CN213491415U

CN213491415U - Balloon catheter with self-adaptive bending function

Info

Publication number: CN213491415U
Application number: CN202021577076.8U
Authority: CN
Inventors: 刘斌
Original assignee: Sonosemi Medical Co Ltd
Current assignee: Sonosemi Medical Co Ltd
Priority date: 2020-07-31
Filing date: 2020-07-31
Publication date: 2021-06-22
Anticipated expiration: 2030-07-31

Abstract

The balloon catheter with the self-adaptive bending function is provided, a strip-shaped balloon and an inner tube arranged inside the balloon are arranged on the balloon catheter, two ends of the balloon are fixed on the inner tube respectively, and the tensile modulus of the inner tube is larger than that of the balloon; at least one section of bending ring used as a bending node when the sacculus is bent along a blood vessel is arranged in the length direction of the sacculus, and the wall thickness of the bending ring is smaller than that of a sacculus sac body outside the bending ring. The structure of the balloon catheter is improved, so that the balloon catheter can be bent in a self-adaptive manner along the bending direction of the blood vessel, the blood vessel is prevented from being damaged, and the clinical risk is reduced.

Description

Balloon catheter with self-adaptive bending function

Technical Field

The application belongs to the technical field of medical instruments, and particularly relates to a balloon catheter with a self-adaptive bending function.

Background

Currently, a balloon dilatation catheter is a common medical device for treating stenotic lesions in blood vessels, for example, when the common balloon in fig. 1 is expanded, if the tensile modulus of the balloon and the inner tube in the length direction is not consistent, that is, the displacement of the balloon 1 in the length direction is large, the deformation of the inner tube 2 in the length direction is small, and the two ends of the balloon are fixed on the inner tube, the balloon is bent, that is, the balloon has a "banana effect". Because the 'banana effect' causes uncertainty of the bending direction of the balloon, the vessel can be damaged and the operation fails, so that the 'banana effect' can be avoided when the common balloon is designed, and the strain of the balloon and the strain of the inner tube in the length direction are kept consistent as much as possible. However, in clinical application scenarios, a stenosis often occurs at a curved part of a blood vessel, such as a stenosis at a anastomotic stoma of a dialysis access, and if a balloon used cannot conform to the curved shape of the blood vessel to forcibly straighten the curved blood vessel, the balloon may cause damage to the blood vessel, which may cause a large clinical risk.

In order to solve the problem that the balloon cannot conform to the curved shape of the blood vessel in the prior art, one scheme is that the balloon is made of non-uniform materials, different positions on the balloon correspond to different materials, and the different materials have different elastic moduli so as to adapt to the curved shape of the blood vessel. However, this solution may make the balloon too soft, resulting in poor effect of dilating the lesion, and may not achieve the desired effect by controlling the bending only by the difference between the inner and outer expansion amplitudes of the blood vessel, which may cause damage to the blood vessel if the bending direction of the balloon is not the same as the bending direction of the blood vessel. The other scheme is that a section of non-telescopic linear limiting part with a certain length is added on one side of a catheter positioned in a balloon body of the balloon, in the process of expanding the balloon under pressure, the axial direction of the balloon body of the balloon can grow along with the increase of the pressure, and under the action of the linear limiting part arranged in the radial direction, the side part of the balloon cannot extend correspondingly, so that the balloon can be bent towards the side direction, and the curve shape of a blood vessel is adapted. But such a configuration limits the flexibility of the balloon. On one hand, the arrangement position of the linear limiting part limits the bending direction of the balloon, the bending nodes and the number are limited, and the complex shape of the blood vessel with multiple bending parts is difficult to overcome; on the other hand, the curvature radius of curvature of the balloon is limited according to the length of the linear stopper, and the shorter the length of the linear stopper, the larger the curvature radius of curvature of the balloon.

Therefore, the application scheme of how the balloon catheter effectively conforms to the bending part of the blood vessel still has a plurality of defects, and is a research problem that manufacturers of medical instruments need to improve at present.

Disclosure of Invention

An object of the embodiment of the present application is to provide a balloon catheter with a self-adaptive bending function, which improves the structure of the balloon catheter, so that the balloon catheter can be adapted to the bending direction of a blood vessel and is bent in a self-adaptive manner, thereby avoiding damage to the blood vessel and reducing clinical risks.

In order to achieve the purpose, the technical scheme adopted by the application is as follows: providing a balloon catheter with a self-adaptive bending function, wherein a strip-shaped balloon and an inner tube arranged in the balloon are arranged on the balloon catheter, two ends of the balloon are respectively fixed on the inner tube, and the tensile modulus of the inner tube is larger than that of the balloon; at least one section of bending ring used as a bending node when the sacculus is bent along a blood vessel is arranged in the length direction of the sacculus, and the wall thickness of the bending ring is smaller than that of a sacculus sac body outside the bending ring.

