External urinary catheter with urine triggering device

Abstract

The invention relates to an external urethral catheter with a urine triggering device. The external urethral catheter mainly comprises an anti-leakage shell, an adsorption material, a suction cavity, a suction tube and the urine triggering device. Compared with a technical mode of sensing urine by adopting a liquid level sensor, a temperature sensor, a humidity sensor and the like, the prepared nursing consumables are lower in cost and high in universality, the urination state monitoring sensitivity is high, the distortion or false triggering probability is extremely low, the starting negative pressure response time is short, and the nursing consumables can be used for nursing. The problem of urine overflow caused by urine sensing delay or negative pressure starting lag after urination is avoided.

Description

Technical Field

[0001] The invention relates to an external urinary catheter with a urine triggering device, which is used for urine collection and drainage of bedridden patients and belongs to the field of medical devices or nursing products. Background Art

[0002] Urinary care for long-term bedridden patients is an important topic in patient care. Especially for elderly bedridden patients, urination in bed is usually done by means of urinary basin, indwelling catheter or wearing diapers. However, the negative effects of these conventional nursing methods are also prominent. For example, urinating in bed with urinary basin requires a lot of work intensity for nursing staff; long-term indwelling catheter is prone to urinary tract infection, and long-term use of diapers is prone to bedsores. In recent years, with the continuous advancement of materials science and medical care product technology, some negative pressure suction catheters designed to overcome the shortcomings of existing catheterization technology and used in vitro have emerged. Among them, the more representative one is the female catheter released by BD (Bichardson) of the United States at the 2024 Shanghai Import Expo. As long as it is fixed on the periphery of the female urethral orifice and connected to a negative pressure pump, urine can be negatively pressured into the urine collection container, which is refreshing. However, its technical disadvantage is that it is necessary to run a negative pressure pump continuously for 24 hours beside the bed to continuously provide a negative pressure suction gas source for the catheter, which not only increases energy consumption, but also affects the quiet rest of bedridden patients.

[0003] To this end, the inventors propose an external urinary catheter with a urine triggering device to fill the deficiencies in the existing urine extracorporeal negative pressure suction technology. Summary of the invention

[0004] The invention relates to an external urinary catheter with a urine triggering device, which mainly comprises an anti-leakage shell, an adsorbent material, a suction cavity, a suction tube and a urine triggering device.

[0005] The anti-leakage shell is a waterproof isolation device that is convenient for patients to wear or fix around the urethral opening to prevent urine from leaking to the periphery. At least one side of the anti-leakage shell is provided with a urination window combined with the urethral opening. The anti-leakage shell is made of flexible waterproof materials including latex, silicone rubber, etc. The specific shape of the anti-leakage shell is not limited, so as to conform to ergonomics and facilitate patients to wear or fix around the urethral opening. For example, according to the different shapes of the male and female vulva parts, combined with ergonomics and the convenience of wearing, the anti-leakage shell is prepared into two models for men and women. The male model adopts a sleeve-shaped or bag-shaped structure, which is worn or fixed around the penis, and the female model adopts a bowl-shaped, disc-shaped or rod-shaped structure, which is worn or fixed around the female urination opening.

[0006] The absorbent material is arranged inside the anti-leakage shell, but at least one side of the absorbent material should be located at the urination window of the anti-leakage shell, and the absorbent material at the urination window is combined with the patient's urination opening. 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 urine and guide it into the suction cavity to prevent urine from splashing or overflowing to the periphery of the anti-leakage shell.

[0007] In one embodiment, the adsorbent material is disposed inside the anti-leakage shell, and the adsorbent material is embedded in the inner cavity of the anti-leakage shell and the urethra opening combination, so that the adsorbent material can be quickly taken out for cleaning or replacement.

[0008] The adsorbent material is made of medical flexible material, including but not limited to medical non-woven fabrics (such as pure cotton spunlace fabrics, perforated hot air non-woven fabrics, perforated spunbond non-woven fabrics), sponges, absorbent cotton and chemical fiber fabrics. Preferably, the adsorbent material adopts a composite structure, the surface layer of the adsorbent material in contact with the urethral opening is a hydrophobic isolation layer, the inner layer is a water-absorbing layer, and the adsorbent material is provided with urine diversion holes or diversion grooves. For example, the isolation layer is made of hydrophobic medical non-woven fabric, which can effectively keep the contact surface with the patient's urethral opening dry. The inner layer is made of sponge, absorbent cotton or chemical fiber cotton, which can quickly absorb the patient's urine and divert it into the suction cavity.

