Prosthetic prostatic stent and method of making same

Abstract

The application discloses a kind of prostatic stents, comprising: stent wire, it is outward convex circular arc line type structure;Elastic isolation membrane cover, including stent cover and isolation membrane piece, stent cover is installed on stent wire.The application also discloses two kinds of prostatic stent manufacturing method.Compared with prior art, the stent wire of existing prostatic stent is insufficient in compression state support, and the problem of complex film process is solved.The application also discloses a kind of prostatic stent with balloon, by making the balloon of stent body lumen, to realize supporting stent wire, make stent wire show greater support to prostate tissue.Prostate tissue is forced to expand by balloon long-term inflation or intermittent inflation, and the growth of stent wire is avoided after the expansion of prostate tissue.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of prostate stents, in particular to a prostate stent and a manufacturing method thereof. BACKGROUND

[0002] In order to solve the problems of prostate hyperplasia and inflammation, prostate stent implantation has been greatly developed in China in recent years. The prostate stent can be placed in the urethral stenosis part through cystoscopy to expand the originally narrow and closed urethra. The stent can support the prostate hyperplasia part, and after a period of time, the broken hyperplasia flaps will necrose due to ischemia, so that after the prostate stent is removed, the urethra will not be squeezed again, and most of the patients with dysuria will restore the urination function after the placement of the urethral stent.

[0003] For example, a prostate stent and a stent delivery device are provided in Chinese patent 202411322426.9, wherein the stent wire support part is concave or flat, thus having the following deficiencies.

[0004] Deficiency one:

[0005] The prostate stent is in a compressed state when supporting the prostate tissue. The concave or flat design of the stent wire support part aggravates the concave degree in the compressed state, resulting in a loss of the supporting force of the stent design, and the design purpose cannot be fully achieved.

[0006] Deficiency two:

[0007] The isolation film structure design is not convenient for process implementation, the film coating process is complex, quality assurance is difficult, and the production cost is very high.

[0008] Deficiency three:

[0009] The prostate stent has insufficient supporting force when supporting the prostate tissue, and the prostate tissue not supported by the stent wire is easily wrapped together with the growth of the stent wire. SUMMARY

[0010] The present application aims to provide a prostate stent and a manufacturing method thereof to solve the problems of insufficient supporting force of the stent wire of the existing prostate stent in the compressed state and complex film coating process.

[0011] In order to achieve the above-mentioned purpose, on the one hand, the present application discloses a prostate stent, comprising:

[0012] The stent wire is in a outwardly convex arc line structure;

[0013] The elastic isolation film sleeve comprises a stent cover sleeve and an isolation film piece, the stent cover sleeve is sleeved on the stent wire, and the isolation film piece is offset to one side relative to the stent wire in the stent cover sleeve, or the isolation film piece corresponds to the position of the stent wire in the stent cover sleeve;

[0014] The stent support is provided with a support area, and the stent wire is in a circular arc line shape and has an outward protruding structure, so that when the stent wire is compressed, the circular arc line outward protrusion thereon generates a support force on the prostate tissue;

[0015] A step is arranged between the port of the stent cover sleeve and the stent wire, and glue is infiltrated into the stent cover sleeve, so that the port of the stent cover sleeve is bonded to the stent wire; when the stent cover sleeve is fixed by using the bonding mode of glue, the glue is accumulated at the step to form an inclination and a circular arc transition.

[0016] In another aspect, the application discloses a manufacturing method of the prostate stent.

[0017] S1, a plurality of positioning sleeves are assembled on the stent wire, and the material of the positioning sleeves is the same as that of the elastic isolation film sleeve;

[0018] S2, the stent wire is placed in the mold cavity of the film covering mold, and the positioning sleeves are used to position the stent wire;

[0019] S3, in the film covering mold, the film covering material covers the stent wire to form the elastic isolation film sleeve, and the film covering material covers the circumference of the stent wire, so that the positioning sleeves are integrated with the film covering material to form the stent cover sleeve of the elastic isolation film sleeve;

[0020] S4, the mold is opened, and the stent wire is taken out, and the film covering is completed.

[0021] The application further discloses a manufacturing method of the prostate stent.

