Double-sided electrode pad

Abstract

To provide an inexpensive double-sided electrode pad assembly that eliminates localized heating and unwanted hot spots. [Solution] A double-sided electrode pad assembly (10) is configured to be placed on a patient's skin and includes an upper conductive gel layer (B), a middle conductive layer (C) comprising a highly conductive foil, a highly conductive plastic film, or a gel with highly conductive particles suspended therein, and a lower conductive gel layer (D). The upper and lower conductive gel layers comprise hydrogel, silicone, or hydrocolloid. Removable upper and lower protective liners (A, E) are disposed on the upper and lower conductive gel layers. The upper and lower protective liners have larger surface areas compared to the upper conductive gel layer, the middle highly conductive layer, and the lower conductive gel layer. The middle highly conductive layer has a smaller surface area compared to the upper and lower conductive gel layers, allowing the outer edges of the upper and lower conductive gel layers to extend beyond the outer edges of the middle highly conductive layer.

Description

[Technical field]

[0001] Cross-reference to related applications

[0001] This PCT International Application claims priority to U.S. Patent Application No. 15 / 415,621, filed January 25, 2017, which claims priority to U.S. Provisional Patent Application No. 62 / 287,393, filed January 26, 2016, the contents of which are incorporated herein by reference. FIELD OF THEINVENTION

[0002] The present invention relates generally to electrodes. More particularly, the present invention relates to double-sided electrodes. Regarding pads. [Background technology]

[0002]

[0003] In the prior art, electrical stimulation electrodes are taught in U.S. Patent No. 6,438,428, issued Aug. 20, 2002, which is incorporated herein by reference in its entirety. Referring now to FIG. 4, an exploded view of an electrical pad 40 is shown. Each conductive pad 40 includes a cover electrically conductive gel adhesive layer 42, a current control medium 50, and a conductive gel bottom adhesive layer 56. As seen in FIG. 4, all of these layers terminate at the same circumferential location. These electrodes 40 are typically used with a garment or brace that helps hold the electrodes 40 in place, as taught in the '428 patent. When the electrodes 40 are not in use, they can be stored for later use. The problem with this design is that the edges of the layer 50 can come into contact with the user / patient's skin during use. This can then lead to localized heating, or undesirable hot spots. Summary of the Invention

[0003]

[0004] Next, in the prior art, U.S. Patent No. 6,571,115, issued May 27, 2003, teaches a compression garment facilitation for the use of medical electrodes, the entire contents of which are incorporated herein by reference. Referring now to FIG. 14, it is shown how the current control medium no longer reaches to the edge, but instead has a border section disposed around the periphery. This eliminates localized heating and unwanted hot spots, since there is a peripheral border area of ​​low conductivity for the current control medium layer. However, this adds cost to the electrode structure due to the additional printing of conductive patterns.

[0004]

[0005] Thus, there is a need for improved electrodes which overcome the shortcomings of the prior art. The present invention fulfills these needs and further provides other related advantages.

[0006] An exemplary embodiment of the present invention is a double-sided electrode pad assembly configured to be placed on a patient's skin, the double-sided electrode pad assembly including an upper conductive gel layer, a middle conductive layer including a metal foil layer, a graphite layer, or any highly conductive current distribution media, and a lower conductive gel layer, the middle conductive layer being disposed between the upper and lower conductive gel layers.

[0005]

[0007] In other exemplary embodiments, the upper conductive gel layer may be 5 to 50 mils thick, and the upper conductive gel layer typically is about 20 mils thick. The upper conductive gel layer may include a hydrogel, a silicone, or a hydrocolloid.

[0006]

[0008] In other exemplary embodiments, the intermediate conductive layer may be 0.1 to 10 mils thick, and the intermediate conductive layer is typically about 1 mil thick. The intermediate highly conductive foil layer may include aluminum, tin, graphite, graphene, or any highly conductive material.

