U.S. patent application number 15/771841 was filed with the patent office on 2018-11-08 for tissue treatment device and method.
The applicant listed for this patent is Lorain County Community College Innovation Foundation. Invention is credited to John Buan, Russell S. Donda, Thomas E. Lash, Sundar Manickam, Richard L. Middaugh, Timothy Wojciechowski, John D. Wolter.
Application Number | 20180318165 15/771841 |
Document ID | / |
Family ID | 58631121 |
Filed Date | 2018-11-08 |
United States Patent
Application |
20180318165 |
Kind Code |
A1 |
Donda; Russell S. ; et
al. |
November 8, 2018 |
TISSUE TREATMENT DEVICE AND METHOD
Abstract
A controlled pressure device includes a reactor housing element,
a reactor, and a cosmetic liquid or cream. The reactor housing
element is configured to at least partially define an at least
substantially air-tight enclosed volume around a tissue site when
fixed in space in relation to the tissue site. The reactor is
positioned in the enclosed volume and is configured to react with a
selected gas found in air. The reactor consumes the selected gas
within the enclosed volume. The cosmetic liquid or cream is also
located in the enclosed volume.
Inventors: |
Donda; Russell S.; (North
Royalton, OH) ; Manickam; Sundar; (Avon Lake, OH)
; Middaugh; Richard L.; (Rocky River, OH) ; Lash;
Thomas E.; (Chardon, OH) ; Wojciechowski;
Timothy; (Westlake, OH) ; Wolter; John D.;
(Berea, OH) ; Buan; John; (Maple Grove,
MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Lorain County Community College Innovation Foundation |
Elyria |
OH |
US |
|
|
Family ID: |
58631121 |
Appl. No.: |
15/771841 |
Filed: |
October 28, 2016 |
PCT Filed: |
October 28, 2016 |
PCT NO: |
PCT/US16/59291 |
371 Date: |
April 27, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62248422 |
Oct 30, 2015 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 1/36014 20130101;
A61M 2205/051 20130101; A61M 27/00 20130101; A61M 35/30 20190501;
A61F 13/00063 20130101; A61H 2201/165 20130101; A61N 2005/0652
20130101; A61F 13/00 20130101; A61M 37/00 20130101; A61M 1/0066
20130101; A61M 1/009 20140204; A61N 5/0616 20130101; A61M 2205/054
20130101; A61M 1/0084 20130101; A61F 13/02 20130101; A61F 13/00068
20130101; A61H 9/0057 20130101; A61H 2201/105 20130101; A61M
2205/0277 20130101; A61H 2201/0278 20130101; A61H 2201/1238
20130101; A61M 2205/364 20130101; A61N 1/0492 20130101; A61H 9/0071
20130101; A61M 1/0088 20130101; A61M 1/0003 20130101 |
International
Class: |
A61H 9/00 20060101
A61H009/00 |
Claims
1. A controlled pressure device for tissue treatment, the device
comprising: a reactor housing element configured to at least
partially define an at least substantially air-tight enclosed
volume around a tissue site when fixed in space in relation to the
tissue site; and a reactor positioned in the enclosed volume and
configured to react with a selected gas found in air, wherein the
reactor consumes the selected gas within the enclosed volume.
2. The controlled pressure device of claim 1, further comprising a
cosmetic liquid or cream located in the enclosed volume.
3. The controlled pressure device of claim 2, wherein the cosmetic
liquid or cream includes at least one of a moisturizer,
dimethylaminoethanol (DMAE), Acetyl hexapeptide-8, Acetyl
hexapeptide-3, retinol, ubiquinone, dithiolane-3-pentanic acid,
alpha-hydroxy acid, alpha lipoic acid, salicylic acid,
hydrocortisone, topical botulinum cream, and hyaluronic acid.
4. The controlled pressure device of claim 2, further comprising a
pad impregnated with the cosmetic liquid or cream.
5. The controlled pressure device of claim 1, wherein the reactor
includes a reactor substrate, a reducing agent, a binder, and an
electrolyte solution.
6. The controlled pressure device of claim 1, further comprising a
release layer adhered to a lower surface of the reactor housing
element, wherein the release layer provides an air-tight barrier
such that air is precluded from access to the reactor until after
the release layer is removed from the reactor housing element.
7. (canceled)
8. The controlled pressure device of claim 1, further comprising a
package including a plurality of air-tight barriers selectively
removable from the package, wherein the reactor is positioned
within the package and the selected gas is precluded from access to
the reactor until after at least one of the plurality of air-tight
barriers is removed from the package.
9. The controlled pressure device of claim 1, wherein the reactor
includes a plurality of reactor elements is-configured to cycle gas
pressure in the enclosed volume, wherein the plurality of reactors
includes a first reactor element configured to begin consuming
oxygen after being exposed to oxygen for a first period of time and
a second reactor element configured to begin consuming oxygen after
being exposed to oxygen for a second period of time, which is
greater than the first period of time.
10. (canceled)
11. (canceled)
12. (canceled)
13. The controlled pressure device of claim 1, further comprising a
skin contacting element including a skin contacting side for
contacting a subject's skin, wherein the skin contacting element
includes an opening extending through the skin contacting element
from the skin contacting side to an interface side, which is
opposite to the skin contacting side.
14. The controlled pressure device of claim 13, wherein the reactor
housing element affixes to the interface side of the skin
contacting element providing a substantially air-tight seal between
the reactor housing element and the skin contacting element.
15. The controlled pressure device of claim 14, further comprising
an air-tight barrier selectively removable from the reactor housing
element, wherein the reactor is positioned between the reactor
housing element and the air-tight barrier and the selected gas is
precluded from access to the reactor until after the air-tight
barrier is removed from the reactor housing element.
16. (canceled)
17. The controlled pressure device of claim 1, wherein the reactor
housing element includes a hood and a lower peripheral section at
least partially surrounding the hood, the reactor housing element
being configured such that a downward force on the hood results in
an outward force on the lower peripheral section.
18. The controlled pressure device of claim 1, further comprising a
liquid impermeable--air permeable membrane interposed between the
reactor and the tissue site when the reactor housing element is
fixed in space in relation to the tissue site.
