WO2016014508A1

WO2016014508A1 - Device, system, method and kit for preparing skin

Info

Publication number: WO2016014508A1
Application number: PCT/US2015/041302
Authority: WO
Inventors: Jahn POWER
Original assignee: Full Power Aed, Llc
Priority date: 2014-07-25
Filing date: 2015-07-21
Publication date: 2016-01-28
Also published as: EP3171730A4; WO2017014794A1; CA2955940A1; US20170202334A1; EP3171730A1

Abstract

A skin treatment device having a substrate having a first surface and a second surface, and an adhesive layer covering at least a portion of the first surface of the substrate. When the adhesive layer is applied to the skin surface of a mammal and removed, hair is removed at the follicle. A skin treatment method is also disclosed.

Description

DEVICE, SYSTEM, METHOD AND KIT FOR PREPARING SKIN Field

The embodiments described herein focus on a device, system, method and kit for removing hair from the skin surface of a mammal, and for decreasing the impedance across the skin barrier. The device, system, method and kit may be used in connection with preparing the skin for contact with an electrode, as well as delivering drugs transdermally or iontophoretically. The embodiments enhance the efficiency of the transfer of electrical energy across the skin barrier making defibrillation or drug delivery more effective while using less power.

Background of the Invention

The skin barrier provides mammals with protection from harmful bacteria, the elements and the like. However, penetrating the skin barrier, at times, may be beneficial, even life saving. The application of electric current to reestablish normal heart rhythm and drug delivery by transdermal and iontophoretic means are examples of the benefits of penetrating the skin barrier in mammals.

Defibrillation is a common treatment given to one who is experiencing cardiac dysrhythmia, ventricular fibrillation or pulseless ventricular tachycardia which is referred to generally as "sudden cardiac arrest". The external defibrillation procedure involves applying electrodes in the form of a pair paddles or electrode pads to the skin in the chest area of a patient experiencing one of these conditions and applying electric energy to the electrode pads or paddles. The electrical energy moves through the electrode pads or paddles, across the skin barrier and into the patient's body to "restart" or return the heart to normal sinus rhythm. It should be noted that the term electrode, unless otherwise indicated, includes electrode pads.

There are four types of defibrillators. ALS (Advanced Life Safety) machines which are used by trained professionals. Automated External Defibrillator ("AED") which tend to be used by BLS (Basic Life Safety) certified or lay persons. There are also implantable and wearable

defibrillators. Our invention primarily pertains to the ALS and AED defibrillators and wearable. AED stations include a power source, pairs of electrodes and a set of instructions and other accessories that may be used by the person delivering the treatment. AED stations are commonly seen in airports, schools, office buildings and other public places. AED stations enable medical and non-medical personnel to deliver emergency defibrillation to a person in need until emergency response personnel arrive. Electrode pads are intended to be placed on the victim's bare chest and the AED unit analyzes the hearts rhythm to determine whether an electric shock should be delivered and the quantity of electrical current to be used When delivering electrical energy across the skin, whether for defibrillation or drug delivery, the skin itself it the greatest barrier. Hair, dead skin cells and debris on the skin surface contribute to impedance. Impedance is the total opposition to alternating current in a circuit. When delivering electrical energy across the skin barrier, if impedance is lowered, then there is less energy needed to cross the skin barrier and effectively deliver the energy. Thus, in the case of defibrillation, to effectively deliver the appropriate level of current across the skin barrier, the skin's surface should free of anything that can interfere with the defibrillator's performance. Impedance, in the form of hair, debris and skin lessen electrode pad to skin contact and can adversely affect defibrillation results.

The primary electrical impedance is the skin itself. It creates what is known as "physiologic artifact". Artifact is a noise and impedance that is noticed as an imperfect reading, such as with an EKG system, or with an AED system. This occurs, in part, because the epidermis refuses electrical current due to its dead skin cells lying on the surface. Skin has its own resistance registered in Ohms. Slightly abraded skin eliminates many of the dead skin cells on the skin surface and thus allows a more effective flow electrical current across the skin barrier. This optimizes the analysis and in the case of AEDs, enables a higher quality of diagnosis and electrical current to pass across the skin barrier.

The emergency kits by necessity need to be easy to understand and operate because they may be used by nonmedical personnel. In a situation where the patient's heart is stopped or beating irregularly, time is of the essence. In cases of male patients, application of the electrode pads may require the user to attempt to shave the chest hair quickly prior to the application of the electrode pads to the skin. This can often cause cutting of the skin because the razor is applied quickly to dry skin, and it may not be completely effective. If there is an incomplete contact with the skin, the current may arc at the point of contact causing burns to the skin and hair. Time is always critical for victims of sudden cardiac arrest. An AED system is sometimes operated by those not familiar with the equipment, and thus the user may be in a stressed state of mind. Those who try to provide help may not appreciate the importance of skin to electrode contact and may fail to adequately prepare the skin. Some patients have experienced burning on the electrode sites because the hair was heated to the point of combustion at the time of treatment. Other patients have died because the defibrillation process was ineffective due to the inability of the electrical energy to move across the skin barrier as a result of poor skin contact with the electrode pads.

It is worth noting that there is a balance between an effective system and method of preparing the skin to receive an electrode pad, and damaging the skin. If the system to remove hair and debris is too aggressive, the skin may be broken or bruised. In addition, if the system is less effective, contact between the skin and electrode pad will be less effective and the efficacy of defibrillation will be compromised. Numerous adhesive backed substrates have been developed for wound care and the like. These however focus on the ability to effectively adhere to the skin surface surrounding the wound without removing hair and causing the least discomfort or disturbance upon removal.

