External urinary catheter with urine-triggered apparatus
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- XIAN WINZISS MEDICAL GRP CO LTD
- Filing Date
- 2025-03-17
- Publication Date
- 2026-05-15
Smart Images
Figure CN2025082967_15052026_PF_FP_ABST
Abstract
Description
An external urinary catheter with a urine triggering device Technical Field
[0001] This invention relates to an external urinary catheter with a urine triggering device for urine collection and drainage in bedridden patients, belonging to the field of medical devices or nursing supplies. Background Technology
[0002] Urination care for long-term bedridden patients is a crucial aspect of patient care. This is especially true for elderly bedridden patients, who typically rely on bedpans, indwelling catheters, or adult diapers. However, these conventional methods have significant negative impacts. For instance, using bedpans for bed urination places a heavy workload on caregivers; prolonged indwelling catheterization increases the risk of urinary tract infections; and long-term use of adult diapers can lead to pressure sores. In recent years, with advancements in materials science and medical care product technology, several external negative pressure suction catheters designed to overcome the shortcomings of existing catheterization techniques have emerged. A representative example is the female catheter launched by BD (Bedi) at the 2024 China International Import Expo in Shanghai. By fixing it around the female urethra and connecting it to a negative pressure pump, it can draw urine into a collection container under negative pressure, a novel approach. However, its drawback is the need for continuous 24-hour operation of the negative pressure pump at the bedside to provide a constant air supply for suction, increasing energy consumption and disrupting the patient's rest.
[0003] To address this, the inventors propose an external urinary catheter with a urine triggering device, filling the gaps in existing external negative pressure suction technology for urine. Summary of the Invention
[0004] This invention relates to an external urinary catheter with a urine triggering device, which mainly includes a leak-proof shell, an absorbent material, a suction cavity, a suction tube, and a urine triggering device.
[0005] The aforementioned leak-proof shell is a waterproof isolation device that is easy for patients to wear or fix around the urethral opening to prevent urine leakage to the periphery. The leak-proof shell has at least one side with a urination window that integrates with the urethral opening. The leak-proof shell is made of flexible waterproof materials such as latex and silicone rubber. The specific shape of the leak-proof shell is not limited, but it should be ergonomic and convenient for patients to wear or fix around the urethral opening. For example, considering the different shapes of male and female genitalia, and combining ergonomics and ease of wear, the leak-proof shell can be manufactured in two models: male and female. The male model uses a sleeve-like or bag-like structure to be worn or fixed around the penis, while the female model uses a bowl-like, disc-like, or rod-like structure to be worn or fixed around the female urinary opening.
[0006] The absorbent material is disposed inside the leak-proof shell, but at least one side of the absorbent material should be located at the urination window of the leak-proof shell, and the absorbent material at the urination window is combined with the patient's urination port. The absorbent material covers or wraps around the periphery of the patient's urethral opening. When the patient urinates, the absorbent material can quickly absorb the urine and guide it into the suction cavity, preventing urine from splashing or overflowing to the periphery of the leak-proof shell.
[0007] In one embodiment, the absorbent material is disposed inside the leak-proof housing, and the absorbent material is embedded in the cavity of the leak-proof housing combined with the urethral opening. The absorbent material can be quickly removed for cleaning or replacement.
[0008] The absorbent material is made of medical-grade flexible materials, including but not limited to medical nonwoven fabrics (such as pure cotton spunlace fabric, perforated hot-air nonwoven fabric, and perforated spunbond nonwoven fabric), sponges, degreased cotton, and synthetic fiber fabrics. Preferably, the absorbent material has a composite structure, with a hydrophobic barrier layer on the surface that contacts the urethral opening and an absorbent layer on the inner surface. The absorbent material contains urine drainage holes or channels. For example, the barrier layer is made of hydrophobic medical nonwoven fabric, which effectively keeps the surface in contact with the patient's urethral opening dry. The inner layer is made of sponge, degreased cotton, or synthetic fiber cotton, which can quickly absorb the patient's urine and guide it into the suction cavity.
[0009] The suction chamber is located downstream of the leak-proof outer shell. Combined with the absorbent material, the suction chamber collects dynamically gathered urine for temporary storage. The shape of the suction chamber is not limited and can include hemispherical, funnel-shaped, etc., with an internal liquid volume of at least 2ml-5ml.
