A soft dilating device for the prepuce of a child

Abstract

The application discloses a soft expanding device for adapting to foreskin orifice of children, and belongs to the technical field of medical devices, which comprises a handheld tube, a plurality of expansion petals for softly expanding foreskin orifice of children are rotationally connected to the top end of the handheld tube, the expansion petals adopt a segmented elastic hinged structure and are divided into a root connecting section, a middle elastic deformation section and an end expansion section, a thin elastic steel sheet capable of realizing small-angle self-adaptive fine adjustment is arranged in the middle elastic deformation section, the soft expanding device is adapted to tightness and contour radian of foreskin orifice of different children, an arc-shaped rod is connected to the outer side wall of the expansion petals, the two ends of the arc-shaped rod are configured as hemispherical surfaces, and the radian of the arc-shaped rod is matched with the natural physiological radian of foreskin orifice of children. The soft expanding device for adapting to foreskin orifice of children is high in stability after adjustment, has the advantages of operation safety, expansion accuracy, function integration and use stability, and is highly adapted to the non-invasive expansion nursing requirement of delicate tissues of the reproductive parts of children.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, and in particular to a gentle dilator for the foreskin opening of children. Background Technology

[0002] Phimosis is a common condition in children. In children, phimosis occurs because the foreskin opening is narrow or the foreskin is adhered to the glans penis, preventing the foreskin from being retracted to expose the urethral opening and glans. Current treatments for phimosis mainly include circumcision and foreskin dilation surgery. Circumcision inevitably causes trauma to the patient, as it involves the use of dilation devices. However, traditional dilation devices lack a locking function when manually adjusted, which affects the accuracy of dilation and subsequent procedures. Furthermore, the fixation effect is generally poor, and unexpected movement of the dilation flap can also affect the safety of dilation and subsequent procedures.

[0003] Chinese patent document (application publication number CN111973238A) discloses a genital foreskin dilator, comprising: a gripping part; multiple dilating flaps arranged around the gripping part, the flaps extending gradually inward away from the gripping part; and an adjusting device arranged on the gripping part for adjusting the dilating angle of the multiple dilating flaps to accommodate different degrees of phimosis. Applying this genital foreskin dilator, the dilating diameter of the foreskin opening can be flexibly adjusted according to the degree of phimosis and the treatment needs of each dilution. Repeated use can effectively reduce patient discomfort and improve treatment compliance in children. It has advantages such as adjustable dilating force, balanced dilating surface, stable dilating force support, convenient use, and a lightweight and simple structure. However, the dilator in the aforementioned patent lacks a locking function during manual adjustment, which affects the accuracy of dilution and subsequent operations. Furthermore, the fixation effect is generally poor, and accidental movement of the dilating flaps can also affect the safety of dilution and subsequent operations. Summary of the Invention

[0004] The purpose of this invention is to provide a gentle dilator for the foreskin opening of children, in order to solve the problems mentioned in the background art.

[0005] To achieve the above objectives, the present invention provides the following technical solution: a gentle dilator for the foreskin opening of children, comprising:

[0006] The handheld tube has multiple expansion flaps rotatably connected to its tip for gently widening the foreskin opening in children. These expansion flaps employ a segmented, elastically hinged structure, consisting of a root connection segment, a middle elastic deformation segment, and an end expansion segment. The middle elastic deformation segment contains a thin, elastic steel sheet capable of small-angle adaptive micro-adjustment, adapting to different tightness and curvature of the foreskin opening in children. An arc-shaped rod is connected to the outer wall of the expansion flap; both ends of the arc-shaped rod are hemispherical, and the curvature of the rod matches the natural physiological curvature of the child's foreskin opening. When the multiple expansion petals are fully retracted, they are spliced ​​together to form a tapered, closed funnel-shaped structure without sharp gaps. When the multiple arc-shaped rods retract synchronously, they enclose to form a regular and smooth circular limiting structure, which facilitates the insertion of the instrument into the foreskin opening without damage. The outer diameter of the circular structure formed when the arc-shaped rods retract is larger than the inner diameter of the top of the funnel-shaped structure formed when the expansion petals retract, forming an end limiting and protective structure, which can effectively prevent the expansion petals from extending too far, accurately limit the insertion depth, and prevent mucosal damage caused by excessive operation.

[0007] An insertion rod is set inside the handheld tube. The top of the insertion rod is connected to a hemispherical shell for pushing the expansion petals to rotate outward. The outer spherical surface of the hemispherical shell is completely fitted and matched with the inner sidewalls of multiple expansion petals. The expansion petals are made of iron material. An electromagnet for attracting and fixing the expansion petals is installed on the inner wall of the hemispherical shell.

[0008] An internally threaded rod is located inside the handheld tube. The inner wall of the handheld tube has an internal thread that is threaded to the internally threaded rod. An adjusting electric actuator is detachably connected to the side of the internally threaded rod near the expansion flap. The moving part of the adjusting electric actuator is connected and fixed to the insertion rod.

[0009] As a preferred embodiment, the outer periphery of the handheld tube is detachably connected to an anti-slip soft rubber pad that facilitates hand gripping. The outer periphery of the anti-slip soft rubber pad is integrally injection molded with multiple gripping protrusions that are adapted to the gripping posture of the fingers.

[0010] As a preferred embodiment, multiple low-frequency red light therapy lamps for physiotherapy are embedded in the outer periphery of the insertion rod and the hemispherical shell. The light irradiation angle is directed towards the foreskin opening expansion and contact area, which can simultaneously achieve local anti-inflammatory and soothing of redness and swelling during the expansion process, reducing the discomfort of expansion.

