U.S. patent application number 17/165263 was filed with the patent office on 2021-06-24 for systems and methods for managing reduced pressure at a plurality of wound sites.
The applicant listed for this patent is KCI Licensing, Inc.. Invention is credited to Colin John HALL, Christopher Brian LOCKE.
Application Number | 20210187172 17/165263 |
Document ID | / |
Family ID | 1000005432931 |
Filed Date | 2021-06-24 |
United States Patent
Application |
20210187172 |
Kind Code |
A1 |
HALL; Colin John ; et
al. |
June 24, 2021 |
SYSTEMS AND METHODS FOR MANAGING REDUCED PRESSURE AT A PLURALITY OF
WOUND SITES
Abstract
Systems and methods are presented for providing reduced pressure
to and monitoring pressure at a plurality of tissue sites using a
plurality of pressure management devices. The pressure management
devices are associated with a plurality of sensing conduits that
fluidly couple the pressure management devices and the plurality of
tissue sites. Other systems, methods, and devices are
disclosed.
Inventors: |
HALL; Colin John; (Poole,
GB) ; LOCKE; Christopher Brian; (Bournemouth,
GB) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
KCI Licensing, Inc. |
San Antonio |
TX |
US |
|
|
Family ID: |
1000005432931 |
Appl. No.: |
17/165263 |
Filed: |
February 2, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15156997 |
May 17, 2016 |
10940243 |
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17165263 |
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13292926 |
Nov 9, 2011 |
9364591 |
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15156997 |
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61414718 |
Nov 17, 2010 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 1/90 20210501; A61M
2207/00 20130101; A61M 2205/84 20130101; A61M 1/732 20210501; A61M
1/74 20210501; A61M 2205/3344 20130101; A61M 2205/18 20130101 |
International
Class: |
A61M 1/00 20060101
A61M001/00 |
Claims
1.-35. (canceled)
36. A system to manage reduced pressure for reduced pressure
treatment, the system comprising: a first pressure management
device coupled to: a reduced-pressure source and a first
reduced-pressure dressing, and a first sensing conduit in fluid
communication with the first reduced-pressure dressing; the first
pressure management device comprising: a first force transducer
associated with the first sensing conduit and electrically coupled
to a first controller to determine when a reduced-pressure
threshold exists at a tissue site via the first sensing conduit,
and a first indicator configured to indicate when insufficient
pressure exists in the first sensing conduit; a second pressure
management device coupled to: the reduced-pressure source and a
second reduced-pressure dressing, and a second sensing conduit in
fluid communication with the second reduced-pressure dressing; and
the second pressure management device comprising: a second force
transducer associated with the second sensing conduit and
electrically coupled to a second controller to determine when a
reduced-pressure threshold exists at a tissue site via the second
sensing conduit, and a second indicator configured to indicate when
insufficient pressure exists in the second sensing conduit.
37. The system of claim 36, wherein the first pressure management
device further comprises a first activation sensor configured to
operate the first controller when detecting a reduced pressure, and
wherein the second pressure management device further comprises a
second activation sensor configured to operate the second
controller when detecting a reduced pressure.
38. The system of claim 37, wherein the first activation sensor is
fluidly coupled to a first reduced-pressure delivery conduit
associated with the first pressure management device and
electrically coupled to the first controller, and wherein the
second activation sensor is fluidly coupled to a second
reduced-pressure delivery conduit associated with the second
pressure management device and electrically coupled to the second
controller.
39. The system of claim 36, wherein each of the first indicator and
the second indicator are selected from a group of an audible
indicator and a visual indicator.
40. The system of claim 36, wherein each of the first pressure
management device and the second pressure management device further
comprises a muting switch.
41. The system of claim 36, wherein each of the first pressure
management device and the second pressure management device are
coupled to form an integral module.
42. The system of claim 36, wherein each of the first
reduced-pressure dressing and the second reduced-pressure dressing
comprises: a manifold for placing proximate to a tissue site, a
sealing member for covering the manifold and tissue site to create
a sealed space, and a reduced-pressure interface for providing
reduced pressure to the sealed space.
43. The system of claim 36, wherein at least the first pressure
management device comprises: a first coupling member coupled to a
first portion of a housing of the first pressure management device,
a second coupling member coupled to a second portion of the housing
of the first pressure management device, and wherein the first
coupling member is sized and configured to couple with another
coupling member on another pressure management device to couple the
first pressure management device into direct contact with another
pressure management device.
