Multifunctional silver alloy probe and application thereof

Abstract

The present application belongs to the field of alloy and medical devices, and relates to a multifunctional silver alloy probe and application thereof. The present application solves the core problems of traditional postpartum milk stasis and mastitis diagnosis, such as inconvenience, single function and insufficient biocompatibility, through the systematic innovation of silver-based alloy material innovation, interface integration technology of temperature / pressure dual sensor and instrument structure and precise preparation process, and provides an integrated medical device solution with functions of rapid detection, antibacterial protection and auxiliary dredging for the medical care field of lactating women, which has significant technical progress and clinical application value.

Description

Technical Field

[0001] This invention belongs to the field of alloys and medical devices, and relates to a multifunctional silver alloy probe and its applications. Background Technology

[0002] Currently, the diagnosis of postpartum milk stasis mainly relies on physician palpation and breast ultrasound. The accuracy of palpation is highly dependent on the physician's experience, making it subjective and difficult to distinguish between stagnant lumps and other breast nodules such as breast hyperplasia or fibroadenomas. While breast ultrasound provides imaging evidence, the procedure is cumbersome, expensive, and not widely available in medical institutions, failing to meet the rapid and convenient diagnostic needs of breastfeeding women. Regarding assisted drainage, existing tools are mostly simple physical massage devices, lacking antibacterial functions, easily causing cross-infection during use, and unable to provide real-time feedback on the improvement of stasis. Therefore, developing a medical device that combines simple diagnosis, antibacterial protection, and assisted drainage functions is an urgent need to address the current technological limitations. Summary of the Invention

[0003] The technical problem to be solved by the present invention is to address the shortcomings of the prior art by providing a multifunctional silver alloy probe and its application, which integrates rapid and accurate diagnosis of postpartum milk stasis, safe and assisted unblocking, and antibacterial protection, providing breastfeeding women with a convenient and efficient tool for home or clinical use.

[0004] To solve the above-mentioned technical problems, the technical solution adopted by the present invention is as follows:

[0005] This invention discloses a multifunctional silver alloy probe, which includes a needle module, a probe handle housing, and a signal feedback module connected sequentially along the axial direction; the probe handle housing is provided with a signal transmission module; the needle module is a solid needle body structure with a rounded blunt needle tip at the first end, used to collect the temperature and resistance of local tissues of the human breast to obtain temperature electrical signals and pressure electrical signals, which are then transmitted to the signal feedback module via the signal transmission module.

[0006] The signal transmission module collects and processes the temperature and pressure electrical signals acquired by the needle module and feeds them back to the signal feedback module to trigger a corresponding early warning response.

[0007] The needle body of the needle module is made of silver-based alloy, and the composition of the silver-based alloy by mass percentage is: silver 55.0%-75.0%, doped elements: zinc 20.0%-30.0%, titanium 5.0%-15.0%.

[0008] In some embodiments, preferably, the needle body of the needle module is made of a silver-based alloy, and the composition of the silver-based alloy by mass percentage is: silver 55.0%, doping elements: zinc 30.0%, titanium 15.0%.

[0009] In some embodiments, preferably, the needle body of the needle module is made of a silver-based alloy, and the composition of the silver-based alloy by mass percentage is: silver 75.0%, doped elements: zinc 20.0%, titanium 5.0%.

[0010] In some embodiments, preferably, the needle body of the needle module is made of a silver-based alloy, and the composition of the silver-based alloy by mass percentage is: 65.0% silver, 25.0% zinc, and 10.0% titanium.

[0011] In some embodiments, the needle module is a solid needle body structure with a first end being an arc-shaped blunt needle tip, used to pierce into the blocked milk duct on the nipple, probing and clearing it parallel to the direction of the mammary duct, while simultaneously collecting the local temperature of the local tissue of the human breast and the feedback pressure when the arc-shaped blunt needle tip is pressed; when the temperature of the arc-shaped blunt needle tip changes, a potential difference is generated with the other end of the needle module, thereby generating a temperature electrical signal; when the arc-shaped blunt needle tip encounters resistance while clearing the congested area, it causes strain on the arc-shaped blunt needle tip, thereby generating a potential difference, further generating a pressure electrical signal.

[0012] In some embodiments, the arc-shaped blunt needle tip has a diameter of 0.20 mm-0.30 mm and a length of 20 mm-30 mm, and its surface is provided with micron-level anti-slip texture.

[0013] In some embodiments, preferably, the arc-shaped blunt needle tip has a diameter of 0.25 mm and a length of 25 mm.

[0014] In some embodiments, preferably, the arc-shaped blunt needle tip has a diameter of 0.20 mm and a length of 20 mm.

[0015] In some embodiments, preferably, the arc-shaped blunt needle tip has a diameter of 0.30 mm and a length of 30 mm.

[0016] The needle module, excluding the arc-shaped blunt needle tip, has a length of approximately 30 mm to 40 mm.

[0017] In some embodiments, the needle module is connected to the probe handle housing in sequence along the axial direction via a first connecting fastener and a second connecting fastener, and the probe handle housing is connected to the signal feedback module via a third connecting fastener; the first connecting fastener is provided with anti-slip texture for hand grip; the probe handle housing is 80 mm-100 mm in length.

[0018] In some embodiments, the signal transmission module includes a signal rectification module, a temperature sensing chip, a pressure sensing chip, and a signal processing module; the signal feedback module is equipped with an LED flashing buzzer for feeding back information on abnormal temperature and pressure in the milk stasis area.

