A urinary stent

Abstract

The purpose of this application is to provide a urinary stent, which includes a stent frame and a stent wire. The stent frame includes an integrally formed first stent frame and a second stent frame, with the first stent frame having a shoulder. The stent wire includes an integrally formed first stent wire portion and a second stent wire portion, with the first stent wire portion disposed on the surface of the first stent frame and the second stent wire portion disposed on the surface of the second stent frame. The urinary stent provided by this application has a large radial support force, can effectively withstand pressure, and has good folding performance, improving the device's adaptability to external pressure and its load-bearing limit. Furthermore, the stent wire of this urinary stent is provided with a wire hook, and the first stent frame has uniform grooves. By hooking the wire hook, the device can be easily removed directly from the body, improving the device's practicality and convenience.

Description

Technical Field

[0001] This application relates to a urinary stent. Background Technology

[0002] Current treatments for prostate cancer or benign prostatic hyperplasia (BPH) typically involve radical radiotherapy and prostatectomy. Radiotherapy damages surrounding healthy tissue, while prostatectomy completely removes the prostate, impacting the patient's daily life. Ablation techniques, on the other hand, can avoid damage to healthy tissue and do not require prostate removal, minimizing postoperative disruption. This method involves placing electrode needles around the lesion and applying an electric field to kill cancerous cells. However, this ablation method can cause localized edema in the ablation area, compressing the urethra that runs through the prostate and leading to urethral stricture and postoperative difficulty urinating. Summary of the Invention

[0003] One objective of this application is to provide a urinary stent.

[0004] According to one aspect of this application, a urinary stent is provided, the urinary stent comprising a stent frame and a stent wire.

[0005] The support frame includes an integrally formed first support frame and a second support frame, wherein the first support frame is provided with a shoulder.

[0006] The bracket winding includes an integrally formed first bracket winding part and a second bracket winding part, the first bracket winding part being disposed on the surface of the first bracket frame, and the second bracket winding part being disposed on the surface of the second bracket frame.

[0007] In some embodiments, the shoulder is provided on the upper part of the first support frame and is symmetrically arranged on both sides of the apex of the first support frame.

[0008] In some embodiments, the angle of the shoulder ranges from 150° to 175°.

[0009] In some embodiments, the end of the first support frame away from the second support frame is the first end of the first support frame, and the end closer to the second support frame is the second end of the first support frame. The area difference between the cross-sectional area of ​​the first end of the first support frame and the cross-sectional area of ​​the second end of the first support frame is less than or equal to a preset area difference threshold.

[0010] In some embodiments, the preset area difference threshold is 1% to 5% of the cross-sectional area of ​​the first end of the first support frame.

[0011] In some embodiments, one end of the second support frame closer to the first support frame is the first end of the second support frame, and the other end is the second end of the second support frame, wherein the cross-sectional area of ​​the first end of the second support frame is greater than the cross-sectional area of ​​the second end of the second support frame.

[0012] In some embodiments, the first support winding portion includes at least one spiral unit, the spiral unit including multiple winding wires that circumferentially surround the first support frame according to a preset lead, the multiple winding wires having the shape of multiple near-triangular waists, and the intersection of the multiple winding wires being the corner points of the multiple near-triangular waists.

[0013] In some embodiments, the windings distributed on both sides of the shoulder in the multi-segment windings are two shoulder-side windings, and the angle between the straight line or tangent of the two shoulder-side windings is between 100° and 140°.

[0014] In some embodiments, the angle between each of the multiple winding segments and the cross-section of the first support frame ranges from 20° to 40°.

[0015] In some embodiments, the preset lead ranges from 3 mm to 87 mm.

[0016] In some embodiments, the two shoulder-side windings are connected at the shoulder by an axial bend, and the corner of the axial bend coincides with the vertex of the corresponding shoulder.

[0017] In some embodiments, the second support winding section includes a plurality of U-shaped undulating units composed of two parallel windings and an arc-shaped winding connecting the two parallel windings. The axial angle between the straight direction of the parallel windings and the axial direction of the second support winding section is less than or equal to an axial angle threshold. The adjacent parallel windings in the plurality of U-shaped undulating units are connected by the arc-shaped winding.

[0018] In some embodiments, the axial included angle threshold is 5° to 10°.

[0019] In some embodiments, the parallel winding lengths of adjacent undulating units in the plurality of U-shaped undulating units of the second support winding section are different.

