Spiral embedded metal wire composite ureteral stent

By using the method of spiral embedding of nickel-titanium alloy wire in the ureteral stent, the problem that the existing stent cannot take into account both the support function and biocompatibility, and the effect of providing sufficient support in severely narrow areas and having good biocompatibility is achieved.

CN119970316AActive Publication Date: 2025-05-13COPPER MEDICAL TECH CO LTD
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Patent Information

Application Number
CN202510085533.2
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-01-20
Publication Date
2025-05-13
Estimated Expiration
2045-01-20

AI Technical Summary

Technical Problem

Existing ureteral stents fail to balance support and biocompatibility, resulting in insufficient support in the face of severe ureteral stenosis and may cause discomfort or complications to the patient.

Method used

A spiral embedded metal wire composite ureter support is used, and its main body is made of polymer elastic material and nickel-titanium alloy wire is embedded. The metal wire extends along the spiral support structure to form a structure similar to a spring, enhancing the support function, and ensuring that the support can restore the spiral-like tight arrangement after being placed.

Benefits of technology

It provides the necessary support in severely narrow areas, and has good biocompatibility to avoid discomfort or complications to the patient, ensuring the stability and user experience of the stent.

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Abstract

The spiral embedded metal wire composite ureteral stent comprises a main body and a metal wire embedded in the main body, and the main body is made of a macromolecular elastic material; the body comprises a supporting pipe and fixing pipes located at the two ends of the supporting pipe, and the supporting pipe extends along a first spiral curve to form a spiral supporting structure. According to the spiral embedded metal wire composite ureteral stent, the macromolecular elastic material serves as a main body, good biocompatibility is achieved, and discomfort or other complications caused to a patient are avoided. Due to the fact that the supporting pipe extending along the first spiral curve forms a supporting structure, a necessary supporting effect can be provided at a seriously narrow part. The metal wire also extends along the first spiral curve in the spiral supporting structure to form a structure similar to a spring, so that the supporting effect is enhanced, the spiral tight arrangement of the spiral supporting structure can be recovered in time after the spiral supporting structure is placed into the ureter of a patient, and the spiral embedded metal wire composite ureter stent has enough supporting force and can be used for supporting the ureter of the patient. And the biological compatibility is good.
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Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a spiral embedded metal wire composite ureteral stent. Background Art Ureteral stenosis is a common urinary system disease, usually caused by a variety of reasons, such as congenital malformations, trauma, surgical sequelae or inflammation. This disease can cause obstruction of urine flow between the kidney and bladder, leading to hydronephrosis and even renal failure. In order to solve this problem, ureteral stent placement is widely used in clinical practice to relieve symptoms and improve the quality of life of patients.

[0002] However, the materials of existing ureteral stents mainly include two categories: polymer materials and metal materials, but each of them has some obvious shortcomings: although polymer materials have good biocompatibility and low cost advantages, due to their relatively soft properties, they may not be able to provide sufficient support to keep the urethra open when facing more severe ureteral stenosis, especially malignant stenosis. Although metal materials have strong mechanical strength and can provide necessary support for severe stenosis, they also have problems with local tissue irritation caused by excessive hardness and poor biocompatibility. Long-term use may cause discomfort or other complications to patients. In other words, existing ureteral stents cannot take into account both support and biocompatibility, which is not conducive to product promotion and application. Summary of the invention

[0003] The embodiment of the present invention provides a spiral embedded metal wire composite ureteral stent, which takes into account both the supporting function and biocompatibility.

[0004] Specifically, the present invention provides a spiral embedded metal wire composite ureteral stent, comprising a main body and a metal wire embedded in the main body, wherein the main body is made of a polymer elastic material; The main body comprises a support tube and fixing tubes located at both ends of the support tube, the support tube extends along a first spiral curve to form a spiral support structure; the fixing tubes are used to be arranged in the renal pelvis and bladder of the patient respectively.

[0005] Optionally, the pitch of the spiral support structure is less than 1 mm.

[0006] Optionally, the length of the spiral support structure is 1 to 20 cm; the diameter of the spiral support structure is 6 mm to 10 mm.

[0007] Optionally, there are multiple support tubes, and the multiple support tubes are arranged at intervals along the axial direction of the spiral support structure; each support tube forms a spiral support structure.

[0008] Optionally, a first cavity and a second cavity are provided on the main body, the first cavity extends along the length direction of the main body, and the internal spaces of the support tube and the fixed tube are both part of the first cavity; the second cavity is spaced apart from the first cavity, and the metal wire is provided in the second cavity.

