CN112402771B

CN112402771B - Convex-concave expansion balloon and production and use method thereof

Info

Publication number: CN112402771B
Application number: CN202011311210.4A
Authority: CN
Inventors: 吴天根; 毕玉影
Original assignee: Dongguan Tiantianxiangshang Medical Technology Co ltd
Current assignee: Dongguan Tiantianxiangshang Medical Technology Co ltd
Priority date: 2020-11-20
Filing date: 2020-11-20
Publication date: 2021-10-08
Anticipated expiration: 2040-11-20
Also published as: CN112402771A; WO2022105065A1

Abstract

The invention discloses a surface convex-concave expansion balloon, which is used for the expansion treatment of vascular and non-vascular duct stenosis; the outer surface of the convex-concave expansion saccule comprises bulges and grooves which are distributed on the outer side of the convex-concave expansion saccule in a continuous (threaded) and/or discontinuous (caterpillar) shape. The bulges and the grooves in the convex-concave expansion saccule can be integrally formed during the forming of the saccule or can be formed on the surface of the formed traditional saccule in a secondary forming mode. When the saccule is expanded, the bulges on the outer surface of the saccule concentrate the pressure in the saccule, so that the high-pressure expansion effect is achieved, the stress is uniform, and the expansion is safer; the groove part on the outer surface of the balloon can be loaded with drugs, so that the loading capacity of the drugs can be obviously increased, and the loss of the drugs in the conveying process can be reduced; in the thrombus aspiration catheter, the thrombus aspiration effect can be increased; the balloon can avoid falling off in the stent conveying process when the stent is conveyed, and is safer to use.

Description

Convex-concave expansion balloon and production and use method thereof

Technical Field

The invention relates to the field of balloon catheters, in particular to a convex-concave expansion balloon and a production and use method thereof.

Background

Balloon dilatation (angioplasty) is a common treatment used mainly for the dilatation reconstruction of stenosed sites of vascular or non-vascular ducts. The balloon is inflated at the stenosis to apply radial pressure to the inner wall of the tube and widen the stenosis area for better blood flow.

Common balloon angioplasty (POBA) is a common method for dilating strictures, in which a balloon at a lesion site is inflated to open an occluded tract, but the inflation force applied to various parts of a human tissue in the process of balloon inflation is uncontrollable and mainly depends on the shape of the tissue at the site where the balloon is located; in order to effectively dredge, instantaneous high pressure can be generated at certain parts in the process of balloon expansion, although the instantaneous high pressure can temporarily and effectively dredge, the transient expansion can cause acute restenosis after operation, and the flushed position causes uneven surface tension of the tissue part when closed after the operation, thereby causing tissue damage such as tube wall stripping, rupture and the like.

Clinically, a high pressure balloon (above 20bar, or even higher) is often required for stent or drug implantation into the vessel after stent implantation, or after drug balloon release, when performing dilatation calcification or sclerosis of the lesion. Once the high pressure balloon is ruptured, death or other sequelae of the patient can result. In order to solve this problem,

at present, clinically, a metal wire or a metal knife is fixed on the outer side of the balloon (for example, US10117668 quilt, etc.), or a plurality of longitudinal ridges or transverse ridges (a spinous process balloon or a chocolate balloon) are bound on the surface of a common balloon so as to achieve the effect of cutting and expanding at low pressure, so that the balloon is prevented from tearing at a focus. However, the instant state of the scattering of the metal wire or the metal knife is affected by the balloon expansion, and the instant expansion of the balloon may cause the metal wire or the metal knife to tear or penetrate the surrounding blood vessel wall, which affects the normal operation of the subsequent operation.

Meanwhile, balloons of the existing balloon catheter in clinical use are all smooth surfaces, and the balloons slide when tissues are too soft (atheroma) or too hard (calcification) at the bifurcation or corner of a blood vessel, so that effective expansion cannot be carried out.

In the angioplasty process, some therapeutic drugs are usually wrapped in a balloon catheter, when the balloon is expanded, the drugs are released to a focus, but the surface of the balloon in the catheter is smooth, so that the therapeutic drugs are lost in the process that the catheter and the balloon enter the focus through blood, and the utilization rate of the drugs is low.

The stent and valve implantation is a widely adopted treatment method at present, and when the stent or valve is implanted, the stent or valve is firstly pressed on the surface of a balloon and then delivered to a diseased region. How to avoid the problem that the stent does not fall off in the process of delivering the stent or the valve is also the problem solved by the existing urgent belt.