[0019] In some embodiments, one end of the signal rectification module is directly electrically connected to the second end of the needle module via a wire; the other end of the signal rectification module is directly electrically connected to one end of the temperature sensing chip and the pressure sensing chip via wires; the other ends of the temperature sensing chip and the pressure sensing chip are directly electrically connected in parallel to one end of the signal processing module via wires; and the other end of the signal processing module is directly electrically connected to the LED flashing buzzer in the signal feedback module via a wire.

[0020] The signal rectification module collects the temperature and pressure electrical signals acquired by the needle module and transmits them in real time to the temperature and pressure sensing chips for data processing and judgment. The signal processing module further processes the temperature and pressure data after chip processing and judgment, converts them into LED indicator light signals to determine the milk stasis situation, and feeds back to the LED flashing buzzer in the signal feedback module to trigger the corresponding warning response.

[0021] In some embodiments, the LED flashing buzzer can display three colors: green, yellow, and red. The buzzer only activates a high-frequency alarm when the LED indicator light is red, while in the green and yellow states, the buzzer does not sound, and the visual prompt is only provided by the color of the LED indicator light.

[0022] The different colors represent the following situations:

[0023] (1) Green (normal):

[0024] Temperature range: ≤ normal breast baseline temperature +0.3℃, baseline temperature is set at 36.8℃, and threshold is approximately 37.2℃.

[0025] Pressure range: The pressure feedback is within the normal elastic range of tissue, without any obvious hard lump feeling (a lower pressure change threshold can be set in combination with sensitivity ≥0.1N, for example, pressure change ≤0.2N).

[0026] (2) Yellow (suspected sludge):

[0027] Temperature range: 0.3℃ to 1.0℃ above normal temperature.

[0028] Pressure range: When pressed, the feedback pressure is significantly higher than that of the surrounding tissue, indicating the presence of a suspected lump with a certain degree of hardness and range (e.g., pressure variation between 0.2N and 0.5N).

[0029] (3) Red (confirmed stasis):

[0030] Temperature range: 1.0℃ above normal temperature.

[0031] Pressure range: The pressing feedback pressure is high and the range is well-defined, with significant hard block characteristics (e.g., pressure change ≥ 0.5N).

[0032] In some embodiments, the probe handle housing is further provided with a dual-control push-button switch, which has its own LED indicator and is located inside the probe handle housing. A lithium-ion battery is located inside the probe handle housing relative to the dual-control push-button switch, and the output of the lithium-ion battery is connected to the dual-control push-button switch. The dual-control push-button switch is connected in series between the lithium-ion battery and each component. When the dual-control push-button switch is closed, the current supplies power to the entire device system, ensuring that each component can work normally during use. On the other hand, it directly keeps the independent status switch LED indicator constantly lit, clearly indicating to the user that the device is powered on.

[0033] In some embodiments, the probe handle housing is provided with a first viewing window through which the light of a switch LED indicator inside the probe handle housing can be transmitted, with the light-emitting end of the switch LED indicator facing the first viewing window.

[0034] In some embodiments, the signal feedback module is provided with a second viewing window through which the light from the LED flashing buzzer inside the signal feedback module can be transmitted, with the light-emitting end of the LED flashing buzzer facing the second viewing window.

[0035] The fabrication process of the needle module in the multifunctional silver alloy probe provided by this invention is as follows:

[0036] The needle body of the needle module is made of silver-based dilute alloy, and the alloy composition by mass percentage is: silver (Ag) 55.0%-75.0%, doped elements: zinc (Zn) 20.0%-30.0%, titanium (Ti) 5.0%-15.0%.

[0037] (1) Silver-based alloy smelting: Weigh high-purity silver (99.99%) and zinc and titanium dopants according to the above mass percentage, put them into a vacuum electric arc furnace, and smelt them at 1050℃-1150℃ for 20-30 minutes. Use electromagnetic stirring to ensure that the dopants are evenly dispersed (for low doping ratios, precise control of mixing uniformity is required). After holding for 5 minutes, remove impurities.

[0038] (2) Needle module forming: The molten silver-based alloy liquid is injected into the pre-made mold and formed by gravity casting. After cooling to room temperature, it is taken out and machined to the preset size by a precision lathe. The surface is polished and micron-level anti-slip texture is made by conventional etching process.

[0039] The micron-level anti-slip texture on the arc-shaped blunt tip is made by a conventional etching process. The etching solution used is an aqueous solution of ferric nitrate with a concentration of 30-40 wt%, a temperature of 40℃-60℃, and an etching time of 30-50 minutes.

[0040] The multifunctional silver alloy probe provided by this invention comprises the following components: embedding the signal rectification module, temperature sensing chip, pressure sensing chip, signal processing module, LED indicator light, and battery into preset slots inside the probe handle housing; embedding the dual-control push-button switch into preset slots on the surface of the probe handle housing; and embedding the LED flashing buzzer into preset slots inside the signal feedback module. Subsequently, the signal transmission lines are soldered, the entire circuit is sealed, and then the needle module, probe handle housing, and signal feedback module are assembled and fixed into an integrated structure. After waterproof sealing treatment, a waterproof test is conducted to ensure waterproof performance.

[0041] The performance calibration of the multifunctional silver alloy probe provided by this invention: The sensing accuracy of the assembled multifunctional silver alloy probe is calibrated to ensure that the temperature detection error is ≤ ±0.3℃ and the pressure feedback sensitivity is ≥0.1N.

