U.S. patent application number 16/353505 was filed with the patent office on 2019-07-11 for method and system for wound care.
The applicant listed for this patent is ThermoTek, Inc.. Invention is credited to Tony QUISENBERRY, Todd Davis TABER.
Application Number | 20190209859 16/353505 |
Document ID | / |
Family ID | 53042190 |
Filed Date | 2019-07-11 |
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United States Patent
Application |
20190209859 |
Kind Code |
A1 |
QUISENBERRY; Tony ; et
al. |
July 11, 2019 |
METHOD AND SYSTEM FOR WOUND CARE
Abstract
In one aspect, the present invention relates to a wound-care
assembly The wound-care assembly includes a base layer. A film
layer is operatively coupled to the base layer and a fluid
conductor is in fluid communication with a wound and a vacuum
source. The wound-care assembly further includes a fiber-optic
patch comprising a plurality of fiber-optic strands. The
fiber-optic strands are pressed into contact with an interior
surface of the wound by the fluid conductor. The fiber-optic patch
provides ultraviolet light to the wound and the relative vacuum is
applied to the wound via the vacuum source and the fluid
conductor.
Inventors: |
QUISENBERRY; Tony; (Highland
Village, TX) ; TABER; Todd Davis; (Keller,
TX) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ThermoTek, Inc. |
Flower Mound |
TX |
US |
|
|
Family ID: |
53042190 |
Appl. No.: |
16/353505 |
Filed: |
March 14, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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15596743 |
May 16, 2017 |
10272258 |
|
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16353505 |
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14537255 |
Nov 10, 2014 |
9669233 |
|
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15596743 |
|
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61902455 |
Nov 11, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61N 2005/0662 20130101;
A61N 2005/0645 20130101; A61N 5/0616 20130101; A61M 1/0088
20130101; A61M 2205/36 20130101; A61M 2205/368 20130101; A61M
2205/053 20130101; A61M 1/0084 20130101; A61M 1/0039 20130101; A61M
2202/0208 20130101; A61M 2205/05 20130101; A61N 2005/0661 20130101;
A61N 2005/063 20130101; A61M 35/00 20130101 |
International
Class: |
A61N 5/06 20060101
A61N005/06; A61M 35/00 20060101 A61M035/00; A61M 1/00 20060101
A61M001/00 |
Claims
1. A wound-care assembly comprising: a base layer; a film layer
operatively coupled to the base layer; a fluid conductor in fluid
communication with a wound and a vacuum source; a fiber-optic patch
comprising a plurality of fiber-optic strands, the fiber-optic
strands being pressed into contact with an interior surface of the
wound by the fluid conductor; wherein the fiber-optic patch
provides ultraviolet light to the wound; and wherein a relative
vacuum is applied to the wound via the vacuum source and the fluid
conductor.
2. The wound-care assembly of claim 1, comprising a fluid port
fluidly coupled to the fluid conductor.
3. The wound-care assembly of claim 2, wherein the fluid conductor
comprises a straw portion that facilitates placement of the fluid
port at a location distal to the wound.
4. The wound-care assembly of claim 2, wherein a therapeutic agent
is applied to the wound via the fluid port.
5. The wound-care assembly of claim 4, wherein the therapeutic
agent is thermally augmented.
6. The wound-care assembly of claim 1, wherein the fiber-optic
strands are arranged in a flat, side-by-side, configuration.
7. The wound-care assembly of claim 1, comprising a window formed
in the base layer, the window facilitating fluid communication
between the wound and the fluid conductor.
8. The wound-care assembly of claim 7, comprising a mesh extending
across the window.
9. The wound-care assembly of claim 7, comprising a radio-frequency
(RF) antenna disposed around a circumference of the window.
10. The wound-care assembly of claim 1, wherein the fluid conductor
facilitates reduction of pressure at the wound from ambient
pressure.
11. A method of utilizing a wound-care assembly, the method
comprising: applying a fiber-optic patch to a wound; pressing the
fiber-optic patch into contact with an inner surface of the wound
via a fluid conductor; applying a vacuum applicator to the fluid
conductor; applying ultraviolet light to the wound via the
fiber-optic patch; and applying a relative vacuum to the wound via
the fluid conductor.
12. The method of claim 11, comprising securing the fluid conductor
and the fiber-optic patch to the wound.