Thrombus aspiration techniques are also currently the primary method of treating intravascular thrombi. Suction catheters or suction plug holders are mainly used at present. The suction catheter sucks thrombus through one catheter under negative pressure, and the effect is not ideal. The thrombus extraction stent is characterized in that a metal stent is fixed at the tail end of a catheter, the stent self-expands at the thrombus position to hook thrombus tissues, and the thrombus extraction stent is complex in clinical use and expensive in cost.

Disclosure of Invention

Aiming at the defects of the prior art, the invention aims to provide a convex-concave expansion balloon and a production and use method thereof.

In order to achieve the purpose, the invention adopts the following technical scheme: the convex-concave expansion balloon comprises bulges and grooves, wherein the bulges and the grooves are uniformly distributed on the outer side of the convex-concave expansion balloon;

the convex-concave expansion balloon further comprises connecting parts which are arranged at two ends of the convex-concave expansion balloon, the convex-concave expansion balloon is connected into the catheter through the connecting parts at the two ends, the convex-concave expansion balloon comprises an expansion air port inside, and the expansion air port is connected with an inflator pump which is arranged on the outer side of the catheter through an internal channel of the catheter.

Further, the protrusions and the grooves are continuous thread protrusions and thread grooves, or the protrusions and the grooves are discontinuous crawler-shaped protrusions and crawler-shaped grooves.

A preparation method of a convex-concave expansion balloon comprises the following steps:

s01: preparing a convex-concave balloon mold, wherein the inner wall of the convex-concave balloon mold comprises a mold bulge and a mold groove which have the same shape as the outer surface of the convex-concave expansion balloon, and two ends of the convex-concave balloon mold comprise mold connecting parts;

s02: preparing a convex-concave expansion balloon in a convex-concave balloon mold; in the hot blow molding process, the mold bulge and the mold groove form a groove and a bulge on the outer surface of the convex-concave expansion balloon, and the mold connecting part forms connecting parts at two ends of the convex-concave expansion balloon.

Further, in step S02, a convex-concave expansion balloon is formed in the balloon mold by using a thermal injection molding method.

s01: preparing a cylindrical expansion balloon by adopting a cylindrical balloon mold and a blow molding process;

s02: welding the same or different thermoplastic polymer material filaments on the surface of the cylindrical balloon to form a convex-concave expansion balloon; the thermoplastic polymer material filaments are convex on the surface of the convex-concave expansion balloon.

s02: forming a convex-concave expansion balloon on the surface of the cylindrical balloon by using a laser engraving or chemical ablation method; the carving or ablation part forms a concave-convex expansion balloon surface groove.

A use method of a convex-concave expansion balloon comprises the following steps:

s01: folding the convex-concave expansion saccule by adopting a saccule folding technology to enable the convex-concave expansion saccule to be in a fold shape wound on the outer side of the catheter;

s02: a catheter comprising a convex-concave expansion balloon enters a specified position of a human body, and the convex-concave expansion balloon is inflated;

s03: the convex-concave expansion saccule is punched and expanded, and the bulges positioned on the outer side of the convex-concave expansion saccule ensure that human tissues are uniformly stressed and expanded.

Further, in step S01, the drug is first stored in the groove on the outer side of the convex-concave type dilatation balloon, and then the convex-concave type dilatation balloon is folded;

when the concave-convex dilatation balloon is expanded in the step S03, the medicine in the groove is released.

Further, the stent is first crimped outside the convex-concave dilatation balloon in step S01, and the stent is released when the convex-concave dilatation balloon is expanded in step S03.

s02: a catheter comprising a convex-concave expansion balloon enters a position with thrombus in a blood vessel and inflates the convex-concave expansion balloon;

s03: when the convex-concave expansion saccule is punched and expanded, thrombus is pressed on the groove part of the convex-concave expansion saccule, the convex-concave expansion saccule is sucked under negative pressure, and the thrombus is clamped by the convex part to suck thrombus out.

The convex-concave expansion balloon is manufactured by adopting a one-step forming process, and the convex-concave expansion balloon has the beneficial effects that: the preparation process is simple and efficient; the process can also accurately control the shapes and the number of the bulges and the grooves, ensure that when the convex-concave expansion balloon is expanded, the bulges on the outer surface of the balloon concentrate the pressure in the balloon when the balloon is expanded, achieve the effect of high-pressure expansion, and have uniform stress and safer expansion; the groove part on the outer surface of the balloon can be loaded with drugs, so that the drug loading capacity can be obviously increased in the drug expansion balloon catheter, and the loss of the drugs in the delivery process can be reduced; in the thrombus aspiration catheter, the thrombus aspiration effect can be increased. The grooves and the bulges on the outer surface of the balloon can obviously increase the friction force between the stent and the surface of the balloon during stent delivery, reduce the falling off of the stent during the delivery process, are not easy to slip in atheromatous lesion and calcified lesion areas at blood forks or corners, and are safer to use.

