CN115501461A

CN115501461A - Wrapping type cutting balloon and balloon catheter system

Info

Publication number: CN115501461A
Application number: CN202211246192.5A
Authority: CN
Inventors: 赵旭升
Original assignee: Hengyi Beijing Medical Technology Co ltd
Current assignee: Hengyi Beijing Medical Technology Co ltd
Priority date: 2022-10-12
Filing date: 2022-10-12
Publication date: 2022-12-23

Abstract

The application relates to the technical field of cutting balloons, in particular to a wrapping type cutting balloon and a balloon catheter system. The invention provides a wrapping type cutting saccule which comprises a plurality of saccule flaps, wherein a cutting blade is clamped between every two adjacent saccule flaps and connected to the cutting saccule; the cutting saccule is provided with a crease, the saccule valve can be pressurized and outwards folded or depressurized and folded back along the crease, and the outer surface of the cutting blade and/or the cutting saccule is coated with medicine. Through set up cutting blade between sacculus lamella to make sacculus lamella can turn up or the inflection along the crease, can make cutting blade follow the deformation of sacculus and move outward or shrink along the radial of sacculus, move the in-process outward, can make cutting blade's cutting edge direct action on the pathological change position, effectively guaranteed the reliable output of cutting power, improve the cutting effect at pathological change position.

Description

Wrapping type cutting balloon and balloon catheter system

Technical Field

The application relates to the technical field of cutting balloons, in particular to a wrapping type cutting balloon and a balloon catheter system.

Background

The existing cutting saccule is generally in a spiral structure, and the side wall of the saccule is similar to an umbrella cover fan blade of a folding umbrella to wrap a cutting component before being pressurized so as to avoid cutting blood vessels in the conveying process.

When the cutting saccule reaches the lesion part, the cutting saccule is unfolded in a spiral shape in the pressurizing process so that the cutting assembly can cut the lesion tissues on the inner wall of the blood vessel.

Most of the existing drug balloons are used for attaching drugs and dispersing agents for preventing angiostenosis to the surface of the balloon through a spraying process, and then conveying the drugs and the dispersing agents to the stenotic lesion position.

The saccule conveying system enters the blood vessel, and in the processes of conveying, unfolding, expanding, withdrawing and the like, the medicine is flushed along with the flow of blood, and little medicine is released to the position of a lesion. It is more desirable that the drug can continuously and accurately act on the lesion site, improve the degree of stenosis, and prevent the occurrence of restenosis.

Secondly, the cutting blade on the existing cutting saccule can only cut the lesion part, but can not apply medicine to the lesion part at the same time of cutting, and can not form ideal operation effect.

In addition, the spiral unfolding process can cause the cutting blade to rotate along the axial direction of the balloon, so that the cutting blade is not beneficial to applying radial cutting force to a lesion part, and the cutting effect on lesion tissues is influenced.

Disclosure of Invention

The utility model aims at providing a parcel type cutting sacculus and sacculus pipe system can avoid the medicine to receive to erode in sacculus transportation process and run off, cuts simultaneously with the medicine effect at pathological change cutting position, makes the medicine release more fully to obtain better treatment.

In order to achieve the above object, in a first aspect, the present invention provides a wrap-around cutting balloon, comprising a plurality of balloon lobes, wherein cutting blades are sandwiched between adjacent balloon lobes, and the cutting blades are connected to the cutting balloon;

the cutting saccule is provided with a crease, the saccule valve can be pressurized and outwards folded or depressurized and folded back along the crease, and the outer surface of the cutting blade and/or the cutting saccule is coated with medicine.

In an alternative embodiment, the balloon petals are uniformly arranged in the radial direction of the cutting balloon, and grooves for mounting the cutting blades are provided on the outer side wall of the cutting balloon.

In an optional embodiment, the cutting blade includes a blade seat and a blade edge, the blade seat has a length greater than that of the blade edge, and protruding blocks are provided at both ends of the blade seat to be snap-fitted to the grooves.

In an alternative embodiment, the cutting balloon comprises a deformed conical cylinder section and a straight cylinder section, and the folds are arranged on the straight cylinder section in a consecutive manner.

In a second aspect, the invention provides a balloon catheter system, which includes a catheter, a push-pull tube and the cutting balloon of any one of the foregoing embodiments, wherein the cutting balloon is connected to the push-pull tube, and the push-pull tube can drive the cutting balloon to extend back and forth relative to the distal end of the catheter.

