Male urethral pathogen sampling assembly capable of reducing irritation

Abstract

The male urethral pathogen sampling assembly comprises a sampler and a positioner, the two ends of the sampler are the near end and the far end, the sampler is composed of a straight rod and a flexible membrane bag, the periphery of the straight rod is sleeved with the flexible membrane bag, the near end of the flexible membrane bag is fixed, and the far end of the straight rod is provided with a guide-in head; the positioner is provided with a buckling groove for containing the glans penis and a through opening corresponding to the urethral orifice, and can be arranged outside the glans penis in a sleeving mode so that the far end of the sampler can penetrate through and be placed into the urethra. The far end of the flexible membrane bag is of an outward turning structure, an inner side membrane sleeving part and an outer side membrane turning part are formed, and the membrane turning part is connected with the positioner. During sampling, the membrane turning part is gently attached to the inner wall of the urethra, and when the straight rod is pushed, the flexible membrane bag is only stably turned and rolled towards the near end relative to the straight rod. The flexible membrane bag is used as a contact carrier and matched with precise positioning and fulcrum effects of the positioner, mechanical injury of mucous membranes is eradicated, meanwhile, direct contact between medical staff and the glans penis is isolated, pain of a patient is relieved, the matching degree is improved, and sampling failure is avoided.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a male urethral pathogen sampling component that can reduce irritation. Background Technology

[0002] Sampling of pathogens (such as bacteria, mycoplasma, chlamydia, etc.) in the male urethra is an important step in diagnosing urinary tract infections such as urethritis and prostatitis.

[0003] The most commonly used sampling method in clinical practice is the urethral swab sampling method, in which the operator inserts a thin cotton swab or flocked swab directly into the patient's urethra, and then rotates and rubs it after reaching the predetermined sampling position to obtain a secretion sample.

[0004] The shortcomings of the above-mentioned technologies are as follows: Traditional swabs are made of a high-hardness material, which can easily cause mechanical irritation to the urethral mucosa during insertion and rotation, resulting in severe pain, burning sensation and obvious foreign body sensation for patients. This not only causes great suffering to patients, but also reduces patient cooperation and sampling experience.

[0005] Traditional swabs rely on rotational friction to obtain samples. The amount of sample obtained is easily limited by the force of operation, the rotation angle, and the swab's adsorption capacity. Improper operation may result in insufficient sample volume or excessively low pathogen concentration in the sample. At the same time, the rotational friction process may damage some pathogen structures, affecting the accuracy of subsequent test results and increasing the risk of misdiagnosis.

[0006] Therefore, designing a male urethral pathogen sampling component that can reduce irritation to the urethral wall during sampling, while improving the patient's sampling experience and increasing clinical sampling compliance has become an urgent problem to be solved in the field of medical device technology. Summary of the Invention

[0007] The purpose of this invention is to provide a male urethral pathogen sampling component that reduces irritation, aiming to solve the problems of mechanical irritation of the urethral mucosa, significant patient pain, and low compliance caused by the rigid rod of traditional urethral swab sampling methods.

[0008] To achieve the above-mentioned objectives, the present invention adopts the following technical solution: A male urethral pathogen sampling assembly with reduced irritation includes a sampler and a locator. The sampler has a proximal and a distal end, and includes a straight rod and a flexible membrane sac. The distal end of the straight rod has an inlet for acquiring urethral pathogens. The flexible membrane sac is fitted around the outer periphery of the straight rod, with its proximal end fixed to the outer surface of the straight rod. The locator has a groove for accommodating the glans penis, and an opening corresponding to the urethral orifice. The locator can be fitted over the glans penis, and the distal end of the sampler can pass through the opening and be inserted into the urethra. The distal end of the flexible membrane sac features an everted structure design, forming an inner sheath portion and an outer everted portion, which connects to the locator. When the straight rod, carrying the flexible membrane sac, is inserted into the urethra, the everted portion contacts the inner wall of the urethra. As the straight rod continues to advance deeper into the urethra, the flexible membrane sac flips proximally relative to the straight rod.

[0009] Preferably, the sampler further includes an inflatable balloon, a flexible membrane balloon with a membrane cavity, and an airway inside a straight rod. One end of the airway is located on the outer circumference of the straight rod and connects to the membrane cavity, while the other end connects to the inflatable balloon. When the inflatable balloon is squeezed, the gas inside the balloon flows into the membrane cavity through the airway, driving the flexible membrane balloon to expand and press against the inner wall of the urethra. When the inflatable balloon is released, it returns to its original shape due to its elasticity, and the gas inside the membrane cavity flows back to the inflatable balloon through the airway, driving the flexible membrane balloon to retract and release the pressure on the inner wall of the urethra. By repeatedly squeezing and releasing the inflatable balloon, the flexible membrane balloon can generate a periodic squeezing and tapping motion against the inner wall of the urethra.

