Patent Publication Number: US-2022211547-A1

Title: Statically charged and rechargeable scar modulation dressing

Description:
FIELD OF THE INVENTION 
     Aspects of the invention generally relate to medical devices and associated methods of manufacture and use, and more particularly to scar modulation dressings. Aspects of the invention relate to improving wound healing and improving scar maturation. 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
       The present invention is described in the detailed description which follows, in reference to the noted plurality of drawings by way of non-limiting examples of exemplary embodiments of the present invention. 
         FIG. 1  shows a first system in accordance with aspects of the invention. 
         FIG. 2  shows a second system in accordance with aspects of the invention. 
         FIG. 3  shows a third system in accordance with aspects of the invention. 
         FIG. 4  shows a fourth system in accordance with aspects of the invention. 
         FIG. 5  shows additional details of the systems in accordance with aspects of the invention. 
         FIG. 6  shows examples of some materials on the tribo series. 
     
    
    
     DETAILED DESCRIPTION 
     The particulars shown herein are by way of example and for purposes of illustrative discussion of the embodiments of the present invention only and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the present invention. In this regard, no attempt is made to show structural details of the present invention in more detail than is necessary for the fundamental understanding of the present invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the present invention may be embodied in practice. 
     Various methods to improve wound healing and improve scar maturation include: Electro therapy (Electric fields, potentials and currents); reduced tension on the scar; scar massage; water retention and gas exchange; antibacterial interfaces (e.g. Nano-silver layer) and sunlight protection. Electro-therapy for the treatment of wounds and scar formation often requires large components/devices, batteries, etc., and are not practical for everyday wear. Scar tension reduction has shown benefits for improving scar maturation but is often obsolete with the proper internal suturing techniques. 
     Silicone sheeting may also be used for scar treatment and management. Silicone sheeting and its effects have been well documented but the working principles and mechanisms still up for debate. Many believe that silicone sheeting provides the optimal moisture retention and pressure characteristics for scar management. Others have thought that silicone&#39;s affinity for static electricity build up may play a role in scar management. More specifically by improving the body&#39;s natural response to wound closure (i.e., the skin battery effect). 
     Massage has also been shown to improve scar management and is often recommended by many surgeon&#39;s post-operation to reduce scarring. 
     Aspects of the invention generally relate to medical devices and associated methods of manufacture and use, and more particularly to scar modulation dressings. Aspects of the invention relate to improving wound healing and improving scar maturation. 
     As shown in  FIG. 1 , a preferred embodiment involves applying a silicone sheet  10  (or a similar highly negative material on the triboelectric (“tribo”) series, e.g., teflon, PVC, Polypropylene, etc.) to the wounded or scar area  15  at the patient&#39;s skin  20 . A glove  25  (or other device) constructed out of a material that is highly positive on the tribo series (Such as Nylon, Wool, Silk or any other material on the positive side of the triboelectric series) is used to massage the wound or scar area. 
     This provides a dual benefit: 
     1) The contact of the glove/device  25  against the silicone sheeting  10  causes an electron exchange from the glove/device  25  to the silicone sheeting  10 . Upon separation the silicone will result in a highly negative charge state while the glove/device will result in a highly positive charge state. Since silicone is an insulator, a static charge build-up will occur as a result of this contact and separation. This build-up of electrons on the surface of the silicone  10  makes the silicone sheeting  10  highly negative in charge. When the silicone sheeting  10  is in adhesive contact with the skin  20 , which will act as a conductor due to its moisture and sodium content, the negatively charged silicone sheeting  10  will attract protons to move to the surface of the skin inducing a current  30 . This current  30  is thought to align fibroblast and influence cell migration to the wounded area. This is especially true when the wound  15  has closed and the wound&#39;s natural electrical potential has diminished throughout the later stages of scar maturation. 
     2) The physical massage of rubbing the glove/device  25  against the silicone sheeting  10  helps to soften the scar tissue and improve blood flow, amongst other benefits. 
     Static charge is created on the silicone sheeting when two insulators come into contact. The two insulators each have a different affinity to either attract or easily lose electrons based on how they are ranked in the tribo series. When two insulators that are on different ends of the tribo series come into contact electrons will be transferred. When separated one material will come away highly negative and the other highly positive. The electrons will stay static on the surface until they are grounded or dissipated into the air via moisture vapor (i.e. humidity). This will neutralize the charge of the surface. Often high moisture content in the surrounding area will allow electrons to “leak” to the surroundings. This is why static electricity builds up well in dry environments. 
