Negative plate

Abstract

The invention provides a negative plate, which comprises a bonding layer, a conductive layer and a wire, and is characterized in that a temperature sensing layer is arranged between the bonding layer and the conductive layer; the temperature sensing layer comprises a flexible substrate layer, an electrode layer, a temperature sensitive layer and a protective layer; the flexible substrate layer is a PET (Polyethylene Terephthalate) film; the electrode layer is an interdigital electrode formed on the flexible substrate layer; the temperature sensitive layer is a thermistor layer formed on the electrode layer; the protective layer is a PE film fixed on the temperature sensitive layer; the electrode layer is connected with a signal processing module through a wire, and the signal processing module is connected with a host of the high-frequency electrotome system. According to the negative plate provided by the embodiment of the invention, skin scald of a patient caused by local overheating of the negative plate can be prevented in time through temperature monitoring.

Description

Technical Field

[0001] This application belongs to the technical field of medical devices, and particularly relates to a negative electrode plate. Background Art

[0002] The negative electrode plate for high-frequency surgery, also known as the neutral electrode, dispersive electrode, circuit electrode, circuit pad, or muscle application plate, etc., is an essential consumable in modern electro-surgical operations. The main function of the negative electrode plate is to provide a complete and safe current loop for the high-frequency electrosurgical system. During the operation, the high-frequency current passes through the human tissue, and the ablation electrode generates heat energy at the target tissue to achieve functions such as cutting and coagulation, while the negative electrode plate ensures the safe outflow of the current from the body and guarantees the smooth progress of the operation. At the same time, the use of the negative electrode plate can also effectively reduce the current density, increase heat dissipation, disperse the current, and prevent thermal damage.

[0003] The negative electrode plate is generally divided into two types: monopolar and bipolar, also called single-piece type and double-piece type. The monopolar negative electrode plate is more common. When the bipolar negative electrode plate is used in an electrosurgical unit with a function of detecting the impedance of the electrode plate, it will assist the electrosurgical unit host to continuously detect the pasting quality. The bipolar negative electrode plate divides the conductive aluminum film into two parts. The design purpose is to detect the contact effect between the negative electrode plate and the patient. After the negative electrode plate is pasted on the skin, the loop detection system RAM in the electrosurgical unit will check the quality of the contact area. If the contact area is insufficient (the resistance is too large, greater than 135 Ω), or there is a short-circuit phenomenon (the resistance is less than 5 Ω), the electrosurgical unit will give an audible and visual alarm and stop the output at the same time.

[0004] However, the bipolar negative electrode plate only detects the contact effect between the negative electrode plate and the patient through resistance, and cannot prevent skin burns caused by local overheating of the negative electrode plate in a timely manner through temperature monitoring. Summary of the Invention

[0005] An embodiment of this application provides a negative electrode plate, which includes an adhesive layer, a conductive layer, and a wire. A temperature sensing layer is provided between the adhesive layer and the conductive layer; The temperature sensing layer includes a flexible base layer, an electrode layer, a temperature sensitive layer, and a protective layer; The flexible base layer is a PET film; The electrode layer is an interdigital electrode formed on the flexible base layer; The temperature sensitive layer is a thermistor layer formed on the electrode layer; The protective layer is a PE film fixed on the temperature sensitive layer; The electrode layer is connected to a signal processing module through a wire, and the signal processing module is connected to the host of the high-frequency electrosurgical system.

[0006] In one possible implementation, for the negative electrode plate provided in the embodiments of the present application, the formation of the interdigital electrode includes: printing carbon-based conductive ink with a thickness of 10 μm and an interdigital screen pattern on the flexible substrate layer by a screen printing machine, and drying it at 80°C for 10 minutes to cure the ink, thereby forming the interdigital electrode.

[0007] In one possible implementation, for the negative electrode plate provided in the embodiments of the present application, the formation of the thermistor layer includes: uniformly coating NTC paste on the interdigital electrode by a slot coater with a coating thickness of 20 μm, and curing it at 100°C for 15 minutes to form the thermistor layer.

[0008] In one possible implementation, for the negative electrode plate provided in the embodiments of the present application, the fixing of the PE film includes: covering the PE film on the temperature-sensitive layer and thermally pressing it for 30 seconds under the conditions of a temperature of 120°C and a pressure of 0.5 Mpa by a hot press.

