CN103462601A - Medical electrode plaster and preparation method thereof - Google Patents
Medical electrode plaster and preparation method thereof Download PDFInfo
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- CN103462601A CN103462601A CN2013104401001A CN201310440100A CN103462601A CN 103462601 A CN103462601 A CN 103462601A CN 2013104401001 A CN2013104401001 A CN 2013104401001A CN 201310440100 A CN201310440100 A CN 201310440100A CN 103462601 A CN103462601 A CN 103462601A
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Abstract
本发明涉及一种医用电极贴，包括：柔性可拉伸体表电极，包括柔性基底、电极单元、电极引线、引线连接点和绝缘层，电极单元、电极引线及引线连接点共同组成电极组件，电极组件设于柔性基底上，电极单元经由电极引线连接到引线连接点，绝缘层设于所述柔性基底上并覆盖所述电极引线，柔性基底和绝缘层的材质为聚二甲基硅氧烷；保护膜，覆盖电极组件从而形成保护。本发明还涉及一种医用电极贴的制备方法。本发明的医用电极贴具有良好的柔韧性和形变能力及良好的生物相容性，能够与皮肤形成良好的共形贴附，可以用于肘、腕、膝等经常大幅运动的关节处。
The invention relates to a medical electrode paste, comprising: a flexible and stretchable body surface electrode, including a flexible base, an electrode unit, an electrode lead, a lead connection point and an insulating layer, and the electrode unit, the electrode lead and the lead connection point together form an electrode assembly. The electrode assembly is arranged on a flexible base, the electrode unit is connected to the lead connection point through the electrode lead, the insulating layer is arranged on the flexible base and covers the electrode lead, and the material of the flexible base and the insulating layer is polydimethylsiloxane ; Protective film, covering the electrode assembly to form a protection. The invention also relates to a preparation method of the medical electrode paste. The medical electrode patch of the present invention has good flexibility, deformation ability and good biocompatibility, can form a good conformal attachment with the skin, and can be used in joints such as elbows, wrists, and knees that often move greatly.
Description
Technical Field
The invention relates to the field of medical equipment, in particular to a medical electrode paste and a preparation method of the medical electrode paste.
Background
When medical diagnosis or corresponding research is carried out, the in-vivo electric potential of a human body or a researched animal needs to be measured and recorded, and in addition, the percutaneous electric stimulation is a means which is frequently used in clinic to assist disease treatment. When various medical measuring instruments carry out bioelectricity detection and apply electric stimulation to a patient for auxiliary treatment, electric signals need to be transmitted by contacting the proper electrodes with the body. Body surface electrodes are currently the most common and widely used electrode, and are widely used in clinics due to non-invasiveness, such as: the cap type electrode is worn to record scalp electroencephalogram so as to carry out sleep monitoring and intensive care; recording electrocardiosignals through a body surface electrocardio-electrode to diagnose heart diseases; the application of electrical stimulation through the electrodes treats pain conditions such as migraine.
Currently, medical body surface electrodes are mainly classified into the following two types: wet electrodes and dry electrodes. The wet electrode is an electrode that needs to be used in combination with a conductive paste. Before use, the conductive paste is coated on the surface of the electrode or the skin of a subject to enhance the electrical contact between the electrode and the subject and reduce the impedance. The wet electrode used clinically at present can be divided into several types such as a plate electrode, a spherical adsorption electrode, a suspension electrode, a soft electrode and the like, wherein the plate electrode, the adsorption electrode and the suspension electrode are all rigid macro electrodes, and have the characteristics of simple structure and reusability. The soft electrode is an electrode that designs to the infant clinically, fix a fritter silver-colored silk screen on the adhesive plaster, or deposit one deck Ag-AgCl membrane on polyester film, compare in preceding several kinds of electrodes, the change of body surface curvature can be better complied with to the soft electrode, form good contact with skin, signal acquisition is effectual, it is little to remove the artefact, but present soft electrode receives the restriction of material, the flexuosity is little, also can not satisfy human changeable body surface structure, and the comfort level is relatively poor.