[0009] The suction chamber is arranged at the downstream position of the anti-leakage shell, and the suction chamber is combined with the adsorbent material to collect the dynamically collected urine into the suction chamber for temporary storage. The shape of the suction chamber is not limited, and can be a hemispherical shape, a funnel shape, etc., and the interior of the suction chamber has a liquid volume of at least 2ml-5ml.

[0010] The suction chamber can be an independent component, combined and arranged downstream of the anti-leakage shell, or it can be integrally formed with the anti-leakage shell. For example, when preparing a male product, the anti-leakage shell adopts a cylindrical bag structure (similar to a condom structure) made of silicone material, an elastic band or elastic ring is arranged on the outer periphery of the bag, a cylindrical suction chamber is arranged at the bottom of the bag, and the adsorption material is arranged above the suction chamber, and the volume of the suction chamber is 3ml-5ml.

[0011] The suction tube is a flexible hollow pipe used to drain urine collected in the suction cavity to the outside, the head end of the suction tube is combined with the inside of the suction cavity, and the tail end of the suction tube extends to the periphery of the anti-leakage shell. In one embodiment, the adsorbent material is wrapped around the periphery of the suction tube, the head end of the suction tube is arranged at the bottom of the suction cavity, the anti-leakage shell encloses the adsorbent material and the suction tube, and an adsorbent material exposure window with a length of 60 mm and a width of 25 mm is exposed, and the tail end of the suction tube extends to the periphery of the anti-leakage shell.

[0012] The urine trigger device is a sensing device that sends a trigger signal to the core processor on the control motherboard of the negative pressure pump when the patient has urine discharged, so that the core processor controls the working state of the negative pressure pump according to the trigger signal. It can also be called an automatic trigger switch. The average urination rate of an adult is 18 ml per second, and some are as high as 24 ml per second. After authenticity research, the applicant found that if conventional sensor technology (such as humidity sensor, temperature sensor, etc.) is used to sense the discharge of urine, due to the hysteresis effect that cannot be eliminated when the sensor obtains a reliable detection value, the patient's urination and the negative pressure pump response speed cannot be synchronized, causing the discharged urine to overflow. At the same time, considering the disposable consumables that are replaced once a day, the conventional sensor technology has a high cost of use and is not inclusive. Therefore, the use of conventional sensor technology cannot meet the technical requirements of rapid perception of the patient's urination status and real-time stimulation of the negative pressure pump to start working.

[0013] The urine trigger device includes at least two electrodes A and B and an extension wire. The electrodes are microelectrodes, and the specific shape of the electrodes is not limited, including but not limited to rod-shaped, sheet-shaped, and plate-shaped conductive materials. According to the different requirements of the urine trigger device for sensing liquid and the accuracy of sensing liquid level (such as liquid level height, liquid level inclination), the urine trigger device can also be constructed with 2-8 electrodes and extension wires, and the number of extension wires corresponds to the number of electrodes.

[0014] The following is an explanation using two electrodes (electrode A and electrode B) as an example: for example, the head end of extension wire A is connected to electrode A and electrode B respectively, and the tail end of the extension wire is provided with a quick connector, which is connected to and communicates with the control mainboard of the negative pressure pump. The quick connector for connecting and communicating the extension wire to the mainboard of the negative pressure pump includes but is not limited to a DC connector, a USB connector or an audio connector. In order to make the extension wire wiring neat and increase the tensile strength, in one embodiment, the suction tube is a double-lumen catheter, a triple-lumen catheter or a double-row tube, and the main lumen of the suction tube is used for urine drainage, and the extension wire is laid out through other secondary lumens.

[0015] According to different ways in which the urine trigger device senses liquid, the urine trigger device includes an electrode type urine trigger device and a capacitive type urine trigger device.

[0016] The electrode of the electrode-type urine trigger device is arranged inside the anti-leakage shell, and the electrode should be arranged at the position where urine must flow through, and the extension wire extends to the periphery of the anti-leakage shell. The electrode of the electrode-type urine trigger device is arranged inside the adsorbent material, or at the head end of the suction tube, or in the inner cavity of the suction cavity, and the extension wire extends to the periphery of the anti-leakage shell.