[0022] S1, the prostate stent is placed in the mold cavity of the first film covering mold, and the stent wire of the prostate stent is fixed in the mold cavity by using the stent positioning pile;

[0023] S2, the film covering material is used to form the elastic isolation film sleeve on the stent wire, a plurality of positioning holes formed by the stent positioning pile are arranged on the isolation film piece of the elastic isolation film sleeve, a plurality of film covering defects formed by the stent positioning pile are arranged on the stent cover sleeve of the elastic isolation film sleeve, and the first film covering is realized;

[0024] S3, the prostate stent is placed in the mold cavity of the second film covering mold, the positioning holes and the film covering defects are filled after the film covering material is introduced into the mold cavity of the second film covering mold, the complete elastic isolation film sleeve is formed, and the second film covering is realized;

[0025] S4, the mold is opened, and the prostate stent is taken out, and the film covering is completed.

[0026] In summary, due to the adoption of the technical scheme, the beneficial effects of the present application are:

[0027] 1、In the present application, the stent wire of the nickel-titanium material is in a circular arc shape and outwardly convex structure, and the design purpose is to ensure that when the stent wire is compressed, the circular arc shape is outwardly convex, and has a certain supporting force on the prostate tissue. The elastic isolation film sleeve can prevent the prostate tissue from growing slowly after the prostate stent is placed, independently wrap the stent wire, and avoid the stent from being pulled out in the prostate tissue.

[0028] 2、In the present application, according to the different materials of the stent wire, chemical reagents are used to corrode and treat the surface of the stent wire, so that the stent covering sleeve and the stent wire are combined firmly, and relative displacement between the two during use of the prostate stent is avoided.

[0029] 3、In the present application, the stent wire is first assembled with a positioning sleeve, the stent wire is positioned in the mold during stent covering, and then the covering material is used to cover the stent wire. The positioning sleeve makes the thickness of the stent covering sleeve on the stent wire uniform, and the wall thickness difference of the stent covering sleeve is not more than 0.5 mm, so that the prostate stent is prevented from being broken due to the thin wall of the stent covering sleeve during use.

[0030] 4、In the present application, the material of the positioning sleeve is of the same category as the material of the elastic isolation film sleeve, so that the positioning sleeve can be integrated with the stent covering sleeve and the isolation film piece of the elastic isolation film sleeve.

[0031] 5、In the present application, in the prostate stent with a balloon, the balloon in the stent body lumen is inflated to support the stent wire, so that the stent wire has greater supporting force on the prostate tissue. The prostate tissue not supported by the stent wire is forced to expand, and the prostate tissue is prevented from growing to cover the stent wire after expansion. BRIEF DESCRIPTION OF DRAWINGS

[0032] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the drawings needed in the embodiments. It should be understood that the following drawings only show some embodiments of the present application, and therefore should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can also be obtained without creative labor.

[0033] Figure 1 Stereogram of a prostate stent scheme Figure 1 .

[0034] Figure 2 Stereogram of a prostate stent scheme Figure 2 .

[0035] Figure 3 is a front view of a prostate stent scheme one.

[0036] Figure 4 is a front view of a prostate stent scheme one. Figure 3 is a cross-sectional view of A-A of

[0037] Figure 5 is a cross-sectional view of B-B of Figure 3

[0038] Figure 6 is a partial enlarged view of C in Figure 5

[0039] Figure 7 is a structure diagram of a flexible isolation membrane sleeve design two in a prostate stent scheme one.

[0040] Figure 8 is a structure diagram of a flexible isolation membrane sleeve design two in a prostate stent scheme one. Figure 7 is a partial enlarged view of D in

[0041] Figure 9 is a schematic diagram of the installation of the positioning sleeve in a prostate stent manufacturing method scheme one Figure 1 .

[0042] Figure 10 is a schematic diagram of the installation of the positioning sleeve in a prostate stent manufacturing method scheme one Figure 2 .

[0043] Figure 11 is a schematic diagram of the installation of the positioning sleeve on the stent wire in a prostate stent manufacturing method scheme one Figure 1 .

[0044] Figure 12 is a schematic diagram of the installation of the positioning sleeve on the stent wire in a prostate stent manufacturing method scheme one Figure 2 .

[0045] Figure 13 is a schematic diagram of the installation of the flexible isolation membrane sleeve in a prostate stent manufacturing method scheme two Figure 1 .

[0046] Figure 14 is a schematic diagram of the installation of the flexible isolation membrane sleeve in a prostate stent manufacturing method scheme two Figure 2 .