[0020] In some embodiments, the urinary stent further includes an ear loop, which is disposed on one side near the distal end of the second stent frame. The ear loop includes an ear loop frame and an ear loop winding wire, which is integrally formed with the stent winding wire and is disposed on the outer surface of the ear loop frame.

[0021] In some embodiments, the support winding comprises a single alloy wire with shape memory function.

[0022] In some embodiments, the diameter of the support wire ranges from 0.2 mm to 0.5 mm.

[0023] In some embodiments, the end of the wire wound around the ear is configured as a loop structure.

[0024] In some embodiments, the first support frame has a slot.

[0025] Compared with existing technologies, the urinary stent provided in this application effectively provides greater radial support to areas of edema that exert significant pressure on the urethra, improving the stent's load-bearing limit and exhibiting good elasticity, thus enhancing its adaptability to external pressure. Furthermore, the stent's winding wire has a ring-shaped structure at its end, and the stent frame has a groove. By hooking the ring-shaped structure and pulling it backward, the groove in the stent frame cracks and breaks, transforming the winding wire into a single metal wire. This allows for easy removal of the device from the body, improving its practicality and convenience. In addition, the urinary stent has a relatively simple structure, ensuring that it functions as a stent in cases of urethral stricture while allowing the patient to urinate normally, providing a better rehabilitation experience. Attached Figure Description

[0026] Other features, objects and advantages of the present application will become more apparent upon reading the detailed description of non-limiting embodiments made with reference to the following drawings:

[0027] Figure 1 A side view of a urinary stent according to one embodiment of this application is shown;

[0028] Figure 2 A perspective view of a urinary stent according to one embodiment of this application is shown;

[0029] Figure 3 This invention illustrates a needle placement method for an ablation technique according to an embodiment of this application;

[0030] Figure 4 An example cross-sectional view of a first support frame according to an embodiment of this application is shown;

[0031] Figure 5 An example diagram showing a cross-section of a first support frame according to another embodiment of this application;

[0032] Figure 6 This diagram shows a deformation analysis of the cross-section of a first support frame according to yet another embodiment of this application.

[0033] Figure 7 An example diagram of the second support wire winding portion according to an embodiment of this application is shown;

[0034] Figure 8 This diagram shows an example of the unfolded wire winding portion of the first support according to an embodiment of the present application;

[0035] Figure 9 An example diagram showing an axial bend angle according to an embodiment of this application is shown;

[0036] The same or similar reference numerals in the accompanying drawings represent the same or similar parts.

[0037] Figure Labels

[0038] 11 upper part

[0039] 12 lower part

[0040] 21 Ablation electrode needle

[0041] 22. Internal glands of the prostate

[0042] 23. Peripheral zone of the prostate

[0043] 100 Urinary stents

[0044] 101 Support Frame

[0045] 102 Ear hook frame

[0046] 103 Bracket Wire Winding

[0047] 109 ear hanging part

[0048] 120 First support winding section

[0049] 121 Second support winding section

[0050] 122 Connecting part

[0051] 123 Ear loops wrapped with silk

[0052] 124 Ring structure

[0053] 131 First support frame

[0054] 132 Second support frame

[0055] 110 First flow guide cavity

[0056] 112 First end of the first support frame

[0057] 113 The second end of the first support frame

[0058] 114 The first end of the second support frame

[0059] 115 The second end of the second support frame

[0060] 150 The apex of the first support frame

[0061] 160 Second flow guide cavity

[0062] 161 The first end of the ear-hanging frame

[0063] 162 The second end of the ear-hook frame

[0064] 1011 shoulder

[0065] 1012 The apex of the shoulder

[0066] 1201 Axial angle

[0067] 1203 First shoulder side winding

[0068] 1204 Second shoulder side winding Detailed Implementation

[0069] The present application will now be described in further detail with reference to the accompanying drawings.

[0070] In the description of this application, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," and "counterclockwise," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0071] Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of this application, "a plurality of" means two or more, unless otherwise explicitly specified.

