U.S. patent application number 16/246692 was filed with the patent office on 2019-05-16 for systems and methods for collecting exudates in reduced-pressure therapy.
This patent application is currently assigned to KCI Licensing, Inc.. The applicant listed for this patent is KCI Licensing, Inc.. Invention is credited to Christopher Brian LOCKE, Benjamin Andrew PRATT.
Application Number | 20190142645 16/246692 |
Document ID | / |
Family ID | 49305092 |
Filed Date | 2019-05-16 |
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United States Patent
Application |
20190142645 |
Kind Code |
A1 |
LOCKE; Christopher Brian ;
et al. |
May 16, 2019 |
Systems And Methods For Collecting Exudates In Reduced-Pressure
Therapy
Abstract
In one example embodiment, a dressing connector is described
that provides a first fluid path between a first connector and a
second connector, and a second fluid path between a third connector
and a fourth connector. A liquid barrier may be disposed in the
first fluid path. The first fluid path and the second fluid path
are generally exposed to an exterior surface of the dressing
connector. In some embodiments, a tube may also be bonded to the
third connector to provide a third fluid path between the dressing
connector and another component. In more particular embodiments,
the liquid barrier may be a filter, such as a hydrophobic bacterial
filter, a sintered polymer filter, and/or a charcoal filter.
Inventors: |
LOCKE; Christopher Brian;
(Bournemouth, GB) ; PRATT; Benjamin Andrew;
(Poole, GB) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
KCI Licensing, Inc. |
San Antonio |
TX |
US |
|
|
Assignee: |
KCI Licensing, Inc.
San Antonio
TX
|
Family ID: |
49305092 |
Appl. No.: |
16/246692 |
Filed: |
January 14, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14023870 |
Sep 11, 2013 |
10219952 |
|
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16246692 |
|
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61700217 |
Sep 12, 2012 |
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Current U.S.
Class: |
604/319 ; 156/60;
29/428 |
Current CPC
Class: |
Y10T 29/49826 20150115;
Y10T 156/10 20150115; A61M 2209/086 20130101; A61M 1/0088 20130101;
A61M 1/0052 20140204; A61F 13/00068 20130101 |
International
Class: |
A61F 13/00 20060101
A61F013/00; A61M 1/00 20060101 A61M001/00 |
Claims
1.-20. (canceled)
21. A reduced-pressure treatment system comprising: a downstream
component; a container; a tube coupled to an upstream component;
and a dressing connector coupled to the container and to the tube;
wherein the dressing connector comprises a first fluid path between
the container and the downstream component, a second fluid path
between the container and the tube, and a liquid barrier disposed
in the first fluid path.
22. The reduced-pressure system of claim 21, wherein: the container
comprises a connector interface; the dressing connector comprises a
container interface; and the container interface is fluidly coupled
to the connector interface.
23. The reduced-pressure system of claim 21, wherein: the container
comprises two fittings; the dressing connector comprises two
receptacles; and the two receptacles are fluidly coupled to the two
fittings.
24. The reduced-pressure system of claim 21 or any of claims 22-23,
wherein the downstream component is a reduced-pressure source.
25. The reduced-pressure system of claim 21 or any of claims 22-24,
wherein the downstream component is a vacuum pump.
26. The reduced-pressure system of claim 21 or any of claims 22-25,
wherein the upstream component is a manifold.
27. The reduced-pressure system of claim 21 or any of claims 22-26,
wherein the container is a rigid canister comprising a drain port
and an alignment recess adapted to receive a longitudinal portion
of the tube.
28. The reduced-pressure system of claim 21, wherein: the
downstream component is a reduced-pressure source; the upstream
component is a manifold; the container is a rigid canister
comprising a drain port, an alignment recess adapted to receive a
longitudinal portion of the tube, and two fittings; the dressing
connector comprises two receptacles; and the two receptacles are
fluidly coupled to the two fittings.
29. The reduced-pressure system of claim 21 or any of claims 22-28,
wherein: the tube comprises a delivery lumen and a sensing lumen;
the dressing connector further comprises a third fluid path; the
second fluid path is in fluid communication with the delivery
lumen; and the third fluid path is in fluid communication with the
sensing lumen.
30. A system for collecting exudates in a reduced-pressure therapy
environment, the system comprising: a dressing connector
comprising: a first interface adapted to couple the dressing
connector to a downstream component, a second interface, a tube, a
first fluid path between the first interface and the second
interface, a second fluid path between the second interface and the
tube, and a liquid barrier in the first fluid path; and a container
comprising: a fluid chamber; a third interface fluidly coupled to
the fluid chamber, an alignment recess on an external surface, and
a drain port fluidly coupled to the fluid chamber; wherein the
second interface is adapted to couple to the third interface and
fluidly couple the first fluid path to the second fluid path
through the fluid chamber.
31. The system of claim 30, wherein: the second interface comprises
an inlet receptacle and an outlet receptacle; the third interface
comprises an inlet fitting and an outlet fitting; the inlet fitting
is adapted to sealingly engage the outlet receptacle; and the
outlet fitting is adapted to sealingly engage the inlet
receptacle.
32. The system of claim 31, wherein: the inlet fitting comprises an
inlet channel fluidly coupled to the fluid chamber; and the outlet
fitting comprises an outlet channel fluidly coupled to the fluid
chamber; whereby the first fluid path can be fluidly coupled to the
second fluid path through the inlet channel and the outlet
channel.
33. The system of claim 31 or claim 32, wherein: first interface
comprises a fitting; the first fluid path comprises a fluid channel
through the fitting; and the liquid barrier is in the first fluid
path between the inlet receptacle and the fluid channel.
34. The system of claim 30 or any of claims 31-32, wherein the
liquid barrier is a hydrophobic filter.
