U.S. patent application number 10/267358 was filed with the patent office on 2003-05-15 for waste container for negative pressure therapy.
Invention is credited to Bitel, Alexander B., Lockwood, Jeffrey S., Petrosenko, Robert, Risk, James R. JR..
Application Number | 20030093041 10/267358 |
Document ID | / |
Family ID | 23281404 |
Filed Date | 2003-05-15 |
United States Patent
Application |
20030093041 |
Kind Code |
A1 |
Risk, James R. JR. ; et
al. |
May 15, 2003 |
Waste container for negative pressure therapy
Abstract
A system for treating a patient with a wound comprises a
bandage, a receptacle, and a vacuum source. The bandage comprises a
cover to seal about the wound and to define a space above the wound
in which a vacuum is to be formed. The bandage further comprises a
port providing communication with the space. The receptacle is
connected to the port to receive exudate from the wound and is
provided to be placed below the wound. The vacuum source is spaced
apart from the receptacle, is connected to the receptacle, and is
effective to provide a vacuum in the receptacle and in the
space.
Inventors: |
Risk, James R. JR.;
(Fountaintown, IN) ; Petrosenko, Robert;
(Batesville, IN) ; Bitel, Alexander B.;
(Cincinnati, OH) ; Lockwood, Jeffrey S.;
(Batesville, IN) |
Correspondence
Address: |
BARNES & THORNBURG
11 SOUTH MERIDIAN
INDIANAPOLIS
IN
46204
|
Family ID: |
23281404 |
Appl. No.: |
10/267358 |
Filed: |
October 9, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60328542 |
Oct 11, 2001 |
|
|
|
Current U.S.
Class: |
604/308 ;
604/313 |
Current CPC
Class: |
A61M 1/90 20210501; A61M
27/00 20130101; A61M 1/784 20210501 |
Class at
Publication: |
604/308 ;
604/313 |
International
Class: |
A61F 013/00 |
Claims
1. A system for treating a patient with a wound, the system
comprising: (a) a bandage comprising a cover to seal about the
wound and define a space above the wound in which a vacuum is to be
formed, and a port providing communication with the space, (b) a
receptacle to be placed below the wound and connected to the port
to receive exudate from the wound, and (c) a vacuum source spaced
apart from the receptacle and connected to the receptacle, the
vacuum source being effective to provide a vacuum in the receptacle
and in the space.
2. The system of claim 1, further including a first tube coupled to
the port of the bandage and the receptacle and a second tube
coupled to the vacuum source and the receptacle.
3. The system of claim 2, wherein the receptacle further includes
an inlet port coupled to the first tube and an outlet port coupled
to the second tube.
4. The system of claim 3, wherein the receptacle further includes
an anti-microbial filter adjacent the outlet port.
5. The system of claim 4, wherein the filter is hydrophobic.
6. The system of claim 1, wherein the receptacle includes an air
vent to allow an inner area of the receptacle to communicate with
the surrounding atmosphere.
7. The system of claim 1, wherein the receptacle includes an upper
portion and a lower portion coupled to the upper portion, and
wherein the upper portion of the receptacle is formed from a rigid
material.
8. The system of claim 7, wherein the upper portion of the
receptacle includes an inlet port coupled to the bandage and an
outlet port coupled to the vacuum source.
9. The system of claim 7, wherein the lower portion of the
receptacle is formed from a flexible material.
10. The system of claim 1, wherein the vacuum bandage, receptacle,
and vacuum source are configured to operate in series with each
other.
11. The system of claim 1, further including a mounting portion
coupled to the receptacle.
12. The system of claim 1, comprising a control dominating the
vacuum source, the control being configured to establish the amount
of vacuum applied to the space.
13. The system of claim 12, wherein the control is configured to
establish the time when vacuum is applied to the space.
14. The system of claim 1, comprising means for attaching the
receptacle to a support below the wound.
15. The system of claim 1, comprising means for supporting the
vacuum source away from the receptacle.
