CN104645487B

CN104645487B - Medical balloon, manufacturing method thereof and balloon dilatation catheter

Info

Publication number: CN104645487B
Application number: CN201310594158.1A
Authority: CN
Inventors: 王婷; 杨海; 奚丽萍; 黄海勇; 刘伟; 唐智荣
Original assignee: Shanghai Microport Medical Group Co Ltd
Current assignee: Shanghai Microport Medical Group Co Ltd
Priority date: 2013-11-21
Filing date: 2013-11-21
Publication date: 2021-06-01
Anticipated expiration: 2033-11-21
Also published as: WO2015074602A1; CN104645487A

Abstract

The invention provides a medical balloon, a manufacturing method thereof and a balloon dilatation catheter, wherein the balloon has a smaller profile diameter after pressure relief, and the invention also aims to ensure that the balloon has better capacity of passing through a lesion part. The medical balloon comprises a balloon conical part and a balloon straight section, wherein a plurality of raised longitudinal ribs are distributed on the balloon straight section at intervals along the circumferential direction. The longitudinal ribs may be formed by applying a band-like coating to the balloon straight section.

Description

Medical balloon, manufacturing method thereof and balloon dilatation catheter

Technical Field

The invention relates to a medical balloon, a manufacturing method thereof and a balloon dilatation catheter.

Background

According to the statistics of the world health organization, chronic diseases such as heart disease and the like become the most main death cause of human beings, accounting for over 60 percent of the total annual death, particularly patients with coronary heart disease. The angioplasty (PCI) is a method for effectively treating various vascular diseases, and is a minimally invasive technique for dredging a diseased vessel by inserting a balloon catheter into a diseased vessel through a peripheral artery of a percutaneous puncture patient to dilate a stenotic diseased region.

The balloon dilating catheter consists of a balloon with the dilating ability at the distal end and a proximal pipe section. When the balloon part of the balloon dilatation catheter is pushed to a lesion, the balloon is expanded by liquid pressure, so that a lesion blood vessel is opened, the blood flow is recovered to be normal, the liquid balloon is pumped back to relieve the pressure after the operation is finished, and then the catheter is taken out from the blood vessel of the patient.

With the wide development of PCI surgery, the physician has increasingly complex lesions to treat, and therefore the performance requirements for catheters are increasing. In the current clinical application, the catheter has the biggest problem that the catheter can not pass through a lesion part and accounts for about 80 percent of the feedback of quality complaints. To enhance the ability of the catheter to pass through lesions, most companies have included reducing the size of the passing outer diameter (cross profile) of the catheter, and coating the catheter surface, particularly the balloon portion of the catheter.

On the other hand, in the process of withdrawing the balloon after the balloon is expanded, the profile diameter (profile) of the balloon after pressure relief is too large, so that the vessel wall is easily damaged and the stent is easily displaced after implantation, and the curative effect of the operation is reduced. Finally, while the single use of medical devices significantly reduces the risk of infection, it also results in increased costs for patient treatment, and how to increase the multiple use of medical devices in the same patient treatment would be an effective solution. In order to realize smooth retraction and multiple utilization rate after balloon expansion, the reduction of the profile diameter of the balloon after pressure relief is the most feasible way. After the balloon is expanded and decompressed, the balloon cannot be folded back to the low-profile diameter state before the operation again, the state of three wings, four wings and five wings can be recovered at most, the number of wings capable of being recovered is determined according to the profile diameter, and the larger the number of wings is, the smaller the profile diameter is.

Therefore, on the one hand, the ability of the balloon to pass through the lesion should be increased, and on the other hand, the deflated profile diameter should be as small as possible during the complete balloon withdrawal process after expansion.

Disclosure of Invention

In view of the above, it is a primary object of the present invention to provide a medical balloon having a smaller profile diameter after decompression, a method for manufacturing the same, and a balloon-dilating catheter, and it is another object of the present invention to provide a balloon having a better ability to pass through a lesion at the same time.

To achieve the above objects, according to one aspect of the present invention, there is provided a medical balloon.

The medical balloon comprises a balloon conical part and a balloon straight section, wherein a plurality of raised longitudinal ribs are arranged on the balloon straight section at intervals along the circumferential direction.

Optionally, the longitudinal ribs are formed by applying a band-like coating on the balloon straight section.

Optionally, the coating is a polyurethane-based coating, a hydrophilic lubricious coating, an acrylic coating, or a silicone high-resilience coating.

Optionally, the hydrophilic lubricating coating is polyethylene oxide, an acrylic or acrylamide-based hydrophilic polymer, or polyvinylpyrrolidone.

Optionally, the longitudinal ribs are formed by thickening the balloon material over the strip-like regions.

