BIO DEGRADABLE MEDICAL ELECTRODE DEVICE AND CONSTRUCTION METHOD
A) TECHNICAL FIELD
[0001] The present invention generally relates to electrode devices and more particularly to bio-degradable, environmental friendly medical electrode devices and its construction method using naturally available bio-degradable resources and materials such as leaf sheath of Areca Catechu Linn palm leaf plates or plastic made from starch based plastic. The present invention more particularly relates to a disposable, environment friendly skin conducting electrode and various electrode connector assemblies that are attached to a patient and used as an electrical signal sensing medical electrical apparatus, an electrical energy transmitting medical electrode, return electrode used in electro surgery, an active electrode for applying an electric current to a portion of a patient's body etc.
B) BACKGROUND OF THE INVENTION
0002] Generally the various physiological parameters of an individual are measured using several monitors known as, "vital sign parameter bed side monitor" or " vital sign monitoring systems", to measure heart rate level, blood pressure, artery pressure etc. The one of the important vital signs measured by healthcare providers is electrocardiography (ECG).
[3] The electrocardiography (ECG) device contains three or five or ten wires that are connected to various parts of the body and to a front-end amplifier. The bioelectric signals generated on the body will be picked up through the wires by these leads. The bioelectric signals generated by heart are very weak at the surface level of the body and have a low amplitude level. Moreover the surface of the skin is less conductive than the core of the body because of "stratum corneum" which is outer skin surface. So a properly designed medical electrode is essential to transmit the ECG signals from the skin to the ECG system machine without significant deterioration.
[4] A properly designed medical electrode contains an electrolyte, for example: silver chloride, which helps to conduct the signal from the skin to a lead wire without any resistive drop. The electrode should also contain
glycerol to retain the moisture, anti fungal & microbial agents, fungicides, bacteriacides, hypo allergic based adhesives that holds the electrode. The desired characteristics required to maintain the efficiency of a medical electrode are as follows. The materials used in the electrode do not add any noise to the ECG or ICVG signal The resistance /impedance ate low over the desired frequency range and over the longer period of use. The electrode material sticks to body surface easily and efficiendy without causing any inconvenience to the patient and the electrode does not peel off during the patient movement. The electrodes have water-proof and sweat-proof characteristics. The electrodes may have the capacity to withstand the weight of the cable leads and provide safety and comfort to a patient. The electrodes could be disposed in an environmentally friendly way without generating any nosocomial (hospital acquired syndrome) risk, when the electrode is used on a patient having any contagious decease like dengue, SARS etc. The electrode may be disposed and degraded biologically so that the used electrode is disposed after every use in an environmental friendly manner and the electrode is degraded in a biological manner on incineration or in burial to the earth, without generating any adverse effect on the environment
[5] Some of the medical electrodes should be transparent for X-rays & MRI signals so that the image of the internal organ of the patient may not be obstructed by the image of the electrodes during the display and the examination of the X-ray or MRI image. The electrodes should be made of the material which is available in plenty and supplied stably throughout the year at a cheaper cost
[6] The US Patent 6,847,836 discloses an emergency ECG electrode chest pad preferably made of a flexible, breathable or porous material known in the art, such as cotton, polyester or, most preferably, foam, etc., that are radiologically transparent to x-rays and other diagnostic procedures, like ultrasound imaging technique and magnetic resonance imaging (MRI) technique, etc. An adhesive is applied on the reverse side of the pad.
0007] The US Patent 6,775,566 discloses an electrode structure and heart rate measuring arrangement for measuring an ECG signal on the skin of a person's chest. The electrode structure comprises a band-like component that is fixed with the skin of the person's chest and that is made of soft and" flexible material which foUows the skin closely. The inner surface of the electrode structure has an adhesive surface for attaching the electrode structure on the skin of the person's chest.
[0008] The US patent 6,560,473 discloses a disposable ECG chest electrode template with built-in defibrillation electrodes having a location tab so that the template can be easily, quickly and correcdy placed on the patient's chest during emergency situations.
[9] Thus none of the currently available medical electrodes could not meet the requirements of an ideal environmental friendly bio~degradable electrode for medical devices.
Hence, there is a need to develop an economical, cheap, easily disposable, environment friendly and bio-degradable electrode using the naturally available bio-degradable resources.
C) OBJECT OF THE INVENTION
[11] The primary object of this invention is to develop a medical electrode using naturally available bio degradable resources and materials.
[12] Another object of this invention is to develop a medical electrode using materials and resources so that the medical electrodes may be disposed in an environmentally friendly manner and may be degraded biologically.
[13] Yet another object of the present invention is to develop a cheap disposable medical electrode that may be disposed after each use.
[14] Yet another object of the present invention is to produce medical electrodes cheaply and reHably.
[15] Yet another object of the present invention is to develop a sheet assembly for dispensing medical electrodes so that the medical personnel rnay be able to fix the respective electrodes at the required locations easily and efficiendy without generation of any error in fixing the electrodes.
[0016] These and other objects and advantages of the present invention will become readily apparent from the following detailed description taken in conjunction with the accompanying drawings.
as plastic made from starch material, instead of Styro-foam / URETHANE PLASTIC / FOAM (petroleum /hydrocarbon based) that are used as insulator in the currendy available electrodes in the market. A gum such as a plant based gum is used for sticking an electrode to the body of a human being at a desired location. One such preferred gum is Gum Karaya is the dried exudates of the Sterculia Urens tree of the Sterculiaceae family.
[0020] According to one preferred embodiment of the present invention, a press stud type basic medical electrode contains a metaUic press smd connected to an electrode assembly mounted on a plastic tape or release liner. The electrode assembly has an electrolyte layer sandwiched between two adhesive layers. An insulating tape is arranged at the uppermost layer of the electrode assembly. The press stud is provided to establish an electrical connection between the electrode and the patient lead interface cable. A plastic tape or release liner is provided at the lowermost layer of the electrode assembly. The insulator plate in the electrode assembly is made up of bio degradable material like the leaf sheath of Areca Catechu Linn Palm, etc. The upper adhesive layer is formed by injecting the adhesive particles through an injection machine. The electrolyte layer contains hydro gel or starch loaded with conductive particles. The lower adhesive layer is an
conductive adhesive layer formed by using die KARAYA gel or gum ARABICA or gum gutti or starch based gum.
[21] According to another embodiment of the present invention, the bio plate is made up of bio -degradable plastic such as plastic made from starch material, instead of Styro-foam / URETHANE PLASTIC / FOAM (petroleum /hydrocarbon based) that are used as insulator in the currendy available electrodes in the market The biodegradable plastic is a plastic made from the lactic acid, which is obtained by the fermentation process of corn-starch material. The bio -degradable plastic is a starch based plasdc and is a non-petroleum based plastic obtained from starch recovered from the com, wheat or potatoes so that the insulator may be disposed off after each use in an environmentally friendly manner. In the soil or water, the disposed or waste plastic is converted into water and carbon dioxide by the microbes and is absorbed by the green plants during a photosynthesis process to generate a starch again. Thus the starch based plastic is naturally recyclable.
[22] According to another embodiment of the present invention, a circular electrode with a magnetic contact is provided instead of the conductive stud. The electrode assembly has a lower assembly and an upper
assembly. The lower electrode assembly has an insulating layer arranged over a steel plate installed with a central conductor. An upper electrode assembly connected with the lower electrode assembly includes a dome contact which is coupled to a doughnut shaped permanent magnet. The dome contact has a central conductive lead which is made to engage with the central conductive part in the lower electrode assembly, when the dome contact is pressed during the mating of the lower and the upper electrode assemblies. When both the electrode assemblies are coupled together, the permanent magnet attracts the steel plate and the central conductive parts of both the electrode assemblies are made to contact each other to provide a strong electrical connection to transmit the measurement signals to a monitor interface, even when there is a vibration or motion.
[0023] According to another embodiment of the present invention, a medical electrode manufacturing method is disclosed. A special soft grade Areca Catechu Linn palm leaf sheaths are selected and used as an electrode insulator. The special soft grade Areca catechu Linn palm is formed by removing the outer surface of naturally available palm leaf sheath by steam heating the palm leaf sheaths and pressing the heat treated palm leaf sheaths using special machineries. The Palm shed leaf sheaths are first carefully sorted and then thoroughly washed. The machine-able portion is retained and mechanically pressed in a pre-heated form/dye. A final trimming process is executed to provide a final finish to the products. No chemicals, resins, dyes, strengthening agents and synthetic materials of any kind are used. in the entire manufacturing process. A specialized baking & sterilization processes are performed to ensure that the plates are totally germ free, hygienic, and suitable for using as food grade or medical grade for external application.
