Large-area batch preparation method of ultrathin stretchable high-density myoelectrode array

Abstract

The invention discloses a large-area batch preparation method of an ultrathin stretchable high-density myoelectrode array, which comprises the following steps of: adhering an ultrathin soft elastic substrate on a releasable supporting layer, and preparing an electrode array and an interconnection wire on the ultrathin soft elastic substrate through silk-screen printing, an interconnection wire area used for being connected with external acquisition equipment is covered with wear-resistant conductive carbon paste and a hard backing material, and a plugging interface is formed in the area; in other areas of the ultra-thin soft elastic substrate, the electrode array is covered with biological conductive gel through a dispensing process, a non-electrode position is covered with a medical double-sided adhesion layer, and an ultra-thin soft sensing part is integrally formed; and a releasable protective layer covers the ultrathin soft sensing part. According to the preparation method, the problems of device wrinkles, difficulty in operation and low yield during large-area preparation of the ultrathin stretchable high-density myoelectrode array can be effectively solved, and reliable batch preparation of the large-area ultrathin stretchable high-density myoelectrode array can be realized.

Description

Technical Field

[0001] The invention belongs to the technical field of electrophysiological signal acquisition, and relates to a large-area batch preparation method of an ultra-thin stretchable high-density muscle electrode array. Background Art

[0002] Electrophysiological signal acquisition technology has a wide range of applications in the biomedical field, mainly used to monitor physiological activities such as heartbeat, brain function, and muscle contraction. As a key component for collecting epidermal physiological signals, the performance of the electrode array directly determines the signal quality and acquisition efficiency. Especially in the preparation process of high-density muscle electrode arrays, there have always been problems such as cumbersome and time-consuming preparation process, difficult to stretch electrodes and poor adaptation to the skin, and limited electrode preparation size. These bottlenecks of traditional preparation methods have severely limited the performance of high-density muscle electrode arrays in practical applications.

[0003] In order to solve the problems faced by the above-mentioned traditional electrode array architecture and its preparation method, the present invention introduces a new electrode array design, which adopts a soft-hard hybrid structure. The structure includes a releasable support layer, a releasable protective layer, an ultra-thin soft sensing part and a pluggable interface. Through this innovative architectural design, the present invention can not only effectively solve the problems in the large-area preparation of muscle electrode arrays, improve the yield rate of preparation, but also realize the reliable batch preparation of high-density muscle electrode arrays. The ultra-thin stretchable high-density muscle electrode array and its preparation method of the present invention have broad application prospects in the fields of biomedical research and clinical monitoring. The new electrode array architecture not only improves the accuracy and reliability of electrophysiological signal acquisition, but also provides an advanced and reliable method for large-area batch preparation. Summary of the invention

[0004] In order to solve the common process problems in the preparation process of ultra-thin stretchable high-density muscle electrode arrays: large-area preparation, rapid batch preparation and other problems, the present invention proposes a large-area batch preparation method for ultra-thin stretchable high-density electrode arrays, and proposes an innovative high-density electrode array architecture. Through the innovative electrode array hierarchical architecture design, a releasable support layer and a releasable protective layer are introduced to assist in the large-area preparation of electrodes and improve operability. In order to adapt to the dynamic large deformation of soft tissues such as muscles, a soft sensing part is specially introduced to ensure that the electrode is closely fitted to the skin, so as to stably collect high-density epidermal electrophysiological signals. At the same time, the design of a pluggable interface makes the electrode array more flexible and easy to operate in batch production. Through these designs, the present invention is committed to making the high-density electrode array have the characteristics of ultra-thin, stretchable and highly adaptable, while being able to achieve efficient batch preparation in large-area scenarios.

[0005] The technical solution adopted by the present invention is as follows:

[0006] A method for large-scale batch preparation of ultra-thin stretchable high-density muscle electrode arrays, comprising: after adhering an ultra-thin soft elastic substrate on a releasable support layer, preparing an electrode array and interconnecting wires on the ultra-thin soft elastic substrate by screen printing, covering the interconnecting wire area for connecting to an external acquisition device with wear-resistant conductive carbon paste and hard backing material, and forming a plug-in interface in the area; in other areas of the ultra-thin soft elastic substrate, covering the electrode array with conductive gel by a dispensing process, covering the non-electrode area with a medical double-sided adhesive layer, and forming an ultra-thin soft sensing part as a whole; covering the ultra-thin soft sensing part with a releasable protective layer.

[0007] In the above technical solution, further, the releasable support layer is made of PET, silicone rubber and other materials, the ultra-thin soft elastic substrate is made of PU or SEBS material, and the releasable protective layer is made of PET material.

