An extruded urethral closure device

Abstract

The application provides an extrusion type urethral closure device, and relates to the technical field of urethral closure, which comprises an elastic closed loop body, the elastic closed loop body is an elliptical ring, the elastic closed loop body is used for being implanted into a deep fascia of a penis and being sleeved with a penis body, a convex part is arranged on the inner wall of one side of the elastic closed loop body in the direction of a short axis, the convex part is used for corresponding to a urethra and pressing the urethra to make the urethra closed, two suture holes are arranged on the side opposite to the convex part of the elastic closed loop body, and the suture holes are used for suture fixing the elastic closed loop body between the deep fascia and a tunica albuginea through a suture line; the problems that there is no completely self-sufficient implantable urethral closure scheme in the prior art, and the existing urethral closure device is complex in structure and complicated in operation are solved.

Description

Technical Field

[0001] This invention belongs to the field of urethral closure technology, and more specifically, relates to a compression-type urethral closure device. Background Technology

[0002] Male urinary incontinence can be classified into mild, moderate, and severe based on the degree of leakage. Patients with different degrees exhibit significant differences in leakage frequency, leakage volume, and the extent of limitations in daily life, and their needs for urethral closure also vary accordingly. Epidemiological studies show that male urinary incontinence is highly prevalent in the elderly, with a prevalence rate of 11%–34% in men over 65 years of age. Sphincter dysfunction-related urinary incontinence following radical prostatectomy or transurethral resection of the prostate (TURP) is the main cause. Notably, a higher proportion of elderly patients who have undergone these surgeries also experience erectile dysfunction (ED); the reported incidence of ED after radical prostatectomy can reach 40%–80%. These patients no longer have a real need for sexual activity, and their core treatment goal is to effectively restore urinary control and improve confidence in daily activities, rather than preserving sexual function. This group constitutes a specific patient population that prioritizes effective urinary control and has a higher acceptance of the impact on sexual function.

[0003] The AMS 800 artificial urethral sphincter system, currently considered the "gold standard" for clinical urinary control, achieves urinary control through urethral compression via a hydraulic cuff, theoretically applicable to all degrees of sphincter dysfunction. However, its main limitation lies in its operational complexity: patients must repeatedly squeeze the hydraulic control pump within the scrotum and wait for the fluid to transfer between the pump, reservoir, and cuff before urination can occur. This process demands a high level of fine motor skill. In elderly patients, conditions such as arthritis, Parkinson's disease, and sequelae of cerebrovascular disease leading to decreased hand dexterity are extremely common, resulting in a significant proportion of patients struggling to operate the pump independently, severely impacting the system's effectiveness and the patient's ability to urinate independently. Furthermore, the long-term mechanical failure rate of the AMS 800 system's multi-component hydraulic structure and the resulting risk of revision surgery also increase the patient's medical burden.

[0004] In the research direction of simplifying operation, existing technologies have not been able to get rid of the dependence on external auxiliary devices. The magnetic closure scheme disclosed in publication number CN101001586B requires an external magnetic repulsion device to relieve pressure during urination; the magnetohydrodynamic valve device disclosed in publication number CN114712030B also requires an external magnetic field excitation device as a driving source. Although this type of "internal implantation with external drive" scheme simplifies the implant structure, it still requires patients to carry and operate external devices, which also poses a usage obstacle for elderly patients with poor hand function. To date, there is no completely self-contained implantable scheme, that is, one that can achieve urination control with only simple skin pressure without any external devices, suitable for male urinary incontinence of all degrees from mild to severe. Summary of the Invention

[0005] The purpose of this invention is to address the shortcomings of existing technologies by providing a compression-type urethral closure device, which solves the problem that the lack of a fully self-sufficient implantable urethral closure solution in existing technologies leads to complex structures and cumbersome operations in existing urethral closure devices.

[0006] To achieve the above objectives, the present invention provides a compression-type urethral closure device, comprising: An elastic closed-loop body, which is an elliptical ring, is used to be implanted into the deep fascia of the penis and fits onto the penile body. A protrusion is provided on the inner wall of one side along the short axis of the elastic closed-loop body. This protrusion corresponds to the urethra and compresses the urethra directly below it to close it. Two suture holes are provided on the side of the elastic closed-loop body opposite to the protrusion. These suture holes are used to suture and fix the elastic closed-loop body between the deep fascia and the tunica albuginea using sutures.

