U.S. patent application number 12/993776 was filed with the patent office on 2011-06-02 for wound healing device.
Invention is credited to Moris Topaz.
Application Number | 20110130712 12/993776 |
Document ID | / |
Family ID | 41131233 |
Filed Date | 2011-06-02 |
United States Patent
Application |
20110130712 |
Kind Code |
A1 |
Topaz; Moris |
June 2, 2011 |
WOUND HEALING DEVICE
Abstract
This invention provides wound healing systems, which delivers
oxygen to the wound bed and applies negative pressure thereto,
where the source of oxygen and negative pressure are simultaneously
applied to distal sites of the dressing. Methods of treating wounds
and methods of treating or preventing anaerobic infection of wounds
using such systems are described.
Inventors: |
Topaz; Moris; (Hacovesh,
IL) |
Family ID: |
41131233 |
Appl. No.: |
12/993776 |
Filed: |
May 20, 2009 |
PCT Filed: |
May 20, 2009 |
PCT NO: |
PCT/IL09/00500 |
371 Date: |
February 9, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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61071847 |
May 21, 2008 |
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61071848 |
May 21, 2008 |
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61118847 |
Dec 1, 2008 |
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Current U.S.
Class: |
604/23 |
Current CPC
Class: |
A61M 2202/0208 20130101;
A61F 13/00029 20130101; A61F 13/00068 20130101; A61M 1/0088
20130101; A61M 2205/84 20130101; A61M 1/0025 20140204; A61M 2205/15
20130101; A61M 1/0031 20130101; A61M 2205/3389 20130101; A61F
13/00038 20130101; A61M 1/0084 20130101; A61P 17/02 20180101; A61M
1/0037 20130101; A61M 35/30 20190501; A61F 2013/00174 20130101;
A61F 2013/0017 20130101; A61M 2205/33 20130101 |
Class at
Publication: |
604/23 |
International
Class: |
A61M 37/00 20060101
A61M037/00 |
Claims
1.-44. (canceled)
45. A wound healing system, comprising: a dressing for wound
containment; a first inlet in said dressing, wherein said first
inlet is operationally connected to a source for the application of
negative pressure to a wound covered by said dressing; a second
inlet in said dressing, wherein said second inlet is located
distally to said first inlet and wherein said second inlet is
operationally connected to a source for the application of oxygen
flow, which conducts oxygen to a wound covered by said dressing;
and a regulator for said source for the application of negative
pressure to supply at least 20-500 mmHg of pressure.
46. The system of claim 45, wherein said dressing is compressible,
elastic or a combination thereof.
47. The system of claim 45, wherein said dressing is of a dimension
which accommodates the area of the wound and cavity.
48. The system of claim 45, wherein said dressing is fluid
permeable.
49. The system of claim 48, wherein said dressing further comprises
a second layer comprising a gas or fluid impermeable material.
50. The system of claim 48, wherein said second layer comprises an
indicator that is distinguishable upon application of negative
pressure.
51. The system of claim 50, wherein said indicator is a pattern
which deforms upon application of negative pressure.
52. The system of claim 51, wherein said indicator is a color
change upon application of negative pressure.
53. The system of claim 45, wherein said regulator applies
continuous or interrupted synchronized negative pressure.
54. The system of claim 45, wherein said regulator comprises a
valve which selectively applies negative pressure to individual
inlets.
55. The system of claim 45, wherein said application of negative
pressure is in an alternating or sequential manner.
56. The system of claim 45, further comprising a fluid trap
operationally connected to said first inlet and said source for the
application of negative pressure, such that fluid from a wound
covered by said dressing is conveyed to said fluid trap.
57. The system of claim 56, wherein said fluid trap further
comprises a detector moiety which senses a fluid level in said trap
and regulates application of said negative pressure in response to
achieving a defined fluid level or a change in fluid
characteristics.
58. The system of claim 56, wherein said fluid trap further
comprises an access port for sampling wound fluids.
59. The system of claim 56, wherein said fluid trap further
comprises a filter positioned between said fluid trap and said
source for the application of negative pressure for preventing
access of wound fluids to the source for the application of
negative pressure.
60. The system of claim 45, further comprising a regulator for said
source for the application of oxygen to supply a as mixture
composed of at least 21% oxygen.
61. The system of claim 60, wherein said regulator is also for the
application of negative pressure to supply at least 20-500 mmHg of
pressure.
62. The system of claim 61, wherein said regulator applies oxygen
and negative pressure in an alternating manner.
63. The system of claim 61, wherein said regulator applies oxygen
and negative pressure in a concurrent manner
64. The system of claim 45, further comprising a filter positioned
between said source for the application of oxygen and said
dressing, for prevention of contamination of said wound.
65. The system of claim 45, wherein said dressing further comprises
an oxygen sensor.
66. The wound healing system of claim 45, further comprising: a
first absorptive layer and a second impermeable layer; wherein said
first layer is positioned proximal to said wound, and said second
layer is distal to said wound and wherein said dressing is
compartmentalized into sections, such that negative pressure is
independently applied to each of said sections; at least a second
and third inlet operationally connected to a source for the
application of negative pressure and operationally connected
independently to said sections; whereby application of negative
pressure to said dressing is unequal, such that a first portion of
said dressing proximal to said second or third inlet is
differentially subjected to negative pressure in comparison to a
second portion of said dressing distal to said second or third
inlet.
67. The system of claim 66, wherein said first portion is subjected
to negative pressure and said second portion is not subjected to
negative pressure.
68. The system of claim 66, further comprising a regulator for said
source for the application of negative pressure to supply at least
20-500 mmHg of pressure.
69. The system of claim 68 wherein said regulator comprises a valve
which selectively applies negative pressure to individual
inlets.
70. The system of claim 66, further comprising forth and fifth
inlets, wherein application of negative pressure may be to up to
three inlets concurrently.
71. A method of treating a wound in a subject, said method
comprising the steps of applying a source of oxygen containing to a
wound in said subject and concurrently applying negative pressure
to said wound, wherein said source of oxygen maintains oxygen at a
value of at least 21% of the total gas in said source and whereby
application of oxygen and negative pressure to said wound
stimulates wound healing.
72. The method of claim 71, said method comprising: applying the
wound healing system of claim 1 to said wound such that said wound
is substantially covered by said dressing; applying negative
pressure to said first inlet in said dressing; and concurrently or
temporally applying oxygen to said second inlet.
73. The method according to claim 72, wherein said dressing is
comprised of a first layer, which is gas permeable having a
plurality of discrete oxygen passageways overlying the wound and
through which negative pressure established by the negative
pressure source is communicated to the wound.
74. The method of claim 71, wherein said wound is a result of
trauma, an infection, peripheral vascular disease or a
diabetes-associated complication.
75. The method of claim 74, wherein said infection is with an
anaerobic or facultative anaerobic organism.
76. The method claim 74, wherein said method further comprises
administering an antiseptic, antibiotic, analgesic, or an
anti-inflammatory medicament to said subject.
77. The method of claim 74, wherein said dressing incorporates an
antiseptic, antibiotic, analgesic, or an anti-inflammatory
medicament.
78. The method of claim 71, wherein said method further comprises
the step of determining a blood pressure proximal to a body region
containing said wound and applying said negative pressure at a
strength which is less than said blood pressure.
79. A method of treating or preventing anaerobic infection of a
wound in a subject, said method comprising the steps of applying a
source of oxygen containing to a wound in said subject and
concurrently applying negative pressure to said wound, wherein said
source of oxygen maintains oxygen at a value of at least 21% of the
total gas in said source and whereby application of oxygen and
negative pressure to said wound treats or prevents anaerobic
infection of said wound.
80. The method of claim 79, said method comprising: applying the
wound healing system of claim 1 to a wound in a subject at risk for
or suffering from an anaerobic infection of said wound, such that
said wound is substantially covered by said dressing; applying
negative pressure to said first inlet in said dressing; and
concurrently or temporally applying oxygen to said second
inlet.
81. The method according to claim 80, wherein said dressing is
comprised of a first layer, which is gas permeable having a
plurality of discrete oxygen passageways overlying the wound and
through which negative pressure established by the negative
pressure source is communicated to the wound.
82. The method of claim 79, wherein said wound is a result of
trauma, an infection, peripheral vascular disease or a
diabetes-associated complication.
83. The method of claim 82, wherein said infection is with an
anaerobic or facultative anaerobic organism.
84. The method claim 82, wherein said method further comprises
administering an antiseptic, antibiotic, analgesic, or an
anti-inflammatory medicament to said subject.
85. The method of claim 82, wherein said dressing incorporates an
antiseptic, antibiotic, analgesic, or an anti-inflammatory
medicament.
86. The method of claim 79, wherein said method further comprises
the step of determining a blood pressure proximal to a body region
containing said wound and applying said negative pressure at a
strength which is less than said blood pressure.
Description
FIELD OF THE INVENTION
[0001] This invention provides wound healing systems, which
comprise dressings; which may be composed of at least two layers,
which include a first absorptive and/or conductive and a second
fluid impermeable layer and which system delivers oxygen to the
wound bed and applies negative pressure thereto, where the source
of oxygen and negative pressure are simultaneously applied to
distal sites of the dressing. The system may comprise a fluid trap
for collection of conveyed fluid and/or debris, which may further
comprise a sensor for detection of changes in fluid volume or
characteristics, a sensor to detect local pressure at the wound and
distal limb, a controller to regulate differential vacuum levels
and a means to regulate and synchronize application of negative
pressure and oxygen. The invention is further directed to the
application of oxygen and negative pressure wounds for use in
treating such wounds, or treating or preventing anaerobic infection
of such wounds.
BACKGROUND OF THE INVENTION
[0002] The treatment of open wounds that do not spontaneously close
has long been a troublesome area of medical practice. These open
wounds are a result of acute wounds, contaminated wounds, burns,
extravasations and wound complications from failed surgery. Of
those, necrotizing soft-tissue infections (NSTIs) are infrequent
but highly lethal infections. They can be defined as infections of
any of the layers within the soft tissue compartment (dermis,
subcutaneous tissue, superficial fascia, deep fascia, or muscle)
that are associated with necrotizing changes. Combinations of
aerobes, anaerobes and facultative microbial agents often act
synergistically to produce skin and soft tissue infections. The
anaerobes proliferate in an environment of local tissue hypoxia in
patients following trauma, surgery or medical compromise.
Necrotizing fasciitis (NF) is a rapidly progressive inflammatory
infection, spreading through the deep fascial plane, with secondary
necrosis of the subcutaneous tissues. This deep infection causes
vascular occlusion, ischemia, and tissue necrosis. Superficial
nerves are damaged, producing the characteristic localized loss of
sensation. Most necrotizing soft tissue infections have anaerobic
bacteria present, usually in combination with aerobic gram-negative
organisms. They proliferate in an environment of local tissue
hypoxia in those patients with trauma, recent surgery, or medical
compromise. Type 1 Necrotizing Fasciitis is a mixed infection
caused by aerobic and anaerobic bacteria, and appears most commonly
following surgical procedures and in patients with peripheral
vascular disease (PVD) and diabetes. Type 2 Necrotizing Fasciitis
refers to a mono-microbial infection caused mainly by group A
streptococcus pyogenes. Pathogenesis of NF is rapid and can lead to
loss of an associated limb or life.
[0003] Once the diagnosis of NF is confirmed, treatment should be
initiated without delay. Several existing therapies such as early
and aggressive surgical debridement and exploration of necrotic
tissue, administration of systemic antibiotics, hyperbaric oxygen
(HBO) and intravenous immunoglobulin are used with mixed
success.
[0004] An ideal treatment for NF, in particular when the infection
is caused by anaerobic bacteria, is unavailable and significant
amputations and deaths result each year from NF.
SUMMARY OF THE INVENTION
[0005] In one embodiment, this invention provides a wound healing
system comprising: [0006] a dressing for wound containment; [0007]
a first inlet in said dressing, wherein said first inlet is
operationally connected to a source for the application of negative
pressure to a wound covered by said dressing; and [0008] a second
inlet in said dressing, wherein said second inlet is located
distally to said first inlet and wherein said second inlet is
operationally connected to a source for the application of oxygen
flow, which conducts oxygen to a wound covered by said
dressing.
[0009] In one embodiment, the wound healing system further
comprises a fluid trap operationally connected to said first inlet,
such that fluid from said wound fluid is conveyed to said trap,
wherein said trap further comprises a detector moiety which senses
a fluid level in said trap and regulates application of said
negative pressure in response to achieving a defined fluid level or
a change in fluid level, fluid characteristics, or a combination
thereof.