The application provides a balloon catheter's beneficial effect lies in: compared with the prior art, aiming at the characteristics of the bending vascular lesion, the balloon catheter is provided with the balloon and the inner tube arranged inside the balloon, wherein the tensile modulus of the inner tube is greater than that of the balloon, the balloon is provided with one or more bending rings which are used as bending nodes when the balloon is bent along the blood vessel in the length direction, and the wall thickness of each bending ring is less than that of the balloon except the bending ring. The deformation quantity of the length direction of the inner tube is smaller than that of the balloon when the balloon is expanded at the target blood vessel position, the two ends of the balloon are fixed on the inner tube, so that the balloon is bent, the balloon is subjected to axial uneven extrusion force from the inner wall of the blood vessel at the moment, and the balloon can effectively conform to the bending direction of the blood vessel to be bent in a self-adaptive manner, so that the blood vessel is prevented from being damaged, and the clinical risk is reduced. The balloon catheter provided by the application is simple in structure and easy to realize, the using method of the balloon catheter is the same as that of a common balloon, and the balloon catheter is easy to operate and apply in an operation.

The structure of the bending ring is improved, the wall thickness of the bending ring is 70% -90% of that of the balloon body outside the bending ring, so that a thin wall thickness area on the balloon body is formed, the thin wall thickness area is easier to bend and deform relative to a normal wall thickness area on the balloon body, and the bending effect of the balloon following the bending of blood vessels is further enhanced.

Optionally, the width of the bending ring is 1-5mm, which occupies less and short balloon surface area and is therefore not affected by the dilatation performance of the balloon itself.

The structure of the balloon catheter is improved, and the tensile modulus of the inner tube is 5% -20% higher than that of the balloon, so that the elastic modulus of the inner tube is higher when the inner tube is stressed, and the inner tube is not easy to deform in a stretching manner, and the balloon can effectively conform to the bending shape of a blood vessel to deform in an automatically adaptive bending manner.

Optionally, the balloon is made of a composite material. The balloon may preferably be made of a nylon material, and the characteristics of the nylon material are utilized to ensure the structural strength and the expandability of the balloon.

The overall structure of the balloon catheter is improved, the balloon catheter further comprises a main catheter and a guiding head arranged at the front end of the balloon catheter, and the guiding head is connected with one end of the balloon; the main catheter is connected with the other end of the sacculus, and the inner tube is arranged in the main catheter and penetrates through the two ends of the sacculus to be connected with the guiding head. The balloon can be ensured to move to the lesion part smoothly by utilizing the conductivity of the guide head in the blood vessel, and the passing performance of the balloon in the blood vessel is effectively improved.

Optionally, the bending ring is disposed in the middle of the balloon in the length direction, so that the balloon is folded by the bending ring into a first balloon section and a second balloon section, the first balloon section and the guide head are connected, and the second balloon section and the main catheter are connected. Because the bending ring is arranged in the middle of the balloon to divide the balloon into the first balloon section and the second balloon section with the same length, the balloon can be expanded to a lesion part uniformly after being expanded, the balloon can be positioned at the lesion part conveniently, and the displacement caused by the uneven expansion force is avoided.

Optionally, a plurality of the bending rings are uniformly distributed in the length direction of the balloon, so that the balloon is divided into a plurality of balloon sections by the bending rings, and the plurality of balloon sections include a first balloon section connected with the guiding head, a second balloon section connected with the main catheter, and at least one third balloon section between the first balloon section and the second balloon section. The balloon is divided into a plurality of balloon sections by utilizing the bending rings, so that the balloon is favorably applied to the complicated bending shape of the blood vessel to perform corresponding multi-node bending deformation, the compliance of the complicated blood vessel part is effectively matched, and the adaptability of the balloon catheter is improved.

Drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed to be used in the embodiments or the prior art descriptions will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present application, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without inventive exercise.

FIG. 1 is a schematic view of a prior art balloon catheter configuration;

FIG. 2 is a schematic structural view of a first embodiment of a balloon catheter provided in an example of the present application;

fig. 3 is a schematic structural diagram of a second embodiment of a balloon catheter provided in an example of the present application.

Wherein, in the figures, the respective reference numerals:

1-a balloon; 11-a first balloon segment; 12-a second balloon segment; 13-a third balloon segment;

2-inner tube; 3-bending the ring; 4-a main conduit; 5-guiding head.

Detailed Description

In order to make the technical problems, technical solutions and advantageous effects to be solved by the present application clearer, the present application is further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the present application and are not intended to limit the present application.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or be indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or be indirectly connected to the other element.