35. The system of claim 30 or any of claims 31-34, wherein: the
dressing connector further comprises an orientation recess; the
container further comprises an orientation fitting having a shape
and a depth adapted to engage the orientation recess and orient the
dressing connector such that the second interface is adapted to
sealingly engage the third interface in only one orientation.
36. The system of claim 30 or any of claims 31-35, wherein the
dressing connector further comprises a drain plug adapted to engage
and seal the drain port.
37. The method of operating a reduced-pressure therapy system, the
method comprising: coupling a dressing to a first dressing
connector; coupling the first dressing connector to a fluid
container and a reduced-pressure source, the first dressing
connector comprising a first liquid barrier between the fluid
container and the reduced-pressure source; applying
reduced-pressure from the reduced-pressure source to a tissue site
through the dressing; collecting exudate from the tissue site in
the fluid container; emptying exudate from the fluid container; and
replacing the first dressing connector with a second dressing
connector comprising a second liquid barrier.
38. The method of claim 37, wherein replacing the first dressing
connector comprises: removing the dressing from the tissue site;
removing the first dressing connector from the fluid container;
coupling a second dressing to the second dressing connector;
coupling the second dressing connector to the fluid container; and
coupling the second dressing connector to the reduced pressure
source.
39. The method of claim 37 or claim 38, wherein coupling the
dressing to the first dressing connector comprises coupling a tube
of the first dressing connector to the dressing.
40. A method of manufacturing a dressing connector, the method
comprising: forming a first interface comprising a first port, a
second port, a first receptacle, and a second receptacle; forming a
first channel from the first port to the first receptacle; forming
a second channel from the second port to the second receptacle;
coupling a tube to the first port; forming a second interface
comprising a third port and a fitting; forming a third channel from
the third port through the fitting; aligning the second port and
the third port; disposing a liquid barrier between the second port
and the third port; and coupling the first interface to the second
interface.
41. The method of claim 40, wherein coupling the tube to the first
port comprises bonding the tube to the first port with an
adhesive.
42. The method of claim 40, further comprising installing a one-way
valve between the first port and the first receptacle.
43. The method of claim 40, further comprising installing a
micropump within the dressing connector.
44. (canceled)
Description
RELATED APPLICATION
[0001] This application is a Divisional of U.S. application Ser.
No. 14/023,870, filed Sep. 11, 2013 which claims the benefit, under
35 USC .sctn. 119(e), of the filing of U.S. Provisional Patent
Application Ser. No. 61/700,217, entitled "SYSTEMS AND METHODS FOR
COLLECTING EXUDATES IN REDUCED-PRESSURE THERAPY" filed Sep. 12,
2012, which is incorporated herein by reference for all
purposes.
BACKGROUND
[0002] The present invention relates generally to tissue treatment
systems and more particularly to systems and methods for collecting
exudates in reduced-pressure therapy.
[0003] Clinical studies and practice have shown that reducing
pressure in proximity to a tissue site can augment and accelerate
growth of new tissue at the tissue site. The applications of this
phenomenon are numerous, but it has proven particularly
advantageous for treating wounds. Regardless of the etiology of a
wound, whether trauma, surgery, or another cause, proper care of
the wound is important to the outcome. Treatment of wounds with
reduced pressure may be commonly referred to as "reduced-pressure
wound therapy," but is also known by other names, including
"negative-pressure therapy," negative-pressure wound therapy," and
"vacuum therapy," for example Reduced-pressure therapy may provide
a number of benefits, including migration of epithelial and
subcutaneous tissues, improved blood flow, and micro-deformation of
tissue at a wound site. Together, these benefits can increase
development of granulation tissue and reduce healing times.
[0004] While the clinical benefits of reduced-pressure therapy are
widely known, the cost and complexity of reduced-pressure therapy
can be a limiting factor in its application, and the development
and operation of reduced-pressure systems, components, and
processes continues to present significant challenges to
manufacturers, healthcare providers, and patients.
BRIEF SUMMARY
[0005] In one example embodiment, a dressing connector is described
herein that provides a first fluid path between a first connector
and a second connector, and a second fluid path between a third
connector and a fourth connector. A liquid barrier may be disposed
in the first fluid path. The first fluid path and the second fluid
path are generally exposed to an exterior surface of the dressing
connector. In certain embodiments, the first connector may be a
fitting, the second connector may be a receptacle, the third
connector may be a port, and the fourth connector may be another
receptacle. In some embodiments, a tube may also be bonded to the
third connector to provide a third fluid path between the dressing
connector and another component. In more particular embodiments,
the liquid barrier may be a filter, such as a hydrophobic bacterial
filter, a gel-blocking sintered polymer filter, and/or a charcoal
filter.
[0006] Alternatively, an example embodiment may provide a fitting
fluidly coupled to a first receptacle through an inline liquid
barrier, a port fluidly coupled to a second receptacle, and a tube
fluidly coupled to the port. The fitting may be adapted to engage a
downstream component, such as a reduced-pressure source. The first
receptacle and the second receptacle each may provide a cavity
exposed to an exterior surface adapted to engage a container
fitting.
[0007] A reduced-pressure treatment system is also described
herein, wherein one example embodiment includes a downstream
component, such as a reduced-pressure source, a reusable container,
and a disposable dressing connector. The dressing connector may be
coupled to the container and to an upstream component, such as a
dressing. The dressing connector provides a first fluid path
between the downstream component and the container, and a second
fluid path between the container and the upstream component. A
liquid barrier can be disposed in the first fluid path between the
container and the downstream component. In some embodiments, a tube
may couple the dressing connector to the downstream component, the
upstream component, or both.