44. A system for managing reduced pressure at a plurality of tissue
sites undergoing reduced pressure treatment on a patient, the
system comprising: a reduced-pressure source for providing reduced
pressure; a first plurality of reduced-pressure delivery conduits
fluidly coupled to the reduced-pressure source, each
reduced-pressure delivery conduit of the first plurality of
reduced-pressure delivery conduits having a first end and a second
end, and wherein the second end has a first pressure-management
connector; a second plurality of reduced-pressure delivery conduits
each having a first end and a second end, and wherein the first end
has a second pressure-management connector; a plurality of
reduced-pressure dressings coupled to the second plurality of
reduced-pressure delivery conduits in a one-to-one fashion; wherein
the first pressure-management connectors of the first plurality of
reduced-pressure delivery conduits is coupled to the second
pressure-management connectors of the second plurality of
reduced-pressure delivery conduits in a one-to-one fashion, and
wherein the first pressure-management connectors and second
pressure-management connectors couple to form a plurality of
pressure-management devices; wherein each reduced-pressure dressing
has one of the second reduced-pressure delivery conduits associated
with the reduced-pressure dressing; and wherein each pressure
management device of the plurality of pressure management devices
comprises: a controller, a power unit electrically coupled to the
controller for providing power to the controller, a force
transducer associated with a sensing conduit of the first plurality
of reduced-pressure delivery conduits and electrically coupled to
the controller for determining if a reduced-pressure threshold
exists at a tissue site associated with the sensing conduit, and an
indicator coupled to the controller for indicating when
insufficient pressure exists at an associated sensing conduit.
45. The system of claim 44, wherein for each pressure management
device, the indicator is coupled to a first pressure-management
connector of the first pressure-management connectors.
46. The system of claim 44, wherein for each pressure management
device, the indicator is coupled to a first pressure-management
connector of the first pressure-management connectors and the
controller, the power unit, and the force transducer are coupled to
the second pressure-management connector of the second
pressure-management connectors.
47. A method of manufacturing a system for managing reduced
pressure at plurality of tissue sites undergoing reduced pressure
treatment on a patient, the method comprising: providing a
reduced-pressure source for providing reduced pressure; providing a
plurality of reduced-pressure delivery conduits; fluidly coupling
the plurality of reduced-pressure delivery conduits to the
reduced-pressure source; providing a plurality of reduced-pressure
dressings; providing plurality of pressure management devices;
providing a plurality of sensing conduits; fluidly coupling the
plurality of pressure management devices in a one-to-one fashion to
the plurality of sensing conduits; wherein each reduced-pressure
dressing has a sensing conduit of the plurality of sensing conduits
and a reduced-pressure delivery conduit of the plurality of
reduced-pressure delivery conduits associated with the
reduced-pressure dressing; and wherein each pressure management
device of the plurality of pressure management devices comprises: a
controller, a power unit electrically coupled to the controller for
providing power to the controller, a force transducer associated
with a sensing conduit of the plurality of sensing conduits and
electrically coupled to the controller for determining if a
reduced-pressure threshold exists at a tissue site associated with
the sensing conduit, and an indicator coupled to the controller for
indicating when insufficient pressure exists in an associated
sensing conduit.
Description
RELATED APPLICATION
[0001] This application is a Divisional of U.S. patent application
Ser. No. 15/156,997, filed May 17, 2016, which is a Divisional of
U.S. patent application Ser. No. 13/292,926, filed Nov. 9, 2011,
now U.S. Pat. No. 9,364,591, which claims the benefit, under 35 USC
.sctn. 119(e), of the filing of U.S. Provisional Patent Application
Ser. No. 61/414,718, entitled "Systems and Methods for Managing
Reduced Pressure at a Plurality of Wound Sites," filed Nov. 17,
2010, which are incorporated herein by reference for all
purposes.
FIELD
[0002] The present disclosure relates generally to medical
treatment systems and, more particularly, but not by way of
limitation, to systems, devices, and methods for managing reduced
pressure at a plurality of wound sites.
BACKGROUND
[0003] Clinical studies and practice have shown that providing a
reduced pressure in proximity to a tissue site augments and
accelerates the growth of new tissue at the tissue site. The
applications of this phenomenon are numerous, but application of
reduced pressure has been particularly successful in treating
wounds. This treatment (frequently referred to in the medical
community as "negative pressure wound therapy," "reduced pressure
therapy," or "vacuum therapy") provides a number of benefits, which
may include faster healing and increased formulation of granulation
tissue. Typically, when applied to open wounds, reduced pressure is
applied to tissue through a porous pad or other manifold device.
The porous pad contains cells or pores that are capable of
distributing reduced pressure to the tissue and channeling fluids
that are drawn from the tissue. At times, a patient may have a
large wound requiring treatment at numerous sites or has a
plurality of tissue sites requiring treatment.
SUMMARY
[0004] According to some illustrative embodiments, systems and
methods are presented for providing reduced pressure to and
monitoring pressure at a plurality of tissue sites using a
plurality of pressure management devices. The pressure management
devices are associated with a plurality of sensing conduits that
fluidly couple the pressure management devices and the plurality of
tissue sites.
[0005] According to an illustrative embodiment, a system for
managing reduced pressure at multiple tissue sites undergoing
reduced pressure treatment on a patient includes a reduced-pressure
source for providing reduced pressure, a plurality of
reduced-pressure delivery conduits fluidly coupled to the
reduced-pressure source, a plurality of reduced-pressure dressings
fluidly coupled to the plurality of reduced-pressure delivery
conduits in a one-to-one fashion, a plurality of pressure
management devices, and a plurality of a sensing conduits fluidly
coupled to the plurality of pressure management devices in a
one-to-one fashion. Each reduced-pressure dressing has a sensing
conduit of the plurality of sensing conduits and a reduced-pressure
delivery conduit of the plurality of reduced-pressure delivery
conduits associated with the reduced-pressure dressing. Each
pressure management device of the plurality of pressure management
devices may include a controller, a power unit electrically coupled
to the controller for providing power to the controller, a force
transducer associated with a sensing conduit of the plurality of
sensing conduits and electrically coupled to the controller for
determining if a reduced-pressure threshold exists at a tissue site
associated with the sensing conduit, and an indicator coupled to
the controller for indicating when insufficient pressure exists in
an associated sensing conduit.
