Anti-shedding electrode patch of wireless electrocardiogram monitor

Abstract

The invention discloses an anti-shedding electrode patch of a wireless electrocardiogram monitor, which relates to the technical field of medical electronic diagnosis and comprises an electrode patch main body, a shell layer, a conductive layer fixed at the bottom of the shell layer and a contact layer fixed at the bottom of the conductive layer; the anchoring unit is arranged in the center of the shell layer and comprises a supporting column arranged in the center of the shell layer and mechanical anchors arranged on the periphery of the supporting column. The electrode patch has the beneficial effects that the problem of unstable fixation of a traditional electrode patch in a sweat wet environment under the action of long-term monitoring and shearing force can be effectively solved through transverse fixation of the mechanical anchor and a longitudinal fixation mechanism during pasting and in combination with the self-adaptive pressure adjustment capability achieved by the supporting column; clinical inconvenience and patient discomfort caused by a traditional wire structure are reduced.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical electronic diagnosis, and particularly relates to a wireless electrocardiogram monitor anti-falling electrode patch. BACKGROUND

[0002] As the core part of modern medical monitoring system, the electrode patch technology of electrocardiogram monitoring has experienced evolution from simple conductive glue to complex multifunctional composite electrode patch. The traditional electrocardiogram monitoring electrode patch mainly relies on conductive gel and adhesive material to build the interface between the skin and the electrode patch, and adopts Ag / AgCl conductive medium to realize bioelectric signal acquisition. However, this single adhesion fixed interface structure faces many technical limitations. First, the adhesion fixed mechanism is significantly affected by sweat secretion and skin oil distribution, resulting in exponential decay of adhesion ability during long-term monitoring (more than 24 hours); second, the shear force and transverse stress generated by the change of patient's body position or external force interference often causes progressive separation from the edge of the electrode patch; third, the single point fixed mode adopted by the current mainstream electrode patch makes the anti-interference ability of the whole system seriously dependent on the local adhesion state, and once the local separation occurs, it will cause a chain failure; finally, due to the limitation of the structure of the traditional electrode patch, there is no corresponding pressure dispersion mechanism when the patient turns over and is pressed, which not only accelerates the damage of the electrode patch structure, but also forms a pressure sore risk point because the lead and connector are pressed between the body and the bed surface, and causes significant obstacles to the daily nursing operation of medical staff.

[0003] Another technical bottleneck of the current clinical electrocardiogram monitor electrode patch system is reflected in the complex and lengthy lead system. These leads not only increase the overall complexity and failure points of the system, but also often cause poor contact due to mechanical stress. Especially for postoperative recovery or intensive care patients, the activity restriction and discomfort caused by the lead system directly affect the rehabilitation effect and monitoring compliance. In a hot and humid environment, the adhesion decline and signal quality fluctuation of the traditional electrode patch are particularly prominent, which leads medical staff to frequently replace the electrode patch, increasing the discomfort of the patient and the consumption of medical resources. These technical deficiencies together constitute the key pain points in the current electrocardiogram monitoring system, and a breakthrough fixing mechanism is urgently needed to balance the contradiction between monitoring stability and patient comfort. SUMMARY

[0004] In view of the above or the problems existing in the prior art, the present application is proposed.

[0005] Therefore, the purpose of the present application is to provide a wireless electrocardiogram monitor anti-falling electrode patch which can solve the problems mentioned in the background art.

[0006] To solve the above technical problems, the present invention provides the following technical solution: a wireless electrocardiogram monitor anti-drop electrode patch, which includes an electrode patch body, including an outer shell layer, a conductive layer fixed to the bottom of the outer shell layer, and a contact layer fixed to the bottom of the conductive layer; An anchoring unit is disposed at the center of the outer shell layer. The anchoring unit includes a support column disposed at the center of the outer shell layer and mechanical anchors disposed around the support column.

[0007] As a preferred embodiment of the anti-detachment electrode patch for the wireless ECG monitor of the present invention, the outer shell layer includes an elastic cavity at its center, a plurality of extended cavities communicating with the elastic cavity, a plurality of electronic integrated cavities between the extended cavities, and a telescopic cavity at the outward end of the extended cavity. As a preferred embodiment of the anti-detachment electrode patch for the wireless ECG monitor of the present invention, the elastic cavity includes a flexible ring fixed at the opening, a flexible wall fixed at the bottom of the elastic cavity, and a plurality of limiting posts fixed to the inner wall of the elastic cavity. The extension cavity includes a stop block disposed at an opening adjacent to the elastic cavity, and a plurality of spring pieces fixed to the cavity wall of the extension cavity.

