A balloon for a catheter and a balloon dilatation catheter

Abstract

The present invention relates to a catheter balloon and a balloon dilation catheter. The balloon comprises an expandable or contractible balloon body, a plurality of coils connected to the balloon body and distributed around the axis of the balloon body, the coils having a shape memory function and being able to be induced to switch between an initial state and a deformed state. When the balloon body expands, the coils tend to expand outward under the drive and / or induction of the balloon body; when the balloon body contracts, the coils can be induced to return from the deformed state of expanding outward to the initial state, and drive the balloon body to rotate around the axis of the balloon body to form a plurality of coiled petals. The present invention forms a plurality of coiled petals when the balloon body contracts by driving the coils, thereby returning the balloon to its initial folded state, facilitating balloon withdrawal, while reducing the risk of the balloon scratching the inner wall of the blood vessel and improving patient comfort.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a balloon for a catheter and a balloon dilation catheter. Background Art

[0002] A balloon dilatation catheter is a medical device commonly used to treat coronary artery disease. It inserts an inflatable balloon into a narrowed or blocked blood vessel and then inflates it by pressurizing it, thereby dilating the vessel and restoring blood flow. However, due to limitations in existing materials and processes, traditional balloon dilatation catheters often struggle to rewind in their original folding configuration after deflation. Consequently, they often form two flat petals, which are significantly larger than the original multi-petal balloon. This not only complicates product retraction into the sheath but can also cause scratches on the vessel wall, impacting patient comfort. Summary of the Invention

[0003] An object of the present invention is to provide a catheter balloon and a balloon dilatation catheter that can be rolled up when deflated.

[0004] In order to achieve the above object, the technical solution adopted by the present invention is:

[0005] A catheter balloon comprises an expandable or contractible balloon body, and a plurality of windings connected to the balloon body and distributed around the axis of the balloon body, wherein the windings have a shape memory function and can be induced to switch between an initial state and a deformed state.

[0006] When the balloon body is expanded, the winding member has a tendency to expand outwards under the drive of the balloon body and / or the induction;

[0007] When the balloon body contracts, the winding member can recover from the outwardly expanded deformation state to the initial state under the induction, and drive the balloon body to rotate around the axis of the balloon body to form a plurality of wound petals.

[0008] Preferably, the winding member includes a winding portion and two connecting portions respectively provided at both ends of the winding portion, the winding portion is connected to the balloon body and when the balloon body contracts, the winding portion supports the balloon body to form the valve body.

[0009] In some embodiments, the winding portion includes a main body segment connected to the balloon body and extending axially along the balloon body, and two deformable segments symmetrically arranged at both ends of the main body segment and bent. When the winding member switches from a deformed state to an initial state, the deformable segment drives the main body segment to wind inward.

[0010] In some embodiments, the connecting segment is spiral-shaped.

[0011] Preferably, the winding member is formed by bending a metal wire.

[0012] Preferably, the winding member is made of nickel-titanium alloy.

[0013] Preferably, a developing layer is coated on the outside of the winding member.

[0014] In some embodiments, the developing layer is a tantalum layer.

[0015] Preferably, the balloon body includes an outer balloon and an inner balloon connected to the inner side of the outer balloon, and the winding member is arranged between the inner balloon and the outer balloon and fits tightly with both.

[0016] Preferably, the induction includes thermal induction, and when the temperature of the winding member is greater than or equal to the set temperature, the winding member has a tendency to transform to the initial state; when the temperature of the winding member is less than the set temperature, the winding member has a tendency to transform to the deformed state.

[0017] Preferably, the set temperature is not greater than human body temperature.

[0018] More preferably, the set temperature is 30±3°C.

[0019] The present invention also provides a balloon dilatation catheter, comprising the catheter balloon described above.

[0020] Preferably, the balloon dilatation catheter also includes an operating handle and an inner tube and an outer tube connected to the operating handle, the inner tube is inserted into the balloon body and the distal end is connected to the distal end of the balloon body, the outer tube is sleeved on the outside of the inner tube and the distal end is inserted into the balloon body and connected to the proximal end of the balloon body, a flow chamber for circulation of inflation medium and connected to the balloon body is formed between the inner tube and the outer tube, the operating handle has a filling chamber connected to the flow chamber and a guidewire chamber connected to the inner tube and for inserting a guidewire.