[0047] Figure 15 is a schematic diagram of the installation of the flexible isolation membrane sleeve on the stent wire in a prostate stent manufacturing method scheme two Figure 1 .

[0048] Figure 16 is a schematic diagram of the installation of the flexible isolation membrane sleeve on the stent wire in a prostate stent manufacturing method scheme two​​Figure 2 .

[0049] Figure 17 is a structural schematic of a prostate stent scheme two Figure 1 .

[0050] Figure 18 is a structural schematic of a prostate stent scheme two Figure 2 .

[0051] Figure 19 is an E-E sectional view of Figure 17 .

[0052] Figure 20 is a sectional schematic of a ring-shaped covering fixation scheme two in a prostate stent scheme two

[0053] Figure 21 is a sectional schematic of a ring-shaped covering fixation scheme three in a prostate stent scheme two

[0054] Figure 22 is a local enlarged view of F in Figure 21 .

[0055] Figure 23 is a structural schematic of a prostate stent scheme three

[0056] Figure 24 is an F-F sectional view of Figure 23 .

[0057] Figure 25 is a local enlarged view of G in Figure 24 .

[0058] Figure 26 is a local enlarged view of H in Figure 24 .

[0059] Figure 27 is a structural schematic of a balloon catheter in a prostate stent scheme three

[0060] Figure 28 is an I-I sectional view of Figure 27 .

[0061] Legend:

[0062] 301, support area; 302, step;

[0063] 501, elastic isolation membrane sleeve; 601, isolation membrane piece; 602, stent covering sleeve;

[0064] 603, stent wire;

[0065] 801, positioning sleeve;

[0066] 1301, positioning hole; 1302, film defect;

[0067] 1901, annular film; 1902, connecting part;

[0068] 2201, first layer film; 2202, second layer film.

[0069] 2301, stent body; 2302, balloon catheter;

[0070] 2501, first gap cavity; 2502, first stent inner sleeve; 2503, first balloon step;

[0071] 2601, second gap cavity; 2602, second stent inner sleeve; 2603, second balloon step;

[0072] 2701, valve body; 2702, medium inlet pipe; 2703, balloon; 2704, guide rod. DETAILED DESCRIPTION

[0073] In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only some but not all of the embodiments of the present application. The components of the embodiments of the present application described and shown in the drawings herein can be arranged and designed in various different configurations.

[0074] Therefore, the following detailed description of the embodiments of the present application provided in the drawings is not intended to limit the scope of the claimed present application, but only represents selected embodiments of the present application. All other embodiments obtained by those of ordinary skill in the art based on the embodiments in the present application without creative labor are within the scope of protection of the present application.

[0075] It should be noted that: similar reference numerals and letters represent similar items in the following drawings, therefore, once an item is defined in one drawing, it does not need to be further defined and explained in subsequent drawings.

[0076] In the description of the embodiments of the present application, it should be noted that the orientation or position relationship indicated by the terms "upper", "inner" and the like is based on the orientation or position relationship shown in the drawings, or the orientation or position relationship in which the product of the present application is usually placed, which is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the indicated device or element must have a particular orientation, be constructed and operated in a particular orientation, therefore, it cannot be understood as a limitation on the present application.

[0077] In the description of the present application, it is also necessary to explain that, unless otherwise explicitly specified and limited, the terms "arrange", "mount", "connect", "connect" should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or integrally connected; it can be directly connected, or indirectly connected through an intermediate medium, or the communication inside two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0078] Embodiment 1

[0079] Please refer to Figures 1-8 In one aspect, the present application discloses a prostatic stent, comprising:

[0080] The support area 301 of the stent wire 603 in a free state is in a outwardly convex arc line structure;

[0081] In the prostatic tissue, the support area 301 of the stent wire 603 is in a fully supported state (in fact, the prostatic stent support state is in a compressed state, and there is no support force without compression). The support area 301 of the stent wire is in an outward expansion force, and the arc structure has strong anti-deformation ability, effectively ensuring the support force, and there is no sharp protrusion, avoiding the prostatic tissue covering, and facilitating the separation from the prostatic tissue.

