Medicated balloon catheter for benign prostatic hyperplasia treatment

Abstract

This invention discloses a drug-eluting balloon catheter for the treatment of benign prostatic hyperplasia (BPH), belonging to the field of medical device technology. It includes a catheter, a pre-dilatation balloon, and a drug-eluting balloon connected to the end of the pre-dilatation balloon. Y-shaped needle hubs and elastic tips are connected to both ends of the catheter. The pre-dilatation balloon and the drug-eluting balloon are sequentially and fixedly connected to the side of the catheter near the elastic tip. The outer surface of the drug-eluting balloon is coated with a drug composition layer, and a scoring assembly is provided on the outer surface of the drug-eluting balloon. The scoring assembly includes a scoring element, a restraining ring, and a marking ring. The restraining ring is fitted at the connection between the pre-dilatation balloon and the drug-eluting balloon, and the marking ring is connected to the proximal end of the catheter near the drug-eluting balloon. Both ends of the scoring element are fixedly connected to the restraining ring and the marking ring, respectively. An adhesive platform allows the pre-dilatation balloon and the drug-eluting balloon to expand independently, and the micro-cracks formed by the scoring wires orderly expanding the prostatic urethra can improve the absorption efficiency of the drug coating.

Description

Technical Field

[0001] This invention belongs to the field of medical devices, specifically relating to a drug-eluting balloon catheter for the treatment of benign prostatic hyperplasia. Background Technology

[0002] The prostate is a gland in men located below the bladder and surrounding the urethra. In young men, the prostate is about the size of a walnut, but it enlarges with age. Due to the constricting effect of the prostate capsule, the enlarged prostate exerts increased pressure on the urethra, gradually compressing the posterior urethral lumen and obstructing urine flow. In men with benign prostatic hyperplasia (BPH), the bladder may not be completely emptied during urination, leading to urine stagnation and increasing the risk of urinary tract infections and bladder stones. Long-term obstruction can impair bladder function and eventually cause kidney damage. Surgical treatment is an option when conventional drug therapy is ineffective. Surgery can maximize symptom relief but can also cause complications. The most common surgical procedure is transurethral resection of the prostate (TURP), but complications include infection and bleeding. Approximately 1%-3% of men experience permanent urinary incontinence, and the surgery can also cause permanent erectile dysfunction. Due to the continued growth of the prostate, about 10% of men who undergo prostatectomy will require repeat surgery within 10 years. Most current treatment methods involve inserting instruments into the urethra, and the risk of complications is not low.

[0003] Transurethral balloon dilation of the prostate (TUCBDP) is an innovative surgical procedure for treating small-volume benign prostatic hyperplasia (BPH). By continuously inflating a balloon along the prostatic urethra, the prostatic capsule is gradually compressed, causing a rupture at a weak point. The enlarged prostatic tissue from both lobes is pushed outwards, and the dilated capsule is quickly filled by surrounding adipose tissue. This relieves the symptoms of BPH while preserving the prostate and normal ejaculatory function. However, the drug-eluting balloons used in TUCBDP sometimes accumulate in the folds of the prostatic urethra, resulting in only partial application of the medication to the balloon surface. This leads to poor long-term efficacy and slow therapeutic effect in inhibiting BPH. Furthermore, issues such as balloon positioning and catheter slippage during dilation need to be addressed.

[0004] Existing technologies disclose some patents for drug-eluting balloons used to treat prostate problems. Among them, invention patent CN118121817A discloses a balloon assembly for administering medication to the prostate, including a balloon catheter, a positioning balloon fixedly disposed at the distal end of the balloon catheter, and an olive-shaped balloon adjacent to and fixedly disposed on the balloon catheter… and such that when the sheath is retracted proximally relative to the balloon catheter, at least the positioning balloon and the olive-shaped balloon are exposed. While this addresses issues such as long surgical and postoperative hospital stays, significant bleeding, and a series of complications, problems still exist. During use, the medication accumulates in the folds of the prostatic urethra, resulting in only partial application of medication to the balloon surface. This leads to poor long-term therapeutic effects in inhibiting prostate hyperplasia, slow efficacy, time-consuming balloon positioning, and inaccurate balloon expansion.