[0011] As a preferred embodiment, both the expansion flap and the arc-shaped rod are detachably connected to a flexible medical silicone adhesive layer on their outer periphery, and the outer wall structure of the flexible medical silicone adhesive layer is an arc-shaped curved surface that conforms to the foreskin.

[0012] As a preferred embodiment, multiple pressure sensing modules are installed between the expansion valve and the flexible medical silicone adhesive layer, and a drug release groove for temporarily placing drugs is opened on the outer periphery of the flexible medical silicone adhesive layer.

[0013] As a preferred embodiment, the outer side of the drug release tank is detachably snapped with a microporous sustained-release membrane for sealing the drug dosage and releasing it at a uniform rate. The microporous sustained-release membrane is a medical sterile polymer membrane with uniformly distributed nano-sized drug release micropores, which can achieve long-term uniform drug penetration and avoid instantaneous excessive drug stimulation of children's delicate skin.

[0014] As a preferred implementation, the outer periphery of the expansion flap is provided with scale lines, which correspond to the opening and closing expansion range settings of the expansion flap. This allows for direct observation of the foreskin opening expansion size, enabling standardized and precise expansion operations.

[0015] As a preferred embodiment, a rotating block is fixedly connected to the side of the internal threaded rod away from the adjusting electric actuator, and an elastic sealing sleeve is connected to the outer periphery of the insertion rod.

[0016] As a preferred embodiment, the outer periphery of the rotating block is provided with anti-slip texture to facilitate manual rotation and fine adjustment of the internal thread rod.

[0017] As a preferred embodiment, the side of the internally threaded rod is provided with multiple vent holes arranged in a ring array to achieve ventilation and heat dissipation inside the appliance, and to prevent heat accumulation, moisture and bacterial growth during electrical operation.

[0018] Compared with the prior art, the technical effects and advantages of the present invention are as follows:

[0019] I. A multi-level protective structure effectively prevents foreskin stretching injuries in children, significantly enhancing safety.

[0020] Children's foreskin tissue is delicate and their mucous membrane is fragile. Traditional dilators are mostly rigid, integral structures, which can easily cause secondary injuries such as foreskin tearing, mucous membrane redness and swelling, and stinging during dilation due to operational errors, excessive insertion, and local stress concentration, posing significant safety hazards. This application constructs a comprehensive safety protection system through multiple proprietary protective structures, eliminating injury problems at the source. First, the outer sides of the dilation valve and the arc-shaped rod of this device are covered with a removable flexible medical silicone adhesive layer, abandoning the traditional method of direct contact with rigid metal. The high elasticity and softness of silicone material conforms to the physiological curvature of children's foreskin, without sharp edges or hard edges, effectively buffering mechanical stress during dilation and avoiding friction and pressure from rigid structures on the delicate foreskin tissue. Second, the ends of the arc-shaped rod adopt a smooth hemispherical design, and the outer diameter of the ring structure formed when the arc-shaped rod is closed is larger than the inner diameter of the funnel-shaped top of the dilation valve, forming a proprietary end-limiting protective structure that can precisely limit the insertion depth of the instrument, completely solving the problem of traditional instruments having no limit and being prone to excessive insertion and damage to the urethral mucosa. Meanwhile, a high-precision pressure sensing module is embedded between the expansion flap and the silicone layer, which can dynamically monitor the foreskin expansion pressure in real time. Once the pressure exceeds the child's foreskin tolerance threshold, the device can automatically issue a warning and lock the expansion angle, achieving active protection against pressure overload and preventing forced expansion. In addition, the device's inner cavity is equipped with a sealing sleeve and a vent structure, which can not only prevent dust and moisture from entering the device, avoiding cross-infection caused by component corrosion and bacterial growth, but also achieve internal ventilation and heat dissipation, preventing overheating and failure of electrical components, ensuring long-term sterile and safe use of the device, and comprehensively improving the safety of foreskin expansion operations for children.

[0021] II. The adaptive flexible expansion structure is highly adaptable and meets the individual expansion needs of different children.

[0022] Significant individual differences exist in the tightness, contour curvature, and looseness of the foreskin opening in children of different ages and physical conditions. Traditional foreskin dilators are mostly fixed opening and closing structures with a single dilation angle and no adaptive fine-tuning, easily leading to poor fit. This results in either insufficient dilation force and poor dilation effect, or excessive local traction causing local foreskin damage, making them extremely uncommon. This application innovatively adopts a segmented elastic hinged expansion flap structure, dividing the expansion flap into three sections: a root connection section, a middle elastic deformation section, and an end dilation section. The middle elastic deformation section contains a thin elastic steel sheet, which can achieve small-angle autonomous adaptive fine-tuning during dilation. This allows for precise fitting to the natural physiological curvature of the foreskin opening in different children, adapting to various tightness levels of foreskin openings, and completely solving the technical defects of poor adaptability and low fit of traditional devices. Meanwhile, the device features a guide and limiting groove on the spherical surface of its hemispherical shell, which slides and adapts to the guide protrusions on the inner side of the expansion flap. This ensures stable and directional movement of the multiple expansion flaps during opening and closing, without deviation or jamming. Combined with the multiple ring-array distribution of expansion flaps, it achieves uniform, circumferential, and synchronous expansion, avoiding the uneven force on the foreskin caused by traditional single-point or localized expansion. Compared to traditional standardized fixed expansion devices, this device can adapt to the foreskin expansion needs of children of different ages, including toddlers, preschoolers, and school-age children, offering highly individualized adaptability and significantly expanding the clinical applicability of the device.

[0023] III. Precise and controllable intelligent expansion, convenient and efficient operation, and high degree of standardization.

