Note: Descriptions are shown in the official language in which they were submitted.
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1 DEVICE, SYSTEM, METHOD AND KIT FOR PREPARING SKIN
2 Field
3 The embodiments described herein focus on a device, system, method and
kit for removing hair
4 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
6 contact with an electrode, as well as delivering drugs transdermally or
iontophoretically. The
7 embodiments enhance the efficiency of the transfer of electrical energy
across the skin barrier
8 making defibrillation or drug delivery more effective while using less
power.
9 Background of the Invention
The skin barrier provides mammals with protection from harmful bacteria, the
elements and the
11 like. However, penetrating the skin barrier, at times, may be
beneficial, even life saving. The
12 application of electric current to reestablish normal heart rhythm and
drug delivery by
13 transdermal and iontophoretic means are examples of the benefits of
penetrating the skin barrier
14 in mammals.
Defibrillation is a common treatment given to one who is experiencing cardiac
dysrhythmia,
16 ventricular fibrillation or pulseless ventricular tachycardia which is
referred to generally as
17 "sudden cardiac arrest". The external defibrillation procedure involves
applying electrodes in
18 the form of a pair paddles or electrode pads to the skin in the chest
area of a patient experiencing
19 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
21 patient's body to "restart" or return the heart to normal sinus rhythm.
It should be noted that the
22 term electrode, unless otherwise indicated, includes electrode pads.
23 There are four types of defibrillators. ALS (Advanced Life Safety)
machines which are used by
24 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
26 defibrillators. Our invention primarily pertains to the ALS and AED
defibrillators and wearable.
27 AED stations include a power source, pairs of electrodes and a set of
instructions and other
28 accessories that may be used by the person delivering the treatment. AED
stations are
29 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
31 need until emergency response personnel arrive. Electrode pads are
intended to be placed on the
32 victim's bare chest and the AED unit analyzes the hearts rhythm to
determine whether an electric
33 shock should be delivered and the quantity of electrical current to be
used
1
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1 When delivering electrical energy across the skin, whether for
defibrillation or drug delivery, the
2 skin itself it the greatest barrier. Hair, dead skin cells and debris on
the skin surface contribute to
3 impedance. Impedance is the total opposition to alternating current in a
circuit. When delivering
4 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
6 effectively deliver the appropriate level of current across the skin
barrier, the skin's surface
7 should free of anything that can interfere with the defibrillator's
performance. Impedance, in
8 the form of hair, debris and skin lessen electrode pad to skin contact
and can adversely affect
9 defibrillation results.
The primary electrical impedance is the skin itself. It creates what is known
as "physiologic
11 artifact". Artifact is a noise and impedance that is noticed as an
imperfect reading, such as with
12 an EKG system, or with an AED system. This occurs, in part, because the
epidermis refuses
13 electrical current due to its dead skin cells lying on the surface. Skin
has its own resistance
14 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
16 optimizes the analysis and in the case of AEDs, enables a higher quality
of diagnosis and
17 electrical current to pass across the skin barrier.
18 The emergency kits by necessity need to be easy to understand and
operate because they may be
19 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
21 may require the user to attempt to shave the chest hair quickly prior to
the application of the
22 electrode pads to the skin. This can often cause cutting of the skin
because the razor is applied
23 quickly to dry skin, and it may not be completely effective. If there is
an incomplete contact
24 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
26 operated by those not familiar with the equipment, and thus the user may
be in a stressed state of
27 mind. Those who try to provide help may not appreciate the importance of
skin to electrode
28 contact and may fail to adequately prepare the skin. Some patients have
experienced burning on
29 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
31 inability of the electrical energy to move across the skin barrier as a
result of poor skin contact
32 with the electrode pads.
33 It is worth noting that there is a balance between an effective system
and method of preparing the
34 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,
36 contact between the skin and electrode pad will be less effective and
the efficacy of defibrillation
37 will be compromised.
2
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1 Numerous adhesive backed substrates have been developed for wound care
and the like. These
2 however focus on the ability to effectively adhere to the skin surface
surrounding the wound
3 without removing hair and causing the least discomfort or disturbance
upon removal.