Two publications address hair removal for use with an AED. The first is US Publication

2005/0070963 to Wilson et al. describes a hair-removal apparatus for preparing a human torso for the use of an automated external defibrillator. The second reference is US Publication 2012/0029530 to Gunstream et al.

There is a need for a device, system, method and kits that includes a sufficient level of adhesive thickness so as to fully envelope the hair shaft upon application. There is also a need for a device, system, method and kit that prepares skin by removing hair at the follicle. There is yet a further need for a device, system, method and kit that substantially decreases the impedance level across the skin at the application site. These and other attributes of the preferred embodiments without the disadvantages of the aforementioned disclosures will be described in detail below. Brief Description of Drawings

Fig. 1 shows a plan view of the first embodiment described herein.

Fig. 2 shows a sectional view of the embodiment of Fig. 1.

Fig. 3 shows an enlarged side view of the embodiment of Fig. 1 in use.

Fig. 4 is a diagrammatic representation of the second embodiment described herein.

Fig. 5 A is a side view of the third embodiment described herein.

Fig. 5B is a top view of the third embodiment of Fig. 5 A.

Fig. 6 is a perspective view of the third embodiment of Fig. 5 A in use.

Detailed Description

First Embodiment

The first embodiment 10 is a pair of skin preparation pads shown in Fig. 1. The first

embodiment 10 includes a first pad 12 and a second pad 20 disposed on a divisible liner 14. The liner 14 has a first liner surface 16 and a second liner surface 18, as shown in Fig. 2. Pads 12, 20 are disposed on the first liner surface 16.

The second pad 20 is identical in construction to the first pad 12. The liner 14 is divisible in that it has a perforated seam 22 so as to separate the first 12 and second 20 pads for use which will be described in detail below. It is anticipated that first 12 and second 20 pads will be disposed on the divisible liner in an AED system for use to remove hair, debris from the skin and effectively abrade the skin so as to properly prepare the skin to receive the AED electrodes.

Pads 12, 20 are identical and thus will be described collectively. Each pad 12, 20 has an upper pad surface 24 and a lower pad surface 26, as shown in Fig. 2. The pad constitutes an assembly of different layers: a top layer 28, a label 30, and a substrate 32. The top layer 28 is a polymer laminate. The laminate layer 28 provides water resistance and prevents the adhesive layer from leaking out the opposite side of the substrate 32. The top layer 28 protects the label 30 which is located adjacent to the top layer. The label 30 is applied to a substrate 32 with adhesive. The label 30 has been designed to provide diagrammatic and written instruction to the user as to how to use the pads 12, 20 to prepare the skin.

A layer of adhesive 34 is applied to a portion of the substrate 32 along the lower pad surface 26. Preferably, the adhesive 34 is an acrylate adhesive having a thickness of between about 4 andlO mils. Preferably, the adhesive thickness must be at least about 8 mils. Preferably the substrate 32 is made of a nonwoven material having sufficient voids to receive the adhesive 34, and exhibit sufficient flexibility to make contact with hair and skin located beyond the initial contact point of the substrate. Further features and characteristics of the substrate will be discussed in more detail below.

A portion of the substrate 32 does not have adhesive 34 thereon and serves as a grip 36 during use, which will be described in detail below. The divisible liner 14 made of a paper, fiber, polymer or the like is located adjacent to the adhesive 34. As can be seen in Fig. 1, the first surface 16 of the liner is adjacent to the adhesive 34. The liner 14 preserves the adhesive 34 prior to use. The liner 14 is folded so that the pads are stacked on top of each other with the liner there between. In addition, the pads, 12, 20 and liner 14 may be hermetically sealed within a polymer bag 40 to preserve and protect the pads until they are used.

To use, the sealed bag 40 containing the pads 12, 20 is opened and the pads are removed. It is anticipated that the sealed bag containing the pads would be packaged in a manner that makes opening easy and quick. This may be accomplished by using a horizontal seal and a saw tooth cut on the top and bottom of the package. The horizontal seal and saw tooth cut are designed so as to tear when a small amount of pressure is applied. In this fashion, the bag would be easily opened by those who may not have significant strength in their arms and hands, such as an older person, or someone who is disabled. The bag 40, with this design has been tested to be opened, the pads are applied to the skin and removed in less than 15 seconds.

The pads 12, 20 are separated at the liner 14 or removed from the liner without separating the liner. For purposes of illustration, each pad will be described separately. However, the order of placement of the pads onto the skin is irrelevant. Once the pad 12 is removed from the liner 14, it is placed on the skin surface at the location shown on the label. For example the first pad 12, may be placed in the patient's upper right chest area. With the liner 14 removed, the adhesive 34 is able to effectively contact the skin surface, and all of the hair in the contact area. It is preferred that the user or operator apply manual pressure to the pad 12 before removing it so as to further enable the adhesive to effectively contact the skin and hair in the area. The adhesive 34 is able to sink and spread between the hairs and to contact the entire hair shaft located about the skin surface. By fully enveloping each hair shaft, the adhesive is able to effectively grip the hair and maintain its hold during removal which is discussed in detail below.