[0021] The present invention also provides a folding method for a catheter balloon as described above, comprising releasing the expansion medium in the balloon body, heating the balloon, inducing the winding member to switch to an initial state to drive the winding member to rotate with the balloon body around its axis to form a plurality of wound petals.

[0022] Due to the application of the above technical solution, the present invention has the following advantages compared with the prior art:

[0023] The present invention provides a winding part with shape memory function on the balloon body. By inducing the deformation of the winding part, the balloon body is driven to form multiple winding petals when it contracts, which can restore the balloon to its initial folded state, facilitate the withdrawal of the balloon, and at the same time reduce the scratching of the balloon on the inner wall of the blood vessel, thereby improving the comfort of the patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[0025] Figure 1 This is a half-cross-sectional exploded view of the balloon in Example 1, wherein the balloon body is in an expanded state;

[0026] Figure 2 Schematic diagram of the structure of the balloon in Example 1, wherein the balloon body is in a contracted state and the winding member is in an expanded state;

[0027] Figure 3 for Figure 2 The balloon in the figure does not show the structural diagram of the balloon body;

[0028] Figure 4 This is a schematic structural diagram of the balloon in Example 1 in a folded state;

[0029] Figure 5 for Figure 4 The balloon in the figure does not show the structural diagram of the balloon body;

[0030] Figure 6 This is a schematic structural diagram of the winding member in Example 1 in an open state;

[0031] Figure 7 This is a structural schematic diagram of another angle of the winding member in Example 1 in an open state;

[0032] Figure 8 Schematic diagrams of the structure of the balloon in Example 1, wherein (a) is a schematic diagram of the structure of the winding member in an expanded state, (b) is a schematic diagram of the structure of the balloon body in a contracted state and the winding member in an expanded state, (c) is a schematic diagram of the structure of the winding member in an initial state, and (d) is a schematic diagram of the structure of the balloon body in a contracted state and the winding member in an initial state;

[0033] Figure 9 Schematic cross-sectional view of part of the balloon body and the winding member in Example 1;

[0034] Figure 10 Schematic diagram of the structure of the balloon dilatation catheter in Example 1;

[0035] Among them: 1. Balloon; 11. Balloon body; 111. Inner balloon; 112. Outer balloon; 12. Winding; 121. Main section; 122. Deformation section; 123. Connecting part; 2. Inner tube; 3. Outer tube; 4. Operating handle; 5. Guide wire. DETAILED DESCRIPTION

[0036] Hereinafter, only certain exemplary embodiments are briefly described. As will be appreciated by those skilled in the art, the described embodiments may be modified in various ways without departing from the spirit or scope of the embodiments of the present invention. Therefore, the drawings and description are to be regarded as illustrative in nature and not restrictive.

[0037] In describing the embodiments of the present invention, it should be understood that the terms "distal" and "proximal" and other terms referring to positions or locations are defined based on the orientation of the balloon dilatation catheter during use, with the side closest to the operator being the proximal end and the side away from the operator being the distal end. These terms are used solely for the purpose of facilitating the description of the embodiments of the present invention and simplifying the description. They do not indicate or imply that the devices or components referred to must have, be constructed, or operate in a specific orientation, and are therefore not to be construed as limiting the embodiments of the present invention.

[0038] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be understood to indicate or imply relative importance or implicitly specify the number of the technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of the embodiments of the present invention, "plurality" means two or more, unless otherwise specifically defined.

[0039] In the embodiments of the present invention, unless otherwise expressly specified or limited, a first feature being "above" or "below" a second feature may include the first and second features being in direct contact, or may include the first and second features being in contact not directly but through another feature between them. Moreover, a first feature being "above," "above," and "above" a second feature includes the first feature being directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature. A first feature being "below," "below," and "below" a second feature includes the first feature being directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.

[0040] The disclosure below provides many different embodiments or examples for implementing different structures of the embodiments of the present invention. In order to simplify the disclosure of the embodiments of the present invention, the components and configurations of specific examples are described below. Of course, these are merely examples and are not intended to limit the embodiments of the present invention. In addition, the embodiments of the present invention may repeat reference numerals and / or reference letters in different examples. Such repetition is for the purpose of simplicity and clarity and does not in itself indicate the relationship between the various embodiments and / or configurations discussed.

[0041] The embodiments of the present invention are described in detail below with reference to the accompanying drawings.

[0042] Example 1

[0043] A balloon dilatation catheter, such as Figure 10 As shown, it includes a balloon 1, a catheter assembly and an operating handle 4.

