U.S. patent application number 12/688485 was filed with the patent office on 2010-05-13 for wound care system.
This patent application is currently assigned to Pioneer Technology LLC. Invention is credited to Thomas G. Andrews, David P. Bohman, Jack Fisher, Robert Stephen Porter, David Myron Smith, Joshua David Smith.
Application Number | 20100121287 12/688485 |
Document ID | / |
Family ID | 37890180 |
Filed Date | 2010-05-13 |
United States Patent
Application |
20100121287 |
Kind Code |
A1 |
Smith; Joshua David ; et
al. |
May 13, 2010 |
WOUND CARE SYSTEM
Abstract
Disclosed is an apparatus for the treatment of a wound on a
patient. The apparatus is capable of administering localized
negative pressure therapy to the wound using a negative pressure
source and a drain line for removing exudate from the wound. The
apparatus is also capable of administering localized hyperbaric
fluid therapy to the wound using a fluid source and a supply line
for supplying fluid to the wound.
Inventors: |
Smith; Joshua David;
(Nashville, TN) ; Smith; David Myron; (Burns,
TN) ; Andrews; Thomas G.; (Nashville, TN) ;
Fisher; Jack; (Nashville, TN) ; Bohman; David P.;
(Nashville, TN) ; Porter; Robert Stephen;
(Brentwood, TN) |
Correspondence
Address: |
RENNER OTTO BOISSELLE & SKLAR, LLP
1621 EUCLID AVENUE, NINETEENTH FLOOR
CLEVELAND
OH
44115
US
|
Assignee: |
Pioneer Technology LLC
Nashville
TN
|
Family ID: |
37890180 |
Appl. No.: |
12/688485 |
Filed: |
January 15, 2010 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
11602653 |
Nov 21, 2006 |
7648488 |
|
|
12688485 |
|
|
|
|
60738690 |
Nov 21, 2005 |
|
|
|
Current U.S.
Class: |
604/319 |
Current CPC
Class: |
A61M 2205/3344 20130101;
A61M 2205/3592 20130101; A61M 35/30 20190501; A61B 5/145 20130101;
A61F 2013/0097 20130101; A61F 2013/0017 20130101; A61M 2205/3561
20130101; A61B 5/445 20130101; A61M 1/0088 20130101; A61M 1/0084
20130101 |
Class at
Publication: |
604/319 |
International
Class: |
A61M 1/00 20060101
A61M001/00 |
Claims
1. A wound treatment apparatus comprising: a drain line configured
for attachment to a negative pressure source and for removing
exudate from the wound; a supply line configured for attachment to
a fluid source and for supplying fluid to the wound; a controller
configured to: cause negative pressure therapy to be administered
to the wound via the drain line, and cause hyperbaric fluid therapy
to be administered to the wound via the supply line for
approximately 10 seconds to approximately 60 seconds.
2. The wound treatment apparatus of claim 1, wherein the controller
is further configured to selectively cause the administration of
only negative pressure therapy or only hyperbaric fluid
therapy.
3. The wound treatment apparatus of claim 1, wherein the drain line
is configured for attachment to a hospital room suction line.
4. The wound treatment apparatus of claim 1, wherein the supply
line is configured for attachment to a hospital room oxygen
line.
5. The wound treatment apparatus of claim 1 further comprising a
humidification device operatively connected to the supply line.
6. The wound treatment apparatus of claim 1, further comprising a
negative pressure source and the fluid source.
7. The wound treatment apparatus of claim 6, wherein the fluid
source is an oxygen canister.
8. The wound treatment apparatus of claim 6, wherein the negative
pressure source and fluid source share a power supply.
9. The wound treatment apparatus of claim 6, wherein the fluid
source is configured to supply a constant flow of fluid and the
controller is configured to cause the negative pressure source to
operate intermittently such that negative pressure therapy is
administered to the wound when the negative pressure source is on
and hyperbaric fluid therapy is administered to the wound when the
negative pressure source is off.
10. The wound treatment apparatus of claim 1, further comprising a
pressure sensor to measure pressure at the wound.
11. The wound treatment apparatus of claim 10, wherein the pressure
sensor is operatively connected to the controller and the
controller is further configured to adjust at least one of the
negative pressure therapy or the hyperbaric fluid therapy in
response to information received from the pressure sensor.
12. The wound treatment apparatus of claim 1 wherein the controller
is further configured to selectively cause the cessation of one of
the negative pressure therapy or the hyperbaric fluid therapy
without causing the cessation of the other of the negative pressure
therapy or the hyperbaric fluid therapy.
13. The wound treatment apparatus of claim 1, further comprising a
collection device operatively connected to the drain line to
collect exudate from the wound.
14. The wound treatment apparatus of claim 13, wherein the
collection device comprises a sensor for indicating the amount of
exudate in the collection device.
15. The wound treatment apparatus of claim 14, wherein the
collection device sensor is operatively connected to the controller
and the controller is further configured to stop the administration
of negative pressure therapy upon receiving information from the
collection device sensor indicating that the collection device is
full.
16. The wound treatment apparatus of claim 1, further comprising a
mechanical pressure regulator connected to the supply line.
17. A portable wound treatment apparatus comprising: a negative
pressure source configured for operative engagement with a wound
dressing via a drain line; a fluid source configured for operative
engagement with a wound dressing via a supply line; a controller
configured to: cause negative pressure therapy to be administered
to the wound, and cause hyperbaric fluid therapy to be administered
to the wound for approximately 10 seconds to approximately 60
seconds; and a housing configured to house the negative pressure
source, the fluid source and the controller.
18. The portable wound treatment apparatus of claim 17, further
comprising a power source for supplying power to at least one of
the negative pressure source and the fluid source, wherein the
housing is further configured to house the power source.