[0006] According to another illustrative embodiment, a method for
managing reduced pressure at a plurality of tissue sites undergoing
reduced pressure treatment on a patient includes providing a
reduced-pressure source, fluidly coupling a plurality of
reduced-pressure delivery conduits to the reduced-pressure source,
disposing a plurality of reduced-pressure dressings proximate to
the plurality of tissue sites, fluidly coupling the plurality of
reduced-pressure dressings to the plurality of reduced-pressure
delivery conduits in a one-to-one fashion, providing a plurality of
pressure management devices, and fluidly coupling a plurality of a
sensing conduits to the plurality of pressure management devices in
a one-to-one fashion. Each reduced-pressure dressing has a sensing
conduit of the plurality of sensing conduits and a reduced-pressure
delivery conduit of the plurality of reduced-pressure delivery
conduits associated with the reduced-pressure dressing. Each
pressure management device of the plurality of pressure management
devices may include a power unit electrically coupled to the
controller for providing power to the controller, a force
transducer associated with a sensing conduit of the plurality of
sensing conduits and electrically coupled to the controller for
determining if a reduced-pressure threshold exists at a tissue site
associated with the sensing conduit, and an indicator coupled to
the controller for indicating when insufficient pressure exists in
the associated sensing conduit.
[0007] According to another illustrative embodiment, a method of
manufacturing a system for managing reduced pressure at multiple
tissue sites undergoing reduced pressure treatment on a patient
includes providing a reduced-pressure source for providing reduced
pressure, providing a plurality of reduced-pressure delivery
conduits, fluidly coupling the plurality of reduced-pressure
delivery conduits to the reduced-pressure source, providing a
plurality of reduced-pressure dressings, providing plurality of
pressure management devices, providing a plurality of a sensing
conduits, and fluidly coupling the plurality of pressure management
devices in a one-to-one fashion to the plurality of sensing
conduits. Each reduced-pressure dressing has a sensing conduit of
the plurality of sensing conduits and a reduced-pressure delivery
conduit of the plurality of reduced-pressure delivery conduits
associated with the reduced-pressure dressing. Each pressure
management device of the plurality of pressure management devices
may include a power unit electrically coupled to the controller for
providing power to the controller, a force transducer associated
with a sensing conduit of the plurality of sensing conduits and
electrically coupled to the controller for determining if a
reduced-pressure threshold exists at a tissue site associated with
the sensing conduit, and an indicator coupled to the controller for
indicating when insufficient pressure exists in an associated
sensing conduit.
[0008] According to another illustrative embodiment, a system for
managing reduced pressure at multiple tissue sites undergoing
reduced pressure treatment on a patient includes a reduced-pressure
source for providing reduced pressure, a pressure management
module, a first conduit fluidly coupled between the
reduced-pressure source and the pressure management module, a
plurality of reduced-pressure delivery conduits fluidly coupled
between the pressure management module and a plurality of
reduced-pressure dressings. The plurality of reduced-pressure
dressings are coupled to the plurality of reduced-pressure delivery
conduits in a one-to-one fashion. The system further includes a
plurality of a sensing conduits fluidly coupled to the pressure
management module. Each reduced-pressure dressing has a sensing
conduit of the plurality of sensing conduits and a reduced-pressure
delivery conduit of the plurality of reduced-pressure delivery
conduits associated with the reduced-pressure dressing. The
pressure management module comprises a plurality of pressure
management devices. Each pressure management device of the
plurality of pressure management devices may include a power unit
electrically coupled to the controller for providing power to the
controller, a force transducer associated with a sensing conduit of
the plurality of sensing conduits and electrically coupled to the
controller for determining if a reduced-pressure threshold exists
at a tissue site associated with the sensing conduit, and an
indicator coupled to the controller for indicating when
insufficient pressure exists in an associated sensing conduit.
[0009] According to another illustrative embodiment, a system for
managing reduced pressure at multiple tissue sites undergoing
reduced pressure treatment on a patient includes a reduced-pressure
source for providing reduced pressure and a first plurality of
reduced-pressure delivery conduits fluidly coupled to the
reduced-pressure source. Each reduced-pressure delivery conduit of
the first plurality of reduced-pressure delivery conduits has a
first end and a second end. The second end of each of the first
plurality of reduced-pressure delivery conduits has a first
pressure-management connector coupled thereto. The system further
includes a second plurality of reduced-pressure delivery conduits,
each having a first end and a second end. The first end of the
second plurality of reduced-pressure delivery conduits has a second
pressure-management connector. The system further includes a
plurality of reduced-pressure dressings fluidly coupled to the
second plurality of reduced-pressure delivery conduits in a
one-to-one fashion. The first pressure management connector of the
plurality of reduced-pressure conduits is coupled to the second
pressure-management connector of the second plurality of
reduced-pressure in a one-to-one fashion. The first pressure
management connector and second management connector couple to form
a pressure management device, whereby the first pressure management
connectors and the second pressure management connectors form a
plurality of pressure management devices. Each reduced-pressure
dressing has one of the second reduced-pressure delivery conduits
associated with the reduced-pressure dressing. Each pressure
management device of the plurality of pressure management devices
includes a controller, a power unit electrically coupled to the
controller for providing power to the controller, a force
transducer associated with a sensing conduit of the first plurality
of reduced-pressure conduits and electrically coupled to the
controller for determining if a reduced-pressure threshold exists
at a tissue site associated with the sensing conduit, and an
indicator coupled to the controller for indicating when
insufficient pressure exists at the associated sensing conduit.
