Drug balloon catheter for treating benign prostatic hyperplasia

Abstract

The invention discloses a medicine balloon catheter for treating benign prostatic hyperplasia, and belongs to the technical field of medical instruments, the medicine balloon catheter comprises a catheter, a pre-expansion balloon and a medicine balloon connected with the end part of the pre-expansion balloon, the two ends of the catheter are respectively connected with a Y-shaped needle seat and an elastic tip, the pre-dilation balloon and the medicine balloon are sequentially and fixedly connected to the side, close to the elastic tip end, of the catheter, the outer surface of the medicine balloon is coated with a medicine composition layer, and a nicking assembly is arranged on the outer surface of the medicine balloon; the nicking assembly comprises a nicking piece, a restraining ring and a marking ring, the restraining ring is arranged at the joint of the pre-dilation balloon and the medicine balloon in a sleeving mode, the marking ring is connected to the catheter and located at the near end of the medicine balloon, and the two ends of the nicking piece are fixedly connected with the restraining ring and the marking ring respectively. The bonding platform enables the pre-dilation balloon and the medicine balloon to dilate respectively, and the micro-cracks formed by orderly dilation of the prostatic urethra by the nick wires can improve the absorption efficiency of the medicine coating.

Description

Technical Field

[0001] The invention belongs to the field of medical devices, and in particular relates to a drug balloon catheter for treating benign prostatic hyperplasia. Background Art

[0002] The prostate is a gland in men that is located below the bladder and surrounds the urethra. The prostate of young people is the size of a walnut, but it will increase with age. Due to the restraint of the prostate capsule, the enlarged prostate will increase the squeezing force on the urethra, and it will gradually compress the posterior urethral cavity and hinder the discharge of urine. When patients with prostatic hyperplasia urinate, the urine in the bladder may not be completely emptied, and the urine will stagnate in the bladder, which is easy to cause urinary tract infection and bladder stones. Long-term obstruction can damage bladder function and eventually lead to kidney damage. When conventional drug treatment is ineffective, surgical treatment can be selected. Surgery can relieve symptoms to the greatest extent, but it can also cause complications. The most common surgical method is transurethral prostatectomy, but complications of prostatectomy may include infection and bleeding. About 1%-3% of men will have permanent urinary incontinence. This operation can also cause permanent erectile dysfunction. Because of the continued growth of the prostate, about 10% of men who undergo prostatectomy need to undergo surgery again within 10 years. Most of the existing treatments are to insert instruments into the urethra for operation, and the risk of complications is not low.

[0003] Transurethral cylindrical balloon dilatation of the prostate (TUCBDP) is an innovative surgical method for treating small-volume prostatic hyperplasia. The prostatic urethra segment is pressurized and squeezed continuously to cause the weak part of the prostatic capsule to rupture, and the hyperplastic prostatic tissue of both lobes is pushed outward. The expanded prostatic capsule is quickly filled with surrounding fat tissue, which relieves the symptoms of prostatic hyperplasia and preserves the patient's prostate and normal ejaculation function. However, the drug balloon used in TUCBDP is only applied to part of the tissue due to the accumulation of wrinkles in the prostate urethra. The long-term treatment effect of inhibiting prostatic hyperplasia is poor and the effect is slow. In addition, the positioning of the drug balloon and the slippage of the catheter during expansion need to be solved.

[0004] Patents for drug balloons for treating prostates are disclosed in the prior art. Among them, the invention patent with the announcement number CN118121817A discloses a balloon assembly for administering drugs to the prostate, including a balloon catheter, a positioning balloon fixedly arranged at the distal end of the balloon catheter, and an olive-shaped balloon adjacent to the positioning balloon and fixedly arranged on the balloon catheter... and when the sheath is withdrawn proximally relative to the balloon catheter, at least the positioning balloon and the olive-shaped balloon are exposed. Although the problems of long operation and postoperative hospitalization time, heavy bleeding, and a series of complications are solved, there are still problems in reality that when the drug balloon is used, the drug on the balloon surface is only applied to part of the tissue due to the accumulation of wrinkles in the urethra in the prostate, and the long-term treatment effect of inhibiting prostate hyperplasia is poor and slow, the positioning of the drug balloon is time-consuming, and the balloon expansion degree is not accurate.