19. The controlled pressure device of claim 1, further comprising a
cosmetic liquid or cream located in the enclosed volume and a
liquid impermeable--air permeable membrane interposed between the
reactor and the cosmetic liquid or cream.
20. The controlled pressure device of claim 1, further comprising a
pressure relief valve on the reactor housing element, wherein the
pressure relief valve allows for selective communication between
the enclosed volume and ambient.
21. The controlled pressure device of claim 1, wherein the
controlled pressure device is configured to allow an operator to
change the size of the enclosed volume while the reactor consumes
the selected gas in the enclosed volume.
22. (canceled)
23. (canceled)
24. The controlled pressure device of claim 1, wherein the reactor
is configured having a predetermined scavenging capacity (SC) for
the selected gas, wherein the enclosed volume has a determined
volume (DV), the controlled pressure device is configured to have a
maximum leakage rate (LR) for air entering the enclosed volume, and
the controlled pressure device is configured to a minimum wear time
(MWT) wherein: SC>DV*(% of selected gas in air)+LR*(% of
selected gas in air)*MWT.
25. The controlled pressure device of claim 1, wherein the reactor
is one or any combination of a zinc-based chemical pump, an
electro-chemical pump, a vacuum-on-demand device, an electrolyzer,
a pressure-reducing solid state device, an oxygen absorbing zinc or
iron packet, a zinc-air battery, a zinc-air battery component and a
getter of zirconium titanium, vanadium iron, lithium, lithium
metal, magnesium, calcium, lithium barium combinations.
26. The controlled pressure device of claim 1, wherein the reactor
is configured to consume ambient oxygen to heat cosmetic liquid or
cream in the enclosed volume.
27. The controlled pressure device of claim 1, wherein the reactor
is configured to consume oxygen within the enclosed volume to
reduce gas pressure within the enclosed volume, and the controlled
pressure device further comprising an additional reactor configured
to consume ambient oxygen to heat cosmetic liquid or cream in the
enclosed volume.
28. (canceled)
29. (canceled)
30. The controlled pressure device of claim 1, further comprising a
skin massaging element positioned in the enclosed volume, wherein
the skin massaging element is positioned adjacent to the tissue
site when the skin contacting side of the skin contacting element
is in contact with a subject's skin, wherein the skin massaging
element includes an undulated bottom surface.
31. (canceled)
32. The controlled pressure device of claim 30, wherein the skin
massaging element is a membrane including openings through which
cosmetic liquid or cream passes.
33-72. (canceled)
Description
[0001] This application claims priority to U.S. Provisional
Application Ser. No. 62/248,422 filed on Oct. 30, 2015, the
entirety of which is expressly incorporated by reference.
BACKGROUND
[0002] The pores of the skin can become occluded with impurities.
Negative pressure has been used to generate a partial vacuum to aid
in removing impurities from the pores. Negative pressure is a term
used to describe a pressure that is below normal atmospheric
pressure. At room temperature and at sea level, a defined volume of
air contains molecules moving in random directions, and these
moving molecules exert a force that is equal to the normal
atmospheric pressure of approximately 760 mmHg (about 1 bar).
Negative pressure has been achieved by removing air from an area of
interest, for example at a tissue site via a suction pump.
[0003] Devices for the generation of topical negative pressure at
the surface of a person's skin have been used for many hundreds of
years to treat humans. For example, the cupping technique, which
relates to positioning a mouth of a rigid vessel containing hot air
on a human's skin, is a well-known technique. Spring powered
syringes and suction cups are other mechanical techniques that have
been used for generating a partial vacuum on human tissue. In
common with cupping, such other mechanical techniques have offered
a limited topical negative pressure duration and little or no range
of neutral to positive pressures. This is due to design constraints
and that the cupping technique and other mechanical techniques are
not self-contained and can hinder a user's mobility.
[0004] To enable a more prolonged application of topical negative
pressure, powered systems, which include a vacuum generation source
such as a pump, have been developed and many examples of such
systems are used today for skin treatments and restorative purposes
like the temporary removal of wrinkles. Many of these systems,
however, are not convenient for users. Such known systems can be
large, heavy, noisy, uncomfortable, and not simple for users to
apply and initiate a controlled pressure condition. Such known
systems also rely on an outside power or vacuum source to create
topical negative pressure conditions.
SUMMARY
[0005] In view of the foregoing, a controlled pressure device
includes a reactor housing element and a reactor. The reactor
housing element is configured to at least partially define an at
least substantially air-tight enclosed volume around a tissue site
when fixed in space in relation to the tissue site. The reactor is
positioned in the enclosed volume and is configured to react with a
selected gas found in air. The reactor consumes the selected gas
within the enclosed volume.
[0006] Another example of a controlled pressure device can include
a reactor housing element and a reactor. The reactor housing
element is configured to at least partially define an at least
substantially air-tight enclosed volume around a tissue site when
fixed in space in relation to the tissue site, and the enclosed
volume has a determined volume (DV). The reactor is positioned in
the enclosed volume and is configured to react with a selected gas
found in air. The reactor consumes the selected gas within the
enclosed volume. The reactor is configured having a predetermined
scavenging capacity (SC) for the selected gas. The controlled
pressure device is configured to have a maximum leakage rate (LR)
when affixed to a subject's skin for air entering the enclosed
volume. The controlled pressure device is also configured to a
minimum wear time (MWT) and is configured according to the
following relationship: SC>DV*(% of selected gas in air)+LR*(%
of selected gas in air)*MWT.
[0007] In view of the foregoing, method of treating a tissue site
includes removing a release layer from a reactor housing element.
The method further includes placing the reactor housing element, a
reactor and a liquid impermeable--air permeable membrane over the
tissue site. The method also includes affixing the reactor housing
element with respect to skin around the tissue site to define an at
least substantially air-tight enclosed volume around the tissue
site.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 is a schematic cross-sectional view of a controlled
pressure device.
[0009] FIG. 2 is a schematic exploded perspective view of a
controlled pressure device.
[0010] FIGS. 3 and 4 are schematic depictions of alternative
reactor embodiments that can be used with the controlled pressure
device shown in FIG. 1.
[0011] FIGS. 5-7 are schematic depictions of powered components
that can be used with the controlled pressure device shown in FIG.
1.
[0012] FIGS. 8 and 9 are flow diagrams depicting a method of
treating a tissue site.