[0010] The suction chamber can be a separate component, assembled downstream of the leak-proof outer shell, or it can be integrally molded with the leak-proof outer shell. For example, in the manufacture of male products, the leak-proof outer shell is made of silicone material in the form of a cylindrical pouch structure (similar to a condom structure). The outer periphery of the pouch is provided with an elastic band or elastic ring, and the bottom of the pouch has a cylindrical suction chamber. The absorbent material is placed above the suction chamber, and the volume of the suction chamber is 3ml-5ml.
[0011] The suction tube is a flexible hollow tube used to drain urine collected in the suction chamber. The head end of the suction tube is integrated with the inside of the suction chamber, and the tail end extends to the outer periphery of the leak-proof outer shell. In one embodiment, absorbent material is wrapped around the outer periphery of the suction tube, the head end of the suction tube is located at the bottom of the suction chamber, the leak-proof outer shell encloses the absorbent material and the suction tube, exposing a 60mm long and 25mm wide window for the absorbent material, and the tail end of the suction tube extends to the outer periphery of the leak-proof outer shell.
[0012] The urine triggering device sent a trigger signal to the core processor on the control board of the negative pressure pump when the patient urinated. This signal caused the core processor to control the operation of the negative pressure pump. It can also be called an automatic trigger switch. The average urination rate for adults is 18 ml / s, with some reaching as high as 24 ml / s. The applicant's research revealed that if conventional sensor technologies (such as humidity sensors and temperature sensors) are used to detect urine output, the inherent hysteresis effect when the sensors obtain reliable detection values causes a missynchronization between the patient's urination and the negative pressure pump's response, resulting in urine spillage. Furthermore, considering the need for daily disposable consumables, conventional sensor technologies are costly and not widely applicable. Therefore, conventional sensor technologies cannot meet the technical requirement of rapidly sensing the patient's urination status and triggering the negative pressure pump in real time.
[0013] The urine triggering device includes at least two electrodes, A and B, and extension wires. The electrodes are microelectrodes, and their specific shapes are not limited, including but not limited to rod-shaped, sheet-shaped, and plate-shaped conductive materials. Depending on the method of liquid sensing and the accuracy of liquid level sensing (e.g., liquid level height, liquid level angle), the urine triggering device can also be constructed using 2-8 electrodes and extension wires, with the number of extension wires corresponding one-to-one with the number of electrodes.
[0014] The following explanation uses two electrodes (Electrode A and Electrode B) as an example: For instance, the head end of extension wire A is connected to both Electrode A and Electrode B, and the tail end of the extension wire has a quick-connect connector. This quick-connect connector connects to and communicates with the control board of the negative pressure pump. The quick-connect connector for communication between the extension wire and the negative pressure pump control board includes, but is not limited to, a DC connector, a USB connector, or an audio connector. To ensure neat wiring of the extension wire and increase tensile strength, in one embodiment, the suction tube is a double-lumen catheter, a triple-lumen catheter, or a double-row tube. The main lumen of the suction tube is used for urine drainage, and the extension wire passes through other secondary lumen channels.
[0015] Depending on how they sense liquid, urine triggering devices can be categorized into electrode-type urine triggering devices and capacitive urine triggering devices.
[0016] The electrodes of the electrode-type urine triggering device are located inside the leak-proof housing, and should be positioned where urine will inevitably flow. The extension wire extends to the outer periphery of the leak-proof housing. Alternatively, the electrodes of the electrode-type urine triggering device can be located inside the absorbent material, at the head of the suction tube, or within the suction chamber, with the extension wire extending to the outer periphery of the leak-proof housing.
[0017] For example, in one embodiment employing two electrodes, the electrode-type urine triggering device consists of two electrodes, A and B, and extension wires. Electrodes A and B are arranged side-by-side or staggered vertically, and must not be short-circuited or touch each other. An extension wire is connected to the tail of each electrode, which is used for communication with the control board of the negative pressure pump. For instance, electrodes A and B are cylindrical copper rods 1-5mm in length and 0.3-1mm in diameter, arranged side-by-side at the head of the suction tube, with a distance of at least 1mm between them. A single-core copper extension wire, 30-80cm in length, is welded to the tail of each electrode; the extension wires should be thin and flexible.