4 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
6 for the use of an automated external defibrillator. The second reference
is US Publication
7 2012/0029530 to Gunstream et al.
8 There is a need for a device, system, method and kits that includes a
sufficient level of adhesive
9 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
11 further need for a device, system, method and kit that substantially
decreases the impedance level
12 across the skin at the application site. These and other attributes of
the preferred embodiments
13 without the disadvantages of the aforementioned disclosures will be
described in detail below.
14 Brief Description of Drawings
Fig. 1 shows a plan view of the first embodiment described herein.
16 Fig. 2 shows a sectional view of the embodiment of Fig. 1.
17 Fig. 3 shows an enlarged side view of the embodiment of Fig. 1 in use.
18 Fig. 4 is a diagrammatic representation of the second embodiment
described herein.
19 Fig. 5A is a side view of the third embodiment described herein.
Fig. 5B is a top view of the third embodiment of Fig. 5A.
21 Fig. 6 is a perspective view of the third embodiment of Fig. 5A in use.
22 Detailed Description
23 First Embodiment
24 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
26 liner 14 has a first liner surface 16 and a second liner surface 18, as
shown in Fig. 2. Pads 12, 20
27 are disposed on the first liner surface 16.
28 The second pad 20 is identical in construction to the first pad 12. The
liner 14 is divisible in that
29 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
3
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1 the divisible liner in an AED system for use to remove hair, debris from
the skin and effectively
2 abrade the skin so as to properly prepare the skin to receive the AED
electrodes.
3 Pads 12, 20 are identical and thus will be described collectively. Each
pad 12, 20 has an upper
4 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
6 laminate. The laminate layer 28 provides water resistance and prevents
the adhesive layer from
7 leaking out the opposite side of the substrate 32. The top layer 28
protects the label 30 which is
8 located adjacent to the top layer. The label 30 is applied to a substrate
32 with adhesive. The
9 label 30 has been designed to provide diagrammatic and written
instruction to the user as to how
to use the pads12, 20 to prepare the skin.
11 A layer of adhesive 34 is applied to a portion of the substrate 32 along
the lower pad surface 26.
12 Preferably, the adhesive 34 is an acrylate adhesive having a thickness
of between about 4 andl 0
13 mils. Preferably, the adhesive thickness must be at least about 8 mils.
Preferably the substrate
14 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
16 point of the substrate. Further features and characteristics of the
substrate will be discussed in
17 more detail below.
18 A portion of the substrate 32 does not have adhesive 34 thereon and
serves as a grip 36 during
19 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
21 surface 16 of the liner is adjacent to the adhesive 34. The liner 14
preserves the adhesive 34
22 prior to use. The liner 14 is folded so that the pads are stacked on top
of each other with the liner
23 there between. In addition, the pads, 12, 20 and liner 14 may be
hermetically sealed within a
24 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
26 anticipated that the sealed bag containing the pads would be packaged in
a manner that makes
27 opening easy and quick. This may be accomplished by using a horizontal
seal and a saw tooth
28 cut on the top and bottom of the package. The horizontal seal and saw
tooth cut are designed so
29 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
31 person, or someone who is disabled. The bag 40, with this design has
been tested to be opened,
32 the pads are applied to the skin and removed in less than 15 seconds.
33 The pads 12, 20 are separated at the liner 14 or removed from the liner
without separating the
34 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,
36 it is placed on the skin surface at the location shown on the label. For
example the first pad 12,
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1 may be placed in the patient's upper right chest area. With the liner 14
removed, the adhesive 34
2 is able to effectively contact the skin surface, and all of the hair in
the contact area. It is
3 preferred that the user or operator apply manual pressure to the pad 12
before removing it so as
4 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
6 the skin surface. By fully enveloping each hair shaft, the adhesive is
able to effectively grip the
7 hair and maintain its hold during removal which is discussed in detail
below.
