Medical plug-in EIT disposable electrode array and collector

Abstract

The utility model belongs to the technical field of medical electrical impedance tomography in biomedical engineering, and particularly relates to a medical plug-in EIT disposable electrode array and a collector. The electrode array comprises a plurality of electrode plates, a medical non-woven fabric, conductive hydrogel layers, a release film, a flat cable and a male terminal, the plurality of electrode plates are uniformly embedded on the medical non-woven fabric at intervals, the conductive hydrogel layer is arranged on the bottom surface of each electrode plate, the release film is arranged on the bottom surface of the medical non-woven fabric to protect the conductive hydrogel layer, and the male terminal is arranged on the conductive hydrogel layer. The plurality of electrode plates are connected with one end of the flat cable, the other end of the flat cable is connected with the male terminal, and the male terminal is connected with the female terminal of the lead wire. According to the medical EIT electrode system, the comprehensive performance of the medical EIT electrode system is remarkably improved through a modularized four-electrode integrated design, a multilayer shielding lead wire and a standardized interface scheme.

Description

Technical Field

[0001] The utility model belongs to the technical field of medical electrical impedance imaging in biomedical engineering, and particularly relates to a medical plug-in EIT disposable electrode array and a collector. Background Art

[0002] Existing medical electrical impedance tomography (EIT) electrode systems generally use fixed metal snap-on lead wires, which present the following clinical pain points:

[0003] Low operational efficiency: Traditional electrode strips require manual snapping of ECG lead interfaces one by one, and a single operation takes 3-5 minutes, which can easily delay diagnosis in emergency scenarios.

[0004] Risks of reuse: Silver / silver chloride electrodes rely on ethylene oxide for disinfection and reuse. After 5 sterilizations, the impedance of the conductive gel increases by more than 40%, and there is a risk of cross-infection, which does not meet the requirements of sterile environments such as ICUs.

[0005] Hidden danger of mechanical damage: The rigid snap button structure generates a local pressure greater than 25kPa when wrapped around the chest, resulting in a skin indentation rate as high as 12% in newborns and burn patients.

[0006] Adaptability defects: Fixed-pitch electrode arrays cannot adapt to differences in chest circumference, resulting in electrode slippage in 30% of obese patients.

[0007] CN222149998U discloses an integrated injection-molded electrode belt for EIT equipment, in which the electrode sheet and the conductive component are connected through a conductive plate, which is arranged on the baseband and connected to the electrode sheet, and all the conductive plates are connected through a conductive cable. Integrating the conductive cable and the conductive plate in the baseband requires a complex injection molding process and precise mold design. The production process requires multiple injection molding and welding steps, which increases the complexity of production. The electrode belt needs to be wrapped around the human body and fixed, which is a cumbersome operation. The conductive cable is integrated in the baseband and may be affected by external electromagnetic interference, affecting the stability of signal transmission. The electrode sheet is in direct contact with the skin, and there may be a problem of large contact resistance, which affects the accuracy of signal acquisition. Utility Model Content

[0008] The utility model provides a medical plug-in four-channel EIT disposable electrode array and collector, which significantly improves the comprehensive performance of the medical EIT electrode system through a modular four-electrode integrated design, an error-proof guide head, a multi-layer shielded lead wire and a standardized interface solution.

[0009] The technical solution of the utility model is as follows:

[0010] The first aspect of the present invention is to provide a medical pluggable EIT disposable electrode array, comprising:

[0011] Multiple electrode sheets, serving as conductive components for signal collection;

[0012] Medical non-woven fabric, with multiple electrodes evenly spaced and embedded on the medical non-woven fabric;

[0013] A conductive hydrogel layer is provided on the bottom surface of each electrode sheet for good contact with the skin;

[0014] The release film is provided on the bottom surface of the medical non-woven fabric to protect the conductive hydrogel layer and is removed during use to allow the conductive hydrogel layer to adhere to the skin;

[0015] A cable with multiple electrode pads connected at one end and male terminals at the other end;

[0016] Male terminal, connected to the female terminal of the lead wire.

[0017] Furthermore, it also includes an electrode protection patch covering the top surface of each electrode sheet.

