WO2025167704A1 - Dilation balloon and dilation balloon assembly - Google Patents

Abstract

A dilation balloon and a dilation balloon assembly. The dilation balloon comprises a balloon body (1). The balloon body (1) comprises an inner layer (110) and an outer layer (120). The balloon body (1) can dilate or retract along with an internal filling medium. In the dilation process of the balloon body (1), the outer layer (120) can abut against an inner wall of a blood vessel and dilate the blood vessel along with the dilation of the balloon body (1), and can move in the blood vessel when the balloon body (1) retracts. The inner layer (110) is a non-compliant layer, and the outer layer (120) is a compliant layer.

Description

Dilatation balloon and dilatation balloon assembly

CROSS-REFERENCE TO RELATED APPLICATIONS

This disclosure claims priority to a Chinese patent application filed with the Patent Office of China on February 6, 2024, with application number 202410171884.0 and titled “Expansion Balloon and Expansion Balloon Assembly,” the entire contents of which are incorporated by reference into this disclosure.

Technical Field

The present disclosure relates to the technical field of medical devices, and in particular, to an expansion balloon and an expansion balloon assembly.

Background Art

Balloon catheter dilatation is widely used in the treatment of vascular stenosis and other lesions. In related technologies, in order to make the dilatation balloon have a higher radial support force, the dilatation balloon usually adopts a non-compliant balloon, and the non-compliant balloon usually needs to be pre-pressed and folded. After the folded balloon is sent to the lesion site, the balloon is pressurized to expand the balloon to achieve the expansion treatment of the stenotic lesion site. However, during the above-mentioned non-compliant balloon dilatation process, since the folded balloon is usually in a multi-layer folded state, as the pressurization operation causes the balloon to continue to expand, a rotation effect will be generated when the layers unfold, which can easily cause the formation of dissections in the blood vessels.

Summary of the Invention

The purpose of the present disclosure is to provide an expansion balloon and an expansion balloon assembly, which can achieve uniform expansion of the inner wall of the blood vessel, avoid tearing of the inner wall of the blood vessel at a local position, and effectively reduce the risk of vascular dissection.

In order to achieve the above-mentioned purpose, the first aspect of the present disclosure provides an expansion balloon, which includes a balloon body, and the balloon body includes an inner layer and an outer layer. The balloon body can expand or retract as the internal filling and release medium is filled or released. During the expansion of the balloon body, the outer layer can be pressed against the inner wall of the blood vessel and expand the blood vessel as the balloon body expands. When the balloon body retracts, it can move in the blood vessel, wherein the inner layer is a non-compliant layer and the outer layer is a compliant layer.

Optionally, the balloon body further includes a transition layer arranged between the inner layer and the outer layer.

Optionally, the transition layer is filled with lubricating liquid.

Optionally, the outer layer includes a first compliance layer located on the inner side and a second compliance layer located on the outer side, and a hard point structure is arranged between the first compliance layer and the second compliance layer. As the balloon body expands, the wall surface of the second compliance layer expands and becomes thinner. The hard point structure can lift up part of the wall surface of the second compliance layer so that a bulge is formed on the second compliance layer for pressing against the inner wall of the blood vessel.

Optionally, there are multiple hard point structures and they are arranged in an array.

Optionally, the distance between any two adjacent hard point structures among the multiple hard point structures is the same.

Optionally, the hard point structure and the first compliant layer are integrally formed by polymer material.

Optionally, one end of the hard point structure close to the second compliant layer is arc-shaped.

Optionally, the expansion balloon further includes a connecting catheter, one end of which is surrounded by the balloon body, for filling or releasing a medium into the balloon body through the connecting catheter.

A second aspect of the present disclosure further provides an expansion balloon assembly, which includes a syringe and the expansion balloon as described above, wherein the syringe is used to fill or release a medium into the balloon body.