[0008] A method of manufacturing a dressing component is also
described herein, wherein one example embodiment includes forming a
first interface comprising a first port, a second port, a first
receptacle, and a second receptacle. A first channel may be formed
from the first port to the first receptacle. A second channel may
be formed from the second port to the second receptacle. A tube may
be coupled to the first port, such as by bonding the tube to the
first port with an adhesive. A second interface may be formed with
a third port and a fitting. The second port and the third port may
be aligned and a liquid barrier disposed between the second port
and the third port before coupling the first interface to the
second interface.
[0009] A method of operating a reduced-pressure system to provide
reduced-pressure therapy is also described. In one example method
of providing reduced-pressure therapy, a dressing may be coupled to
a first dressing connector. For example, a dressing may be applied
to a tissue site and a tube may be coupled to the dressing and to
the first dressing connector. The first dressing connector may then
be coupled to a reusable fluid container, such as by pressing
receptacles of the first dressing connector onto fittings of the
fluid container. In some embodiments, orientation recesses of the
first dressing connector may also be aligned with corresponding
orientation fittings on the fluid container. The fluid container
and the first dressing connector can then be coupled to a
reduced-pressure source or other downstream component, such that a
liquid barrier in the first dressing connector can be positioned
between the fluid container and the reduced-pressure source.
Reduced pressure can be applied to a tissue site through the
dressing.
[0010] Reduced-pressure may be applied and exudates collected from
the tissue site in the fluid container. Exudates may be emptied
from the fluid container and the first dressing connector may be
replaced with a second dressing connector having a second (and
preferably unused) liquid barrier. The first dressing connector can
be disposed of with the dressing, which encourages regular changes
of liquid barriers.
[0011] Other objects, features, and advantages of the embodiments
described herein will become apparent with reference to the
drawings and detailed description that follow.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIGS. 1A-1B are functional block diagrams of example
embodiments of a reduced-pressure therapy system that can collect
exudates in accordance with this specification;
[0013] FIG. 2 is a schematic diagram illustrating additional
details that may be associated with an example embodiment of the
reduced-pressure therapy system;
[0014] FIG. 3 is an exploded diagram illustrating additional
details that may be associated with an example embodiment of a
dressing connector that may be associated with the reduced-pressure
therapy system;
[0015] FIG. 4 is perspective view of a container that may be
associated with example embodiments of the reduced-pressure therapy
system;
[0016] FIG. 5 is a partial cross-sectional view of the dressing
connector of FIG. 3 and the container of FIG. 4 illustrating
additional details that may be associated with some embodiments of
the reduced-pressure therapy system;
[0017] FIG. 6 is a perspective view of another example embodiment
of a reduced-pressure therapy system;
[0018] FIG. 7 is a partial cross-sectional view of another example
embodiment of a dressing connector that may be associated with the
reduced-pressure therapy system; and
[0019] FIGS. 8A-8B are partial cross-sectional views of yet other
example embodiments of a dressing connector engaged with a canister
that may be associated with the reduced-pressure therapy
system.
DESCRIPTION OF EXAMPLE EMBODIMENTS
[0020] New and useful systems and methods for collecting exudates
in a reduced-pressure therapy environment are set forth in the
appended claims. Objectives, advantages, and a preferred mode of
making and using the systems and methods may be understood best by
reference to the following detailed description in conjunction with
the accompanying drawings. The description provides information
that enables a person skilled in the art to make and use the
claimed subject matter, but may omit certain details already
well-known in the art. Moreover, descriptions of various
alternatives using terms such as "or" do not necessarily require
mutual exclusivity unless clearly required by the context. The
claimed subject matter may also encompass alternative embodiments
not specifically described in detail. The following detailed
description is, therefore, to be taken as illustrative and not
limiting.
[0021] The example embodiments may also be described herein with
reference to spatial relationships between various elements or to
the spatial orientation of various elements depicted in the
attached drawings. In general, such relationships or orientation
assume a frame of reference consistent with or relative to a
patient in a position to receive treatment. However, as should be
recognized by those skilled in the art, this frame of reference is
merely a descriptive expedient rather than a strict
prescription.
[0022] FIGS. 1A-1B are simplified functional block diagrams of
example embodiments of a reduced-pressure therapy system 100 that
can collect exudates in accordance with this specification. As
illustrated, reduced-pressure therapy system 100 may include a
dressing 102 fluidly coupled to a reduced-pressure source 104. A
regulator or controller, such as regulator 106, may also be fluidly
coupled to dressing 102 and reduced-pressure source 104. Dressing
102 generally includes a drape, such as drape 108, and a manifold,
such as pressure distribution manifold 110. Reduced-pressure
therapy system 100 may also include fluid container, such as
container 112, coupled to dressing 102 and reduced-pressure source
104.
[0023] In general, components of reduced-pressure therapy system
100 may be coupled directly or indirectly. For example,
reduced-pressure source 104 may be directly coupled to regulator
106 and indirectly coupled to dressing 102 through regulator 106.
Components may be fluidly coupled to each other to provide a path
for transferring fluids (i.e., liquid and/or gas) between the
components. In some embodiments, components may be fluidly coupled
with a tube, for example. A "tube," as used herein, broadly refers
to a tube, pipe, hose, conduit, or other structure with one or more
lumina adapted to convey fluids between two ends. Typically, a tube
is an elongated, cylindrical structure with some flexibility, but
the geometry and rigidity may vary. In some embodiments, components
may additionally or alternatively be coupled by virtue of physical
proximity, being integral to a single structure, or being formed
from the same piece of material. Coupling may also include
mechanical, thermal, electrical, or chemical coupling (such as a
chemical bond) in some contexts.
[0024] In operation, pressure distribution manifold 110 may be
placed within, over, on, or otherwise proximate to a tissue site.
