Danielle ZUROVCIK -- Negative-Pressure Wound Healing Device
-- article & patent

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**Danielle ZUROVCIK****Negative-Pressure Wound Healing Device**

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**Accelerated wound-healing with
vacuum-assisted skin dressing**



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[**http://www.technologyreview.com/news/418098/a-cheap-portable-wound-healing-device/?a=f**](http://www.technologyreview.com/news/418098/a-cheap-portable-wound-healing-device/?a=f)**March 19, 2010**

**A Cheap, Portable Wound-Healing Device**

***After the Haiti earthquake, physicians
tested a vacuum pump meant to speed healing.*****by** **Emily Singer**

  

![](woundheal.jpg)

  
In mid-February, about a month after a massive earthquake leveled
much of Port-au-Prince, Haiti, a wound-care team from Brigham and
Womenas hospital in Boston traveled to the devastated capital. The
teamas task was to help care for scores of patients suffering from
the large open wounds that accompany amputations, crushed limbs,
and other injuries. Among the team was MIT graduate student
Danielle Zurovcik, who arrived ready to test a device she had
developed as part of her thesis researchaa cheap and portable
version of the negative-pressure devices currently used to speed
wound healing in hospitals.  
  
Zurovcik and her collaborators hope the device, which costs about
$3, will provide a way to improve care for patients after the
emergency phase of relief efforts, including life- and limb-saving
surgeries, has ended. Even after many of the emergency medical
teams leave the disaster zone, the dangers of chronic wounds
remain high.  
  
aMy experience in Haiti and other major earthquakes is that after
the acute medical response, such as amputating limbs and setting
fractures, the major disease burden is wounds,a says Robert
Riviello, a trauma surgeon at Brigham and Womenas, and Zurovcikas
collaborator. Negative-pressure therapy decreases the need to
change wound dressings from one to three times per day to once
every few days, a major benefit when medical staff is in short
supply.  
  
Negative-pressure devices, which act like a vacuum over the
bandaged wound, have become a central part of wound therapy in the
United States over the last decade. They speed healing up to
threefold, depending on the type of wound, and in some cases
eliminate the need for plastic surgery or skin grafts. A number of
commercial versions are available in the U.S. and are used to
treat burns and chronic wounds such as bed sores or diabetic foot
ulcers. While scientists donat exactly know why this treatment
accelerates the healing process, it likely helps by removing some
of the fluid and bacteria that accumulates at the injury site and
by increasing blood flow to the wound. The pressure itself may
also help healing by bringing together the edges of the wound and
delivering mechanical pressure, which has been shown to spur cell
growth, says Dennis Orgill, a surgeon at Brigham and Womenas who
was not involved in the project.  
  
Existing devices are often heavy, about five to 10 pounds, and
require an energy source to create the vacuum, making them
difficult to apply in disaster settings. Texas-based KCI, the
leading maker of negative-pressure machines, has a portable
version thatas battery powered, but it costs approximately $100
per day to rent. A number of companies are working on even more
portable versions, say Orgill.  
  
But Zurovcik, inspired by a burn surgeonas plea, went a step
further, designing a human-powered device that applies pressure
via a simple bellows pump weighing less than half a pound. By
improving the seal around the wound dressing to reduce air leaks,
Zurovcik cut the pumpas power requirements from about 14 watts to
80 microwatts, which comes from a hand pump.  
  
aTo basically take a toilet plunger and produce negative pressure
over a prolonged period of time, that is really great,a says
Kristian Olson, a physician at Massachusetts General Hospital, in
Boston, who was not involved in the project. aNot only do I see it
answering this need in developing countries, I think it could
really enhance home therapy for chronic wounds in the U.S.a  
  
Zurovcik and Riviello had been planning a trial of the device in
Rwanda a Riviello spends about half his time working in
Africaawhen the earthquake hit Haiti. Colleagues treating the
first waves of injury victims told the duo that their device might
be of help, so they joined a wound-care team headed for University
Hospital, a few blocks from the leveled palace in Port-au-Prince.
(Commercial negative-pressure devices, known as VACS, were
employed in various relief efforts in Haiti, including $2 million
worth of equipment donated by KCI.)  
  
Working in stifling tents filled with patients, the team tended to
those whose doctors had left and were in need of follow-up care.
Of the hundreds of patients assessed, the researchers chose eight
people suffering from a variety of injuriesa amputations, open
tissue wounds, open fractures, crushing injuries (where the skin
had to be opened to give the muscle room to expand), infected
surgical wounds, and bedsores from being paralyzedaappropriate for
negative-pressure therapy. aBecause this was a disaster setting,
we didnat feel it was an appropriate place for rolling out a
randomized controlled trial,a says Riviello. (They cared for other
patients with typical dressings.)  
  
The surgeon would first apply a sponge over the cleaned wound and
then cover it with a plastic seal. A tube fed through a small hole
in the plastic connected to the pump, which was manually
compressed to create negative pressure. The team trained patientsa
families, who often took on typical nursing duties, to charge, or
pump, the device. aWe learned that family members are interested
in being trained and motivated to keep the device charged because
they saw the benefits for their loved ones,a says Riviello. aThey
were tremendously reliable. We saw patients twice a day, but it
became clear that we could come back days later and the device
would still be charged.a  
  
Because the researchers were in Haiti for just 10 days, they
werenat able to determine if the device helped patients heal
faster. But it did seem to keep the wounds cleaner, says Riviello,
and reduced the need to change bandages, which is painful for the
patient. In fact, one patient requested the treatment after
observing how a neighbor in the next bed was subjected to fewer
painful dressing changes, says Zurovcik. Now back in Cambridge,
she is tinkering with the prototype, trying to further improve the
pressure seal and the amount of negative pressure the device can
deliver.  
  
The team plans a larger test in Rwanda, where it will likely put
the device to broader use. People in poor countries are much less
likely to survive severe burns, for example, which can be helped
with negative-pressure therapy. And the rate of complications from
diabetes, such as foot ulcers, is skyrocketing in these countries
as well, says Olson.  
  


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**Modifiable Occlusive Skin Dressing**  
**US2014031735**  
**[ [PDF](US2014031735.pdf) ]**

  
Occlusive tissue dressings and methods including an elastomeric
drape and a liquid component, at least partially cross-linked at
least after one of drying and curing, suitable for application at
a dressing-to-skin interface in order to create a substantially
air-tight seal. The same or a different liquid component may be
applied by a user at a tube-to-dressing interface in order to
create a similar air-tight seal around the tube, if not
occlusively sealed during its manufacture.  
  
**CROSS-REFERENCE TO RELATED APPLICATION**  
[001] This application claims priority to U.S. Patent Application
No. 13/745,690 filed January 18, 2013 and U.S. Provisional
Application No. 61/588,121 filed 18 January 2012.  
  
**FIELD OF THE INVENTION**  
[002] This invention relates to dressings intended to provide a
fluid-impervious barrier over skin, and more particularly to
dressings suitable for negative pressure wound therapy.  
  
**BACKGROUND OF THE INVENTION**  
[003] Negative pressure wound therapy ("NPWT") is an effective
technology for treating open wounds. NPWT devices were originally
accepted by the US Food and Drug Administration ("FDA") in 1995,
when the FDA approved a 510(K) for the Kinetic Concepts Inc.
("KCI")'s V.A.C.(R) device. The definition of NPWT devices by the
FDA has changed over the years; in general terms, its definition
is: a system that is used to apply negative pressure for wound
management purposes, including the removal of fluids (i.e., wound
exudates, irrigation fluids, and infectious materials). The
negative pressure is applied through a porous dressing positioned
into or over the wound cavity, depending on wound type and depth,
or over a flap or graft; the dressing distributes the pressure
while removing fluids from the wound. NWPT systems typically
include:  
  
<-> Non-adhesive wound dressing used to fill the wound
cavity (e.g., a sterilized medical sponge or gauze; a.k.a.,
non-adhesive packing materials);  
  
<-> Drainage tube placed adjacent to or into the dressing;  
  
<-> Occlusive transparent film placed over the dressing (and
potentially the drainage tube) and adhered to the skin to maintain
a seal;  
  
<-> Collection container for drained fluids from the wound;
and  
  
<-> Low pressure vacuum source.  
  
[004] NPWT has been approved by the FDA to treat many wound types:
chronic, acute, traumatic, sub-acute and dehisced wounds,
partial-thickness burns, ulcers (such as diabetic, venous or
pressure), surgically closed incisions (a.k.a., closed surgical
incisions), flaps and grafts. The prescribed therapy time depends
on wound type, wound dimensions, and patient conditions; it
typically lasts from four weeks to four months. Disposable
dressing components are changed approximately every three days.  
  
[005] Extensive clinical trials have demonstrated the success of
negative pressure in healing the approved wound types by applying
a controlled negative pressure typically between 20mmHg and
200mmHg. Most studies applied a constant vacuum pressure, with
125mmHg being the most common, although cyclic and intermittent
studies are currently underway. Evidence supporting the use of
NPWT in the treatment of chronic, non-healing wounds exists
primarily in the form of nonrandomized, controlled trials;
prospective and retrospective large and small case series;
single-center studies; and single case studies, with few
randomized, controlled clinical trials. Studies also exist that
demonstrate NPWT benefits in healing acute wounds. Additionally,
since 2006, benefits of managing surgical incisions
post-operatively have been shown with improved clinical outcomes;
at least ten studies have been published to date. From these
studies, proven medical benefits of NPWT treatment include:  
  
<-> Promotes blood flow (perfusion) at the wound;  
  
<-> Removes interstitial fluid (a.k.a., wound exudates),
reduces edema;  
  
<-> Decreases counts of bacteria and infectious materials;  
  
<-> Increases rate of granulation tissue formation, reducing
scar tissue formation, increases growth factors and fibroblasts;  
  
<-> Uniformly draws the wound edges together;  
  
<-> Provides a protected healing environment; and  
  
<-> Provides a moist environment.  
  
[006] Although significant clinical evidence exists to support the
benefit of NPWT as a safe therapy in healing chronic wounds, it is
possible during NPWT to rupture a vein or artery. Usually, a
machine safety alarm will signify a fluid leak rate that exceeds
the rate that the machine was designed for. This alarmed leak rate
typically includes the combination of both air and liquid, and
typically has an upper safety limit of the minimum blood flow rate
possible out of a wound cavity with an actively bleeding vein or
artery. If a vein or artery accidently ruptures, the system must
shut down. Therefore, it is very important to have a safety
feature that stops blood flow if this occurs, in order not to
exsanguinate the patient.  
  
[007] Lina et al. describe in U.S. Patent No. 7,611,500 and
WO1996/005873 an initial apparatus used for NPWT. In practice, the
device proved to be effective; however, one major limitation was
detected: the high electrical grid power source needed to operate
the device limited the mobility of a patient. Therefore, future
refinements, such as that described by Hunt et al. in U.S. Patent
No. 6,142,982, incorporated rechargeable batteries for the power
source. Batteries increased patient mobility, but time was limited
by the life of the batteries between charges. Additionally,
battery management became an issue, especially for facilities with
a high number of NPWT patients, and electrical grid power was
still needed to recharge the batteries.  
  
[008] Eliminating the need for electrical power, via the grid or
batteries, would create a more widely applicable, clinically
viable therapy. The power requirement variability of a system is
dependent on the desired vacuum pressure, rate of wound exudate
removal from the wound cavity, and the leak rate of air into the
system. As the air leak rate increases, more power is needed to
supply a continuous negative pressure at a predetermined value or
threshold range at the wound bed. Air leakage into the NPWT system
requires the most power of any other component. Air leaks are the
obstacle to creating a vacuum system that does not require a
continuous external power source or frequent recharging of its
internal power storage. Therefore, the feasibility of a mechanical
NPWT system is heavily reliant on the seal quality of every
interface in the system. The dressing system has been identified
as the main source of air leaks in current NPWT systems,
particularly at the interfaces between 1) the dressing and the
skin and 2) the tube and the dressing. The amount of air leaks
into these interfaces determines the time frequency that the pump
needs to be recharged and the magnitude of vacuum pressure applied
to the wound cavity at a specific time. These two latter
characteristics are dependent system parameters.  
  
[009] Few mechanical NPWT systems are currently available, as
described by the present inventor in "Development of a simplified
Negative Pressure Wound Device" submitted in 2007 for her Master
of Science in Mechanical Engineering at the Massachusetts
Institute of Technology. Certain lower-pressure, mechanical
devices were disclosed later by Hu et al. in U.S. Patent
Application No. 2010/0228205. Current mechanical systems typically
use sophisticated-material, planar dressings, such as hydrocolloid
dressings, to try to solve the air leak problem. However, the
inherent geometry mismatch of a planar dressing and the contoured
skin surface often leads to air leaks. The mechanical devices
therefore are only applicable for select, relatively flat surfaces
on the body and, even then, it is difficult to eliminate air leaks
entirely. [010] Non-electrical pumps are at the low end of the
spectrum of medical pumps, typically utilizing bladder pumps and
capillary action materials. Bladder pumps are used for both
extracting and inserting fluids. By their physical
characteristics, they are governed by non-linear spring like
properties. Currently, bladder pumps are used in wound treatments
for drainage purposes, particularly for internal, body cavity
drainage. C. R. Bard, Inc. manufacturers many of these
non-electrical pumps; one bladder model frequently used to drain
internal cavities is commonly referred to as a Jackson Pratt
Drain.  
  
[011] There are various limitations to applying NPWT with existing
mechanical, bladder pumps. There are no pressure gauges on the
pumps and, therefore, the user does not know the initial magnitude
of the negative pressure pulled, and cannot monitor the pressure
during therapy. Additionally, there are no air leak detection
systems for the current pumps, except to visually watch for the
expansion of the bladder at a rate higher than expected. If the
pump is clear, one can also visually monitor if the expansion rate
is due to air leaks or due to drainage fluid.  
  
[012] Capillary action materials are also currently used to treat
wounds by providing very low negative pressure treatment, too low
to be considered NPWT. This form of treatment is usually found in
dressings such as small topical bandages to provide NPWT- like
benefits to very small, self-healing wounds, such as blisters and
brush burns. Treating a wound with this technology enhances the
healing environment. Capillary action materials are filled with
small capillaries between the wound and outside environment. A
negative pressure is applied by capillary action of fluid flowing
from the wound to the outside environment, thereby, removing
interstitial fluid. One example of a capillary action material is
Johnson & Johnson's First Aid Advanced Care Advanced Healing
Adhesive Pads.  
  