[0009] In one possible implementation, for the negative electrode plate provided in the embodiments of the present application, the adhesive layer is an antibacterial hydrogel layer.

[0010] In one possible implementation, for the negative electrode plate provided in the embodiments of the present application, 0.5 - 1% of Ag nanoparticles based on the total mass of the antibacterial hydrogel layer are added to the antibacterial hydrogel layer.

[0011] In one possible implementation, for the negative electrode plate provided in the embodiments of the present application, micro air holes with a density of 500 - 1000 pieces / cm² are formed on the antibacterial hydrogel layer, and the pore diameter of the micro air holes is 50 - 100 μm.

[0012] In one possible implementation, for the negative electrode plate provided in the embodiments of the present application, the antibacterial hydrogel layer contains a temperature-sensitive color-changing material, and the temperature-sensitive color-changing material changes color when the temperature ≥ 45°C.

[0013] In one possible implementation, for the negative electrode plate provided in the embodiments of the present application, the temperature-sensitive color-changing material includes cobalt blue powder.

[0014] Beneficial effects: For the negative electrode plate provided in the embodiment of the present application, the resistance value of the thermistor layer changes with the change of the patient's skin temperature. The electrode layer senses the change of the resistance signal by contacting the thermistor layer, and transmits the change of the resistance signal to the signal processing module through a wire. The signal processing module calculates the patient's skin temperature according to the resistance signal. If the temperature is about to be higher than the human skin tolerance temperature, a signal is sent to the host of the high-frequency electrosurgical unit system to make the host of the high-frequency electrosurgical unit system alarm and remind the operator. If the temperature rises rapidly and is much higher than the human skin tolerance temperature, the host of the high-frequency electrosurgical unit system controls the electrosurgical unit to cut off the power, so as to prevent the patient's skin from being scalded due to local overheating of the negative electrode plate in time through temperature monitoring.

[0015] In addition, the temperature-sensitive color-changing material contained in the antibacterial hydrogel layer can change color when the temperature ≥ 45°C, so that the operator can be reminded to pay attention to the patient's skin temperature situation in time through the color change, and the patient's skin scald can be further avoided. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, the drawings in the following description are some embodiments of the present application. For those of ordinary skill in the art, other drawings can be obtained according to these drawings without creative efforts.

[0017] Figure 1 is a schematic structural diagram of the negative electrode plate provided in the embodiment of the present application; Figure 2 is a schematic diagram of each layer of the temperature sensing layer in the negative electrode plate provided in the embodiment of the present application; 10 - Adhesive layer; 20 - Conductive layer; 30 - Temperature sensing layer; 31 - Flexible base layer; 32 - Electrode layer; 33 - Temperature-sensitive layer; 34 - Protective layer; 40 - Wire; 50 - Signal processing module. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0018] To make the objectives, technical solutions, and advantages of this application more clear, the following will describe in more detail the technical solutions in the embodiments of this application with reference to the accompanying drawings in the preferred embodiments of this application. In the drawings, the same or similar reference numerals represent the same or similar components or components with the same or similar functions from beginning to end. The described embodiments are some but not all of the embodiments of this application. The embodiments described below by referring to the accompanying drawings are exemplary and are intended to explain this application and should not be construed as a limitation to this application. Based on the embodiments in this application, all other embodiments obtained by those of ordinary skill in the art without creative efforts belong to the scope of protection of this application.

[0019] Participate Figures 1 to 2 As shown, the embodiment of this application provides a negative electrode plate, which includes an adhesive layer 10, a conductive layer 20, and a wire 40. A temperature sensing layer 30 is provided between the adhesive layer 10 and the conductive layer 20. The temperature sensing layer 30 includes a flexible base layer 31, an electrode layer 32, a temperature sensitive layer 33, and a protective layer 34, where: The material of the flexible base layer 31 is selected as a medical-grade PET (polyethylene terephthalate) film. The medical-grade PET has low cost, good flexibility, and meets the biocompatibility standard (complies with ISO 10993). The thickness of the base layer is 50 - 80 μm to ensure a balance between flexibility and durability.

[0020] The electrode layer 32 is an interdigital electrode structure printed on the flexible base layer 31 by a screen printing machine. The material of the electrode layer 32 is selected as carbon-based conductive ink. The line width of the interdigital electrode is 0.5 mm, and the spacing is 0.3 mm.

