U.S. patent application number 16/659814 was filed with the patent office on 2020-02-13 for wound care method and system with one or both of vacuum-light therapy and thermally augmented oxygenation.
This patent application is currently assigned to ThermoTek, Inc.. The applicant listed for this patent is ThermoTek, Inc.. Invention is credited to Tony QUISENBERRY.
Application Number | 20200046569 16/659814 |
Document ID | / |
Family ID | 46966651 |
Filed Date | 2020-02-13 |
View All Diagrams
United States Patent
Application |
20200046569 |
Kind Code |
A1 |
QUISENBERRY; Tony |
February 13, 2020 |
WOUND CARE METHOD AND SYSTEM WITH ONE OR BOTH OF VACUUM-LIGHT
THERAPY AND THERMALLY AUGMENTED OXYGENATION
Abstract
A combination therapy pad that includes a first layer and a
second layer operatively coupled to the first layer. A fiber-optic
array is disposed between the first layer and the second layer. A
third layer is operatively coupled to the first layer. The third
layer includes a vacuum tube in fluid communication with a vacuum
source and a therapeutic fluid tube in fluid communication with a
therapeutic fluid source. The third layer provides at least one of
vacuum therapy and therapeutic fluid treatment to a wound area.
Inventors: |
QUISENBERRY; Tony; (Highland
Village, TX) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ThermoTek, Inc. |
Flower Mound |
TX |
US |
|
|
Assignee: |
ThermoTek, Inc.
Flower Mound
TX
|
Family ID: |
46966651 |
Appl. No.: |
16/659814 |
Filed: |
October 22, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15456147 |
Mar 10, 2017 |
10507140 |
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16659814 |
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14330449 |
Jul 14, 2014 |
9616210 |
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15456147 |
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13962994 |
Aug 9, 2013 |
8940034 |
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14330449 |
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13456410 |
Apr 26, 2012 |
8574278 |
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13962994 |
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13359210 |
Jan 26, 2012 |
8632576 |
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13456410 |
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11975047 |
Oct 17, 2007 |
8128672 |
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13359210 |
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11801662 |
May 9, 2007 |
8100956 |
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11975047 |
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61479156 |
Apr 26, 2011 |
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60852803 |
Oct 19, 2006 |
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60798982 |
May 9, 2006 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 5/0616 20130101;
A61F 7/0085 20130101; A61F 13/00068 20130101; A61N 2005/0661
20130101; A61F 13/00029 20130101; A61F 2007/0295 20130101; A61F
7/02 20130101; A61F 2013/00195 20130101; A61M 1/0023 20130101; A61F
2007/0296 20130101; A61N 2005/0651 20130101; A61N 2005/063
20130101; A61M 37/00 20130101; A61N 2005/0645 20130101; A61F
2013/0017 20130101; A61N 5/0613 20130101; A61N 2005/0652 20130101;
A61M 2205/05 20130101; A61F 2007/0054 20130101; A61N 5/04 20130101;
A61M 2205/051 20130101; A61N 2005/0649 20130101 |
International
Class: |
A61F 13/00 20060101
A61F013/00; A61M 1/00 20060101 A61M001/00; A61N 5/06 20060101
A61N005/06; A61M 37/00 20060101 A61M037/00; A61F 7/00 20060101
A61F007/00; A61N 5/04 20060101 A61N005/04; A61F 7/02 20060101
A61F007/02 |
Claims
1. A method of treating a wound area, the method comprising:
covering the wound area with a therapy pad, the therapy pad
comprising: a first layer; a second layer operatively coupled to
the first layer; a third layer operatively coupled to the first
layer, the third layer having a vacuum tube in fluid communication
with a vacuum source and a therapeutic fluid tube in fluid
communication with a therapeutic fluid source, wherein the third
layer provides at least one of vacuum therapy and therapeutic fluid
treatment to a wound area; and administering at least one of
oxygenation therapy and vacuum therapy to the wound area via the
therapy pad.
2. The method of claim 1, wherein the administering of oxygenation
therapy comprises delivering oxygen from an oxygen source to the
wound area via the therapy pad.
3. The method of claim 2, wherein the administering oxygenation
therapy comprises at least one of warming or cooling the oxygen via
a thermoelectric element.
4. The method of claim 1, comprising administering a pulsed radio
frequency signal to the wound area via a radio frequency antenna
disposed within the therapy pad.
5. The method of claim 4, wherein the radio frequency antenna is
disposed substantially around a perimeter of the wound area.
6. The method of claim 1, wherein the vacuum therapy and the
oxygenation therapy are administered via a common port in the
therapy pad.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This patent application is a continuation of U.S. patent
application Ser. No. 15/456,147, filed on Mar. 10, 2017. U.S.
patent application Ser. No. 15/456,147 is a continuation of U.S.
patent application Ser. No. 14/330,449, filed on Jul. 14, 2014.
U.S. patent application Ser. No. 14/330,449 is a continuation of
U.S. patent application Ser. No. 13/962,994, filed Aug. 9, 2013.
U.S. patent application Ser. No. 13/962,994 is a continuation of
U.S. patent application Ser. No. 13/456,410, filed on Apr. 26, 2012
(now U.S. Pat. No. 8,574,278). U.S. patent application Ser. No.
13/456,410 is a Continuation-in-Part of U.S. patent application
Ser. No. 13/359,210, filed on Jan. 26, 2012 (now U.S. Pat. No.
8,632,576). U.S. patent application Ser. No. 13/359,210 is a
Continuation-in-Part of U.S. patent application Ser. No. 11/975,047
(now U.S. Pat. No. 8,128,672), filed on Oct. 17, 2007. U.S. patent
application Ser. No. 11/975,047 is a Continuation-in-Part of U.S.
patent application Ser. No. 11/801,662 (now U.S. Pat. No.
