Physiological compliance ureteral stent

Abstract

The invention belongs to the technical field of medical instruments, and relates to a physiological compliance ureteral stent which comprises a first supporting part and a second supporting part, and the first supporting part and the second supporting part are connected through a second connector set; the first supporting part is of a cylindrical hollow structure; the second supporting part is a cylinder, a plurality of sets of carved structures are distributed on the second supporting part in the axial direction of the second supporting part, and the distance between every two adjacent carved structures is gradually increased from the end close to the first supporting part to the end away from the first supporting part. The catheter has good biocompatibility and morphological compliance, and can better fit the natural anatomical structure of the ureter, so that more complete and efficient urine drainage is realized.

Description

Technical Field

[0001] The present application belongs to the technical field of medical devices and relates to a physiologically compliant ureteral stent. Background Art

[0002] Ureteral stenosis refers to a condition in which part or all of the ureteral lumen is narrower than normal. Although the continuity of the lumen is not interrupted, it has caused varying degrees of upper urinary tract obstruction and hydronephrosis. Ureteral stenosis may be caused by a variety of reasons, such as congenital factors, infectious factors, improper surgical operation, or external pressure stenosis. Clinically, patients often present with symptoms such as bloating and pain in the waist and abdomen, bladder irritation symptoms, nausea, vomiting, anorexia, and may also experience symptoms such as general discomfort, fever, and chills. The treatment of ureteral stenosis is mainly determined by the cause, severity of the disease, and the specific situation of the patient. The treatment goal is mainly to relieve upper urinary tract obstruction, protect renal function, and prevent the occurrence of complications. Treatment methods include two categories: non-surgical treatment and surgical treatment.

[0003] 1. Non-surgical treatment: For patients with mild stenosis or mild symptoms, non-surgical treatment methods can be used, such as drug therapy, observation and follow-up, etc. Drug therapy is mainly aimed at stenosis caused by infection, and antibiotics can be used for treatment.

[0004] 2. Surgical treatment: For patients with severe stenosis or severe symptoms, surgical treatment is usually required. The choice of surgical method needs to be determined based on the patient's specific condition and the location of the stenosis.

[0005] Ureteral stent implantation is a commonly used surgical treatment for ureteral stenosis. When the ureter is blocked from flowing urine due to various reasons such as stones, inflammation, tumor compression, etc., a ureteral stent is needed to keep the urinary tract unobstructed. A catheter-like stent is inserted into the ureter through the urethra to allow urine to flow normally. Ureteral stent implantation has the advantages of quickly restoring urinary tract patency, less surgical trauma, and a wide range of applications. Ureteral stents are generally made of memory alloy materials. Although they have good biocompatibility and support, there are still some problems.

[0006] The main problems with current ureteral stents are: 1) The drainage of the stent is incomplete and cannot fit the natural anatomical structure of the ureter, so it is impossible to achieve more complete and efficient urine drainage; 2) The stent has weak pressure resistance. Under the pressure generated by the flow of urine, the stent cannot maintain a stable shape and position. This pressure resistance makes it impossible for general ureteral stents to exert a stable therapeutic effect in complex environments. 3) The stent exists as a foreign body in the urinary tract, with poor comfort, and it is easy to irritate the urinary tract, causing urinary tract infection or other complications. Therefore, it is necessary to solve the problems of existing stents through stent structure optimization and material improvement. Summary of the invention

[0007] In view of the above-mentioned shortcomings of the prior art, the purpose of the present application is to provide a physiologically compliant ureteral stent with good biocompatibility and morphological compliance, complete drainage, strong pressure resistance, high comfort, and degradable ureteral stent.

[0008] In order to achieve the above purpose, the technical solution adopted in this application is:

[0009] The present application provides a physiologically compliant ureteral stent, comprising a first support portion and a second support portion, wherein the first support portion and the second support portion are connected via a second connector group; the first support portion is a cylindrical hollow structure; the second support portion is a cylinder, and the second support portion has a plurality of groups of carved structures distributed along its axial direction, and the spacing between adjacent carved structures increases successively from one end close to the first support portion to the end far from the first support portion.

[0010] In some embodiments of the present application, the first supporting portion includes a plurality of groups of annular bodies and a plurality of groups of first connecting body groups that are sequentially spaced apart, and adjacent annular bodies are connected via the first connecting body groups.

