WO2019149173A1

WO2019149173A1 - Dilatation balloon and balloon dilatation catheter

Info

Publication number: WO2019149173A1
Application number: PCT/CN2019/073471
Authority: WO
Inventors: 刘琛; 姚映忠; 岳斌
Original assignee: 上海微创心通医疗科技有限公司
Priority date: 2018-02-02
Filing date: 2019-01-28
Publication date: 2019-08-08
Also published as: CN110123489A

Abstract

A dilatation balloon (10-1) and a balloon dilatation catheter (100), the dilatation balloon (10-1) comprising a balloon body having an intermediate passage (9) and a valve membrane (7) disposed on the intermediate passage (9); the valve membrane (7) contracts or expands after bearing a force such that the intermediate passage (9) communicates unidirectionally. Thus, the present invention is helpful in ensuring the effect of the dilatation balloon (10-1) in expanding a valve, and may also reduce the structural complexity of the balloon dilatation catheter (100), and ensure that the balloon dilatation catheter (100) may pass through.

Description

Dilatation balloon and balloon dilatation catheter

Technical field

The present invention relates to the field of medical device technology, and in particular to an expansion balloon and a balloon dilatation catheter.

Background technique

Since Inoue successfully developed percutaneous balloon valvuloplasty (PBV) in 1984, PBV has become one of the important methods for the treatment of valvular heart disease. Percutaneous balloon valvuloplasty has the advantages of small trauma, safety, and curative effect, which replaces open heart valve incision/separation to some extent. For patients with severe calcific aortic stenosis and surgical contraindications or high risk, transcatheter aortic valve placement (TAVI) is applied to the valvular balloon through the femoral artery to deliver the prosthetic heart valve to the aortic valve area. Open, thereby completing the prosthetic valve placement and restoring the valve function. The expansion of the stenotic lesion through the valve balloon facilitates the implantation of the valve stent, and the posterior expansion of the balloon balloon after the aortic valve implantation can make the aortic valve adhere better and the healing effect is better.

Typically, the valve balloon is designed in a cylindrical configuration. This design facilitates the uniform expansion of the balloon at the lesion to conform to the inner wall of the blood vessel and avoid tearing of the blood vessel caused by excessive expansion of the blood vessel. However, the cylindrical balloon will block the blood flow during the expansion process, temporarily impairing the heart, limiting the operable time of the valve operation, affecting the balloon dilatation valve effect, and also requiring the pacing after the balloon is expanded. Used by the device.

When the current balloon is dilated, the design that allows blood flow through the balloon is a hollow balloon structure with a movable spherical balloon in the middle that inhibits blood flow from the aorta to the left ventricle, avoiding an increase in the left ventricle. Capacity and stroke volume. However, this design still has problems: First, the catheter structure is complex, technically difficult to achieve, and also reduces the passage of the catheter; second, the outer surface of the valve balloon is not fixed or bound, so that the expanded balloon may be deformed, The balloon compliance is higher, which affects the balloon dilatation valve effect, and the aortic valve calcification lesion is easy to pierce the balloon.

Therefore, based on the problems in the prior art, it is necessary to develop a new type of aortic valve dilatation balloon to meet its use in aortic valve surgery.

Summary of the invention

In view of the above, the present invention provides an expansion balloon and a balloon dilatation catheter, which can suppress the reflux of the aortic blood to the left ventricle, ensure the effect of the balloon dilating the valve, and can also reduce the structural complexity of the catheter and ensure the catheter. Passivity.

According to an aspect of the invention, an expansion balloon is provided, the expansion balloon comprising a balloon body having an intermediate passage and a valve membrane disposed on the intermediate passage; the valve membrane is contracted or expanded after being stressed So that the intermediate channel is unidirectional.

Optionally, the valve membrane has a cavity, one end of the cavity is closed to form a closed end, and the other end is open to form an open end.

Optionally, the valve membrane is expanded to be a hollow cone, and the bottom of the cone is disposed perpendicular or oblique with respect to an axis of the intermediate passage.

Optionally, the valve membrane is disposed between the distal end and the proximal end of the intermediate passage, or the distal end of the intermediate passage.

Optionally, the material of the valve film is selected from one or more combinations of a fluoropolymer, a polyester, a polyamide, a polyvinyl chloride, a nylon elastomer, and a polyurethane elastomer.

Optionally, a coating film is disposed on an outer surface of the balloon body, and the coating partially adheres to an outer surface of the balloon body.