The above-described technical solution, namely, the dilatation balloon provided by the present disclosure, is configured to expand or contract as the internal medium is filled or released. Thus, in vascular dilatation treatment, for example, dilatation treatment can be performed on stenotic lesions within a vessel. Furthermore, by arranging the inner and outer layers of the balloon body as non-compliant and compliant layers, respectively, the compliant layer adheres to the vessel's inner wall after the balloon body is inflated and abuts against the vessel's inner wall. This allows the compliant layer to expand uniformly and without rotation during the balloon body's inflation process, facilitating uniform force distribution on the vessel's inner wall and preventing localized tearing of the vessel's inner wall, effectively reducing the risk of vascular dissection. Furthermore, the non-compliant inner layer provides a greater radial support force when the balloon body abuts against the vessel's inner wall, thereby enhancing the dilatation treatment efficacy of the dilatation balloon for stenotic lesions within the vessel.

Other features and advantages of the present disclosure will be described in detail in the following detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are used to provide a further understanding of the present disclosure and constitute a part of the specification. Together with the following detailed description, they are used to explain the present disclosure but do not constitute a limitation of the present disclosure. In the accompanying drawings:

FIG1 is a schematic diagram of the structure of an expansion balloon placed on the inner wall of a blood vessel in the related art;

FIG2 is a cross-sectional view taken along line A-A in FIG1 ;

FIG3 is a schematic structural diagram of an expansion balloon provided in an exemplary embodiment of the present disclosure when it is retracted;

FIG4 is a partial enlarged schematic diagram of position B in FIG3 ;

FIG5 is a schematic structural diagram of an expansion balloon provided in an exemplary embodiment of the present disclosure when inflated;

FIG6 is a partial enlarged schematic diagram of position C in FIG5 ;

FIG7 is a schematic structural diagram of an expansion balloon provided in an exemplary embodiment of the present disclosure placed on the inner wall of a blood vessel.

Description of Reference Numerals
1-Balloon body; 110-Inner layer; 120-Outer layer; 121-First compliance layer; 122-Second compliance layer; 123-Bump; 130-Transition layer; 2-Lubricating fluid; 3-Hard point structure; 4-Inner wall of blood vessel; 5-Connecting catheter; 510-First inlet; 6-Non-compliant balloon.

DETAILED DESCRIPTION

The following describes the specific embodiments of the present disclosure in detail with reference to the accompanying drawings. It should be understood that the specific embodiments described herein are only used to illustrate and explain the present disclosure and are not intended to limit the present disclosure.

In this disclosure, unless otherwise indicated, "inside" and "outside" refer to the inside and outside relative to the outline of a component or structure. Furthermore, it should be noted that the use of terms such as "first" and "second" is intended to distinguish one element from another and does not imply order or importance. Furthermore, in the description with reference to the accompanying drawings, the same reference numerals in different drawings represent the same element.

In the related art, as shown in Figures 1 and 2, in order to provide a high radial support force for the expansion balloon, a non-compliant balloon 6 is typically used. Furthermore, the non-compliant balloon 6 is typically pre-pressed and folded to facilitate delivery of the expansion balloon to, for example, a stenotic lesion within a blood vessel. After the folded balloon is delivered to the lesion, pressurization is applied to the balloon, causing it to expand outward, for example, as indicated by arrow D, thereby expanding the stenotic lesion. However, as shown in Figure 2, during the expansion of the non-compliant balloon 6, since the folded balloon is typically multi-layered, the layers of the balloon will rotate as the pressurization operation continues to expand. This rotational effect, as the layers of the balloon continue to expand, creates shear stress in the direction of arrow E, for example. This shear stress can easily cause the portion of the non-compliant balloon 6 that contacts the inner wall 4 of the blood vessel to scrape against the inner wall 4, causing localized tearing of the inner wall 4 and potentially leading to the risk of vascular dissection.

Based on this, according to the first aspect of the present disclosure, an expansion balloon is provided, as shown in Figures 3 to 7, the expansion balloon includes a balloon body 1, and the balloon body 1 includes an inner layer 110 and an outer layer 120. The balloon body 1 can expand or retract as the internal filling and releasing medium is filled or released. During the expansion of the balloon body 1, the outer layer 120 can be pressed against the inner wall 4 of the blood vessel and expand the blood vessel as the balloon body 1 expands. When the balloon body 1 retracts, it can move in the blood vessel, wherein the inner layer 110 is a non-compliant layer and the outer layer 120 is a compliant layer.