[0024] The pre-treated and processed areca palm leaf sheaths are cut into the flexible, dimensionaUy stable nonconductive substrates of desired sizes. In order to change the shape of the electrode to that of a body surface, the cut substrates are pressed using a pressing & stamping equipment. The substrate is fixed on a base plate. A shaft is arranged above the base plate and is moved vertically. A metaUic plate is fixed to the shaft to move the plate to press the substrate mounted on the base plate by moving the shaft downwardly, so that the substrate is compressed to remove the water and the trapped air from the substrate to increase the density of the substrate. At the same time, an electrode outline in oval/rectangular shape is formed on the substrate using a punch, so that the electrode portion may easily be separated from the compressed substrate. The compressed substrate is drilled. The holes are formed on the centre of the electrode using a drilling bit. The substrate thus formed is further cleaned using forced /pressurised air /fumigation gas or any other sterilizing gases to obtain a substrate which is free from burrs and fine dust particles
[25] During the next stage of manufacturing, the press stud connector p'arts are fixed from the top and the bottom of the electrode. The automatic electrode and adhesive dispensing machines such as syringes are automatically moved forward to dispense preset amount of hydro gel in to the center pit region and the adhesive in to outer peripheral area of the drilled substrate. The electrode is oriented vertically until the hydro gel and the adhesive are converted in to gel form. Then the press stud parts will be coated with silver-chloride so that there will not be galvanic voltage build-up between the gel and the metallic stud. In one embodiment of the invention, magnetic connectors are used instead of press studs.
[26] According to one embodiment of the present invention, a cup type medical electrode which may be used for long term monitoring by adding the ECG gel in intervals, has an outer insulation cup made from either Areca Catechu Linn Pakn leaf or bio degradable plastic. A metallic press stud plug is inserted into the cup type structure and fixed. A disc is attached to the bottom of the stud and is coated with silver chloride /oxidized to reduce the galvanic batrier between a conductive gel and the metallic press stud.
[27] A sponge impregnated with solid gel is provided on a conductive substrate arranged below the press stud. A nonconductive moisture impermeable barrier layer including an acryUc plastic or the like is applied over the conductive surface layer on the substrate. An adhesive ring is formed at the bottom of the cup like structure. Moreover, the sponge impregnated with solid gel is installed between the paste and a label to prevent the paste from oozing towards the side surface of the label. Therefore, the paste does not ooze out during storage of a bio-electrode. The inner lining of the cup like structure may be coated with silver paint.
[28] At least two holes are provided at the mutually opposite sides of the outer insulation cup in one embodiment to inject EGG gel into the sponge to carry out continuous monitoring process or when the medical electrode is reused. When a doctor requires a very long term monitoring of the patient, then these type of electrodes are used to monitor the patient continuously. During the long term monitoring process, the EGG gel will dry up during the course of monitoring and the replenishment of the EGG gel is required to carryout the monitoring operation continuously without a break. A standard syringe may be used to inject the ECG gel into the sponge. The ECG gel will be injected into the electrode forcefully through one hole so that the used gel will be forcefully ejected out through another hole. Thus the reading the gel may be refilled and the long term monitoring may be achieved continuously without stopping the monitoring process for refilling the reading gel.
[0029] According to another embodiment of the present invention, a disposable cup type medical electrode is provided with a cup structure formed using the bio degradable material like Areca Catechu Linn Palm leaf or from a bio-degradable plastic such as plastic made from starch based resin material. The biodegradable plastic is a plastic made from the lactic acid, which is obtained by the fermentation process of corn-starch material. The bio -degradable plastic is a starch based plastic and is a non-petroleum based plastic obtained from starch recovered from the com, wheat or potatoes so that the insulator may be disposed off after each use in an environmentally friendly manner. In the soil or water, the disposed or waste plastic is converted into water and carbon dioxide by the microbes and is absorbed by the green plants during a photosynthesis process to generate a starch again. Thus the starch based plastic is naturally recyclable.
[30] According to another embodiment of the present invention, a reusable type medical electrode is provided. A cup type medical electrode may be reused or be used for long term monitoring by adding the ECG gel in intervals, has an outer insulation cup made from either Areca Catechu Linn Palm leaf or bio degradable plastic. A metallic press stud plug is inserted into the cup type structure and fixed. A disc is attached to the bottom of the stud and is coated with silver chloride /oxidized to reduce the galvanic barrier between a conductive gel and the metallic press stud.
[31] A sponge impregnated with solid gel is provided on a conductive substrate arranged below the press stud. A nonconductive moisture impermeable barrier layer including an acrylic plastic or the like is applied over the conductive surface layer on the substrate. An adhesive ring is formed at the bottom of the cup like structure. Moreover, the sponge impregnated with solid gel is installed between the paste and a label to prevent the paste from oozing towards the side surface of the label. Therefore, the paste does not ooze out during storage of a bio-electrode. The inner lining of the cup like structure may be coated with silver paint.
[0032] At least two holes are provided at the mutually opposite sides of the outer insulation cup in one embodiment to inject ECG gel into the sponge to carry out continuous monitoring process or when the medical electrode is reused. When a doctor requires a very long term monitoring of the patient, then these type of electrodes are used to monitor the patient continuously. During the long term monitoring process, the ECG gel will dry up during the course of monitoring and the replenishment of the ECG gel is required to carryout the monitoring operation continuously without a break. A standard syringe may be used to inject the ECG gel into the sponge. The ECG gel will be injected into the electrode forcefully through one hole so that the used gel will be forcefully ejected out through another hole. Thus the reading the gel may be refilled and the long term monitoring may be achieved continuously without stopping the monitoring process for refilling the reading gel.
0033] The disposable cup type medical electrode is provided with a cup structure formed using the bio degradable material like Areca Catechu Linn Palm leaf or from a bio-degradable plastic such as plastic made from starch based resin material. The biodegradable plastic is a plastic made from the lactic acid, which is obtained by the fermentation process of corn-starch material. The bio -degradable plastic is a starch based plastic and is a non- petroleum based plastic obtained from starch recovered from the corn, wheat or potatoes so that the insulator may be disposed off after each use in an environmentally friendly manner. In the soil or water, the disposed or waste plastic is converted into water and carbon dioxide by the microbes and is absorbed by the green plants during a photosynthesis process to generate a starch again. Thus the starch based plastic is naturally recyclable.
[34] According to another embodiment of the present invention, a patient plate for a diathermy device is provided. The patient plate has a metal foil secured to one surface of insulating material such as leaf plate made from Areca Catechu Linn Palm leaf or from a bio-degradable plastic such as plastic made from starch based resin material.
[35] According to another embodiment of the present invention, an assembly for dispensing electrodes used in the "impedance cardio vasograph" commercially known as "ICVG machine" is provided. The assembly has several electrodes mounted on a carrier sheet made up of leaf plate formed from areca palm leaf or a starch based plastic material. A pull strip is releasably mounted on the carrier sheet to cover the tabs of the electrodes so that the electrodes are successively exposed as the pull strip is nnlled iinwardlv. The electrode disoensin^ assemblv has a carrier sheet
provided with at least two generally parallel and longitudinal tear lines so that the tear lines are extended along the carrier sheet. The carrier sheet is made up of an Areca catechu Linn Palm or starch based plastic card. Several electrodes are mounted in multiple rows in parallel on the bio-degradable carrier sheet over the tear lines. The electrodes are oriented in such a manner that the respective tabs of the electrodes are extended away from the centre of the carrier sheet and the electrodes are successively exposed as the carrier sheet is torn along the tear lines to facilitate easy access to the tabs of electrodes. Alternatively a pull strip is releaseably mounted on the carrier sheet made up of a leaf plate formed from areca palm leaf or a starch based plastic material to cover the electrodes so that the electrodes arranged in the multiple rows are successively exposed, as the removable pull strip is pulled upwardly from the carrier sheet to facilitate access to the tabs of the electrodes. The electrodes released from a location indicating an organ from the dispenser sheet are attached to the location of the respective organ in the human body.