Optionally, the balloon body comprises at least three balloon bodies, at least three of which are arranged in parallel and form the intermediate channel.

According to another aspect of the invention, a balloon dilatation catheter is provided, comprising the dilatation balloon.

Optionally, the balloon dilatation catheter further includes an inner tube and an outer tube; the inner tube is inserted into the outer tube, and the inner tube protrudes from a section of the outer tube and the expansion ball is sleeved a distal end of the dilatation balloon is coupled to the inner tube, a proximal end of the dilatation balloon being coupled to the outer tube and the inner tube.

Optionally, one end of the valve membrane is fixedly coupled to the inner tube and forms a closed end, and the other end of the valve membrane is coupled to the inner tube and/or the balloon body and forms an open end.

Optionally, the open end of the valve membrane is connected to the inner tube and/or the balloon body via a plurality of connecting wires.

Optionally, the connecting wire is connected to the inner tube and/or the balloon body by hot melt, sewing or glue.

Optionally, the connecting wire is connected to the open end of the valve film by hot melt, sewing or glue.

In summary, according to the technical solution provided by the present invention, for the dilatation balloon and the corresponding balloon dilatation catheter, the dilation balloon is internally formed with an intermediate passage, and the intermediate passage is provided with a valve membrane, and the valve membrane is subjected to The force is contracted or expanded to achieve a unidirectional conduction of the intermediate passage, and thus, during the operation, when the expansion balloon is placed on the human valve, blood flow can be normally circulated through the intermediate passage, so that when the valve is expanded Blood flow is not affected and, therefore, the dilatation balloon is suitable for a one-way blood flow channel, especially a heart valve. Therefore, the valve membrane can be used to suppress the reflux of the aortic blood to the left ventricle, thereby reducing the left ventricular volume and the stroke volume, thereby ensuring the effect of the balloon dilating the valve. In particular, the valve membrane does not require a complicated catheter to be fitted, thereby reducing the structural complexity of the balloon-expanding catheter and being technically easy to implement without increasing the contour size of the catheter, thereby ensuring the catheter Passivity.

DRAWINGS

The drawings are intended to provide a better understanding of the invention and are not intended to limit the invention. among them:

1a is a schematic structural view of a balloon dilatation catheter according to an embodiment of the present invention;

Figure 1b is a cross-sectional view of the balloon dilatation catheter of Figure 1a taken along line B-B;

Figure 1c is a cross-sectional view of the balloon dilatation catheter of Figure 1a taken along line A-A;

Figure 1d is another cross-sectional view of the balloon dilatation catheter of Figure 1a taken along line B-B;

Fig. 1e is a schematic view showing the structure of a valve film according to an embodiment of the present invention.

In the picture:

100-balloon dilatation catheter, 10-1-expansion balloon, 10-2-balloon, 1-straight segment, 2-near tube segment, 3-distal tube segment, 4-outer tube, 5-inner tube, 6 - Laminating, 7-valve, 8-connector, 9-intermediate channel.

Detailed ways

In order to clarify the objects, advantages and features of the present invention, the dilatation balloon and balloon dilatation catheter of the present invention will be further described in detail below with reference to Figures 1a to 1e. It should be noted that the drawings are in a very simplified form and all use non-precise proportions, and are only for convenience and clarity to assist the purpose of the embodiments of the present invention.

As used in the specification, the singular forms " The term "or" is used in the meaning of "and/or" as used in this specification unless the context clearly dictates otherwise. The term "proximal" generally refers to the end of the corresponding member that is adjacent to the operator, and "distal" refers to the end of the corresponding member that is remote from the operator. As used in this specification, the term "interior" generally refers to the direction of the axis near the corresponding member, and the term "outer" generally refers to the direction away from the axis of the corresponding member.

In percutaneous balloon valvuloplasty, the valve is delivered through the femoral artery (ie, the balloon is expanded), and the prosthetic heart valve is delivered to the aortic valve region to open, thereby completing the prosthetic valve placement and restoring the valve function. Among them, the expansion of the stenotic lesion through the valve balloon is beneficial to the implantation of the valve stent, and the posterior expansion of the balloon balloon through the aortic valve can make the aortic valve adhere better and the healing effect. Better.

Here, the dilatation balloon provided by the present invention is not limited to the aortic valve, and may be other valves in the heart, such as a mitral valve, a tricuspid valve, and a pulmonary valve. In addition, in addition to the intracardiac valve, it may also be a venous valve. In addition, since the dilatation balloon of the present invention can be composed of a plurality of balloon bodies and has a large diameter, it is particularly suitable for the aortic valve. In the following description, the present invention is exemplified by the application of the dilatation balloon on the aortic valve. It is to be understood that the invention is not limited thereto.