[0005] In view of this, the inventor conducted in-depth research on this demand, which resulted in this case. Summary of the invention

[0006] In order to overcome the problems in the prior art that the drug balloon in the prior art is used, the drug on the balloon surface is only applied to part of the tissue due to the accumulation of wrinkles in the prostate urethra, the long-term treatment effect of inhibiting prostate hyperplasia is poor, the effect is slow, the positioning of the drug balloon is time-consuming, and the balloon expansion degree is not accurate, the present invention provides a drug balloon catheter for the treatment of benign prostate hyperplasia, including a catheter, a pre-expansion balloon and a drug balloon connected to the end of the pre-expansion balloon, the two ends of the catheter are respectively connected to a Y-shaped needle seat and an elastic tip, the pre-expansion balloon and the drug balloon are fixedly connected to one side of the catheter close to the elastic tip in sequence, the outer surface of the drug balloon is coated with a drug composition layer, and the outer surface of the drug balloon is provided with a scoring component;

[0007] The scoring assembly includes a scoring piece, a constraint ring and a marking ring. The scoring piece is fixedly connected to the outside of the drug balloon, the constraint ring is sleeved at the connection between the pre-expansion balloon and the drug balloon, the marking ring is fixedly connected to the catheter at the proximal end of the drug balloon, and the two ends of the scoring piece are fixedly connected to the constraint ring and the marking ring respectively.

[0008] The pre-expanded balloon and the drug balloon are spliced ​​and arranged to anchor the balloon catheter to prevent the prostate damage caused by the balloon displacement and expansion. A constraint ring is arranged on the neck of the balloon to constrain the expansion size of the neck of the balloon to prevent the neck of the balloon from over-expanding and damaging the bladder neck of the human body. A notched component for cutting the urethral stricture is arranged on the outer surface of the drug balloon. The notched component forms orderly microcracks in the prostatic urethra, increases the contact area between the drug and the tissue, and can greatly improve the absorption efficiency of the drug coating. At the same time, the notched component also plays a certain anti-slip role to avoid affecting the normal function of the prostate.

[0009] Furthermore, the scoring part includes a first scoring wire, which is spirally wound and fixed on the outer surface of the drug balloon, and 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, and the first scoring wire is a triangular wire or a round flat wire.

[0010] Furthermore, the scoring member 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, and 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, and the second scoring wires are triangular wires or round flat wires.

[0011] Through the above technical solution, the scoring wire can score the prostatic urethra to form orderly microcracks without damaging the urethra. The drug balloon and the drug composition layer on the surface of the balloon neck are absorbed through the microcracks of the urethra and more effectively penetrate into the prostatic hyperplasia tissue to play a therapeutic role. At the same time, the scoring wire also plays a certain anti-slip role.

[0012] Furthermore, the proximal end of the pre-dilation balloon is integrally connected with a bonding platform, the bonding platform is connected to the outside of the catheter, the distal end of the drug balloon is bonded to the outside of the bonding platform, and the bonding platform is 1-3 mm along the length of the catheter.

[0013] Furthermore, the catheter includes an outer tube and an inner tube inserted into the inner cavity 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 balloon is connected to the outer tube lumen, the pre-expansion balloon is connected to the inner tube, and the outer tube lumen is not connected to the inner tube.

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

[0015] Furthermore, a plurality of pressure-inflating and pressure-releasing ports are evenly opened in the middle of the outer wall of the inner tube included in the pre-expansion balloon.

[0016] Furthermore, the drug composition layer includes at least one of paclitaxel and rapamycin, and an optional drug carrier.