[0036] The leads of the patient cable are marked with different colors The usage of such colored cable leads and colored electrodes helps a care-giver to connect the leads of the patient cable with different colors to the
respective electrodes by matching the colors of the electrode with that of the cable leads.
[37] According to another embodiment of the present invention, a clamp type medical electrode is provided. The clamp type electrode for an electrocardiograph includes a pair of clamping jaws having concave surfaces that are arranged opposite to each other. An electrode formed in a metal plate shape is attached to the inner surface of the upper clamping jaw. The two jaws are opened and closed relative to each other using a tension adjustable leaf spring. The tension adjustable spring applies a required clamping force to the clamping jaws based on the thickness of the limb to which the electrode is to be attached, so that a patient undergoing electrocardiographic diagnosis will not experience any discomfort. By adjusting the tension of the circular spring part based on the thickness of the limb, a clamp type electrode is attached to a limb, such as the wrist or ankle of a human body.
The two jaws are manufacmred from Areca Catechu Linn palm leaf plates. For a true biodegradable electrode, the spring may be manufactured using plant based stems after bending the stems in the required shape. The thetal plate type electrode provided at the inner concave surface may be
made up of sintered porous metal plate which may hold the gel for longer period of time. The metal plate is used to acquire ECG signals from the wrist or ankle of a human body. The metal plate may be manufactured from brass or AS316L stainless steel plate. The lower clamping jaw is coated with silver chloride layer to increase the signal fidelity. A connecting terminal is screwed to the metal plate to couple the electrode to the ECG patient lead. The connecting terminal has a hole to receive a banana plug from a patient interface cable. The electrodes are need to be identified by their color. The commonly used colors are RED, YELLOW, BLACK and GREEN. Since the areca plate does not have these colors, the naturally available/plant based colors may be applied on the outer surface of the upper clamping jaw. The electrodes are used as follows. The two edges of the circular spring clamp are pressed so that the two jaws are opened to receive a desired limb. The ECG gel is applied to the lower clamp jaw. After bringing the electrode over desired location, the edges of the spring clamp are released.
[0039] According to another embodiment of this invention, a disposable skin conducting electrode assembly is provided. The electrode assembly contains an electrolyte pad, an electrode and an adhesive pad made from areca nut palm leaf.
0040] According to another embodiment of this invention, an EEG head cap made up of areca palm leaf is provided.
[0041] The electrodes of the present invention can be used in a wide variety of fields including medical electrodes. The examples of such electrodes are sensing electrodes used in electro-cardiogram (ECG), electro oculogram (EOG), electro gastro gram (EGG), surface electro myogram (EMG), electro dermal responses (EDR), electroencephalograms (EEG), visual evoked potential (VEP), and auditory evoked responses (AER); working electrodes for Transcutaneous Electrical Nerve Stimulation (TENS), used as a Electro-Surgical Unit (ESU), External Cardiac Pacing (ECP) and for Defibrillation (DEFIB) electrodes used in medical diathermy, such as endothermy, short wave diathermy, ultrasonic diathermy and medical thermo penetration.
0042] These and other objects and advantages of the present invention will become readily apparent from the following detailed description taken in conjunction with the accompanying drawings.
E) BRIEF DESCRIPTION OF THE DRAWINGS
[43] The other objects, features and advantages will occur to those skilled in the art from the following description of the preferred embodiment and the accompanying drawings in which:
[44] FIGURE.l illustrates a perspective view of a press stud basic electrode according to one embodiment of the present invention.
[45] FIGURE,2 illustrates a top side exploded view of a circular electrode with a magnet contact according to one embodiment of the present invention.
[46] FIGURE,3 illustrates a schematic diagram indicating the sequence of process during the manufacture of a bio degradable medical electrode according to one embodiment of the present invention.
[47] FIGURE.4 illustrates a side sectional view of a reusable cup type medical electrode according to one embodiment the present invention.
[48] FIGURE.5 illustrates a top side perspective view of a sheet assembly for dispensing medical electrodes according to one embodiment of the present invention.
[49] FIGURE.6 illustrates a side sectional view of a clamp type medical electrode and exploded side sectional view of ECG signal collection unit according to one embodiment of this invention.
[50] Although specific features of the present invention are shown in some drawings and not in others. This is done for convenience only as each feature may be combined with any or all of the other features in accordance with the present invention.
F) DETAILED DESCRIPTION OF THE INVENTION
0051] In the following detailed description, reference is made to the accompanying drawings that form a part hereof, and in which the specific embodiments that may be practiced is shown by way of illustration. These embodiments are described in sufficient detail to enable those skilled in the art to practice the embodiments and it is to be understood that the logical, mechanical and other changes may be made without departing from the
scope of the embodiments. The following detailed description is therefore not to be taken in a limiting sense.
[52] The various embodiments of the present invention provides a bio degradable, em^onmentaJ friendly medical electrode and its construction method. The present invention develops and constructs a bio degradable and environmentally free medical electrode that tries to solve the problems faced by the currentiy available medical electrodes during the electrode waste disposal process.
According to one embodiment of this invention, a bio-degradable medical electrode for ECG or ICVG device is provided. The bio-degradable and environment friendly disposable medical electrode has a conductive element containing a connector for an external electrical device. The conductive element is attached to an insulator. The insulator is made up of a leaf plate formed using the Areca Catechu Linn Palm. Alternatively the insulator is made up of bio-degradable plastic. The electrode is stuck to the body of a patient using a gum such as plant based gum like gum karaya or guar bean gum or Locust bean gum or gum acacia/Arabica.
[56] Areca Catechu Linn Palm is extensively cultivated in South India as a cash crop. The Areca Catechu Linn Palm supplies a strong pliable material that may be easily converted into any shape or any form. The palm product is easily obtained from the plant leaf part, which in the course of its biological life cycle, dries, falls and regenerates. The naturally shed leaf sheath is strong, semi flexible, odorless.
[57] The palm leaf has water and heat resistant properties. This leaf sheath has its own natural grains and characteristic texture, very much similar to those seen in furniture grade wood. Because of the above amazing properties, the palm leaf is used to manufacture a wide variety of items of day-to-day use such as disposable plates, rain caps etc.
[58] The Palm shed leaf sheaths are first carefully sorted and then thoroughly washed and mechanically pressed in a pre-heated form. A final trimming process is performed to provide a final finishing touch to the products. No chemicals, resins, dyes, strengthening agents and synthetic materials of any kind are used in the entire manufacturing process. A specialized baking & sterilization processes are performed to ensure that the plates are totally germ free, hygienic, and suitable for using as food grade or medical grade for external application. Even though the palm plates are
extremely sturdy and hard, they are comparatively very light in weight. Its leak proof property and the ability to withstand the hot and cold temperatures make the palm leaf made insulator plate a suitable product for use in a medical field and in food industry. The palm leaf plate is biodegradable in nature so that it may be easily disposed off after every use and it decays over a period of time with the soil like any other naturally shed leaf Since it is easily combustible it can be burnt in an incinerator without generating any toxic gas or vapour.
0059] The outer surface of the sheath is greenish or brown, waxy and tough, while the inner surface is creamy in colour. The sheath has natural grains and glossy finish. A special soft grade Areca Catechu Linn palm leaf sheaths are manufactured for making the electrode insulator used in this invention. The special soft grade Areca catechu Linn palm is formed by removing the outer surface of the naturally available palm leaf sheaths by steam heating the palm leaf sheaths and pressing the heat treated palm leaf sheaths using special machines. The palm leaf sheaths produced during the months of January to August are only used to manufacture the highly flexible insulator plates.
[0060] Thus the areca palm leaf selected from the farms are cleaned and the
V unwanted portions are removed to obtain a machinable portion. The machinable portion of the leafs are cut into the desired flexible, dimensionally stable nonconductive substrates. The cut, non conductive substrates are pressed and stamped using a punching die to ensure that the shape of the electrode complies with that of the body surface at which the electrodes are to be affixed to monitor the desired physiological parameters, like heart rate, blood pressure, artery pressure, etc. Then either a press -stud connector or a magnetic connector is fixed after making a suitable hole in the substrate surface.