[013] Dressing technologies have tried to address the issue of air
leaks into NPWT systems. This is important to both electrical and
mechanical systems to reduce their necessary power requirements.
In mechanical systems, it is necessary for clinically relevant
device functionality, such that power input and pump recharge time
is reasonable for a caregiver and/or patient to perform. For
electrical systems, air leak reduction reduces the number of, if
not completely eliminates, false-positive, alarmed emergency
system shutdowns. Air leak reduction allows battery designs to
last longer on one battery charge and use lower power capacity
batteries altogether. Air leak elimination potentially eliminates
the need for a continuous power supply, as the vacuum pressure can
be maintained in the occlusive environment within a specified
threshold, for which the timeframe depends on the pump parameters
and exudate removal rate (typically less than 100 mL/day) from the
wound.  
  
[014] Currently, most NPWT dressings (the drape component) are
thin, planar, tape-like adhesive dressings that must be applied to
a contoured area of skin. A backing on the dressing must be
removed to expose the adhesive, and then the dressing is applied
to the skin. The pre-application handling of the dressings alone
introduces a probability for air leaks, as the dressing typically
folds onto itself or creases very easily due to its low bending
stiffness; many dressings are thinner than a piece of standard
paper, and the bending stiffness of a material is proportional to
the inverse of its thickness cubed. As a dressing is applied, it
must often fold onto itself in order to accommodate for a
geometrical mismatch between the planar dressing and the contours
of the body surrounding the wound to be treated. This creates
creases, also referred to herein as wrinkles, in the dressing that
have a high potential for causing air leaks into the NPWT system.  
  
[015] Adding to the geometrical mismatch, the dressings often
become less adhesive due to the introduction of foreign materials
onto the adhesive before dressing application. This is most common
and almost unavoidable at the edges of the dressing due to
handling by the caregiver. At times, the caregiver's hands
introduce enough foreign particles onto the adhesive to forbid
further adhesion of that area of the dressing. In the U.S., this
often happens when a caregiver uses powdered gloves. This is a
critical issue as the edges of the dressing are an area where leak
propagation from the edge of the dressing to the wound cavity is
potentially very high, based on the theory of interface fracture
mechanics.  
  
[016] For the electrical NPWT systems, a thin plastic, adhesive
backed dressing is typically used. Electrical NPWT dressing
systems have not readily addressed the air leak issues listed
above that form at the dressing-to-skin interface. Instead,
dressing iterations have focused on air leaks at the
tube-to-dressing interface. When NPWT was first introduced into
the market, the drainage tube was inserted into the wound cavity
through the edge of the dressing. This introduced a high potential
for air leaks, which often alarmed the shut-off system. Caregivers
began to solve this problem by raising the tube from the skin
surface at the dressing edge, and pinching the dressing under the
tube before the dressing contacts the skin. This caused the
dressing to adhere to itself in an upside-down "T" pattern onto
the skin. [017] Eventually, some of the NPWT dressing, commercial
designs incorporated their own solutions to the high air leak rate
at the tubing interface. Out of these solutions, the T.R.A.C. Pad
by KCI was highly effective, which is driving the current design
trends. The T.R.A.C. Pad prefabricates the drainage tube to a
semi-rigid, tubing connector, which is then attached to a small,
circular, planar adhesive dressing (a.k.a., drape). All of these
connections are made air-tight during its manufacture. The tubing
does not travel beyond the plane of the adhesive dressing, and
therefore its opening remains at the skin surface. When the
T.R.A.C. Pad is used, the standard dressing is initially applied
to the wound, without a tubing connection. Then, a small incision
is made in the dressing, over the wound cavity; this hole may also
be prefabricated into the drape component of the dressing during
its manufacture. The film backing of the circular adhesive
component is removed from the Pad, and the tube opening is
centered over the incision. Since the adhesive surface of the Pad
is small, it is easier to handle than the procedure of tunneling
the tube into the initial dressing. Although the Pad does not
guarantee elimination of air leaks at the tube-to-dressing
interface, it highly reduces the probable amount of air leaks into
the dressing, based on its ergonomic design and small profile. A
minimal amount of air leaks is almost unavoidable for all
applications with planar adhesive components, due to the
geometrical mismatch and user handling that still remain.  
  
[018] Many efforts have been made in order to overcome the
identified barriers of low end, mechanical pumps for application
in NPWT. Most of the focus has been on reducing air leaks and
creating more predictable vacuum sources. New materials used in
NPWT dressings have been the main driver in reducing the air leak
rate into the system at the dressing-skin interface. These
materials are often not new to wound dressings; however, they are
new to NPWT. Pump design has been the focus of creating more
predictable vacuum sources; mechanical components, such as linear
or constant force springs, are often introduced into the system
and maintain a more predictable behavior throughout therapy.  
  
[019] Only one mechanical NPWT system is on the market today, but
is not widely used: SNaP(R) Wound Care System by Spiracur
(Sunnyvale, CA). The SNaP(R) Wound Care System uses a hydrocolloid
dressing with specific mechanical connectors from the tube to the
dressing, in order to accommodate for air leaks; the provided
hydrocolloid dressing is relatively small in size. HydrocoUoids
are used in many wound-dressing systems, and are a common trend in
the NPWT market. They are stiffer and thicker than most common,
adhesive, planar, NPWT specific dressings. This causes the
dressing to fold onto itself less during its handling and
application. However, it cannot accommodate for geometrical
mismatch without creases, especially as the dressing surface area
increases. Since the dressing is stiffer and thicker, these
creases are difficult to seal in an air-tight manner, due to its
increased bending stiffness. Therefore, hydrocolloids are often
only applicable to smaller wounds. Much effort is currently being
taken to make them thinner, in order to increase their applicable
surface area and accommodate more for contours, such as the
Replicare Thin Hydrocolloid Dressing by Smith and Nephew.
Hydrocolloids rely on their extremely sticky adhesive properties
to account for increased skin adhesion and reduced air leaks. If
they come in contact with wound exudate, the polymers in the
hydrocolloid swell with water until saturation, forming a gel,
which is held solid in its adhesive matrix structure.  
  
[020] In the SNaP(R) Wound Care System, the hydrocolloid dressings
are connected to the tubing with a mechanical connector component,
similar to the T.R.A.C. Pad, KCI. The SNaP(R) Wound Care System
eliminates any potential air leaks from this mechanical connector
by prefabricating it to the center of the entire dressing during
manufacture. The prefabrication eliminates any potential air leaks
at the tube-to-dressing interface due to user interface and
geometrical mismatch, but it is not capable of being moved on the
dressing surface. Therefore, it may need to be placed on an
inconvenient area of the wound, such as a location that is
uncomfortable for the patient. Additionally, the tube runs
parallel to the plane of the drape; the direction of the tube
along the plane of the drape is fixed. Since the dressings are not
typically round, the tube path may be required to travel in an
undesirable path, in order to cover the wound area with the preset
shape of the drape.  
  
[021] For its vacuum source, the SNaP(R) Wound Care System uses a
complex system, driven by constant force springs. Therefore, as
the pump expands, mainly due to air leaks and potentially exudate
removal, the pressure remains relatively constant for the length
of the pressure application. This system is expensive and highly
technical when compared to the non-electrical pumps at the low end
of the medical pump spectrum (e.g., bladder pumps); however, it is
the first commercial mechanical NPWT pump, which has been proven
to be a potential NPWT pump design. Since air leaks into the
dressing system remain highly probable, depending on wound
location and caregiver experience, the successful application of
the SNaP(R) Wound Care System is limited in practice.  
  
**SUMMARY**[022] Occlusive skin dressings according to the present
invention preferably provide one or more of the following
advantages:  
  
<-> a conformable dressing system that can be altered if
desired and applied to substantially all areas of the skin
surface;  
  
<-> a dressing system that is ergonomic;  
  
<-> dressings that are easy to obtain and re-obtain by the
user, through conveniences in storage;  
  
<-> dressings, pumps, systems, and methods to administer
NPWT without the need for electrical power;  
  
<-> minimizing the amount of air leaks into the NPWT system;  
  
<-> detecting air leaks into the NPWT system;  
  
<-> compatible with light-weight, easily transportable and
low cost pumps; and  
  
<-> mechanical methods to minimize the possibility of
exsanguinating the patient.  
  
[023] Occlusive dressings according to the present invention
overcome the aforementioned drawbacks by being truly air-tight.
One principal application of this technology is to facilitate
administration of mechanical NPWT. A liquid component is applied
at the dressing-to-skin interface in order to create a
substantially air-tight seal preferably for at least 48 hours,
more preferably for at least 72 hours. Preferably the same or
different liquid component is applied at the tube-to-dressing
interface in order to create a similar air-tight seal. In some
embodiments, the liquid components may be made of rubber polymers
applied by touch, by squeezing a dispenser, or by spraying the
polymers with an atomization process.  
  
[024] This invention features a kit suitable for occlusively
sealing a wound penetrating the skin of a patient, including a
drape formed as a thin sheet of an organic, preferably elastomeric
material, substantially impervious to fluid transfer of air and
bodily fluids, having first and second surfaces. A biocompatible
adhesive is at least one of (1) disposed on at least the first
surface of the drape and (2) capable of contacting at least a
portion of at least the first surface of the drape. When the kit
includes the biocompatible adhesive disposed on at least a portion
of the first surface of the drape, the kit further includes at
least a first removable liner sheet covering the first surface of
the drape. In some embodiments, a second removable liner sheet
covers the second surface of the drape, especially when adhesive
is also disposed on the second surface of the drape. The kit
further includes at least one container of at least one sealant
component that is capable of being delivered as a sealant in a
liquid state at pre-selected ambient conditions, the sealant as
delivered being at least partially cross-linked at least after one
of drying and curing, and which is capable of at least one of
drying and curing within thirty minutes, preferably within twenty
minutes and, more preferably, within ten minutes, after
application of the sealant as a layer to the edges of the drape
after the drape is applied to the skin surrounding the wound.  
  
[025] In some embodiments, the drape and the sealant after one of
drying and curing are elastomeric. In a number of embodiments, the
drape and the sealant are derived from substantially the same
material, such as a type of a latex compound or a type of silicone
compound. In certain embodiments, the adhesive is a silicone-based
adhesive and is disposed on at least a majority of each of the
first and second surfaces of the drape as a solid coating or in a
pattern such as a grid or concentric circles. At least one
container of a sealant component enables manual application of the
sealant in some embodiments, such as by squeezing the container
and, in other embodiments, at least one container is a removable
vial or cartridge insertable into a dispensing apparatus or other
applicator. In a number of embodiments, the kit further includes a
flexible tube having a first end and a second end connectable to a
source of negative pressure such as a bellows, especially a novel
bellows which unrolls, or other mechanical vacuum source.
Preferably, the kit further includes a flange having at least one
of (1) a central passage through which the first end of the tube
is insertable and (2) a central passage communicating with a
connector capable of mating with the first end of the tube. In one
embodiment, the first end of the tube includes a feature such as a
spiral cut to resist blockage of the tube. In some embodiments,
the kit includes at least one non-stick handling component. In a
number of embodiments, the kit further includes at least one wound
packing material.  
  
[026] This invention may also be expressed as a method of
constructing an occlusive dressing over a wound penetrating the
skin of a patient by selecting a drape formed as a thin sheet of
an elastomeric material, substantially impervious to fluid
transfer, and having first and second surfaces. A biocompatible
adhesive is selected that is at least one of (1) disposed on at
least the first surface of the drape, preferably with a first
removable liner sheet covering the first surface of the drape and
(2) applied to at least one of (i) the skin of the patient
surrounding the wound and (ii) at least a portion of at least the
first surface of the drape. Optionally, a second removable liner
sheet covers the second surface of the drape. The method includes
removing the first removable liner, if present, and placing the
drape onto the skin surrounding the wound, removing the second
removable liner if present, and applying a sealant that is in a
liquid state as applied, the sealant being at least partially
cross-linked at least after one of drying and curing, on at least
the edges of the drape and on the skin adjacent to the drape in
one or more layers. The method further includes at least one of
drying and curing the sealant within thirty minutes, preferably
within twenty minutes, after application of the sealant to the
edges of the drape in at least one layer.  
  
[027] In certain embodiments, the adhesive is disposed on at least
a majority of each of the first and second surfaces of the drape,
and/or the method includes pressing on the second surface of the
drape in the vicinity of any wrinkles in the drape, preferably
before sealant is applied in that vicinity. In some embodiments, a
flexible tube is selected having a first end and a second end
connectable to a source of negative pressure such as a bellows or
other mechanical vacuum source. Preferably, the first end of the
tube (1) is inserted through a central passage of a flange secured
to the drape or (2) is mated with a connector on a flange having a
central passage communicating with the connector. In one
embodiment, the first end of the tube includes a feature such as a
spiral cut to resist blockage of the tube. In some embodiments,
the wound is packed with gauze or other fluid-pervious material
prior to placing the drape on the skin.  
  
[028] This invention may be further expressed as a method of
constructing an occlusive dressing over a wound, penetrating the
skin of a patient, by at least one of (1) packing the wound with a
fluid-pervious material and (2) covering at least a portion of the
wound with a protective material. The method further includes
applying, such as by spraying, an elastomeric material that is in
a liquid state, and is at least partially cross-linked at least
after one of drying and curing, over the packed material and onto
skin surrounding the wound to create an occlusive drape as a thin
sheet substantially impervious to fluid transfer, having a first,
inner surface and a second, outer surface. The method includes at
least one of drying and curing the elastomeric material within
thirty minutes after application of the elastomeric material as a
layer.   
  