[0024] Traditional manual foreskin dilation relies on the experience of medical staff or parents. The dilation angle, force, and size are entirely based on subjective judgment, resulting in poor dilation accuracy, weak controllability, and unstable operation. Over- or under-dilation is prone to occur, leading to inconsistent rehabilitation outcomes. This application employs a dual precision transmission structure combining electric adjustment and threaded fine-tuning. Utilizing the precise threaded engagement between the internal threaded rod and the handheld tube, combined with the uniform extension and retraction drive of the miniature silent adjustable electric push rod, it can drive the insertion rod and hemispherical shell to achieve multi-stage uniform speed displacement, precisely controlling the opening and closing angle of the dilation flap. This achieves gentle, graded dilation of the foreskin opening, completely eliminating the subjective errors of manual operation. Simultaneously, millimeter-level precision graduations are set on the outer side of the dilation flap, providing a clear and intuitive display of the real-time dilation size. This makes the entire dilation process visible and standardized, allowing operators to accurately control the dilation range and achieve quantified rehabilitation dilation operations. In addition, the inner wall of the hemispherical shell is equipped with multiple sets of independently controllable electromagnets. Each set of electromagnets corresponds to a separate expansion petal and is independently magnetically controlled. The magnetic attraction force of one or more sets of expansion petals can be adjusted according to actual needs to achieve precise attraction, positioning, and repositioning of the expansion petals. This allows for targeted fine-tuning of expansion for cases of localized adhesions or uneven tightness of the foreskin, further improving expansion accuracy and operational flexibility. The matching anti-slip soft rubber pads and grip protrusions adapted to the curvature of fingers are suitable for both dry and wet operating environments, effectively preventing slippage and significantly reducing the difficulty of operation. Even beginners can quickly learn to operate the device, significantly improving its ease of use and practicality.

[0025] IV. Integrating physiotherapy, drug administration, and expansion into one device, it offers diversified functions and improves rehabilitation efficiency.

[0026] Traditional foreskin dilators only have a single mechanical dilation function. In children with phimosis or paraphimosis, dilation often results in redness, swelling, mild inflammation, and poor local blood circulation, requiring additional medication and physical therapy. This process is cumbersome and has a long recovery period. This application integrates multiple functions including physical therapy, uniform drug delivery, and mechanical dilation, achieving integrated dilation, care, and rehabilitation, effectively shortening the recovery period and improving the recovery effect. Firstly, the insertion rod and the outer spherical surface of the hemispherical shell are embedded with evenly distributed low-frequency red light therapy lamps. The embedded waterproof structure design ensures the light is precisely directed towards the dilation area of ​​the foreskin opening. Simultaneously, red light therapy is applied to the local tissue during mechanical dilation, effectively promoting local blood circulation, relieving redness, swelling, and stinging discomfort caused by dilation, and playing a supporting role in reducing inflammation and swelling. This significantly improves the child's comfort during operation and reduces resistance. On the other hand, a ring-shaped drug-releasing groove is set on the outer side of the flexible silicone adhesive layer, which, together with a medical-grade sterile polymer microporous sustained-release membrane, allows for the placement of anti-inflammatory and soothing topical medications during the expansion process. The nanoscale micropores of the membrane enable long-term, uniform drug penetration, avoiding the problems of uneven drug dosage, instantaneous drug irritation, and rapid drug loss associated with traditional manual application. This achieves continuous and gentle drug delivery during expansion, balancing mechanical correction with anti-inflammatory drug care. The multi-functional integrated design eliminates the need for additional auxiliary equipment and manual drug application, simplifying the rehabilitation process. While ensuring gentle and precise expansion and correction, it effectively improves the local physiological state of the foreskin, significantly enhancing the rehabilitation efficiency of foreskin stenosis and phimosis, and possesses extremely high clinical application and home use value.

[0027] This gentle dilator for children's foreskin opening is highly stable after adjustment, combining operational safety, dilation precision, functional integration, and usage stability. It is highly suitable for the non-invasive dilation and care needs of children's delicate genital tissues. Attached Figure Description

[0028] Figure 1 This is a schematic diagram of the structure of the present invention;

[0029] Figure 2 This is the front view of the present invention;

[0030] Figure 3 This is a cross-sectional view of the present invention;

[0031] Figure 4 This is a cross-sectional view of the insertion rod of the present invention;

[0032] Figure 5 This is a schematic diagram of the insertion rod and adjusting electric actuator of the present invention;

[0033] Figure 6 This is a bottom view of the present invention;

[0034] Figure 7 This is a top view of the invention after it has been opened;

[0035] Figure 8 This is a cross-sectional view of the extended valve and microporous release membrane of the present invention;

[0036] Figure 9 This is a cross-sectional view of the extended lobe after deformation according to the present invention.

[0037] Explanation of reference numerals in the attached figures:

[0038] In the picture:

[0039] 1. Handheld tube; 2. Expansion flap; 3. Arc-shaped rod; 4. Insertion rod; 5. Hemispherical shell; 6. Electromagnet; 7. Internally threaded rod; 8. Adjustable electric push rod; 9. Anti-slip soft rubber pad; 10. Grip protrusion; 11. Low-frequency red light therapy lamp; 12. Flexible medical silicone adhesive layer; 13. Pressure sensing module; 14. Drug sustained-release tank; 15. Microporous sustained-release membrane; 16. Rotating block; 17. Sealing sleeve; 18. Vent hole. Detailed Implementation

[0040] In the following description, numerous specific details are set forth in order to provide a more thorough understanding of the invention. However, it will be apparent to those skilled in the art that the invention can be practiced without one or more of these details. In other instances, certain technical features well-known in the art have not been described in order to avoid obscuring the invention.

[0041] The connection method can be any existing method, such as bonding, welding, or bolting, depending on the actual needs.