In an alternative embodiment, the push-pull tube is arranged on the cutting balloon in a penetrating manner and extends out of the far end of the cutting balloon, the cutting balloon comprises connecting blocks at two ends, and the connecting blocks are respectively connected with the push-pull tube in a sealing manner.

In an optional embodiment, a developing ring is mounted on the push-pull tube, the developing ring is arranged in the cutting balloon, and a developing tube is sleeved at the distal end of the catheter.

In an alternative embodiment, a support ring is arranged between the push-pull pipe and the guide pipe, the support ring is fixedly arranged in the push-pull pipe, and the push-pull pipe is in sealing penetrating connection with the support ring.

In an alternative embodiment, the push-pull tube is made of polyether block polyamide, and the support ring, the guide tube and the push-pull tube are concentrically arranged.

In an alternative embodiment, the medical device further comprises a guide wire, wherein the tail end of the guide wire is penetrated by the distal opening of the push-pull tube, and the proximal end of the push-pull tube extends out.

Through set up cutting blade between sacculus lamella to make sacculus lamella can turn up or the inflection along the crease, can make cutting blade follow the deformation of sacculus and move outward or shrink along the radial of sacculus, move the in-process outward, can make cutting blade's cutting edge direct action on the pathological change position, effectively guaranteed the reliable output of cutting power, improve the cutting effect at pathological change position.

The medicine coated on the outer surface of the cutting blade and/or the cutting saccule can be coated on the inner side of the cutting saccule before the saccule is deformed, so that the medicine is prevented from being washed away and lost in the conveying process; and after the saccule is deformed, the cutting blade cuts the pathological change tissue and simultaneously acts the medicine on the cutting part, so that the medicine is more fully released to the pathological change position, and a better treatment effect is achieved.

The cutting sacculus can be pressurized and turned outwards along the same track and decompressed and folded back under the action of the crease, so that multiple times of cutting of the cutting part can be realized, and the cutting effect is improved.

Additional features and advantages of the present application will be described in detail in the detailed description which follows.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are required to be used in the embodiments will be briefly described below, it should be understood that the following drawings only illustrate some embodiments of the present application and therefore should not be considered as limiting the scope, and for those skilled in the art, other related drawings can be obtained from the drawings without inventive effort.

FIG. 1 is a schematic view of a cutting balloon according to the present application;

FIG. 2 is a schematic view of the cutting balloon of the present application engaged with a catheter prior to eversion under pressure;

FIG. 3 is a schematic view of the cutting balloon of the present application mated with a blood vessel after eversion under pressure;

FIG. 4 is a schematic view of a cutting blade of the present application;

FIG. 5 is a schematic diagram of the construction of a balloon catheter system of the present application.

An icon:

1-a balloon body; 11-balloon valve; 12-folding; 13-a conical cylinder section; 14-a straight cylinder section; 15-connecting blocks;

2-a cutting blade; 21-a tool apron; 22-a blade edge; 23-a blade body; 24-a protruding block;

3-a catheter; 31-a developing tube;

4, pushing and pulling the pipe; 41-developing ring;

5-a support ring;

6-guide wire;

7-blood vessels; 71-lesion site.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. It should be apparent that the embodiments described are some, but not all embodiments of the present application. The components of the embodiments of the present application, generally described and illustrated in the figures herein, can be arranged and designed in a wide variety of different configurations.

In the description of the present application, it should be noted that the terms "inside", "outside", and the like indicate orientations or positional relationships based on orientations or positional relationships shown in the drawings or orientations or positional relationships that the product of the application is usually placed in when used, and are used only for convenience of description and simplification of the description, but do not indicate or imply that the device or element referred to must have a specific orientation, be constructed in a specific orientation, and operate, and thus, should not be construed as limiting the present application. Furthermore, the terms "first," "second," and the like are used merely to distinguish one description from another, and are not to be construed as indicating or implying relative importance.

In the description of the present application, it should also be noted that, unless expressly stated or limited otherwise, the terms "disposed" and "connected" are to be construed broadly, and may for example be fixedly connected, detachably connected, or integrally connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present application can be understood in a specific case by those of ordinary skill in the art.

Referring to fig. 1-4 in combination with fig. 5, the wrapping-type cutting balloon of the present application mainly wraps the cutting blades 2 and the medicine coated on the balloon surface or on the cutting blades 2 by changing the structure of the cutting balloon itself, and improves the cutting effect of the cutting blades 2 on the lesion 71 in the blood vessel 7 by changing the state change of the existing cutting balloon during the deformation process.