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

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

[0019] Through the above technical scheme, the drug balloon catheter enters the urethral stricture lesion of prostatic hyperplasia through a delivery system such as a cystoscope, the elastic tip and the pre-expansion balloon enter the bladder, and the balloon neck is located at the bladder neck. During the process, the marking ring is used to confirm whether the balloon assembly has reached the predetermined position. The pre-expansion balloon is first filled through the second injection port to anchor the drug balloon catheter at the bladder neck, and then the drug balloon is filled through the first injection port and injected with saline to expand into a gourd shape, which plays a role in expansion and drug release. The neck of the drug balloon is anchored at the bladder neck to prevent the drug balloon from slipping. The stricture of the prostatic urethra is expanded by the drug balloon, causing the prostate capsule to split, and the prostatic tissue of the two lobes is pushed outward to form a "tissue pad", which relieves the pressure of prostatic hyperplasia on the urethra. The scoring wire forms orderly microcracks on the prostatic urethra. The water-soluble drug coating on the surface of the drug balloon and the balloon neck penetrates into the prostatic hyperplasia tissue more effectively through the microcracks of the urethra, exerts a therapeutic effect, and prevents prostatic hyperplasia from compressing the urethra again.

[0020] Beneficial effects:

[0021] The beneficial effects produced by the technical solution of the present invention are as follows:

[0022] (1) The pre-dilation balloon and the drug balloon are spliced ​​together to anchor the balloon catheter well to prevent the balloon from shifting and expanding and causing prostate damage. A constraint ring is set on the balloon neck to better constrain the expansion size of the balloon neck and prevent the balloon neck from over-expanding and damaging the bladder neck of the human body. The pre-dilation balloon and the drug balloon are firmly connected through a bonding platform, and the two balloons can be expanded independently for treatment. Score wires are set on the surface of the drug balloon to form microcracks in the prostate urethra when the drug balloon is expanded, thereby increasing the area of ​​drug contact with tissue, improving the absorption efficiency of the drug coating, and improving the long-term treatment effect of inhibiting prostate hyperplasia. At the same time, the score wire also plays a certain anti-slip role to avoid affecting the normal function of the prostate.

[0023] (2) By setting notched wires on the surface of the drug balloon, microcracks can be formed in the prostatic urethra when the drug balloon is expanded to increase the area of ​​drug contact with tissue, improve the absorption efficiency of the drug coating, and more effectively penetrate into the prostatic hyperplasia tissue to play a therapeutic role. At the same time, the notched wire also plays a certain anti-slip role to avoid affecting the normal function of the prostate.

[0024] (3) During the treatment process, the operation can be completed by only introducing the pre-dilation balloon and the drug balloon into the corresponding position of the prostatic urethra and expanding and contacting them. The treatment process is simple and safe. The pre-dilation balloon and the drug balloon are separately connected to the inner lumen and the outer lumen. The two balloons are injected and pressurized separately through the first injection port and the second injection port, and the pressurization is completely independent. It is highly controllable and easy to position, which greatly shortens the operation time. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without paying creative work.

[0026] Figure 1 It is a schematic structural diagram of a drug balloon catheter for treating benign prostatic hyperplasia of the present invention;

[0027] Figure 2 It is a schematic diagram of a pre-dilation balloon of a drug balloon catheter for treating benign prostatic hyperplasia of the present invention;

[0028] Figure 3 It is a schematic diagram of the first notched wire of a drug balloon catheter for treating benign prostatic hyperplasia of the present invention;

[0029] Figure 4 It is a schematic diagram of the second notched wire of a drug balloon catheter for treating benign prostatic hyperplasia of the present invention;

[0030] Figure 5 It is a position relationship diagram of the second notched wire of a drug balloon catheter for treating benign prostatic hyperplasia of the present invention;

[0031] Figure 6 It is a schematic diagram of the position of the first notch wire of a drug balloon catheter for treating benign prostatic hyperplasia of the present invention;

[0032] Figure 7 It is a schematic diagram of a drug balloon catheter for treating benign prostatic hyperplasia of the present invention when it is not pressurized;

[0033] Figure 8 It is a schematic diagram of the state of a drug balloon catheter for treating benign prostatic hyperplasia of the present invention when being pressurized;

[0034] Fig. 9 This is the intention of the triangular wire of a drug balloon catheter for treating benign prostatic hyperplasia of the present invention;

[0035] Fig.10 It is a schematic diagram of a round flat wire of a drug balloon catheter for treating benign prostatic hyperplasia of the present invention;