[0018] The working principle of the negative pressure pump controlled by the electrode-type urine triggering device is as follows: at least two electrodes, A and B, are connected and communicate with the control board of the negative pressure pump via extension wires. This forms a closed-loop feedback control circuit with the electrode-type urine triggering device, the control board, and the vacuum pump. The operation and shutdown of the vacuum pump are controlled by the core processor. The control board is equipped with a core processor and a current detection module. The current parameters when electrodes A and B are disconnected are used as the initial value and written into the control program. The current parameters when the two electrodes are connected by urine or simulated urine are used as the control threshold for the core processor to trigger the automatic start of the negative pressure pump and are also written into the control program. The current parameters include current value, voltage value, or resistance value. During the patient's external negative pressure drainage, the core processor uses the current detection module to dynamically measure the current parameters of electrodes A and B and determines the urine discharge or termination state based on the changes in the current parameters. When the core processor senses that the current parameter of electrode A or B has changed to the control threshold, it indicates that electrodes A and B are connected by urine, and it is determined that the patient has discharged urine. The core processor immediately instructs the negative pressure pump to start suction. When the current parameter of pole A or pole B returns to its initial value, it is determined that the patient has finished urinating, and the negative pressure pump stops working or stops working after a delay, and the negative pressure pump returns to standby or hibernation state.
[0019] To further illustrate, consider using the voltage change between electrodes A and B as the control threshold for determining urine discharge and triggering the negative pressure pump. When the negative pressure pump is in standby or sleep mode, the core processor applies a stable voltage (e.g., 3.3V) to electrode A. Electrode B is connected to line D on the control board. When electrodes A and B are disconnected, the initial voltage at electrode B is zero. Due to the good conductivity of urine, measurements show that when electrodes A and B are connected by urine, the voltage at electrode B is between 2.0V and 2.8V. The core processor uses a voltage of 1.5V-3.2V at electrode B as the control threshold for determining that the patient has discharged urine and triggering the negative pressure pump, and writes this into the control program. When urine is discharged and flows through the periphery of the electrode-type urine triggering device, electrodes A and B are connected by the flowing urine. When the core processor senses the voltage at electrode B jump to 2.5V, it determines that the patient has discharged urine and immediately starts the negative pressure pump, which operates according to the preset negative pressure value. After the urine is emptied by negative pressure suction, the A and B poles return to their natural disconnected state, the voltage of the B pole returns to its initial zero value, and the negative pressure pump automatically stops working or stops working after a 1-5 minute delay of suction, and the negative pressure pump returns to standby or hibernation state.
[0020] According to Ohm's Law, V (voltage) = I (current) × R (resistance), similarly, the change in resistance or current value at pole A or B can be used as the control threshold to determine the patient's urine excretion status and trigger the negative pressure pump to start. This can be written into the control program, and examples will not be elaborated here.
[0021] Electrode-type urine triggering devices employing two or more electrodes, such as three to four electrodes, can accurately sense the liquid level or tilt angle. The electrode layout, connection method with the extension wire, and working principle are basically the same as those with two electrodes. It requires maintaining a certain spacing between each pair of electrodes, and the head of the extension wire must be matched and connected to each electrode individually. For example, an electrode-type urine triggering device may use an upright, comb-like structure. Electrodes A and B are used to sense the first liquid level, C and D to sense the second liquid level, E and F to sense the third liquid level, and so on.
[0022] In another embodiment, a capacitive urine triggering device is used. The electrodes of the capacitive urine triggering device have a sheet-like or plate-like structure, and the outer periphery of the electrodes is encapsulated with an insulating plate. The electrodes of the capacitive urine triggering device are located inside or outside the cavity through which the urine flows. For example, the electrodes of the capacitive urine triggering device are located inside or outside the suction cavity, or at the head of the suction tube.
[0023] A capacitive urine triggering device consists of at least two electrodes, A and B, and extension wires. Electrodes A and B are encapsulated in insulating material and arranged separately to create a stable electric field between them. An extension wire is connected to the tail of each electrode, which is used to connect and communicate with the control board of the negative pressure pump. For example, taking a capacitive urine triggering device using electrodes A and B as an example, electrodes A and B are made of 5mm × 10mm × 0.2mm copper or aluminum sheets, fabricated into a semi-circular or C-shaped structure. Electrodes A and B are arranged opposite each other, fixed to the left and right sides of the head end of the suction tube, or arranged separately in the upper and lower or left and right sides of the inner cavity of the suction chamber, with a spacing of 3-8mm between them. A 30-50cm long copper extension wire is welded to the outer periphery of each electrode, which is used to connect and communicate with the control board of the negative pressure pump.