[0007] Optionally, the major axis of the elastic closed-loop body is 4.5-5.5cm, the minor axis is 3-4cm, the circumference is 7.8±0.7cm, the width is 1-1.5cm, and the thickness is 0.5-1mm.

[0008] Optionally, the material of the elastic closed-loop body is a medical-grade superelastic nickel-titanium alloy.

[0009] Optionally, the diameter of the suture hole is 0.2-0.5 mm.

[0010] Optionally, the inner wall of the elastic closed-loop body on the other side in the short axis direction is provided with two protruding compression parts.

[0011] Optionally, the compression portion covers the suture hole.

[0012] Optionally, the material of the protrusion is a composite material of medical silicone rubber and hydrophilic hydrogel.

[0013] Optionally, the material of the compression part is a composite material of medical silicone rubber and hydrophilic hydrogel.

[0014] Optionally, the root diameter of the protrusion is 5-7 mm, and the protrusion height is 1.5-2 mm.

[0015] Optionally, the pressure exerted by the protrusion on the urethra is 40-60 cmH2O. Under the compression state along the long axis of the elastic closed-loop body, the protrusion moves away from the urethra so that the pressure does not exceed 10 cmH2O.

[0016] This invention provides a compression-type urethral closure device, the advantages of which are as follows: This compression-type urethral closure device uses an elastic closed-loop body implanted in the deep fascia of the penis. With the suture thread passing through the suture hole to fix the elastic closed-loop body between the deep fascia and the tunica albuginea, through its elliptical ring design and its connection with the penile body, its elasticity allows the protrusion to compress the urethra directly below it in a resting state, thus compressing the urethra and achieving passive urinary control without any external instruments or operations. This greatly simplifies the structure of the implanted component and eliminates all external components and operations, achieving a completely self-sufficient implantable urethral closure solution. When urination is required, the patient only needs to pinch the sides of the penis with their fingers to compress the elliptical ring elastic closed-loop body along its long axis. When squeezed, the elastic closed-loop body tends to deform into a round shape, causing the protrusion to shift away from the urethra, relieving pressure on the urethra and allowing urine to flow out. After releasing the pressure, the elastic closed-loop body returns to its original position, and the urethral closure function is automatically restored. This operation requires minimal movement and limited pinching force, and can be performed independently even by elderly patients with reduced fine motor skills. However, since the elastic closed-loop body is installed around the penile shaft, long-term pressure can affect the engorgement function of the corpora cavernosa. Therefore, this device is mainly suitable for patients who prioritize the restoration of urinary control and do not require the preservation of sexual function, providing this group with a new type of urinary control solution that is simple in structure, completely self-sufficient, and adaptable to various degrees of condition.

[0017] Other features and advantages of the present invention will be described in detail in the following detailed description section. Attached Figure Description

[0018] The above and other objects, features and advantages of the present invention will become more apparent from the more detailed description of exemplary embodiments of the invention in conjunction with the accompanying drawings, wherein the same reference numerals generally represent the same components in the exemplary embodiments of the invention.

[0019] Figure 1 A front view schematic diagram of a compression-type urethral closure device according to an embodiment of the present invention is shown.

[0020] Figure 2A side view of a squeeze-type urethral closure device according to an embodiment of the present invention is shown.

[0021] Figure 3 A top view schematic diagram of a compression-type urethral closure device according to an embodiment of the present invention is shown.

[0022] Explanation of reference numerals in the attached figures: 1. Elastic closed-loop body; 2. Protrusion; 3. Seam hole; 4. Compression part. Detailed Implementation

[0023] Preferred embodiments of the invention will now be described in more detail. While preferred embodiments of the invention are described below, it should be understood that the invention can be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that the invention will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.

[0024] like Figures 1 to 3 As shown, the present invention provides a squeeze-type urethral closure device, comprising: The elastic closed-loop body 1 is an elliptical ring. It is used to be implanted into the deep fascia of the penis and fits into the penile body. A protrusion 2 is provided on the inner wall of one side of the elastic closed-loop body 1 along its short axis. The protrusion 2 is used to correspond to the urethra and compress the urethra directly below it to close the urethra. Two suture holes 3 are provided on the side of the elastic closed-loop body 1 opposite to the protrusion 2. The suture holes 3 are used to suture and fix the elastic closed-loop body 1 between the deep fascia and the tunica albuginea through sutures.

