A four-lumen double-balloon universal urethral drug delivery catheter

Abstract

This invention discloses a four-lumen, double-balloon universal urethral medication catheter, comprising a tube body with four independent lumens: a urination cavity for draining urine, distally connected to a drainage port; a urethral medication cavity for instilling medication or flushing fluid, distally connected to a urethral medication port; a first balloon inflation cavity for controlling the inflation of the first balloon; and a second balloon inflation cavity for controlling the inflation of the second balloon. The first balloon is located distally in the catheter for fixation in the bladder trigone; the second balloon is located proximally in the catheter for sealing the urethra. The urethral medication port is located on the side wall of the tube body between the first and second balloons. The first balloon inflation cavity has a one-way valve at its external end, allowing independent control of the inflation pressure of the first balloon. This invention, through its four-lumen, double-balloon design, solves problems such as urethral medication reflux, limited functionality, and the risk of cross-contamination, making it particularly suitable for local treatment of urethral fibrosis.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically a multifunctional catheter that enables closed-loop drug delivery and catheterization of the urethra, suitable for treatment scenarios requiring local drug administration, such as urethral stricture and inflammation. Background Technology

[0002] Existing urinary catheters (such as Foley catheters) have the following defects:

[0003] Drug reflux: The single balloon design cannot close the urethra, and the drug is prone to reflux into the bladder or outside the body during injection;

[0004] Limited functionality: It only supports urinary catheterization or simple flushing and cannot simultaneously achieve targeted drug delivery to the urethra;

[0005] Risk of cross-contamination: The lack of isolation design between multiple cavities makes it easy for medication and urine to mix;

[0006] Risk of clinical error: Multi-lumen catheter interfaces are easily confused, which may lead to incorrect drug administration, incorrect flushing, or over-inflation of the balloon. Utility Model Content

[0007] To address the shortcomings of the existing technology, this invention provides a universal four-lumen double-balloon urethral injection catheter that can simultaneously perform urethral closed injection and catheterization, while avoiding cross-contamination, reducing the risk of clinical errors, and improving efficiency.

[0008] To achieve the above objectives, the present invention adopts the following technical solution:

[0009] A four-lumen double-balloon universal urethral drug delivery catheter includes a tubing body, wherein the tubing body has four independent lumens, namely:

[0010] The urination cavity is used to drain urine, and its distal end is connected to the drainage hole.

[0011] The urethral injection cavity is used for instilling drugs or flushing fluid, and its distal end connects to the urethral injection port.

[0012] The first balloon inflation cavity is used to control the inflation of the first balloon;

[0013] The second balloon inflation chamber is used to control the inflation of the second balloon.

[0014] The first balloon is located at the distal end of the catheter and is used to fix it to the trigone of the bladder;

[0015] The second balloon is located at the proximal end of the catheter and is used to close the urethra;

[0016] The urethral injection port is located on the side wall of the tube between the first balloon and the second balloon;

[0017] The first balloon inflation chamber is equipped with a one-way valve at its external end, which can independently control the inflation pressure of the first balloon;

[0018] The second balloon inflation chamber is equipped with a one-way valve at its external end, which can independently control the inflation pressure of the second balloon.

[0019] Furthermore, the first balloon adheres tightly to the tube wall before inflation and often takes the shape of an apple / pear after inflation. The inflation pressure is typically 25-35 cmH2O, and it is made of natural latex, medical-grade silicone, or polyurethane. The second balloon adheres tightly to the tube wall and slightly protrudes from the tube wall after inflation. The inflation pressure is typically 25-35 cmH2O, and it is made of natural latex, medical-grade silicone, or polyurethane.

[0020] Furthermore, the diameter of the urethral injection port is 0.5-2.0 mm.

[0021] Furthermore, the urination cavity and the urethral injection cavity are independent cavities to prevent cross-contamination of fluids between the cavities.

[0022] Furthermore, the surface of the second balloon is provided with imaging markers for X-ray positioning.

[0023] Furthermore, the external interfaces of the tube body, such as the urination cavity, the urethral injection cavity, the first balloon inflation cavity, and the second balloon inflation cavity, are all distinguished by printed text markings and color-coded sleeves.

[0024] Furthermore, the four-lumen double-balloon universal urethral drug delivery catheter also possesses at least one of the following technical features:

[0025] The length of the tube is 150-500 mm;

[0026] The distance between the first balloon and the second balloon is 30-100 mm;

[0027] The first balloon has a capacity of 20-30 ml and a length of 10-30 mm;

[0028] The second balloon has a capacity of 2-5 ml and a length of 5-15 mm;

[0029] The inner diameter of the urethral injection cavity is 0.6-1.5 mm.

[0030] Furthermore, the printed text markings and color swatches specifically include:

[0031] The urination cavity interface is covered with a black color-coded sleeve and printed with the word "urination";

[0032] The urethral injection port is fitted with a blue color-coded sleeve and printed with the words "Injection".

