Ureteral stent

Abstract

To provide improved and reliable ureteral stent configurations that are configured for increased patient comfort.SOLUTION: Disclosed herein is a ureteral stent. The ureteral stent includes a proximal end, a distal end, and a middle portion. The proximal end includes a retention feature having a coiled shape. The distal end is opposite the proximal end. The middle portion is between the proximal end and the distal end.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a urinary catheter stent, and more specifically, to a comfortable urinary catheter stent.

Background Art

[0002] The ureter is a tubular passage in the body that conveys urine from the kidney to the bladder. A ureteral stent is used to facilitate urine drainage from the kidney to the bladder in patients with ureteral obstruction or ureteral injury, or to protect the integrity of the ureter in various surgical procedures. A ureteral stent is typically a hollow catheter-like device about 30 cm in length, made of a polymer, with its distal end located within the kidney and its proximal end not located within the bladder while being placed within the ureter.

Summary of the Invention

Problems to be Solved by the Invention

[0003] Therefore, there is a need to provide a configuration for an improved and reliable ureteral stent that is configured to enhance patient comfort.

Means for Solving the Problems

[0004] According to one aspect of the present invention, a ureteral stent is disclosed. The ureteral stent includes a proximal end, a distal end, and an intermediate portion. The proximal end includes a holding mechanism having a coil shape. The distal end is on the opposite side of the proximal end. The intermediate portion is between the proximal end and the distal end.

[0005] The foregoing aspect and other features of the present invention are related to the accompanying drawings and will be described in the following description.

Brief Description of the Drawings

[0006] [Figure 1] A partial perspective view of a ureteral stent incorporating the features of the present invention (within the patient's body). [Figure 2] Another perspective view of the ureteral stent shown in FIG. 1. [Figure 3] This is a cross-sectional view of the cutting line indicated in Figure 2. [Figure 4] This is a magnified view of the area indicated in Figure 2. [Figure 5] Figure 1 is a partial view of the tail portion of the ureteral stent shown. [Figure 6] Figure 1 is a perspective view of an alternative configuration for the floating tip portion of the ureteral stent. [Figure 7] Figure 1 is a perspective view of an alternative configuration for the floating tip portion of the ureteral stent. [Figure 8] This is a perspective view of another exemplary ureteral stent incorporating features of the present invention. [Figure 9] Figure 8 is a cross-sectional view of the indicated cutting line. [Figure 10] Figure 8 shows an alternative embodiment of the proximal end. [Figure 11] Figure 10 is a perspective view showing the fixing device corresponding to the proximal end. [Figure 12] This is a diagram of another alternative embodiment of the proximal end shown in Figure 8. [Figure 13] This is a diagram of another alternative embodiment of the proximal end shown in Figure 8. [Figure 14] This is a perspective view of another exemplary ureteral stent incorporating features of the present invention. [Figure 15] Figure 14 is a cross-sectional view of the indicated cutting line. [Figure 16] Figure 14 is a top view of the ureteral stent shown. [Figure 17] This diagram shows the configuration of alternative external valves according to various embodiments of ureteral stents. [Figure 18] This diagram shows the configuration of alternative external valves according to various embodiments of ureteral stents. [Figure 19] This diagram shows the configuration of alternative external valves according to various embodiments of ureteral stents. [Figure 20] This diagram shows the configuration of alternative external valves according to various embodiments of ureteral stents. [Figure 21]It is a diagram of the configuration of an alternative proximal portion according to various embodiments of a ureteral stent. [Figure 22] It is a diagram of the configuration of an alternative proximal portion according to various embodiments of a ureteral stent. **Embodiments for Carrying Out the Invention**

[0007] Referring to FIG. 1, a partial perspective view of a ureteral stent 10 incorporating the features of the present invention is shown. The present invention will be described with reference to the exemplary embodiments shown in the drawings, but it should be understood that the present invention can be embodied in many alternative forms of the embodiments. In addition, any suitable dimensions, shapes, or types of elements or materials can be used.

[0008] The ureteral stent 10 includes a tubular member 12 having a proximal end 14, an opposite distal end 16, and an intermediate portion 18 between the proximal end 14 and the distal end 16. The proximal end 14 is configured to be disposed within the renal pelvis 20 of the kidney 22. The distal end 16 is configured to be disposed within the bladder 24.

[0009] Referring also to FIG. 2 here, the proximal end 14 includes a coiled body (or shape) having a conical spiral shape 26. The conical spiral shape 26 extends in a direction away from the intermediate portion 18, and as the conical spiral shape extends in a direction away from the intermediate portion, the diameter of the conical spiral shape 26 increases, and the first open end 28 of the stent 10 is at a substantially maximum diameter portion of the conical spiral shape 26.