0061] The electrode may be formed in any predetermined geometrical configuration such as a circle, oval, square, rectangle, head cap, belt, etc. The shape of the electrodes mentioned in the embodiments given in this present invention is by way of example and for purposes of illustration only and not to be construed as a limiting sense of the present invention.
[0062] According to another embodiment of the present invention, a bio¬degradable plastic made up starch material is used to form an insulator plate. The biodegradable plastic is a plastic made from the lactic acid, which is obtained through the fermentation of com-starch. The bio -degradable
plastic which is a starch based plastic. The starch based plastic is a non- petroleum based plastic obtained from the starch obtained from corn, wheat or potatoes, etc., so that the insulator can be disposed off after each use in an environmentally friendly manner. In the soil or water, the disposed or waste plastic is converted into water and carbon dioxide by microbes for absorption by the green plants during a photosynthesis process to generate a starch again. Thus the starch based plastic is namrally recyclable. The insulator made from areca palm leaf or made from a starch based plastic is used instead of styro foam, urethane plastic or foam, etc., which are currendy used to manufacture the insulator plates.
[63] The electrode is affixed to a desired location on the body of a patient using either "Gum Karaya (Indian Tragacanth) or a starch based conductive gum etc. The other naturally available gums in India like locust bean gum , Neem (Azadirachta indica) exudate gum, Indian ghatti gum (Acacia Arabica), Guar gum may also can be used instead of Gum Karaya.
[64] The Gum Karaya is the dried exudates of the Sterculia Urens tree of the Sterculiaceae family. This large and bushy deciduous tree is found in the dry deciduous forests of the Indian Peninsula, the rocky hills of Madhya Pradesh and Bihar and the sub-Himalayan tract in northern India. The local
residents tap the trees by making incisions up to one square foot in dimension on the trunk. The gum begins to exude immediately and the exudation continues for several days. The maximum amount of exudation occurs within the first 24 hours. The gum is in the form of huge irregular tears. The grades and their technical specifications are as follows. The Gum Karaya occurs naturally as a complex, partially acetylated, branched polysaccharide of high molecular weight. It contains about 37% uronic acid residues and approximately 8% acetyl groups. The gum has a peculiar property of splitting off free acetic acid and this loss is loosely correlated with the particle size. Karaya is a calcium and magnesium salt, with a central chain of D-galactose, L-rhamnose and D-galacturonic acid units, with some side chains containing D-glucuronic acid.
[0065] Although designated as a water- soluble gum, Karaya is one of the least soluble of the exudation gums. A gum particle placed in water does not dissolve but absorbs water and swells to many times its original size. The particle size influences the type of the dispersion obtainable. This property of the gum Karaya is particularly useful, when the gum is applied to the skin of the patient. So, the gum will absorb sweat to reduce the impedance between the skin and the electrode. The electrolytes such as sodium, calcium and aluminum chlorides and alutninum sulphate are present in this gum.
0066] According to another embodiment of the present invention, a circular electrode with a magnetic contact is provided instead of the conductive stud. The electrode assembly has a lower assembly and an upper assembly. The lower electrode assembly has an insulating layer arranged over a steel plate installed with a central conductor. An upper electrode assembly connected with the lower electrode assembly includes a dome contact which is coupled to a doughnut shaped permanent magnet. The dome contact has a central conductive lead which is made to engage with the central conductive part in the lower electrode assembly, when the dome contact is pressed during the mating of the lower and the upper electrode assemblies. When both the electrode assemblies are coupled together, the permanent magnet attracts the steel plate and the central conductive parts of both the electrode assemblies are made to contact each other to provide a strong electrical connection to transmit the measurement signals to a monitor interface, even when there is a vibration or motion.
[0067] According to another embodiment of the present invention, a medical electrode manufacturing method is disclosed. A special soft grade Areca Catechu Linn pakn leaf sheaths are selected and used as an electrode insulator. The special soft grade Areca catechu Linn palm is formed by removing the outer surface of naturally available palm leaf sheath by steam heating the palm leaf sheaths and pressing the heat treated palm leaf sheaths using special machineries. The Palm shed leaf sheaths are first carefully sorted and then thoroughly washed. The machine-able portion is retained and mechanically pressed in a pre-heated form/dye. A final trimming process is executed to provide a final finish to the products. No chetnicals, resins, dyes, strengthening agents and synthetic materials of any kind are used in the entire manufacturing process. A specialized baking & sterilisation processes are performed to ensure that the plates are totally germ free, hygienic, and suitable for using as food grade or medical grade for external application.
[0068] The pre~treated and processed areca palm leaf sheaths are cut into the flexible, dimensionally stable nonconductive substrates of desired sizes. In order to change the shape of the electrode to that of a body surface, the cut substrates are pressed using a pressing & stamping equipment The substrate is fixed on a base plate. A shaft is arranged above the base plate and is moved vertically. A metallic plate is fixed to the shaft to move the plate to press the substrate mounted on the base plate by moving the shaft downwardly, so that the substrate is compressed to remove the water and the trapped air'from the substrate to increase the density of the substrate. At the same time, an electrode outline in oval/rectangular shape is formed on the substrate using a punch, so that the electrode portion may easily be separated from the compressed substrate. The compressed substrate is drilled. The holes are formed on the centre of the electrode using a drilling bit The substrate thus formed is further cleaned using forced /pressurized air /fumigation gas or any other sterilizing gases to obtain a substrate which is free from burrs and fine dust particles
[69] During the next stage of manufacturing, the press stud connector parts are fixed from the top and the bottom of the electrode. The automatic electrode and adhesive dispensing machines such as syringes are automatically moved forward to dispense preset amount of hydro gel in to the centre of the pit region and the adhesive in to outer peripheral area of the drilled substrate. The electrode is oriented vertically until the hydro gel and the adhesive are converted in to gel form. Then the press stud parts will be coated with silver-chloride so that there will not be galvanic voltage build-up between the gel and the metallic stud. In one embodiment of the invention, magnetic connectors are used instead of press smds.
[70] According to one embodiment of the present invention, a cup type
■I' ' ' . . - 1 _ 1.: 1 J C^^ Kt7 oH/^lnrr
the ECG gel in intervals, has an outer insulation cup made from either Areca Catechu Linn Palm leaf or bio degradable plastic. A metallic press stud plug is inserted into the cup type structure and fixed. A disc is attached to the bottom of the stud and is coated with silver chloride /oxidized to reduce the galvanic barrier between a conductive gel and the metallic press stud.
[71] A sponge impregnated with solid gel is provided on a conductive substrate arranged below the press stud. A nonconductive moisture impermeable barrier layer including an acrylic plastic or the like is applied over the conductive surface layer on the substrate. An adhesive ring is fomied at the bottom of the cup like structure. Moreover, the sponge impregnated with solid gel is installed between the paste and a label to prevent the paste from oozing towards the side surface of the label. Therefore, the paste does not ooze out during storage of a bio-electrode. The inner lining of the cup like structure may be coated with silver paint.
[72] At least two holes are provided at the mutually opposite sides of the outer insulation cup in one embodiment to inject ECG gel into the sponge to carry out continuous monitoring process or when the medical electrode is reused. When a doctor requires a very long term monitoring of the patient, then these type of electrodes are used to monitor the patient continuously. During the long term monitoring process, the ECG gel will dry up during the course of monitoring and the replenishment of the ECG gel is requked to carryout the monitoring operation continuously without a break. A standard syringe may be used to inject the ECG gel into the sponge. The ECG gel will be injected into the electrode forcefully through one hole so that the used gel will be forcefully ejected out through another hole. Thus the reading the gel may be refilled and the long term monitoring may be achieved continuously without stopping the monitoring process for refilling the reading gel.
[0073] According to another embodiment of the present invention, a disposable cup type medical electrode is provided with a cup structure formed using the bio degradable material like Areca Catechu Linn Palm leaf or from a bio-degradable plastic such as plastic made from starch based resin material. The biodegradable plastic is a plastic made from the lactic acid, which is obtained by the fermentation process of corn-starch material. The bio -degradable plastic is a starch based plastic and is a non-petroleum based plastic obtained from starch recovered from the com, wheat or potatoes so that the insulator may be disposed off after each use in an environmentally friendly manner. In the soil or water, the disposed or waste
plastic is converted into water and carbon dioxide by the microbes and if absorbed by the green plants during a photosynthesis process to generate j starch again. Thus the starch based plastic is naturally recyclable.