The above-described technical solution, i.e., the dilatation balloon provided by the present disclosure, is configured to expand or contract as the internal medium is filled or released. Thus, in vascular dilatation treatment, for example, dilatation treatment can be performed at the location of vascular stenosis. Furthermore, by arranging the inner layer 110 and outer layer 120 of the balloon body 1 as a non-compliant layer and a compliant layer, respectively, the compliant layer can adhere to the inner wall 4 of the vessel when the balloon body 1 is inflated and abuts against the inner wall of the vessel. This allows the compliant layer to expand uniformly and not rotate during the inflation process of the balloon body 1, thereby facilitating uniform force application to the inner wall 4 of the vessel, preventing localized tearing of the inner wall 4 and effectively reducing the risk of vascular dissection. Furthermore, since the inner layer 110 is configured as a non-compliant layer, the non-compliant layer can provide a greater radial support force when the balloon body 1 abuts against the inner wall 4 of the vessel, thereby enhancing the dilatation treatment effect of the dilatation balloon on vascular stenosis.

Among them, it should be noted that the above-mentioned compliance layer can be a polymer material such as polyvinyl chloride (PVC), that is, it can be understood that the expansion effect of the compliance layer is similar to the expansion of a balloon. This is conducive to ensuring that the compliance layer expands evenly after the balloon body 1 is inflated and no rotation effect is produced, so that the inner wall 4 of the blood vessel is evenly stressed, avoiding tearing at local positions of the inner wall 4 of the blood vessel, and effectively reducing the risk of vascular dissection. Furthermore, considering that the material of the compliance layer is relatively soft, the radial support force provided during the expansion process of the expansion balloon is relatively small. Therefore, the present disclosure constructs the inner layer 110 of the balloon body 1 located inside the outer layer 120 as a non-compliant layer. For example, the non-compliant layer can be a polymer material such as polyethylene (PE), polyurethane or nylon (Nylon, DuralynTM). Since the non-compliant layer itself is relatively hard compared to the compliant layer, it can provide a larger radial support force, thereby improving the expansion treatment effect of the expansion balloon on the stenosis in the blood vessel. At the same time, since the compliant layer is coated on the outside of the non-compliant layer, it can also avoid, for example, the related technology of directly contacting the non-compliant layer with the inner wall 4 of the blood vessel to avoid tearing at a local position of the inner wall 4 of the blood vessel, thereby effectively reducing the risk of vascular dissection.

Of course, it should be noted that the specific embodiments of the compliant layer and the non-compliant layer described above are merely exemplary. In other embodiments, those skilled in the art may also adaptively design the compliant layer and the non-compliant layer according to actual application requirements. The purpose is to ensure that the expansion balloon can stably expand the inner wall 4 of the blood vessel and to evenly apply force to the inner wall 4 of the blood vessel, thereby avoiding localized tearing of the inner wall 4 of the blood vessel and reducing the risk of vascular dissection. The present disclosure is not limited thereto.

In some embodiments, as shown in Figures 3 to 7, the balloon body 1 may further include a transition layer 130 arranged between the inner layer 110 and the outer layer 120. In this way, not only can the inner layer 110 and the outer layer 120 be stably connected, but the friction between the inner layer 110 and the outer layer 120 during the inflation of the balloon body 1 can also be reduced, so that the balloon body 1 can expand evenly, avoiding tearing at local positions of the inner wall 4 of the blood vessel, and effectively reducing the risk of vascular dissection.

It should be noted that the inner layer 110, outer layer 120, and transition layer 130 can be fixedly connected by, for example, bonding, which provides a simple structure and high reliability. Of course, in other embodiments, the inner layer 110, outer layer 120, and transition layer 130 can also be integrally formed, for example, by 3D printing. This disclosure does not specifically limit such a deformation method. Those skilled in the art can adapt the design based on actual application requirements, as long as the inner layer 110, outer layer 120, and transition layer 130 are stably connected. This disclosure is not limited to this.