Drape 108 may be placed over pressure distribution manifold 110 and
sealed to tissue proximate the tissue site. The tissue proximate to
the tissue site is often undamaged epidermis peripheral to the
tissue site. Thus, dressing 102 can provide a sealed therapeutic
environment proximate to a tissue site, substantially isolated from
the external environment, and reduced-pressure source 104 can
reduce the pressure in the sealed therapeutic environment. Reduced
pressure applied uniformly through pressure distribution manifold
110 in the sealed therapeutic environment can induce macrostrain
and microstrain in the tissue site, as well as remove exudates and
other fluids from the tissue site, which can be collected in
container 112 and disposed of properly.
[0025] The fluid mechanics of using a reduced-pressure source to
reduce pressure in another component or location, such as within a
sealed therapeutic environment, can be mathematically complex.
However, the basic principles of fluid mechanics applicable to
reduced-pressure therapy are generally well-known to those skilled
in the art, and the process of reducing pressure may be described
illustratively herein as "delivering," "distributing," or
"generating" reduced pressure, for example.
[0026] In general, exudates and other fluids flow toward lower
pressure along a fluid path. This orientation is generally presumed
for purposes of describing various features and components of
reduced-pressure therapy systems herein. Thus, the term
"downstream" typically implies something in a fluid path relatively
closer to a reduced-pressure source, and conversely, the term
"upstream" implies something relatively further away from a
reduced-pressure source. Similarly, it may be convenient to
describe certain features in terms of fluid "inlet" or "outlet" in
such a frame of reference. However, the fluid path may also be
reversed in some applications (such as by substituting a
positive-pressure source for a reduced-pressure source) and this
descriptive convention should not be construed as a limiting
convention.
[0027] The term "tissue site" in this context broadly refers to a
wound or defect located on or within tissue, including but not
limited to, bone tissue, adipose tissue, muscle tissue, neural
tissue, dermal tissue, vascular tissue, connective tissue,
cartilage, tendons, or ligaments. A wound may include chronic,
acute, traumatic, subacute, and dehisced wounds, partial-thickness
burns, ulcers (such as diabetic, pressure, or venous insufficiency
ulcers), flaps, and grafts, for example. The term "tissue site" may
also refer to areas of any tissue that are not necessarily wounded
or defective, but are instead areas in which it may be desirable to
add or promote the growth of additional tissue. For example,
reduced pressure may be used in certain tissue areas to grow
additional tissue that may be harvested and transplanted to another
tissue location.
[0028] "Reduced pressure" generally refers to a pressure less than
a local ambient pressure, such as the ambient pressure in a local
environment external to a sealed therapeutic environment provided
by dressing 102. In many cases, the local ambient pressure may also
be the atmospheric pressure at which a patient is located.
Alternatively, the pressure may be less than a hydrostatic pressure
associated with tissue at the tissue site. Unless otherwise
indicated, values of pressure stated herein are gauge pressures.
Similarly, references to increases in reduced pressure typically
refer to a decrease in absolute pressure, while decreases in
reduced pressure typically refer to an increase in absolute
pressure.
[0029] A reduced-pressure source, such as reduced-pressure source
104, may be a reservoir of air at a reduced pressure, or may be a
manual or electrically-powered device that can reduced the pressure
in a sealed volume, such as a vacuum pump, a suction pump, a wall
suction port available at many healthcare facilities, or a
micro-pump, for example. The reduced-pressure source may be housed
within or used in conjunction with other components, such as
sensors, processing units, alarm indicators, memory, databases,
software, display devices, or user interfaces that further
facilitate reduced-pressure therapy. While the amount and nature of
reduced pressure applied to a tissue site may vary according to
therapeutic requirements, the pressure typically ranges between -5
mm Hg (-667 Pa) and -500 mm Hg (-66.7 kPa). Common therapeutic
ranges are between -75 mm Hg (-9.9 kPa) and -300 mm Hg (-39.9
kPa).
[0030] Pressure distribution manifold 110 can be generally adapted
to contact a tissue site. Pressure distribution manifold 110 may be
partially or fully in contact with the tissue site.
[0031] If the tissue site is a wound, for example, pressure
distribution manifold 110 may partially or completely fill the
wound, or may be placed over the wound. Pressure distribution
manifold 110 may take many forms, and may have many sizes, shapes,
or thicknesses depending on a variety of factors, such as the type
of treatment being implemented or the nature and size of a tissue
site. For example, the size and shape of pressure distribution
manifold 110 may be adapted to the contours of deep and irregular
shaped tissue sites.
[0032] More generally, a manifold is a substance or structure
adapted to distribute reduced pressure to and/or remove fluids from
a tissue site, or both. In some embodiments, though, a manifold may
also facilitate delivering fluids to a tissue site, if the fluid
path is reversed or a secondary fluid path is provided, for
example. A manifold may include flow channels or pathways that
distribute fluids provided to and removed from a tissue site around
the manifold. In one illustrative embodiment, the flow channels or
pathways may be interconnected to improve distribution of fluids
provided to or removed from a tissue site. For example, cellular
foam, open-cell foam, porous tissue collections, and other porous
material such as gauze or felted mat generally include structural
elements arranged to form flow channels. Liquids, gels, and other
foams may also include or be cured to include flow channels.
[0033] In one illustrative embodiment, pressure distribution
manifold 110 may be a porous foam material having interconnected
cells or pores adapted to uniformly (or quasi-uniformly) distribute
reduced pressure to a tissue site. The foam material may be either
hydrophobic or hydrophilic. In one non-limiting example, pressure
distribution manifold 110 can be an open-cell, reticulated
polyurethane foam such as GranuFoam.RTM. dressing available from
Kinetic Concepts, Inc. of San Antonio, Tex.