[0008] Furthermore, the electrode array and interconnecting wires are implemented by screen-printing stretchable Ag / AgCl.

[0009] Furthermore, the hard material is made of hard PET material, especially hard thick PET material.

[0010] Furthermore, the conductive gel is conductive paste or conductive hydrogel.

[0011] Furthermore, the medical double-sided adhesive layer adopts acrylic double-sided skin adhesive.

[0012] A large-area ultra-thin stretchable high-density muscle electrode array comprises a releasable support layer, a releasable protective layer, an ultra-thin soft sensing part and a plug-in interface; the ultra-thin soft sensing part comprises a soft elastic substrate, an electrode array and interconnecting wires, a skin adhesion layer and a conductive gel; the ultra-thin soft elastic substrate is attached to the releasable support layer, the electrode array and the interconnecting wires are screen-printed on the ultra-thin soft elastic substrate, the interconnecting wire area used for output is covered with conductive carbon paste and hard material, and a plug-in interface is formed in this area, and in other areas, the electrode array is covered with conductive gel through a dispensing process, and the non-electrode area is covered with a skin adhesion layer. Except for the plug-in interface, the ultra-thin soft sensing part is covered with a releasable protective layer.

[0013] The releasable support layer is made of polyethylene terephthalate (PET) material, which is not only cheap, easy to use, and ultra-thin, but also can be used for large-area expansion. The ultra-thin soft elastic substrate is made of polyurethane (PU) material, which has softness, breathability, and ultra-thinness, and meets the requirements of long-term use of high-density electrode arrays. When using the ultra-thin soft sensing part to provide excellent electrode-skin contact, it is faced with the problem of easy wrinkling when using a large-area array. During preparation in the present invention, the ultra-thin soft elastic substrate in the ultra-thin soft sensing part is weakly adhered to the releasable support layer PET material. Thereby, the soft elastic substrate can be supported to facilitate operations such as screen printing thereon. When using the high-density muscle electrode array, due to the weak adhesion characteristics of the releasable support layer and the ultra-thin soft sensing part, the convenience of manual operation is effectively improved, and wrinkling and other phenomena can be effectively avoided.

[0014] The releasable protective layer is made of PET material, which has excellent sealing, plasticity, and ultra-thinness, and can effectively protect the ultra-thin soft sensing part to achieve long-term storage of the electrode array.

[0015] The ultra-thin soft sensing part is composed of an ultra-thin soft elastic substrate, a stretchable interconnect wire, a skin adhesive layer, and a conductive gel array. In the traditional rigid / flexible bendable electrode array, the structural design of this part is often not reasonable enough, resulting in the electrode being unable to show stretchable characteristics when accompanied by a large tensile deformation during the dynamic contraction of the muscle. This leads to the trouble of coordinated deformation of the electrode and the muscle tissue, especially when the muscle is dynamically contracted, it becomes extremely difficult to collect electrophysiological signals. There is a large stress on the interface between the electrode and the skin during use, and it is easy to debond, and thus it can only be applied to the situation of static muscle contraction. In the process of dynamic muscle contraction, the traditional electrode array faces the problem of large stress on the interface with the skin, and it is easy to debond, so the traditional electrode array is only applicable to the situation of static muscle contraction. The innovative design of the ultra-thin soft sensing part of the present invention successfully solves the difficulties of the traditional rigid / flexible bendable electrode array in dynamic muscle contraction, and realizes the distributed and accurate measurement of electromyographic signals under dynamic deformation. This design greatly expands the use scenarios of high-density muscle electrode arrays and overcomes the limitations encountered by traditional electrodes in the process of dynamic muscle contraction.

[0016] Preferably, the stretchable interconnect wire uses Ag / AgCl, which achieves stable acquisition of electrophysiological signals and stretchability to meet the requirements of dynamic muscle contraction.

[0017] Preferably, the skin adhesive layer uses an acrylic double-sided skin adhesive, which can strongly adhere the electrode array to the skin without damaging the skin and has strong biocompatibility.

[0018] Preferably, the conductive gel array uses conductive paste or conductive hydrogel, which can effectively reduce the electrode-skin impedance and improve the fidelity of the physiological signals collected by the electrode array.

[0019] The pluggable interface consists of flexible interconnects and solid contact pads, and is used to connect the ultra-thin soft sensing part and the rigid acquisition module.

[0020] Preferably, the pluggable interface is covered with conductive carbon paste to improve the stability of the pluggable interface during repeated use and enhance the mechanical reliability of the contact pad.

[0021] Preferably, the solid contact pad is made of hard thick PET material to provide reliable connection support for the pluggable interface.