[0010] Preferably, the locator is made of medical-grade silicone material. Symmetrical grip grooves are provided on both sides of the locator for easy holding. The surface of the grip groove is curved and has anti-slip texture to increase friction.

[0011] Preferably, the positioner and the film-turning part are detachably connected.

[0012] Preferably, the end face of the locator facing away from the buckle groove is provided with an annular groove, and the flipping part is provided with a retaining ring that matches the shape of the groove, and the retaining ring is embedded in the groove.

[0013] Preferably, the gap between the inner circumferential surface of the distal end of the film-covering part and the outer circumferential surface of the straight rod, and the gap between the film-covering part and the film-turning part are both no greater than 0.5 mm.

[0014] Preferably, the inlet head is a rounded cone shape.

[0015] Preferably, the outer surface of the infusion head is coated with Teflon.

[0016] Compared with existing technologies, the male urethral pathogen sampling component that adopts the above-mentioned technical solution and reduces irritation has the following beneficial effects: This invention abandons the traditional design of a rigid swab shaft directly contacting the urethral wall. Instead, it uses a flexible membrane sac as the contact carrier with the urethral wall during sampling, eliminating mechanical damage to the mucosa caused by rigid friction. The distal end of the flexible membrane sac features an everted structure, and the everted portion is connected to a locator. The locator is stably fitted onto the glans penis via a groove, achieving precise alignment between the urethral opening and the inlet, and providing a reliable fixing point for the everted portion. When the straight shaft is advanced deeper into the urethra, the flexible membrane sac only smoothly rolls up proximally relative to the shaft, maintaining a gentle fit with the urethral wall without any additional rotation or impact. This completely eliminates the severe pain, burning sensation, and foreign body sensation caused by the rotation and friction of traditional swabs. Furthermore, the locator effectively isolates the glans penis from direct contact between medical staff's fingers and the glans, preventing discomfort caused by excessive pressure on the glans penis, significantly reducing patient sampling pain, improving patient cooperation, and fundamentally preventing sampling failure due to patient resistance.

[0017] By repeatedly squeezing and releasing the inflatable sac, the flexible membrane sac creates a periodic squeezing and tapping motion against the urethral wall. The inflated sac makes full contact with the urethral wall, and the tapping motion allows urethral secretions to flow and distribute more evenly across the sac, increasing the sample carrying capacity. Simultaneously, this gentle squeezing and tapping method does not damage the structural integrity of pathogens, preserving their original morphology and activity to the greatest extent possible. This provides a more reliable sample basis for subsequent testing, effectively improving the accuracy of test results and reducing the risk of misdiagnosis due to sample quality issues.

[0018] During operation, medical staff can hold the penis and locator stably with one hand, while using the other hand to smoothly insert the distal end of the sampler through the inlet into the urethra until the guide head reaches the lesion. Sample collection is then completed by repeatedly squeezing and releasing the inflatable balloon. This invention abandons the traditional method of obtaining samples through rotational friction with swabs. Through the synergistic effect of the inflatable balloon and the flexible membrane sac, it achieves periodic squeezing and tapping of the urethral wall, making the sampling operation easier to master and requiring less advanced operational skills from medical staff.

[0019] After sampling, medical staff can hold the penis and locator with one hand for stable fixation, while using the other hand to grasp the proximal end of the sampler and pull it back. During this process, the flapping membrane simultaneously flips back and re-wraps the straight rod, allowing the sample adhering to the surface of the flapping membrane to be hidden and stored between the flexible membrane and the straight rod. This operation method effectively protects the collected sample, isolating it from bacteria in the air and preventing airborne contamination, while also avoiding contact contamination caused by direct hand contact with the sample after sampling, ensuring the purity of the sample and the validity of the test. Attached Figure Description

[0020] Figure 1This is a schematic diagram of one side of the component in Example 1.

[0021] Figure 2 This is a schematic diagram of the structure on the other side of this component in Embodiment 1.

[0022] Figure 3 This is a schematic diagram of the locator in Example 1.