16. A system for creating a vacuum above a wound and drawing
exudate away from the wound, the system comprising: (a) a vacuum
bandage to place over and seal about the wound on a patient to
provide a vacuum space above the wound and a port communicating
with the space, (b) a receptacle configured to be placed below the
wound, the receptacle being in communication through the port with
the vacuum space, and (c) a vacuum source positioned away from the
receptacle and connected to the receptacle to provide a vacuum in
the receptacle and in the vacuum space, thereby subjecting a
surface of the wound to vacuum therapy.
17. The system of claim 16, wherein the vacuum source comprises a
vacuum pump and associated controls, the pump being connected to
the receptacle.
18. The system of claim 17, wherein the vacuum source is positioned
above the receptacle.
19. The system of claim 16, wherein the vacuum source is positioned
above the receptacle.
20. The system of claim 16, wherein the vacuum source comprises a
flow sensor to be connected to a vacuum line, the flow sensor being
configured to determine the level of vacuum present in the
receptacle.
21. The system of claim 16, comprising means for supporting the
receptacle below the wound.
22. The system of claim 16, comprising means for supporting the
vacuum source above the receptacle.
23. A method for treating a wound on a patient, the method
comprising the steps of: (a) sealing a bandage having a port about
the wound to define a space above the wound and in communication
with the port in which a vacuum can be formed, (b) placing a
receptacle below the wound, (c) placing a vacuum source spaced away
from the receptacle, (d) connecting the receptacle to the port of
the bandage, (e) connecting the vacuum source to the receptacle,
and (f) operating the vacuum source to evacuate the receptacle and
provide a vacuum in the space above the wound.
24. The method of claim 23, comprising the step of controlling the
level of vacuum applied to the space and the time of application of
the vacuum.
Description
[0001] This application claims priority under 35 U.S.C. 119(e) to
U.S. Provisional Application Serial No. 60/328,542, filed Oct. 11,
2002, which is expressly incorporated by reference herein.
FIELD OF THE INVENTION
[0002] The present invention relates to a wound treatment system
and specifically to a vacuum therapy wound treatment system for
surface wounds. More specifically, the present invention relates to
the drainage and collection of exudate from the wound surface
through vacuum therapy.
BACKGROUND FO THE DISCLOSURE
[0003] Medical professionals, such as nurses and doctors, routinely
treat patients having surface wounds of varying size, shape, and
severity. It is known that controlling the topical atmosphere
adjacent a wound can enhance the healing process. For example, by
applying medicinal agents or even water over a wound, dirt and
bacteria are either killed or washed away, thereby promoting
healing. In addition, applying a negative pressure or vacuum to a
wound draws out exudate, which might contain dirt and bacteria,
from the wound to further promote healing.
[0004] A vacuum bandage is a bandage having a cover for sealing
about the outer perimeter of the wound and under which a vacuum is
established to act on the wound surface. This vacuum applied to the
wound surface accelerates healing of chronic wounds. Typically,
suction tubes are provided for drawing exudate away from the wound.
If the cover is a flexible cover, which is typically more
comfortable for the patient, a porous packing may be provided under
the cover to provide the space in which the vacuum is formed. The
following U.S. Patents establish the nature of vacuum treatment
bandages and devices: U.S. Pat. Nos. 6,095,992, 6,080,189,
6,071,304, 5,645,081, 5,636,643, 5,358,494, 5,298,015, 4,969,880,
4,655,754, 4,569,674, 4,382,441, and 4,112,947. All of such
references are incorporated herein by reference for purposes of
disclosing the nature of such vacuum treatment of wounds.
[0005] As shown, for example, in U.S. Pat. No. 5,645,081
(hereinafter the '081 patent), a method of treating tissue damage
is provided by applying negative pressure to a wound. The negative
pressure is provided in sufficient duration and magnitude to
promote tissue migration in order to facilitate the closure of the
wound. FIG. 1 of the '081 patent discloses an open cell polyester
foam section covering the wound, a flexible hollow tube inserted
into the foam section at one end and attached to a vacuum pump at
another end, an adhesive sheet overlying the foam section, and
tubing to adhere to the skin surrounding the wound in order to form
a seal that allows the creation of a vacuum when the suction pump
is operating. The '081 patent further teaches use of negative
pressure between about 0.1 and 0.99 atmospheres, and that the
pressure can be substantially continuous, wherein the pressure is
relieved only to change the dressing on the wound. Alternatively,
the '081 patent teaches use of a cyclic application of pressure in
alternating periods of application and non-application. In a
preferred embodiment, pressure is applied in 5 minute periods of
application and non-application.