[0082] The elastic isolation membrane sleeve 501 comprises a stent covering sleeve 602 and an isolation membrane 601, the stent covering sleeve 602 is sleeved on the stent wire 603, and the isolation membrane is offset to one side relative to the stent wire in the stent covering sleeve. For details, please refer to the accompanying drawings Figure 8 , or the isolation membrane is corresponding to the position of the stent wire in the stent covering sleeve. For details, please refer to the accompanying drawings Figure 6 ;

[0083] Please refer to Figures 3-4 A step 302 is arranged between the port of the stent covering sleeve 602 and the stent wire 603, and the glue is infiltrated into the stent covering sleeve 602, so that the port of the stent covering sleeve 602 is bonded with the stent wire 603. When the stent covering sleeve 602 is fixed by using the glue bonding method, the glue is accumulated at the step 302 to form an inclination and an arc transition.

[0084] So that the step 302 is smoothly transitioned. The step 302 can also accumulate material to form an inclination and an arc transition when the film is covered.

[0085] The elastic isolation membrane sleeve 501 is made of high-elastic polyurethane material, silicone or rubber. The elastic isolation membrane sleeve 501 is made of elastomer material, and considering the convenience of processing, high-elastic polyurethane material, silicone or rubber material is preferred.

[0086] The stent wire 603 is provided with a corrosion treatment layer on the surface. According to the different materials of the stent wire 603, the surface of the stent wire 603 is treated by using a chemical agent to corrode, so that the stent covering sleeve 602 is combined with the stent wire 603 firmly, and relative displacement of the two is avoided when the prostatic stent is used.

[0087] In addition, referring to the accompanying drawings Figure 5 The independent elastic isolation film sleeve 501 on the plurality of stent wires 603 can be extended and connected into one body.

[0088] Working principle: The prostatic stent is provided with a support area 301, and the stent wire 603 made of nickel-titanium material is in a circular arc line shape and outward protruding structure. The design purpose is to ensure that when the stent wire 603 is compressed, the circular arc line shape protrudes outward and has a certain support force on the prostate tissue. The elastic isolation film sleeve 501 can prevent the prostate tissue from growing slowly after the prostatic stent is placed, and independently wrap the stent wire 603, so that the stent cannot be pulled out in the prostate tissue.

[0089] Please refer to Figures 9-12 On the other hand, the application discloses a manufacturing method of the prostatic stent, comprising the following steps:

[0090] S1, a plurality of positioning sleeves 801 are assembled on the stent wire 603, and the material of the positioning sleeve 801 is the same as that of the elastic isolation film sleeve 501;

[0091] S2, the stent wire 603 is placed in the mold cavity of the film covering mold, and the positioning sleeve 801 is used for positioning the stent wire 603;

[0092] S3, in the film covering mold, the film covering material covers the stent wire 603 to form the elastic isolation film sleeve 501, and the film covering material covers the circumference of the stent wire 603, so that the positioning sleeve 801 is integrated with the film covering material to form the stent covering sleeve 602 of the elastic isolation film sleeve 501;

[0093] S4, the mold is opened, and the stent wire 603 is taken out, and the film covering is completed.

[0094] The positioning sleeve 801 is assembled on the stent wire 603 in advance, the stent wire 603 is positioned in the mold during the stent film covering, and then the film covering material covers the stent wire. The positioning sleeve 801 makes the thickness of the stent covering sleeve 602 on the stent wire 603 uniform, and the wall thickness difference of the stent covering sleeve 602 is not more than 0.5 mm, so that the prostatic stent is not broken due to the thin wall of the stent covering sleeve 602 when the prostatic stent is used.

[0095] The material of the positioning sleeve 801 is in the same category as that of the elastic isolation film sleeve 501, so that the positioning sleeve 801 can be integrated with the stent covering sleeve 602 and the isolation film piece 601 of the elastic isolation film sleeve 501 subsequently.

[0096] In addition, the elastic isolation film sleeve 501 can also be made of rubber material, and the process route is vulcanization molding, and the process parameters are determined according to the material characteristics.

[0097] The process parameters of the film coating are determined according to the material characteristics. The film coating material is liquid or solid, and the silicone material or high-elastic polyurethane is used. The molding material is solid, and the rubber, silicone material or high-elastic polyurethane is used.

[0098] Embodiment 2

[0099] The embodiment further makes the following improved technical solutions on the basis of the above-mentioned embodiment 1: The positioning sleeve 801 is installed on the stent wire 603 of the prostate stent, including at least three methods, and the specific installation method is as follows.

[0100] Method one:

[0101] In the step S1, the positioning sleeve 801 is sleeved on the stent wire 603 before riveting at both ends of the prostate stent, and the installation is realized without damaging the positioning sleeve 801.