[0072] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0073] In this application, unless otherwise expressly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature being directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature being directly above or diagonally above the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0074] Current treatment techniques for prostate cancer or benign prostatic hyperplasia (BPH) typically involve radical radiotherapy and prostatectomy. Radiotherapy can damage surrounding healthy tissue, while prostatectomy completely removes the prostate, impacting the patient's daily life. To address these drawbacks, ablation techniques offer a treatment option that avoids damage to healthy tissue and eliminates the need for prostate removal, minimizing postoperative disruption to the patient's life. During treatment, ablation electrode needles 21 are typically placed at... Figure 3 The image shows the interior of the prostate gland 22. An electric field is applied to kill prostatic hyperplasia cells or cancer cells, thus achieving a therapeutic effect. However, this ablation method can cause localized edema in the ablation area (needle placement area), compressing the upper urethra and leading to urethral stricture. The implanted urinary stent experiences significant pressure in this area. For example... Figure 3-5 As shown, after the urinary stent is implanted in the body, the side closer to the prostate gland 22 is called the upper part 11, and the side closer to the prostate peripheral zone 23 is called the lower part 12. The first stent frame 131 has a protrusion at the position closest to the prostate gland 22, which we call the apex (as shown in position 150 in the attached figure).

[0075] refer to Figure 1 , Figure 2This application illustrates a urinary stent 100, which includes a stent frame 101 and a stent winding wire 103. The stent frame 101 includes an integrally formed first stent frame 131 and a second stent frame 132, and the first stent frame 131 is provided with a shoulder 1011. The stent winding wire 103 includes an integrally formed first stent winding wire portion 120 and a second stent winding wire portion 121, the first stent winding wire portion 120 being disposed on the surface of the first stent frame 131, and the second stent winding wire portion 121 being disposed on the surface of the second stent frame 132. For example, the first support frame 131 and the second support frame 132 are integrally formed, and a first flow guiding cavity 110 is provided inside. Specifically, the integrally formed support frame 101 is a frame with openings on both sides, and the first flow guiding cavity 110 is provided inside the frame. The two ends of the first support frame 131 are the first end 112 of the first support frame 131 and the second end 115 of the second support frame 132. The first flow guiding cavity 110 includes a cavity extending from the first end 112 to the second end 113. The first support frame 101 is provided with one or more shoulders 1011. In some embodiments, the shoulders (1011) are provided on the upper part of the first support frame 131, and can be symmetrically arranged on both sides of the apex 150 of the first support frame 131, or asymmetrically arranged. For example, the top of the first support frame 101 is provided with an outward-facing vertex 150. In some cases, in order to conform to the shape of the urethra, a recess is provided at the lower part 12 on the opposite side of the vertex 150, and the orientation of the vertex 150 protrusion is the same as the orientation of the recess. The first support frame 131 is provided with one or more shoulders 1011 on both sides of the protrusion. For example, when there is only one shoulder 1011, it can be provided on one side of the protrusion, and the angle range of the shoulder is 150° to 175°; when there are multiple shoulders 1011, they can be provided on both sides of the protrusion. In some cases, the multiple shoulders 1011 are symmetrically distributed on both sides of the protrusion, such as the multiple shoulders 1011 being symmetrical about the vertical section of the first support frame 131, where the vertical section is the plane formed by the connection between the vertex protrusion and the bottom recess, and the angle range of the shoulders is 150° to 175°.

[0076] In some embodiments, the end of the first support frame 131 furthest from the second support frame 132 is the first end 112 of the first support frame 131, and the end closest to the second support frame 132 is the second end 113 of the first support frame 131. The area difference between the cross-sectional area of ​​the first end 112 and the cross-sectional area of ​​the second end 113 of the first support frame 131 is less than or equal to a preset area difference threshold. For example, in order to ensure unobstructed flow of fluid in the patient's urethra while maintaining the basic support structure of the first drainage cavity, the cross-sectional shape of the first support frame 101 remains essentially unchanged. In other words, the area difference between the cross-sectional area of ​​the first end 112 and the cross-sectional area of ​​the second end 113 of the first support frame 131 is less than or equal to the preset area difference threshold. The value of this preset area difference threshold can be in the range of 1% to 5% of the cross-sectional area of ​​the first end 112 of the first support frame. For example, the cross-sectional area of ​​the first end 112 and the cross-sectional area of ​​the second end 113 of the first support frame 131 are approximately the same. In some cases, fluid (e.g., bodily fluids or urine) within the patient's urethra can flow in from the first end 112 of the first stent frame 131, pass through the first drainage cavity 110, and exit from the second end 115 of the second stent frame 132. In some embodiments, the cross-sectional shape of the first stent frame 131 includes a heart shape. For example, the cross-sectional shape of the first stent frame 131 composed of one or more shoulders 1011 is similar to a heart shape, with the one or more shoulders 1011 distributed on both sides of the pointed portion of the heart shape and / or the center line of the heart shape (e.g., the line connecting the pointed portion and the recessed portion of the heart shape) and close to the pointed portion, wherein the shoulders 1011 distributed on both sides of the center line of the heart shape are symmetrical based on the center line of the heart-shaped cross-section. Of course, those skilled in the art should understand that the above-described heart-shaped cross-section is merely an example, and other existing or future heart-shaped cross-sections containing multiple shoulders that are applicable to this application should also be included within the scope of protection of this application, and are hereby incorporated by reference.