13. The method of claim 11, comprising applying a therapeutic agent
to the wound via the fluid conductor.
14. The method of claim 13, comprising thermally augmenting the
therapeutic agent.
15. The method of claim 11, comprising applying a pulsed
radio-frequency (RF) signal to the wound area via a radio-frequency
antenna.
16. The method of claim 11, wherein the applying ultraviolet light
comprises modulating the applied ultraviolet light.
17. The method of claim 11, wherein the applying a relative vacuum
comprises fluidly coupling the vacuum applicator to a straw portion
of the fluid conductor at a location distal to the wound.
18. The method of claim 11, comprising shaping the fluid conductor
to approximately match a size and a shape of the wound.
19. The method of claim 11, wherein the applying a relative vacuum
to a wound facilitates removal of undesirable materials from the
wound.
20. The method of claim 11, wherein the fiber-optic patch comprises
fiber-optic strands arranged in a flat side-by-side configuration.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 15/596,743, filed on May 16, 2017. U.S. patent
application Ser. No. 15/596,743 is a continuation of U.S. patent
application Ser. No. 14/537,255, filed on Nov. 2, 2014. U.S. patent
application Ser. No. 14/537,255 claims priority to U.S. Provisional
Patent Application No. 61/902,455, filed Nov. 11, 2013. U.S. patent
application Ser. No. 15/596,743, U.S. patent application Ser. No.
14/537,255, and U.S. Provisional Patent Application No. 61/902,455
are each incorporated herein by reference.
BACKGROUND
Field of the Invention
[0002] The present invention relates to a wound care method and
system with one or both of vacuum-light therapy, pulsed radio
frequency ("RF"), and oxygenation, and more particularly, but not
by way of limitation, to adaptive wound-care patch capable of being
utilized in a variety of wound locations where one or both of
vacuum-light therapy, pulsed radio frequency ("RF"), and
oxygenation may be applied thereto.
History of the Related Art
[0003] 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.
[0004] 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.
[0005] 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.
SUMMARY
[0006] The present invention relates generally to a wound care
method and system with one or both of vacuum-light therapy, pulsed
radio frequency ("RF"), and oxygenation, and more particularly, but
not by way of limitation, to adaptive wound-care patch capable of
being utilized in a variety of wound locations where one or both of
vacuum-light therapy, pulsed radio frequency ("RF"), and
oxygenation may be applied thereto.
[0007] In one aspect, the present invention relates to a wound-care
assembly The wound-care assembly includes a base layer. A film
layer is operatively coupled to the base layer and a fluid
conductor is in fluid communication with a wound and a vacuum
source. The wound-care assembly further includes a fiber-optic
patch comprising a plurality of fiber-optic strands. The
fiber-optic strands are pressed into contact with an interior
surface of the wound by the fluid conductor. The fiber-optic patch
provides ultraviolet light to the wound and the relative vacuum is
applied to the wound via the vacuum source and the fluid
conductor.
[0008] In another aspect, the present invention relates to a method
of utilizing a wound-care assembly. The method includes applying a
fiber-optic patch to a wound. The fiber-optic patch is pressed into
contact with an inner surface of the wound via a fluid conductor.
The fluid conductor and the fiber-optic patch are secured to the
wound. A vacuum applicator is applied to and secured to the fluid
conductor. Ultraviolet light is applied to the wound via the
fiber-optic patch and a relative vacuum is applied to the wound via
the fluid conductor.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] For a more complete understanding of the present invention
and for further objects and advantages thereof, reference may now
be had to the following description taken in conjunction with the
accompanying drawings in which:
[0010] FIG. 1A is a top view of a wound-care patch according to an
exemplary embodiment;
[0011] FIG. 1B is an exploded view of the wound-care patch of FIG.
1A according to an exemplary embodiment;
[0012] FIG. 1C is a perspective view of the wound-care patch of
FIG. 1A according to an exemplary embodiment;
[0013] FIG. 2 is a bottom view of the wound-care patch of FIG. 1
according to an exemplary embodiment;
[0014] FIG. 3 is a flow diagram of a method for using the
wound-care patch of FIG. 1 according to an exemplary
embodiment;
[0015] FIG. 4A is a top view of a package containing a wound-care
assembly according to an exemplary embodiment;
[0016] FIG. 4B is a an exploded view of the wound-care assembly of
FIG. 4A;
[0017] FIG. 5A is a bottom view of the wound-care assembly of FIG.
