U.S. patent application number 14/157738 was filed with the patent office on 2014-05-15 for wound exudate removal and isolation system.
This patent application is currently assigned to KCI LICENSING, INC.. The applicant listed for this patent is KCI LICENSING, INC.. Invention is credited to Devin Ginther, Jonathan Jaeb, Randall Kelch, Jennifer Novak, Tab Randolph, Teryl Blane Sanders, Tianning Xu, Xiaolu Zheng.
Application Number | 20140135719 14/157738 |
Document ID | / |
Family ID | 38123488 |
Filed Date | 2014-05-15 |
United States Patent
Application |
20140135719 |
Kind Code |
A1 |
Jaeb; Jonathan ; et
al. |
May 15, 2014 |
WOUND EXUDATE REMOVAL AND ISOLATION SYSTEM
Abstract
A wound exudate removal and isolation system includes a porous
dressing, a canister in fluid communication with the dressing, and
a first valve positioned between the dressing and the canister. The
first valve is positionable between an open position and a closed
position. A disposal line is fluidly connected to the canister and
includes a second valve that is positionable between an open
position and a closed position. A pump is fluidly connected to the
canister and is configured to draw wound exudate from the dressing
into the canister when the first valve is open and the second valve
is closed. The pump is configured to force wound exudate from the
canister into the disposal line when the first valve is closed and
the second valve is open.
Inventors: |
Jaeb; Jonathan; (Boerne,
TX) ; Randolph; Tab; (San Antonio, TX) ;
Kelch; Randall; (San Antonio, TX) ; Zheng;
Xiaolu; (San Antonio, TX) ; Ginther; Devin;
(Converse, TX) ; Xu; Tianning; (San Antonio,
TX) ; Novak; Jennifer; (San Antonio, TX) ;
Sanders; Teryl Blane; (San Antonio, TX) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
KCI LICENSING, INC. |
San Antonio |
TX |
US |
|
|
Assignee: |
KCI LICENSING, INC.
San Antonio
TX
|
Family ID: |
38123488 |
Appl. No.: |
14/157738 |
Filed: |
January 17, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13591324 |
Aug 22, 2012 |
8663199 |
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14157738 |
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11634719 |
Dec 6, 2006 |
8273074 |
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13591324 |
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60742755 |
Dec 6, 2005 |
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Current U.S.
Class: |
604/319 |
Current CPC
Class: |
A61M 1/0088 20130101;
A61M 2205/3382 20130101; A61M 2205/18 20130101; A61M 1/0005
20130101; A61M 1/0031 20130101; A61M 2205/3337 20130101; A61M
1/0052 20140204 |
Class at
Publication: |
604/319 |
International
Class: |
A61M 1/00 20060101
A61M001/00 |
Claims
1-19. (canceled)
20. A wound stasis and isolation apparatus comprising: an
open-cell, reticulated foam dressing having an average pore size
less than about 200 microns, the foam dressing being positionable
adjacent a wound; a drape to cover the foam dressing and the wound;
and a pump in fluid communication with the foam dressing to draw
wound exudate from the wound at a pressure less than about 125 mmHg
to maintain wound drainage and moisture control at the wound but
minimize tissue in-growth into the foam dressing.
21. The apparatus of claim 20, wherein the average pore size of the
foam dressing is less than or equal to about 100 microns.
22. The apparatus of claim 20, wherein the pore size of the foam
dressing minimizes tissue in-growth but allows drainage of fluids
from the wound.
23. The apparatus of claim 20, wherein the pressure is between
about 25 and 75 mmHg.
24. The apparatus of claim 20, further comprising: a
canister-positioned between the foam dressing and the pump to
collect the wound exudate, the canister having a drainage outlet;
and wherein the pump is selectively operable to force wound exudate
from the canister through the drainage outlet.
25. The apparatus of claim 24, further comprising a disposable
container positionable in fluid communication with the drainage
outlet to collect wound exudate from the canister.
26. A method of providing stasis and isolation to a wound
comprising: positioning an open-cell, reticulated foam dressing
adjacent the wound, the foam dressing having an average pore size
less than about 200 microns; positioning a drape over the foam
dressing and the wound; and applying a reduced pressure of less
than about 100 mmHg to the foam dressing.
27. The apparatus of claim 26, wherein the average pore size of the
foam dressing is less than or equal to about 100 microns.
28. The apparatus of claim 26, wherein the pore size of the foam
dressing minimizes tissue in-growth but allows drainage of fluids
from the wound.
29. The apparatus of claim 26, wherein the reduced pressure is
between about 25 and 75 mmHg.