The dry electrode is an electrode which does not need the assistance of conductive paste when in use, and the electrode overcomes various problems brought by the use of the electrode paste: the operation is complicated, slight stimulation is generated to the skin, discomfort of a testee is brought, and the like. People use polyimide and silicon materials to prepare the body surface electrode of the probe structure, and the probe can pass through the stratum corneum during use, directly contacts with epidermal tissues, reduces the impedance brought by the stratum corneum, but the dry electrode can bring certain stabbing pain to a testee, can only be used as a short-term monitoring tool, and the two materials can not be stretched per se, and can not completely meet the requirement of the changeable body surface structure of a human body.
Disclosure of Invention
In view of the above, there is a need for a medical electrode patch having good flexibility and elasticity.
A medical electrode patch comprising: the flexible stretchable body surface electrode comprises a flexible substrate, an electrode unit, an electrode lead, a lead connection point and an insulating layer, wherein the electrode unit, the electrode lead and the lead connection point jointly form an electrode assembly, the flexible substrate comprises a first surface and a second surface, the electrode assembly is arranged on the first surface, the electrode unit is connected to the lead connection point through the electrode lead, the electrode unit is used for realizing the electric connection between the flexible stretchable body surface electrode and a target test position on the body surface of a tested person, the insulating layer is arranged on the first surface and covers the electrode lead, and the flexible substrate and the insulating layer are made of polydimethylsiloxane; and a protective film covering the electrode assembly without adhering thereto to protect the electrode assembly.
In one embodiment, the medical electrode patch comprises a medical breathable adhesive, and one surface of the medical breathable adhesive comprises an electrode attaching area and a protective film attaching area; the second surface of the flexible substrate is attached to the electrode attaching area, one part of the protective film is attached to the protective film attaching area, and the other part of the protective film covers the electrode assembly.
In one embodiment, the surface of the area of the flexible stretchable body surface electrode beside the electrode assembly is coated with rubber-type pressure-sensitive adhesive paste, one part of the protective film is attached to the medical electrode paste through the rubber-type pressure-sensitive adhesive paste, and the other part of the protective film covers the electrode assembly.
In one embodiment, the protective film is two pieces attached to both sides of the electrode assembly.
In one embodiment, the flexible stretchable body surface electrode is formed by a micro-electro-mechanical machining process.
Also provides a preparation method of the medical electrode paste.
A preparation method of a medical electrode paste comprises the following steps: providing a medical breathable adhesive tape, wherein one surface of the medical breathable adhesive tape comprises an electrode attaching area and a protective film attaching area; sticking a flexible stretchable body surface electrode on the surface of the electrode sticking area, and sticking a part of the protective film on the surface of the protective film sticking area to form a medical electrode paste; the flexible stretchable body surface electrode comprises a flexible substrate, an electrode unit, an electrode lead, a lead connection point and an insulating layer, wherein the electrode unit, the electrode lead and the lead connection point jointly form an electrode assembly, the flexible substrate comprises a first surface and a second surface, the electrode assembly is arranged on the first surface, the electrode unit is connected to the lead connection point through the electrode lead, the electrode unit is used for realizing the electric connection of the flexible stretchable body surface electrode and a target test position on the body surface of a tested person, the insulating layer is arranged on the first surface and covers the electrode lead, the flexible substrate and the insulating layer are made of polydimethylsiloxane, and the second surface of the flexible substrate is attached to the electrode attachment area; one part of the protective film is attached to the protective film attaching area, and the other part of the protective film covers the electrode assembly but is not adhered to the electrode assembly, so that the electrode assembly is protected.
In one embodiment, the protective film attaching areas are located on two sides of the electrode attaching area, and the two protective films are respectively attached to the surface of the electrode attaching area on one side.
Also provides another preparation method of the medical electrode paste.
A preparation method of a medical electrode paste comprises the following steps: providing a flexible stretchable body surface electrode, wherein the flexible stretchable body surface electrode comprises a flexible substrate, an electrode unit, an electrode lead, a lead connecting point and an insulating layer, the electrode unit, the electrode lead and the lead connecting point jointly form an electrode assembly, the electrode assembly is arranged on the flexible substrate, the electrode unit is connected to the lead connecting point through the electrode lead, the electrode unit is used for realizing the electric connection between the flexible stretchable body surface electrode and a target test position on the body surface of a testee, the insulating layer is arranged on the flexible substrate and covers the electrode lead, and the flexible substrate and the insulating layer are made of polydimethylsiloxane; the flexible stretchable body surface electrode further comprises a protective film attaching region positioned beside the electrode assembly; coating rubber type pressure-sensitive adhesive slurry on the surface of the protective film attaching area, and drying; attaching a protective film to the surface of the protective film attaching area; one part of the protective film is attached to the protective film attaching area, and the other part of the protective film covers the electrode assembly but is not adhered to the electrode assembly, so that the electrode assembly is protected.