DETAILED DESCRIPTION
[0013] FIG. 1 depicts a controlled pressure device 10 including a
reactor housing element 14 and a reactor 16. The controlled
pressure device 10 can be used in conjunction with a cosmetic
liquid or cream for tissue treatment. For example, the controlled
pressure device 10 can include or be used in conjunction with a
pad, which can be wetted or impregnated with a cosmetic liquid or
cream, and will be hereinafter referred to as a cosmetic pad 18.
The controlled pressure device 10 can be positioned at a tissue
site 20 to enhance tissue treatment including, but not limited to,
wound healing, reduction of skin wrinkles, and other skin maladies.
The reactor housing element 14 is configured to at least partially
define an at least substantially air-tight enclosed volume 22
around the tissue site 20 when affixed in space in relation to the
tissue site 20. FIG. 1 depicts the reactor housing element 14 in
contact with the tissue (e.g., skin) around the tissue site 20,
however, the reactor housing element 14 can be fixed in space in
relation to the tissue site 20 without being in direct contact with
the tissue around the tissue site 20. For example, an intermediate
membrane or layer, such as a skin contacting element 24 (FIG. 2),
could be interposed between the reactor housing element 14 and the
tissue (e.g., skin) around the tissue site 20, although the reactor
housing element 14 is fixed in space in relation to the tissue site
20. The reactor 16 positioned in the enclosed volume 22 reacts with
a selected gas found in air and consumes the selected gas within
the enclosed volume 22. The cosmetic liquid or cream is also
located in the enclosed volume 22.
[0014] With reference to FIG. 2, the controlled pressure device 10
can includes the skin contacting element 24. The skin contacting
element 24 includes a skin contacting side 30 that is adherable to
a subject's skin and an interface side 32, which is opposite to the
skin contacting side. In the illustrated embodiment, the skin
contacting element 24 is shown as a separate element from the
reactor housing element 14. In an alternative arrangement, the skin
contacting element 24 can be provided as part of the reactor
housing element 14, e.g., the skin contacting element 24 can be
integrally formed with the reactor housing element 14 or connected
with the reactor housing element 14 at the manufacturing facility.
The skin contacting element 24 can be made from a thin sheet-like
membrane, for example using a roll-to-roll process. In the
illustrated embodiment, the skin contacting element 24 also
includes openings 34 extending through the skin contacting element
24 from the skin contacting side 30 to the interface side 32. The
openings 34 can be located over the tissue site 20. In conjunction
with a skin contacting gasket 36, the skin contacting element 24 is
configured to provide a seal around the tissue site 20 to allow for
topical negative pressure to be applied at the tissue site 20. If
desired, the skin contacting element 24 can include an opening that
is larger than each of the openings 34 depicted in FIG. 2. In this
example, the opening 34 can be dimensioned to fit around the tissue
site 20. The opening 34 in this example can be similarly shaped to
the cosmetic pad 18 so that the skin contacting element 24 and the
skin contacting gasket 36 provide a seal around the tissue site 20
(FIG. 1) and the cosmetic pad 18. If desired, the skin contacting
element 24 need not include the opening(s) 34, and in this example,
the cosmetic pad 18 can be positioned beneath the skin contacting
side 30 so as to come in contact with the subject's skin at the
tissue site 20.
[0015] Both the skin contacting side 30 and the interface side 32
are generally flat or planar. In the illustrated embodiment, the
interface side 32 is the upper side of the skin contacting element
24 and the skin contacting side 30 is the lower side of the skin
contacting element. Adhesive 38 (depicted schematically in FIG. 2)
can provided on the skin contacting side 30 to allow the skin
contacting side 30 to adhere to the subject's skin around the
tissue site 20.
[0016] The skin contacting gasket 36 can be provided on the skin
contacting side 30 of the skin contacting element 24 or simply be
positioned between the skin contacting side 30 and the subject's
skin. The skin contacting gasket 36 can be made from a hydrogel to
further promote sealing around the tissue site 20 to promote the
topical negative pressure at the tissue site 20.
[0017] A release layer 40 can be provided with the controlled
pressure device 10 to protect the skin contacting side 30 of the
skin contacting element 24. The release layer 40 can be similar to
known release layers and include an upper side 42 that is
releasable from the skin contacting side 30 of the skin contacting
element 24. The release layer 40 also includes a lower surface 44
opposite the upper side 42. As mentioned above, the reactor 16
reacts with a selected gas found in air and consumes the selected
gas within the enclosed volume 22. In some embodiments, the release
layer 40 can provide an air-tight barrier such that air is
precluded from access to the reactor 16 until after the release
layer 40 is removed from the skin contacting element 24. In
embodiments where the skin contacting element 24 may not be
provided, the release layer 40 can cooperate with the reactor
housing element 14 in a similar manner, and the release layer 40
can provide an air-tight barrier such that air is precluded from
access to the reactor 16 until after the release layer 40 is
removed from the reactor housing element 14.
[0018] With reference back to FIG. 1, the reactor housing element
14 at least partially defines the enclosed volume 22 around the
tissue site 20 when fixed in space in relation to the tissue site
20. With reference to the embodiment depicted in FIG. 2, the
reactor housing element 14 cooperates with the skin contacting
element 24 to at least partially define the enclosed volume 22 (see
FIG. 1) around the tissue site 20, for example, when the skin
contacting side 30 of the skin contacting element 24 is in contact
with and adhered to the subject's skin and the reactor housing
element 14 is affixed to the skin contacting element 24. The
reactor housing element 14 can be formed with a hood 50 and a lower
peripheral section 52 that at least partially surrounds the hood
50. In the illustrated embodiment, the lower peripheral section 52
entirely surrounds the hood 50, which is raised in relation to the
lower peripheral section 52 so as to define the enclosed volume 22
around the tissue site 20. The reactor housing element 14 can also
be formed without the hood 50, i.e., the reactor housing element 14
could initially be planar. Similar to the skin contacting element
24, the reactor housing element 14 can be made from a thin
sheet-like membrane, for example using a roll-to-roll process. The
reactor housing element 14 can be made from a flexible material
that is similar to or the same flexibility as the skin contacting
element 24, which allows the controlled pressure device 10 to
conform to the skin around the tissue site 20. When the reactor
housing element 14 is affixed to the skin contacting element 24,
the reactor 16 is located between the reactor housing element 14
and the cosmetic pad 18 and the skin contacting element 24. Since
the reactor housing element 14 is made from a flexible material in
this example, the section of the reactor housing element 14 that is
not in contact with the skin contacting element 24 is raised or
offset from the tissue site 20 so as to form the hood 50.
