alternating raised annular bands and recessed annular bands after expansion, and the cutting section (3) conforms to and adheres to the surface of the raised annular band of the balloon (6).