[0077] In some embodiments, the second support frame 132 has a first end 114 near the first support frame 131 and a second end 115 near the first support frame 131. The cross-sectional area of ​​the first end 114 is larger than that of the second end 115. For example, the second support frame 132 is used to narrow the diameter of the outlet side of the first support frame 131. The second support frame 132 is connected to the first support frame 131, and the cross-section of the second end 113 of the first support frame 131 is connected to the cross-section of the first end 114 of the second support frame 132, and their cross-sectional areas are the same. The second support frame 132 can be configured as a near-conical frustum-shaped structure. Its diameter at its first end 114 is the same as that at its second end 113 of the first support frame 131, and its diameter gradually decreases as it extends towards its second end 115. Correspondingly, the cross-sectional area of ​​the first end 114 of the second support frame 132 is larger than the cross-sectional area of ​​its second end 115. The heart-shaped cross-sectional shape of the second support frame 132 gradually changes to a circle, pentagon, or other shapes that conform to the physiological characteristics of the patient's urethra as the diameter decreases. In some embodiments, the support frame 101 is placed on the side of the corresponding urethral sphincter near the bladder. (Reference) Figure 6 The diagram shows the deformation analysis of three cross-sections caused by uniformly distributed pressure. Figure 6 a shows the deformation analysis diagram corresponding to commonly used cross-sections. Figure 6 b and Figure 6 c respectively shows the aforementioned Figure 4 , Figure 5 The deformation analysis diagram corresponds to a heart-shaped cross-section containing multiple shoulders. Here, by simultaneously applying the same uniformly distributed pressure (e.g., 0.1 MPa), the stress-bearing area of ​​each cross-section is the same. Using Dassault Systèmes static stress simulation analysis, the maximum deformation result can be obtained, as shown in the deformation analysis diagram. The value corresponding to each arrow in the analysis diagram indicates the amount of deformation at the location indicated by the arrow. By comparing the corresponding deformation trends, the deformation can be determined... Figure 4 , Figure 5 The interface shown exhibits a significantly reduced deformation under the same stress conditions compared to commonly used cross-sections. This is because the actual force acting on the support frame is not constant. Figure 6 The figures shown only represent the deformation trend of the corresponding cross-sectional shape and do not represent the actual deformation of the stent body after implantation in the patient. Figure 6 The comparison results show that the structures of the three cross-sections of the support are different. Setting one or more protruding shoulders can provide better radial support force for the support frame, resulting in smaller deformation.

[0078] In some embodiments, the support frame (e.g., the first support frame 131, the second support frame 132, and / or the ear loop 102) is made of, but is not limited to, one or a combination of polyurethane, polyester, polytetrafluoroethylene, or expanded polytetrafluoroethylene, and the thickness of the support frame is between 0.05 mm and 0.8 mm. In some embodiments, the length and diameter of the support frame can be specifically set according to a certain proportion and in combination with the user's own physiological parameters, for example, the main body length of the frame is 40 mm, the corresponding closing length is 9 mm, and the ear loop length is 14 mm, etc.

