Recyclable urethral support implant

Abstract

The application discloses a recyclable prostatic urethral support flow guide implant, which comprises, sequentially connected along a longitudinal direction, a slotted drainage pipe section, a flexible limiting wing group, a hollow support flow guide section, a local diameter increasing area, a smooth and tapered transition area, a flexible connecting part and a recycling ring; the flexible limiting wing group comprises a plurality of flexible wing plates arranged at intervals in a circumferential direction, each flexible wing plate has a wing root connected with an implant main body, and is contracted towards the longitudinal axis in a constrained state and is restored to be unfolded in a direction away from the longitudinal axis after the constraint is released; the maximum outer diameter of the local diameter increasing area is greater than that of its adjacent section and is smoothly connected through a gradual change surface; the cross-sectional outer contour of the flexible connecting part is smaller than that of the hollow support flow guide section; and the recycling part is arranged on the second end side of the flexible connecting part. The application can reduce low urethral irritation while stably supporting and increasing the drainage channel, is convenient for being compressed and placed through a sheath and being recycled, and reduces the complexity caused by multiple components.

Description

Technical Field

[0001] This invention relates to the field of interventional urological devices, and more specifically to a retrievable prostatic urethral support and drainage implant. Background Technology

[0002] Following benign prostatic hyperplasia (BPH) or minimally invasive treatments targeting the prostate, complications often include prostatic urethral compression, tissue edema, bloody discharge, or short-term difficulty urinating. Clinically, indwelling catheters are often used to establish a urinary pathway; however, external catheters and urine bags can reduce patient mobility and may cause urethral irritation.

[0003] Existing temporary prostatic urethral support devices typically employ tubular stents, dilatation frames, bellows-shaped inlets, and balloon anchoring to achieve positioning, support, and catheterization, with retrieval via a separate traction cable or extraction mechanism. However, these methods often utilize prominent convex rings or rigid steps to prevent axial migration; tubular stents and balloon anchoring require extensive contact and compression of the bladder wall, with tubular stents sometimes even crossing the membranous urethra or external sphincter region. All of these factors contribute to abnormal irritation and discomfort for patients, and most methods result in a small urine outlet, making passage restricted in the presence of small amounts of blood clots or debris. Separate traction cables or independent balloons also increase the number of components in the implant, complicating the implantation and retrieval process.

[0004] Therefore, how to develop a prostate urethral support and drainage implant with a stable support structure that reduces irritation, greater drainage capacity, and easy retraction is a technical problem that urgently needs to be solved. Summary of the Invention

[0005] Due to the aforementioned deficiencies in the existing technology, this invention proposes a retrievable prostate urethral support and drainage implant. The purpose is to reduce abnormal stimulation caused by the implant through structural design, increase the drainage channels for urine, blood clots or debris, and reduce the operational complexity caused by multiple components.

[0006] To achieve the above objectives, the present invention provides a retrievable prostatic urethral support and drainage implant, which is temporarily placed in the prostatic urethral region to maintain the urinary passage and can be recovered through the urethra. It has a longitudinal axis and includes a first slotted drainage tube segment, a flexible limiting wing group, a hollow support and drainage section, a local diameter-increasing area, a smooth tapering transition area, a flexible connecting part, and a recovery part, which are sequentially arranged and connected to each other along the longitudinal axis from a first end to a second end.

[0007] The flexible limiting wing assembly includes multiple flexible winglets spaced circumferentially, each winglet having a wing root connected to the implant body, and retracting towards the longitudinal axis under constrained conditions and unfolding away from the longitudinal axis after the constraint is released; the hollow support guide section forms a guide cavity communicating with the first slotted drainage pipe section; the maximum outer diameter of the local diameter-increasing zone is larger than its adjacent section and is smoothly connected by a gradient surface; the smooth tapering transition zone has rounded edges, and the cross-sectional size gradually decreases from the hollow support guide section to the flexible connection part;

[0008] The outer contour of the cross-section of the flexible connection is smaller than the outer contour of the cross-section of the hollow support guide section; the recycling part is disposed on the second end side of the flexible connection and forms a closed or non-closed ring structure that can be mechanically gripped.