[74] According to another embodiment of the present invention, a reusable type medical electrode is provided. A cup type medical electrode may be used for long term monitoring by adding the ECG gel in intervals, has an outer insulation cup made from either Area Catechu Linn Palm leaf or bio degradable plastic. A metallic press stud plu^ is inserted into the cup type strucmre and fixed. A disc is attached to th( bottom of the stud and is coated with silver chloride /oxidized to reduc( the galvanic barrier between a conductive gel and the metallic press smd.
[75] A sponge impregnated with solid gel is provided on a conductiv< substrate arranged below the press stud. A nonconductive moisturi impermeable barrier layer including an acrylic plastic or the like is applie< over the conductive surface layer on the substrate. An adhesive ring i formed at the bottom of the cup like structure. Moreover, the spong impregnated with solid gel is installed between the paste and a label t( prevent the paste from oozing towards the side surface of the labe
Therefore, the paste does not ooze out during storage of a bio-electrode. The inner lining of the cup like structure may be coated with silver paint.
[76] At least two holes are provided at the mutually opposite sides of the outer insulation cup in one embodiment to inject ECG gel into the sponge to carry out continuous monitoring process or when the medical elecdx)de is reused. When a doctor requires a very long term monitoring of the patient, then these type of electrodes are used to monitor the patient continuously. During the long term monitoring process, the ECG gel will dry up during the course of monitoring and the replenishment of the ECG gel is required to carryout the monitoring operation continuously without a break. A standard syringe may be used to inject the ECG gel into the sponge. The ECG gel will be injected into the electrode forcefully through one hole so that the used gel wiU be forcefully ejected out through another hole. Thus the reading the gel may be refilled and the long term monitoring may be achieved continuously without stopping the monitoring process for refilling the reading gel.
[77] The disposable cup type medical electrode is provided with a cup structure formed using the bio degradable material like Areca Catechu Linn Palm leaf or from a bio-degradable plastic such as plastic made from starch
based resin material. The biodegradable plastic is a plastic made from the lactic acid, which is obtained by the fermentation process of corn-starch material. The bio -degradable plastic is a starch based plastic and is a non- petroleum based plastic obtained from starch recovered from the com, wheat or potatoes so that the insulator may be disposed off after each use in an environmentally friendly manner. In the soil or water, the disposed or waste plastic is converted into water and carbon dioxide by the microbes and is absorbed by the green plants during a photosynthesis process to generate a starch again. Thus the starch based plastic is naturally recyclable.
[0078] According to another embodiment of this invention, a patient plate for a diathermy device is provided. The patient plate has a metal foil secured to one surface of insulating material such as leaf plate made from Areca Catechu Linn Palm leaf or from a bio degradable plastic such as plastic made from starch material. The metal foil has a contact edge for connection with a diathermy de\ice. A slot is formed in the foil extending from the contact edge towards an opposing edge of the foil so that the foil defines a generally U-shaped pattern to provide a conducting area to a patient and the slot is formed free of the foil. A pressure sensitive adhesive material is coated on the surface of the sheet of insulating material, to secure a metallic
foil to the insulating sheet so that the coating film is exposed through the slot to affix a patient plate at a desired location of the patient.
0079] According to another embodiment of this invention, an assembly for dispensing electrodes used in the EGG devices is provided. The assembly- has several electrodes mounted on a carrier sheet made up of leaf plate formed from areca palm leaf or a starch based plastic material. A pull strip is releasably mounted on the carrier sheet to cover the tabs of the electrodes so that the electrodes are successively exposed as the pull strip is puUed upwardly. The assembly has a carrier sheet provided with at least two generally parallel and longitudinal tear lines so that the tear lines are extended along the carrier sheet. The carrier sheet is made up of an Areca catechu Linn Palm or starch based plastic card. Several electrodes are mounted in multiple rows in parallel on the bio-degradable carrier sheet over the tear lines. The electrodes are oriented with the respective tabs extending away from the center of the carrier sheet so that the electrodes are successively exposed as the carrier sheet is torn along the tear lines to facilitate access to the tabs of electrodes. Alternatively a puU strip is rpleasably mounted on the carrier sheet made up of a leaf plate formed from areca palm leaf or a starch based plastic material to cover the electrodes so that the electrodes arranged in the multiple rows are successively exposed, as the removable pull strip is pulled upwardly from the carrier sheet to facilitate access to the tabs of the electrodes.
[0080] The carrier sheet is marked with several icons or logos of various organs in the body. A respective electrode is affixed in each location marked with an icon or logo of an organ. Each an The electrodes are released from a location marked with a logo or icon indicating an organ in the dispenser sheet and are attached to the respective organ in the human body thereby eliminating the generation of error in fixing the electrodes at various organs in the human body. Thus the assembly helps even a semi skilled or unskilled medical attendant to fix the electrodes at the organs easily, efficiently, effectively and accurately. Alternately the electrodes fixed at different locations on the sheet are marked with different colors and the leads of the patient cable are marked with different colors to enable easy and quick connection of the electrodes with the respective cable leads. The usage of such colored cable leads and colored electrodes helps a care-giver to connect the leads of the patient cable with different colors to the respective electrodes by matching the colors of the electrode with that of the cable
[81] According to another embodiment of the present invention, a clamp type medical electrode is provided. The clamp type electrode for an electrocardiograph includes a pair of clamping jaws having concave surfaces that are arranged opposite to each other. An electrode formed in a metal plate shape is attached to the inner surface of the upper clamping jaw. The two jaws are opened and closed relative to each other using a tension adjustable leaf spring. The tension adjustable spring applies a required clamping force to the clamping jaws based on the thickness of the limb to which the electrode is to be attached, so that a patient undergoing electrocardiographic diagnosis will not experience any discomfort. By adjusting the tension of the circular spring part based on the thickness of the limb, a clamp type electrode is attached to a limb, such as the wrist or ankle of a human body.
[82] The two jaws are manufactured from Areca Catechu Linn palm leaf plates. For a true biodegradable electrode, the spring may be manufactured using plant based stems after bending the stems in the required shape. The metal plate type electrode provided at the inner concave surface may be made up of sintered porous metal plate which may hold the gel for longer period of time. The metal plate is used to acquire ECG signals from the wrist or ankle of a human body. The metal plate may be manufactured from brass or AS316L stainless steel plate. The lower clamping jaw is coated with silver chloride layer to increase the signal fidelity. A connecting terminal is screwed to the metal plate to couple the electrode to the ECG patient lead. The connecting terminal has a hole to receive a banana plug from a patient interface cable. The electrodes are need to be identified by their color. The commonly used colors are RED, YELLOW, BLACK and GREEN. Since the areca plate does not have these colors, the naturally available/plant based colors may be applied on the outer surface of the upper clamping jaw. The electrodes are used as follows. The two edges of the circular spring clamp are pressed so that the two jaws are opened to receive a desired limb. The ECG gel is applied to the lower clamp jaw. After bringing the electrode over desired location, the edges of the spring clamp are released,
[0083] According to another embodiment of this invention, a disposable skin conducting electrode assembly is provided. The electrode assembly contains an electrolyte pad, an electrode and an adhesive pad made from areca nut palm leaf To replenish the conductive gel, two holes are provided on the top portion of the cup where conductive gel can be injected using syringe. The conductive gel is replenished to enable bio impedance measurement for a longer period of time.
[84] According to another embodiment of this invention, an EEG head cap made up of areca palm leaf is provided. The head cap made up of areca palm leaf or starch based plastic is provided with several holes on the surface for inserting and mounting medical electrodes.
[85] According to another embodiment of this invention, a disposable skin conducting electrode assembly is provided. The electrode assembly contains an electrolyte pad, an electrode and an adhesive pad made from areca nut palm leaf. The electrode is a thin stainless steel plate having a periphery shaped to provide a plurality of recesses in the contour. The adhesive pad is a solid sheet having greater overall length and width dimensions than the electrode. Thus the adhesive pad extends over the recesses in the periphery of the electrode and provides greater adhesive area for affixing the electrode assembly to the skin of the patient. An external conductor is connectable to a conductive, single piece, solid metal stud or post attached to the electrode extending through an orifice in the adhesive pad. Pair of washers are mounted on the stud on either side of the adhesive pad for mechanically retaining the stud and electrode in position.