[0024] The working principle of the negative pressure pump controlled by the capacitive urine trigger device is as follows: two electrodes, A and B, construct a stable electric field within or around the urine flow cavity. An extended wire connects to and communicates with the control board of the negative pressure pump, forming a closed-loop feedback control circuit with the capacitive urine trigger device, the control board, and the negative pressure pump. The operation and shutdown of the negative pressure pump are controlled by the core processor. The control board is equipped with a core processor and a capacitance detection module. The capacitance values of electrodes A and B when there is no urine are used as initial values and are written into the control program. The capacitance values of the two electrodes when urine or simulated urine is present are used as the control threshold for the core processor to trigger the automatic start of the negative pressure pump and are also written into the control program. When the core processor senses a sudden increase in the capacitance value between electrodes A and B to the control threshold, it determines that the patient has expelled urine and immediately starts the negative pressure pump to perform suction. When the capacitance value between electrodes A and B returns to the initial value, the negative pressure pump stops working or stops after a delay, and returns to standby or hibernation mode. The following explanation uses a capacitive urine triggering device employing two electrodes, A and B, as an example. For instance, electrode A or electrode B is placed inside the suction chamber, making electrode A one plate of a capacitor, and electrode B, positioned opposite, the other plate. An extension wire connects to and communicates with the control board of the negative pressure pump. The capacitance detection module measures the initial capacitance between electrodes A and B when there is no urine, which is 6000uF. When the patient begins to urinate, urine enters the suction chamber, becoming the dielectric, causing the capacitance value to jump and reach the control threshold of 13000uF. The core processor immediately starts the negative pressure pump, which operates according to a preset negative pressure value. After the urine is emptied by the negative pressure, the capacitance between electrodes A and B decreases to its initial state, and the negative pressure pump automatically stops working or stops working after a delay of 1-5 minutes, returning to standby or hibernation mode.
[0025] Capacitive urine triggering devices employing two or more sets of electrodes can more accurately sense liquid levels. The electrode layout, connection method with extension wires, and working principle are basically the same as those with a single set of electrodes. Each set of electrodes requires insulated encapsulation, maintaining proper spacing between electrodes, and the head of the extension wire is matched and connected to each electrode individually. For example, a capacitive urine triggering device using an upright, comb-like structure can sense the first liquid level using electrodes A and B, the second using electrodes C and D, the third using electrodes E and F, and so on.
[0026] To further improve the integration of drainage consumables, an external urinary catheter with a urine triggering device can be combined downstream with components such as a drainage tube and a negative pressure drainage bottle. The suction tube is connected to the drainage tube and negative pressure drainage bottle to form a complete integrated material for urine sensing, drainage, and collection. In addition to the above-mentioned layout, the urine triggering device can also be installed on the drainage tube or the negative pressure drainage bottle.
[0027] In one embodiment, an external urinary catheter with a urine triggering device includes a leak-proof outer shell, absorbent material, a suction chamber, a suction tube, a urine triggering device, a drainage catheter, and a negative pressure drainage bottle. The urine triggering device is integrated into the drainage catheter or the negative pressure drainage bottle, and can be either an electrode-type urine triggering device or a capacitive urine triggering device.
[0028] For example, an electrode-type urine triggering device is used. Two or more electrodes (A and B poles) are placed within the drainage catheter, specifically in its internal channel. An extension wire connects to these electrodes, extending through a perforation to the outer periphery of the drainage catheter. The tail end of the extension wire has a quick-connect connector for connection to the negative pressure pump control board. When the drainage catheter is combined with the suction tube, the electrodes (A and B poles) extend into the suction chamber via the extension wire, creating an integrated material for urine sensing, drainage, and collection.
[0029] For example, a capacitive urine triggering device can be used. This device is installed on the drainage tube or negative pressure drainage bottle. The extension wire has two or more electrodes, A and B, arranged opposite each other with spacing. The extension wire has a quick connector for connecting to the negative pressure pump control board. When the drainage tube or drainage bottle is combined with the suction tube, the two or more electrodes, A and B, are fixed to the outer periphery of the suction chamber, creating a combined material that integrates urine sensing, drainage, and collection.