[0005] In view of this, the inventors conducted in-depth research to address this need, which led to this case. Summary of the Invention

[0006] To overcome the problems of existing drug-eluting balloons, such as poor long-term therapeutic effects and slow efficacy due to drug accumulation in the folds of the prostatic urethra, resulting in only partial application of drug to the tissue, time-consuming positioning of the drug-eluting balloon, and inaccurate balloon expansion, this invention provides a drug-eluting balloon catheter for the treatment of benign prostatic hyperplasia. The catheter includes a catheter, a pre-expansion balloon, and a drug-eluting balloon connected to the end of the pre-expansion balloon. Y-shaped needle hubs and elastic tips are connected to both ends of the catheter. The pre-expansion balloon and the drug-eluting balloon are sequentially and fixedly connected to the side of the catheter near the elastic tip. The outer surface of the drug-eluting balloon is coated with a drug composition layer, and a scoring component is provided on the outer surface of the drug-eluting balloon.

[0007] The scoring assembly includes a scoring element, a restraint ring, and a marking ring. The scoring element is fixedly connected to the outside of the drug-eluting balloon. The restraint ring is sleeved at the connection between the pre-inflated balloon and the drug-eluting balloon. The marking ring is fixedly connected to the proximal end of the catheter located on the drug-eluting balloon. The two ends of the scoring element are fixedly connected to the restraint ring and the marking ring, respectively.

[0008] The pre-dilatation balloon and drug-eluting balloon are designed to anchor the balloon catheter, preventing balloon displacement and subsequent prostate damage. A restraint ring at the balloon neck limits its expansion, preventing excessive expansion that could damage the bladder neck. The outer surface of the drug-eluting balloon features a scoring component for cutting urethral strictures. This scoring component creates orderly micro-cracks within the prostatic urethra, increasing the contact area between the drug and tissue and significantly improving the absorption efficiency of the drug coating. Simultaneously, the scoring component also provides some anti-slip properties, preventing interference with normal prostate function.

[0009] Furthermore, the scoring component includes a first scoring wire, which is spirally wound and fixed to the outer surface of the drug capsule. The two ends of the first scoring wire are respectively connected to the constraint ring and the marking ring. The material of the first scoring wire is shape memory alloy or hard fiber. The first scoring wire is a triangular wire or a round flat wire.

[0010] Furthermore, the scoring element includes a plurality of second scoring wires arranged in the same direction as the catheter. The two ends of the second scoring wires are respectively connected to the constraint ring and the marking ring. The plurality of second scoring wires are equidistantly arranged on the outer surface of the drug balloon. The material of the second scoring wires is shape memory alloy or hard fiber. The second scoring wires are triangular wires or round flat wires.

[0011] The above technical solution uses a scoring wire to create orderly micro-fissures in the prostatic urethra without damaging the urethra. The drug composition layer on the surface of the drug balloon and its neck is absorbed through the micro-fissures in the urethra, allowing for more effective penetration into the prostatic hyperplasia tissue and exerting a therapeutic effect. Simultaneously, the scoring wire also provides some anti-slip properties.

[0012] Furthermore, the proximal end of the pre-dilatation balloon is integrally connected to an adhesive platform, which is connected to the outside of the catheter. The distal end of the drug-eluting balloon is bonded to the outside of the adhesive platform, and the distance of the adhesive platform along the length of the catheter is 1-3 mm.

[0013] Furthermore, the catheter includes an outer tube and an inner tube that passes through the inner lumen of the outer tube. An outer tube lumen is formed between the outer wall of the inner tube and the inner wall of the outer tube. The drug-eluting balloon communicates with the outer tube lumen, the pre-dilation balloon communicates with the inner tube, and the outer tube lumen is not communicated with the inner tube.

[0014] Furthermore, the Y-shaped needle hub includes a first injection port and a second injection port integrally connected to the catheter, the first injection port communicating with the outer tube cavity, and the second injection port communicating with the inner tube.