It will be understood that the terms "length," "width," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like, as used herein, refer to an orientation or positional relationship indicated in the drawings that is solely for the purpose of facilitating the description and simplifying the description, and do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus should not be considered as limiting the present application.

Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present application, "a plurality" means two or more unless specifically limited otherwise.

Referring to fig. 2 and 3 together, a balloon catheter with an adaptive bending function according to an embodiment of the present application will be described. The balloon catheter is provided with a strip-shaped balloon 1 and an inner tube arranged in the balloon 1, two ends of the balloon 1 are respectively fixed on the inner tube 2, and the tensile modulus of the inner tube 2 is larger than that of the balloon 1; at least one section of bending ring 3 used as a bending node when the sacculus 1 is bent along a blood vessel is arranged in the length direction of the sacculus 1, and the wall thickness of the bending ring 3 is smaller than that of the sacculus 1 except the bending ring 3.

Compared with the prior art, the balloon catheter provided by the application has the advantages that the balloon catheter is provided with the balloon 1 and the inner tube 2 in the balloon 1 according to the characteristics of the bent vascular lesions, on one hand, the tensile modulus of the inner tube 2 is larger than that of the balloon 1, specifically, the tensile modulus of the inner tube 2 can be preferably set to be higher than that of the balloon 1 by 5% -20%, so that the elastic modulus of the inner tube 2 under normal stress is higher, the balloon catheter is not prone to tensile deformation, and the balloon 1 can effectively conform to the bent shape of a blood vessel and is subjected to automatic adaptive bending deformation. On the other hand, one or two sections of bending rings 3 with a small wall thickness are arranged in the length direction of the balloon 1, and the bending rings 3 are used as bending nodes when the balloon 1 is bent to conform to a blood vessel. When the balloon 1 is expanded at the target blood vessel position, the deformation amount of the inner tube 2 in the length direction is smaller than that of the balloon 1 in the length direction, and two ends of the balloon 1 are fixed on the inner tube 2, so that the balloon 1 is inevitably bent; at this time, the balloon 1 receives an axially uneven pressing force from the inner wall of the blood vessel, so that the balloon 1 is adaptively bent in conformity with the bending direction of the blood vessel.

The wall thickness of the bending ring 3 on the balloon 1 is thinner than that of the balloon body of the balloon 1 except the bending ring 3, so that the balloon is easier to bend and deform, and the balloon 1 can conform to the bending of the blood vessel to generate a bending effect. Moreover, the width of the thin-walled bending ring 3 on the balloon 1 is small and short, and the bending ring can be set at 1-5mm, so the self-expansion performance of the balloon 1 is not affected.

The wall thickness of the bending ring 3 is preferably 70% -90% of the wall thickness of the balloon body of the balloon 1 except the bending ring 3, so that a region with a thinner wall thickness formed on the balloon body of the balloon 1 is easier to bend and deform relative to a normal wall thickness region on the balloon body of the balloon 1, and further the bending effect of the balloon 1 following the bending of a blood vessel is enhanced.

Example 1:

referring to fig. 2, the balloon 1 is made of a composite material, and nylon can be preferably used as the material of the balloon 1 to prepare the balloon 1, so as to ensure the structural strength and the expandability of the balloon 1 by utilizing the characteristics of the nylon material. The inner tube 2 is selected accordingly to have a tensile modulus of 20% higher than that of the balloon 1, and the balloon catheter is further provided with a visualization ring (not shown) for displaying the position of the balloon 1 in the blood vessel. The balloon catheter comprises a main catheter 4, a guide head 5 and a catheter seat (not shown), wherein the main catheter 4 is connected with the rear end part of the balloon 1. The inner tube 2 is sleeved in the main catheter 4 and penetrates through the two ends of the saccule 1 to be connected with the guide head 5. The guide head 5 is provided at the tip of the balloon catheter and connected to the tip of the balloon 1. The middle part of the balloon 1 is provided with a bending ring 3 with the width of 1mm, the wall thickness of the bending ring 3 is set to be 70% of that of the balloon body of the balloon 1 except the bending ring 3, so that the balloon 1 is divided into a first balloon section 11 and a second balloon section 12 which are the same in length and are arranged in front and at back by the bending ring 3, the balloon 1 can be expanded to a lesion part in a balanced manner after being expanded, the positioning of the balloon 1 at the lesion part is facilitated, and the phenomenon that the displacement is caused due to the uneven expansion force to cause the dislocation at a target position is avoided. Wherein, the first balloon section 11 is connected with the guiding head 5, and the second balloon section 12 is connected with the main catheter 4.

