Drug balloon catheter for treating benign prostatic hyperplasia

Abstract

The utility model discloses a medicine balloon catheter for treating benign prostatic hyperplasia, which belongs to the technical field of medical instruments and comprises a catheter, a pre-expansion balloon and a medicine balloon, two ends of the catheter are respectively connected with a Y-shaped needle seat and an elastic tip, and the pre-expansion balloon and the medicine balloon are sequentially connected onto the catheter. The near end of the pre-dilation balloon is integrally connected with a bonding platform, the far end of the medicine balloon is fixedly connected to the outer side of the bonding platform to form a balloon neck, the outer side of the balloon neck is sleeved with a restraint ring, the catheter is provided with a marking ring at the near end of the medicine balloon, and the outer surface of the medicine balloon is coated with a medicine composition layer; the bonding platform is in an inverted cone shape, a bonding ring table extends from the connecting position of the bonding platform and the pre-dilation balloon, and the medicine balloon is connected with the bonding ring table. The pre-expansion balloon and the medicine balloon can be expanded respectively through the bonding platform, and the nick wires expand the prostatic urethra in order to form micro-cracks, so that the absorption efficiency of the medicine coating is improved.

Description

Technical Field

[0001] This utility model 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 can 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 treatments 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 balloon used in TUCBDP is difficult to control in terms of expansion because there are no limiting devices on the positioning and outer sides of the balloon. Due to the folds in the prostatic urethra, the medication on the balloon surface is only applied to a portion of the tissue, resulting in poor long-term efficacy and slow therapeutic effect in inhibiting BPH. Furthermore, there is a risk of the catheter slipping during balloon positioning and expansion.

[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 hospital stays, significant bleeding, and a series of intraoperative 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. Utility Model Content

[0006] To overcome the problems of poor treatment effect, slow efficacy, time-consuming positioning, and inaccurate balloon expansion in existing drug-eluting balloons due to the accumulation of medication on the balloon surface in the folds of the prostate, this invention provides a drug-eluting balloon catheter for the treatment of benign prostatic hyperplasia, comprising a catheter, a pre-dilation balloon, and a drug-eluting balloon. The catheter has a Y-shaped needle hub and an elastic tip at both ends. The pre-dilation balloon and the drug-eluting balloon are sequentially connected to the side of the catheter near the elastic tip. An adhesive platform is integrally connected to the proximal end of the pre-dilation balloon. One end of the drug-eluting balloon is fixedly connected to the outside of the adhesive platform to form the balloon neck. A restraint ring is fitted outside the balloon neck. A marking ring is provided at the proximal end of the catheter for the drug-eluting balloon, and the marking ring is fixedly connected to the outer wall of the catheter. A drug composition layer is coated on the outer surface of the drug-eluting balloon.

[0007] The bonding platform is inverted conical in shape, and an bonding ring extends from the bonding platform at the connection point with the pre-dilated balloon. The drug-eluting balloon is fixedly connected to the bonding ring.

[0008] By using a pre-dilatation balloon and a drug-eluting balloon in a combined configuration, the balloon catheter can be effectively anchored to prevent balloon displacement and subsequent prostate damage during dilation. A restraint ring at the balloon neck further controls the dilation size, preventing excessive dilation that could damage the bladder neck. An adhesive platform securely connects the pre-dilatation balloon and the drug-eluting balloon, allowing them to dilate independently for treatment. This design limits the balloon dilation to prevent urethral damage and allows the drug-eluting balloon to expand more effectively, ensuring greater absorption of the medication and improving treatment efficacy.

[0009] In a preferred embodiment, a first scoring wire is provided on the outer surface of the drug-eluting balloon. The first scoring wire is spirally wound and fixed to the outer surface of the drug-eluting balloon. 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 scoring wire is a triangular wire or a round flat wire.

[0010] In a preferred embodiment, the outer surface of the drug-eluting balloon is provided with a plurality of second scoring wires, the two ends of which 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-eluting 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] The above technical solution uses a scoring wire to expand the prostatic urethra into orderly microfissures without damaging the urethra. The drug composition layer on the surface of the drug balloon and the balloon neck is absorbed through the microfissures in the urethra, allowing it to penetrate more effectively into the prostatic hyperplasia tissue, exert a therapeutic effect, and prevent prostatic restenosis. At the same time, the scoring wire also plays a certain role in preventing slippage.

[0012] In a preferred embodiment, 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.

[0013] In a preferred embodiment, the Y-shaped needle hub includes a first injection port and a second injection port integrally connected to the catheter, wherein the first injection port communicates with the outer tube cavity and the second injection port communicates with the inner tube.

[0014] In a preferred embodiment, a plurality of inflation / deflation ports are uniformly provided in the middle of the outer wall of the inner tube encompassing the pre-expanded balloon.