8,100,956), filed on May 9, 2007. U.S. patent application Ser. No.
11/975,047 claims priority to, and incorporates by reference the
entire disclosure of, U.S. Provisional Patent Application No.
60/852,803, filed on Oct. 19, 2006. U.S. patent application Ser.
No. 11/801,662 (now U.S. Pat. No. 8,100,956) claims priority to,
and incorporates by reference the entire disclosure of, U.S.
Provisional Patent Application No. 60/798,982, filed on May 9,
2006. U.S. patent application Ser. No. 13/456,410 claims priority
to, and incorporates by reference for any purpose, the entire
disclosure of U.S. Provisional Patent Application No. 61/479,156,
filed on Apr. 26, 2011. of U.S. patent application Ser. No.
15/456,147, U.S. patent application Ser. No. 13/456,410, U.S.
patent application Ser. No. 13/359,210, U.S. patent application
Ser. No. 11/975,047, U.S. patent application Ser. No. 11/801,662,
U.S. Provisional Patent Application No. 60/852,803, U.S.
Provisional Patent Application No. 60/798,982, and U.S. Provisional
Patent Application No. 61/479,156 are each incorporated herein by
reference.
[0002] This patent application is related to and incorporates by
reference U.S. Provisional Patent Application No. 60/488,709, filed
on Jul. 18, 2003; U.S. Provisional Patent Application No.
60/550,658 filed on Mar. 5, 2004; and U.S. patent application Ser.
No. 10/894,369, filed on Jul. 19, 2004. This patent application
incorporates by reference commonly assigned U.S. Pat. Nos.
5,097,829; 5,989,285, and 6,935,409.
BACKGROUND OF THE INVENTION
Technical Field
[0003] The present invention relates to a wound care method and
system with one or both of vacuum-light therapy, pulsed radio
frequency ("RF"), and thermally augmented oxygenation, and more
particularly, but not by way of limitation, to a programmable wound
care control unit configured to generate a negative pressure for
wound cleaning with light therapy, and, in one embodiment, pulsed
RF or oxygenation of a wound area for healing in conjunction with
high thermal contrast modalities generated by the control unit.
Description of the Related Art
[0004] An important aspect of patient treatment is wound care.
Medical facilities are constantly in need of advanced technology
for the cleaning and treatment of skin wounds. The larger the skin
wound, the more serious the issues are of wound closure and
infection prevention. The rapidity of the migration over the wound
of epithelial and subcutaneous tissue adjacent the wound is thus
critical. Devices have been developed and/or technically described
which address certain aspects of such wound healing. For example,
U.S. Pat. No. 6,695,823 to Lina et al. ("Lina") describes a wound
therapy device that facilitates wound closure. A vacuum pump is
taught for collecting fluids from the wound. WO 93/09727 discloses
a solution for wound drainage by utilizing negative pressure over
the wound to promote the above references migration of epithelial
and subcutaneous tissue over the wound.
[0005] In other embodiments, wound treatment is performed using
light therapy. For example, U.S. Pat. No. 7,081,128 to Hart et al.
("Hart") describes a method of treating various medical conditions
such as, for example, joint inflammation, edema, etc., utilizing an
array of Light Emitting Diodes contained on a flexible substrate
that may be wrapped around an anatomical feature of the human body.
U.S. Pat. No. 6,596,016 to Vreman et al. ("Vreman") discloses a
phototherapy garment for an infant having a flexible backing
material, a transparent liner, and a flexible printed circuit sheet
containing surface-mounted LEDs. The LEDs preferably emit
high-intensity blue light, suitable for the treatment of neonatal
hyperbilirubinemia. The device may include a portable power
supply.
[0006] In other embodiments, wound treatment is performed using
oxygen. The use of oxygen for the treatment of skin wounds has been
determined to be very beneficial in certain medical instances. The
advantages are multitudinous and include rapidity in healing. For
this reason, systems have been designed for supplying high
concentration of oxygen to wound sites to facilitate the healing
process. For example, U.S. Pat. No. 5,578,022 to Scherson et al.
("Scherson") teaches an oxygen producing bandage and method. One of
the benefits cited in Scherson is the ability to modulate a supply
of concentrated hyperbaric oxygen to skin wounds. Although oxygen
is beneficial in direct application of predetermined dosages to
skin wounds, too much oxygen can be problematic. Oxygen applied to
a wound site can induce the growth of blood vessels for stimulating
the growth of new skin. Too much oxygen, however, can lead to toxic
effects and the cessation of healing of the wound. It would be an
advantage, therefore, to maximize the effectiveness of oxygen
applied to a wound area by enhancing the absorption rate of oxygen
into the skin and tissue fluids. By enhancing the absorption rate
of the oxygen in the wound, less exposure time and concomitantly
fewer toxic side effects to the endothelial cells surrounding the
wound, such as devasculation, occurs. It would be a further
advantage, therefore, to utilize existing medical treatment
modalities directed toward other aspects of patient therapy to
augment oxygenation for wound care.
[0007] It has been accepted for many years by medical care
providers that patient thermal therapy can be very advantageous for
certain injuries and/or post operative recovery. For this reason,
thermal therapy has been advanced and many reliable and efficient
systems exist today which provide localized thermal therapy to
patients in both pre and post surgical environments. In particular,
absorption of oxygen by cells is enhanced by contrast thermal
therapy wherein the wound area is heated prior to being saturated
with oxygen and subsequently cooled.