[0021] The formation of the interdigital electrode includes: printing carbon-based conductive ink with a thickness of 10 μm and a screen pattern in the shape of interdigital fingers on the flexible base layer 31 by a screen printing machine, and drying it at 80°C for 10 minutes to cure the ink to form the interdigital electrode.

[0022] The electrode layer 32 is connected to a signal processing module 50 through a wire 40, and the signal processing module 50 is connected to the host of the high-frequency electrotome system.

[0023] The temperature sensitive layer 33 is a thermistor layer formed by coating and curing on the electrode layer 32 by a slot coater. The material of the temperature sensitive layer 33 is selected as NTC paste, and the coating area is slightly smaller than the electrode area.

[0024] The formation of the thermistor layer includes: uniformly coating NTC paste on the interdigital electrode by a slot coater, with a coating thickness of 20 μm, and curing it at 100°C for 15 minutes to form the thermistor layer.

[0025] Thermistor layer characteristics: The resistance value is approximately 10 kΩ at 25°C, and the temperature coefficient (B value) ≈ 3500 K (in the temperature range of 25 - 50°C), meeting the accuracy requirement of ±0.2°C.

[0026] NTC (Negative Temperature Coefficient) material is a thermosensitive material whose resistance value decreases as the temperature increases. Its core characteristics are determined by the semiconductor properties of transition metal oxides (such as oxides of manganese, cobalt, nickel, iron, etc.). NTC materials achieve temperature measurement through their resistance-temperature characteristics.

[0027] The NTC paste can be prepared by mixing manganese-cobalt-nickel oxide (Mn-Co-Ni-O) nanoparticles and polyurethane (PU) binder in a mass ratio of 6:4, adding NMP or N-methylpyrrolidone to adjust the viscosity, ultrasonic dispersing for 1 hour, and then further refining the particles using a three-roll grinder.

[0028] Commercially available pre-synthesized NTC paste can also be used.

[0029] The protective layer 34 is a PE film formed by hot pressing and curing on the thermistor layer. The fixation of the PE film includes: covering the PE film on the temperature-sensitive layer 33 and hot pressing for 30 seconds at a temperature of 120°C and a pressure of 0.5 Mpa using a hot press.

[0030] The adhesive layer 10 is an antibacterial hydrogel layer. Ag nanoparticles are added to the antibacterial hydrogel layer and micron-sized breathable pores are formed. The antibacterial hydrogel layer contains a temperature-sensitive color-changing material that changes color when the temperature ≥ 45°C.

[0031] The addition amount of Ag nanoparticles is 0.5 - 1% of the total mass of the antibacterial hydrogel layer. The density of the micron-sized breathable pores is 500 - 1000 pores / cm², and the pore diameter of the micron-sized breathable pores is 50 - 100 μm. Bacteriostasis is achieved through Ag nanoparticles, and the micron-sized breathable pores form a sweat drainage channel to avoid sweat accumulation.

[0032] The temperature-sensitive color-changing material is cobalt blue (CoCl 2 ·6H 2 O). In a high-temperature environment (>45°C), cobalt blue loses its crystal water and turns pink, and returns to blue at low temperature.

[0033] The usage process of the above negative electrode plate: Confirm that the electrosurgical device is in the off state, and check whether the negative electrode plate is intact without cracks, scratches or contamination on the surface.

[0034] Clean the patient's skin, remove grease, sweat, hair, etc., and ensure the skin is dry and clean. Select a flat and muscular area (such as the thigh, buttock or back) to paste the negative electrode plate, and avoid areas with bone protrusions, scars or fat accumulation.

[0035] Firmly paste the negative electrode plate on the patient's skin to ensure there are no air bubbles or wrinkles. Connect the negative electrode plate to the main unit of the high-frequency electrosurgical system to ensure that the conductive layer 20 and the signal processing module 50 are connected to the main unit. Confirm that the connection is stable and there is no looseness.

[0036] During use, the change in the patient's skin temperature will change the resistance value of the thermistor layer. The electrode layer 32 senses the change in the resistance signal by contacting the thermistor layer, and transmits the change in the resistance signal to the signal processing module 50 through the wire 40. The signal processing module 50 calculates the patient's skin temperature based on the resistance signal. If the temperature is about to be higher than the human skin tolerance temperature, it will send a signal to the main unit of the high-frequency electrosurgical system to make the main unit of the high-frequency electrosurgical system alarm and remind the operator. If the temperature rises rapidly and is much higher than the human skin tolerance temperature, the main unit of the high-frequency electrosurgical system will control the electrosurgical knife to cut off the power to avoid scalding the patient's skin.