**BRIEF DESCRIPTION OF THE DRAWINGS****[029] In what follows, preferred embodiments of the
invention are explained in more detail with reference to the
drawings, in which:****[030] FIG. 1 is a schematic expanded perspective view of a
drape, flange and tube with first and second liners prior to
application of a liquid sealant according to the present
invention;****[031] FIGS. 2 and 3 illustrate a novel first end of the
tube of FIG. 1 being inserted through the novel, preferably
symmetrical flange;****[032] FIG. 4 is a schematic perspective view of an
alternative novel first end of a tube;****[033] FIGS. 5A and 5B illustrate repositioning of the
upright tube into a desired side orientation;****[034] FIGS. 6 and 7 show a drape being covered by an upper
liner to manufacture a dressing according to the present
invention;****[035] FIG. 8 shows a hole punched in the dressing of FIG.
7;****[036] FIGS. 9 and 10 shows a tube assembly being inserted
onto the dressing of FIG. 8 with the edge of the flange being
sealed to the drape;****[037] FIG. 11 shows a protective liner being added to the
dressing of FIG. 10;****[038] FIG. 12 illustrates how a user can cut the dressing
of FIG. 11 to conform to a wound;****[039] FIG. 13 shows a handling tab being added to the
dressing of FIG. 12;****[040] FIGS. 14 and 15 illustrate debriding and packing an
open wound;****[041] FIG. 16 is a perspective view of the underside of the
dressing of FIG. 1 1 with the bottom, inner protective layer
being removed;****[042] FIG. 17 is a schematic top plan view of a dressing
according to the present invention attached to skin surrounding
the wound;****[043] FIG. 18 is a schematic perspective view of the
dressing of FIG. 17 with the upper protective liner being
removed;****[044] FIG. 19 shows liquid sealant being applied to the
edges of the drape of FIG.****18;** **[045] FIGS. 19A and 19B illustrate modifying the coverage
of a dressing according to the present invention;****[046] FIG. 20 is a schematic expanded view of a vial of
sealant with a non-stick finger protector optionally
positionable within the vial for storage and transportation;****[047] FIGS. 21 A and 2 IB show a dispensing apparatus with
removable cartridge of liquid sealant;****[048] FIG. 22 is an enlarged perspective view of the
cartridge of FIGS. 21 A and****21B;****[049] FIG. 23A is schematic perspective view of a
hand-powered squeeze applicator for liquid sealant;****[050] FIGS. 23B and 23C are enlarged views of the outlet
with and without a removable strip covering the dispensing
openings;****[051] FIGS. 24 and 25 are schematic top plan views
illustrating non-stick gloves and finger covers, respectively,
integrated into a liner;****[052] FIGS. 26-28 are schematic top plan views liners
having different shapes;****[053] FIG. 29 is a schematic side view of a dressing
according to the present invention being applied to the heel of
a foot;****[054] FIGS. 30 and 30A are enlarged schematic views of the
dressing of FIG. 29 with a fold being created and then pressed
flat to enhance conformance to the heel;****[055] FIG. 31 is a cross-sectional view of a known bellows
pump;****[056] FIG. 32 is a perspective view of a novel rolling
bellows pump;****[057] FIG. 33 is a flow chart of a sample occlusive
dressing method;****[058] FIGS. 34 A and B are diagrams comparing active versus
passive flow NPWT systems;****[059] FIG. 35 is a diagram of a method to prevent
undermining of the dressing due to exudate build-up in the
passive NPWT system;****[060] FIG. 36 is a diagram of some of the specific
components of an occlusive wound dressing embodiment;****[061] FIG. 37 is a diagram of a tube connection method with
a spiral end tube;****[062] FIG. 38 is a schematic top plan view of the wound
shown in FIG. 14 with the additional step of applying a
protective covering over the wound;****[063] FIG. 39 is a view of FIG. 38 with a hole cut in the
protective covering;** **[064] FIG. 40 is a view of FIG. 39 with a tube assembly
placed over the hole;****[065] FIG. 41 is a view of FIG. 40 with liquid drape
material applied over the protective covering and onto
surrounding skin to construct a dressing according to the
present invention;****[066] FIG. 42 is a schematic perspective view of the
dressing of FIG. 41; and****[067] FIG. 43 is a schematic perspective view of a novel
flange according to the present invention with integral
connector.** **![](us1.jpg) ![](us2.jpg) ![](us3.jpg)  
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![](us19.jpg)****DETAILED DESCRIPTION**[068] This invention may be accomplished by a kit, dressing
system or method utilizing a drape formed as a thin sheet of an
organic, preferably elastomeric material, substantially impervious
to fluid transfer of air and bodily fluids for preferably at least
48 hours, more preferably at least 72 hours, having first and
second surfaces. Preferably, a biocompatible adhesive is disposed
on, applied to or contacted with, at least the first surface of
the drape. In a number of constructions, a first removable liner
sheet covers the first surface of the drape and, optionally, a
second removable liner sheet covers the second surface of the
drape. The invention further utilizes a container of at least one
sealant component that is capable of being delivered as a sealant
in a liquid state at pre-selected ambient conditions, the sealant
as delivered being at least partially cross-linked at least after
one of drying and curing, and which is capable of at least one of
drying and curing within thirty minutes, preferably within twenty
minutes and, more preferably, within ten minutes after application
of the sealant as a layer to the edges of the drape after the
drape is applied to the skin surrounding the wound.  
  
[069] The occlusive dressings presently disclosed address the
power/mobility and air leak issues by eliminating the need for an
electrical power source and by maintaining reliably air-tight
interfaces, particularly at 1) the dressing and the skin and 2)
the tube and the dressing. The disclosed dressing systems and
their connection methods allow for reliable, mechanical NPWT
systems. Not only does this eliminate patient mobility and battery
management issues, but it also allows NPWT to be administered in
austere environments, where electricity is often scarce and harsh
environments require robust products. Multiple disclosed
embodiments support an inexpensive, robust therapy method for
global application. Additionally, dressings according to the
present invention are MRI- compatible.  
  
[070] In order to obtain an air-tight skin dressing, the present
occlusive dressings use a liquid sealant. This liquid sealant may
dry and cure fast, even immediately or effectively immediately,
upon application to the skin or other dressing components, into a
continuous, occlusive film or sheet of material. The drying and
curing processes may occur simultaneously, may be driven by
evaporation, may require a curing agent and/or accelerator, and/or
may be enhanced or controlled with a curing agent and/or
accelerator. Any extra additives (e.g., curing agents and
accelerators) may be added just before, during, and/or after the
sealant application process, depending on its chemical reaction
with the sealant and its rate.  
  
[071] The liquid sealant bonds to the component(s) that it is
meant to seal. The ability of Van der Waals forces to provide the
bond strength without an added adhesive is based on the material
and its thickness. Theoretically, the debond toughness (strength
of the bond) must be greater than the debonding energy, and the
debonding energy is proportional to: the thickness of the
material, the strain in the material squared, and the elastic
modulus of the material. Specifically (on a first order basis; as
its basis is a small strain analysis), the bond strength of a thin
film must abide by Equation 1, where [Gamma] is the debond
toughness, [sigma] is the debonding energy, [Omega] is a
dimensionless prefactor, h is the thickness of the film,
[epsilon][tau] is the strain in tension, and Ef is the elastic
modulus of the film, in order to maintain adhesion to the skin in
tension:  
  
[Gamma] > [sigma] = [Omega]1[iota][epsilon][tau][3/4](1)  
  
Therefore, a highly elastic, thin film presents the ideal material
properties for reduced, required adhesion strength, increasing the
functional applicability of the Van der Waals forces.  
  
[072] An additional adhesive, such as a silicone-based,
latex-based, or acrylic- based glue, having one or more
components, might be employed to produce the desired bond strength
(for example, Liqui-Tape Silicone Adhesive, Waterproof by Walker
Tape Co., West Jordan, UT). This adhesive can be applied under the
liquid sealant or chemically mixed with the liquid sealant prior
to its application, depending on its chemical make-up and final
mixing properties. When applied under the sealant, the adhesive
may need to become tacky (a.k.a., applied set time) prior to
sealant overlay. A fast-setting, two-part sealant that is mixed
prior to use may be useful in some circumstances, such as Skin
Tite(R) silicone available from Smooth On, Easton, Pennsylvania,
which is ACMI Certified Safe and may be used by itself or mixed
with a thickener, such as Thi-vex(R) thickener, also available
from Smooth On. A polymer sealant, or other material with the
ability to bond into a continuous occlusive sheet, with
adhesive-like properties due to high Van der Waals forces may be
desirable, where no additional adhesive is needed.  
  
[073] Rubber polymers, such as latex, synthetic rubber, and
hypoallergenic latex, are examples of polymers with desired
properties for both the dressing-to-skin and tube-to- dressing
interfaces. For example, Deviant Liquid Latex from Deviant, a
subsidiary of Envision Design, San Jose, CA and Liquid Latex
Fashions Body Paint from Liquid Latex Fashions, Warrington, PA
were both demonstrated to seal the dressing at both dressing
interfaces. The drying and curing time for the latex was
significantly reduced by applying the liquid to the skin with an
atomization process, which is further disclosed in the sections
below, by adding alcohol, which helps to absorb the water that
evaporates from the latex, and/or by flowing a gas across the
sealant for convection drying. For most applications, the
curing/drying time was lowered to immediately (at most 1 minute)
from the 5-10 minutes previously stated by Deviant at
http://www.liquidlatex.net/.  
  
[074] Examples of suitable latex materials include Vytex Natural
Rubber Latex (NRL), a brand of natural rubber latex produced and
marketed by Vystar Corporation, Duluth, GA. Vytex is manufactured
by Revertex Malaysia and distributed by Centrotrade Minerals and
Metals, Inc. Protein test results show that Vytex NRL typically
has 90% fewer antigenic proteins than Hevea natural rubber latex.
Therefore, Vytex causes less exposure and developed latex
sensitivities. The Vytex has two products with different levels of
ammonia; ammonia is a stabilizer and preservative, and both
functionally are feasible for the NPWT liquid sealant and drape
components, although alternative stabilizers to ammonia may
irritate the skin less. Liquid latex for body painting typically
contains ammonia, which is what has been applied to patients
during field studies with no irritations. Vytex NRL, low ammonia
compound, has provided functional, occlusive drape and sealant
components on clean, unwounded skin in a lab setting.  
  
[075] Yulex Corporation, Phoenix, AZ creates hypoallergenic latex
from guayule (Parthenium argentatum). Yulex's guayule biorubber
emulsions and solids have none of the sensitizing antigenic
proteins found in traditional Hevea latex and is considered a safe
alternative for people with Type I allergies. Yulex's biorubber
emulsions are registered with the Personal Care Product Council
and its INCI name is Parthenium argentatum Bark Extract. This is a
presently preferred material for the NPWT dressing and sealant, in
order to provide a non-allergenic material option. Yulex presently
has ammonia and ammonia-free options.  
  
[076] Synthetic materials such as nitrile rubber and neoprene are
alternatives to natural rubber that do not have allergy-provoking
proteins, but can also generally have poor elasticity with higher
risk of break rates and viral penetration rates. Therefore, they
are less ideal for many of the dressing applications according to
the present invention, but may be suitable in some circumstances,
particularly for the drape for which curing on the skin and drying
time are not issues. Other multi-part materials, such as Room
Temperature Vulcanizing silicones and certain polyurethanes which
are two-part materials with base and curative components, may be
acceptable in some applications.  
  
[077] Extremely low stiffness, which is achievable with many
rubber-type materials, increases its bonding ability through Van
der Waals forces alone. The high elasticity capable of being
achieved using rubber polymers accommodates for the high levels of
tensional strain reached at the skin surface during large
deformation body movements. Additionally, the material properties
of rubber polymers may also accommodate for the tendency to buckle
when compressive strains are applied, depending on any initial
interface crack sizes and adhesion strength. A desirable sealant
accommodates for the large variability over time and surface area
of the skin surface strains experienced during large deformation
human motions; in the literature, the maximum large deformation
strain is indicated to be approximately 0.45 in tension and 0.3 in
compression. As rubber mechanical properties are sufficient to
achieve structural integrity, the Van der Waals adhesive
properties determine the applicable occlusive sealants, and
depending on the polymer, an additional adhesive may be necessary.  
  
[078] The liquid sealant should have viscosity and curing
properties, preferably including minimal shrinkage, that enable it
to conform to all contact surfaces during the application and
curing processes, such that no air leak channels at the interface
are present after its application. At the dressing-to-skin
interface, the sealant should conform to the folds and creases in
the skin that are often bridged when applying a standard, planar
wound dressing. These types of bridged cracks at all component
interfaces are often a significant source of air leaks into the
system without a liquid sealant. Once a crack exists, crack
propagation occurs in tension and compression with reduced,
applied strains, so air leak channels can form overtime with
reduced strain magnitudes. Therefore, eliminating any initial
cracks at all of the interfaces is desirable. At the
dressing-to-skin interface, structures, such as hair, often create
opportunities for crack propagation and air leaks into a wound
dressing, and therefore, hair is often shaved before dressing
applications. The need to shave the hair from an infectious
standpoint is not desirable, as the shaving process creates trauma
at the hair follicles and increases the risk of infection. With a
liquid sealant, these structures can be completely enclosed in the
air-tight sealant, and therefore, are not a source of crack
propagation under the sealant and do not typically require removal
prior to the sealant application, as cracks at the dressing edges
are most critical to seal, in order to resist crack propagation
due to tension. In some constructions, adhesive on the first
surface of the drape is sufficiently thick and/or flowable to seal
around hairs and skin crevices and to minimize crack propagation.  
  
[079] The sealant thickness, number of components, wound location,
and sealant viscosity determines the optimal sealant application
method(s). The liquid sealant may have a very high to low
viscosity, as long as it can completely wet the contact surfaces.
If mechanically applied (e.g., brush or "painting" application,
roller application, sponge/dabbing application, squeegee or other
squeeze-type application, application by-hand (i.e., finger) with
or without a non-stick cover, etc.), a viscosity that avoids
run-off due to gravity is preferable in order for the sealant to
be ergonomically applicable to any wound location. This leads to
higher viscosities and is limited at the low viscosity range.
Painting is not the preferred application method; when painting
the sealant, it is difficult to achieve a constant thickness. If
the thickness varies significantly over its surface area, the
mechanical properties and debonding energy will also vary
significantly, which may cause occlusive dressing failure.
Painting also has other drawbacks, as it is easy to trap air
bubbles in the sealant, which are a source of cracks for crack
propagation. Also, it is difficult to produce and maintain a very
thin coat, which significantly increases the necessary Van der
Waals bonding strength; it increases the stiffness of the final
dressing and decreases its ability to conform to large tissue
strains.  
  
[080] Spraying is a preferred method of applying the sealant. Two
types of spraying procedures are possible: 1) an aerosol process
which propels the liquid sealant with a pressurized liquid or gas
propellant that forces the liquid sealant through an atomizing
nozzle, and 2) a shearing process which shears the liquid sealant
with a pressurized gas or liquid causing atomization. When
atomized, the layer of sealant material can be made thin enough
that run-off is less of an issue, and therefore a range of lower
viscosities can be used for their desired wetting characteristics.
Additionally and in combination, the small atomized particles fill
in the structures on the skin for wetting purposes. The spraying
technique is limited at the high viscosity range, as too high of a
viscosity sealant will not be capable of being sprayed with
reasonable pressures and velocities for application in the
clinical setting onto skin. However, this is not seen as a
negative aspect since liquids with very high viscosities often do
not properly wet the complex contours of the skin surface.  
  