     In experiments, the inventors have observed that the silicone sheeting  10  tends to have a steady state charge of around −0.02 kv before tribocharging. After tribocharging in the manner described herein (e.g., by contacting the silicone sheeting  10  with the glove/device  25 ), the inventors have observed the silicone sheeting  10  to have an average charge of about −2.0 kv but as high as −8.0 kv. In extremely dry environments higher charges can be achieved. Humidity has a large role in charge capacity and charge duration. In low humidity conditions charge can last for days. In high humid conditions a charge may last as short as a few minutes. 
       FIG. 2  shows an alternative embodiment to  FIG. 1  in accordance with aspects of the invention. In particular,  FIG. 2  shows a wound dressing system  100  comprising of a silicone sheet  110  (or a similar highly negative material on the triboelectric (“tribo”) series, e.g., teflon, PVC, polypropylene, etc.) applied to the wounded or scar area  115  at the patient&#39;s skin  120 . A device  135  (e.g., a stylus, wand, or other hand-held device), constructed out of a material that is highly positive on the tribo series (such as nylon, wool, silk or any other material on the positive side of the triboelectric series), held in the patients hand  145  and used to massage sheeting  110  on the wound or scar area  115 . During such charging, the silicone bottom layer  110  collects free electrons from the device  135  to build a static charge on the surface of the silicone bottom layer  110 . Surface modifications may be added to the materials to improve charge transfer efficiency. After tribocharging in the manner described herein, the charged silicone sheeting bottom layer  110  affects the skin  120  by creating a current  130  in a manner similar to that described with respect to  FIG. 1 , which results in improved healing for the wound  115 . Also, similar to  FIG. 1 , the massaging of the dressing  100  has the dual effect of: (1) tribocharging the silicone bottom layer  110 , and (2) physically massaging the wound  115 . 
       FIG. 3  shows an alternative embodiment in accordance with aspects of the invention. In particular,  FIG. 3  shows a wound dressing  200  comprising a Multilayer Composite Sheeting that is configured to create a triboelectric nanogenerator (TENG). In embodiments, the wound dressing comprises: a material highly negative based on the triboelectric series (such as silicone, teflon, PVC, etc.), as the bottom layer  210  (similar to sheet  10 ) with an upper layer  212 , comprised of a material highly positive on the triboelectric series (Such as nylon, wool, etc.), sealed around its edges and separated by a gas layer  214 . In a preferred embodiment, the upper layer is nylon. This embodiment allows the patient to massage the dressing  200  which will cause the upper layer  212  to make variable contact and separation with the silicone bottom layer  210  allowing a charge transfer due to tribocharging. During such charging, the silicone bottom layer  210  collects free electrons from the upper layer  212  to build a static charge on the surface of the silicone bottom layer  210 . The sealed gas layer  214  may be filled with nitrogen or other gases to reduce moisture content and charge equalization back to the upper layer  212 . Surface modifications may be added to the materials to improve charge transfer efficiency and charge retention sealed pockets in a grid pattern may be made in a sheet to cut to size. After tribocharging in the manner described herein, the charged silicone bottom layer  210  affects the skin  220  by creating a current  230  in a manner similar to that described with respect to  FIG. 1  and  FIG. 2 , which results in improved healing for the wound  215 . Also, similar to  FIG. 1  and  FIG. 2 , the massaging of the dressing  200  has the dual effect of: (1) tribocharging the silicone bottom layer  210 , and (2) physically massaging the wound  215 . 