[86] The FIG.l illustrates a perspective view of a press stud type basic bio degradable medical electrode according to one embodiment of the present nvention. A bio-degradable medical electrode 100 such as ECG or ICVG electrode containing an insulator having a bio-degradable material is :)rovided so that the electrode 100 is disposable and bio-degradable after sach use. The electrode 100 is disposed in an environmentally friendly nanner with out generating any adverse effect on the environment. The bio degradable electrode 100 of this present invention has insulator made up of a bio~plate 112 formed using the leaf sheath of Areca Catechu Linn Pakn or in insulator made up of bio -degradable plastic such as plastic made from starch material, instead of Styro-foam / URETHANE PLASTIC / FOAM (petroleum /hydrocarbon based) that are used as insulator in the currentiy available electrodes in the market A gum such as a plant based gum is used for sticking an electrode 100 to the body of a human being at a desired location. One such preferred gum is Gum Karaya is the dried exudates of the Sterculia Urens tree of the Sterculiaceae family.
[0087] With reference to FIG. 1, a press stud type basic medical electrode 100 contains a metallic press stud 102 connected to an electrode assembly mounted on a plastic tape or release liner 104. The electrode assembly 100 has an electrolyte layer 110 sandwiched between two adhesive layers 106,108. An insulating tape is arranged at the uppermost layer of the electrode assembly. The press stud 102 is provided to establish an electrical piastic tape or release liner is provided at the lowermost layer of the electrode assembly 100. The insulator plate 112 in the electrode assembly is made up of bio degradable material like the leaf sheath of Areca Catechu Linn Palm, etc. The upper adhesive layer 108 is formed by injecting the adhesive particles through an injection machine. The electrolyte layer 110 contains hydro gel or starch loaded with conductive particles. The lower adhesive layer 106 is a conductive adhesive layer formed by using the KARAYA gel or gum ARABICA or gum gutti or starch based gum.
[0088] According to another embodiment of the present invention, the bio plate 112 is made up of bio -degradable plastic such as plastic made from starch material, instead of Styro-foam / URETHANE PLASTIC / FOAM (petroleum /hydrocarbon based) that are used as insulator in the currently available electrodes in the market. The biodegradable plastic is a plastic made from the lactic acid, which is obtained by the fermentation process of corn-starch material. The bio -degradable plastic is a starch based plastic and is a non-petroleum based plastic obtained from starch recovered from the corn, wheat or potatoes so that the insulator may be disposed off after each use in an environmentally friendly manner. In the soil or water, the disposed or waste plastic is converted into water and carbon dioxide by the microbes and is absorbed by the green plants during a photosynthesis process to generate a starch again. Thus the starch based plastic is naturally recyclable.
[0089] The FIG.2 illustrates a top side exploded view of a circular bio degradable electrode 200 with a magnet contact according to one embodiment of the present invention. A circular electrode is provided with a magnetic contact instead of the conductive stud. The electrode assembly has a lower assembly and an upper assembly. The lower electrode assembly has an insulating layer 214 arranged over a steel plate 212 installed with a central conductor 216. An upper electrode assembly connected with the lower electrode assembly includes a dome contact 204 which is coupled to a doughnut shaped permanent magnet 210. The dome contact 204 has a central conductive lead 206 which is made to engage with the central conductive part 216 in the lower electrode assembly, when the dome contact 204 is pressed during the mating of the lower and the upper electrode assemblies. When both the electrode assemblies are coupled together, the permanent magnet 210 attracts the steel plate 212 and the central conductive parts 206,216 of both the electrode assemblies are made to contact each other to provide a strong electrical connection to transtnit the measurement signals to a monitor interface, even when there is a vibration or motion.
The electrode is connected to a monitor through a cable 208 so that the measurement signals are transmitted through the cable 208.
[90] The FIG.3 illustrates a schematic diagram indicating the sequence of process during the manufacttire of a bio degradable medical electrode according to one embodiment of the present invention.
[91] A special soft grade Areca Catechu Linn palm leaf sheaths are selected and used as an electrode insulator. The special soft grade Areca catechu Linn palm is formed by removing the outer surface of naturally available palm leaf sheath by steam heating the palm leaf sheaths and pressing the heat treated palm leaf sheaths using special machineries. The Palm shed leaf sheaths are first carefully sorted and then thoroughly washed. The machine-able portion is retained and mechanically pressed in a pre¬heated form/dye. A final trimming process is executed to provide a final finish to the products. No chemicals, resins, dyes, strengthening agents and synthetic materials of any kind are used in the entire manufacmring process. A specialized baking Sc sterilization processes are performed to ensure that the plates are totally germ free, hygienic, and suitable for using as food grade o!r medical grade for external application.
[0092] The pre-treated and processed areca palm leaf sheaths are cut into
the flexible, dimensionally stable nonconductive substrates 302 of desired
sizes. In order to change the shape of the electrode to that of a body surface,
the cut substrates 302 are pressed using a pressing & stamping equipment
304. The substrate 302 is fixed on a base plate 306 and pressed with a punch
304. A shaft 308 is arranged above the punch 304 and is moved vertically to
move the punch along a vertical direction. A metallic plate 304 is fixed to
the shaft to move the plate 304 to press the substrate 302 mounted on the
base plate 306 by moving the shaft 308 downwardly, so that the substrate
302 is compressed to remove the water and the trapped air from the
substrate 302 to increase the density of the substrate 302, At the same time,
an electrode outline 312 in oval/rectangular shape is formed on the
substrate 302 using a drilling bit 310, so that the electrode portion 312 may
easily be separated from the compressed substrate 302. The compressed
substrate 302 is drilled. The holes 324 are formed on the centre of the
electrode 312 using a drilling bit 310. The substrate thus formed is further
cleaned using forced /pressurized air / fumigation gas or any other
sterilizing gases to obtain a substrate which is free from burrs and fine dust
(
particles.
[93] During the next stage of manufacturing, the press stud connector parts 318,320 are fixed from the top and the bottom of the electrode. The automatic electrode and adhesive dispensing machines 316, 314 such as syringes are automatically moved forward to dispense preset amount of hydro gel in to the central pit region 324 and the adhesive in to outer peripheral area 322 of the drilled substrate 302. The electrode is oriented vertically until the hydro gel and the adhesive are converted in to gel form. Then the press stud parts 318, 320 will be coated with silver-chloride so that there will not be galvanic voltage build-up between the gel and the metallic stud. In one embodiment of the invention, magnetic connectors are used instead of press studs.
[94] FIGURE. 4 illustrates a side sectional view of a reus able/disposable cup type medical electrode according to one embodiment the present invention. The cup type medical electrode 400 which may be used for long term monitoring by adding the ECG gel in intervals, has an outer insulation cup 406 made from either Areca Catechu Linn Palm leaf or bio degradable plastic. A metallic press stud plug 402 is inserted into the cup type structure and fixed. A disc 416 is attached to the bottom of the smd and is coated with silver chloride /oxidized to reduce the galvanic barrier between a conductive gel and the metallic press stud 402,
[95] A sponge 410 impregnated with solid gel is provided on a conductive substrate 408 arranged below the press stud. A nonconductive moisture impermeable barrier layer 412 including an acryKc plastic or the like is applied over the conductive surface layer on the substrate. An adhesive ring 414 is formed at the bottom of the cup like structure. Moreover, the sponge 410 impregnated with solid gel is installed between the paste and a label to prevent the paste from oozing towards the side surface of the label. Therefore, the paste does not oo^e out during storage of a bio-electrode. The inner lining of the cup like structure may be coated with silver paint.
[96] At least two holes 404, 418 are provided at the mumally opposite sides of the outer insulation cup 406 in one embodiment to inject ECG gel into the sponge to carry out continuous monitoring process or when the medical electrode is reused. When a doctor requires a very long term monitoring of the patient, then these type of electrodes are used to monitor the patient continuously. During the long term monitoring process, the ECG gel will dry up during the course of monitoring and the replenishment of the ECG gel is required to carryout the monitoring operation continuously without a break. A standard syringe 420 may be used to inject the ECG gel into the sponge. The ECG gel will be injected into the
electxode forcefully through one hole 404 so that the used gel will be forcefully ejected out through another hole. Thus the reading the gel may be refilled and the long term monitoring may be achieved continuously without stopping the monitoring process for refilling the reading gel.