[0034] In an example in which pressure distribution manifold 110
may be made from a hydrophilic material, pressure distribution
manifold 110 may also wick fluid away from a tissue site, while
continuing to distribute reduced pressure to the tissue site. The
wicking properties of pressure distribution manifold 110 may draw
fluid away from a tissue site by capillary flow or other wicking
mechanisms. An example of a hydrophilic foam is a polyvinyl
alcohol, open-cell foam such as V.A.C. WhiteFoam.RTM. dressing
available from Kinetic Concepts, Inc. of San Antonio, Tex. Other
hydrophilic foams may include those made from polyether. Other
foams that may exhibit hydrophilic characteristics include
hydrophobic foams that have been treated or coated to provide
hydrophilicity.
[0035] Pressure distribution manifold 110 may further promote
granulation at a tissue site when pressure within the sealed
therapeutic environment is reduced. For example, any or all of the
surfaces of pressure distribution manifold 110 may have an uneven,
coarse, or jagged profile that can induce microstrains and stresses
at a tissue site if reduced pressure is applied through pressure
distribution manifold 110.
[0036] In one embodiment, pressure distribution manifold 110 may be
constructed from bioresorbable materials. 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. Pressure distribution manifold
110 may further serve as a scaffold for new cell-growth, or a
scaffold material may be used in conjunction with pressure
distribution manifold 110 to promote cell-growth. A scaffold is
generally 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.
[0037] Drape 108 is an example of a sealing member. A sealing
member may be constructed from a material that can provide a fluid
seal between two components or two environments, such as between a
therapeutic environment and a local external environment. The
sealing member may be, for example, an impermeable or
semi-permeable, elastomeric material that can provide a seal
adequate to maintain a reduced pressure at a tissue site for a
given reduced-pressure source. For semi-permeable materials, the
permeability generally should be low enough that a desired reduced
pressure may be maintained. An attachment device may be used to
attach a sealing member to an attachment surface, such as undamaged
epidermis, a gasket, or another sealing member. The attachment
device may take many forms. For example, an attachment device may
be a medically-acceptable, pressure-sensitive adhesive that extends
about a periphery, a portion, or an entire sealing member. Other
example embodiments of an attachment device may include a
double-sided tape, paste, hydrocolloid, hydrogel, silicone gel,
organogel, or an acrylic adhesive.
[0038] Container 112 is representative of a container, canister,
pouch, or other storage component that can be used to manage
exudates and other fluids withdrawn from a tissue site. In many
environments, a rigid container may be preferred or required for
collecting, storing, and disposing of fluids. In other
environments, fluids may be properly disposed of without rigid
container storage, and a re-usable container could reduce waste and
costs associated with reduced-pressure therapy. Liquid barriers are
usually an integral part of most reduced-pressure therapy
containers, though. For example, certain filters can reduce odor
and prevent exudates from entering the reduced-pressure source and
other components downstream from the container. In general, liquid
barriers allow air to flow from the container to the
reduced-pressure source while preventing contamination. However,
protein deposits can accumulate on the liquid barriers and
gradually reduce the volume of air flowing from the container,
which can adversely affect therapy and cause false blockage alarms.
Consequently, filters can be a limiting factor for re-using a
container.
[0039] As disclosed herein, reduced-pressure therapy system 100 can
overcome these shortcomings and others by providing a re-usable
container for collecting exudates that ensures filter changes at
regular intervals. For example, in some embodiments of
reduced-pressure therapy system 100, container 112 may be a
re-usable fluid container, and a single-use dressing connector,
such as connector 114, may couple container 112 to dressing 102 and
reduced-pressure source 104. In one particular embodiment, the
dressing connector includes an integrated, inline liquid barrier
and provides two pneumatic pathways. In general, the first
pneumatic pathway can connect the dressing to the fluid container,
and the second pneumatic pathway can connect the fluid container to
the reduced-pressure source or other downstream components, through
the liquid barrier. The dressing connector may also include a tube
having one end bonded or semi-permanently coupled to the first
pneumatic pathway. The other end of the tube can be connected to
the dressing during therapy. In some embodiments, the second
pneumatic pathway may be directly coupled to a reduced-pressure
source through a port adapted for mating with the reduced-pressure
source, while in other embodiments the second pneumatic pathway may
be indirectly coupled to a reduced-pressure source through one or
more intermediate components. The fluid container may also include
a drain port with a drain cover that may be removed and replaced.
The fluid container may be a rigid canister in some embodiments,
but may be a flexible container such as a soft-sided pouch in other
embodiments.
[0040] In general, reduced-pressure therapy may be applied until a
dressing requires replacement or therapy is complete. When the
dressing requires replacement or therapy is complete, the fluid
container may be emptied and the dressing connector (with the
integrated liquid barrier) can be disposed of with the dressing.
Consequently, the liquid barrier may only be used for a fixed
duration or for a fixed volume of exudates, which substantially
reduces or eliminates cross-contamination between patients (as a
dressing should not be used on multiple patients) and blockages due
to extended use by a single patient.
[0041] FIG. 2 is a schematic diagram illustrating additional
details that may be associated with an example embodiment of
reduced-pressure therapy system 100. In this example embodiment,
reduced-pressure therapy system 100 generally includes a dressing
202 fluidly coupled to a container, such as canister 204, through a
tube 206 and dressing connector 208. In some embodiments, a
dressing interface (not shown) may facilitate coupling dressing 202
and tube 206. For example, such a dressing interface may be a
T.R.A.C..RTM. Pad or Sensa T.R.A.C..RTM. Pad available from KCI of
San Antonio, Tex. In some embodiments, the dressing interface may
be a portion of tube 206 extending into the sealed therapeutic
environment, or may be a vacuum port on a micro-pump that extends
into the sealed therapeutic environment.