       FIG. 4  shows an alternative embodiment in accordance with aspects of the invention. In particular,  FIG. 4  shows a wound dressing  300  comprising of sheeting  310  covering the wound area  315 . The sheeting  310  is then covered with an outer layer  312 . This outer layer covering  312  can be part of a patients clothing. The combination of the outer layer covering  312  and sheeting  310  is configured to create a triboelectric nanogenerator (TENG) when the patient moves or when massaged. In a preferred embodiment, the sheeting  310  is a material highly negative based on the triboelectric series (such as silicone, teflon, PVC, etc.) and the outer layer  312  is a material that is highly positive on the tribo series (such as nylon, wool, silk or any other material on the positive side of the triboelectric series). Movement will cause the outer layer  312  to make variable contact with the sheeting  310 . Massage with the patients hand  345  will also allow for variable contact with the sheeting. In embodiments, the wound dressing comprises: a silicone bottom layer  310  (similar to sheet  10 ) with an outer layer covering  312  and a separation  314  until motion of the patient or massage causes variable contact of the outer layer  312  with the sheeting  310 . This embodiment allows the patient to massage the dressing  300  through the outer layer  312  which will cause the outer layer  312  to make variable contact with the silicone bottom layer  310  allowing a charge transfer due to tribocharging. During such charging, the silicone bottom layer  310  collects free electrons from the outer layer  312  to build a static charge on the surface of the silicone bottom layer  310 . Surface modifications may be added to the materials to improve charge transfer efficiency. After tribocharging in the manner described herein, the charged silicone sheeting bottom layer  310  affects the skin  320  by creating a current  330  in a manner similar to that described with respect to  FIG. 1 , which results in improved healing for the wound  315 . Also, similar to  FIG. 1 , the massaging of the dressing  300  has the dual effect of: (1) tribocharging the silicone bottom layer  310 , and (2) physically massaging the wound  315 . 
     Additional aspects of embodiments of the invention may include one or more of: surface modifications to the silicone or nylon sheeting; silicone additives; and modified massage glove/device designs. These modifications may be made to increase the efficiency or effectiveness of the wound dressing. 
     In embodiments, surface modifications to the materials include one or more of: increased surface roughness; nano-textures; increased surface area; and charge traps—surface area traps that can trap electrons. Any of these can be applied to any one or more of: the silicone sheeting  10 ; glove  25 ; the silicone bottom layer  110 ,  210 ,  310 ; the upper layer  212 ; the device  135 ; and the outer sheeting  312 . 
     In embodiments, silicone additives include one or more of: thermochromic pigment to show temperature change; electrochromatic pigments to show charge state by changing colors; and UV inhibitor to block sunlight. Any of these can be applied to any one or more of: the silicone sheeting  10 ; the silicone bottom layer  110 ,  210 ,  310 . 
     In embodiments, modified massage glove/device designs may include: nano-hair (e.g., Suede leather)—increases contact surface area. This may be applied to the glove/device  25 . 
     Implementations as described herein provide an improvement in scar quality by providing a system that simultaneously provides a combination of both massage of the scar and the ability to have a more robust and rechargeable static electric charge. Massage with the glove/device/upper/outer layer serves two purposes. Direct massage directly improves the scar. Indirectly, it charges the silicone sheeting/bottom layer, which has a longer acting effect on the appearance of the scar. In embodiments, the material is slick to help with lowering friction and skin irritation during the massage. 
     In embodiments descried herein, the dressing may be composed of materials that are optimal for accepting a static charge and the slow release of that charge. The charge may or may not have a small magnetic field. The dressing may have an internal structure or components to control electron flow. The skin facing component may have filaments that touch or traverse the dressing. Alternatively, the charge may be created and stored using different materials that have same properties as filaments. Filaments within the dressing may go completely through the dressing and touch the skin and/or the wound. 
     In embodiments descried herein, the dressing provides scar therapy including: direct pressure via massage; ideal moisture vapor transmission rate via pore system&#39; and rechargeable static electric charged materials. Moisture vapor transmission rate (MVTR) of the dressing plays a role in the scar healing. Scar research has pointed to hydration of the wound as an important mechanism in causing fibroblasts and keratinocytes to synthesize and release collagen. MVTR is evident in the IV3000 dressing that the inventor has perfected for finger trauma. It is evident that too much moisture causes maceration of the skin which leads to infection and skin breakdown. Too much water loss leads to overactive cells. Therefore, ideal MVTR is important for scar development. 