8 After pressure is applied, the user grasps one of the grips 36 and pulls
quickly and firmly in a
9 motion away from the skin surface, essentially at a 1800 degree angle
from the adhesive/skin
barrier, as shown in Fig. 3. Arrow A represents the desired direction of the
pull force. The pull
11 force on the pad 12 causes the pad to pull away from the skin surface.
As the pad 12 is removed
12 from the skin surface, the adhesive 34 maintains its grip on the hairs
it has enveloped so as to
13 pull the hairs by their root from the follicle. As can be seen in Fig.
3, the hair shaft above surface
14 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
16 as it is pulled by its root from the follicle.
17 Applicant determined that by enveloping or encapsulating the length of
the hair shaft within the
18 adhesive, the device, when removed from the skin surface, was able to
effectively pull the hair
19 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
21 considerably slows hair regrow at the site. These advantages will be
discussed in more detail
22 below.
23 In addition, to the removal of hair as described above, with the pad 12
removal from the skin
24 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
26 as abrasion.
27 The application and removal of the pad 12 may also causes a histamic
response at the application
28 site. The histamic response is present in the form of acute inflammatory
response. The body
29 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
31 removed quickly. Dry skin is a very poor conduit. The histamic response
delivers liquid to the
32 affected skin and further enhances the transfer of electrical energy
across the skin barrier
33 This process is repeated for the second pad 20 which is placed along the
patient's left side as
34 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
5
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1 the skin in an effort to restore the patient's normal heart rhythm. The
locations where the pads
2 12, 20 were applied are referred to as the application sites.
3 Second Embodiment
4 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
6 an AED device 44. The AED device 44 includes a housing 46, a power
source, such as a battery
7 (not shown), an activation switch or button 48, a screen 50, and a pair
of electrode pads 52. The
8 electrode pads 52 are electrically connected to the AED device by cables
54.
9 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
11 locations on the patient's chest and subsequently removes each. After
the skin at both
12 application sites has been prepared, the user places the electrode pads
52 at each preparation site
13 and turns the power to the AED device 44 on. This may be achieved by
turning the switch 48 to
14 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
16 device 44 determines that the heart is in need of treatment, the device
will deliver an amount of
17 electrical energy through the skin and into the chest cavity in an
effort to return the heart to its
18 normal rhythm.
19 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
21 removed at the follicle, and dead skin cells and debris are also
removed. By removing hair at the
22 root from the follicle, the impedance is substantially diminished. This
results in the ability of the
23 AED power source 46 to more accurately deliver the precise amount
electrical energy to the
24 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
26 contact between the skin and electrode pad. In addition, by removing
hair at the root and thus
27 substantially decreasing the impedance, the AED device 44 is also able
to more accurately
28 diagnose the heart behavior and deliver a more effective dose of energy
without the interference
29 of hair, dead skin cells and the like.
Third Embodiment
31 A third embodiment 56 is directed to a hair removal device and is
disclosed in Figs. 5A and 5B
32 and Fig. 6. The third embodiment 56 includes a rectangularly shaped
substrate 58 having first 60
33 and second 62 surfaces. An adhesive layer 64 is applied to a portion of
the first surface 60 of the
34 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
36 protects it prior to use.
6
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1 In use, the removable liner 68 on the third embodiment 56 is removed to
expose the adhesive
2 layer 64. The substrate 58 is placed on the surface of the skin in an
area in which hair is to
3 removed, such as a woman's leg, as shown in Fig. 6. The substrate 58 is
placed so that the
4 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
6 and any air pockets are removed. The user grasps the grip 66 portion of
the substrate 58 and
7 pulls away from the skin surface in a direction 180' degrees from the
adhesive/skin barrier. As
8 the substrate 58 is pulled from the skin surface, the hair shaft
enveloped by the adhesive, is
9 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
11 needed to remove the hair from a leg. For surgical preparation
application, a single substrate 58
12 may be used to prepare the skin for surgery. It is further envisioned
that the substrate 58 in this
13 third embodiment 56 may be shaped differently to accommodate different
cosmetic and medical
14 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
16 the substrate is used for cosmetic applications, it is envisioned that
the substrate may be shaped
17 to accommodate hair removal located in certain places on the body, such
as the eyebrow, upper
18 lip, bikini line, etc.