[0042] Dressing connector 208 in this example embodiment can be
directly coupled to a reduced-pressure source 210. Thus, canister
204 can be fluidly coupled to both dressing 202 and
reduced-pressure source 210. Canister 204 and reduced-pressure
source 210 may additionally be mechanically coupled to increase
stability, such as with a fastener or interlocking features. As
illustrated in FIG. 2, dressing 202 may be applied to a tissue site
212, and exudates 214 may be removed from the tissue site 212 and
collected in canister 204 as reduced-pressure therapy is applied.
In general, exudates and other fluids flow toward lower pressure
along a fluid path 216.
[0043] FIG. 3 is an exploded diagram illustrating additional
details that may be associated with an example embodiment of
dressing connector 208. In this example embodiment, dressing
connector 208 generally includes interfaces 302-304 and a liquid
barrier 306. Interface 302 may be generally described as a
"container interface" that provides connectors, fasteners, or
fittings adapted to mate with corresponding connectors, fasteners,
or fittings of another component, particularly a fluid container.
In FIG. 3, for example, interface 302 is illustrated with three
female connectors, i.e., receptacles 308-310 and a port 312, but
other combinations of male and female connectors are also possible.
Interface 302 may additionally provide one or more orientation
guides, such as orientation recesses 314a-314b. Receptacles
308-310, port 312, and orientation recesses 314a-314b are generally
exposed to an exterior surface 315 of dressing connector 208. For
example, in the example embodiment of FIG. 3, receptacles 308-310
are exposed on a first side of exterior surface 315 and port 312 is
exposed on a second, adjacent side.
[0044] In more particular embodiments, receptacles 308-310 may be
generally described as cavities exposed to exterior surface 315 and
adapted to receive and hold a male connector. In yet more
particular embodiments, receptacle 308 may be an inlet receptacle
adapted to receive fluid flow from an outlet fitting of a
container, and receptacle 310 may be an outlet receptacle adapted
to exhaust fluid flow into the container. A channel 316 may fluidly
couple receptacle 308 to an aperture 317, and a channel 318 may
fluidly couple receptacle 310 to port 312. Tube 206 may be bonded
or semi-permanently attached to port 312 to prevent separation
under expected therapeutic conditions. For example, tube 206 may be
bonded to port 312 with an adhesive, glue, or cement, or tube 206
and port 312 may be sized to provide a press fit.
[0045] Interface 304 may be generally described as a "downstream
interface" that provides an aperture 320 adapted for fluid
communication with channel 316 and a connector adapted to engage a
downstream component. In FIG. 3, for example, the connector is
represented as a fitting 322 that may be adapted to mechanically
couple with reduced-pressure source 210. In the illustrated
embodiment, fitting 322 is a male fitting (i.e., a part bearing one
or more protrusions) adapted to engage a female fitting or
receptacle, but in other embodiments, fitting 322 may be a female
fitting adapted to engage a male fitting, for example. Interface
304 may additionally include a recess 324 adapted to receive liquid
barrier 306.
[0046] In this example embodiment, tube 206 can be fluidly coupled
to port 312 (i.e., through a lumen in tube 206) and port 312 can be
fluidly coupled to receptacle 310 (i.e., through channel 318). When
assembled, aperture 320 may be aligned with aperture 317 to fluidly
couple fitting 322 to receptacle 316 through liquid barrier
306.
[0047] In more particular embodiments, liquid barrier 306 may be a
hydrophobic, bacterial filter. A charcoal filter may also be
co-located or placed inline with the hydrophobic, bacterial filter
to reduce odor. In yet more particular embodiments, liquid barrier
306 may be a gel-blocking sintered polymer filter that swells on
contact with water, which can block the fluid path between a
reduced-pressure source and a canister. Suitable polymers include,
for example, fluoropolymers such as polytetrafluoroethylene (PTFE),
polyvinylidene fluoride (PVdF), or fluorinated ethylenepropylene
(FEP); chlorofluoropolymers, such as polychlorotrifluoroethylene
(PCTFE); polyolefins such as high density polyethylene (HDPE),
polypropylene (PP), cyclic olefin copolymer (COC), or
polymethylpent-1-ene (PMP); polyvinyl acetate (PVAc) or ethylene
vinyl acetate (EVA); polycarbonate (PC); polyesters such as
polyethylene terephthalate (PET) or PET copolymers (PETG); or
polysulphones or polyethersulphones. The polymer may also contain
charcoal to reduce odor. Additionally, filters may be coated to
enhance hydrophobicity in some embodiments. Polymers may be formed
into membranes or sintered (particularly for PVAc, EVA,
polyolefin's, and fluoropolymers).
[0048] In the example embodiment of FIG. 3, interface 302 and
interface 304 are illustrated as separate components that may be
bonded together to enclose liquid barrier 306. In other
embodiments, dressing connector 208 may be fabricated from a single
mold in which interface 302 and interface 304 form a unitary
structure. Liquid barrier 306 in this instance may be formed from a
sintered polymer, for example, that can be inserted into port 322
of the unitary structure consisting of 302 and 304. This type of
assembly may also suit a more common sheet filter welded or glued
to a molded carrier that can also be pushed into port 322. Liquid
barrier 306 may also be welded or glued directly to a singular
unitary structure consisting of 302 and 304.