[0019] The reactor housing element 14 can be made from a material
that is air impermeable so that air is precluded or greatly
inhibited from entering into the enclosed volume 22 as the reactor
16 consumes a selected gas within the enclosed volume thus reducing
gas pressure within the enclosed volume. The reactor housing
element 14 could also be made from materials that are impervious to
particular gasses (e.g., oxygen) and pervious to other gases (e.g.,
nitrogen). The reactor housing element 14 can be formed of a
material that is at least partially gas permeable for selected
gasses (e.g., nitrogen gas permeable) to exhaust the selected gas
from the tissue site 20 to atmosphere. The reactor housing element
14 includes a lower surface 56. An adhesive 58 (depicted
schematically in FIG. 2) can be applied to the lower surface 56.
With reference to FIG. 1, the lower surface 56 contacts the skin
around the tissue site 20 and the adhesive 58 adheres the reactor
housing element 14 to the skin around the tissue site 20. A reactor
housing element gasket 60, which can be a hydrogel gasket similar
to the skin contacting gasket 36 described above, can be provided
between the lower surface 56 of the reactor housing element 14 and
the skin to further seal between the reactor housing element 14 and
the skin to preclude air migration between the interface between
the lower surface 56 the skin.
[0020] With reference to FIG. 2, the reactor housing element 14 can
affix to the interface side 32 of the skin contacting element 24
providing a substantially air-tight seal between the reactor
housing element 14 and the skin contacting element 24. The adhesive
58 applied to the lower surface 56 can affix the reactor housing
element 14 to the skin contacting element 24. The reactor housing
element gasket 60 can be provided between the lower surface 56 of
the reactor housing element 14 and the interface side 32 of the
skin contacting element 24 to further seal between the reactor
housing element 14 and the skin contacting element 24 to preclude
air migration between the interface between the lower surface 56 of
the reactor housing element 14 and the interface side 32 of the
skin contacting element 24.
[0021] The reactor 16 is positioned in the enclosed volume 22 and
is configured to react with one of more selected gases (e.g.,
nitrogen, oxygen, carbon dioxide) found in air to consume the
selected gas within the enclosed volume 22, which can reduce gas
pressure within the enclosed volume 22. The reduction in gas
pressure within the enclosed volume 22 can result in a partial
vacuum being formed in the enclosed volume 22, which can result in
a downward force (in the direction of arrow 70) being applied to
the hood 50 of the reactor housing element 14. The reactor housing
element 14 can be configured such that the downward force (in the
direction of arrow 70) on the hood 50 (or the top of the reactor
housing element 14) results in an outward force (normal to the
direction of arrow 70) on the lower peripheral section 52. Since
the reactor housing element 14 is affixed to the skin contacting
element 24, which is adhered to the subject's skin, or directly to
the skin (see FIG. 1) the outward force in the direction normal to
arrow 70 can result in small strains and stresses being applied to
the patient's skin around the tissue site 20. These strains and
stresses being applied to the patient's skin can be beneficial for
the introduction of the cosmetic liquid or cream impregnated within
the cosmetic pad 18 as well as providing a massaging effect of the
skin. Where the reactor housing element 14 is made from a
relatively more rigid material with respect to the skin contacting
element 24, for example, flexible regions 74 can be provided in the
lower peripheral section 52 to facilitate outward movement of the
reactor housing element 14 with respect to the tissue site 20 to
allow for the small strains and stresses to be applied to the
subject's skin at the tissue site 20.
[0022] The reactor 16 is positioned in the enclosed volume 22 and
is configured to react with the selected gas (e.g., nitrogen,
oxygen, carbon dioxide) found in air. As the reactor 16 consumes
the selected gas within the enclosed volume 22, the gas pressure
within the enclosed volume 22 is reduced. For example, where the
reactor 16 consumes oxygen, there can be an approximate 20%
reduction from atmospheric pressure in the enclosed volume 22. An
example of a reactor 16 that can be used in the controlled pressure
device is described in US 2014/0109890 A1, which is incorporated by
reference herein. US 2014/0109890 A1 describes an oxygen based
heater; however, the oxygen based heater described in US
2014/0109890 A1 can be used as the reactor 16 to consume oxygen
within the enclosed volume 22 thus producing a partial vacuum
within the enclosed volume 22. In this example, the reactor 16
includes a reducing agent, a binding agent on a reactor substrate
80 and an electrolyte solution, which can be provided in an
electrolyte impregnated pad 82. The reducing agent on the reactor
substrate 80 can be zinc, aluminum, or iron, for example.
[0023] As mentioned above, the release layer 40 can operate as an
air-tight barrier such that the selected gas (e.g., nitrogen,
oxygen, carbon dioxide) is precluded from access to the reactor 16
until after the air-tight barrier, which in this instance is the
release layer 40, is removed from the controlled pressure device
10. Alternatively, the controlled pressure device 10 can include a
package, which is shown in FIG. 2 as including an upper layer 94
and a lower layer 96. The upper layer 94 affixes to the lower layer
96 enclosing the reactor substrate 80 in between the upper layer 94
and the lower layer 96 so as to provide an air-tight seal so that
the selected gas is precluded from access to the reactor 16. In
this example including the package, the upper layer 94 or the lower
layer 96 can operate as an air tight barrier in that removal of the
upper layer 94 from the lower layer 96, or vice versa, allows the
selected gas access to the reactor 16 so that the selected gas can
be consumed by the reactor 16. Alternatively, at least one of the
layers (the lower layer 96 in the illustrated embodiment) can
include openings 98 and a seal layer 102 can be affixed in an
air-tight manner to the lower layer 96 covering the openings 98.