[0008] As a preferred embodiment of the anti-detachment electrode patch for the wireless ECG monitor of the present invention, wherein: the outermost spring piece at the end of the extension cavity completely seals the opening of the extension cavity; each of the spring pieces is distributed along the extension direction of the extension cavity.

[0009] As a preferred embodiment of the anti-detachment electrode patch for the wireless ECG monitor of the present invention, wherein: the number of elastic strips is consistent with and corresponds to the extension cavity, and the elastic strips penetrate through the interior of the extension cavity; the elastic strips penetrate through each of the spring pieces inside the extension cavity and are fixedly connected to the last spring piece.

[0010] As a preferred embodiment of the anti-detachment electrode patch for the wireless ECG monitor of the present invention, the lifting ring is U-shaped and includes pry bars fixed to both ends of its hinge shaft.

[0011] As a preferred embodiment of the anti-detachment electrode patch for the wireless ECG monitor of the present invention, the mechanical anchor includes an anchor base, an anchor shoulder fixed to one end of the anchor base, and an anchor tip fixed to one end of the anchor shoulder. The mechanical anchor is arc-shaped; the tip of the anchor is rounded.

[0012] As a preferred scheme of the wireless electrocardiogram monitor electrode patch, the shell layer further comprises a plurality of wiring cavities in communication with each of the electronic integrated cavities; and none of the electronic integrated cavities and the wiring cavities is in communication with any of the elastic cavities and any of the extension cavities.

[0013] The present application has the following advantages: the present application can effectively solve the instability of the traditional electrode patch in the sweat environment, long-term monitoring and shear force, reduce the clinical inconvenience and patient discomfort caused by the traditional lead structure, and has significant advantages in the aspects of fixing reliability improvement, comfort optimization, service life extension, nursing convenience improvement and the like. BRIEF DESCRIPTION OF DRAWINGS

[0014] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed in the embodiment description will be briefly introduced. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative labor.

[0015] Figure 1 It is a three-dimensional view of the present application.

[0016] Figure 2 It is a top view of the present application.

[0017] Figure 3 It is a partial structure view of the present application. Figure 2 It is an A-A full section view of the present application.

[0018] Figure 4 It is a B-B full section view of the present application. Figure 2

[0019] Figure 5 It is a partial structure view of the mechanical anchor of the present application.

[0020] Figure 6 It is a partial section view of the shell layer of the present application.

[0021] Figure 7 It is a schematic view of the principle of the present application.

[0022] ​In the figure: 1, electrode patch main body; 11, shell layer; 12, conductive layer; 13, contact layer; 2, anchoring unit; 21, support; 22, mechanical anchor; 111, elastic cavity; 112, extension cavity; 113, electronic integration cavity; 114, telescopic cavity; 1111, flexible ring; 1112, flexible wall; 1113, limiting column; 1121, stop block; 1122, elastic sheet; 211, limiting groove; 212, elastic strip; 213, lifting ring; 2131, pry bar; 221, anchor base; 222, anchor shoulder; 223, anchor tip; 115, wiring cavity. DETAILED DESCRIPTION

[0023] In order to make the above-mentioned objectives, features and advantages of the present application more obvious and easy to understand, the specific embodiments of the present application will be described in detail below with reference to the accompanying drawings.

[0024] In the following description, a large number of specific details are set forth in order to facilitate a thorough understanding of the present application, but the present application can also be implemented in other ways different from the description, and those skilled in the art can make similar generalizations without departing from the concept of the present application, therefore the present application is not limited to the specific embodiments disclosed below.

[0025] Secondly, "one embodiment" or "embodiment" referred to herein means that a specific feature, structure or characteristic can be included in at least one implementation of the present application. "In one embodiment" appearing in different places in the specification does not mean the same embodiment, nor does it mean an embodiment that is separate or selectively excluded from other embodiments.