[0017] For example, in an embodiment using two electrodes, the electrode-type urine trigger device is composed of two electrodes, pole A and pole B, and an extension wire. Pole A and pole B are arranged in a left-right layout or an up-down staggered layout, and must not be short-circuited or touch each other. The tails of pole A and pole B are respectively connected to an extension wire, and the extension wire is used to connect and communicate with the control motherboard of the negative pressure pump. For example, pole A and pole B are cylindrical copper rods with a length of 1-5mm and a diameter of 0.3-1mm. Pole A and pole B are arranged in left and right rows at the head end of the suction tube, and the spacing between pole A and pole B is not less than 1mm; the tails of pole A and pole B are respectively welded with a single-core copper extension wire with a length of 30-80cm, and the extension wire should be thin and soft.

[0018] The working principle of using an electrode-type urine trigger device to feedback control the operation of a negative pressure pump is that at least two electrodes A / B are used, and the extension wire is connected and communicated with the control mainboard of the negative pressure pump, so that the electrode-type urine trigger device, the control mainboard and the vacuum pump form a closed-loop feedback control circuit, and the operation and stop of the vacuum pump are controlled by the core processor. The control mainboard is provided with a core processor and a current detection module. The current parameters when the two 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 written into the control program. The current parameters include current value, voltage value or resistance value. During the patient's extracorporeal negative pressure drainage, the core processor uses the current detection module to dynamically measure the current parameters of the two electrodes A and B, and judges the discharge or termination state of urine according to the jump of the current parameters. When the core processor senses that the current parameter of the A or B pole jumps to the control threshold, it means that the A pole and the B pole are connected by urine, and it is judged that the patient discharges urine, and the core processor immediately instructs the negative pressure pump to perform suction work. When the current parameter of the A pole or the B pole returns to the initial value, it is determined that the patient has finished urinating, the negative pressure pump stops working or stops working with a delay, and the negative pressure pump returns to the standby or dormant state.

[0019] To further illustrate, for example, the voltage change of the two electrodes A and B is used as the control threshold for judging urine discharge and triggering the start of the negative pressure pump. When the negative pressure pump is in standby or dormant state, the core processor loads a stable voltage value (such as 3.3V) to the A pole, and the B pole is connected to the D line of the control mainboard. When the two electrodes A and B are disconnected, the initial value of the B pole voltage is zero. Due to the good conductivity of urine, it is measured that when the two electrodes A and B are connected by urine, the voltage of the B pole is between 2.0V and 2.8V. The core processor uses the B pole voltage of 1.5V-3.2V as the control threshold for judging whether the patient discharges urine and triggering the start of the negative pressure pump, and writes the control program. When the patient's urine is discharged and flows through the periphery of the electrode-type urine trigger device, the A pole and the B pole are connected by the urine flowing through. When the core processor senses that the voltage of the B pole jumps to 2.5V, it is judged that the patient has urine discharge, and the core processor immediately starts the negative pressure pump, and the negative pressure pump works according to the pre-set negative pressure value. After the urine is emptied by negative pressure suction, poles A and B return to a naturally disconnected state, the voltage of pole B returns to the initial zero value, the negative pressure pump automatically stops working or stops working after a delayed suction of 1-5 minutes, and the negative pressure pump returns to standby or sleep mode.

[0020] According to Ohm's law, V (voltage) = I (current) × R (resistance), similarly, the change in the resistance value or current value of pole A or pole B can be used as a control threshold to determine the patient's urine discharge status and trigger the start of the negative pressure pump and write it into the control program. I will not go into details one by one with examples.

[0021] An electrode-type urine trigger device using more than two electrodes, such as 3-4 electrodes, can accurately sense the height of the liquid level or the inclination angle of the liquid level. The layout of the electrodes, the connection method with the extension wire, and the working principle are basically the same as those of two electrodes. It is required that the layout spacing between each pair of electrodes be maintained, and the head of the extension wire is matched and connected to each electrode one by one. For example, the electrode-type urine trigger device adopts an upright comb-like structure layout, with poles A and B used to sense the first liquid level, poles C and D used to sense the second liquid level, poles E and F used to sense the third liquid level, and so on.