[0007]

[0009] In other exemplary embodiments, the lower conductive gel layer may be 20 to 120 mils thick, or the lower conductive gel layer may typically be 40 mils thick. The lower conductive gel layer may include a hydrogel, a silicone, or a hydrocolloid.

[0008]

[0010] In another exemplary embodiment, a removable upper protective liner may be disposed over the upper conductive gel layer, the upper protective liner having a larger surface area compared to the upper conductive gel layer, the middle conductive layer, and the lower conductive gel layer. Additionally, a removable lower protective liner may also be disposed over the lower conductive gel layer, the lower protective liner having a larger surface area compared to the upper conductive gel layer, the middle conductive layer, and the lower conductive gel layer.

[0009]

[0011] In other exemplary embodiments, the upper conductive gel layer may have a smaller surface area compared to the middle conductive layer, allowing the outer periphery of the middle conductive layer to be disposed beyond the edge of the upper conductive gel layer, and the lower conductive gel layer may have a larger surface area compared to the middle conductive layer, allowing the outer periphery of the lower conductive gel layer to be disposed beyond the outer periphery of the middle conductive layer.

[0010]

[0012] In other exemplary embodiments, the upper conductive gel layer and the intermediate conductive layer may have approximately the same surface area size, with the lower conductive gel layer having a larger surface area as compared to the upper conductive gel layer and the intermediate conductive layer, allowing the peripheral edge of the lower conductive gel layer to be disposed beyond the edges of the upper conductive gel layer and the intermediate conductive layer.

[0011]

[0013] In other exemplary embodiments, the intermediate conductive layer may have a smaller surface area compared to the upper and lower conductive gel layers, allowing the peripheral edges of the upper and lower conductive gel layers to be disposed beyond the peripheral edge of the intermediate conductive layer.

[0012]

[0014] In other exemplary embodiments, the intermediate conductive layer may include indicia. The indicia may be embossed into the intermediate conductive layer. The indicia may be laser etched onto the intermediate conductive layer. The indicia may be printed onto the intermediate conductive layer.

[0013]

[0015] In other exemplary embodiments, the intermediate conductive layer may include multiple individual intermediate conductive layers disposed between upper and lower conductive gel layers.

[0016] In other exemplary embodiments, at least one cutout may be formed in the middle conductive layer. The at least one cutout may be formed in either the upper or lower conductive gel layer. The at least one cutout may be similarly formed in the upper conductive gel layer, the middle conductive layer, and the lower conductive gel layer. The cutout may include a circular, square, rectangular, triangular, oval, ellipse, quatrefoil, curvilinear triangle, trapezoid, rhombus, kite, pentagon, hexagon, heptagon, octagon, nonagon, decagon, parallelogram, or crescent shape.

[0014]

[0017] In another exemplary embodiment, the electrode may include at least one ink pattern disposed on an intermediate conductive layer, the at least one ink pattern being a conductive layer. In another embodiment, the conductive foil or The conductive plastic film may comprise at least two materials with different resistivities. Alternatively, suspended conductive particles in a gel layer may comprise at least two materials with different resistivities. As can be seen, all of these are suitable for use in the present invention. 1 is an embodiment of a structure that can be used to control current distribution in a semiconductor device. [Brief description of the drawings]

[0015]

