CN110037792B - Preparation method of surgical electrode loop pad - Google Patents

Preparation method of surgical electrode loop pad Download PDF

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Publication number
CN110037792B
CN110037792B CN201910332036.2A CN201910332036A CN110037792B CN 110037792 B CN110037792 B CN 110037792B CN 201910332036 A CN201910332036 A CN 201910332036A CN 110037792 B CN110037792 B CN 110037792B
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film layer
tpu film
conductive cloth
surgical electrode
electrode circuit
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CN110037792A (en
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节云峰
张凡
谭志大
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Yingpaier (Chongqing) Medical Technology Co.,Ltd.
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Chongqing Yingpaier Medical Technology Co ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/12—Layered products comprising a layer of synthetic resin next to a fibrous or filamentary layer
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/40—Layered products comprising a layer of synthetic resin comprising polyurethanes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B3/00—Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar form; Layered products having particular features of form
    • B32B3/26—Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar form; Layered products having particular features of form characterised by a particular shape of the outline of the cross-section of a continuous layer; characterised by a layer with cavities or internal voids ; characterised by an apertured layer
    • B32B3/266—Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar form; Layered products having particular features of form characterised by a particular shape of the outline of the cross-section of a continuous layer; characterised by a layer with cavities or internal voids ; characterised by an apertured layer characterised by an apertured layer, the apertures going through the whole thickness of the layer, e.g. expanded metal, perforated layer, slit layer regular cells B32B3/12
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B37/00—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding
    • B32B37/06—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by the heating method
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B37/00—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding
    • B32B37/10—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by the pressing technique, e.g. using action of vacuum or fluid pressure
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B37/00—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding
    • B32B37/12—Methods or apparatus for laminating, e.g. by curing or by ultrasonic bonding characterised by using adhesives
    • B32B37/1284—Application of adhesive
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B7/00—Layered products characterised by the relation between layers; Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties; Layered products characterised by the interconnection of layers
    • B32B7/04—Interconnection of layers
    • B32B7/12—Interconnection of layers using interposed adhesives or interposed materials with bonding properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00059—Material properties
    • A61B2018/00071—Electrical conductivity
    • A61B2018/00083—Electrical conductivity low, i.e. electrically insulating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/147—Electrodes transferring energy by capacitive coupling, i.e. with a dielectricum between electrode and target tissue
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/20—Properties of the layers or laminate having particular electrical or magnetic properties, e.g. piezoelectric
    • B32B2307/206—Insulating

Abstract

The invention relates to a preparation method of an operation electrode loop pad. It comprises the following steps in sequence: (1) cutting; (2) gluing; (3) attaching the fabric; (4) hot pressing; (5) and assembling a capacitor plate lead-out wire and the like. The preparation method has high yield, and can ensure excellent quality of the operation electrode loop pad product.