30. A wound stasis and isolation apparatus comprising: an
open-cell, reticulated foam dressing having an average pore size
less than about 200 microns, the foam dressing being positionable
adjacent a wound; a drape to cover the foam dressing and the wound;
and a pump in fluid communication with the foam dressing to draw
wound exudate from the wound.
31. The apparatus of claim 30, wherein the average pore size of the
foam dressing is less than or equal to about 100 microns.
32. The apparatus of claim 30, wherein the pore size of the foam
dressing minimizes tissue in-growth but allows drainage of fluids
from the wound.
33. The apparatus of claim 30, wherein the pump is adapted to
minimize tissue in-growth into the foam dressing.
34. The apparatus of claim 30, wherein the pump is adapted to draw
wound exudate from the wound at a pressure less than about 125
mmHg.
35. The apparatus of claim 30, wherein the pump is adapted to draw
wound exudate from the wound at a pressure between about 25 mmHg
and about 75 mmHg.
36. The apparatus of claim 30, further comprising: a canister
positioned between the foam dressing and the pump to collect the
wound exudate, the canister having a drainage outlet; and wherein
the pump is selectively operable to force wound exudate from the
canister through the drainage outlet.
37. The apparatus of claim 36, further comprising a disposable
container positionable in fluid communication with the drainage
outlet to collect wound exudate from the canister.
38. The apparatus of claim 30, wherein the porous dressing includes
an antimicrobial agent.
39. The apparatus of claim 38, wherein the antimicrobial agent is
silver.
40. The apparatus of claim 38, wherein the antimicrobial agent is
coated onto the porous dressing.
41. The apparatus of claim 38, wherein the antimicrobial agent is
impregnated in the porous dressing.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 13/591,324, entitled "Wound Exudate Removal
and Isolation System," filed Aug. 22, 2012, which is a continuation
of U.S. patent application Ser. No. 11/634,719, entitled "Wound
Exudate Removal and Isolation System," filed Dec. 6, 2006, and
issued as U.S. Pat. No. 8,273,074 on Sep. 25, 2012, which
application claims the benefit of U.S. Provisional Application No.
60/742,755, entitled "Wound Exudate Removal and Isolation System,"
filed Dec. 6, 2005, and these applications are incorporated herein
by reference for all purposes.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention pertains to wound management. More
particularly, the present invention pertains to a wound management
system that employs reduced pressure to remove wound exudate and a
dressing that will contain and isolate the wound where the dressing
must remain on the wound for a prolonged period of time.
[0004] 2. Description of Related Art
[0005] The recent protracted combat operations of the U.S. Armed
Forces in both Afghanistan and Iraq have been remarkable in the
comparatively low level of fatalities compared to other conflict
involving U.S. Armed Forces, such as the combat operations in Viet
Nam. The reason for the comparatively low level of fatalities is
because of the dramatic improvements that have been made in
protective body armor and medical care. Significant improvements
have been made to procedures and techniques for stabilizing and
removing injured personnel from the battlefield to a facility where
medical care may be administered by personnel with proper
equipment. While there has been a dramatic decrease in the loss of
life, there also has been a corresponding increase in the number of
service members wounded. As in many combat situations, a frequent
injury to those in ground combat operations is a deep, traumatic
wound. Many military trauma wounds are inherently contaminated and
can become severely infected because of prolonged contact with the
ground on the battlefield or lengthy periods without treatment.
Field medics are taught how to irrigate and/or clean deep wounds
and then cover the wound with some type of wound dressing. The
wound dressing performs several functions. A dressing often
includes a powder, an ointment, or a salve, which may kill some of
the toxic bacteria that have entered the wound. Second, the
dressing covers the wound to help prevent entry of additional toxic
bacteria. Third, the dressing decreases the chance of cross
contaminating other wounds on a patient's body. Fourth, the
dressing absorbs fluids or exudate from the wound.
[0006] When wounds are large or deep, however, several treatment
problems arise. Because medical evacuation routes can extend
thousands of miles, it is not uncommon for wounded soldiers to
experience several days in the medical evacuation process. While
wounded personnel are in transport, it is generally not possible to
provide the type of wound treatment care available in a hospital. A
gauze dressing may not have sufficient fluid retention capacity to
adequately absorb all of the exudate from some wounds, and so may
become saturated with exudate. Saturated dressings may not be
easily exchanged for non-saturated dressings during medical
evacuation and transport by aircraft or ground/water transport
vehicles. A typical mounting arrangement in medical
transport/evacuation vehicles involves stacking patient gurneys
three or four high, often against a wall or bulkhead. Such stacking
of gurneys may limit access to exudating wounds of those patients
on the gurneys such that medical personnel often cannot readily
tend to dressings or any other equipment used to protect
wounds.