[0011] In some embodiments of the present application, the material of the physiologically compliant ureteral stent is a biodegradable material.

[0012] In some embodiments of the present application, each group of the annular bodies is composed of N support rods connected end to end in the circumferential direction, where N≥4 and N is an integer.

[0013] In some embodiments of the present application, each group of the first connectors includes M first connectors distributed at circumferential intervals, M≥2 and M is an integer, and the first connectors are connected to the support rods.

[0014] In some embodiments of the present application, the wave crests of the support rods on two adjacent annular bodies are staggered, and a plurality of the first connectors located in the same circumferential direction are arranged at intervals, and the front and rear ends of the first connectors are respectively connected to the wave troughs and wave crests of the support rods on two adjacent annular bodies.

[0015] In some embodiments of the present application, the support rod is U-shaped, and the first connector is I-shaped.

[0016] In some embodiments of the present application, the second connector group includes F circumferentially distributed second connectors, where F≥2 and F is an integer.

[0017] In some embodiments of the present application, each group of the carved structures includes a plurality of carved units; in the circumferential direction, the plurality of carved units are equidistantly arranged, and a plurality of rectangular holes are provided between adjacent carved units.

[0018] In some embodiments of the present application, the carved unit is an Ω-shaped unit.

[0019] In some embodiments of the present application, the number of the carved units arranged circumferentially is H, H≥4 and H is an integer.

[0020] In some embodiments of the present application, the Ω-shaped unit includes a first arc and a second arc, the first arc includes a first curvature radius, the second arc includes a second curvature radius; the first curvature radius is greater than the second curvature radius.

[0021] In some embodiments of the present application, the diameter of the neck of the carving unit is smaller than the maximum diameter of the head of the carving unit.

[0022] In some embodiments of the present application, a neck diameter of the carved unit is smaller than a second curvature radius of the second arc.

[0023] In some embodiments of the present application, the first radius of curvature ranges from 0.6 mm to 1.0 mm, and the second radius of curvature ranges from 0.4 mm to 0.8 mm.

[0024] Due to the application of the above technical solution, the present application has the following advantages compared with the prior art:

[0025] The present application includes a first support portion and a second support portion, wherein the first support portion is a cylindrical hollow structure and can be precisely positioned by balloon expansion. The second support portion is a cylindrical carved structure, which is repeatedly arranged in the axial direction. When arranged in the axial direction, the spacing of each row increases successively, presenting an arrangement from dense to sparse. The flexibility of the front section is ensured to be good and the supporting capacity of the rear end is strong. The first support portion and the second support portion are connected by a second connector group. The present application provides a physiologically compliant ureteral stent, which has good biocompatibility and morphological compliance, and can better fit the natural anatomical structure of the ureter, thereby achieving more complete and efficient urine drainage. Compared with traditional stents, compliant stents can reduce the retention of urine between the stent and the ureteral wall, effectively reducing the risk of infection and stones caused by urine retention. Under the pressure generated by the flow of urine, the stent can still maintain a stable shape and position, ensuring smooth urine drainage, and can also effectively reduce urine reflux and urine leakage, further improving the patient's comfort. In addition, the stent is degradable and does not need to be removed a second time. It can be excreted from the body with the flow of urine. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 This is a schematic diagram of the three-dimensional structure of the physiologically compliant ureteral stent of the present application;

[0027] Figure 2 This is an expanded view of the physiologically compliant ureteral stent of this application;

[0028] Figure 3 A three-dimensional diagram of the physiologically compliant ureteral stent of the present application in a compressed and gripped state;

[0029] Figure 4 A three-dimensional diagram of the physiologically compliant ureteral stent in the expanded state of the present application;

[0030] Figure 5 This is an enlarged view of the support rod of this application;

[0031] Figure 6 This is an enlarged view of the carved unit of the second supporting part of the present application.