[0102] Method two:

[0103] In the step S1, the positioning sleeve 801 is cut, and the cutting gap is arranged along the axis direction of the positioning sleeve 801. After the positioning sleeve 801 is expanded at the cutting position, it is sleeved on the stent wire 603.

[0104] Since the positioning sleeve 801 has good elasticity, after the positioning sleeve 801 is cut and sleeved on the stent wire 603, the positioning sleeve 801 can be closed after being sleeved, and is not easy to fall off. When the film is coated, the positioning sleeve 801 is integrated with the film coating material, and the quality of the elastic isolation film sleeve 501 is not affected.

[0105] Method three:

[0106] In the step S1, the positioning sleeve 801 is directly formed on the stent wire 603 by injection molding, film coating and vulcanization molding. The positioning sleeve 801 does not need to be prefabricated, and is directly formed on the stent wire 603, so that the distance between the two adjacent positioning sleeves 801 on the stent wire 603 can be avoided to change, and the subsequent film coating quality is improved.

[0107] Embodiment 3

[0108] The embodiment further makes the following improved technical solutions on the basis of the above-mentioned embodiment 1: The method of coating the film on the prostate stent is not unique, and the secondary film coating method can be used to manufacture the elastic isolation film sleeve on the stent wire 603. The specific process is as follows.

[0109] Please refer to Figures 13-16A manufacturing method of a prostatic stent, comprising the following steps:

[0110] S1, placing the prostatic stent in the first film covering mold cavity, and fixing the stent wire 603 of the prostatic stent in the mold cavity by using the stent positioning pile;

[0111] S2, forming the elastic isolation film sleeve 501 on the stent wire 603 by using the film covering material, and setting a plurality of positioning holes 1301 on the isolation film sheet 601 of the elastic isolation film sleeve 501 formed by the stent positioning pile, and setting a plurality of film covering defects 1302 on the stent covering sleeve 602 of the elastic isolation film sleeve 501 formed by the stent positioning pile, to realize the first film covering;

[0112] S3, placing the prostatic stent in the second film covering mold cavity, and filling the positioning holes 1301 and the film covering defects 1302 after the film covering material is introduced into the mold cavity of the second film covering mold, to form the complete elastic isolation film sleeve 501 and realize the second film covering;

[0113] S4, opening the mold, taking out the prostatic stent, and completing the film covering.

[0114] The stent wire 603 on the prostatic stent forms the elastic isolation film sleeve 501 through twice film covering, and the forming efficiency of the elastic isolation film sleeve 501 is improved.

[0115] Embodiment 4

[0116] Please refer to Figures 17-20 The application further discloses a prostatic stent film covering design which adopts an annular film 1901 to replace the elastic isolation film sleeve 501.

[0117] Specifically, a prostatic stent is disclosed, comprising:

[0118] The stent wire 603 is in a circular arc line structure which protrudes outward;

[0119] The annular film 1901 is fixedly installed on the stent wire 603;

[0120] The annular film 1901 on the prostatic stent is in a concave relaxed state.

[0121] The annular film 1901 is adopted to replace the elastic isolation film sleeve 501, one annular film 1901 covers all the stent wires 603 of the prostatic stent, prevents the prostatic tissue from growing slowly after the prostatic stent is placed, independently wrapping the stent wire 603, and avoids the stent from being unable to be pulled out in the prostatic tissue.

[0122] Embodiment 5

[0123] The embodiment is further improved on the basis of the above-mentioned embodiment 4, and the following technical solutions are adopted: when the annular film 1901 composed of a single-layer film is fixed with the stent wire, two fixing modes can be adopted.

[0124] One is that the film is connected with the stent wire 603, but the inner side of the film is not connected, the outer side surface of the stent wire is bonded with the inner wall of the annular film, the surface of the stent wire is locally fixed with the annular film, and details are shown in Figures 17-19 .

[0125] Another is that on the basis of the film being fixed with the stent wire 603, the inner side of the film of the annular film 1901 is locally fixed to form a connecting part 1902, the annular film completely covers the circumferential surface of the stent wire, the stent wire 603 is fully positioned, and the position deviation of the annular film 1901 and the stent wire 603 is effectively prevented, and details are shown in Figure 20 .