1a is a schematic structural view of a balloon dilatation catheter 100 according to an embodiment of the present invention, FIG. 1b is a cross-sectional view of the balloon dilatation catheter 100 shown in FIG. 1a along the line BB, and FIG. 1c is a balloon dilation shown in FIG. 1a. A cross-sectional view of the catheter 100 along the line AA. As shown in Figures 1a to 1c, the balloon dilatation catheter 100 includes an expansion balloon 10-1, and the dilation balloon 10-1 includes a balloon body having an intermediate passage 9, thus expanding the balloon When the balloon 10-1 is placed on the aortic valve, blood flow can be normally circulated through the intermediate passage 9. Obviously, during the expansion of the balloon 10-1, the blood flow is not hindered, so that the blood supply to the heart can be ensured, thereby prolonging the operation time of the valve operation and improving the effect of the balloon-expanding valve. Simplifies the operation without the need for a pacemaker.

Further, in order to prevent blood flow from flowing back from the aorta to the left ventricle, the dilatation balloon 10-1 of the present embodiment further includes a valve membrane 7, which is disposed on the intermediate passage 9 for realizing the intermediate passage 9 Unidirectional conduction allows blood flow to flow only from the left ventricle to the aorta, but not from the aorta to the left ventricle.

Further, the valve film 7 ensures the unidirectional conduction of the intermediate passage 9 by force contraction or expansion in the present embodiment. Specifically, when blood flow flows from the left ventricle to the aorta, the valve membrane 7 is closed and contracted by the blood flow to maintain the intermediate passage 9; otherwise, when the blood flow flows from the aorta into the left ventricle At this time, the valve membrane 7 is expanded by the blood flow impact to block the intermediate passage 9, thereby interrupting the passage of blood flow. The material of the valve film 7 may be a medical polymer material such as a fluoropolymer, a polyester, a polyamide, a polyvinyl chloride, a nylon elastomer, a polyurethane elastic rubber, or the like, or a polymer of two or more of these materials. Or complex.

In the present embodiment, the aortic blood is prevented from flowing back to the left ventricle through the valve membrane 7, thereby reducing the left ventricular volume and the stroke volume, thereby ensuring the effect of the balloon dilating the valve. It is important that the opening and closing of the valve membrane 7 is completed only by the impact of blood flow, so that the structure of the balloon dilatation catheter can be simplified, technically easy to implement, and the contour size of the catheter is not increased, thereby ensuring the catheter. Passivity.

In order to form the intermediate passage 9, the dilatation balloon 10-1 includes at least three balloon bodies 10-2, and the balloon body 10-2 shown in the drawing is six, but is not limited thereto. The at least three balloon bodies 10-2 are arranged in parallel and form the intermediate channel 9. Here, the parallel arrangement means that the axes of the at least three balloon bodies 10-2 are arranged in parallel, in particular the straight segments 1 of the at least three balloon bodies 10-2 are arranged in parallel. However, at least three of the balloon bodies 10-2 are not limited to be arranged in parallel in a head-to-tail alignment manner to form a hollow cylinder, and may be arranged in parallel in a staggered manner and internally form the intermediate passage 9. In this embodiment, the at least three balloon bodies 10-2 are preferably arranged in parallel in a hollow cylinder to obtain an expanded balloon 10-1 having a smaller outer shape.

Further, when the number of the balloon bodies 10-2 is three or more, in a preferred embodiment, the two adjacent balloon bodies 10-2 may be fixed by glue bonding. In this way, the shape of the dilatation balloon 10-1 formed by the plurality of balloon bodies 10-2 can be stabilized, and the position of the balloon body 10-2 remains unchanged after the balloon is filled, and the blood flow channel can be left unaffected in the middle. . Furthermore, for any one of the balloon bodies 10-2, a medical polymer material such as a polymer such as polyamide or polyester, or a mixture or composite of polymers may be used. In the present embodiment, the balloon body 10-2 can adopt an existing structure, thereby reducing the use cost.

Preferably, the dilatation balloon 10-1 further comprises a coating 6 disposed on the outer surface of the balloon body and partially conforming to the outer surface of the balloon body such that the balloon At the time of expansion, the film 6 can directly contact the inner wall of the blood vessel, and since the film 6 can be better adhered to the inner wall of the blood vessel, the effect of the balloon-expanding valve can be enhanced. It is worth mentioning that the film 6 can also bind and shape the balloon, so that the expanded balloon does not deform, the balloon is more adaptable, and the balloon is expanded to expand the valve.

