Stimulation electrode
10173049 · 2019-01-08
Assignee
Inventors
Cpc classification
A61N1/0496
HUMAN NECESSITIES
International classification
Abstract
A skin electrode for stimulation comprising a superporous hydrophilic material having a first relaxed state and a second expanded state. In the second expanded state the superporous hydrophilic material is breakable to at least partly enclose at least one hair, and an electrode surface for electrically stimulating the skin by driving current from the electrode surface through the hydrophilic material to the skin comprising the at least one hair.
Claims
1. A skin electrode for stimulation comprising; a superporous hydrophilic material having a first state and a second expanded state, in the second state the superporous hydrophilic material is breakable to at least partly enclose at least one hair, and an electrode surface for electrically stimulating the skin by driving current from the electrode surface through the hydrophilic material to the skin comprising the at least one hair, wherein the superporous hydrophilic material comprises: 45.1% polymerized acrylamide, 1.5% polymerized acrylic acid, 32.6% polymerized sulfopropylacrylate potassium salt, 0.8% polymerized methylene bisacrylamide, and 20.0% inter-penetrating network former crosscarmelose sodium salt; or the superporous hydrophilic material comprises: 50.1% polymerized acrylamide, 1.7% polymerized acrylic acid, 36.2% polymerized sulfopropylacrylate potassium salt, 0.9% polymerized methylene bisacrylamide, and 11.1% inter-penetrating network former crosscarmelose sodium salt; or the superporous hydrophilic material comprises: 53.1% polymerized acrylamide, 1.8% polymerized acrylic acid, 38.3% polymerized sulfopropylacrylate potassium salt, 0.9% polymerized methylene bisacrylamide, and 5.9% inter-penetrating network former crosscarmelose sodium salt.
2. A skin electrode for stimulation according to claim 1, wherein the superporous hydrophilic material is breakable due to breakable crosslinks in the superporous hydrophilic material.
3. A skin electrode for stimulation according to claim 1, wherein the hydrophilic material has a volume swelling ratio of at least 2.
4. A skin electrode for stimulation according to claim 1, wherein an impedance of the hydrophilic material is substantially the same as an impedance of the skin.
5. A skin electrode for stimulation according to claim 1, wherein the hydrophilic material is configured to revert from the second expanded state to the first relaxed state by use of an acid.
6. A skin electrode for stimulation according to claim 1, wherein the hydrophilic material has a mechanical strength of at the most a mechanical compressional strength of hair.
7. A skin electrode for stimulation according to claim 1, wherein the hydrophilic material also conforms to a shape of the skin electrode.
8. A skin electrode for stimulation according to claim 1, wherein the electrode surface has at least one edge for retaining the hydrophilic material in contact with the electrode and the skin.
9. A skin electrode for stimulation according to claim 1, wherein the electrode is adapted to apply a direct current of 0.5-5 mA.
10. A skin electrode for stimulation according to claim 1, further comprising an anaesthetic agent.
11. A skin electrode for stimulation according to claim 1, wherein the hydrophilic material comprises the anaesthetic agent.
12. A skin electrode for stimulation according to claim 1, wherein the skin electrode is configured to be used and sized for transcranial direct current stimulation.
13. A skin electrode for stimulation comprising; a conductive electrode, a superporous hydrophilic material having a first state and a second expanded state, in the second state the superporous hydrophilic material is breakable to at least partly enclose at least one hair, and an anaesthetic agent for arrangement between the superporous hydrophilic material and skin of a stimulation area of a patient, wherein the superporous hydrophilic material comprises: 45.1% polymerized acrylamide, 1.5% polymerized acrylic acid, 32.6% polymerized sulfopropylacrylate potassium salt, 0.8% polymerized methylene bisacrylamide, and 20.0% inter-penetrating network former crosscarmelose sodium salt; or the superporous hydrophilic material comprises: 50.1% polymerized acrylamide, 1.7% polymerized acrylic acid, 36.2% polymerized sulfopropylacrylate potassium salt, 0.9% polymerized methylene bisacrylamide, and 11.1% inter-penetrating network former crosscarmelose sodium salt; or the superporous hydrophilic material comprises: 53.1% polymerized acrylamide, 1.8% polymerized acrylic acid, 38.3% polymerized sulfopropylacrylate potassium salt, 0.9% polymerized methylene bisacrylamide, and 5.9% inter-penetrating network former crosscarmelose sodium salt.