[0026] Reference Figures 1-7 The present embodiment provides a wireless electrocardiogram monitor anti-falling electrode patch, which comprises an electrode patch main body 1, a shell layer 11, a conductive layer 12 fixed to the bottom of the shell layer 11, and a contact layer 13 fixed to the bottom of the conductive layer 12; An anchoring unit 2 is arranged at the center of the shell layer 11, and the anchoring unit 2 comprises a support 21 arranged at the center of the shell layer 11 and a mechanical anchor 22 arranged around the support 21.

[0027] Further, the shell layer 11 comprises an elastic cavity 111 opened at the center, a plurality of extension cavities 112 communicated with the elastic cavity 111, a plurality of electronic integration cavities 113 opened between each extension cavity 112, and a telescopic cavity 114 opened at the outer side end of the extension cavity 112.

[0028] Further, the elastic cavity 111 comprises a flexible ring 1111 fixed at the opening, a flexible wall 1112 fixed at the bottom of the elastic cavity 111, and a plurality of limiting columns 1113 fixed to the inner wall of the elastic cavity 111; The extension cavity 112 comprises a stopper 1121 arranged at the opening of the elastic cavity 111, and a plurality of elastic pieces 1122 fixed to the cavity wall of the extension cavity 112.

[0029] Further, the outermost elastic piece 1122 of the end of the extension cavity 112 completely seals the opening of the extension cavity 112, and each elastic piece 1122 is distributed along the extension direction of the extension cavity 112.

[0030] Further, the support 21 comprises a plurality of limiting grooves 211 arranged at the bottom edge thereof, a plurality of elastic strips 212 fixed to the side wall of the support 21, and a lifting ring 213 hingedly connected to the top of the support 21.

[0031] Further, the number of the elastic strips 212 is consistent with and corresponds to the extension cavity 112, and the elastic strips 212 penetrate into the extension cavity 112; the elastic strips 212 penetrate into each elastic piece 1122 in the extension cavity 112 and are fixedly connected to the last elastic piece 1122.

[0032] Further, the lifting ring 213 is in the shape of a mouth, comprising pry bars 2131 fixed to both ends of the hinged shaft thereof.

[0033] Further, the mechanical anchor 22 comprises an anchor base 221, an anchor shoulder 222 fixed to one end of the anchor base 221, and an anchor tip 223 fixed to one end of the anchor shoulder 222. The mechanical anchor 22 is in the shape of an arc, and the tip of the anchor tip 223 is smoothly processed.

[0034] Further, the shell layer 11 further comprises a plurality of wiring cavities 115 communicating with each electronic integrated cavity 113; neither the electronic integrated cavity 113 nor the wiring cavity 115 communicates with any elastic cavity 111 or any extension cavity 112.

[0035] In an embodiment provided in the present application, the entire electrode patch is in the shape of a flat, and the upper surface thereof is flat without traditional convex-shaped wire connectors; the electrode patch is fixed from top to bottom by the shell layer 11, the conductive layer 12, and the contact layer 13.

[0036] As an optional embodiment, the conductive layer 12 is constructed by using high-purity silver / silver chloride, i.e., Ag / AgCl composite material; the layer is composed of an Ag / AgCl electrode patch layer and a conductive substrate to form a double-layer structure, thereby forming an ideal ion / electron conversion interface. The edge of the conductive layer 12 needs to be chamfered and smoothly transitioned, which can eliminate stress concentration points and avoid signal edge effects.

[0037] Furthermore, the conductive layer 12 is electrically isolated from the mechanical anchor 22, ensuring that the physical fixing function of the mechanical anchor 22 does not interfere with the acquisition of electrical signals. In terms of material selection, in addition to standard Ag / AgCl, nanoscale carbon materials can also be added as conductive enhancers to improve the mechanical flexibility and electrical conductivity stability of the conductive layer 12, enabling it to adapt to changes in mechanical stress in long-term monitoring applications.

[0038] As an optional embodiment, contact layer 13 employs a highly conductive hydrogel, which can delay moisture evaporation and maintain stable conductivity over a long period. The pH value of the gel needs to be controlled within the range of 5.5-6.0 to match the natural pH of the skin, minimizing skin irritation during long-term contact. A thin sealing layer made of medical-grade silicone is provided at the edge of contact layer 13, forming a flexible transition zone to prevent sweat from seeping into the conductive area and to prevent the gel components from diffusing outward.