[081] The shearing process may be preferred over the aerosol
process. One reason for this preference is that nozzles clog
easily with long polymer chains, unless the liquid can be further
thinned. Using the shearing process, the shearing fluid and
sealant fluid may be kept separate until they are both external to
the nozzle head. Therefore, internal clogging of the nozzle does
not occur when properly designed, including a fluid filter (if
necessary) and the proper nozzle orifice size. Gas is the
preferred shearing fluid, as it does not add additional liquid to
the system for drying purposes, it is easy to propel since it can
be compressed to high pressure levels, and it helps to dry the
sealant when spraying it onto the skin. Higher viscosities and
materials with long polymer chains are capable of being sprayed by
the shearing method rather than the propellant method, although
the viscosities and chemical chains that can be accommodated with
the propellant method can be increased with complex nozzle design.  
  
[082] Additives such as curing agents, accelerators, convection
drying agents, and adhesives may be applied via separate
application methods, if they are not mixed with the sealant prior
to application. Their application method may be via painting or
spraying. The application of these additive components and the
sealant may occur in a multi-step process. They may be stored and
applied from separate containers with the same or different
application methods in series or in parallel. However, they may
also be applied in parallel or series from the same containing
body. One example is a parallel spraying process, for which three
ports exist: the sealant port, the shearing fluid port, and an
accelerator port; these three components can combine during the
atomization process in the spray nozzle where the three ports may
interact. Another example is a spray apparatus that allows the
amount of sealant (and potential accelerator) to be controlled,
such that it may be shut-off; the shearing gas then becomes a
convective drying gas.  
  
[083] Various polymers with rubber-like properties were determined
to have the desired sealant properties. Additionally, a preferred
sealant cures immediately or within a few seconds after surface
contact. With these characteristics, the polymer tends to have
long and heavy polymer chains, and therefore, requires the higher
atomizing forces capable with the shearing process. As gas is used
to atomize the polymer, there is a desirable range of gas
pressure, velocity, and volume flow combinations that are required
for the desired, continuous-film outcome. Filtered air, pure
oxygen, and carbon dioxide are examples of applicable shearing
gases that can be readily used, and are often available in the
clinical setting at the desired pressures and volume flow rates.
They are also readily available outside the clinical setting.
Using these gases, the necessary, shearing atomization process is
capable of being designed into a miniaturized handheld device.
This process and design is similar to the consumer use of the
aerosol embodiment commonly found in consumer products and is
further disclosed in the Dressing   
  
**Application Methods section.**  
[084] The thickness of a desired seal embodiment can be built-up
in a successive layered, lamination process. A material that has a
strong affinity for itself with either strong Van der Waals forces
or chemical bonds that form between its layers, such that the
final material behaves as a continuous one-layer sealant is
desirable. The desired thickness is the minimal thickness needed
for strength and to achieve the desired occlusive properties,
which is material dependent. This thickness is often thinner than
the thickness that can be reliably and uniformly achieved through
a painting process, and therefore a spraying process is often
preferred. The atomization process provides a method to achieve
the thinnest functional sealant thickness.  
  
[085] Occlusive dressings are beneficial beyond NPWT and in
combination with advanced NPWT features. Some proven benefits of
occlusive properties are highlighted here. The occlusive
characteristic may enhance the penetration and absorption of
topically applied medications, such as ointments, powders and
creams, which can be beneficial in combination with standard wound
dressings and with therapies, such as NPWT. The V.A.C. Instill
Therapy Unit (KCI) was meant to combine instillation therapy with
NPWT. Instillation, as defined by the V.A.C. Instill
documentation, includes both: 1) the introduction and removal of
topical solutions in liquid form and 2) the ability to flush out
and clean a wound through a rigorous irrigation technique. The
main caregiver complaint about this and other
instillation-purposed dressings is that they often leak liquid
during the instillation process, especially during a rigorous
irrigation procedure, which further induces air leaks during
continued therapy. The occlusive seal and dressings disclosed in
this disclosure would solve any leak issues that arise. Often the
irrigation process introduces leaks by propagating cracks in the
dressing; by eliminating these cracks, the sealant and dressing
techniques in this disclosure significantly reduce the potential
for leaks and leak formation during instillation. The port(s)
needed for instillation fluid insertion and removal can be
directly connected to the disclosed occlusive dressing embodiments
with the same tube-to-dressing connection methods that are
disclosed in the Tube-to-Dressing Interface section in this
disclosure.  
  
[086] Although the presently disclosed occlusive dressings were
developed with NPWT system in mind, they can be used for any
application for which an occlusive (a.k.a., air tight and water
tight), air tight, or water tight seal to the skin is desirable.
Therefore, they are applicable in multiple fields beyond NPWT, and
more generally in the field of skin sealants and their methods.
Truly occlusive dressings create a control volume over the area of
tissue that they are applied, which is a desirable feature for
multiple applications, many which are disclosed in this
application document.  
  
[087] The occlusive dressings discussed in this disclosure are the
first skin dressings to provide a control volume, as no other
dressing to-date is proven to be (reliably) truly occlusive. This
would benefit the enhancement of advanced healing therapies that
are sensitive to any variation in the environment, such as stem
cell based therapies, for which complete control of the
environment is necessary to achieve deterministic results. If a
specific air leak is desirable, its rate can be precisely
controlled into the control volume through precision valves.
Currently, there is no accurate predetermination for the air leak
rate into any wound dressing, especially since most dressing air
leaks have variability over time and with body movement.
Furthermore, truly occlusive dressings may be used in in vivo
acute toxicity tests of dermal irritation and sensitization. The
test animal is shaved and the test material is applied to the skin
and wrapped in an occlusive material. The skin is then exposed
after 23 hours and an assessment for redness and edema is made;
this assessment is repeated 48 hours later. [088] FIG. 1 is a
schematic expanded perspective view of a dressing assembly 20
including a drape 22, a novel flange 26 and a tube 24 with first
and second protective liners 28 and 30 prior to application of a
liquid sealant according to the present invention. Drape 22 and
second liner 30 define holes 32 and 34, respectively, through
which tube 24 is insertable.  
  
[089] FIGS. 2 and 3 illustrate a novel first end 40 of the tube 24
of FIG. 1 being inserted through the novel symmetrical flange 26
to form a tube assembly 27, FIG. 3. First end 40, also referred to
as distal end 40, includes a spiral extension 42 which, in one
construction, is formed by making a helical cut into the distal
end of tube 24. In other constructions, a separate component
having a helical shape or other geometric shape is attached to
serve as a deterrent to clogging of distal end 40. Spiral
extension 42 minimizes possible blockage of lumen 46 through tube
24. Another anti-blockage construction is illustrated in FIG. 4
with a tube distal end 60 defining perforations 62 and 64, notches
66 and 68, and a blunt tip 70. Perforations 62 and 64 can be
formed as diamond-shaped cutouts, circular holes, or other
geometries. A notch 44, FIG. 2, is also created in this
construction to further minimize the possibility for lumen 46
through tube 24 to become obstructed, as described in more detail
below.  
  
[090] Arrow 48, FIG. 2, represents distal end 40 being inserted
through passage 50 in flange 26 defined by a sleeve region 52, a
rotation region 54, and an adhesion region 56 having an outer edge
57. Sleeve region 52 is adhered to tube 24, as described in more
detail below, at a final location such as shown in FIG. 3. In
another construction, sleeve region 52 is attached, via adhesion,
welding or other air-tight connection process, to a short piece of
tube with a connector that connects to a longer piece of tubing.
In yet another construction, the flange includes an integral
connector capable of mating with flexible tubing such as shown in
FIG. 43. Rotation region 54 serves as a flexible ball joint in
this construction. As depicted in FIGS. 5A and 5B, tube 24 can be
manipulated in the direction of arrow 72, FIG. 5A, to a desired
side orientation as shown in FIG. 5B. Lumen 46 through tube 24
remains open in some constructions because distal end 40 extends
beyond adhesion region 56, with notch 44 preferably below sleeve
region 52 but above adhesion region 56, so that rotation region 54
does not collapse onto itself. In other constructions, the flange
is sufficiently short and wide to minimize the possibility of
pinching closed. Sleeve region 52 is sealed in an airtight,
fluid-impervious manner in some constructions by first applying a
silicone adhesive, such as Liqui-Tape adhesive from Walker Tape
Company as mentioned above, to the portion of the outer surface of
tube 24 which will be brought in contact with sleeve region 52
during assembly. A liquid sealant can be applied to the junction
of tube 24 and flange sleeve region 52 to further occlude possible
fluid escape at that junction.  
  
[091] In some constructions, flange 26 is manufactured directly
onto tube 24, via a dipping, molding or spraying process. In
constructions where flange 26 is constructed entirely from, or
coated with, a material that has an affinity for itself, sleeve
region 52 may self-adhere to rotation region 54 and adhesion
region 56, to the extent that region 56 is exposed, when folded
against itself as shown in FIG. 5B. Where the material forming the
exterior of flange 26 has an affinity for the material of drape
22, especially for materials containing latex compounds, the
exterior of sleeve region 52 will also adhere to drape 22 at least
to some extent; latex-type material applied to the surface of tube
24 will further enhance this adhesion. Fixing the tube 24 into a
fixed orientation such as shown in FIG. 5B may be especially
beneficial for bed-ridden or less mobile patients so that the tube
can be positioned to avoid the patient lying on the tubing for
long periods of time or to avoid compromised areas around the
wound. In other circumstances where the tube remains movable, it
can be easily repositioned because rotation region 54 remains
flexible and the tube can be monitored and moved frequently to
assure that tissue is not degraded from lying on the tube in one
position for an extended period. Especially for active patients,
the tube 24 can be periodically re-positioned by the patient or by
a healthcare professional.  
  
[092] FIGS. 6 and 7 show a drape 22 being covered by an upper
liner 30 to manufacture a dressing according to the present
invention. Preferably, drape 22 has a thickness ranging from 2
microns to 0.4mm, especially in portions which will be applied to
skin; a greater thickness in the center portion to be located over
a wound is less critical for occlusivity. In some constructions,
adhesive is pre-applied on the upward-facing surface shown in FIGS
6 and 7, which will be placed in contact with skin during use; in
other constructions, adhesive is also placed on the opposite side
of drape 22, to be covered by liner 30, as indicated by arrow 81
in FIG. 6, for storage and handling. The adhesive is applied as a
uniform coating in some constructions and, in other constructions,
as concentric circles or other non-uniform pattern. Preferably,
liner 30 has extensions 82 and 84 which extend beyond the drape 22
to facilitate handling of the dressing without touching any
adhesive, and to enable easy removal of the liner 30 from the
drape 22 after placement on a patient.   
  
[093] FIG. 8 shows a hole 32 punched in both layers of the
dressing of FIG. 7.  
  
Hole 34, FIG. 1 , is not visible in FIG. 8.  
  
[094] FIGS. 9 and 10 shows a tube assembly 27 being inserted,
arrow 90, onto the dressing of FIG. 8 with the adhesive region 56
to edge 57 of the flange 26 being sealed to the drape 22 utilizing
the pre-applied adhesive. Additional adhesive or sealant can be
added around edge 57 or pre-applied to region 56 as desired.  
[095] FIG. 11 shows a protective liner 28 being added to the
dressing 20 of FIG.10. Protective liner 28 protects the skin-side
adhesive, when pre-applied, until liner 28 is removed as
illustrated in FIG. 16 below. Distal end 40 with anti-clogging
feature 42 is sufficiently relaxed and short in length to be
contained under liner 28. Liner 28 preferably extends beyond drape
22 over regions 82 and 84 of liner 30.  
  
[096] FIG. 12 illustrates how a user can cut the dressing 20 of
FIG. 11, along dashed line 92 using scissors 93 for example, to
conform to a wound.  
  
[097] FIG. 13 shows a handling tab 94 being added, arrow 96, to
the dressing 20 of  
FIG. 12, which is especially useful if liner extensions 82 and 84
are cut away. In this construction, tab 94 is attached by adhesive
95 to one of liners 28 and 30 to assist removal of the selected
liner. Additionally or as an alternative, perforations 97, 98
create locations for easy removal of the liners. If perforations
are utilized, it is preferred that the top and bottom liners have
perforations that are aligned along different angles. The
preferred angle difference is substantially perpendicular, that
is, at about ninety degrees offset. Perforations are preferred
when extensions 82, 84 are not provided. The dressings are very
difficult to handle with medical gloves on, which are required for
sterility. Therefore, handling tabs eliminate the need for the
clinician to touch the adhesive. This is also desirable since
powdered gloves tend to cause the adhesive to adhere to the powder
and loose its adhesion properties. Another solution would be to
provide non-stick finger or hand covers, such as shown in FIGS. 24
and 25, similar to the finger sealant applicator shown in FIG. 20.
This is especially important when dressings are re-shaped,
potentially cutting off handling features, and when the user is
removing the top protective liner and folding down the top folds.
Ideally, additional handling components are built into the
packaging components or protective liners. Such as, the package
that the drape comes in, turns inside out to form a sterile,
handling glove, or the bottom liner is used to maneuver the
higher-level of adhesive interactions when dealing with the top
liner. The bottom liner may have a cut-out (pre-perforated) glove,
FIG. 24, with the non-stick side, e.g. silicone-coated, initially
facing the adhesive; preferably, a non-stick coating is provided
on both sides for both right- or left- handed application.  
  
[098] FIGS. 14 and 15 illustrate debriding an open wound W and
cleaning the wound cavity and surrounding skin SK, preferably at
least 3 cm in width as indicated by dashed line 102, with standard
cleaning methods such as with alcohol and gauze wipes. Typically,
the next step is to pack the open wound W with fluid pervious
material 104 such as gauze, open-cell foam or a sponge.  
  
[099] FIG. 16 is a perspective view of the underside of the
dressing 20 of FIG. 11 with the liner 28 being removed as
indicated by arrow 106, such as by pulling on corner 108, to
expose drape 22 with pre-applied adhesive.  
  
[0100] FIG. 17 is a schematic top plan view of a dressing 20
according to the present invention attached via adhesive drape 22
to skin SK surrounding the wound. When negative pressure therapy
is desired, a source of negative pressure is connected to tube 24
such that its lumen is in communication with the wound cavity.  
  