[0008] Addressing first thermal therapy systems, several devices
have been engineered to deliver temperature controlled fluids
through pads or convective thermal blankets to achieve the above
purpose. Typically, these devices have a heating or a cooling
element, a source for the fluid, a pump for forcing the fluid
through the pad or blanket, and a thermal interface between the
patient and the temperature controlled fluid. U.S. Pat. No.
4,884,304 to Elkins ("Elkins") is, for example, directed to a
mattress cover device which contains liquid flow channels which
provide the selective heating or cooling by conduction.
[0009] Devices have also been developed for simply providing heat
or cooling to a person in bed. Electric blankets containing
electric heating elements have been used, for example, to provide
heat to people in bed. Likewise, cooling blankets, such as the
blanket disclosed in U.S. Pat. No. 4,660,388 to Greene ("Greene"),
have also been proposed. Greene discloses a cooling cover having an
inflatable pad with plenum chambers at opposite ends thereof. Cool
air is generated in a separate unit and directed to the pad and out
to a number of apertures on the underside of the pad and against
the body of the person using the cover.
[0010] A disposable heating or cooling blanket is disclosed in U.S.
Pat. No. 5,125,238 to Ragan et al. ("Ragan"), which has three
layers of flexible sheeting. Two of the layers form an air chamber
while a third layer includes a comfortable layer for contact with
the patient. Conditioned air is directed toward the covered person
through a multiplicity of orifices in the bottom layers of the
blanket.
[0011] A temperature controlled blanket and bedding assembly is
also disclosed in U.S. Pat. No. 5,989,285 to DeVilbiss et al.
("DeVilbiss"), assigned to the assignee of the present invention.
DeVilbiss discloses a temperature controlled blanket and
temperature control bedding system having the provision of both
recirculating temperature controlled fluid and temperature
controlled gas to enhance performance for convectively heating or
cooling a patient. Counter-flow or co-flow heat exchanging
principles between the temperature controlled liquid and the
temperature controlled gas achieve temperature uniformity across
different sections of the blanket and the bedding system. Drapes
and the temperature controlled bedding system provide a temperature
controlled envelope around a person using the bedding system. In
one embodiment of the bedding system, the air portion of the
bedding system is provided for use with a patient that supplies the
fluid portion of the overall bedding system. In another embodiment
of the bedding system, the fluid portion of the bedding system is
provided for use with a patient bed which supplies the air portion
of the overall bedding system.
[0012] U.S. Pat. No. 5,097,829 to Quisenberry ("Quisenberry")
describes an improved temperature controlled fluid circulating
system for automatically cooling a temperature controlled fluid in
a thermal blanket with a thermoelectric cooling device having a
cold side and a hot side when powered by electricity. The
temperature controlled fluid is cooled by the cold side of the
cooling device and pumped through, to, and from the blanket through
first and second conduits.
[0013] Finally, co-pending U.S. patent application Ser. No.
10/894,369, assigned to the assignee of the present invention,
teaches a sequential compression blanket for use with heating or
cooling therapy. In this particular embodiment, the utilization of
thermal therapy with sequential compression in a programmable
format which further has the option of the introduction of
oxygenation through a perforated membrane disposed between the
patient and the thermal therapy pad is taught. These advances in
the medical industry have been recognized as advantageous to both
the medical care providers as well as the patients. The precise
manner of oxygenation application is, however, still in the process
of development.
[0014] The present invention provides improvements in wound care by
providing multiple wound healing approaches such as, for example,
the application of negative pressure over the wound area along with
light therapy of the wound area, and oxygenation of the wound area
in conjunction with thermal therapy. By combining an oxygenation
modality that is utilized in conjunction with light and thermal
therapy and/or sequential compression in association therewith, the
individual benefits of negative wound pressure, light therapy, and
oxygenation treatments can be synergistically enhanced.
SUMMARY
[0015] In one aspect, the present invention relates to a therapy
system. The therapy system includes a therapy pad having a
plurality of fiber-optic strands and a port. A pressure switch is
fluidly coupled to the port. An oxygen source is fluidly coupled to
the pressure switch. A vacuum pump is fluidly coupled to the
pressure switch. A plurality of light emitting diodes is
operationally coupled to the plurality of fiber-optic strands. The
pressure switch adjusts the therapy pad between vacuum and
oxygenation therapy.
[0016] In another aspect, the present invention relates to a
therapy pad. The therapy pad includes an outer surface and an inner
surface. A bladder is disposed between the outer surface and the
inner surface. An array of fiber optic strands is disposed on the
inner surface. An inlet is disposed on the outer surface. The inlet
is fluidly coupled to a plurality of ports disposed on the inner
surface. A radio frequency antenna is disposed on the inner
surface.
[0017] In another aspect, the present invention relates to a method
of treating a wound area. The method includes dressing the wound
area with a therapy pad and administering at least one of
ultra-violet light and vacuum therapy to the wound area via the
therapy pad. In various embodiments, the method may also include
administering oxygenation therapy to a wound area via the therapy
pad, administering thermal therapy to the wound area via the
therapy pad, and administering a pulsed radio frequency signal to
the wound area via a radio frequency antenna disposed within the
therapy pad.
[0018] A combination therapy pad that includes a first layer and a
second layer operatively coupled to the first layer. A fiber-optic
array is disposed between the first layer and the second layer. A
third layer is operatively coupled to the first layer. The third
layer includes a vacuum tube in fluid communication with a vacuum
source and a therapeutic fluid tube in fluid communication with a
therapeutic fluid source. The third layer provides at least one of
vacuum therapy and therapeutic fluid treatment to a wound area.
