Prostate stent and manufacturing method thereof

Abstract

The invention discloses a prostate stent which comprises a stent wire which is of an arc linear structure protruding outwards. And the elastic isolating membrane sleeve comprises a stent coating sleeve and an isolating membrane, and the stent coating sleeve is sleeved on the stent wire. The invention further discloses two manufacturing methods of the prostate stent. Compared with the prior art, the problems that a stent wire of an existing prostate stent is insufficient in supporting force in a compressed state, and the film covering process is complex are solved. The invention further discloses a prostate stent with the balloon, the stent wire is supported by filling the balloon in the inner cavity of the stent body, and the stent wire shows larger supporting force on prostate tissue. The balloon is filled for a long time or intermittently, so that the prostate tissue which is not supported by the stent wire is forced to expand, and the prostate tissue is prevented from growing and covering the stent wire after being expanded.

Description

Technical Field

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

[0002] In order to solve the problems of prostate hyperplasia and prostate inflammation in patients, prostate stent implantation has been greatly developed in my country in recent years. The prostate stent can be placed in the narrow part of the urethra through a cystoscope to expand the originally narrow and closed urethra. The stent can rupture the prostate hyperplasia part. After a period of time, the ruptured hyperplastic valves will necrotize due to ischemia. Therefore, after the prostate stent is removed, the urethra will not be squeezed again, so that most patients with dysuria can restore urination function after the placement of the urethral stent.

[0003] For example, Chinese Patent No. 202411322426.9 provides a prostate stent and a stent delivery device, in which the stent wire support portion is concave or straight in design, and thus has the following shortcomings.

[0004] One of the shortcomings:

[0005] The prostate stent is in a compressed state when supporting the prostate tissue. The concave or straight design of the stent wire support part is more concave under the compressed state, resulting in a loss of the support force that the stent design should have, and the design purpose cannot be fully achieved;

[0006] The second shortcoming:

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

[0008] Disadvantage three:

[0009] The prostate stent does not have sufficient support force when supporting the prostate tissue, and the prostate tissue that is not supported by the prostate stent wires can easily grow together with the stent wires. Summary of the invention

[0010] The purpose of the present invention is to provide a prostate stent and a manufacturing method thereof, so as to solve the problems that the stent wire of the existing prostate stent has insufficient supporting force in a compressed state and a complicated coating process.

[0011] In order to achieve the above object, on the one hand, the present invention discloses a prostate stent, comprising:

[0012] The stent wire has an outwardly convex arc-shaped structure;

[0013] An elastic isolation membrane sleeve, which includes a stent covering sleeve and an isolation membrane sheet, wherein the stent covering sleeve is sleeved on the stent wire, and the isolation membrane sheet is offset to one side relative to the stent wire in the stent covering sleeve, or the isolation membrane sheet corresponds to the position of the stent wire in the stent covering sleeve;

[0014] A support area is provided on the prostate stent, and the stent wire is an arc-shaped, outwardly protruding structure, so that when the stent wire is compressed, the arc-shaped outward protrusion on it generates a supporting force on the prostate tissue;

[0015] A step is provided between the port of the stent covering sleeve and the stent wire, and glue is infiltrated into the stent covering sleeve to bond the port of the stent covering sleeve to the stent wire. When the stent covering sleeve is fixed by glue bonding, glue is accumulated at the step to form an inclination and arc transition.

[0016] In another aspect, the present invention discloses a method for manufacturing a prostate stent, comprising the following steps:

[0017] S1. Assemble multiple sections of positioning sleeves on the stent wire, and the material of the positioning sleeves is the same as that of the elastic isolation membrane sleeve;

[0018] S2, placing the stent wire into the mold cavity of the film-covering mold, and positioning the stent wire using a positioning sleeve;

[0019] S3, in the coating mold, the coating material covers the stent wire to form an elastic isolation membrane sleeve, and the coating material covers the circumference of the stent wire, so that the positioning sleeve and the coating material are integrated to form a stent covering sleeve of the elastic isolation membrane sleeve;

[0020] S4, open the mold, take out the stent wire, and complete the coating.