[0079] For example, the support wire 103 includes an integrally formed first support wire portion 120 and a second support wire portion 121. The first support wire portion 120 is spirally arranged around the outer surface of the first support frame 131, and the second support wire portion is arranged around the outer surface of the second support frame 132. In some embodiments, the support wire 103 includes a single alloy wire with shape memory function. Specifically, the support wire 103 is made of a material that can bend and maintain its shape, such as a superelastic nickel-titanium alloy wire. In some embodiments, the diameter of the support wire 103 is between 0.2 mm and 0.5 mm. In some embodiments, the first support wire portion 120 includes at least one spiral unit, the spiral unit including multiple wire segments that circumferentially wrap around the first support frame according to a preset lead. The multiple wire segments are shaped like multiple near-triangular waists, and the intersection of the multiple wire segments is the corner point of the multiple near-triangular waists. For example, this solution employs a monofilament winding method, using a material that bends and maintains its shape to fit the aforementioned stent frame, thereby providing corresponding pressure-bearing and deformation capabilities at different locations of the urinary stent. Specifically, the stent winding 103 includes a first stent winding portion 120 extending circumferentially around the outer surface of the first stent frame 131 in a spiral shape. The winding of the first stent winding portion 120 extends circumferentially from the first end 112 to the second end 113, spiraling around a spiral unit for at least one cycle during the extension process. The spiral unit includes multiple winding segments that circumferentially wrap around the first stent frame 131 according to a preset lead. The shapes of the multiple winding segments are multiple near-triangular, and the intersection points of the multiple winding segments are the corner points of the multiple near-triangular. For example, the most rigid winding method for the first support wire winding section 120 is when each turn of wire adheres to the previous turn (similar to a solenoid). However, this method produces the most rigid support, but also makes shrinkage difficult. Therefore, it is necessary to control the lead of each turn of the winding. Increasing the lead (i.e., a larger interval between each turn) will reduce the support force of the support, while decreasing the lead (i.e., a smaller interval between each turn) will increase the support force, but shrinkage will be difficult. In some embodiments, the first support wire winding section 120 consists of one or more helical units, each helical unit including multiple segments of wire that circumferentially wrap around the first support frame according to a preset lead. For example, when the first support wire winding section 120 wraps around the first support frame 131 in a helical manner, since the diameter of the first support frame 131 remains essentially constant, one turn of wire corresponding to the outer surface of the first support frame 131 can be taken as a helical unit. The lead generally refers to the axial distance between adjacent corresponding points on the helically wound support wire. This lead can also be used to indicate the straight-line distance between the start and end points in the axial direction during a helical cycle. In some cases, refer to Figure 8The heart-shaped cross-section of the first support frame 132 and the multi-segment winding of the spiral unit can be approximately regarded as multiple near-isosceles triangles.

[0080] In some embodiments, the windings distributed on both sides of the shoulder 1011 in the multi-segment windings are two shoulder-side windings (e.g. Figure 9 The two sections of the winding wire shown are a first shoulder-side winding wire 1203 and a second shoulder-side winding wire 1204. The angle between the straight line or tangent of the two shoulder-side winding wires is between 100° and 140°, for example, 120°. For example, the convex shoulder 1011 is distributed on both sides of the vertex 150, and each convex shoulder 1011 has two winding wires on both sides. We consider the winding wires distributed on both sides of the convex shoulder as two shoulder-side winding wires. The two shoulder-side winding wires are connected by a curved arc, which can form a good support effect on the working area. The angle between the straight line or tangent of the two shoulder-side winding wires is between 100° and 140°, which can form a good support force while providing good support space. Of course, the specific values ​​mentioned above can be adjusted according to the shape and length of the patient's physiological structure.

[0081] In some embodiments, the angle between each of the multiple winding segments and the cross-section of the first support frame 131 ranges from 20° to 40°. For example, the cross-section of the first support frame 131 refers to the section perpendicular to the central axis of the first support frame 131. Each winding segment achieves a circumferential extension while extending from the first end 112 to the second segment 113 in a spiral winding effect by bending at a certain angle. The angle between each of the multiple winding segments and the cross-section of the first support frame 131 ranges from 20° to 40°. Figure 8 Angle α is shown in the figure.

[0082] In some embodiments, the preset lead value ranges from 3 mm to 87 mm. For example, the perimeter L of the cross-section of the first support frame 131 is typically between 20 and 50 mm. If the corresponding lead angle θ is determined, we can determine the axial distance of a helical unit in the axial direction, which is the corresponding lead. Here, the corresponding lead angle θ ranges from 10° to 60°, so we can determine that the preset lead value ranges from 3 mm to 87 mm.

[0083] In addition, refer to Figure 8The heart-shaped cross-section of the first support frame 131, and the support winding wire 103 corresponding to one spiral unit can be approximately regarded as multiple near-isosceles triangles. The near-triangular metal wire is wound around the cross-section of the first support frame 131 with a fixed lead θ. Assuming the perimeter of the cross-section is L (e.g., between 20 and 50 mm), the winding method of the metal wire is approximately multiple isosceles triangles, the number of triangles in one loop of the frame body 131 is T (e.g., between 2 and 5), and the base angle of the triangle is α, then the following data can be calculated using the aforementioned data:

[0084] The length of the base of each triangle is L / cosθ·T;

[0085] The side length of each triangle is L / 2T·cosθ·cosα;

[0086] The height of each triangle is h = L·tanα / 2T·cosθ.