[0006] Various other prior art references teach the value of the
vacuum bandage or the provision of vacuum to the surface of a
chronic wound. Several Russian language articles exist that
establish the efficacy of vacuum therapy. Examples of such prior
art articles, each of which discusses the use of application of
vacuum to a wound to promote healing, are as follows: "Vacuum
therapy in the treatment of acute suppurative diseases of soft
tissues and suppurative wound", Davydov, et al. Vestn. Khir.,
September 1988 (the September 1988 article); "Pathenogenic
mechanism of the effect of vacuum therapy on the course of the
wound process", Davydov, et al. Khirurigiia, June 1990 (the June
1990 article); and "Vacuum therapy in the treatment of suppurative
lactation mastitis", Davydov, et al., Vestn. Khir., November 1986
(the November 1986 article).
[0007] The Russian articles distinguish wound drainage from the use
of vacuum therapy for healing. The Russian authors report that
vacuum therapy resulted in faster cleansing of the wound and more
rapid detoxification than with the traditional incision-drainage
method. The November 1986 article describes the vacuum therapy
techniques as a reduction of 0.8-1.0 atmosphere for 20 minutes at
the time of surgery, and subsequent 1.5 to 3 hour treatments at a
reduced pressure of 0.1 to 0.15 from atmosphere, twice daily. These
Russian articles teach the use of negative pressure to effect
healing. The articles describe using several sessions per day, each
lasting up to one hour, with a vacuum of 76-114 mmHg.
[0008] The Russian articles teach using this vacuum method to
decrease the number of microbes in the wound. The June 1990 article
teaches that vacuum therapy provides a significant antibacterial
effect. The June 1990 article describes the stepped up inflow of
blood to the zone around the wound, which leads to an increase in
the number of leukocytes reaching the focus of inflammation.
Subsequent articles and patents further develop the benefits
obtained with vacuum therapy. The prior art, therefore, teaches the
benefit and value of a vacuum bandage.
SUMMARY OF THE DISCLOSURE
[0009] Accordingly, a vacuum therapy system for treating a patient
with a wound is provided. The system includes a vacuum bandage
comprising a cover to seal about the wound. The cover also defines
a space above the wound in which a vacuum is to be formed. The
bandage further comprises a port which provides communication with
the space. The system further includes a receptacle to be placed
below the wound. The receptacle is connected to the port to receive
exudate from the wound. Finally, the system includes a vacuum
source spaced apart from the receptacle and connected to the
receptacle. The vacuum source is effective to provide a vacuum in
the receptacle and in the space above the wound.
[0010] Illustratively, the system may comprise one or more of the
following features alone or in combination with each other: a first
tube coupled to the port of the bandage and the receptacle, a
second tube coupled to the vacuum source and the receptacle, a
means for attaching the receptacle to a support below the wound, a
means for supporting the vacuum source away from the receptacle,
and/or a control dominating the vacuum source to establish the
amount of vacuum applied to the space and the time when the vacuum
is applied to the space.
[0011] Further illustratively, the receptacle of the system may
comprise one or more of the following features alone or in
combination with each other: an antimicrobial filter, an air vent
to allow an inner area of the receptacle to communicate with the
surrounding atmosphere, a mounting portion, and an upper portion
and a lower portion coupled to the upper portion. The
anti-microbial filter may be hydrophobic, and the upper portion of
the receptacle may be made of a rigid material while the lower
portion pf the receptacle may be made of a flexible material.
[0012] The vacuum source of the system may comprise a vacuum pump
and associated controls and/or a flow sensor to be connected to a
vacuum line. Illustratively, the flow sensor may be configured to
determine the level of vacuum present in the receptacle.
[0013] A method for treating a wound on a patient is also provided
including the steps of sealing a bandage having a port about the
wound to define a space above the wound in which a vacuum can be
formed, placing a receptacle below the wound, and placing a vacuum
source spaced away from the receptacle. The method further includes
the steps of connecting the receptacle to the port of the bandage,
connecting the vacuum source to the receptacle, and operating the
vacuum source to evacuate the receptacle and provide a vacuum in
the space above the wound. The method further includes the step of
controlling the level of vacuum applied to the space and the time
of application of the vacuum.