[0023] Figure 4 This is a cross-sectional view of the component in Embodiment 1. Figure 5 This is a schematic diagram of the use of this component in Example 1.

[0024] Figure 6 for Figure 5 Enlarged view of point A in the middle.

[0025] Figure 7 This is a schematic diagram of the import head structure in Example 2.

[0026] Reference numerals: 1. Sampler; 10. Balloon; 11. Straight rod; 12. Airway; 13. Inlet head; 2. Flexible membrane capsule; 20. Membrane capsule cavity; 21. Sheathing part; 22. Flipping part; 23. Clamping ring; 3. Positioner; 30. Clip groove; 31. Opening; 32. Grip groove; 33. Clamping groove; 4. Glans penis; 40. Urethral region; 5. Anti-adhesion groove. Detailed Implementation

[0027] To further illustrate the technical means and effects of the present invention in achieving its intended purpose, the following detailed description of the specific implementation methods, structures, features, and effects of the present invention, in conjunction with the accompanying drawings and preferred embodiments, is provided below.

[0028] Example 1 like Figures 1 to 6 The illustrated male urethral pathogen sampling assembly, designed to reduce irritation, includes a sampler 1 and a locator 3. The sampler 1 has a proximal end and a distal end, and includes a straight rod 11 and a flexible membrane sac 2. The distal end of the straight rod 11 has an inlet head 13 for collecting pathogens from the urethra 40. The flexible membrane sac 2 is fitted around the outer periphery of the straight rod 11, with its proximal end fixed to the outer peripheral surface of the straight rod 11. The locator 3 has a groove 30 for accommodating the glans penis 4, and an opening 31 corresponding to the urethral opening 40. The locator 3 can be fitted over the glans penis 4, and the distal end of the sampler 1 can pass through the opening 31 and be inserted into the urethra 40.

[0029] The distal end of the flexible membrane sac 2 adopts an everted structure design to form an inner sheath portion 21 and an outer everted portion 22, which is connected to the positioner 3. When the straight rod 11 carries the flexible membrane sac 2 into the urethra 40, the everted portion 22 contacts the inner wall of the urethra 40. When the straight rod 11 continues to advance deeper into the urethra 40, the flexible membrane sac 2 flips over proximally relative to the straight rod 11.

[0030] The distal end of the flexible membrane sac 2 adopts an everted structure, and the everted membrane part 22 is connected to the locator 3. The locator 3 is stably fitted onto the outside of the glans penis 4 through the buckle groove 30, which not only achieves precise alignment between the urethral opening 40 and the opening 31, but also provides a reliable fixed support for the everted membrane part 22.

[0031] Using the flexible membrane sac 2 as the contact carrier with the inner wall of the urethra 40 during sampling, sampling is performed through contact and close contact, eliminating mechanical damage to the mucosa caused by rigid friction. The locator 3 plays a role in pre-positioning the inlet head 13 and the opening of the urethra 40, and fixes the flapping part 22. When the straight rod 11 is pushed deeper into the urethra 40, the flexible membrane sac 2 only rolls smoothly proximally relative to the straight rod 11. The flapping part 22 always maintains a gentle fit with the inner wall of the urethra 40, without any additional rotation or impact, completely eliminating the severe pain, burning sensation and foreign body sensation caused by the rotation and friction of traditional swabs.

[0032] Reference Figures 4 to 6 The sampler 1 also includes an inflatable balloon 10, a flexible membrane 2 with a membrane cavity 20, and an airway 12 inside the straight rod 11. One end of the airway 12 is opened on the outer peripheral surface of the straight rod 11 and connects to the membrane cavity 20, and the other end of the airway 12 connects to the inflatable balloon 10. When the inflatable balloon 10 is squeezed, the gas inside the balloon 10 flows into the membrane cavity 20 through the airway 12, driving the flexible membrane 2 to expand and adhere to the inner wall of the urethra 40. When the inflatable balloon 10 is released, the balloon 10 returns to its original shape due to its own elasticity, and the gas inside the membrane cavity 20 flows back to the inflatable balloon 10 through the airway 12, driving the flexible membrane 2 to retract and release the pressure on the inner wall of the urethra 40. By repeatedly squeezing and releasing the inflatable balloon 10, the flexible membrane 2 can generate a periodic squeezing and tapping motion against the inner wall of the urethra 40. The expanded flexible membrane 2 can fully contact the inner wall of the urethra 40, and the tapping motion can allow secretions to flow and be more evenly distributed on the flexible membrane 2. At the same time, this flexible squeezing and tapping method does not damage the structural integrity of the pathogen, and can preserve the original morphology and activity of the pathogen in the sample to the greatest extent, providing a more reliable sample basis for subsequent detection, effectively improving the accuracy of the test results, and reducing the risk of misdiagnosis due to sample quality problems.