[0101] FIG. 18 is a schematic perspective view of the dressing 20
of FIG. 17 with the upper protective liner 30 being removed, as
indicated by arrow 110. Dashed line 112 represents a perforation
or pre-cut line to assist removal of liner 30 without sliding it
over tube 24.  
  
[0102] FIG. 19 shows liquid sealant 114 being applied to the edges
of the drape 22 of FIG. 18. The preferred sealant embodiment has
as width of 2-3cm and is centered over the edge of the drape 22.  
  
[0103] If the dressing is applied to contoured surfaces on the
body, such as described below in relation to FIGS. 29-3 OA, folds
in the planar dressing may be necessary for adhering to the
surface of the skin, in order to match the surface contour. These
folds typically travel from the outer edge towards the tube 24. In
this situation, the preferred application method is to minimize
the number of folds by creating a few large folds. Preferably,
there are no more than four folds, divided substantially equally
around the periphery of tube 24. These folds are created when
adhering the drape to the surface of the skin, forming a "T".
Then, when the top protective liner is removed, the folds are
adhered to the surface of the drape with the adhesive on the top
of the drape. Preferably, the folds form individual triangles on
the top surface of the drape. The folds are then pressed to lie
flat and be completely adhered to the surface of the drape.
Sealant is then applied to the edge of each fold to seal off the
area between the fold and the top of the drape from the
surrounding environment. This additional sealant preferably
connects with the sealant placed around the outer edge 114, FIG.
19, for example. Preferably, the additional sealant is applied at
substantially the same time as the original sealant with the same
sealant material. Any drape material that would extend onto the
skin, beyond the original edge of the drape, when folded
preferably is cut off before pressing the folded drape material
against the skin to lie within the original edge of the drape.
Patterns may be provided on the upper protective liner to direct
the user where to put the folds, when needed.  
  
[0104] FIGS. 19A and 19B illustrate modifying the coverage of a
dressing 20a according to the present invention, with drape 22a,
tube 24a and flange 26a. If the dressing 20a is too small to cover
the desired skin area around the wound, preferably by 3 -5cm, for
instance if the user cut away too much of the dressing, as shown
by cut-out 120, while reshaping the drape for easier application
or in order to avoid a complex contour near the wound cavity, the
user can use sealant to reconstruct the dressing as shown by
additional sealant 122, FIG. 19B. A modified occlusive dressing
20a is thereby achieved. However, it is preferable for the drape
22a itself to cover the entire wound edge, in order to protect the
wound cavity from the sealant material.  
  
[0105] FIG. 20 is a schematic expanded view of a vial 130 of
sealant, with closure threads 131 to receive a cap 134, with a
non-stick finger protector 132, shown in cross- sectional view,
preferably with a rim 133, optionally positionable within the vial
130 for storage and transportation.  
  
[0106] FIGS. 21A and 21B show a dispensing apparatus 140 with
removable cartridge 150 of liquid sealant. Dispensing apparatus
140 has a finger trigger 142 and a nozzle 144 in this construction
and can be powered by a cylinder of compressed gas, such as a C02
cartridge, contained within the housing 146. Preferably, the
apparatus is gravity fed. Because there need not be a needle
valve, such as found in typical air guns to stop the flow of
fluid, an adhesive tab 152, FIG. 22, is initially removed from tip
154, and the cartridge 150 is inserted into the apparatus 140 as
represented by arrow 149, FIG. 21B. A plug 156, FIG. 22, is then
removed, such as by twisting, to expose an air hole at the top of
cartridge 150 and activate apparatus 140 and allow sealant to flow
or be sprayed out of nozzle 144. The apparatus 140 can be set
aside temporarily, with nozzle 144 directed upwards, between
sealant layer applications.  
  
[0107] FIG. 22 is an enlarged perspective view of the cartridge of
FIGS. 21 A and 2 IB with internal chamber 160, raised floor 162,
and slope 164 in this construction to assist gravity feed of
sealant liquid to tip 154, as indicated by arrow 166. In other
constructions, a multi-component sealant is delivered utilizing a
separate chamber for each component. The components are mixed
during delivery in a down-stream mixing chamber or in a mixing
nozzle such as the 3M(TM) Scotch- Weld(TM) EPX(TM) Mixing Nozzle
currently available from 3M Company, St. Paul, Minnesota. Other
multi-component delivery systems can be utilized such as those
commercialized by Henkel Loctite Corporation, Rocky Hill,
Connecticut. One or more of the sealant components can be a powder
or other state as long as the final sealant is delivered in a
liquid state, including as liquid droplets via shearing or a
propellant.  
  
[0108] FIG. 23A is schematic perspective view of a hand-powered
squeeze applicator 170 for liquid sealant.  
  
[0109] FIGS. 23B and 23C are enlarged views of the squeegee-type
outlet 172 with and without a removable strip 174 covering the
dispensing openings 176 of passages 178 communicating with inner
chamber 180. In this construction, a removable tab 182, FIG. 23 A,
allows air to enter chamber 180 during delivery of the sealant.  
  
[0110] FIGS. 24 and 25 are schematic top plan views illustrating
non-stick gloves  
191 and finger covers 201 formed in liners 190 and 200,
respectively. These applicators are non-stick, such as by a
non-stick silicone coating, on only one side in some constructions
and, in other constructions, are non-stick on two sides.  
  
[0111] FIGS. 26-28 are schematic top plan views liners 210, 220
and 230 with indicator lines 212 and 214, 222 and 224, and 232 and
234, respectively, having different shapes for selected locations
and contours of a patient. Shorter lines 222 and 234 have priority
if folds are needed; a symmetrical shape such as a square or the
circular shape of liner 210, FIG. 26, has fold lines of equal
priority.  
  
[0112] FIG. 29 is a schematic side view of a dressing 20b
according to the present invention being applied to the heel H of
a foot F. Flange 26b is positioned with tube 24b communicating
with a wound in heel H. One large fold 240 is shown, with edges
244 and 246.   
  
[0113] FIGS. 30 and 30A are enlarged schematic views of the
dressing of FIG. 29 with a fold 240 being created and then pressed
flat to enhance conformance to the heel. All edges 242, 244 and
246 should be sealed with sealant 248 according to the present
invention.  
  
[0114] There are multiple different methods of using the sealant
described in this disclosure at the dressing-to-skin interface.
The first method is to use the sealant in conjunction with
current, commercial skin dressings (or dressings with similar
embodiments), in order to achieve occlusive properties. In order
to do this, the dressing is first applied to the skin, step 1502,
FIG. 33, after the wound is packed, step 1501 ; typically, the
dressing (a.k.a., drape component) is a planar adhesive tape form.
The drainage tube may enter into the dressing at the
dressing-to-skin interface, or it may have its own connector that
requires an incision into the dressing above the wound cavity,
step 1503. The dressing system is applied with its recommended
procedure. Then, all dressing-to-skin interfaces are sealed with
the sealant and potentially additional adhesive, step 1504.  
  
[0115] At the dressing-to-skin interface, the sealant contact with
the skin should be biocompatible. The sealant should conform to
and seal off the folds and creases in the skin, which are often
bridged when applying a standard, planar wound dressing. These
cracks are a significant source of air leaks into the system
without a liquid sealant with the proper wetting properties. The
proper wetting properties are achieved by applying the liquid
sealant directly to the skin and dressing in its liquid form
through a painting process or through spraying the liquid with an
atomization process that eliminates liquid run-off and that may
achieve a more uniform, thin film.  
  
[0116] Once a crack in the planar dressing exists, crack
propagation may occur in tension and compression with reduced,
applied strains. Therefore, sealing any initial cracks in the
dressing-to-skin interface is desirable. Also, properly sealing
the dressing-to-skin interface at the edge of the dressing deters
any air leaks from future crack propagations, as the sealant
hinders the propagation from reaching the outside environment. If
an additional adhesive is used between the sealant and
dressing-to-skin interface, then the adhesive should adhere to the
skin, dressing, and sealant to form the necessary bond strength.
The adhesive or its applied components should also conform to the
folds and creases in the skin and/or dressing. The adhesive should
be compatible with the skin, dressing, and sealant when applying
the adhesive under the sealant, or when mixing the sealant with an
adhesive component prior to application.  
  
[0117] Use of the liquid sealant can permit elimination of the
current commercial dressings (or similar dressing embodiments;
a.k.a., the drape component). The liquid sealant can be applied
directly over the wound cavity and wound packing material. In some
embodiments, the packing material may require an additional liquid
tight barrier if the liquid sealant can be absorbed into the
packing material. Additionally, a liquid tight barrier may need to
exist at the interface between the packing material and the wound
edge, as the sealant could potentially leak into this barrier,
depending on the application technique of the packing material,
which may not be desirable. A gap at the interface between the
packing material and the wound edge may be disruptive to the
sealant in creating a continuously occlusive film, or the
potential of the sealant contacting the inside tissue of the wound
cavity may need to be eliminated. These barriers may be of an
occlusive nature; in this case, the sealant should be applied at
any of their non-occlusive edges; however, the sealant may also
cover the entire surface area, which may help to maintain the
adhesion of the barriers. The barriers can be made of multiple
materials from adhesive and non-adhesive polymer films to clays
and pastes, for example. Barriers mentioned in this description
are different from the standard wound dressings, as the standard
wound dressings' adhesion to the skin forms structural and
adhesion integrities of the dressing-to-skin interface, and the
barriers currently discussed are used to protect the wound from
the sealant component and are not necessarily intended to provide
any structural support beyond that purpose.  
  
[0118] Maceration of the skin under a truly occlusive dressing may
be of concern to the caregiver. This can be solved with a material
selection solution, as a one-way, directional occlusive sealant
material can be used that allows the skin to breathe and its
moisture to evaporate without letting air into the system. Similar
material properties are commonly found today in materials used for
sports apparel. Additionally, this can be solved from a design
perspective. The sealant application area can be made narrow
enough that the moisture of the tissue under the dressing can
diffuse around the seal. If a larger surface area of seal adhesion
is necessary, a web of sealant can be applied to allow diffusion
around the webbing. Additionally, the sealant can vary in
thickness via the atomization process, where a thick enough
dressing for occlusive properties is sprayed around the wound edge
or dressing-to-skin interface. This application can maintain a
narrow width, and then the rest of the dressing can be made into a
thinner layer that is breathable based on a different number of
lamination layers or by using different spraying variables and
techniques. This thinner part of the dressing can maintain a
continuous film embodiment with the occlusive barrier, as the
debonding energy of the thinner part is significantly decreased
due to the reduction in thickness, increasing the effective bond
strength. Additionally, this breathable component can be webbed
over the surface, instead of encompassing a continuous film
embodiment.  
  
[0119] The tube-to-dressing interface should be sealed if the
connection is not prefabricated to be occlusive during its
manufacturing process, as it is in the Spiracur dressing. The
sealant should bond to both materials found at the
tube-to-dressing interface and form an occlusive seal spanning the
interface, step 1504, FIG. 33. Three methods can be used for this
sealant interface and its components: 1) dressing components that
were not originally prefabricated to be occlusive can be
pre-assembled and sealed prior to dressing application (most
desirable from an occlusive results reliability perspective); 2)
dressing components can be preassembled prior to dressing
application, but the seal is applied after dressing application;
or 3) the tube connection method is fabricated and sealed to the
dressing during or post dressing application.  
  
[0120] The first method provides the user with a method to
prefabricate a custom dressing that has an occlusive
tube-to-dressing interface. This eliminates many potential air
leaks, and for the first time, allows custom, prefabricated,
occlusive dressings to be made in the clinical setting. Method two
is convenient if the liquid sealant is the same for all dressing
interfaces; therefore, all the interfaces (tube-to-dressing and
dressing-to-skin) can be sealed in one step after the dressing
application. However, this method requires that the pre- assembly
configuration is stable during its application, before any sealant
is applied. For method three, less prep-work needs to be performed
by the caregiver. If this sealant method is ergonomic and
repeatable without any prefabrication, then this method can
significantly cut-down on dressing time, which is a significant
personnel and cost savings for the care center. The ergonomic and
repeatable characteristics depend on the tubing connector designs.  
  
[0121] Multiple tubing connector designs can be manufactured for
sealing purposes to be used for all three methods. Three basic
design concepts can span many embodiments. These three design
concepts are:   
  
[0122] 1) Puncture the dressing with the drainage tube, such that
the drape fits snuggly against the tube. Then, apply the sealant
at the tube-to-dressing interface. With this method, the tube can
recess into the wound cavity at a custom length as indicated by
extended distal end 1801, FIG. 36. If the adhesion force of the
sealant needs to be increased, an additional adhesive can be added
under the sealant or mixed with the sealant, or the tubing and/or
dressing can be pre-coated with a material that the sealant has an
affinity for. In practice, rubberized polymers typically have a
strong affinity towards themselves, even if the under layer is
previously cured. Multiple drainage holes, as illustrated in FIG.
4, or a spiraled cut pattern, FIGS. 2 and 3, in the portion of the
tube extending into the dressing is preferred, in order to prevent
the tube from occluding against saturated packing material or with
particles in the wound exudate.  
  
[0123] 2) The same concept as in concept 1, except with a
different tube entry into the dressing. This concept is for the
case where an initial planar dressing is used. Two pieces of the
planar dressing cover the wound from two different sides, and they
meet above the wound cavity in a "T" joint. The tube is placed
through this "T" joint into the wound cavity before the "T" joint
is sealed. Then, all of the interfaces are sealed with the liquid
sealant.  
  
[0124] 3) The same concept as in concept 1, except at the
tube-to-dressing interface, a prefabricated foot 1802, FIG. 36,
also referred to herein as a flange, is attached (preferably
air-tight) to the tube in order to provide a planar surface to
seal to the dressing. In one functional embodiment, the foot 1802
is made of a flexible material that the sealant has a strong
affinity for and no additional adhesive is necessary. The material
of the foot may be tapered in thickness, such that it thins to
meet at its edge(s) with the dressing, which may be more desirable
for reliable, occlusive sealant application. The tube can connect
to this foot 1802 in many orientations; however, it is often
preferable to minimize the dressing profile. However, often when
minimizing the dressing profile, the tube is in an orientation
that cannot be readjusted after dressing application. Therefore,
the tube may connect perpendicular to the skin surface, and by
using non-kink tubing and/or the flexibility of the foot 1802
material allows the tube to be oriented in any orientation post
dressing application, such that the tube will not kink and occlude
itself. For this concept, the tube may not puncture the drape, but
instead, the hole (a.k.a., incision) may be pre-cut; the foot
should extend beyond the hole (a.k.a., incision).   
  