[0015] Furthermore, several inflation / deflation ports are evenly distributed in the middle of the outer wall of the inner tube encompassing the pre-expanded balloon.

[0016] Furthermore, the pharmaceutical composition layer comprises at least one of paclitaxel and rapamycin, and optionally a pharmaceutical carrier.

[0017] Furthermore, the marking ring is made of any one of gold, platinum, nickel-titanium alloy, or silicone doped with bright color masterbatch; the constraint ring is made of high-strength fiber or nickel-titanium alloy; and the elastic tip is made of silicone.

[0018] Furthermore, the pre-dilatation balloon is a compliant balloon, and the drug-eluting balloon is a non-compliant balloon or a low-compliant balloon.

[0019] Using the above technical solution, the drug-eluting balloon catheter is inserted into the urethral stricture lesion of benign prostatic hyperplasia (BPH) via a delivery system such as a cystoscope. The elastic tip and pre-dilatation balloon are inserted into the bladder, with the balloon neck positioned at the bladder neck. During the process, a marker ring confirms that the balloon assembly has reached the predetermined position. First, the pre-dilatation balloon is inflated through the second injection port to anchor the drug-eluting balloon catheter at the bladder neck. Then, the drug-eluting balloon is inflated through the first injection port, injecting physiological saline to expand it into a gourd-like shape, achieving dilation and drug release. The drug-eluting balloon neck is anchored at the bladder neck to prevent the balloon from slipping. The expansion of the prostatic urethral stricture by the drug-eluting balloon causes the prostatic capsule to rupture, pushing the hyperplastic prostatic tissue on both lobes outward to form a "tissue cushion," relieving the pressure of BPH on the urethra. The scoring wires create orderly microcracks in the prostatic urethra. The water-soluble drug coating on the surface of the balloon and balloon neck penetrates more effectively into the hyperplastic prostatic tissue through the microcracks in the urethra, exerting a therapeutic effect and preventing BPH from compressing the urethra again. Beneficial effects

[0020] The beneficial effects of adopting the technical solution of this invention are as follows:

[0021] (1) By splicing the pre-dilation balloon and the drug balloon together, the balloon catheter can be well anchored to prevent balloon displacement and dilation from causing prostate damage. A restraint ring is set at the balloon neck to better restrain the dilation size of the balloon neck and prevent excessive dilation of the balloon neck from damaging the bladder neck. The pre-dilation balloon and the drug balloon are firmly connected by the bonding platform, and the two balloons can be dilated independently for treatment. By setting the scoring wire on the surface of the drug balloon, micro-cracks can be formed in the prostatic urethra during the dilation of the drug balloon, increasing the contact area of ​​the drug with the tissue and improving the absorption efficiency of the drug coating, thereby improving the long-term therapeutic effect of inhibiting prostatic hyperplasia. At the same time, the scoring wire also plays a certain role in anti-slip and avoids affecting the normal function of the prostate.

[0022] (2) By setting scoring wires on the surface of the drug balloon, micro-cracks can be formed in the prostatic urethra during the expansion of the drug balloon, increasing the contact area of ​​the drug with the tissue, improving the absorption efficiency of the drug coating, and more effectively penetrating into the prostatic hyperplasia tissue to exert a therapeutic effect. At the same time, the scoring wires also play a certain role in preventing slippage and avoiding affecting the normal function of the prostate.

[0023] (3) During the treatment process, the pre-dilation balloon and the drug balloon are simply introduced into the corresponding position of the prostatic urethra and dilated to complete the surgery. The treatment process is simple and safe. The pre-dilation balloon and the drug balloon are connected to the inner lumen and the outer lumen, respectively. The two balloons are injected through the first injection port and the second injection port to increase the pressure. The pressure increase is completely independent, which is highly controllable, easy to locate, and greatly shortens the operation time. Attached Figure Description

[0024] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained from these drawings without creative effort.