[0014] Additional features and advantages of the apparatus will
become apparent to those skilled in the art upon consideration of
the following detailed descriptions exemplifying the best mode of
carrying out the apparatus as presently perceived.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The detailed description particularly refers to the
accompanying figures in which:
[0016] FIGS. 1-4 are perspective views of a vacuum therapy system
and a patient undergoing vacuum therapy treatment showing a vacuum
bandage of the system coupled to the patient, a waste drainage
container or receptacle coupled to the vacuum bandage by a first
tube and a housing including a vacuum source coupled to the
receptacle by a second tube, and also showing the receptacle
positioned below the wound and spaced apart from housing;
[0017] FIG. 1 is a perspective view showing the housing mounted on
a mobile IV pole;
[0018] FIG. 2 is a perspective view similar to FIG. 1 showing the
housing positioned on a bedside cabinet;
[0019] FIG. 3 is a perspective view similar to FIGS. 1 and 2
showing the housing mounted to an on-bed IV pole;
[0020] FIG. 4 is a perspective view similar to FIGS. 1-3 showing
the housing mounted on a footboard of the patient's hospital
bed;
[0021] FIG. 5 is a sectional view of an illustrative receptacle
showing the first tube coupled to an inlet port of the receptacle
and showing the second tube coupled to an outlet port of the
receptacle and also showing a hydrophobic filter positioned at the
outlet port of the receptacle;
[0022] FIG. 6 is a perspective view of another illustrative waste
receptacle of the present invention showing a mounting portion of
the receptacle for mounting the receptacle to a bed frame of the
hospital bed, as shown in FIGS. 1-4; and
[0023] FIG. 7 is a perspective view of yet another illustrative
waste receptacle of the present invention showing an alternative
mounting portion of the receptacle for mounting the receptacle to
the bed frame of the hospital bed.
DETAILED DESCRIPTION OF THE DRAWINGS
[0024] A vacuum therapy system 10 is provided for use with a wound
on a patient 14, as shown in FIGS. 1-4. System 10 comprises a
vacuum bandage 16, a waste container or receptacle 18 coupled to
the bandage 16, and a housing 20 coupled to the receptacle 18.
Housing 20 includes a vacuum source 21 (shown in FIG. 5) for
applying negative pressure to the wound to draw exudate from the
wound in order to facilitate healing. Receptacle 18 is provided to
collect the exudate drawn from the wound and is placed below the
wound to facilitate the drainage of exudate from the wound by
gravity as well as suction. Housing 20, which includes the vacuum
source 21, is spaced apart from receptacle 18 in order to allow a
caregiver to place the housing 20 in any convenient location while
still benefiting from the gravitational effects gained by
maintaining the receptacle 18 at a level below the wound.
[0025] Illustrative vacuum bandages and vacuum and irrigation
systems are disclosed in U.S. patent application Ser. No.
09/725,352 to Lockwood, et al. titled "VACUUM THERAPY AND CLEANSING
DRESSING FOR WOUNDS", U.S. patent application Ser. No. 09/725,666
to Risk et al. titled "WOUND TREATMENT APPARATUS", and U.S. patent
application Ser. No. 09/369,113 to Henley et al. titled "WOUND
TREATMENT APPARATUS". Each of these applications are assigned to
the same assignee as the present application and are specifically
incorporated herein by reference.
[0026] Vacuum bandage 16 includes a cover 22 to seal about the
wound. The bandage 16 operates to define a space above the wound to
which negative pressure can be applied to form a vacuum. The
bandage 16 further includes a port 23 in communication with the
space above the wound. The port 23 is coupled to receptacle 18 by a
first tube 24 of the system 10. First tube 24 includes a first end
26 coupled to the port 23 and a second end 28 coupled to the
receptacle 18. System 10 further includes a second tube 30 coupled
at a first end 32 to the receptacle 18 and coupled at a second end
34 to the vacuum source 21 which may be contained within housing
20.