[0022] The present invention has a novel architecture design for the electrode array, including a releasable support layer, a releasable protective layer, an ultra-thin soft sensing part and a pluggable interface. The use of the releasable support layer effectively alleviates the wrinkling problem that may occur when the electrode is in use, and is particularly helpful when manually operating a large-area electrode array. This design architecture enables the electrode array to be scalable and multi-layer screen-printed directly on a flexible material, thereby improving the preparation efficiency. The introduction of the releasable protective layer is intended to protect the ultra-thin soft sensing part and improve the stability of the large-area array. The ultra-thin soft sensing part significantly improves the adaptability to skin deformation and effectively improves the problem of insufficient skin adaptability of common rigid / flexible electrodes. The design of the pluggable interface ensures the durability of the pluggable interface during multiple uses. The advantage of this overall architecture design is that it can achieve batch preparation, stretchability, strong adaptability and other characteristics that cannot be achieved for common large-area arrays, while solving the problems that are difficult to overcome in the preparation and use of high-density electrode arrays. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 A schematic diagram of a specific example of a large-area ultra-thin stretchable high-density electrode array architecture of the present invention;

[0024] Figure 2 It is a structural schematic diagram of a soft sensing part in a specific example of the present invention;

[0025] Figure 3 The figure is a schematic diagram of the structure of a pluggable interface in a specific example of the present invention. DETAILED DESCRIPTION

[0026] The present invention will be further described below in conjunction with the accompanying drawings and specific embodiments.

[0027] like Figure 1As shown, it is a schematic diagram of a specific example of the large-area ultra-thin stretchable high-density electrode array architecture of the present invention, including a releasable protective layer 10, an ultra-thin soft sensing part 20, a pluggable interface 30 for communicating with a rigid acquisition module, and a releasable support layer 40.

[0028] According to a specific embodiment of the present invention, the releasable protective layer 10 is made of PET flexible material to protect the ultra-thin soft sensing part of the electrode array to extend the storage time of the large-area electrode array, thereby realizing batch preparation. During the production process, the releasable protective layer 10 needs to be bonded to the ultra-thin soft sensing part 20 to protect the ultra-thin soft sensing part 20 from the influence of oxidation, improve the stability of the large-area electrode array, and facilitate use. This design is intended to ensure that the ultra-thin soft sensing part 20 is fully protected during storage and preparation to maintain its performance and stability. The tail end of the ultra-thin soft sensing part 20 needs to be connected to a pluggable electrical interface 30 to provide an electrical interface for a standard flexible printed circuit connector to achieve communication with a rigid acquisition module. This design enables the electrode array to be conveniently and stably connected to the acquisition module when in use, ensuring reliable transmission of signals. The releasable support layer 40 is made of PET flexible material, and the ultra-thin soft sensing part 20 is weakly adhered to the releasable support layer 40 to act as a temporary support to reduce wrinkling during use, thereby reducing the difficulty of making a large-area electrode array. This innovative design enables large-area preparation of the entire electrode array, and the electrode array can effectively fit a large area of ​​skin, improving the comfort and fit of the electrode array.

[0029] like Figure 2 As shown, according to a specific example of the present invention, the soft sensing part 20 includes:

[0030] The acrylic-based double-sided skin adhesive 21 is used for isolating, encapsulating and bonding the skin, is biocompatible, and can be used for a long time without causing damage to the skin.

[0031] The stretchable conductive biogel 22 increases the conductivity of the electrode, improves the acquisition fidelity of electrophysiological signals, and enables the soft sensing part to flexibly adapt to the dynamic changes of the skin.

[0032] The Ag / AgCl electrode 23 is used as an electrode and a conductor to effectively transmit bio-electrophysiological signals and has stability and biocompatibility.

[0033] A large area of ​​ultra-thin soft PU 24 is used for screen printing of Ag / AgCl electrodes and is bonded with an acrylic-based double-sided skin adhesive. By using an ultra-thin soft material such as PU, the flexibility and fit of the soft sensing part are achieved, so that the soft sensing part is integrated on a large area of ​​ultra-thin soft PU. During production, a large area of ​​ultra-thin soft PU 24 is first used as a substrate, adhered to a releasable support layer 40, and the Ag / AgCl electrode 23 is accurately printed on the surface of the ultra-thin soft PU 24 by screen printing technology. This step is intended to ensure that the position of the electrode is accurate and neat, providing a reliable basis for subsequent electrophysiological signal acquisition. Subsequently, a dispensing process is used to cover the stretchable conductive biogel 22 at the printed electrode position to enhance the conductive properties of the electrode and improve the accuracy of electrophysiological signal acquisition. This design enables the soft sensing part to adapt to the dynamic changes of the skin while ensuring the accuracy of signal acquisition. Finally, the entire soft sensing part is bonded to the skin using an acrylic-based double-sided skin adhesive 21. This step not only provides a firm fixation, but also ensures a good fit between the soft sensing part and the skin, making the electrode more comfortable as a whole and able to effectively adapt to the dynamic changes of the skin. Through this design, the soft sensing part can stably and reliably collect electrophysiological signals during use.