[0019] A therapy system that includes a combination therapy pad
having a plurality of fiber-optic strands and a port. A pressure
switch is fluidly coupled to the port. An oxygen source and a
vacuum pump are fluidly coupled to the pressure switch. A plurality
of light emitting diodes are optically coupled to the plurality of
fiber-optic strands. A thermoelectric element is thermally exposed
to the oxygen source. The combination therapy pad administers at
least one of vacuum therapy and oxygenation therapy via the
pressure switch.
[0020] A method of treating a wound area. The method includes
covering the wound area with a therapy pad, the therapy pad having
a first layer, a second layer operatively coupled to the first
layer, a fiber-optic array disposed between the first layer and the
second layer, and a third layer operatively coupled to the first
layer. The third layer includes a vacuum tube in fluid
communication with a vacuum source and a therapeutic fluid tube in
fluid communication with a therapeutic fluid source. The third
layer provides at least one of vacuum therapy and therapeutic fluid
treatment to a wound area. The method further includes
administering at least one of ultra-violet light therapy and vacuum
therapy to the wound area via the therapy pad and administering at
least one of oxygenation therapy and thermal therapy to the wound
area via the therapy pad.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] A more complete understanding of the method and apparatus of
the present invention may be obtained by reference to the following
Detailed Description when taken in conjunction with the
accompanying Drawings wherein:
[0022] FIG. 1 is an illustration of the wound care system according
to an exemplary embodiment;
[0023] FIG. 2 is a block diagram according to an exemplary
embodiment;
[0024] FIG. 3 is a flow diagram of a process according to an
exemplary embodiment;
[0025] FIG. 4 illustrates a side elevational cross sectional view
of a therapy blanket/pad according to an exemplary embodiment;
[0026] FIG. 5 illustrates a side elevational cross sectional view
of a therapy blanket/pad according to an exemplary embodiment;
[0027] FIG. 6 is a diagrammatic illustration of a therapy
blanket/pad according to an exemplary embodiment;
[0028] FIG. 7 is a diagrammatic illustration of a wound evacuation
and UV LED treatment pad according to an exemplary embodiment;
[0029] FIG. 8A is a schematic diagram of a wound care system
according to an exemplary embodiment;
[0030] FIG. 8B is a front perspective view of a wound care system
according to an exemplary embodiment;
[0031] FIG. 8C is a front perspective view of a wound care system
illustrating a plurality of hooks according to an exemplary
embodiment;
[0032] FIG. 9 is a is a block diagram of a wound care system
according to an exemplary embodiment;
[0033] FIG. 10 is a block diagram of a wound care system according
to an exemplary embodiment;
[0034] FIG. 11 is a diagrammatic illustration of a combination
therapy pad according to an exemplary embodiment;
[0035] FIG. 12 is a diagrammatic illustration of a combination
therapy pad according to an exemplary embodiment; and
[0036] FIG. 13 is an exploded view of a combination therapy pad
according to an exemplary embodiment.
DETAILED DESCRIPTION
[0037] Various embodiments of the present invention will now be
described more fully with reference to the accompanying drawings.
The invention may, however, be embodied in many different forms and
should not be construed as limited to the embodiments set forth
herein; rather, the embodiments are provided so that this
disclosure will be thorough and complete, and will fully convey the
scope of the invention to those skilled in the art.
[0038] Referring first to FIG. 1, there is shown an illustration of
one embodiment of a wound care system 10 in accordance with
principles of the present invention. The system 10 comprises a
control unit 12, a therapy blanket/pad 14 and a plurality of
tubular members 16 (to be defined below) connecting the control
unit 12 to the therapy blanket/pad 14. The system 10 further
includes a wound evacuation and ultra violet light emitting diode
(UV LED) unit 28 and a wound evacuation and UV LED treatment pad
58. The wound evacuation and UV LED unit 28 is connected to the
control unit 12 while the wound evacuation and UV LED treatment pad
58 is connected to the wound evacuation and UV LED unit 28. A
system for providing both oxygenation therapy in conjunction with
certain aspects of thermal therapy and fully describing the thermal
operation and sequence compression aspects of one embodiment of the
present invention is set forth and shown in U.S. patent application
Ser. No. 10/894,369, assigned to the assignee of the present
invention and incorporated herein in its entirety by reference. For
that reason, thermal detail relative to the interaction between the
control unit 12 and the therapy blanket/pad 14 relative to the
thermal fluid flow and pressurization for sequenced compression
therapy is not further defined herein. What is defined, is the
added aspect of wound care provided by wound evacuation and light
therapy. Light therapy is the application of light energy to the
skin for therapeutic benefits. LED light therapy promotes wound
healing and human tissue growth. Energy delivered by the LEDs
enhances cellular metabolism, accelerates the repair and
replenishment of damaged skin cells, as well as stimulates the
production of collagen which is the foundation of a healthy and
smooth skin. Light therapy is non-ablative, non-invasive, and
painless.
[0039] Still referring to FIG. 1, the use of the therapy
blanket/pad 14 to the wound site of the patient may be, in one
embodiment, subsequent to the cleaning of the wound area of dead
tissue by the wound evacuation and UV LED treatment pad 58. In one
embodiment, Velcro cross straps may be utilized to secure the
therapy blanket/pad 14. A 93% concentration of oxygen has been
suggested to be advantageous when applied to a wound site as
described herein with one or two atmospheres of pressure. In
accordance with one aspect of the present invention, an oxygen
generator/concentrator 20 may be utilized within the control unit
12 or may be separate therefrom. In FIG. 1, an oxygen
generator/concentrator 20 is shown in association with the control
unit 12 by dotted line 22 and an oxygenation gas line 24 shown
extending between the control unit 12 and the therapy blanket/pad
14 as a diagrammatic illustration according to an embodiment of the
present invention.