[0009] The implant is inserted into the urethra after being encased in an insertion sheath. Once the flexible restraining wings, under restraint, have penetrated deep into the bladder, the insertion sheath is removed. At this point, the flexible wings of the restraining wings unfold, restraining the implant on the bladder side of the urethra. After implantation, the flexible restraining wings correspond to the bladder-side restraint area, the hollow support and guide section corresponds to the prostatic urethral support area, the low-profile flexible connecting portion corresponds to the membranous urethra and / or the area adjacent to the external sphincter, and the retrieval section is located at the second end of the hollow support and guide section to form an independent mechanical gripping point.

[0010] The above technical solutions achieve bladder-side flexible restraint through flexible restraint wings. Furthermore, a smooth, tapered transition zone and a low-profile flexible connector are used in the membranous urethra and adjacent areas of the external sphincter to reduce continuous radial expansion, thereby minimizing abnormal stimulation. This allows the external sphincter to more effectively close the urinary tract during involuntary urination, significantly reducing the chance of leakage. Patients can urinate independently without wearing a urinary bag, without affecting their normal social life. An integrated hollow drainage pathway preserves an auxiliary drainage channel for blood clots or debris. An integrated distal mechanical retrieval unit reduces the complexity associated with independent traction cables, balloons, or multi-component anchoring structures.

[0011] In some preferred embodiments, one or more second slotted drain pipe sections along the longitudinal axis are connected between the hollow support guide section and the smooth tapering transition zone to increase the inlet window and improve the drain volume.

[0012] In some preferred embodiments, the slotted drainage pipe section is hollow, with long slots cut into the pipe wall. The slots are spaced apart axially, staggered circumferentially, or both of the above arrangements are used simultaneously to further accelerate the drainage rate.

[0013] In some preferred embodiments, the first end of the first slotted drainage tube section is further provided with a non-invasive tip; the non-invasive tip is rounded, hemispherical, ellipsoidal or continuous arc shape, so as to reduce local irritation when it comes into contact with the bladder mucosa after entering the bladder.

[0014] In some preferred embodiments, the number of flexible winglets is two or more, and the multiple flexible winglets are spaced apart around the longitudinal axis to form a radially unfolding segmented limiting structure in a free state.

[0015] In some preferred embodiments, the wing root forms a flexible connection area, which has at least one of an arc transition, a gradual thickness, and a gradual width, in order to reduce local stress concentration when the flexible limiting wing retracts and expands.

[0016] In some preferred embodiments, the smooth tapering transition zone is provided with a through opening, which is teardrop-shaped, oblong, elliptical, or other elongated opening with rounded edges, to improve the flexibility of the smooth tapering transition zone and / or provide an auxiliary liquid passage.

[0017] In some preferred embodiments, the flexible connection is a flat strip structure with a cross-sectional width greater than its thickness and rounded or arc-shaped edges.

[0018] In some preferred embodiments, the recovery section is a recovery ring integrally connected to the flexible connecting section. When the recovery ring is pulled, the traction force is transmitted through the flexible connecting section and the smooth tapering transition zone to the hollow support guide section, so that the flexible winglets retract toward the longitudinal axis under constrained conditions and the entire implant is recovered.

[0019] In some preferred embodiments, at least the main body of the slotted drainage section, flexible limiting wing assembly, hollow support guide section, local diameter increasing zone, smooth tapering transition zone, flexible connection part, and recovery part is made of a biocompatible flexible polymer material, for example, at least one of medical silicone or thermoplastic polyurethane, so that the implant does not rely on a metal support skeleton to maintain the basic shape of the hollow support guide section.