In one embodiment, the protective film attaching areas are located on two sides of the electrode attaching area, and the two protective films are respectively attached to the surface of the electrode attaching area on one side.
Drawings
FIG. 1 is a schematic view showing the structure of a flexible stretchable body surface electrode in example 1;
FIG. 2 is a cross-sectional view taken along the dashed line 6 shown in FIG. 1;
FIG. 3 is a cross-sectional view taken along the dashed line 7 shown in FIG. 1;
FIG. 4 is a flowchart of a method for producing a medical electrode patch in example 1;
fig. 5A to 5E are schematic views showing the use of the medical electrode patch in example 1;
FIG. 6 is a flowchart of a method for producing a medical electrode patch in example 2;
fig. 7A to 7F are schematic views showing the use of the medical electrode patch in example 2.
Detailed Description
In order to make the objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below.
The invention provides a flexible stretchable body surface electrode. The electrode is mainly used for recording bioelectricity information on the surface of a human body or an animal body and applying electric stimulation, and is used for clinical diagnosis and research on laboratory animal models.
Example 1:
fig. 1 is a schematic structural diagram of a flexible stretchable body surface electrode in example 1, which includes a flexible substrate 1, an insulating layer 2, an electrode unit 3, an electrode lead 4 and a lead connection point 5. The electrode lead 4 electrically connects the electrode unit 3 and the lead connection point 5, and one electrode unit 3, one electrode lead 4 and one lead connection point 5 constitute one electrode assembly. The electrode assembly is disposed on the flexible substrate 1, and the insulating layer 2 is disposed on the flexible substrate 1 and covers the electrode leads 4. The electrode unit 3 is used for realizing the electric connection between the flexible stretchable body surface electrode and the target test position on the body surface of the tested person, and the lead connection point 5 is used for realizing the electric connection between the flexible stretchable body surface electrode and an external circuit.
Fig. 2 is a sectional view taken along a broken line 6 shown in fig. 1, and fig. 3 is a sectional view taken along a broken line 7 shown in fig. 1. In this embodiment, the electrode unit 3 and the lead connection point 5 are exposed to the outside, and the insulating layer 2 is not provided on the surface. The number of electrode units 3 is 4 and is distributed in a 2 x 2 matrix. It can be understood that the shape, size, spacing, number and arrangement of the electrode units 3 can be adjusted according to the requirements of practical application. The electrode lead 4 is sandwiched between the flexible substrate 1 and the insulating layer 2 to form a sandwich structure. The line width, pitch, and routing manner of the electrode lead 4 can be adjusted in consideration of the reasonableness of wiring. The shape, size, spacing and arrangement of the lead connection points 5 can be adjusted according to the requirements of practical application. The lead connection points 5 correspond to the electrode units 3 one to one, and the number of the lead connection points is the same. In the present embodiment, the lead connection points 5 are arranged in a 4 x 1 matrix.
The material of the flexible substrate 1 and the insulating layer 2 is polydimethylsiloxane (polydimethylsiloxane). The polydimethylsiloxane has good flexibility and deformation capability and good biocompatibility, and the flexible stretchable body surface electrode prepared by matching with a Micro Electro Mechanical System (MEMS) processing technology has good flexibility and elasticity, can form good conformal attachment with skin, and meets the variable body surface structure and deformation requirements of organisms. And the multi-channel high-spatial-resolution electrode is prepared by adopting a micro-electro-mechanical processing technology, so that the design of the multi-channel high-spatial-resolution electrode can be realized, and the processing precision and the spatial resolution of the minimum micron scale can be realized.