[0021] The present invention also discloses a method for manufacturing a prostate stent, comprising the following steps:

[0022] S1, placing a prostate stent in a mold cavity of a first coating mold, and fixing the stent wire of the prostate stent in the mold cavity using a stent positioning pile;

[0023] S2, the coating material is formed into an elastic isolation membrane sleeve on the stent wire, the isolation membrane sheet of the elastic isolation membrane sleeve is provided with a plurality of positioning holes formed by the stent positioning piles, and the stent covering sleeve of the elastic isolation membrane sleeve is provided with a plurality of coating defects formed by the stent positioning piles, thereby achieving the first coating;

[0024] S3, placing the prostate stent into the mold cavity of the second coating mold, and after the coating material is passed into the mold cavity of the second coating mold, the positioning holes and coating defects are filled to form a complete elastic isolation membrane sleeve, thereby achieving the second coating;

[0025] S4. Open the mold, take out the prostate stent, and complete the coating.

[0026] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are:

[0027] 1. In the present invention, the stent wire of the nickel-titanium material is an arc-shaped, outwardly protruding structure. The design purpose is to ensure that when the stent wire is compressed, its arc-shaped protrusion is outwardly protruding, and it has a certain support force on the prostate tissue. The elastic isolation membrane sleeve can prevent the prostate tissue from growing slowly after the prostate stent is implanted, and independently wrap the stent wire to prevent the stent from being unable to be pulled out of the prostate tissue.

[0028] 2. In the present invention, according to the different materials of the stent wire, chemical reagents are used to corrode the surface of the stent wire so that the stent covering sleeve is firmly combined with the stent wire to avoid relative displacement between the two when the prostate stent is used.

[0029] 3. In the present invention, the stent wire is firstly assembled with a positioning sleeve, and when the stent is coated, the stent wire is positioned in the mold, and then the coating material is coated on the stent wire. The positioning sleeve makes the thickness of the stent coating sleeve on the stent wire uniform, and the difference in the wall thickness of the stent coating sleeve does not exceed 0.5 mm, so as to avoid the prostate stent from being broken due to the thin wall of the stent coating sleeve when in use.

[0030] 4. In the present invention, the material of the positioning sleeve is of the same type as the material of the elastic isolation membrane sleeve, so that the positioning sleeve can be integrated with the support covering sleeve and the isolation membrane sheet of the elastic isolation membrane sleeve later.

[0031] 5. In the present invention, in the prostate stent with a balloon, the balloon in the inner cavity of the stent body is filled to support the stent wire, so that the stent wire can show greater support for the prostate tissue. The balloon is filled for a long time or intermittently, so that the prostate tissue not supported by the stent wire is forced to expand, and the prostate tissue is prevented from growing and covering the stent wire after expansion. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments are briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without creative work.

[0033] Figure 1 A three-dimensional diagram of a prostate stent scheme 1 Figure 1 .

[0034] Figure 2 A three-dimensional diagram of a prostate stent scheme 1 Figure 2 .

[0035] Figure 3 This is a schematic diagram of the main view angle structure of a prostate stent scheme 1.

[0036] Figure 4 for Figure 3 AA section view.

[0037] Figure 5 for Figure 3 BB section view.

[0038] Figure 6 for Figure 5 A partial enlarged view of point C in the middle.

[0039] Figure 7 This is a schematic diagram of the structure of the elastic isolation membrane sleeve design 2 in the first prostate stent scheme.

[0040] Figure 8 for Figure 7 A partial enlarged view of point D in the middle.

[0041] Fig. 9 Schematic diagram of the installation of the positioning sleeve in the first method of manufacturing a prostate stent Figure 1 .

[0042] Fig.10 Schematic diagram of the installation of the positioning sleeve in the first method of manufacturing a prostate stent Figure 2 .

[0043] Fig.11 Schematic diagram of the assembly of the positioning sleeve on the stent wire in the first scheme of a method for manufacturing a prostate stent Figure 1 .