[0022] In another embodiment, a capacitive urine triggering device is used, and the electrodes of the capacitive urine triggering device are in a sheet or plate structure, and the periphery of the electrodes is encapsulated by an insulating plate. The electrodes of the capacitive urine triggering device are arranged in the cavity or the periphery of the cavity through which urine flows. For example, the electrodes of the capacitive urine triggering device are arranged inside the suction cavity or the periphery of the suction cavity, or are arranged at the head of the suction tube.

[0023] The capacitive urine trigger device is composed of at least two electrodes A and B and an extension wire. The two electrodes A and B are encapsulated with insulating materials and arranged separately, so that a stable electric field is constructed between the two electrodes A and B or multiple electrodes. The tails of the two electrodes A and B are respectively connected to an extension wire, and the extension wire is used to connect and communicate with the control motherboard of the negative pressure pump. For example, taking the capacitive urine trigger device using the two electrodes A and B as an example, the two electrodes A and B are made of 5mm×10mm×0.2mm copper or aluminum metal sheets, prepared into a semicircular or C-shaped structure, and the two electrodes A and B are arranged oppositely, respectively fixed on the left and right sides of the head end of the suction tube, or separated and arranged above and below or left and right of the inner cavity of the suction chamber, and the spacing between the two electrodes A and B is 3-8mm. A copper extension wire with a length of 30-50cm is welded to the periphery of the two electrodes A and B, and the extension wire is used to connect and communicate with the control motherboard of the negative pressure pump.

[0024] The working principle of the negative pressure pump operation controlled by the capacitive urine trigger device feedback is that the two electrodes A and B construct a stable electric field in the cavity or the periphery of the cavity through which urine flows, and the extended wire is connected and communicated with the control mainboard of the negative pressure pump, so that the capacitive urine trigger device, the control mainboard and the negative pressure pump form a closed-loop feedback control circuit, and the operation and stop of the negative pressure pump are controlled by the core processor. The control mainboard is provided with a core processor and a capacitance detection module, and the capacitance value of the two electrodes A and B when there is no urine is used as the initial value and written into the control program; the capacitance value when the two electrodes are connected by urine or simulated urine is used as the control threshold for the core processor to trigger the automatic start of the negative pressure pump and written into the control program. When the core processor senses that the capacitance value between the two electrodes A and B suddenly increases to the control threshold, it is judged that the patient has discharged urine, and the core processor immediately starts the negative pressure pump for suction. 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 with a delay, and the negative pressure pump returns to the standby or dormant state. The following further illustrates the capacitive urine trigger device using two electrodes A and B as an example. For example, the A electrode or the B electrode is set in the inner cavity of the suction chamber, so that the A electrode becomes one plate of the capacitor, and the relatively arranged B electrode serves as the other plate. The extended wire is connected and communicated with the control mainboard of the negative pressure pump. The capacitance detection module measures the initial capacitance value of 6000uF between the two electrodes A and B when there is no urine. When the patient starts to urinate and the urine enters the suction chamber, the urine in the suction chamber becomes a dielectric medium, causing the capacitance value to jump and reach the control threshold of 13000uF. The core processor immediately starts the negative pressure pump, and the negative pressure pump works according to the pre-set negative pressure value. After the urine is emptied by negative pressure suction, the capacitance value between the two electrodes A and B is reduced to the initial state, and the negative pressure pump automatically stops working or stops working after a delay of 1-5 minutes, and the negative pressure pump returns to standby or dormant state.

[0025] A capacitive urine trigger device that uses more than two sets of electrodes can sense the liquid level more accurately. The layout of the electrodes, the connection method with the extension wire, and the working principle are basically the same as those of a single set of electrodes. Each set of electrodes must be insulated and packaged, the layout spacing between the electrodes must be maintained, and the head of the extension wire must be matched and connected to each electrode one by one. For example, the capacitive urine trigger device uses an upright comb-like structure layout, with electrodes A and B used to sense the first liquid level, electrodes C and D used to sense the second liquid level, electrodes E and F used to sense the third liquid level, and so on.

[0026] In order to further improve the integration of drainage consumables, an external urinary catheter with a urine trigger device can also be combined with a drainage catheter, a negative pressure drainage bottle and other components downstream thereof, and the suction tube is connected with the drainage catheter and the negative pressure drainage bottle to form a complete combined material for urine sensing, drainage and collection. In addition to the above-mentioned layout, the urine trigger device can also be set on the drainage catheter or the negative pressure drainage bottle.