The medical electrode patch can be prepared by adopting the flexible stretchable body surface electrode, and fig. 4 is a flow chart of a preparation method of the medical electrode patch in example 1, and comprises the following steps:
and S110, preparing a piece of medical breathable adhesive tape.
A piece of medical breathable adhesive tape 8 (in this example, medical adhesive bandage) is prepared, as shown in fig. 5A. The surface of the medical breathable adhesive tape 8 is provided with glue, so that the medical breathable adhesive tape can be pasted.
And S120, cutting the adhesive plaster into a proper shape and size.
The medical gas permeable adhesive tape 8 is cut to a suitable shape and size as required by the shape and size of the flexible stretchable body surface electrode and the target (subject) test site, as shown in fig. 5B. It is understood that in other embodiments, the flexible stretchable body surface electrode and the medical gas permeable adhesive tape can be made in a uniform specification to meet the requirement of mass production in industry, so that the step S130 can be directly performed without cutting the adhesive tape.
And S130, attaching the flexible stretchable body surface electrode and the protective film to the surface of the adhesive tape.
The protective film can be pasted firstly, then the flexible stretchable body surface electrode can be pasted, and the flexible stretchable body surface electrode can be pasted firstly, then the protective film can be pasted. In this embodiment, the protective film is first attached.
And sticking a protective film 9 on the surface of the cut medical breathable adhesive tape 8 for standby, wherein the protective film 9 is divided into a left piece and a right piece. The left part of the left protective film 9 is attached to the medical breathable adhesive tape 8, and the right part of the left protective film is not attached to the medical breathable adhesive tape 8 but only covers the medical breathable adhesive tape 8. In a similar way, the right part of the right protective film 9 is attached to the medical breathable adhesive tape 8, and the left part of the right protective film is not attached to the medical breathable adhesive tape 8 but only covers the medical breathable adhesive tape 8. In this way, the two protective films 9 form an overlapping structure between the medical breathable adhesive tapes 8. It will be appreciated that, in the case of the medical breathable adhesive tape 8 having tackiness (adhesive) on the surface, the portion of the protective film 9 located in the middle of the medical breathable adhesive tape 8 may be stuck.
The protective film 9 on the medical breathable adhesive tape 8 is lifted from the middle part of the medical breathable adhesive tape 8, and the flexible stretchable body surface electrode is adhered to the middle part of the medical breathable adhesive tape 8, as shown in fig. 5C. Wherein the exposed parts of the electrode unit 3 and the lead connecting point 5 of the flexible stretchable body surface electrode face upwards to realize the electric connection with the target test position of the testee.
The arrangement mode of the left protective film and the right protective film is adopted, so that the flexible stretchable body surface electrode in the middle can be well protected, and the protective film can be conveniently lifted when in use. It is understood that in other embodiments, other protective film arrangements may be used, such as only one protective film.
After the steps are completed, the medical electrode paste is prepared. As shown in fig. 5C, the medical electrode patch includes a medical breathable adhesive tape 8, and one surface of the medical breathable adhesive tape 8 includes an electrode attachment region and a protective film attachment region. The surface of the flexible substrate 1 without the insulating layer 2 is attached to the electrode attaching area, one part of the protective film 9 is attached to the protective film attaching area, and the other part of the protective film covers the electrode assembly.
When in use, the protective film 9 is opened to expose the flexible stretchable body surface electrode in the middle. The wires 10 are connected to the lead connection points 5 and are fixed and encapsulated. The left and right protective films 9 on the medical breathable adhesive tape 8 are removed, and the flexible stretchable body surface electrode can be adhered to the target test position of the testee. The target test site in this embodiment is the elbow joint 11 of the human body.
Example 2:
the flexible stretchable body surface electrode in embodiment 2 has the same structure as that in embodiment 1, and therefore, the detailed description thereof is omitted. Fig. 6 is a flowchart of a method for manufacturing a medical electrode patch in example 2, including the steps of:
s210, cutting the flexible stretchable body surface electrode into a proper shape and size.
When the flexible stretchable body surface electrode is processed, enough space needs to be reserved on the polydimethylsiloxane film on the periphery of the electrode assembly, and then the peripheral polydimethylsiloxane film is cut into a proper shape and size according to the shape and size of the flexible stretchable body surface electrode and the requirement of a target (testee) test position. FIG. 7B is the flexible stretchable body surface electrode of FIG. 7A after being cut. It is understood that in other embodiments, the flexible stretchable body surface electrodes can be made in a uniform specification to meet the requirement of mass production in industry, so that the step S220 can be directly performed without cutting the flexible stretchable body surface electrodes.