[0032] Component numbers in the figure

[0033] 1 First support

[0034] 11 Ring

[0035] 111 Support rod

[0036] 12 First connector group

[0037] 121 First Connector

[0038] 2 Second connector group

[0039] 21 Second connector

[0040] 3 Second support part

[0041] 31 Carved structure

[0042] 311 First Arc

[0043] 312 Second Arc

[0044] 32 Rectangular hole DETAILED DESCRIPTION

[0045] In the description of the present application, it should be noted that the structures, proportions, sizes, etc. illustrated in the drawings of the present specification are only used to match the contents disclosed in the specification for people familiar with the technology to understand and read, and are not used to limit the limiting conditions that can be implemented in the present application, so they have no technical substantive significance. Any modification of the structure, change of the proportion relationship or adjustment of the size, without affecting the effects that can be produced by the present application and the purposes that can be achieved, should still fall within the scope of the technical content disclosed in the present application. At the same time, the orientation or position relationship indicated by the terms "center", "longitudinal", "lateral", "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc. is based on the orientation or position relationship shown in the drawings, which is only for the convenience of describing the present application 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 a limitation to the present application. In addition, the terms "first" and "second" are only used for descriptive purposes and cannot be understood as indicating or implying relative importance.

[0046] In the description of this application, 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 this application can be understood according to specific circumstances.

[0047] Furthermore, in the description of the present application, unless otherwise specified, “plurality” means two or more.

[0048] like Figures 1 to 6 , the embodiment of the present application provides a physiologically compliant ureteral stent, including a first support portion 1 and a second support portion 3, wherein the first support portion 1 and the second support portion 3 are connected by a second connector group 2; the first support portion 1 is a cylindrical hollow structure; the second support portion 3 is a cylinder, and the second support portion 3 has multiple groups of carved structures 31 distributed along its axial direction, and the spacing between adjacent carved structures 31 increases successively from one end close to the first support portion 1 to the end away from the first support portion 1. Since the first support portion 1 of the present application is a cylindrical hollow structure, precise positioning can be achieved by balloon expansion. The second support portion 3 is a cylindrical carved structure 31, and when arranged axially, the spacing between each row increases successively, presenting an arrangement from dense to sparse. The purpose is to make the stent have good morphological compliance and gradually enhance its compressive resistance. Ensure good flexibility in the front section and strong support capacity in the rear end.

[0049] In the physiologically compliant ureteral stent provided in the embodiment of the present application, the material of the physiologically compliant ureteral stent is a biodegradable material. Optionally, the material of the stent in this embodiment is one or more of stainless steel, memory alloy, titanium alloy, tantalum alloy, cobalt-chromium alloy, biodegradable metal, biodegradable polymer, magnesium alloy, and pure iron. This embodiment adopts a biodegradable polymer material and a biodegradable material, and the degraded part can be excreted from the body with urine, which not only plays a therapeutic role during the treatment period, but also avoids the long-term retention or removal process of the stent.

[0050] In the physiologically compliant ureteral stent provided in the embodiment of the present application, the first support portion 1 is a cylindrical hollow structure. Figure 1 and 2 The first support part 1 includes a plurality of groups of annular bodies 11 and a plurality of groups of first connectors 12 which are sequentially spaced and connected to each other. Adjacent annular bodies 11 are connected by the first connectors 12. A plurality of first connectors 12 and a plurality of annular bodies 11 constitute the first support part 1, and the first support part 1 is used to support the position where the renal pelvis and the ureter are connected. When used, the first support part 1 is expanded by a balloon and fixed at the renal pelvis.

[0051] Furthermore, if Figure 2 Each group of the annular bodies 11 is composed of N support rods 111 connected end to end in the circumferential direction, N ≥ 4 and N is an integer. Optionally, the number N of the support rods 111 is 4-20. Optionally, the axial effective length of the support rods 111 is 1mm-2mm and the width is 0.05-0.3mm. In this embodiment, the axial effective length of the support rods 111 is 1.5mm and the width is 0.2mm.

[0052] Further, each group of the first connector group 12 includes M first connectors 121 distributed at intervals in the circumferential direction, M ≥ 2 and M is an integer, and the first connector 121 is connected to the support rod 111. Optionally, the number M of the first connectors 121 is 2-18. Optionally, the first connector 121 has an effective axial length of 0.2 mm-2 mm and a width of 0.05-0.3 mm. In this embodiment, the effective axial length of the first connector 121 is 0.3 mm and the width is 0.06 mm.

