Prostatic balloon dilation catheter

Abstract

The utility model relates to a kind of prostatic balloon dilatation catheter, it includes tube body, limiting balloon, dilatation balloon, connecting rope and fixed anchor, tube body distal end is equipped with drainage port, proximal end is connected fixed anchor by connecting rope, limiting balloon and dilatation balloon are sleeved on tube body, developing ring is equipped on the pipe section between limiting balloon and dilatation balloon of tube body, urine drainage passage and balloon cavity are axially equipped in tube body, urine drainage passage one end is communicated with the drainage port of tube body distal end, other end is communicated with the proximal end tube mouth of tube body, balloon cavity is axially spaced and fixed and is equipped with distal valve and proximal valve.The utility model has the advantages that, the dilatation catheter can be placed in human body basically completely, external bacteria is not easy to invade, thereby reducing urethral infection;While treating prostatic hyperplasia, it does not affect patient autonomous urination, without urine collection bag, improve patient's quality of life, and long-term placement will not affect patient's autonomous urination function;Simple structure, easy to operator.

Description

Technical Field

[0001] This utility model belongs to the field of medical device technology, specifically relating to a prostate balloon dilation catheter. Background Technology

[0002] The prostate gland, located directly below the bladder and surrounding the urethra, enlarges continuously from puberty under the influence of testosterone until old age. Prostatic hyperplasia (BPH) can compress urethral space, easily causing urethral stricture and affecting normal urination. BPH leads to posterior urethral elongation, compression deformation, stricture, and increased urethral resistance, causing high bladder pressure and related voiding symptoms. With increased bladder pressure, compensatory hypertrophy of the detrusor muscle occurs, leading to detrusor instability and related storage symptoms. If the obstruction is not relieved for a long period, the detrusor muscle loses its compensatory capacity. Upper urinary tract changes secondary to BPH, such as hydronephrosis and renal impairment, are mainly caused by increased intrabladder pressure. Currently, advanced treatment technologies are mostly imported, such as Boston Scientific's Rezūm and Teriform's UroLift.

[0003] Currently, surgical treatments for benign prostatic hyperplasia (BPH) include transurethral resection of the prostate (TURP), transurethral holmium laser enucleation of the prostate, open prostatectomy, Boston Scientific's Rezūm thermal steam ablation technology, and Terifor's UroLift prostate repositioning technique. Prostate surgery carries the following risks: intraoperative complications such as unexpected bleeding and nerve damage may occur; postoperative complications such as difficulty urinating, urinary incontinence, and urethral stricture may arise, and some patients may require further surgery to resolve these issues. For these reasons, it is necessary to provide a safer medical device for treating BPH. Utility Model Content

[0004] This invention provides a prostate balloon dilation catheter, which aims to overcome the above-mentioned shortcomings of the prior art.

[0005] The technical solution of this utility model to solve the above-mentioned technical problems is as follows: A prostate balloon dilation catheter includes a tube body, a limiting balloon, a dilation balloon, a connecting rope, and a fixing anchor. The distal end of the tube body is provided with a drainage port, and the proximal end is connected to the fixing anchor via the connecting rope. The limiting balloon and the dilation balloon are sleeved on the tube body. The limiting balloon is close to the distal end of the tube body, and the dilation balloon is close to the proximal end of the tube body. A contrast-enhancing ring is provided on the section of the tube body between the limiting balloon and the dilation balloon. A axially arranged... It has a urine drainage channel and a balloon cavity. One end of the urine drainage channel is connected to the drainage port at the distal end of the tube body, and the other end is connected to the proximal end of the tube body. The balloon cavity is fixedly provided with a distal valve and a proximal valve at intervals along the axial direction. The balloon cavity is connected to the limiting balloon through a cavity segment one located on the side of the distal valve near the drainage port, and the balloon cavity is connected to the dilating balloon through a cavity segment two located between the distal valve and the proximal valve. Both the distal valve and the proximal valve are self-closing rubber plugs.

[0006] Based on the above technical solution, the present invention can be further improved as follows.

[0007] Furthermore, the distal end of the tube has an arc-shaped closed end, and the drainage port is located on the side wall of the tube.

[0008] Furthermore, the dilation balloon is elongated, with one end close to the imaging ring and the other end close to the proximal end face of the tube body.

[0009] Furthermore, one end of the connecting rope is fixedly connected to the proximal end face of the tube body, and the other end is fixedly connected to the fixed anchor.

[0010] Furthermore, the fixing anchor is a bent and coiled metal wire or a flexible plastic sheet that is bent into an arc shape after being compressed.