[0044] Fig.12 Schematic diagram of the assembly of the positioning sleeve on the stent wire in the first scheme of a method for manufacturing a prostate stent Figure 2 .

[0045] Fig.13 Schematic diagram of the assembly of the elastic isolation membrane sleeve in the second method for manufacturing a prostate stent Figure 1 .

[0046] Fig.14 Schematic diagram of the assembly of the elastic isolation membrane sleeve in the second method for manufacturing a prostate stent Figure 2 .

[0047] Fig.15 Schematic diagram of the assembly of the elastic isolation membrane sleeve on the stent wire in the second method of manufacturing a prostate stent Figure 1 .

[0048] Fig.16 Schematic diagram of the assembly of the elastic isolation membrane sleeve on the stent wire in the second method of manufacturing a prostate stent Figure 2 .

[0049] Fig.17 A schematic diagram of the structure of a prostate stent scheme 2 Figure 1 .

[0050] Fig.18 A schematic diagram of the structure of a prostate stent scheme 2 Figure 2 .

[0051] Fig.19 for Fig.17 EE section view.

[0052] Fig. 20 It is a cross-sectional schematic diagram of a second annular covering fixation scheme in a second prostate stent scheme.

[0053] Fig.21 It is a cross-sectional schematic diagram of annular covering fixation scheme three in prostate stent scheme two.

[0054] Fig. 22 for Fig.21 A partial enlarged view of point F in the middle.

[0055] Fig.23 This is a schematic diagram of the structure of a prostate stent scheme three.

[0056] Fig.24 for Fig.23 FF section view.

[0057] Fig.25 for Fig.24 A partial enlarged view of point G in the middle.

[0058] Fig.26 for Fig.24 A partial enlarged view of point H in the middle.

[0059] Fig. 27 This is a schematic diagram of the structure of the balloon catheter in a prostate stent scheme three.

[0060] Fig.28 for Fig. 27 II-direction cross-sectional view.

[0061] Legend:

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

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

[0064] 603, stent wire;

[0065] 801, positioning sleeve;

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

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

[0068] 2201, the first layer of membrane; 2202, the second layer of membrane.

[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 tube; 2703, balloon; 2704, guide rod. DETAILED DESCRIPTION

[0073] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Generally, the components of the embodiments of the present invention described and shown in the drawings here can be arranged and designed in various different configurations.

[0074] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the invention claimed for protection, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0075] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in subsequent drawings.

[0076] In the description of the embodiments of the present invention, it should be noted that the terms "upper", "inner", etc. indicate directions or positional relationships based on the directions or positional relationships shown in the accompanying drawings, or are directions or positional relationships in which the inventive product is usually placed when in use. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific direction, be constructed and operated in a specific direction, and therefore should not be understood as a limitation on the present invention.

[0077] In the description of the present invention, it is also necessary to explain that, unless otherwise clearly specified and limited, the terms "set", "install", "connect", and "connect" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be the internal communication of two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0078] Example 1

[0079] See also Figure 1-8 In one aspect, the present invention discloses a prostate stent, comprising:

[0080] The support wire 603, in a free state, has a support area 301 that is an outwardly convex arc-shaped structure;

[0081] The support area 301 of the stent wire 603 is completely in a supporting state in the prostate tissue (in fact, the support state of the prostate stent is compressed, and there is no supporting force without compression). The support area 301 of the stent wire is fully manifested as an outward expansion force. The arc structure has a strong anti-deformation ability and effectively guarantees the supporting force. At the same time, there are no sharp protrusions to avoid the prostate tissue from covering, which is convenient for detaching from the prostate tissue.

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

[0083] See also Figure 3-4 A step 302 is provided between the port of the stent covering sleeve 602 and the stent wire 603. Glue is infiltrated into the stent covering sleeve 602 to bond the port of the stent covering sleeve 602 to the stent wire 603. When the stent covering sleeve 602 is fixed by glue bonding, glue is accumulated at the step 302 to form an inclination and arc transition.