[0033] During operation, medical staff can hold the penis and locator 3 with one hand for stable fixation, while using the other hand to smoothly insert the distal end of the sampler 1 through the opening 31 into the urethra 40 until the guide head 13 reaches the lesion location. Sample acquisition is then completed by repeatedly squeezing and releasing the inflatable balloon 10. This invention abandons the traditional method of obtaining samples through rotational friction with swabs. Through the synergistic effect of the inflatable balloon 10 and the flexible membrane sac 2, periodic squeezing and tapping of the inner wall of the urethra 40 is achieved, making the sampling operation easier to master and requiring less proficiency from medical staff.

[0034] The locator 3 is made of medical-grade silicone. Symmetrical grip grooves 32 are provided on both sides of the locator 3 for easy holding. The surface of the grip grooves 32 is curved and has anti-slip textures to increase friction. Medical-grade silicone has good biocompatibility, softness, and skin-friendliness, and will not cause allergic reactions or irritation when in contact with the glans penis 4, improving patient comfort during the sampling process. At the same time, the symmetrical grip grooves 32 on both sides of the locator 3 provide precise force application points for medical personnel to hold and operate the device, allowing them to grip the locator 3 more securely.

[0035] Reference Figure 1 , Figure 3 and Figure 6 The locator 3 is detachably connected to the flap section 22. The flexible membrane sac 2 is discarded along with the sampler 1, while the locator 3 can be reused after cleaning and disinfection, which reduces the cost of medical consumables and the generation of medical waste. The detachable structure allows for the replacement of flexible membrane sac 2 or locator 3 of different sizes to suit the patient's glans penis size 4 and urethral physiological structure 40.

[0036] The locator 3 has an annular groove 33 on its end face facing away from the locking groove 30. The flapping section 22 has a retaining ring 23 that matches the shape of the groove 33, and the retaining ring 23 is embedded in the groove 33. Medical staff can fix the retaining ring 23 of the flapping section 22 into the annular groove 33 of the locator 3 simply by manually pressing it. It can be separated with a little force when disassembling. The operation is simple and quick, without the need for professional tools, which greatly improves the assembly efficiency before sampling and the disassembly and processing efficiency after sampling, and meets the operational needs of rapid clinical sampling.

[0037] Specifically, the gap between the inner circumferential surface of the distal end of the sheath portion 21 and the outer circumferential surface of the straight rod 11, and the gap between the sheath portion 21 and the flap portion 22, are both no greater than 0.5 mm. This prevents the flexible membrane sac 2 from wrinkling before entering the urethra 40 or in the initial stage of insertion, ensuring the continuity of the flexible isolation.

[0038] Reference Figure 4The introducing head 13 is rounded-corner conical. This rounded design completely eliminates the sharp edges of the introducing head 13, avoiding the risk of puncture and scratching of the urethral mucosa during insertion, and further reducing mechanical irritation structurally. The conical structure guides the sampler 1 smoothly into the urethral mucosa along its axis, preventing repeated friction damage. Simultaneously, during rotating sampling, the rounded-corner conical introducing head 13's curved surface forms gentle contact with the lesion site, further reducing pain and burning sensation during sampling while ensuring sufficient sample volume.

[0039] The outer surface of the inlet head 13 is coated with Teflon. Teflon has an extremely low coefficient of friction, significantly reducing friction between the inlet head 13 and the urethral mucosa 40 during insertion and rotation sampling. This effectively reduces mechanical irritation caused by friction, further alleviating patient pain and foreign body sensation. Simultaneously, the Teflon coating exhibits excellent chemical stability and biocompatibility, preventing chemical reactions between the inlet head 13 material and urethral secretions, and reducing the material's own sensitization or inflammatory stimulation of the urethral mucosa 40, thus improving the safety of the sampling process. Furthermore, the smooth surface of the Teflon coating does not easily attract impurities, preventing excess impurities from adhering to the inlet head 13 during sampling and affecting sample purity, ensuring the accuracy of subsequent test results.