[0018] Furthermore, it also includes an electrode reinforcement layer, which is pasted on the top surface of the medical non-woven fabric.

[0019] Furthermore, the electrode reinforcement layer is a long strip of label paper, and a through hole is formed on the long strip of label paper at a position corresponding to each electrode sheet.

[0020] Furthermore, the male terminal has a built-in guide groove to prevent mis-insertion.

[0021] The second aspect of the present invention provides a medical pluggable EIT collector, comprising the medical pluggable EIT disposable electrode array and lead wires.

[0022] Furthermore, the lead wire includes a shielded wire, two female terminals and a plug. The shielded wire has a three-layer structure, with an inner layer of a silver-plated copper core wire, a middle layer of an aluminum foil shielding layer, and an outer layer of a conductive silicone sheath.

[0023] Furthermore, the leads of the two female terminals are connected to the shielded wire after being combined by a wire combiner. A plug is integrated at the tail of the shielded wire, and the plug is connected to the EIT device host.

[0024] The technical solution of this utility model focuses on improving the modular quick connection, signal anti-interference ability and clinical adaptability of the electrode system in EIT equipment. It is particularly suitable for medical scenarios that require high-precision bioelectrical signal acquisition, such as dynamic lung impedance monitoring and abdominal organ function assessment.

[0025] Advantages and beneficial effects of the utility model:

[0026] 1. In terms of hygiene and safety, the disposable electrode array is combined with a medical non-woven fabric substrate, and the overall replacement design effectively reduces the risk of cross-infection, while simplifying clinical operation processes and significantly improving deployment efficiency.

[0027] 2. In terms of signal quality, the composite shielding structure of the lead wire combined with the optimized circuit design greatly suppresses external electromagnetic interference, ensures high-precision bioelectric signal acquisition, and significantly improves imaging resolution.

[0028] 3. In terms of structural reliability, the lead wire uses reinforced tensile material and high-voltage resistant design to adapt to complex clinical environments. At the same time, the flexible substrate and curved layout optimize the fit to the body surface curvature, adapt to the body shape differences between adults and children, and reduce the risk of electrode slippage. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 This is a structural diagram of the medical plug-in EIT disposable electrode array of the present utility model;

[0030] Figure 2 Schematic diagram of the cross section of the electrode array of the present invention;

[0031] Figure 3 This is a structural diagram of the collector of the utility model;

[0032] Figure 4 This is a structural diagram of the lead wire of the utility model;

[0033] In the figure: 1. Electrode sheet, 2. Electrode protection patch, 3. Conductive hydrogel layer, 4. Medical non-woven fabric, 5. Electrode reinforcement layer, 6. Release film, 7. Cable, 8. Male terminal, 9. Shielding wire, 10. Plug, 11. Female terminal. DETAILED DESCRIPTION

[0034] The present invention will be further described in detail below through specific embodiments. The following embodiments are merely illustrative and non-restrictive, and should not be used to limit the scope of protection of the present invention.

[0035] like Figures 1 and 2 The illustrated medical plug-in EIT disposable electrode array comprises four electrode pads 1, a conductive hydrogel layer 3, a medical nonwoven fabric 4, a release film 6, a cable 7, and a male terminal 8. The four electrode pads 1 are evenly spaced and embedded on the medical nonwoven fabric 4. The conductive hydrogel layer 3 is disposed on the bottom surface of each electrode pad 1. A release film 6 is also disposed on the bottom surface of the medical nonwoven fabric 4 to protect the conductive hydrogel layer 3. The release film 6 is removed during use to allow the conductive hydrogel layer 3 to adhere to the skin. The multiple electrode pads 1 are connected to one end of a cable 7, the other end of which is connected to a male terminal 8.

[0036] The electrode sheet 1, conductive hydrogel layer 3, medical nonwoven fabric 4, and release film 6 are formed into an indivisible integrated unit through multiple processes, including lamination, dispensing, and curing. A low-impedance electrical connection is achieved between the electrode sheet 1 and the flat cable 7 through heat pressing. During use, the release film 6 is removed to expose the conductive hydrogel layer 3, allowing direct application to the target biological surface, achieving high-precision signal acquisition while ensuring the hygienic safety of single-use devices.