19. The portable wound treatment apparatus of claim 18, wherein the
fluid source is an oxygen concentrator, the negative pressure
source is suction device and the power source is a rechargeable
battery.
20. A method for treating a wound comprising: applying to the wound
a dressing that engages a supply line and a drain line; connecting
the supply line to a fluid source; connecting the drain line to a
negative pressure source; administering negative pressure therapy
to the wound via the drain line; and administering hyperbaric fluid
therapy to the wound for approximately 10 to approximately 60
seconds.
21. The method of claim 20, wherein the negative pressure therapy
and the hyperbaric fluid therapy are administered
intermittently.
22. The method of claim 20, wherein negative pressure therapy is
administered immediately following the administration of hyperbaric
fluid therapy and hyperbaric fluid therapy is administered
immediately following the administration of negative pressure
therapy.
23. The method of claim 20, wherein administering hyperbaric fluid
therapy comprises supplying fluid to the wound wherein the fluid
comprises at least one of: oxygen or humidified oxygen.
24. The method of claim 23, wherein the oxygen or humidified oxygen
is administered at approximately 0.1 liters per minute to
approximately 3 liters per minute.
25. The method of claim 20, wherein administering hyperbaric fluid
therapy comprises supplying fluid to the wound, wherein the fluid
comprises at least one non-oxygen drug.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This application is a continuation application of U.S.
application Ser. No. 11/602,653 filed on Nov. 21, 2006, entitled
"Wound Care System" which claims priority from U.S. Provisional
Patent Application Ser. No. 60/738,690 filed on Nov. 21, 2005,
entitled "Pioneer Hyperbaric Closed Suction Wound Drainage System,"
both of which are hereby incorporated by reference.
BACKGROUND OF THE INVENTION
[0002] The present invention relates generally to wound care
treatment and systems for treating wounds. More specifically, the
present invention relates to a system designed for alternating
applications of vacuum and hyperbaric wound treatments to a wound
site.
[0003] The patient care industry is continually searching to
provide better services, reduce costs, and improve the equipment
used to provide the best possible care to the patients. One such
way to advance patient care is to improve the treatment of chronic
and acute wounds and various types of therapies to treat these
wounds. One of two types of treatments is often used to treat
chronic and acute wounds: negative pressure therapy or hyperbaric
oxygen therapy.
[0004] Negative pressure therapy is the controlled application of
sub-atmospheric pressure to a wound using a therapy unit, such as a
vacuum or suction device, to expose a wound to negative pressure to
help promote wound healing. The wound is typically covered to
facilitate this negative pressure and suction at the wound area.
Various types of resilient, open cell foam surface dressings are
typically sealed within an adhesive drape to provide the
sub-atmospheric pressure at the wound site. The exudates drained
from the wound site are normally directed to a canister that stores
the fluids and/or infectious material until properly disposed. The
negative pressure wound therapy has been typically prescribed for
chronic and acute wound types such as diabetic wounds, pressure
ulcers, abdominal wounds, trauma wounds, various burns, flaps and
grafts. One of the limitations of negative pressure therapy is that
it may be less effective on patients with vascular disorders, such
as diabetes, particularly because negative pressure therapy creates
a hypoxic environment at the wound. Current research indicates that
wound healing is impaired when the oxygen level is 30 millimeters
of mercury (mmHg) or less.
[0005] Hyperbaric oxygen therapy is the controlled application of
greater-than-atmospheric pressures of oxygen to a wound. Oxygen is
typically required for all new cell growth, and chronic or
nonhealing wounds tend to exhibit low oxygen tensions, or tend to
be ischemic. A wound can become dormant if the amount of wound
tissue that is poorly oxygenated reaches a critical mass. In this
state, the body may no longer recognize the need to heal that area,
which exacerbates the lack of oxygen in that wound and thus
substantially prevents healing of the wound by the body. Oxygen
therapy is particularly useful for patients with poor circulation.
In addition to helping kill bacteria, oxygen applied to an open
wound at a hyperbaric level is dissolved into the wound and
absorbed by the surface wound tissue. The cells of the wound tissue
that absorb the oxygen will begin metabolic activity in response to
the increased oxygen tension. Once the oxygen source is removed,
the previously active cells request more oxygen from the body. The
body responds by beginning to form new blood cells, and thus,
starting the healing process.
[0006] Typically, hyperbaric oxygen therapy is performed by placing
the patient into a hyperbaric chamber that encompasses the full
body of the patient or an entire extremity, such as a leg or an
arm. Such chambers are problematic due to their lack of
portability, the difficulty in sterilization of the chambers
between patients, and the potential adverse effects of breathing
oxygen at hyperbaric pressure. It would be preferable if the
hyperbaric oxygen treatment were localized at the wound rather than
applied to the patient's entire body or extremity.
[0007] While both negative pressure and hyperbaric oxygen therapies
are each believed to be effective when administered as separate
wound care treatments, many patients may benefit from a treatment
plan incorporating both negative pressure and hyperbaric oxygen
therapies. Because existing hyperbaric oxygen treatment is
typically performed in a hyperbaric chamber, switching between
negative pressure therapy and hyperbaric oxygen therapy is a long
process. Before entering a hyperbaric oxygen chamber, a patient
would first have to be disconnected from the negative therapy
device and the negative pressure therapy dressing--which typically
includes packing materials, a drain, tubing, and sealing
material--would have to be removed. Then, following hyperbaric
oxygen treatment, a new negative pressure dressing would have to be
applied. These procedures are wasteful and time-consuming, making
it difficult, if not impossible, to alternate between negative
pressure therapy and hyperbaric oxygen therapy every few minutes or
less.