[0126] Embodiment 6

[0127] The embodiment is further improved on the basis of the above-mentioned embodiment 4, and the following technical solutions are adopted: unlike the annular film 1901 composed of a single-layer film in the embodiment 4, the annular film is fixed with the stent wire.

[0128] Embodiment 7

[0129] As shown in Figures 21-22 , the embodiment is further improved on the basis of the above-mentioned embodiment 4, and the following technical solutions are adopted: the annular film 1901 can adopt a double-layer film design, specifically a first layer film 2201 and a second layer film 2202. The first layer film 2201 and the second layer film 2202 are locally fixed together and completely cover the stent wire 603 in the circumference.

[0130] The first layer film 2201, the second layer film 2202 and the stent wire are bonded together and cannot slide relative to each other.

[0131] Embodiment 8

[0132] As shown in Figures 23-28 , the embodiment discloses a prostatic stent, which comprises:

[0133] a stent body 2301, on which a stent wire is arranged in an outwardly protruding circular arc line structure;

[0134] a balloon catheter 2302, which comprises a valve body 2701, a medium inlet pipe 2702, a balloon 2703 and a guide rod 2704, the valve body 2701 is arranged at one end of the medium inlet pipe 2702, one end of the balloon 2703 is connected with the medium inlet pipe 2702, and the opposite end is connected with the guide rod 2704;

[0135] The first stent inner sleeve 2502 and the second stent inner sleeve 2602 are arranged on the stent body 2301, the medium inlet pipe 2702 penetrates the inner cavity of the first stent inner sleeve 2502, the medium inlet pipe 2702 is in clearance fit with the first stent inner sleeve 2502, a first clearance cavity 2501 is formed between the medium inlet pipe 2702 and the inner wall of the first stent inner sleeve 2502, the first clearance cavity 2501 is used for passing urine, and the first balloon step 2503 is used for limiting the relative sliding between the medium inlet pipe 2702 and the first stent inner sleeve 2502;

[0136] The guide rod 2704 penetrates the inner cavity of the second stent inner sleeve 2602 and is in clearance fit, the guide rod 2704 and the inner cavity of the second stent inner sleeve 2602 form a second clearance cavity 2601, urine can pass through the second clearance cavity 2601, and the second balloon step 2603 is used for limiting the relative sliding between the guide rod 2704 and the second stent inner sleeve 2602;

[0137] The balloon 2703 is limited in the inner cavity of the stent body 2301 in the inflated state or the non-inflated state.

[0138] The medium inlet pipe 2702 is used for inlets of gas or liquid which can inflate the balloon 2703.

[0139] The medium inlet pipe 2702 and the first stent inner sleeve 2502 can slide relatively, but the relative sliding cannot exceed the first balloon step 2503. Similarly, the guide rod 2704 and the second stent inner sleeve 2602 slide relatively, and the relative sliding thereof cannot exceed the second balloon step 2603.

[0140] Working principle: Because the support force of the prostatic stent is insufficient when supporting the prostate tissue, the prostate tissue not supported by the stent wire is easy to grow together and cover the stent wire. In the application, the stent wire is supported by inflating the balloon 2703 in the inner cavity of the stent body 2301, so that the stent wire has greater support force on the prostate tissue. Long-term inflation of the balloon 2703 also forces the prostate tissue not supported by the stent wire to expand, so that the prostate tissue expands and avoids growing to cover the stent wire. The balloon 2703 can also be intermittently inflated, and the intermittent inflation of the balloon 2703 also forces the prostate tissue not supported by the stent wire to expand, so that the intermittent expansion of the prostate tissue also avoids growing to cover the stent wire.

[0141] The above is only the preferred specific implementation of the application, but the protection scope of the application is not limited to this, any person skilled in the art can make equivalent replacement or change according to the technical scheme and the inventive concept of the application within the technical range disclosed by the application, which should be covered in the protection scope of the application.

Claims

1. A prostate stent, characterized in that, include: The support wire has an outwardly convex arc-shaped structure; An elastic isolation diaphragm sleeve includes a support cover and an isolation diaphragm. The support cover is fitted onto the support wires, and the isolation diaphragm is offset to one side relative to the support wires inside the support cover, or the isolation diaphragm is positioned corresponding to the support wires inside the support cover. The prostate stent has a support area, and the stent wire is an arc-shaped, outwardly convex structure, so that when the stent wire is compressed, its arc-shaped outward convexity provides support to the prostate tissue. A step is provided between the port of the support sleeve and the support wire. Glue is injected into the support sleeve to bond the port of the support sleeve to the support wire. When the support sleeve is fixed by glue bonding, glue is accumulated at the step to form a slope and arc transition.