[0049] In an example embodiment of manufacturing a dressing
connector such as dressing connector 208, a first interface (such
as interface 302) may be formed with a first port (such as port
312), a second port, a first receptacle (such as receptacle 310),
and a second receptacle (such as receptacle 308). A first channel,
such as channel 318, may be formed from the first port to the first
receptacle. A second channel, such as channel 316, may be formed
from the second port to the second receptacle. A tube such as tube
206 may be coupled to the first port, such as by bonding the tube
to the first port with an adhesive. A second interface (such as
interface 304) may be formed with a third port (such as aperture
320) and a fitting (such as fitting 322). The second port and the
third port may be aligned and a liquid barrier disposed between the
second port and the third port before coupling the first interface
to the second interface.
[0050] FIG. 4 is a perspective view of a container that may be
associated with example embodiments of reduced-pressure therapy
system 100. In this example embodiment, the container may be a
rigid canister 400 that generally includes an interface 402, an
alignment recess 404, a drain port 406, and a drain cover 408.
Interface 402 may be described as a "connector interface" that can
be recessed in the body 414 of rigid canister 400 and adapted for
fluidly coupling with a dressing connector, such as interface 302
of dressing connector 208. For example, interface 402 may provide
fittings 410-412, which can be adapted for coupling to receptacles
308-310, and may be dimensioned and recessed within body 414 of
canister 400 to minimize the profile of dressing connector 208.
Similarly, alignment recess 404 may be dimensioned to receive tube
206 to minimize the profile of tube 206. More particularly, in one
embodiment, alignment recess 404 may have a depth that is
substantially equivalent to an outside diameter of a longitudinal
portion of tube 206. In some embodiments, rigid canister 400 may
additionally include orientation fittings (not shown) adapted to
mate with orientation recesses 314a-314b to facilitate proper
orientation of dressing connector 208. In more particular
embodiments, fitting 410 may be an outlet fitting adapted to
sealingly engage and exhaust fluid flow to an inlet receptacle of a
dressing connector, and fitting 412 may be an inlet fitting adapted
to sealingly engage and receive fluid flow from a dressing
connector, such as dressing connector 208. In the particular
example embodiment illustrated in FIG. 4, canister 400 also
provides a shoulder 416, a ridge 418 fixed to shoulder 416, and an
end surface 418. Shoulder 416 and ridge 418 are adapted to abut a
counterpart ridge and shoulder, respectively, on another component,
such as a reduced-pressure source. Thus, shoulder 416 and ridge 418
can be used as a structural support for coupling to other
components, as well as providing clearance for drain port 406 and
drain cover 408 positioned on end surface 418, as shown in FIG.
4.
[0051] In one example method of providing reduced-pressure therapy,
a dressing may be coupled to a first dressing connector. For
example, a dressing may be applied to a tissue site and tube 206
may be coupled to the dressing and to dressing connector 208.
Dressing connector 208 may then be coupled to canister 400, such as
by pressing receptacles 308-310 onto fittings 410-412,
respectively. In some embodiments, orientation recesses 314a-314b
may also be aligned with corresponding orientation fittings on
canister 400. Canister 400 and dressing connector 208 can then be
coupled to reduced-pressure source 210, such that liquid barrier
306 is disposed in the fluid path between canister 400 and
reduced-pressure source 210. Tube 206 may be placed in alignment
recess 404, and therapy may be initiated (reduced-pressure source
210 may be activated and reduced pressure applied through the
dressing, for example). In some embodiments, reduced-pressure
therapy system 100 may include a leak detector and can be
programmed to activate an alarm or alert if drain cover 408 is not
replaced properly or if dressing connector 208 is not properly
coupled to reduced-pressure source 210.
[0052] Reduced-pressure may be applied and exudates collected from
the tissue site in canister 400 until canister 400 is substantially
full, the dressing needs changing, or therapy is complete, for
example. Exudates may be emptied from canister 400, and dressing
connector 208 may be replaced with a second dressing connector
having a second (and preferably unused) liquid barrier. For
example, the dressing may be removed from the tissue site, and
dressing connector 208 may be removed from canister 400. A second
dressing can be coupled to the second dressing connector, which can
be coupled to canister 400 and reduced-pressure source 210.
Dressing connector 208 (with liquid barrier 306) can (and should)
be disposed of with the dressing, which encourages regular changes
of liquid barrier 306.
[0053] These operations are merely illustrative, however, and some
of these operations may be consolidated or omitted, where
appropriate, and these operations may be modified or changed
considerably without departing from the scope of teachings provided
herein. In addition, a number of these operations may be executed
concurrently with, or in parallel to, one or more additional
operations. The sequence of these operations may be altered
considerably, as reduced-pressure therapy system 100 provides
substantial flexibility.
[0054] FIG. 5 is a partial cross-sectional view of dressing
connector 208 and canister 400 illustrating additional details that
may be associated with some embodiments of reduced-pressure therapy
system 100. Dressing connector 208 is shown engaged with canister
400 in FIG. 5, such that fittings 410-412 are inserted into
receptacles 308-310, respectively. In the example embodiment of
FIG. 5, receptacles 308-310 and fittings 410-412 are tapered
(chamfered) to guide the relative movement between receptacles
308-310 and fittings 410-412. Receptacles 308-310 may also provide
recesses 502-504 adapted to engage and retain ridges 506-508 on
fittings 410-412. In some embodiments, recesses 502-504 and ridges
506-508 may be annular recesses and ridges. In other example
embodiments, ridges 506-508 may be flexible pins or pegs. In some
embodiments, only a single pin or peg may be preferable, while in
other embodiments several pins or pegs may be annularly spaced
(regularly or irregularly) about fittings 410-412. Additionally or
alternatively, recesses 502-504 and ridges 506 may be configured to
allow dressing connector 208 to engage canister 400 in only one
orientation. Recesses 502-504 may be adapted to mate with ridges
506-508 accordingly. Fitting 322 may also provide a chamfered
surface and a ridge 510 adapted to engage a receptacle 512, which
may be associated with a conduit to or a housing of a
reduced-pressure source or other downstream component, for
example.