[0027] In one embodiment, an external urinary catheter with a urine trigger device includes a leak-proof shell, an adsorbent material, a suction chamber, a suction tube, a urine trigger device, a drainage catheter, and a negative pressure drainage bottle. The urine trigger device is combined and arranged on the drainage catheter or the negative pressure drainage bottle, and the urine trigger device is divided into two types: an electrode-type urine trigger device and a capacitive-type urine trigger device.

[0028] For example, an electrode-type urine trigger device is used, in which two or more electrodes, pole A and pole B, are arranged in the drainage catheter and in the internal channel of the drainage catheter, the head end of the extension wire is connected to the two or more electrodes, pole A and pole B, the extension wire is perforated and extends to the periphery of the drainage catheter, and the tail end of the extension wire is provided with a quick connector connected to the negative pressure pump control mainboard. When the drainage catheter is combined and connected with the suction tube, the two or more electrodes, pole A and pole B, are extended to the interior of the suction cavity by the extension wire, so as to construct a combined material integrating urine sensing, drainage and collection.

[0029] For another example, a capacitive urine trigger device is used. The capacitive urine trigger device is set on the drainage catheter or negative pressure drainage bottle. The head end of the extension wire is provided with two or more electrodes A and B. The two or more electrodes A and B are arranged opposite to each other and separated from each other. The tail end of the extension wire is provided with a quick connector connected to the negative pressure pump control motherboard. When the drainage catheter or drainage bottle is combined and connected with the suction tube, the two or more electrodes A and B are fixed on the periphery of the suction cavity to construct a combined material that integrates urine sensing, drainage and collection.

[0030] Preferably, electrodes A and B or more electrodes are constructed into an external structure having a shape and size consistent with the periphery of the suction chamber, such as a sleeve, a C-shaped clip, or an O-ring structure, which can conveniently fix electrodes A and B or more electrodes on the periphery of the suction chamber.

[0031] In one embodiment, the capacitive urine trigger device is prepared as a plug-and-play independent component for use with a negative pressure pump or a negative pressure drainage device. Two electrodes A and B or multiple electrodes are 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 trigger device has the beneficial effect of proposing a urine trigger device with fast response speed, high urine recognition sensitivity and extremely low preparation cost. The negative pressure suction closed-loop feedback control circuit composed of the urine trigger device, the control mainboard and the negative pressure pump senses the patient's start of urination or end of urination according to the current parameter or capacitance change when the urine trigger device is turned on or off by urine, and feedback controls the working state of the vacuum pump control. 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 dormant state. Compared with the technical methods of sensing urine using liquid level sensors, temperature sensors, humidity sensors, etc., this technical solution not only has lower cost of nursing consumables and high inclusiveness, but also has high sensitivity in urination status monitoring, extremely low probability of distortion or false triggering, fast negative pressure start response time, and avoids urine overflow caused by delayed urine perception after urination or delayed negative pressure start. This technical solution fills the gap in this field and has great promotion value. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 A schematic diagram of a female urinary catheter with a capacitive urine trigger device Figure 2 A schematic diagram of an embodiment of a male urinary catheter equipped with an electrode-type urine trigger device Figure 3 This is a working principle diagram of a closed-loop feedback circuit composed of an electrode-type urine trigger device, a control mainboard, and a negative pressure pump. Figure 4 The working principle diagram of a closed-loop feedback circuit composed of a capacitive urine trigger device, a control mainboard, and a negative pressure pump is shown in the following example. Figure 5 Schematic diagram of an embodiment of a capacitive urine trigger device using four electrodes arranged on four opposite sides Figure 6 Schematic diagram of an in-line electrode urine trigger device using four electrodes As shown in the figure: anti-leakage shell (1), adsorption material (2), suction chamber (3), suction tube (4), A electrode (5), B electrode (6), extension wire (7), extension wire quick connector (8), C electrode (9), D electrode (10), electrode fixing base (11) DETAILED DESCRIPTION

[0034] The present invention is specifically described below in conjunction with the accompanying drawings and embodiments.