Before the balloon 1 is expanded, the bending ring 3 comprising the balloon 1, the inner tube 2 and the middle part of the balloon 1 is still straight. In the operation process of treating the bent narrow blood vessel, under the guidance of X-ray or ultrasound, the balloon 1 is positioned to the diseased blood vessel region by the guide head 5, the bending ring 3 of the balloon 1 is arranged at the bending part of the blood vessel, the balloon 1 is stretched and lengthened after expansion, the stretching deformation amount of the inner tube 2 is relatively small, therefore, a pulling force can be generated, the pulling force can enable the balloon 1 to have a bending tendency, and under the action of the axial extrusion force of the blood vessel, the balloon 1 can be bent along with the bending of the blood vessel. In practical application, the bending angle of the balloon 1 in the structure can exceed 45 degrees, so that the balloon 1 can expand and bend a diseased blood vessel without causing damage to the blood vessel due to forced straightening.

Example 2:

referring to fig. 3, nylon is continuously selected as the material of the balloon 1 to prepare the balloon 1, the inner tube 2 with a stretching modulus of 5% is correspondingly selected, and the balloon catheter is provided with a corresponding developing ring (not shown), a main catheter 4, a guide head 5 and a catheter seat (not shown) to prepare a complete balloon catheter. Two bending rings 3 with the width of 5mm are uniformly distributed in the length direction of the balloon 1, the bending rings 3 divide the balloon 1 into 3 parts, and the 3 parts comprise a first balloon section 11 connected with a guide head 5, a second balloon section 12 connected with a main catheter 4 and a third balloon section 13 between the first balloon section 11 and the second balloon section 12 so as to be used for carrying out corresponding multi-node bending deformation in a complex bending shape of a blood vessel, thereby effectively matching the compliance of a complex blood vessel part and improving the adaptability of the balloon catheter. The thickness of each bending ring 3 is 90% of the balloon thickness of the balloon 1 except the bending ring 3.

Before the balloon 1 is expanded, the balloon 1, the inner tube 2 and the respective bending loops 3 on the balloon 1 are still straight. In the operation process of treating the bent narrow blood vessel, under the guidance of X-ray or ultrasound, the balloon 1 is positioned to the diseased blood vessel region by the aid of the guide head 5, the bending ring 3 of the balloon 1 is arranged at the bent part of the blood vessel, the balloon 1 stretches and lengthens after expansion, and the stretching deformation amount of the inner tube 2 is relatively small, so that a pulling force can be generated, the pulling force can enable the balloon 1 to have a bending tendency, and the balloon 1 can be bent for multiple times along with the bending of the blood vessel under the action of the axial extrusion force of the blood vessel. When the saccule 1 expands and bends the diseased blood vessel, the blood vessel is not damaged due to forced straightening, and the clinical risk is reduced.

The above description is only exemplary of the present application and should not be taken as limiting the present application, as any modification, equivalent replacement, or improvement made within the spirit and principle of the present application should be included in the protection scope of the present application.

Claims

1. A balloon catheter with an adaptive bending function is characterized in that: the balloon catheter is provided with a strip-shaped balloon and an inner tube arranged in the balloon, two ends of the balloon are respectively fixed on the inner tube, and the tensile modulus of the inner tube is larger than that of the balloon; at least one section of bending ring used as a bending node when the sacculus is bent along a blood vessel is arranged in the length direction of the sacculus, and the wall thickness of the bending ring is smaller than that of a sacculus sac body outside the bending ring.

2. A balloon catheter with adaptive bending function according to claim 1, wherein: the wall thickness of the bending ring is 70% -90% of that of the balloon body outside the bending ring.

3. A balloon catheter with adaptive bending function according to claim 1, wherein: the width of the bending ring is 1-5 mm.

4. A balloon catheter with adaptive bending function according to claim 1, wherein: the tensile modulus of the inner tube is 5% -20% higher than that of the balloon.

5. A balloon catheter with adaptive bending function according to claim 1, wherein: the balloon is made of a composite material.

6. A balloon catheter with an adaptive bending function according to any one of claims 1 to 5, wherein: the balloon catheter also comprises a main catheter and a guide head arranged at the front end of the balloon catheter, and the guide head is connected with one end of the balloon; the main catheter is connected with the other end of the sacculus, and the inner tube is arranged in the main catheter and penetrates through the two ends of the sacculus to be connected with the guiding head.

7. The balloon catheter with adaptive bending function according to claim 6, wherein: the bending ring is arranged in the middle of the balloon in the length direction, so that the balloon is divided into a first balloon section and a second balloon section by the bending ring, the first balloon section and the guide head are connected, and the second balloon section and the main catheter are connected.

8. The balloon catheter with adaptive bending function according to claim 6, wherein: the balloon is characterized in that a plurality of bending rings are uniformly distributed in the length direction of the balloon, so that the balloon is divided into a plurality of balloon sections by the bending rings, and the balloon sections comprise a first balloon section connected with the guiding head, a second balloon section connected with the main catheter and at least one third balloon section between the first balloon section and the second balloon section.