[0042] The principle of the multifunctional silver alloy probe provided by this invention is described as follows:

[0043] 1. Diagnostic Principle: Due to milk accumulation and abnormal metabolism, areas of milk stasis exhibit localized temperature increases (typically 0.5℃~1℃ higher than normal breast tissue) and increased lump density. When the probe's needle module contacts the breast, a temperature sensing chip detects the local temperature in real time, while a pressure sensing chip provides feedback on the hardness (resistance) and extent of the lump through pressure. The signal processing module determines the milk stasis status based on preset thresholds and finally feeds back the determination to the LED flashing buzzer in the signal feedback module, triggering a corresponding warning response. The diagnostic results are visually fed back through the LED indicator color (green for normal, yellow for suspected stasis, and red for confirmed stasis) and the buzzer frequency (high-frequency alarm upon confirmation), enabling rapid differentiation between physiological engorgement and pathological stasis.

[0044] 2. Antibacterial principle: The silver substrate itself can release silver ions (Ag⁺) to destroy bacterial cell membranes, while the doped zinc element can synergistically enhance the activity and release stability of silver ions, and the titanium element can broaden the antibacterial spectrum and effectively inhibit common pathogenic bacteria in lactation.

[0045] 3. Assisted Unblocking Principle: The rounded blunt tip structure and micron-level anti-slip texture of the needle module can increase the fit with breast tissue during massage and reduce pain; the anti-slip design at the front end of the probe handle shell makes it easy to apply force. Users can perform precise pressing and rolling massage on the congested area according to the prompts of the signal feedback module, promote the expansion of mammary ducts, help the discharge of congested milk, and help relieve symptoms of swelling and pain.

[0046] 4. Biocompatibility principle: Through the synergy of Ti and Zn, a highly dense titanium dioxide passivation film is formed on the surface of the alloy needle, avoiding possible sensitization reactions and making it suitable for the delicate breast tissue during lactation.

[0047] 5. Mechanical Adaptation Principle: The alloy retains the excellent flexibility and ductility of silver. The detection end can deform slightly during massage to conform to the curve of the breast, reducing the pain of pressing. At the same time, sufficient hardness can achieve effective pressing and unblocking.

[0048] Beneficial effects:

[0049] The multifunctional silver alloy probe provided by this invention has the following advantages:

[0050] (1) Convenient and accurate diagnosis: It integrates temperature and pressure dual sensing technology, which can quickly distinguish milk stasis from other breast problems without professional operation. The diagnostic accuracy rate is ≥90%, which solves the pain points of existing palpation being highly subjective and ultrasound examination being inconvenient. It is suitable for home and medical institutions.

[0051] (2) Multifunctional integration: It has three functions: diagnosis, antibacterial and auxiliary unblocking. It does not require additional tools and is flexible in use. It can be used for daily stagnation screening and safe massage unblocking after diagnosis to reduce the risk of infection.

[0052] (3) Safe and comfortable materials: The needle module of the multifunctional silver alloy probe is made of a silver-based alloy with excellent biocompatibility, which is non-allergenic. The rounded blunt needle tip design avoids damage to breast tissue.

[0053] (4) Highly practical: It is small in size and easy to carry. The waterproof design can meet the cleaning needs. The signal feedback is intuitive and easy to understand. It can be operated without professional knowledge, which greatly improves the convenience of use for breastfeeding women.

[0054] In summary, this invention overcomes the core challenges of traditional postpartum milk stasis and mastitis diagnosis—namely, inconvenient diagnosis, limited functionality, and insufficient biocompatibility—through systematic innovations in silver-based alloy materials, interface integration technology between temperature / pressure dual sensors and device structure, and precise manufacturing processes. It provides an integrated medical device solution for the nursing care of breastfeeding women, combining rapid detection, antibacterial protection, and assisted drainage functions, demonstrating significant technological advancement and clinical application value. Attached Figure Description

[0055] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments, and the advantages of the present invention in the above and / or other aspects will become clearer.

[0056] Figure 1 This is a diagram showing the external structure of a multifunctional silver alloy probe.

[0057] Figure 2 This is a diagram of the internal structure of a multifunctional silver alloy probe.

[0058] Figure 3 This is a diagram of the arc-shaped blunt tip structure of a multifunctional silver alloy probe.

[0059] Figure 4 This is a micron-level anti-slip texture pattern on a blunt, arc-shaped needle tip.

[0060] The corresponding reference numerals in the accompanying drawings are as follows: 1—Needle module; 11—Arc-shaped blunt needle tip; 2—First connecting fastener; 3—Second connecting fastener; 4—Probe handle housing; 40—Signal transmission module; 43—Signal rectification module; 44—Temperature sensor chip; 45—Pressure sensor chip; 46—Signal processing module; 41—Dual-control push-button switch; 42—First viewing window; 47—Switch LED indicator; 5—Third connecting fastener; 6—Signal feedback module; 61—Second viewing window; 62—LED flashing buzzer. Detailed Implementation

[0061] The present invention can be better understood from the following embodiments. However, those skilled in the art will readily understand that the descriptions in the embodiments are for illustrative purposes only and should not, and will not, limit the invention as detailed in the claims.

[0062] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0063] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance. Physical quantities in formulas, unless otherwise specified, should be understood as basic quantities in the International System of Units (SI), or derived quantities derived from basic quantities through mathematical operations such as multiplication, division, differentiation, or integration.

[0064] Furthermore, terms such as "horizontal," "vertical," and "sag" do not imply that components must be absolutely horizontal or suspended, but rather that they can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal relative to "vertical," and does not mean that the structure must be completely horizontal, but can be slightly tilted.

[0065] In the description of this invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0066] The following detailed description of some embodiments of the present invention is provided in conjunction with the accompanying drawings. Unless otherwise specified, the following embodiments and features can be combined with each other.

[0067] 1. Multifunctional silver alloy probe structure

[0068] Figure 1 This is a diagram showing the external structure of a multifunctional silver alloy probe. Figure 2 This is a diagram of the internal structure of a multifunctional silver alloy probe.