[0039] Preferably, an elastic cavity 111 is formed at the center of the outer shell layer 11. The elastic cavity 111 does not penetrate the bottom of the outer shell layer 11, but several extension cavities 112 are connected around the elastic cavity 111. The extension cavities 112 extend obliquely from the center of the elastic cavity 111 to the bottom edge of the outer shell layer 11, but do not penetrate to the outside. In this embodiment, four extension cavities 112 are evenly distributed circumferentially.

[0040] Several electronic integrated cavities 113 are provided between each extension cavity 112, and are not connected to the extension cavity 112 or the elastic cavity 111. Each electronic integrated cavity 113 is connected through an independent wiring cavity 115.

[0041] As an optional embodiment, the electronic integrated cavity 113 is used to house a signal acquisition and conditioning module, which includes a high-precision bioelectric amplifier, a filter circuit and a 24-bit Σ-Δ ADC, a signal processing and analysis module that performs real-time signal processing and heart rhythm analysis based on a low-power 32-bit microcontroller, a wireless communication module that uses the BLE5.2 protocol to achieve encrypted data transmission, and a power management module that integrates a micro lithium battery and low-power control circuitry.

[0042] The electronic modules are reliably pressed together with the conductive layer 12 via double-gold-plated silver elastic contacts. Specifically, electrical signal transmission is achieved by fixing several contacts through the bottom of the electronic integrated cavity 113 and pressing them together with the conductive layer 12. The entire connection area must meet waterproof sealing requirements and pass a high-strength bending cycle test to ensure signal acquisition stability and structural reliability in various clinical application scenarios. Wires between the electronic integrated cavities 113 in different areas can pass through a pre-designed wiring cavity 115 for connecting the various modules. The wiring cavity 115 is also independent of the extension cavity 112 and the elastic cavity 111 and is not connected to either of them.

[0043] In addition, a connector is provided on the side wall of one of the electronic integration cavities 113, which can be used for power charging or to establish an information channel between the electronic module and the outside.

[0044] Preferably, a flexible ring 1111 is fixed at the opening edge of the elastic cavity 111, while the bottom of the elastic cavity 111 is composed of a flexible wall 1112. Both the flexible ring 1111 and the flexible wall 1112 can deform. A plurality of circumferentially evenly distributed limiting posts 1113 are also fixed on the inner wall of the elastic cavity 111. In this embodiment, four posts are used.

[0045] Preferably, at the location adjacent to the elastic cavity 111 inside each extension cavity 112, that is, inside the opening of the extension cavity 112, there is a stop block 1121 fixed to the bottom of the extension cavity 112, and the corners of the stop block 1121 are all chamfered. In addition, a number of spring pieces 1122 distributed along the drawing direction are fixed inside each extension cavity 112. The spring pieces 1122 are shell-like structures in the shape of a frustum or a truncated cone. This structure can ensure that the spring pieces 1122 maintain the frustum or truncated cone state or deform into the opposite frustum or truncated cone state after being subjected to force.

[0046] As an alternative implementation, the spring 1122 can be a frustum or truncated cone shell, or it can be a cone or hemispherical shape, as long as it can undergo bidirectional deformation.

[0047] The bottom edge of the spring piece 1122 is completely fixed to the inner wall of the extension cavity 112, forming a sealing effect. The spring piece 1122 at the outermost position of the end of the extension cavity 112 needs to completely block the opening to ensure that the extension cavity 112 is not connected to the outside. In this embodiment, two spring pieces 1122 are used, but each extension cavity 112 requires at least one spring piece 1122 that completely blocks the opening.

[0048] At the outermost end of each extension cavity 112, a downwardly oriented telescopic cavity 114 is provided. The telescopic cavity 114 is arc-shaped, and its two ends are connected to the outside and the extension cavity 112, respectively.

[0049] Preferably, the support column 21 is cylindrical, and several limiting grooves 211 are formed around the side wall of the support column 21. The limiting grooves 211 only penetrate the bottom of the support column 21, and their number is the same as that of the limiting posts 1113, and the two cooperate with each other. Therefore, the support column 21 can be installed inside the elastic cavity 111 and can only move axially. The opening of the flexible ring 1111 is fixed to the edge of the upper end face of the support column 21, so that the internal space of the elastic cavity 111 is closed.