[0040] In FIG. 1, fiber optic strands (not explicitly shown) direct
ultraviolet light from a plurality of LEDs (not explicitly shown)
to an array of fiber optic strand ends (not explicitly shown)
located on the undersurface of wound evacuation and UV LED
treatment pad 58. The control unit 12 may be used to modulate the
ultraviolet light to create various patterns of light, different
intensities of light, and different durations of light. For
example, the control unit 12 may be used to generate pulsed
emission of ultraviolet light. The ultraviolet light is capable of
penetrating through several layers of skin to destroy infectious
bacteria. In one embodiment, not specifically shown herein, the UV
LED treatment pad 58 may be provided on the therapy blanket/pad 14.
According to exemplary embodiments, the ultraviolet light from the
plurality of LEDs located on the undersurface of wound evacuation
and UV LED treatment pad 58 destroys a wide variety of
microorganisms such as, for example, bacteria which causes skin
infections. In addition, the ultraviolet light from the plurality
of LEDs improves wound healing along with cell and bone growth.
Furthermore, the use of LEDs in light therapy is safe,
non-invasive, drug-free and therapeutic.
[0041] Referring now to FIG. 2, there is a block diagram 200
illustrating the flow of oxygenation gas as a transfer fluid
according to an embodiment of the present invention. As set forth
in the block diagram 200, a control unit display 30 is provided in
conjunction with an analog/digital processing unit 32. A plurality
of sensors 34 are utilized in conjunction with the processing unit
32 for control of heat transfer fluids to the therapy blanket/pad
14 as well as the oxygen delivery thereto. The oxygen
generator/concentrator 20 is connected to a power supply 36, which
power supply 36, also powers the processing unit 32. The oxygen
generated from the oxygen generator/concentrator 20 is then pumped
through compression pump 38 before delivery to the therapy
blanket/pad 14. It should be noted that an oxygen supply may also
be used.
[0042] Referring still to FIG. 2, a water/alcohol reservoir 40 is
shown in fluid flow communication with fluid pump 42 and Thermo
Electric Cooler (TEC) heater/cooler 44. The TEC heater/cooler 44 is
controlled by the processing unit 32 and a TEC supply 46 is
likewise shown. Adjacent the TEC supply 46 is illustrated a
diagrammatical schematic of a treatment chamber 50 defined beneath
the therapy blanket/pad 14 wherein the treatment chamber 50 is
thermally exposed to the thermal fluid by the fluid path therein
illustrated. The adhesive attachment edges 52 therein shown
likewise define the treatment chamber space 50 between the therapy
blanket/pad 14 and the wound site to allow for the flow of the
oxygenation gas therein.
[0043] Referring still to FIG. 2, there is shown a vacuum pump 59
powered by the power supply 36. A collection chamber 56 is
connected to the vacuum pump 59 and to a wound evacuation and UV
LED treatment pad 58. The wound evacuation and UV LED treatment pad
58 is used prior to the therapy blanket/pad 14, in one embodiment
of the present invention, for cleaning the wound area in
preparation for oxygenation in conjunction with thermal therapy in
accordance with the present invention.
[0044] Referring still to FIG. 2, there is shown a plurality of
ultraviolet LEDs 60 and fiber optic strands 62, which are
interoperably connected to the wound evacuation and UV LED
treatment pad 58. The wound evacuation and UV LED treatment pad 58
is used prior to the therapy blanket/pad 14, in one embodiment of
the present invention, for removing bacteria from the wound area in
preparation for oxygenation in conjunction with thermal therapy in
accordance with an embodiment. According to exemplary embodiments,
ultraviolet light from the plurality of LEDs 60 destroys a wide
variety of microorganisms such as, for example, bacteria which
causes skin infections. In addition, the ultraviolet light from the
plurality of LEDs 60 improves wound healing along with cell and
bone growth. Furthermore, the use of the plurality of LEDs 60 in
light therapy is safe, non-invasive, drug-free and therapeutic.
[0045] According to exemplary embodiments, the ultraviolet light
from the plurality of LEDs 60 is in the range of approximately 200
to 450 nanometers and higher, and energy levels of up to 35,000
microwatt seconds/cm.sup.2, which are necessary to eliminate or
destroy most microorganisms such as bacteria, spores, algae and
viruses. Most bacteria can be destroyed at ultra violet energies of
from about 3,000 to about 5,000 microwatt-seconds/cm.sup.2 while
mold spores may require energies in the 20,000 to 35,000
mW-seconds/cm.sup.2.
[0046] Referring now to FIG. 3 there is shown a flow diagram of a
process 300 according to an embodiment. The process 300 starts at
step 101. At step 102, the wound area is cleaned of dead tissue,
any undesirable fluids, and bacteria by applying the wound
evacuation and UV LED treatment pad 58. The wound evacuation and UV
LED treatment pad 58 is used prior to the therapy blanket/pad 14
for removing bacteria from the wound area in preparation for
oxygenation in conjunction with thermal therapy in accordance with
the present invention. According to exemplary embodiments, the
ultraviolet light from the plurality of LEDs located on the
undersurface of wound evacuation and UV LED treatment pad 58
destroys a wide variety of microorganisms such as, for example,
bacteria which causes skin infections. In addition, the ultraviolet
light from the plurality of LEDs improves wound healing along with
cell and bone growth. Furthermore, the use of LEDs in light therapy
is safe, non-invasive, drug-free and therapeutic.
[0047] At step 103, the therapy blanket/pad 14 is applied to the
wound area. The therapy blanket/pad 14 is held in position by an
adhesive border and, in one embodiment, elastic Velcro cross
straps. At step 104, according to an embodiment, an oxygenation gas
comprising on the order of 93% concentration of oxygen gas is
delivered to the wound site with one to two atmospheric pressures.
