WO2022105065A1

WO2022105065A1 - Bumpy expanding balloon and production and use method therefor

Info

Publication number: WO2022105065A1
Application number: PCT/CN2021/075442
Authority: WO
Inventors: 吴天根; 毕玉影
Original assignee: 东莞天天向上医疗科技有限公司
Priority date: 2020-11-20
Filing date: 2021-02-05
Publication date: 2022-05-27
Also published as: CN112402771B; CN112402771A

Abstract

A bumpy-surface expanding balloon, which is used for dilation treatment of narrow vascular and non-vascular tracts; an outer surface of the bumpy expanding balloon comprises bumps (1) and grooves (2), the bumps (1) and the grooves (2) are continuously (thread-shaped) and/or discontinuously (tread-shaped) uniformly distributed on an outer side of the bumpy expanding balloon. The bumps (1) and the grooves (2) in the bumpy expanding balloon may be integrally formed when a balloon is formed, or may be secondarily formed on a surface of an already formed conventional balloon. When the balloon is expanded, the bumps (1) of the outer surface of the balloon concentrate pressure in the balloon, achieving an effect of high pressure expansion, force borne being uniform, and expansion being safer; a portion of the grooves (2) of the outer surface of the balloon can be loaded with a drug, drug loading capacity can be significantly increased, and drug loss during transportation can be reduced; in a thrombus (15) aspiration catheter, an aspiration effect on the thrombus (15) can be increased; and when a stent (14) is being transported, the balloon can prevent fall-off of the stent (14) during transportation, and safety is increased.

Description

A kind of convex-concave expansion balloon and its production and use method

technical field

The invention relates to the field of balloon catheters, in particular to a convex-concave expansion balloon and a method for producing and using the same.

Background technique

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

Ordinary Balloon Angioplasty (POBA) is a general method for dilating stenosis. The occluded duct is made unobstructed by inflating the balloon at the lesion site. It mainly depends on the shape of the tissue where the balloon is located; for effective dredging, instantaneous high pressure will be generated in some parts during the balloon expansion process. Although the instantaneous high pressure can be temporarily effectively dredged, the transient expansion will cause acute restenosis after surgery. When the punched position is closed after surgery, the surface tension of the tissue site is uneven, which in turn causes tissue damage such as peeling and rupture of the tube wall.

Clinically, when expanding calcified or sclerotic lesions, after stent implantation or drug balloon release, a high-pressure balloon (higher than 20 bar, or even higher, is usually required to implant the stent or drug into the blood vessel). ). Once the high-pressure balloon ruptures, it will cause patient death or other sequelae. To solve this problem,

At present, in clinical practice, either a metal wire or a metal knife is fixed on the outside of the balloon (for example, US10117668, etc.), or several vertical or horizontal ridges (spinous process balloon or chocolate balloon) are bound on the surface of ordinary balloons to prevent low pressure The effect of cutting and expansion can be achieved at the same time, preventing balloon expansion from causing tearing at the lesion. However, the instantaneous state of dispersal of the metal wire or the metal knife is affected by the balloon expansion. The instantaneous expansion of the balloon may cause the metal wire or the metal knife to tear or penetrate the surrounding blood vessel wall, affecting the normal operation of the subsequent operation.

At the same time, the balloons of the existing balloon catheters in clinical use all have smooth surfaces, and at the bifurcation or bend of the blood vessel, when the tissue is too soft (atheroma) or too hard (calcification), the balloon slides and cannot be effectively expanded.

In the process of angioplasty, some therapeutic drugs are usually wrapped in the balloon catheter. When the balloon is expanded, the drug will be released to the lesion, but the surface of the balloon in the catheter is relatively smooth, and the blood is passed through the catheter and the balloon. The process of entering the lesion will lead to the loss of the therapeutic drug, thereby making the utilization rate of the drug low.

Stent and valve implantation are currently widely used treatment methods. During implantation, the stent or valve is first crimped to the surface of the balloon and then delivered to the diseased area. How to prevent the stent from falling off during the delivery of the stent or valve is also a problem to be solved urgently at present.