4 applied to a foot according to an exemplary embodiment;
[0018] FIG. 5B is a top view of the wound-care assembly of FIG. 4
applied to a foot according to an exemplary embodiment; and
[0019] FIG. 6 is a flow diagram of a method for using the
wound-care patch of FIG. 4 according to an exemplary
embodiment.
DETAILED DESCRIPTION
[0020] 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.
[0021] FIG. 1 is a top view of a wound-care patch 100. The
wound-care patch 100 includes a base layer 102 that is coupled to a
film layer 104. In a typical embodiment, the base layer 102 is
constructed of a sterile, ethylyne-oxide, biocompatible material.
The film layer 104 is, in a typical embodiment, constructed from,
for example, medical grade polyurethane. A peripheral edge 106 of
the film layer 104 is secured to a corresponding edge of the base
layer 102 through a process such as, for example, welding.
Connection of the film layer 104 to the base layer 102 creates a
seal around the peripheral edge 106, which seal prevents leakage of
fluid therefrom. A fluid port 114 is formed in the film layer
104.
[0022] Still referring to FIG. 1, a fluid conductor 108 is disposed
between the base layer 102 and the film layer 104. In a typical
embodiment, the fluid conductor 108 is flexible, absorptive, and
constructed of, for example, medical grade foam. The fluid
conductor includes a wound-treatment portion 110 disposed proximate
a wound (not shown in FIG. 1) and a straw portion 112 that fluidly
couples the wound-treatment portion 110 to the fluid port 114. In a
typical embodiment, the fluid conductor 108 transmits fluids such
as, for example, liquids or gases, from the wound to the fluid port
114 and, thus, allows a vacuum to be applied to the wound via the
fluid port 114. In addition, the straw portion 112 facilitates
placement of the fluid port 114 at a location removed from the
wound. Such an arrangement is beneficial if, for example, space
constraints do not allow the fluid port 114 to be placed near the
wound.
[0023] Still referring to FIG. 1, a fiber-optic cable 116 is
coupled to the wound-care patch 100. A plurality of fiber-optic
strands 118 extend from the fiber-optic cable 116. The fiber-optic
strands are disposed between the base layer 102 and the film layer
104 and are arranged in a generally flat, side-by-side
configuration. The fiber-optic strands 118 are disposed beneath the
fluid conductor 108.
[0024] FIG. 1B is an exploded view of the wound-care patch 100.
FIG. 1C is a perspective view of the wound-care patch 100. FIG. 2
is a bottom view of the wound-care patch 100. Referring to FIGS.
1B-2 together, a window 120 is formed in a bottom face of the base
layer 102. The fiber-optic strands 118 extend across the window
120. The wound-treatment portion 110 of the fluid conductor 108
(shown in FIG. 1A) is disposed over the window 120 above the
fiber-optic strands 118. In a typical embodiment, the wound-care
patch 100 is arranged such that the window 120 is positioned over
the wound. A mesh 121 extends across the window 120 below the
fiber-optic strands 118. In a typical embodiment, the mesh 121
prevents adhesion of wound tissue to either the fiber-optic strands
118 or the fluid conductor 108. A biocompatible skin adhesive (not
shown) such as, for example, Tegaderm.TM., manufactured by 3M
Company (hereinafter "Tegaderm"), is used to secure the edges of
the wound-care patch 100 to skin surrounding the wound.
[0025] During operation, a vacuum pump (not explicitly shown) is
coupled to the fluid port 114. Such an arrangement allows a
relative vacuum to be applied to the wound via the fluid conductor
108. In addition, a source of ultra-violet light (not explicitly
shown) is coupled to the fiber-optic strands 118. The ultra-violet
light is emitted from the fiber-optic strands 118 into the wound.
The ultraviolet light emitted from the fiber-optic strands 118 may
be modulated to create various patterns of light, different
intensities of light, and different durations of light such as, for
example, pulsed emission of ultraviolet light. The ultraviolet
light is capable of penetrating through several layers of skin to
destroy infectious bacteria. According to exemplary embodiments,
the ultraviolet light from fiber-optic strands 118 destroys a wide
variety of microorganisms such as, for example, bacteria which
causes skin infections. In addition, the ultraviolet light from the
fiber-optic strands 118 improves wound healing along with cell and
bone growth. Furthermore, the use of ultraviolet light in light
therapy is safe, non-invasive, drug-free and therapeutic.