[97] A disposable cup type medical electrode 400 is provided with a cup structure 406 formed using the bio degradable material like Areca Catechu Linn Palm leaf or from a bio-degradable plastic such as plastic made from starch based resin material. The biodegradable plastic is a plastic made from the lactic acid, which is obtained by the fermentation process of corn-starch material. The bio -degradable plastic is a starch based plastic and is a non- petroleum based plastic obtained from starch recovered from the com, wheat or potatoes so that the insulator may be disposed off after each use in an environmentally friendly manner. In the soil or water, the disposed or waste plastic is converted into water and carbon dioxide by the microbes and is absorbed by the green plants during a photosynthesis process to generate a starch again. Thus the starch based plastic is naturally recyclable.
[98] FIGURE.5 illustrates a top side perspective view of a sheet assembly 500 for dispensing medical electrodes according to one embodiment of the present invention. An assembly 500 for dispensing
trodes is used in the "impedance cardio vasograph" commercially wn as "ICVG machine". The assembly 500 has several electrodes 504 inted on a carrier sheet 502 made up of leaf plate formed from areca n leaf or a starch based plastic material. A pull strip 506 is releasably inted on the carrier sheet to cover the tabs of the electrodes 504 so that electrodes 504 are successively exposed as the pull strip 506 is pulled ^ardly.
)9] The electrode dispensing assembly 500 has a carrier sheet 502 vided with at least two generally parallel and longitudinal tear lines so : the tear lines are extended along the carrier sheet 500, The carrier sheet is made up of an Areca catechu Linn Palm or starch based plastic card, eral electrodes 504 are mounted in multiple rows in parallel on the bio- radable carrier sheet 500 over the tear lines. The electrodes 504 are :nted in such a manner that the respective tabs of the electrodes 504 are inded away from the centre of the carrier sheet 502 and the electrodes ■ are successively exposed as the carrier sheet 502 is torn along the tear :s to facilitate easy access to the tabs of electrodes 504. Alternatively a { strip 506 is releaseably mounted on the carrier sheet 500 made up of a ^ plate formed from areca palm leaf or a starch based plastic material to ^er the electrodes 504 so that the electrodes 504 arranged in the multiple
rows are successively exposed, as the removable pull strip 506 is pulled upwardly from the carrier sheet 502 using a pull tab part 508 to facilitate access to the tabs of the electrodes 504. The electrodes 504 released from a location indicating an organ from the dispenser sheet 502 are attached to the location of the respective organ in the human body.
[100] The leads of the patient cable are marked with different colors 510. The usage of such colored cable leads and colored electrodes helps a care¬giver to connect the leads of the patient cable with different colors to the respective electrodes by matching the colors of the electrode 504 with that of the cable leads.
The FIG.6 illustrates a side sectional view of a clamp type medical electrode 600 and exploded side sectional view of ECG signal collection unit according to one embodiment of this invention. The clamp type electrode 600 for an electrocardiograph includes a pair of clamping jaws 606, 610 having concave surfaces that are arranged opposite to each other. An electrode 604 formed in a concave metal plate shape is attached to the inner surface of the upper clamping jaw 606. The two jaws 606,610 are opened and closed relative to each other using a tension adjustable leaf spring 608. The tension adjustable leaf spring 608 applies a required clamping force to
the clamping jaws 606,610 based on the thickness of the limbs to which the electrode 604 is to be attached, so that a patient undergoing electrocardiographic diagnosis will not experience any discomfort. By adjusting the tension of the circular spring part based on the thickness of the limb, a clamp type electrode 600 is attached to a limb, such as the wrist or ankle of a human body.
[0102] The two jaws 606, 610 are manufactured from Areca Catechu Linn palm leaf plates. For a tme biodegradable electrode 600, the spring 608 may be manufactured using plant based stems 612, 614 after bending the stems 612,614 in the required shape. The concave metal plate type electrode 604 provided at the inner concave surface may be made up of sintered porous metal plate 604 which may hold the gel for longer period of time. The metal plate 604 is used to acquire ECG signals from the wrist or ankle of a human body. The metal plate 604 may be manufactured from brass or AS316L stainless steel plate. The lower clamping jaw 610 is coated with silver chloride layer to increase the signal fidelity. A connecting terminal 602 is screwed to the metal plate 604 to couple the electrode 604 to the ECG patient lead. The connecting terminal 602 has a hole 622 provided in an elongated stem 624 to receive a banana plug from a patient interface cable. The electrodes are need to be identified by their color. The commonly used colors are RED, YELLOW, BLACK and GREEN. Since the areca plate does not have these colors, the naturally available/plant based colors may be applied on the outer surface of the upper clamping jaw. The electrodes are used as follows. The two edges 612,614 of the circular spring clamp 608 are pressed so that the two jaws 606, 610 are opened to receive a desired Kmb. The ECG gel is applied to the lower clamp jaw 610. After bringing the electrode 604 over desired location, the edges 612, 614 of the spring clamp 608 are released. The plate type electrode 604 has a metal plate 618 connected to a terminal through a fastener such as a screw 616. The screw terminal 602 has a screw head 620 which is moved inside the hole 622 to hold a cable lead.
[0103] The electrodes of the present invention can be used in a wide variety of fields including medical electrodes. The examples of such electrodes are sensing electrodes used in electro-cardiogram (ECG), electro oculogram (EOG), electro gastro gram (EGG), surface. electro myogram (EMG), electro dermal responses (EDR), electroencephalograms (EEG), visual evoked potential (VEP), and auditory evoked responses (AER); working electrodes for Transcutaneous Electrical Nerve Stimulation (TENS), used as a Electro-Surgical Unit (ESU), External Cardiac Pacing (ECP) and for
^ -11 Siirh
endothermy, short wave diathermy, ultrasonic diathermy and medical thermo penetration.
G) ADVANTAGES OF THE INVENTION
[0104] The various embodiments of the present invention provide a bio degradable medical electrode and its manufacturing method. The bio degradable medical electrode is provided with an insulator made up of naturally available environmentally friendly bio degradable material like leaf sheath of Areca Catechu Linn palm leaf plates or plastic made from starch based plastic thereby reducing the cost of the device. The used medical electrodes may be disposed in an environmentally friendly manner and prevents the generation of toxic wastes. Since the cost of the device is reduced, the medical electrodes may be disposed of after each use thereby preventing the generation of cross contamination due to the use of electrodes for several times with pluralities of patients.
[0105] Although the invention is described with various specific embodiments, it will be obvious for a person skilled in the art to practice the invention with modifications. However, all such modifications are deemed to be within the scope of the claims.
[0106] It is also to be understood that the following claims are intended to cover all of the generic and specific features of the present invention described herein and all the statements of the scope of the invention which as a matter of language might be said to fall there between.
<3
Date: January 30th, 2008 Gounse] for the Applicant
Place: Bangalore Rakesh Prabhu

CLAIMS
WHAT IS CLAIMED IS:
1. A bio degradable medical electrode device, the device comprising: A substrate including an electrolyte layer;
An insulator layer arranged over the substrate containing the electrolyte layer; and
An electrode contact terminal attached to the substrate including the said electrolyte layer;
Wherein the insulator layer is made up of bio degradable material
2, The electrode device according to claim 1, wherein the bio degradable material is a naturally available material.
3. The electrode device according to claim 1, wherein the bio degradable material is a leaf material
4. The electrode device according to claim 1, wherein the insulator is made up of Areca Catechu Linn palm leaf plates.
5. The electrode device according to claim 1, wherein the insulator is made up of bio degradable plastic material.
6. The electrode device according to claim 1, wherein the insulator is made up of non petroleum based plastic material
7. The electrode device according to claim 1, wherein the insulator is made up of starch based plastic material.
8. The electrode device according to claim 1, further comprising an adhesive layer to stick an electrode material to a human body.
9. The electrode device according to claim 8, wherein the adhesive layer includes a gum for sticking the electrode material to the human body.
10. The electrode device according to claim 9, wherein the gum is a plant based gum.
11. The electrode device according to claim 10, wherein the gum is Gum Karaya that is the dried exudates of the Sterculia Urens tree of the Sterculiaceae family.