The wrapping type cutting saccule is accommodated in the catheter 3 in a compressed state in the conveying process, the catheter 3 and the cutting saccule are conveyed to the proximal end of a lesion part 71 in a blood vessel 7 under the guiding action of the guide wire 6, the cutting saccule is connected to the far end of the push-pull tube 4, after the target part is reached, the push-pull tube 4 is pushed to the far end, the push-pull tube 4 drives the cutting saccule to extend out from the far end opening of the catheter 3, and the pressurizing operation is carried out, so that the cutting blade 2 cuts the lesion part 71, and meanwhile, the medicine acts on the lesion part 71.

Referring to fig. 1-4, the wrapping type cutting balloon in the present application mainly includes a balloon body 1, a plurality of balloon segments 11 that can be pressurized to turn outward or be depressurized to turn back are disposed on the balloon body 1, a cutting blade 2 is interposed between adjacent balloon segments 11, and the cutting blade 2 is connected to the cutting balloon.

The cutting blades 2 can be coated on the surface of the balloon between the adjacent balloon flaps 11 before the balloon is pressurized, and the outer surfaces of the cutting blades 2 and/or the cutting balloon are coated with medicine, so that the balloon body 1 before the pressurization deformation can simultaneously coat the medicine and the cutting blades 2.

This application is through the even medicine that coats in the parcel position on sacculus body 1 surface, also can evenly scribble the medicine simultaneously on cutting blade 2 to make cutting blade 2 at the pathological change position 71 of cutting, and exert the medicine to pathological change position 71 at the sacculus outer surface that cutting sacculus is located cutting blade 2 root both sides, in order to reach the technical purpose who fully applys medicine to pathological change position 71.

The crease 12 that combines to set up on cutting the sacculus can make sacculus lamella 11 use crease 12 to guide and inflate the evagination or the pressure release is turned back, makes cutting the sacculus along crease 12 and carry out the inflation of the same deformation orbit and receive and withdraw flatly to keep the knife face of cutting blade 2 in the footpath of sacculus, thereby can wrap up cutting blade 2 in the cutting sacculus after the shrink reliably, and then conveniently pull back the cutting sacculus after the shrink into in pipe 3.

In the shape transformation of the cutting saccule during pressurization, the installation part of the cutting blade 2 is taken as the center, the saccule surfaces at the two sides of the cutting blade 2 are outwards unfolded, on one hand, the cutting blade 2 is outwards moved along the radial direction of the saccule, the cutting edge 22 part of the cutting blade 2 effectively cuts in the depth direction of a lesion part 71, on the other hand, the medicine on the cutting blade acts on the lesion part 71, on the other hand, the medicine attached to the coating part can also act on the lesion part 71 at the two sides of the root part of the cutting blade 2, and the medicine is fully and completely applied.

Through the wrapping type cutting balloon, the cutting blade 2 can be close to or far away from a part to be cut on the inner wall of the blood vessel 7 in the radial direction of the cutting balloon, so that the cutting blade 2 can fully apply cutting force on a lesion part 71, a larger cutting depth is achieved, and the cutting effect is improved.

In one specific embodiment, the balloon flaps 11 are uniformly arranged in the radial direction of the cutting balloon, so that the balloon flaps 11 can be deformed in the radial direction to avoid rotation around the axis of the balloon, and the cutting blades 2 can reliably move in the radial direction of the cutting balloon along with the deformation of the balloon along the folds 12.

Preferably, in order to reduce the gap space between the balloon petals 11 after the balloon is deformed so that the cutting blades 2 can more fully contact the lesion 71, the number of the balloon petals 11 is preferably 3 or 5, and the cutting balloon can make the balloon petals 11 appear in a cloverleaf or petal shape on the longitudinal section of the balloon during the deformation process so as to shorten the moving stroke of the cutting blades 2 contacting the lesion 71 and reliably press and cut the lesion 71.

In order to ensure the stable reliability of the installation of the cutting blade 2 on the balloon, a groove for installing the cutting blade 2 is arranged on the outer side wall of the cutting balloon, and through the arrangement mode, on one hand, the cutting blade 2 can be stably connected on the cutting balloon, on the other hand, the cutting blade 2 can convert the expansion force generated by the deformation of the balloon into the pushing force output to the cutting blade 2 on the basis of the balloon body 1, so that the cutting blade 2 can fully and reliably cut the lesion part 71.

With reference to fig. 4, further, the cutting blade 2 includes a blade seat 21 and a blade 22, the blade seat 21 is connected to the outer surface of the cutting balloon, and the length of the blade seat 21 is greater than the length of the blade 22, and the cutting balloon is before being turned outwards by pressurization, specifically, the blade 23 and the blade 22 of the cutting blade 2 are wrapped, so as to prevent the cutting balloon from scratching the catheter 3 during pushing out the catheter 3 and during recycling into the catheter 3.