[0053] Furthermore, if Figure 2 The wave crests of the support rods 111 on two adjacent annular bodies 11 are staggered, and a plurality of the first connectors 121 located in the same circumferential direction are arranged at intervals, and the front and rear ends of the first connector 121 are respectively connected to the wave troughs and wave crests of the support rods 111 on two adjacent annular bodies 11.

[0054] Furthermore, if Figure 2The support rod 111 is U-shaped, and the annular body 11 formed by the plurality of support rods 111 is a closed wave structure. The annular body 11 has wave crests, and the wave crests of two adjacent annular bodies 11 are staggered.

[0055] Furthermore, if Figure 2 , the first connector 121 is I-shaped. In the first support portion 1 , two ends of the first connector 121 are connected to the troughs and crests of the two support rods 111 , respectively.

[0056] In the physiologically compliant ureteral stent provided in the embodiment of the present application, the second connector group 2 is used to connect the first support part 1 and the second support part 3; Figure 2 The second connector group 2 includes F circumferentially distributed second connectors 21, where F≥2 and F is an integer. Optionally, the number F of the second connectors 21 is 4-20.

[0057] In the physiologically compliant ureteral stent provided in the embodiments of the present application, Figures 1 to 4 The second support part 3 has multiple groups of carved structures 31 distributed along its axial direction, and each group of the carved structures 31 includes multiple carved units; in the circumferential direction, multiple carved units are arranged equidistantly, and multiple rectangular holes 32 are provided between adjacent carved units to make the degradation more uniform. Figure 2 , in the circumferential direction, each row has three columns of identical rectangular holes 32. Optionally, the size of each rectangular frame is 0.9 mm×0.2 mm.

[0058] Furthermore, the carved units are Ω-shaped units. The number of the carved units arranged circumferentially is H, H≥4 and H is an integer.

[0059] Furthermore, if Figure 2 and 6 The Ω-shaped unit includes a first arc 311 and a second arc 312, wherein the first arc 311 includes a first radius of curvature, and the second arc 312 includes a second radius of curvature; the first radius of curvature is greater than the second radius of curvature. In some embodiments, the first radius of curvature is in the range of 0.6 mm to 1.0 mm, and the second radius of curvature is in the range of 0.4 mm to 0.8 mm.

[0060] Further, the neck diameter of the carving unit is smaller than the maximum diameter of the head of the carving unit; and / or the neck diameter of the carving unit is smaller than the second curvature radius of the second arc 312. The purpose is to clamp the inner ring and prevent it from falling off.

[0061] In the physiologically compliant ureteral stent provided in the embodiment of the present application, the first supporting portion 1, the second connector group 2, and the second supporting portion 3 are connected in sequence.

[0062] In the physiologically compliant ureteral stent provided in the embodiment of the present application, optionally, the overall axial effective length of the physiologically compliant ureteral stent is 200mm-300mm, and the overall axial effective length of the present embodiment is 200-250mm.

[0063] Optionally, the effective axial length of the first support portion 1 is 10 mm to 40 mm. The effective axial length of the second support portion 3 is 160 mm to 240 mm.

[0064] The working method of the physiologically compliant ureteral stent provided in the embodiment of the present application is:

[0065] When used, the physiologically compliant ureteral stent is delivered into the ureter by a delivery system. Figure 4 The first support part 1 is expanded by the balloon and fixed at the renal pelvis.

[0066] The first support part 1 supports the connection between the renal pelvis and the ureter, and the second support part 3 is located in the ureter to divert urine. The carved structure 31 on the second support part 3 is repeatedly arranged axially, and the spacing of each row increases successively, showing an arrangement from dense to sparse, to ensure that the front end has good flexibility and the back end has good support performance. As the treatment time goes by, the degradation products of the stent can be discharged from the body with urine, avoiding secondary damage such as retention or removal.

[0067] In summary, the physiologically compliant ureteral stent of the present application includes a first support portion 1 and a second support portion 3. The first support portion 1 is a cylindrical hollow structure, which can be precisely positioned by balloon expansion. The second support portion 3 is a cylindrical carved structure, which is repeatedly arranged in the axial direction. When arranged in the axial direction, the spacing of each row increases successively, presenting an arrangement from dense to sparse. Ensure good flexibility of the front section and strong support capacity of the rear end. The first support portion 1 and the second support portion 3 are connected by a second connector group 2. A physiologically compliant ureteral stent provided in the present application has good biocompatibility and morphological compliance, and can better fit the natural anatomical structure of the ureter, thereby achieving more complete and efficient urine drainage. Compared with traditional stents, compliant stents can reduce the retention of urine between the stent and the ureteral wall, effectively reducing the risk of infection and stones caused by urine retention. Under the pressure of urine flow, the stent can still maintain a stable shape and position, ensuring smooth urine drainage, and effectively reducing urine reflux and urine leakage, further improving the patient's comfort. In addition, the stent is degradable and does not need to be removed a second time. It can be excreted from the body as urine flows.