[0007] During all parts of the medical evacuation process, there is
a need to provide wound exudate management and wound isolation with
the wound contained in a closed protective environment. Further,
there is a need to remove and isolate wound exudate so that the
wound exudate, a biohazardous material, can be collected and
properly discarded. Such removal and isolation of wound exudate
will reduce cross-contamination, reduce the risk of infection, and
facilitate effective wound management during the transport of
injured soldiers. There is a need to provide a system that is
compact so that it may be easily carried and is not dependent on
any external source of energy for operation. Finally, there is a
need to provide a system that will be U.S. Military Flight
Certified, a non-capital level asset, and disposable.
BRIEF SUMMARY OF THE INVENTION
[0008] The problems presented by existing wound isolation systems
and methods are solved by the systems and methods of the present
invention. A wound exudate removal and isolation system in
accordance with one embodiment of the present invention includes a
porous dressing, a canister in fluid communication with the porous
dressing, and a first valve positioned between the porous dressing
and the canister. The first valve is positionable in an open
position to allow fluid flow and a closed position to prevent fluid
flow between the porous dressing and the canister. A disposal line
is fluidly connected to the canister, and a second valve is
operably positioned within the disposal line. The second valve is
positionable in an open position to allow fluid flow and a closed
position to prevent fluid flow through the disposal line. A pump is
positioned in fluid communication with the canister and is operable
to draw wound exudate from the porous dressing into the canister
when the first valve is open and the second valve is closed. The
pump further is operable to force wound exudate from the canister
into the disposal line when the first valve is closed and the
second valve is open.
[0009] In accordance with another embodiment of the present
invention, a wound treatment apparatus includes a means for
dressing a wound, a means for drawing exudate from the wound into a
canister, a means for isolating the wound, and a means for forcing
exudate from the canister.
[0010] In accordance with another embodiment of the present
invention, a wound stasis and isolation apparatus includes an
open-cell, reticulated foam dressing having an average pore size
less than about 200 microns. A drape is provided to cover the foam
dressing and the wound. A pump is positioned in fluid communication
with the foam dressing to draw wound exudate from the wound at a
pressure less than about 125 mmHg to maintain wound drainage and
moisture control at the wound but minimize tissue in-growth into
the foam dressing.
[0011] In accordance with another embodiment of the present
invention, a method of providing stasis and isolation to a wound is
provided. The method includes positioning an open-cell, reticulated
foam dressing adjacent the wound, the foam dressing having an
average pore size less than about 200 microns. A drape is
positioned over the foam dressing and the wound, and a reduced
pressure of less than about 100 mmHg is applied to the foam
dressing.
[0012] Other objects, features, and advantages of the present
invention will become apparent with reference to the drawings and
detailed description that follow.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 is a simple illustration of one embodiment of the
disclosed compact, self-powered, wound exudate removal and
isolation system;
[0014] FIG. 2 is a schematic diagram of the wound exudate removal
and isolation system according to FIG. 1; and
[0015] FIG. 3 is a schematic diagram of an alternative embodiment
of the wound exudate removal and isolation system in which a valve
is activated by rotating the canister.
DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT
[0016] In the following detailed description of the preferred
embodiments, reference is made to the accompanying drawings that
form a part hereof, and in which is shown by way of illustration
specific preferred embodiments in which the invention may be
practiced. These embodiments are described in sufficient detail to
enable those skilled in the art to practice the invention, and it
is understood that other embodiments may be utilized and that
logical structural, mechanical, electrical, and chemical changes
may be made without departing from the spirit or scope of the
invention. To avoid detail not necessary to enable those skilled in
the art to practice the invention, the description may omit certain
information known to those skilled in the art. The following
detailed description is, therefore, not to be taken in a limiting
sense, and the scope of the present invention is defined only by
the appended claims.
[0017] FIG. 1 is a simple illustration of one embodiment of the
disclosed compact, self-powered, wound exudate removal and
isolation system 100 of the present invention. As shown in FIG. 1,
system 100 provides for the collection and disposal of wound
exudate through a dressing, which can remain on a wound and be
effective well beyond typical dressing change intervals and
throughout the entire medical evacuation process. Accordingly, the
disclosed system 100 protects the person with a wound, those caring
for the person with the wound, and others in close proximity.