[0010] Other features and advantages of the illustrative
embodiments will become apparent with reference to the drawings and
detailed description that follow.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 is a schematic diagram, with a portion shown in cross
section, of an illustrative, non-limiting embodiment of a system
for managing reduced pressure at multiple tissue sites undergoing
reduced pressure treatment on a patient;
[0012] FIG. 2 is a schematic diagram of a portion of an
illustrative embodiment of a system for managing reduced pressure
at multiple tissue sites undergoing reduced pressure treatment on a
patient showing an illustrative, non-limiting configuration of a
pressure management device;
[0013] FIG. 3 is a schematic, elevation view of an illustrative
embodiment of an integral module formed from a plurality of
pressure management devices;
[0014] FIG. 4 is a schematic, elevation view of an illustrative
embodiment of an integral module that involves a conduit delivering
reduced pressure that is split to provide reduced pressure to a
plurality of reduced-pressure delivery conduits; and
[0015] FIG. 5 is a schematic, perspective view, with a portion
shown as a diagram and a portion as a cross section, of another
illustrative embodiment of a portion of a system for managing
reduced pressure at multiple tissue sites undergoing reduced
pressure treatment on a patient.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
[0016] In the following detailed description of the illustrative,
non-limiting embodiments, reference is made to the accompanying
drawings that form a part hereof. 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 embodiments described
herein, 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 illustrative embodiments are defined only by the appended
claims.
[0017] Reduced pressure provided to tissue sites encourages healing
at those tissue sites. To accommodate multiple tissue sites, e.g.,
multiple wounds on a patient, multiple conduits may be used to
deliver reduced pressure. A single reduced pressure source may be
used with the multiple conduits branched off one conduit. Pressure
monitoring is currently located in existing reduced-pressure
sources and only one conduit communicates pressure to the
reduced-pressure source. If only one conduit, which is associated
with one tissue site, is monitored, as is the case when monitoring
is done at the reduced-pressure source alone, pressure at other
tissue sites may be unmonitored. This means that the pressure at
the different tissue sites may vary greatly and yet go unnoticed.
This, in turn, may cause a detrimental result in some situations.
For example, if a graft does not receive reduced pressure for two
hours, the graft may not take. With the current system, each tissue
site of the plurality of tissue sites is monitored, and issues with
reduced pressure delivery may be identified and addressed. An
illustrative embodiment of a system 100 is presented that includes,
among other things, pressure monitoring at multiple tissue
sites.
[0018] Referring now to the drawings and initially to FIG. 1, the
system 100 for managing reduced pressure at a plurality of tissue
sites 102 that are undergoing reduced pressure treatment on a
patient 104 is presented. A plurality of reduced-pressure dressings
106 are used with the plurality of tissue sites 102. Typically, one
of the plurality of reduced-pressure dressings 106 is associated
with one of the plurality of tissue sites 102. The tissue sites 102
may comprise a single extended tissue site or wound or may be
discrete wound sites or tissue sites. Each of the tissue sites 102
may be the bodily tissue of any human, animal, or other organism,
including bone tissue, adipose tissue, muscle tissue, dermal
tissue, vascular tissue, connective tissue, cartilage, tendons,
ligaments, or any other tissue. Unless otherwise indicated, as used
throughout this document, "or" does not require mutual exclusivity.
Treatment of the tissue sites 102 may include removal of fluids,
e.g., exudate or ascites.
[0019] The plurality of reduced-pressure dressings 106 in the
illustrative embodiment of FIG. 1 is shown with a first
reduced-pressure dressing 108 and a second reduced-pressure
dressing 110. The plurality of reduced-pressure dressings 106 may
include any structure suitable for providing reduced pressure to a
tissue site and removing fluids. For example, in one illustrative
embodiment, the first reduced-pressure dressing 108 includes a
manifold 112 that is disposed proximate to one of the tissue sites
102 with which the manifold 112 is associated. The manifold 112 is
covered with a sealing member 114, which may include an attachment
device 116, that creates a fluid seal. A fluid seal is a seal
adequate to maintain reduced pressure at a desired tissue site
given the particular reduced-pressure source or subsystem involved.