[0008] It would be preferable if an apparatus were capable of
localized alternating administration of negative pressure and
hyperbaric oxygen therapies to treat a single wound without
requiring a change of dressing.
BRIEF SUMMARY OF THE INVENTION
[0009] Disclosed is an apparatus for the treatment of a wound on a
patient. The apparatus includes a drain line configured for
attachment to a negative pressure source and for removing exudate
from the wound; a supply line configured for attachment to a fluid
source and for supplying fluid to the wound; and a controller. The
controller is configured to cause negative pressure therapy to be
administered to the wound via the drain line. The controller is
further configured to cause hyperbaric fluid therapy to be
administered to the wound via the supply line.
[0010] The controller is further configured to cause hyperbaric
fluid therapy to be administered to the wound at an absolute
pressure of at least approximately 1.5 atmospheres via the supply
line.
[0011] Also disclosed is a wound treatment apparatus that includes
a drain line configured for attachment to a negative pressure
source and for removing exudate from the wound. The apparatus
further includes a supply line configured for attachment to a fluid
source and for supplying fluid to the wound and a controller. The
controller is configured to cause negative pressure therapy to be
administered to the wound for a first time period via the drain
line, and cause hyperbaric fluid therapy to be administered to the
wound for a second time period via the supply line, wherein the
first time period is approximately two to three times as long as
the second time period.
[0012] Also disclosed is a portable wound treatment apparatus. The
portable wound treatment apparatus includes a negative pressure
source configured for operative engagement with a wound dressing
via a drain line and a fluid source configured for operative
engagement with a wound dressing via a supply line. The apparatus
also includes a controller that is configured to cause negative
pressure therapy to be administered to the wound, and also to cause
hyperbaric fluid therapy to be administered to the wound at an
absolute pressure of at least approximately 1.5 atmospheres. The
apparatus further includes a housing configured to house the
negative pressure source, the fluid source and the controller.
[0013] Further disclosed is a portable wound treatment apparatus
including a negative pressure source configured for operative
engagement with a wound dressing via a drain line. The apparatus
also includes a fluid source configured for operative engagement
with a wound dressing via a supply line, a controller and a housing
configured to house the negative pressure source, the fluid source
and the controller. The controller is configured to cause negative
pressure therapy to be administered for a to the wound first time
period, and cause hyperbaric fluid therapy to be administered to
the wound for a second time period, wherein the first time period
is approximately two to three times as long as the second time
period.
[0014] Also disclosed is a wound treatment apparatus comprising
including a drain line configured for attachment to a negative
pressure source and for removing exudate from the wound and a
supply line configured for attachment to a fluid source and for
supplying fluid to the wound. The apparatus further includes a
controller that is configured to cause negative pressure therapy to
be administered to the wound via the drain line, and to cause
hyperbaric fluid therapy to be administered to the wound at via the
supply line. The controller is further configured to control the
administration of negative pressure therapy and hyperbaric fluid
therapy such that the administration of negative pressure therapy
and hyperbaric fluid therapy is cyclical and the hyperbaric fluid
therapy is administered to the wound for no more than 30 minutes
during each cycle.
[0015] Also disclosed is a method for treating a wound. The method
includes applying to the wound a dressing that engages a supply
line and a drain line; connecting the supply line to a fluid
source; connecting the drain line to a negative pressure source;
administering negative pressure therapy to the wound via the supply
line; and administering hyperbaric fluid therapy to the wound at an
absolute pressure of at least 1.5 atmospheres via the supply
line.
[0016] Further disclosed is another method for treating a wound.
The method includes applying to the wound a dressing that engages a
supply line and a drain line; connecting the supply line to a fluid
source; connecting the drain line to a negative pressure source;
administering negative pressure therapy to the wound via the drain
line for a first time period; and administering hyperbaric fluid
therapy to the wound via the supply line for a second time period.
The first time period is approximately two to three times as long
as the second time period.
[0017] Also disclosed is a method for treating a wound comprising:
applying to the wound a dressing that engages a supply line and a
drain line; connecting the supply line to a fluid source;
connecting the drain line to a negative pressure source;
administering negative pressure therapy to the wound via the drain
line for a first time period; following the administration of
negative pressure therapy, administering hyperbaric fluid therapy
to the wound via the supply line for no more than 30 minutes; and
following the administration of hyperbaric fluid therapy,
administering negative pressure therapy to the wound via the drain
line.
[0018] The negative pressure therapy and hyperbaric fluid therapy
may be administered intermittently.
[0019] The fluid source may be configured to supply a constant flow
of fluid such that the administration of negative pressure therapy
is accomplished by activating the negative pressure source and the
administration of hyperbaric fluid therapy is accomplished by
deactivating the negative pressure source.
[0020] The administration of negative pressure therapy may also be
accomplished by activating the negative pressure source and
reducing the flow of fluid from the fluid source. Similarly, the
administration of hyperbaric fluid therapy may be accomplished by
deactivating the negative pressure source and increasing the flow
of fluid from the hyperbaric fluid source.
[0021] The administration of negative pressure therapy and
hyperbaric fluid therapy may also be adjusted in response to
information received from a sensor, such as a diffusion sensor,
that measures tissue conditions at the wound.
[0022] In addition, the disclosed apparatus may also include either
mechanical or electronic pressure regulation to ensure that the
pressures applied to the wound site do not exceed a desired
level.
[0023] Also disclosed is a method for preparing a wound dressing.