[0010] In one embodiment, the wound healing system further
comprises: [0011] a first absorptive layer and a second impermeable
layer; wherein said first layer is positioned proximal to said
wound, and said second layer is distal to said wound and wherein
said dressing is compartmentalized into sections, such that
negative pressure is independently applied to each of said
sections; [0012] at least a second and third inlet operationally
connected to a source for the application of negative pressure and
operationally connected independently to said sections; whereby
application of negative pressure to said dressing is unequal, such
that a first portion of said dressing proximal to said second or
third inlet is differentially subjected to negative pressure in
comparison to a second portion of said dressing distal to said
second or third inlet.
[0013] In some embodiments, the dressing comprises a second or
third portion of the dressing, and in some embodiments, the
dressing comprises a first impermeable layer a second absorptive
layer and a third impermeable layer; wherein said first layer is
positioned proximal to said skin, and said second layer is distal
to said wound and wherein said dressing is compartmentalized into
sections, such that negative pressure is independently applied to
each of said sections; proximal or distal to the wound.
[0014] In one embodiment, this invention provides a method of
treating a wound in a subject, said method comprising the steps of
applying a source of oxygen containing to a wound in said subject
and concurrently applying negative pressure to said wound, wherein
said source of oxygen maintains wound atmospheric oxygen at a value
of at least 21% of the total gas in said source and whereby
application of oxygen and negative pressure to said wound
stimulates wound healing.
[0015] In one embodiment, this invention provides a method of
treating or preventing anaerobic infection of a wound in a subject,
said method comprising the steps of applying a source of oxygen
containing to a wound in said subject and concurrently applying
negative pressure to said wound, wherein said source of oxygen
maintains wound atmospheric oxygen at a value of at least 21% of
the total gas in said source and whereby application of oxygen and
negative pressure to said wound treats or prevents anaerobic
infection of said wound.
[0016] In one embodiment, this invention provides a method of
treating a wound in a subject, said method comprising: [0017]
applying the wound healing system of this invention to a wound in a
subject such that said wound is substantially covered by said
dressing; [0018] applying negative pressure to said first inlet in
said dressing; and [0019] concurrently or temporally applying
oxygen to said second inlet; whereby application of oxygen and
negative pressure to said wound stimulates wound healing.
[0020] In one embodiment, this invention provides a method of
preventing or treating a wound in a subject infected with or at
risk for infection with an anaerobe, said method comprising: [0021]
applying the wound healing system of claim 1 to a wound in a
subject at risk for or suffering from an anaerobic infection of
said wound, such that said wound is substantially covered by said
dressing; [0022] applying negative pressure to said first inlet in
said dressing; and [0023] concurrently or temporally applying
oxygen to said second inlet; whereby application of oxygen and
negative pressure to said wound treats or prevents anaerobic
infection of said wound or whereby application of oxygen and
negative pressure to said wound stimulates wound healing.
[0024] In one embodiment, the methods of the invention further
comprise the step of determining a blood pressure proximal to a
body region containing said wound and applying said negative
pressure to said inlet at a strength which is less than said blood
pressure.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] Various embodiments of the subject wound healing system are
described herein with reference to the figures wherein:
[0026] FIG. 1 depicts an embodiment of a wound healing system of
this invention. The dressing (1-20), which may be comprised of a
sponge mold (1-10) and a drape attached thereto (1-15) contains an
inlet (1-30) through which negative pressure is applied (1-40) and
another inlet (1-70) positioned distally thereto, through which
oxygen is applied (1-50), whose delivery may be controlled by a
valve and regulator system (1-50) and/or an oxygen outflow
controller (1-80), which are operationally connected to the oxygen
source (1-100). The source of negative pressure may in turn be
operationally connected to a fluid trap (1-90).
[0027] FIG. 2A is a cross-sectional view of an embodied wound
healing system of the invention, illustrating the vacuum source
operationally connected to an inlet (2-10), in this embodiment, via
tubing, and an oxygen source operationally connected to a dressing
inlet (2-20), which in turn may branch into multiple oxygen inlets
positioned along the wound dressing. FIG. 2B depicts another
embodied wound healing system, where multiple dressings (2-60, 2-70
and 2-80) are connected to a single oxygen and negative pressure
source, respectively. FIG. 2C provides an embodiment of tubing
which may be used to convey oxygen to the wound, or convey fluid
from the wound, or serve as a means for the application of negative
pressure.
[0028] FIG. 3 presents an embodiment of a wound healing system of
this invention, which includes a segmental dressing, i.e. a
dressing which is divided into segments (3-50 and 3-60) and
multiple inlets for the application of negative pressure (3-10,
3-20 and 3-30) connected to a source of negative pressure (3-90)
and an inlet (3-100) for the application of oxygen (3-80), distal
to the site at which negative pressure is applied, in the segment
applied over the wound (3-40).
[0029] FIG. 4A depicts an embodiment of a cap for a fluid trap for
use with the systems of this invention, containing multiple parts.
A buoy 4-60 is contained within a net 4-70, serving as an indicator
of fluid height within the trap. Secondary buoys 4-40, may be
similarly contained within a bottle cover bottom 4-50, indicating
fluid height. A filter 4-30 may be positioned above the bottle
cover bottom to prevent contamination of the source of negative
pressure, which filter is positioned below the bottle net 4-20
placed immediately under the bottle cap 4-10, forming a closed
system. A silicone hat 4-80 may be used to ensure appropriate
positioning of the bottle cap parts within the cap. FIG. 4B depicts
the assembled form of the bottle cap in FIG. 4A. FIG. 4C depicts
the assembled cap and fluid trap container.
[0030] FIG. 5 presents photographs of skin lesions of a subject
with necrotizing facsiitis in an upper limb before, during and
after treatment according to an embodiment of a method of this
invention.
[0031] FIG. 6 presents photographs of skin lesions of another
subject with diabetic related wounds, before, during and after
treatment according to an embodiment of a method of this
invention.
[0032] FIG. 7 presents photographs of skin lesions of another
subject having burns, before, during and after treatment according
to an embodiment of a method of this invention.
[0033] FIG. 8 presents photographs of the experimental setup to
determine oxygen levels of wound sites using a phantom leg. RNPT
systems were evaluated in a side-by-side comparison study with
embodiments of RO-NPT systems of this invention. A. circumferential
dressing of leg by a sponge sealed entirely by a drape B. inlet of
oxygen flow. C. vacuum outflow insert. D. oxygen sensor at the
vacuum outflow. E. pO.sub.2 detector.
[0034] FIG. 9 depicts reduced pO.sub.2 values in a simulated wound
atmosphere at various clinical RNPT vacuum pressure level ranges,
where no supplemental oxygen is provided.
[0035] FIG. 10 depicts the measured pO.sub.2 values at various
clinically relevant oxygen flows and sub atmospheric pressure
range.
[0036] FIG. 11 plots the externally applied vacuum pressure on a
circumferential sponge dressing applied to a lower limb versus the
internal pressure within the limb.
DETAILED DESCRIPTION OF THE INVENTION
[0037] This invention provides in one embodiment a system for wound
healing comprising a dressing for wound containment, a first inlet
in said dressing, wherein said first inlet is operationally
connected to a source for the application of negative pressure to a
wound covered by said dressing and a second inlet in said dressing,
wherein said second inlet is located distally to said first inlet
and wherein said second inlet is operationally connected to a
source for the application of oxygen flow, which conducts oxygen to
a wound covered by said dressing.
[0038] The wound healing systems of this invention reduce the risk
of wound anaerobic infection, treat anaerobic infection and promote
healing of a wound via the joint application of negative pressure
and oxygen-enriched gas to the wound, wherein the negative pressure
and oxygen application are applied at distal sites, with respect to
each other. The wound healing system promotes the healing of the
wound, in some embodiments, by application of oxygen enriched gas
and negative pressure to defined segments in the dressing in
sequential or intermittant manner. The wound healing system, in
some embodiments, further comprises a fluid trap, having a sensor
and relay system, such that upon changes in a fluid volume or
spectroscopic properties in the fluid conveyed to the trap from the
wound site, the relay system alters application of negative
pressure, for example, decreasing application of negative pressure
and oxygen, halting application of negative pressure and oxygen, or
in some embodiments, increasing the application of negative
pressure and oxygen.
[0039] In one embodiment, the dressing for wound containment
further comprises a first absorptive layer and a second impermeable
layer; wherein said first layer is positioned proximal to said
wound, and said second layer is distal to said wound and wherein
said dressing is compartmentalized into sections, such that
negative pressure is independently applied to each of said
sections; and at least a second and third inlet operationally
connected to a source for the application of negative pressure and
operationally connected independently to said sections; whereby
application of negative pressure to said dressing is unequal, such
that a first portion of said dressing proximal to said second or
third inlet is differentially subjected to negative pressure in
comparison to a second portion of said dressing distal to said
second or third inlet.
[0040] This invention provides in another embodiment a system for
wound healing as described hereinabove, further comprising at least
third and fourth inlets for the application of regulated negative
pressure, which are distal to the second inlet, through which
oxygen is applied to the wound, and methods of use thereof.
[0041] In one embodiment, the term "dressing for wound containment"
refers to any dressing or bandage or material, which serves as a
barrier between the wound and the outside environment. The dressing
fabric may be comprised of any suitable material, gas and fluid
permeable, such as an ace bandage, stretch netting, or other
clothing-type item made of a stretchable material, such as SPANDEX.
The dressing, in some embodiments, has dimensions and composition
such that it is suitable for the type and size of the wound, the
location in the body in which the wound is located, the desired
wound treatment, and the individual preference of the user of the
dressing. In one embodiment, the dressing may comprise multiple
layers which may vary in absorbance capacity creating a capillary
action to facilitate flow of wound fluids from the wound. In some
embodiments, the dressing is comprised of a material which absorbs
wound fluids and provides a barrier to the outside environment over
the entire, or primarily covering the wounded area. In some
embodiments, the dressing will be compressible and elastic allowing
the application of negative pressure and the covering of the
wounded area. In some embodiments, the dressing is porous, which
allows fluid drainage from the wound. In some embodiments, the
application of the vacuum may vary in strength over a course of
application to a dressing or to a dressing compartment. In some
embodiments, the application of oxygen flow may vary over a course
of application to a dressing or to a dressing compartment. Such
application can be as a cycle, with repetitive variations in
application in terms of vacuum strength and/or oxygen flow and in
some embodiments, the pressure applied will be lower than the
perfusion pressure detectable within the treated limb or body
region.
[0042] In some embodiments, the dressing comprises a sponge, such
as will be suitable for use with human skin lesions or wounds. The
sponge, in some embodiments, is comprised of artificial polymeric
materials or naturally available materials as long as they are
suitable for use as dressing for wounds. In some embodiments; the
sponge is a combined layer sponge, where the first layer proximal
to the wound is absorptive and the second layer distal to the wound
is gas and fluid impermeable. The combined layer sponge may conform
to the shape and size of the wound. In some embodiments, the
combined layer sponge is connected to a negative pressure source
through an inlet. The inlet may be attached to said combined layer
sponge by conventional means such as adhesive, pressure application
or screw application. In some embodiments, the dressing is
comprised of materials which can be repeatedly sterilized, or in
some embodiments, are sterile single-use materials. In some
embodiments, the dressing will comprise suitable form, shape, etc.,
that conforms to the shape and size of the wound, and is
appropriate for application thereto. In some embodiments, the
sponge may vary in terms of pore diameter size or average pore
volume, compressibility or cross link density. In some embodiments
such differences in pore size and shape, etc., accommodate fluid
drainage from the wound site. In some embodiments, the dressing is
comprised of segments that are segregated from each other by a gas
and fluid impermeable barrier. Each segment can be connected to a
negative pressure source separately or in combination, resulting in
application of negative pressure to part of or the whole dressing
as determined by the treatment administrator. This allows the
application of negative pressure in part of the dressing thus
affecting part of the wound while differentially or not affecting a
nearby part of the wound or body area where negative pressure is
not needed. The segments, in one embodiment, may be in the form of
a unit which has a plurality of annular compartments. Each
compartment is connected to a negative pressure source for
pressurizing the segment. In some embodiments, control valves are
inserted between the pump and each dressing segment. Pressure
sensors maybe connected to each segment. The control valves and
pressure sensors are connected to a programmable control processor
to operate the valves and monitor the segment negative pressure
thus enhancing blood and fluid flow in the limb and reducing the
risk for deep vein thrombosis (DVT) and limb ischemia and
facilitating limb perfusion, in some embodiments by avoiding excess
negative pressure to the dressing.