By setting the length of the tool holder 21 to be longer than the length of the blade edge 22, the root of the cutting blade 2 can be reliably attached to the side wall of the cutting balloon. Further, in order to reliably mount the cutting blade 2 in the groove, protruding blocks 24 are arranged at two ends of the tool apron 21, and the protruding blocks 24 can be in clamping fit with the groove, so that the mounting stability of the cutting blade 2 is ensured.

The cutting sacculus includes conical cylinder section 13 and straight section 14 after the deformation, in order to guarantee that the whole reliable deformation takes place for the cutting sacculus, sacculus lamella 11, cutting blade 2 and crease 12 are run through and are set up on straight section 14, can make the sacculus after the inflation, straight section 14 whole body keeps the deformation state of the expansion of turning up.

The wrapping type cutting saccule can enable the cutting blade 2 to move along the radial direction of the saccule, simultaneously avoid the medicine from being washed and lost in the conveying process, act the medicine on the cutting part during cutting, more fully release the medicine to the pathological change position and play a better treatment effect.

With reference to fig. 5, the wrapped cutting balloon of the present invention is specifically delivered by a balloon catheter system, which includes a catheter 3, a push-pull tube 4 and a cutting balloon. In the using process, the cutting saccule is arranged in the catheter 3, the push-pull tube 4 is connected to the cutting saccule in a penetrating mode, and the catheter 3 is integrally extended into the blood vessel 7, so that the catheter 3 serves as a pushing main body and the cutting saccule and the push-pull tube 4 can be conveyed to a target position in the blood vessel 7.

Specifically, the cutting balloon is connected on push-pull pipe 4, makes push-pull pipe 4 can drive the relative distal end of pipe 3 of cutting balloon flexible around, and then pressurizes inflation and the flat operation of pressure release time. The cutting balloon can be driven to stretch back and forth through the push-pull tube 4, can correspondingly stretch out and draw back for multiple times, and can realize multiple cutting of the lesion part 71 by combining the pressure charging and releasing operation and the deformation of the cutting balloon.

Meanwhile, in the operation process, based on the whole formed by connecting the cutting saccule and the push-pull tube 4, the push-pull tube 4 and the cutting saccule can rotate in the circumferential direction of the blood vessel 7 by rotating the catheter 3, so that the circumferential position of the cutting blade 2 in the blood vessel 7 can be changed, and other lesion parts 71 on the inner wall of the blood vessel 7 can be cut more fully and thoroughly.

In the conveying process, the cutting sacculus under the compression state is accommodated and laid in the catheter 3, and the cutting sacculus is combined with the packages of the cutting blade 2 and the coating medicine, so that the medicine scouring loss is reduced, and the catheter 3 is prevented from being scratched by the cutting blade 2. After deflation, the cutting balloon can re-wrap the cutting blade 2 to facilitate re-pulling the cutting balloon into the catheter 3.

Further, push-and-pull pipe 4 cross-under sets up on the cutting sacculus and stretches out by the distal end of cutting sacculus, is provided with toper connecting block 15 respectively at the both ends of cutting sacculus, through with toper connecting block 15 respectively with push-and-pull pipe 4's outside pipe wall sealing connection, can guarantee that push-and-pull pipe 4 is sealed with the isolated of cutting sacculus inner chamber to make the cutting sacculus can normally carry out the pressurization and the pressure release operation.

It should be noted that the push-pull tube 4 of the present invention includes a pressurizing cavity and a guide wire 6 cavity (both cavities are not shown) which are isolated from each other, and the pressurizing cavity is communicated with the inner cavity of the cutting balloon, so as to ensure that the cutting balloon can be normally inflated and depressurized. The cavity of the guide wire 6 is mainly used for connecting the guide wire 6 in a penetrating way, so that the whole balloon catheter system enters the blood vessel 7 under the guiding action of the guide wire 6 and reaches a target part.

In order to be able to observe the position of the cutting balloon in real time, so that the cutting balloon remains at the lesion 71, the accuracy of the operation process is improved. The push-pull tube 4 is provided with two developing rings 41, and specifically, the two developing rings 41 are respectively arranged on two sides inside the cutting balloon.

Further, in order to observe the relative position relationship between the cutting balloon and the catheter 3, the distal end of the catheter 3 is sleeved with the developing tube 31, and through the three developing points, reference can be provided for a doctor in the operation process, so that the push-pull tube 4 can be pushed and pulled in a targeted manner.

