A self-adapting high radial support ureteral stent

Abstract

The application provides a ureteral stent with adaptive high radial support force, which comprises a ureteral segment, a renal pelvis end segment and a bladder end segment connected to two ends of the ureteral segment, and drainage holes are arranged on the side surfaces of the renal pelvis end segment and the bladder end segment; the renal pelvis end segment and the bladder end segment are curved segments, and the ureteral segment is a straight segment; the ureteral segment comprises an inner cladding layer, an intermediate adaptive support layer and an outer cladding layer, the inner cladding layer and the outer cladding layer are respectively arranged on the inner and outer sides of the intermediate adaptive support layer, the inner cladding layer is connected to the inner side of the renal pelvis end segment and the bladder end segment in a smooth transition mode, and the outer cladding layer is connected to the outer side of the renal pelvis end segment and the bladder end segment in a smooth transition mode; the intermediate adaptive support layer comprises a plurality of support members, and the plurality of support members are distributed along the axial direction and the circumferential direction of the ureteral segment.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an adaptive ureteral stent with high radial support. Background Technology

[0002] A ureteral stent is a medical device widely used in urological clinics. It is implanted between the renal pelvis and the bladder to support and drain urine and protect kidney function.

[0003] Currently, the most widely used ureteral stents in clinical practice are single-lumen catheters extruded from polymer materials (such as TPU and silicone). They consist of two ends with coiled J-shaped segments (also known as double-J stents) for fixation to the renal pelvis and bladder to prevent displacement, respectively, and a straight segment within the ureter. Ureteral stents face many complex clinical situations, especially in cases of severe ureteral stricture, invasion of surrounding tissues by tumors, or retroperitoneal fibrosis, where they exert continuous, high-intensity pressure on the ureter. Silicone is relatively flexible, with a hardness generally less than 80A; TPU has some elasticity and a slightly higher hardness than silicone, but this is still limited. These stents cannot withstand high pressure and are prone to collapse, reducing the effective flow area and even causing loss of drainage function, which can lead to recurrent hydronephrosis and worsening of renal function.

[0004] To address the issue of insufficient support force in ureteral stents, the following are currently common improvement solutions: 1. Increase the wall thickness: For example, the J-shaped tubes at both ends are 8F and the straight tubes in the middle are 12F. This can improve the support, but it will over-dilate the ureter, increase patient discomfort, and reduce the effective drainage diameter.

[0005] 2. Designing special shapes: such as adding spiral columns or reinforcing ribs inside and outside the tube can improve the support of the stent tube, but it will increase the surface area of ​​the stent tube. Moreover, the complex structure is prone to urine retention, which increases the risk of biofilm and crust formation, thereby causing infection, blockage and difficulty in removal.

[0006] 3. Metal stents: Stents made of nickel-titanium alloy braided or laser-cut can provide excellent radial support. However, the complex surface structure of bare metal braided stents increases the risk of biofilm and crust formation. Moreover, the support function of the stent is prone to failure, causing ureteral restenosis and obstruction.

[0007] All three improvement schemes enhance the overall support of the ureteral stent, meaning that not only the ureter under pressure or obstruction is supported by the stent, but the normally functioning ureter also receives strong support, increasing patient discomfort. Summary of the Invention

[0008] To address the aforementioned technical problems, this invention provides an adaptive ureteral stent with high radial support, comprising a ureteral segment and a renal pelvis end segment and a bladder end segment connecting the two ends of the ureteral segment. Drainage holes are provided on the sides of both the renal pelvis end segment and the bladder end segment. Both the renal pelvis end segment and the bladder end segment are curved, while the ureteral segment is straight. The ureteral segment includes an inner covering layer, an intermediate adaptive support layer, and an outer covering layer. The inner and outer covering layers respectively cover the inner and outer sides of the intermediate adaptive support layer. The inner covering layer smoothly transitions to the inner sides of both the renal pelvis end segment and the bladder end segment, and the outer covering layer smoothly transitions to the outer sides of both the renal pelvis end segment and the bladder end segment. The intermediate adaptive support layer includes a plurality of support members, which are spaced apart along the axial and circumferential directions of the ureteral segment.

[0009] Optionally, in the circumferential direction of the ureteral segment, the intermediate adaptive support layer includes at least two of the supports, which are located on the same circle.