19 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
21 be used to remove hair, and/or fur, from a mammal such as a dog or cat
prior to undergoing
22 surgery as discussed above for humans. In addition, the third embodiment
56 may be equally
23 applicable for surgical site preparation for mammals since many mammals
have hair and/or fur
24 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
26 holding bacteria, and it is more comfortable for the mammal as the fur
or hair grows in at a
27 slower rate and causes less irritability to the skin. The embodiment 56
may be used on any
28 mammal where hair or fur needs to be removed.
29 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
31 like. Moreover, while applicant refers generally herein to hair and
human skin, applicants notes
32 that term "hair" equally applies to fur, pelage, wool or other soft
coating growing out of the
33 follicle of a mammal.
34 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
36 or iontophoresis.
7
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1 Development Factors
2 Applicant will now address the various factors involved in the
development of the embodiments
3 described herein and the factors in determining the selection of
materials and specifications that
4 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
6 properties in order for the device as a whole to work effectively and
remove hair from the
7 follicle.
8 It was further determined that effective removal of hair at the root from
the follicle, as well as
9 removing dead skin cells and debris, and abrading the skin contributed to
decreasing impedance
across the skin barrier.
11 A study was conducted by J.W. Bissing and R.E. Kerber from the
University of Iowa analyzing
12 the effects of shaving chest hair and impedance. The study, entitled
"Effect of Shaving the Chest
13 of Hirsute Subjects on Transthoracic Impedance to Self Adhesive
Defibrillation Electrode Pads",
14 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
16 males. The initial average impedance was found to be 163 ohms. This is
the same as that found
17 in applicant's studies. The results indicated that by shaving the chest
the impedance decreases
18 by about 35%. As can be seen from the data provided below, applicant was
able to achieve a
19 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
21 of energy through the skin, requires less electricity to enter the
patient's body and less energy
22 drain on the system. In the case of an AED, the need for less energy may
result in a smaller
23 battery, ability to recharge more quickly and the ability to more
accurately diagnose the heart
24 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
26 efficient transfer of electrical energy across the skin barrier.
27 Also, the application and removal of the embodiments may result in a
localized histaminic
28 response. The histaminic response is present in the form of acute
inflammatory response. The
29 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
31 hair being removed quickly. Dry skin is a very poor conduit. The
histaminic response delivers
32 liquid to the affected skin and enhances the transfer of electrical
energy across the skin barrier.
33 Adhesive
34 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
8
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1 hair removal at the follicle. This is due to the fact that mammalian hair
grows in layers. When a
2 thin layer of adhesive is applied to the skin, only the outermost hairs
are able to make contact
3 with the adhesive and thus are the only ones to be removed. In initial
tests conducted by
4 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
6 shaft at the point of contact with the adhesive. The application of a
thin layer of adhesive also
7 left the hairs closer to the skin surface completely intact. And it did
not effectively remove dead
8 skin cells or debris because the adhesive was not able to penetrate
effectively onto the skin
9 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.
11 Applicant further observed that when the adhesive layer was too thick
(greater than about 32
12 mils) it was found that the adhesive would not pull away from the skin
with the substrate. Rather
13 with an excessively thick layer of adhesive, the adhesive would pull
apart from itself and leave
14 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
16 ooze from the sizes of the assembly and not remain below the lower
surface of the substrate.
17 In addition, it was determined that when the adhesive layer is of a
certain viscosity, it remains
18 flexible against the substrate yet envelopes and pulls the hairs out of
the skin from the follicle.
19 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
21 remove the hair at the follicle and not at the skin surface. Therefore
the adhesive must be soft
22 enough and be able to flow to achieve optimum skin adhesion and hair
shaft envelopment.
23 In addition, when hair is removed at the root from the follicle, the
regrowth of that hair will
24 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
26 matter of hours. Hair regrowth at the follicle will require a
substantially longer period of time
27 before it is seen on the skin surface, typically a matter of weeks.
Thus, this method of removing
28 hair for a longer period of time is more suited for use in EKG, EEG and
TENS applications as
29 the electrodes may be left in place, if needed, with no concern of
immediate hair regrowth and
thus no discomfort when removed.
31 Applicant tested a number of different adhesives. Initially, the
adhesives applicant tested were
32 medical grade. However, applicant determined that the medical grade
adhesives did not have
33 sufficient strength to remove hair by the root from the follicle.
Rather, the medical grade
34 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
36 remove the hair by the root.
9
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1 Applicant determined that the most effective adhesive was one having
application in the
2 construction industry. Applicant determined that the acrylate based
adhesive ST 1381 has high
3 tack, medium to high peel adhesion, and high cohesive strength, and is
non toxic. It has the
4 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
6 average medical grade adhesive. The adhesive of the embodiments herein is
similar to an
7 adhesive used in a window and door sealing tape made by 3M Company. The
tape is sold under
8 the part number 8777. However the adhesive thickness used in the 3M tape
is approximately 2
9 mils.
11 Substrate
12 Applicant determined that the substrate material needed to have limited
flexibility to be effective
13 at hair removal. A substrate with too much flexibility or elongation,
when the substrate/adhesive
14 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
16 and ineffective when applied to the skin surface at removing hair from
the follicle. Applicant
17 determined that the substrate along with the label material and a
polymer coating (which will be
18 discussed in more detail below) in combination with the adhesive
thickness provided sufficient
19 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
21 on itself and thereby preventing the adhesive from sticking to itself.
In addition, the assembly
22 when pulled away from the victim's chest contacts the hair along its
length at the point of
23 separation from the skin surface. This contact enables the adhesive to
pull the hair by the follicle
24 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
26 further ensures that the adhesive contacts as many hairs as possible. In
addition, the stiffness and
27 thickness evenly distribute the pull force upon removal.
28 To achieve the desired thickness of adhesive as discussed above,
applicant determined that a
29 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,
31 and thus increase the overall thickness of the adhesive layer. In
addition, the substrate contour
32 enabled the adhesive to cling to a number of different locations on the
substrate which helped the
33 substrate to effectively grip the adhesive layer and prevent the
adhesive from pulling away from
34 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
36 substrate, wrinkles in the substrate or any manner of formation that
enables the adhesive to be
37 stored at a sufficient thickness so that when the substrate is applied
to the skin with a moderate
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1 level of pressure, hair will be removed at the root from the follicle.
When the hair is removed at
2 the root from the follicle, it creates a low impedance pathway thereby
further decreasing the
3 impedance across the skin barrier and enabling electrical energy to flow
more efficiently.
4 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
6 material for the substrate is a polyolefin coated spunbond polypropylene
having 182 divots per
7 square inch. The divot pattern creates a honeycomb-like pattern and
increases the surface area of
8 the substrate. This enables the substrate to hold the adhesive layer more
effectively. As the
9 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
11 adhesive. The polymer layer prevents the adhesive from leaking out.
12 Another aspect of the substrate was its strength or tear resistance. The
substrate needed to have
13 sufficient strength to withstand the pull force during use without
tearing. Applicant determined
14 that a nonwoven material having a thickness of .00588 inches +/- 10%,
and having a repeat
pattern of divots would perform as needed without tearing.
16 It should be appreciated that while the devices, systems, and methods
described herein are
17 described in connection with a defibrillation devices and AED devices,
the devices, systems,
18 kits and methods of the present embodiments also apply to all external
defibrillator systems and
19 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
21 preparing the skin for any electrode pads applied to the skin surface,
including but not limited to
22 EKG, EEG, electromyography or TENS electrodes.
23 The effectiveness of the transfer of electrical energy across the skin
barrier may also make the
24 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
26 preparation device described herein would render the transfer of energy
across the skin barrier
27 more efficient and require less time.