[0026] Still referring to FIGS. 1C-2, in various embodiments, a
therapeutic agent, such as, for example, concentrated oxygen may be
applied to the wound site via the port 114. In such embodiments,
the port 114 may include two parallel lumen couplings to facilitate
alternating application of the therapeutic agent and the relative
vacuum. In various embodiments, the therapeutic agent may be
thermally augmented prior to application to the wound area. In
other embodiments, the therapeutic agent is not thermally
augmented. Still referring to FIGS. 1C-2, in various embodiments, a
radio frequency ("RF") antenna 122 is disposed around the window
120. In a typical embodiment, the RF antenna 122 comprises a wire
124. The wire 124 extends around a perimeter of the window 120. In
a typical embodiment, the wire 124 is disposed such that, during
use, the wire 124 is in close proximity to the wound. In various
embodiments, the wire 124 is insulated to reduce risk of electric
shock to a patient.
[0027] Still referring to FIGS. 1C-2, during operation, a pulsed
radio-frequency ("RF") signal having a pulse frequency on the order
of, for example 27 MHz, is transmitted to the RF antenna 122. 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 RF antenna 122 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. Exposing the wound 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.
[0028] FIG. 3 is a flow diagram of a process 300 for using the
wound-care patch 100. The process 300 begins at step 302. At step
304, the wound-care patch 100 is applied to a wound. At step 306, a
biocompatible skin adhesive is used to secure the edges of the
wound care patch 100 to a patient's skin surrounding the wound. At
step 308, the fluid port 114 is coupled to a vacuum source and the
fiber-optic cable 116 is connected to an ultraviolet light source.
At step 310, a relative vacuum is applied to the fluid port 114.
The relative vacuum is transmitted to the wound via the fluid
conductor 108. In various embodiments, the relative vacuum
facilitates removal of undesirable tissues from the wound such as,
for example, dead tissue and foreign contaminants. In addition, the
relative vacuum draws out fluid from the wound thereby increasing
blood flow into the wound area. At step 312, ultraviolet light is
supplied to the wound via the fiber-optic cable 116 and the
fiber-optic strands 118. In a typical embodiment, the ultraviolet
light is supplied to the wound area simultaneous with the
application of the relative vacuum. In other embodiments, at least
one of the ultraviolet light and the relative vacuum may be
modulated or applied in various patterns and, thus, may not be
simultaneous. The process 300 ends at step 314.
[0029] FIG. 4A is a top view of a package 401 containing a
wound-care assembly 400. FIG. 4B is an exploded view of the
wound-care assembly 400. Referring to FIGS. 4A and 4B together, the
wound-care assembly 400 includes a fiber-optic patch 402. The
fiber-optic patch includes a plurality of fiber-optic strands 404.
In a typical embodiment, the plurality of fiber-optic strands 404
are arranged in a generally flat side-by-side arrangement. The
plurality of fiber-optic strands 404 are optically coupled to a
fiber-optic cable 406. In a typical embodiment, the fiber-optic
cable 406 is optically connectable to a source of ultraviolet
light. The wound-care assembly 400 further includes a vacuum
applicator 408. The vacuum applicator 408 includes a base layer 412
and a film layer 414. A fluid port 410 is formed in the film layer
414. A fluid conductor 416 is disposed beneath the fluid port 410
between the film layer 414 and the base layer 412. In a typical
embodiment, the fluid conductor 416 is flexible, absorptive, and
constructed of, for example, medical grade foam. In a typical
embodiment, the fluid port 410 is connectable to a vacuum source.
In a typical embodiment, the package 401 maintains the wound-care
assembly in a sterile environment until use.
[0030] Still referring to FIGS. 4A and 4B, an RF layer 403 is
disposed above the fiber-optic patch 402. The RF layer 403 includes
an antenna 405 embedded therein. In a typical embodiment, the
antenna 405 forms a loop around the wound. 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
405. 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 405 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. Exposing the wound 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.
[0031] FIG. 5A is a bottom view of the wound-care assembly 400
applied to a foot 502 of a patient. FIG. 5B is a top view of the
wound-care assembly 400 applied to a foot 502 of a patient. As
illustrated in FIGS. 5A-5B a wound 504 is present on the foot 502.