Thrombus aspiration is also the main method for the treatment of intravascular thrombus. At present, suction catheters or suction plug stents are mainly used. The suction catheter is to suction the thrombus through a catheter with negative pressure, and the effect is not ideal. The thrombectomy stent is a metal stent that is fixed to the end of the catheter. The stent self-expands at the thrombus position and hooks the thrombus tissue. Clinical use is complicated and expensive.

SUMMARY OF THE INVENTION

In view of the deficiencies of the prior art, the purpose of the present invention is to provide a convex-concave dilation balloon and its production and use method.

In order to achieve the above purpose, the present invention adopts the following technical scheme: a convex-concave-shaped expansion balloon, the outer surface of the convex-concave-shaped expansion balloon includes protrusions and grooves, and the protrusions and grooves are evenly distributed in the convex-concave shape. outside of the expansion balloon;

The convex-concave expansion balloon further comprises connecting parts located at both ends of the convex-concave expansion balloon, the convex-concave expansion balloon is connected to the catheter through the connection parts at both ends, and the convex-concave expansion balloon includes an expansion port inside, so The expansion port is connected to the inflator pump located outside the catheter through the inner channel of the catheter.

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

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

S01: Prepare a convex-concave balloon mold, the inner wall of the convex-concave balloon mold includes mold protrusions and mold grooves that have the same shape as the outer surface of the convex-concave expansion balloon, and both ends of the convex-concave balloon mold include mold connecting parts ;

S02: Prepare a convex-concave expansion balloon in a convex-concave balloon mold; during the thermal blow molding process, the mold protrusions and mold grooves form grooves and protrusions on the outer surface of the convex-concave expansion balloon, and the molds are connected The part forms a connecting part between the two ends of the convex and concave expansion balloon.

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

S01: use a cylindrical balloon mold and a blow molding process to prepare a cylindrical expansion balloon;

S02: Welding the same or different thermoplastic polymer filaments on the surface of the cylindrical balloon to form a convex-concave expansion balloon; the position of the thermoplastic polymer filament is a convex surface of the convex-concave expansion balloon.

S02: Laser engraving or chemical ablation is used to form a convex-concave expansion balloon on the surface of the cylindrical balloon; the grooves on the surface of the convex-concave expansion balloon are formed at the location of the engraving or ablation.

A method for using a convex-concave dilation balloon, comprising the following steps:

S01: The convex and concave dilation balloon is folded by the balloon folding technology, so that the convex and concave dilation balloon is folded around the outside of the catheter;

S02: The catheter containing the convex-concave dilation balloon enters a designated position in the human body, and the convex-concave dilation balloon is inflated;

S03: The convex-concave-shaped expansion balloon is punched and expanded, and the protrusions located on the outside of the convex-concave-shaped expansion balloon cause the human tissue to be stretched evenly by force.

Further, in the step S01, the medicine is first stored in the groove on the outside of the convex-concave expansion balloon, and then the convex-concave expansion balloon is folded;

In the step S03, when the convex and concave expansion balloon is expanded, the medicine in the groove is released.

Further, in the step S01, the stent is firstly pressed against the outer side of the convex-concave expansion balloon, and the stent is released when the convex-concave expansion balloon is expanded in the step S03.

S02: The catheter containing the convex-concave dilation balloon enters the place where there is a thrombus in the blood vessel, and inflates the convex-concave dilation balloon;

S03: When the convex-concave expansion balloon is punched and expanded, the thrombus is pressed against the groove part of the convex-concave expansion balloon, the convex-concave expansion balloon is suctioned by negative pressure, the convex part clamps the thrombus, and the thrombus tissue is returned to the thrombus. out.