[0011] Furthermore, the fixing anchor is a flexible plastic sheet and is wedge-shaped with a larger distal end and a smaller proximal end. The distal end of the fixing anchor is fixedly connected to the connecting rope, and the proximal end is connected to the other end of the traction rope by passing through the center of the distal valve and the proximal valve in sequence and then being proximally connected to the balloon cavity.

[0012] Furthermore, a fixing block is provided inside the cavity, and the fixing block is fixedly connected to one end of the guide rope, while the other end of the guide rope extends from the proximal end of the balloon cavity.

[0013] Furthermore, the limiting balloon and the dilating balloon are made of silicone or TPU, and the tube body is made of silicone or polyurethane.

[0014] Compared with the prior art, the beneficial effects of this utility model are:

[0015] 1. This prostate balloon dilation catheter can be placed almost entirely inside the human body, making it difficult for external bacteria to invade, thereby reducing urethral infections;

[0016] 2. While treating benign prostatic hyperplasia, it does not affect the patient's independent urination. The tube body is located at the upper end of the external sphincter, which drains the urine in the bladder into the urethra at the upper end of the external sphincter, and then allows the patient to urinate independently. There is no need for a urine collection bag, which improves the patient's quality of life. Moreover, long-term placement will not affect the patient's independent urination function.

[0017] 3. This prostate balloon dilation catheter is made of biocompatible polymer material and can be left in the human body for a long time, prolonging the treatment time of benign prostatic hyperplasia. Its structure is simple and easy for the operator to operate. The device can be removed from the body without the aid of any auxiliary equipment, and the operation time is short. Attached Figure Description

[0018] Figure 1 A schematic diagram of a prostate balloon dilation catheter provided by this utility model;

[0019] Figure 2 for Figure 1 The diagram shows the internal structure of the prostate balloon dilation catheter.

[0020] Figure 3 for Figure 1 The diagram shows the prostate balloon dilation catheter during balloon inflation.

[0021] Figure 4 for Figure 1 The diagram shows a prostate balloon dilation catheter inserted into the patient's body.

[0022] The attached diagram lists the components represented by each number as follows:

[0023] 1. Tube body; 2. Limiting balloon; 3. Inflatable balloon; 4. Connecting rope; 5. Fixing anchor; 6. Drainage port; 7. Contrast ring; 8. Urine drainage channel; 9. Balloon cavity; 10. Distal valve; 11. Proximal valve; 12. Traction rope; 13. Fixing block; 14. Guide rope; 15. Injection guide needle; 16. Y valve;

[0024] 20. Bladder; 30. Bladder neck; 40. Prostate; 50. External sphincter; 60. Urethra. Detailed Implementation

[0025] The principles and features of this utility model are described below with reference to the accompanying drawings. The examples given are only for explaining this utility model and are not intended to limit the scope of this utility model.

[0026] In the description of this utility model, if terms such as "upper", "lower", "left", "right", "top", "bottom", "inner", and "outer" are used to indicate the orientation or positional relationship, the orientation or positional relationship indicated is based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model.

[0027] like Figures 1 to 3 As shown, this utility model provides a prostate balloon dilation catheter, which includes a tube body 1, a limiting balloon 2, a dilation balloon 3, a connecting rope 4, and a fixing anchor 5. The distal end of the tube body 1 has a drainage port 6, and the proximal end is connected to the fixing anchor 5 via the connecting rope 4. The limiting balloon 2 and the dilation balloon 3 are sleeved on the tube body 1, with the limiting balloon 2 near the distal end of the tube body 1 and the dilation balloon 3 near the proximal end of the tube body 1. A contrast-enhancing ring 7 is provided on the section of the tube body 1 between the limiting balloon 2 and the dilation balloon 3. A urine drainage channel 8 is provided axially inside the tube body 1. The balloon cavity 9 has a urine drainage channel 8, one end of which is connected to the drainage port 6 at the distal end of the tube body 1, and the other end of which is connected to the proximal end of the tube body 1. The balloon cavity 9 is axially spaced and fixedly provided with a distal valve 10 and a proximal valve 11. The balloon cavity 9 is connected to the limiting balloon 2 through a cavity segment one located on the side of the distal valve 10 near the drainage port 6. The balloon cavity 9 is connected to the dilating balloon 3 through a cavity segment two located between the distal valve 10 and the proximal valve 11. Both the distal valve 10 and the proximal valve 11 are self-closing rubber plugs.