After pressure is applied, the user grasps one of the grips 36 and pulls quickly and firmly in a motion away from the skin surface, essentially at a 180 degree angle from the adhesive/skin barrier, as shown in Fig. 3. Arrow A represents the desired direction of the pull force. The pull force on the pad 12 causes the pad to pull away from the skin surface. As the pad 12 is removed from the skin surface, the adhesive 34 maintains its grip on the hairs it has enveloped so as to pull the hairs by their root from the follicle. As can be seen in Fig. 3, the hair shaft above surface makes contact with the adhesive at the point of removal and at the adhesive/skin barrier. The length of the hair shaft contacts the adhesive so that the adhesive has a greater grasp on the hair as it is pulled by its root from the follicle.

Applicant determined that by enveloping or encapsulating the length of the hair shaft within the adhesive, the device, when removed from the skin surface, was able to effectively pull the hair by the root out of the hair follicle completely. By removing the hair in this manner, the entire hair strand was removed from the skin. This adds to the impedance drop across the skin and considerably slows hair regrow at the site. These advantages will be discussed in more detail below.

In addition, to the removal of hair as described above, with the pad 12 removal from the skin surface, oil and debris along the skin surface are also removed. Because the dead skin cells are removed by the adhesive 34, newer skin cells are exposed to the skin surface which is referred to as abrasion.

The application and removal of the pad 12 may also causes a histamic response at the application site. The histamic response is present in the form of acute inflammatory response. The body dilates the blood vessels, releases plasma and leukocytes to the surface of the skin to protect it. This inflammatory response is cause by mechanical irritation from large amount of hair being removed quickly. Dry skin is a very poor conduit. The histamic response delivers liquid to the affected skin and further enhances the transfer of electrical energy across the skin barrier This process is repeated for the second pad 20 which is placed along the patient's left side as shown in the illustrated instructions. After both pads 12, 20 have been used to prepare the skin, the skin is ready to receive the AED electrode pads which will deliver electrical energy across the skin in an effort to restore the patient's normal heart rhythm. The locations where the pads 12, 20 were applied are referred to as the application sites.

Second Embodiment

A second embodiment 42 is disclosed in Fig. 4. This embodiment 42 is an AED system and includes the skin preparation pads 12, 20 of the first embodiment 10 as used in connection with an AED device 44. The AED device 44 includes a housing 46, a power source, such as a battery (not shown), an activation switch or button 48, a screen 50, and a pair of electrode pads 52. The electrode pads 52 are electrically connected to the AED device by cables 54.

In use, where the AED electrode pads 52 are to be placed, the skin is prepared the same as described above for the first embodiment 10. The user places the pads 12, 20 at the appropriate locations on the patient's chest and subsequently removes each. After the skin at both application sites has been prepared, the user places the electrode pads 52 at each preparation site and turns the power to the AED device 44 on. This may be achieved by turning the switch 48 to the "on" position. Once the AED device 44 is powered on and the electrode pads 52 are in effective contact with the skin, the device will take a reading of the heart rhythm. If the AED device 44 determines that the heart is in need of treatment, the device will deliver an amount of electrical energy through the skin and into the chest cavity in an effort to return the heart to its normal rhythm.

An effective contact between the skin surface and the electrode pads 52 is a critical factor in ensuring success with using the AED device 44. By using the pads 12, 20 the hair is effectively removed at the follicle, and dead skin cells and debris are also removed. By removing hair at the root from the follicle, the impedance is substantially diminished. This results in the ability of the AED power source 46 to more accurately deliver the precise amount electrical energy to the chest cavity and restore the heart to its natural rhythm. A cleaner application site also prevents any skin or hair burns because it decreases the chance of electrical arcing due to ineffective contact between the skin and electrode pad. In addition, by removing hair at the root and thus substantially decreasing the impedance, the AED device 44 is also able to more accurately diagnose the heart behavior and deliver a more effective dose of energy without the interference of hair, dead skin cells and the like.

Third Embodiment

A third embodiment 56 is directed to a hair removal device and is disclosed in Figs. 5A and 5B and Fig. 6. The third embodiment 56 includes a rectangularly shaped substrate 58 having first 60 and second 62 surfaces. An adhesive layer 64 is applied to a portion of the first surface 60 of the substrate 58. The remaining area of the first surface 60 without adhesive forms a grip 66 which will be discussed in more detail below. A removable liner 68 rests on the adhesive layer 64 and protects it prior to use. In use, the removable liner 68 on the third embodiment 56 is removed to expose the adhesive layer 64. The substrate 58 is placed on the surface of the skin in an area in which hair is to removed, such as a woman's leg, as shown in Fig. 6. The substrate 58 is placed so that the adhesive layer 64 is in contact with the skin surface. A moderate amount of pressure is applied to the substrate 58 to ensure that the adhesive layer 60 envelopes the hairs on the skin surface and any air pockets are removed. The user grasps the grip 66 portion of the substrate 58 and pulls away from the skin surface in a direction 180 degrees from the adhesive/skin barrier. As the substrate 58 is pulled from the skin surface, the hair shaft enveloped by the adhesive, is pulled at the root from its follicle and removed in its entirety from the skin.

For cosmetic applications, it is envisioned that a number of different substrate 58 strips may be needed to remove the hair from a leg. For surgical preparation application, a single substrate 58 may be used to prepare the skin for surgery. It is further envisioned that the substrate 58 in this third embodiment 56 may be shaped differently to accommodate different cosmetic and medical applications. For example, if the patient is undergoing surgery that has a particular incision shape, the substrate may be shaped to accommodate the incision shape. In another example, if the substrate is used for cosmetic applications, it is envisioned that the substrate may be shaped to accommodate hair removal located in certain places on the body, such as the eyebrow, upper lip, bikini line, etc.