Drawings

FIG. 1 is a schematic structural view of a convex-concave type dilatation balloon comprising a thread protrusion and a thread groove in example 1;

FIG. 2 is a schematic structural view of the balloon of example 1 including a track-shaped concave-convex type dilatation balloon;

FIG. 3 is a schematic structural view of the discontinuous concave-convex dilatation balloon of example 1;

FIG. 4 is a schematic structural view of a mold for preparing a continuous convex-concave expansion balloon by hot blow molding;

FIG. 5 is a diagram of a concave-convex dilatation balloon material object prepared by the hot blow molding preparation method;

fig. 6 is a schematic view of the concave-convex dilatation balloon in example 1 when the blood vessel is dilated.

Reference numerals: 1 bulge, 2 grooves, 3 connecting parts, 4 left fixed ends, 5 right fixed ends, 6 catheters, 7 mold cavities, 8 mold ends, 9 lesion positions and 10 vessel walls; 13 drugs, 14 stents, 15 thrombi.

Detailed Description

The invention will be further described with reference to the accompanying drawings and the detailed description below:

the invention provides a convex-concave expansion balloon, the outer surface of which comprises bulges and grooves, and the bulges and the grooves are uniformly distributed on the outer side of the convex-concave expansion balloon. In the invention, a groove is formed between adjacent bulges outside the saccule; the protrusions and grooves may be, but are not limited to, spiral protrusions and spiral grooves, spherical protrusions and spherical grooves, or protrusions with curvature on any surface and grooves between protrusions. The invention can set the distance between the bulges to be 1-99mm, the height of the bulges and/or the depth of the grooves to be 0.1-20mm, and the included angle between the axial leads of the bulges and the saccule to be 1-90 degrees.

The shape of the balloon of the invention is described below by way of example by the different shapes of the protrusions and grooves in example 1:

example 1

As shown in fig. 1, the bulges and the grooves on the outer side of the convex-concave expansion balloon are spiral bulges and spiral grooves; two ends of the convex-concave expansion saccule are provided with connecting parts 3, and the connecting parts 3 at two sides are respectively fixedly connected on a catheter 6 through a left fixing end 4 and a right fixing end 5. The concave-convex expansion saccule comprises an expansion air port inside, and the expansion air port is connected with an inflator pump positioned outside the catheter through an internal channel of the catheter; when the convex-concave expansion saccule needs to be expanded, the inflation pump inflates the convex-concave expansion saccule through the expansion air port to enable the convex-concave expansion saccule to be expanded. The outer diameter of the convex-concave expansion saccule is larger than that of other parts of the catheter in an inflated state, and the outer diameter of the convex-concave expansion saccule can be expanded into different outer diameters under different inflation pressures so as to be used for expanding narrow or blocked parts in a human body. The convex-concave expansion balloon catheter in the invention can be an OTW (over the wire balloon) double-cavity balloon catheter or an RX (rapid exchange) rapid exchange balloon catheter or other balloon catheters applied to expansion treatment.

In practical use, the positions and the number of the expansion air ports in the balloon can be set according to specific requirements. The balloon material may include, but is not limited to, one of nylon and its copolymers, PET (polyethylene terephthalate), PEBAX (polyether block polyamide), and other polymers or copolymers. The pressure range for inflating the convex-concave expansion balloon can be 0.11 to 40 atmospheres, and the rated bursting pressure range of the convex-concave expansion balloon can be 1 to 50 atmospheres, and the specific inflation pressure range and the rated bursting range depend on the material, the size and the wall thickness of the balloon.

With reference to fig. 1, the thread grooves and the thread protrusions in the same plane may be parallel to each other, and the included angles between all the thread grooves and the thread protrusions and the axis of the convex-concave expansion balloon are equal; specifically, the included angle between the thread groove and the thread bulge and the axis of the convex-concave expansion balloon can be more than or equal to 5 degrees and less than 90 degrees; forming a uniform spiral pattern outside the convex-concave dilatation balloon. The distance between the two thread bulges of the convex-concave expansion saccule is 0.1-100 mm.

The thread on the outer side of the convex-concave expansion balloon can ensure that the balloon position can be accurately expanded at the focus, so that the smooth balloon surface is prevented from slipping at the focus, and the positioning performance of the convex-concave expansion balloon catheter on the focus is further improved.