A flexible support ring 5 is arranged between the catheter 3 and the push-pull tube 4, so that on one hand, blood is prevented from leaking out from a gap between the push-pull tube 4 and the catheter 3 when the cutting saccule is not pressurized, and a good sealing effect is achieved; on the other hand, the push-pull tube 4, the cutting balloon and the catheter 3 can be concentrically arranged, and the reliability of the telescopic movement can be maintained.

Specifically, push-and-pull pipe 4 passes whole cutting sacculus, and stretch out from the distal end of cutting sacculus, make cutting sacculus monolithic connection on push-and-pull pipe 4, the polyether block polyamide of harder material is adopted to the push rod pipe, flexible support ring 5 is fixed to be set up in pipe 3, combine the sealed cross-under of push rod pipe to pass through flexible support ring 5, can make the push rod pipe carry out stable push-and-pull operation relative pipe 3, make the pipe 3 that outside-in set gradually, bracing piece and push-and-pull pipe 4 keep the concentric state of reliable relatively, it follows to push-and-pull pipe 4 and carries out the concerted movement to 3 distal end openings of relative pipe to do benefit to the cutting sacculus, especially make the cutting sacculus after the pressure release shrivelled can drag back reliably and get into in the pipe 3.

The balloon catheter system specifically enters a lesion part 71 of a blood vessel 7 under the guiding action of a guide wire 6, the tail end of the guide wire 6 is penetrated through a distal opening of a push-pull tube 4, and the proximal end of the push-pull tube 4 extends out. The whole balloon catheter system can be introduced into the blood vessel 7 through the guiding function of the guide wire 6, reliably reaches the near end of the lesion part 71, and then is pushed out of the catheter 3 to perform subsequent pressurizing cutting operation.

It is important to point out that, by the cutting balloon and balloon catheter system of the present invention, the cutting blades 2 and the coating drug can be wrapped in the balloon during balloon delivery, and the scratching damage to the balloon catheter 3 can be reduced while the drug flow is reduced.

The combination of the deformation states of the balloon inflation eversion and the pressure relief inflection can realize the radial expansion of the cutting blade 2 and the multiple cutting of different pathological tissues in the blood vessel 7, thereby improving the treatment effect to the maximum extent.

It should be noted that the features of the embodiments in the present application may be combined with each other without conflict.

The above description is only a preferred embodiment of the present application and is not intended to limit the present application, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, improvement and the like made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A wrapping type cutting balloon is characterized by comprising a plurality of balloon flaps, wherein cutting blades are clamped between the adjacent balloon flaps and connected to the cutting balloon;

2. The wrap-around cutting balloon of claim 1, wherein the balloon lobes are uniformly distributed in a radial direction of the cutting balloon, and wherein a groove for mounting the cutting blade is provided on an outer sidewall of the cutting balloon.

3. The wrap-around cutting balloon of claim 2, wherein the cutting blade comprises a blade seat and a cutting edge, the blade seat has a length greater than the cutting edge, and protruding blocks snap-fitted into the grooves are provided at both ends of the blade seat.

4. The wrap-around cutting balloon of claim 1, wherein the cutting balloon comprises a deformed cone section and a straight section, and the folds are consecutively disposed on the straight section.

5. A balloon catheter system comprising a catheter, a push-pull tube and a cutting balloon according to any of claims 1-4, said cutting balloon being attached to said push-pull tube, said push-pull tube being capable of driving said cutting balloon to telescope back and forth relative to the distal end of said catheter.

6. The balloon catheter system according to claim 5, wherein the push-pull tube is threaded onto the cutting balloon and extends out of the distal end of the cutting balloon, the cutting balloon includes connecting blocks at two ends, and the connecting blocks are respectively connected with the push-pull tube in a sealing manner.

7. The balloon catheter system according to claim 5, wherein a visualization ring is mounted on the push-pull tube, the visualization ring is disposed in the cutting balloon, and a visualization tube is sleeved on a distal end of the catheter.

8. The balloon catheter system according to claim 5, wherein a flexible support ring is disposed between the push-pull tube and the catheter, the support ring being fixedly disposed in the push-pull tube, the push-pull tube sealingly passing over the support ring.

9. The balloon catheter system according to claim 8, wherein the push-pull tube is made of polyether block polyamide, and the support ring, the catheter and the push-pull tube are concentrically arranged.

10. The balloon catheter system according to claim 5, further comprising a guide wire, wherein a tail end of the guide wire is penetrated by a distal opening of the push-pull tube, and a proximal end of the push-pull tube is extended.