[0035] Example 1: Preparation of a female urinary catheter with a capacitive urine trigger device having a detachable and replaceable adsorbent material (2) 1. Material Preparation 1.1 As Figure 1 As shown, a plastic injection mold for a leak-proof shell (1) is designed and developed, and the applicable material is medical silicone rubber. The overall shape of the leak-proof shell is a banana shape or a stick shape, and the suction chamber (3) is arranged at a downstream position of the leak-proof shell (1). In order to improve the integration of components and reduce the assembly process, the suction chamber (3) and the leak-proof shell (1) are integrally formed.

[0036] 1.2 Design and develop an extrusion die for a double-lumen suction tube (4), using medical soft polyvinyl chloride (PVC) as the applicable material. The double-lumen suction tube (4) has an outer diameter of 9 mm, the main lumen is the suction lumen (3), and the inner diameter is 6 mm; the secondary lumen is used for wiring the extension wire (7), and the inner diameter is 1.5 mm; it is produced by extrusion technology and cut into sections of 300 mm each.

[0037] 1.3 The adsorbent material (2) is made of polyurethane sponge and is cut by die stamping according to the internal shape and space size of the anti-leakage shell (1). The adsorbent material (2) is required to be able to fit inside the anti-leakage shell (1) and not to fall out naturally.

[0038] 1.4 The A electrode (5) and the B electrode (6) are made of a copper sheet material with a thickness of 0.1 mm, cut into sheets with a length of 8 mm and a width of 5 mm.

[0039] 1.5 The extension wire (7) is made of 2-core copper wire, the outer diameter of the extension wire (7) is 1.2 mm, and it is cut into segments with a length of 500 mm.

[0040] 2. Assembly 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 the welding is completed, the A electrode (5), the B electrode (6) and the head of the extension wire (7) are sealed in a PVC film using a PVC heat sealing process. It is required that after the sealing, the A electrode (5), the B electrode (6) and the head of the extension wire (7) are in an insulated state.

[0041] 2.2 Using a guide wire, pass the tail of the extension wire (7) through the secondary cavity of the suction tube (4), so that the extension wire (7) penetrates 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). Using electronic welding and hot forming technology, a DC connector is assembled at the tail of the extension wire (7).

[0042] 2.3 Use medical cyclohexanone glue to bond the A electrode (5) and the B electrode (6) to the outer periphery of the head of the suction tube (4), respectively, and the A electrode (5) and the B electrode (6) are required to be arranged in a positive and opposite manner. After bonding is completed, gently pull the extension wire (7) to put all the excess extension wire (7) at the head of the suction tube (4) into the secondary cavity of the suction tube (4).

[0043] 2.4 As Figure 1 As shown, the suction tube (4) that has completed the above process is installed in the anti-leakage shell (1), requiring that the head of the suction tube (4) enters the interior of the suction cavity (3) and the tail of the suction tube (4) extends to the periphery of the anti-leakage shell (1).

[0044] 2.5 The adsorption material (2) is installed in the inner cavity of the anti-leakage shell (1), and the adsorption material (2) is required to be difficult to fall out naturally.

[0045] 2.6 Packaging and disinfection, qualified products can be put into storage.

[0046] 3. Instructions for use 3.1 Connect the tail of the suction tube (4) to the drainage pipeline and the negative pressure drainage bottle, and connect the DC connector at the tail of the extension wire (7) to the control mainboard of the negative pressure pump. After turning on the machine, you can perform fast-response feedback-type negative pressure drainage control catheterization.

[0047] 3.2 It is recommended that the adsorbent material (2) be replaced or cleaned every day. When replacement or cleaning is required, the adsorbent material (2) is removed from the anti-leakage shell (1) and a new or cleaned adsorbent material (2) is inserted.

[0048] Example 2 Preparation of a male urinary catheter with an electrode-type urine triggering device 1. Material preparation: 1.1 As Figure 2 As shown, a plastic injection mold for a leakproof housing (1) is designed and developed, and the applicable material is medical silicone rubber. The overall shape of the leakproof housing is a rod, and the suction chamber (3) is arranged at the downstream position of the leakproof housing (1), and the suction chamber (3) is provided with a suction tube (4) interface.

[0049] 1.2 Design and develop an extrusion die for a double-lumen suction tube (4), using medical soft polyvinyl chloride (PVC) as the applicable material. The double-lumen suction tube (4) has an outer diameter of 9 mm, the main lumen is the suction lumen (3), and the inner diameter is 6 mm; the secondary lumen is used for wiring the extension wire (7), and the inner diameter is 1.5 mm; it is produced by extrusion technology and cut into sections of 300 mm each.