[0036] In the figure, 1. catheter; 2. pre-dilation balloon; 3. drug balloon; 4. Y-shaped needle seat; 5. elastic tip; 6. drug composition layer; 7. notched component; 8. restraint ring; 9. marking ring; 10. first notched wire; 11. second notched wire; 12. bonding platform; 13. outer tube; 14. inner tube; 15. outer tube lumen; 16. first injection port; 17. second injection port; 18. inflation and relief port; 19. bladder; 20. urethra. DETAILED DESCRIPTION

[0037] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Therefore, the following detailed description of the embodiments of the present invention provided in the drawings is not intended to limit the scope of the claimed invention, but merely represents the selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0038] This embodiment adopts the splicing arrangement of the pre-expanded balloon and the drug balloon, which can well anchor the balloon catheter to prevent the prostate damage caused by the balloon displacement and expansion. The constraint ring can better constrain the expansion size of the balloon neck. The bonding platform enables the two balloons to independently complete the expansion for treatment. The scoring wire is set on the surface of the drug balloon to increase the drug contact tissue area, improve the absorption efficiency of the drug coating, and improve the long-term treatment effect of inhibiting prostate hyperplasia. The specific implementation is as follows:

[0039] like Figure 1-10 As shown, a drug balloon catheter for treating benign prostatic hyperplasia comprises a catheter 1, a pre-expansion balloon 2 and a drug balloon 3 connected to the end of the pre-expansion balloon 2, two ends of the catheter 1 are respectively connected to a Y-shaped needle seat 4 and an elastic tip 5, the pre-expansion balloon 2 and the drug balloon 3 are sequentially fixedly connected to one side of the catheter 1 close to the elastic tip 5, the outer surface of the drug balloon 3 is coated with a drug composition layer 6, and the outer surface of the drug balloon 3 is provided with a scoring component 7;

[0040] The scoring assembly 7 includes a scoring piece, a constraint ring 8 and a marking ring 9. The scoring piece is fixedly connected to the outside of the drug balloon 3. The constraint ring 8 is sleeved on the connection between the pre-expansion balloon 2 and the drug balloon 3. The marking ring 9 is fixedly connected to the catheter 1 at the proximal end of the drug balloon 3. The two ends of the scoring piece are fixedly connected to the constraint ring 8 and the marking ring 9 respectively.

[0041] Here, the pre-expansion balloon 2 and the drug balloon 3 are spliced ​​and arranged to anchor the balloon catheter 1 to prevent the prostate damage caused by the displacement and expansion of the balloon. The constraint ring 8 is arranged on the neck of the balloon to constrain the expansion size of the neck of the balloon to prevent the neck of the balloon from over-expanding and damaging the neck of the bladder 19 of the human body. A notch component 7 for cutting the narrow position of the urethra 20 is arranged on the outer surface of the drug balloon 3. The notch component 7 forms orderly microcracks in the prostatic urethra 20, increasing the contact area between the drug and the tissue, which can greatly improve the absorption efficiency of the drug coating. At the same time, the notch component 7 also plays a certain anti-slip role to avoid affecting the normal function of the prostate.

[0042] Here, the material of the drug balloon 3 is Pebax or PA, the material of the pre-expansion balloon 2 is TPU, and the drug balloon 3 is set 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 expanded, and the prostate can be inhibited from regrowth and the external sphincter of the urethra 20 can be prevented from being damaged by contact drug administration.

[0043] As a preferred embodiment, the scoring part includes a first scoring wire 10, which is spirally wound and fixed on the outer surface of the drug balloon 3, and 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, and the first scoring wire 10 is a triangular wire or a round flat wire.

[0044] As a preferred embodiment, the scoring member 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 respectively connected to the constraint ring 8 and the marking ring 9, and 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, and the second scoring wires 11 are triangular wires or round flat wires.

[0045] Here, the scoring wire is used to score the prostatic urethra to form orderly microcracks without damaging the urethra. The drug balloon and the drug composition layer on the surface of the balloon neck are absorbed through the microcracks of the urethra and more effectively penetrate into the prostatic hyperplasia tissue to play a therapeutic role and prevent the prostate from restenosis. At the same time, the scoring wire also plays a certain anti-slip role.