Description

Preparation method of surgical electrode loop pad
Technical Field
The invention relates to the field of medical instruments, in particular to a preparation method of an operation electrode loop pad.
Background
At present, when a high-frequency scalpel is used for carrying out operation on a patient, the mode of forming a high-frequency current loop by the scalpel through a human body and a high-frequency generator of the scalpel is mainly realized as follows: one is a conventional negative plate type, and the other is a capacitive type circuit pad type.
Traditional negative plate mode, its principle is through skin direct contact conduction current, need handle with the skin of negative plate contact site on the patient health earlier in using usually, laminates the negative plate whole on patient's health again to it has great area of contact to guarantee negative plate and human skin. The method has the following problems that the treatment operation on the skin of the patient body easily affects the conductivity of the negative plate, thereby causing electric burns and burns; when the operation is carried out for a long time, the negative plate is attached to the skin of a human body for a long time, so that the patient feels uncomfortable; local current is easily concentrated, and local scald is caused.
In view of the above problems, a non-contact capacitive surgical electrode circuit pad designed according to the capacitive coupling principle has been proposed, and the structure of the non-contact capacitive surgical electrode circuit pad is shown in fig. 1, which includes a capacitor plate lead wire 9 and an electrode circuit pad main body 8, wherein the electrode circuit pad main body 8 is mainly formed by combining a conductive cloth and two gel layers respectively distributed on the upper and lower surfaces of the conductive cloth, and the gel layers are used as insulating media. The action principle is as follows: after the operation electrode loop pad formed by wrapping an internal conductive cloth (conductor) by an external insulating medium film layer and a patient (conductor) form a capacitor to be electrified, the patient and the two poles of an internal electric plate form a potential difference, an electric field exists between the conductors with different potentials, and due to energy injection, the electric field between the conductors changes, and the current passes through the capacitor in a field passing mode. Most of the existing preparation methods of non-contact surgical electrode circuit pads are to respectively pour polymer gel on two surfaces of a capacitor plate for encapsulation. Such a preparation method has the following problems in specific applications: 1. the operation electrode loop pad product has more bubbles and is easy to wrinkle; 2. the product stability is poor, and the conductive cloth is unstable in the gel and is easy to strip; 3. the yield is low; 4. the thickness of the gel layer in the product is not easy to control and easy to wrinkle; 5. conductive cloth is not easy to be accurately positioned in the gel, and the like.
Disclosure of Invention
The invention aims to provide a preparation method of an operation electrode loop pad, which has high yield and can ensure that the operation electrode loop pad product has excellent quality.
In order to achieve the purpose, the invention provides the following technical scheme:
a preparation method of a surgical electrode loop pad is characterized by sequentially comprising the following steps:
(1) cutting out
Cutting an upper TPU film layer, a lower TPU film layer and conductive cloth according to a drawing, and respectively making positioning holes at corresponding positions on the upper TPU film layer, the lower TPU film layer and the conductive cloth;
(2) glue spreading
Respectively coating hot melt adhesive films with the thickness of 0.015mm and heated to 80-100 ℃ on the lower surface of the upper TPU film layer, the upper surface of the lower TPU film layer and the upper and lower surfaces of the conductive cloth;
(3) laminated fabric
Sequentially placing the lower TPU film layer, the conductive cloth and the upper TPU film layer into a die, ensuring that the periphery of the conductive cloth is respectively equidistant to the outer edge of the lower TPU film layer and the outer edge of the upper TPU film layer during placement, and fitting the three layers of fabrics together according to the positions of the positioning holes;
(4) hot pressing
Putting the three-layer composite fabric adhered together on a vacuum hot-pressing forming machine, uniformly heating from room temperature to 60 ℃ within 5 minutes, preserving heat for 1 minute, synchronously carrying out hot pressing and negative pressure pumping, then cooling to room temperature, then uniformly heating to 70 ℃ within 5 minutes, preserving heat for 2 minutes, synchronously carrying out hot pressing and negative pressure pumping, then cooling to room temperature, finally uniformly heating to 80 ℃ within 5 minutes, preserving heat for 3 minutes, synchronously carrying out hot pressing and negative pressure pumping, then slowly cooling to room temperature, and taking out;
(5) lead-out wire for assembling capacitor plate
And fixedly connecting the outgoing line of the capacitor plate to the positioning hole on the conductive cloth.
As a further optimization, the thicknesses of the upper TPU film layer and the lower TPU film layer are both 0.2-0.5 mm; the thickness of the conductive cloth is 0.1 mm. The electric capacity of the operation electrode loop pad can be greatly improved by setting the thicknesses of the TPU film layers and the conductive cloth layers at the upper part and the lower part, the output power of the high-frequency electrotome is reduced, and the weight is light.
Calculation formula of capacitance:
Figure BDA0002038017750000031
wherein d represents the thickness of the TPU film layer.
As a further optimization, the design sizes of the upper TPU film layer and the lower TPU film layer are the same and are 900mm multiplied by 500 mm; the design size of the conductive cloth is 880mm multiplied by 480 mm.
As a further optimization, the cutting in the step (1) is specifically completed by adopting a cutting die according to the designed size.
As a further optimization, the gluing in the step (2) is completed by an automatic gluing machine.
As a further optimization, the hot melt adhesive film is selected from H3T series hot melt adhesive films produced by Suzhou plastic polymer material science and technology limited, and the main component of the hot melt adhesive film is modified polyurethane.
