Fallopian tube contrast catheter with t-shaped balloon

Abstract

The utility model provides a kind of falloscopy catheter with T type balloon, it is related to medical instrument field, and it includes: flexible catheter main body, its distal end forms catheter head end;T type balloon assembly is integrally formed by proximal end bulge and distal end extension, the outer diameter of the proximal end bulge is greater than the outer diameter of catheter head end and is configured as the radial expansion form of shape adaptation with uterine cavity, and the distal end extension extends along flexible catheter main body axially and is fixedly connected with the distal end of catheter head end.The outer diameter of the proximal end bulge of T type balloon assembly is greater than catheter head end in the application, adapt uterine cavity shape, match with uterine horn profile when filling, uniform adhere to uterine wall, prevent catheter skew, guarantee contrast medium injection accurate.

Description

Technical Field

[0001] This utility model relates to the field of medical devices, and in particular to a fallopian tube angiography catheter with a T-shaped balloon. Background Technology

[0002] In hysterosalpingography (HSG), the precise and stable placement of the catheter into the uterus and fallopian tubes is crucial for obtaining clear images and achieving accurate diagnosis. However, traditional HSG catheters have significant drawbacks, among which the balloon shape leading to catheter tip misalignment severely affects the examination results. Traditional contrast catheters are typically equipped with ordinary round or oval balloons. Due to the irregular shape of the uterine cavity and the varying physiological structures of the uterus in different patients, the balloon, when inflated, is difficult to conform evenly to the uterine wall. Uneven pressure causes the catheter tip to easily deviate. Once deviated, it cannot be accurately aligned with the fallopian tube opening, resulting in a deviation in the direction of contrast agent injection and hindering its smooth flow into the fallopian tubes. This, in turn, affects the accurate assessment of fallopian tube patency and morphology. Furthermore, catheter tip deviation increases procedural risks. When adjusting a catheter that has deviated from its normal path, the doctor may unintentionally increase the pushing force, causing excessive pressure on the uterine wall, leading to patient pain, and in severe cases, even uterine perforation. This is especially true for patients with excessive anteversion, retroversion, or malformations (such as a saddle-shaped uterus or a septate uterus), where ordinary balloons are difficult to adapt to the complex uterine cavity, making catheter tip deviation even more pronounced and significantly increasing the difficulty and risk of failure in the hysterosalpingography (HSG) procedure. Therefore, a T-shaped balloon-based HSG catheter has been proposed. Utility Model Content

[0003] This invention addresses the shortcomings of existing technologies by using a T-shaped balloon assembly with a proximal expansion section having an outer diameter larger than the catheter tip. This allows it to adapt to the shape of the uterine cavity, match the contour of the uterine horn when inflated, uniformly conform to the uterine wall, prevent catheter deviation, and ensure accurate injection of contrast agent.

[0004] To solve the above-mentioned technical problems, this utility model solves the problem of the traditional catheter tip being prone to tilting through the following technical solution.

[0005] To achieve the above objectives, the present invention adopts the following technical solution: A hysterosalpingography catheter with a T-balloon includes: The flexible catheter body has a distal end that forms the catheter tip. The T-shaped balloon assembly is integrally formed from a proximal expansion portion and a distal extension portion. The outer diameter of the proximal expansion portion is larger than the outer diameter of the catheter tip and is configured in a radially expanded shape that adapts to the shape of the uterine cavity. The distal extension portion extends axially along the flexible catheter body and is fixedly connected to the distal end of the catheter tip. The proximal expansion portion of the T-balloon assembly is configured to form a support surface that matches the contour of the uterine horn when inflated.

[0006] Preferably, the distal extension has a gradually changing outer diameter structure, with its proximal outer diameter equal to the distal outer diameter of the proximal enlargement and its distal outer diameter equal to the outer diameter of the catheter tip, forming a continuously transitioning conical surface.

[0007] Preferably, the thickness of the proximal enlargement is greater than that of the distal extension.

[0008] Preferably, the outer surface of the T-shaped balloon assembly is provided with a biocompatible coating.

[0009] Preferably, the biocompatible coating has a microporous structure, and antibacterial particles are dispersed within the micropores.

[0010] Compared with the prior art, the present invention has the following beneficial effects: The fallopian tube contrast catheter with T-balloon provided in this application has an outer diameter of the proximal dilatation portion of the T-balloon assembly that is larger than the catheter tip, adapting to the shape of the uterine cavity. When filled, it matches the contour of the uterine horn, uniformly conforms to the uterine wall, prevents catheter deviation, and ensures accurate injection of contrast agent.