[0034] like Figure 3 As shown, according to a specific example of the present invention, the pluggable interface 30 includes:

[0035] The flexible patch 31 made of PET material is used to protect the pluggable interface and improve the durability and long-term stability of the interface.

[0036] The Ag / AgCl electrode 32 covered with the conductive carbon paste improves the scratch resistance of the electrical interface, so that the interface can maintain good electrical performance during repeated use.

[0037] A solid PET material contact pad 33 is used to increase the firmness of the interface when connected to the FPC connector, thereby improving stability during use and ensuring the reliability and durability of the connection.

[0038] When making a pluggable interface, firstly, Ag / AgCl electrodes 32 covered with conductive carbon paste are printed on a flexible patch 31 made of PET material by screen printing technology. Then, a contact pad 33 made of solid PET material is fixed on the back of the interface. This step ensures that the structure of the entire interface is strong to adapt to the use scenarios of multiple connections and disconnections. With this design, the pluggable interface has excellent durability and stability, suitable for long-term use.

[0039] The above disclosure is only part of the preferred embodiments of the present invention, but the present application is not limited thereto. Any modifications or equivalent substitutions made by relevant technical personnel within the core theoretical scope of the present invention should fall within the protection scope of the present invention.

Claims

1. A method for large-scale batch preparation of ultra-thin stretchable high-density myoelectric electrode arrays, characterized in that: include: After adhering the ultra-thin soft elastic substrate to the releasable support layer, the electrode array and interconnecting wires are prepared on the ultra-thin soft elastic substrate by screen printing, and the interconnecting wire area used for connecting to the external collection equipment is covered with wear-resistant conductive carbon paste and hard backing material, and the area forms a plug-in interface; in other areas of the ultra-thin soft elastic substrate, the electrode array is covered with bio-conductive gel by a dispensing process, and the non-electrode area is covered with a medical double-sided adhesive layer, forming an ultra-thin soft sensing part as a whole; and the ultra-thin soft sensing part is covered with a releasable protective layer.

2. The large-area batch preparation method of ultra-thin stretchable high-density myoelectrode array according to claim 1, characterized in that: The releasable support layer is made of PET or silicone rubber material, the ultra-thin soft elastic substrate is made of PU or SEBS material, and the releasable protective layer is made of PET material.

3. The large-area batch preparation method of ultra-thin stretchable high-density myoelectrode array according to claim 1, characterized in that: The electrode array and interconnecting wires are realized by screen printing stretchable Ag / AgCl.

4. The large-area batch preparation method of ultra-thin stretchable high-density myoelectric electrode array according to claim 1, characterized in that: The hard backing material is made of hard thick PET material.

5. The large-area batch preparation method of ultra-thin stretchable high-density myoelectric electrode array according to claim 1, characterized in that: The biological conductive gel is conductive paste or conductive hydrogel.

6. The large-area batch preparation method of ultra-thin stretchable high-density myoelectrode array according to claim 1, characterized in that: The medical double-sided skin adhesive layer adopts medical acrylic double-sided skin adhesive.

7. A large-area ultra-thin stretchable high-density myoelectrode array, characterized in that: It includes a releasable support layer, a releasable protective layer, an ultra-thin soft sensing part and a plug-in interface; the ultra-thin soft sensing part includes an ultra-thin soft elastic substrate, an electrode array and interconnecting wires, a skin adhesion layer and a conductive gel; the ultra-thin soft elastic substrate is attached to the releasable support layer, the electrode array and the interconnecting wires are screen-printed on the ultra-thin soft elastic substrate, the interconnecting wire area used for output is covered with conductive carbon paste and a hard backing material, and a plug-in interface is formed in this area, and in other areas, the electrode array is covered with a conductive gel through a dispensing process, and the non-electrode area is covered with a skin adhesion layer. Except for the plug-in interface, the ultra-thin soft sensing part is covered with a releasable protective layer.

8. The large-area ultra-thin stretchable high-density myoelectrode array according to claim 7, characterized in that: The releasable support layer is made of PET or silicone rubber material, the ultra-thin soft elastic substrate is made of PU or SEBS material, and the releasable protective layer is made of PET material.

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