[0125] 4) The fourth concept is the similar to concept 3, except
the tubing does not extend into the wound cavity, FIG. 37.
Therefore, an incision is made into the dressing, and the tube
opening is positioned over the center of the incision, as in the
T.R.A.C. Pad. The foot should extend beyond the incision and is
sealed to the dressing with the liquid sealant or occlusively
pre-sealed during its manufacture. In this embodiment, the end of
the tube should be designed to stop potential occlusion onto the
foot, onto packing materials, or with wound exudate substances.
Therefore, if the foot is connected to the tube above the skin
surface, the end of the tube may have a spiral cut along its
length, up to its interface (intersection of the upper portion of
foot 1802 and tube distal end 1901 in FIG. 37) with the foot.
Additionally, an anti-occluding material may be placed at the end
of the tube between the foot and the dressing. This anti-occlusive
material may be a large pore, open cell sponge.  
  
[0126] In the tube-to-dressing connection, as with all sealed
interfaces, an additional adhesive may be added if the bonding
strength needs to be increased. The foot may also be initially
adhered with a tape or adhesive to the dressing prior to sealant
application. The tube connectors can exist in many similar
embodiments to those listed above; however, a limited number of
examples are given here in order to illustrate the basic
connections and the occlusive dressings. The tube-to-dressing
interface may be occlusively pre-sealed during its manufacture.
Additionally, the component attached at the interface may only
consist of a tube connector (which may or may not contain a
segment of tubing) that is additionally connected to a longer
piece of tubing that then attaches to the pump. Examples of
occlusive tube connectors are barbed connectors that connect
directly with a tube, specific connectors that interlock with each
other and are required on each end of the connected components,
and a compression fit seal such as a cylindrical hole in rubber
that the tube can be occlusively pressed into.  
  
[0127] As previously stated, handling a dressing with a planar
tape embodiment may cause the adhesive to weaken prior to dressing
application. Therefore, specific handling devices for the
caregiver can be included with this dressing component. These
devices may include non-stick gloves, such as PTFE gloves, FIG.
24, or non-stick fingertips, FIGS. 20 and 25. Handing tabs that
extend from the dressing may also be incorporated into the
dressing design. These tabs may be a part of the dressing (a.k.a.,
drape) that are torn-off after applying the dressing, or they may
be extensions of a removable backing material that is attached to
the dressing as shown in FIG. 13. [0128] For application of the
sealant, many application embodiments and methods are possible.
For mechanical applications, including painted applications, the
applicator embodiment can be a brush, roller, sponge, spatula, or
other similar embodiment to apply paint in a "spreading" fashion.
These spreading devices can be attached to a container (preferably
refillable) of liquid sealant for a continuous feed of sealant to
the applicator; this may be gravity fed (passive or user
controlled), or the applicator may be prepped with sealant by
dipping the applicator into a container of sealant. Although
painting is not the preferred application method for the liquid
dressing, it may be preferred if a high viscous sealant material
is used to span large gaps, such as that between the packing
material and the wound edge, the potentially high ridges of a
hydrocolloid at its skin interface, or the large creases, gaps,
and folds in a hydrocolloid dressing, due to its high stiffness
and thickness and geometrical mismatch.  
  
[0129] For sprayed applications, the device to atomize the sealant
with a shearing process can be a refillable spray gun or airbrush,
with an external pressurized gas supply, or this functionality can
be incorporated into a miniature, handheld spray can, which can be
rechargeable and refillable. Each embodiment has a design specific
envelope of pressure, velocity and volume flow of gas that is
required to shear the sealant, such that it forms a thin film,
continuous layer on the skin. If the operation is outside the
envelope, the droplets of the spray may be too large and will not
spray as a continuous layer, but will sputter onto the skin, or
the gas may not shear the fluid out of the fluid opening. In a
functional embodiment, the liquid sealant is gravity fed into a
center opening in a nozzle, and pressurized gas shears the sealant
through a circumferential ring around the sealant nozzle opening.
Multiple nozzles may exist for one or both fluids. Particularly,
the spray pattern may be controlled through the shearing of the
sealant from multiple gas ports, aimed in different shearing
directions across the liquid sealant nozzle. In a handheld device,
the pressurized gas may be generated from a miniature gas
cylinder, such as a high pressure, liquid carbon dioxide
cartridge. The spraying device may be charged by the caregiver
when he or she activates the charged canister of gas.  
  
[0130] Once the dressing-to-skin and tube-to-dressing interfaces
are sealed (either during dressing application or during its
manufacture), the caregiver should monitor the pump to assure that
air is not leaking into the system above a predetermined
threshold, typically zero, step 1505, FIG. 33. This can be done
visually, for example, by monitoring the expansion of the pump
(a.k.a., mechanical pump) or with an air leak test that is further
disclosed in the pump descriptions, or it can be sensed using
pressure sensors to detect the vacuum pressure over time
(particularly, with a mechanical pump, if the pressure changes
continuously with internal pump volume). If too high of an air
leak exists, the dressing-to- skin and/or tube-to-dressing
interfaces can be resealed with the liquid sealant by removing the
previously applied sealant material, or overlaying the new sealant
over the previously applied seal material, step 1506, FIG. 33.
This is an iterative process until the desired air leak threshold
is achieved, step 1507.  
  
[0131] When a truly occlusive wound dressing is used for NPWT, the
behavior of the system changes from an active flow system, FIG.
34A, to a passive flow system 1602, FIG. 34B. When air leaks,
arrows 1603, FIG. 34A into the active system, the system has an
active flow of fluid (both air and wound exudate) that both
removes the exudate from the wound cavity 1604 and tends to dry
out the wound cavity. With an air-tight system 1602, FIG. 34B, the
flow of the exudate toward the pump is no longer an active flow,
but tends to build up, 1605, even into the tube over time,
maintaining a passive flow to the vacuum source. A pressure
differential still exists at the surface of the wound bed 1606
and, thus, negative pressure is still being applied to the wound
bed; however, the wound cavity volume 1604 fills with exudate
fluid 1605 over time. This characteristic may have increased
healing benefits compared to standard NPWT, as it maintains a
moist, healing environment at the wound site, while also
maintaining NPWT vacuum pressure benefits.  
  
[0132] With this build-up of fluid 1605, FIGS. 34B and 35, the
dressing-to-skin interface adhesion 1607 may be compromised over
time by the exudate, and the exudate may eventually undermine the
dressing and leak out of the dressing-to-skin interface. The rate
of exudate removal, size of the wound cavity, and time between
dressing changes determine the build-up characteristics. If there
is a chance that the dressing may be compromised, it can be
prevented with multiple methods, including:  
  
[0133] 1) A sealant or additional adhesive that can withstand the
exudate build-up may be applied. For this case, the sealant and/or
additional adhesive should be applied as close to the wound edge
as possible. This is difficult if a standard dressing was used.
Planar dressings typically leak over the three-day dressing period
if fluid build-up occurs. This is because the exudate often
degrades the adhesive by undermining the dressing at the wound
edge at the locations of initial creases in the dressing.
Therefore, a dressing without initial cracks at the wound edge is
preferred; however, the dressing application described in the
previous section only seals the outer edge of the dressing. To
solve this problem, a flexible adhesive, with flexibility and
adhesive properties such as those of a 30+ day silicon wig glue,
may be initially applied at the wound edge under the adhesive
planar dressing. This can fill in any initial cracks at the wound
edge and prevent exudate-caused degradation.  
  
[0134] 2) A barrier can be applied at the wound edge, after the
wound packing material is inserted. This barrier may be made of
highly absorbent material, in order to reduce the chance of
overspill of exudate due to factors, such as gravitational
effects.  
  
[0135] 3) The tube end can be recessed into the wound cavity below
the plane of the surface of the skin 1702, as indicated by arrow
1701, FIG. 35. Therefore, the drainage line of fluid 1703, and
hence the build-up of exudate will not build-up to the wound edge
1607, and degrade the adhesive. This technique may not be possible
if the wound is superficial.  
  
[0136] 4) A purge valve to let a controlled, temporary air leak
into the dressing system to clear the fluid can be incorporated
into the dressing system. This valve can be incorporated using the
same connection methods as described in the Tube-to-Dressing
Interface section in this disclosure. This would cause the fluid
to actively flow into the fluid collection canister during the
initial pressure drop in the system. The pump can be reset, if
necessary.  
  
[0137] 5) The wound packing material can be made from materials
with a low resistance to the flow of exudate and a low absorption,
which would encourage the fluid to passively move through the
system at a faster rate in a path more direct to the drainage
tube. Depending on the rate of exudate removal, this may not fix
the problem if it is a very low rate. In this case, the packing
material should be designed to direct flow to the drainage tube
and specifically away from the wound edge.  
  
[0138] 6) If the dressing is fabricated completely out of the
liquid sealant (potentially with an additional adhesive) with no
planar dressing component, then no cracks will exist at the wound
edge when it is properly applied, and therefore, no cracks will
initially exist for the exudate to undermine.  
  
[0139] Although any mechanical or electrical vacuum source may be
applied to the occlusive dressings in this disclosure, a
mechanical system may be preferred due to the significant benefits
over electrical pumps. Mechanical vacuum pumps and methods are
provided for medical application in negative pressure wound
therapy ( PWT) that would be compatible with the disclosed
dressings. A number of known pumps are described by the present
inventor in "Development of a simplified Negative Pressure Wound
Device" submitted in 2007 for her Master of Science in Mechanical
Engineering at the Massachusetts Institute of Technology. The pump
is initially set and then governed by a linear or nonlinear spring
force. The pump enclosure may act as a collection chamber;
however, a separate collection chamber may exist in series with
the pump.  
  
[0140] In one embodiment, the pump is a plastic bellows, shown in
FIG. 31, where the enclosure and spring can be the same component.
The pump is compressed manually and then attached to the tube of
the wound dressing. A negative pressure is applied through
expansion of the bellows due to the spring characteristics of its
material and design. The pressure gradient of the device
continuously decreases over the expansion of the standard bellows
due to its linear spring-like properties. Referring to the above
description, one skilled in the art would realize that other
embodiments exist: the device could be constructed of a different
material bellows, and/or the device could contain an additional
spring 5 in parallel with the bellows in order to vary the spring
constant without changing the material properties and design of
the bellows itself. If there are no air leaks into the system,
then the bellows would remain at a constant expansion length, and
therefore, at a constant pressure. The bellows can be collapsed to
any desired therapy pressure from maximum compression to zero.  
  
[0141] In addition to the standard bellows, another embodiment of
bellows can resemble a constant force spring, in order to decrease
the pressure gradient. In one embodiment of this design, the
bellows resembles a long tube that, when fully compressed, is
rolled onto itself, similar to a tape measure, as shown in FIG.
32. As it unrolls and expands from its flattened to open
cross-section, it creates negative pressure in the tube to which
it is connected. For the tube to unroll following the expansion of
the bellows, the spring constant of the bellows must be higher
than the spring constant of the constant force spring unrolling.
The unrolling can also be mechanically dampened, for example by
adhesion, or forced to unroll after expansion by structural
limiters. In this embodiment, a long, cylindrical tube can replace
the bellows, as it presents similar characteristics.  
  
[0142] In all of the pumps described above, orientation of the
device is independent of the magnitude of negative pressure pulled
and the proper operation of the device. Therefore, the device is
highly transportable. Referring to the above descriptions, one
skilled in the art would realize that other embodiments exist;
however, only selected embodiments are described in detail. To
change pressures in a pump design, separate pumps can be made with
different material properties and/or dimensions, or components can
be swapped for different pressure results.  
  
[0143] The negative pressure generated is governed by the material
and mechanical properties of the container and/or balloon and the
spring constant. Using a non-constant force spring (such as a
common linear spring 5, FIG. 31, the pump may be used for negative
pressure wound therapy that does not require a specific, constant
pressure (in the case that the internal volume of the pump is
expected to expand), although the variance in pressure can be
reduced through material property selection and design. Using a
constant force spring with a constant area, a constant vacuum
pressure can be pulled throughout treatment, even if there is a
change in the internal volume of the pump. This is the basis for
design of the rolling bellows (FIG. 32), and the syringe concept
discussed in the next section. Additionally, a more constant
pressure with pump expansion can be achieved with a non- constant
force spring by designing the force/area ratio to be constant,
such as the balloon design with a small (constant) diameter to
length ratio and a bellows with a varying cross- sectional area.
Additionally, constant pressure can be achieved over time if no
air leaks into the system, causing geometrical changes in the pump
configuration. In this case, the pumps should be made out of
materials that do not degrade when applying negative pressure
overtime due to properties such as stress relaxation.  
  
[0144] The pump is initially set and then governed by gravity. It
includes an expansion container that expands due to an applied
force such as a weight. The pump enclosure may act as a collection
chamber; however, a separate collection chamber may exist in
series with the pump. In one embodiment, the pump includes a
rolling diaphragm syringe (similar to a friction free diaphragm
air cylinder). Negative pressure amplitude is governed by the
diameter of the syringe and the magnitude of the attached weight.
One skilled in the trade would realize that a similar device could
also be constructed of any sealed piston syringe. Referring to the
above descriptions, the device could also include a linear spring
in parallel with the syringe or a constant force spring in series
with the syringe for expansion, eliminating the need for weight.
This embodiment would then fall under the spring governed pumps
described in the previous section. A rolling diaphragm can also be
achieved using a rubber ball design. One hemisphere of the rubber
ball is held rigid in its inflated position, such as by bonding it
to the inside of a rigid hemisphere, and the other hemisphere is
compressed into it. The embodiment of the pump resembles a bowl.
Then, the bowl is oriented so that its hollow side is facing down.
A weight is hung from the ball (i.e., a rubber ball) on the hollow
inside of the hemisphere, and the wound drainage tube is connected
to the internal volume of the pump (preferably through the top of
the rigid hemisphere). The weight pulls a negative pressure as the
ball returns back to the shape of a sphere.  
  