[0018] The accompanying drawings illustrate the invention. In such drawings: [Figure 1] FIG. 1 is a cross-sectional view of an exemplary overall electrode of the present invention. [Diagram 2] FIG. 2 is a cross-sectional view of another exemplary overall electrode of the present invention. [Diagram 3] FIG. 3 is a cross-sectional view of yet another exemplary overall electrode of the present invention. [Figure 4] FIG. 4 is a perspective view of layer C with embossed indicia. [Diagram 5] Figure 5 is a perspective view of both sides of layer C on which the indicia were laser etched or printed. [Figure 6] FIG. 6 is a cross-sectional view of the exemplary electrode of FIG. 3, now placed on a patient. [Figure 7] FIG. 7 is a perspective view of an exemplary electrode of the present invention as it appears on a patient's forearm. [Figure 8] FIG. 8 is similar to FIG. 7, but now shows multiple electrodes placed on a patient's forearm with probes for selectively activating certain electrodes. [Figure 9] FIG. 9 is a perspective view of an electrode of the present invention in stimulated and unstimulated states. [Figure 10] FIG. 10 is a top view of another embodiment of the present invention showing that the electrode includes multiple sections and can also include notches. [Figure 11] FIG. 11 is a top view of yet another embodiment of the present invention illustrating that the electrode can include multiple sections and cutouts of various sizes and shapes. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016]

[0030] FIGURE 1 is a cross-sectional view of a novel embodiment of the present invention's double-sided electrode pad assembly 10. FIGURE 1 is not drawn to scale and is drawn at a significant thickness in order to easily convey the concepts and teachings of the present invention.

[0017]

[0031] Layer A is a protective liner that is removed before the electrode itself is utilized. Layer A is fairly large in surface area (i.e., diameter or width of the electrode) so that it extends beyond the other active layers B, C, and D. This allows for easy removal of layer A when the electrode itself is to be utilized. Layer A is typically a translucent blue silicone liner of medium density polyethylene 2-3 mils thick.

[0018]

[0032] Layer E is also a protective liner that is removed before the electrode itself is used. Layer E may be made of polyester (Mylar) or other suitable liner materials known to those skilled in the art. Layer E is also made wide, typically 2-5 mils thick, to facilitate placing a silicone coating over the skin-side gel when the electrode 10 is not in use. The Mylar is often colored or has instructions printed on it to make it visible if dropped on the floor, thus preventing the slippery silicone from falling off.

[0019]

[0033] Layers A and E protect the electrode 10 during shipping and storage. They also prevent dust, particles, and other contaminants from contaminating the electrode 10. They also prevent the adhesive gels B and D from adhering to other objects. Layers A and E serve to prevent the electrode 10 from drying out, since layers B and D are typically conductive hydrogel layers that may dry out if left uncovered. Thus, even after the electrode 10 itself has been used, layers A and E can be reused to further protect the electrode 10 until the next use of the electrode.

[0020]

[0034] Layers B and D are conductive gels. In this embodiment, layer B is approximately 20 mils thick, but can be made in thicknesses ranging from 5 to 50 mils. Layer D is approximately 40 mils thick. Although the thickness of the conductive gel of layers B and D is preferably about 100 μm, it can be made in a range of thicknesses from 20 to 120 mils. The conductive gel of layers B and D can be made of any conductive adhesive material such as, by way of example, hydrogels, silicones, hydrocolloids, etc. See prior art medical electrodes such as those taught in U.S. Patent No. 7,346,380, issued March 18, 2008, which is incorporated herein by reference in its entirety.

[0021]

[0035] In the prior art U.S. Patent No. 6,571,115, the current control medium 50 was a printed carbon film which was expensive to produce. In the present invention, layer C is a conductive metal foil, a graphite layer, or any other highly conductive medium. The thickness of layer C can be about 1 mil, or in the range of 0.1 to 10 mils. Using 1 mil aluminum foil for layer C significantly reduces the cost of the overall electrode assembly 10.

[0022]

[0036] As can be seen in FIG. 1, layer B has a smaller surface area (i.e. its diameter or width / total length of the electrode) compared to layer C, which can be seen in oversize one dimension (O1). Layer C then has a smaller surface area compared to layer D, which can be seen in oversize two (O2). Layers A and E are also made wider compared to layers B, C, and D, which can be seen in oversize three (O3). In this embodiment, the different surface areas of the active layers prevent and / or reduce the likelihood of edge burning or undesirable localized heating. Layer B can be any size (O1) smaller than layer C, while layer D is preferably 1 / 4 inch longer along the edge than layer C, but can be oversized in the range of 1 / 8 inch to 5 / 8 inch (O2). In one embodiment, layers A and E can be longer than layer D by 1 / 4 inch or more (O3), with a minimum oversize of 1 / 8 inch or more.