As a further optimization, the negative pressure is particularly the negative pressure until the vacuum degree is 102～103Pa。
As a further optimization, after the hot pressing operation in the step (4) is completed, a beautification trimming operation is performed before the step (5). These aesthetic trims are mainly trimming of burrs, protrusions, etc. formed during the hot pressing.
The invention has the following beneficial effects:
the invention provides a preparation method of an operation electrode loop pad, which is characterized in that TPU (thermoplastic polyurethane) films are coated on the upper surface and the lower surface of a conductive cloth serving as a capacitor plate in a hot-pressing compounding manner to serve as an insulating medium, so that the operation electrode loop pad consisting of the conductive cloth and the TPU films is prepared, the yield is high (the yield is over 90%), the TPU films and the conductive cloth adopt a specific hot-pressing compounding process, the conductive cloth is stably combined in the insulating medium and is not easy to peel, the peel strength index (the peel strength is more than 4.2N/cm, the peel test refers to the national standard GB8808), and the stability of the obtained product is good; the conductive cloth is accurately positioned in the gel; the hot pressing process is uniformly heated, so that the product can be prevented from wrinkling; the prepared operation electrode loop pad product has no bubbles and is not easy to wrinkle in use; the thickness of the product is easy to control and is not easy to wrinkle.
Drawings
Fig. 1 is a schematic perspective view of a surgical electrode circuit pad in the prior art.
Fig. 2 is a schematic structural diagram of the surgical electrode circuit pad according to embodiment 1 of the present invention.
Fig. 3 is an enlarged view of a portion of the surgical electrode circuit pad of fig. 2.
Fig. 4 is a schematic view of the positioning holes on the upper TPU film layer and the lower TPU film layer in the surgical electrode circuit pad of fig. 3.
Fig. 5 is a schematic structural diagram of positioning holes on the conductive cloth in the surgical electrode circuit pad of fig. 3.
Detailed Description
The invention is further described in the following examples, which are not intended to limit the invention thereto.
Example 1
A preparation method of a surgical electrode loop pad sequentially comprises the following steps:
(1) cutting out
Cutting an upper TPU film layer, a lower TPU film layer and conductive cloth with proper sizes by adopting a cutting die according to a drawing, respectively forming positioning holes A, B, C, D, E and F at corresponding positions on the upper TPU film layer and the lower TPU film layer, and forming positioning holes A, C, D, J and H at corresponding positions on the conductive cloth; wherein the thicknesses of the upper TPU film layer and the lower TPU film layer are both 0.3mm, and the thickness of the conductive cloth is 0.1 mm; the design sizes of the upper TPU film layer and the lower TPU film layer are the same and are 900mm multiplied by 500 mm; the design size of the conductive cloth is 880mm multiplied by 480 mm;
(2) glue spreading
Respectively coating hot melt adhesive films with the thickness of 0.015mm and heated to 90 ℃ on the lower surface of the upper TPU film layer, the upper surface of the lower TPU film layer and the upper and lower surfaces of the conductive cloth by using an automatic glue spreader; wherein the hot melt adhesive film is H3T series hot melt adhesive film produced by Suzhou plastic polymer material science and technology limited company, and the main component of the hot melt adhesive film is modified polyurethane; the model of the automatic glue spreader is as follows: SJ-304 full-automatic micro-gumming machine, manufacturer: shanghai good mechanical Equipment, Inc.;
(3) laminated fabric
Accurately designing and manufacturing an aluminum alloy die according to the sizes of the upper TPU film layer, the lower TPU film layer and the conductive cloth, and also arranging a positioning hole on the die according to the structural design of an operation electrode loop pad product to ensure that the three layers of fabrics are placed according to the design, then sequentially placing the lower TPU film layer, the conductive cloth and the upper TPU film layer into the die, and ensuring that the periphery of the conductive cloth is respectively equidistant to the outer edge of the lower TPU film layer and the outer edge of the upper TPU film layer when placing, and attaching the three layers of fabrics together according to the position of the positioning hole;
(4) hot pressing
The three layers of composite fabrics which are adhered together are put on a vacuum hot-pressing forming machine, and are uniformly heated from room temperature to 60 ℃ within 5 minutesKeeping the temperature for 1 minute and synchronously carrying out hot pressing and negative pressure pumping till the vacuum degree is 103Pa, cooling to room temperature, uniformly heating to 70 deg.C within 5 min, holding for 2 min, and synchronously hot pressing and vacuum pumping to vacuum degree of 103Pa, cooling to room temperature, uniformly heating to 80 deg.C within 5 min, keeping the temperature for 3 min, and synchronously hot-pressing and vacuum-pumping to vacuum degree of 103Pa, then slowly cooling to room temperature, and taking out; wherein, the model of the vacuum hot-pressing forming machine is as follows: ZXB-200, manufacturer: youthou mechanical manufacturing Co., Ltd, Yunju;
(5) beautified pruning
Trim burrs, protrusions, etc. formed during the hot pressing.
(6) Lead-out wire for assembling capacitor plate
And riveting two wires at one end of the capacitor plate lead-out wire to the positions J and H on the conductive cloth through copper rivets respectively, and then adhering the two wires on the capacitor plate lead-out wire together by adopting conventional hot melt adhesive.
The preparation and measurement are carried out for a plurality of times according to the steps shown in the example, the yield of the operation electrode circuit pad product in the example is more than 90%, and the yield is high; in the obtained operation electrode loop pad product, the conductive cloth is stably combined in the insulating medium and is not easy to peel, the peel strength is more than 4.2N/cm (the peel test is referred to the national standard GB8808), and the obtained product has good stability; the conductive cloth is accurately positioned in the gel; the hot pressing process is uniformly heated, the product has no folds and no bubbles, and the folds are not easy to occur in use; the thickness of the product is easy to control and is not easy to wrinkle.