[0042] Please see Figures 1 to 9 A gentle foreskin dilator adapted for children, comprising:

[0043] The handheld tube 1 has multiple expansion flaps 2 rotatably connected to its top for gently widening the foreskin opening of children. Each expansion flap 2 employs a segmented, elastically hinged structure, consisting of a root connecting section, a middle elastic deformation section, and an end expansion section. The middle elastic deformation section contains a thin, elastic steel sheet capable of small-angle adaptive fine-tuning to accommodate different tightness and curvature of the foreskin opening in children. An arc-shaped rod 3 is connected to the outer wall of the expansion flap 2. The ends of the arc-shaped rod 3 are hemispherical, and its curvature matches the natural physiological curvature of the foreskin opening in children. When the multiple expansion petals 2 are fully retracted, they are spliced ​​together to form a tapered, closed funnel-shaped structure without sharp gaps. When the multiple arc-shaped rods 3 are retracted simultaneously, they surround and form a regular and smooth circular limiting structure, which facilitates the insertion of the instrument into the foreskin opening without damage. The outer diameter of the circular structure formed when the arc-shaped rods 3 are retracted is larger than the inner diameter of the top of the funnel-shaped structure formed when the expansion petals 2 are retracted, forming an end limiting and protective structure, which can effectively prevent the expansion petals 2 from extending too far, accurately limit the insertion depth, and prevent mucosal damage caused by excessively deep operation.

[0044] The curved rod 3 is completely covered with a thickened flexible medical silicone adhesive layer 12, which retains the hemispherical rounded structure while achieving flexible contact throughout the process. The fixed connection between the curved rod 3 and the expansion flap 2 is changed to a micro elastic hinge structure, which can slightly and adaptively adjust the curvature to fit the physiological shape of the foreskin opening of different children, evenly distribute the expansion pressure, and avoid local pressure damage.

[0045] Corresponding angle limiting protrusions are added to the inner side of the top of the handheld tube 1 and the base of the rotating expansion petal 2. At the same time, a limiting slot is preset on the body of the insertion rod 4 to limit the maximum pushing stroke of the hemispherical shell 5 and the maximum outward turning angle of the expansion petal 2. Combined with the double protection of the pressure sensing module 13, when the safe expansion threshold is reached, the controller automatically locks the electric push rod 8 to stop pushing. This eliminates the problem of over-expansion from both mechanical structure and electronic control levels, and is suitable for the safe expansion standards of children of different ages.

[0046] Insertion rod 4 is set in the inner cavity of handheld tube 1. The top of insertion rod 4 is connected to a hemispherical shell 5 for pushing expansion petals 2 to rotate outward. The outer spherical surface of hemispherical shell 5 is completely fitted and matched with the inner sidewall of multiple sets of expansion petals 2. Expansion petals 2 are made of iron material. Electromagnets 6 for attracting and fixing expansion petals 2 are installed on the inner wall of hemispherical shell 5.

[0047] An internal thread rod 7 is set in the inner cavity of the handheld tube 1. The inner wall of the handheld tube 1 has an internal thread that is threaded to the internal thread rod 7. An adjusting electric push rod 8 is detachably connected to the side of the internal thread rod 7 near the expansion flap 2. The moving part of the adjusting electric push rod 8 is connected and fixed to the insertion rod 4.

[0048] An ultra-thin medical insulating and heat-insulating silicone layer is added between the electromagnet 6 and the expansion flap 2 to isolate the current and working heat and avoid tissue irritation; the magnetic attraction control program is optimized so that the electromagnet 6 automatically increases its short-term attraction force after expansion is in place, and the magnetic attraction force is dynamically fine-tuned according to the tissue tension fed back by the pressure sensing module 13 to adapt to different foreskin tightness.

[0049] The adjusting electric actuator 8 is replaced with a high-precision stepping micro electric actuator, which, together with a controller, achieves stepless micron-level fine adjustment. Relying on the original controller of the device to output a unified signal, the extension and retraction stroke and advancement speed of the electric actuator 8 are precisely controlled, driving the insertion rod 4 and hemispherical shell 5 forward at a uniform speed. This eliminates the error of manual adjustment and achieves standardized, precise, and gentle expansion, which is suitable for the expansion needs of young children with narrow foreskin openings.

[0050] In its initial state, the multiple expansion petals 2 naturally converge and form a funnel-shaped structure that facilitates insertion into the child's foreskin opening. Simultaneously, the arc-shaped rod 3 connected to the outer side of the expansion petals 2 converges, forming a regular circular structure. Because the ends of the arc-shaped rod 3 are hemispherical, and the outer diameter of the converged circular ring of the arc-shaped rod 3 is larger than the inner diameter of the funnel-shaped top of the expansion petal 2, the head of the device has no sharp edges and the transition is smooth, effectively avoiding scratching the foreskin mucosa during insertion. At the same time, the electromagnet 6 on the inner wall of the hemispherical shell 5 can be energized in advance to slightly attract the iron expansion petals 2, ensuring a tight and stable converged state.

[0051] Slowly and smoothly insert the folded-up device head into the child's foreskin opening, so that the flexible medical silicone adhesive layer 12 with its curved surface completely adheres to the inner wall of the foreskin, completing the device placement. At this time, the insertion rod 4 and the hemispherical shell 5 are in the preset initial position inside the handheld tube 1.

[0052] The operator controls the extension of the electric actuator 8, and the moving part of the electric actuator 8 pushes the insertion rod 4 and the hemispherical shell 5 at the top forward. During the forward movement of the hemispherical shell 5, it gradually pushes multiple iron expansion flaps 2, causing the expansion flaps 2 to slowly rotate outward with the connection position at the top of the handheld tube 1 as the fulcrum, thus achieving a gentle expansion of the foreskin opening. The operator can visually observe the expansion size through the scale lines on the outer circumference of the expansion flaps 2, and, combined with the fitting pressure feedback from the pressure sensing module 13, precisely control the expansion amplitude to avoid over-expansion.