[0050] 1.3 The adsorption material (2) is made of absorbent cotton and is prepared into a cylindrical structure with a height of 30 mm and a diameter of 35 mm-40 mm. The adsorption material (2) is required to be able to fit inside the anti-leakage shell (1) and not to fall out naturally.

[0051] 1.4 A copper wire with an outer diameter of 1.5 mm is cut into small sections with a length of 6 mm to serve as the A electrode (5) and the B electrode (6).

[0052] 1.5 The extension wire (7) is made of 2-core copper wire, the outer diameter of the extension wire (7) is 1.2 mm, and it is cut into segments with a length of 500 mm.

[0053] 2. Assembly 2.1 Weld the two cores at the head of the extension wire (7) to the tail of the A electrode (5) and the B electrode (6) respectively. After welding, separate the tail of the A electrode (5) and the B electrode (6) with silicone rubber, with a separation interval of 2-5 mm. The heads of the A electrode (5) and the B electrode (6) are exposed, and the welding points between the tail of the A electrode (5) and the B electrode (6) and the head of the extension wire (7) are insulated.

[0054] 2.2 Using a guide wire, pass the tail of the extension wire (7) through the secondary cavity of the suction tube (4), so that the extension wire (7) penetrates 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). Using electronic welding and hot forming technology, a DC connector is assembled at the tail of the extension wire (7).

[0055] 2.3 Use medical glue to bond the A electrode (5) and the B electrode (6) to the outer periphery of the head of the suction tube (4). After bonding, gently pull the extension wire (7) to put all the excess extension wire (7) at the head of the suction tube (4) into the secondary cavity of the suction tube (4).

[0056] 2.4 Use medical glue to install the head assembly of the suction tube (4) to the bottom of the anti-leakage shell (1), requiring that the head of the suction tube (4) is connected to the inside of the suction chamber (3), and the A electrode (5) and the B electrode (6) are completely wrapped in the bottom of the suction chamber (3).

[0057] 2.5 The adsorption material (2) is installed in the inner cavity of the anti-leakage shell (1), and the adsorption material (2) is required to be difficult to fall out naturally.

[0058] 2.6 Packaging and disinfection, qualified products can be put into storage.

[0059] Example 3 A capacitive urine triggering device using four electrodes arranged on four opposite sides 1. If Figure 5 As shown, an injection mold for developing and manufacturing an electrode fixing base (11) is developed. The electrode fixing base (11) is a perfect circle with an inner diameter of 6 mm, a wall thickness of 1 mm, and a height of 2.0 mm.

[0060] 2. Use 0.2mm thick copper sheet to make electrode sheets, cut them into rectangular pieces with a length of 6mm and a width of 2mm for later use.

[0061] 3. The four electrode sheets and the electrode fixing base (11) are injection molded into one piece by using a metal inlay injection molding process. The A electrode (5) and the B electrode (6) are arranged in a left-right column, and the C electrode (9) and the D electrode (10) are arranged in an upper-lower column. The lateral spacing between two adjacent electrodes is not less than 2 mm. The tail of each electrode is exposed 0.5 mm from the electrode fixing base (11).

[0062] 4. Use a four-core extension wire (7) and weld the tail of the electrode (exposing the electrode fixing base (11)) to the head of one of the cores of the extension wire (7) using an electronic welding process, with no cold solder joints or burrs on the solder joints.

[0063] 5. Use insulating paint to spray the welding points of the four electrode sheets and the extension wire (7) with insulation, and it is required that there is no leakage current at the welding points of each electrode and the extension wire (7).

[0064] 6. An extension wire (7) quick connector is assembled and packaged at the tail of the extension wire (7), and the quick connector adopts a USB connector.

[0065] The above drawings and embodiments are only used to illustrate the technical solution 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 and explain different electrodes, and the upper, lower, left, and right are only used to distinguish and explain different positions, rather than being limited by name. Although the present invention has been described in detail with reference to the preferred embodiments, it should be understood by those skilled in the art that the technical solution of the present invention can be modified or replaced by equivalents without departing from the purpose and scope of the technical solution of the present invention, which should be included in the scope of the claims of the present invention and does not constitute any limitation on the scope of protection of the present invention.