[0050] Preferably, the elastic strips 212 are located inside the extension cavity 112, and the number of elastic strips 212 is the same as that of the extension cavity 112. One end of the elastic strip 212 is fixedly connected to the side wall of the support column 21, and the other end is fixedly connected to the last elastic piece 1122, while the remaining elastic pieces 1122 are penetrated by the elastic strip 212 and fixed between them. Therefore, when the support column 21 moves along its own axial direction, it will drag the elastic strip 212 to extend and retract inside the extension cavity 112, and each elastic piece 1122 will also deform accordingly.

[0051] Preferably, the mechanical anchor 22 is composed of an anchor base 221, an anchor shoulder 222, and an anchor tip 223 arranged in an arc shape and fitted inside the telescopic cavity 114. The anchor base 221 is fixedly connected to the center of the outermost elastic piece 1122, while the anchor shoulder 222 and the anchor tip 223 extend outside the telescopic cavity 114. When the elastic strip 212 extends or retracts, the mechanical anchor 22 will also extend or retract accordingly through the elastic piece 1122.

[0052] The mechanical anchor 22 is arc-shaped, and the anchor tip 223 is extremely thin and has smooth edges. It can be slightly embedded in the stratum corneum of the epidermis without penetrating it. The mechanical anchor 22 does not actually puncture or penetrate, but uses microscopic adhesion and fitting to produce a slight wedging effect when subjected to lateral force.

[0053] Preferably, the maximum contact depth of the anchor tip 223 is completely within the painless stratum corneum. Even under maximum pressure, the limiting mechanism of the anchor shoulder 222 ensures that the anchor tip 223 will not embed beyond the stratum corneum of the buttocks, because the stratum corneum is composed of dead keratinocytes and has no nerve endings or blood vessels, thus causing no pain. In addition, the anchor tip 223 needs to have sufficient safety margin.

[0054] As a preferred embodiment, the anchor tip 223, under the limiting mechanism of the anchor shoulder 222, should be embedded in the stratum corneum to a depth not exceeding 10 micrometers, while the thickness of the stratum corneum is typically 10-20 micrometers.

[0055] As a preferred embodiment, the mechanical anchor 22 is made of a biocompatible soft polymer material, such as medical TPE; the surface of the mechanical anchor 22 can be textured with micron-level textures, especially the anchor tip 223, which can interlock with the irregular structure of the skin surface.

[0056] Furthermore, the mechanical anchor 22 gradually thins from the anchor base 221 to the anchor shoulder 222 and then to the anchor tip 223, gradually increasing the flexibility of the mechanical anchor 22 and forming a self-limiting force. The greater the contact force, the more obvious the bending of the anchor tip 223, preventing it from going too deep. The circumferentially uniformly distributed mechanical anchors 22 are radially arranged, providing a multi-point fixing effect. In this embodiment, four mechanical anchors 22 of the same length are used, but in practice, different lengths and different distributions can be used.

[0057] In a preferred embodiment, since the elastic cavity 111 and the extension cavity 112 are in a closed state, their closed spaces are filled with silicone oil. As a hydraulic medium, the silicone oil can provide a damping effect, making the movement of the mechanical anchor 22 smooth and non-abrupt, ensuring that each mechanical anchor 22 is subjected to uniform force; it can also provide hydraulic buffer when suddenly compressed, preventing the mechanical anchor 22 from suddenly retracting and protecting the internal mechanism from damage.

[0058] Preferably, when the support 21 moves, it forces the silicone oil to flow and change position. A certain gap is left between the bottom of the flexible wall 1112 and the conductive layer 12. When the silicone oil accumulates inside the elastic cavity 111, the flexible wall 1112 will occupy the gap space accordingly, and vice versa, the gap will be expanded.

[0059] Because the silicone oil needs to flow freely, the inner diameter of the elastic cavity 111 needs to be larger than the outer diameter of the support column 21. In addition, the fit between the limiting groove 211 and the limiting post 1113 is also to enable the support column 21 to resist lateral forces and prevent the mechanical anchor 22 from being affected by lateral forces, causing it to partially retract while the other part extends further, resulting in the mechanical anchor 22 damaging the skin.