The numbers as set forth and shown are exemplary and other
oxygenation concentrations as well as pressures are contemplated in
various embodiments. Consistent therewith, however, is the concept
of, and teachings for, thermal treatment of the wound site in
conjunction with oxygenation. In step 106, the site is warmed
through the fluid path herein shown on the back side of the therapy
blanket/pad 14 up to approximately 5 to approximately 6 degrees
above the body temperature of the patient. Warming allows the pores
of the patient's skin to open, exposing capillaries therein. The
capillaries of the skin are then saturated with oxygen. In one
period of time herein described, a warming period of approximately
15 to approximately 30 minutes is recommended. At step 108,
oxygenation is continued at one to two atmospheres and the therapy
blanket/pad fluid is lowered to approximately 30 to approximately
40 degrees below body temperatures. Cooling closes the pores of the
wound area and pulls oxygen into the underlying tissue. Cooling
then proceeds for approximately 30 to approximately 45 minutes in
accordance with an embodiment. At step 110, the process 300 may be
repeated periodically and the wound area may be cleaned of dead
tissue before each treatment. At step 112, the process 300
ends.
[0048] FIG. 4 is a side elevational, cross sectional view of one
embodiment of the therapy blanket/pad 14. In an embodiment, the
therapy blanket/pad 14 is constructed with a single bladder 114
where thermal fluid flow may be provided. The tubular members 16
are coupled to the therapy blanket/pad 14. The therapy blanket/pad
is fabricated with a circuitous flow path therein for thermal fluid
flow. The circuitous flow path may be tubular in form, or simply a
path within therapy blanket/pad 14 defined by flow channels. What
is shown is a path 117 within therapy blanket/pad 14. The path 117
is shown with tubular ends 117A, for example, illustrating that
thermal fluid flows therein for thermal treatment of the underlying
wound area. Again, the path 117 may not be of tubular form and may
have a variety of shapes and fabrication techniques well know in
the art of thermal pads.
[0049] According to an exemplary embodiment, the therapy
blanket/pad 14 is separated from the patient's skin by adhesive
strips 119 having a thickness of, for example, 1/8 inch. The
therapy blanket/pad 14 (not drawn to scale) exposes the wound to
both heat and cold via the path 117 while oxygen is injected into
the treatment chamber 50. The injection of oxygen in conjunction
with the aforesaid heating and cooling via the path 117 helps treat
the wound area and any stasis zones therein where tissue swelling
has restricted flow of blood to tissues within the wound area. It
is well known that, without sufficient blood flow, the epithelial
and subcutaneous tissues referenced above receive less oxygen and
are less able to migrate over the wound area to promote healing. By
utilizing the embodiments disclosed herein, oxygenation is enhanced
and the problems associated with such conditions are mitigated.
[0050] FIG. 5 illustrates an exemplary embodiment of the thermal
therapy and oxygenation treatment pad of FIG. 4. A dual bladder 214
is thus provided where air may be applied to second bladder 207
atop the path 117, also represented by the "tubular" ends 117A
shown for purposes of example only. In this manner, select
compression therapy may be afforded in conjunction with the thermal
and oxygenation treatment. In that regard, air inlet tube 201 is
connected to the second bladder 207. Both FIGS. 4 and 5 show oxygen
tube 24 for feeding oxygen to the treatment chamber 50, with tube
203 allowing thermal fluid into conduits 117 with tube 205 allowing
thermal fluid return to control unit 12 of FIG. 1. FIG. 5 further
illustrates the advantages of FIG. 4 with the ability for either
compression or sequenced compression as referenced above.
[0051] Referring now to FIG. 6, there is shown a diagrammatic
illustration of the therapy blanket/pad 14 of FIGS. 1 and 4. The
tubular members 16 for thermal fluid flow and the tube 24 for
oxygen flow are clearly seen. The adhesive border 119 is likewise
shown.
[0052] FIG. 7 is diagrammatic illustration of a wound evacuation
and UV LED treatment pad 58 according to an embodiment of the
present invention. In this embodiment, the wound evacuation and UV
LED treatment pad 58 contains an array of fiber optic strand 72 to
project ultraviolet light onto a wound area (not explicitly shown).
In a typical embodiment, the fiber optic strands 72 may be cleaved
side emitting fibers. The wound evacuation and UV LED treatment pad
58 also contains an array of unique removal ports 57 that may be
used to remove any undesirable fluid from the wound area. The wound
evacuation and UV LED treatment pad 58 further contains a
non-tissue adhesive service 80 which contains both the fiber optic
strand array 72 and the unique removal ports 57. An adhesive
circumference 82 is located around the periphery of the wound
evacuation and UV LED treatment pad 58 to allow for a seal to be
formed around the wound area. The seal, in conjunction with the
removal ports 57, allows a negative pressure to form over the wound
area. Negative pressure facilitates removal undesirable tissues
from the wound area. The wound evacuation and UV LED treatment pad
58 is connected to a control unit 12. The control unit 12 contains
a vacuum pump (not shown) and a plurality of ultraviolet LEDs (not
explicitly shown). The vacuum pump is connected to the wound
evacuation and UV LED treatment pad 58 via a vacuum line 55. A
collection chamber 56 is positioned between the vacuum pump and the
wound evacuation and UV LED treatment pad 58 to intercept and store
undesirable fluids, tissues, and the like that are removed from the
wound area as a result of negative pressure applied to the wound
area with the vacuum pump. The plurality of ultraviolet LEDs
transmit ultraviolet light through the fiber optic strands 70 to
the wound evacuation and UV LED treatment pad 58, where the fiber
optic strands 70 are then dispersed throughout the wound evacuation
and UV LED treatment pad 58 to project ultraviolet light onto the
wound area. Energy delivered by the plurality of LEDs enhances
cellular metabolism, accelerates repair and replenishment of
damaged skin cells, as well as stimulates production of collagen
which is the foundation of a healthy and smooth skin. Light therapy
is non-ablative, non-invasive, and painless.