[0025] Specifically, to address the lack of a fully self-sufficient implantable urethral closure solution in existing technologies, which leads to the complexity and cumbersome operation of current urethral closure devices, this invention provides a compression-type urethral closure device. An elastic closed-loop body 1 is implanted within the deep fascia of the penis. With sutures passing through suture holes 3 to fix the elastic closed-loop body 1 between the deep fascia and the tunica albuginea, its elliptical ring design and its connection to the penile body utilize its elasticity to compress the urethra from directly below in a resting state, causing the urethra to collapse. This achieves passive urinary control without any external instruments or manipulation, drastically simplifying the implanted component's structure and eliminating all external parts and operations, resulting in a fully self-sufficient implantable urethral closure solution. When urination is needed, the patient only needs to pinch the sides of the penis with their fingers. The elliptical, ring-shaped elastic closed-loop body 1 is compressed along its long axis, causing it to deform into a rounder shape. This displaces the protrusion 2 away from the urethra, relieving pressure on the urethra and allowing urine to drain. Upon release, the elastic closed-loop body 1 returns to its original position due to its elasticity, automatically restoring urethral closure. This operation requires minimal movement and limited force, making it easy for elderly patients with diminished fine motor skills to perform independently. Furthermore, because the elastic closed-loop body 1 is installed around the penile shaft, long-term compression can affect the engorgement function of the corpora cavernosa. Therefore, this device is primarily suitable for patients prioritizing urinary control and not requiring preservation of sexual function, providing a simple, self-sufficient, and adaptable novel urinary control solution for this group.

[0026] Optionally, the major axis of the elastic closed-loop body 1 is 4.5-5.5cm, the minor axis is 3-4cm, the circumference is 7.8±0.7cm, the width is 1-1.5cm, and the thickness is 0.5-1mm.

[0027] Specifically, the elastic closed-loop body 1 is fitted on the outside of the penile body and matches the size of the penile body. Its elliptical shape allows the protrusion 2 to provide a set pressure on the urethra in a non-stressed state, ensuring the closure of the urethra.

[0028] Optionally, the material of the elastic closed-loop body 1 is a medical-grade superelastic nickel-titanium alloy.

[0029] Specifically, medical-grade superelastic nickel-titanium alloy is a nickel-titanium shape memory alloy (NiTi), which is a shape memory alloy based on near-equal atomic ratio nickel and titanium. At body temperature (37°C), it exists in the austenitic phase and exhibits outstanding superelastic characteristics: its recoverable elastic strain is as high as 8%–10%, far exceeding that of ordinary medical stainless steel (approximately 0.2%). After deformation under external force, it automatically recovers its shape upon removal of the load and maintains stable mechanical properties through more than 100,000 fatigue cycles. NiTi alloy has passed the ISO 10993 series of biocompatibility assessments and has decades of mature clinical application records in vascular stents, dental archwires, and orthopedic implants. Furthermore, the cross-sectional shape of NiTi alloy can be precisely set through heat treatment, thereby achieving quantitative design of elastic recovery force in specific directions. These characteristics make it an ideal material basis for constructing repeatable deformation, self-resetting urethral closure devices.

[0030] Optionally, the diameter of the suture hole 3 is 0.2-0.5 mm.

[0031] Specifically, the suture hole 3 is provided for the suture thread to pass through, thereby anchoring the elastic closed-loop body 1.

[0032] Optionally, two protruding compression parts 4 are provided on the inner wall of the other side in the short axis direction of the elastic closed-loop body 1.

[0033] Specifically, the two compression parts 4 are arranged opposite to the protrusion 2 and are symmetrically distributed on both sides of the short axis, cooperating with the protrusion 2 to ensure the compression effect on the urethra.

[0034] Optionally, the compression portion 4 covers the suture hole 3.

[0035] Specifically, two compression parts 4 are respectively set on two suture holes 3 to cover the suture holes 3. When suturing, the suture thread passes through the compression parts 4 and through the suture holes 3, which can reduce the wear of the tissue around the suture holes 3 and the suture thread.

[0036] Optionally, the material of the protrusion 2 is a composite material of medical silicone rubber and hydrophilic hydrogel.