[0027] Illustrative receptacle 18 of the vacuum therapy system 10
includes a body 40 which forms an interior cavity 42 for collecting
exudate 62 (shown in FIG. 5) and fluid drawn from the wound
therein. Although receptacle 18 is illustratively shown in FIG. 5,
the height, width, and shape of receptacle 18 may take various
forms. Body 40 includes an upper portion 44 and a lower portion 46
coupled to the upper portion 44. Upper portion 44 defines an inlet
port 48 coupled to the first tube 24, and an outlet port 50 coupled
to the second tube 26. In illustrative embodiments, upper portion
44 of the receptacle 18 is formed from a rigid material and the
lower portion 46 of the receptacle 18 is also formed from a rigid
material and is integral with the upper portion 44, as shown, for
example, in FIGS. 5-7. However, it is within the scope of this
disclosure to include a receptacle having a lower portion 46 made
from a flexible material as well. For example, lower portion 46 may
be a flexible bag removably coupled to the upper portion 44 of
receptacle 18.
[0028] As shown in FIG. 5, receptacle 18 further includes a
hydrophobic filter 60 in communication with second tube 30 and thus
the vacuum source 21. Illustratively, filter 60 is a 0.2-micron
hydrophobic anti-microbial filter. Upper portion 44 of receptacle
18 further defines an air vent 64 to provide communication between
interior cavity 42 of receptacle 18 and the outside atmosphere.
Preferably, as shown in FIG. 5, hydrophobic filter 60 is positioned
over air vent 64 to prevent bacteria, etc. in the surrounding
atmosphere from entering receptacle 18.
[0029] As mentioned above, first end 32 of second tube 30 is
coupled to outlet port 50 of receptacle 18 and second end 34 of
second tube 30 is coupled to vacuum source 21. Vacuum source 21 may
be contained within housing 20 or may be external to the housing
20. For example, most medical facilities have vacuum ports near
where patients are treated, such as in-wall vacuum ports, for
example. Each port is served by a system vacuum pump to provide
negative pressure. Vacuum source 21 is also defined to include any
type of mechanism for providing negative pressure such as an
electrically operated or manual pump, for example. Housing 20 is
configured to be a portable unit allowing a caregiver to move
housing 20 to wherever the patient is located within close
proximity to the wound or wounds. For example, as shown in FIGS.
1-4, the housing 20 is shown to be coupled to a mobile IV pole 70,
positioned on a bedside cabinet 72, coupled to an on-bed IV pole
74, and coupled to a footboard 76 of the hospital bed 78. Each of
the mobile IV pole 70, cabinet 72, in-bed IV pole 74, and footboard
76 illustrate an example of a means for supporting the housing 20
and vacuum source 21 away from receptacle 18. The housing 20 and
its vacuum source 21 may be placed above, at generally the same
level, or below the receptacle 18. Preferably, the receptacle 18
will be placed below the wound.
[0030] In addition to the vacuum source 21, it is also within the
scope of the disclosure for housing 20 to include a controller (not
shown) for controlling the amount and rate of negative pressure to
be applied to the wound, for example. Housing 20 may also include
an irrigation system and such other devices and components as
disclosed in U.S. patent application Ser. No. 09/725,666,
referenced above and incorporated herein.
[0031] As described above, the components of system 10 (vacuum
bandage 16, first tube 24, receptacle 18, second tube 30, and
vacuum source 21) are coupled to each other in series. The port of
vacuum bandage 16 is coupled to the receptacle 18 by first tube 24.
First tube 24 is coupled to inlet port 48 of receptacle 18 and
receptacle 18 is coupled to the housing 20, or more specifically,
to the vacuum source 21, by second tube 30. First end 32 of second
tube 30 is coupled to outlet port 50 of receptacle 18 and second
end 34 of second tube 30 is coupled to vacuum source 21. By this
series configuration, the vacuum source 21 is thus in fluid
communication with the receptacle 18 through the second tube 3, and
the space above the wound created by vacuum bandage 16 is in fluid
communication with receptacle 18 through first tube 24. Therefore,
the vacuum source 21 operates to create negative pressure, or a
vacuum, in the space above the wound, in the first tube 24, in
receptacle 18, and in second tube 30.