[0011] The T-shaped balloon assembly of this application features a proximal expansion portion with a thickness greater than the distal extension portion, which effectively maintains balloon stability. The outer surface of the T-shaped balloon assembly is provided with a biocompatible coating with a microporous structure, in which antibacterial particles are dispersed, which can effectively inhibit bacterial growth, reduce the risk of intrauterine infection, and improve the safety of the examination.

[0012] The distal extension of this application has a gradually changing outer diameter structure. From the proximal end to the distal end, the outer diameter transitions from being equal to the distal outer diameter of the proximal dilatation to being equal to the outer diameter of the catheter tip, forming a continuously transitioning conical surface. This reduces stimulation to the uterine cavity tissue and improves the patient's comfort during the examination. Attached Figure Description

[0013] To more clearly illustrate the technical solutions in the embodiments of this utility model, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0014] Figure 1 This is a schematic diagram of the overall structure of this utility model; Figure 2 This is a schematic diagram of the disassembled structure of this utility model; Figure 3 This is a partial cross-sectional structural diagram of the T-shaped balloon assembly of this utility model; Figure 4 This is a schematic diagram of the shape memory alloy support structure of this utility model.

[0015] Figure number explanation: 1. Flexible catheter body; 11. Catheter tip; 2. T-shaped balloon assembly; 21. Proximal expansion; 22. Distal extension; 31. Shape memory alloy support; 4. Biocompatible coating; 41. Microporous structure; 42. Antibacterial particles. Detailed Implementation

[0016] The present invention will now be described in further detail with reference to the accompanying drawings.

[0017] The following description is intended to disclose the present invention so that those skilled in the art can implement it. The preferred embodiments described below are merely examples, and other obvious modifications will be apparent to those skilled in the art. The basic principles of the present invention defined in the following description can be used in other embodiments, modifications, improvements, equivalents, and other technical solutions that do not depart from the spirit and scope of the present invention.

[0018] Those skilled in the art should understand that in the disclosure of this utility model, the terms "longitudinal", "lateral", "up", "down", "left", "right", "front", "rear", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or position based on the orientation or positional relationship shown in the accompanying drawings. They are only for the purpose of simplifying the description of this utility model and do not indicate or imply that the device or component referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, the above terms should not be construed as limitations on this utility model.

[0019] It is understood that the term "a" should be understood as "at least one" or "one or more", that is, in one embodiment, the number of an element can be one, while in another embodiment, the number of the element can be multiple, and the term "a" should not be understood as a limitation on the number. Example

[0020] Please see Figure 1-3 A T-balloon-assisted hysterosalpingography catheter includes: a flexible catheter body 1, the distal end of which forms a catheter tip 11; The T-shaped balloon assembly 2 is integrally formed from a proximal expansion portion 21 (i.e., the balloon body) and a distal extension portion 22. The outer diameter of the proximal expansion portion 21 is larger than the outer diameter of the catheter tip 11 and is configured in a radially extended form that is adapted to the shape of the uterine cavity. The distal extension portion 22 extends axially along the flexible catheter body 1 and is fixedly connected to the distal end of the catheter tip 11. In some embodiments, the T-shaped balloon assembly 2 consists of a proximal enlargement 21 (i.e., the balloon body) and a silicone thickening structure at its tail.

[0021] In some embodiments, to improve the support effect of the balloon, a support body can be integrally provided inside the proximal expansion portion 21; the support body is a shape memory alloy support body 31, and the support body is also convenient for patients with cervical adhesions to use. The support increases the rigidity and avoids the problem of the soft tube structure being blocked by the adhesions and difficult to insert.

[0022] In addition, a metal layer can be provided on the surface of the proximal enlargement 21 to increase the support effect.

[0023] In this application, the balloon body of the T-shaped balloon assembly 2 is thickened at the connection with the flexible catheter body 1 to increase stability.

[0024] The proximal expansion portion 21 of the T-balloon assembly 2 is configured to form a support surface that matches the contour of the uterine horn when inflated.

[0025] The T-type balloon fallopian tube angiography catheter of this application is mainly composed of a flexible catheter body 1, a catheter tip 11, a T-type balloon assembly 2, a proximal expansion section 21, and a distal extension section 22. The following is a detailed description of its structure and working principle.

[0026] Detailed structure and connection method of each component Catheter assembly fabrication: The flexible catheter body 1 is made of medical-grade flexible materials, such as medical silicone or polyurethane, and manufactured through extrusion molding to ensure its flexibility and strength meet the requirements for intrauterine operation. The catheter tip 11 is finely machined to have a suitable shape and size for easy connection with the T-balloon assembly 2. The T-balloon assembly 2 uses a double-layer polymer material membrane, integrally formed by hot pressing of the proximal expansion portion 21 and the distal extension portion 22. The size and shape of the proximal expansion portion 21 are designed and optimized based on a large amount of clinical uterine cavity morphology data to achieve a good fit with the uterine cavity. The outer diameter of the distal extension portion 22 is controlled during the molding process to form a gradual outer diameter structure, meeting the requirement of a smooth transition with the catheter tip 11.