[0145] Another embodiment for a gravity governed pump is created
by a siphon. The pump enclosure may act as a collection chamber;
however, a separate collection chamber may exist in series with
the pump. The pressure pulled is equal to:  
  
rho\*g\*h (2)  
  
wherein rho is the density of the fluid in the column, g being the
gravitational constant, and h being the height of the column). The
fluid should be compatible with the wound (such as saline), unless
a check valve is used to assure separation of the pump fluid from
the wound cavity. The pump can be configured in two ways,
depending on the patient situation and the desired pressure:  
  
[0146] 1. The pump can include a column of fluid that exists in a
tube directly connected to the wound. The lower (preferably
closed-expandable) container of fluid can rest at the desired
height on a separate mechanism (such as a hanging hook or floor),
or could be attached to a lower extremity of the patient, again at
the desired height. The diameter of the tube would determine the
pressure gradient: the larger the diameter, the lower the pressure
gradient as fluid is collected.  
  
[0147] 2. The pump can include two bodies of fluid with a tube
from the higher body of fluid to the wound. The mobility of the
patient would be determined by the tube length and the mechanism
used to carry the pump (for instance, a rolling stand could be
used). The diameter of the higher container would determine the
pressure gradient: the larger the diameter, the lower the pressure
gradient as fluid is collected.  
  
[0148] Integrating the spring governed pumps with the gravity
governed concept allows for further performance. Then, the
magnitude of negative pressure a spring governed pump can obtain
is not completely limited by the material properties of the
container, the design, and the spring constant combination.
Additional weights can be attached to one end of the pump in
series with the spring, in order to pull a higher negative
pressure. (For the bladder concept, portions of the bladder may
need structural support, so mat the bladder does not collapse on
itself as the weight acts on it.) The weights should be attached
between the pump and ground. Even though in this form the
orientation of the pump should be maintained, varying the
additional weight is a simple solution to achieving multiple
pressures beyond that of the original pump properties.  
  
[0149] A container evacuation pump is not continuously governed by
a force exerted on the container. Instead, the pump is simply an
evacuated rigid chamber that is continuously monitored through a
pressure gauge, such as gauge 4 in FIGS. 31 and 32. Alternatively,
a mechanical check gauge would be used, with an optimal pressure
range. When the vacuum pressure decreases to a certain,
predetermined level, a notification mechanism is activated and the
rigid chamber is recharged. Recharging can be by a pump or by
human suction. In this embodiment, the rigid chamber can act as
the collection container, or a separate non-structural, expandable
container can be inserted into the rigid chamber that is directly
connected to the wound drainage tube. An expandable collection
chamber can be integrated into any of the mechanical pump concepts
disclosed in this disclosure, in order to collect the fluid inside
the pump body, acting as a collection liner instead of a
completely separate collection canister.  
  
[0150] To administer NPWT, the pump is connected to the wound
drainage tube, and the container is then evacuated. Air leaks and
wound drainage rate determines the pressure gradient, and the
pressure range is determined by the maximum pressure pumped and
the recharge notification pressure. The maximum pressure pumped
can be limited by a pressure activated inlet valve.  
  
[0151] As generally applies to all of the above-mentioned pumps, a
sequence of steps should be followed. First, the tube connected
directly to the dressing should be clamped shut between the
dressing and the collection chamber, preferably at the collection
chamber end. Then, the pump and collection chamber should be
disconnected. If necessary, the collection chamber should be
emptied, and/or the proper sterilization procedures should be
performed; component 8, FIG. 31, represents a rubber plug, not
shown because integral floor 260 is utilized instead, for
increased access to the interior of the collection chamber in an
alternative construction. The pump should then be reset, and the
pump and collection chamber reconnected to the tube. Remove the
clamp to begin NPWT again. If a dressing change is also desired,
there is no need to use a clamp to keep the dressing sealed. Also,
if the collection chamber does not need to be emptied and/or
sterilized, then the tube should be clamped between the dressing
and the pump, preferably after the collection chamber if it is
separate from the pump at the pump end of the tube.  
  
[0152] An air leak test can be incorporated into the mechanical
pumps, except for the first (1) siphon concept. In the second (2)
siphon concept, the higher container is turned upside-down for the
initial air leak test. Most air leaks originate at the dressing
interfaces. In a purely mechanical pump, air leaks fill the
limited volume, causing the maximum time between pump resets to
decrease. To eliminate these air leaks and create a reliable,
repeatable therapy, devices according to the present disclosure
may include an air leak test. By using the air leak test, the
purely mechanical pumps have been proven to be capable of lasting
throughout the recommended timeframe between dressing changes (3
days). However, this test is not necessary for the occlusive seals
and dressings disclosed in this disclosure, but can provide a
visual reassurance to the caregiver and patient that the dressing
was applied properly and no significant leaks exist in the system.  
  
[0153] The air leak test is in the collection chamber. The tube
from the wound that enters into the collection chamber enters into
a wound compatible solution (such as saline). When applying the
NPWT, one should confirm that the end of the tube is submerged in
the solution and should look at the solution for air bubbles B,
FIGS. 31 and 32, (any air that initially exists in the tube may
create air bubbles; therefore, one should wait about 1-2 seconds
for additional air bubbles). If air bubbles are detected, the
dressing should be sealed until no air bubbles are detected. This
resealing may be to completely redress the wound, to smooth out
the air leaks in the current dressing, or to reinforce the current
dressing with additional dressing components. Once no air bubbles
are detected, the pump may need to be reset depending on how much
air entered into the pump.  
  
[0154] A safety feature of the collection chamber is to limit the
amount of liquid capable of being collected. If the collected
liquid were blood due to destruction of a vein or artery, there
exists a possibility that the patient may die due to fatal
bleeding. The collection chamber should be limited to less than
300cc of liquid to keep the patient at a safe range from possible
exsanguination. Therefore, if the pump design can pull more than
300cc of fluid, a safety feature should be implemented. If the
pump acts as the collection chamber, the safety feature should
limit its expansion volume. This can be done in various ways
through the introduction of limiting, internal (FIG. 31, component
6) and/or external (FIG. 31, component 7) structural components.
If an external collection chamber exists, then a safety feature
should stop the negative pressure after 300cc is collected. This
can be done by "plugging" the system with a mechanism, such as a
float-stop valve.  
  
[0155] Prior to the existence of a truly occlusive dressing, a
benefit in the external collection chamber was that the pump can
be larger than 300cc, and therefore, account for more air leaks
into the system. However, with a truly occlusive dressing, the
benefits include that the external collection chamber and its
fluids can be easily removed for lab testing purposes, and the
pump requires a less rigorous cleaning procedure between dressing
changes. However, these benefits are more readily solved with a
volume specific container with no rigidity, and containing no
initial volume of fluid that may contaminate a exudate sample, if
desired, that can be inserted into any of the mechanical pump
concepts disclosed in this disclosure, in order to collect the
fluid inside the pump body, acting as a collection liner instead
of a completely separate collection canister. The 300cc limitation
is recommended for the average adult; however, the limitation
volume may vary based on the patient. This volume variation can be
designed into multiple pump or collection chamber sizes, or into a
single, limit adjustable pump or collection chamber.  
  
[0156] Another pump safety feature is a one-way valve incorporated
in the tube between the wound and the collection chamber, such as
component 2, FIGS. 31 and 32. This mechanism assures that fluid
from the pump and collection chamber does not flow back into the
dressing. It also can be used as the tube clamping mechanism for
resetting the pump or emptying the collection chamber, depending
on placement in the tube. This mechanism can also be incorporated
into the tube connector on the collection chamber.  
  
[0157] Another mechanism that may be included is used to evacuate
the initial air found in the system after no air leaks are
detected. The current method is to clamp the tube near the pump
and to reset the pump until the initial air is evacuated from the
system. This can also be accomplished by including a one-way-
valve incorporated into the tube connector on the pump, such as
component 2, FIGS. 31 and 32, and another one-way-valve
incorporated between the interior cavity of the pump and
atmosphere, component 3, shown with a cap C in FIG. 31. With this
design, one can continue to compress (reset) the pump until the
desired vacuum is maintained; the system does not need to be
disconnected. The one-way-valve open to atmosphere can be capped
after therapy begins.   
  
[0158] This mechanism cannot be easily integrated to eliminate the
need for resetting the pump in the design that includes a rubber
balloon that is inserted into an orifice of an air-tight container
and the two siphon pumps. For the balloon design, a connection to
the container can be made to incorporate the attachment of a
separate pump with the oneway-valve and check valve design. This
pump can be attached for initial balloon inflation and container
evacuation, and then detached between dressing changes. In the two
siphon concepts, a pump can be attached to evacuate the space
above the column of fluid, raising the fluid level to the desired
height. The pump can be detached for extended therapy, between
dressing changes.  
  
[0159] An individual sealant component may be packaged by itself
to make any skin dressing occlusive. Alternatively, the sealant
can be packaged as part of a mechanical NPWT kit, including a
mechanical pump and its pre-attached components, tubing with
flexible foot and pre-attached tubing connector and optional one
way valve, dressing adhesive film to cover the packing material
(if necessary), the sealant material in a handheld spray
container, a wound packing material, and skin prep (if necessary).
Additionally, if there is an adhesive dressing tape-like film that
should be handled by the caregiver, then non-stick fingertip
covers maybe included for better adhesion outcomes. Non-powdered
gloves may also be included, so that the Van der Waals forces for
sealant attachment are not altered due to powder on the skin
surface. One skilled in the art would realize that kit components
may be swapped for their different functional embodiments,
discussed above. Also, additional components may be added or put
into additional kits that are used in typical dressing changes,
such as wound debridement tools, or additional wound therapies,
such as medications with their corresponding introduction and
(potentially) removal ports through the dressing, into the wound
cavity.  
  
[0160] As many dressing systems are identified in this disclosure,
one skilled in the art would realize that the liquid sealing
method can be used in combination with any tissue (a.k.a., skin)
dressing in order to create an air-tight seal. As many pumps are
identified in this disclosure, one skilled in the art would
realize that any pump combined with the occlusive dressing systems
would have similar performance characteristics.  
  
[0161] One technique according to the present invention for
constructing an occlusive dressing over a wound includes at least
one of (1) packing the wound with a fluid- pervious material and
(2) covering at least a portion of the wound with a protective
material. The method further includes applying, such as by
spraying, an organic material, preferably elastomeric, that is in
a liquid state, and is at least partially cross-linked at least
after one of drying and curing, over the packed material and onto
skin surrounding the wound to create an occlusive drape as a thin
sheet substantially impervious to fluid transfer, having a first,
inner surface and a second, outer surface. As utilized herein, the
term "organic material" includes matter in various forms that
include carbon atoms, including silicone rubbers. The method
includes at least one of drying and curing the elastomeric
material within thirty minutes after application of the
elastomeric material as a layer.  
  
[0162] FIG. 38 is a schematic top plan view of the wound shown in
FIG. 14, here with a cleaned skin zone indicated by dashed line
302 and with packing material 304, such as gauze or a sponge.
Additionally, a protective covering material 306 is applied over
the wound when intended liquid drape material has a sufficiently
lower viscosity and longer set time to be absorbed into the
packing material 304. Protective material 306 prevents liquid
drape material from flowing into the wound cavity. In some
constructions, protective material 306 is a solid impermeable or
semi-permeable polymeric sheet, which may be utilized with or
without adhesive. In other constructions, protective material 306
is a claylike substance that can be molded and packed over packing
material 304 and around a tube inserted into the packing material
304.  
  
[0163] FIG. 39 is a view of FIG. 38 with a hole 308 cut in the
protective covering 306, if an opening in the protective covering
306 has not already been formed or maintained.  
  
[0164] FIG. 40 is a view of FIG. 39 with a tube assembly 27c, with
tube 24c and flange 26c, having sleeve 52d, rotation region 54d
and adhesion region 56d, placed over the hole 308. Tube assembly
27c is maintained in position with adhesive in some techniques
and, in other techniques, is manually held in place.
Alternatively, tube 24c can directly puncture protective covering
306 such that covering 306 maintains a tight seal around tube 24c,
potentially with an additional seal barrier such as clay or
adhesive. In another construction, flange 26c is sufficiently
large in diameter to completely cover the wound.  
  
[0165] FIG. 41 is a view of FIG. 40 with liquid drape material 310
applied over the protective covering 306 and onto surrounding skin
SK to cover skin zone 302 to thereby construct a dressing
according to the present invention. The liquid drape material 310
is applied by spraying or application technique such that material
310 firmly attaches to skin SK surrounding the wound and covers
any protective cover layer 306, if utilized, as well as creating
an air-tight seal around flange 26d. FIG. 42 is a schematic
perspective view of the dressing of FIG. 41 In other
constructions, the drape is constructed directly onto a tube
without utilizing a separate flange.  
  
[0166] FIG. 43 is a schematic perspective view of a novel flange
26d according to the present invention with integral connector 320
having a barb-type engagement feature 322 defining passage 324.
Engagement feature 322 is insertable into end of a tube.  
  
[0167] Although specific features of the present invention are
shown in some drawings and not in others, this is for convenience
only, as each feature may be combined with any or all of the other
features in accordance with the invention. While there have been
shown, described, and pointed out fundamental novel features of
the invention as applied to one or more preferred embodiments
thereof, it will be understood that various omissions,
substitutions, and changes in the form and details of the devices
illustrated, and in their operation, may be made by those skilled
in the art without departing from the spirit and scope of the
invention. For example, it is expressly intended that all
combinations of those elements and/or steps that perform
substantially the same function, in substantially the same way, to
achieve the same results be within the scope of the invention.
Substitutions of elements from one described embodiment to another
are also fully intended and contemplated. It is also to be
understood that the drawings are not necessarily drawn to scale,
but that they are merely conceptual in nature. It is the
intention, therefore, to be limited only as indicated by the scope
of the claims appended hereto. Other embodiments will occur to
those skilled in the art and are within the following claims.  
  