Optionally, an included angle between the extending direction of the longitudinal rib and the axial direction of the balloon is greater than or equal to zero, so that the longitudinal rib extends on the surface of the balloon in a clockwise or anticlockwise rotating manner or extends in parallel with the axial direction of the balloon.

Optionally, the included angle is less than 15 °.

Optionally, the number of longitudinal ribs is 3, 4 or 5.

Optionally, the longitudinal ribs are arranged at equal intervals along the circumference of the balloon.

Optionally, the material of the medical balloon is polyurethane elastomer, nylon, block polyether amide resin, polyolefin, or polyester.

According to another aspect of the present invention, there is provided a balloon dilation catheter having a balloon of the present invention at a distal end thereof.

In accordance with yet another aspect of the present invention, a method of manufacturing a medical balloon is provided.

This method of manufacturing a medical balloon of the present invention comprises: the balloon tube is placed into a mould and is formed after stretching and blowing, and a cavity of the mould is provided with a plurality of areas expanded to the outside, so that a plurality of raised longitudinal ribs are distributed on a formed balloon straight section at intervals along the circumferential direction.

Optionally, the cavity of the mold is triangular, rhomboidal or pentagonal.

According to yet another aspect of the present invention, another method of manufacturing a medical balloon is provided.

This method of manufacturing a medical balloon of the present invention comprises: the method comprises the following steps of (1) primarily forming a balloon pipe after stretching and blowing, then placing the primarily formed balloon in a mold, pressurizing the balloon to a preset pressure, and finally heating the mold to a preset temperature for a preset time; the cavity of the mould is provided with a plurality of areas expanded to the outside, so that a plurality of raised longitudinal ribs are distributed on the formed flat section of the saccule at intervals along the circumferential direction.

Optionally, the cavity of the mold is triangular, rhomboidal or pentagonal.

According to the technical scheme of the invention, the straight section of the balloon is provided with a plurality of raised longitudinal ribs, so that the balloon is decompressed to form a wing-shaped structure with the longitudinal ribs as the top, and the balloon has a smaller profile diameter and is easy to retract; the longitudinal ribs formed by the hydrophilic lubricating coating can ensure that the balloon has good trafficability in a folded and pressed state, can accurately expand a diseased part in an expanded state, and can also ensure that the balloon has a smaller profile diameter after being decompressed.

Drawings

The drawings are included to provide a better understanding of the invention and are not to be construed as unduly limiting the invention. Wherein:

FIG. 1 is a schematic illustration of the profile of a balloon in an expanded state according to an embodiment of the invention;

FIG. 2 is a schematic illustration of a folded, crimped state of a balloon having three longitudinal ribs according to an embodiment of the invention;

FIG. 3 is a schematic illustration of a balloon having three longitudinal ribs inflated to a pressure relief state in accordance with an embodiment of the present invention;

FIG. 4 is a schematic illustration of the profile of another balloon according to an embodiment of the invention;

FIG. 5 is a schematic illustration of a cross-section of a balloon in an expanded state according to an embodiment of the invention;

FIG. 6A is a front view and a schematic cross-sectional view B-B of a mold for making a balloon according to an embodiment of the invention;

FIG. 6B is a schematic view of section A-A in FIG. 6A;

FIG. 6C is an enlarged schematic view of section B-B of FIG. 6A;

fig. 7A, 7B, 7C are schematic views of another mold for manufacturing a balloon according to an embodiment of the invention.

Detailed Description

Exemplary embodiments of the present invention are described below with reference to the accompanying drawings, in which various details of embodiments of the invention are included to assist understanding, and which are to be considered as merely exemplary. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope and spirit of the invention. Also, descriptions of well-known functions and constructions are omitted in the following description for clarity and conciseness.

FIG. 1 is a schematic representation of the profile of a balloon in an expanded state according to an embodiment of the present invention. As shown in fig. 1, the balloon 1 has a balloon straight section 11 and balloon

tapered sections

121 and 122 in an expanded state. A plurality of convex longitudinal ribs 13 extending axially along the balloon are distributed in the circumferential direction of the straight section of the balloon, one longitudinal rib can be seen in the drawing, and the number of the longitudinal ribs can be three to five or more.

Taking three longitudinal ribs as an example, the folded and pressed state is shown in fig. 2. Fig. 2 is a schematic view of a state in which a balloon having three longitudinal ribs is folded and crimped according to an embodiment of the present invention. Fig. 2 is a view in section, with

longitudinal ribs

21, 22, 23 at the ends of the balloon 2 at the folds. The state of the balloon after being inflated and decompressed is shown in fig. 3, and fig. 3 is a schematic diagram of the state of the balloon with three longitudinal ribs after being inflated and decompressed according to the embodiment of the invention. Due to the existence of the raised longitudinal ribs, the strength of the balloon wall between the adjacent longitudinal ribs is lower than that of the position of the longitudinal rib, so that the balloon wall between the adjacent longitudinal ribs is more easily bent inwards during pressure relief, and a wing-shaped structure taking the longitudinal ribs as the top is formed, so that the balloon has a smaller profile diameter after pressure relief, for example, three

longitudinal ribs

311, 312 and 313 of the balloon 3 in fig. 3 are respectively located at the tops of the

wings

321, 322 and 323. The greater the number of longitudinal ribs, the greater the number of wings that recover after balloon inflation for decompression. However, the longitudinal ribs should not be too many, otherwise the balloon is difficult to recover.