The sealing member 114, which may include the attachment device
116, creates a sealed space 118 in which the manifold 112 may
reside. A reduced-pressure interface 120 may be placed through an
aperture (not shown) and the sealing member 114 to provide reduced
pressure into the sealed space 118 and in particular to the
manifold 112. For example, the reduced pressure interface 120 may
be a T.R.A.C..RTM. Pad or Sensa T.R.A.C..RTM. Pad available from
KCI of San Antonio, Tex. The reduced-pressure interface 120
delivers the reduced pressure to the sealed space 118. The second
reduced-pressure dressing 110 is analogous to the first
reduced-pressure dressing 108.
[0020] With respect to the manifold 112, a manifold is generally a
substance or structure that is provided to assist in applying
reduced pressure to, delivering fluids to, or removing fluids from
a tissue site, e.g., tissue site 102. The manifold 112 typically
includes a plurality of flow channels or pathways that distribute
fluids provided to and removed from the tissue site 102 around the
manifold 112. In one illustrative embodiment, the flow channels or
pathways are interconnected to improve distribution of fluids
provided or removed from the tissue site 102. The manifold 112
comprises one or more of the following: a biocompatible material
that is capable of being placed in contact with the tissue site 102
and distributing reduced pressure to the tissue site 102; devices
that have structural elements arranged to form flow channels, such
as, for example, cellular foam, open-cell foam, porous tissue
collections, liquids, gels, and foams that include, or cure to
include, flow channels; material that may be porous and may be made
from foam, gauze, felted mat, or any other material suited to a
particular biological application; foam with interconnected cells;
polyurethane; open-cell, reticulated foam such as GranuFoam.RTM.
material manufactured by Kinetic Concepts, Incorporated of San
Antonio, Tex.; bioresorbable material; or scaffold material. In
some situations, the manifold 112 may also be used to distribute
fluids such as medications, antibacterials, growth factors, and
various solutions to the tissue site 102. Other layers may be
included in or on the manifold 112, such as absorptive materials,
wicking materials, hydrophobic materials, and hydrophilic
materials.
[0021] In one illustrative embodiment, the manifold 112 may be
constructed from bioresorbable materials that do not have to be
removed from a patient's body following use of the reduced-pressure
dressing 108, 110. Suitable bioresorbable materials may include,
without limitation, a polymeric blend of polylactic acid (PLA) and
polyglycolic acid (PGA). The polymeric blend may also include
without limitation polycarbonates, polyfumarates, and
capralactones. The manifold 112 may further serve as a scaffold for
new cell-growth, or a scaffold material may be used in conjunction
with the manifold 112 to promote cell-growth. A scaffold is a
substance or structure used to enhance or promote the growth of
cells or formation of tissue, such as a three-dimensional porous
structure that provides a template for cell growth. Illustrative
examples of scaffold materials include calcium phosphate, collagen,
PLA/PGA, coral hydroxy apatites, carbonates, or processed allograft
materials.
[0022] The sealing member 114 may be any material that provides a
fluid seal. The sealing member 114 may, for example, be an
impermeable or semi-permeable, elastomeric material. Examples of
elastomers may include, but are not limited to, natural rubbers,
polyisoprene, styrene butadiene rubber, chloroprene rubber,
polybutadiene, nitrile rubber, butyl rubber, ethylene propylene
rubber, ethylene propylene diene monomer, chlorosulfonated
polyethylene, polysulfide rubber, polyurethane (PU), EVA film,
co-polyester, and silicones. Additional, specific examples of
sealing member materials include a silicone drape, 3M Tegaderm.RTM.
drape, polyurethane (PU) drape such as one available from Avery
Dennison Corporation of Pasadena, Calif.
[0023] The attachment device 116 may be used to hold the sealing
member 114 against the patient's epidermis 111 or another layer,
such as a gasket or additional sealing member, or another location.
The attachment device 116 may take numerous forms. For example, the
attachment device 116 may be a medically acceptable,
pressure-sensitive adhesive that extends about a periphery of the
sealing member 114.
[0024] The reduced-pressure dressings 106 provide reduced pressure
to the tissue sites 102. Reduced pressure is generally a pressure
less than the ambient pressure at a tissue site that is being
subjected to treatment. In most cases, this reduced pressure will
be less than the atmospheric pressure at which the patient is
located. Alternatively, the reduced pressure may be less than a
hydrostatic pressure at the tissue site. Unless otherwise
indicated, values of pressure stated herein are gauge pressures.
The reduced pressure delivered may be constant or varied (patterned
or random) and may be delivered continuously or intermittently.
Although the terms "vacuum" and "negative pressure" may be used to
describe the pressure applied to the tissue site, the actual
pressure applied to the tissue site may be more than the pressure
normally associated with a complete vacuum. Consistent with the use
herein, an increase in reduced pressure or vacuum pressure
typically refers to a relative reduction in absolute pressure.
[0025] A plurality of reduced-pressure delivery conduits 122 may be
fluidly coupled to a reduced-pressure source 124. The
reduced-pressure delivery conduits 122 may be conduits for carrying
reduced pressure and removing liquids alone or may be combined with
one or more lumens for sensing pressure and providing a vent or a
purge. For description purposes, a distinct plurality of sensing
conduits 126, or lumens, is shown associated with the plurality of
reduced-pressure delivery conduits 122, but it should be understood
that the sensing conduits 126 may be incorporated into the
plurality of reduced-pressure delivery conduits 122 as a lumen in a
multi-lumen conduit.