[0060] Better, refer to Figure 1 A lifting ring 213 is also hinged to the top of the support column 21. Specifically, the lifting ring 213 is semi-circular, and a thin shaft is fixed at both ends of the semi-circle. The thin shaft passes through the top of the support column 21, and the lifting ring 213 can rotate around the thin shaft. The support column 21 is also adapted to have a step to accommodate the lifting ring 213, so that when the lifting ring 213 is in contact with the top of the support column 21, it remains horizontal with the top of the support column 21.

[0061] When the lifting ring 213 is lifted, it can force the support 21 to move upward, so that the mechanical anchor 22 can retract.

[0062] In a preferred embodiment, the lifting ring 213 is further fixed with two levers 2131 perpendicular to the thin shaft at both ends. When the lifting ring 213 is rotated, the levers 2131 can lift the support column 21 by pressing against the surface of the outer shell layer 11. Compared with directly lifting the lifting ring 213, this method is more convenient and stable when the electrode patch is applied to the skin surface. It should be noted that a shallow groove needs to be made on the surface of the outer shell layer 11 to embed the levers 2131. The shallow groove is located at the position where the levers 2131 are projected onto the outer shell layer 11, and the shallow groove is not connected to the elastic cavity 111 to prevent the support column 21 from being obstructed by the levers 2131 when it is pressed down.

[0063] The practical operation involves three processes: attaching the electrode patches, applying pressure to the electrode patches, and removing the electrode patches. It is important to note that... Figures 2-5 When the electrode patch is in an unstressed state, that is, in its natural state, the surface of the support 21 is at position h2.

[0064] Reference Figure 7 When attaching the electrode pads, rotating the lifting ring 213 causes the support column 21 to be lifted with the end of the pry bar 2131 as the fulcrum. The support column 21 is lifted to position h1, and deformation occurs at point A on the flexible ring 1111. At this time, the elastic strip 212 is pulled back, and point C on the elastic strip 212 is also bent and deformed accordingly. The elastic strip 212 simultaneously pulls the various spring pieces 1122 and the mechanical anchor 22 back. Since the spring piece 1122 is a frustum or truncated cone shell in this embodiment, it also deforms at point E due to the pull of the spring piece 1122, forming a reverse frustum or truncated cone shape. Since the elastic cavity 111 and the extension cavity 112 are filled with silicone oil, the flexible wall 1112 also deforms at point B when the support column 21 moves, creating a larger gap between it and the conductive layer 12.

[0065] Furthermore, if the lifting ring 213 is pulled directly without the pry bar 2131, one hand is needed to apply both pulling and pressing force to the lifting ring 213 and the outer shell layer 11 simultaneously, requiring the assistance of both hands to complete the normal pasting work. However, with the pry bar 2131, rotating the lifting ring 213 will cause the support column 21 to be lifted by the pry bar 2131, and the pry bar 2131 can even maintain the lifted state, eliminating the need to use hands to keep the support column 21 in a lifted state, which is more convenient. At this time, the pry bar 2131 is subjected to reaction forces from deformation at various points.

[0066] After the electrode patch is applied, rotate the lifting ring 213 in the opposite direction so that the lifting ring 213 fits against the upper surface of the support 21. At this time, points A, C, E and B will automatically reset, the surface of the support 21 will return to position h2, and the anchor tip 223 of the mechanical anchor 22 will slightly unfold to form a shallow skin lock. At this time, the application and anchoring of the electrode patch are completed.

[0067] If sudden pressure is encountered, such as when the electrode patch is hit by a foreign object or during the patient's turning over, the support 21 will be compressed and retract to position h3 under the cushioning of the silicone oil. At this time, points A, C, E, and B will also undergo corresponding topographic changes. It should be noted that because the elastic strip 212 is tightly attached to the abutment 1121, the deformation response of the elastic strip 212 at point D will be very rapid when the support 21 retracts. The downward movement of the elastic strip 212 will be restricted by the edge of the abutment 1121. Therefore, the bending deformation that occurs at point D will cause the end of the elastic strip 212 to pull the mechanical anchor 22 back again. The greater the pressure, the greater the anchor contraction angle, reducing irritation to the skin. The cushioning of the silicone oil can prevent the mechanical anchor 22 from penetrating deeper into the electrode patch when it encounters sudden pressure, causing accidental trauma. Without the abutment 1121, the elastic strip 212 will extend in all directions, which may force the mechanical anchor 22 to penetrate deeper into the skin.