28 It is further anticipated that the devices, systems, kits and methods of
the embodiments described
29 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
31 incision. When hair is shaved or otherwise removed at the skin surface,
the hair shaft has a large
32 area. When it is cut, the edge is sharp and abrupt. As it grows, the new
growth above the skin
33 surface exposes the cut edge and results in a plurality of short hair
lengths having sharp ends.
34 This is commonly known as razor stubble. Regrowth of cut hair holds
bacteria and makes an
incision site more difficult to keep clean.
11
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1 Hair regrowth from the follicle will require a substantially longer
period of time before it is seen
2 on the skin surface, at least a matter of weeks. Hair that regrows after
the prior hair is removed
3 at the root from the follicle has a conical tip because it is growing
anew. The conical tip is softer
4 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
6 hair regrows, the incision has had time to heal without hair growing
around and through it. This
7 method of removing hair for a longer period of time is applicable to
incision site preparation in
8 general surgery, and also suited for use in potentially long term
electrode applications such as
9 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.
11 A further advantage of using the device of the embodiments described
herein for hair removal
12 prior to surgery is that there are some areas of the body that are
difficult to shave. Joints such as
13 knees, shoulders, elbows and the like are difficult to shave effectively
because they are not made
14 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
16 these areas may result in cuts which cause bleeding and introduce
infection to the area. Thus,
17 using a device that will quickly and efficiently remove hair at the
follicle is desirable.
18 It is anticipated that the embodiments described herein may have
particular application to skin
19 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
21 uncleanliness can impede adequate emergency care.
22 It is further appreciated that the devices, systems, kits and methods
described herein would also
23 be applicable to prepare skin for use with the transfer of electrical
energy across and through the
24 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
26 properly preparing the skin prior to delivery. When the skin is
effectively prepared, the delivery
27 mechanism becomes more effective.
28 Moreover, it is appreciated that while the embodiments described herein
have been directed to
29 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
31 dogs, cats, horses and the like as needed for hair removal and skin
preparation. Mammalian hair
32 or fur in some cases may be more difficult and challenging to remove
than human hair. In
33 addition, it is equally important to remove hair and fur at the incision
site to keep bacteria and
34 thus infection away. The ability to quickly and effectively remove hair
at the follicle is an
advantage in this application.
36 Adhesive Testing
12
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1 As discussed above, applicant found that the preferred adhesive is an
acrylate based adhesive.
2 However, applicant tested a number of adhesives to determine the most
effective composition.
3 The tests determined which was the most effective for application and
removal, as well as skin
4 compatibility. Summary results of these tests are set forth below.
Applicant tested approximately 20 commercially available pressure sensitive
adhesives available
6 in tape form applied to at least one surface of a substrate. Each tape
was tested initially for feel
7 to determine whether it was sticky enough to pull out hair. Those that
passed the initial test,
8 were then applied to a patch of human skin having hair thereon. The tape
was applied to the area
9 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
11 away from the skin patch. Efficacy of the tape was made visually by
looking at the amount of
12 hair removed. The adhesive selected in the embodiments described herein
was the only adhesive
13 tested that was able to remove hair follicles from the root. Data
resulting from the tests described
14 above are provided in Table A.
13
TABLE A
Adhesive Tape Performance Testing Undertaken From November 2012 To May 2013
0
w
o
Broken or or Hair removed Limited hair Good hair Uneven
distribution Damage to Residue left o
'a
damaged hair? from the follicle? removal? removal? of hair
removal? skin? on skin? 1¨
.6.
vi
o
oe
Medical tapes (8)
MO1 YES NO YES NO YES
NO NO
M02 YES NO YES NO YES
NO NO
M03 YES NO NO YES YES
NO YES
M04 YES NO YES NO YES
NO NO
M05 YES NO NO YES NO
NO YES
M06 NO NO YES NO NO
NO YES P
M07 NO NO YES NO YES
NO NO
r.,
u,
M08 YES NO YES NO YES
NO NO u,
Commercial tapes (10)
0
r.,
0
,
,
,
CO1 YES NO YES NO YES
NO YES
,
,
r.,
CO2 YES NO NO YES NO
NO YES 0
CO3 NO NO NO YES YES
YES NO
C04 NO NO YES NO NO
YES YES
C05 YES NO YES NO NO
YES YES
C06 NO NO NO YES YES
NO NO
C07 YES NO YES NO YES
YES NO
C08 YES NO NO YES NO
NO YES
1-d
C09 NO NO NO YES YES
NO YES n
,-i
C10 NO NO YES NO YES
YES NO
cp
Industrial tapes (2)
w
o
1¨
vi
101 YES NO NO YES YES
YES YES 'a
.6.
1-
102 NO YES NO YES NO
NO NO c,.)
o
w
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1 Bio Compatibility testing was done on 12 different men ranging in age
from 27 to 58. The
2 racial makeup of the men were one African American and 11 Caucasians. No
adverse effects
3 were observed immediately afterward or recorded 48 hours after use of the
first embodiment
4 described herein. The adhesive used in the testing was the same as that
described in detail
above.
6 As discussed above, Applicant determined that a thin layer of adhesive
was ineffective in
7 effective hair removal and skin preparation. Applicant found that a thin
layer of adhesive
8 caused only the uppermost hairs to contact the adhesive and the hairs
below to matt. This
9 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
11 determined that a thickness between 8 and 10 mils was most effective at
hair removal, and
12 skin preparation, given other parameters such as efficacy and the
ability to keep the adhesive
13 on the substrate. A summary of the adhesive thickness testing is
provided in Table B.
14
TABLE B
16 Adhesive Tape Testing ¨
17 Hair Removal Effectiveness Undertaken From November 2012 To November
2013
18
19 Determinative Criterion: Percentage of hair pulled out
from roots
Percentage hair Testing Comments
removed from timeframe
follicle
Adhesive
thickness (ml)
2 <25% November 2012
5 25%-50% July 2013
6 51%-75% August 2013
8 >75% October 2013
10 >75% October 2013 Issues relating to
adhesive
oozing and spreading;
8 >75% November 2013 Tested with revised
substrate having greater
surface area to hold
adhesive layer.
21
22 Applicant determined that a nonwoven substrate exhibited superior tear
resistance to the
23 polymer sheets. In use, the substrate was able to transfer the adhesive
effectively to the skin
24 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
26 extensive elasticity. In some tests, Applicant found that a polymer
substrate would stretch or
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1 elongate when being pulled away from the skin. This resulted in an
ineffective level of hair
2 and debris removal due to force vectors that spread the pulling force
unevenly and produced
3 poor results of hair removal. As a result, Applicant determined that an
effective substrate
4 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
6 the test samples were pulled to twice the original length. Applicant
realized that such a level
7 of elasticity was not desired. Applicant subsequently tested a nonwoven
substrate material.
8 Applicant found that the nonwoven substrates described herein exhibited
no elongation and
9 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.
11
12 TABLE C
13 Substrate Testing ¨
14 Compatibility with Adhesive Undertaken From November 2012 To November
2013
16 Determinative Criteria: Capable of being combined with adhesive,
acceptable conformity with no
17 elongation, manufacturing compatibility
Substrate Type Testing timeframe Conclusion
Waterproof November 2012 ¨ Too flexible. Could be cut reliably
but could not
membrane July 2013 hold thickness of adhesive at levels
needed.
Scrim August 2013 Incapable of holding adhesive
thickness levels
needed and could not be reliably cut into
shapes.
Foam August 2013 Incapable of accepting adhesive
thickness levels
needed.
Polyester September 2013 Too rigid. Could not hold adhesive
thickness at
levels needed.
Polyethylene October 2013 Too rigid. Could not hold adhesive
thickness at
levels needed.
Non-woven liner November 2013 Capable of being combined with
adhesive
thickness at levels needed, acceptable
conformity with no elongation, can be reliably
cut.