[0025] Figure 1 This is a schematic diagram of the structure of a drug-eluting balloon catheter for the treatment of benign prostatic hyperplasia according to the present invention;

[0026] Figure 2 This is a schematic diagram of a drug-eluting balloon catheter pre-dilation balloon for the treatment of benign prostatic hyperplasia according to the present invention;

[0027] Figure 3 This is a schematic diagram of the first notched wire of a drug-eluting balloon catheter for the treatment of benign prostatic hyperplasia according to the present invention;

[0028] Figure 4 This is a schematic diagram of the second notched wire of a drug-eluting balloon catheter for the treatment of benign prostatic hyperplasia according to the present invention;

[0029] Figure 5 This is a diagram showing the positional relationship of the second notched wire in a drug-eluting balloon catheter for the treatment of benign prostatic hyperplasia according to the present invention.

[0030] Figure 6 This is a schematic diagram showing the position of the first notched wire of a drug-eluting balloon catheter for the treatment of benign prostatic hyperplasia according to the present invention;

[0031] Figure 7 This is a schematic diagram of the uninflated state of a drug balloon catheter for the treatment of benign prostatic hyperplasia according to the present invention;

[0032] Figure 8 This is a schematic diagram of the state of a drug balloon catheter used for the treatment of benign prostatic hyperplasia during inflatation according to the present invention;

[0033] Figure 9 This invention relates to a triangular wire of a drug-eluting balloon catheter for the treatment of benign prostatic hyperplasia.

[0034] Figure 10 This is a schematic diagram of the round, flat wire of a drug-eluting balloon catheter for the treatment of benign prostatic hyperplasia according to the present invention;

[0035] In the diagram, 1. Catheter; 2. Pre-dilation balloon; 3. Drug-eluting balloon; 4. Y-shaped needle hub; 5. Elastic tip; 6. Drug composition layer; 7. Score assembly; 8. Restraint ring; 9. Marking ring; 10. First score wire; 11. Second score wire; 12. Adhesion platform; 13. Outer tube; 14. Inner tube; 15. Outer tube lumen; 16. First injection port; 17. Second injection port; 18. Inflation / depression port; 19. Bladder; 20. Urethra. Detailed Implementation

[0036] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, not all of them. Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to represent selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0037] This embodiment employs a spliced ​​setup of a pre-dilatation balloon and a drug-eluting balloon. This effectively anchors the balloon catheter, preventing balloon displacement and subsequent prostate damage during dilation. The restraint ring better controls the dilation size of the balloon neck. An adhesive platform allows the two balloons to dilate independently for treatment. Adding scoring wires to the surface of the drug-eluting balloon increases the drug contact area with tissue, improving the absorption efficiency of the drug coating and enhancing the long-term therapeutic effect in inhibiting benign prostatic hyperplasia. The specific implementation method is as follows:

[0038] like Figure 1-10 As shown, a drug-eluting balloon catheter for the treatment of benign prostatic hyperplasia includes a catheter 1, a pre-dilatation balloon 2, and a drug-eluting balloon 3 connected to the end of the pre-dilatation balloon 2. The two ends of the catheter 1 are respectively connected to a Y-shaped needle hub 4 and an elastic tip 5. The pre-dilatation balloon 2 and the drug-eluting balloon 3 are sequentially fixedly connected to the side of the catheter 1 near the elastic tip 5. The outer surface of the drug-eluting balloon 3 is coated with a drug composition layer 6, and the outer surface of the drug-eluting balloon 3 is provided with a scoring component 7.

[0039] The scoring assembly 7 includes a scoring element, a restraint ring 8, and a marking ring 9. The scoring element is fixedly connected to the outside of the drug-eluting balloon 3. The restraint ring 8 is sleeved at the connection between the pre-dilated balloon 2 and the drug-eluting balloon 3. The marking ring 9 is fixedly connected to the proximal end of the catheter 1 located on the drug-eluting balloon 3. The two ends of the scoring element are fixedly connected to the restraint ring 8 and the marking ring 9, respectively.