Example 2

As shown in figure 2, the bulges 1 and the grooves 2 on the outer side of the convex-concave expansion balloon are plane bulges and spherical grooves; wherein, a plane bulge is formed between the adjacent spherical grooves. In this embodiment, the position of the concave-convex dilatation balloon in the catheter is the same as that of the embodiment, and the material and the efficacy of the concave-convex dilatation balloon are the same as those of the embodiment, which will not be described in detail herein.

Example 3

As shown in figure 3, the bulges 1 and the grooves 2 on the outer side of the convex-concave expansion balloon are spherical bulges and plane grooves; wherein, a plane groove is formed between the adjacent spherical bulges. In this embodiment, the position of the concave-convex dilatation balloon in the catheter is the same as that of the embodiment, and the material and the efficacy of the concave-convex dilatation balloon are the same as those of the embodiment, which will not be described in detail herein.

Example 4

The preparation method of the convex-concave expansion balloon provided by the embodiment comprises the following steps:

s01: preparing a convex-concave balloon mold, wherein the inner wall of the convex-concave balloon mold comprises a mold bulge and a mold groove which have the same shape as the outer surface of the convex-concave expansion balloon, and two ends of the convex-concave balloon mold comprise mold connecting parts. The specific shape of the balloon mold is determined according to the shape of a target balloon, the mold bulge in the balloon mold corresponds to the groove in the balloon, and the mold groove in the balloon mold corresponds to the bulge in the balloon. FIG. 4 is a schematic structural diagram of the spiral balloon after being molded in a mold; the thread bulge 1 in the sacculus corresponds to the mould groove in the mould cavity 7, the thread groove 2 in the sacculus corresponds to the mould bulge in the mould cavity 7, and the connecting parts 3 at the two ends of the sacculus correspond to the mould connecting parts in the mould.

S02: preparing a convex-concave expansion balloon in a convex-concave balloon mold; in the thermoplastic molding process, the mold bulge and the mold groove form a groove and a bulge on the outer surface of the convex-concave expansion balloon, and the mold connecting part forms connecting parts at two ends of the convex-concave expansion balloon. The structure of the prepared convex-concave expansion balloon is shown in figure 5.

Example 5

The preparation method of the convex-concave expansion balloon is characterized by comprising the following steps:

s01: preparing a cylindrical balloon by adopting a cylindrical balloon mold and a blow molding process; the cylindrical balloon can be prepared by adopting any cylindrical balloon mold and blow molding process in the prior art;

s02: welding the same or different thermoplastic polymer material filaments on the surface of the cylindrical balloon to form a convex-concave expansion balloon; the thermoplastic polymer material filaments are arranged at the convex-concave surface bulges of the expansion balloon, and grooves are formed between the adjacent bulges.

Example 6

s02: forming a convex-concave expansion balloon on the surface of the cylindrical balloon by using a laser engraving or chemical ablation method; the carving or the ablation is carried out to form a concave-convex expansion balloon surface groove.

Example 7

s01: the medicine is stored in the groove on the outer side of the convex-concave expansion balloon, and then the convex-concave expansion balloon is folded by adopting a balloon folding technology, so that the convex-concave expansion balloon is in a corrugated shape wound on the outer side of the catheter.

Therapeutic agents may be, but are not limited to, antiproliferative agents, anticoagulants; besides the medicine, the balloon can be wrapped with iodine, urea and the like.

S02: the catheter comprising the convex-concave expansion saccule enters a specified position of a human body and inflates the convex-concave expansion saccule;

s03: the convex-concave expansion saccule expands, the bulges positioned at the outer side of the convex-concave expansion saccule ensure that the human tissues are uniformly stressed and expanded, and the medicine in the groove is released.

When the saccule is expanded, the bulges on the outer surface of the saccule concentrate the pressure in the saccule, so that the high-pressure expansion effect is achieved, the stress is uniform, and the expansion is safer. The balloon is positioned at a blood branch or a corner, is not easy to slip in atheromatous lesion and calcified lesion areas, and is safer to use. The groove on the outer surface of the balloon can be used for storing medicines, and the loss rate of the medicines in blood transmission can be reduced when the groove is used for carrying the medicines. Specifically, as shown in fig. 2 and fig. 3, the lesion 9 is located inside the blood vessel, when the balloon moves to the lesion 9 along with the catheter, the spiral balloon inflates, the protrusions provide high pressure to the lesion 9 when the balloon expands, and in view of the fact that the protrusions are uniformly distributed on the outer side of the balloon, uniform pressure can be provided to the lesion, and the blood vessel wall is protected from being damaged. The medicine 13 stored in the groove is released when the saccule expands and is filled in the lesion part opposite to the groove, so that the medicine is not lost in the transmission process, the medicine can be ensured to fully exert the effect at the lesion part, and the medicine effect is further improved.