The method includes inserting packing material into the wound;
inserting open ends of a supply line and a drain line into the
wound; molding a pliable adhesive around the perimeter of the wound
such that the adhesive separates the supply line from the skin
surrounding the wound and such that the adhesive separates the
drain line from the skin surrounding the wound; molding another
piece of pliable adhesive over the supply line and the drain line;
and placing sealing material over the wound, the packing material,
the supply line, the drain line and the adhesive such that the
sealing material adheres to both the adhesive and the skin
surrounding the adhesive.
[0024] It is therefore a general object of the present invention to
provide an improved apparatus for the treatment of wounds.
[0025] Another object of the present invention is to provide an
apparatus that provides both negative pressure therapy and
hyperbaric fluid therapy to a wound site.
[0026] These and further features of the present invention will be
apparent with reference to the following description and attached
drawings. In the description and drawings, particular embodiments
of the invention have been disclosed in detail as being indicative
of some of the ways in which the principles of the invention may be
employed, but it is understood that the invention is not limited
correspondingly in scope. Rather, the invention includes all
changes, modifications and equivalents coming within the spirit and
terms of the claims appended hereto.
[0027] Features that are described and/or illustrated with respect
to one embodiment may be used in the same way or in a similar way
in one or more other embodiments and/or in combination with or
instead of the features of the other embodiments.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0028] FIG. 1 is a schematic view of an apparatus made in
accordance with the current disclosure;
[0029] FIG. 2 is a schematic illustration of an example wound
dressing and surrounding elements made in accordance with the
current disclosure;
[0030] FIG. 3 is a schematic illustration of a hospital bed
embodiment of apparatus made in accordance with the current
disclosure;
[0031] FIG. 4 is an embodiment of a portable apparatus made in
accordance with the current disclosure positioned on a wound;
[0032] FIG. 5 is an alternate embodiment of an apparatus made in
accordance with the current disclosure positioned on a wound;
[0033] FIG. 6 is a side view of a wound being treated by an
apparatus made in accordance with the current disclosure and using
an embodiment of a drain made in accordance with the current
disclosure;
[0034] FIG. 7 is top view of a wound being treated using the drain
of FIG. 6;
[0035] FIG. 8 is a view of the drain of FIGS. 6 and 7;
[0036] FIG. 9 is an embodiment of the supply and drain lines made
in accordance with the current disclosure;
[0037] FIGS. 10A-F illustrate the preparation of a wound dressing
made in accordance with the current disclosure; and
[0038] FIG. 11 is a flow chart illustrating a method performed in
accordance with the current disclosure.
DETAILED DESCRIPTION OF THE INVENTION
[0039] The invention relates to a novel therapeutic method and
apparatus capable of administering both negative pressure therapy
and hyperbaric fluid therapy for wound healing. Preferably,
negative pressure therapy and hyperbaric fluid therapy, such as
hyperbaric oxygen, are intermittently applied to the wound area to
remove exudate from the wound and to infuse oxygen into the wound.
It is believed that the controlled application of these therapies
can greatly increase wound healing success, both clinically and
aesthetically, and minimize wound healing time
[0040] The apparatus includes a drain line that attaches to a
negative pressure source and is used to remove exudate from the
wound. The apparatus also includes a supply line that attaches to a
fluid source, such as an oxygen source, and is used to supply fluid
to the wound under positive pressure. The system further includes a
controller that controls the administration of negative pressure
therapy via the drain line and the administration of hyperbaric
fluid therapy via the supply line. The apparatus is thus capable of
alternating between negative pressure therapy and hyperbaric fluid
therapy in an automated manner without requiring clinician
assistance and without necessitating a wound dressing change.
Moreover, the apparatus can also be made portable because it
provides localized therapy without requiring a chamber encompassing
a patient's entire body or extremity.
[0041] Monitoring of the therapy results, such as monitoring of
oxygen levels at the wound site or monitoring of exudate removal,
allows the wound treatment therapy to be tailored to each
individual to maximize the therapeutic effect while minimizing
therapy duration.
[0042] Referring generally now to FIG. 1, a wound treatment
apparatus 10 according to the present invention is illustrated
schematically. The apparatus 10 includes a drain line 18 that is
attached to a negative pressure source 14. The drain line 18 is
preferably positioned to remove exudates from the wound 12. The
apparatus 10 also includes a supply line 20 that is attached to a
fluid source 16. The supply line 20 is preferably positioned to
supply fluid to the wound 12. A controller 22 functions to control
the therapy administered by the wound treatment apparatus 10 to the
wound 12.
[0043] As will be understood by those skilled in the art, the
controller 22 may be implemented as a control system or even as a
control circuit, such as one or more of the following: programmable
circuit, integrated circuit, memory and I/O circuits, an
application specific integrated circuit, microcontroller, complex
programmable logic device, field programmable gate arrays, other
programmable circuits, or the like.
[0044] The controller 22 can cause the wound treatment apparatus 10
to administer negative pressure therapy to the wound 12 via the
drain line 18. The controller 22 can also cause the wound treatment
apparatus 10 to administer hyperbaric fluid therapy to wound 12 via
the supply line 20. Preferably, hyperbaric fluid therapy is
administered to the wound 12 at an absolute pressure of at least
approximately 1.5 atmospheres.
[0045] In operation, negative pressure therapy and hyperbaric
oxygen therapy may each be administered intermittently. In other
words, negative pressure therapy and hyperbaric fluid therapy may
be administered in alternating treatments where the wound treatment
apparatus 10 cycles between negative pressure therapy and
hyperbaric fluid therapy or, only one type of treatment (i.e.
negative pressure therapy or hyperbaric fluid therapy) may be
administered in an intermittent manner such that the wound
treatment apparatus 10 cycles between administering treatment to
the wound 12 and not administering treatment to the wound 12.