[0037] As a preferred embodiment, the electrode sheet 1 adopts a silver chloride electrode sheet, the cable 7 adopts a PVC four-core cable, the male terminal 8 adopts a 4PIN male terminal, has a built-in anti-misinsertion guide groove, has a plug-in life of ≥5000 times, and has enhanced tensile strength through a spiral metal braided layer (bending fatigue life is increased by 3 times).

[0038] The conductive hydrogel layer 3 has a viscosity of 5000 ± 500 cP, an impedance of ≤ 50 Ω·cm², and a release film 6 thickness of 50 μm. The conductive hydrogel has passed ISO 10993 biocompatibility certification.

[0039] Medical non-woven fabric 4 is white, with a curvature radius of ≥50mm and a thickness of 0.2mm. Its curved design adapts to the varying body curvatures of adults and children, and its replacement time is ≤10 seconds per set. In clinical trials, it demonstrated no shedding after ≥8 hours of continuous use.

[0040] The four independent electrodes of the electrode array are integrated with a white medical non-woven fabric substrate. The white PVC four-core cable is welded to the silver chloride snap-on base of each electrode. The ends are then connected to a cool gray ABS 4-pin bobbin and 1.0 gold-plated 5μ male terminals through high-precision welding. A double-molded process (the inner mold is made of transparent PP and the outer mold is made of 40P yellow non-toxic elastic PVC (color card number: 156C)) forms a disposable, replaceable unit. The cable 7 and male terminals 8 are recyclable and reusable. This modular design allows for seamless integration of electrodes and lead wires, combining mechanical stability, electrical performance consistency, and clinical ease of use, meeting the reliability and reusability requirements of medical devices.

[0041] In order to protect the electrode sheet 1 , an electrode protection patch 2 is also included, covering the top surface of each electrode sheet 1 .

[0042] In order to reinforce and support the electrode sheet 1, an electrode reinforcement layer 5 is also included and is pasted on the top surface of the medical non-woven fabric 4. The electrode reinforcement layer 5 is a long strip of label paper with through holes formed on the long strip of label paper corresponding to the position of each electrode sheet 1.

[0043] The utility model also provides a medical plug-in EIT collector, such as Figure 3 As shown, it includes a medical plug-in EIT disposable electrode array and lead wire.

[0044] like Figure 4 The lead wire shown includes a shielded wire 9, two female terminals 11 and a plug 10. The shielded wire 9 has a three-layer structure. The inner layer is a silver-plated copper core wire (conduction impedance <1Ω, wire diameter 0.1mm), the middle layer is an aluminum foil shielding layer (coverage ≥95%), which effectively suppresses high-frequency interference, and the outer layer is a conductive silicone sheath (cold-resistant -20℃ TPU material, thickness 0.5mm), with a bending radius of ≤3mm. The three-layer composite structure suppresses external electromagnetic interference.

[0045] Each shielded cable 9 is equipped with two female terminals (4-pin female terminal skeleton + spring buckle) at the head, and the two female terminals 11 are respectively connected to a group of four-channel electrode arrays to ensure quick plugging and unplugging without the risk of single-electrode operation; the tail of the shielded cable 9 is integrated with a 10-pin Reynolds head plug, of which 8 pins are used for four-channel signal transmission and 2 pins are dedicated to the shielded ground wire to reduce common-mode interference.

[0046] The EIT device host is equipped with two 10-pin Reynolds female connectors, which are connected to two shielded wires 9 to achieve seamless connection of the 16-channel electrode array without the need to expand new channels.

[0047] In a preferred embodiment, the shielded cable 9 comprises two 3.5 mm diameter, cool gray TPU four-core shielded cables. The ends are welded to a 4-pin female end bobbin snap clip and a 1.0×14 mm gold-plated male terminal, respectively. The weather-resistant female terminal is then formed by injection molding an inner mold (made of transparent PP) and an outer mold (made of 40P yellow, non-toxic, elastic PVC, color swatch number 156C) to form a composite. The other end is connected to a 4.0 mm diameter, cool gray TPU ten-core shielded cable via low-impedance welding. A multi-wire paralleling injection molded connector is then formed using an inner mold made of transparent PP and an outer mold made of -20°C cold-resistant 60P / PVC cool gray material. This connector is then welded to a 10-pin Reynolds connector, creating a low-impedance lead cable with electromagnetic shielding properties suitable for transmitting highly sensitive medical electrophysiological signals.