[0030] Preferably, the two or more electrodes A and B are constructed into an external structure with a shape and size consistent with the outer periphery of the suction cavity, such as a sleeve, a C-clamp, or an O-ring structure, which can facilitate the fixed installation of the two or more electrodes A and B on the outer periphery of the suction cavity.
[0031] In one embodiment, the capacitive urine triggering device is prepared as a plug-and-play independent component for use with a negative pressure pump or negative pressure drainage device, with two or more electrodes, A and B, fixed on the periphery of the suction cavity to construct a urine sensing and negative pressure drainage system.
[0032] An external urinary catheter with a urine triggering device offers several advantages. It provides a urine triggering device with fast response, high urine detection sensitivity, and extremely low manufacturing cost. The device, along with a control board and a negative pressure pump, forms a closed-loop feedback control circuit for negative pressure suction. Based on changes in current parameters or capacitance when the urine triggering device is activated or deactivated by urine, the circuit senses the patient's initiation or termination of urination and feeds back to control the vacuum pump's operating status. When the urine triggering device is activated by urine, the negative pressure pump responds quickly and initiates negative pressure suction. When urination ends, the urine triggering device automatically deactivates, and the negative pressure pump returns to standby or sleep mode. Compared to methods using liquid level sensors, temperature sensors, or humidity sensors to detect urine, this solution not only has lower manufacturing costs and greater accessibility but also offers high sensitivity in urination status monitoring with a very low probability of distortion or false triggering. The fast negative pressure response time avoids urine overflow problems caused by delayed urine detection or delayed negative pressure activation after urination. This technical solution fills a gap in this field and has significant potential for widespread application. Attached Figure Description
[0033] Figure 1 is a schematic diagram of an embodiment of a female urinary catheter equipped with a capacitive urine triggering device.
[0034] Figure 2 is a schematic diagram of an embodiment of a male urinary catheter equipped with an electrode-type urine triggering device.
[0035] Figure 3 is a schematic diagram illustrating the working principle of a closed-loop feedback circuit combining an electrode-type urine triggering device, a control motherboard, and a negative pressure pump.
[0036] Figure 4 is a schematic diagram illustrating the working principle of a closed-loop feedback circuit combining a capacitive urine triggering device, a control motherboard, and a negative pressure pump.
[0037] Figure 5 is a schematic diagram of an embodiment of a capacitive urine triggering device with a four-sided opposing arrangement of four electrodes.
[0038] Figure 6. Schematic diagram of a linear electrode-type urine triggering device using four electrodes.
[0039] The diagram shows: leak-proof shell (1), adsorbent material (2), suction cavity (3), suction tube (4), A electrode (5), B electrode (6), extension wire (7), extension wire quick connector (8), C electrode (9), D electrode (10), and electrode fixing base (11). Detailed Implementation
[0040] The present invention will now be described in detail with reference to the accompanying drawings and embodiments.
[0041] Example 1: Preparation of a female urinary catheter for a capacitive urine triggering device with a detachable and replaceable adsorbent material (2).
[0042] 1. Material preparation
[0043] 1.1 As shown in Figure 1, a molding die for the leak-proof shell (1) was designed and developed. The applicable material is medical silicone rubber. The overall shape of the leak-proof shell is banana-shaped or rod-shaped, and the suction cavity (3) is located downstream of the leak-proof shell (1). In order to improve the integration of components and reduce assembly procedures, the suction cavity (3) is integrally formed with the leak-proof shell (1).
[0044] 1.2 Design and develop an extrusion mold for the double-lumen suction tube (4), the applicable material being medical soft polyvinyl chloride (PVC). The outer diameter of the double-lumen suction tube (4) is 9mm, the main lumen is the suction chamber (3) with an inner diameter of 6mm; the secondary lumen is used for extending the wiring of the lead wire (7) with an inner diameter of 1.5mm; it is produced by extrusion process and cut into 300mm segments.
[0045] 1.3 The adsorbent material (2) is made of polyurethane sponge. According to the internal shape and space size of the leakproof shell (1), it is cut by die stamping. The adsorbent material (2) is required to fit inside the leakproof shell (1) and not easily fall out naturally.