[0043] In some embodiments, dressings may be changed over time, as
a function of, for example, changes in healing dynamics of the
wound. In some embodiments, for example, the sponge has a first
pore size, and is optionally exchanged with a sponge having a
second pore size, where the pore size is reduced as wound healing
progresses. In some embodiments, the dressing may comprise
materials whose mean pore size or pore volume density varies
throughout the dressing. In some embodiments, the region of the
dressing comprising a larger pore size is placed proximal to the
wound to allow the fast flow and clearance of wound fluids and
debris from the wounded area, and a region of the dressing
comprising a smaller pore size is situated more distal to the wound
site, and more proximal to the source of negative pressure. In some
embodiments the reverse is effected, such that smaller pore size
regions of the dressing are placed proximal to the wound area, in
order that the wound is subjected to less adhesion of the sponge,
whereas regions of the dressing comprising a larger pore size is
placed distal to the wound site and proximal to the source of
negative pressure to maximize application of pressure thereto and
thereby stimulate effective wound drainage.
[0044] The term "negative pressure" as used herein is to be
considered synonymous with the terms "vacuum" or "subatmospheric
pressure".
[0045] In some embodiments, the dressing and inlets therein are so
positioned or structured such that the application from the source
of oxygen and source of negative pressure, via the inlets or
tubing, for example, are oriented distally with respect to each
other along a single Cartesian axis, for example along a horizontal
axis of the dressing. In some embodiments, according to this
aspect, when a dressing is placed over a wound, and the wound
comprises an area from left to right along a horizontal axis, the
oxygen source is proximal for example, at the right-most edge of
the dressing whereas negative pressure is applied at the left-most
edge of the dressing. In some embodiments, the source or sources of
oxygen and source or sources of negative pressure are oriented
distally with respect to each other along a different Cartesian
axis. For example, and in one embodiment, the source of oxygen is a
region of the dressing proximal to the wound and the source of
negative pressure is at a region distal to the wound along all
Cartesian axes, for example, along a horizontal axis the oxygen
source is applied to the middle of the wound area, whereas negative
pressure is applied along a z axis most distal to the region of
applied oxygen. In some embodiments, such arrangement facilitates
directing oxygen flow to the wound site, conveyed by the front
created by application of negative pressure. In some embodiments,
several inlets for the application of negative pressure are
deposited along a Cartesian axis, each in a different separated
segment of the dressing as describe above. In some embodiment,
these inlets are connected to a negative pressure through a valve
which controls the application of negative pressure to one or more
inlets at the same time.
[0046] In some embodiments, the dressing comprises commercial
dressing materials, for example, XEROFLO.RTM. by Kendall Corp, or
any available sponge dressing, for example as commonly sold by
commercial vendors, such as Johnson and Johnson.RTM. or
Micromat.RTM. sold by Sion Misgav Am Israel.
[0047] In some embodiments, the dressing is transparent. In some
embodiments, the dressing comprises a resilient, liquid absorbent,
porous, polymer-based sponge. In some embodiments, the dressing
comprises a sponge comprising a dispensable liquid which at least
partially solidifies to a crystal-like arrangement defining hollow
tubes to allow for exudate drainage. In some embodiments, the
dressing comprises a sponge dispensed within the wound bed, which
is potentially collapsible to expel air from the sponge channels
allowing the drainage of fluids from the wounded area. In some
embodiments, the sponge may be expandable sponge which is capable
of absorbing fluid from a wound and maintain the wound bed moist.
In some embodiments, the sponge or the covering drape may
incorporate a printed pattern, where the pattern deforms upon
application of negative pressure. This serves as a visual indicator
for the presence of negative pressure. In some embodiments, the
pattern may comprise a drawing or printed word or a combination of
the two where a visual change in the drawing and/or printed word
indicates application or loss of negative pressure. In some
embodiments, the indicator for application of negative pressure may
be a color change. Upon application of negative pressure, a color
print on the dressing may change color due to a change in
elasticity, shape or size of the dressing indicating the
availability of negative pressure applied to the dressing. The
hollow tubes or voids defined by the sponge in some embodiments,
may also provide a means to conduct electricity, heat, cold,
fluids, gases negative pressure and ultrasound enabling additional
treatments to be administered or tests to be done in parallel to
treating the wound. In some embodiments, the hollow conduits, tubes
or voids may also provide a bioactive scaffold for tissue growth,
one possibility is that sponge is biodegradable thus allowing
tissue regeneration without the need for sponge removal, scaffold
or tissue regeneration or structuring. In one embodiment, a thin
film transparent top layer is secured about the wound area to
enclose the wound and seal the wound from atmospheric gases and
potential infecting microorganisms.
[0048] In some embodiments, the dressings comprise hydrogels,
medicaments and slow release medicaments, which may treat the
wound, promote healing and reduce pain associated with dressing
changes or removal. In some embodiments, medicaments include, for
example, antimicrobial agents, growth factors, degradative enzymes,
antibiotics, analgesics, and the like. In one embodiment, the
medicaments are an anti-infective agent. In one embodiment, the
anti-infective agent is an antibiotic agent. In one embodiment
beta-lactam antibiotics include but are not limited to penicillin,
benzathine penicillin, benzylpenicillin, amoxicillin, procaine
penicillin, dicloxacillin, amoxicillin, flucloxacillin, ampicillin,
methicillin, azlocillin, carbenicillin, ticarcillin, mezlocillin,
piperacillin, phenoxymethylpenicillin, co-amoxiclav, cephalosporin,
cefalexin, cephalothin, cefazolin, cefaclor, cefuroxime,
cefamandole, cefotetan, cefoxitin, ceftriaxone, cefotaxime,
ceftazidime, cefepime, cefpirome, imipenem, meropenem, ertapenem,
faropenem, monobactam, aztreonam, or carbapenem.
[0049] In some embodiments, the dressings as described hereinabove,
with respect to the materials utilized in construction of the same,
may be arranged as layers, which vary in terms of their absorptive
capacity, and are arranged such that the least absorptive material
is the outermost layer of the dressing, or vice versa. In some
embodiments, the dressings specifically incorporate a material
which is fluid-impermeable, such as, for example, a plastic or
nylon thin layer or sheath, which prevents fluid exchange with the
environment. Suitable material for the fluid-impermeable may be any
conventional material, for example, plastic film paper product,
metallic foil, laminates or any other material which will be
impermeable to fluids.
[0050] In some embodiments, the dressings incorporate an
antibiotic. In one embodiment the antibiotic is a tetracycline
antibiotic. In one embodiment tetracycline antibiotics include but
are not limited to tetracycline, chlortetracycline, demeclocycline,
doxycycline, lymecycline, minocycline, or oxytetracycline.
[0051] In one embodiment the antibiotic is a macrolide antibiotic.
In one embodiment macrolide antibiotics include but are not limited
to erythromycin, azithromycin, oxithromycin, dirithromycin,
clarithromycin, josamycin, oleandomycin, kitasamycin, spiramycin,
tylosin/tylocine, troleandomycin, carbomycin, cethromycin, or
telithromycin.
[0052] In one embodiment the antibiotic is an aminoglycoside
antibiotic. In one embodiment, aminoglycoside antibiotics include
but are not limited to gentamicin, tobramycin, faropenem, imipenem,
kanamycin, neomycin, ertapenem, apramycin, paromomycin sulfate,
streptomycin, or amikacin.
[0053] In one embodiment the antibiotic is a quinolone antibiotic.
In one embodiment quinolone antibiotics include but are not limited
to ciprofloxacin, norfloxacin, lomefloxacin, enoxacin, ofloxacin,
ciprofloxacin, levofloxacin, sparfloxacin, gatifloxacin,
moxifloxacin, trovafloxacin, or alatrofloxacin.
[0054] In one embodiment the antibiotic is a cyclic peptide
antibiotic. In one embodiment cyclic peptide antibiotics include
but are not limited to vancomycin, streptogramins, Microcin J25,
Bacteriocin AS-48, RTD-1, or polymyxins.
[0055] In one embodiment the antibiotic is a lincosamide
antibiotic. In one embodiment lincosamide antibiotics include but
are not limited to clindamycin.
[0056] In one embodiment, the antibiotic is an oxazolidinone
antibiotic. In one embodiment oxazolidinone antibiotics include but
are not limited to linezolid, U-100592, DA-7867, AZD2563, or
U-100766.
[0057] In one embodiment, the antibiotic is a sulfa antibiotic. In
one embodiment, sulfa antibiotics include but are not limited to
sulfisoxazole.
[0058] In one embodiment, the antibiotic is an antiseptic agent. In
one embodiment, antiseptic agents include but are not limited to
alcohols, chlorhexidine, chlorine, hexachlorophene, iodophors,
chloroxylenol (PCMX), quaternary ammonium compounds, or
triclosan.
[0059] In one embodiment, the antibiotic is an anti-tuberculosis
agent. In one embodiment an anti-tuberculosis agents include but
are not limited to ethambutol, rifabutin, isoniazid, rifampicin,
pyrazinamide, or rifampin
[0060] In one embodiment, the antibiotic is an antifungal agent. In
one embodiment, antifungal agents include but are not limited to
terbinafine, flucytosine, fluconazole, itraconazole, ketoconazole,
ravuconazole, posaconazole, voriconazole, caspofungin, micafungin,
v-echinocandin, amphotericin B, amphotericin B lipid complex
(ABLC), amphotericin B colloidal dispersion (ABCD), liposomal
amphotericin b (l-Amb), liposomal nystatin, or griseofulvin.
[0061] In one embodiment, the antibiotic is an antiprotozoal agent.
In one embodiment the antiprotozoal agent is an antimalarial agent.
In one embodiment, antimalarial agents include but are not limited
to chloroquine, mefloquine, proguanil, pyrimethamine with dapsone,
pyrimethamine with sulfadoxine, quinine, or primaquine. In one
embodiment, the antiprotozoal agent is an amoebicide. In one
embodiment, amoebicides include but are not limited to
metronidazole, tinidazole, or diloxanide furoate. In one
embodiment, the antiprotozoal agent is an antigiadial agent. In one
embodiment, antigiadial agents include but are not limited to
metronidazole, tinidazole, or mepacrine. In one embodiment, the
antiprotozoal agent is a leishmanicide. In one embodiment,
leishmanicides include but are not limited to sodium
stibogluconate. In one embodiment, the antibiotic is an
antithelmintic agent.
[0062] In one embodiment, the antibiotic is an antiviral agent. In
one embodiment, antiviral agents include but are not limited to
abacavir, acyclovir, amantadine, didanosine, emtricitabine,
enfuvirtide, entecavir, lamivudine, nevirapine, oseltamivir,
ribavirin, rimantadine, stavudine, valaciclovir, vidarabine,
zalcitabine, or zidovudine. In one embodiment, the antiviral agent
is a nucleotide analog reverse transcriptase inhibitor. In one
embodiment, nucleotide analog reverse transcriptase inhibitors
include but are not limited totenofovir or adefovir. In one
embodiment, the antiviral agent is a protease inhibitor. In one
embodiment, protease inhibitors include but are not limited to
saquinavir, ritonavir, indinavir, nelfinavir, amprenavir,
lopinavir, fosamprenavir, or tipranavir. In one embodiment, the
antiviral agent is a fusion inhibitor such as enfuvirtide. In one
embodiment, a combination of antiviral or antiretroviral agents is
desired. In one embodiment, antiviral or antiretroviral agents or a
combination thereof, further comprise hydroxyurea, resveratrol,
grapefruit, ritonavir, leflunomide, or a combination thereof.
[0063] In one embodiment, the dressing incorporates a medicament
having a therapeutic property. In some embodiments, the medicaments
may comprise a growth factor such as epidermal growth factor (EGF),
transforming growth factor-.alpha. (TGF-.alpha.), platelet derived
growth factor (PDGF), fibroblast growth factors (FGFs) including
acidic fibroblast growth factor (.alpha.-FGF) and basic fibroblast
growth factor (.beta.-FGF), transforming growth factor-.beta.
(TGF-.beta.) and insulin like growth factors (IGF-1 and IGF-2), or
any combination thereof.
[0064] In one embodiment, the medicaments may be local anesthetic
agents. In one embodiment, local anesthetic agents include but are
not limited to benzocaine, chloroprocaine, cocaine, procaine,
bupivacaine, levobupivacaine, lidocaine, mepivacaine, prilocaine,
or ropivacaine. In one embodiment, the medicaments may be a general
anaesthetic agent. In one embodiment, general anesthetic agents
include but are not limited to esflurane, sevoflurane, isoflurane,
halothane, enflurane, methoxyflurane, xenon, propofol, etomidate,
methohexital, midazolam, diazepamor, ketamine,
thiopentone/thiopental, or lidocaine/prilocaine.