[0087] For example, if the lead angle is 30°, corresponding to a perimeter L of 30mm, and there are 3 isosceles triangles with a base angle of 30°, then the base length of the triangle can be calculated to be 11.55mm (approximately to two decimal places), the side length to be 6.67mm, and the height to be 3.33mm, etc. Therefore, the length of the helical wire within the helical cycle can be determined, which is the sum of the lengths of the two legs of the multiple isosceles triangles, etc. Of course, those skilled in the art should understand that the above-described wire length calculation process is merely an example, and other existing or future wire length calculation processes that are applicable to this application should also be included within the scope of protection of this application, and are hereby incorporated by reference.

[0088] In some embodiments, the two shoulder-side windings (e.g.) Figure 9 The two sections of wire shown (first shoulder-side wire 1203 and second shoulder-side wire 1204) are connected at the shoulder 1011 by an axial bend 1201, the corner of which is abutted against the vertex 1012 of the corresponding shoulder 1011. For example, see reference. Figure 9 The winding method of the wire also affects the folding performance of the bracket. A winding method without any variation has the worst folding performance; after compression, it deforms and cannot return to its original size. Designing the winding method to... Figure 9The method shown allows the stent to deform at the bend point of the surface wire when subjected to compressive force, changing the stent from an expanded state to a compressed state. When the external compressive force is removed, the compressed stent will return to its expanded state at the bend point due to the elasticity of the metal itself. This characteristic enables both the contraction and delivery of the urinary stent and the expansion of the stent, thus ensuring that the wire has strong stent strength while also possessing a certain degree of deformation capability. The two shoulder-side wires are connected at the shoulder 1011 by axial bends 1201, and the corner point of each of the one or more axial bends 1201 is abutted against the vertex of one or more shoulders 1011. For example, the vertex 1012 of the shoulder 1011 refers to the midpoint of the arcuate structure of the arcuate portion of the shoulder. By setting the corner point of each axial bend 1201 at the midpoint corresponding to the arcuate portion of the shoulder 1011 among multiple shoulders, external compression is prevented while ensuring support strength. The shoulder 1011 and the first stent winding part 120 are designed to effectively target the location of the patient's site that exerts greater pressure on the urethra, giving the stent greater radial support force, providing high support strength for the stent, and improving the device's adaptability to external pressure and its load-bearing limit.

[0089] refer to Figure 7In some embodiments, the second support winding section 121 includes a plurality of U-shaped undulating units 1211, each consisting of two parallel winding sections 1212 and an arc-shaped winding section 1213 connecting the two parallel winding sections. The axial angle between the straight direction of the parallel winding section 1212 and the axial direction of the second support winding section 121 is less than or equal to a threshold axial angle. Adjacent parallel winding sections 1212 in adjacent U-shaped undulating units 1211 are connected by arc-shaped winding sections 1214. For example, the second support winding section 121 surrounding the outer surface of the second support frame 132 has the same or similar winding method as the ear winding section 123, both being wound in an undulating wave pattern to provide them with strong deformation capability. Here, the second support winding section 121 includes a plurality of U-shaped undulating units 1211, each consisting of two parallel winding sections 1212 and an arc-shaped winding section 1213 connecting the two parallel winding sections. In some embodiments, the U-shaped undulating unit 1211 is formed by connecting two parallel winding wires 1212 and an arc-shaped winding wire 1213 on the same side of the parallel winding wires 1212. The opening direction of the U-shaped undulating unit points from the first end 114 of the second support frame 132 to the second end 115. Since the diameter of the corresponding second support frame 132 gradually decreases as it extends from the first end 114 to the second end 115, the opening direction of the corresponding U-shaped undulating unit is not parallel to the axial direction, but has a small axial angle, which is less than or equal to an axial angle threshold. This axial angle threshold is taken in the range of 5° to 10°. In other words, the axial angle between the straight direction of the corresponding parallel winding wire 1212 and the axial direction of the second support winding part 121 is less than or equal to the axial angle threshold. In the plurality of U-shaped undulating units 1211, adjacent parallel winding wires 1212 are connected on the opening side by an arc-shaped winding wire 1214. After the second support wire winding portion 121 has been wound around the outer surface of the second support frame 132 once by multiple U-shaped undulation units 1211, the second support wire winding portion 121 extends a certain length in the fluid flow direction (e.g., the length of one waveform amplitude) and continues to circumferentially wrap around the outer surface of the second support frame 132 with U-shaped undulation units 1211, until the remaining space on the outer surface of the support frame no longer meets the amplitude requirements of the undulating wave (e.g., the straight-line distance between the corresponding flow outlet and the current wire winding position is less than one amplitude of the undulating wave). The amplitude of the waveform of each unit in the multiple U-shaped undulation units 1211 can be the same or different. For example, in some embodiments, the parallel wire winding lengths of adjacent undulation units 1211 in the multiple U-shaped undulation units of the second support wire winding portion 121 are different.In some embodiments, a gap exists between the second stent frame 132 and the ear-mounted frame 102, thereby allowing the patient to maintain urinary control while securing the urinary stent. For example, the sphincter function can still be preserved, as the stent wires on both sides of the sphincter have strong deformation capacity and relatively weak stiffness, allowing the sphincter to still function normally. In some embodiments, the distance of this gap is typically 13-16 mm. The supporting stiffness of the second stent frame 132 and the second stent wire portion 121 is relatively weak, and their tapered positioning surfaces can be used for urethral positioning.