[0033] The first balloon inflation chamber interface is covered with a red color-coded sleeve and printed with "Balloon 1";

[0034] The second balloon inflation chamber interface is covered with a yellow color-coded sleeve and printed with "Balloon 2";

[0035] The color mark sleeve is made of medical-grade silicone and is heat-sealed to the tube body.

[0036] Furthermore, the printed text is produced using laser etching technology, with a font height of ≥2.5 mm, ensuring legibility under low light conditions.

[0037] Compared with the prior art, the advantages of this utility model are:

[0038] 1. Precise drug delivery: Double balloon occlusion ensures that the drug remains at the site of the urethral lesion, preventing the drug from flowing back into the bladder or outside the body;

[0039] 2. Multifunctional Simultaneous: Catheterization and medication administration do not interfere with each other, avoiding the risk of cross-contamination;

[0040] 3. Safe and controllable: The balloon pressure controllable design avoids over-inflation of the balloon, which can cause mucosal damage.

[0041] 4. Improve efficiency: The application of printed text labels and color-coded sleeves can avoid confusion between multi-lumen catheter interfaces, which may lead to accidental drug administration or flushing. Attached Figure Description

[0042] Figure 1 This is a structural diagram of the catheter of this utility model;

[0043] Figure 2 This is a cross-sectional view (AA) of the tube body of this utility model.

[0044] In the diagram: 1. Tube body; 11. Urinary cavity; 111. Drainage hole; 12. Urethral injection cavity; 121. Urethral injection hole; 13. First balloon inflation cavity; 131. First balloon; 14. Second balloon inflation cavity; 141. Second balloon. Detailed Implementation

[0045] The present invention will now be described in further detail with reference to the accompanying drawings and specific embodiments.

[0046] like Figure 1 and 2As shown, a four-lumen double-balloon universal urethral drug injection catheter includes a tube body 1, which has four independent lumens: a urination cavity 11 for draining urine, with its distal end connected to a drainage hole 111; a urethral drug injection cavity 12 for infusing drugs or flushing fluid, with its distal end connected to a urethral drug injection hole 121; the catheterization and drug injection do not interfere with each other, avoiding the risk of cross-contamination. The first balloon inflation chamber 13 is used to control the inflation of the first balloon 131; the second balloon inflation chamber 14 is used to control the inflation of the second balloon 141. The first balloon 131 is located at the distal end of the catheter and is used to fix it in the trigone of the bladder; the second balloon 141 is located at the proximal end of the catheter and is used to close the urethra; the urethral injection port 121 is located on the side wall of the tube between the first balloon 131 and the second balloon 141. The medication is injected into the closed space formed by the urethra and the catheter through the urethral injection port 121, and it is filled into the entire closed space by controllable pressure flow to ensure that the medication covers the lesion site; the first balloon inflation chamber 13 is provided with a one-way valve at its external end, which can independently control the inflation pressure of the first balloon 131; the second balloon inflation chamber 14 is provided with a one-way valve at its external end, which can independently control the inflation pressure of the second balloon 141. The first balloon 131 adheres tightly to the tube wall before inflation and typically takes on an apple / pear shape after inflation. The inflation pressure is usually 25-35 cmH2O. The catheter is made of medical-grade silicone or polyurethane. The second balloon 141 adheres tightly to the tube wall and slightly protrudes after inflation. The inflation pressure is also usually 25-35 cmH2O. It is also made of medical-grade silicone or polyurethane. Gas (sterile water) can be injected or withdrawn from the balloons via one-way valves at the outer ends of the inflation chambers of the first and second balloons to control inflation or deflation. The balloon pressure is safely and controllably controlled via the one-way valves to prevent over-inflation and mucosal damage. The diameter of the urethral injection port 121 is 0.5-2.0 mm. The urination chamber 11 and the urethral injection chamber 12 are independent cavities to prevent cross-contamination of fluids between cavities. The surface of the second balloon 141 is marked with radiopaque markers made of barium wire or platinum rings for X-ray positioning. The external interfaces of the tube body 1, such as the urination cavity 11, the urethral injection cavity 12, the first balloon inflation cavity 13, and the second balloon inflation cavity (14), are all distinguished by printed text markings and color-coded sleeves. The four-lumen double-balloon universal urethral injection catheter also has at least one of the following technical features: the length of the tube body 1 is 150-500mm; the distance between the first balloon 131 and the second balloon 141 is 30-100mm; the capacity of the first balloon 131 is 20-30ml and the length is 10-30mm; the capacity of the second balloon 141 is 2-5ml and the length is 5-15mm; the inner diameter of the urethral injection cavity 12 is 0.6-1.5mm.The printed text markings and color-coded sleeves specifically include: Urinary cavity interface 11: black color-coded sleeve, printed with "URINE" (urination); urethral medication injection interface 12: blue color-coded sleeve, printed with "DRUG" (medication injection); first balloon inflation cavity interface 13: red color-coded sleeve, printed with "BALLOON 1" (balloon 1); second balloon inflation cavity interface 14: yellow color-coded sleeve, printed with "BALLOON 2" (balloon 2). The color-coded sleeves are made of medical-grade silicone and are heat-sealed to the tube body 1. The printed text is laser-etched with a font height ≥2.5 mm to ensure legibility under low light conditions. The medical connector color coding standard complies with the standardization requirements of ISO 80369-7. By using printed text markings and color-coded sleeves on the external interfaces of the tube body 1 to differentiate interfaces, confusion between multi-lumen catheter interfaces can be avoided, potentially leading to accidental medication injection or flushing. This allows for rapid interface identification, thus shortening rescue or treatment time (such as emergency catheterization).