It can be seen from fig. 3 that if the wings formed by the balloon after being inflated and decompressed are inclined, the profile diameter of the balloon at the moment can be reduced. For this purpose, a preferred configuration is such that the longitudinal ribs are at an angle to the axial direction of the balloon, which angle is the angle between the longitudinal ribs and the projection of the balloon axis onto a plane parallel to the balloon axis. The included angle may be within 15 °. Referring to fig. 4, fig. 4 is a schematic view of the profile of another balloon according to an embodiment of the invention, wherein the surface of balloon 4 has inclined

longitudinal ribs

411, 412. Such oblique longitudinal ribs may be three to five or more, extending at the balloon surface with a clockwise or counterclockwise rotation.

One preferred way to form the longitudinal ribs is to apply a band-like coating to the straight section of the balloon, which may be selected from polyurethane-based coatings, hydrophilic lubricious coatings, acrylic coatings, or silicone elastomeric coatings, among others. Among them, a hydrophilic lubricating coating such as polyethylene oxide, acrylic or acrylamide-based hydrophilic polymers, or polyvinylpyrrolidone, etc. is preferably used. The position of the coating after the balloon is expanded is shown in fig. 5, fig. 5 is a schematic view of a cross-section of the balloon in an expanded state according to an embodiment of the present invention. In fig. 5, the

coatings

511, 512, 513 of the balloon 5 each form longitudinal ribs. The presence of the coating makes the mechanical properties of the balloon wall at the longitudinal ribs different from those of the longitudinal ribs, so that the balloon wall between the longitudinal ribs is more easily contracted after the balloon 5 is decompressed, and wings similar to those shown in fig. 3 can be formed, thereby obtaining a smaller balloon profile diameter. The expanded balloon can be directly coated with a coating on the surface, and for the coating accuracy, the expanded balloon can be placed in a hollowed-out formwork, and the hollowed-out part is coated.

Because the hydrophilic lubricating coating is adopted, the outer diameter of the balloon after expansion and pressure relief is reduced due to the formation of the longitudinal ribs, and the lubricating property of the hydrophilic lubricating coating is favorable for improving the capability of passing through a lesion part; and as can be seen from fig. 5, the balloon is in an expanded state, only a part of the surface of the balloon is coated with the hydrophilic lubricating coating, so that the balloon is not easy to slip during expansion, and a diseased region can be accurately expanded, therefore, the longitudinal ribs formed by the hydrophilic lubricating coating can ensure that the balloon has good trafficability in a folded and pressed state, can accurately expand the diseased region in the expanded state, and can also ensure that the balloon has a smaller profile diameter after being decompressed, thereby achieving the effect of achieving three purposes at one time.

In the implementation, a 2530-specification balloon can be selected, the material of the balloon is PEBAX7233, and the material of the coating can be polyvinylpyrrolidone (PVP). The coating of the balloon is performed according to fig. 1 and 2, i.e. the hydrophilic lubricating coating is located on the outer layer of the folded balloon, here where the outer profile diameter of the folded balloon is the largest. After coating, the result is as follows: the balloon is filled with 1:1 contrast solution under 14atm for 10 times, and the three wings are uniformly restored. The coating material can also be polyethylene oxide (PEO) and coated according to the figure 4, so that the balloon forms three uniform wings after being expanded and decompressed. After the hydrophilic lubricating coating is coated, a three-point pulley structure is constructed, which is beneficial to the first and second pushing of the saccule and the passing of pathological changes.

The longitudinal ribs may also be formed by thickening the balloon material in the strip-shaped regions, and may be implemented by using a mold as shown in fig. 6A to 7C. For example, a balloon tube with an inner diameter of 0.0230inch and an outer diameter of 0.0355inch can be used, and placed in a mold as shown in fig. 6A to 6C, and subjected to stretch blow molding to form the balloon tube. Fig. 6A is a front view and a schematic view of a section B-B of a mold for manufacturing a balloon according to an embodiment of the present invention, fig. 6B is a schematic view of the section a-a in fig. 6A, and fig. 6C is an enlarged schematic view of the section B-B in fig. 6A. Wherein the cavity 61 of the mold 60 has four outwardly expanded

regions

611, 612, 613, 614 so that the balloon material thickens in these four regions to form longitudinal ribs. The four longitudinal ribs have different thicknesses from other parts of the balloon, and form stripes which are longitudinally and evenly distributed on the working section of the balloon. The thickness of the longitudinal ribs is 1.5mil, the thickness of the other parts of the balloon is 1.2mil, the nominal diameter of the balloon is 3.5mm, and the pressure resistance of the balloon is 20 atm.