[0010] The conical spiral shape 26 of the proximal end 14 is configured to enable fixation of the proximal end 14 within the renal pelvis. Thereby, a holding mechanism is provided that reduces the contact force applied to the renal pelvis wall (of the renal pelvis 20) by increasing the contact surface area between the proximal end and the renal pelvis wall when compared to conventional configurations.

[0011] The intermediate portion 18 includes a side hole (or opening) 30 extending through the wall of the tubular member. Referring again to section 3-3, the side hole 30 is configured to have a smooth edge (or smooth opening surface) 32. The smooth edge may be provided by any suitable mechanical or preparation work that can round the edge (such as providing a fillet, blend, corner radius, or rounded corner on the edge 32). According to various exemplary embodiments, the smoothing process may include a punching process in which the polymer melts while removing any sharp edges during punching. The edges may also be melted post-processing, for example, with hot air, flame, or hot tools. The smooth edge may provide any suitable edge area of ​​the hole 32 between the inner and outer diameters of the tubular member.

[0012] While various drawings illustrate the stent 10 with four side holes 30 in the intermediate section 18, it should be noted that those skilled in the art will understand that various exemplary embodiments are not necessarily limited in this way, and alternative embodiments may include any preferred number of side holes. For example, in some embodiments, the stent may have one or more side holes, and in other embodiments, the stent may have five or more side holes, or any number of side holes may be provided. Furthermore, the side holes 30 may be provided in any one of the proximal end 14, distal end 16, and / or intermediate section 18, or in any combination thereof, including end retaining portions or other shaped mechanisms (while having any preferred number of side holes in each end 14, 16, or intermediate section 18).

[0013] When the urethra expands and contracts due to the bladder's urination function, the ureter rubs against the edge 32 of the hole 30 due to this movement. This "smooth" hole configuration is configured to reduce irritation and patient pain. In addition to the smooth aspect of the hole edge configuration for patient comfort, the smooth edge is also provided to reduce urine flow turbulence (as it promotes encrustation). Regardless of whether it is gravity-fed or due to the peristaltic action of the ureter itself, the smooth edge configuration of this hole can reduce turbulence while the ureter flows down. Furthermore, the position of the hole can play a role in urine reflux (further described below).

[0014] According to various exemplary embodiments, the stent 10 may further include an external reflux skirt 34 and / or an internal reflux valve 36 between the intermediate portion 18 and the distal end 16. The external reflux skirt 34 surrounds a portion of a tubular member having a generally conical shape and is configured to minimize external reflux. The internal reflux valve 36 is configured to provide a one-way flow through the tubular member (see arrow 38). According to various exemplary embodiments, the internal reflux valve 36 may be a duckbill valve, but in alternative embodiments, any suitable type of valve that allows one-way flow, such as a check valve, may be provided.

[0015] The distal end 16 includes a tail portion (or tip portion) 40 configured to be received in the bladder in close proximity to a zone or region called the “trigon.” The trigon has a large number of nerve endings that communicate the need to empty the bladder and when urination is complete. Contact with the trigon zone causes a great deal of discomfort to the patient. The tail portion 40 contains a foaming material and is configured to “float” in the water / urine in the bladder, minimizing (or eliminating) contact with the trigon (e.g., by foam with a specific gravity < 1.0) in the presence of any urine. Although the tail portion has been described above as having a foaming material, those skilled in the art will understand that exemplary embodiments are not necessarily limited in this way, and alternative embodiments may include any preferred material configured to float in the bladder, such as a configuration having air “trapped” in the sidewalls to achieve buoyancy.

[0016] According to various exemplary embodiments, the tail portion 40 may further include a one-way urinary valve 42 that allows for a reduction in urinary return (the backflow of urine through the ureter to the kidney). The configuration of the distal tail 40 including the one-way valve 42 does not require additional components because it includes a folded tubular heat set mechanism as shown in Figure 5. According to various exemplary embodiments, the configuration of the one-way urinary valve 42 may be similar to that of a duckbill valve, although the duckbill valve is generally wider than the normal tubular outer diameter (OD), and the four-wing valve may be smaller than the OD. In some embodiments, multiple-wing configurations may also be applied. In situ, the one-way valve 42 substantially eliminates return through the inside of the stent rather than outside the stent.

[0017] Figures 6 and 7 illustrate alternative configurations for the floating tip portion. The floating tip portion 140 is similar to the tip portion 40, but in this embodiment, the tip portion 140 includes a tapered portion 142. Furthermore, the floating tip portion 240 is similar to the tip portion 40 and includes a recirculation valve 242 fitted into the end of the tubular member 12.