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[**http://en.wikipedia.org/wiki/Negative-pressure\_wound\_therapy**](http://en.wikipedia.org/wiki/Negative-pressure_wound_therapy)

**Negative-pressure wound therapy**

  
Application of a vacuum pump using a foam dressing to a wound  
  
Negative-pressure wound therapy (NPWT) is a therapeutic technique
using a vacuum dressing to promote healing in acute or chronic
wounds and enhance healing of first and second degree burns. The
therapy involves the controlled application of sub-atmospheric
pressure to the local wound environment,[1] using a sealed wound
dressing connected to a vacuum pump.[2][3] The use of this
technique in wound management increased dramatically over the
1990s and 2000s[4] and a large number of studies have been
published examining NPWT.[5] NPWT appears to be useful for
diabetic ulcers[6] and management of the open abdomen (laparotomy)
[7] but further research is required for other wound types.[8]  
  
**Overview**  
NPWT promotes wound healing by applying a vacuum through a special
sealed dressing. The continued vacuum draws out fluid from the
wound and increases blood flow to the area.[2] The vacuum may be
applied continuously or intermittently, depending on the type of
wound being treated and the clinical objectives. Typically, the
dressing is changed two to three times per week.[3] The dressings
used for the technique include open-cell foam dressings and gauze,
sealed with an occlusive dressing intended to contain the vacuum
at the wound site.[1] Where NPWT devices allow delivery of fluids,
such as saline or antibiotics to irrigate the wound,[9][10]
intermittent removal of used fluid supports the cleaning and
drainage of the wound bed.[11]  
  
In 1995, Kinetic Concepts was the first company to have a NPWT
product cleared by the US Food and Drug Administration.[12]
Following increased use of the technique by hospitals in the US,
the procedure was approved for reimbursement by the Centers for
Medicare and Medicaid Services in 2001.[1]  
  
**Technique**  
General technique for NPWT is as follows: a dressing or filler
material is fitted to the contours of a wound (which is covered
with a non-adherent dressing film) and the overlying foam is then
sealed with a transparent film. A drainage tube is connected to
the dressing through an opening of the transparent film. A vacuum
tube is connected through an opening in the film drape to a
canister on the side of a vacuum pump.[13] or vacuum source,
turning an open wound into a controlled, closed wound[2] while
removing excess fluid from the wound bed to enhance circulation
and remove wound fluids. This creates a moist healing environment
and reduces edema.[5][13] The technique is usually used with
chronic wounds or wounds that are expected to present difficulties
while healing (such as those associated with diabetes).[3]  
  
Three types of filler material are used over the wound surface:
open-cell foam, gauze and transparent film, or honeycombed
textiles with a dimpled wound contact surface.  
  
Foam dressings are used to fill open cavity wounds and can be cut
to size to fit wounds. The foam dressing is applied, filling the
wound and then a film drape is applied over the top to create a
seal around the dressing.  
  
Open weave cotton gauze can be covered with a transparent film,
and a flat drain is sandwiched in gauze and placed onto the wound.
The film drape covers the wound and create a complete seal, and
then the drain is connected to the pump via the tubing.[14]  
  
Layers of non-woven polyester, joined by a silicone elastomer, has
a non-adherent wound contact surface made up of numerous small
semi-rigid dome structures,[15] though this solution has not
completed a clinical trial as of December 2012.[16]  
  
With all three techniques, once the dressing is sealed the vacuum
pump can be set to deliver continuous or intermittent pressures,
with levels of pressure depending on the device used,[13][14][17]
varying between a125 and a75 mmHg depending on the material used
and patient tolerance.[15][18] Pressure can be applied constantly
or intermittently.[13]  
  
The dressing type used depends on the type of wound, clinical
objectives and patient. For pain sensitive patients with shallow
or irregular wounds, wounds with undermining or explored tracts or
tunnels, gauze may be used, while foam may be cut easily to fit a
patientas wound that has a regular contour and perform better when
aggressive granulation formation and wound contraction is the
desired goal.[19]  
Effectiveness  
  
A 2007 Cochrane Review stated that the evidence comparing NPWT to
alternative care was flawed and required more study, but the
evidence did support improved healing and called for more, better
quality research to be conducted.[8] A 2010 systematic review
found "consistent evidence of the benefit of NPWT" in the
treatment of diabetic ulcers of the feet. Results for bedsores was
"conflicting" and research on "mixed wounds" was of poor quality,
but promising. The review did not find evidence of increased
significant complications. The review concluded "There is now
sufficient evidence to show that NPWT is safe, and will accelerate
healing, to justify its use in the treatment of
diabetes-associated chronic leg wounds. There is also evidence,
though of poor quality, to suggest that healing of other wounds
may also be accelerated."[6]  
  
**References**  
a b c Lillis, Karin (2003). "Effective wound care requires look at
total patient picture". Healthcare Purchasing News 27 (1): 32.
ISSN 0279-4799   
  
a b c Moody, Yasmeen (19 July 2001). "Advances in healing chronic
wounds". The Ithaca Journal (Ithaca, NY). p. 10A   
  
a b c Fogg, Erich (27 August 2009). "Best treatment of nonhealing
and problematic wounds". Journal of the American Academy of
Physician Assistants 22 (8): 46, 48. PMID 19725415.  
  
Driscoll, P (24 October 2009). "Negative Pressure Wound Therapy
(Gauze and Foam)". Advanced Medical Technologies   
  
a b Gupta, Subhas; Bates-Jensen, Barbara; Gabriel, Allen;
Holloway, Allen; Niezgoda, Jeffrey; Weir, Dot (2007).
"Differentiating Negative Pressure Wound Therapy Devices: An
Illustrative Case Series". Wounds 19 (1 (Supplement)): 1a9   
  
a b Xie, X.; McGregor, M.; Dendukuri, N. (November 2010). "The
clinical effectiveness of negative pressure wound therapy: a
systematic review". Journal of Wound Care 19 (11): 490a5. PMID
21135797.  
  
Fitzgerald JEF, Gupta S, Masterson S, Sigurdsson HH. Laparotomy
Management using the ABTheraacent Open Abdomen Negative Pressure
Therapy System in a Grade IV Open Abdomen Secondary to Acute
Pancreatitis. International Wound Journal 2012. PMID 22487377  
  
a b Ubbink, Dirk T; Westerbos, Stijn JoA<<l; Evans, Debra; Land,
Lucy; Vermeulen, Hester (2008). "Topical negative pressure for
treating chronic wounds". In Ubbink, Dirk T. Cochrane Database of
Systematic Reviews 16 (3): CD001898.
doi:10.1002/14651858.CD001898.pub2. PMID 18646080.  
  
Gerry R, Kwei S, Bayer L, Breuing KH (July 2007).
"Silver-impregnated vacuum-assisted closure in the treatment of
recalcitrant venous stasis ulcers". Ann Plast Surg. 59 (1): 58a62.
doi:10.1097/01.sap.0000263420.70303.cc. PMID 17589262   
  
Wendling, Patrice (April 2008). "Vacuum-assisted wound therapy
uses expanded". Skin & Allergy News. Retrieved 11 January 2011
  
  
Moch D, Fleischmann W, Westhauser A (1998).
"Instillationsvakuumversiegelung: ein erster Erfahrungsbericht"
[Instillation vacuum sealingareport of initial experiences].
Langenbecks Archiv fA1/4r Chirurgie (in German) 115: 1197a9. PMID
9931834.  
  
"Vacuum Assisted Closure Wound Therapy Cleared for Partial
Thickness Burns". Reuters Health Medical News. January 27, 2003.   
  
a b c d Baxter, Helena; Ballard, Kate (2001). "Vacuum-Assisted
Closure". Nursing Times 97 (35): 51a2. PMID 11957602. Retrieved 11
January 2011.  
  
a b Miller, Michael S.; Brown, Rhonda; McDaniel, Cheryl (1
September 2005). "Negative pressure wound therapy options promote
patient care". Biomechanics. p. 49.  
  
 a b Glat, Paul (8 July 2010). "The use of negative pressure
wound therapy with Bio-Domeacent dressing technology". Today's Wound
Clinic. Retrieved 20 January 2011.[unreliable medical source?]  
  
http://clinicaltrials.gov/show/NCT01107821  
  
Michael S., Miller (February 2009). "Multiple approaches offer
negative pressure options". Biomechanics.  
  
Morykwas, Michael J.; Argenta, Louis C.; Shelton-Brown, Erica I.;
McGuirt, Wyman (1997). "Vacuum-assisted closure: a new method for
wound control and treatment". Annals of Plastic Surgery 38 (6):
553a62. doi:10.1097/00000637-199706000-00001. PMID 9188970.  
  
Long, Mary Arnold; Blevins, Anne (2009). "Options in negative
pressure wound therapy". Journal of Wound, Ostomy and Continence
Nursing 36 (2): 202a11. doi:10.1097/01.WON.0000347664.10217.2e.  
  


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[**https://www.ecri.org/Documents/Press%20Releases/Negative\_Pressure\_Wound\_Therapy\_Devices.pdf**](https://www.ecri.org/Documents/Press%20Releases/Negative_Pressure_Wound_Therapy_Devices.pdf)  

**Agency for Healthcare Research and Quality
  
Technology assessment: negative-pressure wound therapy devices**

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 [**http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm225038.htm**](http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm225038.htm)

**(Article reprinted from** ***Nursing2010*****,
September issue, p.64-66.)**

**Negative pressure wound
therapy: Use with care**

By Nasrin Mirsaidi, MSN, RN, CNOR

NEGATIVE Pressure wound therapy (NPWT) is used to treat acute and
chronic wounds. A vacuum source creates continuous or intermittent
negative pressure inside the wound to remove fluid, exudates, and
infectious materials to prepare the wound for healing and closure.1NPWT systems consist of a vacuum pump, drainage tubing, a
foam or gauze wound dressing, and an adhesive film dressing that
covers and seals the wound.

Since 1997, when the first device indicated for NPWT was
cleared by the FDA for marketing in the United States, the
system has evolved considerably. New device and dressing
features have been added that make the system safer, more
efficient, and more user-friendly in care settings other than
hospitals, such as in long-term care facilities, rehab centers,
and even patientsa homes.

Although many patients have benefited from NPWT, adverse events
a including deaths and serious injuries a have been reported to
the FDA. The following is a case example:

An older adult underwent bilateral femoral endarterectomy for
severe peripheral arterial disease. About 1 week after the
procedure, the patient required surgery for wound exploration
and evacuation of blood clots and then was diagnosed with an
infection of the right groin incision. An NPWT system was
applied to the wound and the patient was discharged home on
antibiotic and coagulation therapy.

Ten days later, the patient experienced a massive hemorrhage
from the right groin wound. When paramedics arrived at the home,
they provided basic life and advanced cardiovascular life
support. After transport to the ED, the patient was pronounced
dead. The cause of death was exsanguination.

**What went wrong?**

The most serious adverse events associated with NPWT, blood
loss and infection, can be prevented if healthcare professionals
pay close attention to:

Device labeling, including warnings, instructions for use,
indications, and contraindications.

Criteria for patient selection, wound type, and appropriate
care setting based on each patientas needs.

**What precautions can you take?**

These strategies are recommended to prevent complications:

***Patient selection and wound type.***

Patients should be thoroughly evaluated for bleeding risk. The
patient in the case example had several risk factors for
bleeding, including history of postoperative blood clots in the
wound, anticoagulation therapy, and wound infection. Besides
being at high risk for infection, groin wounds are also prone to
delayed wound closure due to hip joint movement.

***High-risk patients and selection of care setting.***

NPWT should be used in an appropriate healthcare setting based
on the patientas need for monitoring and wound care. At high
risk for bleeding and infection, this patient should have been
in a healthcare facility where healthcare professionals are
available around the clock.

***Wound care-specific considerations.***

Many reported adverse events are the result of inappropriate
methods of dressing change. For instance, bleeding can occur
from improper removal of dressings that have adhered to or are
imbedded in the tissues. Bleeding can also occur if the dressing
is applied directly to exposed or superficial vessels in or
around the wound that havenat been completely covered and
protected as recommended by the device manufacturer before
initiating NPWT.

Wound infections may develop if pieces of dressing are retained
in the wound. To prevent this complication, device instructions
recommend counting the total number of dressing pieces used in
the wound and documenting that number on the outer adhesive film
dressing and in the patientas medical record. Teach the
caregiver to count the number of dressing pieces removed to make
sure that all pieces are accounted for.

***Training of healthcare providers, patients, and
caregivers.***

Healthcare providers using NPWT devices should undergo
appropriate training on device use, including its indications
and contraindications, and recognition and management of
potential complications.

NPWT training for patients and their caregivers who will be
using the device at home should include how to:

Safely operate the device; provide a copy of printed
instructions for patient use from the specific device
manufacturer

Respond to audio and visual alarms

Perform dressing changes

Recognize signs and symptoms of complications, such as redness,
warmth, and pain associated with possible infection

Contact appropriate healthcare providers, especially in
emergency situations

Respond to emergency situations; for instance, if bright red
blood is seen in the tubing or canister, to immediately stop
NPWT, apply direct manual pressure to the dressing, and activate
emergency medical services.

Use return demonstrations to evaluate patientsa and caregiversa
skills and comprehension of training materials.

On November 13, 2009, the FDA published a preliminary public
health notification on the use of NPWT systems. It will be
updated according to findings of an ongoing investigation.
Please review the links below for further details. You play an
important role in keeping your patients safe when using NPWT.

**[http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/
ucm190658.htm](http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm190658.htm)**

**<http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm190476.htm>**

**<http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm193277.htm>**

**REFERENCE**

1. Agency for Healthcare Research and Quality. Technology
assessment: negative-pressure wound therapy devices. 2009.   
  
**<https://www.ecri.org/Documents/Press%20Releases/Negative_Pressure_Wound_Therapy_Devices.pdf>**  


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[**http://www.journalofwoundcare.com/cgi-bin/go.pl/library/article.html?uid=79697;article=JWC\_19\_11\_490**](http://www.journalofwoundcare.com/cgi-bin/go.pl/library/article.html?uid=79697;article=JWC_19_11_490)**Journal of Wound Care, Vol. 19, Iss. 11, 10 Nov 2010, pp
490 - 495**

**The clinical effectiveness of negative
pressure wound therapy: a systematic review**  
**X. Xie, M. McGregor, N. Dendukuri**

  
Objective: To estimate the efficacy of negative pressure wound
therapy (NPWT), on the basis of a systematic review of reported
randomised controlled trials (RCTs).  
  
Method: A systematic literature search for relevant RCTs was
carried out. The credibility of the outcome of each study was
evaluated using a specially constructed instrument.  
  
Results: We identified 17 RCTs, of which five had not been
included in previous reviews or health technology assessments. For
diabetic foot ulcers (seven RCTs), there was consistent evidence
of the benefit of NPWT compared with control treatments. For
pressure ulcers (three RCTs), results were conflicting. In trials
involving mixed wounds (five RCTs), evidence was encouraging but
of inadequate quality. Significant complications were not
increased.  
  
Conclusion: There is now sufficient evidence to show that NPWT is
safe, and will accelerate healing, to justify its use in the
treatment of diabetes-associated chronic leg wounds. There is also
evidence, though of poor quality, to suggest that healing of other
wounds may also be accelerated.   
  


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