[0055] When engaged, as illustrated in the example embodiments of
FIG. 5, dressing connector 208 and canister 400 provide fluid path
216 between an upstream component, such as a dressing, and
receptacle 512. Fluid path 216 in this example can be generally
described as having several parts. For example, a lumen through
tube 206 provides a fluid path between the upstream component and
port 312, and channel 318 provides a fluid path between port 312
and receptacle 310. A channel 516 through fitting 412, a chamber
518 in canister 400, and a channel 520 through fitting 410 provide
a fluid path between receptacle 310 and receptacle 308. Channel 316
and a channel 522 through fitting 322 provide a fluid path between
receptacle 308 and an aperture 524 exposed on exterior surface 315.
Liquid barrier 306 in this example can be disposed inline, i.e., in
fluid path 216, between aperture 317 and aperture 320. The
components of dressing connector 208 and canister 400 are
preferably adapted to provide an airtight seal when coupled. For
example, fittings 410-412 and receptacles 308-310 may be sized to
provide a press fit or an interference fit that substantially seals
fluid path 216 from external environments.
[0056] FIG. 6 is a perspective view of an example embodiment of a
reduced-pressure therapy system 600. This example embodiment
illustrates a reduced-pressure source 602 adapted to mate with a
canister 604 to provide a convenient system for applying
reduced-pressure therapy. A fluid connection between
reduced-pressure source 602 and canister 604 may be provided
through a dressing connector 606. Moreover, dressing connector 606
may be adapted to fit in a recess of reduced-pressure source 602
and canister 604 to minimize the profile of the assembly. Tubing
608 may similarly be adapted to fit in a recess of canister 604 to
minimize the profile of the assembly, as well as provide additional
stability of the fluid connection.
[0057] FIG. 7 is a partial cross-sectional view of another example
embodiment of a dressing connector, illustrated as dressing
connector 702. Dressing connector 702 is illustrated engaged with a
canister, such as canister 400. Dressing connector 702 may be
similar to dressing connector 208 in many respects, but may also
provide one or more feedback or sensing conduits, such as sensing
conduit 704, which can fluidly connect a dressing to a controller
or regulator, such as regulator 106. The controller or regulator
regulate pressure in the dressing, and may also be adapted to
detect improper connections, such as an inadequate connection
between the dressing connector and the reduced-pressure source, or
an inadequate seal between the drain port and the drain cover. As
illustrated, dressing connector 702 can provide fluid path 216
between a downstream component and an upstream component, and also
provides another fluid path 706. Fluid path 706 may include, for
example, sensing conduit 704 fluidly coupled to a sensing lumen 708
in a multi-lumen tube 710, which can be coupled to a dressing or
other upstream component. Fluid path 216 may include a delivery
lumen 712 in multi-lumen tube 710 between the upstream component
and port 312.
[0058] FIGS. 8A-8B are partial cross-sectional views of yet other
example embodiments of a dressing connector engaged with a
canister. In these examples, a dressing connector 802 is
illustrated engaged with a canister, such as canister 400. Dressing
connector 802 may be similar to dressing connector 208 and dressing
connector 702 in many respects, but is illustrative of an
alternative positioning of liquid barrier 804a-804b in fluid path
216. In some embodiments, liquid barrier 804a-804b may be formed
from a sintered polymer. Dressing connector 802 in this example may
be a unitary structure, and liquid barrier 804a-804b may be welded
or glued to port 302. For example, an adhesive may be applied to an
exterior surface of liquid barrier 804a, which may be inserted into
port 322. Alternatively or additionally, an adhesive may be applied
to an exterior surface and/or an interior surface of port 322
before receiving liquid barrier 804a. In other embodiments, liquid
barrier 804a may be coupled to port 322 with an interference fit.
Adhesive may also be applied to an exterior surface of liquid
barrier 804b and/or port 322 to secure liquid barrier 804b in
position. Thus, liquid barriers 804a-804b may be disposed in fluid
path 216, but may be disposed at least partially external to
dressing connector 208, which may reduce part count and
manufacturing complexity.
[0059] Yet other components may be provided in alternative or
additional embodiments. For example, a secondary inline filter may
also be provided downstream of the dressing connector. A one-way
control valve may be included to control the flow of exudates from
the wound, which may be particularly advantageous while emptying
the canister to prevent exudates in the tube and air from the
surrounding environment from being drawn into the wound. A Vortis
pump may additionally be integrated into the dressing connector,
which can maintain reduced pressure after drawdown to significantly
extend the life of the reduced-pressure therapy system.
[0060] In another example embodiment, a drain plug or cover may be
integrated with the dressing connector such that the dressing
connector must be removed to empty fluid from the canister. The
dressing connector may also provide a sacrificial fastener adapted
to be broken or rendered inoperable in the process of either
fitting the dressing connector to the canister or removing the
dressing connector from the canister so that the dressing connector
may not be re-used.
[0061] The systems and methods described herein may provide
significant advantages, some of which have already been mentioned.
For example, reduced-pressure therapy system 100 provides a
canister that can be re-used, which in turn can lead to significant
reduction in cost and environmental impact over the duration of
therapy. Moreover, such a canister may be manufactured through a
low-cost process such as blow molding, substantially reducing
errors in welding filters and potentially leading to yet additional
cost savings. Reduced-pressure therapy system may also provide
redundant liquid barriers, while promoting regular replacement of
the primary liquid barrier without adding a mental burden to
therapy.
[0062] It should be apparent from the foregoing that an invention
having significant advantages has been provided. While shown in
only a few forms, the systems and methods illustrated are
susceptible to various changes and modifications without departing
from the spirit thereof.
* * * * *