18
19 Impedance Testing
To test for efficacy of electrical energy transfer, Applicant tested the
impedance across the
21 skin barrier when an alternating electric current was applied. The tests
were conducted as
16
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1 follows. Four sites on a subject were chose for testing. These include
right and left chest
2 area and the right and left side area. These sites were chosen because
these are where an
3 AED electrode would be applied, specifically the right chest and the left
side.
4 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
6 have corresponding numbers and letters to identify each site. A
Checktrode model 1089 mk
7 111 using GS27 Disposable Pregelled Electrodes brand impedance meter was
used in the
8 testing. The impedance meter was calibrated per the Instruction Manual
before each test.
9 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
11 measurement recorded within 20 seconds. Each test area was then treated
with a skin
12 preparation device as described above in the first embodiment 10. In
particular the device
13 had an acrylate adhesive having a thickness of about 8 mil. The adhesive
was applied to a
14 non woven substrate. The nonwoven substrate was a bleached, calendered
kraft stock .00588
inches thick +1- 10%. A semi gloss supercalendered, lightweight, coated face
stock .00268
16 inches thick +1- 10% was adhered to the non woven substrate using a
rubber based adhesive
17 for ultimate bond strength. A polypropylene laminate having a thickness
of 1.05 mil was
18 applied to the face stock with an adhesive.
19 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
21 seconds of hair removal. A second impedance reading was taken at each
site.
22 Photos were taken by one person to record each step of the testing.
Photos were used to
23 count hair removal. The photos were used to determine efficacy of the
device's ability to
24 remove hair.
26
17
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Grouped Data and AnWysis
ff, - ---- = = --------------------------------- ------------------ -: --------
--------+-----------------------f!------------------------------- -------------
----- ----------------- ----------------- -----
subject Chest Sides
::.
1. 131 --. 21 84 $.1{3fiff:
60 ifi'.! 8 . 9Ø.ii,.
:
: ..
2: 180i .2ci 84....9..,..,...',: 56 7 87 .5(5,=0
310,%i .34 62.5% .36 29 19.4 ,?ffo
.................................................... 4. .......
.4 Ill :: 41 63.1% 41 4 li 2.4gff.,
. ............... ..1.. ,
1 16%i 8 '..'f 517.3f.i. 96 713
............................................................... .
2. .1103 ..13f,,:f 66 4% 51
. .
.. .4.
..3 190 ';',;, 8O.9,?..b 38 21
'..------- --------------------------------------------
---------- --------------- ..if. , ,................
4. 172:: -2.4 81.,i,if,3fo 52 3g a')
Mean 163 38 --:-..........iiiiiiiiii-10,2% 513 37
f..............fiffifif.f.f.:3%.5%
........................
Median 176 36:gf.f.::::::::::::::::::g1A% 52 34
STDDEV 38 21 :::::::::::::ii.i.f.ii.::::::46i:144 23
_____________________ f::: fiii:i:iiiiiiiiiiiii:i::::::fif:::*:::.,
::=-_-_-_-_-_-_-_, -_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_---- -------
-.. Summery
c.Nit
control test ==== decreaSe
z..
-Chest (75%) ' .161375 3715:
Skies
Sides (37%) 57..5 37.25 :.. 37%
1
2 A summary chart is provided below showing a summarized version of the
data obtained in
3 the impedance tests described above.
18
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Mean Decrease in impedance
=1:1R*1
test
1
2 These tests indicate that the impedance drops after the skin preparation
device made in
3 accordance to the embodiments described herein, has been applied to the
skin and removed.
4 Even though numerous characteristics and advantages of the embodiments
and methods
described in the foregoing description and figures, these descriptions are
illustrative only.
6 Changes may be made in detail, especially in matters of size, shape, and
orientation of parts
7 within the principles of the invention to the full extent indicated by
the broad general
8 meaning of the terms in which the appended claims are attached.
Furthermore, the terms
9 "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
11 modifications and changes would occur to those skilled in the art, it is
not desired to limit the
12 scope of the embodiments described herein. Accordingly all suitable
modifications and
13 equivalents may be resorted to, falling within the scope of the subject
embodiments.
19