It is further envisioned that the hair removal device of the third embodiment 56 may be equally applicable to other mammals besides humans. It is envisioned that the third embodiment 56 may be used to remove hair, and/or fur, from a mammal such as a dog or cat prior to undergoing surgery as discussed above for humans. In addition, the third embodiment 56 may be equally applicable for surgical site preparation for mammals since many mammals have hair and/or fur that grow at a substantially thicker rate. Removal of such hair and/or fur from the surgical site will provide a cleaner site that is less likely to become infected since no hair or fur is trapping or holding bacteria, and it is more comfortable for the mammal as the fur or hair grows in at a slower rate and causes less irritability to the skin. The embodiment 56 may be used on any mammal where hair or fur needs to be removed.

Applicant asserts that the embodiments described herein would be applicable on any mammal having hair, fur, pelage, wool or other soft coating growing out of the skin from follicles or the like. Moreover, while applicant refers generally herein to hair and human skin, applicants notes that term "hair" equally applies to fur, pelage, wool or other soft coating growing out of the follicle of a mammal.

It is also envisioned that a device similar to the third embodiment 56 would be applicable as a skin preparation device for the delivery of drug. Drug delivery may occur through transdermal or iontophoresis. Development Factors

Applicant will now address the various factors involved in the development of the embodiments described herein and the factors in determining the selection of materials and specifications that resulted in the devices, systems, methods and kits described. As applicant developed the embodiments, it was determined that both the adhesive and the substrate needed to have certain properties in order for the device as a whole to work effectively and remove hair from the follicle.

It was further determined that effective removal of hair at the root from the follicle, as well as removing dead skin cells and debris, and abrading the skin contributed to decreasing impedance across the skin barrier.

A study was conducted by J.W. Bissing and R.E. Kerber from the University of Iowa analyzing the effects of shaving chest hair and impedance. The study, entitled "Effect of Shaving the Chest of Hirsute Subjects on Transthoracic Impedance to Self Adhesive Defibrillation Electrode Pads", was published online in the American Journal of Cardiology on August 16, 2004, Vol. 86 (5), pp. 587-589. The study is incorporated herein in its entirety. The study was done on 9 adult hirsute males. The initial average impedance was found to be 163 ohms. This is the same as that found in applicant's studies. The results indicated that by shaving the chest the impedance decreases by about 35%. As can be seen from the data provided below, applicant was able to achieve a drop in impedance by as much as about 90%.

A substantial decrease in the impedance across the skin barrier results in a more efficient transfer of energy through the skin, requires less electricity to enter the patient's body and less energy drain on the system. In the case of an AED, the need for less energy may result in a smaller battery, ability to recharge more quickly and the ability to more accurately diagnose the heart condition of a patient prior to treatment. The decrease in impedance across the skin barrier in any other defibrillation device results in a more accurate reading of the device and a more efficient transfer of electrical energy across the skin barrier.

Also, the application and removal of the embodiments may result in a localized histaminic response. The histaminic response is present in the form of acute inflammatory response. The body dilates the blood vessels, releases plasma and leukocytes to the surface of the skin to protect it. This inflammatory response is cause by mechanical irritation from large amount of hair being removed quickly. Dry skin is a very poor conduit. The histaminic response delivers liquid to the affected skin and enhances the transfer of electrical energy across the skin barrier. Adhesive

The adhesive thickness is important in achieving efficacy and thus decreasing impedance.

Applicant determined that a substantially thick layer of adhesive was needed in order to achieve hair removal at the follicle. This is due to the fact that mammalian hair grows in layers. When a thin layer of adhesive is applied to the skin, only the outermost hairs are able to make contact with the adhesive and thus are the only ones to be removed. In initial tests conducted by applicant, when the adhesive was pulled away from the skin, the hairs in contact were removed but only at the skin level and not at the follicle. In some cases, the hair was broken along the shaft at the point of contact with the adhesive. The application of a thin layer of adhesive also left the hairs closer to the skin surface completely intact. And it did not effectively remove dead skin cells or debris because the adhesive was not able to penetrate effectively onto the skin surface. Applicant determined that a thicker layer of adhesive is able to sink deeper into the skin surface and envelope most of the hair, including those closest to the skin surface.

Applicant further observed that when the adhesive layer was too thick (greater than about 32 mils) it was found that the adhesive would not pull away from the skin with the substrate. Rather with an excessively thick layer of adhesive, the adhesive would pull apart from itself and leave some on the skin surface when the substrate/adhesive assembly is removed from the skin. In addition, applicant observed that with an excessively thick layer of adhesive, the adhesive would ooze from the sizes of the assembly and not remain below the lower surface of the substrate. In addition, it was determined that when the adhesive layer is of a certain viscosity, it remains flexible against the substrate yet envelopes and pulls the hairs out of the skin from the follicle. The wettability (wet out) of the adhesive was also a factor in achieving effectiveness. The wettability of the adhesive allowed the adhesive to more effectively surround the hair shaft and remove the hair at the follicle and not at the skin surface. Therefore the adhesive must be soft enough and be able to flow to achieve optimum skin adhesion and hair shaft envelopment.

In addition, when hair is removed at the root from the follicle, the regrowth of that hair will occur later in time than one where the hair is removed at the surface. Hair removed at the surface will begin to regrow immediately and new hair growth (stubble) can begin to appear in a matter of hours. Hair regrowth at the follicle will require a substantially longer period of time before it is seen on the skin surface, typically a matter of weeks. Thus, this method of removing hair for a longer period of time is more suited for use in EKG, EEG and TENS applications as the electrodes may be left in place, if needed, with no concern of immediate hair regrowth and thus no discomfort when removed.