[0065] In one embodiment, the medicaments may be an analgesic
agent. In some embodiments, analgesic agents include but are not
limited to paracetamol or non-steroidal anti-inflammatory agent. In
some embodiments, analgesic agents include opiates or
morphinomimetics such as morphine, pethidine, oxycodone,
hydrocodone, diamorphine, tramadol, or buprenorphine. In some
embodiments, a combination of two or more analgesics is
desired.
[0066] In one embodiment, the medicaments may be sedative agents.
In one embodiment, the sedative agent is an antidepressant agent
such as mirtazapine or trazodone. In one embodiment, the sedative
agent is a barbiturate such as secobarbital, pentobarbital, or
amobarbital. In one embodiment, the sedative agent is a
benzodiazepine such as diazepam, clonazepam, alprazolam, temazepam,
chlordiazepoxide, flunitrazepam, lorazepam, or clorazepate. In one
embodiment, the sedative agent is an imidazopyridines such as
zolpidem or alpidem. In one embodiment, the sedative agent is a
Pyrazolopyrimidine such as zaleplon. In one embodiment, the
sedative agent is an antihistamine such as diphenhydramine,
dimenhydrinate, or doxylamine. In one embodiment, the sedative
agent is an antipsychotic agent such as ziprasidone, risperidone,
quetiapine, clozapine, prochlorperazine, perphenazine, loxapine,
trifluoperazine, thiothixene, haloperidol, or fluphenazine. In one
embodiment, the sedative agent is an herbal sedative such as
valerian plant mandrake, or kava. In some embodiments, the sedative
agent is eszopiclone, ramelteon, methaqualone, ethchlorvynol,
chloral hydrate, meprobamate, glutethimide, methyprylon,
gamma-hydroxybutyrate, ethyl alcohol, methyl trichloride,
zopiclone, or diethyl ether.
[0067] In one embodiment, the medicaments are agents treating a
wasting disease. In some embodiments, agents treating a wasting
disease include but are not limited to corticosteroids, anabolic
steroids, cannabinoids, metoclopramid, cisapride,
medroxyprogesterone acetate, megestrol acetate, cyproheptadine,
hydrazine sulfate, pentoxifylline, thalidomide, anticytokine
antibodies, cytokine inhibitors, eicosapentaenoic acid,
indomethacin, ibuprofen, melatonin, insulin, growth hormone,
clenbuterol, porcine pancreas extract, IGF-1, IGF-1 analogue and
secretagogue, myostatin analogue, proteasome inhibitor,
testosterone, oxandrolone, enbrel, melanocortin 4 receptor agonist,
or a combination thereof.
[0068] In one embodiment, the medicaments are antidiabetic agent.
In one embodiment, the antidiabetic agent is a sulfonylurea. In one
embodiment, sulfonylureas include but are not limited to
tolbutamide, acetohexamide, tolazamide, chlorpropamide, glipizide,
glyburide, glimepiride, or gliclazide. In one embodiment, the
antidiabetic agent is a meglitinide. In one embodiment,
meglitinides include but are not limited to prandin or nateglinide.
In one embodiment, the antidiabetic agent is a biguanide. In one
embodiment, biguanides include but are not limited to metformin. In
one embodiment, the antidiabetic agent is a thiazolidinedione. In
one embodiment, thiazolidinediones include but are not limited to
rosiglitazone, pioglitazone, or troglitazone. In one embodiment,
the antidiabetic agent is an alpha glucosidase inhibitor. In one
embodiment, alpha glucosidase inhibitors include but are not
limited to miglitol or acarbose. In one embodiment, the
antidiabetic agent is PPAR.alpha./.gamma. ligand,
dipeptidylpeptidase 4 (DPP-4) inhibitor, SGLT (sodium-dependent
glucose transporter 1) inhibitor, or FBPase (fructose
1,6-bisphosphatase) inhibitor. In one embodiment, the antidiabetic
agent is insulin. In one embodiment, the insulin is rapid-acting
insulin. In one embodiment, the insulin is short-acting insulin. In
one embodiment, the insulin is intermediate-acting insulin. In one
embodiment, the insulin is intermediate- and short-acting insulin
mixtures. In one embodiment, the insulin is long-acting insulin. In
one embodiment, the antidiabetic agents are inhibitors of fatty
acid binding protein (aP2) such as those disclosed in U.S. Ser. No.
09/519,079 filed Mar. 6, 2000, glucagon-like peptide-1 (GLP-1), and
dipeptidyl peptidase IV (DPP4) inhibitors such as those disclosed
in WO 0168603, which are incorporated by reference.
[0069] In one embodiment, the medicaments are anti-inflammatory
agents. In one embodiment, the anti-inflammatory agent is a
non-steroidal anti-inflammatory agent. In one embodiment, the
non-steroidal anti-inflammatory agent is a cox-1 inhibitor. In one
embodiment, the non-steroidal anti-inflammatory agent is a cox-2
inhibitor. In one embodiment, the non-steroidal anti-inflammatory
agent is a cox-1 and cox-2 inhibitor. In some embodiments,
non-steroidal anti-inflammatory agents include but are not limited
to aspirin, salsalate, diflunisal, ibuprofen, fenoprofen,
flubiprofen, fenamate, ketoprofen, nabumetone, piroxicam, naproxen,
diclofenac, indomethacin, sulindac, tolmetin, etodolac, ketorolac,
oxaprozin, or celecoxib. In one embodiment, the anti-inflammatory
agent is a steroidal anti-inflammatory agent. In one embodiment,
the steroidal anti-inflammatory agent is a corticosteroid.
[0070] In one embodiment, the medicaments may comprise anti-toxins
or other agents, which counteract poisons. In some embodiments, the
medicaments may comprise antiproliferative agents.
[0071] In some embodiments, the dressings of this invention may
comprise any medicament as described herein, or any combination
thereof, or other therapeutic compounds and combinations thereof,
as will be appreciated by the skilled artisan. In some embodiments,
this invention should be understood to encompass administering to a
subject treated by the methods or with the systems of this
invention any of the medicaments or other therapeutic compounds, as
known in the art and as described herein, wherein such
administration may be via any desired route, however such agent or
medicament is not incorporated within the dressings, in this aspect
of the invention, or in some embodiments, such medicaments are
incorporated in the dressings, and nonetheless the subject is
administered similar, identical or other medications via a route
other than delivery through the dressing.
[0072] Those skilled in the art will recognize that in some
embodiments the dressing can be formed into any suitable shape. In
some embodiments, the dressing may be adhered to the wound site by
application of an adhesive material to the dressing. In some
embodiments, the adhesive allows for dressing adhesion to the
tissue surrounding the wound bed skin, e.g., the periwound area,
and be of a material acceptable for use on skin without contact
deterioration (for example, the adhesive should be non-irritating
and non-sensitizing). Adhesives include, for example, in some
embodiments the ULTEC Hydrocolloid Dressing, by Kendall Corp., a
division of TycoHealthcare.
[0073] In some embodiments, the dressing may incorporate a flexible
material, e.g., resilient or elastomeric, that seals the dressing
resulting in a closed impermeable seal in which negative pressure
and oxygen may be administered to the wound and the wound is
protected/insulated from atmospheric gases and infecting
microorganisms. In some embodiments, for example, the dressing is a
transparent dressing manufactured under the trademark Opsite.RTM.
by Smith and Nephew. Opsite.RTM. is a transparent adhesive film
material which provides a barrier to microbes and fluid
containment. In some embodiments, the transparency provides a means
for visual indication of the status of the wound dressing and more
particularly, the status of the saturation level of the layers of
the wound dressing allowing the treating physician to monitor and
decided on the regimen for wound dressing replacements. In some
embodiments the transparent material allows for the detection of
serious malfunctions of the dressing such as excessive bleeding.
The top layer further includes a negative pressure application
inlet in fluid and gas communication with the interior of the wound
dressing. In some embodiments, the inlet may be a separate
component attached to the top layer and connected thereto by
conventional means such as adhesive, pressure application catheter
or screw application. In some embodiments, it may be integrally
formed with the top layer as part of the manufactured layer. In one
embodiment, the inlet may have a valve built therein, e.g., a one
way valve, to permit exudates to flow in one direction only, i.e.,
away from the wound dressing toward the container and negative
pressure source. In some embodiments, several inlets are deposited
along the dressing for the application of negative pressure to
specific parts of the wound dressing. In some embodiments the
dressing contains an inlet which is operationally connected to a
source of negative pressure, positioned near a region where fluid
accumulates within the affected tissue, in some embodiments, as a
consequence of gravity.
[0074] In some embodiments, it is further contemplated that the
wound healing system may incorporate external means or applications
to stimulate tissue growth and/or healing. For example, in one
embodiment, an auxiliary treatment apparatus may be incorporated
into the wound healing system to impart electrical or mechanical
energy for the treatment of the tissue such as, for instance,
directing electrical, thermal or vibratory energy on the wound area
and/or introducing various drugs into the human body through the
skin. In some embodiments, the auxiliary treatment apparatus may be
incorporated into the dressing. In some embodiments, sensor types
are also contemplated for incorporation into the wound dressing
apparatus including for example, oxygen, pressure, chemical,
microbial and/or temperature sensors. In some embodiments, the
detection of oxygen adjacent to the wound area would assist the
clinician in determining the status of wound healing while allowing
the clinician to follow and adjust the exact concentration of the
oxygen at the site of the wound. In one embodiment, a microbial
sensor may allow the clinician to follow the progress of removal of
microbial flora, especially anaerobic bacteria, from the wound
site. In some embodiments, using a temperature sensor may indicate
the presence of an elevated temperature that can be indicative of
an infection. In some embodiments, pressure sensor use may indicate
the circumferential and/or local pressure induced by the vacuum
dressing as well as the perfusion pressure to the treated area. It
is to be understood that the clinician applying the systems and
devices of this invention may regulate the applied pressure, to
ensure that the pressure is of a value below that of the peripheral
pressure measured in an area adjacent to the wound area being
treated, in order to optimize perfusion of the wound site and the
distal limb.
[0075] In some embodiments, the negative pressure source may
incorporate circuitry to communicate with a computer, e.g., a
hand-held PALM.RTM. device through wireless means resulting in no
need for wires and other restrictive connections between the wound
dressing and the monitoring appliances allowing the patient more
freedom of movement during treatment.
[0076] In some embodiments a standard vacuum line may be used for
application of negative pressure. In some embodiments, negative
pressure is achieved by use of a pump in a portable or desktop
device. In some embodiments, an example for a standard vacuum line
is a wall socket vacuum. In some embodiments, a pump applies a
negative pressure in the range of 20-500 mmHg to the wound to
effectively draw wound fluid or exudate or debris away from the
wound bed while in other embodiments, the pressure can be higher,
for example in a range of from 200-500 mmHg, to allow fast removal
of hazardous fluids or materials, such as toxic materials, from the
wounded area. In some embodiments, the negative pressure source may
be any type of pump that maintains or draws adequate and
therapeutic negative pressure levels. In some embodiments, such
pump is biocompatible. In some embodiments the negative pressure
level to be achieved is in a range between about 20 mmHg and about
500 mmHg. In some embodiments, the pump may be removable, reusable,
and/or rechargeable consistent with the need for mobility of the
patient and allowing fast changes to be made to the wound dressing.
In one embodiment, the pump is of the diaphragmatic or peristaltic
type or the like, in which the moving part(s) draw exudates out of
the wound bed into the wound dressing by creating areas or zones of
decreased pressure e.g., negative pressure zones within the wound
dressing. In some embodiments, there is a gradient of negative
pressure created. In one embodiment, the area of decreased pressure
communicates with the wound bed to facilitate removal of the fluids
therefrom and into the contact layer/sponge. In some embodiments,
the pump may be actuated by any means known by those skilled in the
art. One suitable example of a peristaltic pump, in some
embodiments, is the Kangaroo PET Enternal Feeding Pump manufactured
by Kendall Corp., a division of TycoHealthcare. In another
embodiment, a suitable example of a peristaltic pump may be the
model 101 V/R pmy MK2 manufactured by Watson Mario w LTD of
England. In some embodiments, the peristaltic pump produces
subatmospheric pressure ranging from about 20 mmHg to about 500
mmHg. For example, in one embodiment, a suitable diaphragm pump
includes model NMP 850 KNDC manufactured by KNF Neuberger of
Germany. Other suggested vendors for the supply of pumps are Fisher
Scientific, Emerson, Techno Takatsuki Co., Ltd and xenamedical
Pleupump MK II. In some embodiments, a battery operated source for
negative pressure can be used to allow patient mobility during
treatment.