Example 8

The convex-concave expansion balloon can also be used for conveying a stent, and comprises the following steps:

s01: the stent is fixed on the outer side of the convex-concave expansion saccule, and the stent is made into a cylindrical net shape by weaving stainless steel, cobalt-chromium alloy, iron alloy or magnesium alloy wires, can be contracted along the radial direction and is cylindrical in a free state. The stent is crimped and attached to the outer side of the convex-concave expansion balloon by a machine and a stent crimping process in the prior art;

s03: the convex-concave expansion balloon expands, the bulges positioned outside the convex-concave expansion balloon enable the human tissue to be evenly stressed and propped open, and the stent is expanded and released to be attached to the vessel wall, so that the effect of supporting the vessel wall is achieved. When the convex-concave expansion balloon delivery stent is used, due to the special convex-concave structure of the surface, the stent is not easy to fall off, and particularly the stent can be degraded.

Example 9

A convex-concave expansion balloon can be used for clearing thrombus, and comprises the following steps:

s02: the catheter comprising the convex-concave expansion saccule enters a position with thrombus in a blood vessel and inflates the convex-concave expansion saccule;

s03: when the convex-concave expansion saccule is punched and expanded, thrombus is pressed on the groove part of the convex-concave expansion saccule, the convex-concave expansion saccule is sucked under negative pressure, and the thrombus is clamped by the convex part to withdraw thrombus tissues.

When the balloon is expanded, the bulges on the outer surface of the balloon concentrate the pressure in the balloon, so that the high-pressure expansion effect is achieved, the stress is uniform, and the expansion is safer. The balloon is positioned at a blood branch or a corner, is not easy to slip in atheromatous lesion and calcified lesion areas, and is safer to use. The groove on the outer surface of the balloon can be used for storing medicines, and the loss rate of the medicines in blood transmission can be reduced when the groove is used for carrying the medicines; when the balloon stent is used for conveying, due to the special convex-concave structure on the surface, the stent is not easy to fall off, and particularly the stent can be degraded. In the thrombus aspiration catheter, the thrombus aspiration effect can be increased. The grooves and the bulges on the outer surface of the balloon can obviously increase the friction force between the stent and the surface of the balloon during stent delivery, reduce the falling off of the stent during the delivery process, are not easy to slip in atheromatous lesion and calcified lesion areas at blood forks or corners, and are safer to use.

Various other modifications and changes may be made by those skilled in the art based on the above-described technical solutions and concepts, and all such modifications and changes should fall within the scope of the claims of the present invention.

Claims

1. The convex-concave expansion balloon is characterized in that the outer surface of the convex-concave expansion balloon comprises bulges and grooves, and the bulges and the grooves are uniformly distributed on the outer side of the convex-concave expansion balloon; the protrusions and the grooves are continuous thread protrusions and thread grooves;

the convex-concave expansion balloon also comprises connecting parts positioned at two ends of the convex-concave expansion balloon, the convex-concave expansion balloon is connected into the catheter through the connecting parts at the two ends, the inside of the convex-concave expansion balloon comprises an expansion air port, and the expansion air port is connected with an inflator pump positioned on the outer side of the catheter through an internal channel of the catheter; when the concave-convex expansion saccule is not inflated, the medicine is stored in the groove at the outer side of the concave-convex expansion saccule, so that the medicine loss in the conveying process is reduced; when the concave-convex expansion saccule is punched and expanded, the medicine in the groove is released;

when the convex-concave expansion saccule is not inflated, the convex-concave expansion saccule is folded by adopting a saccule folding technology, so that the convex-concave expansion saccule is in a fold shape wound on the outer side of the catheter; when the convex-concave expansion saccule is punched and expanded, thrombus is pressed on the groove part of the convex-concave expansion saccule, the convex-concave expansion saccule is sucked by negative pressure, and the thrombus is clamped by the convex part to withdraw thrombus tissues.

2. A method for preparing the convex-concave expansion balloon according to claim 1, comprising the steps of:

3. A method for manufacturing a convex-concave expansion balloon according to claim 2, wherein in step S02, the convex-concave expansion balloon is formed in the balloon mold by hot injection.

4. A method for preparing the convex-concave expansion balloon according to claim 1, comprising the steps of:

5. A method for preparing the convex-concave expansion balloon according to claim 1, comprising the steps of: