Urethral catheter with medicine carrying balloon
By designing a catheter with a drug-loading balloon, using the braided net to release drugs and positioning functions, the safety and effectiveness issues in the treatment of prostate hyperplasia are solved, and the precise release and efficient expansion of the drug are achieved, and the risk of side effects and complications is reduced.
Patent Information
- Application Number
- CN202410105256.2
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-01-24
- Publication Date
- 2025-07-25
AI Technical Summary
In the prior art, drug treatment for prostate hyperplasia has great side effects, surgical trauma and many complications, and there is a lack of safe and efficient treatment methods.
A catheter with a drug-loading balloon is designed. The outer surface of the drug-loading balloon is wrapped with a braided net, and the drugs are released through the braided net, combined with the expansion and contraction functions of the positioning part to achieve accurate treatment of the prostate.
It achieves accurate release of drugs, reduces side effects, is safer than surgical procedures, and can better maintain shape, reduce the risk of sliding and shedding, provide higher blasting pressure, and expand the prostate urethra.
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Figure CN120361394A_ABST
Abstract
Description
Technical Field
[0001] The invention relates to the technical field of medical devices, in particular to a urinary catheter with a drug-loaded balloon. Background Art
[0002] Prostatic hyperplasia is a very common phenomenon among elderly men. About 40%-50% of men over 50 years old have prostatic hyperplasia, and about 90% of men over 80 years old have prostatic hyperplasia. At present, the most mainstream treatment for prostatic hyperplasia in China is through drug treatment, which is mainly divided into two types: one is a drug used to reduce the size of the patient's prostate, and the other is a drug used to relieve the tension of the male urethral smooth muscle. Usually, these two drugs are required for combined treatment. This is because it takes a long time for the first type of drug to reduce the size of the prostate and relieve symptoms, so it is necessary to take the second type of drug at the same time to quickly help patients relieve urination difficulties. In addition, the drug must be taken for a long time. Once the drug is stopped, lower urinary tract symptoms such as dysuria will worsen.
[0003] In order to solve the side effects of oral medication, some patients will use surgical treatment, such as traditional surgery, namely transurethral resection of the prostate, which uses heat energy to cut off the hyperplastic prostate tissue. However, this method of surgery causes large amounts of bleeding, many complications, and slow patient recovery. Laser therapy is also used to treat prostate hyperplasia, but both laser therapy and transurethral resection are invasive surgeries that can easily damage important structures near the prostate tissue. Therefore, they may also cause more postoperative complications, such as retrograde ejaculation, urethral stenosis, sexual dysfunction, urinary incontinence, etc. Summary of the invention
[0004] Based on this, there is a need to provide a urinary catheter with a drug-loaded balloon, which can treat prostate hyperplasia and replace existing oral medications or surgical operations.
[0005] A urinary catheter with a drug-loaded balloon, the urinary catheter with a drug-loaded balloon comprising:
[0006] The tube body has a urinary catheterization channel and a filling channel which are independent of each other;
[0007] A drug-loaded balloon is disposed at the distal end of the tube body, the drug-loaded balloon is communicated with the filling channel, and a drug-loaded structure is disposed on the outer surface of the drug-loaded balloon;
[0008] A woven mesh is wrapped around the periphery of the drug-loaded balloon, and the drug in the drug-loaded structure is released from the mesh openings of the woven mesh.
[0009] In one embodiment, the catheter with a drug - loaded balloon further includes a positioning part, which is arranged at the distal end of the tube body and is spaced from the distal end of the drug - loaded balloon; there is a cavity inside the positioning part, and the cavity is communicated with the urine drainage channel. There are urine drainage openings communicated with the cavity arranged circumferentially on the positioning part. The positioning part has an expanded state and a contracted state, and the expanded outer diameter of the positioning part in the expanded state is larger than the contracted outer diameter in the contracted state.
[0010] In one embodiment, the positioning part is made of an elastic material.
[0011] In one embodiment, the positioning part includes a plurality of positioning strips arranged circumferentially along the tube body. The proximal ends of each positioning strip are connected to the tube body, the distal ends of each positioning strip are connected, and urine drainage openings are formed between adjacent positioning strips.
[0012] In one embodiment, the distal end of the positioning part has a guiding tube section. The guiding tube section has a guiding tube cavity for a guide wire to extend into. The proximal end of the guiding tube cavity is communicated with the cavity, and the distal end of the guiding tube section is a closed end.
[0013] In one embodiment, the drug - loaded balloon includes a straight section and two tapered sections. The two tapered sections are respectively connected to the proximal end and the distal end of the straight section; the angle between the generatrix of the tapered section connected to the proximal end of the straight section and the central axis is greater than or equal to 30° and less than or equal to 45°; the outer diameter of the straight section is greater than or equal to 25 mm and less than or equal to 40 mm.
[0014] In one embodiment, the length of a single mesh opening of the braided mesh is greater than or equal to 0.1 mm and less than or equal to 0.5 mm; the width of a single mesh opening of the braided mesh is greater than or equal to 0.1 mm and less than or equal to 0.5 mm.
[0015] In one embodiment, the drug - loading structure is a drug coating or drug - loaded microneedles. The drugs in the drug - loading structure include: paclitaxel and its derivatives, or rapamycin and its derivatives.
[0016] In one embodiment, the tube body includes an outer tube, an inner tube, and a filling tube. The inner tube and the filling tube are arranged inside the outer tube. The lumen of the inner tube is the urine drainage channel, and the lumen of the filling tube is the filling channel;
[0017] The distal ends of the inner tube and the filling tube extend out of the outer tube and are located inside the drug - loaded balloon; the part of the filling tube located inside the drug - loaded balloon is provided with filling holes;
[0018] The inner tube and the filling tube are two of the cavities of a multi - lumen tube, or the inner tube and the filling tube are independent tubes.
[0019] In one embodiment, the catheter with a drug-loaded balloon further includes a connection joint connected to the proximal end of the tube body. The connection joint includes a urine drainage joint and a filling joint connected to each other. The urine drainage joint communicates with the proximal end of the urine drainage channel, and the filling joint communicates with the proximal end of the filling channel. A one-way valve is provided in the filling joint or the filling channel.
[0020] In one embodiment, the woven mesh is a fiber woven mesh; the woven mesh is woven on the surface of the drug-loaded balloon by fiber filaments, or the woven mesh is first woven into a net shape by fiber filaments and then attached to the surface of the drug-loaded balloon.
[0021] When the above-mentioned catheter with a drug-loaded balloon is used for treating benign prostatic hyperplasia, it is inserted into the urethra of the human body so that the drug-loaded balloon is located at the prostate site. Liquid is filled into the drug-loaded balloon through the filling channel, so that the drug-loaded balloon expands and closely adheres to the prostate site. Then, the drug in the drug-loading structure on the outer surface of the drug-loaded balloon can be released from the mesh openings of the woven mesh, and the drug slowly diffuses through the mesh openings and penetrates deep into the prostate, achieving the effect of treating benign prostatic hyperplasia. Compared with traditional oral drug treatment, it has fewer side effects and is safer than surgical operations. In addition, traditional catheters use a common silicone balloon structure for positioning, placing the common silicone balloon in the bladder to position the catheter. However, the burst pressure of this catheter is relatively low, and it is only used as a positioning part placed in the bladder. The catheter of the present application uses a drug-loaded balloon wrapped with a woven mesh, so that the catheter can obtain a higher burst pressure, and then the prostate urethra of the patient can be more fully dilated through the drug-loaded balloon; at the same time, the presence of the woven mesh enables the drug-loaded balloon to have better shape-holding ability, so that the drug-loaded balloon is not easily deformed under the compression of the prostate. Urine in the bladder can be discharged through the urine drainage channel.
[0022] In addition, during the expansion of the drug-loaded balloon, the woven mesh will also contact the prostate site. Due to the mesh structure characteristics of the woven mesh, the risk of the drug-loaded balloon sliding and shifting during expansion can be reduced, which is beneficial to accurately releasing the drug at the prostate site. After the drug-loaded balloon is fully expanded, due to the elasticity of the prostate urethra, the woven mesh will partially sink into the prostate, increasing the friction with the prostate site and reducing the risk of the catheter sliding and falling off. BRIEF DESCRIPTION OF THE DRAWINGS
[0023] Figure 1 It is a schematic structural diagram of a catheter with a drug-loaded balloon according to an embodiment.
[0024] Figure 2 is Figure 1 A schematic diagram of the catheter with a drug-loaded balloon shown in the delivery state.
[0025] Figure 3 The Figure 1 longitudinal sectional view schematic diagram of the catheter with a drug-loaded balloon shown in the figure.
[0026] Figure 4 The Figure 3 local enlarged view of area A in the figure.
[0027] Figure 5 structural schematic diagram of the braided mesh of an embodiment.
[0028] Figure 6 The
[0029] Schematic diagram of the results of the balloon burst pressure measured for 15 catheters each of a catheter with a drug-loaded balloon wrapped with a braided mesh and a traditional catheter with an ordinary silicone balloon without a wrapped braided mesh in an embodiment of the present application under 37 °C water.
[0030] Reference numeral description:
[0031] 100, tube body; 110, outer tube; 120, inner tube; 130, filling tube; 131, filling hole;
[0032] 200, drug-loaded balloon; 210, straight section; 220, first tapered section; 220, second tapered section;
[0033] 300, braided mesh; 310, mesh opening;
[0034] 400, positioning part; 410, urine drainage opening; 420, positioning strip; 430, guiding tube section; 431, guiding tube lumen;
[0035] In order to make the above objects, features and advantages of the present invention more obvious and understandable, the following will describe in detail the specific embodiments of the present invention with reference to the accompanying drawings. Many specific details are set forth in the following description in order to fully understand the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the connotation of the present invention. Therefore, the present invention is not limited by the specific embodiments disclosed below.
[0036] In the description of the present invention, it should be understood that the orientation or positional relationship indicated by terms such as "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. is based on the orientation or positional relationship shown in the drawings. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, it should not be construed as a limitation to the present invention.
[0037] In addition, the terms "first" and "second" are only used for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, the features defined with "first" and "second" may explicitly or implicitly include at least one of such features. In the description of the present invention, the meaning of "a plurality of" is at least two, such as two, three, etc., unless otherwise specifically and clearly defined.
[0038] In the present invention, unless otherwise clearly specified and defined, terms such as "mounted", "connected", "joined", "fixed", etc. shall be understood in a broad sense. For example, it may be a fixed connection, a detachable connection, or integrated; it may be a mechanical connection or an electrical connection; it may be directly connected or indirectly connected through an intermediate medium, and it may be the internal communication of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.
[0039] In the present invention, unless otherwise clearly specified and defined, the first feature being "on" or "under" the second feature may be that the first and second features are in direct contact, or the first and second features are indirectly in contact through an intermediate medium. Moreover, the first feature being "above", "over" and "on top of" the second feature may be that the first feature is directly above or obliquely above the second feature, or merely indicates that the first feature has a higher horizontal height than the second feature. The first feature being "under", "beneath" and "underneath" the second feature may be that the first feature is directly below or obliquely below the second feature, or merely indicates that the first feature has a lower horizontal height than the second feature.
[0040] It should be noted that when an element is referred to as "fixed to" or "disposed on" another element, it can be directly on the other element or there may also be an intermediate element. When an element is considered to be "connected" to another element, it can be directly connected to the other element or there may be an intermediate element at the same time. The terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used herein are for illustrative purposes only and do not represent the only implementation.
[0041] In the embodiments of the present application, the terms "distal end" and "proximal end" are used. Among them, the proximal end is the end of each component of the catheter with a drug-loaded balloon close to the operator, and the distal end refers to the other end opposite to the proximal end.
[0042] Please refer to Figures 1 to 4 , an embodiment of the present application provides a catheter with a drug-loaded balloon. The catheter with a drug-loaded balloon includes: a tube body 100, a drug-loaded balloon 200 and a braided mesh 300. The tube body 100 has an independent urine drainage channel and a filling channel. The drug-loaded balloon 200 is disposed at the distal end of the tube body 100, and the drug-loaded balloon 200 is communicated with the filling channel. A drug-loading structure (not shown) is provided on the outer surface of the drug-loaded balloon 200. The braided mesh 300 is wrapped around the periphery of the drug-loaded balloon 200. Refer to Figure 5 , the drug in the drug-loading structure can be released from the mesh openings 310 of the braided mesh 300.
[0043] When the above-mentioned catheter with a drug-loaded balloon is used for the treatment of benign prostatic hyperplasia, it is inserted into the urethra of the human body so that the drug-loaded balloon 200 is located at the prostate site. Liquid is filled into the drug-loaded balloon 200 through the filling channel, so that the drug-loaded balloon 200 expands and closely adheres to the prostate site. Furthermore, the drug in the drug-loading structure on the outer surface of the drug-loaded balloon 200 can be released from the mesh openings 310 of the braided mesh 300. The drug slowly diffuses through the mesh openings 310 and penetrates deep into the prostate, and can achieve the effect of treating benign prostatic hyperplasia. Compared with the traditional oral drug treatment, it has a more accurate curative effect, and is safer compared with surgical operations. Since the braided mesh 300 is wrapped around the periphery of the drug-loaded balloon 200, the drug-loaded balloon 200 can obtain a higher burst pressure, and thus the prostatic urethra of the patient can be more fully dilated. In this way, the catheter with a drug-loaded balloon 200 can be used for the treatment of benign prostatic hyperplasia to achieve precise drug release; at the same time, the presence of the braided mesh 300 enables the drug-loaded balloon 200 to have a better ability to maintain its shape, so that the drug-loaded balloon 200 is not easily deformed under the compression of the prostate. Urine in the bladder can be discharged from the urine drainage channel.
[0044] The traditional catheter uses an ordinary silicone balloon for positioning in the bladder, but because its burst pressure is low, it cannot be used as an expansion structure for dilating the prostate. Figure 6Schematic diagram of the balloon burst pressure results measured for 15 catheters each, including the catheter with the drug-loaded balloon 200 wrapped with a braided mesh 300 and the traditional catheter with an ordinary silicone balloon not wrapped with a braided mesh, in the water at 37°C. The inventor obtained the research data shown through experimental tests using a balloon burst pressure tester. Figure 6 As shown by Figure 6 the figure, compared with the traditional catheter with an ordinary balloon not wrapped with a braided mesh, the catheter with the drug-loaded balloon 200 wrapped with a braided mesh 300 in the embodiment of the present application has a significantly higher burst pressure. Thus, it can be seen that the catheter of the present application can place the drug-loaded balloon 200 in the prostatic urethra to more fully dilate the patient's prostatic urethra, and then assist in the release of the drug on the drug-loaded balloon 200 to achieve precise treatment of benign prostatic hyperplasia.
[0045] In addition, during the expansion of the drug-loaded balloon 200, the braided mesh 300 also contacts the prostate part. Due to the mesh structure characteristics of the braided mesh 300, the risk of sliding and displacement of the drug-loaded balloon 200 during expansion can be reduced, which is beneficial to more accurately release the drug at the prostate part. After the drug-loaded balloon 200 is fully expanded, due to the elasticity of the prostatic urethra, the braided mesh 300 will partially sink into the prostate, increasing the friction with the prostate part and reducing the risk of catheter sliding and falling off.
[0046] The liquid filled in the drug-loaded balloon 200 can be normal saline or a 1:1 normal saline-contrast agent solution.
[0047] Please refer to Figures 1 to 3 In one embodiment, the catheter with a drug-loaded balloon further includes a positioning part 400. The positioning part 400 is provided at the distal end of the tube body 100 and is spaced from the distal end of the drug-loaded balloon 200. The positioning part 400 has a cavity inside, and the cavity is communicated with the urine drainage channel. The positioning part 400 is provided with urine drainage ports 410 communicating with the cavity in the circumferential direction. The positioning part 400 has a contracted state and an expanded state, and the outer diameter of the positioning part 400 in the expanded state (hereinafter referred to as the expanded outer diameter) is larger than its outer diameter in the contracted state (hereinafter referred to as the contracted outer diameter).
[0048] Specifically, the positioning part 400 can expand or contract and deform along the radial direction of the tube body 100, and the cavity inside the positioning part 400 provides space for its deformation along the radial direction of the tube body 100. By expanding or contracting and deforming along the radial direction of the tube body 100, the positioning part 400 can switch between the contracted state and the expanded state.
[0049] During the process of inserting the catheter with a drug - loaded balloon into the human urethra, the positioning part 400 is in a contracted state, and its contracted outer diameter is smaller (compared to the expanded outer diameter) to facilitate movement in the human urethra. The positioning part 400 is located on the side of the distal end of the drug - loaded balloon 200 facing away from the proximal end. Therefore, the positioning part 400 enters the human urethra earlier than the drug - loaded balloon 200. When the drug - loaded balloon 200 is at the prostate position, the positioning part 400 reaches the bladder orifice. At this time, the positioning part 400 can be switched to the expanded state, and its expanded outer diameter is larger (compared to the contracted outer diameter). Therefore, after the positioning part 400 expands, it can closely adhere to the bladder, so that the positioning part 400 is fixed at the bladder orifice, playing a role in positioning the entire catheter, and further ensuring that the position of the drug - loaded balloon 200 is stably at the prostate position.
[0050] Since the cavity is communicated with the urine drainage channel, and the urine drainage port 410 communicated with the cavity is provided on the circumferential direction of the positioning part 400. Therefore, when the positioning part 400 is fixed at the bladder orifice, the urine in the bladder can enter the cavity inside the positioning part 400 through the urine drainage port 410, and then flow into the urine drainage channel from the proximal end of the positioning part 400, and then the urine can be discharged.
[0051] Please refer to Figures 1 to 3 , in an embodiment, the positioning part 400 is made of an elastic material, such as a polymer material like silica gel. Since the positioning part 400 is made of an elastic material, it can expand or contract radially along the tube body 100 through elastic deformation, so as to switch between the contracted state and the expanded state.
[0052] During the process of inserting the catheter with a drug - loaded balloon into the human urethra, a guide wire can be passed through the urine drainage channel and extended into the positioning part 400, and the distal end of the guide wire is abutted against the distal end of the positioning part 400, so that the positioning part 400 receives an external force towards the distal end. Since the inside of the positioning part 400 is a cavity, when the distal end of the positioning part 400 receives an external force towards the distal end, the positioning part 400 can elongate axially along the tube body 100 towards the distal end and contract radially along the tube body 100, so that the positioning part 400 is in a contracted state to facilitate movement along the human urethra. When the positioning part 400 moves to the bladder orifice and the drug - loaded balloon 200 is at the prostate position, the guide wire can be withdrawn, so that the guide wire releases the distal end of the positioning part 400. Then, the positioning part 400 expands radially along the tube body 100 under the action of the elastic restoring force and switches to the expanded state, closely adhering to the bladder and then being fixed at the bladder orifice.
[0053] Combined with Figure 1 and Figure 3, in one embodiment, the positioning portion 400 includes a plurality of positioning strips 420 arranged circumferentially along the tube body 100. The proximal ends of the positioning strips 420 are all connected to the tube body 100, the distal ends of the positioning strips 420 are connected to each other, and urine guiding openings 410 are formed between adjacent positioning strips 420. Thus, when the positioning portion 400 is in an expanded state, each positioning strip 420 expands outwards, so that the positioning portion 400 can present a hollow spherical structure.
[0054] Since the plurality of positioning strips 420 are arranged circumferentially along the tube body 100 and urine guiding openings 410 are formed between adjacent positioning strips 420, when the positioning strips 420 are deformed, adjacent positioning strips 420 will not restrict and interfere with each other. Thus, when an external force towards the distal end from a guide wire acts on the distal end of the positioning portion 400, the plurality of positioning strips 420 are liable to elongate axially along the tube body 100 towards the distal end and contract radially along the tube body 100, so that it is very easy to switch from the expanded state to the contracted state, and the positioning portion 400 has a small radial dimension in the contracted state, thereby facilitating the movement of the positioning portion 400 in the human urethra.
[0055] In other embodiments, the positioning portion is not limited to including a plurality of positioning strips and may also be of other shapes.
[0056] Combined with Figures 1 to 3 , in one embodiment, the distal end of the positioning portion 400 has a guiding tube section 430. The guiding tube section 430 has a guiding tube cavity 431. The proximal end of the guiding tube cavity 431 communicates with the cavity of the positioning portion 400, and the distal end of the guiding tube section 430 is a closed end.
[0057] In this embodiment, the guide wire can pass through the urine guiding channel and extend into the positioning portion 400, and then pass through the cavity of the positioning portion 400 and extend into the guiding tube cavity 431, so as to abut against the distal end (i.e., the closed end) of the guiding tube cavity 431. By providing the guiding tube section 430, the guide wire is inserted into the guiding tube cavity 431, which is convenient for guiding the abutment of the guide wire and the positioning portion 400. At the same time, when the entire urinary catheter moves in the human urethra, the guiding tube section 430 can also provide guidance.
[0058] In addition, when the positioning portion 400 is a hollow structure composed of a plurality of positioning strips 420, the positioning strips 420 are initially arc-shaped to make the positioning portion 400 in an expanded state. The positioning strips 420 can be stretched by extending the guide wire into the guiding tube cavity 431, so that the positioning portion 400 changes from the expanded state to the contracted state, which is convenient for the implantation or withdrawal of the urinary catheter.
[0059] Please combine with Figures 3 to 4, in one embodiment, the drug - loaded balloon 200 includes a straight section 210 and two tapered sections, namely a first tapered section 220 and a second tapered section 230. The diameter of the straight section 210 is uniform. The diameters of the tapered sections are gradually changing. The two tapered sections are respectively connected to the proximal end and the distal end of the straight section 210, and the larger - diameter end of each tapered section is connected to the straight section 210. Among them, the first tapered section 220 is connected to the distal end of the straight section 210, and the second tapered section 230 is connected to the proximal end of the straight section 210. The angle between the generatrix of the tapered section (i.e., the second tapered section 230) connected to the proximal end of the straight section 210 and the central axis is greater than or equal to 30° and less than or equal to 45°.
[0060] When the outer diameter of the straight section of the drug - loaded balloon in the prior art is between 25 mm and 40 mm, the angle between the generatrix of the tapered section at its proximal end and the central axis is usually large, which is likely to damage the external sphincter and cause urinary incontinence.
[0061] In this embodiment, the outer diameter of the straight section 210 is greater than or equal to 25 mm and less than or equal to 40 mm. At the same time, the angle between the generatrix of the tapered section (i.e., the second tapered section 230) connected to the proximal end of the straight section 210 and the central axis is greater than or equal to 30° and less than or equal to 45°. Compared with the prior art, this angle range is smaller, which can reduce the damage of the drug - loaded balloon 200 to the external sphincter, thereby reducing the occurrence of urinary incontinence.
[0062] Please refer to Figure 5 , in one embodiment, the length of a single mesh opening 310 of the braided mesh 300 is greater than or equal to 0.1 mm and less than or equal to 0.5 mm. The width of a single mesh opening 310 of the braided mesh 300 is greater than or equal to 0.1 mm and less than or equal to 0.5 mm.
[0063] In one embodiment, the drug - loading structure is a drug coating or drug - loaded microneedles.
[0064] In one embodiment, the main components of the drug in the drug - loading structure include paclitaxel and its derivatives, or rapamycin and its derivatives.
[0065] In one embodiment, the drug coating can be applied by ultrasonic spraying, dip coating, manual coating, drop coating and other methods.
[0066] Please refer to Figure 3 and Figure 4, in one embodiment, the tube body 100 includes an outer tube 110, an inner tube 120, and a filling tube 130. The inner tube 120 and the filling tube 130 are disposed through the outer tube 110. The lumen of the inner tube 120 is a urine drainage channel, and the lumen of the filling tube 130 is a filling channel. The distal ends of the inner tube 120 and the filling tube 130 extend out of the outer tube 110 and are located within the drug-carrying balloon 200. The portion of the filling tube 130 located within the drug-carrying balloon 200 is provided with filling holes 131.
[0067] By introducing a liquid into the filling tube 130, the liquid can flow into the drug-carrying balloon 200 through the filling holes 131, thereby causing the drug-carrying balloon 200 to expand. Conversely, the liquid within the drug-carrying balloon 200 can be drawn out through the filling holes 131 into the filling tube 130 and discharged, causing the drug-carrying balloon 200 to contract.
[0068] In this embodiment, the proximal end of the drug-carrying balloon 200 is sealingly connected to the distal end of the outer tube 110, and at the proximal end of the drug-carrying balloon 200, the outer tube 110, the inner tube 120, and the filling tube 130 are sealingly connected to prevent the liquid within the drug-carrying balloon 200 from leaking out between the three. The distal end of the drug-carrying balloon 200 is sealingly connected to the inner tube 120 and the filling tube 130 respectively, and the distal end of the filling tube 130 is sealed to prevent the liquid within the drug-carrying balloon 200 from leaking out from the distal end.
[0069] In other embodiments, the tube body is not limited to the structure in the above embodiment and can also be a multi-lumen catheter, that is, the tube body is an integral structure with a urine drainage channel and a filling channel provided therein; or the above inner tube 120 and filling tube 130 are combined into one inner tube with at least two lumens (i.e., provided with a urine drainage channel and a filling channel). The portion of the filling channel located within the drug-carrying balloon has filling holes. The urine drainage channel communicates with the cavity of the positioning portion.
[0070] Please refer to Figures 1 to 3 , in one embodiment, the urinary catheter with a drug-carrying balloon further includes a connection joint 500 connected to the proximal end of the tube body 100. The connection joint 500 includes a urine drainage joint 510 and a filling joint 520 connected to each other. The urine drainage joint 510 communicates with the proximal end of the urine drainage channel, and the filling joint 520 communicates with the proximal end of the filling channel.
[0071] The urine drainage joint 510 can be used to connect to a urine collection bag to collect urine from the urine drainage channel. The filling joint 520 can be used to connect to an infusion device, so that a liquid can be input into the filling channel through the filling joint 520 by the infusion device, or drawn out from the filling channel through the filling joint 520.
[0072] Please refer to Figure 3, in one embodiment, a one-way valve 521 is provided inside the filling connector 520. The one-way valve 521 allows liquid to enter the filling channel through the filling connector 520, but does not allow the liquid to be discharged from the filling channel to the outside of the filling connector 520. Therefore, after the drug-loaded balloon 200 is expanded, it is not easy for the liquid to leak, so that the drug-loaded balloon 200 can stably maintain the expanded state, and thus the drug can continuously act on the prostate part.
[0073] In other embodiments, it may also be that a one-way valve is provided in the filling channel, which can also prevent liquid leakage after the drug-loaded balloon is expanded.
[0074] In one embodiment, the braided mesh 300 is a fiber braided mesh, that is, it is formed by braiding fiber filaments. The braided mesh 300 can be directly braided on the surface of the drug-loaded balloon 200 by fiber filaments. Or, the braided mesh 300 is first braided into a mesh structure by fiber filaments and then attached to the surface of the drug-loaded balloon 200.
[0075] Specifically, the braided mesh 300 can be made of a polymer material.
[0076] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as the scope described in this specification.
[0077] The above-described embodiments only represent several implementation manners of the present invention. The description is relatively specific and detailed, but it should not be construed as a limitation on the scope of the invention patent. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can still be made, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the present invention patent should be subject to the appended claims.
Claims
1. A urinary catheter with a drug-loaded balloon, characterized in that, The urinary catheter with a drug - loaded balloon includes: A tube body having an independent urine drainage channel and a filling channel; A drug - loaded balloon disposed at the distal end of the tube body. The drug - loaded balloon is in communication with the filling channel, and a drug - loading structure is provided on the outer surface of the drug - loaded balloon; A braided mesh that wraps around the periphery of the drug - loaded balloon, and the drug in the drug - loading structure is released from the mesh openings of the braided mesh.
2. The catheter with a drug-loaded balloon according to claim 1, characterized in that, It further includes a positioning portion. The positioning portion is disposed at the distal end of the tube body and is spaced from the distal end of the drug - loaded balloon. The interior of the positioning portion has a cavity that is in communication with the urine drainage channel. A urine drainage opening communicating with the cavity is provided in the circumferential direction of the positioning portion. The positioning portion has an expanded state and a contracted state, and the expanded outer diameter of the positioning portion in the expanded state is greater than the contracted outer diameter in the contracted state.
3. The catheter with a drug-loaded balloon according to claim 2, characterized in that, The positioning portion is made of an elastic material.
4. The catheter with a drug-loaded balloon according to claim 2, wherein The positioning portion includes a plurality of positioning strips arranged along the circumferential direction of the tube body. The proximal ends of the positioning strips are all connected to the tube body, the distal ends of the positioning strips are connected to each other, and the urine drainage openings are formed between adjacent positioning strips.
5. The catheter with a drug-loaded balloon according to claim 3 or 4, characterized in that, The distal end of the positioning portion has a guiding tube section. The guiding tube section has a guiding tube cavity for a guide wire to extend into. The proximal end of the guiding tube cavity is in communication with the cavity, and the distal end of the guiding tube section is a closed end.
6. The catheter with a drug-loaded balloon according to claim 1, characterized in that, The drug - loaded balloon includes a straight section and two tapered sections. The two tapered sections are respectively connected to the proximal end and the distal end of the straight section. The angle between the generatrix of the tapered section connected to the proximal end of the straight section and the central axis is greater than or equal to 30° and less than or equal to 45°. The outer diameter of the straight section is greater than or equal to 25 mm and less than or equal to 40 mm.
7. The catheter with a drug-loaded balloon according to claim 1, characterized in that, The length of a single mesh opening of the braided mesh is greater than or equal to 0.1 mm and less than or equal to 0.5 mm. The width of a single mesh opening of the braided mesh is greater than or equal to 0.1 mm and less than or equal to 0.5 mm.
8. The catheter with a drug-loaded balloon according to claim 1, characterized in that, The drug - loading structure is a drug coating or drug - loaded microneedles. The drugs in the drug - loading structure include: paclitaxel and its derivatives, or rapamycin and its derivatives.
9. The urinary catheter with a drug - loaded balloon according to claim 1, wherein The tube body includes an outer tube, an inner tube, and a filling tube. The inner tube and the filling tube are disposed through the outer tube. The lumen of the inner tube is the urine drainage channel, and the lumen of the filling tube is the filling channel; The distal ends of the inner tube and the filling tube extend out of the outer tube and are located inside the drug - loaded balloon. The portion of the filling tube located inside the drug - loaded balloon is provided with filling holes; The inner tube and the filling tube are two of the cavities of a multi - lumen tube, or the inner tube and the filling tube are independent pipe materials.
10. The catheter with a drug-loaded balloon according to claim 1, characterized in that, It further includes a connection joint connected to the proximal end of the tube body. The connection joint includes a urine drainage joint and a filling joint connected to each other. The urine drainage joint is in communication with the proximal end of the urine drainage channel, and the filling joint is in communication with the proximal end of the filling channel. A one - way valve is provided in the filling joint or the filling channel.
11. The catheter with a drug-loaded balloon according to claim 1, wherein The braided mesh is a fiber braided mesh; the braided mesh is formed by braiding fiber filaments on the surface of the drug-loaded balloon, or the braided mesh is first formed into a mesh by braiding fiber filaments and then attached to the surface of the drug-loaded balloon.