[0053] FIG. 8A is a schematic diagram of a wound care system
according to an exemplary embodiment. A wound care system 800
includes a control unit 802, a combination therapy pad 804, and a
plurality of tubular members 806 connecting the combination therapy
pad 804 to the control unit 802. A wound evacuation and UV-LED unit
808 is associated with the control unit 802 and connected to the
combination therapy pad 804. In various embodiments, the wound
evacuation and UV-LED unit 808 and the control unit 802 are
contained in a single housing; however, in various alternative
embodiments, the wound evacuation and UV-LED unit 808 and the
control unit 802 may not be in a single housing and are independent
devices.
[0054] Still referring to FIG. 8A, use of the combination therapy
pad 804 incorporates ultraviolet light and evacuation therapy for
wound cleaning with thermal and oxygenation therapy known to
promote healing. In various embodiments, Velcro cross straps are
used to secure the combination therapy pad 804. An oxygen
generator/concentrator 810 is utilized to provide, for example, a
93% concentration of oxygen to a wound site via the combination
therapy pad 804. In a typical embodiment, the oxygen
generator/concentrator 810 and the control unit 802 are separate
devices; however, in other embodiments, the oxygen
generator/concentrator 810 and the control unit 802 are contained
in a single housing.
[0055] Still referring to FIG. 8A, fiber optic strands (not
explicitly shown) direct ultraviolet light from a plurality of LEDs
(not explicitly shown) located in the wound evacuation and UV-LED
unit 808 to an array of fiber optic strands (not explicitly shown)
located on an undersurface of the combination therapy pad 804. The
control unit 802 may be used to modulate the ultraviolet light to
create, for example, various patterns of light, different
intensities of light, and different durations of light. For
example, in various embodiments, the control unit 802 is used to
produce pulsed emission of the ultraviolet light.
[0056] FIG. 8B is a front perspective view of a wound care system
according to an exemplary embodiment. The wound care system 800
includes the control unit 802, the combination therapy pad 804, and
the plurality of tubular members 806 connecting the combination
therapy pad 804 to the control unit 802. A user interface 805 is
disposed on a front surface of the control unit 802. In a typical
embodiment, the user interface 805 allows a user to control various
parameters of wound care-treatment including, for example, oxygen
concentration, oxygen pressure, temperature, and ultra-violet light
intensity. The user interface 805 may be pivoted relative to the
control unit 802 to provide a favorable viewing angle. In a typical
embodiment, the user interface 805 may be, for example a touch
screen interface; however, in other embodiments, the user interface
805 may be, for example, a plurality of controls or any other user
interface. Use of the combination therapy pad 804 incorporates
ultraviolet light and evacuation therapies for wound cleaning with
thermal and oxygenation therapy known to promote healing. In
various embodiments, Velcro cross straps (not shown) may be used to
secure the combination therapy pad 804.
[0057] FIG. 8C is a front perspective view of the wound care system
of FIG. 8A illustrating a plurality of foldable hooks. The wound
care system 800 includes a plurality of foldable hooks 803
disposed, for example, along a top of the control unit 802. In a
typical embodiment, the plurality of foldable hooks 803 may be
utilized to hang the control unit 802 from, for example, a hospital
bed.
[0058] FIG. 9 is a block diagram of a wound care system according
to an exemplary embodiment. In a wound-care system 900, a control
unit display 902 is provided in conjunction with a processing unit
904. In a typical embodiment, the processing unit 904 is an
analog/digital processing unit. A plurality of sensors 906 are
utilized in conjunction with the processing unit 904 for control of
heat transfer fluids to a combination therapy pad 804. In various
embodiments, the oxygen generator/concentrator 810 is connected to
a power supply 908. The power supply 908 also powers the processing
unit 904. Oxygen generated by the oxygen generator/concentrator 810
is pumped through a compression pump 910 and a pressure switch 921
before being delivered to the combination therapy pad 804.
[0059] Still referring to FIG. 9, in a typical embodiment, a
water/alcohol reservoir 912 is in fluid communication with a fluid
pump 914 and a thermoelectric cooler 916. The thermoelectric cooler
916 is controlled by the processing unit 904. In a typical
embodiment, a vacuum pump 918 is powered by the power supply 908. A
collection chamber 920 is fluidly connected to the vacuum pump 918
and the pressure switch 921. The pressure switch 921 is fluidly
coupled to the combination therapy pad 804. In a typical
embodiment, oxygen therapy and vacuum therapy are each administered
to the combination therapy pad 804 through a common port 922. In a
typical embodiment, the pressure switch 921 is capable of adjusting
the combination therapy pad 804 between vacuum treatment and
oxygenation therapy.
[0060] FIG. 10 is a block diagram of a wound care system according
to an exemplary embodiment. In a typical embodiment, a wound care
system 1000 is similar in construction to the arrangement described
above with respect to FIG. 9. However, the wound care system 1000
does not include a water/alcohol reservoir or a fluid pump as shown
in FIG. 9. In a typical embodiment, the thermoelectric cooler 916
is in fluid communication with the compression pump 910. Thus,
thermal therapy is supplied to the combination therapy pad 804
through heating and cooling of the oxygen supplied by the oxygen
generator/concentrator 810.