Optionally, in some embodiments, as shown in Figures 3 to 6, the transition layer 130 can be filled with a lubricating liquid 2. This not only further reduces the friction between the inner layer 110 and the outer layer 120, but also allows the lubricating liquid 2 to act as a buffer, thereby ensuring uniform expansion of the inner wall 4 of the blood vessel, avoiding tearing at local locations of the inner wall 4 of the blood vessel, and effectively reducing the risk of vascular dissection.

The lubricating liquid 2 may be a buffer solution such as a phosphate solution, a borate solution, or a carbonate solution. This disclosure does not specifically limit this. Those skilled in the art may adaptably design the lubricating liquid according to actual application requirements. The purpose is to reduce friction between the inner layer 110 and the outer layer 120, allowing the balloon body 1 to expand uniformly and reducing the risk of vascular dissection. This disclosure is not limited thereto.

In some embodiments, as shown in FIG3 to FIG7, the outer layer 120 may include a first compliance layer 121 located on the inner side and a second compliance layer 122 located on the outer side, and considering that when the compliance layer of the balloon body 1 abuts against the inner wall 4 of the blood vessel, it directly contacts the inner wall 4 of the blood vessel through the compliance layer, and the friction between the compliance layer and the inner wall 4 of the blood vessel is small, which is easy to cause scratching, causing the inner wall 4 of the blood vessel to tear at a local position, which is easy to cause the risk of vascular dissection. Therefore, the present disclosure provides a method for forming a first compliance layer 121 and a second compliance layer 122 on the outer side of the balloon body 1. A hard point structure 3 can be provided between 22, so that as the balloon body 1 expands, the wall surface of the second compliance layer 122 continues to expand and thin. The hard point structure 3 can lift up part of the wall surface of the second compliance layer 122, so that a convex point 123 for pressing against the inner wall 4 of the blood vessel is formed on the second compliance layer 122, thereby increasing the friction between the compliance layer and the inner wall 4 of the blood vessel, avoiding the problem of scratching and tearing at a local position of the inner wall 4 of the blood vessel due to low friction, and effectively reducing the risk of vascular dissection.

In addition, when the balloon body 1 is retracted, the hard point structure 3 can also be hidden between the first compliance layer 121 and the second compliance layer 122, so as to facilitate the delivery of the balloon body 1 of the expanded balloon to the location of the stenosis in the blood vessel. At the same time, since the hard point structure 3 can be hidden between the first compliance layer 121 and the second compliance layer 122, the risk of scratching the inner wall 4 of the blood vessel during the delivery of the balloon body 1 is also avoided.

Optionally, in some embodiments, as shown in Figures 3 to 7 , the number of hard point structures 3 can be multiple and arranged in an array. This can further increase the friction between the compliant layer and the inner wall 4 of the blood vessel, avoiding the problem of scratching and tearing of the inner wall 4 due to low friction, effectively reducing the risk of vascular dissection. The multiple hard point structures 3 can be arranged at intervals in a rectangular array and/or an annular array, for example. This disclosure does not specifically limit such deformation methods, and those skilled in the art can adapt the design according to actual application requirements.

In addition, in some embodiments, as shown in Figures 3 to 7, the spacing between any two adjacent hard point structures 3 among the multiple hard point structures 3 can be the same, which can help ensure uniform force on the inner wall 4 of the blood vessel and effectively reduce the risk of vascular dissection.

In addition, in some embodiments, the hard point structure 3 can be integrally formed with the first compliant layer 121 through a polymer material. For example, the hard point structure 3 can be a relatively hard polymer material such as polyethylene (PE), polyurethane or nylon (Nylon, DuralynTM), and can be integrally formed with the first compliant layer 121 through methods such as 3D printing. The structure is simple and easy to form and prepare.

Of course, it should be noted that the aforementioned method of integrally forming the hard point structure 3 with the first compliant layer 121 is merely exemplary. In other embodiments, the hard point structure 3 may also be fixedly connected to the first compliant layer 121 by, for example, laser welding or hot melt welding. This disclosure does not specifically limit this method of deformation, and those skilled in the art may adaptably design it according to actual application requirements. This disclosure is not limited to this.