[0026] The reduced-pressure source 124 provides reduced pressure.
The reduced-pressure source 124 may be any device or source for
supplying a reduced pressure, such as a vacuum pump, wall suction,
micro-pump, or other source. If the reduced-pressure source 124 is
a micro-pump, the micro-pump may be directly coupled to the
plurality of management devices 128. While the amount and nature of
reduced pressure applied to a tissue site will typically vary
according to the application, the reduced pressure will typically
be between -5 mm Hg (-667 Pa) and -500 mm Hg (-66.7 kPa) and more
typically between -75 mm Hg (-9.9 kPa) and -300 mm Hg (-39.9 kPa).
For example, and not by way of limitation, the pressure may be -12,
-12.5, -13, -14, -14.5, -15, -15.5, -16, -16.5, -17, -17.5, -18,
-18.5, -19, -19.5, -20, -20.5, -21, -21.5, -22, -22.5, -23, -23.5,
-24, -24.5, -25, -25.5, -26, -26.5 kPa or another pressure.
[0027] The plurality of pressure management devices 128 may be
coupled to the plurality of reduced-pressure delivery conduits 122
and fluidly coupled to the plurality of sensing conduits 126. The
plurality of pressure management devices 128 may include, for
example, a first pressure management device 130 and a second
pressure management device 132. Each of the plurality of pressure
management devices 128 may include a housing 134. The housing 134
may include a visual indicator 136 that may include indicators such
as pressure disruption or caution symbol 138 and a touch mute
button 140. A manual power switch 142 may also be included on the
housing 134 or on the visual indicator 136. Each housing 134 may
include a first portion 144 and a second portion 146 or edge. A
first coupling member 148, which may include two components, may be
coupled to the first portion 144. A second coupling member 150 may
be formed on the second portion 146. The first coupling member 148
and the second coupling member 150 are sized and configured to
couple with one another either fixedley or releasably. As described
further below in connection with FIG. 3, the optional coupling
members 148, 150 allow the plurality of pressure management devices
128 to be combined to form an integral module, i.e., a single unit.
Other techniques and devices, e.g., fasteners or clips, may be used
to couple the pressure management devices 128.
[0028] Referring now primarily to FIG. 2, the system 100 for
managing reduced pressure at the plurality of tissue sites 102 is
presented in diagram form with only the first pressure management
device 130 of the plurality of pressure management devices 128
shown. It should be understood that any number of additional
pressure management devices 128 may be combined as part of the
system 100. Additional aspects of the first pressure management
device 130 may be explained in more detail with reference to FIG.
2.
[0029] The first pressure management device 130 is fluidly coupled
to one of the plurality of sensing conduits 126, and the sensing
conduit 126 is fluidly coupled to a force transducer 152 (or
pressure gauge) within the first pressure management device 130.
The force transducer 152 is able to develop a signal, e.g., an
electrical signal, that indicates the pressure within the sensing
conduit 126 or is otherwise able to detect various thresholds of
pressure. The force transducer 152 is coupled at 154 to a
controller 156. The controller 156 may be a printed wire assembly
(PWA) or an application specific integrated circuit (ASIC), a
microprocessor with associated memory, or other controller
device.
[0030] The controller 156 is able to thus monitor the pressure
within the sensing conduit 126 and thereby to monitor pressure
proximate to the tissue site 102. The controller 156 receives power
from a power unit 158, such as a battery or other source of
electrical power. The power unit 158 is coupled at 159 to the
controller 156. When the controller 156 determines that the reduced
pressure within the sensing conduit 126 is inadequate (e.g., below
a reduced-pressure threshold), such as may be caused by a leak in
the reduced-pressure dressing associated with the particular
sensing conduit 126 or a blockage or other problem, the controller
156 may activate or modify an indicator, such as an audible
indicator 160 (or alarm) or a visual indicator 162. The audible
indicator 160 is shown coupled at 161 to the controller 156. The
visual indicator 162 is shown coupled at 163 to the controller 156.
A mute switch or button 164 may be associated with the controller
156 and is shown coupled at 166. The mute switch 164 may allow a
user to silence the audible indicator 160. Other user interfaces
may be coupled to the controller 156 to control other aspects of
the first pressure management device 130.
[0031] A portion of the reduced-pressure delivery conduit 122 may
extend through the first pressure management device 130, and an
activation sensor or transducer 168 may be fluidly coupled to the
reduced-pressure delivery conduit 122. The activation sensor 168
can detect the presence of reduced pressure and provide a signal
170 to the controller 156. The controller 156 may compare the
pressure delivered through the reduced-pressure delivery conduit
122 with the sensing pressure in the sensing conduit 126 to make
certain determinations concerning performance and may also use the
signal from the activation sensor 168 to continue to run controller
156 and other aspects of the first pressure management device
130.
[0032] Referring now primarily to FIGS. 1 and 2, in operation,
according to one illustrative embodiment, a user may apply the
plurality of reduced-pressure dressings 106 to the plurality of
tissue sites 102. For example, the manifold 112 of the first
reduced-pressure dressing 108 may be placed against the tissue site
102 and then be covered by the sealing member 114 to create the
sealed space 118. A reduced pressure interface 120, if not already
installed, may be installed to provide reduced pressure to the
sealed space 118 or otherwise to the manifold 112. Other
reduced-pressure dressings may be applied to each tissue site 102
for which treatment is desired.