[0068] In summary, the present application effectively overcomes various shortcomings in the prior art and has high industrial utilization value.

[0069] The above embodiments are merely illustrative of the principles and effects of the present application and are not intended to limit the present application. Anyone familiar with the technology may modify or change the above embodiments without violating the spirit and scope of the present application. Therefore, all equivalent modifications or changes made by a person of ordinary skill in the art without departing from the spirit and technical ideas disclosed in the present application shall still be covered by the claims of the present application.

Claims

1. A physiologically compliant ureteral stent, characterized in that: The invention comprises a first supporting part (1) and a second supporting part (3), wherein the first supporting part (1) and the second supporting part (3) are connected via a second connecting body group (2); the first supporting part (1) is a cylindrical hollow structure; the second supporting part (3) is a cylinder, and the second supporting part (3) has a plurality of groups of carved structures (31) distributed along its axial direction, and the spacing between adjacent carved structures (31) increases in sequence from one end close to the first supporting part (1) to the end far from the first supporting part (1).

2. The physiologically compliant ureteral stent according to claim 1, characterized in that: The first supporting portion (1) comprises a plurality of groups of annular bodies (11) and a plurality of groups of first connecting bodies (12) which are sequentially spaced apart, and adjacent annular bodies (11) are connected via the first connecting body groups (12); And / or, the material of the physiologically compliant ureteral stent is a biodegradable material.

3. The physiologically compliant ureteral stent according to claim 2, characterized in that: Each group of the annular bodies (11) is composed of N support rods (111) connected end to end in the circumferential direction, where N is ≥ 4 and N is an integer; And / or, each group of the first connectors (12) comprises M first connectors (121) distributed at circumferential intervals, M≥2 and M is an integer, and the first connectors (121) are connected to the support rods (111).

4. The physiologically compliant ureteral stent according to claim 3, characterized in that: The wave crests of the support rods (111) on two adjacent annular bodies (11) are arranged in a staggered manner, and a plurality of the first connecting bodies (121) located in the same circumferential direction are arranged at intervals, and the front and rear ends of the first connecting body (121) are respectively connected to the wave troughs and wave crests of the support rods (111) on two adjacent annular bodies (11).

5. The physiologically compliant ureteral stent according to claim 4, characterized in that: The support rod (111) is U-shaped, and the first connecting body (121) is I-shaped.

6. The physiologically compliant ureteral stent according to claim 1, characterized in that: The second connector group (2) comprises F circumferentially distributed second connectors (21), where F≥2 and F is an integer.

7. The physiologically compliant ureteral stent according to claim 1, characterized in that: Each group of the carved structures (31) comprises a plurality of carved units; in the circumferential direction, the plurality of carved units are arranged equidistantly in the circumferential direction, and a plurality of rectangular holes (32) are provided between adjacent carved units.

8. The physiologically compliant ureteral stent according to claim 7, characterized in that: The carved unit is an Ω-shaped unit; And / or, the number of the carved units arranged circumferentially is H, H≥4 and H is an integer.

9. The physiologically compliant ureteral stent according to claim 8, characterized in that: The Ω-shaped unit comprises a first arc (311) and a second arc (312), the first arc (311) comprises a first curvature radius, the second arc (312) comprises a second curvature radius; the first curvature radius is greater than the second curvature radius.

10. The physiologically compliant ureteral stent according to claim 9, characterized in that: The diameter of the neck of the carving unit is smaller than the maximum diameter of the head of the carving unit; and / or, the neck diameter of the carved unit is smaller than the second curvature radius of the second arc (312); And / or, the first radius of curvature is in the range of 0.6 mm to 1.0 mm, and the second radius of curvature is in the range of 0.4 mm to 0.8 mm.

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