The convex and concave expansion balloon of the present invention is manufactured by a one-time molding process, and the beneficial effects of the present invention are: the manufacturing process of the present invention is simple and efficient; the process can also accurately control the shape and number of the convex and concave grooves, so as to ensure the expansion of the convex and concave expansion balloon When the balloon is expanded, the protrusion on the outer surface of the balloon concentrates the pressure in the balloon to achieve the effect of high-pressure expansion, and the force is uniform, and the expansion is safer; the groove part of the outer surface of the balloon of the present invention can be loaded with drugs , in the drug expansion balloon catheter, the loading of the drug can be significantly increased, and the loss of the drug during the delivery process can be reduced; in the thrombus suction catheter, the thrombus suction effect can be increased. The grooves and protrusions on the outer surface of the balloon of the present invention can significantly increase the friction between the stent and the surface of the balloon when the stent is transported, and reduce the falling off of the stent during the delivery process. The calcified lesion area is not easy to slip, and it is safer to use.

Description of drawings

1 is a schematic structural diagram of a convex-concave dilation balloon comprising a threaded protrusion and a threaded groove in Example 1;

2 is a schematic structural diagram of a crawler-shaped convex-concave expansion balloon in Example 1;

3 is a schematic structural diagram of the discontinuous convex-concave dilation balloon in Example 1;

Accompanying drawing 4 is the structure schematic diagram of continuous convex-concave expansion balloon thermal blow molding preparation mold;

Accompanying drawing 5 is the actual picture of the concave-convex dilation balloon prepared by the hot blow molding preparation method;

6 is a schematic diagram of the convex-concave dilation balloon in Example 1 when the blood vessel is dilated.

Reference numerals: 1 convex, 2 groove, 3 connecting part, 4 left fixed end, 5 right fixed end, 6 catheter, 7 mold cavity, 8 mold end, 9 lesion, 10 vessel wall; 13 drug, 14 stent , 15 thrombus.

Detailed ways

Below, in conjunction with accompanying drawing and specific embodiment, the present invention is further described:

The invention provides a convex-concave expansion balloon, the outer surface of which includes protrusions and grooves, and the protrusions and grooves are evenly distributed on the outside of the convex-concave expansion balloon. In the present invention, the adjacent protrusions on the outside of the balloon are the grooves; the protrusions and grooves can be, but are not limited to, helical protrusions and helical grooves, spherical protrusions and spherical grooves, or any surface with an arc the protrusions and the grooves between the protrusions. The present invention can set the distance between the protrusions to be 1-99 mm, the height of the protrusions and/or the depth of the grooves to be 0.1-20 mm, and the angle between the protrusions and the axis of the balloon to be 1-90 degrees.

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

Example 1

As shown in Figure 1, the protrusions and grooves on the outside of the convex-concave expansion balloon are spiral protrusions and spiral grooves; the two ends of the convex-concave expansion balloon are connecting parts 3, and the connecting parts 3 on both sides are respectively fixed by the left The end 4 and the right fixed end 5 are fixedly connected to the conduit 6 . The convex-concave expansion balloon includes an expansion port, and the expansion port is connected to the inflator located outside the catheter through the inner channel of the catheter; when the convex-concave expansion balloon needs to be expanded, the inflatable pump inflates the convex-concave expansion balloon through the expansion port, so that the convex-concave expansion balloon is inflated. Inflated balloon. The outer diameter of the convex and concave expansion balloon is larger than the outer diameter of other parts of the catheter in the inflated state. The outer diameter of the convex and concave expansion balloon can be expanded to different diameters under different inflation pressures, which is used for stenosis or blockage in the human body. Partially expanded. The convex-concave dilation balloon catheter of the present invention may be an OTW (over the wire balloon) double-lumen balloon catheter or an RX (rapid exchange) rapid exchange balloon catheter or other balloon catheters used in dilation therapy.

In actual use, the position and number of the expansion ports in the balloon can be set according to specific requirements. Balloon materials may include but are not limited to nylon and its copolymers, PET (polyethylene terephthalate, polyethylene terephthalate), PEBAX (polyether block polyamide) and one of other polymers or copolymers . The convex and concave expansion balloon can be inflated from 0.11 to 40 atmospheres of pressure, while the convex and concave expansion balloon can have a rated burst pressure range of 1 to 50 atmospheres. The specific inflation pressure range and rated burst range depend on the balloon. Materials, dimensions and wall thicknesses.