[0046] As a preferred embodiment, the proximal end of the pre-dilation balloon 2 is integrally connected to one end of the drug balloon 3 with a bonding platform 12, the bonding platform 12 is connected to the outside of the catheter 1, and the distal end of the drug balloon 3 is bonded to the outside of the bonding platform 12, and the bonding platform 12 is 1-3 mm along the length of the catheter 1.

[0047] Here, the bonding platform 12 is an inverted cone, and a bonding ring extends from the connection between the bonding platform 12 and the pre-expansion balloon 2. The drug balloon 3 is fixedly connected to the bonding ring. The outer layer is the drug balloon 3 part and the inner layer is the pre-expansion balloon 2 part. The connecting part of the two forms the balloon neck.

[0048] As a preferred embodiment, the catheter 1 includes an outer tube 13 and an inner tube 14 inserted into the inner cavity 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 balloon 3 is connected to the outer tube lumen 15, the pre-dilation balloon 2 is connected to the inner tube 14, and the outer tube lumen 15 is not connected to the inner tube 14, the proximal end of the drug 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.

[0049] As a preferred embodiment, 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 lumen 15 , and the second injection port 17 is connected to the inner tube 14 .

[0050] Here, the operation can be completed only by making the pre-dilation balloon 2 in the balloon assembly contact and expand the prostatic urethra 20 wrapped in the prostate. The treatment process is simple and safe. The pre-dilation balloon 2 and the drug balloon 3 are separately connected to the inner tube 14 and the outer tube cavity 15, and the two balloons are injected and pressurized through the first injection port 16 and the second injection port 17 respectively. The pressurization is completely independent, with strong controllability and easy positioning, which greatly shortens the operation time.

[0051] As a preferred embodiment, a plurality of pressure-filling and pressure-releasing ports 18 are evenly opened in the middle of the outer wall of the inner tube 14 included in the pre-dilation balloon 2 .

[0052] As a preferred embodiment, the drug composition layer 6 includes at least one of paclitaxel and rapamycin, and an optional drug carrier.

[0053] Here, the outer walls of the restraining ring 8 and the drug balloon 3 are coated with a drug coating.

[0054] As a preferred embodiment, the distance between the marking ring 9 and the end of the drug balloon 3 is 5-6 mm, the material of the marking ring 9 is any one of gold, platinum, nickel-titanium alloy, and silicone doped with bright color masterbatch, the material of the restraint ring 8 is high-strength fiber or nickel-titanium alloy, and the elastic tip 5 is made of silicone.

[0055] Here, the material of the restraining ring 8 can be high-strength fiber such as ultra-high density polyethylene or a nickel-titanium alloy ring, and the surface is coated with a water-soluble drug coating for treating prostate hyperplasia such as paclitaxel.

[0056] As a preferred embodiment, the pre-dilation balloon 2 is a compliant balloon, and the drug balloon 3 is a non-compliant balloon or a low-compliant balloon.

[0057] Here, the pre-dilation balloon 2 is set as a compliant balloon to ensure that the expansion process of the pre-dilation balloon will not damage the prostate, and the drug balloon 3 is set as a non-compliant balloon or a low-compliance balloon to ensure that the drug balloon 3 has better dimensional stability after expansion, and can better expand the urethra 20 so that the drug on the surface of the drug balloon 3 is in full contact with the inner side of the urethra.