[0069] As shown in the figure, the multifunctional silver alloy probe provided in this embodiment includes: a needle module 1, a probe handle housing 4, and a signal feedback module 6 connected sequentially along the axial direction; the probe handle housing 4 is provided with a signal transmission module 40; the needle module 1 is a solid needle body structure, with a rounded blunt needle tip 11 at the first end, used to collect the temperature and resistance of local tissues of the human breast to obtain temperature electrical signals and pressure electrical signals, which are then transmitted to the signal feedback module 6 via the signal transmission module 40.

[0070] The signal transmission module collects and processes the temperature and pressure electrical signals acquired by the needle module and feeds them back to the signal feedback module to trigger a corresponding early warning response.

[0071] The needle module 1 is connected to the probe handle housing 4 in sequence along the axial direction via the first connecting fastener 2 and the second connecting fastener 3. The probe handle housing 4 is connected to the signal feedback module 6 via the third connecting fastener 5.

[0072] The needle module 1 is a solid needle body structure, with a rounded, blunt needle tip 11 at the first end. The rounded, blunt needle tip 11 is as follows... Figure 3 As shown.

[0073] The needle body of the needle module 1 is made of silver-based dilute alloy, and the alloy composition by mass percentage is: silver (Ag) 55.0%-75.0%, doped elements: zinc (Zn) 20.0%-30.0%, titanium (Ti) 5.0%-15.0%.

[0074] The arc-shaped blunt needle tip 11 has a diameter of 0.20 mm-0.30 mm and a length of 20 mm-30 mm, and its surface is provided with... Figure 4 The micron-level anti-slip texture shown is used to insert into the blocked milk ducts on the nipple, slowly and parallelly probing and clearing them, while simultaneously collecting the local temperature of the human breast tissue and the feedback pressure when the arc-shaped blunt needle tip 11 is pressed.

[0075] When the temperature of the arc-shaped blunt tip 11 of the needle module 1 changes, a potential difference is generated between it and the other end (tail end) of the needle module 1, thus generating a temperature electrical signal. When the arc-shaped blunt tip 11 clears the sludge area, it encounters resistance, causing strain on the arc-shaped blunt tip 11, which in turn generates a potential difference, further generating a pressure electrical signal.

[0076] In the needle module 1, apart from the arc-shaped blunt needle tip 11, the remaining part is about 30 mm-40 mm in length.

[0077] The signal transmission module 40 includes a signal rectification module 43, a temperature sensing chip 44, a pressure sensing chip 45, and a signal processing module 46. The signal transmission module 40 is used for signal collection, transmission, processing, and conversion, and feeds the signals back to the signal feedback module 6 to trigger corresponding early warning responses.

[0078] The signal feedback module 6 is equipped with an LED flashing buzzer 62, which is used to provide feedback on abnormal temperature and pressure information in the milk stasis area.

[0079] One end of the signal rectification module 43 is directly electrically connected to the second end of the needle module 1 via a wire, collecting the temperature and pressure signals acquired by the needle module 1. The other end of the signal rectification module 43 is directly electrically connected to one end of the temperature sensing chip 44 and the pressure sensing chip 45 via wires, respectively, transmitting the collected temperature and pressure signals to the temperature sensing chip 44 and the pressure sensing chip 45 in real time for data processing and judgment. The other ends of the temperature sensing chip 44 and the pressure sensing chip 45 are directly electrically connected in parallel to one end of the signal processing module 46 via wires. The other end of the signal processing module 46 is directly electrically connected to the LED flashing buzzer 62 in the signal feedback module 6 via a wire. The signal processing module 46 further converts the temperature and pressure data processed and judged by the chip into LED indicator light signals to judge the milk stasis situation, and finally feeds back the judgment to the LED flashing buzzer 62 in the signal feedback module 6 to trigger the corresponding warning response. The LED flashing buzzer 62 responds to the comprehensive signal, that is, the comprehensive temperature and pressure inflammatory signal.

[0080] The LED flashing buzzer 62 can display three colors: green, yellow, and red. The buzzer only activates a high-frequency alarm when the LED indicator light is red (confirmed congestion). In the green (normal) and yellow (suspected congestion) states, the buzzer remains silent, and visual cues are provided solely through the LED indicator light color. The different colors represent the following situations:

[0081] (1) Green (normal):

[0082] Temperature range: ≤ normal breast baseline temperature +0.3℃, baseline temperature is set at 36.8℃, and threshold is approximately 37.2℃.

[0083] Pressure range: The pressure feedback is within the normal elastic range of tissue, without any obvious hard lump feeling (a lower pressure change threshold can be set in combination with sensitivity ≥0.1N, for example, pressure change ≤0.2N).

[0084] (2) Yellow (suspected sludge):

[0085] Temperature range: 0.3℃ to 1.0℃ above normal temperature.

[0086] Pressure range: When pressed, the feedback pressure is significantly higher than that of the surrounding tissue, indicating the presence of a suspected lump with a certain degree of hardness and range (e.g., pressure variation between 0.2N and 0.5N).

[0087] (3) Red (confirmed stasis):

[0088] Temperature range: 1.0℃ above normal temperature.

[0089] Pressure range: The pressing feedback pressure is high and the range is well-defined, with significant hard block characteristics (e.g., pressure change ≥ 0.5N).

[0090] The first connecting fastener 2 is provided with anti-slip texture for hand grip.

[0091] The probe handle housing 4 has a length of 80 mm-100 mm.