14. A skin electrode for stimulation according claim 13, wherein the anaesthetic agent is selected from a list comprising amylocaine, articaine, benzocaine, benzonatate, bupivacaine, butacaine, butanilicaine, chloroprocaine, cinchocaine, cocaine, dimethocaine, eucaine, etidocaine, hexylcaine, levobupivacaine, lidocaine, mepivacaine, meprylcaine metabutoxycaine, orthocaine, oxetacaine, oxybuprocaine, phenacaine, piperocaine, pramocaine, prilocaine, procaine, proparacaine, propoxycaine, quinisocaine, ropivacaine, trimecaine or tetracaine, and/or any combination thereof.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) These and other aspects, features and advantages of which examples of the disclosure are capable of will be apparent and elucidated from the following description of examples of the present disclosure, reference being made to the accompanying drawings, in which
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DESCRIPTION OF THE PREFERRED EMBODIMENTS
(8) Specific examples of the disclosure will now be described with reference to the accompanying drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the examples set forth herein. Rather, these examples are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The terminology used in the detailed description of the examples illustrated in the accompanying drawings is not intended to be limiting of the invention. In the drawings, like numbers refer to like elements.
(9) The following description focuses on an example of the present disclosure applicable to a skin stimulation electrode and in particular to skin stimulation electrode comprising a superporous hydrophilic material.
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(11) As illustrated in
(12) Superporous hydrophilic material 102 (porous hydrophilic crosslinked structures) have the ability to expand in aqueous environments up to 200-700 times their own weight in the dry state. The size, porosity, hydrophilicity and crosslink density are the major factors that control the swelling rate and swelling capacity of the superporous hydrophilic material 102. Depending on the application, the size and structural porosity of the superporous hydrophilic material 102 will be different. Superporous hydrophilic materials 102 are mostly characterized by their swelling and mechanical properties in different media. The swelling properties are measured by weight, volume and dimension at different time intervals (to obtain swelling rate) or at equilibrium (to obtain swelling capacity). In an example, the superporous hydrophilic material has a weight swelling ratio of at least 2 and/or the hydrophilic material has a volume swelling ratio of at least 2. By having a hydrophilic material with the weight swelling ratio of at least 2 and/or volume swelling ratio of at least 2, the superporous hydrophilic material 102 better breaks apart and thus creates a better enclosing of the hair 103. Preferably the expansion is in the range of 2-5 times in diameter in a single linear direction, calculated by use of Expansion=(Diameter wet)/(Diameter dry).
(13) Since superporous hydrophilic materials 102 are mostly based on hydrophilic and ionic monomers, their swelling and mechanical properties are generally sensitive to the type and nature of the swelling medium and as swelling ratio increases mechanical strength tends to decrease. Ionic strength, pH, salts, organic solvents and pressure are the most important factors. The superporous hydrophilic material 102 swelling properties (measured by volume (VSR) or weight (WSR)) generally increase with an increase in pH, and decrease in ionic strength, salt concentration, cation valence and pressure. In an example, the hydrophilic material is configured to revert from the second expanded state to the first relaxed state by use of an acid. By having the superporous hydrophilic material 102 to be reversed from the expanded state to the relaxed state, the superporous hydrophilic material 102 can be re-used.
(14) As discussed above, an increase in amount of crosslinks and/or an inter-network support structure increases the mechanical stability of the superporous hydrophilic material 102. In an example, the superporous hydrophilic material has a mechanical strength of at the most the strength of a hair, i.e. the compressional strength of the hair. When the superporous hydrophilic material 102 has at the most the mechanical strength of a hair, the superporous material breaks easier apart when contacting a hair exerting a counter force (compressional strength) against the superporous hydrophilic material, and thus creates an even better penetration and/or conformation of the superporous hydrophilic material 102 to the scuip/skin when pressed down by a user and/or the electrode itself, to the skin 104. In an example for achieving the desired mechanical strength the superporous hydrophilic material 102 comprises polymerized acrylamide 50.1%, polymerized acrylic acid 1.7%, polymerized sulfopropylacrylate potassium salt 36.2%, polymerized methylene bisacrylamide (serves as a bifunctional crosslinker) 0.9%, inter-penetrating network former crosscarmelose sodium salt 11.1%, or polymerized acrylamide 45.1%, polymerized acrylic acid 1.5%, polymerized sulfopropylacrylate potassium salt 32.6%, polymerized methylene bisacrylamide 0.8%, inter-penetrating network former crosscarmelose sodium salt 20.0%, or polymerized acrylamide 53.1%, polymerized acrylic acid 1.8%, polymerized sulfopropylacrylate potassium salt 38.3%, polymerized methylene bisacrylamide 0.9%, inter-penetrating network former crosscarmelose sodium salt 5.9%.