[0084] The step 302 has a smooth transition. The step 302 can also be deposited with materials to form a slope and arc transition during lamination.

[0085] The elastic isolation membrane sleeve 501 is made of a highly elastic polyurethane material, silicone or rubber. The elastic isolation membrane sleeve 501 is made of an elastomeric material, and in consideration of the convenience of processing, highly elastic polyurethane material, silicone or rubber material is preferred.

[0086] The surface of the stent wire 603 is provided with a corrosion treatment layer. According to the different materials of the stent wire 603, the surface of the stent wire 603 is corroded by using chemical reagents, so that the stent covering sleeve 602 and the stent wire 603 are firmly combined to avoid relative displacement between the two when the prostate stent is used.

[0087] In addition, see Appendix Figure 5 , the independent elastic isolation membrane sleeves 501 on the multiple stent wires 603 can be extended and connected into one.

[0088] Working principle: The prostate stent is provided with a support area 301, and the stent wire 603 made of nickel-titanium material is an arc-shaped, outwardly protruding structure. The design purpose is to ensure that when the stent wire 603 is compressed, its arc-shaped shape protrudes outward, which has a certain support force on the prostate tissue. The elastic isolation membrane sleeve 501 can prevent the prostate tissue from growing slowly after the prostate stent is implanted, and independently wrap the stent wire 603 to prevent the stent from being unable to be pulled out of the prostate tissue.

[0089] See also Figure 9-12 On the other hand, the present invention discloses a method for manufacturing a prostate stent, comprising the following steps:

[0090] S1. Assemble multiple sections of positioning sleeves 801 on the stent wire 603. The material of the positioning sleeves 801 is the same as that of the elastic isolation membrane sleeve 501.

[0091] S2, placing the stent wire 603 into the mold cavity of the film-covering mold, and using the positioning sleeve 801 to achieve the positioning of the stent wire 603:

[0092] S3, in the film-coating mold, the film-coating material covers the stent wire 603 to form an elastic isolation membrane sleeve 501, and the film-coating material covers the circumference of the stent wire 603, so that the positioning sleeve 801 and the film-coating material are integrated to form a stent covering sleeve 602 of the elastic isolation membrane sleeve 501;

[0093] S4, open the mold, take out the stent wire 603, and complete the coating.

[0094] The stent wire 603 is first assembled with the positioning sleeve 801. When the stent is coated, the stent wire 603 is positioned in the mold, and then the coating 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 does not exceed 0.5 mm, so as to avoid the prostate stent from being broken due to the thin wall of the stent covering sleeve 602 when it is used.

[0095] The material of the positioning sleeve 801 is of the same type as that of the elastic isolation membrane sleeve 501 , so that the positioning sleeve 801 can be integrated with the support covering sleeve 602 and the isolation membrane sheet 601 of the elastic isolation membrane sleeve 501 later.

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

[0097] The process parameters of lamination are determined according to the material properties. The lamination material is liquid or solid, using silicone material or highly elastic polyurethane; the molding material is solid, using rubber, silicone material or highly elastic polyurethane.

[0098] Example 2

[0099] This embodiment further provides the following improved technical solutions based on the above-mentioned embodiment 1: the installation of the positioning sleeve 801 on the stent wire 603 on the prostate stent includes at least 3 methods, and the specific installation methods are as follows.

[0100] Method 1:

[0101] In the step S1 , the positioning sleeve 801 is firstly put on the stent wire 603 before riveting the two ends of the prostate stent, so as to achieve installation without damaging the positioning sleeve 801 .

[0102] Method 2:

[0103] In step S1 , the positioning sleeve 801 is cut, and the cutting slit is arranged along the axial direction of the positioning sleeve 801 . The positioning sleeve 801 is stretched open at the cut part and then sleeved on the stent wire 603 .

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

[0105] Method 3:

[0106] In step S1, the positioning sleeve 801 is directly molded onto the stent wire 603 by injection molding, coating, and vulcanization molding. There is no need to pre-position the positioning sleeve 801, and directly molding it on the stent wire 603 can avoid changes in the distance between two adjacent positioning sleeves 801 on the stent wire 603, thereby improving the subsequent coating quality.