[0023]

[0037] As shown in Figure 1, layer B has a small surface area compared to layers C and D. However, in other embodiments, layer B may be the same size as layer C, in which case layer D is made larger (only O4) compared to layers B and C. This embodiment is best shown in Figure 2.

[0024]

[0038] Alternatively, layer B may be the same size (surface area) as layer D, in which case layers B and D are made large compared to layer C (O5). This embodiment is best shown in Figure 3. In all of these embodiments, the possibility of edge burning or any unwanted localized heating is reduced and / or eliminated.

[0025]

[0039] FIG. 3 also teaches a significant safety advantage to the use of the electrode 10. In some situations, the electrode may be placed upside down by the user / patient. This may occur due to unintentional error during use, either because the person is tired or unable to pay close attention. FIG. 3 shows that both layers B and D are made larger compared to layer C. This unique structure then allows the electrode in FIG. 3 to be placed upside down without creating hot spots or undesirable localized heating.

[0026]

[0040] As can be seen and understood in Figures 1-3, it is no longer necessary to use a printed carbon film with no printed borders. Rather, now a conductive foil can be used instead, such as a metal foil, graphite foil, or any other highly conductive inexpensive medium. For example, a conductive plastic film layer can now be used with the present invention. Additionally, a hydrogel layer can also be used, which contains suspended metal, graphite, graphene, or other highly conductive particles. The conductive particles can be suspended not only within the hydrogel, but also within the silicone or hydrocolloid gel layer.

[0027]

[0041] 4, in other embodiments, layer C can be embossed with various indicia 12 that may be useful to a user or manufacturer. For example, layer C can be embossed with a logo or trademark 12 to help identify the manufacturer of the electrode. Or layer C can be embossed with various instructions to assist the user in utilizing the electrode 10. In other embodiments, embossing of layer C can be performed when layer C has a thickness of about 1 mil, although other thicknesses are possible. Typically layers B and / or D are at least partially light transmissive so that a user can see what is embossed on layer C, allowing such embossed structures to be visible.

[0028]

[0042] It is also possible to simultaneously cut notches 14 into layer C during the embossing step. For example, in manufacture, the embossing step 12 and the cut-out step 14 can be performed sequentially or simultaneously to speed up the manufacturing process.

[0029]

[0043] 5, in another embodiment, various indicia 16 can be laser etched into layer C. Laser etching can produce very precise and detailed information 16. Again, various logos and instructions can be laser etched directly into layer C.

[0030]

[0044] In other embodiments, various indicia 18 can be printed onto layer C. Printing can also produce very precise and detailed information.

[0045] As an example of the present invention, changing layer C from carbon film at $0.70 / LnFt (linear foot) to aluminum foil, now at $0.02 / LnFt, achieves a significant cost reduction (factor of 35). This material change, combined with the new oversized configuration taught in Figures 1-3, provides a significant cost reduction over the prior art. A significant improvement is obtained.

[0031]

[0046] 6 and 7, it is important to understand that while embodiments of the present invention may be used in conjunction with clothing or a protective wrap as in the prior art, they may also be utilized without such clothing or a protective wrap. For example, the electrode 10 of the present invention may be utilized with any electrical connection means 20 that conveys an electrical signal to layer B. The electrical signal then passes through layers C and D and ultimately to the skin 22 of the user / patient. Thus, the use of clothing or a protective wrap is not necessary to practice the embodiments of the present invention taught herein.

[0032]

[0047] FIG. 7 shows a more realistic perspective view of the electrode 10 placed on the forearm 24 of a user / patient.