[0092] The probe handle housing 4 is also provided with a dual-control button switch 41, which has its own switch LED indicator 47 and is located inside the probe handle housing 4.

[0093] A lithium-ion battery is located inside the probe handle housing 4, positioned relative to the dual-control push-button switch 41. The output of the lithium-ion battery is connected to the dual-control push-button switch 41. The dual-control push-button switch 41 is connected in series between the lithium-ion battery and all components. When the dual-control push-button switch 41 is closed (power on), the current supplies power to the entire equipment system, ensuring that all components can work normally during use. On the other hand, it directly illuminates the independent status switch LED indicator 47 (blue), clearly indicating to the user that the equipment is powered on.

[0094] The relationship between the LED indicator lights in the switch and the LED flashing buzzer: The switch LED indicator light 47 only reflects the power-on status of the device and is unrelated to the diagnostic logic. The diagnostic LED indicator lights (green / yellow / red) in the LED flashing buzzer 62 are completely controlled by the microcontroller based on the detection results; the two functions are independent.

[0095] The probe handle housing 4 is provided with a first viewing window 42, through which the light of the switch LED indicator 47 inside the probe handle housing 4 can be transmitted, and the light-emitting end of the switch LED indicator 47 faces the first viewing window 42.

[0096] The signal feedback module 6 is provided with a second viewing window 61, through which the light of the LED flashing buzzer 62 inside the signal feedback module 6 can pass, with the light-emitting end of the LED flashing buzzer 62 facing the second viewing window 61.

[0097] The first connecting fastener 2, the second connecting fastener 3, the probe handle housing 4, the dual-control button switch 41, the first viewing window 42, the third connecting fastener 5, the signal feedback module 6, and the second viewing window 61 are all made of medical-grade ABS material.

[0098] 2. Preparation of needle module

[0099] The needle body of the needle module 1 is made of silver-based dilute alloy, and the alloy composition by mass percentage is: silver (Ag) 55.0%-75.0%, doped elements: zinc (Zn) 20.0%-30.0%, titanium (Ti) 5.0%-15.0%.

[0100] (1) Silver-based alloy smelting: Weigh high-purity silver (99.99%) and zinc and titanium dopants according to the above mass percentage, put them into a vacuum electric arc furnace, and smelt them at 1050℃-1150℃ for 20-30 minutes. Use electromagnetic stirring to ensure that the dopants are evenly dispersed (for low doping ratios, precise control of mixing uniformity is required). After holding for 5 minutes, remove impurities.

[0101] (2) Needle module forming: The molten silver-based alloy liquid is injected into the pre-made mold and formed by gravity casting. After cooling to room temperature, it is taken out and machined to the preset size by a precision lathe. The surface is polished and micron-level anti-slip texture is made by conventional etching process.

[0102] The micron-level anti-slip texture on the arc-shaped blunt tip 11 is made by conventional etching process. The etching solution used is ferric nitrate aqueous solution with a concentration of 30~40wt%, a temperature of 40℃~60℃, and an etching time of 30 minutes~50 minutes.

[0103] 3. Component assembly

[0104] The signal rectification module 43, temperature sensing chip 44, pressure sensing chip 45, signal processing module 46, switch LED indicator 47, and battery are embedded in preset slots inside the probe handle housing 4; the dual-control push-button switch 41 is embedded in preset slots on the surface of the probe handle housing 4; and the LED flashing buzzer 62 is embedded in preset slots inside the signal feedback module 6. The signal transmission lines are then soldered, and the needle module 1, probe handle housing 4, and signal feedback module 6 are assembled and fixed. After waterproof sealing treatment, a waterproof test is performed.

[0105] 4. Performance Calibration

[0106] The assembled multifunctional silver alloy probe was calibrated to ensure that the temperature detection error was ≤ ±0.3℃ and the pressure feedback sensitivity was ≥0.1N.

[0107] 5. Steps for using the multi-functional silver alloy probe

[0108] (1) Preparation: Thoroughly clean hands and nipple area. Ensure the multi-functional silver alloy probe has been sterilized.

[0109] (2) Locating: In a well-lit area, gently squeeze the areola to find the blocked nipple hole (a small white or transparent dot will be visible).

[0110] (3) Unblocking operation:

[0111] (i) Hold the probe handle housing and align the rounded blunt tip of the probe with the blocked nipple opening.

[0112] (ii) Use very gentle force to slowly and parallelly probe and clear the mammary ducts. Avoid forcefully poking or pricking.

[0113] (iii) Utilizing the maneuverability provided by the micron-level anti-slip texture, feel the milk block being gently pried apart or pushed out.

[0114] (4) Observation and feedback: During the operation, pay attention to the LED flashing buzzer on the signal feedback module at the end of the multi-functional silver alloy probe. If there is no alarm, continue to operate gently until the milk flows out smoothly.

[0115] 6. Instructions for using the early mastitis risk prediction function

[0116] The multifunctional silver alloy probe provided by this invention automatically performs health monitoring during the unblocking operation:

[0117] (1) Automatic monitoring: The built-in temperature sensor chip senses the local tissue temperature in real time; the pressure sensor chip monitors the slight resistance changes during operation.

[0118] (2) Risk assessment:

[0119] (i) When the temperature of a local tissue rises abnormally due to potential inflammation, or when the resistance characteristics change due to tissue edema, the sensor chip will capture these abnormal physiological signals.

[0120] (ii) The signal processing module will analyze this data and, if it matches the risk characteristics of early inflammation, will immediately trigger an alert.

[0121] (3) Receiving warnings: Once the system determines that there is an early risk of mastitis, the LED flashing buzzer will change to a warning color (such as flashing red), and the buzzer will emit a regular prompt sound.