Applicant tested a number of different adhesives. Initially, the adhesives applicant tested were medical grade. However, applicant determined that the medical grade adhesives did not have sufficient strength to remove hair by the root from the follicle. Rather, the medical grade adhesives were all designed to be applied to the skin surface with the least amount of adhesion strength so that when removed, they cause the least discomfort to the patient and does not remove the hair by the root. Applicant determined that the most effective adhesive was one having application in the construction industry. Applicant determined that the acrylate based adhesive ST 1381 has high tack, medium to high peel adhesion, and high cohesive strength, and is non toxic. It has the ability to wet out quickly, or spread quickly between the hair shafts, and is aided by applying pressure for this particular application. This adhesive is approximately 4 times the strength of the average medical grade adhesive. The adhesive of the embodiments herein is similar to an adhesive used in a window and door sealing tape made by 3M Company. The tape is sold under the part number 8777. However the adhesive thickness used in the 3M tape is approximately 2 mils.

Substrate

Applicant determined that the substrate material needed to have limited flexibility to be effective at hair removal. A substrate with too much flexibility or elongation, when the substrate/adhesive assembly was pulled off of the skin, would elongate rather than be removed from the skin. A substrate with too little flexibility was found to be ineffective at holding adhesive on its surface and ineffective when applied to the skin surface at removing hair from the follicle. Applicant determined that the substrate along with the label material and a polymer coating (which will be discussed in more detail below) in combination with the adhesive thickness provided sufficient thickness to the assembly to work well. In particular, when the assembly is being applied to the victim's chest, the thickness and stiffness of the substrate prevent the assembly from folding over on itself and thereby preventing the adhesive from sticking to itself. In addition, the assembly when pulled away from the victim's chest contacts the hair along its length at the point of separation from the skin surface. This contact enables the adhesive to pull the hair by the follicle and remove it completely from the skin. The thickness and stiffness of the assembly also contributes to the pad's ability to distribute the pressure when the pad is applied to the skin. This further ensures that the adhesive contacts as many hairs as possible. In addition, the stiffness and thickness evenly distribute the pull force upon removal.

To achieve the desired thickness of adhesive as discussed above, applicant determined that a substrate with a predetermined contour and porosity was needed. This contour and porosity increased the surface area of the substrate which enabled more adhesive to cling to the substrate, and thus increase the overall thickness of the adhesive layer. In addition, the substrate contour enabled the adhesive to cling to a number of different locations on the substrate which helped the substrate to effectively grip the adhesive layer and prevent the adhesive from pulling away from the substrate when the substrate/adhesive assembly was being pulled away from the skin. The desired depth and contour of the substrate may take the form of pattern divots or recesses in the substrate, wrinkles in the substrate or any manner of formation that enables the adhesive to be stored at a sufficient thickness so that when the substrate is applied to the skin with a moderate level of pressure, hair will be removed at the root from the follicle. When the hair is removed at the root from the follicle, it creates a low impedance pathway thereby further decreasing the impedance across the skin barrier and enabling electrical energy to flow more efficiently.

Applicant determined that a nonwoven substrate of having a thickness of about .00588 inches +/- 10%, and having a repeat pattern of divots was effective, and thus preferable. The preferred material for the substrate is a polyolefin coated spunbond polypropylene having 182 divots per square inch. The divot pattern creates a honeycomb-like pattern and increases the surface area of the substrate. This enables the substrate to hold the adhesive layer more effectively. As the adhesive layer increased in thickness, it leaked through the substrate layer. As such, applicant applied a polymer layer to the surface of the substrate opposite from the surface receiving adhesive. The polymer layer prevents the adhesive from leaking out.

Another aspect of the substrate was its strength or tear resistance. The substrate needed to have sufficient strength to withstand the pull force during use without tearing. Applicant determined that a nonwoven material having a thickness of .00588 inches +/- 10%, and having a repeat pattern of divots would perform as needed without tearing.

It should be appreciated that while the devices, systems, and methods described herein are described in connection with a defibrillation devices and AED devices, the devices, systems, kits and methods of the present embodiments also apply to all external defibrillator systems and monitors including those in hospitals and medical centers. It is also anticipated that the skin preparation devices, methods, systems and kits described herein are equally applicable for use in preparing the skin for any electrode pads applied to the skin surface, including but not limited to EKG, EEG, electromyography or TENS electrodes.

The effectiveness of the transfer of electrical energy across the skin barrier may also make the embodiments herein applicable for transcutaneous energy transfer systems. These systems recharge implanted batteries, such as those in a pacemaker or glucose pump. The use of the skin preparation device described herein would render the transfer of energy across the skin barrier more efficient and require less time.