[0046] For example, controller 22 may be configured to cause
negative pressure therapy to be administered to the wound 12 via
the drain line 18 for a first time period and hyperbaric fluid
therapy to be administered to the wound 12 via the supply line 20
for a second time period. In one presently preferred embodiment,
the first time period during which negative pressure therapy is
administered is approximately two to three times as long as the
second time period during which hyperbaric fluid therapy is
administered. The controller 22 may be further configured to cause
hyperbaric fluid therapy to be administered immediately following
the cessation of the administration of negative pressure therapy
and to cause negative pressure therapy to be administered
immediately following the cessation of the administration of
hyperbaric fluid therapy.
[0047] The administration of negative pressure therapy and
hyperbaric fluid therapy may be controlled using a variety of
methods. For example, the fluid source 16 may be configured to
supply a constant flow of fluid. The controller 22 may be
configured to cause the administration of negative pressure therapy
by activating the negative pressure source 14, which would create a
negative pressure environment at the wound 12 even though the wound
12 would continue to be exposed to fluid from the fluid source 16.
The controller 22 may be further configured to cause the
administration of hyperbaric fluid therapy by deactivating the
negative pressure source 14, thereby causing the wound 12 to be
exposed only to the fluid from the fluid source 16 and causing
pressures at the wound 12 to build to hyperbaric levels determined
by, among other factors, the flow rate of the fluid.
[0048] Another mechanism for controlling the administration of
negative pressure therapy and hyperbaric fluid therapy is to use
the controller 22 to control both the negative pressure source 14
and the fluid source 16. Thus, the controller 22 may be configured
to cause the administration of negative pressure therapy by
activating the negative pressure source 14 and either reducing the
flow from or deactivating the fluid source 16. Similarly, the
controller 22 may be further configured to cause the administration
of hyperbaric fluid therapy by deactivating the negative pressure
source 14 and increasing the flow of fluid from the fluid source
16.
[0049] Alternatively, the controller 22 may include two
controllers, one for each device. The controller that controls the
fluid source 16 may be configured to detect the state of the
negative pressure source 14 or the state of the environment
surrounding the wound 12. Upon determining an end of a negative
pressure therapy cycle, the controller controlling the fluid source
16 could cause the administration of hyperbaric fluid therapy by
activating or increasing the fluid flow from the fluid source 16.
Conversely, the controller that controls the negative pressure
source 14 could be configured to detect the state of the fluid
source 16 or the state of the environment surrounding the wound 12.
Upon determining an end of a hyperbaric fluid therapy cycle, the
controller controlling the negative pressure source 14 could cause
the administration of negative pressure therapy by activating the
negative pressure source 14.
[0050] While each of the negative pressure therapy and the
hyperbaric fluid therapy could potentially be administered to the
wound 12 for hours before alternating to the other therapy, it is
presently preferred that the controller 22 cause negative pressure
therapy to be administered to the wound 12 for relatively short
periods of time. For example, negative pressure therapy may be
administered for approximately 20 seconds to approximately 180
seconds before moving on to hyperbaric fluid therapy or to
non-therapy in the event that the apparatus is set to
intermittently apply only negative pressure therapy. Similarly, the
controller 22 may cause hyperbaric fluid therapy to be administered
to the wound 12 for approximately 10 seconds to approximately 60
seconds before moving on to negative pressure therapy or to
non-therapy in the event that the apparatus is set to
intermittently apply only hyperbaric pressure therapy.
[0051] Moreover, the negative pressure therapy and the hyperbaric
fluid therapy may be administered in a cyclical manner. For each
cycle consisting of negative pressure therapy administration and
hyperbaric fluid therapy administration, the administration of
hyperbaric fluid therapy may be limited to no more than 30 minutes.
In other words, following the administration of negative pressure
therapy for a first time period, hyperbaric fluid therapy is
administered for no more than 30 minutes, after which the negative
pressure therapy is administered again for some time period, which
may be the same as the first time period. Hyperbaric fluid therapy
would then preferably be administered again for no more than 30
minutes, after which negative pressure therapy would be
administered again.
[0052] In addition, the controller 22 may also be capable of
selectively causing the cessation of negative pressure therapy
without causing the cessation of the hyperbaric fluid therapy.
Similarly, the controller 22 is preferably configured to be capable
of selectively causing the cessation of hyperbaric fluid therapy
without causing the cessation of the negative pressure therapy.
[0053] As will be understood by those of skill in the art, the
administration of negative pressure therapy generally involves
exposing the wound 12 to pressures of less than 1 atmosphere. The
pressures employed during negative pressure therapy may include
absolute pressures ranging from approximately 0 mmHg to
approximately 300 mmHg. Preferably, the absolute pressure ranges
from approximately 60 mmHg to approximately 160 mmHg during the
administration of negative pressure therapy.
[0054] As will also be understood by those of skill in the art, the
administration of hyperbaric fluid therapy involves exposing the
wound 12 to a fluid at greater than atmospheric pressures.
Preferably, the wound 12 is subjected to an absolute pressure
ranging from approximately 1.5 atmospheres to approximately 3
atmospheres during the administration of hyperbaric fluid
therapy.
[0055] The negative pressure source 14 can be any suitable suction
device such as a vacuum, a manual, mechanical, or electrical pump,
a hospital room suction line, or any other device exhibiting vacuum
or suction capabilities. The fluid source 16 can be a suitable
fluid supply device and preferably is an oxygen source or a
humidified oxygen source, such as an oxygen concentrator, oxygen
canister, or oxygen supplied from a hospital room oxygen line. For
example, the fluid source 16 may administer oxygen or humidified
oxygen at approximately 0.1 liters per minute to approximately 3
liters per minute. Preferably, the fluid source 16 administers
oxygen or humidified oxygen at approximately 1 liter per minute to
approximately 2 liters per minute.