Removal of the seal layer 102 from the lower layer 96 exposes the
reactor 16 to the selected gas, which allows the reactor to consume
the selected gas within the enclosed volume 22. The surface area of
the openings 98 can be appropriately sized to control the flow of
the selected gas through the openings to sustain the chemical
reaction of the reactor 16 to the desirable time limit for
maintaining topical negative pressure on the tissue site 20 for the
desired duration. Moreover, multiple seal layers 102 can be
provided so that removal of one or a selected few of the seal
layers (while other seal layers are still affixed to the lower
layer 96) can also be provided to limit the flow of the selected
gas toward the reactor 16. Additionally, to further control the
pressure within the enclosed volume, the controlled pressure device
10 can include a pressure relief valve 106 on the reactor housing
element 14. The pressure relief valve 106 can allow for selected
communication between the enclosed volume 22 and ambient. The
pressure relief valve 106 can be operated when a predetermined
pressure differential exists between the enclosed volume 22 and
ambient. Moreover, the pressure relief valve 106 can be configured
to open when the temperature within the enclosed volume exceeds a
desired predetermined temperature.
[0024] To also further control the pressure within the enclosed
volume 22, the controlled pressure device 10 can be configured to
allow an operator to change the size of the enclosed volume 22
while the reactor 16 consumes the selected gas in the enclosed
volume, thus varying the gas pressure within the enclosed volume
22. For example, a tab 110 can be affixed to the reactor housing
element 14, and the operator can pull the tab 110 to move the
reactor housing element away from the tissue site 20. In FIG. 2,
the tab 110 is affixed to the hood 50. When the enclosed volume 22
is under negative pressure, the hood 50 will tend to travel toward
the tissue site 20. By pulling on the tab 110, the hood 50 can be
moved away from the tissue site 20 and air can enter the enclosed
volume 22, for example by leaking past the gasket 36 or a small
pre-configured leakage path can be provided. Air entering the
enclosed volume 22 can increase the pressure within the enclosed
volume 22 until the selected gas (e.g., oxygen) is consumed by the
reactor 16. Such a configuration can allow for a cycling of
pressure in the enclosed volume 22.
[0025] The controlled pressure device 10 can also be packaged such
that the reactor housing element 14 and the reactor 16 are packaged
separately from the skin contacting element 24, for example. In
such an embodiment, a reactor housing element release layer 120 can
be provided. The reactor housing element 14 release layer 120 can
be similar to the release layer 40 having an upper side 122 that is
releasable from the lower surface 56 of the reactor housing element
14. The reactor housing element release layer 120 further includes
a lower surface 124 that is opposite to the upper side 122. The
reactor housing element release layer 120 can also be affixed to
the lower layer 96, so that removal of the reactor housing element
release layer 120 from the reactor housing element 14 results in
removal of the lower layer 96 from the upper layer 94, thus
exposing the reactor 16 to air. Alternatively, the reactor housing
element release layer 120 can be affixed to the seal layer 102 such
that removal of the reactor housing element release layer 120 from
the reactor housing element 14 results in removal of the seal layer
102 from the lower layer 96, thus exposing the reactor 16 to air
via the openings 98 provided in the lower layer 96.
[0026] Where the controlled pressure device 10 is packaged where
the reactor housing element 14 and the reactor 16 are separate from
the skin contacting element 24, an upper skin contacting element
release layer (not shown) can be provided. The upper skin
contacting element release layer can be similar to the release
layer 40. Alternatively, no upper skin contacting element release
layer need be provided.
[0027] The controlled pressure device 10 further includes a liquid
impermeable-air permeable membrane 150 interposed between the
reactor 16 and the cosmetic liquid or cream, which is impregnated
in the cosmetic pad 18 in the illustrated embodiment. The size
(area) of the liquid impermeable-air permeable membrane 150 can
depend on the location of the liquid impermeable-air permeable
membrane 150 within the controlled pressure device 10. If the
cosmetic liquid or cream were to come in contact with the reactor
16, the chemical reaction of the reactor 16 when coming in contact
with the selected gas may be detrimentally impacted. As such, the
liquid impermeable-air permeable membrane 150 allows air flow
within the enclosed volume 22 while precluding the cosmetic liquid
or cream from coming into contact with the reactor 16.
[0028] The liquid impermeable-air permeable membrane 150 can be
located in different locations on the controlled pressure device
10. In one example depicted in FIG. 2, the liquid impermeable-air
permeable membrane 150 can be located between the reactor substrate
80 and the lower layer 96 making up the air-tight package for the
reactor 16. So, once the lower layer 96 (or the seal layer 102) is
removed, air can gain access to the reactor 16, but the cosmetic
liquid or cream would be precluded from traveling through the
liquid impermeable-air permeable membrane 150. In another example,
the liquid impermeable-air permeable membrane 150 can be located
between the lower layer 96 (or the seal layer 102) making up the
air-tight package for the reactor 16 and the cosmetic liquid or
cream, which can be impregnated in the cosmetic pad 18. More
generally, and as depicted in FIG. 1, the liquid impermeable-air
permeable membrane 150 can be located between the reactor 16 and
the cosmetic liquid or cream, which would be impregnated in the
cosmetic pad 18. As depicted in FIG. 1, the liquid impermeable-air
permeable membrane 150 can be connected with the reactor housing
element 14 and preclude the cosmetic liquid or cream from passing
through the liquid impermeable-air permeable membrane 150 while
allowing air to travel through the liquid impermeable-air permeable
membrane 150 so that the selected gas can be removed from the
enclosed volume 22. If desired, the liquid impermeable-air
permeable membrane 150 could surround the reactor 16 and preclude
the cosmetic liquid or cream from passing through the liquid
impermeable-air permeable membrane 150 while allowing air to travel
through the liquid impermeable-air permeable membrane 150.
[0029] In an embodiment where the reactor housing element 14 and
the reactor 16 are packaged separately from the skin contacting
element 24, the release layer 40 can be removed from the skin
contacting element 24. The skin contacting element 24 can be
pressed against a subject's skin around the tissue site 20 and
adhesive 38 on the skin contacting side of the skin contacting
element 24 can adhere the skin contacting element 24 to the
subject's skin. The skin contacting gasket 36 can surround the
tissue site 20 to promote an air-tight seal between the skin
contacting element 24 and the subject's skin around the tissue site
20. The cosmetic liquid or cream, which is located within the
cosmetic pad 18 in the illustrated embodiment, is then brought into
contact with the tissue site 20 by traveling through the openings
34.
[0030] The reactor housing element release layer 120 can be removed
from the reactor housing element 14. Removal of the reactor housing
element release layer 120 from the reactor housing element 14 can
expose the reactor 16 to air by removal of the lower layer 96, the
seal layer 102, or the reactor housing element release layer 120
may be affixed in an air-tight manner to the reactor housing
element 14 so that air is precluded from access to the reactor 16
until after the reactor housing element release layer 120 is
removed from the reactor housing element 14. After removal of the
reactor housing element release layer 120 from the reactor housing
element 14, the lower surface 56 of the reactor housing element 14
can be brought in contact with an upper surface 152 of the liquid
impermeable-air permeable membrane 150, which can have its lower
surface 154 affixed to the interface side 32 of the skin contacting
element 24. Alternatively, where the liquid impermeable-air
permeable membrane 150 is positioned between the reactor substrate
80 and the lower layer 96, the lower surface 56 of the reactor
housing element 14 can be brought in contact with the interface
side 32 of the skin contacting element 24. When the reactor housing
element 14 is brought into contact with the liquid impermeable-air
permeable membrane 150 and/or the skin contacting element 24, the
reactor 16 consumes the selected gas found within the enclosed
volume 22. A chemical reaction occurs where heat can be generated,
and a pressure reduction with respect to atmospheric pressure
occurs by consumption of the selected gas. The reactor 16 can heat
the enclosed volume 22 above ambient, which can provide a
therapeutic effect for use with some cosmetic liquids or creams. In
addition, suction can be applied to the tissue site thus stretching
the subject's skin at the tissue site, which can also have a
therapeutic effect with certain cosmetic liquids or creams.
Moreover, the application of topical negative pressure at a
particular tissue site can also have a therapeutic effect.
[0031] The controlled pressure device 10 can be designed with
certain parameters. As an example, assuming the tissue site 20 of
about 10 cm.times.20 cm and an offset of the hood 50 (or the top of
the reactor housing element 14) of about 2.5 cm from the tissue
site 20 results in the enclosed volume 22 of 500 mL. Assuming that
the cosmetic liquid or cream and the solid components of the
cosmetic pad 18 in addition to the reactor 16 and any other solid
components (e.g., the liquid impermeable-air permeable membrane
150) within the enclosed volume 22 account for 100 mL within the
enclosed volume 22, this leaves 400 mL air in the enclosed volume.
400 mL of air results in about 320 mL of nitrogen and 80 mL of
oxygen within the enclosed volume 22 prior to the application of a
partial vacuum resulting from the reactor 16 consuming a selected
gas in the air within the enclosed volume 22. One gram (1 g) of
zinc (Zn) will consume about 170 mL at standard temperature and
pressure (STP) of oxygen (02), which is the amount of oxygen in
about 850 mL (STP) of normal dry air. Although the skin contacting
gasket 36 and the reactor housing element gasket 60 can be
provided, there will likely be leakage of ambient air into the
enclosed volume 22 past the gaskets 36, 60 and possibly diffusion
through the reactor housing element 14 and the skin contacting
element 24. For the purposes of this disclosure, both leakage past
interfaces (e.g., leakage around the skin contacting gasket 36) and
diffusion (e.g., diffusion through the reactor housing element 14)
will be referred to as leakage. The gaskets 36, 60, the skin
contacting element 24 and reactor housing element 14 are configured
to have a maximum leakage rate of air into the enclosed volume 22
from ambient. For example, a maximum leakage rate of 1 mL
(STP)/hour of air into the enclosed volume from ambient results in
0.2 mL (STP) of oxygen/hour. Since 1 g of zinc consumes 170 mL of
oxygen (STP), 1 g of zinc provides an adequate amount of a reducing
agent to result in a 20% reduction from normal atmospheric pressure
within the enclosed volume 22 for an extended period of time, e.g.,
well over 72 hours. The controlled pressure device 10 will likely
be worn for a much shorter period of time and the tissue site 20
being treated may be much smaller than 10 cm.times.20 cm. It can be
seen that a very small reactor 16, e.g., one able to accommodate
less than 1 g of zinc, can be used in the controlled pressure
device 10.
[0032] In view of the foregoing, the controlled pressure device 10
can be configured as follows. The reactor 16 can be configured to
have a predetermined scavenging capacity ("SC"), which relates to
the volume of the selected gas that the reactor 16 is configured to
consume. For example, as mentioned above 1 g of zinc will consume
about 170 mL of oxygen (STP), so the scavenging capacity would be
170 mL. The enclosed volume 22 can have a determined volume ("DV")
based on the area of the tissue site 20, the size of the reactor
housing element 14, the offset of the hood 50 (or top of the
reactor housing element 14) from the tissue site 20, taking into
account the cosmetic liquid or cream and the solid components of
the cosmetic pad 18 in addition to the reactor 16 and any other
solid components within the enclosed volume 22. For example, the
determined volume of 400 mL was discussed above. Also, the
controlled pressure device 10 can be configured to have a maximum
leakage rate (LR) for air entering the enclosed volume 22. In
addition, the controlled pressure device 10 can be configured to
have a minimum wear time ("MWT"), which relates to the minimum
amount of time that the controlled pressure device 10 is configured
to be worn. Assuming that it is desirable to have the reactor 16
consume, or scavenge, the selected gas for the entire minimum wear
time, the controlled pressure device can be configured in view of
the following relationship:
SC>DV*(% of selected gas in air)+LR*(% of selected gas in
air)*MWT.
[0033] The scavenging capacity can be determined to provide a
relatively small reactor 16 in relation to the reactor housing
element 14 and the tissue site 20 to be treated. The determined
volume can be determined to provide a relatively small reactor 16
and reactor housing element 14 in view the tissue site 20 to be
treated. The maximum leakage rate for air entering the enclosed
volume 22 should be reduced as much as is practical; however, there
may be some circumstances in which a predetermined amount of
leakage is desirable, for example where cycling of pressure within
the enclosed volume 22 is desired. For example, the maximum leakage
rate for air entering the enclosed volume 22 can be less than 10
mL/hour, and preferably less than 1 or 2 mL/hr. The minimum wear
time can be determined based on the desired amount of time the
topical negative pressure is to be applied to the tissue site 20.
It may be desirable to include a safety factor (e.g., a multiplier
on the right side of the relationship above) to accommodate for
manufacturing tolerances, differences among tissues sites and
subjects placing the controlled pressure device 10 on the tissue
site 20.
[0034] As the reactor 16 consumes the selected gas found in air
within the enclosed volume 22, an exothermic reaction occurs such
that there is an increase in temperature of the reactor 16. As
such, the reactor 16 can operate as a heater to heat the cosmetic
liquid or cream impregnated in the cosmetic pad 18. This can change
the viscosity of the cosmetic liquid or cream, which can facilitate
entry of the cosmetic liquid or cream into skin pores.
[0035] The reactor housing element 14 could also be provided with a
removable section 160 that when removed could provide ambient air
access to the reactor 16 or an additional reactor located beneath
the reactor housing element 14. For example, the removable section
160 can be affixed to the upper layer 94 of the package in which
the reactor substrate 80 is located. Removal of the removable
section 160 can result in removal of at least a portion of the
upper layer 94 thus exposing the reactor substrate 80 to ambient
air, which would result in an exothermic reaction. Alternatively,
an additional reactor could be located beneath the reactor housing
element 14 and removal of the removable section 160 can result in
removal of at least a portion of the package (similar to the
package made up of the upper layer 94 and the lower layer 96) thus
exposing the additional reactor to ambient air. The additional
reactor can also heat the gas in the enclosed volume 22, which can
heat the tissue site 20.
[0036] Different types of reactors could be used to provide topical
negative pressure inside the enclosed volume 22 of the controlled
pressure device 10. FIG. 3 depicts multiple reactor substrates or
multiple regions on the same reactor substrate, which are depicted
as reactor elements 80a, 80b and 80c each having different chemical
properties and/or characteristics. For example, the first reactor
element 80a can be configured to begin consuming oxygen after being
exposed to oxygen for a very short (first) period of time t1, e.g.,
nearly instantaneously. The second reactor element 80b can be
configured to begin consuming oxygen after being exposed to oxygen
for a longer (second) period of time t2, and the third reactor
element 80c can be configured to begin consuming oxygen after being
exposed to oxygen for an even longer (third) period of time.
Alternatively, the second reactor element 80b can be configured
with a delayed reaction time to begin consuming oxygen after the
first reactor element 80a has been exhausted and no longer consumes
oxygen. Similarly, the third reactor element 80c can be configured
with a delayed reaction time to begin consuming oxygen after the
first reactor element 80a and the second reactor element 80b have
both been exhausted and no longer consume oxygen. Such a
configuration can allow for a cycling of pressure in the enclosed
volume 22.
[0037] In lieu of the reactor 16 made up of the reactor substrate
80, the reactor 16 may be one or any combination of a zinc-based
chemical pump, electro-chemical pumps, vacuum-on-demand devices
(referred to herein as VOD), electrolyzers, pressure-reducing solid
state devices, oxygen absorbing iron packets, or getters of
zirconium titanium, vanadium iron, lithium, lithium metal,
magnesium, calcium, lithium barium combinations, zinc-air battery,
zinc-air battery components or other materials highly reactive with
the selected gases, for example, nitrogen, carbon dioxide and
oxygen gases found in skin tissue environments.
[0038] FIG. 4 depicts another reactor 226 that can be used in place
of the reactor 16 shown in FIG. 1. WO 2015/054040 A1, which is
incorporated by reference, describes an electrochemical cell that
is adapted to consume gases, i.e., air or its gaseous non-noble
constituents, within an enclosure via an electrochemical reaction.
This consumption of gas within a sealed enclosure forms a partial
vacuum. The controlled pressure device 10 can include such a
reactor 226 having an electrochemical cell 228 that lowers the
pressure within the enclosed volume 22 through an electrochemical
reaction that takes place when a voltage is applied to the
electrochemical cell 228 by a power source 230 (depicted
schematically in FIG. 4). Operation of electrochemical cell 228 in
this example can also be achieved by controlling the current
supplied to the electrochemical cell 228 by the power source 230,
for example by providing a switch 232 that can be operated by the
user. The power source 230 can be located in the enclosed volume 22
or be provided outside the controlled pressure device 10 (e.g. on
the reactor housing element 14). The switch 232 can be provided
outside the controlled pressure device 10 (e.g. on the reactor
housing element 14).
[0039] In an example where the reactor is a VOD device, a VOD is a
solid state electrochemical cell, which when charged with a low
voltage, produces a highly reactive material that captures gases
present in the atmosphere and when sealed in an air tight system
can form a partial vacuum. In a VOD device, metal is deposited to
grow dendrites as a voltage is applied across electrodes of the VOD
device and lithium salt electrolyte, charging the VOD device.
Similar to charging a battery, electrons are moved from layer to
layer to form metallic lithium.
[0040] In an example where the reactor is a getter, a getter, as
known in the art, is a deposit of reactor material that is used for
initiating and maintaining a partial vacuum. When gas molecules
strike the getter material, particular gas molecules (i.e., those
of the selected gas) combine with the getter chemically or by
adsorption. Thus the getter removes the selected gas from the
evacuated space until the active material is exhausted.
[0041] A reactor having a self-regulating oxygen getter powered by
zinc-air battery technology may be used in lieu of the
above-described reactor 16 made up of the reactor substrate 80.
Zinc-air batteries can react to control or reduce the oxygen levels
in sealed site and thus self-regulate a reduced pressure of
approximately 0.8 bars. If the zinc-air battery components are
configured as a working zinc-air battery, the battery voltage will
drop when the oxygen has been depleted and the desired partial
vacuum pressure will have been achieved. This drop in voltage may
be used to indicate that the desired partial vacuum has been
achieved. For example, a 675 size hearing aid zinc-air battery is
rated at 620 mAh, occupies 0.5 mL volume, and weighs 1.9 g. A 675
zinc-air battery can remove more than 150 times its volume of
oxygen.
[0042] The cosmetic pad 18 can be made from a blend of polyester
and cellulose fibers, polypropylene fibers, or other suitable
non-woven polymeric material. The cosmetic liquid or cream can
include at least one of a moisturizer, dimethylaminoethanol (DMAE),
Acetyl hexapeptide-8, Acetyl hexapeptide-3, retinol, ubiquinone,
dithiolane-3-pentanic acid, alpha-hydroxy acid, alpha lipoic acid,
salicylic acid, hydrocortisone, topical botulinum cream, and
hyaluronic acid. The cosmetic pad 18 can include top surface 180
and a bottom surface 182, which is opposite the top surface 180.
The bottom surface 182 can be undulated having hills 184 and
valleys 186, which can allow the cosmetic pad 18 to act as a skin
massaging element. An additional membrane 188 could be provided and
located beneath the cosmetic pad 18 to act as the skin massaging
element. This additional membrane 188 would also be positioned
adjacent to the tissue site 20. This additional membrane 188 could
also include an undulated bottom surface, similar to the bottom
surface 182 having hills 184 and valleys 186. This additional
membrane 188 would also include openings to allow the cosmetic
liquid or cream to pass through the openings to the tissue site 20.
When a partial vacuum is provided in the enclosed volume 22, the
skin can be drawn towards the undulated surface and the skin can
conform to the hills 184 and valleys 186. Accordingly, small
strains and stresses can applied to the patient's skin at the
tissue site 20 providing a massaging effect.
[0043] The controlled pressure device 10 can also include
additional powered components, which is shown as a powered
component 240 that is schematically depicted in FIG. 2. Each
powered component 240, which are described later with reference to
FIGS. 5-7, can be electrically connected with a power source 242
(depicted schematically in FIG. 2) which, for example, can be a
zinc-air battery exposed to ambient or a zinc MnO2 battery,
electrically connected with the powered component 240. When using a
zinc-air battery as the power source 242, the power source 242
would be located outside of the enclosed volume 22 or a section of
the reactor housing element 14 or the skin contacting element 24
could be removable to allow ambient air to contact the zinc-air
battery.
[0044] FIG. 5 depicts a heater 250, which is one example of a
powered component 240 that can be used in the controlled pressure
device 10, electrically connected with the power source 242. The
heater 250 can be a thin film heater or thin film nano wire heater.
The heater 250 can heat the cosmetic liquid or cream impregnated in
the cosmetic pad 18. The heater 250 can be positioned adjacent to
the cosmetic pad 18. A switch 252 can be provided to control power
to the heater 250. The heater 250 can also heat the gas in the
enclosed volume 22, which can heat the tissue site 20.
[0045] FIG. 6 depicts a first electrode 260 and a second electrode
262 electrically connected with the power source 242. The
electrodes are another example of a powered component 240 that can
be used in the controlled pressure device 10. The switch 252 can be
provided to control power to the electrodes 260, 262. The first
electrode 260 can be positioned on a first side of the tissue site
20 and in contact with the skin, and the second electrode 262 can
be positioned on a second, opposite, side of the tissue site 20 and
in contact with the skin. The electrodes 260, 262 can be used to
provide electrical stimulation to the tissue site 20.
[0046] FIG. 7 depicts a light source 280, which is another example
of a powered component 240 that can be used in the controlled
pressure device 10. The light source 280 can include a plurality of
LEDs 282 mounted on a flexible substrate 284. The LEDs 282 are
electrically connected with the power source 242. The flexible
substrate 284 can be placed adjacent to the skin contacting element
24, which can include larger openings 34, which can allow light to
pass for phototherapy.
[0047] FIG. 8 depicts a method of treating tissue using negative
pressure. Although the FIG. 8 shows a specific order of method
steps, the order of the steps may differ from what is depicted.
Also two or more steps may be performed concurrently or with
partial concurrence. The method will be described with reference to
the controlled pressure device 10 depicted in FIGS. 1 and 2,
however, the method can be practiced with other devices.
[0048] At 300, the reactor housing element release layer 120 is
removed from the reactor housing element 14. Removal of the reactor
housing element release layer 120 from the reactor housing element
14 can allow air to contact the reactor 16, which can begin the
reaction in which oxygen (or another selected gas in air) is being
consumed by the reactor 16. At 302, the reactor housing element 14,
the reactor 16 and the liquid impermeable--air permeable membrane
150 are placed over the tissue site 20. At 304, the reactor housing
element 14 is affixed with respect to the skin around the tissue
site 20 to define an at least substantially air-tight enclosed
volume 22 around the tissue site. The reactor 16 can consume the
selected gas (e.g., oxygen) from the enclosed volume 22 thus
reducing the gas pressure in the enclosed volume 22.
[0049] FIG. 9 depicts other steps in a method of treating tissue
using negative pressure. For example, the method may include, at
310, placing a cosmetic liquid or cream on the tissue site 20. The
cosmetic liquid or cream may be placed on the tissue site 20 prior
to placing the reactor housing element 14, the reactor 16 and the
liquid impermeable--air permeable membrane 150 over the tissue site
20, which occurs at step 302.
[0050] The method of treating tissue using negative pressure may
also include, at 312, placing a pad 18 impregnated or wetted with a
cosmetic liquid or cream over the tissue site 20. The pad 18 can be
connected with the reactor housing element 14 in such a manner that
the pad 18 is placed on the tissue site 20 while placing the
reactor housing element 14, the reactor 16 and the liquid
impermeable--air permeable membrane 150 over the tissue site
20.
[0051] The method of treating tissue using negative pressure may
also include, at 314, removing the release layer 40 from the skin
contacting element 24, and, at 316, placing the skin contacting
element 24 over or around the tissue site 20. The skin contacting
element 24 can be placed over or around the tissue site 20 prior to
placing the reactor housing element 14, the reactor 16 and the
liquid impermeable--air permeable membrane 150 over the tissue site
20, which occurs at step 302. As such, affixing the reactor housing
element 14 with respect to skin around the tissue site, which
occurs at step 304, can further include affixing the reactor
housing element 14 to the skin contacting element 24, at 318. The
method may also include affixing the skin contacting element 24 to
the skin around the tissue site 20, at 320.
[0052] It will be appreciated that various of the above-disclosed
controlled pressure device and other features and functions, or
alternatives or varieties thereof, may be desirably combined into
many other different systems or applications. Also that various
presently unforeseen or unanticipated alternatives, modifications,
variations or improvements therein may be subsequently made by
those skilled in the art which are also intended to be encompassed
by the following claims.
* * * * *