It is further anticipated that the devices, systems, kits and methods of the embodiments described herein may be applicable to hair removal for both cosmetic and medical reasons for any mammal with hair or fur. For example, one embodiment may be used to prepare the skin for a surgical incision. When hair is shaved or otherwise removed at the skin surface, the hair shaft has a large area. When it is cut, the edge is sharp and abrupt. As it grows, the new growth above the skin surface exposes the cut edge and results in a plurality of short hair lengths having sharp ends. This is commonly known as razor stubble. Regrowth of cut hair holds bacteria and makes an incision site more difficult to keep clean. Hair regrowth from the follicle will require a substantially longer period of time before it is seen on the skin surface, at least a matter of weeks. Hair that regrows after the prior hair is removed at the root from the follicle has a conical tip because it is growing anew. The conical tip is softer to the touch because the tip is pliant and tapered. As a result, as the incision heals, the softer hair growing in around the incision causes less discomfort to the patient. Moreover, by the time the hair regrows, the incision has had time to heal without hair growing around and through it. This method of removing hair for a longer period of time is applicable to incision site preparation in general surgery, and also suited for use in potentially long term electrode applications such as EKG, EEG and TENS applications. In these applications, the electrodes may be left in place, if needed, with no concern of immediate hair regrowth and thus no discomfort when removed. A further advantage of using the device of the embodiments described herein for hair removal prior to surgery is that there are some areas of the body that are difficult to shave. Joints such as knees, shoulders, elbows and the like are difficult to shave effectively because they are not made up of large flat areas. Hair growth in these areas is located in crevices and on contoured surfaces, and ensuring removal of all hair in preparation for an incision is difficult. Shaving in these areas may result in cuts which cause bleeding and introduce infection to the area. Thus, using a device that will quickly and efficiently remove hair at the follicle is desirable.

It is anticipated that the embodiments described herein may have particular application to skin preparation for first aid procedures or battlefield procedures. The embodiments may have application in other disaster and emergency situations and in places where debris and general uncleanliness can impede adequate emergency care.

It is further appreciated that the devices, systems, kits and methods described herein would also be applicable to prepare skin for use with the transfer of electrical energy across and through the skin barrier for drug delivery including but not limited to iontophoretic and transdermal delivery systems. Iontophoretic and transdermal delivery may be enhanced and made further efficient by properly preparing the skin prior to delivery. When the skin is effectively prepared, the delivery mechanism becomes more effective.

Moreover, it is appreciated that while the embodiments described herein have been directed to the hair removal and skin preparation for the use of an AED device and system on humans, it is anticipated that the present embodiments would be equally effective on other mammals such as dogs, cats, horses and the like as needed for hair removal and skin preparation. Mammalian hair or fur in some cases may be more difficult and challenging to remove than human hair. In addition, it is equally important to remove hair and fur at the incision site to keep bacteria and thus infection away. The ability to quickly and effectively remove hair at the follicle is an advantage in this application.

Adhesive Testing As discussed above, applicant found that the preferred adhesive is an acrylate based adhesive. However, applicant tested a number of adhesives to determine the most effective composition. The tests determined which was the most effective for application and removal, as well as skin compatibility. Summary results of these tests are set forth below.

Applicant tested approximately 20 commercially available pressure sensitive adhesives available in tape form applied to at least one surface of a substrate. Each tape was tested initially for feel to determine whether it was sticky enough to pull out hair. Those that passed the initial test, were then applied to a patch of human skin having hair thereon. The tape was applied to the area and a moderate level of pressure was applied to the top surface of the tape to further encourage adhesion between the tape and the skin and hair interfaces. The tape was then pulled quickly away from the skin patch. Efficacy of the tape was made visually by looking at the amount of hair removed. The adhesive selected in the embodiments described herein was the only adhesive tested that was able to remove hair follicles from the root. Data resulting from the tests described above are provided in Table A.

TABLE A

Adhesive Tape Performance Testing Undertaken From November 2012 To May 2013

Bio Compatibility testing was done on 12 different men ranging in age from 27 to 58. The racial makeup of the men were one African American and 11 Caucasians. No adverse effects were observed immediately afterward or recorded 48 hours after use of the first embodiment described herein. The adhesive used in the testing was the same as that described in detail above.

As discussed above, Applicant determined that a thin layer of adhesive was ineffective in effective hair removal and skin preparation. Applicant found that a thin layer of adhesive caused only the uppermost hairs to contact the adhesive and the hairs below to matt. This impeded the adhesive 's ability to make contact with and subsequently remove hairs located closer to the skin surface. Applicant tested a number of different thicknesses of adhesive and determined that a thickness between 8 and 10 mils was most effective at hair removal, and skin preparation, given other parameters such as efficacy and the ability to keep the adhesive on the substrate. A summary of the adhesive thickness testing is provided in Table B.

TABLE B

Adhesive Tape Testing - Hair Removal Effectiveness Undertaken From November 2012 To November 2013

Determinative Criterion: Percentage of hair pulled out from roots

Applicant determined that a nonwoven substrate exhibited superior tear resistance to the polymer sheets. In use, the substrate was able to transfer the adhesive effectively to the skin surface for effective hair removal and skin preparation without the substrate tearing

As discussed above, applicant found that an effective nonwoven substrate could not exhibit extensive elasticity. In some tests, Applicant found that a polymer substrate would stretch or elongate when being pulled away from the skin. This resulted in an ineffective level of hair and debris removal due to force vectors that spread the pulling force unevenly and produced poor results of hair removal. As a result, Applicant determined that an effective substrate would need to have a limited amount of elasticity and a more evenly distributed pulling force to avoid this problem. Applicant tested an initial substrate made of latex. The result was that the test samples were pulled to twice the original length. Applicant realized that such a level of elasticity was not desired. Applicant subsequently tested a nonwoven substrate material. Applicant found that the nonwoven substrates described herein exhibited no elongation and distributed the pulling force evenly which resulted in effective removal of hair and debris. A summary of the substrate testing is provided in Table C.