[0048] Assembly and use of this modular electrode array:

[0049] Step 1: Select the specifications of the preformed electrode array according to the patient's chest curvature radius, and use the flexible deformation properties of the non-woven fabric substrate to adaptively fit the body surface contour to ensure full contact coupling between the conductive hydrogel layer and the skin surface.

[0050] Step 2: After removing the release film 6, press the integrated electrode array onto the target area (e.g., the fourth intercostal space on the left side of the sternum). The microporous breathable structure of the non-woven fabric substrate (pore size 0.1 mm, pore density ≥ 200 pores / cm²) achieves an epidermal water vapor transmission rate ≥ 50 g / m²·24 h, supporting continuous monitoring for ≥ 8 hours without mechanical shedding.

[0051] Step 3: Align the female lead wire terminals 11 with the male terminals 8 of the electrode array for quick, tool-free connection (≤10 seconds per four electrodes). After connection, perform a continuity check. If an electrode becomes detached, an LED alarm is triggered, and the host computer simultaneously locks the abnormal channel data output.

[0052] Step 4: After monitoring, slowly peel the electrode array along the edge of the nonwoven fabric at an angle of ≤30° to avoid epidermal damage (peeling speed ≤5 cm / s). Dispose of the used electrodes as medical waste. The conductive hydrogel layer 3 degrades ≥90% within 72 hours after removal, complying with ISO 10993 biocompatibility standards. The cable 7 and male terminal 8 are recyclable, reducing costs.

[0053] The innovation of the present utility model focuses on the modular topological design of the electrode array. The conductive hydrogel and release film are existing technologies and are not within the scope of protection of the claims.

[0054] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this field, several modifications and improvements can be made without departing from the concept of the utility model, which all fall within the scope of protection of the present invention.

Claims

1. A medical plug-in EIT disposable electrode array, characterized in that: include: A plurality of electrode sheets (1) serving as conductive components for signal collection; A medical non-woven fabric (4), with a plurality of electrode sheets (1) evenly spaced and embedded on the medical non-woven fabric (4); A conductive hydrogel layer (3) is provided on the bottom surface of each electrode sheet (1) for good contact with the skin; A release film (6) is provided on the bottom surface of the medical non-woven fabric (4) to protect the conductive hydrogel layer (3) and is removed during use to allow the conductive hydrogel layer (3) to adhere to the skin; A cable (7), one end of which is connected to the plurality of electrode sheets (1) and the other end of which is connected to the male terminal (8); The male terminal (8) is connected to the female terminal (11) of the lead wire.

2. The medical pluggable EIT disposable electrode array according to claim 1, characterized in that: It also includes an electrode protection patch (2) covering the top surface of each electrode sheet (1).

3. The medical pluggable EIT disposable electrode array according to claim 2, characterized in that: It also includes an electrode reinforcement layer (5) adhered to the top surface of the medical non-woven fabric (4).

4. The medical pluggable EIT disposable electrode array according to claim 3, characterized in that: The electrode reinforcement layer (5) is a long strip of label paper, and a through hole is formed on the long strip of label paper at a position corresponding to each electrode sheet (1).

5. The medical pluggable EIT disposable electrode array according to claim 1, characterized in that: The male terminal (8) has a built-in guide groove to prevent mis-insertion.

6. A medical plug-in EIT collector, characterized in that: The invention comprises the medical pluggable EIT disposable electrode array and lead wire according to any one of claims 1 to 5.

7. The medical plug-in EIT collector according to claim 6, characterized in that: The lead wire comprises a shielding wire (9), two female terminals (11) and a plug (10); the shielding wire is a three-layer structure, with an inner layer being a silver-plated copper core wire, a middle layer being an aluminum foil shielding layer, and an outer layer being a conductive silicone sheath.

8. The medical plug-in EIT collector according to claim 7, characterized in that: The leads of the two female terminals (11) are connected to the shielded wire (9) after being combined by a wire combiner. A plug (10) is integrated at the tail of the shielded wire (9), and the plug (10) is connected to the EIT device host.

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