[0040] Example 2 like Figure 7 The male urethral pathogen sampling component shown here reduces irritation. This embodiment is based on Embodiment 1, but differs from Embodiment 1 in that: The outer circumferential surface of the insertion head 13 is provided with a plurality of anti-adhesion grooves 5. The anti-adhesion grooves 5 are elongated arc-shaped grooves with rounded corners at the opening. The two ends of the anti-adhesion grooves 5 respectively penetrate the two ends of the insertion head 13. The anti-adhesion grooves 5 are used to reduce the contact area between the insertion head 13 and the urethral mucosa 40, reduce frictional adhesion, avoid mucosal adhesion during insertion / removal of the urethra 40, and greatly improve the smoothness of operation.

[0041] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-disclosed technical content to create equivalent embodiments without departing from the scope of the present invention. Any simple modifications, equivalent changes and alterations made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the scope of the present invention.

Claims

1. A male urethral pathogen sampling device that reduces irritation, characterized in that: Includes a sampler (1) and a locator (3); The sampler (1) has a proximal end and a distal end at its two ends, and the sampler (1) includes a straight rod (11) and a flexible membrane sac (2); the distal end of the straight rod (11) is provided with an inlet head (13) for obtaining pathogens from the urethra (40); the flexible membrane sac (2) is sleeved on the outer periphery of the straight rod (11), and the proximal end of the flexible membrane sac (2) is fixed to the outer peripheral surface of the straight rod (11); The locator (3) has a slot (30) for accommodating the glans (4), and the locator (3) has a port (31) at the position corresponding to the opening of the urethra (40). The locator (3) can be sleeved on the glans (4), and the distal end of the sampler (1) can pass through the port (31) and be inserted into the urethra (40). The distal end of the flexible membrane sac (2) is designed with an everted structure to form an inner sheath portion (21) and an outer everted portion (22), the everted portion (22) being connected to the locator (3); when the straight rod (11) carries the flexible membrane sac (2) into the urethra (40), the everted portion (22) contacts the inner wall of the urethra (40); when the straight rod (11) continues to advance deeper into the urethra (40), the flexible membrane sac (2) rolls up proximally relative to the straight rod (11).

2. The male urethral pathogen sampling component with reduced irritation according to claim 1, characterized in that: The sampler (1) also includes an inflatable balloon (10), the flexible membrane (2) is provided with a membrane cavity (20), the straight rod (11) is provided with an airway (12), one end of the airway (12) is opened on the outer peripheral surface of the straight rod (11) and communicates with the membrane cavity (20), and the other end of the airway (12) is communicated with the inflatable balloon (10); When the inflatable balloon (10) is squeezed, the gas inside the balloon (10) flows into the membrane cavity (20) through the airway (12), driving the flexible membrane (2) to expand and press against the inner wall of the urethra (40); when the inflatable balloon (10) is released, the balloon (10) returns to its original shape by its own elasticity, and the gas inside the membrane cavity (20) flows back to the inflatable balloon (10) through the airway (12), driving the flexible membrane (2) to retract and release the pressure on the inner wall of the urethra (40); by repeatedly squeezing and releasing the inflatable balloon (10), the flexible membrane (2) can generate a periodic squeezing and patting action on the inner wall of the urethra (40).

3. The male urethral pathogen sampling component with reduced irritation according to claim 1, characterized in that: The locator (3) is made of medical-grade silicone material. The two sides of the locator (3) are symmetrically provided with grip grooves (32) for easy gripping. The surface of the grip groove (32) is arc-shaped, and the surface of the grip groove (32) is provided with anti-slip texture to increase friction.

4. The male urethral pathogen sampling component with reduced irritation according to claim 1, characterized in that: The locator (3) is detachably connected to the film-turning part (22).

5. The male urethral pathogen sampling component with reduced irritation according to claim 4, characterized in that: The locator (3) has an annular groove (33) on the end face facing away from the buckle groove (30), and the flipping part (22) has a retaining ring (23) that matches the shape of the groove (33). The retaining ring (23) is embedded in the groove (33).

6. The male urethral pathogen sampling component with reduced irritation according to claim 1, characterized in that: The gap between the inner circumferential surface of the distal end of the film sleeve (21) and the outer circumferential surface of the straight rod (11), and the gap between the film sleeve (21) and the film flipping part (22) are both no greater than 0.5 mm.

7. The male urethral pathogen sampling component with reduced irritation according to claim 1, characterized in that: The inlet head (13) is a rounded cone shape.

8. The male urethral pathogen sampling component with reduced irritation according to claim 1, characterized in that: The outer surface of the inlet head (13) is coated with Teflon.

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