[0037] Specifically, medical silicone rubber is mixed with hydrophilic hydrogel and medical vulcanizing machine in a set ratio, and then vulcanized at high temperature in a mold to form protrusion 2.

[0038] Optionally, the compression part 4 is made of a composite material of medical silicone rubber and hydrophilic hydrogel.

[0039] Specifically, the structure of the compression part 4 is similar to that of the protrusion part 2, and both can be fixed to the inner wall of the elastic closed-loop body 1 by adhesive bonding.

[0040] Optionally, the root diameter of the protrusion 2 is 5-7 mm, and the protrusion height is 1.5-2 mm.

[0041] Specifically, the size of the protrusion 2 is matched with the size of the urethra to ensure that the urethra can be gently compressed when not under force, so as to promote the urethra to close.

[0042] Optionally, the pressure exerted by the protrusion 2 on the urethra is 40-60 cmH2O. Under the compression state along the long axis of the elastic closed-loop body 1, the protrusion 2 moves away from the urethra so that the pressure does not exceed 10 cmH2O.

[0043] Specifically, two anchoring points are formed at the two suture holes 3. Under the action of the two anchoring points, the elastic closed-loop body 1 in the non-stressed state can achieve appropriate pressure on the urethra through the protrusion 2, so as to achieve the closure of the urethra. When the elastic closed-loop body 1 on the penis is squeezed along the long axis, the protrusion 2 moves outward through elastic deformation, thereby relieving the pressure on the urethra.

[0044] In this embodiment, the compression-type urethral closure device provided by the present invention is prepared as follows: Preparation of elastic closed-loop body 1: (1) Raw materials: Medical-grade superelastic nickel-titanium alloy; (2) Surface pretreatment: ultrasonic degreasing with anhydrous ethanol, removal of oxide layer with 5% dilute nitric acid, rinsing with ultrapure water, and vacuum drying; (3) Molding: A custom elliptical core mold (major axis 5.0cm, minor axis 3.5cm, width 1.0cm) is formed by isostatic pressing; (4) Welding and sealing: Laser micro-welding is used to weld and seal the joint to form a complete elliptical closed loop; (5) Low temperature annealing: vacuum annealing furnace, 320℃ for 15 min, then cooled to room temperature with the furnace to eliminate internal stress and optimize superelasticity; (6) Finishing: Grind the weld seam, and laser drill two 0.5mm diameter stitching holes in the upper left and upper right corners.

[0045] Preparation of protrusion 2 and compression part 4: (1) Gel preparation: Add medical silicone rubber, recombinant human collagen and medical vulcanizing agent in proportion, and stir mechanically until uniform; (2) Molding: Inject into the upper fixed point mold and the lower protrusion mold (inferior spherical mold), vulcanize at 135℃ and 0.4MPa for 25min, and demold; (3) Bonding and fixing: The soft gel component is bonded to the corresponding position of the elastic closed ring 1 with medical adhesive and then pressed under high temperature and high pressure; (4) Sterilization treatment: γ-ray sterilization, aseptic double-layer packaging, shelf life of 3 years.

[0046] The surgical implantation procedure includes: (1) Anesthesia position: The patient is placed in a supine position and local anesthesia is administered; (2) Surgical incision: Penile circumcision, cut open the skin and subcutaneous tissue to expose the superficial fascia, and dissect along the gap to expose the deep penile fascia; (3) Space preparation: Bluntly dissect the annular space between the deep fascia and the tunica albuginea (be careful to avoid damaging the dorsal neurovascular bundle). (4) Device insertion: Insert the elastic closed-loop body 1 through the incision and place it between the deep fascia and the tunica albuginea. Adjust it so that the lower protrusion 2 is directly below the corpus spongiosum. Confirm the position of the upper compression part 4 and the suture hole 3. (5) Suture fixation: Use absorbable sutures to pass through the compression part 4 and the suture hole 3, and fix them to the deep fascia with 2 sutures each; (6) Close the incision: Suture the superficial fascia, subcutaneous tissue and skin layer by layer, bandage with sterile dressing, and remove the sutures 3-5 days after the operation.

[0047] The daily usage method is as follows: Urine-holding state: After the elastic closed-loop body 1 is implanted, it normally remains oval in shape. The protruding part 2 at the lower end continuously applies a mild pressure of 40-60 cmH2O to the urethral sponge, and the urethra closes. The patient can passively hold urine without any operation.