More preferably, the strength of the coating 6 is higher than the strength of any one of the balloon bodies 10-2 (such as tensile strength, flexural strength, yield strength, etc.) to enhance the expansion of the balloon 10-1 in the aortic valve The puncture resistance of the calcified lesion increases the balloon's pressure resistance and reduces compliance, thereby enhancing the balloon expansion force. In actual operation, the strength of the coating 6 can be made higher than the strength of any one of the balloon bodies 10-2 by selecting different materials or different molding methods.

In one embodiment, the balloon body 10-2 is made of Nylon 12, and the film 6 may be made of a PET material. The tensile strength of Nylon12 can be selected between 138Mpa and 275Mpa, the flexural strength can be between 90Mpa and 214Mpa, the tensile strength of PET is ≥275MPa, and the flexural strength is between 148MPa and 310Mpa.

When the strength of the film 6 is higher than the strength of any one of the balloon bodies 10-2, the thickness of the film 6 can be lowered as much as possible to reduce the profile (profile size) after the balloon is crimped. The thickness of the coating 6 is limited to 0.01 mm to 0.15 mm in terms of coronary blood vessels, peripheral blood vessels, and other blood vessels in the body in which calcified stenosis lesions are present.

In one embodiment, the material of the coating film 6 is selected from medical polymer materials, more preferably polymer materials such as polyester, polyamide, polyethylene, fluoropolymer, etc., or these materials. Multiple combinations. Without limitation, the film 6 is realized by a film forming process, or by braiding, or a composite structure of a film and a braid. The film structure 6 of the film structure can fix the existing polymer film to the outer surface of the balloon body after being pressurized and expanded by glue. The glue can be made of biocompatible epoxy glue, polyurethane glue, light curing glue and silica gel. The film of the woven structure can be fixed to the surface of the balloon body by glue or suture.

Preferably, the coating 6 may be coated with a hydrophilic coating to enhance the passage of the balloon in the blood vessel. Generally, a hydrophilic material such as polyvinylpyrrolidone (PVP), polyvinyl alcohol (PAA), polyacrylic acid (PAA), or polyethylene glycol (PEG) may be selected.

Further, in one embodiment, as shown in FIG. 1b, the valve membrane 7 can be disposed between the distal end and the proximal end of the intermediate passage 9; or, in another embodiment, as shown in Figure 1d, The valve membrane 7 can also be disposed at the distal end of the intermediate passage 9, and a portion can also extend beyond the distal end of the intermediate passage 9; alternatively, the valve membrane 7 can also be disposed at the proximal end of the intermediate passage 9, but considering The special configuration of the valve membrane 7 is generally located in the intermediate passage 9 to better block the structure. Therefore, the valve membrane 7 can be located at different locations on the intermediate passage 9. However, a plurality of valve membranes 7 are not provided on the intermediate passage 9, and a plurality of valve membranes 7 may be provided. The plurality of valve membranes 7 are arranged along the axial direction of the intermediate passage 9 to be redundantly designed to ensure practical use. Reliability.

Further, the valve membrane 7 may have a cavity, and one end of the cavity is closed to form a closed end and corresponds to the distal end of the expanded balloon 10-1, and the other end of the cavity is open to form an open end. And corresponding to the proximal end of the dilatation balloon 10-1, wherein the closed end is fixedly disposed, and the open end is expanded to be engaged with the intermediate passage 9. When the open end of the valve film 7 is in contact with the intermediate passage 9, the intermediate passage 9 is blocked; when the open end of the valve film 7 is contracted, the intermediate passage 9 is Was unblocked. Obviously, the size of the open end is greater than or equal to the effective size of the intermediate passage 9. Here, the effective size of the intermediate passage 9 refers to the diameter of the cavity at the position of the intermediate passage 9 for fitting with the open end. For example, when the cross-sectional shape of the intermediate passage 9 is, for example, "star" as shown in FIG. 1c, the cross-sectional shape of the open end of the valve film 7 may match or not match the "star". However, the cross-sectional dimension of the open end is at least consistent with the "star" so that the open end and the cross section of the intermediate passage 9 are effectively fitted without causing leakage.