[0107] Example 3

[0108] This embodiment further provides the following improved technical solutions based on the above embodiment 1: there is not only one method for coating the prostate stent, and a secondary coating method can be used to make the elastic isolation membrane sleeve on the stent wire 603. The specific process is as follows.

[0109] See also Figure 13-16, a method for making a prostate stent, comprising the following steps:

[0110] S1, placing a prostate stent in a mold cavity of a first coating mold, and fixing the stent wire 603 of the prostate stent in the mold cavity using a stent positioning pile;

[0111] S2, the coating material is formed into an elastic isolation membrane sleeve 501 on the stent wire 603, the isolation membrane sheet 601 of the elastic isolation membrane sleeve 501 is provided with a plurality of positioning holes 1301 formed by the stent positioning piles, and the stent covering sleeve 602 of the elastic isolation membrane sleeve 501 is provided with a plurality of coating defects 1302 formed by the stent positioning piles, thereby achieving the first coating;

[0112] S3, placing the prostate stent into the mold cavity of the second coating mold, and after the coating material is passed into the mold cavity of the second coating mold, filling the positioning holes 1301 and the coating defects 1302 to form a complete elastic isolation membrane sleeve 501, thereby achieving the second coating;

[0113] S4. Open the mold, take out the prostate stent, and complete the coating.

[0114] The stent wire 603 on the prostate stent is coated twice to form an elastic isolation membrane sleeve 501, thereby improving the molding efficiency of the elastic isolation membrane sleeve 501.

[0115] Example 4

[0116] See also Figure 17-20 The present invention also discloses a prostate stent covering design that uses an annular covering 1901 to replace the elastic isolation membrane sleeve 501.

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

[0118] The stent wire 603 is in an outwardly protruding arc-shaped structure;

[0119] An annular coating 1901, which is fixedly mounted on the stent wire 603;

[0120] Among them, the annular coating 1901 on the prostate stent is in a concave and relaxed state.

[0121] An annular coating 1901 is used to replace the elastic isolation membrane sleeve 501. An annular coating 1901 covers all the stent wires 603 of the prostate stent to prevent the prostate tissue from slowly growing and independently wrapping the stent wires 603 after the prostate stent is implanted, thereby preventing the stent from being unable to be pulled out of the prostate tissue.

[0122] Example 5

[0123] This embodiment further provides the following improved technical solution based on the above-mentioned embodiment 4: when the annular coating 1901 composed of a single-layer membrane sheet is fixed to the stent wire, two fixing methods can be adopted.

[0124] One is that the membrane is connected to the stent wire 603, but the inner side of the membrane is not connected, and the outer surface of the stent wire is bonded to the inner wall of the annular coating, so that the surface of the stent wire and the annular coating are partially attached and fixed. For details, please refer to Figure 17-19 ;

[0125] The other is that on the basis of the connection and fixation between the membrane and the stent wire 603, the inner side of the membrane of the annular coating 1901 is fitted to form a connecting portion 1902, and the annular coating completely covers the circumferential surface of the stent wire, fully positioning the stent wire 603, and effectively preventing the position deviation of the annular coating 1901 and the stent wire 603. For details, please refer to Fig. 20 .

[0126] Example 6

[0127] This embodiment further provides the following improved technical solution based on the above-mentioned embodiment 4: Different from the embodiment 4, the annular coating 1901 composed of a single-layer membrane is fixed to the stent wire.

[0128] Example 7

[0129] See also Figure 21-22 Based on the above-mentioned embodiment 4, this embodiment further provides the following improved technical solutions: the annular covering 1901 can be designed as a double-layer membrane, specifically a first membrane 2201 and a second membrane 2202. The first membrane 2201 and the second membrane 2202 are bonded together and completely cover the stent wire 603 on the circumference.