Fig. 7A, 7B, 7C are schematic views of another mold for manufacturing a balloon according to an embodiment of the present invention, wherein fig. 7A, 7B and 7C are a front view, a-a sectional view and B-B sectional view, respectively. Firstly, a PEBAX sacculus tubular product with the outer diameter of 0.0385inch and the inner diameter of 0.0265inch is subjected to stretching and blowing for primary forming, the sacculus after primary forming is placed in a heatable hollow rhombic mold shown in figures 7A to 7C, the sacculus is pressurized to 6atm, the mold is heated to 100 ℃, and after 5min, the pressure is released and the sacculus is taken out, so that the completely formed sacculus is obtained. Due to the existence of the

top corners

711, 712, 713 and 714 of the rhombus 71 in the mold, the obtained balloon has four longitudinal stripes which are different from other parts in thickness and are evenly distributed on the working section of the balloon at intervals in the circumferential direction of the balloon, the thickness of the part is 1.6mil, the thickness of the other parts of the balloon is 1.3mil, the nominal diameter of the balloon is 4.0mm, and the pressure resistance of the balloon is 19 atm. One of ordinary skill in the art will readily recognize that the mold used to form the balloon may also be triangular or pentagonal to form three or five longitudinal ribs having a thickness different from the remainder of the balloon.

The balloon material can also be selected from polyurethane elastomer, nylon, block polyether amide resin, polyolefin, polyester and the like. The prepared balloon can be applied to various balloon dilatation catheters, and the balloon dilatation catheter can be arranged at the far end of the catheter.

The above-described embodiments should not be construed as limiting the scope of the invention. Those skilled in the art will appreciate that various modifications, combinations, sub-combinations, and substitutions can occur, depending on design requirements and other factors. Any modification, equivalent replacement, and improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A medical balloon comprises a balloon conical part and a balloon straight section, and is characterized in that a plurality of raised longitudinal ribs are arranged on the balloon straight section at intervals along the circumferential direction;

the longitudinal ribs are formed by coating a strip-shaped coating on the straight section of the balloon;

the included angle between the extending direction of the longitudinal ribs and the axial direction of the balloon is larger than or equal to zero, so that the longitudinal ribs can rotate clockwise or anticlockwise on the surface of the balloon to extend or extend in parallel with the axial direction of the balloon; the angle is the angle between the longitudinal rib and the projection of the balloon axis on a plane parallel to the balloon axis.

2. The medical balloon of claim 1, wherein the coating is a polyurethane-based coating, a hydrophilic lubricious coating, an acrylic coating, or a silicone elastomeric coating.

3. The medical balloon of claim 2, wherein the hydrophilic lubricious coating is polyethylene oxide, an acrylic or acrylamide-based hydrophilic polymer, or polyvinylpyrrolidone.

4. The medical balloon of claim 1, wherein the included angle is less than 15 °.

5. The medical balloon of any one of claims 1-3, wherein the number of longitudinal ribs is 3, 4, or 5.

6. The medical balloon of any one of claims 1-3, wherein the longitudinal ribs are equally spaced circumferentially along the balloon.

7. The medical balloon of any one of claims 1-3, wherein the material of the medical balloon is a polyurethane elastomer, nylon, block polyetheramide resin, polyolefin, or polyester.

8. A balloon dilation catheter having a distal end with a balloon according to any one of claims 1 to 7.

9. A method of manufacturing a medical balloon, comprising:

the method comprises the following steps of (1) primarily forming a balloon pipe after stretching and blowing, then placing the primarily formed balloon in a mold, pressurizing the balloon to a preset pressure, and finally heating the mold to a preset temperature for a preset time;

the cavity of the mould is provided with a plurality of areas expanded to the outside, so that a plurality of raised longitudinal ribs are distributed on the formed balloon only on the straight section at intervals along the circumferential direction; the included angle between the extending direction of the longitudinal ribs and the axial direction of the balloon is larger than or equal to zero, so that the longitudinal ribs can rotate clockwise or anticlockwise on the surface of the balloon to extend or extend in parallel with the axial direction of the balloon; the angle is the angle between the longitudinal rib and the projection of the balloon axis on a plane parallel to the balloon axis.

10. The method of claim 9, wherein the cavities of the mold are triangular, diamond-shaped, or pentagonal.