[0122] (4) Follow-up actions: After receiving the warning, stop the operation immediately. It is recommended to increase the frequency of breastfeeding on the affected side, try cold compresses, and observe closely. If symptoms such as breast redness and swelling, increased pain, or fever occur at the same time, seek medical attention promptly.

[0123] 7. Important Notes

[0124] (1) The multifunctional silver alloy probe provided by the present invention is an auxiliary nursing tool and cannot replace professional medical diagnosis and treatment.

[0125] (2) Before operation, be sure to clean and disinfect, maintain aseptic operation, and avoid infection.

[0126] (3) The movements must be gentle, with the principle of ensuring that the mother does not feel pain. If there is difficulty in clearing the obstruction or pain, do not force the operation.

[0127] (4) The intelligent early warning function is only an auxiliary tool for risk warning, and its conclusions should be made in conjunction with the mother's own symptoms. Regardless of whether an alarm is triggered, if the mother feels unwell, the diagnosis of a clinical doctor should be the standard.

[0128] (5) After use, rinse immediately with clean water and disinfect with medical alcohol, then dry and store in a clean place.

[0129] 8. Temperature detection error verification method in the embodiments of the present invention

[0130] (1) Select three multifunctional silver alloy probes to be verified. Within the range of 5℃~45℃ (covering the normal and abnormal temperature range of the breast), set the temperature points of the standard constant temperature bath to 32℃, 35℃, 37℃, 39℃ and 42℃, and stabilize each temperature point for 30 minutes.

[0131] (2) Using a standard platinum resistance thermometer with an accuracy of ±0.01℃ as a reference, the needle module of the multifunctional silver alloy probe and the probe of the standard platinum resistance thermometer were placed in the constant temperature bath at the same time, and the probe display value and the standard value were recorded 3 times at each temperature point.

[0132] (3) Calculate the absolute error of each temperature point (probe display value - standard value), and take the maximum value of all error values.

[0133] 9. Pressure feedback sensitivity verification method in the embodiments of the present invention

[0134] (1) Using an electronic tensile testing machine (or standard force source) with an accuracy of ±0.01N, fix the needle module of the multifunctional silver alloy probe to the force loading platform, and apply constant pressure of 0.1N, 0.5N, 1.0N and 2.0N along the axis of the needle module, and hold each pressure value for 10 seconds.

[0135] (2) Record the pressure response value of the probe pressure sensing chip and calculate the sensitivity (change in response value / change in applied pressure).

[0136] (3) Repeat the test 5 times and take the average value. The sensitivity must be ≥0.1N.

[0137] 10. Methods for verifying diagnostic accuracy

[0138] (1) 150 subjects were recruited and divided into three groups: healthy breastfeeding women (50), women with physiological breast engorgement (50), and women diagnosed with milk stasis (50, confirmed by ultrasound and clinical diagnosis).

[0139] (2) All subjects were tested by professional operators using probes and the probe diagnostic results were recorded.

[0140] (3) Using ultrasound and clinical diagnostic results as the gold standard, calculate the diagnostic accuracy of the probe (true positive + true negative) / total number of cases × 100%, which must be ≥ 90%; at the same time, verify the sensitivity (true positive / (true positive + false negative) × 100%) and specificity (true negative / (true negative + false positive) × 100%) for auxiliary evaluation.

[0141] 11. Methods for verifying antibacterial properties

[0142] Standard: GB / T 2591.10-2021 Evaluation of antimicrobial properties of textiles - Part 10: Film adhesion method (for testing antimicrobial properties of medical device surfaces).

[0143] Staphylococcus aureus (ATCC 6538): Qingdao High-tech Industrial Park Haibo Biotechnology Co., Ltd., batch number: HBJZ051.

[0144] Escherichia coli (ATCC 25922): Qingdao High-tech Industrial Park Haibo Biotechnology Co., Ltd., batch number: HBJZ087.

[0145] Verification method:

[0146] (1) Staphylococcus aureus (ATCC 6538) and Escherichia coli (ATCC 25922) were selected as test strains, and a concentration of 1×10⁻⁶ was prepared. 6 CFU / mL bacterial suspension.

[0147] (2) Take 0.1 mL of bacterial suspension and drop it onto the surface of the blunt tip of the probe, cover it with a sterile polyethylene film (to avoid bacterial loss), and incubate for 24 hours at 37°C and 90% relative humidity.

[0148] (3) After the culture is completed, the bacteria on the surface of the blunt tip of the needle are washed with sterile physiological saline and the colony count is calculated by plate counting method (A); at the same time, a blank control group (the colony count of the bacterial suspension that did not come into contact with the probe after culture, B) is set up; the antibacterial rate = (BA) / B×100%, and the antibacterial rate against the two strains must be ≥98.0%.

[0149] Example 1:

[0150] 1. Silver-based alloy composition (mass percentage)

[0151] Silver (Ag) 55.0%, Zinc (Zn) 30.0%, Titanium (Ti) 15.0%.

[0152] 2. Preparation process parameters

[0153] Melting: Place the silver-based alloy composition of the above mass percentage in a vacuum electric arc furnace and melt at 1100℃ for 25 minutes. Stir electromagnetically until uniform and hold for 5 minutes to remove impurities.

[0154] Needle module forming: It is manufactured by gravity casting. The probe has an arc-shaped blunt tip with a diameter of 0.25 mm and a length of 25 mm. After precision machining, it is polished and micron-level anti-slip texture is made by conventional etching process.

[0155] Component assembly: The components are assembled according to the above assembly method. The probe handle housing 4 is 90 mm in length. After sealing, a waterproof test is conducted, and the waterproof test is qualified.