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

[0131] Example 8

[0132] See also Figure 23-28 This embodiment discloses a prostate stent, comprising:

[0133] The stent body 2301 is provided with a stent wire, and the stent wire is in an outwardly protruding arc-shaped structure;

[0134] The balloon catheter 2302 includes a valve body 2701, a medium inlet tube 2702, a balloon 2703 and a guide rod 2704. The valve body 2701 is disposed at one end of the medium inlet tube 2702. One end of the balloon 2703 is connected to the medium inlet tube 2702 and the other end thereof is connected to the guide rod 2704.

[0135] The stent body 2301 is provided with a first stent inner sleeve 2502 and a second stent inner sleeve 2602, a medium introduction tube 2702 penetrates the inner cavity of the first stent inner sleeve 2502, the medium introduction tube 2702 and the first stent inner sleeve 2502 are clearance-matched, a first clearance cavity 2501 is formed between the medium introduction tube 2702 and the inner wall of the first stent inner sleeve 2502, the first clearance cavity 2501 is used for passing urine, and a first balloon step 2503 is used for limiting the relative sliding between the medium introduction tube 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 forms a clearance fit. The guide rod 2704 and the inner cavity of the second stent inner sleeve 2602 form a second clearance cavity 2601, and urine can flow through the second clearance cavity 2601. The second balloon step 2603 is used to limit the relative sliding between the guide rod 2704 and the second stent inner sleeve 2602.

[0137] The balloon 2703 is confined within the inner cavity of the stent body 2301 in either a filled state or a non-filled state.

[0138] The medium introduction tube 2702 is used to introduce gas or liquid for filling the balloon 2703 .

[0139] The medium inlet tube 2702 can slide relative to the first support inner sleeve 2502, but the relative sliding cannot exceed the first balloon step 2503. Similarly, the guide rod 2704 and the second support inner sleeve 2602 can slide relative to each other, but their relative sliding cannot exceed the second balloon step 2603.

[0140] Working principle: Since the prostate stent has insufficient support force when supporting the prostate tissue, the prostate tissue that is not supported by the prostate stent wire can easily cover the stent wire and grow together. In the present invention, the balloon 2703 in the inner cavity of the stent body 2301 is filled to support the stent wire, so that the stent wire can show greater support for the prostate tissue. Long-term filling of the balloon 2703 also forces the prostate tissue that is not supported by the stent wire to expand, and the prostate tissue avoids growing and covering the stent wire after expansion. The balloon 2703 can also be filled intermittently, and the intermittent filling of the balloon 2703 also forces the prostate tissue that is not supported by the stent wire to expand, and the intermittent expansion of the prostate tissue can also avoid growing and covering the stent wire.

[0141] The above description is only a preferred specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can make equivalent replacements or changes according to the technical scheme and inventive concept of the present invention within the technical scope disclosed by the present invention, which should be covered by the protection scope of the present invention.

Claims

1. A prostate stent, characterized in that: include: The stent wire has an outwardly convex arc-shaped structure; An elastic isolation membrane sleeve, comprising a stent covering sleeve and an isolation membrane sheet, wherein the stent covering sleeve is sleeved on the stent wire, and the isolation membrane sheet is offset to one side relative to the stent wire in the stent covering sleeve, or the isolation membrane sheet corresponds to the position of the stent wire in the stent covering sleeve; A support area is provided on the prostate stent, and the stent wire is an arc-shaped, outwardly protruding structure, so that when the stent wire is compressed, the arc-shaped outward protrusion on it generates a supporting force on the prostate tissue; A step is provided between the port of the stent covering sleeve and the stent wire, and glue is infiltrated into the stent covering sleeve to bond the port of the stent covering sleeve to the stent wire. When the stent covering sleeve is fixed by glue bonding, glue is accumulated at the step to form an inclination and arc transition.

2. A prostate stent according to claim 1, characterized in that: The elastic isolation membrane sleeve is made of highly elastic polyurethane material, silica gel or rubber, and a corrosion treatment layer is arranged on the surface of the stent wire.