[0046] 1.4 Electrode A (5) and electrode B (6) are made of copper sheet material with a thickness of 0.1 mm, and are cut into pieces with a length of 8 mm and a width of 5 mm.
[0047] 1.5 The extension conductor (7) uses a 2-core copper wire with an outer diameter of 1.2mm and is cut into segments of 500mm in length.
[0048] 2. Assembly
[0049] 2.1 The two cores at the head of the extension wire (7) are welded to the A electrode (5) and the B electrode (6) respectively. After welding, the A electrode (5), the B electrode (6) and the head of the extension wire (7) are sealed in PVC film using PVC heat sealing process. It is required that the A electrode (5), the B electrode (6) and the head of the extension wire (7) are in an insulated state after sealing.
[0050] 2.2 Using a guide wire, the tail of the extension wire (7) is passed through the secondary cavity of the suction tube (4), so that the extension wire (7) passes through the secondary cavity of the suction tube (4) and the extension of the extension wire (7) is exposed on the outer periphery of the suction tube (4). A DC connector is assembled at the tail of the extension wire (7) using electronic welding and thermoforming processes.
[0051] 2.3 Using medical cyclohexanone adhesive, A electrode (5) and B electrode (6) are respectively bonded to the outer periphery of the head of the suction tube (4), requiring A electrode (5) and B electrode (6) to be arranged facing each other. After bonding, gently pull the extension wire (7) to take all the excess extension wire (7) at the head of the suction tube (4) into the secondary cavity of the suction tube (4).
[0052] 2.4 As shown in Figure 1, the suction tube (4) that has completed the above process is installed inside the leak-proof shell (1). The head of the suction tube (4) is required to enter the suction cavity (3) and the tail of the suction tube (4) extends to the outer periphery of the leak-proof shell (1).
[0053] 2.5 Install the adsorbent material (2) into the inner cavity of the leak-proof shell (1), and ensure that the adsorbent material (2) does not easily fall out naturally.
[0054] 2.6 Packaging is disinfected, and qualified products are put into storage.
[0055] 3. Instructions for use
[0056] 3.1 Connect the end of the suction tube (4) to the drainage tube and the negative pressure drainage bottle, and connect the DC connector at the end of the extension wire (7) to the control board of the negative pressure pump. Turn on the machine to perform fast-response feedback negative pressure drainage control catheterization.
[0057] 3.2 It is recommended to replace or clean the adsorbent material (2) daily. When replacement or cleaning is required, remove the adsorbent material (2) from the leak-proof shell (1) and insert a new or cleaned adsorbent material (2).
[0058] Example 2: Preparation of a male urinary catheter for an electrode-type urine triggering device
[0059] 1. Material preparation:
[0060] 1.1 As shown in Figure 2, a glue injection mold for the leak-proof shell (1) is designed and developed. The applicable material is medical silicone rubber. The overall shape of the leak-proof shell is rod-shaped. The suction cavity (3) is located downstream of the leak-proof shell (1). The suction cavity (3) is provided with a suction tube (4) interface.
[0061] 1.2 Design and develop an extrusion mold for the double-lumen suction tube (4), the applicable material being medical soft polyvinyl chloride (PVC). The outer diameter of the double-lumen suction tube (4) is 9mm, the main lumen is the suction chamber (3) with an inner diameter of 6mm; the secondary lumen is used for extending the wiring of the lead wire (7) with an inner diameter of 1.5mm; it is produced by extrusion process and cut into 300mm segments.
[0062] 1.3 The adsorbent material (2) is prepared as a cylindrical structure with a height of 30 mm and a diameter of 35 mm-40 mm using degreased cotton. It is required that the adsorbent material (2) can be installed in close fit inside the leak-proof shell (1) and is not easy to fall out naturally.
[0063] 1.4 A copper wire with an outer diameter of 1.5 mm is cut into 6 mm long segments to serve as electrode A (5) and electrode B (6).
[0064] 1.5 The extension conductor (7) uses a 2-core copper wire with an outer diameter of 1.2mm and is cut into segments of 500mm in length.