In addition, in some embodiments, as shown in Figures 4 and 6 , the end of the hard point structure 3 near the second compliant layer 122 can be arc-shaped. This allows for greater friction between the compliant layer and the inner wall 4 of the blood vessel while also preventing the inner wall 4 from being scratched, thereby improving the dilation effect of the balloon on vascular stenosis. Figures 4 and 6 both exemplify that the outer contour of the hard point structure 3 can be hemispherical, which is simple and easy to manufacture. Of course, it should be noted that those skilled in the art can also adapt the specific outer contour of the hard point structure 3 to actual application requirements, and the present disclosure is not limited thereto.

In some embodiments, as shown in FIG3 to FIG7 , the expansion balloon may further include a connecting catheter 5, one end of which is surrounded by a balloon body 1, so that the medium can be filled and discharged into the balloon body 1 through the connecting catheter 5. The connection catheter 5 has good controllability and a simple structure. At the same time, the connecting catheter 5 can also facilitate the delivery of the expansion balloon to the location of the stenosis in the blood vessel. It should be noted that in order to more accurately deliver the expansion balloon to the location of the stenosis in the blood vessel, those skilled in the art can use, for example, angiography technology known in the art to deliver the expansion balloon to the corresponding location of the stenosis in the blood vessel. Angiography technology is a well-known technical means in the art, and the present disclosure will not elaborate on it in detail. Its purpose is to be able to deliver the expansion balloon to the location of the stenosis in the blood vessel.

In addition, it should be noted that the above-mentioned medium can be, for example, a gas medium or a liquid medium. Its purpose is to be able to achieve the expansion of the balloon body 1 by filling the medium into the balloon body 1. The present disclosure does not specifically limit this type of deformation method, and those skilled in the art can adaptively design it according to actual application requirements.

Alternatively, in some embodiments, the balloon body 1 can be adhesively connected to the connecting catheter 5, which simplifies the structure and facilitates installation. Of course, in other embodiments, the balloon body 1 can also be sealed and sutured to the connecting catheter 5. This disclosure does not specifically limit such deformation methods, as long as the purpose is to achieve a stable connection between the connecting catheter 5 and the balloon body 1. This disclosure is not limited to this.

In addition, it should be noted that the material and specific molding process of the connecting conduit 5 are not specifically limited in this disclosure. Those skilled in the art can adaptably design the connecting conduit 5 according to actual application requirements. For example, the connecting conduit 5 can be made of nylon, polyethylene terephthalate, or polyurethane; and the connecting conduit 5 can be manufactured by, for example, integral stretch blow molding or 3D printing. This disclosure is not limited thereto.

In addition, in some embodiments, as shown in Figures 3 to 6, the connecting catheter 5 can also be provided with a first inlet 510 that is connected to the interior of the balloon body 1, so that after the operator delivers the expansion balloon to the stenotic lesion site in the blood vessel, the medium can be filled or released into the balloon body 1 through the first inlet 510 of the connecting catheter 5, thereby achieving expansion treatment of the stenosis in the blood vessel by the expansion balloon.

In addition, it should be noted that the lubricating liquid 2 in the above-mentioned transition layer 130 can be pre-sealed in the transition layer 130, or a second inlet (not shown in the figure) connected to the transition layer 130 can be provided on the connecting conduit 5, so that the lubricating liquid 2 can be filled and discharged into the transition layer 130 through the connecting conduit 5. At the same time, the connecting conduit 5 can also be provided with an outlet (not shown in the figure) connected to the transition layer 130. In this way, while the operator continuously fills the transition layer 130 with the lubricating liquid 2 through the second inlet, the gas in the transition layer 130 can be discharged through the outlet, which facilitates the filling operation of the lubricating liquid 2 and has good controllability.

It should be noted that the present disclosure does not specifically limit the specific position and opening size of the second inlet and outlet on the connecting conduit 5. Those skilled in the art can adaptively design it according to actual application requirements. The purpose is to facilitate the filling and discharge of the lubricating liquid 2 inside the transition layer 130 through the connecting conduit 5.