3. A method for manufacturing a prostate stent as claimed in claim 1 or 2, characterized in that: The following steps are involved: S1. Assemble multiple sections of positioning sleeves on the stent wire, and the material of the positioning sleeves is the same as that of the elastic isolation membrane sleeve; S2, placing the stent wire into the mold cavity of the film-covering mold, and positioning the stent wire using a positioning sleeve; S3, in the coating mold, the coating material covers the stent wire to form an elastic isolation membrane sleeve, and the coating material covers the circumference of the stent wire, so that the positioning sleeve and the coating material are integrated to form a stent covering sleeve of the elastic isolation membrane sleeve; S4, open the mold, take out the stent wire, and complete the coating.

4. The method for manufacturing a prostate stent according to claim 3, characterized in that: In step S1, the positioning sleeve is firstly put on the stent wire before riveting the two ends of the prostate stent.

5. The method for manufacturing a prostate stent according to claim 3, characterized in that: In step S1, the positioning sleeve is cut, and the cutting slit is arranged along the axial direction of the positioning sleeve. The positioning sleeve is stretched open at the cut part and then sleeved on the stent wire.

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

7. A method for manufacturing a prostate stent as claimed in claim 1 or 2, characterized in that: The following steps are involved: S1, placing a prostate stent in a mold cavity of a first coating mold, and fixing the stent wire of the prostate stent in the mold cavity using a stent positioning pile; S2, the coating material is formed into an elastic isolation membrane sleeve on the stent wire, the isolation membrane sheet of the elastic isolation membrane sleeve is provided with a plurality of positioning holes formed by the stent positioning piles, and the stent covering sleeve of the elastic isolation membrane sleeve is provided with a plurality of coating defects formed by the stent positioning piles, thereby achieving the first coating; S3, placing the prostate stent into the mold cavity of the second coating mold, and after the coating material is passed into the mold cavity of the second coating mold, the positioning holes and coating defects are filled to form a complete elastic isolation membrane sleeve, thereby achieving the second coating; S4. Open the mold, take out the prostate stent, and complete the coating.

8. A prostate stent, characterized in that: include: The stent wire has an outwardly convex arc-shaped structure; An annular covering film is fixedly mounted on the stent wire; Among them, the annular coating on the prostate stent is in a concave and relaxed state; The stent wire is an arc-shaped, outwardly protruding structure, so that when the stent wire is compressed, the arc-shaped outward protrusion on it generates a supporting force for the prostate tissue.

9. A prostate stent according to claim 8, characterized in that: The inner side of the membrane sheet of the annular coating is fitted to form a connection portion, and the annular coating completely covers the circumferential surface of the stent wire, or the outer surface of the stent wire is bonded to the inner wall of the annular coating, forming a partial fit and fixation between the stent wire surface and the annular coating.

10. A prostate stent, characterized in that: include: A stent body, on which a stent wire is arranged, wherein the stent wire is in an outwardly protruding arc-shaped structure; A balloon catheter, comprising a valve body, a medium introduction tube, a balloon and a guide rod, wherein the valve body is arranged at one end of the medium introduction tube, one end of the balloon is connected to the medium introduction tube, and the other end opposite thereto is connected to the guide rod; The stent body is provided with a first stent inner sleeve and a second stent inner sleeve, the medium introduction tube passes through the inner cavity of the first stent inner sleeve, the medium introduction tube and the first stent inner sleeve are clearance-matched, a first gap cavity is formed between the medium introduction tube and the inner wall of the first stent inner sleeve, the first gap cavity is used for passing urine, and the first balloon step is used for limiting the relative sliding between the medium introduction tube and the first stent inner sleeve; The guide rod passes through the inner cavity of the second stent inner sleeve and forms a clearance fit, the guide rod and the inner cavity of the second stent inner sleeve form a second clearance cavity, urine flows through the second clearance cavity, and the second balloon step is used to limit the relative sliding between the guide rod and the second stent inner sleeve; The balloon is confined within the lumen of the stent body in either a filled state or a non-filled state.

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