[0053] Once the foreskin opening has expanded to the appropriate size, the electric push rod 8 is stopped from advancing, and the electromagnet 6 on the inner wall of the hemispherical shell 5 is energized. The electromagnet 6 is used to firmly attract and fix the iron expansion petal 2 using magnetic attraction, locking the expansion angle of the expansion petal 2 to prevent rebound or deviation during the expansion process, and ensuring a stable expansion state.

[0054] After the foreskin dilation and correction and physiotherapy medication are completed, first turn off the power to the electromagnet 6 to release the magnetic lock on the dilation valve 2, then control the adjustment electric push rod 8 to retract, driving the insertion rod 4 and hemispherical shell 5 to reset. The multiple dilation valves 2 and the arc rod 3 automatically close and reset, restoring the initial funnel-shaped and annular closing structure. Finally, the device is smoothly moved out of the foreskin opening to complete a single complete dilation nursing operation.

[0055] The outer periphery of the handheld tube 1 is detachably connected to an anti-slip soft rubber pad 9 for easy hand gripping. The outer periphery of the anti-slip soft rubber pad 9 is integrally injection molded with multiple gripping protrusions 10 adapted to the gripping posture of the fingers.

[0056] The operator holds the anti-slip soft rubber pad 9 on the outer periphery of the holding tube 1 and relies on the grip protrusions 10 adapted to the finger posture to achieve a stable grip and prevent slippage during operation.

[0057] Multiple low-frequency red light therapy lamps 11 for physiotherapy are embedded in the outer periphery of the insertion rod 4 and the hemispherical shell 5. The light irradiation angle is directed towards the foreskin opening expansion and contact area, which can simultaneously achieve local anti-inflammatory, soothe redness and swelling, and reduce the discomfort of expansion during the expansion process.

[0058] Miniature low-frequency red light therapy lamps 11 are evenly added to the inner wall of each expansion flap 2, forming a full-area irradiation structure with the existing insertion rod 4 and hemispherical shell 5 therapy lamps. They unfold synchronously with the outward expansion of the expansion flap 2, covering the foreskin opening and the entire inner wall tissue of the foreskin in all directions, completely eliminating the blind spots of therapy, maximizing the effect of red light therapy in reducing swelling, promoting circulation and repairing tissue, and improving the overall rehabilitation and nursing effect.

[0059] The low-frequency red light therapy lamp 11 embedded in the outer periphery of the insertion rod 4 and the hemispherical shell 5 is activated to provide red light therapy to the local tissue of the foreskin, promoting blood circulation and relieving traction edema. During operation, the ventilation holes 18 in the annular array on the side of the internal thread rod 7 ensure ventilation of the inner cavity of the handheld tube 1, and the elastic sealing sleeve 17 prevents body fluids and medicines from seeping into the inner cavity, protecting the internal electrical control and transmission structure.

[0060] Both the expansion flap 2 and the arc-shaped rod 3 are detachably connected to a flexible medical silicone adhesive layer 12, and the outer wall structure of the flexible medical silicone adhesive layer 12 is an arc-shaped curved surface that fits the foreskin.

[0061] Multiple pressure sensing modules 13 are installed between the expansion valve 2 and the flexible medical silicone adhesive layer 12. A drug release groove 14 for temporarily placing drugs is opened on the outer periphery of the flexible medical silicone adhesive layer 12. A microporous sustained-release membrane 15 for sealing the drug amount and releasing it at a uniform speed is detachably snapped onto the outside of the drug release groove 14. The microporous sustained-release membrane 15 is a medical sterile polymer membrane with uniformly distributed nano-sized drug release micropores, which can realize long-term uniform drug penetration and avoid instantaneous excessive drug stimulation of children's delicate skin.

[0062] The fixed drug release tank 14 has been optimized into a detachable modular tank. The inner wall of the tank features multi-level micropores, and it is equipped with replaceable microporous sustained-release membranes 15 in three sizes: coarse, medium, and fine, suitable for liquid, gel, and paste drugs, respectively. The microporous sustained-release membrane 15 has been modified into a snap-fit, fully enclosed structure with added sealing rings at the edges, completely eliminating problems such as membrane loosening, detachment, and drug leakage, ensuring uniform and stable drug release. It can also be individually disassembled for cleaning and replacement, improving the equipment's reusability.

[0063] According to nursing needs, nursing medication can be filled into the drug release tank 14 of the silicone adhesive layer, and a microporous sustained-release membrane 15 can be installed to achieve drug sealing and sustained release.

[0064] The drug solution in the drug release tank 14 is released at a uniform rate through the microporous release membrane 15, and the drug administration and care are completed simultaneously during the expansion process.

[0065] The outer periphery of the expansion flap 2 is provided with scale lines, which correspond to the opening and closing expansion range settings of the expansion flap 2. The expansion size of the foreskin opening can be observed intuitively, realizing standardized and precise expansion operation.

[0066] A rotating block 16 is fixedly connected to the side of the internal thread rod 7 away from the adjusting electric push rod 8. An elastic sealing sleeve 17 is connected to the outer periphery of the insertion rod 4. The outer periphery of the rotating block 16 is provided with anti-slip texture, which facilitates manual rotation and fine adjustment of the internal thread rod 7. Multiple vent holes 18 arranged in a ring array are provided on the side of the internal thread rod 7 to achieve ventilation and heat dissipation in the inner cavity of the appliance, and to avoid heat accumulation, moisture and bacterial growth during electrical operation.