Please continue to refer to FIG. 1, in the present invention, the thread grooves and thread protrusions in the same plane can be set to be parallel to each other, and the included angles between all the thread grooves and thread protrusions and the axis of the convex and concave expansion balloon are equal; Specifically, the included angle between the threaded groove and the threaded protrusion and the axis of the convex-concave expansion balloon can be set to be greater than or equal to 5 degrees and less than 90 degrees; forming a uniform spiral pattern outside the convex-concave expansion balloon. In the present invention, the distance between the two thread protrusions of the convex-concave dilation balloon is 0.1-100 mm.

The thread on the outer side of the convex-concave dilation balloon can also ensure that the balloon is accurately expanded at the lesion, avoiding the smooth balloon surface from slipping at the lesion, thereby improving the positioning performance of the convex-concave dilatation balloon catheter on the lesion.

Example 2

As shown in FIG. 2 , the protrusions 1 and grooves 2 on the outside of the convex-concave expansion balloon are plane protrusions and spherical grooves; wherein, plane protrusions are formed between adjacent spherical grooves. In this embodiment, the position of the convex and concave dilation balloon in the catheter is the same as that of the embodiment, and the material and function of the convex and concave dilation balloon are the same as those of the embodiment, which will not be described in detail here.

Example 3

As shown in FIG. 3 , the protrusions 1 and grooves 2 on the outside of the convex-concave expansion balloon are spherical protrusions and flat grooves; wherein, plane grooves are formed between adjacent spherical protrusions. In this embodiment, the position of the convex and concave dilation balloon in the catheter is the same as that of the embodiment, and the material and function of the convex and concave dilation balloon are the same as those of the embodiment, which will not be described in detail here.

Example 4

The preparation method of a convex-concave dilation balloon provided in this embodiment includes the following steps:

S01: Prepare a convex-concave balloon mold, the inner wall of the convex-concave balloon mold contains mold protrusions and mold grooves with the same shape as the outer surface of the convex-concave expansion balloon, and both ends of the convex-concave balloon mold include mold connecting parts. The specific shape of the balloon mold is determined according to the shape of the target balloon, the mold protrusions in the balloon mold correspond to the grooves in the balloon, and the mold grooves in the balloon mold correspond to the protrusions in the balloon. 4 is a schematic diagram of the structure of the helical balloon after molding in the mold; the thread protrusion 1 in the balloon corresponds to the mold groove in the mold cavity 7, and the thread groove 2 in the balloon corresponds to the mold cavity 7. The mold is convex, and the connecting parts 3 at both ends of the balloon correspond to the connecting parts of the mold in the mold.

S02: Prepare a convex-concave expansion balloon in a convex-concave balloon mold; during the thermoplastic molding process, the mold protrusions and mold grooves form grooves and protrusions on the outer surface of the convex-concave expansion balloon, and the mold connection portion forms convex-concave The connecting parts at both ends of the balloon-shaped expansion balloon. The structure of the prepared convex-concave expansion balloon is shown in FIG. 5 .

Example 5

A method for preparing a convex-concave dilatation balloon, comprising the following steps:

S01: use a cylindrical balloon mold and a blow molding process to prepare a cylindrical balloon; any cylindrical balloon mold and blow molding process in the prior art can be used to prepare a cylindrical balloon;

S02: Weld the same or different thermoplastic polymer filaments on the surface of the cylindrical balloon to form a convex-concave expansion balloon; the thermoplastic polymer filaments are located at the convex-concave expansion balloon surface and are adjacent to the convex. grooves are formed between them.

Example 6

Another method for preparing a convex-concave dilation balloon provided in this embodiment includes the following steps:

S02: Use laser engraving or chemical ablation to form a convex-concave expansion balloon on the surface of the cylindrical balloon; form a convex-concave expansion balloon surface groove at the location where the engraving or ablation is located.