12. The electrode device according to claim 9, wherein the gum is gum Arabica.
13. The electrode device according to claim 9, wherein the gum is gum gutti.
14. The electrode device according to claim 9, wherein the gum is starch based gum.
15. The electrode device according to claim 1, wherein the electrolyte layer contains hydro gel.
16. The electrode device according to claim 1, wherein the electrolyte layer contains starch loaded with conductive particles.
17. The electrode device according to claim 1, wherein the electrolyte layer contains hydro gel
18. The electrode device according to claim 1, wherein the electrode contact terminal is a conductive press stud.
19. The electrode device according to claim 18, wherein the conductive press stud is a metallic press stud.
20. The electrode device according to claim 1, wherein the electrode contact terminal is a magnetic contact.
21. A bio degradable medical electrode device, the device comprising: A substrate including an electrolyte layer;
An insulator layer arranged over the substrate containing the electrolyte layer;
An electrode contact terminal attached to the substrate including the said electrolyte layer; and
An adhesive layer adhered to said substrate including the electrolyte layer;
Wherein the insulator layer is made up of bio degradable material and the adhesive layer includes plant based gum.
22» The electrode device according to claim 21, wherein the bio degradable material is a naturally available material
23. The electrode device according to claim 21, wherein the bio degradable material is a leaf material
24. The electrode device according to claim 21, wherein the insulator is made up of Areca Catechu Linn palm leaf plates.
25. The electrode device according to claim 21, wherein the insulator is made up of bio degradable plastic material
26. The electrode device according to claim 21, wherein the insulator is made up of non petroleum based plastic material
27. The electrode device according to claim 21, wherein the insulator is made up of starch based plastic material
28. The electrode device according to claim 21, wherein the adhesive layer includes a gum for sticking the electrode material to the human body.
29. The electrode device according to claim 28, wherein the gum is a plant based gum.
30. The electrode device according to claim 29, wherein the gum is Gum Karaya that is the dried exudates of the Sterculia Urens tree of the Sterculiaceae family.
31. The electrode device according to claim 28, wherein the gum is gum Arabica.
32. The electrode device according to claim 28, wherein the gum is gum gutti.
33. The electrode device according to claim 28, wherein the gum is starch based gum.
34. The electrode device according to claim 21, wherein the electrolyte layer contains hydro gel.
35. The electrode device according to claim 21, wherein the electrolyte layer contains starch loaded with conductive particles.
36. The electrode device according to claim 21, wherein the electrolyte layer contains hydro gel.
37. The electrode device according to claim 21, wherein the electrode contact terminal is a conductive press stud.
38. The electrode device according to claim 37, wherein the conductive press smd is a metallic press stud.
39. The electrode device according to claim 37, wherein the electrode contact terminal is a magnetic contact.
40. a bio degradable electrode construction method, the method comprising:
pressing a substrate made up of insulating material;
punching the pressed substrate to form electrode regions on the substrate;
drilling the electrode regions to form a central pit region and a peripheral region;
injecting an adhesive material into the peripheral region; and attaching an electrode terminal contact to the electrode region;
wherein the insulating material is made up of bio degradable material.
41. the method according to claim 40, wherein the wherein the bio degradable material is a naturally available material.
42. The method according to claim 40, wherein the bio degradable material is a leaf material.
43. The method according to claim 40, wherein the insulator is made up of Areca Catechu Linn pakn leaf plates.
44. The method according to claim 40, wherein the insulator is made up of bio degradable plastic material.
45. The method according to claim 40, wherein the insulator is made up of non petroleum based plastic material.
46. The method according to claim 40, wherein the insulator is made up of starch based plastic material.
47. The method according to claim 40, wherein the insulated substrate is pressed and compressed using a press unit.
48. The method according to claim 40, wherein the pressed substrate is punched with a punch die to form electrode regions on the substrate.
49. The method according to claim 40, wherein the electrode regions are drilled with a drill unit to form a central pit regions and a peripheral region which is arranged adjacent to the central pit regions.
50. The method according to claim 40, wherein the electrolyte material is injected into the central pit region using an injecting device.
51. The method according to claim 50, wherein the injecting init is a syringe.
52. The method according to claim 40, wherein the electrolyte material includes hydro gel.
53. The method according to claim 40, wherein the electrolyte material includes starch loaded with conductive particles.
54. The method according to claim 40, the adhesive material is injected into the peripheral region using an injecting implement.
55. The method according to claim 54, the injecting implement is a syringe.
56. The method according to claim 40, the adhesive material includes plant based gum.
The method according to claim 56, wherein the plant based gum is Gum Karaya that is the dried exudates of the Sterculia Urens tree of the Sterculiaceae family.
The method according to claim 56, wherein the plant based gum is gum Arabica.
The method according to claim 56, wherein the plant based gum is gum gutti.
The method according to claim 56, wherein the plant based gum is starch based gum.
The method according to claim 40, wherein the electrode contact terminal is a conductive press stud.
The method according to claim 40, wherein the conductive press stud is a metallic press stud.
The method according to claim 40, wherein the electrode contact terminal is a magnetic contact
A bio degradable, disposable medical electrode comprising: An outer insulation cup;
A metallic press stud plug fixed to said outer insulation cup;
A disc attached to bottom of the said stud;
A conductive substrate arranged below the said press stud;
A sponge impregnated with solid gel is provided on the said substrate;
A non conductive moisture impermeable barrier layer arranged over the said substrate;
Wherein the outer insulation cup is made up of bio degradable material and a conductive gel is injected into the sponge during the monitoring process to enable continuous monitoring of parameters.
65. The medical electrode according to claim 64, wherein the outer insulation cup is made up of Areca Catechu Linn Palm leaf.
66. The medical electrode according to claim 64, wherein the cup shaped outer insulation cup is made up of bio degradable plastic.
67. The medical electrode according to claim 64, wherein the bio degradable plastic is non petroleum based plastic.
68. The medical electrode according to claim 64, wherein the bio degradable plastic is a starch based plastic.
69. The medical electrode according to claim 64, further comprises two holes on the outer insulation cup to inject conductive gel and adhesive material respectively to enable continuous monitoring and to make the electrode reusable after each use.
70. The medical electrode according to claim 64, further comprises two injecting implements to inject conductive gel and adhesive material respectively through the two holes on the outer insulation cup.
71. The medical electrode according to claim 68, further comprises two syringes to inject conductive gel and adhesive material respectively through the two holes on the outer insulation cup.
72. The medical electrode according to claim 64, wherein the conductive gel is a gel loaded with starch particles.
73. The medical electrode according to claim 69, wherein the adhesive layer includes a gum for sticking the electrode material to the human body.
74. The medical electrode according to claim 69, wherein the gum is a plant based gum.
75. The medical electrode according to claim 69, wherein the gum is Gum Karaya that is the dried exudates of the Sterculia Urens tree of the Sterculiaceae family.
76. The medical electrode according to claim 69, wherein the gum is gum Arabica.
77. The medical electrode according to claim 69, wherein the gum is gum gutti.
78. The medical electrode according to claim 69, wherein the gum is starch based gum.
79. The medical electrode according to claim 64, wherein the disc attached to the bottom of the stud is coated with silver chloride /oxidized to reduce the galvanic barrier between a conductive gel and the metallic press stud.
80. The medical electrode according to claim 64, wherein the sponge impregnated with solid gel is installed between the paste and a label to prevent the paste from oozing towards the side surface of the label.
81. An assembly for dispensing medical electrode comprising:
A carrier sheet mounted with pluralities electrodes in several rows; A pull strip releasably mounted on the carrier sheet to cover the tabs of the electrodes;
Wherein the carrier sheet is made up of bio degradable material and the pull strip is pulled upwardly to expose the electrodes in the multiple rows successively.
82. The assembly according to claim 81, wherein the bio degradable material is a naturally available material.
83. The assembly according to claim 82, wherein the bio degradable material is a leaf material.
84. The assembly according to claim 81, wherein the carrier sheet is made up of Areca Catechu Linn palm leaf plates.
85. The assembly according to claim 81, wherein the carrier sheet is made up of bio degradable plastic material.
86. The assembly according to claim 81, wherein the carrier sheet is made up of non petroleum based plastic material.
87. The assembly according to claim 81, wherein the carrier sheet is made up of starch based plastic material.
88. The assembly according to claim 81, wherein the electrodes are mounted in areas which are marked with an icon of an organ in human body, on the carrier sheet