According to the second aspect of the present disclosure, an expansion balloon assembly is also provided, which includes a syringe (not shown in the figure) and the above-mentioned expansion balloon. The head of the syringe can be adapted to the connecting catheter 5, so that the syringe can be used to fill and discharge the medium into the balloon body 1. The expansion balloon assembly can be used in scenarios such as the treatment of lesions such as vascular stenosis, so that the expansion balloon of the expansion balloon assembly can be placed at the location of the stenosis lesion in the blood vessel, thereby achieving expansion treatment of the stenosis in the blood vessel through the inflation of the expansion balloon. It has good controllability and can avoid causing tearing at a local location of the inner wall of the blood vessel, effectively reducing the risk of vascular dissection. In addition, the expansion balloon assembly also has all the beneficial effects of the above-mentioned expansion balloon, which will not be repeated in this disclosure.

In addition, it should be noted that the specific structure of the above-mentioned syringe and the specific connection method with the connecting catheter 5 are not specifically limited in this disclosure. The purpose is to be able to use the syringe to fill and release the medium into the balloon body 1 of the expansion balloon. Those skilled in the art can adaptively design it according to actual application requirements.

The preferred embodiments of the present disclosure are described in detail above in conjunction with the accompanying drawings. However, the present disclosure is not limited to the specific details of the above embodiments. Within the technical concept of the present disclosure, various simple modifications can be made to the technical solutions of the present disclosure, and these simple modifications all fall within the scope of protection of the present disclosure.

It should also be noted that the various specific technical features described in the above specific embodiments can be combined in any suitable manner without contradiction. To avoid unnecessary repetition, the present disclosure will not further describe various possible combinations.

In addition, the various embodiments of the present disclosure may be arbitrarily combined, and as long as they do not violate the concept of the present disclosure, they should also be regarded as the contents disclosed by the present disclosure.

Claims (10)

An expansion balloon, characterized in that the expansion balloon comprises a balloon body (1), the balloon body (1) comprises an inner layer (110) and an outer layer (120), the balloon body (1) can expand or retract as the internal filling and releasing medium is applied, during the expansion of the balloon body (1), the outer layer (120) can abut against the inner wall (4) of the blood vessel and expand the blood vessel as the balloon body (1) expands, and can move within the blood vessel when the balloon body (1) retracts, wherein the inner layer (110) is a non-compliant layer, and the outer layer (120) is a compliant layer. The expansion balloon according to claim 1 is characterized in that the balloon body (1) further includes a transition layer (130) arranged between the inner layer (110) and the outer layer (120). The expansion balloon according to claim 2, characterized in that the transition layer (130) is filled with lubricating liquid (2). The expansion balloon according to any one of claims 1 to 3 is characterized in that the outer layer (120) includes a first compliance layer (121) located on the inner side and a second compliance layer (122) located on the outer side, and a hard point structure (3) is provided between the first compliance layer (121) and the second compliance layer (122). As the balloon body (1) expands, the wall surface of the second compliance layer (122) expands and becomes thinner, and the hard point structure (3) can lift part of the wall surface of the second compliance layer (122) so that a convex point (123) for pressing against the inner wall (4) of the blood vessel is formed on the second compliance layer (122). The expansion balloon according to claim 4 is characterized in that the hard point structures (3) are multiple in number and arranged in an array. The expansion balloon according to claim 5 is characterized in that the distance between any two adjacent hard point structures (3) among the multiple hard point structures (3) is the same. The expansion balloon according to claim 4, characterized in that the hard point structure (3) and the first compliance layer (121) are integrally formed by polymer material. The expansion balloon according to claim 4, characterized in that the end of the hard point structure (3) close to the second compliance layer (122) is arc-shaped. The expansion balloon according to claim 1 is characterized in that the expansion balloon further comprises a connecting catheter (5), one end of which is surrounded by the balloon body (1) for filling and releasing a medium into the balloon body (1) through the connecting catheter (5). An expansion balloon assembly, characterized in that it comprises a syringe and the expansion balloon according to any one of claims 1 to 9, wherein the syringe is used to fill or release a medium into the balloon body (1).