[0018] According to various exemplary embodiments, external anti-reflux mechanisms 34, 36 may be provided to substantially eliminate urine flow around the outside of the stent. A reduction in urine return is achieved by combining a distal valve 42 in the bladder with an external valve 36 near the midpoint of the stent, and by providing a hole 30 with a smooth, low-turbulence side edge 32 above or on the renal side of the external return mechanism. Furthermore, in some embodiments, the distal end 16 may include a J-shaped hook movement lock 44 configured to prevent stent movement due to patient movement.

[0019] Referring again to Figure 8, another embodiment of the stent is shown. In this embodiment, the stent 300 comprises a distal end 316 similar to the distal end 16 shown in Figures 1 and 2 (having a hole 330 similar to the hole 30 and a valve 336 similar to the valve 36), and an intermediate portion 318 similar to the intermediate portion 18 shown in Figures 1 and 2. However, at the proximal end 314, the tubular member 312 includes a bent portion 360 that extends to the largest diameter portion of the helical cone shape 326. The helical cone shape 326 surrounds the tubular member 312 and extends toward the intermediate portion 318, and as the helical cone shape extends toward the intermediate portion 318, the diameter of the helical cone shape 326 decreases, and the first open end 328 of the stent 300 is at the substantially smallest diameter portion of the helical cone shape 326. In this embodiment, the conical spiral shape 326 is configured to lock its distal end in a predetermined position, and the apex of the conical spiral shape (i.e., the maximum diameter portion) allows for a spring action as ureteral contraction.

[0020] Referring again to Figure 10, another alternative embodiment of the proximal end is shown. The proximal end 414 is the spring region. (First conical region) 462 and anchor area (Second conical region)It includes a double conical spiral shape 426 having 464. Similar to the configuration shown in Figure 8, the tubular member 412 includes a bent portion 460. However, from the bent portion, the spring region 462 of the conical spiral shape increases away from the bent portion, and the maximum diameter portion of the helical cone shape 426 is located between the spring region 462 and the anchor region 464. The conical spiral shape 426 surrounds the tubular member 412 and extends toward the intermediate portion 418, and as the conical spiral shape extends from the spring region toward the intermediate portion 318, the diameter of the conical spiral shape 426 decreases, and the first open end 428 of the stent 400 is located in the substantially smallest diameter portion of the conical spiral shape 426.

[0021] According to various exemplary embodiments, the double conical spring shape may be provided with a heat-set fixture that includes two conical regions 562, 564 corresponding to regions 462, 464 of the conical spiral shape 426 (see Figure 11). However, it should be noted that the fixture shown in Figure 11 is merely illustrative, and any preferred type of fixture may be provided.

[0022] Referring again to Figure 12, another alternative embodiment of the proximal end is shown. Similar to the proximal end shown in Figure 8, the proximal end 614 includes a bent portion 660 and a first open end 628. However, in this embodiment, the proximal end 614 includes a coil-shaped portion 626 that is substantially located in a plane perpendicular to the intermediate portion 618 of the stent 600. The coil-shaped portion 626 surrounds the end of the tubular member 612 in a coil-like / spiral manner.

[0023] Referring again to Figure 13, another alternative embodiment of the proximal end is shown. Similar to the proximal end shown in Figure 8, the proximal end 714 includes a bent portion 760 and a first open end 728. However, in this embodiment, the proximal end 714 includes a coiled portion having a generally spherical or bulb-shaped portion 726. The coiled spherical or bulb-shaped portion 726 surrounds the end portion of the tubular member 712 of the stent 700.

[0024] Referring again to Figure 14, another embodiment of the stent is shown. In this embodiment, the stent 800 comprises a distal end 816 similar to the distal end 316 shown in Figure 8 (having a hole 830 similar to the hole 330 and a valve 836 similar to the valve 336), and an intermediate portion 818 similar to the intermediate portion 318 shown in Figure 8. However, at the proximal end 814, the helical cone shape 826 includes a reverse spiral (see Figure 16) compared to the configuration shown in Figure 8 (in other words, when viewed from above, the helix has a "clockwise" shape from the maximum diameter to the minimum diameter, whereas when viewed from above in the configuration of Figure 8, the helix has a "counterclockwise" shape from the maximum diameter to the minimum diameter). Furthermore, Figure 16 (see arrow) shows that the hole 830 is also provided on the inner surface of the conical helical shape 826 (i.e., the surface facing the tubular member 812). However, it should be noted that the holes 830 may be provided on any suitable surface portion of the conical spiral shape 826.

[0025] Figures 17–20 illustrate various exemplary embodiments of the external reflux skirt 34 (shown in Figure 4). However, the reflux skirts (or valves) 934, 934' are configured to act across the constricted portion of the tubular member 912, and in some embodiments, they are shortened. As the external valves 934, 934' are shortened, they spread out radially, creating a larger portion of the stent, thus blocking the flow of external fluid.