[0048] Urinary control: The patient applies mild pressure from both sides of the penis with both hands simultaneously. Under the stress-induced martensitic phase transformation, the elastic closed-loop body 1 quickly deforms from an elliptical shape to a circular shape. The lower protrusion 2 then expands outward and moves away from the urethra. The urethral pressure drops to ≤10cmH2O, the urethra opens, and normal urination can occur. After urination, the patient releases both hands, and the elastic closed-loop body 1 instantly returns to an elliptical shape (reset time ≤0.3s). The protrusion 2 then re-presses the urethra, restoring closure.

[0049] Key points of operation: The squeezing direction is to the left and right sides of the penis; maintain the squeezing until urination is complete and then release; the operating force does not need to be precisely controlled (elastic force <1N can trigger deformation).

[0050] Compared to traditional implantable urethral closure devices, this squeeze-type urethral closure device: (1) The surgery is less invasive, with a mature circumcision incision that does not require intrusion into the urethra, and recovery takes 3-5 days post-surgery; the circumference of 7.8±0.7cm covers the mainstream adult size. (2) The operation is extremely simple and requires no external equipment: urination is triggered by squeezing both sides of the penis with your hand. It lasts for ≤10 seconds and automatically resets when you release it. Elderly patients can complete this independently. (3) The compression pressure is precise and controllable: 40-60 cmH2O under normal conditions, ≤10 cmH2O after compression, and the soft gel protrusions prevent direct metal friction against the tissue; (4) Reliable fixation: The deep fascia is anchored by double-point sutures, and there is no displacement after 100,000 deformations; (5) Excellent fatigue resistance: The superelastic nickel-titanium alloy has a deformation of ≥100,000 times, a recovery rate of ≥99%, and a service life of ≥5 years; (6) Simple structure and low maintenance cost: No precision components such as magnetic fluid and motor are required, and no daily maintenance is needed.

[0051] The various embodiments of the present invention have been described above. These descriptions are exemplary and not exhaustive, nor are they limited to the disclosed embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments.

Claims

1. A compression-type urethral closure device, characterized in that, include: An elastic closed-loop body, which is an elliptical ring, is used to be implanted into the deep fascia of the penis and fits onto the penile body. A protrusion is provided on the inner wall of one side along the short axis of the elastic closed-loop body. This protrusion corresponds to the urethra and compresses the urethra directly below it to close it. Two suture holes are provided on the side of the elastic closed-loop body opposite to the protrusion. These suture holes are used to suture and fix the elastic closed-loop body between the deep fascia and the tunica albuginea using sutures.

2. The compression-type urethral closure device according to claim 1, characterized in that, The elastic closed-loop body has a major axis of 4.5-5.5cm, a minor axis of 3-4cm, a circumference of 7.8±0.7cm, a width of 1-1.5cm, and a thickness of 0.5-1mm.

3. The compression-type urethral closure device according to claim 1, characterized in that, The material of the elastic closed-loop body is a medical-grade superelastic nickel-titanium alloy.

4. The compression-type urethral closure device according to claim 1, characterized in that, The diameter of the suture hole is 0.2-0.5 mm.

5. The compression-type urethral closure device according to claim 1, characterized in that, The inner wall of the elastic closed-loop body on the other side in the direction of the short axis is provided with two protruding compression parts.

6. The compression-type urethral closure device according to claim 5, characterized in that, The compression portion covers the suture hole.

7. The compression-type urethral closure device according to claim 1, characterized in that, The material of the protrusion is a composite material of medical silicone rubber and hydrophilic hydrogel.

8. The compression-type urethral closure device according to claim 6, characterized in that, The compression part is made of a composite material of medical silicone rubber and hydrophilic hydrogel.

9. The compression-type urethral closure device according to claim 1, characterized in that, The root diameter of the protrusion is 5-7 mm, and the protrusion height is 1.5-2 mm.

10. The compression-type urethral closure device according to claim 1, characterized in that, The pressure exerted by the protrusion on the urethra is 40-60 cmH2O. Under the compression state along the long axis of the elastic closed-loop body, the protrusion moves away from the urethra so that the pressure does not exceed 10 cmH2O.

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