Claims (7)

1. A preparation method of a surgical electrode loop pad is characterized by sequentially comprising the following steps:
(1) cutting out
Cutting an upper TPU film layer, a lower TPU film layer and conductive cloth according to a drawing, and respectively making positioning holes at corresponding positions on the upper TPU film layer, the lower TPU film layer and the conductive cloth;
(2) glue spreading
Respectively coating hot melt adhesive films on the lower surface of the upper TPU film layer, the upper surface of the lower TPU film layer and the upper and lower surfaces of the conductive cloth;
(3) laminated fabric
Sequentially placing the lower TPU film layer, the conductive cloth and the upper TPU film layer into a die, ensuring that the periphery of the conductive cloth is respectively equidistant to the outer edge of the lower TPU film layer and the outer edge of the upper TPU film layer during placement, and fitting the three layers of fabrics together according to the positions of the positioning holes;
(4) hot pressing
Putting the three-layer composite fabric adhered together on a vacuum hot-pressing forming machine, uniformly heating from room temperature to 60 ℃ within 5 minutes, preserving heat for 1 minute, synchronously carrying out hot pressing and negative pressure pumping, then cooling to room temperature, then uniformly heating to 70 ℃ within 5 minutes, preserving heat for 2 minutes, synchronously carrying out hot pressing and negative pressure pumping, then cooling to room temperature, finally uniformly heating to 80 ℃ within 5 minutes, preserving heat for 3 minutes, synchronously carrying out hot pressing and negative pressure pumping, then slowly cooling to room temperature, and taking out;
(5) lead-out wire for assembling capacitor plate
Fixedly connecting the outgoing line of the capacitor plate to a positioning hole on the conductive cloth;
the negative pressure is specifically the negative pressure until the vacuum degree is 102～103Pa。
2. The method of making a surgical electrode circuit pad of claim 1, wherein: the thicknesses of the upper TPU film layer and the lower TPU film layer are both 0.2-0.5 mm; the thickness of the conductive cloth is 0.1 mm.
3. A method of preparing a surgical electrode circuit pad as claimed in claim 1 or 2, wherein: the design sizes of the upper TPU film layer and the lower TPU film layer are 900mm multiplied by 500 mm; the design size of the conductive cloth is 880mm multiplied by 480 mm.
4. The method of making a surgical electrode circuit pad of claim 1, wherein: and (2) finishing the cutting in the step (1) according to the design size by adopting a cutting die.
5. The method of making a surgical electrode circuit pad of claim 1, wherein: and (3) gluing in the step (2) by adopting an automatic gluing machine.
6. The method of making a surgical electrode circuit pad of claim 1, wherein: the hot melt adhesive film is H3T series hot melt adhesive film produced by Suzhou plastic polymer material science and technology limited.
7. The method of making a surgical electrode circuit pad of claim 1, wherein: and (5) after the hot pressing operation in the step (4) is finished, performing beautification trimming operation before the step (5).
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US5713128A (en) * 1996-02-16 1998-02-03 Valleylab Inc Electrosurgical pad apparatus and method of manufacture
US8021360B2 (en) * 2007-04-03 2011-09-20 Tyco Healthcare Group Lp System and method for providing even heat distribution and cooling return pads
US8080007B2 (en) * 2007-05-07 2011-12-20 Tyco Healthcare Group Lp Capacitive electrosurgical return pad with contact quality monitoring
US8876812B2 (en) * 2009-02-26 2014-11-04 Megadyne Medical Products, Inc. Self-limiting electrosurgical return electrode with pressure sore reduction and heating capabilities
CN107456275A (en) * 2017-08-25 2017-12-12 奥克兰高分子医用材料(天津)有限公司 Novel operation electrode loop pad and preparation method thereof

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