[0044] like Figures 1 to 9 As shown, the balloon 1 includes an expandable or contractible balloon body 11 and a winding member 12 connected to the balloon body 11. The winding members 12 are arranged uniformly around the axis of the balloon body 11. Each winding member 12 has a shape memory function and can be induced to switch between an initial state and a deformed state. When the balloon body 11 expands, the winding member 12 tends to expand outward under the drive and / or induction of the balloon body 11. When the balloon body 11 contracts, the winding member 12 can be induced to return from the outwardly expanded deformed state to the initial state and drive the balloon body 11 to rotate around the axis of the balloon body 11 to form multiple coiled petals. The provision of the winding member 12 allows the balloon body 11 to re-coil when the balloon 1 is withdrawn, thereby reducing the size of the balloon body 11 when contracted and facilitating the withdrawal of the balloon 1.

[0045] Each winding member 12 corresponds to a petal of the balloon body 11. Preferably, there are 2 to 5 winding members 12. In this embodiment, there are 3 winding members 12, that is, the balloon body 11 can be wound in a three-petal form. The following is a detailed discussion of one of the winding members 12.

[0046] The winding member 12 includes a winding portion and two connecting portions 123 respectively provided at two ends of the winding portion.

[0047] The winding portion supports the balloon body 11 to form the petal. Specifically, the winding portion includes a main section 121 connected to the balloon body 11 and extending axially along the balloon body 11, and two deformable sections 122 symmetrically arranged at both ends of the main section 121 and bent. The deformable sections 122 can be optionally connected to the balloon body 11. When the winding member 12 is transformed from an outwardly opened state to an initial state, the two deformable sections 122 arranged at both ends of the main section 121 are wound around the axial direction of the balloon body 11 and drive the main section 121 to move toward the direction close to the axis of the balloon body 11, thereby driving the balloon body 11 to wind; when the winding member 12 is transformed from the initial state to the deformed state, the deformable section 122 opens outward and drives the main section 121 to move toward the direction away from the axis of the balloon 1.

[0048] The connecting portion 123 is preferably in a spiral shape, as the spiral connecting portion 123 is more stable.

[0049] The connecting portion 123 is integrally formed with the winding portion and can be formed by bending a metal wire. The metal wire is an alloy with shape memory function, preferably a nickel-titanium alloy. Nickel-titanium alloy has excellent shape memory properties and can deform under thermal induction. By processing the winding member 12 made of nickel-titanium alloy wire, the specific processing method can refer to existing technologies, so that when the temperature of the winding member 12 is greater than or equal to the set temperature, the winding member 12 has a tendency to transition to the initial state; when the temperature of the winding member 12 is less than the set temperature, the winding member 12 has a tendency to transition to the deformed state. Preferably, the set temperature is no greater than human body temperature. Therefore, when the balloon 1 enters the human body, the winding member 12 can be heated to or above the set temperature under the influence of human body temperature. Then, when the expansion medium in the balloon body 11 is discharged, the winding member 12 can return to its initial state and drive the balloon body 12 to coil. In this embodiment, the set temperature is 30±3°C.

[0050] In order to make it easier to see the position and state of the winding member 12, a developing layer is coated on the outside of the winding member 12, and the developing layer is preferably a tantalum layer.

[0051] The balloon body 11 includes an outer balloon 112 and an inner balloon 111 disposed inside and integrally connected to the outer balloon 112. The winding member 12 is disposed between the inner and outer balloons 111, and fits tightly against both. The double-layer balloon 1 prevents the winding member 12 from moving or falling off during use, thereby facilitating better winding of the balloon body 11.

[0052] The catheter assembly includes an inner tube 2 and an outer tube 3. The inner tube 2 is inserted into the balloon body 11, with its distal end connected to the distal end of the balloon body 11. The outer tube 3 is sheathed over the inner tube 2, with its distal end inserted into the balloon body 11 and connected to the proximal end of the balloon body 11. A flow chamber is formed between the inner and outer tubes 2 and 3 for the flow of an inflation medium, which is in communication with the balloon body 11. Preferably, the inflation medium is a developer solution.

[0053] The operating handle 4 has a filling cavity communicated with the circulation chamber and a guidewire cavity communicated with the inner tube 2 and used for passing the guidewire 5. The specific structure can refer to the existing technology.