[0010] Optionally, the support member includes an arc-shaped portion and a support portion. The arc-shaped portion is arranged circumferentially along the ureteral segment, and a support portion is respectively provided on both sides of the inner surface of the arc-shaped portion along the circumferential direction of the ureteral segment. The length direction of the support portion is the axial direction of the ureteral segment, and the width direction of the support portion is the radial direction of the arc-shaped portion.

[0011] Optionally, at least one of the support portions is further provided at the center of the inner surface of the arc-shaped portion.

[0012] Optionally, the support member is embedded between the inner covering layer and the outer covering layer by a heat shrink bonding process.

[0013] Optionally, the inner covering layer, the outer covering layer, the renal pelvis end segment, and the bladder end segment are all made of a medical polymer material that combines flexibility and biocompatibility, and the gap between the inner surface of the arc-shaped portion and the inner covering layer is filled by the medical polymer.

[0014] Optionally, the inner covering layer, the outer covering layer, the renal pelvis end segment, and the bladder end segment are integrally extruded.

[0015] Optionally, the support member is made of metal.

[0016] Compared with the prior art, the technical solution of the embodiments of the present invention has the following beneficial effects: 1. This invention uses a support embedded in the ureteral segment as an intermediate adaptive support layer. In scenarios with high pressure, such as severe stenosis or tumor compression, it provides high radial support force while maintaining flexibility in normal ureteral segments. Therefore, this invention can automatically adjust the radial support force according to the pressure on the ureteral segment, ensuring continuous and effective urine drainage while reducing the discomfort caused to the patient by a single high-support stent tube.

[0017] 2. This invention isolates the intermediate adaptive support layer through an inner and outer covering layer, so that the outer surface of the ureteral tissue in direct contact with the urine and the inner surface in contact with the urine are both made of medical polymer materials such as organosilicon or TPU with high biocompatibility, low surface energy and anti-crusting properties, thereby minimizing the risk of biofilm formation and crusting.

[0018] 3. This invention also avoids problems such as patient discomfort and reduced drainage diameter caused by excessive expansion due to simply increasing the tube wall thickness, as well as problems such as urine retention and increased infection risk caused by complex spiral or reinforcing rib designs. The adaptive high radial support reduces patient discomfort. Simultaneously, the biocompatible layer coating solves the problems of bare metal stents being prone to crusting and biocompatibility risks.

[0019] Of course, any product implementing this invention does not necessarily need to achieve all of the advantages described above at the same time. Attached Figure Description

[0020] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0021] Figure 1 This is a schematic diagram of the structure of an adaptive high radial support ureteral stent tube provided in an embodiment of the present invention; Figure 2 This is a cross-sectional view of a ureteral segment provided in an embodiment of the present invention; Figure 3 This is a schematic diagram of the structure of a support member provided in an embodiment of the present invention; Figure 4 This is a cross-sectional view of a ureteral segment provided in another embodiment of the present invention; Figure 5 This is a schematic diagram of the deformation of an adaptive high radial support ureteral stent tube under significant pressure according to an embodiment of the present invention; Explanation of reference numerals in the attached figures: 1-- Renal pelvis end segment; 2--Ureteral segment; 201--Outer coating layer; 202--Supporting component; 2021 -- Curved section; 2022 -- Support section; 203 -- Inner cladding layer; 3--bladder end segment; 4--Drainage cavity; 5-- Drainage hole. Detailed Implementation

[0022] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0023] The terms "first," "second," "third," "fourth," etc. (if present) in the specification, claims, and accompanying drawings of this invention are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that embodiments of the invention described herein can be implemented in orders other than those illustrated or described herein. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion; for example, a process, method, system, product, or apparatus that comprises a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products, or apparatus. The terms "above" and "over," and any variations thereof, are intended to describe positional relationships and do not imply direct contact between the described objects.

[0024] Please refer to Figures 1 to 5 An embodiment of the present invention provides an adaptive high radial support ureteral stent tube, including a ureteral segment 2 and a renal pelvis end segment 1 and a bladder end segment 3 connecting the two ends of the ureteral segment 2. A drainage cavity 4 is formed inside the ureteral segment 2, the renal pelvis end segment 1, and the bladder end segment 3. Drainage holes 5 are provided on the sides of the renal pelvis end segment 1 and the bladder end segment 3. The drainage holes 5 are connected to the drainage cavity 4 to ensure normal drainage of urine.