[0056] Also, the negative pressure source 14 and the fluid source
16 may be powered by a single power source, such as a wall plug or
a rechargeable battery, and may share a power supply, such as power
supply 23. Further, the negative pressure source 14 and the fluid
source 16 may both reside in a single portable casing that houses
the negative pressure source 14 and the fluid source 16 as one
unit.
[0057] The drain line 18 may be surgical tubing, oxygen tubing or
any other suitable type of line for removing exudate from a wound
site. The supply line 20 may be surgical tubing, oxygen tubing or
any other suitable type of line for carrying fluid, such as oxygen,
to a wound site. In addition, part of the drain line 18 and part of
the supply line 20 may be formed by a multi-lumen tube.
[0058] To perform localized administration of negative pressure
therapy and hyperbaric fluid therapy, the drain line 18 and supply
line 20 preferably engage a wound dressing. FIG. 2 is a schematic
illustration of an example wound dressing and surrounding elements
made in accordance with the current disclosure. As shown in FIG. 2,
the dressing includes packing material 42 above the wound 12 and a
drain 24 atop the packing material 42. The packing material may be,
for example, gauze, foam dressing/packing, sponges, or the like.
Preferably, the packing material is anti-microbial gauze saturated
with saline.
[0059] The drain device 24 may be included as part of the drain
line 18 or attached to the end of the drain line 18 opposite the
negative pressure source 14. Suitable drain devices include
Jackson-Pratt silicon drain, flat drain, round channel drain,
fluted drain, drain tube, Kremlin drain, or other drains capable of
removing exudates from within or on top of the wound 12. An example
of a drain 24 is illustrated in FIGS. 6-8.
[0060] Atop the drain 24 is more packing material 42. The dressing
further has a gasket 41 made from pliable adhesive material molded
around the surrounding edge of the wound 12. The drain line 18 and
the supply line 20 are atop the gasket 41. Optionally, additional
gasket 41 material is included atop the drain line 18 and supply
line 20 for engaging the drain line 18 and the supply line 20. The
gasket 41 material may be, for example, an Eakin Cohesive Seal.
[0061] Sealing material 40 surrounds the wound 12, the drain 24,
the packing material 42 and the gasket 41. The sealing material 40
can adhere to the gasket 41 and the skin surrounding the wound 12.
Preferably, the dressing is capable of maintaining adherence during
administration of hyperbaric fluid therapy at pressures of at least
3 atmospheres. The sealing material 40 preferably has adhesive
properties to withstand the pressure induced by the supply of
hyperbaric fluid from the fluid source 16 and the negative
pressures drawn by the negative pressure source 14.
[0062] It will be understood by those skilled in the art that
various types of dressings may be used. For example, the drain 24
may be positioned above the packing material 42 or below the
packing material 42, as opposed to sandwiched between packing
material 42 as shown. Also, the drain 42 and sealing material 40
may be incorporated as one device. In addition, the dressing may
also include a protective mesh separating the packing material 42
from the wound 12.
[0063] Turning next to FIG. 3, a schematic illustration of a
hospital bed embodiment of apparatus made in accordance with the
current disclosure is provided. Because of the presence of both a
negative pressure supply 14 and a fluid supply 16 in many hospital
rooms, it may be desirable to incorporate the controller 22 into a
hospital bed 25, which may include the bed frame and/or the
mattress. Thus, the controller 22 in a hospital bed 25 is
preferably used to administer negative pressure therapy and
hyperbaric pressure therapy on a wound 12 using a hospital room
suction line as the negative pressure source 14 and the hospital
room oxygen line as the fluid source 16. To control the pressures
at the wound, the apparatus further includes valves 27a and 27b
that are and located on the drain line 18 and supply line 20 and
controlled in an automated manner by the controller 22. The
apparatus may further include sensors to provide the controller 22
with information used by the controller 22 in controlling the
valves 27 and 27b.
[0064] Turning next to FIG. 4, a portable wound treatment apparatus
10 made in accordance with the current disclosure and positioned on
a wound 12 is illustrated schematically. Like FIGS. 1 and 3, FIG. 4
includes a negative pressure source 14, a fluid source 16, a
controller 22, drain line 18 and supply line 20. Attached to the
drain line 18 is a drain 24 placed in the wound 12. A dressing
including packing material 42 and a sealing material 40 is placed
over the wound 12 and adhered to the skin 11.
[0065] To make the apparatus of FIG. 3 portable, the negative
pressure source 14, the controller 22 and the fluid source 16 are
positioned in a housing 36 to house the negative pressure source 14
and the fluid source 16 as a single unit. The housing 36 may also
house the collection device 26 and a humidification device, such as
the humidification device 38 of FIG. 5. The humidification device
38 may be connected to the supply line 20 to add moisture to fluid
being supplied to the wound 12. In addition, it may be desirable to
include a power source 39, such as a rechargeable battery, within
the housing 36. The power source 39 may run both negative pressure
source 14 and the fluid source 16. The casing 36 may further
include a handle 37 used to transport the apparatus 10 and/or
suspend the apparatus 10 on a medical support such as an IV
stand.
[0066] The drain 24, in conjunction with the drain line 18 under
operation of the negative pressure source 14, may operate to
transport exudates from the wound 12 to a collection device 26
connected to the drain line 18. The exudates can be stored in the
collection device 26 until properly disposed of.
[0067] Turning next to FIG. 5, another embodiment of a wound
treatment apparatus 10 made in accordance with the current
disclosure and positioned on a wound is illustrated schematically.