[0018] The wound exudate removal and isolation system 100 provides
a dressing and a cover 110 over the wound, which draws exudate from
the wound and moves the exudate to an exudate collection system 120
through the application of a vacuum, or reduced pressure. With
traditional reduced pressure delivery systems, the distribution of
reduced pressure at the wound site is used to encourage new tissue
growth. The wound exudate removal and isolation system 100 is
preferably used to isolate, protect, and provide stasis to the
wound site until the patient arrives at a medical facility where
the wound may be properly treated. The system 100 is therefore
configured to provide adequate wound drainage and moisture control
capabilities, while minimizing the in-growth of new tissue into the
dressing.
[0019] FIG. 2 is a schematic diagram of the wound exudate removal
and isolation system 100 according to an embodiment of the present
invention. As FIG. 2 illustrates, a porous dressing 1.0 is used to
create a protective environment over the wound. Dressing 1.0 is
preferably formed from an open-cell, reticulated foam.
Alternatively, the dressing may be formed by other materials that
are suitable for manifolding pressure across the wound. For
example, a solid sheet of material (e.g. a sheet of silicone)
having projections on one side may allow the distribution of
pressure at the wound through the flow channels formed between the
projections. Instead of or in addition to the projections, small
holes may be provided in the sheet of material to allow the
manifolding of pressure. Whatever type of dressing is used, the
dressing 1.0 should have the ability to distribute a reduced
pressure to properly draw wound exudate away from the wound. While
the system 100 is not designed to encourage granulation tissue
growth, studies have found that wounds exposed to reduced pressure
may granulate substantially in as little as 48 hours. To assist in
the eventual removal and replacement of dressings, the wound
contact surface of dressing 1.0 is designed to minimize tissue
growth thereby facilitating wound contact well beyond typical 48-72
hour dressing-change intervals.
[0020] When a foam dressing is used, the dressing 1.0 dressing
includes pores of a size that allow wound exudate to pass from a
wound into tubing 1.2., but minimize the in-growth of tissue into
the pores. The average pore size is typically between about 40 and
200 .mu.m, and preferably about 100 .mu.m. The pore sizes
associated with dressing 1.0 are typically smaller than the pore
sizes associated with dressings used to promote wound healing. The
porous dressing 1.0 may also have anti-microbial properties. In one
embodiment, the dressing may be coated or impregnated with an
antimicrobial agent such as silver.
[0021] A drape 1.1 is placed over the foam dressing 1.0 to isolate
the wound and allow for the application of a reduced pressure to
the wound 1.0 through tubing 1.2. In one embodiment, tubing 1.2 is
a plastic tubing. The dressing 1.0, the drape 1.1, and a tubing 1.2
may be contained in a small, lightweight kit, which can be easily
deployed with and stocked by Forward Military Medical Units.
[0022] The reduced pressure applied to the dressing 1.0 is strong
enough to continuously draw exudate from the wound through the
tubing 1.2. Unlike reduced pressure systems that are used to
promote the growth of granulation tissue at the wound, the primary
purpose of system 100 is to isolate and contain wounds and remove
exudate. While the reduced pressure applied to the wound through
the dressing 1.0 may be adjusted depending on the size of the wound
and the porosity of the dressing 1.0, it is preferred that the
pressure applied to the wound be less than about 125 mmHg. This
particular pressure is typically considered the minimum pressure at
which new tissue growth is accelerated in wounds; hence, it is
desired to remain below this pressure to minimize new tissue
growth. More preferably, the pressure applied to the wound through
the dressing will be between about 25 and 75 mmHg.
[0023] Again referring to FIG. 2 for illustration, a check valve 2
prevents the backflow of exudate into the wound. A push-to-open
in-line valve 3 is in fluid communication with check valve 2,
positioned downstream from the wound. Downstream from the
push-to-open in-line valve 3 is a non-removable, drainable canister
8 in fluid communication with valve 3. In one embodiment, canister
8 is drainable and constructed from a rigid material. A disposal
line 14 is fluidly connected to a drainage outlet 15 of the
canister 8. A valve 4 is positioned on the disposal line 14 in
fluid communication with the canister 8. Both valves 3, 4 are
selectively positionable in either an open position or a closed
position to allow or prevent fluid flow through the valve 3, 4.
Preferably, the placing of valve 3 in an open position results in
the valve 4 being placed in a closed position. Similarly, the
placing of valve 3 in a closed position results in the valve 4
being placed in an open position. A cam wheel 5 may be operably
connected to both valves 3, 4 to mechanically coordinate the
simultaneous positioning of the valves 3, 4.