[0025] Both the renal pelvis end segment 1 and the bladder end segment 3 are curved segments, such as circular structures that are curled in opposite directions, forming the renal pelvis connection end and the bladder connection end. The ureteral segment 2 is a straight segment used for insertion into the ureter.

[0026] The ureteral segment 2 includes an inner covering layer 203, an intermediate adaptive support layer, and an outer covering layer 201. The inner covering layer 203 and the outer covering layer 201 cover the inner and outer sides of the intermediate adaptive support layer, respectively. The inner covering layer 203 smoothly transitions to the inner side of the renal pelvis end segment 1 and the bladder end segment 3, respectively, and the outer covering layer 201 smoothly transitions to the outer side of the renal pelvis end segment 1 and the bladder end segment 3, respectively. The intermediate adaptive support layer includes a plurality of support members 202, which are distributed at intervals along the axial and circumferential directions of the ureteral segment 2.

[0027] During daily activities, especially bending over and standing up, the ureter bends with the body's twisting motion. Ureteral stents are typically 10-30 cm long; longer implants can irritate the ureter during movement. Stents that are rigid and have poor compliance can hinder ureteral bending, resulting in more pronounced stinging. To address this technical problem, in this embodiment, several support members 202 are spaced apart along the axial direction of the ureteral segment 2. This allows the ureteral segment 2 to bend with the patient's body twisting movements, such as bending over and standing up, thereby reducing patient discomfort.

[0028] Several of the support members 202 are spaced apart along the circumference of the ureteral segment 2. The radial support force of the intermediate adaptive support layer is related to the compressive force on the ureteral segment 2. Within a normal ureter, the ureteral segment 2 experiences relatively low compressive force, meaning the squeezing force and deformation are small. Therefore, the support members 202 do not contact each other, resulting in a small radial support force. Please refer to [reference needed]. Figure 1 When ureteral segment 2 is subjected to significant pressure, i.e., the compressive force on ureteral segment 2 is large and the deformation is significant, the gap between the support members 202 decreases until the support members 202 come into contact with each other to resist the compressive force on ureteral segment 2, thereby providing greater radial support force. This ensures that the drainage channel 4 within ureteral segment 2 does not lose its drainage function due to complete compression. Please refer to [reference needed]. Figure 5 .

[0029] In summary, this embodiment uses a support member 202 embedded in the ureteral segment 2 as an intermediate adaptive support layer. Under severe compression conditions such as severe stenosis or tumor compression, it provides high radial support force while maintaining flexibility in normal ureteral segments. Therefore, this embodiment can automatically adjust the radial support force according to the compression force on the ureteral segment 2, ensuring continuous and effective urine drainage while reducing the discomfort caused to the patient by a single high-support stent tube.

[0030] In this embodiment, the intermediate adaptive support layer includes at least two support members 202 in the circumferential direction of the ureteral segment 2. This embodiment does not limit the number of support members 202 in the circumferential direction of the ureteral segment 2. For example, there can be two, three, four or even more. These support members 202 are located on the same circle. Therefore, when the ureteral segment 2 deforms under the action of a large compressive force, the support members 202 can contact each other to form a circle.

[0031] Specifically, the support member 202 includes an arc-shaped portion 20201 and a support portion 20202. The arc-shaped portion 20201 is arranged circumferentially along the ureteral segment 2, and a support portion 20202 is respectively provided on both sides of the inner surface of the arc-shaped portion 20201 along the circumferential direction of the ureteral segment 2. The length direction of the support portion 20202 is the axial direction of the ureteral segment 2, and the width direction of the support portion 20202 is the radial direction of the arc-shaped portion 20201. When the ureteral segment 2 deforms under a large compressive force, the support portion 20202 can prevent misalignment when two adjacent support members 202 come into contact with each other.

[0032] Furthermore, at least one support portion 20202 is provided at the center of the inner surface of the arc-shaped portion 20201, please refer to... Figure 4 The purpose is to further provide high radial support to resist external pressure.

[0033] In this embodiment, the support member 202 is embedded between the inner covering layer 203 and the outer covering layer 201 by heat shrinking and pressing process.