[0027] The T-shaped balloon assembly features a proximal expansion section with a thickness greater than the distal extension section. This thicker proximal expansion section provides better support, reducing the likelihood of the balloon deforming or twisting under pressure. This makes the balloon more stable in the blood vessel, helping to accurately position it at the lesion site and maintain a stable shape during expansion.

[0028] After the T-shaped balloon assembly 2 is formed, a biocompatible coating 4 is prepared on its outer surface using a spraying or dip-coating process. The biocompatible coating 4 is made of a medical polymer with good biocompatibility, such as polylactic acid-glycolic acid copolymer (PLGA). During the coating preparation process, a microporous structure 41 is formed through a special pore-forming process, and antibacterial particles 42, such as silver ions, copper ions, and other antibacterial metal particles, are uniformly dispersed within the micropores, thus completing the antibacterial functionalization treatment of the balloon.

[0029] The distal extension 22 of the prepared T-balloon assembly 2 is fixedly connected to the catheter tip 11 using medical-grade adhesive or hot-melt welding to ensure that the connection is well sealed and secure, thus completing the overall assembly of the fallopian tube angiography catheter with T-balloon.

[0030] II. Working Principle After the T-balloon-equipped hysterosalpingography catheter is inserted into the uterine cavity, a medium of liquid or gas is injected into the T-balloon assembly 2 to inflate it. The proximal dilatation 21, relying on its special shape that matches the contour of the uterine horn, can uniformly conform to the uterine wall during radial expansion. Traditional balloons, due to their limited shape, are difficult to adapt to irregular uterine cavities, resulting in uneven pressure distribution. The unique conformation method of the T-balloon effectively avoids this problem of uneven pressure and prevents the catheter tip 11 from deviating.

[0031] After the T-balloon is stably positioned, contrast agent is injected through the flexible catheter body 1. Due to the precise positioning of the catheter tip 11, the contrast agent flows smoothly into the flexible catheter body 1 in the expected direction, thus clearly demonstrating the patency and shape of the flexible catheter body 1 under imaging equipment. This process avoids deviations in the injection direction of the contrast agent due to misalignment of the catheter tip 11, enabling physicians to obtain more accurate imaging information and improving diagnostic precision.

[0032] Throughout the examination, the biocompatible coating 4 on the outer surface of the T-balloon assembly 2 plays a crucial role. The antibacterial particles 42 dispersed within its microporous structure 41 continuously release antibacterial substances, inhibiting bacterial adhesion and reproduction on the balloon surface and surrounding uterine tissue, reducing the risk of intrauterine infection, and ensuring the patient's health and safety.

[0033] Those skilled in the art should understand that the embodiments of the present invention described above and shown in the accompanying drawings are merely examples and do not limit the present invention. The purpose of the present invention has been fully and effectively achieved. The functions and structural principles of the present invention have been shown and explained in the embodiments. Without departing from the stated principles, the implementation of the present invention may have any variations or modifications.

Claims

1. A T-shaped balloon hysterosalpingography catheter, characterized in that, include: The flexible catheter body (1) has a distal end forming the catheter tip (11). The T-shaped balloon assembly (2) is integrally formed from a proximal expansion portion (21) and a distal extension portion (22). The outer diameter of the proximal expansion portion (21) is larger than the outer diameter of the catheter tip (11) and is configured in a radially extended shape that is adapted to the shape of the uterine cavity. The distal extension portion (22) extends axially along the flexible catheter body (1) and is fixedly connected to the distal end of the catheter tip (11). The proximal expansion (21) of the T-balloon assembly (2) is configured to form a support surface that matches the contour of the uterine horn when inflated; The distal extension (22) has a gradually changing outer diameter structure, the proximal outer diameter of which is equal to the distal outer diameter of the proximal enlargement (21), and the distal outer diameter of which is equal to the outer diameter of the catheter tip (11), forming a continuously transitioning conical surface. The thickness of the proximal enlargement (21) is greater than that of the distal extension (22).

2. The T-shaped balloon hysterosalpingography catheter according to claim 1, wherein: The outer surface of the T-shaped balloon assembly (2) is provided with a biocompatible coating (4).

3. The fallopian tube angiography catheter with a T-shaped balloon according to claim 2, characterized in that: The biocompatible coating (4) has a microporous structure (41) in which antibacterial particles (42) are dispersed.

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