Like FIGS. 1, 3 and 4, FIG. 5 includes a negative pressure source
14, a fluid source 16, a controller 22, a drain line 18 and a
supply line 20. Attached to the drain line 18 is a drain 24 placed
in the wound 12. A dressing including packing material 42 and a
sealing material 40 is placed over the wound 12 and adhered to the
skin 11. Following placement, the sealing material 40 may create a
fluidic chamber around the wound 12.
[0068] The apparatus of FIG. 5 also includes a collection device 26
connected to the drain line 18 for storing exudates from the wound
12 until properly disposed of. As shown, the drain line 18 includes
a drain line connection end 19 and the collection device 26
includes a drain line portal 15 shaped to accept the drain line
connection end 19. Preferably, the drain line portal 15 is shaped
to accept only the drain line connection end 19 so as to avoid
unintentionally connecting the supply line 20 to the drain
collection device 26. The collection device 26 may also include a
collection device sensor 28 engaging the collection device 26 and
connected to the controller 22 to indicate the level to which the
collection device 26 is filled with exudates. The controller 22 may
be configured to stop the administration of negative pressure
therapy upon receiving information from the collection device
sensor indicating that the collection device is full. In one
embodiment, the collection device sensor 28 may notify the
controller 22 and a warning can be issued to the user and/or the
apparatus 10 can be shut down.
[0069] The supply line 20 supplies fluid to the wound site.
Preferably, fluid supply 16 has a supply line portal 17 that is
shaped to accept only a supply line connection end 21 so as to
avoid unintentionally connecting the drain line 18 to the fluid
source 16. The wound treatment apparatus 10 may also include a
pressure regulator to help prevent excessive pressurization of the
wound site. The pressure regulator may be, for example, a pressure
sensor 44, which can be positioned to determine the pressure at the
wound site. For example, the pressure sensor 44 may be positioned
at the wound site or anywhere along the pathway between the fluid
source 16 and the wound 12 or anywhere along the pathway between
the negative pressure source 14 and the wound 12. The pressure
sensor 44 may be any type of device capable of providing
information to either a user or the controller 22 about the
pressure at the wound site. The pressure sensor 44 may be
operatively connected to the controller 22 and the controller 22
may be configured to adjust the negative pressure therapy or the
hyperbaric fluid therapy in response to information received from
the pressure sensor 44.
[0070] The pressure regulator may also be a mechanical pressure
regulator 30 positioned along the supply line 20 between the wound
12 and fluid supply 16. The mechanical pressure regulator 30 may be
used in conjunction with the pressure sensor 44. The mechanical
pressure regulator 30 is preferably configured to actuate when the
pressure in the supply line 20 at the pressure regulator 30 exceeds
a set threshold. The actuation of the mechanical pressure regulator
30 causes a reduction of the supply line 20 pressure. For example,
the mechanical pressure regulator 30 may include a release valve
that opens when the pressure within the supply line 20 exceeds a
certain threshold.
[0071] One embodiment of the mechanical pressure regulator 30 is
illustrated in FIG. 9. As shown, the mechanical pressure regulator
30 is a Y valve. One side of the Y valve has a wound connection
line 34 that is operatively connected to the wound 12. The opposite
side of the Y valve has two pathways. One of the pathways has a
release valve 33 for venting excess fluid. The other pathway has a
fluid source connection line 32 for connecting the mechanical
pressure regulator 30 to the fluid source 16. The mechanical
pressure regulator 30 is preferably configured to actuate when the
pressure at the mechanical pressure regulator 30 exceeds a set
threshold. Actuation of the mechanical pressure regulator 30 causes
the release valve 33 to open. The set threshold may be determined
by the desired pressure to be applied to the wound 12 during
hyperbaric fluid therapy. The actuation of the mechanical pressure
regulator 30 then causes a reduction of the supply line 20 pressure
as fluid is vented out of the system.
[0072] In addition, the mechanical pressure regulator 30 may be
configured to maintain a reduced pressure within the supply line 20
following the actuation of the mechanical pressure regulator 30.
While the venting of fluid may cause a reduction in the supply line
20 pressure, the system may equalize if the flow rate of the fluid
through the supply line 20 remains constant and the release valve
33 remains open. Thus, the mechanical pressure regulator 30 causes
the pressure in the supply line 20 to be maintained at a reduced
level.
[0073] Also as shown in FIG. 9, the Y valve 50 may connect the
drain line 18 and the supply line 20 into a single-lumen tube for
engaging the dressing. The Y valve 50 includes a drain connection
line 54 and supply connection line 56. The supply line 20 and drain
line 18 are merged together by the Y valve 50 and the merged supply
line 20 and drain line 18 are engageable with the wound 12 via the
wound connection 52.
[0074] Also as shown in FIG. 5, the wound treatment apparatus may
also include humidification device 38 operatively connected the
supply line 20. The humidification device 38 may be configured to
humidify the fluid from the fluid source 16 before the fluid is
administered to the wound 12. For example, when the fluid source 16
supplies oxygen, the humidification device 38 may function to
humidify the oxygen so that humidified oxygen is supplied to the
wound 12. In addition, the humidification device 38 may be
configured to heat the fluid in the supply line 20, thereby causing
an increase in the temperature at the wound 12. Accordingly, the
humidification device 38 may comprise a heating element 46 that is
operatively connected to the controller 22. Alternatively, a
heating element 46 may be a component of the apparatus 10 that is
separate from the humidification device 38. In operation, the
controller 22 may be configured to cause the heating element 46 to
maintain a temperature at the wound 12 above approximately 98
degrees Fahrenheit and below the combustion temperature of the
fluid administered during hyperbaric fluid therapy. Also, the
heating element 46 may be configured to control the temperature at
the wound independent of the controller 22.