[0032] Illustratively, a flow sensor (not shown) may be coupled to
second tube 30 between receptacle 18 and vacuum source 21 for
monitoring the fluid flow from receptacle 18 to vacuum source 21.
The flow sensor may then provide feedback to the controller, for
example, located within housing 20. If, for example, the flow
sensor detects no fluid flow, the feedback sent to the controller
would signal the vacuum source 21 to turn off or cease running.
[0033] In operation, it is possible that at a period of time after
negative pressure is created above the wound, system 10 may become
relatively static due to a lack of fluid flow through system 10. As
mentioned above, this lack of fluid flow could cause the vacuum
source 21 to be turned off. However, it may still be beneficial to
provide a vacuum above the wound in order to draw blood up to the
surface of the wound. Air vent 64 is provided in receptacle 18 in
order to maintain a small amount of fluid flow to prevent the flow
sensor from detecting a static system. Once system 10 has become
relatively static and there is little to no fluid flow from bandage
16 through first tube 24 and to receptacle 18, vacuum source 21 is
still able to pull air through air vent 64 thus allowing the flow
sensor to detect a fluid flow in order to keep the vacuum source 21
running. Once the level of exudate 62 collected within receptacle
18 reaches air vent 64 and/or outlet port 50, hydrophobic filter 60
will prevent liquid to pass therethrough and the flow sensor will
sense that the flow has become static. The flow sensor will send a
signal to the controller which will, in turn, tell the vacuum
source 21 to turn off.
[0034] In use, receptacle 18 is positioned below the vacuum bandage
16 and the patient's wound to which the vacuum bandage 16 is
attached. As shown in FIGS. 1-4, placing receptacle 18 below the
wound facilitates the drainage of exudate from the wound through
gravity. Therefore, exudate is drawn from the wound through the use
of a negative pressure supplied by vacuum source 21 and through the
use of gravity. Receptacle 18 is also spaced apart from vacuum
source 21 and/or the housing 20, as shown in FIGS. 1-4. As stated
above, vacuum source 21 is often provided within housing 20.
Therefore, spacing receptacle 18 apart from the vacuum source 21
allows the housing 20 to be placed at any desired location or level
while still maintaining use of gravity for the collection of
exudate within receptacle 18.
[0035] In illustrative embodiments, receptacle 18 includes a
mounting portion 80 coupled to the body 40, as shown in FIGS. 6 and
7. Mounting portion 80 is provided to allow a caregiver to mount
the receptacle 18 to hospital bed 78 below the patient 14 and thus
below the wound in order to facilitate the drainage of the exudate
from the wound by gravity. Hospital beds 78 often to include a hook
(not shown) or a type of mount or support coupled to a bed frame 82
of the bed 78. Urine bags, for example, are often hung by the
caregiver from these hooks to facilitate drainage through the use
of gravity alone.
[0036] Mounting portion 80 of receptacle 18, as shown in FIG. 6, is
in the shape of a handle to define an aperture 84 for receiving the
hook or mount coupled to bed frame 82. Mounting portion 80 is
coupled to a top wall 86 of body 40 to cooperate with body 40 and
form aperture 84. Mounting portion 80 includes a first generally
vertical member 88 coupled to top wall 86, a second generally
vertical member 90 coupled to top wall 86, and a generally
horizontal member 92 spaced-apart from top wall 86 and coupled to
and positioned to extend between each of the first and second
generally vertical members 88, 90.
[0037] Another illustrative mounting portion 180 is shown in FIG.
7. Alternate mounting portion 180 is hook-shaped and includes a
single curved member coupled to the top wall 86 of the receptacle
18 to define a hook-receiving space 182 for receiving a hook or
mount of the bed frame 82. Although mounting portion 80 and
alternate mounting portion 180 are disclosed and described herein,
it is within the scope of this disclosure to include a receptacle
having a mounting portion adapted to cooperate with the bed frame
of the hospital bed in order to support the receptacle below the
wound of the patient being treated.
[0038] Although the invention has been described in detail with
reference to certain preferred embodiments, variations and
modifications exist within the scope and spirit of the
invention.
* * * * *