[0028] It should be noted that the limiting balloon and the dilating balloon are preferably made of polymer materials with a certain degree of elasticity and good biocompatibility, while the tubing is preferably made of a biocompatible polymer material with a certain degree of hardness that can withstand moderate pressure without deformation. The surface of the dilating balloon can also be coated with therapeutic drugs such as paclitaxel, allowing for sufficient absorption of the drug at the target site during prolonged placement. In addition to the relatively simple structure of a self-closing rubber stopper that utilizes its own elasticity to achieve self-sealing, the distal and proximal valves can also be designed as unidirectional valves that allow flow to the distal end. When the central structure of the valve body is subjected to the action of the injection guide needle, it can open distally to allow the injection guide needle to advance distally (inside the body), and when the injection guide needle is withdrawn proximally (outside the body), the central structure of the valve body automatically closes.

[0029] In one embodiment of the present invention, the distal end of the tube body 1 has an arc-shaped closed end and the drainage port 6 is provided on the side wall of the tube body 1.

[0030] Understandably, using a rounded, closed end at the distal end of the tube facilitates its insertion into the patient's body and avoids the tube tip scratching the urethra or bladder wall during insertion.

[0031] In one embodiment of this utility model, the dilating balloon 3 is elongated, with one end close to the imaging ring 7 and the other end close to the proximal end face of the tube body 1.

[0032] Understandably, when the proximal end of the dilation balloon is close to the proximal end face of the prostate, the inflated balloon itself is blocked by the external sphincter and is not easy to slip out of the prostate.

[0033] In one embodiment of this utility model, one end of the connecting rope 4 is fixedly connected to the proximal end face of the tube body 1, and the other end is fixedly connected to the fixing anchor 5.

[0034] It should be noted that the connecting rope is thin and flexible, and can be clamped by the external sphincter muscle at 50° to prevent urinary leakage.

[0035] In one embodiment of this utility model, the fixing anchor 5 is a bent and coiled metal wire or a flexible plastic sheet bent into an arc shape after being compressed.

[0036] It should be noted that when the metal wire is in a bundle, the traction rope and the connecting rope are connected to the two ends of the metal wire respectively. When the traction rope pulls the metal wire with a large force, the metal wire can change from a bundled structure to a straight shape, thus making it easier to pull out of the urethra. When the flexible plastic sheet is subjected to the radial compression force of the urethra, it bends into an arc shape, so that urine can pass through the arc-shaped channel and avoid the fixed anchor blocking the urethra.

[0037] In one embodiment of this utility model, the fixing anchor 5 is a flexible plastic sheet and is wedge-shaped with a larger distal end and a smaller proximal end. The distal end of the fixing anchor 5 is fixedly connected to the connecting rope 4, and the proximal end is connected to the other end of the traction rope 12 after passing through the center of the distal valve 10 and the proximal valve 11 in sequence and then connected to the balloon cavity 9.

[0038] In one embodiment of the present invention, a fixing block 13 is provided in the cavity, the fixing block 13 is fixedly connected to one end of the guide rope 14, and the other end of the guide rope 14 extends from the proximal end of the balloon cavity 9.

[0039] In one embodiment of this utility model, the limiting balloon 2 and the expansion balloon 3 are made of silicone or TPU, and the tube body 1 is made of silicone or TPU.

[0040] The surgical steps using the prostate balloon dilation catheter provided by this invention are briefly described below:

[0041] Surgical steps:

[0042] 1. Before the operation begins, the injection guide needle 15 (with an injection channel inside) is pushed forward along the guide rope outside the body (the distal end of the guide rope can be connected to a rigid and long thin guide wire so that the guide rope can pass through the injection guide needle). The tip of the injection guide needle 15 passes through the proximal valve 11 and the distal valve 10 in sequence.

[0043] 2. The instrument is placed into the bladder 20 via the urethra through the delivery system. The imaging ring 7 is observed to pass through the bladder neck 30 by external X-ray, which indicates that the limiting balloon 2 is completely placed in the bladder.

[0044] 3. Keeping the instrument stationary, connect the injection guide needle 15 (Luer connector) to the Y valve 16, and lock the main body of the Y valve 16. Figure 3 At the right end of the Y-valve 16, the inclined tube is connected to the syringe, and a certain amount of physiological saline is injected into the lumen. The liquid flows into the first segment of the lumen through the injection guide needle 15, and then into the limiting balloon, causing the limiting balloon to expand.

[0045] 4. Loosen the Y valve (the loosening should not be too large to avoid the injected liquid flowing out of the Y valve), and withdraw the infusion guide needle 15 outward (at this time, due to the restriction of the limiting balloon, the instrument will not move outward under the pulling action of the infusion guide needle). Move a distance of 2cm, and the distal valve will automatically close due to the elastic effect. The tip of the infusion guide needle will retract to the second cavity, lock the Y valve, and inject physiological saline into the infusion guide needle. The liquid flows into the second cavity through the infusion guide needle 15, and then into the dilation balloon, causing the dilation balloon to dilate.