TABLE C

Substrate Testing - Compatibility with Adhesive Undertaken From November 2012 To November 2013 Determinative Criteria: Capable of being combined with adhesive, acceptable conformity with no elongation, manufacturing compatibility

Impedance Testing To test for efficacy of electrical energy transfer, Applicant tested the impedance across the skin barrier when an alternating electric current was applied. The tests were conducted as follows. Four sites on a subject were chose for testing. These include right and left chest area and the right and left side area. These sites were chosen because these are where an AED electrode would be applied, specifically the right chest and the left side.

Each site on a volunteer subject was marked using a pad template. In the center of the template is a 3 inch x 3 inch square that was marked on the body of the subject. Marked sites have corresponding numbers and letters to identify each site. A Checktrode model 1089 mk 111 using GS27 Disposable Pregelled Electrodes brand impedance meter was used in the testing. The impedance meter was calibrated per the Instruction Manual before each test. A test electrode was placed within the marked square before any hair or debris had been removed and prior to any skin abrasion. The impedance meter was activated and the measurement recorded within 20 seconds. Each test area was then treated with a skin preparation device as described above in the first embodiment 10. In particular the device had an acrylate adhesive having a thickness of about 8 mil. The adhesive was applied to a non woven substrate. The nonwoven substrate was a bleached, calendered kraft stock .00588 inches thick +/- 10%. A semi gloss supercalendered, lightweight, coated face stock .00268 inches thick +/- 10% was adhered to the non woven substrate using a rubber based adhesive for ultimate bond strength. A polypropylene laminate having a thickness of 1.05 mil was applied to the face stock with an adhesive.

After each test site was treated by the skin preparation device to remove hair and debris and abrade the skin, the impedance electrode was placed within the prescribed test area within 15 seconds of hair removal. A second impedance reading was taken at each site.

Photos were taken by one person to record each step of the testing. Photos were used to count hair removal. The photos were used to determine efficacy of the device's ability to remove hair.

Grouped Data and Analysis

A summary chart is provided below showing a summarized version of the data obtained in the impedance tests described above. M m Decrease in fnipeefsn:ce

These tests indicate that the impedance drops after the skin preparation device made in accordance to the embodiments described herein, has been applied to the skin and removed. Even though numerous characteristics and advantages of the embodiments and methods described in the foregoing description and figures, these descriptions are illustrative only. Changes may be made in detail, especially in matters of size, shape, and orientation of parts within the principles of the invention to the full extent indicated by the broad general meaning of the terms in which the appended claims are attached. Furthermore, the terms "upper" and "lower", "top" and "bottom" and the like are used for purposes of illustration and are not designed to limit the scope of the embodiments described herein. Since numerous modifications and changes would occur to those skilled in the art, it is not desired to limit the scope of the embodiments described herein. Accordingly all suitable modifications and equivalents may be resorted to, falling within the scope of the subject embodiments.

Claims

CLAIMS 1. A skin treatment device comprising:

a substrate having a first surface and a second surface;

an adhesive layer covering a portion of the first surface of the substrate, whereby when the adhesive layer is applied to the skin surface of a hair bearing mammal and removed, hair is removed from the follicle.

2. The skin treatment device of claim 1 wherein the adhesive layer is of a sufficient thickness so as to effectively encapsulate the hair strand.

3. The device of claim 1 wherein the adhesive layer is at least about 4 mils thick.

4. The device of claim 1 wherein after the adhesive layer is applied to the skin surface of the mammal and removed, the application site exhibits decreased impedance.

5. The device of claim 4 wherein the impedance decrease is above about 35%.

6. The device of claim 1 wherein the hair is removed at the root.

7. A method of treating skin, comprising the steps of:

providing a substantially flat substrate having a first surface and a second surface;

providing an adhesive layer on at least a portion of the first surface of the substrate, placing the first surface of the substrate against the skin of a hair bearing mammal thereby causing the adhesive layer to contact the skin;

removing the substrate from contact with the skin surface of the mammal, thereby causing the adhesive to pull the hair from the follicle.

8. The method of claim 7 wherein the adhesive layer is of a sufficient thickness so as to effectively encapsulate the hair strand.

9. The method of claim 7 wherein the adhesive layer is at least about 4 mils thick.

10. The method of claim 7 wherein the impedance across the skin at the application site is decreased.

11. The method of claim 10 wherein the impedance is decreased by at least more than 35%.

12. The method of claim 7 wherein the hair is removed at the root.

13. A skin preparation device for use with a defibrillator comprising: a substrate having a first surface and a second surface; and

an adhesive layer covering at least a portion of the first surface of the substrate, whereby when the adhesive layer is applied to the skin surface of a hair bearing mammal and removed, hair is removed from the follicle.

14. The skin preparation device of claim 13 wherein the adhesive layer is of a sufficient thickness so as to effectively encapsulate the hair strand.

15. The device of claim 13 wherein the adhesive layer is at least about 4 mils thick.

16. The device of claim 13 wherein after the adhesive layer is applied to the skin surface of the hair bearing mammal and removed, the application site exhibits decreased impedance.

17. The skin preparation device of claim 16 wherein when the device is applied to the skin and removed, the impedance level at the application site decreases by more than about 35%.

18. The skin preparation device of claim 13 wherein when the device is applied to the chest area of an adult male having chest hair, the impedance level at the application site decreases by at least 35 % .

19. The device of claim 13 wherein the hair is removed at the root.

20. A defibrillator system comprising:

a power unit for delivering electrical energy across the skin surface;

a pair of electrodes in electrical communication with the power unit;

an activation switch; and

a pair of skin preparation pads, each pad comprising

a substrate having a first surface and a second surface,

an adhesive layer covering at least a portion of the first surface of the substrate, whereby when the adhesive layer of the pad is applied to the skin surface of a hair bearing mammal and removed, hair is removed from the follicle.