(15) The impedance of an electrode is vital for its performance characteristics in a device for recording and/or stimulation applications. Conventional metal electrodes have relatively high impedance compared to other types of coated electrodes at 1 kHz. This is mainly due to the rough surface topography which increases the available charge transfer area on the electrode. In one example, an impedance of the superporous hydrophilic material is substantially the same as an impedance of the skin. By matching the impedance between the superporous hydrophilic material and the skin, any electrical transfer loss from the superporous hydrophilic material to the skin is minimised. The better the impedance between different interfaces is, i.e. the interfaces; electrodesuperporous hydrophilic material 102, and superporous hydrophilic material 102skin, the lower any electrical transfer loss is to the skin of the patient and thus less power is lost from a current source to the skin 104. Hence, preferably the superporous hydrophilic material is matched with both connecting surfaces, i.e. electrode surface and skin. Normally the skin impedance lies within 10k-1M ohm depending on where on the body the impedance is measured and more specifically for the skull and skin impedance, the impedance lies according to our tests at 0.4 mA at 10 kOhm, at 0.3 mA at 13 kOhm and at 0.1 mA at 18 kOhm.
(16) In an example, the hydrophilic material also conforms to a shape of the skin electrode. By having the shape of the superporous hydrophilic material match the shape of the electrode, the current is evenly distributed over the surface area of the electrode 101 and consequently substantially with the same area to the skin 104 of the patient. In another example, as illustrated in
(17) In an example, the skin electrode for stimulation further comprising an anaesthetic agent. By having the electrode comprising the anaesthetic agent it is possible to apply higher currents to the skin of the patient since the patient will not feel any or as much discomfort as previously at the same currents without any agent. Compared to prior art wherein a combination of other types of hydrogel and anastethic agents have been used but were the hydrogel was more of solid hydrogel thus having the same problems as discussed above with worse electrical conduction to the skull/skin of the patient than with hydrogels of the current disclosure In another example, the superporous hydrophilic material 102 comprises the anaesthetic agent. By having the superporous hydrophilic material 102 comprising the anaesthetic agent it is only necessary to use one material on the electrode which speeds up the procedure and makes it easier for the user compared to having to apply two different components when using an electrode.
(18) In an alternative example, a skin electrode for stimulation comprises a conductive electrode and an anaesthetic agent for a stimulation of an area of a patient. By having an anaesthetic agent more current can be used without discomfort for a patient than without any anaesthetic agent. For example, the anaesthetic agent is selected from a list of agents, the list comprises amylocaine, articaine, benzocaine, benzonatate, bupivacaine, butacaine, butanilicaine, chloroprocaine, cinchocaine, cocaine, dimethocaine, eucaine, etidocaine, hexylcaine, levobupivacaine, lidocaine, mepivacaine, meprylcaine metabutoxycaine, orthocaine, oxetacaine, oxybuprocaine, phenacaine, piperocaine, pramocaine, prilocaine, procaine, proparacaine, propoxycaine, quinisocaine, ropivacaine, trimecaine or tetracaine, and/or any combination thereof.
(19) In one example, the use of an anaesthetic agent when performing electrical stimulation on skin of a patient for reducing sensation of the electrical stimulation. By using an anaesthetic agent more current can be used when stimulating the patient without additional discomfort for the patient.