[0020] Compared with the prior art, the technical effects of the present invention are as follows:

[0021] (1) The present invention uses a segmented flexible limiting wing instead of a large-volume balloon or rigid flared opening, which can form a foldable and recoverable low-volume limiting structure on the bladder side; the low-step flexible local diameter-increasing area improves the axial anti-migration ability through slight diameter increase and long-distance smooth transition, while reducing the scraping of the urethral mucosa by the abrupt steps; the low-profile flexible connecting band restricts the support function to the main segment of the prostatic urethra, so that the membranous part / external sphincter adjacent area mainly bears the flexible connection, which is conducive to reducing the continuous pressure on this area; the above-mentioned extreme flexible design not only reduces abnormal stimulation, but also allows the external sphincter to more effectively close the urinary tract passage when urinating involuntarily, greatly reducing the chance of urinary leakage, allowing patients to urinate involuntarily without wearing a urine bag, without affecting normal social life and life.

[0022] (2) The hollow support guide section and the slotted drainage pipe section of the present invention form a main channel and a lateral auxiliary channel, which provides an additional channel for urine discharge when a small amount of bloody secretions, flocculent matter or small blood clots appear.

[0023] (3) The integrated recovery ring of the present invention forms a dedicated mechanical gripping point, reducing independent traction lines, balloon anchoring or multi-component connectors, and improving the interface identifiability when retrieval.

[0024] (4) The present invention can be made of flexible polymer material. It can be constrained to a low profile state by inserting a sheath, and can be restored to the unfolded state of the limiting wing after the constraint is released. It is easy to operate and the patient feels comfortable. Attached Figure Description

[0025] The invention, its features, and advantages will become more apparent from the following detailed description of non-limiting embodiments with reference to the accompanying drawings. Like reference numerals denote like parts throughout the drawings. The drawings are not drawn to scale; their purpose is to illustrate the gist of the invention.

[0026] Figure 1 This is a three-dimensional structural schematic diagram of a prostate urethral support and drainage implant according to an embodiment of the present invention;

[0027] Figure 2 This is a front view of a prostate urethral support and drainage implant according to an embodiment of the present invention;

[0028] Figure 3 This is a top view of a prostate urethral support and drainage implant according to an embodiment of the present invention;

[0029] Figure 4 for Figure 1 Enlarged view of the front structure of the flexible connector;

[0030] Figure 5 This is a diagram showing the implantation position of a prostate urethral support and drainage implant according to an embodiment of the present invention.

[0031] Attached reference numerals: 1. First grooved drainage pipe section; 11. Non-invasive tip end;

[0032] 2. Flexible limiting wing assembly; 21. Flexible winglet; 22. Wing root;

[0033] 3. Hollow support guide section; 4. Local diameter increase zone; 41. Gradual surface;

[0034] 5. Smooth, tapering transition zone; 6. Flexible connection section; 7. Recovery section; 8. Second slotted drainage pipe section;

[0035] 9. Prostatic urethra; 10. Bladder base. Detailed Implementation

[0036] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. 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.

[0037] In the description of this application, it should be understood that the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Therefore, features defined as "first" or "second" may explicitly or implicitly include one or more of the stated features. In the description of this application, "multiple" means two or more, unless otherwise explicitly specified.

[0038] Example 1

[0039] See Figures 1 to 4 This embodiment discloses a retrievable prostatic urethral support and drainage implant with a longitudinal axis and defining a first end and a second end. The first end faces the bladder side in the implanted state, and the second end faces the external urethral orifice side. The implant includes a first slotted drainage tube segment 1, a flexible limiting wing assembly 2, a hollow support and drainage segment 3, a locally increasing diameter region 4, a smooth tapering transition region 5, a flexible connecting portion 6, and a retrievable portion 7, sequentially arranged and interconnected along the longitudinal axis from the first end to the second end. At least the main body of the above structure is made of a biocompatible flexible polymer material, for example, at least one of medical-grade silicone or thermoplastic polyurethane, so that the implant does not rely on a metal support skeleton to maintain the basic shape of the hollow support and drainage segment; each segment can be integrally molded, or multiple flexible structural segments can be connected to form a whole through processes such as heat sealing, thermoforming, or bonding.