Claims

1. An external urinary catheter with a urine trigger device, mainly comprising an anti-leakage shell (1), an adsorbent material (2), a suction chamber (3), a suction tube (4) and a urine trigger device, wherein the anti-leakage shell (1) is a waterproof isolation device that is convenient for a patient to wear or fix on the periphery of a urethral opening to prevent urine from leaking to the periphery, the adsorbent material (2) is arranged inside the anti-leakage shell (1), the suction chamber (3) is arranged at a downstream position of the anti-leakage shell (1), and the head end of the suction tube (4) is combined with the inside of the suction chamber (3), characterized in that: At least one side of the anti-leakage housing (1) is provided with a urination window combined with the urethral opening, and the urine triggering device comprises at least two electrodes A and B and an extension wire (7); according to different ways in which the urine triggering device senses liquid, the urine triggering device comprises an electrode-type urine triggering device and a capacitive-type urine triggering device; The negative pressure suction closed-loop feedback control circuit composed of the urine trigger device, the control main board and the vacuum pump senses the patient's start of urination or the end of urination according to the current parameters or capacitance changes when the urine trigger device is turned on or off by urine, and feedback controls the working state of the vacuum pump control; when the urine trigger device is turned on by urine, the negative pressure pump responds quickly and starts negative pressure suction, and when urination ends, the urine trigger device is automatically disconnected, and the negative pressure pump returns to standby or dormant state.

2. The external urinary catheter with a urine triggering device according to claim 1, characterized in that: The adsorption material (2) is arranged inside the anti-leakage shell (1), and the adsorption material (2) is embedded in the inner cavity of the anti-leakage shell (1) and the urethra opening. The adsorption material (2) can be quickly taken out 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) in contact with the urethral opening is a hydrophobic isolation layer, the inner layer is a water-absorbing layer, and the adsorbent material (2) is provided with a urine diversion hole or a diversion groove 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 catheter, a triple-lumen catheter or a double-row catheter. The main lumen of the suction tube (4) is used for urine drainage, and the extension wire (7) is arranged through other secondary lumens.

5. The 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 arranged inside the anti-leakage housing (1), and the electrodes should be arranged at a location where urine must flow through, and the extension wire (7) extends to the periphery of the anti-leakage housing (1).

6. The 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 periphery of the electrodes is encapsulated by an insulating plate. The electrodes of the capacitive urine triggering device are arranged in the cavity or the periphery of the cavity through which urine flows.

7. The external urinary catheter with a urine triggering device according to claim 1, characterized in that: A drainage catheter, a negative pressure drainage bottle and other components may also be combined downstream thereof, and the suction tube (4) is connected to the drainage catheter and the negative pressure drainage bottle to form a complete combined material integrating urine sensing, drainage and collection; wherein, in addition to the above-mentioned arrangement of the urine trigger device, the urine trigger device may also be arranged on the drainage catheter or the negative pressure drainage bottle.

8. The external urinary catheter with a urine triggering device according to claim 1, characterized in that: The capacitive urine trigger device is prepared as a plug-and-play independent component used in conjunction with a negative pressure pump or a negative pressure drainage device, and two electrodes A and B or multiple electrodes are fixed on the periphery of the suction cavity (3) to construct a urine sensing and negative pressure drainage system.

9. The working principle of using an electrode-type urine trigger device to feedback control the operation of the negative pressure pump is to use at least two electrodes A / B. The electrode-type urine trigger device, the control main board and the vacuum pump form a closed-loop feedback control circuit, and the operation and stop of the vacuum pump are controlled by the core processor; during the patient's extracorporeal 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 the A or B electrode jumps to the control threshold, it is judged that the patient is excreting urine, and the core processor immediately instructs the negative pressure pump to perform suction work; when the current parameter of the A or B electrode returns to the initial value, it is judged that the patient has finished urinating, the negative pressure pump stops working or delays stopping working, and the negative pressure pump returns to standby or sleep state.

10. The working principle of the negative pressure pump operation controlled by the capacitive urine trigger device is that the two electrodes A and B construct a stable electric field in the cavity or the periphery of the cavity through which urine flows, and the extension wire (7) is connected to the control mainboard of the negative pressure pump and communicates with it, so that the capacitive urine trigger device, the control mainboard and the negative pressure pump form a closed-loop feedback control circuit, and 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 is judged that the patient has discharged 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 with a delay, and the negative pressure pump returns to the standby or dormant state.

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