[0075] The humidification device 38 may also act as a drug delivery
device. For example, the humidification device 38 may function to
introduce at least one non-oxygen drug into the supply line 20. The
non-oxygen drug may be introduced into the humidification device 38
in powder form and may be supplied by the humidification device 38
to the supply line 20 in powder form via gas. The non-oxygen drug
may also be supplied in vapor form via humidified gas.
Alternatively, a separate drug delivery device may be attached to
the supply line 20 to deliver non-oxygen drugs to the wound 12.
[0076] Also as shown in FIG. 5, the wound treatment apparatus may
further include a diffusion sensor 45 to measure diffusion of
fluid, such as oxygen, into the wound 12. The diffusion sensor 45
may be, for example, a transcutaneous oxygen sensor. The diffusion
sensor 45 is preferably operably connected to the controller 22 and
the controller 22 is preferably configured to adjust at least one
of the negative pressure therapy or the hyperbaric fluid therapy in
response to information received from the diffusion sensor 45. For
example, in response to information received from the diffusion
sensor 45 indicating that the fluid diffusion rate is below a
desired level, the controller 22 may be configured to cause an
increase in at least one of the fluid flow rate or the pressure at
the wound 12 during hyperbaric fluid therapy.
[0077] The controller 22 may also or alternatively be configured to
cause an increase in the duration of the administration of
hyperbaric fluid therapy relative to the negative pressure therapy
in response to information received from the diffusion sensor 45.
Similarly, the controller 22 may be configured to cause a decrease
in the duration of the administration of negative pressure therapy
relative to the hyperbaric fluid therapy in response to information
received from the diffusion sensor 45 indicating that the fluid
diffusion rate is below a desired level.
[0078] In another embodiment the supply line 20 has a supply line
connection end 21 while the fluid source 16 includes a supply line
portal 17. The supply line portal 17 is shaped to accept the supply
line connection end 21. The drain line 18 includes a drain line
connection end 19 while the collection device 26 includes a drain
line portal 15 shaped to accept the drain line connection end 19.
The supply line portal 17 is shaped such that it will only accept
the supply line connection end 21 while the drain line portal 15 is
shaped to only accept the drain line connection end 19. This
configuration assists in the safe connection of the negative
pressure source 14 and fluid source 16 to the proper lines 18 and
20.
[0079] The apparatus 10 can include various disposable elements and
still maintain the inventive nature disclosed herein. For example,
the drain line 18 and supply line 20 as well as the collection
device 26, or the container that collects the exudants, the sealing
material 40, packing material 42 and other elements that are in or
near the wound 12 can be made to be disposable and discarded
between uses of the remainder of the apparatus 10 to facilitate
sterilization and reduce the potential contamination of subsequent
patients by infectious diseases.
[0080] Assembly of the apparatus 10 and engagement of the apparatus
10 to a wound 12 can be accomplished as follows. The packing
material 42 can be positioned in and around the wound to take up
empty space thereby. A drain device 24 can be positioned in and
around the wound 12 and connected to the drain line 18. The drain
line connection end 19 can be attached to the negative pressure
source 14 in the drain line portal 15. The drain line 18 can
alternately go through a separate collection device 26 that will
collect the exudates from the wound 12. The supply line 20 can also
be positioned in or near the wound 12 while the supply line
connection end 21 can be inserted into the supply line portal 17 of
the fluid source 16. Alternatively the supply line 20 can be
connected to a humidification device 38 that will add moisture to
the oxygen as it flows to the wound 12.
[0081] Turning next to FIGS. 10A-F and 11, the preparation of one
embodiment of a wound dressing made in accordance with the current
disclosure is illustrated schematically and in flow chart form. As
shown in FIG. 10A and process block 1102, packing material 42 is
inserted into the wound 12. The packing material 42 preferably
comprises anti-microbial gauze saturated with saline. Prior to
inserting the packing material 42, it may be desirable to insert a
protective mesh into the wound 12. Open ends of the supply line 20
and drain line 18 are then inserted into the wound 12 atop the
packing material 42. This is illustrated in FIG. 10A and process
block 1104. As shown, the process of inserting open ends of the
supply line 20 and drain line 18 may involve inserting into the
wound 12 a drain 24 connected to the supply line 20 and drain line
18. A multi-lumen tube may form the supply line 20 and the drain
line 18. Preferably, additional packing material 42 is inserted
atop the drain 24 as shown in FIG. 10B. An example of a drain 24 is
illustrated in FIGS. 6-8.
[0082] As shown in FIG. 10C and process block 1106, a pliable
adhesive gasket 41 is molded around the perimeter of the wound 12.
Preferably, the gasket 41 separates supply line 20 and drain line
18 from the patient's skin surrounding the wound 12. The supply
line 20 and the drain line 18 are thus engaged with adhesive gasket
41. Preferably, as shown in FIG. 10C and process block 1108,
another piece of a pliable adhesive gasket 41 is then molded over
the supply line 20 and the drain line 18 to strengthen the
engagement. The pliable adhesive gasket 41 may be made from a
cohesive seal.
[0083] As shown in FIG. 10D and process block 1110, sealing
material 40 is then placed over the wound 12, the packing material
42, the supply line 20, the drain line 18 and the adhesive gasket
41 such that the sealing material 40 adheres to both the adhesive
gasket 41 and the skin surrounding the adhesive. FIGS. 10E and 10F
show the dressing during hyperbaric pressure therapy and negative
pressure therapy, respectively.
[0084] Although the invention has been shown and described with
respect to certain embodiments, it is obvious that equivalents and
modifications will occur to others skilled in the art upon the
reading and understanding of the specification. The present
invention includes all such equivalents and modifications, and is
limited only by the scope of the following claims.
* * * * *