[0040] The first end of the first slotted drainage tube section 1 is preferably provided with a non-invasive tip 11; the non-invasive tip 11 is blunt, hemispherical, ellipsoidal or continuous arc shape. For example, the non-invasive tip 11 adopts a continuous blunt shape to reduce local irritation when it comes into contact with the bladder mucosa after entering the bladder.

[0041] The flexible limiting wing assembly 2 is disposed between the first slotted drainage pipe section 1 and the hollow support guide section 3 or in the area connecting the two. It includes multiple flexible winglets 21 spaced circumferentially, each flexible winglet 21 having a wing root 22 connected to the implant body. Under constrained conditions, it retracts towards the longitudinal axis and unfolds away from the longitudinal axis after the constraint is released. For more details, see [link to relevant documentation]. Figure 4 The number of flexible winglets 21 is two or more, for example five. Multiple flexible winglets 21 are spaced apart around the longitudinal axis, forming a radially unfolding, segmented limiting structure in a free state. The wing root 22 constitutes a flexible connection area, which has at least one of the following characteristics: arc transition, gradual thickness, and gradual width.

[0042] The hollow support guide section 3 forms a guide cavity that communicates with the first slotted drainage pipe section 1. More specifically, the hollow support guide section 3 is a hollow flexible tubular structure with a guide cavity. The guide cavity is used to maintain the urinary channel during periods of pressure on the prostatic urethra or post-treatment edema. The wall thickness, outer diameter, and material hardness of the hollow support guide section 3 together form the support capacity against external pressure, without requiring a metal support frame. For example, the wall thickness of the hollow support guide section 3 is 0.5~0.7mm, the outer diameter is 6.0~6.4mm, and the hardness is 70~90A.

[0043] The maximum outer diameter of the local diameter-enhancing region 4 is slightly larger than that of its adjacent segments and is smoothly connected by a gradient surface 41, thereby increasing local contact and geometric damping without forming a rigid convex ring, which reduces the possibility of the implant migrating along the urethral axis.

[0044] The smooth, tapering transition zone 5 has rounded edges, and its cross-sectional size gradually decreases from the hollow support guide section 3 towards the flexible connection portion 6. The smooth, tapering transition zone 5 is provided with a through opening to improve local flexibility and also serve as an auxiliary liquid passage. The through opening is teardrop-shaped, oblong, elliptical, or other elongated opening with rounded edges. One or more second slotted drainage pipe sections 8 are also connected between the hollow support guide section 3 and the smooth, tapering transition zone 5 along the longitudinal axis. For example, the local diameter-increasing zone 4 can be slotted to serve as the second slotted drainage pipe section 8.

[0045] Preferably, the above-mentioned slotted drainage pipe section is hollow, and the pipe wall has long slots. The slots are spaced apart axially, staggered circumferentially, or both of the above arrangements are used simultaneously.

[0046] The outer contour of the cross-section of the flexible connecting part 6 is smaller than that of the hollow support and guide section 3. For example, the flexible connecting part 6 is a flat strip structure with a cross-sectional width greater than its thickness and rounded or arc-shaped edges. This structure passes through or is adjacent to the membranous urethra / external sphincter region in the intended implantation state, mainly serving the functions of connection and traction force transmission, rather than aiming to continuously radially expand the region.

[0047] The retrieval section 7 is disposed on the second end side of the flexible connecting section 6 and forms a closed or open ring structure that can be mechanically grasped. For example, the retrieval section 7 is a retrieval ring integrally or fixedly connected to the flexible connecting section 6. When the retrieval ring is pulled, the traction force is transmitted through the flexible connecting section 6 and the smooth tapering transition zone 5 to the hollow support guide section 3, so that the flexible wing 21 retracts towards the longitudinal axis under a constrained state and the entire implant is retrieved.