[0015] In a preferred embodiment, the bonding platform is 1-3 mm long along the conduit.

[0016] In a preferred embodiment, the distance between the marking ring and the end of the drug capsule is 5-6 mm, and the marking ring is made of any one of silicone, gold, platinum, or nickel-titanium alloy doped with bright color masterbatch.

[0017] In a preferred embodiment, the pharmaceutical composition layer includes at least one of paclitaxel and rapamycin, and optionally a pharmaceutical carrier.

[0018] In a preferred embodiment, the constraint ring is made of high-strength fiber or nickel-titanium alloy, and the elastic tip is made of silicone.

[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.

[0020] Beneficial effects:

[0021] The beneficial effects of adopting the technical solution of this utility model are as follows:

[0022] (1) By splicing the pre-dilation balloon and the drug-eluting 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-eluting balloon are firmly connected by an adhesive platform, and the two balloons can be dilated independently for treatment. By setting the scoring wire on the surface of the drug-eluting balloon, micro-cracks are formed in the prostatic urethra during the dilation of the drug-eluting balloon, which increases the contact area of ​​the drug with the tissue and improves 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.

[0023] (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.

[0024] (3) During treatment, the surgery can be completed simply by contacting and expanding the pre-dilatation balloon in the balloon assembly with the prostatic urethra wrapped in the prostate. The treatment process is simple and safe. The pre-dilatation 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, highly controllable, easy to locate, and greatly shortens the operation time. Attached Figure Description

[0025] To more clearly illustrate the technical solutions of the embodiments of this utility model, the drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this utility model 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.

[0026] 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 this utility model;

[0027] 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 this utility model;

[0028] 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 this utility model;

[0029] 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 this utility model;

[0030] Figure 5 This is a schematic diagram showing the position of the second notched wire in a drug-eluting balloon catheter for the treatment of benign prostatic hyperplasia according to this utility model.

[0031] 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 this utility model;

[0032] Figure 7 This is a schematic diagram of the unpressurized state of a drug balloon catheter for the treatment of benign prostatic hyperplasia according to this utility model.

[0033] 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 this utility model;

[0034] Figure 9 This invention relates to a triangular wire of a drug balloon catheter for the treatment of benign prostatic hyperplasia.

[0035] 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 this utility model.

[0036] In the diagram, 1. Catheter; 2. Pre-dilatation balloon; 3. Drug-eluting balloon; 4. Y-shaped needle hub; 5. Elastic tip; 6. Adhesion platform; 7. Balloon neck; 8. Restraint ring; 9. Marking ring; 10. Drug composition layer; 11. Adhesion ring platform; 12. First notch wire; 13. Second notch wire; 14. Outer tube; 15. Inner tube; 16. Outer tube lumen; 17. First injection port; 18. Second injection port; 19. Inflation / depression port; 20. Urethra; 21. Bladder. Detailed Implementation

[0037] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions of the embodiments of this utility model 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 this utility model, not all of them. Therefore, the following detailed description of the embodiments of this utility model provided in the accompanying drawings is not intended to limit the scope of the claimed utility model, but merely to represent selected embodiments of this utility model. All other embodiments obtained by those skilled in the art based on the embodiments of this utility model without inventive effort are within the scope of protection of this utility model.

[0038] 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:

[0039] like Figure 1-10As shown, a drug-eluting balloon catheter 1 for treating benign prostatic hyperplasia includes a catheter 1, a pre-dilation balloon 2, and a drug-eluting balloon 3. Y-shaped needle hubs 4 and elastic tips 5 are connected to both ends of the catheter 1. The pre-dilation balloon 2 and the drug-eluting balloon 3 are sequentially connected to the side of the catheter 1 near the elastic tip 5. An adhesive platform 6 is integrally connected to the proximal end of the pre-dilation balloon 2. The distal end of the drug-eluting balloon 3 is fixedly connected to the outside of the adhesive platform 6 to form a balloon neck 7. The outer layer is part of the drug-eluting balloon 3, and the inner layer is part of the pre-dilation balloon 2. The connection between the two forms the balloon neck 7. A restraint ring 8 is sleeved on the outside of the balloon neck 7. A marking ring 9 is provided at the proximal end of the drug-eluting balloon 3 in the catheter 1. The marking ring 9 is fixedly connected to the outer wall of the catheter 1. A drug composition layer 10 is coated on the outer surface of the drug-eluting balloon 3.

[0040] The bonding platform 6 is inverted cone-shaped, and an bonding ring 11 extends from the connection between the bonding platform 6 and the pre-expanded balloon 2. The drug-eluting balloon 3 is fixedly connected to the bonding ring 11.

[0041] Here, the pre-dilatation balloon 2 and the drug-eluting balloon 3 are spliced ​​together, which can effectively 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 7 to better restrain the dilation size of the balloon neck 7 and prevent excessive dilation of the balloon neck 7 from damaging the neck of the bladder 21. The outer surface of the drug-eluting balloon 3 is provided with a notching component for cutting the narrow position of the urethra 20. The pre-dilatation balloon 2 and the drug-eluting balloon 3 are firmly connected by the bonding platform 6. The two balloons can be dilated independently for treatment, while limiting the extent of balloon dilation to prevent damage to the urethra 20.

[0042] 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.

[0043] In a preferred embodiment, a first scoring wire 12 is provided on the outer surface of the drug-eluting balloon 3. The first scoring wire 12 is spirally wound and fixed on the outer surface of the drug-eluting balloon 3. The two ends of the first scoring wire 12 are connected to the constraint ring 8 and the marking ring 9, respectively. The material of the first scoring wire 12 is shape memory alloy or hard fiber, and the scoring wire is a triangular wire or a round flat wire.

[0044] In a preferred embodiment, the outer surface of the drug-eluting balloon 3 is provided with a plurality of second scoring wires 13. The two ends of the second scoring wires 13 are connected to the constraint ring 8 and the marking ring 9, respectively. The plurality of second scoring wires 13 are equidistantly arranged on the outer surface of the drug-eluting balloon 3. The material of the second scoring wires 13 is shape memory alloy or hard fiber. The second scoring wires 13 are triangular wires or round flat wires.

[0045] Here, the scoring wire expands the prostatic urethra 20 to form orderly microfissures without damaging the urethra 20. The drug composition layer 10 on the surface of the drug balloon 3 and the balloon neck 7 is absorbed through the microfissures of the urethra 20, penetrating more effectively into the prostatic hyperplasia tissue to exert a therapeutic effect. At the same time, the scoring wire also plays a certain role in preventing slippage.

[0046] In a preferred embodiment, the catheter 1 includes an outer tube 14 and an inner tube 15 that passes through the inner lumen of the outer tube 14. An outer tube cavity 16 is formed between the outer wall of the inner tube 15 and the inner wall of the outer tube 14. The drug-eluting balloon 3 communicates with the outer tube cavity 16, and the pre-dilation balloon 2 communicates with the inner tube 15. The outer tube cavity 16 is not communicated with the inner tube 15. The proximal end of the drug-eluting balloon 3 is connected to the outer wall of the outer tube 14, and the distal end of the pre-dilation balloon 2 is connected to the outside of the inner tube 15.

[0047] In a preferred embodiment, the Y-type needle hub 4 includes a first injection port 17 and a second injection port 18 integrally connected to the catheter 1. The first injection port 17 is connected to the outer tube cavity 16, and the second injection port 18 is connected to the inner tube 15.

[0048] 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 balloon 3 are connected separately to the inner tube 15 and the outer tube 16. The two balloons are pressurized by injection through the first injection port 17 and the second injection port 18. The pressurization is carried out completely independently, which is highly controllable, easy to locate, and greatly shortens the operation time.

[0049] In a preferred embodiment, a plurality of inflation / deflation ports 19 are evenly provided in the middle of the outer wall of the inner tube 15 encompassing the pre-expanded balloon 2.

[0050] In a preferred embodiment, the bonding platform 6 is 1-3 mm long along the conduit 1.

[0051] In a preferred embodiment, the distance between the marking ring 9 and the end of the drug capsule 3 is 5-6 mm, and the marking ring 9 is made of any one of silicone, gold, platinum, or nickel-titanium alloy doped with bright color masterbatch.

[0052] In a preferred embodiment, the pharmaceutical composition layer 10 includes at least one of paclitaxel and rapamycin, and optionally a pharmaceutical carrier.

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

[0054] In a preferred embodiment, the constraint ring 8 is made of high-strength fiber or nickel-titanium alloy, and the elastic tip 5 is made of silicone.

[0055] 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.

[0056] Here, the drug-eluting balloon 3, via catheter 1, is delivered to the stenotic lesion of the prostatic hyperplasia urethra 20 through a delivery system such as a cystoscope 21. The elastic tip 5 and the pre-dilatation balloon 2 are inserted into the bladder 21, with the balloon neck 7 positioned at the neck of the bladder 21. During the process, a marker ring 9 is used to confirm that the balloon assembly has reached the predetermined position. First, the pre-dilatation balloon 2 is inflated through the second injection port 18 to anchor the drug-eluting balloon 3, via catheter 1, at the neck of the bladder 21. Then, the drug-eluting balloon 3 is inflated through the first injection port 17, injecting physiological saline to expand it into a gourd-like shape, serving to dilate and release the drug. The neck of the drug-eluting balloon 3 is anchored at the neck of the bladder 21 to prevent it from slipping. 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 balloon 3 and balloon neck 7 can penetrate more effectively into the prostatic hyperplasia tissue through the micro-cracks in the urethra 20, exert a therapeutic effect, and prevent the prostatic hyperplasia from compressing the urethra 20 again.