[0009] Optionally, the second cavity extends along the length of the main body; or, the second cavity is arranged axially around the first cavity and extends along a second spiral curve, and the second spiral curve surrounds the first cavity.

[0010] Optionally, there are multiple second cavities, and the multiple second cavities are arranged at intervals; the metal wires are arranged in a one-to-one correspondence with the second cavities.

[0011] Optionally, a plurality of side holes are provided on the main body, and the plurality of side holes are arranged at intervals along the length direction of the main body; and the side holes are connected to the first cavity.

[0012] Optionally, the material of the metal wire is nickel-titanium alloy; and / or the material of the main body is one of polyurethane, polyolefin, and silicone rubber.

[0013] Optionally, the fixing tube has a fixing end and a connecting end, the connecting end being connected to the supporting tube; the fixing end extends along a second spiral curve to form a curled fixing structure, and the number of turns n of the curled fixing structure satisfies: 0.5<n<1.5.

[0014] The beneficial effects of the present invention are: In the spirally embedded metal wire composite ureteral stent provided by the present invention, a polymer elastic material is used as the main body of the spirally embedded metal wire composite ureteral stent, which has good biocompatibility and avoids discomfort or other complications to patients; since the support tube extending along the first spiral curve forms a support structure, it can provide necessary support in severe stenosis areas; the metal wire also extends along the first spiral curve in the spiral support structure to form a spring-like structure, which not only enhances the support effect, but also ensures that the spiral support structure can promptly restore the spiral tight arrangement after being inserted into the patient's ureter, so that the spirally embedded metal wire composite ureteral stent has both sufficient supporting force and good biocompatibility. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings required for use in the description of the embodiments of the present invention will be briefly introduced below. Obviously, the accompanying drawings in the following description are only some embodiments of the present invention. For ordinary technicians in this field, other accompanying drawings can be obtained based on these accompanying drawings without paying creative labor.

[0016] Figure 1 is a schematic structural diagram of a spirally embedded metal wire composite ureteral stent in one embodiment of the present invention; Figure 2 is a schematic cross-sectional view of a spirally embedded metal wire composite ureteral stent in one embodiment of the present invention; Figure 3 It is a schematic partial structural diagram of a spirally embedded metal wire composite ureteral stent in one embodiment of the present invention.

[0017] In the figure: 100, main body, 101, first cavity, 102, second cavity, 103, side hole, 110, support tube, 120, fixing tube, 121, fixing end, 122, connecting end, 200, metal wire. DETAILED DESCRIPTION

[0018] In order to make the technical problems, technical solutions and beneficial effects solved by the present invention more clearly understood, the present invention is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0019] In the description of the present invention, it should be understood that the terms "longitudinal", "radial", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In the description of the present invention, unless otherwise specified, "plurality" means two or more.

[0020] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" 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 mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0021] Figure 1 FIG. 1 is a schematic structural diagram of a spirally embedded metal wire composite ureteral stent according to an embodiment of the present invention. Figure 1 As shown, and refer to Figures 2 to 3An embodiment of the present invention provides a spiral embedded metal wire composite ureteral stent, including a main body 100 and a metal wire 200 embedded in the main body 100, wherein the main body 100 is made of a polymer elastic material; the main body 100 includes a support tube 110 and fixed tubes 120 located at both ends of the support tube 110, wherein the support tube 110 extends along a first spiral curve to form a spiral support structure; the fixed tube 120 is used to be respectively arranged in the renal pelvis and the bladder of the patient.

[0022] In the embodiment of the present invention, the main body 100 of the spiral embedded metal wire composite ureteral stent made of polymer elastic material has good biocompatibility, avoiding discomfort or other complications to the patient; since the support tube 110 extending along the first spiral curve forms a support structure, it can provide necessary support in the severe stenosis area; the metal wire 200 also extends along the first spiral curve in the spiral support structure to form a spring-like structure, which can not only enhance the support effect to resist the compression of the ureter by malignant or benign tumors, but also ensure that the spiral support structure can restore the spiral tight arrangement in time after being inserted into the patient's ureter, so that the spiral embedded metal wire composite ureteral stent has both sufficient support force and good biocompatibility. In addition, the metal wire 200 is wrapped with a polymer elastic material to avoid metal precipitation of the metal wire and avoid affecting the patient.