[0067] A waterproof and breathable membrane is attached to the outside of the vent hole 18 of the internal threaded rod 7 to achieve ventilation and heat dissipation while preventing moisture, medicine, and dust from seeping into the inner cavity. The single-layer elastic sealing sleeve 17 is upgraded to a double-layer stepped sealing structure, using aging-resistant medical silicone material to improve the telescopic sealing performance and service life. The dual protection structure effectively protects the electrical control and transmission components inside the handheld tube 1, preventing malfunctions due to moisture.

[0068] During operation, the vent holes 18 in the annular array on the side of the internal thread rod 7 ensure ventilation in the inner cavity of the handheld tube 1, while the elastic sealing sleeve 17 prevents bodily fluids and medicines from seeping into the inner cavity, protecting the internal electrical control and transmission structure.

[0069] It should be emphasized that this application is in a specific environment, therefore all structures and instruments are protected and regularly maintained and replaced to ensure safe and smooth use.

[0070] Based on the existing controller, an upgraded intelligent speed regulation program is implemented, combined with real-time pressure data from the pressure sensing module 13, to achieve pressure-adaptive speed regulation: when the pressure approaches the safety threshold, the speed is automatically reduced and the expansion is slowed down at a low speed; when the pressure is stable, the propulsion is maintained at a uniform speed. A micro-elastic overload buffer structure is added to the telescopic end of the electric push rod 8, which releases pressure through mechanical buffer when the electric control lock fails, thus doubly avoiding the risk of overload expansion. Multiple age-adaptive programs for children are preset, allowing for one-click matching of the propulsion speed and expansion threshold for the corresponding age group, improving the efficiency of standardized operation.

[0071] The controller is equipped with a self-test upon startup and a real-time synchronization verification program. After the equipment starts up, it automatically detects the extension accuracy of the electric push rod 8, the adsorption performance of the electromagnet 6, and the illumination status of the physiotherapy lamp 11, and automatically corrects the synchronization timing. An abnormal alarm function is added. When there is an electrical control deviation or component failure, an audible and visual warning is issued to prompt maintenance and replacement, ensuring the long-term stable operation of the equipment.

[0072] The upgraded physiotherapy lamp 11 control module is linked to the pressure sensing module 13 and the expansion scale data to achieve intelligent zone control: the greater the foreskin expansion and the higher the tissue pressure, the more the red light physiotherapy power is automatically increased to enhance the swelling reduction and circulation promotion effect; three physiotherapy modes (mild, regular, and severe edema) are set, which can be manually switched; independent zone control is achieved, with low power standby when the device is retracted and full power full-area irradiation after full expansion, accurately adapting to rehabilitation needs.

[0073] A layered flow-guiding microporous structure is added inside the drug release tank 14, which, together with the outer microporous release membrane 15, forms a double-layer release system to ensure the uniform release of liquid, gel, and ointment drugs throughout the process; the sealing ring is upgraded to an embedded, thickened, aging-resistant medical silicone ring to improve sealing durability; a micro pressure-sensing residual detection module is added inside the drug tank, which will issue an early warning through the controller when the drug level is insufficient or the release is blocked, and promptly remind the user to replenish the drug or replace the membrane.

[0074] By linking drug release and physiotherapy procedures through the controller, a time-series coordinated mode is set: low-frequency physiotherapy preheating for 3 minutes before drug administration to expand tissue pores and improve drug permeability; constant physiotherapy intensity during the middle of drug administration to assist drug absorption; and enhanced physiotherapy in the later stage of drug administration to accelerate blood circulation and repair damaged mucous membranes, thus achieving integrated physiotherapy and drug administration care.

[0075] The external adhesive waterproof and breathable membrane has been replaced with an embedded slot-type fixing structure, which is resistant to high temperature and disinfection and eliminates the problem of falling off and curling. A micro liquid guiding groove has been added to the inside of the double-layer elastic sealing sleeve 17 to drain a small amount of seeping water vapor and residual liquid. A detachable microporous dustproof and anti-clogging mesh has been added to the outside of the vent 18. Regular disassembly and cleaning can be performed to avoid clogging and continuously ensure the ventilation, heat dissipation, waterproof and dustproof effects of the inner cavity.

[0076] Electromagnet 6, adjusting electric push rod 8, low-frequency red light therapy lamp 11, and pressure sensing module 13 are all conventional instruments. Their working principles, dimensions, and models are irrelevant to the function of this application, so they will not be described in detail. The control method of this invention is through a controller. The control circuit of the controller can be implemented by those skilled in the art through simple programming. In order to facilitate the inspection, maintenance, and parts replacement of the device, the parts inside a single device are usually from the same manufacturer and of the same model, function, and batch. Therefore, even if there is a certain difference between two or more electrical control devices, the synchronous movement of the electrical control devices can still be maintained under the action of the controller. The power supply is also common knowledge in the field. Furthermore, this invention is mainly used to protect mechanical devices, so the control method and circuit connection will not be explained in detail in this invention.

[0077] For equipment that requires synchronized movement, methods such as using the same controller to output signals, parallel driving, and synchronous stroke control can be adopted to enable multiple groups of equipment to move synchronously.

[0078] All standard parts used in this invention can be purchased from the market, and irregular parts can be customized according to the description and drawings. The specific connection methods of each part adopt conventional methods such as bolts, rivets, and welding that are mature in the prior art. The machinery, parts and equipment all adopt conventional models in the prior art.

[0079] Standardize the specifications of all detachable parts to achieve universal interchangeability; add alignment protrusions and slots to the inside of the silicone bonding layer 12, the slow-release membrane 15, and the anti-slip soft rubber pad 9 for one-click precise alignment and installation, eliminating misalignment, leakage, and slippage problems; and provide a standardized accessory and consumable package to reduce equipment maintenance and replacement costs.