[0061] FIG. 11 is a diagrammatic illustration of a combination
therapy pad according to an exemplary embodiment. In a typical
embodiment, the combination therapy pad 804 includes a plurality of
fiber optic strands 72 to project ultraviolet light onto a wound
area (not explicitly shown). In various embodiments, the fiber
optic strands 72 may be cleaved or side-emitting fibers; however,
one skilled in the art will recognize that any type of fiber-optic
strand could be used. In a typical embodiment, the combination
therapy pad 804 also includes a plurality of oxygenation/removal
ports 1102. In a typical embodiment, the oxygenation/removal ports
1102 alternate between providing oxygen therapy and vacuum therapy
to the wound area.
[0062] Still referring to FIG. 11, in a typical embodiment, oxygen
therapy and vacuum therapy is administered to the combination
therapy pad 804 via an evacuation/oxygenation line 1104. The
evacuation/oxygenation line 1104 is fluidly coupled to the pressure
switch 921. The pressure switch 921 is fluidly connected to the
compression pump 910 and the vacuum pump 918. Thus, in a typical
embodiment, the pressure switch 921 is capable of adjusting the
combination therapy pad 804 between vacuum treatment and
oxygenation therapy.
[0063] Still referring to FIG. 11, in various embodiments, a luer
lock 1106 is fluidly coupled to the combination therapy pad 804.
During treatment, it is often necessary to administer various
medications to a wound site. Such administration often requires
removal of a wound dressing such as, for example, the combination
therapy pad 804. Frequent removal of the wound dressing can
increase risk of further damage to tissue immediately surrounding
the wound site. In a typical embodiment, the luer lock 1106 allows
for administration of medications and other therapeutic compounds
directly to a wound site without the need to remove the combination
therapy pad 804.
[0064] FIG. 12 is a diagrammatic illustration of a combination
therapy pad according to an exemplary embodiment. In a typical
embodiment, the combination therapy pad 1200 includes the plurality
of fiber optic strands 72 to project ultraviolet light onto a wound
area (not explicitly shown). In a typical embodiment, a combination
therapy pad 1200 also includes a radio frequency ("RF") antenna
1202. In a typical embodiment, the RF antenna 1202 comprises a wire
1204. The wire 1204 extends along a length of the combination
therapy pad 1204. In a typical embodiment, the wire 1204 is
disposed within the combination therapy pad 1200 so that, during
use, the wire is in close proximity to a wound area. In various
embodiments, the wire 1204 is insulated to reduce risk of electric
shock to a patient.
[0065] FIG. 13 is an exploded view of a combination therapy pad
according to an exemplary embodiment. A combination therapy pad
1300 includes a first layer 1302 having a first central gap 1304
formed therein. In a typical embodiment, the first layer 1302 is
constructed of, for example, urethane. A second layer 1305 is
disposed below the first layer 1302 and includes an adhesive bottom
surface 1306. A second central gap (not explicitly shown) is formed
in the second layer 1305 In a typical embodiment, the second layer
1305 is constructed of, for example, urethane. The first layer 1302
and the second layer 1305 are coupled to each other around a
perimeter of the first layer 1302 and the second layer 1305 so that
the second central gap aligns with the first central gap 1304. A
fiber-optic array 1308 is disposed between the first layer 1302 and
the second layer 1305 so as to fill a space defined by the first
central gap 1304 and the second central gap.
[0066] Still referring to FIG. 13, a third layer 1310 is disposed
above the first layer 1302. The third layer 1310 includes a
recessed central area 1312. The recessed central area 1312 is
fluidly coupled to a vacuum tube 1314 via a first port and a
therapeutic fluid tube 1316 via a second port. An antenna 1318 is
coupled to the third layer 1310. The antenna 1318 is formed into a
loop and is generally arranged around a perimeter of the recessed
central area 1312. In a typical embodiment, the first layer 1302,
the second layer 1305, and the third layer 1310 are coupled to each
other via a process such as, for example, adhesive bonding or
welding.
[0067] Still referring to FIG. 13, during operation, the adhesive
bottom surface 1306 is placed on a bodily region of a patient
proximate a wound area. In a typical embodiment, the adhesive
bottom surface 1306 is oriented such that the second central gap is
positioned over the wound area. Thus, the adhesive bottom surface
1306 is not in direct contact with the wound area. The fiber-optic
array 1308 is disposed over the wound area and, in various
embodiments, may contact the wound area. The fiber-optic array 1308
delivers UV lighting to the wound area thereby promoting cleaning
and disinfection of the wound area. The vacuum tube 1314 applies
negative pressure to the wound area thereby removing undesirable
fluids, tissues, and the like from the wound area. The therapeutic
fluid tube 1316 provides a therapeutic fluid such as, for example,
oxygen to the wound area. In various embodiments, the therapeutic
fluid may be heated or cooled prior to delivery to the wound area.
Heating or cooling of the therapeutic fluid allows delivery of
thermal therapy to the wound area.
[0068] Still referring to FIG. 13, during operation, a pulsed
radio-frequency ("RF") signal having a pulse frequency on the order
of, for example 27 MHz, is transmitted to the antenna 1318. In a
typical embodiment, an amplitude of the pulsed RF signal is on the
order of, for example, a fraction of a Watt. Such an amplitude is
below a threshold where federal licensing is typically required.
The antenna 1318 receives the pulsed RF signal from a
radio-frequency source and transmits the pulsed RF signal to a
region in close proximity to the wound area. Exposing the wound
area to the pulsed RF signal has been shown to be beneficial to
healing by encouraging intracellular communication. In particular,
pulsed RF signals have been shown to stimulate cellular bonding,
and metabolism.
[0069] The previous Detailed Description is of embodiment(s) of the
invention. The scope of the invention should not necessarily be
limited by this Description. The scope of the invention is instead
defined by the following claims and the equivalents thereof.
* * * * *