[0065] 2. Assembly
[0066] 2.1 The two cores at the head of the extension wire (7) are welded to the tails of electrode A (5) and electrode B (6) respectively. After welding, silicone is used to separate the tails of electrode A (5) and electrode B (6) with a spacing of 2-5 mm. The heads of electrode A (5) and electrode B (6) are exposed, and the welding points between the tails of electrode A (5) and electrode B (6) and the head of the extension wire (7) are in an insulated state.
[0067] 2.2 Using a guide wire, the tail of the extension wire (7) is passed through the secondary cavity of the suction tube (4), so that the extension wire (7) passes through the secondary cavity of the suction tube (4) and the extension of the extension wire (7) is exposed on the outer periphery of the suction tube (4). A DC connector is assembled at the tail of the extension wire (7) using electronic welding and thermoforming processes.
[0068] 2.3 Using medical adhesive, attach electrode A (5) and electrode B (6) to the outer periphery of the head of the suction tube (4). After attachment, gently pull the extension wire (7) to draw all the excess extension wire (7) from the head of the suction tube (4) into the secondary cavity of the suction tube (4).
[0069] 2.4 Using medical adhesive, the head of the suction tube (4) is assembled and installed at the bottom of the leak-proof shell (1). The head of the suction tube (4) is required to be connected to the inside of the suction cavity (3), and the A electrode (5) and B electrode (6) are completely enclosed at the bottom of the suction cavity (3).
[0070] 2.5 Install the adsorbent material (2) into the inner cavity of the leak-proof shell (1), and ensure that the adsorbent material (2) does not easily fall out naturally.
[0071] 2.6 Packaging is disinfected, and qualified products are put into storage.
[0072] Example 3: A capacitive urine triggering device with a four-sided opposing arrangement of four electrodes.
[0073] 1. As shown in Figure 5, develop and manufacture an injection mold for an electrode fixing base (11). The electrode fixing base (11) is a perfect circle with an inner diameter of 6mm, a wall thickness of 1mm, and a height of 2.0mm.
[0074] 2. Use copper sheet with a thickness of 0.2mm to make electrode sheets, and cut them into small rectangular pieces with a length of 6mm and a width of 2mm for later use.
[0075] 3. Using a metal inlay injection molding process, four electrode pieces are injection molded into one piece with the electrode fixing base (11). Among them, electrode A (5) and electrode B (6) are arranged side by side, and electrode C (9) and electrode D (10) are arranged vertically. The lateral distance between two adjacent electrodes is not less than 2mm. The tail of each electrode protrudes 0.5mm from the electrode fixing base (11).
[0076] 4. Using a four-core extension wire (7), the tail of the electrode (exposing the electrode fixing base (11)) is welded to the head of one of the cores of the extension wire (7) using electronic welding technology. It is required that there is no false welding or solder joint burrs.
[0077] 5. Apply insulating paint to the welded joints of the four electrode plates and the extension wire (7), ensuring that there is no leakage current at the welded joints of each electrode and the extension wire (7).
[0078] 6. At the end of the extension wire (7), an extension wire (7) quick connector is assembled and packaged, the quick connector being a USB connector.
[0079] The above figures and embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. The electrode numbers A, B, C, and D in the specification are only used to distinguish different electrodes, and the terms "upper," "lower," "left," and "right" are only used to distinguish different positions and are not intended to limit the names. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the spirit and scope of the present invention. All such modifications or substitutions should be covered within the scope of the claims of the present invention and do not constitute any limitation on the scope of protection of the present invention.
Claims
1. An external urinary catheter with a urine triggering device, mainly comprising a leak-proof shell (1), an absorbent material (2), a suction cavity (3), a suction tube (4), and a urine triggering device, wherein the leak-proof shell (1) is a waterproof isolation device that is easy for the patient to wear or fix around the urethral opening to prevent urine leakage to the periphery, the absorbent material (2) is disposed inside the leak-proof shell (1), the suction cavity (3) is disposed downstream of the leak-proof shell (1), and the head end of the suction tube (4) is combined with the inside of the suction cavity (3), characterized in that: The leak-proof housing (1) has at least one side with a urination window combined with the urethral opening, and the urine triggering device includes at least two electrodes, A and B, and an extension wire (7); depending on the way the urine triggering device senses liquid, the urine triggering device includes an electrode-type urine triggering device and a capacitive urine triggering device; The negative pressure suction closed-loop feedback control circuit, consisting of the urine trigger device, control motherboard, and vacuum pump, senses the patient's urination start or cessation state based on the current parameter or capacitance change of the urine trigger device when it is turned on or off by urine, and feeds back to control the working state of the vacuum pump. When the urine trigger device is turned on by urine, the negative pressure pump responds quickly and starts negative pressure suction. When urination ends, the urine trigger device automatically disconnects, and the negative pressure pump returns to standby or hibernation state.