2. The prostate stent according to claim 1, characterized in that, The elastic isolation membrane sleeve is made of high-elastic polyurethane, silicone, or rubber, and the surface of the support wire is provided with an corrosion treatment layer.

3. A method for manufacturing a prostate stent as described in claim 1 or 2, characterized in that, Includes the following steps: S1. Assemble multiple positioning sleeves on the support wires. The material of the positioning sleeves is the same as that of the elastic isolation membrane sleeve. S2. Place the support wire into the mold cavity of the coating mold and use the positioning sleeve to position the support wire. S3. In the coating mold, the coating material covers the support wire to form an elastic isolation film sleeve. The coating material covers the circumference of the support wire, so that the positioning sleeve and the coating material are integrated to form a support covering sleeve with an elastic isolation film sleeve. S4. Open the mold, remove the support wire, and complete the film coating.

4. The method for manufacturing a prostate stent according to claim 3, characterized in that, In step S1, the positioning cannula is first fitted onto the stent wire before the two ends of the prostate stent are riveted together.

5. The method for manufacturing a prostate stent according to claim 3, characterized in that, In step S1, the positioning sleeve is cut open, and the cut is arranged along the axial direction of the positioning sleeve. After the positioning sleeve is opened at the cut, it is fitted onto the support wire.

6. The method for manufacturing a prostate stent according to claim 4, characterized in that, In step S1, the positioning sleeve is directly formed onto the support wire through injection molding, film coating, and vulcanization molding.

7. A method for manufacturing a prostate stent as described in claim 1 or 2, characterized in that, Includes the following steps: S1. Place the prostate stent into the mold cavity of the first covered mold, and use stent positioning posts to fix the stent wire of the prostate stent in the mold cavity; S2. The coating material is formed into an elastic isolation membrane sleeve on the support wire. The isolation membrane of the elastic isolation membrane sleeve is provided with several positioning holes formed by the support positioning stakes. The support covering sleeve of the elastic isolation membrane sleeve is provided with several coating defects formed by the support positioning stakes, thus realizing the first coating. S3. Place the prostate stent into the mold cavity of the second covering mold. After the covering material is introduced into the mold cavity of the second covering mold, it fills the positioning holes and covering defects to form a complete elastic isolation membrane, thus realizing the second covering. S4. Open the mold, remove the prostate stent, and complete the covering.

8. A prostate stent, characterized in that, include: The support wire has an outwardly convex arc-shaped structure; An annular film is fixedly mounted on the support wire; Among them, the annular covering on the prostate stent is in a concave, relaxed state; The stent wire has an arc-shaped, outward-convex structure, so that when the stent wire is compressed, its arc-shaped outward convexity provides support to the prostate tissue.

9. A prostate stent according to claim 8, characterized in that, The inner side of the annular membrane is bonded to form a connecting part, and the annular membrane completely covers the circumferential surface of the support wire, or the outer surface of the support wire is bonded to the inner wall of the annular membrane, so that the surface of the support wire is partially bonded and fixed to the annular membrane.

10. A prostate stent, characterized in that, include: The support body has support wires on it, and the support wires have an outwardly convex arc-shaped structure. A balloon catheter includes a valve body, a medium inlet tube, a balloon, and a guide rod. The valve body is disposed at one end of the medium inlet tube, and one end of the balloon is connected to the medium inlet tube, while the other end is connected to the guide rod. The stent body is provided with a first stent inner tube and a second stent inner tube. The media inlet tube penetrates the inner cavity of the first stent inner tube. The media inlet tube and the first stent inner tube are in clearance fit. A first gap cavity is formed between the media inlet tube and the inner wall of the first stent inner tube. The first gap cavity is used to allow urine to pass through. The first balloon step is used to restrict the relative sliding between the media inlet tube and the first stent inner tube. The guide rod penetrates the inner cavity of the second stent inner tube and forms a clearance fit. The guide rod and the inner cavity of the second stent inner tube form a second gap cavity through which urine flows. The second balloon step is used to limit the relative sliding between the guide rod and the second stent inner tube. The balloon is confined within the cavity of the stent body, whether it is inflated or not.

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