[0054] Working principle:

[0055] The temperature of the balloon 1 is controlled to be lower than the set temperature (30±3°C), the balloon 1 is introduced into the target position of the human body, and a low-temperature (5±5°C) expansion medium is introduced into the balloon body 11 to make the balloon body 11 expand outward to an expanded state. The winding member 12 is switched from the initial state to the open state under the drive of the expansion body.

[0056] Under the influence of human body temperature, the winding member 12 gradually heats up to a set temperature or higher than the set temperature, and the winding member 12 has a tendency to transform toward the initial state. Due to the restriction of the balloon body 11, the winding member 12 remains in an open state.

[0057] When the balloon 1 needs to be withdrawn, the expansion medium is released. Without the support of the expansion medium, the balloon body 11 contracts, and the winding member 12 switches to the initial state under its own deformation, and drives the balloon body 11 to rotate around the axis of the balloon body 11 to form a plurality of winding petals, such as Figure 4 shown.

[0058] The above embodiments are intended only to illustrate the technical concepts and features of the present invention. Their purpose is to enable those skilled in the art to understand the contents of the present invention and implement them accordingly. They are not intended to limit the scope of protection of the present invention. Any equivalent changes or modifications made in accordance with the spirit of the present invention are intended to be covered by the scope of protection of the present invention.

Claims

1. A balloon for a catheter, characterized in that: The balloon (1) comprises an expandable or contractible balloon body (11), a plurality of windings (12) connected to the balloon body (11) and distributed around the axis of the balloon body (11), the windings (12) having a shape memory function and being able to be induced to switch between an initial state and a deformed state, the induction comprising thermal induction, and when the temperature of the windings (12) is greater than or equal to a set temperature, the windings (12) have a tendency to switch to the initial state; When the temperature of the winding member (12) is lower than the set temperature, the winding member (12) has a tendency to transform into a deformed state. When the balloon body (11) expands, the winding member (12) has a tendency to expand outwards under the drive of the balloon body (11) and / or the induction; When the balloon body (11) contracts, the winding member (12) can recover from the outwardly expanded deformation state to the initial state under the induction, and drive the balloon body (11) to rotate around the axis of the balloon body (11) to form a plurality of wound petals; The winding member (12) includes a winding portion and two connecting portions (123) respectively arranged at both ends of the winding portion, wherein the connecting portion (123) is spiral-shaped. When the balloon body (11) contracts, the winding portion supports the balloon body (11) to form the valve body. The winding portion includes a main body segment (121) connected to the balloon body (11) and extending axially along the balloon body (11), and two deformable segments (122) symmetrically arranged at both ends of the main body segment (121) and bent. When the winding member (12) switches from a deformed state to an initial state, the deformable segment (122) drives the main body segment (121) to wind inward.

2. The catheter balloon according to claim 1, wherein The winding member (12) is formed by bending a metal wire; and / or, The material of the winding member (12) is nickel-titanium alloy.

3. The catheter balloon according to claim 1, wherein: The outer side of the winding member (12) is coated with a developing layer.

4. The catheter balloon according to claim 1, wherein The balloon body (11) comprises an outer balloon (112) and an inner balloon (111) connected to the inner side of the outer balloon (112); the winding member (12) is arranged between the inner balloon (111) and the outer balloon (112) and is tightly fitted to both.

5. The catheter balloon according to claim 1, wherein: The set temperature is not greater than human body temperature.

6. A balloon dilatation catheter, characterized in that: The invention comprises the catheter balloon according to any one of claims 1 to 5.

7. The balloon dilatation catheter according to claim 6, characterized in that: The balloon dilatation catheter further comprises an operating handle (4) and an inner tube (2) and an outer tube (3) connected to the operating handle (4); the inner tube (2) is inserted into the balloon body (11) and the distal end is connected to the distal end of the balloon body (11); the outer tube (3) is sleeved on the outside of the inner tube (2) and the distal end is inserted into the balloon body (11) and connected to the proximal end of the balloon body (11); a flow chamber for the circulation of an expansion medium and connected to the balloon body (11) is formed between the inner tube (2) and the outer tube (3); the operating handle (4) has a filling chamber connected to the flow chamber and a guidewire chamber connected to the inner tube (2) and used for inserting a guidewire (5).

8. A method for folding a catheter balloon according to any one of claims 1 to 5, characterized in that: The method includes releasing the expansion medium in the balloon body (11), heating the balloon (1), and inducing the winding member (12) to switch to an initial state to drive the winding member (12) to rotate around its axis with the balloon body (11) to form a plurality of wound petals.

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