[0048] The implantation and retrieval process is as follows: The implant is encased in an insertion sheath, at which point the flexible limiting wing assembly 2 is restrained and retracted by the insertion sheath. The insertion sheath, along with the implant inside, is then inserted into the prostatic urethra 9. After the restrained flexible limiting wing assembly 2 has penetrated deep into the bladder, the insertion sheath is removed. At this point, the flexible wings of the flexible limiting wing assembly 2 are unrestrained and naturally unfold, securing the implant at the bladder base 10 in the urethra. See also... Figure 5 After implantation, the flexible limiting wing assembly 2 corresponds to the bladder-side limiting area, the hollow support and guiding section 3 corresponds to the prostatic urethral support area, the low-profile flexible connecting portion 6 corresponds to the membranous urethra and / or the area adjacent to the external sphincter, and the retrieval section 7 is located at the second end of the hollow support and guiding section to form an independent mechanical grasping point. When the retrieval section 7 is pulled to retrieve the implant, the traction force is transmitted through the flexible connecting portion 6 and the smooth tapering transition area 5 to the hollow support and guiding section 3, causing the flexible wing 21 to retract towards the longitudinal axis under a constrained state and retrieve the entire implant. The above anatomical division relationship is only used to illustrate the expected spatial fit of the structure and does not constitute a procedure for disease treatment. For example, the flexible limiting wing assembly 2 can be accommodated in an insertion sheath with an inner diameter of approximately 6.4 mm after retraction. For other models, the outer diameter, length, and size of the limiting wings of the hollow support and guiding section 3 can be adjusted according to the patient's anatomy and product specifications, as long as the structural combination relationship defined in this application is maintained.

[0049] Example 2

[0050] This embodiment discloses a retrievable prostatic urethral support and drainage implant, whose structure and usage are similar to those of Embodiment 1. More specifically, the flexible flaps 21 can be three, four, five, six, or other quantities, and can adopt fan-shaped, leaf-shaped, curved, arc-shaped, or other flexible sheet-like structures with rounded free ends. Different flexible flaps 21 can be circumferentially distributed at equal or non-equal angles, as long as they can form bladder-side restraint after the constraint is released and can retract back towards the axial direction during retrieval.

[0051] Example 3

[0052] This embodiment discloses a retrievable prostatic urethral support and drainage implant, the structure and usage of which are similar to those of Embodiment 1. More specifically, multiple slotted drainage tube segments may have the same or different lengths, widths, and circumferential angles. All opening edges that come into contact with urine or tissue preferably have rounded corners.

[0053] Example 4

[0054] This embodiment discloses a retrievable prostatic urethral support and drainage implant, whose structure and usage are similar to those of Embodiment 1. More specifically, the local diameter-enlarging region 4 can be a single continuous diameter-enlarging segment, or two or more smoothly spaced diameter-enlarging segments along the axial direction. Its outer contour can be a combination of cylinder-cone-cylinder, a gently curved drum shape, a circular arc protrusion shape, or other continuous curved surfaces without sharp vertical steps.

[0055] Example 5

[0056] This embodiment discloses a retrievable prostatic urethral support and drainage implant, whose structure and usage are similar to those of Embodiment 1. More specifically, the low-profile flexible connecting portion can be elliptical, rounded rectangular, biconvex lens shaped, or other low-profile cross-sections with a width greater than its thickness. Preferably, its target cross-section can be approximately 0.5 mm × 1.2 mm; this specific dimension is only an embodiment and does not limit the scope of protection of the present invention.

[0057] Those skilled in the art should understand that variations can be implemented by combining existing technology with the above embodiments, which will not be elaborated here. Such variations do not affect the essence of the present invention, and will not be elaborated here either.

[0058] The preferred embodiments of the present invention have been described above. It should be understood that the present invention is not limited to the specific embodiments described above, and the devices and structures not described in detail should be understood as being implemented in a conventional manner in the art. Any person skilled in the art can make many possible variations and modifications to the technical solutions of the present invention using the methods and techniques disclosed above, or modify them into equivalent embodiments with equivalent changes, without departing from the scope of the present invention. This does not affect the essential content of the present invention. Therefore, any simple modifications, equivalent changes, and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the present invention's technical solutions still fall within the protection scope of the present invention.