[0048] Referring now to FIG. 8, a physical therapist may place multiple double-sided electrodes 10 on the skin as seen at the upper portion of the forearm, with the B and D layers being made wider compared to the C layers. Also, as shown in FIG. 8, near the wrist, the much larger B and D layers house multiple smaller C layers between them. As can be seen in FIG. 8, and with reference to FIGS. 1-3, there are multiple ways to configure the present invention for various electrodes. Thus, it will be understood by those skilled in the art that any of the electrode embodiments taught herein (FIGS. 1-3) may be used in the manner described above.

[0033]

[0049] Typically, muscle stimulation uses two electrode locations to induce the appropriate muscle contraction of the muscle between those electrode locations when stimulated. For example, one probe 26 may activate an electrode on the upper forearm while a second probe 26 may activate an electrode near the wrist. Thus, two probes 26 may be used to target a particular muscle for stimulation. The flesh can be activated. By moving the two probes 26 between the electrode pairs, the practitioner can quickly and accurately determine, by comparison, the optimum permanent electrode placement for the actual treatment electrodes. This is a similar concept to FIG. 6 of U.S. Patent No. 5,904,712, issued May 18, 1999, and FIG. 6 of U.S. Patent No. 6,038,485, issued March 14, 2000, both of which are incorporated herein by reference in their entireties.

[0034]

[0050] To help the reader better understand how the electrodes actually work, reference is made to FIG. 7 of U.S. Patent No. 8,473,072, issued June 25, 2013, and U.S. Patent No. 8,874,231, issued October 28, 2014. These patents are incorporated herein by reference in their entirety. This is also shown in the present invention as FIG. 9. FIG. 9 is a perspective view of an electrode 10 attached to a patient's forearm 24. In the upper view, the electrode is in an off state and is not transmitting any electrical signal. The patient's hand is shown in a clenched position. The lower view shows the electrode in an activated state, so the patient's hand is open. As will be appreciated by those skilled in the art, the electrode 10 can be configured to be placed along any other body part of the patient.

[0035]

[0051] The present invention can also be designed to incorporate various notches or voids that can be formed in any of layers B, C, or D. For example, FIG. 10 shows a view similar to FIG. 9 in U.S. Patent Publication No. 2007 / 0238944, which is incorporated herein by reference in its entirety. FIG. 10 shows a top view of another embodiment of an electrode 10 of the present invention, in which notches 28 are formed between four separately controlled electrodes. FIG. 11 of the present invention is also similar to FIG. 8 of the '944 patent publication. FIG. 11 shows that various notches 28 can be utilized. For example, a large rectangular notch 28 can separate the two electrode portions. Alternatively, multiple different shaped notches 28 can include circular, hexagonal, triangular, square, semicircular, etc. As one skilled in the art can appreciate, the present invention can be utilized in many of the ways that prior art electrodes were utilized. However, the present invention has lower manufacturing costs.

[0036]

[0052] Here, notches 28 or voids 28 in any of layers B, C, or D can be used to control the conductivity / resistivity of any such layers. For example, notches formed in layer C can be used to more precisely control the current distribution in layer C. Alternatively, a different non-conductive ink 28, or an ink 28 having a higher resistivity than layer C, can be screen printed or flood coated onto layer C. The notches 28 are a mechanical mechanism for controlling the current distribution, while the use of a less conductive ink 28 is more of an electrical mechanism for controlling the current distribution.

[0037]

[0053] In an effort to achieve even greater control over the current distribution across layer C, it is possible to use two (or more) materials with different resistivities. For example, layer C can include a graphite foil selectively cut and placed adjacent to an aluminum or tin foil. Graphite has a higher resistivity compared to either aluminum or tin. Similarly, when layer C is a gel layer in which conductive particles are suspended, conductive particles of two different materials can also be used. For example, graphite particles can be used in one location while aluminum or tin particles can be used in other locations. In this way, a lower cost and simpler alternative to prior art electrodes can be obtained while still providing more precise control over the current distribution across layer C.