[0077] The wound dressing includes an inlet for the application of
negative pressure. In some embodiments, tubing is connected to this
inlet and further connected to the source for application of
negative pressure. In some embodiments, the inlet and tubing may be
comprised of any suitable flexible, partially compressible or non
compressible tubing material fabricated from elastomeric and/or
polymeric materials. In some embodiments, the tubing is surrounded
by or comprised of a sponge material, as described hereinabove,
which in some embodiments, comprises an absorptive layer, or a soft
flat silicone tube, which forms the lumen of such tubing so that
material conveyed via the tubing is maintained therewithin, while
the external face of the tubing, which is exposed to for example,
the subject's skin, is non-permeable, non-absorptive, soft and
unlikely to leak fluid or gas, and/or unlikely to create or
exacerbate sores. In some embodiments, the tubing is comprised of a
sponge lining the lumen, and the sponge is surrounded by a
fluid-impermeable coating. In some embodiments, use of sponge-based
tubing minimizes irritation to the skin, which is in proximal
contact therewith. In some embodiments, the dressings of the
invention comprise a silicone or silicone-based flat tube (small
flat soft drain) contained within the sponge, for example, between
layers of the sponge.
[0078] In some embodiments, the dressing comprises a sponge that is
prefabricated and attached to a covering drape, as opposed to
applying a covering drape over the sponge-based dressing.
[0079] In some embodiments, the inlet tubing maybe of variable
length and size as required by the specific condition of the wound
and the physical position of the patient. In some embodiments, the
inlet tubing is releasably connected to the source of negative
pressure, for example, a vacuum port through conventional means
including a friction fit, bayonet coupling, snap fit or the like.
In some embodiments, the inlet may be embedded within the dressing
or attached by an adhesive to an opening in the dressing or
pressure inserted to the dressing. In some embodiments, the inlet
is comprised of a polymeric material suitable to withstand the
application of negative pressure.
[0080] In some embodiments, a fluid trap may be disposed "in-line"
between the negative pressure source and the wound dressing for the
removal of the drained wound fluids and to avoid contamination of
the negative pressure source. In some embodiments, the fluid trap
may be any flexible disposable pouch or the like. In some
embodiments, the fluid trap may be a non-flexible container. In
some embodiments, the fluid trap may include a super absorbent
material such as superabsorbent polymers (SAP), silica gel, sodium
polyacrylate, potassium polyacrylamide and related compounds to
consolidate or contain wound drainage or debris. In some
embodiments, the fluid trap may include a super absorbent material
placed in an absorptive container, for example, caged so that when
a fluid level rises to the top of the container, the absorbent
material will becomes a gel. In some embodiments, the fluid trap is
transparent to permit viewing into the interior of the trap to
assist the patient in determining the remaining capacity of the
fluid trap and quality of exudates, or to determine the rate of
drainage of the filling of the trap. In some embodiments, the fluid
trap may include a means for sampling the wound exudates to allow
continuous monitoring of the wound status. Prior art describing
means for fluid sampling are described in U.S. Pat. No. 6,890,323,
U.S. Pat. No. 5,125,414 U.S. Pat. No. 6,056,731, US20070060872A1,
US20060189926A1, US20080077096A1, US20080015425A and
US20030073932A1.
[0081] In some embodiments, this invention provides a wound healing
system comprising a dressing for wound containment; [0082] a first
inlet in said dressing, wherein said inlet is operationally
connected to a source for the application of negative pressure;
[0083] a second inlet in said dressing, wherein said second inlet
is located distally to said first inlet, and wherein said second
inlet is operationally connected to a source for the application of
oxygen flow; and [0084] a fluid trap operationally connected to
said first inlet, such that fluid from said wound fluid is conveyed
to said trap, wherein said trap further comprises a detector moiety
which senses a fluid level in said trap and regulates application
of said negative pressure and optionally oxygen flow in response to
achieving a defined fluid level or a change in fluid
characteristics.
[0085] In some embodiments the fluid trap has a sensor for
detection of fluid level and fluid characteristics. In some
embodiments, such sensor may be based on specific gravity,
detecting changes therein over time. In one embodiment, a simple
float having a specific gravity between those of the process fluid
and the headspace vapor will float at the surface, accurately
following its rising and fall. Floats work on the principle of
placing a buoyant object with a specific gravity intermediate
between those of the process fluid and the headspace vapor into the
tank, then attaching a mechanical device to read out its position.
The float sinks to the bottom of the headspace vapor and floats on
top of the process fluid. The float may be connected to a switch
which upon reaching the predetermined level alerts by light and/or
sound and activate a relay for shutting down the negative pressure
source and oxygen flow.
[0086] In some embodiments, the devices and methods of this
invention employ use of a sensor, which detects blood perfusion in
the affected limb.
[0087] In some embodiments, the sensor maybe a hydrostatic device.
Examples of hydrostatic measurement devices are: displacers,
bubblers, and differential-pressure transmitters. Displacers work
on Archimedes' principle. A column of solid material (the
displacer) is suspended in the vessel. The displacer's density is
always greater than that of the process fluid, thus it will sink in
the process fluid, and it must extend from the lowest level
required to at least the highest level to be measured. As the
process fluid level rises, the column displaces a volume of fluid
equal to the column's cross-sectional area multiplied by the
process fluid level on the displacer. A buoyant force equal to this
displaced volume multiplied by the process fluid density pushes
upward on the displacer, reducing the force needed to support it
against the pull of gravity. The transducer, in the form of a
relay, which is linked to the transmitter, monitors and relates
this change in force to level.
[0088] In some embodiments a bubbler-type level sensor maybe used.
A dip tube having its open end near the vessel bottom carries a
purge gas (typically air, although an inert gas such as dry
nitrogen may be used when there is danger of contamination of or an
oxidative reaction with the process fluid) into the tank. As gas
flows down to the dip tube's outlet, the pressure in the tube rises
until it overcomes the hydrostatic pressure produced by the liquid
level at the outlet. That pressure equals the process fluid's
density multiplied by its depth from the end of the dip tube to the
surface and is monitored by a pressure transducer connected to the
tube.
[0089] In some embodiments the sensor may be of a differential
pressure (DP) level sensor. The essential measurement is the
difference between total pressure at the bottom of the tank
(hydrostatic head pressure of the fluid plus static pressure in the
vessel) and the static or head pressure in the vessel. As with the
bubbler, the hydrostatic pressure difference equals the process
fluid density multiplied by the height of fluid in the vessel.
Usually such sensor uses atmospheric pressure as a reference. A
vent at the top keeps the headspace pressure equal to atmospheric
pressure.
[0090] In some embodiments, the fluid sensor may be in the form of
load cells. A load cell or strain gauge device is essentially a
mechanical support member or bracket equipped with one or more
sensors that detect small distortions in the support member. As the
force on the load cell changes, the bracket flexes slightly,
causing output signal changes. Calibrated load cells have been made
with force capacities ranging from fractional ounces to tons. To
measure level, the load cell must be incorporated into the vessel's
support structure. As process fluid fills the vessel, the force on
the load cell increases. Previous knowledge of the vessel's
geometry (specifically, its cross-sectional area) and the fluid's
specific gravity, allows converting the load cell's known output
into the fluid level.
[0091] In some embodiments the fluid level sensor maybe of a
magnetic level gauge. They are similar to float devices, but they
communicate the liquid surface location magnetically. The float,
carrying a set of strong permanent magnets, rides in an auxiliary
column (float chamber) attached to the vessel by means of two
process connections. This column confines the float laterally so
that it is always close to the chamber's side wall. As the float
rides up and down with the fluid level, a magnetized shuttle or bar
graph indication moves with it, showing the position of the float
and thereby providing the level indication. The system can work
only if the auxiliary column and chamber walls are made of
nonmagnetic material.
[0092] Traps, flanges, and process connections can be made from
engineered plastics such as Kynar or exotic alloys such as
Hastelloy C-276. Special trap configurations can handle a variety
of conditions including biological hazard waste which needs to
autoclaved for sterilization. Numerous metals and alloys such as
titanium, Incoloy, and Monel are available for varying combinations
of high-temperature, high-pressure, low-specific-gravity, and
corrosive-fluid applications. Current magnetic level gauges can
also be outfitted with magnetostrictive and guided-wave radar
transmitters to allow the gauge's local indication to be converted
into 4-20 mA outputs that can be sent to a controller or control
system. This conversion maybe beneficial for a relay to be
connected to the source for application of negative pressure and
optionally oxygen flow, controlling its operation.
[0093] In another embodiment, the sensor may be a capacitance
transmitter. These devices operate on the fact that process fluids
generally have dielectric constants, significantly different from
that of air, which is very close to 1. Oils have dielectric
constants from 1.8 to 5. Pure glycol is 37; aqueous solutions are
between 50 and 80. This technology requires a change in capacitance
that varies with the liquid level, created by either an insulated
rod attached to the transmitter and the process fluid, or an
uninsulated rod attached to the transmitter and either the vessel
wall or a reference probe. As the fluid level rises and fills more
of the space between the plates, the overall capacitance rises
proportionately. An electronic circuit called a capacitance bridge
measures the overall capacitance and provides a continuous level
measurement.
[0094] A more advanced method of fluid level measurement, and
representing an embodiment for use in the system and methods of
this invention, is using time-of-flight (TOF) measurements to
transduce the liquid level into a conventional output. These
devices typically operate by measuring the distance between the
liquid level and a reference point at a sensor or transmitter near
the top of the vessel. The systems typically generate a pulse wave
at the reference point, which travels through either the vapor
space or a conductor, reflects off the liquid surface, and returns
to a pickup at the reference point. An electronic timing circuit
measures the, total travel time. Dividing the travel time by twice
the wave's speed gives the distance to the surface of the fluid.
The technologies differ mainly in the kind of pulse used to make
the measurement. Ultrasound, microwaves (radar), and light all have
proven useful.
[0095] In one embodiment, the sensor maybe in the form of a
magnetostrictive level transmitter. In a magnetostrictive system,
the float carries a series of permanent magnets. A sensor wire is
connected to a piezoceramic sensor at the transmitter and a tension
fixture is attached to the opposite end of the sensor tube. The
tube either runs through a hole in the center of the float or is
adjacent to the float outside of a nonmagnetic float chamber. To
locate the float, the transmitter sends a short current pulse down
the sensor wire, setting up a magnetic field along its entire
length. Simultaneously, a timing circuit is triggered ON. The field
interacts immediately with the field generated by the magnets in
the float. The overall effect is that during the brief time the
current flows, a torsional force is produced in the wire, much like
an ultrasonic vibration or wave. This force travels back to the
piezoceramic sensor at a characteristic speed. When the sensor
detects the torsional wave, it produces an electrical signal that
notifies the timing circuit that the wave has arrived and stops the
timing circuit. The timing circuit measures the time interval (TOF)
between the start of the current pulse and the wave's arrival. From
this information, the float's location is very precisely determined
and presented as a level signal by the transmitter. Key advantages
of this technology are that the signal speed is known and constant
with process variables such as temperature and pressure, and the
signal is not affected by foam, beam divergence, or false echoes.
Another benefit is that the only moving part is the float that
rides up and down with the fluid's surface.
[0096] In another embodiment, an ultrasonic level transmitter
sensor may be incorporated in the systems/methods of this
invention. Ultrasonic level sensors measure the distance between
the transducer and the surface using the time required for an
ultrasound pulse to travel from a transducer to the fluid surface
and back (TOF).
[0097] In one embodiment the sensor can be part of a laser level
transmitter. Designed for bulk solids, slurries, and opaque liquids
such as dirty sumps, milk, wound and blood fluids, and liquid
styrene, lasers operate on a principle very similar to that of
ultrasonic level sensors. Instead of using the speed of sound to
find the level, however, they use the speed of light. A laser
transmitter at the top of a vessel fires a short pulse of light
down to the process liquid surface, which reflects it back to the
detector. A timing circuit measures the elapsed time (TOF) and
calculates the distance. The key is that lasers have virtually no
beam spread (0.2.degree. beam divergence) and no false echoes.
Lasers are precise, even in vapor and foam. They are ideal for use
in vessels with numerous obstructions and can measure distances up
to 1500 ft.
[0098] Another sensor type which may be incorporated in the
systems/methods of this invention is the radar level transmitter.