The wound 504 is illustrated by way of example in FIG. 5 as being
present on the foot 502; however, in other embodiments, the wound
504 may be disposed on any bodily region of the patient. The
fiber-optic patch 402 is positioned over the wound 504 in such a
manner that the fiber-optic strands 404 extend across a width of
the wound 504. A fluid conductor 506 is shaped to approximately
match a shape of the wound 504. In a typical embodiment, the fluid
conductor 506 is flexible, absorptive, and constructed of, for
example, medical grade foam. The fluid conductor 506 may cut or
otherwise shaped to approximately match a size and shape of the
wound 504. The fluid conductor 506 is positioned above the
fiber-optic patch 402 and pressed downwardly into the wound 504
thereby pressing the fiber-optic strands 404 into contact with an
interior surface of the wound 504. In various embodiments, a straw
portion 508 may be fluidly coupled to the fluid conductor 506. In a
typical embodiment, the straw portion 508 is constructed from a
material similar to that of the fluid conductor 506. The straw
portion 508 allows a relative vacuum to be applied to the wound
504, via the vacuum applicator 408, when the fluid port 410 is
disposed a location remote to the wound 504 such as, for example,
on a top of the foot 502. Such an arrangement is advantageous in
situations where the wound 504 is located in a space-confined area
such as, for example, a bottom of the patient's foot 502. The
fiber-optic patch 402, the fluid conductor 506, and the straw
portion 508 are secured in place via a biocompatible skin adhesive
such as, for example, tegaderm.
[0032] Still referring to FIGS. 5A-5B, a small hole is formed in
the biocompatible skin adhesive at a location where the vacuum
applicator 408 is to be applied. In various embodiments, the vacuum
applicator 408 is applied above the fluid conductor 506; however,
in other embodiments, the vacuum applicator 408 may be applied to
the straw portion 508. The vacuum applicator 408 is secured via a
biocompatible skin adhesive such as, for example, tegaderm. In a
typical embodiment, the wound-care assembly 400 facilitates
flexible and modular construction for use on a wide variety of
bodily areas and wound types.
[0033] FIG. 6 is a flow diagram of a process 600 for using the
wound-care patch 400. The process 600 starts at step 602. At step
604, the fiber-optic patch 402 is placed over the wound 504. At
step 606, the fluid conductor 506 is sized to approximately match a
size and shape of the wound 504. At step 608, the fluid conductor
506 is pressed into the wound 504 above the fiber-optic patch 402.
The fluid conductor 506 presses the fiber-optic strands 404 into
contact with an inner surface of the wound 504. At step 610, a
straw portion 508 is constructed in fluid communication with the
fluid conductor 506. At step 612, the fiber-optic patch 402, the
fluid conductor 506, and the straw portion 508 are secured with a
biocompatible skin adhesive such as, for example, tegaderm. At step
614, the vacuum applicator is applied to at least one of the straw
portion 508 or the fluid conductor 506.
[0034] Still referring to FIG. 6, at step 616, the fiber-optic
cable 406 is connected to a source of ultraviolet light and the
vacuum applicator 408 is fluidly coupled to a vacuum source. At
step 618, a relative vacuum is applied to the wound 504 via the
vacuum applicator 408, the fluid conductor 506, and, in some
embodiments, the straw portion 508. In various embodiments, the
relative vacuum facilitates removal undesirable tissues from the
wound 504. At step 620, ultraviolet light is applied to the wound
504 via the fiber-optic cable 406, the fiber-optic patch 402, and
the fiber-optic strands 404. In a typical embodiment, the
ultraviolet light is supplied to the wound 504 simultaneous with
the application of the relative vacuum. In other embodiments, at
least one of the ultraviolet light and the relative vacuum may be
modulated or applied in various patterns and, thus, may not be
simultaneous. The process 600 ends at step 622.
[0035] Although various embodiments of the method and system of the
present invention have been illustrated in the accompanying
Drawings and described in the foregoing Specification, it will be
understood that the invention is not limited to the embodiments
disclosed, but is capable of numerous rearrangements,
modifications, and substitutions without departing from the spirit
and scope of the invention as set forth herein. It is intended that
the Specification and examples be considered as illustrative
only.
* * * * *