[0080] The one-piece anti-slip soft rubber pad 9 has been replaced with a detachable modular grip pad, equipped with three sizes of replaceable grip protrusions 10 to fit different hand shapes; the surface of the grip protrusions 10 is added with micron-level anti-slip texture to improve grip stability in dry and wet conditions and prevent slippage during operation.

[0081] A small handheld digital display terminal is added to the system, which displays core data such as expansion angle, expansion diameter, fitting pressure, physiotherapy power, and drug administration status in real time. It provides real-time audible and visual warnings when thresholds are exceeded. It is equipped with preset standard parameters for children's age groups and automatically matches the optimal expansion parameters, eliminating the need for repeated manual judgment and improving the accuracy and standardization of operation.

[0082] The controller system is equipped with component life monitoring and wear statistics functions. It automatically assesses the wear status of components based on usage frequency and working duration, and accurately pushes maintenance and replacement reminders. The equipment structure is optimized to reduce hygiene dead spots. All exposed detachable structures can be completely disassembled and disinfected independently. A standardized hierarchical maintenance process is established to match the differentiated maintenance cycles of mechanical structures, electrical control components, and silicone consumables, ensuring the long-term safe and stable operation of the equipment.

[0083] Working principle

[0084] Step 1: Equipment Pre-treatment and Assembly Preparation. The operator first completes the preliminary preparation work for the equipment, attaching the flexible medical silicone adhesive layer 12 to the outer periphery of the expansion valve 2 and the arc-shaped rod 3. Depending on the nursing needs, the medication can be filled into the drug release tank 14 of the silicone adhesive layer, and a microporous sustained-release membrane 15 is installed to achieve drug sealing and sustained release. Simultaneously, the operator checks the secure assembly of the anti-slip soft rubber pad 9 and the grip protrusion 10 on the outer periphery of the handheld tube 1, confirming that the elastic sealing sleeve 17 on the outer periphery of the insertion rod 4 is intact, ensuring the overall assembly of the equipment is neat and without looseness, laying the foundation for subsequent operations.

[0085] Step 2: Closing and Returning to Position, Completing Preoperative Shaping. In the initial state, the multiple expansion flaps 2 naturally close and converge, forming a funnel-shaped structure that is easy to insert into the child's foreskin opening. At the same time, the arc-shaped rod 3 connected to the outside of the expansion flap 2 closes simultaneously, forming a regular circular structure. Because the two ends of the arc-shaped rod 3 are set as hemispherical surfaces, and the outer diameter of the closed circular ring of the arc-shaped rod 3 is larger than the inner diameter of the funnel-shaped top of the expansion flap 2, the head of the device has no sharp edges and the transition is smooth, effectively avoiding scratching the foreskin mucosa during insertion. At the same time, the electromagnet 6 on the inner wall of the hemispherical shell 5 can be energized in advance to slightly attract the iron expansion flap 2, ensuring a tight and stable closed state.

[0086] Step 3: Precisely insert the device and fit it to the affected area of ​​the foreskin. The operator holds the non-slip soft rubber pad 9 on the outer periphery of the holding tube 1, and uses the grip protrusions 10 adapted to the finger posture to achieve a stable grip and prevent slippage. Slowly and smoothly insert the folded and shaped device head into the child's foreskin opening, so that the flexible medical silicone adhesive layer 12 with its curved surface completely fits the inner wall tissue of the foreskin, completing the device positioning. At this time, the insertion rod 4 and the hemispherical shell 5 are in the preset initial position inside the cavity of the holding tube 1.

[0087] Step 4: Mechanical linkage control to achieve gradual and gentle expansion. The operator controls the extension of the electric actuator 8, and then the moving part of the electric actuator 8 pushes the insertion rod 4 and the hemispherical shell 5 at the top forward. During the forward movement of the hemispherical shell 5, it gradually pushes multiple iron expansion petals 2, causing the expansion petals 2 to slowly rotate outward with the connection position at the top of the handheld tube 1 as the fulcrum, achieving gentle expansion of the foreskin opening. The operator can visually observe the expansion size through the scale lines on the outer circumference of the expansion petals 2, and combine the fitting pressure feedback from the pressure sensing module 13 to precisely control the expansion amplitude and avoid over-expansion.

[0088] Step 5: Electromagnetic locking and fixation, combined with assisted rehabilitation. Once the foreskin opening has expanded to the appropriate size, stop adjusting the electric push rod 8. Control the electromagnet 6 on the inner wall of the hemispherical shell 5 to operate, using magnetic attraction to firmly hold and fix the iron expansion flap 2, locking the expansion angle of the expansion flap 2 to prevent rebound or displacement during expansion, ensuring stable expansion. Simultaneously, the low-frequency red light therapy lamp 11 embedded in the outer periphery of the insertion rod 4 and the hemispherical shell 5 is activated, providing red light therapy to the local foreskin tissue to promote blood circulation and relieve traction edema; the medication in the drug release tank 14 is released evenly and slowly through the microporous release membrane 15, simultaneously completing medication administration during expansion. During the operation, the vent holes 18 in the annular array on the side of the internal thread rod 7 ensure ventilation inside the handheld tube 1, while the elastic sealing sleeve 17 prevents bodily fluids and medication from seeping into the inner cavity, protecting the internal electrical control and transmission structures.

[0089] Step 6: Power off and reset, then gently remove the device. After the foreskin dilation and correction and physiotherapy medication administration are completed, first turn off the power to the electromagnet 6 to release the magnetic lock on the dilation valve 2. Then, control the retraction of the electric push rod 8 to drive the insertion rod 4 and hemispherical shell 5 to reset. The multiple dilation valves 2 and the arc-shaped rod 3 will automatically retract and reset, restoring the initial funnel-shaped and annular retraction structure. Finally, gently remove the device from the foreskin opening to complete a single complete dilation nursing operation.