Through-air radar systems beam microwaves downward from either a
horn or a rod antenna at the top of a vessel. The signal reflects
off the fluid surface back to the antenna, and a timing circuit
calculates the distance to the fluid level by measuring the
round-trip time (TOF). In guided wave radar (GWR) systems a rigid
probe or flexible cable antenna system guides the microwave down
from the top of the tank to the liquid level and back to the
transmitter. As with through-air radar, a change from a lower to a
higher causes the reflection. Guided wave radar is 20 more
efficient than through-air radar because the guide provides a more
focused energy path. Moreover, these systems can be installed
either vertically, or in some cases horizontally with the guide
being bent up to 90.degree. or angled, and provide a clear
measurement signal. GWR exhibits most of the advantages and few of
the liabilities of ultrasound, laser, and open-air radar systems.
Radar's wave speed is largely unaffected by vapor space gas
composition, temperature, or pressure. It works in a vacuum with no
recalibration needed, and can measure through most foam layers.
Confining the wave to follow a probe or cable eliminates
beam-spread problems and false echoes from tank walls and
structures.
[0099] In another embodiment, the fluid trap may be connected to a
sensor which employs photometric or optical methods for detecting
the presence of blood in wound fluid being drawn away from the
wound by the negative pressure device. In some embodiments, LEDs in
the 540/560/580/620/640/660 nm and 800 nm ranges are used as the
emitters and a photo detector sensitive to the same range of
wavelengths is used as the receptor. These solid state optical
components are positioned across a flow stream of the wound fluid
and measurements are taken of the absorption of the illuminating
light in a manner that specifically identifies and quantifies the
presence of blood in the fluid. Variations in the system include
different structures to hold or contain the wound fluid while
optical measurements are being made as well as different placements
of the detection site. One objective common to each implementation
of the various previous embodiments dealing with fluid sensing is
to allow for either the activation of a caregiver or patient
notification signal and/or the automatic modification or cessation
of the OPT. In either case the detection system of the present
invention is capable of providing a digital output signal suitable
for triggering any of a number of different caregiver/patient
notification signaling devices or suitable for modifying the OPT
operation. A notification signal would be associated with the
identification of a wound fluid blood content that exceeded a
pre-set level (>30% as an example) indicative of an abnormal
condition (excessive bleeding) in the wound. Different types of
wounds would merit different settings in this regard as would
differing stages of wound healing.
[0100] Alternately, in one embodiment, the detection system could
generate a staged signal that provided more refined "instructions"
to the OPT system being implemented. For example, a given wound
fluid blood concentration level could trigger a reduction in the
negative pressure level of the therapy without altogether ceasing
the therapy. A greater concentration or a sudden change in
concentration could instead trigger the cessation of the therapy in
conjunction with a notification signal. Because there potentially
exists a variety of OPT regimens, a variety of modifications to
these regimens, as triggered by wound fluid blood concentration
levels, are anticipated. The low voltage/low current connections to
a microprocessor may be structured with anything from a simple
electrical conductor bundle connected to a power source same as the
negative pressure source. In the alternative, the low power
electronics (LEDs and photo detector) of the device could be
locally powered (as by an onboard battery) and a wireless signal
communication could be structured between the detector device
(acting essentially as a remote blood sensor) and the signal
processing instrumentation containing the microprocessor which
controls the application of negative pressure.
[0101] As a further alternate application of the system of the
present invention, color responsive chemical sensors (Elisa or
non-layered biosensors, for example) may be incorporated in any of
the sensing methods described to monitor chemical species in the
wound fluid. Such species might include cytokines, creatinine,
urea, among other chemicals of interest to those clinicians guiding
the normal healing process of the wound.
[0102] In some embodiments, the negative pressure system includes
an internal self contained battery source, a pressure sensor or
transducer to monitor pressure within the wound dressing, and
self-contained regulation or control means. In some embodiments,
the pressure sensor is disposed within the interior of the wound
dressing and is in electrical connection with the control means
through an electrical wiring. An example, in one embodiment, of a
suitable pressure sensor is the Dynamic ICP Pressure Sensor of the
Pressure Division of PCB Piezotronics, Inc. The pressure sensor
would also provide information to assist in detecting a leak in the
wound dressing. In some embodiments, the control means is
incorporated within the pump housing of the pump. In some
embodiments, the control means may incorporate a motor
controller/driver including processing and drive software or
circuitry to control or vary the drive voltage to the motor of the
pump responsive to the pressure sensed by the pressure sensor
and/or other operational parameters including operational time
constraints etc. For example, in one embodiment, the motor
controller/driver may be programmed to run only for a predetermined
period of time after start-up. The output of the pump motor may be
increased or decreased, or initiated or discontinued, as controlled
by the control means. In some embodiments, the regulation or
control means may also have an alarm such as a visual, audio or
tactile sensory alarm (e.g., vibratory etc.) to indicate when
specific conditions have been met (e.g., the desired negative
pressure level, loss of negative pressure or leak). In some
embodiments, an override switch may also be incorporated within the
pump system to allow optionally for the initiation or termination
of the operation of the pump as desired without input from the
control means. In one embodiment, wireless means are also
envisioned to operate the pump through the control means. In some
embodiments, a regulator will be utilized, which specifically
synchronizes between the oxygen supply to the wound site and the
application of the vacuum. Fluids are drawn away from the wound bed
and into the contact layer of the wound dressing. These fluids
and/or exudates are removed from the contact layer under the
negative pressure of the pump. The fluids are delivered through the
inlet and outlet tubing to be collected within the fluid trap. In
one embodiment, once the desired level of sub atmospheric pressure
is achieved as detected by, e.g., a pressure sensor, the pressure
sensor sends a signal to the control means. In one embodiment, the
control means may either terminate operation of the pump or
alternatively vary the speed or output (e.g., decrease) of the
pump. In this negative pressure state, wound fluid and exudates are
continually drawn into the contact layer. After a period of time,
the wound dressing may lose its vacuum state as detected by the
pressure sensor or detected visually. When the loss of a desired
vacuum level is achieved, the pressure sensor sends a signal to the
control means to activate or increase the output of the pump. The
negative pressure source removes the fluid from the contact layer
and reestablishes the vacuum state within the wound dressing. In
one embodiment, the dressing is comprised from segments which allow
the application of negative pressure to each one of the segments
without affecting nearby segment. An advantage of such kind of
method is that it facilitate the application of negative pressures
against a patient's limb and in so doing promote venous return.
This is important both in wound healing and in the prevention of
deep venous thrombosis (DVT) which sometimes occurs in surgical
patients when they are confined to bed. When a DVT occurs, the
valves that are located within the veins of the limb can be damaged
which in turn can cause stasis and high pressure in the veins.
Patients who have this condition often have limb swelling (edema)
and tissue breakdown (venous stasis ulcer) in the limb. In one
embodiment, for example, the system delivers negative pressure
through the tubing sets to a pair of segments on the dressing and
after a predetermined time relieves the pressure and applies
negative pressure to different segments. In some embodiments, the
negative pressure system independently compresses one or more, of
the segments. Negative pressure may alternate between the segments
on the dressing resulting in a predetermined sequential order for
the application of negative pressure in a way that in some
embodiments, increases venous blood return and lymph flow. It is
understood that wound healing system can detect any combination of
garments and number of segments therein connected to one or more
ports. As indicated hereinabove, in the alternative, the negative
pressure source may be initiated via the manual override switch
when for e.g., that the fluid trap is seen to be full. In one
embodiment; the source for the application of negative pressure
maybe portable, battery operated and carried by the patient, which
permits patient mobility.
[0103] In addition to applying a negative pressure the methods and
system of this invention rely on the application of high oxygen
partial pressure to the wound. In some embodiments, the oxygen
source is tethered to a separate inlet positioned distally to the
negative pressure inlets on the wound dressing and maybe portable
as well. Oxygen from a suitable source such as a pressurized tank
of oxygen or an in-line/wall socket is supplied to the dressing end
via an oxygen feed line/tubing connected to a filter which is
connected to an oxygen inlet in the dressing. In some embodiments,
the tubing may be any suitable flexible tubing fabricated from
elastomeric and/or polymeric materials. It may vary in size and
shape as required for treatment of the wound. In some embodiments,
the inlet maybe embedded within the dressing or attached by an
adhesive to an opening in the dressing. In some embodiments, the
inlet is comprised of a polymeric, oxygen non-reactive material
suitable to withstand the pressure from the oxygen source. In some
embodiments, a pressure reducing valve, manually/automatically
controllable to adjust the pressure of oxygen and/or the flow of
oxygen fed to the tube is disposed in the line. In some
embodiments, a manually controlled on-off valve is connected in the
line between the tank and the pressure reducing valve. In use, in
one embodiment, for example the oxygen valve is opened, and the
valve is adjusted until the needed oxygen flow is achieved. In one
embodiment, continues or interrupted oxygen flow may be used in the
healing process of the wound. Oxygen concentration at the range of
21 to 100 percent is administered to the wound at a rate of 0.25-25
L/min depending on the wound size and/or the source of the vacuum.
Detection of oxygen concentration, allowing real-time adjustment of
oxygen at the vicinity of the wound, can be done, in some
embodiments, by using an oxygen sensor. In one embodiment, an
example of an oxygen sensor is Nellcor.TM. oximax sensors.TM.. In
some embodiments, an automatic controlled valve is connected in the
line between the tank and the pressure reducing valve. The
automatic valve may be connected, in some embodiments, to a relay
which is responsive to the amount of oxygen inside the dressing. In
one embodiment, the relay receives oxygen concentration
measurements from an oxygen sensor embedded in the wound dressing.
In one embodiment, the relay serves as controller for oxygen levels
within the dressing by adjusting the flow of oxygen through the
automatic valve. In some embodiments, synchronization between
oxygen flow and actual vacuum in the wound is controlled by
computerized predetermined control system.
[0104] In some embodiments, other potentially healing beneficial
gases such as ozone maybe administered at a concentration ranging
from 10 microgram/ml (0.21 micromol/ml) up to 80 microgram/ml (1.68
micromol/ml) in the patient blood. In some embodiments, the other
beneficial gases maybe administered instead or in parallel to
oxygen through the oxygen inlet by replacing the oxygen source with
a different gas source. In some embodiments, other various gases
available in the atmosphere, in different concentrations, may be
used in treatment of the wound.
[0105] In one embodiment, the wound healing system includes an
electric and or mechanical synchronizing control means to regulate
simultaneous or consecutive application of vacuum and oxygen. Prior
art describing regulated gas flow control are described in patents
U.S. Pat. No. 4,651,729, U.S. Pat. No. 6,173,735, EP1396774B1,
US20040099270A1, U.S. Pat. No. 6,647,982, U.S. Pat. No. 6,189,531.
This control system receives signals from the pressure sensor and
the oxygen sensor and regulates the flow of oxygen in accordance to
conditions determined by the treatment administrator. This control
allows monitoring, regulation and setting the concentration of
oxygen in the wound. For example, oxygen should be regulated in
parallel to the application of negative pressure to avoid over
inflating the wound dressing with oxygen which may result in the
concomitant separation of the covering top layer and loss of
vacuum.
[0106] In some embodiments, both the negative pressure pump and the
oxygen tank maybe of a portable type where the patient does not
need to be constrained for any period of time during therapy and
while exudates are being removed from the wound.
[0107] Referring now to FIG. 1, the wound dressing system in
accordance with an embodiment of the present disclosure is
illustrated herein. The wound dressing system includes a composite
wound dressing 1-20, comprising an absorptive layer and a fluid
impermeable layer, a negative pressure source (1-40) connected to
the wound dressing by an inlet and tubing 1-30 and an oxygen source
(1-60) connected to the wound dressing by an inlet and tubing 1-70,
which source may additionally comprise a valve and regulator
(1-50), an outflow controller (1-80), etc. to allow for regulated
flow. This system allows the application of negative pressure in
parallel to an inflow of oxygen. Moreover, in some embodiments, the
oxygen inflow and negative pressure maybe constant, intermittent or
independent one from the other. In one embodiment, a fluid trap
1-90 is operationally connected to a drainage source or tubing
conveying fluid from the wound via the negative pressure inlet 1-30
to the negative pressure source 1-40 in order to collect fluids
drown from the wound. The dressing 1-20 may comprise a first layer,
which may also be referred to as the mold (1-10), and a covering
drape (1-15), which may be adhered to the mold, or placed over the
mold to form the dressing.
[0108] In FIG. 2A, one embodiment of a cross section of the
dressing is shown where inlets for application of negative pressure
and oxygen (2-10 and 2-20 respectively) are positioned distally
with relation of one to another. It is to be understood that the
dressing may comprise multiple inlets for introduction of oxygen,
as shown in the figure, and/or for applying negative pressure, and
any such arrangement is to be considered as part of this
invention.