[0068] It should be noted that, in order to reduce irritation to sensitive skin and improve patient comfort, especially if the mechanical anchor 22 does not retract, when the patient turns over and presses on the electrode, the external force will forcibly press the mechanical anchor 22 into the skin. Even if the mechanical anchor 22 is designed with a blunt tip, there is still a potential risk of puncture under high pressure. The retraction mechanism allows the mechanical anchor 22 to actively give way when under pressure, fundamentally eliminating the safety hazard. Without the contraction function, a noticeable hard object will be formed at the pressure point, causing discomfort, especially for patients under long-term monitoring. Comfort directly affects compliance. Therefore, the contraction function of the mechanical anchor 22 allows patients to remain comfortable in various positions.

[0069] Furthermore, it should be noted that when the electrode patch is not under pressure, the patient can hardly perceive the presence of the mechanical anchor 22. However, when the patient turns over, causing pressure on the electrode patch, the skin is relatively soft. At this time, even if the mechanical anchor 22 has a mechanism to prevent excessive penetration, such as the anchor tip 223 needing to have sufficient safety margin, and the self-limiting force generated by the shape of the mechanical anchor 22 from thick to thin, it is also necessary to avoid the possibility of the anchor tip 223 of the mechanical anchor 22 being misaligned due to skin deformation under pressure, thus preventing excessive puncture. For example, the limiting mechanism of the anchor shoulder 222 can prevent the anchor tip 223 from being accidentally penetrated deeper due to skin deformation, even if this possibility is small.

[0070] When the pressure on the electrode patch ends, that is, when the external force on the surface of the support 21 disappears, points A, C, E, B and D all reset themselves, and the upper surface of the support 21 returns to position h2. The mechanical anchor 22 re-inserts into the epidermis and then anchors the electrode patch again.

[0071] When it is necessary to remove the electrode patch, rotate the lifting ring 213 to retract the mechanical anchor 22, and then continue to pull to remove the electrode patch.

[0072] This invention constructs an electrode patch with enhanced shear force resistance through anchoring. Unlike traditional electrode patches that rely solely on adhesive fixation, the radial mechanical anchors 22 in this invention can form an interlocking effect with the microstructure of the skin surface, producing a slight wedging effect when subjected to lateral forces, significantly improving lateral fixation force. Especially in sweaty conditions, when the effectiveness of conventional adhesive fixation significantly decreases, the mechanical anchor 22 fixation system still maintains stable performance, which is highly effective for long-term monitoring of patients with excessive sweating and fever.

[0073] Furthermore, this invention achieves a dynamic balance between maximum anchoring force and minimum irritation. The elastic cavity 111 built into the electrode patch enables the mechanical anchor 22 to adaptively adjust its contraction action according to external pressure. When the patient's position changes and the electrode patch is compressed, the mechanical anchor 22 is driven to automatically contract. The internal silicone oil can also assist in the drive, providing a damping effect, making the movement of the anchor smooth and non-abrupt, and ensuring that each anchor is subjected to uniform force. In the event of sudden pressure, a hydraulic buffer protection mechanism is provided to prevent damage.

[0074] This contraction mechanism ensures that the anchor tip 223 will not penetrate deep into the skin under external force, fundamentally eliminating the risk of puncture. The maximum contact depth of the mechanical anchor 22 is less than the thickness of the stratum corneum, approximately 10-20 micrometers, while the anchor shoulder 222 limits the maximum depth to which the anchor tip 223 penetrates the skin. The self-limiting force characteristic of the mechanical anchor 22 itself, which is thicker than it is thinner, ensures that it will not penetrate to the painful epidermal living cell layer, providing an unprecedentedly comfortable experience for patients with sensitive skin and for long-term monitoring scenarios.

[0075] This invention employs a wireless design, solving the clinical problems of messy wires, easy detachment, and pressure sores caused by traditional electrocardiogram monitoring systems.