[0033] The plurality of reduced-pressure delivery conduits 122 may
be fluidly coupled to the reduced-pressure source 124 in a
one-to-one fashion. In this regard, the reduced-pressure source 124
may have a first conduit 172 (FIG. 1) that goes to a branching
member or splitter 174 that fluidly couples the plurality of
reduced-pressure delivery conduits 122 to the reduced-pressure
source 124. The plurality of sensing conduits 126 are fluidly
coupled to the plurality of pressure management devices 128.
[0034] The reduced-pressure source 124 is activated and begins to
deliver reduced pressure to the plurality of reduced-pressure
dressings 106. The plurality of pressure management devices 128 may
be activated either automatically by the activation sensors 168 or
manually by the user using an interface such as power switch 142.
Thus, reduced pressure is delivered to the tissue sites 102 and is
monitored for each tissue site 102. If there is a problem with the
reduced pressure delivery at a tissue site 102 as sensed by one of
the plurality of sensing conduits 126, the pressure management
device 128 associated with that particular sensing conduit of the
plurality of sensing conduits 126 will sense the inadequate
pressure via the associated force transducer 152. The controller
156, which monitors the force transducer 152, will then provide an
indication using the audible indicator 160 or the visual indicator
162. The user may then identify which reduced-pressure dressing of
the plurality of reduced-pressure dressings 106 is having the
difficulty. Corrective action may then be readily taken.
[0035] As shown in FIG. 3, the plurality of pressure management
devices 128 may be coupled using the first coupling members 148 and
the second coupling members 150 to form an integral module 176. The
integral module 176 provides for more convenient movement by the
user and may also be more aesthetic.
[0036] Referring now primarily to FIG. 4, an illustrative
embodiment of an integral module 176 or pressure management module
176 is presented that is analogous in most respects to the
integrated module 176 shown in FIG. 3. Accordingly, some parts are
labeled but not further described here. There are, however, two
main differences. First, the integrated module 176 of FIG. 4 may be
manufactured with three otherwise independent pressure management
devices is a single housing 178. Second, and related, the
integrated pressure management module 176 functions as a junction
or branching member or splitter to receive reduced pressure from a
first conduit 172 from a reduced-pressure source and to provide
reduced pressure to each of the plurality of pressure management
devices 128 for delivery through a plurality of reduced-pressure
delivery conduits 122. While not explicitly shown, associated with
or formed as part of the reduced-pressure delivery conduits 122 is
a plurality of pressure sensing lumens or conduits. The plurality
of sensing lumens allows the plurality of pressure management
devices to monitor pressure at a plurality of tissue sites. At
least one reduced-pressure delivery conduit 122 may be a sensing
lumen that provides pressure for sensing purposes to the
reduced-pressure source, e.g., reduced-pressure source 124 in FIG.
1.
[0037] Referring again primarily to FIG. 2, another illustrative
embodiment of system 100 will be presented. With respect to this
embodiment of system 100, the reduced pressure delivered by
reduced-pressure source 124 may be at a reduced pressure greater
(more negative on an absolute pressure scale) than required
anywhere in the system 100 and then stepped down to the desired
pressure at various locations. Thus, as an aspect of each of the
plurality of pressure management devices 128, a pressure regulating
valve 182 may be provided to adjust the reduced pressure delivered
from the reduced-pressure source 124 to the specific pressure
desired for a particular tissue site 102 associated with that
particular pressure management device.
[0038] The pressure regulating valve 182 may have an adjustment
control 184 for setting the desired pressure. Thus, as one example,
a single reduced-pressure source 124 may be used that provides
relatively higher reduced pressure (for example, but not by way of
limitation, -200 mm Hg) and then adjusted by the pressure
regulating valve 182 to a first desired pressure (e.g., but not by
way of limitation, to -150 mm Hg) and delivered to a tissue site
from which a graft has been taken. The system 100 also provides
reduced pressure to a reduced-pressure dressing at the tissue site
where the graft has been placed and may do so at a second desired
pressure that is relatively less than the first desired pressure
(e.g., but not by way of limitation, -50 mm Hg). In another
illustrative embodiment, the controller 156 may control the
adjustment control 184. The desired pressure may be set by a user
using a user interface to the controller 156.
[0039] Referring now primarily to FIG. 5, an illustrative,
non-limiting system 200 for managing reduced pressure at a
plurality of tissue sites, e.g., tissue site 202, undergoing
reduced pressure treatment on a patient 204 is presented. The
system 200 is analogous in many respects to the system 100 of FIG.
1. While only one reduced-pressure dressing 208 and one pressure
management device 228 is shown, it should be understand that the
system 200 contemplates a plurality of each. The plurality of
reduced-pressure dressings, such as reduced-pressure dressing 208,
is placed on the tissue sites, e.g., tissue site 202. With each
reduced-pressure dressing, a reduced-pressure interface 220 may be
used to provide reduced pressure to a sealed space 218 that
contains a manifold 212 and also allows for sensing of the pressure
in the sealed space 218.