[0109] FIG. 2B depicts another embodiment of a device/method of
this invention, where multiple dressings, as shown here for
example, three dressings (2-60, 2-70 and 2-80, respectively) may be
infused with oxygen and negative pressure is applied to each
dressing, wherein a single oxygen source (2-40) and source of
negative pressure (2-30) is utilized for each of a series of
dressings. In this embodiment, tubing (2-50) connects the
respective dressings to the oxygen source, or the tubing (2-90)
connects the respective dressings to a source of negative
pressure.
[0110] FIG. 2C depicts an embodiment of a material used to convey
oxygen to the sound site or for the application of negative
pressure. For such purpose, any tubing may be used, as described
herein. In some embodiments, the tubing will comprise a sponge
(2-100) surrounded by an air-tight drape (2-110), which tubing is
flexible and unlikely to cause inflammation or discomfort when used
on subjects for whom application of the devices and methods of this
invention is desired.
[0111] In FIG. 3, one embodiment of the of the dressing is shown
with multiple inlets (3-10, 3-20, 3-30) for the application of
negative pressure via the operational connection of the inlets to
the source of negative pressure (3-90). The inlets are inserted in
segments of the dressing, which are separated one of the other by a
gas and fluid impermeable barrier (3-50, 3-60). An oxygen inlet
(3-80) is positioned distally to said multiple inlets (3-10, 3-20,
3-30) and within the compartment containing an open wound. The
remaining compartments proximal to said wound-containing
compartment allow for the controlled application of negative
pressure, which pressure is less than the blood pressure detected
within the wound-containing limb. Such pressure may be alternating
or concurrent with application of negative pressure to the
wound-containing compartment and allows promotion of healing of the
wound.
[0112] FIG. 4(A-C) depicts an embodiment of a fluid-trap which can
be used with the system of this invention. FIG. 4A depicts an
embodiment of a cap for a fluid trap for use with the systems of
this invention, containing multiple parts. A buoy 4-60 is contained
within a net 4-70, serving as an indicator of fluid height within
the trap. In some embodiments, a sensor relay system detects
raising of the buoy and relays a signal to a controller regulating
the application of negative pressure, which halts application of
the negative pressure to the dressing. The trap system may comprise
a secondary buoy 4-40, which is similarly contained within a bottle
cover bottom 4-50, which in turn serves as a primary indicator of
fluid height, which may be operationally connected to a sensor
relay system as described above. A filter 4-30 may be positioned
above the bottle cover bottom to prevent contamination of the
source of negative pressure, which filter is positioned below the
bottle net 4-20 placed immediately under the bottle cap 4-10,
forming a closed system. A silicone hat 4-80 may be used to ensure
appropriate positioning of the bottle cap parts within the cap.
[0113] This invention further provides a method for treatment of
wounds comprising a dressing for wound containment which allows the
application of negative pressure to the wounded area and the
concurrent or temporal application of oxygen to the wound. Examples
of wounds that require such treatment are crush injuries,
lacerations, burns, infected wounds or a diabetes-associated wound
complication. In some embodiments, during the treatment for the
wound, skin grafts or flaps may be required for the process of
healing. In some embodiments, application of the dressing on the
wounded area after skin graft would be beneficial for the healing
process. In some embodiments the dressing may comprise of several
layers which are placed on top of the wound to accommodate the
surface of the wounded area. In some embodiments, the dressing is
comprised from a sponge that allows the absorption of the wound
exudates and the application of negative pressure which support the
removal of wound fluids and contamination from the wounded area. In
some embodiments, whether the dressing is comprised of bandages or
sponges, the composition of the dressing material is compressible
to allow the application of pressure to secure skin graft to its
place. In some embodiments, the sponge is a combined layer sponge,
where the first layer proximal to the wound is absorptive and the
second layer distal to the wound is gas and fluid impermeable.
Furthermore, the dressing material is elastic to allow covering of
the wounded area. In some embodiments, application of negative
pressure requires the addition of an impermeable outer layer on top
of the absorbent layers of the dressing to accommodate a tight
occlusion around the wounded area. In this method the therapeutic
application of negative pressure is done by connecting the dressing
to a negative pressure source. In some embodiments, this connection
is done through an inlet in the dressing. In some embodiments of
this method, the negative pressure is applied to sections of the
dressing, where these sections are separated by a gas and fluid
impermeable barrier within the dressing. This allows the
application of negative pressure to parts of the wound as directed
by the treatment administer. Negative pressure promotes the healing
of wound through multiple pathways including removal of excess
fluids from the wound, increased blood circulation at the site of
the wound, decreasing the bacterial load on the wound, increasing
growth factors and increasing white blood cells and fibroblast at
the site of the wound. In some embodiments, negative pressure is
applied to the wound through the dressing at a range of 20 mmHg to
500 mmHg. In some embodiments, the negative pressure would be
higher than 200 mmHg, for short periods of time, in order to
facilitate fast and efficient removal of toxic fluids or materials
from the wound. In some embodiments, the negative pressure and/or
oxygen flow is adjustable using a regulator and/or synchronizing
system, thus enabling the determination of the amount of negative
pressure and/or pO.sub.2 at the site of the wound. In some
embodiments, a pressure sensor inside the wound dressing indicates
the negative pressure's induced static pressure on the wound or
limb that may interfere or obstruct blood flow distally, allowing
the adjustment to be made by using said regulator. In some
embodiments, a fluid trap is disposed "in-line" between the
negative pressure source and the dressing. The fluid trap retains
wound fluids draw from the wound by the application of negative
pressure. In some embodiments a sensor is built into the trap for
detection of fluid levels and fluid composition. During the
treatment the sensor, in some embodiments, indicates when the fluid
trap is full and operates a relay for shutting down the negative
pressure source and oxygen flow. In some embodiments, the sensor
may also monitor excess blood in the wound fluids by monitoring
fluid composition. When excess blood (over a predetermined
threshold) is detected the sensor, for example, through a relay,
for example as described in U.S. Pat. No. 5,411,269 shuts down the
negative pressure source and alerts the care givers by and
indicative light and/or sound.
[0114] In treatment of wounds due to infection of anaerobic
bacteria application of oxygen to the wounded site in parallel to
negative pressure has an advantage in creating an oxygenated
environment that restricts or may terminate the growth and
proliferation of anaerobe bacteria.
[0115] In some embodiments, this invention is aimed at treating
wounds resulting from crush injuries, lacerations, burns,
infections and diabetes-associated complications, and the like.
[0116] In one embodiment, this invention provides a method of
treating a wound in a subject, said method comprising the steps of
applying a source of oxygen containing to a wound in said subject
and concurrently applying negative pressure to said wound, wherein
said source of oxygen maintains oxygen at a value of at least 21%
of the total gas in said source and whereby application of oxygen
and negative pressure to said wound stimulates wound healing.
[0117] In one embodiment, this invention provides a method of
treating or preventing anaerobic infection of a wound in a subject,
said method comprising the steps of applying a source of oxygen
containing to a wound in said subject and concurrently applying
negative pressure to said wound, wherein said source of oxygen
maintains oxygen at a value of at least 21% of the total gas in
said source and whereby application of oxygen and negative pressure
to said wound treats or prevents anaerobic infection of said
wound.
[0118] In some embodiments, the methods of this invention make use
of the devices as herein described. In some embodiments, the
methods of this invention may comprise administering a therapeutic
agent to the subject prior to, concurrent with or following the
carrying out of the described elements of the methods of this
invention, as herein described.
[0119] In some embodiments, therapeutic medicaments are
administered in parallel to effecting the methods of this
invention, i.e. wound treatment with combined negative pressure and
oxygen application. This is done, in one embodiment, by
administering these medicaments to the patient or by applying the
medicaments onto the dressing of the wound. The medicaments, in
some embodiments, may include, but are not limited to, antiseptics,
antibiotics, enzymes, analgesic drugs and anti-inflammatory drugs.
Administration of wound medicaments of the invention can include
local or systemic administration, including injection, oral
administration, or catheterized administration, and topical
administration. For treatment of wounds on the surface of the body,
a wound healing composition is typically prepared in a topical
form, either as a liquid solution, suspension, gel, cream or
chemically attached to the dressing to be slowly released to the
wound. However, solid forms suitable for solution or suspension in
liquid vehicles prior to injection can also be prepared, for local
treatment of deep wounds or by continuous or intermittent
catheterized administration of medicaments into deep wounds or
cavities (as for treatment of infected pacemakers or other
indwelling devices). Both the dose of a particular wound healing
composition and the means of administering the composition can be
determined based on specific qualities of the wound healing
composition, the condition, age, and weight of the patient, the
type and extent of the wound being treated, the device being
treated and other relevant factors. In some embodiments, wound
healing medicaments can comprise a pharmaceutically acceptable
carrier. Pharmaceutically acceptable carriers are well known to
those in the art. Such carriers include, but are not limited to,
large, slowly metabolized macromolecules, such as proteins,
polysaccharides, polylactic acids, polyglycolic acids, polymeric
amino acids, amino acid copolymers, and inactive virus particles.
In one embodiment, parallel application of negative pressure
through an inlet in the dressing and inflow of oxygen through
another distal inlet results in a synergistic outcome of faster
healing. In some embodiments, intermitted application of oxygen or
negative pressure or both may result in better healing of the
infected wound.
[0120] Referring now to FIGS. 5, 6, 7 where application of a
makeshift device similar in principle of operation to that
described in FIG. 1 for treatment of wounds are shown. In FIG. 5, a
49-year-old male, suffering from sepsis and necrotizing fasciitis
is treated with regulated oxygen-negative pressure therapy
(RO-NPT). This patient required mechanical ventilation; therefore
the placement of the patient in a hyperbaric oxygen chamber was not
possible. FIG. 5B presents a photograph of one embodiment of the
makeshift system used in treating the wound. Once the patient was
exposed to RO-NPT therapy, the wounds began healing. FIG. 5C
presents a photograph showing extinction of infection and
resolution of the wound which occurred within a period of 4 weeks.
In FIG. 6, a 66-year-old diabetic female presented with severe
signs of sepsis and necrotizing fasciitis due to complications of
diabetes. Photographs of the wounds prior to treatment are
presented in FIG. 6A showing necrotizing fasciitis in the deep
tissue along the fascia involving the right inguinal region, the
medial and lateral thigh and along the medial aspect of the right
lower limb down to the ankle. FIG. 6B presents a photograph of one
embodiment of the makeshift system for RO-NPT treatment. After
treatment substantial improvement was achieved as shown in FIG. 6C.
FIG. 7 shows a 36-year-old male sustained a crash and deep burn
injury of the Lt. fore-arm and elbow, presented with deep 2nd-3rd
degree burns. Photographs of the wounds prior to treatment are
presented in FIG. 7A. FIG. 7B presents a photograph of one
embodiment of the makeshift system used to treat the patient. Upon
RO-NPT treatment and skin grafts substantial improvement was
achieved as shown in FIG. 7C.
[0121] Necrotizing soft-tissue infection is a severe type of tissue
infection that can involve the skin, subcutaneous fat, the muscle
sheath (fascia), and the muscle. It can cause gangrene, tissue
death, systemic disease and death. Powerful, broad-spectrum
antibiotics must be given immediately through a vein (IV) in an
attempt to control the infection by quickly raising the blood
levels of the antibiotic. Surgery is required to open and drain
infected areas and remove dead tissue. Skin grafts may be required
after the infection is cleared. If the infection is in a limb and
cannot be contained or controlled, amputation of the limb is a
typical outcome. If the organism is determined to be an
oxygen-avoiding bacterium (anaerobe), the patient may be placed in
a hyperbaric oxygen chamber, a device in which the patient is given
100% oxygen at several atmospheres of pressure. The outcomes are
variable. The type of infecting organism, rate of spread,
susceptibility to antibiotics, patient's general health condition,
the availability of treatment facilities (as hyperbaric chamber)
and the timing of diagnosis all contribute to the final outcome.
Scarring and deformity are common with this type of disease.
Fatalities are high even with aggressive treatment and powerful
antibiotics. Untreated, the infection invariably spreads and causes
death. It would be contraindicated to seal NF wounds, and preclude
access of air to the wound site, which is precisely what occurs in
RNPT treatment of NF wounds that even actively reduce pO.sub.2 in
the wound atmosphere. The methods/devices/systems of this invention
uniquely offer a clear advantage for the treatment of such
wounds.
[0122] In some embodiments, the invention provides methods for
treating wounds using the devices and systems of this
invention.