[0038]

[0054] The electrodes 10 of the present invention can also be made in a variety of shapes, including round, square, elongated, and rectangular. It will also be understood that shapes include, but are not limited to, squares, triangles, ovals, ellipses, quatrefoils, curvilinear triangles, trapezoids, rhombus, kite shapes, pentagons, hexagons, heptagons, octagons, nonagons, decagons, parallelograms, crescents, and any other possible shapes, as the present disclosure is not limited to the shapes shown herein.

[0039]

[0055] It will also be understood that in the present invention, layer C is a highly conductive layer, while layers B and D are conductive. In other words, layer C is a layer that has a high conductivity compared to layers B or D. Also, the resistivities of the gel and the conductive foil are different. Typically, the resistivity of a foil is measured by a surface resistance test, whereas the resistivity of a gel is measured by a volume resistivity test. Typically, layers B and D have a volume resistivity greater than 100 ohm-cm, and layer C has a surface resistivity of less than 10 ohms. Layer C is more conductive than layers B and D. It will be seen that it is a layer.

[0040]

[0056] As an example of the present invention, the following measurements are applicable: Layer B: USB35 Gel, thickness 35 mil, volume resistivity 1233 ohm-cm, surface resistivity 6500, Layer D: USS35 gel, thickness 34 mil, volume resistivity 1450 ohm-cm, surface resistivity 8600; Layer C: Graphite, 5 mil thickness, surface resistivity 4 ohms, Layer C: Aluminum, 5 mil thickness, surface resistivity 0.22 ohms; Layer C: Tin, 2.5 mil thickness, surface resistivity 0.08 ohms.

[0041]

[0057] For further information, reference is made to U.S. Patent No. 7,769,473, issued Aug. 3, 2010, the entire contents of which are incorporated herein by reference.

[0042]

[0058] For further information, reference is made to U.S. Patent No. 6,038,464, issued March 14, 2000, the entire contents of which are incorporated herein by reference.

[0043]

[0059] As used herein, a mil is one thousandth of an inch or 0.001 inch (25.4 μm).

[0060] Although various embodiments have been described in detail for purposes of illustration, various modifications can be made to each without departing from the scope and spirit of the invention, and it is therefore intended that the invention not be limited except as by the appended claims.

Claims

1. A double-sided electrode pad assembly configured to be placed on the skin of a patient, comprising: an upper conductive gel layer having a volume resistivity greater than 100 ohm-cm; an intermediate conductive layer having a surface resistivity of less than 10 ohms; an underlying conductive gel layer having a volume resistivity greater than 100 ohm-cm; the intermediate conductive layer is disposed between the upper conductive gel layer and the lower conductive gel layer; the upper conductive gel layer and the intermediate conductive layer have diameters of approximately the same size, the lower conductive gel layer has a larger diameter compared to the upper conductive gel layer and the intermediate conductive layer, and a peripheral edge of the lower conductive gel layer is disposed beyond edges of the upper conductive gel layer and the intermediate conductive layer; Double-sided electrode pad assembly.

2. 2. The double-sided electrode pad assembly of claim 1, a double-sided electrode pad assembly, wherein the upper conductive gel layer is configured to contact an electrical connector for passing electrical current from the upper conductive gel layer, through the middle conductive layer, and through the lower conductive gel layer to the patient's skin.

3. 2. The double-sided electrode pad assembly of claim 1, A double-sided electrode pad assembly including a removable insulating upper protective liner disposed on the upper conductive gel layer, the upper protective liner having a larger surface area compared to the upper conductive gel layer, the intermediate conductive layer, and the lower conductive gel layer.

4. 2. The double-sided electrode pad assembly of claim 1, A double-sided electrode pad assembly including a removable insulating lower protective liner disposed on the lower conductive gel layer, the lower protective liner having a larger surface area compared to the upper conductive gel layer, the middle conductive layer, and the lower conductive gel layer.

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