[0046] 5. Remove segment two from the instrument. The proximal valve closes automatically, and the insertion procedure is completed. The dilation balloon dilates the prostate 40. The connecting rope 4 is located between the prostate 40 and the urethra 60 and passes through the external sphincter 50. Parts of the proximal ends of the guide rope 14 and the traction rope 12 remain outside the body.

[0047] When it is necessary to remove the prostate dilation catheter device provided by this utility model from the patient's body, the procedure is as follows:

[0048] 1. Insert the injection guide needle 15 into the balloon cavity 9 along the guide rope 14. When significant resistance is encountered and a large amount of liquid flows out of the injection guide needle, it indicates that the tip of the injection guide needle has passed through the proximal valve and reached the second cavity. The liquid in the dilatation balloon and the second cavity flows out through the injection guide needle. A syringe can be used to aspirate the liquid, causing the dilatation balloon to fully contract.

[0049] 2. Continue pushing the injection guide needle forward. When it encounters significant resistance and a large amount of liquid flows out of the injection guide needle again, it indicates that the tip of the injection guide needle has passed through the distal valve and reached the first cavity. The liquid in the limiting balloon and the first cavity flows out through the injection guide needle. A syringe can be used to aspirate the liquid, causing the limiting balloon to fully contract.

[0050] 3. Remove the infusion guide needle, pull the traction rope, and remove the device from the body to complete the entire treatment process.

[0051] The above description is only a preferred embodiment of the present utility model and is not intended to limit the present utility model. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present utility model should be included within the protection scope of the present utility model.

Claims

1. A prostate balloon dilation catheter, characterized in that, The device includes a tube body (1), a limiting balloon (2), a dilating balloon (3), a connecting rope (4), and a fixing anchor (5). The distal end of the tube body (1) is provided with a drainage port (6), and the proximal end is connected to the fixing anchor (5) via the connecting rope (4). The limiting balloon (2) and the dilating balloon (3) are fitted onto the tube body (1). The limiting balloon (2) is close to the distal end of the tube body (1), and the dilating balloon (3) is close to the proximal end of the tube body (1). A contrast ring (7) is provided on the section of the tube body (1) between the limiting balloon (2) and the dilating balloon (3). A urine drainage channel (8) and a balloon cavity (9) are provided axially inside the tube body (1). One end of the urine drainage channel (8) is connected to the drainage port (6) at the distal end of the tube body (1), and the other end is connected to the proximal tube opening of the tube body (1). The balloon cavity (9) is fixedly provided with a distal valve (10) and a proximal valve (11) at intervals along the axial direction. The balloon cavity (9) is connected to the limiting balloon (2) through a cavity segment one located on the side of the distal valve (10) near the drainage port (6). The balloon cavity (9) is connected to the dilating balloon (3) through a cavity segment two located between the distal valve (10) and the proximal valve (11). The distal valve (10) and the proximal valve (11) are both self-closing rubber plugs.

2. The prostate balloon dilation catheter according to claim 1, characterized in that, The distal end of the tube (1) has an arc-shaped closed end and the drainage port (6) is located on the side wall of the tube (1).

3. The prostate balloon dilation catheter according to claim 1, characterized in that, The dilating balloon (3) is elongated, with one end close to the imaging ring (7) and the other end close to the proximal end face of the tube body (1).

4. A prostate balloon dilation catheter according to claim 3, characterized in that, One end of the connecting rope (4) is fixedly connected to the near end face of the tube body (1), and the other end is fixedly connected to the fixing anchor (5).

5. A prostate balloon dilation catheter according to claim 1, characterized in that, The fixed anchor (5) is a bent and coiled metal wire or a flexible plastic sheet that is bent into an arc shape after being compressed.

6. A prostate balloon dilation catheter according to claim 5, characterized in that, The fixed anchor (5) is a flexible plastic sheet and is wedge-shaped with a larger distal end and a smaller proximal end. The distal end of the fixed anchor (5) is fixedly connected to the connecting rope (4), and the proximal end is connected to the other end of the traction rope (12) after passing through the center of the distal valve (10) and the proximal valve (11) in sequence, and then connected to the balloon cavity (9).

7. A prostate balloon dilation catheter according to claim 1, characterized in that, A fixing block (13) is provided inside the cavity, and the fixing block (13) is fixedly connected to one end of the guide rope (14), and the other end of the guide rope (14) extends from the proximal end of the balloon cavity (9).

8. A prostate balloon dilation catheter according to any one of claims 1 to 7, characterized in that, The limiting balloon (2) and the expansion balloon (3) are made of silicone or TPU, and the tube body (1) is made of silicone or polyurethane.

Images