[0040] Here, a pre-dilatation balloon 2 and a drug-eluting balloon 3 are spliced ​​together to anchor the balloon catheter 1 and prevent balloon displacement and dilation from causing prostate damage. A restraint ring 8 is set at the balloon neck to restrain the dilation size of the balloon neck and prevent excessive dilation of the balloon neck from damaging the bladder neck 19. A scoring component 7 is set on the outer surface of the drug-eluting balloon 3 to cut the narrow position of the urethra 20. The scoring component 7 forms orderly microcracks in the prostatic urethra 20, increasing the contact area between the drug and the tissue and greatly improving the absorption efficiency of the drug coating. At the same time, the scoring component 7 also plays a certain role in anti-slip and avoids affecting the normal function of the prostate.

[0041] Here, the drug-eluting balloon 3 is made of Pebax or PA, the pre-dilation balloon 2 is made of TPU, and the drug-eluting balloon 3 is designed to be streamlined. This shape matches the shape of the prostatic urethra 20 in a healthy state, so that the prostatic urethra 20 can be properly dilated, and drug can be administered through contact to inhibit prostatic hyperplasia and prevent damage to the external sphincter of the urethra 20.

[0042] In a preferred embodiment, the scoring element includes a first scoring wire 10, which is spirally wound and fixed to the outer surface of the drug capsule 3. The two ends of the first scoring wire 10 are connected to the constraint ring 8 and the marking ring 9, respectively. The material of the first scoring wire 10 is shape memory alloy or hard fiber. The first scoring wire 10 is a triangular wire or a round flat wire.

[0043] In a preferred embodiment, the scoring element includes a plurality of second scoring wires 11 arranged in the same direction as the catheter 1. The two ends of the second scoring wires 11 are connected to the constraint ring 8 and the marking ring 9, respectively. The plurality of second scoring wires 11 are equidistantly arranged on the outer surface of the drug balloon 3. The material of the second scoring wires 11 is shape memory alloy or hard fiber. The second scoring wires 11 are triangular wires or round flat wires.

[0044] Here, the scoring wire creates orderly micro-slits in the prostatic urethra without damaging the urethra. The drug composition layer on the surface of the drug balloon and its neck is absorbed through the micro-slits in the urethra, allowing for more effective penetration into the prostatic hyperplasia tissue to exert a therapeutic effect and prevent prostatic restenosis. The scoring wire also provides some anti-slip properties.

[0045] In a preferred embodiment, the proximal end of the pre-dilatation balloon 2, near the end of the drug-eluting balloon 3, is integrally connected to an adhesive platform 12. The adhesive platform 12 is connected to the outside of the catheter 1, and the distal end of the drug-eluting balloon 3 is bonded to the outside of the adhesive platform 12. The adhesive platform 12 is 1-3 mm long along the catheter 1.

[0046] Here, the bonding platform 12 is an inverted cone shape, and an bonding ring extends from the bonding platform 12 to the pre-expanded balloon 2. The drug-eluting balloon 3 is fixedly connected to the bonding ring. The outer layer is part of the drug-eluting balloon 3, and the inner layer is part of the pre-expanded balloon 2. The connection between the two forms the balloon neck.

[0047] In a preferred embodiment, the catheter 1 includes an outer tube 13 and an inner tube 14 that passes through the inner lumen of the outer tube 13. An outer tube lumen 15 is formed between the outer wall of the inner tube 14 and the inner wall of the outer tube 13. The drug-eluting balloon 3 communicates with the outer tube lumen 15, and the pre-dilation balloon 2 communicates with the inner tube 14. The outer tube lumen 15 is not communicated with the inner tube 14. The proximal end of the drug-eluting balloon 3 is connected to the outer wall of the outer tube 13, and the distal end of the pre-dilation balloon 2 is connected to the outside of the inner tube 14.

[0048] In a preferred embodiment, the Y-type needle hub 4 includes a first injection port 16 and a second injection port 17 integrally connected to the catheter 1. The first injection port 16 communicates with the outer tube cavity 15, and the second injection port 17 communicates with the inner tube 14.