[0037] In addition, the temperature-sensitive color-changing material contained in the antibacterial hydrogel layer can change color when the temperature ≥ 45°C, so as to remind the operator to pay attention to the patient's skin temperature situation in time through the color change, and further avoid scalding the patient's skin.

[0038] In the description of the embodiments of the present application, it should be understood that unless otherwise clearly specified and limited, the terms "installation", "connection", and "connection" should be understood in a broad sense. For example, it can be a fixed connection, or an indirect connection through an intermediate medium. It can be the communication inside two components or the interaction relationship between two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present application can be understood according to specific situations. The orientation or positional relationship indicated by the terms "upper", "lower", "front", "rear", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or component referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation to the present application. In the description of the present application, "a plurality of" means two or more unless otherwise specifically specified.

[0039] The terms "first", "second", "third", "fourth", etc. in the description, claims and above-mentioned drawings of this application are used to distinguish similar objects and do not necessarily describe a specific order or sequence. It should be understood that the data used in this way can be interchanged under appropriate circumstances so as to implement the embodiments of this application described here. For example, it can be implemented in an order other than those illustrated or described here. In addition, the terms "comprising" and "having" and any variations thereof are intended to cover non-exclusive inclusion. For example, a process, method, system, product or device comprising a series of steps or units does not necessarily limit to those steps or units clearly listed, but may include other steps or units not clearly listed or inherent to these processes, methods, products or devices.

[0040] Finally, it should be noted that: the above embodiments are only used to illustrate the technical solutions of this application and are not intended to limit them; although this application has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: they can still modify the technical solutions recorded in the foregoing embodiments, or perform equivalent replacements on some or all of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of this application.

Claims

1. A negative electrode plate, comprising an adhesive layer, a conductive layer and a lead, characterized in that: A temperature sensing layer is provided between the adhesive layer and the conductive layer; The temperature sensing layer includes a flexible substrate layer, an electrode layer, a temperature sensitive layer and a protective layer; The flexible substrate layer is a PET film; The electrode layer is an interdigitated electrode formed on a flexible substrate layer; The temperature sensitive layer is a thermistor layer formed on the electrode layer; The protective layer is a PE film fixed on the temperature sensitive layer; The electrode layer is connected to a signal processing module via a wire, and the signal processing module is connected to a host of a high-frequency electrosurgical unit system.

2. The negative electrode plate according to claim 1, characterized in that: The formation of the interdigitated electrodes includes: printing a carbon-based conductive ink with a thickness of 10 μm and an interdigitated screen pattern on the flexible substrate by a screen printer, and drying the ink at 80° C. for 10 minutes to solidify the ink to form the interdigitated electrodes.

3. The negative electrode plate according to claim 1, characterized in that: The formation of the thermistor layer includes: uniformly coating the NTC slurry on the interdigital electrodes by a slit coater with a coating thickness of 20 μm, and curing at 100° C. for 15 minutes to form the thermistor layer.

4. The negative electrode plate according to claim 1, characterized in that: The fixing of the PE film comprises: covering the PE film on the temperature sensitive layer and hot pressing the PE film for 30 seconds at a temperature of 120° C. and a pressure of 0.5 MPa using a hot press.

5. The negative electrode plate according to any one of claims 1 to 5, characterized in that: The adhesive layer is an antibacterial hydrogel layer.

6. The negative electrode plate according to claim 5, characterized in that: The antibacterial hydrogel layer is added with Ag nanoparticles accounting for 0.5-1% of the total mass of the antibacterial hydrogel layer.

7. The negative electrode plate according to claim 5, characterized in that: The antibacterial hydrogel layer is formed with micron air pores with a density of 500-1000 / cm², and the pore size of the micron air pores is 50-100 μm.

8. The negative electrode plate according to claim 5, characterized in that: The antibacterial hydrogel layer comprises a temperature-sensitive color-changing material, and the temperature-sensitive color-changing material changes color when the temperature is ≥45°C.

9. The negative electrode plate according to claim 8, characterized in that: The temperature-sensitive color-changing material includes cobalt blue powder.

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