(20) The above described electrodes is in one example a part of a system which includes a power controller and at least two electrodes, where the two electrodes are positioned on a head region of a subject, for example a user, and connected to the power controller through wires. One of the electrodes is a positive electrode, i.e., an anode, and the other electrode is a negative electrode, i.e. a cathode. The power controller includes an electrode drive arrangement that generates electric signals for driving the anode and the cathode to cause transcranial stimulation of the head region of the subject. In an example, the power controller includes a power source for providing a constant low current to the anode, which flows through the skull and brain to the cathode, thereby creating a circuit. By low current in relation to transcranial direct current stimulation is meant currents of 20 milliAmperes (mA) or less. In an example, the electrode is adapted to apply a direct current of 0.5-5 mA. Additionally in another example, the skin electrode is configured to be used for and sized for transcranial direct current stimulation. This allows the electrode to be designed in such a way that it can be easily used on a skull of the patient and with materials that has fewer restrictions than electrodes that are used in the body of the patient.
(21) In yet other alternative examples of an skin electrode, the skin electrode comprises a fluid access opening for separating said hydrophilic material and a fluid. The fluid access opening is openable for allowing hydrophilic material in contact with said fluid whereby said hydrophilic material assumes said second expanded state.
(22) In an example the skin electrode comprises a fluid chamber having said fluid access opening and containing said fluid.
(23) As discussed above, and now in greater detail a method of contacting (stimulating) skin with a skin electrode having an electrode surface and a superporous hydrophilic material having a first relaxed state and a second expanded state. The method comprises breaking the superporous hydrophilic material to at least partly enclose at least one hair in the second state to create contact between said electrode surface and said skin having the at least one hair. The user may in an example electrically stimulate the skin by driving current from the electrode surface through the hydrophilic material to the skin comprising the at least one hair.
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(26) Following is further examples of devices and methods according to the disclosure above used in an experiment for evaluating contact quality with the superporous hydrogel (SPH) electrodes according to this disclosure compared to a standard carbon-silicon electrode design.
Experiment 1
(27) The experiment was carried out with a Sooma tDCS device and three adult male subjects (#1, #2 and #3) participated in the study. Subject 1 was without any hair in the test area on the scalp and subject 2 and 3 had hair in the test area.
(28) Electrodes
(29) A standard silicon-carbon electrode (35 cm2 surface area) was used as reference and inserted into a sponge pouch soaked with 0.9% NaCl solution to provide improved electrical contact with subject scalp, as is a standard practice today when trying to improve conduction between a patient and an electrode.
(30) An example of an electrode 100 according to the disclosure is seen in
(31) Test Measurements
(32) The experiment used the following method for each electrode design and test subject:
(33) 1. The electrode was attached to the subject scalp in frontal locations.
(34) 2. A 2 minute preparation time was used to let the electrolyte form a contact between the scalp and the electrode
(35) 3. A measurement of contact was carried out with 0.3 mA current. Contact measurement was carried out for 1 minute to let the electrode-skin interface to stabilize. (Test 1)
(36) 4. After the contact was below 15k, the stimulator would let the operator to continue. The stimulation was started with 2 mA current
(37) 5. After one minute, the stimulation was set to pause and contact measurement was started again. The contact was let to stabilize for about 1 minute before measurement. (Test 2)
(38) Results
(39) Below are results from the two different tests in a tabular form for each subject and each electrode design.
(40) TABLE-US-00001 Test 1 (k) Test 2 (k) Subject Subject Subject Subject Subject 1 Subject 2 3 1 2 3 Standard 13 15 14 10 11 12 Combined 12 10 11 10 10 10 SPH 9 4 4 7 4 4
(41) Below are reported average resistance values and standard deviations for all test subjects. FIG. illustrate a chart of the average resistance values and standard deviations for all test subject from experiment 1.
(42) TABLE-US-00002 Average resistance (k) Std. dev. (k) Standard Combined SPH Standard Combined SPH Test 1 14 11 5.67 1 1 2.87 Test 2 11 10 5 1 0 1.73
Subject Sensations
(43) The subjects were asked to compare the sensation experienced with the standard design to sensations experienced with the two new designs: Subject 1 found no noticeable effect with combined design. SPH reduced greatly the tingling feeling on the stimulation site. Subject 2 reported slight reduction in tingling with the combined design. SPH greatly reduced the tingling sensation. Subject 3 found no noticeable effect with the combined design. SPH greatly reduced the tingling sensation.