21. The system of claim 20 wherein the adhesive layer is of a sufficient thickness so as to effectively encapsulate the hair strand.

22. The system of claim 20 wherein the adhesive layer is at least about 4 mils thick.

23. The system of claim 20 wherein after the adhesive layer is applied to the skin surface of the mammal and removed, the application site exhibits decreased impedance.

24. The system of claim 23 wherein when the skin preparation device is applied to the skin and removed, the impedance level decreases by at least more than 35%.

25. The system of claim 24 wherein when the skin preparation device is applied to an adult male subject with chest hair in the chest area, the impedance level at the application site decreases by at least more than about 35%.

26. The system of claim 20 wherein when the hair is removed from the follicle, the hair is removed at the root.

27. A device for removing hair from the follicle, the device comprising:

a substrate having a first surface and a second surface;

an adhesive layer covering at least a portion of the first surface of the substrate, the adhesive layer being of sufficient thickness so as to encapsulate the hair strand, whereby when the adhesive layer is applied to the skin surface of a hair bearing mammal and removed, the hair root is removed from the follicle.

28. The device of claim 27 wherein the adhesive is of a sufficient thickness so as to effectively encapsulate the hair strand.

29. The device of claim 27 wherein the adhesive is at least 4 mils thick

30. The device of claim 27 wherein after the adhesive layer is applied to the skin surface of the mammal and removed, the application site exhibits decreased impedance.

31. The device of claim 27 wherein the impedance decrease is at least more than about 35%.

32. The device of claim 27 wherein the hair is removed at the root.

33. A skin preparation device for use in delivering drug across the skin barrier comprising:

a substrate having a first surface and a second surface;

34. The device of claim 33 wherein the adhesive layer is of a sufficient thickness so as to encapsulate the hair strand,

35. The device of claim 33 wherein the adhesive is at least 4 mils thick.

36. The device of claim 33 wherein after the adhesive layer is applied to the skin surface of the mammal and removed, the application site exhibits decreased impedance.

37. The device of claim 36 wherein the impedance decrease is at least more than about 35%.

38. The device of claim 33 wherein the hair is removed at the root.

39. The device of claim 33 wherein the drug is delivered transdermally or

iontophoretically.

40. A method of delivering drug across the skin of a hair bearing mammal comprising: selecting a skin preparation site;

applying a skin preparation device to the skin surface at the skin preparation site, the skin preparation device comprising

a substrate having a first surface and a second surface, and

an adhesive layer covering at least portion of the first surface of the substrate;

removing the skin preparation device from the skin at the skin preparation site; and applying a drug delivery device to the skin preparation site.

41. The method of claim 40 wherein, the adhesive layer is of sufficient thickness so as to encapsulate the hair strand.

42. The method of claim 40 wherein the adhesive layer is at least 4 mils thick.

43. The method of claim 40 wherein after the adhesive layer is applied to the skin surface of the mammal and removed, the application site exhibits decreased impedance.

44. The method of claim 43 wherein the impedance decrease is at least about 35%.

45. The method of claim 40 wherein the hair is removed at the root.

46. A drug delivery kit for a hair bearing mammal comprising:

a skin preparation device comprising a substrate having a first surface and a second surface, and

an adhesive layer covering at least a portion of the first surface of the substrate; and a drug delivery device.

47. The drug delivery kit of claim 46 wherein the adhesive layer is of sufficient thickness so as to encapsulate the hair strand.

48. The drug delivery kit of claim 46 wherein the thickness of the adhesive layer is at least about 4 mils.

49. The drug delivery kit of claim 46 wherein after the adhesive layer is applied to the skin surface of the mammal and removed, the application site exhibits decreased impedance.

50. The drug delivery kit of claim 49 wherein the impedance decrease is at least more than about 35%.

51. The drug delivery kit of claim 46 wherein the hair is removed at the root.

52. The drug delivery kit of claim 46 wherein the drug delivery device delivers drug transdermally or iontophoretically.

53. A device for decreasing impedance across the skin comprising:

a substrate having a first surface and a second surface;

an adhesive layer covering at least a portion of the first surface of the substrate, whereby when the adhesive layer is applied to the skin surface of a hair bearing mammal and removed, impedance across the skin is decreased.

54. The device of claim 53 wherein the adhesive layer is of sufficient thickness to encapsulate the hair strand.

55. The device of claim 53 wherein the adhesive layer is at least 4 mils thick.

56. The device of claim 53 wherein the impedance is decreased by more than about 35%.

57. The device of claim 56 wherein when the device is applied to an adult male subject with chest hair in the chest area, the impedance level at the application site decreases by more than about 35%.

58. The device of claim 53 wherein the hair is removed at the root.

59. A method for decreasing impedance across the skin barrier of a hair bearing mammal comprising:

providing a substrate having a first surface and a second surface, and an adhesive layer;

applying the substrate to the skin surface of a mammal;

removing the substrate from the skin surface, whereby impedance across the skin is decreased.

60. The method of claim 59 wherein the adhesive layer is of sufficient thickness to encapsulate the hair strand.

61. The method of claim 59 wherein the adhesive has a thickness of about at least 4 mils.

62. The method of claim 59 wherein the impedance is decreased by at least more than 35%.

63. The method of claim 59 wherein when the substrate is removed from the skin surface, hair is removed at the root.