Example 7

S01: First store the drug in the groove on the outside of the convex-concave expansion balloon, and then use the balloon folding technology to fold the convex-concave expansion balloon, so that the convex-concave expansion balloon is a folded shape wrapped around the outside of the catheter.

The therapeutic drugs can be, but are not limited to, antiproliferative agents and anticoagulants; in addition to drugs, iodine, urea, etc. can also be encapsulated in the balloon.

S02: The catheter containing the convex-concave dilation balloon enters a designated position in the human body, and inflates the convex-concave dilation balloon;

S03: The convex-concave expansion balloon is expanded, and the bulge located on the outer side of the convex-concave expansion balloon causes the human tissue to be stretched evenly by force, and the medicine in the groove is released.

When the balloon is expanded, the protrusions on the outer surface of the balloon of the present invention concentrate the pressure in the balloon to achieve the effect of high-pressure expansion, and the force is uniform and the expansion is safer. In the present invention, the balloon is not easily slipped in the atheroma and calcified lesions at the blood bifurcation or turning, and is safer to use. The grooves on the outer surface of the balloon in the present invention can be used to store medicines, and when used for carrying medicines, the loss rate of medicines in blood transmission can be reduced. 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 is inflated and inflated, and the bulge moves toward the lesion when the balloon is expanded. 9 Provides high pressure, and since the protrusions are evenly distributed on the outside of the balloon, it can provide uniform punching pressure to the lesion to protect the vessel wall from damage. The medicine 13 stored in the groove is released when the balloon is expanded and filled in the lesion facing the groove, which can not only ensure that the medicine is not lost during the transmission process, but also ensure that the medicine is fully effective at the lesion, further improving Efficacy.

Example 8

A convex-concave dilation balloon can also be used to deliver stents, including the following steps:

S01: First, fix the stent on the outside of the convex-concave expansion balloon. The stent is made of stainless steel, cobalt-chromium alloy, iron alloy or magnesium alloy wire into a cylindrical mesh, which can shrink in the radial direction and is cylindrical in a free state. The stent is crimped and attached to the outside of the convex-concave expansion balloon by the machine and stent crimping process in the prior art;

S03: The convex-concave expansion balloon is expanded, and the bulge located on the outside of the convex-concave expansion balloon causes the human tissue to be stretched evenly by force, the stent is expanded and released, and adheres to the blood vessel wall to support the blood vessel wall. When using the convex-concave expansion balloon of the present invention to deliver the stent, because of the special convex-concave structure on the surface, the stent is less likely to fall off, especially the degradable stent.

Example 9

A convex-concave dilation balloon can be used to clear the thrombus, including the following steps:

S03: When the convex and concave expansion balloon is punched and expanded, the thrombus is pressed against the groove of the convex and concave expansion balloon, the convex and concave expansion balloon is suctioned by negative pressure, the convex part clamps the thrombus, and the thrombus tissue is withdrawn. .

In the present invention, when the balloon is expanded, the bulge on the outer surface of the balloon concentrates the pressure in the balloon to achieve the effect of high-pressure expansion, and the force is uniform and the expansion is safer. In the present invention, the balloon is not easily slipped in the atheroma and calcified lesions at the blood bifurcation or turning, and is safer to use. The grooves on the outer surface of the balloon in the present invention can be used to store medicines, and when used for drug loading, the loss rate of the medicines in blood transmission can be reduced; when the balloon of the present invention is used to deliver the stent, because of the special convex-concave structure on the surface of the present invention , the stent is less likely to fall off, especially the degradable stent. In a thrombus aspiration catheter, the thrombus aspiration effect can be increased. The grooves and protrusions on the outer surface of the balloon of the present invention can significantly increase the friction between the stent and the surface of the balloon during the delivery of the stent, reduce the shedding of the stent during the delivery process, and reduce the detachment of the stent during the delivery process. The calcified lesion area is not easy to slip, and it is safer to use.

For those skilled in the art, various other corresponding changes and deformations can be made according to the technical solutions and concepts described above, and all these changes and deformations should fall within the protection scope of the claims of the present invention.