[0090] In some embodiments, the urinary stent 100 further includes an ear loop 109, which includes an ear loop frame 102 and an ear loop winding wire 123. The ear loop frame 102 is disposed on one side near the second end 115 of the second stent frame 132, and the ear loop frame 102 is not in direct contact with the second stent frame 132. The ear loop winding wire 123 is integrally formed with the stent winding wire 103 and is disposed on the outer surface of the ear loop frame 102. For example, the urinary stent 100 also includes a loop portion 109 for fixing and preventing slippage of the urinary stent. The loop portion frame 102 of the loop portion has a second drainage cavity 160 inside. The second drainage cavity 160 includes a cavity extending from a first end 161 of the loop portion 109 near the stent frame 101 to a corresponding second end 162. The loop portion winding wire 123 of the loop portion 109 is integrally formed with the stent winding wire 103, and may be connected by a corresponding connecting part 122. The loop portion 109 is used to fix the urinary stent in the patient's urethra, preventing the urinary device from slipping into the bladder due to prostate movement or urine transport. The pressure-bearing and deformation requirements of the ear loop frame 102 are similar to those of the aforementioned second support frame 132. The deformation requirement of the second drainage inlet near the sphincter is greater. Therefore, the ear loop frame 102 can be configured as a column with the same diameter as the second support frame 132 or a frustum-like shape with a gradually increasing diameter. Different radial support forces are formed based on different external wire winding structures, providing stronger deformation capability for the ear loop. In some embodiments, the diameter of the cross-section of the ear loop frame 102 gradually increases as it extends from the first end 161 to the second end 162. In some embodiments, corresponding to the change in diameter of the ear loop frame 102, the cross-sectional shape of the ear loop frame 102 also changes accordingly. For example, it gradually returns to a cross-section with a larger diameter from the aforementioned smaller diameter shape. The larger diameter cross-section can be the same cross-sectional shape as the support body 101, or it can be another cross-section with a larger diameter, such as a larger cross-section obtained by increasing the diameter while maintaining the shape of a smaller cross-section. Additionally, smaller diameter shapes include circles, pentagons, or other shapes that conform to the physiological characteristics of the patient's urethra. Here, the winding method of the ear loop 123 is the same as or similar to the winding method of the second bracket 121.

[0091] In some embodiments, the end of the loop wire 123, i.e., the end furthest from the connecting part 122, is configured as a loop structure 124. Its sharp end is located inside the loop structure 124, which prevents the tip of the wire from damaging human tissue. Furthermore, it allows doctors to more easily clamp and pull the loop structure 124 outwards using a device, thus facilitating the removal of the urinary stent. For example, to facilitate removal of the urinary stent after patient recovery, the loop wire 124 automatically wraps around the end of the loop wire 102 to form an arc or circle, creating a loop structure 124. Specifically, a small loop is formed at the end of the loop wire 123 to create a corresponding loop structure 124. In some embodiments, the stent frame has multiple slots, which can be circular, polygonal, serrated, or other shapes. For example, to facilitate easy removal of the urinary stent and minimize patient discomfort during removal, uniformly spaced slots are provided around the stent frame 101. These slots are designed to create cracks and damage the stent frame (e.g., the ear-mounted frame 102, the first stent frame 131, and the second stent frame 132) when subjected to external tension. This allows the urinary stent to become a single metal wire under external tension, making it easy to remove from the patient's body. For example, the slots can be uniformly spaced small holes spirally surrounding the stent frame, or uniformly spaced small holes radially surrounding the stent frame at intervals. In some cases, the ear-mounted frame 102 also has the same or similar slots. Of course, those skilled in the art should understand that the above slots are merely examples, and other existing or future slots that are applicable to this application should also be included within the scope of protection of this application, and are hereby incorporated by reference.