[0090] It should be noted that in this article, relational terms such as one and two are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations.

[0091] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A gentle dilator for the foreskin opening of children, characterized in that: include: The handheld tube (1) has multiple expansion flaps (2) at its top for gently expanding the foreskin opening of children. The expansion flaps (2) adopt a segmented elastic hinge structure, which is divided into a root connection section, a middle elastic deformation section, and an end expansion section. The middle elastic deformation section has a built-in thin elastic steel sheet that can achieve small-angle adaptive fine adjustment to adapt to different tightness and contour curvature of the foreskin opening of children. The outer wall of the expansion flap (2) is connected to an arc-shaped rod (3). The two ends of the arc-shaped rod (3) are constructed as hemispherical surfaces, and the curvature of the arc-shaped rod (3) is consistent with the natural physiological curvature of the foreskin opening of children. When the multiple expansion petals (2) are fully closed, they are spliced ​​together to form a closed funnel-shaped structure with a tapered gradient and no sharp gaps. When the multiple arc rods (3) are closed synchronously, they surround and form a regular and smooth circular limiting structure, which makes it easy for the instrument to be inserted into the foreskin opening without damage. The outer diameter of the circular structure formed when the arc rods (3) are closed is larger than the inner diameter of the top of the funnel-shaped structure formed when the expansion petals (2) are closed, forming an end limiting protection structure, which can effectively prevent the expansion petals (2) from extending too far, accurately limit the insertion depth, and prevent mucosal damage caused by excessive operation. An insertion rod (4) is set in the inner cavity of the handheld tube (1). The top end of the insertion rod (4) is connected to a hemispherical shell (5) for pushing the expansion petal (2) to rotate outward. The outer spherical surface of the hemispherical shell (5) is completely fitted and matched with the inner sidewall of the multiple sets of expansion petals (2). The expansion petal (2) is made of iron material. An electromagnet (6) for attracting and fixing the expansion petal (2) is installed on the inner wall of the hemispherical shell (5). An internal thread rod (7) is provided in the inner cavity of the handheld tube (1). The inner wall of the handheld tube (1) is provided with an internal thread that is threaded to the internal thread rod (7). An adjusting electric push rod (8) is detachably connected to the side of the internal thread rod (7) near the expansion flap (2). The moving part of the adjusting electric push rod (8) is connected and fixed to the insertion rod (4).

2. The gentle foreskin dilator adapted for children according to claim 1, characterized in that: The outer periphery of the handheld tube (1) is detachably connected to an anti-slip soft rubber pad (9) that is easy for the hand to grip. The outer periphery of the anti-slip soft rubber pad (9) is integrally injection molded with multiple gripping protrusions (10) that are adapted to the gripping posture of the fingers.

3. The gentle foreskin dilator adapted for children according to claim 1, characterized in that: Multiple low-frequency red light therapy lamps (11) for physiotherapy are embedded in the outer periphery of the insertion rod (4) and the hemispherical shell (5). The light irradiation angle is directed towards the foreskin opening expansion and fitting area, which can simultaneously achieve local anti-inflammatory, soothe redness and swelling, and reduce the discomfort of expansion during the expansion process.

4. The gentle foreskin dilator adapted for children according to claim 1, characterized in that: The outer periphery of both the expansion flap (2) and the arc rod (3) can be detachably connected to a flexible medical silicone adhesive layer (12), and the outer wall structure of the flexible medical silicone adhesive layer (12) is an arc-shaped curved surface that fits the foreskin.

5. A gentle foreskin dilator adapted for children according to claim 4, characterized in that: Multiple pressure sensing modules (13) are installed between the expansion valve (2) and the flexible medical silicone adhesive layer (12), and a drug release groove (14) for temporarily placing drugs is provided on the outer periphery of the flexible medical silicone adhesive layer (12).

6. The gentle foreskin dilator adapted for children according to claim 5, characterized in that: The outer side of the drug release tank (14) is detachably snapped with a microporous sustained-release membrane (15) for sealing the amount of drug and releasing it at a uniform speed. The microporous sustained-release membrane (15) is a medical sterile polymer membrane with nano-sized drug release micropores evenly distributed on the membrane body, which can realize long-term uniform drug penetration and avoid instantaneous excessive drug stimulation of children's delicate skin.

7. A gentle foreskin dilator adapted for children according to claim 5, characterized in that: The outer periphery of the expansion petal (2) is provided with scale lines, which correspond to the opening and closing expansion range of the expansion petal (2). The expansion size of the foreskin opening can be observed intuitively, and standardized and precise expansion operation can be achieved.

8. The gentle foreskin dilator adapted for children according to claim 1, characterized in that: The internal thread rod (7) is fixedly connected to a rotating block (16) on the side away from the adjusting electric push rod (8), and the outer periphery of the insertion rod (4) is connected to a resilient sealing sleeve (17).

9. A gentle foreskin dilator adapted for children according to claim 8, characterized in that: The outer periphery of the rotating block (16) is provided with anti-slip texture, which facilitates manual rotation and fine adjustment of the internal thread rod (7). The side of the internal thread rod (7) is provided with multiple vent holes (18) arranged in a ring array.

10. A gentle foreskin dilator adapted for children according to claim 8, characterized in that: The internal thread rod (7) has multiple vent holes (18) arranged in a ring array on the side of the rod body to achieve ventilation and heat dissipation in the inner cavity of the appliance, and to avoid heat accumulation, moisture and bacterial growth during electrical work.

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