Claims

A convex-concave-shaped expansion balloon, characterized in that the outer surface of the convex-concave-shaped expansion balloon comprises protrusions and grooves, and the protrusions and grooves are evenly distributed on the outside of the convex-concave-shaped expansion balloon;

The convex-concave expansion balloon further comprises connecting parts located at both ends of the convex-concave expansion balloon, the convex-concave expansion balloon is connected to the catheter through the connection parts at both ends, and the convex-concave expansion balloon includes an expansion port inside, so The expansion port is connected to the inflator pump located outside the catheter through the inner channel of the catheter.
The convex-concave expansion balloon according to claim 1, wherein the protrusions and grooves are continuous threaded protrusions and grooves, or the protrusions and grooves are discontinuous crawler tracks shaped protrusions and crawler-shaped grooves.
A method for preparing a convex-concave dilatation balloon, comprising the following steps:

S01: Prepare a convex-concave balloon mold, the inner wall of the convex-concave balloon mold includes mold protrusions and mold grooves that have the same shape as the outer surface of the convex-concave expansion balloon, and both ends of the convex-concave balloon mold include mold connecting parts ;

S02: Prepare a convex-concave expansion balloon in a convex-concave balloon mold; during the thermal blow molding process, the mold protrusions and mold grooves form grooves and protrusions on the outer surface of the convex-concave expansion balloon, and the molds are connected The part forms a connecting part between the two ends of the convex and concave expansion balloon.
The method for preparing a convex-concave expansion balloon according to claim 3, wherein in the step S02, a convex-concave expansion balloon is formed in a balloon mold by means of thermal injection molding.
A method for preparing a convex-concave dilatation balloon, comprising the following steps:

S01: use a cylindrical balloon mold and a blow molding process to prepare a cylindrical expansion balloon;

S02: Welding the same or different thermoplastic polymer filaments on the surface of the cylindrical balloon to form a convex-concave expansion balloon; the position of the thermoplastic polymer filament is a convex surface of the convex-concave expansion balloon.
A method for preparing a convex-concave dilatation balloon, comprising the following steps:

S01: use a cylindrical balloon mold and a blow molding process to prepare a cylindrical expansion balloon;

S02: Laser engraving or chemical ablation is used to form a convex-concave expansion balloon on the surface of the cylindrical balloon; the grooves on the surface of the convex-concave expansion balloon are formed at the location of the engraving or ablation.
A method of using a convex-concave dilation balloon, comprising the steps of:

S01: The convex and concave dilation balloon is folded by the balloon folding technology, so that the convex and concave dilation balloon is folded around the outside of the catheter;

S02: The catheter containing the convex-concave dilation balloon enters a designated position in the human body, and the convex-concave dilation balloon is inflated;

S03: The convex-concave-shaped expansion balloon is punched and expanded, and the protrusions located on the outside of the convex-concave-shaped expansion balloon cause the human tissue to be stretched evenly by force.
The method for using a convex-concave dilation balloon according to claim 7, wherein in the step S01, the medicine is first stored in the groove outside the convex-concave dilation balloon, and then the convex-concave dilation balloon is stored to fold;

In the step S03, when the convex and concave expansion balloon is expanded, the medicine in the groove is released.
A method of using a convex-concave expansion balloon according to claim 7, wherein in the step S01, the stent is firstly pressed on the outside of the convex-concave expansion balloon, and in the step S03, the convex-concave expansion balloon is During expansion, the stent is released.
A method of using a convex-concave dilation balloon, comprising the steps of:

S01: The convex and concave dilation balloon is folded by the balloon folding technology, so that the convex and concave dilation balloon is folded around the outside of the catheter;

S02: the catheter containing the convex-concave dilation balloon enters the place where there is a thrombus in the blood vessel, and inflates the convex-concave dilation balloon;

S03: When the convex-concave expansion balloon is punched and expanded, the thrombus is pressed against the groove part of the convex-concave expansion balloon, the convex-concave expansion balloon is suctioned by negative pressure, the convex part clamps the thrombus, and the thrombus tissue is withdrawn .