[0058] Here, the drug balloon 3 catheter 1 enters the narrow lesion of the prostatic hyperplasia urethra 20 through a delivery system such as a cystoscope 19, the elastic tip and the pre-expansion balloon 2 enter the bladder 19, and the balloon neck is located at the neck of the bladder 19. During the process, the marking ring 9 is used to confirm whether the balloon assembly has reached the predetermined position. The pre-expansion balloon 2 is first filled through the second injection port 17 to anchor the drug balloon 3 catheter 1 at the neck of the bladder 19, and then the drug balloon 3 is filled through the first injection port 16 and injected with physiological saline to expand into a gourd shape, which plays a role in expansion and drug release. The neck of the drug balloon 3 is anchored at the neck of the bladder 19 to prevent the drug balloon 3 from slipping. The narrow part of the prostatic urethra 20 is expanded by the drug balloon 3, causing the prostatic capsule to split, and the prostatic tissue of the proliferated lobes on both sides is pushed outward to form a "tissue pad", which relieves the pressure of the prostatic hyperplasia on the urethra 20. The scoring wire scores the prostatic urethra 20 to form orderly microcracks. The water-soluble drug coating on the drug balloon 3 and the balloon neck surface more effectively penetrates into the prostate hyperplasia tissue through the microcracks of the urethra 20, exerts a therapeutic effect, and prevents the prostate hyperplasia from compressing the urethra 20 again.

[0059] Here, the proximal end usually refers to the end of the medical device that is close 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 away from the operator.

[0060] The above are only preferred embodiments of the present invention and are not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A drug balloon catheter for treating benign prostatic hyperplasia, characterized in that: The invention comprises a catheter (1), a pre-dilation balloon (2) and a drug balloon (3) connected to the end of the pre-dilation balloon (2), wherein the two ends of the catheter (1) are respectively connected to a Y-shaped needle seat (4) and an elastic tip (5), the pre-dilation balloon (2) and the drug balloon (3) are sequentially fixedly connected to a side of the catheter (1) close to the elastic tip (5), the outer surface of the drug balloon (3) is coated with a drug composition layer (6), and the outer surface of the drug balloon (3) is provided with a scoring component (7); The scoring assembly (7) comprises a scoring piece, a restraining ring (8) and a marking ring (9); the scoring piece is fixedly connected to the outside of the drug balloon (3); the restraining ring (8) is sleeved at the connection between the pre-expansion balloon (2) and the drug balloon (3); the marking ring (9) is fixedly connected to the catheter (1) at the proximal end of the drug balloon (3); and the two ends of the scoring piece are fixedly connected to the restraining ring (8) and the marking ring (9) respectively.

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

3. A drug balloon catheter for treating benign prostatic hyperplasia according to claim 1, characterized in that: The scoring member comprises 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) being respectively connected to the restraining ring (8) and the marking ring (9), the plurality of second scoring wires (11) being equidistantly arranged on the outer surface of the drug balloon (3), the material of the second scoring wires (11) being shape memory alloy or hard fiber, and the second scoring wires (11) being triangular wires or round flat wires.

4. A drug balloon catheter for treating benign prostatic hyperplasia according to claim 1, characterized in that: The proximal end of the pre-dilation balloon (2) is integrally connected with a bonding platform (12), and the bonding platform (12) is connected to the outside of the catheter (1). The distal end of the drug balloon (3) is bonded to the outside of the bonding platform (12), and the bonding platform (12) is 1-3 mm along the length of the catheter (1).

5. The drug balloon catheter for treating benign prostatic hyperplasia according to claim 1, characterized in that: The catheter (1) comprises an outer tube (13) and an inner tube (14) inserted into the inner cavity 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 balloon (3) is connected to the outer tube lumen (15); the pre-dilation balloon (2) is connected to the inner tube (14); the outer tube lumen (15) is not connected to the inner tube (14).

6. A drug balloon catheter for treating benign prostatic hyperplasia according to claim 5, characterized in that: The Y-shaped needle seat (4) comprises a first injection port (16) and a second injection port (17) which are 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).

7. A drug balloon catheter for treating benign prostatic hyperplasia according to claim 5, characterized in that: A plurality of pressure-inflating and pressure-releasing ports (18) are evenly arranged in the middle of the outer wall of the inner tube (14) contained within the pre-expansion balloon (2).

8. The drug balloon catheter for treating benign prostatic hyperplasia according to claim 1, characterized in that: The drug composition layer (6) comprises at least one of paclitaxel and rapamycin, and an optional drug carrier.

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

10. The drug balloon catheter for treating benign prostatic hyperplasia according to claim 1, characterized in that: The pre-dilation balloon (2) is a compliant balloon, and the drug balloon (3) is a non-compliant balloon or a low-compliant balloon.

Images