[0092] It will be apparent to those skilled in the art that this application is not limited to the details of the exemplary embodiments described above, and that this application can be implemented in other specific forms without departing from the spirit or essential characteristics of this application. Therefore, the embodiments should be considered exemplary and non-limiting in all respects, and the scope of this application is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be embraced within this application. No reference numerals in the claims should be construed as limiting the scope of the claims. Furthermore, it is clear that the word "comprising" does not exclude other units or steps, and the singular does not exclude the plural. Multiple units or devices recited in the apparatus claims may also be implemented by a single unit or device in software or hardware. The terms "first," "second," etc., are used to indicate names and do not indicate any particular order.

Claims

1. A urinary stent, characterized in that, The urinary stent includes a stent frame and a stent wire. The support frame includes an integrally formed first support frame and a second support frame. The first support frame is provided with a shoulder, and the top of the first support frame is provided with an outward-facing vertex. One or more shoulders are provided on both sides of the vertex, and the angle range of the shoulders is 150° to 175°. The bracket winding includes an integrally formed first bracket winding part and a second bracket winding part, the first bracket winding part being disposed on the surface of the first bracket frame, and the second bracket winding part being disposed on the surface of the second bracket frame.

2. The urinary stent according to claim 1, characterized in that, The shoulder is provided on the upper part of the first support frame and is symmetrically arranged on both sides of the apex of the first support frame.

3. The urinary stent according to claim 1, characterized in that, The end of the first support frame furthest from the second support frame is the first end of the first support frame, and the end closest to the second support frame is the second end of the first support frame. The area difference between the cross-sectional area of ​​the first end of the first support frame and the cross-sectional area of ​​the second end of the first support frame is less than or equal to a preset area difference threshold.

4. The urinary stent according to claim 1, characterized in that, The end of the second support frame closest to the first support frame is the first end of the second support frame, and the other end is the second end of the second support frame. The cross-sectional area of ​​the first end of the second support frame is greater than the cross-sectional area of ​​the second end of the second support frame.

5. The urinary stent according to claim 1, characterized in that, The first support wire winding section includes at least one spiral unit. The spiral unit includes multiple wire segments that circumferentially surround the first support frame according to a preset lead. The multiple wire segments are in the shape of multiple near-triangles, and the intersection of the multiple wire segments is the corner point of the multiple near-triangles.

6. The urinary stent according to claim 5, characterized in that, Among the multiple winding sections, the winding sections distributed on both sides of the shoulder are two shoulder-side winding sections, and the angle between the straight line or tangent of the two shoulder-side winding sections is between 100° and 140°.

7. The urinary stent according to claim 5 or 6, characterized in that, The angle between each of the multiple winding segments and the cross-section of the first support frame ranges from 20° to 40°.

8. The urinary stent according to claim 5 or 6, characterized in that, The preset lead value ranges from 3 mm to 87 mm.

9. The urinary stent according to claim 6, characterized in that, The two shoulder-side windings are connected at the shoulder by an axial bend, and the corner of the axial bend is in contact with the vertex of the corresponding shoulder.

10. The urinary stent according to claim 1, characterized in that, The second support winding section includes multiple U-shaped undulating units composed of two parallel windings and an arc-shaped winding connecting the two parallel windings. The axial angle between the straight direction of the parallel windings and the axial direction of the second support winding section is less than or equal to the axial angle threshold. The adjacent parallel windings in the multiple U-shaped undulating units are connected by the arc-shaped winding.

11. The urinary stent according to claim 10, characterized in that, In the second support winding section, the parallel winding lengths of adjacent U-shaped undulating units are different.

12. The urinary stent according to claim 1, characterized in that, The urinary stent also includes a hanging ear portion, which is located on one side near the distal end of the second stent frame. The hanging ear portion includes a hanging ear portion frame and a hanging ear portion winding wire. The hanging ear portion winding wire is integrally formed with the stent winding wire and is located on the outer surface of the hanging ear portion frame.

13. The urinary stent according to claim 1, characterized in that, The support winding is a single alloy wire with shape memory function.

14. The urinary stent according to claim 1, characterized in that, The diameter of the wire wound around the support ranges from 0.2 mm to 0.5 mm.

15. The urinary stent according to claim 12, characterized in that, The end of the wire wound around the ear is designed as a loop.

16. The urinary stent according to any one of claims 1 to 6, 9 to 15, characterized in that, The support frame has slots.

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