[0024] Since the system 100 may be placed at the wound for extended
periods of time during patient transport, it may be desired to
drain the canister 8 while leaving the remainder of the system 100
in place. Valves 3, 4 are provided to allow drainage of the
canister 8 when full or when desired by the person attending to the
wound. During the application of reduced pressure to the wound,
valve 3 is open to provide fluid communication between the dressing
1.0 and the canister 8. In this configuration, valve 4 is closed to
prevent drainage of the canister 8. To drain the canister 8, valve
3 is closed and valve 4 is opened. The closing of valve 3 prevents
reduced pressure from being applied to the wound, while the opening
of valve 4 allows wound exudate in the canister 8 to drain through
the disposal line 14. Optionally, a disposable container 7 may be
connected to the disposal line 14 to collect the wound exudate
drained from the canister 8. The disposable container 7 may be a
flexible, vented disposal bag. When the disposable container 7 is
full, it may be removed and replaced with an empty container.
[0025] Reduced pressure is provided to the dressing 1.0 through the
canister by a pump 11 that is fluidly connected to the canister. In
one embodiment pump 11 is a battery-operated vacuum/pressure pump.
Alternatively, the pump 11 may be manually operated, or may be any
other pump suitable for inducing the pressures disclosed herein. As
the pump 11 applies a reduced pressure to the dressing 1.0 through
the canister 8, wound exudate is drawn from the wound and deposited
in canister 8. This operation occurs when the valve 3 is in an open
position and the valve 4 is in a closed position.
[0026] As previously described, the canister 8 may be drained by
positioning valve 3 in a closed position and valve 4 in an open
position. While the drainage operation may be facilitated by
gravitational force, the wound exudate may alternatively be forced
out of the canister 8 into the disposal line 14 by the pump 11. To
facilitate forced drainage of the canister 8, a three-way valve 9
is fluidly connected between the canister 8 and an inlet of the
pump 11. The valve 9 is selectively positionable between an active
position and a vent position. In the active position, the valve 9
allows fluid communication between the canister and the inlet of
the pump 11. In the vent position, the inlet of the pump 11 is
vented. Another three-way valve 10 is fluidly connected between the
canister 8 and an outlet of the pump 11. The valve 10 is
selectively positionable between an active position and a vent
position. In the active position, the valve 10 allows fluid
communication between the canister and the outlet of the pump 11.
In the vent position, the outlet of the pump 11 is vented. The
positioning of the valves 9, 10 is linked such that a positioning
of the valve 9 in the active position results in a positioning of
the valve 10 in the vent position. Similarly, a positioning of the
valve 9 in the vent position results in a positioning of the valve
10 in the active position.
[0027] When valve 9 is positioned in the active position and valve
10 is positioned in the vent position, the pump 11 is configured to
draw wound exudate from the dressing 1.0 into the canister 8. In
this reduced pressure configuration, valve 3 is positioned in the
open position and valve 4 is positioned in the closed position.
When valve 9 is positioned in the vent position and valve 10 is
positioned in the active position, the pump 11 is configured to
provide a positive pressure to the canister to force wound exudate
from the canister 8 into the disposal line 14. In this positive
pressure configuration, valve 3 is positioned in the closed
position and valve 4 is positioned in the open position.
[0028] A hydrophobic filter 8.1 also may be included in fluid
communication with the canister 8 to prevent fluid from entering
the tubing attached to pump 11 and valves 9 and 10.
[0029] In one embodiment, a sensor may be operably associated with
the canister 8 to detect when the canister 8 is full of wound
exudate. The sensor may be operably connected to the valves 3, 4,
9, 10 to automatically adjust the operation of the system 100 from
a reduced pressure system to a positive pressure system so that
exudate is moved from the canister 8 to the disposable container 7
when the canister 8 is full.
[0030] The system may further include a safety alarm system that
provides either an audio signal or a visual signal if the system is
not operating properly. The safety alarm system is configured to
avoid producing false alarms in response to typical patient
conditions that may occur during the medical evacuation process.
However, some events that may be detected by the safety alarm
system include, but are not limited to, leak detection events,
blockage events, full canister events, low pressure events, high
pressure events, and low battery events.
[0031] The system may also include blood detection sensors to
prevent exsanguination or the removal of copious or unhealthy
amounts of blood from a patient.
[0032] As shown in FIG. 3, the valve directing the flow of exudate
may be manually activated by rotation of the canister 8.
[0033] It should be apparent from the foregoing that an invention
having significant advantages has been provided. While the
invention is shown in only a few of its forms, it is not just
limited but is susceptible to various changes and modifications
without departing from the spirit thereof.
* * * * *