[0123] In some embodiments, such methods comprise placing a wound
in subject within a wound healing system or device of this
invention, applying negative pressure to the wound via the devices
and/or systems of the invention and concurrently or temporally
applying oxygen to the devices and/or systems of the invention,
whereby simultaneous application of oxygen and negative pressure to
the wound stimulates wound healing.
[0124] In some embodiments of the invention, according to this
aspect, treatment may further comprise making use of a system
including any embodiment listed herein. In some embodiments, such
systems may comprise a dressing comprised of a first layer, which
is gas and fluid permeable having a plurality of discrete oxygen
passageways overlying the wound and through which negative pressure
established by the negative pressure source is communicated to the
wound. In some embodiments, the method may further comprise
administering an antiseptic, antibiotic, analgesic, or an
anti-inflammatory medicament to said subject, or in some
embodiments, the method may make use of a dressing, which
incorporates an antiseptic, antibiotic, analgesic, or an
anti-inflammatory medicament.
[0125] In some embodiments, the wound treated by the methods of
this invention or treated with the systems and/or devices of this
invention is a result of a trauma (burn, laceration), an infection,
PVD or a diabetes-associated complication.
[0126] In some embodiments, the infection is caused by an anaerobic
or facultative anaerobic organism. In some embodiments, treatments
of this invention may include treatment of infection with
Clostridium, Actinomyces, Streptococcus, Staphylococcus,
Escherichia, Bacteriodes, Peptococcus, Fusobacterium, Arachnia,
Eubacterium, Bifidobacterium, Lactobacillus, Propionibacterium,
Peptostreptococcus, Veillonella, Acidominococcus, Pseudomonas,
Prevotella, Porphyromonas, Gemella, Bacillus and others.
[0127] Anaerobes are the predominant fraction of normal human skin
and mucous bacterial flora, and are consequently a common cause of
endogenous infection. In situations such as trauma, vascular
occlusion or surgical manifestations when oxygen concentration is
reduced in tissue, indigenous anaerobic flora multiply quickly and
often result in aggressive infection and sepsis.
[0128] Biofilms appear to be more abundant in chronic wounds, with
diverse polymicrobial communities including strictly anaerobic
bacteria being common in wound sites. Moreover, in wound sites
comprising mixed infections, the presence of aerobic or facultative
aerobes provides a habitat which supports growth of anaerobes by
reducing the oxygen concentration in the infected tissue. This fact
may even be of higher significance in the sealed environment of
RNPT, or when systems are sealed but negative pressure is not
properly applied. RNPT is therefore contraindicated in frank
anaerobic infections or when growth of anaerobic infection is
suspected.
[0129] The methods/devices and systems of this invention are
particularly useful for treatment of wounds infected with anaerobic
organisms. The current recommended treatment for anaerobic
infection, for example, in necrotizing fasciitis includes the
immediate administration of wide spectrum antibiotics, urgent,
aggressive, frequent, surgical intervention and supplementation of
high local and systemic levels of oxygen as in hyperbaric oxygen
treatment (HBO). The global availability of HBO facilities is
limited, its costs are high and treatment may be restricted in
various clinical conditions (for example, in non-ambulatory patient
care).
[0130] RO-NPT is a cost-effective treatment applying readily
accessible technologies that can be used for the treatment of
various wounds, such as necrotizing fasciitis, acute trauma,
diabetic and PVD affected feet and for complicated acute and
chronic wounds. RO-NPT can be employed either in a hospital or as a
home care treatment, and can be utilized on a large scale under
disaster conditions, field settings and other scenarios where
surgical and other therapeutic conditions may not be readily
available or feasible.
[0131] The devices/systems of this invention may be applied to
therapy of most wounds, and is useful, in some embodiments, in
particular for the treatment of soft tissue and bone
infections.
[0132] While various embodiments of the present invention have been
presented, it is possible to use various alternatives,
modifications and equivalents. It is to be understood that any
feature described herein, may be combined with any other feature
described herein. It is to be understood that the article "a", or
"an" refers to a quantity of one or more of the item following the
article, except where expressly stated otherwise.
[0133] The following examples are intended to illustrate but not
limit the present invention.
EXAMPLES
Example 1
Application of Henry's Law
[0134] The partial pressure of a gas in a mixture of ideal gases is
defined as the pressure which the gas would have if it alone
occupied the volume. The total pressure of a gas mixture is the sum
of the partial pressures of each individual gas in the mixture. The
partial pressure of a gas dissolved in a liquid is the partial
pressure of that gas which would be generated in a gas phase in
equilibrium with the liquid at the same temperature. The partial
pressure of a gas is a measure of thermodynamic activity of the
gas's molecules. Gases will always flow from a region of higher
partial pressure to one of lower pressure; the larger this
difference, the faster the flow. Gases dissolve, diffuse, and react
according to their partial pressures, and not necessarily according
to their concentrations in a gas mixture.
[0135] The solubility of a gas in a liquid solution is affected by
temperature and by the partial pressure of that gas over the liquid
as was formulated by William Henry in the early 17th century. In
Henry's law; the solubility of a given gas dissolved in a given
type and volume of a liquid, at a constant temperature, is directly
proportional to the partial pressure of that gas, in the overlying
atmosphere, in equilibrium with that liquid. And when applied to
the solubility of Oxygen in water:
pO.sub.2.dbd.KO.sub.2XO.sub.2
where pO.sub.2 is the partial pressure of oxygen in Torr, XO.sub.2
is the mole fraction of oxygen in oxygen-saturated water, and
KO.sub.2 is the equilibrium constant for oxygen in water (about
3.30 10.sup.7 K/Torr when gas is dissolved in water at 298 Kelvin).
High humidity lowers very slightly the fraction of oxygen in the
air, and so, saturated dissolved oxygen levels are lowered
slightly. Many empirical equations are available to accurately
estimate oxygen solubility as a function of temperature, pressure,
and humidity. The more accuracy required the more complex the
equations.
[0136] Based on Henry's Law, lower air pressure, as found in the
air atmosphere of wounds treated with regulated negative
pressure-assisted wound therapy (RNPT) necessarily result in lower
pO.sub.2 levels in the wound site. Thus, the fluid within the wound
treated with RNPT, according to Henry's law would necessarily
contain less dissolved oxygen than untreated wounds. In the closed,
moist milieu of a vacuum treated wound, when the wound is already
contaminated, an ideal microenvironment for anaerobes then arises,
owing to the diminished pO.sub.2. This provides an optimal
environment for the development of anaerobic infections.
Example 2
[0137] Application of an Embodied Device of this Invention
[0138] An in-vitro model was designed, to assess oxygen behavior in
a simulated wound atmosphere. An experimental setup was planed to
determine the spectrum levels of oxygen partial pressures in the
environment of wounds treated with RNPT and RNPT simultaneously
enriched with oxygen under various oxygen flow conditions and
varied application of negative pressure.
[0139] The system utilized is depicted in FIG. 8. The system
combines application of a regulated oxygen-enriched atmosphere with
RNPT. A phantom leg was circumferentially draped with Polyvinyl
chloride (IUPAC Polychloroethene) foam and was sealed under a drape
covering the entire treated area. The system affords a relatively
large volume cavity, necessitating a high flow vacuum pump to
accommodate the cavity volume and the high inflow volume of oxygen,
easily achieved by connecting the apparatus to a wall suction
outlet as a sub atmospheric source.
[0140] Negative pressure was applied to the system via use of a
Healer .alpha. (iLSino Ltd. Taiyuan, PRC) operating in external sub
atmospheric source mode set to levels typically applied in clinical
cases (in the range of 50-200 mmHg in 25-50 mmHg increments).
Oxygen flow was controlled and delivered to the simulated wound by
an oxygen regulator (Silbermann Technologies Ltd. Petah-Tikva,
Israel) through a micro filter in predetermined 1 liter per minute
flow increments in a range of 1 to 10 liters per minute. 100%
medical oxygen was administered to the counter edge of the vacuum
source so that oxygen flow was homogenously distributed through the
sponge cavities, in contact with the wound, over the entire wound
surface area and was sealed by a drape. Pressure was readjusted
following the administration of oxygen to the system. pO.sub.2 in
the wound atmosphere was continuously monitored by a pO.sub.2
detector (Teledyme Electronic Devices, City of Industry California,
USA). Calibration was performed at room atmosphere and 100%
pO.sub.2 prior to initiation of each of the experimental set. The
probe was positioned at the outflow suction port and pO.sub.2 was
recorded after equilibration was reached. Considering the internal
pO.sub.2 sensor chamber structure, limited ventilation of the
sensor was expected especially in the low oxygen flow range thus,
the detected levels of pO.sub.2 represent a minimum in terms of the
actual levels of oxygen present in the system.
[0141] PO.sub.2 values were recorded in relative percent units
following calibration of the sensor detecting the oxygen
concentration under atmospheric conditions and in an environment of
100% oxygen, at sea level pressure. pO.sub.2 concentration in an
environment subjected to RNPT decreased to values below the 21%
atmospheric pO.sub.2 level (FIG. 9). A reverse correlation with sub
atmospheric pressure applied to the simulated wound was seen, such
that PO.sub.2 reached its minimum value (down to 14 mmHg) at the
highest RNPT pressure setting evaluated (200 mmHg).
[0142] In marked contrast, simultaneous administration of oxygen
and negative pressure, afforded by the RO-NPT devices of this
invention increased pO.sub.2 concentration at the simulated wound
site (FIG. 10), with applied sub atmospheric pressure correlating
with oxygen flow. pO.sub.2 values reached a maximum value close to
80% under relatively low sub atmospheric pressure (50 mmHg) under
high Oxygen flow (10 liters/min), representing an up to four-fold
increase over baseline [no-oxygen inflow, and sub atmospheric
pressure state].
[0143] The solubility of oxygen in fluid solutions is roughly
proportional to the partial pressure of oxygen in the surrounding
atmosphere. In low air pressures as in the air atmosphere of wounds
treated with RNPT, pO.sub.2 is expected to be lower than 21%,
meaning lower solubility of oxygen in the wound fluids. In this
Example, pO.sub.2 measurements in a simulated wound atmosphere
without supplemental oxygen were in the range of 18-14 mmHg for sub
atmospheric pressures of 50-200, respectively, indicating that the
higher the sub atmospheric pressure applied, the lower the pO.sub.2
concentration at the wound site, rendering the wound site more
susceptible for infection, in particular with anaerobic flora.
[0144] Increasing wound atmospheric pO.sub.2 would lead to
increased oxygen solubility in the wound's fluid thus reducing or
eliminating the chance for anaerobic infections.
Example 3
[0145] Peripheral arterial disease (PAD) causing arterial
insufficiency is the most important factor relating to the outcome
of a diabetic foot ulcer. The prevalence of PAD in people with
diabetes is probably high, and ranges from 10% to 40% depending on
the definition used; in patients with foot ulcers approximately 50%
have signs of PAD.
[0146] Critical ischemia indicates risk of amputation of a major
part of the limb. Chronic critical ischemia is currently defined by
either of the two following criteria: persistent ischemic rest pain
requiring regular analgesia for more than two weeks; ulceration or
gangrene of the foot or toes--both associated with an ankle
systolic pressure of <50 mmHg or a toe systolic pressure of
<30-50 mmHg. The most widely used method for the diagnosis and
quantification of PAD is the measurement of ankle pressure.
[0147] The external application of a vacuum dressing in such
patients, however, may cause perfusion impairment of the distal
limbs due to the pressure from the dressing garment.
[0148] When the peripheral blood pressure within the limb is lower
then the internal pressure generated by the applied vacuum on the
circumferential sponge dressing, it can worsen the ischemic
condition and induce necrosis. FIG. 11 demonstrates the effect of
external vacuum pressure applied to a circumferential dressing
inducing an internal pressure similar to that of a blood pressure
cuff surrounding a limb. If the internal pressure generated by the
dressing exceeds the systolic pressure of the limb, ischemia and
necrosis may be induced. FIG. 11 demonstrates that in clinical
application of RO-NPT (with adjustments to oxygen flow) a maximal
negative pressure that may be applied to ischemic limb treated with
these modalities, may be arrived at, for optimal treatment. When
oxygen is applied to the wound, then internal pressure is then
reduced.
[0149] While the disclosure has been illustrated and described, it
is not intended to be limited to the details shown, since various
modifications and substitutions can be made without departing in
any way from the spirit of the present disclosure. As such, further
modifications and equivalents of the invention herein disclosed can
occur to persons skilled in the art using no more than routine
experimentation, and all such modifications and equivalents are
believed to be within the spirit and scope of the disclosure as
defined by the following claims.
* * * * *