[0026] Figures 21 and 22 illustrate exemplary embodiments of the proximal portion 1014, which is configured to be adjustable to fit into the renal pelvis of various patients. However, it should be noted that the adjustable portion illustrated in Figures 21 and 22 may include any preferred configuration.

[0027] Any one or more technical effects of the exemplary embodiments provide significant advantages over conventional configurations having side holes punched or perforated through a wall, typically resulting in (multiple) pointed edges. The exemplary embodiments disclosed herein provide a smooth hole edge configuration (providing a smooth external port) that reduces patient pain and provides greater comfort.

[0028] The following provides a further description of various non-limiting exemplary embodiments. The exemplary embodiments described below may be carried out in conjunction with one or more other embodiments or exemplary embodiments. That is, as described immediately below, the exemplary embodiments of the present invention may be implemented, carried out or used in any combination (e.g., any preferred, practical, and / or executable combination), but are not limited to the combinations described herein and / or contained in the appended claims.

[0029] In one exemplary embodiment, a ureteral stent comprising a proximal end including a retaining mechanism having a coil shape, a distal end opposite to the proximal end, and an intermediate portion between the proximal and distal ends.

[0030] The ureteral stent, wherein the intermediate portion includes at least one opening having a smooth opening surface.

[0031] The ureteral stent having at least one opening with a rounded edge.

[0032] The coil shape is spiral, as described above for the ureteral stent.

[0033] The retaining mechanism is the ureteral stent, which has a conical coil shape.

[0034] The coil-shaped retaining mechanism of the ureteral stent is substantially located on a plane perpendicular to the plane in which the intermediate portion exists.

[0035] The retaining mechanism is a ureteral stent, which generally includes a spherical shape.

[0036] The ureteral stent comprises a tail portion configured to float at its distal end.

[0037] The retaining mechanism includes a double conical spiral shape, as described above for the ureteral stent.

[0038] The ureteral stent further comprises a one-way valve between the intermediate portion and the distal end.

[0039] The above-mentioned ureteral stent, further comprising a one-way valve at its distal end.

[0040] The distal end includes a retention mechanism, as described above, for the ureteral stent.

[0041] It should be understood that the components of the present invention can be connected or linked in operation, and that any number or any combination of intervening elements may exist (including no intervening elements). The connections may be direct or indirect, and furthermore, there may only be a mere functional relationship between the components.

[0042] It should be understood that the above description is merely illustrative of the present invention. Various alternatives and modifications can be devised by those skilled in the art without departing from the present invention. Accordingly, the present invention is intended to encompass all such alternatives, modifications, and variations that fall within the scope of the appended claims. [Explanation of Symbols]

[0043] 14,314,614,714,814 Proximal end, 16,316,816 Distal end, 18,318,418,618,818 Intermediate section, 26,326,426,626,726,826 Coil shape, 30 Opening, 32 Edge, 36 One-way valve, 40 Tail section, 42 One-way valve

Claims

1. It is a ureteral stent, A tubular member having a tubular structure extending along the entire length of the ureteral stent, comprising a tubular member (412) that starts from a first open end (428) of the tubular member and defines a lumen inside, the tubular member is It is configured to be positioned within the renal pelvis of the kidney and includes a proximal end (414) with a coil-shaped retaining mechanism, The distal end is located opposite the proximal end and is configured to be positioned within the bladder, The ureteral stent comprises an intermediate portion (418) located between the proximal end and the distal end, extending in the axial direction of the ureteral stent, The lumen is equipped with a one-way valve, The tubular member forms a portion at its proximal end that extends axially from the intermediate portion, and then, via a bent portion (460) at the end of the proximal end, extends in the direction of the intermediate portion so as to surround the extended portion, thereby forming the holding mechanism. The coil shape of the holding mechanism is a first conical region (462) located at the proximal end, having a spiral shape (426) that includes a first conical region (462) starting from the bent portion and a second conical region (464) that continues in the axial direction from the first conical region. The diameter of the first conical region increases as the first conical region extends axially from the bent portion toward the second conical region, and the maximum diameter portion of the spiral shape is formed in the first conical region, and The diameter of the second conical region decreases as the second conical region extends axially from the first conical region toward the intermediate portion, and the first open end of the tubular member is located at the distal end of the second conical region. Ureteral stent.

2. The ureteral stent according to claim 1, wherein the intermediate portion includes at least one opening having a smooth opening surface.

3. The ureteral stent according to claim 2, wherein the at least one opening includes a rounded edge.

4. The ureteral stent according to claim 1, wherein the distal end includes a tail portion configured to float.

5. The distal end includes a retaining mechanism, as described in claim 1.

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