[0049] Here, the surgery can be completed simply by bringing the pre-dilatation balloon 2 in the balloon assembly into contact with and dilating the prostatic urethra 20 that is wrapped around the prostate. The treatment process is simple and safe. The pre-dilatation balloon 2 and the drug-eluting balloon 3 are connected separately to the inner tube 14 and the outer tube lumen 15, respectively. The two balloons are pressurized by injection through the first injection port 16 and the second injection port 17, respectively. The pressurization is carried out completely independently, which is highly controllable, easy to position, and greatly shortens the operation time.

[0050] In a preferred embodiment, a plurality of inflation / deflation ports 18 are evenly provided in the middle of the outer wall of the inner tube 14 encompassing the pre-expanded balloon 2.

[0051] In a preferred embodiment, the pharmaceutical composition layer 6 includes at least one of paclitaxel and rapamycin, and optionally a pharmaceutical carrier.

[0052] Here, the outer walls of the constraint ring 8 and the drug balloon 3 are coated with a drug coating.

[0053] In a preferred embodiment, the distance between the marking ring 9 and the end of the drug capsule 3 is 5-6 mm. The marking ring 9 is made of any one of gold, platinum, nickel-titanium alloy, or silicone doped with bright color masterbatch. The constraint ring 8 is made of high-strength fiber or nickel-titanium alloy, and the elastic tip 5 is made of silicone.

[0054] Here, the restraint ring 8 can be made of high-strength fibers such as ultra-high density polyethylene or nickel-titanium alloy rings, and its surface is coated with a water-soluble drug coating for treating benign prostatic hyperplasia, such as paclitaxel.

[0055] In a preferred embodiment, the pre-dilatation balloon 2 is a compliant balloon, and the drug-eluting balloon 3 is a non-compliant balloon or a low-compliant balloon.

[0056] Here, setting the pre-dilation balloon 2 as a compliant balloon ensures that the prostate will not be damaged during the inflation process, while setting the drug-eluting balloon 3 as a non-compliant or low-compliant balloon ensures that the drug-eluting balloon 3 has better dimensional stability after inflation, and can better dilate the urethra 20 so that the drug on the surface of the drug-eluting balloon 3 can fully contact the inside of the urethra.

[0057] Here, the drug-eluting balloon 3, via a delivery system including a cystoscope (19), enters the stenotic lesion of the prostatic hyperplasia urethra 20. The elastic tip and pre-dilatation balloon 2 enter the bladder (19), with the balloon neck positioned at the neck of the bladder (19). During the process, a marker ring (9) confirms that the balloon assembly has reached the predetermined position. First, the pre-dilatation balloon 2 is inflated through the second injection port (17) to anchor the drug-eluting balloon 3, via the second injection port (17), at the neck of the bladder (19). Then, the drug-eluting balloon 3 is inflated through the first injection port (16) and injected with saline solution, expanding into a gourd-like shape to facilitate dilation and drug release. The neck of the drug-eluting balloon 3 is anchored at the neck of the bladder (19) to prevent slippage. The expansion of the stenotic urethra 20 by the drug-eluting balloon 3 causes the prostatic capsule to rupture, pushing the hyperplastic prostatic tissue on both lobes outward to form a "tissue cushion," relieving the pressure of the prostatic hyperplasia on the urethra 20. The scoring wires create orderly micro-cracks in the prostatic urethra 20. The water-soluble drug coating on the surface of the drug-eluting balloon 3 and the balloon neck can penetrate more effectively into the prostatic hyperplasia tissue through the micro-cracks in the urethra 20, exerting a therapeutic effect and preventing the prostatic hyperplasia from compressing the urethra 20 again.

[0058] Here, the proximal end usually refers to the end of the medical device that is closer to the operator during operation; the distal end usually refers to the end of the medical device that first enters the patient's body during normal operation, that is, the end that is farther away from the operator.