1e is a schematic structural view of a valve film 7 according to an embodiment of the present invention. As shown in FIG. 1e, the valve film 7 may be a hollow cone, but is not limited to the illustrated cone, as long as it is similar to FIG. 1e. The structure shown inside is hollow and one end is closed at the other end. For the cone, the bottom (round bottom) of the cone can be arranged perpendicular or non-vertically with respect to the axis of the intermediate channel 9, i.e. the bottom can also be inclined. In practice, the edge of the bottom of the cone is intended to be attached to the intermediate channel 9, for example the edge of the bottom of the cone and the intermediate channel 9 surrounded by the straight section 1 of each balloon body 10-2. The inner wall is attached, and the top of the cone needs to be fixed to ensure that the diaphragm 7 does not move.

As shown in FIG. 1b or 1d, for any one of the balloon bodies 10-2, it may comprise a straight section 1, a proximal section 2 and a distal section 3, the straight section 1 being located in the proximal section 2 and the distal section 3 The cross-sectional dimension of the proximal pipe section 2 is smaller than the cross-sectional dimension of the straight section 1. The shape of the straight section 1 is generally cylindrical. Further, the straight section 1 may further include a tapered section at both ends (the large diameter end of the tapered section is connected to the cylindrical section in the middle). Wherein, in the present embodiment, the proximal tube segment 2 corresponds to a direction close to a doctor or operator, and the distal tube segment 3 corresponds to a direction away from the doctor or close to the patient.

The balloon dilatation catheter 100 further comprises an outer tube 4 for sealingly connecting with the outer tube 4 and the inner tube 5, and an inner tube 5 for sealing connection with the inner tube 5. Actually, the inner tube 5 passes through the outer tube 4, and the inner tube 5 extends out of the portion of the outer tube 4 to provide the expansion balloon 10-1. When assembled, the proximal section 2 of all of the balloon bodies 10-2 is sealingly connected to the distal end of the outer tube 4 on the one hand and to the inner tube 5 on the other hand. More specifically, the proximal end of the proximal tube section 2 can be inserted into the gap between the inner tube 5 and the outer tube 4 to be in sealing connection with the outer wall of the inner tube 5 and the inner wall of the outer tube 4. It should be understood that the proximal section 2 may also not be inserted into the gap between the inner tube 5 and the outer tube 4, but rather is sealingly connected to the distal end of the outer tube 4.

Optionally, the proximal pipe section 2 is connected to the inner pipe 5 and the outer pipe 4 by means of glue, hot melt, etc. Preferably, all of the proximal pipe sections 2 are summarized at the same axial position on the inner pipe 5. Further, the distal section 3 of all of the balloon bodies 10-2 is in sealing connection with the section of the inner tube 5 extending beyond the outer tube 4. Optionally, the distal pipe section 3 is sealingly connected to the inner pipe 5 by means of glue, hot melt or the like. Preferably, all of the distal sections 3 are also summarized in the same axial position on the inner tube 5 (this axial position is near the distal end of the inner tube 5).

Further, in practical application, for any one of the balloon bodies 10-2, the inner cavity of the proximal pipe section 2 communicates with the gap between the outer pipe 4 and the inner pipe 5, so that the filling medium can pass through the inner pipe 5 and the outer pipe. The gap between the 4 and the entry into the straight section 1 via the proximal section 2 achieves the filling of the straight section 1. Thus, the dilatation balloon 10-1 of the present embodiment integrally forms a catheter portion that is tapered at both ends and a balloon portion that is located at the center, wherein a catheter portion at the proximal end is used to provide a flow passage for the filling medium. The other conduit portion at the distal end may form a occlusion structure, wherein the one conduit portion is defined by a plurality of proximal tubular segments 2, and the other conduit portion is defined by a plurality of distal tubular segments 3, and The balloon portion is formed by parallel arrangement of the straight segments 1 of the plurality of balloon bodies 10-2, thereby forming a working region of the dilatation balloon 10-1, a portion of the outer surface of the working region being used for the aortic valve The vessel wall fits. Thus, the dilatation balloon 10-1 of the present embodiment does not affect the blood flow even when the valve is expanded, and can design a balloon of a larger size than the dilatation balloon composed of a single balloon. The need for different treatments.

With continued reference to Figure 1e, the closed end of the valve membrane 7 can be secured to the inner tube 5, but the fixed position is not limited to the interior or exterior of the expanded balloon 10-1. Further, the open end of the valve membrane 7 is preferably connected to the inner tube 5 or the dilatation balloon 10-1 via a plurality of connecting wires 8. The material of the connecting wire 8 may be selected from polymer fibers and has good strength.