Conclusions of the Experiment
(44) SPH provides superior contact, transfer of current and subject comfort when compared to the standard silicone-carbon electrode. This is particularly clear when the contact area is covered with hair (Subjects 2 and 3). Internal resistance of the carbon-silicone electrode appears to diminish the improvements by the SPH, as is seen in the results for the combined design.
Experiment 2
(45) Another experiment was carried out with a Sooma tDCS device and to test resistance of samples of standard swell super porous hydrogel (SPH) in a cylinder volume, SPH as a pad and conventional electrodes. The composition of the SPH material used in this experiment, and in the other examples and/or experiments of the disclosure, is;
(46) TABLE-US-00003 Content (% mass item/ mass hydrogel based on batch Item reaction composition) Standard Superporous hydrogel Polymerized acrylamide 50.1% Polymerized acrylic acid 1.7% Polymerized sulfopropylacrylate potassium salt 36.2% Polymerized methylene bisacrylamide 0.9% (note: serves as a bifunctional crosslinker) Inter-penetrating network former crosscarmelose 11.1% sodium salt Measurement of diameter at dry state versus after swelling to equilibrium indicates a diameter change of 3.1X (Dwet/Ddry). Note this represents swelling only in a single linear dimension. Low-Swell Superporous hydrogel Polymerized acrylamide 45.1% Polymerized acrylic acid 1.5% Polymerized sulfopropylacrylate potassium salt 32.6% Polymerized methylene bisacrylamide (note: 0.8% serves as a bifunctional crosslinker) Inter-penetrating network former crosscarmelose 20.0% sodium salt Measurement of diameter at dry state versus after swelling to equilibrium indicates a diameter change of 2.5X (Dwet/Ddry). Note this represents swelling only in a single linear dimension. High-Swell Superporous hydrogel Polymerized acrylamide 53.1% Polymerized acrylic acid 1.8% Polymerized sulfopropylacrylate potassium salt 38.3% Polymerized methylene bisacrylamide (note: 0.9% serves as a bifunctional crosslinker) Inter-penetrating network former crosscarmelose 5.9% sodium salt Measurement of diameter at dry state versus after swelling to equilibrium indicates a diameter change of 3.5X (Dwet/Ddry). Note this represents swelling only in a single linear dimension.
(47) TABLE-US-00004 RESISTANCE RESISTIVITY Voltage [V] [] [ .Math. m] MEAN STD MEAN STD MEAN STD (Over 30 min (Over 30 min (Over 30 min Figure Measurement session) session) session) FIG. 6a SPH standard swell 2.0 0.11 891 49 6.9 0.37 cylinder 1 FIG. 6b SPH standard swell 3.3 0.35 1510 161 6.9 0.74 cylinder 2 FIG. 6c SPH pad 1 2.0 0.13 905 88 NA (standard swell) FIG. 6d SPH pad 2 2.1 0.18 945 83 NA (standard swell) FIG. 6e SPH pad 3 1.7 0.01 791 4.5 NA (standard swell) FIG. 6g SPH high swell 4.3 0.08 1960 38 18.8 0.36 cylinder FIG. 6f SPH low swell 2.3 0.09 1050 41 6.5 0.25 cylinder FIG. 6h Electrode & sponge* 2.9 0.03 647 6.2 NA FIG. 6i Electrode & sponge 2 3.3 0.03 1500 13 NA
(48) As used herein, the singular forms a, an and the are intended to include the plural forms as well, unless expressly stated otherwise. It will be further understood that the terms includes, comprises, including and/or comprising, when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. It will be understood that when an element is referred to as being connected or coupled to another element, it can be directly connected or coupled to the other element or intervening elements may be present. Furthermore, connected or coupled as used herein may include wirelessly connected or coupled. As used herein, the term and/or includes any and all combinations of one or more of the associated listed items.
(49) The present disclosure has been described above with reference to specific examples and experiments. However, other examples than the above described are equally possible within the scope of the disclosure. Different method steps or a different order thereof than those described above may be provided within the scope of the disclosure. The different features and steps of the disclosure may be combined in other combinations than those described. The scope of the disclosure is only limited by the appended patent claims.