     In an exemplary method of use of implementations of the invention, a statically charged dressing is placed over a wound. The dressing may comprise the sheeting  10 , the bottom layer  110 , the bottom layer  210 , or the bottom layer  310 . Pores may be arranged within the sheeting/bottom layer  10 / 110 / 210 / 310  and may be configured to optimize MVTR. As shown in the figures, a charging massage cloth or device is rubbed over the dressing sheeting/bottom layer  10 / 110 / 210 / 310  on the scar with some pressure, a few times per day. The charging massage cloth may be the glove  25 , device  135 , the upper layer  212 , or the outer layer  312 .  FIG. 5  shows different embodiments of the glove  25 . In one embodiment shown in  FIG. 5 , the glove  25 ′ is a full hand glove that has four fingers and a thumb. In another embodiment shown in  FIG. 5 , the glove  25 ″ is a one-finger glove that has only a single finger portion configured to receive one finger of a user. In another embodiment shown in  FIG. 5 , the glove  25 ′″ is a two-finger glove that has only two finger portions configured to receive two fingers of a user. Its composition helps to create a negative or positive charge into the dressing. As described herein, a static charged field is created in the dressing, and the composition of the dressing holds and discharges the charge into the skin around the wound in a controlled fashion. 
     Embodiments may include a capacitor-like dressing that includes porous holes to balance the moisture vapor transmission rate (MVTR). The capacitor-like dressing may represent any of the sheeting/bottom layer  10 / 110 / 210 / 310  and may have metallic or fiber inserts within the dressing to create, hold, or systematically discharge the charge. In some embodiments, the dressing may include an adhesive along the layer that touches the skin. In embodiments, the adhesive is applied only around a perimeter of the layer that contacts the skin, e.g., sheeting/bottom layer  10 / 110 / 210 / 310 . In this manner, the layer is adhered to the skin by the adhesive, while a central part of the layer directly contacts the skin and/or wound (i.e., without any adhesive at the location(s) of direct contact). 
     In embodiments the glove  25 , device  135 , upper layer  212 , or outer layer  312  comprises a low-friction charging cloth/material to be rubbed onto the dressing material to elicit a charge in the dressing. This material will serve as a mechanical massage aid. 
     In embodiments the materials should be soft, pliable, and may contain pores to create ideal moisture vapor transmission rate. The dressing may be configured to change color with the amount of charge left. For example, green when it has charge and is active, and red when it is without charge. 
     In embodiments, the sheeting/bottom layer  10 / 110 / 210 / 310  includes a channel or divot on the side that touches the skin, the channel or divot being filled with scar cream. 
     Additional aspects of the invention include manufacturing a system comprising the sheeting/bottom layer  10 / 110 / 210 / 310  and the glove  25 , device  135 , upper layer  212 , or outer layer  312  as described herein. Further aspects of the invention include a method of using the system comprising the sheeting/bottom layer  10 / 110 / 210 / 310  and the glove  25 , device  135 , upper layer  212 , or outer layer  312  as described herein. Even further aspects of the invention include providing instructions for using the system comprising the sheeting/bottom layer  10 / 110 / 210 / 310  and the glove  25 , device  135 , upper layer  212 , or outer layer  312  described herein. The instructions may be at least one of printed and video. 
     Additional aspects of the invention include manufacturing a dressing as described herein. Further aspects of the invention include a method of using the dressing as described herein. Even further aspects of the invention include providing instructions for using the dressing described herein. The instructions may be at least one of printed and video. 
       FIG. 6  shows examples of some materials on the tribo series. As used herein, a material that is highly negative on the tribo series is a material that is on the negative side of the series and that is closer to the negative end of the scale (e.g., silicone rubber) than to zero (e.g., cotton/steel), and material that is highly positive on the tribo series is a material that is on the positive side of the series and that is closer to the positive end of the scale (e.g., human hands) than to zero (e.g., cotton/steel). 
     It is noted that the foregoing examples have been provided merely for the purpose of explanation and are in no way to be construed as limiting of the present invention. While the present invention has been described with reference to an exemplary embodiment, it is understood that the words which have been used herein are words of description and illustration, rather than words of limitation. Changes may be made, within the purview of the appended claims, as presently stated and as amended, without departing from the scope and spirit of the present invention in its aspects. Although the present invention has been described herein with reference to particular means, materials and embodiments, the present invention is not intended to be limited to the particulars disclosed herein; rather, the present invention extends to all functionally equivalent structures, methods and uses, such as are within the scope of the appended claims.