Claims

1. A retrievable prostatic urethral support and drainage implant, temporarily placed in the prostatic urethral region to maintain the urinary pathway and retrievable via the urethra, characterized in that, It has a longitudinal axis and includes a first slotted drain pipe section (1), a flexible limiting wing group (2), a hollow support guide section (3), a local diameter increasing zone (4), a smooth tapering transition zone (5), a flexible connection part (6), and a recovery part (7) arranged sequentially from the first end to the second end along the longitudinal axis and connected to each other. The flexible limiting wing assembly (2) includes a plurality of flexible winglets (21) spaced apart along the circumference. Each flexible winglet (21) has a wing root (22) connected to the implant body and retracts toward the longitudinal axis under constrained conditions and unfolds away from the longitudinal axis after the constraint is released. The hollow support guide section (3) forms a guide cavity that communicates with the first slotted drain pipe section (1). The maximum outer diameter of the local diameter-increasing region (4) is greater than that of its adjacent section and is smoothly connected by a gradient surface (41). The smooth tapering transition region (5) has rounded edges and gradually decreases in cross-sectional size from the hollow support guide section (3) to the flexible connecting part (6). The outer contour of the cross-section of the flexible connecting part (6) is smaller than the outer contour of the cross-section of the hollow support guide section (3); the recycling part (7) is disposed on the second end side of the flexible connecting part (6) and forms a closed or non-closed ring structure that can be mechanically gripped.

2. The retrievable prostatic urethral support and drainage implant according to claim 1, characterized in that, One or more second slotted drain pipe sections (8) along the longitudinal axis are also connected between the hollow support guide section (3) and the smooth tapering transition zone (5).

3. A retrievable prostatic urethral support and drainage implant according to claim 1 or 2, characterized in that, The slotted drainage pipe section is hollow, with long slots cut into the pipe wall. The slots are spaced apart axially, staggered circumferentially, or both of the above arrangements are used simultaneously.

4. A retrievable prostatic urethral support and drainage implant according to claim 1 or 2, characterized in that, The first end of the first slotted drainage pipe section (1) is also provided with a non-invasive end (11); the non-invasive end (11) is rounded, hemispherical, ellipsoidal or continuous arc shape.

5. A retrievable prostatic urethral support and drainage implant according to claim 1 or 2, characterized in that, The number of flexible winglets (21) is two or more, and the multiple flexible winglets (21) are arranged at intervals around the longitudinal axis to form a radially unfolding segmented limiting structure in a free state.

6. A retrievable prostatic urethral support and drainage implant according to claim 5, characterized in that, The wing root (22) forms a flexible connection area, which has at least one of the following: arc transition, gradual thickness, and gradual width.

7. The retrievable prostatic urethral support and drainage implant according to claim 1 or 2, characterized in that, The smooth tapering transition area (5) is provided with a through opening, which is a teardrop-shaped, oblong, elliptical or other elongated opening with rounded edges.

8. The retrievable prostatic urethral support and drainage implant according to claim 1 or 2, characterized in that, The flexible connecting part (6) is a flat strip structure with a cross-sectional width greater than its thickness and rounded or arc-shaped edges.

9. The retrievable prostatic urethral support and drainage implant according to claim 1 or 2, characterized in that, The recovery section (7) is a recovery ring integrally connected with the flexible connection section (6). When the recovery ring is pulled, the traction force is transmitted to the hollow support guide section (3) through the flexible connection section (6) and the smooth tapering transition area (5), so that the flexible wing (21) retracts towards the longitudinal axis under the constraint state and recovers the entire implant.

10. The retrievable prostatic urethral support and drainage implant according to claim 1 or 2, characterized in that, At least the main body of the slotted drainage pipe section, the flexible limiting wing group (2), the hollow support guide section (3), the local diameter increasing zone (4), the smooth tapering transition zone (5), the flexible connection part (6), and the recovery part (7) is made of biocompatible flexible polymer material.

Images