[0047] Instructions for use: Insert the catheter into the bladder through the urethra → Inflate the first balloon 131 and gently pull the catheter to fix the first balloon 131 in the trigone of the bladder → Inflate the second balloon 141 to close the urethral opening → Inflate the urethra with medication (such as rapamycin) or flushing solution through the urethral injection cavity 12.

[0048] It should be noted that the above description is only a description of the preferred embodiment of this utility model and is not intended to limit the scope of this utility model in any way. Any changes or modifications made by those skilled in the art based on the above disclosure shall fall within the protection scope of this utility model. Obviously, those skilled in the art can make various modifications and variations to the utility model without departing from the spirit and scope of this utility model. Therefore, if these modifications and variations fall within the scope of this utility model and its equivalents, this utility model also intends to include these modifications and variations.

Claims

1. A universal four-lumen double-balloon urethral drug infusion catheter, comprising a catheter body (1), characterized in that, The tube (1) has four independent cavities, namely: The urination cavity (11) is used to drain urine and is connected to the drainage hole (111) at the distal end. The urethral injection cavity (12) is used for instilling drugs or flushing fluid, and its distal end is connected to the urethral injection port (121). The first balloon inflation cavity (13) is used to control the inflation of the first balloon (131); The second balloon inflation cavity (14) is used to control the inflation of the second balloon (141). The first balloon (131) is located at the distal end of the catheter and is used to fix it to the trigone of the bladder; The second balloon (141) is located at the proximal end of the catheter and is used to close the urethra; The urethral injection port (121) is located on the side wall of the tube between the first balloon (131) and the second balloon (141); The first balloon inflation chamber (13) is provided with a one-way valve at its external end, which can independently control the inflation pressure of the first balloon (131); The second balloon inflation chamber (14) is equipped with a one-way valve at its external end, which can independently control the inflation pressure of the second balloon (141).

2. The universal four-lumen double-balloon urethral drug infusion catheter according to claim 1, characterized in that, The first balloon (131) is attached to the tube wall before inflation and usually has an apple / pear-shaped structure after inflation. The inflation pressure is 25-35 cmH2O. It is made of natural latex, medical-grade silicone or polyurethane. The second balloon (141) is attached to the tube wall and protrudes slightly from the tube wall after inflation. The inflation pressure is 25-35 cmH2O. It is made of natural latex, medical-grade silicone or polyurethane.

3. The universal four-lumen double-balloon urethral drug infusion catheter according to claim 1, characterized in that, The diameter of the urethral injection port (121) is 0.5-2.0 mm.

4. The universal four-lumen double-balloon urethral drug infusion catheter according to claim 1, characterized in that, The urination cavity (11) and the urethral injection cavity (12) are independent cavities to prevent fluid cross-contamination and pollution between the cavities.

5. The universal four-lumen double-balloon urethral drug infusion catheter according to claim 1, characterized in that, The surface of the second balloon (141) is provided with imaging marks for X-ray positioning.

6. The universal four-lumen double-balloon urethral drug infusion catheter according to claim 1, characterized in that, The external interfaces of the tube body (1), such as the urination cavity (11), the urethral injection cavity (12), the first balloon inflation cavity (13), and the second balloon inflation cavity (14), are all distinguished by printed text markings and color-coded sleeves.

7. The universal four-lumen double-balloon urethral drug infusion catheter according to claim 1, characterized in that, The four-lumen double-balloon universal urethral drug delivery catheter also has at least one of the following technical features: The length of the tube (1) is 150-500 mm; The distance between the first balloon (131) and the second balloon (141) is 30-100 mm; The first balloon (131) has a capacity of 20-30 ml and a length of 10-30 mm; The second balloon (141) has a capacity of 2-5 ml and a length of 5-15 mm; The inner diameter of the urethral injection cavity (12) is 0.6-1.5 mm.

8. The universal four-lumen double-balloon urethral drug infusion catheter according to claim 6, characterized in that, The printed text markings and color swatches specifically include: The external end interface of the urination cavity (11) is covered with a black color-coded sleeve and printed with the words "urination"; The external end interface of the urethral injection cavity (12) is covered with a blue color-coded sleeve and printed with the words "Injection". The external end interface of the first balloon inflation cavity (13) is covered with a red color label and printed with "Balloon 1"; The external end interface of the second balloon inflation chamber (14) is covered with a yellow color label and printed with "Balloon 2"; The color mark sleeve is made of medical-grade silicone and is heat-sealed to the tube body (1).

9. The universal four-lumen double-balloon urethral drug infusion catheter according to claim 8, characterized in that, The printed text is produced using laser etching technology, with a font height of ≥2.5 mm, ensuring legibility under low light conditions.

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