[0023] When in use, the fixed tube 120 at both ends is located in the renal pelvis and bladder of the patient respectively, so that the spiral support structure is located in the ureter, so that the patient's urine can flow into the bladder through the internal space of the spiral support structure.

[0024] It should be noted that the spiral embedded metal wire composite ureteral stent of the present invention is an improvement on the ureteral stent in the prior art. That is, the embodiment of the present invention provides a ureteral stent, including a main body 100 and a metal wire 200 embedded in the main body 100, the main body 100 is made of a polymer elastic material; the main body 100 includes a support tube 110 and fixed tubes 120 located at both ends of the support tube 110, the support tube 110 extends along a first spiral curve to form a spiral support structure; the fixed tube 120 is used to be respectively set in the renal pelvis and bladder of the patient.

[0025] In one embodiment of the present invention, the pitch of the spiral support structure is less than 1 mm, so that any two adjacent circles of the spiral support structure are closely arranged to hinder the ureteral intima from growing inward. Preferably, the pitch of the spiral support structure is less than 0.4 mm.

[0026] In one embodiment of the present invention, the length of the spiral support structure is 1-20 cm; the diameter of the spiral support structure is 6-10 mm. Since the diameter of the spiral support structure is 6-10 mm, it can provide sufficient support force in the ureter and effectively prevent further collapse or blockage of the ureteral stenosis. The diameter of the fixing tube 120 is much smaller than the diameter of the supporting structure, so as to facilitate movement in the ureter and deliver the supporting structure to the designated position.

[0027] In one embodiment of the present invention, there are multiple support tubes 110, and the multiple support tubes 110 are arranged at intervals along the axial direction of the spiral support structure, and each support tube 110 forms a spiral support structure. When there are multiple strictures in the patient's ureter, each spiral support structure provides support force at a stricture to prevent further collapse or blockage of the stricture at that ureter.

[0028] like Figure 2 As shown, in one embodiment of the present invention, the main body 100 is provided with a first cavity 101 and a second cavity 102, the first cavity 101 extends along the length direction of the main body 100, the inner spaces of the support tube 110 and the fixing tube 120 are both part of the first cavity 101; the second cavity 102 is spaced apart from the first cavity 101, and the metal wire 200 is disposed in the second cavity 102. Furthermore, the material of the metal wire 200 is nickel-titanium alloy.

[0029] like Figure 3 As shown, by arranging the metal wire in the second cavity 102, the metal wire presents the same spiral structure as the supporting structure in the supporting structure, which can enhance the support performance and ensure that the support tube 110 can be restored to the spiral structure in time after the spiral embedded metal wire composite ureteral stent is placed in the human body. In addition, the setting of the metal wire can also prevent the spiral structure from being deformed due to the peristalsis of the ureter and the action of gravity, so that the spiral embedded metal wire composite ureteral stent falls excess length to the bladder, increasing the patient's sense of irritation. At the same time, the patient's urine can also flow through the first cavity 101, thereby improving or alleviating the dysuria caused by the patient's malignant ureteral stenosis. Therefore, the spiral embedded metal wire composite ureteral stent of this embodiment can not only ensure the support strength of the spiral embedded metal wire composite ureteral stent, but also enhance the patient's sense of use.

[0030] Furthermore, the nickel-titanium alloy has a shape memory effect, so that the metal wire 200 can automatically return to its original shape, thereby ensuring that the spiral support structure can promptly restore the spiral tight arrangement after being inserted into the patient's ureter.

[0031] In one embodiment of the present invention, the second cavity 102 extends along the length of the main body 100 ; alternatively, the second cavity 102 extends around the axial direction of the first cavity 101 and along a second spiral curve, and the second spiral curve surrounds the first cavity 101 .

[0032] In one embodiment of the present invention, there are multiple second cavities 102, and the multiple second cavities 102 are arranged at intervals; the metal wires 200 are arranged one-to-one corresponding to the second cavities 102. Since multiple metal wires are arranged in the main body 100, the supporting effect of the spiral embedded metal wire composite ureteral stent can be further improved.

[0033] In one embodiment of the present invention, the main body 100 is provided with a plurality of side holes 103, which are arranged at intervals along the length direction of the main body 100; the side holes 103 are connected to the first cavity 101. The main function of the side holes 103 is to drain urine, so that the patient's urine can enter the first cavity 101 through the side holes 103, which is conducive to draining urine between the inner wall of the stenosis area of ​​the ureter and the spiral embedded metal wire composite ureteral stent, further improving or alleviating the urination difficulties caused by the patient's malignant ureteral stenosis.