2. The external urinary catheter with a urine triggering device according to claim 1, characterized in that: The adsorbent material (2) is placed inside the leak-proof shell (1), and the adsorbent material (2) is embedded in the cavity of the leak-proof shell (1) and the urethral opening. The adsorbent material (2) can be quickly removed for cleaning or replacement.
3. The external urinary catheter with a urine triggering device according to claim 1, characterized in that: The adsorbent material (2) adopts a composite structure. The surface layer of the adsorbent material (2) that contacts the urethral opening is a hydrophobic isolation layer, and the inner layer is a water-absorbing layer. The adsorbent material (2) has urine diversion holes or diversion channels inside.
4. The external urinary catheter with a urine triggering device according to claim 1, characterized in that: The suction tube (4) is a double-lumen tube, a triple-lumen tube, or a double-row tube. The main lumen of the suction tube (4) is used for urine drainage, and the extension wire (7) is laid out through other secondary lumens.
5. An external urinary catheter with a urine triggering device according to claim 1, characterized in that: The electrodes of the electrode-type urine triggering device are located inside the leak-proof housing (1), and the electrodes should be located in the areas through which urine will inevitably flow. The extension wire (7) extends to the outer periphery of the leak-proof housing (1).
6. An external urinary catheter with a urine triggering device according to claim 1, characterized in that: The electrodes of the capacitive urine triggering device adopt a sheet or plate structure, and the outer periphery of the electrodes is encapsulated with an insulating plate. The electrodes of the capacitive urine triggering device are placed in the cavity or on the outer periphery of the cavity through which urine flows.
7. An external urinary catheter with a urine triggering device according to claim 1, characterized in that: It can also combine components such as drainage tubes and negative pressure drainage bottles downstream. The suction tube (4) is combined and connected with the drainage tube and negative pressure drainage bottle to form a complete combination material integrating urine sensing, drainage and collection. In addition to the above-mentioned layout, the urine triggering device can also be set on the drainage tube or negative pressure drainage bottle.
8. An external urinary catheter with a urine triggering device according to claim 1, characterized in that: The capacitive urine triggering device is prepared as a plug-and-play independent component that can be used with a negative pressure pump or negative pressure drainage device. Two or more electrodes, A and B, are fixed on the outer periphery of the suction cavity (3) to construct a urine sensing and negative pressure drainage system.
9. The working principle of the negative pressure pump using an electrode-type urine trigger device feedback control is as follows: at least two electrodes, A and B, are used. The electrode-type urine trigger device, the control motherboard, and the vacuum pump form a closed-loop feedback control circuit. The operation and shutdown of the vacuum pump are controlled by the core processor. During the patient's external negative pressure drainage, the core processor uses a current monitoring chip to dynamically measure the current parameters of the two electrodes, A and B. When the core processor senses that the current parameter of electrode A or B jumps to the control threshold, it determines that the patient has expelled urine, and the core processor immediately instructs the negative pressure pump to perform suction. When the current parameter of electrode A or B returns to the initial value, it determines that the patient's urination has ended, and the negative pressure pump stops working or stops working after a delay, returning to standby or hibernation state.
10. The working principle of the negative pressure pump operation controlled by the feedback of the capacitive urine trigger device is that the two electrodes A and B construct a stable electric field in the cavity or periphery of the cavity through which the urine flows. The extended wire (7) is connected to the control board of the negative pressure pump and communicates with it, so that the capacitive urine trigger device, the control board and the negative pressure pump form a closed-loop feedback control circuit. The operation and stop of the negative pressure pump are controlled by the core processor. When the core processor senses that the capacitance value between the two electrodes A and B suddenly increases to the control threshold, it judges that the patient has excreted urine and the core processor immediately starts the negative pressure pump to perform suction work. When the capacitance value between the two electrodes A and B returns to the initial value, the negative pressure pump stops working or stops working after a delay and the negative pressure pump returns to the standby or hibernation state.