[0057] 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.

[0058] The above are merely preferred embodiments of this utility model and are not intended to limit the scope of this utility model. Various modifications and variations can be made to this utility model by those skilled in the art. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of this utility model should be included within the protection scope of this utility model.

Claims

1. A drug balloon catheter for the treatment of benign prostatic hyperplasia, characterized in that, The application relates to a drug balloon catheter, which comprises a catheter (1), a pre-dilation balloon (2) and a drug balloon (3), the two ends of the catheter (1) are respectively connected with a Y-shaped needle seat (4) and an elastic tip (5), the pre-dilation balloon (2) and the drug balloon (3) are sequentially connected to one side of the catheter (1) close to the elastic tip (5), the proximal end of the pre-dilation balloon (2) is integrally connected with a bonding platform (6), the distal end of the drug balloon (3) is fixedly connected to the outer side of the bonding platform (6) to form a balloon neck (7), the outer side of the balloon neck (7) is sleeved with a constraint ring (8), the catheter (1) is provided with a mark ring (9) at the proximal end of the drug balloon (3), the mark ring (9) is fixedly connected with the outer wall of the catheter (1), and the outer surface of the drug balloon (3) is coated with a drug composition layer (10). The bonding platform (6) is inverted conical, the bonding platform (6) is extended with a bonding ring table (11) at the connecting position with the pre-dilation balloon (2), and the drug balloon (3) is fixedly connected with the bonding ring table (11).

2. The drug balloon catheter for the treatment of benign prostatic hyperplasia according to claim 1, wherein, The outer surface of the drug balloon (3) is provided with a first notch wire (12), the first notch wire (12) is spirally fixed on the outer surface of the drug balloon (3), the two ends of the first notch wire (12) are respectively connected with the constraint ring (8) and the mark ring (9), the material of the first notch wire (12) is shape memory alloy or hard fiber, and the notch wire is a triangular wire or a round flat wire.

3. The drug balloon catheter for the treatment of benign prostatic hyperplasia according to claim 1, wherein, The outer surface of the drug balloon (3) is provided with a plurality of second notch wires (13) for cutting the narrow position of a urethra (20), the two ends of the second notch wire (13) are respectively connected with the constraint ring (8) and the mark ring (9), the plurality of second notch wires (13) are equidistantly arranged on the outer surface of the drug balloon (3), the material of the second notch wire (13) is shape memory alloy or hard fiber, and the second notch wire (13) is a triangular wire or a round flat wire.

4. The drug balloon catheter for the treatment of benign prostatic hyperplasia according to claim 1, wherein, The catheter (1) comprises an outer tube (14) and an inner tube (15) arranged in the inner cavity of the outer tube (14), an outer tube cavity (16) is formed between the outer wall of the inner tube (15) and the inner wall of the outer tube (14), the drug balloon (3) communicates with the outer tube cavity (16), the pre-dilation balloon (2) communicates with the inner tube (15), and the outer tube cavity (16) does not communicate with the inner tube (15).

5. The drug balloon catheter for the treatment of benign prostatic hyperplasia according to claim 4, characterized in that, The Y-shaped needle seat (4) comprises a first injection port (17) and a second injection port (18) integrally connected with the catheter (1), the first injection port (17) communicates with the outer tube cavity (16), and the second injection port (18) communicates with the inner tube (15).

6. The drug balloon catheter for the treatment of benign prostatic hyperplasia according to claim 4, wherein, A plurality of pressure charging and discharging ports (19) are uniformly arranged in the middle part of the outer wall of the inner tube (15) in the pre-dilation balloon (2).

7. The drug balloon catheter for the treatment of benign prostatic hyperplasia according to claim 1, wherein, The distance between the bonding platform (6) and the catheter (1) is 1-3 mm.

8. The drug balloon catheter for the treatment of benign prostatic hyperplasia according to claim 1, wherein, The distance between the marker ring (9) and the end of the drug balloon (3) is 5-6 mm, and the material of the marker ring (9) is any one of doped bright color mother silica gel, gold, platinum, nickel-titanium alloy.

9. The drug balloon catheter for the treatment of benign prostatic hyperplasia according to claim 1, wherein, The drug composition layer (10) comprises at least one of paclitaxel and rapamycin, and optionally a drug carrier.

10. The drug balloon catheter for the treatment of benign prostatic hyperplasia according to claim 1, wherein, The material of the constraint ring (8) is high-strength fiber or nickel-titanium alloy, and the elastic tip (5) is silica gel.

Images