[0034] Specifically, the inner covering layer 203, the outer covering layer 201, the renal pelvis end segment 1, and the bladder end segment 3 are all made of medical polymer materials such as silicone and TPU, which combine flexibility and biocompatibility. This ensures biocompatibility, reduces tissue reaction, and forms a smooth drainage channel 4, minimizing the risk of biofilm formation and crusting. The gap between the inner surface of the arc-shaped portion 20201 and the inner covering layer 203 is filled with the medical polymer.

[0035] Furthermore, the inner covering layer 203, the outer covering layer 201, the renal pelvis end segment 1, and the bladder end segment 3 are integrally extruded to ensure that the ureteral segment 2 smoothly transitions to the renal pelvis end segment 1 and the bladder end segment 3, respectively, facilitating catheter insertion.

[0036] This embodiment does not impose specific restrictions on the material of the support member 202, as long as it can provide radial support force to prevent the drainage cavity 4 from being completely squeezed when the ureteral segment 2 is subjected to large pressure. For example, the support member 202 is made of metal.

[0037] In this embodiment, the intermediate adaptive support layer is isolated by the inner covering layer 203 and the outer covering layer 201, so that the outer surface of the ureteral tissue in direct contact with the urine and the inner surface in contact with the urine are both made of medical polymer materials such as organosilicon or TPU with high biocompatibility, low surface energy and anti-crusting properties, thereby minimizing the risk of biofilm formation and crusting.

[0038] This embodiment also avoids problems such as patient discomfort and reduced drainage diameter caused by over-expansion due to simply increasing the tube wall thickness, as well as problems such as urine retention and increased infection risk caused by complex spiral or reinforcing rib designs. The adaptive high radial support reduces patient discomfort. At the same time, the biocompatibility layer coating solves the problems of bare metal stents being prone to crusting and biocompatibility risks.

[0039] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. An adaptive ureteral stent with high radial support, comprising a ureteral segment and a renal pelvis end segment and a bladder end segment connecting the two ends of the ureteral segment, wherein drainage holes are provided on the sides of both the renal pelvis end segment and the bladder end segment; both the renal pelvis end segment and the bladder end segment are curved sections, and the ureteral segment is a straight section; characterized in that, The ureteral segment includes an inner covering layer, an intermediate adaptive support layer, and an outer covering layer. The inner covering layer and the outer covering layer cover the inner and outer sides of the intermediate adaptive support layer, respectively. The inner covering layer smoothly transitions to the inner side of the renal pelvis end segment and the bladder end segment, respectively, and the outer covering layer smoothly transitions to the outer side of the renal pelvis end segment and the bladder end segment, respectively. The intermediate adaptive support layer includes a plurality of support members, which are spaced apart along the axial and circumferential directions of the ureteral segment.

2. The ureteral stent tube according to claim 1, characterized in that, In the circumferential direction of the ureteral segment, the intermediate adaptive support layer includes at least two support members located on the same circle.

3. The ureteral stent tube according to claim 2, characterized in that, The support member includes an arc-shaped portion and a support portion. The arc-shaped portion is arranged along the circumference of the ureteral segment, and a support portion is provided on each side of the inner surface of the arc-shaped portion along the circumference of the ureteral segment. The length direction of the support portion is the axial direction of the ureteral segment, and the width direction of the support portion is the radial direction of the arc-shaped portion.

4. The ureteral stent tube according to claim 3, characterized in that, At least one support portion is also provided in the middle of the inner surface of the arc-shaped portion.

5. The ureteral stent tube according to claim 3, characterized in that, The support member is embedded between the inner and outer covering layers using a heat-shrink lamination process.

6. The ureteral stent tube according to claim 5, characterized in that, The inner covering layer, the outer covering layer, the renal pelvis end segment, and the bladder end segment are all made of a medical polymer material that combines flexibility and biocompatibility. The gap between the inner surface of the arc-shaped portion and the inner covering layer is filled by the medical polymer.

7. The ureteral stent tube according to claim 1, characterized in that, The inner covering layer, the outer covering layer, the renal pelvis end segment, and the bladder end segment are integrally extruded.

8. The ureteral stent tube according to claim 1, characterized in that, The support component is made of metal.

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