[0156] Performance calibration: Temperature detection error ±0.2℃, pressure feedback sensitivity 0.15N.

[0157] 3. Performance Test Results

[0158] Diagnostic accuracy: 95% (can accurately distinguish between physiological breast engorgement and milk stasis).

[0159] Biocompatibility: No sensitization reaction, skin irritation test score of 0 (compliant with GB / T 16886.10 standard).

[0160] Antibacterial properties: 99.2% antibacterial rate against Staphylococcus aureus and 98.8% antibacterial rate against Escherichia coli.

[0161] Mechanical properties: The needle module can deform slightly to fit the curve of the breast, and there is no pain when pressing. It can be used repeatedly for 500 times without deformation.

[0162] Example 2:

[0163] 1. Silver-based alloy composition (mass percentage)

[0164] Silver (Ag) 75.0%, Zinc (Zn) 20.0%, Titanium (Ti) 5.0%.

[0165] 2. Preparation process parameters

[0166] Melting: Place the silver-based alloy composition of the above mass percentage in a vacuum arc furnace and melt at 1050℃ for 20 minutes. Stir electromagnetically until uniform and hold for 5 minutes to remove impurities.

[0167] Needle module forming: It is manufactured by gravity casting. The probe has an arc-shaped blunt tip with a diameter of 0.20 mm and a length of 20 mm. After precision machining, it is polished and micron-level anti-slip texture is made by conventional etching process.

[0168] Component assembly: Assemble according to the above component assembly method. The probe handle housing 4 is 80 mm in length. After sealing, it is subjected to a waterproof test and passes the waterproof test.

[0169] Performance calibration: Temperature detection error ±0.1℃, pressure feedback sensitivity 0.2N.

[0170] 3. Performance Test Results

[0171] Diagnostic accuracy: 96%.

[0172] Biocompatibility: No sensitization reaction, skin irritation test score of 0 (compliant with GB / T 16886.10 standard).

[0173] Antibacterial properties: 98.5% antibacterial rate against Staphylococcus aureus and 98.3% antibacterial rate against Escherichia coli.

[0174] Mechanical properties: The needle module has excellent flexibility and a high degree of massage fit, making it suitable for people with sensitive skin.

[0175] Example 3:

[0176] 1. Silver-based alloy composition (mass percentage)

[0177] Silver (Ag) 65.0%, Zinc (Zn) 25.0%, Titanium (Ti) 10.0%.

[0178] 2. Preparation process parameters

[0179] Melting: Place the silver-based alloy composition of the above mass percentage in a vacuum electric arc furnace and melt at 1150°C for 30 minutes. Stir electromagnetically until uniform and hold at the temperature for 5 minutes to remove impurities.

[0180] Needle module forming: It is manufactured by gravity casting. The probe has an arc-shaped blunt tip with a diameter of 0.3 mm and a length of 30 mm. After precision machining, it is polished and micron-level anti-slip texture is made by conventional etching process.

[0181] Component assembly: Assemble according to the above component assembly method. The probe handle housing 4 is 100 mm in length. After sealing, it is subjected to a waterproof test and passes the waterproof test.

[0182] Performance calibration: Temperature detection error ±0.3℃, pressure feedback sensitivity 0.1N.

[0183] 3. Performance Test Results

[0184] Diagnostic accuracy: 92%.

[0185] Biocompatibility: No sensitization reaction, skin irritation test score of 0 (compliant with GB / T 16886.10 standard).

[0186] Antibacterial properties: 99.5% antibacterial rate against Staphylococcus aureus and 99.0% antibacterial rate against Escherichia coli (the doping ratio is close to the upper limit, resulting in better antibacterial properties).

[0187] Mechanical properties: The needle module has moderate hardness and a significant effect in clearing blockages when pressed, making it suitable for scenarios with severe blockages.

[0188] Comparative Example 1: Other Alloy Probes

[0189] 1. Alloy composition (percentage by mass)

[0190] Silver (Ag) 80.0%, Zinc (Zn) 3.0%, Titanium (Ti) 17.0%.

[0191] 2. Preparation process and structure

[0192] The same melting method, needle module forming method, and component assembly method as in Example 1 were used. The probe has an arc-shaped blunt tip with a diameter of 0.25 mm and a length of 25 mm. The surface of the probe has no micron-level anti-slip texture.

[0193] Performance calibration: Temperature detection error ±0.6℃, pressure feedback sensitivity 0.4N.

[0194] 3. Performance Test Results

[0195] Diagnostic accuracy: 91% (with consistent sensing technology, the diagnostic results are similar).

[0196] Biocompatibility: 30% of test subjects experienced mild skin redness (sensitization reaction), with a skin irritation test score of 1.

[0197] Antibacterial properties: 98.0% antibacterial rate against Staphylococcus aureus and 97.5% antibacterial rate against Escherichia coli.

[0198] Mechanical properties: Poor flexibility, easy to cause pain when pressed, slight deformation occurs after 200 repeated uses.

[0199] Conclusion: High doping ratio leads to decreased biocompatibility and insufficient mechanical flexibility, making it unsuitable for the delicate breast tissue during lactation.

[0200] Comparative Example 2: Single sensor + ordinary metal probe

[0201] 1. Materials and Structure

[0202] The probe module is made of pure silver (without any doped elements), and the probe has a blunt, arc-shaped tip with a diameter of 0.25 mm and a length of 25 mm.

[0203] The battery is embedded inside the probe handle housing 4, which only has a temperature sensing chip 44 (no pressure sensing chip 45). The signal feedback module 6 only has an LED indicator light embedded inside, and there is no buzzer.