[0034] In one embodiment of the present invention, the main body 100 is made of one of polyurethane, polyolefin, and silicone rubber. These materials have good biocompatibility and avoid discomfort or other complications to patients. Therefore, their comfort level is far superior to that of metal stents.

[0035] In one embodiment of the present invention, the fixing tube 120 includes a fixing end 121 and a connecting end 122, and the connecting end 122 is connected to the support tube 110; the fixing end 121 extends along the second spiral curve to form a curled fixing structure, and the number of turns n of the curled fixing structure satisfies: 0.5<n<1.5; the diameter of the curled fixing structure is greater than the diameter of the ureter. When used, the curled fixing structures at both ends are respectively located in the renal pelvis and the bladder of the patient, so that the spiral support structure is located in the ureter. Among them, the curled fixing structures at both ends can prevent the spiral embedded metal wire composite ureteral stent from shifting when the patient's ureter moves; the spiral support structure is a tight spiral structure with a large support strength, and the metal wires are closely arranged to maintain the stability of the spiral support structure, so that the patient's urine can flow into the bladder through the inner circle of the support structure and the first cavity 101. In addition, the curled fixing structure has no edges and corners, which can not only play a better fixing role, but also has a relatively soft contact with the patient, reducing the patient's discomfort in use.

[0036] In one embodiment of the present invention, the openings of the two fixed ends 121 that are away from each other are subjected to rheological treatment, so that the second cavity 102 remains in a closed state, thereby preventing the metal wire from shifting or falling off.

[0037] The embodiments described above are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that the technical solutions described in the aforementioned embodiments may still be modified, or some of the technical features may be replaced by equivalents. Such modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention, and should all be included in the protection scope of the present invention.

Claims

1. A spiral embedded metal wire composite ureteral stent, characterized in that: It comprises a main body and a metal wire embedded in the main body, wherein the main body is made of a polymer elastic material; The main body comprises a support tube and fixing tubes located at both ends of the support tube, the support tube extends along a first spiral curve to form a spiral support structure; the fixing tubes are used to be arranged in the renal pelvis and bladder of the patient respectively.

2. The spiral embedded metal wire composite ureteral stent according to claim 1, characterized in that: The pitch of the spiral support structure is less than 1 mm.

3. The spiral embedded metal wire composite ureteral stent according to claim 1, characterized in that: The length of the spiral support structure is 1-20 cm; the diameter of the spiral support structure is 6-10 mm.

4. The spiral embedded metal wire composite ureteral stent according to claim 1, characterized in that: There are multiple support tubes, and the multiple support tubes are arranged at intervals along the axial direction of the spiral support structure; each support tube forms a spiral support structure.

5. The spiral embedded metal wire composite ureteral stent according to claim 1, characterized in that: The main body is provided with a first cavity and a second cavity, the first cavity extends along the length direction of the main body, and the internal spaces of the support tube and the fixed tube are both part of the first cavity; the second cavity is spaced apart from the first cavity, and the metal wire is arranged in the second cavity.

6. The spiral embedded metal wire composite ureteral stent according to claim 5, characterized in that: The second cavity extends along the length of the main body; or, the second cavity is arranged axially around the first cavity and extends along a second spiral curve, and the second spiral curve surrounds the first cavity.

7. The spiral embedded metal wire composite ureteral stent according to claim 5, characterized in that: There are multiple second cavities, and the multiple second cavities are arranged at intervals; the metal wires are arranged in a one-to-one correspondence with the second cavities.

8. The spiral embedded metal wire composite ureteral stent according to claim 5, characterized in that: The main body is provided with a plurality of side holes, which are arranged at intervals along the length direction of the main body; and the side holes are communicated with the first cavity.

9. The spiral embedded metal wire composite ureteral stent according to claim 1, characterized in that: The material of the metal wire is nickel-titanium alloy; and / or the material of the main body is one of polyurethane, polyolefin, and silicone rubber.

10. The spiral embedded metal wire composite ureteral stent according to claim 1, characterized in that: The fixing tube has a fixing end and a connecting end, wherein the connecting end is connected to the supporting tube; the fixing end extends along a second spiral curve to form a curling fixing structure, and the number of turns n of the curling fixing structure satisfies: 0.5<n<1.5.

Citation Information

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