[0076] The integrated signal processing and wireless transmission modules in the electrode patches eliminate physical connection limitations, significantly improving patient freedom of movement and ease of care. This is particularly beneficial for postoperative recovery and intensive care patients, significantly improving the monitoring experience and nursing efficiency. The disc-shaped structure of the electrode patches, thicker in the center and thinner at the edges, effectively reduces edge stress concentration when the patches contact the bed surface, extending their lifespan and reducing replacement frequency.

[0077] In summary, this invention strikes a balance between fixation reliability and skin comfort. The synergistic effect of the mechanical anchor 22 and the adhesive fixation of the contact layer 13 creates a complementary and reinforcing effect rather than a simple additive one. The electrode patch is easy and intuitive to apply and remove, facilitating rapid clinical application without damaging the skin. Therefore, this invention offers significant comprehensive advantages in terms of fixation reliability, user comfort, ease of operation, and system integration, providing a more reliable, comfortable, and convenient technical solution for long-term ECG monitoring.

[0078] Importantly, the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. 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 technical solutions of the present invention, and all such modifications or substitutions should be covered within the scope of the claims of the present invention.

Claims

1. A wireless electrocardiogram (ECG) monitor anti-fall-off electrode patch, characterized in that: include, The electrode patch body (1) includes an outer shell layer (11), a conductive layer (12) fixed to the bottom of the outer shell layer (11), and a contact layer (13) fixed to the bottom of the conductive layer (12). An anchoring unit (2) is disposed at the center of the outer shell layer (11). The anchoring unit (2) includes a support column (21) disposed at the center of the outer shell layer (11) and a mechanical anchor (22) disposed around the support column (21).

2. The anti-fall-off electrode patch for the wireless ECG monitor as described in claim 1, characterized in that: The outer shell layer (11) includes an elastic cavity (111) at its center, a plurality of extension cavities (112) communicating with the elastic cavity (111), a plurality of electronic integrated cavities (113) between each of the extension cavities (112), and a telescopic cavity (114) at the outward end of the extension cavity (112).

3. The anti-fall-off electrode patch for the wireless ECG monitor as described in claim 2, characterized in that: The elastic cavity (111) includes a flexible ring (1111) fixed at the opening, a flexible wall (1112) fixed at the bottom of the elastic cavity (111), and a plurality of limiting posts (1113) fixed at the inner wall of the elastic cavity (111). The extension cavity (112) includes a stop block (1121) disposed at an opening adjacent to the elastic cavity (111), and a plurality of spring pieces (1122) fixed to the cavity wall of the extension cavity (112).

4. The anti-fall-off electrode patch for the wireless ECG monitor as described in claim 3, characterized in that: The outermost spring piece (1122) at the end of the extension cavity (112) completely closes the opening of the extension cavity (112); each of the spring pieces (1122) is distributed along the extension direction of the extension cavity (112).

5. The anti-fall-off electrode patch for a wireless ECG monitor as described in claim 4, characterized in that: The support column (21) includes several limiting grooves (211) opened at its bottom edge, several elastic strips (212) fixed to the side wall of the support column (21), and a lifting ring (213) hinged to the top of the support column (21).

6. The anti-fall-off electrode patch for a wireless ECG monitor as described in claim 5, characterized in that: The number of elastic strips (212) is consistent with and corresponds to the extension cavity (112). The elastic strips (212) penetrate through the interior of the extension cavity (112). The elastic strips (212) penetrate through each of the spring pieces (1122) inside the extension cavity (112) and are fixedly connected to the last spring piece (1122).

7. The anti-fall-off electrode patch for a wireless ECG monitor as described in claim 6, characterized in that: The lifting ring (213) is U-shaped and includes pry bars (2131) fixed to both ends of its hinge shaft.

8. The anti-fall-off electrode patch for a wireless ECG monitor as described in claim 7, characterized in that: The mechanical anchor (22) includes an anchor base (221), an anchor shoulder (222) fixed to one end of the anchor base (221), and an anchor tip (223) fixed to one end of the anchor shoulder (222). The mechanical anchor (22) is arc-shaped; the tip of the anchor tip (223) is rounded.

9. The anti-fall-off electrode patch for a wireless ECG monitor as described in claim 8, characterized in that: The outer shell layer (11) also includes a plurality of wiring cavities (115) that connect each of the electronic integrated cavities (113); neither the electronic integrated cavity (113) nor the wiring cavity (115) is connected to any of the elastic cavity (111) and any of the extension cavity (112).

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