And S220, coating rubber type pressure-sensitive adhesive paste on the protective film attaching area beside the electrode assembly, and drying.
The polydimethylsiloxane films (the flexible substrate 1 and the insulating layer 2) on both sides of the electrode assembly are used as protective film attaching areas 12 for attaching the protective film 9, and the protective film 9 is divided into a left sheet and a right sheet. The surface of the protective film attaching region 12 is coated with rubber type pressure sensitive adhesive paste and subjected to drying treatment for use.
And S230, attaching the protective film to the surface of the protective film attaching area.
Two pieces of protective films 9 are respectively attached to the surfaces of the electrode attaching regions 12 on one side, and the protective films 9 cover the electrode assembly but are not adhered to the electrode assembly. The rubber-based pressure sensitive adhesive is used as an adhesive to the body surface (and the protective film 9), and it is understood that in other embodiments, the rubber-based pressure sensitive adhesive may be replaced with an adhesive known in the art that can be used on a body surface.
After the steps are completed, the medical electrode paste is prepared. When in use, the protective film 9 is opened to expose the flexible stretchable body surface electrode in the middle. The wires 10 are connected to the lead connection points 5 and are fixed and encapsulated. The left and right protective films 9 on the medical breathable adhesive tape 8 are removed, and the flexible stretchable body surface electrode can be adhered to the target test position of the testee. The target test site in this embodiment is the upper arm muscle 13 of the human body.
Compared with the prior art, the invention has the following beneficial effects:
1) the flexible stretchable body surface electrode has good elastic performance, can still ensure good electric conduction under the condition of elastic deformation, and has wider application range compared with the body surface electrode in clinical application at present. The device can be used for the positions with relatively flat and small motion amplitude, such as the chest, the abdomen and the like, and can also be used for the joints with frequent and large motion, such as the elbows, the wrists, the knees and the like.
2) The polydimethylsiloxane film of the flexible stretchable body surface electrode and the medical breathable adhesive tape for fixing the electrode in the embodiment 1 have good waterproof performance, so that the medical electrode paste also has good waterproof performance. For the testee, the life is more convenient, and the limitation is little.
3) The flexible stretchable body surface electrode belongs to a dry electrode, does not need conductive paste, is more convenient to use, and simultaneously increases the comfort level of a patient.
4) The flexible stretchable body surface electrode has the characteristics of small volume, light weight and thin thickness, and has good waterproofness as mentioned in the point 2), so that the flexible stretchable body surface electrode can be worn for a long time and is suitable for long-term monitoring of certain body surface potential information.
5) The flexible stretchable body surface electrode provided by the invention can not cause damage or pressure to the skin of a testee and can not cause discomfort of the testee.
6) The flexible stretchable body surface electrode can realize the processing precision and the spatial resolution from the minimum to the micron scale, and the number of the electrodes in the electrode array can be increased according to the needs without increasing the additional manufacturing cost.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the present invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.
Claims (9)
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| CN201310440100.1A CN103462601B (en) | 2013-09-24 | 2013-09-24 | Electrode for medical service pastes and preparation method thereof |
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| CN201310440100.1A CN103462601B (en) | 2013-09-24 | 2013-09-24 | Electrode for medical service pastes and preparation method thereof |
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| CN103784136A (en) * | 2014-02-25 | 2014-05-14 | 薛运章 | Electrocardiogram precordial lead electrode plate set and preparation method thereof |
| CN104095628A (en) * | 2014-07-04 | 2014-10-15 | 李若斌 | Flexible medical electrode, medical electrode sheet, detecting instrument, treatment instrument and application |
| CN104224170A (en) * | 2014-09-15 | 2014-12-24 | 浙江大学 | Array type flexible surface electromyography electrode and preparation method thereof |
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| CN103784136B (en) * | 2014-02-25 | 2015-07-01 | 薛运章 | Electrocardiogram precordial lead electrode plate set and preparation method thereof |
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