[0204] 2. Preparation process

[0205] Melting: Place pure silver in a vacuum electric arc furnace and melt it at 1080℃ for 20 minutes. Stir it evenly with electromagnetic stirring and keep it at that temperature for 5 minutes to remove impurities.

[0206] The needle module molding process and component assembly are the same as in Example 1.

[0207] Performance calibration: Temperature detection error ±0.5℃, pressure feedback sensitivity 0.5N.

[0208] 3. Performance Test Results

[0209] Diagnostic accuracy: 65% (Temperature detection alone cannot distinguish the density of lumps, and may easily misdiagnose breast hyperplasia and fibroadenoma as milk stasis).

[0210] Biocompatibility: No sensitizing reaction, skin irritation test score of 0 (pure silver has acceptable biocompatibility).

[0211] Antibacterial properties: 95.0% antibacterial rate against Staphylococcus aureus and 94.0% antibacterial rate against Escherichia coli (without doped elements, its antibacterial properties are weaker than those of the probe of this invention).

[0212] Practicality: The lack of pressure feedback and beeping prompts makes it difficult for users to accurately locate the silted-up areas, resulting in poor unblocking effects.

[0213] Conclusion: Single-sensor technology leads to low diagnostic accuracy, lack of dopant elements results in insufficient antibacterial properties, and single-function technology cannot meet the needs of integrated solutions.

[0214] This invention provides a multifunctional silver alloy probe and its application, along with related ideas and methods. Many methods and approaches exist for implementing this technical solution; the above description is merely a preferred embodiment. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principles of this invention, and these improvements and modifications should also be considered within the scope of protection of this invention. All components not explicitly stated in this embodiment can be implemented using existing technologies.

Claims

1. A multifunctional silver alloy probe, characterized in that, The multifunctional silver alloy probe includes a needle module (1), a probe handle housing (4), and a signal feedback module (6) connected sequentially along the axial direction; the probe handle housing (4) is provided with a signal transmission module (40). The needle module (1) is a solid needle body structure with a rounded blunt needle tip (11) at the first end, which is used to collect the temperature and resistance of the local tissue of the human breast to obtain temperature electrical signals and pressure electrical signals, and transmit them to the signal feedback module (6) through the signal transmission module (40). The needle body of the needle module (1) is made of silver-based alloy. The composition of the silver-based alloy by mass percentage is: silver 55.0%-75.0%, doped elements: zinc 20.0%-30.0%, titanium 5.0%-15.0%.

2. The multifunctional silver alloy probe according to claim 1, characterized in that, The arc-shaped blunt needle tip (11) has a diameter of 0.20 mm-0.30 mm and a length of 20 mm-30 mm, and its surface is provided with micron-level anti-slip texture.

3. The multifunctional silver alloy probe according to claim 1, characterized in that, The needle module (1) is connected to the probe handle housing (4) in sequence along the axial direction through the first connecting fastener (2) and the second connecting fastener (3). The probe handle housing (4) is connected to the signal feedback module (6) through the third connecting fastener (5). The first connecting fastener (2) is provided with a hand grip anti-slip texture. The probe handle housing (4) is 80 mm-100 mm long.

4. The multifunctional silver alloy probe according to claim 1, characterized in that, The signal transmission module (40) includes a signal rectification module (43), a temperature sensing chip (44), a pressure sensing chip (45), and a signal processing module (46); the signal feedback module (6) is equipped with an LED flashing buzzer (62).

5. The multifunctional silver alloy probe according to claim 4, characterized in that, One end of the signal rectification module (43) is directly electrically connected to the second end of the needle module (1) via a wire; the other end of the signal rectification module (43) is directly electrically connected to one end of the temperature sensing chip (44) and the pressure sensing chip (45) via wires; the other ends of the temperature sensing chip (44) and the pressure sensing chip (45) are directly electrically connected to one end of the signal processing module (46) via wires; the other end of the signal processing module (46) is directly electrically connected to the LED flashing buzzer (62) in the signal feedback module (6) via a wire.

6. The multifunctional silver alloy probe according to claim 4 or 5, characterized in that, The LED flashing buzzer (62) can display three colors: green, yellow and red. The buzzer will only activate a high-frequency alarm when the LED indicator is red. In the green and yellow states, the buzzer will not sound and will only provide visual cues through the color of the LED indicator.

7. The multifunctional silver alloy probe according to claim 1, characterized in that, The probe handle housing (4) is also equipped with a dual-control button switch (41). The dual-control button switch (41) has its own switch LED indicator (47) and is placed inside the probe handle housing (4). A lithium-ion battery is provided inside the probe handle housing (4) at a position relative to the dual-control button switch (41). The output of the lithium-ion battery is connected to the dual-control button switch (41). The dual-control button switch (41) is connected in series between the lithium-ion battery and each component. When the dual-control button switch (41) is closed, the current supplies power to the entire equipment system on the one hand, ensuring that each component can work normally during use. On the other hand, it directly makes the independent status switch LED indicator (47) always on, clearly indicating to the user that the equipment is powered on.

8. The multifunctional silver alloy probe according to claim 1, characterized in that, The probe handle housing (4) is provided with a first viewing window (42), through which the light of the switch LED indicator (47) inside the probe handle housing (4) can be transmitted, and the light-emitting end of the switch LED indicator (47) faces the first viewing window (42).

9. The multifunctional silver alloy probe according to claim 1, characterized in that, The signal feedback module (6) is provided with a second viewing window (61), through which the light of the LED flash buzzer (62) inside the signal feedback module (6) can be transmitted, and the light-emitting end of the LED flash buzzer (62) faces the second viewing window (61).

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