[0059] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. For those skilled in the art, the present invention can have various modifications and variations. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A drug-eluting balloon catheter for the treatment of benign prostatic hyperplasia, characterized in that, The device includes a catheter (1), a pre-expanding balloon (2), and a drug-eluting balloon (3) connected to the end of the pre-expanding balloon (2). The catheter (1) is connected to a Y-shaped needle hub (4) and an elastic tip (5) at both ends. The pre-expanding balloon (2) and the drug-eluting balloon (3) are sequentially fixedly connected to the side of the catheter (1) near the elastic tip (5). The outer surface of the drug-eluting balloon (3) is coated with a drug composition layer (6), and the outer surface of the drug-eluting balloon (3) is provided with a scoring component (7). The scoring assembly (7) includes a scoring element, a restraint ring (8) and a marking ring (9). The scoring element is fixedly connected to the outside of the drug balloon (3). The restraint ring (8) is sleeved at the connection between the pre-dilated balloon (2) and the drug balloon (3). The marking ring (9) is fixedly connected to the proximal end of the catheter (1) located on the drug balloon (3). The two ends of the scoring element are fixedly connected to the restraint ring (8) and the marking ring (9) respectively. The proximal end of the pre-dilatation balloon (2) is integrally connected to an adhesive platform (12), which is connected to the outside of the catheter (1). The distal end of the drug-eluting balloon (3) is bonded to the outside of the adhesive platform (12), and the adhesive platform (12) is 1-3 mm long along the catheter (1).

2. The drug-eluting balloon catheter for treating benign prostatic hyperplasia according to claim 1, characterized in that, The scoring component includes a first scoring wire (10), which is spirally wound and fixed to the outer surface of the drug capsule (3). The two ends of the first scoring wire (10) are respectively connected to the constraint ring (8) and the marking ring (9). The material of the first scoring wire (10) is shape memory alloy or hard fiber. The first scoring wire (10) is a triangular wire or a round flat wire.

3. A drug-eluting balloon catheter for the treatment of benign prostatic hyperplasia according to claim 1, characterized in that, The scoring element includes several second scoring wires (11) arranged in the same direction as the catheter (1). The two ends of the second scoring wires (11) are connected to the constraint ring (8) and the marking ring (9) respectively. Several second scoring wires (11) are equidistantly arranged on the outer surface of the drug balloon (3). The material of the second scoring wires (11) is shape memory alloy or hard fiber. The second scoring wires (11) are triangular wires or round flat wires.

4. A drug-eluting balloon catheter for the treatment of benign prostatic hyperplasia according to claim 1, characterized in that, The catheter (1) includes an outer tube (13) and an inner tube (14) that passes through the inner lumen of the outer tube (13). An outer tube cavity (15) is formed between the outer wall of the inner tube (14) and the inner wall of the outer tube (13). The drug balloon (3) is connected to the outer tube cavity (15). The pre-dilation balloon (2) is connected to the inner tube (14). The outer tube cavity (15) is not connected to the inner tube (14).

5. A drug-eluting balloon catheter for the treatment of benign prostatic hyperplasia according to claim 4, characterized in that, The Y-shaped needle hub (4) includes a first injection port (16) and a second injection port (17) integrally connected to the catheter (1). The first injection port (16) is connected to the outer tube cavity (15), and the second injection port (17) is connected to the inner tube (14).

6. A drug-eluting balloon catheter for the treatment of benign prostatic hyperplasia according to claim 4, characterized in that, A plurality of inflation and deflation ports (18) are evenly provided in the middle of the outer wall of the inner tube (14) enclosed inside the pre-expanded balloon (2).

7. A drug-eluting balloon catheter for the treatment of benign prostatic hyperplasia according to claim 1, characterized in that, The pharmaceutical composition layer (6) includes at least one of paclitaxel and rapamycin, and optionally a pharmaceutical carrier.

8. A drug-eluting balloon catheter for the treatment of benign prostatic hyperplasia according to claim 1, characterized in that, The marking ring (9) is made of any one of gold, platinum, nickel-titanium alloy, or silicone doped with bright color masterbatch, the constraint ring (8) is made of high-strength fiber or nickel-titanium alloy, and the elastic tip (5) is made of silicone.

9. A drug-eluting balloon catheter for the treatment of benign prostatic hyperplasia according to claim 1, characterized in that, The pre-expanded balloon (2) is a compliant balloon, and the drug-eluting balloon (3) is a non-compliant balloon or a low-compliant balloon.

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