For example, one end of the plurality of connecting wires 8 is connected to the edge of the open end of the valve film 7, and the connection manner may be glue bonding, hot-melt bonding or stitching, if the material melting point of the connecting wire 8 and the valve film 7 is used. Similar or identical, a hot melt connection is preferred. The other end of the plurality of connecting wires 8 is connected to the inner tube 5, and the connection manner may be glue bonding, hot-melt bonding or stitching. If the connecting wires 8 are similar to or the same as the material melting point of the inner tube 5, a hot-melt connection is preferred. However, the other end of the connecting line 8 can also be connected to the straight section 1 or other part of the balloon body 10-2, such as by glue to the straight section 1. Alternatively, the other end of the connecting wire 8 may be connected to the inner tube 5 or to the balloon body at the same time.

Finally, it is to be noted that the angle of the taper of the valve film 7, the size and length of the opening, and the number and length of the connecting wires 8 can be set according to the actual balloon size, which is not particularly limited in the present invention.

In summary, according to the technical solution provided by the embodiment of the present invention, for the dilatation balloon and the corresponding balloon dilatation catheter, the interior of the dilation balloon is formed with an intermediate channel, and the intermediate channel is provided with a valve membrane, and the The valve membrane is contracted or expanded after being forced to achieve a unidirectional conduction of the intermediate passage, so that during the operation, when the expansion balloon is placed on the human valve, blood flow can be normally circulated through the intermediate passage, so that The blood flow is not affected when the valve is expanded, and therefore, the dilatation balloon is suitable for a one-way blood flow channel, especially a heart valve. Therefore, the valve membrane can be used to suppress the reflux of the aortic blood to the left ventricle, thereby reducing the left ventricular volume and the stroke volume, thereby ensuring the effect of the balloon dilating the valve. In particular, the valve membrane does not require a complicated catheter to be fitted, thereby reducing the structural complexity of the balloon-expanding catheter and being technically easy to implement without increasing the contour size of the catheter, thereby ensuring the catheter Passivity.

The above description is only for the description of the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention. Any changes and modifications made by those skilled in the art in light of the above disclosure are all within the scope of the appended claims.

Claims

An expansion balloon, characterized in that the expansion balloon comprises a balloon body having an intermediate passage and a valve membrane disposed on the intermediate passage; the valve membrane is contracted or expanded after being forced to The intermediate channel is unidirectional.
The dilatation balloon according to claim 1, wherein said valve membrane has a cavity, one end of said cavity being closed to form a closed end, and the other end being open to form an open end.
The dilatation balloon according to claim 2, wherein said valve membrane is expanded to be a hollow cone, and a bottom of said cone is disposed perpendicularly or obliquely with respect to an axis of said intermediate passage.
The dilatation balloon of claim 1 wherein said valve membrane is disposed between a distal end and a proximal end of said intermediate passage or a distal end of said intermediate passage.
The dilatation balloon according to claim 1, wherein the material of the valve membrane is selected from the group consisting of fluoropolymer, polyester, polyamide, polyvinyl chloride, nylon elastomer, and polyurethane elastomer. One or more combinations.
The dilatation balloon according to claim 1, wherein a coating film is provided on an outer surface of the balloon body, the coating partially adhering to an outer surface of the balloon body.
The dilatation balloon of claim 1 wherein said balloon body comprises at least three balloon bodies, at least three of said balloon bodies being arranged in parallel and forming said intermediate channel.
A balloon dilatation catheter, comprising the dilatation balloon of any of claims 1-7.
A balloon dilatation catheter according to claim 8, wherein said balloon dilatation catheter further comprises an inner tube and an outer tube; said inner tube being inserted into said outer tube, and said inner tube extending beyond said outer tube a segment of the tube is provided with the expansion balloon; a distal end of the expansion balloon is coupled to the inner tube, and a proximal end of the expansion balloon is coupled to the outer tube and the inner tube .
A balloon dilatation catheter according to claim 9, wherein one end of said valve membrane is fixedly coupled to said inner tube and forms a closed end, and the other end of said valve membrane is associated with said inner tube and/or The balloon body is coupled and forms an open end.
The balloon dilatation catheter of claim 10, wherein the open end of the valve membrane is coupled to the inner tube and/or the balloon body by a plurality of connecting wires.
The balloon dilatation catheter of claim 11 wherein said connecting wire is coupled to said inner tube and/or said balloon body by heat fusion, suturing or glue.
A balloon dilatation catheter according to claim 11, wherein said connecting wire is connected to the open end of said valve membrane by heat fusion, sewing or glue.