[0040] A reduced-pressure source 224 delivers reduced pressure to a
first plurality of reduced-pressure delivery conduits 223. A first
conduit 272 may be used to deliver the reduced pressure to one or
more splitters 274 or distributors that are fluidly coupled to the
first plurality of reduced-pressure delivery conduits 223. Each of
the first reduced-pressure delivery conduits 223 has a first end
225 and a second end 227. Coupled to the second end 227 of each of
the first reduced-pressure delivery conduits 223 is a first
pressure management connector 286. A second pressure management
connector 288 is releasably coupled to the first pressure
management connector 286 to form a pressure management device 228.
A second plurality of reduced-pressure delivery conduits 290 may be
used to fluidly couple the reduced-pressure interface 220 to the
associated second pressure management connector 288 for each
reduced-pressure dressing. Each of the second plurality of
reduced-pressure delivery conduits 290 has a first end 292 and a
second end 294. The second pressure management connector 288 is
coupled to the first end 292 of the associated conduit of the
second plurality of reduced-pressure conduits 290.
[0041] Each pressure management device 228 created by coupling the
first pressure management connector 286 and the second pressure
management connector 288 provides both a fluid coupling and may
also function analogously to the pressure management devices 128 of
FIGS. 1-3 with respect to monitoring and control. The pressure
management devices 228 provide a quick connection and also readily
allow for one portion, e.g., the first pressure management
connector 286, to be reused and for another portion, e.g., the
second pressure management connector 288, to be discarded after
use. Physically coupling the connectors 286, 288 may also provide
an electrical connection between the connectors 286, 288. Referring
back to FIG. 2 again, various components of the first pressure
management device 130 may be associated with either of the
connectors 286, 288 of the pressure management device 228.
[0042] In one illustrative embodiment, the audible indicator 160
and visual indicator 162 may be associated with the first pressure
management connector 286. The controller 156, power unit 158, mute
switch 164, and force transducer 152 may be associated with the
second pressure management connector 288. Various combinations and
permutations of the components may be associated with the two
connectors 286, 288. The pressure regulating valve 182 may also be
associated with the second pressure management connector 288.
[0043] As used herein, the term "coupled" includes coupling via a
separate object and includes direct coupling. The term "coupled"
also encompasses two or more components that are continuous with
one another by virtue of each of the components being formed from
the same piece of material. Also, the term "coupled" may include
chemical, such as via a chemical bond, mechanical, thermal, or
electrical coupling. Fluid coupling means that fluid may be in
communication between the designated parts or locations.
[0044] In another illustrative embodiment, the pressure management
device may have no electronics and may use a physical device to
monitor pressure and to indicate inadequate pressure. For example,
a pop-up pressure valve may be associated with each sensing lumen
that is compressed under adequate reduced pressure, but expands and
is visible when inadequate reduced pressure exists.
[0045] The pressure management devices 128 may be used with any
reduced-pressure source, which may be any device for supplying a
reduced pressure, such as a vacuum pump, wall suction, or other
source. With the inclusion of a pressure regulating valve 182, the
pressure management devices 128 allow for a single reduced-pressure
source to supply and monitor reduced pressure at different
pressures at different tissue sites.
[0046] The reduced-pressure source may be a monitored system that
monitors one tissue site from which one conduit is fluidly coupled,
and the pressure management devices may be added to the additional
conduits associated with additional tissue sites.
[0047] Referring again generally to FIGS. 1 and 4, in another
illustrative embodiment, a system 100 for managing reduced pressure
at a plurality of tissue sites 102 that are undergoing reduced
pressure treatment on a patient 104 is presented. In this
illustrative embodiment, an integral module 176 has a plurality of
pressure management devices 128 similar to those presented in FIG.
4, but with only one controller (not explicitly shown) for the
integral module 176. The force transducers associated with each
pressure management device 128 are coupled to the one controller
for the integral module 176.
[0048] Although the present invention and its advantages have been
disclosed in the context of certain illustrative, non-limiting
embodiments, it should be understood that various changes,
substitutions, permutations, and alterations can be made without
departing from the scope of the invention as defined by the
appended claims. It will be appreciated that any feature that is
described in connection to any one embodiment may also be
applicable to any other embodiment.
[0049] It will be understood that the benefits and advantages
described above may relate to one embodiment or may relate to
several embodiments. It will further be understood that reference
to "an" item refers to one or more of those items.
[0050] The steps of the methods described herein may be carried out
in any suitable order, or simultaneously where appropriate.
[0051] Where appropriate, aspects of any of the embodiments
described above may be combined with aspects of any of the other
embodiments described to form further examples having comparable or
different properties and addressing the same or different
problems.
[0052] It will be understood that the above description of
preferred embodiments is given by way of example only and that
various modifications may be made by those skilled in the art. The
above specification, examples and data provide a complete
description of the structure and use of exemplary embodiments of
the invention. Although various embodiments of the invention have
been described above with a certain degree of particularity, or
with reference to one or more individual embodiments, those skilled
in the art could make numerous alterations to the disclosed
embodiments without departing from the scope of the claims.
* * * * *